Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

Self-Shielded Irradiator Licenses

Draft Report for Comment

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 5, Rev. 1

Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

Self-Shielded Irradiator Licenses

Draft Report for Comment

Manuscript Completed: January 2017

Date Published: January 2017

Prepared by: 

S. T. Hammann

J. F. Katanic

J. Moak

K. D. Modes

L. Roldán-Otero

G. M. Warren

Office of Nuclear Material Safety and Safeguards

 

NUREG-1556

Volume 5, Rev. 1
1 COMMENTS ON DRAFT REPORT 

2 Any interested party may submit comments on this report for consideration by the NRC staff. 

3 Comments may be accompanied by additional relevant information or supporting data. Please 

4 specify the report number NUREG-1556, Volume 5, Revision 1, in your comments, and send 

5 them by the end of the comment period specified in the Federal Register notice announcing the 

6 availability of this report. 

7 Addresses: You may submit comments by any one of the following methods. Please include 

8 Docket ID NRC-2016-0095 in the subject line of your comments. Comments submitted in 

9 writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking 

10 Web site at http://www.regulations.gov. 

11 Federal Rulemaking Web site: Go to http://www.regulations.gov and search for documents 

12 filed under Docket ID NRC-2016-0095. Address questions about NRC dockets to 

13 Carol Gallagher at 301-415-3463 or by e-mail at Carol.Gallagher@nrc.gov. 

14 Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch 

15 (RADB), Division of Administrative Services, Office of Administration, Mail Stop: 

16 OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. 

17 For any questions about the material in this report, please contact: Celimar Valentin-Rodriguez, 

18 Chemical Engineer at 301-415-7124 or by e-mail at Valentin-Rodriguez.Celimar@nrc.gov. 

19 Please be aware that any comments that you submit to the NRC will be considered a public 

20 record and entered into the Agencywide Documents Access and Management System

21 (ADAMS). Do not provide information you would not want to be publicly available.
iii 

1 ABSTRACT 

2 This technical report contains information intended to provide program-specific guidance and 

3 assist applicants and licensees in preparing applications for materials licenses for self-shielded 

4 irradiators. In particular, it describes the types of information needed to complete U.S. Nuclear 

5 Regulatory Commission (NRC) Form 313, “Application for Materials License.” This document 

6 describes both the methods acceptable to the NRC license reviewers in implementing the 

7 regulations and the techniques used by the reviewers in evaluating the application to determine 

8 if the proposed activities are acceptable for licensing purposes. 

9 This NUREG contains information collection requirements that are subject to the Paperwork 

10 Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved 

11 by the Office of Management and Budget, approval numbers 3150-0044, 3150-0014, 3150-

12 0035, 3150-0017, 3150-0010, 3150-0001, 3150-0214, 3150-0008, 3150-0036, 3150-0027, 

13 3150-0028, and 3150-0120. 

14 The NRC may not conduct or sponsor, and a person is not required to respond to, a request for 

15 information or an information collection requirement unless the requesting document displays a 

16 currently valid OMB control number. 

Paperwork Reduction Act Statement

Public Protection Notification

v 

1 FOREWORD 

2 The U.S. Nuclear Regulatory Commission’s (NRC’s) NUREG–1556 technical report series 

3 provides a comprehensive source of reference information about various aspects of materials 

4 licensing and materials program implementation. These reports, where applicable, describe a 

5 risk-informed, performance-based approach to licensing consistent with the current regulations. 

6 The reports are intended for use by applicants, licensees, license reviewers, and other NRC 

7 personnel. The NUREG–1556 series currently includes the following volumes: 

Volume No. Volume Title 

1 Program-Specific Guidance About Portable Gauge Licenses 

2 Program-Specific Guidance About Industrial Radiography Licenses 

3 Applications for Sealed Source and Device Evaluation and Registration 

4 Program-Specific Guidance About Fixed Gauge Licenses 

5 Program-Specific Guidance About Self-Shielded Irradiator Licenses 

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

7 Program-Specific Guidance About Academic, Research and Development, and 

Other Licenses of Limited Scope Including Electron Capture Devices and X-Ray 

Fluorescence Analyzers 

8 Program-Specific Guidance About Exempt Distribution Licenses 

9 Program-Specific Guidance About Medical Use Licenses 

10 Program-Specific Guidance About Master Materials Licenses 

11 Program-Specific Guidance About Licenses of Broad Scope 

12 Program-Specific Guidance About Possession Licenses for Manufacturing 

and Distribution 

13 Program-Specific Guidance About Commercial Radiopharmacy Licenses 

14 Program-Specific Guidance About Well Logging, Tracer, and Field Flood 

Study Licenses 

15 Guidance about Changes of Control and About Bankruptcy Involving Byproduct, 

Source, or Special Nuclear Materials Licenses 

16 Program-Specific Guidance About Licenses Authorizing Distribution to 

General Licensees 

17 Program-Specific Guidance About Special Nuclear Material of Less Than 

Critical Mass Licenses 

18 Program-Specific Guidance About Service Provider Licenses 

19 Guidance for Agreement State Licensees About NRC Form 241 “Report of 

Proposed Activities in Non-Agreement States, Areas of Exclusive Federal 

Jurisdiction, or Offshore Waters” and Guidance for NRC Licensees Proposing to 

Work in Agreement State Jurisdiction (Reciprocity) 

20 Guidance About Administrative Licensing Procedures 

21 Program-Specific Guidance About Possession Licenses for Production of 

Radioactive Material Using an Accelerator 

8 The current document, NUREG-1556, Volume 5, Revision 1, “Consolidated Guidance About 

9 Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses,” is 

10 intended for use by applicants, licensees, and NRC staff. This revision provides a general 

11 update to the previous information contained in NUREG-1556, Volume 5, dated October 1998. 
vi 

1 This report takes a risk-informed, performance-based approach to licensing self-shielded 

2 irradiators. A team composed of staff from NRC Headquarters, NRC regional offices, and 

3 Agreement States prepared this document, drawing on their collective experience in radiation 

4 safety in general and as specifically applied to self-shielded irradiators. 

5 NUREG-1556, Volume 5, Revision 1, is not a substitute for NRC or Agreement State 

6 regulations. The approaches and methods described in this NUREG are provided for 

7 information only. Methods and solutions different from those described in this NUREG may be 

8 acceptable if they include a basis for the staff to make the determinations needed to issue or 

9 renew a license. 

10 

11 Daniel S. Collins, Director 

12 Division of Material Safety, State, Tribal and Rulemaking Programs 

13 Office of Nuclear Material Safety and Safeguards
vii 

1 TABLE OF CONTENTS 

2 ABSTRACT ................................................................................................................................. iii 

3 FOREWORD ................................................................................................................................. v 

4 FIGURES ..................................................................................................................................... xi 

5 TABLES ....................................................................................................................................... xi 

6 ACKNOWLEDGMENTS ............................................................................................................ xiii 

7 ABBREVIATIONS ...................................................................................................................... xv 

8 1 PURPOSE OF REPORT ................................................................................................ 1-1

9 2 AGREEMENT STATES ................................................................................................. 2-1

10 2.1 Jurisdiction Determination .................................................................................. 2-1

11 2.2 Reciprocal Recognition of Specific Licenses ...................................................... 2-3

12 3 MANAGEMENT RESPONSIBILITY .............................................................................. 3-1

13 3.1 Commitments and Responsibilities .................................................................... 3-1

14 3.2 Safety Culture ..................................................................................................... 3-2

15 4 APPLICABLE REGULATIONS ..................................................................................... 4-1

16 5 HOW TO FILE ................................................................................................................ 5-1

17 5.1 Application Preparation ...................................................................................... 5-1

18 5.2 Where to File ...................................................................................................... 5-1

19 5.3 Paper Applications ............................................................................................. 5-2

20 5.4 Electronic Applications ....................................................................................... 5-2

21 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION ................................. 6-1

22 7 APPLICATION AND LICENSE FEES ........................................................................... 7-1

23 8 CONTENTS OF AN APPLICATION .............................................................................. 8-1

24 8.1 Item 1: License Action Type .............................................................................. 8-1

25 8.2 Item 2: Name and Mailing Address of Applicant................................................ 8-2

26 8.2.1   Notification of Bankruptcy Proceedings ................................................. 8-2

27 8.3 Item 3: Address(es) Where Licensed Material Will Be Used 

28 or Possessed ......................................................................................... 8-3

29 8.4 Item 4: Person To Be Contacted about This Application ................................... 8-4

30 8.5 Item 5: Radioactive Material .............................................................................. 8-4

31 8.5.1   Sealed Sources and Devices ................................................................. 8-4

32 8.5.2   Financial Assurance and Recordkeeping for Decommissioning ............ 8-6

33 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used .......................... 8-8

34 8.7 Item 7: Individual(s) Responsible for the Radiation Safety Program and 

35 Their Training Experience .................................................................... 8-10

36 8.7.1 Radiation Safety Officer (RSO) ............................................................. 8-10

37 8.7.2 Authorized Users (AUs) ........................................................................ 8-12

38 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted 

39 Areas (Instructions to Occupational Workers and Ancillary 

40 Personnel) ............................................................................................ 8-12

41 8.8.1 Instructions to Occupationally Exposed Radiation Workers ................. 8-12

42 8.8.2 Instructions to Ancillary Workers .......................................................... 8-14
viii 

1 8.9 Item 9: Facilities and Equipment .................................................................... 8-14

2 8.10 Item 10: Radiation Safety Program .................................................................. 8-17

3 8.10.1 Audit and Review of Program ............................................................ 8-17

4 8.10.2 Radiation Monitoring Instruments ...................................................... 8-19

5 8.10.3 Material Receipt and Accountability ................................................... 8-21

6 8.10.3.1 Inventory ....................................................................... 8-21

7 8.10.3.2 National Source Tracking System (NSTS) .................... 8-22

8 8.10.3.3 Decommissioning Records ........................................... 8-23

9 8.10.4 Occupational Dose ............................................................................ 8-24

10 8.10.5 Public Dose ........................................................................................ 8-27

11 8.10.6 Operating, Emergency, and Security Procedures ............................. 8-29

12 8.10.6.1 Operating and Emergency Procedures ......................... 8-29

13 8.10.6.2 Security Program for Category 1 and Category 2 

14 Radioactive Material ...................................................... 8-33

15 8.10.7 Leak Tests ......................................................................................... 8-34

16 8.10.8 Maintenance ...................................................................................... 8-35

17 8.10.9 Transfer and Transportation .............................................................. 8-39

18 8.11 Item 11: Waste Management .......................................................................... 8-43

19 8.11.1 Self-Shielded Irradiator Transfer and Disposal .................................. 8-43

20 8.12 Item 12: License Fees ..................................................................................... 8-45

21 8.13 Item 13: Certification ....................................................................................... 8-45

22 9 LICENSE AMENDMENTS AND RENEWALS ............................................................... 9-1

23 9.1 Timely Notification of Transfer of Control ........................................................... 9-1

24 10 APPLICATIONS FOR EXEMPTIONS ......................................................................... 10-1

25 11 TERMINATION OF ACTIVITIES ................................................................................. 11-1

26 APPENDICES 

27 APPENDIX A U.S. NUCLEAR REGULATORY COMMISSION FORM 313 ................ A-1 

28 APPENDIX B SUGGESTED FORMAT FOR PROVIDING INFORMATION 

29 REQUESTED IN ITEMS 5 THROUGH 11 OF NRC 

30 FORM 313 ............................................................................................. B-1 

31 APPENDIX C SAFETY CULTURE POLICY STATEMENT ......................................... C-1 

32 APPENDIX D CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

33 INFORMATION FROM PUBLIC DISCLOSURE 

34 (UNDER 10 CFR 2.390) ........................................................................ D-1 

35 APPENDIX E GUIDANCE ON FINANCIAL ASSURANCE ......................................... E-1 

36 APPENDIX F MODEL TRAINING PROGRAM ............................................................. F-1 

37 APPENDIX G TYPICAL DUTIES AND RESPONSIBILITIES OF THE 

38 RADIATION SAFETY OFFICER ........................................................... G-1 

39 APPENDIX H MODEL DELEGATION OF AUTHORITY FOR RADIATION 

40 SAFETY OFFICER ................................................................................ H-1 

41 APPENDIX I J. L. SHEPHERD ORDER ....................................................................... I-1 

42 APPENDIX J SUGGESTED SELF-SHIELDED IRRADIATOR 

43 AUDIT CHECKLIST ............................................................................... J-1 

 
ix 

1 APPENDIX K RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND 

2 MODEL RADIATION SURVEY INSTRUMENT CALIBRATION 

3 PROGRAM ............................................................................................ K-1 

4 APPENDIX L GUIDANCE FOR DEMONSTRATING THAT UNMONITORED 

5 INDIVIDUALS ARE NOT LIKELY TO RECEIVE EXPOSURES 

6 EXCEEDING 10 PERCENT OF THE ALLOWABLE LIMITS ................ L-1 

7 APPENDIX M GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL 

8 MEMBERS OF THE PUBLIC WILL NOT RECEIVE DOSES 

9 EXCEEDING THE ALLOWABLE LIMITS ............................................. M-1 

10 APPENDIX N ADDITIONAL NOTIFICATIONS REQUIRED FOR 

11 SELF-SHIELDED IRRADIATOR LICENSEES ..................................... N-1 

12 APPENDIX O INFORMATION FOR APPLICANTS TO CONSIDER WHEN 

13 DEVELOPING OPERATING AND EMERGENCY PROCEDURES 

14 FOR SELF-SHIELDED IRRADIATORS ................................................ O-1 

15 APPENDIX P MODEL LEAK TEST PROGRAM ......................................................... P-1 

16 APPENDIX Q INFORMATION NEEDED TO SUPPORT APPLICANT’S 

17 REQUEST TO PERFORM NONROUTINE MAINTENANCE ................ Q-1 

18 APPENDIX R TRANSPORTATION ............................................................................. R-1 

19 APPENDIX S RADIATION SOURCE USE AND REPLACEMENT STUDY ................ S-1

xi 

1 FIGURES 

2 Figure Page 

3 1-1 Types of Irradiators. ....................................................................................................... 1-2 

4 2-1 U.S. Map: Locations of NRC Offices and Agreement States ......................................... 2-1 

5 8-1 Location of Use or Possession ....................................................................................... 8-4 

6 8-2 Typical Duties and Responsibilities of RSOs ............................................................... 8-11 

7 8-3 Material Receipt and Accountability. ............................................................................ 8-22 

8 8-4 Annual Dose Limits for Adult Radiation Workers ......................................................... 8-25 

9 8-5 Proper Location of Irradiator ........................................................................................ 8-28

10 8-6 Proper Handling of Incident. ......................................................................................... 8-31 

11 8-7 Routine Maintenance and Lubrication. ......................................................................... 8-36 

12 8-8 Nonroutine Maintenance. ............................................................................................. 8-37 

13 8-9 Illustrations for Import and Export. ............................................................................... 8-41

14 

15 M-1 Diagram of Office and Irradiator Area .......................................................................... M–2 

16 TABLES 

17 Table Page 

18 2-1 Who Regulates the Activity? .......................................................................................... 2-2

19 3-1 Traits of a Positive Safety Culture .................................................................................. 3-3

20 8-1 Minimum Inventory Quantity Requiring Financial Assurance ......................................... 8-7 

21 8-2 Record Maintenance .................................................................................................... 8-23 

22 B–1 Items 5 & 6: Materials to Be Possessed and Proposed Uses ...................................... B–1 

23 B–2 Items 7 Through 11: Training and Experience, Facilities and Equipment, 

24 Radiation Safety Program, and Waste Disposal ........................................................... B–6 

25 E–1 Worksheet for Determining Need for Financial Assurance for 

26 Self–Shielded Irradiators ............................................................................................... E–1 

27 L–1 Dosimetry Evaluation .................................................................................................... L–3 

28 M–1 Information Known About the Self Shielded Irradiator ................................................. M–3 

29 M–2 Calculation Method, Part 1: Hourly and Annual Dose Received from 

30 Self–Shielded Irradiator ................................................................................................ M–3 

31 M–3 Calculation Method, Part 2: Annual Dose Received from Self–Shielded Irradiator ..... M–4 

32 M–4 Calculation Method, Part 3: Summary of Information ................................................. M–5 

33 M–5 Calculation Method, Part 3: Annual Dose Received from Irradiator ............................ M–5 

34 M–6 Combination Measurement-Calculation Method .......................................................... M–7 

xiii 

1 ACKNOWLEDGMENTS 

2 The working group would like to thank the staff in the regional offices of the U.S. Nuclear 

3 Regulatory Commission and all of the Agreement States who provided comments and technical 

4 information that assisted in the development of this report. 

5 The working group also thanks Lisa Dimmick, Joseph Nick, John O’Donnell, Monica Ford, 

6 Tara Weidner, Tomas Herrera, and Duane White for developing the formatting and 

7 language used in many parts of the report. In addition, the Working Group thanks 

8 Celimar Valentin-Rodriguez for her creative graphic designs, editing assistance, and 

9 proof-reading skills. 

10 The Participants for this Revision

11 Hammann, Steve 

12 Katanic, Janine F. 

13 Moak, Jayson 

14 Modes, Kathy Dolce 

15 Roldán-Otero, Lizette 

16 Warren, Geoffrey 

xv 

1 ABBREVIATIONS 

2 ACMUI Advisory Committee on the Medical Uses of Isotopes 

3 ADAMS Agencywide Documents Access and Management System 

4 AEA Atomic Energy Act 

5 ALARA as low as is reasonably achievable 

6 ANSI American National Standards Institute 

7 AU authorized user 

8 bkg background 

9 Bq Becquerel 

10 C/kg coulomb per kilogram 

11 CFR Code of Federal Regulations

12 Ci curie 

13 Co-60 cobalt-60 

14 cpm counts per minute 

15 Cs-137 cesium-137 

16 d day 

17 DHS Department of Homeland Security 

18 DOE United States Department of Energy 

19 DOJ United States Department of Justice 

20 DOT United States Department of Transportation 

21 DVD digital versatile disc 

22 EPAct Energy Policy Act 

23 FR Federal Register

24 ft foot 

25 GM Geiger-Mueller 

26 GBq gigabecquerel 

27 GPO Government Printing Office 

28 GTRI Global Threat Reduction Initiative 

29 HPS Health Physics Society 

30 h hour 

31 IN Information Notice 

32 IP Inspection Procedure 

33 ISMP Integrated Source Management Portfolio 

34 kg kilogram 

35 L/C License Condition 

36 LVS License Verification System 

37 m meter 

38 MBq megabecquerel 

39 mCi millicurie 

40 MDA minimum detectable activity 

41 MeV million electron volts 

42 mo month 

43 MOU memorandum of understanding 

44 mR milliroentgen 

45 mrem millirem 

46 mSv millisievert 

47 NA National Academies 

48 NCRP National Council on Radiation Protection and Measurements 

49 NIST National Institute of Standards and Technology 

50 NMSS Office of Nuclear Material Safety and Safeguards 
xvi 

1 NNSA National Nuclear Security Administration 

2 NRC United States Nuclear Regulatory Commission 

3 NSTS National Source Tracking System 

4 NSTTR National Source Tracking Transaction Reports 

5 NVLAP National Voluntary Laboratory Accreditation Program 

6 OCFO Office of the Chief Financial Officer 

7 OCR optical character reader 

8 OEM original equipment manufacturer 

9 OMB Office of Management and Budget 

10 OSL optically stimulated luminescent 

11 PII Personally Identifiable Information 

12 Q quality factor 

13 QA quality assurance 

14 R roentgen 

15 rad radiaton-absorbed dose 

16 RED radiological exposure device 

17 Rem roentgen equivalent 

18 Rev. revision 

19 RDD radiological dispersal device 

20 R.G. Regulatory Guide 

21 RIS Regulatory Issue Summary 

22 RQ reportable quantities 

23 RSO radiation safety officer 

24 SA State Agreement 

25 SDE shallow-dose equivalent 

26 SI International System of Units (abbreviated “SI” from the French “le Système 

27 Internationale d’Unités”) 

28 Sr-90 strontium-90 

29 SSD sealed source and device 

30 std standard 

31 Sv sievert 

32 TAR technical assistance request 

33 TBq terabecquerel 

34 TEDE total effective dose equivalent 

35 TI transportation index 

36 TLD thermoluminescent dosimeters 

37 U.S.C. United States Code

38 U.S. United States 

39 URL Uniform Resource Locator 

40 wk week 

41 yr year 
1-1 

1 1 PURPOSE OF REPORT 

2 This report provides guidance to an applicant in preparing an application and applying for a 

3 self-shielded irradiator license and also provides the U.S. Nuclear Regulatory Commission 

4 (NRC) with criteria for evaluating such applications. This NUREG uses the terms “byproduct 

5 material,” “licensed material,” “staff,” and “radioactive material” interchangeably. Some 

6 licensees use an irradiator to calibrate instruments and dosimetry, and they use the word 

7 “calibrator” when referring to the irradiator. Within this NUREG, the terms “self-shielded 

8 irradiator,” “self-contained irradiator,” “calibrator,” and “irradiator” are used interchangeably. 

9 This report addresses the variety of radiation safety issues associated with self-shielded 

10 irradiators of different types. Self-shielded irradiators are of many different designs and may 

11 contain different sealed sources based, in part, on their intended use (e.g., for purposes in 

12 research, industry, medicine, and other fields). Typical uses include: 

13  irradiating blood or blood products 

14  sterilizing or reducing microbes in or on media, supplies, and products 

15  studying radiation effects on materials 

16  researching, synthesizing, and modifying chemicals and polymers 

17  eradicating insects through sterile male release programs 

18  conducting botanical and horticultural research 

19  conducting biomedical research, including the irradiation of small animals 

20  performing dosimetry applications, including calibration of dosimeters 

21  performing calibration of survey instruments 

22 Because of differences in design, manufacturers can provide appropriate instructions and 

23 recommendations for proper operation and maintenance. In addition, with irradiators of varying 

24 designs, the sealed sources may be oriented in different locations within the devices, resulting 

25 in different radiation safety challenges. Applicants should obtain this information from the 

26 manufacturers or suppliers if such information is not provided with the self-shielded irradiator. 

27 The American National Standards Institute (ANSI) has developed and published safety 

28 standards for gamma irradiators. In determining basic safety requirements, ANSI divided all 

29 gamma irradiators into four general categories. This NUREG deals with the type of irradiator 

30 discussed in ANSI/Health Physics Society (HPS) Standard N43.7-2007, “Safe Design and Use 

of Self-Contained, Dry Source Storage Gamma Irradiators (ANSI Category I).”1 31 This NUREG 

32 also uses the same definition of a self-shielded irradiator as the ANSI definition for a Category I 

33 irradiator: “[a]n irradiator in which the sealed source(s) is completely contained in a dry 

34 container constructed of solid materials, the sealed source(s) is shielded at all times, and 

35 human access to the sealed source(s) and the volume undergoing irradiation is not physically 

36 possible in its designed configuration.” 

 

1

Copies may be ordered electronically at the following URL: http://www.ansi.org or by writing to ANSI, 25 West 

43rd St., New York, NY 10036 (212-642-4900). Copies are also available from the Health Physics Society (HPS) at 

the following URL: http://www.hps.org or by writing to HPS, 1313 Dolley Madison Blvd., Suite 402, 

McLean, VA 22101 (703-790-1745). 
1-2 

1 This NUREG does not address the other three ANSI Categories of gamma irradiators that are 

2 regulated by the requirements of 10 CFR Part 36: (i) panoramic dry-source storage 

3 (ANSI Category II); (ii) self-contained wet-source storage (ANSI Category III); and 

4 (iii) panoramic wet-source storage (ANSI Category IV). These categories of irradiators are 

5 addressed in NUREG-1556 Volume 6, “Program Specific Guidance About 10 CFR Part 36 

6 Irradiator Licenses.” 

7 This NUREG does not address the manufacture, distribution, and service of self-shielded 

8 irradiators. The applicant for these types of activities may wish to refer to other NUREG-1556 

9 volumes, including: Volume 3, “Applications for Sealed Source and Device Evaluation and 

10 Registration;” Volume 12, “Program-Specific Guidance About Possession Licenses for 

11 Manufacturing and Distribution;” and Volume 18, “Program-Specific Guidance About Service 

12 Provider Licenses.” 

13 For the self-shielded irradiators covered by this NUREG, the radionuclides most commonly used 

14 are cesium-137 and cobalt-60. On July 25, 2011, the NRC issued a statement of policy on the 

15 protection of cesium-137 chloride sources, such as those typically used in self-shielded 

16 irradiators. The statement sets forth the NRC’s policy regarding secure uses of these sources 

17 and provides the NRC’s expectations for the security and safety of these sources. The full text 

18 of the policy statement can be found in the Federal Register (76 FR 44378) on July 25, 2011, 

19 and can be found at http://www.gpo.gov/fdsys/pkg/FR-2011-07-25/pdf/2011-18767.pdf. 

20 Depending on the design, the radiation source within the irradiator may be in a fixed position or 

21 may be movable within the unit. In the latter case, interlocks are used to ensure that the source 

22 does not move into a position that, during normal use of the irradiators, may cause a radiation 

23 hazard to any individual. Bypassing or failure of an interlock could cause persons to be 

24 exposed to high levels of radiation. 

25 Applicants can request that an existing NRC license be amended to authorize the possession 

26 and use of a self-shielded irradiator or can request that a separate license be issued to 

27 authorize the possession and use of a self-shielded irradiator. 

Figure 1-1. Types of Irradiators. The Irradiator on the Far Left is Used to Calibrate 

Dosimetry Devices, While the Center Unit Can be Used to Sterilize Blood, 

and the Unit on the Right is Typically Used for Research. 

Examples of Self-Shielded Irradiators

62-ppt7-9128-101b

060997
1-3 

1 Chapter 8 of this NUREG, “Contents of an Application,” identifies the information needed to 

2 complete NRC Form 313, “Application for Materials License” (see Appendix A of this NUREG), 

3 for the use of sealed sources containing byproduct material in self-shielded irradiators. The 

4 Office of Management and Budget (OMB) has approved the information collection requirements 

5 in Title 10 of the Code of Federal Regulations (10 CFR) Part 30, “Rules of General Applicability 

6 to Domestic Licensing of Byproduct Material,” and NRC Form 313 under OMB Clearance 

7 Nos. 3150-0017 and 3150-0120, respectively. 

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

9  Regulations—references the regulations applicable to the item. 

10  Criteria—outlines the criteria used to evaluate the applicant’s response. 

11  Discussion—provides additional information about the topic. 

12  Response from Applicant—provides suggested response or responses, offers the option 

13 of an alternative reply, or indicates that no response is needed on that topic during the 

14 licensing process. 

15 Notes and references are self-explanatory and may not be found for each item on 

16 NRC Form 313. 

17 NRC Form 313 does not have sufficient space for applicants to provide full responses to 

18 Items 5 through 11, as indicated on the form. Applicants should address those items on 

19 separate sheets of paper and submit them along with the completed NRC Form 313. For 

20 the convenience and streamlined handling of self-shielded irradiator applications, Appendix B of 

21 this NUREG, “Suggested Format for Providing Information Requested in Items 5 

22 through 11 of NRC Form 313,” may be used to provide supporting information. 

23 In this NUREG, “dose” or “radiation dose” means absorbed dose, dose equivalent, effective 

24 dose equivalent, committed dose equivalent, committed effective dose equivalent, or total 

25 effective dose equivalent (TEDE), as defined in 10 CFR Part 20, “Standards for Protection 

26 Against Radiation.” To describe units of radiation exposure or dose, rem and its International 

27 System of Units equivalent, sievert (Sv) (1 rem = 0.01 Sv), are used. This is used because 

28 10 CFR Part 20 sets dose limits in terms of rem (Sv), rather than rad or roentgen. When the 

29 radioactive material emits beta and gamma rays, 1 roentgen is assumed to equal 1 rad, which is 

30 assumed to equal 1 rem. For alpha and neutron-emitting radioactive material, 1 rad is not equal 

31 to 1 rem. Determination of dose equivalent (rem) from absorbed dose (rad) from alpha particles 

32 and neutrons requires the use of an appropriate quality factor (Q) value. These Q values are 

33 used to convert absorbed dose (rad) to dose equivalent (rem). Tables 1004(b).1 and .2 in 

34 10 CFR 20.1004, “Units of radiation dose,” address the Q values for alpha particles and 

35 neutrons. 

2-1 

1 2 AGREEMENT STATES 

2 2.1 Jurisdiction Determination 

3 Certain States, called Agreement States (see Figure 2-1), have entered into agreements with 

4 the U.S. Nuclear Regulatory Commission (NRC) that give them the authority to license and 

5 inspect byproduct, source, and special nuclear materials in quantities not sufficient to form a 

6 critical mass, which are used or possessed within their borders. Any applicant, other than a 

7 Federal entity, who wishes to possess or use licensed material in one of these Agreement 

8 States should contact the responsible officials in that State for guidance on preparing an 

9 application. These applications should be filed with State officials, not with the NRC. In areas 

10 under exclusive Federal jurisdiction within an Agreement State, NRC continues to be the 

11 regulatory authority. 

Figure 2-1. U.S. Map: Locations of NRC Offices and Agreement States

12 In the special situation of work at federally controlled sites in Agreement States, it is necessary 

13 to ascertain the jurisdictional status of the area to determine whether the NRC or the Agreement 

1

1
2-2 

1 State has regulatory authority. These areas can also include Tribal lands of federally 

recognized Indian Tribes2 2 . 

3 The NRC has regulatory authority over land determined to be “exclusive Federal jurisdiction,” 

4 while the Agreement State may have jurisdiction over nonexclusive Federal jurisdiction land. 

5 Applicants are responsible for determining, in advance, the jurisdictional status of the specific 

6 areas where they plan to conduct licensed operations. Additional guidance on determining 

7 jurisdictional status is found in the Office of Nuclear Material Safety and Safeguards (NMSS) 

8 procedures in the State Agreement series, SA-500, “Jurisdiction Determination,” which is 

9 available at https://scp.nrc.gov. Once on the Web site, use the link for “NMSS Procedures” in 

10 the left-hand column under “Resources & Tools.” 

11 Table 2-1 provides a quick way to evaluate whether the NRC or an Agreement State has 

12 regulatory authority. 

Table 2-1. Who Regulates the Activity? 

Applicant and Proposed Location of Work Regulatory Agency 

Federal agency, regardless of location (except that the 

U.S. Department of Energy and, under most circumstances, its prime 

contractors are exempt from licensing, in accordance with Title 10 of 

the Code of Federal Regulations (CFR) 10 CFR 30.12, “Persons 

using byproduct material under certain Department of Energy and 

Nuclear Regulatory Commission contracts”) 

NRC 

Non-Federal entity in non-Agreement State, District of Columbia, 

U.S. territory or possession, or in offshore Federal waters NRC 

Federally recognized Indian Tribe or Tribal member on Indian Tribal 

land NRC 

Non-Federal entity on federally recognized Indian Tribal land NRC3

Federally recognized Indian Tribe or Tribal member outside of Indian 

Tribal land in Agreement State Agreement State 

 

2

For the purposes of this guidance, an “Indian Tribe” is defined as an Indian or Alaska Native tribe, band, nation, 

pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian Tribe pursuant to 

the Federally Recognized Indian Tribe List Act of 1994. A list of federally recognized tribes is available at 

www.bia.gov. 

3

The NRC can exercise jurisdiction as the regulatory authority on Tribal land of a federally recognized Indian Tribe. 

Section 274b. agreements do not give States the authority to regulate nuclear material in these areas. However, 

there may be States that exercise regulatory authority over these areas based on treaties or agreements with specific 

tribes. Companies owned or operated by federally recognized Indian Tribe members or non-Indians that wish to 

possess or use licensed material on Tribal lands should contact the appropriate NRC regional office to determine the 

jurisdictional status of the Tribal lands and identify the appropriate regulatory agency for licensing and reciprocity. 
2-3 

Table 2-1. Who Regulates the Activity? 

Applicant and Proposed Location of Work Regulatory Agency 

Non-Federal entity in Agreement State Agreement State4

Non-Federal entity in Agreement State at federally controlled site not

subject to exclusive Federal jurisdiction Agreement State4

Non-Federal entity in Agreement State at federally controlled site 

subject to exclusive Federal jurisdiction NRC 

Non-Federal entity in Agreement State using radioactive materials 

(except industrial radiography) directly connected with 10 CFR Part 

50 or 52 reactor operations or needed during the construction and 

preoperational phases of a reactor. 

NRC 

Non-Federal entity in Agreement State using radioactive materials 

not directly connected with 10 CFR Part 50 or 52 reactor operations 

or needed during the construction and preoperational phases of 

a reactor. 

Agreement State4

1 Reference: A current list of Agreement States (including names, addresses, and telephone 

2 numbers of responsible officials) is available at the NMSS public Web site at https://scp.nrc.gov. 

3 A request for the list can also be made to an NRC regional office. 

4 2.2 Reciprocal Recognition of Specific Licenses 

5 Performing licensed activities in other jurisdictions is possible through reciprocal recognition of 

6 specific licenses (i.e., reciprocity). Agreement States have reciprocity provisions that permit 

7 NRC licensees to perform licensed activities under circumstances when an Agreement State is 

8 the regulatory authority (See Section 2.1). NRC licensees and Agreement State licensees are 

9 subject to the regulations of the regulatory authority as indicated in Section 2.1. To ensure 

10 compliance with an Agreement State’s reciprocity requirements, licensees are advised to 

11 request authorization from the appropriate Agreement State radiation control program office well 

12 in advance of the scheduled use of licensed material. 

13 Agreement State licensees that wish to conduct licensed activities in areas under NRC 

14 jurisdiction must either obtain a specific NRC license or file for reciprocity with the appropriate 

15 NRC regional office for the Agreement State that issued their license. Failure to file for 

16 reciprocity or obtain a specific NRC license before working in areas under NRC jurisdiction can 

 

4

Section 274m. of the Atomic Energy Act (AEA) withholds to the NRC regulatory authority over radioactive materials 

covered under the Section 274b. agreements when the activity can affect the Commission’s authority to protect the 

common defense and security, to protect restricted data, or guard against the loss or diversion of special nuclear 

material. (This is an uncommon situation that NRC usually evaluates on a case-by-case basis.) Individuals or 

companies wishing to possess or use licensed material should contact the licensee to determine the jurisdictional 

status for specific AEA radioactive materials they intend to possess or use. 
2-4 

1 result in NRC enforcement action, which may include civil penalties. The reciprocity filing must 

2 be renewed annually. 

3 Specific guidance regarding NRC licensees filing for reciprocity in Agreement States and 

4 Agreement State licensees filing for reciprocity with the NRC or another Agreement State are 

5 provided in NUREG–1556, Volume 19, “Consolidated Guidance About Materials 

6 Licenses: Guidance for Agreement State Licensees About NRC Form 241 ‘Report of Proposed 

7 Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, or Offshore Waters’ 

8 and Guidance for NRC Licensees Proposing to Work in Agreement State Jurisdiction 

9 (Reciprocity).” 
3-1 

1 3 MANAGEMENT RESPONSIBILITY 

2 The U.S. Nuclear Regulatory Commission (NRC) recognizes that effective management of 

3 radiation safety programs is vital to achieving safe, secure, and compliant operations. 

4 Consistent compliance with NRC regulations provides reasonable assurance that licensed 

5 activities will be conducted safely and that effective management will result in increased safety, 

6 security, and compliance. 

“Management,” as used in this volume, refers to the processes for conduct and control of a 

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. 

7 3.1 Commitments and Responsibilities 

8 Pursuant to Title 10 of the Code of Federal Regulations [CFR 30.32(c)], each application must 

9 be signed by the applicant or licensee or a person duly authorized to act for and on behalf of the 

10 applicant or licensee. If it is not clear whether the application was signed by someone duly 

11 authorized to act for and on the behalf of the applicant or licensee, NRC license reviewers may 

12 ask for additional assurances that the individual that signed the application is duly authorized to 

13 act for and on the behalf of the applicant or licensee. The signature on an application 

14 acknowledges the licensee’s commitments and responsibilities for the following: 

15  radiation safety, security, and control of radioactive materials and compliance 

16 with regulations 

17  completeness and accuracy of the radiation safety records and all information provided 

18 to the NRC (10 CFR 30.9, “Completeness and accuracy of information”) 

19  knowledge about the contents of the license and application 

20  compliance with current NRC and U.S. Department of Transportation (DOT) 

21 regulations; the licensee’s operating, emergency, and security procedures; and NRC 

22 license commitments 

23  commitment to provide adequate resources (including space, equipment, personnel, 

24 time, and, if needed, contractors) to the radiation protection program to ensure that the 

25 public and workers are protected from radiation hazards and compliance with regulations 

26 is maintained 

27  commitment to report defects, noncompliances, or reportable events in accordance with 

28 regulations 

29  selection and assignment of a qualified individual to serve as the radiation safety officer 

30 (RSO) for licensed activities and confirmation that the RSO has independent authority to 

31 stop unsafe operations and will be given sufficient time to fulfill radiation safety duties 

32 and responsibilities 

33  commitment to ensure that radiation workers have adequate training 
3-2 

1  prevention of discrimination of employees engaged in protected activities (10 CFR 30.7, 

2 “Employee protection”) 

3  commitment to provide information to employees about the employee protection and 

4 deliberate misconduct provisions in 10 CFR 30.7, “Employee protection” and 

5 10 CFR 30.10, “Deliberate misconduct” 

6  commitment to obtain the NRC’s prior written consent before transferring control of the 

7 license (see Section 9.1, “Timely Notification of Transfer of Control,” of this NUREG) 

8  notification of the appropriate NRC regional administrator, in writing, immediately 

9 following the filing of a petition for voluntary or involuntary bankruptcy [10 CFR 30.34(h)], 

10 as discussed further in Section 8.2.1, “Notification of Bankruptcy Proceedings,” of 

11 this NUREG. 

12 For information on NRC inspection, investigation, enforcement, and other compliance programs, 

13 see the current version of the NRC’s Enforcement Policy and Inspection Manual available in the 

14 NRC’s online library, under “Document Collections,” at http://www.nrc.gov/reading-rm.html. 

15 3.2 Safety Culture 

16 Individuals and organizations performing regulated activities are expected to establish and 

17 maintain a positive safety culture commensurate with the safety and security significance of 

18 their activities and the nature and complexity of their organizations and functions. This applies 

19 to all licensees, certificate holders, permit holders, authorization holders, holders of quality 

20 assurance program approvals, vendors and suppliers of safety-related components, and 

21 applicants for a license, certificate, permit, authorization, or quality assurance program approval, 

22 subject to NRC authority. 

23 “Nuclear safety culture” is defined in the NRC’s safety culture policy statement (76 FR 34773; 

24 June 14, 2011) as ”the core values and behaviors resulting from a collective commitment by 

25 leaders and individuals to emphasize safety over competing goals to ensure protection of 

26 people and the environment.” Individuals and organizations performing regulated activities bear 

27 the primary responsibility for safely handling and securing these materials. Experience has 

28 shown that certain personal and organizational traits are present in a positive safety culture. A 

29 trait, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, 

30 particularly in goal conflict situations (e.g., production versus safety, schedule versus safety, 

31 and cost of the effort versus safety). Refer to Table 3-1 for the traits of a positive safety culture 

32 from NRC’s safety culture policy statement. 

33 Organizations should ensure that personnel in the safety and security sectors have an 

34 appreciation for the importance of each, emphasizing the need for integration and balance to 

35 achieve both safety and security in their activities. Safety and security activities are closely 

36 intertwined. While many safety and security activities complement each other, there may be 

37 instances in which safety and security interests create competing goals. It is important that 

38 consideration of these activities be integrated so as not to diminish or adversely affect either; 

39 thus, mechanisms should be established to identify and resolve these differences. A safety 

40 culture that accomplishes this would include all nuclear safety and security issues associated 

41 with NRC-regulated activities. 
3-3 

Table 3-1. Traits of a Positive Safety Culture 

Leadership Safety Values 

and Actions

Problem Identification 

and Resolution Personal Accountability

Leaders demonstrate a 

commitment to safety in their 

decisions and behaviors. 

Issues potentially impacting 

safety are promptly 

identified, fully evaluated, 

and promptly addressed and 

corrected commensurate 

with their significance. 

All individuals take personal 

responsibility for safety. 

Work Processes Continuous Learning

Environment for Raising 

Concerns

The process of planning and 

controlling work activities is 

implemented so that safety 

is maintained. 

Opportunities to learn about 

ways to ensure safety are 

sought out and implemented. 

A safety conscious work 

environment is maintained 

where personnel feel free to 

raise safety concerns without 

fear of retaliation, 

intimidation, harassment, or 

discrimination. 

Effective Safety 

Communications

Respectful Work 

Environment Questioning Attitude

Communications maintain a 

focus on safety. 

Trust and respect permeate 

the organization. 

Individuals avoid 

complacency and 

continuously challenge 

existing conditions and 

activities in order to identify 

discrepancies that might 

result in error or 

inappropriate action. 

1 The NRC, as the regulatory agency with an independent oversight role, reviews the 

2 performance of individuals and organizations to determine compliance with requirements and 

3 commitments through its existing inspection and assessment processes. However, NRC’s 

4 safety culture policy statement and traits are not incorporated into the regulations. Safety 

5 culture traits may be inherent to an organization’s existing radiation safety practices and 

6 programs. For instance, if an irradiator operator notices that an irradiator chamber door is not 

7 properly latching, the operator should immediately cease using the irradiator and inform 

8 management so that the Radiation Safety Officer (RSO) is notified. The RSO should call the 

9 manufacturer, distributor, or service provider for repair and alert all irradiator operators not to 

10 use the irradiator until the door latch is fixed. If the door latch completely fails, so that the door 

11 can be opened with the source in the unshielded position, the licensee is required to notify the 

12 NRC Headquarters Operations Center within 24 hours of discovery of an event involving 

13 licensed material in which equipment is disabled or fails to function when it is required to be 

14 available and operable to prevent exposures exceeding regulatory limits. The need to 

15 recognize an equipment failure and make a 24-hour report may correspond with the safety 
3-4 

1 culture trait specified in Table 3-1 “Problem Identification and Resolution” (issues potentially 

2 impacting safety are promptly identified, fully evaluated, and promptly addressed and corrected 

3 commensurate with their significance). 

4 However, licensees should be aware that this is just an example, and should consider reviewing 

5 their radiation safety programs in order to develop and implement a safety culture program 

6 commensurate with the nature and complexity of their organizations and functions. 

7 Refer to Appendix C of this NUREG for the NRC’s safety culture policy statement. More 

8 information on NRC activities relating to safety culture can be found at 

9 http://www.nrc.gov/about-nrc/safety-culture.html. 
4-1 

1 4 APPLICABLE REGULATIONS 

2 It is the applicant’s or licensee’s responsibility to obtain and have available up-to-date copies of 

3 applicable regulations, to read and understand the requirements of each of these regulations, 

4 and to comply with each applicable regulation. The following parts of Title 10 of the Code of 

5 Federal Regulations (CFR) contain regulations applicable to self-shielded irradiators. Some of 

6 these parts are specific to one type of license, while others are general and will apply to many, if 

7 not all, licensees. 

8 The current versions of these 10 CFR regulations can be found under the “Basic References” 

9 link at the U.S. Nuclear Regulatory Commission’s (NRC’s) online library at 

10 http://www.nrc.gov/reading-rm.html; for viewing in a browser, the following list includes direct 

11 links to the rules: 

12  10 CFR Part 2 “Agency Rules of Practice and Procedure” 

13  10 CFR Part 19 “Notices, Instructions and Reports to Workers: Inspection 

14 and Investigations” 

15  10 CFR Part 20 “Standards for Protection Against Radiation” 

16  10 CFR Part 21 “Reporting of Defects and Noncompliance” 

17  10 CFR Part 30 “Rules of General Applicability to Domestic Licensing of 

18 Byproduct Material” 

19  10 CFR Part 32 “Specific Domestic Licenses to Manufacture or Transfer Certain 

20 Items Containing Byproduct Material” 

21  10 CFR Part 33 “Specific Domestic Licenses of Broad Scope for 

22 Byproduct Material” 

23  10 CFR Part 36 “Licenses and Radiation Safety Requirements for Irradiators” 

24  10 CFR Part 37 “Physical Protection of Category 1 and Category 2 Quantities of 

25 Radioactive Material” 

26  10 CFR Part 71 “Packaging and Transportation of Radioactive Material” 

27  10 CFR Part 110 “Export and Import of Nuclear Equipment and Material” 

28  10 CFR Part 150 “Exemptions and Continued Regulatory Authority in Agreement 

29 States and in Offshore Waters under Section 274” 

30  10 CFR Part 170 “Fees for Facilities, Materials, Import and Export Licenses, and 

31 Other Regulatory Services under the Atomic Energy Act of 1954, 

32 as Amended” 
4-2 

1  10 CFR Part 171 “Annual Fees for Reactor Licenses and Fuel Cycle Licenses and 

2 Materials Licenses, Including Holders of Certificates of 

3 Compliance, Registrations, and Quality Assurance Program 

4 Approvals and Government Agencies Licensed by the NRC” 

5 Copies of the above documents may be obtained by calling the Government Publishing Office 

6 Customer Contact Center toll-free at 866-512-1800, in Washington, DC, at 202-512-1800, or 

7 online at http://bookstore.gpo.gov. In addition, 10 CFR Parts 1 through 199 can be found on the 

8 NRC’s Web site at http://www.nrc.gov/reading-rm/doc-collections/ under “Regulations 

9 (10 CFR).” 

10 NRC regulations can also be accessed from the “NRC Library” link on the NRC’s public Web 

11 site at http://www.nrc.gov. Regulations are periodically amended, and the NRC (as well as 

12 all other Federal agencies) is required to publish notice of such amendments in the 

13 Federal Register. 
5-1 

1 5 HOW TO FILE 

2 5.1 Application Preparation 

3 Applicants for a materials license should do the following: 

4  Use the most recent guidance in preparing an application. 

5  Complete U.S. Nuclear Regulatory Commission (NRC) Form 313 (Appendix A of this 

6 NUREG), Items 1 through 4, 12, and 13, on the form itself. A link to the form is available 

7 at http://www.nrc.gov/reading-rm/doc-collections/forms/. 

8  Complete NRC Form 313, Items 5 through 11, on supplementary pages or use 

9 Appendix B of this NUREG. 

10  Provide sufficient detail for the NRC to determine that the equipment, facilities, training, 

11 experience, and radiation safety program are adequate to protect health and safety and 

12 minimize danger to life and property. 

13  For each separate sheet other than NRC Form 313 and Appendix B pages, as 

14 applicable, identify and cross-reference submitted information to the item number on the 

15 application or the topic to which it refers. 

16  Avoid submitting proprietary information and personally identifiable information. If 

17 submitted, proprietary, personal privacy, security-related, and other sensitive information 

18 should be clearly identified according to Title 10 of the Code of Federal Regulations

19 (CFR) Part 2.390, “Public inspections, exemptions, requests for withholding” 

20 (see Chapter 6, “Identifying and Protecting Sensitive Information”). 

21 5.2 Where to File 

22 Applicants wishing to possess or use licensed material in any State, U.S. territory, or 

23 U.S. possession subject to NRC jurisdiction must file an application with the NRC regional office 

24 for the locale in which the material will be possessed or used. Figure 2-1 identifies the NRC’s 

25 four regional offices and their respective areas for licensing purposes and the Agreement 

26 States. Note that all materials applications are submitted to Regions I, III, or IV. All applicants 

27 for materials licenses located in the Region II geographical area should send their applications 

28 to Region I. 

29 In general, applicants wishing to possess or use licensed material in Agreement States must file 

30 an application with the Agreement State and not with the NRC. However, if work will be 

31 conducted at federally controlled sites, or federally recognized Indian Tribal lands in Agreement 

32 States, applicants must first determine the jurisdictional status of the land in order to determine 

33 whether the NRC or the Agreement State has regulatory authority. See Chapter 2, “Agreement 

34 States,” for additional information. 
5-2 

1 5.3 Paper Applications 

2 Paper applications received by the NRC are scanned through an optical character reader and 

3 converted to an electronic format. To ensure a smooth transfer to an electronic format, 

4 applicants should do the following: 

5  Submit all documents, typed, on 81⁄2 × 11-inch or legal-sized paper that will feed easily 

6 into a document scanner. 

7  Choose typeface designs that are sans serif, such as Arial, Helvetica, or Futura. 

8  Use 11-point or larger font. 

9  Avoid stylized characters, such as script or italics. 

10  Ensure that the print is clear and sharp. 

11  Ensure that there is high contrast between the ink and paper (black ink on white paper 

12 is best). 

Applications must be signed by the applicant, licensee, or a person duly authorized as 

required by 10 CFR 30.32(c) (see Section 8.13, “Certification”). 

13 5.4 Electronic Applications 

14 Applications may be submitted in electronic form via the NRC’s Electronic Information Exchange 

15 or CD-ROM. Detailed guidance on making electronic submissions can be obtained by visiting 

16 the NRC’s Web site at http://www.nrc.gov/site-help/e-submittals.html. The guidance discusses, 

17 among other topics, the formats the NRC can accept, the use of electronic signatures, and the 

18 treatment of non-public information.
6-1 

1 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION 

2 All licensing applications, except for portions containing sensitive information, will be made 

3 available for review in the U.S. Nuclear Regulatory Commission (NRC) Public Document Room 

4 and electronically at the NRC Library. For more information on the NRC Library, visit 

5 www.nrc.gov. 

6 The applicant or licensee should identify, mark, and protect sensitive information against 

7 unauthorized disclosure to the public. License applications that contain sensitive information 

8 should be marked, as indicated in the list that follows, in accordance with Title 10 of the Code of 

9 Federal Regulations (CFR) 10 CFR 2.390 before the information is submitted to the NRC. Key 

10 examples are as follows: 

11  Proprietary Information and Trade Secrets: If it is necessary to submit proprietary 

12 information or trade secrets, follow the procedure in 10 CFR 2.390(b). Failure to follow 

13 this procedure could result in disclosure of the proprietary information to the public or 

14 substantial delays in processing the application. Appendix D of this NUREG provides a 

15 checklist for requests for withholding proprietary information from public disclosure. 

16  Personally Identifiable Information: Personally identifiable information (PII) about 

17 employees or other individuals should not be submitted unless specifically requested by 

18 the NRC. Examples of PII are social security number, home address, home telephone 

19 number, date of birth, and radiation dose information. If PII is submitted, a cover letter 

20 should clearly state that the attached documents contain PII, and the top of every page 

21 of a document that contains PII should be clearly marked as follows: “Privacy Act 

22 Information—Withhold Under 10 CFR 2.390.” For further information, see Regulatory 

23 Issue Summary (RIS) 2007-04, “Personally Identifiable Information Submitted to the 

24 U.S. Nuclear Regulatory Commission,” dated March 9, 2007, and Information Notice (IN) 

25 2013-22, “Recent Licensing Submittals Containing Personally Identifiable Information,” 

26 dated November 15, 2013, which can be found on the NRC’s Generic Communications 

27 Web page under “Regulatory Issue Summaries” and “Information Notices,” respectively, 

28 at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/. 

29  Security-Related Information: Following the events of September 11, 2001, the NRC 

30 changed its procedures to avoid the release of information that terrorists could use to 

31 plan or execute an attack against facilities or citizens in the U.S. As a result, certain 

32 types of information are no longer routinely released and are treated as sensitive 

33 unclassified information. For example, certain information about the quantities and 

34 locations of radioactive material at licensed facilities, and associated security measures 

35 are no longer released to the public. Therefore, a cover letter should clearly state that 

36 the attached documents contain sensitive security-related information and the top of 

37 every page of a document that contains such information should be clearly marked: 

38 “Security Related Information—Withhold Under 10 CFR 2.390.” For the pages having 

39 security-related sensitive information, an additional marking should be included (e.g., an 

40 editorial note box) adjacent to that material. For further information, see RIS 2005-31, 

41 “Control of Security-Related Sensitive Unclassified Non-Safeguards Information Handled 

42 by Individuals, Firms, and Entities Subject to NRC Regulation of the Use of Source, 

43 Byproduct, and Special Nuclear Material,” dated December 22, 2005, which can be 

44 found on the NRC’s Generic Communications Web page under “Regulatory Issue 

45 Summaries” at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/. Additional 
6-2 

1 information on procedures and any updates is available at http://www.nrc.gov/reading2 rm/sensitive-info.html. 

3 The regulations list various forms of information that can be protected from public disclosure. 

4 These include: 

5  trade secrets and commercial or financial information 

6  interagency or intra-agency memoranda or letters that would not be available by law to a 

7 party other than an agency in litigation with NRC 

8  certain records or information compiled for law enforcement purposes 

9  geological and geophysical information and data, including maps, or information 

10 concerning wells 

11  personnel, medical, and other information, the disclosure of which would constitute a 

12 clearly unwarranted invasion of personal privacy 

13 In 10 CFR 2.390, NRC specifies the procedures and requirements for persons to submit 

14 sensitive information to NRC so that it may be properly protected from disclosure. This 

15 regulation is available electronically on the NRC Web site at http://www.nrc.gov/reading-rm/doc16 collections/cfr. 

17 Except for personal privacy information, which is not subject to the affidavit requirement, if NRC 

18 determines that the application or affidavit is deficient (i.e., does not contain the required 

19 information as outlined in 10 CFR 2.390), the applicant will be notified that additional information 

20 is needed and that the review will continue when the required information is received. 

21 If the request is denied, in whole or in part, NRC will give the applicant the option of withdrawing 

22 the information or application, as permitted in 10 CFR 2.390. If the applicant decides not to 

23 withdraw the information or application, NRC will notify the applicant, in writing, that the request 

24 for withholding has been denied and that NRC will disregard any references concerning the 

25 proprietary status of the information. 

26 Any part of a license application or information provided by a licensee or applicant that the NRC 

27 determines should be withheld from public disclosure will be handled in accordance with 

28 Management Directive 12.6, “NRC Sensitive Unclassified Information Security Program,” and 

29 the licensee or applicant will be notified in writing that NRC plans to honor the request. 

30 Management Directive 12.6 is available electronically on the NRC Web site at 

31 http://www.nrc.gov/reading-rm/doc-collections/management-directives/. 
6-3 

Anyone submitting a request to withhold information from public disclosure should thoroughly 

review 10 CFR 2.390 and be familiar with its requirements and limitations. 

Withholding from public inspection will not affect the right, if any, of persons properly and 

directly concerned to inspect the documents. If the need arises, NRC may send copies of this 

information to NRC consultants working in that area. NRC will ensure that the consultants 

have signed the appropriate agreements for handling proprietary information. 

If the basis for withholding this information from public inspection should change in the future, 

such that the information could then be made available for public inspection, the licensee or 

applicant should promptly notify the NRC. The licensee or applicant also should understand 

that NRC may have cause to review this determination in the future (e.g., if the scope of a 

Freedom of Information Act request includes the information in question). In all review 

situations, if NRC makes a determination adverse to the above, the licensee or applicant will 

be notified in advance of any public disclosure. Anyone submitting commercial or financial 

information they believe to be privileged, confidential, or a trade secret must remember that 

the NRC’s policy is to achieve an effective balance between legitimate concerns for the 

protection of competitive positions and the right of the public to be fully apprised of the basis 

for, and the effects of, licensing or rulemaking actions. It is within NRC’s discretion to withhold 

such information from public disclosure. 

7-1 

1 7 APPLICATION AND LICENSE FEES 

2 Each application for which a fee is specified must be accompanied by the appropriate fee. 

3 Refer to Title 10 of the Code of Federal Regulations (CFR) 170.31, “Schedule of fees for 

4 materials licenses and other regulatory services, including inspections, and import and export 

5 licenses,” to determine the amount of the fee. The U.S. Nuclear Regulatory Commission (NRC) 

6 will not issue a license until the fee is received. Consult 10 CFR 170.11, “Exemptions,” for 

7 information on exemptions from these fees. Once the technical review of an application has 

8 begun, no fees will be refunded. Application fees will be charged regardless of the NRC’s 

9 disposition of an application or the withdrawal of an application. 

10 Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16, “Annual fees: 

11 Materials licensees, holders of certificates of compliance, holders of sealed source and device 

12 registrations, holders of quality assurance program approvals, and government agencies 

13 licensed by the NRC.” Consult 10 CFR 171.11 for information on exemptions from annual fees 

14 and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as “small entities.” 

15 Note that in order to pay reduced fees, a licensee that qualifies as a “small entity” must provide 

16 proper certification of this status to the NRC each year, along with its annual fee payment. 

17 Direct all questions about the NRC’s fees or completion of Item 12 of NRC Form 313 to the 

18 Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, 

19 301-415-7554. Information about fees may also be obtained by calling NRC’s toll-free number, 

20 800-368-5642, extension 415-7554. The e-mail address is Fees.Resource@nrc.gov. 

8-1 

1 8 CONTENTS OF AN APPLICATION 

2 The following information applies to the indicated items on NRC Form 313 (Appendix A of this 

3 NUREG). 

4 All items in the application should be completed in enough detail for the NRC to determine 

5 whether the proposed equipment, facilities, training and experience, and radiation safety and 

6 security programs satisfy regulatory requirements and are adequate to protect public health and 

7 safety and minimize danger to life and property. Consideration should be given, when 

8 developing the application, to the concepts of keeping exposure as low as is reasonably 

9 achievable (ALARA), minimizing contamination, and maintaining control of radioactive materials. 

10 Title 10 of the Code of Federal Register (10 CFR) 20.1101(b) states: “The licensee shall use, to 

11 the extent practical, procedures and engineering controls based upon sound radiation protection 

12 principles to achieve occupational doses and doses to members of the public that are ALARA.” 

13 Regulatory Guide 8.10, Rev. 2, “Operating Philosophy for Maintaining Occupational Radiation 

14 Exposures as Low as Is Reasonably Achievable,” discusses the ALARA concepts and 

15 philosophy. The application should document ALARA considerations, including establishing 

16 administrative action levels and monitoring programs. 

17 10 CFR 20.1406, “Minimization of contamination,” requires applicants for licenses to describe 

18 how facility design and procedures for operation will minimize, to the extent practicable, 

19 contamination of the facility and the environment; facilitate eventual decommissioning; and 

20 minimize, to the extent practicable, the generation of radioactive waste. As with ALARA 

21 considerations, applicants should address these concerns for all aspects of their programs. 

22 The application should include information on how the licensee will implement the security 

23 requirements in 10 CFR 20.1801, “Security of stored material,” 10 CFR 20.1802, “Control of 

24 material not in storage,” and 10 CFR Part 37 “Physical Protection of Category 1 and Category 2 

25 Quantities of Radioactive Material.” 

26 The majority of self-shielded irradiator licensing actions will fall under the categorical exclusion 

27 in 10 CFR 51.22(c)(14)(vii). This means that the licensing action will not require an 

28 environmental assessment or environmental impact statement in accordance with 

29 10 CFR 51.22(b), because the NRC has already determined that this type of licensing action 

30 does not have a significant impact on the environment. 

31 All information submitted to the NRC during the licensing process may be incorporated as part 

32 of the license and will be subject to review during inspection. 

33 8.1 Item 1: License Action Type 

34 Item 1 of NRC Form 313 states the following: 

35 This is an application for (check appropriate item): 

Type of Action License No.

[ ] A. New License Not Applicable 

[ ] B. Amendment XX-XXXXX-XX 

[ ] C. Renewal XX-XXXXX-XX 
8-2 

1 Check Box A for a new license request. Note that a prelicensing visit may be required prior to 

2 issuance of the license. 

3 Check Box B for an amendment to an existing license, and provide the license number. 

4 Check Box C for the renewal of an existing license, and provide the license number. 

5 See “License Amendments and Renewals” in Chapter 9 of this report. 

6 8.2 Item 2: Name and Mailing Address of Applicant 

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

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

9 An individual may be designated as the applicant only if the individual is acting in a private 

10 capacity and the use of the radioactive material is not connected with employment in a 

11 corporation or other legal entity. Provide the mailing address where correspondence should be 

12 sent. A post office box number is an acceptable mailing address. 

13 Notify the NRC of changes in the mailing address. These changes do not require a fee. 

14 Note: The NRC must be notified and the transfer approved before control of the license is 

15 transferred (see Section 9.1, “Timely Notification of Transfer of Control”). The NRC must also 

16 be notified when bankruptcy proceedings have been initiated (see Section 8.2.1, “Notifications 

17 of Bankruptcy Proceedings”). 

18 8.2.1 Notification of Bankruptcy Proceedings 

19 Regulation: 10 CFR 30.34(h) 

20 Criteria: Immediately following the filing of a voluntary or involuntary petition for bankruptcy for 

21 or against a licensee, the licensee must notify the appropriate NRC regional administrator, in 

22 writing, identifying the bankruptcy court in which the petition was filed and the date of filing. 

23 Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains 

24 subject to all applicable NRC regulatory requirements. The NRC must be notified when 

25 licensees are in bankruptcy proceedings in order to determine whether all licensed material is 

26 accounted for and adequately controlled and whether there are any public health and safety 

27 concerns (e.g., contaminated facility). The NRC shares the results of its determinations with 

28 other involved entities (e.g. trustee), so that health and safety issues can be resolved before 

29 bankruptcy actions are completed, and the NRC may request that the United States Department 

30 of Justice (DOJ) represent the NRC’s interests in the bankruptcy proceeding. 

31 Response from Applicant: None is required at the time of application for a new license. 

32 Licensees must immediately notify the NRC in writing following the filing of a voluntary or 

33 involuntary petition for bankruptcy by or against the licensee. 

34 Reference: See NUREG-1556, Volume 15, “Consolidated Guidance About Materials Licenses: 

35 Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or 

36 Special Nuclear Materials Licenses.” 
8-3 

1 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or 

2 Possessed 

3 Specify the street address, city, and State, or other descriptive address (e.g., “Highway 10, 

4 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State”) for each 

5 facility at which licensed material will be used or stored (e.g., include locations for field studies 

6 or other off-site locations; list activities to be conducted at each location). The descriptive 

7 address should be sufficient to allow an NRC inspector to find the facility location. A post office 

8 box address is not acceptable. In addition, applicants are encouraged to provide global 

9 positioning system coordinates, as appropriate. 

10 For security purposes, applicants are discouraged from identifying the self-shielded irradiator 

11 physical location by room number or providing drawings of the location within the facility. The 

12 acceptability of the irradiator’s location may be reviewed during an onsite visit as part of the 

13 licensing process and would also be subject to inspection following the issuance of a license. 

14 See Section 8.9, “Facilities and Equipment” for additional information. 

15 A license amendment is required before receiving, using, or storing licensed material at an 

16 address or location not already listed on the license. 

An NRC license does not relieve a licensee from complying with other applicable Federal, State, 

or local regulations (e.g., local zoning requirements). 

17 If an applicant submits documents that give the exact location of use and storage for any 

18 amount of radioactive material, the applicant should mark these documents as 

19 “Security-Related Information—Withhold Under 10 CFR 2.390.” See Chapter 6, “Identifying and 

20 Protecting Sensitive Information,” for more details. 

21 Note: As discussed in Section 8.5.2, “Financial Assurance and Recordkeeping for 

22 Decommissioning,” licensees must maintain permanent records describing where licensed 

23 material was used or stored while the license was in effect. This is important for making future 

24 determinations about the release of these locations for unrestricted use (e.g., before the license 

25 is terminated). Acceptable records are leak test records, sketches, written descriptions of the 

26 specific locations or room numbers where licensed material is used or stored and any records of 

27 leaking radioactive sources or other unusual occurrences involving the possible spread of 

28 contamination in or around the licensee’s facilities.
8-4 

P.O. Box XXXX

City, ST 12345

32 Elm St.

City, ST 12345

1556-002a.ppt

041300

32 ELM St.

P.O. Box XXXX

City, ST 12345

32 Elm St.

City, ST 12345

1556-002a.ppt

041300

32 ELM St. 32 ELM St.

An acceptable location of use or possession specifies street address, city, State, 

and zip code and does not include a post office box number. 

Figure 8-1. Location of Use or Possession 

1 8.4 Item 4: Person To Be Contacted about This Application 

2 Identify the individual who can answer questions about the application, and include a telephone 

3 number where the individual may be contacted as well as business cell phone numbers and 

4 e-mail addresses. This individual, usually the radiation safety officer (RSO), will serve as the 

5 point of contact during the review of the application. If this individual is not a full-time employee 

6 of the licensed entity, his or her position and relationship to the licensee should be specified. 

7 The NRC should be notified if the person assigned to this function changes or if his or her 

8 telephone number, cell phone number, or e-mail address changes. Notification of a contact 

9 change is only provided for informational purposes and would not be considered an application 

10 for license amendment, unless the notification involves a change in the contact person who is 

11 also the RSO. 

12 As indicated on NRC Form 313 (see Appendix A of this NUREG), Items 5 through 11 should be 

13 submitted on separate sheets of paper. Applicants may use Appendix B of this NUREG for this 

14 purpose and should note that using the suggested wording of responses and committing to use 

15 the model procedures in this NUREG will facilitate the NRC’s review. 

16 8.5 Item 5: Radioactive Material 

17 8.5.1 Sealed Sources and Devices 

18 Regulations: 10 CFR 20.1003, 10 CFR 20.2207, 10 CFR 30.32(g), 10 CFR 30.33(a)(2), 

19 10 CFR 32.201, 10 CFR 32.210, 10 CFR Part 37 

20 Criteria: Applicants should provide the manufacturer’s or distributor’s name and model number 

21 for each requested sealed source and device (e.g., irradiator unit). Licensees will be authorized 

22 to possess and use only those sealed sources and devices specifically registered with the NRC 

23 under 10 CFR 32.210, “Registration of product information,” or the equivalent regulations of an 
8-5 

1 Agreement State. Licensees must also protect aggregated Category 1 and Category 2 

2 quantities of radioactive material, as defined in 10 CFR 37.5, from theft, diversion, and 

3 sabotage.

4 Discussion: The NRC or an Agreement State performs a safety evaluation of self-shielded 

5 irradiators and the sealed sources contained in self-shielded irradiators under 10 CFR 32.210 or 

6 equivalent regulations of an Agreement State before authorizing a manufacturer or distributor to 

7 distribute the irradiators or sealed sources to specific licensees. The safety evaluation is 

8 documented in a Sealed Source and Device (SSD) registration certificate issued to the 

9 manufacturer or distributor. Applicants should provide the manufacturer’s or distributor’s name 

10 and model number for each requested sealed source and device so that the NRC can verify that 

11 they have been evaluated and registered with NRC under 10 CFR 32.210 or the equivalent 

12 regulations of an Agreement State. 

13 Before the formalization of the SSD registration process, some older irradiators might have 

14 been specifically approved by the NRC on a license. Existing NRC licensees can continue to 

15 use those units that are specifically approved and listed on their licenses. Possession and use 

16 of sealed sources and devices that have been specifically approved on a license must adhere to 

17 the commitments made in the license application and incorporated into the license. 

18 Applicants that request to possess or use sealed sources or a device that contains sealed 

19 sources that do not have SSD certificates and are not already approved on their existing license 

20 should provide the NRC with the information contained in 10 CFR 32.210(c). This will allow the 

21 NRC to perform an evaluation and make a determination as to whether the source or device can 

22 be approved for possession or use by the applicant. Such an evaluation will increase the time 

23 needed to process the licensing action. 

24 Self-shielded irradiators typically contain one or more sealed sources. Applicants should 

25 consult with the proposed manufacturer or distributor to ensure that requested sources and 

26 devices conform to the sealed source and device designations registered with the NRC or an 

27 Agreement State. Only authorized and approved sealed sources may be installed and used in 

28 the selected self-shielded irradiator model(s). Licensees may not make any changes to the 

29 sealed source, device, or source/device combination that would alter the description or 

30 specifications from those indicated in the respective registration certificates, without obtaining 

31 the NRC’s prior permission in a license amendment. Such changes might necessitate a custom 

32 registration review of the sealed source, device, or source/device combination, increasing the 

33 time needed to process a licensing action. 

34 In addition to the acceptable sealed sources that can be used in a device, the SSD registration 

35 certificates provide the leak test frequency and the ANSI Category of the irradiator. The SSD 

36 registration certificates also contain sections on “Conditions of Normal Use” and “Limitations 

37 and Other Considerations of Use.” These sections may include information about the sealed 

38 source/device from the manufacturer or distributor about particular conditions of use that are 

39 important to the radiation safety of the device, or by circumstances unique to the sealed source 

40 or device. For example, the working life of the device or an appropriate operating temperature 

41 and other environmental conditions may be specified. Except as specifically approved by the 

42 NRC, possession and use of sealed sources and devices must adhere to the conditions and 

43 limitations of the SSD registration certificate and the commitments made in the license 

44 application. Accordingly, applicants should acquire a copy of the SSD registration certificate(s) 

45 from the manufacturer or distributor, review it, and maintain it for future reference. 
8-6 

1 Information provided by the applicant/licensee regarding manufacturers, model numbers, and 

2 possession limits is considered sensitive information and should be marked accordingly (see 

3 Chapter 6, “Identifying and Protecting Sensitive Information”). 

4 Response from Applicant: 

5  Identify each radionuclide that will be used in each source in the self-shielded irradiators. 

6  Provide the manufacturer’s or distributor’s name and model number for each sealed 

7 source and device requested. 

8  For each source model, identify the radionuclide, activity per source, and maximum 

9 possession limit. The activity per source and maximum activity in each irradiator cannot 

10 exceed the maximum activity listed on the approved certificate of registration issued by 

11 NRC or by an Agreement State. 

12  State that each sealed source, device, and source/device combination is registered as 

13 an approved sealed source or device by the NRC or an Agreement State and will be 

14 possessed and used in accordance with the conditions specified in the SSD registration 

15 certificate. Obtain a copy of the SSD certificate from the manufacturer/distributor and 

16 provide the SSD registry number with the application. 

Mark the section of your application in which you identify sealed sources and devices with 

manufacturers’ model numbers and maximum possession limits with, “Security-Related 

Information—Withhold from Public Disclosure Under Title 10 of the Code of Federal Regulations

(CFR) 10 CFR 2.390.” In accordance with 10 CFR 2.390(b)(ii), the NRC is waiving the affidavit 

requirements. To the extent possible, your application should not include any personally 

private, proprietary, or safeguards information. 

17 8.5.2 Financial Assurance and Recordkeeping for Decommissioning 

18 Regulations: 10 CFR 30.34(b), 10 CFR 30.35, 10 CFR 30.51(f) 

19 Criteria: Self-shielded irradiator licensees authorized to possess sealed sources containing 

20 radioactive material in excess of the limits specified in 10 CFR 30.35, “Financial assurance and 

21 recordkeeping for decommissioning,” must provide evidence of financial assurance for 

22 decommissioning. Pursuant to 10 CFR 30.35(g), licensees must transfer records important to 

23 decommissioning to new proposed licensees before licensed activities are transferred, in 

24 accordance with 10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 30.51(f), before license 

25 termination, each licensee shall forward the records required by 10 CFR 30.35(g) to the 

26 appropriate NRC regional office. 

The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated “Category 

1 quantity of radioactive material” or “Category 2 quantity of radioactive material.’ These 

terms are defined in 10 CFR 37.5, and the radionuclides referenced in these 10 CFR 37.5 

definitions are listed in Appendix A to 10 CFR Part 37. See Section 8.10.6.2, “Security 

Program for Category 1 and Category 2 Radioactive Material,” of this NUREG for more 

information on the applicability and requirements of 10 CFR Part 37.
8-7 

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

2 location, records important to decommissioning. These records include as-built drawings and 

3 modifications of structures and equipment where irradiators are used or stored, as well as 

4 records related to leaking sources. 

5 Discussion: 

6 Financial Assurance 

7 The requirements for financial assurance are specific to the types and quantities of byproduct 

8 material authorized on a license. Most self-shielded irradiator applicants and licensees do not 

9 need to take any action to comply with the financial assurance requirements because their total 

10 inventory of licensed material does not exceed the limits in 10 CFR 30.35. The limits for typical 

11 self-shielded irradiator sealed sources are shown in Table 8-1. Applicants requesting more than 

12 one radionuclide need to use the sum-of-the-ratios method to determine whether financial 

13 assurance is needed. See Appendix E of this NUREG for additional information. 

Table 8-1. Minimum Inventory Quantity Requiring Financial Assurance 

Radionuclide in a Sealed Source 

Activity 

Gigabecquerel (GBq) Curie (Ci) 

Cs-137 3.7 × 106 100,000 

Co-60 3.7 × 105 10,000 

Sr-90 3.7 × 104 1,000 

14 Licensees may use the worksheet in Appendix E of this NUREG to determine whether they 

15 need to establish financial assurance if the only radioactive materials possessed are sealed 

16 sources in self-shielded irradiators. NRC licenses will indicate a maximum radionuclide 

17 possession limit. In most cases, a licensee would need to possess several irradiators before 

18 the financial assurance requirements would apply. Therefore, a self-shielded irradiator licensee 

19 can reduce the maximum possession limit to quantities not requiring financial assurance 

20 for decommissioning. 

21 Applicants and licensees wanting to possess sealed sources in self-shielded irradiators or other 

22 licensed materials exceeding the limits in 10 CFR 30.35 must submit evidence of financial 

23 assurance or a decommissioning funding plan [10 CFR 30.35 (b)]. Licensees may follow the 

24 guidance provided in NUREG-1757, Volume 3, “Consolidated Decommissioning 

25 Guidance - Financial Assurance, Recordkeeping, and Timeliness,” on the various financial 

26 assurance mechanisms authorized by the regulations to guarantee or secure funds. 

27 NRC may authorize possession exceeding the limits shown in Table 8-1 without requiring 

28 decommissioning financial assurance, for the purpose of normal source exchange for no more 

29 than 30 days. However, under no circumstances, including source exchange, should a licensee 

30 exceed the possession limits authorized by its license without NRC approval. 

31 Recordkeeping for Decommissioning 

32 The regulations in 10 CFR 30.35(g) also require that licensees maintain records important to 

33 decommissioning in an identified location. Licensees are required to maintain, in an identified 

34 location, decommissioning records related to structures and equipment where devices are used 
8-8 

1 or stored, as well as records related to leaking sources. Pursuant to 10 CFR 30.35(g), licensees 

2 must transfer records important to decommissioning to new licensees before licensed activities 

3 are transferred or assigned, according to 10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 

4 30.51(f), prior to license termination, each licensee shall forward the records required by 10 

5 CFR 30.35(g) to the appropriate NRC regional office. 

6 All self-shielded irradiator licensees need to maintain records of structures and equipment 

7 where each irradiator was used or stored. As-built drawings, with modifications of structures 

8 and equipment shown as appropriate, fulfill this requirement. If drawings are not available, 

9 licensees shall substitute appropriate records (e.g., a sketch of the room or building or a 

10 description of the area) concerning the specific areas and locations. If no records exist 

11 regarding structure and equipment where self-shielded irradiators were used or stored, 

12 licensees shall make all reasonable efforts to create such records based on historical 

13 information (e.g., employee recollections). In addition, self-shielded irradiator licensees that 

14 have experienced unusual occurrences (e.g., leaking sources or other incidents that involve 

15 spread of contamination) also need to maintain records about contamination that remains after 

16 cleanup or that might have spread to inaccessible areas. 

For self-shielded irradiator licensees whose sources have never leaked, acceptable records 

important to decommissioning are leak test results and sketches or written descriptions of the 

specific locations where each irradiator was used or stored. In addition, any transfer or 

disposal records shall be retained in accordance with 10 CFR 30.51(a)(3). 

17 Response from Applicant: 

18 State the following: “In accordance with 10 CFR 30.35(g), we shall maintain drawings and 

19 records important to decommissioning and shall transfer these records to an NRC or Agreement 

20 State licensee before licensed activities are transferred or forward the records to the appropriate 

21 NRC regional office before the license is terminated.” 

22 AND 

23 If financial assurance is required, submit evidence of financial assurance following the guidance 

24 of NUREG-1757, Volume 3. 

25 Reference: NUREG-1757, Volume 3, “Consolidated Decommissioning Guidance—Financial 

26 Assurance, Recordkeeping, and Timeliness.” 

27 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used 

28 Regulations: 10 CFR 30.33(a)(1), 10 CFR 32.210 

29 Criteria: An application for a license will be approved if the proposed activity is authorized by 

30 the Atomic Energy Act of 1954, as amended, and devices will be used only for the purposes for 

31 which they were designed and according to the manufacturer’s recommendations for use, as 

32 specified in an approved SSD registration certificate. 

33 Discussion: Allowed uses normally include the irradiation of blood, insects, animals, biological 

34 samples, and inanimate objects. Uses that are usually prohibited are the irradiation of 

35 flammable, corrosive, and explosive materials that might damage the integrity of the shielding or 
8-9 

1 the sealed source containment or the irradiation of other materials that might interfere with the 

2 safe operation of the device. 

3 Specific requirements related to the irradiation and distribution of food for human consumption 

4 are subject to regulations of the Food and Drug Administration and the U.S. Department of 

5 Agriculture and are not discussed in this document. Applicants should contact these agencies 

6 for further information. 

7 Requests to irradiate items prohibited or not listed in the SSD registration certificate will be 

8 reviewed on a case-by-case basis. Applicants need to submit enough information to 

9 demonstrate that irradiation of the proposed items will not compromise the integrity of the 

10 source, source shielding, or other components critical to the radiation safety of the device. 

11 Contact the appropriate NRC Regional Office (see Figure 2-1) for additional case-specific 

12 guidance. Being granted an NRC license does not relieve a licensee from complying with other 

13 applicable Federal, State, or local regulations. 

14 Response from Applicant: 

15 State the following: “We will not irradiate flammable, corrosive, or explosive materials.” 

16 

17 AND 

18 For all self-shielded irradiators that will be used for the purposes listed on the SSD registration 

19 certificate, state the following: 

20 If there is only a single irradiator, state: “This self-shielded irradiator will be used for the 

21 purposes described in its SSD registration certificate.” 

22 OR 

23 If there are multiple irradiators, state: “These self-shielded irradiators will be used for the 

24 purposes described in their respective SSD registration certificates.” 

25 OR 

26 For all self-shielded irradiators that will be used for purposes other than those listed on 

27 the SSD registration certificate, specify these purposes and submit safety analyses, 

28 including operating and emergency procedures and training, as necessary, to support 

29 safe use. The safety analyses should include enough information to demonstrate that 

For this purpose, “flammable” will mean any material with a flash point at a temperature 

below the temperature one would expect irradiated products to reach during irradiation. 

However, in no case should any material with a flash point below 62.78 degrees Celsius 

(145 degrees Fahrenheit) be irradiated. 

For this purpose, “corrosive” will mean any material with a pH less than 4.0 or greater 

than 10.0. 

Applicants may propose different definitions if justification is provided. 
8-10 

1 irradiation of the proposed items will not compromise the integrity of the source, source 

2 shielding, or other components critical to the radiation safety of the device. 

3 8.7 Item 7: Individual(s) Responsible for the Radiation Safety Program 

4 and Their Training Experience 

5 8.7.1 Radiation Safety Officer (RSO) 

6 Regulations: 10 CFR 30.33(a)(3), 10 CFR Part 37 

7 Criteria: RSOs must have training and experience that are adequate to ensure that the 

8 licensee’s radiation safety program is implemented in accordance with regulatory requirements, 

9 the terms and conditions of the license, and licensee procedures. Successful completion of 

10 training as described in Appendix F of this NUREG is evidence of adequate training and 

11 experience. 

12 Discussion: The person responsible for the radiation protection program is the RSO. The 

13 RSO is key to overseeing and ensuring safe operation of the licensee’s radiation protection 

14 program. The RSO must have adequate training to understand the hazards associated with 

15 radioactive material and be familiar with all applicable regulatory requirements. The RSO 

16 should have independent authority to stop operations that he or she considers unsafe. He or 

17 she should have sufficient time and commitment from management to fulfill his or her duties and 

18 responsibilities to ensure that radioactive materials are used in a safe manner, approved 

19 radiation safety procedures are being implemented, and the required records of licensed 

20 activities are maintained. Typical RSO duties are illustrated in Figure 8-2 and described in 

21 Appendix G of this NUREG. The NRC requires the name of the RSO to be listed on the license 

22 to ensure that licensee management always has a responsible, qualified person identified and 

23 that the named individual knows of his or her designation as RSO. Appendix H of this NUREG 

24 also provides a model Delegation of Authority, which should be used to further emphasize the 

25 agreement on duties and responsibilities of the RSO by management and the designated RSO. 

26 The RSO may delegate certain day-to-day tasks of the radiation protection program to other 

27 responsible individuals, sometimes referred to as “alternate RSOs” or “site RSOs.” For 

28 example, a licensee with multiple permanent locations of use or use at temporary jobsites may 

29 appoint “site RSOs,” who assist the RSO and are responsible for the day-to-day activities at 

30 these locations. Licensees may also appoint “alternate RSOs” who may “step in” as an 

31 emergency contact when the RSO is unavailable. Such “alternate RSOs” or “site RSOs” do not 

32 need to meet all RSO qualifications; however, they should be qualified, experienced authorized 

33 users who have adequate knowledge of the activities to which they are assigned. These 

34 individuals should have the same management support and decisionmaking authority as the 

35 RSO that is necessary to accomplish the tasks to which they have been assigned. Please note 

36 that only the primary RSO is named on an NRC license. 

37 For all broad scope licenses, the RSO must ensure that the licensee’s radioactive material is 

38 used and stored safely and securely according to approved policies and procedures and that all 

39 regulatory requirements are met. 
8-11 

Figure 8-2. Typical Duties and Responsibilities of RSOs 

1 For licensees possessing an aggregated amount of Category 1 or Category 2 quantity of 

2 radioactive material, the RSO should participate in the development and implementation of a 

3 security program for radioactive material in accordance with 10 CFR Part 37. A “Category 1 

4 quantity of radioactive material” and a “Category 2 quantity of radioactive material” are defined 

5 terms in 10 CFR 37.5, and the radionuclides referenced in these 10 CFR 37.5 definitions are 

6 listed in Appendix A to 10 CFR Part 37. 

7 Response from Applicant: Submit the following: 

8  the name of the proposed RSO 

9 AND EITHER 

10  this statement: “Before obtaining licensed materials, the proposed RSO will have 

11 successfully completed training described in Appendix F of NUREG-1556, Volume 5, 

12 Revision 1, ‘Consolidated Guidance About Materials Licenses: Program-Specific 

13 Guidance About Self-Shielded Irradiator Licenses.’” 

14 OR 

15  alternative information demonstrating that the proposed RSO is qualified by training 

16 and experience 

17 Note: Notify the NRC and obtain a license amendment before making changes in the 

18 designation of the RSO listed on the license. 

62-pt7-9162-100d.ppt

032498

Inventory

Leak Test

Audit

Training

Records

RSO

Responsibilities

Stop unsafe licensed activities

Proper use and routine maintenance

Irradiator security

Material disposal

Interaction with NRC, other authorities

Records maintenance

Annual program audit
8-12 

1 8.7.2 Authorized Users (AUs) 

2 Regulations: 10 CFR 30.33(a)(3) 

3 Criteria: Authorized users (AUs) must have adequate training and experience. Successful 

4 completion of training as described in Appendix F of this NUREG is evidence of adequate 

5 training and experience. 

6 Discussion: An AU is a person whose training and experience meet NRC criteria, who is 

7 named either explicitly or implicitly on the license, and who uses or directly supervises the use 

8 of licensed material or devices containing licensed material. AUs must ensure the proper use, 

9 security, and routine maintenance of self-shielded irradiators containing licensed material. They 

10 must have appropriate training to provide reasonable assurance that they will use the irradiator 

11 safely, maintain security of and access to the irradiator, and respond appropriately to accidents 

12 and malfunctions. 

13 An AU is considered to be supervising the use of licensed material when he or she directs 

14 personnel in operations involving the material or device. Although the AU may delegate specific 

15 tasks to supervised users (e.g., maintaining records), he or she is still responsible for the safe 

16 use and security of licensed material. 

17 Response from Applicant: Provide the name(s) of the AUs and submit either of the following: 

18  this statement: “Before using licensed material, authorized users will receive the training 

19 described in Appendix F of NUREG-1556, Volume 5, Revision 1, ‘Consolidated 

20 Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded 

21 Irradiator Licenses.’” 

22 OR 

23  alternative information demonstrating that the proposed AUs are qualified by training and 

24 experience 

25 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted 

26 Areas (Instructions to Occupational Workers and Ancillary Personnel) 

27 8.8.1 Instructions to Occupationally Exposed Radiation Workers 

28 Regulations: 10 CFR 19.12, 10 CFR 19.13, 10 CFR 30.33(a)(3), 10 CFR 37.43 

29 Criteria: For those individuals who are not AUs but are likely to receive in a year an 

30 occupational dose of radiation over 1 millisievert (mSv) [100 millirem (mrem)], the licensee must 

31 provide training as required by 10 CFR 19.12, “Instructions to workers.” The extent of this 

32 training must be commensurate with potential radiological health protection problems present in 

33 the workplace. Any licensee that possesses an aggregated Category 1 or Category 2 quantity 

34 of radioactive material (as defined in 10 CFR 37.5) must implement a training program for those 

35 individuals implementing the security program. 

36 Discussion: Personnel who will use the irradiator have the responsibility to ensure the proper 

37 use and security of irradiators containing licensed material and will need to be trained in the 

38 operating and emergency procedures to ensure the safe use of the licensed material. 
8-13 

1 Licensees need to perform a prospective evaluation to determine radiation doses likely to be 

2 received by different individuals or groups (see Section 8.10.3, “Occupational Dose”). AUs, 

3 individuals performing routine maintenance, and individuals performing installations, relocations, 

4 nonroutine maintenance, or repairs would be most likely to receive doses in excess of 1 mSv 

5 [100 mrem] in a year. See the previous section for a discussion of training and experience 

6 for AUs. 

7 Individuals other than AUs (e.g., biomedical engineers, radiation safety personnel, researchers) 

8 may perform routine maintenance on irradiators. However, they must either be trained in 

9 radiation safety and in the irradiator manufacturers’ or distributors’ operating and emergency 

10 procedures, or they must work under the supervision and in the direct physical presence of 

11 someone who has this training. Such individuals may also require escorting to comply with 

12 security requirements related to access to radioactive materials or devices containing 

13 radioactive materials. 

14 Some licensees might have specific individuals trained to perform installations, relocations, 

15 nonroutine maintenance, or repairs. Authorizations for these functions are separate from those 

16 for an AU or an individual who performs routine maintenance and will be specifically stated in a 

17 license condition. Appendix F of this NUREG contains suggested training for individuals who 

18 will conduct nonroutine maintenance. 

19 In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

20 Category 2 quantity of radioactive material must implement a training program in accordance 

21 with 10 CFR 37.43, “General security program requirements,” to ensure that those individuals 

22 who may have a responsibility to implement portions of the security program possess and 

23 maintain the knowledge, skills, and abilities to carry out their assigned duties and 

24 responsibilities effectively. For additional guidance on implementing 10 CFR Part 37 

25 requirements, see NUREG-2155, “Implementation Guidance for 10 CFR Part 37, “Physical 

26 Protection of Category 1 and Category 2 Quantities of Radioactive Material.’” Additional 

27 information regarding best practices for protection of risk-significant radioactive material is 

28 available in NUREG-2166, “Physical Security Best Practices for the Protection of Risk29 Significant Radioactive Material.” 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 

or Category 2 quantity of radioactive material must implement a training program in 

accordance with 10 CFR 37.43, “General security program requirements,” and specifically, 

must comply with 10 CFR 37.43(c), “Training,” to ensure that those individuals who may 

have a responsibility to implement portions of the security program possess and maintain 

the knowledge, skills, and abilities to carry out their assigned duties and responsibilities 

effectively. Additionally, in accordance with 10 CFR 37.43(c)(3), refresher training must be 

provided at a frequency not to exceed 12 months and when significant changes have been 

made to the security program. For additional guidance on implementing 10 CFR Part 37 

requirements, see NUREG-2155, “Implementation Guidance for 10 CFR Part 37, “Physical 

Protection of Category 1 and Category 2 Quantities of Radioactive Material.”” Additional 

information regarding best practices for protection of risk-significant radioactive material is 

available in NUREG-2166, “Physical Security Best Practices for the Protection of RiskSignificant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not to be submitted to the NRC, 

but may be subject to review and inspection.
8-14 

1 Response from Applicant: The applicant’s training program will be examined during 

2 inspections and should not be submitted in the license application. 

3 8.8.2 Instructions to Ancillary Workers 

4 Regulations: 10 CFR 19.12, 10 CFR 19.13, and 10 CFR 30.33(a)(3) 

5 Criteria: Those individuals who are not AUs or radiation workers but whose duties might 

6 require entry into the irradiator room (e.g., housekeeping, security, laboratory workers who do 

7 not use the irradiator) will need training commensurate to their duties. Personnel who might 

8 respond to alarms or work in the vicinity of the irradiator should be familiar with the 

9 emergency procedures. 

10 Discussion: Licensees need to perform a prospective evaluation to determine radiation doses 

11 likely to be received by different individuals or groups (see Section 8.10.3, “Occupational 

12 Dose”). While performing prospective evaluations, a licensee might recognize that some 

13 ancillary personnel, although not likely to receive doses over 1 mSv [100 mrem], should receive 

14 training commensurate with their involvement with licensed material. For example, 

15 housekeeping staff should receive training on the meaning of the radiation symbol and 

16 instructions on how to respond if the irradiator door was found open and the irradiator 

17 unattended. 

18 Response from Applicant: The applicant’s training program will be examined during 

19 inspections and should not be submitted in the license application.

20 8.9 Item 9: Facilities and Equipment 

21 Regulations: 10 CFR 30.33(a)(2), 10 CFR Part 37, 10 CFR 37.5, 10 CFR 37.49, 10 CFR 37.53 

22 Criteria: Facilities and equipment must be adequate to protect health and minimize danger to 

23 life or property and provide enhanced physical protection of aggregated Category 1 and 

24 Category 2 quantities of radioactive material, as defined in 10 CFR 37.5. 

25 Discussion: Self-shielded irradiators incorporate many engineering features to protect 

26 individuals from unnecessary radiation exposure. These devices are usually designed for use in 

27 a controlled environment, such as a laboratory, where the device is inside a building, protected 

28 from the weather, and not subject to wide variations of temperature and humidity. For 

29 information to help applicants determine the proper location of irradiators, applicants should 

30 refer to the device’s SSD registration certificate, paying close attention to the sections entitled 

31 “Conditions of Normal Use” and “Limitations and/or Other Considerations of Use.” 

32 If a proposed location for a self-shielded irradiator is not within the conditions of normal use or 

33 the limitations of use specified in the SSD registration certificate, the applicant should provide 

34 adequate justification for this deviation. In addition, the applicant might need to take 

35 compensatory measures (e.g., increased surveillance and maintenance) to ensure that the 

36 irradiator operates as designed and provides the intended level of protection. Information 

37 Notice (IN) 96-35, “Failure of Safety Systems on Self-Shielded Irradiators Because of 

38 Inadequate Maintenance and Training,” dated June 11, 1996, discusses an irradiator failure 

39 incident in which the lack of a climate-controlled environment (i.e., on the loading dock) might 

40 have accelerated the degradation of internal components leading to a failed interlock and an 

41 excessive dose received by an irradiator operator. 
8-15 

1 Self-shielded irradiators vary in weight from several hundred to several thousand pounds. As a 

2 comprehensive safety measure, before installing an irradiator, licensees should evaluate 

3 whether the floor in the proposed location can support the weight of the irradiator. If the 

4 irradiator will be moved between floors using an elevator, the licensee should evaluate whether 

5 the elevator can support the weight of the irradiator. Often licensees locate self-shielded 

6 irradiators on a ground floor. Based on the radioactivity of the licensed material, self-shielded 

7 irradiators require additional security measures to prevent unauthorized removal or access to 

8 the licensed materials or the device. For more information, see Section 8.10.2, “Radiation 

9 Safety Program - Operating and Emergency Procedures,” and Section 8.10.8, “Security 

10 Program for Category 1 and Category 2 Materials.” 

11 The fire-resistant properties of most irradiators should provide adequate radioactive material 

12 containment and shielding integrity in most situations; however, additional protection might be 

13 desirable for some situations. For example, the room housing the irradiator could be equipped 

14 with an automatically operated fire detection and control system (sprinkler, chemical, or gas). 

15 As an alternative, the self-shielded irradiator could be located under conditions (e.g., a ground16 floor location in a fire-resistant building with little combustible material) and other controls 

17 (e.g., coordination with and training of firefighting personnel) that help ensure a low level of 

18 radiation risk attributable to fires. 

19 As explained in an “Urgent Notice” with an enclosed Order, both dated July 3, 1984 

20 (see Appendix I of this NUREG), an NRC licensee identified a malfunction that could have 

21 resulted in a radiation overexposure. The malfunction involved an interlock mechanism, which 

22 would have failed to prevent a shielded door from being opened after the source had moved out 

23 of the shielded position. The Order, which remains in effect, modifies existing licenses that 

24 authorize J. L. Shepherd Mark I or Model 81-22 irradiators. Applicants wishing to use either of 

25 these models must comply with the Order’s requirements. The requirements of the Order will 

26 be imposed on the licensee through the use of a standard license condition on all licenses 

27 authorizing possession and use of J. L. Shepherd Mark I or Model 81-22 irradiators. 

28 Irradiators are equipped with electrical and mechanical safety interlocks to ensure that irradiator 

29 users are not exposed to the radiation. As noted above, these safety features might no longer 

30 function over time and need to be checked on a periodic basis. The irradiator user’s manual 

31 has instructions on how to perform these safety interlock checks. 
8-16 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things, 

 implement the physical protection requirements in 10 CFR Part 37 for material in use 

and storage, at both permanent and temporary jobsites; and 

 in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices, and immediately detect any unauthorized removal of Category 1 

quantities of radioactive material from the security zone. (Monitoring and detection 

systems may include, among other methods, monitored video surveillance systems and 

electronic devices for intrusion detection alarms.) 

 for mobile devices containing Category 1 or Category 2 quantities of radioactive 

material, have two independent physical controls to secure the material from 

unauthorized removal when the device is not under direct control and constant 

surveillance in accordance with 10 CFR 37.53. “Mobile device” is defined in 

10 CFR 37.5 

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and Category 

2 Quantities of Radioactive Material.”” Additional information regarding best practices for 

protection of risk-significant radioactive material is available in NUREG-2166, “Physical Security 

Best Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not to be submitted to the NRC, but 

may be subject to review and inspection.

1 Response from Applicant: 

2 Submit the following: 

3  this statement: “We will conduct electrical and mechanical safety interlock checks of 

4 each irradiator at least quarterly, in accordance with the irradiator’s user’s manual.” 

5 AND EITHER 

6  this statement: “We will ensure that each area where a self-shielded irradiator is located 

7 corresponds to the ‘Conditions of Normal Use’ and ‘Limitations and/or Other 

8 Considerations of Use’ on the applicable irradiator’s Sealed Source and Device 

9 registration certificate; the floor beneath the self-shielded irradiator is adequate to 

10 support the weight of the irradiator; each self-shielded irradiator is secured to prevent 

11 unauthorized access or removal; and each area where a self-shielded irradiator is 

12 located is equipped with an automatically operated fire-detection and -control system 

13 (sprinkler, chemical, or gas) or the location of the area and other controls ensure a low 

14 level of radiation risk attributable to fires.” 

15 OR 

16  alternative information; be sure to include justification for placing an irradiator in an area 
8-17 

1 that does not correspond to the “Conditions of Normal Use” and the “Limitations and/or 

2 Other Considerations of Use” 

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

4 References: Information Notices are available in the “NRC Library / Document Collections / 

5 Generic Communications” on NRC’s Home Page at http://www.nrc.gov. For hard copies, 

6 see the Notice of Availability on the inside front cover of this report. 

7 8.10 Item 10: Radiation Safety Program 

8 Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 30.33 

9 Criteria: A radiation safety program should be established by the applicant. The program 

10 should be commensurate with the scope and extent of activities for the use of licensed materials 

11 in self-shielded irradiators. Each applicant for a self-shielded irradiator license should develop, 

12 document, and implement a radiation protection program containing the following elements: 

13  steps to keep radiation exposures ALARA 

14  description of equipment and facilities adequate to protect personnel, the public, and 

15 the environment 

16  conduct of licensed activities by individuals qualified by training and experience 

17  written operating and emergency procedures to address all likely scenarios 

18  description of the organizational structure and of the individuals responsible for ensuring 

19 implementation of the radiation safety and security program 

20  records management 

21  implementation of an audit program to ensure that the radiation safety and security 

22 program are reviewed at least annually 

23 Discussion: The specific components of the applicant’s radiation safety and security program 

24 are detailed as separate topics in the remainder of this section. Some topics do not require a 

25 response from an applicant but are intended to provide guidance to the applicant on acceptable 

26 methods of compliance with specific NRC requirements. 

27 8.10.1 Audit and Review of Program 

28 Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 37.33, 10 CFR 37.55 

29 Criteria: Licensees must review the content and implementation of their radiation protection 

30 programs at least annually to ensure compliance with the provisions of NRC regulations, 

31 Orders, and the terms and conditions of the license in accordance with 10 CFR 20.1101(c). 

32 Licensees that are subject to the requirements in 10 CFR Part 37 must annually review their 

33 access authorization program and security program. Records of audits and other reviews of 

34 program content are maintained for 3 years after the record is made and in accordance with 10 

35 CFR 20.2102(b), 10 CFR 37.33(c), and 10 CFR 37.55(c). 
8-18 

1 Discussion: Appendix J of this NUREG contains a suggested annual audit program that is 

2 specific to the use of self-shielded irradiators and is acceptable to the NRC. Since all areas 

3 indicated in Appendix J may not be applicable to every licensee and all items may not need to 

4 be addressed during each audit, licensees may wish to develop a program-specific audit 

5 checklist. 

6 The NRC encourages licensee management to conduct performance-based reviews by 

7 observing work in progress, interviewing staff, and spot-checking required records. As part of 

8 the audit program, licensees should consider including unannounced audits of self-shielded 

9 irradiator users to observe whether radiation safety procedures are being followed. 

10 It is essential that once problems are identified, comprehensive corrective actions are taken in a 

11 timely manner. Information Notice (IN) 96-28, “Suggested Guidance Relating to Development 

12 and Implementation of Corrective Action,” dated May 1, 1996, provides guidance on this 

13 subject. The NRC routinely reviews licensee’s records to verify whether appropriate corrective 

14 actions were implemented in a timely manner to address recurrence. It is in the best interest of 

15 the licensee to identify potential violations of regulatory requirements and take necessary steps 

16 to correct them. The NRC can opt to exercise discretion and may elect not to cite the licensee 

17 for these violations if prompt and effective corrective actions are implemented. The NRC’s 

18 Enforcement Policy may be found online at http://www.nrc.gov/about19 nrc/regulatory/enforcement/enforce-pol.html, and the Enforcement Manual may be found online 

20 at http://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. For examples of the 

21 NRC’s use of discretion in issuing a notice of violation, refer to the most recent version of NRC’s 

22 enforcement documents at http://www.nrc.gov/reading-rm/doc-collections/enforcement/. 

23 With regard to audit records, 10 CFR 20.2102 requires, in part, that licensees maintain records 

24 of “audits and other reviews of program content and implementation” for 3 years after the record 

25 is made. The NRC has found audit records that contain the following information to be 

26 acceptable: date of audit, name of person(s) who conducted audit, persons contacted by the 

27 auditor(s), areas audited, audit findings, corrective actions, and followup. 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things, 

 in accordance with 10 CFR 37.33, review its access authorization programs at least 

annually to confirm compliance with the requirements of Subpart B of 10 CFR Part 37 

and ensure that comprehensive actions are taken to correct any noncompliance that is 

identified; and 

 in accordance with 10 CFR 37.55, review its security program at least annually to 

confirm compliance with the requirements of Subpart C of 10 CFR Part 37 and ensure 

that comprehensive actions are taken to correct any noncompliance that is identified. 

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not to be submitted to the NRC, but 

may be subject to review and inspection.
8-19 

1 Response from Applicant: The applicant’s program for reviewing the content and 

2 implementation of its radiation protection program, access authorization program, and 

3 security program will be examined during inspections and should not be submitted with the 

4 license application. 

5 References: 

6 NRC’s Enforcement Policy may be found online at 

7 http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html and the Enforcement 

8 Manual may be found online at 

9 http://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. 

10 IN 96-28, “Suggested Guidance Relating to Development and Implementation of Corrective 

11 Action,” dated May 1, 1996. 

12  NRC Inspection Procedure 87122, “Irradiator Programs 

13 8.10.2 Radiation Monitoring Instruments 

14 Regulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2) 

15 Criteria: Pursuant to 10 CFR 20.1501, “General,” licensees must possess, or have access to, 

16 radiation monitoring instruments that are necessary to protect health and minimize danger to life 

17 or property. Instruments used for quantitative radiation measurements must be calibrated 

18 periodically for the radiation measured. 

19 Discussion: All licensees possessing self-shielded irradiators should have, or have access to, 

20 calibrated radiation detection instruments to determine radiation levels in areas adjacent to the 

21 irradiator. Usually it is not necessary for a licensee to have a radiation survey meter solely for 

22 use during irradiator operations, because it is not expected that a survey be performed each 

23 time a sample is irradiated. In these cases, it is acceptable for the meter to be available on 

24 short notice in the event of an accident or malfunction that could reduce the shielding of the 

25 sealed source(s). Surveys may be required to verify source integrity and to ensure that dose 

26 rates in unrestricted areas and public and occupational doses are within regulatory limits. 

27 As explained in an “Urgent Notice” with an enclosed Order, both dated July 3, 1984 

28 (see Appendix I of this NUREG), an NRC licensee identified a malfunction that could have 

29 resulted in a radiation overexposure. The malfunction involved an interlock mechanism, which 

30 would have failed to prevent a shielded door from being opened after the source had moved out 

31 of the shielded position. The Order, which remains in effect, modifies licenses that authorize 

32 J. L. Shepherd Mark I or Model 81-22 irradiators and requires licensees to provide either a 

33 calibrated and operable radiation survey meter or a room monitor for use with either of these 

34 irradiators. Although not required for all licensees possessing moving-source irradiators, it 

35 would be prudent for these licensees to use either a calibrated radiation survey meter or room 

36 monitor to ensure that the sources are in the shielded position whenever a sample is not 

37 undergoing irradiation. 

38 The NRC requires that radiation survey meter calibrations be performed by the instrument 

39 manufacturer or a person specifically authorized by the NRC or an Agreement State, unless the 

40 applicant specifically requests authorization to do this themselves. Applicants seeking 
8-20 

1 authorization to perform survey-meter calibrations should submit additional information for 

2 review. See Appendix K of this NUREG for more information. Regardless of whether an 

3 applicant is authorized to calibrate radiation survey meters or contracts an authorized firm to 

4 perform calibrations, the licensee must retain records of the calibration of instruments and 

5 equipment used for quantitative radiation measurements for 3 years after the record is made in 

6 accordance with 10 CFR 20.2103(a). 

7 Response from Applicant: 

8 Submit one of the following: 

9  this statement: “We will use instruments that meet the radiation-monitoring instrument 

10 specifications published in Appendix K of NUREG-1556, Volume 5, Revision 1, 

11 ‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 

12 Self-Shielded Irradiator Licenses.’” Additionally, each radiation survey meter will have 

13 been calibrated by the manufacturer or other person authorized by the NRC or an 

14 Agreement State to perform radiation survey meter calibrations no more than 12 months 

15 before the date the meter is used.” 

16 OR 

17  this statement: “We will use instruments that meet the radiation-monitoring instrument 

18 specifications published in Appendix K of NUREG-1556, Volume 5, Revision 1, 

19 ‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 

20 Self-Shielded Irradiator Licenses.’” Additionally, we will implement the model radiation 

21 survey meter calibration program published in Appendix K of this NUREG-1556, and we 

22 will ensure that each radiation survey meter will have been calibrated no more than 

23 12 months before the date the meter is used.” 

24 OR 

25  a description of alternative equipment and/or procedures for (1) ensuring that interlocks 

26 function as required to return moving self-shielded irradiator sources to the shielded 

27 position, and (2) determining source shielding integrity after an incident involving the 

28 self-shielded irradiator. 

29 Notes: 

30  Alternative responses will be reviewed using the criteria listed above. 

31  Licenses authorizing J. L. Shepherd Mark I or Model 81-22 irradiators will contain license 

32 conditions to require compliance with the terms of the Order in Appendix I of this 

33 NUREG. Applicants requesting these irradiators must ensure that their radiation 

34 detection instruments meet these requirements. 

35  Applicants who plan to perform nonroutine maintenance that will affect safety-critical 

36 components (e.g., sealed source, radiation shielding, source movement control or 

37 mechanism, or interlocks) will need to possess and use appropriate calibrated radiation 

38 survey meters. Refer to the section on “Radiation Safety Program - Maintenance” and 

39 Appendices M and N of this NUREG for more information. 
8-21 

1  Required calibration records must be retained for a minimum of 3 years. 

2 8.10.3 Material Receipt and Accountability 

3 Regulations: 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2201, 10 CFR 20.2207, 

4 10 CFR 30.34(e), 10 CFR 30.35(g)(2), 10 CFR 30.41, 10 CFR 30.51, 10 CFR 37.49, 10 CFR 

5 37.71, 10 CFR 37.75, 10 CFR 37.77, 10 CFR 110.28, 10 CFR 110.29, 10 CFR 110.31, 10 CFR 

6 110.32, 10 CFR 110.42, 10 CFR 110.43, 10 CFR 110.44 

7 Criteria: Licensees must do the following: 

8  Conduct physical inventories at intervals not to exceed 6 months (or some other interval 

9 justified by the applicant and approved by the NRC) to account for all sealed sources in 

10 accordance with license condition. 

11  Maintain records of receipt, transfer, and disposal of licensed material. 

12  Update transactions in the National Source Tracking System (NSTS), including 

13 performing annual inventory reconciliation, if applicable. 

14  Before transferring aggregated Category 1 or Category 2 quantities of radioactive 

15 material listed in Appendix A to 10 CFR Part 37, use NRC’s license verification system 

16 to verify that the recipient licensee is authorized to possess the radioactive material. 

17  Preplan, coordinate, and provide advance notification of shipment of Category 1 

18 quantities of radioactive material and coordinate shipment of Category 2 quantities of 

19 radioactive material listed in Appendix A to 10 CFR Part 37. 

20 Discussion: 

21 8.10.3.1 Inventory 

22 While loss, theft, or misplacement of most self-shielded irradiators is unlikely because of their 

23 size and weight, accountability for licensed materials must be ensured; see Figure 8-3. Many 

24 licensees record use of self-shielded irradiators in a log book. Licensees are also required to 

25 conduct leak tests of irradiator sealed source(s) at the frequency specified in the SSD 

26 registration certificate. Because both of these activities require that an individual approach the 

27 irradiator, records of use and leak tests may be used as part of an accountability program. For 

28 more information, see Section 8.10.6, “Radiation Safety Program – Operating, Emergency, and 

29 Security Procedures,” and Section 8.10.7, “Radiation Safety Program - Leak Tests,” in this 

30 NUREG. However, because some irradiators might not be in use or are used rarely, licensee 

31 shall continue to physically approach and account for all sealed sources at least every 

32 6 months. For aggregated Category 1 and Category 2 quantities of radioactive material, 

33 licensees must, according to 10 CFR 37.49(a)(1), continuously monitor and detect, without 

34 delay, all unauthorized entries into security zones. Additionally, for Category 1 quantities of 

35 radioactive material, 10 CFR 37.49(a)(3)(i) requires immediate detection of any attempted 

36 unauthorized removal of the radioactive material from the security zone. For Category 2 

37 quantities of radioactive material, 10 CFR 37.49(a)(3)(ii) requires weekly verification through 

38 physical checks, tamper indicating devices, use, or other means to ensure that the radioactive 

39 material is present. 
8-22 

1 Licensees are required under 10 CFR 20.1801 and 20.1802 to secure radioactive materials 

2 from unauthorized removal or access while in storage in controlled or unrestricted areas and to 

3 control and maintain constant surveillance over licensed material that is in a controlled or 

4 unrestricted area and is not in storage. Applicants should establish policies and procedures for 

5 ensuring accountability of licensed materials. Licensed materials should be tracked from receipt 

6 to transfer to ensure accountability at all times; to identify when licensed material may be lost, 

7 stolen, or misplaced; and to ensure that the possession limit stated on the license is not 

8 exceeded. 

Figure 8-3. Material Receipt and Accountability 

9 8.10.3.2 National Source Tracking System (NSTS) 

10 As illustrated in Figure 8-3, licensed materials must be tracked from receipt to disposal, to 

11 ensure accountability and ensure that possession limits listed on the license are not exceeded. 

12 Furthermore, if source activity exceeds the activities listed in Appendix E, “Nationally Tracked 

13 Source Thresholds,” to 10 CFR Part 20, the transfer transaction (receipt, transfer, and disposal) 

14 must be reported in accordance with 10 CFR 20.2207, “Reports of transactions involving 

15 nationally tracked sources.” 

16 Pursuant to 10 CFR 20.1003, “Definitions,” a “nationally tracked source” is a sealed source 

17 containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive 

18 material listed in Appendix E to 10 CFR Part 20. For example, the Category 2 value provided 

19 for cesium-137 is 1 TBq [27 Ci]. The cesium-137 sources used in self-shielded irradiators are 

20 usually at or above the Category 2 quantities listed in Appendix E to 10 CFR Part 20. 
8-23 

Category 1 and Category 2 sealed sources listed in Appendix E to 10 CFR Part 20 (i.e., 

nationally tracked sources) must be tracked in the National Source Tracking System (NSTS) in 

accordance with 10 CFR 20.2207. The regulations in 10 CFR 20.2207 require that each 

licensee that manufactures, transfers, receives, disassembles, or disposes of a nationally 

tracked source shall complete and submit a National Source Tracking Transaction Report 

(NSTTR) to the NRC. The NSTTRs are maintained in the NSTS, a secure computer system 

that tracks Category 1 and Category 2 nationally tracked sources from the time they are 

manufactured or imported through the time of their disposal or export, or until the source activity 

decays to below Category 2. 

1 8.10.3.3 Decommissioning Records 

2 Receipt, inventory, transfer, and disposal records must be maintained for the times specified in 

3 Table 8-2. Typically, these records contain the following types of information: 

4  radionuclide and the activity (in units of becquerels or curies) of byproduct material in 

5 each sealed source 

6  manufacturer’s or distributor’s name, model number, and serial number (if appropriate) 

7 of each device containing byproduct material 

8  location of each sealed source and device 

9  for inventories, the date of inventory, and name and signature of the individual 

10 conducting the inventory 

11  for materials transferred or disposed of, the date of the transfer or disposal, the name 

12 and license number of the recipient, and a description of the affected radioactive 

13 material (e.g., radionuclide, activity, manufacturer’s or distributor’s name and model 

14 number, serial number) 

15 Information on locations where irradiators are used or stored are records important to 

16 decommissioning and are required by 10 CFR 30.35(g)(2). 

Table 8-2. Record Maintenance 

Type of Record How Long Record Must Be Maintained 

Receipt For as long as the material is possessed and for 3 years following the 

transfer or disposal of the material 

Inventory For 5 years from the date of the inventory in accordance with license 

conditions 

Transfer For 3 years after each transfer, unless a specific requirement dictates 

otherwise 

Disposal Until NRC terminates the license 

Important to 

decommissioning* 

Until the site is released for unrestricted use 

* See Section 8.5.2 entitled, “Financial Assurance and Recordkeeping for Decommissioning,” for more details. 

NOTE: If the sealed source(s) will be procured from a company outside the U.S., the NRC licensee must comply 

with the import regulations listed in 10 CFR Part 110. The same applies for exports of byproduct material. 
8-24 

There are additional security requirements for shipment and transfer of a Category 1 and 

Category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part 37. Prior to 

transferring Category 1 or Category 2 quantities of radioactive material, licensees must use 

NRC’s license verification system (or contact the licensing authority) to verify that the recipient 

licensee is authorized to possess the radioactive material. Licensees that ship Category 1 or 

Category 2 quantities of radioactive material must preplan and coordinate such shipments in 

accordance with 10 CFR 37.75. Shipments of Category 1 quantities are also subject to the 10 

CFR 37.77 advance notification requirements. For additional guidance on implementing 

10 CFR Part 37 requirements, see NUREG-2155, “Implementation Guidance for 10 CFR Part 

37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.”” 

Additional information regarding best practices for protection of risk-significant radioactive 

material is available in NUREG-2166, “Physical Security Best Practices for the Protection of 

Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection. 

1 Response from Applicant: 

2 Submit the following: 

3  the statement: “We will develop, implement, and maintain procedures for ensuring 

4 accountability of licensed materials at all times.” 

5 AND 

6  the statement: “Physical inventories will be conducted and documented at intervals not 

7 to exceed 6 months to account for all sealed sources and devices received and 

8 possessed under the license.” 

9 AND 

10  If applicable, provide the following statement: “We will comply with the National Source 

11 Tracking System (NSTS) reporting requirement as described in 10 CFR 20.2207.” 

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

13 8.10.4 Occupational Dose 

14 Regulations: 10 CFR 19.13, 10 CFR 20.1101, 10 CFR 20.1201, 10 CFR 20.1202, 

15 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1501, 10 CFR 20.1502, 10 CFR 20.2104, 

16 10 CFR 20.2106 

17 Criteria: Applicants must do either of the following: 

18  Perform a prospective evaluation demonstrating that unmonitored individuals are not 

19 likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502(a), and 

20 maintain a record of this evaluation for inspection by the NRC. 

21 OR 
8-25 

Total effective dose equivalent (TEDE) equals the effective dose equivalent (for external 

exposures) plus the committed effective dose equivalent (for internal exposures). 

1  provide and require the use of individual monitoring devices (dosimetry) (All personnel 

2 dosimeters that require processing to determine the radiation dose must be processed 

3 and evaluated by a National Voluntary Laboratory Accreditation Program (NVLAP)-

4 approved processor.) 

5 Discussion: Licensees must evaluate the potential occupational exposure of all workers and 

6 monitor occupational exposure. When personnel monitoring is required, for all personnel 

7 dosimeters that require processing to determine the radiation dose, licensees must use 

8 dosimeters supplied by an NVLAP-approved processor. The exchange frequency for 

9 dosimeters is typically monthly or quarterly. Applicants should consult with their 

10 NVLAP-approved processor for its recommendations for exchange frequency and proper use of 

11 the dosimeter. 

12 The annual dose limits for adult radiation workers are shown in Figure 8-4. Note that in 

13 accordance with 10 CFR 20.1207, the annual occupational dose limits for minors are 10 percent 

14 of the annual dose limits specified for adult workers. Also, 10 CFR 20.1208 requires the 

15 licensee to ensure that the dose equivalent to the embryo/fetus during the entire pregnancy, due 

16 to the occupational exposure of a declared pregnant woman, does not exceed 0.5 rem [5 mSv]. 

Figure 8-4. Annual Dose Limits for Adult Radiation Workers 

17 The use of individual monitoring devices for external dose is required, pursuant to 

18 10 CFR 20.1502(a), for 

19  adults who are likely to receive an annual dose from sources external to the body in 

20 excess of any of the following (each evaluated separately) 

21 — 5 mSv [0.5 rem] deep-dose equivalent 

22 — 15 mSv [1.5 rems] lens (of the eye) dose equivalent 
8-26 

1 — 50 mSv [5 rems] shallow-dose equivalent to the skin 

2 — 50 mSv [5 rems] shallow-dose equivalent to any extremity 

3  minors who are likely to receive an annual dose from sources external to the body in 

4 excess of any of the following (each evaluated separately) 

5 — 1.0 mSv [0.1 rem] deep-dose equivalent 

6 — 1.5 mSv [0.15 rem] lens (of the eye) dose equivalent 

7 — 5 mSv [0.5 rem] shallow-dose equivalent to the skin 

8 — 5 mSv [0.5 rem] shallow-dose equivalent to any extremity 

9  declared pregnant women who are likely to receive a dose from radiation sources 

10 external to the body during the entire pregnancy in excess of 1.0 mSv [0.1 rem] deep11 dose equivalent 

12  individuals entering a high or very high radiation area 

13 Under conditions of routine use, typically a worker does not require an individual monitoring 

14 device (dosimetry). A worker also may not require dosimetry when proper emergency 

15 procedures are followed. Appendix L of this NUREG provides guidance on performing a 

16 prospective evaluation demonstrating that workers are not likely to exceed the limits in 

17 10 CFR 20.1502(a) and thus are not required to have personnel dosimetry. 

18 Workers who perform nonroutine maintenance such as any repair, removal, replacement, or 

19 alteration involving (i) electrical and mechanical systems that control source or shielding 

20 movement, (ii) the irradiator’s shielding or sealed source, (iii) safety interlocks, or (iv) any 

21 component that may affect safe operation of the irradiator, are more likely than workers who 

22 only engage in routine activities to exceed the limits in 10 CFR 20.1502(a). Applicants must 

23 provide dosimetry (whole body and perhaps extremity monitors) to workers who perform 

24 nonroutine operations or must perform a prospective evaluation demonstrating that unmonitored 

25 workers who perform nonroutine operations are not likely to receive radiation doses in excess of 

26 the limits in 10 CFR 20.1502(a). 

27 Response from Applicant: Provide any one of the following: 

28  the statement: “We will maintain, for inspection by the NRC, documentation 

29 demonstrating that unmonitored individuals are not likely to receive a radiation dose in 

30 excess of the limits in 10 CFR 20.1502(a).” 

31 OR 

32  the statement: We will provide and require the use of individual monitoring devices 

33 (dosimetry). All personnel dosimeters that require processing to determine the radiation 

34 dose will be processed and evaluated by a NVLAP-approved processor.” 

35 OR 
8-27 

1  a description of an alternative method for demonstrating compliance with the referenced 

2 regulations. 

3 Notes:

4  Alternative methods for demonstrating compliance with the referenced regulations will be 

5 evaluated against the previously listed criteria. 

6  Some licensees choose to provide personnel dosimetry to their workers for reasons 

7 other than compliance with NRC requirements (e.g., to respond to worker requests or to 

8 maintain records of personal exposure). 

9 Reference: The National Institute of Standards and Technology maintains a directory of 

10 laboratories that are NVLAP-approved at http://ts.nist.gov/standards/scopes/dosim.htm.

11 8.10.5 Public Dose 

12 Regulations: 10 CFR 20.1301, 10 CFR 20.1302, 10 CFR 20.2107 

13 Criteria: Licensees must ensure that self-shielded irradiators will be used, transported, and 

14 stored in such a way that members of the public will not receive more than 100 mrem [1 mSv] in 

15 a year and the dose from licensed operations in any unrestricted area will not exceed 2 mrem 

16 [0.02 mSv] in any 1 hour. 

17 Discussion: Public dose is defined in 10 CFR Part 20 as “the dose received by a member of 

18 the public from exposure to radiation or to radioactive material released by a licensee, or to any 

19 other source of radiation under the control of a licensee.” Public dose excludes doses received 

20 from background radiation and medical procedures. Whether the dose to an individual is an 

21 occupational dose or a public dose depends on the individual’s assigned duties. It does not 

22 depend on the area (restricted, controlled, or unrestricted) where the individual is when he or 

23 she receives the dose.

24 In the case of self-shielded irradiators, members of the public include persons who work or may 

25 be near locations where self-shielded irradiators are used or stored and employees whose 

26 assigned duties do not include the use of licensed materials and who work in the vicinity where 

27 irradiators are used or stored. 

28 The licensee’s operating and emergency procedures should be effective in limiting the exposure 

29 to the public during use or storage. See Figure 8-5. Public dose is controlled, in part, by 

30 ensuring that irradiators are secure (e.g., located in a locked area) to prevent unauthorized 

31 access or use. Irradiator use is usually restricted by controlling access to (i) the keys needed to 

32 operate the irradiator and/or (ii) the keys or other access-control devices (e.g., keycards, 

33 biometric identification, cipher locks, proximity readers) to the locked irradiator area. Only 

34 authorized users should have access to these keys and other access-control devices. 
8-28 

Irradiators should be located away from occupied areas and secured to prevent unauthorized use or 

removal. 

Figure 8-5. Proper Location of Irradiator 

1 Public dose is also affected by the choice of storage and use locations and conditions. Because 

2 a self-shielded irradiator presents a radiation field, it must be located so that the radiation level 

3 in an unrestricted area (e.g., an office or the exterior surface of an outside wall) does not exceed 

4 100 mrem [1 mSv] in a year or 2 mrem [0.02 mSv] in any 1 hour. Use the concepts of time, 

5 distance, and shielding when choosing storage and use locations. Decreasing the time spent 

6 near an irradiator, increasing the distance from the irradiator, and using shielding (i.e., brick, 

7 concrete, lead, or other solid walls) will reduce the radiation exposure. 

8 Licensees can determine the radiation levels adjacent to the irradiator location either by 

9 calculations or a combination of direct measurements and calculations using some or all of the 

10 following: (i) typical known radiation levels provided by the irradiator manufacturer or distributor, 

11 (ii) the inverse square law to evaluate the effect of distance on radiation levels, (iii) the 

12 occupancy factor to account for the actual presence of members of the public, and (iv) limits on 

13 the use of the self-shielded irradiator(s). See Appendix M of this NUREG for an example. 

14 If, after making an initial evaluation, a licensee changes the conditions used for the evaluation 

15 (e.g., changes the location of irradiators, changes the type or frequency of irradiator use, adds 

16 self-shielded irradiators, or changes the occupancy of adjacent areas), the licensee must 

17 perform a new evaluation to ensure that the public dose limits are not exceeded and take 

18 corrective action as needed in accordance with 10 CFR 20.1302, “Compliance with dose limits 

19 for individual members of the public.” 

20 During NRC inspections, licensees must be able to provide documentation in accordance with 

21 10 CFR 20.2107, “Records of dose to individual members of the public,” demonstrating, by 

22 measurement or calculation, that the TEDE to the individual likely to receive the highest dose 

23 from the licensed operation does not exceed the annual limit for members of the public. See 

24 Appendix M of this NUREG for examples of methods to demonstrate compliance. 

25 Response from Applicant: No response is required from the applicant in a license application, 

26 but documentation demonstrating compliance will be examined during inspection. 
8-29 

1 8.10.6 Operating, Emergency, and Security Procedures 

2 Regulations: 10 CFR 30.34(e); 10 CFR 20.1101; 10 CFR 20.1801; 10 CFR 20.1802; 

3 10 CFR 20.2202; 10 CFR 20.2203; 10 CFR 20.2207; 10 CFR 30.50; 10 CFR 21.21; 

4 10 CFR 19.11(a)(3); 10 CFR 37 (Subpart B); 10 CFR 37.21(a); 10 CFR 37.45; 10 CFR 37.49 

5 Criteria: Licensee’s must have written operating and emergency procedures. Licensees that 

6 possess an aggregated Category 1 or Category 2 quantity of radioactive material, listed in 

7 Appendix A to 10 CFR Part 37, must also establish, implement, and maintain its access 

8 authorization program; coordinate, to the extent practicable, with local law enforcement 

9 authorities, for responding to threats to the licensee’s facility; and be able to monitor, detect 

10 without delay, assess, and respond to any unauthorized entries into security zones. 

11 8.10.6.1 Operating and Emergency Procedures 

12 Before using an irradiator, licensees must: 

13  Commit to implement the manufacturer’s or distributor’s operating and 

14 emergency procedures. 

15 OR 

16  Develop, implement, and maintain model-specific operating and emergency procedures 

17 that contain these elements: 

18 — an analysis of each type of material to be placed in the irradiator to ensure that it 

19 is compatible with the irradiator’s design as described in the irradiator’s SSD 

20 registration certificate 

21 — special safety procedures (if materials to be irradiated are not compatible and 

22 special safety procedures are determined to be needed) 

23 — instructions for using the self-shielded irradiator and performing routine 

24 maintenance according to the manufacturer’s or distributor’s written 

25 recommendations and instructions 

26 — instructions for maintaining security to prevent unauthorized use, access, or 

27 removal of self-shielded irradiators and the associated sealed sources 

28 — steps to take to keep radiation exposures ALARA 

29 — steps to maintain accountability 

30 — steps to control access to a malfunctioning or damaged irradiator 

31 — emergency procedures that include which steps to take and whom to contact 

32 (e.g., RSO, local officials, regulatory agency). These should address the 

33 following relatively likely scenarios: 

34 – leaking source 

35 – failure of safety interlocks 
8-30 

1 – alarming radiation monitor inside irradiator room 

2 – toppled-over irradiator (during movement to another location) 

3 – natural disaster (flood, tornado, earthquake, etc.) 

4 – security alarm for unauthorized access 

5 AND 

6  Train personnel in the operating and emergency procedures and make copies available 

7 to all users. 

8 AND 

9  Keep a current copy of operating and emergency procedures at each irradiator’s control 

10 panel (or, if this is not practicable, post a notice describing the procedures and stating 

11 where they may be examined). 

12 Discussion: When used as designed, properly functioning self-shielded irradiators pose little 

13 radiation safety risk. However, improper maintenance, irradiating material incompatible with an 

14 irradiator’s design, or operating an irradiator in an environment other than that recommended by 

15 the manufacturer or distributor could lead to damage or malfunction of an irradiator and elevated 

16 exposure rates in the irradiator’s immediate vicinity. Operating and emergency procedures 

17 should be developed to minimize these risks while keeping radiation exposures ALARA. These 

18 procedures should be model-specific to account for potentially significant differences in 

19 irradiator design and construction that lead to manufacturers (or distributors) providing different 

20 instructions and recommendations for operating and maintaining irradiators. 

21 Sources contained in many self-shielded irradiators are designed to deliver significant radiation 

22 doses in short periods of time. Although self-shielded irradiators are safe when used correctly, 

23 unauthorized access to the irradiator or the irradiator’s sources by untrained individuals could 

24 lead to a life-threatening situation. Therefore, operating procedures will also need to address 

25 access control and accountability. Many licensees achieve access control by permitting only 

26 AUs or the RSO to have access to the keys for the irradiator and/or the irradiator area. 

27 Accountability of an operating irradiator may be ensured by using a log book to record irradiator 

28 use, maintenance, service calls, and sealed-source leak tests. Each activity requires an 

29 individual to interact in some way with the irradiator and thereby verify its presence. For 

30 sources contained in irradiators that are not actively used, licensees would need to find other 

31 methods to maintain accountability, such as conducting inventories. 

32 Licensees should post current copies of the operating procedures applicable to licensed 

33 activities (e.g., at the irradiator control panel). If posting of a document is not practicable, the 

34 licensee may post a notice that describes the document and states where it may be examined. 

35 Figure 8-6 illustrates a proper response to a fire in an irradiator. Emergency procedures should 

36 be developed to address a spectrum of incidents (e.g., interlock failure, flood, tornado, 

37 earthquake, leaking source, radiation monitor sounding an alarm inside the irradiator room, 

38 security-system alarm). Emergency response procedures should include the following 

39 elements: 

40  Leave the irradiator room to reduce radiation exposure. 

41  Control access (e.g., lock the door). 
8-31 

1  Contact the RSO for further instructions and to initiate emergency response. 

2 (Telephone numbers for the RSO, other responsible individuals, the irradiator 

3 manufacturer or distributor or its representative, the local law enforcement agency, the 

4 fire department or other emergency response organization, and the NRC should be 

5 posted or easily accessible.) 

6  Survey areas outside the irradiator room to determine whether further restriction of the 

7 area is necessary to ensure that no one can enter the area if the radiation level exceeds 

8 0.02 mSv [2 mrem] per hour. 

9  Require timely reporting to the NRC, according to 10 CFR 20.2201, “Reports of theft or 

10 loss of licensed material,” 20.2202, “Notification of incidents,” and 20.2203, “Reports of 

11 exposures, radiation levels, and concentrations of radioactive material exceeding the 

12 constraints or limits;” 10 CFR 30.50, “Reporting requirements;” and 10 CFR 21.21, 

13 “Notifications of failure to comply or existence of a defect and its evaluation.” 

The NRC must be notified when a self-shielded irradiator is lost, stolen, or other conditions 

occur. The RSO must be proactive in evaluating whether NRC notification is required. Refer 

to Appendix N and the relevant regulations (10 CFR 20.2201 through 20.2203, 10 CFR 30.50, 

and 10 CFR 21.21) for a description of when and where notifications are required. 

Licensee personnel implement emergency procedures when a flammable sample catches fire. 

Figure 8-6. Proper Handling of Incident 

14 Appendix O of this NUREG provides information for applicants to consider when developing 

15 their procedures for self-shielded irradiators. 

62-pt4-9128-104b.ppt

032498

Proper Handling of Incident

1. Unauthorized sample

irradiated

2. Drive mechanism jams,

starts fire

3. Prohibits use and restricts

access to irradiator area

4. RSO and Fire Department

respond

Survey

Meter

Calls to RSO and 911
8-32 

1 Licensees may change or revise their operating and emergency procedures if: 

2  the changes are reviewed, approved, and documented by licensee management and 

3 the RSO 

4  affected licensee staff is trained in the revised procedures before they are implemented 

5  the changes are consistent with applicable license conditions and the procedures or 

6 commitments submitted in the license application 

7  the changes do not degrade the safety or security of the program 

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things, 

 in accordance with 10 CFR 37.21(a), establish, implement, and maintain its access 

authorization program in accordance with the requirements of 10 CFR Part 37, 

Subpart B; 

 in accordance with 10 CFR 37.45, coordinate with their local law enforcement agency 

(LLEA) for responding to threats to a licensee’s facility; and 

 in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices. 

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 

Please note, under 10 CFR Part 37, security plans are not to be submitted to the NRC, but 

may be subject to review and inspection.

8 Response from Applicant: Submit the following: 

9  A statement that: “If we change our operating, emergency, or security procedures 

10 without amending our license, we will ensure that (i) the changes are reviewed and 

11 approved by licensee management and the RSO; (ii) affected licensee staff are trained 

12 in the procedures before they are implemented; (iii) the changes are consistent with 

13 applicable license conditions and the procedures or commitments submitted in the 

14 license application; and (iv) the changes do not degrade the safety of the program.” 

15 AND EITHER 

16  A statement that: “Operating, emergency, and security procedures will be developed, 

17 implemented, maintained, and distributed and will meet the Criteria in the section entitled 

18 ‘Radiation Safety Program - Operating and Emergency Procedures’ in NUREG-1556, 
8-33 

1 Volume 5, Revision 1, ‘Consolidated Guidance About Materials Licenses: 

2 Program-Specific Guidance About Self-Shielded Irradiator Licenses.’” 

3 OR 

4  alternative operating and emergency procedures 

5 Notes: 

6  Alternative procedures will be reviewed using the criteria listed above. Do not submit 

7 your security procedures. Security procedures will be reviewed during the prelicense 

8 visit and subsequent inspections. 

9  Licenses authorizing J. L. Shepherd Mark I or Model 81-22 irradiators will include license 

10 conditions to require compliance with the terms of the Order in Appendix I of this 

11 NUREG. Applicants requesting these irradiators must ensure that their operating and 

12 emergency procedures address these requirements. 

13 8.10.6.2 Security Program for Category 1 and Category 2 Radioactive Material 

14 Regulations: 10 CFR Part 37 

15 Criteria: Licensees must ensure the security of Category 1 and Category 2 radioactive 

16 material. 

17 Note: The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated 

18 Category 1 or Category 2 quantity of radioactive material. The specific radionuclides subject to 

19 10 CFR Part 37 requirements are listed in Table 1 of Appendix A to 10 CFR Part 37. 

20 Discussion: 

21 Requirements in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities 

22 of Radioactive Material” 

23 In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or 

24 Category 2 quantities of radioactive material must establish, implement, and maintain an access 

25 authorization program (Subpart B) and a security program (Subpart C) to ensure physical 

26 protection of the radioactive material. 

27 Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37, 

28 lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

29 should refer to this table to determine whether its proposed activities would be subject to the 

30 10 CFR Part 37 requirements. 

31 Before giving individuals unescorted access to Category 1 or Category 2 quantities of 

32 radioactive material (as defined in 10 CFR 37.5), licensees must conduct background 

33 investigations of these individuals, to determine that they are trustworthy and reliable, in 

34 accordance with 10 CFR 37.25. 
8-34 

1 In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to 

2 monitor and, without delay, detect, assess, and respond to any actual or attempted 

3 unauthorized access to Category 1 or Category 2 quantities of radioactive material. 

4 Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

5 Category 2 quantities of radioactive materials in transit. These requirements apply to licensees 

6 delivering such material to a carrier for transport, as well as cases in which licensees are 

7 transporting such material. Please note that the Subpart D requirements applicable to the 

8 transport of Category 1 quantities of radioactive material are more stringent than those 

9 applicable to Category 2 quantities. 

Applicants and licensees are required to implement the 10 CFR Part 37 security requirements 

before they take possession of an aggregated Category 1 or Category 2 quantity of radioactive 

material. 

Any licensee that has not previously been made subject to the provisions of 10 CFR Part 37, 

Subpart C shall notify the NRC regional office specified in 10 CFR 30.6 in writing at least 90 

days before aggregating radioactive material to a quantity that equals or exceeds the Category 

2 threshold. Pursuant to 10 CFR 37.43(b), as part of the security program, the licensee must 

develop and maintain written procedures that document how the requirements of Subpart C will 

be met. These written procedures may be subject to NRC review and inspection. 

10 For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, 

11 “Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and Category 

12 2 Quantities of Radioactive Material.”” Additional information regarding best practices for 

13 protection of risk-significant radioactive material is available in NUREG-2166, “Physical Security 

14 Best Practices for the Protection of Risk-Significant Radioactive Material.” 

15 Response from Applicant: 

16 No response is required from an applicant or licensee. Compliance with access authorization 

17 and security program requirements may be reviewed during NRC inspections. 

18 8.10.7 Leak Tests 

19 Regulations: 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.2103 

20 Criteria: The NRC requires testing to determine whether there is any radioactive leakage from 

21 the source in the self-shielded irradiator. The NRC finds testing to be acceptable if it is 

22 conducted by an organization licensed by the NRC or an Agreement State to perform leak 

23 testing or if it is conducted in accordance with procedures submitted by the applicant and 

24 approved by the NRC. Licensees must maintain records of leak test results in accordance with 

25 license conditions or, if applicable, NRC regulations. 

26 Discussion: Based on the conditions of the license, a licensee must leak test sealed sources 

27 at intervals approved by the NRC or as specified in the SSD registration certificate. The 

28 measurement of the leak test sample is a quantitative analysis requiring that instrumentation 

29 used to analyze the sample be capable of detecting 185 Bq [0.005 Ci] of radioactivity. 

30 Manufacturers, distributors, consultants, and other organizations may be authorized by the NRC 

31 or an Agreement State to either perform the entire leak test sequence on behalf of licensees or 
8-35 

1 provide leak test kits to licensees. In the latter case, the licensee takes the leak test sample 

2 according to the manufacturer’s and/or the kit supplier’s instructions and returns it to the leak 

3 test service provider for evaluation and reporting results. Leak test samples should be collected 

4 at the most accessible area where contamination would accumulate if the sealed source were 

5 leaking. The NRC or an Agreement State may, in a license condition, specifically authorize 

6 self-shielded irradiator licensees to conduct the entire leak test sequence themselves. 

7 Response from Applicant: 

8 Submit one of the following: 

9  the statement: “Leak tests will be performed at intervals approved by the NRC or as 

10 specified in the Sealed Source and Device registration certificate. Leak tests will be 

11 performed by an organization authorized by the NRC or an Agreement State to provide 

12 leak testing services to other licensees; or by using a leak test kit supplied by an 

13 organization authorized by the NRC or an Agreement State to provide leak test kits to 

14 other licensees; and according to the self-shielded irradiator manufacturer’s or 

15 distributor’s instructions and kit supplier’s instructions.” 

16 OR 

17  the statement: “Leak testing and analysis will be done by the applicant.” Provide the 

18 information in Appendix P of this NUREG supporting a request to perform leak testing 

19 and sample analysis and either state that you will follow the model procedures in 

20 Appendix P of NUREG-1556, Volume 5, Revision 1, ‘Consolidated Guidance about 

21 Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiators or submit 

22 alternative procedures.” 

23 Notes: 

24  Alternative responses will be reviewed using the criteria listed above. 

25  Requests for authorization to perform leak testing and sample analysis will be reviewed 

26 on a case-by-case basis and, if approved, the NRC staff will authorize these activities 

27 through a license condition. 

28 8.10.8 Maintenance 

29 Regulations: 10 CFR 20.1101, 10 CFR 30.32(g)(2), 10 CFR 30.34(e), 10 CFR 32.210 

30 Criteria: Self-shielded irradiators should be maintained according to the manufacturer’s or 

31 distributor’s written recommendations and instructions and in accordance with the SSD 

32 registration certificate; see Figure 8-7. For self-shielded irradiators, writers of the radiation 

33 safety procedures for maintenance must consider the ALARA criterion and ensure that the 

34 irradiator functions as designed and that source integrity is not compromised. 

35 Discussion: NRC Information Notice 96-35, “Failure of Safety Systems on Self-Shielded 

36 Irradiators Because of Inadequate Maintenance and Training,” dated June 11, 1996, 

37 emphasizes the importance of proper maintenance and describes two incidents in which safety 

38 interlocks on self-shielded irradiators failed to prevent inadvertent exposure. Generally, before 
8-36 

1 any maintenance or repair work is done, licensees need to determine (and assure themselves 

2 of the adequacy of) the following: 

3  the training and experience of the personnel performing the work 

4  the tasks to be performed 

5  the protocol or procedures to be followed (e.g., from the manufacturer’s and/or 

6 distributor’s procedures or instruction manual) for the particular task to be performed 

7  the radiation safety procedures, including any possible need for compensatory 

8 (emergency) measures (such as steps taken to compensate for lack of or 

9 reduced shielding) 

10  considerations for keeping exposures ALARA 

11  the qualification of parts, components, and other materials to be used in the irradiator 

12  use of an operable and calibrated radiation survey meter 

13  the tests to be performed before the irradiator is returned to routine use to ensure that it 

14 functions as designed 

15 The NRC permits self-shielded irradiator licensees to perform routine maintenance of the 

16 irradiator, provided that they follow the self-shielded irradiator manufacturer’s or distributor’s 

17 written recommendations and instructions. 

To ensure proper operation of the unit, self-shielded irradiator licensees need to perform 

routine maintenance according to the manufacturer’s or distributor’s written instructions 

and recommendations. 

Figure 8-7. Routine Maintenance and Lubrication 

62-pt4-9162-103d.ppt

092498

Routine Maintenance and Lubrication

Manufacturer’s or

Distributor’s Written

Directions

Approved Supplies

Training or

Supervison or RSO

Authorization
8-37 

For nonroutine maintenance, most licensees rely on the manufacturer, distributor, or other 

service-provider companies. 

Figure 8-8. Nonroutine Maintenance 

In this NUREG, “routine maintenance” includes cleaning, lubrication, and changing batteries, 

relays, or fuses. 

AND 

“Nonroutine maintenance” means any repair, removal, replacement, or alteration involving 

electrical and mechanical systems that control source or shielding movement, the irradiator’s 

shielding or sealed source, safety interlocks, any component that may affect safe operation of 

the irradiator, or any other activities during which personnel could receive radiation doses 

exceeding NRC limits. 

1 Nonroutine maintenance must be performed by the self-shielded irradiator manufacturer, 

2 distributor, service provider, or a person specifically authorized by the NRC or an Agreement 

3 State; see Figure 8-8. 

4 Applicants seeking authorization to perform nonroutine maintenance should submit specific 

5 operating and emergency procedures to the NRC for review. See Appendix Q of this NUREG 

6 for more information. 

7 Note: When replacement parts are required, and neither the irradiator licensee nor its service 

8 provider can obtain the replacement part from the manufacturer or distributor, the irradiator 

9 licensee and/or service provider may obtain a part from another vendor or fabricate the part. If 

10 the original equipment manufacturer (OEM) part cannot be obtained, the irradiator licensee 

11 and/or the service provider should verify that the replacement part will have the same form, fit, 

12 and function as the original component. If the maintenance involves work on 

13  the shielding of any sealed sources 

14  the driving unit of any sources 

15  safety interlocks 

16 

62-pt4-9128-102c.ppt

092498

Non-Routine Maintenance

survey meter

registering

radiation

Safety Checklist

NRC & RSO

Authorization

Maintenance

Procedures

Survey Meter

Dosimetry

dosimeter
8-38 

1  any other electrical or mechanical component that: 

2 — could expose any sources 

3 — would reduce the shielding around any sources 

4 — could compromise the radiation safety of the device or any sources 

5 The irradiator licensee should provide the technical information to the NRC for a safety review 

6 before nonroutine maintenance activities occur in accordance with the SSD registry, as 

7 described in 10 CFR 32.210 and 10 CFR 30.32(g)(2), to ensure compliance with the radiation 

8 safety measures that apply to the original equipment. 

9 Equipment defects that could create a substantial safety hazard or equipment failures involving 

10 NRC-regulated activities must be reported to the NRC in accordance with 10 CFR Part 21. For 

11 example, a safety interlock failure for an irradiator/calibrator is a defect that must be reported to 

12 the NRC. IN 91-39, “Compliance with 10 CFR Part 21, Reporting of Defects and 

13 Noncompliance,” dated June 17, 1991, provides additional guidance on determining whether a 

14 safety hazard exists and sample procedures for identifying and reporting defects. The 

15 information notice can be found on the NRC’s Generic Communications Web page under 

16 Information Notices at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/. For guidance 

17 on the use of sources that have not been directly supplied by the manufacturer and/or 

18 distributor, see RIS 2013-01, “Use of Aftermarket Sealed Sources Registered Under 

19 10 CFR 32.210” dated March 12, 2013 (ADAMS Accession No. ML12313A147). 

20 The NRC issued RIS 2008-23, “The Global Threat Reduction Initiative (GTRI) Domestic Threat 

21 Reduction Program & Federally Funded Voluntary Security Enhancements for High-Risk 

22 Radiological Material,” on October 3, 2008 (ADAMS Accession No. ML082540256). This 

23 voluntary initiative has been coordinated with the Department of Energy’s National Nuclear 

24 Security Administration (NNSA). Please note that once an irradiator has undergone these 

25 security enhancements (also known as being “hardened”), it is much more difficult to access the 

26 cesium chloride sources, and this could affect servicing (e.g., source exchange, transportation). 

27 Irradiator licensees with GTRI-hardened irradiators should confirm that the service provider 

28 licensee can perform the activity. Licensees should review their NRC or Agreement State 

29 licenses or contact the regulatory agency to confirm that service providers are authorized to 

30 perform the requested hardened-irradiator services. GTRI irradiator hardening was done to 

31 ensure the continued safe use and operation of the irradiator in keeping with the sealed source 

32 and device registration. If a service provider informs the irradiator licensee that they will remove 

33 any aspect of the GTRI irradiator-hardening hardware, the irradiator licensee should discuss this 

34 matter with its regulatory agency before allowing the service provider to initiate this service. 

35 Response from Applicant: 

36 For all maintenance, submit: 

37  this statement: “We will maintain documentation of the use of all non-OEM replacement 

38 parts and components. If OEM replacement parts cannot be used for the shielding of 

39 any sealed sources, the driving unit of any sources, safety interlocks, or other electrical 

40 or mechanical component that could expose the source, reduce the shielding around the 

41 source(s), or compromise the radiation safety of the device or any sources, we will 

42 obtain and document NRC approval before beginning the nonroutine maintenance 

43 activity. In addition, if a service provider plans to remove any aspect of the GTRI 
8-39 

1 irradiator-hardening hardware, we will discuss this matter with the NRC before allowing 

2 this service to be initiated.” 

3 For routine maintenance, submit either of the following: 

4  this statement: “We will implement and maintain procedures for routine maintenance of 

5 our self-shielded irradiators according to each manufacturer’s or distributor’s written 

6 recommendations and instructions.” 

7 OR 

8  alternative procedures for the NRC’s review 

9 For nonroutine maintenance, submit either of the following: 

10  this statement: “We will have the self-shielded irradiator manufacturer, distributor, 

11 service provider, or another person authorized by the NRC or an Agreement State 

12 perform nonroutine maintenance.” 

13 OR 

14  alternative procedures for the NRC’s review addressing the information listed in 

15 Appendix Q of NUREG-1556, Volume 5, Revision 1, ‘Consolidated Guidance About 

16 Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator 

17 Licenses.’” 

18 Notes: 

19  Alternative procedures for performing routine maintenance will be reviewed using the 

20 criteria listed above. 

21  Information requested in Appendix Q will be reviewed on a case-by-case basis. If 

22 approved, the license will contain a condition authorizing the licensee to perform 

23 nonroutine maintenance. 

24 References: IN 91-39, “Compliance with 10 CFR Part 21, Reporting of Defects and 

25 Noncompliance,” dated June 17, 1991, can be found on the NRC’s Generic Communications 

26 Web page under Information Notices at http://www.nrc.gov/reading-rm/doc-collections/gen27 comm/. 

28 RIS 2013-01, “Use of Aftermarket Sealed Sources Registered under 10 CFR 32.210,” issued 

29 March 12, 2013 (ADAMS Accession No. ML12313A147). 

30 8.10.9 Transfer and Transportation 

31 Regulations: 10 CFR 20.1101, 10 CFR 30.41, 10 CFR 30.51, 10 CFR Part 37 (Subpart D), 

32 10 CFR 71.5, 10 CFR 71.12, 10 CFR 71.37, 10 CFR 71.38, 10 CFR 71.101, 10 CFR 110.23, 

33 10 CFR 110.27, 10 CFR 110.28, 10 CFR 110.29, and 49 CFR Parts 171-178 

34 Criteria: Licensees and applicants must develop, implement, and maintain procedures for 

35 transport of radioactive material to ensure compliance with NRC and U.S. Department of 
8-40 

1 Transportation (DOT) regulations. In accordance with 10 CFR Part 37 (Subpart D), licensees 

2 must also preplan, coordinate and provide advance notification of the shipment of Category 1 

3 quantities of radioactive material and coordinate the shipment of Category 2 quantities of 

4 radioactive material. 

5 Discussion: All packages containing radioactive sources must be prepared and shipped 

6 according to NRC and DOT regulations. 

7 Some irradiator licensees who rarely ship radioactive material have chosen to transfer 

8 possession of radioactive materials to a contracted irradiator manufacturer, irradiator distributor, 

9 or service provider licensee (contractor) with an NRC or Agreement State license who then acts 

10 as the shipper. The contractor, who is subject to the provisions of 10 CFR 71.12 or 

11 10 CFR 71.14, as appropriate, then becomes responsible for proper packaging of the 

12 radioactive materials and compliance with NRC and DOT regulations. Licensees who do this 

13 should ensure that the contractor 

14  is authorized to possess the irradiator at temporary jobsites (e.g., at the irradiator 

15 location) 

16  actually takes possession of the irradiator under its license 

17  provides documentation of the transfer of possession to the licensee 

18  uses an approved Type B package 

19  is registered with NRC as a user of the Type B package 

20  has an NRC-approved QA plan 

For each shipment, it must be clear (i) when the transfer of possession from the licensee to 

the contractor takes place, (ii) who possesses the licensed material and is responsible for 

proper packaging of the radioactive materials and compliance with NRC and DOT regulations, 

(iii) who is responsible for security of the radioactive materials, and (iv) who is responsible for 

decontamination and cleanup, if necessary. 

21 During an inspection, the NRC uses the provisions of 10 CFR 71.5, “Transportation of licensed 

22 material,” and a Memorandum of Understanding (MOU) with DOT on the Transportation of 

23 Radioactive Material (signed June 6, 1979) to examine and enforce various DOT requirements 

24 applicable to irradiator licensees. Appendix R of this NUREG lists major DOT regulations. 

25 For secure transport of radioactive material quantities of concern, the shipper (either the 

26 licensee or the service provider, as appropriate) must comply with the security measures 

27 described in Subpart D of 10 CFR Part 37. Additional information regarding secure transport 

28 can be found in Section 8.10.6.2, “Security Program for Category 1 and Category 2 Radioactive 

29 Material,” of this NUREG. 

30 If the irradiator to be moved or transported has been hardened, as described in the 

31 Maintenance Section above, the irradiator may be transported in an approved Type B shipping 

32 cask in its entirety. If the licensee or service provider wishes to remove the hardening for 

33 
8-41 

1 transport, the licensee should discuss this matter with the NRC before allowing this service to 

2 be initiated. 

Figure 8-9. Illustrations for Import and Export 

Note: If the sealed source(s) will be procured from a company outside the U.S., the NRC 

licensee must comply with the import regulations listed in 10 CFR Part 110. The same applies 

for exports of byproduct material, as illustrated in Figure 8-9. Also be aware of the list of 

embargoed and restricted destinations.

3 Irradiators Built Before 10 CFR Part 71 Regulation Implementation/Exemption Request 

4 Before the adoption of the requirements of 10 CFR Part 71 in 1966, irradiators could be 

5 transported without being evaluated under the hypothetical accident conditions now 

6 incorporated in 10 CFR Part 71. Unlike most post-1966 irradiators, pre-1966 irradiators are not 

7 certified shipping packages. Transport of pre-1966 units may require transferring the sealed 

8 source from the irradiator to a Type B package or the use of a certified package for the irradiator 

9 containing the sealed sources. NRC will consider a licensee’s request for an exemption for a 

10 one-time shipment, according to 10 CFR 71.12, only if the options above are not viable. 

11 An exemption may be granted if the request is authorized by law and will not endanger life or 

12 property or the common defense and security. A request for such an exemption should 

13 demonstrate the need for the exemption, describe why alternatives considered are not viable, 

14 specify from what requirement(s) an exemption is requested and the period for which the 

15 exemption is requested, and describe steps taken to ensure that the shipment will not endanger 

16 life or property or the common defense and security (for example, steps to minimize accident 

17 risk and to respond to a transportation accident). Typically, exemption requests that the NRC 

18 approves are for a limited period, such as 30 days. 

19 Additional information supporting an exemption request should include the following: 

20  the manufacturer’s or distributor’s name and the model number of the irradiator, the type 

21 and activity of radioactive material to be transported, and a brief description of the 

22 proposed trip (including at least its starting and ending points and approximate distance) 

23  the planned date of the shipment 

24  engineering drawings of the irradiator 

25  consideration of the following: 
8-42 

1 — DOT’s hazardous material routing requirements 

2 — transport during time of low road usage 

3 — use of good roads and avoidance of residential areas to the maximum 

4 extent possible 

5 — accompaniment of the shipment by an escort knowledgeable in the use of 

6 radiation survey instruments 

7 — providing the escort with appropriate survey instruments and supplies to permit 

8 the establishment of a radiation exclusion area 

9 — written procedures to be followed by the escort in an emergency situation 

10 — use of an exclusive-use vehicle and shoring to limit movement of the package 

11 during transport 

12 — notification of state radiological health officials and the local fire department of 

13 the time and route of the shipment 

14 — how the material will be secured to meet the requirements of Subpart D of 

15 10 CFR Part 37 

16 NRC Headquarters staff must review these exemption requests, which are typically requests to 

17 amend materials (10 CFR Part 30) licenses. Licensees should address their requests to the 

18 appropriate Regional Office. The Regional Office will refer the request to NRC Headquarters 

19 staff for review by NMSS. If the exemption is approved, NRC Headquarters staff will provide the 

20 language for the license condition. There may be an additional fee associated with these 

21 special reviews. In addition to an NRC exemption, the licensee may also need a DOT 

22 exemption; contact DOT’s Office of Hazardous Materials Safety at 202-366-4535 for additional 

23 information. 

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

25 However, before offering a Type B package for shipment, a licensee needs to have registered 

26 with the NRC as a user of the package and obtained NRC’s approval of its QA program. 

27 Transportation issues will be reviewed during inspection. 

Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive 

material are subject to the 10 CFR Part 37, Subpart D (“Physical Protection in Transit’). For 

additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best 

practices for protection of risk-significant radioactive material is available in NUREG–2166, 

“Physical Security Best Practices for the Protection of Risk-Significant Radioactive 

Material.” 

Please note, under 10 CFR Part 37, security plans are not to be submitted to the NRC, 

but may be subject to review and inspection.
8-43 

1 To request an exemption from the regulations for the transportation of an irradiator built before 

2 1966, submit the following: 

3  Establish that the irradiator was built before 1966. 

4  Explain why an approved package cannot be used, what alternatives have been 

5 considered, and why each alternative is not viable. 

6  Specify from what requirement(s) an exemption is requested and the period for which 

7 the exemption is requested. 

8  Describe procedures, controls, and other actions to be taken to ensure that the shipment 

9 will not endanger life or property or the common defense and security. 

10  Demonstrate that the request is authorized by law and will not endanger life or property 

11 or the common defense and security. 

12 References: “A Review of Department of Transportation Regulations for Transportation of 

13 Radioactive Materials” can be obtained by calling DOT’s Office of Hazardous Material Initiatives 

14 and Training at 202-366-4425. 

15 8.11 Item 11: Waste Management 

16 8.11.1 Self-Shielded Irradiator Transfer and Disposal 

17 Regulations: 10 CFR 20.2001, 10 CFR 20.2207, 10 CFR 30.41, 10 CFR 30.51 

18 Criteria: Licensed materials must be disposed of according to NRC requirements by transfer to 

19 an authorized recipient in accordance with 10 CFR 30.41, “Transfer of byproduct material.” 

20 Appropriate records must be maintained in accordance with 10 CFR 30.51. 

21 The NRC’s Lost Source Policy states that a civil penalty may be issued for violations resulting in 

22 regulated material being out of the control of the licensee, regardless of the use, license type, 

23 quantity, or type of regulated material (e.g., through loss, abandonment, improper transfer, or 

24 improper disposal of regulated material). The Lost Source Policy is described in Section 2.3.4 

25 of NRC’s Enforcement Policy and in Section 3.1 in NRC’s Enforcement Manual. 

26 Discussion: Before transferring radioactive material, a licensee must verify that the recipient is 

27 properly authorized to receive it using one of the methods described in 10 CFR 30.41. In 

28 addition, under 10 CFR 37.71(a) and (b), “Physical Protection of Byproduct Material Category 1 

29 and Category 2 Quantities of Radioactive Material,” any licensee, before transferring Category 1 

30 or Category 2 quantities of radioactive material, shall verify that the recipient is authorized to 

31 possess the radioactive material. This verification can be completed in one of two ways: 

32  using the NRC’s License Verification System (LVS) 

33 OR 

34  contacting the license-issuing authority 
8-44 

1 In either case, the licensee must verify that the transferee’s license authorizes the receipt of the 

2 type, form, and quantity of radioactive material to be transferred and that the licensee is 

3 authorized to receive radioactive material at the location requested for delivery. If the 

4 verification is conducted by contacting the license-issuing authority, the transferor shall 

5 document the verification. For transfers within the same organization, the licensee does not 

6 need to verify the transfer. 

7 When the licensee is unable to use the LVS to complete the license verification requirement, 

8 they may use a manual process to verify the license with the regulatory agency that issued the 

9 license. Verification information is collected from both the transferring licensee and the issuing 

10 agency using NRC Form 749, “Manual License Verification Report.” Information about LVS can 

11 be found on the NRC Web page under Nuclear Security and Safeguards/Radioactive Material 

12 Security at http://www.nrc.gov/security/byproduct/ismp/lvs.html. 

13 When disposing of self-shielded irradiators, licensees must transfer them to an authorized 

14 recipient. Authorized recipients are the original manufacturer or distributor of the irradiator, 

15 a commercial firm licensed by the NRC or an Agreement State to accept radioactive waste from 

16 other persons, or another specific licensee authorized by NRC or an Agreement State to 

17 possess the licensed material (i.e., its license specifically authorizes the same radionuclide, 

18 form, and use). Licensees should promptly dispose of irradiators that are no longer in service or 

19 not being used by the licensee in order to minimize potential problems of access by 

20 unauthorized individuals, use for inappropriate purposes, or improper disposal. Because of the 

21 difficulties and costs associated with disposal of sealed sources, applicants should preplan the 

22 disposal. Applicants might want to consider contractual arrangements with the source supplier 

23 as part of a purchase agreement. 

24 If source activity exceeds activities listed in Appendix E, “Nationally Tracked Source 

25 Thresholds,” to 10 CFR Part 20, the transfer transaction must be reported in accordance with 

26 10 CFR 20.2207. 

The Conference of Radiation Control Program Directors (CRCPD) maintains a list of “Outlets for 

Common Radioactive Materials” and “Radioactive Waste Broker & Decontamination Services” 

on their Web site at http://www.crcpd.org/StateServices/Comm_Svcs.aspx.

27 Appendix S of this NUREG contains helpful information related to the Radiation Source Use and 

28 Replacement Study, which can also be found on the NRC Web page under Nuclear Security 

29 and Safeguards/Radioactive Material Security at http://www.nrc.gov/security/nas-facts30 sheet.pdf. 

 

31 Response from Applicant: The applicant does not need to provide a response to this item 

32 during the licensing phase. However, the licensee should develop, implement, and maintain 

33 self-shielded irradiator transfer and waste disposal procedures, including updates to the NSTS, 

34 in its radiation safety program. 

35 References: 

36 The NRC’s Enforcement Policy may be found online at 

37 http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html, and the Enforcement 

38 Manual may be found online at 

39 http://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. 
8-45 

1 8.12 Item 12: License Fees 

2 On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of 

3 the fee enclosed with the application. 

4 Direct all questions about the NRC’s fees or the completion of Item 12 of NRC Form 313 

5 to the Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, 301-

6 415-7554. Information about fees may also be obtained by calling the NRC’s toll-free number, 

7 800-368-5642, extension 415-7554. The e-mail address for fees questions is 

8 Fees.Resource@nrc.gov. 

9 8.13 Item 13: Certification 

10 A representative of the corporation or legal entity filing the application should sign and date 

11 NRC Form 313. The representative signing the application must be authorized to make binding 

12 commitments and to sign official documents on behalf of the applicant. As discussed previously 

13 in Chapter 3, “Management Responsibility,” signing the application acknowledges 

14 management’s commitment to and responsibility for the radiation protection program. The NRC 

15 will return all unsigned applications for proper signature. 

16 Notes: 

17  It is a criminal offense to knowingly and willfully make a false statement or 

18 representation on applications or correspondence (18 U.S.C. 1001). 

19  When the application references commitments, those items will be incorporated into the 

20 license and, therefore, will become binding regulatory requirements. 

9-1 

1 9 LICENSE AMENDMENTS AND RENEWALS 

2 It is the licensee’s obligation to keep the license current. If any of the information provided in 

3 the original application is to be modified or will change, the licensee must submit an application 

4 for a license amendment before the change takes place. The change is not in effect until the 

5 amendment has been issued. Also, to continue the license after its expiration date, the licensee 

6 must submit an application for a license renewal at least 30 days before the expiration date 

7 Title 10 of the Code of Federal Register (CFR) [10 CFR 2.109(a), 10 CFR 30.36(a)]. 

8 Applicants for license amendment or renewal should do the following: 

9  Use the most recent guidance in preparing an amendment or renewal request. 

10  Submit either an U.S. Nuclear Regulatory Commission (NRC) Form 313 or a letter 

11 requesting amendment or renewal. 

12  Provide the license number and docket number. 

13  For renewals, provide a complete and up-to-date application, including all required 

14 program elements outlined in Appendix B of this NUREG. Training documentation for 

15 personnel currently listed on the license does not need to be submitted as part of the 

16 renewal application. 

17 9.1 Timely Notification of Transfer of Control 

18 Regulation: 10 CFR 30.34(b) 

19 Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

20 consent before transferring control of the license, also referred to as “change of ownership” 

21 and/or “transferring the license.” 

22 Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

23 transfers. Although it is not the NRC’s intent to interfere with the business decisions of 

24 licensees, under 10 CFR 30.34(b) and the Atomic Energy Act, licensees must obtain prior NRC 

25 written consent before transferring control of the license to ensure the following: 

26  radioactive materials are possessed, used, or controlled only by persons who have valid 

27 NRC or Agreement State licenses 

28  materials are properly handled and secured 

29  persons using these materials are capable, competent and committed to implementing 

30 appropriate radiological controls 

31  a clear chain of custody is established to identify who is responsible for disposition of 

32 records and licensed material 

33  public health and safety are not compromised by the use of such materials 

34  adequate financial assurance is provided for compliance with the applicable NRC 

35 requirements, if required 
9-2 

1 Response from Applicant: No response is required from an applicant for a new license. 

2 However, current licensees should refer to NUREG–1556, Volume 15, “Consolidated Guidance 

3 About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving 

4 Byproduct, Source, or Special Nuclear Materials Licenses,” for more information about transfer 

5 of control (i.e., ownership). 

6 Reference: For further information, see Regulatory Issue Summary (RIS) 2014-08, Rev. 1, 

7 “Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials 

8 Licenses,” dated May 5, 2016. This RIS can be found on the NRC’s Generic Communications 

9 Web page under “Regulatory Issue Summaries”: 

10 http://www.nrc.gov/reading-rm/doc-collections/gen-comm/.
10-1 

1 10 APPLICATIONS FOR EXEMPTIONS 

2 Regulations: 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11 

3 Criteria: Licensees may request exemptions from U.S. Nuclear Regulatory Commission (NRC) 

4 regulations. The licensee must demonstrate that the exemption is authorized by law; will not 

5 endanger life, property, or the common defense and security; and is otherwise in the public 

6 interest. Licensees may also use existing specific exemptions outlined in the 10 CFR 

7 regulations if they meet the established criteria. 

8 Discussion: Various sections of the NRC’s regulations address requests for exemptions 

9 (e.g., 10 CFR 19.31, “Application for exemptions;” 10 CFR 20.2301, “Applications for 

10 exemptions;” 10 CFR 30.11, “Specific exemptions”). These regulations state that the NRC may 

11 grant an exemption, acting on its own initiative or on an application from an interested person. 

12 Exemptions are not intended to revise regulations or apply to large classes of licensees and are 

13 generally limited to unique situations. Requests for exemptions submitted to the NRC must 

14 identify the regulation for which the exemption is being requested and include a justification for 

15 the requested exemption. 

Unless the NRC has granted an exemption in writing, licensees must comply with all 

applicable regulations. 

16 Some licensees with self-shielded irradiators built before 1966 may need an exemption from the 

17 requirements in 10 CFR Part 71 in order to transport these irradiators. Section 8.10.9, 

18 “Transportation,” provides more detailed information about this special situation. 

11-1 

1 11 TERMINATION OF ACTIVITIES 

2 Regulations: 10 CFR 20.1401, 10 CFR 20.1402, 10 CFR 20.1403, 10 CFR 20.1404, 

3 10 CFR 20.1405, 10 CFR 20.1406, 10 CFR 30.34(b), 10 CFR 30.35(g), 10 CFR 30.36, 

4 10 CFR 30.36(d), 10 CFR 30.36(g), 10 CFR 30.36(h), 10 CFR 30.36(j), 10 CFR 30.51(f) 

5 Criteria: The licensee must do the following: 

6  Notify the U.S. Nuclear Regulatory Commission (NRC), in writing, within 60 days of the 

7 occurrence of any of the following: 

8 — expiration of its license 

— a decision to permanently cease principal activities1 9 at the entire site 

— a decision to permanently cease principal activities1 10 in any separate building or 

11 outdoor area that contains residual radioactivity such that the building or area is 

12 unsuitable for release according to NRC requirements 

— no principal activities1 13 under the license have been conducted for a period of 

14 24 months 

— no principal activities1 15 have been conducted for a period of 24 months in any 

16 separate building or outdoor area that contains residual radioactivity such that 

17 the building or area is unsuitable for release according to NRC requirements 

18  submit a decommissioning plan, if required by 10 CFR 30.36(g) 

19  conduct decommissioning, as required by 10 CFR 30.36(h) and (j) 

20  submit, to the appropriate NRC regional office, a completed NRC Form 314, “Certificate 

21 of Disposition of Materials” (or equivalent information) and information demonstrating 

22 that the premises are suitable for release for unrestricted use (e.g., results of final 

23 surveys and results of leak tests of sealed sources). 

24  Before a license is terminated, send records important to decommissioning that are 

25 required by 10 CFR 30.35(g) to the appropriate NRC regional office in accordance with 

26 10 CFR 30.51(f). 

 

 

1

Principal activities’ are activities that are essential to achieving the purpose(s) for which the license was issued or 

amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to 

decontamination or decommissioning are not principal activities. 
11-2 

1 Discussion: Typically, a self-shielded irradiator termination request will meet the previously 

2 listed criteria if the licensee has performed the following steps: 

3  The licensee must dispose of or transfer the sealed sources to an NRC or Agreement 

4 State licensee authorized to possess these devices, as described in Section 8.11, 

5 “Waste Management.” 

6  The licensee must copy applicable decommissioning records as described in Section 

7 8.5.2, “Financial Assurance and Recordkeeping for Decommissioning.” Typically, this 

8 includes transfer of records and final leak test records to the appropriate NRC regional 

9 office. See Section 8.5.2 for additional recordkeeping requirements if leaking sealed 

10 sources or other incidents that involve the spreading of contamination have occurred. 

11  The licensee must submit a completed NRC Form 314 and a copy of the applicable 

12 decommissioning records to the appropriate NRC regional office. 

13 Response from Applicant: The applicant is not required to submit a response to the NRC 

14 during the initial application. The licensee’s obligations in this matter begin when the license 

15 expires or at the time the licensee ceases operations, whichever is earlier. These obligations 

16 are to undertake the necessary decommissioning activities, to submit NRC Form 314 or 

17 equivalent information, and to perform any other actions summarized in the previously listed 

18 “Criteria.” 

19 References: 

20 NRC Form 314 is available at http://www.nrc.gov/reading-rm/doc-collections/forms. 

21 NUREG-1757, “Consolidated Decommissioning Guidance,” Volume 1, “Decommissioning 

22 Process for Materials Licensees,” can be found at http://www.nrc.gov/reading-rm/doc23 collections/nuregs/staff/sr1757/. 

24 For information about requirements that apply to the timeliness of decommissioning, see 

25 Regulatory Issue Summary (RIS) 2015-19, Rev. 1, “Decommissioning Timeliness Rule 

26 Implementation and Associated Regulatory Relief,” dated September 27, 2016, which can be 

27 found on the NRC’s Generic Communications Web page under “Regulatory Issue Summaries”: 

28 http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2015/. 
1 APPENDIX A 

2 

3 U.S. NUCLEAR REGULATORY COMMISSION FORM 313 

A–1 

U.S. Nuclear Regulatory Commission Form 313 

Please use the most current version of this form, which may be found at: 

http://www.nrc.gov/reading-rm/doc-collections/forms/

1 APPENDIX B 

2 SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

3 ITEMS 5 THROUGH 11 OF NRC FORM 313 

B–1 

1 Suggested Format for Providing Information Requested 

2 in Items 5 Through 11 of NRC Form 313 

Table B–1. Items 5 & 6: Materials to Be Possessed and Proposed Uses 

Yes No Radioisotope 

Manufacturer 

or Distributor 

Model No. Quantity 

Use as Listed 

on SSD 

Registration 

Certificate 

Specify Other 

Uses Not Listed 

on SSD 

Registration 

Certificate 

Cesium-137 Each of the 

following 

requested 

sealed sources, 

devices, and 

source/device 

combinations is 

the subject of an 

approved SSD 

registration 

certificate 

number(s). 

State the SSD 

certificate 

number(s): 

____________ 

Sealed source 

manufacturer’s 

or distributor’s 

name and model 

number: 

 

Device 

manufacturer’s 

or distributor’s 

name and model 

number: 

 

_________Ci 

per source and 

maximum 

possession limit 

(based on 

number of 

sources 

requested): 

_______ Ci total

Not to exceed 

either the 

maximum 

activity per 

source or 

maximum 

activity per 

device as 

specified in SSD

registration 

certificate 

Yes [ ] [ ] Not 

applicable 

 

[ ] Uses are: 

 

(Submit safety 

analysis, 

including 

procedures and 

training, 

supporting safe 

use) 

 
B–2 

Table B–1. Items 5 & 6: Materials to Be Possessed and Proposed Uses (Continued) 

Yes No Radioisotope 

Manufacturer 

or Distributor 

Model No. Quantity 

Use as Listed 

on SSD 

Registration 

Certificate 

Specify Other 

Uses Not Listed 

on SSD 

Registration 

Certificate 

Cobalt-60 Each of the 

following 

requested 

sealed sources, 

devices, and 

source/device 

combinations is 

the subject of an 

approved SSD 

Registration 

Certificate 

numbers. State 

the SSD 

certificate 

number(s): 

____________ 

Sealed source 

manufacturer’s 

or distributor’s 

name and model 

number: 

 

Device 

manufacturer’s 

or distributor’s 

name and model 

number: 

 

_________Ci 

per source and 

maximum 

possession limit 

(based on 

number of 

sources 

requested): 

_______ Ci total

Not to exceed 

either the 

maximum 

activity per 

source or 

maximum 

activity per 

device as 

specified in SSD

registration 

certificate 

Yes [ ] [ ] Not applicable

 

[ ] Uses are: 

 

(Submit safety 

analysis, 

including 

procedures and 

training, 

supporting safe 

use) 
B–3 

Table B–1. Items 5 & 6: Materials to Be Possessed and Proposed Uses (Continued) 

Yes No Radioisotope 

Manufacturer 

or Distributor 

Model No. Quantity 

Use as Listed 

on SSD 

Registration 

Certificate 

Specify Other 

Uses Not Listed 

on SSD 

Registration 

Certificate 

 Strontium-90 Each of the 

following 

requested 

sealed sources, 

devices, and 

source/device 

combinations is 

the subject of an 

approved SSD 

Registration 

Certificate 

numbers. State 

the SSD 

certificate 

number(s): 

____________ 

Sealed source 

manufacturer’s 

or distributor’s 

name and model 

number: 

 

Device 

manufacturer’s 

or distributor’s 

name and model 

number: 

 

_________Ci 

per source and 

maximum 

possession limit 

(based on 

number of 

sources 

requested): 

_______ Ci total

Not to exceed 

either the 

maximum 

activity per 

source or 

maximum 

activity per 

device as 

specified in SSD

registration 

certificate 

Yes [ ] [ ] Not 

applicable 

 

[ ] Uses are: 

 

(Submit safety 

analysis, 

including 

procedures and 

training, 

supporting safe 

use) 
B–4 

Table B–1. Items 5 & 6: Materials to Be Possessed and Proposed Uses (Continued) 

Yes No Radioisotope 

Manufacturer 

or Distributor 

Model No. Quantity 

Use as Listed 

on SSD 

Registration 

Certificate 

Specify Other 

Uses Not Listed 

on SSD 

Registration 

Certificate 

 Other 

(specify) 

Sealed source 

manufacturer or 

distributor name 

and model 

number: 

 

Device 

manufacturer or 

distributor name 

and model 

number: 

 

SSD 

Registration 

Certificate 

numbers: 

___________ 

_________Ci 

per source and 

maximum 

possession limit 

(based on 

number of 

sources 

requested): 

_______ Ci total

Not to exceed 

either the 

maximum 

activity per 

source or 

maximum 

activity per 

device as 

specified in SSD

registration 

certificate 

Yes [ ] [ ] Not applicable

 

[ ] Uses are: 

 

(Submit safety 

analysis, 

including 

procedures and 

training, 

supporting safe 

use) 

 Yes Description 

Attached 

Financial Assurance and Recordkeeping For 

Decommissioning State the following: “In accordance 

with 10 CFR 30.35(g), we shall maintain drawings and 

records important to decommissioning and shall transfer 

these records to an NRC or Agreement State licensee 

before licensed activities are transferred or forward the 

records to the appropriate NRC regional office before the 

license is terminated.” 

AND 

If financial assurance is required, submit evidence of 

financial assurance following the guidance of NUREG-1757, 

Volume 3, “Consolidated Decommissioning 

Guidance - Financial Assurance, Recordkeeping, and 

Timeliness.” 

[ ]

[ ]
B–5 

Table B–1. Items 5 & 6: Materials to Be Possessed and Proposed Uses (Continued) 

Yes No Radioisotope 

Manufacturer 

or Distributor 

Model No. Quantity 

Use as Listed 

on SSD 

Registration 

Certificate 

Specify Other 

Uses Not Listed 

on SSD 

Registration 

Certificate 

Purpose for Which Licensed Material Will Be Used 

State the following: “We will not irradiate flammable, 

corrosive, or explosive materials.” 

AND 

For all self-shielded irradiators that will be used for the 

purposes listed on the SSD registration certificate, state the 

following: 

If there is only a single irradiator, state: “This self-shielded 

irradiator will be used for the purposes described in its SSD 

registration certificate.” 

OR 

If there are multiple irradiators, state: “These self-shielded 

irradiators will be used for the purposes described in their 

respective SSD registration certificates.” 

OR 

For all self-shielded irradiators that will be used for purposes 

other than those listed on the SSD registration certificate, 

specify these purposes and submit safety analyses, 

including operating and emergency procedures and training, 

as necessary, to support safe use. The safety analyses 

should include enough information to demonstrate that 

irradiation of the proposed items will not compromise the 

integrity of the source, source shielding, or other 

components critical to the radiation safety of the device. 

[ ]

[ ]

[ ]

[ ]

 
B–6 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal 

Item No. and Title Suggested Response Yes 

Alternative 

Procedures 

Attached 

7. Individual(s) 

Responsible for 

Radiation Safety 

Program and 

Their Training 

and Experience 

7.1 Radiation Safety 

Officer (RSO) 

 Name of RSO: 

________________ 

(As you would like it to 

appear on the license) 

State the following: “Before obtaining 

licensed materials, the proposed RSO will 

have successfully completed training 

described in Appendix F of NUREG-1556, 

Volume 5, Revision 1, ‘Consolidated 

Guidance About Materials License: 

Program-Specific Guidance About SelfShielded Irradiator Licenses.” 

OR 

Provide alternative information 

demonstrating that the proposed RSO is 

qualified by training and experience. 

[ ]

[ ]

7. Individual(s) 

Responsible for 

Radiation Safety 

Program and 

Their Training 

and Experience 

7.2 Authorized 

Users (AUs) 

 Names of AUs: 

__________________

__________________

__________________

__________________

__________________ 

(As you would like 

them to appear on the 

license) 

State the following: “Before using 

licensed materials, authorized users will 

receive the training described in 

Appendix F of NUREG-1556, Volume 5, 

Revision 1, ‘Consolidated Guidance About 

Materials License: Program-Specific 

Guidance About Self-Shielded Irradiator 

Licenses.” 

OR

Provide alternative information 

demonstrating that the proposed AUs are 

qualified by training and experience. 

[ ]

[ ]
B–7 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title

Suggested Response 

Yes

8. Training for 

Individuals 

Working in or 

Frequenting 

Restricted Areas 

The applicant’s training program will be 

examined during inspections but should 

not be submitted in the license application.

Need Not Be Submitted 

with Application

9. Facilities and 

Equipment 

State the following: “We will conduct 

electrical and mechanical safety interlock 

checks of each irradiator at least quarterly, 

in accordance with the irradiator’s user’s 

manual.” 

AND EITHER 

State the following: “We will ensure that 

each area where a self-shielded irradiator 

is located corresponds to the ‘Conditions 

of Normal Use’ and ‘Limitations and/or 

Other Considerations of Use’ on the 

applicable irradiator’s Sealed Source and 

Device registration certificate; the floor 

beneath the self-shielded irradiator is 

adequate to support the weight of the 

irradiator; each self-shielded irradiator is 

secured to prevent unauthorized access 

or removal; and each area where a 

self-shielded irradiator is located is 

equipped with an automatically operated 

fire-detection and -control system 

(sprinkler, chemical, or gas) or the location 

of the area and other controls ensure a 

low level of radiation risk attributable to 

fires.” 

OR 

Provide alternative information; be sure to 

include justification for placing an 

irradiator in an area that does not 

correspond to the “Conditions of Normal 

Use” and the “Limitations and/or Other 

Considerations of Use.” 

[ ]

[ ]

[ ]
B–8 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title

Suggested Response 

Yes

10. Radiation Safety 

Program 

10.1 Audit and Review 

of Program 

10.2 Radiation 

Monitoring 

Instruments 

The applicant’s program for reviewing the 

content and implementation of its radiation 

protection program, access authorization 

program, and security program will be 

examined during inspections and should 

not be submitted with the license 

application. 

Submit one of the following: 

 this statement: “We will use 

instruments that meet the 

radiation-monitoring instrument 

specifications published in Appendix K 

of NUREG-1556, Volume 5, Revision 

1, ‘Consolidated Guidance About 

Materials License: Program-Specific 

Guidance About Self-Shielded 

Irradiator Licenses.” Additionally, each 

radiation survey meter will have been 

calibrated by the manufacturer or other 

person authorized by the NRC or an 

Agreement State to perform radiation 

survey meter calibrations no more than 

12 months before the date the meter is 

used.” 

Need Not Be Submitted 

with Application 

[ ]
B–9 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title

Suggested Response 

Yes

OR 

 this statement: “We will use 

instruments that meet the 

radiation-monitoring instrument 

specifications published in Appendix K 

of NUREG-1556, Volume 5, Revision 

1, ‘Consolidated Guidance About 

Materials License: Program-Specific 

Guidance About Self-Shielded 

Irradiator Licenses.” Additionally, we 

will implement the model radiation 

survey meter calibration program 

published in Appendix K of this 

NUREG-1556, and we will ensure that 

each radiation survey meter will have 

been calibrated no more than 

12 months before the date the meter is 

used.” 

OR 

a description of alternative equipment 

and/or procedures for (1) ensuring that 

interlocks function as required to return 

moving self-shielded irradiator sources to 

the shielded position, and (2) determining 

source shielding integrity after an incident 

involving the self-shielded irradiator.

[ ]

[ ]

 
B–10 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title Suggested Response Yes

Alternative 

Procedures 

Attached

10. Radiation Safety 

Program 

10.3 Material Receipt 

and 

Accountability 

10.3.1 Inventory 

10.3.2 National 

Source Tracking 

System (NSTS) 

10.4 Occupational 

Dose 

 

State the following: “We will develop, 

implement, and maintain procedures for 

ensuring accountability of licensed 

materials at all times.” 

State the following: “Physical 

inventories will be conducted and 

documented at intervals not to exceed 

6 months to account for all sealed sources 

and devices received and possessed 

under the license.” 

AND

State the following: “We will comply with 

the NSTS reporting requirement as 

described in 10 CFR 20.2207.” 

Provide any one of the following: 

 the statement: “We will maintain, for 

inspection by the NRC, documentation 

demonstrating that unmonitored 

individuals are not likely to receive a 

radiation dose in excess of the limits in 

10 CFR 20.1502(a).” 

OR 

 the statement: “We will provide and 

require the use of individual monitoring 

devices (dosimetry). All personnel 

dosimeters that require processing to 

determine the radiation dose will be 

processed by a NVLAP-approved 

processor.” 

[ ] 

[ ] 

[ ]

[ ]

[ ]
B–11 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title Suggested Response Yes

Alternative 

Procedures 

Attached

10. Radiation Safety 

Program 

10.5 Public Dose 

10.6 Operating, 

Emergency, and 

Security Procedures 

OR 

a description of an alternative method for 

demonstrating compliance with the 

referenced regulations. 

No response is required from the applicant 

in a license application, but documentation 

demonstrating compliance will be 

examined during inspection. 

Submit the following: 

 this statement: “If we change our 

operating, emergency, or security 

procedures without amending our 

license, we will ensure that (i) the 

changes are reviewed and approved 

by licensee management and the 

RSO; (ii) affected licensee staff are 

trained in the procedures before they 

are implemented; (iii) the changes are 

consistent with applicable license 

conditions and the procedures or 

commitments submitted in the license 

application; and (iv) the changes do 

not degrade the safety of the 

program.” 

[ ]

[ ]
B–12 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title Suggested Response Yes

Alternative 

Procedures 

Attached

AND EITHER 

 this statement: “Operating, 

emergency, and security procedures 

will be developed, implemented, 

maintained, and distributed and will 

meet the Criteria in the section entitled 

‘Radiation Safety Program - Operating 

and Emergency Procedures’ in 

NUREG-1556, Volume 5, Revision 1, 

‘Consolidated Guidance About 

Materials Licenses: Program-Specific 

Guidance About Self-Shielded 

Irradiator Licenses.’” 

OR 

 alternative operating and emergency 

procedures 

[ ]

[ ]

10. Radiation Safety 

Program 

10.7 Leak Tests Submit one of the following: 

 this statement: “Leak tests will be 

performed at intervals approved by the 

NRC or as specified in the Sealed 

Source and Device Registration 

Certificate. Leak tests will be 

performed by an organization 

authorized by the NRC or an 

Agreement State to provide 

leak-testing services to other 

licensees; or by using a leak-test kit 

supplied by an organization authorized 

by the NRC or an Agreement State to 

provide leak-test kits to other licensees 

and according to the self-shielded 

irradiator manufacturer’s or 

distributor’s instructions and kit 

supplier’s instructions.” 

[ ]
B–13 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title Suggested Response Yes

Alternative 

Procedures 

Attached

OR 

 this statement: “Leak testing and 

analysis will be done by the applicant.” 

Provide the information in Appendix P 

of this NUREG supporting a request to 

perform leak testing and sample 

analysis and either state that you will 

follow the model procedures in 

Appendix P of NUREG-1556, Volume 

5, Revision 1, ‘Consolidated Guidance 

about Materials Licenses: ProgramSpecific Guidance About Self-Shielded 

Irradiators or submit alternative 

procedures.’” 

[ ]

10. Radiation Safety 

Program 

10.8 Maintenance For all maintenance, submit: 

 

 this statement: “We will maintain 

documentation of the use of all 

non-OEM replacement parts and 

components. If OEM replacement 

parts cannot be used for the shielding 

of any sealed sources, the driving unit 

of any sources, safety interlocks, or 

other electrical or mechanical 

component that could expose the 

source, reduce the shielding around 

the source(s), or compromise the 

radiation safety of the device or any 

sources, we will obtain and document 

NRC approval before beginning the 

nonroutine maintenance activity. In 

addition, if a service provider plans to 

remove any aspect of the GTRI 

irradiator-hardening hardware, we will 

discuss this matter with the NRC 

before allowing this service to be 

initiated.” 

[ ]
B–14 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title Suggested Response Yes

Alternative 

Procedures 

Attached

For routine maintenance, submit either 

of the following: 

 this statement: “We will implement 

and maintain procedures for routine 

maintenance of our self-shielded 

irradiators according to each 

manufacturer’s or distributor’s written 

recommendations and instructions.” 

OR 

 alternative procedures for the NRC’s 

review 

For nonroutine maintenance, submit 

either of the following: 

 this statement: “We will have the 

self-shielded irradiator manufacturer, 

distributor, service provider, or another 

person authorized by the NRC or an 

Agreement State perform nonroutine 

maintenance.” 

OR 

 alternative procedures for the NRC’s 

review addressing the information 

listed in Appendix Q of NUREG-1556, 

Volume 5, Revision 1, ‘Consolidated 

Guidance about Materials Licenses: 

Program-Specific Guidance About 

Self-Shielded Irradiators or submit 

alternative procedures.’” 

[ ]

[ ]

[ ]

[ ] The 

information 

listed in 

Appendix Q of 

this NUREG 

supporting a 

request to 

perform 

non-routine 

maintenance 

in-house is 

attached.
B–15 

Table B–2. Items 7 Through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal (Continued) 

Item No. and Title Suggested Response Yes

Alternative 

Procedures 

Attached

10. Radiation Safety 

Program 

10.9 Transfer and 

Transportation 

No response is needed from applicants 

during the licensing phase. However, 

before offering a Type B package for 

shipment, a licensee needs to have 

registered with NRC as a user of the 

package and obtained NRC’s approval of 

its quality assurance (QA) program. 

Transportation issues will be reviewed 

during inspection. 

Need Not Be Submitted 

with Application

11. Waste 

Management 

11.1 Self-Shielded 

Irradiator 

Disposal & 

Transfer 

The applicant does not need to provide a 

response to this item during the licensing 

phase. However, the licensee should 

develop, implement, and maintain 

self-shielded irradiator transfer and waste 

disposal procedures, including updates to 

the National Source Tracking System, in 

its radiation safety program. 

Need Not Be Submitted 

with Application

1 APPENDIX C 

2 SAFETY CULTURE POLICY STATEMENT 

C–1 

1 Safety Culture 

2 The safety culture policy statement was published in the Federal Register (76 FR 34773) on 

3 June 14, 2011 and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-

4 14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission’s (NRC’s) Agencywide 

5 Documents Access and Management System Accession Number ML11146A047. 

6 Safety Culture Policy Statement 

7 The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

8 individuals and organizations establish and maintain a positive safety culture commensurate 

9 with the safety and security significance of their activities and the nature and complexity of their 

10 organizations and functions. This includes all licensees, certificate holders, permit holders, 

11 authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

12 safety-related components, and applicants for a license, certificate, permit, authorization, or 

13 quality assurance program approval, subject to NRC authority. The Commission encourages 

14 the Agreement States, Agreement State licensees and other organizations interested in nuclear 

15 safety to support the development and maintenance of a positive safety culture, as articulated in 

16 this Statement of Policy. 

17 Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

18 commitment by leaders and individuals to emphasize safety over competing goals to ensure 

19 protection of people and the environment. Individuals and organizations performing regulated 

20 activities bear the primary responsibility for safety and security. The performance of individuals 

21 and organizations can be monitored and trended and, therefore, may be used to determine 

22 compliance with requirements and commitments and may serve as an indicator of possible 

23 problem areas in an organization’s safety culture. The NRC will not monitor or trend values. 

24 These will be the organization’s responsibility as part of its safety culture program. 

25 Organizations should ensure that personnel in the safety and security sectors have an 

26 appreciation for the importance of each, emphasizing the need for integration and balance to 

27 achieve both safety and security in their activities. Safety and security activities are closely 

28 intertwined. While many safety and security activities complement each other, there may be 

29 instances in which safety and security interests create competing goals. It is important that 

30 consideration of these activities be integrated so as not to diminish or adversely affect either; 

31 thus, mechanisms should be established to identify and resolve these differences. A safety 

32 culture that accomplishes this would include all nuclear safety and security issues associated 

33 with NRC-regulated activities. 

34 Experience has shown that certain personal and organizational traits are present in a positive 

35 safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that 

36 emphasizes safety, particularly in goal conflict situations (e.g., production, schedule, and the 

37 cost of the effort versus safety). It should be noted that although the term ‘‘security’’ is not 

38 expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

39 regulatory mission. Consequently, consideration of both safety and security issues, 

40 commensurate with their significance, is an underlying principle of this Statement of Policy.
C–2 

1 The following are traits of a positive safety culture: 

2 (1) Leadership Safety Values and Actions—Leaders demonstrate a commitment to safety in 

3 their decisions and behaviors. 

4 (2) Problem Identification and Resolution—Issues potentially impacting safety are promptly 

5 identified, fully evaluated, and promptly addressed and corrected commensurate with 

6 their significance. 

7 (3) Personal Accountability—All individuals take personal responsibility for safety. 

8 (4) Work Processes—The process of planning and controlling work activities is implemented 

9 so that safety is maintained. 

10 (5) Continuous Learning—Opportunities to learn about ways to ensure safety are sought out 

11 and implemented. 

12 (6) Environment for Raising Concerns—A safety conscious work environment is maintained 

13 where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

14 harassment, or discrimination. 

15 (7) Effective Safety Communication—Communications maintain a focus on safety. 

16 (8) Respectful Work Environment—Trust and respect permeate the organization. 

17 (9) Questioning Attitude—Individuals avoid complacency and continuously challenge 

18 existing conditions and activities in order to identify discrepancies that might result in 

19 error or inappropriate action. 

20 There may be traits not included in this Statement of Policy that are also important in a positive 

21 safety culture. It should be noted that these traits were not developed to be used for 

22 inspection purposes. 

23 It is the Commission’s expectation that all individuals and organizations, performing or 

24 overseeing regulated activities involving nuclear materials, should take the necessary steps to 

25 promote a positive safety culture by fostering these traits as they apply to their organizational 

26 environments. The Commission recognizes the diversity of these organizations and 

27 acknowledges that some organizations have already spent significant time and resources in 

28 the development of a positive safety culture. The Commission will take this into consideration 

29 as the regulated community addresses the Statement of Policy.
1 APPENDIX D 

2 CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

3 INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390) 

D–1 

1 Checklist For Requests to Withhold Proprietary Information from Public 

2 Disclosure (Under 10 CFR 2.390) 

In order to request that the U.S. Nuclear Regulatory Commission (NRC) withhold information 

from public disclosure, the applicant or licensee must submit the information, including an 

affidavit, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390, “Public 

Inspections, Exemptions, Requests for Withholding.” The applicant should submit all of the 

following: 

 A proprietary copy of the information. Brackets should be placed around the material 

considered to be proprietary. This copy should be marked as proprietary. 

 A non-proprietary copy of the information. Applicants should white out or black out the 

proprietary portions (i.e., those in the brackets), leaving the non-proprietary portions 

intact. This copy should not be marked as proprietary. 

 An affidavit that: 

 Is signed under oath and affirmation (notarization may suffice). 

 Clearly identifies (such as by name or title and date) the document to be withheld. 

 Clearly identifies the position of the person executing the affidavit. This person 

must be an officer or upper-level management official who has been delegated the 

function of reviewing the information the organization is seeking to withhold and is 

authorized to apply for withholding on behalf of the organization. 

 States that the organization submitting the information is the owner of the 

information or is required, by agreement with the owner of the information, to treat 

the information as proprietary. 

 Provides a rational basis for holding the information in confidence. 

 Fully addresses the following issues: 

 Is the information submitted to, and received by, the NRC in confidence? 

Provide details. 

 To the best of the applicant’s knowledge, is the information currently available in 

public sources? 

 Does the applicant customarily treat this information, or this type of information, 

as confidential? Explain why. 

 Would public disclosure of the information be likely to cause substantial harm to 

the competitive position of the applicant? If so, explain why in detail. The 

explanation should include the value of the information to your organization, the 

amount of effort or money expended in developing the information, and the 

ease or difficulty for others to acquire the information. 

1 APPENDIX E 

2 GUIDANCE ON FINANCIAL ASSURANCE 

E–1 

1 Guidance on Financial Assurance 

2 Determining Need for Financial Assurance 

3 If the only radioactive materials possessed are sealed sources in self-shielded irradiators, use 

4 Table E–1 to determine whether financial assurance is required. 

Table E–1. Worksheet for Determining Need for Financial Assurance for 

Self–Shielded Irradiators 

Step No. Description Cobalt-60 Cesium-137 Strontium-90 

1 Activity possessed, in Curies* 

2 Activity requiring financial 

assurance, in Curies 

10,000 100,000 1,000 

3 Divide data in Step 1 by data in 

Step 2 = FRACTION 

4 Add the fractions determined in 

Step 3 

*For ease of use by most irradiator licensees, this table uses only conventional units. The conversion to SI units is 

1 Ci = 37 GBq. 

5 If the sum of the fractions is greater than or equal to 1, the applicant will need to submit 

6 certification of financial assurance or a decommissioning funding plan [10 CFR 30.35(e)]. 

7 Licensees may follow the guidance provided in NUREG-1757 Volume 3, “Consolidated 

8 Decommissioning Guidance - Financial Assurance, Recordkeeping, and Timeliness,” on the 

9 various Financial Assurance Mechanisms authorized by the regulations to guarantee or 

10 secure funds. 

1 APPENDIX F 

2 MODEL TRAINING PROGRAM 

F–1 

1 Model Training Program 

2 To ensure the control and security of licensed material, licensees should provide individuals with 

3 training commensurate with their assigned duties. 

4 Course Content 

5 Training may be in the form of a lecture, digital versatile disc (DVD) or other video, webinar, 

6 hands-on activity, or self-study; training emphasizes practical subjects important to the safe use 

7 of the self-shielded irradiator: 

8  Radiation Safety 

9 — characteristics of types of radiation 

10 — units of radiation dose and quantity of radioactivity 

11 — radiation vs. contamination 

12 — internal vs. external exposure 

13 — biological effects of radiation 

14 — types and relative hazards of radioactive material possessed 

15 — “as low as reasonably achievable” (ALARA) philosophy 

16 — use of time, distance, and shielding to minimize exposure 

17 — use of radiation detection instruments 

18  Regulatory Requirements 

19 — applicable parts of Title 10 of the Code of Federal Regulations (CFR), “Energy,” 

20 of 10 CFR Parts 19, 20, 21, and 30 

21 — locations of use and storage of radioactive materials and devices containing 

22 radioactive materials 

23 — material control and accountability 

24 — security of radioactive materials and devices containing radioactive materials 

25 — annual reviews of radiation safety program content and implementation 

26 — license conditions, amendments, and renewals 

27 — occupational and public dose limits 

28 — transfer and disposal 

29 — applicable U.S. Department of Transportation regulations and 10 CFR 71 
F–2 

1 — recordkeeping 

2 — reporting requirements for nationally tracked sources 

3 — reporting requirements for theft or loss, incidents, exposures, etc. 

4 — licensing and inspection by regulatory agency 

5 — need for complete and accurate information (10 CFR 30.9) 

6 — employee protection (10 CFR 30.7) 

7 — deliberate misconduct (10 CFR 30.10) 

8 — security (10 CFR 37) 

9  Practical Explanation of the Theory and Operation of Each Irradiator Possessed by 

10 the Licensee 

11 — routine vs. nonroutine maintenance 

12 — operating and emergency procedures 

13 — prior events involving self-shielded irradiators 

14 Instructor’s Qualifications 

15 The individual preparing and conducting training is qualified as an radiation safety officer (RSO) 

16 or authorized user (AU) on a self-shielded irradiator license before giving training. 

17 Training Assessment 

18 Management will ensure that potential RSOs and AUs are qualified to work independently with 

19 each type of the licensee’s irradiators. This may be demonstrated by written or oral examination 

20 or by observation. 

21 Training Documentation 

22 Training should be documented, including course outlines and materials and results of testing. 

23 Maintain records of training for 3 years after the last use of licensed material by the user. 

24 Training Frequency 

25 Refresher training should be provided any time there is a significant change to the radiation 

26 safety program (e.g., new make and model of irradiator, new location). 
1 APPENDIX G 

2 TYPICAL DUTIES AND RESPONSIBILITIES 

3 OF THE RADIATION SAFETY OFFICER 

G–1 

1 Typical Duties and Responsibilities of the 

2 Radiation Safety Officer 

3 Typically, these duties and responsibilities include ensuring the following: 

4  Activities involving licensed material that the RSO considers unsafe are stopped 

5 immediately; 

6  Radiation exposures are as low as reasonably achievable (ALARA); 

7  Notices to workers are posted as required by 10 CFR 19.11, “Posting of notices 

8 to workers;” 

9  Development, distribution, implementation, and maintenance of up-to-date operating and 

10 emergency procedures to cover all likely scenarios; 

11  Investigating and incidents and responding to any emergencies; 

12  Serving as a point of contact for the NRC’s, Agreement State’s, and licensee’s, 

13 management during routine operations, emergencies, or incidents; 

14  Proper authorities are notified of incidents such as damage to sealed sources, loss of 

15 licensed material, fire, theft, etc. 

16  Unusual occurrences are investigated, cause(s) and appropriate corrective actions(s) 

17 are identified, and timely corrective action(s) are taken to prevent recurrence; 

18  Self-shielded irradiators are properly secured from unauthorized access, as described in 

19 10 CFR Part 37; 

20  Possession, installation, relocation, use, storage, repair, and maintenance of 

21 self-shielded irradiators are consistent with the limitations in the license, the sealed 

22 source and device Registration Certificate(s), and manufacturer’s specific 

23 recommendations and instructions; 

24  Potential safety and security consequences are analyzed before conducting any 

25 activities involving repair, use, maintenance, installation, or relocation that were never 

26 previously analyzed; 

27  Individuals installing, relocating, using, maintaining, or repairing self-shielded irradiators 

28 are trained and authorized as described in the license application; 

29  Evaluations of occupationally exposed individuals are performed to demonstrate that 

30 individuals are not likely to receive, in one year, a radiation dose in excess of 10 percent 

31 of the allowable limits or personnel monitoring devices are provided; 

32  When necessary, National Voluntary Laboratory Accreditation Program (NVLAP)-

33 approved personnel monitoring devices are used and exchanged at the proper intervals, 

34 and records of the results of such monitoring are maintained; 
G–2 

1  Licensed material is transported in accordance with all applicable NRC and DOT 

2 requirements. 

3  Transaction reports are prepared for nationally tracked sources. 

4  Documentation is maintained to demonstrate, by measurement or calculation, that the 

5 total effective dose equivalent to the individual member of the public likely to receive the 

6 highest dose from the licensed operation does not exceed the annual limit in 

7 10 CFR 20.1301, “Dose limits for individual members of the public.” 

8  Up-to-date license is maintained and amendment and renewal request are submitted in 

9 a timely manner; 

10  Radiation safety, access authorization, and security program reviews (audits) are 

11 performed at least annually and documented; 

12  Ordering, receipt, surveys, and delivery of licensed material; 

13  Monitoring and surveys of all areas in which radioactive material is used; 

14  Performing/overseeing the inventory and leak testing of sealed sources; 

15  Training personnel; 

16  Licensed material is transferred or disposed of properly; 

17  Overseeing decontamination activities; 

18  Maintaining required records that are necessary to support the license and satisfy 

19 NRC regulations. 
1 APPENDIX H 

2 MODEL DELEGATION OF AUTHORITY FOR RADIATION 

3 SAFETY OFFICER

H–1 

1 Model Delegation of Authority for Radiation Safety Officer 

2 Memo To: Radiation Safety Officer 

3 From: Chief Executive Officer 

4 Subject: Delegation of Authority 

5 You, _______________________________, have been appointed radiation safety officer and 

6 are responsible for ensuring the safe and secure use of radiation. You are responsible for 

7 managing the Radiation Protection Program, identifying radiation protection problems, initiating, 

8 recommending, or providing corrective actions, verifying implementation of corrective actions, 

9 stopping unsafe activities, and ensuring compliance with regulations. You are hereby delegated 

10 the authority necessary to meet those responsibilities, including prohibiting the use of byproduct 

11 material by employees who do not meet the necessary requirements and shutting down 

12 operations, when justified, to maintain radiation safety. You are required to notify management 

13 if staff does not cooperate and does not address radiation safety issues. In addition, you are 

14 free to raise issues with the U.S. Nuclear Regulatory Commission at any time. It is estimated 

15 that you will spend _____ hours per week conducting radiation protection activities. 

16 ____________________________________ ____________________ 

17 Signature of Management Representative Date 

18 I accept the above responsibilities, 

19 _____________________________________ ____________________ 

20 Signature of Radiation Safety Officer Date 

21 cc: Affected department heads 

1 APPENDIX I 

2 J. L. SHEPHERD ORDER 

3 ADAMS Accession No. ML15210A628

I–1 

1 J. L. Shepherd Order 

2 JULY 3, 1984 

3 UNITED STATES 

4 NUCLEAR REGULATORY COMMISSION 

5 URGENT NOTICE 

6 TO ALL LICENSEES WHO POSSESS J. L. SHEPHERD IRRADIATORS 

7 An NRC licensee recently identified a malfunction in the lock mechanism of its J. L. Shepherd 

8 self-shielded irradiator which could have resulted in a radiation overexposure. Although no 

9 overexposure appears to have occurred, the potential hazard warrants immediate preventive 

10 action. Therefore, we have prepared the enclosed Order which requires the use of radiation 

11 survey equipment when the irradiators are being used. 

12 If you possess a J. L. Shepherd Mark I or Model 81-22 self-shielded irradiator, do not use it 

13 unless you provide appropriate radiation monitoring as specified in the Order. If you do not 

14 currently possess the appropriate equipment, you must obtain it before you resume use of your 

15 irradiator. Also, you should report any problems to your nearest NRC regional office 

16 immediately. Do not attempt to repair an irradiator, or allow anyone else to attempt repairs, 

17 unless specific authorization for repair of the irradiator which you possess is provided in an NRC 

18 license. 

19 We suggest that you review who has access to your irradiator, and establish strict controls to 

20 assure that no untrained personnel have access. Trained persons who continue to use the 

21 irradiator should conduct careful radiation surveys as specified in the Order. Irradiator doors 

22 should be opened slowly, to minimize any accidental exposure and to avoid “blanking out” of 

23 instruments due to high exposure rates. Any unusual meter reading should be taken as 

24 evidence of a problem. 

25 We are including in this mailing certain licensees about which we are uncertain whether they 

26 possess J. L. Shepherd irradiators. If you do not possess a J. L. Shepherd irradiator, please 

27 disregard this notice. 

28 Because this Order is effective immediately, it is important that you notify your radiation safety 

29 personnel immediately, and retain this Order with your license records. Questions and 

30 comments may be directed to your nearest NRC regional office. 

31 Sincerely, 

32 /RA/ 

33 Richard E. Cunningham, Director 

34 Division of Fuel Cycle and Material Safety 

35 Enclosure: Order Modifying License 

 
I–2 

1 UNITED STATES OF AMERICA 

2 NUCLEAR REGULATORY COMMISSION 

3 OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS 

4 WASHINGTON, D.C. 20555 

5 ORDER MODIFYING CERTAIN LICENSES (EFFECTIVE IMMEDIATELY) 

6 I 

7 Recently, the Nuclear Regulatory Commission (NRC) staff was notified by a licensee of the 

8 failure of a locking mechanism on a self-shielded irradiator which could have resulted in a 

9 radiation overexposure. (“Self-shielded” irradiators are designed so that the radioactive source 

10 remains in a shielded position at all times, both during storage and during irradiations. 

11 Therefore, the irradiators need not be placed in a shielded room.) 

12 The irradiator is a J. L. Shepherd Mark I, containing about 6,000 curies of cesium 137. The unit 

13 is operated as follows: (1) With the source in its shielded storage position, the shielded door is 

14 opened, (2) materials to be irradiated are placed inside the irradiator chamber, (3) the shielded 

15 door is closed, (4) the radioactive source is raised into the irradiation chamber, (5) after 

16 irradiation is complete, the source is lowered, and (6) the door is opened for removal of 

17 irradiated materials. 

18 The shielded door is interlocked so that it should not open when the radioactive source is in the 

19 irradiation chamber. However, in the case reported to NRC, the lock mechanism failed. In such 

20 a situation, an operator who opens the shielded door with the source raised could be subjected 

21 to substantial radiation exposure. The J. L. Shepherd Model 81-22 irradiator employs an 

22 interlock similar to the Mark I. 

23 The NRC staff has examined the irradiator in question and confirmed the defect. Furthermore, 

24 a New York City inspector checking a J. L. Shepherd Mark I irradiator in New York reported a 

25 malfunctioning interlock system. NRC and the Agreement States are studying the problem 

26 further to assess its generic implications. 

27 Based on the foregoing, I have concluded that the possibility of failure of locking mechanisms 

28 and/or mechanical timers on J. L. Shepherd Mark I and Model 81-22 irradiators represents a 

29 potential radiation hazard warranting immediate preventive action pending further investigation. 

30 I have determined, therefore, that the public health, safety, and interest require that the 

31 restrictions on the use of such irradiators as prescribed in Section II of this Order should be 

32 made immediately effective. 

33 II 

34 Accordingly, pursuant to Sections 81, 116 I, 162 o, and 182 of the Atomic Energy Act of 1954, 

35 as amended, and 10 CFR Parts 2 and 30 of the Commission’s regulations, IT IS HEREBY 

36 ORDERED, EFFECTIVE IMMEDIATELY, THAT: 

37 Each license that authorizes possession of byproduct material in a J. L. Shepherd Mark I or 

38 Model 81-22 self-shielded irradiator is hereby amended to add the following conditions: 

39 1. The J. L. Shepherd irradiator shall not be used unless the licensee provides a calibrated 

40 and operable radiation survey meter or room monitor for use with the irradiator. 
I–3 

1 2. The irradiator door shall not be opened until the operator has checked visual indicators to 

2 verify that the source has returned to its safe storage position. 

3 3. Each room monitor (a) shall be operable at all times when the irradiator is in use, (b) shall 

4 activate a visible and audible alarm when radiation levels exceed 2 millirems per hour, 

5 (c) shall be located to detect any radiation escaping from the irradiator door, and (d) shall 

6 be located so that it is visible to the irradiator user when he is next to the irradiator. 

7 4. If a room monitor is not installed, a radiation survey meter shall be used (a) to determine 

8 the radiation level at the irradiator door when the door is closed, and (b) to check for any 

9 increase in radiation levels each time the irradiator door is opened. In conducting such 

10 checks, operators shall position themselves so as to minimize exposure to any radiation 

11 escaping from the open door. 

12 5. If abnormal radiation levels or any malfunction of the irradiator are detected at any time, 

13 the licensee shall stop use of the irradiator and immediately notify the appropriate NRC 

14 regional office by telephone. 

15 6. The licensee shall not attempt repair or authorize others to attempt repair of the irradiator 

16 except as specifically authorized in a license issued by NRC. 

17 III 

18 Any affected licensee may request a hearing on this Order. A request for a hearing shall be 

19 submitted within twenty (20) days of the date of this Order to Mr. R. E. Cunningham, Director, 

20 Division of Fuel Cycle and Material Safety, U.S. Nuclear Regulatory Commission, 

21 Washington, D.C. 20555, with a copy to the Executive Legal Director, U.S. Nuclear Regulatory 

22 Commission, Washington, D.C. 20555. ANY REQUEST FOR A HEARING SHALL NOT STAY 

23 THE IMMEDIATE EFFECTIVENESS OF THIS ORDER. 

24 IV 

25 If a hearing is requested, the Commission will issue an Order designating the time and place of 

26 any such hearing. If a hearing is held the issue to be considered at such a hearing will be: 

27 Whether, on the basis of the matters set forth in Section 1 and II of this Order, this Order should 

28 be sustained. 

29 FOR THE NUCLEAR REGULATORY COMMISSION 

30 /RA/ 

31 Richard E. Cunningham, Director 

32 Division of Fuel Cycle and Material Safety 

33 Office of Nuclear Material Safety and Safeguards 

34 Dated at Bethesda, Maryland 

35 this 3rd day of July, 1984 

1 APPENDIX J 

2 SUGGESTED SELF-SHIELDED 

3 IRRADIATOR AUDIT CHECKLIST 

J–1 

1 Suggested Self-Shielded Irradiator Audit Checklist 

2 Note: Not all areas indicated in audit notes are necessarily applicable to every license, and 

3 some areas might not need to be addressed during each audit. For example, licensees do not 

4 need to address areas that do not apply to the licensee’s activities, and activities that have not 

5 occurred since the last audit need not be reviewed at the next audit. 

6 Date of This Audit __________________ Date of Last Audit _______________ 

7 Next Audit ________________________ 

8 Auditor ________________________ Date ___________________________ 

9 (Signature) 

10 Management Review___________________ Date ___________________________ 

11 (Signature) 

12 Audit History 

13 A. Were previous audits conducted annually? [10 CFR 20.1101] 

14 B. Were records of previous audits maintained? [10 CFR 20.2102] 

15 C. Were any deficiencies identified during last two audits or two years, whichever is longer? 

16 D. Were corrective actions taken? Were corrective actions sufficient to prevent recurrence 

17 of the deficiency? (Look for repeated deficiencies.) 

18 Organization and Scope of Program 

19 A. Radiation Safety Officer (RSO) [License Condition (L/C)] 

20 1. If the RSO was changed, was the license amended? 

21 2. Does the new RSO meet U.S. Nuclear Regulatory Commission (NRC) training 

22 requirements? [Section 8.7.1] 

23 3. Is the RSO fulfilling his or her duties? [Appendix E of this NUREG] 

24 4. To whom does the RSO report? 

25 B. Licensed Material 

26 1. Does the license authorize all of the NRC-regulated radioactive material 

27 contained in the licensee’s self-shielded irradiators? [L/C] 

28 2. Does the total amount of radioactive material possessed by the licensee require 

29 financial assurance? [10 CFR 30.35(a)] 

 
J–2 

1 C. Are the self-shielded irradiators as described in the Sealed Source and Device (SSD) 

2 Registration Certificate? Does the licensee have copies of (or access to) the SSD 

3 Certificates? Does the licensee have the manufacturer’s or distributor’s manuals for 

4 operation and maintenance? [10 CFR 32.210] 

5 D. Are the licensee’s actual uses of their self-shielded irradiators consistent with the 

6 authorized uses listed on the license? [L/C] 

7 E. If the mailing address or places of use changed, was the license amended? [L/C] 

8 F. If control of the license was transferred or bankruptcy was filed, was NRC prior consent 

9 obtained or notification made, respectively? [10 CFR 30.34(b)(1)] 

10 Training and Instructions to Workers 

11 A. Were all workers who are likely to exceed 1 mSv [100 mrem] in a year instructed 

12 according to 10 CFR 19.12? Was refresher training provided as needed? 

13 [10 CFR 19.12] 

14 B. Did each authorized user and person independently performing routine or nonroutine 

15 maintenance attend license-required training before working with self-shielded 

16 irradiators? [Sections 8.7.2 and 8.8; Appendix D of this NUREG] 

17 C. Are training records maintained for each individual? [10 CFR 20.2102] 

18 D. Did interviews with workers reveal that they know the emergency procedures and repair, 

19 maintenance, and relocation limitations? 

20 E. Did this audit include observations of operators using the self-shielded irradiators? Did it 

21 include observations of persons performing routine or other authorized maintenance? 

22 F. Did the audit identify any operator error in reporting maintenance and repair or operation 

23 issues to the RSO for review before starting work? 

24 Radiation Survey Instruments 

25 A. Describe the survey instruments that the licensee possesses: 

26 1. Do they meet the NRC’s criteria? [Appendix K of this NUREG] 

27 2. Are they appropriate for the source type(s)? 

28 3. Are they checked for function before use? 

29 4. If they are used with moving-source irradiators or during nonroutine 

30 maintenance, are they calibrated as required? [10 CFR 20.1501] 

31 B. If the licensee does not possess a radiation survey meter, are specific plans made to 

32 have one available? 

33 Location: Location/Operation verified: 
J–3 

1 C. Are calibration records, if required, maintained? [10 CFR 20.2103(a)] 

2 D. If the licensee possesses a J. L. Shepherd Mark I or Model 81-22 irradiator, is it being 

3 used in compliance with the license condition? [L/C and Appendix F of this NUREG] 

4 Self-Shielded Irradiator Inventory and Location 

5 A. Is a record kept showing the receipt of each self-shielded irradiator? 

6 [10 CFR 30.51(a)(1)] 

7 B. Has the location of any self-shielded irradiator changed since the last audit? 

8 National Source Tracking System (NSTS) 

9 A. Is the information in the NSTS concerning location, manufacturer, model, isotope, and 

10 quantity of material consistent with the inventory and with the actual information about 

11 the irradiator? [10 CFR 20.2207] 

12 B. Is the contact information in NSTS up to date? [10 CFR 20.2207(g)] 

13 C. Have there been any transactions involving the irradiator, such as a transfer, receipt, or 

14 disposal of irradiator sources? Have these transactions been reported to the NSTS 

15 using a NSTS Report? Did this report contain all required information? 

16 [10 CFR 20.2207(b), (c), and (e)] 

17 D. Has the annual reconciliation of the NSTS entry been performed each January? 

18 [10 CFR 20.2207(g)] 

19 Personnel Radiation Protection 

20 A. Are “as low as reasonably achievable” (ALARA) considerations incorporated in the 

21 radiation protection program? [10 CFR 20.1101(b)] 

22 B. Were prospective evaluations performed showing that unmonitored users receive ≤10% 

23 of limit? [10 CFR 20.1502(a)] 

24 C. Did unmonitored users’ activities change during the year, which could put them over 

25 10% of limit? 

26 D. If yes to C. above, was a new evaluation performed? 

27 E. Is external dosimetry required (for use by any user receiving >10% of limit)? Is dosimetry 

28 provided to users? 

29 1. If the licensee is using processed dosimetry 

30 a. Is the dosimetry supplier National Voluntary Laboratory Accreditation 

31 Program (NVLAP)-approved? [10 CFR 20.1501(c)] 

32 b. Are dosimetry reports reviewed by the RSO when they are received? 

 
J–4 

1 2. If the licensee is using self-reading dosimeters 

2 a. Do they have a range of zero to at least 2 mSv [200 mrem]? 

3 b. Are they checked at periods not to exceed one year for correct response 

4 to radiation? 

5 c. Are they read within ±20% of the true radiation exposure? 

6 d. Are they used under a program that prescribes action to evaluate the 

7 individual’s dose? 

8 F. Are the dosimeters exchanged or read at the license-required frequency? 

9 G. Are the records NRC Forms or their equivalent? [10 CFR 20.2104(d), 

10 10 CFR 20.2106(c)] 

11 1. Has NRC-4, “Cumulative Occupational Exposure History,” been completed? 

12 2. Has NRC-5, “Occupational Exposure Record for a Monitoring Period,” been 

13 completed? 

14 H. Are there any declared pregnant workers? 

15 1. If a worker declared her pregnancy, did the licensee comply with 10 CFR 

16 20.1208, “Done equivalent to an embryo/fetus”? [20.1502(a)] 

17 2. Were records kept of the dose to the embryo/fetus per 10 CFR 20.2106(e)? 

18 I. Are records of exposures, surveys, monitoring, and evaluations maintained? 

19 [10 CFR 20.2102, 10 CFR 20.2103, 10 CFR 20.2106] 

20 Public Dose 

21 A. Are self-shielded irradiators located and used in a manner to keep doses below 1 mSv 

22 [100 mrem] per year? [10 CFR 20.1301(a)(1)] 

23 B. Has a survey or evaluation been performed in accordance with 10 CFR 20.1501(a)? 

24 C. Have there been any additions or changes to the storage or use of surrounding areas 

25 that would necessitate a new survey or evaluation? 

26 D. Do unrestricted area radiation levels exceed 0.02 mSv [2 mrem] in any 1 hour? 

27 [10 CFR 20.1301(a)(2)] 

28 E. Are self-shielded irradiators being used or stored in a manner that would prevent 

29 unauthorized access or removal? [10 CFR 20.1801] 

30 F. Is the licensee maintaining the records required by 10 CFR 20.2103 and 

31 10 CFR 20.2107? 
J–5 

1 Operating and Emergency Procedures 

2 A. Have operating and emergency procedures been developed? [Section 8.10.2 and 

3 Appendix H of this NUREG] 

4 B. Do they contain the required elements? 

5 C. Does each operator have a current copy of the operating and emergency procedures? 

6 Does the licensee keep a copy at each irradiator’s control panel or post a notice 

7 indicating where to obtain a copy? 

8 D. Do emergency procedures address all likely scenarios? 

9 E. Did any emergencies occur since the previous audit? 

10 1. If so, were they handled properly by the operator? 

11 2. Were appropriate corrective actions taken? 

12 3. Was NRC notification or reporting required? If so, was it completed? 

13 [10 CFR 20.2201, 10 CFR 20.2202,10 CFR 20.2203] 

14 F. Were operating or emergency procedures changed since last audit? If so 

15 1. Did the licensee’s management and RSO approve the new procedures before 

16 they were implemented? 

17 2. Did the affected staff receive training on the new procedures before they were 

18 implemented? 

19 3. Are the changes consistent with the license conditions and the licensee’s 

20 commitments? 

21 4. Do the changes degrade safety? 

22 Leak Tests 

23 A. Was each sealed source leak-tested every 6 months (or at other license-prescribed 

24 intervals)? [L/C] 

25 B. Was the leak test performed as described in correspondence with the NRC and 

26 according to the license? [L/C] 

27 C. Are records of results retained with the appropriate information included? [L/C] 

28 D. Were any sources found leaking and, if so, was the NRC notified? [L/C] 

29 Maintenance of Self-Shielded Irradiators 

30 A. Are the manufacturer’s or distributor’s written procedures followed for routine (not 

31 safety-critical) cleaning and lubrication, mechanical/electrical maintenance, and repair of 

32 self-shielded irradiators? [Section 8.10.7] 
J–6 

1 B. Was nonroutine maintenance performed? [Section 8.10.7 and Appendix L of this 

2 NUREG] 

3 C. If so, was the nonroutine maintenance performed according to license requirements 

4 (e.g., regarding the extent of work, individuals performing the work, procedures, 

5 dosimetry, survey instrument, and compliance with dose limits)? [L/C] 

6 D. If nonroutine maintenance was performed by a service provider, was the service 

7 provider authorized to perform the maintenance? Were non-OEM parts used? If so, 

8 were they verified for form, fit, and function? [Section 8.10.7 and Appendix L of this 

9 NUREG] 

10 E. Since the last audit, did any operators report a need for nonroutine maintenance or 

11 repair to the RSO before requesting or conducting the work? 

12 F. Have there been any changes to the irradiator shielding or housing? Are these changes 

13 in accordance with the NRC’s Sealed Source and Device Registry? If not, was NRC 

14 approval received before making these changes? [10 CFR 32.210] 

15 Security 

16 A. Is access to the irradiator controlled so that only authorized individuals can gain access 

17 to the irradiator? Are personnel who have not been authorized escorted? [10 CFR 

18 Part 37 Subpart B] 

19 B. Have all personnel who have unescorted access to the irradiator been deemed 

20 trustworthy and reliable, been fingerprinted, and been authorized in writing for access to 

21 the irradiator? Is the list of authorized personnel up to date? [10 CFR Part 37 

22 Subpart B] 

23 C. Is a system in place so that any unauthorized access to the irradiator will be detected 

24 immediately? [10 CFR 37.49] 

25 D. Are procedures in place to ensure that any unauthorized access will be assessed to 

26 determine whether further response is required? If there have been any such accesses, 

27 was the procedure followed? [10 CFR 37.49(b)] 

28 E. Is the security plan current? Is contact information for the local law enforcement agency 

29 current? [10 CFR 37.43(a)] 

30 F. Is the security system operable? [10 CFR 37.51] 

31 G. Does the security system have a dependable means of communication to notify 

32 assessment personnel? Do personnel have a dependable means of communication to 

33 notify response staff or local law enforcement? [10 CFR 37.49(c)] 

34 H. Are all documents being retained as required? [10 CFR 37.110] 

35 I. Is all sensitive information secured and protected in accordance with the procedure? 

36 Does the procedure address all required information? [10 CFR 37.31] 
J–7 

1 J. Have personnel with access to the irradiator been trained on security procedures, 

2 including emergency response, notifications, and surveillance? [10 CFR 37.43(c)] 

3 K. Are procedures in place to ensure the safe and secure transport of Category 1 and 

4 Category 2 radioactive sources? Were the procedures followed for preplanning, license 

5 verification, coordination, advance notification, physical protection, and reporting, as 

6 applicable? [10 CFR 37.71, 37.73, 37.75, 37.77, 37.79, and 37.81] 

7 Safety Culture

8 A. Do personnel who use the irradiator feel comfortable bringing safety-related or 

9 security-related concerns to the attention of management? Are these concerns 

10 addressed? [Section 3.1 and Appendix Q of this NUREG] 

11 B. Have any actions been taken against personnel who bring such issues to the attention of 

12 management? [Section 3.1 and Appendix Q of this NUREG] 

13 Transportation 

14 A. Were any self-shielded irradiators or sources shipped since the last audit? 

15 B. If so, were 10 CFR Part 71.5 requirements followed? 

16 1. Were DOT Type A or Type B packages used? If a Type B package was used, 

17 was an NRC Certificate of Compliance granted before shipment or is the shipper 

18 registered as a user of the Type B package? Is an NRC-approved QA program 

19 in place? [10 CFR 71.5, 49 CFR 173.415, 49 CFR 173.416] 

20 2. Are package performance test records on file? [49 CFR 173.415(a)] 

21 3. Does the licensee have documentation for its special form sources? 

22 [49 CFR 173.476(a)] 

23 4. Did the package have two labels (for example, Yellow-II) with TI, Nuclide, 

24 Activity, and Hazard Class? [49 CFR 172.403, 49 CFR 173.441] 

25 5. Was the package properly marked? [49 CFR 172.301, 49 CFR 172.304, 

26 49 CFR 172.310, 49 CFR 172.324] 

27 6. Was the package closed and sealed during transport? [49 CFR 173.475(f)] 

28 7. Were shipping papers prepared, used, and maintained? [49 CFR 172.200(a)] 

29 8. Did shipping papers contain the proper entries [Shipping Name, Hazard Class, 

30 Identification Number (UN Number), Total Quantity, Package Type, Nuclide, RQ, 

31 Radioactive Material, Physical and Chemical Form, Activity (SI units required), 

32 Category of Label, TI, Shipper’s Name, Certification and Signature, Emergency 

33 Response Phone Number, and Cargo Aircraft Only (if applicable)]? 

34 [49 CFR 172.200, 49 CFR 172.201, 49 CFR 172.202, 49 CFR 172.203, 

35 49 CFR 172.204, 49 CFR 172.604] 

 
J–8 

1 9. Was the package secured against movement? [49 CFR 177.834] 

2 10. If necessary, was the shipping vehicle placarded? [49 CFR 172.504] 

3 11. If overpacks were used, were they the proper overpacks? [49 CFR 173.25] 

4 12. Were any incidents reported to DOT? [49 CFR 171.15, 49 CFR 171.16] 

5 13. Were safety and security plans documented and implemented in accordance with 

6 the plan? [49 CFR 172, Subpart I; 49 CFR 172.800; 40 CFR 172.802] 

7 14. Does the licensee possess any irradiators manufactured before 1966? 

8 [Section 8.10.9] 

9 a. If so, were any of them shipped? 

10 b. If so, were NRC and DOT exemptions, if needed, received in advance? 

11 Performance-Based Review

12 A. Conduct performance-based reviews of radiation workers performing licensed activities: 

13 1. to assess the capability of the radiation workers to keep exposures ALARA 

14 2. to assess whether radiation workers follow the operating procedures 

15 3. to assess the effectiveness of the operating procedures and compliance with the 

16 regulations, license conditions, and the licensee’s commitments submitted in 

17 support of a license (and incorporated by “tie-down” conditions) 

18 4. to ensure the safe and secure use of radioactive material 

19 5. to verify that radiation workers are cognizant of the emergency procedures and, if 

20 necessary, would be able to implement them and keep exposures ALARA 

21 B. Take any necessary actions to address programmatic and performance deficiencies with 

22 those radiation workers and facilitate immediate corrective measures. 

23 Note: Performance-based reviews may include observation of licensed activities, review of 

24 records, and interviews with key personnel. 

25 Auditor’s Independent Survey Measurements (If Any Are Made) 

26 A. Describe the type, location, and results of these measurements. [10 CFR 20.1501] 

27 B. Identify the model, serial number, and calibration date of each instrument used to make 

28 these measurements. 

29 C. Indicate whether any radiation levels exceed regulatory limits. [10 CFR 20.1301] 
J–9 

1 Notifications and Reports 

2 A. Was any radioactive material lost or stolen? If so, were these events reported? 

3 [10 CFR 20.2201, 10 CFR 30.50, 10 CFR 37.81] 

4 B. Did any reportable incidents occur? If so, were they reported? [10 CFR 20.2202, 

5 10 CFR 30.50, 10 CFR 37.81] 

6 C. Did any overexposures or high radiation levels occur? If so, were they reported? 

7 [10 CFR 20.2203, 10 CFR 30.50] 

8 D. If any events (as described in items 1 through 3 above) did occur, what was the root 

9 cause? Were corrective actions taken? If so, were those actions appropriate? 

10 E. Is the licensee aware of the telephone number for the NRC Emergency Operations 

11 Center: (301) 816-5100? 

12 Posting and Labeling 

13 A. Is NRC-3, “Notice to Workers,” posted? [10 CFR 19.11] 

14 B. Are the applicable NRC regulations and license documents posted, or is a notice posted 

15 about where they can be examined? [10 CFR 19.11, 10 CFR 21.6] 

16 C. Is all other required posting and labeling present? [10 CFR 20.1902, 10 CFR 20.1904] 

17 Recordkeeping for Decommissioning 

18 A. Are records being kept of information important to decommissioning? [10 CFR 30.35(g)] 

19 B. If so, do these records include all information outlined in 10 CFR 30.35(g)? 

20 NRC Correspondence 

21 A. Have all NRC Regulatory Issue Summaries, NRC Bulletins, NRC Information Notices, 

22 and NMSS Newsletters issued since the previous audit been received? 

23 B. If so, in response, has appropriate training been conducted and have any other 

24 necessary actions been taken? 

25 License Conditions or Issues 

26 A. Did the auditor review the license, license conditions, and “tie-down” documents 

27 (identified in the last license condition)? 

28 B. Did auditor review any other license-related issues (e.g., non-routine maintenance)? 

 
J–10 

1 Deficiencies Identified in Audit and Corrective Actions Taken 

2 A. Summarize any problems/deficiencies identified during the audit. 

3 B. If problems/deficiencies were identified in this audit, describe all corrective actions taken 

4 or planned, including their dates or prospective dates. 

5 C. Provide any other recommendations for improvement. 

6 Evaluation of Other Factors 

7 A. Is senior licensee management appropriately involved with the radiation-protection 

8 program and/or is there sufficient oversight from the RSO? 

9 B. Does the RSO have sufficient time to perform his or her radiation-safety duties? 

10 C. Does the licensee have sufficient staff to support the radiation-protection program? 
1 APPENDIX K 

2 RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND MODEL 

3 RADIATION SURVEY INSTRUMENT CALIBRATION PROGRAM 

K–1 

1 Radiation Monitoring Instrument Specifications and Model 

2 Radiation Survey Instrument Calibration Program 

3 Radiation Monitoring Instrument Specifications 

4 Any instrument used with moving-source gamma irradiators will meet the following criteria: 

5  the instrument is a radiation survey meter capable of detecting gamma radiation of more 

than 5 × 10-5 6 coulombs/kilogram (C/kg) [or up to several hundred milliroentgens (mR) 

7 per hour], which is 

8 — in the licensee’s possession 

9 — checked with a source of radiation at the beginning of each day of use to ensure 

10 that it will respond consistently to radiation 

11 — calibrated with a source of radiation annually and after any servicing or repair 

12 (other than a simple battery exchange), to ensure that exposure rates indicated 

13 by the meter do not vary from the actual exposure rates by more than ±20% 

14 (Calibrations must be performed by the instrument manufacturer or a person

15 specifically authorized by the NRC or an Agreement State.) 

16 OR 

17  the instrument is a room monitor, which 

18 — is installed in the irradiator room 

19 — is checked with a source of radiation at the beginning of each day of use to 

20 ensure that it will respond accurately to radiation and alarm at 0.02 mSv [2 mrem] 

21 per hour 

22 — activates a visible and audible alarm when radiation levels exceed 0.02 mSv 

23 [2 mrem] per hour 

24 — is positioned so that it will detect any radiation escaping from the area of the 

25 irradiator door but will still be visible to the irradiator operator when he or she is 

26 using the irradiator 

27 The “minimum detectable activity” (MDA) for your instrument should be a fraction (10 to 

28 50 percent) of the criteria you must meet. Any instrument used with a fixed-source gamma 

29 irradiator or beta irradiator should be 

30  a radiation survey meter capable of detecting gamma or beta radiation, as appropriate 

31  in the licensee’s possession or readily accessible in the event of an accident or 

32 malfunction that could reduce the shielding for the sealed source(s) 

33  checked with a source of radiation at the beginning of each day of use to ensure that it 

34 will respond consistently to radiation 
K–2 

1  calibrated with a source of radiation annually and after any servicing or repair (other than 

2 a simple battery exchange), to ensure that exposure rates indicated by the meter vary 

3 from the actual exposure rates by less than ±20% (Calibrations must be performed by 

4 the instrument manufacturer or a person specifically authorized by the NRC or an 

5 Agreement State.) 

6 Survey Instrument Calibration Program 

7 Training 

8 Before independently calibrating radiation survey instruments, an individual should complete 

9 both classroom and on-the-job training as follows: 

10  Classroom training may be in the form of lecture, video, computer-based, or self-study 

11 and will cover the following subject areas: 

12 — principles and practices of radiation protection 

13 — radioactivity measurements, monitoring techniques, and the use of radiation 

14 detection instruments 

15 — mathematics related to the use and measurement of radioactivity 

16 — biological effects of radiation 

17  On-the-job training will consist of the following: 

18 — observed authorized personnel performing radiation survey instrument calibration 

19 — conducted radiation survey meter calibrations under the supervision and in the 

20 physical presence of an individual already authorized to perform calibrations 

21 Facilities and Equipment 

22 To reduce doses received by individuals not calibrating radiation survey instruments, 

23 calibrations will be conducted in an isolated area of the facility or at times when no one else is 

24 present. 

25 The calibration source used should be well-collimated, and the calibration area should be 

26 designed to minimize scatter of radiation, which could affect the calibration process. 

27 The calibration area should be appropriately controlled so that persons entering the area will be 

28 aware if a radiation source is in use. 

29 Evaluate posting of the calibration area with appropriate radiation warning signs, as required by 

30 Subpart J of 10 CFR 20. 

31 Individuals conducting calibrations of radiation survey instruments will wear assigned dosimetry. 

32 Individuals conducting calibrations will use a calibrated and operable radiation survey 

33 instrument to ensure that unexpected changes in exposure rates are identified and corrected. 
K–3 

1 Frequency of Calibration of Radiation Measurement Instruments

2 A licensee committed to a routine or emergency radiation survey program should perform an 

3 acceptable calibration of all radiation measurement instruments and equipment at the frequency 

4 specified in NRC regulations, annually, or at the frequency recommended by the manufacturer, 

5 whichever period is shorter. 

6 Special calibrations should be performed at any time there is reason to believe that the 

7 operating characteristics of a radiation measurement instrument have changed, by repair or 

8 alteration, or whenever system performance is observed to change significantly. 

9 Routine maintenance of radiation measurement instruments should be performed as 

10 recommended by the manufacturer. 

11 Primary or secondary standard instruments used to calibrate radiation measurement 

12 instruments should be inspected frequently for consistency of performance. 

13 Calibration Sources for Dose and Dose Rate Measuring Instruments 

14 A radioactive sealed source(s) will be used for calibrating dose and dose-rate measuring 

15 radiation survey instruments, and this source will have the following characteristics: 

16  The source should approximate a point source. 

17  Calibration fields from gamma sources should be known with an accuracy when 

18 compared to secondary or primary national standards of 5 percent for dose rates 

19 greater than or equal to 1.0 μGy/h [0.1 mrad/h] and 10 percent for dose rates less than 

20 1.0 μGy/h [0.1 mrad/h]. 

21  The source should contain a radionuclide that emits radiation of identical or similar type 

22 and energy as the environment in which the calibrated device will be used. 

23  The source should be strong enough to give an exposure rate of at least 

24 7.7 microcoulomb per kilogram per hour (30 milliroentgen per hour) at 100 centimeters 

25 [e.g., 3.1 gigabecquerels (85 millicuries) of cesium-137 or 780 megabecquerels 

26 (21 millicuries) of cobalt-60]. 

27 Note: Inverse square and radioactive decay laws should be used to correct changes in 

28 exposure rate due to changes in distance or source decay. 

29 Calibration of Dose or Dose Rate Measuring Instruments 

30 There are three kinds of scales frequently used on dose and dose-rate survey meters. These 

31 are calibrated as follows: 

32  Linear readout instruments with a single calibration control for all scales should be 

33 adjusted at the point recommended by the manufacturer or at a point within the normal 

34 range of use. Instruments with calibration controls for each scale should be adjusted on 

35 each scale. After adjustment, check the response of the instrument at approximately 

36 20 percent and 80 percent of full scale. Instrument readings should be within ± x of the 

37 conventionally true value for the following ranges: 
K–4 

1 — Background to 10 μGy/h [1.0 mrad/h]; ±x = ±30% 

2 — 10 μGy/h [1.0 mrad/h] to 1.0 mGy/h [100 mrad/h]; ±x = ±20% 

3 — 1.0 mGy/h [100 mrad/h] to 10 Gy/h [1,000 Rad/h]; ±x = ±10% 

4  Logarithmic readout instruments, which commonly have a single readout scale 

5 spanning several decades, normally have two or more adjustments. Adjust the 

6 instrument for each scale according to site specifications or the manufacturer’s 

7 specifications. After adjustment, check the calibration at a minimum of one point on 

8 each decade. Instrument readings should have a maximum deviation from the 

9 conventionally true value as described for linear readout instruments. 

10  Digital readout instruments should be calibrated the same as linear 

11 readout instruments. 

Note: Readings above 2.58 x 10-4 12 coulomb per kilogram per hour (1 roentgen/hour) need not 

13 be calibrated, unless the licensee expects to make measurements at higher dose rates; 

14 regardless, such scales should be checked for operation and response to radiation. 

15 Calibration of Surface Contamination Measurement Instruments 

16 Instruments used to detect surface contamination usually consist of a count-rate meter and a 

17 detector that is appropriate for the type of radiation(s) being measured. 

18 The efficiency of radiation survey meters must be determined by using radiation sources with 

19 similar energies and types of radiation that users of the radiation survey instrument intend to 

20 measure. 

21 If each scale has a calibration potentiometer, the reading should be adjusted to respond to the 

22 calibration source at approximately 80 percent of full scale, and the response at approximately 

23 20 percent of full scale should be observed. If only one calibration potentiometer is available, 

24 the response should be adjusted at mid-scale on one of the scales, and response on the other 

25 scales should be observed. The instrument efficiency factor (e.g., cpm/dpm) thus obtained 

26 should have a signal-to-noise ratio, including the compilation of source and instrument 

27 uncertainties, of ±x for the following ranges: 

28  alpha measurement

0.01 Bq/cm2

 to 2.0 Bq/cm2 (60 to 12,000 dpm/100 cm2 29 ); ±x = ±20% 

 2.0 Bq/cm2

 to 200 Bq/cm2 (12,000 to 1,200,000 dpm/100 cm2 30 ); ±x = ±10% 

31  beta measurement

0.05 Bq/cm2

 to 2.0 Bq/cm2 (300 to 12,000 dpm/100 cm2 32 ); ±x = ±20% 

2.0 Bq/cm2

 to 200 Bq/cm2 (12,000 to 1,200,000 dpm/100 cm2 33 ); ±x = ±10% 

34 
K–5 

1 Calibration Records 

2 Calibration records for all radiation survey instruments should indicate the procedure used and 

3 the results of the calibration. The records should include the following: 

4  the owner or user of the radiation survey instrument 

5  a description of the radiation survey instrument that includes the manufacturer’s name, 

6 model number, serial number, and type of detector 

7  a description of the calibration source, including the exposure rate at a specified 

8 distance or activity on a specified date 

9  for each calibration point, the calculated exposure rate or count rate, the indicated 

10 exposure rate or count rate, the deduced correction factor (the calculated exposure rate 

11 or count rate divided by the indicated exposure rate or count rate), and the scale 

12 selected on the radiation survey instrument 

13  the exposure reading indicated with the radiation survey instrument in the “battery 

14 check” mode (if available on the instrument) 

15  for radiation survey instruments with external detectors, the angle between the radiation 

16 flux field and the detector (i.e., parallel or perpendicular) 

17  for radiation survey instruments with internal detectors, the angle between the radiation 

18 flux field and a specified surface of the instrument 

19  for radiation detectors with removable shielding, an indication of whether the shielding 

20 was in place or removed during the calibration procedure 

21  the exposure rate or count rate from a check source, if used 

22  the name and signature of the individual who performed the calibration and the date on 

23 which the calibration was performed 

24 The following information will be attached to the radiation survey instrument as a calibration 

25 sticker or tag: 

26  for dose and dose-rate measuring instruments, the source radionuclide used to calibrate 

27 the radiation survey instrument (with correction factors) for each scale 

28  for surface contamination measurement instruments, the efficiency of the radiation 

29 survey instrument, for each radionuclide the instrument will be used to measure (if 

30 efficiency is not calculated before each use) 

31  for each scale or decade not calibrated, an indication that the scale or decade was 

32 checked only for function but not calibrated 

33  the date of calibration and the next calibration due date 

34  the apparent exposure rate or count rate from the check source, if used 
K–6 

1 Reference: Detailed information about portable radiation survey instrument calibration may be 

2 obtained by referring to American National Standards Institute (ANSI)-N323AB-2013, 

3 “American National Standard for Radiation Protection Instrumentation Test and Calibration, 

4 Portable Survey Instruments.” 
1 APPENDIX L 

2 GUIDANCE FOR DEMONSTRATING THAT UNMONITORED INDIVIDUALS 

3 ARE NOT LIKELY TO RECEIVE EXPOSURES EXCEEDING 10 PERCENT OF 

4 THE ALLOWABLE LIMITS 

L–1 

1 Guidance for Demonstrating that Unmonitored Individuals are not Likely to 

2 Receive Exposures Exceeding 10 Percent of the Allowable Limits 

3 Dosimetry is required for individuals likely to receive, in a year from sources external to the 

4 body, a dose in excess of the limits in Title 10 of the Code of Federal Regulations (CFR) 

5 10 CFR 20.1502(a). To demonstrate that dosimetry is not required, a licensee is required, by a 

6 standard license condition, to perform a prospective evaluation to demonstrate that its workers 

7 are not likely to exceed these limits. 

8 The most common way that individuals might exceed these limits is by performing frequent 

9 routine maintenance on the irradiator. However, for most self-shielded irradiators, even these 

10 activities result in individuals receiving minimal doses. 

11 Example

12 The following is an example of an estimate of the dose received by the extremities and whole 

13 body of a person performing routine maintenance (cleaning and lubrication) on a self-shielded 

14 irradiator’s rotating drawer drive chain. The estimate is based on observations of individuals 

15 performing the recommended procedure according to good radiation safety practices. The 

16 manufacturer can provide the following types of information: 

17  estimated time needed to perform the entire procedure (e.g., 20 minutes) 

18  expected dose rate received by the whole body of the individual, associated with the 

19 shielded source {e.g., 0.01 mSv per hour [1 mrem per hour] at 1 ft [0.3 m] from the 

20 shield} 

21  time the hands were exposed to the shielded source (e.g., 3 minutes) 

22 AND 

23  expected dose rate received by the extremities of the individual, associated with the 

24 shielded source {e.g., 0.02 mSv per hour [2 mrem per hour] on contact with the shield}. 

25 From this information, an estimate of the doses that the individual performing this procedure 

26 could receive is as follows: 

27  3.3 μSv [0.33 mrem] to the whole body 

28  0.001 mSv [0.1 mrem] to the hands 

29 Adult Workers: The applicable whole body dose limit for adult workers is 50 mSv [5 rem] 

30 per year, with individual monitoring devices required when it is likely that an individual will 

31 receive 10 percent of that value {i.e. 5 mSv [500 mrem] per year}. If one of these procedures 

32 delivers 3.3 μSv [0.33 mrem], then an adult worker could perform 1,515 of these procedures 

33 each year and remain within 10 percent of the applicable limit. 

34 The applicable extremity dose limit for adult workers is 500 mSv [50 rem] per year with 

35 individual monitoring devices required when it is likely than an individual will receive 10 percent 

36 of that value {i.e., 50 mSv [5 rem or 5,000 mrem] per year}. If one of these procedures delivers 
L–2 

1 0.001 mSv [0.1 mrem] to the hands, an individual could perform 50,000 of these procedures 

2 each year and remain within 10 percent of the applicable limit. 

3 Based on the above specific situation, no dosimetry is required if a worker performs fewer than 

4 1,515 routine maintenance procedures per year. 

5 Minors: The applicable whole body dose limit for minors is 10 percent of the annual dose limits 

6 specified for adult workers {i.e., 5 mSv [0.5 rem] per year}, with individual monitoring devices 

7 required when it is likely that a minor will receive a deep-dose equivalent in excess of 1 mSv 

8 [0.1 rem]. If one of these procedures delivers 3.3 μSv [0.33 mrem], then a minor could perform 

9 303 such procedures each year without exceeding the individual monitoring device threshold. 

10 The applicable extremity dose limit for minors is 10 percent of the annual dose limits specified 

11 for adult workers {i.e., 50 mSv [5 rem] per year}, with individual monitoring devices required 

12 when it is likely that a minor will receive a dose to the extremities in excess of 5 mSv [0.5 rem]. 

13 If one of these procedures delivers 0.001 mSv [0.1 mrem], then a minor could perform 5,000 of 

14 these procedures each year and remain within 10 percent of the applicable limit. 

15 Based on the above specific situation, no dosimetry is required if a minor worker performs fewer 

16 than 303 routine maintenance procedures per year. 

17 Declared Pregnant Women: For declared pregnant women, individual monitoring devices are 

18 required when these individuals are likely to receive, during the entire pregnancy from radiation 

19 sources external to the body, a deep-dose equivalent in excess of 1 mSv [0.1 rem]. If one of 

20 these procedures delivers 3.3 μSv [0.33 mrem], then a declared pregnant women could perform 

21 303 of these procedures during her entire pregnancy without exceeding the individual 

22 monitoring device threshold. 

23 Declared pregnant women have no requirements concerning dose to the extremities or the 

24 monitoring thereof. 

25 Based on the above specific situation, no dosimetry is required if a declared pregnant woman 

26 performs fewer than 303 routine maintenance procedures during the entire pregnancy. 

27 Guidance to Licensees 

28 Licensees who wish to demonstrate that they are not required to provide dosimetry to their 

29 workers must prepare a written evaluation similar to that shown in the example above. The 

30 expected dose rates, times, and distances used in the above example may not be appropriate 

31 to individual licensee situations. In their evaluations, licensees must use information 

32 appropriate to the various type(s) of self-shielded irradiator(s) they intend to use; this 

33 information is generally available from the irradiator manufacturer or distributor or the SSD 

34 Registration Certificate maintained by the NRC and Agreement States. 

Table L–1 may be helpful in performing a prospective evaluation.1 35 

 

1

For ease of use by most irradiator licensees, this table uses conventional units. The conversion to SI units is 

1 mrem = 0.01 mSv. 
L–3 

1 Licensees should review evaluations periodically and revise them as needed. Licensees need 

2 to check assumptions used in their evaluations to ensure that they continue to be up-to-date 

3 and accurate. For example, if workers become lax in following good radiation safety practices in 

4 the example used above, the extremities could be closer to the unshielded source, and the 

5 workers would receive correspondingly more exposure. Alternatively, workers could perform 

6 the task more slowly than the estimated 20 minutes total and 3 minutes with their hands near 

7 the unshielded source. 

Table L–1. Dosimetry Evaluation 

Dosimetry Evaluation for Model Self-Shielded Irradiator 

A. Time needed to perform the entire routine maintenance 

procedure. 

 (minutes/60) hour

B. Expected whole body dose rate received by the 

individual, determined using exposure rates measured 

on contact with the irradiator while the sealed source is 

in the shielded position. 

 mrem/h

our 

C. Time the hands were exposed to the unshielded 

source. 

 (minutes/60) hour

D. Expected extremity dose rate received by the 

individual, determined using exposure rates measured 

at the typical distance that the hands would be from the 

sealed source during the routine maintenance 

procedure. 

 mrem/h

our 

Estimated Whole Body Dose Equivalent*

Formula: ( # hours in Row A) × ( mrem/hour in Row B) = ( estimated mrem 

) × ( # of routine maintenance procedures each year) = mrem Whole Body Dose* 

Estimated Extremity Dose Equivalent†

Formula: ( # hours in Row C) × ( mrem/hour in Row D) = ( estimated mrem 

) × ( # of routine maintenance procedures each year) = mrem Extremity Dose** 

*An expected whole body dose equivalent for adult workers less than 500 mrem requires no dosimetry. The 

corresponding value for minors is 100 mrem. The corresponding value for declared pregnant women during the 

entire pregnancy is 500 mrem. 

†

An expected extremity dose equivalent for adult workers less than 5000 mrem requires no dosimetry. The 

corresponding value for minors is 500 mrem. There is no corresponding extremity value for declared pregnant 

women because the dose limit of 500 mrem over the entire gestation period is to limit dose to the fetus. 

Note: For ease of use by most irradiator licensees, this table uses conventional units. The conversion to SI units is 

1 mrem = 0.01 mSv.

1 APPENDIX M 

2 GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL MEMBERS OF THE 

3 PUBLIC WILL NOT RECEIVE DOSES EXCEEDING THE ALLOWABLE LIMITS 

M–1 

1 Guidance for Demonstrating that Individual Members of the Public Will Not 

2 Receive Doses Exceeding the Allowable Limits 

3 Licensees must ensure that 

4  the radiation dose received by individual members of the public resulting from the 

5 licensee’s possession and/or use of licensed materials does not exceed 100 mrem 

6 [1 mSv] in a calendar year 

Members of the public include persons who live, work, study, or might be near locations where 

self-shielded irradiator devices are used or stored and licensee employees whose assigned 

duties do not include the use of licensed materials and who work in the vicinity where 

irradiators are used or stored. 

7  the radiation dose in unrestricted areas does not exceed 2 mrem [0.02 mSv] in any 

8 1 hour 

As defined in 10 CFR 20.1003, the term unrestricted area means “an area, access to which is 

neither limited nor controlled by the licensee.” For purposes of this definition in 20.1003, an 

“unrestricted area” is an area where access is neither limited nor controlled by the licensees 

for purposes of limiting exposures to radiation and radioactive materials. An “unrestricted 

area” for purposes of 20.1003 may be controlled for other purposes, such as for security 

purposes (see, for ex., 10 CFR 20.1801 and 20.1802), and still be considered an “unrestricted 

area” as long as it is not required to be controlled for limiting exposure to radiation and 

radioactive materials. Typical unrestricted areas may include offices, shops, areas outside 

buildings, property, and storage areas for non-radioactive materials, and other facilities and 

laboratories where licensed materials are not normally used or stored. 

9 Licensees must show compliance with both portions of the regulation. For areas around 

10 self-shielded irradiator facilities, calculations or a combination of calculations and 

11 measurements are often used to demonstrate compliance. 

Calculation Method1 12 

13 The calculation method takes a tiered approach, going through a three-part process starting 

14 with a worst-case situation and moving toward more realistic situations. It makes the following 

15 simplifications: (i) each irradiator is a point source; (ii) typical radiation levels encountered when 

16 the source is in the shielded position are taken from either the SSD registration certificate or the 

17 manufacturer’s or distributor’s literature; and (iii) no credit is taken for any shielding found 

18 between the irradiator and the unrestricted areas. 

19 Part 1 of the calculation method is simple but conservative. It assumes that an affected 

20 member of the public is present 24 hours a day and uses only the inverse square law to 

 

1

For ease of use by most self-shielded irradiator licensees, the examples in this appendix use conventional units. 

The conversions to SI units are as follows: 1 ft = 0.305 m; 1 mrem = 0.01 mSv. 
M–2 

1 determine whether the distance between the irradiator and the affected member of the public is 

2 sufficient to show compliance with the public dose limits. Part 2 considers not only distance, but 

3 also the time that the affected member of the public is actually in the area under consideration. 

4 Part 3 considers the distance and the portion of time and dose rate while the sample is moving 

5 into or out of the irradiate position, the portion of time and dose rate while the sample is in the 

6 irradiate position, and the portion of time that the affected member of the public is present. 

7 Using this approach, licensees make only those calculations that are needed to demonstrate 

8 compliance. In many cases, licensees will need to use the calculation method through Part 1 or 

9 Part 2. The results of these calculations typically result in higher radiation levels than would 

10 exist at typical facilities but provide a conservative method for estimating doses that could 

11 be received. 

12 Example 1 

13 To better understand the calculation method, we will examine Glow-in-the-Dark Industries, Inc., 

14 a hypothetical self-shielded irradiator licensee. Yesterday, the company’s president noted that 

15 the new irradiator area is close to his secretary’s desk and he asked Tomás, the Radiation 

16 Safety Officer (RSO), to determine whether the company is complying with NRC’s regulations. 

17 The secretary’s desk is near the wall separating the reception area from the designated and 

18 locked self-shielded irradiator room where the company has located its irradiator. Tomás 

19 measures the distance from the self-shielded irradiator to the wall and assumes that the 

20 irradiator would have the maximum dose rate listed in the irradiator’s SSD registration 

21 certificate: 10 mrem per hour at one meter. This is the maximum dose rate permitted while the 

22 sample is in transit (i.e., moving into or out of the irradiation position). Figure M–1 is Tomás’ 

23 sketch of the areas in question, and Table M–1 summarizes the information Tomás has on 

24 the irradiator. 

Figure M–1. Diagram of Office and Irradiator Area. This Sketch Shows the Areas 

 Described in Examples 1 and 2.

62-pt4-9128-106a.ppt

092898

A Bird’s Eye View of Office and Irradiator Area 

15 Feet

Irradiator Room

Hallway
M–3 

Table M–1. Information Known About the Self-Shielded Irradiator 

Description of Known Information Cs-137 Self-Shielded Irradiator

Dose rate in mrem/h encountered at specified distance 

from the irradiator 

10 mrem/h at 1 meter [3.28 ft] 

Distance in feet to secretary’s chair 15 ft 

1 Example 1: Part 1 

2 Tomás’ first thought is that the distance between the irradiator and the secretary’s chair might 

3 be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a 

4 worst-case approach, he assumes (i) the self-shielded irradiator is constantly present 

5 (i.e., 24 h/d) with the samples constantly moving into and out of the irradiate position, and (ii) the 

6 secretary is constantly sitting in the desk chair (i.e., 24 h/d). Tomás proceeds to calculate the 

7 dose she might receive hourly and yearly from the self-shielded irradiator, as shown in 

8 Table M–2 below. 

Table M–2. Calculation Method, Part 1: Hourly and Annual Dose Received from Self–

Shielded Irradiator 

Step 

No. Description Input Data Result 

1 Dose received in an hour at known distance from 

irradiator, in mrem/h 

10 10 

2 Square of the distance (ft) at which the Step 1 rate 

was measured, in ft2

(3.28)2 10.8 

3 Square of the distance (ft) from the irradiator to the 

secretary’s desk in an unrestricted area, in ft2

(15)2 225 

4 Multiply the results of Step 1 by the results of 

Step 2 (this is an intermediate result) 

10 × 10.8 108 

5 Divide the result of Step 4 by the result of Step 3 to 

calculate the dose received by an individual at the 

secretary’s desk, HOURLY DOSE RECEIVED 

FROM SELF–SHIELDED IRRADIATOR, in 

mrem/h 

108/225 0.48 

6 Multiply the result of Step 5 × 24 h/d × 365 d/yr = 

MAXIMUM ANNUAL DOSE RECEIVED FROM 

SELF–SHIELDED IRRADIATOR, in mrem/yr 

0.48 × 24 × 365 4,205 

Note: The result in Step 5 demonstrates compliance with the 2 mrem in any 1 hour limit. Reevaluate if 

assumptions change. If the result in Step 6 exceeds 100 mrem/yr, proceed to Part 2 of the 

calculation method.

9 At this point, Tomás is pleased to see that the total dose that an individual could receive in any 

10 1 hour is only 0.48 mrem, but notes that an individual could receive a dose of approximately 

11 4,200 mrem in a year, much higher than the 100-mrem limit. 
M–4 

1 Example 1: Part 2 

2 Tomás reviews his assumptions and recognizes that the secretary is not at the desk 24 h/d. He 

3 decides to make a realistic estimate of the number of hours the secretary sits in the chair at the 

4 desk, keeping his other assumptions constant (i.e., the self-shielded irradiator is constantly 

5 present (24 h/d) with the samples constantly moving into and out of the irradiate position). He 

6 then recalculates the annual dose received. 

Table M–3. Calculation Method, Part 2: Annual Dose Received from 

Self–Shielded Irradiator 

Step 

No. 

Description Result 

7 A. Average number of hours per day that individual spends in area 

of concern (e.g., secretary sits at desk 5 h/d; the remainder of 

the day the secretary is away from the desk area copying, filing) 

B. Average number of days per week in area (e.g., secretary is part 

time and works 3 d/wk) 

C. Average number of weeks per year in area (e.g., secretary works 

all year) 

5 

3 

52 

8 Multiply the results of Step 7.A. by the results of Step 7.B. by the 

results of Step 7.C = AVERAGE NUMBER OF HOURS IN AREA 

OF CONCERN PER YEAR 

5 × 3 × 52 = 780

9 Multiply the results in Step 5 by the results of Step 8 = ANNUAL 

DOSE RECEIVED FROM IRRADIATOR CONSIDERING 

REALISTIC ESTIMATE OF TIME SPENT IN AREA OF CONCERN, 

in mrem/yr 

0.48 × 780 = 374

Note: If Step 9 exceeds 100 mrem in a year, proceed to Part 3 of the calculation method.

7 Although Tomás is pleased to note that the calculated annual dose received is significantly 

8 lower, he realizes it still exceeds the limit of 100 mrem in a year. 

9 Example 1: Part 3 

10 Again Tomás reviews his assumptions and recognizes that the irradiator is not constantly in use 

11 nor is the sample continuously moving into and out of the irradiating position during an 

12 irradiation cycle when the secretary is seated at the desk. As he examines the situation, he 

13 realizes he must take these factors into account. 

 
M–5 

Table M–4. Calculation Method, Part 3: Summary of Information 

Step 

No. Description Input 

10 Dose rate while the irradiator is idle, in mrem/h at 3.28 ft from the irradiator 2 

11 Dose rate while the sample is moving into and out of the irradiate position, in 

mrem/h at 3.28 ft from the irradiator 

10 

12 Dose rate while sample is irradiated, in mrem/h at 3.28 ft from the irradiator 2 

13 Maximum number of irradiations per hour 5 

14 Maximum irradiation time, in min 3 

15 Time that the sample is moving into and out of the irradiate position, in min per 

irradiation cycle 

0.20 

16 From Table M–1, distance from irradiator to secretary, in ft 15 

17 From Step 8, average number of hours that secretary is in area of concern, 

per year 

780 

Table M–5. Calculation Method, Part 3: Annual Dose Received from Irradiator 

Step 

No. Description Result 

18 [60 minus the input from Step 13 multiplied by (the input from Step 14 plus the 

input from Step 15)] divided by 60 = [60 – 5 × (3 + 0.20)] / 60 = [60 - 16] / 

60 = FRACTION OF TIME THE IRRADIATOR IS IDLE

0.73 

19 (The input from Step 13 multiplied by the input from Step 15) divided by 

60 = (5 × 0.20) / 60 = 1/60 = FRACTION OF TIME THE SAMPLE IS MOVING

into and out of the irradiating position 

0.017 

20 1 minus the result from Step 18 minus the result from Step 19 = 

1 - 0.73 - 0.017 = FRACTION OF TIME THE IRRADIATOR IS IN USE

0.253 

21 (The input from Step 10 multiplied by the result from Step 18) plus (the input 

from Step 11 multiplied by the result from Step 19) plus (the input from Step 12 

multiplied by the result from Step 20) = (2 × 0.73) + (10 × 0.017) + (2.0 × 

0.253) = 1.46 + 0.17 + 0.506 = AVERAGE DOSE RATE ENCOUNTERED AT 

3.28 FEET FROM THE IRRADIATOR, in mrem/h 

2.136 

22 The result from Step 21 multiplied by (3.28 squared divided by the input from 

Step 16 squared) = 2.136 × (3.282

 / 152) = 2.136 × (10.8 / 225) = AVERAGE 

DOSE RATE ENCOUNTERED BY THE SECRETARY in mrem/h 

0.10 

23 The result from Step 22 multiplied by the input from Step 17 = 0.10 × 780 = 

ANNUAL DOSE RECEIVED FROM IRRADIATOR CONSIDERING 

REALISTIC ESTIMATES OF TIME SPENT IN AREA OF CONCERN, DOSE 

RATES, AND IRRADIATOR USAGE, in mrem/yr 

78 

Note: If the result in Step 23 is greater than 100 mrem/yr, the licensee must take corrective actions.

1 Tomás is glad to see that the results in Step 23 show compliance with the 100 mrem in a year 

2 limit. Had the result in Step 23 been higher than 100 mrem in a year, Tomás could have done 

3 one or more of the following: 

4  Considered whether the assumptions used to determine occupancy are accurate, revise 

5 the assumptions as needed, and recalculate using the new assumptions. 
M–6 

 Calculated the effect of any shielding2 1 located between the irradiator area and the 

2 secretarial workstation; such calculation is beyond the scope of this appendix. 

3  Take corrective action (e.g., move the irradiator within the use area, move the use 

4 area, or move the secretarial workstation) and perform new calculations to 

5 demonstrate compliance. 

6 Note that in the example Tomás evaluated the unrestricted area outside only one wall of the 

7 irradiator area. Licensees also need to make similar evaluations for other unrestricted areas 

8 and to keep in mind the “as low as reasonably achievable” (ALARA) principle, taking reasonable 

9 steps to keep radiation dose received below regulatory requirements. In addition, licensees 

10 need to be alert to changes in situations (e.g., moving the self-shielded irradiator closer to the 

11 secretarial workstation, adding a second irradiator, changing the secretary to a full-time worker, 

12 or changing the estimate of the portion of time spent at the desk) and to perform additional 

13 evaluations, as needed. 

RECORDKEEPING: 10 CFR 20.2107 requires licensees to maintain records demonstrating 

compliance with the dose limits for individual members of the public. 

14 Combination Measurement-Calculation Method 

15 This method, which allows the licensee to take credit for shielding between the irradiator and the 

16 area in question, begins by measuring radiation levels in the areas, as opposed to using 

17 manufacturer- or distributor-supplied rates at a specified distance from each irradiator. These 

18 measurements must be made with calibrated radiation survey meters sufficiently sensitive to 

19 measure background levels of radiation. However, licensees must exercise caution when 

20 making these measurements, and they must use currently calibrated radiation survey 

21 instruments. A maximum dose of 100 mrem [1 mSv] received by an individual over a period of 

22 2080 hours (i.e., a “work year” of 40 h/wk for 52 wk/yr) is equal to less than 0.05 mrem [0.5 μSv] 

23 per hour. 

This rate is well below the minimum sensitivity of most commonly available GM survey 

instruments. 

24 Instruments used to make measurements for calculations must be sufficiently sensitive. An 

25 instrument equipped with a scintillation-type detector or a micro-R meter used in making very 

26 low gamma-radiation measurements should be adequate. 

27 Licensees may also choose to use environmental thermoluminescent dosimeters (TLDs) in 

28 unrestricted areas next to the irradiator area for monitoring. This direct measurement method 

29 would provide a definitive measurement of actual radiation levels in unrestricted areas without 

 

2

National Council on Radiation Protection and Measurements (NCRP) Report No. 147, “Structural Shielding Design 

and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV,” might contain helpful 

information. It is available from NCRP, 7910 Woodmont Avenue, Suite 400, Bethesda, Maryland 20814, telephone 

301-657-2652. To order electronically, access www.ncrppublications.org. 
M–7 

1 any restrictive assumptions. Records of these measurements can then be evaluated to ensure 

2 that rates in unrestricted areas do not exceed the 100 mrem/yr [1 mSv/yr] limit. 

3 Example 2 

4 As in Example 1, Tomás is the RSO for Glow-in-the-Dark Industries, Inc., a hypothetical 

5 self-shielded irradiator licensee. The company has one irradiator in a designated and locked 

6 area that adjoins an unrestricted area where a secretarial work station is located. See 

7 Figure M–1 and Table M–2 for information. Tomás wants to see whether the company complies 

8 with the public dose limits at the secretarial station. 

9 Tomás placed an environmental TLD badge in the secretarial work space for 30 days. The TLD 

10 processor sent Tomás a report indicating that the TLD received 100 mrem. 

Table M–6. Combination Measurement-Calculation Method 

Step 

No. Description 

Input Data and 

Results 

Part 1

1 Dose received by TLD, in mrem 100

2 Total hours TLD exposed 24 h/d × 30 d/mo = 720

3 Divide the results of Step 1 by the results of Step 2 = 

HOURLY DOSE RECEIVED, in mrem in an hour 

100/720 = 0.14

4 Multiply the results of Step 3 by 365 d/yr × 24 h/d = 

8784 hours in a year = MAXIMUM ANNUAL DOSE 

RECEIVED FROM IRRADIATOR, in mrem/yr 

365 × 24 × 0.14 = 

8784 × 0.14 = 1226

Note: For the conditions described above, Step 3 indicates that the dose received in any 1 

hour is less than the limit of 2 mrem/h. However, if there are any changes, the licensee would 

need to reevaluate the potential doses that could be received in any 1 hour. Step 4 indicates 

that the annual dose received would be much greater than the 100 mrem in a year allowed by 

the regulations. 

Part 2

At this point Tomás can adjust for a realistic estimate of the time the secretary spends in the 

area as he did in Part 2 of Example 1. 

Part 3

If the results of Tomás’ evaluation in Part 2 show that the annual dose received in a year 

exceeds 100 mrem, he might have to consider moving the self-shielded irradiator or the 

secretary’s desk or adding shielding to the wall. 11 1 

1 APPENDIX N 

2 ADDITIONAL NOTIFICATIONS REQUIRED FOR SELF–SHIELDED 

3 IRRADIATOR LICENSEES 

N–1 

1 Additonal Notifications Required for Self–Shielded Irradiator Licensees 

2 Note: The following list of notification and reporting requirements is provided to inform licensees 

3 about typical notification and reporting requirements that apply to their licensed activities. 

4 Licensees should note that the list is incomplete in that not all potentially applicable 

5 requirements have been included. Also, notification and reporting requirements change; 

6 therefore, licensees should consult the regulations for definitive information about current 

7 requirements.

Typical NRC Notification and Reporting Requirements for Incidents 

Event 

Telephone 

Notification 

Written 

Report Regulatory Requirement 

Package received with removable 

radioactive surface contamination exceeding 

the limits of Title 10 of the Code of Federal 

Regulations (10 CFR) 71.87(i) or 

external radiation levels exceeding the limits of 

10 CFR 71.47 

immediate 

[NRC and final 

delivery carrier 

must be 

notified] 

none 20.1906(d) 

Theft, loss, or missing of licensed material immediate 30 days 10 CFR 20.2201(a)(1)(i) 

10 CFR 20.2201(b)(1) 

10 CFR 37.81(a) 

Whole body dose greater than 0.25 Sv 

[25 rems] 

immediate 30 days 10 CFR 20.2202(a)(1)(i) 

10 CFR 20.2203(a)(1) 

Extremity dose greater than 2.5 Gy [250 rads] immediate 30 days 10 CFR 20.2202(a)(1)(iii) 

10 CFR 20.2203(a)(1) 

Whole body dose greater than 0.05 Sv 

[5 rems] in 24 hours 

24 hours 30 days 10 CFR 20.2202(b)(1)(i) 

10 CFR 20.2203(a)(1) 

Extremity dose greater than 0.5 Sv [50 rems] 

in 24 hours 

24 hours 30 days 10 CFR 20.2202(b)(1)(iii) 

10 CFR 20.2203(a)(1) 

Whole body dose greater than 0.05 Sv 

[5 rems] 

none 30 days 10 CFR 20.2203(a)(2)(i) 

Dose to individual member of public greater 

than 1 mSv [0.1 rem] 

none 30 days 10 CFR 20.2203(a)(2)(iv) 

Defect in equipment that could create a 

substantial safety hazard 

2 days 30 days 10 CFR 21.21(d)(3)(i) & (ii) 

Event that prevents immediate protective 

actions necessary to avoid exposures to 

radiation or radioactive materials that could 

exceed regulatory limits 

immediate 30 days 10 CFR 30.50(a) & (c)(2) 

 
N–2 

Typical NRC Notification and Reporting Requirements for Incidents (Continued)

Event

Telephone 

Notification

Written 

Report Regulatory Requirement

Unplanned contamination event that requires 

restricted access for more than 24 hours and 

involves a quantity of material greater than 

five times the lowest annual limit on intake for 

the material as specified in Appendix B of 

10 CFR Part 20 and requires the area to be 

restricted for a reason other than to allow 

radionuclides with half-lives less than 24 

hours to decay 

24 hours 30 days 10 CFR 30.50(b)(1) & 

(c)(2); 

Equipment is disabled or fails to function as 

designed when required to prevent radiation 

exposure in excess of regulatory limits1

24 hours 30 days 10 CFR 30.50(b)(2) & 

(c)(2);

Unplanned fire or explosion that affects the 

integrity of any licensed material or device, 

container, or equipment with licensed 

material 

24 hours 30 days 10 CFR 30.50(b)(4) & 

(c)(2);

Determination that any licensee that has not 

previously implemented the Security Orders 

(i.e., orders issued by the NRC to require 

licensees to implement interim security 

measures) or been subject to the provisions 

of 10 CFR Part 37, Subpart C will aggregate 

radioactive material to a quantity that equals 

or exceeds the Category 2 threshold 

none 90 days 

before 

aggregating 

radioactive 

material to a 

quantity that 

equals or 

exceeds the 

Category 2 

threshold 

10 CFR 37.41(a)(3) 

 

1

Notifications are required when safety interlocks malfunction or other components fail resulting in the potential risk of 

radiation exposure.
N–3 

Typical NRC Notification and Reporting Requirements for Incidents (Continued)

Event

Telephone 

Notification

Written 

Report Regulatory Requirement

Coordination with local law enforcement 

agency (LLEA) has failed, either because the 

LLEA has not responded or because the 

LLEA does not plan to participate 

3 business 

days 

Submittal of a 

written report 

concerning 

failures of 

coordination 

with LLEA as 

described in 

10 CFR 

37.45(b) is not 

required; 

however, 

licensees 

must 

document 

their efforts to 

coordinate 

with the LLEA 

and keep this 

documentation 

for 3 years 

10 CFR 37.45(b) 

Determination that an unauthorized entry 

resulted in an actual or attempted theft, 

sabotage, or diversion of Category 1 or 

Category 2 quantity of radioactive material 

As soon as 

possible (but 

not at the 

expense of 

causing delay 

or interfering 

with the LLEA 

response), 

but no later 

than 4 hours 

after 

discovery 

30 days 10 CFR 37.57(a)&(c) 

Assessment of any suspicious activity related 

to possible theft, sabotage, or diversion of 

Category 1 or Category 2 quantities of 

radioactive material 

As soon as 

possible, but 

no later than 

4 hours after 

notifying the 

LLEA 

none 10 CFR 37.57(b) 

Determination that a shipment containing a 

Category 1 quantity of material is lost or 

missing in transport 

Within 1 hour 

of the 

determination; 

also, notify 

LLEA within 1 

hour of 

determination 

30 days and 

periodic 

updates 

10 CFR 37.81(a)&(g) 
N–4 

Typical NRC Notification and Reporting Requirements for Incidents (Continued)

Event

Telephone 

Notification

Written 

Report Regulatory Requirement

Determination that a shipment containing a 

Category 2 quantity of material is lost or 

missing in transport 

Within 4 

hours of the 

determination 

and again 

within 24 

hours if the 

material has 

not yet been 

located and 

secured 

30 days 10 CFR 37.81(b)&(g) 

Discovery along the route of any actual or 

attempted theft or diversion, or suspicious 

activity, related to a Category 1 quantity of 

material in transport 

Upon 

discovery, as 

soon as 

possible; also, 

notify LLEA 

as soon as 

possible upon 

discovery 

30 days 

(except no 

report for 

suspicious 

activity) 

10 CFR 37.81(c)&(g) 

Discovery of any actual or attempted theft or 

diversion, or suspicious activity, related to a 

Category 2 quantity of material in transport 

As soon as 

possible 

30 days 

(except no 

report for 

suspicious 

activity) 

10 CFR 37.81(d)&(g) 

Upon recovery of any lost or missing 

Category 1 quantity of material 

As soon as 

possible; also, 

notify the 

LLEA as soon 

as possible 

To be included 

in the 30-day 

report of an 

event 

described in 

10 CFR 

37.81(g), if 

recovered 

during that 

time 

10 CFR 37.81(e)&(h) 

Upon recovery of any lost or missing 

Category 2 quantity of material 

As soon as 

possible 

To be included 

in the 30-day 

report of an 

event 

described in 

10 CFR 

37.81(g), if 

recovered 

during that 

time 

10 CFR 37.81(f)&(h) 

1 Note: Telephone notifications must be made to the NRC Operations Center at 301-816-5100 or 

2 by facsimile to 301-951-0550, except as noted. The Center is staffed 24 hours a day and 

3 accepts collect calls. 

 
N–5 

1 Other Types Of Notifications Include:

Telephone Notification Written Report

Regulatory 

Requirement 

Filing petition for 

bankruptcy under 

11 U.S.C. 

none immediately 

after filing 

petition 

10 CFR 30.34(h) 

Expiration of license none 60 days 10 CFR 30.36(d) 

Decision to permanently 

cease licensed activities 

at entire site

none 60 days 10 CFR 30.36(d) 

Decision to permanently 

cease licensed activities 

in any separate building 

or outdoor area that is 

unsuitable for release for 

unrestricted use 

none 60 days 10 CFR 30.36(d) 

No principal activities 

conducted for 24 months 

at the entire site

none 60 days 10 CFR 30.36(d) 

No principal activities 

conducted for 24 months 

in any separate building 

or outdoor area that is 

unsuitable for release for 

unrestricted use 

none 60 days 10 CFR 30.36(d) 

1 APPENDIX O 

2 INFORMATION FOR APPLICANTS TO CONSIDER WHEN DEVELOPING 

3 OPERATING AND EMERGENCY PROCEDURES FOR 

4 SELF-SHIELDED IRRADIATORS 

O–1 

1 Information for Applicants to Consider When Developing Operating and 

2 Emergency Procedures for Self-Shielded Irradiators 

3 Elements of Operating Procedures Applicable to All Types of Self-Shielded Irradiators 

4  Analyze each type of material to be placed in the irradiator to ensure that it is compatible 

5 with the irradiator’s design or to determine whether special procedures in addition to 

6 those given by the manufacturer or distributor are required to ensure the safe operation 

7 of the irradiator. 

8  Prepare model-specific instructions for routine inspections, test procedures, and 

9 maintenance to ensure that all interlocks, devices, and components critical to the safe 

10 operation of the irradiator are functioning properly. (Prohibited actions such as changing 

11 the safety control system or removing the source should be stated.) 

12  Develop methods to maintain accountability (e.g., use a log book to record irradiator 

13 use) and to ensure that only authorized persons will use or have access to the irradiator 

14 (e.g., control access to the irradiator’s keys or control access to the area where the 

15 irradiator is located). 

16  Define steps to take to keep radiation exposures ALARA. 

17  For each model of irradiator, define step-by-step procedures on how to operate the 

18 irradiator and how to perform routine maintenance. Information may be extracted from 

19 the manufacturer’s or distributor’s manual. 

Specific Operating Procedures Applicable to Moving-Source Irradiators1 20 

21  The irradiator should not be used unless the licensee provides a calibrated and operable 

22 radiation survey meter or a room monitor for use with the irradiator. 

23  The irradiator door should not be opened until the operator has checked visual indicators 

24 to verify that the source has returned to its safe storage position. 

25  Each room monitor should 

26 — be operable at all times when the irradiator is in use 

27 — activate a visible and audible alarm when radiation levels exceed 0.02 mSv 

28 [2 mrem] per hour 

29 — be located to detect any radiation escaping from the area of the irradiator door 

30 — be located so that it is visible to the irradiator user when they are next to 

31 the irradiator 

 

1

These procedures are required for licensees authorized for a J. L. Shepherd Mark I or Model 81-22 irradiator. 
O–2 

1  If a room monitor is not installed, a radiation survey meter should be used to 

2 — determine the radiation level at the irradiator door when the door is closed 

3 — check for any increase in radiation levels each time the irradiator door is opened. 

4 (In conducting such checks, operators should position themselves to minimize 

5 their exposure to any radiation escaping from the open door.) 

6  If abnormal radiation levels or any malfunction of the irradiator are detected at any time, 

7 the licensee should stop using the irradiator, restrict access to the area housing the 

8 irradiator, immediately notify the RSO, and determine whether a report to NRC 

9 is required. 

10  The licensee should not attempt to repair or authorize others to attempt to repair the 

11 irradiator except as specifically authorized in a license issued by NRC. 

12 Elements of Emergency Procedures Applicable to All Types of Self-Shielded Irradiators 

13  Leave the irradiator area (to reduce radiation exposure). 

14  Control access to the area (e.g., lock its door). 

15  Contact responsible individuals (e.g., have ready and use the names and phone 

16 numbers of the RSO, irradiator manufacturer or distributor, emergency response 

17 organizations such as fire department, and the NRC). 

18  Take additional steps depending on the specific situation (e.g., take surveys). 

19  As appropriate, require timely reporting to NRC. 

20 Changes to Operating and Emergency Procedures Without a License Amendment 

21 Licensees may change their operating and emergency procedures without amending their 

22 licenses if: 

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

24  Affected licensee staff are trained in the procedures before they are implemented. 

25  The changes are consistent with applicable license conditions and the procedures or 

26 commitments submitted in the license application. 

27  The changes do not degrade the safety or security of the program. 

Copies of operating and emergency procedures should be provided to all users. Post a 

current copy at each irradiator’s control panel. If posting the procedures is not practicable, 

post a notice describing all such documents and where they may be examined. 
1 APPENDIX P 

2 MODEL LEAK TEST PROGRAM 

P–1 

1 Model Leak Test Program 

2 Training 

3 Before allowing an individual to perform leak testing, the licensee must ensure that he or she 

4 has sufficient classroom and on-the-job training to show competency in performing leak testing 

5 and sample analysis independently. 

6 Classroom training may be in the form of lecture, online, video, hands-on, or self-study and 

7 should cover the following subject areas: 

8  principles and practices of radiation protection 

9  radioactivity measurements, monitoring techniques, and instrument use 

10  mathematics and calculations used for measuring radioactivity 

11  biological effects of radiation 

12 Appropriate on-the-job training consists of the following: 

13  observing authorized personnel collecting and analyzing leak test samples 

14  collecting and analyzing leak test samples under the supervision and in the physical 

15 presence of an individual authorized to perform leak testing and sample analysis 

16 Facilities and Equipment 

17  To ensure achieving the required sensitivity of measurements, analyze leak tests in a 

18 low-background area. 

19  Use a calibrated and operable survey instrument to check leak test samples for gross 

20 contamination before they are analyzed. 

21  Analyze the leak test sample using an instrument that is appropriate for the type of 

22 radiation to be measured [e.g., NaI(Tl) well-counter system for gamma emitters, liquid 

23 scintillation for beta emitters, and gas-flow proportional counter for alpha emitters]. 

24  If the sensitivity of the counting system is unknown, determine the minimum detectable 

25 activity (MDA). The MDA may be determined using the following formula: 

MDA =

2.71 + 4.65 ඥbkg ×t

t ×E

26 where: MDA = minimum detectable activity in disintegrations per minute (dpm) 

27 bkg = background count rate in counts per minute (cpm) 

28 t = background counting time in minutes 

29 E = detector efficiency in counts per disintegration 
P–2 

1 For example: 

2 where: bkg = 200 cpm 

3 E = 0.1 counts per disintegration (10 percent efficient) 

4 t = 2 minutes 

MDA = 

2.71 + 4.65 ඥ200 cpm × 2 minutes

2 × 0.1 = 

2.71 + 4.65 √400

0.2

=		

2.71 + 4.65ሺ20ሻ

0.2 		=		

2.71 + 93

0.2 		=		

95.71

0.2

=		

478.55 disintegrations

minute

becquerels ሺBqሻ		=		

1 disintegration

second

MDA =		

478.55 disintegration

minutes × 

minute

60 seconds = 7.976 Bq

5 Note: The MDA equation shown assumes that counting times for the background measurement 

6 and for the sample will be equal. MDA equations for nonequal counting times, as well as 

7 derivations of equations and discussions of limitations, can be found in “Decommissioning 

8 Health Physics—A Handbook for MARSSIM Users,” Eric W. Abelquist, published by Taylor & 

9 Francis Group, 2001. 

10 Frequency for Conducting Leak Tests of Sealed Sources 

11 Leak tests will be conducted at the frequency specified in the respective Sealed Source and 

12 Device registration certificate. If a sealed source is not registered, leak tests should be 

13 conducted at 6 month intervals, unless a different interval is established during the licensing 

14 process. Leak testing of sealed sources may be required by license condition. 

15 

16 Procedure for Performing Leak Testing and Analysis 

17  For each source to be tested, list identifying information, such as the sealed source 

18 serial number, manufacturer, model number, radionuclide, and activity. 

19  Use a radiation survey meter to monitor exposure. 

20  Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source. 

21  Number each wipe to correlate with identifying information for each source. 

22  Wipe the most accessible area where contamination would accumulate if the sealed 

23 source were leaking, but do not wipe the surface of a plated or foil source (see 

24 manufacturer’s instructions). 
P–3 

1  Select instrumentation that is sensitive enough to detect 185 becquerels (Bq) 

2 [0.005 microcurie] of the radionuclide contained in the sealed source. 

3  Using the selected instrument, count and record background count rate. 

4  Check the instrument’s counting efficiency using a standard source of the same 

5 radionuclide as the source being tested or one with similar energy characteristics. The 

6 calibration source should be in the same configuration as the sample. Accuracy of 

7 standards should be within plus or minus 5 percent of the stated value and traceable to 

8 primary radiation standards such as those maintained by the National Institute of 

9 Standards and Technology. 

10  Calculate the counting efficiency of the detector. 

Efficiency in cpm/Bq =

[(cpm from std) – (cpm from bkg)]

activity of std in Bq

11 where cpm = counts per minute 

12 std = standard 

13 bkg = background 

14 Bq = becquerel 

15  Count each wipe sample; determine net count rate. 

16  For each sample, calculate and record estimated activity in becquerels (or microcuries). 

17 The activity of the sample in becquerels may be calculated using the following formula: 

Activity of sample [Bq] = [(cpm from wipe sample) - (cpm from bkg)]

efficiency in cpm/Bq

18  Sign and date the list of sources, data, and calculations. Retain records for 3 years 

19 [under Title 10 of the Code of Federal Regulations (10 CFR) 20.2103(a)]. 

20  If the wipe test activity is 185 becquerels [0.005 microcuries] or greater, notify the 

21 radiation safety officer so that the source can be withdrawn from use and disposed of 

22 properly. Also, notify the U.S. Nuclear Regulatory Commission. 

23 Reference: See NUREG–1556, Volume 18, “Consolidated Guidance About Materials Licenses: 

24 Program-Specific Guidance About Service Provider Licenses,” if the applicant wants to provide 

25 leak testing and sample analysis as a commercial service provider. 

1 APPENDIX Q 

2 INFORMATION NEEDED TO SUPPORT APPLICANT’S REQUEST TO 

3 PERFORM NONROUTINE MAINTENANCE 

Q–1 

1 Information Needed to Support Applicant’s Request 

2 to Perform Nonroutine Maintenance 

3 Applicants should review the section in this document on “Maintenance,” which discusses, in 

4 general, licensee responsibilities before any maintenance or repair is performed. 

5 Routine maintenance is maintenance that the manufacturer and/or distributor allows their 

6 customers to perform and provides instructions in the user manual. Nonroutine maintenance is 

7 maintenance that requires specialized training and experience. Nonroutine maintenance 

8 includes repairs, removal, replacement, or alterations involving 

9  electrical and mechanical systems and components that control source or 

10 shielding movement 

11  a self-shielded irradiator’s shielding or sealed source(s) 

12  safety interlocks 

13  any other component that might affect safe operation of the device 

14  any other activities during which individuals could receive radiation doses exceeding 

15 NRC limits 

16 Follow the manufacturer’s and/or distributor’s procedures in the instruction manual describing 

17 the maintenance activity. It is preferable to use the original equipment manufacturer or 

18 distributor (OEM) supplied components or parts. Any non-OEM replacement components or 

19 parts, or the use of materials (e.g., lubricants) other than those specified or recommended by 

20 the manufacturer or distributor will need to be evaluated to ensure that they do not degrade the 

21 results of the engineering safety analysis performed and accepted as part of the device’s SSD 

22 registration. If the non-OEM part is integral to the safe operation of the device, the licensee 

23 should verify that the part will have the same form, fit, and function as the original component. 

24 In addition, the licensee should provide the part’s technical information (as specified in 

25 Section 8.10.8, “Maintenance”) to the U.S. Nuclear Regulatory Commission (NRC) for a safety 

26 review. The use of replacement parts may result in the device being a custom device, in 

27 accordance with NUREG-1556, Volume 3, “Applications for Sealed Source and Device 

28 Evaluation and Registration.” The licensee should not install this part until the NRC has 

29 approved the request. Licensees also need to ensure that, after maintenance or repair is 

30 completed, the sealed source/device is tested and functions as designed, before the unit is 

31 returned to routine use. 

32 For guidance on the use of sources that have not been supplied by the manufacturer and/or 

33 distributor, see Regulatory Issue Summary 2013-01, “Use of Aftermarket Sealed Sources 

34 Registered Under 10 CFR 32.210,” dated March 12, 2013 (ML12313A147). 

35 If nonroutine operations are not performed properly with attention to good radiation safety 

36 principles, the sealed source/device may not operate as designed, and personnel performing 

37 these tasks could receive radiation doses exceeding NRC limits. 

38 Nonroutine maintenance should be performed only by qualified and specifically authorized 

39 individuals. Self-shielded irradiator licensees should conduct these operations only after their 

40 procedures have been evaluated and specifically approved by license condition. Accordingly, 
Q–2 

1 applicants wishing to perform nonroutine maintenance must provide the following information, 

2 as appropriate: 

3  Describe the types of nonroutine maintenance to be performed. The principal reason for 

4 obtaining this information is to assist in the evaluation of the qualifications of individuals 

5 who will conduct the work and the radiation safety procedures they will follow. 

6  Identify who will perform nonroutine maintenance and describe their training and 

7 experience. Acceptable training and experience includes the following: 

8 — previous experience in nonroutine maintenance and radiation safety training 

9 — vendor maintenance certification (e.g., manufacturer’s or distributor’s courses for 

10 nonroutine operations or the equivalent) 

11 — training or previous experience as technician(s) using preplanned procedures 

12 with direct radiation-protection supervision 

13  Submit operating and emergency procedures for nonroutine maintenance. These 

14 procedures should ensure the following: 

15 — verification that the specific maintenance activity and the person who will be 

16 conducting this activity are authorized on the license before proceeding 

17 — doses to personnel and members of the public are within regulatory limits and as 

18 low as is reasonably achievable (e.g., use of shielded containers or shielding) 

19 — source is secured against unauthorized removal or access or under 

20 constant surveillance 

21 — appropriate labels and signs are used 

22 — manufacturer’s or distributor’s instructions and recommendations are followed 

23 — any non-OEM replacement components or parts or the use of materials 

24 (e.g., lubricants) other than those specified or recommended by the manufacturer 

25 or distributor are evaluated to ensure that they do not degrade the engineering 

26 safety analysis performed and accepted as part of the device registration 

27 — before being returned to routine use, the sealed source/device is tested to verify 

28 that it functions as designed and that the source integrity is not compromised 

29  Emergency procedures should be developed and reviewed for all potential 

30 accident scenarios. 

31  Confirm that individuals performing nonroutine operations will wear both whole body and 

32 extremity-monitoring devices or perform a prospective evaluation demonstrating that 

33 unmonitored individuals performing nonroutine operations are not likely to receive, in a 

34 year, a radiation dose in excess of 10 percent of the allowable limits. 
Q–3 

1  Verify possession of at least one survey instrument that meets the criteria in Appendix K 

2 of this NUREG, “General Guidelines for Radiation-Monitoring Instrument Specifications 

3 and Model Survey-Instrument Calibration Program.” 

4  Describe steps to be taken to ensure that radiation levels in areas where nonroutine 

5 operations will take place do not exceed 10 CFR 20.1301 limits. For example, 

6 applicants can do the following: 

7 — Commit to performing surveys with a survey instrument (as described above). 

8 — Specify where and when surveys will be conducted during nonroutine operations. 

9 — Commit to maintaining, for 3 years from the date of the survey, records of the 

10 survey (e.g., who performed the survey, the date of the survey, the instrument 

11 used, and the measured radiation levels corresponding to the location of those 

12 measurements), as required by 10 CFR 20.2103, “Records of surveys.” 

13 — Commit to maintaining documentation describing the work that was completed, 

14 especially replacement parts and/or sources. 

1 APPENDIX R 

2 TRANSPORTATION 

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1 TRANSPORTATION 

2 Note: The following list of U.S. Department of Transportation (DOT) regulations is provided to 

3 inform licensees about typical requirements that apply to the transportation of licensed material 

4 including the preparation of shipments of licensed material. Licensees should note that the list 

5 is incomplete in that not all potentially applicable requirements have been included. Also, 

6 transportation requirements change; therefore, licensees should consult the regulations for 

7 definitive information about current requirements. Additional information on transportation 

8 requirements may be found at the DOT Web site: http://www.dot.gov/. 

9  Table of Hazardous Materials and Special Provisions—49 CFR 172, Subpart B 

10 — 49 CFR 172.101—Purpose and use of hazardous materials table [proper 

11 shipping name, hazard class, identification number] 

12 — Table 2 to Appendix A of 49 CFR 172.101 - List of Hazardous Substances and 

13 Reportable Quantities [for radionuclides] 

14  Shipping Papers—49 CFR Part 172, Subpart C 

15 — 49 CFR 172.201—Preparation and retention of shipping papers 

16 — 49 CFR 172.202—Description of hazardous material on shipping papers 

17 — 49 CFR 172.203—Additional description requirements 

18 — 49 CFR 172.204—Shipper’s certification [if applicable] 

19  Markings—49 CFR Part 172, Subpart D 

20 — 49 CFR 172.301—General marking requirements for non-bulk packagings 

21 — 49 CFR 172.304—Marking requirements 

22 — 49 CFR 172.310—Class 7 (radioactive) materials 

23 — 49 CFR 172.324—Hazardous substances in nonbulk packagings 

24  Labeling—49 CFR Part 172, Subpart E 

25 — 49 CFR 172.400—General labeling requirements 

26 — 49 CFR 172.401—Prohibited labeling 

27 — 49 CFR 172.403—Class 7 (radioactive) material 

28 — 49 CFR 172.406—Placement of labels 

29 — 49 CFR 172.407—Label specifications 

30 — 49 CFR 172.440—RADIOACTIVE YELLOW-III label 

31  Placarding—49 CFR Part 172, Subpart F 

32 — 49 CFR 172.504—General placarding requirements 

33 — 49 CFR 172.516—Visibility and display of placards 

34 — 49 CFR 172.556—RADIOACTIVE placard 

35  Emergency Response Information—49 CFR Part 172, Subpart G 

36 — 49 CFR 172.600—Applicability and general requirements 

37 — 49 CFR 172.602—Emergency response information 
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1 — 49 CFR 172.604—Emergency response telephone number 

2 

3  Training—49 CFR Part 172, Subpart H 

4 — 49 CFR 172.702—Applicability and responsibility for training and testing 

5 — 49 CFR 172.704—Training requirements 

6  Safety and Security Plans—49 CFR Part 172, Subpart I 

7 — 49 CFR 172.800—Applicability and purpose 

8 — 49 CFR 172.802—Components of a security plan 

9  Preparation for Hazardous Materials for Transportation—49 CFR Part 173, Subpart B 

10 — 49 CFR 173.25—authorized packaging and overpacks 

11  Class 7 (Radioactive) Materials—49 CFR Part 173, Subpart I 

12 — 49 CFR 173.403—Definitions 

13 — 49 CFR 173.413—Additional design requirements for Type B packages 

14 — 49 CFR 173.416—Authorized Type B packages 

15 — 49 CFR 173.441—Radiation limitations and exclusive use provisions 

16 — 49 CFR 173. 442—Thermal limitations 

17 — 49 CFR 173. 443—Contamination control 

18 — 49 CFR 173. 447—Storage incident to transportation – general requirements 

19 — 49 CFR 173. 448—General transportation requirements 

20 — 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory Commission 

21 approved packages 

22 — 49 CFR 173. 474—Quality control for construction of packaging 

23 — 49 CFR 173. 475—Quality control requirements prior to each shipment of Class 

24 7 (radioactive) materials 

25 — 49 CFR 173.476—Approval of special form Class 7 (radioactive) materials 

26  General Information and Regulations—49 CFR Part 177, Subpart A 

27 — 49 CFR 177.817—Shipping papers 

28  Loading and Unloading—49 CFR Part 177, Subpart B 

29 — 49 CFR 177.842—Class 7 (radioactive) material 

 
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1 
1 APPENDIX S 

2 RADIATION SOURCE USE AND 

3 REPLACEMENT STUDY

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1 Radiation Source Use and Replacement Study 

2 This appendix reprints the contents of an information sheet originally released in 2008 available 

3 at http://www.nrc.gov/security/nas-facts-sheet.pdf. 

4 For more information on this topic, the National Academies Press published “Radiation Source 

5 Use and Replacement” in 2008 and this book is available at their Web site 

6 http://www.nap.edu/catalog.php?record_id=11976

7 Information Sheet: Radiation Source Use and Replacement Study 

8 Background 

9 Radiation sources are used extensively in the U.S. for industrial applications, research, and 

10 medical diagnosis and treatment. The Energy Policy Act of 2005 (EPAct) has several 

11 provisions for the Federal Government to evaluate alternative technologies for replacing 

12 radiation sources that may pose a national security risk. One of these provisions, EPAct 

13 Section 651(d), directs the U.S. Nuclear Regulatory Commission (NRC) to work with the 

14 National Academies (NA) to review current industrial, research, and commercial uses of 

15 radiation sources and identify technically and economically feasible replacements for these 

16 sources. Concerns about the safety and security of radioactive sources that could be used in a 

17 radiological dispersal device (RDD) and radiological exposure device (RED) prompted Congress 

18 to direct this study. 

19 Overview 

20 The security of radiation sources is a top priority for the NRC. The NRC’s efforts have been 

21 effective, keeping incidents involving radiation sources and radioactive materials to a minimum 

22 and the probability of their consequences low. Most lost or stolen sources are quickly 

23 recovered, resulting in minimal or no radiation exposures or contamination. The NRC works 

24 with domestic and international organizations on a variety of initiatives to make risk-significant 

25 radiation sources more secure and less vulnerable to terrorists. 

26 The regulatory programs of NRC and the Agreement States have served the Nation well, with 

27 little need for any major changes before September 11, 2001. In response to the increased 

28 terrorist threat since the attacks on that date, the NRC (in concert with the Agreement States) 

29 has strengthened the safety and security program for radiation sources to reduce the potential 

30 threat from an RDD or radiological exposure device. The NRC conducted security 

31 assessments to identify additional safety measures that can practically be implemented to 

32 further enhance the safety and security of radiation sources. These safety measures have 

33 been implemented for risk-significant sources. 

34 Approach 

35 Alternative technologies to radiation sources may include the replacement of a radiation source 

36 with an equivalent (or improved) process that does not require the use of radionuclides. 

37 Another approach is to replace a radiation source with a different radiation source that poses 

38 a lower risk to public health and safety if it were involved in an accident or used in a 

39 terrorist attack. 
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1 The NA is evaluating these options for risk-significant sources defined as Category 1 and 2 

2 sources by the International Atomic Energy Agency’s Code of Conduct on the Safety and 

3 Security of Radiation Sources (http://www-pub.iaea.org/MTCD/publications/PDF/Code4 2004_web.pdf). The majority of these sources use cobalt-60, cesium-137, or iridium-192 in 

5 medical applications, such as gamma knives and blood irradiators, and in industrial and 

6 research applications, such as radiography cameras, well logging, and industrial and research 

7 irradiators. In the U.S., about 2000 licensees regulated by the NRC and the Agreement States 

8 possess Category 1 and 2 sources. 

 Radiography camera Blood irradiator

9 The NRC will provide Congress with the recommendations of the NA on alternative technologies 

10 to radiation sources. The agency will consider the NA recommendations within its jurisdiction, 

11 as well as recommendations of the Department of Energy and the Radiation Source Protection 

12 and Security Task Force, which are also evaluating alternative technologies to radiation sources 

13 in accordance with the EPAct. 

14 The NRC welcomes recommendations to enhance the safety and security of radiation sources 

15 and lower the potential risk of terrorist use of radiation sources. Alternative technologies to 

16 radiation sources may be one approach to accomplishing this goal. However, the NRC bases 

17 its licensing decisions on whether its requirements have been met, without evaluating whether 

18 other technologies could have been used. Traditionally, market forces have driven demand for 

19 the use of radiation sources and their alternatives in devices. 

20 The NA began this study in July 2006, and the study committee has provided an open forum for 

21 discussion of alternative technologies with a wide range of stakeholders. The NA issued the 

22 committee’s report in February 2008. 

23 Visit the NA Web site at http://www8.nationalacademies.org/cp. 

24  NRC has strengthened its security program for risk-significant radiation 

25 sources to reduce the potential threat from a radiological dispersal device 

26 or radiological exposure device since 9/11.

27  The NRC works closely with its domestic and international partners to 

28 make risk-significant radiation sources more secure and less vulnerable to 

29 terrorists.
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1 The National Academies evaluated the uses of risk-significant sources that could be 

2 replaced with an equivalent process or that would pose a lower risk if an accident or 

3 attack occurs.

4  The Energy Policy Act of 2005 section 651(d) mandated this study. 

5  The study began in July 2006 and the report will be released in February 2008. 

6  The National Academies’ recommends considering the feasibility of replacing 

7 risk-significant radiation sources with alternative technologies that could increase public 

8 health and safety and security. 

9 NRC welcomes this study and others on alternative technologies or source security and 

10 will consider all recommendations as it evaluates how to further improve security and 

11 while meeting its Strategic Goals.

12  The Energy Policy Act of 2005 provisions include studies by the Radiation Source 

13 Protection and Security Task Force (August 2006) and the Department of Energy (DOE) 

14 (August 2006). The Environmental Protection Agency (EPA), DOE, and the Department 

15 of Homeland Security (DHS) are also studying alternative technologies to certain 

16 radiation sources (ongoing). 

17  The Radiation Source Protection and Security Task Force subgroups on Cesium 

18 Chloride and Alternative Technologies are expected to issue reports within the next year. 

19  The Independent External Review Panel examining licensing practices and security is 

20 expected to issue their report in April 2008. 

21  The Defense Sciences Board is expected to release a report with recommendations 

22 related to Cesium Chloride in 2008. 

23 NRC will use the Radiation Source Protection and Security Task Force to coordinate its 

24 responses with other Federal and State Agencies.

25  The Radiation Source Protection and Security Task Force was established by the 

26 Energy Policy Act of 2005 to provide continuing input to the President and Congress. Its 

27 next report is due in 2010. 

28  The National Academies’ report recommends replacing sources with caution to ensure 

29 that essential functions performed by the sources are preserved. 

30  NRC is working to develop a quantitative analysis and review of economic and 

31 environmental impacts in order to support a technical basis for regulatory decision32 making. 

33  Accomplishment of some of the recommendations will require the assistance of other 

34 Federal agencies, the Agreement States, and possibly Congress. 

Security of radiation sources is a top priority for the NRC 
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NATIONAL ACADEMY OF SCIENCES REPORT 

“RADIATION SOURCE USE AND REPLACEMENT STUDY” 

1 The National Academies study significantly advanced the NRC’s knowledge of alternative 

2 technologies to radiation sources and addressed the Congressional mandate in Section 651(d) 

3 of the Energy Policy Act of 2005 (EPAct). This report, in combination with two other studies 

4 mandated by EPAct, provides technical information and independent insights that are useful to 

5 the NRC and its Federal and State partners that are working to further enhance security of 

6 radiation sources and prevent misuse of those sources by terrorists. Specifically, the NA report 

7 reviewed the current industrial, research, commercial, and medical uses of radiation sources 

8 and identified approaches for replacing such sources with lower risk alternatives. It provides an 

9 overview of the technical and economic feasibility and risks to workers from such replacements 

10 and recommends options for implementing the identified replacements. 

11 The U.S. Environmental Protection Agency, the U.S. Department of Energy, and the Radiation 

12 Source Protection and Security Task Force (Task Force) have active programs on alternative 

13 technologies to radiation sources that will benefit from this report. Federal and State 

14 representatives plan to review this report and identify areas that require further analysis to 

15 support their alternative technology programs. For example, the Task Force plans to 

16 systematically advance the information contained in the NA report for decision making and 

17 identification of long-term solutions, with the goal of submitting a report to Congress in 2010. To 

18 meet this goal, the Task Force plans to supplement information in the NA report regarding 

19 worker risks, economic costs, implementation methods and schedules, and viable research and 

20 development programs on alternative technologies. As part of this effort, the Task Force may 

21 consider the following topics described in the NA report: 

22  International collaboration for enhancing security of radiation sources, 

23  Disposition options for existing radiation sources, 

24  Incentives for replacement technologies, 

25  Federal definition of a “radiological dispersal device,” 

26  Hazard and risk assessments for replacement technologies, 

27  Regulatory changes and effects, and 

28  Role of vendor upgrades to enhance security of and radiation sources and devices. 

29 As these actions demonstrate, the NRC is dedicated to ensuring the security of these radiation 

30 sources. The NRC welcomes recommendations from all collaborative efforts on alternative 

31 technologies to enhance security while meeting its Strategic Goals. 

32 The NRC’s Advisory Committee on the Medical Uses of Isotopes, or the ACMUI, provided 

33 comments on the NA report to the NRC staff. The ACMUI was established in 1958 under the 

34 authority of the Federal Advisory Committee Act. The ACMUI membership includes 

35 professionals from various disciplines serving in a part-time capacity. The ACMUI charter 

36 defines its purpose as providing advice on policy and technical issues that arise in regulating the 

37 medical use of byproduct material for diagnosis and therapy. The advice provided by the 

38 ACMUI helps the staff create medical regulations that are useful, realistic, practical, not overly 
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1 burdensome, and not inappropriately intrusive in the practice of medicine. A copy of their 

2 comments is attached. 

3 
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1 February 20, 2008

2 Robert J. Lewis, Director Division of Material Safety and State Agreements

3 Office of Federal and State Materials

4 and Environmental Management Programs

5 U.S. Nuclear Regulatory Commission

6 Two White Flint North

7 11545 Rockville Drive

8 Rockville, Maryland 20852-2738

9 Dear Mr. Lewis

10 The Advisory Committee on the Medical Use of Isotopes (ACMUI) appreciates the 

11 opportunity to comment on the report entitled "Radiation Source Use and Replacement" 

12 prepared by National Academy of Science (NAS). The report represents the results of a 

13 study, conducted by NAS under Section 651 of the Energy Policy Act of 2005, of the 

14 industrial, research, and commercial (including medical) uses of Category 1 and 2 radioactive 

15 sources to identify technically and economically feasible replacements for sources that pose 

16 a high risk to public health and safety in an accident or terrorist attack. The purpose of the 

17 ACMUI is to provide advice to NRC on policy and technical issues that arise in regulating the 

18 medical use of byproduct materials for diagnosis and therapy, and, in that capacity, our 

19 review of the NAS report was focused on the impact of its recommendations on the practice 

20 of medicine.

21 The ACMUI recognizes and appreciates the efforts put forth by NAS in preparing this this 

22 report. The ACMUI, however, has several concerns and comments regarding the report and 

23 its recommendations:

24 1. The report has suggested alternative replacements for CsCI, e.g., x-ray blood 

25 irradiators. However, the report does not address the efficacy of these alternative 

26 replacements for CsCI. Further study will need to be carried out on the alternatives to 

27 assure that these alternative replacements have the capacity for producing the desired 

28 result or effect and to identify any impacts. For example, a linac could be used to irradiate 

29 blood in the evening (when it is not being used to treat patients), but the hematologists need 

30 the blood irradiated immediately before use, which is generally in the daytime, not in the 

31 evenings.

32 2. The report does not address increased or enhanced security methods as an 

33 alternative. Enhanced security features would provide a more cost effective means of 

34 providing security.

35 3. Terrorist threats exist worldwide. Elimination of CsCI needs to have a global 

36 solution, otherwise, the refurbished CsCI irradiator equipment will be sent to underdeveloped 

37 countries where the environment is potentially less secure, thus increasing the overall threat 

38 risk.

39 4. The report does not acknowledge the fact that the cost of replacement, 

40 decommissioning, and disposal of current CsCI technology, as well as the increased operating 

41 cost of the X-ray alternatives, will likely be passed on to patients, thereby increasing the already 

42 high cost of medical care. One estimate suggests that implementation of the x-ray alternative 

43 could increase costs by 177% in comparison to Cs while being less reliable. 
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1 5. The report does not address the fact that the tax incentives to replace CsCI technology 

2 would not work for most hospitals, which are generally not-for-profit. 

3 6. The report does not adequately distinguish between Cs-131 and Cs-137. Cs-131 is a 

4 new and useful isotope which does not have the dispersal potential of Cs-137. However, both 

5 isotopes may be viewed as having the same threat risk by the public due to the word “Cesium”. 

6 By not distinguishing between these two isotopes of Cesium, any action on CsCI based on this 

7 report could potentially deny the useful medical treatment of Cs-131 to the public. 

8 7. The NAS report appears to have a bias against Gamma Knife Radiosurgery. The 

9 Gamma Knife has proven medical benefit. This technology provides very rapid, focused 

10 treatment versus the non-radioactive alternatives. However, the NAS report places the Gamma 

11 Knife in a negative light compared to the Linac x-ray alternatives. The successful Gamma Knife 

12 treatment method should not eliminated as it would deny needed medical treatment to patients. 

13 8. ACMUI agrees with the NRC staff observation that there are significant environmental 

14 and worker risk of using Ethylene Oxide technology. These risks were the reason that Ethylene 

15 Oxide technology was eliminated and hence returning to the Ethylene Oxide technology would 

16 be a step backward. Further, Ethylene Oxide is used for sterilizing equipment and not for 

17 sterilizing blood. 

18 ACMUI would be happy to elaborate on the above concerns, and any additional observations, 

19 resulting from our review with you, NAS, or Congress, at your convenience. 

20 Sincerely 

21 Dr.Subir Nag 

22 ACMUI 

23 http://www.nrc.gov/security/nas-facts-sheet.pdf







NUREG-1556, Vol. 5

Revision 1, Draft

Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Self-Shielded Irradiator Licenses