Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

Medical Use Licenses

Draft Report for Comment

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 9, Rev. 3 

Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

Medical Use Licenses

Draft Report for Comment

Manuscript Completed: November 2016

Date Published: November 2016

Prepared by: 

M. Burkhart 

A. Cockerham

J. Cook

S. Daibes

S. Gabriel

D. B. Howe

P. Lanzisera

T. Simmons

K. Tapp

R. Zelac 

Office of Nuclear Material Safety and Safeguards 

NUREG-1556

Volume 9, Rev. 3 
COMMENTS ON DRAFT REPORT

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

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

specify the report number NUREG-1556, Volume 9 in your comments, and send them by the 

end of the comment period specified in the Federal Register notice announcing the availability 

of this report. 

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

Docket ID NRC-2016-0122 in the subject line of your comments. Comments submitted in 

writing or in electronic form will be posted on the NRC website and on the Federal rulemaking 

website http://www.regulations.gov. 

Federal Rulemaking Website: Go to http://www.regulations.gov and search for documents 

filed under Docket ID NRC-2016-0122. Address questions about NRC dockets to Carol 

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

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

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

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

For any questions about the material in this report, please contact: Katie Tapp, Ph.D., at 301-

415-0236 or by e-mail at Katherine.Tapp@nrc.gov. 

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

record and entered into the Agencywide Documents Access and Management System 

(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 the medical 

4 use of byproduct material. In particular, it describes the types of information needed to 

5 complete U.S. Nuclear Regulatory Commission (NRC) Form 313, “Application for Materials 

6 License,” and the NRC Form 313A series for authorized users (AU), authorized medical 

7 physicists (AMP), authorized nuclear pharmacists (ANP), and Radiation Safety Officers (RSO). 

8 This document describes both the methods acceptable to the NRC license reviewers in 

9 implementing the regulations and the techniques used by the reviewers in evaluating the 

10 application to determine if the proposed activities are acceptable for licensing purposes. 

11 The document contains appendices that include (i) copies of necessary forms; (ii) a sample 

12 license application for different types of medical uses of byproduct materials; and (iii) examples 

13 of the types of supporting documents, such as procedures, that may need to be prepared by 

14 applicants. Guidance in this document represents one means acceptable to NRC staff of 

15 complying with NRC regulations and is not intended to be the only means of satisfying 

16 requirements for a license. 

17 Paperwork Reduction Act Statement 

18 This NUREG references information collection requirements that are subject to the Paperwork 

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

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

21 3150-0035; 3150-0017; 3150-0015; 3150-0010; 3150-0009; 3150-0008; 3150-0120; and 

22 3150-0028. 

23 

24 Public Protection Notification 

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

26 information or an information collection requirement unless the requesting documents displays a 

27 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 Materials Using an Accelerator 

 
vi 

1 The current document, NUREG–1556, Volume 9, Revision 3, “Program-Specific Guidance 

2 About Medical Use Licenses,” is intended for use by applicants, licensees, and other NRC staff. 

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

4 Volume 9, Revision 2, January 2008. See Appendix AA of this NUREG for a list of documents 

5 considered in the development of this NUREG–1556 report. 

6 This report takes a risk-informed, performance-based approach to licensing the use of 

7 byproduct material for medical uses. A team composed of staff from NRC Headquarters, NRC 

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

9 experience in radiation safety in general and as specifically applied to medical uses of 

10 byproduct material. 

11 The Medical Uses Licensee Toolkit, which contains the following items, serves as another 

12 source of guidance for the implementation of Title 10 of the Code of Federal Regulations (CFR) 

13 10 CFR Part 35: 

14  questions and answers on the implementation of 10 CFR Part 35 

15  specialty board certifications recognized by NRC 

16  Inspection Procedures for inspections of medical use licensees 

17  other guidance for emerging technology (10 CFR 35.1000) [e.g., Yttrium-90 Microsphere 

18 Brachytherapy, Leksell Gamma Knife Perfexion] 

19  list server subscription for automatic e-mail notifications of medical-related generic 

20 communications, Federal Register Notices, and NRC newsletters 

21  forms (e.g., Training and Experience for authorized users, authorized medical physicists, 

22 authorized nuclear pharmacists, and radiation safety officers; License Applications; 

23 Disposition of Materials) 

24 NUREG–1556, Volume 9, Revision 3, is not a substitute for NRC or Agreement State 

25 regulations. The approaches and methods described in this report are provided for information 

26 only. Methods and solutions different from those described in this report may be acceptable, if 

27 they include a basis for the staff to make the determinations needed to issue or renew a license. 

_________________________________________ 

28 Daniel Collins, Director 

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

30 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 OVERVIEW .................................................................................................................... 1-1

9 1.1 Purpose of Report .............................................................................................. 1-1

10 1.2 Types of Licenses .............................................................................................. 1-6

11 1.2.1 Specific License of Limited Scope .......................................................... 1-8

12 1.2.2 Specific License of Broad Scope ............................................................ 1-8

13 1.2.3 Research Involving Human Subjects ...................................................... 1-8

14 1.2.4 General In Vitro License ......................................................................... 1-9

15 1.3 Other Requirements ........................................................................................... 1-9

16 1.3.1 The “As-Low-As-Reasonably-Achievable (ALARA) Concept ................. 1-9

17 1.3.2 Office of Management and Budget (OMB) Clearances ........................ 1-10

18 2 AGREEMENT STATES ................................................................................................. 2-1

19 2.1 Jurisdiction Determination .................................................................................. 2-1

20 2.2 Reciprocal Recognition of Specific Licenses ...................................................... 2-3

21 3 MANAGEMENT RESPONSIBILITY .............................................................................. 3-1

22 3.1 Commitments and Responsibilities .................................................................... 3-1

23 3.2 Safety Culture ..................................................................................................... 3-2

24 4 APPLICABLE REGULATIONS ..................................................................................... 4-1

25 5 HOW TO FILE ................................................................................................................ 5-1

26 5.1 Application Preparation ...................................................................................... 5-1

27 5.2 Where to File ...................................................................................................... 5-1

28 5.3 Paper Applications ............................................................................................. 5-2

29 5.4 Electronic Applications ....................................................................................... 5-2

30 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION ................................. 6-1

31 7 APPLICATION AND LICENSE FEES ........................................................................... 7-1

32 8 CONTENTS OF AN APPLICATION .............................................................................. 8-1

33 8.1 Item 1: License Action Type .............................................................................. 8-2

34 8.2 Item 2: Name and Mailing Address of Applicant................................................ 8-2

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

36 or Possessed .......................................................................................... 8-3

37 8.4 Item 4: Person To Be Contacted About This Application .................................. 8-4

38 8.5 Item 5: Radioactive Material .............................................................................. 8-5

39 8.5.1 Byproduct Material and Depleted Uranium ............................................. 8-5

40 8.5.2 Financial Assurance and Recordkeeping for Decommissioning ............. 8-9

41 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used ........................ 8-11
viii 

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

2 Their Training and Experience .............................................................. 8-12

3 8.7.1 Radiation Safety Officer (RSO) ............................................................. 8-14

4 8.7.2 Authorized Users (AUs) ........................................................................ 8-19

5 8.7.3 Authorized Nuclear Pharmacist (ANP) ................................................. 8-24

6 8.7.4 Authorized Medical Physicist (AMP) ..................................................... 8-27

7 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted 

8 Areas .................................................................................................... 8-29

9 8.9 Item 9: Facilities and Equipment ..................................................................... 8-31

10 8.9.1 Facility Diagram .................................................................................... 8-32

11 8.9.2 Radiation Monitoring Instruments ......................................................... 8-38

12 8.9.3 Dose Calibrator and Other Equipment Used to Measure 

13 Dosages of Unsealed Byproduct Material ............................................ 8-40

14 8.9.4 Therapy Unit – Calibration and Use ...................................................... 8-42

15 8.9.5 Other Equipment and Facilities ............................................................. 8-44

16 8.10 Item 10: Radiation Safety Program ................................................................. 8-47

17 8.10.1 Audit Program .................................................................................... 8-48

18 8.10.2 Occupational Dose ............................................................................ 8-49

19 8.10.3 Public Dose ........................................................................................ 8-55

20 8.10.4 Operating and Emergency Procedures ............................................. 8-56

21 8.10.5 Spill/Contamination Procedures ........................................................ 8-59

22 8.10.6 Emergency Procedures for Therapy Devices Containing 

23 Sealed Sources ................................................................................. 8-60

24 8.10.7 Installation, Maintenance, Adjustment, Repair, and Inspection 

25 of Therapy Devices Containing Sealed Sources ............................... 8-62

26 8.10.8 Ordering and Receiving ..................................................................... 8-63

27 8.10.9 Opening Packages ............................................................................ 8-63

28 8.10.10 Material Receipt and Accountability .................................................. 8-64

29 8.10.11 Leak Tests ........................................................................................ 8-66

30 8.10.12 Sealed Source Inventory .................................................................. 8-67

31 8.10.13 Area Surveys .................................................................................... 8-67

32 8.10.14 Procedures for Administrations When a Written Directive 

33 Is Required ....................................................................................... 8-70

34 8.10.15 Safe Use of Unsealed Licensed Material .......................................... 8-71

35 8.10.16 Safety Procedures for Treatment When Patients 

36 are Hospitalized ................................................................................ 8-72

37 8.10.17 Mobile Medical Service ..................................................................... 8-73

38 8.10.18 Release of Patients or Human Research Subjects ........................... 8-75

39 8.10.19 Minimization of Contamination .......................................................... 8-76

40 8.10.20 Records of Dosages and Use of Brachytherapy Sources ................. 8-76

41 8.10.21 Recordkeeping .................................................................................. 8-78

42 8.10.22 Reporting .......................................................................................... 8-78

43 8.10.23 Transportation ................................................................................... 8-79

44 8.10.24 Security Program for Category 1 and Category 2 

45 Radioactive Material ......................................................................... 8-81

46 8.11 Item 11: Waste Management .......................................................................... 8-82

47 8.12 Item 12: License Fees ..................................................................................... 8-87

48 8.13 Item 13: Certification ....................................................................................... 8-88

49 9 LICENSE AMENDMENTS AND RENEWALS ............................................................... 9-1

50 9.1 Timely Submittals of Amendments and Renewals ............................................. 9-1
ix 

1 9.2 Timely Notification of Transfer of Control ........................................................... 9-2

2 9.2.1 Transfer of Control .................................................................................. 9-2

3 9.2.2 Notification of Bankruptcy Proceedings .................................................. 9-3

4 9.2.3 Other ....................................................................................................... 9-3

5 10 APPLICATIONS FOR EXEMPTIONS ......................................................................... 10-1

6 11 TERMINATION OF ACTIVITIES ................................................................................. 11-1

7 

8 APPENDICES 

9 APPENDIX A SAFETY CULTURE POLICY STATEMENT ............................................... A–1 

10 APPENDIX B U.S. NUCLEAR REGULATORY COMMISSION FORM 313 ...................... B–1 

11 APPENDIX C LICENSE APPLICATION CHECKLISTS .................................................... C–1 

12 APPENDIX D DOCUMENTATION OF TRAINING AND EXPERIENCE TO IDENTIFY 

13 INDIVIDUALS ON A LICENSE.................................................................... D–1 

14 APPENDIX E U.S. NUCLEAR REGULATORY COMMISSION FORM 313A (AUD) ......... E–1 

15 APPENDIX F CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

16 INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390) ... F–1 

17 APPENDIX G MODEL PROCEDURES FOR DOSE CALIBRATOR CALIBRATION ....... G–1 

18 APPENDIX H MODEL PROCEDURES FOR REMOTE AFTERLOADER 

19 SPOT-CHECKS ........................................................................................... H–1 

20 APPENDIX I RADIATION SAFETY OFFICER DUTIES, RESPONSIBILITES, AND 

21 DELEGATION ............................................................................................... I–1 

22 APPENDIX J MODEL TRAINING PROGRAM ................................................................... J–1 

23 APPENDIX K GENERAL RADIATION MONITORING INSTRUMENT 

24 SPECIFICATIONS AND SURVEY INSTRUMENT 

25 CALIBRATION PROGRAM......................................................................... K–1 

26 APPENDIX L MODEL MEDICAL LICENSEE AUDIT ......................................................... L–1 

27 APPENDIX M MODEL PROCEDURES FOR OCCUPATIONAL DOSE PROGRAM ........ M–1 

28 APPENDIX N MODEL EMERGENCY PROCEDURES...................................................... N–1 

29 APPENDIX O MODEL PROCEDURES FOR ORDERING AND RECEIVING 

30 PACKAGES ................................................................................................. O–1 

31 APPENDIX P MODEL PROCEDURES FOR SAFELY OPENING PACKAGES 

32 CONTAINING RADIOACTIVE MATERIAL .................................................. P–1 

33 APPENDIX Q MODEL LEAK TEST PROGRAM ............................................................... Q–1 

34 APPENDIX R MODEL PROCEDURES FOR AREA SURVEY .......................................... R–1 

35 APPENDIX S MODEL PROCEDURES FOR DEVELOPING, MAINTAINING, AND 

36 IMPLEMENTING WRITTEN DIRECTIVES ................................................... S–1 

37 APPENDIX T MODEL PROCEDURES FOR SAFE USE OF UNSEALED LICENSED 

38 MATERIAL ................................................................................................... T–1 

39 APPENDIX U MODEL PROCEDURES FOR RELEASE OF PATIENTS OR HUMAN 

40 RESEARCH SUBJECTS ADMINISTERED RADIOACTIVE 

41 MATERIALS ................................................................................................ U–1 

42 APPENDIX V RADIOACTIVE MATERIALS GUIDANCE FOR MOBILE MEDICAL 

43 SERVICES .................................................................................................... V–1 

44 APPENDIX W MODEL PROCEDURES FOR WASTE DISPOSAL BY 

45 DECAY-IN-STORAGE, GENERATOR RETURN, AND LICENSED 

46 MATERIAL RETURN .................................................................................. W–1 

47 APPENDIX X RECORDKEEPING REQUIREMENTS ........................................................ X–1 

48 APPENDIX Y REPORTING REQUIREMENTS ................................................................... Y–1 
x 

1 APPENDIX Z SUMMARY OF DOT REQUIREMENTS FOR TRANSPORTATION 

2 OF TYPE A, TYPE B, OR LIMITED QUANTITIES OF LICENSED 

3 MATERIAL ................................................................................................... Z–1 

4 APPENDIX AA LIST OF REFERENCES AND RESOURCES ........................................... AA–1
xi 

1 FIGURES 

2 Figure Page 

3 2-1 U.S. Map: Locations of NRC Offices and Agreement States ........................................ 2-1 

4 8-1 Location of Use .............................................................................................................. 8-3 

5 8-2 Facility Diagram for Nuclear Medicine Suite ................................................................ 8-34 

6 8-3 Facility Diagram for PET Suite ..................................................................................... 8-35 

7 8-4 Facility Diagram for HDR Suite .................................................................................... 8-37 

8 8-5 Annual Occupational Dose Limits for Adults ................................................................ 8-51 

9 TABLES 

10 Table Page 

11 1-1 Sections of NUREG–1556, Volume 9, Revision 3, That Applicants for a 

12 Particular Type of Use Should Review ........................................................................... 1-2 

13 2-1 Who Regulates the Activity? .......................................................................................... 2-2 

14 3-1 Traits of a Positive Safety Culture .................................................................................. 3-3

15 8-1 Worksheet for Determining Need for Financial Assurance for Sealed Sources ........... 8-10 

16 8-2 Guidance on Personnel Monitoring and Bioassay ....................................................... 8-53 

17 C–1 Items 5 and 6 on NRC Form 313: Radioactive Material and Use ............................... C–2 

18 C–2 Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

19 and Equipment, Radiation Protection Program, and Waste Disposal .......................... C–7 

20 C–3 Applicable Appendices Describing Model Procedures ............................................... C–16 

21 K–1 Typical Survey Instruments ........................................................................................... K–1 

22 M–1 Investigational Levels ................................................................................................... M–4 

23 N–1 Relative Hazards of Common Radionuclides ............................................................... N–2 

24 R–1 Ambient Dose Rate Trigger Levels .............................................................................. R–2 

R–2 Surface Contamination Levels in Restricted Areas(dpm/100 cm2 25 ) .............................. R–3 

R–3 Surface Contamination Levels in Unrestricted Areas (dpm/100 cm2 26 ) .......................... R–4 

27 U–1 Activities and Dose Rates for Authorizing Patient Release .......................................... U–5 

28 U–2 Activities and Dose Rates Above Which Instructions Should Be Given When 

29 Authorizing Patient Release ......................................................................................... U–8 

30 U–3 Activities of Radiopharmaceuticals That Require Instructions and Records 

31 When Administered to Patients Who Are Breastfeeding an Infant or Child ................. U–9 

32 U–4 Summary of Release Criteria, Required Instructions to Patients, and 

33 Records To Be Maintained ......................................................................................... U–14 

34 U–5 Half-Lives and Exposure Rate Constants of Radionuclides Used in Medicine .......... U–15
xii 

1 U–6 Uptake Fractions and Effective Half-Lives For Sodium-Iodide 

2 Iodine-131 Treatments ............................................................................................... U–21 

3 X–1 Typical Records and Retention Times .......................................................................... X–1 

4 Y–1 Typical NRC Notifications and/or Reports ..................................................................... Y–1 
xiii 

1 ACKNOWLEDGMENTS 

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

3 Regulatory Commission, the Advisory Committee on the Medical Uses of Isotopes, and all of 

4 the States who provided comments and technical information that assisted in the development 

5 of this report. 

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

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

8 parts of the report. Lastly, the working group thanks Dr. Vincent Holahan and Jeff Kowalczik for 

9 providing technical information and support. 

10 The Participants for this Revision 

11 Cockerham, Ashley 

12 Cook, Jackie 

13 Daibes, Said 

14 Gabriel, Sandra 

15 Howe, Donna Beth 

16 Lanzisera, Penny 

17 Simmons, Toye 

18 Tapp, Katie 

19 Zelac, Ron 

xv 

1 ABBREVIATIONS 

2 AAPM American Association of Physicists in Medicine 

3 AEA Atomic Energy Act 

4 ACMUI Advisory Committee on the Medical Use of Isotopes 

5 ALARA as low as is reasonably achievable 

6 ALI annual limit on intake 

7 AMP authorized medical physicist 

8 ANP authorized nuclear pharmacist 

9 ANSI American National Standards Institute 

10 AU authorized user 

11 AUD Authorized User Diagnostic 

12 AUS Authorized User Sealed Source 

13 AUT Authorized User Therapy 

14 bkg background 

15 Bq becquerel 

16 CEDE committed effective dose equivalent 

17 CFR Code of Federal Regulations

18 Ci curie 

19 cc cubic centimeter 

20 cm centimeter 

cm2 21 square centimeter 

22 Co-57 cobalt-57 

23 cpm counts per minute 

24 Cs-137 cesium-137 

25 DAC derived air concentration 

26 DDE deep-dose equivalent 

27 DOT U.S. Department of Transportation 

28 dpm disintegrations per minute 

29 FDA U.S. Food and Drug Administration 

30 GBq gigabecquerel 

31 GM Geiger-Mueller 

32 GSR gamma stereotactic radiosurgery 

33 HDR high-dose rate 

34 h hour 

35 I-125 iodine-125 

36 I-131 iodine-131 

37 ICRP International Commission on Radiological Protection 

38 IN Information Notice 

39 Ir-192 iridium-192 

40 kBq kilobecquerel 

41 L/C License Condition 

42 LDR low-dose rate 

43 MBq megabecquerels 

44 MDR medium-dose rate 

45 mGy milliGray 

46 MML Master Materials License 

47 mCi millicurie 

48 mg milligram

49 Mo-99 molybdenum-99 

50 mR milliroentgen 
xvi 

1 mrad millirad 

2 mrem millirem 

3 mSv millisievert 

4 NaI sodium iodide 

5 NARM Naturally Occurring and Accelerator-Produced Material 

6 NCRP National Council on Radiation Protection and Measurements 

7 NIST National Institute of Standards and Technology 

8 NMSS Office of Nuclear Material Safety and Safeguards 

9 NRC U.S. Nuclear Regulatory Commission 

10 NSTS National Source Tracking System 

11 NSTTR National Source Tracking Transaction Report 

12 NVLAP National Voluntary Laboratory Accreditation Program 

13 OMB Office of Management and Budget 

14 PET Positron Emission Tomography 

15 P-32 phosphorus-32 

16 PDR pulsed dose-rate 

17 PII Personally Identifiable Information 

18 Q quality factor 

19 QA quality assurance 

20 R roentgen 

21 Ra-226 radium-226 

22 Rb-82 rubidium-82 

23 RG Regulatory Guide 

24 RIS Regulatory Issue Summary 

25 RSC Radiation Safety Committee 

26 RSO Radiation Safety Officer 

27 SDE shallow-dose equivalent 

28 SLN sentinel lymph node 

29 Sr-82 strontium-82 

30 Sr-85 strontium-85 

31 Sr-90 strontium-90 

32 SSD sealed source and device 

33 std standard 

34 Sv Sievert 

35 Tc-99m technetium-99m 

36 TEDE total effective dose equivalent 

37 TI Transport Index 

38 TLD thermoluminescent dosimeters 

39 U-235 uranium-235 

40 UN United Nations 

41 U.S.C. United States Code 

42 WD written directive 

43 Y-90 yttrium-90 

44 yr year 

45 μCi microcurie 

46 μGy microGray

47 % percent 
1-1 

1 1 OVERVIEW 

2 1.1 Purpose of Report 

3 This report provides guidance to an applicant applying for medical 

4 use of byproduct material and also provides the U.S. Nuclear 

5 Regulatory Commission (NRC) staff with the criteria for evaluating 

6 such applications. This document uses the terms “byproduct 

7 material,” “licensed material,” and “radioactive material” 

8 interchangeably. 

9 Chapter 8, “Contents of an Application,” of this report identifies the 

10 information needed to complete the following application forms: NRC 

11 Form 313, “Application for Materials License” (see Appendix B of this NUREG), for medical use 

12 of byproduct material. Additionally, this report provides instructions and examples for 

13 completing the following supplemental NRC Form 313A series forms found in Appendix E: 

14  NRC Form 313A (RSO), “Radiation Safety Officer Medical Use Training and Experience 

15 Preceptor Attestation [10 CFR 35.50]” 

16  NRC Form 313A (AMP), “Authorized Medical Physicist Training and Experience and 

17 Preceptor Attestation [10 CFR 35.51]” 

18  NRC Form 313A (ANP), “Authorized Nuclear Pharmacist Training and Experience and 

19 Preceptor Attestation [10 CFR 35.55]” 

20  NRC Form 313A (AUD), “Authorized User Training and Experience and Preceptor 

21 Attestation (for uses defined under 10 CFR 35.100, 35.200, and 35.500) 

22 [10 CFR 35.190, 35.290, and 35.590]” 

23  NRC Form 313A (AUT), “Authorized User Training and Experience and Preceptor 

24 Attestation (for uses defined under 10 CFR 35.300) [10 CFR 35.390, 35.392, 35.394, 

25 and 35.396]” 

26  NRC Form 313A (AUS), “Authorized User Training and Experience and Preceptor 

27 Attestation (for uses defined under 10 CFR 35.400 and 35.600) [10 CFR 35.490, 35.491, 

28 and 35.690]” 

29 This report outlines NRC criteria for evaluating a medical use license application and provides 

30 guidance for the following types of medical uses of byproduct material: 

31  use of unsealed byproduct material for uptake, dilution, and excretion studies for which a 

32 written directive (WD) is not required under Title 10 of the Code of Federal Regulations

33 (CFR) 10 CFR 35.40, “Written Directives” (see Subpart D, 10 CFR 35.100-190) 

34  use of unsealed byproduct material for imaging and localization studies for which a 

35 written directive (WD) is not required under 10 CFR 35.40 (see Subpart D, 

36 10 CFR 35.200-290) 

37  use of unsealed byproduct material for which a WD is required under 10 CFR 35.40 

38 (see Subpart E, 10 CFR 35.300-396) 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
1-2 

1  use of sources for manual brachytherapy (see Subpart F, 10 CFR 35.400-491) 

2  use of sealed sources for diagnosis (see Subpart G, 10 CFR 35.500-590) 

3  use of a sealed source in a photon-emitting remote afterloader unit, teletherapy unit, or 

4 gamma stereotactic radiosurgery unit (see Subpart H, 10 CFR 35.600-690) 

5  other medical uses of byproduct material or radiation from byproduct material not 

6 specifically covered by 10 CFR Part 35, “Medical Use of Byproduct Material,” Subparts 

7 35.100 through 35.600 (see 10 CFR 35.1000, Subpart K) 

8 To assist applicants, this report includes gray text boxes at the beginning of each section to 

9 indicate the type of use to which the guidance pertains. These boxes are intended to guide the 

10 applicant through the sections of the guidance that are relevant to the applicant's particular type 

11 of use of byproduct material. A bullet indicates that applicants for that type of use should review 

12 the guidance section. Table 1-1 summarizes the material in the text boxes. 

Table 1-1. Sections of NUREG–1556, Volume 9, Revision 3, That Applicants for a 

Particular Type of Use Should Review 

NUREG–1556-Volume 9, Rev. 3 Section:

Type of Part 35 Use

100 200 300 400 500 600 1000

8.1 License Action Type ● ● ● ● ● ● ●

8.2 Name and Mailing Address of Applicant ● ● ● ● ● ● ●

8.3 Address(es) Where Licensed Material Will 

Be Used or Possessed 

● ● ● ● ● ● ●

8.4 Person to Be Contacted about This 

Application 

● ● ● ● ● ● ●

8.5.1 Byproduct Material and Depleted Uranium ● ● ● ● ● ● ●

8.5.2 Financial Assurance and Recordkeeping 

for Decommissioning 

● ● ● ● ● ● ●

8.6 Purpose(s) for which Licensed Material 

Will Be Used 

● ● ● ● ● ● ●

8.7 Individual(s) Responsible for Radiation 

Safety Program and their Training and 

Experience 

● ● ● ● ● ● ●

8.7.1 Radiation Safety Officer (RSO) ● ● ● ● ● ● ●

8.7.2 Authorized Users (AUs) ● ● ● ● ● ● ●

8.7.3 Authorized Nuclear Pharmacist (ANP) ● ● ● ●

8.7.4 Authorized Medical Physicist (AMP) ● ● ●

8.8 Training for Individuals Working In or 

Frequenting Restricted Areas 

● ● ● ● ● ● ●

8.9 Facilities and Equipment ● ● ● ● ● ● ●

8.9.1 Facility Diagram ● ● ● ● ● ● ●

8.9.2 Radiation Monitoring Instruments ● ● ● ● ● ● ●

8.9.3 Dose Calibrator and Other Equipment 

Used to Measure Dosages of Unsealed 

Byproduct Material 

● ● ● ●

8.9.4 Therapy Unit - Calibration and Use ● ● ●

8.9.5 Other Equipment and Facilities ● ● ● ● ● ● ●

8.10 Radiation Protection Program ● ● ● ● ● ● ●
1-3 

Table 1-1. Sections of NUREG–1556, Volume 9, Revision 3, That Applicants for a 

Particular Type of Use Should Review

NUREG–1556-Volume 9, Rev. 3 Section:

Type of Part 35 Use

100 200 300 400 500 600 1000

8.10.1 Audit Program ● ● ● ● ● ● ●

8.10.2 Occupational Dose ● ● ● ● ● ● ●

8.10.3 Public Dose ● ● ● ● ● ● ●

8.10.4 Operating and Emergency Procedures ● ● ● ● ● ● ●

8.10.5 Spill/Contamination Procedures ● ● ● ● ● ● ●

8.10.6 Emergency Procedures for Therapy 

Devices Containing Sealed Sources 

 ● ●

8.10.7 Installation, Maintenance, Adjustment, 

Repair, and Inspection of Therapy Devices 

Containing Sealed Sources 

 ● ●

8.10.8 Ordering and Receiving ● ● ● ● ● ● ●

8.10.9 Opening Packages ● ● ● ● ● ● ●

8.10.10 Material Receipt and Accountability ● ● ● ● ● ● ●

8.10.11 Leak Tests ● ● ● ● ● ● ●

8.10.12 Sealed Source Inventory ● ● ● ● ● ● ●

8.10.13 Area Surveys ● ● ● ● ● ● ●

8.10.14 Procedures for Administrations When a 

Written Directive Is Required 

 ● ● ● ●

8.10.15 Safe Use of Unsealed Licensed Material ● ● ● ●

8.10.16 Safety Procedures for Treatments When 

Patients Are Hospitalized 

 ● ● ● ●

8.10.17 Mobile Medical Service ● ● ● ● ● ● ●

8.10.18 Release of Patients or Human Research 

Subjects 

 ● ● ●

8.10.19 Minimization of Contamination ● ● ● ● ● ● ●

8.10.20 Records of Dosages and Use of 

Brachytherapy Source 

● ● ● ● ●

8.10.21 Recordkeeping ● ● ● ● ● ● ●

8.10.22 Reporting ● ● ● ● ● ● ●

8.10.23 Transportation ● ● ● ● ● ● ●

8.10.24 Security Program for Category 1 and 

Category 2 Materials 

 ● ● ●

8.11 Waste Management ● ● ● ● ● ● ●

8.12 License Fees ● ● ● ● ● ● ●

8.13 Certification ● ● ● ● ● ● ●

1 Applicants should also be aware that 10 CFR Part 35 contains general information, 

2 administrative requirements, and technical requirements that are pertinent to some or all of the 

3 types of use listed above. See 10 CFR 35.1 through 35.92. 

 
1-4 

1 This report is intended to consolidate, into one document, guidance that relates to 

2 satisfying regulations other than 10 CFR Part 35 that apply to medical use licensees, including 

3 the following: 

4  provisions of 10 CFR Part 20, “Standards for Protection Against Radiation,” that relate to 

5 radiation safety 

6  provisions of 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of 

7 Byproduct Material,” that relate to licensing (e.g., 10 CFR 30.33, “General requirements 

8 for issuance of specific licenses”) 

9 This report does not address certain aspects of licensing and radiation safety for the 

10 medical use of byproduct materials. In particular, applicants and licensees should consider 

11 the following: 

12  NUREG–1556, Volume 15, “Guidance About Changes of Control and About Bankruptcy 

13 Involving Byproduct, Source, or Special Nuclear Materials Licenses” 

14  10 CFR Part 19, “Notices, Instructions, and Reports to Workers: Inspection and 

15 Investigations” 

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

17 Other regulatory requirements potentially applicable to medical use licensees listed in 

18 Chapter 4, “Applicable Regulations” Section 1.2.2, “Specific License of Broad Scope,” provides 

19 a general discussion on specific licenses of broad scope. NUREG–1556, Volume 11, 

20 “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses 

21 of Broad Scope,” provides additional licensing guidance on medical use programs of 

22 broad scope. 

23 This report does not address the commercial aspects of manufacturing, distribution, and service 

24 of sources containing byproduct material in devices. Licensees should review NUREG–1556, 

25 Volume 12, “Program-Specific Guidance About Possession Licenses for Manufacturing and 

26 Distribution,” and NUREG–1556, Volume 18, “Program-Specific Guidance About Service 

27 Provider Licenses.” 

28 This report does not address the accelerator production of radionuclides by the medical use 

29 licensee for either commercial or noncommercial distribution of radionuclides. Licensees should 

30 review NUREG–1556, Volume 13, “Program-Specific Guidance About Commercial 

31 Radiopharmacy Licenses,” and NUREG–1556, Volume 21, “Program-Specific Guidance About 

32 Possession Licenses for Production of Radioactive Material Using an Accelerator,” for additional 

33 guidance. “Consortium,” as used here and in 10 CFR Part 30, is defined as an association of 

34 medical use licensees and a Positron Emission Tomography (PET) radionuclide production 

35 facility in the same geographical area that jointly own or share in the operation and maintenance 

36 cost of the PET radionuclide production facility that produces PET radionuclides for use in 

37 producing radioactive drugs within the consortium for noncommercial distribution among its 

38 associated members for medical use. The PET radionuclide production facility within the 

39 consortium must be located at an educational institution, a Federal facility, or a medical facility. 

40 Specific guidance for applicants requesting authorization to produce radioactive material using 

41 an accelerator is included in NUREG–1556, Volume 21, “Consolidated Guidance About 
1-5 

1 Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of 

2 Radioactive Material Using an Accelerator,” and is not within the scope of this guidance for 

3 medical use licensees. Note that this guidance should be used for the activities that take place 

4 after the radiochemical is produced, which would include the radiochemistry or compounding of 

5 the radiochemical into a radiopharmaceutical by an ANP or qualified AU for the applicant’s 

6 medical use. 

7 As a guidance document intended to assist a wide variety of applicants, this report contains a 

8 considerable amount of information about how licensees may choose to implement programs to 

9 meet NRC regulatory requirements. The information in this document is not intended to impose 

10 any conditions beyond those required by the regulations in 10 CFR. This report provides 

11 specific guidance on what information should be submitted in an application to satisfy NRC 

12 requirements. Except for procedures required by Subpart H, “Photon Emitting Remote 

13 Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units,” of 

14 10 CFR Part 35, written procedures do not need to be submitted as part of the 

15 license application. 

16 Guidance and model procedures provided in this NUREG that are not required to be submitted 

17 are for illustrative purposes to guide licensees in developing programs. Use of the word 

18 “should” implies “may” and is not intended to mean “must” or “shall;” the procedures provided in 

19 this guidance are intended to serve only as examples. 

20 Chapters 1 through 7 of this document provide background information. Chapter 8 describes, 

21 item by item, the information that should be provided in Items 1 through 11 of NRC Form 313, in 

22 completing a license application. 

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

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

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

26  Discussion—provides additional information about the topic. 

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

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

29 licensing process. 

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

31 NRC Form 313. 

32 Some sections of the guidance include references to other documents or resources that may be 

33 useful to the applicant. Appendix AA of this NUREG provides a complete list of documents that 

34 were used to prepare or are referenced in this guidance. If reference or resource documents 

35 or resources include information conflicting with current regulations, the regulations in 10 CFR 

36 apply. For example, some references or resources may include alternate limits for occupational 

37 and public dose; however, licensees should note that the limits in 10 CFR Part 20 are 

38 applicable. Many of the documents may be accessed online at the NRC Library or using the 

39 links provided in Appendix AA of this NUREG. See the Notice of Availability on the inside front 

40 cover of this report for more information. 
1-6 

1 NRC Form 313 does not have sufficient space to provide full responses to Items 5 through 11, 

2 as indicated on the form. Applicants should address those items on separate sheets of paper 

3 and submit them along with the completed NRC Form 313. For the convenience and 

4 streamlined handling of medical use applications, Appendix C of this NUREG may be used to 

5 provide supporting information. Additionally, Appendix D of this NUREG describes how to fill 

6 out the NRC Form 313A series of forms. 

7 Other appendices to this report provide the following supplementary information: 

8  Appendix A provides a copy of the NRC’s Safety Culture Policy Statement. 

9  Appendix F provides a checklist for withholding proprietary information. 

10  Appendices G through W provide model procedures. 

11  Appendices X, Y, and Z provide recordkeeping, reporting, and transportation 

12 requirements, respectively. 

13  Appendix AA provides a list of references and resources. 

14 In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose 

15 equivalent, committed dose equivalent, committed effective dose equivalent, or total effective 

16 dose equivalent, as defined in 10 CFR Part 20. To describe units of radiation exposure or dose, 

17 rem and its International System of Units equivalent, sievert (Sv) (1 rem = 0.01 Sv), are used. 

18 This is because 10 CFR Part 20 sets dose limits in terms of rem (Sv), rather than rad or 

19 roentgen. When the radioactive material emits beta and gamma rays, 1 roentgen is assumed to 

20 equal 1 rad, which is assumed to equal 1 rem. For alpha and neutron-emitting radioactive 

21 material, 1 rad is not equal to 1 rem. Determination of dose equivalent (rem) from absorbed 

22 dose (rad) from alpha particles and neutrons requires the use of an appropriate quality factor 

23 (Q) value. These Q values are used to convert absorbed dose (rad) to dose equivalent (rem); 

24 Tables 1004(b)(1) and (2) in 10 CFR 20.1004, “Units of radiation dose,” address the Q values 

25 for alpha and neutrons. 

26 1.2 Types of Licenses 

27 Specific Medical Use License

28 The NRC defines “medical use” as “the intentional internal or external administration of 

29 byproduct material, or the radiation from byproduct material, to patients or human research 

30 subjects under the supervision of an authorized user” (10 CFR 35.2, “Definitions”). An 

31 “authorized user” is defined as “a physician, dentist, or podiatrist” who meets the training and 

32 experience requirements specified in the board certification pathway in the applicable sections 

33 of 10 CFR Part 35 or who is identified as an AU (i) on an NRC or Agreement State license, 

34 (ii) on a permit issued by an NRC master materials licensee or an NRC master materials broad 

35 scope permittee that is authorized to permit the medical use of byproduct material, or (iii) on a 

36 permit issued by an NRC or Agreement State broad scope licensee authorized to permit the 

37 medical use of byproduct material (10 CFR 35.2). 

38 The NRC issues two types of specific licenses for the medical use of byproduct material in 

39 medical practices and facilities: 
1-7 

1  the specific license of limited scope (see Section 1.2.1) 

2  the specific license of broad scope (see Section 1.2.2) 

3 Medical use includes research involving human subjects, which may occur under either limited 

4 scope or broad scope specific licenses (see Section 1.2.3). 

5 Although the NRC usually issues a single byproduct materials license to cover an entire 

6 radionuclide program, the NRC may issue separate licenses to individual licensees for different 

7 medical uses. The NRC does not usually issue separate licenses to different departments in a 

8 medical facility or to individuals employed by a medical facility or with whom the medical facility 

9 has contracted. Only the facility’s management may sign the license application. 

10 General Laboratory License 

11 The NRC also issues a general license, pursuant to 10 CFR 31.11, under which a physician, 

12 veterinarian in the practice of veterinary medicine, clinical laboratory, or hospital may use 

13 byproduct material for certain in vitro clinical or laboratory testing. Such testing does not involve 

14 internal or external administration of byproduct material, or the radiation therefrom, to human 

15 beings or animals (see Section 1.2.4). 

16 Overview 

17 Applicants should study this report, related guidance, and all applicable regulations carefully 

18 before completing NRC Form 313 and the NRC Form 313A series of forms. The NRC expects 

19 licensees to provide information on specific aspects of the proposed radiation protection 

20 program in attachments to NRC Form 313. When necessary, the NRC may ask the applicant 

21 for additional information in order to gain reasonable assurance that an adequate radiation 

22 protection program has been established. 

23 After a license is issued, the licensee must conduct its program in accordance with 

24 the following: 

25  statements, representations, and procedures contained in the application and in 

26 correspondence with the NRC, when incorporated into a license by reference 

27  terms and conditions of the license 

28  NRC regulations 

29 In 10 CFR 30.9, “Completeness and Accuracy of Information,” the NRC requires that the 

30 information in the application be complete and accurate in all material aspects. This includes 

31 preceptor attestations for training and experience for authorized individuals, as described in 

32 IN-2007-38, “Ensuring Complete and Accurate Information in the Documentation of Training and 

33 Experience for Individuals Seeking Approval as Medical Authorized Users,” December 14, 2007. 

34 Information is considered material if it has the ability to change or affect an agency decision on 

35 issuing the license. 

36 1.2.1 Specific License of Limited Scope 

37 The NRC issues specific medical licenses of limited scope to private or group medical practices 

38 and to medical institutions. A medical institution is an organization in which more than one 
1-8 

1 medical discipline is practiced. In general, individual physicians or physician groups located 

2 within a licensed medical facility (e.g., hospital) may not apply for a separate license, because 

3 10 CFR 30.33(a)(2) refers to the applicant’s facilities. Since a physicians’ group does not 

4 normally have control over the facilities, the hospital remains responsible for activities 

5 conducted on its premises and must apply for the license. On specific licenses of limited scope, 

6 the authorized users are specifically listed in the license. 

7 Byproduct material may be administered to patients on an inpatient (i.e., hospitalized) or 

8 outpatient basis. For patients to whom byproduct material is administered and who are not 

9 releasable under 10 CFR 35.75, “Release of individuals containing unsealed byproduct material 

10 or implants containing byproduct material,” inpatient facilities are required. In general, facilities 

11 for private and group practices do not include inpatient rooms; therefore, procedures requiring 

12 hospitalization of the patient under 10 CFR 35.75 cannot be performed. 

13 A specific license of limited scope may also be issued to an entity requesting authorization to 

14 perform mobile medical services (10 CFR 35.80, “Provision of a Mobile Medical Service;” 

15 10 CFR 35.647 “Additional Technical Requirements for Mobile Remote Afterloader Units”). 

16 A medical institution or a private or group practice may apply for authorization to use byproduct 

17 material in a mobile medical service. 

18 1.2.2 Specific License of Broad Scope 

19 Medical institutions that provide patient care and conduct research programs that use 

20 radionuclides for in vitro, animal, and medical procedures may request a specific license of 

21 broad scope in accordance with 10 CFR Part 33. No medical use of byproduct material, 

22 including research involving human subjects, may be conducted without an authorization in a 

23 license from the NRC or an Agreement State, as provided in 10 CFR Part 35. The criteria for 

24 the various types of broad scope licenses are found in 10 CFR 33.13 through 10 CFR 33.17. 

25 Generally, the NRC issues specific licenses of broad scope for medical use (i.e., licenses 

26 authorizing multiple quantities and types of byproduct material for medical use under Part 35, as 

27 well as other uses) to institutions that (i) have experience successfully operating under a 

28 specific license of limited scope and (ii) are engaged in medical research and routine diagnostic 

29 and therapeutic uses of byproduct material. NUREG–1556, Volume 11, “Consolidated 

30 Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad 

31 Scope,” offers additional guidance to applicants for a specific license of broad scope. 

32 1.2.3 Research Involving Human Subjects 

33 In 10 CFR 35.2, the definition of “medical use” includes the administration of byproduct material 

34 or radiation therefrom to human research subjects. Furthermore, 10 CFR 35.6, “Provisions for 

35 the protection of human research subjects,” addresses the protection of the rights of human 

36 subjects involved in research by medical use licensees. For these licensees, prior NRC 

37 approval is not necessary if the research is conducted, funded, supported, or regulated by 

38 another Federal Agency that has implemented the Federal Policy for the Protection of Human 

39 Subjects. Otherwise, the licensee must apply for a specific amendment and receive approval 

40 for the amendment before conducting such research. Whether or not a license amendment is 

41 required, licensees must obtain informed consent from human subjects and prior review and 

42 approval of the research activities by an Institutional Review Board, in accordance with the 

43 meaning of those terms under the Federal Policy. In accordance with 10 CFR 35.6(a), research 

44 involving human subjects shall be conducted only with byproduct materials listed in the license 

45 for the uses authorized in the license. IN 2000-19, “Implementation of Human Research 
1-9 

1 Protocols Involving U.S. Nuclear Regulatory Commission Regulated Materials,” 

2 December 5, 2000, reminds licensees that 10 CFR 35.6 is not a blanket authority to conduct 

3 research involving human subjects, and compliance with all regulatory requirements and license 

4 conditions is necessary. 

5 1.2.4 General In Vitro License 

6 In 10 CFR 31.11, “General license for use of byproduct material for certain in vitro clinical or 

7 laboratory testing,” NRC establishes a general license authorizing physicians, veterinarians, 

8 clinical laboratories, and hospitals to receive, acquire, possess, or use small quantities of certain 

9 byproduct material for in vitro clinical or laboratory tests not involving “medical use” (i.e., not 

10 involving administration to humans). 10 CFR 31.11 explains the requirements for using the 

11 materials listed. If the general license alone meets the applicant’s needs, only NRC Form 483, 

12 “Registration Certificate – In Vitro Testing With Byproduct Material Under General License,” 

13 needs to be filed. Medical use licensees authorized under 10 CFR Part 35 do not need to file 

14 the form. 

15 The NRC limits possession to a total of 200 microcuries (μCi) [7.4 megabecquerels (MBq)] of 

16 photon-emitting materials listed in 10 CFR 31.11 at any one time, at any one location of storage 

17 or use. The use of materials listed in 10 CFR 31.11 within the inventory limits of that section is 

18 subject only to the requirements of that section and not the requirements of 10 CFR Parts 19, 

19 20, and 21, except as set forth in 10 CFR 31.11. 

20 An applicant needing more than 200 μCi [7.4 MBq] of these materials must apply for a specific 

21 license and may request the increased inventory limit as a separate line item on NRC Form 313. 

22 This type of applicant generally requests an increased limit of 3 millicuries [111 MBq]. If 

23 requesting an increased inventory limit, the applicant will be subject to the requirements of 

24 10 CFR Parts 19, 20, and 21, including the requirements for waste disposal. 

25 1.3 Other Requirements 

26 1.3.1 The “As-Low-As-Reasonably-Achievable (ALARA) Concept 

27 In 10 CFR 20.1101, “Radiation protection programs,” regulations state that “each licensee shall 

28 develop, document, and implement a radiation protection program commensurate with the 

29 scope and extent of licensed activities...” and “the licensee shall use, to the extent practical, 

30 procedures and engineering controls based upon sound radiation protection principles to 

31 achieve occupational doses and doses to members of the public that are...ALARA.” This 

32 section also requires that licensees review the content of the radiation protection program and 

33 its implementation at least annually. The RSO is responsible for the day-to-day operation of the 

34 radiation protection program. 

35 References and Resources: Applicants should consider the ALARA philosophy detailed in the 

36 following reports when developing plans to work with licensed radioactive materials. The 

37 following documents and resources contain information, methods, and references useful to 

38 
1-10 

1 those who are establishing radiation protection programs to maintain radiation exposures at 

2 ALARA levels in medical facilities: 

3  Regulatory Guide (RG) 8.10, “Operating Philosophy for Maintaining Occupational 

4 Radiation Exposures ALARA,” September 1975. 

5  RG 8.29, “Instruction Concerning Risks from Occupational Radiation Exposure,” 

6 February 1996. 

7  RG 8.18, “Information Relevant to Ensuring that Occupational Radiation Exposures at 

8 Medical Institutions Will Be ALARA,” April 2011. 

9  NUREG–1736, “Consolidated Guidance: 10 CFR Part 20 – Standards for Protection 

10 Against Radiation,” contains information directly related to radiation protection standards 

11 in 10 CFR Part 20. 

12  National Council on Radiation Protection and Measurements (NCRP) Report No. 107, 

13 “Implementation of the Principle of As Low As Reasonably Achievable (ALARA) for 

14 Medical and Dental Personnel,” December 31, 1990. 

15  NCRP Report No. 127, “Operational Radiation Safety Program,” 1998. 

16 WRITTEN DIRECTIVE PROCEDURES 

17 In 10 CFR 35.41, “Procedures for administrations requiring a written directive,” certain medical 

18 use licensees are required to develop, implement, and maintain written procedures to provide 

19 high confidence that before each administration requiring a WD, the patient’s identity is verified, 

20 and the administration is in accordance with the WD. This regulation also specifies what an 

21 applicant must, at a minimum, address in these procedures. Appendix S of this NUREG 

22 provides further information on developing these procedures. 

23 1.3.2 Office of Management and Budget (OMB) Clearances 

24 The information collection requirements in 10 CFR Parts 30 and 35, NRC Form 313, and the 

25 NRC Form 313A series of forms have been approved under the OMB Clearance Numbers 

26 3150-0017, 3150-0010, and 3150-0120, respectively.
2-1 

1 2 AGREEMENT STATES 

2 2.1 Jurisdiction Determination 

3 Certain States, called Agreement States (see Figure 2-1), have 

4 entered into agreements with the U.S. Nuclear Regulatory 

5 Commission (NRC) that give them the authority to license and inspect 

6 byproduct, source, and special nuclear materials, in quantities not 

7 sufficient to form a critical mass, which are used or possessed within 

8 their borders. Any applicant, other than a Federal entity, who wishes 

9 to possess or use licensed material in one of these Agreement States 

10 should contact the responsible officials in that State for guidance on preparing an application. 

11 These applications should be filed with State officials, not with the NRC. In areas under 

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

13 regulatory authority. 

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

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

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

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
2-2 

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

recognized Indian tribes.2 2 

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

4 while the Agreement State has jurisdiction over nonexclusive Federal jurisdiction land. 

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

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

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

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

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

10 regulatory authority. 

Table 2-1. Who Regulates the Activity? 

Applicant and Proposed Location of Work Regulatory Agency 

Federal agency regardless of location (except that the 

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

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

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

byproduct material under certain U.S. Department of Energy and 

U.S. 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 

Non-Federal entity in Agreement State Agreement State4

 

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 

http://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. 

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. 
2-3 

Table 2-1. Who Regulates the Activity? 

Applicant and Proposed Location of Work Regulatory Agency 

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

subject to exclusive Federal jurisdiction 

Agreement State4

Non-Federal entity in Agreement State at federally controlled site 

subject to exclusive Federal jurisdiction 

NRC 

Non-Federal entity in Agreement State using radioactive materials 

(except industrial radiography) directly connected with 10 CFR 

Part 50 or 52 reactor operations or needed during the construction 

and preoperational phases of a reactor. 

NRC 

Non-Federal entity in Agreement State using radioactive materials 

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

or needed during the construction and preoperational phases of a 

reactor. 

Agreement State4

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

2 numbers of responsible officials) is available on the NMSS Directory of Agreement State and 

3 Non-Agreement State Directors and State Liaison Officers. A request for the list can also be 

4 made to an NRC regional office. 

5 2.2 Reciprocal Recognition of Specific Licenses 

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

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

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

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

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

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

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

13 in advance of the scheduled use of licensed material. 

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

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

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

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

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

19 be renewed annually. 

20 Specific guidance regarding NRC licensees filing for reciprocity in Agreements States and 

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

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

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

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

25 Offshore Waters’ and ‘Guidance for NRC Licensees Proposing to Work in Agreement State 

26 Jurisdiction (Reciprocity).’”

3-1 

1 3 MANAGEMENT RESPONSIBILITY 

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

3 effective radiation safety program management is vital for achieving 

4 safe, secure, and compliant operations. Consistent compliance with 

5 NRC regulations provides reasonable assurance that licensed 

6 activities will be conducted safely and that effective management will 

7 result in increased safety, security, and compliance. See Title 10 of 

8 the Code of Federal Regulations (10 CFR) 35.24, “Authority and 

9 responsibilities for the radiation protection program.” 

10 3.1 Commitments and Responsibilities 

11 To ensure adequate management involvement in accordance with 10 CFR 35.12(a), 

12 “Application for license, amendment, or renewal,” and 35.24(a), a management representative 

13 (i.e., chief executive officer or delegate) must sign the submitted application. If it is not clear 

14 whether the application was signed by someone duly authorized to act for and on behalf of the 

15 applicant or licensee, NRC license reviewers may ask for additional assurances that the 

16 individual who signed the application is duly authorized to act for and on behalf of the applicant 

17 or licensee. The signature on an application acknowledges the licensee’s commitments and 

18 responsibility for the following: 

19  Radiation safety, security, and control of radioactive materials and compliance 

20 with regulations. 

21  Completeness and accuracy of the radiation safety records and all information provided 

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

23  Knowledge about the contents of the license application. 

24  Compliance with current NRC and U.S. Department of Transportation regulations, the 

25 licensee’s operating, emergency, and security procedures, and NRC license 

26 commitments. 

27  Commitment to provide adequate financial and other resources (including space, 

28 equipment, personnel, time, and, if needed, contractors) to the radiation protection 

29 program to ensure that patients, the public, and workers are protected from radiation 

30 hazards and that compliance with regulations is maintained. 

31  Selection and assignment of a qualified individual to serve as the radiation safety officer 

32 (RSO), who agrees, in writing, to be responsible for implementing the radiation 

33 protection program. The RSO shall have independent authority to stop unsafe 

34 operations and will be given sufficient time to fulfill radiation safety duties 

35 and responsibilities. 

36  Commitment to ensure that radiation workers have adequate training. 

Part 35 Applicability

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“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. 
3-2 

1  Prevention of discrimination against employees engaged in protected activities 

2 (10 CFR 30.7, “Employee protection”). 

3  Commitment to provide information to employees regarding the employee protection and 

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

5 10 CFR 30.10, “Deliberate misconduct.” 

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

7 license (see Section 9.2.1, “Transfer of Control,” of this NUREG.) 

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

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

10 as discussed further in Section 9.2.2, “Notification of Bankruptcy Proceedings,” of this 

11 NUREG. 

12  Approval of qualified individual(s) to serve as authorized medical physicists, authorized 

13 nuclear pharmacist, and authorized users for licensed activities. 

14 For information on inspection, investigation, enforcement, and other compliance programs, see 

15 a description of the NRC’s Enforcement process at NRC Enforcement Policy and the NRC’s 

16 Inspection Procedures found on the Medical Uses Licensee Toolkit. 

17 3.2 Safety Culture 

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

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

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

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

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

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

24 subject to NRC authority. 

25 “Nuclear safety culture” is defined in the NRC’s Safety Culture Policy Statement (76 FR 34773; 

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

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

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

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

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

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

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

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

34 from NRC’s Safety Culture Policy Statement. 

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

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

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

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

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

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

41 thus, mechanisms should be established to identify and resolve these differences. A safety 
3-3 

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

2 with NRC-regulated activities. 

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

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

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

6 Safety Culture Policy Statement and traits are not incorporated into the regulations. Many of the 

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

8 programs. For instance, time-outs before a therapeutic procedure may provide an opportunity 

9 for the medical team to double-check treatment parameters and the WD to reduce the likelihood 

10 of a medical event. The use of time-outs may correspond with the safety culture trait “Work 

11 Processes” (the process of planning and controlling work activities is implemented so that safety 

12 is maintained) (Table 3-1). However, licensees should be aware that this is just an example 

13 and should consider reviewing their radiation safety programs in order to develop and 

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

15 and functions. 

16 Refer to Appendix A of this NUREG for the NRC’s Safety Culture Policy Statement. 

17 More information on NRC activities relating to safety culture can be found on the 

18 NRC Safety Culture Web site. 

 

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. 
3-4 

Table 3-1. Traits of a Positive Safety Culture 

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 

3 available up-to-date copies of applicable regulations, to read and 

4 understand the requirements of each of these regulations, and to 

5 comply with each applicable regulation. The following parts of 

6 Title 10 of the Code of Federal Regulations (CFR) contain regulations 

7 applicable to licensing medical use of byproduct material. materials. 

8 Some of these parts are specific to one type of license, while others 

9 are general and will apply to many, if not all, licensees. 

10 The current versions of the following parts can be found online in the 

11 U.S. Nuclear Regulatory Commission (NRC) library using the links 

12 provided: 

13  10 CFR Part 2 “Agency Rules of Practice and Procedure” 

14  10 CFR Part 19 “Notices, Instructions, and Reports to Workers: Inspection 

15 and Investigations” 

16  10 CFR Part 20 “Standards for Protection Against Radiation” 

17  10 CFR Part 21 “Reporting of Defects and Noncompliance” 

18  10 CFR Part 30 “Rules of General Applicability to Domestic Licensing of 

19 Byproduct Material” 

20  10 CFR Part 31 “General Domestic Licenses for Byproduct Material” 

21  10 CFR Part 32 “Specific Domestic Licenses to Manufacture or Transfer Certain 

22 Items Containing Byproduct Material” 

23  10 CFR Part 33 “Specific Domestic Licenses of Broad Scope for 

24 Byproduct Material” 

25  10 CFR Part 35 “Medical Use of Byproduct Material” 

26  10 CFR Part 37 “Physical Protection of Category 1 and Category 2 Quantities of 

27 Radioactive Material 

28  10 CFR Part 40 “Domestic Licensing of Source Material” 

29  10 CFR Part 71 “Packaging and Transportation of Radioactive Material” 

30  10 CFR Part 150 “Exemptions and Continued Regulatory Authority in Agreement 

31 States and in Offshore Waters Under Section 274” 

32  10 CFR Part 170 “Fees for Facilities, Materials, Import and Export Licenses, and 

33 Other Regulatory Services Under the Atomic Energy Act of 1954, 

34 as Amended” 

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

2 Materials Licenses, Including Holders of Certificates of 

3 Compliance, Registrations, and Quality Assurance Program 

4 Approvals and Government Agencies Licensed by the NRC” 

5 Copies of these documents may be obtained by calling the Government Printing Office 

6 Customer Contact Center toll-free at (866) 512-1800, or in Washington, DC; calling 

7 (202) 512-1800; or online at the U.S. Government Bookstore. 

8 NRC regulations can also be accessed on the NRC Regulations Web site. Regulations are 

9 periodically amended, and the NRC (as well as all other Federal agencies) is required to publish 

10 notice of such amendments in the Federal Register.
5-1 

1 5 HOW TO FILE 

2 5.1 Application Preparation 

3 Applicants for a materials license should do the following: 

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

5  Complete U.S. Nuclear Regulatory Commission (NRC) 

6 Form 313 (Appendix B of this NUREG), Items 1 through 4, 

7 12, and 13 on the form itself. 

8  Complete NRC Form 313, Items 5 through 11, on 

9 supplementary pages, or use Appendix C of this NUREG. 

10  Complete the appropriate NRC Form 313A series (Appendix E of this NUREG) of forms 

11 to document training and experience. 

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

13 experience, and the radiation safety program are adequate to protect health and safety 

14 and minimize danger to life and property. 

15  For each separate sheet other than the NRC Forms 313 and 313A series (Appendix B 

16 and Appendix E of this NUREG) or Appendix C of this NUREG submitted with the 

17 application, identify and cross-reference submitted information to the item number on the 

18 application or the topic to which it refers. 

19  Avoid submitting proprietary information and personally identifiable information. 

20  If submitted, proprietary information and other sensitive information (e.g., personal 

21 privacy and security related) should be clearly identified in accordance with Title 10 of 

22 the Code of Federal Regulations (CFR) 10 CFR 2.390, “Public inspections, 

23 exemptions, and requests for withholding.” (See Chapter 6, “Identifying and Protecting 

24 Sensitive Information.”) 

25 5.2 Where to File 

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

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

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

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

30 States. Section 8.10.17, “Mobile Medical Service,” and Appendix V of this NUREG provide 

31 further information on filing procedures for applicants who wish to perform mobile medical 

32 services. Note that all materials license applications are submitted to Regions I, III, or IV. All 

33 applicants for materials licenses located in the Region II geographical area should send their 

34 applications to Region I. 

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

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

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

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

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

3 States,” for additional information. 

4 5.3 Paper Applications 

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

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

7 applicants should do the following: 

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

9 into a document scanner. 

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

11 (the text of this document is in the Arial font). 

12  Use 11-point or larger font. 

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

14  Ensure that the print is clear and sharp. 

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

16 is best). 

17 5.4 Electronic Applications 

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

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

20 the NRC’s e-submittal Web site. The guidance discusses, among other topics, the formats the 

21 NRC can accept, the use of electronic signatures, and the treatment of non-public information. 

Applications must be signed by the applicant’s or licensee’s management, as required by 

10 CFR 35.12(a). (See Section 8.13, “Certification.”) 
6-1 

1 6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION 

2 All licensing applications, except for portions containing sensitive 

3 information, will be made available for review in the U.S. Nuclear 

4 Regulatory Commission’s (NRC’s) Public Document Room and 

5 electronically at the NRC Library. 

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

7 information against unauthorized disclosure to the public. License 

8 applications that contain sensitive information should be marked, as 

9 indicated below, in accordance with Title 10 of the Code of Federal 

10 Regulations (CFR) 10 CFR 2.390 before the information is submitted 

11 to the NRC. Key examples are as follows: 

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

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

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

15 substantial delays in processing the application. Appendix F includes a checklist for 

16 requests for withholding information from public disclosure. 

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

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

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

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

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

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

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

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

25 U.S. Nuclear Regulatory Commission,” dated March 9, 2007, and Information Notice 

26 2013-22, “Recent Licensing Submittals Containing Personally Identifiable Information,” 

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

28 Web page. 

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

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

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

32 certain 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 security-related sensitive information and the top of 

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

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

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

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

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

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

43 Byproduct, and Special Nuclear Material,” December 22, 2005. Additional information 

44 on procedures and any updates are available in the NRC Library on the Witholding of 

45 Sensitive Information page. 

Part 35 Applicability

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6-2 

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

2 These include: 

3 • trade secrets and commercial or financial information 

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

5 party other than an agency in litigation with NRC 

6 • certain records or information compiled for law enforcement purposes 

7 • geological and geophysical information and data, including maps, or information 

8 concerning wells 

9 • personnel, medical, and other information, the disclosure of which would constitute a 

10 clearly unwarranted invasion of personal privacy 

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

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

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

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

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

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

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

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

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

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

21 proprietary status of the information. 

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

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

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

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

3 by the appropriate fee. Refer to Title 10 of the Code of Federal 

4 Regulations (CFR) 10 CFR 170.31, “Schedule of fees for materials 

5 licenses and other regulatory services, including inspections, and 

6 import and export licenses,” to determine the amount of the fee. The 

7 U.S. Nuclear Regulatory Commission (NRC) will not issue a license 

8 until the fee is received. Consult 10 CFR 170.11, “Exemptions,” for 

9 information on exemptions from these fees. Once the technical 

10 review of an application has begun, no fees will be refunded. 

11 Application fees will be charged regardless of the NRC’s disposition 

12 of an application or the withdrawal of an application. 

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

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

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

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

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

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

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

20 Direct all questions about the NRC’s fees or completion of Item 12 of NRC Form 313 by calling 

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

22 301-415-7554. Information about fees may also be obtained by calling NRC’s toll-free number, 

23 800-368-5642, extension 415-7554. The e-mail address is Fees.Resource@nrc.gov. 

Part 35 Applicability

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8-1 

1 8 CONTENTS OF AN APPLICATION 

2 This chapter explains, item by item, the information that medical use applicants must provide on 

3 U.S. Nuclear Regulatory Commission (NRC) Form 313 and should provide on the appropriate 

4 NRC Form 313A series of forms, if electing to use these optional forms. See Appendix D of this 

5 NUREG for details on how to complete the NRC Form 313A series of forms. 

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

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

8 program satisfy regulatory requirements and are adequate to protect public health and safety 

9 and minimize danger to life and property. Consideration should be given when developing the 

10 application to the concepts of keeping exposure as low as is reasonably achievable (ALARA), 

11 minimizing contamination, and maintaining control of radioactive materials. 

12 Title 10 of the Code of Federal Regulations (CFR) 10 CFR 20.1101(b) states: “The licensee 

13 shall use, to the extent practical, procedures and engineering controls based upon sound 

14 radiation protection principles to achieve occupational doses and doses to members of the 

15 public that are as low as is reasonably achievable (ALARA).” Regulatory Guide (RG) 8.10, 

16 Revision 2, “Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as 

17 Is Reasonably Achievable,” discusses the ALARA concept and philosophy. The application 

18 should document ALARA considerations, including establishing administrative action levels and 

19 monitoring programs. 

20 10 CFR 20.1406, “Minimization of contamination,” requires applicants for licenses to describe 

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

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

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

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

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

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

27 material not in storage.” 

28 If an application contains security-related sensitive information, the cover letter should state that 

29 the “attached documents contain security-related sensitive information.” See Chapter 6, 

30 “Identifying and Protecting Sensitive Information,” for more instructions on marking sensitive 

31 documents submitted to the NRC. If a cover letter is not used, NRC Form 313 should include 

32 this statement. The information needed to complete Items 5 through 11 on Form 313 describes 

33 the applicant’s proposed medical use radiation safety program. To assist the applicant in 

34 submitting complete information on these items, the applicable regulations are referenced in the 

35 discussion of each item. 

36 Tables C–1 and C–2 in Appendix C of this NUREG are provided to help applicants submit 

37 information required to complete Items 5 through 11 of NRC Form 313. Lengthy responses and 

38 supplemental information should be appended as attachments. 

39 Table C–3 in Appendix C of this NUREG is provided to help applicants determine which 

40 procedures must be developed, implemented, and maintained for the type of medical use 

41 requested. Several appendices in this report present sample procedures that applicants may 

42 use in developing their procedures. Suggested responses for each block on the NRC Form 313 

43 appear under “Response from Applicant” in this guide. 
8-2 

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

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

3 8.1 Item 1: License Action Type 

4 Item 1 of NRC Form 313 states the following: 

5 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 

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

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

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

9 issuance of the license. 

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

11 Check box C for a renewal of an existing license, and provide the license number. 

12 See Chapter 9, “License Amendments and Renewals,” of this report.

13 8.2 Item 2: Name and Mailing Address of Applicant 

14 Regulations: 10 CFR 35.12

15 List the legal name of the applicant’s corporation or other legal entity 

16 with direct control over use of the radioactive material. A division or 

17 department within a legal entity may not be a licensee. An individual 

18 may be designated as the applicant only if the individual is acting in a 

19 private capacity and the use of the radioactive material is not 

20 connected with employment in a corporation or other legal entity. 

21 Provide the mailing address where correspondence should be sent. 

22 A post office box number is an acceptable mailing address. 

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

24 See Section 8.13, “Certification” for proper signature of NRC forms. 

Applicants must submit NRC Form 313 to apply for a license. Applicants may use the 

appropriate NRC Form 313A series of forms to document training and experience for new 

authorized users (AU), authorized medical physicists (AMP), authorized nuclear pharmacists 

(ANP), and radiation safety officers (RSO). Applicants may use Tables C–1 and 2 in 

Appendix C of this NUREG to assist with completion of the application. 

Part 35 Applicability

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Part 35 Applicability

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8-3 

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

2 transferred (see Section 9.2.1, “Transfer of Control”). The NRC must also be notified when 

3 bankruptcy proceedings have been initiated (see Section 9.2.2, “Notification of Bankruptcy 

4 Proceedings”). Guidance on information to be supplied to the NRC is available in 

5 NUREG–1556, Volume 15, “Program-Specific Guidance About Changes of Control and About 

6 Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses,” and 

7 Regulatory Issue Summary (RIS) 2014-08, “Regulatory Requirements for Transfer of Control 

8 (Change of Ownership) of Specific Materials Licenses,” May 27, 2014.

9 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or 

10 Possessed 

11 Regulations: 10 CFR 30.33(a)(2), 10 CFR 30.34(c), 10 CFR 35.12

12 Specify the street address, city, and State or other descriptive 

13 address (e.g., on Highway 10, 5 miles east of the intersection of 

14 Highway 10 and State Route 234, Anytown, State) for each facility at 

15 which licensed material will be used or stored. The descriptive 

16 address should be sufficient to allow an NRC inspector to find the 

17 facility location. A post office box address is not acceptable. 

18 See Figure 8-1 below. 

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 

19 If byproduct material is to be used at more than one location under the license, the specific 

20 address (e.g., street and building) must be provided for each facility. If applying for a license for 

21 mobile medical services, as authorized pursuant to 10 CFR 35.18(b), the applicant should refer 

RPh17a.ppt

082898

32 Elm St.

City, ST 12345 P.O. Box XXXX

City, ST 12345

32 ELM St.

Part 35 Applicability

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8-4 

1 to Section 8.10.17 “Mobile Medical Service,” and Appendix V of this NUREG for specific 

2 licensing guidance. For additional addresses where licensed material will be used or 

3 possessed, an amendment must be approved. 

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

5 address or location not already listed on the license. 

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

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

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

9 Protecting Sensitive Information,” for more details. 

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

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

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

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

14 is terminated). For medical use licensees, acceptable records include sketches and written 

15 descriptions of the specific locations where material is (or was) used or stored and any records 

16 of leaking radioactive sources, spills (e.g., where contamination remains after cleanup 

17 procedures or when there is reasonable likelihood that contaminants may have spread), 

18 damaged devices, or other unusual occurrences involving the possible spread of contamination 

19 in or around the licensee’s facilities. 

20 8.4 Item 4: Person To Be Contacted About This Application 

21 Identify the individual who can answer questions about the 

22 application, and include a telephone number where the individual 

23 may be contacted. Also include business cell phone numbers and e24 mail addresses. 

25 Note: Contact information provided should not contain Personally 

26 Identifiable Information (PII) (e.g., home telephone number, personal 

27 cellular telephone number, or home email address). For additional 

28 information on PII, see Chapter 6, “Identifying and Protecting 

29 Sensitive Information.” 

30 This individual, usually the RSO, will serve as the point of contact during the review of the 

31 application. If this individual is not a full-time employee of the licensed entity, his or her position 

32 and relationship to the licensee should be specified. The NRC should be notified if the person 

33 assigned to this function changes or if his or her telephone number, cell phone number, or 

34 e-mail address changes. Notification of a contact change is only provided for informational 

35 purposes and would not be considered an application for license amendment, unless the 

36 notification involves a change in the contact person who is also the RSO. 

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

be submitted on separate sheets of paper. Applicants may use Appendix C 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 report will facilitate the NRC’s review. 

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

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

Part 35 Applicability

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1 The individual named in Item 4 may or may not be the same individual who signs the application 

2 as the “certifying officer” on behalf of the licensee with the authority to make commitments to the 

3 NRC. (See Item 13 on NRC Form 313). 

4 The NRC recognizes that licensees may contract with a consultant or consultant group to help 

5 prepare the license application and provide support to the radiation protection program. 

6 However, the NRC reminds licensees that regardless of the role of the consultant in radiation 

7 protection program management, the licensee remains responsible for all aspects of the 

8 licensed program, including the services performed by the consultant.

9 8.5 Item 5: Radioactive Material 

10 8.5.1 Byproduct Material and Depleted Uranium 

11 Regulations: 10 CFR 20.2207, 10 CFR 30.32, 10 CFR 31.11, 

12 10 CFR 32.210, 10 CFR 35.65, 10 CFR 35.100, 10 CFR 35.200, 

13 10 CFR 35.300, 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, 

14 10 CFR 35.1000, 10 CFR Part 37, 10 CFR 40.4

15 Criteria: Byproduct material for medical use in 10 CFR Part 35 is 

16 divided into seven types of use: 10 CFR 35.100, 35.200, 35.300, 

17 35.400, 35.500, 35.600, and 35.1000. Depleted uranium is used in 

18 shielding and collimation in medical devices. Licensees must also 

19 protect aggregated Category 1 and Category 2 quantities of 

20 radioactive material, as defined in 10 CFR 37.5, from theft, diversion, and sabotage. 

21 Discussion: The applicant should indicate the byproduct material requested. Specifically, 

22 NRC Form 313 requests element and mass number, chemical and/or physical form, and the 

23 maximum amount that will be possessed at any one time. The applicant should refer to 

24 Table C–1 of Appendix C of this NUREG for an acceptable format for describing the radioactive 

25 material. The amount and type of information necessary will vary according to the type of use 

26 and material requested. 

27 35.100 and 35.200 Use: The chemical/physical form may be “Any” unsealed byproduct 

28 material permitted by 10 CFR 35.100 or 35.200, as appropriate. The total amount requested 

29 may be “As Needed.” 

30 35.300 Use: The chemical/physical form may be “Any” unsealed byproduct material permitted 

31 by 10 CFR 35.300. The total amount requested must be specified. Table C–1 of Appendix C of 

32 this NUREG provides examples, if only one radionuclide is used. 

33 35.400, 35.500, 35.600 Use: The radionuclide; the chemical/physical form (e.g., sealed source 

34 or device identified by manufacturer and model number); the activity per source and the total 

35 activity in becquerels (Bq), microcuries (μCi), millicuries (mCi), or curies (Ci), including 

36 replacement sources; and the maximum number of sources or activity possessed at any 

37 one time must be specified. Applicants should include all possible alternate source models 

38 they might use in order to minimize the need for license amendments if they change model 

39 or vendor. 

Part 35 Applicability

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8-6 

1 For therapy devices, the applicant must consider the shipped, installed, and medical use 

2 limitations on activity. Limitations are described in the Sealed Source and Device (SSD) 

3 registration certificates and U.S. Food and Drug Administration (FDA) 510k certificates. 

4 Gamma stereotactic radiosurgery (GSR) and teletherapy sources are usually at or above 

5 Category 1 quantities, and co-located high dose-rate (HDR) brachytherapy sources are usually 

6 at or above Category 2 quantities. The applicant should also review NUREG–2155,

7 “Implementation Guidance for 10 CFR Part 37, ‘Physical Protection of Category 1 and 

8 Category 2 Quantities of Radioactive Material,’” January 2015 and NUREG–2166, “Physical 

9 Security Best Practices for the Protection of Risk-Significant Radioactive Material,” May 2014, 

10 for additional guidance implementing 10 CFR Part 37 requirements for these therapy devices. 

11 Applicant information on manufacturers, model numbers, and possession limits is sensitive and 

12 should be marked accordingly. See Chapter 6, “Identifying and Protecting Sensitive 

13 Information.” Category 1 and Category 2 sources regulated by the NRC and Agreement States 

14 must be tracked in the National Source Tracking System (NSTS). 

15 For 35.1000 Use: The radionuclide, the chemical/physical form, and the total amount must be 

16 specified. Applicants should refer to the Medical Uses Licensee Toolkit and consult with the 

17 appropriate NRC Regional Office to discuss the contents of the application. 

18 Calibration, Transmission, and Reference Sources: For all calibration, transmission, and 

19 reference sources covered under 10 CFR 35.65, the specific sources do not need to be listed 

20 on the license as long as the licensee is authorized pursuant to 10 CFR 35.11 for the medical 

21 use of byproduct material. However, if the quantity specified in 10 CFR 35.65 is exceeded, the 

22 specific sources need to be listed on the license. 

23 Shielding Material/Depleted Uranium: Some high-activity radionuclide generators used to 

24 produce byproduct materials for 10 CFR 35.200 and 35.300 uses [e.g., technetium-99m 

25 (Tc-99m) generators] may include depleted uranium [i.e., uranium depleted in uranium-235 

26 (U-235), as defined in 10 CFR 40.4] as shielding material. If a generator has depleted uranium 

27 shielding, an applicant should request authorization to possess depleted uranium as shielding 

28 material. Applicants receiving large therapy sources and devices also should determine if 

29 depleted uranium is used to shield or collimate the therapy sources and devices. This includes 

30 identifying depleted uranium used as shielding in linear accelerators because, even though the 

31 NRC does not regulate the accelerator, it does regulate the depleted uranium in the accelerator. 

32 If applicable, the applicant should request authorization to possess depleted uranium 

33 (i.e., uranium depleted in U-235) in quantities sufficient to include shielding material in both the 

34 device(s) and source containers used for source exchange and shielding for other devices. The 

35 applicant should review the manufacturer’s specifications for each device specified in the 

36 license request to determine (i) if depleted uranium is used to shield the source(s) within the 

37 device and (ii) the total quantity of depleted uranium present in the device in kilograms. The 

38 applicant should also consult the manufacturer’s specifications or the source supplier to 

39 determine if depleted uranium is contained in shielding source containers used during source 

40 exchange, as well as the total quantity of depleted uranium in such containers in kilograms. 

41 Note: Most depleted uranium used for shielding or beam collimation in therapy devices is 

42 covered under a general license, in accordance with 10 CFR 40.25. Applicants or licensees 

43 may either request to include the depleted uranium on the specific medical license or, as 

44 applicable, submit NRC Form 244, “Registration Certificate – Use of Depleted Uranium Under 

45 General License,” to register the material. 
8-7 

1 Sealed Sources and Devices: In accordance with 10 CFR 30.32(g), applicants must provide 

2 the manufacturer’s (or distributor’s) name and model number for each requested sealed source 

3 and device (except for calibration, transmission, and reference sources authorized by 

4 10 CFR 35.65, and certain Naturally-Occurring and Accelerator-Produced Radioactive Material 

5 (NARM) sources for which this information is not available). Licensees will be authorized to 

6 possess and use only those sealed sources and devices specifically approved or registered 

7 by the NRC or an Agreement State or when information required in 10 CFR 30.32(g)(3)

8 is provided. 

9 Applicants will need to request authorization for possession of these sealed source(s) or 

10 device(s). The NRC or an Agreement State performs a safety evaluation of sealed sources and 

11 devices before authorizing a manufacturer to distribute the sources or devices to specific 

12 licensees. The safety evaluation is documented in an SSD registration certificate issued to the 

13 manufacturer (or distributor). Prior to 2005, some non-Agreement States may also have 

14 performed similar safety evaluations for sealed sources and devices containing NARM, and 

15 these safety evaluations may be documented in SSD registration certificates. If the sealed 

16 source or device contains NARM material and was produced before the effective date of the 

17 rule, November 30, 2007, it may not have a SSD registration certificate and the information 

18 required by 10 CFR 32.210 may not be available. If this is the case, the applicant must provide 

19 the information required in 10 CFR 30.32(g)(3). For example, if a discrete source of radium-226 

20 (Ra-226) is requested, provide a complete description of the discrete source, including 

21 manufacturer, model number, activity, and intended use. If the source is not registered, include 

22 construction and testing of the sealed source, as described in 10 CFR 32.210(c). 

23 Sources that are authorized by 10 CFR 35.65, “Authorization for calibration, transmission, and 

24 reference sources,” should not be listed. However, calibration, transmission, and reference 

25 sources that do not meet the criteria or exceed the quantity in 10 CFR 35.65 should be 

26 specifically described. 

27 Consult with the proposed supplier or manufacturer to ensure that requested sources and 

28 devices are compatible with each other and that they conform to the SSD designations 

29 registered with the NRC or an Agreement State. Licensees may not use any changes to the 

30 sealed source, device, or source-device combination that would alter the description or 

31 specifications from those indicated in the respective SSD registration certificates without 

32 obtaining the NRC’s prior permission in a license amendment. Licensees providing information 

33 in accordance with the provisions of 10 CFR 30.32(g) may not make changes to the sealed 

34 sources, device, or source-device combination that would alter the description or specifications 

35 provided to the NRC without obtaining the NRC’s prior permission in a license amendment. To 

36 ensure that sealed sources and devices are used in ways that comply with the SSD registration 

37 certificates, applicants may want to review or discuss them with the manufacturer. The licensee 

38 or applicant should contact the manufacturer and distributor of the device for a copy of the SSD 

39 registration certificate. If the manufacturer and distributor is no longer in service, the licensee or 

40 applicant should contact the NRC or the issuing Agreement State for further guidance. In 

41 addition, the International Commission on Radiation Units and Measurements, “Certification of 

42 Standardized Radioactive Sources,” Report No. 12, 1968, contains useful information for 

43 standardizing activity measured in sources. 

44 Other Material: The applicant should make a separate entry for other required items 

45 (e.g., unsealed Ra-226 not previously described; more byproduct material for in vitro testing 

46 than is allowed under 10 CFR 31.11; radiation survey meter calibration source; dosimetry 

47 system constancy check source; material for in vitro, animal, or human research studies). 
8-8 

1 Sources that are authorized by 10 CFR 35.65 should not be listed. 

2 Blood Irradiators: If the use of a device to irradiate blood is anticipated, the applicant should 

3 review NUREG–1556, Volume 5, “Consolidated Guidance About Materials Licenses: 

4 Program-Specific Guidance About Self-Shielded Irradiator Licenses,” and submit information as 

5 applicable. The applicant should also review NUREG–2155, “Implementation Guidance for 

6 10 CFR Part 37, ‘Physical Protection of Category 1 and Category 2 Quantities of Radioactive 

7 Material,’” January 2015 and NUREG–2166, “Physical Security Best Practices for the Protection 

8 of Risk-Significant Radioactive Material,” May 2014, for additional guidance implementing 

9 10 CFR Part 37 requirements for blood irradiators. Applicant information on manufacturers, 

10 model numbers, and possession limits is sensitive and should be marked accordingly. See 

11 Chapter 6, “Identifying and Protecting Sensitive Information.” Category 1 and Category 2 

12 sources regulated by the NRC and Agreement States must be tracked in the NSTS. 

The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated “Category 1 

quantity of radioactive material” or “Category 2 quantity of radioactive material.” These terms 

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

are listed in Appendix A to 10 CFR Part 37. See Section 8.10.24, “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. 

13 

14 Production of Radionuclides by Accelerators: If the applicant will use an accelerator to 

15 produce radionuclides, a separate license application will be needed for the production of the 

16 radionuclides. The applicant should review NUREG–1556, Volume 21, “Consolidated Guidance 

17 About Materials Licenses: Program-Specific Guidance About Possession Licenses for 

18 Production of Radioactive Materials Using an Accelerator.” 

19 Production of PET Radioactive Drugs for Noncommercial Distribution to Medical Use 

20 Licensees Within a Consortium: If the applicant will produce Positron Emission Tomography 

21 (PET) radioactive drugs for its own medical use and noncommercial distribution to other 

22 members of its consortium, the applicant should review NUREG–1556, Volume 13, 

23 “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 

24 Commercial Radiopharmacy Licenses,” and NUREG–1556, Volume 21, “Consolidated 

25 Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses 

26 for Production of Radioactive Materials Using an Accelerator.” 

27 When applying for this authorization, the applicant should also consider applying for 

28 authorization to take back potentially contaminated transport shields from other consortium 

29 members. Each consortium member should dispose of unused dosages and used syringes and 

30 vials at its own facility. 

31 When determining both individual radionuclide and total quantities, all materials to be 

32 possessed at any one time under the license should be included [i.e., materials received 

33 awaiting use (e.g., new teletherapy or brachytherapy sources for exchange), materials in use or 

34 possessed, material used for shielding, and materials classified as waste awaiting disposal or 

35 held for decay-in-storage]. 

36 Response from Applicant: The applicant should submit the information as described above. 

37 When responding to this section, follow the guidance in Chapter 6, “Identifying and Protecting 

38 Sensitive Information,” to determine if the response includes security-related sensitive 

39 information and needs to be marked accordingly. 
8-9 

1 8.5.2 Financial Assurance and Recordkeeping for Decommissioning 

2 Regulations: 10 CFR 30.34(b), 10 CFR 30.35, 10 CFR 30.51

3 Criteria: Licensees authorized to possess licensed material with 

4 half-lives greater than 120 days and in excess of the limits specified 

5 in 10 CFR 30.35, “Financial assurance and recordkeeping for 

6 decommissioning,” must provide evidence of financial assurance for 

7 decommissioning. 

8 Licensees are required to maintain, in an identified location, 

9 decommissioning records related to structures and equipment where 

10 devices are used or stored, as well as records related to leaking 

11 sources. Pursuant to 10 CFR 30.35(g), licensees must transfer records important to 

12 decommissioning to new licensees before licensed activities are transferred or assigned, 

13 according to 10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 30.51(f), prior to license 

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

15 appropriate NRC regional office. 

Decommissioning records described above are not required for temporary jobsite locations. 

16 Discussion: All licensees are required, under 10 CFR 30.35(g), to maintain records important 

17 to decommissioning in an identified location. These records must, in part, identify all areas 

18 where licensed material is (or was) used or stored and any information relevant to spills 

19 (e.g., where contamination remains after cleanup procedures or when there is a reasonable 

20 likelihood that contaminants may have spread), leaking sealed sources, and contamination. As 

21 an alternative to the potential need for site characterizations, some licensees prefer to maintain 

22 information on surveys and leak tests on an ongoing basis and as a low-cost means of providing 

23 evidence and assurance of an appropriate decommissioning status upon the termination of 

24 licensed activities and/or release of a site for nonlicensed use. Pursuant to 10 CFR 30.35(g), 

25 licensees must transfer the records important to decommissioning to the new licensee before 

26 licensed activities are transferred or assigned, in accordance with 10 CFR 30.34(b), and must 

27 transfer records to the appropriate NRC Regional Office before the license is terminated, in 

28 accordance with 10 CFR 30.51. 

29 Licensees using sealed sources authorized by 10 CFR Part 35 generally use licensed material 

30 in a manner that would preclude releases into the environment, would not cause the activation 

31 of adjacent materials, or would not contaminate work areas. The licensee’s most recent leak 

32 tests should demonstrate that there has been no leakage from the sealed sources while the 

33 sealed sources were in the licensee’s possession. However, any leakage from sealed sources 

34 in excess of the regulatory limits would warrant further NRC review of decommissioning 

35 procedures on a case-by-case basis. 

36 Licensees authorized to possess byproduct material with half-lives greater than 120 days and in 

37 excess of the limits specified in 10 CFR 30.35 must also provide evidence of financial 

38 assurance for decommissioning. The requirements for financial assurance are specific to the 

39 types and quantities of byproduct material authorized on a license. Some medical use 

40 applicants and licensees may not need to take any action to comply with the financial assurance 

41 requirements, because their total inventory of licensed material does not exceed the limits in 

42 10 CFR 30.35 or because the half-life of the unsealed byproduct material used does not exceed 

43 120 days. Applicants requesting licensed material with a half-life in excess of 120 days should 

Part 35 Applicability

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8-10 

1 determine whether financial assurance is necessary. In addition, applicants requesting more 

2 than one radionuclide must use the sum-of-the-ratios method to determine if financial assurance 

3 is needed. 

4 Applications for authorization to possess and use unsealed byproduct material with a half-life 

5 exceeding 120 days must be accompanied by a decommissioning funding plan or certification of 

6 financial assurance when the trigger quantities given in 10 CFR 30.35(a) are exceeded. 

7 Acceptable methods of providing financial assurance may be found in NUREG–1757, Volume 3, 

8 “Consolidated Decommissioning Guidance: Financial Assurance, Recordkeeping, and 

9 Timeliness.” 

10 The NRC will authorize sealed source possession exceeding the limits given in 10 CFR 30.35(d)

11 without requiring decommissioning financial assurance, for the purpose of a normal sealed 

12 source exchange, on a case-by-case basis. For example, the licensee may temporarily exceed 

13 the limits in 10 CFR 30.35(d) requiring decommissioning financial assurance during source 

14 exchange for GSR. 

15 Determining Need for Financial Assurance for Decommissioning 

16 The half-lives of unsealed byproduct material used by medical licensees have traditionally been 

17 less than 120 days. Therefore, most medical use applicants need only consider Ra-226 and 

18 licensed material in sealed sources to evaluate the need for financial assurance. Use Table 8-1

19 to determine if financial assurance is required for the sealed sources listed. If requesting sealed 

20 sources other than those listed or any other unsealed byproduct material with a half-life greater 

21 than 120 days, refer to 10 CFR 30.35 and Appendix B to 10 CFR Part 30 for possession limits 

22 requiring financial assurance. The sum-of-the-fractions procedure is also depicted in Table 8-1

23 and must be used to determine the need for financial assurance for both sealed and unsealed 

24 byproduct material. 

Table 8-1. Worksheet for Determining Need for Financial Assurance for Sealed Sources 

Step Number Description Cobalt-60 Cesium-137 Strontium-90 

1 Activity possessed, in curies* 

2 Activity requiring financial 

assurance, in curies 

10,000 100,000 1,000 

3 Divide data in Step 1 by data in 

Step 2 = FRACTION 

 

4 Add the fractions determined in 

Step 3 

 

*This table uses only conventional units. The conversion to the International System of units is: 

1 curie = 37 gigabecquerels. 

25 As 10 CFR 30.35 describes, if the sum of the fractions is greater than or equal to 1, the 

26 applicant will need to submit a decommissioning funding plan or financial assurance, 

27 as applicable. 

28 Response from Applicant: No response is needed from most applicants. If financial 

29 assurance is required, applicants must submit evidence of financial assurance following the 

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

31 Assurance, Recordkeeping, and Timeliness,” February 2012. If applicants have questions 

32 about financial assurance requirements associated with discrete sources of Ra-226, they should 

33 consult with the appropriate NRC Regional Office to discuss the contents of their application. 
8-11 

1 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used 

2 Regulations: 10 CFR 30.33(a)(1), 10 CFR 35.100, 10 CFR 35.200, 10 CFR 35.300, 

3 10 CFR 35.400, 10 CFR 35.500, 10 CFR 35.600, 10 CFR 35.1000. 

4 Criteria: Byproduct material for medical use in 10 CFR Part 35 is 

5 divided into seven types of use: 10 CFR 35.100, 35.200, 35.300, 

6 35.400, 35.500, 35.600, and 35.1000. The applicant should refer to 

7 Table C–1 of Appendix C of this NUREG for an acceptable method 

8 for describing purpose of use. 

9 Discussion: 10 CFR 30.33(a)(1) limits the purpose of use 

10 authorized by the Atomic Energy Act of 1954, as Amended. Details 

11 for each purpose of use are listed below. 

12 10 CFR 35.100, 35.200, and 35.300 Use: The applicant should define the purpose of use by 

13 stating the applicable section of 10 CFR Part 35 (e.g., 10 CFR 35.100) and the description of 

14 the applicable modality (e.g., any uptake, dilution, and excretion study). 

15 For licensees conducting sentinel lymph node (SLN) biopsy, SLN tissue may be transferred to a 

16 nonlicensed facility for pathology analysis as long as the tissue does not contain more than 

17 100 μCi [3.7 megabecquerels (MBq)] of Tc-99m, which is based on the exemption criteria in 

18 10 CFR 30.18, “Exempt Quantities.” See RIS 2008-31, “Licensing Requirements for Sentinel 

19 Lymph Node Biopsy,” December 1, 2008, for additional information. 

20 If an applicant’s request is limited to one radionuclide under 10 CFR 35.300, the license will be 

21 limited to that radionuclide. In addition, the radionuclide and purpose may be limited, if the AU’s 

22 training or experience is limited. 

23 35.400 Use: The applicant should define the purpose of use by stating that the applicable 

24 section is 10 CFR 35.400, and the use is manual brachytherapy. 

25 In manual brachytherapy, several types of treatments are available. These may include, 

26 for example 

27  interstitial treatment of cancer 

28  eye plaque implants (considered interstitial, not topical, treatment) 

29  intracavitary treatment of cancer (for purposes of the NRC’s sealed source and device 

30 evaluation on radiation safety issues, intraluminal use is considered analogous to 

31 intracavitary use) 

32  topical (surface) applications [e.g., strontium-90 (Sr-90) eye applicators] 

33 35.500 Use: The applicant should define the purpose of use by stating that the applicable use 

34 is 10 CFR 35.500 and, if applicable, confirm that the sources requested in Item 5 and the 

35 associated devices are compatible. 

36 35.600 Use: The applicant should define the purpose of use by stating the applicable section of 

37 10 CFR 35.600 (e.g., teletherapy, remote afterloading, GSR) and include the manufacturer’s 

Part 35 Applicability

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8-12 

1 name(s) and model number(s) of the device(s) containing a sealed source(s) [e.g., for use in a 

2 (Manufacturer’s Name and Unit Type, Model) radiation therapy unit for the treatment of 

3 humans]. An applicant may consult with the proposed supplier or manufacturer to ensure that 

4 requested sources and devices are compatible and conform to the SSD registry designations 

5 registered with the NRC or an Agreement State. If applicable, the applicant should specify that 

6 authorization is being requested for an additional source to be stored in its shipping container, 

7 incident to source replacement. 

8 Shielding Material/Depleted Uranium Use: If applicable, the applicant should state that 

9 depleted uranium is used as shielding or collimation for a medical device. 

10 35.1000 Use: The applicant must apply for authorization to use byproduct material, or radiation 

11 therefrom, in medical applications under 10 CFR 35.1000 when the type of use is not covered 

12 under 10 CFR 35.100-35.600. Applicants should refer to the Medical Uses Licensee Toolkit and 

13 consult with the appropriate NRC Regional Office to discuss the contents of the application. 

14 Non-medical Uses: Applicants may also describe nonmedical uses [e.g., radiation survey 

15 meter calibrations with National Institute of Standards and Technology (NIST)-traceable 

16 brachytherapy sources] and reference the applicable radioactive material provided in response 

17 to Item 5. 

18 Response from Applicant: The applicant must submit information regarding the purpose for 

19 which the licensed material will be used. The applicant should consider including the 

20 information described above, as applicable to the type of use(s) proposed. 

21 When responding to this section, follow the guidance in Chapter 6, “Identifying and Protecting 

22 Sensitive Information,” to determine if the response includes security-related sensitive 

23 information and needs to be marked accordingly. 

24 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and 

25 Their Training and Experience 

26 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.24, 

27 10 CFR 35.50, 10 CFR 35.51, 10 CFR 35.55, 10 CFR 35.57, 

28 10 CFR 35.59, 10 CFR 35.190, 10 CFR 35.290, 10 CFR 35.390, 

29 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 

30 10 CFR 35.491, 10 CFR 35.590, 10 CFR 35.690. 

31 Criteria: The RSO, AUs, AMPs, and ANPs must have adequate 

32 training and experience. 

33 Discussion: The requirements in 10 CFR 35.24, “Authority and 

34 responsibilities of the radiation protection program,” describe the authority and responsibilities 

35 for the radiation protection program, including those of the licensee’s management and the RSO 

36 appointed by licensee management. Other personnel who have a role in the radiation 

37 protection program are AUs, AMPs, ANPs, and members of the Radiation Safety Committee 

38 (RSC), if the licensee is required to establish an RSC. The AU, AMP, ANP, and RSO are 

39 defined in 10 CFR 35.2, “Definitions.” The term AU will be used to also mean individuals who 

40 are authorized for nonmedical uses. In 10 CFR 30.33(a)(3), the NRC requires that an applicant 

41 be qualified by training and experience to use licensed materials for the purposes requested in 

42 such a manner as to protect health and minimize danger to life or property. Subparts B, D, E, F, 

Part 35 Applicability

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1000 ✓
8-13 

1 G, and H of 10 CFR Part 35 give specific criteria for acceptable training and experience for AUs 

2 for medical use, ANPs, the RSO, and AMPs; AUs for nonmedical uses must meet the criteria in 

3 10 CFR 30.33(a)(3). 

4 Applicants should ensure that they submit the specific training information required by NRC 

5 regulations in 10 CFR Part 35, Subparts B, D, E, F, G, and H. The NRC Form 313A series of 

6 forms provides a convenient format for submitting this information. A résumé or a curriculum 

7 vitae is not generally appropriate, because such documents usually contain PII (See Chapter 6, 

8 “Identifying and Protecting Sensitive Information”), and the document usually does not supply all 

9 the information needed to evaluate an individual’s training and experience for NRC purposes. 

10 In addition, 10 CFR 35.57 describes “grandfathering” of RSOs, AMPs, AUs and ANPs and 

11 10 CFR 35.59, “Recentness of training,” requires that the training and experience specified in 

12 10 CFR 35, Subparts B, D, E, F, G, and H, must have been obtained within 7 years preceding 

13 the date of application, or the individual must have related continuing education and experience. 

14 For nonmedical use AUs, the information provided should focus on educational training and 

15 radiation safety training and experience specific to the radionuclides and uses requested. 

16 Licensees may contract for medical use services, including those involving patient services. 

17 However, the licensee should not assume that, by hiring a contractor (e.g., consultant) to 

18 provide certain services, it has satisfied all regulatory requirements or that it has transferred 

19 responsibility for the licensed program to the contractor. Licensee management should ensure 

20 that adequate mechanisms for oversight are in place to determine that the radiation protection 

21 program, including the training of contractor staff, is effectively implemented by the 

22 appropriate individuals. 

23 Licensees are responsible for their radiation protection programs; it is essential that 

24 management oversight is in place to ensure that licensed activities are in accordance with the 

25 regulations and the licensees procedures. The licensee’s management must appoint an RSO, 

26 who agrees in writing to be responsible for implementing the radiation protection program, and 

27 must provide the RSO sufficient authority, organizational freedom, time, resources, and 

28 management prerogative to communicate with personnel and direct personnel regarding NRC 

29 regulations and license provisions, including: identifying radiation safety problems; initiating, 

30 recommending, or providing corrective actions; stopping unsafe operations; and verifying the 

31 implementation of corrective actions. Nevertheless, the licensee retains the ultimate 

32 responsibility for the conduct of licensed activities. 

33 Licensees that are authorized for two or more different types of uses of byproduct material 

34 under 10 CFR Part 35 Subparts E, F, and H, or two or more types of units under Subpart H are 

35 required under 10 CFR 35.24(f) to establish an RSC to oversee all uses of byproduct material 

36 permitted by the license. Membership in the committee must include an AU for each type of use 

37 permitted by the license, the RSO, a representative of the nursing service, and a representative 

38 of management who is neither an AU nor the RSO. The committee may include other members 

39 the licensee considers appropriate. 

40 Response from Applicant: Refer to Sections 8.7.1 – 8.7.4 for each type of individual 

41 responsible for the radiation protection program. 

Part 35 Applicability
8-14 

1 8.7.1 Radiation Safety Officer (RSO) 

2 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.13, 

3 10 CFR 35.14, 10 CFR 35.24, 10 CFR 35.50, 10 CFR 35.57, 

4 10 CFR 35.59. 

5 Criteria: The licensee must also establish, in writing, the authority, 

6 duties, and responsibilities of the RSO as required by 10 CFR 

7 35.24(e). The RSO must have adequate training and experience. 

8 The training and experience requirements for the RSO are described in 10 CFR 35.50, “Training 

9 for Radiation Safety Officer,” and allow for the following training pathways: 

10  certification as provided in 10 CFR 35.50(a) by a specialty board whose certification 

11 process has been recognized by the NRC or an Agreement State, plus a written 

12 attestation signed by a preceptor RSO as provided in 35.50(d) and training as specified 

13 in 35.50(e) 

14  completion of classroom and laboratory training (200 hours) and 1 year of full-time 

15 radiation safety experience as described in 10 CFR 35.50(b)(1) plus a written attestation 

16 signed by a preceptor RSO as provided in 10 CFR 35.50(d) and training as specified 

17 in 35.50(e)

18  certification as provided in 10 CFR 35.50(c)(1) as a medical physicist under 35.51(a), 

19 plus a written attestation signed by a preceptor RSO as provided in 10 CFR 35.50(d)

20 and training as specified in 35.50(e)

21  identification as provided in 10 CFR 35.50(c)(2) on the licensee’s license as an AU, 

22 AMP, or ANP with experience in the radiation safety aspects of similar types of 

23 byproduct material use for which the individual has RSO responsibilities, with a written 

24 attestation signed by a preceptor RSO as provided in 10 CFR 35.50(d) and training as 

25 specified in 35.50(e)

26 Discussion: The person responsible for the radiation protection program is the RSO. The 

27 RSO is key to overseeing and ensuring safe operation of the licensee’s radiation protection 

28 program. The RSO must have adequate training to understand the hazards associated with 

29 radioactive material and be familiar with all applicable regulatory requirements. The RSO 

30 should have independent authority to stop operations that he or she considers unsafe. In 

31 accordance with 10 CFR 35.24, “Authority and responsibilities of the radiation protection 

32 program,” the licensee must provide the RSO sufficient authority, organizational freedom, time, 

33 and resources to perform his or her duties. Additionally, the RSO must have a sufficient 

34 commitment from management to fulfill the duties and responsibilities specified in 10 CFR 35.24

35 to ensure that radioactive materials are used in a safe manner. 

36 Typical RSO duties are described in the list below and in Appendix I of this NUREG. The NRC 

37 requires the name of the RSO to be listed on the license to ensure that licensee management 

38 always has a responsible, qualified person identified and that the named individual knows of his 

39 or her designation as RSO. Appendix I of this NUREG also provides a model Delegation of 

40 Authority, which should be used to further emphasize the agreement on duties and 

41 responsibilities of the RSO by management and the designated RSO. NRC Form 313A (RSO), 

42 “Radiation Safety Officer” can be found on the Medical Uses Licensee Toolkit. Instructions for 

43 completing the form can be found in Appendix D of this NUREG. 

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-15 

1 Usually, the RSO is a full-time employee of the licensed facility. The NRC has authorized 

2 individuals who are not employed full-time by the licensee, such as a consultant, to fill the role of 

3 RSO or to provide support to the facility RSO. In order to fulfill the duties and responsibilities, 

4 the RSO should be onsite periodically to conduct meaningful, person-to-person interactions with 

5 licensee staff, commensurate with the scope of licensed activities, to satisfy the requirements of 

6 10 CFR 35.24. 

7 RSO Responsibilities: Some of the typical duties and responsibilities of RSOs include 

8 the following: 

9  stopping unsafe activities involving licensed materials 

10  ensuring radiation exposures are ALARA 

11  conducting material accountability and disposal 

12  interacting with the NRC 

13  providing timely and accurate reporting and maintenance of appropriate records 

14  conducting annual program audits 

15  ensuring proper use and routine maintenance 

16  ensuring personnel are trained 

17  conducting investigations of incidents involving byproduct material (e.g., medical events) 

18  for licensees possessing an aggregated Category 1 or Category 2 quantity of radioactive 

19 material, participating in the development and implementation of a security program for 

20 radioactive material in accordance with 10 CFR Part 37. A “Category 1 quantity of 

21 radioactive material” and a “Category 2 quantity of radioactive material” are defined 

22 terms in 10 CFR 37.5, and the radionuclides referenced in these 10 CFR 37.5 definitions 

23 are listed in Appendix A to 10 CFR Part 37 

24 Applicants are reminded of recentness of training requirements described in 10 CFR 35.59. 

25 Specifically, RSO applicants must have successfully completed the applicable training and 

26 experience described in 10 CFR Part 35 within 7 years preceding the date of the application. 

27 Alternatively, RSO applicants must submit documentation for related continuing education and 

28 experience since completing the required training and experience. This time provision applies 

29 to board certification as well as to other pathways to meeting requirements for training 

30 and experience. 
8-16 

1 Response from Applicant: Provide the following: 

2  name of the proposed RSO 

3 AND 

4 For an individual previously identified as an RSO on an NRC or Agreement State license 

5 or permit

6  previous license number (if issued by the NRC) or a copy of the license (if issued by an 

7 Agreement State) or a copy of a permit issued by a NRC master materials licensee on 

8 which the individual was named as the RSO

9 For an individual qualifying under 10 CFR 35.57(a)(3)

10 (Note: This is only for a new medical use license requesting use of only accelerator-produced 

11 radioactive material, discrete sources of Ra-226, or both, for the same uses authorized under 

12 NRC’s waiver of August 31, 2005.) 

13  documentation that this individual functioned as an RSO for only accelerator-produced 

14 radioactive materials, discrete sources of Ra-226, or both, before or during the effective 

15 period of NRC’s waiver of August 7, 2005 

16 AND 

17  documentation that the individual performed as the RSO for the same medical 

18 uses requested

19 For an individual qualifying under 10 CFR 35.50(a)

20  copy of certification by a specialty board whose certification process has been 

recognized1 21 by the NRC or an Agreement State under 10 CFR 35.50(a)

22 AND 

23  description of the training and experience specified in 10 CFR 35.50(e) demonstrating 

24 that the proposed RSO is qualified by training in the radiation safety, regulatory issues, 

25 and emergency procedures as applicable to the types of use for which the applicant 

26 seeks approval of an individual to serve as RSO 

27 AND 

28  written attestation, signed by a preceptor RSO, that the individual has successfully 

29 completed the training and experience specified for certification, as well as the required 

30 training and experience in radiation safety, regulatory issues, and emergency 

31 procedures for the types of use for which the licensee seeks approval and has achieved 

32 a level of radiation safety knowledge sufficient to function independently as an RSO 

 

1

Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit. 
8-17 

1 AND 

2  if applicable, description of recent related continuing education and experience as 

3 required by 10 CFR 35.59

4 For an individual qualifying under 10 CFR 35.50(b)

5  description of the training and experience specified in 10 CFR 35.50(b) demonstrating 

6 that the proposed RSO is qualified by training and experience as applicable to the types 

7 of use for which the applicant seeks approval of an individual to serve as RSO 

8 AND 

9  description of the training and experience specified in 10 CFR 35.50(e) demonstrating 

10 that the proposed RSO is qualified by training in radiation safety, regulatory issues, and 

11 emergency procedures as applicable to the types of use for which the applicant seeks 

12 approval of an individual to serve as RSO 

13 AND 

14  written attestation, signed by a preceptor RSO, that the individual has successfully 

15 completed the training and experience in 10 CFR 35.50(b), as well as the required 

16 training and experience in radiation safety, regulatory issues, and emergency 

17 procedures for the types of use for which the licensee seeks approval and has achieved 

18 a level of radiation safety knowledge sufficient to function independently as an RSO 

19 AND 

20  if applicable, description of recent related continuing education and experience as 

21 required by 10 CFR 35.59

22 For an individual qualifying under 10 CFR 35.50(c)(1)

23  copy of the certification(s) as a medical physicist by a board whose certification process 

24 has been recognized by the NRC or an Agreement State under 10 CFR 35.51(a) and 

25 description of the experience specified in 35.50(c)(1) demonstrating that the proposed 

26 RSO is qualified by experience applicable to the types of use for which the applicant 

27 seeks approval of an individual to serve as RSO 

28 AND 

29  description of the training and experience specified in 10 CFR 35.50(e) demonstrating 

30 that the proposed RSO is qualified by training in radiation safety, regulatory issues, and 

31 emergency procedures as applicable to the types of use for which the applicant seeks 

32 approval of an individual to serve as RSO 

33 AND 

34  written attestation, signed by a preceptor RSO, that the individual has satisfactorily 

35 completed the requirements in 35.50(c)(1), as well as the required training and 

36 experience in radiation safety, regulatory issues, and emergency procedures for the 
8-18 

1 types of use for which the licensee seeks approval and has achieved a level of radiation 

2 safety knowledge sufficient to function independently as an RSO 

3 AND 

4  if applicable, description of recent related continuing education and experience as 

5 required by 10 CFR 35.59. 

6 For an individual qualifying under 10 CFR 35.50(c)(2)

7  copy of the licensee’s license indicating that the individual is an AU, AMP, or ANP 

8 identified on the licensee’s license and has experience with the radiation safety aspects 

9 of similar types of use of byproduct material for which the applicant seeks approval of an 

10 individual to serve as RSO 

11 AND 

12  description of the training and experience specified in 10 CFR 35.50(e) demonstrating 

13 that the proposed RSO is qualified by training in radiation safety, regulatory issues, and 

14 emergency procedures applicable to the types of use for which the applicant seeks 

15 approval of an individual to serve as RSO 

16 AND 

17  written attestation, signed by a preceptor RSO, that the individual satisfactorily 

18 completed the requirements in 35.50(c)(2), as well as the required training and 

19 experience in radiation safety, regulatory issues, and emergency procedures for the 

20 types of use for which the licensee seeks approval and has achieved a level of radiation 

21 safety knowledge sufficient to function independently as an RSO 

22 AND 

23  if applicable, description of recent related continuing education and experience as 

24 required by 10 CFR 35.59

25 AND 

26  If the RSO is an outside consultant or contractor, address the following in the application 

27 or amendment: 

28 — Identify other commitments of the consultant-RSO for other NRC or Agreement 

29 State licensed facilities, along with a description of how the consultant-RSO will 

30 allocate time to permit the performance of the duties of the RSO as described in 

31 the regulations. State the consultant-RSO’s minimum amount of onsite time 

32 (hours per week). 

33 — Appoint an in-house representative who will serve as the point of contact during 

34 the RSO’s absence. This person may be allowed to assist the consultant RSO 

35 with limited authority. 
8-19 

1 — Describe the overall availability of the consultant-RSO to respond to questions or 

2 operational issues that arise during the conduct of the radiation safety program 

3 and related regulatory requirements. 

4 — Specify the maximum amount of time it will take the RSO to arrive at the facility in 

5 the event of an emergency that requires his or her presence. 

6 Notes:

7  NRC Form 313A (RSO), “Radiation Safety Officer Training and Experience and 

8 Preceptor Attestation [10 CFR 35.50],” may be used to document training and 

9 experience for those individuals qualifying under 10 CFR 35.50. 

10  The licensee must notify the NRC within 30 days if, under 10 CFR 35.14, “Notifications,” 

11 an RSO permanently discontinues his or her duties under the license or has a name 

12 change; licensees must also request an amendment to change an RSO under 

13 10 CFR 35.13. 

14  An AU for medical uses, AMP, or ANP may be designated as the RSO on the license if 

15 the individual has experience with the radiation safety aspects of similar types of 

16 byproduct material use for which he or she has RSO responsibilities [see 

17 10 CFR 35.50(c)(2)] and, as required by 10 CFR 35.24(g), has sufficient time, authority, 

18 organizational freedom, resources, and management prerogative to perform the duties. 

19  Descriptions of training and experience will be reviewed using the criteria listed above. 

20 The NRC will review the documentation to determine if the applicable criteria in 

21 10 CFR Part 35, Subpart B, are met. If the training and experience do not appear to 

22 meet the criteria in Subpart B, the NRC may request additional information from the 

23 applicant or may request the assistance of the Advisory Committee on the Medical Uses 

24 of Isotopes (ACMUI) in evaluating such training and experience. 

25  The training and experience for the RSO of a medical use broad scope license will be 

26 reviewed using the above criteria as well as criteria in 10 CFR Part 33 “Specific 

27 Domestic Licenses of Broad Scope for Byproduct Material.” 

28 8.7.2 Authorized Users (AUs) 

29 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14, 

30 10 CFR 35.27, 10 CFR 35.57, 10 CFR 35.59, 10 CFR 35.190, 

31 10 CFR 35.290, 10 CFR 35.390, 10 CFR 35.392, 10 CFR 35.394, 

32 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.590, 

33 10 CFR 35.690

34 Criteria: Training and experience requirements for AUs for medical 

35 uses are described in 10 CFR 35.190, 10 CFR 35.290, 

36 10 CFR 35.390, 10 CFR 35.392, 10 CFR 35.394, 10 CFR 35.396, 

37 10 CFR 35.490, 10 CFR 35.491, 10 CFR 35.590, or 10 CFR 35.690

38 Discussion: 10 CFR 35.2 defines AU for medical use. Although the NRC does not define “AU” 

39 for nonmedical uses, for purposes of this discussion the term AU will also be used to mean 

40 individuals authorized for the nonmedical uses described below. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-20 

1 AU for Medical Uses: The responsibilities of AUs involved in medical use include the following: 

2  radiation safety commensurate with use of byproduct material 

3  administration of a radiation dose or dosage and how it is prescribed 

4  direction of individuals under the AU’s supervision in the preparation of byproduct 

5 material for medical use and in the medical use of byproduct material 

6  preparation of written directive (WD), if required 

7 Applicants must meet recentness of training requirements described in 10 CFR 35.59. The AU 

8 applicants must have successfully completed the applicable training and experience criteria 

9 described in 10 CFR Part 35 within 7 years preceding the date of the application. Alternatively, 

10 applicants must submit documentation for related continuing education and experience since 

11 completing the required training and experience. This time provision applies to board 

12 certification as well as to other training pathways. 

13 Regulations in 10 CFR 35.57, “Training for experienced Radiation Safety Officer, teletherapy or 

14 medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and 

15 authorized nuclear pharmacist,” provide that experienced AUs who are named on a license or 

16 permit are not required to comply with the training requirements in Subparts D through H to 

17 continue performing those medical uses for which they were authorized before the effective date 

18 of changes to the regulations in 10 CFR 35.57 (check the regulations to determine this date). 

19 For example, a physician who was authorized to use sodium iodine-131 (I-131) for imaging and 

20 localization, involving greater than 30 μCi (a quantity for which a WD is required under 

21 10 CFR 35.40), would continue to be authorized for this use. 

22 Technologists, therapists, or other personnel may use byproduct material for medical use under 

23 an AU’s supervision in accordance with 10 CFR 35.27, “Supervision,” and in compliance with 

24 applicable FDA and other Federal and State requirements (10 CFR 35.7). Examples include 

25 FDA requirements for the conduct of certain types of clinical research after the submission of 

26 applications for Investigational New Drugs and under the auspices of a Radioactive Drug 

27 Research Committee (21 CFR 361.1). 

28 There is no NRC requirement that an AU must render an interpretation of a diagnostic image or 

29 results of a therapeutic procedure. The NRC recognizes that the AU may or may not be the 

30 physician who interprets such studies. Additionally, NRC regulations do not restrict who can 

31 read and interpret diagnostic scans or the results of therapeutic procedures involving the 

32 administration of byproduct material to individuals. 

33 NRC Forms 313A (AUD, AUT, and AUS) can be found on the Medical Uses Licensees Toolkit. 

34 Instructions for completing the form can be found in Appendix D of this NUREG. Information in 

35 10 CFR 35.1000, “Other medical uses of byproduct material or radiation from byproduct 

36 material,” regarding training and experience for emerging technologies (e.g., microspheres) can 

37 also be found at the Medical Use Licensee Toolkit. 

38 AU for Non-medical Uses: For in vitro studies, animal research, calibration of survey 

39 instruments, and other uses that do not involve the intentional exposure of humans, the list of 

40 proposed AUs should include the individuals who will actually be responsible for the safe use of 

41 the byproduct material for the requested use. 
8-21 

1 An applicant should note which user will be involved with a particular use by referring to Items 5 

2 and 6 of the application and providing information about the user’s training and experience. 

3 Authorized non-medical use or uses that do not involve the intentional exposure of humans 

4 (e.g., in vitro and animal research, calibration, dosimetry research) will be reviewed on a 

5 case-by-case basis. 

6 Response from Applicant: 

7 AU for Medical Uses: Provide the following: 

8  name of the proposed AU and uses requested 

9 AND 

10  state or territory where licensed 

11 AND 

12 For an individual previously identified as an AU on an NRC or Agreement State license 

13 or permit

14  Previous license number (if issued by the NRC) or a copy of the license (if issued by an 

15 Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

16 permit issued by an NRC or Agreement State broad scope licensee, or a permit issued 

17 by an NRC Master Materials License (MML) broad scope permittee on which the 

18 physician, dentist, or podiatrist was specifically named as an AU for the uses requested; 

19 AND 

20  For an AU requesting a medical use not currently authorized on a license or permit, a 

21 description of the additional training and experience is needed to demonstrate the AU is 

22 also qualified for the new medical uses requested [e.g., training and experience needed 

23 to meet the requirements in 10 CFR 35.290(b), 35.396, 35.390(b)(1)(ii)(G) or 35.690(c)]. 

24 A preceptor attestation may also be required. (For example, a preceptor attestation is 

25 needed to meet the requirements of 10 CFR 35.396, “Training for the parenteral 

26 administration of unsealed byproduct material requiring a written directive,” and 35.690, 

27 “Training for use of remote afterloader units, teletherapy units, and gamma stereotactic 

28 radiosurgery units.”)

29 For an individual qualifying under 10 CFR 35.57(b)(3)

30  Documentation that the physician, dentist, or podiatrist used only accelerator-produced 

31 radioactive materials, discrete sources of Ra-226, or both, for medical uses before or 

32 during the effective period of NRC’s waiver of August 31, 2005. 

33 AND 

34  Documentation that the physician, dentist, or podiatrist used these materials for the 

35 same medical uses requested. 

36 AND 
8-22 

1  For an AU requesting a medical use for which he or she is not currently authorized on a 

2 license or permit, a description of the additional training and experience to demonstrate 

3 the AU is also qualified for the new medical uses requested. A preceptor attestation 

4 may also be required. [For example, training, experience, and attestations are needed 

5 to meet the requirements in 10 CFR 35.290(b), 35.396, 35.390(b)(1)(ii)(G), or 35.690(c).] 

6 For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H, who is 

7 board-certified

8  A copy of the certification(s) by a specialty board(s) whose certification process has 

been recognized2 9 by the NRC under 10 CFR Part 35, Subpart D, E, F, G, or H, as 

10 applicable to the use requested. 

11 AND 

12  For a physician with a board certification recognized under 10 CFR 35.390, a description 

13 of the supervised work experience administering dosages of radioactive drugs required 

14 in 10 CFR 35.390(b)(1)(ii)(G) demonstrating that the proposed AU is qualified for the 

15 types of administrations for which authorization is sought. 

16 AND 

17  For a physician with a board certification recognized under 10 CFR 35.290 for medical 

18 uses described in 10 CFR 35.200, a description of the supervised work experience 

19 eluting generator systems required in 10 CFR 35.290(c)(1)(ii)(G) demonstrating that the 

20 proposed AU is also qualified for imaging and localization medical uses. 

21 AND 

22  For a physician with a board certification recognized under 10 CFR 35.490 or 

23 10 CFR 35.690 for medical uses described in 10 CFR 35.396, a description of the 

24 training and supervised work experience and a copy of the attestation required in 

25 10 CFR 35.396(d) to demonstrate qualifications for administering parenteral 

26 administrations of unsealed byproduct material requiring a WD. 

27 AND 

28  For an individual seeking authorization under 10 CFR Part 35, Subpart H, a description 

29 of the training specified in 10 CFR 35.690(c) demonstrating that the proposed AU is 

30 qualified for the type(s) of use for which authorization is sought. 

31 AND 

32  A written attestation, signed by a preceptor physician AU, that the training and 

33 experience specified for certification have been satisfactorily completed and that a level 

34 of competency sufficient to function independently as an AU for the medical uses 

35 authorized has been achieved. For individuals seeking authorization under 

 

2

Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit. 
8-23 

1 10 CFR 35.390, 10 CFR 35.396, and 10 CFR 35.690, the attestation must also include 

2 successful completion of the clinical case work in 10 CFR 35.390(b)(1)(ii)(G), or training 

3 and experience required by 10 CFR 35.396(d), or training for 10 CFR 35.600 types of 

4 use, as appropriate. 

5 AND 

6  If applicable, a description of recent related continuing education and experience as 

7 required by 10 CFR 35.59. 

8 For an individual qualifying under 10 CFR Part 35, Subparts D, E, F, G, and/or H, who is not 

9 board-certified

10  a description of the training and experience identified in 10 CFR Part 35, Subparts D, E, 

11 F, G, and H, demonstrating that the proposed AU is qualified by training and experience 

12 for the use(s) requested 

13 AND 

14  for an individual seeking authorization under 10 CFR Part 35, Subpart H, a description of 

15 the training specified in 10 CFR 35.690(c), demonstrating that the proposed AU is 

16 qualified for the type(s) of use for which authorization is sought 

17 AND 

18  a written attestation, signed by a preceptor physician AU, that the above training and 

19 experience have been satisfactorily completed and that a level of competency sufficient 

20 to function independently as an AU for the medical uses authorized has been achieved 

21 AND 

22  if applicable, a description of recent related continuing education and experience as 

23 required by 10 CFR 35.59

24 For an individual qualifying under Subpart K 

25  Training and experience as described for the emerging technology on the Medical Uses 

26 Licensee Toolkit. 

27 Notes:

28  NRC Form 313A (AUD), “Authorized User Training and Experience and Preceptor 

29 Attestation (for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.190, 

30 35.290, and 35.590];” or NRC Form 313A (AUT), “Authorized User Training and 

31 Experience and Preceptor Attestation (for uses defined under 35.300) [10 CFR 35.390, 

32 35.392, 35.394, and 35.396];” or NRC Form 313A (AUS), “Authorized User Training and 

33 Experience and Preceptor Attestation (for uses defined under 35.400 and 35.600) 

34 [10 CFR 35.490, 35.491, and 35.690]” may be used as appropriate to document training 

35 and experience for those individuals qualifying under 10 CFR Part 35, Subparts D, E, F, 

36 G, and/or H. 
8-24 

1  Licensees must notify the NRC within 30 days if an AU permanently discontinues his or 

2 her duties under the license or has a name change under 10 CFR 35.14. 

3  Descriptions of training and experience will be reviewed using the criteria listed above. 

4 The NRC will review the documentation to determine if the applicable criteria in 

5 10 CFR Part 35 are met. If the training and experience do not appear to meet the 

6 10 CFR Part 35 criteria, the NRC may request additional information from the applicant 

7 or may request the assistance of the ACMUI in evaluating such training and experience. 

8 Note to reviewers: Licenses will reflect any limitations on use for listed AUs (e.g., whether 

9 administrations in excess of 33 mCi of I-131 are allowed and specific uses under 

10 10 CFR 35.600). 

11 AU for Nonmedical Uses: Provide the following: 

12  name of the proposed nonmedical use AU 

13  description of types, quantities, and proposed nonmedical uses for which the individual 

14 is responsible 

15  description of individual’s educational and radiation safety training and experience with 

16 the types of materials and uses requested; this may include 

17 — a copy of the NRC or Agreement State license listing the individual as an AU for 

18 the same types, quantities, and uses requested 

19 — a permit issued by an MML licensee or broad scope licensee or broad scope 

20 permittee identifying the individual as an AU for the types, quantities, and uses 

21 requested 

22  detailed radiation training and experience applicable to the use requested 

23 Note: Authorized nonmedical use or uses that do not involve the intentional exposure of 

24 humans (e.g., in vitro and animal research, calibration, dosimetry research) will be reviewed on 

25 a case-by-case basis. 

26 8.7.3 Authorized Nuclear Pharmacist (ANP) 

27 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 

28 10 CFR 35.11, 10 CFR 35.14, 10 CFR 35.27, 10 CFR 35.55, 

29 10 CFR 35.57, 10 CFR 35.59. 

30 Criteria: Training and experience requirements for ANPs are 

31 described in 10 CFR 35.55. 

32 Discussion: At many licensed medical facilities, an ANP is directly 

33 involved with the preparation of radiopharmaceuticals under the provisions of 

34 10 CFR 35.100(b), 35.200(b), or 35.300(b). 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 

500 

600 

1000 ✓
8-25 

1 Technologists, or other personnel, may prepare byproduct material for medical use under an 

2 ANP’s supervision in accordance with 10 CFR 35.27, “Supervision,” and in compliance with 

3 applicable FDA and other Federal and State requirements (10 CFR 35.7). (Preparation of 

4 byproduct material for medical use may also be performed under the supervision of a physician 

5 who is an AU.) 

6 Applicants are reminded that the recentness of training requirements described in 10 CFR 35.59

7 also apply to training and experience requirements in 10 CFR Part 35, Subpart B. Specifically, 

8 nuclear pharmacist applicants must have successfully completed the applicable training and 

9 experience criteria described in 10 CFR Part 35 within 7 years preceding the date of the 

10 application. Alternatively, nuclear pharmacist applicants must submit documentation for related 

11 continuing education and experience since initially completing the required training and 

12 experience. This time provision applies to board certification as well as to other training 

13 pathways for meeting requirements for training and experience. 

14 Response from Applicant: Provide the following: 

15  name of the proposed ANP 

16 AND 

17  state or territory where licensed 

18 AND 

19 For an individual previously identified as an ANP on an NRC or Agreement State license or 

20 permit or by a commercial nuclear pharmacy that has been authorized to identify ANPs

21  previous license number (if issued by the NRC) or a copy of the license (if issued by an 

22 Agreement State) or a copy of a permit issued by an NRC MML, a permit issued by an 

23 NRC or Agreement State broad scope licensee, or a permit issued by an NRC MML 

24 broad scope permittee on which the individual was named an ANP or a copy of an 

25 authorization as an ANP from a commercial nuclear pharmacy that has been authorized 

26 to identify ANPs 

27 OR 

28 For an individual qualifying under 10 CFR 35.57(a)(3)

29  documentation that the nuclear pharmacist used only accelerator-produced radioactive 

30 material, discrete sources of Ra-226, or both, in the practice of pharmacy before or 

31 during the effective period of NRC’s waiver of August 31, 2005 

32 AND 

33  documentation that the nuclear pharmacist used these materials for the same uses as 

34 requested 

35 OR 

36 
8-26 

1 For an individual qualifying under 10 CFR 35.55(a)

2  copy of the certification of the specialty board whose certification process has been 

recognized3 3 under 10 CFR 35.55(a); 

4 AND 

5  written attestation, signed by a preceptor ANP, that training and experience required for 

6 certification have been satisfactorily completed and that a level of competency sufficient 

7 to function independently as an ANP has been achieved. 

8 AND 

9  if applicable, description of recent related continuing education and experience as 

10 required by 10 CFR 35.59. 

11 OR 

12 For an individual qualifying under 10 CFR 35.55(b)

13  description of the training and experience specified in 10 CFR 35.55(b) demonstrating 

14 that the proposed ANP is qualified by training and experience 

15 AND 

16  written attestation, signed by a preceptor ANP, that the above training and experience 

17 have been satisfactorily completed and that a level of competency sufficient to function 

18 independently as an ANP has been achieved 

19 AND 

20  if applicable, description of recent related continuing education and experience as 

21 required by 10 CFR 35.59

22 Notes:

23  NRC Form 313A (ANP), “Authorized Nuclear Pharmacist Training and Experience and 

24 Preceptor Attestation [10 CFR 35.55]” may be used to document training and experience 

25 for those individuals qualifying under 10 CFR 35.55. 

26  Under 10 CFR 35.14, licensees must notify the NRC within 30 days if an ANP 

27 permanently discontinues his or her duties under the license or has a name change. 

28  Descriptions of training and experience will be reviewed using the criteria listed above. 

29 The NRC will review the documentation to determine if the applicable criteria in 

30 10 CFR Part 35, Subpart B are met. If the training and experience do not appear to 

31 meet the criteria in Subpart B, the NRC may request additional information from the 

 

3

Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit. 
8-27 

1 applicant or may request the assistance of the ACMUI in evaluating such training and 

2 experience. 

3 8.7.4 Authorized Medical Physicist (AMP) 

4 Regulations: 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.14, 

5 10 CFR 35.51, 10 CFR 35.57, 10 CFR 35.59

6 Criteria: Training and experience requirements for AMPs are 

7 described in 10 CFR 35.51. 

8 Discussion: While the AMP may not administer the dose, at 

9 licensed medical facilities conducting radiation therapy treatments, 

10 an AMP is directly involved with the calculation and other tasks 

11 associated with the administration of the radiation dose. The 

12 American Association of Physicists in Medicine (AAPM) suggests 

13 that a medical physicist limit his or her involvement in radiation therapy to areas for which he or 

14 she has established competency. 

15 Applicants are reminded of recentness of training requirements described in 10 CFR 35.59. 

16 Specifically, medical physicist applicants must have successfully completed the applicable 

17 training and experience criteria described in 10 CFR Part 35 within 7 years preceding the date 

18 of the application. Alternatively, medical physicist applicants must submit documentation for 

19 related continuing education and experience since completing the required training and 

20 experience. This time provision applies to board certification as well as to other training 

21 pathways for meeting requirements for training and experience. 

22 Response from Applicant: Provide the following: 

23  name of the proposed AMP 

24 AND 

25 For an individual previously identified as an AMP on an NRC or Agreement State license 

26 or permit

27  previous license number (if issued by the NRC) or a copy of the license (if issued by an 

28 Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

29 permit issued by an NRC or Agreement State broad scope licensee, or a permit issued 

30 by an NRC Master Materials License broad scope permittee on which the individual was 

31 specifically named an AMP for the uses requested 

32 OR 

33 For an individual qualifying under 10 CFR 35.57(a)(3)

34  documentation that the medical physicist used only accelerator-produced radioactive 

35 material, discrete sources of Ra-226, or both, for medical uses before or during the 

36 effective period of NRC’s waiver of August 31, 2005 

37 AND 

Part 35 Applicability

100 

200 

300 

400 ✓

500 

600 ✓

1000 ✓
8-28 

1  documentation that the medical physicist used these materials for the same medical 

2 uses as requested 

3 OR 

4 For an individual qualifying under 10 CFR 35.51(a)

5  copy of the certification(s) of the specialty board(s) whose certification process has been 

recognized4 6 under 10 CFR 35.51(a)

7 AND 

8  description of the training and experience specified in 10 CFR 35.51(c) demonstrating 

9 that the proposed AMP is qualified by training in the types of use for which he or she is 

10 requesting AMP status, including hands-on device operation, safety procedures, clinical 

11 use, and operation of a treatment planning system 

12 AND 

13  written attestation, signed by a preceptor AMP, that the required training and experience 

14 required for certification, as well as the required training in 10 CFR 35.51(c) for the types 

15 of uses specified, have been satisfactorily completed, and that a level of competency 

16 sufficient to function independently as an AMP has been achieved 

17 AND 

18  if applicable, a description of recent related continuing education and experience as 

19 required by 10 CFR 35.59

20 OR 

21 For an individual qualifying under 10 CFR 35.51 (b)

22  description of the training and experience demonstrating that the proposed AMP 

23 is qualified by training and experience identified in 10 CFR 35.51(b)(1) for the 

24 uses requested 

25 AND 

26  description of the training and experience specified in 10 CFR 35.51(c) demonstrating 

27 that the proposed AMP is qualified by training in the types of use for which the licensee 

28 seeks approval of an individual as AMP, including hands-on device operation, safety 

29 procedures, clinical use, and operation of a treatment planning system 

30 AND 

31  written attestation, signed by a preceptor AMP, that the training and experience required 

32 in 10 CFR 35.51(b)(1), as well as the training in 10 CFR 35.51(c) for the types of use 

 

4

Specialty board certifications recognized by the NRC are posted on the Medical Uses Licensee Toolkit. 
8-29 

1 specified, have been satisfactorily completed, and that a level of competency sufficient 

2 to function independently as an AMP has been achieved 

3 AND 

4  if applicable, a description of recent related continuing education and experience as 

5 required by 10 CFR 35.59

6 OR 

7 For an individual qualifying under Subpart K 

8  training and experience as described for the emerging technology on the Medical Uses 

9 Licensee Toolkit

10 Notes:

11  NRC Form 313A (AMP), “Authorized Medical Physicist Training and Experience and 

12 Preceptor Attestation [10 CFR 35.51],” may be used to document training and 

13 experience for those individuals qualifying under 10 CFR 35.51. 

14  Under 10 CFR 35.14, licensees must notify NRC within 30 days if an AMP permanently 

15 discontinues his or her duties under the license or has a name change. 

16  Descriptions of training and experience will be reviewed using the criteria listed above. 

17 The NRC will review the documentation to determine if the applicable criteria in 

18 10 CFR Part 35, Subpart B, are met. If the training and experience do not appear to 

19 meet the criteria in Subpart B, the NRC may request additional information from the 

20 applicant or may request the assistance of the ACMUI in evaluating such training and 

21 experience. 

22 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted 

23 Areas 

24 Regulations: 10 CFR 19.12, 10 CFR 35.27, 10 CFR 35.310, 

25 10 CFR 35.410, 10 CFR 35.610, 10 CFR 37.43

26 Criteria: Individuals working with or in the vicinity of licensed 

27 material must have adequate safety instructions as required by 

28 10 CFR Parts 19 and 35. For individuals who, in the course of 

29 employment, are likely to receive in a year an occupational dose of 

30 radiation over 1 millisievert (mSv) 

31 [100 millirem (mrem)], the licensee must provide safety instructions 

32 as required by 10 CFR 19.12, “Instruction to workers.” Additional requirements for training in 

33 radiation safety for individuals involved with therapeutic treatment of patients are described in 

34 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610. Under 10 CFR 35.27, the licensee’s AUs 

35 and ANPs are required to provide safety instruction to all personnel using byproduct material 

36 under their supervision. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-30 

1 Any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive 

2 material (as defined in 10 CFR 37.5) must implement a training program for those individuals 

3 implementing the security program. 

4 Discussion: The AUs, ANPs, AMPs, RSOs, and their supervised employees are most likely to 

5 receive doses in excess of 1 mSv [100 mrem] in a year. Licensees also must evaluate potential 

6 radiation doses received by any individual working in or frequenting restricted areas. All 

7 individuals working with or around licensed materials should receive safety instructions 

8 commensurate with their assigned duties, and if it is likely that they could receive doses over 

9 1 mSv [100 mrem] in a year, they must receive instructions as specified by 10 CFR 19.12. For 

10 example, a licensee might determine that housekeeping staff, while not likely to receive doses 

11 over 1 mSv [100 mrem], should be informed of the nature of the licensed material and the 

12 meaning of the radiation symbol and instructed not to touch the licensed material and to remain 

13 out of the room if the door to the licensed material storage location is open. Providing minimal 

14 instruction to ancillary staff (e.g., housekeeping, security) may assist in controlling abnormal 

15 events, such as loss of radioactive material. In addition, licensees should ensure that contractor 

16 staff receives safety instructions. 

17 In addition to safety instructions required by 10 CFR 19.12, and in accordance with 

18 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610, the licensee must provide radiation safety 

19 instructions to personnel (e.g., nurses) caring for patients undergoing radiopharmaceutical 

20 therapy and/or implant therapy who cannot be released in accordance with 10 CFR 35.75. This 

21 safety instruction should be commensurate with the duties of the personnel and include safe 

22 handling, patient control, visitor control, contamination control, waste control, and notification of 

23 the RSO and the AU, if the patient has a medical emergency or dies. 

24 In accordance with 10 CFR 35.27(a), individuals working with licensed material under the 

25 supervision of an AU must receive instructions on the licensee’s written radiation protection 

26 procedures, WD procedures, NRC regulations, and NRC license conditions with respect to the 

27 use of byproduct material. 

28 In accordance with 10 CFR 35.27(b), a licensee that permits the preparation of byproduct 

29 material for medical use by an individual under the supervision of an ANP or an AU, as allowed 

30 by 10 CFR 35.11(b)(2), shall instruct supervised individuals in the preparation of byproduct 

31 material for medical use and require the individuals to follow their instructions, the licensee’s 

32 written radiation protection procedures, the license conditions, and NRC regulations. Under 

33 10 CFR 35.27(c), a licensee that permits supervised activities, under paragraphs 

34 10 CFR 35.27(a) and (b), is responsible for the acts and omissions of the supervised 

35 individuals. 

36 Appendix J of this NUREG provides a model training program that provides one way to satisfy 

37 the requirements referenced above. In addition, the Medical Uses Licensee Toolkit provides 

38 guidance for training suggested for emerging technologies [e.g., yttrium-90 (Y-90) microsphere 

39 brachytherapy], regulated under 10 CFR 35.1000. 
8-31 

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. 

1 Response from Applicant: No response is necessary. 

2 8.9 Item 9: Facilities and Equipment 

3 Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.12(b)(1), 

4 10 CFR 35.18(a), 10 CFR Part 37, 10 CFR 37.5, 10 CFR 37.49, 10 

5 CFR 37.53. 

6 Criteria: Facilities and equipment must be adequate to protect 

7 health and minimize danger to life or property. 

8 If licensee possesses aggregated Category 1 and Category 2 

9 quantities of radioactive material, as defined by 10 CFR 37.5, 

10 facilities and equipment must be adequate to protect health and 

11 minimize danger to life or property and provide enhanced physical protection of the aggregated 

12 Category 1 and Category 2 quantities of radioactive material. 

13 Discussion: Requirements to provide information about the design and construction of facilities 

14 and safety equipment are contained in 10 CFR 30.33(a)(2), 35.12(b)(1), and 35.18(a). 

15 Applications will be approved if, among other things, “the applicant’s proposed equipment and 

16 facilities are adequate to protect health and minimize danger to life or property.” Facility and 

17 equipment requirements depend on the scope of the applicant’s operations (e.g., planned use of 

18 the material, types of radioactive emissions, quantity and form of radioactive materials 

19 possessed). Applicants should focus particularly on operations using large quantities of 

20 radioactive materials; preparation steps involving liquids, gases, and volatile radioactive 

21 materials; and the use of alpha-emitters, high-energy photon-emitters, and high-energy 

22 beta-emitters. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-32 

 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.

Response from Applicant: Refer to Sections 8.9.2 through 8.9.5 for guidance. 

1 8.9.1 Facility Diagram 

2 Regulations: 10 CFR 20.1003, 10 CFR 20.1101, 10 CFR 20.1201, 

3 10 CFR 20.1301, 10 CFR 20.1601, 10 CFR 20.1602, 

4 10 CFR 30.33(a)(2), 10 CFR 35.12, 10 CFR 35.13, 10 CFR 35.14, 

5 10 CFR 35.18(a)(3), 10 CFR 35.75, 10 CFR 35.315(a), 10 CFR 

6 35.415, 10 CFR 35.615

7 Criteria: In order to issue a license, the NRC must find that facilities 

8 and equipment are adequate to protect health and minimize danger 

9 to life or property as required under 10 CFR 30.33(a)(2) and/or 

10 35.18(a)(3). In accordance with 10 CFR 20.1101, the licensee must 

11 design facilities to achieve occupational doses and doses to members of the public ALARA. 

12 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 

600 ✓

1000 ✓
8-33 

1 Discussion: Applicants must describe the proposed facilities and equipment as required by 

2 10 CFR 30.33(a)(2) and 10 CFR 35.12. The facility diagram should include the room or rooms 

3 where byproduct material is prepared, used, administered, and stored, at a level of detail that is 

4 sufficient to demonstrate that the facilities and equipment are adequate to protect health and 

5 minimize danger to life or property. Due to the low energy of radionuclides used in nuclear 

6 medicine departments for diagnostic studies, a description of adjacent areas is unnecessary. 

7 However, if PET radionuclides are used, a description of the specialized PET facilities should be 

8 provided. The description should include facility diagrams, the shielding installed, specialized 

9 handling equipment, and survey results to ensure that the regulatory limits in 10 CFR 20.1201, 

10 “Occupational dose limits for adults,” and 10 CFR 20.1301, “Dose limits for individual members 

11 of the public,” are met. For therapy facilities, the applicant should demonstrate that the limits 

12 specified in 10 CFR 20.1301(a) will not be exceeded and how access will be controlled in 

13 accordance with 10 CFR 20.1601 and 10 CFR 20.1602. If the facility descriptions or 

14 calculations demonstrate that these limits cannot be met, indicate any further steps that will be 

15 taken to limit exposure to individual members of the public. The applicant may consider adding 

16 shielding to the barrier in question, with corresponding modification of the facility description 

17 if necessary. 

18 Drawings and diagrams that provide the exact location of materials or depict specific locations 

19 of safety or security equipment should be marked as “Security-Related Information – Withhold 

20 Under 10 CFR 2.390.” See Chapter 6, “Identifying and Protecting Sensitive Information.” 

21 For types of use permitted by 10 CFR 35.100 and 35.200, applicants should provide room 

22 numbers for areas in which byproduct materials are used or prepared for use (i.e., “hot labs”). 

23 (See Figure 8-2.) 
8-34 

SECURITY-RELATED INFORMATION – WITHHOLD UNDER 10 CFR 2.390* 

SECURITY-RELATED INFORMATION – WITHHOLD UNDER 10 CFR 2.390* 

*For the purpose of this NUREG, the facility diagram is marked appropriately for an application. 

This particular diagram does not contain real security-related sensitive information 

Figure 8-2. Facility Diagram for Nuclear Medicine Suite 

1 If the applicant uses PET radionuclides under 10 CFR 35.100 or 35.200, the applicant should 

2 provide a description of the imaging rooms, quiet rooms, hot cells (if applicable), and location of 

3 the PET delivery line (if applicable). A discussion of the shielding associated with the PET 

4 facility, including shielding calculations, should also be provided. (See Figure 8-3). AAPM Task 

5 Group 108, “PET and PET/CT Shielding Requirements,” provides guidance on how to design a 

6 PET facility and perform associated shielding calculations. The document also provides 

7 guidance on appropriate safety equipment to use. 
8-35 

SECURITY-RELATED INFORMATION – WITHHOLD UNDER 10 CFR 2.390* 

Suite 301 is on the top floor in the corner of the building 

Suite 302 is occupied by an oncology practice 

Suite 303 is occupied by obstetrics and gynecology practice 

Directly below Suite 301 is a dental practice 

As noted in AAPM Task Group Report 108, 0.65 centimeters (cm) of lead or 7 cm of poured 

concrete in doors, walls, ceiling, and floors of hot lab, quiet rooms, and imaging rooms is 

sufficient to meet the regulatory requirements in 10 CFR 20.1301. 

Assumed work load is 40 patients per week. 

SECURITY-RELATED INFORMATION – WITHHOLD UNDER 10 CFR 2.390* 

*For the purpose of this NUREG, the facility diagram is marked appropriately for an application. This particular 

diagram does not contain real security related sensitive information. 

Figure 8-3. Facility Diagram for PET Suite 

1 For types of use permitted by 10 CFR 35.300 and 35.400, applicants should provide the 

2 locations where sources are stored (e.g., fume hood or shielded cave). The most widely used 

3 source of radiopharmaceutical therapy is I-131 sodium iodide. Since this radionuclide is volatile 

4 in either liquid or capsule form, applicants should consider establishing appropriate radiological 

5 controls. In addition, in accordance with 10 CFR 35.315(a) and 10 CFR 35.415, the applicant 

6 should describe the rooms where patients will be housed, if they cannot be released under 

7 10 CFR 35.75. When patients are treated with I-131 sodium iodide, sources of contamination 

8 include airborne I-131, urine, perspiration, saliva, and other secretions. 
8-36 

1 The discussion should include a description of shielding to ensure that the dose rates in 

2 adjacent areas are in accordance with the regulations. Regulatory requirements, the principle of 

3 ALARA, and access control should be considered when determining the location of the therapy 

4 patient’s room. 

5 If radiopharmaceutical therapy and brachytherapy patient rooms are added after the initial 

6 license is issued, additional room diagrams should be submitted if the room design (including 

7 shielding) and the occupancy of adjacent areas are significantly different from the original 

8 information provided. A written description should be submitted for simple changes. 

9 Note: If applicants are proposing to use portable shielding to protect health and minimize 

10 danger to life or property, they should describe the alternative equipment and administrative 

11 procedures they propose to use for evaluation and approval by the NRC. If applicants elect to 

12 use portable shielding, they should commit to having administrative procedures to control 

13 configuration management to maintain dose within regulatory limits. 

14 For types of use permitted by 10 CFR 35.500, the applicant should provide the room numbers 

15 of use. 

16 For types of use permitted by 10 CFR 35.600 and as required by 10 CFR 35.615, the applicant 

17 should provide a diagram and the shielding calculations for the facility. (See Figure 8-4). 
8-37 

SECURITY-RELATED INFORMATION – WITHHOLD UNDER 10 CFR 2.390* 

Iridium-192 (Ir-192) gamma constant from NCRP Report No. 49: 4.8 roentgen-cm2

h-1mCi-1 

Ir-192 Tenth Value Layer from NCRP Report No. 49: 2 cm lead, 14.7 cm poured concrete 

2 ft of concrete assumes 20 min beam on-time per hour (h) and 1 ft minimum distance from 

each wall; 10 ft from the door; maximum loading 12 Ci 

SECURITY-RELATED INFORMATION – WITHHOLD UNDER 10 CFR 2.390* 

*For the purpose of this NUREG, the facility diagram is marked appropriately for an application. This particular 

diagram does not contain real security-related sensitive information.

Figure 8-4. Facility Diagram for HDR Suite 

1 When preparing applications for use under 10 CFR 35.1000, applicants should review the 

2 guidance on the Medical Uses Licensee Toolkit to determine the type of information appropriate 

3 to evaluate the adequacy of the facilities. 

4 All limited specific medical use licensees are required by 10 CFR 35.13, “License amendments,” 

5 to obtain a license amendment before adding to or changing an area of use identified in the 

6 application or on the license. However, changes and additions to the 10 CFR 35.100 and 

7 35.200 medical use areas located in the same address of use do not require a license 

8 amendment and can be made, provided the NRC is notified as required by 10 CFR 35.14 within 

9 30 days following the changes. The broad scope medical use licensee does not have to notify 

10 NRC of changes that do not require a license amendment. 
8-38 

1 Response from Applicant: All medical use applicants, including broad scope medical use 

2 applicants, are required to provide facility diagrams. The applicant should follow the guidance in 

3 Chapter 6, “Identifying and Protecting Sensitive Information,” to determine if the response 

4 includes security-related sensitive information and needs to be marked accordingly. Provide 

5 the following: 

6  Facility diagrams. Drawings should be to scale, or the scale used should be indicated. 

7  Location, room numbers, and principal use of each room, including patient treatment 

8 rooms, or area where byproduct material is prepared, used, or stored. 

9  Shielding calculations, including information about the type, thickness, and density of 

10 any necessary shielding to enable independent verification of shielding calculations, and 

11 a description of any portable shields used (e.g., shielding of proposed patient rooms 

12 used for implant therapy, including the dimensions of any portable shield, if one is used; 

13 source storage safe). The calculations should include the workload assumptions used. 

14  For radiopharmaceutical and sealed source therapies, provide a description of 

15 surrounding areas, including the occupancy factors, and indicate whether the areas are 

16 restricted or unrestricted, as defined in 10 CFR 20.1003. 

17  For teletherapy facilities, applicants should provide the directions of primary beam use 

18 for teletherapy units and, in the case of an isocentric unit, the plane of beam rotation. 

19  For 10 CFR 35.1000 (e.g., Perfexion, View-Ray), applicants should provide information 

20 described in the guidance on the Medical Uses Licensee Toolkit. 

21 References and Resources: 

22  National Council on Radiation Protection and Measurements (NCRP) Report No. 40, 

23 “Protection against Radiation from Brachytherapy Sources,” 1972. 

24  NCRP Report No. 49, “Structural Shielding Design and Evaluation for Medical Use of 

25 X-Rays and Gamma Rays of Energies up to 10 MeV,” 1976. 

26  NCRP Report No. 102, “Medical X-Ray, Electron Beam and Gamma-Ray Protection for 

27 Energies up to 50 MeV (Equipment Design, Performance and Use),” 1989. 

28  NCRP Report No. 151 “Structural Shielding Design and Evaluation for Megavoltage 

29 X- and Gamma-Ray Radiotherapy Facilities,” 2005. 

30  AAPM Task Group 108, “PET and PET/CT Shielding Requirements,” 2006.

31 8.9.2 Radiation Monitoring Instruments 

32 Regulations: 10 CFR 20.1101, 10 CFR 20.1501, 

33 10 CFR 30.33(a)(2), 10 CFR 35.61

34 Criteria: All licensees shall possess calibrated radiation detection 

35 and measuring instruments that will be used for radiation protection, 

36 including survey and monitoring instruments and quantitative 

37 measuring instruments needed to monitor the adequacy of 

38 radioactive materials containment and contamination control. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-39 

1 Discussion: The radiation protection program that licensees are required to develop, 

2 document, and implement in accordance with 10 CFR 20.1101 must include provisions for 

3 survey instrument calibration (10 CFR 20.1501). Licensees shall possess instruments used to 

4 measure radiation levels, radioactive contamination, and radioactivity, as applicable. 

5 Instruments used for quantitative radiation measurements must be calibrated for the radiation 

6 measured. The instruments should be available for use at all times when byproduct material is 

7 in use. The licensee should possess survey instruments sufficiently sensitive to measure the 

8 type and energy of radiation used, including survey instruments used to locate low-energy or 

9 low-activity seeds [e.g., iodine-125 (I-125), palladium-103] if they become dislodged in the 

10 operating room or patient’s room (e.g., NaI instruments). 

11 For the purposes of this document, radiation monitoring instruments are defined as any device 

12 used to measure the radiological conditions at a licensed facility. Some of the 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  area monitors 

17  single or multichannel analyzers 

18  liquid scintillation counters 

19  gamma counters 

20  proportional counters 

21  solid state detectors 

22  hand- and foot-contamination monitors 

23 It is not necessary for a licensee to possess a radiation survey meter solely for sealed source 

24 use under 10 CFR 35.500, but a radiation survey meter should be available on short notice in 

25 the event of an accident or emergency involving the sealed source. 

26 Radiation survey meter calibrations must be performed by persons, including licensed 

27 personnel, who are qualified to perform calibrations. One method a licensee may use to 

28 determine if the service vendor is qualified to perform these activities is to determine that it has 

29 an NRC (or an equivalent Agreement State) license. Alternatively, an applicant may choose to 

30 develop, implement, and maintain procedures to ensure instruments are calibrated, or propose 

31 an alternate method for calibration. Regardless of whether an applicant is authorized to 

32 calibrate radiation survey meters or contracts an authorized vendor to perform calibrations, the 

33 licensee must retain records of the calibration of instruments and equipment used for 

34 quantitative radiation measurements for 3 years after the record is made in accordance with 10 

35 CFR 20.2103(a). 

36 Appendix K of this NUREG provides guidance regarding appropriate instrumentation and model 

37 survey instrument calibration procedures if the licensee requests to perform in-house calibration 

38 of their own radiation survey meters to meet the requirements detailed in 10 CFR 35.61, 

39 “Calibration of survey instruments.” 

40 Response from Applicant: Provide the following: 

41  A statement that: “Radiation monitoring instruments will be calibrated by a vendor who 

42 is licensed by the NRC or an Agreement State to perform instrument calibrations.” 

43 AND/OR 
8-40 

1  A statement that: “We have developed and will implement and maintain written radiation 

2 survey meter calibration procedures in accordance with the requirements in 

3 10 CFR 20.1501 and that meet the requirements in 10 CFR 35.61.” 

4 AND 

5  A description of the instrumentation (e.g., gamma counter, solid state detector, portable 

6 or stationary count rate meter, portable or stationary dose rate or exposure rate meter, 

7 single or multichannel analyzer, liquid scintillation counter, proportional counter) that will 

8 be used to perform required surveys. 

9 Note: A licensee reserves the right to upgrade survey instruments as necessary as long as 

10 they are adequate to measure the type and level of radiation for which they are used. 

11 8.9.3 Dose Calibrator and Other Equipment Used to Measure Dosages of 

12 Unsealed Byproduct Material 

13 Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.60, 10 CFR 35.63 

14 Criteria: In 10 CFR 35.60, “Possession, use, and calibration of 

15 instruments used to measure the activity of unsealed byproduct 

16 material,” and 10 CFR 35.63, “Determination of dosages of unsealed 

17 byproduct material for medical use,” the NRC describes 

18 requirements for the use, possession, calibration, and check of 

instruments (e.g., dose5 19 calibrators) used to measure 

20 patient dosages. 

21 Discussion: As described in 10 CFR 35.63, dosage measurement 

22 is required for licensees who prepare patient dosages. 

23 If the licensee uses only unit dosages made by a manufacturer or preparer licensed under 

24 10 CFR 32.72, “Manufacture, preparation, or transfer for commercial distribution of radioactive 

25 drugs containing byproduct material for medical use under part 35,” or a PET radioactive drug 

26 producer authorized under 10 CFR 30.32(j) (and does not split, combine, or otherwise modify 

27 unit dosages), the licensee is not required to possess an instrument to measure the dosage. 

28 Furthermore, licensees may rely on the provider’s dose label for the measurement of the 

29 dosage and decay-correct the dosage to the time of administration. 

30 If the licensee performs direct measurements of dosages in accordance with 10 CFR 35.63

31 (e.g., prepares its own dosages, breaks up unit dosages for patient administration, or decides to 

32 measure unit dosages), the licensee is required to possess and calibrate all instruments used 

33 for measuring patient dosages. See Appendix G of this NUREG. 

34 Equipment used to measure dosages must be calibrated in accordance with nationally 

35 recognized standards [e.g., American National Standards Institute (ANSI)] or the manufacturer’s 

 

5

NRC introduced the term, “dosage,” in the 2002 revision of 10 CFR Part 35 with the new definition of prescribed 

dosage in an effort to replace the previous term, “dose,” which also refers to the amount of energy absorbed per unit 

mass. However, NRC understands “dose” continues to be used by many medical professionals to refer to the activity

of unsealed byproduct material, hence the name dose calibrator. 

Part 35 Applicability

100 ✓* 

200 ✓* 

300 ✓* 

400 

500 

600 

1000 ✓* 

*If applicant will measure 

patient dosages or use other 

than unit dosages 
8-41 

1 instructions. The measurement equipment may be a well-type ionization chamber, a liquid 

2 scintillation counter, etc., as long as the instrument can be calibrated appropriately for the type 

3 and energy of radiation emitted and is both accurate and reliable. 

4 For other than unit dosages, the activity must be determined by direct measurement, by a 

5 combination of radioactivity measurement and mathematical calculation, or by a combination of 

6 volumetric measurement and mathematical calculation. However, there are inherent technical 

7 difficulties to overcome. For beta-emitting radionuclides, these difficulties include dependence 

8 on geometry, lack of an industry standard for materials used in the manufacture of vials and 

9 syringes, and lack of an NIST-traceable standard for some radionuclides used. For instance, 

10 when determining the dosage of phosphorus-32, assays with a dose calibrator may result in 

11 inaccuracies caused by inherent variations in geometry; therefore, a volumetric measurement 

12 and mathematical calculation may be more accurate. Licensees must assay patient dosages in 

13 the same type of vial and geometry as used to determine the correct dose calibrator settings. 

14 Using different vials or syringes may result in measurement errors due, for example, to the 

15 variation of bremsstrahlung created by interaction between beta particles and the differing 

16 dosage containers. Licensees are reminded that beta emitters should be shielded using a 

17 low-atomic-numbered material to minimize the production of bremsstrahlung. When a 

18 high-activity source is involved, consideration should be given to adding an outer shield made 

19 from material with a high atomic number to attenuate bremsstrahlung. 

20 The inherent technical difficulties in measuring alpha-emitting radionuclides are even greater 

21 than those of measuring beta emissions. In the absence of an additional photon, gamma, or 

22 beta particle emission that can be measured with traditional instrumentation used in nuclear 

23 medicine (e.g., ion chambers) and quantified in relation to the alpha particle emissions, most 

24 alpha measuring instruments (e.g., gas proportional counters and liquid scintillation counters) 

25 will require preparation and measurement of an aliquot of the unsealed byproduct material. 

26 Measurement of aliquots introduces additional uncertainties associated with removing precise 

27 and reproducible volumes from homogeneous samples. For example, NRC issued Information 

28 Notice (IN) 2016-03, “Revision to the National Institute of Standards and Technology Standard 

29 for Radium-223 and Impact on Dose Calibration for the Medical Use of Radium-223 Dichloride,” 

30 October 23, 2015, to notify licensees of a correction in measuring radium-223, which is primarily 

31 an alpha-emitter. To avoid these difficulties, the best method is to use unit dosages and the 

32 manufacturer’s or commercial nuclear pharmacy’s dose label for measurement of the dosage 

33 and decay-correct the dosage to the time of administration. These difficulties can also be 

34 avoided when not using unit dosages by relying on the provider’s dose label for measurement of 

35 the radioactivity and a combination of volumetric measurement and mathematical calculation. 

36 Licensees who use rubidium-82 (Rb-82)/strontium-82 (Sr-82) generators should refer to the 

37 following for further guidance on the measurement of dosages: 

38  RIS 2013-12, “Notice of Issuance of Enforcement Guidance Memorandum—Interim 

39 Guidance for Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for the 

40 Calibration of Instrumentation to Measure the Activity of Rubidium-82 and the 

41 Determination of Rubidium-82 Patient Dosages,” August 23, 2013 

42  Enforcement Guidance Memorandum – Interim Guidance for Dispositioning Violations 

43 Involving 10 CFR 35.60 and 10 CFR 35.63 for the Calibration of Instrumentation to 

44 Measure the Activity of Rubidium-82 and the Determination of Rubidium-82 Patient 

45 Dosages
8-42 

1 Response from Applicant, if Applicable: 

2 For the administration of alpha-, gamma- and beta-emitting unsealed byproduct materials, 

3 provide the following: 

4 A statement that: “Equipment used to measure dosages will be calibrated in accordance with 

5 nationally recognized standards or the manufacturer’s instructions.” 

6 AND 

7 A description of the equipment used to measure the dosages. 

8 Note: For alpha-emitters where gamma or beta emissions are not measureable, licensees 

9 should identify the nationally recognized standard used to calibrate the instrument or provide a 

10 copy of the manufacturer’s instructions to calibrate the instrument. 

11 8.9.4 Therapy Unit – Calibration and Use 

12 Regulations: 10 CFR 30.33(a)(2), 10 CFR 35.12(c)(2), 

13 10 CFR 35.432, 10 CFR 35.433, 10 CFR 35.630, 10 CFR 35.632, 

14 10 CFR 35.633, 10 CFR 35.635, 10 CFR 35.642, 10 CFR 35.643, 

15 10 CFR 35.645, 10 CFR 35.652. 

16 Criteria: The above regulations contain NRC requirements, 

17 including recordkeeping requirements, for verification and periodic 

18 spot-checks of source activity or output. To perform these 

19 measurements, the applicant must possess appropriately calibrated 

20 dosimetry equipment. For manual brachytherapy sources and low21 dose-rate (LDR) remote afterloader sources, licensees may use 

22 source activity or output determined by the manufacturer, provided 

23 that the manufacturer’s measurements meet applicable 

24 requirements. 

25 Discussion: Except for manual brachytherapy sources and LDR remote afterloader sources, 

26 where the source output or activity is determined by the manufacturer, the applicant must 

27 possess a calibrated dosimetry system (e.g., Farmer chamber, electrometer, well-type ionization 

28 chamber) that will be used to perform calibration measurements of sealed sources to be used 

29 for patient therapy. In accordance with 10 CFR 35.432, if the manual brachytherapy source 

30 output or activity is not determined by the manufacturer, the licensee must perform a calibration 

31 prior to medical use. Dosimetry systems and sealed sources used to calibrate the licensee’s 

32 dosimetry systems must be traceable to NIST or to a laboratory accredited by AAPM, pursuant 

33 to 10 CFR 35.630, “Dosimetry equipment.” The licensee must maintain records of calibrations 

34 of dosimetry equipment for the duration of the license. 

35 The licensee’s AMP must perform full calibrations of sealed sources and devices used for 

36 therapy in accordance with published protocols currently accepted by nationally recognized 

37 bodies (e.g., AAPM, American College of Radiology, ANSI). Calibration by an AMP is not 

38 required for manual brachytherapy sources, except for calculating the activity of Sr-90 sources. 

39 In accordance with 10 CFR 35.433, the licensee’s AMP must calculate the activity of each Sr-90 

40 source that is used to determine the treatment times for ophthalmic treatments. 

Part 35 Applicability

100 

200 

300 

400 ✓* 

500 

600 ✓* 

1000 ✓

*Special requirements re: 

brachytherapy and LDR 

afterloader sources and 

Sr-90 sources. 
8-43 

1 In addition, the licensee must perform spot-check measurements of sealed sources and devices 

2 used for therapy, in accordance with written procedures established by the AMP 

3 (10 CFR 35.642, 10 CFR 35.643, and 10 CFR 35.645). These procedures must be submitted in 

4 accordance with 10 CFR 35.12(c)(2). Calibration procedures described by the AAPM or any 

5 published protocol approved by a nationally recognized body, as applicable, may be used. See 

6 Appendix H of this NUREG for model procedures for performing spot-checks of remote 

7 afterloader devices. 

8 The calibration procedures should address, in part, the method used to determine the exposure 

9 rate (or activity) under specific criteria (i.e., distances used for the measurement, whether the 

10 measurement is an “in air” measurement or done using a phantom configuration of the 

11 chamber with respect to the source(s) and device, scatter factors used to compute the exposure 

12 rate, etc.). 

13 Licensees must perform full calibrations before first medical use, whenever spot-check 

14 measurements (if required) indicate that the output differs by more than 5 percent (%) from the 

15 output obtained at the last full calibration corrected mathematically for decay, following 

16 replacement of the sources or reinstallation of the unit in a new location not previously 

17 described in the license, following any repairs of the unit that include removal of sealed sources 

18 or major repair of the components associated with the source exposure assembly, and at 

19 intervals as defined in 10 CFR 35.632, 10 CFR 35.633, and 10 CFR 35.635. Manual 

20 brachytherapy sources must be calibrated only initially, prior to use. 

21 For sealed sources used in therapy, and in particular, for new types of use, licensees should 

22 select dosimetry equipment that will accurately measure the output or the activity of the source. 

23 In accordance with 10 CFR 35.652, licensees must perform surveys around therapy devices to 

24 ensure that the maximum radiation levels and the average radiation levels from the surface of 

25 the main source safe with the sources in the shielded position do not exceed the levels stated in 

26 the SSD registry. 

27 Response from Applicant: Provide the following: 

28 The applicant must provide the procedures required by 10 CFR 35.642, 10 CFR 35.643, and 

29 10 CFR 35.645, if applicable to the license application. 

30 References and Resources:

31  AAPM Task Group No. 21, “A Protocol for the Determination of Absorbed Dose from 

32 High Energy Photon and Electron Beams,” 1984. 

33  AAPM Report No. 46, “Comprehensive QA for Radiation Oncology, (Radiation Therapy 

34 Committee Task Group No. 40),” 1994. 

35  AAPM Report No. 54, “Stereotactic Radiosurgery,” 1995. 

36  AAPM Report No. 59, “Code of Practice for Brachytherapy Physics, (Radiation Therapy 

37 Committee Task Group No. 56),” 1997. 

38  AAPM Report No. 61, “High Dose Rate Brachytherapy Treatment Delivery, 

39 (Radiation Therapy Committee Task Group No. 59),” 1998. 
8-44 

1  AAPM Report No. 67, “Protocol for Clinical Reference Dosimetry of High-Energy Photon 

2 and Electron Beams, Medical Physics 26(9), pp. 1847-1870, (Radiation Therapy 

3 Committee Task Group No. 51),” September, 1999. 

4  AAPM Report No. 68, “Permanent Prostate Seed Implant Brachytherapy, (AAPM Task 

5 Group No. 64),” October 1999. 

6  AAPM Report No. 84, “Update of AAPM Task Group No. 43 Report: A Revised AAPM 

7 Protocol for Brachytherapy Dose Calculations,” March 2004. 

8  Erratum: “Supplement to the 2004 update of the AAPM Task Group No.43 Report,” 

9 December 2004. 

10  AAPM Report No. 84S, “Supplement to the 2004 Update of the AAPM Task Group No. 

11 43 Report,” June 2007. 

12  NCRP Report No. 69, “Dosimetry of X-Ray and Gamma-Ray Beams for Radiation 

13 Therapy in the Energy Range 10 keV to 50 MeV,” 1981. 

14 8.9.5 Other Equipment and Facilities 

15 Regulations: 10 CFR 20.1101, 10 CFR 20.1901, 10 CFR 20.1902, 

16 10 CFR 30.33(a)(2), 10 CFR 35.12, 10 CFR 35.415, 10 CFR 35.615

17 Criteria: Facilities and equipment must be adequate to protect 

18 health and minimize danger to life or property. 

19 Discussion: Applicants must describe the proposed facilities and 

20 equipment as required by 10 CFR 30.33(a)(2) and 10 CFR 35.12. 

21 The applicant should describe, in Item 9 of the application, any other 

22 proposed equipment and facilities available for safe use and storage 

23 of byproduct material listed in Item 5 of this application. In accordance with 10 CFR 20.1901

24 and 10 CFR 20.1902, the applicant should ensure that the facilities include the appropriate 

25 caution signs and postings. For uses authorized by 10 CFR 35.400, 35.600, and 35.1000, as 

26 applicable, applicants are required to provide a description of emergency response equipment. 

27 In addition, the items below describe other necessary radiation safety equipment. 

28 For PET radionuclide use: The applicant should focus on remote handling devices and 

29 storage containers that may be needed when handling and storing the higher energy emissions 

30 of these materials. 

31 For radiopharmaceutical therapy: The applicant should focus on facilities to be used for 

32 radioactive drug therapy administration and patient accommodations described in Section 8.9.1 

33 (e.g., private room with private bath). The most widely used source of radiopharmaceutical 

34 therapy is I-131 sodium iodide. If the radionuclide is administered in volatile liquid form, it is 

35 important to place the patient dosage in a closed environment (e.g., a fume hood). Also note 

36 there are hazards associated with volatile iodine in capsule form; applicants should consider 

37 this in establishing their radiological controls. When patients are treated with I-131 sodium 

38 iodide, sources of contamination include airborne I-131, urine, perspiration, saliva, and 

39 other secretions. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-45 

1 For manual brachytherapy: The applicant should describe emergency response equipment in 

2 accordance with 10 CFR 35.415. 

3 For teletherapy, GSR, and HDR facilities: The applicant should focus on facilities and 

4 equipment required by 10 CFR 35.615:

5  Appropriate radiation monitors to be used by any individual entering the treatment room 

6 to ensure that radiation levels have returned to ambient levels. One method of meeting 

7 this requirement is a beam-on radiation monitor permanently mounted in each therapy 

8 treatment room that is equipped with an emergency power supply separate from the 

9 power supply for the therapy unit. Such beam-on monitors can provide a visible 

10 indication (e.g., flashing light) of an exposed or partially exposed source. 

11  A system for continuous observation of the patient while the patient is in the treatment 

12 room. If a shielded viewing window will be used, the thickness, density, and type of 

13 material used should be specified. If a closed-circuit television system (or some other 

14 electronic system) will be used to view the patient, the backup system or procedure to be 

15 used in case the electronic system malfunctions should be specified, or the applicant 

16 must commit to suspending all treatments until the electronic system is repaired and 

17 functioning again. 

18  A system for communication with the patient in the event of medical difficulties. An open 

19 microphone system can be used to allow communication without requiring a patient to 

20 move to activate controls. 

21  An electrical interlock system to control the on-off mechanism of the therapy unit. The 

22 interlock system must cause the source(s) to be shielded if the door to the treatment 

23 room is opened when the source is exposed. The interlock system must also prevent 

24 the operator from initiating a treatment cycle unless the treatment room entrance door is 

25 closed. Further, the interlock must be wired so that the source(s) cannot be exposed 

26 after interlock interruption until the treatment room door is closed and the on-off control 

27 for the source(s) is reset at the console. 

28 For pulsed dose-rate (PDR) remote afterloaders: The applicant should focus on the alarm 

29 system because of the unique characteristics and the lack of constant surveillance of their 

30 operation. A more sophisticated alarm system is essential to ensure the patient is protected 

31 during treatment. In addition to the above, consider the following: 

32  The PDR device control console is not accessible to unauthorized personnel 

33 during treatment. 

34  A primary care provider checks the patient to ensure that the patient’s device has not 

35 been moved, kinked, dislodged, or disconnected. 

36  A more sophisticated interlock/warning system is normally installed for PDR devices. 

37 This system should perform the following functions or possess the following 

38 characteristics: 

39 — The signal from the PDR device and the signal from the room radiation monitor 

40 should be connected in such a manner that an audible alarm sounds if the room 

41 monitor indicates the presence of radiation and the device indicates a “safe” or 

42 retracted position. 
8-46 

1 — The alarm circuit should also be wired in such a manner that an audible alarm is 

2 generated for any device internal error condition that could indicate the 

3 unintended extension of the source. This would constitute a circuit that 

4 generates the audible alarm when either the “source retracted and radiation 

5 present” or the appropriate internal error condition(s) exists. 

6 — The “source safe and radiation present” signal should also be self-testing. If a 

7 “source not safe” input is received without a corresponding “radiation present” 

8 signal, the circuit should generate an interlock/warning circuit failure signal that 

9 will cause the source to retract. Reset this circuit manually before attempting to 

10 continue treatment. 

11 — The audible alarm should be sufficiently loud to be clearly heard by the facility’s 

12 responsible device/patient monitoring staff at all times. 

13 — No provisions for bypassing this alarm circuit or for permanently silencing the 

14 alarm should be made to the circuit as long as the room radiation monitor is 

15 indicating the presence of radiation. If any circuitry is provided to mute the 

16 audible alarm, such circuitry should not mute the alarm for a period of more than 

17 1 minute. Controls that disable this alarm circuit or provide for silencing the 

18 alarm for periods in excess of 1 minute should be prohibited. 

19 If the alarm circuit is inoperative for any reason, licensees should prohibit further treatment of 

20 patients with the device until the circuit has been repaired and tested. If the alarm circuit fails 

21 during the course of a patient treatment, the treatment in progress may continue as long as 

22 continuous surveillance of the device is provided during each treatment cycle or fraction. 

23 For LDR remote afterloaders: The applicant should describe how the patient and device will 

24 be monitored during treatment to ensure that the sources and catheter guide tube are not 

25 disturbed during treatment and to provide for prompt detection of any operational problems with 

26 the LDR device during treatment. 

27 For LDR and PDR remote afterloaders: The applicant may submit information on alternatives 

28 to fixed shielding as part of their facility description. This information must demonstrate that the 

29 shielding will remain in place during the course of patient treatment. 

30 Response from Applicant: Follow the guidance in Chapter 6, “Identifying and Protecting 

31 Sensitive Information,” to determine if the response to this section includes security-related 

32 sensitive information and needs to be marked accordingly. 

33 For PET radionuclide use and radiopharmaceutical therapy programs describe the additional 

34 equipment for these uses. 

35 For manual brachytherapy facilities, provide a description of the emergency 

36 response equipment. 

37 For teletherapy, GSR, and remote afterloader facilities, provide a description of the following: 

38  warning systems and restricted area controls (e.g., locks, signs, warning lights and 

39 alarms, interlock systems) for each therapy treatment room 
8-47 

1  area radiation monitoring equipment 

2  viewing and intercom systems (except for LDR units) 

3  steps that will be taken to ensure that no two units can be operated simultaneously, if 

4 other radiation-producing equipment (e.g., linear accelerator, X-ray machine) is in the 

5 treatment room 

6  methods to ensure that whenever the device is not in use or is unattended, the console 

7 keys will be inaccessible to unauthorized persons 

8  emergency response equipment 

9 Reference: 

10  NCRP Report No. 88 - Radiation Alarms and Access Control Systems, 1986

11 8.10 Item 10: Radiation Safety Program

12 Regulations: 10 CFR 20.1101, 10 CFR 30.32, 10 CFR 30.34(e), 

13 10 CFR 35.24, 10 CFR 35.26

14 Criteria: Applicants must develop, document, and implement a 

15 radiation safety program commensurate with the scope of the 

16 licensed activity, in accordance with 10 CFR 20.1101, and submit 

17 portions of that program, when required, to assist in NRC’s review of 

18 the application, in accordance with 10 CFR 30.32. The program 

19 must be sufficient to ensure compliance with the provisions of 10 

20 CFR Part 20 regulations. The licensee is responsible for the conduct 

21 of all licensed activities and the acts and omissions of individuals handling licensed material. 

22 Under 10 CFR 30.34(e), the NRC may incorporate into byproduct materials licenses, at the time 

23 of issuance or thereafter, additional requirements and conditions that it deems appropriate or 

24 necessary to protect health or to minimize danger to life and property. Licensee management’s 

25 authorities and responsibilities for the radiation safety program are described in 10 CFR 35.24, 

26 while 10 CFR 35.26 sets forth four circumstances in which the licensee may revise its radiation 

27 protection program without NRC approval: 

28  The revision does not require a license amendment under 10 CFR 35.13. 

29  The revision is in compliance with the regulations and the license. 

30  The revision has been reviewed and approved by the RSO and licensee management. 

31  The affected individuals are instructed on the revised program before the changes 

32 are implemented. 

33 Discussion: Applicants/licensees must abide by all applicable regulations; develop, implement, 

34 and maintain procedures when required; and provide requested information about the proposed 

35 radiation safety program during the licensing process. Appendix C of this NUREG may be 

36 helpful in determining what information should be provided when requesting a license. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-48 

1 Response from Applicant: Respond to subsequent sections of this document regarding 

2 Item 10 of the application. 

3 Reference: 

4  NCRP Report No. 127, “Operational Radiation Safety Program,” 1998 

5  International Commission on Radiological Protection (ICRP) Report No. 75, “General 

6 Principles for the Radiation Protection of Workers,” 1997 

7 8.10.1 Audit Program 

8 Regulations: 10 CFR 20.1101, 10 CFR 37.33, 10 CFR 37.55 

9 Criteria: Under 10 CFR 20.1101, all licensees must annually review 

10 the content and implementation of the radiation protection program. 

11 The review should ensure the following: 

12  The radiation protection program complies with NRC and 

13 applicable U.S. Department of Transportation (DOT) 

14 regulations and the terms and conditions of the license. 

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

16 Licensees that are subject to the requirements in 10 CFR Part 37 must annually review their 

17 access authorization program and security program. 

18 Discussion: Appendix L of this NUREG contains a suggested annual audit program that is 

19 specific to medical licensees and is acceptable to the NRC. Since all areas indicated in 

20 Appendix L may not be applicable to every licensee and all items may not need to be addressed 

21 during each audit, licensees may wish to develop a program-specific audit checklist. Reviews 

22 or audits of the content and implementation of the radiation protection program must be 

23 conducted at least annually. 

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

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

26 the review or audit programs, licensees should consider including unannounced audits of 

27 authorized and supervised users to observe whether radiation safety procedures are being 

28 followed. 

29 It is essential that once problems are identified, comprehensive corrective actions are taken in a 

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

31 and Implementation of Corrective Action,” dated May 1, 1996, provides guidance on this 

32 subject. The NRC routinely reviews licensee’s records to verify whether appropriate corrective 

33 actions were implemented in a timely manner to address recurrence. It is in the best interest of 

34 the licensee to identify potential violations of regulatory requirements and take necessary steps 

35 to correct them. The NRC can opt to exercise discretion and may elect not to cite the licensee 

36 for these violations if prompt and effective corrective actions are implemented. The NRC’s 

37 Enforcement Policy and Enforcement Manual provide additional information. For examples of 

38 the NRC’s use of discretion in issuing a notice of violation, refer to the most recent version of 

39 NRC’s enforcement documents. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-49 

1 With regard to audit records, 10 CFR 20.2102 requires, in part, that licensees maintain records 

2 of “audits and other reviews of program content and implementation” for 3 years after the record 

3 is made. The NRC has found audit records that contain the following information to be 

4 acceptable: date of audit, name of person(s) who conducted audit, persons contacted by the 

5 auditor(s), areas audited, audit findings, corrective actions, and follow up. 

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.

6 Response from Applicant: No response is necessary. 

7 Reference: 

8  NCRP Report No. 162, “Self Assessment of Radiation-Safety Programs,” 2009 

9 8.10.2 Occupational Dose 

10 Regulations: 10 CFR 19.13, 10 CFR 20.1003, 10 CFR 20.1201, 

11 10 CFR 20.1202, 10 CFR 20.1203, 10 CFR 20.1204, 

12 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1501, 

13 10 CFR 20.1502, 10 CFR 20.1703, 10 CFR 20.2104, 10 CFR 

14 20.2106, 10 CFR 20 Appendix B

15 Criteria: Licensees must evaluate the potential occupational 

16 exposure of all workers and monitor occupational exposure. 

17 

18 The use of individual monitoring devices for external dose is 

19 required, pursuant to 10 CFR 20.1502(a), for: 

20 

21  adults who are likely to receive an annual dose from sources external to the body in 

22 excess of any of the following (each evaluated separately) 

23 — 5 mSv [0.5 rem] deep-dose equivalent 

24 — 15 mSv [1.5 rems] lens (of the eye) dose equivalent 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-50 

1 — 50 mSv [5 rems] shallow-dose equivalent to the skin of the whole body 

2 — 50 mSv [5 rems] shallow-dose equivalent to the skin of any extremity 

3 

4  minors who are likely to receive an annual dose from sources external to the body in 

5 excess of any of the following (each evaluated separately) 

6 

7 — 1.0 mSv [0.1 rem] deep-dose equivalent 

8 — 1.5 mSv [0.15 rem] lens (of the eye) dose equivalent 

9 — 5 mSv [0.5 rem] shallow-dose equivalent to the skin 

10 — 5 mSv [0.5 rem] shallow-dose equivalent to any extremity 

11  declared pregnant women who are likely to receive a dose from radiation sources 

12 external to the body during the entire pregnancy in excess of 1.0 mSv [0.1 rem] deep13 dose equivalent 

14 

15  individuals entering a high or very high radiation area 

16 

17 Internal exposure monitoring is required, pursuant to 10 CFR 20.1502(b), for the following: 

18 

19  adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable 

20 annual limit on intake for ingestion and inhalation 

21  minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 

22 1.0 mSv [0.1 rem] and declared pregnant women likely to receive, during the entire 

23 pregnancy, a committed effective dose equivalent in excess of 1 mSv [0.1 rem] 

24 

25 The licensee must reduce the dose that an individual may be allowed to receive in the current 

26 year by the amount of occupational dose received while employed by any other person, in 

27 accordance with 10 CFR 20.1201(f). 

28 

29 Discussion: Applicants should review the use of all NRC-regulated materials and 

30 State-regulated activities (e.g., x-ray and accelerator operation) when determining, for NRC 

31 requirements, who is an occupationally exposed individual. The definitions in 10 CFR 20.1003

32 define occupational dose, a minor, a declared pregnant woman, and the embryo/fetus of a 

33 declared pregnant woman. 

34 The licensee must evaluate the exposure of all occupational workers (e.g., nurses, 

35 technologists) to determine if monitoring is required to demonstrate compliance with Subpart F 

36 of 10 CFR Part 20. If an adult radiation worker is likely to receive in 1 year a dose greater than 

37 10 percent of any applicable limit (See Figure 8-5 for annual dose limits), monitoring for 

38 occupational exposure is required. Monitoring is required for minors and declared pregnant 

39 females as shown in the criteria section. The licensee should perform an evaluation of the dose 

40 the individual is likely to receive prior to allowing the individual to receive the dose. This 

41 evaluation need not be made for every individual; evaluations can be made for employees with 

42 similar job functions or work areas. 

43 If this prospective evaluation shows that an adult individual’s dose is not likely to exceed 

44 10 percent of any applicable limit, there are no recordkeeping or reporting requirements in 

45 regard to the individual’s exposure. However, the evaluation should be documented. For 

46 individuals who have received doses at other facilities in the current year, the previous dose 

47 need not be considered in this prospective evaluation. Only dose that could be received at the 
8-51 

1 facility performing the evaluation need be considered when determining the need for monitoring, 

2 and therefore, recordkeeping and reporting requirements. If it was determined that monitoring 

3 was not required and a subsequent evaluation shows that the 10 percent threshold has or will 

4 be exceeded, the dose received when monitoring was not provided should be estimated, 

5 recorded, and reported. These estimates can be based on any combination of work location 

6 radiation monitoring or survey results, monitoring results of individuals in similar work situations, 

7 or other estimates to produce a “best estimate” of the actual dose received. The licensees must 

8 also consider the internal and external dose and the occupational workers’ assigned duties 

9 when evaluating the need to monitor occupational radiation exposure and must have a program 

10 in place to sum those exposures in accordance with 10 CFR 20.1202. 

11 

Total effective dose equivalent (TEDE) equals the effective dose equivalent (for external 

exposures) plus the committed effective dose equivalent (for internal exposures). 

Figure 8-5. Annual Occupational Dose Limits for Adults 

12 Licensees should use NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, 

13 “Occupational Dose Record for a Monitoring Period,” to record individual dose. If monitoring is 

14 not required to demonstrate compliance with all limits but is required relative to one or more 

15 specific limits, the licensee should enter “N/A” for “not applicable” in the blocks on NRC Form 4, 

16 “Cumulative Occupational Dose History,” and NRC Form 5, “Occupational Dose Record for a 

17 Monitoring Period,” to indicate the areas for which monitoring was not required (e.g., extremity 

18 or skin doses). Where monitoring was provided but not measurable, the licensee should enter 

19 “ND” for “not detectable.” 

20 If the prospective evaluation shows that the individual adult is likely to exceed 10 percent of an 

21 applicable limit, then monitoring and reporting of the results of monitoring performed, regardless 

22 of the actual dose received, is required. Licensees must provide individual radiation exposure 

23 data to each worker as required by 10 CFR 19.13. 

24 Licensees should also perform prospective evaluations of the doses that may be received by 

25 occupationally exposed minors and declared pregnant women. As with individual adult workers, 

26 licensees must supply and require the use of individual monitoring devices to monitor external 
8-52 

1 exposures and monitor the occupational intake of radioactive material when the results of 

2 prospective dose evaluations exceed the doses specified in 10 CFR 20.1502. 

3 

4 When evaluating an external dose from xenon gas, the licensee may take credit for the 

5 reduction of dose resulting from the use of xenon traps. Additionally, periodic checks of the trap 

6 effluent may be used to ensure proper operation of the xenon trap. Licensees may vent xenon 

7 gas directly to the atmosphere as long as the effluent concentration is within 10 CFR Part 20

8 limits. 

9 When evaluating doses from aerosols, licensees may take credit for the reduction of dose 

10 resulting from the use of aerosol traps. Licensees may vent aerosols directly to the atmosphere 

11 as long as the effluent concentration is within 10 CFR Part 20 limits. 

12 Appendix M of this NUREG provides model procedures for monitoring external occupational 

13 exposure. If external dose monitoring is necessary, the applicant should evaluate the type of 

14 personnel dosimetry, such as film badges, optically stimulated luminescence dosimeters, and 

15 thermoluminescent dosimeters (TLD), that personnel will use. If occupational workers handle 

16 licensed material, the licensee should evaluate the need to provide extremity monitors, which 

17 are required if workers are likely to receive a dose in excess of 0.05 Sv [5 rems] shallow-dose 

18 equivalent, in addition to whole body badges. Additionally, applicants should ensure that their 

19 personnel dosimetry program contains provisions that personnel monitoring devices be worn in 

20 such a way that the part of the body likely to receive the greatest dose will be monitored. 

21 Some licensees use self-reading dosimeters in lieu of processed dosimetry. This is acceptable 

22 if the regulatory requirements are met. See ANSI N322, “Inspection and Test Specifications for 

23 Direct and Indirect Reading Quartz Fiber Pocket Dosimeters,” for more information. If pocket 

24 dosimeters are used to monitor personnel exposures, applicants should state the useful range 

25 of the dosimeters, along with the procedures and frequency for their calibration 

26 [10 CFR 20.1501(c)]. 

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. Most licensees use either film badges or TLDs. The 

31 exchange frequency for dosimeters is typically monthly or quarterly. Applicants should consult 

32 with their NVLAP approved processor for its recommendations for exchange frequency and 

33 proper use of the dosimeter. The NIST maintains a directory of laboratories that are 

34 NVLAP-approved. 

35 RG 8.4, “Methods for Measuring Effective Dose Equivalent from External Exposure,” 

36 June 18, 2015, provides guidance for evaluating occupational dose when some exposure is due 

37 to x-rays, and dosimeters are used to measure exposure behind lead aprons and elsewhere. 

38 It may be necessary to assess the intake of radioactivity for occupationally exposed individuals 

39 in accordance with 10 CFR 20.1204 and 20.1502. If internal dose assessment is necessary, the 

40 applicant shall measure the following: 

41  concentrations of radioactive material in air in work areas 

42  quantities of radionuclides in the body 

43  quantities of radionuclides excreted from the body 

44  combinations of these measurements 
8-53 

1 The applicant should describe in its procedures the criteria used to determine the type of 

2 bioassay and the frequencies at which bioassays (both in vivo and in vitro) will be performed to 

3 evaluate intakes. The criteria should also describe how tables of investigational levels are 

4 derived, including the methodology used by the evaluated internal dose assessments (i.e., the 

5 empirical models used to interpret the raw bioassay data). The bioassay procedures should 

6 provide for baseline, routine, emergency, and follow-up bioassays. If a commercial bioassay 

7 service will be used, the applicant should ensure that the service is licensed by the NRC or an 

8 Agreement State for that service or provide an alternative for review. 

9 Acceptable criteria that applicants may use in developing their bioassay programs are outlined 

10 in RG 8.9, “Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay 

11 Program,” July 1993. 

12 For guidance about methodologies for determination of internal occupational dose and 

13 summation of occupational dose, refer to Table 8-2. 

Table 8-2. Guidance on Personnel Monitoring and Bioassay 

Regulatory Guide 8.7, Revision 2 Instructions for Recording and Reporting Occupational 

Radiation Exposure Data 

Regulatory Guide 8.9, Revision 1 Acceptable Concepts, Models, Equations, and 

Assumptions for a Bioassay Program 

Regulatory Guide 8.20, Revision 2 Applications of Bioassay for Radioiodine 

Regulatory Guide 8.25, Revision 1 Air Sampling in the Workplace 

Regulatory Guide 8.34 Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses 

Regulatory Guide 8.36 Radiation Dose to the Embryo/Fetus 

ANSI N13.30-2011 Performance Criteria for Radiobioassay 

Information Notice 2000-10 Recent Events Resulting in Extremity Exposures 

Exceeding Regulatory Limits 

14 Response from Applicant: Provide one of the following statements: 

15 “We will maintain, for inspection by the NRC, documentation demonstrating that unmonitored 

16 individuals are not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502.” 

17 OR 

18 “We will monitor individuals in accordance with the criteria in the section titled, ‘Radiation Safety 

19 Program–Occupational Dose’ in NUREG–1556, Vol. 9, Rev. 3, ‘Consolidated Guidance About 

20 Materials Licenses: Program-Specific Guidance About Medical Use Licensees.’”

21 OR, IN LIEU OF THESE STATEMENTS, 
8-54 

1 Provide a description of an alternative method for demonstrating compliance with the 

2 referenced regulations. 

3 References and Resources: 

4  F. Eckerman, A. B. Wolbarst, and A. C. B. Richardson, “Federal Guidance Report No. 

5 11, Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion 

6 Factors for Inhalation, Submersion, and Ingestion,” Report No. EPA-520/1-88-020, 1988

7  ANSI N322-1997, “Inspection and Test Specifications for Direct and Indirect Reading 

8 Quartz Fiber Pocket Dosimeters.” 

9  NUREG/CR–4884, “Interpretation of Bioassay Measurements,” July 1987. 

10  NCRP Report No. 87, “Use of Bioassay Procedures for Assessment of Internal 

11 Radionuclide Deposition,” February 1987. 

12  NCRP Report No. 124, “Sources and Magnitude of Occupational and Public Exposures 

13 from Nuclear Medicine,” March 1996. 

14  ICRP Report No. 26, “Recommendations of the International Commission on 

15 Radiological Protection,” 1977. 

16  ICRP Publication No. 54, “Individual Monitoring for Intake of Radionuclides by Workers: 

17 Design and Interpretation,” 1987. 

18  ICRP Publication No. 60, “1990 Recommendations of the International Commission on 

19 Radiological Protection,” 1991. 

20  ICRP Publication No. 78, “Individual Monitoring for Internal Exposure of Workers,” 1997. 

21  RG 8.9, Revision 1, “Acceptable Concepts, Models, Equations, and Assumptions for a 

22 Bioassay Program,” July 1993. 

23  RG 8.4, “Methods for Measuring Effective Dose Equivalent from External Exposure,” 

24 June 18, 2015. 

 
8-55 

1 8.10.3 Public Dose 

2 Regulations: 10 CFR 20.1101(d), 10 CFR 20.1301, 

3 10 CFR 20.1302, 10 CFR 20.1801, 10 CFR 20.1802

4 Criteria: Licensees must do the following: 

5  Ensure that licensed material will be used, transported, and 

6 stored in such a way that members of the public will not 

7 receive more than 1 mSv [100 mrem] in a year, and the dose 

8 in any unrestricted area will not exceed 0.02 mSv [2 mrem] in 

9 any one hour from licensed operations [10 CFR 

10 20.1301(a)(1) and (2)]. 

11  Ensure that air emissions of radioactive materials to the environment will not result in 

12 exposures to individual members of the public in excess of 0.1 mSv [10 mrem] [total 

13 effective dose equivalent (TEDE)] in a year from these emissions [10 CFR 20.1101(d)]. 

14  Control and maintain constant surveillance of licensed material that is not in storage and 

15 secure stored licensed material to prevent unauthorized access, removal, or use (10 

16 CFR 20.1801 and 20.1802). 

17 Discussion: Public dose is defined in 10 CFR 20.1003 as “the dose received by a member of 

18 the public from exposure to radiation or to radioactive material released by a licensee, or to any 

19 other source of radiation under the control of a licensee.” Public dose excludes doses received 

20 from background radiation and medical procedures. Whether the dose to an individual is an 

21 occupational dose or a public dose depends on the individual’s assigned duties. It does not 

22 depend on the area (restricted, controlled, or unrestricted) where the individual is when he or 

23 she receives the dose. 

24 10 CFR 20.1302 describes how compliance may be achieved for public dose limits. Public dose 

25 is controlled, in part, by ensuring that licensed material is secure (e.g., located in a locked area) 

26 to prevent unauthorized access or use by individuals coming into the area. Some medical use 

27 devices containing licensed material are usually restricted by controlling access to the keys 

28 needed to operate the devices and/or to keys to the locked storage area. Only AUs and 

29 personnel using byproduct material under their supervision should have access to these keys. 

30 Typical unrestricted areas may include offices, shops, laboratories, areas outside buildings, 

31 property, and nonradioactive equipment storage areas. The licensee does not control access to 

32 these areas for purposes of controlling exposure to radiation or radioactive materials; however, 

33 the licensee may control access to these areas for other reasons, such as security. For areas 

34 adjacent to facilities where licensed material is used or stored, calculations or a combination 

35 of calculations and measurements (e.g., using an environmental TLD), are often used to 

36 show compliance. 

37 The definition of “public dose” in 10 CFR 20.1003 does not include doses received due to 

38 exposure to patients released in accordance with 10 CFR 35.75. Dose to members of the 

39 public in waiting rooms was addressed in Informational Notice (IN) 94-09, “Release of Patients 

40 with Residual Radioactivity from Medical Treatment and Control of Areas Due to Presence of 

41 Patients Containing Radioactivity Following Implementation of Revised 10 CFR Part 20,” 

42 February 1994. The provisions of 10 CFR 20.1301(a) should not be applied to radiation 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-56 

1 received by a member of the general public from patients released under 10 CFR 35.75. If a 

2 patient is released pursuant to 10 CFR 35.75, licensees are not required to limit the radiation 

3 dose to members of the public (e.g., visitors in a waiting room or individuals near a PET “quiet 

4 room”) from a patient to 0.02 mSv [2 mrem] in any one hour. Patient waiting rooms and “quiet 

5 rooms” need only be controlled for those patients not meeting the release criteria in 

6 10 CFR 35.75. 

7 The regulations in 10 CFR 20.1301(c) allow licensees to permit visitors to a patient who cannot 

8 be released under 10 CFR 35.75 to receive a dose greater than 0.1 rem [1 mSv], provided the 

9 dose does not exceed 0.5 rem [5 mSv], and the AU has determined before the visit that it is 

10 appropriate. RIS 2005-24, “Control of Radiation Dose to Visitors of Hospital Patients,” 

11 November 23, 2005, discusses some of the measures that may be used to maintain control and 

12 minimize doses to visitors. RIS 2006-18, “Requesting Exemption from the Public Dose Limits 

13 for Certain Caregivers of Hospital Patients,” August 31, 2006, describes dose limits for 

14 members of the public that are designated as caregivers. Caregiver dose limits may be 

15 established on a case-by-case basis by the licensee. The justification for incurring the exposure 

16 is that it is beneficial, or possibly essential, to the wellbeing of the patient, and may, therefore, 

17 be considered an extension of the patient’s medical treatment. 

18 In assessing the adequacy of facilities to control public dose, licensees should consider the 

19 design factors discussed under “Facility Diagram” in Section 8.9.1 and may find confirmatory 

20 surveys to be useful in assuring compliance with 10 CFR 20.1301.

21 The licensee must control emissions to air of all byproduct material such that the individual 

22 member of the public likely to receive the highest TEDE does not exceed the constraint level in 

23 10 CFR 20.1101(d), “Radiation Protection Programs,” of 0.10 mSv/year (yr) [10 mrem/yr] from 

24 those emissions. If exceeded, the licensee must report this as described in Section 8.10.22 and 

25 Appendix Y of this NUREG and take prompt actions to ensure against recurrence. 

26 Response from Applicant: No response required. 

27 8.10.4 Operating and Emergency Procedures 

28 Regulations: 10 CFR 19.11(a)(3), 

29 10 CFR 20.1101,10 CFR 20.1601, 10 CFR 20.1602, 

30 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1906, , 

31 10 CFR 20.2201-2203, 10 CFR 21.21, 10 CFR 35.12, 10 CFR 35.41, 

32 10 CFR 35.75, 10 CFR 35.310, 10 CFR 35.315, 10 CFR 35.404, 

33 10 CFR 35.406, 10 CFR 35.410, 10 CFR 35.415, 10 CFR 35.610, 

34 10 CFR 35.615, 10 CFR 35.3045, 10 CFR 35.3047, 

35 10 CFR 35.3067, 10 CFR Part 37, 10 CFR 37.21(a), 10 CFR 37.45, 

36 10 CFR 37.49 

37 Criteria: This section summarizes operating and emergency procedures. Many of these 

38 procedures are covered in greater detail in other sections of this document. The regulatory 

39 requirements are listed above for ease of reference by the applicant. In addition, these 

40 procedures must be posted in accordance with 10 CFR 19.11(a)(3). 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-57 

1 The licensee must develop, implement, and maintain specific operating and emergency 

2 procedures sufficient to ensure compliance with 10 CFR 20.1101(a) and applicable sections in 

3 10 CFR Part 35. Operating and emergency procedures must encompass the scope of the 

4 program, which may include the following elements: 

5  Instructions for opening packages containing licensed material (see Section 8.10.9, 

6 “Opening Packages”). 

7  Instructions for using licensed material, operating therapy treatment devices, and 

8 performing routine maintenance on devices containing sealed sources, according to the 

9 manufacturer’s written recommendations and instructions and in accordance with 

10 regulatory requirements (see Section 8.10.7, “Installation, Maintenance, Adjustment, 

11 Repair, and Inspection of Therapy Devices Containing Sealed Sources”). There may be 

12 sources and devices containing NARM that do not have SSD registration certificates. If 

13 these legacy sources or devices have manufacturers’ recommendations or instructions, 

14 they should be followed. These devices and sources are, however, subject to the 

15 standard leak test provisions included in materials licenses. 

16  Instructions for conducting area radiation level and contamination surveys 

17 (see Section 8.10.13, “Area Surveys”). 

18  Instructions for administering licensed material in accordance with the WD 

19 (see Section 8.10.14, “Procedures for Administrations when a Written Directive 

20 Is Required”). 

21  Steps to ensure that patient release is in accordance with 10 CFR 35.75

22 (see Section 8.10.18, “Release of Patients or Human Research Subjects”). 

23  Instructions for calibration of survey and dosage measuring instruments 

24 (see Sections 8.9.2, “Radiation Monitoring Instruments,” and 8.9.3, “Dose Calibrator and 

25 Other Equipment Used to Measure Dosages of Unsealed Byproduct Material.”). 

26  Periodic spot-checks of therapy device units, sources, and treatment facilities 

27 (see Section 8.9.4, “Therapy Unit – Calibration and Use”). 

28  Instructions for radioactive waste management (see Section 8.11, 

29 “Waste Management”). 

30  Steps to take, and whom to contact (e.g., RSO, local officials), when the following has 

31 occurred: (a) leaking or damaged source, (b) device malfunction and/or damage, 

32 (c) licensed material spills, (d) theft or loss of licensed material, or (e) any other incidents 

33 involving licensed material (see Sections 8.10.5, “Spill/Contamination Procedures,” and 

34 8.10.22, “Reporting”). 

35  Steps for source retrieval and access control of damaged sealed source(s) and/or 

36 malfunctioning devices containing sealed source(s) (see Section 8.10.6, “Emergency 

37 Procedures for Therapy Devices Containing Sealed Sources”). 

38  Steps to take if a therapy patient undergoes emergency surgery or dies. 
8-58 

1 The licensee should: 

2  Make operating procedures, including emergency procedures, available to all users 

3 (e.g., post the procedures or the location of procedure storage). 

4  Maintain a current copy of the procedures at each location of use, or, if this is not 

5 practicable, post a notice describing the procedures and state where they may 

6 be examined. 

7  Use, to the extent practical, procedures and engineering controls based on sound 

8 radiation protection principles to achieve occupational doses and doses to members of 

9 the public that are ALARA, in accordance with 10 CFR 20.1101(b). 

10  Secure or control byproduct material at all times. 

11 Additionally, licensees that possess an aggregated Category 1 or Category 2 quantity of 

12 radioactive material, listed in Appendix A to 10 CFR Part 37, must also establish, implement, 

13 and maintain its access authorization program; coordinate, to the extent practicable, with local 

14 law enforcement authorities, for responding to threats to the licensee’s facility; and be able to 

15 monitor, detect without delay, assess, and respond to any unauthorized entries into 

16 security zones. 

17 Discussion: Sealed sources and unsealed byproduct material used for therapy can deliver 

18 significant doses in a short time. The same may be true for high-activity PET 

19 radiopharmaceuticals, if not shielded. Access control to high- and very-high-radiation areas and 

20 the security of licensed material are described in 10 CFR 20.1601, “Control of access to high 

21 radiation areas;” 10 CFR 20.1602, “Control of access to very high radiation areas;” 

22 10 CFR 20.1801, “Security of stored material;” and 10 CFR 20.1802, “Control of Material Not in 

23 Storage.” Unauthorized access to licensed material by untrained individuals could lead to a 

24 significant radiological hazard. Many licensees achieve access control by permitting only 

25 trained individuals to have access to licensed material (e.g., keys, lock combinations, security 

26 badges). Accountability of licensed material may be ensured by conducting physical 

27 inventories, controlling receipt and disposal, and maintaining use records. 

28 If a therapy patient undergoes emergency surgery or dies, it is necessary to ensure the safety of 

29 others attending the patient. As long as the patient’s body remains unopened, the radiation 

30 received by anyone near it is due almost entirely to gamma rays. When an operation or autopsy 

31 is to be performed, there should be an increased awareness of the possible exposure of the 

32 hands and face to relatively intense beta radiation. Procedures for emergency surgery or 

33 autopsy can be found in NCRP Report No. 155, “Management of Radionuclide Therapy 

34 Patients,” December 2006. 

35 Applicants should develop emergency procedures that address a spectrum of incidents 

36 (e.g., major spills, leaking sources, medical events, interlock failures, stuck sources). After its 

37 occurrence becomes known to the licensee, the NRC must be notified when an incident 

38 involving licensed material occurs. Refer to the regulations (10 CFR 20.2201-20.2203, 

39 10 CFR 30.50, 10 CFR 21.21, 10 CFR 35.3045, 10 CFR 35.3047, and 10 CFR 35.3067) for a 

40 description of when notifications are required. 
8-59 

1 Appendix N of this NUREG provides model procedures that are one method for responding to 

2 some types of emergencies. Applicants requesting authorization for licensed activities not 

3 addressed by the model procedures in Appendix N of this NUREG should develop operational 

4 and emergency procedures to address these other activities. 

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.

5 Response from Applicant: No response is necessary. 

6 8.10.5 Spill/Contamination Procedures 

7 Regulations: 10 CFR 20.1101

8 Criteria: Before using licensed material, the licensee must develop, 

9 document, and implement a radiation protection program that 

10 includes proper response to spills of licensed material. 

11 Discussion: The radiation protection program that licensees are 

12 required to develop, document, and implement in accordance with 

13 10 CFR 20.1101 must include provisions for responding to spills or 

14 other contamination events in order to prevent the spread of 

15 radioactive material. Appendix N of this NUREG contains model emergency response 

16 procedures, including model spill procedures. Spill procedures should address all types and 

17 forms of licensed material used and should be posted in restricted areas where licensed 

18 materials are used or stored. The instructions should specifically state the names and 

19 telephone numbers of persons to be notified (e.g., RSO, staff, State and local authorities, and 

20 the NRC, when applicable). Additionally, the instructions should contain procedures for 

21 evacuation of the area, and containment of spills and other releases, as well as appropriate 

22 methods for reentering and decontaminating facilities (when necessary). 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 

500 

600 

1000 ✓
8-60 

1 Response from Applicant: Provide the following statement: 

2 “We have developed and will implement and maintain written procedures for safe response to 

3 spills of licensed material in accordance with 10 CFR 20.1101.” 

4 Reference: 

5  NCRP Report No. 65, “Management of Persons Accidentally Contaminated with 

6 Radionuclides,” 1980

7 8.10.6 Emergency Procedures for Therapy Devices Containing Sealed Sources 

8 Regulations: 10 CFR 35.12(c)(2), 10 CFR 35.610, 10 CFR 35.615

9 Criteria: Before using materials under 10 CFR 35.600, “Use of a 

10 sealed source in a remote afterloader unit, teletherapy unit, or 

11 gamma stereotactic radiosurgery unit,” the applicant must develop, 

12 document, implement, and submit written emergency procedures in 

13 accordance with 10 CFR 35.12(c)(2). Regulations in 

14 10 CFR 35.610, “Safety procedures and instructions for remote 

15 afterloader units, teletherapy units, and gamma stereotactic 

16 radiosurgery units,” require, in part, that written procedures be 

17 developed, implemented, and maintained for responding to an abnormal situation involving a 

18 remote afterloader unit, a teletherapy unit, or a GSR unit. The procedures needed to meet 

19 10 CFR 35.610 must include 

20  instructions for responding to equipment failures and the names of the individuals 

21 responsible for implementing corrective actions 

22  the process for restricting access to and posting of the treatment area to minimize the 

23 risk of inadvertent exposure 

24  the names and telephone numbers of AUs, AMPs, and the RSO to be contacted if the 

25 unit or console operates abnormally 

26 A copy of these procedures must be physically located at the therapy unit console. The 

27 instructions must inform the operator of procedures to be followed if the operator is unable to 

28 place the source(s) in the shielded position, or remove the patient from the radiation field with 

29 controls from outside the treatment room. 

30 Regulations in 10 CFR 35.615, “Safety precautions for remote afterloader units, teletherapy 

31 units, and gamma stereotactic radiosurgery units,” require the physical presence of certain 

32 individuals for therapy units to ensure that safety precautions are appropriately implemented. 

33 The following documents provide useful information regarding physical presence requirements: 

34  IN 2012-08, “High Dose-Rate Remote Afterloader (HDR) Physical Presence 

35 Requirements,” April 10, 2012 

36  RIS 2005-23, “Clarification of the Physical Presence Requirement During Gamma 

37 Stereotactic Radiosurgery Treatments,” October 7, 2005 

Part 35 Applicability

100 

200 

300 

400 

500 

600 ✓

1000 ✓
8-61 

1 Discussion: The applicant must establish and follow written procedures for emergencies that 

2 may occur (e.g., a therapy source fails to retract or return to the shielded position, or a GSR 

3 couch fails to retract). A copy of the manufacturer’s recommendations and instructions should 

4 be given to each individual performing therapy treatments or operating the therapy device. 

5 Practice drills, using nonradioactive (dummy) sources when possible, must be practiced at least 

6 annually and may be conducted more frequently, as needed. The drills should include dry runs 

7 of emergency procedures that cover stuck or dislodged sources and applicators, if applicable, 

8 and emergency procedures for removing the patient from the radiation field. Team practice may 

9 also be important for adequate emergency coordination for such maneuvers as removing a 

10 patient from a malfunctioning GSR unit and manual movement of the patient treatment table. 

11 These procedures, designed to minimize radiation exposure to patients, workers, and the 

12 general public, should address the following points, as applicable to the type of medical use: 

13  When the procedures are to be implemented, such as any circumstance in which the 

14 source becomes dislodged, cannot be retracted to a fully shielded position, or the patient 

15 cannot be removed from the beam of radiation. 

16  The actions specified for emergency source recovery or shielding that primarily consider 

17 minimizing exposure to the patient and health care personnel while maximizing the 

18 safety of the patient. 

19  The step-by-step actions for single or multiple failures that specify the individual(s) 

20 responsible for implementing the actions. The procedures should clearly specify which 

21 steps are to be taken under different scenarios. The procedure should specify situations 

22 in which surgical intervention may be necessary and the steps that should be taken in 

23 that event. 

24  Location of emergency source recovery equipment, specifying what equipment may be 

25 necessary for various scenarios. Emergency equipment should include shielded storage 

26 containers, remote handling tools, and if appropriate, supplies necessary to surgically 

27 remove applicators or sources from the patient and tools necessary for removal of the 

28 patient from the device. 

29  Radiation safety priorities, such as giving first consideration to minimizing exposure to 

30 the patient, usually by removing the patient from the room (rather than using tools to 

31 attempt to return the source to the off position). 

32  Instructing the staff to act quickly and calmly, and to avoid the primary beam of radiation. 

33  Specifying who is to be notified. 

34  Requirements to restrict (lock, as necessary) and post the treatment area with 

35 appropriate warning signs as soon as the patient and staff are out of the treatment room. 

36 Response from Applicant: Provide procedures required by 10 CFR 35.610. 
8-62 

1 8.10.7 Installation, Maintenance, Adjustment, Repair, and Inspection of 

2 Therapy Devices Containing Sealed Sources 

3 Regulations: 10 CFR 20.1101, 10 CFR 30.32, 10 CFR 35.605, 

4 10 CFR 35.655

5 Criteria: Applicants requesting authorization to install, maintain, 

6 adjust, repair, and inspect their own therapy devices containing 

7 sealed sources must develop, document, submit, and implement 

8 those procedures in accordance with 10 CFR 20.1101 and 

9 10 CFR 30.32. In accordance with 10 CFR 35.605, “Installation, 

10 maintenance, adjustment, and repair,” and 10 CFR 35.655, 

11 “Five-year inspection for teletherapy and gamma stereotactic 

12 radiosurgery units,” licensees must ensure that therapy devices containing sealed sources are 

13 installed, maintained, adjusted, repaired, and inspected by persons specifically licensed to 

14 conduct these activities. The above activities should be conducted according to the 

15 manufacturers’ written recommendations and instructions and according to the SSD registry. In 

16 addition, 10 CFR 35.655 requires that teletherapy and GSR units be fully inspected and 

17 serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, 

18 to ensure that the source exposure mechanism functions properly. Maintenance is necessary to 

19 ensure that the device functions as designed and source integrity is not compromised. 

20 Discussion: Maintenance and repair includes installation, replacement, and relocation or 

21 removal of the sealed source(s) or therapy unit that contains a sealed source(s). Maintenance 

22 and repair also includes any adjustment involving any mechanism on the therapy device, 

23 treatment console, or interlocks that could expose the source(s), reduce the shielding around 

24 the source(s), affect the source drive controls, or compromise the radiation safety of the unit or 

25 the source(s). 

26 The NRC requires that maintenance and repair (as defined above) be performed only by 

27 persons specifically licensed by the NRC or an Agreement State to perform such services. 

28 Most licensee employees do not perform maintenance and repair because they do not have the 

29 specialized equipment and technical expertise to perform these activities. Applicants requesting 

30 authorization to possess and use LDR remote afterloaders should review 10 CFR 35.605 before 

31 responding to this item. Regulations in 10 CFR 35.605 allow for an AMP to perform certain 

32 service activities with regard to LDR remote afterloader units. 

33 Response from Applicant: No response is necessary if the licensee contracts with personnel 

34 who are licensed by the NRC or an Agreement State to install, maintain, adjust, repair, and 

35 inspect the specific therapy device possessed by the licensee. However, if the applicant 

36 requests that an employee who is trained by the manufacturer be authorized to perform the 

37 aforementioned activities, the applicant must provide sufficient information to allow the NRC to 

38 evaluate and approve such authorization in accordance with 10 CFR 35.605 and 

39 10 CFR 35.655. This should include the following: 

40  name of the proposed employee and types of activities requested 

41 AND 

42  description of the training and experience demonstrating that the proposed employee is 

43 qualified by training and experience for the use requested 

Part 35 Applicability

100 

200 

300 

400 

500 

600 ✓

1000 ✓
8-63 

1 AND 

2  copy of the manufacturer’s training certification and an outline of the training received 

3 Note: The applicant should specify only those installation, maintenance, inspection, 

4 adjustment, and repair functions, as described in a certificate or letter from the manufacturer of 

5 the device, that document the employee’s training in the requested function(s). 

6 8.10.8 Ordering and Receiving 

7 Regulations: 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1906

8 Criteria: The requirements for receiving packages containing 

9 licensed material are found in 10 CFR 20.1906, “Procedures for 

10 receiving and opening packages.” Additionally, the security of 

11 licensed material, required by 10 CFR 20.1801 and 10 CFR 20.1802, 

12 must be considered for all receiving areas. 

13 Discussion: Licensees must ensure that the type and quantity of 

14 licensed material possessed is in accordance with the license. 

15 Additionally, licensees must ensure that packages are secured and radiation exposure from 

16 packages is minimized. 

17 Appendix O of this NUREG contains model procedures that are one method for ordering and 

18 receiving licensed material. 

19 Response from Applicant: No response is necessary. 

20 8.10.9 Opening Packages 

21 Regulations: 10 CFR 20.1906

22 Criteria: Licensees must ensure that packages are opened safely 

23 and that the requirements of 10 CFR 20.1906 are met. 

24 Discussion: Licensees must establish, maintain, and retain written 

25 procedures for safely opening packages to ensure that the 

26 monitoring requirements of 10 CFR 20.1906 are met and that 

27 radiation exposure to personnel coming near or in contact with the 

28 packages containing radioactive material are ALARA. 

29 Appendix P of this NUREG contains model procedures that represent one method for safely 

30 opening packages containing radioactive materials. Applicants are reminded that 

31 10 CFR 20.1906(b) requires, in part, that licensees monitor the external surfaces of a labeled 

32 package for radioactive contamination within 3 hours of receipt if it is received during normal 

33 working hours, or not later than 3 hours from the beginning of the next working day if it is 

34 received after working hours.

35 Response from Applicant: No response required. 

36 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-64 

1 8.10.10 Material Receipt and Accountability 

2 Regulations: 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 

3 20.2108,10 CFR 20.2201, 10 CFR 20.2207, 10 CFR 30.41, 

4 10 CFR 30.51, 10 CFR 35.67, 10 CFR 35.406, 10 CFR 37.49, 10 

5 CFR 37.71, 10 CFR 37.75, 10 CFR 37.77. 

6 Criteria: To maintain accountability of licensed material, licensees 

7 must do the following: 

8  Secure licensed material. (10 CFR 20.1801 and 10 CFR 20.1802) 

9  Maintain records of receipt, transfer, and disposal of licensed material. (10 CFR 30.51, 

10 10 CFR 30.41, and 10 CFR 20.2108) 

11  Conduct physical inventories at required frequencies to account for licensed material. 

12 Ensure that material received does not exceed license possession limits. 

13  Update transactions in the National Source Tracking System (NSTS), including an 

14 annual inventory reconciliation. [10 CFR 20.2207] 

15  Conduct physical inventories at semi-annual intervals (not to exceed 6 months) to 

16 account for all sealed sources containing byproduct material. (10 CFR 35.67) 

17  Maintain accountability for brachytherapy sources in storage or use. (10 CFR 35.406) 

18  Before transferring aggregated Category 1 or Category 2 quantities of radioactive 

19 material listed in Appendix A to 10 CFR Part 37, use NRC’s license verification system 

20 to verify that the recipient licensee is authorized to possess the radioactive material. 

21  Preplan, coordinate, and provide advance notification of shipment of Category 1 

22 quantities of radioactive material and coordinate shipment of Category 2 quantities of 

23 radioactive material listed in Appendix A to 10 CFR Part 37. (10 CFR 37.75 and 

24 10 CFR 37.77) 

25 Discussion: Licensed materials must be tracked from “cradle to grave,” from receipt (from 

26 another licensee or from its own radionuclide production facility) to its eventual transfer/disposal 

27 in order to ensure accountability; to identify that licensed material is missing and document the 

28 last confirmed possession of the material when it is lost, stolen (10 CFR 20.2201), or misplaced; 

29 and to ensure that possession limits listed on the license are not exceeded. 

30 For aggregated Category 1 and Category 2 quantities of radioactive material, licensees must, in 

31 accordance with 10 CFR 37.49(a)(1), continuously monitor and detect, without delay, all 

32 unauthorized entries into security zones. Additionally, for Category 1 quantities of radioactive 

33 material, 10 CFR 37.49(a)(3)(i) requires immediate detection of any attempted unauthorized 

34 removal of the radioactive material from the security zone. For Category 2 quantities of 

35 radioactive material, 10 CFR 37.49(a)(3)(ii) requires weekly verification through physical 

36 checks, tamper indicating devices, use, or other means to ensure that the radioactive material 

37 is present. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-65 

1 Licensees are required under 10 CFR 20.1801 and 20.1802 to secure radioactive materials 

2 from unauthorized removal or access while in storage and to control and maintain constant 

3 surveillance over licensed material that is not in storage. 

4 Receipt, inventory, transfer, and disposal records must be maintained for the times specified in 

5 Table X–1 in Appendix X of this NUREG. Typically, these records contain the following types of 

6 information: 

7  radionuclide and the activity (in units of becquerels or curies) of byproduct material in 

8 each sealed source 

9  manufacturer’s or distributor’s name, model number, and serial number (if appropriate) 

10 of each device containing byproduct material 

11  location of each sealed source and device 

12  for inventories, the date of the inventory, and name and signature of the individual 

13 conducting the inventory 

 for materials transferred or disposed of, the date of the transfer or disposal, the name 

and license number of the recipient, and a description of the affected radioactive 

material (e.g., radionuclide, activity, manufacturer’s or distributor’s name and model 

number, serial number) 

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. 
8-66 

1 Response from Applicant: 

2  If applicable, provide the following statement: “We will comply with the National Source 

3 Tracking System (NSTS) reporting requirement as described in 10 CFR 20.2207.”

4 8.10.11 Leak Tests 

5 Regulations: 10 CFR 20.1501, 10 CFR 35.67

6 Criteria: The NRC requires testing to determine if there is any 

7 radioactive leakage from sealed sources. The NRC finds testing to 

8 be acceptable if it is conducted by an organization licensed by the 

9 NRC or an Agreement State or if it is conducted in accordance with 

10 procedures submitted by the applicant and approved by the NRC or 

11 an Agreement State. Leak test records shall be retained for 3 years 

12 after they are made or until the source in storage is removed. 

13 Discussion: Licensees must perform leak testing of sealed sources 

14 possessed under 10 CFR Part 35 (e.g., calibration, transmission, 

15 reference, or brachytherapy sources), in accordance with 

16 10 CFR 35.67, “Requirements for possession of sealed sources and brachytherapy sources.” In 

17 addition, licensees must perform leak testing of all other sealed sources possessed under 10 

18 CFR Part 30 (e.g., survey instrument calibration sources), in accordance with 10 CFR 20.1501. 

19 The NRC has regulatory authority over sealed sources and devices containing 

20 accelerator-produced radioactive material and discrete sources of Ra-226, in accordance with 

21 the Energy Policy Act of 2005. There may be sources and devices containing this NARM 

22 byproduct material that do not have SSD registration certificates. These devices and sources 

23 are, however, subject to the standard leak test provisions included in materials licenses. 

24 Appendix Q of this NUREG provides model procedures that are one way to perform leak testing 

25 for sealed sources. Under 10 CFR 35.67, licensees are required to perform leak tests at 

26 6-month intervals or at other intervals approved by the NRC or an Agreement State and 

27 specified in the SSD registration certificate and before first use, unless accompanied by a 

28 certificate indicating that the test was performed within the past 6 months. The measurement of 

29 the leak test sample is a quantitative analysis requiring that instrumentation used to analyze the 

30 sample be capable of detecting 185 Bq [0.005 μCi] of radioactivity on the sample. Leak test 

31 samples should be collected at the most accessible area where contamination would 

32 accumulate if the sealed source were leaking. The leak test may be performed in-house or by a 

33 contractor who is authorized by the NRC or an Agreement State to perform leak tests as a 

34 service to other licensees. 

35 The licensee or contractor does not need to leak-test sources if: 

36  Sources contain only byproduct material with a half-life of less than 30 days. 

37  Sources contain only byproduct material as a gas. 

38  Sources contain 3.7 MBq [100 μCi] or less of beta-emitting or gamma-emitting material, 

39 or 0.37 MBq [10 μCi] or less of alpha-emitting material. 

Part 35 Applicability

100 ✓* 

200 ✓* 

300 ✓* 

400 ✓

500 ✓

600 ✓

1000 ✓

*If possess sealed sources 

under 10 CFR 35.65 
8-67 

1  Sources contain iridium-192 seeds in nylon ribbon. 

2  Sources are stored and not being used. The licensee, shall, however, test each such 

3 source for leakage before any use or transfer unless it has been leak-tested within 

4 6 months before the date of use or transfer. 

5 Response from Applicant: No response is necessary, if leak testing is performed in-house. If 

6 a contractor is used to perform leak testing, the licensee should state the following: 

7 “Leak test sample collection and analysis will be performed by an organization authorized by the 

8 NRC or an Agreement State to provide leak testing services to other licensees; or by using a 

9 leak test sample collection kit supplied by an organization licensed by the NRC or an Agreement 

10 State to provide leak test kits and/or sample analysis services to other licensees and according 

11 to the instructions provided in the leak test sample collection kit.” 

12 8.10.12 Sealed Source Inventory 

13 Regulations: 10 CFR 30.51, 10 CFR 35.67, 10 CFR 35.406

14 Criteria: The NRC requires the licensee in possession of a sealed 

15 source or brachytherapy source to conduct a semi-annual physical 

16 inventory of all such sources in its possession. The licensee must 

17 maintain the inventory records for 3 years. 

18 Discussion: According to 10 CFR 35.67, 10 CFR 35.406, and per 

19 license condition, if applicable (e.g., instrument calibration source), 

20 the licensee must conduct a semi-annual physical inventory of all 

21 sealed sources and brachytherapy sources in its possession. 

22 Individual GSR sources are exempt from this physical inventory 

23 requirement, as stated in 10 CFR 35.67(g). However, under 

24 10 CFR 30.51, the licensee must maintain records of GSR source 

25 receipt, transfer, and disposal to indicate the current inventory of 

26 sources at the licensee’s facility. 

27 Response from Applicant: No response is necessary. 

28 8.10.13 Area Surveys 

29 Regulations: 10 CFR 20.1003, 10 CFR 20.1101, 10 CFR 20.1201, 

30 10 CFR 20.1301, 10 CFR 20.1501, 10 CFR 35.70, 10 CFR 35.315, 

31 10 CFR 35.404, 10 CFR 35.604

32 Criteria: Licensees are required to make surveys of potential 

33 radiological hazards in their workplace. For example, licensees must 

34 perform surveys to 

35  Ensure that licensed material will be used, transported, and 

36 stored in such a way that doses to members of the public do 

37 not exceed 1 mSv/yr [100 mrem/yr] and that the dose in any 

38 unrestricted area will not exceed 0.02 mSv [2 mrem] in any one hour from licensed 

39 operations, in accordance with 10 CFR 20.1301. 

Part 35 Applicability

100 ✓* 

200 ✓* 

300 ✓* 

400 ✓

500 ✓

600 ✓

1000 ✓

*Sealed sources for 

calibration, transmission, 

and reference use (10 CFR 

35.65) 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-68 

1  Ensure that licensed material will be used, transported, and stored in such a way that 

2 occupational doses to individuals will not exceed the limits specified in 10 CFR 20.1201. 

3  Control and maintain constant surveillance over licensed material that is not in storage 

4 and secure licensed material from unauthorized access or removal. 

5  Ensure that licensed material will be used, transported, and stored in such a way that the 

6 air emissions do not exceed the constraint value in 10 CFR 20.1101. 

7 Discussion: The radiation protection program that licensees are required to develop, 

8 document, and implement in accordance with 10 CFR 20.1101 must include provisions for area 

9 surveys. Surveys, as defined in 10 CFR 20.1003, are evaluations of radiological conditions and 

10 potential hazards. These evaluations, as required by 10 CFR 20.1501, may be measurements 

11 (e.g., radiation levels measured with survey instruments or results of wipe tests for 

12 contamination), calculations, or a combination of measurements and calculations. The selection 

13 and proper use of appropriate instruments is one of the most important factors in ensuring that 

14 surveys accurately assess radiological conditions. 

15 There are many different kinds of surveys performed by licensees: 

16  contamination 

17 — fixed 

18 — removable 

19  personnel (during use, transfer, or disposal of licensed material) 

20  air effluent 

21  water effluent 

22  leak test 

23  bioassays 

24  air sample 

25  external radiation exposure levels 

26  restricted areas 

27  unrestricted areas 

28 Surveys are required when it is reasonable under the circumstances to evaluate a radiological 

29 hazard and when necessary for the licensee to comply with the appropriate regulations. The 

30 most important types of surveys are as follows: 

31  surveys for radioactive contamination that could be present on surfaces of floors, walls, 

32 laboratory furniture, and equipment 

33  measurements of radioactive material concentrations in air for areas where 

34 radiopharmaceuticals are handled or processed in unsealed form and where operations 

35 could expose workers to the inhalation of radioactive material (e.g., radioiodine) or 

36 where licensed material is or could be released to unrestricted areas (Refer to RG 8.25, 

37 “Air Sampling in the Workplace,” June 1992, and NUREG–1400, “Air Sampling in the 

38 Workplace,” September 1993, for further guidance on air sampling.) 
8-69 

1  bioassays to determine the kinds, quantities, or concentrations, and in some cases, the 

2 location of radioactive material in the human body. Radioiodine uptake in a worker’s 

3 thyroid gland is commonly measured by external counting using a specialized thyroid 

4 detection probe. 

5  surveys of external radiation exposure levels in both restricted and unrestricted areas 

6  surveys of radiopharmaceutical packages entering (e.g., from suppliers) and departing 

7 (e.g., returned radiopharmaceuticals to the supplier) 

8 The frequency of routine surveys depends on the nature, quantity, and use of radioactive 

9 materials, as well as the specific protective facilities, equipment, and procedures that are 

10 designed to protect workers and the public from external and internal exposure. Also, the 

11 frequency of the survey depends on the type of survey. Appendix R of this NUREG contains 

12 model procedures that represent one acceptable method of establishing survey frequencies for 

13 medical use, ambient radiation levels, and contamination surveys. 

14 For example, in accordance with 10 CFR 35.70, medical use licensees are required to perform 

15 daily surveys in all areas used for the preparation and administration of radiopharmaceuticals 

16 for which a WD is required (diagnostic activities exceeding 1.1 MBq (30 μCi) of I-131 and all 

17 therapy treatments); when the licensee administers radiopharmaceuticals requiring a WD in a 

18 patient’s room, the licensee is not required to perform a survey of the patient’s room. Licensees 

19 should perform surveys after the patient’s release, in accordance with 10 CFR 35.315. 

20 Licensees must perform surveys prior to the release of the room for unrestricted use. Licensees 

21 should be cognizant of the requirement to perform surveys to demonstrate that public dose 

22 limits are not exceeded. 

23 As therapy sealed sources (including applicators, catheters, and therapy sources used for 

24 diagnostic purposes) may become dislodged during implantation or after surgery, and 

25 inadvertently lost or removed, the licensee must perform surveys in accordance with 

26 10 CFR 35.404: 

27  Immediately after implanting sources in a patient or a human research subject, the 

28 licensee shall make a survey to locate and account for all sources that have not 

29 been implanted. 

30  Immediately after removing the last temporary implant source from a patient or human 

31 research subject, the licensee shall make a survey of the patient or human research 

32 subject with a radiation survey instrument to confirm that all sources have 

33 been removed. 

34 In addition, the licensee should also consider the following: 

35  the patient’s bed linens before removing them from the patient’s room 

36  the operating room and the patient’s room after source implantation (e.g., radiation level 

37 and/or visual check) 

38  all trash exiting the patient’s room or surgical recovery room 

39  areas of public access in and around the patient’s room 
8-70 

1 In accordance with 10 CFR 35.604, the licensee must survey patients and the remote 

2 afterloader unit to confirm that the source has been removed from the patient and returned to 

3 the safe shielded position. 

4 Response from Applicant: Provide the following statement: 

5 “We have developed and will implement and maintain written procedures for area surveys in 

6 accordance with 10 CFR 20.1101 that meet the requirements of 10 CFR 20.1501 and 

7 10 CFR 35.70.” 

8 References and Resources:

9  NCRP Report No. 57, “Instrumentation and Monitoring Methods for Radiation 

10 Protection,” 1978. 

11  RG 8.25, “Air Sampling in the Workplace,” June 1992. 

12  NUREG–1400, “Air Sampling in the Workplace,” September 1993. 

13 8.10.14 Procedures for Administrations When a Written 

14 Directive Is Required 

15 Regulations: 10 CFR 35.40, 10 CFR 35.41, 10 CFR 35.457, 

16 10 CFR 35.657

17 Criteria: The requirements for WDs are set forth in 10 CFR 35.40, 

18 “Written directives.” Under 10 CFR 35.41, “Procedures for 

19 administrations requiring a written directive,” medical use licensees 

20 are required to develop, maintain, and implement written procedures 

21 to provide high confidence that licensed material is administered as directed by AUs. 

22 Discussion: A medical use licensee preparing WDs must develop, implement, and maintain 

23 written procedures to provide high confidence that, among other things, each administration is in 

24 accordance with the WD and the patient’s identity is verified. Therefore, licensees should have 

25 checks in place to ensure that the correct patient is treated and each component of the WD is 

26 met. Some licensees’ procedures were developed when the predecessor to 10 CFR 35.41, 

27 called Quality Management Program, was initiated in the 1990s, and licensees may not have 

28 updated these procedures even though administration methods and assessments may have 

29 changed. For instance, prior to 1990, many licensees implanted sources for prostate treatments 

30 without pre-planning or post-planning dosimetry. Today, many licensees perform extensive 

31 imaging and dosimetry to prescribe and evaluate doses to not only intended tissue 

32 (e.g., prostate), but also to nearby tissue (e.g., rectum, bladder, or urethra). Therefore, 

33 licensees are reminded that procedures should correctly document the program currently in 

34 place. For purposes of determining whether medical event reporting is required, licensees 

35 should also provide definitive criteria for evaluating the adequacy of the dose delivered to the 

36 intended treatment site, compared to the prescribed dose, and the acceptability of the dose 

37 delivered to any other organ or tissue, compared to the dose expected from the administration 

38 defined in the written directive. 

Part 35 Applicability

100 

200 

300 ✓

400 ✓

500 

600 ✓

1000 ✓
8-71 

1 Additionally, under 10 CFR 35.457 and 10 CFR 35.657, the licensee must perform acceptance 

2 testing on the treatment planning system of therapy-related computer systems in accordance 

3 with published protocols accepted by nationally recognized bodies. 

4 The procedures do not need to be submitted to the NRC. This gives licensees the flexibility to 

5 revise the procedures to enhance effectiveness without obtaining NRC approval. Appendix S of 

6 this NUREG provides guidance on developing the procedures. 

7 Licensees may find the list of INs summarizing reported medical events in Appendix AA of this 

8 NUREG useful in developing written directive procedures. 

9 Response from Applicant: No response required. 

10 8.10.15 Safe Use of Unsealed Licensed Material 

11 Regulations: 10 CFR 20.1101, 10 CFR 20.1201, 

12 10 CFR 30.33(a)(2)

13 Criteria: Before using licensed material, the licensee must develop 

14 and implement a radiation protection program that includes safe use 

15 of unsealed licensed material. 

16 Discussion: The radiation protection program that licensees are 

17 required to develop, document, and implement in accordance with 

18 10 CFR 20.1101 must include provisions for safe use of licensed 

19 material. Licensees are responsible for developing, documenting, and implementing 

20 procedures to ensure the security and safe use of all licensed material from the time it arrives at 

21 their facilities until it is used, transferred, and disposed of. The written procedures should 

22 provide reasonable assurance that only appropriately trained personnel will handle and use 

23 licensed material without undue hazard to themselves, other workers, or members of the public. 

24 In addition, licensees must develop, implement, and maintain procedures for protective 

25 measures to be taken by occupational workers to maintain their doses ALARA. Protective 

26 measures may include: 

27  use of syringe shields and/or vial shields, specific to the energy emitted 

28 (e.g., PET shields should be used when handling high-energy fluorine-18) 

29  wearing laboratory coats and gloves when handling unsealed byproduct material 

30  monitoring hands after handling unsealed byproduct material 

31  designing equipment and facilities to protect health and minimize danger to life or 

32 property in accordance with 10 CFR 30.33(a)(2)

33 Appendix T of this NUREG contains model procedures that provide one method for the safe use 

34 of unsealed licensed material. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-72 

1 Response from Applicant: Provide the following statement: 

2 “We have developed and will implement and maintain procedures for safe use of unsealed 

3 byproduct material that meet the requirements of 10 CFR 20.1101 and 10 CFR 20.1201.” 

4 8.10.16 Safety Procedures for Treatment When Patients are Hospitalized 

5 Regulations: 10 CFR 20.1201, 10 CFR 20.1301, 10 CFR 20.1501, 

6 10 CFR 20.1801, 10 CFR 35.315, 10 CFR 35.404(b), 

7 10 CFR 35.415, 10 CFR 35.604(a), 10 CFR 35.615, 10 CFR 35.1000

8 Criteria: Applicants must develop and implement procedures to 

9 ensure that access to therapy treatment rooms, and exposure rates 

10 from therapy treatments, are limited to maintain doses to 

11 occupational workers and members of the public within 

12 regulatory limits. 

13 Discussion: Under 10 CFR 35.315, 10 CFR 35.415, 10 CFR 35.615, and 10 CFR 35.1000, 

14 licensees are required to take certain safety precautions for uses of byproduct material involving 

15 radiopharmaceutical therapy, manual brachytherapy, remote afterloader brachytherapy, or 

16 emerging technologies involving patients who cannot be released in accordance with 

17 10 CFR 35.75. The precautions described below are provided to help ensure compliance with 

18 the exposure limits in 10 CFR Part 20. 

19 Under 10 CFR 35.404(b) and 10 CFR 35.604(a), licensees are required to perform a radiation 

20 survey of the patient (and the remote afterloader unit) immediately after removing the last 

21 temporary implant source from the patient and prior to releasing the patient from licensee 

22 control. This is done to confirm that all sources have been removed and accounted for. When 

23 sources are placed within the patient’s body, 10 CFR 35.615(e) requires that licensed activities 

24 be limited to treatments that allow for expeditious removal of a decoupled or jammed source. In 

25 addition, applicants must take the following steps for patients who cannot be released under 

26 10 CFR 35.75: 

27  Provide a room with a private sanitary facility for patients treated with a 

28 radiopharmaceutical therapy dosage. (Note: 10 CFR 35.315(a) allows for a room 

29 shared with another radiopharmaceutical therapy patient.) 

30  Provide a private room for patients implanted with brachytherapy sources. (Note: 

31 10 CFR 35.415 allows for a room shared with another brachytherapy patient.) 

32  Visibly post a “Radioactive Materials” sign on the patient’s room and a note on the door 

33 or in the patient’s chart indicating where and how long visitors may stay in the patient’s 

34 room (10 CFR 35.315 and 10 CFR 35.415). 

35  Either monitor material and items removed from the patient’s room (e.g., patient linens, 

36 surgical dressings) with a radiation survey meter set on its most sensitive scale with no 

37 interposed shielding to determine that their radioactivity cannot be distinguished from the 

38 natural background radiation level or handle them as radioactive waste (10 CFR 35.315

39 and 10 CFR 20.1501). 

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1  Notify the RSO, or his/her designee, and AU as soon as possible if the patient has a 

2 medical emergency or dies (10 CFR 35.315, 10 CFR 35.415, and 10 CFR 35.615). 

3 Licensees are required to perform adequate surveys to evaluate the extent of radiation levels in 

4 accordance with 10 CFR 20.1501. Therefore, licensees must evaluate the exposure rates 

5 around patients who cannot be released under the requirements of 10 CFR 35.75 and are 

6 hospitalized following the dosage administration or implant (e.g., measured exposure rates, 

7 combination of measured and calculated exposure rates). 

8 Licensees are required to secure licensed material in storage from unauthorized access or 

9 removal in accordance with 10 CFR 20.1801. Access control and appropriate training of 

10 authorized personnel may prevent unauthorized removal of licensed material temporarily stored 

11 in the patient’s room and unnecessary personnel exposures. 

12 In order to control exposures to individuals, in accordance with 10 CFR 20.1201 and 

13 10 CFR 20.1301, the licensee should consider briefing patients on radiation safety procedures 

14 for confinement to bed, visitor control, identification of potential problems, notification of medical 

15 staff in the event of problems, and other items as applicable and consistent with good medical 

16 care.

17 Response from Applicant: No response is necessary. 

18 8.10.17 Mobile Medical Service 

19 Regulations: 10 CFR 35.2, 10 CFR 35.80, 10 CFR 35.647, 

20 10 CFR Part 71, 10 CFR 150.20, 49 CFR Parts 171-178

21 Criteria: In addition to the requirements in 10 CFR 35.80 and 

22 10 CFR 35.647, as applicable, mobile medical service licensees 

23 must comply with all other applicable regulations. 

24 Discussion: Applicants for licensure of mobile medical services, as defined in 10 CFR 35.2,

25 should review other sections of this NUREG for information to be submitted as part of their 

26 applications; many other requirements are relevant to the use of byproduct material by mobile 

27 medical service providers, with details being dependent upon the scope of such programs. 

28 “Temporary jobsite” means a location, other than the specific location(s) of use authorized on 

29 the license, where mobile medical services are conducted for limited periods of time. Mobile 

30 medical service licensees may transport licensed material and equipment into a client’s building, 

31 or may bring patients into the transport (e.g., van). In either case, the van should be located on 

32 the client’s property that is under the client’s control. Mobile PET medical service licensees 

33 must consider a “quiet room” as an area of use if the patients in the “quiet room” cannot be 

34 released under the provisions of 10 CFR 35.75. 

35 A self-contained mobile medical service involves a mobile treatment or administration facility 

36 that provides ready-to-deliver mobile medical services on arrival at a client’s site. Companies 

37 providing transportation only will not be licensed for medical use under 10 CFR Part 35. Before 

38 using a remote afterloader for this type of service, the device should be installed in an 

39 appropriately shielded treatment room. 

Part 35 Applicability

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1 The general types of services provided as mobile medical services are 

2  Mobile medical services (byproduct material, trained personnel, and facility) that provide 

3 the device/facility (e.g., in-van use) and treatment of (or administration to) patients at the 

4 client site. These mobile medical service providers are responsible for all aspects of 

5 byproduct material use and authorized patient treatments (or administrations). 

6  Mobile medical service providers (byproduct material and trained personnel) that provide 

7 transportation to and use of the byproduct material within the client’s facility. These 

8 mobile medical service providers are also responsible for all aspects of byproduct 

9 material use and authorized patient treatments (or administrations). 

10 Mobile medical service licensees must ensure that the criteria in 10 CFR 35.75 are met before 

11 releasing patients treated in their facilities. 

12 Refer to Appendix V of this NUREG for additional guidance on information to provide in 

13 applications and Appendix Z of this NUREG for information on transportation requirements 

14 (10 CFR Part 71 and 49 CFR Parts 171-178). 

15 Agreement State licensees that request reciprocity for activities conducted in NRC States are 

16 subject to the general license provisions described in 10 CFR 150.20. This general license 

17 authorizes persons holding a specific license from an Agreement State to conduct the same 

18 activity in NRC States if the specific license issued by the Agreement State does not limit the 

19 authorized activity to specific locations or installations. Licensees should contact the 

20 appropriate NRC Regional Office for reciprocity information. 

21 An NRC licensee who wishes to conduct operations at temporary jobsites in an Agreement 

22 State should contact that State’s Radiation Control Program Office for information about State 

23 regulations, including notification requirements, whether the AU meets the requirements to be 

24 an AU in that State, and if mobile medical services are allowed within the Agreement State 

25 through reciprocity. The licensee should contact the appropriate Agreement State using the 

26 NRC’s Agreement State Directory. To ensure compliance with Agreement State reciprocity 

27 requirements, an NRC licensee shall request authorization well in advance of scheduled work. 

28 In addition to the requirements specified in 10 CFR 150.20, “Reciprocity,” applicants requesting 

29 a mobile medical service license should contact all States where they plan to conduct mobile 

30 medical services, to clarify requirements, including training and experience requirements for 

31 AUs, as well as requirements associated with an authorization to practice medicine within the 

32 State’s jurisdiction. 

33 Response from Applicant: The applicant should review the guidance in Appendix V of this 

34 NUREG to determine the response required. 
8-75 

1 8.10.18 Release of Patients or Human Research Subjects 

2 Regulations: 10 CFR 35.75

3 Criteria: Licensees may release from confinement patients or 

4 human research subjects (patients) who have been administered 

5 licensed material if the TEDE to any other individual from exposure 

6 to the released patient is not likely to exceed 5 mSv [0.5 rem]. 

7 Licensees must provide radiation safety instructions to patients 

8 released (or to their parent or guardian) in accordance with 

9 10 CFR 35.75(b).

10 Discussion: Under 10 CFR 35.75, the licensee is required to provide the released individual 

11 (patient) with instructions, including written instructions, on actions recommended to maintain 

12 doses to other individuals ALARA if the TEDE to any other individual is likely to exceed 1 mSv 

13 [0.1 rem]. If the dose to a breastfeeding infant or a child could exceed 1 mSv [0.1 rem], 

14 assuming there was no interruption of breastfeeding, the instructions also shall include: 

15  guidance on the interruption or discontinuation of breastfeeding 

16  information on the potential consequences of failure to follow the guidance 

17 Appendix U of this NUREG provides guidance to the applicant for determining when 

18  The licensee may authorize the release of a patient who has been administered 

19 radiopharmaceuticals or who has been treated with implants containing radioactive 

20 material (See Section U.1 in Appendix U of this NUREG). 

21  Instructions to the patient are required by 10 CFR 35.75(b). (See Appendix U.2 of 

22 this NUREG) 

23 Appendix U of this NUREG lists activities for commonly used radionuclides and the 

24 corresponding dose rates with which a patient may be released in compliance with the dose 

25 limits in 10 CFR 35.75. 

26 The NRC has issued additional information on controlling exposures to members of the public. 

27 Licensees should review RIS 2011-01, “NRC Policy on Release of Iodine-131 Therapy Patients 

28 Under 10 CFR 35.75 to Locations Other Than Private Residences,” January 25, 2011, for 

29 NRC’s policy on the release of I-131 therapy patients to locations other than private residences. 

30 Licensees should also review RIS 2008-11, “Precautions to Protect Children Who May Come In 

31 Contact with Patients Released After Therapeutic Administration of Iodine-131,” May 12, 2008, 

32 for precautions that should be taken to protect infants and young children who may come in 

33 contact with patients released after administration of therapeutic amounts of I-131. 

34 Response from Applicant: No response required. 

35 

36 

37 

Part 35 Applicability

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1 8.10.19 Minimization of Contamination 

2 Regulations: 10 CFR 20.1406 and 10 CFR 35.67

3 Criteria: Applicants must describe in the application how facility 

4 design and procedures for operation will minimize, to the extent 

5 practicable, contamination of the facility and the environment, 

6 facilitate eventual decommissioning, and minimize, to the extent 

7 practicable, the generation of radioactive waste in accordance with 

8 10 CFR 20.1406. 

9 Discussion: Applicants should consider the importance of 

10 designing and operating their facilities to minimize the amount of radioactive contamination 

11 generated at the site during its operating lifetime and to minimize the generation of radioactive 

12 waste during decontamination. This is especially important for licensed activities involving 

13 unsealed byproduct material. As described in Section 8.10.5, “Spill/Contamination Procedures,” 

14 cleanup procedures should be implemented for contamination events. Recommended limits for 

15 acceptable levels of surface contamination in restricted and unrestricted areas are provided in 

16 Appendix R, Tables R–2 and R–3 of this NUREG. 

17 Sealed sources and devices that are approved by the NRC or an Agreement State and located 

18 and used according to their SSD registration certificates usually pose little risk of contamination. 

19 Leak tests performed as specified in the SSD registration certificate should identify defective 

20 sources. Leaking sources must be immediately withdrawn from use and stored, repaired, or 

21 disposed of according to NRC requirements in 10 CFR 35.67. These steps minimize the spread 

22 of contamination and reduce radioactive waste associated with decontamination efforts. 

23 Response from Applicant: A response from applicants is not required under the following 

24 condition: The NRC will consider that the above criteria have been met if the information 

25 provided in the applicant’s responses satisfy the criteria in Sections 8.9, 8.9.1, 8.10, 8.10.7, 

26 8.10.15, and 8.11, on the following topics: facility and equipment, facility diagram, radiation 

27 protection program, and waste management. 

28 8.10.20 Records of Dosages and Use of Brachytherapy Sources 

29 Regulations: 10 CFR 30.51, 10 CFR 35.63, 10 CFR 35.204, 

30 

31 10 CFR 35.2063, 10 CFR 35.2204, 10 CFR 35.2406

32 Criteria: Licensees must record the use of licensed material to reflect proper use and 

33 accountability. Records of use must be maintained for 3 years, in 

34 accordance with 10 CFR 30.51. 

35 Discussion: Licensees are required to make and maintain records 

36 of each dosage and administration prior to medical use. In 

37 accordance with 10 CFR 35.2063, the records must include: 

38  radiopharmaceutical 

39  patient’s or human research subject’s name or identification 

40 number (if one has been assigned) 

Part 35 Applicability

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Part 35 Applicability

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1  prescribed dosage, determined dosage, or a notation that the total activity is less than 

2 1.1 MBq [30 μCi] 

3  date and time of dosage determination 

4  name of the individual who determined the dosage 

5 In accordance with 10 CFR 35.63, dosage determination for unit dosages may be made either 

6 by direct measurement or by a decay correction based on the determination (e.g., 

7 measurement) made by the manufacturer or preparer licensed under 10 CFR 32.72 or 

8 equivalent Agreement State requirements or an NRC or Agreement State medical use licensee 

9 authorized under 10 CFR 30.32(j) to produce PET radioactive drugs. If molybdenum-99 

10 (Mo-99) concentration is measured under 10 CFR 35.204, records of Mo-99 concentration must 

11 be made under 10 CFR 35.2204 and must include, for each measured elution of Tc-99m: 

12  ratio of the measurements expressed as kilobecquerel (kBq) (μCi) of Mo-99 per MBq 

13 (mCi) of Tc-99m 

14  date and time of the measurement 

15  name of the individual who made the measurement 

16 If Sr-82 and strontium-85 (Sr-85) concentrations are measured under 10 CFR 35.204, 

17 “Permissible molybdenum-99, strontium-82, and strontium-85 concentrations,” records of Sr-82 

18 and Sr-85 concentrations must be made under 10 CFR 35.2204, “Records of molydenum-99, 

19 strontium-82, and strontium-85 concentrations,” and must include for each measured elution of 

20 Rb-82: 

21  ratio of the measurements expressed in kBq (μCi) of Sr-82 per MBq (mCi) of Rb-82 

22 chloride and kBq (μCi) of Sr-85 per MBq (mCi) of Rb-82 

23  date and time of the measurement 

24  name of the individual who made the measurement 

25 Licensees who use Rb-82/Sr-82 generators should also refer to the CardioGen-82 Highlights of 

26 Prescribing Information for further guidance on documentation and recordkeeping. 

27 If the licensee uses manual brachytherapy sources, the following records of use must be kept in 

28 accordance with 10 CFR 35.2406: 

29  When temporary implant brachytherapy sources are removed from storage, a record will 

30 include the number and activity of sources removed, the time and date they were 

31 removed from storage, the location of use, and the name of the individual who removed 

32 them from storage. 

33  When temporary implant brachytherapy sources are returned to storage, a record will 

34 include the number and activity of sources returned, the time and date they were 

35 returned to storage, and the name of the individual who returned them to storage. 
8-78 

1  For permanent implants, a record will be made and will include the number and activity 

2 of sources removed from storage, the date they were removed from storage, the name 

3 of the individual who removed them from storage, the number and activity of sources not 

4 implanted, the date they were returned to storage, the name of the individual who 

5 returned them to storage, and the number and activity of sources permanently implanted 

6 in the patient or human research subject. 

7 Response from Applicant: No response is necessary. 

8 8.10.21 Recordkeeping 

9 Regulations: 10 CFR Part 20, Subpart L; 10 CFR 30.51; 

10 10 CFR Part 35, Subpart L; 10 CFR 37.23, 37.31, 37.43, 37.75, 

11 and 37.103. 

12 Criteria: Licensees must maintain records as provided in 

13 10 CFR Part 20, Subpart L; 10 CFR 30.51; and 10 CFR Part 35, 

14 Subpart L. In accordance with 10 CFR Part 37, licensees 

15 authorized to possess Category 1 or Category 2 quantities of 

16 radioactive material must maintain records as provided in 10 CFR 

17 37.23, 37.31, 37.43, 37.75, and 37.103. 

18 Discussion: The licensee must maintain certain records to comply with NRC regulations, the 

19 conditions of the license, and commitments made in the license application and correspondence 

20 with the NRC. Operating procedures should identify which individuals in the organization are 

21 responsible for maintaining which records. A table of recordkeeping requirements appears in 

22 Appendix X of this NUREG. 

23 Response from Applicant: No response is necessary. 

24 8.10.22 Reporting 

25 Regulations: 10 CFR Part 20, Subpart M; 10 CFR 21.21; 

26 

27 10 CFR 30.50; 10 CFR 31.5; 10 CFR Part 35, Subpart M

28 Criteria: Licensees are required to report to the NRC via telephone, 

29 written report, or both, in the event that the safety or security of 

30 byproduct material may be compromised. The specific events that 

31 require reporting are explained in 10 CFR Part 35, Subpart M; 10 

32 CFR Part 20, Subpart M; and in 10 CFR 21.21, 30.50, and 31.5. The 

33 timing and type of report are specified within these parts. 

34 Discussion: The NRC requires licensees to report incidents that 

35 might compromise the health and safety of patients, health care 

36 providers, or the public. Therefore, 10 CFR Parts 20, 21, 30, 31, and 

37 35 include provisions that describe reporting requirements associated with the medical use of 

38 byproduct material. A table of reporting requirements appears in Appendix Y of this NUREG. 

39 Response from Applicant: No response is necessary.

Part 35 Applicability

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Part 35 Applicability

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8-79 

1 8.10.23 Transportation 

2 Regulations: 10 CFR 30.41; 10 CFR 37, Subpart D; 10 CFR 71.5; 

3 10 CFR 71.13; 10 CFR 71.17; 10 CFR 71.37; 10 CFR 71, Subpart H; 

4 49 CFR Parts 171-178

5 Criteria: Applicants who will prepare for shipment, ship, or transport 

6 radioactive materials, including radioactive waste, must develop, 

7 implement, and maintain safety programs for the transport of 

8 radioactive material to ensure compliance with NRC and DOT 

9 regulations. 

10 In accordance with 10 CFR Part 37 (Subpart D), licensees must also preplan, coordinate and 

11 provide advance notification of the shipment of Category 1 quantities of radioactive material and 

12 coordinate the shipment of Category 2 quantities of radioactive material. 

13 Discussion: Most packages of licensed material for medical use contain quantities of 

14 radioactive material that require the use of Type A packages. Many packages shipped by 

15 medical licensees (e.g., unused radiopharmaceutical dosages) frequently meet the “Limited 

16 Quantity” criteria described in 49 CFR 173.421, “Excepted Packages for Limited Quantities of 

17 Class 7 (Radioactive) Materials,” and are therefore excepted from certain DOT requirements, 

18 provided certain other less restrictive requirements are met {e.g., activity in the package is less 

19 than the limited quantity and the radiation level on the surface of the package does not exceed 

20 0.005 mSv/h [0.5 mrem/h]}. 

21 The general license in 10 CFR 71.17, “General license: NRC-approved package,” provides the 

22 authorization used by most licensees to transport, or to deliver to a carrier for transport, licensed 

23 material in a package for which a license, certificate of compliance, or other approval has been 

24 issued by the NRC. This general license is subject to certain conditions. The requirements for 

25 transportation of licensed material are set forth in 10 CFR 71.5, “Transportation of Licensed 

26 Material.” The regulations in 10 CFR 71.13 exempt from the requirements in 10 CFR 71.5 any 

27 physician licensed by a State to dispense drugs in the practice of medicine, who is also licensed 

28 under 10 CFR Part 35 or the equivalent Agreement State regulations. This exemption applies 

29 to transport by the physician of licensed material for use in the practice of medicine. 

30 Some medical use licensees (e.g., teletherapy or GSR) may need to ship licensed material in 

31 Type B packages. The Type B package requirements for transporting or delivering the package 

32 to a carrier for transport are set forth in 10 CFR Part 71. These include registration as a user of 

33 the package and the requirement to have an NRC-approved quality assurance (QA) plan. See 

34 10 CFR 71.17(c)(3) for registration information and 10 CFR 71.101 for QA plan information. For 

35 information about these QA programs, see RG 7.10, “Establishing Quality Assurance Programs 

36 for Packaging Used in the Transport of Radioactive Material,” March 2005. For further 

37 information about registering as a user of a package or submitting a QA program for review, 

38 contact NRC’s Division of Spent Fuel Management by calling NRC toll-free at 800-368-5642, 

39 extension 415-9956. For information about associated fees, visit the NRC License Fees Web 

40 site. 

41 Some medical use licensees that ship radioactive material have chosen to transfer possession 

42 of radioactive materials to a manufacturer (or service licensee) with an NRC or Agreement State 

43 license, who then acts as the shipper. The manufacturer (or service licensee) then becomes 

44 responsible for proper packaging of the radioactive materials and compliance with NRC and 

Part 35 Applicability

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8-80 

1 DOT regulations. Licensees who do this must ensure that the manufacturer (or service 

2 licensee): 

3  is authorized to possess the licensed material (see 10 CFR 30.41) 

4  actually takes possession of the licensed material under its license 

5 Licensees should also ensure that the manufacturer (or service licensee) is authorized to 

6 possess the material at temporary jobsites (e.g., the licensee’s facilities). 

7 During an inspection, the NRC uses the provisions of 10 CFR 71.5 and a Memorandum of 

8 Understanding with DOT on the Transportation of Radioactive Material (signed June 6, 1979) to 

9 examine and enforce various DOT requirements applicable to medical use licensees. 

10 Appendix Z of this NUREG lists major DOT regulations that apply to medical use licensees. 

11 Medical use licensees are reminded of the following: 

12  The licensee must properly block and brace the transportation case when transporting 

13 byproduct material to ensure that the material does not shift during transport. 

14  The licensee must have emergency response information, including current emergency 

15 response telephone numbers that meet the requirements of Subpart G, “Emergency 

16 Response Information,” of 49 CFR Part 172, “Hazardous Materials Table, Special 

17 Provisions, Hazardous Materials Communications, Emergency Response Information, 

18 Training Requirements, and Security Plans.” 

19  Initial and recurrent training must be given to all employees who transport byproduct 

20 material per the requirements of Subpart H, “Training,” of 49 CFR Part 172. 

21  The licensee shall maintain transportation shipping records in accordance with the 

22 requirements of Subpart C, “Shipping Papers,” of 49 CFR Part 172, including the proper 

23 shipping name, hazard class (Class 7), United Nations identification number, the name 

24 of the shipper, and the name and activity of each radionuclide. 

Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive material 

are subject to the 10 CFR Part 37, Subpart D (“Physical Protection in Transit”). For additional 

guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, “Implementation 

Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities of 

Radioactive Material.”” Additional information regarding best practices for protection of risksignificant 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. 

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

26 However, before making shipments of licensed materials on its own in a Type B package, a 

27 licensee must have registered with the NRC as a user of the package and obtained the NRC’s 

28 approval of its QA program. Transportation issues will be reviewed during inspection. 
8-81 

1 8.10.24 Security Program for Category 1 and Category 2 Radioactive Material 

2 Regulations: 10 CFR Part 37

3 Criteria: Licensees must ensure the security of Category 1 and 

4 Category 2 radioactive material. 

5 Note: The regulations in 10 CFR Part 37 apply to licensees that 

6 possess an aggregated Category 1 or Category 2 quantity of 

7 radioactive material. The specific radionuclides subject to 10 CFR 

8 Part 37 requirements are listed in Table 1 of Appendix A to 

9 10 CFR Part 37. 

10 Discussion: 

11 Requirements in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities 

12 of Radioactive Material” 

13 In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or 

14 Category 2 quantities of radioactive material must establish, implement, and maintain an access 

15 authorization program (Subpart B) and a security program (Subpart C) to ensure physical 

16 protection of the radioactive material. 

17 Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37 

18 lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

19 should refer to this table to determine whether its proposed activities would be subject to the 

20 10 CFR Part 37 requirements. 

21 Before giving individuals unescorted access to Category 1 or Category 2 quantities of 

22 radioactive material (as defined in 10 CFR 37.5), licensees must conduct background 

23 investigations of these individuals, to determine that they are trustworthy and reliable, in 

24 accordance with 10 CFR 37.25. 

25 In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to 

26 monitor and, without delay, detect, assess, and respond to any actual or attempted 

27 unauthorized access to Category 1 or Category 2 quantities of radioactive material. 

28 Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

29 Category 2 quantities of radioactive materials in transit. These requirements apply to licensees 

30 delivering such material to a carrier for transport, as well as cases in which licensees are 

31 transporting such material. Please note that the Subpart D requirements applicable to the 

32 transport of Category 1 quantities of radioactive material are more stringent than those 

33 applicable to Category 2 quantities. 

Part 35 Applicability

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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. 

1 For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

2 “Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

3 Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

4 for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

5 Security Best Practices for the Protection of Risk-Significant Radioactive Material.” 

6 Response from Applicant: No response is required from an applicant or licensee. 

7 Compliance with access authorization and security program requirements may be reviewed 

8 during NRC inspections. 

9 Note: In accordance with 10 CFR 37.41(a)(3), any licensee that has not previously 

10 implemented the Security Orders (i.e., orders issued by the NRC to require licensees to 

11 implement interim security measures) or been subject to the provisions of 10 CFR Part 37, 

12 Subpart C, shall notify the NRC in writing at least 90 days before aggregating radioactive 

13 material to a quantity that equals or exceeds the Category 2 threshold. 

14 8.11 Item 11: Waste Management 

15 Regulations: 10 CFR 20.1101, 10 CFR 20.1301, 

16 10 CFR 20.1302, 10 CFR 20.1501, 10 CFR 20.1902, 

17 10 CFR 20.1904, 10 CFR 20.2001-2008, 10 CFR 30.3, 

18 10 CFR 30.41(b), 10 CFR 31.11; 10 CFR 35.92, 10 CFR 

19 37.11(c), 10 CFR 61.3

20 Criteria: Licensed materials must be disposed of in 

21 accordance with NRC requirements by: 

22  transfer to an authorized recipient (10 CFR 30.41(b), 20.2006, 20.2008) 

23  decay-in-storage (10 CFR 35.92) 

24  release in effluents within the limits in 10 CFR 20.1301 or 

25  as authorized under 10 CFR 20.2002 through 20.2005

26 Discussion: The radiation protection program that licensees are required to develop, 

27 document, and implement in accordance with 10 CFR 20.1101 must include provisions for 

28 waste disposal of licensed material. Appendix W of this NUREG contains model procedures 

29 that represent one way to provide for decay-in-storage and generator or other licensed material 

30 

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8-83 

1 return. Applicants are reminded to take into account the following information when they 

2 develop procedures (as applicable): 

3  The NRC has concluded that materials with half-lives of less than or equal to 120 days 

4 are appropriate for decay-in-storage (DIS) and interim storage. The holding time of the 

5 waste should be based on the radionuclide(s), half life, and the activity present when the 

6 waste was placed into storage. Such waste may be disposed of as in-house trash if 

7 radiation surveys of the waste indicate that radiation levels are indistinguishable from 

8 background. The surveys should be performed with an appropriate radiation detection 

9 meter set on its most sensitive scale in a low background area and without any 

10 interposed shielding. In accordance with 10 CFR 20.1904(b), all radiation labels must 

11 be defaced or removed from containers and packages prior to disposal as ordinary 

12 trash, except for radiation labels on materials that are within containers and that will be 

13 managed as biomedical waste after they have been released. If the decayed waste is 

14 compacted, all labels that are visible in the compacted mass must also be defaced or 

15 removed. Applicants must maintain accurate records of such disposals. 

16  Except for material suitable for decay-in-storage and some animal carcasses handled by 

17 the licensee, solids are transferred to an authorized recipient licensed to receive such 

18 waste in accordance with 10 CFR 20.2001(b), 10 CFR 20.2006, or in applicable 

19 regulations in 10 CFR 30.3 or 10 CFR 61.3. Follow the packaging instructions received 

20 from the transfer agent and the burial site operator. Keep the consignment sheet from 

21 the transfer agent as the record of disposal. 

22  When setting up a program for decay-in-storage, consider short-term and long-term 

23 storage. Consider designing long-term storage to allow for segregation of wastes with 

24 different half-lives (e.g., the use of multiple shielded containers) and use of containers 

25 with shielded covers to maintain occupational exposure at ALARA levels. Storage areas 

26 must be in a secure location and appropriately posted in accordance with 

27 10 CFR 20.1902. In addition, all storage containers must be appropriately labeled in 

28 accordance with 10 CFR 20.1904. Note: Some short half-life radionuclide products 

29 (e.g., samarium-153, Tc-99m/Mo-99 generator columns and Y-90 microspheres) may 

30 contain long half-life contaminants that may preclude disposal by decay-in-storage. 

31 Long-lived contaminants need not be listed on an NRC license; however, licensees need 

32 to perform surveys and dispose of the material in accordance with 10 CFR Parts 20 and 

33 35 requirements. Licensees using Y-90 microspheres should review IN 2007-10, 

“Yttrium-90 Theraspheres® and Sirspheres® 34 Impurities,” for applicability. 

35  Check and calibration sources with half-lives greater than 120 days (e.g., cobalt-57, 

36 germanium-68, gadolinium-153) may not be held for decay-in-storage and must be 

37 disposed of in accordance with 10 CFR Part 20. 

38  Waste from in vitro kits (except mock I-125) that are generally licensed under 

39 10 CFR 31.11 is exempt from waste disposal regulations in 10 CFR Part 20, as set forth 

40 in 10 CFR 31.11(f). Radioactive labels should be defaced or removed. There is no 

41 need to keep any record of release or make any measurement. 

42  In accordance with 10 CFR 20.1302, consider the monitoring and control mechanisms in 

43 place to ensure compliance with the appropriate requirements regarding the release of 
8-84 

1 material into air and water under 10 CFR 20.1301, “Dose Limits for Individual Members 

2 of the Public,” and 20.2003, “Disposal by Release into Sanitary Sewerage,” respectively. 

3 — Regulations for disposal in the sanitary sewer appear in 10 CFR 20.2003. 

4 Material must be readily soluble or dispersible in water. There are also monthly 

5 and annual limits, based on the total sanitary sewerage release of the facility. 

6 (Excreta from patients undergoing medical diagnosis or therapy are not subject 

7 to these limitations. See 10 CFR 20.2003(b).) 

8 — Limits on permissible concentrations in effluents to unrestricted areas are 

9 enumerated in Table II of Appendix B to 10 CFR Part 20. These limits apply at 

10 the boundary of the restricted area. 

11 — Liquid scintillation-counting media containing 1.85 kBq [0.05 μCi] per gram of H-3 

12 or C-14 may be disposed of without regard to their radioactivity 

13 [10 CFR 20.2005(a)(1)]. 

14  If applicants/licensees propose to treat or dispose of licensed material by incineration, 

15 they must comply with 10 CFR 20.2004. Contact the appropriate NRC Regional Office 

16 for guidance on treatment or disposal of material by incineration. 

17  Applicants that wish to use waste volume reduction operations (e.g., compactors) should 

18 provide a detailed description (as outlined below), along with their response to 

19 Section 8.9.1, Facility Diagram: 

20 — a description of the compactor to demonstrate that it is designed to safely 

21 compact the waste generated (e.g., manufacturer’s specifications, annotated 

22 sketches, photographs) 

23 — the types, quantities, and concentrations of the waste to be compacted 

24 — an analysis of the potential for airborne release of radioactive material during 

25 compaction activities 

26 — the location of the compactors in the waste processing area(s), as well as a 

27 description of the ventilation and filtering systems used in conjunction with the 

28 compactors, and procedures for monitoring filter blockage and exchange 

29 — methods used to monitor worker breathing zones and/or exhaust systems 

30 — the types and frequencies of surveys that will be performed for contamination 

31 control in the compactor area 

32 — the instructions provided to compactor operators, including instructions for 

33 protective clothing, checks for proper functioning of equipment, and methods of 

34 handling uncompacted waste and examining containers for defects 

35 

36 
8-85 

1 Note: Before licensed activities are transferred or assigned in accordance with 

2 10 CFR 30.34(b), if licensees are authorized to possess byproduct material with a half-life 

3 greater than 120 days in an unsealed form, the licensees must, in accordance with 

4 10 CFR 30.51(e), transfer the following records to the new licensee:

5  records of disposal of licensed material made under: 

6 

7 — 10 CFR 20.2002, “Method for obtaining approval of proposed disposal 

8 procedures“ 

9 — 10 CFR 20.2003, “Disposal by release into sanitary sewerage” 

10 — 10 CFR 20.2004, “Treatment or disposal by incineration 

11 — 10 CFR 20.2005, “Disposal of specific wastes” 

12  records required by 20.2103(b)(4) of the results of measurements and calculations used 

13 to evaluate the release of radioactive effluents to the environment 

14 Nuclear pacemakers: Medical licensees are often the first to come into contact with 

15 plutonium-powered pacemakers or the first to be contacted by nursing homes and funeral 

16 homes when a patient with an implanted pacemaker dies. In such cases, and when the 

17 licensee is not responsible for control or disposal of the pacemaker, notify the NRC and attempt 

18 to contact the hospital where the pacemaker was implanted to arrange for explanation. The 

19 licensee that implanted the device is responsible for the follow-up, explanation, and return of the 

20 pacemaker to the manufacturer for proper disposal. IN 98-12, “Licensees’ Responsibilities 

21 Regarding Reporting and Follow-up Requirements for Nuclear-Powered Pacemakers,” 

22 April 3, 1998, provides additional information. 

23 Waste Return from Landfills or Medical Incinerators: Medical licensees are periodically 

24 contacted by the waste broker after receipt of potentially contaminated medical waste. As 

25 described in IN 99-33, “Management of Wastes Contaminated with Radioactive Materials,” 

26 December 21, 1999, licensees must evaluate waste in accordance with 10 CFR 20.1501, 

27 “Surveys and Monitoring,” and manage the storage and or disposal of the waste in accordance 

28 with applicable regulations and license conditions. 
8-86 

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 

2 Response from Applicant: For other treatment or disposal of waste, provide the following 

3 statement: 

4 “We have developed and will implement and maintain written waste disposal procedures for 

5 licensed material, in accordance with 10 CFR 20.1101, that also meet the requirements of the 

6 applicable section of Subpart K to 10 CFR Part 20, Subpart K, and of 10 CFR 35.92.” 

7 Contact the appropriate NRC Regional Office for guidance on treatment or disposal of waste by 

8 incineration. 

9 References and Resources: 

10 • Information Notice 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste 

11 Generators on the Elements of a Waste Minimization Program,” dated March 1994 

12 • Information Notice 94-07, “Solubility Criteria for Liquid Effluent Releases to Sanitary 

13 Sewerage Under the Revised 10 CFR Part 20,” dated January 1994 
8-87 

1 • Information Notice 84-94, “Reconcentration of Radionuclides Involving Discharges into 

2 Sanitary Sewage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003),” 

3 dated December 1984 

4 • Information Notice 90-09, “Extended Interim Storage of Low Level Radioactive Waste by 

5 Fuel Cycle and Materials Licensees,” dated February 1990 

6 • Regulatory Issue Summary 2008-12, “Considerations For Extended Interim Storage Of 

7 Low Level Radioactive Waste By Fuel Cycle And Materials Licensees” 

8 • Regulatory Issue Summary 2011-09, “Available Resources Associated With Extended 

9 Storage Of Low Level Radioactive Waste” 

10 • Policy and Guidance Directive PG 8-10, “Disposal of Incineration Ash as Ordinary 

11 Waste,” January 1997, ADAMS Accession Nos. ML003744979 and ML003752866 and 

12 Addendum, ADAMS Accession Nos. ML003744984 and ML003744988. 

13 • NRC Regulatory Issue Summary 2004 17, Revision 1, Revised Decay-In-Storage 

14 Provisions For The Storage Of Radioactive Waste Containing Byproduct Material, 

15 September 2005 

16 • State and Tribal Communication Letter FSME 12-025 dated March 13, 2012 

17 “Clarification of the Authorization for Alternative Disposal of Material Issued Under 10 

18 CFR 20.2002 and Exemption Provisions in 10 CFR” (ADAMS Accession No. 

19 ML12065A038) 

20 8.12 Item 12: License Fees 

21 Regulation: 10 CFR 170.31

22 On NRC Form 313, enter the appropriate fee category from 

23 10 CFR 170.31 and the amount of the fee enclosed with the 

24 application. 

25 Direct all questions about the NRC’s fees or completion of Item 12 of 

26 NRC Form 313 to the Office of the Chief Financial Officer at NRC 

27 Headquarters in Rockville, MD, 301-415-7554. Information about 

28 fees may also be obtained by calling NRC’s toll free number, 800-

29 368-5642, extension 415-7554. The e-mail address for fees 

30 questions is Fees.Resource@nrc.gov. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
8-88 

1 8.13 Item 13: Certification 

2 A representative of the corporation or legal entity filing the 

3 application must sign and date NRC Form 313. The representative 

4 signing the application must be authorized to make binding 

5 commitments and to sign official documents on behalf of the 

6 applicant. As discussed previously in Chapter 3, “Management 

7 Responsibility,” signing the application acknowledges management’s 

8 commitment to and responsibility for the radiation protection 

9 program. The NRC will return all unsigned applications for proper 

10 signature. 

11 Notes: 

12  It is a criminal offense to knowingly and willfully make a false statement or 

13 representation on applications or correspondence (18 U.S.C. 1001). 

14  When an application references commitments, those items will be incorporated into the 

15 license and, therefore, will become binding regulatory requirements.

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
9-1 

1 9 LICENSE AMENDMENTS AND RENEWALS 

2 9.1 Timely Submittals of Amendments and Renewals 

3 Regulations: 10 CFR 2.109(a), 10 CFR 30.36, 10 CFR 30.37, 

4 10 CFR 30.38, 10 CFR 35.12, 

5 10 CFR 35.13, 10 CFR 35.14, 10 CFR 35.24(c)

6 Criteria: It is the licensee’s obligation to keep the license 

7 current. If any of the information provided in the original 

8 application is to be modified or changed, the licensee must 

9 submit an application for a license amendment before the change 

10 takes place. The change is not in effect until the amendment has 

11 been issued. Also, to continue the license after its expiration date, the licensee must submit an 

12 application for a license renewal at least 30 days before the expiration date [10 CFR 2.109(a), 

13 10 CFR 30.36(a)]. 

14 Discussion: Under Title 10 of the Code of Federal Regulations (CFR)10 CFR 35.13, “License 

15 amendments,” a licensee is required to apply for and receive a license amendment before 

16 several activities can occur, including: 

17  receiving or using byproduct material for a type of use permitted by 10 CFR Part 35, but 

18 not authorized on the licensee’s current Part 35 license 

19  permitting anyone to work as an authorized user (AU) for medical uses, authorized 

20 medical physicist (AMP), or authorized nuclear pharmacist (ANP), unless the individual 

21 meets one of the exceptions listed in 10 CFR 35.13(b) [information required to document 

22 training and experience may be provided on the appropriate U.S. Nuclear Regulatory 

23 Commission (NRC) Form 313A series of forms for change or addition of AU for medical 

24 uses, AMP, ANP, or radiation safety officer (RSO)] 

25  changing the RSO 

26  receiving byproduct material in excess of the amount, or receiving radionuclides or forms 

27 different than currently authorized on the NRC license 

28  changing an area or address of use identified in the application or on the license; 

29 includes additions and relocations 

30  revising procedures required by 10 CFR 35.610, 35.642, 35.643, and 35.645, when the 

31 revision reduces the level of radiation safety 

32 In case of a medical emergency requiring an expedited license amendment, contact the 

33 materials licensing staff at the appropriate NRC regional office. 

34 Response from Applicant: No response is required from an applicant for a new license. 

35 Applicants for license amendment or renewal should do the following: 

36  Use the most recent guidance in preparing an amendment or renewal request. 

Part 35 Applicability 

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
9-2 

1  Submit either an NRC Form 313 or a letter requesting an amendment or renewal. 

2 (10 CFR 30.37, 10 CFR 30.38, 10 CFR 35.12)

3  Provide the license number and docket number. 

4 For renewals, provide a complete and up-to-date application, including all required program 

5 elements outlined in Appendix C of this NUREG. The licensee may reference recent 

6 documents that have been previously accepted. Training documentation for personnel currently 

7 listed on the license does not need to be submitted as part of the renewal application. 

8 9.2 Timely Notification of Transfer of Control 

9 9.2.1 Transfer of Control 

10 Regulation: 10 CFR 30.34(b)

11 Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

12 consent before transferring control of the license, also referred to as a “change of ownership” 

13 and/or “transferring the license.” 

14 Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

15 transfers. Although it is not the NRC’s intent to interfere with the business decisions of 

16 licensees, under 10 CFR 30.34(b) and the Atomic Energy Act, licensees must obtain prior NRC 

17 written consent before transferring control of the license to ensure the following: 

18  Radioactive materials are possessed, used, or controlled only by persons who have 

19 valid NRC licenses or Agreement State licenses. 

20  Materials are properly handled and secured. 

21  Persons using these materials are capable, competent, and committed to implementing 

22 appropriate radiological controls. 

23  A clear chain of custody is established to identify who is responsible for disposition of 

24 records and licensed material. 

25  Adequate financial assurance is provided for compliance with the applicable NRC 

26 requirements, if required. 

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

28 Response from Applicant: No response is required from an applicant for a new license. 

29 However, current licensees should refer to NUREG–1556, Volume 15, “Consolidated Guidance 

30 About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special 

31 Nuclear Materials Licenses,” for more information about transfer of control (i.e., ownership). 

32 Reference: For further information, see Regulatory Issue Summary (RIS) 2014-08, Rev. 1 

33 “Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials 

34 Licenses,” dated May 5, 2016. 
9-3 

1 9.2.2 Notification of Bankruptcy Proceedings 

2 Regulation: 10 CFR 30.34(h) 

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

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

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

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

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

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

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

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

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

12 bankruptcy actions are completed and may request that the U.S. Department of Justice 

13 represent the NRC’s interests in the bankruptcy proceeding. 

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

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

16 involuntary petition for bankruptcy by or against the licensee. 

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

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

19 Special Nuclear Materials Licenses.” 

20 9.2.3 Other 

21 Licensees are required to notify the NRC of program changes as noted below:

22  decommissioning activities in accordance with 10 CFR 30.36(d)

23  new AUs, AMPs, and ANPs who meet the criteria in 10 CFR 35.14(a)

24  current AUs, AMPs, ANPs, and RSOs permanently discontinuing duties in accordance 

25 with 10 CFR 35.14(b)(1)

26  temporary RSOs in accordance with 10 CFR 35.14(b)(2) and 35.24(c)

27  change in mailing address in accordance with 10 CFR 35.14(b)(3)

28  name change that does not constitute a transfer of control in accordance with 10 CFR 

29 35.14(b)(4)

 new areas of use or changes to the areas of use where 10 CFR 35.100 and 200

materials are used in accordance with 10 CFR 35.14(b)(5)

Note: an amendment is needed to release for unrestricted use

10-1 

1 10 APPLICATIONS FOR EXEMPTIONS 

2 Regulations: 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11, 

3 10 CFR 35.15, 10 CFR 35.19

4 Criteria: Licensees may request exemptions from U.S. Nuclear 

5 Regulatory Commission (NRC) regulations. The licensee must 

6 demonstrate that the exemption is authorized by law; will not 

7 endanger life, property, or the common defense and security; and is 

8 otherwise in the public interest. 

9 Discussion: Various sections of the NRC’s regulations address 

10 requests for exemptions (e.g., Title 10 of the Code of Federal 

11 Regulations (CFR) 10 CFR 19.31, “Applications for exemptions;” 10 CFR 20.2301, “Applications 

12 for exemptions;” 10 CFR 30.11, “Specific Exemptions;” and 10 CFR 35.19, “Specific 

13 Exemptions”). These regulations state that the NRC may grant an exemption, acting on its own 

14 initiative or on an application from an interested person. 

15 Exemptions are not intended to revise regulations or to apply to large classes of licensees and 

16 are generally limited to unique situations. Requests for exemptions submitted to the NRC must 

17 identify the regulation for which the exemption is being requested and include a justification for 

18 the requested exemption. 

19 Type A broad scope licensees are granted certain exemptions as described in 10 CFR 35.15, 

20 “Exemptions regarding Type A specific licenses of broad scope.” 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓

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: 10 CFR 20 Subpart E, 10 CFR 30.34(b), 

3 10 CFR 30.35(g), 10 CFR 30.36, 10 CFR 30.51, 10 CFR 40.42, 

4 10 CFR 40.51, 10 CFR 40.61

5 Criteria: In accordance with Title 10 of the Code of Federal 

6 Regulations (CFR) 10 CFR 30.36(d) and 10 CFR 40.42(d), the 

7 licensee must do the following: 

8  Notify the U.S. Nuclear Regulatory Commission (NRC), in 

9 writing, within 60 days of the occurrence of any of the 

10 following: 

11 — expiration of its license 

— a decision to permanently cease principle activities1 12 at the entire site 

13 — for licensees subject to 10 CFR 30.36, a decision to permanently cease principle 

activities1 14 in any separate building or outdoor area that contains residual 

15 radioactivity such that the building or area is unsuitable for release according to 

16 NRC requirements 

17 — for licensees subject to 10 CFR 40.42, a decision to permanently cease principal 

activities1 18 in any separate building or outdoor area 

— no principal activities1 19 under the license have been conducted for a period of 

20 24 months 

— no principal activities1 21 have been conducted for a period of 24 months in any 

22 separate building or outdoor area that contains residual radioactivity such that 

23 the building or area is unsuitable for release according to NRC requirements 

24  Submit a decommissioning plan, if required by 10 CFR 30.36(g) or 10 CFR 40.42(g). 

25  Conduct decommissioning, as required by 10 CFR 30.36(h) and (j) or 10 CFR 40.42(h) 

26 and (j). 

27  Submit, to the appropriate NRC regional office, a completed NRC Form 314, “Certificate 

28 of Disposition of Materials,” (or equivalent information) and information demonstrating 

29 that the premises are suitable for release for unrestricted use (e.g., results of final 

30 surveys and results of leak tests of sealed sources). 

31  Before a license is terminated, send the records important to decommissioning that are 

32 required by 10 CFR 30.35(g) and/or 10 CFR 40.36(f) to the appropriate NRC regional 

33 office, in accordance with 10 CFR 30.51(d) and (f) or 10 CFR 40.61(d) and (f). 

 

1

‘Principal activities’ are activities that are essential to achieving the purpose(s) for which the license was issued or 

amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to 

decontamination or decommissioning are not principal activities. 

Part 35 Applicability

100 ✓

200 ✓

300 ✓

400 ✓

500 ✓

600 ✓

1000 ✓
11-2 

1  Before a license is terminated, send records of disposal of licensed material made under 

2 10 CFR 20.2002, 20.2003, 20.2004, 20.2005, and the results of measurement and 

3 calculations used to evaluate the release of radioactive effluents to the environment to 

4 the appropriate NRC regional office in accordance with 10 CFR 30.51(d) and/or 

5 10 CFR 40.61(d), if authorized to possess byproduct material with a half-life greater than 

6 120 days in an unsealed form and/or source material in an unsealed form, respectively. 

7 Discussion: To comply with the above criteria, before a licensee can decide whether it must 

8 notify the NRC under 10 CFR 30.36(d), the licensee must determine whether residual 

9 radioactivity is present and, if so, whether the levels make the building or outdoor area 

10 unsuitable for release, according to the NRC requirements. A licensee’s determination that a 

11 facility is not contaminated is subject to verification by NRC inspection. For information about 

12 requirements that apply to the timeliness of decommissioning, see Regulatory Issue Summary 

13 (RIS) 2015-19, Revision 1, “Decommissioning Timeliness Rule Implementation and Associated 

14 Regulatory Relief,” dated September 27, 2016. 

15 In general, most medical licensees use licensed material with short half-lives 

16 [e.g., technetium-99m (Tc-99m) with a 6-hour half-life] and sealed sources (e.g., dose calibrator 

17 sources and manual brachytherapy sources). In addition, most medical licensees do not 

18 dispose of licensed material to the sanitary sewer. Therefore, in these instances, the licensees 

19 should submit the following: 

20  area radiation level surveys, including a description of instruments used, showing that all 

21 areas previously used are at background 

22  area contamination wipes, including a description of instruments used, showing that all 

23 areas previously used are at background 

24  leak tests for all sealed sources transferred or disposed 

25  transfer or disposal documentation for all sealed sources (and unsealed material, if 

26 applicable) 

27 If the half-life of the licensed material used is sufficiently short compared to the time of last use, 

28 area surveys and contamination wipes may be unnecessary. For instance, if only Tc-99m has 

29 ever been used and the last use was a month ago, surveys would not be warranted. 

30 For guidance on the disposition of licensed material, see Section 8.11, “Waste Management.” 

31 For guidance on decommissioning records, see Section 8.5.2, “Financial Assurance and 

32 Recordkeeping for Decommissioning.” 

33 For regulations governing radiological criteria for license termination, licensees should refer to 

34 10 CFR Part 20 Subpart E. 

35 NUREG–1757, Volume 1, “Decommissioning Process for Materials Licensees,” September 

36 2006, contains the current regulatory guidance concerning decommissioning of facilities and 

37 termination of licenses. NUREG–1757, Volume 2, “Consolidated Decommissioning Guidance: 

38 Characterization, Survey, and Determination of Radiological Criteria,” September 2006, may 

39 also be useful guidance in describing the disposition of licensed material and facilities. 
11-3 

1 Response from Applicant: The applicant is not required to submit a response to the NRC 

2 during the initial application. The licensee’s obligations in this matter begin when the license 

3 expires or at the time the licensee ceases operations, whichever is earlier. These obligations 

4 are to undertake the necessary decommissioning activities, to submit NRC Form 314 or 

5 equivalent information, and to perform any other actions summarized in “Criteria” above. 

6 Reference: NRC Form 314 is available at http://www.nrc.gov/reading-rm/doc-collections/forms.

1 APPENDIX A 

2 SAFETY CULTURE POLICY STATEMENT 

A–1 

1 Safety Culture 

2 The safety culture policy statement was published in the Federal Register (76 FR 34773) on 

3 June 14, 2011, and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-

4 14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission (NRC) Agencywide 

5 Documents Access and Management System Accession Number ML11146A047. 

6 Safety Culture Policy Statement 

7 The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

8 individuals and organizations establish and maintain a positive safety culture commensurate 

9 with the safety and security significance of their activities and the nature and complexity of their 

10 organizations and functions. This includes all licensees, certificate holders, permit holders, 

11 authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

12 safety-related components, and applicants for a license, certificate, permit, authorization, or 

13 quality assurance program approval, subject to NRC authority. The Commission encourages 

14 the Agreement States, Agreement State licensees, and other organizations interested in nuclear 

15 safety to support the development and maintenance of a positive safety culture, as articulated in 

16 this Statement of Policy. 

17 Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

18 commitment by leaders and individuals to emphasize safety over competing goals to ensure 

19 protection of people and the environment. Individuals and organizations performing regulated 

20 activities bear the primary responsibility for safety and security. The performance of individuals 

21 and organizations can be monitored and trended and, therefore, may be used to determine 

22 compliance with requirements and commitments and may serve as an indicator of possible 

23 problem areas in an organization’s safety culture. The NRC will not monitor or trend values. 

24 These will be the organization’s responsibility as part of its safety culture program. 

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

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

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

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

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

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

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

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

33 with NRC-regulated activities. 

34 Experience has shown that certain personal and organizational traits are present in a positive 

35 safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that 

36 emphasizes safety, particularly in goal conflict situations, e.g., production, schedule, and the 

37 cost of the effort versus safety. It should be noted that although the term ‘‘security’’ is not 

38 expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

39 regulatory mission. Consequently, consideration of both safety and security issues, 

40 commensurate with their significance, is an underlying principle of this Statement of Policy. 

41 The following are traits of a positive safety culture: 

42 (1) Leadership Safety Values and Actions – Leaders demonstrate a commitment to safety in 

43 their decisions and behaviors; 
A–2 

1 (2) Problem Identification and Resolution – Issues potentially impacting safety are promptly 

2 identified, fully evaluated, and promptly addressed and corrected commensurate with 

3 their significance; 

4 (3) Personal Accountability – All individuals take personal responsibility for safety; 

5 (4) Work Processes – The process of planning and controlling work activities is 

6 implemented so that safety is maintained; 

7 (5) Continuous Learning – Opportunities to learn about ways to ensure safety are sought 

8 out and implemented; 

9 (6) Environment for Raising Concerns – A safety-conscious work environment is maintained 

10 where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

11 harassment, or discrimination; 

12 (7) Effective Safety Communication – Communication maintains a focus on safety; 

13 (8) Respectful Work Environment – Trust and respect permeate the organization; and 

14 (9) Questioning Attitude – Individuals avoid complacency and continuously challenge 

15 existing conditions and activities in order to identify discrepancies that might result in 

16 error or inappropriate action. 

17 There may be traits not included in this Statement of Policy that are also important in a positive 

18 safety culture. It should be noted that these traits were not developed to be used for 

19 inspection purposes. 

20 It is the Commission’s expectation that all individuals and organizations, performing or 

21 overseeing regulated activities involving nuclear materials, should take the necessary steps to 

22 promote a positive safety culture by fostering these traits as they apply to their organizational 

23 environments. The Commission recognizes the diversity of these organizations and 

24 acknowledges that some organizations have already spent significant time and resources in the 

25 development of a positive safety culture. The Commission will take this into consideration as 

26 the regulated community addresses the Statement of Policy. 
1 APPENDIX B 

2 U.S. NUCLEAR REGULATORY COMMISSION FORM 313

B–1 

1 U.S. Nuclear Regulatory Commission Form 313 

Please use the most current version of this form, which may be found at: 

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

1 APPENDIX C 

2 LICENSE APPLICATION CHECKLISTS 

 C–1 

1 License Application Checklists 

2 This Appendix contains links and checklists that may be used to assist in organizing an 

3 application, including the U.S. Nuclear Regulatory Commission (NRC) Form 313, “Application 

4 for Materials License,” and the NRC Form 313A series, “Medical Use Training and Experience 

5 and Preceptor Attestation,” which can be found on the Medical Uses Licensee Toolkit.

6 Items 1-4 and 12-13 may be completed on NRC Form 313. Table C–1 may be used to describe 

7 Item 5 (Radioactive Material) and Item 6 (Purpose of Use), and Table C–2 may be used to 

8 describe Items 7 and 8 (Training and Experience), Item 9 (Facilities and Equipment), Item 10 

9 (Radiation Safety Program), and Item 11 (Waste Management). Table C–3, Applicable 

10 Appendices Describing Model Procedures, may be helpful to applicants in developing 

11 procedures for inclusion in their radiation safety program. Please note that the procedures 

12 provided are not all-inclusive (e.g., full calibration and emergency procedures for therapy 

13 devices are not included and only references to American Association of Physicists in Medicine 

14 and American National Standards Institute standards are made in this NUREG document). In 

15 addition, uses conducted under Title 10 of the Code of Federal Regulations (10 CFR) 35.1000

16 may require procedures specific to the emerging technology; however, the procedures 

17 described in the document may be helpful in developing these procedures. Finally, Appendix X, 

18 Y, and Z of this NUREG are not model procedures; however, they are included in Table C–3 to 

19 remind licensees of recordkeeping, reporting, and transportation requirements. 

20 Table C–1 outlines the detailed responses that may be made to Items 5 and 6 on Form 313 for 

21 the type of radioactive material requested and the purposes for which it will be used. For 

22 example, if the applicant is seeking a license for unsealed byproduct material under 

23 10 CFR 35.100, “Use of unsealed byproduct material for uptake, dilution, and excretion studies 

24 for which a written directive is not required,” or 35.200, “Use of unsealed byproduct material for 

25 imaging and localization studies for which a written directive is not required,” then the applicant 

26 should check the “yes” column next to 10 CFR 35.100 and 35.200 in Table C–1. The table then 

27 indicates appropriate responses for that type of use. An applicant may copy the checklist and 

28 include it in the license application. 

29 The applicant should review the guidance in Chapter 6, “Identifying and Protecting Sensitive 

30 Information,” and mark security-related sensitive information appropriately. 
 C–2 

Table C–1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use 

This response includes security-related sensitive information that is included in 

Attachment _____ and marked “Security-related information – withhold under 

10 CFR 2.390” ❑ Yes ❑ No

Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use 

❒Any byproduct 

material permitted 

by 10 CFR 35.100 

Any As needed Any uptake, dilution, and 

excretion study permitted by 

10 CFR 35.100. 

❒Any byproduct 

material permitted 

by 10 CFR 35.200 

Any As needed Any imaging and localization 

study permitted by 

10 CFR 35.200. 

❒Any byproduct 

material permitted 

by 10 CFR 35.300 

(Note: Check this 

box if using all 

radionuclides 

covered by 

35.300; otherwise, 

check subsequent 

boxes if limiting 

use by 

radionuclide). 

Any _____ 

millicuries 

(mCi) 

Any radiopharmaceutical 

therapy procedure permitted 

by 10 CFR 35.300. 

❒inpatient (facility diagram 

attached) 

❒outpatient 

(Note: Check the inpatient 

box if keeping patients 

in-house who are not 

releasable pursuant to 

10 CFR 35.75. If releasable, 

check outpatient.) 

❒Iodine-131 

permitted by 

10 CFR 35.300 

Any ___mCi Oral administration of sodium 

iodide iodine-131. 

❒inpatient (facility diagram 

attached) 

❒outpatient 

❒Samarium-153 

permitted by 

10 CFR 35.300 

Any ___mCi Parenteral administration of 

samarium-153 

❒inpatient (facility diagram 

attached) 

❒outpatient 

❒Other 

Radionuclide 

permitted by 

10 CFR 35.300 

______________ 

Any ___mCi Purpose of Use 

❒inpatient (facility diagram 

attached) 

❒outpatient 

❒Iodine-125 

permitted by 

10 CFR 35.400 

Sealed sources 

(Manufacturer 

______________, 

Model No._____) 

___mCi Any manual brachytherapy 

procedure permitted by 

10 CFR 35.400. 

❒outpatient 

❒Palladium-103 

permitted by 

10 CFR 35.400 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

___mCi Any manual brachytherapy 

procedure permitted by 

10 CFR 35.400. 

❒outpatient 

 
 C–3 

Table C–1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued) 

This response includes security-related sensitive information that is included in 

Attachment _____ and marked “Security-related information – withhold under 

10 CFR 2.390” ❑ Yes ❑ No

Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use

❒Iridium-192 

permitted by 

10 CFR 35.400 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

___mCi Any manual brachytherapy 

procedure permitted by 

10 CFR 35.400. 

❒inpatient (facility diagram 

attached) 

❒Cesium-131 

permitted by 

10 CFR 35.400 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

___mCi Any manual brachytherapy 

procedure permitted by 

10 CFR 35.400. 

❒outpatient 

❒Cesium-137 

permitted by 

10 CFR 35.400 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

___mCi Any manual brachytherapy 

procedure permitted by 

10 CFR 35.400. 

❒inpatient (facility diagram 

attached) 

❒Strontium-90 

permitted by 

10 CFR 35.400 

Sealed source 

(Manufacturer 

______________, 

Model No._____) 

___mCi Strontium-90 for ophthalmic 

radiotherapy permitted by 

10 CFR 35.400. 

❒Iodine-125 

permitted by 

10 CFR 35.500 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

Device (Manufacturer 

______________, 

Model No. _____) 

___curies per 

source and 

___curies total 

Diagnostic medical use of 

sealed sources permitted by 

10 CFR 35.500 in compatible 

devices registered pursuant to 

10 CFR 30.32(g). 

❒Barium-133 

permitted by 

10 CFR 35.500 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

Device (Manufacturer 

______________, 

Model No. _____) 

___curies per 

source and 

___curies total 

Diagnostic medical use of 

sealed sources permitted by 

10 CFR 35.500 in compatible 

devices registered pursuant to 

10 CFR 30.32(g). 

❒Cesium-137 

permitted by 

10 CFR 35.500 

Sealed sources 

(Manufacturer 

___________, Model 

No. _____) 

Device (Manufacturer 

______________, 

Model No. _____) 

___curies per 

source and 

___curies total 

Diagnostic medical use of 

sealed sources permitted by 

10 CFR 35.500 in compatible 

devices registered pursuant to 

10 CFR 30.32(g). 
 C–4 

Table C–1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued) 

This response includes security-related sensitive information that is included in 

Attachment _____ and marked “Security-related information – withhold under 

10 CFR 2.390” ❑ Yes ❑ No

Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use

❒Gadolinium-153 

permitted by 

10 CFR 35.500 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

Device (Manufacturer 

______________, 

Model No. _____) 

___curies per 

source and 

___curies total 

Diagnostic medical use of 

sealed sources permitted by 

10 CFR 35.500 in compatible 

devices registered pursuant to 

10 CFR 30.32(g). 

❒Iridium-192 

permitted by 

10 CFR 35.600 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

___curies per 

source and 

___curies total 

One source for medical use 

permitted by 10 CFR 35.600, 

in a Manufacturer 

__________________, Model 

No. _________ remote 

afterloader unit. One source 

in its shipping container as 

necessary for replacement of 

the source in the remote 

afterloader device. 

Note: If requesting an individual source activity of greater than 10 curies, see the Medical Uses 

Licensee Toolkit for the current models approved for a higher activity. 

❒Cobalt-60 

permitted by 10 

CFR 35.600 

Sealed sources 

(Manufacturer 

______________, 

Model No._____) 

___curies per 

source and 

___curies total 

One source for medical use 

permitted by 10 CFR 35.600, 

in a Manufacturer 

__________________, Model 

No. _________ teletherapy 

unit. One source in its 

shipping container as 

necessary for replacement of 

the source in the teletherapy 

unit. 
 C–5 

Table C–1. Items 5 and 6 on NRC Form 313: Radioactive Material and Use (Continued) 

This response includes security-related sensitive information that is included in 

Attachment _____ and marked “Security-related information – withhold under 

10 CFR 2.390” ❑ Yes ❑ No

Radionuclide Form or Mfr/Mod No. Max Qty Purpose of Use

❒Cobalt-60 

permitted by 10 

CFR 35.600 

Sealed sources 

(Manufacturer 

______________, 

Model No. _____) 

___curies per 

source and 

___curies total 

For medical use permitted by 

10 CFR 35.600, in a 

Manufacturer 

__________________, Model 

No. _________ gamma 

stereotactic radiosurgery 

device. Sources in the 

shipping container as 

necessary for replacement of 

the sources in the gamma 

stereotactic radiosurgery 

device. 

❒Any byproduct 

material permitted 

by 10 CFR 31.11 

Prepackaged kits ___mCi In vitro studies. 

❒Depleted 

uranium 

Metal ___kilograms Shielding in a linear 

accelerator. 

❒Any radionuclide 

in excess of 30 

mCi for use in 

calibration. List 

radionuclide: 

_______________ 

Sealed source ___mCi For use in a Manufacturer 

__________________, Model 

No. _________ for 

calibrations and checking of 

licensee’s survey instruments. 

❒Americium-241 Sealed source 

(Manufacturer 

______________, 

Model No. _____) 

___mCi For use as an anatomical 

marker. 

❒Other Form or Manufacturer/ 

Model No. 

______________ 

___mCi Purpose of use 

___________________. 
 C–6 

Table C–2 contains a checklist that may be used to identify the attached documents that the 

applicant is supplying for items for which a response is required. For example, an applicant 

may fill in the name of the radiation safety officer (RSO) in Table C–2 and then check the boxes 

indicating which documents pertaining to the RSO are being included in the license application. 

An applicant may copy the checklist and include it in the license application. Personal 

information about employees or other individuals should not be submitted unless specifically 

requested by the NRC. Examples of private information are social security number, home 

address, home telephone number, date of birth, and radiation dose information. If private 

information is submitted, it should be separated from the public portion of the application and 

clearly marked: “Privacy Act Information—Withhold Under 10 CFR 2.390.” See Chapter 6, 

“Identifying and Protecting Sensitive Information,” for more information. 

 
 C–7 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

Item 7: Radiation Safety Officer (RSO) 

RSO Name: 

❒Listed on previous license as an RSO within the last 7 years 

 Provide NRC License #______________ or a copy of the license (if issued by an 

Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by 

an NRC Master Materials License broad scope 

OR 

❒Board certified by an NRC-recognized board 

 Attach copy of board certification which includes prescribed language and shows issuance 

within specified dates 

OR 

❒Has classroom/laboratory training and supervised radiation safety experience 

 Attach completed NRC Form 313A (RSO) or equivalent documentation 

AND 

❒Except for an RSO previously listed on a license/permit for the same types of uses, has 

radiation safety training for each type of medical use documented 

 Attach Table 3.c. of NRC Form 313A (RSO) or equivalent documentation 

 Attach Preceptor Attestation 

AND 

❒If applicable, recently received related training, if the original training and experience was 

received greater than 7 years ago 

AND 

❒For consultant-RSO or contractor, attach statements regarding the following:

 Commitments of the consultant-RSO for other NRC or Agreement State licensed facilities, 

along with a description of how the consultant-RSO will allocate time to permit the 

performance of the duties of the RSO as described in the regulations. The statement 

should include the consultant-RSO's minimum amount of onsite time (hours per week).

AND 

 Identification of an in-house representative who will serve as the point of contact during 

the RSO’s absence.

A description of the overall availability of the consultant-RSO to respond to questions or 

operational issues that arise during the conduct of radiation safety program and related 

regulatory requirements. Specification of the maximum amount of time it will take the RSO to 

arrive at the facility in the event of an emergency that requires his/her presence.
 C–8 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 7: Authorized Users (AUs) 

Authorized User(s) Name(s):

❒Provide state or territory where licensed 

❒Listed on previous license as an AU for the same type of use(s) requested within the 

last 7 years 

 Provide NRC License #______________ or a copy of the license (if issued by an 

Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by 

an NRC Master Materials License broad scope 

OR 

❒Board certified by an NRC-recognized board 

 Attach copy of board certification which includes prescribed language and shows issuance 

within specified dates 

OR 

❒ Has classroom/laboratory training and supervised radiation safety experience 

 Attach completed NRC Form 313A (AUD, AUT, AUS) or equivalent documentation 

AND 

❒Except for an AU previously listed on a license/permit for the same types of uses, has 

radiation safety training for each type of medical use documented 

 Attach casework experience for 10 CFR 35.300 

 Attach vendor training documentation or equivalent for each device requested under 

10 CFR 35.600 – see Table 3.e. of NRC Form 313A (AUS) 

 Attach Preceptor Attestation 

AND 

❒If applicable, recently received related training, if the original training and experience was 

received greater than 7 years ago 

❒For emerging technologies requested in accordance with 10 CFR 35.1000, documented 

training submitted in accordance with the applicable guidance found on the Medical Uses 

Licensee Toolkit. 

❒Listed on previous license as an AMP for the same type of use(s) requested within the last 

7 years 
 C–9 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 7: Authorized Medical Physicist (AMP) 

Authorized Medical Physicist(s) Name(s): 

 Provide NRC License #______________ or a copy of the license (if issued by an 

Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by 

an NRC Master Materials License broad scope 

OR 

❒Board certified by an NRC-recognized board 

 Attach copy of board certification which includes prescribed language and shows issuance 

within specified dates 

OR 

❒Has degree, medical physics training, and medical physics work experience 

 Attach completed NRC Form 313A (AMP) or equivalent documentation, which includes: 

— Master’s degree or doctorate in physics, medical physics, other physical science, 

engineering, or applied mathematics from an accredited college or university 

— Documentation of 1 year of full-time training in medical physics 

— Documentation of 1 year of full-time work experience in medical physics 

AND 

❒Except for an AU previously listed on a license/permit for the same types of uses, has 

radiation safety training for each type of medical use documented 

 Attach vendor training documentation or equivalent for each device requested under 10 

CFR 35.600 – see Table 3.e. of NRC Form 313A (AMP) 

 Attach Preceptor Attestation 

AND 

❒If applicable, recently received related training, if the original training and experience was 

received greater than 7 years ago 

❒For emerging technologies requested in accordance with 10 CFR 35.1000, documented 

training submitted in accordance with the applicable guidance found on the Medical Uses 

Licensee Toolkit. 

 
 C–10 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 7: Authorized Nuclear Pharmacist (ANP) 

Authorized Nuclear Pharmacist(s) Name(s):

❒Provide state or territory where licensed 

AND

❒Listed on previous license as an AMP for the same type of use(s) requested within the last 

7 years 

 Provide NRC License #______________ or a copy of the license (if issued by an 

Agreement State) or a copy of a permit issued by an NRC master materials licensee, a 

permit issued by an NRC or Agreement State broad scope licensee, or a permit issued by 

an NRC Master Materials License broad scope 

OR

❒Board certified by an NRC-recognized board 

 Attach copy of board certification which includes prescribed language and shows issuance 

within specified dates 

OR 

❒Has classroom/laboratory training and supervised practical experience in nuclear pharmacy 

 Attach completed NRC Form 313A (ANP) or equivalent documentation 

AND 

❒Except for an ANP previously listed on a license/permit, has radiation safety training for each 

type of medical use documented 

 Attach Preceptor Attestation 

AND 

❒If applicable, recently received related training, if the original training and experience was 

received greater than 7 years ago 

 
 C–11 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 8: Training for Individuals Working In or Frequenting Restricted Areas 

A response is not required. Refer to Section 8.8, “Training for Individuals Working in or 

Frequenting Restricted Areas.” 

Item 9: Facility Diagram 

❒A diagram(s) is enclosed that describes the facilities. For Positron Emission Tomography 

(PET), radiopharmaceutical therapy, manual brachytherapy, and all therapy devices, identify 

activities conducted in all contiguous areas surrounding the area(s) of use, including areas 

above and below. On the diagram, indicate: the scale used; the designated areas of use, 

storage, or preparation; room numbers; and principal use of each room and contiguous area. 

❒A diagram(s) is enclosed that describes therapy in-patient rooms for 10 CFR 35.300 and 

10 CFR 35.400 use. 

❒Guidance in Chapter 6, “Identifying and Protecting Sensitive Information,” was reviewed and 

security-related sensitive information provided is marked accordingly. 

❒Shielding calculations are enclosed for: 

 PET facilities

 In-patient rooms for 10 CFR 35.300 and 10 CFR 35.400 use

 High Dose-Rate/Pulsed Dose-Rate & Low Dose-Rate Remote Afterloaders

 Teletherapy

 Gamma stereotactic radiosurgery (GSR)

❒The shielding calculations include information about the type, thickness, and density of any 

necessary shielding to enable independent verification of shielding calculations, including a 

description of any portable shields used (e.g., shielding of proposed patient rooms used for 

implant therapy, including the dimensions of any portable shield, if one is used; source 

storage safe). The calculations also include the workload assumptions used. 

❒For teletherapy facilities direction(s) of primary beam use and, in the case of an isocentric 

unit, the plane of beam rotation is identified in the shielding calculations. 

❒Occupancy factors are provided for contiguous areas and whether surrounding areas are 

restricted or unrestricted as defined in 10 CFR 20.1003. For calculations of the maximum 

exposure in any given hour, an occupancy factor will not be used.

 
 C–12 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 9: Radiation Monitoring Instruments 

❒A statement that: “Radiation monitoring instruments will be calibrated by a vendor who is 

licensed by the NRC or an Agreement State to perform instrument calibrations.” 

AND/OR 

❒A statement that: “We have developed and will implement and maintain written radiation 

survey meter calibration procedures in accordance with the requirements in 10 CFR 20.1501 

and that meet the requirements of 10 CFR 35.61.” 

AND 

❒A description of the instrumentation (e.g., gamma counter, solid state detector, portable or 

stationary count rate meter, portable or stationary dose rate or exposure rate meter, single or 

multichannel analyzer, liquid scintillation counter, proportional counter) that will be used to 

perform required surveys. 

AND 

❒A statement that: “We reserve the right to upgrade our survey instruments as necessary as 

long as they are adequate to measure the type of level of radiation for which they are used.” 

Item 9: Dose Calibrator and Other Dosage Measuring Equipment 

For the administration of alpha-, gamma- and beta-emitting unsealed byproduct materials, we 

are providing the following: 

❒A statement that: “Equipment used to measure dosages will be calibrated in accordance with 

nationally recognized standards or the manufacturer’s instructions.” 

❒A description of the equipment used to measure the dosages. 

For alpha-emitters where gamma or beta emissions are not measureable: 

❒A statement that “Dosages will be determined by relying on the provider’s dose label for 

measurement of the radioactivity and a combination of volumetric measurement and 

mathematical calculation.” 

OR 

❒We are providing a description of the dosage measurement equipment, the nationally 

recognized calibration standard (or manufacturer’s calibration instructions), and dosage 

measurement procedures. 

 
 C–13 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 9: Therapy Unit - Calibration and Use 

❒We are providing the procedures required by 10 CFR 35.642, 10 CFR 35.643, and 

10 CFR 35.645, if applicable to the license application. 

Item 9: Other Equipment and Facilities 

❒Guidance in Chapter 6, “Identifying and Protecting Sensitive Information,” was reviewed and 

security-related sensitive information provided is marked accordingly. 

❒Attached is a description of additional facilities and equipment. 

❒For manual brachytherapy facilities, we are providing a description of the emergency 

response equipment. 

For teletherapy, GSR, and remote afterloader facilities, we are providing a description of the 

following: 

❒Warning systems and restricted area controls (e.g., locks, signs, warning lights and alarms, 

interlock systems) for each therapy treatment room; 

❒Area radiation monitoring equipment; 

❒Viewing and intercom systems (except for low dose-rate units); 

❒Steps that will be taken to ensure that no two units can be operated simultaneously, if other 

radiation-producing equipment (e.g., linear accelerator, x-ray machine) is in the treatment 

room; 

❒Methods to ensure that whenever the device is not in use or is unattended, the console keys 

will be inaccessible to unauthorized persons; and 

❒Emergency response equipment. 

Item 10: Emergency Procedures for Therapy Devices Containing Sealed Sources 

❒Attached are procedures required by 10 CFR 35.610. 

❒Guidance in Chapter 6, “Identifying and Protecting Sensitive Information,” was reviewed and 

security-related sensitive information provided is marked accordingly 

 
 C–14 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 10: Occupational Dose 

❒A statement that: “Either we will perform a prospective evaluation demonstrating that 

unmonitored individuals are not likely to receive, in a year, a radiation dose in excess of 10% 

of the allowable limits in 10 CFR Part 20 or we will provide dosimetry that meets the 

requirements listed under ‘Criteria’ in NUREG–1556, Vol. 9, ‘Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Medical Use Licenses.’ ” 

OR 

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

regulations. 

Item 10: Leak Tests 

❒No response is necessary, if leak testing is performed in-house. If a contractor is used to 

perform leak testing, a statement that: “Leak test sample collection and analysis will be 

performed by an organization authorized by the NRC or an Agreement State to provide leak 

testing services to other licensees; or by using a leak test sample collection kit supplied by an 

organization licensed by the NRC or an Agreement State to provide leak test kits and/or 

sample analysis services to other licensees and according to the instructions provided in the 

leak test sample collection kit.” 

Item 10: Area Surveys 

❒A statement that: “We have developed and will implement and maintain written procedures 

for area surveys in accordance with 10 CFR 20.1101 that meet the requirements of 10 CFR 

20.1501 and 10 CFR 35.70.” 

Item 10: Safe Use of Unsealed Licensed Material 

❒A statement that: “We have developed and will implement and maintain written procedures 

for safe use of unsealed byproduct material that meet the requirements of 10 CFR 20.1101 

and 10 CFR 20.1301.” 

Item 10: Spill/Contamination Procedures 

❒A statement that: “We have developed and will implement and maintain written procedures 

for safe response to spills of licensed material in accordance with 10 CFR 20.1101.” 

 
 C–15 

Table C–2. Items 7 Through 11 on NRC Form 313: Training and Experience, Facilities 

and Equipment, Radiation Protection Program, and Waste Disposal 

(Continued) 

Item 10: Installation, Maintenance, Adjustment, Repair, and Inspection of Therapy 

Devices Containing Sealed Sources 

❒Name of the proposed employee and types of activities requested: 

_____________________________________________________ 

_____________________________________________________ 

AND 

❒Description of the training and experience demonstrating that the proposed employee is 

qualified by training and experience for the use requested. 

AND 

❒Copy of the manufacturer’s training certification and an outline of the training in procedures to 

be followed. 

Item 10: Minimization of Contamination 

A response is not required under the following condition: The NRC will consider that the above 

criteria have been met if the information provided in applicant’s responses satisfies the criteria in 

Sections 8.9, 8.9.1, 8.10, 8.10.7, 8.10.15, and 8.11, on the topics: facilities and equipment, 

facility diagram, radiation protection program, safety program, and waste management. 

Item 11: Waste Management 

❒A statement that: “We have developed and will implement and maintain written waste 

disposal procedures for licensed material in accordance with 10 CFR 20.1101, that also meet 

the requirements of the applicable section of 10 CFR Part 20, Subpart K, and of 

10 CFR 35.92.” 

❒Attached is a description of the radioactive waste incinerator facility and related portions of 

the radiation safety program (10 CFR 20.2004). 

 
 C–16 

Table C–3 is provided to help applicants determine which procedures must be developed, 

implemented, and maintained for the type of medical use requested. Several appendices in this 

report present sample procedures that applicants may use in developing their procedures. 

Table C–3. Applicable Appendices Describing Model Procedures 

Appendix Topic 

35.100

35.200 35.300 35.400 35.500 35.600

G Dose Calibrator Calibration x X 

H Remote Afterloader Spot-Checks x 

I Radiation Safety Officer Duties, 

Responsibilities, and Delegation 

x X x x x 

J Training Program x X x x x 

K General Radiation Monitoring 

Instrument Specifications and 

Calibration 

x X x x x 

L Medical Licensee Audit x X x x x 

M Occupational Dose Program x X x x x 

N Emergency Procedures x X 

O Ordering and Receiving Packages x X x x x 

P Safely Opening Packages Containing 

Radioactive Material 

x X x x x 

Q Leak Tests x X x x x 

R Area Surveys x X x x x 

S Developing, Maintaining, and 

Implementing Written Directives 

 X x x 

T Safe Use of Unsealed Licensed 

Material 

x X 

U Release of Patients x X x 

V Mobile Medical Service x X x x 

W Waste Disposal x X x x x 

X Recordkeeping x X x x x 

Y Reporting x X x x x 

Z Transportation x X x x x 
1 APPENDIX D 

2 DOCUMENTATION OF TRAINING AND EXPERIENCE TO IDENTIFY 

3 INDIVIDUALS ON A LICENSE 

D–1 

1 Documentation of Training and Experience 

2 to Identify Individuals on a License 

3 Experienced Authorized Users, Authorized Medical Physicists, Authorized Nuclear Pharmacists, 

4 or Radiation Safety Officer 

5 An applicant or licensee who is adding an experienced authorized user (AU) for medical uses, 

6 authorized medical physicist (AMP), authorized nuclear pharmacist (ANP), or radiation safety 

7 officer (RSO) to its medical use license or application only needs to provide evidence that the 

8 individual is listed on a medical use license issued by the U.S. Nuclear Regulatory Commission 

9 (NRC) or Agreement State, a permit issued by an NRC master materials licensee, a permit 

10 issued by an NRC or Agreement State broad scope licensee, or a permit issued by an NRC 

11 master material broad scope permittee, provided that the individual is authorized for the same 

12 types of use(s) requested in the application under review and the individual meets the 

13 recentness of training criteria described in Title 10 of the Code of Federal Regulations (CFR) 

14 10 CFR 35.59, “Recentness of training.” When adding an experienced ANP to the license, the 

15 applicant also may provide evidence that the individual is listed on an NRC or Agreement State 

16 commercial nuclear pharmacy license or identified as an ANP by a commercial nuclear 

17 pharmacy authorized to identify ANPs. For individuals who have been previously authorized 

18 by, but not listed on, the commercial nuclear pharmacy license, medical broad scope license, 

19 or master materials license medical broad scope permit, the applicant should submit 

20 either verification of previous authorizations granted or evidence of acceptable training 

21 and experience. 

22 Experienced Physicians, Podiatrists, Dentists, Nuclear Pharmacists, Medical Physicists, and 

23 Radiation Safety Officers Who Only Used Accelerator-Produced Nuclear Materials, or Discrete 

24 Sources of Ra-226, or Both, for Medical or Nuclear Pharmacy Uses 

25 The NRC implemented a waiver for Naturally-Occurring and Accelerator-Produced Radioactive 

26 Material, which has expired. Specifically, the NRC “grandfathered” RSOs, physicians, 

27 podiatrists, dentists, medical physicists, and nuclear pharmacists that used only 

28 accelerator-produced radioactive materials, discrete sources of radium-226, or both, under 

29 states where the material was formerly licensed or registered need to apply under a different 

30 pathway listed in this section. 

31 Applications that Include Individuals for New Authorized User, Authorized Medical Physicist, 

32 Authorized Nuclear Pharmacist or Radiation Safety Officer Recognition by the NRC 

33 Applicants should submit the appropriate completed form in the NRC Form 313A series to show 

34 that the individuals meet the correct training and experience criteria in 10 CFR Part 35, 

35 Subparts B, D, E, F, G, and H. For the applicant’s convenience, the NRC Form 313A series has 

36 been separated into six separate forms. The forms are NRC Form 313A (RSO) for the 

37 Radiation Safety Officer; NRC Form 313A (AMP) for the authorized medical physicist; NRC 

38 Form 313A (ANP) for the authorized nuclear pharmacist; NRC Form 313A (AUD) for the 

39 authorized user of the medical uses included in 10 CFR 35.100, 35.200, and/or 35.500; NRC 

40 Form 313A (AUT) for the authorized user for the medical use included in 10 CFR 35.300; and 

41 NRC Form 313A (AUS) for the authorized user for the medical uses included in 10 CFR 35.400

42 and/or 35.600. 

43 There are two primary training and experience routes to qualify an individual as a new AU, 

44 AMP, ANP, or RSO. The first is by means of certification by a board recognized by the NRC 
D–2 

1 and listed on the NRC Web site as provided in 10 CFR 35.50(a), 35.51(a), 35.55(a), 35.190(a), 

2 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a). Preceptor 

3 attestations must also be submitted for all individuals to qualify under 10 CFR Part 35, Subparts 

4 B and D through H. Additional training may also need to be documented for RSOs, AMPs, and 

5 AUs under 10 CFR 35.600. 

6 The second route is by meeting the structured educational program, supervised work 

7 experience, and preceptor attestation requirements in 10 CFR Part 35, Subparts B, D, E, F, G, 

8 and H. In some cases, there may be additional training and experience routes for recognized 

9 AUs, ANPs, AMPs, or RSOs to seek additional authorizations. 

10 Recentness of Training 

11 The required training and experience, including board certification, described in 10 CFR Part 35

12 must be obtained within the 7 years preceding the date of the application, or the individual must 

13 document having had related continuing education, retraining, and experience since obtaining 

14 the required training and experience. Examples of acceptable continuing education and 

15 experience for physicians include the following: 

16  successful completion of classroom and laboratory review courses that include radiation 

17 safety practices relative to the proposed type of authorized medical use 

18  practical and laboratory experience with patient procedures using radioactive material for 

19 the same use(s) for which the applicant is requesting authorization 

20  practical and laboratory experience under the supervision of an AU at the same or 

21 another licensed facility that is authorized for the same use(s) for which the applicant is 

22 requesting authorization 

23  for therapy devices, experience with the therapy unit and/or comparable linear 

24 accelerator experience and completion of an in-service review of operating and 

25 emergency procedures relative to the therapy unit to be used by the applicant 

26 General Instructions and Guidance for Filling Out NRC Form 313A Series 

27 If the applicant is proposing an individual for more than one type of authorization, the applicant 

28 may need to either submit multiple forms in the NRC Form 313A series or fill out some sections 

29 more than once. For example, an applicant that requests a physician be authorized for 

30 10 CFR 35.200 and 10 CFR 35.300 medical uses and as the RSO, should provide three 

31 completed NRC Form 313A series forms [i.e., NRC Form 313A (RSO), NRC Form 313A (AUD) 

32 and NRC Form 313A (AUT)]. Also, if the applicant requests that a physician be authorized for 

33 both HDR remote afterloader and gamma stereotactic radiosurgery (GSR) under 10 CFR 

34 35.600, only NRC Form 313A (AUS) needs to be completed, but one part (i.e., “Supervised 

35 Work and Clinical Experience”) must be filled out twice. 

36 To identify an Agreement State license, provide a copy of the license. To identify a Master 

37 Materials License permit, provide a copy of the permit. To identify an individual 

38 (i.e., supervising individual or preceptor) who is authorized under a broad scope license or 

39 broad scope permit of a Master Materials License, provide a copy of the permit issued by the 

40 broad scope licensee/permittee. Alternatively, provide a statement signed by the RSO or 

41 chairperson of the RSC similar to the following: “__________ (name of supervising individual or 
D–3 

1 preceptor) is authorized under _______________ (name of licensee/permittee) broad scope 

2 license number__________ to use_________ (materials) during ____________ (time frame).” 

3 INTRODUCTORY INFORMATION 

4 Name of Individual 

5 Provide the individual’s complete name so that the NRC can distinguish the training and 

6 experience received from that received by others with a similar name. 

7 Note: Do not include personal or private information (e.g., date of birth, social security number, 

8 home address, personal telephone number) as part of your qualification documentation. 

9 State or Territory Where Licensed 

10 The NRC requires physicians, dentists, podiatrists, and pharmacists to be licensed by a State or 

11 territory of the U.S., the District of Columbia, or the Commonwealth of Puerto Rico to prescribe 

12 drugs in the practice of medicine, as well as licensed in the practice of dentistry, podiatry, or 

13 pharmacy, respectively (see definitions of “physician,” “dentist,” “podiatrist,” and “pharmacist” in 

14 10 CFR 35.2, “Definitions”).

15 Requested Authorization(s) 

16 Check all authorizations that apply and fill in the blanks as provided. 

17 Part I. Training and Experience 

18 There are always multiple pathways provided for each training and experience section. Select 

19 the applicable one. 

20 Item 1. Board Certification 

21 The applicant or licensee may use this pathway if the proposed new authorized individual is 

22 certified by a board recognized by the NRC. Specialty board certifications recognized by the 

23 NRC are posted on the Medical Uses Licensee Toolkit. 

24 Note: An individual that is board-eligible will not be considered for this pathway until the 

25 individual is actually board-certified. Further, individuals holding board certifications other than 

26 those listed on the Medical Uses Licensee Toolkit will also not be considered for this pathway. 

27 The applicant or licensee will need to provide a copy of the board certification and other 

28 documentation of training, experience, or clinical casework, as indicated on the specific form of 

29 the NRC Form 313A series. 

30 All applicants under this pathway (except for 10 CFR 35.500 uses) must submit a completed 

31 Part II Preceptor Attestation. 

32 Item 2. Current Authorized Individuals Seeking Additional Authorizations 

33 Provide the information requested for training, experience, or clinical casework, as indicated on 

34 the specific form of the NRC Form 313A series. (Note: This section does not include 

35 individuals who are authorized only on foreign licenses.) 
D–4 

1 All applicants under this pathway must submit a completed Part II Preceptor Attestation. 

2 Item 3. Alternate Pathway for Training and Experience for Proposed New 

3 Authorized Individuals 

4 This pathway is used for those individuals not listed on the license as authorized individuals or 

5 do not meet the requirements for the board certification pathway. 

6 The regulatory requirements refer to two categories of training: (i) classroom and laboratory 

7 training, and (ii) supervised work experience. All hours credited to classroom and laboratory 

8 training must relate directly to radiation safety and safe handling of byproduct material and be 

9 allocated to one of the topics in the regulations. Each hour of training involving performance of 

10 radiation safety tasks or hands-on use of byproduct material may be credited to either 

11 (i) classroom and laboratory training, or (ii) supervised work experience. Note that a single hour 

12 of training may only be counted once and may not be credited to both of these categories. 

13 The proposed authorized individual may receive the required classroom and laboratory training, 

14 supervised work experience, and clinical casework at a single training facility or at multiple 

15 training facilities; therefore, space is provided to identify each location and date of training or 

16 experience. The date should be provided in the month/day/year (mm/dd/yyyy) format. 

17 The specific number of hours needed for each training and supervised work experience element 

18 will depend upon the type of approval sought. Under the “classroom and laboratory training,” 

19 provide the number of clock hours spent on each of the topics listed in the regulatory 

20 requirements. 

21 The proposed authorized individual may obtain the required “classroom and laboratory training” 

22 in any number of settings, locations, and educational situations. For example, at some medical 

23 teaching/university institutions, a course may be provided for that particular need and taught in 

24 consecutive days. In other training programs, the period may be a semester or quarter as part 

25 of the formal curriculum. Also, the classroom and laboratory training may be obtained using a 

26 variety of other instructional methods. Therefore, the NRC will broadly interpret “classroom and 

27 laboratory training” to include various types of instruction, including online training, as long as it 

28 meets the specific clock hour requirements and the subject matter relates to radiation safety and 

29 safe handling of byproduct material for the uses requested. 

30 Under the “supervised work experience” sections of the forms, provide only the total number of 

31 hours of supervised work experience and check the boxes for each of the topics listed in the 

32 regulatory requirements to confirm that the listed subject areas were included in the supervised 

33 work experience. 

34 The “supervised work experience” for physicians must include, but is not limited to, the subject 

35 areas listed in the applicable training and experience requirements. The NRC recognizes that 

36 physicians in training will not dedicate all of their supervised work experience time specifically to 

37 the subject areas listed in the regulatory requirements and will be attending to other clinical 

38 activities involving the medical use of byproduct material (e.g., reviewing case histories or 

39 interpreting scans). Hours spent on these other duties not directly related to radiation safety or 

40 hands-on use of byproduct material, even though not specifically required by the NRC, may be 

41 credited to the supervised work experience category but not to the classroom and laboratory 

42 training category. 
D–5 

1 For nuclear pharmacists, under the “supervised practical experience” section, provide the 

2 number of clock hours for each topic. The supervised practical experience topics for the nuclear 

3 pharmacists include all the basic elements in the practice of nuclear pharmacy. Therefore, all 

4 the hours of supervised experience are allocated to these topics. 

5 Note: If the proposed new authorized individual had more than one supervisor, provide the 

6 information requested for each supervising individual. 

7 Part II. Preceptor Attestation 

8 The NRC defines the term “preceptor” in 10 CFR 35.2, “Definitions,” to mean “an individual who 

9 provides, directs, or verifies training and experience required for an individual to become an AU, 

10 an AMP, an ANP, or an RSO.” While the supervising individual for the work experience may 

11 also be the preceptor, the preceptor does not have to be the supervising individual as long as 

12 the preceptor directs or verifies the training and experience required. The preceptor must attest 

13 in writing regarding the training and experience of any individual to serve as an authorized 

14 individual and attest that the individual has satisfactorily completed the appropriate training and 

15 experience requirements and has achieved a level of competency or a level of radiation safety 

16 knowledge sufficient to function independently. The preceptor language in NRC Forms 

17 313A (AUD), 313A (AUT), and 313A (AUS) does not require an attestation of general clinical 

18 competency but requires sufficient attestation to demonstrate that the individual has the 

19 knowledge to fulfill the duties of the position for which the attestation is sought. The preceptor 

20 also has to meet specific requirements. 

21 The NRC may require supervised work experience conducted under the supervision of an 

22 authorized individual in a licensed material use program. In this case, a supervisor is an 

23 individual who provides frequent direction, instruction, and direct oversight of the student as the 

24 student completes the required work experience in the use of byproduct material. 

25 Supervision may occur at various licensed facilities, from a large teaching university hospital to 

26 a small private practice. 

27 The NRC Form 313A series Part II - Preceptor Attestation has multiple sections. The preceptor 

28 must complete an attestation of the proposed user’s training, experience, and competency to 

29 function independently, as well as provide information concerning his/her own qualifications and 

30 sign the attestation. Because there are a number of different pathways to obtain the required 

31 training and experience for different authorized individuals, specific instructions are provided 

32 below for each form in the NRC 313A series. 

33 VI. RADIATION SAFETY OFFICER - Specific Instructions and Guidance for Filling Out 

34 NRC Form 313A (RSO) 

35 See Section V, “General Instructions and Guidance for Filling out NRC Form 313A Series,” for 

36 additional clarification on providing information about an individual’s status on an Agreement 

37 State license, medical broad scope license, or Master Materials License permit. 

38 Part I. Training and Experience - Select One of Four Methods Below: 

39 Item 1. Board Certification 
D–6 

1 Provide the requested information (i.e., a copy of the board certification, documentation of 

2 specific radiation safety training for all types of use on the license, and a completed preceptor 

3 attestation). As indicated on the form, additional information is needed if the board certification 

4 or radiation safety training was completed more than 7 years ago. 

5 Specific radiation safety training for each type of use on the license may be supervised by an 

6 RSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding 

7 the supervising individual only needs to be provided in the table in 3.c if the training was 

8 provided by an RSO, AMP, ANP, or AU. If more than one supervising individual provided the 

9 training, identify each supervising individual by name and provide his or her qualifications. 

10 Item 2. Current Radiation Safety Officer Seeking Authorization to Be Recognized as a 

11 Radiation Safety Officer for the Additional Medical Use(s) Checked Above 

12 Provide the requested information [i.e., documentation of specific radiation safety training 

13 (complete the table in 3.c) and a completed preceptor attestation in Part II]. As indicated on the 

14 form, additional information is needed if the specific radiation safety training was completed 

15 more than 7 years ago. 

16 Specific radiation safety training for each type of use on the license may be supervised by an 

17 RSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding 

18 the supervising individual only needs to be provided in the table in 3.c if the training was 

19 provided by an RSO, AMP, ANP, or AU. If more than one supervising individual provided the 

20 training, identify each supervising individual by name and provide his or her qualifications. 

21 Item 3. Structured Educational Program for Proposed New Radiation Safety Officer 

22 As indicated on the form, additional information is needed if the training, supervised radiation 

23 safety experience, and specific radiation safety training was completed more than 7 years ago. 

24 Submit a completed Section 3.a. 

25 Submit a completed Section 3.b. The individual must have completed 1 year of full-time 

26 radiation safety experience under the supervision of an RSO. This is documented in Section 

27 3.b by providing the ranges of dates for supervised radiation safety experience. If there was 

28 more than one supervising individual, identify each supervising individual by name and provide 

29 his or her qualifications. 

30 Provide the requested information [i.e., documentation of specific radiation safety training for 

31 each use on the license (complete the table in 3.c)]. Specific radiation safety training for each 

32 type of use on the license may be supervised by an RSO, AMP, ANP, or AU who is authorized 

33 for that type of use. Specific information regarding the supervising individual only needs to be 

34 provided in the table in 3.c if the training was provided by an RSO, AMP, ANP, or AU. If more 

35 than one supervising individual provided the training, identify each supervising individual by 

36 name and provide his or her qualifications. 

37 Submit a completed Preceptor Attestation in Part II. 

38 Item 4. Authorized User, Authorized Medical Physicist, or Authorized Nuclear Pharmacist 

39 Identified on the Licensee’s License 
D–7 

1 Provide the requested information [i.e., the license number and documentation of specific 

2 radiation safety training for each use on the license (complete the table in 3.c)]. As indicated on 

3 the form, additional information is needed if the specific radiation safety training was completed 

4 more than 7 years ago. 

5 Specific radiation safety training for each type of use on the license may be supervised by an 

6 RSO, AMP, ANP, or AU who is authorized for that type of use. Specific information regarding 

7 the supervising individual only needs to be provided in the table in 3.c if the training was 

8 provided by an RSO, AMP, ANP, or AU. If more than one supervising individual provided the 

9 training, identify each supervising individual by name and provide his or her qualifications. 

10 Part II. Preceptor Attestation 

11 The Preceptor Attestation page has four sections. 

12 The attestation for the new proposed RSO’s training or identification on the license as an AU, 

13 AMP, or ANP is in the first section. 

14 The attestation for the specific radiation safety training is in the second section. 

15 The attestation for the individual’s competency to function independently as an RSO for a 

16 medical use license is in the third section. 

17 The fourth and final section requests specific information about the preceptor’s authorization as 

18 an RSO on a medical use license, in addition to the preceptor’s signature. 

19 The preceptor for a new proposed RSO must fill out all four sections. 

20 The preceptor for an RSO seeking authorization to be recognized as an RSO for the additional 

21 medical use(s) must fill out the second, third, and fourth sections. 

22 VII. AUTHORIZED MEDICAL PHYSICIST - Specific Instructions and Guidance for 

23 Filling Out NRC Form 313A (AMP) 

24 See Section V, “General Instructions and Guidance for Filling Out NRC Form 313A Series,” for 

25 additional clarification on providing information about an individual’s status on an Agreement 

26 State license, medical broad scope license, or Master Materials License permit. 

27 Part I. Training and Experience - Select one of the Three Methods Below: 

28 Item 1. Board Certification 

29 Provide the requested information (i.e., a copy of the board certification, documentation of 

30 device-specific training in the table in 3.c, and a completed Preceptor Attestation). As indicated 

31 on the form, additional information is needed if the board certification or device-specific training 

32 was completed more than 7 years ago. 

33 Device-specific training may be provided by the vendor or a supervising medical physicist 

34 authorized for the requested type of use. Specific information regarding the supervising 

35 individual only needs to be provided in the table in 3.c if the training was provided by an AMP. If 
D–8 

1 more than one supervising individual provided the training, identify each supervising individual 

2 by name and provide his or her qualifications. 

3 Item 2. Current Authorized Medical Physicist Seeking Additional Uses(s) Checked above 

4 Provide the requested information (i.e., documentation of device-specific training (complete the 

5 table in 3.c) and complete the Preceptor Attestation in Part II). As indicated on the form, 

6 additional information is needed if the device-specific training was completed more than 7 years 

7 ago. 

8 Device-specific training may be provided by the vendor or a supervising medical physicist 

9 authorized for the requested type of use. Specific information regarding the supervising 

10 individual only needs to be provided in the table in 3.c if the training was provided by an AMP. If 

11 more than one supervising medical physicist provided the training, identify each supervising 

12 individual by name and provide his or her qualifications. 

13 Item 3. Training and Experience for Proposed Authorized Medical Physicist 

14 As indicated on the form, additional information is needed if the degree, training, and/or work 

15 experience was completed more than 7 years ago. 

16 Submit a completed Section 3.a. Submit documentation of a graduate degree (for example, a 

17 copy of a diploma or transcript from an accredited college or university). 

18 Submit a completed Section 3.b. The individual must have completed 1 year of full-time training 

19 in medical physics and an additional year of full-time work experience, which cannot be 

20 concurrent. This is documented in Section 3.b by providing the ranges of dates for training and 

21 work experience. 

22 If the proposed AMP had more than one supervisor, provide the information requested in 

23 Section 3.b for each supervising individual. If the supervising individual is not an AMP, the 

24 applicant must provide documentation that the supervising individual meets the requirements in 

25 10 CFR 35.51, “Training for an authorized medical physicist,” and 10 CFR 35.59, “Recentness 

26 of training.” 

27 Submit a completed Section 3.c for each specific device for which the applicant is requesting 

28 authorization. 

29 Device-specific training may be provided by the vendor or a supervising medical physicist 

30 authorized for the requested type of use. Specific information regarding the supervising 

31 individual only needs to be provided in the table in 3.c if the training was provided by an AMP. If 

32 more than one supervising medical physicist provided the training, identify each supervising 

33 individual by name and provide his or her qualifications. 

34 Submit a completed Preceptor Attestation in Part II. 

35 Part II. Preceptor Attestation 

36 The Preceptor Attestation page has four sections. 

37 The attestation to the proposed AMP’s training is in the first section. 
D–9 

1 The attestation for the device-specific training is in the second section. 

2 The attestation of the individual’s competency to function independently as an AMP for the 

3 specific devices requested by the applicant is in the third section. 

4 The fourth and final section requests specific information about the preceptor’s authorizations to 

5 use licensed material, in addition to the preceptor’s signature. 

6 The preceptor for a proposed new AMP must fill out all four sections of this page. The 

7 preceptor for an AMP seeking additional authorizations must complete the last three sections. 

8 VIII. AUTHORIZED NUCLEAR PHARMACIST - Specific Instructions and Guidance 

9 for Filling Out NRC Form 313A (ANP) 

10 See Section V, “General Instructions and Guidance for Filling out NRC Form 313A Series,” for 

11 additional clarification on providing information about an individual’s status on an Agreement 

12 State license, medical broad scope license, or Master Materials License permit. 

13 Part I. Training and Experience - Select One of the Two Methods Below: 

14 Item 1. Board Certification 

15 Provide the requested information (i.e., a copy of the board certification and a completed 

16 Preceptor Attestation). As indicated on the form, additional information is needed if the board 

17 certification occurred more than 7 years ago. 

18 Item 2. Structured Educational Program for a Proposed Authorized Nuclear Pharmacist 

19 As indicated on the form, additional information is needed if the training and/or supervised 

20 practical experience was completed more than 7 years ago. 

21 Submit completed Sections 2.a and 2.b. If the proposed new nuclear pharmacist had more than 

22 one supervisor, provide the name of each supervising individual in Section 2.b. 

23 Submit a completed Preceptor Attestation. 

24 Part II. Preceptor Attestation 

25 The Preceptor Attestation page has two sections. The preceptor must select either the board 

26 certification or the structured educational program when filling out the first section on this page. 

27 The second and final section of the page requests specific information about the preceptor’s 

28 authorization to use licensed material, in addition to the preceptor’s signature. 

29 IX. 10 CFR 35.100, 35.200, AND 35.500 AUTHORIZED USERS - Specific Instructions and 

30 Guidance for Filling Out NRC Form 313A (AUD) 

31 See Section V, “General Instructions and Guidance for Filling out NRC Form 313A Series,” for 

32 additional clarification on providing information about an individual’s status on an Agreement 

33 State license, medical broad scope license, or Master Materials License permit. 
D–10 

1 Part I. Training and Experience - select one of the three methods below: 

2 Item 1. Board Certification 

3 Provide the requested information (i.e., a copy of the board certification and a completed 

4 Preceptor Attestation). As indicated on the form, additional information is needed if the board 

5 certification occurred more than 7 years ago. 

6 Item 2. Current 35.390 Authorized User Seeking Additional 10 CFR 35.290 Authorization 

7 (a) Fill in the blank in Section 2.a with the current license number on which the proposed user is 

8 listed. 

9 (b) Provide a description of the proposed user’s experience that meets the requirements of 

10 10 CFR 35.290(c)(1)(ii)(G) as shown in the table in 2.b. As indicated on the form, additional 

11 information is needed if this experience was obtained more than 7 years ago. 

12 List each supervising individual by name, and include the license showing the supervising 

13 individual as an AU. 

14 Item 3. Training and Experience for Proposed Authorized Users 

15 As indicated on the form, additional information is needed if the training and/or work experience 

16 was completed more than 7 years ago. 

17 Note: Providing the training and experience information required under 10 CFR 35.290 will 

18 allow the individual to be authorized to use materials permitted by both 10 CFR 35.100 and 

19 10 CFR 35.200. 

20 Submit a completed Section 3.a for each proposed authorized use. 

21 Submit a completed Section 3.b, except for 10 CFR 35.500 uses. If the proposed user had 

22 more than one supervisor, provide the information requested in Section 3.b for each supervising 

23 individual. 

24 Submit a completed Section 3.c for 10 CFR 35.500 uses. 

25 Submit a completed Preceptor Attestation, except for 10 CFR 35.500 uses. 

26 Part II. Preceptor Attestation 

27 The Preceptor Attestation page has two sections. The attestations for training and experience 

28 requirements in 10 CFR 35.190 and 10 CFR 35.290 are found in the first section. The second 

29 and final section requests specific information about the preceptor’s authorization(s) to use 

30 licensed material, in addition to the preceptor’s signature. The preceptor must fill out both 

31 sections. 

32 Note: The attestation to the proposed user’s training and competency to function independently 

33 under 10 CFR 35.190 covers the use of material permitted by 10 CFR 35.100 only. The 

34 attestation for the proposed user’s training and competency to function independently under 

35 10 CFR 35.290 will allow the individual to be authorized to use material permitted by both 

36 10 CFR 35.100 and 10 CFR 35.200. 
D–11 

1 X. 35.300 AUTHORIZED USER - Specific Instructions and Guidance for Filling Out NRC 

2 Form 313A (AUT) 

3 See Section V, “General Instructions and Guidance for Filling out NRC Form 313A Series,” for 

4 additional clarification on providing information about an individual’s status on an Agreement 

5 State license, medical broad scope license, or Master Materials License permit. 

6 Part I. Training and Experience - select one of the three methods below: 

7 Item 1. Board Certification 

8 If the applicant is a nuclear medicine physician, radiologist, or radiation oncologist with a board 

9 certification listed under 10 CFR 35.300 on NRC’s Web site, provide the requested information 

10 [i.e., a copy of the board certification, documentation of supervised clinical experience (complete 

11 the table in section 3.c), and a completed Preceptor Attestation]. As indicated on the form, 

12 additional information is needed if the board certification or supervised clinical experience 

13 occurred more than 7 years ago. List each supervising individual by name and include the 

14 license showing the supervising individual as an AU. 

15 If the applicant is a radiation oncologist whose board certification is not listed under 

16 10 CFR 35.300 on NRC’s Web site, provide the requested information (i.e., a copy of the board 

17 certification listed under either 10 CFR 35.400 or 10 CFR 35.600 on NRC’s Web site, 

18 documentation of training and supervised work experience with unsealed materials requiring a 

19 written directive (WD) (complete the tables in Sections 3.a and 3.b), documentation of 

20 supervised clinical experience (complete the table in Section 3.c), and a completed Preceptor 

21 Attestation). As indicated on the form, additional information is needed if the board certification, 

22 training, and supervised work experience or clinical experience occurred more than 7 years ago. 

23 List each supervising individual by name, and include the license showing the supervising 

24 individual as an AU. 

25 Item 2. Current 10 CFR 35.300, 10 CFR 35.400, or 10 CFR 35.600 Authorized User Seeking 

26 Additional Authorization 

27 Submit a completed Section 2.a, listing the license number and the user’s current 

28 authorizations. 

29 If the applicant is currently authorized for a subset of clinical uses under 10 CFR 35.300, submit 

30 the requested information (i.e., complete the table in Section 3.c to document the new 

31 supervised clinical case experience and the completed Preceptor Attestation). As indicated on 

32 the form, additional information is needed if the clinical case experience occurred more than 

33 7 years ago. List each supervising individual by name, and include the license showing the 

34 supervising individual as an AU. 

35 If the applicant is currently authorized under 10 CFR 35.490 or 10 CFR 35.690 and meets the 

36 requirements in 10 CFR 35.396, submit the requested information (i.e., documentation of 

37 training and supervised work experience with unsealed materials requiring a WD (complete the 

38 tables in Sections 3.a and 3.b), documentation of supervised clinical experience (complete the 

39 table in Section 3.c), and a completed Preceptor Attestation). As indicated on the form, 

40 additional information is needed if the training and supervised work experience or clinical 

41 experience occurred more than 7 years ago. List each supervising individual by name and 

42 include the license showing the supervising individual as an AU. 
D–12 

1 Item 3. Training and Experience for Proposed Authorized Users 

2 As indicated on the form, additional information is needed if the degree, training, and/or work 

3 experience was completed more than 7 years ago. 

4 Submit a completed Section 3.a. 

5 Submit a completed Section 3.b. List each supervising individual by name and include the 

6 license number showing the supervising individual as an AU. 

7 Submit a completed Section 3.c for each requested authorization. List each supervising 

8 individual by name and include the license number showing the supervising individual as an AU. 

9 Submit a completed Preceptor Attestation in Part II. 

10 Part II. Preceptor Attestation 

11 The Preceptor Attestation page has five sections. 

12 The attestations for training and experience requirements in 10 CFR 35.390, 10 CFR 35.392, 

13 and 10 CFR 35.394 are in the first section. 

14 The attestation for supervised clinical experience is in the second section. 

15 The attestations for competency to function independently as an AU for specific uses are in the 

16 third section. 

17 The attestation for training and experience requirements and competency to function 

18 independently for a radiation oncologist meeting the requirements in 10 CFR 35.396 is in the 

19 fourth section. 

20 The fifth and final section requests specific information about the preceptor’s authorization(s) to 

21 use licensed material, in addition to the preceptor’s signature. 

22 There are seven possible categories of individuals seeking AU status under this form. Follow 

23 the instructions for the applicable category. 

24 The preceptor for a proposed AU who is a nuclear medicine physician, radiologist, or radiation 

25 oncologist with a board certification listed under 10 CFR 35.390 on the Medical Uses Licensee 

26 Toolkit must complete the first, second, third, and fifth sections. 

27 The preceptor for a proposed AU for all the uses listed in 10 CFR 35.390(b)(1)(ii)(G) who is a 

28 radiation oncologist with a board certification that is not listed under 10 CFR 35.390 on the 

29 Medical Uses Licensee Toolkit must complete the first, second, third, and fifth sections. 

30 The preceptor for a proposed AU for 10 CFR 35.390(b)(1)(ii)(G)(iii) and (iv) uses who is a 

31 radiation oncologist with a board certification listed under 10 CFR 35.490 or 10 CFR 35.690 on 

32 the Medical Uses Licensee Toolkit must complete the fourth and fifth sections. 

33 The preceptor for an AU who is currently authorized for a subset of clinical uses under 

34 10 CFR 35.300 must complete the second, third, and fifth sections of this part, except for an AU 
D–13 

1 meeting the criteria in 10 CFR 35.392 seeking to meet the training and experience requirements 

2 under 10 CFR 35.394. 

3 The preceptor for an AU meeting the criteria in 10 CFR 35.392 seeking to meet the training and 

4 experience requirements under 10 CFR 35.394 must complete the first, second, third, and fifth 

5 sections. 

6 The preceptor for an AU currently authorized under 10 CFR 35.490 or 10 CFR 35.690 and 

7 meeting the requirements in 10 CFR 35.396 must complete the fourth and fifth sections. 

8 The preceptor for a proposed new AU must complete the first, second, third, and fifth sections. 

9 XI. 35.400 AND 35.600 AUTHORIZED USERS - Specific Instructions and Guidance for 

10 Filling Out NRC Form 313A (AUS) 

11 See Section V, “General Instructions and Guidance for Filling out NRC Form 313A Series,” for 

12 additional clarification on providing information about an individual’s status on an Agreement 

13 State license, medical broad scope license, or Master Materials License permit. 

14 Part I. Training and Experience - select one of the three methods below: 

15 Item 1. Board Certification 

16 Provide the requested information (i.e., a copy of the board certification) for 10 CFR 35.600

17 uses, documentation of device-specific training in the table in 3.e, and for all uses, a completed 

18 Preceptor Attestation. As indicated on the form, additional information is needed if the board 

19 certification or device-specific training was completed more than 7 years ago. 

20 Device-specific training may be provided by the vendor for new users or either a supervising AU 

21 or an AMP authorized for the requested type of use. Specific information regarding the 

22 supervising individual only needs to be provided in the table in 3.e if the training was provided 

23 by an AU or AMP. If more than one supervising individual provided the training, identify each 

24 supervising individual by name and provide his or her qualifications. 

25 Item 2. Current 10 CFR 35.600 Authorized User Requesting Additional Authorization for 10 

26 CFR 35.600 Use(s) Checked Above 

27 Provide the requested information [i.e., documentation of device-specific training (complete the 

28 table in 3.e)] and a completed Preceptor Attestation in Part II. As indicated on the form, 

29 additional information is needed if the device-specific training was completed more than 7 years 

30 ago. 

31 Device-specific training may be provided by the vendor, a supervising AU, or an AMP 

32 authorized for the requested type of use. Specific information regarding the supervising 

33 individual only needs to be provided in the table in 3.e if the training was provided by an AU or 

34 AMP. If more than one supervising individual provided the training, identify each supervising 

35 individual by name and provide his or her qualifications. 
D–14 

1 Item 3. Training and Experience for Proposed Authorized Users 

2 As indicated on the form, additional information is needed if the training, residency program, 

3 supervised work, and clinical experience were completed more than 7 years ago. 

4 Submit a completed Section 3.a for each requested use. 

5 Submit a completed Section 3.b if applying for 10 CFR 35.400 uses. However, Section 3.b 

6 does not have to be completed when only applying for use of strontium-90 (Sr-90) for 

7 ophthalmic use. If more than one supervising AU provided the supervised work and clinical 

8 experience, identify each supervising individual by name and provide his/her qualifications. 

9 Submit a completed Section 3.c if only applying for use of Sr-90 for ophthalmic use. If more 

10 than one supervising AU provided the supervised clinical experience, identify each supervising 

11 individual by name and provide his or her qualifications. 

12 Submit a completed Section 3.d for each requested 10 CFR 35.600 use. If more than one 

13 supervising AU provided the supervised work and clinical experience, identify each supervising 

14 individual by name and provide his or her qualifications. 

15 Submit a completed Section 3.e for each specific 10 CFR 35.600 device for which the applicant 

16 is requesting authorization. 

17 Device-specific training may be provided by the vendor, a supervising AU, or an AMP 

18 authorized for the requested type of use. Specific information regarding the supervising 

19 individual only needs to be provided in the table in 3.e if the training was provided by an AU or 

20 AMP. If more than one supervising individual provided the training, identify each supervising 

21 individual by name and provide his or her qualifications. 

22 Submit a completed Preceptor Attestation in Part II. 

23 Part II. Preceptor Attestation 

24 The Preceptor Attestation part has five sections. 

25 The attestation to the training and individual’s competency for 10 CFR 35.400 uses or Sr-90 eye 

26 applicator use is in the first section. 

27 The attestation to the training for the proposed AU for 10 CFR 35.600 uses is in the second 

28 section. 

29 The attestation for the 10 CFR 35.600 device-specific training is in the third section. 

30 The attestation of the individual’s competency to function independently as an AU for the 

31 specific 10 CFR 35.600 devices requested by the applicant is in the fourth section. 

32 The fifth and final section requests specific information about the preceptor’s authorization(s) to 

33 use licensed material, in addition to the preceptor’s signature. 

34 The preceptor for a 10 CFR 35.400 proposed AU must fill out the first and fifth sections. 
D–15 

1 The preceptor for a 10 CFR 35.600 proposed AU must fill out the second, third, fourth, and 

2 fifth sections. 

3 The preceptor for an AU seeking additional 10 CFR 35.600 authorizations must complete the 

4 third, fourth, and fifth sections. 

1 APPENDIX E 

2 U.S. NUCLEAR REGULATORY COMMISSION FORM 313A (AUD) 

E–1 

U.S. Nuclear Regulatory Commission Form 313A (AUD) 

Please use the most current version of this form, which may be found at: 

http://www.nrc.gov/reading-rm/doc-collections/forms/ 
E–2 
E–3 
E–4 
1 APPENDIX F 

2 CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

3 INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390) 

F–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 (CFR) 10 CFR 2.390, “Public Inspections, Exemptions, 

Requests for Withholding.” The applicant should submit all of the following: 

 A proprietary copy of the information. Brackets should be placed around the material considered 

to be proprietary. This copy should be marked as proprietary. 

 A non-proprietary copy of the information. Applicants should white out or black out the proprietary 

portions (i.e., those in the brackets), leaving the nonproprietary portions intact. This copy should 

not be marked as proprietary. 

 An affidavit that: 

 Is notarized. 

 Clearly identifies (such as by name or title and date) the document to be withheld. 

 Clearly identifies the position of the person executing the affidavit. This person must be an 

officer or upper-level management official who has been delegated the function of reviewing 

the information the organization is seeking to withhold and is authorized to apply for 

withholding on behalf of the organization. 

 States that the organization submitting the information is the owner of the information or is 

required, by agreement with the owner of the information, to treat the information as 

proprietary. 

 Provides a rational basis for holding the information in confidence. 

 Fully addresses the following issues: 

 Is the information submitted to, and received by, the NRC in confidence? Provide 

details. 

 To the best of the applicant’s knowledge, is the information currently available in public 

sources? 

 Does the applicant customarily treat this information, or this type of information, as 

confidential? Explain why. 

 Would public disclosure of the information be likely to cause substantial harm to the 

competitive position of the applicant? If so, explain why in detail. The explanation 

should include the value of the information to your organization, the amount of effort or 

money expended in developing the information, and the ease or difficulty for others to 

acquire the information. 

1 APPENDIX G 

2 MODEL PROCEDURES FOR DOSE CALIBRATOR CALIBRATION 

G–1 

1 Model Procedures for Dose Calibrator Calibration 

2 The model procedure provides acceptable methods for dose calibrator testing when measuring 

3 photon-emitting radionuclides. Applicants may either adopt this model procedure or develop an 

4 alternative procedure in accordance with manufacturer’s instructions or a nationally 

5 recognized standard. 

6 The tests should be performed at the indicated frequency: 

7  constancy, at least once each day prior to assay of patient dosages (+/- 10%) 

8  linearity, at installation and at least annually thereafter (+/- 10%) 

9  geometry dependence, at installation (+/- 10%) 

10  accuracy, at installation and at least annually thereafter (+/- 10%) 

11 The dose calibrator will be repaired, replaced, or corrected arithmetically if the dose calibrator 

12 falls outside the suggested tolerances. For example, a licensee shall repair or replace the dose 

13 calibrator if the accuracy or constancy error exceeds 10 percent and shall mathematically 

14 correct dosage readings [for dosages greater than 1.11 megabecquerels (MBq) or 30 microcurie 

15 (μCi)] if the geometry or linearity error exceeds 10 percent. In addition, after repair, adjustment, 

16 or relocation to another building, the dose calibrator tests will be repeated before use. 

17 Constancy means reproducibility in measuring a constant source over a long period of time. At 

18 least one relatively long-lived source, such as cesium-137 (Cs-137), cobalt-60, cobalt-57 

19 (Co-57), or radium-226 will be assayed using reproducible geometry each day before using the 

20 calibrator. Two or more sources with different photon energies and activities will also be used. 

21 1. Assay each reference source using the appropriate dose calibrator setting (e.g., use the 

22 Cs-137 setting to assay Cs-137). 

23 2. Measure background at the same setting, and subtract or confirm the proper operation 

24 of the automatic background subtract circuit if it is used. 

25 3. For each source used, record (e.g., plot, log) the activity measured, the model and serial 

26 number of the instrument, the identity of the radionuclide contained in the check source, 

27 the date of the check, and the name of the individual who performed the test. 

28 4. Using one of the sources, repeat the above procedure for all commonly used 

29 radionuclide settings. Record (e.g., plot, log) the results. 

30 5. Notify the radiation safety officer (RSO) or the authorized user if the test results fall 

31 outside +/- 10% of the expected results. 

32 Linearity means that the calibrator is able to indicate the correct activity over the range of use 

33 of that calibrator. The linearity of a dose calibrator will be ascertained over the range of its use 

34 between the maximum activity administered and 1.1 MBq [30 μCi]. This test will be performed 

35 using a vial or syringe of technetium-99m (Tc-99m) whose activity is at least as large as the 

36 maximum activity normally assayed for administration. 
G–2 

1 Time Decay Method 

2 1. Assay the Tc-99m syringe or vial in the dose calibrator, and subtract background to 

3 obtain the next activity in millicuries. Record the date, time to the nearest minute, and 

4 net activity on the dose calibrator linearity test form. 

5 2. Repeat the assay at approximately 4-hour intervals during the workday. Continue on 

6 subsequent days until the assayed activity is less than 1.1 MBq [30 μCi]. For dose 

7 calibrators on which you select a range with a switch, select the range you would 

8 normally use for the measurement. 

9 3. Convert the time and date information you recorded to hours elapsed since the 

10 first assay. 

11 4. Record the measured activities, the calculated activities, the time elapsed between 

12 measurements, the model number and serial number of the dose calibrator, the date(s) 

13 of the test, and the name of the individual who performed the test. 

5. Notify the RSO, if the deviation is more than + 14 /- 10%. 

15 Shield Method 

16 “Sleeves” of various thicknesses are used to test for linearity. However, they must first be 

17 calibrated. The applicant should review the procedure for calibrating sleeves against the 

18 manufacturer’s instructions. Some sleeve manufacturer’s procedures indicate that various 

19 sleeves should be stacked to achieve a desired attenuation. The following procedure should be 

20 modified to allow for stacking of sleeves: 

21 1. Begin the linearity test as described in the decay method described above. After making 

22 the first assay, the sleeves can be calibrated as follows. Steps 2 through 4 below must 

23 be completed within 6 minutes (i.e., approximately 1 percent of decay of Tc-99m). 

24 2. Put the base and sleeve 1 in the dose calibrator with the vial. Record the sleeve number 

25 and indicated activity. 

26 3. Remove sleeve 1 and put in sleeve 2. Record the sleeve number and indicated activity. 

27 4. Continue for all sleeves. 

28 5. Complete the decay method linearity test Steps 2 through 5 above. 

29 6. From the data recorded in step 4 of the decay method, find the decay time associated 

30 with the activity indicated with sleeve 1 in place. This is the “equivalent decay time” for 

31 sleeve 1. Record that time with the data recorded in step 2. 

32 7. Find the decay time associated with the activity indicated with sleeve 2 in place. This is 

33 the “equivalent decay time” for sleeve 2. Record that time with the data recorded in 

34 step 3. 

35 8. Continue for all sleeves. 
G–3 

1 9. The table of sleeve numbers and equivalent decay times constitutes the calibration of 

2 the sleeve set. 

3 The sleeve set may now be used to test dose calibrators for linearity. 

4 1. Assay the Tc-99m syringe or vial in the dose calibrator, and subtract background to 

5 obtain the net activity. Record the net activity. 

6 2. Steps 3 through 5 below must be completed within 6 minutes. 

7 3. Put the base and sleeve 1 in the dose calibrator with the vial. Record the sleeve number 

8 and indicated activity. 

9 4. Remove sleeve 1 and put in sleeve 2. Record the sleeve number and indicated activity. 

10 5. Continue for all sleeves. 

11 6. Record the measured activities, the calculated activities, the time elapsed between 

12 measurements, the model number and serial number of the dose calibrator, the date(s) 

13 of the test, and the name of the individual who performed the test. 

14 7. Notify the RSO if the worst deviation is more than +/- 10%. 

15 Geometry independence means that the indicated activity does not change with volume or 

16 configuration. The test for geometry independence will be conducted using syringes and vials 

17 that are representative of the entire range of size, shape, and constructions normally used for 

18 injections or administrations, and a vial similar in size, shape, and construction to the generator 

19 and radiopharmaceutical kit vials normally used. The following test assumes injections are 

20 done with 3 cubic centimeter (cc) plastic syringes and that radiopharmaceutical kits are made in 

21 30 cc glass vials and your predetermined safety margin is +/-10%. If 5 cc syringes, 10 cc glass 

22 vials, or any other geometric variations are used, the geometry testing will include these. 

23 Note: If these volumes are not used, change the procedure so that the syringes and vials are 

24 tested throughout the range of volumes commonly used. 

25 1. In a small beaker or vial, mix 2 cc of a solution of Tc-99m with an activity concentration 

26 between 1 and 10 millicuries (mCi)/milliliter. Set out a second small beaker or vial with 

27 water. 

28 2. To test the geometry dependence for a 3 cc syringe, draw 0.5 cc of the Tc-99m solution 

29 into the syringe and assay it. Record the volume and activity (e.g., mCi) indicated. 

30 3. Remove the syringe from the calibrator, draw an additional 0.5 cc of water and assay 

31 again. Record the volume and activity indicated. 

32 4. Repeat the process until you have assayed a 2.0 cc volume. 

33 5. Select as a standard the volume closest to that normally used for injections. For all the 

34 other volumes, divide the standard activity by the activity indicated for each volume. The 

35 quotient is a volume correction factor. Alternatively, graph the data and draw horizontal 

36 10% error lines above and below the chosen “standard volume.” 
G–4 

1 6. Record the model number and serial number of the dose calibrator, the configuration of 

2 the source measured, the activity measured for each volume measured, the date of the 

3 test, and the name of the individual who performed the test. 

4 7. Notify the RSO if any correction factors are greater than 1.1 or less than 0.9, or if any 

5 data points lie outside the +/- 10% error lines. 

6 8. To test the geometry dependence for a 30 cc glass vial, draw 1.0 cc of the Tc-99m 

7 solution into a syringe and then inject it into the vial. Assay the vial. Record the volume 

8 and activity indicated. 

9 9. Remove the vial from the calibrator and, using a clean syringe, inject 2.0 cc of water and 

10 assay again. Record the volume and activity indicated. 

11 10. Repeat the process until a 19.0 cc volume has been assayed. The entire process must 

12 be completed within 10 minutes. 

13 11. Select as a standard the volume closest to that normally used for mixing 

14 radiopharmaceutical kits. For all other volumes, divide the standard activity by the 

15 activity indicated for each volume. The quotient is a volume correction factor. 

16 Alternatively, graph the data and draw horizontal 10% error lines above and below the 

17 chosen “standard volume.” 

18 12. Record the model and serial number of the dose calibrator, the configuration of the 

19 source measured, the activity measured for each volume measured, the date of the test, 

20 and the name of the individual who performed the test. 

21 13. Notify the RSO if any correction factors are greater than 1.1 or less than 0.9, or if any 

22 data points lie outside the +/- 10% error lines. 

23 Accuracy means that, for a given calibrated reference source, the indicated activity (e.g., mCi) 

24 value is equal to the activity value determined by the National Institute of Standards and 

25 Technology (NIST) or by the supplier who has compared that source to a source that was 

26 calibrated by NIST. Certified sources are available from the NIST and from many radionuclide 

27 suppliers. At least one source with a principal photon energy between 100 kiloelectron-volts 

28 (keV) and 500 keV (e.g., Co-57 or barium-133) will be used. At least one reference source 

29 whose activity is within the range of activities normally assayed will be used. 

30 1. Assay a calibrated reference source at the appropriate settings (i.e., use the Co-57 

31 setting to assay Co-57), and then remove the source and measure background. 

32 Subtract background from the indicated activity to obtain the net activity. Record the net 

33 activity. 

34 2. The measurement should be within +/- 10% of the certified activity of the reference 

35 source, mathematically corrected for decay. 

36 3. Repeat the procedure for any other calibrated reference sources possessed. 

37 4. Record the model and serial number of the dose calibrator, the model and serial number 

38 of each source used, the identity of the radionuclide contained in the source and its 
G–5 

1 activity, the date of the test, the results of the test, and the name of the individual who 

2 performed the test. 

3 5. Notify the RSO if the test results do not agree, within +/- 10%, with the certified value of 

4 the reference source(s). 

5 6. At the same time the accuracy test is done, assay the source that will be used for the 

6 daily constancy test (it need not be a certified reference source) on all commonly used 

7 radionuclide settings. 

1 APPENDIX H 

2 MODEL PROCEDURES FOR REMOTE AFTERLOADER SPOT-CHECKS 

H–1 

1 Model Procedures for Remote Afterloader Spot-Checks 

2 This model provides acceptable procedures for performing spot-checks of Remote Afterloader 

3 units, equipment, and facilities. Applicants may either adopt these model procedures or develop 

4 alternative procedures. 

5 Periodic Spot-Checks for Remote Afterloader Units 

6 Before the first use on a given day (or before each patient treatment for low-dose-rate remote 

7 afterloaders) and after each source installation, the following spot-checks will be performed: 

8  Electrical Interlocks at Each Room Entrance 

9 Proper functioning of the treatment room door interlock will be performed using the remote 

10 afterloader source. 

11 Expose the remote afterloader source inside the treatment room, open the treatment room door, 

12 and verify that the source retracts. The source should retract immediately, the area radiation 

13 monitor should alarm, and the control console should indicate that the door is open. A physical 

14 survey of the unit will be performed to ensure that the source has fully retracted to the shielded 

15 safe prior to closing the door and clearing all alarms. 

16  Source Exposure Indicator Lights 

17 — Treatment Console Indicators and Status Lamps 

18 Turn on the remote afterloader unit and verify that the indicator lights flash to 

19 show proper function. In addition, when the source is exposed for the electrical 

20 interlock test above, verify that the source status indicator lights on the treatment 

21 console are lit to indicate an exposed source. 

22 — Remote Afterloader Indicators and Status Lamps 

23 Turn on the remote afterloader unit and verify that the indicator lights flash on the 

24 remote afterloader to show proper function. In addition, when the source is 

25 exposed for the electrical interlock test above, verify that the source status 

26 indicator lights on the remote afterloader are lit to indicate an exposed source. 

27  Viewing and Intercom Systems 

28 — Viewing System 

29 Turn on the camera(s). Check that the camera(s) is (are) operable and that the 

30 treatment area can be viewed from the treatment console. Adjust, if necessary. 

31 — Intercom System 

32 Turn on the intercom system. The intercom system will be tested using a 

33 two-person method. One person will be at the treatment console while another 

34 person is in the treatment room. Both individuals will speak and confirm that the 

35 other is heard. 
H–2 

1  Emergency Response Equipment 

2 Verify the presence of the emergency equipment within the treatment room. This 

3 equipment includes but is not limited to a mobile lead container large enough to hold the 

4 largest applicator, long-handled forceps, wire cutter, flashlight, suture removal kit, and 

5 timer (timer located at unit console). If a portable radiation survey meter is included, 

6 verify the presence of the meter and check the operability using a radioactive check 

7 source. 

8  Radiation Monitors Used to Indicate the Source Position 

9 Verify that the area radiation monitor located inside the treatment room is on with the 

10 indicator light flashing green. Expose the remote afterloader source inside the treatment 

11 room with the door closed and verify that the indicator light flashes red; indicating the 

12 presence of radiation. This test will be performed with the area radiation monitor on A/C 

13 power and on battery backup power. 

14  Timer Accuracy 

15 Expose the remote afterloader source inside the treatment room with the door closed. 

16 Immediately start a stopwatch when the control console indicates that the source is 

17 exposed. Stop the stopwatch when the control console indicates that the source is 

18 retracted. Compare the stopwatch measured time to the irradiation time indicated on the 

19 control console. Verify that the comparison is within 1 percent. 

20  Clock Date and Time in the Remote Afterloader’s Computer 

21 Verify clock date and time printed on the control console documentation of the 

22 pretreatment checks against the actual date and time. The date must be exact and the 

23 time may be within 1 hour. 

24  Decayed Source Activity in the Remote Afterloader’s Computer 

25 Verify the source activity (or decay factor) displayed on the remote afterloader control 

26 console matches to within 0.5 percent of the manufacturer’s provided decay table for 

27 today’s date. 

28 If the results of the above checks indicate the malfunction of any system, the control 

29 console shall be locked in the off position, as required by Title 10 of the Code of Federal 

30 Regulations (10 CFR) 35.643(e), and not used except as may be necessary to repair, 

31 replace, or check the malfunctioning system. 

32 In addition, consideration will be given to testing the following before the first use of the 

33 remote afterloader unit on a given day: 

34  Treatment Interrupt Button 

35 Press the “Interrupt” button on the control console while source is exposed. Verify that 

36 the source retracts immediately and the control console indicates an alarm. A physical 

37 survey of the unit will be performed to ensure that the source has fully retracted to the 

38 shielded safe prior to closing the door and clearing all alarms. 
H–3 

1  Emergency Off Button 

2 Press the “Stop” button on the control console while the source is exposed. Verify that 

3 the source retracts immediately and the control console indicates an alarm. Repeat the 

4 test for all wall-mounted “Stop” buttons. A physical survey of the unit will be performed 

5 to ensure that the source has fully retracted to the shielded safe prior to closing the door 

6 and clearing all alarms. 

7  Dual Use Switch 

8 An x-ray unit is also used in the remote afterloader treatment room, and a selector 

9 switch to limit operation to only one unit at a time is installed. 

10 With the key switch on the wall set to x-ray, attempt to expose the remote afterloader 

11 source. Verify that the area radiation monitor and the control console source indicator 

12 lights do not illuminate; indicating that the source did not expose. Switch the key to 

13 remote afterloader. Expose the remote afterloader source and confirm that the area 

14 radiation monitor illuminates. With the remote afterloader source still exposed, switch 

15 the key back to x-ray, and confirm that the remote afterloader source retracts and the 

16 area radiation monitor flashes green. A physical survey of the unit will be performed to 

17 ensure that the source has fully retracted to the shielded safe prior to closing the door 

18 and clearing all alarms. 

19  Misconnected or Missing Transfer Tube and/or Applicator 

20 Misconnect a transfer tube to the remote afterloader. This may either be performed by 

21 connecting the transfer tube to the wrong channel or by not fully inserting the transfer 

22 tube into the correct channel. Attempt to expose the remote afterloader source and 

23 verify that the source does not expose as indicated by the area radiation monitor. 

24 Additionally, verify that an error is indicated on the control console for the misconnection. 

25 Repeat the test with an applicator intentionally misconnected to a transfer tube that is 

26 correctly inserted into the remote afterloader. 

27  Mechanical Integrity of Applicators, Transfer Tubes, Connectors 

28 Perform a visual inspection of all applicators, transfer tubes, and connectors to be used 

29 for patient treatments that day. Check for any potential mechanical defects. Replace if 

30 a defect is noted. 

31  Position of Remote Afterloader Within the Treatment Room 

32 For some remote afterloader units located within minimally shielded rooms, the location 

33 of use within the room may have been specified in the application to ensure that the 

34 regulatory limits in 10 CFR 20.1301 will be met. If this is the case, verify that the 

35 positioning of the remote afterloader unit within the treatment room is in accordance with 

36 the commitments made in the application. 

1 APPENDIX I 

2 RADIATION SAFETY OFFICER DUTIES, RESPONSIBILITES, AND 

3 DELEGATION 

I–1 

1 Radiation Safety Officer Duties, Responsibilities, and Delegation 

2 Typical Duties and Responsibilities of the Radiation Safety Officer 

3 The radiation safety officer’s (RSO’s) duties and responsibilities include ensuring radiological 

4 safety and compliance with U.S. Nuclear Regulatory Commission (NRC) and U.S. Department 

5 of Transportation (DOT) regulations and the conditions of the license. Typically, these duties 

6 and responsibilities include ensuring the following: 

7  Stop activities involving licensed material that the radiation safety officer (RSO) 

8 considers unsafe. 

9  Ensure that radiation exposures are kept as low as is reasonably achievable (ALARA). 

10  Oversee all activities involving radioactive material, including monitoring and surveying 

11 all areas in which radioactive material is used. 

12  Ensure that up-to-date operating, emergency, and security procedures are developed, 

13 implemented, maintained, and distributed. 

14  Ensure that possession, use, and storage of licensed material are consistent with the 

15 limitations in the license, the regulations, the Sealed Source and Device (SSD) 

16 registration certificate(s), and the manufacturer’s recommendations and instructions. 

17  Ensure individuals installing, relocating, maintaining, adjusting, or repairing devices 

18 containing sealed sources are trained and authorized by an NRC or Agreement State 

19 license. 

20  Ensure personnel training is conducted and is commensurate with the individual’s duties 

21 regarding licensed material. 

22  Ensure documentation is maintained to demonstrate that individuals are not likely to 

23 receive, in one year, a radiation dose in excess of 10% of the allowable limits or that 

24 personnel monitoring devices are provided. 

25  When necessary, ensure personnel monitoring devices are used and exchanged at the 

26 proper intervals, and records of the results of such monitoring are maintained. 

27  Properly secure radioactive material. 

28  If the licensee possesses an aggregated Category 1 or Category 2 quantity of 

29 radioactive material, support development and implementation of a security program for 

30 radioactive material in accordance with 10 CFR 37. 

31  Ensure documentation is maintained to demonstrate, by measurement or calculation, 

32 that the total effective dose equivalent to the individual member of the public likely to 

33 receive the highest dose from the licensed operation does not exceed the annual limit in 

34 Title 10 of the Code of Federal Regulations (CFR) 10 CFR Part 20.1301, “Dose limits for 

35 individual members of the public.” 
I–2 

1  Notify proper authorities of incidents, such as damage to or malfunction of 

2 sources/devices, loss of licensed material, fire, theft, etc. 

3  Serve as a point of contact for the NRC’s and licensee’s management during routine 

4 operations, emergencies, or incidents. 

5  Medical events and precursor events are investigated and reported to the NRC, cause(s) 

6 and appropriate corrective action(s) are identified, and timely corrective action(s) are 

7 taken. 

8  Perform and document periodic audits, at least annually, of the radiation safety program 

9 to ensure that the licensee is complying with all applicable NRC regulations and the 

10 terms and conditions of the license. 

11  Ensure that the results of audits, identification of deficiencies, and recommendations for 

12 change are documented (and maintained for 3 years after the record is made) and 

13 provided to management for review; ensure that prompt action is taken to correct 

14 deficiencies. 

15  Ensure that the audit results and corrective actions are communicated to all personnel 

16 who use licensed material. 

17  When the licensee identifies violation(s) of regulations or license conditions or program 

18 weaknesses, ensure corrective action(s) are developed, implemented, and documented. 

19  Ensure that all incidents, accidents, and personnel exposure to radiation in excess of 10 

20 CFR Part 20 and 30 limits are investigated and reported to NRC and other appropriate 

21 authorities, if required, within the required time limits. 

22  Ensure licensed material is transported, or offered for transport, in accordance with all 

23 applicable NRC and DOT requirements. 

24  Ensure radioactive waste is disposed of in accordance with NRC regulations and license 

25 conditions. Supervise and coordinate the radioactive waste disposal program, including 

26 effluent monitoring and recordkeeping on waste storage and disposal records. Oversee 

27 the storage of radioactive material not in current use, including waste. 

28  Perform/oversee the inventory and leak testing on all sealed sources. 

29  Oversee the calibration of radiation survey instruments. 

30  Supervise decontamination operations. 

31  Maintain up-to-date copies of NRC regulations, the license, revised licensee procedures, 

32 and ensure that the license is amended whenever there are changes in licensed 

33 activities, responsible individuals, or information or commitments provided to the NRC 

34 during the licensing process. 

35  Submit amendment and renewal requests in a timely manner. 

 
I–3 

1 Model Delegation of Authority 

2 Memo To: (Name of Radiation Safety Officer) 

3 From: (Name of Chief Executive Officer or other ranking official) 

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 and radioactive material. You 

7 are responsible for managing the radiation protection program; identifying radiation protection 

8 problems; initiating, recommending, or providing corrective actions; verifying implementation of 

9 corrective actions; stopping unsafe activities; and ensuring compliance with regulations. You 

10 are hereby delegated the authority necessary to meet those responsibilities, including 

11 prohibiting the use of byproduct material by employees who do not meet the necessary 

12 requirements and shutting down operations when justified to maintain radiation safety. You are 

13 required to notify management if staff does not cooperate and does not address radiation safety 

14 issues. In addition, you are free to raise issues with the U.S. Nuclear Regulatory Commission at 

15 any time. It is estimated that you will spend _____ hours per week conducting radiation 

16 protection activities. 

17 ____________________________________ ____________________ 

18 Signature of Management Representative Date 

19 I accept the above responsibilities, 

20 _____________________________________ ____________________ 

21 Signature of Radiation Safety Officer Date 

22 cc: Names of affected department head

1 APPENDIX J 

2 MODEL TRAINING PROGRAM 

J–1 

1 Model Training Program 

2 Model procedures for describing training programs appear below. These models provide 

3 examples of topics to be chosen for training, based on the experience, duties, and previous 

4 training of trainees. The topics chosen will depend on the purpose of the training, the audience, 

5 and background knowledge of the audience. These models also may be useful to identify topics 

6 for annual refresher training. Refresher training should include topics with which the individual 

7 is not involved frequently and topics that require reaffirmation. Topics for refresher training 

8 need not include review of procedures or basic knowledge that the trainee routinely uses. 

9 Applicants may either adopt these model procedures or develop an alternative program to meet 

10 U.S. Nuclear Regulatory Commission (NRC) requirements. Guidance on requirements for 

11 training and experience for authorized medical physicists (AMP) and authorized users (AU) for 

12 medical use who engage in certain specialized practices is also included. 

13 Model Training Program for Medical and Non-medical Uses of Radionuclides, 

14 Sealed Sources, and Medical Devices Containing Sealed Sources 

15 Personnel will receive instruction before assuming duties with, or in the vicinity of, radioactive 

16 materials, during annual refresher training, and whenever there is a significant change in duties, 

17 regulations, terms of the license, or type of radioactive material or therapy device used. 

18 Records of worker training will be maintained for 3 years. The training records will include the 

19 date of the instruction or training, a brief outline of subjects covered, and the name(s) of the 

20 attendee(s) and instructor(s). 

21 Training for Individuals Involved in the Medical Use of Byproduct Material 

22 Training for professional staff [e.g., AU, AMP, authorized nuclear pharmacist, radiation safety 

23 officer (RSO), nurse, dosimetrist, technologist, therapist] may contain the following elements for 

24 those who provide or are involved in the care of patients during diagnostic or therapeutic 

25 procedures, commensurate with their duties: 

26  Basic radiation biology (e.g., interaction of ionizing radiation with cells and tissues). 

27  Basic radiation protection to include concepts of time, distance, and shielding. 

28  Concept of maintaining exposure as low as is reasonably achievable. (10 CFR 20.1101) 

29  Risk estimates, including comparison with other health risks. 

30  Posting requirements. (10 CFR 20.1902) 

31  Proper use of personnel dosimetry (when applicable). 

32  Access control procedures. (10 CFR 20.1601, 10 CFR 20.1802) 

33  Proper use of radiation shielding, if used. 

34  Patient release procedures (10 CFR 35.75) 
J–2 

1  Instruction in procedures for notification of the RSO and AU, when responding to patient 

2 emergencies or death, to ensure that radiation protection issues are identified and 

3 addressed in a timely manner. The intent of these procedures should in no way interfere 

4 with or be in lieu of appropriate patient care. (10 CFR 19.12, 10 CFR 35.310, 

5 10 CFR 35.410, 10 CFR 35.610) 

6  Occupational dose limits and their significance. (10 CFR 20.1201) 

7  Dose limits to the embryo/fetus, including instruction on declaration of pregnancy. 

8 (10 CFR 20.1208) 

9  Worker’s right to be informed of occupational radiation exposure. (10 CFR 19.13) 

10  Each individual’s obligation to report unsafe conditions to the RSO. (10 CFR 19.12) 

11  Applicable regulations, license conditions, information notices, bulletins, etc. 

12 (10 CFR 19.12) 

13  Where copies of the applicable regulations, the NRC license, and its application are 

14 posted or made available for examination. (10 CFR 19.11) 

15  Proper recordkeeping required by NRC regulations. (10 CFR 19.12) 

16  Appropriate surveys to be conducted. (10 CFR 20.1501) 

17  Proper calibration of required survey instruments. (10 CFR 20.1501) 

18  Emergency procedures. 

19  Decontamination and release of facilities and equipment. (10 CFR 20.1406, 

20 10 CFR 30.36) 

21  Dose to individual members of the public. (10 CFR 20.1301) 

22  Licensee’s operating procedures (e.g., survey requirements, instrument calibration, 

23 waste management, sealed-source leak testing). (10 CFR 35.27) 

24  Hazardous Materials (HAZMAT) training for preparing shipments of radioactive material. 

25 (49 CFR Part 172) 

26 Training for Individuals Involved in Nonmedical Use of Byproduct Material 

27 Training for staff working with byproduct material for nonmedical uses or animals containing 

28 byproduct material may include, as appropriate, the elements that are listed above for medical 

29 uses. All training should be commensurate with the individual’s duties. 

30 Training for the Staff Directly Involved in Administration to or Care of Patients Administered 

31 Byproduct Material for which a Written Directive Is Required (Including Greater-than-30 

32 microcuries of I-131), or Therapeutic Treatment Planning 
J–3 

1 In addition to the topics identified above, the following topics may be included in instruction for 

2 staff involved in the therapy treatment of patients (e.g., nursing, RSO, AMP, AU, and 

3 dosimetrist), commensurate with their duties: 

4  leak testing of sealed sources (10 CFR 35.67) 

5  emergency procedures (including emergency response drills) (10 CFR 35.310, 

6 10 CFR 35.410, 10 CFR 35.610) 

7  operating instructions (10 CFR 35.27, 10 CFR 35.610) 

8  computerized treatment planning system (10 CFR 35.657) 

9  dosimetry protocol (10 CFR 35.630) 

10  detailed pretreatment quality assurance checks (10 CFR 35.27, 10 CFR 35.610) 

11  safe handling (when applicable) of the patient’s dishes, linens, excretions (saliva, urine, 

12 feces), and surgical dressings that are potentially contaminated or that may contain 

13 radioactive sources (10 CFR 35.310, 10 CFR 35.410) 

14  patient control procedures (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610) 

15  visitor control procedures, such as visitors’ stay times and safe lines in radiation control 

16 areas (patient’s room) (10 CFR 35.310, 10 CFR 35.410, 10 CFR 35.610) 

17  licensee’s WD Procedures, to ensure that each administration is in accordance with the 

18 WD, patient identity is verified, and where applicable, attention is paid to correct 

19 positioning of sources and applicators to ensure that treatment is to the correct site (or, 

20 for gamma stereotactic radiosurgery (GSR), correct positioning of the helmet) (10 CFR 

21 35.40, 10 CFR 35.41) 

22  proper use of safety devices and shielding to include safe handling and shielding of 

23 dislodged sources (or, in the case of remote afterloaders, disconnected sources) 

24 (10 CFR 35.410, 10 CFR 35.610) 

25  size and appearance of different types of sources and applicators (10 CFR 35.410, 

26 10 CFR 35.610) 

27  previous incidents, events, and/or accidents 

28  for remote afterloaders, teletherapy units, and GSR units, initial training provided by the 

29 device manufacturer or by individuals certified by the device manufacturer that is device 

30 model-specific and includes 

31 — design, use, and function of the device, including safety systems and 

32 interpretation of various error codes and conditions, displays, indicators, and 

33 alarms 
J–4 

1 — hands-on training in actual operation of the device under the direct supervision of 

2 an experienced user, including “dry runs” (using dummy sources) of routine 

3 patient set-up and treatment and implementation of the licensee’s emergency 

4 procedures 

5 — a method, such as practical examinations, to determine each trainee’s 

6 competency to use the device for each type of proposed use 

7 Additional Training for Authorized Medical Physicists 

8 Applicants for licenses to include AMPs who plan to engage in certain tasks requiring special 

9 training should ensure that the AMP is trained in the activities specific to the different types of 

10 uses listed in Title 10 of the Code of Federal Regulations (10 CFR) 35.51(b)(1). Note, for 

11 example, that additional training is necessary for AMP planning tasks such as remote 

12 afterloader therapy, teletherapy, GSR therapy, the use of the treatment planning system that 

13 applicants contemplate using, as well as the calculation of activity of strontium-90sources used 

14 for ophthalmic treatments (10 CFR 35.433). Medical physicists must also have training for the 

15 type(s) of use for which authorization is sought that includes hands-on device operation, safety 

16 procedures, clinical use, and the operation of a treatment planning system, as required in 

17 10 CFR 35.51(c). 

18 Additional Training for Authorized Users for Medical Uses of Byproduct Materials 

19 for Which a Written Directive Is Required 

20 Applicants for licenses should carefully consider the type of radiation therapy that is 

21 contemplated. In addition to the training and experience requirements of 10 CFR 35.390, 

22 10 CFR 35.394, 10 CFR 35.396, 10 CFR 35.490, 10 CFR 35.491, and 10 CFR 35.690, attention 

23 should be focused on the additional training and experience necessary for treatment planning 

24 and quality control systems, and clinical procedures. Refer to the training and experience 

25 requirements associated with specialized uses discussed in 10 CFR 35.390, 35.490, 35.491, 

26 and 35.690. 

27 Training for Ancillary Staff 

28 For the purposes of this section, ancillary staff includes personnel engaged in janitorial and/or 

29 housekeeping duties, dietary, laboratory, security, and life-safety services. The training 

30 program for ancillary staff performing duties that are likely to result in a dose in excess of 

31 1 millisievert [100 millirem] will include instruction commensurate with potential radiological 

32 health protection problems present in the work place. Alternatively, prohibitions on entry into 

33 controlled or restricted areas may be applied to ancillary personnel unless escorted by trained 

34 personnel. 

35 Topics of instruction may include the following: 

36  storage, transfer, or use of radiation and/or radioactive material (10 CFR 19.12) 

37  potential biological effects associated with exposure to radiation and/or radioactive 

38 material, precautions or procedures to minimize exposure, and the purposes and 

39 functions of protective devices (e.g., basic radiation protection concepts of time, 

40 distance, and shielding) (10 CFR 19.12) 
J–5 

1  the applicable provisions of NRC regulations and licenses for the protection of personnel 

2 from exposure to radiation and/or radioactive material (e.g., posting and labeling of 

3 radioactive material) (10 CFR 19.12) 

4  responsibility to report promptly to the licensee any condition that may lead to or cause a 

5 violation of NRC regulations and licenses or unnecessary exposure to radiation and/or 

6 radioactive material (e.g., notification of the RSO regarding radiation protection issues) 

7 (10 CFR 19.12) 

8  appropriate response to warnings made in the event of any unusual occurrence or 

9 malfunction that may involve exposure to radiation and/or radioactive material 

10 (10 CFR 19.12) 

11  radiation exposure reports that workers may request, as per 10 CFR 19.13, 

12 “Notifications and reports to individuals” (10 CFR 19.12) 

13 References and Resources: 

14  National Council on Radiation Protection and Measurements (NCRP) Report No. 105, 

15 “Radiation Protection for Medical and Allied Health Personnel,” 1989. 

16  NCRP Report No. 134, “Operational Radiation Safety Training,” October 2000. 

17  International Commission on Radiological Protection (ICRP) Report No. 75, “General 

18 Principles for the Radiation Protection of Workers,” 1997. 

1 APPENDIX K 

2 GENERAL RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND 

3 SURVEY INSTRUMENT CALIBRATION PROGRAM 

K–1 

1 General Radiation Monitoring Instrument Specifications and Survey 

2 Instrument Calibration Program 

3 The following provides acceptable guidelines for radiation survey instrument calibrations. 

4 Licensees may either adopt these guidelines or develop their own to meet the requirements of 

5 Title 10 of the Code of Federal Regulations (10 CFR) Part 20 and 10 CFR 35.61. 

6 Radiation Monitoring Instrument Specifications 

7 The specifications in Table K–1 may help applicants and licensees choose the proper radiation 

8 detection equipment for monitoring the radiological conditions at their facility(ies). Except where 

9 indicated by an asterisk below, the information in Table K–1 was extracted from “The Health 

10 Physics and Radiological Health Handbook,” Revised Edition, 1992. 

Table K–1. Typical Survey Instruments 

Portable Instruments Used for Contamination and Ambient Radiation Surveys

Detectors Radiation Energy Range Efficiency

Exposure Rate Meters Gamma, X-ray milliroentgen 

(mR)-roentgen (R) 

N/A 

Count Rate Meters 

Geiger-Mueller (GM) Alpha All energies (dependent 

on window thickness) 

Moderate 

 Beta All energies (dependent 

on window thickness) 

Moderate 

 Gamma All energies < 1% 

NaI Scintillator Gamma All energies (dependent 

on crystal thickness) 

Moderate 

Plastic Scintillator Beta C-14 or higher (dependent 

on window thickness) 

Moderate 

Stationary Instruments Used to Measure Wipe, Bioassay, and Effluent Samples 

Detectors Radiation Energy Range Efficiency 

Liquid Scintillation Counter* Alpha All energies High

 Beta All energies High 

 Gamma Moderate 

Gamma Counter [sodium 

iodide (NaI)]* 

Gamma All energies High 

Gas Proportional Alpha All energies High 

 Beta All energies Moderate 

 Gamma All energies < 1% 

11 Equipment Selection 

12 Low-energy beta emitters, such as carbon-14 and sulfur-35, are difficult to detect with 

13 Geiger-Mueller (GM) probes. The detection efficiency generally is about 2% for low-energy beta 

14 emitters. The proper surveying method (e.g., speed and height above surface) is important to 

15 perform adequate surveys. Additionally, wipes should be taken and counted on a liquid 

16 scintillation counter to verify potential contamination. 
K–2 

1 Medium- to high-energy beta emitters, such as phosphorus-32 and calcium-45, can be detected 

2 with a pancake GM. The efficiency ranges from 15% to 40%, depending on the beta energy. 

3 Low-energy gamma emitters, such as iodine-125, can be detected with a sodium iodide (NaI) 

4 probe or a thin window GM probe (pancake or thin end-window). If the NaI probe possesses a 

5 thin window and thin crystal, the detection efficiency is approximately 20%. If a pancake or thin 

6 end-window GM probe is used, the detection efficiency is significantly lower, and care should be 

7 taken to ensure that the GM probe is capable of detecting the trigger levels. 

8 Medium- to high-energy gamma emitters, such as iodine-131 (I-131), can be detected with 

9 either GM or NaI probes, depending on the required sensitivity. In general, the sensitivity of GM 

10 probes is much lower than for NaI probes. 

11 Model Radiation Survey Instrument Calibration Program 

12 Training 

13 Before independently calibrating radiation survey instruments, an individual shall have 

14 sufficient training and experience to perform independent radiation survey instrument 

15 calibrations in accordance with 10 CFR 35.61. 

16  Classroom training may be in the form of lecture, video, computer-based, or self-study 

17 and will cover the following subject areas: 

18 — principles and practices of radiation protection 

19 — radioactivity measurements, monitoring techniques, and the use of radiation 

20 detection instruments 

21 — mathematics related to the use and measurement of radioactivity 

22 — biological effects of radiation 

23  On-the-job training will be considered complete if the individual has completed both of 

24 the following: 

25 — observing authorized personnel performing radiation survey instrument 

26 calibration 

27 — conducting radiation survey meter calibrations under the supervision and in the 

28 physical presence of an individual authorized to perform calibrations 

29 Facilities and Equipment 

30 To reduce doses received by individuals not calibrating radiation survey instruments, 

31 calibrations will be conducted in an isolated area of the facility or at times when no one else is 

32 present. 

33 The calibration source used for calibrating dose and dose rate measuring instruments should be 

34 well-collimated, and the calibration area should be designed to minimize scatter of radiation, 

35 which could affect the calibration process. 
K–3 

1 The calibration area should be appropriately controlled so that persons entering the area will be 

2 aware if a radiation source is in use. Evaluate posting of the calibration area with appropriate 

3 radiation warning signs, as required by Subpart J of 10 CFR 20. 

4 Individuals conducting radiation survey instrument calibrations will wear assigned dosimetry. 

5 Individuals conducting calibrations will use a calibrated and operable radiation survey 

6 instrument to ensure that unexpected changes in exposure rates are identified and corrected. 

7 Frequency of Calibration of Radiation Measurement Instruments 

8 A licensee committed to a routine or emergency radiation survey program should perform an 

9 acceptable calibration of all radiation measurement instruments and equipment at the frequency 

10 specified in U.S. Nuclear Regulatory Commission (NRC) regulations, annually, or at the 

11 frequency recommended by the manufacturer, whichever period is shorter. 

12 Special calibrations should be performed at any time there is reason to believe that the 

13 operating characteristics of a radiation measurement instrument have changed, by repair or 

14 alteration, or whenever system performance is observed to change significantly. (Battery 

15 changes are not considered as a repair or alteration.) 

16 Routine maintenance of radiation measurement instruments should be performed as 

17 recommended by the manufacturer. 

18 Primary or secondary standard instruments used to calibrate radiation measurement 

19 instruments should be inspected frequently for consistency of performance. 

20 Calibration Sources for Dose and Dose Rate Measuring Instruments

21 Radiation survey instruments will be calibrated with a radioactive source, in accordance with 

22 10 CFR 35.61. Electronic calibrations alone are not acceptable. A radioactive sealed source(s) 

23 will be used for calibrating dose and dose rate measuring radiation survey instruments, and this 

24 source will have the following characteristics: 

25  The source should approximate a point source. 

26  Calibration fields from gamma sources should be known with an accuracy when 

27 compared to secondary or primary national standards of 5 percent for dose rates greater 

28 than or equal to 1.0 microGray/hour (μGy)/h [0.1 millirad (mrad)/h] and 10 percent for 

29 dose rates less than 1.0 μGy/h [0.1 mrad/h]. 

30  The source should contain a radionuclide that emits radiation of identical or similar type 

31 and energy [e.g., cesium-137 (Cs-137), cobalt-60) as the environment in which the 

32 calibrated device will be used. 

33  Provides a radiation dose rate sufficient to reach the full scale (less than 1,000 mR/h) of 

34 the instrument calibrated. 
K–4 

1  The source should be strong enough to give an exposure rate of at least 

2 7.7 microcoulomb per kilogram per hour [30 milliroentgen per hour] at 100 centimeters 

3 [e.g., 3.1 gigabecquerels (85 millicuries) of Cs-137 or 780 megabecquerels 

4 (21 millicuries) of cobalt-60]. 

5 Note: Inverse square and radioactive decay laws should be used to correct for changes in 

6 exposure rate due to changes in distance or source decay. Instrument readings should be 

7 within ± 10% of known radiation values at calibration points; however, readings within ± 20% are 

8 acceptable if a calibration chart or graph is prepared and made available with the instrument. 

9 Calibration of Dose or Dose Rate Measuring Instruments 

10 There are three kinds of scales frequently used on dose or dose-rate survey meters. These are 

11 calibrated as follows: 

12  Linear readout instruments with a single calibration control for all scales should be 

13 adjusted at the point recommended by the manufacturer or at a point within the normal 

14 range of use. Instruments with calibration controls for each scale should be adjusted on 

15 each scale. After adjustment, check the response of the instrument at approximately 20 

16 percent and 80 percent of full scale. Instrument readings shall be within ± x of the 

17 conventionally true value for the following ranges: 

18 — Background to 10 μGy/h [1.0 mrad/h]; ±x = ±30% 

19 — 10 μGy/h [1.0 mrad/h] to 1.0 milliGray (mGy)/h [100 mrad/h]; ±x = ±20% 

20 — 1.0 mGy/h [100 mrad/h] to 10 gray/h [1,000 Rad/h]; ±x = ±10% 

21  Logarithmic readout instruments, which commonly have a single readout scale 

22 spanning several decades, normally have two or more adjustments. Adjust the 

23 instrument for each scale according to site specifications or the manufacturer’s 

24 specifications. After adjustment, check the calibration at a minimum of one point on 

25 each decade. Instrument readings should have a maximum deviation from the 

26 conventionally true value as described for linear readout instruments. 

27  Digital readout instruments should be calibrated the same as linear 

28 readout instruments. Digital readout instruments without scale switching for indicating 

29 exposure rates shall be checked at two points on each decade. 

30  Integrating instruments shall be checked at two dose rates at approximately 20% and 

31 80% of the stated dose rate range. Instrument readings shall be within the same ± x of 

32 the conventionally true value as described for linear readout instruments. 

Note: Readings above 2.58 × 10-4 33 coulomb/kilogram/hour [1R/h] need not be calibrated, unless 

34 the licensee expects to make measurements at higher dose rates; regardless, such scales may 

35 be checked for operation and response to radiation. 

36 Note: Instruments used to monitor higher energies are most easily calibrated in known 

37 radiation fields produced by sources of gamma rays of approximately the same energies as 

38 those to be measured. 
K–5 

1 Calibration of Surface Contamination Measurement Instruments 

2 Instruments used to detect surface contamination usually consist of a count-rate meter and a 

3 detector that is appropriate for the type of radiation(s) being measured. 

4 The efficiency of radiation survey meters must be determined by using radiation sources with 

5 similar energies and types of radiation that users of the radiation survey instrument intend to 

6 measure. 

7 If each scale has a calibration potentiometer, the reading should be adjusted to respond to the 

8 calibration source at approximately 80 percent of full scale, and the response at approximately 

9 20 percent of full scale should be observed. If only one calibration potentiometer is available, 

10 the response should be adjusted at mid-scale on one of the scales, and response on the other 

11 scales should be observed. The instrument efficiency factor [e.g., counts per minute 

12 (cpm)/disintegrations per minute (dpm)] thus obtained should have a signal-to-noise ratio, 

13 including the compilation of source and instrument uncertainties, of ±x for the following ranges: 

14  alpha measurement

0.01 becquerel (Bq)/square centimeter (cm2

) to 2.0 Bq/cm2 [60 to 12,000 dpm/100 cm2 15 ]; 

16 ±x = ±20% 

 2.0 Bq/cm2

 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2 17 ]; ±x = ±10% 

18  beta measurement

0.05 Bq/cm2

 to 2.0 Bq/cm2 [300 to 12,000 dpm/100 cm2 19 ]; ±x = ±20% 

2.0 Bq/cm2

 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2 20 ]; ±x = ±10% 

21 Calibration of Analytical Instruments Such As Liquid Scintillation Counters, 

22 Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers 

23 

24 Analytical instruments used to determine radioactivity in a sample may be specialized 

25 equipment according to the type of samples to be analyzed and the types and quantities of 

26 radioactivity to be measured. Typically, the sample sizes and activities are very small, and can 

27 be difficult to measure. Sample collection and preparation may differ for the various analytical 

28 instruments, so manufacturer procedures and industry standard practices should be followed. 

29 Such analytical instruments should be calibrated in accordance with the manufacturer’s 

30 instructions. Analytical instruments typically require routine maintenance and verification 

31 procedures to ensure that they are operating properly when used. 

32 As with calibration of other radiation measurement instruments, calibration of analytical 

33 instruments use a radioactive sealed source(s). These should be suitable for the geometry of 

34 the sample(s) to be analyzed. The calibration source(s) should have a known activity(ies) and 

35 be of similar type and energy as the radioactive materials to be analyzed. The analysis should 

36 be sensitive enough to detect the lowest levels of radioactivity desired. Correction of results for 

37 quenching, self-absorption, and other factors may be required, depending on the analytical 

38 instrument, the samples type, and other environmental conditions. 

39 Calibration Records 

40 A record must be made of each radiation survey instrument calibration and retained for 3 years 

41 after each record is made (10 CFR 20.2103(a) and 10 CFR 35.2061). 
K–6 

1 Calibration records for all radiation survey instruments should indicate the procedure used and 

2 the results of the calibration. The records should include the following: 

3  the owner or user of the radiation survey instrument 

4  a description of the radiation survey instrument that includes the manufacturer’s name, 

5 model number, serial number, and type of detector 

6  a description of the NIST-traceable calibration source, including the calibration 

7 procedure, exposure rate, distance at which it was measured, and date of measurement 

8  for each calibration point, the calculated exposure rate or count rate, the indicated 

9 exposure rate or count rate, the deduced correction factor (the calculated exposure rate 

10 or count rate divided by the indicated exposure rate or count rate), and the scale 

11 selected on the radiation survey instrument 

12  the efficiency of the radiation survey instrument for each radionuclide the instrument will 

13 be used to measure, if efficiency is not calculated before each use 

14  the exposure reading indicated with the radiation survey instrument in the “battery 

15 check” mode, if available on the instrument 

16  for radiation survey instruments with external detectors, the angle between the radiation 

17 flux field and the detector (i.e., parallel or perpendicular) 

18  for radiation survey instruments with internal detectors, the angle between the radiation 

19 flux field and a specified surface of the instrument 

20  for radiation detectors with removable shielding, an indication of whether the shielding 

21 was in place or removed during the calibration procedure 

22  the exposure rate from a check source, if used 

23  the name of the person who performed the calibration and the date it was performed 

24 The following information will be attached to the radiation survey instrument as a calibration 

25 sticker or tag: 

26  for dose and dose rate measuring instruments, the source radionuclide that was used to 

27 calibrate the instrument (with correction factors) for each scale 

28  the proper deflection in the battery check mode, unless this is clearly indicated on the 

29 instrument 

30  special use conditions (e.g., an indication that a scale or decade was checked only for 

31 function but not calibrated) 

32  for each scale or decade not calibrated, an indication that the scale or decade was 

33 checked only for function but not calibrated 

34  the date of calibration and the next calibration due date 
K–7 

1  the apparent exposure rate or count rate from the check source, if used 

2  sensitivity of counting system 

3 Follow the procedures in Appendix Q of this NUREG to determine minimum detectable activity 

4 (MDA) if there is a question concerning the ability to measure small quantities of radioactivity. 

5 Calculating the Efficiency of Sodium Iodide (Thallium Doped) Uptake Probes 

6 Sodium iodide (thallium doped) uptake probes are commonly used for bioassays of personnel 

7 administering I-131 radionuclides in the form of liquid NaI. Refer to 10 CFR Part 20, 

8 Appendix B, “Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of 

9 Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release 

10 to Sewerage” for the ALIs and DACs for occupational exposure to radionuclides. Convert count 

11 rates (e.g., in cpm) to units of activity (dpm, μCi) when performing bioassays to determine 

12 thyroid burdens of radioiodine. 

13 Use the following procedure to calibrate the probe for uptake measurements: 

14  Check the instrument’s counting efficiency using either a standard source of the same 

15 radionuclide as the source being tested or one with similar energy characteristics. 

16 Accuracy of standards will be within ± 5% of the stated value and traceable to a primary 

17 radiation standard such as those maintained by NIST. 

18  Calculate the efficiency of the instrument. 

19 For example: 

	 ൌ௔ ݂݂ܧ

ሻሿܾ݇݃	݉݋ݎ݂	݉݌ܿሺ െ ሻ݀ݐݏ	݉݋ݎ݂	݉݌ܿሾሺ

ሻݏ݅݁ݎݑܿ݋ݎ݉݅ܿ	݅݊	݀ݐݏ	݂݋	ݕݐ݅ݒ݅ݐܽܿሺ

where: Effa = efficiency1 20 , 

21 cpm = counts per minute, 

22 std = standard, and 

23 bkg = background. 

24 Operational and calibration checks, using a dedicated check source, should be conducted each 

25 day the instrument is used. 

26 The date of the efficiency test should be attached to the instrument as a calibration sticker or 

27 tag, and the following information should be included: 

28  the due date of the next efficiency test 

29  results of efficiency calculation(s) 

 

1

The absolute efficiency is dependent on the counting geometry. Applicants may elect to use the intrinsic efficiency, 

which no longer includes the solid angle subtended by the detector and is much less dependent on the counting 

geometry. 
K–8 

1 Calculating the Gamma Well Efficiency of Counting Equipment 

2 Gamma well counting equipment is often used for assaying the wipe testing of packages, 

3 sealed sources, and areas where unsealed byproduct material is prepared, administered, or 

4 stored. Converting cpm to dpm using smear wipes is required when dealing with radiation 

5 surveys of sealed and unsealed radioactive materials. Calculate the efficiency of all instruments 

6 used for assaying wipe tests on an annual basis, before first use, and/or after repair, using the 

7 following procedure: 

8  Check the instrument’s counting efficiency, using either a standard source of the same 

9 radionuclide as the source being tested or one with similar energy characteristics. 

10 Accuracy of standards will be within ± 5% of the stated value and traceable to a primary 

11 radiation standard such as those maintained by NIST. 

12  Calculate the efficiency of the instrument. 

13 For example:

ሻሿܾ݇݃	݉݋ݎ݂	݉݌ܿሺ െ ሻ݀ݐݏ	݉݋ݎ݂	݉݌ܿሾሺ 	ൌ ݂݂ܧ

		 ሻݏ݅݁ݎݑܿ݋ݎ݉݅ܿ	݅݊	݀ݐݏ	݂݋	ݕݐ݅ݒ݅ݐܽܿሺ

14 where: Eff = efficiency, in cpm/microcurie, 

15 cpm = counts per minute, 

16 std = standard, and 

17 bkg = background. 

18 Operational and calibration checks, using a dedicated check source, should be conducted each 

19 day the instrument is used. 

20 The date of the efficiency test should be attached to the instrument as a calibration sticker or tag 

21 and the following information should be included: 

22  the due date of the next efficiency test 

23  results of efficiency calculation(s) 

24 References: 

25  Detailed information about portable radiation survey instrument calibration may be 

26 obtained by referring to American National Standards Institute (ANSI) N323AB-2013, 

27 “American National Standard for Radiation Protection Instrumentation Test and 

28 Calibration, Portable Survey Instruments.” Copies may be obtained from the ANSI 

29 eStandards Store. 

30  National Council on Radiation Protection and Measurements (NCRP) Report No. 112, 

31 “Calibration of Survey Instruments Used in Radiation Protection for the Assessment of 

32 Ionizing Radiation Fields and Radioactive Surface Contamination,” 1991. 
1 APPENDIX L 

2 MODEL MEDICAL LICENSEE AUDIT 

L–1 

1 Model Medical Licensee Audit 

2 Annual Radiation Protection Medical Licensee Audit 

3 Note: All areas indicated in audit notes may not be applicable to every license and may not 

4 need to be addressed during each audit. For example, licensees do not need to address areas 

5 that do not apply to the licensee’s activities, and activities that have not occurred since the last 

6 audit need not be reviewed at the next audit. Also, the audit notes may not be complete for 

7 nonmedical uses authorized on the license. Licensees should review audit lists in other 

8 volumes of the NUREG–1556 series, as appropriate, when completing the audit list that is 

9 specific to nonmedical uses. 

10 Date of this audit: _________________ 

11 Date of last audit: _________________ 

12 Date of next audit: _________________ 

13 Auditor: 

14 _____________________________________________________________ 15 Signature Date 

16 Management review:

17 _____________________________________________________________ 18 Signature Date

19 All references are to Title 10 of the Code of Federal Regulations (CFR) Parts unless noted 

20 otherwise. 

21 License (License Condition) 

22 1. License Number. 

23 2. Current Amendment Number. 

24 3. Are all of the tie-down documents on file? 

25 4. Has the Legal Entity having control over licensed activities changed since the last audit? 

26 Are materials, uses, and locations of use confined to those specifically described in the 

27 license? 

28 Audit History 

29 1. Were previous audits conducted annually [20.1101(c)]? 

30 2. Were records of previous audits maintained [20.2102(b)]? 

31 3. Were any deficiencies identified during previous audit? 

32 4. Were corrective actions taken? (Look for repeated deficiencies.) 

5. Any previous problem/deficiency not corrected or repeated? 
L–2 

1 Organization and Scope of Program 

2 1. Radiation Safety Officer (RSO) 

3 a. If the RSO was changed, was the license amended [35.13(c)]? 

4 b. Does the new RSO meet U.S. Nuclear Regulatory Commission (NRC) training 

5 requirements [35.50, 35.57, 35.59]? 

6 c. If the scope of the program expanded, does the RSO have training in radiation 

7 safety, regulatory issues, and emergency procedures for the new uses 

8 [35.50(e)]? 

9 d. Is the RSO fulfilling all duties [35.24(e)]? 

10 e. If the scope of the program expanded, have the RSO duties been updated to 

11 reflect the scope of the program [35.24(e)]? 

12 f. Is the written agreement in place for the new RSO [35.24(b)]? 

13 g. Has NRC been notified about a temporary RSO [35.14(b)(2)]? 

14 h. Are the written agreements and duties and responsibilities in place for the 

15 temporary RSO [35.24(b), (c), (e), (g), and (h)]? 

16 2. Multiple places of use? If yes, list locations. (License Condition [L/C]) 

17 3. Are all locations listed on license? (L/C) 

18 4. Were annual audits performed at each location? If no, explain. 

19 5. Describe the scope of the program (staff size, number of procedures performed, etc.) 

20 6. Licensed Material: (L/C) 

21 a. Isotope, chemical form, physical form, quantity, and use as authorized? 

22 b. Does the total amount of radioactive material possessed require financial 

23 assurance [30.35(a)]? If so, is financial assurance current based on 

24 NUREG–1757, Volume 3 ? 

25 c. Calibration, transmission, and reference sources [35.65]? 

26 i. Sealed sources manufactured and distributed by a person licensed 

27 pursuant to 10 CFR 32.74, equivalent Agreement State regulations, or 

28 redistributed by a licensee authorized to redistribute sealed sources, and 

29 sources do not exceed 1.11 GBq [30 millicuries (mCi)] each [35.63(a) and 

30 (b)]? 

31 ii. Any byproduct material with a half-life not longer than 120 days in 

32 individual amounts not to exceed 0.56 GBq [15 mCi] [35.65(c)]? 
L–3 

1 iii. Any byproduct material with a half-life longer than 120 days in individual 

2 amounts not to exceed the smaller of 7.4 MBq [200 microcuries (μCi)] or 

3 1,000 times the quantities in Appendix B of Part 30 [35.65(d)]? 

4 iv. Technetium-99m (Tc-99m) in individual amounts as needed [35.65(e)]? 

5 d. Unsealed materials used under 10 CFR 35.100, 35.200, and 35.300 are: 

6 i. Obtained from a manufacturer or preparer licensed under 10 CFR 32.72? 

7 OR 

8 ii. Obtained from a producer of Positron Emission Tomography radioactive 

9 drugs under 10 CFR 30.32(j)? 

10 OR 

11 iii. Prepared by a physician authorized user (AU), an authorized nuclear 

12 pharmacist (ANP), or an individual under the supervision of an ANP or 

13 physician AU? 

14 OR 

15 iv. Obtained and prepared for research in accordance with 10 CFR 35.100, 

16 10 CFR 35.200, and 10 CFR 35.300, as applicable? 

17 7. Are the sealed sources possessed and used as described in the Sealed Source and 

18 Device Registry registration certificate in 10 CFR 32.210, 35.400, 35.500, 35.600? Are 

19 manufacturers’ manuals for operation and maintenance of medical devices possessed? 

20 8. Are the actual uses of medical devices consistent with the authorized uses listed on the 

21 license? (L/C) 

22 9. If places of use/storage changed, was the license amended [35.13(e)]? 

23 10. If control of the license was transferred or bankruptcy filed, was NRC’s prior consent 

24 obtained or notification made [30.34(b) and 30.34(h), respectively]? 

25 11. Is radioactive material regulated under 10 CFR 35.1000 used in accordance with the 

26 license conditions and tie-down commitments? (L/C) 

27 Radiation Safety Program 

28 1. Minor changes to program [10 CFR 35.26 or license condition for 10 CFR 35.1000 

29 medical uses]? 

30 2. Records of changes maintained for 5 years [35.2026(a)]? 

31 3. Content and implementation reviewed annually by the licensee [20.1101(c)]? 

32 4. Records of reviews maintained [20.2102(a)(2)]? 
L–4 

1 Nationally Tracked Sources 

2 1. Reports of transactions involving nationally tracked sources submitted to National 

3 Source Tracking System (10 CFR 20.2207)?

4 Use by Authorized Individuals (L/C) 

5 1. Authorized Nuclear Pharmacist [35.55, 35.57, 35.59]: 

6 a. Listed on a facility license? 

7 2. Authorized user [35.57, 35.59, and 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 

8 35.490, 35.491, 35.590, 35.690]: 

9 a. Listed on a facility license? 

10 b. Each AU only uses material for which they are authorized? 

11 3. Authorized medical physicist (AMP) [35.51, 35.57, 35.59]: 

12 a. Listed on a facility license? 

13 b. Each AMP only uses material for which they are authorized? 

14 4. Non-medical use authorized users [30.33(a)(3)]: 

15 a. Listed on facility license for same materials and uses? 

16 Mobile Medical Service 

17 1. Operates services per 35.80, 35.647? 

18 2. Compliance with public dose limits evaluated and met [20.1301, 20.1302]? 

19 3. Are all base locations listed on the license? (L/C) 

20 4. Mobile Medical Agreement letter signed by management of each client [35.80(a)]? 

21 5. Licensed material not delivered to client’s address, unless client was authorized 

22 [35.80(b)]? 

23 6. Dosage measuring instruments checked for proper function before use at each address 

24 of use or on each day of use, if more frequent [35.80(a)]? 

25 7. Survey instruments checked for proper operation before use at each address of use 

26 [35.80(a)]? 

27 8. Survey all areas of use prior to leaving each client address [35.80(a)]? 

28 9. Adequate security maintained for mobile trailer? Keypad codes changed or keys 

29 retrieved when an employee terminates employment [20.1801, 20.1802]? 
L–5 

1 10. AUs briefed on responsibilities for supervising the use of licensed material [35.27]? 

2 11. Compliance with additional technical requirements for mobile remote afterloaders 

3 evaluated and met [35.647]? 

4 Amendments Since Last Audit [35.13] 

5 1. Any Amendments since last audit [35.13]? 

6 2. Security-related sensitive information was properly marked [10 CFR 2.390]? 

7 Notifications Since Last Audit [35.14] 

8 1. Any Notifications since last audit [35.14]? 

9 2. Appropriate documentation provided to NRC for ANP, AMP, or AU, no later than 30 days 

10 after the individual starts work [35.14(a), 30.34(j)(4)]? 

11 3. NRC notified within 30 days after: AU, ANP, AMP, or RSO stops work or changes 

12 name; licensee’s mailing address changes; licensee’s name changes without a transfer 

13 of control of the license; or licensee has added to or changed an area of use for 

14 10 CFR 35.100 or 35.200 use [35.14]. 

15 Training, Retraining, and Instructions to Workers 

16 1. Is the training program implemented? Have workers been provided with required 

17 instructions [19.12, 35.27, 35.310, 35.410, 35.610]? 

18 2. Is the individual’s understanding of current procedures and regulations adequate? 

19 3. Do appropriate individuals have adequate understanding of appropriate: 

20 a. Operating procedures [35.27, 35.310, 35.410, 35.610]? 

21 b. Emergency procedures [35.27, 35.310, 35.410, 35.610]? 

22 4. Do appropriate individuals have an up-to-date copy of the licensee’s operating use and 

23 emergency procedures? 

24 5. Periodic training required and implemented [35.310, 35.410, 35.610]? 

25 6. Were all workers who are likely to exceed 1 millisievert (mSv) [100 millirem (mrem)] in a 

26 year instructed and was refresher training provided, as needed [19.12]? 

27 7. Was each supervised user instructed in the licensee’s written radiation protection 

28 procedures and administration of written directives (WD), as appropriate [35.27]? 

29 8. Are initial and periodic training records maintained for each individual [35.2310]? 

30 9. Briefly describe training program. 

31 10. Hazardous Materials (HAZMAT) training [49 CFR Part 172] 
L–6 

1 11. Do additional therapy device instructions/training include: 

2 a. Unit operation, inspection, associated equipment, survey instruments? 

3 b. License conditions applicable to the use of the unit? 

4 c. Emergency drills [35.610]? 

5 12. 10 CFR Part 20 – Are workers cognizant of requirements for: 

6 a. Radiation Safety Program [35.24, 35.26, 20.1101]? 

7 b. Annual dose limits [20.1201, 20.1301, 20.1302]? 

8 c. NRC Forms 4 and 5? 

9 d. 10% monitoring threshold [20.1502]? 

10 e. Dose limits to embryo/fetus and declared pregnant worker [20.1208]? 

11 f. “Grave Danger” Posting [20.1902(c)]? 

12 g. Procedures for opening packages [20.1906]? 

13 13. Is supervision of individuals by AU and/or ANP in accordance with 10 CFR 35.27? 

14 14. Was training provided for workers involved with emerging technologies in accordance 

15 with the NRC license and tie-downs? 

16 Training for Manual Brachytherapy and Use of Unsealed Byproduct Material for 

17 Which a Written Directive Is Required 

18 1. Does safety instruction to personnel include [35.310, 35.410]: 

19 a. Control of patient and visitors? 

20 b. Routine visitation to patients in accordance with 10 CFR 20.1301? 

21 c. Contamination control and size/appearance of sources? 

22 d. Safe handling and shielding instructions? 

23 e. Waste control? 

24 f. RSO and AU notification if patient had a medical emergency or died? 

25 g. Records retained [35.2310]? 

26 Facilities 

27 1. Facilities as described in license application? (L/C) 

28 2. Therapy device facilities provided with electrical interlock system, viewing and intercom 

29 systems, radiation monitor, source retraction mechanism, and source indicator lights? 

30 3. Emergency source recovery equipment available [35.415, 35.615]? 

31 4. Storage areas: 

32 a. Materials secured from unauthorized removal or access [20.1801]? 

33 b. Licensee controls and maintains constant surveillance of licensed material not in 

34 storage [20.1802]? 
L–7 

1 c. Locations appropriately shielded to control public and occupational exposures in 

2 accordance with 10 CFR Part 20? 

3 5. Therapy unit operation: 

4 a. Unit, console, console keys, and treatment room controlled adequately [20.1801, 

5 20.1802, 35.610(a)(1)]? 

6 b. Restricted to certain source orientations and/or gantry angles? (L/C) 

7 c. Ceases to operate in restricted orientation(s)? (L/C) 

8 d. Only one radiation device can be placed in operation at a time within the 

9 treatment room [35.610(a)(3)]? 

10 Dose or Dosage Measuring Equipment 

11 1. Possession, use, and calibration of instruments to measure activities of unsealed 

12 radionuclides [35.60]: 

13 a. Types of equipment listed? 

14 b. Approved procedures for use of instrumentation followed? 

15 c. Constancy, accuracy, linearity, and geometry dependence tests performed in 

16 accordance with nationally recognized standards or the manufacturer’s 

17 instructions? 

18 d. Instrument repaired or replaced or dosages mathematically corrected, as 

19 required, when tests do not meet the performance objectives provided in the 

20 nationally recognized standard or manufacturer’s instructions (e.g., ±10%)? 

21 e. Records maintained and include required information [35.2060]? 

22 2. Determination of dosages of unsealed byproduct material [35.63]? 

a. Each dosage determined and recorded prior to medical use [35.63(a)]1 23 ? 

24 b. Measurement of unit dosages of alpha-, beta-, or photon-emitting radionuclides 

25 made either by direct measurement [35.63(b)] or by decay correction of the 

26 activity provided by the licensed producer [32.72]? 

27 c. For other than unit dosages of alpha-, beta-, or photon-emitting radionuclides, 

28 measurement made by direct measurement of radioactivity [35.63(c)] or by 

29 combination of radioactivity or volumetric measurement and calculation using the 

30 activity provided by the licensed producer [32.72]? 

31 3. Licensee uses generators? 

 

1

See Sections 8.9.3 and 8.10.20 for additional information regarding Rb-82 generators. 
L–8 

1 a. First eluate after receipt tested for molybdenum-99 (Mo-99) breakthrough 

2 [35.204(b)]? 

3 b. No radiopharmaceuticals administered with Mo-99 concentrations over 0.15 kbq 

4 per Mbq [0.15 μCi per mCi] of Tc-99m [35.204(a)(1)]? 

5 c. First eluate after receipt tested for strontium-82 (Sr-82) and strontium-85 (Sr-85) 

6 when eluting rubidium-82 (Rb-82) [35.204(c)]? 

7 d. No radiopharmaceuticals administered with Sr-82 concentrations over 0.02 kbq 

8 per MBq [0.02 μCi per mCi] of Rb-82 or Sr-85 concentrations over 0.2 kbq per 

9 MBq [0.2 μCi per mCi] of Rb-82 [35.204(a)(2)]? 

10 e. Records maintained [35.2204]? 

11 4. Confirmation of source output or activity for manual brachytherapy sources? 

12 Alternatively, the manufacturer’s measurements may be accepted if the criteria in 

13 10 CFR 35.432(b) have been met. 

14 5. Dosimetry Equipment [35.630]: 

15 a. Calibrated system available for use [35.630(a)]? 

16 b. Calibrated by National Institute of Standards and Technology or an American 

17 Association of Physicists in Medicine (AAPM)-accredited lab within previous 2 

18 years and after servicing [35.630(a)(1)] OR calibrated by intercomparison per 

19 10 CFR 35.630(a)(2)? 

20 c. Calibrated within the previous 4 years [35.630(a)(2)]? 

21 d. Licensee has available for use a dosimetry system for spot-check measurements 

22 [35.630(b)]? 

23 e. Record of each calibration, intercomparison, and comparison maintained 

24 [35.2630]? 

25 Radiation Protection and Control of Radioactive Material 

26 1. Use of radiopharmaceuticals: 

27 a. Protective clothing worn? 

28 b. Personnel routinely monitor their hands? 

29 c. No eating/drinking in use/storage areas? 

30 d. No food, drink, or personal effects kept in use/storage areas? 

31 e. Proper dosimetry worn? 

32 f. Radioactive waste disposed of in proper receptacles? 

33 g. Syringe shields and vial shields used and are specific to the energy emitted? 

34 h. Proper use of remote handling tools and radiation shields? 
L–9 

1 2. Leak tests and inventories: 

2 a. Leak test performed on sealed sources and brachytherapy sources at 

3 appropriate intervals [35.67(b)(1) or leak test license condition]? 

4 b. Inventory of sealed sources and brachytherapy sources performed semiannually 

5 [35.67(g)]? 

6 c. If applicable, transactions associated with nationally tracked sources entered into 

7 the National Source Tracking System, including annual reconciliation [10 CFR 

8 20.2207]? 

9 d. Records maintained [35.2067]? 

10 Radiation Survey Instruments 

11 1. Survey instruments used to show compliance with 10 CFR Part 20 and 

12 10 CFR 30.33(a)(2): 

13 a. Appropriate operable survey instruments possessed or available 

14 [10 CFR Part 20]? 

15 b. Calibrations [35.61(a) and (b)]: 

16 i. Before first use, annually, and after repairs? 

17 ii. Within 20% on each scale or decade of interest, as applicable? 

18 iii. Instrument sent to a licensed instrument service provider? 

19 iv. Copy of instrument service provider license on file? 

20 c. Records maintained [35.2061]? 

21 2. Radiation surveys performed in accordance with the licensee’s procedures and the 

22 regulatory requirements [20.1501, 35.70]? 

23 a. Daily in all areas where radiopharmaceuticals requiring a WD are prepared or 

24 administered (except patient rooms) [35.70]? 

25 b. Weekly in all areas where radiopharmaceuticals or wastes are stored? 

26 c. Weekly for wipes in all areas where radiopharmaceuticals are routinely prepared, 

27 administered, or stored? 

28 d. Trigger levels established? 

29 e. Corrective action taken and documented if trigger level exceeded? 

30 f. Techniques can detect 0.1 milliroentgen/hour, 2,000 disintegrations per minute? 

31 g. Surveys made to assure that the maximum radiation levels and average radiation 

32 levels from the surface of the main source safe with the sources(s) in the 

33 shielded position do not exceed the levels stated in the Sealed Source and 

34 Device Registry [35.652(a)] and records maintained [35.2652]? 
L–10 

1 i. After new source installation? 

2 ii. Following repairs to the source(s) shielding, the source(s) driving unit, or 

3 other electronic or mechanical mechanism that could expose the source, 

4 reduce the shielding around the source(s), or compromise the radiation 

5 safety of the unit or the source(s)? 

6 Public Dose 

7 1. Is licensed material used in a manner to keep doses below 1 mSv [100 mrem] in a year 

8 [20.1301(a)(1)]? 

9 2. Has a survey or evaluation been performed per 20.1501(a)? 

10 3. Have there been any additions or changes to the storage, security, or use of surrounding 

11 areas that would necessitate a new survey or evaluation? 

12 4. Do unrestricted area radiation levels exceed 0.02 mSv [2 mrem] in any one hour 

13 [20.1301(a)(2)]? 

14 5. Is licensed material used or stored in a manner that would prevent unauthorized access 

15 or removal [20.1801 and 20.1802]? 

16 6. Are records maintained [20.2103, 20.2107]? 

17 Patient Release 

18 1. Individuals released when total effective dose equivalent (TEDE) is less than 5 mSv [0.5 

19 rem] [35.75(a)]? 

20 2. Instructions to the released individual, including breastfeeding women, include required 

21 information [35.75(b)]? 

22 3. Release records maintained [35.2075(a)]? 

23 4. Records of instructions given to breastfeeding women maintained, if required 

24 [35.2075(b)]? 

25 Unsealed Byproduct Material for Which a Written Directive Is Required 

26 1. Safety precautions implemented to include patient facilities, posting, stay times, patient 

27 safety guidance, release, and contamination controls [35.315(a)]? 

28 2. RSO and AU promptly notified if patient had a medical emergency or died [35.315(b)]? 

29 Brachytherapy or Brachytherapy Source Use 

30 1. Safety precautions implemented to include patient facilities, posting, stay times, and 

31 emergency response equipment [35.415]? 

32 2. Survey immediately after implant [35.404(a)]? 
L–11 

1 3. Patients surveyed immediately after removing the last temporary implant source 

2 [35.404(b)]? 

3 4. RSO and AU promptly notified if patient had a medical emergency or died [35.415(c)]? 

4 5. Records maintained [35.2404]? 

5 Radioactive Waste 

6 1. Disposal: 

7 a. Decay-in-storage [35.92]? 

8 b. Procedures followed? 

9 c. Labels removed or defaced [20.1904, 35.92]? 

10 2. Special procedures performed as required? 

11 3. Authorized disposals [20.2001]? 

12 4. Records maintained [20.2103(a), 20.2108, 35.2092]? 

13 5. Effluents: 

14 a. Release to sanitary sewer [20.2003]? 

15 i. Material is readily soluble or readily dispersible [20.2003(a)(1)]? 

16 ii. Monthly average release concentrations do not exceed 10 CFR Part 20, 

17 Appendix B, Table 2 values? 

18 iii. No more than 5 curies (Ci) of H-3, 1 Ci of C-14, and 1 Ci of all other 

19 radionuclides combined, released in a year [20.2003]? 

20 iv. Procedures to ensure representative sampling and analysis implemented 

21 [20.1501]? 

22 b. Release to septic tanks [20.2003]? Within unrestricted limits [10 CFR Part 20, 

23 Appendix B, Table 2]? 

24 c. Waste incinerated? 

25 i. License authorizes [20.2004(a)(3)]? 

26 ii. Exhaust directly monitored? 

27 iii. Airborne releases evaluated and controlled [20.1302, 20.1501]? 

28 d. Air effluents and ashes controlled [20.1101, 20.1201, 20.1301, 20.1501, 

29 20.2001]? (See also Inspection Procedure 87102, RG 8.37.) 

30 i. Air effluent less than 0.10 mSv [10 mrem] constraint limit [20.1101]? 

31 1. If no, reported appropriate information to the NRC? 

32 2. If no, corrective actions implemented and on schedule? 
L–12 

1 ii. Description of effluent program: 

2 1. Monitoring system hardware adequate? 

3 2. Equipment calibrated, as appropriate? 

4 3. Air samples/sampling technique (e.g., charcoal, high-efficiency 

5 particulate air) analyzed with appropriate instrumentation? 

6 6. Waste storage: 

7 a. Protection from elements and fire? 

8 b. Control of waste maintained [20.1801and 20.1802]? 

9 c. Containers properly labeled and area properly posted [20.1902, 20.1904]? 

10 d. Package integrity adequately maintained? 

11 7. Waste disposal: 

12 a. Sources transferred to authorized individuals [20.2006, 20.2001, 30.41]? 

13 b. Name of organization: ______________________ . 

14 c. Copy of waste disposal recipient’s license on file? 

15 8. Records of surveys and material accountability maintained [20.2103, 20.2108, 35.2092]? 

16 Receipt and Transfer of Radioactive Material 

17 1. Description of how packages are received and by whom? 

18 2. Written package-opening procedures established and followed [20.1906(e)]? 

19 3. All incoming packages with a U.S. Department of Transportation (DOT) label monitored 

20 for radioactive contamination, unless exempted (gases and special form) 

21 [20.1906(b)(1)]? 

22 4. Incoming packages surveyed [20.1906(b)(2)]? 

23 5. Monitoring in (C) and (D) performed within time specified [20.1906(c)]? 

24 6. Transfer(s) performed per [30.41]? 

25 7. All sources surveyed before shipment and transfer [20.1501(a)]? 

26 8. Records of surveys and receipt/transfer maintained [20.2103(a), 30.51]? 

27 9. Package receipt/distribution activities evaluated for compliance with 20.1301? 

28 Transportation (10 CFR 71.5(a) and 49 CFR 171-178) 

29 1. Shipments are: 

30 a. Delivered to common carriers? 

31 b. Transported in own private vehicle? 
L–13 

1 c. Both? 

2 d. No shipments since last audit? 

3 2. Return radiopharmacy doses to drug manufacture or commercial nuclear pharmacy or 

4 sealed sources to source or device manufacturer? 

5 a. Licensee assumes shipping responsibility? 

6 b. If “NO,” describe arrangements made between licensee and radiopharmacy for 

7 shipping responsibilities. 

8 3. Packages: 

9 a. Authorized packages used [49 CFR 173.415, 416]? 

10 b. Performance test records on file? 

11 i. DOT-7A packages 

12 ii. special form sources 

13 c. Two labels (White-I, Yellow-II, Yellow-III) with Transport Index (TI), Nuclide, 

14 Activity, and Hazard Class? 

15 d. Properly marked [Shipping Name, United Nations (UN) Number, Weight, 

16 Package Type, Reportable Quantity, “This End Up” (liquids), Name and Address 

17 of consignee] [49 CFR 172.403, 172.441, 173.471]? 

18 e. Closed and sealed during transport [49 CFR 173.475(f)]? 

19 4. Shipping Papers: 

20 a. Prepared and used [49 CFR 172.200(a)]? 

21 b. Contain proper entries (Shipping Name; Hazard Class; Identification Number (UN 

22 Number); Total Quantity; Package Type; Nuclide; Reportable Quantity; Physical 

23 and Chemical Form; Activity; Category of Label; TI; Shipper’s Name, Certification 

24 and Signature; Emergency Response Telephone Number; “Limited Quantity” {if 

25 applicable); “Cargo Aircraft Only” (if applicable)} [49 CFR 172.200-204]? 

26 c. Readily accessible during transport [49 CFR 177.817(e)]? 

27 5. Any incidents reported to DOT [49 CFR 171.15, 171.16]? 

28 Teletherapy and Gamma Stereotactic Radiosurgery 

29 1. Inspection and servicing performed following source replacement or at intervals not to 

30 exceed 5 years [35.655(a)]? 

31 2. Needed service arranged for as identified during the inspection? 

32 3. Service performed by persons specifically authorized to do so [35.655(b)]? 

33 4. Were security requirements implemented, if applicable? [10 CFR Part 37] 
L–14 

1 Full Calibration-Therapeutic Medical Devices 

2 1. Proper protocol(s) used (e.g., AAPM Task Group (TG)–21 (TG-21), AAPM 54, AAPM 

3 TG-56, AAPM TG-40)? 

4 2. Performed prior to first patient use [35.632(a)(1), 35.633(a)(1), 35.635(a)(1)]? 

5 3. At intervals not to exceed 1 year for teletherapy, gamma stereotactic radiosurgery 

6 (GSR), and low dose-rate (LDR) remote afterloader; at intervals not exceeding 1 quarter 

7 for high dose-rate, medium dose-rate (MDR), and pulsed dose-rate (PDR) remote 

8 afterloaders [35.632(a)(3), 35.633(a)(3) and (4), 35.635(a)(3)]? 

9 4. Whenever spot-checks indicate output differs from expected by ±5% [35.632(a)(2)(i), 

10 35.635(a)(2)(i)]? 

11 5. After source exchange, relocation, and major repair or modification [35.632(a)(2), 

12 35.633(a)(2), 35.635(a)(2)]? 

13 6. Performed with properly calibrated instrument [35.632(c), 35.633(c), 35.635(c)]? 

14 7. Includes: 

15 a. For teletherapy: 

16 i. Output measured within ±3% of expected for the range of field sizes, 

17 range of distances [35.632(b)(1)]? 

18 ii. Coincidence of radiation field and field light localizer [35.632(b)(2)]? 

19 iii. Uniformity of radiation field and beam angle dependence [35.632(b)(3)]? 

20 iv. Timer accuracy and linearity over the range of use [35.632(b)(4)]? 

21 v. On-off error [35.632(b)(5)]? 

22 vi. Accuracy of all measuring and localization devices [35.632(b)(6)]? 

23 b. For remote afterloaders: 

24 i. Output measured within ±5% of expected [35.633(b)(1)]? 

25 ii. Source positioning accuracy within ±1 millimeter [35.633(b)(2)]? 

26 iii. Source retraction with backup battery upon power failure [35.633(b)(3)]? 

27 iv. Length of source transfer tubes [35.633(b)(4)]? 

28 v. Timer accuracy and linearity over the typical range of use [35.633(b)(5)]? 

29 vi. Length of the applicators [35.633(b)(6)]? 
L–15 

1 vii. Function of source transfer tubes, applicators, and transfer 

2 tube-applicator interfaces [35.633(b)(7)]? 

3 viii. Autoradiograph quarterly of the LDR source(s) to verify source(s) 

4 arrangement and inventory [35.633(e)]? 

5 c. For gamma stereotactic radiosurgery: 

6 i. Output measured within ±3% of expected [35.635(b)(1)]? 

7 ii. Helmet factors [35.635(b)(2)]? 

8 iii. Isocenter coincidence [35.635(b)(3)]? 

9 iv. Timer accuracy and linearity over the range of use [35.635(b)(4)]? 

10 v. On-off error [35.635(b)(5)]? 

11 vi. Trunnion centricity [35.635(b)(6)]? 

12 vii. Treatment table retraction mechanism, using backup battery power or 

13 hydraulic backups with the unit off [35.635(b)(7)]? 

14 viii. Helmet microswitches [35.635(b)(8)]? 

15 ix. Emergency timing circuit [35.635(b)(9)]? 

16 x. Stereotactic frames and localizing devices (trunnions) [35.635(b)(10)]? 

17 8. Output corrected mathematically for decay [35.632(e), 35.633(g), 35.635(e)]? 

18 9. Records maintained [35.2632]? 

19 Periodic Spot-Checks for Therapeutic Devices 

20 1. Performed at required frequency [35.642(a), 35.643(a), 35.645(a)]? 

21 2. Procedures established by AMP [35.642(b), 35.643(b), 35.645(b)]? 

22 3. Procedures followed? 

23 4. Medical physicist reviews results within 15 days [35.642(c), 35.643(c), 35.645(b)]? 

24 5. Performed with properly calibrated instrument [35.642(a)(5), 35.645(c)(2)(i)]? 

25 6. Output and safety spot-checks include: 

26 a. For teletherapy: 

27 i. Timer accuracy and linearity over the range of use [35.642(a)(1)]? 

28 ii. On-off error [35.642(a)(2)]? 

29 iii. Coincidence of radiation field and field light localizer [35.642(a)(3)]? 
L–16 

1 iv. Accuracy of all measuring and localization devices [35.642(a)(4)]? 

2 v. The output for one typical set of operating conditions [35.642(a)(5)]? 

3 vi. Difference between measured and expected output [35.642(a)(6)]? 

4 vii. Interlock systems [35.642(d)(1)]? 

5 viii. Beam stops [35.642(d)(2)]? 

6 ix. Source exposure indicator lights [35.642(d)(3)]? 

7 x. Viewing and intercom systems [35.642(d)(4)]? 

8 xi. Treatment room doors, inside and out [35.642(d)(5)]? 

9 xii. Electrical treatment doors with power shut off [35.642(d)(6)]? 

10 b. For remote afterloaders: 

11 i. Interlock systems [35.643(d)(1)]? 

12 ii. Source exposure indicator lights [35.643(d)(2)]? 

13 iii. Viewing and intercom systems, except for LDR [35.643(d)(3)]? 

14 iv. Emergency response equipment [35.643(d)(4)]? 

15 v. Radiation monitors used to indicate source position [35.643(d)(5)]? 

16 vi. Timer accuracy [35.643(d)(6)]? 

17 vii. Clock (date and time) in the unit’s computer [35.643(d)(7)]? 

18 viii. Decayed source(s) activity in the unit’s computer [35.643(d)(8)]? 

19 c. For gamma stereotactic radiosurgery: 

20 i. Treatment table retraction mechanism [35.645(c)(1)(i)]? 

21 ii. Helmet microswitches [35.645(c)(1)(ii)]? 

22 iii. Emergency timing circuits [35.645(c)(1)(iii)]? 

23 iv. Stereotactic frames and localizing devices [35.645(c)(1)(iv)]? 

24 v. The output for one typical set of operating conditions [35.645(c)(2)(i)]? 

25 vi. Difference between measured and expected output [35.645(c)(2)(ii)]? 

26 vii. Source output compared against computer calculation of output 

27 [35.645(c)(2)(iii)]? 

28 viii. Timer accuracy and linearity over the range of use [35.645(c)(2)(iv)]? 

29 ix. On-off error [35.645(c)(2)(v)]? 

30 x. Trunnion centricity [35.645(c)(2)(vi)]? 

31 xi. Automatic positioning system? 

32 xii. Interlock systems [35.645(d)(1)]? 

33 xiii. Source exposure indicator lights [35.645(d)(2)]? 

34 xiv. Viewing and intercom systems [35.645(d)(3)]? 
L–17 

1 xv. Timer termination [35.645(d)(4)]? 

2 xvi. Radiation monitors used to indicate room exposures [35.645(d)(5)]? 

3 xvii. Emergency off buttons [35.645(d)(6)]? 

4 7. Licensee promptly repaired items found to be not operating properly and did not use unit 

5 until repaired, if required [35.642(e), 35.643(e), 35.645(f)]? 

6 8. Records maintained [35.2642, 35.2643, 35.2645]? 

7 Installation, Maintenance, and Repair of Therapy Devices 

8 1. Only authorized individuals perform installation, maintenance, adjustment, repair, and 

9 inspection [35.605, 35.655]? Name of organization/individual. 

10 2. License verification? 

11 3. Records maintained [35.2605, 35.2655]? 

12 Emergency Procedures for Therapy Devices 

13 1. Instructions on location of emergency procedures and emergency response telephone 

14 numbers posted at the device console [35.610(c)]? 

15 2. Copy of the entire procedures physically located at the device console [35.610(b)]? 

16 3. Procedures include: 

17 a. Instructions for responding to equipment failures and the names of the individuals 

18 responsible for implementing corrective actions [35.610(a)(4)]? 

19 b. The process for restricting access to and posting of the treatment area to 

20 minimize the risk of inadvertent exposure [35.610(a)(4)]? 

21 c. The names and telephone numbers of the AUs, the AMP, and the RSO to be 

22 contacted if the unit or console operates abnormally [35.610(a)(4)]? 

23 4. AMP and AU: 

24 a. Physically present during initiation of patient treatment with remote afterloaders? 

25 (Note: for MDR and PDR, an appropriately trained physician under the 

26 supervision of the AU may be physically present instead of the AU) [35.615(f)(1) 

27 and (2)]. 

28 b. Physically present throughout all patient treatments with a gamma stereotactic 

29 radiosurgery device [35.615(f)(3)]? 

30 Patient Surveys and Therapy Devices 

31 1. Radiation survey of patient is performed to ensure source is returned to shielded position 

32 [35.604(a)]? 
L–18 

1 2. RSO and AU promptly notified if patient had a medical emergency or died [35.615(f)(4)]? 

2 3. Records of radiation surveys maintained for 3 years [35.2404]? 

3 Personnel Radiation Protection 

4 1. Exposure evaluation performed [20.1501]? 

5 2. As low as is reasonably achievable (ALARA) program implemented [20.1101(b)]? 

6 3. External Dosimetry: 

7 a. Monitors workers per [20.1502(a)]? 

8 b. External exposures account for contributions from airborne activity [20.1203]? 

9 c. Supplier Frequency 

10 d. Supplier is National Voluntary Laboratory Accreditation Program -approved 

11 [20.1501(c)]? 

12 e. Dosimeters exchanged at required frequency? 

13 4. Internal Dosimetry: 

14 a. Monitors workers per 20.1502? 

15 b. Program for monitoring and controlling internal exposures [20.1701, 20.1702] 

16 briefly described? 

17 c. Monitoring/controlling program implemented (includes bioassays)? 

18 d. Respiratory protection equipment [20.1703]? 

19 5. Review of Records and Reports: 

20 a. Reviewed by _________ Frequency_________ 

21 b. Auditor reviewed personnel monitoring records for period _________ to 

22 ________ 

23 c. Prior dose determined for individuals likely to receive doses [20.2104]? 

24 d. Maximum exposures TEDE _________ Other _________ 

25 e. Maximum committed dose equivalents (CDEs) _________ Organs 

26 f. Maximum CEDE _________ 

27 g. Internal and external summed [20.1202]? 

28 h. Occupational limits met for adults [20.1201]? 
L–19 

1 i. If applicable, occupational limits met for minors [20.1202]? 

2 j. NRC forms or equivalent [20.2104(d), 20.2106(c)]? 

3 i. NRC-4 Complete: 

4 ii. NRC-5 Complete: 

5 k. If a worker declared her pregnancy during the audit period, was the dose in 

6 compliance [20.1208] and were the records maintained [20.2106(e)]? 

7 6. Any planned special exposures (number of people involved and doses received) 

8 [20.1206, 20.2104, 20.2105, 20.2204]? 

9 7. Records of exposures, surveys, monitoring, and evaluations maintained [20.2102, 

10 20.2103, 20.2106]? 

11 Security Program for Category 1 and Category 2 Materials [10 CFR Part 37] 

12 1. Background investigations and access control program [10 CFR Part 37, Subpart B]? 

13 2. Security program content and implementation reviewed annually and maintain records for 

14 3 years [10 CFR 37.55] 

15 3. Physical protection in transit [10 CFR Part 37, Subpart D]? 

16 4. Records [10 CFR Part 37, Subpart F]?

17 Confirmatory Measurements 

18 1. Detail location and results of confirmatory measurements. 

19 Medical Events 

20 If medical events meeting the criteria in 35.3045 have occurred since the last audit, evaluate the 

21 incident(s) and procedures for implementing and administering WDs using the existing 

22 guidance. 

23 1. Event date ___________ Information Source ____________________ 

24 2. Notifications: 

25 NRC Ops Center NRC Region 

26 Referring Physician Patient 

27 In writing By telephone 

28 If notification did not occur, why not? 

29 3. Written Reports [35.3045]: Submitted to Region within 15 days? 

30 4. Patient intervention that resulted in the total dose or dosage not being administered? 

31 Describe each intervention. 
L–20 

1 Notification and Reports 

2 1. In compliance with 10 CFR 19.13, and 10 CFR 30.50 (reports to individuals, public and 

3 occupational, monitored to show compliance with Part 20)? 

4 2. In compliance with 10 CFR 20.2201, and 10 CFR 30.50 (theft or loss)? 

5 3. In compliance with 10 CFR 20.2202, and 10 CFR 30.50 (incidents)? 

6 4. In compliance with 10 CFR 20.2203, and 10 CFR 30.50 (overexposure and high 

7 radiation levels)? 

8 5. Licensee in compliance with 10 CFR 21.21 (device defect)? 

9 6. Aware of NRC Operations Center telephone number? 

10 7. In compliance with 10 CFR 20.2203 (constraint on air emissions)? 

11 Posting and Labeling 

12 1. NRC Form 3, “Notice to Workers” is posted [19.11]? 

13 2. 10 CFR Parts 19, 20, 21, Section 206 of Energy Reorganization Act, procedures 

14 adopted pursuant to 10 CFR Part 21, and license documents are posted, or a notice 

15 indicating where documents can be examined is posted [19.11, 21.6]? 

16 3. Other posting and labeling per 10 CFR 20.1902, 20.1904, and not exempted by 20.1903, 

17 20.1905? 

18 Recordkeeping for Decommissioning 

19 1. Records of information important to the safe and effective decommissioning of the facility 

20 maintained in an independent and identifiable location until license termination 

21 [30.35(g)]? 

22 2. Records include all information outlined in 10 CFR 30.35(g)? 

23 Bulletins and Information Notices (IN) 

24 1. Bulletins, INs, Newsletters, etc., received? To receive these documents electronically, 

25 subscribe to the Medical List Server by sending an e-mail to 

26 “Medical-GC.Resource@nrc.gov” with the word ‘subscribe’ in the subject line. 

27 2. Appropriate action in response to Bulletins, Generic Letters, etc.? 
L–21 

1 Special License Conditions or Issues (L/C) 

2 Special license condition or issues to be reviewed: 

3 a. If authorized for 10 CFR 35.1000 medical uses, review the program for 

4 conformance with license application commitments, license conditions, and 

5 regulations. 

6 b. Other special license conditions. 

7 Performance-Based Review

8 1. Conduct performance-based reviews of radiation workers performing licensed activities: 

9 a. to assess the capability of the radiation workers to maintain exposures ALARA; 

10 b. to assess that radiation workers follow the operating procedures; 

11 c. to assess the effectiveness of the operating procedures and compliance with the 

12 regulations, license conditions and the licensee commitments submitted in 

13 support of a license (and incorporated by “tie-down” conditions); 

14 d. to ensure the safe and secure use of radioactive material; 

15 e. to verify that radiation workers are cognizant of the emergency procedures and, if 

16 necessary, would be able to implement them and maintain exposures ALARA; 

17 and 

18 f. to ensure that emergency procedures have been developed for all likely 

19 scenarios. 

20 2. Take the necessary actions to address programmatic and performance deficiencies with 

21 radiation workers and facilitate immediate corrective actions. 

22 Evaluation of Other Factors 

23 1. Senior licensee management is appropriately involved with the radiation safety program 

24 and/or RSO oversight? 

25 2. RSO has sufficient time to perform radiation safety duties and is not too busy with other 

26 assignments? 

27 3. Licensee has sufficient staff? 

28 Audits and Findings

29 1. Summary of findings. 

30 2. Corrective and preventive actions. 

31 3. Amendment required? 
1 
1 APPENDIX M 

2 MODEL PROCEDURES FOR OCCUPATIONAL DOSE PROGRAM 

M–1 

1 Model Procedures for Occupational Dose Program 

2 This model provides acceptable procedures for an external occupational dose program and 

3 references and resources for developing an internal occupational dose program. Applicants 

4 may either adopt these model procedures for an external occupational dose program or develop 

5 alternative procedures to meet the requirements of Title 10 of the Code of Federal Regulations

6 (CFR) 10 CFR 20.1101 and Subparts C (“Occupational Dose Limits”) and F (“Surveys and 

7 Monitoring”) of 10 CFR Part 20. The model includes guidance as well as a discussion of 

8 regulatory requirements that are to be reflected in the elements of an occupational dose 

9 program. 

10 “Dosimetry” is a broad term commonly applied to the use of monitoring devices, bioassay, and 

11 other methods to measure or otherwise quantify radiation doses to individuals. The licensee 

12 must control occupational doses and provide individuals with monitoring devices in accordance 

13 with the requirements of 10 CFR 20.1502(a). The occupational dose limits for adults are 

14 provided in 10 CFR 20.1201, while 10 CFR 20.1502, “Conditions requiring individual monitoring 

15 of external and internal occupational dose,” provides, in part, that adults likely to receive in a 

16 year a dose in excess of 10% of those dose limits must be provided with dosimetry. Definitions 

17 of relevant terms such as total effective dose equivalent (TEDE), deep-dose equivalent (DDE), 

18 and committed effective dose equivalent (CEDE) can be found in 10 CFR 20.1003, “Definitions.” 

19 In addition, if monitoring is required pursuant to 10 CFR 20.1502, each licensee shall maintain 

20 records of doses received (see 10 CFR 20.2106, “Records of individual monitoring results”) and 

21 individuals must be informed of their doses on at least an annual basis (see 10 CFR 19.13(b), 

22 “Notifications and reports to individuals”). 

23 The licensee must consider the dose that an individual may receive in the current year from all 

24 sources of employment where the individual's assigned duties involve exposure to sources of 

25 radiation. 

26 If an individual is likely to receive more than 10% of the annual dose limits, the NRC requires 

27 the licensee to monitor the dose, to maintain records of the dose, and, on at least an annual 

28 basis, to inform the worker of his or her dose. 

29 The As-Low-As-Reasonably-Achievable “ALARA” Program 

30 Regulations in 10 CFR 20.1101 state that “each licensee shall develop, document, and 

31 implement a radiation protection program commensurate with the scope and extent of licensed 

32 activities” and “the licensee shall use, to the extent practical, procedures and engineering 

33 controls based upon sound radiation protection principles to achieve occupational doses and 

34 doses to members of the public that are as low as is reasonably achievable (ALARA).” 

35 Additionally, 10 CFR 20.1101 requires that licensees periodically review the content of the 

36 radiation protection program and its implementation. 

37 External Exposure 

38 It is necessary to assess doses to radiation workers to demonstrate compliance with regulatory 

39 limits on radiation dose and to help demonstrate that doses are maintained at ALARA levels. 

40 Providing for the safe use of radioactive materials and radiation is a management responsibility. 

41 It is important that management recognize the importance of radiation monitoring in the overall 

42 requirements for radiation protection. 
M–2 

1 There are three dose limits included in 10 CFR 20.1201 that apply to external exposure: deep 

2 dose to the whole body [5 rem or 0.05 Sievert (Sv)], shallow dose to the skin or extremities (50 

3 rem or 0.5 Sv), and dose to the lens of the eye (15 rem or 0.15 Sv). According to the definitions 

4 in 10 CFR 20.1003, the DDE to the whole body is considered to be at a tissue depth of 1 

centimeter (cm) [1,000 milligram (mg)/square centimeters (cm2 5 )], shallow-dose equivalent (SDE) 

to the skin or extremities at 0.007 cm [7 mg/cm2 6 ], and eye dose equivalent at 0.3 cm 

[300 mg/cm2 7 ]. In evaluating the eye dose equivalent, it is acceptable to take credit for the 

8 shielding provided by protective lenses. 

9 Under 10 CFR 20.1502(a), the use of individual monitoring devices is required for the following: 

10  Adults likely to receive, in a year, from sources external to the body, a dose in excess of 

11 10% of the occupational dose limits in 10 CFR 20.1201(a). Monitoring devices are 

12 accordingly required for adults with an annual dose in excess of 

13 — 0.5 rem [0.005 Sv] DDE 

14 — 1.5 rem [0.015 Sv] eye dose equivalent 

15 — 5 rem [0.05 Sv] SDE to the skin 

16 — 5 rem [0.05 Sv] SDE to any extremity 

17  Minors who are likely to receive an annual dose in excess of: 

18 — 0.1 rem [1.0 millisievert (mSv)] DDE 

19 — 0.15 rem [1.5 mSv] eye dose equivalent 

20 — 0.5 rem [5 mSv] SDE to the skin, or 

21 — 0.5 rem [5 mSv] SDE to any extremity 

22  Declared pregnant women likely to receive an annual dose in excess of 0.1 rem [1.0 

23 mSv] DDE during the entire pregnancy. 

24  Individuals entering a high- or a very-high-radiation area. 

25 To demonstrate that monitoring of occupational exposure is not necessary for a group of 

26 radiation workers, it must be demonstrated that doses will not exceed 10% of the applicable 

27 limits. In these cases, the NRC does not require licensees to monitor radiation doses for this 

28 class of worker. 

29 The following methods may be used to demonstrate that doses are expected to be within 10% 

30 of regulatory limits: 

31  Prior Experience: Reviews of radiation dose histories for workers in a specific work area 

32 show that they are not likely to receive a dose in excess of 10% of the limits. 

33  Area Surveys: Demonstrate through the conduct of appropriate radiation level surveys 

34 [e.g., using a radiation survey meter or area thermoluminescent dosimeters (TLDs)] in 

35 the work area, combined with estimates of occupancy rates and calculations, that doses 

36 to workers are not likely to exceed 10% of the limits (exposures associated with 

37 reasonable “accident” scenarios should also be evaluated). 
M–3 

1  The licensee performs a reasonable calculation, based upon source strength, distance, 

2 shielding, and time spent in the work area, that shows that workers are not likely to 

3 receive a dose in excess of 10% of the limits. 

4 External dose is determined by using individual monitoring devices, such as film badges, 

5 optically stimulated luminescence dosimeters, or TLDs. These devices must be evaluated by a 

6 processor that is National Voluntary Laboratory Accreditation Program-approved, as required by 

7 10 CFR 20.1501. 

8 The device for monitoring the whole body dose, eye dose, skin dose, or extremity dose shall be 

9 placed near the location expected to receive the highest dose during the year 

10 [10 CFR 20.1201(c)]. When the whole body is exposed fairly uniformly, the individual 

11 monitoring device is typically worn on the front of the upper torso. 

12 If the radiation dose is highly nonuniform, causing a specific part of the whole body (head, trunk, 

13 arms above the elbow, or legs above the knees) to receive a substantially higher dose than the 

14 rest of the whole body, the individual monitoring device shall be placed near that part of the 

15 whole body expected to receive the highest dose. For example, if the dose rate to the head is 

16 expected to be higher than the dose rate to the trunk of the body, a monitoring device shall be 

17 located on or close to the head. 

18 If, after the exposure is received, the licensee somehow learns that the maximum dose to a part 

19 of the whole body, eye, skin, or extremity was substantially higher than the dose measured by 

20 the individual monitoring device, an evaluation shall be conducted to estimate the actual 

21 maximum dose. 

22 Under 10 CFR 20.2106, individual monitoring must be recorded on NRC Form 5, “Occupational 

23 Dose Record for a Monitoring Period,” or equivalent. Form 5 is used to record doses received 

24 for the calendar year. The monitoring year may be adjusted as necessary to permit a smooth 

25 transition from one monitoring year to another, as long as the year begins and ends in the 

26 month of January, the change is made at the beginning of the year, and no day is omitted or 

27 duplicated in consecutive years. 

28 Because evaluation of dose is an important part of the radiation protection program, it is 

29 important that users return dosimeters on time. Licensees should be vigorous in their effort to 

30 recover any missing dosimeters. Delays in processing a dosimeter can result in the loss of the 

31 stored information. 

32 If an individual’s dosimeter is lost, the licensee needs to perform and document an evaluation of 

33 the dose the individual received and to add it to the employee’s dose record in order to 

34 demonstrate compliance with occupational dose limits in 10 CFR 20.1201. Sometimes the most 

35 reliable method for estimating an individual’s dose is to use his or her recent dose history. In 

36 other cases, particularly if the individual does nonroutine types of work, it may be better to use 

37 doses of coworkers as the basis for the dose estimate. It also may be possible to estimate 

38 doses by modeling and calculation (i.e., reconstruction) of scenarios leading to dose. 

39 Investigational Levels – External Dose Monitoring 

40 The NRC has emphasized that the Investigational Levels in this program are not new dose 

41 limits but, as noted in International Commission on Radiological Protection (ICRP) Report 26, 

42 “Recommendations of the International Commission on Radiological Protection,” Investigational 
M–4 

1 Levels serve as check points above which the results are considered sufficiently important to 

2 justify investigation. 

3 In cases where a worker’s dose or the dose for a group of workers needs to exceed an 

4 Investigational Level, a new, higher Investigational Level may be established for that individual 

5 or group on the basis that it is consistent with good ALARA practices. Justification for new 

6 Investigational Levels should be documented. 

7 When the cumulative annual exposure to a radiation worker exceeds Investigational Level I in 

8 Table M–1 (i.e., 10% of the annual limit for occupational exposure), the radiation safety officer 

9 (RSO) or the RSO’s designee should investigate the exposure and review the actions that might 

10 be taken to reduce the probability of recurrence. When the cumulative annual exposure 

11 exceeds the Investigational Level II in Table M–1 (i.e., 30% of the annual limit for occupational 

12 exposure), the RSO or the RSO’s designee will investigate the exposure and review actions to 

13 be taken to reduce the probability of recurrence, and management should review the report of 

14 the actions to be taken to reduce the probability of occurrence. 

Table M–1. Investigational Levels 

Part of Body Investigational Level I 

(mrem/yr)

Investigational Level II 

(mrem/yr)

whole body, head, trunk including 

male gonads, arms above the 

elbow, or legs above the knee 

500 [5 mSv] 1,500 [15 mSv] 

hands, elbows, arms below the 

elbow, feet, knees, legs below the 

knee, or skin 

5,000 [50 mSv] 15,000 [150 mSv] 

lens of the eye 1,500 [15 mSv] 4,500 [45 mSv] 

15 Review and record on NRC Form 5, “Occupational Dose Record for a Monitoring Period,” or an 

16 equivalent form (e.g., dosimeter processor’s report), results of personnel monitoring. Take the 

17 actions listed below when the investigation levels listed in Table M–1 are reached: 

18  Personnel dose less than Investigational Level I. 

19 Except when deemed appropriate by the RSO or the RSO’s designee, no further action will be 

20 taken if an individual’s dose is less than Table M–1 values for Investigational Level I. 

21  Personnel dose equal to or greater than Investigational Level I but less than 

22 Investigational Level II. 

23 When the dose of an individual equals or exceeds Investigational Level I, the RSO or the RSO’s 

24 designee should conduct a timely investigation and review the actions that might be taken to 

25 reduce the probability of recurrence, following the period when the dose was recorded. If the 

26 dose does not equal or exceed Investigational Level II, no action related specifically to the 

27 exposure is required, unless deemed appropriate by the RSO or the RSO’s designee. Consider 

28 investigating the factors that led to the radiation exposure and the radiation doses and work 

29 habits of other individuals engaged in similar tasks to determine if improvements or additional 

30 safety measures are needed to reduce exposures. Evaluate, in the context of ALARA program 

31 quality, and record the results of investigations and evaluations. 
M–5 

1  Personnel dose equal to or greater than Investigational Level II. 

2 The RSO should investigate in a timely manner the causes of all personnel doses equaling or 

3 exceeding Investigational Level II. The RSO should consider actions to reduce the probability of 

4 occurrence, and a report of the actions should be reviewed by the licensee’s management at its 

5 first meeting following completion of the investigation. 

6  Reestablishment of Investigational Level II to a level above that listed in Table M–1. 

7 Declared Pregnancy and Dose to Embryo/Fetus 

8 Regulations in 10 CFR 20.1208, “Dose equivalent to an embryo/fetus,” state that the licensee 

9 shall ensure that the dose to an embryo or fetus during the entire pregnancy, due to 

10 occupational exposure of a declared pregnant woman, does not exceed 0.5 rem [5 mSv]. The 

11 licensee shall make efforts to avoid substantial variation above a uniform monthly exposure rate 

12 to a declared pregnant woman. If the pregnancy is declared in writing and includes the worker’s 

13 estimated date of conception, the dose equivalent to an embryo or fetus shall be taken as the 

14 sum of 

15  the DDE to the declared pregnant woman 

16  the dose equivalent to the embryo/fetus from radionuclides in the embryo/fetus and 

17 radionuclides in the declared pregnant woman 

18 Licensees should reference RG 8.13, “Instructions Concerning Prenatal Radiation Exposure,” 

19 June 1999, for information to help pregnant women and other personnel make decisions 

20 regarding radiation exposure during pregnancy and RG 8.36, “Radiation Dose to the 

21 Embryo/Fetus,” July 1992, for calculating the radiation dose to the embryo/fetus. 

22 Internal Exposure 

23 With respect to internal exposure, licensees are required to monitor occupational intake of 

24 radioactive material and assess the resulting dose if it appears likely that personnel will receive 

25 greater than 10% of the annual limit on intake (ALI) from intakes in a year (10 CFR 20.1502). 

26 Terms for radionuclide intakes by means of inhalation and ingestion (i.e., derived air 

27 concentration (DAC) and ALI) are provided in 10 CFR Part 20. 

28 The DAC for each class of radionuclide is the concentration of airborne radioactivity in 

29 microcurie (μCi)/milliliter that, if an occupational worker were to be continuously exposed to it for 

30 2,000 hours (1 year), would result in either a CEDE of 5 rem [0.05 Sv] to the whole body or a 

31 committed dose equivalent of 50 rem [0.5 Sv] to any individual organ or tissue, with no 

32 consideration for the contribution of external dose. The ALI and DAC for each radionuclide in a 

33 specific chemical form are listed in Appendix B of 10 CFR Part 20.

34 For each class of each radionuclide, there are two ALIs, one for ingestion and one for inhalation. 

35 The ALI is the quantity of radioactive material that, if taken into the body of an adult worker by 

36 the corresponding route, would result in a committed effective dose equivalent of 5 rem 

37 [0.05 Sv] or a committed dose equivalent of 50 rem [0.5 Sv] to any individual organ or tissue; 

38 again, with no consideration for the contribution of external dose. 
M–6 

1 The TEDE concept makes it possible to combine both the internal and external doses in 

2 assessing the overall risk to the health of an individual. The ALI and DAC numbers in 

3 10 CFR Part 20 reflect the doses to all principal organs that are irradiated. The ALI and DAC 

4 were derived by multiplying a unit intake by the appropriate organ weighting factors (WT), for the 

5 organs specifically targeted by the radionuclide compound, and then summing the 

6 organ-weighted doses to obtain a whole body risk-weighted “effective dose.” Per 10 CFR Part 

7 20, Appendix B, when an ALI is defined by the stochastic dose limit, this value alone is given. 

8 When the ALI is determined by the nonstochastic dose limit to an organ, the organ or tissue to 

9 which the limit applies is shown, and the ALI for the stochastic limit is shown in parentheses. 

10 The types and quantities of radioactive material manipulated at most medical facilities do not 

11 provide a reasonable possibility for an internal intake by workers. However, uses such as 

12 preparing radioiodine capsules from liquid solutions, and opening and dispensing radioiodine 

13 from vials containing millicurie quantities, require particular caution. To monitor internal 

14 exposures from such operations, a routine bioassay program to periodically monitor workers 

15 should be established. 

16 If a licensee determines that a program for performing thyroid uptake bioassay measurements is 

17 necessary, a program should be established. The program should include 

18  adequate equipment to perform bioassay measurements 

19  procedures for calibrating the equipment, including factors necessary to convert counts 

20 per minute into becquerel or μCi units 

21  the technical problems commonly associated with performing thyroid bioassays 

22 (e.g., statistical accuracy, attenuation by neck tissue) 

23  the interval between bioassays 

24  action levels 

25  the actions to be taken at those levels 

26 For additional guidance on developing occupational dose programs refer to the following: 

27  Regulatory Guide (RG) 8.9, “Acceptable Concepts, Models, Equations and Assumptions 

28 for a Bioassay Program,” July 1993. 

29  RG 8.34, “Monitoring Criteria and Methods to Calculate Occupational Radiation Doses,” 

30 July 1992. 

31  National Council on Radiation Protection and Measurements (NCRP) Report No. 87, 

32 “Use of Bioassay Procedures for Assessment of Internal Radionuclide Deposition,” 

33 February 1987. 

34  NUREG/CR–4884, “Interpretation of Bioassay Measurements,” July 1987. 

35  NUREG–1400, “Air Sampling in the Workplace,” September 1993. 
M–7 

1 Recordkeeping 

2 Records of measurement data, calculations of intakes, and methods for calculating dose must 

3 be maintained as required by 10 CFR 20.2106. For additional information on recordkeeping 

4 and reporting occupational exposure data, including intakes, refer to RG 8.7, “Instructions for 

5 Recording and Reporting Occupational Radiation Dose Data,” November 2005. 

6 Summation of External and Internal Doses 

7 Pursuant to 10 CFR 20.1202, “Compliance with requirements for summation of external and 

8 internal doses,” the external and internal doses must be summed if required to monitor both 

9 under 10 CFR 20.1502. Regulatory Issue Summary (RIS) 2002-06, “Evaluating Occupational 

10 Dose for Individuals Exposed to NRC-Licensed Material and Medical X-Rays,” April 16, 2002, 

11 contains helpful information regarding occupational doses. 

1 APPENDIX N 

2 MODEL EMERGENCY PROCEDURES 

N–1 

1 Model Emergency Procedures 

2 This model provides acceptable procedures for responding to emergencies involving spills or 

3 patients administered therapeutic amounts of radionuclides. Applicants using unsealed licensed 

4 material may either adopt this model or develop alternative procedures to meet the 

5 requirements of Title 10 of the Code of Federal Regulations (10 CFR) 20.1101. Applicants 

6 using therapeutic sealed sources should develop procedures specific to each use.

7 General Safety Procedures to Handle Spills 

8 The name and telephone number of the radiation safety officer (RSO) should be posted 

9 conspicuously in areas of use, so that it is readily available to workers in case of emergencies. 

10 Licensee should have emergency equipment readily available for handling spills. 

11 Spill/contamination kits should include the following items:

12  disposable gloves

13  disposable lab coats

14  disposable head coverings

15  disposable shoe covers

16  roll of absorbent paper with plastic backing

17  masking tape

18  plastic trash bags with twist ties

19  “radioactive material” labeling tape

20  marking pen

21  prestrung “Radioactive Material” labeling tags

22  contamination wipes

23  instructions for “Emergency Procedures”

24  clipboard with copy of Radioactive Spill Report Form

25  pencil

26  appropriate survey instruments, including batteries 

27 The decision to implement a major spill/contamination procedure instead of a minor 

28 spill/contamination procedure depends on many incident-specific variables, such as the number 

29 of individuals affected, other hazards present, likelihood of contamination spread, types of 

30 surfaces contaminated, and radiotoxicity of the spilled material. 

31 For some spills of radionuclides with half-lives shorter than 24 hours and in amounts less than 

32 five times the lowest annual limit on intake (ALI), an alternative spill/contamination procedure 

33 may be to restrict access pending complete decay. In most cases, determination of a major 

34 versus minor spill should be based on the lowest ALI. 

35 The licensee should estimate the amount of radioactivity spilled and initiate a major or minor 

36 spill/contamination procedure. Use Table N–1 as general guidance to determine whether a 

37 major spill/contamination procedure or a minor spill/contamination procedure will be 

38 implemented. Spills above these millicurie (mCi) amounts are considered major, and spills 

39 below these levels are considered minor. 

Appropriate first aid and other immediate medical needs of injured individuals should not be 

neglected, delayed, or ignored due to suspected contamination. 
N–2 

Table N–1 Relative Hazards of Common Radionuclides 

Radionuclide mCi Radionuclide mCi

nitrogen-13 100 technetium-99m 100 

carbon-14 10 indium-111 10 

oxygen-15 100 iodine-123 10 

fluorine-18 100 iodine-125 1 

phosphorus-32 1 iodine-131 1 

gallium-67 10 samarium-153 10 

rubidium-82 10 ytterbium-169 10 

strontium-82 1 mercury-197 10 

strontium-85 10 gold-198 10 

strontium-89 1 thallium-201 100 

yttrium-90 1 Alpha emitters * 

*For radiopharmaceuticals where the primary emission is alpha, consider implementing major spill precautions.

1 Note: A report to U.S. Nuclear Regulatory Commission (NRC) may be required pursuant to 

2 10 CFR 30.50. 

3 Minor Spills of Liquids and Solids 

4 Instructions to Workers 

5  Notify persons in the area that a spill has occurred. 

6  Prevent the spread of contamination by covering the spill with absorbent paper. 

7  Wear gloves and protective clothing such as a lab coat and booties, and clean up the 

8 spill using absorbent paper. 

9  Carefully fold the absorbent paper with the clean side out and place in a bag labeled 

10 “caution radioactive material” for transfer to a radioactive waste container. Also put 

11 contaminated gloves and any other contaminated disposable material in the bag. 

12  Survey the area with an appropriate low-range radiation detection instrument sufficiently 

13 sensitive to detect the radionuclide. Survey for removable contamination to ensure 

14 contamination levels are below trigger levels. Survey the area around the spill. 

15  Survey hands, clothing, and shoes for contamination prior to leaving the area. 

16  Report the incident to the RSO promptly. 

17  Cooperate and follow the instructions of the RSO and the RSO staff (e.g., criteria for 

18 returning to the work area, investigation of root cause, provision of requested bioassay 

19 samples, decontamination techniques, surveys, provision of bioassay samples, 

20 requested documentation). 

21 Reminders to RSO 

22  Follow up on the decontamination activities and document the results.
N–3 

1  As appropriate, determine cause and corrective actions needed; consider bioassays if 

2 licensed material may have been ingested, inhaled, or absorbed through the skin.

3  If necessary, notify the NRC. 

4 Major Spills of Liquids and Solids 

5 Instructions to Workers 

6  Clear the area. Notify all persons not involved in the spill to vacate the room. 

7  Prevent the spread of contamination by covering the spill with absorbent paper labeled 

8 “caution radioactive material,” but do not attempt to clean it up. Paper should be 

9 dampened, if solids are spilled. To prevent further spread of contamination, clearly 

10 indicate the boundaries of the spill and limit the movement of all personnel who may be 

11 contaminated. 

12  Shield the source only if it can be done without further contamination or a significant 

13 increase in radiation exposure. 

14  Close the room and lock or otherwise secure the area to prevent entry. Post the room 

15 with a sign to warn anyone trying to enter that a spill of radioactive material has 

16 occurred. 

17  Notify the RSO immediately. 

18  Survey all personnel who could possibly have been contaminated. Decontaminate 

19 personnel by removing contaminated clothing and flushing contaminated skin with 

20 lukewarm water, then washing with mild soap. 

21  Cooperate and follow the instructions of the RSO and the RSO staff (e.g., criteria for 

22 returning to the work area, investigation of root cause, provision of requested bioassay 

23 samples, decontamination techniques, surveys, provision of bioassay samples, 

24 requested documentation). 

25 Reminders to RSO 

26  Supervise and confirm decontamination of personnel. If decontamination of personnel 

27 was not fully successful, consider inducing perspiration by covering the area with plastic. 

28 Then wash the affected area again to remove any contamination that was released by 

29 the perspiration. 

30  Document decontamination results, including all surveys, location of surveys, and 

31 decontamination results. 

32  Determine cause and needed corrective actions; consider need for bioassays if licensed 

33 material may have been ingested, inhaled, or absorbed through the skin. 

34  If necessary, notify the NRC. 
N–4 

1 Emergency Surgery of Patients Who Have Received Therapeutic Amounts of 

2 Radionuclides 

3 For emergency surgery or autopsy of patients administered byproduct material, National Council 

4 on Radiation Protection and Measurements (NCRP) Report No. 111, “Developing Radiation 

5 Emergency Plans for Academic, Medical, and Industrial Facilities,” 1991, may contain helpful 

6 information. 

7 If emergency surgery is performed within the first 24 hours following the administration of 

8 iodine-131 sodium iodide, fluids (e.g., blood, urine) will be carefully removed and contained in a 

9 closed system. 

10 Protective eyewear will be worn by the surgeon and any personnel involved in the surgical 

11 procedure for protection of the eyes from possible splashing of radioactive material and 

12 exposure from beta radiation (if applicable). 

13 The radiation safety staff will direct personnel in methods to keep doses as low as reasonable 

14 achievable (ALARA) during surgical procedures. 

15 If an injury occurs during surgery that results in a cut or tear in the glove used, the individual 

16 involved will be monitored to determine if radioactive material was introduced into the wound. 

17 The RSO will be informed of any possible radiation hazard. 

18 Autopsy of Patients Who Have Received Therapeutic Amounts of Radionuclides

19  Immediately notify the authorized user (AU) in charge of the patient and the RSO upon 

20 death of a therapy patient. 

21  An autopsy will be performed only after consultation and permission from the RSO. 

22 Radiation safety staff should evaluate the radiation hazard(s), direct personnel in safety 

23 and protection, and suggest suitable procedures in order to keep doses ALARA during 

24 the autopsy. 

25  Protective eyewear should be worn by the pathologist and assisting staff for protection 

26 from possible splashing of radioactive material. Consider the need for protection against 

27 exposure from high-energy beta rays in cases involving therapy with phosphorus-32 and 

28 yttrium-90. 

29  Remove tissues containing large activities early to help reduce exposure of autopsy 

30 personnel. Shield and dispose of contaminated tissues in accordance with license 

31 conditions. In some cases, exposure reduction may be accomplished by removing 

32 tissues for dissection to a location where the exposure rate is lower. 

33  If an injury occurs during the autopsy that results in a cut or tear in the glove, monitor the 

34 wound and decontaminate as appropriate to the situation; inform radiation safety staff. 

35 Autopsy or Cremation of Patients Who Have Permanent Implants 

36 Patients treated with seed implants will not usually represent a radiation hazard to persons 

37 dealing with the body unless there is to be an autopsy or cremation. For autopsy or cremation 
N–5 

1 of patients with permanent implants, NCRP Report No. 155, “Management of Radionuclide 

2 Therapy Patients,” December 2006, may contain helpful information. 

3 If an autopsy or cremation is to be performed 

4  Immediately notify the AU in charge of the patient and the RSO upon death of a therapy 

5 patient. 

6  Consult and get permission from the RSO. 

7  Instruct pathologist to excise tissue containing radioactive seeds. 

8 — Make pathologist aware seeds may have migrated and additional tissue may 

9 need to be removed. 

10 — Instruct pathologist to consult with RSO about possibility of slicing through a seed 

11 and contaminating the facility. 

12  Seek municipal approval, if required, because the very high temperatures used in 

13 modern crematoria may cause seeds to burst, releasing radioactivity into the plume. 

14 Nuclear Pacemakers 

15 Medical licensees are often the first to come into contact with plutonium-powered pacemakers 

16 or the first to be contacted by nursing homes and funeral homes when a patient with an 

17 implanted pacemaker dies. In such cases, and when the licensee is not responsible for control 

18 or disposal of the pacemaker, notify the NRC and attempt to contact the hospital where the 

19 pacemaker was implanted to arrange for explanation. The licensee that implanted the device is 

20 responsible for the follow-up, explanation, and return of the pacemaker to the manufacturer for 

21 proper disposal. Information Notice (IN) 98-12, “Licensees’ Responsibilities Regarding 

22 Reporting and Follow-up Requirements for Nuclear-Powered Pacemakers,” April 3, 1998, 

23 provides additional information. 

1 APPENDIX O 

2 MODEL PROCEDURES FOR ORDERING AND RECEIVING PACKAGES 

O–1 

1 Model Procedures for Ordering and Receiving Packages 

2 This model provides acceptable procedures for ordering and receiving packages containing 

3 licensed material. Applicants may either adopt this model or develop alternative procedures. 

4 Model Guidance 

5  Authorize, through a designee (e.g., radiation safety officer), each order of radioactive 

6 materials and ensure that the requested materials and quantities are authorized by the 

7 license for use by the requesting authorized user (AU) and that possession limits are not 

8 exceeded. 

9  Establish and maintain a system for ordering and receiving radioactive material; include 

10 the following information: 

11 — records that identify the AU or department, radionuclide, physical and/or 

12 chemical form, activity, and supplier 

13 — confirmation, through the above records, that material received was ordered 

14 through proper channels 

15  For deliveries during normal working hours, instruct carriers to deliver radioactive 

16 packages directly to a specified area and provide contact information to the carrier for 

17 any questions (e.g., delivery area not accessible, staff not present to receive package). 

18  For deliveries during off-duty hours, instruct security personnel or other designated 

19 persons to accept delivery of radioactive packages in accordance with procedures 

20 outlined in the sample memorandum for delivery of packages to the Nuclear Medicine 

21 Division, provided below. Develop a similar memorandum for delivery of packages to 

22 other divisions. 

 
O–2 

1 Sample Memorandum 

2 MEMO TO: Chief of Security 

3 FROM: Radiation Safety Officer 

4 SUBJECT: Receipt of Packages Containing Radioactive Material 

5 

6 The security guard on duty will accept delivery of radioactive material that arrives outside 

7 normal working hours. Packages will be taken immediately to the Nuclear Medicine 

8 Department, Room _____. Unlock the door, place the package _______________________, 

9 and relock the door. If the package appears to be damaged, immediately contact one of the 

10 individuals identified below. Ask the carrier to remain at the hospital until it can be determined 

11 that neither the driver nor the delivery vehicle is contaminated. 

12 

13 If you have any questions concerning this memorandum, please call our hospital Radiation 

14 Safety Officer, at extension _________. 

15 

16 NAME HOME TELEPHONE 

17 

18 Radiation Safety Officer _________________________________________ 

19 

20 Director of Nuclear Medicine _________________________________________ 

21 

22 Nuclear Medicine Technologist Supervisor _________________________________________ 

23 

24 Nuclear Medicine Technologist on call _________________________________________ 

25 (call/page operator at extension ___) 

26 Nuclear Medicine Physician on call _________________________________________ 

27 (call/page operator at extension ___) 
1 APPENDIX P 

2 MODEL PROCEDURES FOR SAFELY OPENING PACKAGES CONTAINING 

3 RADIOACTIVE MATERIAL 

P–1 

1 Model Procedures for Safely Opening Packages Containing 

2 Radioactive Material 

3 This model provides acceptable procedures for opening packages containing radioactive 

4 material. Applicants may either adopt this model procedure or develop an alternative procedure 

5 to meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 20.1906. 

6 Special requirements must be followed for packages containing quantities of radioactive 

7 material in excess of the Type A quantity limits specified in Table A–1 in Appendix A of 

8 10 CFR Part 71. Such packages must be received expeditiously when the carrier offers them 

9 for delivery or when the carrier notifies the licensee that the package has arrived at the carrier’s 

10 terminal. For these and other packages for which monitoring is required, check for external 

11 radiation levels and surface contamination within 3 hours of receipt, if received during working 

12 hours, or no later than 3 hours from the beginning of the next working day, if received after 

13 working hours, in accordance with the requirements of 10 CFR 20.1906(c). Notify the final 

14 delivery carrier and the U.S. Nuclear Regulatory Commission (NRC) Operations Center, (301) 

15 816-5100, by telephone, when 

16  removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i)

17  external radiation levels exceed the limits of 10 CFR 71.47

18 Model Procedure 

19 1. Put on gloves to prevent hand contamination. 

20 2. Visually inspect the package for any sign of damage (e.g., wet or crushed). If damage is 

21 noted, stop the procedure and immediately notify the radiation safety officer (RSO) or 

22 the designee of the RSO, if the RSO is not present. 

3. Monitor the external surfaces of a labeled1 23 package for radioactive contamination, unless 

24 the package contains only radioactive material in the form of a gas or in special form, as 

25 defined in 10 CFR 71.4, “Definitions.” 

26 4. Monitor the external surfaces of a labeled package for radiation levels, unless the 

27 package contains quantities of radioactive material that are less than or equal to the 

28 Type A quantity, as defined in 10 CFR 71.4 and Table A–1 in Appendix A of 

29 10 CFR Part 71. Monitor all packages known to contain radioactive material for 

30 radioactive contamination and radiation levels, if there is evidence of degradation of 

31 package integrity, such as packages that are crushed, wet, or damaged. 

32 5. Remove the packing slip. 

33 6. Open the outer package, following any instructions that may be provided by the supplier. 

34 7. Open the inner package and verify that the contents agree with the packing slip. 

 

1

Labeled with a Radioactive White I, Yellow II, or Yellow III label as specified in DOT regulations. 
P–2 

1 8. Check the integrity of the final source container. Notify the RSO or the RSO’s designee 

2 of any broken seals or vials, loss of liquid, condensation, or discoloration of the packing 

3 material. 

4 9. If there is any reason to suspect contamination, wipe the external surface of the final 

5 source container and remove the wipe sample to a low-background area. Assay the 

6 wipe sample to determine if there is any removable radioactivity. Use an appropriate 

7 instrument with sufficient sensitivity to assay the sample. For example, a sodium iodide 

8 crystal and rate meter, a liquid scintillation counter, or a proportional flow counter may be 

9 used for these assays. Convert wipe sample from counts per minute to disintegrations 

10 per minute. 

11 Note: A dose calibrator is not sufficiently sensitive for this measurement. Take 

12 precautions against the potential spread of contamination. 

13 10. Check the user request to ensure that the material received is the material that was 

14 ordered. 

15 11. Monitor the packing material and the empty packages for contamination with a radiation 

16 survey meter before discarding. If contaminated, treat this material as radioactive waste. 

17 If not contaminated, remove or obliterate the radiation labels before discarding. 

18 12. Make a record of the receipt. 

19 For packages received under the general license in 10 CFR 31.11, implement the following 

20 procedure for opening each package: 

21 1. Visually inspect the package for any sign of damage (e.g., wet or crushed). If damage is 

22 noted, stop the procedure and notify the RSO or the RSO’s designee immediately. 

23 2. Check to ensure that the material received is the material that was ordered. 
1 APPENDIX Q 

2 MODEL LEAK TEST PROGRAM 

Q–1 

1 Model Leak Test Program 

2 This model program provides acceptable procedures for sealed source leak testing and 

3 analysis. Applicants may either adopt these model procedures or develop alternative 

4 procedures. 

5 Training

6 Before allowing an individual to perform leak testing, the licensee must ensure that he or she 

7 has sufficient classroom and on-the-job training to show competency in performing leak testing 

8 and sample analysis independently in accordance with Title 10 of the Code of Federal 

9 Regulations (10 CFR) 30.33(a)(3). Records for training on the applicable leak test procedures 

10 should be maintained. See Appendix X of this NUREG for recordkeeping requirements. 

11 Classroom training may be in the form of lecture, online, video, or self-study, and should cover 

12 the following subject areas: 

13  principles and practices of radiation protection 

14  radioactivity measurements, monitoring techniques, and using instruments 

15  mathematics and calculations used for measuring radioactivity 

16  biological effects of radiation 

17 Appropriate on-the-job training consists of the following: 

18  observing authorized personnel collecting and analyzing leak test samples 

19  collecting and analyzing leak test samples under the supervision and in the physical 

20 presence of an individual authorized to perform leak test and sample analysis 

21 Facilities and Equipment 

22  To ensure the required sensitivity of measurements is achieved, analyze leak tests in a 

23 low background area. 

24  Use a calibrated and operable survey instrument to check leak test samples for gross 

25 contamination before they are analyzed. 

26  Analyze the leak test sample using an instrument that is appropriate for the type of 

27 radiation to be measured (e.g., sodium iodide well-counter system for gamma emitters, 

28 liquid scintillation detector for beta emitters, or gas-flow proportional counters for alpha 

29 emitters). 

30  Instrumentation used to analyze leak test samples must be capable of detecting 185 

31 becquerels (Bq) [0.005 microcuries (μCi)] of radioactivity. 

32 

33 

34 
Q–2 

1  If the sensitivity of the counting system is unknown, determine the minimum detectable 

2 activity (MDA). The MDA may be determined using the following formula: 

3 MDA = 2.71 + 4.65 √(bkg × t) 

4 t × E

5 where: MDA = minimum detectable activity in disintegrations per minute (dpm) 

6 bkg = background count rate in counts per minute (cpm) 

7 t = background counting time in minutes 

8 E = detector efficiency in counts per disintegration

9 For example: 

10 where: bkg = 200 cpm 

11 E = 0.1 counts per disintegration (10% efficient) 

12 t = 2 minutes 

13 MDA = 2.71 + 4.65 √(200 cpm × 2 minutes) = 2.71 + 4.65√(400) 

14 2 × 0.1 0.2 

15 = 2.71 + 4.65 (20) = 2.71 + 93 = 95.71 

16 0.2 0.2 0.2 

17 = 478.55 disintegrations 

18 minute 

19 Bq = 1 disintegration 

20 second 

21 Bq = 478.55 disintegration × minute = 7.976 Bq 

22 minutes 60 seconds 

23 Note: The MDA equation shown assumes that counting times for the background 

24 measurement and for the sample will be equal. MDA equations for nonequal counting times, 

25 as well as derivations of equations and discussions of limitations, can be found in 

26 “Decommissioning Health Physics—A Handbook for MARSSIM Users,” Eric W. Abelquist, 

27 published by Taylor & Francis Group, 2001. 

28 Reference: 

29  National Council on Radiation Protection and Measurements (NCRP) Report No. 58, “A 

30 Handbook of Radioactivity Measurement Procedures,” Second Edition, 1985. 

31 
Q–3 

1 Frequency for Conducting Leak Tests of Sealed Sources 

2 Leak tests will be conducted at the frequency specified in the respective Sealed Source and 

3 Device registration certificate. If a sealed source is not registered, leak tests should be 

4 conducted at 6 month intervals, unless a different interval is established during the licensing 

5 process. Leak testing of sealed sources may be required by license condition. 

6 

7 Procedure for Performing Leak Testing and Analysis [on all sealed sources 

8 except individual radium-226 (Ra-226) sealed sources] 

9  Follow the manufacturer’s instructions for performing the leak test. 

10  For each sealed source to be tested, list identifying information such as sealed source 

11 serial number, manufacturer, model number, radionuclide, and activity. 

12  Use a radiation survey meter to monitor exposure. 

13  Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source. 

14  Number each wipe to correlate identifying information for each source. 

15  Wear gloves. 

16  Wipe the most accessible area where contamination would accumulate if the sealed 

17 source were leaking, but do not wipe the surface of a plated or foil source (see 

18 manufacturer’s instructions). 

19 Procedure for Performing Gaseous Emanation Test for Individual Ra-226 Sealed 

20 Sources (ANSI/HPS N43.6-1997, “Sealed Radioactive Sources - Classification,” 

21 Appendix A, Section A.2.1.5) 

22  For each source to be tested, list identifying information such as sealed source serial 

23 number, manufacturer, model number, radionuclide, and activity. 

24  Number each container to correlate information for each source. 

25  Wear gloves. 

26  Put each Ra-226 sealed source into a separate small, gas-tight container with activated 

27 carbon or two cotton filters. 

28 — Leave source in airtight container for 24 hours. 

29 — Remove source. 

30 — Close container. 

31  Measure immediately the activity of the Absorber. (See “Model Procedure for Analysis 

32 of Gaseous Emanation and Leak Test” below for (i) how to analyze the absorber, (ii) 
Q–4 

1 required records, (iii) leakage determination, and (iii) required response to a leaking 

2 source.) 

3  If the wipe test reveals 37 Bq [1 nano curie (Ci)] or greater of radon or daughter products 

4 — Notify the RSO. 

5 — Immediately withdraw the sealed source from use and store it, dispose of it, or 

6 cause it to be repaired in accordance with the requirements in 10 CFR Parts 20 

7 and 30 [10 CFR 35.67 or standard license condition]. 

8 — File a report within 5 days of the leak test, in accordance with 10 CFR 35.3067, 

9 “Report of a leaking source,” or standard license condition. 

10 Procedure for Analysis of Leak Test and Gaseous Emanation 

11  Select an instrument that is sensitive enough to detect 185 Bq [0.005 μCi] of the 

12 radionuclide and ensure that its calibration is current. 

13  Using the selected instrument, count and record background count rate. 

14  Check the instrument’s counting efficiency using a standard source of the same 

15 radionuclide as the source being tested or one with similar energy characteristics. The 

16 calibration source should be in the same configuration as the sample. Accuracy of 

17 standards should be within ± 5% of the stated value and traceable to a primary radiation 

18 standard, such as those maintained by the National Institute of Standards and 

19 Technology. 

20  Calculate efficiency of the instrument. 

21 

22 For example:

ሻሿܾ݇݃	݉݋ݎ݂	݉݌ܿሺ െ ሻ݀ݐݏ	݉݋ݎ݂	݉݌ܿሾሺ 	ൌ ݂݂ܧ

		 ሻݍܤ	݅݊	݀ݐݏ	݂݋	ݕݐ݅ݒ݅ݐܽܿሺ

23 where: 

24 Eff = efficiency, in cpm/Bq

25 cpm = counts per minute 

26 std = standard 

27 bkg = background 

28 Bq = becquerel 

29  Count each wipe (or absorber for a Ra-226 sealed source) sample; determine net count 

30 rate. 

31  For each sample, calculate and record activity in Bq (or μCi). 

32 The activity of the sample in becquerels may be calculated using the following formula: 

33 

Activity	on	wipe	sample	ሾBqሿ ൌ 	 ሾሺ௖௣௠	୤୰୭୫	୵୧୮ୣ	ୱୟ୫୮୪ୣሻି	ሺ௖௣௠	୤୰୭୫	௕௞௚ሻሿ

ቀா௙௙	୧୬೎೛೘

ಳ೜ ቁ 34 
Q–5 

1  Leak test records (which include the gaseous emanation test) will be retained in 

2 accordance with 10 CFR 35.2067, “Records of leak tests and inventory of sealed 

3 sources and brachytherapy sources,” or standard license condition for 3 years. 

4 Licensees should include the following in records: 

5 — the model number and serial number (if assigned) of each source tested 

6 — the identity of each source radionuclide and its estimated activity 

7 — the measured activity of each test sample expressed in μCi 

8 — a description of the method used to measure each test sample 

9 — the date of the test 

10 — the name of the individual who performed the test 

11  If the wipe test reveals 185 Bq [0.005 μCi] [or 37 Bq [1 nano Ci] of radon or daughter 

12 products] or greater: 

13 — Notify the RSO. 

14 — Immediately withdraw the sealed source from use and store it, dispose of it, or 

15 cause it to be repaired in accordance with the requirements in 10 CFR Parts 20 

16 and 30 [10 CFR 35.67 or standard license condition]. 

17 — File a report within 5 days of the leak test, in accordance with 10 CFR 35.3067, 

18 “Report of a leaking source,” or standard license condition. 

1 APPENDIX R 

2 MODEL PROCEDURES FOR AREA SURVEY 

R–1 

1 Model Procedures for Area Survey 

2 This model provides acceptable methods for area surveys. Applicants may either adopt these 

3 model procedures or develop alternative procedures to meet the requirements of Title 10 of the 

4 Code of Federal Regulations (10 CFR) 20.1101, 10 CFR 20.1501, and 10 CFR 35.70, “Surveys 

5 of ambient radiation exposure rate.” Guidance for developing alternate trigger levels for 

6 contamination in restricted areas is included below. Before use of survey instrumentation, 

7 perform a daily check with a dedicated check source and battery checks. 

8 Ambient Radiation Level Surveys 

9 Procedures for ambient radiation level surveys (reference 10 CFR 20.1101, 10 CFR 20.1501, 

10 and 10 CFR 35.70): 

11  Perform surveys of dose rates in locations where 

12 — Workers are exposed to radiation levels that might result in radiation doses in 

13 excess of 10% of the occupational dose limits or 

14 — An individual is working in an environment with a dose rate of 0.0025 millisievert 

15 (mSv)/h [2.5 millirem/hour (h)] or more [5 rem/year (yr) divided by 2,000 h/yr]. 

16  Regulations in 10 CFR 20.1301 requires that the total effective dose equivalent to an 

17 individual member of the public from the licensed operation does not exceed 1 

18 millisievert (mSv) [0.1 rem] in a year, and that the dose in any unrestricted area from 

19 external sources does not exceed 0.02 mSv [0.002 rem] in any one hour. Appropriate 

20 surveys will be conducted to ensure that the requirements of 10 CFR 20.1301 are met. 

21  Perform radiation level surveys with a radiation survey meter sufficiently sensitive to 

22 detect 0.1 milliroentgen (mR)/h in the following areas, at the frequency specified: 

23 — Survey at the end of each day of use all radiopharmaceutical elution, preparation, 

24 assay and administration areas (except patient rooms, which will be surveyed at 

25 the end of the therapy instead of on the day of administration) when using 

26 radiopharmaceuticals requiring a written directive [e.g., all therapy dosages and 

27 any iodine 131 (I-131) dosage exceeding 30 microcuries (μCi)]. 

28 — Survey monthly all laboratory areas where only small quantities of 

29 gamma-emitting radioactive material are used (less than 200 μCi at a time). 

30 — Survey weekly all radionuclide use, storage, and waste storage areas. If 

31 diagnostic administrations are occasionally made in patients’ rooms [e.g., bone 

32 scan injections, technetium 99m (Tc-99m) heart agents] and special care is taken 

33 to remove all paraphernalia, those rooms need not be surveyed. 

34  If trigger levels are exceeded, follow internal procedures for responding and investigating 

35 what caused the trigger to be tripped. Examples of trigger levels for restricted and 

36 unrestricted areas are presented in Table R–1. 
R–2 

Table R–1. Ambient Dose Rate Trigger Levels 

Type of Survey Area Surveyed Trigger Level

Ambient Dose Rate Unrestricted 0.1 mR/h 

Ambient Dose Rate Restricted 5.0 mR/h 

1 Contamination Surveys 

2 Facilities and equipment for contamination surveys: 

3 To ensure achieving the required sensitivity of measurements, analyze survey samples in a 

4 low-background area. The section of Table K–1, entitled “Stationary Instruments Used to 

5 Measure Wipe, Bioassay, and Effluent Samples,” provides examples of appropriate instruments. 

6 Perform contamination surveys using instruments suitable for removable and fixed 

7 contamination to identify areas of contamination that might result in doses to workers or to the 

8 public. Removable contamination can be detected and measured by conducting a wipe test of 

9 the surface, counted in an appropriate counting instrument, such as a liquid scintillation counter, 

10 a sodium iodide or germanium gamma counter, or a proportional alpha/beta counter. 

11 Procedures for contamination surveys: 

12  Contamination surveys are performed in areas where unsealed forms of byproduct 

13 materials are used: 

14 — to evaluate radioactive contamination that could be present on surfaces of floors, 

15 walls, laboratory furniture, and equipment 

16 — after any spill or contamination event 

17 — when procedures or processes have changed 

18 — to evaluate contamination of users and the immediate work area, at the end of 

19 the day, when licensed material is used 

20 — in unrestricted areas at frequencies consistent with the types and quantities of 

21 materials in use, but not less frequently than monthly 

22 — in areas adjacent to restricted areas and in all areas through which licensed 

23 materials are transferred and temporarily stored before shipment 

24  Use methods for conducting surveys for removable contamination that are sufficiently 

25 sensitive to detect contamination for those radionuclides in use and for which the most 

26 restrictive limits apply, as listed in Tables R–2 for restricted areas and R–3 for 

27 unrestricted areas [e.g., 200 disintegrations per minute (dpm)/100 square centimeters 

(cm2 28 ) for isotopes of I-131 in unrestricted areas]. Table R–3 for unrestricted areas is 

29 based on Regulatory Guide (RG) 1.86, “Termination of Operating Licenses for Nuclear 

30 
R–3 

1 Reactors.” Removable contamination survey samples should be measured in a 

2 low-background area. The following areas and frequencies should be followed: 

3 — Removable contamination surveys weekly for radiopharmaceutical elution, 

4 preparation, assay, and administration areas. If diagnostic administrations are 

5 occasionally made in patients’ rooms (e.g., bone scan injections, Tc-99m heart 

6 agents), with special care taken to remove all paraphernalia, those rooms need 

7 not be surveyed. 

8 — Removable contamination surveys monthly of laboratory areas where only small 

9 quantities of photon-emitting radioactive material are used (less than 200 μCi at a 

10 time). 

11 — Removable contamination surveys weekly for radionuclide storage and 

12 radionuclide waste storage areas. 

13  A radioactive source with a known amount of activity should be used to convert sample 

14 measurements (usually in counts per minute) to dpm. 

15  The area should be either decontaminated, shielded, or posted and restricted from use if 

16 it cannot be decontaminated. 

17  If trigger levels are exceeded, follow internal procedures for responding and investigating 

18 what caused the trigger to be tripped. Examples of trigger levels for restricted areas are 

19 presented in Table R–2. Contamination found in unrestricted areas and on personal 

20 clothing will be immediately decontaminated to background levels. 

Table R–2. Surface Contamination Levels in Restricted Areas (dpm/100 cm2

) 

Area, clothing Restricted areas, protective clothing used only in 

restricted area 

alpha emitters 200 

P-32, Co-58, Fe-59, Co-60, Se-75, 

Sr-85, Y-90, In-111, I-123, I-125, I-131, 

Sm-153, Yb-169, Lu-177, Au-198 

2000 

Cr-51, Co-57, Ga-67, Tc-99m, Hg-197, 

Tl-201 

20000 

 
R–4 

Table R–3. Surface Contamination Levels in Unrestricted Areas (dpm/100 cm2

) 

Nuclide* Average†, ‡, § Maximum†, ║, § Removable†, ¶, §

I-123, I-125, I-129, Ra-223, Ra-224, 

Ra-226 

100 300 20 

I-126, I-131, I-133, Sr-90 1000 3000 200 

Beta-gamma emitters (nuclides with 

decay modes other than alpha 

emission or spontaneous fission) 

except those noted above. 

5000 15000 1000 

*Where surface contamination by multiple nuclides exists, the limits established for each nuclide should apply 

independently. 

†

As used in this table, 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. 

‡

Measurements of average contaminants 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. 

§

The average and maximum radiation levels associated with surface contamination resulting from beta-gamma 

emitters should not exceed 0.2 millirad/h at 1 cm and 1.0 millirad/h at 1 centimeter, respectively, measured 

through not more than 7 milligram/cm2

 of total absorber.

║The maximum contamination level applies to an area of not more than 100 cm2

. 

¶The amount of removable radioactive material per 100 cm2

 of surface area should be determined by swiping that 

area with 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 Establishing Alternate Trigger Levels for Restricted Areas 

2 The following guidance is provided for those applicants who plan to develop procedures for 

3 surveying and controlling contamination using action levels for controlling contamination that 

4 differ from those provided in Tables R–1 and R–2: 

5 

6 Alternate action levels for cleanup of contamination in restricted areas may be developed 

7 without prior NRC approval if 

8  acceptable unrestricted area trigger levels are implemented (e.g., Tables R–1 and R–3) 

9  the action levels maintain occupational doses as low as is reasonably achievable 

10  the action levels meet all other regulatory requirements (e.g., they should also be 

11 designed to minimize, to the extent practicable, contamination of the facility and the 

12 environment; facilitate eventual decommissioning; and minimize, to the extent 

13 practicable, the generation of radioactive waste) 
R–5 

1 Contents of Survey Records 

2  a diagram of the area surveyed 

3  a list of items and equipment surveyed 

4  specific locations on the survey diagram where wipe tests were taken 

5  ambient radiation levels with appropriate units 

6  contamination levels with appropriate units 

7  make and model number of instruments used 

8  background levels 

9  name of the person making the evaluation and recording the results and date 

10 Record contamination levels observed and procedures followed for incidents involving 

11 contamination of individuals. Include names of individuals involved, description of work 

12 activities, calculated dose, probable causes (including root causes), steps taken to reduce future 

13 incidents of contamination, times and dates, and the surveyor’s signature. 

1 APPENDIX S 

2 MODEL PROCEDURES FOR DEVELOPING, MAINTAINING, AND 

3 IMPLEMENTING WRITTEN DIRECTIVES 

S–1 

1 Model Procedures for Developing, Maintaining, and Implementing 

2 Written Directives 

3 This model provides acceptable procedures for administrations that require written directives 

4 (WD). Applicants may either adopt this model procedure or develop their own procedure to 

5 meet the requirements of Title 10 of the Code of Federal Regulations (10 CFR) 35.40. 

6 Written Directive Procedures 

7 This model provides guidance to licensees and applicants for developing, maintaining, and 

8 implementing procedures for administrations that require WDs. This model does not restrict the 

9 use of other guidance in developing, implementing, and maintaining written procedures for 

10 administrations requiring a WD. Such procedures are to provide high confidence that the 

11 objectives specified in 10 CFR 35.41 will be met. 

12 The WD must be prepared for any administration of I-131 sodium iodide greater than 1.11 

13 megabecquerels [30 microcuries], any therapeutic dosage of a radiopharmaceutical, and any 

14 therapeutic dose of radiation from byproduct material. The WD must contain the information 

15 described in 10 CFR 35.40 and be retained in accordance with 10 CFR 35.2040, “Records of 

16 written directives.” 

17 Discussion 

18 The administration of radioactive materials can be a complex process for many types of 

19 diagnostic and therapeutic procedures in nuclear medicine or radiation oncology departments. 

20 A number of individuals may be involved in the delivery process. For example, in an oncology 

21 department, when the authorized user (AU) prescribes a high dosage-rate treatment, the 

22 delivery process may involve a team of medical professionals, such as an authorized medical 

23 physicist (AMP), a dosimetrist, and a radiation therapist. Treatment planning may involve a 

24 number of measurements, calculations, computer-generated treatment plans, patient 

25 simulations, and film verifications to deliver the prescribed dose. Therefore, instructions must 

26 be clearly communicated to the professional team members with constant attention devoted to 

27 detail during the treatment process. Complicated processes of this nature require good 

28 planning and clear, understandable procedures. To help ensure that all personnel involved in 

29 the treatment fully understand instructions in the WD or treatment plan, the licensee should 

30 instruct all workers to seek guidance if they do not understand how to carry out the WD. 

31 Specifically, workers should ask if they have any questions about what to do or how it should be 

32 completed before administration, rather than continuing a procedure when there is any doubt. 

33 Licensees should also consider verification of WDs or treatment plans by at least one qualified 

34 person (e.g., an oncology physician, AMP, nuclear medicine technologist, or radiation therapist), 

35 preferably other than the individual who prepared the dose, the dosage, or the treatment plan. 

36 The administration of radioactive materials can involve a number of treatment modalities 

37 (e.g., radiopharmaceutical therapy, teletherapy, brachytherapy, gamma stereotactic 

38 radiosurgery (GSR), and future emerging technologies). For each such modality for which 

39 10 CFR 35.40 requires, or would require, a WD (as defined in 10 CFR 35.2, “Definitions”), the 

40 
S–2 

1 licensee should develop, implement, and maintain written procedures to meet the requirements 

2 and objectives of 10 CFR 35.40, 35.41, and 35.63, outlined below: 

3  Confirm that the WD is signed and dated by the AU prior to the administration, in 

4 accordance with 10 CFR 35.40(b), including the name of the patient or human research 

5 subject. 

6  Verify the identity of the patient or human research subject prior to each administration. 

7  Verify that the administration is in accordance with the treatment plan, if applicable, and 

8 the WD. 

9  Check both manual and computer-generated dose calculations. 

10  Verify that any computer-generated dose calculations are correctly transferred into the 

11 consoles of therapeutic medical devices. 

12  Determine and record the activity of the radiopharmaceutical dosage or radiation dose 

13 before medical use. 

14 The following procedures are provided as assistance in meeting the above objectives. 

15 Procedures for Any Therapeutic Dose or Dosage of a Radionuclide or Any Dosage of Quantities 

16 Greater than 30 Microcuries of Iodine-131 Sodium Iodide 

17 Develop, implement, and maintain the following procedures to meet the objectives of 

18 10 CFR 35.40 and 10 CFR 35.41: 

19  An AU must date and sign a WD prior to the administration of any dose or dosage. WDs 

20 may be maintained in patients’ charts. 

21  Prior to administering a dose or dosage, the identity of a patient or human research 

22 subject will be positively verified as the individual named in the WD. Examples of 

23 positive patient identity verification include examining the patient’s ID bracelet, hospital 

24 ID card, driver’s license, or Social Security card. Asking or calling the patient’s name 

25 does not constitute positive patient identity verification. 

26  The specific details of the administration will be verified, including the dose or dosage, in 

27 accordance with the WD or treatment plan. All components of the WD (e.g., 

28 radionuclide, total dose or dosage) will be confirmed by the person administering the 

29 dose or dosage to verify agreement with the WD. Appropriate verification methods 

30 include (i) measuring the activity in the dose calibrator, (ii) checking the serial number of 

31 the sealed sources behind an appropriate shield, (iii) using color-coded sealed sources, 

32 or (iv) using clearly marked storage locations. 

33 Procedures for Sealed Therapeutic Sources and Devices Containing Sealed 

34 Therapeutic Sources 

35 Licensees are required under 10 CFR 35.40 and 10 CFR 35.41 to have WDs for certain 

36 administrations of doses and to have procedures for administrations for which a WD is required. 

37 Model procedures for meeting these requirements appear below. 
S–3 

1 To ensure that the dose is delivered in accordance with the WD, the AU (and the neurosurgeon 

2 for GSR therapy) must date and sign the treatment plan, indicating approval. The treatment 

3 plan should provide sufficient information and direction to meet the objectives of the WD. 

4 For sealed sources inserted into the patient’s body, radiographs or other comparable images 

5 (e.g., computerized tomography) will be used as the basis for verifying the position of the 

6 nonradioactive dummy sources and calculating the administered dose before administration. 

7 However, for some brachytherapy procedures, the use of various fixed geometry applicators 

8 (e.g., appliances or templates) may be required to establish the location of the temporary 

9 sources and to calculate the exposure time (or, equivalently, the total dose) required to 

10 administer the prescribed brachytherapy treatment. In these cases, radiographs or other 

11 comparable images may not be necessary, provided the position of the sources is known prior 

12 to insertion of the radioactive sources and calculation of the exposure time (or, equivalently, the 

13 total dose). 

14 Dose calculations will be checked before administering the prescribed therapy dose. An AU or 

15 a qualified person under the supervision of an AU (e.g., an AMP, oncology physician, 

16 dosimetrist, or radiation therapist), preferably an individual who did not make the original 

17 calculations, will check the dose calculations. Methods for checking the calculations include the 

18 following: 

19 1. for computer-generated dose calculations, examining the computer printout to verify that 

20 correct input data for the patient was used in the calculations (e.g., source strength and 

21 positions) 

22 2. for computer-generated dose calculations entered into the therapy console, verifying 

23 correct transfer of data from the computer (e.g., channel numbers, source positions, and 

24 treatment times) 

25 3. for manually-generated dose calculations, verifying 

26 a. no arithmetical errors 

27 b. appropriate transfer of data from the WD, treatment plan, tables, and graphs 

28 c. appropriate use of nomograms (when applicable) 

29 d. appropriate use of all pertinent data in the calculations 

30 The therapy dose will be manually calculated to a single key point and the results compared to 

31 the computer-generated dose calculations. If the manual dose calculations are performed using 

32 computer-generated outputs (or vice versa), verify the correct output from one type of 

33 calculation (e.g., computer) to be used as an input in another type of calculation (e.g., manual). 

34 Parameters such as the transmission factors for wedges and applicators and the source 

35 strength of the sealed source used in the dose calculations will be checked. 

36 After implantation but before completion of the procedure, record in the WD the radionuclide, 

37 treatment site, number of sources, and total source strength and exposure time (or the total 

38 dose), as required by 10 CFR 35.40(b)(6). For example, after insertion of permanent implant 

39 brachytherapy sources, an AU should promptly record the actual number of radioactive sources 

40 implanted and the total source strength. The WD may be maintained in the patient’s chart. 

41 Acceptance testing will be performed by a qualified person (e.g., an AMP) on each treatment 

42 planning or dose calculating computer program that could be used for dose calculations. 
S–4 

1 Acceptance testing will be performed before the first use of a treatment planning or dose 

2 calculating computer program for therapy dose calculations. Each treatment planning or dose 

3 calculating computer program will be assessed based on specific needs and applications. A 

4 check of the acceptance testing will also be performed after each source replacement or when 

5 spot check measurements indicate that the source output differs by more than 5% from the 

6 output obtained at the last full calibration corrected mathematically for radioactive decay. 

7 Independent checks on full calibration measurements will be performed. The independent 

8 check will include an output measurement for a single specified set of exposure conditions and 

9 will be performed within 30 days following the full calibration measurements. The independent 

10 check will be performed by either 

11 1. an individual who did not perform the full calibration (the individual will meet the 

12 requirements specified in 10 CFR 35.51) using a dosimetry system other than the one 

13 that was used during the full calibration (the dosimetry system will meet the 

14 requirements specified in 10 CFR 35.630) 

15 2. an AMP (or an oncology physician, dosimetrist, or radiation therapist who has been 

16 properly instructed) using a thermoluminescence dosimetry service available by mail that 

17 is designed for confirming therapy doses and that is accurate within 5% 

18 For GSR, particular emphasis will be directed on verifying that the stereoscopic frame 

19 coordinates on the patient’s skull match those of the treatment plan. 

20 For emerging technologies (e.g., Yttrium-90 Microsphere Brachytherapy, Leksell Gamma Knife 

21 Perfextion), the licensee should review the applicable guidance on the Medical Uses Licensee 

22 Toolkit to ensure the written directive contains all necessary components. 

23 A physical measurement of the teletherapy output will be made under applicable conditions prior 

24 to administration of the first teletherapy fractional dose, if the patient’s treatment plan includes 

25 (i) field sizes or treatment distances that fall outside the range of those measured in the most 

26 recent full calibration; or (ii) transmission factors for beam-modifying devices (except 

27 nonrecastable and recastable blocks, bolus and compensator materials, and split-beam 

28 blocking devices) not measured in the most recent full calibration measurement. 

29 A weekly chart check will be performed by a qualified person under the supervision of an AU 

30 (e.g., an AMP, dosimetrist, oncology physician, or radiation therapist) to detect mistakes 

31 (e.g., arithmetical errors, miscalculations, or incorrect transfer of data) that may have occurred 

32 in the daily and cumulative dose administrations from all treatment fields or in connection with 

33 any changes in the WD or treatment plan. 

34 Treatment planning computer systems using removable media to store each patient’s treatment 

35 parameters for direct transfer to the treatment system will have each card labeled with the 

36 corresponding patient’s name and identification number. Such media may be reused and must 

37 be relabeled in accordance with the manufacturer’s instructions. 

38 Review of Administrations Requiring a Written Directive 

39 Conduct periodic reviews of each applicable program area (e.g., radiopharmaceutical therapy, 

40 high dose-rate brachytherapy, implant brachytherapy, teletherapy, and emerging technologies). 

41 The number of patient cases to be sampled should be based on the principles of statistical 
S–5 

1 acceptance sampling and be representative of each treatment modality performed in 

2 the institution. 

3 If feasible, the persons conducting the review should not review their own work. If this is not 

4 possible, two people should work together as a team to conduct the review of that work. 

5 Regularly review the findings of the periodic reviews to ensure that the procedures for 

6 administrations requiring a WD are effective. 

7 As required by 10 CFR 35.41, a determination will be made as to whether the administered 

8 radiopharmaceutical dosage or radiation dose was in accordance with the WD or treatment 

9 plan, as applicable. When deviations from the WD are found, the cause of each deviation and 

10 the action required to prevent recurrence should be identified.

11 Reports of Medical Events 

12 Notify by telephone the U.S. Nuclear Regulatory Commission (NRC) Operations Center at 

13 301-816-5100 no later than the next calendar day after discovery of a medical event and submit 

14 a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6, 

15 “Communications,” within 15 days after the discovery of the medical event, as required by 

16 10 CFR 35.3045, “Report and notification of a medical event.” Also notify the referring physician 

17 and the patient as required by 10 CFR 35.3045. 

1 APPENDIX T 

2 MODEL PROCEDURES FOR SAFE USE OF UNSEALED LICENSED 

3 MATERIAL 

T–1 

1 Model Procedures for Safe Use of Unsealed Licensed Material 

This model1 2 provides acceptable procedures for safe use of unsealed licensed material. 

3 Applicants may either adopt this model procedure or develop their own procedure. Some of the 

4 health physics practices listed below may also apply to sealed sources. 

5  Wear laboratory coats or other protective clothing at all times in areas where radioactive 

6 materials are used. 

7  Wear disposable gloves at all times while handling radioactive materials. 

8  Either after each procedure or before leaving the area, monitor hands for contamination 

9 in a low-background area using an appropriate survey instrument. 

10  Use syringe shields for reconstitution of radiopharmaceutical kits and administration of 

11 radiopharmaceuticals to patients, except when their use is contraindicated 

12 (e.g., recessed veins, infants). In these and other exceptional cases, use other 

13 protective methods, such as remote delivery of the dose (e.g., use a butterfly needle). 

14  Do not eat, store food, drink, smoke, or apply cosmetics in any area where licensed 

15 material is stored or used. 

16  Wear personnel monitoring devices, if required, at all times while in areas where 

17 radioactive materials are used or stored. These devices shall be worn as prescribed by 

18 the radiation safety officer. When not being worn to monitor occupational exposures, 

19 personnel monitoring devices shall be stored in the work place in a designated 

20 low-background area. 

21  Wear extremity dosimeters, if required, when handling radioactive material. 

22  Dispose of radioactive waste only in designated, labeled, and properly shielded 

23 receptacles. 

24  Never pipette by mouth. 

25  Wipe-test unsealed byproduct material storage, preparation, and administration areas 

26 weekly for contamination. If necessary, decontaminate the area. 

27  Survey all areas of licensed material use, including the generator storage, kit 

28 preparation, and injection areas, for contamination using a survey instrument each day 

29 of use. If necessary, decontaminate the area. Areas used to prepare and administer 

30 therapy quantities of radiopharmaceuticals must be surveyed daily in accordance with 

31 Title 10 of the Code of Federal Regulations (10 CFR) 35.70 (except when administering 

32 therapy dosages in patients’ rooms when patients are confined). 

33  Store radioactive solutions in shielded containers that are clearly labeled. 

 

1

NCRP Report No. 30, “Safe Handling of Radioactive Materials,” March 1964. 
T–2 

1  Radiopharmaceutical multi-dose diagnostic and therapy vials must be labeled in 

2 accordance with 10 CFR 35.69, “Labeling of vials and syringes,” and 10 CFR 20.1904, 

3 “Labeling containers.” 

4  Syringes and unit dosages must be labeled in accordance with 10 CFR 35.69 and 

5 10 CFR 20.1904. Mark the label with the radionuclide, the activity, the date for which the 

6 activity is estimated, and the kind of materials (i.e., radiopharmaceutical). If the 

7 container is holding less than the quantities listed in Appendix C to 10 CFR Part 20, 

8 “Quantities of Licensed Material Requiring Labeling,” the syringe or vial need only be 

9 labeled to identify the radioactive drug (10 CFR 35.69). To avoid mistaking patient 

10 dosages, label the syringe with the type of study and the patient’s name. 

11  For prepared dosages, assay each patient dosage in the dose calibrator (or instrument) 

12 before administering it (10 CFR 35.63). 

13  Do not use a dosage if it does not fall within the prescribed dosage range or if it varies 

14 more than ±20% from the prescribed dosage, except as approved by an authorized user. 

15  When measuring the dosage, licensees need not consider the radioactivity that adheres 

16 to the syringe wall or remains in the needle. 

17  Check the patient’s name and identification number and the prescribed radionuclide, 

18 chemical form, and dosage before administering. If the prescribed dosage requires a 

19 written directive (WD), the patient’s identity must be verified and the administration must 

20 be in accordance with the WD (10 CFR 35.41). 

21  Always keep flood sources, syringes, waste, and other radioactive material in shielded 

22 containers. 

23  Secure all licensed material when not under the constant surveillance and immediate 

24 control of an individual authorized under the U.S. Nuclear Regulatory Commission 

25 license (or such individual’s designee). 
1 APPENDIX U 

2 MODEL PROCEDURES FOR RELEASE OF PATIENTS OR HUMAN 

3 RESEARCH SUBJECTS ADMINISTERED RADIOACTIVE MATERIALS 

U–1 

1 Model Procedures for Release of Patients or Human Research Subjects 

2 Administered Radioactive Materials 

3 In this Appendix, the individual or human research subject to whom the radioactive material has 

4 been administered is called the “patient.” This model provides acceptable procedures for the 

5 release of patients, under Title 10 of the Code of Federal Regulations (CFR) 10 CFR 35.75, who 

6 are administered radioactive materials. Regulations in 10 CFR Part 35.75 permit a licensee to 

7 “authorize the release from its control any individual who has been administered unsealed 

8 byproduct material or implants containing byproduct material if the total effective dose 

9 equivalent (TEDE) to any other individual from exposure to the released individual is not likely to 

10 exceed 5 millisieverts (mSv) (0.5 rem).” However, a patient who meets the release criteria in 

11 10 CFR 35.75 is not required to be released immediately following administration of radioactive 

12 materials. Inpatient treatment is always an option and may be the appropriate choice, given the 

13 patient’s specific situation. 

14 Licensees should review Information Notice (IN) 2003-22, “Heightened Awareness for Patients 

15 Containing Detectable Amounts of Radiation from Medical Administrations,” December 9, 2003, 

16 and Supplement 1, July 29, 2009, in developing instructions for patients that still contain 

17 detectable amounts of radiation and provide patients with an appropriate explanation about the 

18 potential of alarming radiation monitoring equipment. 

19 Special Considerations and Guidance for Release of Patients Following I-131 

20 Therapy 

21 Although the regulations are not explicit, licensees should consider implementing the 5 mSv 

22 [0.5 rem] as an annual limit for multiple administrations during a calendar year. For more 

23 information on this topic see Regulatory Issue Summary (RIS) 2008-07, “Dose Limits for Patient 

24 Release Under 10 CFR 35.75,” March 27, 2008. 

25 Although 10 CFR 35.75 does not expressly prohibit the release of a radioactive patient to a 

26 location other than a private residence, the U.S. Nuclear Regulatory Commission (NRC) 

27 strongly discourages this practice, because it can result in radiation exposures to members of 

28 the public for which the licensee may not be able to fully assess compliance with 10 CFR 

29 35.75(a) and may result in doses that are not as low as is reasonably achievable (ALARA). For 

30 more information on this topic, see RIS 2011-01, “NRC Policy on Release of Iodine-131 

31 Therapy Patients Under 10 CFR 35.75 to Locations Other Than Private Residences,” 

32 January 25, 2011. 

33 Licensees should take into account whether the released patient may come in contact with 

34 infants or young children. In such a situation, in order to protect infants and young children from 

35 possible iodine-131 (I-131) contamination, the licensee should provide the patient with 

36 additional instructions. These additional instructions are listed in Section U.2.3.1, “Instructions 

37 Regarding Radiopharmaceutical Administrations.” For more information on this topic see RIS 

38 2008-11, “Precautions to Protect Children Who May Come In Contact with Patients Released 

39 After Therapeutic Administrations of Iodine-131,” May 12, 2008. 

40 Release Equation 

41 The activity at which patients could be released was calculated by using, as a starting point, the 

42 method discussed in the National Council on Radiation Protection and Measurements (NCRP) 

43 Report No. 37, “Precautions in the Management of Patients Who Have Received Therapeutic 
U–2 

1 Amounts of Radionuclides.” This report uses the following equation to calculate the exposure 

2 until time t at a distance r from the patient: 

3 Equation U–1: 

4 where: D(t) = Accumulated exposure at time t, in roentgens (R) 

5 34.6 = Conversion factor of 24 hours/day times the total integration of 

6 decay (1.44) 

7 Γ = Specific gamma ray constant for a point source, R/millicuries (mCi)-h at 

8 1 centimeter (cm) 

9 Q0 = Initial activity of the point source in mCi, at the time of the release 

10 Tp = Physical half-life in days 

11 r = Distance from the point source to the point of interest, in cm 

12 t = Exposure time in days. 

13 This Appendix uses the NCRP equation (Equation U–1) in the following manner to calculate the 

14 activities at which patients may be released. 

15  The dose to an individual likely to receive the highest dose from exposure to the patient 

is taken to be the dose to total decay. Therefore, (1-e -0.693t/Tp 16 ) is set equal to 1. 

17  It is assumed that 1 roentgen is equal to 10 mSv [1 rem]. 

18  The exposure-rate constants and physical half-lives for radionuclides typically used in 

19 nuclear medicine and brachytherapy procedures are given in Table U–5. 

20  Default activities at which patients may be released are calculated using the physical 

21 half-lives of the radionuclides and do not account for the biological half-lives of the 

22 radionuclides. 

23  When release is based on biological elimination (i.e., the effective half-life) rather than 

24 just the physical half-life of the radionuclide, Equation U–1 is modified to account for the 

25 uptake and retention of the radionuclide by the patient, as discussed in Supplement B.2. 

26  For radionuclides with a physical half-life greater than 1 day and no consideration of 

27 biological elimination, it is assumed that the individual likely to receive the highest dose 

28 from exposure to the patient would receive a dose of 25% of the dose to total decay 

29 (0.25 in Equation U–2), at a distance of 1 meter. Selection of 25% of the dose to total 

30 decay at 1 meter for estimating the dose is based on measurements discussed in the 

31 supporting regulatory analysis that indicate the dose calculated using an occupancy 

32 factor, E, of 25% at 1 meter is conservative in most normal situations. 

33  For radionuclides with a physical half-life less than or equal to 1 day, it is difficult to 

34 justify an occupancy factor of 0.25, because relatively long-term averaging of behavior 

35 cannot be assumed. Under this situation, occupancy factors from 0.75 to 1.0 may be 

36 more appropriate. 

r

34.6 Q T (1- e ) D(t)= 2

-0.693t/T

0 P  P
U–3 

1 Thus, for radionuclides with a physical half-life greater than 1 day: 

2 Equation U–2: 

ܦሺ∞ሻ ൌ 34.6	Γ	Q଴T୮ሺ0.25ሻ

ሺ100	cmሻଶ

3 For radionuclides with a physical half-life less than or equal to 1 day, and if an occupancy factor 

4 of 1.0 is used: 

5 Equation U–3: 

ܦሺ∞ሻ ൌ 34.6	Γ	Q଴T୮ሺ1ሻ

ሺ100	cmሻଶ

6 Equations U–2 and U–3 calculate the dose from external exposure to gamma radiation. These 

7 equations do not include the dose from internal intake by household members and members of 

8 the public because the dose from intake by other individuals is expected to be small for most 

9 radiopharmaceuticals (i.e., less than a few percent), relative to the external gamma dose. For 

10 some radionuclides, such as sodium iodide I-131, it may be necessary to also consider the 

11 internal dose from exposure to a released patient. The internal and external doses must be 

12 summed to determine the total dose. See Supplement B.3, “Internal Dose” for equations. 

13 Further, the equations above do not apply to the dose to breastfeeding infants or children who 

14 continue to breastfeed. Patients who are breastfeeding an infant or child must be considered 

15 separately, as discussed in Section U.1.1, “Release of Patients Based on Administered Activity.” 

16 U.1 Release Criteria 

17 Licensees should use one of the following options (U.1.1, U.1.2. or U.1.3.) to release a patient 

18 to whom unsealed byproduct material or implants containing byproduct material have been 

19 administered in accordance with regulatory requirements. 

20 Licensees should perform an assessment in advance of the treatment to validate the factors 

21 used in release equations, including confirmation that default values used are appropriate for 

22 the patient’s situation. Licensees should have a program that includes a structured series of 

23 questions and maintain documentation of responses. Examples of items to consider in the 

24 assessment can be found in “Radiation Safety in the Treatment of Patients with Thyroid 

Diseases by Radioiodine 131 25 I: Practice Recommendations of the American Thyroid 

26 Association.”

27 U.1.1 Release of Patients Based on Administered Activity 

28 In compliance with the dose limit in 10 CFR 35.75(a), licensees may release patients from 

29 licensee control if the activity administered is no greater than the activity in Column 1 of 

30 Table U–1. The activities in Table U–1 are based on a TEDE of 5 mSv [0.5 rem] to an individual 

31 using the following conservative assumptions: 

32  administered activity 

33  physical half-life 
U–4 

1  occupancy factor of 0.25 at 1 meter for physical half-lives greater than 1 day and, to be 

2 conservative, an occupancy factor of 1 at 1 meter for physical half-lives less than or 

3 equal to 1 day 

4  no shielding by tissue 

5 Because the values in Table U–1 are based on Equations U–2 and U–3, licensees should 

6 perform patient-specific dose calculations, if it is determined that a different occupancy factor is 

7 appropriate for the patient’s situation. See Section U.1.3 and Supplement B for details on 

8 patient-specific dose calculations. 

9 The TEDE is approximately equal to the external dose because the internal dose is a small 

10 fraction of the external dose. See Section B.3, “Internal Dose,” of Supplement B. In this case, 

11 no record of the release of the patient is required unless the patient is breastfeeding an infant or 

12 child, as discussed in Section U.3.2, “Records of Instructions for Breastfeeding Patients.” The 

13 licensee may demonstrate compliance by using the records of activity that are already required 

14 by 10 CFR 35.40 and 35.63. 

15 If the activity administered exceeds the activity in Column 1 of Table U–1, the licensee may 

16 release the patient when the activity has decayed to the activity in Column 1 of Table U–1. In 

17 this case, 10 CFR 35.75(c) requires a record because the patient’s release is based on the 

18 retained activity rather than the administered activity. The activities in Column 1 of Table U–1

19 were calculated using either Equation U–2 or U–3, depending on the physical half-life of 

20 the radionuclide. 

21 If a radionuclide that is not listed in Table U–1 is administered, the licensee can demonstrate 

22 compliance with the regulation by maintaining, for NRC inspection, a calculation of the release 

23 activity that corresponds to the dose limit of 5 mSv [0.5 rem]. Equation U–2 or U–3 may be 

24 used, as appropriate, to calculate the activity Q corresponding to 5 mSv [0.5 rem]. 

25 The release activities in Column 1 of Table U–1 do not include consideration of the dose to a 

26 breastfeeding infant or child from ingestion of radiopharmaceuticals contained in the patient’s 

27 breast milk. When the patient is breastfeeding an infant or child, the activities in Column 1 of 

28 Table U–1 are not applicable to the infant or child. In this case, it may be necessary to give 

29 instructions as described in Sections U.2.2 and U.2.3 as a condition for release. If failure to 

30 interrupt or discontinue could result in a dose to the breastfeeding infant or child in excess of 

31 5 mSv [0.5 rem], a record that instructions were provided is required by 10 CFR 35.75(d). 

32 U.1.2 Release of Patients Based on Measured Dose Rate 

33 Licensees may release patients to whom radionuclides have been administered in amounts 

34 greater than the activities listed in Column 1 of Table U–1, provided the measured dose rate at 

35 1 meter (from the surface of the patient) is no greater than the value in Column 2 of Table U–1

36 for that radionuclide. In this case, however, 10 CFR 35.75(c) requires a record because the 

37 release is based on considering shielding by tissue. 

38 If a radionuclide not listed in Table U–1 is administered and the licensee chooses to release a 

39 patient based on the measured dose rate, the licensee should first calculate a dose rate that 

40 corresponds to the 5 mSv [0.5 rem] dose limit. If the measured dose rate at 1 meter is no 

41 greater than the calculated dose rate, the patient may be released. A record of the release is 

42 required by 10 CFR 35.75(c). The dose rate at 1 meter may be calculated from Equation U–2
U–5 

1 or U–3, as appropriate, because the dose rate at 1 meter is equal to Γ Q / 10,000 square 

2 centimeters. 

3 Because the values in Table U–1 are based on Equations U–2 and U–3, patient-specific dose 

4 calculations should be performed, if it is determined that a different occupancy factor is 

5 appropriate for the patient’s situation. See Section U.1.3 and Supplement B for details on 

6 patient-specific dose calculations. 

7 U.1.3 Release of Patients Based on Patient-Specific Dose Calculations 

8 Licensees may release patients based on dose calculations using patient-specific parameters. 

9 With this method, based on 10 CFR 35.75(a), the licensee must calculate the maximum likely 

10 dose to an individual exposed to the patient on a case-by-case basis. If the calculated 

11 maximum likely dose to an individual is no greater than 5 mSv [0.5 rem], the patient may be 

12 released. Using this method, licensees may be able to release patients with activities greater 

13 than those listed in Column 1 of Table U–1 by taking into account the effective half-life of the 

14 radioactive material and other factors that may be relevant to the particular case. In this case, a 

15 record of the release is required by 10 CFR 35.75(c). If the dose calculation considered 

16 retained activity, an occupancy factor less than 0.25 at 1 meter, effective half-life, or shielding by 

17 tissue, a record of the basis for the release is required by 10 CFR 35.75(c). 

18 Supplement B contains procedures for performing patient-specific dose calculations, and it 

19 describes how various factors may be considered in the calculations. 

Table U–1. Activities and Dose Rates for Authorizing Patient Release* 

Radionuclide Column 1 Column 2 

GBq mCi mSv/h mrem/h

silver-111 19 520 0.08 8 

gold-198 3.5 93 0.21 21 

chromium-51 4.8 130 0.02 2 

copper-64 8.4 230 0.27 27 

copper-67 14 390 0.22 22 

gallium-67 8.7 240 0.18 18 

iodine-123 6 160 0.26 26 

iodine-125 0.25 7 0.01 1 

iodine-125 implant 0.33 9 0.01 1 

iodine-131 1.2 33 0.07 7 

indium-111 2.4 64 0.2 20 

iridium-192 implant 0.074 2 0.008 0.8 

phosphorus-32 † † † †

Pd-103 implant 1.5 40 0.03 3 

rhenium-186 28 770 0.15 15 

rhenium-188 29 790 0.2 20 

scandium-47 11 310 0.17 17 

selenium-75 0.089 2 0.005 0.5 

samarium-153 26 700 0.3 30 

tin-117m 1.1 29 0.04 4 
U–6 

Table U–1. Activities and Dose Rates for Authorizing Patient Release* (Continued)

Radionuclide

Column 1 Column 2 

GBq mCi mSv/h mrem/h

stontium-89 † † † †

technetium-99m 28 760 0.58 58 

thallium-201 16 430 0.19 19 

yttrium-90 † † † †

ytterbium-169 0.37 10 0.02 2 

*The activity values were computed based on 5 mSv [0.5 rem] TEDE. 

†

Activity and dose rate limits are not applicable in this case because of the minimal exposures to members of the 

public resulting from activities normally administered for diagnostic or therapeutic purposes. 

Note: If the release is based on the dose rate at 1 meter in Column 2, the licensee must maintain a record as 

required by 10 CFR 35.75(c), because the measurement includes shielding by tissue. See Section U.3.1, “Records 

of Release,” for information on records.

1 Notes: 

2  The mCi values were calculated using Equations U–2 and U–3 and the physical half-life. 

3 The gigabecquerel (GBq) values were calculated using the mCi values and the 

4 conversion factor from mCi to GBq. The dose rate values are calculated using the mCi 

5 values and the exposure rate constants.

6  In general, the values are rounded to two significant figures; however, values less than 

7 0.37 GBq [10 mCi] or 0.1 mSv [10 millirem (mrem)] per hour are rounded to one 

8 significant figure. Details of the calculations are provided in NUREG–1492, “Regulatory 

9 Analysis on Criteria for the Release of Patients Administered Radioactive Material,” 

10 February 1997.

11  Agreement State regulations may vary. Agreement State licensees should check with 

12 their State regulations before using these values.

13 U.2 Instructions 

14 This Section provides acceptable instructions for release of patients administered radioactive 

15 materials. Licensees may either adopt these model instructions or develop their own 

16 instructions to meet the requirements of 10 CFR 35.75. 

17 U.2.1 Activities and Dose Rates Requiring Instructions 

18 Based on 10 CFR 35.75(b), for some administrations the released patients must be given 

19 instructions, including written instructions, on how to maintain doses to other individuals ALARA 

20 after the patients are released. NRC cannot enforce patient compliance with the instructions, 

21 nor is it the licensee’s responsibility to do so. Column 1 of Table U–2 provides the activity 

22 above which instructions must be given to patients. Column 2 provides corresponding dose 

23 rates at 1 meter, based on the activities in Column 1. The activities or dose rates in Table U–2

24 may be used for determining when instructions must be given. If the patient is breastfeeding an 

25 infant or child, additional instructions may be necessary. (See Section U.2.2, “Additional 

26 Instructions for Release of Patients Who Could Be Breastfeeding after Release.”) 
U–7 

1 When patient-specific calculations (as described in Supplement B) are used, instructions must 

2 be provided if the calculation indicates a dose greater than 1 mSv [0.1 rem]. 

3 If a radionuclide not listed in Table U–2 is administered, the licensee may calculate the activity 

4 or dose rate that corresponds to 1 mSv [0.1 rem]. Equation U–2 or U–3, as appropriate, may 

5 be used. 

6 U.2.2 Additional Instructions for Release of Patients Who Could Be 

7 Breastfeeding After Release 

8 The requirement in 10 CFR 35.75(b) that a licensee provide instructions on the discontinuation 

9 or the interruption period of breastfeeding, and the consequences of failing to follow the 

10 recommendation, presumes the licensee will inquire, as appropriate, regarding the 

11 breastfeeding status of the patient. 

12 Note: The NRC does not intend to enforce patient compliance with the instructions, nor is it the 

13 licensee’s responsibility to do so. The purpose of the instructions (e.g., on interruption or 

14 discontinuation) is to permit licensees to release a patient who could be breastfeeding an infant 

15 or child when the dose to the infant or child could exceed 5 mSv [0.5 rem], if there is no 

16 interruption of breastfeeding. 

17 If the patient could be breastfeeding an infant or child after release, and if a radiopharmaceutical 

18 with an activity above the value stated in Column 1 of Table U–3 was administered to the 

19 patient, the licensee must give the patient instructions on the discontinuation or interruption 

20 period for breastfeeding and the consequences of failing to follow the recommendation. The 

21 patient should also be informed if there would be no consequences to the breastfeeding infant 

22 or child. Table U–3 also provides recommendations for interrupting or discontinuing 

23 breastfeeding to minimize the dose to below 1 mSv [0.1 rem] if the patient has received certain 

24 radiopharmaceutical doses. The radiopharmaceuticals listed in Table U–3 are commonly used 

25 in medical diagnosis and treatment. 

26 If a radiopharmaceutical not listed in Table U–3 is administered to a patient who could be 

27 breastfeeding, the licensee should evaluate whether instructions or records (or both) are 

28 required. If information on the excretion of the radiopharmaceutical is not available, an 

29 acceptable method is to assume that 50% of the administered activity is excreted in the breast 

30 milk. The dose to the infant or child can be calculated by using the dose conversion factors 

31 given for a newborn infant in an article by Michael Stabin entitled “Internal Dosimetry in Pediatric 

32 Nuclear Medicine,” published in Pediatric Nuclear Medicine (edited by S. Treves, Springer 

33 Verlag, New York, 1995). 

34 U.2.3 Content of Instructions 

35 The instructions should be specific to the type of treatment given, such as permanent implants 

36 or radioiodine therapy, and they may include additional information for individual situations; 

37 however, the instructions should not interfere with or contradict the best medical judgment of 

38 physicians. The instructions may include the name of a knowledgeable contact person and that 

39 person’s telephone number, in case the patient has any questions. Additional instructions 

40 appropriate for each modality, as shown in examples below, may be provided (refer to 

41 Sections U.2.3.1 and U.2.3.2). 
U–8 

Table U–2. Activities and Dose Rates Above Which Instructions Should Be Given 

When Authorizing Patient Release* 

Radionuclide

Column 1 

Activity Above Which Instructions 

Are Required

Column 2 

Dose Rate at 1 Meter Above Which 

Instructions Are Required

(GBq) (mCi) (mSv/h) (mrem/h)

silver-111 3.8 100 0.02 2 

gold-198 0.69 19 0.04 4 

chromium-51 0.96 26 0.004 0.4 

copper-64 1.7 45 0.05 5 

copper-67 2.9 77 0.04 4 

gallium-67 1.7 47 0.04 4 

iodine-123 1.2 33 0.05 5 

iodine-125 0.05 1 0.002 0.2 

iodine-125 

implant 

0.074 2 0.002 0.2 

iodine-131 0.24 7 0.02 2 

indium-111 0.47 13 0.04 4 

iridium-192 

implant 

0.011 0.3 0.002 0.2 

phosphorus-32 † † † †

Pd-103 implant 0.3 8 0.007 0.7 

rhenium-186 5.7 150 0.03 3 

rhenium-188 5.8 160 0.04 4 

scandium-47 2.3 62 0.03 3 

selenium-75 0.018 0.5 0.001 0.1 

samarium-153 5.2 140 0.06 6 

tin-117m 0.21 6 0.009 0.9 

stontium-89 † † † †

technetium-99m 5.6 150 0.12 12 

thallium-201 3.1 85 0.04 4 

yttrium-90 † † † †

ytterbium-169 0.073 2 0.004 0.4 

*The activity values were computed based on 1 mSv [0.1 rem] TEDE. 

†

Activity and dose rate limits are not applicable in this case, because of the minimal exposures to members of the 

public resulting from activities normally administered for diagnostic or therapeutic purposes.

1 Notes: 

2  The values for activity were calculated using Equations U–2 and U–3 and the physical 

3 half-life. The values given in International System of Units (GBq values) were using 

4 conversion factors.

5  In general, values are rounded to two significant figures; however, values less than 

6 0.37 GBq [10 mCi] or 0.1 mSv [10 mrem] per hour are rounded to one significant figure. 

7 Details of the calculations are provided in NUREG–1492, “Regulatory Analysis on 

8 Criteria for the Release of Patients Administered Radioactive Material,” February 1997.
U–9 

1  Agreement State regulations may vary. Agreement State licensees should check their 

2 State regulations before using these values.

Table U–3. Activities of Radiopharmaceuticals That Require Instructions and Records 

When Administered to Patients Who Are Breastfeeding an Infant or Child 

Radiopharmaceutical

Column 1 

Activity Above Which

Instructions Are 

Required

Column 2 

Activity Above 

Which 

a Record is 

Required

Column 3* 

Examples of Recommended 

Duration of Interruption of 

(MBq) (mCi) (MBq) (mCi) Breastfeeding

I-131 NaI 0.01 0.0004 0.07 0.002 Complete cessation for this 

infant or child 

I-123 NaI 20 0.5 100 3 

I-123 OIH 100 4 700 20 

I-123 MIBG 70 2 400 10 24 hours for 370 MBq 

[10 mCi] 

12 hours for 150 MBq [4 mCi]

I-125 OIH 3 0.08 10 0.4 

I-131 OIH 10 0.3 60 1.5 

Tc-99m DTPA 1000 30 6000 150 

Tc-99m MAA 50 1.3 200 6.5 12.6 hours for 150 MBq 

[4 mCi] 

Tc-99m 

Pertechnetate 

100 3 600 15 24 hours for 1,100 MBq 

[30 mCi] 

12 hours for 440 MBq 

[12 mCi] 

Tc-99m DISIDA 1000 30 6000 150 

Tc-99m 

Glucoheptonate 

1000 30 6000 170 

Tc-99m MIBI 1000 30 6000 150 

Tc-99m MDP 1000 30 6000 150 

Tc-99m PYP 900 25 4000 120 

Tc-99m Red 

Blood Cell In Vivo

Labeling 

400 10 2000 50 6 hours for 740 MBq 

[20 mCi] 

Tc-99m Red 

Blood Cell In Vitro

Labeling 

1000 30 6000 150 

Tc-99m Sulfer 

Colloid 

300 7 1000 35 6 hours for 440 MBq [12 mCi]

Tc-99m DTPA 

Aerosol 

1000 30 6000 150 

Tc-99m MAG3 1000 30 6000 150 

Tc-99m White 

Blood Cells 

100 4 600 15 24 hours for 1,100 MBq 

[30 mCi] 

12 hours for 440 MBq 

[12 mCi] 

 
U–10 

Table U–3. Activities of Radiopharmaceuticals That Require Instructions and Records 

When Administered to Patients Who Are Breastfeeding an Infant or Child 

(Continued)

Radiopharmaceutical

Column 1 

Activity Above Which

Instructions Are 

Required

Column 2 

Activity Above 

Which 

a Record is 

Required

Column 3* 

Examples of Recommended 

Duration of Interruption of 

(MBq) (mCi) (MBq) (mCi) Breastfeeding

Ga-67 Citrate 1 0.04 7 0.2 1 month for 150 MBq 

[4 mCi] 

2 weeks for 50 MBq 

[1.3 mCi] 

1 week for 7 MBq 

[0.2 mCi] 

Cr-51 EDTA 60 1.6 300 8 

In-111 White 

Blood Cells 

10 0.2 40 1 1 week for 20 MBq 

[0.5 mCi] 

Tl-201 Chloride 40 1 200 5 2 weeks for 110 MBq 

[3 mCi] 

*The duration of interruption of breastfeeding is selected to reduce the maximum dose to a newborn infant to less 

than 1 mSv [0.1 rem], although the regulatory limit is 5 mSv [0.5 rem]. The actual doses that would be received by 

most infants would be far below 1 mSv [0.1 rem]. Of course, the physician may use discretion in the 

recommendation, increasing or decreasing the duration of interruption. 

Notes:

1  Activities are rounded to one significant figure, except when it was considered 

2 appropriate to use two significant figures. Details of the calculations are shown in 

3 NUREG–1492, “Regulatory Analysis on Criteria for the Release of Patients Administered 

4 Radioactive Material,” February 1997.

5  If there is no recommendation in Column 3 of this table, the maximum activity normally 

6 administered is below the activities that require instructions on interruption or 

7 discontinuation of breastfeeding.

8  Agreement State regulations may vary. Agreement State licensees should check their 

9 State regulations before using these values.

10 U.2.3.1 Instructions Regarding Radiopharmaceutical Administrations 

11 For procedures involving radiopharmaceuticals, additional instructions may include the 

12 following: 
U–11 

You have been administered radioactive material for therapeutic medical purposes. To 

minimize exposure to radiation to others from the radioactive material inside your body, you 

should do the following for days: 

 Maintain distance from other persons (e.g., use separate sleeping arrangements, no 

cuddling or holding children). 

 Minimize time in public places (e.g., public transportation, grocery stores, shopping 

centers, theaters, restaurants, sporting events). 

 Reduce the spread of radioactive contamination (e.g., do not share towels or 

washcloths; wash linens separately; and do not share cups, glasses, plates, or eating 

utensils). 

Refrain from returning to work for _____ days. 

Additionally for some types of therapy: 

 Drink one glass of water each hour and use the bathroom as soon as possible to empty 

bladder. 

 Men should sit on the toilet while urinating to decrease splashing. 

 Use a tissue to wipe up any urine on the toilet bowl and flush twice. 

 Wash hands after urinating. 

 Rinse the sink and tub after each use. 

 Minimize time with children and pregnant women. 

 Avoid direct or indirect contact (e.g., indirect contact includes contamination from shared 

living space) with infants and young children for a specific period of time (e.g., consider 

having children stay outside the home with other family members). 

 Establish adequate living space at home (e.g., bedroom, bathroom) that can be used 

exclusively by the patient for a specific period of time. 

 For women who are breastfeeding, consult physician before resuming breastfeeding. 

1 Licensees should consider not releasing patients administered I-131, whose living conditions 

2 may result in the contamination of infants and young children. The licensee should provide 

3 information on the potential consequences, if any, from failure to follow these instructions 

4 (e.g., could result in significant doses to the child’s thyroid and potentially raise the risk of 

5 subsequent radiation-induced thyroid cancer). 

6 If additional instructions are required because the patient is breastfeeding, the instructions 

7 should include appropriate recommendations on whether to interrupt breastfeeding, the length 

8 of time to interrupt breastfeeding, or, if necessary, the discontinuation of breastfeeding. The 

9 instructions should include information on the consequences of failure to follow the 

10 recommendation to interrupt or discontinue breastfeeding. The consequences should be 
U–12 

1 explained so that the patient will understand that, in some cases, breastfeeding after an 

2 administration of certain radionuclides should be avoided. For example, a consequence of 

3 procedures involving sodium iodide I-131 is that continued breastfeeding could harm the infant’s 

4 or child’s thyroid. Most diagnostic procedures involve radionuclides other than radioiodine and 

5 there would be no consequences; guidance should simply address avoiding any unnecessary 

6 radiation exposure to the infant or child from breastfeeding. The requirement of 

7 10 CFR 35.75(b) regarding written instructions to patients who could be breastfeeding an infant 

8 or child is not in any way intended to interfere with the discretion and judgment of the physician 

9 in providing detailed instructions and recommendations. 

10 U.2.3.2 Instructions Regarding Implants 

11 For patients who have received implants, additional instructions may include the following: 

A small radioactive source has been placed (implanted) inside your body. The source is 

actually many small metallic pellets or seeds, which are each about 1/3 to 1/4 of an inch long, 

similar in size and shape to a grain of rice. To minimize exposure to radiation to others from 

the source inside your body, you should do the following for days: 

 Stay at a distance of feet from other individuals. 

 Maintain separate sleeping arrangements. 

 Minimize time with children and pregnant women. 

 Do not hold or cuddle children. 

 Avoid public transportation. 

 Examine any bandages or linens that come into contact with the implant site for any 

pellets or seeds that may have come out of the implant site. 

 If you find a seed or pellet that falls out 

— Do not handle it with your fingers. Use something like a spoon or tweezers to 

place it in a jar or other container that you can close with a lid. 

— Place the container with the seed or pellet in a location away from people. 

— Notify _________________________ at telephone number _______________. 

12 U.3 Records 

13 U.3.1 Records of Release 

14  There is no requirement for recordkeeping on the release of patients who were released 

15 in accordance with Column 1 of Table U–1; however, if the release of the patient is 

16 based on a dose calculation that considered retained activity, an occupancy factor less 

17 than 0.25 at 1 meter, effective half-life, or shielding by tissue, a record of the basis for 

18 the release is required by 10 CFR 35.75(c). This record should include the patient 

19 identifier (in a way that ensures that confidential patient information is not traceable or 
U–13 

1 attributable to a specific patient), the radioactive material administered, the administered 

2 activity, and the date of the administration. In addition, depending on the basis for 

3 release, records should include the following information: For Immediate Release of a 

4 Patient Based on a Patient-Specific Calculation: The equation used, including the 

5 patient-specific factors and their bases that were used in calculating the dose to the 

6 person exposed to the patient, and the calculated dose. The patient-specific factors 

7 (see Supplement B of this Appendix) include the effective half-life and uptake fraction for 

8 each component of the biokinetic model, the time that the physical half-life was assumed 

9 to apply to retention, and the occupancy factor. The basis for selecting each of these 

10 values should be included in the record. 

11  For Immediate Release of a Patient Based on Measured Dose Rate: The results of 

12 the measurement, the specific survey instrument used, and the name of the individual 

13 performing the survey. 

14  For Delayed Release of a Patient Based on Radioactive Decay Calculation: The 

15 time of the administration, the date and time of release, and the results of the decay 

16 calculations.

17  For Delayed Release of a Patient Based on Measured Dose Rate: The results of the 

18 radiation survey meter measurement, the specific survey instrument used, and the name 

19 of the individual performing the survey. 

20 In some situations, a calculation may be case-specific for a class of patients who all have the 

21 same patient-specific factors. In this case, the record for a particular patient’s release may 

22 reference the calculation for the class of patients. 

23 Records, as required by 10 CFR 35.75(c), should be kept in a manner that ensures the patient’s 

24 confidentiality; that is, the records should not contain the patient’s name or any other information 

25 that could lead to identification of the patient. These recordkeeping requirements may also be 

26 used to verify that licensees have proper procedures in place for assessing potential third-party 

27 exposure associated with and arising from exposure to patients who were administered 

28 radioactive material. 

29 U.3.2 Records of Instructions for Breastfeeding Patients 

30 If failure to interrupt or discontinue breastfeeding could result in a dose to the infant or child in 

31 excess of 5 mSv [0.5 rem], a record that instructions were provided is required by 

32 10 CFR 35.75(d). Column 2 of Table U–3 states, for the radiopharmaceuticals commonly used 

33 in medical diagnosis and treatment, the activities that would require such records when 

34 administered to patients who are breastfeeding. 

35 The record should include the patient’s identifier (in a way that ensures that confidential patient 

36 information is not traceable or attributable to a specific patient), the radiopharmaceutical 

37 administered, the administered activity, the date of the administration, and whether instructions 

38 were provided to the patient who could be breastfeeding an infant or child. 

39 U.4 Summary Table 

40 Table U–4 summarizes the criteria for releasing patients and the requirements for providing 

41 instructions and maintaining records. 
U–14 

Table U–4. Summary of Release Criteria, Required Instructions to Patients, and 

Records To Be Maintained 

Patient Group Basis for 

Release 

Criteria for 

Release

Instructions 

Needed? 

Release 

Records 

Required? 

All patients, 

including patients 

who are 

breastfeeding an 

infant or child 

Administered 

activity 

Administered 

activity ≤Column 1 

of Table U–1 

Yes – if administered 

activity > Column 1 

of Table U–2 

No 

Retained activity Retained activity ≤

Column 1 of 

Table U–1 

Yes – if retained 

activity > Column 1 

of Table U–2 

Yes 

Measured dose 

rate 

Measured dose 

rate ≤ Column 2 of 

Table U–1 

Yes – if dose rate > 

Column 2 of 

Table U–2 

Yes 

Patient-specific 

calculations 

Calculated dose ≤

5 mSv [0.5 rem] 

Yes – if calculated 

dose > 1 mSv 

[0.1 rem] 

Yes 

Patients who are 

breastfeeding an 

infant or child 

All the above 

bases for release

 Additional 

instructions required 

if: 

Administered activity 

> Column 1 of 

Table U–3 

or 

Licensee calculated 

dose from 

breastfeeding > 1 

mSv [0.1 rem] to the 

infant or child 

Records that 

instructions 

were provided 

are required if:

Administered 

activity > 

Column 2 of 

Table U–3 

or 

Licensee 

calculated dose 

from continued 

breastfeeding > 

5 mSv [0.5 rem]

to the infant or 

child 

1 Implementation 

2 The purpose of this section is to provide information to licensees and applicants regarding the 

3 NRC staff’s plans for using this Appendix. Except in those cases in which a licensee proposes 

4 an acceptable alternative method for complying with 10 CFR 35.75, the methods described in 

5 this Appendix will be used in the evaluation of a licensee’s compliance with 10 CFR 35.75. 
U–15 

1 Supplement A 

Table U–5. Half-Lives and Exposure Rate Constants of Radionuclides Used 

in Medicine 

Radionuclide Physical Half-Life (days)* Exposure Rate Constant† (R/mCi-h at 1 cm)

silver-111 7.45 0.15 

gold-198 2.696 2.3 

chromium-51 27.704 0.16 

copper-64 0.529 1.2 

copper-67 2.578 0.58 

gallium-67 3.261 0.753 

iodine-123 0.55 1.61 

iodine-125 60.14 1.42 

iodine-125 implant‡ 60.14 1.114 

iodine-131 8.04 2.2 

indium-111 2.83 3.21 

iridium-192 implant‡ 74.02 4.594 

phosphorus-32 14.29 N/A§

Pd-103 implant║ 16.96 0.865 

rhenium-186 3.777 0.2 

rhenium-188 0.708 0.26 

scandium-47 3.351 0.56 

selenium-75 119.8 2 

samarium-153 13.61 1.48 

tin-117m 50.5 N/A§

stontium-89 0.251 0.756 

technetium-99m 3.044 0.447 

thallium-201 32.01 1.83 

 
U–16 

Table U–5. Half-Lives and Exposure Rate Constants of Radionuclides Used 

in Medicine (Continued)

Radionuclide Physical Half-Life (days)* Exposure Rate Constant† (R/mCi-h at 1 cm)

yttrium-90 2.67 N/A§

ytterbium-169 32.01 1.83 

*K. F. Eckerman, A. B. Wolbarst, and A. C. B. Richardson, “Federal Guidance Report No. 11, Limiting Values of 

Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion,” 

Report No. EPA-520/1-88-020, Office of Radiation Programs, U.S. Environmental Protection Agency, Washington, 

DC, 1988. 

†

Values for the exposure rate constant for Au-198, Cr-51, Cu-64, I-131, Sc-47, and Se-75 were taken from the 

Radiological Health Handbook, U.S. Department of Health, Education, and Welfare, p. 135, 1970. For Cu-67, I-123, 

In-111, Re-186, and Re-188, the values for the exposure rate constant were taken from D. E. Barber, J. W. Baum, 

and C. B. Meinhold, “Radiation Safety Issues Related to Radiolabeled Antibodies,” NUREG/CR-4444, U.S. NRC, 

Washington, DC, 1991. For Ag-111, Ga-67, I-125, Sm-153, Sn-117m, Tc-99m, Tl-201, and Yb-169, the exposure 

rate constants were calculated because the published values for these radionuclides were an approximation, 

presented as a range, or varied from one reference to another. Details of the calculation of the exposure rate 

constants are shown in Table A.2 of Appendix A to NUREG–1492, “Regulatory Analysis on Criteria for the Release 

of Patients Administered Radioactive Material,” February 1997. 

‡

R. Nath, A. S. Meigooni, and J. A. Meli, “Dosimetry on Transverse Axes of 125I and 192Ir Interstitial Brachytherapy 

Sources,” Medical Physics, Volume 17, Number 6, November/December 1990. The exposure rate constant given is 

a measured value averaged for several source models and takes into account the attenuation of gamma rays within 

the implant capsule itself. 

§

S. Meigooni, S. Sabnis, R. Nath, “Dosimetry of Palladium-103 Brachytherapy Sources for Permanent Implants,” 

Endocurietherapy Hyperthermia Oncology, Volume 6, April 1990. The exposure rate constant given is an “apparent” 

value (i.e., with respect to an apparent source activity) and takes into account the attenuation of gamma rays within 

the implant capsule itself. 

║

Not applicable (N/A) because the release activity is not based on beta emissions.

1 Supplement B

2 Procedures for Calculating Doses Based on Patient-Specific Factors 

3 A licensee may release a patient to whom an activity with a value higher than the values listed 

4 in Column 1 of Table U–1 of this supplement has been administered if dose calculations using 

5 patient-specific parameters, which are less conservative than the conservative assumptions, 

6 show that the potential TEDE to any individual would be no greater than 5 mSv [0.5 rem]. 

7 If the release of a patient is based on a patient-specific calculation that considered retained 

8 activity, an occupancy factor less than 0.25 at 1 meter, biological or effective half-life, or 

9 shielding by tissue, a record of the basis of the release is required by 10 CFR 35.75(c). The 

10 following equation can be used to calculate doses: 

11 Equation B–1: 

ܦሺݐሻ ൌ 34.6	Γ	Q଴TE൫1 െ eି଴.଺ଽଷ୲/୘౦൯

ሺrሻଶ

12 where: D(t) = Accumulated dose to time t, in rem; 
U–17 

1 34.6 = Conversion factor of 24 hours/day times the total integration of 

2 decay (1.44); 

3 Γ = Exposure rate constant for a point source, R/mCi x h at 1 cm; 

4 Q0 = Initial activity at the start of the time interval; 

5 Tp = Physical half-life, in days; 

6 E = Occupancy factor that accounts for different 

7 occupancy times and distances when an individual is 

8 around a patient; 

9 r = Distance in cm. This value is typically 100 cm; and 

10 t = Exposure time in days. 

11 This calculation considers only the external dose to an individual from exposure to a released 

12 patient. For some radionuclides, such as sodium iodide I-131, it may be necessary to also 

13 consider the internal dose from exposure to a released patient. The internal and external doses 

14 must be summed to determine the total dose. See Section B.3, “Internal Dose,” for a discussion 

15 of internal dose. 

16 B.1 Occupancy Factor 

17 B.1.1 Rationale for Occupancy Factors Used to Derive Table U–1 

18 In Table U–1 in this Appendix, the activities at which patients could be released were calculated 

19 using the physical half-life of the radionuclide and an occupancy factor at 1 meter of either 0.25 

20 (if the radionuclide has a half-life longer than 1 day) or 1.0 (if the radionuclide has a half-life less 

21 than or equal to 1 day). The basis for the occupancy factor of 0.25 at 1 meter is that 

22 measurements of doses to family members, as well as considerations of normal human 

23 behavior [as discussed in the supporting regulatory analysis (Ref. B-11)], suggest that an 

24 occupancy factor of 0.25 at 1 meter, when used in combination with the physical half-life, will 

25 produce a generally conservative estimate of the dose to family members when instructions on 

26 minimizing doses to others are given. 

27 An occupancy factor of 0.25 at 1 meter may not be appropriate when the physical half-life is less 

28 than or equal to 1 day, and hence, the dose is delivered over a short time. Specifically, the 

29 assumptions regarding patient behavior that led to an occupancy factor of 0.25 at 1 meter 

30 include the assumption that the patient will not be in close proximity to other individuals for 

31 several days; however, when the dose is from a short-lived radionuclide, the time that 

32 individuals spend in close proximity to the patient immediately following release will be most 

33 significant because the dose to other individuals could be a large fraction of the total dose from 

34 the short-lived radionuclide. Thus, to be conservative when providing generally applicable 

35 release quantities that may be used with little consideration of the specific details of a particular 

36 patient’s release, the values calculated in Table U–1 were based on an occupancy factor of 1 at 

37 1 meter when the half-life is less than or equal to 1 day. If information about a particular patient 

38 implies the assumptions were too conservative, licensees may consider case-specific 

39 conditions. Conversely, if young children are present in the household of the patient who is to 

40 be discharged, conservative assumptions about occupancy may be appropriate. 
U–18 

1 B.1.2 Occupancy Factors to Consider for Patient-Specific Calculations 

2 The selection of an occupancy factor for patient-specific calculations will depend on whether the 

3 physical or effective half-life of the radionuclide is used and whether instructions are provided to 

4 the patient before release. The following occupancy factors, E, at 1 meter, may be useful for 

5 patient-specific calculations: 

6  E = 0.75 when a physical half-life, an effective half-life, or a specific time period under 

7 consideration (e.g., bladder holding time) is less than or equal to 1 day. 

8  E = 0.25 when an effective half-life is greater than 1 day, if the patient has been given 

9 instructions, such as 

10 — Maintain a prudent distance from others for at least the first 2 days. 

11 — Sleep alone in a room for at least the first night. 

12 — Do not travel by airplane or mass transportation for at least the first day. 

13 — Do not travel on a prolonged automobile trip with others for at least the first 

14 2 days. 

15 — Have sole use of a bathroom for at least the first 2 days. 

16 — Drink plenty of fluids for at least the first 2 days. 

17  E = 0.125 when an effective half-life is greater than 1 day if the patient has been given 

18 instructions, such as 

19 — Follow the instructions for E = 0.25 above. 

20 — Live alone for at least the first 2 days. 

21 — Have few visits by family or friends for at least the first 2 days. 

22  In a two-component model (e.g., uptake of sodium iodide I-131 using thyroidal and 

23 extrathyroidal components), if the effective half-life associated with one component is 

24 less than or equal to 1 day but is greater than 1 day for the other component, it is more 

25 justifiable to use the occupancy factor associated with the dominant component for both 

26 components. 

27 Example 1: Calculate the maximum likely external dose to an individual exposed to a patient 

28 who has received 2,220 megabecquerels (MBq) [60 mCi] of sodium iodide I-131. The patient 

29 received instructions to maintain a prudent distance from others for at least 2 days, lives alone, 

30 drives home alone, and stays at home for several days without visitors. 

31 Solution: The dose to total decay (t = ∞) is calculated based on the physical half-life using 

32 Equation B–1. (This calculation illustrates the use of physical half-life. To account for biological 

33 elimination, calculations described in the next section should be used.) 
U–19 

ܦሺ∞ሻ ൌ 34.6	Γ	Q଴T୮E

rଶ

1 Because the patient has received instructions for reducing exposure as recommended for an 

2 occupancy factor of E = 0.125, the occupancy factor of 0.125 at 1 meter may be used. 

ܦሺ∞ሻ ൌ

34.6 ൬2.2	ܴ	 ∙ ܿ݉ଶ

݉ܥ݅ ∙ ݄ݎ൰ ሺ60݉ܥ݅ሻሺ8.04	݀ሻሺ0.125ሻ

ሺ100	cmሻଶ

3 D (∞) = 4.59 mSv [0.459 rem] 

4 Note that this calculation considers only the external dose to an individual from exposure to a 

5 released patient. For sodium iodide I-131, internal dose to an individual from exposure to a 

6 released patient should also be considered. See Section B.3, “Internal Dose,” for a discussion 

7 of internal dose and sample calculations. Unless the internal dose is likely to be less than 10% 

8 of the external dose, the internal and external doses must be summed to determine the 

9 total dose. 

10 If the internal dose from exposure to this patient is calculated to be less than 10% of the 

11 external dose or less than 0.41 mSv [0.041 rem], the sum of the internal and external doses is 

12 less than 5 mSv [0.5 rem]. The patient may be released, but 10 CFR 35.75(b) requires that 

13 instructions be given to the patient on maintaining doses to others ALARA. A record of the 

14 calculation must be maintained, pursuant to 10 CFR 35.75(c), because an occupancy factor of 

15 less than 0.25 at 1 meter was used. 

16 B.2 Effective Half-Life 

17 A licensee may take into account the effective half-life of the radioactive material to demonstrate 

18 compliance with the dose limits for individuals exposed to the patient that are stated in 

19 10 CFR 35.75. The effective half-life is defined as

20 Equation B–2: 

ܶ௘௙௙

ܶ௕ ൈ ܶ௣

ܶ௕ ൅	ܶ௉

21 where: Tb = Biological half-life of the radionuclide and 

22 Tp = Physical half-life of the radionuclide. 

23 The behavior of sodium iodide I-131 can be modeled using two components: extrathyroidal 

24 iodide (i.e., existing outside of the thyroid) and thyroidal iodide following uptake by the thyroid. 

25 The effective half-lives for the extrathyroidal and thyroidal fractions (i.e., F1 and F2, respectively) 

26 can be calculated with the following equations. 

27 Equation B–3:

ܶଵ௘௙௙

ܶ௕ଵ ൈ ܶ௣

ܶ௕ଵ ൅	ܶ௉
U–20 

1 Equation B–4: 

ܶଶ௘௙௙

ܶ௕ଶ ൈ ܶ௣

ܶ௕ଶ ൅	ܶ௉

2 where: Tb1 = Biological half-life for extrathyroidal iodide; 

3 Tb2 = Biological half-life of iodide following uptake by the thyroid; 

4 and 

5 Tp = Physical half-life of I-131. 

6 However, simple exponential excretion models do not account for (i) the time for the I-131 to be 

7 absorbed from the stomach to the blood; and (ii) the holdup of iodine in the urine while in the 

8 bladder. Failure to account for these factors could result in an underestimate of the dose to 

9 another individual. Therefore, this supplement makes a conservative approximation to account 

10 for these factors by assuming that, during the first 8 hours after the administration, about 80% of 

11 the iodine administered is removed from the body at a rate determined only by the physical 

12 half-life of I-131. 

13 Thus, an equation to calculate the dose from a patient administered sodium iodide I-131 may 

14 have three components. First is the dose for the first 8 hours (0.33 day) after administration. 

15 This component comes directly from Equation B–1, using the physical half-life and a factor of 

16 80%. Second is the dose from the extrathyroidal component from 8 hours to total decay. In this 

17 component, the first exponential factor represents the activity at t = 8 hours based on the 

18 physical half-life of I-131. The second exponential factor represents the activity from t = 8 hours 

19 to total decay based on the effective half-life of the extrathyroidal component. The third 

20 component, the dose from the thyroidal component for 8 hours to total decay, is calculated in 

21 the same manner as the second component. The full equation is shown as Equation B–5. 

22 Equation B–5:

23 

24 where: F1 = Extrathyroidal uptake fraction; 

25 F2 = Thyroidal uptake fraction; 

26 E1 = Occupancy factor for the first 8 hours; and 

27 E2 = Occupancy factor from 8 hours to total decay. 

28 All the other parameters are as defined in Equations B–1, B–3, and B–4. Acceptable values for 

29 F1, T1eff, F2, and T2eff are shown in Table U–6 for thyroid ablation and treatment of thyroid 

30 remnants after surgical removal of the thyroid for thyroid cancer. If these values have been 

31 measured for a specific individual, the measured values may be used. 

  



D Q

cm

ET e

e E FT e E FT

p

T

T

eff

T

eff

p

p p

 

 



 

34 6

100

08 1 0

2 1

0 693 0 33

0 693 0 33

2 11

0 693 0 33

2 22

.

( ) ( . )( ) . ( . )/

. ( . )/ . ( . )/


U–21 

1 The record of the patient’s release required by 10 CFR 35.75(c) is described in Section U.3.1 of 

2 this Appendix. 

3 Example 2, Thyroid Cancer: Calculate the maximum likely external dose to an individual 

4 exposed to a patient to whom 5,550 MBq [150 mCi] of sodium iodide I-131 have been 

5 administered for the treatment of thyroid remnants and metastasis. 

6 Solution: In this example, the dose will be calculated by using Equation B–5 to account for the 

7 elimination of I-131 from the body, based on the effective half-lives appropriate for thyroid 

8 cancer. The physical half-life and the exposure rate constant are from Table U–5. The uptake 

9 fractions and effective half-lives are from Table U–6. An occupancy factor, E, of 0.75 at 1 

10 meter, will be used for the first component because the time period under consideration is less 

11 than 1 day; however, for the second and third components, an occupancy factor of 0.25 will be 

12 used, because (i) the effective half-life associated with the dominant component is greater than 

13 1 day; and (ii) patient-specific questions were provided to the patient to justify the occupancy 

14 factor. See Section B.1.2, “Occupancy Factors to Consider for Patient-Specific Calculations,” of 

15 this Supplement. 

Table U–6. Uptake Fractions and Effective Half-Lives for Sodium-Iodide 

 Iodine-131 Treatments 

Extrathyroidal Component Thyroidal Component

Medical Condition

Uptake Fraction 

F1

Effective 

Half-Life T1eff

(day)

Uptake Fraction 

F2

Effective 

Half-Life T2eff

(day)

Hyperthyroidism 0.201* 0.322† 0.801* 5.21* 

Post-Thyroidectomy 

for Thyroid Cancer 

0.953‡ 0.322† 0.053‡ 7.32†

*M. G. Stabin et al., “Radiation Dosimetry for the Adult Female and Fetus from Iodine-131 Administration in 

Hyperthyroidism,” Journal of Nuclear Medicine, Volume 32, Number 5, May 1991. The thyroid uptake fraction of 

0.80 was selected as one that is seldom exceeded by the data shown in Figure 1 in this referenced document. The 

effective half-life of 5.2 days for the thyroidal component was derived from a biological half-life of 15 days, which was 

obtained from a straight-line fit that accounts for about 75% of the data points shown in Figure 1 of the Journal of 

Nuclear Medicine document. 

†

International Commission on Radiological Protection (ICRP) Publication No. 53, “Radiation Dose to Patients from 

Radiopharmaceuticals,” 1987. (Available for sale from Pergamon Press, Inc., Elmsford, NY 10523.) The data in that 

document suggest that the extrathyroidal component effective half-life in normal subjects is about 0.32 days. 

Lacking other data, this value is applied to hyperthyroid and thyroid cancer patients. For thyroid cancer, the thyroidal 

component effective half-life of 7.3 days is based on a biological half-life of 80 days (adult thyroid), as suggested in 

the ICRP document. 

‡

The thyroidal uptake fraction of 0.05 was recommended by Dr. M. Pollycove, M.D., NRC Medical Visiting Fellow, as 

an upper-limit post-thyroidectomy for thyroid cancer.

16 Substituting the appropriate values into Equation B–5, the dose to total decay is 

ܦሺ∞ሻ ൌ ሺ34.6ሻሺ2.2ሻሺ150ሻ

ሺ100	ܿ݉ሻଶ ሼሺ0.75ሻሺ8.04ሻሺ0.8ሻ ൬1െeି଴.଺ଽଷሺ଴.ଷଷሻ

଼.଴ସ ൰ ൅ eି଴.଺ଽଷሺ଴.ଷଷሻ଼.଴ସ ሺ0.25ሻሺ0.95ሻሺ0.32ሻ

൅	eି଴.଺ଽଷሺ଴.ଷଷሻ

଼.଴ସ ሺ0.25ሻሺ0.05ሻሺ7.3ሻሽ

17 D(∞) = 3.40 mSv [0.340 rem] 
U–22 

1 Note that this calculation considers only the external dose to an individual from exposure to a 

2 released patient. For sodium iodide I-131, internal dose to an individual from exposure to a 

3 released patient should also be considered. See Section B.3, “Internal Dose,” for a discussion 

4 of internal dose and sample calculations. Unless the internal dose is likely to be less than 

5 10% of the external dose, the internal and external doses must be summed to determine the 

6 total dose. 

7 If the internal dose from exposure to this patient is calculated to be less than 10% of the 

8 external dose or less than 1.6 mSv [0.160 rem], the sum of the internal and external doses is 

9 less than 5 mSv [0.5 rem]. This patient would not have to remain under licensee control and 

10 could be released under 10 CFR 35.75, assuming that the foregoing assumptions can be 

11 justified for the individual patient’s case and that the patient is given instructions. Patients 

12 administered somewhat larger activities could also be released immediately if the sum of the 

13 internal and external doses is not greater than 5 mSv [0.5 rem]. 

14 In the example above, the thyroidal fraction, F2 = 0.05, is a conservative assumption for persons 

15 who have had surgery to remove thyroidal tissue. If F2 has been measured for a specific 

16 patient, the measured value may be used. 

17 Example 3, Hyperthyroidism: Calculate the maximum likely external dose to an individual 

18 exposed to a patient to whom 2,035 MBq [55 mCi] of sodium iodide I-131 have been 

19 administered for the treatment of hyperthyroidism (i.e., thyroid ablation). 

20 Solution: In this example, the dose will again be calculated using Equation B–5, Table U–5, 

21 and Table U–6, to account for the elimination of I-131 from the body by using the effective 

22 half-lives appropriate for hyperthyroidism. An occupancy factor, E, of 0.25 at 1 meter will be 

23 used for the second and third components of the equation because patient-specific instructions 

24 were provided to justify the occupancy factor. See Section B.1.2, “Occupancy Factors to 

25 Consider for Patient-Specific Calculations.” 

26 Substituting the appropriate values into Equation B–5, the dose to total decay is 

ܦሺ∞ሻ ൌ ሺ34.6ሻሺ2.2ሻሺ150ሻ

ሺ100	ܿ݉ሻଶ ሼሺ0.75ሻሺ8.04ሻሺ0.8ሻ ൬1െeି଴.଺ଽଷሺ଴.ଷଷሻ

଼.଴ସ ൰ ൅ ݁ି଴.଺ଽଷሺ଴.ଷଷሻ଼.଴ସ ሺ0.25ሻሺ0.20ሻሺ0.32ሻ

൅	eି଴.଺ଽଷሺ଴.ଷଷሻ

଼.଴ସ ሺ0.25ሻሺ0.80ሻሺ5.2ሻሽ

27 D(∞) = 4.86 mSv [0.486 rem] 

28 Note that this calculation considers only the external dose to an individual from exposure to a 

29 released patient. For sodium iodide I-131, internal dose to an individual from exposure to a 

30 released patient should also be considered. See Section B.3 for a discussion of internal dose 

31 and sample calculations. Unless the internal dose is likely to be less than 10% of the external 

32 dose, the internal and external doses must be summed to determine the total dose. If the 

33 internal dose from exposure to this patient is calculated to be less than 10% of the external dose 

34 or less than 0.14 mSv [0.014 rem], the sum of the internal and external doses is less than 

35 5 mSv [0.5 rem]. The patient would not have to remain under licensee control and could be 

36 released under 10 CFR 35.75 when the occupancy factor of 0.25 in the second and third 

37 components of the equation is justified. 
U–23 

1 In the example above, the thyroidal fraction F2 = 0.8 is a conservative assumption for persons 

2 who have this treatment for hyperthyroidism. If F2 has been measured for a specific patient, the 

3 measured value may be used. 

4 B.3 Internal Dose 

5 For some radionuclides, such as sodium iodide I-131, there may be concerns that the internal 

6 dose of an individual from exposure to a released patient could be significant. A rough estimate 

7 of the maximum likely committed effective dose equivalent from internal exposure can be 

8 calculated from Equation B–6. 

9 Equation B–6: 

ܦ ௜ൌ ܳሺ10ିହሻሺܨܥܦሻ

10 where: Di = Maximum likely internal committed effective dose 

11 equivalent to the individual exposed to the patient in rem; 

12 Q = Activity administered to the patient in mCi; 

 10-5 13 = Assumed fractional intake; and 

14 DCF = Dose conversion factor to convert an intake in mCi to an 

 internal committed effective dose equivalent1 15 

Equation B–6 uses a value of 10-5 16 as the fraction of the activity administered to the patient that 

17 would be taken in by the individual exposed to the patient. A common rule of thumb is to 

18 assume that no more than 1 millionth of the activity being handled will become an intake to an 

individual working with the material. This rule of thumb2 19 was developed for cases of worker 

20 intakes during normal workplace operations, worker intakes from accidental exposures, and 

21 public intakes from accidental airborne releases from a facility, but it does not specifically apply 

to cases of intake by an individual exposed to a patient. However, two studies3,4 22 regarding the 

23 intakes of individuals exposed to patients administered sodium iodide I-131 indicated that 

24 intakes were generally of the order of 1 millionth of the activity administered to the patient and 

25 that internal doses were far below external doses. To account for the most highly exposed 

individual and to add a degree of conservatism to the calculations, a fractional transfer of 10-5 26 

27 has been assumed.

 

1

Such as tabulated in K.F. Eckerman, A. B. Wolbarst, and A. C. B. Richardson, “Limiting Values of Radionuclide 

Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submersion, and Ingestion,” Federal 

Guidance Report No.11, U. S. Environmental Protection Agency, Washington, DC, 1988. 

2

A. Brodsky, “Resuspension Factors and Probabilities of Intake of Material in Process (or ‘Is 10-6 a Magic Number in 

Health Physics?’),” Health Physics, Volume 39, Number 6, 1980

3

A. P. Jacobson, P. A. Plato, and D. Toeroek, “Contamination of the Home Environment by Patients Treated with 

Iodine-131,” American Journal of Public Health, Volume 68, Number 3, 1978. 

4

R. C. T. Buchanan and J. M. Brindle, “Radioiodine Therapy to Out-patients – The Contamination Hazard,” British 

Journal of Radiology, Volume 43, 1970. 
U–24 

1 Example 4, Internal Dose: Using the ingestion pathway, calculate the maximum internal dose 

2 to a person exposed to a patient to whom 1221 MBq [33 mCi] of sodium iodide I-131 have been 

3 administered. The ingestion pathway was selected because it is likely that most of the intake 

4 would be through the mouth or through the skin, which is most closely approximated by the 

5 ingestion pathway. 

6 Solution: This is an example of the use of Equation B–6. The dose conversion factor DCF for 

7 the ingestion pathway is 53 rem/mCi from Table 2.2 of K.F. Eckerman, A. B. Wolbarst, and 

8 A. C. B. Richardson, “Limiting Values of Radionuclide Intake and Air Concentration and Dose 

9 Conversion Factors for Inhalation, Submersion, and Ingestion,” Federal Guidance Report No.11, 

10 U. S. Environmental Protection Agency, Washington, DC, 1988. 

11 Substituting the appropriate values into Equation B–6, the maximum internal dose to the 

12 person is: 

Di = (33 mCi)(10-5 13 )(53 rem/mCi) 

14 Di = 0.17 mSv [0.017 rem] 

15 Using Equation B–1 and assuming the patient has received instructions for reducing exposure 

16 as recommended for an occupancy factor of 0.25, the external dose is approximately 5 mSv 

17 [0.5 rem]. Thus, the internal dose is about 3% of the external dose due to gamma rays. Internal 

18 doses may be ignored in calculations of total dose, if they are likely to be less than 10% of the 

19 external dose because the internal dose due to this source is small in comparison to the 

20 magnitude of uncertainty in the external dose. 

21 The conclusion that internal contamination is relatively unimportant in the case of patient 

22 release was also reached by the NCRP. The NCRP addressed the risk of intake of 

23 radionuclides from patients’ secretions and excreta in NCRP Commentary No. 11, “Dose Limits 

24 for Individuals Who Receive Exposure from Radionuclide Therapy Patients.” The NCRP 

25 concluded, “Thus, a contamination incident that could lead to a significant intake of radioactive 

26 material is very unlikely.” For additional discussion on the subject, see NUREG–1492. 

27 Example 5, Internal Dose: Calculate the maximum internal dose to a person exposed to a 

28 patient to whom 5,550 MBq [150 mCi] of sodium iodide I-131 have been administered for the 

29 treatment of thyroid remnants and metastasis. 

30 Solution: In this example, the dose is again calculated using Equation B–6 and selecting the 

31 ingestion pathway. Substituting the appropriate values into Equation B–6, the maximum internal 

32 dose to the person is 

Di = (150 mCi)(10-5 33 )(53 rem/mCi) 

34 Di = 0.80 mSv [0.08 rem] 

35 In this case, the external dose to the other person from Example 2, Thyroid Cancer, was 

36 approximately 3.4 mSv [0.34 rem], while the internal dose would be about 0.80 mSv [0.08 rem]. 

37 Thus, the internal dose is about 24% of the external gamma dose. Therefore, the internal and 

38 external doses must be summed to determine the total dose: 4.2 mSv [0.42 rem]. 
U–25 

1 Other Reference Documents 

2  American National Standards Institute (ANSI) N13.54, “Fetal Radiation Dose 

3 Calculations,” January 2008. 

4  ICRP Publication No. 53, “Radiation Dose to Patients from Radiopharmaceuticals,” 

5 1987. 

6  ICRP Report No. 80, “Radiation Dose to Patients from Radiopharmaceuticals 

7 (Addendum to ICRP Publication 53)”, 1998. 

8  ICRP Report No. 106, “Radiation Dose to Patients from Radiopharmaceuticals 

9 (Addendum 3 to ICRP Publication 53),” 2008. 

10  NCRP Report No. 128, “Radionuclide Exposure of the Embryo/Fetus,” 1998. 

11  Regulatory Guide (RG) 8.39, “Release of Patients Administered Radioactive Materials,” 

12 April 1997. 

13 Regulatory Analysis 

14  NUREG–1492, “Regulatory Analysis on Criteria for the Release of Patients Administered 

15 Radioactive Material,” February 1997, provides the regulatory basis and examines the 

16 costs and benefits. 

1 APPENDIX V 

2 RADIOACTIVE MATERIALS GUIDANCE FOR MOBILE MEDICAL SERVICES 

V–1 

1 Radioactive Materials Guidance for Mobile Medical Services 

2 Before submitting information to the U.S. Nuclear Regulatory Commission (NRC), review 

3 Chapter 6, “Identifying and Protecting Sensitive Information,” of this document for guidance on 

4 identifying and protecting sensitive information. All security-related sensitive information in the 

5 application should be identified and properly marked. 

6 Mobile medical service providers must comply with all applicable sections of Title 10 of the 

7 Code of Federal Regulations (10 CFR) 10 CFR Part 30 and 35 as well as U.S. Department of 

8 Transportation (DOT) regulations regarding approved source holders, placement of sources in 

9 approved containers prior to their transport, and hazardous materials training. For example, 

10 mobile medical service providers offering remote afterloaders must comply with 10 CFR Part 35, 

11 Subpart H. The sections below describe the type of information that should be submitted when 

12 requesting to conduct mobile medical service provider activities. 

13 Type and Location of Use 

14 In general, there are two types of mobile medical service. One type is transportation and use of 

15 byproduct material within a transport vehicle (e.g., in-van or trailer use). A second type is 

16 transportation of byproduct material to a client’s facility for use within a client’s facility by either 

17 the mobile medical service’s employees (i.e., transport and use) or the client’s employees 

18 (i.e., transport only). 

19 For the first and second types, which include use by the service provider, the service provider 

20 should apply for full service authorization. Service providers who only transport and store a 

21 therapy device need only apply for authorization for possession and transport of the byproduct 

22 material. In this case, when the service provider is only transporting the therapy device for use, 

23 the client must possess a license for medical use of the byproduct material. Additionally, in this 

24 case, the client is authorized to provide the patient treatments and is responsible for all aspects 

25 of the byproduct material use and patient treatments upon transfer of the byproduct material to 

26 the client’s possession. 

27 A Positron Emission Tomography (PET) mobile medical service provider that uses a “quiet 

28 room” and/or a patient waiting area in the client’s facility may either be authorized for “in-van or 

29 trailer use only” or “transport and use,” depending on whether the PET patients meet the criteria 

30 for release described in 10 CFR 35.75 while they are in the “quiet room.” If they do not, then the 

31 “quiet room” is an area of use for the mobile medical service licensee and should be under their 

32 control while onsite. In addition, for mobile nuclear medicine and PET imaging, the licensee 

33 should take into account the possibility of using the client’s bathroom dedicated for their use for 

34 PET patients and finding the bathroom with low levels of radioactive contamination during the 

35 end-of-day surveys. In this event, the mobile licensee must provide direction to the client for 

36 restricting access to the bathroom until follow up surveys show the bathroom free of 

37 contamination (e.g., post and close off the patient bathroom for a designated period of time to 

38 allow for radioactive decay). The mobile medical service provider should also survey “quiet 

39 rooms,” provided for their use at the client’s site, for contamination and radiation levels to 

40 ensure that public dose limits are not exceeded and that these areas are left free of 

41 contamination following use. 

42 The locations of use for mobile medical services are of two basic types. One type of location is 

43 the base location where licensed material is received, stored, and sometimes used. The other 
V–2 

1 type of location is the temporary jobsite at client facilities. The following two sections describe 

2 the type of information necessary for base locations and temporary jobsites. 

3 Mobile Medical Service Agreement 

4 Regulations in 10 CFR 35.80(a)(1) require, in part, that a licensee providing mobile medical 

5 service shall obtain a letter signed by the management of each client for which services are 

6 rendered that permits the use of byproduct material at the client’s address and clearly 

7 delineates the authority and responsibility of the licensee and the client. This agreement must 

8 be applicable for the entire period of time over which the service is to be provided. The letter 

9 will be retained for 3 years after the last provision of service, as required by 10 CFR 35.80(c) 

10 and 10 CFR 35.2080, “Records of mobile medical services.” Additionally, as required by 

11 10 CFR 35.80(a)(4), the licensee must survey to ensure compliance with the requirements in 

12 10 CFR Part 20 (e.g., ensure that all byproduct material, including radiopharmaceuticals, sealed 

13 sources, and all associated wastes, have been removed) before leaving a client’s address. 

14 The following is provided as an example of a PET mobile medical service agreement. 

15 SAMPLE PET MOBILE MEDICAL SERVICE AGREEMENT 

16 In accordance with 10 CFR 35.80(a)(1), management designee, Sam Curie of ABC Hospital, 

17 Inc. acknowledges that mobile medical service provider, PET Mobile, Inc., will use byproduct 

18 material at client address 456 Rad Road, Somewhere, WV. Service will be provided every 

19 Monday beginning February 1, 2014. All radioactive material will be removed from the client 

20 facility prior to leaving the site. PET Mobile, Inc. will abide by all NRC and Agreement State 

21 regulations while on-site. 

22 The following authority and responsibilities are delegated to the client: 

23  ordering of radioactive dosages 

24 The following authority and responsibilities are delegated to the mobile medical service provider: 

25  Package receipt and return surveys. 

26  Quality control testing on equipment used to measure radioactive dosages 

27 (e.g., dose calibrator). 

28  Quality control testing and calibration of survey instrumentation (e.g., radiation survey 

29 meter, well counter). 

30  Sealed source inventories and leak testing. 

31  Shipping papers. 

32  Radiation safety and hazardous materials (HAZMAT) training for mobile medical service 

33 personnel. 

34  Radiation safety training for client staff involved in: (i) controlling patient waiting areas 

35 used by the mobile medical service provider in the hospital; (ii) performing surveys to 
V–3 

1 support release of the patient bathroom located in the hospital; and (iii) providing 

2 patient escort. 

3  Surveys of all interior PET trailer areas. 

4  Surveys of areas exterior to the PET trailer to ensure compliance with 10 CFR 20.1301

5 and roping off of any area (if necessary) to ensure that the dose rate is less than 0.02 

6 mSv [2 millirem (mrem)] in any one hour. 

7  Surveys of patient waiting area in the hospital to ensure compliance with 

8 10 CFR 20.1301 (0.02 mSv [2 mrem] in any one hour and 1 mSv [0.1 rem] in a year) 

9 since the patient has not yet been released under 10 CFR 35.75 and is awaiting 

10 scanning. 

11  Surveys of dedicated PET patient bathroom located within the hospital prior to leaving 

12 client site. 

13  Decay in storage and disposal of radioactive material/waste. Radioactive waste will be 

14 removed to the PET trailer for storage. Non-radioactive waste that has been surveyed 

15 and shown to be at background may be disposed into the normal waste stream at the 

16 client’s site. 

17  Confirming that AUs designated on the application are cognizant that they will be 

18 responsible for supervising the use of licensed material. 

19  Providing dosimetry to staff that would require it in accordance with 10 CFR 20.1502.

20  Maintaining security of mobile PET trailer (e.g. keys, keypad codes). 

21  Ensuring that all radioactive material is accounted for and removed from the client at the 

22 end of the day of service. 

23  Radiation safety program audits, including use at client sites, in accordance with 

24 10 CFR 20.1101. 

25 Note: In the event that bathroom contamination is found in the dedicated PET bathroom on 

26 hospital property and cannot be cleaned to below trigger levels for an unrestricted area, the 

27 mobile medical service provider will block off the bathroom and post it as a radiation area. The 

28 contamination will be reported to the client manager. The bathroom will be surveyed with a 

29 calibrated radiation survey meter the next day and released for unrestricted use if radiation 

30 levels are below trigger levels for an unrestricted area described in the mobile medical service 

31 provider license. 

32 This agreement will be retained by the licensee for 3 years after the last provision of service, in 

33 accordance with 10 CFR 35.2080. 

34 ___________________________ _____________________________ 

35 Signed and Dated Signed and Dated 

36 Vice President of Operations President 

37 ABC Hospital PET Mobile, Inc. 
V–4 

1 Base Location 

2 The base location (e.g., nuclear medicine hot lab or storage location for the remote afterloader) 

3 for the mobile medical service must be specified. A “base location” is one that is identified on 

4 the license, while a “temporary jobsite” (or client site) is a location that is other than a location of 

5 use identified on the license and where work is conducted for a limited period of time. The base 

6 location can be in a medical institution, noninstitutional medical practice, commercial facility, or 

7 mobile van or trailer. Applicants should specify in what type of facility the proposed base 

8 location is sited. A mobile licensee cannot provide a service to a private practice (nonlicensee) 

9 located within a licensed medical institution (e.g., hospital). The medical institution’s 

10 management (i.e., hospital management) must be consulted in this event. As required by 

11 10 CFR 30.33 and 10 CFR 35.12, applicants must submit a description and diagram(s) of the 

12 proposed base location and associated equipment in accordance with Item 9 of this report. The 

13 description and diagram of the proposed base location should demonstrate that the building (or 

14 van or trailer) is of adequate construction and design to protect its contents from the elements 

15 (e.g., high winds, rain), ensures security of licensed material to prevent unauthorized access 

16 (e.g., control of keys), and ensures that radiation levels in unrestricted areas are in compliance 

17 with 10 CFR 20.1301 (e.g., shielding and roping off of areas greater than 0.02 mSv [2 mrem] in 

18 any one hour). Include a diagram showing the location of the licensed material, receipt, and use 

19 areas, and identify all areas adjacent to restricted areas, including areas above and below the 

20 restricted areas. For storage locations within a van or trailer, the description of the van or trailer 

21 should address radiation levels in the van or trailer driver’s compartment to demonstrate 

22 compliance with 10 CFR 20.1201, “Occupational dose limits for adults.” 

23  Applicants may request multiple base locations. Radioactive material must be delivered 

24 only to a facility licensed to receive the type of radioactive material ordered. 

25 — For diagnostic uses, the mobile medical service provider may list a portion of a 

26 client’s site as a base location for which there is a clear written agreement with 

27 the facility owner addressing security against unauthorized removal and 

28 establishing responsibility for the licensed material. This agreement should 

29 indicate the receipt and storage location and confirm that the mobile medical 

30 service provider will have sole access to the receipt/storage location and will be 

31 granted access to the facilities to remove any licensed material or decontaminate 

32 the facility, as necessary. In this case, the mobile medical service provider may 

33 arrange to have licensed material delivered to the base location without their 

34 personnel present. 

35  Base locations can include the use of a mobile van or trailer. When the base location is 

36 in the van or trailer, and there is no permanent structure for the byproduct material 

37 storage, provide for the following: 

38 — Secured off-street parking is under licensee control. Public rights-of-way are not 

39 considered part of the address of the client. 

40 — Secured storage facilities are available for storage of byproduct material and 

41 radioactive waste if the van or trailer is disabled. 

42  Byproduct material is delivered directly to the van or trailer parked at a site owned by the 

43 mobile medical service provider occupied by licensee personnel. In addition, for 

44 diagnostic uses only, the mobile medical service provider may arrange to have licensed 
V–5 

1 material delivered to the van or trailer parked at a client site only if the mobile medical 

2 service provider submits information clearly demonstrating that they will have their 

3 personnel at the van or trailer to accept delivery and ensure the security and control of 

4 the licensed material. 

5  The mobile medical service provider may list a portion of a client’s site as a base 

6 location for which there is a clear written agreement with the facility owner addressing 

7 security against unauthorized removal and establishing responsibility for the licensed 

8 material. This agreement should indicate the receipt and storage location and confirm 

9 that the mobile medical service provider will have sole access to the receipt/storage 

10 location and will be granted access to the facilities to remove any licensed material or 

11 decontaminate the facility, as necessary. In this case, the mobile medical service 

12 provider may arrange to have licensed material delivered to the base location without 

13 their personnel present. 

14  If a base location is in a residential area, provide the following information: 

15 — Justification of the need for a private residence location rather than for a 

16 commercial location. 

17 — Documentation of the agreement between the residence owner and the licensee. 

18 It is essential that the mobile medical service have access to the base location in 

19 the event of contamination. Provisions for decontamination of the mobile medical 

20 service van or trailer, etc., on the client property (if necessary) will be included. 

21 Documentation from both parties will illustrate the agreement between the client 

22 and the mobile medical service. 

23 — A description of the program demonstrating compliance with 10 CFR 20.1301, 

24 “Dose limits for individual members of the public.” 

25 — Verification that restricted areas do not contain residential quarters. 

26  Perform surveys necessary to show that exposure rates do not exceed 0.02 mSv [2 

27 mrem] in any one hour nor 1 mSv/yr [100 mrem/yr]. 

28 Client Site for Diagnostic Uses 

29 In general, client facility information does not need to be submitted; however, the mobile 

30 medical service provider may arrange to have licensed material delivered to the client site only if 

31 the licensee submits information clearly demonstrating that the mobile medical service provider 

32 licensee will have its own personnel at the client site to accept delivery and ensure the security 

33 and control of the licensed material. 

34 Alternatively, the mobile medical service provider may list a portion of a client’s site as a base 

35 location for which there is a clear written agreement with the facility owner addressing security 

36 against unauthorized removal and establishing responsibility for the licensed material. This 

37 agreement should indicate the receipt and storage location and confirm that the mobile medical 

38 service provider will have sole access to the receipt/storage location and will be granted access 

39 to the facilities to remove any licensed material or decontaminate the facility, as necessary. In 

40 this case, the mobile medical service provider may arrange to have licensed material delivered 
V–6 

1 to the base location without their personnel present and must provide an example contract that 

2 will be used with clients to designate these areas. 

3 In addition, as described above, the client may designate “quiet rooms” for use by PET mobile 

4 medical service providers. These areas must also be described in the contract with the client 

5 and the applicant must provide an example contract that will be used with clients to designate 

6 these areas. 

7 Client Site for Therapeutic Uses 

8 This section applies only to therapeutic uses of byproduct material. For all types of therapy 

9 uses, the medical institutions, hospitals, or clinics and their addresses that comprise the client 

10 sites for mobile medical services must be listed. 

11 For self-contained byproduct material services (e.g., in-van or trailer), the following additional 

12 facility information should be provided: 

13  For therapy treatments with byproduct material [e.g., high dosage-rate (HDR) remote 

14 afterloader], provide a separate drawing for each client site showing the location of the 

15 treatment device and vehicle in relation to all nearby roads, sidewalks, structures, and 

16 any other locations accessible by members of the public. 

17  As delineated in the letter required by 10 CFR 35.80(a), a signed agreement that the 

18 location of the treatment device and vehicle will be on client-owned or controlled 

19 property. 

20  The protection from vehicular traffic that could adversely affect patient treatment(s), 

21 which could be accomplished either by locating the facility away from all vehicular traffic 

22 or by using barriers. Any protective measures must be shown on the facility or site 

23 drawings provided. 

24  A description of the emergency lighting system that automatically activates on detection 

25 of the loss of primary power during patient remote afterloader treatments. The system 

26 must provide sufficient light to perform any possible emergency procedures, including 

27 the removal of a detached or stuck source that remains within the patient. 

28 If transportable services will be provided to the client’s site for use within the client’s facility by 

29 the mobile medical service’s employees, the following client facility information and commitment 

30 should be provided: 

31  A detailed description and diagram(s) of the proposed use facility (e.g., client site) and 

32 associated equipment in accordance with Items 8.14 through 8.19 of this report. The 

33 description and diagram of the proposed use facility must demonstrate that the facility is 

34 of adequate construction and design to protect its contents from the elements (e.g., high 

35 winds, rain), ensure security of licensed material to prevent unauthorized access, and 

36 ensure that radiation levels in unrestricted areas are in compliance with 

37 10 CFR 20.1301. Include a diagram showing the location of the equipment, receipt, and 

38 use areas, and identify all areas adjacent to restricted areas. 
V–7 

1  A commitment, as delineated in the letter required by 10 CFR 35.80(a), that the mobile 

2 medical service licensee has full control of the treatment room during byproduct material 

3 use for each client. 

4  The initial installation records and function checks of a remote afterloader device for 

5 each site of use, as required by 10 CFR 35.633, “Full calibration measurements on 

6 remote afterloader units;” 10 CFR 35.643, “Periodic spot-checks for remote afterloader 

7 units;” and 10 CFR 35.647, “Additional technical requirements for mobile remote 

8 afterloader units.” 

9 For a transport-only mobile medical service for therapy devices that are transported to the 

10 client’s facility, used by the client’s staff (under their own license), and removed by the service 

11 provider, ensure the following: 

12  Each client is properly licensed for medical use of byproduct material (which now also 

13 includes accelerator-produced radioactive materials and discrete sources of 

14 radium-226). If applicable, licensees should ensure that each client has received the 

15 necessary initial and, if appropriate, recurrent training for the specific make and model of 

16 the remote afterloader device being provided. If the above applicable conditions are not 

17 met, the mobile medical service licensee must not transfer the remote afterloader device 

18 to the client. 

19  No signed agreement with a client may state or imply any assumption of responsibility 

20 on the part of the mobile medical service for the use of byproduct material for patient 

21 treatments. This includes such activities as dosage measurements, source calibrations, 

22 and remote afterloader device operational checks. Although these and other services 

23 may be provided to the client by the mobile medical service if the mobile medical service 

24 is specifically licensed to provide such services, the client (licensee) retains all of the 

25 responsibilities related to the use of the byproduct material for patient treatments. The 

26 responsibilities for supervising individuals who use the byproduct material, set forth in 

27 10 CFR 35.27, “Supervision,” transfer to the client’s authorized users (AU) upon transfer 

28 of the device to the client by the mobile medical service provider. 

29  The initial installation of a remote afterloader device at the client site may be performed 

30 by either the mobile medical service provider or the client, but all device function checks 

31 are the responsibility of the client (i.e., the licensee authorized to provide patient 

32 treatments at the client site). 

33  As required by 10 CFR 30.51, “Records,” a formal record of the transfer of control of the 

34 byproduct material from the mobile medical service provider to the client, and from the 

35 client back to the mobile medical service provider, must be made for each transfer of 

36 byproduct material. A signed receipt of each transfer must be made and retained for 

37 inspection for 3 years. 

38 Supervision 

39 In addition to the requirements in 10 CFR 19.12, 10 CFR 35.27 requires that instructions be 

40 given to supervised individuals in written radiation protection procedures, written directive 

41 
V–8 

1 procedures, regulations, and license conditions with respect to the use of byproduct material. 

2 Additionally, 10 CFR 35.27 requires the supervised individual to: 

3  Follow the instructions of the supervising AU for medical uses of byproduct material. 

4  Follow the instructions of the supervising Authorized Nuclear Pharmacist or supervising 

5 AU for preparation of byproduct material for medical uses. 

6  Follow the written radiation protection procedures and written directive procedures 

7 established by the licensee. 

8  Comply with the provisions of 10 CFR Part 35 [e.g., 10 CFR 35.80 and 10 CFR 35.647

9 (if applicable)], and the license conditions with respect to the mobile medical use of 

10 byproduct material. 

11 Training for Individuals Working in or Frequenting Restricted Areas 

12 Drivers and technologists (or therapists) will be properly trained in applicable transportation 

13 regulations and emergency procedures in addition to the training requirements of 10 CFR 19.12, 

14 10 CFR 35.27, 10 CFR 35.310, 10 CFR 35.410, and 10 CFR 35.610 (as applicable). The 

15 training for these individuals will include, at a minimum, DOT regulations, shielding, as low as is 

16 reasonably achievable (ALARA), basic radiation protection, and emergency response. 

17 Survey Instrument and Dose Measurement Instrument Checks 

18 As required by 10 CFR 35.80, instruments should be checked for proper operation before use at 

19 each address of use. Dosage measurement instruments should be checked before medical use 

20 at each address of use or on each day of use, whichever is more frequent. Additionally, all 

21 other transported equipment (e.g., cameras) should be checked for proper function before 

22 medical use at each address of use. 

23 Order and Receipt of Byproduct Material 

24 Byproduct material will be delivered by a supplier to the base location or to the client’s address if 

25 the client is licensed to receive the type of byproduct material ordered. Additionally, if the 

26 mobile medical service provider is specifically licensed for receipt and storage in the client’s 

27 facility, byproduct material may be delivered to the client’s address. Delivery of byproduct 

28 material to a van or trailer that is not occupied by the mobile medical service personnel will not 

29 be permitted. 

30 Alternatively, licensees may pick up the byproduct material (e.g., radiopharmaceuticals) from 

31 the supplier (e.g., nuclear pharmacy) en route to client facilities. 

32 Emergency Procedures 

33 The mobile medical service provider applicant should commit to develop, implement, and 

34 maintain emergency procedures, in accordance with the radiation protection program required 

35 by 10 CFR 20.1101. Indicate typical response times of the radiation safety officer (RSO) and 

36 AU in the event of an incident, and develop and implement procedures that include emergency 

37 response regarding an accident scenario. An accident is defined as a vehicle collision or other 

38 event, such as wind, water, or fire that results in damage to exterior or interior portions of the 
V–9 

1 vehicle or the byproduct material used in the mobile medical service. The transportation 

2 emergency response plan should cover both the actions to be taken by the mobile medical 

3 service provider’s headquarters emergency response personnel and the “on-scene” 

4 hazardous-material (HAZMAT)-trained personnel, and it will be readily available to both 

5 transport vehicle personnel and headquarters emergency-response contacts. The plan should 

6 include the following: 

7  A 24-hour emergency contact telephone number for the mobile medical service 

8 provider’s emergency response personnel. 

9  The emergency contact numbers for the NRC’s Operation Center and all appropriate 

10 State radiological protection agencies. 

11  Procedures for restricting access to the transport vehicle until surveys have been made 

12 to determine if any radiological hazards exist. 

13  Procedures for retrieving and securing any byproduct material, including a sealed source 

14 that may become detached or dislodged to the extent that a radiological hazard is 

15 created, which may require one or more emergency shielded source containers. 

16  Predetermined (calculated) exposure rates for an unshielded therapy source 

17 (if applicable) as a function of distance for use in controlling the exposures of emergency 

18 response personnel to the maximum extent possible under various emergency 

19 response scenarios. 

20  Preplanned decontamination procedures, including ready access to all 

21 necessary materials. 

22  A calibrated, operational radiation survey meter maintained in the cab of the transporting 

23 vehicle, which may be used at an accident scene for conducting surveys. 

24  Security of the transport vehicle against unauthorized access, including the 

25 driver’s compartment. 

26  Procedures to ensure that following any accident, no patient treatments with remote 

27 afterloaders will occur until all systems pertaining to radiation safety have been tested 

28 and confirmed to be operational by the RSO or authorized medical physicist. If any 

29 problem is found, including remote afterloader device interlocks and operation, the 

30 remote afterloader device or facility will be repaired and re-certified by the device vendor 

31 prior to return to service. In addition, a copy of the report, generated in accordance with 

32 10 CFR 30.50, “Reporting requirements,” will be provided to clients following any 

33 accident in which there is actual or possible damage to the client’s facility or the device. 

34 Note: The type of response should be consistent with the level of the incident. The response 

35 may range from telephone contact for minor spills to prompt onsite response (less than 3 hours) 

36 to events such as a medical event or lost radioactive material. 

37 
V–10 

1 Transportation 

2 The mobile medical service provider applicant should commit to develop, document, and 

3 implement procedures to assure that the following takes place: 

4  Radioactive material is transported in accordance with 49 CFR Parts 170–178, 

5 “Transportation.” Procedures will include 

6 — use of approved packages 

7 — use of approved labeling 

8 — conduct of proper surveys 

9 — complete and accurate shipping papers 

10 — bracing of packages 

11 — security provisions 

12 — written emergency instructions 

13  Management (or management’s designee) will perform audits, at least annually, of 

14 transportation documentation (e.g., shipping papers and survey reports) and activities at 

15 client facilities. 

16  Licensed material is secured during transport and use at the client’s facilities. 

17  Radioactive waste is handled properly during transport. Describe the method of storage 

18 and final disposal. 

19  The transport vehicle, including the driver’s compartment, if separate, will be secured at 

20 all times from any unauthorized access when the vehicle is unattended. 

21 Note: The necessary DOT Type 7A package certification for remote afterloader devices is 

22 established by prior approval of the appropriate sealed source and device sheets; however, if 

23 the remote afterloader device is damaged in any way during use or transport, then the integrity 

24 of the DOT Type 7A packaging may be compromised, and the device must not be used or 

25 transported until checked by the vendor and certified as retaining its integrity as a 

26 Type 7A package. 

27 Appendix Z of this NUREG summarizes DOT requirements for Transportation of 

28 Licensed Material.

29 Radioactive Waste Management 

30 If waste will be stored in vans or trailers, they must be properly secured and posted as 

31 byproduct material storage locations. Ensure that the van or trailer will be secured against 

32 unauthorized access and that the waste storage location will be posted as a byproduct material 

33 storage area. 

34 Develop, document, and implement final waste disposal procedures in accordance with 

35 Section 8.11 of this report. 

36 Excreta from individuals undergoing medical diagnosis or therapy with radioactive material may 

37 be disposed of without regard to radioactivity if it is discharged into the sanitary sewer system, 

38 in accordance with 10 CFR 20.2003. However, collecting excreta from patients in a van or 
V–11 

1 trailer restroom with a holding tank is not considered direct disposal into the sanitary sewer 

2 system. If restroom facilities are provided in the van or trailer for patient use, submit the 

3 following information for NRC review: 

4  A description of the structure of the tank holding facility and the location of the tank in 

5 relation to members of the public, workers in the van or trailer, and the driver of the van 

6 or trailer; a description of procedures to assess the tank for possible leakage; and a 

7 description of any restroom ventilation if any iodine-131 will be held in the tank. 

8  A description of procedures to ensure doses to occupational workers and members of 

9 the public will not exceed the exposure limits in 10 CFR 20.1201 and 20.1301, that the 

10 external surfaces of the van or trailer do not exceed 0.02 mSv/h [2 mrem/h], and that 

11 doses to members of the public and workers are maintained ALARA, including 

12 considerations of external dose rates in the restroom caused by the proximity of the 

13 holding tank to the toilet. 

14  A description of procedures for emptying and disposing of the contents of the holding 

15 tank, including the frequency of disposal, who empties the tank into the sanitary sewer 

16 system, and the location of disposal into the sanitary sewer, including precautions taken 

17 to minimize contamination in this process. 

18 Mobile Medical Services With Remote Afterloader Devices 

19 Because the movement of the remote afterloader device from one location to another increases 

20 the risk of electro-mechanical component failures or misalignments, it is important that the 

21 proper operation of the device be fully checked after each such relocation. Therefore, develop, 

22 document, and implement the following procedures to determine if a device is operating 

23 properly before the commencement of patient treatments: 

24  Conduct safety checks on a remote afterloader device and facility. The procedure will 

25 include the periodic spot-checks required by 10 CFR 35.643 and the additional 

26 spot-checks required by 10 CFR 35.647 before use at each address of use. 

27 Additionally, the procedure should include provisions for prompt repair of any system not 

28 operating properly. 

29  The pretreatment operational function checks after each device move should include a 

30 review of any device alarm or error message and, if necessary, a resolution of problems 

31 indicated by such messages. 

32  Such tests should be performed in accordance with written procedures. 

33  As required by 10 CFR 35.2647 and 10 CFR 35.2643, records showing the results of the 

34 above safety checks must be maintained for NRC inspection and review for a period of 

35 3 years. 

36  Perform surveys of the source housing and areas adjacent to the treatment room 

37 following relocation of an HDR unit. These surveys should include the source housing 

38 with the source in the shielded position and all areas adjacent to the treatment room with 

39 the source in the treatment position.

1 APPENDIX W 

2 MODEL PROCEDURES FOR WASTE DISPOSAL BY DECAY-IN-STORAGE, 

3 GENERATOR RETURN, AND LICENSED MATERIAL RETURN 

W–1 

1 Model Procedures for Waste Disposal by Decay-In-Storage, Generator 

2 Return, and Licensed Material Return 

3 This model provides acceptable procedures for waste disposal. Most licensees will dispose of 

4 material that fall within these procedures. Note that some short half-life radionuclide products 

5 [e.g., technetium-99m (Tc-99m)/molybdenum-99 (Mo-99) generator columns and some 

6 yttrium-90 (Y-90) microspheres] may contain long half-life contaminants that may preclude 

7 disposal by decay-in-storage and may require disposal by alternate methods, such as return to 

8 the manufacturer. Applicants may either adopt these model procedures or develop alternative 

9 procedures to meet the requirements of Subpart K, “Waste Disposal,” to Title 10 of the Code of 

10 Federal Regulations (CFR) 10 CFR Part 20, 10 CFR 20.1101, and 10 CFR 35.92. 

11 Model Procedure for Decay-In-Storage 

12 Regulations in 10 CFR 35.92 describe the requirements for decay-in-storage. Applicants should 

13 ensure that adequate space and facilities are available for the storage of waste for decay-in14 storage (DIS). Storage should be designed to allow for segregation of wastes with different 

15 half-lives (e.g., multiple shielded containers). Containers should have shielded covers to 

16 maintain occupational exposure at as low as is reasonably achievable levels. Storage areas 

17 must be in a secure location. 

18  Only short-lived waste (physical half-life of less than or equal to 120 days) may be 

19 disposed of by DIS. 

20  Waste should be stored in suitable well-marked containers, and the containers should 

21 provide adequate shielding. 

22  Store liquid and solid wastes should be stored separately.

23  If possible, use separate containers for different types of waste (e.g., needles and 

24 syringes in one container, other injection paraphernalia such as swabs and gauze in 

25 another, and unused dosages in a third container). Because the waste will be surveyed 

26 with all shielding removed, the containers in which the waste will be placed must not 

27 provide any radiation shielding for the material. 

28  When the container is full, seal it and attach an identification tag that includes the date 

29 sealed and the longest-lived radionuclide in the container. 

30  The identification label should include the date when the container was sealed, the 

31 longest-lived radionuclide in the container. The container should be labeled in 

32 accordance with 10 CFR 20.1904 and 10 CFR 20.1905. The container may be 

33 transferred to the DIS area. When large quantities are held for DIS, sufficient quantities 

34 may be present even after many half-lives and persons performing surveys should be 

35 aware of the potential for measurable radiation. 

36  The contents of the container should be allowed to decay for a period of time after which 

37 it is expected that the radiation levels would not be distinguishable from background. 

38 The period of time depends on both the half-life of the radionuclide(s) and the original 

39 amount present. 
W–2 

1  Prior to disposal as in-house waste, monitor and record the results of monitoring of each 

2 container as follows: 

3 — Use a survey instrument that is appropriate for the type and energy of the 

4 radiation being measured. 

5 — Check the radiation survey meter for proper operation and current 

6 calibration status. 

7 — Monitor in a low-level radiation area away from all sources of radioactive 

8 material, if possible. 

9 — Remove any shielding from around the container or generator column. 

10 — Monitor, at contact, all surfaces of each individual container. 

11 — Remove or deface any radioactive material labels (unless the containers will be 

12 managed as biomedical waste after they have been released from the licensee 

13 as described in 10 CFR 35.92). 

14 — Discard as in-house waste only those containers that cannot be distinguished 

15 from background radiation. Containers may include trash bags full of waste, 

16 generator columns, and biohazard (needle) boxes. Record the disposal date, the 

17 survey instrument used, the background dose rate, the dose rate measured at 

18 the surface of each waste container, and the name of the individual who 

19 performed the disposal. 

20 — Containers that can be distinguished from background radiation levels must be 

21 returned to the storage area for further decay or transferred to an authorized 

22 byproduct material recipient. 

23 — Short half-life radionuclide products such as samarium-153 (Sm-153), 

24 Tc-99m/Mo-99 generator columns, and Y-90 microspheres may contain long 

25 half-life contaminants that may preclude disposal by decay-in-storage. 

26 Licensees need to perform surveys and dispose of long half-life contaminants in 

27 accordance with 10 CFR Parts 20 and 35 requirements. 

28 Note: Check for any calibration sources with half-lives greater than 120 days (e.g., cobalt-57, 

29 germanium-68, gadolinium-153), as these may not be held for decay-in-storage and must be 

30 disposed of in accordance with 10 CFR Part 20 and 10 CFR Part 30. 

31 Model Procedure for Returning Generators to the Manufacturer 

32 Used Mo/Tc-99m, strontium-82/rubidium-82, or germanium-68/gallium-68 generators may be 

33 returned to the manufacturer. This permission does not relieve licensees from the requirement 

34 to comply with 10 CFR Part 71 and U.S. Department of Transportation (DOT) regulations. 

35 Perform the following actions when returning generators: 

36  Retain the records needed to demonstrate that the package qualifies as a DOT 

37 Specification 7A container. 
W–3 

1  Assemble the package in accordance with the manufacturer’s instructions. 

2  Perform the dose-rate and removable-contamination measurements. 

3  Label the package and complete the shipping papers in accordance with the 

4 manufacturer’s instructions. 

5  Retain records of receipts and transfers in accordance with 10 CFR 30.51, “Records.”

6 Model Procedure for Return of Licensed Material to Authorized Recipients 

7 Perform the following steps when returning licensed material to authorized recipients: 

8  In accordance with 10 CFR 30.41(a)(5), confirm that persons are authorized to receive 

9 byproduct material prior to transfer (e.g., obtain a copy of the transferee’s U.S. Nuclear 

10 Regulatory Commission license or Agreement State license that authorizes the 

11 byproduct material). 

12  Retain the records needed to demonstrate that the package qualifies as a DOT 

13 Specification 7A container. 

14  Assemble the package in accordance with the manufacturer’s instructions. 

15  Perform the dose-rate and removable-contamination measurements. 

16  Label the package and complete the shipping papers in accordance with the 

17 manufacturer’s instructions. 

18  Retain records of receipts and transfers in accordance with 10 CFR 30.51.

19 Model Procedure for Disposal of Liquids into Sanitary Sewerage 

20  Confirm that the sewer system is a public system, not a private sanitary sewer, septic 

21 system or leach field. 

22  Confirm that the liquid waste being discharged is soluble (or is biological material that is 

23 readily dispersible) in water. 

24  Calculate the amount of each radionuclide that can be discharged by using the 

25 information from prior, similar discharges and the information in 10 CFR Part 20, 

26 Appendix B. 

27  Make sure that the amount of each radionuclide does not exceed the monthly and 

28 annual discharge limits specified in 10 CFR 20.2003(a)(4) and 10 CFR Part 20, 

29 Appendix B, Table 3. 

30  If more than one radionuclide is released, the sum of the ratios of the average monthly 

31 discharge of a radionuclide to the corresponding limit in 10 CFR Part 20, Appendix B, 

32 Table 3 must not exceed unity. 
W–4 

1  Confirm that the total quantity of licensed material released into the sanitary sewerage 

2 system in a year does not exceed 185 gigabecquerel (GBq) [5 Curies (Ci)] of H-3 

3 (tritium), 37 GBq [1 Ci] of C-14, and 37 Gbq [1 Ci] of all other radionuclides combined. 

4  Record the date, radionuclide(s), estimated activity of each radionuclide, location where 

5 the material is discharged, and the name of the individual discharging the waste. 

6  Liquid waste should be discharged only via designated sinks, toilets, or other release 

7 points. 

8  Discharge liquid waste slowly to minimize splashing with water running, to be sure that 

9 the material moves out of the sink and into the sewer system. 

10  Survey the sink and surrounding work surfaces to confirm that no residual material or 

11 contamination remained in the sink or on work surfaces. 

12  Decontaminate all areas or surfaces if found to be contaminated. 

13  Maintain records of releases of licensed material to the sanitary sewer system. These 

14 records should include, for each release, the date, radionuclide(s), estimated activity of 

15 each radionuclide, location where the material is discharged, and the initials of the 

16 individual discharging the waste. For the licensed facility as a whole, records should be 

17 maintained of the quantity and concentration of radionuclides that are released into the 

18 sewer system that demonstrate compliance with the regulatory limits for total quantity 

19 released and concentrations released by the licensed facility.
1 APPENDIX X 

2 RECORDKEEPING REQUIREMENTS 

X–1 

1 Recordkeeping Requirements 

Table X–1. Typical Records and Retention Times 

Record Survey 

Requirement

Recordkeeping 

Requirement Retention Period

Results of surveys and calibrations 20.1501; 

20.1906(b) 20.2103(a) 3 years 

Results of surveys to determine dose 

from external sources 20.2103(b)(1) duration of license

Results of measurements and 

calculations used to determine 

individual intakes 

 20.2103(b)(2) duration of license

Results of air samplings, surveys, 

and bioassays 

20.1703(c)(1); 

20.1703(c)(2) 20.2103(b)(3) duration of license

Results of measurements and 

calculations used to evaluate the 

release of radioactive effluents to 

the environment 

 20.2103(b)(4) duration of license

Determination of prior occupational dose 20.2104 duration of license

Planned special exposure 20.1206 20.2105 duration of license

Individual monitoring results 20.1502 20.2106 duration of license

Dose to declared pregnant woman 20.1502 20.2106 duration of license

Dose to individual members of the public 20.1301 20.2107 duration of license

Waste disposal 

20.2002; 

20.2003; 

20.2004; 

20.2005 

20.2108 duration of license

Records of information important to the 

decommissioning of a facility 30.35(g) duration of license

Records of receipt of byproduct material 30.51(a)(1) 

duration of 

possession and 

3 years after 

transfer 

Records of transfer of byproduct material 30.51(a)(2) 3 years after 

transfer 

Records of disposal of byproduct material 30.51(a)(3) duration of license

Authority and responsibilities of radiation 

protection program 35.24(a) 35.2024 5 years 

Radiation protection program changes 35.26(a) 35.2026 5 years 

Written directives 35.40 35.2040 3 years 

Procedures for administrations requiring 

a written directive 35.41(a) 35.2041 duration of license

Calibrations of instruments used to 

measure activity of unsealed byproduct 

material 

35.60 35.2060 3 years 

Radiation survey instrument calibrations 35.61 35.2061 3 years 

Dosages of unsealed byproduct material 

for medical use 35.63 35.2063 3 years 
X–2 

Table X–1. Typical Records and Retention Times (Continued)

Record Survey 

Requirement

Recordkeeping 

Requirement Retention Period

Leak tests and inventory of sealed 

sources and brachytherapy sources 35.67(b) 35.2067 3 years 

Surveys for ambient radiation 

exposure rate 35.70 35.2070 3 years 

Release of individuals containing 

unsealed byproduct material or implants 

containing byproduct material 

35.75 35.2075 3 years after date 

of release 

Mobile medical services 35.80(a)(1) 35.2080(a) 

3 years after last 

provision of 

service 

Surveys of client facilities 35.80(a)(4) 35.2080(b) 3 years 

Decay-in-storage 35.92 35.2092 3 years 

Molybdenum-99 or strontium-82 or 

strontium-85 concentrations 35.204(b) 35.2204 3 years 

Safety instruction 

35.310; 

35.410; 

35.610 

35.2310 3 years 

Surveys after source implant 

and removal 

35.404; 

35.604 35.2404 3 years 

Brachytherapy source accountability 35.406 35.2406 3 years 

Calibration measurements of 

brachytherapy sources 35.432 35.2432 3 years after last use of source 

Decay of strontium-90 sources for 

ophthalmic treatments 35.433 35.2433 life of source 

Installation, maintenance, adjustment, 

and repair of remote afterloader units, 

teletherapy units, and gamma 

stereotactic radiosurgery units 

35.604 35.2605 3 years 

Emergency procedures for therapy 

devices containing sealed sources 

35.610(a)(4); 

35.610(d)(2) 35.2610 

duration of 

possession of 

specified 

equipment 

Dosimetry equipment used with remote 

afterloader units, teletherapy units, and 

gamma stereotactic radiosurgery units 

35.630 35.2630 duration of license

Teletherapy, remote afterloader, and 

gamma stereotactic radiosurgery 

full calibrations 

35.632; 

35.633; 

35.635 

35.2632 3 years 

Periodic spot-checks of teletherapy units 35.642 35.2642 3 years 

Periodic spot-checks of remote 

afterloader units 35.643 35.6243 3 years 

Periodic spot-checks of gamma 

stereotactic radiosurgery units 35.645 35.6245 3 years 

Additional technical requirements for 

mobile remote afterloader units 35.647 35.6247 3 years 

Surveys of therapeutic treatment units 35.652 35.2652 duration of use of 

unit 
X–3 

Table X–1. Typical Records and Retention Times (Continued)

Record Survey 

Requirement

Recordkeeping 

Requirement Retention Period

5-year inspection for teletherapy and 

gamma stereotactic radiosurgery units 35.655 35.2655 duration of use of unit 

Documentation regarding the 

trustworthiness and reliability of 

individual employees 

 37.23(h)(1) 

3 years from the 

date the individual 

no longer requires 

unescorted access 

Current access authorization 

program procedures 37.23(h)(2) 

3 years after the 

procedure is 

superseded or no 

longer needed 

List of persons approved for unescorted 

access authorization 37.23(h)(3) 

3 years after the 

list is superseded 

or replaced 

Documentation supporting relief from 

fingerprinting, identification, and criminal 

history records checks and other 

elements of background investigations 

 37.31 

3 years from the 

date the individual 

no longer requires 

unescorted access

Copy of current security plan 37.43(a)(4) 

3 years after the 

plan is superseded 

or no longer 

required 

Copy of current implementing procedure 37.43(b)(3) 

3 years after the 

procedure is 

superseded or no 

longer required 

Documentation of initial and refresher 

training 37.43(c)(4) 3 years from the date of the training

Documentation for preplanning and 

coordination of shipment 37.75(e) 3 years 

Record retention when a retention period 

is not otherwise specified 37.103 duration of license

1 APPENDIX Y 

2 REPORTING REQUIREMENTS 

Y–1 

1 Reporting Requirements 

2 Note: The following list of notification and reporting requirements is provided to inform licensees 

3 about typical notification and reporting requirements that apply to their licensed activities. 

4 Licensees should note that the list is incomplete in that not all potentially applicable 

5 requirements have been included. Also, notification and reporting requirements change; 

6 therefore, licensees should consult the regulations for definitive information about current 

7 requirements. 

Table Y–1. Typical NRC Notifications and/or Reports 

Event Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Reports to individual workers None annually 10 CFR 19.13(b) 

Reports to former individual 

workers 

None upon request 10 CFR 19.13(c) 

Notification of special 

circumstances to individuals 

None 30 days 10 CFR 19.13(d) 

Reports to worker terminating 

employment 

None upon request 10 CFR 19.13(e) 

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 

[U.S. Nuclear 

Regulatory 

Commission (NRC) 

and final delivery 

carrier must be 

notified] 

none 20.1906(d) 

Theft or loss of material Immediate 30 days 10 CFR 

20.2201(a)(1)(i) 

10 CFR 20.2201(b)(1) 

Whole body dose greater than 0.25 

Sieverts (Sv) [25 rems] 

Immediate 30 days 10 CFR 

20.2202(a)(1)(i), 

10 CFR 20.2203 (a) 

Extremity dose greater than 2.5 Sv 

[250 rems] 

Immediate 30 days 10 CFR 

20.2202(a)(1)(iii), 

10 CFR 20.2203 (a) 

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) 

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) 

Doses in excess of specified 

criteria 

None 30 days 10 CFR 20.2203(a)(2) 

Levels of radiation or 

concentrations of radioactive 

material in excess of specified 

criteria 

None 30 days 10 CFR 20.2203(a)(3) 

10 CFR 20.2203 (a) 

Planned special exposures None 30 days 10 CFR 20.2204 

Report to individuals of exceeding 

dose limits 

None 30 days 10 CFR 20.2205 

Report of individual monitoring None annually 10 CFR 20.2206 
Y–2 

Table Y–1. Typical NRC Notifications and/or Reports (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Defect in equipment that could 

create a substantial safety hazard 

2 days 30 days 10 CFR 21.21(d)(3)(i) 

10 CFR 21.21(d)(3)(ii) 

Event that prevents immediate 

protective actions necessary to 

avoid exposure to radioactive 

materials that could exceed 

regulatory limits 

Immediate (not more 

than 4 hours after 

discovery) 

30 days 10 CFR 30.50(a) 

10 CFR 30.50(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 30.50(b)(2) 

10 CFR 30.50(c)(2) 

Unplanned fire or explosion that 

affects the integrity of any licensed 

material or device, container, or 

equipment with licensed material 

24 hours 30 days 10 CFR 30.50(b)(4) 

Generally licensed devices None 30 days 10 CFR 31.5(c)(14) 

Licensee permits individual to work 

as authorized users (AU), 

authorized nuclear pharmacists 

(ANP), or authorized medical 

physicist (AMP) 

None 30 days 10 CFR 35.14(a) 

AU, ANP, or AMP discontinues 

performance of duties under 

license or has a name change 

None 30 days 10 CFR 35.14(b)(1) 

Temporary Radiation Safety Officer None 30 days 10 CFR 35.14(b)(2) 

Licensee’s mailing address 

changes 

None 30 days 10 CFR 35.14(b)(3) 

Licensee’s name changes without 

constituting a transfer of control 

None 30 days 10 CFR 35.14(b)(4) 

Licensee adds or changes areas of 

10 CFR 35.100 or 35.200 use of 

byproduct material identified in 

application or license 

None 30 days 10 CFR 35.14(b)(5) 

Medical event 1 day 15 days 10 CFR 35.3045(c) 

10 CFR 35.3045(d) 

Dose to an embryo/fetus that is 

greater than 50 millisieverts (mSv) 

[5 rem] dose equivalent 

1 day 15 days 10 CFR 35.3047(c) 

Dose to a nursing child that is 

greater than 50 mSv [5 rem] or 

resulted in unintended permanent 

functional damage 

1 day 15 days 10 CFR 35.3047(d) 

Leaking source None 5 days 10 CFR 35.3067 
Y–3 

Table Y–1. Typical NRC Notifications and/or Reports (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

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) 

Coordination with local law 

enforcement agency (LLEA) has 

failed, either because the LLEA has 

not responded or because the 

LLEA does not plan to participate 

3 business days Submittal of a 

written report 

concerning 

failures of 

coordination 

with LLEA as 

described in 10 

CFR 37.45(b) is 

not required; 

however, 

licensees must 

document their 

efforts to 

coordinate with 

the LLEA and 

keep this 

documentation 

for 3 years 

10 CFR 37.45(b) 

Determination that an 

unauthorized entry resulted in an 

actual or attempted theft, sabotage, 

or diversion of Category 1 or 

Category 2 quantity of radioactive 

material 

As soon as possible 

(but not at the 

expense of causing 

delay or interfering 

with the LLEA 

response), but no 

later than 4 hours 

after discovery 

30 days 10 CFR 37.57(a)&(c) 

Assessment of any suspicious 

activity related to possible theft, 

sabotage, or diversion of Category 

1 or Category 2 quantities of 

radioactive material 

As soon as possible, 

but no later than 4 

hours after notifying 

the LLEA 

none 10 CFR 37.57(b) 

Determination that a shipment 

containing a Category 1 quantity of 

material is lost or missing in 

transport 

Within 1 hour of the 

determination. Also, 

notify LLEA within 1 

hour of determination

30 days and 

periodic updates 

[10 CFR 

37.79(c)] 

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) 
Y–4 

Table Y–1. Typical NRC Notifications and/or Reports (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Discovery along the route of any 

actual or attempted theft or 

diversion, or suspicious activity, 

related to a Category 1 quantity of 

material in transport 

Upon discovery, as 

soon as possible. 

Also notify LLEA as 

soon as possible 

upon discovery 

30 days (except 

no report for 

suspicious 

activity) 

10 CFR 37.81(c)&(g) 

Discovery of any actual or 

attempted theft or diversion, or 

suspicious activity, related to a 

Category 2 quantity of material in 

transport 

As soon as possible 30 days (except 

no report for 

suspicious 

activity) 

10 CFR 37.81(d)&(g) 

Upon recovery of any lost or 

missing Category 1 quantity of 

material 

As soon as possible. 

Also notify the LLEA 

as soon as possible 

To be included 

in the 30-day 

report of an 

event described 

in 10 CFR 

37.81(g), if 

recovered 

during that time 

10 CFR 37.81(e)&(h) 

Upon recovery of any lost or 

missing Category 2 quantity of 

material 

As soon as possible To be included 

in the 30-day 

report of an 

event described 

in 10 CFR 

37.81(g), if 

recovered 

during that time 

10 CFR 37.81(f)&(h) 

1 Note: Telephone notifications shall be made to the NRC Operations Center at (301) 816-5100, 

2 except as noted. 
1 APPENDIX Z 

2 SUMMARY OF DOT REQUIREMENTS FOR TRANSPORTATION OF TYPE A, 

3 TYPE B, OR LIMITED QUANTITIES OF LICENSED MATERIAL 

Z–1 

1 Summary of DOT Requirements for Transportation of Type A, Type B, or 

2 Limited Quantities of Licensed Material 

3 Note: The reference charts included at the end of this Appendix are for reference only and are 

4 not a substitute for U.S. Department of Transportation (DOT) and U.S. Nuclear Regulatory 

5 Commission (NRC) transportation regulations. 

6 Licensed material must be transported in accordance with DOT regulations. Applicants and 

7 licensees should review the most recent regulations in Title 49 of the Code of Federal 

8 Regulations (49 CFR). The following are the major areas in DOT regulations most relevant for 

9 medical use licensees transporting licensed material: 

10  Table of Hazardous Materials and Special Provisions—Subpart B 

11 — 49 CFR 172.101—Purpose and Use of Hazardous Materials Table 

12 [proper shipping name, hazard class, identification number] 

13 — Table 2, Appendix A to 49 CFR 172.101—List of Hazardous Substances and 

14 Reportable Quantities [for radionuclides] 

15  Shipping Papers—Subpart C 

16 — 49 CFR 172.201—Preparation and retention of shipping papers 

17 — 49 CFR 172.202—Description of hazardous material on shipping papers 

18 — 49 CFR 172.203—Additional description requirements 

19 — 49 CFR 172.204—Shipper’s certification [if applicable] 

20  Markings—Subpart D 

21 — 49 CFR 172.301—General marking requirements for non-bulk packagings 

22 — 49 CFR 172.304—Marking requirements 

23 — 49 CFR 172.310—Class 7 (radioactive) materials 

24 — 49 CFR 172.324—Hazardous substances in non-bulk packagings [designation of 

25 “reportable quantities” with the letters “RQ”] 

26  Labeling—Subpart E 

27 — 49 CFR 172.400—General labeling requirements 

28 — 49 CFR 172.400(a)—Exceptions from labeling 

29 — 49 CFR 172.403—Class 7 (radioactive) material 

30 — 49 CFR 172.406—Placement of labels 

31 — 49 CFR 172.436, 172.438, 172.440, 172.450—Labels [White-1, Yellow-2, 

32 Yellow-3, Empty] 

33  Placarding—Subpart F 

34 — 49 CFR 172.504—General placarding requirements 

35 — 49 CFR 172.516—Visibility and display of placards 

36 — 49 CFR 172.556—RADIOACTIVE placard 
Z–2 

1  Emergency Response Information—Subpart G 

2 — 49 CFR 172.600—Applicability and general requirements 

3 — 49 CFR 172.602—Emergency response information 

4 — 49 CFR 172.604—Emergency response telephone number 

5  Training—Subpart H 

6 — 49 CFR 172.702—Applicability and responsibility for training and testing 

7 — 49 CFR 172.704—Training requirements [types of training, frequency, 

8 recordkeeping] 

9  Safety and Security Plans – Subpart I 

10 — 49 CFR 172.800 – Purpose and applicability 

11 — 49 CFR 172.802 – Components of a security plan 

12  Shippers—General Requirements for Shipments and Packaging—49 CFR Part 173 

13 — Class 7 (Radioactive Materials) – Subpart I. 

14 – 49 CFR 173.25—Authorized packagings and overpacks 

15 – 49 CFR 173.403—Definitions 

16 – 49 CFR 173.410—General design requirements 

17 – 49 CFR 173.412—Additional design requirements for Type A packages 

18 – 49 CFR 173.413—Requirements for Type B packages 

19 – 49 CFR 173.415—Authorized Type A packages 

20 – 49 CFR 173.416—Authorized Type B packages [includes packaging 

21 certification requirements] 

22 – 49 CFR 173.421—Excepted packages for limited quantities of Class 7 

23 (radioactive) materials 

24 – 49 CFR 173.422—Additional requirements for excepted packages 

25 containing Class 7 (radioactive) materials 

26 – 49 CFR 173.425—Table of activity limits—excepted quantities and 

27 articles [limited quantity] 

28 – 49 CFR 173.431—Activity limits for Type A and Type B packages 

29 – 49 CFR 173.435—Table of A1 and A2 values for radionuclides [for 

30 determination of package type] 

31 – 49 CFR 173.441—Radiation level limitations and exclusive use provisions 

32 – 49 CFR 173.443—Contamination control 

33 – 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory 

34 Commission approved packages 

35 – 49 CFR 173.476—Approval of special form Class 7 (radioactive) 

36 materials [includes requirement for documentation of special form status] 

37  Carriage by Public Highway—49 CFR Part 177 

38 — General Information and Regulations-Subpart A 

39 — 49 CFR 177.817—Shipping papers [location of shipping papers during 

40 transport] 
Z–3 

1  Loading and Unloading – Subpart B 

2 — 49 CFR 177.842—Class 7 (radioactive) material [includes requirement for 

3 blocking and bracing during transport] 

4 Applicants should visit the DOT Web site for additional information on transportation 

5 requirements: http://www.dot.gov/. 
Z–4 
Z–5 
Z–6 

 
Z–7 
Z–8 
Z–9 
Z–10 
Z–11 

1 APPENDIX AA 

2 LIST OF REFERENCES AND RESOURCES 

AA–1 

1 List of References and Resources

2 Some sections of the guidance include references to other documents or resources that may be 

3 useful to the applicant or licensee. This Appendix provides a complete list of documents used 

4 to prepare or referenced in the guidance. If reference or resource documents include 

5 information conflicting with current regulations, the regulations in Title 10 of the Code of Federal 

6 Regulations (CFR) apply. For example, some references or resources may include alternate 

7 limits for occupational and public dose; however, licensees should note that the limits in 

8 10 CFR Part 20 are applicable. Many of these documents may be accessed online at the 

9 U.S. Nuclear Regulatory Commission Library or using the links provided for each section below. 

10 See the Notice of Availability on the inside front cover of this report for more information. 

11 Title 10 of the Code of Federal Regulations

12 1. Part 2 – Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders 

13 2. Part 19 – Notices, Instructions, and Reports to Workers; Inspections and Investigations 

14 3. Part 20 – Standards for Protection Against Radiation 

15 4. Part 21 – Reporting of Defects and Noncompliance 

16 5. Part 30 – Rules of General Applicability to Domestic Licensing of Byproduct Material 

17 6. Part 31 – General Domestic Licenses for Byproduct Material 

18 7. Part 32 – Specific Domestic Licenses to Manufacture or Transfer Certain Items 

19 Containing Byproduct Material 

20 8. Part 33 – Specific Domestic Licenses of Broad Scope for Byproduct Material 

21 9. Part 35 – Medical Use of Byproduct Material 

22 10. Part 40 – Domestic Licensing of Source Material 

23 11. Part 70 – Domestic Licensing of Special Nuclear Material 

24 12. Part 71 – Packaging and Transportation of Radioactive Material 

25 13. Part 150 – Exemptions and Continued Regulatory Authority in Agreement States and in 

26 Offshore Waters Under Section 274 

27 14. Part 170 – Fees for Facilities, Materials, Import and Export Licenses, and Other 

28 Regulatory Services Under the Atomic Energy Act of 1954, as Amended 

29 15. Part 171 – Annual Fees for Reactor Licenses and Fuel Cycle Licenses and Materials 

30 Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality 

31 Assurance Program Approvals and Government Agencies Licensed by the NRC 

32 16. Title 49 of the Code of Federal Regulations
AA–2 

1 17. Part 172 – Hazardous Materials Table, Special Provisions, Hazardous Materials 

2 Communications, Emergency Response Information, and Training Requirements 

3 18. Part 173 – Shippers – General Requirements for Shipments and Packaging 

4 19. Part 177 – Carriage by Public Highway 

5 20. Part 178 – Specifications for Packaging 

6 NRC Regulatory Guides

7 21. RG 1.86, “Termination of Operating Licenses for Nuclear Reactors,” June 1974. 

8 22. RG 7.10, “Establishing Quality Assurance Programs for Packaging Used in the 

9 Transport of Radioactive Material,” Revision 2, March 2005. 

10 23. RG 8.7, “Instructions for Recording and Reporting Occupational Radiation Exposure 

11 Data,” Revision 2, November 2005. 

12 24. RG 8.9, “Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay 

13 Program,” Revision 1, July 1993. 

14 25. RG 8.10, “Operating Philosophy for Maintaining Occupational Radiation Exposures As 

15 Low As Is Reasonably Achievable,” Revision 1-R, September 1975. 

16 26. RG 8.13, “Instruction Concerning Prenatal Radiation Exposure,” Revision 3, June 1999. 

17 27. RG 8.18, “Information Relevant to Ensuring that Occupational Radiation Exposures at 

18 Medical Institutions Will Be As Low As Reasonably Achievable,” Revision 2, April 2011. 

19 28. RG 8.25, “Air Sampling in the Workplace,” Revision 1, June 1992. 

20 29. RG 8.29, “Instruction Concerning Risks from Occupational Radiation Exposure,” 

21 Revision 1, February 1996. 

22 30. RG 8.34, “Monitoring Criteria and Methods to Calculate Occupational Radiation Doses,” 

23 July 1992. 

24 31. RG 8.36, “Radiation Dose to the Embryo/Fetus,” July 1992. 

25 32. RG 8.39, “Release of Patients Administered Radioactive Materials,” April 1997. 

26 33. RG 8.4, “Methods for Measuring Effective Dose Equivalent from External Exposure,” 

27 June 18, 2015. 

28 NRC Information Notices

29 34. IN 94-09, “Release of Patients with Residual Radioactivity,” February 3, 1994. 

30 35. IN 99-02, “Guidance to Users on the Implementation of a New Single-Source 

31 Dose-Calculation Formalism and Revised Air-Kerma Strength Standard for Iodine-125 

32 Sealed Sources,” January 21, 1999. 
AA–3 

1 36. IN 99-11, “Incidents Involving the Use of Radioactive Iodine-131,” April 16, 1999. 

2 37. IN 99-33, “Management of Wastes Contaminated with Radioactive Materials,” 

3 December 21, 1999. 

4 38. IN 2000-05, “Recent Medical Misadministrations Resulting from Inattention to Detail,” 

5 March 6, 2000. 

6 39. IN 2000-19, “Implementation of Human Research Protocols Involving U.S. Nuclear 

7 Regulatory Commission Regulated Materials,” December 5, 2000. 

8 40. IN 2000-22, “Medical Misadministrations Caused by Human Errors Involving Gamma 

9 Stereotactic Radiosurgery (Gamma Knife),” December 18, 2000. 

10 41. IN 2002-19, “Medical Misadministrations Caused by Failure to Properly Perform Tests 

11 on Dose Calibrators for Beta- and Low-Energy Photon-Emitting Radionuclides,” 

12 June 14, 2002. 

13 42. IN 2003-21, “High-Dose-Rate-Remote-Afterloader Equipment Failure,” 

14 November 24, 2003. 

15 43. IN 2003-22, “Heightened Awareness for Patients Containing Detectable Amounts of 

16 Radiation from Medical Administrations,” December 9, 2003. 

17 44. IN 2003-22 Supplement 1, “Heightened Awareness for Patients Containing Detectable 

18 Amounts of Radiation from Medical Administrations,” July 29, 2009. 

19 45. IN 2005-17, “Manual Brachytherapy Source Jamming,” June 23, 2005. 

20 46. IN 2006-11, “Applicability of Patient Intervention in Determining Medical Events for 

21 Gamma Stereotactic Radiosurgery and Other Therapy Procedures,” June 12, 2006. 

22 47. IN 2007-03, “Reportable Medical Events Involving Patients Receiving Dosages of 

23 Sodium Iodide Iodine-131 Less Than the Prescribed Dosage Because of Capsules 

24 Remaining in Vials After Administration,” February 2, 2007. 

25 48. IN 2007-10, “Yttrium-90 Theraspheres® and Sirspheres® Impurities,” March 13, 2007. 

26 49. IN 2007-25 Suggestion from the Advisory Committee on the Medical Use of Isotopes for 

27 Consideration to Improve Compliance With Sodium Iodide I-131 Written Directive 

28 Requirements in 10 CFR 35.40 and Supervision Requirements in 10 CFR 35.27,” 

29 July 19, 2007. 

30 50. IN-2007-35, “Varian Medical Systems Varisource HDR Events: Iridium-192 Source 

31 Pulled From Shielded Position,” October 17, 2007. 

32 51. IN-2007-38, “Ensuring Complete and Accurate Information in the Documentation of 

33 Training and Experience for Individuals Seeking Approval as Medical Authorized Users,” 

34 December 14, 2007. 

35 52. IN 2008-22, “Molybdenum-90 Breakthrough in Molybdenum-99/Technetium-99M 

36 Generators,” January 12, 2009. 
AA–4 

1 53. IN 2009-15, “Varian Medical Systems Varisource High Dose-Rate Remote Afterloader 

2 Events: Source Retraction Problems,” August 28, 2009. 

3 54. IN 2009-17, “Reportable Medical Events Involving Treatment Delivery Errors Caused By 

4 Confusion of Units for the Specification of Brachytherapy Sources,” August 28, 2009. 

5 55. IN 2012-08, “High Dose-Rate Remote Afterloader (HDR) Physical Presence 

6 Requirements,” April 10, 2012. 

7 56. IN 2013-16, “Importance of Verification of Treatment Parameters for High Dose-Rate 

8 Remote Afterloader Administrations,” August 12, 2013. 

9 57. IN 2013-22, “Recent Licensing Submittals Containing Personally Identifiable 

10 Information,” November 15, 2013. 

11 NRC Regulatory Issue Summaries

12 58. RIS 2005-23, “Clarification of the Physical Presence Requirement During Gamma 

13 Stereotactic Radiosurgery Treatments,” October 7, 2005. 

14 59. RIS 2005-24, “Control of Radiation Dose to Visitors of Hospital Patients,” 

15 November 23, 2005. 

16 60. RIS 2005-31, “Control of Security-Related Sensitive Unclassified Non-Safeguards 

17 Information Handled by Individuals, Firms, and Entities Subject to NRC Regulation of the 

18 Use of Source, Byproduct, and Special Nuclear Material,” December 22, 2005. 

19 61. RIS 2006-18, “Requesting Exemption from the Public Dose Limits for Certain Caregivers 

20 of Hospital Patients,” August 31, 2006. 

21 62. RIS 2007-04, “Personally Identifiable Information Submitted to the U.S. Nuclear 

22 Regulatory Commission,” March 9, 2007. 

23 63. RIS 2008-07, “Dose Limits for Patient Release Under 10 CFR 35.75,” March 27, 2008. 

24 64. RIS 2008-11, “Precautions to Protect Children Who May Come In Contact with Patients 

25 Released After Therapeutic Administrations of Iodine-131,” May 12, 2008. 

26 65. RIS 2008-31, “Licensing Requirements for Sentinel Lymph Node Biopsy,” 

27 December 1, 2008. 

28 66. RIS 2011-01, “NRC Policy on Release of Iodine-131 Therapy Patients Under 

29 10 CFR 35.75 to Locations Other Than Private Residences,” January 25, 2011. 

30 67. RIS 2013-12, “Notice of Issuance of Enforcement Guidance Memorandum – Interim 

31 Guidance for Dispositioning Violations Involving 10 CFR 35.60 and 10 CFR 35.63 for the 

32 Calibration of Instrumentation to Measure the Activity of Rubidium-82 and the 

33 Determination of Rubidium-82 Patient Dosages,” August 23, 2013. 

34 68. RIS 2014-08, “Regulatory Requirements for Transfer of Control (Change of Ownership) 

35 of Specific Materials Licenses,” May 27, 2014. 
AA–5 

1 NRC NUREGs

2 69. NUREG–1400, “Air Sampling in the Workplace,” September, 1993. 

3 70. NUREG–1492, “Regulatory Analysis on Criteria for the Release of Patients Administered 

4 Radioactive Material,” February 1997. 

5 71. NUREG–1556, Volume 9, Revision 2, “Consolidated Guidance About Materials 

6 Licenses: Program-Specific Guidance About Medical Use Licenses,” January 2008. 

7 72. NUREG–1556, Volume 11, “Consolidated Guidance About Materials Licenses: 

8 Program-Specific Guidance About Licenses of Broad Scope,” April 1999. 

9 73. NUREG–1556, Volume 15, “Consolidated Guidance About Materials Licenses: 

10 Program-Specific Guidance About Changes of Control and About Bankruptcy Involving 

11 Byproduct, Source, or Special Nuclear Material Licenses,” November 2000. 

12 74. NUREG–1556, Volume 18, “Consolidated Guidance About Materials Licenses: 

13 Program- Specific Guidance About Service Provider Licenses,” November 2000. 

14 75. NUREG–1556, Volume 21, “Consolidated Guidance About Materials Licenses: 

15 Program- Specific Guidance About Possession Licenses for Production of Radioactive 

16 Sources Using an Accelerator,” October 2007. 

17 76. NUREG–1736, “Consolidated Guidance: 10 CFR Part 20 – Standards for Protection 

18 Against Radiation,” October 2001. 

19 77. NUREG–1757, Volume 2, Revision 1, “Consolidated Decommissioning Guidance: 

20 Characterization, Survey, and Determination of Radiological Criteria,” September 2006. 

21 78. NUREG–1757, Volume 3, Revision 1, “Consolidated Decommissioning Guidance: 

22 Financial Assurance, Recordkeeping, and Timeliness,” February 2012. 

23 79. NUREG–2155, Revision 1, “Implementation Guidance for 10 CFR Part 37, “Physical 

24 Protection of Category 1 and Category 2 Quantities of Radioactive Material” January 

25 2015. 

26 80. NUREG–2166, “Physical Security Best Practices for the Protection of Risk-Significant 

27 Radioactive Material,” May 2014. 

28 81. NUREG/CR–4444, “Radiation Safety Issues Related to Radiolabeled Antibodies,” 1991. 

29 82. NUREG/CR–4884, “Interpretation of Bioassay Measurement,” July 1987. 

30 National Council on Radiation Protection and Measurements Reports

31 83. NCRP Report No. 30, “Safe Handling of Radioactive Materials,” March 1964. 

32 84. NCRP Report No. 37, “Precautions in the Management of Patients Who Have Received 

33 Therapeutic Amounts of Radionuclides,” 1970. 
AA–6 

1 85. NCRP Report No. 40, “Protection Against Radiation from Brachytherapy Sources,” 1972. 

2 86. NCRP Report No. 49, “Structural Shielding Design and Evaluation for Medical Use of 

3 X-Rays and Gamma Rays of Energies up to 10 MeV,” 1976. 

4 87. NCRP Report No. 57, “Instrumentation and Monitoring Methods for Radiation 

5 Protection,” 1978. 

6 88. NCRP Report No. 58, “A Handbook of Radioactivity Measurement Procedures, Second 

7 Edition,” 1985. 

8 89. NCRP Report No. 65, “Management of Persons Accidentally Contaminated with 

9 Radionuclides,” 1980 

10 90. NCRP Report No. 69, “Dosimetry of X-Ray and Gamma-Ray Beams for Radiation 

11 Therapy in the Energy Range 10 keV to 50 MeV,” 1981. 

12 91. NCRP Report No. 87, “Use of Bioassay Procedures for Assessment of Internal 

13 Radionuclide Deposition,” February 1987. 

14 92. NCRP Report No. 88, “Radiation Alarms and Access Control Systems,” 1986. 

15 93. NCRP Report No. 102, “Medical X-Ray, Electron Beam and Gamma-Ray Protection for 

16 Energies up to 50 MeV (Equipment Design, Performance and Use),” 1989. 

17 94. NCRP Report No. 105, “Radiation Protection for Medical and Allied Health Personnel,” 

18 1989. 

19 95. NCRP Report No. 107, “Implementation of the Principle of As Low As Reasonably 

20 Achievable (ALARA) for Medical and Dental Personnel,” 1990. 

21 96. NCRP Report No. 111, “Developing Radiation Emergency Plans for Academic, Medical, 

22 and Industrial Facilities,” 1991. 

23 97. NCRP Report No. 112, “Calibration of Survey Instruments Used in Radiation Protection 

24 for the Assessment of Ionizing Radiation Fields and Radioactive Surface 

25 Contamination,” 1991. 

26 98. NCRP Report No. 122, “Use of Personal Monitors to Estimate Effective Dose Equivalent 

27 and Effective Dose to Workers For External Exposure to Low-LET Radiation,” 1995. 

28 99. NCRP Report No. 124, “Sources and Magnitude of Occupational and Public Exposures 

29 from Nuclear Medicine,” March 1996. 

30 100. NCRP Report No. 127, “Operational Radiation Safety Program,” June 1998. 

31 101. NCRP Report No. 128, “Radionuclide Exposure of the Embryo/Fetus,” September 1998. 

32 102. NCRP Report No. 134, “Operational Radiation Safety Training,” October 2000. 

33 103. NCRP Report No. 151, “Structural Shielding Design and Evaluation for Megavoltage 

34 X- and Gamma-Ray Radiotherapy Facilities,” 2005. 
AA–7 

1 104. NCRP Report No. 155, “Management of Radionuclide Therapy Patients,” December 

2 2006. 

3 105. NCRP Report No. 162, “Self Assessment of Radiation Safety Programs,” 2009. 

4 106. NCRP Commentary No. 11, “Dose Limits for Individuals Who Receive Exposure from 

5 Radionuclide Therapy Patients,” February 1995. 

6 International Commission on Radiological Protection Publications

7 107. ICRP Report No. 26, “Recommendations of the International Commission on 

8 Radiological Protection,” 1977. 

9 108. ICRP Report No. 30, “Limits for Intakes of Radionuclides by Workers,” 1978. 

10 109. ICRP Publication No. 53, “Radiation Dose to Patients from Radiopharmaceuticals,” 

11 1987. 

12 110. ICRP Publication No. 54, “Individual Monitoring for Intake of Radionuclides by Workers: 

13 Design and Interpretation,” 1987. 

14 111. ICRP Publication No. 60, “1990 Recommendations of the International Commission on 

15 Radiological Protection,” 1991. 

16 112. ICRP Report No. 75, “General Principles for the Radiation Protection of Workers,” 1997. 

17 113. ICRP Publication No. 78, “Individual Monitoring for Internal Exposure of Workers,” 1997. 

18 114. ICRP Report No. 80, “Radiation Dose to Patients from Radiopharmaceuticals 

19 (Addendum to ICRP Publication 53),” 1998. 

20 115. ICRP Report No. 106, “Radiation Dose to Patients from Radiopharmaceuticals 

21 (Addendum 3 to ICRP Publication 53),” 2008. 

22 American National Standards Institute Publications

23 116. ANSI N13.4-1971 (R1983) – Specification of Portable X- or Gamma-Radiation 

24 Survey Instruments. 

25 117. ANSI N13.5-1972 (R1989) – Performance and Specifications for Direct Reading and 

26 Indirect Reading Pocket Dosimeters for X- and Gamma-Radiation. 

27 118. ANSI N13.54-2008, “Fetal Radiation Dose Calculations.” 

28 119. ANSI N13.6-1966 (R1999) – Practice for Occupational Radiation Exposure 

29 Records Systems. 

30 120. ANSI N42.12-1994 – Calibration and Usage of Thallium-Activated Sodium Iodide 

31 Detector Systems for Assay of Radionuclides. 

32 121. ANSI N42.13-2004 – Calibration and Usage of “Dose Calibrator” Ionization Chambers 

33 for the Assay of Radionuclides. 
AA–8 

1 122. ANSI N42.15-1997 – Check Sources for and Verification of Liquid-Scintillation 

2 Counting Systems. 

3 123. ANSI N43.6-1997, “Sealed Radioactive Sources – Classification.” 

4 124. ANSI N322-1997 – Inspection, Test, Construction, and Performance Requirements for 

5 Direct Reading Electrostatic/Electroscope Type Dosimeters. 

6 125. ANSI N323AB-2013 – American National Standard for Radiation Protection 

7 Instrumentation Test and Calibration, Portable Survey Instruments. 

8 126. ANSI N449.1-1978 (R1984) – Procedures for Periodic Inspection of Cobalt-60 and 

9 Cesium-137 Teletherapy Equipment. 

10 American Association of Physicists in Medicine Reports

11 127. AAPM Task Group No. 21, “A Protocol for the Determination of Absorbed Dose from 

12 High-Energy Photon and Electron Beams,” 1984. 

13 128. AAPM Report No. 41, “Remote Afterloading Technology (Remote Afterloading 

14 Technology Task Group No. 41),” 1993. 

15 129. AAPM Report No. 46, “Comprehensive QA for Radiation Oncology, (Radiation Therapy 

16 Committee Task Group No. 40),” 1994. 

17 130. AAPM Report No. 54, “Stereotactic Radiosurgery, (Radiation Therapy Committee Task 

18 Group No. 42),” 1995. 

19 131. AAPM Report No. 59, “Code of Practice for Brachytherapy Physics, (Radiation Therapy 

20 Committee Task Group No. 56),” 1997. 

21 132. AAPM Report No. 61, “High Dose-Rate Brachytherapy Treatment Delivery, (Radiation 

22 Therapy Committee Task Group No. 59),” 1998. 

23 133. AAPM Report No. 67, “Protocol for Clinical Reference Dosimetry of High-Energy Photon 

24 and Electron Beams, Medical Physics 26(9), pp. 1847-1870, (Radiation Therapy 

25 Committee Task Group No. 51),” 1999. 

26 134. AAPM Report No. 68, “Permanent Prostate Seed Implant Brachytherapy, (AAPM Task 

27 Group No. 64),” 1999. 

28 135. AAPM Report No. 84, “Update of AAPM Task Group No. 43 Report: A Revised AAPM 

29 Protocol for Brachytherapy Dose Calculations,” 2004. 

30 136. Erratum: “Supplement to the 2004 update of the AAPM Task Group No.43 Report,” 

31 2004.

32 137. AAPM Report No. 84S, “Supplement to the 2004 Update of the AAPM Task Group 

33 No. 43 Report,” 2007. 

34 138. AAPM Task Group 108, “PET and PET/CT Shielding Requirements,” 2005. 
AA–9 

1 Other Technical Publications 

2 139. A. Brodsky, “Resuspension Factors and Probabilities of Intake of Material in Process (or 

3 ‘Is 10-6 a Magic Number in Health Physics?’),” Health Physics, Volume 39, Number 6, 

4 1980. 

5 140. A.P. Jacobson, P. A. Plato, and D. Toeroek, “Contamination of the Home Environment 

6 by Patients Treated with Iodine-131,” American Journal of Public Health, Volume 68, 

7 Number 3, 1978. 

8 141. A.S. Meigooni, S. Sabnis, R. Nath, “Dosimetry of Palladium-103 Brachytherapy Sources 

9 for Permanent Implants,” Endocurietherapy Hyperthermia Oncology, Volume 6, 

10 April 1990. 

11 142. American Thyroid Association, “Radiation Safety in the Treatment of Patients with 

12 Thyroid Diseases by Radioiodine 131I: Practice Recommendations of the American 

13 Thyroid Association,” Thyroid, Volume 21, Number 4, 335-346, 2011. 

14 143. International Atomic Energy Agency (IAEA), “Monitoring of Radioactive Contamination 

15 on Surfaces,” Technical Report Series No. 120, 1970. 

16 144. International Atomic Energy Agency (IAEA) Safety Reports Series No. 16, “Calibration of 

17 Radiation Protection Monitoring Instruments” (2000). 

18 145. International Commission on Radiation Units and Measurements, “Certification of 

19 Standardized Radioactive Sources,” Report No. 12, 1968. 

20 146. K.F. Eckerman, A. B. Wolbarst, and A. C. B. Richardson, “Federal Guidance Report No. 

21 11, Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion 

22 Factors for Inhalation, Submersion, and Ingestion,” Report No. EPA-520/1-88-020, 1988 

23 147. M. G. Stabin et al., “Radiation Dosimetry for the Adult Female and Fetus from Iodine-131 

24 Administration in Hyperthyroidism,” Journal of Nuclear Medicine, Volume 32, Number 5, 

25 May 1991. 

26 148. M. Stabin, “Internal Dosimetry in Pediatric Nuclear Medicine,” Pediatric Nuclear 

27 Medicine, 1995. 

28 149. R. C. T. Buchanan and J. M. Brindle, “Radioiodine Therapy to Out-patients – The 

29 Contamination Hazard,” British Journal of Radiology, Volume 43, 1970. 

150. R. Nath, A. S. Meigooni, and J. A. Meli, “Dosimetry on Transverse Axes of 125I and 192 30 Ir 

31 Interstitial Brachytherapy Sources,” Medical Physics, Volume 17, Number 6, 

32 November/December 1990. 

33 151. Scinta Inc., “The Health Physics and Radiological Health Handbook,” 1992. 

34 152. U.S. Department of Health, Education, and Welfare, “Radiological Health Handbook,” 

35 1970





NUREG-1556, Vol. 9

Revision 3, Draft

Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Medical Use Licenses