Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance 

About Special Nuclear 

Material of Less Than Critical 

Mass Licenses

Draft Report for Comment

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 17, Rev. 1

Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance 

About Special Nuclear 

Material of Less Than Critical 

Mass Licenses

Draft Report for Comment

Manuscript Completed: January 2017 

Date Published: January 2017

Prepared by: 

M. Arribas-Colon

M. Diaz

M. Hammond

L. Kauffman

J. Kelly

J. Lynch

S. Sahle

Office of Nuclear Material Safety and Safeguards

 

NUREG-1556

Volume 17, Rev. 1
 

1 COMMENTS ON DRAFT REPORT 

2 Any interested party may submit comments on this report for consideration by the U.S. Nuclear 

3 Regulatory Commission (NRC) staff. Comments may be accompanied by additional relevant 

4 information or supporting data. Please specify the report number NUREG–1556, Volume 17, 

5 Revision 1, in your comments, and send them by the end of the comment period specified in the 

6 Federal Register notice announcing the availability of this report. 

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

8 Docket ID NRC-2016-0121 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 Website: Go to http://www.regulations.gov and search for documents 

12 filed under Docket ID NRC-2016-0121. 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: OWFN-12-H8, 

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

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

18 Sr. Project Manager at 301-415-2746 or by e-mail at Anthony.McMurtray@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 special 

4 nuclear material (SNM) of less than critical mass. In particular, it describes the types of 

5 information needed to complete U.S. Nuclear Regulatory Commission (NRC) Form 313, 

6 “Application for Materials License.” This document describes both the methods acceptable to 

7 the NRC license reviewers in implementing the regulations and the techniques used by the 

8 reviewers in evaluating the application to determine if the proposed activities are acceptable for 

9 licensing purposes. 

10 Paperwork Reduction Act Statement 

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

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

13 by the Office of Management and Budget (OMB), approval numbers 3150-0044; 3150-0014; 

14 3150-0035; 3150-0017; 3150-0010; 3150-0158; 3150-0214; 3150-0020; 3150-0135; 3150-0009; 

15 3150-0008; 3150-0002; 3150-0123; 3150-0055; 3150-0032; and 3150-0120. 

16 Public Protection Notification 

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

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

19 currently valid OMB control number.

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 17, Revision 1, “Consolidated Guidance About 

9 Materials Licenses: Program-Specific Guidance About Special Nuclear Material of Less Than 

10 Critical Mass Licenses,” is intended for use by applicants, licensees, and NRC staff. This 

11 revision provides a general update to the previous information contained in NUREG–1556, 

12 Volume 17, issued November 2000. 
vi 

1 This report takes a risk-informed, performance-based approach to licensing special nuclear 

2 material (SNM) of less than critical mass. A team composed of staff from NRC Headquarters, 

3 NRC regional offices, and Agreement States prepared this document, drawing on their collective 

4 experience in radiation safety in general and as specifically applied to SNM. NUREG–1556, 

5 Volume 17, Revision 1, is not a substitute for NRC or Agreement State regulations. The 

6 approaches and methods described in this report are provided for information only. Methods 

7 and solutions different from those described in this report may be acceptable if they include a 

8 basis for the NRC staff to make the determinations needed to issue or renew a license. 

9 ________________________________________ 

10 Daniel S. Collins, Director 

11 Division of Materials Safety, State, Tribal and Rulemaking Programs 

12 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 or 

28 Possessed ............................................................................................. 8-2

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 or Unsealed Radioactive Material ........... 8-4

32 8.5.2   Financial Assurance and Recordkeeping for Decommissioning ............ 8-7

33 8.6 Item 6: Purpose(s) for Which Licensed Material Will be Used .......................... 8-9

34 8.7 Item 7: Individual(s) Responsible for 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 and Radiation Workers ............................................ 8-11

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

39 Areas (Instructions to Occupationally Exposed Workers and 

40 Ancillary Personnel) ............................................................................. 8-14

41 8.9 Item 9: Facilities and Equipment ..................................................................... 8-15

42 8.10 Item 10: Radiation Safety Program ................................................................. 8-17
viii 

1 8.10.1 Audit and Review of Program ......................................................... 8-18

2 8.10.2    Radiation Monitoring Instruments ................................................... 8-20

3 8.10.3    Material Receipt and Accountability ................................................ 8-22

4 8.10.4    Occupational Dose ......................................................................... 8-29

5 8.10.5    Public Dose ..................................................................................... 8-32

6 8.10.6    Operating and Emergency Procedures .......................................... 8-34

7 8.10.7    Leak Tests ...................................................................................... 8-36

8 8.10.8    Surveys ........................................................................................... 8-37

9 8.10.9    Transportation ................................................................................. 8-40

10 8.10.10 Minimization of Contamination ........................................................ 8-42

11 8.10.11 Security Program for Special Nuclear Material of Less Than 

12 Critical Mass ................................................................................... 8-43

13 8.10.11.1 Physical Protection System for Special Nuclear 

14 Material of Low Strategic Significance .......................... 8-44

15 8.10.11.2 Security Program for Category 1 and Category 2 

16 Radioactive Material ...................................................... 8-45

17 8.11 Item 11: Waste Management .......................................................................... 8-47

18 8.12 Item 12: License Fees ..................................................................................... 8-52

19 8.13 Item 13: Certification ....................................................................................... 8-52

20 9 LICENSE AMENDMENTS AND RENEWALS ............................................................... 9-1

21 9.1 Timely Notification of Transfer of Control ........................................................... 9-1

22 10 APPLICATIONS FOR EXEMPTIONS ......................................................................... 10-1

23 11 TERMINATION OF ACTIVITIES ................................................................................. 11-1

24 APPENDICES 

25 APPENDIX A U.S. NUCLEAR REGULATORY COMMISSION FORM 313 ................ A–1 

26 APPENDIX B SUGGESTED FORMAT FOR PROVIDING INFORMATION 

27 REQUESTED IN ITEMS 5 THROUGH 11 OF U.S. NUCLEAR 

28 REGULATORY COMMISSION FORM 313 .......................................... B–1 

29 APPENDIX C TYPICAL DUTIES AND RESPONSIBILITIES OF THE RADIATION 

30 SAFETY OFFICER ................................................................................ C–1 

31 APPENDIX D FACILITIES AND EQUIPMENT CONSIDERATIONS .......................... D–1 

32 APPENDIX E SUGGESTED AUDIT CHECKLIST ....................................................... E–1 

33 APPENDIX F MODEL RADIATION SURVEY INSTRUMENT 

34 CALIBRATION PROGRAM .................................................................. F–1 

35 APPENDIX G GUIDANCE FOR DEMONSTRATING THAT UNMONITORED 

36 INDIVIDUALS ARE NOT LIKELY TO EXCEED 

37 10 PERCENT OF THE ALLOWABLE LIMITS ..................................... G–1 

38 APPENDIX H PUBLIC DOSE ...................................................................................... H–1 

39 APPENDIX I RADIATION SAFETY SURVEY TOPICS .............................................. I–1 

40 APPENDIX J MODEL LEAK TEST PROGRAM ......................................................... J–1 

41 APPENDIX K U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS .......... K–1 

42 APPENDIX L NRC INCIDENT NOTIFICATIONS ........................................................ L–1 

43 APPENDIX M CRITERIA FOR ACCEPTABLE TRAINING AND EXPERIENCE 

44 FOR AUTHORIZED USERS ................................................................ M–1 

45 APPENDIX N MODEL WASTE DISPOSAL PROGRAM ............................................. N–1 
ix 

1 APPENDIX O CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

2 INFORMATION FROM PUBLIC DISCLOSURE 

3 (UNDER 10 CFR 2.390) ....................................................................... O–1 

4 APPENDIX P SAFETY CULTURE POLICY STATEMENT ......................................... P–1

xi 

1 FIGURES 

2 Figure Page 

3 1-1 A Typical Research Use of Special Nuclear Material ..................................................... 1-2 

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

5 8-1 Location of Use or Possession ....................................................................................... 8-3 

6 8-2 Methods of Certification of Financial Assurance for Decommissioning .......................... 8-7 

7 8-3 Types of Records That Must be Maintained for Decommissioning ................................ 8-8 

8 8-4 RSO Responsibilities ................................................................................................... 8-10 

9 8-5 Authorized User ........................................................................................................... 8-12 

10 8-6 Material Receipt and Accountability ............................................................................. 8-25 

11 8-7 Annual Dose Limits for Occupationally Exposed Adults ............................................... 8-30 

12 8-8 Calculating Public Dose ............................................................................................... 8-33 

13 8-9 Types of Surveys ......................................................................................................... 8-38 

14 8-10 Personnel Surveys ....................................................................................................... 8-39 

15 TABLES 

16 Table Page 

17 2-1 Who Regulates the Activity? .......................................................................................... 2-2 

18 3-1 Traits of a Positive Safety Culture .................................................................................. 3-3 

19 8-1 Types of Radioactive Materials ...................................................................................... 8-4 

20 8-2 Package Monitoring Requirements .............................................................................. 8-24 

21 8-3 Record Maintenance .................................................................................................... 8-27 

22 B–1 Suggested Format for Providing Information Requested in Items 5 through 11 

23 of NRC Form 313. ......................................................................................................... B–1 

24 F–1 Typical Survey Instruments ........................................................................................... F–1 

25 G–1 Dosimetry Evaluation ................................................................................................... G–2 

26 H–1 Standard Occupancy Factors ....................................................................................... H–3

27 I–1 Suggested Contamination Survey Frequency ................................................................ I–3 

28 I–2 Acceptable Surface Contamination Levels .................................................................... I–3 

29 I–3 Screening Values for Building Surface Contamination .................................................. I–4 

xiii 

ACKNOWLEDGMENTS 

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

2 Regulatory Commission and all of the States who provided comments and technical information 

3 that assisted in the development of this report. 

4 The working group also thanks Lisa Dimmick, John O’Donnell, Monica Ford, Tara Weidner, 

5 Tomas Herrera, and Duane White for developing the formatting and language used in many 

6 parts of the report. 

7 The Participants for this Revision 

8 Arribas-Colon, Maria 

9 Diaz, Marilyn 

10 Hammond, Michelle 

11 Kauffman, Laurie 

12 Kelly, Jason 

13 Lynch, Jeffery 

14 Sahle, Solomon

xv 

1 ABBREVIATIONS 

2 ACGIH American Conference of Governmental Industrial Hygienists 

3 ADAMS Agencywide Documents Access Management System 

4 AEA Atomic Energy Act 

5 ALARA as low as is reasonably achievable 

6 ALI Annual Limit on Intake 

7 ANSI American National Standards Institute 

8 AU authorized user 

9 Be beryllium 

10 Bkg background 

11 Bq becquerel 

12 CEDE Committed Effective Dose Equivalent 

13 CFR Code of Federal Regulations

14 cpm counts per minute 

15 DFP decommissioning funding plan 

16 DOE U.S. Department of Energy 

17 DOJ U.S. Department of Justice 

18 DOT U.S. Department of Transportation 

19 dps decay per second 

20 FR Federal Register

21 g gram 

22 GPO Government Printing Office 

23 GPS global positioning system 

24 HEU high-enriched uranium 

25 HMR hazardous materials regulation 

26 IN Information Notice 

27 IND improvised nuclear device 

28 L/C license condition 

29 LEU low-enriched uranium 

30 LLEA local law enforcement agency 

31 LLW low-level radioactive waste 

32 LSC liquid scintillation containers 

33 MC&A material control and accounting 

34 MDA minimum detectable activity 

35 mg milligram 

36 MARSSM Multi-Agency Radiation Survey and Site Investigation Manual 

37 mR milliroentgen 

38 mrem millirem 

39 mSv millisievert 

40 NCRP National Council on Radiation Protection and Measurements 

41 NHPA National Historic Preservation Act of 1966, as amended 

42 NIST National Institute of Standards and Technology 

43 NMSS Office of Nuclear Material Safety and Safeguards 

44 NRC United States Nuclear Regulatory Commission 

45 NSSDR National Sealed Source and Device Registry 

46 NSTS National Source Tracking System 

47 NVLAP National Voluntary Laboratory Accreditation Program 

48 OCFO Office of the Chief Financial Officer 

49 OMB Office of Management and Budget 

50 PII Personally Identifiable Information 
xvi 

1 P&GD policy and guidance directives 

2 Pu plutonium 

3 Pu-236 plutonium-236 

4 Pu/Be plutonium/beryllium 

5 Q quality factor 

6 QA quality assurance 

7 Rad radiation absorbed dose 

8 RDD radiological dispersal device 

9 RED radiological exposure device 

10 rem roentgen equivalent man 

11 RG Regulatory Guide 

12 RIS Reporting Identification Symbol 

13 RQ reportable quantities 

14 RSO radiation safety officer 

15 SA State Agreement 

16 SNM special nuclear material 

17 SSD sealed source and device 

18 std standard 

19 Sv sievert 

20 T1/2 radioactive material half-life 

21 TAR technical assistance requests 

22 TEDE total effective dose equivalent 

23 TLD thermoluminescent dosimeter 

24 U uranium 

25 U-233 uranium-233 

26 U-235 uranium-235 

27 U-238 uranium-238 

28 U.S.C. United States Code 

29 ZnS zinc sulfide 
1-1 

1 1 PURPOSE OF REPORT 

2 This report provides guidance to an applicant in preparing a license application for a specific 

3 license for receipt, possession, use, and transfer of special nuclear material in quantities that 

4 are not sufficient to form a “critical mass,” as well as U.S. Nuclear Regulatory Commission 

5 (NRC) criteria for evaluating a license application for such special nuclear material (SNM). 

6 Within this NUREG, the terms “SNM,” “licensed material,” and “radioactive material” are 

7 used interchangeably. 

8 SNM, as defined in Title 10 of the Code of Federal Regulations (10 CFR) Part 70.4, means 

9 (i) plutonium, uranium 233, uranium enriched in the isotope 233 or in the isotope 235, and any 

10 other material that the Commission, pursuant to the provisions of Section 51 of the Atomic 

11 Energy Act of 1954, as amended, determines to be SNM but does not include source 

12 material; or (ii) any material artificially enriched by any of the foregoing but does not include 

13 source material. 

14 SNM in quantities not sufficient to form a critical mass, as defined in 10 CFR 150.11(a), “Critical 

15 Mass,” means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of 

16 contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities 

17 not exceeding 200 grams; or any combination of them in accordance with the following formula: 

18 175 (grams contained U-235) + 50 (grams U-233) + 50 (grams Pu) = 1 

19 350 200 200 

20 .5 + .25 + .25 = 1 

21 For each kind of SNM, the applicant should determine the ratio between the requested quantity 

22 of that SNM and the quantity specified above for the same kind of SNM. The sum of such ratios 

23 for all kinds of SNM, in combination, should not exceed unity. 

24 As defined in 10 CFR 150.11(b), determine whether the exemption granted in 10 CFR 150.10 

25 applies to the receipt, possession, or use of SNM at any particular plant or other authorized 

26 location of use; a person shall include in the quantity computed according to 10 CFR 150.11(a) 

27 the total quantity of SNM a person is authorized to receive, possess, or use at the plant or other 

28 location of use at any one time. 

29 This guidance is also intended for applicants requesting authorization to possess and use 

30 sealed plutonium/beryllium (Pu/Be) neutron sources. Applicants requesting authorization to 

31 possess and use Pu/Be neutron sources can have a mass quantity up to 2,000 grams of Pu 

32 with a Be/Pu ratio that is less than or equal to 1,000, if the request is for Pu/Be sources only. 

33 The technical basis for such quantity can be found in document titled, “Technical Basis for 2000 

34 Grams of Plutonium Limit in PuBe Neutron Sources,” ADAMS Accession No. ML16190A294. If 

35 the request to possess and use Pu/Be neutron sources includes other types of SNM, then 

36 10 CFR 150.11(a) applies. 

37 After calculating the amount of SNM to confirm that it is within exemption for SNM not 

38 exceeding a critical mass as authorized in 10 CFR 150.11, the applicant should determine the 

39 level of security required to adequately protect the material at its site. See Section 8.10.11 of 

40 this NUREG. 
1-2 

1 Typical uses of SNM (see Figure 1-1) include: 

2  experiments using subcritical assemblies 

3  foil activation experiments using Pu/Be sources 

4  instrument calibration 

5  student instruction in radiation detection and measurement 

6  nuclear pacemakers 

7  U-235 target foils experiments 

8  low-enriched uranium (LEU) sources for radiation detection testing 

Figure 1-1. A Typical Research Use of Special Nuclear Material 

9 An example of how to convert activity to grams for a given radioisotope is provided below. 

Example Calculation to Convert Activity of a Radioisotope to Grams 

It may first be necessary to convert the activity in curies to disintegrations (or decays) per 

second (dps). For example: 

0.963 curies × 3.7 × 1010 = 3.5631 × 1010 dps 

In the formula, A =  × N, the value of A is equal to 3.5631 × 1010 dps. The value of = 

.693/T1/2, where T1/2 for U-233 equals 1.592 × 105

 yrs.  = [.693/(1.592 × 105 yrs × 3.156 × 107

seconds/yr)] = 1.379 × 10−13 

N = 3.5631 × 1010 dps / 1.379 × 10−13 = 2.584 × 1023 atoms × 233.039628 g/mol 

 6.02 × 1023 atoms/mol 

 2.584 × 1026 atoms × 3.871 × 10−22 = 100 grams

 

Neutron Howitzer

RSO

1556-029a.ppt

083000

Neutron Howitzer

RSO

1556-029a.ppt

083000
1-3 

1 This NUREG is not intended to address the following issues: 

2  possession of quantities of SNM in excess of critical mass 

3  applications for licenses authorizing manufacturing and distribution of SNM 

4 (NUREG–1520, “Standard Review Plan for the Review of a License Application for a 

5 Fuel Cycle Facility”) 

6 Chapter 8, “Contents of an Application” of this guide identifies the information needed to 

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

8 or letter of application for the use of unsealed and sealed SNM. The Office of Management and 

9 Budget (OMB) has approved the information collection requirements in 10 CFR Part 70 and 

10 NRC Form 313 under OMB Clearance Nos. 3150-0009 and 3150-0120, respectively. 

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

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

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

14  Discussion—provides additional information about the topic. 

15  Response from Applicant—provides suggested response(s), offers the option of an 

16 alternative reply, or indicates that no response is needed on that topic during the 

17 licensing process. 

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

19 NRC Form 313. 

20 NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 

21 through 11, as indicated on the form. Applicants should address those items on separate 

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

23 convenience and streamlined handling of SNM applications, Appendix B of this NUREG may be 

24 used to provide supporting information. 

25 Appendix B of this NUREG is also a checklist that NRC staff use to review applications and 

26 applicants can use to check for completeness. Appendices C through N of this NUREG contain 

27 additional information on various radiation safety topics, including model procedures. 

28 Appendix L of this NUREG includes a table of NRC incident notification and reporting 

29 requirements applicable to SNM. Appendix O of this NUREG provides a checklist for requesting 

30 the withholding of proprietary information from public disclosure, and Appendix P contains the 

31 NRC’s Safety Culture Policy Statement. 

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

33 dose equivalent, committed dose equivalent, committed effective dose equivalent, or total 

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

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

36 System of Units equivalent, sievert (Sv) [1 rem = 0.01 Sv], are used. This is done because 

37 10 CFR Part 20 sets dose limits in terms of rem (Sv), rather than rad or roentgen. When the 

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

39 assumed to equal 1 rem. For alpha and neutron–emitting radioactive material, 1 rad is not 
1-4 

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

2 particles and neutrons requires the use of an appropriate quality factor (Q) value. These Q 

3 values are used to convert absorbed dose (rad) to dose equivalent (rem). Tables 1004(b).1 

4 and .2 in 10 CFR 20.1004, “Units of radiation dose,” address the Q values for alpha particles 

5 and 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 (SNM), in quantities not sufficient to 

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

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

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

9 preparing an application. These applications should be filed with State officials, not with the 

10 NRC. In areas under exclusive Federal jurisdiction within an Agreement State, NRC continues 

11 to be the regulatory authority. Since under Title 10 of the Code of Federal Regulations

12 (10 CFR) 150.11 Agreement States can only regulate SNM in less than critical mass quantities, 

13 if a licensee or applicant needs authorization to possess a quantity of SNM exceeding critical 

14 mass, it should contact the NRC representative in the Office of Nuclear Material Safety and 

15 Safeguards (NMSS) for SNM licensing. Such an applicant or licensee should submit an 

16 application to NMSS, and if its application is granted, its Agreement State license should 

17 be terminated. 

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

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

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

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

recognized Indian Tribes.2 4 

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

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

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

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

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

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

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

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

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

14 regulatory authority. 

Table 2-1. Who Regulates the Activity? 

Applicant and Proposed Location of Work 

Regulatory 

Agency 

Federal agency regardless of location (except the U.S. Department of 

Energy and, under most circumstances, its prime contractors are exempt 

from licensing, in accordance with 10 CFR 70.11, “Persons using special 

nuclear 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 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 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 https://scp.nrc.gov. A request for the list can 

3 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 

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

18 be renewed annually. 

 

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

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

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

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

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

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

7 (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 (10 CFR) 70.22(d), each application 

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

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

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

12 ask for additional assurances that the individual who 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, including 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 70.9, “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  selection and assignment of a qualified individual to serve as the radiation safety officer 

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

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

30 and responsibilities 

31  ensure that radiation workers have adequate training 

32  prevention against discrimination of employees engaged in protected activities 

33 (10 CFR 70.7, “Employee protection”) 
3-2 

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

2 deliberate misconduct provisions in 10 CFR 70.7, “Employee protection” and 

3 10 CFR 70.10, “Deliberate misconduct” 

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

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

6  notification of the appropriate NRC Regional Administrator, in writing, immediately 

7 following the filing of petition for voluntary or involuntary bankruptcy 

8 [10 CFR 70.32(a)(9)], as discussed further in Section 8.2.1, “Notification of Bankruptcy 

9 Proceedings,” of this NUREG 

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

11 see the current version of the NRC’s Enforcement Policy and Inspection Procedures available in 

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

13 3.2 Safety Culture 

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

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

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

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

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

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

20 subject to NRC authority. 

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

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

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

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

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

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

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

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

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

30 from NRC’s safety culture policy statement. 

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

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

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

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

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

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

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

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

39 with NRC-regulated activities. 

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

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

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

43 safety culture policy statement and traits are not incorporated into the regulations. Safety 
3-3 

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

2 programs. For instance, for calibration or reference sources containing plutonium, quality 

3 control manufacturing and prototype testing procedures are required (for sources containing 

4 more than 0.005 microcuries of plutonium) so that the plutonium contained in the source will not 

5 be released or removed from the source under normal conditions of use resulting in the spread 

6 of plutonium contamination. The need for quality control and prototype testing procedures for 

7 calibration or reference sources may correspond with the safety culture trait specified in 

8 Table 3-1 as “Work Processes” (the process of planning and controlling work activities is 

9 implemented so that safety is maintained). However, licensees should be aware that this is just 

10 an example and should consider reviewing their radiation safety programs in order to develop 

11 and implement a safety culture commensurate with the nature and complexity of their 

12 organizations and functions. 

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

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

15 http://www.nrc.gov/about-nrc/regulatory/enforcement/safety-culture.html. 

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. 

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 (10 CFR) contain regulations applicable to special nuclear material (SNM) 

6 of less than critical mass. Some of these parts are specific to one type of license, while others 

7 are general and will apply to many, if 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 and 

14 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 37 “Physical Protection of Byproduct Material: Category 1 and 2 

20 Quantities of Radioactive Material” 

21 10 CFR Part 70 “Domestic Licensing of Special Nuclear Material” 

22 10 CFR Part 71 “Packaging and Transportation of Radioactive Material” 

23 10 CFR Part 73 “Physical Protection of Plants and Materials” 

24 10 CFR Part 74 “Material Control and Accounting of Special Nuclear Material” 

25 10 CFR Part 150 “Exemptions and Continued Regulatory Authority in Agreement States 

26 and in Offshore Waters under Section 274” 

27 10 CFR Part 170 “Fees for Facilities, Materials, Import and Export Licenses, and Other 

28 Regulatory Services 0nder the Atomic Energy Act of 1954, as Amended” 

29 10 CFR Part 171 “Annual Fees for Reactor Licenses, and Fuel Cycle Licenses and 

30 Materials Licenses, Including Holders of Certificates of Compliance, 

31 Registrations, and Quality Assurance Program Approvals and 

32 Government Agencies Licensed by the NRC” 

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

34 Customer Contact Center toll-free at 866-512-8600, in Washington, DC; calling 

35 202-512-1800; or ordering online at http://bookstore.gpo.gov. 
4-2 

1 In addition, 10 CFR Parts 1 through 199 can be found on the NRC’s Web site at 

2 http://www.nrc.gov/reading-rm/doc-collections/ under “Regulations (10 CFR).” 

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

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

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

6 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 the 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 (10 CFR) 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, Futura. 

8  Use an 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 corporate officer thereof, as 

required by 10 CFR 70.22(d) (see Section 8.13, “Certification”). 

13 5.4 Electronic Applications 

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

15 Exchange, or CD-ROM. Detailed guidance on making electronic submissions can be obtained 

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

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

18 signatures, and the 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. Licensing applications that contain sensitive information 

8 should be marked as indicated below in accordance with Title 10 of the Code of Federal 

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

10 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 O includes a checklist for 

15 requests for withholding 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 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 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 Regulatory 

41 Issue Summary 2005-31, “Control of Security-Related Sensitive Unclassified Non42 Safeguards Information Handled by Individuals, Firms, and Entities Subject to NRC 

43 Regulation of the Use of Source, Byproduct, and Special Nuclear Material,” dated 

44 December 22, 2005, which can be found on the NRC’s Generic Communications Web 

45 page under “Regulatory Issue Summaries”: http://www.nrc.gov/reading-rm/doc-
6-2 

1 collections/gen-comm/. Additional information on procedures and any updates is 

2 available at http://www.nrc.gov/reading-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 intragency 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, or 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: 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: 

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; for example, 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 (10 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 

18 the Office of the Chief Financial Officer at NRC Headquarters in Rockville, MD, 301-415-7554. 

19 Information about fees may also be obtained by calling NRC’s toll-free number, 800-368-5642, 

20 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 the U.S. Nuclear Regulatory 

3 Commission (NRC) Form 313 (Appendix A of this 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 Regulations (10 CFR) 20.1101(b) states, “The licensee shall 

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

12 protection principles to achieve occupational doses and doses to members of the public that are 

13 as low as is reasonably achievable (ALARA).” Regulatory Guide 8.10, Rev. 2, “Operating 

14 Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably 

15 Achievable,” discusses the ALARA concept and philosophy. The application should document 

16 ALARA considerations, including establishing administrative action levels and monitoring 

17 programs. 

18 10 CFR 20.1406, “Minimization of contamination,” requires applicants for licenses to describe 

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

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

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

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

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

24 requirements in 10 CFR 20.1801, “Security of store material,” and 10 CFR 20.1802, “Control of 

25 material not in storage.” 

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

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

28 8.1 Item 1: License Action Type 

29 Item 1 of NRC Form 313 states the following: 

30 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 

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

32 issuance of the license. Also note that an initial security inspection may be conducted in 

33 accordance with NRC Inspection Manual Chapter 2800, “Materials Inspection Program,” before 

34 issuance of the license. 
8-2 

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

2 Check Box C for a renewal of an existing license and provide the license number. See “License 

3 Amendments and Renewals” in Chapter 9 of this NUREG. 

4 8.2 Item 2: Name and Mailing Address of Applicant 

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

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

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

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

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

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

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

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

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

14 be notified when bankruptcy proceedings have been initiated (see Section 8.2.1, “Notification of 

15 Bankruptcy Proceedings”). 

16 8.2.1 Notification of Bankruptcy Proceedings 

17 Regulation: 10 CFR 70.32(a)(9) 

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

19 or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in 

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

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

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

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

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

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

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

27 bankruptcy actions are completed, and the NRC may request that the U.S. Department of 

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

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

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

31 involuntary petition for bankruptcy by or against the licensee. 

32 Reference: See NUREG–1556, Volume 15, “Consolidated Guidance About Materials Licenses: 

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

34 Special Nuclear Materials Licenses.” 

35 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or 

36 Possessed 

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

38 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each 
8-3 

1 facility. The descriptive address should be sufficient to allow an NRC inspector to find the 

2 facility location. A post office box address is not acceptable (see Figure 8-1). In addition, 

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 

3 applicants are encouraged to provide global positioning system (GPS) coordinates, as 

4 appropriate. A license amendment is required before receiving, using, or storing licensed 

5 material at an address or location not already listed on the license. 

6 To conduct operations at temporary job sites (i.e., locations where work is conducted for limited 

7 periods of time), the address may be stated as “temporary job sites anywhere in the United 

8 States where the NRC maintains jurisdiction.” 

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

10 amount of radioactive material, the applicant should mark these documents as “Security Related 

11 Information—Withhold under 10 CFR 2.390.” See Chapter 6, “Identifying and Protecting 

12 Sensitive Information,” for more details. 

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

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

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

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

17 is terminated). Acceptable records are sketches, written descriptions of the specific locations or 

18 room numbers where special nuclear material was used or stored, and any records or 

19 information relevant to damaged devices or leaking radioactive sources, or other unusual 

20 occurrences involving the possible spread of contamination in or around the licensee’s facilities. 

RPh17a.ppt

082898

32 Elm St.

City, ST 12345 P.O. Box XXXX

City, ST 12345

32 ELM St.

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

State, or local regulations (e.g., local zoning requirements). 
8-4 

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. Also include 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. 

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

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

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

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

12 8.5 Item 5: Radioactive Material 

13 8.5.1 Sealed Sources and Devices or Unsealed Radioactive Material 

14 Regulations: 10 CFR 20.2207, 10 CFR Part 37, 10 CFR 70.22, 10 CFR 70.23, 10 CFR 70.39 

15 Criteria: An application for a license will be approved if the requirements of 10 CFR 70.23, 

16 “Requirements for the approval of applications,” are met. In addition, licensees will be 

17 authorized to possess and use only those sources and devices that are specifically approved or 

18 registered by NRC or an Agreement State. Licensees must also protect aggregated Category 1 

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

20 diversion, and sabotage. 

21 Discussion: Each authorized radioisotope is listed on the NRC license by its element name, 

22 chemical and/or physical form, and the maximum possession limit. Table 8-1 below shows the 

23 type of radioactive material covered by this NUREG. 

Table 8-1. Types of Radioactive Materials 

Type of Material 

Covered By 

This Report Examples 

Byproduct (reactor-produced) No H-3, C-14, I-131, I-125, S-35, P-32, P-33, 

Ca-45, Ni-63, Cd-109, Cs-137 

Source material No U, Th 

Special nuclear material Yes U-233, U-235, and Pu 

Naturally occurring radioisotopes No Ra-226 

Accelerator-produced radioisotopes No Co-57, Na-22, Tl-201, Ga-67 
8-5 

1 The applicant should list each requested radioisotope by its element name and its mass number 

2 [e.g., uranium-233 (U-233)] in item 5. Identify the chemical and physical form of each requested 

3 radioisotope. Identify the quantities of material in milligrams (mg) or grams (g), and microcuries. 

4 If applicable, identify the percent enrichment of uranium-235 (U-235). If applicable, identify the 

5 National Sealed Source and Device Registry (NSSDR) number. 

6 Note: Applicants seeking authorization to use a sealed source and device, without an 

7 associated NSSDR registry number, issued by the NRC or Agreement State, should submit all 

8 of the applicable procedures and information as described in 10 CFR 70.39. Lacking this 

9 information, the encapsulated source will be regulated as unsealed radioactive material until the 

10 applicant provides sufficient safety-related information demonstrating that the source can be 

11 licensed as a sealed source. 

12 Applicants requesting an authorization to use unsealed radioactive material, including volatile, 

13 aerosol, or fine-particulate forms, must provide appropriate facilities, engineering controls, and 

14 radiation safety procedures for handling of such material. 

15 The anticipated possession limit in milligrams (or grams), percent enrichment, and microcuries 

16 for each radioisotope should also be specified. Possession limits must cover the total 

17 anticipated inventory, including licensed material in storage and waste, and should be 

18 commensurate with the applicant’s needs and facilities for safe handling. Applicants should 

19 review the requirements for submitting a certification for financial assurance for 

20 decommissioning before specifying possession limits of any radioisotope with a half-life greater 

21 than 120 days. These requirements are discussed in Section 8.5.2, “Financial Assurance and 

22 Recordkeeping for Decommissioning.” 

23 A safety evaluation of sealed sources and devices may have been performed by the NRC or an 

24 Agreement State that authorizes a manufacturer (or distributor) to distribute the sealed source 

25 and device to specific or general licensees. The safety evaluation is documented in a Sealed 

26 Source and Device (SSD) Registration Certificate. Information on SSD registration certificates 

27 may be obtained by contacting the U.S. Nuclear Regulatory Commission, Materials Safety 

28 Licensing Branch, Division of Material Safety, State, Tribal, and Rulemaking Programs, 

29 Washington, DC 20555-0001. Guidance on the SSD registration process is provided in 

30 NUREG–1556, Volume 3, “Consolidated Guidance on Materials Licenses: Applications for 

31 Sealed Source and Device Evaluation and Registration.” If applicable, the license applicant 

32 should identify the manufacturer’s name and model number for each requested sealed source 

33 and device so that the NRC can verify that they have been evaluated in an SSD Registration 

34 Certificate or specifically approved on a license. 

35 Consult with the proposed supplier, manufacturer, or distributor to ensure that requested 

36 sources and devices are compatible with and conform to the sealed source and device 

37 designations registered with the NRC or an Agreement State. Licensees may not make any 

38 changes to the sealed source, device, or source/device combination that would alter the 

39 description or specifications from those indicated in the respective registration certificates 

40 without obtaining the NRC’s prior permission in a license amendment. To ensure that 

41 applicants use sources and devices according to the registration certificates, they may want to 

42 get a copy of the certificate and review it or discuss it with the manufacturer. Applicant and 

43 licensee information on manufacturers, model numbers, and possession limits is sensitive and 

44 should be marked accordingly (see Chapter 6, “Identifying and Protecting Sensitive 

45 Information”). 
8-6 

Certain types of special nuclear material less that critical mass sources can be at or above 

Category 2 quantities of radioactive material. “Category 2 quantity of radioactive material” is 

defined in 10 CFR 37.5, and the radionucluides referenced in the 10 CFR 37.5 definition is listed 

in Appendix A to 10 CFR Part 37. See Section 8.10.11.2, “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. 

1 Response from Applicant: 

2  For unsealed materials: 

3 — Provide element name with mass number, chemical and/or physical form, and 

4 maximum requested possession limit in milligrams (or grams), percent 

5 enrichment, and microcuries for each radioisotope. 

6  For sealed sources: 

7 — Identify each radionuclide (element name and mass number) that will be used 

8 and specify the maximum quantity [mass in milligrams (or grams)], percent 

9 enrichment, and microcuries per source. Also, specify the maximum number of 

10 sources or total quantity for each radionuclide. 

11 — Provide the manufacturer’s (distributor’s) name and model number for each 

12 sealed source and device requested. 

13 — Confirm that each sealed source, device, and source/device combination is 

14 registered as an approved sealed source or device by the NRC or an Agreement 

15 State. 

16 — Confirm that the activity per source and maximum quantity in each device will not 

17 exceed the maximum quantity listed on the approved certificate of registration 

18 issued by the NRC or by an Agreement State. 

19  For unregistered sealed sources: 

20 — Identify each radionuclide (element name and mass number) that will be used 

21 and specify the maximum quantity [mass in milligrams (or grams)], percent 

22 enrichment, and microcuries per source. Also, specify the maximum number of 

23 sources or total quantity for each radionuclide. 

24 — Source drawings, the form of the source itself, its containment structure, and a 

25 hazards analysis (e.g., what is the annual limit of intake for the source) should be 

26 provided for any sources not registered in the SS&DR; 

27 — Clear limitations on the use of the source. 

28 — Confirm that the activity per source and maximum quantity will not exceed the 

29 maximum quantity requested. 

30  Provide an emergency plan (if required). 
8-7 

1 8.5.2 Financial Assurance and Recordkeeping for Decommissioning 

2 Regulations: 10 CFR 70.22(a)(9), 10 CFR 70.25, 10 CFR 70.38, 10 CFR 70.51 

3 Criteria: A licensee authorized to possess licensed material in excess of the limits specified in 

4 10 CFR 70.25, “Financial assurance and recordkeeping for decommissioning,” must submit 

5 a decommissioning funding plan (DFP) or provide a certification of financial assurance 

6 for decommissioning. 

7 All licensees are required by 10 CFR 70.25(g) to maintain records of information important to 

8 the decommissioning of the facility in an identified location until the site is released for 

9 unrestricted use. Licensees must transfer these records either to the new licensee before 

10 licensed activities are transferred or assigned in accordance with 10 CFR 70.51(b)(3), or to the 

11 appropriate NRC regional office before the license is terminated. 

12 Financial Assurance 

13 Discussion: NRC regulations requiring financial assurance or a DFP are designed to provide 

14 reasonable assurance that the technical and environmental components of decommissioning 

15 are carried out and unrestricted use of the facilities is possible at the conclusion/termination of 

16 licensed activities. These requirements, if applicable, specify that a licensee either set aside 

17 funds for decommissioning activities or provide a guarantee through a third party that funds will 

18 be available (see Figure 8-2). Applicants are required to submit financial assurance or a DFP 

19 when the license authorizes possession of radioactive material of half-life (T1/2) greater than 

20 120 days and exceeds certain limits. Criteria for determining whether an applicant is required to 

21 submit a DFP or financial assurance (or neither) are stated in 10 CFR 70.25. Applicants should 

22 consider encapsulated sources and certain custom sources as unsealed material if it is not 

23 registered in the sealed source and device registry. See 10 CFR 70.25 (b) regarding the DFP 

24 or financial assurance for decommissioning for unsealed SNM.

25 The NRC wants to ensure that decommissioning will be carried out with minimum impact on the 

26 public, occupational health and safety, and the environment (53 FR 24018; June 27, 1988). 

27 There are two parts to this decommissioning rule: financial assurance that applies to some

28 licensees and recordkeeping that applies to all licensees. 

Figure 8-2. Methods of Certification of Financial Assurance for Decommissioning 
8-8 

1 NUREG–1757, Volume 3, “Consolidated Decommissioning Guidance: Financial Assurance, 

2 Recordkeeping, and Timeliness,” provides a comprehensive listing of financial assurance 

3 mechanisms, including (i) Trust Fund, (ii) Surety Bond, (iii) Letter of Credit, (iv) Insurance Policy, 

4 (v) Parent Company Guarantee, (vi) Self-Guarantee, (vii) External Sinking Fund, (viii) Statement 

5 of Intent, or (ix) Special Arrangements with a government entity that assumes custody and 

6 ownership of the site. 

7 Recordkeeping for Decommissioning 

8 The requirements for maintaining records important to decommissioning, including the type of 

9 information required, are stated in 10 CFR 70.25(g). All licensees are required to maintain 

10 these records in an identified location until the site is released for unrestricted use 

11 (see Figure 8-3). Before the licensed activities are transferred or assigned in accordance with 

12 10 CFR 70.36 to another person or entity, these records shall be transferred to the new 

13 proposed licensee prior to transfer of the licensed activities under 10 CFR 70.51(b). The new 

14 licensee is responsible for maintaining these records until the license is terminated. Also, 

15 before a license is terminated, these records shall be transferred to the appropriate NRC 

16 regional office in accordance with 10 CFR 70.51(a). 

Figure 8-3. Types of Records That Must be Maintained for Decommissioning 

10 CFR 70.25(g), Requirements for Disposition of Records Important to 

Decommissioning

 Before licensed activities are transferred or assigned according to 10 CFR 70.42(b), transfer 

to the new licensee. 

OR 

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

1556-005.ppt

041300

Structural

Modifications As-built

Drawings

Surveys

Reference:

Blueprints stored

at Location XYZ

Spills

Deco

R

mmissioning

ecords

1556-005.ppt

041300

Structural

Modifications As-built

Drawings

As-built

Drawings

Surveys

Reference:

Blueprints stored

at Location XYZ

Spills

Deco

R

mmissioning

ecords
8-9 

1 Response from Applicants: No response is needed from most applicants requesting only 

2 sealed sources. However, if financial assurance or a DFP is required, submit the following: 

3  State the following: “Pursuant to 10 CFR 70.25(g) and 10 CFR 70.51, we will maintain 

4 records important to decommissioning and transfer these records to the appropriate 

5 NRC Regional Office or Agreement State before the license is terminated” 

6 AND 

7  If financial assurance is required, submit evidence of financial assurance following the 

8 guidance of NUREG–1757, Volume 3, “Consolidated Decommissioning Guidance: 

9 Financial Assurance, Recordkeeping, and Timeliness.” 

10 References: See the Notice of Availability on the inside front cover of this report to obtain 

11 copies of these documents: 

12 Regulatory Guide 3.65, “Standard Format and Content of Decommissioning Plans for Licensees 

13 Under 10 CFR Parts 30, 40, and 70” 

14 NUREG–1757, Volume 3, “Consolidated Decommissioning Guidance: Financial Assurance, 

15 Recordkeeping, and Timeliness” 

16 8.6 Item 6: Purpose(s) for Which Licensed Material Will be Used 

17 Regulations: 10 CFR 70.23(a)(1), 10 CFR 70.22(a)(2), 10 CFR 70.4 

18 Criteria: The possession or use of requested radioisotopes must be authorized by the Atomic 

19 Energy Act of 1954, as amended. All sealed sources and devices containing licensed material 

20 shall be used only for the purpose for which they are designed, and according to manufacturer’s 

21 (distributor’s) instructions and recommendations for use as specified in the SSD Registration 

22 Certificate. 

23 Discussion: Applicants should clearly specify the purpose for which each radioisotope will be 

24 used and a general plan for carrying out the activity should be described. Each individual use 

25 should be described. 

26 A typical license authorizes persons to perform research and development and student 

27 instruction using plutonium/beryllium (Pu/Be) sealed sources in a neutron howitzer, experiments 

28 using subcritical assemblies, calibration of radiation-detection instruments and others described 

29 in Section 1.0. Nontypical uses will be evaluated on a case-by-case basis, and the authorized 

30 use condition will reflect approved uses. 

31 The described uses should contain sufficient information to enable the reviewers to have a clear 

32 understanding of each use and determine the potential for exposure of workers and members of 

33 the public to radiation and radioactive materials. 

34 Response from Applicant: List the specific use or purpose of each radioisotope. 
8-10 

1 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and 

2 Their Training Experience 

3 8.7.1 Radiation Safety Officer (RSO) 

4 Regulation: 10 CFR 20.1101, 10 CFR 70.22(a)(6), and 10 CFR 70.23(a)(2) 

5 Criteria: RSOs must have training and specific experience appropriate for the types and 

6 quantities of licensed material to be authorized on the license. 

7 Discussion: The person responsible for implementing the radiation protection program is 

8 called the RSO. The RSO should have independent authority to stop operations that he or she 

9 considers unsafe. He or she should have sufficient time and commitment from management to 

10 fulfill certain duties and responsibilities to ensure that radioactive materials are used in a safe 

11 manner. Typical RSO duties are illustrated in Figure 8-4 and described in Appendix C of this 

12 NUREG. 

Figure 8-4. RSO Responsibilities 

 Typical duties and responsibilities of RSOs 

13 The NRC believes that to demonstrate adequate training and experience, the RSO should have 

14 (i) sufficient knowledge of physical, chemical, biological sciences, or engineering, and 

15 (ii) training and experience commensurate with the scope of proposed activities. Training 

16 should include the following subjects: 

17  radiation protection principles 

18  characteristics of ionizing radiation 

19  units of radiation dose and quantities 

20  radiation detection instrumentation 

1556-030.ppt

041300

Stop unsafe activities

Supervise 

decontamination

Ensure security

Control disposal

Interact with NRC, 

other authorities

Maintain records

Audit program annually

Perform surveys

Train personnel

Investigate abnormal

events

For Licensed Materials

name

RSO

1556-030.ppt

041300

Stop unsafe activities

Supervise 

decontamination

Ensure security

Control disposal

Interact with NRC, 

other authorities

Maintain records

Audit program annually

Perform surveys

Train personnel

Investigate abnormal

events

For Licensed Materials

name

RSO

Stop unsafe activities

Supervise 

decontamination

Ensure security

Control disposal

Interact with NRC, 

other authorities

Maintain records

Audit program annually

Perform surveys

Train personnel

Investigate abnormal

events

For Licensed Materials

name

RSO
8-11 

1  biological hazards of exposure to radiation (appropriate to types and forms of special 

2 nuclear material to be used) 

3  NRC regulatory requirements and standards 

4  hands-on use of radioactive materials 

5 The length of training and experience described above will depend upon the type, form, 

6 quantity, and proposed use of the licensed material requested. Ultimately, the proposed RSO’s 

7 training and experience should be sufficient to identify and control the anticipated radiation 

8 hazards. 

9 Response from Applicant: Provide the following: 

10  name of the proposed RSO 

11  information demonstrating that the proposed RSO is qualified by training and 

12 experience. 

Applicants should provide information about the proposed RSO’s training and experience 

relative to the licensed material requested in the application. Applicants should not submit 

extraneous information, such as unrelated lists of publications, research grants, and 

committee and society memberships. The applicants should identify, mark, and protect 

sensitive information against unauthorized disclosure to the public and refrain from submitting 

PII when possible (See Chapter 6, “Identifying and Protecting Sensitive Information,” of this 

document). Submittal of unrelated material serves only to slow the review process. 

13 Note: Notify the NRC and obtain a license amendment before making changes in the 

14 designation of the RSO listed on the license. The name and qualifications of the replacement 

15 RSO must be submitted to the NRC as part of an amendment request. 

16 8.7.2 Authorized Users and Radiation Workers 

17 Regulations: 10 CFR 19.11, 10 CFR 19.12, 10 CFR19.13, 10 CFR 20.1101, 

18 10 CFR 70.22(a)(6), and 10 CFR 70.23(a)(2) 

19 Criteria: Authorized users (AUs), including radiation workers working under their supervision, 

20 must have adequate training and experience to safely possess and use licensed 

21 radioactive materials. 

22 An AU is a person (defined in 10 CFR 70.4) who, before using licensed material, is qualified by 

23 reason of training and experience to use the radioactive material for the purpose requested in 

24 accordance with the regulations of 10 CFR 70.22(a)(6) and 10 CFR 70.23(a)(2). 

25 Radiation workers must receive instruction commensurate with their duties and responsibilities, 

26 as required by 10 CFR 19.12, “Instruction to workers,” for individuals whose assigned duties 

27 involve exposure to radiation or radioactive material, and individuals who in the course of their 

28 employment are likely to receive in a year an occupational dose of radiation greater than 

29 1 millisievert (mSv) [100 millirem (mrem)]. 
8-12 

1 For the purposes of discussion in this NUREG, the applicant (and members of the applicant’s 

2 staff) will be denoted as AU. An AU is a person (defined in 10 CFR 70.4) who, before using 

3 licensed material, is qualified by reason of training and experience to use the radioactive 

4 material for the purpose requested in accordance with the regulations of 10 CFR 70.22(a)(6) 

5 and 10 CFR 70.23(a)(2). 

6 Examples of the training and experience, which will be reviewed and authorized by the NRC 

7 during licensing actions, such as new licenses and amendments and/or renewals to existing 

8 NRC licenses are described in the discussion paragraphs. 

9 Discussion: An AU (also known as “principal investigator”) is a person whose training and 

10 experience have been reviewed and approved by the NRC, who is named on the license, and 

11 who uses or directly supervises the use of licensed material. The AU’s primary responsibility is 

12 to ensure that radioactive materials used in his or her particular lab or area, are used safely and 

13 according to regulatory requirements (See Figure 8-5). The AU also is responsible for ensuring 

14 that procedures and engineering controls are used to keep occupational doses and doses to 

15 members of the public ALARA. 

Figure 8-5. Authorized User 

The authorized user is responsible for the safe use of licensed material in his or 

her laboratory or area. 

16 The NRC expects that AUs will have adequate and appropriate training to provide reasonable 

17 assurance that they will use licensed material safely, including maintaining security of, and 

18 access to, licensed material, and respond appropriately to events or accidents involving 

19 licensed material to prevent the spread of contamination. 

20 The NRC believes that to demonstrate adequate training and experience, the AU should have 

21 (i) sufficient knowledge of physical, chemical, biological sciences, or engineering, and 

22 (ii) training and experience commensurate with the scope of proposed activities. Training 

23 should include the following topics: 

24  radiation protection principles 

1556-031.ppt

041300

RSO

Radioactive 

Waste

Radioactive 

Waste
8-13 

1  characteristics of ionizing radiation 

2  units of radiation dose and quantities 

3  radiation detection instrumentation 

4  biological hazards of exposure to radiation (appropriate to the types and forms of special 

5 nuclear material to be used) 

6  hands-on use of radioactive materials 

7 The length of training and experience described above will depend upon the type, form, 

8 quantity, and proposed use of the licensed material requested. 

9 An AU is considered to be supervising the use of radioactive materials when the AU is directing 

10 personnel in operations involving the licensed material. Although the AU may delegate specific 

11 tasks to supervised users (e.g., conducting surveys, keeping records), the AU is responsible for 

12 the safe use of radioactive material to assure that areas are not contaminated. 

13 Applicants should name at least one qualified authorized user. In general, AUs should 

14 demonstrate training and experience with the type and quantity of material that they propose to 

15 use. For example, someone with training and experience only with sealed radioactive sources 

16 may not be qualified to use or supervise the use of unsealed licensed material. In addition, 

17 someone with experience using only trace quantities may not understand the risks of working 

18 with much larger (e.g., 10 or more times larger) quantities of the same substance. Applicants 

19 should pay particular attention to the type of radiation involved. For example, someone 

20 experienced with gamma emitters may not have appropriate experience for high energy 

21 beta emitters. 

22 Training may be in the form of lecture, demonstrations, videotape, or self-study and should 

23 emphasize practical subjects important to the safe use of licensed material. Emergency drills 

24 should be conducted on the likely scenarios that may be encountered. The guidance in 

25 Appendix M of this NUREG may be used to develop a training program. The program should 

26 consider both the topics pertinent for each group of workers and the method and frequency of 

27 training. 

28 Response from Applicant: Provide the following: 

29  name of each proposed AU with the types and quantities of licensed material to be used

30 AND 

31  information demonstrating that each proposed AU is qualified by training and experience 

32 to use the requested licensed materials. 
8-14 

Applicants should provide information about the proposed AU’s training and experience 

relative to the licensed material requested in the application. Applicants should not submit 

extraneous information, such as unrelated lists of publications, research grants, committee 

and society memberships, etc. The applicants should identify, mark, and protect sensitive 

information against unauthorized disclosure to the public and refrain from submitting PII when 

possible (See Section 6, “Identifying and Protecting Sensitive Information,” of this document). 

Submittal of unrelated material serves only to slow the review process. 

1 

2 AND/OR 

3  The statement: “Before using licensed material, authorized users will receive the 

4 training described in Appendix M in NUREG–1556, Volume 17, Revision 1, 

5 “Consolidated Guidance About Materials Licenses: Special Nuclear Material of Less 

6 Than Critical Mass Licenses.” 

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

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

9 Areas (Instructions to Occupationally Exposed Workers and Ancillary 

10 Personnel) 

11 Regulations: 10 CFR 19.12, 10 CFR 19.13, 10 CFR 37.43, 10 CFR 70.7, 10 CFR 70.10, 

12 10 CFR 70.23(a)(2) 

13 Criteria: Individuals whose assigned duties involve exposure to radiation or radioactive 

14 material (from both licensed and unlicensed sources), and in the course of their employment are 

15 likely to receive in a year an occupational dose of radiation greater than 1 millisievert (mSv) 

16 [100 millirem (mrem)], must receive instruction commensurate with their duties and 

17 responsibilities, as required by 10 CFR 19.12, “Instruction to workers.” Also, any licensee that 

18 possesses an aggregated Category 1 or Category 2 quantity of radioactive material (as defined 

19 in 10 CFR 37.5) must implement a training program for those individuals implementing the 

20 security program. 

21 Discussion: Before beginning work with licensed material, individuals must receive radiation 

22 safety training commensurate with their assigned duties and specific to the licensee’s radiation 

23 safety program. Each individual also should receive periodic refresher training. 

24 Licensees should not assume that safety instruction has been adequately covered by prior 

25 employment or academic training. Site-specific training should be provided for all individuals. 

26 Particular attention should be given to persons performing work with radioactive materials that 

27 may require special procedures, such as hot cell work and waste processing. Also, ancillary 

28 personnel (e.g., clerical, housekeeping, security), whose duties may require them to work in the 

29 vicinity of radioactive material (whether escorted or not), need to be informed about radiation 

30 hazards and the appropriate precautions. The licensee should assess each individual’s 

31 involvement with licensed material and cover each applicable subject appropriately. 

32 Training may be in the form of lecture, demonstrations, videotape, or self-study and should 

33 emphasize practical subjects important to the safe use of licensed material. The program 
8-15 

1 should consider both the topics pertinent for each group of workers and the method and 

2 frequency of training. 

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

4 the qualifications for an RSO or AU on the license and is familiar with the licensee’s program). 

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 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. 

5 Response from Applicant: A description of the radiation safety training program, including 

6 topics covered, groups of workers, assessment of training, qualifications of instructors, and the 

7 method and frequency of training. 

8 8.9 Item 9: Facilities and Equipment 

9 Regulations: 10 CFR 20.1101, 10 CFR 20.1406, 10 CFR Part 37, 10 CFR 37.5, 

10 10 CFR 37.49, 10 CFR 37.53, 10 CFR 70.22(a)(7), 10 CFR 70.23(a)(3), 10 CFR 70.25(g), 

11 10 CFR 70.41(a)

12 Criteria: Facilities and equipment must be adequate to protect health and minimize danger to 

13 life or property and provide enhanced physical protection of aggregated Category 1 and 

14 Category 2 quantities of radioactive material, as defined in 10 CFR 37.5. Applicants must 

15 describe how facility design and procedures for operation will minimize, to the extent 

16 practicable, contamination of the facility and the environment, facilitate eventual 

17 decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. 

18 Discussion: Applicants must demonstrate that their facilities and equipment provide sufficient 

19 engineering controls and barriers to protect the health and safety of the public and its 

20 employees, keep exposures to radiation and radioactive materials ALARA, and minimize the 

21 danger to life and property from the uses of the types and quantities of radioactive materials to 

22 be used. These requirements are addressed in 10 CFR Part 20, Subpart E. Specifically, 

23 10 CFR 20.1402, “Radiological criteria for unrestricted use,” specifies that a site will be 

24 considered acceptable for unrestricted use if the residual radioactivity that is distinguishable 

25 from background radiation results in a TEDE to an average member of the critical group that 

26 does not exceed 25 mrem [0.25 mSv] per year, including that from groundwater sources of 
8-16 

1 drinking water, and the residual radioactivity has been reduced to levels that are ALARA. 

2 Determination of the levels that are ALARA must take into account consideration of any 

3 detriments, such as deaths from transportation accidents, expected to potentially result from 

4 decontamination and waste disposal. 

5 Applicants requesting authorization for an unregistered or custom sealed source should provide 

6 adequate information on facilities, equipment, operating and emergency procedures associated 

7 with a risk-based assessment of the containment structure. 

8 Applicants may delay completing facilities and acquiring equipment until after the application 

9 review is completed, in case changes are required as a result of the application review. This 

10 also helps ensure the adequacy of the facilities and equipment before the applicant makes a 

11 significant financial commitment. In all cases, the applicant cannot possess or use radioactive 

12 material until after the facilities are approved and completed, equipment is procured and ready 

13 for use, and the license is issued. 

14 Applicants are reminded that records important to decommissioning include the following: 

15  as-built drawings and modifications of structures and equipment in restricted areas 

16  as-built drawings and modifications of locations of possible inaccessible contamination 

17 such as buried pipes that may be subject to contamination 

18  records of spills and unusual occurrences that may result in contamination of the facility 

19 or site 

20 These records are required to be maintained in an identifiable location under 10 CFR 70.25(g). 

21 Facilities are required to meet NRC criteria prior to release for unrestricted use. Therefore, 

22 careful facility design is important to prevent contamination, facilitate decontamination, and 

23 reduce the costs needed for decommissioning. For further information, see Section 8.5.2, 

24 “Financial Assurance and Recordkeeping for Decommissioning.” 

25 For additional guidance regarding facilities and equipment, refer to Appendix D of this NUREG. 
8-17 

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 submitted to the NRC, but may 

be subject to review and inspection.

1 Response from Applicant: Describe the facilities and equipment to be made available at each 

2 location where radioactive material will be used. Include a description of the area(s) assigned 

3 for the receipt, storage, security, preparation, and measurement of radioactive materials. 

4 A diagram should be submitted showing the locations of shielding, the proximity of radiation 

5 sources to unrestricted areas, and other items related to radiation safety. When applicable to 

6 facilities where radioactive materials may become airborne, the diagrams should contain 

7 schematic descriptions of the ventilation systems, with pertinent airflow rates, pressures, 

8 filtration equipment, and monitoring systems. Diagrams should be drawn to a specified scale, or 

9 dimensions should be indicated. For facilities where it is anticipated that more than one 

10 laboratory or room may be used, a generic laboratory or room diagram may be submitted. Also 

11 describe procedures for control, review, and approval of significant facilities or equipment 

12 modifications. 

13 

14 Reference: For further information on facility design, see Chapter 4 of NCRP Report No. 127, 

15 “Operational Radiation Safety Program.” 

16 

17 8.10 Item 10: Radiation Safety Program 

18 Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 30.33 
8-18 

1 Criteria: A radiation safety program should be established by the applicant. The program 

2 should be commensurate with the scope and extent of activities for the use of licensed materials 

3 in self-shielded irradiators. Each applicant for a self-shielded irradiator license should develop, 

4 document, and implement a radiation protection program containing the following elements: 

5  steps to keep radiation exposures ALARA 

6  description of equipment and facilities adequate to protect personnel, the public, and 

7 the environment 

8  conduct of licensed activities by individuals qualified by training and experience 

9  written operating and emergency procedures to address all likely scenarios 

10  description of the organizational structure and of the individuals responsible for ensuring 

11 implementation of the radiation safety and security program 

12  records management 

13  implementation of an audit program to ensure that the radiation safety and security 

14 program are reviewed at least annually 

15 Discussion: The specific components of the applicant’s radiation safety and security program 

16 are detailed as separate topics in the remainder of this section. Some topics do not require a 

17 response from an applicant but are intended to provide guidance to the applicant on acceptable 

18 methods of compliance with specific NRC requirements. 

19 8.10.1 Audit and Review of Program 

20 Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 21.21(a), 10 CFR 37.33, 

21 10 CFR 37.55

22 Criteria: Licensees must review the content and implementation of their radiation protection 

23 programs at least annually to ensure the following: 

24  compliance with NRC and U.S. Department of Transportation (DOT) regulations 

25 (as applicable), and the terms and conditions of the license 

26  occupational doses and doses to members of the public are ALARA (10 CFR 20.1101, 

27 “Radiation protection programs”) 

28  access authorization program is effective and complies with 10 CFR Part 37, if required 

29  security program is effective and complies with 10 CFR Part 37, Subpart C, if required 

30  records of audits and other reviews of program content are maintained for 3 years 

31 Discussion: Appendix E of this NUREG contains a suggested audit program that is applicable 

32 to special nuclear material of less than critical mass licensees and is acceptable to the NRC. 

33 Since all areas indicated in Appendix E may not be applicable to every licensee and all items 
8-19 

1 may not need to be addressed during each audit, licensees may wish to develop a program2 specific audit checklist. 

3 The NRC encourages licensee management to conduct performance-based reviews by 

4 observing work in progress, interviewing staff, and spot-checking required records. As a part of 

5 the audit program, applicants should consider including unannounced audits of users of special 

6 nuclear material of less than critical mass to observe whether radiation safety procedures are 

7 being followed. Licensees should consider providing specialized audit training, if staff other 

8 than the RSO are used to conduct audits of the performance of radiographers and 

9 radiographer’s assistants. See Appendix E of this NUREG for applicable audit program areas 

10 for potential specialized training. 

11 It is essential that, once identified, problems are corrected comprehensively and in a timely 

12 manner. Information Notice (IN) 96-28, “Suggested Guidance Relating to Development and 

13 Implementation of Corrective Action,” provides guidance on this subject. The NRC routinely 

14 reviews licensee’s records to verify whether appropriate corrective actions were implemented in 

15 a timely manner to address recurrence. It is in the best interest of the licensee to identify 

16 potential violations of regulatory requirements and take necessary steps to correct them. The 

17 NRC can opt to exercise discretion and may elect not to cite the licensee for these violations if 

18 prompt and effective corrective actions are implemented. The NRC’s Enforcement Policy may 

19 be found online at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html and 

20 the Enforcement Manual may be found online at http://www.nrc.gov/about21 nrc/regulatory/enforcement/guidance.html. For examples of the NRC’s use of discretion in 

22 issuing a notice of violation, refer to the most recent version of NRC’s enforcement documents 

23 at http://www.nrc.gov/reading-rm/doc-collections/enforcement/.

24 Licensees must maintain records of audits and other reviews of program content and 

25 implementation for 3 years from the date of the record, in accordance with 10 CFR 20.2102. 

26 The NRC has found audit records that contain the following information acceptable: 

27  date of audit 

28  name of person or persons who conducted the audit 

29  names of persons contacted by the auditor or auditors 

30  areas audited 

31  audit findings and corrective actions 

32  follow-up 
8-20 

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 submitted to the NRC, but may 

be subject to review and inspection.

1 Response from Applicant: The applicant is not required to, and should not, submit its audit 

2 program to the NRC for review during the licensing phase. However, this information may be 

3 reviewed during NRC inspections. 

4 References: See the Notice of Availability on the inside front cover of this report to obtain 

5 copies of: 

6  Inspection Procedure 87110, Appendix A, “Industrial/Academic/Research Inspection 

7 Field Notes,” dated February 3, 1997 

8  Enforcement Policy, dated June 7, 2012 

9 (http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html) 

10  IN 96-28, “Suggested Guidance Relating to Development and Implementation of 

11 Corrective Action,” dated May 1, 1996 

12 The information above is available on the NRC Web site at http://www.nrc.gov/. 

13 8.10.2 Radiation Monitoring Instruments 

14 Regulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 70.22(a)(7)

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. 
8-21 

1 Discussion: Licensees shall possess, or have access to, calibrated radiation 

2 detection/measurement instruments or licensed services to perform, as necessary, 

3 the following: 

4  package surveys 

5  contamination surveys 

6  sealed source leak tests 

7  air sampling measurements 

8  bioassay measurements 

9  effluent release measurements 

10  unrestricted area dose rate measurements 

11 For the purposes of this document, survey instruments are defined as any device used to 

12 measure the radiological conditions at a licensed facility. Some of the survey instruments that 

13 may be used to perform the above functions include: 

14  portable or stationary count rate meters 

15  portable or stationary dose rate or exposure rate meters 

16  single or multichannel analyzers 

17  liquid scintillation counters (LSC) 

18  gamma counters 

19  proportional counters 

20  zinc sulfide (ZnS) detectors 

21  neutron detectors 

22  solid state detectors 

23 Other equipment and instrumentation associated with the radiation hazard assessment also 

24 should be periodically calibrated. This includes equipment used to collect radiological samples 

25 to perform assessments of airborne hazards, and other radiological hazards that cannot be 

26 directly assessed, such as: 

27  rotameters 

28  anemometers 

29  air pump flow rate or volumes 

30  liquid volume collection/measurement device 

31 The choice of instrument should be appropriate for the type of radiation to be measured, and for 

32 the type of measurement to be taken (e.g., count rate, dose rate). The majority of the 

33 radioactive emissions from special nuclear material are alpha emissions; therefore, the 

34 applicant’s instrumentation should include instrumentation capable of detecting alpha 

35 emissions, such as ZnS detectors. Applications should include descriptions of the 

36 instrumentation available for use and any instrumentation applicants intend to purchase prior to 

37 starting licensed activities. The description should include type of instrument and probe and the 

38 instrument’s intended purpose. 

39 Instruments used for qualitative surveys are only intended to detect contamination in the 

40 laboratory. Such instruments should be checked for operational response with an appropriate 

41 check source containing radioactive material, and can be calibrated with an electronic pulser 

42 instead of a radioactive source. However, these instruments cannot be used for measurement
8-22 

1 of surface contamination or radiation levels without a calibration with appropriate 

2 radioactive sources. 

3 Under 10 CFR 20.2103(a), the NRC requires that calibrations be performed by the instrument 

4 manufacturer or a person specifically authorized by the NRC or an Agreement State, unless the 

5 applicant specifically requests this authorization. Applicants seeking authorization to perform 

6 survey instrument calibrations shall submit procedures for review. Appendix F of this NUREG 

7 provides information about instrument specifications and model calibration procedures. 

8 Regardless of whether an applicant is authorized to calibrate radiation survey meters or 

9 contacts an authorized firm to perform calibrations, the licensee must retain records of the 

10 calibration of instruments and equipment used for quantitative radiation measurements for 

11 3 years after the record is made, in accordance with 10 CFR 20.2103(a). 

12 Response from Applicant: Provide one of the following: 

13  A description of the instrumentation (as described above) that will be used to perform 

14 required surveys and a statement that: “We will use instruments that meet the radiation 

15 monitoring instrument specifications published in Appendix F to the current version of 

16 NUREG–1556, Volume 17, ‘Program-Specific Guidance About Special Nuclear Material 

17 of Less Than a Critical Mass Licenses.’ We reserve the right to upgrade our survey 

18 instruments as necessary.” 

19 OR 

20  A description of the instrumentation (as described above) that will be used to perform 

21 required surveys and a statement that: “We will use instruments that meet the radiation 

22 monitoring instrument specifications published in Appendix F to the current version of 

23 NUREG–1556, Volume 17, ‘Program-Specific Guidance About Special Nuclear Material 

24 of Less Than a Critical Mass Licenses.’ Additionally, we will implement the model 

25 survey meter calibration program published in Appendix F to current version of 

26 NUREG–1556, Volume 17, ‘Program-Specific Guidance about Special Nuclear Material 

27 of Less Than a Critical Mass Licenses.’ We reserve the right to upgrade our survey 

28 instruments as necessary.” 

29 OR 

30  A description of alternative equipment or procedures for ensuring that appropriate 

31 radiation monitoring equipment will be used during licensed activities and that proper 

32 calibration and calibration frequency of survey equipment will be performed. Further, the 

33 statement, “We reserve the right to upgrade our survey instruments as necessary” 

34 should be added to the response. 

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

36 8.10.3 Material Receipt and Accountability 

37 Regulations: 10 CFR 20.1501(a), 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1906, 

38 10 CFR 20.2001, 10 CFR 20.2201, 10 CFR 20.2207, 10 CFR 37.49, 10 CFR 37.71, 

39 10 CFR 37.75, 10 CFR 37.77, 10 CFR 70.22(a)(8), 10 CFR 70.23(a)(4), 10 CFR 70.25(g), 

40 10 CFR 70.51, 10 CFR 70.56, 10 CFR 74.15, 10 CFR 75.34 
8-23 

1 Criteria: Licensees must do the following: 

2  Develop, implement, and maintain written procedures for safely opening packages. 

3  Develop, implement, and maintain procedures to ensure control and accountability of 

4 licensed material. 

5  Maintain records of receipt, transfer, and disposal of licensed material. 

6  Update transactions in the National Source Tracking System (NSTS), including 

7 performing annual inventory reconciliation, if applicable. 

8  Before transferring aggregated Category 1 or Category 2 quantities of radioactive 

9 material listed in Appendix A to 10 CFR Part 37, use NRC’s license verification system 

10 to verify that the recipient licensee is authorized to possess the radioactive material. 

11  Preplan, coordinate, and provide advance notification of shipment of Category 1 

12 quantities of radioactive material and coordinate shipment of Category 2 quantities of 

13 radioactive material listed in Appendix A to 10 CFR Part 37, if required. 

14 Discussion: Licensees must (1) track licensed materials from receipt to transfer to ensure 

15 accountability at all times; (2) identify when licensed material may be lost, stolen, or misplaced; 

16 and (3) ensure that the possession limit stated on the license is not exceeded. 

17 Licensees are further required to develop, implement, and maintain written procedures for safely 

18 receiving and opening packages in accordance with 10 CFR 20.1906, “Procedures for receiving 

19 and opening packages.” Some packages may require special procedures that take into 

20 consideration the type, quantity, or half-life of the nuclide being delivered. 

21 SNM licensees should provide their Reporting Identification Symbol (RIS) to their supplier. A 

22 RIS allows the applicant to report nuclear material information to the Nuclear Materials 

23 Management and Safeguards System (NMMSS) database. The RIS would allow the company 

24 to report an export, import, domestic shipment, domestic receipt, and annual physical inventory 

25 report of one gram or more of special nuclear materials (plutonium, U-233, or U-235 contained 

26 in enriched uranium) required by NRC regulation (10 CFR 150.16 and 17) or one kilogram or 

27 more of source material (natural uranium, depleted uranium, or thorium) required by NRC 

28 regulations (10 CFR 150.16 and 17) to be reported to NMMSS. An RIS can only be obtained 

29 after the NRC license is issued. Once the license is issued, the licensee should call NRC at 

30 800-368-5642 and ask for the Division of Fuel Cycle Safety and Safeguards, Material Control, 

31 and Accounting. In order to process the request to be assigned an RIS, the following 

32 information will be requested: NRC License Number, address where the material will be used 

33 and stored, business address of the licensee, and name and telephone number of a contact 

34 person. The NMMSS database applies to both NRC and Agreement State licensees. 

35 If applicants have materials that are nationally tracked sources, they should report them to the 

36 NSTS. Applicants that have less than critical mass and have plutonium sources (greater than 

37 16 Ci) or Pu/Be sources must report them to the NSTS. 

38 Licensees need to make arrangements to receive radioactive packages when they are delivered 

39 or to be notified when radioactive packages arrive at the carrier’s terminal so that the licensee 

40 can pick up the packages expeditiously. 
8-24 

1 In limited scope radiation safety programs, the RSO usually receives the incoming package 

2 directly from the carrier and performs all verification, surveying, opening, and documentation for 

3 inventory. The package is then delivered to the AU, or the AU retrieves the package from the 

4 RSO. If the package is transported over public roads by the licensee, it must be repackaged 

5 and transported in accordance with DOT regulations. 

6 If the package of licensed material is delivered to the licensed facility’s receiving department 

7 (Receiving), individuals working in that department should be trained to do the following: 

8  Identify the package as containing radioactive material by labeling and shipping papers. 

9  Segregate the package from other incoming items in a secured area until released by 

10 the RSO. 

11  Notify the RSO. 

12 When notified by receiving that a package of licensed material has arrived, the RSO or AU 

13 should retrieve the package and follow the safe opening procedures. 

14 NRC regulations in 10 CFR 20.1906(b) and (c) state the requirements for monitoring packages 

15 containing licensed material. These requirements are described in Table 8-2, below. 

Table 8-2. Package Monitoring Requirements (10 CFR 20.1906)

Package Contents Survey Type Survey Time* 

Damaged Licensed Material Radiation Level 

and Radioactive 

Contamination 

[§20.1906(b)(3)] 

As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Labeled 

(White I, Yellow II, 

Yellow III) 

Not Gas nor Special Form 

Greater Than Type A 

Radiation Level 

[§20.1906(b)(2)] 

and Radioactive 

Contamination 

[§20.1906(b)(1)] 

As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Labeled 

(White I, Yellow II, 

Yellow III) 

Gas or Special Form 

Greater Than Type A 

Radiation Level 

[§20.1906(b)(2)] 

As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Labeled 

(White I, Yellow II, 

Yellow III) 

Not Gas nor Special Form 

Less Than or Equal to Type A

Radioactive 

Contamination 

[§20.1906(b)(1)] 

As soon as practicable, 

but not later than 

3 hours after receipt of 

package 

Labeled 

(White I, Yellow II, 

Yellow III) 

Gas or Special Form 

Less Than or Equal to Type A

None 

[§20.1906(b)(1)] 

None 

 
8-25 

Not Labeled Licensed Material None 

[§20.1906(b)] 

None†

*Assumes packages are received during normal working hours. If packages are received outside of normal working 

hours, the licensee has 3 hours after the beginning of the next work day to perform the required surveys 

[§20.1906(c)]. 

†

Excepted packages and limited quantity packages received by many laboratories are required to have the 

appropriate identification number from the Hazardous Materials Table in 49 CFR 172.101 (i.e. “UN number”) on the 

outside of the box, identifying it as containing radioactive materials. It is good health physics practices to perform an 

incoming survey on these packages, even though transportation regulations do not require it.

1 Regulations in 10 CFR 20.1906(d) require that the licensee immediately notify the final delivery 

2 carrier and the NRC Operations Center at 301–816–5100 by telephone and the Administrator of 

3 the appropriate NRC Regional Office listed in Appendix D to 10 CFR Part 20, “Standards for 

4 Protection Against Radiation” when removable radioactive surface contamination exceeds the 

5 limits of 10 CFR 71.87(i); or external radiation levels exceed the limits of 10 CFR 71.47, 

6 “External radiation standards for all packages.” As illustrated in Figure 8-6, licensed materials 

7 must be tracked from “receipt to disposal” to ensure accountability and to ensure that 

8 possession limits listed on the license are not exceeded. 

Figure 8-6. Material Receipt and Accountability 

Licensees must maintain records of receipt, transfer, and disposal of 

 licensed material 

9 It is recognized that loss, theft, or misplacement of licensed material can occur; however, 

10 licensees must have in place an accountability and control system for promptly detecting losses 

11 of licensed material. 

12 Licensees that possess sealed sources are required to perform periodic inventories. The 

13 frequency of these inventories is normally established by license condition at intervals not to 

14 exceed 6 months; however, regulations may specify a different inventory frequency. Some 

15 sealed sources may not be in use or are rarely used and are placed in storage. In these cases, 

16 licensees should confirm that these sealed sources have not been disturbed at least every 

17 6 months. For aggregated Category 1 and Category 2 quantities of radioactive material, 

18 licensees must, according to 10 CFR 37.49(a)(1), continuously monitor and detect, without 

19 delay, all unauthorized entries into security zones. Additionally, for Category 1 quantities of 

20 radioactive material, 10 CFR 37.49(a)(3)(i) requires immediate detection of any attempted 

21 unauthorized removal of the radioactive material from the security zone. For Category 2 

22 quantities of radioactive material, 10 CFR 37.49(a)(3)(ii) requires weekly verification through 

1556-010a

041300

Material 

Accountability 

Program

Disposal or Transfer

Transfer

or

D

R

isposal

ecord

Receipt

Receipt

Record

RADIOACTIVE I

RADIOACTIVE I

1556-010a

041300

Material 

Accountability 

Program

Disposal or Transfer

Transfer

or

D

R

isposal

ecord

Receipt

Receipt

Record

RADIOACTIVE I

RADIOACTIVE I

Material 

Accountability 

Program

Disposal or Transfer

Transfer

or

D

R

isposal

ecord

Transfer

or

D

R

isposal

ecord

Receipt

Receipt

Record

Receipt

Record

RADIOACTIVE I

RADIOACTIVE I
8-26 

1 physical checks, tamper indicating devices, use, or other means to ensure that the radioactive 

2 material is present. 

3 With regard to unsealed licensed material, licensees use various methods (e.g., computer 

4 programs, manual ledgers, log books) to account for receipt, use, transfer, disposal, and 

5 radioactive decay. These methods help to ensure that possession limits are not exceeded. 

6 SNM licensees are required to comply with 10 CFR 74.15, “Nuclear material transaction 

7 reports,” and 10 CFR 75.34, “Inventory change reports.” These regulations require licensees to 

8 submit U.S. Department of Energy (DOE)/NRC Form 741. NUREG/BR-0006 Revision 7, 

9 “Instructions for Completing Nuclear Material Transaction Reports and Concise Note Forms,” 

10 provides step-by-step instructions for filling out the form. 

11 To ensure that only trained, experienced, and authorized individuals use or supervise the use of 

12 licensed material, the RSO should know who has requested an order of licensed material and 

13 the types and amounts of licensed materials requested. Control procedures should also be 

14 established for the procurement of licensed materials that may be obtained outside the normal 

15 channels (e.g., through the loan or other transfer of materials without purchase or through 

16 surplus). 

17 The NRC regulations applicable to transfers are stated in 10 CFR 70.42, “Transfer of special 

18 nuclear material.” Transfer of licensed materials within the facility may require special 

19 procedures to ensure proper control. In many facilities, pieces of laboratory equipment or 

20 components, including refrigerators and freezers, will become contaminated. Removal of these 

21 items for maintenance, repair, or disposal should also be carefully controlled. 

22 The NRC considers licensed material to become part of the licensee’s inventory at the time that 

23 it is received by the licensee, be it during normal working hours or after hours when delivered by 

24 the carrier in accordance with procedures established by the licensee. If through some error, 

25 the licensee receives material it is unauthorized to possess or receives quantities of material 

26 that would result in the total inventory being in excess of license possession limits, the licensee 

27 should place the package in secure storage and arrange for the return of these materials in a 

28 timely manner. If return of the materials is not possible, the licensee should contact the NRC 

29 regional office and request issuance of an expedited license amendment. The materials must 

30 not be used until the amendment is granted. 

31 Licensees are required under 10 CFR 20.1801 and 20.1802 to secure radioactive materials 

32 from unauthorized removal or access while in storage in controlled or unrestricted areas and to 

33 control and maintain constant surveillance over licensed material that is in a controlled or 

34 unrestricted area and is not in storage. Applicants should establish policies and procedures for 

35 ensuring accountability of licensed materials. Licensed materials should be tracked from receipt 

36 to transfer to ensure accountability at all times; to identify when licensed material may be lost, 

37 stolen, or misplaced; and to ensure that the possession limit stated on the license is not 

38 exceeded. 

39 Licensees must maintain records of receipt, use, transfer, and disposal (as waste) of all licensed 

40 material. Table 8-3 below lists each type of record and how long the record must be 

41 maintained. Other records such as transfer records could be linked to radioactive material 

42 inventory records. Receipt records should also document cases where excessive radiation 

43 levels or radioactive contamination were found on packages or containers of material received 

44 and describe the action taken. 
8-27 

Table 8-3. Record Maintenance 

Type of Record How Long Record Must be Maintained 

Receipt For as long as the material is possessed, for 3 years following the 

transfer or disposal of the material 

Transfer For 3 years after each transfer unless a specific requirement 

dictates otherwise 

Disposal Until the NRC terminates the license 

Important to 

Decommissioning* 

Until the site is released for unrestricted use 

*Information about locations where licensed material is used or stored are among the records important to 

decommissioning and required by 10 CFR 70.25(g). See also the section on “Financial Assurance and 

Recordkeeping for Decommissioning.”

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.

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 Receipt, transfer, and disposal records typically contain the following information: 

2  radionuclide and quantity and date of measurement of special nuclear material 
8-28 

1  for each sealed source, manufacturer, model number, location, and, if needed for 

2 identification, serial number, and as appropriate, manufacturer and model number of 

3 device containing the sealed source 

4  date of the transfer and name and license number of the recipient, and description of the 

5 affected radioactive material (e.g., radionuclide, quantity, manufacturer’s name and 

6 model number, serial number) 

7  for licensed materials disposed of as waste, include the radionuclide, quantity, date of 

8 disposal, and method of disposal (e.g., decay, sewer) 

9 See the Section 8.11, “Waste Management,” for additional information. 

Information about locations where licensed material is used or stored are among the records 

important to decommissioning and required by 10 CFR 70.25(g). Also see Section 8.5.2, 

“Financial Assurance and Recordkeeping for Decommissioning.” 

10 Note: If applicant has enriched uranium in quantities of low and moderate strategic significance 

11 as defined in 10 CFR 70.4, additional material control and accounting (MC&A) requirements 

12 apply per 10 CFR 70.22(b) and 10 CFR Part 74, “Material and Accounting of Special Nuclear 

13 Material.” 

14 Response from Applicant: 

15  Develop a procedure(s) for ensuring material accountability. 

16  If applicable, provide the following statement: “We will comply with the National Source 

17 Tracking System (NSTS) reporting requirement as described in 10 CFR 20.2207.” 

18  Provide a statement that “We will develop, implement, and maintain procedures for 

19 ensuring accountability of licensed materials at all times.”

20 AND 

21  Provide either of the following: 

22 — A statement that: “Physical inventories will be conducted at intervals not to 

23 exceed 6 months, to account for all sealed sources and devices received and 

24 possessed under the license. Records of inventories will be maintained for 5 

25 years from the date of each inventory and will include the radionuclides, 

26 quantities, manufacturer’s name, model numbers, and the date of the inventory.”
8-29 

1 OR 

2 — A description of procedures for ensuring that no sealed sources have been lost, 

3 stolen, or misplaced and how often this will be done. 

4 Notes: 

5  No response is needed from applicants for package opening procedures. Package 

6 opening procedures will be reviewed during NRC inspections. 

7  Alternative responses will be evaluated using the criteria listed above. 

8 References: 

9 See the Notice of Availability on the inside front cover of this report to obtain a copy of 

10  NUREG/BR-0006, Revision 7, “Instructions for Completing Nuclear Material Transaction 

11 Reports (DOE/NRC Forms 741 and 740M) 

12  Many NRC documents can be accessed in the NRC Web site at http://www.nrc.gov. 

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 20.1203, 10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1501, 

16 10 CFR 20.1502, 10 CFR 20.2104, 10 CFR 20.1703, 10 CFR 20.2106, 10 CFR 20 Appendix B

17 Criteria: 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 

23 — 50 mSv [5 rems] shallow-dose equivalent to the skin 

24 — 50 mSv [5 rems] shallow-dose equivalent to any extremity. 

25  minors who are likely to receive an annual dose from sources external to the body in 

26 excess of any of the following (each evaluated separately): 

27 — 1.0 mSv [0.1 rem] deep-dose equivalent 

28 — 1.5 mSv [0.15 rem] lens (of the eye) dose equivalent 

29 — 5 mSv [0.5 rem] shallow-dose equivalent to the skin 

30 — 5 mSv [0.5 rem] shallow-dose equivalent to any extremity. 

31  declared pregnant women who are likely to receive a dose from radiation sources 

32 external to the body during the entire pregnancy in excess of 1.0 mSv [0.1 rem] 

33 deep-dose equivalent 

34  individuals entering a high or very high radiation area 
8-30 

1 Internal exposure monitoring is required, pursuant to 10 CFR 20.1502(b), for the following: 

2  adults likely to receive, in a year, an intake in excess of 10 percent of the applicable 

3 Annual Limit on Intake (ALI) for ingestion and inhalation 

4  minors likely to receive, in a year, a committed effective dose equivalent in excess of 

5 1.0 mSv [0.1 rem] and declared pregnant women likely to receive, during the entire 

6 pregnancy, a committed effective dose equivalent in excess of 1.0 mSv [0.1 rem]. 

Figure 8-7. Annual Dose Limits for Occupationally Exposed Adults 

7 Discussion: 

8 Under 10 CFR 20.1502, “Conditions requiring individual monitoring of external and internal 

9 occupational dose,” if an adult (individual) is likely to receive, in a year, a dose greater than 

10 10 percent of any applicable limit (See Figure 8-7 for annual dose limits), monitoring for 

11 occupational exposure is required. Monitoring is required for minors and declared pregnant 

12 females as shown in the criteria section. The licensee should perform an evaluation of the dose 

13 the individual is likely to receive before allowing the individual to receive the dose. This 

14 evaluation need not be made for every individual; evaluations can be made for employees with 

15 similar job functions or work areas. Further guidance on evaluating the need to provide 

16 monitoring is provided in Appendix G of this NUREG and Regulatory Guide 8.34, “Monitoring 

17 Criteria and Methods to Calculate Occupational Radiation Doses,” dated July 1992. 

18 If this prospective evaluation shows that an adult individual’s dose is not likely to exceed 

19 10 percent of any applicable regulatory limit, there are no recordkeeping or reporting 

20 requirements. For individuals who have received doses at other facilities in the current year, the 

21 previous dose need not be considered in this prospective evaluation. When determining the 

22 need for monitoring, only a dose that could be received at the facilities of the applicant or 

TOTAL EFFECTIVE DOSE EQUIVALENT (TEDE) = SUM OF THE EFFECTIVE DOSE 

EQUIVALENT (FOR EXTERNAL EXPOSURES) + THE COMMITTED EFFECTIVE 

DOSE EQUIVALENT (CEDE) (FOR INTERNAL EXPOSURES) 
8-31 

1 licensee performing the evaluation needs to be considered, including any recordkeeping and 

2 reporting requirements. If it was determined that monitoring was not required and a subsequent 

3 evaluation shows that the 10 percent regulatory threshold has or will be exceeded, the dose 

4 received by an individual when monitoring was not provided should be estimated, recorded, and 

5 reported (if required). These estimates can be based on any combination of work location 

6 radiation monitoring, survey results, monitoring results of individuals in similar work situations, 

7 or other estimates to produce a “best estimate” of the actual dose received. 

8 Licensees should use NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, 

9 “Occupational Dose Record for a Monitoring Period,” to record individual dose. If monitoring is 

10 not required to demonstrate compliance with all limits but is required relative to one or more 

11 specific limits, the licensee should enter “N/A” for “not applicable” in the blocks on NRC Form 4, 

12 “Cumulative Occupational Dose History," and NRC Form 5, “Occupational Dose Record for a 

13 Monitoring Period,” to indicate the areas for which monitoring was not required (e.g., extremity 

14 or skin doses). Where monitoring was provided but not measurable, the licensee should enter 

15 “ND” for “not detectable.” 

16 If the prospective evaluation shows that the individual adult is likely to exceed 10 percent of an 

17 applicable limit, then monitoring and reporting of the results of monitoring performed—

18 regardless of the actual dose received—is required. If air sampling or bioassay is required, 

19 discussion of air sampling or bioassay should provide enough detail so that the NRC staff is 

20 assured that appropriate steps will be taken to manage and monitor such exposure. Licensees 

21 must provide individual radiation exposure data to each worker as required by 10 CFR 19.13. 

22 Licensees should also perform prospective evaluations of the doses that may be received by 

23 occupationally exposed minors and declared pregnant women. As with individual adult workers, 

24 licensees must supply and require the use of individual monitoring devices to monitor external 

25 exposures and monitor the occupational intake of radioactive material when the results of 

26 prospective dose evaluations exceed the doses specified in 10 CFR 20.1502. 

27 When personnel dosimeters that require processing to determine the radiation dose are used to 

28 comply with the individual monitoring requirement for external doses in 10 CFR 20.1502(a), 

29 licensees must use dosimeters supplied by a National Voluntary Laboratory Accreditation 

30 Program (NVLAP)-approved processor. The exchange frequency for dosimeters is typically 

31 monthly or quarterly. Applicants should consult with their NVLAP-approved processor for its 

32 recommendations for exchange frequency and proper use of the dosimeter. 

33 For guidance about methodologies for determination of internal occupational dose and 

34 summation of occupational dose, refer to Regulatory Guide 8.7, “Instructions for Recording and 

35 Reporting Occupational Radiation Exposure Data;” Regulatory Guide 8.34, “Monitoring Criteria 

36 and Methods to Calculate Occupational Radiation Doses;” and Regulatory Guide 8.9, 

37 “Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program.” For 

38 copies of these guidance documents, contact the appropriate NRC regional office or access 

39 NRC’s Web site at http://www.nrc.gov. 

40 Response from Applicant: Provide either of the following: 

41  A statement that: “We will maintain, for inspection by the NRC, documentation 

42 demonstrating that unmonitored individuals are not likely to receive a radiation dose in 

43 excess of the limits in 10 CFR 20.1502.” 
8-32 

1 OR 

2  A statement that: “We will monitor individuals in accordance with the criteria in the 

3 section entitled, ‘Radiation Safety Program - Occupational Dose’ in NUREG–1556, 

4 Volume 17, Rev. 1, “Consolidated Guidance About Materials Licenses: 

5 Program-Specific Guidance About Special Nuclear Material of Less than Critical Mass 

6 Licenses.” 

7 OR, IN LIEU OF THESE STATEMENTS 

8 Provide a description of an alternate method for demonstrating compliance with the referenced 

9 regulations. 

10 Note: 

11  Alternative responses will be evaluated using the criteria listed above. 

12  Some licensees choose to provide personnel dosimetry to their workers for reasons 

13 other than compliance with NRC requirements (e.g., to respond to worker requests). 

14 8.10.5 Public Dose 

15 Regulations: 10 CFR 20.1003, 10 CFR 20.1101, 10 CFR 20.1301, 10 CFR 20.1302, 

16 10 CFR 20.2107

17 Criteria: Licensees must ensure that licensed material will be used, transported, stored, and 

18 disposed of in such a way that members of the public will not receive more than 1 mSv 

19 [100 mrem] in a year, and the dose in any unrestricted area will not exceed 0.02 mSv [2 mrem] 

20 in any one hour, from licensed operations. In addition, licensees must strive to maintain doses 

21 to members of the public that are ALARA. 

22 Discussion: Public dose is defined in 10 CFR Part 20 as “the dose received by a member of 

23 the public from exposure to radiation and/or radioactive material released by a licensee, or to 

24 any other source of radiation under the control of a licensee.” Public dose excludes 

25 occupational doses or doses received from background radiation and medical procedures. 

26 Whether the dose to an individual is an occupational dose or a public dose depends on the 

27 individual’s assigned duties. It does not depend on the area (restricted, controlled, or 

28 unrestricted) the individual is in when the dose is received. 

29 Figure 8-8 shows the steps to calculate the annual dose to an individual member of the public. 
8-33 

Figure 8-8. Calculating Public Dose 

Steps to calculate the annual dose to an individual member of the public 

(see Appendix H for more information about occupancy factors.) 

1 There are many possible dose pathways that contribute to the TEDE. The TEDE can, however, 

2 be broken down into three major dose pathway groups: 

3  airborne radioactive material 

4  waterborne radioactive material 

5  external radioactive exposure 

6 The licensee should review these major pathways and decide which are applicable to 

7 its operations. 

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

9 The extent and frequency of monitoring will depend upon each licensee’s needs. For 

10 additional guidance regarding monitoring of effluents, refer to Section 8.10.8, “Radiation Safety 

11 Program—Surveys.” 

12 Under 10 CFR 20.2107, “Records of dose to individual members of the public,” licensees must 

13 maintain records sufficient to demonstrate compliance with the dose limits for members of the 

14 public until the Commission terminates the license. Refer to Appendix H of this NUREG for 

15 additional guidance regarding compliance with the recordkeeping requirements. 

Calculating the Annual Dose to an 

Individual Member of the Public

1556-012.ppt

041300

Identify all potential sources of external and internal 1 exposure to members of the public

Another facility? Perform the above steps for all 8 facilities

Multiply the maximum annual dose by the 7 occupancy factors to get the annual dose

Multiply the dose rates by the number of hours in a 6 year to produce the maximum annual dose

Calculate predicted occupancy factors at points of 5 maximum dose rates

Identify from survey data, at each location, maximum 4 levels of dose rates

Perform surveys of all locations of use, transport, or 3 storage of radioactive material

Identify all locations of use, transport, or storage 2 of radioactive material

Calculating the Annual Dose to an 

Individual Member of the Public

1556-012.ppt

041300

Identify all potential sources of external and internal 1 exposure to members of the public

Another facility? Perform the above steps for all 8 facilities

Multiply the maximum annual dose by the 7 occupancy factors to get the annual dose

Multiply the dose rates by the number of hours in a 6 year to produce the maximum annual dose

Calculate predicted occupancy factors at points of 5 maximum dose rates

Identify from survey data, at each location, maximum 4 levels of dose rates

Perform surveys of all locations of use, transport, or 3 storage of radioactive material

Identify all locations of use, transport, or storage 2 of radioactive material
8-34 

1 Response from Applicant: No response is required from the applicant in a license application, 

2 but compliance will be examined during inspection. During NRC inspections, licensees must be 

3 able to demonstrate, by measurement or calculation, that the TEDE to the individual likely to 

4 receive the highest dose from the licensed operation does not exceed the annual limit for 

5 members of the public. 

6 8.10.6 Operating and Emergency Procedures 

7 Regulations: 10 CFR 19.11(a)(3), 10 CFR 20.1101, 10 CFR 20.1406, 10 CFR 20.1801, 

8 10 CFR 20.1802, 10 CFR 20.2201-2203, 10 CFR 21.21, 10 CFR Part 37 (Subpart B), 

9 10 CFR 37.21(a), 10 CFR 37.45, 10 CFR 37.49, 10 CFR 70.22(a), 10 CFR 70.23(a)(4), 

10 10 CFR 70.50

11 Criteria: Each licensee should develop, implement, and maintain operating and emergency 

12 procedures that include the following provisions: 

13  instructions to keep radiation doses to workers and members of the public ALARA 

14  instructions for conducting operations to minimize the introduction of residual 

15 radioactivity into the site 

16  instructions for maintaining security during storage and transportation 

17  instructions to maintain accountability during use 

18  instructions for the proper storage and disposal of radioactive waste 

19  use of personnel monitoring and radiation survey equipment 

20  instructions for packaging and transporting licensed material 

21  instructions on how to respond and whom to contact when an emergency occurs 

22  instructions for identifying and reporting to the NRC defects and noncompliance, as 

23 required by 10 CFR 21.21 

24 Licensees that possess an aggregated Category 1 or Category 2 quantity of radioactive 

25 material, listed in Appendix A to 10 CFR Part 37, must also establish, implement, and maintain 

26 its access authorization program; coordinate, to the extent practicable, with local law 

27 enforcement authorities, for responding to threats to the licensee’s facility; and be able to 

28 monitor, detect without delay, assess, and respond to any unauthorized entries into security 

29 zones. 

30 Discussion: Operating and emergency procedures should be developed, maintained, and 

31 implemented to ensure that all licensed material are used in a secure and safe manner in 

32 accordance with licensed activities, control and accountability are maintained, and radiation 

33 doses received by occupational workers and members of the public are ALARA. The operating 

34 procedures should include a description of the operations involving the special nuclear material 

35 and a general plan for carrying out the activity. The written procedures should provide 

36 reasonable assurance that only appropriately trained personnel will handle and use licensed 

37 material without undue hazard to workers or members of the public. Each licensee should 
8-35 

1 develop, implement, and maintain operating and emergency procedures containing the 

2 following elements: 

3  contamination controls 

4  personnel and area monitoring (including frequency and limits) 

5  use of protective clothing and equipment 

6  recording requirements 

7  reporting requirements 

8  actions to be taken in case of an emergency (e.g., spill, fire, ventilation system failure) 

9  waste disposal practices 

10 A copy of the operating and emergency procedures should be posted in all laboratory or work 

11 areas where radioactive materials are used. If posting of procedures is not practicable, the 

12 licensee may post a notice that describes the documents and states where they may be 

13 examined. Also, copies of operating and emergency procedures should be provided to all 

14 authorized users. These instructions should describe immediate action to be taken in case of an 

15 emergency in order to prevent release of radioactive material or further contamination of work 

16 areas and personnel. Examples of emergency procedures are (i) turning off the ventilation 

17 systems, (ii) evacuation of the area, (iii) reentry, (iv) procedures for containment of spills. The 

18 instructions should specifically state the names and telephones numbers of responsible persons 

19 to be notified. 

20 All licensed materials stored in controlled or unrestricted areas must be secured from 

21 unauthorized access or removal so that individuals who may not be knowledgeable about 

22 radioactive materials cannot be exposed to or contaminated by the material, and so that 

23 individuals cannot take the material. When any licensed materials are in use in controlled or 

24 unrestricted areas, they must be under constant surveillance so that the radiation worker can 

25 prevent others from becoming contaminated by or exposed to the material and prevent 

26 unauthorized persons from removing the material from the area. 

27 Licensees should develop procedures that clearly state acceptable methods to secure licensed 

28 material at a facility. Particular attention may be required at facilities that have unusual needs 

29 because of the activities performed, such as hot cells and waste processing facilities. Security 

30 procedures may be in a separate document or included in the “General Safety Procedures.” 

The NRC must be notified when licensed material is lost, stolen, or other related conditions 

occur. The RSO must be proactive in evaluating if NRC notification is required. Refer to 

Appendix L and the regulations (10 CFR 20.2201-20.2203, 10 CFR 70.50, and 10 CFR 21.21) 

for a description of when and where notifications are required. 
8-36 

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. 

 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. 

1 Response from Applicant: The applicant must state that procedures for safe use of materials 

2 and emergencies have been developed or will be developed before receipt of licensed material. 

3 If you want the option to make changes in the procedures, include a statement that “Procedures 

4 may be revised only if (i) the changes are reviewed and approved by the licensee management 

5 and the RSO in writing; (ii) the licensee staff is provided training in the revised procedures prior 

6 to implementation; (iii) the changes are in compliance with the NRC regulations and the license; 

7 and (iv) the changes do not degrade the effectiveness of the program.”

8 8.10.7 Leak Tests 

9 Regulations: 10 CFR 20.1501, 10 CFR 20.2103, 10 CFR 70.39, 10 CFR 70.56 

10 Criteria: The NRC requires testing to determine whether there is any radioactive leakage from 

11 the sealed sources. Records of test results must be maintained. 

12 Discussion: When issued, a license will require performance of leak tests at intervals 

13 approved by the NRC or an Agreement State and specified in the SSD registration certificate. 

14 The measurement of the leak-test sample is a quantitative analysis requiring that 

15 instrumentation used to analyze the sample be capable of detecting 185 Bq [0.005 microcurie] 

16 of radioactivity. 

17 Manufacturers, consultants, and other organizations may be authorized by the NRC or an 

18 Agreement State to either perform the entire leak test sequence for other licensees or provide 

19 leak test kits to licensees. In the latter case, the licensee is expected to take the leak test 

20 sample according to the kit supplier’s instructions and return it to the kit supplier for evaluation 

21 and reporting results. Leak test samples should be collected at the most accessible area where 

22 contamination would accumulate if the sealed source were leaking. Licensees may also be 

23 authorized to conduct the entire leak test sequence themselves. 
8-37 

1 For more information regarding leak tests, see Appendix J of this NUREG. 

2 Response from Applicant: Do one of the following: 

3  State: “Leak tests will be performed at intervals approved by the NRC or an Agreement 

4 State and specified in the Sealed Source and Device Registration Certificate. Leak tests 

5 will be performed by an organization authorized by NRC or an Agreement State to 

6 provide leak testing services to other licensees or using a leak test kit supplied by an 

7 organization authorized by NRC or an Agreement State to provide leak test kits to other 

8 licensees and according to the kit supplier’s instructions.” 

9 OR 

10  State: “Leak tests will be performed at intervals approved by NRC or an Agreement 

11 State and specified in the Sealed Source and Device Registration Certificate. Leak tests 

12 will be performed by an organization authorized by NRC or an Agreement State to 

13 provide leak testing services to other licensees or using a leak test kit supplied by an 

14 organization authorized by NRC or an Agreement State to provide leak test kits to other 

15 licensees and according to the kit supplier’s instructions. As an alternative, we will 

16 implement the model leak test program published in Appendix J to the current version of 

17 NUREG–1556, Volume 17, “Program-Specific Guidance About Special Nuclear Material 

18 of Less Than Critical Mass Licenses.” 

19 OR 

20  Provide a description of alternative equipment or procedures for determining whether 

21 there is radioactive leakage from sealed sources. 

22 Note:

23  Alternative responses will be reviewed using the criteria listed above. 

24  If a sealed source is added to an existing license, that license might already authorize 

25 the licensee to perform the entire leak test sequence. In this case, the licensee may 

26 perform the leak testing on the sealed source according to the procedures previously 

27 approved on its license. 

28 8.10.8 Surveys 

29 Regulations: 10 CFR 20.1501, 10 CFR 20.1906, 10 CFR 20.2103

30 Criteria: 10 CFR 20.1501 and 10 CFR 20.2103 contain general survey and survey 

31 recordkeeping requirements. 10 CFR 20.1906 contains general survey requirements for 

32 receiving and opening packages. 

33 Discussion: Survey is defined as an evaluation of the radiological conditions and potential 

34 hazards incident to the production, use, transfer, release, disposal, or presence of radioactive 

35 material or other sources of radiation (See Figure 8-9). These evaluations may be 

36 measurements (e.g., radiation levels measured with survey instrument or results of wipe tests 

37 for contamination), calculation, or a combination of measurements and calculations. The 

38 selection and proper use of appropriate instruments is one of the most important factors in 
8-38 

1 ensuring that surveys accurately assess the radiological conditions. To meet regulatory 

2 requirements for surveying, measurements of radiological quantities should be understood in 

3 terms of their properties (i.e., alpha, beta, gamma, and neutrons) and compared to the 

4 appropriate limits. Licensees should also use surveys to plan work in areas where licensed 

5 material or radiation exists and to evaluate doses to workers and individual members of the 

6 public. In certain cases, environmental monitoring may be required to demonstrate compliance 

7 with 10 CFR Part 20. 

Figure 8-9. Types of Surveys 

There are many different types of surveys performed by SNM licensees. 

8 Radiation surveys are used to detect and evaluate contamination of: 

9  facilities 

10  equipment 

11  personnel (during use, transfer, or disposal of licensed material) (See Figure 8-10) 

12  restricted and unrestricted areas 

13  packages 

14 Surveys are also used to plan work in areas where licensed material or radiation exists and to 

15 evaluate doses to workers and individual members of the public. 

1556-032.ppt

041300

RSO

Types of

Surveys Types of 

Surveys

• Contamination

– Fixed

– Removable

• Air Effluent

• Water Effluent

• Leak Test

• Bioassays

• Air Sample

• General Area

– Restricted

– Unrestricted

1556-032.ppt

041300

RSO

Types of

Surveys

Types of

Surveys Types of 

Surveys

• Contamination

– Fixed

– Removable

• Air Effluent

• Water Effluent

• Leak Test

• Bioassays

• Air Sample

• General Area

– Restricted

– Unrestricted

Types of 

Surveys

• Contamination

– Fixed

– Removable

• Air Effluent

• Water Effluent

• Leak Test

• Bioassays

• Air Sample

• General Area

– Restricted

– Unrestricted

Types of 

Surveys

• Contamination

– Fixed

– Removable

• Air Effluent

• Water Effluent

• Leak Test

• Bioassays

• Air Sample

• General Area

– Restricted

– Unrestricted

Types of 

Surveys

• Contamination

– Fixed

– Removable

• Air Effluent

• Water Effluent

• Leak Test

• Bioassays

• Air Sample

• General Area

– Restricted

– Unrestricted
8-39 

Figure 8-10. Personnel Surveys 

 Users of unsealed licensed material should check themselves for contamination 

(frisk) before leaving the laboratory. 

1 Under 10 CFR 20.1501(a), surveys are required when it is reasonable under the circumstances 

2 to evaluate a radiological hazard. Many different types of surveys may need to be performed 

3 due to the particular use of licensed materials. Typical surveys may include: 

4  Surveys for radioactive contamination that could be present on surfaces of floors, walls, 

5 laboratory furniture, equipment, and packages of radioactive material received or 

6 prepared for shipment. 

7  Measurements of radioactive material concentrations in air for areas where radioactive 

8 materials are handled or processed in unsealed form and where operations could 

9 expose workers to the inhalation of radioactive material or where licensed material is or 

10 could be released to unrestricted areas. 

11  Measurements of radioactive material concentrations in water that is released to the 

12 environment or to the sanitary sewer. 

13  bioassays to determine the kinds, quantities or concentration, and in some cases, the 

14 location of radioactive material in the human body. (A bioassay can be made by direct 

15 measurement, in vivo counting, or by analysis and evaluation of material excreted or 

16 removed from the human body.) 

17  Measurements of external radiation exposure levels in both restricted and 

18 unrestricted areas. 

19 The frequency of routine surveys depends on the nature, quantity, and use of radioactive 

20 materials, as well as the specific protective facilities, equipment, and procedures that are 

21 designed to protect the worker from external and internal exposure. Also, the frequency of the 

22 survey depends on the type of survey, such as those listed above (see Appendix I of this 

23 NUREG). 

24 Not all instruments can measure a given type of radiation. The presence of other radiation may 

25 interfere with a detector’s ability to measure the radiation of interest. Correct use of radiation 

26 detection and measurements is an important aspect of any radiation safety program. 

Surveying arm and hand using survey 

meter and gamma probe.

1556-016.ppt

041300

Surveying feet and legs using survey 

meter and gamma probe

Surveying arm and hand using survey 

meter and gamma probe.

1556-016.ppt

041300

Surveying feet and legs using survey 

meter and gamma probe
8-40 

1 10 CFR Part 20 does not specify limits for surface contamination. Each applicant should 

2 propose and justify what removable surface contamination limits will be allowable before 

3 decontamination will be performed in each work area. Table I–2 in Appendix I of this 

4 NUREG contains contamination limits that are acceptable to the NRC. Note that Subpart E of 

5 10 CFR Part 20 contains the radiological criteria for license termination and that these criteria 

6 are acceptable to the decommissioning of facilities that are to be released for unrestricted use, 

7 even if the license continues in effect at other locations. Guidance for survey criteria to meet 

8 the license termination criteria may be found in NUREG–1757, “Consolidated Decommissioning 

9 Guidance.” 

10 Also, NUREG–1575, “Multi-Agency Radiation Survey and Site Investigation Manual 

11 (MARSSIM),” dated August 2000, contains additional guidance concerning surveys during the 

12 decommissioning of facilities. Licensees that have facilities to decommission should review 

13 this document. 

14 Response from Applicant: Choose one of the following: 

15  State: “We will survey our facility and maintain contamination levels in accordance with 

16 the survey frequencies and contamination levels published in Appendix I to the current 

17 version of NUREG–1556, Volume 17, ‘Program-Specific Guidance About Special 

18 Nuclear Material of Less Than Critical Mass Licenses.’” 

19 OR 

20  Submit description of alternative equipment or procedures to evaluate a radiological 

21 hazard. 

22 Note:

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

24 8.10.9 Transportation 

25 Regulations: 10 CFR 20.1101, 10 CFR Part 37 (Subpart D), 10 CFR 70.42, 10 CFR 70.51, 

26 10 CFR 71.5, 10 CFR 71.14, 10 CFR 71.22, 10 CFR 71.37, 10 CFR 71.38, 10 CFR 71.47, 

27 10 CFR 71.63, 10 CFR 71.64, 10 CFR 71.81, 10 CFR 71.83, 10 CFR 71.85, 10 CFR 71.87, 

28 10 CFR 71.88, 10 CFR 71.89, 10 CFR 71.91, 10 CFR 71.95, 10 CFR 71.97, 10 CFR Part 71 

29 (Subpart H), 49 CFR Parts 171-180, 49 CFR Parts 390-397

30 Criteria: Licensees and applicants who will transport or ship licensed material, including 

31 radioactive waste, must develop, implement, and maintain safety programs for transport of 

32 radioactive material to ensure compliance with NRC and DOT regulations. In accordance with 

33 10 CFR Part 37 (Subpart D), licensees must also preplan, coordinate and provide advance 

34 notification of the shipment of Category 1 quantities of radioactive material and coordinate the 

35 shipment of Category 2 quantities of radioactive material. 

36 Discussion: Licensed material, including radioactive waste, must be packaged and transported 

37 in accordance with NRC and DOT requirements if the transportation involves the use of public 

38 highways. Appendix K of this NUREG contains a list of major DOT regulations applicable to 

39 transportation of special nuclear material (SNM) of less than critical mass. Licensees and 

40 applicants also should consider the safety of all individuals who may handle or may come in 
8-41 

1 contact with the packages containing licensed material. Therefore, the primary considerations 

2 in packaging licensed material should be to ensure that the package integrity is not 

3 compromised during transport and that the radiation levels (including removable contamination 

4 levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, 

5 “External radiation standards for all packages,” but also are ALARA. 

6 The general licenses in 10 CFR 71.17, “General license: NRC-approved package,” and, 

7 10 CFR 71.22, “General license: Fissile material,” provide the authorization used by most 

8 Special Nuclear Material of Less than Critical Mass licensees to transport, or offer for transport, 

9 packages of radioactive material and specify certain conditions. Most packages offered by such 

10 NRC licensees contain quantities of radioactive material that require using a Type A package. 

11 However, before offering any fissile material packages for shipment under the provisions of a 

12 general license, the licensee is required to implement an NRC-approved quality assurance (QA) 

13 plan. For information about QA plans, see Revision 2 of Regulatory Guide 7.10, “Establishing 

14 Quality Assurance Programs for Packaging Used in Transport of Radioactive Material,” dated 

15 March 2005. For further information about submitting a QA program for review, contact the 

16 NRC’s Division of Spent Fuel Storage and Transportation by calling the NRC’s toll-free number 

17 800-368-5642. 

18 Each licensee must also assure that plutonium in any form, whether for import, export, or 

19 domestic shipment, is not transported by air or delivered to a carrier for air transport unless the 

20 provisions of 10 CFR 71.88, “Air transport of plutonium;” 10 CFR 71.63, “Special requirements 

21 for plutonium shipments;” and 10 CFR 71.64, “Special requirements for plutonium air 

22 shipments,” are fully satisfied. 

23 For additional guidance regarding the transportation of radioactive material, refer to 

24 NUREG–1660, “U.S. Specific Schedules of Requirements for Transport of Specified Types of 

25 Radioactive Material Consignments.” 

26 Licensees shipping radioactive waste for disposal must prepare appropriate documentation as 

27 specified in 10 CFR Part 20 Appendix G, “Requirements for Transfers of Low-Level Radioactive 

28 Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests.” 

29 During its inspections, the NRC uses the provisions of 10 CFR 71.5, “Transportation of licensed 

30 material,” and a Memorandum of Understanding with DOT on the Transportation of Radioactive 

31 Materials (44 Fed. Reg. 38690, July 2 1979) to examine whether licensees are in compliance 

32 with the applicable DOT requirements referenced in 10 CFR 71.5. 

Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive material 

are subject to the requirements in 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. 
8-42 

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

2 Compliance with transportation requirements will be reviewed during NRC inspections. 

3 References: 

4  “Radioactive Material Regulations Review” is available from DOT at 

5 www.phmsa.dot.gov. 

6  1979 Memorandum of Understanding with DOT on the Transportation of 

7 Radioactive Material. 

8  Regulatory Guide 7.10, “Establishing Quality Assurance Programs for Packaging Used 

9 in the Transport of Radioactive Material.” 

10  NUREG–1660, “U.S. Specific Schedules of Requirements for Transport of Specified 

11 Types of Radioactive Material Consignments.” 

12 8.10.10 Minimization of Contamination 

13 Regulation: 10 CFR 20.1406

14 Criteria: Applicants must describe how facility design and procedures for operation will 

15 minimize, to the extent practicable, contamination of the facility and the environment, facilitate 

16 eventual decommissioning, and minimize, to the extent practicable, the generation of 

17 radioactive waste. 

18 Discussion: When designing facilities and developing procedures for their safe use, applicants 

19 should think ahead and consider how to minimize radioactive contamination during operation, 

20 decontamination and decommissioning efforts, and radioactive waste generation. When 

21 submitting new applications, applicants should consider the following: 

22  implementation of and adherence to good health physics practices in operations 

23  minimization of areas, to the extent practicable, where licensed materials are used 

24 and stored 

25  maximization of the frequency of surveys, within reason, to minimize spread of 

26 contamination in the event of a spill 

27  choice of isotope to be used, whenever practical, in consideration of half-life and 

28 chemical composition 

29  appropriate filtration of effluent streams’ use of nonporous materials for laboratory bench 

30 tops, flooring, etc. 

31  ventilation stacks and ductwork with minimal lengths and minimal abrupt changes 

32 in direction 
8-43 

1  use of appropriate plumbing materials with minimal pipe lengths and traps 

2  minimization of the number of disposal sites (sinks) where liquid waste is disposed 

3 SNM sealed sources and devices that are approved by the NRC or an Agreement State and 

4 located and used according to their SSD Registration Certificates usually pose little risk of 

5 contamination. Leak tests performed as specified in the SSD Registration Certificate should 

6 identify defective sources. Leaking sources must be withdrawn immediately from use and 

7 decontaminated, repaired, or disposed of in accordance with the disposal requirements in 

8 Subpart K of 10 CFR Part 20. These steps minimize the spread of contamination and reduce 

9 radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive 

10 waste do not apply to programs using only sealed sources and devices that have not leaked. 

11 Note: An unregistered custom or encapsulated source should be treated as unsealed 

12 material, and licensees should maintain appropriate facilities and safety equipment to 

13 minimize contamination. 

14 Response from Applicant: The applicant does not need to provide a response to this item 

15 under the following condition. The NRC will consider that the above criteria have been met if 

16 the applicant’s responses meet the criteria in the following sections of this NUREG: 

17 Section 8.5.1, “Radioactive Material—Sealed Sources and Devices or Unsealed Radioactive 

18 Material;” Section 8.9, “Facilities and Equipment;” Section 8.10.6, “Radiation Safety Program—

19 Operating and Emergency Procedures;” Section 8.10.7, “Radiation Safety Program—Leak 

20 Tests;” Section 8.10.8, “Radiation Safety Program—Surveys;” and Section 8.11, 

21 “Waste Management.” 

22 8.10.11 Security Program for Special Nuclear Material of Less Than Critical 

23 Mass 

24 The regulations requiring control, security, and physical protection of special nuclear material 

25 (SNM) are graded based on the risk of the SNM to be used for malicious purposes. Basic 

26 control of licensed material is covered in 10 CFR Part 20, Subpart I. Subpart I requires 

27 licensees to secure licensed materials in storage from unauthorized removal or access, and to 

28 control and maintain constant surveillance of licensed material that is in a controlled or 

29 unrestricted area and that is not in storage. 

30 The existing SNM physical protection regulatory requirements applicable at fixed sites and to 

31 material in transit are located in 10 CFR Part 73 as discussed below, and are graded using a 

32 material categorization approach. The existing material categorization approach places 

33 uranium and plutonium into one of three risk categories (“formula quantity” of strategic SNM, 

34 SNM of “moderate strategic significance,” and SNM of “low strategic significance,” as defined in 

35 10 CFR 73.2), depending on the type, quantity (i.e., mass) and enrichment of the SNM. The 10 

36 CFR Part 37 requirements described in Section 8.10.11.2 are applicable to licensees 

37 possessing Plutonium-238 or Plutonium 239/Be with an aggregated quantity of total activity 

38 greater thanor equal to the amounts listed in Appendix A to 10 CFR Part 37. 

39 Applicants and licensees should review its types and forms of SNM to determine which security 

40 or physical protection requirements apply. 
8-44 

1 8.10.11.1 Physical Protection System for Special Nuclear Material of Low 

2 Strategic Significance 

3 Regulations: 10 CFR 70.22, 10 CFR 73.67 

4 Criteria: Licensees must ensure the security of special nuclear material of low 

5 strategic significance. 

6 Note: The regulations in 10 CFR Part 73 provide SNM physical protection requirements based 

7 on its category. The categories are based primarily on the ability of an adversary to create an 

8 improvised nuclear device (IND) using SNM. However, the regulations contain exemptions and 

9 exceptions, where material is not required to be protected within the three-category approach. 

10 With respect to 10 CFR Part 73, this guidance only addresses the physical protection 

11 requirements for SNM of low strategic significance. 

12 Discussion: A quantity of SNM of low strategic significance relevant to this guidance means 

13 more than 15 grams of uranium-235 (contained in uranium enriched to 20 percent) or 15 grams 

14 of uranium-233 or 15 grams of plutonium or the combination of 15 grams when computed by the 

15 equation, grams = (grams contained U–235) + (grams plutonium) + (grams U–233). 

16 10 CFR 73.67(b)(1) states that a licensee is exempt from the requirements in 10 CFR 73.67 for 

17 certain types and forms of SNM. 

18 In accordance with 10 CFR 73.67, licensees authorized to possess SNM of low strategic 

19 significance must establish, implement, and maintain a physical protection system that will 

20 minimize the possibilities for unauthorized removal of SNM and facilitate the location and 

21 recovery of missing SNM. To achieve these objectives, the physical protection system shall 

22 provide: (1) early detection and assessment of unauthorized access or activities by an external 

23 adversary within the controlled access area containing SNM, (2) early detection of removal of 

24 SNM by an external adversary from a controlled access area, (3) assure proper placement and 

25 transfer of custody of SNM, and (4) respond to indications of an unauthorized removal of SNM 

26 and then notify the appropriate response forces of its removal to facilitate its recovery. 

27 NRC Regulatory Guide 5.59, “Standard Format and Content for a Licensee Physical Security 

28 Plan for the Protection of Special Nuclear Material of Moderate or Low Strategic Significance,” 

29 contains additional guidance on developing a low strategic significance SNM physical 

30 protection system. 

31 Physical Protection Requirements at Fixed Sites 

32 In accordance with 10 CFR 73.67(f), licensees shall only possess, store or use low strategic 

33 significance SNM at a fixed site or contiguous sites within a controlled access area. A 

34 controlled access area is any temporarily or permanently established area that is clearly 

35 demarcated, typically with a barrier (e.g., fence or wall), access to which is controlled, and which 

36 affords isolation of the material or persons within the controlled access area. The controlled 

37 access area shall be monitored with an intrusion alarm or other device or procedures to detect 

38 unauthorized penetrations or activities. Licensees shall assure that a watchman or offsite 

39 response force will respond to all unauthorized penetrations or activities in the controlled access 

40 areas, and shall also establish and maintain written response procedures for dealing with 

41 threats of thefts or thefts of SNM of low strategic significance. 
8-45 

1 Physical Protection Requirements in Transit 

2 In accordance with 73.67(g)(1), licensees that transport or deliver to a carrier for transport SNM 

3 of low strategic significance shall provide advance notification to the receiver of any planned 

4 shipments specifying the mode of transport, estimated time of arrival, location of the nuclear 

5 material transfer point, name of carrier, and transport identification. Prior to commencing the 

6 shipment, licensees shall receive from the receiver (i) confirmation that the receiver will be 

7 ready to accept the shipment at the planned time and location and (ii) an acknowledgment of 

8 the specified mode of transport. Transport of SNM of low strategic significance shall be in a 

9 tamper indicated sealed container. Prior to shipment, licensees shall check the integrity of the 

10 container and locks or seals. Licensees that transport or deliver to a carrier for transport SNM 

11 of low strategic significance shall arrange for the in-transit physical protection of the material 

12 unless the receiver is a licensee and has agreed in writing to make such arrangements. 

13 Per 10 CFR 73.67(g)(2), licensees receiving quantities and types of SNM of low strategic 

14 significance shall (i) check the integrity of the containers and seals upon receipt of the shipment, 

15 (ii) notify the shipper of receipt of the material, and (iii) arrange for the in-transit physical 

16 protection of the material unless the shipper is a licensee and has agreed in writing to arrange 

17 for the in-transit physical protection. 

18 In accordance with 10 CFR 73.67(g)(3), each licensee, either shipper or receiver, who arranges 

19 for the physical protection of SNM of low strategic significance shall establish and maintain 

20 response procedures for dealing with threats of thefts or thefts of this SNM. Licensees shall 

21 also make arrangements to be notified immediately of the arrival of the shipment at its 

22 destination, or of any such shipment that is lost or unaccounted for after the estimated time of 

23 arrival at its destination. Additionally, licensees shall conduct immediately a trace investigation 

24 of any shipment that is lost or unaccounted for after the estimated arrival time and notify the 

25 NRC Operations Center within one hour after the discovery of the loss of the shipment and 

26 within one hour after recovery of or accounting for such lost shipment. 

27 The licensee shall retain procedures and records as required by 10 CFR 73.67. 

28 Response from Applicant: 

29 No response is required from an applicant or licensee. 

30 8.10.11.2 Security Program for Category 1 and Category 2 Radioactive Material 

31 Regulations: 10 CFR Part 37 

32 Criteria: Licensees must ensure the security of Category 1 and Category 2 

33 radioactive material. 

34 Note: The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated 

35 Category 1 or Category 2 quantity of radioactive material. The specific radionuclides subject to 

36 10 CFR Part 37 requirements are listed in Table 1 of Appendix A to 10 CFR Part 37. 

37 Discussion: 

38 The NRC issued 10 CFR Part 37 to establish security requirements for the use and transport of 

39 Category 1 and Category 2 quantities of radioactive material that are widely used in the U.S. by 
8-46 

1 industrial, medical, and academic institutions. The theft or diversion of risk-significant quantities 

2 of radioactive materials could lead to their use in a radiological dispersal device (RDD) or a 

3 radiological exposure device (RED). The security of plutonium-238 material and 

4 plutonium/beryllium encapsulated or sealed sources is addressed by Part 37. However, other 

5 plutonium isotopes or unsealed material are not addressed by Part 37. 

6 Requirements in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities 

7 of Radioactive Material” 

8 In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or 

9 Category 2 quantities of radioactive material must establish, implement, and maintain an access 

10 authorization program (Subpart B) and a security program (Subpart C) to ensure physical 

11 protection of the radioactive material. 

12 Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37, 

13 lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

14 should refer to this table to determine whether its proposed activities would be subject to the 

15 10 CFR Part 37 requirements. 

16 Before giving individuals unescorted access to Category 1 or Category 2 quantities of 

17 radioactive material (as defined in 10 CFR 37.5), licensees must conduct background 

18 investigations of these individuals, to determine that they are trustworthy and reliable, in 

19 accordance with 10 CFR 37.25. 

20 In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to 

21 monitor and, without delay, detect, assess, and respond to any actual or attempted 

22 unauthorized access to Category 1 or Category 2 quantities of radioactive material. 

23 Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

24 Category 2 quantities of radioactive materials in transit. These requirements apply to licensees 

25 delivering such material to a carrier for transport, as well as cases in which licensees are 

26 transporting such material. Please note that the Subpart D requirements applicable to the 

27 transport of Category 1 quantities of radioactive material are more stringent than those 

28 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. 

29 For additional guidance on implementing 10 CFR Part 37 requirements, see 

30 NUREG-2155, “Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 

31 1 and Category 2 Quantities of Radioactive Material.”” Additional information regarding best 

32 practices for protection of risk-significant radioactive material is available in NUREG-2166, 

33 “Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 
8-47 

1 Response from Applicant: 

2 No response is required from an applicant or licensee. Compliance with access authorization 

3 and security program requirements may be reviewed during NRC inspections. 

4 8.11 Item 11: Waste Management 

5 Regulations: 10 CFR 20.1501, 10 CFR 20.1904, 10 CFR 20.2001, 10 CFR 20.2002, 

6 10 CFR 20.2003, 10 CFR 20.2004, 10 CFR 20.2005, 10 CFR 20.2006, 10 CFR 20.2007, 

7 10 CFR 20.2108, 10 CFR 37.11(c), 10 CFR 70.51, 10 CR 71.43

8 Criteria: Radioactive waste must be disposed of in accordance with regulatory requirements 

9 and license conditions. Appropriate records of waste disposal must be maintained. 

10 Discussion: Radioactive waste is normally generated when conducting licensed activities. 

11 Such waste may include used or unused radioactive material or unusable items contaminated 

12 with radioactive material (e.g., absorbent paper, gloves). Licensees may not receive radioactive 

13 waste from other licensees for processing, storage, or disposal, unless specifically authorized to 

14 do so by the NRC. 

15 All radioactive waste should be stored in appropriately labeled containers until it is disposed. 

16 During the period between storage and disposal, waste container integrity must be assured. All 

17 radioactive waste must be secured against unauthorized access or removal by unauthorized 

18 personnel. The NRC requires licensees to manage radioactive waste generated at their 

19 facilities by one or more of the following methods: 

20  transfer to an authorized recipient 

21  release into sanitary sewerage 

22  extended interim storage 

23  obtaining prior approval of the NRC of any alternate method 

24  release in effluents to unrestricted areas, other than into sanitary sewerage 

25  incineration 

26 Licensees may choose any one or more of these methods to dispose of their radioactive waste. 

27 It has been the NRC’s experience that many of the facilities dispose of SNM by the first method. 

28 Applicants wanting to dispose of radioactive waste by incineration should contact the 

29 appropriate Regional Office of the NRC for guidance and refer to Policy and Guidance Directive 

30 PG 8-10, “Disposal of Incineration Ash as Ordinary Waste,” dated January 1997. 

Note: Compliance with NRC regulations does not relieve a licensee of the responsibility of 

complying with any other applicable Federal, State, or local regulations. Furthermore, some 

radioactive waste called “mixed waste” may include additional hazards (e.g., biohazard or 

chemical hazard). The storage and disposal of “mixed waste” must also comply with all other 

applicable Federal, State, and local regulatory requirements. 

31 Applicants should describe their program for management and disposal of radioactive waste. 

32 The program should include procedures for handling of waste, safe and secure storage, waste 

33 characterization, waste minimization, and disposal of radioactive waste. Appropriate training 

34 should be provided to waste handlers. In accordance with 10 CFR 20.2108, licensees must 
8-48 

1 maintain all appropriate records of radioactive waste disposal. The U.S. Environmental 

2 Protection Agency (EPA) issued guidance for developing a comprehensive program to reduce 

3 hazardous waste that, in many instances, may also include radioactive waste. The NRC 

4 transmitted these guidelines to licensees in IN-94-23, “Guidance to Hazardous, Radioactive and 

5 Mixed Waste Generators on the Elements of a Waste Minimization Program,” dated 

6 March 1994. 

7 Release Into Sanitary Sewerage 

8 Regulations in 10 CFR 20.2003, “Disposal by release into sanitary sewerage,” authorize 

9 disposal of radioactive waste by release into a public sanitary sewerage system if each of the 

10 following conditions is met: 

11  Material is readily soluble (or is easily dispersible biological material) in water. 

12  Quantity of licensed material that the licensee releases into the sewer each month 

13 averaged over the monthly volume of water released into the sewer does not exceed the 

14 concentration specified in 10 CFR Part 20, Appendix B, Table 3. 

15  If more than one radioisotope is released, the sum of the ratios of the average monthly 

16 discharge of a radioisotope to the corresponding limit in 10 CFR Part 20, Appendix B, 

17 Table 3, cannot exceed unity. 

18  Total quantity of licensed material released into the sanitary sewerage system in a year 

19 does not exceed 185 GBq [5 Ci] of H-3, 37 GBq [1 Ci] of C-14, and 37 GBq [1 Ci] of all 

20 other radioisotopes (including SNM) combined. 

21 Licensees are responsible for demonstrating that licensed materials discharged into the public 

22 sewerage system are indeed readily soluble in water. The NRC’s IN 94-07, “Solubility Criteria 

23 for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR 20,” dated 

24 January 1994, provides acceptable criteria for evaluating solubility of liquid waste. Liquid 

25 scintillation media and ash are examples of material that may or may not be “readily 

26 dispersible.” Careful consideration should be given to the possibility of reconcentration of 

27 radioisotopes that are released into the sewer. The NRC alerted licensees to the potentially 

28 significant problem of reconcentration of radionuclides released to sanitary sewage systems in 

29 IN 84-94, “Reconcentration of Radionuclides Involving Discharges into Sanitary Sewage 

30 Systems Permitted Under 10 CFR 20.303 (now 10 CFR 20.2003, “Disposal by release into 

31 sanitary sewerage”), dated December 1984. 

32 The regulations in 10 CFR 20.2003 are not applicable for releases to a private sewerage 

33 treatment system, a septic system, or leach fields. Licensees may make releases to these 

34 systems as effluents released to unrestricted areas under 10 CFR 20.1301, “Dose limits for 

35 individual members of the public.” However, if licensed material is released to a private 

36 sewerage treatment system, septic system, or leach field, the sludge or other solids from these 

37 systems may become contaminated with radioactive material. Such sludge may be required to 

38 be disposed of as radioactive waste, using one of the methods described in this section. 

39 Applicants should provide procedures that will ensure that all releases of radioactive waste into 

40 the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the 

41 monthly and annual limits specified in regulations. Licensees are required to maintain accurate 
8-49 

1 records of all releases of licensed material into the sanitary sewerage. A model program for 

2 disposal of radioactive waste via sanitary sewer is described in Appendix N of this NUREG. 

3 Transfer to an Authorized Recipient 

4 Licensees may transfer radioactive waste to an authorized recipient for disposal. It is the 

5 licensee’s responsibility to verify that the intended recipient is authorized to receive the 

6 radioactive waste prior to making any shipment. The radioactive waste must be packaged in 

7 approved containers for shipment, and each container must identify the radioisotopes and the 

8 amounts contained in the waste. Additionally, packages must comply with the requirements of 

9 the license for a particular burial site and State requirements. Each shipment must comply 

10 with all applicable NRC and DOT requirements. In some cases, the waste handling contractor 

11 may provide guidance to the licensee for packaging and transportation requirements; however, 

12 the licensee is ultimately responsible for ensuring compliance with all applicable 

13 regulatory requirements. 

14 The shipper must provide all information required in the NRC’s “Uniform Low-Level Radioactive 

15 Waste Manifest,” and transfer this recorded manifest information to the intended recipient in 

16 accordance with 10 CFR Part 20, Appendix G, “Requirements for Transfers of Low-Level 

17 Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests.” 

18 Each shipment manifest must include a certification by the waste generator, as specified in 

19 Section II of the appendix. Each person involved in the transfer for disposal and disposal of 

20 waste, including waste generator, waste collector, waste processor, and disposal facility 

21 operator, must comply with requirements specified in Section III, “Control and Tracking,” of 

22 Appendix G. 

23 Licensees should implement procedures to reduce the volume of radioactive waste for final 

24 disposal in an authorized low-level radioactive waste (LLW) disposal facility. These procedures 

25 include volume reduction by segregating, consolidating, compacting, or allowing certain waste 

26 to decay in storage. Waste compaction or other treatments can reduce the volume of 

27 radioactive waste, but such processes may pose additional radiological hazards (e.g., airborne 

28 radioactivity) to workers and members of the public. The program should include adequate 

29 safety procedures to protect workers, members of the public, and the environment. 

Applicants should preplan the disposal because of the difficulties and costs associated with 

disposal of sealed sources. Applicants may want to consider contractual arrangements with 

the source supplier as part of a purchase agreement. 

30 Alternate Methods 

31 Applicants may also request alternate methods for the disposal of radioactive waste generated 

32 at their facilities. Such requests must describe the waste containing licensed material, including 

33 the physical and chemical properties that may be important to assess risks associated with the 

34 waste, and the proposed manner and conditions of waste disposal, in accordance with 

35 10 CFR 20.2002. Additionally, the applicant must submit its analysis and evaluation of pertinent 

36 information on the nature of the environment, nature and location of other affected facilities, and 

37 operating and emergency procedures to ensure that radiation doses are maintained ALARA and 

38 within regulatory limits. 
8-50 

1 Some licensees do not have an LLW disposal facility available to them and, therefore, must use 

2 on-site interim storage until such time that a facility becomes available. Licensees should 

3 exhaust all possible alternatives for disposal of radioactive waste and rely upon on-site 

4 extended interim storage of radioactive waste only as a last resort. The protection of workers 

5 and the public is enhanced by disposal rather than storage of waste. Licensees may also find it 

6 more economical to dispose of radioactive waste than to store it on-site because as the 

7 available capacity decreases, the cost of disposal of radioactive waste may continue to 

8 increase. LLW should be stored only when disposal capacity is unavailable and for no longer 

9 than is necessary. NRC IN 90-09, “Extended Interim Storage of Low-Level Radioactive Waste 

10 by Fuel Cycle and Materials Licensees,” dated February 1990, provides guidance to licensees 

11 for requesting an amendment to authorize extended interim storage of LLW. 

12 Note: Before licensed activities are transferred or assigned in accordance with 10 CFR 70.36, if 

13 licensees are authorized to possess special nuclear material, the licensees must, in accordance 

14 with 10 CFR 70.51(b)(1)&(2), transfer the following records to the new licensee, as follows: 

15  records of disposal of licensed material made under 

16 — 10 CFR 20.2002, “Method for obtaining approval of proposed 

17 disposal procedures“ 

18 — 10 CFR 20.2003, “Disposal by release into sanitary sewerage” 

19 — 10 CFR 20.2004, “Treatment or disposal by incineration 

20 — 10 CFR 20.2005, “Disposal of specific wastes” 

21  records required by 10 CFR 20.2103(b)(4) of the results of measurements and 

22 calculations used to evaluate the release of radioactive effluents to the environment 
8-51 

In accordance with 10 CFR 37.11(c), a licensee that possesses radioactive waste that contains 

Category 1 or Category 2 quantities of radioactive material as defined in 10 CFR 37.5 is 

exempt from the requirements of 10 CFR Part 37, Subparts B, C, and D. However, any 

radioactive waste that contains discrete sources, ion-exchange resins, or activated material 

that weighs less than 2,000 kg (4,409 lbs) is not exempt from the requirements of 

10 CFR Part 37. 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.” 

A licensee possessing radioactive waste that is exempt under 10 CFR 37.11(c) from the 

requirements of 10 CFR Part 37, Subparts B, C, and D must implement the following 

requirements to secure the radioactive waste: 

 use continuous physical barriers that allow access to the radioactive waste only through 

established access control points; 

 use a locked door or gate with monitored alarm at the access control point; 

 assess and respond to each actual or attempted unauthorized access to determine 

whether an actual or attempted theft, sabotage, or diversion occurred; and 

 immediately notify the LLEA and request an armed response from the LLEA upon 

determination that there was an actual or attempted theft, sabotage, or diversion of the 

radioactive waste that contains Category 1 or Category 2 quantities of 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  Provide a statement that: “We will ensure that all licensed Special Nuclear Material shall 

3 be disposed of in accordance with the requirements of 10 CFR Part 20 Subpart K.” 

4 OR 

5  If access to a radioactive waste burial site is unavailable, the applicant should request 

6 authorization for extended interim storage of waste. Applicant should use the references 

7 listed below for guidance and submit the required information with the application. 

8 Note: Applicants do not need to provide information to the NRC if they plan to dispose of LLW 

9 via transfer to an authorized recipient. 

10 Alternative responses will be reviewed using the criteria listed above. 
8-52 

1 References: 

2  Information Notice 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste 

3 Generators on the Elements of a Waste Minimization Program,” dated March 1994. 

4  Information Notice 94-07, “Solubility Criteria for Liquid Effluent Releases to Sanitary 

5 Sewerage Under the Revised 10 CFR Part 20,” dated January 1994. 

6  Information Notice 84-94, “Reconcentration of Radionuclides Involving Discharges into 

7 Sanitary Sewage Systems Permitted Under 10 CFR 20.303 (now 10 CFR 20.2003),” 

8 dated December 1984. 

9  Information Notice 90-09, “Extended Interim Storage of Low-Level Radioactive Waste by 

10 Fuel Cycle and Materials Licensees,” dated February 1990. 

11  Regulatory Issue Summary 2008-12, “Considerations For Extended Interim Storage Of 

12 Low-Level Radioactive Waste By Fuel Cycle And Materials Licensees,” dated May 2008. 

13  Regulatory Issue Summary 2011-09, “Available Resources Associated With Extended 

14 Storage Of Low-Level Radioactive Waste,” dated August 2011. 

15  Regulatory Issue Summary 2016-11, “Requests to Dispose of Very Low-Level 

16 Radioactive Waste Pursuant to 10 CFR 20.2002,” November 13, 2016 

17 Information Notices and Regulatory Issue Summaries are available at 

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

19 Additional Reference: 

20  Policy and Guidance Directive PG 8-10, “Disposal of Incineration Ash as Ordinary 

21 Waste,” dated January 1997, ADAMS Accession Nos. ML003744979 and ML003752866 

22 and Addendum, ADAMS Accession Nos. ML003744984 and ML003744988. 

23 8.12 Item 12: License Fees 

24 On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of 

25 the fee enclosed with the application. 

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

27 Office of the Chief Financial Officer at NRC Headquarters in Rockville, MD, 301-415-7554. 

28 Information about fees may also be obtained by calling the NRC’s toll-free number, 

29 800-368-5642, extension 415-7554. The e-mail address for fees questions is 

30 Fees.Resource@nrc.gov. 

31 8.13 Item 13: Certification 

32 A representative of the corporation or legal entity filing the application should sign and date 

33 NRC Form 313. The representative signing the application must be authorized to make binding 

34 commitments and to sign official documents on behalf of the applicant. As discussed previously 

35 in Chapter 3, “Management Responsibility,” signing the application acknowledges 
8-53 

1 management’s commitment to and responsibility for the radiation protection program. The NRC 

2 will return all unsigned applications for proper signature. 

3 Notes: 

4  It is a criminal offense to knowingly and willfully make a false statement or 

5 representation on applications or correspondence (18 U.S.C. 1001). 

6  When the application references commitments, those items will be incorporated into the 

7 license and, therefore, 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 changed, the licensee must submit an application for 

4 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 under Title 10 of the Code of Federal Regulations (10 CFR) [10 CFR 2.109(a), 10 CFR 70.33, 

8 10 CFR 70.38(a)]. 

9 Applicants for license amendment or renewal should do the following: 

10  Use the most recent guidance in preparing an amendment or renewal request. 

11  Submit either a U.S. Nuclear Regulatory Commission (NRC) Form 313 or a letter 

12 requesting amendment or renewal. 

13  Provide the license number and docket number. 

14  For renewals, provide a complete and up-to-date application, including all required 

15 program elements outlined in Appendix B of this NUREG. Training documentation for 

16 personnel currently listed on the license does not need to be submitted as part of the 

17 renewal application. 

18 9.1 Timely Notification of Transfer of Control 

19 Regulation: 10 CFR 70.36 

20 Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

21 consent before transferring control of the license, also referred to as a “change of ownership” 

22 and/or “transferring the license.” 

23 Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

24 transfers. Although it is not the NRC’s intent to interfere with the business decisions of 

25 licensees, under 10 CFR 70.36 and the Atomic Energy Act, licensees must obtain prior NRC 

26 written consent before transferring control of the license to ensure the following: 

27  Radioactive materials are possessed, used, or controlled only by persons who have 

28 valid NRC licenses or Agreement State licenses. 

29  Materials are properly handled and secured. 

30  Persons using these materials are capable, competent, and committed to implementing 

31 appropriate radiological controls. 

32  A clear chain of custody is established to identify who is responsible for disposition of 

33 records and licensed material. 
9-2 

1  Adequate financial assurance is provided for compliance with applicable NRC 

2 requirements, if required. 

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

4 Response from Applicant: No response is required from an applicant for a new license. 

5 However, current licensees should refer to NUREG–1556, Volume 15, “Consolidated Guidance 

6 About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving 

7 Byproduct, Source, or Special Nuclear Materials Licenses,” for more information about transfer 

8 of control (i.e., ownership). 

9 Reference: For further information, see Regulatory Issue Summary 2014-08, Revision 1, 

10 “Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials 

11 Licenses,” dated May 5, 2016. This Regulatory Issue Summary can be found on the NRC’s 

12 Generic Communications Web page under “Regulatory Issue Summaries”: 

13 http://www.nrc.gov/reading-rm/doc-collections/gen-comm/
10-1 

1 10 APPLICATIONS FOR EXEMPTIONS 

2 Regulations: Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR 19.31, 

3 10 CFR 20.2301, 10 CFR 70.11, 10 CFR 71.12, 10 CFR 71.14 

4 Criteria: Licensees may request exemptions from the U.S. Nuclear Regulatory Commission 

5 (NRC) regulations. The licensee must demonstrate that the exemption is authorized by law; will 

6 not endanger life, property, or the common defense and security; and is otherwise in the public 

7 interest. Licensees may also use existing specific exemptions outlined in the 10 CFR 

8 regulations if they meet the established criteria. 

9 Discussion: Various sections of the NRC’s regulations address requests for exemptions 

10 (e.g., 10 CFR 19.31, “Application for exemptions;” 10 CFR 20.2301, “Applications for 

11 exemptions;” 10 CFR 70.11, “Persons using special nuclear material under certain Department 

12 of Energy and Nuclear Regulatory Commission contracts;” 10 CFR 71.12, “Specific 

13 exemptions;” and 10 CFR 71.14, “Exemption for low-level material”). These regulations state 

14 that the NRC may grant an exemption, acting on its own initiative or on an application from an 

15 interested person. 

16 Exemptions are not intended to revise regulations or to apply to large classes of licensees and 

17 are generally limited to unique situations. Requests for exemptions submitted to the NRC must 

18 identify the regulation for which the exemption is being requested and include a justification for 

19 the requested exemption. 

Unless the NRC has granted an exemption in writing, licensees must comply with all 

applicable regulations. 

11-1 

1 11 TERMINATION OF ACTIVITIES 

2 Regulations: Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR 70.25(g), 

3 10 CFR 70.38, 10 CFR 70.51(b) 

4 Criteria: The licensee must do the following: 

5  Notify the U.S. Nuclear Regulatory Commission (NRC), in writing, within 60 days of the 

6 occurrence of any of the following: 

7 — Expiration of its license 

— A decision to permanently cease principal activities1 8 at the entire site 

9 — For licensees subject to 10 CFR 70.38, a decision to permanently cease principal 

activities1 10 in any separate building or outdoor area 

— No principal activities1 11 under the license have been conducted for a period of 24 months 

— No principal activities1 12 have been conducted for a period of 24 months in any separate 

13 building or outdoor area that contains residual radioactivity such that the building or 

14 outdoor area is unsuitable for release according to NRC requirements. 

15  Submit a decommissioning plan, if required by 10 CFR 70.38(g). 

16  Conduct decommissioning, as required by 10 CFR 70.38(h) and 10 CFR 70.38(j). 

17  Submit to the appropriate NRC regional office a completed NRC Form 314, “Certificate 

18 of Disposition of Materials” (or equivalent information), and a demonstration that the 

19 premises are suitable for release for unrestricted use (e.g., results of final surveys and 

20 results of leak tests of sealed sources). 

21  Before a license is terminated, send the records important to decommissioning that are 

22 required by 10 CFR 70.25(g) to the appropriate NRC regional office in accordance with 

23 10 CFR 70.51(a)(3). 

24  Before a license is terminated, send records of disposal of licensed material made under 

25 10 CFR 20.2002; 10 CFR 20.2003, 20.2004, 20.2005; and the results of measurements 

26 and calculations used to evaluate the release of radioactive effluents to the environment 

27 to the appropriate NRC regional office, in accordance with 10 CFR 70.51(a)(1) and (2), if 

28 authorized to possess special nuclear material. 

29 Discussion: To comply with the above criteria, before a licensee can decide whether it must 

30 notify the NRC under 10 CFR 70.38(d), the licensee must determine whether residual 

31 radioactivity is present and, if so, whether the levels make the building or outdoor area 

 

1

‘Principal activities’ are activities which 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 unsuitable for release, according to NRC requirements. A licensee’s determination that a facility 

2 is not contaminated is subject to verification by NRC inspection. 

The permanent cessation of principal activities1 3 in an individual room or laboratory may require 

4 the licensee to notify the NRC if no other licensed activities are being performed in the building. 

5 This requirement also applies to buildings that were approved by the broad scope licensee as 

6 locations of use but not specifically named on the broad scope license. 

7 For information about requirements that apply to the timeliness of decommissioning, see 

8 Regulatory Issue Summary (RIS) 2015-19, Rev. 1, “Decommissioning Timeliness Rule 

9 Implementation and Associated Regulatory Relief,” dated September 27, 2016, which can be 

10 found on the NRC’s Generic Communications Web page under “Regulatory Issue Summaries”: 

11 http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2015/. 

12 For guidance on the disposition of licensed material, see Section 8.11 “Waste Management.” 

13 For guidance on decommissioning records, see Section 8.5.2, “Financial Assurance and 

14 Recordkeeping for Decommissioning.” 

15 NUREG–1757, “Consolidated Decommissioning Guidance,” contains the current regulatory 

16 guidance concerning decommissioning of facilities and termination of licenses. Licensees that 

17 have large facilities to decommission should review NUREG–1575, “Multi-Agency Radiation 

18 Survey and Site Investigation Manual (MARSSIM).” The computer code “DandD” offers an 

19 acceptable method for calculating screening values to demonstrate compliance with the 

20 unrestricted dose limits. Supplemental information on the implementation of the final rule on 

21 radiological criteria for license termination was published in the Federal Register (63 FR 64132) 

22 on November 18, 1998. 

23 Supplemental information on the implementation of the final rule on radiological criteria for 

24 license termination also was published in the Federal Register on December 7, 1999, 

25 (64 FR 68395) which addresses screening values in soils for the most common radionuclides, 

26 and in the FR on June 13, 2000, (65 FR 37186) for screening values for building surfaces and 

27 soils contaminated with radionuclides not addressed in the prior Federal Register notices. 

28 Response from Applicant: The applicant is not required to submit a response to the NRC 

29 during the initial application. The licensee’s obligations in this matter begin when the license 

30 expires or at the time the licensee ceases operations, whichever is earlier. These obligations 

31 are to undertake the necessary decommissioning activities, to submit NRC Form 314 or 

32 equivalent information, and to perform any other actions summarized in “Criteria” above. 

33 Reference: NRC Form 314 is available at 

34 http://www.nrc.gov/reading-rm/doc-collections/forms.
1 APPENDIX A 

2 U.S. NUCLEAR REGULATORY COMMISSION FORM 313

A–1 

1 U.S. Nuclear Regulatory Commission Form 313 

2 Please use the most current version of this form, which may be found at: 

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

4 

1 APPENDIX B 

2 SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

3 ITEMS 5 THROUGH 11 OF U.S. NUCLEAR REGULATORY COMMISSION 

4 FORM 313

B–1 

1 Suggested Format for Providing Information Requested in Items 5 

2 Through 11 of U.S. Nuclear Regulatory Commission Form 313 

3 The table below is designed to help applicants develop their applications. In some instances it 

4 is acceptable to simply indicate, by checking the box in the third column (Yes), that applicant 

5 commits to adopting the model procedures that are referenced. If the third column contains an 

6 asterisk (*), the licensee is expected to describe its program or submit its procedures for the 

7 particular item. In this instance, the applicant is requested to check the box in the fourth column 

8 indicating that the described program and/or procedures are attached to the application 

9 [U.S. Nuclear Regulatory Commission (NRC) Form 313]. If the third column contains an “N/A,” 

10 the licensee is not required to describe or submit its programs and/or procedures during the 

11 licensing phase. However, these program areas may be reviewed during an inspection. 

The table below may also be used as a License Reviewer checklist for applications for 

SNM licenses. 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. 

Item 

No. Suggested Response Yes 

Description 

Attached 

5. RADIOACTIVE MATERIAL 

Unsealed and/or Sealed Sources 

 For unsealed materials: 

— Provide element name with mass number, chemical 

and/or physical form, and maximum requested 

possession limit. 

— For each specified isotope, include the principle 

isotope and significant dose-contributing contaminants. 

For example, the quantity of Pu-236 present in Pu-238 

should be specified. 

 For sealed materials: 

— Identify each radionuclide(s) (element name and mass 

number) that will be used in each source. 

— Provide the manufacturer’s (distributor’s) name and 

model number for each sealed source and device 

requested. 

* 
B–2 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. 

Item 

No. Suggested Response Yes 

Description 

Attached 

— Confirm that each sealed source, device, and 

source/device combination is registered as an 

approved sealed source or device by NRC or an 

Agreement State. 

— Confirm that the activity per source and maximum 

activity in each device will not exceed the maximum 

activity listed on the approved certificate of registration 

issued by NRC or by an Agreement State. 

 Provide an Emergency Plan (if required). 

Financial Assurance and Recordkeeping for 

Decommissioning 

No response is needed from most applicants. If a certification of 

financial assurance for decommissioning financial assurance or a 

decommissioning funding plan (DFP) is required, submit the 

required documents as described in Regulatory Guide 3.66 

(NUREG–1757, Volume 1 and Volume 3).



6. PURPOSE FOR WHICH LICENSED MATERIAL WILL 

BE USED 

List the specific use or purpose of each radioisotope. * 

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM-RADIATION SAFETY OFFICER (RS0)-TRAINING 

AND EXPERIENCE 

 Provide the name of the proposed RSO. 

 Describe the proposed RSO’s training and experience 

specific to the licensed material that the applicant intends to 

use. 

 Provide the name of each proposed AU. 

 Provide information demonstrating that each proposed AU is 

qualified by training and experience to use the requested 

licensed materials.

* 

* 





 

(Continued) 
B–3 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. (Continued)

Item 

No. Suggested Response 

Yes

Description 

Attached

8. TRAINING FOR INDIVIDUALS WORKING IN OR 

FREQUENTING RESTRICTED AREAS (Occupationally 

Exposed Individuals and Ancillary Personnel) 

Submit a description of the radiation safety training program, 

including topics covered, groups of workers, assessment of 

training, qualifications of instructors, and the method and 

frequency of training and refresher training.

* 

9. FACILITIES AND EQUIPMENT 

Describe the facilities and equipment to be made available at 

each location where radioactive material will be used. Include a 

description of the area(s) assigned for the receipt, storage, 

preparation, and measurement of radioactive materials. Submit a 

diagram showing the locations of shielding, the proximity of 

radiation sources to unrestricted areas, and other items related to 

radiation safety. When applicable to facilities where radioactive 

materials may become airborne, the diagrams should contain 

schematic descriptions of the ventilation systems, with pertinent 

airflow rates, pressures, filtration equipment, and monitoring 

systems. Diagrams should be drawn to a specified scale, or 

dimensions should be indicated. For facilities where it is 

anticipated that more than one laboratory or room may be used, a 

generic laboratory or room diagram may be submitted.

* 

10. RADIATION SAFETY PROGRAM 

Audit Program 

The applicant is not required to, and should not, submit its audit 

program to NRC for review during the licensing phase. The 

adequacy of this audit program will be reviewed during the 

NRC inspection.

Need Not be 

Submitted with 

Application 

Radiation Monitoring Instruments 

We will use equipment that meets the radiation monitoring 

instrument specifications and implement the model survey meter 

calibration program published in Appendix F to the current 

version of NUREG–1556, Vol. 17, “Program-Specific Guidance 

About Special Nuclear Material of Less Than Critical Mass 


B–4 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. (Continued)

Item 

No. Suggested Response 

Yes

Description 

Attached

Licenses.” 

OR 

We will use equipment that meets the radiation monitoring 

instrument specifications published in Appendix F to the current 

version of NUREG–1556, Vol. 17, “Program-Specific Guidance 

About Special Nuclear Material of Less Than Critical Mass 

Licenses,” and instruments will be calibrated by other persons 

authorized by NRC, an Agreement State, or a licensing State to 

perform that service. 

OR 

A description of alternative minimum equipment to be used for 

radiation monitoring and/or alternative procedures for the 

calibration of radiation monitoring equipment.

 

Material Receipt and Accountability 

Develop a procedure(s) for ensuring material accountability. 

If applicable, provide the following statement: “We will comply 

with the National Source Tracking System (NSTS) reporting 

requirement as described in 10 CFR 20.2207.” 

Provide a statement that “We will develop, implement, and 

maintain procedures for ensuring accountability of licensed 

materials at all times.” 

AND 

Provide either of the following: 

A statement that: “Physical inventories will be conducted at 

intervals not to exceed 6 months, to account for all sealed 

sources and devices received and possessed under the license. 

Records of inventories will be maintained for 5 years from the 

date of each inventory and will include the radionuclides, 

quantities, manufacturer’s name, model numbers, and the date of 

the inventory.” 

OR 

* 








B–5 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. (Continued)

Item 

No. Suggested Response 

Yes

Description 

Attached

A description of procedures for ensuring that no sealed sources 

have been lost, stolen, of misplaced and how often this will be 

done. 

* 

Occupational Dose 

We will maintain, for inspection by the NRC, documentation 

demonstrating that unmonitored individuals are not likely to 

receive, in a year, a radiation dose in excess of 10 percent of the 

allowable limits in 10 CFR Part 20, or we will monitor individuals 

in accordance with the criteria in Section 8.10.4, “Radiation 

Safety Program—Occupational Dose” in the current version of 

NUREG–1556, Vol. 17, “Program-Specific Guidance About 

Special Nuclear Material of Less Than Critical Mass Licenses.”

Public Dose 

The applicant’s program to control doses received by individual 

members of the public will be examined during inspection, but 

should not be submitted in a license application.

Need Not be 

Submitted with 

Application 

Operating and Emergency Procedures 

Develop and maintain operating procedures for safe use and 

emergencies. State that such procedures have been developed. 

In addition, if you want the option to make changes to your 

operating and emergency procedures, state that procedures may 

be revised if: 

 The changes are consistent with the procedures submitted 

with the license application. 

 The changes are reviewed and approved by licensee 

management and the RSO. 

 Licensee staff is trained in the revised procedures before they 

are implemented. 

 The changes do not degrade the effectiveness of 

the program.

* 




B–6 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. (Continued)

Item 

No. Suggested Response 

Yes

Description 

Attached

Leak Test 

Leak tests will be performed at the intervals approved by the NRC 

or an Agreement State and specified in the SSD 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 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 

sealed source or plated foil manufacturer’s (distributor’s) and kit 

supplier’s instructions. 

OR 

Leak tests will be performed at the intervals approved by the NRC 

or an Agreement State and specified in the SSD 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 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 

sealed source or plated foil manufacturer’s (distributor’s) and kit 

supplier’s instructions. As an alternative, we will implement the 

model leak test program published in Appendix J to the current 

NUREG–1556, Vol. 17, “Program-Specific Guidance About 

Special Nuclear Material of Less Than Critical Mass Licenses.”





Survey 

We will survey our facility and maintain contamination levels in 

accordance with the survey frequencies and contamination levels 

published in Appendix I to the current NUREG–1556, Vol. 17, 

“Program-Specific Guidance About Special Nuclear Material of 

Less Than Critical Mass Licenses.”

Transportation 

The applicant’s program for transportation will be examined 

during inspection but should not be submitted in a 

license application.

Need Not Be 

Submitted with 

Application 
B–7 

Table B–1. Suggested Format for Providing Information Requested in Items 5 

Through 11 of NRC Form 313. (Continued)

Item 

No. Suggested Response 

Yes

Description 

Attached

Minimization of Contamination 

The applicant does not need to provide a response to this item 

under the following condition. The NRC will consider that the 

above criteria have been met if the applicant’s responses meet 

the criteria in (i) Section 8.5.1, “Radioactive Material—Sealed 

Sources and Devices or Unsealed Radioactive Material;” 

Section 8.9, “Facilities and Equipment;” Section 8.10.6, 

“Radiation Safety Program—Operating and Emergency 

Procedures;” Section 8.10.8, “Radiation Safety Program—

Surveys;” and Section 8.11, “Radiation Safety Program—Waste 

Management.”

Need Not Be 

Submitted with 

Application 

Security Program 

In accordance with 10 CFR Part 37, licensees that possess an 

aggregated Category 1 or Category 2 quantity of radioactive 

material must establish, implement, and maintain an access 

authorization program and a security program to ensure physical 

protection of the radioactive material.

Need not be 

submitted with 

application. 

Compliance with 

access authorization 

and security 

program 

requirements may 

be reviewed during 

NRC inspections 

11. WASTE MANAGEMENT 

We will ensure that all licensed Special Nuclear Material shall be 

disposed of in accordance with the requirements of 

10 CFR Part 20, Subpart K. 

OR 

If access to a radioactive waste burial site is unavailable, the 

applicant should request authorization for extended interim 

storage of waste. Applicant should use the references at the end 

of Section 8.11, “Waste Management” of this NUREG for 

guidance and submit the required information with the application.

Note: Applicants do not need to provide information to the NRC if 

they plan to dispose of LLW via transfer to an authorized 

recipient.







1 APPENDIX C 

2 TYPICAL DUTIES AND RESPONSIBILITIES OF THE 

3 RADIATION SAFETY OFFICER 

C–1 

1 Typical Duties and Responsibilities of the Radiation Safety Officer 

2 The radiation safety officer’s (RSO’s) duties and responsibilities include ensuring radiological 

3 safety and compliance with the U.S. Nuclear Regulatory Commission (NRC) and 

4 U.S. Department of Transportation (DOT) regulations and the conditions of the license. 

5 See Figure 8-4. Typically, these duties and responsibilities include the following: 

6  Ensure that licensed material possessed by the licensee is limited to the types and 

7 quantities of special nuclear material listed on the license. 

8  Ensure documentation is maintained to demonstrate, by measurement or calculation, 

9 that the total effective dose equivalent to the individual member of the public likely to 

10 receive the highest dose from the licensed operation does not exceed the annual limit in 

11 Title 10 of the Code of Federal Regulations (10 CFR) Part 20.1301, “Dose limits for 

12 individual members of the public.” 

13  Properly secure radioactive material. 

14  Ensure documents are posted as required by 10 CFR 19.11, “Posting of notices to 

15 workers” (10 CFR Part 19, license documents, operating procedures; NRC Form 3, 

16 “Notice to Employees”); and 10 CFR 21.6, “Posting Requirements” (10 CFR Part 21 

17 Section 206 of the Energy Reorganization Act of 1974, procedures adopted under 

18 Part 21), or a note is posted indicating where these documents can be examined. 

19  Ensure that licensed material is transported in accordance with all applicable NRC and 

20 DOT requirements. 

21  Ensure that radiation exposures are kept as low as is reasonably achievable (ALARA). 

22  Oversee all activities involving radioactive material, including monitoring and surveying 

23 all areas in which radioactive material is used. 

24  Ensure that up-to-date operating, emergency, and security procedures are developed, 

25 implemented, maintained, and distributed. 

26  Safety consequences of nonroutine operations are analyzed before conducting any such 

27 activities that have not been previously analyzed. 

28  Nonroutine operations are performed by the manufacturer, distributor, or person 

29 specifically authorized by the NRC or an Agreement State. 

30  Serve as a point of contact for the NRC’s, Agreement State’s, and licensee’s 

31 management during routine operations, emergencies, or incidents. 

32  Notify proper authorities of incidents, such as damage to sources/devices, loss of 

33 licensed material, fire, theft, etc. 

34  Investigate unusual occurrences, identify cause(s) and appropriate corrective action(s), 

35 and take timely corrective action(s) to prevent recurrence. 
C–2 

1  Ensure that possession; installation; relocation; use; storage; repair; and maintenance of 

2 sealed sources, devices, and radioactive wastes are consistent with the limitations in the 

3 license, individual Sealed Source and Device Registration Certificate(s), and the 

4 manufacturer’s specific recommendations and instructions. 

5  Provide necessary information on all aspects of radiation protection to personnel at all 

6 levels of responsibility, pursuant to 10 CFR Part 19 and 20 and any other 

7 applicable regulations. 

8  Oversee proper delivery, receipt, and conduct of radiation surveys for all shipments of 

9 radioactive material arriving at or leaving from the facility, as well as packaging and 

10 labeling all radioactive material leaving the facility. 

11  Prospective evaluations are performed to demonstrate that unmonitored individuals are 

12 not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502(a) or that 

13 personnel monitoring devices are provided. 

14  Determine the need for personnel monitoring, distribute and collect personnel radiation 

15 monitoring devices, evaluate bioassays, monitor personnel radiation exposure and 

16 bioassay records for trends and high exposures, notify individuals and their supervisors 

17 of radiation exposures approaching the limits, and recommend appropriate remedial 

18 action. Record and maintain the results of such monitoring. 

19  Ensure that individuals involved with using radioactive materials are properly trained 

20 and evaluated. 

21  Supervise and coordinate the radioactive waste disposal program, including effluent 

22 monitoring and recordkeeping on waste storage and disposal records. 

23  Ensure licensed material is disposed of properly. 

24  Oversee the storage of radioactive material not in current use, including waste. 

25  Perform/oversee the inventory and leak testing on all sealed sources. 

26  Perform/oversee the inventory and calibration of radiation survey instruments. 

27  Maintain an inventory of all radioisotopes possessed under the license and limit the 

28 quantity to the amounts authorized by the license. 

29  Stop activities involving licensed material that the radiation safety officer (RSO) 

30 considers unsafe. 

31  Supervise decontamination and recovery operations. 

32  For licensees possessing an aggregated Category 1 or Category 2 quantity of 

33 radioactive material, participate in the development and implementation of a security 

34 program for radioactive material in accordance with 10 CFR Part 37. A “Category 1 

35 quantity of radioactive material” and a “Category 2 quantity of radioactive material” are 

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

37 definitions are listed in Appendix A to 10 CFR Part 37. 
C–3 

1  Maintain required records that are necessary to support the license and satisfy NRC or 

2 Agreement States regulations. 

3  Perform periodic audits, at least annually, of the radiation safety program to ensure that 

4 the licensee is complying with all applicable NRC regulations and the terms and 

5 conditions of the license. 

6  Ensure that the results of audits, identification of deficiencies, and recommendations for 

7 change are documented (and maintained for 3 years after the record is made) and 

8 provided to management for review; ensure that prompt action is taken to correct 

9 deficiencies. 

10  Ensure that the audit results and corrective actions are communicated to all personnel 

11 who use licensed material. 

12  When the licensee identifies violation(s) of regulations or license conditions or program 

13 weaknesses, corrective action(s) are developed, implemented, and documented. 

14  Ensure that all incidents, accidents, and personnel exposure to radiation in excess of 

15 ALARA or 10 CFR Part 20 limits are investigated and reported to NRC and other 

16 appropriate authorities, if required, within the required time limits. 

17  Maintain understanding of and up-to-date copies of NRC regulations, the license, 

18 revised licensee procedures, and ensure that the license is amended whenever there 

19 are changes in licensed activities, responsible individuals, or information or 

20 commitments provided to the NRC during the licensing process. 

21  Submit amendment and renewal requests in a timely manner. 

 
C–4 

1 Model Delegation of Authority to RSO 

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 D 

2 FACILITIES AND EQUIPMENT CONSIDERATIONS

D–1 

1 Facilities and Equipment Considerations 

2 Below is a list of topics that should be considered when developing a description of the facilities 

3 and equipment that a licensee will use, or otherwise have available. Not every applicant will 

4 need to address each topic in their application. 

5  Restricted areas are defined as areas to which access is limited by the licensee to 

6 protect individuals against undue risks from exposure to radiation and radioactive 

7 materials. The application should contain detailed descriptions and diagrams of the 

8 facilities, including information about the shielding properties of the construction 

9 materials used. Scaled drawings and sketches should be submitted showing the 

10 relationship between restricted areas and unrestricted areas and the location of all 

11 pertinent safety-related equipment. 

12  Security zones are defined as any temporary or permanent area determined and 

13 established by the licensee for the physical protection of aggregated Category 1 or 

14 Category 2 quantities of radioactive material listed in Appendix A to 10 CFR Part 37. 

15 The security zone should be designed so that the licensee can monitor, detect without 

16 delay, assess, and respond to any unauthorized entries into security zones and any 

17 unauthorized removal of radioactive material from the security zone. Monitoring and 

18 detection systems may include video surveillance systems and electronic devices for 

19 intrusion detection alarms. 

20  Bench-top or open work areas may be used for sealed sources, for small quantities of 

21 solid materials in a form not likely to become airborne or dispersed, and for small 

22 quantities of liquids of such low volatility as not to cause airborne contamination or 

23 toxicity problems. Trays or absorbent surface covers to catch and retain spilled liquids 

24 should be used on these open work surfaces and inside closed systems. Surfaces 

25 should be smooth and non-porous, to facilitate decontamination. 

26  Radioactive materials that are handled or used in unsealed forms should be confined to 

27 control the release of material and to prevent the spread of contamination. Gaseous, 

28 volatile, and fine particulate solid materials should be handled in closed or isolated 

29 systems, such as fume hoods or glove boxes with controlled, and possibly filtered, 

30 exhaust systems. Ventilation systems for these facilities should be designed so that 

31 airborne radioactive material work areas are at negative pressure compared to non32 radioactive work areas. 

33  Chemical-type fume hoods provide a working area with controlled inward airflow from 

34 the room to the hood exhaust system. Hoods are used for gases, for unsealed volatile 

35 licensed materials, and for processes such as evaporation that may release gases and 

36 vapors. Fume hoods provide emergency ventilation and exhaust for unplanned 

37 releases, such as accidental spills and ruptures, as well as routine exhaust of effluents. 

38 Filters may be required in the exhaust stream unless monitoring and/or calculations 

39 demonstrate that any planned or likely effluent will be in accordance with the limits found 

40 in Title 10 of the Code of Federal Regulations (10 CFR) Part 20, Appendix B. 

41  Glove boxes are sealed boxes with transparent viewing windows, sealable ports or 

42 doors for transferring materials and equipment, and gloves sealed to the box through 

43 which licensed materials are handled. Glove boxes are used for the containment during 

44 storage and use of liquids and solids that can become airborne particulates or aerosols. 
D–2 

1 Glove boxes can be closed or exhausted, with filtration systems if appropriate, to prevent 

2 contamination. 

3  For the most efficient operation of hoods and glove boxes, minimize storage of materials 

4 and equipment inside the work areas. 

5  Sink faucets should be designed, where possible, for operation by foot, knee, or elbow 

6 rather than by hand. 

7  Plumbing and ductwork should be designed to avoid radioactive contamination build-up. 

8 This build-up of contamination can create external radiation exposure hazards and 

9 problems for decommissioning. 

10  To reduce radiation exposure from gamma-emitting radioactive materials, shielding 

11 consisting of lead or other high-density material in the form of bricks, panels, L-shields, 

12 storage containers, or other shapes may be used on bench tops, in fume hoods, or in 

13 glove boxes. 

14  To reduce the exposure from high-energy beta-emitting materials, shielding of low 

15 atomic number material, such as high-density plastic, may be used. 

16  Shielded shipping containers frequently are used for continued storage after receipt 

17 of materials. 

18  A particular sink should be designated for disposal of liquid radioactive waste to the 

19 sanitary sewerage system. In some cases, depending on the number of users and 

20 distance between areas of use, more than one sink may need to be designated. 

21  Labeled waste containers should be used. These containers may be shielded as 

22 necessary, placed near the waste-generating areas and away from areas frequently 

23 occupied by personnel. Additionally, these containers should be effectively enclosed to 

24 prevent airborne contamination from radioactive materials deposited. If radioactive 

25 waste materials are volatile, the containers should be stored in ventilated areas. 

26  Remote handling tools, such as forceps or extension handles, should be used to provide 

27 distance in the handling of radioactive materials (ALARA). In addition, shielded handling 

28 devices, such as shielded syringes, can be used to protect workers from materials that 

29 cannot be handled remotely. Pipetting should be done using only appropriate devices. 

30 Pipetting by mouth should be strictly forbidden. 

31  Where appropriate, ventilation systems should be designed such that, in the event of an 

32 accident, they can be shut down to prevent the spread of radioactivity. If appropriate, 

33 supply and exhaust fans can be interlocked such that if exhaust fans shutdown, the 

34 shutdown of supply fans is also triggered; this interlock system is to prevent laboratory 

35 and work areas from becoming positively pressurized with respect to the surrounding 

36 parts of the facility. 

37  Designated areas should be provided for coats and personal belongings, to 

38 avoid contamination. 
D–3 

1  Areas with background radiation levels should be designated for personnel dosimetry 

2 storage when not in use. 

3  Areas of use should be well-lighted to avoid spills and other accidents that could result in 

4 contamination build-up. 

5  Observation of activities conducted behind shielding with remote tools (or with extended 

6 arms and hands, within limits consistent with permissible occupational exposures) can 

7 be accomplished by mirrors, through shielded (e.g., leaded glass) windows, through 

8 transparent plastic beta shields, or by remote video monitoring. 

9  The combination of containment, shielding, and handling devices proposed for any use 

10 of radioactive materials should be appropriate to the type and quantity of materials to be 

11 used and to the type and duration of operations to be conducted. 

12  If respiratory protective equipment will be used to limit inhalation of airborne licensed 

13 material, follow the provisions of 10 CFR Part 20, Subpart H, “Respiratory protection and 

14 controls to restrict internal exposure in restricted areas.” 

15  If compaction of waste is performed, ensure that facilities are adequate for the ventilation 

16 of the area where the waste is compacted. In addition, also ensure that air sampling for 

17 internal exposures is available, if needed, per 10 CFR 20.1204, “Determination of 

18 internal exposure.” 

19  Adequate air and/or water effluent monitoring equipment should be used to demonstrate 

20 compliance with the limits found in 10 CFR Part 20, Appendix B, if applicable, and tested 

21 for operability at the frequency established by the manufacturer. 

1 APPENDIX E 

2 SUGGESTED AUDIT CHECKLIST

E–1 

1 Suggested Audit Checklist 

2 An audit is conducted, in part, to fulfill the requirements of Title 10 of the Code of Federal 

3 Regulations (10 CFR) 20.1101, “Radiation protection programs,” for an annual review of the 

4 content and implementation of the licensee’s radiation protection program. It should also 

5 identify program weaknesses and allow licensees to take early corrective actions (before a 

6 U.S. Nuclear Regulatory Commission (NRC) inspection). During an audit, the auditor needs to 

7 keep in mind not only the requirements of NRC’s regulations, but also the licensee’s 

8 commitments in its applications and other correspondence with NRC. The auditor should also 

9 evaluate whether the licensee is maintaining exposures to workers and the general public as 

10 low as is reasonably achievable (ALARA) and, if not, make suggestions for improvement. 

11 The form in this appendix can be used to document the annual audit of the radiation protection 

12 program. Guidance follows on completing each section of the form. In the “remarks” portions of 

13 the form, note any deficiencies that were identified and the corrective actions taken 

14 (or to be taken). 

15 Section 1, Audit History. Enter the date of the last audit, whether any deficiencies were 

16 identified, and whether actions were taken to correct the deficiencies. 

17 Section 2, Organization and Scope of Program. Give a brief description of the organizational 

18 structure, noting any changes in personnel. Describe the scope of licensed activities at the 

19 audited location. Check whether the Radiation Safety Officer (RSO) is the person identified in 

20 the license and fulfills the duties specified in the license. Ensure use by authorized individuals. 

21 Section 3, Training, Retraining, and Instructions to Workers. Ensure that workers have received 

22 the training required by 10 CFR 19.12. Be sure that, before being permitted to use licensed 

23 material, the user has received training and has a copy of the licensee’s safe use and 

24 emergency procedures. Note whether refresher training is conducted in accordance with 

25 licensee commitments. By interview and/or observation of selected workers, ensure that each 

26 has a copy of the licensee’s procedures and can implement them properly. 

27 Section 4, Operating and Emergency Procedures. Verify that operating and emergency 

28 procedures are current, contain specified information, and were submitted to the NRC. 

29 Determine if any accidents occurred. If accidents occurred, determine if they were handled 

30 properly, and if corrective actions and notifications or reports were required and made. 

31 Section 5, Audits. Verify that audits fulfill the requirements of 10 CFR 20.1101, are conducted in 

32 accordance with licensee commitments, and are properly documented. 

33 Section 6, Facilities. Verify that the licensee’s facilities are as described in its license 

34 documents. 

35 Section 7, Materials. Verify that the license authorizes the quantities and types of material that 

36 the licensee possesses. 

37 Section 8, Leak Tests. Verify that all sealed/plated foil sources are tested for leakage at the 

38 prescribed frequency and in accordance with licensee commitments. Records of results should 

39 be maintained. 
E–2 

1 Section 9, Inventories. Verify that inventories are conducted at least once every 6 months to 

2 account for all sources; inventory records should be maintained and include the radionuclides, 

3 nominal activity (or quantity), manufacturer’s name and model number, serial number, location 

4 of each source, name of individual who performed inventory and the date of the inventory. 

5 Section 10, Radiation Surveys. Verify that the licensee has appropriate, operable and 

6 calibrated survey instruments available, that the instruments are calibrated (at the required 

7 frequency) in accordance with license conditions and in accordance with 10 CFR 20.2103, 

8 “Records of surveys.” Calibration records must be retained for 3 years after the record is made. 

9 Check that radiation levels in areas adjacent to use are within regulatory limits and in 

10 accordance with 10 CFR 20.2103. Verify compliance with 10 CFR 20.1301. Records of 

11 surveys must be retained for 3 years after the record is made. 

12 Section 11, Receipt and Transfer of Radioactive Material (Includes Waste Disposal). Verify that 

13 packages containing licensed material received from others are received, opened, and surveyed 

14 in accordance with 10 CFR 20.1906. Ensure that transfers of material are performed in 

15 accordance with 10 CFR 70.42. Records of surveys must be maintained in accordance with 

16 10 CFR 20.2103. 

17 Section 12, Transportation (10 CFR 71.5(a) and 49 CFR 170-189). Determine compliance with 

18 Department of Transportation (DOT) requirements. Verify that radioactive packages are 

19 prepared, marked, and labeled in accordance with 49 CFR Parts 172 and 173 requirements. 

20 Verify that shipping papers are prepared, that they contain all needed information, and that they 

21 are readily accessible during transport (49 CFR 172.200, 201, 202, 203, 204, and 177.718). 

22 Section 13, Personnel Radiation Protection. ALARA considerations are incorporated into the 

23 Radiation Protection Program as required in 10 CFR 20.1101(b). Evaluate the licensee’s 

24 determination that unmonitored personnel are not likely to receive more than 10 percent of the 

25 allowable limits in 10 CFR 20.1501(c). Alternately, if personnel dosimetry is provided and 

26 required, verify that it complies with 10 CFR 20.1501(c) and licensee commitments. Review 

27 personnel monitoring records; compare exposures of individuals doing similar work; determine 

28 reasons for significant differences in exposures. If any worker declared her pregnancy in 

29 writing, evaluate the licensee’s compliance with 10 CFR 20.1208, “Dose equivalent to an 

30 embryo/fetus.” Check whether records are maintained as required by 10 CFR 20.2101, 

31 “General provisions;” 10 CFR 20.2102, “Records of radiation protection programs;” 10 CFR 

32 20.2103, “Records of surveys;” 10 CFR 20.2104, “Determination of prior occupational dose;” 

33 and 20.2106, “Records of individual monitoring results;” and 10 CFR 20.2201, “Reports of theft 

34 or loss of licensed material.” 

35 Section 14, Auditor’s Independent Measurements (If Applicable). Make independent survey 

36 measurements and compare the results with those made or used by the licensee. 

37 Section 15, Radioactive Effluents, Waste Management, and Disposal. Determine if radioactive 

38 effluents and radioactive waste are properly disposed and records maintained. 

39 Section 16, Notification and Reports. Check on the licensee’s compliance with the notification 

40 and reporting requirements in 10 CFR Parts 19, 20, and 70. Ensure that the licensee is aware 

41 of the telephone number for NRC’s Emergency Operations Center, which is 301-816-5100. 
E–3 

1 Section 17, Posting and Labeling. Check for compliance with the posting and labeling 

2 requirements of 10 CFR 19.11; 10 CFR 20.1902, “Posting requirements;” 10 CFR 20.1904, 

3 “Labeling containers;” and 10 CFR 21.6. 

4 Section 18, Recordkeeping for Decommissioning. Check to determine compliance with 

5 10 CFR 70.25(g). 

6 Section 19, NRC Correspondence. Check to determine if the licensee is receiving regulatory 

7 issue summaries, bulletins, information notices, Office of Nuclear Material Safety and 

8 Safeguards newsletters, etc., from the NRC. Check if the licensee took appropriate action in 

9 response to NRC mailings. 

10 Section 20, Special License Conditions or Issues. Verify compliance with any special conditions 

11 on the licensee’s license. If the licensee has any unusual aspect of its work, review and 

12 evaluate compliance with regulatory requirements. 

13 Section 21, Continuation of Report Items. This section is self-explanatory. 

14 Section 22, Problems or Deficiencies Noted; Recommendations. This section is 

15 self-explanatory. 

16 Section 23, Evaluation of Other Factors. Evaluate licensee management’s involvement with the 

17 radiation safety program, whether the RSO has sufficient time to perform his/her duties, and 

18 whether the licensee has sufficient staff to handle the workload and maintain compliance with 

19 regulatory requirements. 

20 Section 24, Security of Radioactive Materials (if applicable). Review the Physical Protection 

21 Program to verify compliance with 10 CFR Part 37, “Physical Protection of Category 1 and 

22 Category 2 Quantities of Radioactive Material.” Also, review the physical protection system to 

23 ensure compliance with 10 CFR 73.67, if the 10 CFR Part 73, “Physical Protection of Plants and 

24 Materials” requirements are applicable (see Section 8.10.11.1 of this NUREG). 

25 Section 25, Performance-based Review. Performance-based reviews may be conducted by 

26 observing work in progress, interviewing staff, and spot-checking required records. As a part of 

27 the audit program, consider performing unannounced audits to determine if, for example, 

28 procedures are available and are being followed for certain activities. 

29 Note: All areas indicated in audit notes may not be applicable to every license and may not 

30 need to be addressed during each audit. 
E–4 

1 SAMPLE CHECKLIST 

2 Audit Report No._____________________ License No. __________________________ 

3 Licensee’s name and mailing address: 

4 _______________________________ 

5 _______________________________ 

6 _______________________________ 

7 _______________________________ 

8 Audit of activities at (Address): 

9 _______________________________ 

10 _______________________________ 

11 _______________________________ 

12 _______________________________ 

13 Contact at Audit Location ______________ Telephone No. _______________________ 

14 Date of this Audit ___________________ 

15 Summary of Findings and Action: 

16  No deficiencies 

17  Deficiencies 

18  Action on previous deficiencies 

19 Recommendations: 

20 Auditor ______________________________ Date _____________________________ 

21 (Signature) 
E–5 

1 Note: Except where noted, references are to Title 10 of the Code of Federal Regulations 

2 (10 CFR). 

3 1. AUDIT HISTORY  N/A (N/A means “Not applicable” – Initial Audit) 

4 A. Last audit of this location conducted 

5 B. Problems/deficiencies identified during last two audits 

6 or two years, whichever is longer  Y  N 

7 C. Open problems/deficiencies from previous audits: 

8 Status Requirement Prob./Def. Corrective Action Taken (Y/N) Open/Closed 

9 ______________________________________________________________________ 

10 ______________________________________________________________________ 

11 ______________________________________________________________________ 

12 ______________________________________________________________________ 

13 ______________________________________________________________________ 

14 D. Any previous problem/deficiency not corrected 

15 or repeated  Yes  No  N/A 

16 Explain: 

17 2. ORGANIZATION AND SCOPE OF PROGRAM 

18 A. Briefly describe organizational structure and note any personnel changes. 

19 1. Structure is as described in license documents? Yes  No 

20 2. Multiple authorized locations of use?  Yes  No 

21 3. Briefly describe scope of activities involving licensed material, 

22 frequency of use, staff size, etc. 

23 B. Radiation Safety Officer  Yes  No 

24 1. Authorized on license  Yes  No 

25 2. Fulfills duties as RSO  Yes  No 

26 C. Use only by authorized individuals Yes  No 

27 D. Commensurate security program implemented Yes  No 

28 Remarks: 
E–6 

1 3. TRAINING, RETRAINING, AND INSTRUCTIONS TO WORKERS 

2 A. Instructions to workers per [10 CFR 19.12]  Yes  No 

3 B. Training program required  Yes  No 

4 C. Training records maintained  Yes  No 

5 D. Evaluation of individuals’ understanding of procedures and 

6 regulations based on interviews, observation of 

7 selected workers  Yes  No 

8 1. Each has an up-to-date copy of the licensee’s safe 

9 use and emergency procedures  Yes  No 

10 2. Adequate understanding of: 

11 a. Current safe use procedures  Yes  No 

12 b. Emergency procedures  Yes  No 

13 E. 10 CFR Part 20 

14 Workers cognizant of requirements for: 

15 1. Radiation Protection Program [20.1101]  Yes  No 

16 2. Annual dose limits [20.1301, 20.1302]  Yes  No 

17 3. NRC Forms 4 and 5  Yes  No 

18 4. 10 percent monitoring threshold [20.1502]  Yes  No 

19 5. Dose limits to embryo/fetus and declared 

20 pregnant women [20.1208]  Yes  No 

21 6. Procedures for opening packages [20.1906]  Yes  No 

22 Remarks: 
E–7 

1 4. OPERATING AND EMERGENCY PROCEDURES 

2 A. Procedures current?  Yes  No 

3 B. Procedures contain information specified  Yes  No 

4 C. Procedures submitted to the NRC  Yes  No 

5 D. Did any incidents or events occur?  Yes  No 

6 1. If so, were they handled properly?  Yes  No  N/A 

7 2. Were appropriate corrective actions taken?  Yes  No  N/A 

8 3. Was NRC notification or reporting required?  Yes  No  N/A 

9 [10 CFR 20.2201, 20.2202, 20.2203 and 30.50] 

10 Remarks: 

11 5. INTERNAL AUDITS, REVIEWS OR INSPECTIONS 

12 A. Audits are conducted  Yes  No 

13 1. Audits conducted by __________________________________________ 

14 2. Frequency __________________________________________________ 

15 B. Content and implementation of the radiation protection 

16 program reviewed annually [20.1101(c)]  Yes  No 

17 C. Records maintained [20.2102]  Yes  No 

18 6. FACILITIES 

19 A. Facilities as described in license application  Yes  No 

20 B. Access to restricted area/licensed material 

21 [20.1801,20.1802]  Yes  No 

22 Remarks: 

23 7. MATERIALS 

24 A. Isotopes, quantities, and use as authorized on license  Yes  No 

25 B. Using NUREG–1757, Volume 3: Financial Assurance 

26 is current [30.35, 70.25]  Yes  No  N/A 

27 Remarks: 
E–8 

1 8. LEAK TESTS 

2 A. Leak test performed as described in correspondence 

3 With NRC (consultant; leak test kit; licensee performed)  Yes  No 

4 B. Frequency: every 6 months or other interval, as approved 

5 by NRC or Agreement State  Yes  No 

6 C. Records with appropriate information maintained  Yes  No 

7 Remarks: 

8 9. INVENTORIES 

9 A. Conducted at 6-month intervals  Yes  No 

10 B. Visual verification confirmed or security seal still in place  Yes  No 

11 C. Transactions entered into the National Source 

12 Tracking System, Including annual reconciliation [20.2207]  Yes  No  N/A 

13 D. Records with appropriate information maintained  Yes  No 

14 Remarks: 

15 10. RADIATION SURVEYS 

16 A. Instruments and Equipment:  Yes  No 

17 1. Appropriate operable survey instrumentation 

18 possessed or readily available  Yes  No 

19 2. Calibrated as required [20.1501]  Yes  No 

20 3. Calibration records maintained [20.2103(a)]  Yes  No 

21 B. Briefly describe survey requirements [20.1501(a)]: 

22 C. Performed as required [20.1501(a)]  Yes  No 

23 1. Radiation levels within regulatory limits  Yes  No 

24 2. Corrective action taken and documented  Yes  No 

25 D. Records maintained [20.2103]  Yes  No 

26 E. Protection of members of the public 

27 1. Adequate surveys made to demonstrate either (a) that 

28 the TEDE to the individual likely to receive the highest 

29 dose does not exceed 100 mrem in a year, or (b) that if an 

30 individual were continuously present in an unrestricted area, 
E–9 

1 the external dose would not exceed 2 mrem in any hour and 

2 50 mrem in a year [20.1301(a)(1), 1302(b)]  Yes  No 

3 2. Unrestricted area radiation levels do not exceed 

4 2 mrem in any one hour [20.1301(a)(2)]  Yes  No 

5 3. Records maintained [20.2103, 2107]  Yes  No 

6 Remarks: 

7 11. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL (INCLUDES WASTE 

8 DISPOSAL) 

9 A. Describe how packages are received and by whom: 

10 B. Written package opening procedures established and 

11 followed [20.1906(e)]  Yes  No 

12 C. If package shows evidence of degradation, monitor for 

13 contamination and radiation levels  Yes  No  N/A 

14 D. Monitoring of degraded packages performed within time 

15 specified [20.1906(c)]  Yes  No  N/A 

16 E. Transfer(s) between licensees (including “disposal”) 

17 performed per 70.36 and 70.42  Yes  No  N/A 

18 F. Records of receipt/transfer maintained 

19 [20.2103(a), 70.51(b)(1)]  Yes  No 

20 G. Transfers within licensee’s authorized users or locations  Yes  No  N/A 

 performed as required [L/C1 21 ] 

22 H. Package receipt/distribution activities evaluated for 

23 compliance with 20.1301 [20.1302]  Yes  No  N/A 

24 Remarks: 

25 12. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170-189)  N/A 

26 A. Licensee shipments are: 

27 1. Delivered to common carriers  Yes  No  N/A 

28 2. Transported in licensee’s own private vehicle  Yes  No  N/A 

29 3. No shipments since last audit  Yes  No  N/A 

30 B. Hazmat Training 

 

1

L/C refers to license condition. 
E–10 

1 1. Applicability and responsibility for training and 

2 testing [49 CFR 172.702]  Yes  No  N/A 

3 2. Training requirements [49 CFR 172.704]  Yes  No  N/A 

4 C. Packages  N/A 

5 1. Authorized packages used [49 CFR 173.415, 416(b)]  Yes  No  N/A 

6 2. Closed and sealed during transport 

7 [49 CFR 173.475(f)]  Yes  No 

8 3. Properly labeled and marked 

9 [49 CFR 172.403, 441, 173.471]  Yes  No  N/A 

10 D. Shipping Papers  N/A 

11 1. Prepared and used [49 CFR 172.200(a)]  Yes  No 

12 2. Proper [Shipping name, Hazard Class, UN Number, 

13 Quantity, Package Type, Nuclide, RQ, Radioactive 

14 Material, Physical and Chemical Form, Activity, 

15 Category of label, TI, Shipper’s Name, Certification and 

16 Signature, Emergency Response Phone Number, “Cargo 

17 Aircraft Only” (if applicable)] [49 CFR 172.200-204]  Yes  No 

18 3. Readily accessible during transport 

19 [49 CFR 177.817(e)]  Yes  No 

20 E. Vehicles  Yes  No 

21 1. Cargo blocked and braced [49 CFR 177.842(d)]  Yes  No 

22 2. Placarded, if needed [49 CFR 172.504]  Yes  No 

23 3. Proper overpacks, if used (shipping name, UN Number, 

24 labeled, statement indicating that inner package 

25 complies with specification package) [49 CFR 173.25]  Yes  No 

26 F. Security Plans  N/A 

27 1. Components of a security plan [49 CFR 172.802]  Yes  No 

28 G. Any incidents reported to DOT [49 CFR 171.15, 171.16]  Yes  No 

29 Remarks: 

30 13. PERSONNEL RADIATION PROTECTION 

31 A. ALARA considerations are incorporated into the 

32 Radiation Protection Program [20.1101(b)]  Yes  No 

33 B. Adequate documentation of determination that 
E–11 

1 unmonitored occupationally individuals are not likely 

2 to receive >10% of allowable limit [20.1502(a)]  Yes  No  N/A 

3 OR 

4 C. External dosimetry provided and required  Yes  No  N/A 

5 1. Supplier____________________ Frequency_________________ 

6 2. Supplier is NVLAP-approved [20.1501(c)]  Yes  No 

7 3. Dosimeters exchanged at required frequency [L/C]]  Yes  No 

8 D. Occupational intake monitored and assessed [20.1502(b)]  Yes  No  N/A 

9 E. Reports  N/A 

10 1. Reviewed by_________________ Frequency_________________ 

11 2. Auditor reviewed personnel monitoring records for period_____ to_____ 

12 3. Prior dose determined for individuals likely to receive 

13 doses [20.2104]  Yes  No 

14 4. Maximum exposures TEDE_______________ Other_______________ 

15 5. NRC Forms or equivalent [20.2104(d), 2106(c)] 

16 a. NRC Form 4 “Cumulative Occupational 

17 Exposure History”  Yes  No 

18 Complete:  Yes  No 

19 b. NRC Form 5 “Occupational Exposure Record 

20 for a Monitoring Period”  Yes  No 

21 Complete:  Yes  No 

22 6. Worker declared her pregnancy in writing during 

23 inspection period (review records)  Yes  No  N/A 

24 If yes, determine compliance with [20.1208]  Yes  No 

25 Check for records per [20.2106(e)]  Yes  No 

26 F. Records of exposures, surveys, monitoring, and 

27 evaluations maintained [20.2102, 2103, 2106, L/C]  Yes  No 

28 Remarks: 
E–12 

1 14. AUDITOR’S INDEPENDENT MEASUREMENTS (IF MADE) 

2 A. Survey instrument Serial No. Last calibration 

3 ________________________________________________________ 

4 B. Auditor’s measurements compared to licensee’s  Yes  No 

5 C. Describe the type, location, and results of measurements: 

6 15. RADIOACTIVE EFFLUENTS, WASTE MANAGEMENT, AND DISPOSAL 

7 A. Licensed material released into sanitary sewerage:  N/A 

8 1. Material is readily soluble (or is readily dispersible 

9 biological material) in in water [20.2003(a)(1)]  Yes  No 

10 2. Monthly average release concentrations do not 

11 exceed Appendix B values [20.2003(a)(2,3)]  Yes  No 

12 3. Procedures for ensuring adequate sample 

13 representativeness and analysis properly implemented 

14 [20.1501, L/C]  Yes  No 

15 4. Records maintained [20.2108]  Yes  No 

16 Remarks: 

17 B. Transfers for disposal at land disposal facilities:  N/A 

18 1. Waste transferred to person specifically licensed 

19 to receive waste [20.2001(b), 70.42]  Yes  No 

20 2. Each shipment accompanied by a shipment manifest 

21 prepared as specified in Section I of Appendix G to 

22 10 CFR Part 20 [20.2006(b) and Section III.A.4 of 

23 Appendix G to 10 CFR Part 20]  Yes  No 

24 3. Shipment manifests certified as specified in Section II 

25 if Appendix G to 10 CFR Part 20 [20.2006(c)]  Yes  No 

26 4. Compliance with Section III of Appendix G to 

27 10 CFR Part 20 [20.2006(d)] 

28 a. Liquid wastes solidified [61.56(a)]  Yes  No 

29 b. Volume of solid wastes contain less than 1% 

30 free standing liquid [61.56(a)(3)]  Yes  No 

31 c. Waste does not generate harmful vapors [61.56(a)]  Yes  No 

32 d. Waste structurally stable (i.e. will maintain its 
E–13 

1 physical dimensions and form under expected 

2 disposal conditions [61.56(b)]  Yes  No 

3 e. Void spaces within the waste and between the 

4 waste and its package minimized [61.56(b)]  Yes  No 

5 5. Waste packages labeled to identify their proper class 

6 [Section III.A.2 of Appendix G to 10 CFR Part 20]  Yes  No 

7 6 Licensee conducts a Quality Assurance program to 

8 ensure compliance with 10 CFR 61.55 and 

9 10 CFR 61.56, and which includes management 

10 evaluation of audits [Section III.A.3 of Appendix G to 

11 10 CFR Part 20]  Yes  No 

12 7. For shipments not acknowledged by recipient within 

13 20 days after transfer, incident investigated and reported 

14 [Section III.A.9 of Appendix G to 10 CFR Part 20]  Yes  No 

15 8. Records maintained [20.2108]  Yes  No 

16 Remarks: 

17 C. Waste compaction operations:  N/A 

18 1. Airborne releases evaluated and controlled 

19 [20.1501, 20.1701, L/C]  Yes  No 

20 2. Internal exposures evaluated and controlled 

21 [20.1201, 20.1501, 20.1204, 20.1702, 20.1703]  Yes  No 

22 3. Compliance with 20.1301 evaluated [20.1302]  Yes  No 

23 D. Waste storage areas:  N/A 

24 1. Adequate protection from the elements (floods, 

25 tornadoes, hurricanes, etc.) and fire [L/C]  Yes  No 

26 2. Adequate control of waste in storage [20.1801]  Yes  No 

27 3. Containers properly labeled and area properly 

28 posted [20.1902, 20.1904]  Yes  No 

29 4. Package integrity adequately maintained [L/C]  Yes  No 

30 5. Adequate records of surveys and material 

31 accountability maintained [20.2103, 20.2108]  Yes  No 

32 16. NOTIFICATION AND REPORTS  N/A 

33 A. Licensee in compliance with [19.13, 70.50] (reports to 

34 individuals, public and occupational, monitored to show 

35 compliance with Part 20)  Yes  No  N/A 
E–14 

1 B. Licensee in compliance with [20.2201, 70.50] (theft or loss)  Yes  No  None 

2 C. Licensee in compliance with [20.2202, 70.50] (incidents)  Yes  No  None 

3 D. Licensee in compliance with [20.2203, 70.50] 

4 (overexposures and high radiation levels)  Yes  No  None 

5 E. Licensee aware of telephone number for NRC Emergency 

6 Operations Center [301–816–5100]  Yes  No 

7 17. POSTING AND LABELING 

8 A. NRC Form 3 “Notice to Workers” is posted [19.11]  Yes  No 

9 B. Parts 19, 20, 21, Section 206 of Energy Reorganization Act, 

10 procedures adopted pursuant to Part 21, and license 

11 documents are posted, or a notice indicating where 

12 documents can be examined is posted [19.11, 21.6]  Yes  No 

13 C. Other posting and labeling per [20.1902, 20.1904] and the 

14 license is not exempted by [20.1903, 20.1905]  Yes  No 

15 Remarks: 

16 18. RECORDKEEPING FOR DECOMMISSIONING 

17 A. Records of information important to the safe and effective 

18 decommissioning of the facility maintained in an 

19 independent and identifiable location until 

20 license termination  Yes  No 

21 B. Records include all information outlined in [70.25(g)]  Yes  No 

22 Remarks: 

23 19. NRC CORRESPONDENCE 

24 A. Receipt of NRC Regulatory Issue Summaries, Bulletins, 

25 Information Notices, NMSS newsletters, etc.  Yes  No 

26 B. Appropriate action taken in response to 

27 NRC Correspondence  Yes  No 

28 Remarks: 

29 20. SPECIAL LICENSE CONDITIONS OR ISSUES  N/A 

30 A. Review special license conditions, NRC/Agreement 

31 State violations, Orders, Confirmatory Action Letters, 

32 or other safety or security issues, and describe findings: 

33 B. Problems/deficiencies identified at licensee facilities other than at audit location: 
E–15 

1 C. Evaluation of compliance: 

2 21. CONTINUATION OF REPORT ITEMS  N/A 

3 (If more space is needed, use separate sheets 

4 and attach to report.) 

5 22. PROBLEMS OR DEFICIENCIES NOTED; 

6 RECOMMENDATIONS  N/A 

7 Note: Briefly state (a) the requirement and (b) how and when violated. 

8 Provide corrective actions or recommendations for improvement and 

9 preventive measures 

10 Implemented to prevent recurrence. 

11 23. EVALUATION OF OTHER FACTORS 

12 A. Senior licensee management is appropriately involved 

13 with the radiation safety program and/or RSO oversight  Yes  No 

14 B. RSO has sufficient time to perform his/her radiation 

15 safety duties and is not too busy with other assignments  Yes  No 

16 C. Licensee has sufficient staff  Yes  No 

17 D. Performance-based review 

18 (observation of licensed activities conducted)  Yes  No 

19 Remarks/recommendations: 

20 24. SECURITY OF RADIOACTIVE MATERIALS 

21 [10 CFR PART 37]  N/A 

22 A. Background investigations and access control program 

23 [10 CFR Part 37, Subpart B]  Yes  No 

24 B. Physical protection requirements during use 

25 [10 CFR Part 37, Subpart C]  Yes  No 

26 C. Physical protection in transit 

27 [10 CFR Part 37, Subpart D]  Yes  No 

28 D. Records [10 CFR Part 37, Subpart F]  Yes  No 

29 E. Security of special nuclear material of low strategic 

30 significance [73.67]  N/A 

31 1. Physical protection requirements at fixed sites [73.67(f)]  Yes  No 

32 2. Physical protection requirements in transit [73.67(g)]  Yes  No 
E–16 

1 25. PERFORMANCE-BASED REVIEW  N/A 

2 A. Conduct performance-based reviews of radiation workers 

3 performing licensed activities: 

4 1. to assess the capability of the radiation workers to maintain exposures ALARA; 

5 2. to assess that radiation workers follow the operating procedures; 

6 3. to assess the effectiveness of the operating procedures and compliance with the 

7 regulations, license conditions and the licensee commitments submitted in 

8 support of a license (and incorporated by “tie-down” conditions); 

9 4. to ensure the safe and secure use of radioactive material; 

10 5. to verify that radiation workers are cognizant of the emergency procedures and, if 

11 necessary, would be able to implement them and maintain exposures ALARA; 

12 and 

13 6. to ensure that emergency procedures have been developed for all likely 

14 scenarios. 

15 B. Take the necessary actions to address programmatic and performance 

16 deficiencies with radiation workers and facilitate immediate corrective actions. 
1 APPENDIX F 

2 MODEL RADIATION SURVEY INSTRUMENT CALIBRATION PROGRAM

F–1 

1 Model Radiation Survey Instrument Calibration Program 

2 The specifications in Table F–1 will help applicants and licensees choose the proper radiation 

3 detection equipment for monitoring the radiological conditions at their facility(ies). Additional 

4 information about instruments and their uses also can be found in NUREG–1575, “Multi Agency 

5 Radiation Survey and Sited Investigation Manual (MARSSIM),” Chapter 6 and Appendix H. 

Table F–1. Typical Survey Instruments1. 

 (Instruments used to measure radiological conditions at licensed facilities.) 

Portable Instruments Used for Contamination and Ambient Radiation Surveys 

Detectors Radiation Energy Range Efficiency 

Exposure Rate Meters Gamma, 

X-ray 

μR-R N/A 

Count Rate Meters

GM Alpha All energies 

(dependent on window thickness) 

Moderate 

Beta All energies 

(dependent on window thickness) 

Moderate 

Gamma All energies <1% 

Remball detector Neutron All energies 

(dependent on size of the ball) 

High-purity Germanium 

detector

Gamma All energies High 

NaI Scintillator Gamma All energies 

(dependent on crystal thickness) 

Moderate 

ZnS Alpha All energies Moderate 

Plastic Scintillator Beta C-14 or higher 

(dependent on window thickness) 

Moderate 

Liquid Scintillation 

Counting* 

Alpha All energies High 

Beta All energies High 

Gamma All energies Moderate 

NaI detector* Gamma All energies High 

High-purity Germanium 

detector 

Gamma All energies High 

Gas Proportional Alpha All energies High 
F–2 

Table F–1. Typical Survey Instruments1. (Continued) 

 (Instruments used to measure radiological conditions at licensed facilities.) 

Portable Instruments Used for Contamination and Ambient Radiation Surveys

Detectors Radiation Energy Range Efficiency

Count Rate Meters

Beta All energies Moderate 

Gamma All energies < 1% 

1

“The Health Physics & Radiological Health Handbook.” 4th ed. Thomas E. Johnson and Brian K. Birky, eds. 

 dated 2012. 

*(except for * items).

1 In addition to selecting an instrument that is appropriate for the radiation(s) of interest, it is 

2 important to know if the instrument is sufficiently sensitive so as to make measurements at the 

3 required level. This is particularly important for measurements such as for leak test samples, 

4 bioassay measurement, and decommissioning of facilities or equipment. The “minimum 

5 detectable activity” (MDA) for your instrument should be a fraction (10 to 50 percent) of the 

6 criteria you must meet. 
F–3 

1 Model Radiation Survey Instrument Calibration Program 

2 Training 

3 Before independently calibrating radiation survey instruments, an individual should complete 

4 both classroom and on-the-job training as follows: 

5  Classroom training may be in the form of lecture, video, computer-based, or self-study 

6 and will cover the following subject areas: 

7 — principles and practices of radiation protection 

8 — radioactivity measurements, monitoring techniques, and the use of radiation 

9 detection instruments 

10 — mathematics related to the use and measurement of radioactivity 

11 — biological effects of radiation 

12  On-the-job training will consist of the following: 

13 — observing authorized personnel performing radiation survey 

14 instrument calibration 

15 — conducting radiation survey meter calibrations under the supervision and in the 

16 physical presence of an individual authorized to perform calibrations 

17 Facilities and Equipment for Calibration of Dose and Dose Rate Measuring Instruments 

18  Individuals conducting radiation survey instrument calibrations will wear assigned 

19 dosimetry. 

20  Individuals conducting calibrations will use a calibrated and operable radiation survey 

21 instrument to ensure that unexpected changes in exposure rates are identified and 

22 corrected. 

23  To reduce doses received by individuals not calibrating radiation survey instruments, 

24 calibrations will be conducted in an isolated area of the facility or at times when no one 

25 else is present. 

26  The calibration source should be well collimated, and the calibration area should be 

27 designed to minimize scatter of radiation, which could affect the calibration process. 

28  The calibration area should be appropriately controlled so that persons entering the area 

29 will be aware if a radiation source is in use. Posting as a radiation area also may be 

30 required. 

31 Frequency of Calibration of Radiation Measurement Instruments and Equipment 

32 A licensee committed to a routine or emergency radiation survey program should perform an 

33 acceptable calibration of all radiation measurement instruments and equipment at the frequency 
F–4 

1 specified in U.S. Nuclear Regulatory Commission (NRC) regulations, annually, or at the 

2 frequency recommended by the manufacturer, whichever period is shorter. 

3 Special calibrations should be performed at any time there is reason to believe that the 

4 operating characteristics of a radiation measurement instrument have changed, by repair or 

5 alteration, or whenever system performance is observed to change significantly. 

6 Routine maintenance of radiation measurement instruments should be performed as 

7 recommended by the manufacturer. 

8 Primary or secondary standard instruments used to calibrate radiation measurement 

9 instruments should be inspected frequently for consistency of performance. 

10 Calibration Sources for Dose and Dose Rate Measuring Instruments 

11 A radioactive sealed source(s) will be used for calibrating dose and dose rate measuring 

12 radiation survey instruments, and this source will have the following characteristics: 

13  The source should approximate a point source. 

14  Calibration fields from gamma sources should be known with an accuracy when 

15 compared to secondary or primary national standards of 5 percent for dose rates greater 

16 than or equal to 1.0 microgray/hour (μGy/h) [0.1 millirad/hour (mrad/h)] and 10 percent 

17 for dose rates less than 1.0 μGy/h [0.1 mrad/h]. 

18  The source should contain a radionuclide that emits radiation of identical or similar type 

19 and energy as the environment in which the calibrated device will be used. 

20  The source should be strong enough to give an exposure rate of at least 

21 7.7 microcoulomb per kilogram per hour [30 milliroentgen per hour] at 100 centimeters 

22 {e.g., 3.1 gigabecquerels [(85 mCi (millicuries)] of cesium-137 or 780 megabecquerels 

23 [21 mCi] of cobalt-60}. 

24 Note: Inverse square and radioactive decay laws should be used to correct changes in 

25 exposure rate due to changes in distance or source decay. 

26 Calibration of Dose or Dose Rate Measuring Instruments 

27 There are three kinds of scales frequently used on dose and dose-rate survey meters. These 

28 are calibrated as follows: 

29  Linear readout instruments with a single calibration control for all scales should be 

30 adjusted at the point recommended by the manufacturer or at a point within the normal 

31 range of use. Instruments with calibration controls for each scale should be adjusted on 

32 each scale. After adjustment, check the response of the instrument at approximately 20 

33 percent and 80 percent of full scale. Instrument readings should be within ±x of the 

34 conventionally true value for the following ranges: 

35 — Background to 10 μGy/h [1.0 mrad/h]; ±x = ±30% 

36 — 10 μGy/h [1.0 mrad/h] to 1.0 mGy/h [100 mrad/h]; ±x = ±20% 
F–5 

1 — mGy/h [100 mrad/h] to 10 Gray/h [1,000 Rad/h]; ±x = ±10% 

2  Logarithmic readout instruments, which commonly have a single readout scale 

3 spanning several decades, normally have two or more adjustments. Adjust the 

4 instrument for each scale according to site specifications or the manufacturer’s 

5 specifications. After adjustment, check the calibration at a minimum of one point on 

6 each decade. Instrument readings should have a maximum deviation from the 

7 conventionally true value as described for linear readout instruments. 

8  Digital readout instruments should be calibrated the same as linear 

9 readout instruments. 

Note: Readings above 2.58 × 10-4 10 coulomb/kilogram/hour [1 roentgen/h] need not be 

11 calibrated, unless the licensee expects to make measurements at higher dose rates; regardless, 

12 such scales should be checked for operation and response to radiation. 

13 Calibration of Surface Contamination Measurement Instruments 

14 Instruments used to detect surface contamination usually consist of a count-rate meter and a 

15 detector that is appropriate for the type of radiation(s) being measured. 

16 The efficiency of radiation survey meters must be determined by using radiation sources with 

17 similar energies and types of radiation that users of the radiation survey instrument intend to 

18 measure. 

19 If each scale has a calibration potentiometer, the reading should be adjusted to respond to the 

20 calibration source at approximately 80 percent of full scale, and the response at approximately 

21 20 percent of full scale should be observed. If only one calibration potentiometer is available, 

22 the response should be adjusted at mid-scale on one of the scales, and response on the other 

23 scales should be observed. The instrument efficiency factor (e.g., cpm/dpm) thus obtained 

24 should have a signal-to-noise ratio, including the compilation of source and instrument 

25 uncertainties, of ±x for the following ranges: 

26  alpha measurement 

27 0.01 Bq/cm2 to 2.0 Bq/cm2 [60 to 12,000 dpm/100 cm2]; ±x = ±20% 

28 2.0 Bq/cm2 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2]; ±x = ±10% 

29  beta measurement 

30 0.05 Bq/cm2 to 2.0 Bq/cm2 [300 to 12,000 dpm/100 cm2]; ±x = ±20% 

 2.0 Bq/cm2

 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2 31 ]; ±x = ±10% 
F–6 

1 Model Procedures for Calibrating, Liquid Scintillation Counters, Gamma 

2 Counters, Gas Flow Proportional Counters, and Multichannel Analyzers 

3 Analytical instruments used to determine radioactivity in a sample may be specialized 

4 equipment according to the type of samples to be analyzed and the types and quantities of 

5 radioactivity to be measured. Typically, the sample sizes and activities are very small, and can 

6 be difficult to measure. Sample collection and preparation may differ for the various analytical 

7 instruments, so manufacturer procedures and industry standard practices should be followed. 

8 Such analytical instruments should be calibrated in accordance with the manufacturer’s 

9 instructions. Analytical instruments typically require routine maintenance and verification 

10 procedures to ensure that they are operating properly when used. 

11 As with calibration of other radiation measurement instruments, calibration of analytical 

12 instruments use a radioactive sealed source(s). These should be suitable for the geometry of 

13 the sample(s) to be analyzed. The calibration source(s) should have a known activity(ies) and 

14 be of similar type and energy as the radioactive materials to be analyzed. The analysis should 

15 be sensitive enough to detect the lowest levels of radioactivity desired. Correction of results for 

16 quenching, self-absorption, and other factors may be required, depending on the analytical 

17 instrument, the samples type, and other environmental conditions. 

18 Calibration Records 

19 Calibration records for all radiation survey instruments should indicate the procedure used and 

20 the results of the calibration. The records should include the following: 

21  the owner or user of the radiation survey instrument 

22  a description of the radiation survey instrument, including the manufacturer’s name, 

23 model number, serial number, and type of detector 

24  a description of the calibration source, including the exposure rate at a specified 

25 distance or activity on a specified date 

26  for each calibration point, the calculated exposure rate or count rate, the indicated 

27 exposure rate or count rate, the deduced correction factor (the calculated exposure rate 

28 or count rate divided by the indicated exposure rate or count rate), and the scale 

29 selected on the instrument 

30  the exposure reading indicated with the radiation survey instrument in the “battery 

31 check” mode (if available on the instrument) 

32  for radiation survey instruments with external detectors, the angle between the radiation 

33 flux field and the detector (i.e., parallel or perpendicular) 

34  for radiation survey instruments with internal detectors, the angle between radiation flux 

35 field and a specified surface of the instrument 

36  for radiation detectors with removable shielding, an indication whether the shielding was 

37 in place or removed during the calibration procedure 

38  the exposure rate or count rate from a check source, if used 
F–7 

1  the name and signature of the individual who performed the calibration and the date on 

2 which the calibration was performed 

3 The following information will be attached to the radiation survey instrument as a calibration 

4 sticker or tag: 

5  for dose and dose rate measuring instruments, the source radionuclide used to calibrate 

6 the radiation survey instrument (with correction factors) for each scale 

7  for surface contamination measurement instruments, the efficiency of the radiation 

8 survey instrument, for each radionuclide the instrument will be used to measure 

9 (if efficiency is not calculated before each use) 

10  for each scale or decade not calibrated, an indication that the scale or decade was 

11 checked only for function but not calibrated 

12  the date of calibration and the next calibration due date 

13  the apparent exposure rate or count rate from the check source, if used 

14 Air Sampler Calibration 

15 To assess accurately the air concentration of radioactive materials in a given location, the 

16 volume of air sampled and the quantity of contaminant in the sample must be determined. 

17 Accurate determination of the volume of air sampled requires standard, reproducible, and 

18 periodic calibration of the air metering devices that are used with air sampling instruments. 

19 Licensees can find guidance on total air sample volume calibration methods acceptable to NRC 

20 staff in the publication titled “Air Sampling Instruments,” which can be found in the 9th Edition, 

21 American Conference of Governmental Industrial Hygienists, 2001. This information is 

22 supplemented below. 

23 Frequency of Calibration of Air Sampling Equipment 

24  A licensee committed to a routine or emergency air sampling program should perform an 

25 acceptable calibration of all airflow or volume metering devices at least annually 

26 (See Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace”). 

27  Special calibrations should be performed at any time there is reason to believe that the 

28 operating characteristics of a metering device have been changed, by repair or 

29 alteration, or whenever system performance is observed to have changed significantly. 

30  Routine instrument maintenance should be performed as recommended by 

31 the manufacturer. 

32  Primary or secondary standard instruments used to calibrate air sampling instruments 

33 should be inspected frequently for consistency of performance. 
F–8 

1 Error Limit For Measurement of Air Sample Volume 

2 Most methods of calibrating airflow or air volume metering devices require direct comparison to 

3 a primary or secondary standard instrument to determine a calibration curve or a correction 

4 factor. An example of a primary standard is a spirometer that measures total air volume directly 

5 with high precision by liquid displacement. An example of a secondary standard is a wet-test 

6 meter that has been calibrated against a primary standard. 

7 The following are significant errors associated with determining the total air volume sampled: 

8 EC: The error in determining the calibration factor. (An acceptable estimate is the 

percentage error associated with the standard instrument used in the calibration.)1 9 

10 ES: Intrinsic error in reading the meter scale. (An acceptable estimate is the percentage 

11 equivalent of one-half of the smallest scale division, compared to the scale reading.) 

12 Et: The percentage error in measurement of sampling time that should be kept within 

13 1 percent. 

14 EV: The most probable value of the cumulative percentage error in the determination of the 

15 total air volume sampled. EV can be calculated from the following equation, provided 

16 there are no additional significant sources of errors: 

EV = [ES

2

 + EC

2

 + Et

2

]

1/2 17 

18 The most probable value of the cumulative error EV, in the determination of total volume, should 

19 be less than 20 percent. 

20 A sample calculation of the most probable value of the cumulative error in total volume 

21 measured is as follows: If accuracies of the scale reading, the calibration factor, and sample 

22 time are ± 4, 2, and 1 percent, respectively, and there are no other significant sources of error, 

23 the cumulative error would be: 

EV = [42

 + 22 + 12]

1/2 24 = 4.58 percent or approx. 5 percent 

25 If there are significant differences in pressure and temperature between the calibration site 

26 and the sampling site, appropriate corrections should be made using the ideal gas laws 

27 provided below: 

28 Vs = V1 * (P1/760) * (273/T1) 

29 where Vs = volume at standard pressure and temperature (760 mm Hg and 273° K) 

30 V1 = volume measured at conditions P1 and T1

 

1

The calibration factor should be based on two kinds of determinations. First, correction factors should be 

determined at several flow rates distributed over the full-scale range. Each flow rate correction factor should be 

determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets of 

data should be compared. Second, subsequent calibrations should compare the new correction factors to those 

determined during the previous calibration. If observed differences are significant compared to the overall volume 

error limit of 20 percent, an additional error term should be included in the calculation above. 
F–9 

1 T1 = temperature of V1 in K 

2 P1 = pressure of V1 in mm Hg 

3 Documentation of Calibration of Air Metering Devices 

4 The licensee should maintain records of all routine and special calibrations of airflow or volume 

5 metering devices, including the primary or secondary standard used, method employed, and 

6 estimates of accuracy of the calibrated metering devices. All instruments should be clearly 

7 labeled as to the date and results of the most recent calibration and should include the 

8 appropriate correction factors to be used. 

9 References: See the Notice of Availability on the inside front cover of this report to obtain a 

10 copy of: 

11  Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” June 1992. 

12  NUREG–1400, “Air Sampling in the Workplace,” September 1993 

13 (ADAMS Accession No. ML13051A671). 

14  The Health Physics & Radiological Health Handbook, 4th Edition, Edited by 

15 Thomas E. Johnson and Brian K. Birky, 2012. 

16  American National Standards Institute (ANSI) N323AB-2013, “American National 

17 Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey 

18 Instruments.” Copies may be obtained from the American National Standards Institute 

19 (ANSI) at www.ansi.org. 

20  “Air Sampling Instruments,” American Conference of Governmental Industrial Hygienists, 

21 9th Edition, 2001. 

1 APPENDIX G 

2 GUIDANCE FOR DEMONSTRATING THAT UNMONITORED INDIVIDUALS 

3 ARE NOT LIKELY TO EXCEED 10 PERCENT OF THE ALLOWABLE LIMITS

G–1 

1 Guidance for Demonstrating that Unmonitored Individuals are Not Likely to 

2 Exceed 10 Percent of the Allowable Limits 

3 Dosimetry is required for individual adults likely to receive, in 1 year from sources external to the 

4 body, an occupational dose in excess of 10 percent of the applicable regulatory limits in 

5 Title 10 of the Code of Federal Regulations (10 CFR) 20.1201. To demonstrate that dosimetry 

6 is not required, a licensee needs to perform a prospective evaluation to demonstrate that its 

7 adult workers are not likely to exceed 10 percent of the applicable limits. 

8 The most common way that individuals might exceed 10 percent of the applicable limits is by 

9 being involved in the processing of sealed sources and/or unsealed material, (e.g., assembly 

10 lines, manufacturing processes and quality control activities). This could include internal 

11 radioactive uptake, as well as external radiation exposure. However, for many processes, even 

12 these activities result in the individual receiving minimal doses. Before allowing workers to 

13 perform these tasks, a licensee will need to evaluate the doses that its workers might receive to 

14 assess whether dosimetry is required. This is known as a prospective evaluation. 

15 Example 

16 One university has estimated the doses to the extremities and whole body of a person 

17 conducting foil activation experiments using Pu-238/beryllium (Be) sources. Each Pu-238/Be 

18 source is authorized to contain up to 200 grams of plutonium. The university based its estimate 

19 on observations of individuals performing the recommended procedure according to accepted 

20 radiation safety practices. The university had the following types of information: 

21  Time needed to perform the entire procedure (e.g., 15 minutes) 

22  Expected dose rate received by the whole body of the individual, associated with the 

23 shielded source, and determined using measured or manufacturer-determined data 

24 {e.g., 0.02 mSv/hr [2 mrem/hr] at 46 cm [18.1 in] from the shield} 

25  Time the hands were exposed to the shielded source (e.g., 6 min) 

26  Expected dose rate received by the extremities of the individual, associated with the 

27 shielded source and determined using measured or manufacturer-determined data on 

28 contact with the shield {e.g., 0.15 mSv/hr [15 mrem/hr]} 

29 From this information, the university estimated that the individual performing each foil activation 

30 experiment could receive the following: 

31  Less than 0.005 mSv [0.5 mrem] total effective dose equivalent (TEDE) 

32 (whole body) and 

33  0.015 mSv [1.5 mrem] to the hands 

34 The applicable TEDE (whole body) limit is 50 mSv [5 rem] per year and 10 percent of that value 

35 is 5 mSv [500 millirem] per year. If one of these procedures delivers 0.005 mSv [0.5 mrem], 

36 then an individual could perform 1,000 of these experiments each year and remain within 

37 10 percent of the applicable limit. 
G–2 

1 The applicable SDE (extremities) is 500 mSv [50 rem] per year and 10 percent of that value is 

2 50 mSv [5 rem or 5000 millirem] per year. If one of these experiments delivers 0.015 mSv 

3 [1.5 mrem], then an individual could perform 3,333 of these procedures each year and remain 

4 within 10 percent of the applicable limit. 

5 Based on the above specific situation, no dosimetry is required if an individual performs fewer 

6 than 1,000 foil activation experiments per year. 

7 Guidance to Licensees 

8 Licensees who wish to demonstrate that they are not required to provide dosimetry to their 

9 workers need to perform prospective evaluations similar to the example provided above. The 

10 expected dose rates, times, and distances used in the above example may not be appropriate 

11 to all licensees. In their evaluations, licensees need to use information appropriate to the 

12 type(s) of processes they intend to use. 

13 Table G–1 may be helpful in performing a prospective evaluation and provides an example of 

14 the documentation to show that unmonitored individuals will not exceed 10 percent of the 

15 allowable dose limits. 

16 Licensees should review evaluations periodically and revise them, as needed. Licensees need 

17 to check assumptions used in their evaluations to ensure that they are up-to-date and accurate. 

18 For example, if workers become lax in following good radiation safety practices, perform the 

19 task more slowly than estimated, utilize a new sealed source containing sources of different 

20 activities or radionuclides, or use modified procedures, the licensee would need to conduct a 

21 new evaluation. 

Table G–1. Dosimetry Evaluation 

Dosimetry Evaluation for ___________________ 

A. Time needed to perform the entire 

work activity 

_________ minutes _________ hour 

(divide # of 

minutes by 60) 

B. Expected whole body dose rate that the 

individual will encounter, determined using 

measured or manufacturer-provided data 

____________ millirem/hour

C. Time the extremities were exposed to the 

unshielded source (if applicable) 

_________ minutes _________ hour 

D. Expected extremity dose rate that the 

individual will encounter, determined using 

measured or manufacturer-provided data for 

the unshielded source at the typical distance 

from the hands to the unshielded source 

____________ millirem/hour

Estimated Whole Body Dose Equivalent* 

Formula: (_____hours in Row A) × (______millirem/hour in Row B) = (_____estimated millirem) 

× (_____# times conducted each year) = _______ millirem 

Estimated Extremity Dose Equivalent†

Formula: (_____hours in Row C) × (______millirem/hour in Row D) = (_____estimated 

millirem) × (_____# of times conducted each year) = _______ millirem 

*An expected Whole Body Dose Equivalent less than 500 millirem requires no dosimetry. †

An expected Extremity Dose Equivalent less than 5,000 millirem requires no dosimetry.
1 APPENDIX H 

2 PUBLIC DOSE 

H–1 

1 Public Dose 

2 This appendix describes methods for determining radiation doses to members of the public. 

3 Licensees must ensure that: 

4  The radiation dose received by individual members of the public does not exceed 

5 1 millisievert (mSv) [100 millirem (mrem)] in 1 calendar year resulting from the licensee’s 

6 possession and/or use of licensed materials. 

7  The radiation dose in unrestricted areas does not exceed 0.02 mSv [2 mrem] in any 

8 one hour. 

9  Air emissions of radioactive materials do not result in doses greater than 0.1 mSv 

10 [10 mrem] per year total effective dose equivalent (TEDE). As required by Title 10 of the 

11 Code of Federal Regulations (10 CFR) 20.1101(d), if the licensee exceeds the 10 mrem 

12 per year air emission dose constraint, the licensee must report the exceedance as 

13 provided in 10 CFR 20.2203, and promptly take appropriate corrective action to ensure 

14 against recurrence. 

Members of the public include persons who live, work, study, or may be near locations where 

licensed material is used or stored, and employees whose assigned duties do not include the 

use of licensed material but may work in the vicinity where such materials are used or stored. 

Doses to Members of the Public 

INCLUDE doses from 

 radiation and/or radioactive material 

released by a licensee 

 sources of radiation under the control of a 

licensee 

 effluents from sources of licensed 

radioactive materials 

 licensed material in transportation or 

storage at the licensee’s facility 

DO NOT INCLUDE doses from 

 sanitary sewerage discharges from licensee 

action taken in accordance with 

10 CFR 20.2003 

 natural background radiation 

 medical administration of radioactive material 

including patients released under 

10 CFR 35.75 

 voluntary participation in medical research 
H–2 

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. 

1 The licensee may show compliance with the annual dose limit for individual members of the 

2 public by: 

3  demonstrating by measurement or calculation that the TEDE to the individual likely to 

4 receive the highest dose at the boundary of the unrestricted area does not exceed 

5 1 mSv [100 mrem] in a year 

6  demonstrating that the annual average concentration of radioactive material released 

7 in gaseous and liquid effluents at the boundary of the unrestricted area does not 

8 exceed the values specified in Table 2, “Effluent Concentrations,” of Appendix B, to 

9 10 CFR Part 20. {The licensee also should show that if an individual were continuously 

10 present in an unrestricted area, the dose from external sources would not exceed 

11 0.02 mSv [2 mrem] in any one hour and 0.5 mSv [0.05 rem] in a year.} 

12 To perform a dose assessment, the licensee should identify all potential sources of external and 

13 internal radiation exposure to members of the public and all locations of use, transport, and 

14 storage of radioactive material at the facility. The licensee must then take radiation 

15 measurements or perform calculations to demonstrate compliance. 

16 Measurements 

17 The licensee may use measurements to demonstrate that the average annual releases are 

18 within regulatory limits, as well as demonstrate that the TEDE to the individual likely to receive 

19 the highest dose at the boundary of the unrestricted area does not exceed 1 mSv [100 mrem] in 

20 a year. These measurements may include 

21  dose rate surveys for radiation exposures from external radiation sources 

22  measurements of radionuclides in air and water effluent 

23 The method used to measure dose will depend on the nature of the radiation source. If the 

24 source of radiation is constant, it may be adequate to measure the dose rate and integrate it 

25 over time. If the source of radiation differs or changes over time, it may be necessary to 

26 perform continuous measurements. 

27 Radioactivity releases may be determined by effluent monitoring or by effluent sampling and 

28 analysis. Airborne effluents may be discharged when volatile materials are used, such as 

29 during iodinations, but the discharge itself usually is not continuous since volatile materials often 

30 are used periodically rather than continuously. Liquid effluents may be discharged continuously 
H–3 

1 or may be stored and subsequently discharged on a batch basis. For each type of source and 

2 for each route of potential exposure, consider the location of measurement points, whether 

3 continuous or periodic monitoring is required, the frequency of sampling and measurement, and 

4 any additional information. For discharges of airborne radionuclides, for example, it may be 

5 necessary to obtain information on the efficiency of filters and the air flow rate of the discharge 

6 system, as well as meteorological data and the distance to the nearest individual member of 

7 the public. 

8 Calculation Method 

9 Using a calculation method, the licensee must determine the highest dose an individual is likely 

10 to receive at the boundary of the unrestricted area. The licensee must take into account the 

11 individual’s exposure from external sources and the concentration of radionuclides in gaseous 

12 and liquid releases. In practice, the licensee may wish to make conservative assumptions to 

13 simplify the dose calculation. 

14 The public dose limit applies to the individual who is likely to receive the highest dose from 

15 licensed operations. Therefore, the dose calculations must consider the location with the 

16 potential for the highest internal and external exposures. An extremely conservative calculation 

17 would assume that the individual was continuously present 24 hours a day, 365 days a year, or 

18 an occupancy factor of 1 (see Table H–1). If the result of the calculation using an occupancy 

19 factor of 1 demonstrates that the public dose limit is not exceeded, then there is no need for 

20 further evaluation. 

21 If, however, the licensee would rather choose a more realistic assumption of the individual’s 

22 occupancy at the points of highest internal and external exposures, then the licensee may use 

23 the occupancy factors in Table H–1 or may calculate a specific occupancy factor by determining 

24 the likely fraction of time that the individual is present. 

Table H–1. Standard Occupancy Factors 

Occupancy Factor Description 

1 Work areas such as offices, laboratories, shops, and occupied space in 

nearby buildings or outdoor areas 

1⁄4 Corridors, lounges, elevators using operators, unattended parking lots 

1/16 Waiting rooms, restrooms, stairways, unattended elevators, janitor’s 

closets, outside areas used only for pedestrians or vehicular traffic 

25 Records 

26 In accordance with 10 CFR 20.2107, the licensee must maintain records to demonstrate 

27 compliance with the dose limit for individual members of the public, until the Commission 

28 terminates the license. In general, survey and monitoring records of ambient radiation and 

29 effluent radioactivity should be adequate. 

30 Records demonstrating the dose to an individual member of the public should identify the 

31 instruments used in the survey, the name of the surveyor, the date of the survey, the location of 

32 the survey(s) including a description or drawing of the area surveyed, survey results, and if 
H–4 

1 applicable, the occupancy factors used and justification for their use. In addition, records 

2 demonstrating the dose to an individual member of the public that involve effluent sampling 

3 analysis should include information on concentrations of specific radionuclides, minimum 

4 detectable activity of the system, and the estimated uncertainty of measurements. 
1 APPENDIX I 

2 RADIATION SAFETY SURVEY TOPICS

I–1 

1 Radiation Safety Survey Topics 

2 This appendix provides applicants and licensees with additional information on surveys, 

3 including training requirements, survey frequency, contamination limits, and bioassays. 

4 Training 

5 Before independently performing radiation surveys, an individual should complete both 

6 classroom and on-the-job training as follows: 

7  Classroom training may be in the form of lecture, video, computer-based, or self-study 

8 and will cover the following subject areas: 

9 — principles and practices of radiation protection 

10 — radioactivity measurements, monitoring techniques, and using instruments 

11 — usage and basic mathematics and calculations for measuring radioactivity 

12 — biological effects of radiation 

13  Appropriate on-the-job-training consists of the following: 

14 — observing authorized personnel using survey equipment, collecting samples, and 

15 analyzing samples 

16 — using survey equipment, collecting samples, and analyzing samples under the 

17 supervision and in the physical presence of an individual authorized to perform 

18 surveys 

19 Facilities and Equipment 

20  To ensure achieving the required sensitivity of measurements, survey samples will be 

21 analyzed in a low-background area. 

22  A gamma counter system with a single or multichannel analyzer can be used to count 

23 samples containing gamma-emitters (e.g., iodine-125, cesium-137, cobalt-60). 

24  A liquid scintillation counting (LSC) system can be used to count samples containing 

25 most beta-emitters and gamma-emitters (if efficiency is great enough to achieve the 

26 required sensitivity for measurements). The LSC is the most common instrument used 

27 for measurement of tritium (H-3) contamination and other low-energy beta-emitters 

28 commonly used in laboratory research and development, such as carbon-14, sulfur-35, 

29 and phosphorus-32. 

30  Licensees may use a gas-flow proportional counting system to count samples containing 

31 alpha-emitters, beta-emitters, and gamma-emitters (if efficiency is great enough to 

32 achieve the required sensitivity for measurements). 
I–2 

1 Ambient Radiation Level Surveys 

2  Dose-rate surveys, at a minimum, should be performed in locations where workers are 

3 exposed to radiation levels that might result in radiation doses in excess of 10 percent of 

4 the occupational dose limits or where an individual is working in a dose rate of 

5 0.025 millisievert (mSv) [2.5 millirem/hour (mrem/h)] or more (50 mSv/year divided by 

6 2,000 h/year). 

7  10 CFR 20.1301 requires that the TEDE to an individual member of the public from the 

8 licensed operation does not exceed 1 mSv [0.1 rem] in a year and the dose in any 

9 unrestricted area from external sources does not exceed 0.02 mSv [2 mrem] in any 

10 one hour. 

11 The frequency of ambient surveys depends on the quantity and use of radioactive materials, as 

12 well as the specific protective facilities, equipment, and procedures that are designed to protect 

13 the worker and members of the public from external exposure to radiation. While the 

14 regulations do not specify a specific survey frequency, the licensee must conduct such surveys 

15 as will ensure that the dose rate limits in Title 10 of the Code of Federal Regulations (10 CFR) 

16 Part 20 Subparts C and D are not exceeded. 

17 Contamination Surveys 

18 Licensees’ contamination surveys should be sufficient to identify areas of contamination that 

19 might result in doses to workers or to the public. Combined removable and fixed contamination 

20 should be surveyed using appropriate radiation detection equipment. Removable contamination 

21 can be detected and measured through a wipe test of the surface, which is counted in an 

22 appropriate counting instrument, such as a liquid scintillation counter, a sodium iodide or 

23 germanium gamma counter, or a proportional alpha/beta counter. 

24 Contamination surveys will be performed: 

25  to evaluate radioactive contamination that could be present on surfaces of floors, walls, 

26 laboratory furniture, and equipment 

27  after any spill or contamination event 

28  when procedures or processes have changed 

29  to evaluate contamination of users and the immediate work area, at the end of the day or 

30 before leaving the area of use, when licensed material is used 

31  in unrestricted areas at frequencies consistent with the types and quantities of materials 

32 in use but generally not less frequently than quarterly 

33  in areas adjacent to restricted areas and in all areas through which licensed materials 

34 are transferred and temporarily stored before shipment 

35 Contamination Survey Frequency 

36 Personnel should survey for contamination in locations where individuals are working with an 

37 unsealed form of radioactive material. These surveys should be done at a frequency 
I–3 

1 appropriate to the types and quantities of radioactive materials in use. If the activity used is 

2 greater than or equal to the smallest annual limit on intake (ALI) (for either inhalation or 

3 ingestion), as identified in 10 CFR Part 20, Appendix B, then documented surveys should be 

4 performed at least daily and retain records in accordance with 10 CFR 20.2103. 

5 Table I–1 contains suggested contamination survey frequencies based on ALIs. The suggested 

6 frequency of surveys is based upon the amount of licensed material “in use” at any one time at 

7 any particular location. If licensed material has not been used for a period of time greater than 

8 the required survey frequency, then it is considered to be “not in use.” 

Table I–1. Suggested Contamination Survey Frequency 

< 0.1 ALI ≥ 0.1 ALI < 1.0 ≥ 1.0 ALI 

In Use Monthly Weekly Daily 

Not in Use Every 6 Months 

9 Contamination in Unrestricted Areas 

10 Contamination found in unrestricted areas should be immediately decontaminated to 

11 background levels. When it is not possible to get to background levels, the licensee must 

12 ensure that the amounts do not exceed the contamination levels listed in Table I–2, taken from 

13 the NRC Policy and Guidance Directive FC 83-23, “Guidelines for Decontamination of Facilities 

14 and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, 

15 Source, or Special Nuclear Material” (August 1987) (ADAMS Accession No. ML030590504). 

16 Note that, for the purposes of release of facilities for unrestricted use or termination of the 

17 license, these values have been superseded by 10 CFR Part 20 Subpart E, “Radiological 

18 Criteria for License Termination,” and cannot be used for that purpose. In particular, the 

19 acceptable contamination levels listed below for most alpha emitters exceed the levels which 

20 will meet the 10 CFR Part 20 Subpart E criteria. Table I–2 levels can continue to be used for 

21 release of equipment and material from licensed material facilities during operational activities 

22 prior to license termination. (63 FR 64134; November 18, 1998) 

Table I–2. Acceptable Surface Contamination Levels 

Nuclide1 Average2,3 Maximum2,4 Removable2,5

U-nat, U-235, U-238, 

and associated 

decay products

83.3 Bq/100 cm2

[5,000 dpm/100 cm2]

250 Bq/100 cm2

[15,000 dpm/100 cm2]

16.7 Bq/100 cm2

[1,000 dpm/100 cm2]

Transuranics, Ra-226, 

Ra-228, Th-230, 

Th-228, Pa-231, 

Ac-227, I-125, I-129 

1.7 Bq/100 cm2

[100 dpm/100 cm2

] 

5.0 Bq/100 cm2

[300 dpm/100 cm2

] 

0.3 Bq/100 cm2

[20 dpm/100 cm2

] 

Th-nat, Th-232, Sr-90, 

Ra-223, Ra-224, 

U-232, I-126, I-131, 

I-133 

16.7 Bq/100 cm2

[1,000 dpm/100 cm2] 

50.0 Bq/100 cm2

[3,000 dpm/100 cm2]

3.3 Bq/100 cm2

[200 dpm/100 cm2] 
I–4 

Beta-gamma emitters 

(nuclides with decay 

modes other than 

alpha emission or 

spontaneous 

fission) except Sr-90 

and others noted 

above. 

83.3 Bq/100 cm2

[5,000 dpm/100 cm2

] 

250 Bq/100 cm2

[15,000 dpm/100 cm2

] 

16.7 Bq/100 cm2

[1,000 dpm/100 cm2

] 

1

Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for 

alpha- and beta-gamma-emitting nuclides should apply independently. 

2

As used in this table, disintegrations per minute (dpm) means the rate of emission by radioactive material as 

determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and 

geometric factors associated with the instrumentation. 3

Measurements of average contaminant should not be averaged over more than 1 square meter. For objects of less 

surface area, the average should be derived for each such object. 

4

The maximum contamination level applies to an area of not more than 100 square centimeters (cm2). 5

The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that area 

with a filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material 

on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of less 

surface area is determined, the pertinent levels should be reduced proportionally and the entire surface should 

be wiped. 

1 For equipment that is potentially contaminated and is to be released for unrestricted use, 

2 Table I–2 provides the maximum acceptable residual levels for equipment. Additional guidance 

3 for release of equipment can be found in NUREG–1575, Supplement 1, “Multi-Agency Radiation 

4 Survey and Assessment of Materials and Equipment Manual (MARSAME).” Table I–2 values 

5 also may be acceptable criteria for contamination in facilities during facilities in operation. 

6 A standardized method for smear testing of a relatively uniform area should be used to aid in 

7 comparing contamination at different times and places. A smear taken from an area of about 

100 cm2 8 is acceptable to indicate levels of removable contamination. 

9 Decommissioning Surveys for Release for Unrestricted Use 

10 When a facility will be closed and released for unrestricted use, the values in Table I–3 provide 

11 acceptable residual contamination levels, known as “screening values” for building surfaces. To 

12 the extent practicable, facilities should be decontaminated to below these levels [as low as is 

13 reasonably achievable (ALARA)]. Surveys should be conducted for both removable 

14 contamination (not to exceed 10 percent of the values in Table I–3) and for total residual 

15 contamination before the facilities or equipment are released from restricted to unrestricted use, 

16 to ensure that they meet the applicable limits. 

Table I–3. Screening Values for Building Surface Contamination* 

Radionuclide Symbol Screening levels for unrestricted release (dpm/100 cm2)

Hydrogen-3 (Tritium) H-3 1.2 × 108

Carbon-14 C-14 3.7 × 106

Sodium-22 Na-22 9.5 × 103

Sulfur-35 S-35 1.3 × 107

Chlorine-36 Cl-36 5.0 × 105

Manganese-54 Mn-54 3.2 × 104

Iron-55 Fe-55 4.5 × 106
I–5 

Table I–3. Screening Values for Building Surface Contamination* 

Radionuclide Symbol Screening levels for unrestricted release (dpm/100 cm2)

Cobalt-57 Co-57 2.1 × 105

Cobalt-60 Co-60 7.1 × 103

Nickel-63 Ni-63 1.8 × 106

Zinc-65 Zn-65 4.8 × 104

Strontium-90 Sr-90 8.7 × 103

Technetium-99 Tc-99 1.3 × 106

Iodine-129 I-129 3.5 × 104

Cesium-137 Cs-137 2.8 × 104

Europium-152 Eu-152 1.3 × 104

Tungsten-181 W-181 1.1 × 106

Iridium-192 Ir-192 7.4 × 104

*Screening levels are based on the assumption that the fraction of removable surface contamination is equal to 0.1. 

For cases when the fraction of removable contamination is undetermined or higher than 0.1, users may assume, for 

screening purposes, that 100 percent of surface contamination is removable; and, therefore, the screening levels 

should be decreased by a factor of 10. Alternatively, users having site-specific data on the fraction of removable 

contamination (e.g., within 10 percent to 100 percent range) may calculate site-specific screening levels using the 

DandD, Version 1 computer code. 

Units are disintegrations per minute per 100 cm2

 (dpm/100 cm2 1 ). One dpm is equivalent to 

2 0.0167 Bq. The screening values represent surface concentrations of individual radionuclides 

3 that would be deemed in compliance with the 0.25 mSv [25 mrem] in a year unrestricted release 

4 dose limit in 10 CFR 20.1402, “Radiological criteria for unrestricted use.” For radionuclides in a 

5 mixture, the “sum of fractions” rule applies; see 10 CFR Part 20, Appendix B, Note 4 for an 

6 example of the “sum of fractions” calculation. Refer to NUREG–1757, “Consolidated 

7 Decommissioning Guidance,” for further information on application of the values in this table. 

8 Table I–3 was derived using the screening criteria in the DandD, Version 1, (DandD, v1.0) 

9 computer code and its default input parameters. Table I–3 provides criteria that permit 

10 licensees to demonstrate compliance with the unrestricted release dose criterion in the License 

11 Termination Rule in Subpart E of 10 CFR Part 20. Sites with building surface contamination 

12 levels below those listed in Table I–3 would be deemed acceptable for release for unrestricted 

13 use in accordance with the dose criteria in 10 CFR 20.1402, provided that residual radioactivity 

14 has been reduced to ALARA levels. The table is intended for use as criteria to facilitate license 

15 termination for many simple routine decommissioning cases without a site-specific dose 

16 assessment. For facilities with contamination levels above those in Table I–3, additional 

17 site-specific dose assessments may be necessary, and licensees should refer to NUREG–1757 

18 regarding acceptable methods for conducting the appropriate dose assessment, such as using 

19 the current version of DandD to develop site-specific screening criteria. The most recent 

20 version of the DandD code can be installed by downloading the self-extracting program file, 

21 setup.exe, accessed through the Web site: http://www.marssim.com/Dose_Modeling.htm. 

22 Links to other useful software and guidance documents are also found at that Web site. 

23 Table I–3 does not include screening values for radionuclides that emit alpha particles, or for 

24 soil contamination. Screening values for radionuclides not listed above may be found in 

25 “Supplemental Information on the Implementation of the Final Rule on Radiological Criteria for 

26 License Termination” (63 FR 64132; November 18, 1998) for building surfaces; “Supplemental 

27 Information on the Implementation of the Final Rule on Radiological Criteria for License 

28 Termination” (64 FR 68395; December 7, 1999) for soils; and “Use of Screening Values to 

29 Demonstrate Compliance With the Final Rule on Radiological Criteria for License Termination” 
I–6 

1 (65 FR 37186; June 13, 2000), which references Tables 5-19 (surface contamination) and 6.91 

2 (surface soil) from NUREG/CR–5512, Volume 3, “Residual Radioactive Contamination from 

3 Decommissioning, Parameter Analysis, Draft Report for Comment, October 1999.” Tables 5-19 

4 (surface contamination) and 6.91 (surface soil) are for use in determining acceptable screening 

5 values are for radionuclides not listed in the first two Federal Register notices. 

The type of surveys to be performed for decommissioning of facilities, and the number and 

locations of survey points or samples to be collected, should be determined using guidance 

found in NUREG–1757. Many broad-scope licensees will be able to use the “Simple 

Approaches for Conducting Final Radiological Surveys” found in Appendix B of NUREG–1757, 

Volume 2. If the decommissioning of a facility is too complex to allow use of one of the “simple 

approaches,” then a licensee may have to develop a more formal decommissioning plan. 

6 Survey Record Requirements 

7 Each survey record will include the following: 

8  a diagram of the area surveyed 

9  a list of items and equipment surveyed 

10  specific locations on the survey diagram where wipe test was taken 

11  ambient radiation levels with appropriate units 

12  contamination levels with appropriate units 

13  make and model number of instruments used 

14  background levels 

15  name of the person making the evaluation and recording the results and date 

16 Licensees should record contamination levels observed and procedures followed for incidents 

17 involving contamination of individuals. The record should include names of individuals involved, 

18 description of work activities, calculated dose, probable causes (including root causes), steps 

19 taken to reduce future incidents of contamination, times and dates, and the surveyor’s 

20 signature. In addition, 10 CFR 30.35(g), 40.36(f), and 70.25(g) state, in part, that records of 

21 information important to the decommissioning of a facility, including records of spills or other 

22 unusual occurrences involving the spread of contamination in and around the facility, 

23 equipment, or site, must be maintained. 

24 Air Monitoring in the Workplace 

25 Air monitoring can be used to do the following: 

26  determine whether the confinement of radioactive materials is effective 

27  measure airborne radioactive material concentrations in the workplace 

28  estimate worker intakes of radioactive material 

29  determine posting requirements 

30  determine what protective equipment and measures are appropriate 

31  warn of significantly elevated levels of airborne radioactive materials 

32 If bioassay measurements are used to determine worker doses of record, air sampling may be 

33 used to determine time of intake and to determine which workers should have bioassay 

34 measurements. The use of engineering controls and a good air sampling program can 

35 eliminate the need for bioassays. 
I–7 

1 Refer to Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” dated June 1992, 

2 and NUREG–1400, “Air Sampling in the Workplace,” dated September 1993, which is 

3 available in the NRC Agencywide Documents Access and Management System at Accession 

4 No. ML13051A671, for further guidance on air sampling. 

5 Airborne Effluent Release Monitoring 

6 When practicable, airborne radioactive effluents should be released from monitored release 

7 points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to 

8 estimate public exposure. Licensees should verify the performance of effluent monitoring 

9 systems by regular calibration (at least annually) to ensure their reliability. 

10 Regulatory Guide 4.20, Revision 1, “Constraints on Release of Airborne Radioactive Materials 

11 to the Environment for Licensees Other Than Power Reactors,” dated April 2012, provides 

12 guidance on methods acceptable (calculation or COMPLY code) to NRC for compliance with the 

13 constraint on air emissions to the environment. 

14 Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” dated July 1993, 

15 provides guidance on designing an acceptable program for establishing and maintaining ALARA 

16 levels for gaseous and liquid effluents at materials facilities. 

17 For release points for which monitoring is not practicable, the licensee should estimate the 

18 magnitude of the unmonitored effluents. These unmonitored releases will occur anytime 

19 unsealed material is handled outside a fume hood or other device that will control the releases. 

20 The licensee should include these estimates when demonstrating compliance with dose limits 

21 and ALARA goals. Unmonitored releases may be estimated based on the quantity of material 

22 used in these areas, the number of procedures performed, or other appropriate methods. The 

23 unmonitored effluents should not exceed 30 percent of the total estimated effluent releases or 

24 10 percent of the permissible air effluent concentrations found in column 1 of Table 2 in 10 CFR 

25 Part 20, Appendix B, whichever is greater. 

26 Effluent monitoring systems should be designed in accordance with ANSI N13.1 (2011), 

27 “Sampling And Monitoring Releases Of Airborne Radioactive Substances From The Stacks And 

28 Ducts Of Nuclear Facilities,” and ANSI N42.18 (2004), “Specification and Performance of On29 site Instrumentation for Continuously Monitoring Radioactivity in Effluents.” 

30 Liquid Effluent Release Monitoring 

31 The licensee should evaluate the concentrations of radioactive material in water that is released 

32 to the sanitary sewer and to the environment. The licensee must show that these releases meet 

33 the limits in 10 CFR 20.2003 and 10 CFR 20.1302, respectively. 

34 The topic of sanitary sewerage releases is more fully discussed in 10 CFR Part 20, Appendix B. 

35 Bioassay Monitoring 

36 Frequency of Required Bioassay Measurements 

37 Determining the appropriate frequency of routine bioassay measurements depends upon the 

38 exposure potential and the physical and chemical characteristics of the radioactive material and 

39 the route of entry to the body. Consider the following elements: 
I–8 

1  potential exposure of the individual 

2  retention and excretion characteristics of the radionuclides 

3  sensitivity of the measurement technique 

4  acceptable uncertainty in the estimate of intake and committed dose equivalent 

5 Bioassay measurements used for demonstrating compliance with the occupational dose limits 

6 should be conducted often enough to identify and quantify potential exposures and resultant 

7 intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10 percent 

8 ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes 

9 and assess occupational doses for exposed individuals who are likely to exceed 10 percent of 

10 the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults). 

11 Separate categories of bioassay measurements, routine measurements, and special 

12 measurements further determine the frequency and scope of measurements. 

13 Routine Measurements 

14 Routine measurements include baseline measurements, periodic measurements, and 

15 termination measurements. These measurements should be conducted to confirm that 

16 appropriate controls exist and to assess dose. The method of bioassay selected (for example, 

17 whole body counting, urinalysis) and the samples collected will vary according to the 

18 radionuclides and the compound to which it is attached. Sample collection procedures should 

19 be developed to ensure that appropriate types, sizes, and numbers of samples are collected 

20 that will provide appropriate physiological information for the dose assessment. 

21 An individual’s baseline measurement of radioactive material within the body should be 

22 conducted before beginning work that involves exposure to radiation or radioactive materials for 

23 which monitoring is required. 

24 In addition to the baseline measurements, periodic bioassay measurements should be 

25 performed. The frequency of periodic measurements should be based on the likelihood of 

26 significant exposure of the individual. In determining the worker’s likely exposure, consider such 

27 information as the worker’s access, work practices, measured levels of airborne radioactive 

28 material, and exposure time. Periodic measurements should be made when the cumulative 

29 exposure to airborne radioactivity since the most recent bioassay measurement is > 0.02 ALI 

30 (40 derived air concentration hours). Noble gases and airborne particulates with a radioactive 

31 half-life of less than 2 hours should be excluded from the evaluation, since external exposure 

32 generally controls these radionuclides. 

33 At a minimum, periodic measurements should be conducted annually. Periodic measurements 

34 provide additional information on any long-term accumulation and retention of radioactive 

35 material in the body, especially for exposures to concentrations of airborne radioactive material 

36 below monitoring thresholds. 

37 When an individual is no longer subject to the bioassay program because of change in 

38 employment status, termination bioassay measurement should be made, when practicable, to 

39 ensure that any unknown intakes are quantified.

40 
I–9 

1 Special Monitoring 

2 Because of uncertainty in the time of intakes and the absence of other data related to the 

3 exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to 

4 actual intakes for routine measurements can sometimes be difficult. Abnormal and inadvertent 

5 intakes from situations such as a failed respiratory protective device, inadequate engineering 

6 controls, inadvertent ingestion, contamination of a wound, or skin absorption, should be 

7 evaluated on a case-by-case basis. When determining whether potential intakes should be 

8 evaluated, consider the following circumstances: 

9  the presence of unusually high levels of facial and/or nasal contamination 

10  entry into airborne radioactivity areas without appropriate exposure controls 

11  operational events with a reasonable likelihood that a worker was exposed to unknown 

12 quantities of airborne radioactive material (e.g., loss of system or container integrity) 

13  known or suspected incidents of a worker ingesting radioactive material 

14  incidents that result in contamination of wounds or other skin absorption 

15  evidence of damage to or failure of a respiratory protective device 

16 References: 

17 Regulatory Guide 4.20, Revision 1, “Constraints on Release of Airborne Radioactive Materials 

18 to the Environment for Licensees Other than Power Reactors,” April 2012 

19 Regulatory Guide 8.9, Revision 1, “Acceptable Concepts, Models, Equations, and Assumptions 

20 for a Bioassay Program,” July 1993 

21 Regulatory Guide 8.20, Revision 2, “Applications of Bioassay for Radioiodine,” September 2014, 

22 ADAMS Accession No. ML14064A060 

23 Regulatory Guide 8.23, Revision 1, “Radiation Safety Surveys at Medical Institutions,” 

24 January 1981 

25 Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” June 1992 

26 Regulatory Guide 8.32, “Criteria for Establishing a Tritium Bioassay Program,” July 1988 

27 Regulatory Guide 8.34, “Monitoring Criteria and Methods to Calculate Occupational Radiation 

28 Doses,” July 1992 

29 Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” July 1993 

30 NUREG–1400, “Air Sampling in the Workplace,” September 1993 

31 NUREG–1549, Draft Report for Comment, “Decision Methods for Dose Assessment to Comply 

32 with Radiological Criteria for License Termination,” July 1998, ADAMS Accession 

33 No. ML993250291 
I–10 

1 NUREG–1575, “Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM),” 

2 Revision 1, August 2000 

3 NUREG–1575, Supplement 1, “Multi-Agency Radiation Survey and Assessment of Materials 

4 and Equipment Manual (MARSAME),” January 2009 

5 NUREG–1757, “Consolidated Decommissioning Guidance” 

6  Volume 1, “Decommissioning Process for Materials Licensees (Revision 2),” 

7 September 2006 

8  Volume 2, “Characterization, Survey, and Determination of Radiological Criteria 

9 (Revision 1),” September 2006 

10 NUREG/CR–4884, “Interpretation of Bioassay Measurements,” July 1987 

11 NUREG/CR–5512, Volume 2, “Residual Radioactive Contamination from Decommissioning: 

12 User’s Manual DandD Version 2.1,” April 2001, ADAMS Accession No. ML010940257 

13 NUREG/CR–5512, Volume 3, “Residual Radioactive Contamination from Decommissioning, 

14 Parameter Analysis, Draft Report for Comment,” October 1999 [containing Tables 5-19 

15 (surface contamination) and 6.91 (surface soil)], ADAMS Accession No. ML082460902 

16 Federal Register: “Supplemental Information on the Implementation of the Final Rule on 

17 Radiological Criteria for License Termination,” 63 FR 67132-34, November 18, 1998 

18 Federal Register: “Supplemental Information on the Implementation of the Final Rule on 

19 Radiological Criteria for License Termination,” 64 FR 68395–96, December 7, 1999 

20 Federal Register: “Use of Screening Values to Demonstrate Compliance With the Final Rule on 

21 Radiological Criteria for License Termination,” 65 FR 37186, June 13, 2000 

22 ANSI N13.1-2011, “Sampling and Monitoring Releases of Airborne Radioactive Substances 

23 from the Stacks and Ducts of Nuclear Facilities,” 2011 

24 ANSI N13.30-2011, “Performance Criteria for Radiobioassay,” 2011 

25 ANSI N42.18-2004, “Specification and Performance of On-site Instrumentation for Continuously 

26 Monitoring Radioactivity in Effluents,” 2004 

27 NCRP Commentary No. 3, “Screening Techniques for Determining Compliance with 

28 Environmental Standards–Releases of Radionuclides to the Atmosphere,” published in January 

29 1989, and the addendum published in October 1989 

30 U.S. Department of Energy, DOE G 441.1-1C, Admin Chg 1, “Radiation Protection Programs 

31 Guide for Use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation 

32 Protection,” July 8, 2011 
1 APPENDIX J 

2 MODEL LEAK TEST PROGRAM

J–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, gas-flow proportional counters 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 

 
J–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 Procedure for Performing Leak Testing and Analysis 

16  For each source to be tested, list identifying information such as the sealed source serial 

17 number, manufacturer, model number, radionuclide, and activity. 

18  Use a radiation survey meter to monitor exposure. 

19  Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source. 

20  Number each wipe to correlate with identifying information for each source. 

21  Wipe the most accessible area where contamination would accumulate if the sealed 

22 source were leaking, but do not wipe the surface of a plated or foil source (see 

23 manufacturer’s instructions). 
J–3 

1  Select an instrument 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 Bq (or millicuries). The 

17 activity of the sample in Bq 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 Bq [0.005 microcurie] or greater, notify the RSO so 

21 that the source can be withdrawn from use and disposed of properly. Also notify the 

22 U.S. Nuclear Regulatory Commission.

1 APPENDIX K 

2 U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS 

K–1 

1 U.S. Department of Transportation Regulations 

2 Note: The following list of U.S. Department of Transportation (DOT) regulations is provided to 

3 inform licensees about typical requirements that apply 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 Title 10 of the Code of Federal Regulations (10 CFR) 71.5 requires compliance with DOT 

10 regulations in 49 CFR Parts 107, 171 through 180 and 390 through 397, appropriate to the 

11 mode of transport. The following are the major areas in DOT regulations most relevant for 

12 transporting radioactive materials as Type A or Type B quantities: 

13  Table of Hazardous Materials and Special Provisions—49 CFR 172, Subpart B 

14 — 49 CFR 172.101—Hazardous Materials Table [proper shipping name, hazard 

15 class, identification number] 

16 — 49 CFR 172.101—List of Hazardous Substances and Reportable Quantities, 

17 Table 2 to Appendix A—Radionuclides 

18  Shipping Papers—49 CFR 172, Subpart C 

19 — 49 CFR 172.201—Preparation and retention of shipping papers 

20 — 49 CFR 172.202—Description of hazardous material on shipping papers 

21 — 49 CFR 172.203—Additional description requirements 

22 — 49 CFR 172.204—Shipper’s certification 

23  Marking—49 CFR 172, Subpart D 

24 — 49 CFR 172.300—Applicability 

25 — 49 CFR 172.301—General marking requirements for non-bulk packagings 

26 — 49 CFR 172.304—Marking requirements 

27 — 49 CFR 172.310—Class 7 (radioactive) materials 

28 — 49 CFR 172.324—Hazardous substances in non-bulk packagings [designation of 

29 “reportable quantities” with the letters “RQ”] 

30  Labeling—49 CFR 172, Subpart E 

31 — 49 CFR 172.400—General labeling requirements 

32 — 49 CFR 172.400a—Exceptions from labeling 

33 — 49 CFR 172.401—Prohibited labeling 

34 — 49 CFR 172.403—Class 7 (radioactive) material 

35 — 49 CFR 172.406—Placement of labels 

36 — 49 CFR 172.436—Radioactive White-I label 
K–2 

1 — 49 CFR 172.438—Radioactive Yellow-II label 

2 — 49 CFR 172.440—Radioactive Yellow-III label 

3  Placarding—49 CFR 172, Subpart F 

4 — 49 CFR 172.500—Applicability of placarding requirements 

5 — 49 CFR 172.504—General placarding requirements 

6 — 49 CFR 172.516—Visibility and display of placards 

7 — 49 CFR 172.556—RADIOACTIVE placard 

8  Emergency Response Information—49 CFR 172, Subpart G 

9 — 49 CFR 172.600—Applicability and general requirements 

10 — 49 CFR 172.602—Emergency response information 

11 — 49 CFR 172.604—Emergency response telephone number 

12  Training—49 CFR 172, Subpart H 

13 — 49 CFR 172.702—Applicability and responsibility for training and testing 

14 — 49 CFR 172.704—Training requirements 

15  Safety and Security Plans—49 CFR 172, Subpart I 

16 — 49 CFR 172.800—Purpose and applicability 

17 — 49 CFR 172.802—Components of a security plan 

18  Shippers—General Requirements for Shipments and Packagings—49 CFR Part 173 

19 Class 7 (Radioactive Materials) – Subpart I 

20 — 49 CFR 173.25—Authorized packagings and overpacks 

21 — 49 CFR 173.403—Definitions 

22 — 49 CFR 173.411—Industrial packages 

23 — 49 CFR 173.412—Additional design requirements for Type A packages 

24 — 49 CFR 173.413—Requirements for Type B packages 

25 — 49 CFR 173.415—Authorized Type A packages 

26 — 49 CFR 173.416—Authorized Type B packages 

27 — 49 CFR 173.433—Requirements for determining basic radionuclide values, and 

28 for the listing of radionuclides on shipping papers and labels 

29 — 49 CFR 173.435—Table of A1 and A2 values for radionuclides 

30 — 49 CFR 173.441—Radiation level limitations and exclusive use provisions 
K–3 

1 — 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory Commission 

2 approved packages 

3 — 49 CFR 173.475—Quality control requirements prior to each shipment of Class 7 

4 (radioactive) materials 

5 — 49 CFR 173.476—Approval of special form Class 7 (radioactive) materials 

6  Carriage by Public Highway—49 CFR Part 177 

7 — 49 CFR 177.817—Shipping papers 

8 — 49 CFR 177.842—Class 7 (radioactive) material [includes requirement for 

9 blocking and bracing during transport] 

10 Note: The following reference charts are for reference only and are not a substitute for DOT

11 and U.S. Nuclear Regulatory Commission transportation regulations. 

 
K–4 
K–5 
K–6 
K–7 
K–8 
K–9 
K–10 
K–11 
K–12 
1 APPENDIX L 

2 NRC INCIDENT NOTIFICATIONS

L–1 

1 NRC Incident Notifications 

2 Note: The following list of notification and reporting requirements is provided to inform 

3 licensees about typical notification and reporting requirements that apply to their licensed 

4 activities. 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. 

Event 

Telephone 

Notification 

Written 

Report 

Regulatory 

Requirements 

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 10 CFR 20.1906(d) 

Theft or loss of material immediate 30 days 10 CFR 20.2201(a)(1)(i);

10 CFR 20.2201(b)(1); 

10 CFR 70.50

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); 

10 CFR 70.50 

Extremity dose greater than 

2.5 Gray [250 rads] 

immediate 30 days 10 CFR 

20.2202(a)(1)(iii); 

10 CFR 20.2203(a)(1); 

10 CFR 70.50 

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); 

10 CFR 70.50 

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); 

10 CFR 70.50 

Whole body dose greater than 

0.05 Sv [5 rems] 

None 30 days 10 CFR 20.2203(a)(2)(i);

10 CFR 70.50 

Dose to individual member of 

public greater than 1 mSv 

[100 mrems] 

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); 

10 CFR 70.50 
L–2 

Event 

Telephone 

Notification 

Written 

Report 

Regulatory 

Requirements 

Event that prevents immediate 

protective actions necessary to 

avoid exposure to radioactive 

materials that could exceed 

regulatory limits 

immediate 30 days 10 CFR 70.50(a) & (c)(2)

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 70.50(b)(1) & 

(c)(2) 

Equipment is disabled or fails to 

function as designed when 

required to prevent radiation 

exposure in excess of 

regulatory limits 

24 hours 30 days 10 CFR 70.50(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 70.50(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) 
L–3 

Event 

Telephone 

Notification 

Written 

Report 

Regulatory 

Requirements 

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 

attempts at 

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) 

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) 
L–4 

Event 

Telephone 

Notification 

Written 

Report 

Regulatory 

Requirements 

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 

2 Note: Telephone notifications must be made to the NRC Operations Center at 301-816-5100 or 

3 by facsimile to 301-951-0550, except as noted. The Center is staffed 24 hours a day and 

4 accepts collect calls. NRC notification is required when licensed materials are lost or stolen or 

5 are involved in an incident that may have resulted in doses in excess of NRC limits. 
1 APPENDIX M 

2 CRITERIA FOR ACCEPTABLE TRAINING AND EXPERIENCE FOR 

3 AUTHORIZED USERS 

M–1 

1 Criteria for Acceptable Training and Experience for Authorized Users 

2 This appendix is intended only as a guide for developing a training program. Individuals 

3 working with radionuclides may not require training on every topic provided. For example, 

4 housekeeping staff may need to know only what symbols to look for, which waste cans to 

5 empty, or which areas to enter or avoid. Conversely, laboratory technicians may require 

6 detailed information on particular topics. As a result, instruction for some individuals may be 

7 provided through a simple hand-out, whereas others may require extensive training, including a 

8 written exam to assess retention of the topics presented. 

9 Classroom Training 

10 Classroom training may be in the form of lecture, videotape, or self-study that emphasizes 

11 practical subject matter important to the safe handling of licensed materials. Duration and 

12 technical level of training should be commensurate with the expected hazards encountered 

13 during routine and emergency conditions. Training records should be kept in accordance 

14 with Title 10 of the Code of Federal Regulations (10 CFR)10 CFR 20.2102 and be available 

15 for inspection. 

16 Frequency of Training 

17  Before assuming duties with, or in the vicinity of, radioactive materials 

18  Whenever there is a significant change in duties, regulations, or the terms and 

19 conditions of the license 

20  Annually for refresher training 

21 Suggested Radiation Safety Topics 

22  Fundamentals of Radiation Safety 

23 — Characteristics of radiation 

24 — Units of radiation dose and quantity of radioactivity 

25 — Hazards of exposure to radiation 

26 — Levels of radiation from licensed material 

27 — Methods of controlling radiation dose (time, distance, and shielding) 

28 — Radiation safety practices, including prevention of contamination, and methods 

29 of decontamination 

30 — Discussion of internal exposure pathways 

31  Radiation Detection Instruments 

32 — Use, operation, calibration, and limitations of radiation detection instruments 

33 — Radiation survey techniques for measuring radiation field 
M–2 

1 — Radiation survey techniques for measuring removable/fixed contamination 

2 — Handling and proper use of personnel monitoring equipment 

3  Radiation Protection Equipment and Use 

4 — Proper use of protective equipment 

5 — Decontamination of contaminated protection equipment 

6 — Maintenance of equipment 

7  Storage, control, and disposal of licensed material 

8  U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Parts 19, 20, and 70) 

9  NRC regulations (10 CFR Parts 21, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61, and 71), 

10 as applicable 

11  Licensee’s operating and emergency procedures 

12  Case histories relevant to operations 

13  Course Examination (Didactic) 

14 — Successful completion of closed-book written/oral examination, depending on the 

15 complexity and hazards of authorized activities 

16 — Review of incorrect answers with student 

17  On-the-job Training and Examination (Practical) 

18 — On-the-job training completed under the supervision of a qualified individual 

19 [authorized user (AU), radiation safety officer (RSO), or manufacturer’s 

20 representative authorized by the NRC or an Agreement State] that includes 

21 supervised hands-on experience performing the task authorized on the license 

22 that are commensurate with the expected hazards during routine and emergency 

23 conditions 

24 — Practical examination consisting of an assessment by the RSO to ensure that 

25 each proposed AU is qualified to work independently and that each individual is 

26 knowledgeable of the radiation safety aspects of licensed activities. This may be 

27 demonstrated by observing the proposed AU perform licensed activities. 

28  Discussion and/or drill on all applicable emergency procedures annually 

29  Retraining on areas found to be deficient in both the practical and didactic areas 

30 Classroom Course Instructor Qualifications 

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

32 the qualifications for RSO or AU on the license and is familiar with the licensee’s program). 

33 Instructors who provide classroom training to individuals in the principles of radiation and 

34 radiation safety should have knowledge and understanding of these principles beyond those 
M–3 

1 obtainable in a course similar to the one given to prospective authorized users. Individuals who 

2 provide instruction in the hands-on use of licensed materials should have training and 

3 experience that would qualify them to be authorized users, or should possess a thorough 

4 understanding of the licensee operations.

1 APPENDIX N 

2 MODEL WASTE DISPOSAL PROGRAM

N–1 

1 Model Waste Disposal Program 

2 General Guidelines 

3  All radioactivity labels must be defaced or removed from containers and packages prior 

4 to disposal into ordinary “nonradioactive” waste streams. If waste is compacted, all 

5 labels that are visible in the compacted mass must be defaced or removed. 

6  Remind workers that nonradioactive waste such as leftover reagents, boxes, and 

7 packaging material will not be mixed with radioactive waste. 

8  Occasionally monitor all procedures to ensure that radioactive waste is not created 

9 unnecessarily. Review all new procedures to ensure that waste is handled in a manner 

10 consistent with established procedures. 

11  In all cases, consider the entire impact of various available disposal routes. Consider 

12 occupational and public exposure to radiation, other hazards associated with the 

13 material and routes of disposal (e.g., toxicity, carcinogenicity, pathogenicity, 

14 inflammability), and costs. 

15  The waste management program should include waste-handling procedures for the 

16 users within their laboratories or assigned areas, and for waste handlers who may 

17 collect waste from areas of use to bring to the storage area for eventual disposal. 

18  Housekeeping staff should be provided adequate training to avoid the possibility of 

19 unauthorized disposal or exposure of these individuals to radioactive materials or to 

20 radiation. 

21  A waste generator, collector, or processor who transports, or offers for transportation, 

22 low-level radioactive waste intended for ultimate disposal at a licensed low-level 

23 radioactive waste land disposal facility must prepare a Manifest in accordance with Title 

24 10 of the Code of Federal Regulations (10 CFR) Part 20, Appendix G, “Requirements for 

25 Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land 

26 Disposal Facilities and Manifests.” 

27 Model Procedure for Disposal of Liquids into Sanitary Sewerage 

28  Confirm that the sewer system is a public system, not a private sanitary sewer, septic 

29 system, or leach field. 

30  Confirm that the liquid waste being discharged is soluble (or is biological material that is 

31 readily dispersible) in water. 

32  Calculate the amount of each radionuclide that can be discharged by using the 

33 information from prior, similar discharges and the information in 10 CFR Part 20, 

34 Appendix B. 

35  Make sure that the amount of each radionuclide does not exceed the monthly and 

36 annual discharge limits specified in 10 CFR 20.2003(a)(4) and 10 CFR Part 20, 

37 Appendix B, Table 3. 
N–2 

1  If more than one radionuclide is released, the sum of the ratios of the average monthly 

2 discharge of a radionuclide to the corresponding limit in 10 CFR Part 20, Appendix B, 

3 Table 3 must not exceed unity. 

4  Confirm that the total quantity of licensed material released into the sanitary sewerage 

5 system in a year does not exceed 185 GBq [5 Ci] of H-3 (tritium), 37 GBq [1 Ci] of C-14, 

6 and 37 GBq [1 Ci] of all other radioisotopes combined. 

7  Record the date, radionuclide(s), estimated activity of each radionuclide, location where 

8 the material is discharged, and the name of the individual discharging the waste. 

9  Liquid waste should be discharged only via designated sinks, toilets, or other release 

10 points. 

11  Discharge liquid waste slowly to minimize splashing with water running, to be sure that 

12 the material moves out of the sink and into the sewer system. 

13  Survey the sink and surrounding work surfaces to confirm that no residual material or 

14 contamination remained in the sink or on work surfaces. 

15  Decontaminate all areas or surfaces if found to be contaminated. 

16  Maintain records of releases of licensed material to the sanitary sewer system. These 

17 records should include, for each release, the date, radionuclide(s), estimated activity of 

18 each radionuclide, location where the material is discharged, and the name of the 

19 individual discharging the waste. For the licensed facility as a whole, records should be 

20 maintained of the quantity and concentration of radionuclides that are released into the 

21 sewer system that demonstrate compliance with the regulatory limits for total quantity 

22 released and concentrations released by the licensed facility. 

23 Model Procedure for Compaction 

24 The following information should be provided by licensees that propose to compact waste: 

25  Describe the compactor to demonstrate that it is adequately designed and manufactured 

26 to safely compact the type and quantity of waste generated during licensed operations. 

27 Provide manufacturer’s specifications, annotated sketches or photographs, and other 

28 information about the compactor design. 

29  Describe the type, quantities, and concentrations of waste to be compacted. 

30  Provide an analysis of the potential for airborne release of radioactive material during 

31 compaction activities. 

32  Provide the location of the compactor(s) within the waste processing area(s), as well as 

33 a description of the ventilation and filtration systems used in conjunction with the 

34 compactors. Include a description of the procedures for monitoring filter blockage and 

35 exchange. 

36  Discuss the methods used to monitor worker breathing zones and/or exhaust systems. 
N–3 

1  Discuss the types and frequencies of surveys that will be performed for contamination 

2 control in the compactor area. 

3  Discuss the instruction provided to compactor operators, including instructions for 

4 protective clothing, checks for proper functioning of equipment, method of handling 

5 uncompacted waste, and method of examining containers for defects. 

1 APPENDIX O 

2 CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

3 INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)

O–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 nonproprietary 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 organzation, the 

amount of effort or money expended in developing the information, and the 

ease or difficulty for others to acquire the information. 

1 APPENDIX P 

2 SAFETY CULTURE POLICY STATEMENT 

P–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/ 

4 2011-14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission’s (NRC’s) 

5 Agencywide Documents Access and Management System (ADAMS) Accession 

6 No. ML11146A047. 

7 Safety Culture Policy Statement 

8 The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

9 individuals and organizations establish and maintain a positive safety culture commensurate 

10 with the safety and security significance of their activities and the nature and complexity of their 

11 organizations and functions. This includes all licensees, certificate holders, permit holders, 

12 authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

13 safety-related components, and applicants for a license, certificate, permit, authorization, or 

14 quality assurance program approval, subject to NRC authority. The Commission encourages 

15 the Agreement States, Agreement State licensees, and other organizations interested in nuclear 

16 safety to support the development and maintenance of a positive safety culture, as articulated in 

17 this Statement of Policy. 

18 Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

19 commitment by leaders and individuals to emphasize safety over competing goals to ensure 

20 protection of people and the environment. Individuals and organizations performing regulated 

21 activities bear the primary responsibility for safety and security. The performance of individuals 

22 and organizations can be monitored and trended and, therefore, may be used to determine 

23 compliance with requirements and commitments and may serve as an indicator of possible 

24 problem areas in an organization’s safety culture. The NRC will not monitor or trend values. 

25 These will be the organization’s responsibility as part of its safety culture program. 

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

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

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

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

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

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

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

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

34 with NRC regulated activities. 

35 Experience has shown that certain personal and organizational traits are present in a positive 

36 safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that 

37 emphasizes safety, particularly in goal conflict situations, e.g., production, schedule, and the 

38 cost of the effort versus safety. It should be noted that although the term ‘‘security’’ is not 

39 expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

40 regulatory mission. Consequently, consideration of both safety and security issues, 

41 commensurate with their significance, is an underlying principle of this Statement of Policy. 
P–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; and 

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 inspection 

22 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 the 

28 development of a positive safety culture. The Commission will take this into consideration as 

29 the regulated community addresses the Statement of Policy. 



UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, DC 20555-0001

------------------

OFFICIAL BUSINESS
NUREG-1556, Vol. 17

Revision 1, Draft

Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 

Special Nuclear Material of Less Than Critical Mass Licenses