Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

Exempt Distribution Licenses

Draft Report for Comment

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 8, Rev. 1

Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

Exempt Distribution Licenses

Draft Report for Comment

Manuscript Completed: January 2017 

Date Published: January 2017

Prepared by: 

J. B. Carrico

G. Comfort

T. Herrera

C. Mattsen

R. Struckmeyer

S. Xu

Office of Nuclear Material Safety and Safeguards

 

NUREG-1556

Volume 8, Rev. 1
1 COMMENTS ON DRAFT REPORT 

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

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

4 specify the report number NUREG-1556, Volume 8, Revision 1, in your comments, and send 

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

6 availability of this report. 

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

8 Docket ID NRC-2016-0227 in the subject line of your comments. Comments submitted in 

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

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

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

12 filed under Docket ID NRC-2016-0227. Address questions about NRC dockets to 

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

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

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

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

17 For any questions about the material in this report, please contact: Katie Wagner, General 

18 Engineer at 301-415-6202 or by e-mail at Katie.Wagner@nrc.gov.

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

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

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

1 ABSTRACT 

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

3 assist applicants and licensees in preparing applications for exempt distribution licenses. In 

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

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

6 both the methods acceptable to NRC license reviewers in implementing the regulations and the 

7 techniques used by the reviewers in evaluating the application to determine if the proposed 

8 activities are acceptable for licensing purposes. 

9 Paperwork Reduction Act Statement 

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

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

12 by the Office of Management and Budget (OMB), approval numbers 3150-0014, 3150-0017, 

13 3150-0001, 3150-0010, 3150-0020, 3150-0036, and 3150-0120. 

14 Public Protection Notification 

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

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

17 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 

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

9 Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses,” is 

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

11 update to the previous information contained in NUREG-1556, Volume 8, issued 

12 September 1998. 
vi 

1 This report takes a risk-informed, performance-based approach to licensing the distribution of 

2 products and materials to be used under exemptions from licensing. A team composed of staff 

3 from NRC headquarters prepared this document, drawing on their collective experience in 

4 radiation safety in general and as specifically applied to exempt distribution licensing. 

5 NUREG-1556, Volume 8, Revision 1, is not a substitute for NRC regulations. The approaches 

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

7 different from those described in this report may be acceptable if they include a basis for the 

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

9 ________________________________________ 

10 Daniel S. Collins, Director 

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

12 Office of Nuclear Material Safety and Safeguards 
vii 

1 TABLE OF CONTENTS 

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

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

4 FIGURES ..................................................................................................................................... ix 

5 TABLES ....................................................................................................................................... ix 

6 ACKNOWLEDGMENTS .............................................................................................................. xi 

7 ABBREVIATIONS ..................................................................................................................... xiii 

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

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

10 3 MANAGEMENT RESPONSIBILITY .............................................................................. 3-1

11 3.1 Commitments and Responsibilities .................................................................... 3-1

12 3.2 Safety Culture ..................................................................................................... 3-2

13 4 APPLICABLE REGULATIONS ..................................................................................... 4-1

14 5 EXEMPT DISTRIBUTION .............................................................................................. 5-1

15 5.1 General ............................................................................................................... 5-1

16 5.2 Quality Assurance/Quality Control Programs ..................................................... 5-1

17 5.3 Licensing and Registration ................................................................................. 5-2

18 5.4 Possession Licenses .......................................................................................... 5-3

19 5.5 Product Transfer Reports ................................................................................... 5-4

20 5.6 Foreign Vendors ................................................................................................. 5-4

21 6 HOW TO FILE ................................................................................................................ 6-1

22 6.1 Application Preparation ...................................................................................... 6-1

23 6.2 Where To File ..................................................................................................... 6-1

24 6.3 Paper Applications ............................................................................................. 6-2

25 6.4 Electronic Applications ....................................................................................... 6-2

26 6.5 Identifying and Protecting Sensitive Information ................................................ 6-2

27 7 APPLICATION AND LICENSE FEES ........................................................................... 7-1

28 8 CONTENTS OF AN APPLICATION .............................................................................. 8-1

29 8.1 Item 1: License Action Type .............................................................................. 8-1

30 8.2 Item 2: Name and Mailing Address of Applicant................................................ 8-1

31 8.3 Item 3: Address(es) Where Licensed Material Will Be Used 

32 or Possessed ........................................................................................ 8-2

33 8.4 Item 4: Person To Be Contacted About This Application .................................. 8-3

34 8.5 Item 5: Radioactive Material .............................................................................. 8-4

35 8.6 Item 6: Purpose(s) For Which Licensed Material Will Be Used ......................... 8-4

36 8.7 Item 12: License Fees ....................................................................................... 8-4

37 8.8 Item 13: Certification ......................................................................................... 8-4

38 9 INFORMATION REQUIRED FOR SPECIFIC TYPES OF 

39 DISTRIBUTION LICENSES ........................................................................................... 9-1

40 9.1 10 CFR 32.11: Exempt Concentrations ............................................................. 9-1

41 9.2 10 CFR 32.14: Certain Items Containing Byproduct Material ............................ 9-4
viii 

1 9.3 10 CFR 32.18: Exempt Quantities ................................................................... 9-12

2 9.4 10 CFR 32.21: Radioactive Drug: Capsules Containing Carbon-14 

3 Urea for “In Vivo” Diagnostic Use for Humans ................................................. 9-17

4 9.5 10 CFR 32.22: Self-Luminous Products Containing Tritium, Krypton-85, 

5 or Promethium-147 ........................................................................................... 9-19

6 9.6 10 CFR 32.26: Gas and Aerosol Detectors Containing 

7 Byproduct Material ........................................................................................... 9-25

8 9.7 10 CFR 32.30: Certain Industrial Devices ....................................................... 9-30

9 9.8 10 CFR 40.52: Certain Items Containing Source Material .............................. 9-36

10 10 LICENSE AMENDMENTS AND RENEWALS ............................................................. 10-1

11 10.1 Timely Notification of Transfer of Control ......................................................... 10-1

12 10.2 Notification of Bankruptcy Proceedings ............................................................ 10-2

13 11 APPLICATIONS FOR EXEMPTIONS ......................................................................... 11-1

14 12 TERMINATION OF ACTIVITIES ................................................................................. 12-1

15 APPENDICES 

16 APPENDIX A UNITED STATES NUCLEAR REGULATORY COMMISSION 

17 FORM 313 ............................................................................................. A–1 

18 APPENDIX B RECORDS AND MATERIAL TRANSFER REPORTS ......................... B–1 

19 APPENDIX C INFORMATION NEEDED TO SUPPORT AN APPLICATION 

20 FOR A LICENSE UNDER 10 CFR 32.11 TO DISTRIBUTE 

21 IRRADIATED GEMSTONES TO PERSONS EXEMPT 

22 FROM LICENSING ................................................................................ C–1 

23 APPENDIX D ADDITIONAL GUIDANCE FOR SELF-LUMINOUS PRODUCTS ....... D–1 

24 APPENDIX E PRODUCTS COVERED UNDER CLASS EXEMPTIONS: 

25 SAFETY CRITERIA AND DOSE ASSESSMENTS .............................. E–1 

26 APPENDIX F QUESTIONS AND ANSWERS ABOUT SOURCE 

27 MATERIAL REGULATIONS ................................................................. F–1 

28 APPENDIX G SAFETY CULTURE POLICY STATEMENT ........................................ G–1 

29 APPENDIX H CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

30 INFORMATION FROM PUBLIC DISCLOSURE 

31 (UNDER 10 CFR 2.390) ........................................................................ H–1
ix 

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 Distribution. .................................................................................................. 8-3 

5 9-1 Example of Exempt Quantities: Labeling .................................................................... 9-15 

6 9-2 Example of Acceptable Radioactive Drug Labeling ..................................................... 9-18 

7 9-3 Example of Self-Luminous Products: Front and Rear Gun Sights. ............................. 9-20 

8 9-4 Smoke Detectors .......................................................................................................... 9-25 

9 TABLES 

10 Table Page 

11 2-1 Who Regulates the Possession and Use Activity? ........................................................ 2-2 

12 3-1 Traits of a Positive Safety Culture .................................................................................. 3-3 

13 9-1 10 CFR 30.15(a)(1) Timepieces or Hands or Dials ........................................................ 9-5 

14 9-2 10 CFR 30.15(a)(2)(i) Static Elimination Devices........................................................... 9-5 

15 9-3 10 CFR 30.15(a)(2)(ii) Ion-Generating Tubes Designed for Ionization of Air ................. 9-5 

16 9-4 10 CFR 30.15(a)(7) Ionization Chamber Smoke Detectors Designed to 

17 Protect Life and Property From Fires ............................................................................. 9-5 

18 9-5 10 CFR 30.15(a)(8) Electron Tubes ............................................................................... 9-6 

19 9-6 10 CFR 30.15(a)(9) Ionizing Radiation-Measuring Instruments for 

20 Purposes of Internal Calibration or Standardization ....................................................... 9-6 

21 9-7 10 CFR 40.13(c)(1)(i) Incandescent Gas Mantles........................................................ 9-36 

22 9-8 10 CFR 40.13(c)(1)(ii) Vacuum Tubes ......................................................................... 9-36 

23 9-9 10 CFR 40.13(c)(1)(iii) Welding Rods .......................................................................... 9-37 

24 9-10 10 CFR 40.13(c)(1)(iv) Electric Lamps for Illuminating Purposes ................................ 9-37 

25 9-11 10 CFR 40.13(c)(1)(v) Germicidal Lamps, Sunlamps, and Lamps for Outdoor 

26 or Industrial Lighting ..................................................................................................... 9-37 

27 9-12 10 CFR 40.13(c)(1)(vi) Rare Earth Metals and Compounds, 

28 Mixtures, and Products ................................................................................................ 9-37 

29 9-13 10 CFR 40.13(c)(1)(vii) Personnel Neutron Dosimeters .............................................. 9-37 

30 9-14 10 CFR 40.13(c)(2)(ii) Piezoelectric Ceramic ............................................................... 9-37 

31 9-15 10 CFR 40.13(c)(2)(iii) Glassware, Not Including Commercially 

32 Manufactured Glass Brick, Pane Glass, Ceramic Tile, or Other Glass or 

33 Ceramic Used in Construction ..................................................................................... 9-37 

34 9-16 10 CFR 40.13(c)(3) Photographic Film, Negatives, and Prints .................................... 9-37 

35 9-17 10 CFR 40.13(c)(4) Any Finished Product or Part Fabricated of, 

36 or Containing Tungsten or Magnesium Thorium Alloys ............................................... 9-38 

37 9-18 10 CFR 40.13(c)(5) Uranium Contained in Counterweights Installed 

38 in Aircraft, Rockets, Projectiles, and Missiles, or Stored or Handled in 

39 Connection With Installation or Removal of Such Counterweights .............................. 9-38 

40 9-19 10 CFR 40.13(c)(6) Natural or Depleted Uranium Metal Used as 

41 Shielding Constituting Part of Any Shipping Container ................................................ 9-39 
x 

1 9-20 10 CFR 40.13(c)(7) Thorium or Uranium Contained in or on Finished 

2 Optical Lenses and Mirrors .......................................................................................... 9-39 

3 9-21 10 CFR 40.13(c)(8) Finished Aircraft Engine Parts Containing 

4 Nickel Thoria Alloy ....................................................................................................... 9-39 

5 B–1 Quick Reference Table for Annual Transfer Reports .................................................... B–3 
xi 

1 ACKNOWLEDGMENTS 

2 The working group thanks the individuals listed below for assisting in the review and update of 

3 the report. All participants provided valuable insights, observations, and recommendations. 

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

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

6 that assisted in the development of this report. 

7 The working group also thanks Tomas Herrera for the pivotal role that he played in the 

8 development of this report. 

9 The Participants for this Revision 

10 Ashkeboussi, Nima 

11 Carrico, J. Bruce 

12 Comfort, Gary 

13 Mattsen, Catherine 

14 Struckmeyer, Richard 

15 Wagner, Katie 

16 Xu, Shirley

xiii 

1 ABBREVIATIONS 

2 AEA Atomic Energy Act 

3 ANSI American National Standards Institute 

4 Bq becquerel 

5 CFR Code of Federal Regulations

6 cpm counts per minute 

7 DOJ U.S Department of Justice 

8 ECD electron capture detector 

9 EPA U.S. Environmental Protection Agency 

10 FDA U.S. Food and Drug Administration

11 GPO Government Printing Office 

12 h hour 

13 IN Information Notice 

14 kBq kilobecquerel 

15 MSDS material safety data sheet 

16 MSTR Material Safety, States, Tribal, and Rulemaking 

17 NCRP National Council on Radiation Protection and Measurements 

18 NIST National Institute of Standards and Technology 

19 NMSS Office of Nuclear Material Safety and Safeguards 

20 NRC U.S. Nuclear Regulatory Commission 

21 OCFO Office of the Chief Financial Officer 

22 OMB Office of Management and Budget 

23 PET positron emission tomography 

24 PII Personally Identifiable Information 

25 QA quality assurance 

26 QC quality control 

27 R roentgen 

28 RIS regulatory issue summary 

29 RSO radiation safety officer 

30 RG regulatory guide 

31 SI International System of Units (abbreviated SI from the French Le Systeme 

32 Internationale d'Unites) 

33 SSD sealed source and device 

34 Sv sievert 

35 std standard 

36 U.S.C. United States Code 

37 μCi microcurie

1-1 

1 1 PURPOSE OF REPORT 

2 This report provides guidance to an applicant in preparing an exempt distribution license 

3 application and also provides U.S. Nuclear Regulatory Commission (NRC) staff with criteria for 

4 evaluating an exempt distribution license application. 

5 Exempt distribution licenses authorize the initial distribution of byproduct material or source 

6 material to persons exempt from the requirements (exempt distribution) for an NRC license 

7 under Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR 30.14, 10 CFR 30.15, 

8 10 CFR 30.18, 10 CFR 30.19, 10 CFR 30.20, 10 CFR 30.21, 10 CFR 30.22, and 

9 10 CFR 40.13(c) and exempt from licensing requirements under the equivalent provisions in 

10 Agreement State regulations. 

11 This report identifies the information needed to complete NRC Form 313, “Application for 

12 Materials License,” (see Appendix A in this NUREG) for the use of byproduct material or source 

13 material contained in products distributed to persons without a license. The information 

14 collection requirements in 10 CFR Parts 30, 32, and 40 and NRC Form 313 have been 

15 approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, 

16 3150-0001, 3150-0020, and 3150-0120, respectively. 

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

18  Regulations—references the regulations applicable to the item 

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

20  Discussion—provides additional information about the topic 

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

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

23 licensing process 

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

25 Form 313. 

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

27 Items 5 and 6, as indicated on the form. Applicants should address those items on separate 

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

29 the convenience and streamlined handling of exempt distribution licensing applications, the 

30 licensee should view the detailed source and product information for the distribution license as 

31 outlined in the applicable section of 10 CFR Part 32 or Part 40 and discussed in Chapter 9, 

32 “Information Required for Specific Types of Distribution Licenses,” of this NUREG. 

33 In this document, “dose” or “radiation dose” means absorbed dose, dose equivalent, effective 

34 dose equivalent, committed dose equivalent, committed effective dose equivalent, or total 

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

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

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

38 10 CFR Part 20 sets dose limits in terms of rem (Sv), rather than rad or roentgen. When the 

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

40 assumed to equal 1 rem. For alpha- and neutron-emitting radioactive material, 1 rad is not 
1-2 

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

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

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

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

5 and neutrons.
2-1 

1 2 AGREEMENT STATES 

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

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

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

5 critical mass, which are used or possessed within their borders. 

6 However, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 

7 10 CFR 150.15(a)(6), persons in Agreement States are not exempt from NRC licensing and 

8 regulatory requirements with respect to the initial transfer of any equipment, device, commodity, 

9 or other product containing source material or byproduct material whose subsequent 

10 possession, use, transfer, and disposal by all other persons are exempted from NRC licensing 

11 and regulatory requirements. Only the NRC has the regulatory authority to issue exempt 

12 distribution licenses authorizing the distribution of byproduct material or source material to 

13 persons exempt from the requirements (exempt distribution) for an NRC license under 

14 10 CFR 30.14, 10 CFR 30.15, 10 CFR 30.18, 10 CFR 30.19, 10 CFR 30.20, 10 CFR 30.21, 

15 10 CFR 30.22, or 40.13(c) and exempt from licensing requirements under the equivalent 

16 provisions in Agreement State regulations. All exempt distribution licenses are issued by 

17 NRC headquarters. 

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

1 Exempt distribution licenses do not authorize possession of licensed materials; thus, possession 

2 licenses are also required and are issued separately. Any applicant, other than a Federal entity, 

3 who wishes to possess or use licensed material in one of these Agreement States should 

4 contact the responsible officials in that State for guidance on preparing an application. These 

5 applications should be filed with State officials, not with the NRC. In areas under exclusive 

6 Federal jurisdiction within an Agreement State, NRC continues to be the regulatory authority. 

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

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

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

recognized Indian Tribes.2 10 

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

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

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

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

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

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

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

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

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

20 regulatory authority. 

Table 2-1. Who Regulates the Possession and Use 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 10 CFR 30.12, “Persons using byproduct 

material under certain Department of Energy and Nuclear Regulatory 

Commission contracts;” also, see 10 CFR 40.11, if applicable) 

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 

 

2

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

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

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

www.bia.gov. 
2-3 

Table 2-1. Who Regulates the Possession and Use Activity? 

Applicant and Proposed Location of Work 

Regulatory 

Agency 

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

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

to exclusive Federal jurisdiction 

Agreement 

State4

Non-Federal entity in Agreement State at federally controlled site subject to 

exclusive Federal jurisdiction NRC 

Non-Federal entity in Agreement State using radioactive materials (except 

industrial radiography) directly connected with 10 CFR Part 50 or 52 reactor 

operations or needed during the construction and preoperational phases of 

a reactor. 

NRC 

Non-Federal entity in Agreement State using radioactive materials not

directly connected with 10 CFR Part 50 or 52 reactor operations or needed 

during the construction and preoperational phases of a reactor. 

Agreement 

State4

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

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

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

 

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. 

3-1 

1 3 MANAGEMENT RESPONSIBILITY 

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

3 program management is vital to achieving safe, secure, and compliant operations. Consistent 

4 compliance with NRC regulations provides reasonable assurance that licensed activities will be 

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

6 and compliance. 

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

radiation safety program and to the individuals who are responsible for those processes and 

who have authority to provide necessary resources to achieve regulatory compliance. 

7 3.1 Commitments and Responsibilities 

8 In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR 30.32(c) and 

9 10 CFR 40.31(b), each application must be signed by the applicant or licensee or a person duly 

10 authorized to act for and on behalf of the applicant or licensee. If it is not clear whether the 

11 application was signed by someone duly authorized to act for and on the behalf of the applicant 

12 or licensee, NRC license reviewers may ask for additional assurances that the individual that 

13 signed the application is duly authorized to act for and on behalf of the applicant or licensee. 

14 The signature on an application acknowledges the licensee’s commitments and responsibilities 

15 for the following: 

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

17 with regulations 

18  completeness and accuracy of the radiation safety records and all information 

19 provided to the NRC (10 CFR 30.9 and 10 CFR 40.9, “Completeness and accuracy 

20 of information”) 

21  knowledge about the contents of the license and application 

22  compliance with current NRC regulations, the licensee’s procedures, and NRC license 

23 commitments 

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

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

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

27 is maintained 

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

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

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

31 and responsibilities 

32  commitment to ensure that radiation workers have adequate training 

33  prevention of discrimination of employees engaged in protected activities and 

34 commitment to provide information to employees about employee protection provisions 

35 (10 CFR 30.7, and 10 CFR 40.7, “Employee protection”) 
3-2 

1  commitment to provide information to employees about deliberate misconduct provisions 

2 (10 CFR 30.10 and 10 CFR 40.10 “Deliberate misconduct”) 

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

4 license (see Section 11.1, “Timely Notification of Transfer of Control,” of this NUREG) 

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

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

7 or 10 CFR 40.41(f)], as discussed further in Section 11.2, “Notification of Bankruptcy 

8 Proceedings,” of this NUREG 

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

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

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

12 3.2 Safety Culture 

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

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

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

16 to all licensees; certificate holders; permit holders; authorization holders; holders of quality 

17 assurance program approvals; vendors and suppliers of safety-related components; and 

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

19 subject to NRC authority. 

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

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

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

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

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

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

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

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

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

29 from the NRC’s safety culture policy statement. 

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

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

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

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

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

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

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

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

38 with NRC-regulated activities. 

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

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

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

42 Safety Culture Policy Statement and traits are not incorporated into the regulations. Safety 

43 culture traits may be inherent to an organization’s existing radiation safety practices and 
3-3 

1 programs. For instance, licensees that incorporate tritium in the form of paint in radiation 

2 measuring instruments and timepieces must follow quality control procedures in the fabrication 

3 of production lots to ensure that the quality control standards are met. The need to follow 

4 quality control procedures may correspond with the safety culture traits specified in Table 3-1 as 

5 “Work Processes” (the process of planning and controlling work activities is implemented so that 

6 safety is maintained). However, licensees should be aware that this is just an example and 

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

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

9 and functions. 

10 Refer to Appendix G of this NUREG for the NRC’s Safety Culture Policy Statement. More 

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

12 http://www.nrc.gov/about-nrc/safety-culture.html. 

Table 3-1. Traits of a Positive Safety Culture 

Leadership Safety Values

and Actions

Problem Identification and 

Resolution Personal Accountability

Leaders demonstrate a 

commitment to safety in their 

decisions and behaviors. 

Issues potentially impacting 

safety are promptly identified, 

fully evaluated, and promptly 

addressed and corrected 

commensurate with their 

significance. 

All individuals take personal 

responsibility for safety. 

Work Processes Continuous Learning

Environment for Raising 

Concerns

The process of planning and 

controlling work activities is 

implemented so that safety is 

maintained. 

Opportunities to learn about 

ways to ensure safety are 

sought out and implemented. 

A safety conscious work 

environment is maintained 

where personnel feel free to 

raise safety concerns without 

fear of retaliation, 

intimidation, harassment, or 

discrimination. 

Effective Safety 

Communications

Respectful Work 

Environment Questioning Attitude

Communications maintain a 

focus on safety. 

Trust and respect permeate 

the organization. 

Individuals avoid 

complacency and 

continuously challenge 

existing conditions and 

activities in order to identify 

discrepancies that might 

result in error or inappropriate 

action. 

4-1 

1 4 APPLICABLE REGULATIONS 

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

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

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

5 Federal Regulations (10 CFR) contain regulations applicable to licensing of byproduct and 

6 source material and exempt distribution licensing, as well as exemptions from licensing of 

7 byproduct and source material. Some of these parts are specific to one type of license, while 

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

9 Regulations in 10 CFR Part 30 provide exemptions from the requirements for an NRC license to 

10 persons who receive, possess, use, transfer, own, or acquire byproduct material in exempt 

11 products such as silicon chips, electron tubes, check sources, gunsights, and smoke detectors. 

12 The NRC applies regulatory control on the distribution of products to persons exempt from the 

13 requirements for a license through specific requirements on distributors, as defined in Subpart 

14 A, “Exempt Concentrations and Items,” of 10 CFR Part 32. 

15 Regulations in 10 CFR Part 40 provide exemptions from the requirements for an NRC license to 

16 persons who receive, possess, use, transfer, own, or acquire source material in such products 

17 as welding rods, gas mantles, piezoelectric ceramic, and glassware. The NRC applies 

18 regulatory control on the distribution of products to persons exempt from the requirements for a 

19 license through specific requirements on distributors of source material in 10 CFR 40.52. 

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

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

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

23 links to the rules: 

24  10 CFR Part 2 “Rules of Practice for Domestic Licensing Proceedings and 

25 Issuance of Orders” 

26  10 CFR Part 19 “Notices, Instructions and Reports to Workers: Inspection 

27 and Investigations” 

28  10 CFR Part 20 “Standards for Protection Against Radiation” 

29  10 CFR Part 21 “Reporting of Defects and Noncompliance” 

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

31 Byproduct Material” 

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

33 Items Containing Byproduct Material” 

34  10 CFR Part 40 “Domestic Licensing of Source Material” 

35  10 CFR Part 71 “Packaging and Transportation of Radioactive Material” 

36  10 CFR Part 110 “Export and Import of Nuclear Equipment and Material” 
4-2 

1  10 CFR Part 150 “Exemptions and Continued Regulatory Authority in Agreement 

2 States and in Offshore Waters Under Section 274” 

3  10 CFR Part 170 “Fees for Facilities, Materials, Import and Export Licenses, and 

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

5 as Amended” 

6  10 CFR Part 171 “Annual Fees for Reactor Licenses, and Fuel Cycle Licenses and 

7 Materials Licenses, Including Holders of Certificates of 

8 Compliance, Registrations, and Quality Assurance Program 

9 Approvals and Government Agencies Licensed by the NRC” 

10 Copies of the above documents may be obtained by calling the Government Printing Office 

11 Customer Contact Center toll-free at 866-512-1800, in Washington, DC; calling 202-512-1800; 

12 or ordering online at http://bookstore.gpo.gov. 

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

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

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

16 Web site at http://www.nrc.gov. Regulations are periodically amended, and the NRC 

17 (as well as all other Federal agencies) is required to publish notice of such amendments in the 

18 Federal Register. 
5-1 

1 5 EXEMPT DISTRIBUTION 

2 5.1 General

3 Exemptions from licensing requirements are based on a determination by the Commission that 

4 the exempted classes of products or types of uses will not constitute an unreasonable risk to the 

5 common defense or security or to public health and safety, nor constitute a frivolous use of 

6 radioactive material. Radiation safety is primarily dependent on safety features built into the 

7 sealed source or device or on restrictions on the amount of radioactive material that can be 

8 initially distributed. 

9 Regulations in Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR Part 30 provide 

10 such an exemption from the requirements for an U.S. Nuclear Regulatory Commission (NRC) 

11 license to persons who receive, possess, use, transfer, own, or acquire byproduct material in 

12 exempt products such as silicon chips, electron tubes, check sources, gunsights, and smoke 

13 detectors. The NRC applies regulatory control on the distribution of products to persons exempt 

14 from the requirements for a license through specific requirements on distributors, as defined in 

15 Subpart A, “Exempt Concentrations and Items,” of 10 CFR Part 32. 

16 Regulations in 10 CFR Part 40 provide such an exemption from the requirements for an NRC 

17 license to persons who receive, possess, use, transfer, own, or acquire source material in such 

18 products as welding rods, gas mantles, piezoelectric ceramic, and glassware. The NRC applies 

19 regulatory control on the distribution of products to persons exempt from the requirements for a 

20 license through specific requirements on distributors of source material in 10 CFR 40.52. 

21 Generally, distribution of byproduct or source material to persons exempt from licensing 

22 requirements can only be conducted by persons who have a specific license from the NRC 

23 authorizing such distribution to persons exempt from the requirements for an NRC license. 

24 Except as provided in 10 CFR 30.18(a) and 10 CFR 30.14(c), these exemptions do not apply to 

25 persons who manufacture, process, produce, incorporate byproduct material into, initially 

26 transfer for sale, or distribute products containing byproduct material. In the case of 

27 10 CFR 30.18, it is commercial distribution that requires a license; noncommercial initial 

28 transfers do not require a 10 CFR 32.18 license. 10 CFR 30.14(c) also exempts distributors of 

29 products or materials if the byproduct material has been introduced by another person licensed 

30 under 10 CFR 32.11. The exemptions in 10 CFR 40.13(c) do not apply to those who initially 

31 transfer for sale or distribution a product containing source material. Those engaged in these 

32 activities must be licensed to initially transfer or distribute to persons exempt from licensing. 

33 The distributor is required to ensure to the NRC that all products are manufactured, tested, and 

34 distributed in accordance with the specifications provided in its license application. These 

35 specific licenses are issued by the NRC and are referred to as “exempt distribution” or 

36 “E” licenses. 

37 With limited exceptions, persons authorized to initially transfer or distribute to persons exempt 

38 from licensing must have a separate license authorizing the possession or use of radioactive 

39 material from the NRC or an Agreement State before an exempt distribution license will be 

40 issued (Section 5.4, “Possession Licenses”). 

41 5.2 Quality Assurance/Quality Control Programs

42 Quality control (QC) procedures to be followed in the fabrication of the product and the QC 

43 standards the product will be required to meet are required to be submitted for certain products 
5-2 

1 under 10 CFR 32.14 and 40.52 and all products under 10 CFR 32.22, 10 CFR 32.26, and 

2 10 CFR 32.30. Applicants should develop and implement a QC program that will ensure that 

3 the product is manufactured in accordance with the information and representations made in 

4 the application. 

5 Applicants may submit a quality assurance (QA) program instead of or in conjunction with a QC 

6 program. The QA program should provide control over all activities applicable to the design, 

7 fabrication, inspection, testing, maintenance, repair, modification, and distribution of the devices 

8 that contain byproduct material. NUREG-1556, Volume 3, “Consolidated Guidance About 

9 Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration,” 

10 also provides information necessary to establish and implement a QA program that 

11 encompasses all of the QA and QC requirements necessary for the manufacture and 

12 distribution of sealed sources and devices. 

13 Applicants should note that the information in this NUREG is not a substitute for developing and 

14 implementing an effective program for the manufacture and distribution of exempt products. 

15 However, if an application incorporates by reference procedures in this or any other guidance 

16 document, then those procedures become a part of the license conditions and regulatory 

17 requirements. For example, if an application or license amendment states that “the 

18 manufacturer will follow the acceptance sampling requirements for removable contamination 

19 and design conformity as outlined in NUREG-1556, Volume 3,” then the licensee should adhere 

20 to the specifications contained in the referenced document. 

21 5.3 Licensing and Registration

22 Applicants are required to provide specific information about the sources and products as 

23 outlined in 10 CFR 32.11, 10 CFR 32.14, 10 CFR 32.18, 10 CFR 32.21, 10 CFR 32.22, 

24 10 CFR 32.26, 10 CFR 32.30, and 10 CFR 40.52, concerning, for example, the radionuclides 

25 and activities, containment and construction, labeling, quality control and assurance programs. 

26 The NRC will evaluate the information submitted in the application to ensure it meets all 

27 applicable standards and regulations and will contact the applicant, if necessary, to obtain 

28 additional clarification or information. The Division of Material Safety, States, Tribal, and 

29 Rulemaking Programs (MSTR), Office of Nuclear Material Safety and Safeguards (NMSS), will 

30 perform a sealed source and device (SSD) safety evaluation on the devices to be distributed, in 

31 accordance with 10 CFR 32.22, 10 CFR 32.26, or 10 CFR 32.30. The device evaluations will 

32 contain a review of the type and quantity of byproduct material, the chemical and physical form 

33 of the byproduct material, the solubility in water and body fluid of the byproduct material, the 

34 details of construction and design of the product, the degree of access of human beings to the 

35 product, the expected useful life of the product, the labeling of the product and point-of-sale 

36 package, the prototype testing procedures and results, the estimated doses and probabilities 

37 related to the safety criteria, the QA/QC procedures, and the proposed uses. Upon completion 

38 of the SSD evaluation, if requirements are met, the NRC will issue a registration certificate. 

39 Additional information about the review and approval process for SSDs is contained in 

40 NUREG-1556, Volume 3. 

41 After the issuance of a license, licensees must conduct their programs for the manufacture 

42 and/or distribution of exempt products, in accordance with the following: 

43  statements, representations, and procedures contained in their application, and other 

44 correspondence with NRC 
5-3 

1  terms and conditions of the license 

2  device registration, if applicable 

3  applicable NRC regulations, some of which are discussed below 

4 The regulations in 10 CFR 30.9, “Completeness and accuracy of information,” and 

5 40.9, “Completeness and accuracy of information,” in the case of source material, require that 

6 the information provided in the application be complete and accurate in all material respects. 

7 Information is considered to be material if it is likely to change or affect an Agency decision on 

8 issuing the license. Therefore, information should be clear, specific, and accurate. Regulations 

9 in 10 CFR 30.10 and 10 CFR 40.10 state that those providing information concerning a 

10 licensee’s activities may not deliberately engage in misconduct or provide incomplete or 

11 inaccurate information to the NRC. 

12 It is important that applicants and licensees understand that the information provided in an 

13 application and approved in the license is considered a limitation by the NRC on the licensee to 

14 engage only in those activities and products as described in the application or license. The 

15 NRC should be notified of any changes or additions to the information submitted in the 

16 application. While some changes may not result in an amendment to the license, licensees 

17 should not assume that an amendment is not needed or an amendment request has been 

18 granted until they receive a written confirmation in the form of a letter or license amendment. 

19 (See Chapter 11, “Amendments and Renewals to a License,” for further information on 

20 amendments and other changes that require reporting.) 

21 5.4 Possession Licenses

22 All 10 CFR Part 32 licensees must also meet the requirements of 10 CFR Part 30. This 

23 includes submitting any information required by 10 CFR 30.32, “Application for specific 

24 licenses.” The NRC’s licensing practice has been to issue a separate 10 CFR Part 30 license. 

25 Exempt distribution licenses only authorize the product(s) to be distributed to persons exempt 

26 from licensing and generally do not authorize possession or use of radioactive material by the 

27 distributor. Persons who manufacture, process, produce, or initially transfer for sale products 

28 containing byproduct material must meet the requirements of 10 CFR 30.33, “General 

29 requirements for issuance of specific licenses,” for possession and use of licensed material on 

30 Federal property in an Agreement State, or in any State subject to NRC jurisdiction. This 

31 means that they must be authorized under specific license for the possession and use of 

32 byproduct material. 

33 The various provisions for application for licenses to distribute products for use under an 

34 exemption from licensing also indicate that the requirements of 10 CFR 30.33(a)(2) and (a)(3) 

35 do not apply to an application for a license to transfer byproduct material in such products or 

36 devices manufactured, processed, or produced under a license issued by an Agreement State. 

37 In this case, a separate 10 CFR Part 30 license issued by the NRC is not required; instead, a 

38 license for possession and use must first be issued by the appropriate Agreement State agency. 

39 Similarly, persons who initially transfer for sale “exempt” products containing source material 

40 must meet the general requirements of 10 CFR 40.32, “General requirements for issuance of 

41 specific licenses” for possession and use of licensed material on Federal property in an 

42 Agreement State, or in any State subject to NRC jurisdiction. However, in accordance with 

43 10 CFR 40.52(a), importers of finished products containing source material are exempt from 
5-4 

1 10 CFR 40.32(b) and (c) and 10 CFR Parts 19 and 20—this is different than the regulations 

2 governing the initial transfer of byproduct material. In the unique situation of importation of 

3 finished products containing source material with no further modification, a possession license is 

4 not required; only a distribution license is required. 

5 Otherwise, applicants for exempt distribution licenses may need to file a separate application for 

6 a specific license authorizing possession and use of byproduct or source material, incident to 

7 distribution, with the NRC Regional Office or the Agreement State for the State in which the 

8 material will be possessed and/or used. The Regional Office addresses are provided on NRC 

9 Form 3, in 10 CFR Part 20, Appendix D, “United States Nuclear Regulatory Commission 

10 Regional Offices,” and in Figure 2-1 of this NUREG. With the exception noted above, an 

11 exempt distribution license cannot be issued until the applicant obtains a possession and 

12 use license. 

13 5.5 Product Transfer Reports

14 Licensees are required to file a report concerning the types and quantities of byproduct or 

15 source material or products, covering the preceding calendar year, by January 31 of each year. 

16 Licensees who permanently discontinue activities authorized by an exempt distribution license 

17 must also file a report for the current calendar year within 30 days after ceasing distribution. 

18 Material transfer reports are required for licenses issued under 10 CFR 32.11, 10 CFR 32.14, 

19 10 CFR 32.18, 10 CFR 32.22, 10 CFR 32.26, 10 CFR 32.30, and 10 CFR 40.52, but not for 

20 licenses issued under 10 CFR 32.21. There is some variation in the specific contents required 

21 for these reports, and attention should be paid to the specific requirements in the relevant 

22 sections of the regulations in 10 CFR 32.12, 10 CFR 32.16, 10 CFR 32.20, 10 CFR 32.25(c), 

23 10 CFR 32.29(c), 10 CFR 32.32(c), or 10 CFR 40.53(c). More details concerning these reports 

24 and associated recordkeeping requirements are included in Appendix B of this report. 

25 5.6 Foreign Vendors

26 The provisions of 10 CFR 110.53(a) require a foreign vendor to establish an address in the 

27 United States to which the NRC can correspond and serve papers as necessary and perform 

28 periodic inspections to accomplish its mission. An exempt distribution license will not be issued 

29 to a foreign vendor, unless the requirements set forth in 10 CFR 110.53, “United States 

30 address, records, and inspections,” have been satisfied. The inspections will include, but will 

31 not be limited to, reviews of records and documentation maintained of exempt distribution 

32 activities; access to these records is imperative. 
6-1 

1 6 HOW TO FILE 

2 6.1 Application Preparation 

3 Applicants for a materials license should do the following: 

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

5  Complete U.S. Nuclear Regulatory Commission (NRC) Form 313 (Appendix A) Items 1 

6 through 4, 12, and 13, on the form itself. A link to the form is available at 

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

8  Complete NRC Form 313 Items 5 through 6, on supplementary pages. 

9  NRC Form 313 Items 7 through 11 are not applicable to an exempt distribution license; 

10 these items are covered by the possession and use license. 

11  Submit detailed source and product information for the distribution license as outlined in 

12 the applicable section of Title 10 of the Code of Federal Regulations (10 CFR) 

13 10 CFR Part 32 or Part 40 and discussed in Chapter 9, “Information Required for 

14 Specific Types of Distribution Licenses,” of this document. 

15  For each separate sheet other than NRC Form 313 submitted with the application, 

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

17 or the topic to which it refers. 

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

19 submitted, proprietary information and other sensitive information (e.g., personal privacy 

20 and security related) should be clearly identified according to 10 CFR 2.390, “Public 

21 inspections, exemptions, requests for withholding” (see Section 6.4, “Identifying and 

22 Protecting Sensitive Information”). 

23 Please note that if it is necessary when filing for a license to reference information contained in 

24 other licensees’ file(s) or registration certificate(s), whether current, retired, or inactive, the 

25 information should be submitted, in its entirety, as part of the application. 

26 6.2 Where To File 

27 NRC’s headquarters office issues all exempt distribution licenses. 

28 Requests for exempt distribution licenses and safety evaluations of sealed sources and devices 

29 for exempt products are submitted directly by applicants to the Division of Material Safety, State, 

30 Tribal, and Rulemaking Programs, Office of Nuclear Material Safety and Safeguards, 

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

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

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

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

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

36 States. Note that all materials applications for possession and use licenses are submitted to 
6-2 

1 Regions I, III, or IV. All applicants for materials for possession and use licenses located in the 

2 Region II geographical area should send their applications to Region I. 

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

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

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

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

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

8 Offices and Agreement States,” for additional information. 

9 6.3 Paper Applications 

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

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

12 applicants should do the following: 

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

14 into a document scanner. 

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

16  Use 11-point or larger font. 

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

18  Ensure that the print is clear and sharp. 

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

20 is best). 

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

required by 10 CFR 30.32(c) or 10 CFR 40.31(b) (see Section 8.8, “Certification”). 

21 6.4 Electronic Applications 

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

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

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

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

26 signatures, and the treatment of non-public information. 

27 6.5 Identifying and Protecting Sensitive Information 

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

29 publicly available for review in the NRC’ Public Document Room and electronically at the NRC 

30 Library. For more information on the NRC Library, visit http://www.nrc.gov/. 

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

32 unauthorized disclosure to the public. License applications that contain sensitive information 
6-3 

1 should be marked as indicated below, in accordance with 10 CFR 2.390, before the information 

2 is submitted to the NRC. Key examples are as follows: 

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

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

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

6 substantial delays in processing the application. Appendix H includes a checklist for 

7 requests for withholding information from public disclosure. 

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

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

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

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

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

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

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

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

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

17 2013-22, “Recent Licensing Submittals Containing Personally Identifiable Information,” 

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

19 Web page under “Regulatory Issue Summaries and Information Notices” at 

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

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

22 changed its procedures to avoid release of information that terrorists could use to plan or 

23 execute an attack against facilities or citizens in the United States. As a result, certain 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

38 information on procedures and any updates are available at 

39 http://www.nrc.gov/reading-rm/sensitive-info.html.

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

41 These include 

42  trade secrets and commercial or financial information 

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

44 party other than an agency in litigation with NRC 
6-4 

1  certain records or information compiled for law enforcement purposes 

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

3 concerning wells 

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

5 clearly unwarranted invasion of personal privacy 

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

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

8 regulation is available electronically on the NRC Web site at http://www.nrc.gov/reading-rm/doc9 collections/cfr. 

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

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

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

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

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

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

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

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

18 proprietary status of the information. 

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

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

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

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

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

24 http://www.nrc.gov/reading-rm/doc-collections/management-directives/. 
6-5 

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

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

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

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

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

have signed the appropriate agreements for handling proprietary information. 

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

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

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

that NRC may have cause to review this determination in the future; for example, if the scope 

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

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

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

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

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

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

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

such information from public disclosure. 

7-1 

1 7 APPLICATION AND LICENSE FEES 

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

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

4 fees for materials licenses and other regulatory services, including inspections, and import and 

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

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

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

8 begun, no fees will be refunded; application fees will be charged, regardless of the NRC’s 

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

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

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

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

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

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

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

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

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

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

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

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

8-1 

1 8 CONTENTS OF AN APPLICATION 

2 The following information applies to the indicated items on U.S. Nuclear Regulatory Commission 

3 (NRC) Form 313 (Appendix A of this NUREG). 

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

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

6 8.1 Item 1: License Action Type 

7 Item 1 of NRC Form 313 states the following: 

8 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 

9 Check Box A for a new license request. 

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 “Amendments and Renewals to a License” in Chapter 11 of this NUREG. 

13 8.2 Item 2: Name and Mailing Address of Applicant 

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

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

16 a licensee. An individual may be designated as the applicant only if the individual is acting in a 

17 private capacity and the distribution of the radioactive material is not connected with 

18 employment in a corporation or other legal entity. Provide the mailing address where 

19 correspondence should be sent. A post office box number is an acceptable mailing address. 

20 In the case of distribution of exempt products, it may be important to consider which locations 

21 are designated as the “licensed facility” and which locations are not. This is relevant to the point 

22 at which a product is covered by the exemption. The following paragraphs describe how. 

23 A manufacturer/distributor may send its finished product directly to an exempt entity, or it may 

24 send its product to a warehouse that does not take any further action with regard to that product 

25 other than to serve as a location for storage prior to further distribution. 

26 As long as the warehouse is only used for storage of the product (i.e., the product is not being 

27 further used, modified, or packaged), the warehouse is exempt from the regulations governing 

28 licensing and does not need a possession license to further distribute the product; nor does the 

29 warehouse location need to be listed on the exempt-distribution license. However, if initial 

30 transfer does not occur until the product leaves the company’s warehouse, the applicant would 

31 have to obtain a possession license, and the warehouse would need to be listed on the 

32 exempt-distribution license. 
8-2 

1 Note: Please see Section 5.7, “Foreign Vendors,” for requirements for maintaining a physical 

2 address in the United States.

3 Note: An applicant must have a U.S. address in order for the NRC to issue it a license. The 

4 licensee’s mailing address may be based on an address located in the territories of Puerto Rico, 

5 Guam, the U.S. Virgin Islands, American Samoa, or the Northern Mariana Islands. 

6 Notify the NRC of changes in mailing address; these changes do not require a fee. 

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

8 transferred (see Section 11.1, “Timely Notification of Transfer of Control”). The NRC must also 

9 be notified when bankruptcy proceedings have been initiated (see Section 11.2, “Notification of 

10 Bankruptcy Proceedings”). 

11 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or 

12 Possessed 

13 An applicant for an exempt distribution license must be an organization with an address in the 

14 United States at which it will receive, possess, and perform quality control checks on the 

15 products authorized for distribution and maintain records relating to NRC-related activities, and 

16 from which it will distribute the items. Specify the street address, city, and State or other 

17 descriptive address (e.g., Highway 10, 5 miles east of the intersection of Highway 10 and State 

18 Route 234, Anytown, State) for each facility. The descriptive address should be sufficient to 

19 allow an NRC inspector to find the facility location. A post office box address is not acceptable 

20 (see Figure 8-1). In addition, applicants are encouraged to provide global positioning system 

21 coordinates, as appropriate. 

22 A license amendment is required before distributing licensed material at an address or location 

23 not already listed on the license. 

24 Note: If the addresses listed are in Agreement States, an exempt distribution license will not be 

25 issued or amended until a copy of the corresponding possession license(s) has been provided 

26 to the NRC. 
8-3 

An acceptable location of distribution specifies street address, city, State, 

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

Figure 8-1. Location of Distribution

1 

2 

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

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

5 “Security-Related Information—Withhold Under 10 CFR 2.390.” See Section 6.4, “Identifying 

6 and Protecting Sensitive Information,” for more details. 

7 8.4 Item 4: Person To Be Contacted About This Application 

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

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

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

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

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

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

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

15 change is only in order to provide information and would not be considered an application for 

16 license amendment. 

As indicated on NRC Form 313 (see Appendix A of this NUREG), Items 5 and 6 should be 

submitted on separate sheets of paper. 

RPh17a.ppt

082898

32 Elm St.

City, ST 12345 P.O. Box XXXX

City, ST 12345

32 ELM St.

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

or local regulations. 
8-4 

1 8.5 Item 5: Radioactive Material 

2 Applicants should determine what devices or products are to be distributed and provide 

3 information about each type of product, a list of the radionuclides (include manufacturer’s name 

4 and model number, if applicable), the physical form, and the maximum activity of radioactive 

5 material that will be used in each source for each product type. Activity may be specified either 

6 in terms of becquerels or in terms of curies. For some products containing source material, the 

7 weight in grams may be acceptable. For example, the maximum activity per check source is 

8 0.37 gigabecquerels or 10 microcuries of cesium-137. 

9 8.6 Item 6: Purpose(s) For Which Licensed Material Will Be Used 

10 Describe in general terms the purpose(s) for which the byproduct or source material will be used 

11 (detailed information about the final product to be distributed is discussed in Section 9); for 

12 example, an americium-241 foil source to be incorporated into a smoke detection device for 

13 distribution to persons exempt from licensing. 

14 8.7 Item 12: License Fees 

15 On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of 

16 the fee enclosed with the application. 

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

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

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

20 800 368-5642, extension 415-7554. The e-mail address for fees questions is 

21 Fees.Resource@nrc.gov. 

22 8.8 Item 13: Certification

23 A representative of the corporation or legal entity filing the application should sign and date 

24 NRC Form 313. The representative signing the application must be authorized to make binding 

25 commitments and to sign official documents on behalf of the applicant. As discussed previously 

26 in Chapter 3, “Management Responsibility,” signing the application acknowledges 

27 management’s commitment to and responsibility for the radiation protection program. The NRC 

28 will return all unsigned applications for proper signature. 

29 Notes:

30  It is a criminal offense to knowingly and willfully make a false statement or 

31 representation on applications or correspondence (18 U.S.C. 1001). 

32  When an application references commitments, those items will be incorporated into the 

33 license and, therefore, become binding regulatory requirements. 
9-1 

1 9 INFORMATION REQUIRED FOR SPECIFIC TYPES OF DISTRIBUTION 

2 LICENSES 

3 Note: The U.S. Nuclear Regulatory Commission (NRC’s) policy is to issue separate possession 

4 and distribution licenses. If you plan to possess and distribute from an Agreement State, you 

5 must obtain a possession license from the Agreement State in addition to a distribution license 

6 from the NRC.

7 9.1 10 CFR 32.11: Exempt Concentrations 

8 Regulations: 10 CFR 30.14, 10 CFR 30.70, 10 CFR 32.11, 10 CFR 32.12, 10 CFR 32.13 

9 Criteria: Applicants for a specific license to introduce byproduct material into a product or 

10 material owned by or in the possession of the licensee or another, or transfer of ownership or 

11 possession of the product or material containing the byproduct material, for use under Title 10 of 

12 the Code of Federal Regulations (10 CFR) 10 CFR 30.14 or equivalent regulations of an 

13 Agreement State, apply under 10 CFR 32.11. 

14 Example products: 

15  silicon chips or wafers 

16  gemstones, such as topaz 

17 The applicant must obtain a specific license under 10 CFR 32.11 to introduce byproduct 

18 material into a product or material owned by or in the possession of the licensee or any other 

19 person and the transfer of ownership or possession of the product or material containing the 

20 byproduct material for use under the exemption in 10 CFR 30.14. A sealed source and device 

21 review and issuance of a certificate of registration are not required for these materials. 

22 As stated in 10 CFR 30.14(d) and 10 CFR 32.13, the introduction of byproduct material into a 

23 product or material is prohibited if there is knowledge or reason to believe that the product will 

24 be distributed or transferred to persons exempt from the requirements for a license under 

25 10 CFR 30.14, except in accordance with a license issued under 10 CFR 32.11. 

26 Paragraph (a) of 10 CFR 32.11 indicates that the applicant must satisfy the general 

27 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

28 information concerning possession license requirements. 

29 Paragraph (b) of 10 CFR 32.11 requires the applicant to provide sufficient information regarding 

30 the product pertinent to the evaluation of the potential radiation exposures, including: 

31  a description of the product or material into which the byproduct material will 

32 be introduced 

33  intended use of the byproduct material and the product or material into which it 

34 is introduced 

35  method of introduction 

36  initial concentration of the byproduct material in the product or material 
9-2 

1  control methods to assure that no more than the specified concentration is introduced 

2 into the product or material 

3  estimated time interval between introduction and transfer of the product or material 

4  estimated concentration of the radioisotopes in the product or material at the time 

5 of transfer 

6 Paragraph (c) of 10 CFR 32.11 requires the applicant to provide reasonable assurance that 

7  the concentrations of byproduct material at the time of transfer will not exceed the 

8 concentrations in 10 CFR 30.70 

9  reconcentration of the byproduct material in concentrations exceeding those in 

10 10 CFR 30.70 is not likely 

11  use of lower concentrations is not feasible 

12  the product or material is not likely to be incorporated in any food; beverage; cosmetic; 

13 drug; or other commodity or product designed for ingestion or inhalation by, or 

14 application to, a human being 

15 The requirements for records and reporting are specified in 10 CFR 32.12. Information 

16 concerning the recordkeeping and reporting requirements are not required to be included in the 

17 application, because the requirements are fully specified in the regulations. However, 

18 applicants need to be aware of these responsibilities. Details concerning recordkeeping and 

19 annual reporting requirements can be found in Appendix B of this report. 

20 Discussion: Applicants should request authorization only for the isotope(s) that are of interest. 

21 When appropriate, it is acceptable to reference the byproduct material as “all isotopes not to 

22 exceed the activity concentrations listed in 10 CFR 30.70. 

23 When the byproduct material in concentrations not exceeding the limits set in 10 CFR 30.70 is 

24 to be initially transferred, 10 CFR 30.14(d) and 32.13 apply, and the manufacture, transfer, or 

25 distribution to persons exempt from licensing requirements must be specifically licensed. The 

26 information required by 10 CFR 32.11(b) and (c) provides the basis for determining whether the 

27 products or materials described in 10 CFR 30.14(a) may be transferred to persons exempt from 

28 the requirements for a license to the extent that such person receives, possesses, uses, 

29 transfers, owns, or acquires those products or materials. Therefore, each person engaging in 

30 the initial transfer or distribution of such exempt materials must have a license authorizing 

31 distribution under 10 CFR 32.11. 

32 Unique aspects of the exemption for exempt concentrations (10 CFR 30.14) 

33 An exemption is provided by 10 CFR 30.14(c) for a manufacturer, processor, or producer of a 

34 product or material to transfer byproduct material contained in a product or material in 

35 concentrations not in excess of those specified in 10 CFR 30.70 and introduced into the product 

36 or material by a licensee holding a specific license issued by the NRC expressly authorizing 

37 such introduction (i.e., a 10 CFR 32.11 license). This is because the original use of this 

38 provision was for tracers for such purposes as quality control, where a licensee was qualified to 
9-3 

1 ensure safety and that the concentrations met regulatory limits. However, the “introducer” 

2 licensed under 10 CFR 32.11 was not necessarily the same entity distributing the product. 

3 Because it is a general materials exemption, rather than being limited to specific products, 

4 10 CFR 30.14(c) also indicates that it does not apply to the transfer of byproduct material 

5 contained in any food; beverage; cosmetic; drug; or other commodity or product designed for 

6 ingestion or inhalation by, or application to, a human being. 

7 This exemption is also unique in that the “introducer” applicant for a 10 CFR 32.11 license must 

8 show that reconcentration of the byproduct material in concentrations exceeding those in 

9 10 CFR 30.70 is not likely. 

10 Note: Although applicants are not required to provide estimation of likely exposures, the 

11 exempt concentration provision has been identified as one that may need careful consideration 

12 of potential doses to the public. This is because the actual concentration limits of external 

13 emitters, if used in large quantities, could allow for doses higher than appropriate for materials 

14 to be used under exemption from licensing, particularly given that the radioactivity normally 

15 serves no purpose in the product. 

16 Gemstones 

17 The introduction of exempt concentrations of byproduct material into gemstones occurs as a 

18 result of irradiation using a reactor and/or an accelerator. Initial distributors of irradiated 

19 gemstones must obtain an exempt distribution license from NRC headquarters. For imported 

20 gemstones, the licensee may not be conducting the irradiation, but is introducing the activated 

21 products into the U.S. marketplace. Note that the exemption itself does not cover import 

22 [10 CFR 30.14(b)]. 

23 Distributors of gemstones must also request an exemption from 10 CFR 32.11(c) because 

24 gemstones are considered an application to human beings. Therefore, a dose assessment is 

25 required. In accordance with the Consumer Product Policy Statement [updated January 16, 

26 2014 (79 FR 2907)], adornments are considered of marginal benefit to society and can only be 

27 considered a justified practice if the potential doses are projected to be a very small fraction of 

28 the public dose limit. 

29 Appendix C of this NUREG contains specific information needed from importers and domestic 

30 producers of irradiated gemstones to support applications for licenses under 10 CFR 32.11, to 

31 distribute irradiated gemstones to persons exempt from licensing. 

32 Response from Applicant: 

33 An applicant should provide sufficient information relating to the materials or products into which 

34 byproduct material will be introduced and the methods of introduction and the control methods 

35 to demonstrate that the products will meet the applicable concentration limits set forth in the 

36 regulations. An applicant should 

37  Provide all of the information required as to the products it intends to distribute. 

38  Provide information on controls to ensure that concentrations of byproduct material in 

39 products or materials will not exceed applicable concentration limits at time of transfer. 
9-4 

1 Checklist for Applications under 10 CFR 32.11 

Item 

No. Suggested Response 

Description

Attached 

A Applicant satisfied general requirements in 10 CFR 30.33 

[licensee provides copy of possession and use license]. 

[ ] 

B Applicant provided sufficient information regarding the following: [ ] 

1. Product or material into which the byproduct material will be introduced [ ] 

2. Intended use of the byproduct material and the product or material into 

which it is introduced 

[ ] 

3. Method of introduction [ ] 

4. Initial concentration of the byproduct material in the product or material [ ] 

5. Control methods to assure that no more than the specified 

concentration is introduced into the product or material 

[ ] 

6. Estimated time interval between introduction and transfer of the product 

or material 

[ ] 

7. Estimated concentration of the radioisotopes in the product or material 

at the time of transfer 

[ ] 

C Applicant demonstrated reasonable assurance of the following: [ ] 

1. Concentrations of byproduct material at the time of transfer will not 

exceed the values in 10 CFR 30.70 

[ ] 

2. Reconcentration of the byproduct material in concentrations exceeding 

those in 10 CFR 30.70 is not likely 

[ ] 

3. Use of lower concentrations is not feasible [ ] 

4. Product or material is not likely to be incorporated in any food; 

beverage; cosmetic; drug; or other commodity or product designed for 

ingestion or inhalation by, or application to, a human being 

[ ] 

2 9.2 10 CFR 32.14: Certain Items Containing Byproduct Material 

3 Regulations: 10 CFR 30.15, 10 CFR 30.71, 10 CFR 32.14, 10 CFR 32.15, 10 CFR 32.16 

4 Criteria: Applicants for a specific license to apply byproduct material to, or to incorporate 

5 byproduct material into, or to initially transfer for sale or distribution, products containing 

6 byproduct material for use under 10 CFR 30.15 or equivalent regulations of an Agreement 

7 State, apply under 10 CFR 32.14. 

8 Applicants must obtain a specific license under 10 CFR 32.14 in order to distribute the following 

9 products containing byproduct material for use under the exemption in 10 CFR 30.15: 

10  Timepieces or hands or dials 

11  Certain static elimination devices 

12  Ion-generating tubes designed for ionization of air 

13  Certain ionization chamber smoke detectors 

14  Electron tubes 

15  Ionizing radiation measuring instruments containing calibration sources 
9-5 

Table 9-1. 10 CFR 30.15(a)(1) Timepieces or Hands or Dials

Radionuclide

Maximum 

Quantity

Per Timepiece

Maximum 

Quantity

Per Hand

Maximum 

Quantity

Per Dial & Bezel

Maximum Dose 

Rate 

Tritium 25 millicuries 

[925 MBq] per 

timepiece

5 millicuries 

[185 MBq] per 

hand

15 millicuries 

[555 MBq] per 

dial (include 

bezels when 

used)

For wrist watches, 

0.1 millirad per hour 

at 10 centimeters 

from any surface. 

For pocket watches, 

0.1 millirad per hour 

at 1 centimeter from 

any surface. 

For any other 

timepiece, 

0.2 millirad per hour 

at 10 centimeters 

from any surface. 

Promethium-147 100 

microcuries 

[3,700 MBq] 

per watch

or

200 

microcuries 

[7,400 MBq] 

per any other 

timepiece

20 microcuries 

[740 MBq] per 

watch hand

or

40 microcuries 

[1,480 MBq] 

per other 

timepiece hand

60 microcuries 

[2,220 MBq] per 

watch dial

or

120 microcuries 

[4,440 MBq] per 

other timepiece 

dial (include 

bezels when 

used)

Table 9-2. 10 CFR 30.15(a)(2)(i) Static Elimination Devices 

Radionuclide Maximum Quantity Per Device 

Polonium-210 18.5 megabecquerel [500 microcurie] 

Table 9-3. 10 CFR 30.15(a)(2)(ii) Ion-Generating Tubes Designed for Ionization of Air 

Radionuclide Maximum Quantity Per Device 

Polonium-210 18.5 megabecquerel [500 microcurie] 

Tritium 1.85 gigabecquerel [50 millicurie] 

Table 9-4. 10 CFR 30.15(a)(7) Ionization Chamber Smoke Detectors Designed to 

Protect Life and Property From Fires 

Radionuclide Maximum Quantity Per Detector 

Americium-241 1 microcurie (μCi) per detector in the form of a foil 

Table 9-5. 10 CFR 30.15(a)(8) Electron Tubes 

For purposes of this paragraph “electron tubes” include spark gap tubes, power tubes, gas 

tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pickup tubes, 

radiation detection tubes, and any other completely sealed tube that is designed to conduct or 

control electrical currents. 

1 
9-6 

Table 9-5. 10 CFR 30.15(a)(8) Electron Tubes 

Radionuclide Maximum Quantity Per Tube Maximum Dose Rate 

Tritium 150 millicuries [5,550 MBq] per 

microwave receiver protector tube 

The levels of radiation from each 

electron tube containing byproduct 

material do not exceed 1 millirad per 

hour at 1 centimeter from any 

surface when measured through 

7 milligrams per square centimeter 

of absorber. 

Tritium 10 millicuries [370 MBq] per any 

other electron tube 

Cobalt-60 1 microcurie [37 MBq] 

Nickel-63 5 microcuries [185 MBq] 

Krypton-85 30 microcuries [1,110 MBq] 

Cesium-137 5 microcuries [185 MBq] 

Promethium-147 30 microcuries [1,110 MBq] 

Table 9-6. 10 CFR 30.15(a)(9) Ionizing Radiation-Measuring Instruments for Purposes 

of Internal Calibration or Standardization 

For purposes of this paragraph, 0.05 microcurie of americium-241 is considered an exempt 

quantity under 10 CFR 30.71, “Schedule B” 

Radionuclide Maximum Quantity Per Instrument 

One or more 

sources of 

byproduct 

material. 

Each source contains no more than 

one exempt quantity set forth in 

10 CFR 30.71, and 

Each instrument contains no more 

than 10 exempt quantities. 

An instrument’s source(s) may 

contain either one type or different 

types of radionuclides and an 

individual exempt quantity may be 

composed of fractional parts of one 

or more of the exempt quantities in 

10 CFR 30.71, provided that the sum 

of such fractions shall not exceed 

unity. 

1 This section also contains exemptions for certain products manufactured before 

2 December 17, 2007: 

3  Balances of precision containing not more than 1 millicurie of tritium per balance or not 

4 more than 0.5 millicurie of tritium per balance part; and 

5  Marine compasses containing not more than 750 millicuries of tritium gas and other 

6 marine navigational instruments containing not more than 250 millicuries of tritium gas. 

7 As no new manufacture or initial distribution is allowed, these products will not be discussed 

8 further in this document. 

9 Paragraph (a) of 10 CFR 32.14 indicates that the applicant must satisfy the general 

10 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

11 information concerning possession license requirements. 
9-7 

1 The applicant should provide the following information about the product as outlined in 

2 10 CFR 32.14(b): 

3 Sufficient information regarding the product pertinent to the evaluation of the potential radiation 

4 exposures, including: 

5 (1) chemical and physical form and maximum quantity of byproduct material in 

6 each product 

7 (2) details of construction and design of each product 

8 (3) the method of containment or binding of the byproduct material in the product 

9 (4) except for electron tubes and ionization chamber smoke detectors and timepieces 

10 containing promethium-147 or tritium in the form of gaseous tritium light sources, 

11 procedures for and results of prototype testing to demonstrate that the byproduct 

12 material will not become detached from the product and that the byproduct material will 

13 not be released to the environment under the most severe conditions likely to be 

14 encountered in normal use of the product 

15 (5) in the case of ionizing radiation-measuring instruments and timepieces containing 

16 tritium in the form of paint, quality control procedures to be followed in the fabrication of 

17 production lots of the product, and the quality control standards the product will be 

18 required to meet 

19 (6) the proposed method of labeling or marking each unit, except timepieces or hands or 

20 dials containing tritium or promethium-147, and its container with the identification of 

21 the manufacturer or initial transferor of the product and the byproduct material in 

22 the product 

23 (7) for products for which limits on levels of radiation are specified in 10 CFR 30.15, the 

24 radiation level and the method of measurement 

25 In accordance with 10 CFR 32.14(b)(8), after receiving the application, the NRC may require the 

26 submittal of additional information, including experimental studies and tests, to facilitate a 

27 determination of the safety of the product. This would normally involve additional information 

28 provided after the NRC has reviewed the initial application and determined the need for 

29 additional studies or other information. 

30 Paragraph (c) of 10 CFR 32.14 requires that each product will contain no more than the quantity 

31 of byproduct material specified for that product in 10 CFR 30.15 and that the levels of radiation 

32 from each product will not exceed the limits specified for that product in 10 CFR 30.15. The 

33 details of the limits in the exemptions are included in Chapter 4, “Applicable Regulations.” 

34 Paragraph (d) of 10 CFR 32.14 requires the byproduct material to be properly contained in the 

35 product under the most severe conditions that are likely to be encountered in normal use 

36 and handling. 

37 10 CFR 32.14(d) requires the byproduct material to be properly contained in the product under 

38 the most severe conditions that are likely to be encountered in normal use and handling. Proper 

39 containment is demonstrated by prototype testing, as required by 10 CFR 32.14(b)(4). In the 
9-8 

1 case of products for which prototype testing is not required, this finding is based on the 

2 information submitted about the details of the product submitted under 10 CFR 32.14(b)(1), (2), 

3 and (3). Note that prototype testing is not required by 10 CFR 32.14 for electron tubes, 

4 ionization chamber smoke detectors, and timepieces containing promethium-147 or tritium in 

5 the form of gaseous tritium light sources. 

6 Conditions for any license issued under 10 CFR 32.14 appear in 10 CFR 32.15 and 

7 10 CFR 32.16. 

8 The information submitted under 10 CFR 32.14(b)(5) on quality control must demonstrate that 

9 the applicant/licensee will comply with the requirements of 

10  Paragraph (a) of 10 CFR 32.15, which requires each person licensed under 

11 10 CFR 32.14 to 

12 — Maintain quality assurance practices. 

13 — Subject inspection lots to acceptance sampling procedures. 

14 — Visually inspect each unit, except electron tubes containing byproduct material, in 

15 inspection lots. 

16  Paragraph (b) of 10 CFR 32.15, which states that no person licensed under 

17 10 CFR 32.14 shall transfer to other persons 

18 — any part or product tested and found defective; or 

19 — any part or product contained within any lot that has been sampled and rejected. 

20 The information submitted under 10 CFR 32.14(b)(6) on labeling must demonstrate that the 

21 applicant/licensee will comply with the requirements of 

22  Paragraph (d)(1) of 10 CFR 32.15, which requires licensees to label or mark each unit, 

23 so that the manufacturer or initial transferor of the product and the byproduct material in 

24 the product can be identified. 

25  Paragraph (d)(2) of 10 CFR 32.15, which requires licensees of ionization chamber 

26 smoke detectors to label or mark each detector and its point-of-sale package with more 

27 detailed information. 

28 The requirements for records and reporting are specified in 10 CFR 32.16. Information 

29 concerning the recordkeeping and reporting requirements are not required to be included in the 

30 application, because the requirements are fully specified in the regulations. However, the 

31 applicant needs to be aware of these responsibilities. Details concerning recordkeeping and 

32 annual reporting requirements can be found in Appendix B of this NUREG. 

33 Discussion: The information required by 10 CFR 32.14(b) provides the basis for determining 

34 whether the products described in 10 CFR 30.15(a) may be transferred to persons exempt from 

35 the requirements for a license set forth in Section 81, “Domestic Distribution,” of the Atomic 

36 Energy Act and from the regulations in 10 CFR Parts 20 and 30 through 36 and 39 to the extent 

37 that such person receives, possesses, uses, transfers, owns, or acquires those products. 
9-9 

1 Acceptable Prototype Procedures for Timepieces, Hands, and Dials Containing Tritium Paint; 

2 Static Eliminators and Ion-Generating Tubes; and Ionizing Radiation-Measuring Instruments 

3 Under 10 CFR 32.14(b)(4), prototype tests must be designed to show that the method of 

4 containment or binding of the byproduct material in the product is such that the radioactive 

5 material will not be released or be removed from the product under the most severe conditions 

6 likely to be encountered in normal use and handling. 

7 Applicants should provide information that verifies that their device will maintain its integrity 

8 during normal use and likely accident conditions. Normal use and likely accident conditions 

9 should include those experienced during installation, use, handling, maintenance, storage, and 

10 transportation (only normal conditions during transportation need to be considered). Applicants 

11 should determine an appropriate method to demonstrate the product’s ability to maintain its 

12 integrity when subjected to conditions of normal use and likely accident conditions. An applicant 

13 should describe the conditions of use for the product and likely accident scenarios. From that 

14 description, the applicant should test the device’s performance in likely accident temperatures, 

15 pressures, impacts, vibrations, and puncture tests. Following each of these tests, the applicant 

16 should evaluate the device for leakage or source dislodging from the source holder, if 

17 applicable. 

18 For timepieces containing tritium in the form of paint, applicants should determine and submit 

19 the appropriate methods of prototype testing to demonstrate and verify, for that type of product, 

20 that the method of containment or binding of the byproduct material in the product is such that 

21 the radioactive material will not be released or be removed from the product under the most 

22 severe conditions that the product is likely to encounter under everyday normal use and 

23 handling. Procedures for prototype testing of these products are contained in International 

24 Standard ISO 3157:1991(E), “Radioluminescence for time measurement instruments – 

25 Specifications” Second edition, November 15, 1991, International Organization for 

26 Standardization. Tritium will be considered to be properly bound to dials, hands, and pointers if 

27 there is no visible flaking or chipping and the total loss of tritium does not exceed 5 percent of 

28 the total tritium when prototype dials, hands, and pointers are subjected to appropriately 

29 designed prototype testing. 

30 In the case of dials, hands, and pointers with tritium paint, tritium has been considered to be 

31 properly bound to dials, hands, and pointers if there is no visible flaking or chipping and the total 

32 loss of tritium does not exceed 5 percent of the total tritium when prototype dials, hands, and 

33 pointers are subjected to the tests in ISO-3157. 

34 The exemption in 10 CFR 30.15(a)(9) is limited to instruments with internal calibration sources 

35 where the sources are not intended to be removed or changed by the user. In addition to any 

36 testing that may have been conducted on the sealed sources incorporated into the instrument, 

37 the instrument itself must undergo appropriately designed prototype testing to show that the 

38 source is unlikely to be damaged or dislodged from the instrument under the expected 

39 conditions of use. 

40 Acceptable Quality Control/Acceptance Sampling Procedures for Timepieces, Hands, and Dials 

41 Containing Tritium Paint and Ionizing Radiation-Measuring Instruments 

42 Regulations in 10 CFR 32.15 require acceptance sampling of those products used under 

43 10 CFR 30.15 (and equivalent Agreement State provisions) for which the NRC 

44 requires submittal of plans for quality control procedures. Such plans are required by 
9-10 

1 10 CFR 32.14(b)(5) for ionizing radiation-measuring instruments and timepieces containing 

2 tritium in the form of paint. Applicants must submit plans for quality control procedures to be 

3 followed in the fabrication of production lots of these products, as well as the quality control 

4 standards the product will be required to meet. The standard is 95 percent confidence that the 

5 lot tolerance percent defective of 5 percent will not be exceeded. Visual inspection of all units 

6 and rejection of any unit with an observable physical defect is also required. 

7 In acceptance sampling, a sample should be picked at random from the lot, and on the basis of 

8 information that was yielded by the sample, a decision should be made regarding the disposition 

9 of the lot. In general, the decision is either to accept or reject the lot. Actual tests or checks 

10 performed on the samples depend on the nature of the product. Aspects to be addressed for 

11 timepieces would include verifying the quantity of byproduct material and proper adherence of 

12 the paint to the hands and dials. For ionizing radiation measuring instruments, verifying the type 

13 and quantity of radioactivity would be even more important to performance than directly to 

14 safety. Quality checks for such instruments should include leak testing of sources and 

15 independent verification that sources are properly installed in the instruments. 

16 Acceptance sampling is the “middle-of-the-road” approach between no inspection and 

17 100 percent inspection. Acceptance sampling is employed when one or several of the following 

18 hold: 

19  Testing is destructive. 

20  The cost of 100 percent inspection is very high. 

21  100 percent inspection takes too long. 

22 Acceptance sampling depends on specific sampling plans, which when implemented indicate 

23 the conditions for acceptance or rejection of the immediate lot that is being inspected. 

24 Lot Tolerance Percent Defective: Lot Tolerance Percent Defective (LTPD) is defined in 

25 10 CFR 32.2, “Definitions,” as follows: 

26 “Lot Tolerance Percent Defective means, expressed in percent defective, the poorest quality in 

27 an individual inspection lot that should be accepted.” 

28 The regulations in 10 CFR 32.14(b)(5) require quality control procedures to be followed in the 

29 case of ionizing radiation-measuring instruments and timepieces containing tritium in the form of 

30 paint. For these products, the regulations in 10 CFR 32.15(a)(2) require persons licensed under 

31 10 CFR 32.14 to subject inspection lots to acceptance sampling procedures that provide at least 

32 95 percent confidence that the LTPD of 5.0 percent will not be exceeded. The specific 

33 procedures for accomplishing this are identified as a condition in the license. 

34 The LTPD of a sampling plan is a level of quality (e.g., percent defective, defects per hundred 

35 units) that the sampling plan will accept 5 percent of the time. This means lots at or worse than 

36 the LTPD are accepted at most 5 percent of the time. In other words, they are rejected at least 

37 95 percent of the time. 

38 Associated with the LTPD is a confidence statement the applicant can make. If the lot passes 

39 the sampling plan, the applicant can state with 95 percent confidence that the quality level (e.g., 

40 defective rate) is below the LTPD. In other words, passing the sampling plan demonstrates that 

41 the LTPD has been met. 
9-11 

1 Labeling 

2 For those products requiring labeling, the regulations state that the item distributed must display 

3 the required label, or if this is not possible, then the label should be placed on the product’s 

4 immediate container. For example, if an electron tube is too small to label, then the label should 

5 be placed on the next smallest container or its immediate container, such as the bubble pack 

6 containing the electron tube. 

7 Unique aspects of the exemption for items covered by 10 CFR 30.15 

8 Exemptions are provided by 10 CFR 30.15 for specific products and for specific radionuclides 

9 within each product type. In the case of 10 CFR 30.15(a)(9), “Ionizing radiation-measuring 

10 instruments for purposes of internal calibration or standardization,” radionuclides allowed are 

11 any listed in 10 CFR 30.71, “Schedule B,” with each source not to exceed the exempt quantity 

12 listed and each instrument not to exceed 10 times the Schedule B quantity. For these 

13 instruments, 0.05 microcurie of americium-241 is considered an exempt quantity. If more than 

14 one radionuclide is in an instrument, the sum of such fractions shall not exceed unity. That is, 

15 an individual exempt quantity may be composed of fractional parts of one or more of the exempt 

16 quantities in 10 CFR 30.71, provided that the sum of such fractions shall not exceed unity. 

17 This exemption is also unique with regard to quality control, in that the requirements on 

18 distribution of ionizing radiation monitoring instruments and timepieces containing tritium in the 

19 form of paint include some specific requirements for quality control spelled out in 10 CFR 

20 32.15(a). Products distributed in accordance with 10 CFR 32.22, 32.26, and 32.30 also require 

21 applicants to submit information about the applicant’s quality control procedures and standards, 

22 but do not include specific aspects as is stated in 10 CFR 32.15(a). 

23 Response from Applicant:

24 An applicant should provide sufficient information relating to the design, manufacture, labeling 

25 or marking, and in some cases, prototype testing, and proposed quality control procedures, to 

26 demonstrate that the products will meet any applicable quantity limits and radiation levels set 

27 forth in the regulations and that the byproduct material is properly contained in the product. 

28  Provide all of the information required as to the products the applicant intends to 

29 distribute. 

30  Provide information on quality control, if applicable, and information on product labeling. 

31 Checklist for Applications under 10 CFR 32.14 

Item 

No. Suggested Response 

Description 

Attached 

A Applicant satisfied general requirements in 30.33 [licensee provides 

copy of possession and use license] [ ] 

B Applicant provided sufficient information regarding product pertinent 

to evaluation of potential radiation exposure, including: [ ] 

1. Chemical and physical form and maximum quantity of byproduct 

material in each product [ ] 
9-12 

Item 

No. Suggested Response 

Description 

Attached 

2. Details of construction and design of product [ ] 

3. Method of containment or binding of byproduct material in product [ ] 

4. 

Procedures for prototype testing to demonstrate that the material will 

not become detached from the product or that byproduct material will 

not be released under severe conditions 

[ ] 

5. Results of prototype testing [ ] 

6. 

Quality control procedures to be followed in the fabrication and the 

quality control standards the product will be required to meet (10 CFR 

32.15) 

[ ] 

7. 

Proposed method of labeling or marking each unit, except for 

timepieces or hands or dials containing H 3 or Pm 147, and its 

container with the identification of the manufacturer or initial transferor 

and the byproduct material 

[ ] 

8. For products with limits specified in 10 CFR 30.15, the radiation level 

and method of measurement 

[ ] 

9. Any additional information, studies, and tests regarding product safety [ ] 

C 

The applicant assures that each product will contain no more than the 

quantity of byproduct material specified for that product in 10 CFR 

30.15. 

[ ] 

1. 

Product or material is not likely to be incorporated in any food; 

beverage; cosmetic; drug; or other commodity or product designed for 

ingestion or inhalation by, or application to, a human being. 

[ ] 

1 9.3 10 CFR 32.18: Exempt Quantities 

2 Regulations: 10 CFR 30.18, 10 CFR 30.71, 10 CFR 32.18; 10 CFR 32.19; 10 CFR 32.20 

3 Criteria: Applicants for a specific license to manufacture, process, produce, package, 

4 repackage, or transfer quantities of byproduct material for commercial distribution to persons 

5 exempt from the requirements for a license under 10 CFR 30.18 or the equivalent regulations of 

6 an Agreement State apply under 10 CFR 32.18. 

7 Applicants must obtain a specific license under 10 CFR 32.18 in order to commercially distribute 

8 byproduct material in exempt quantities, even if the material was obtained from another 

9 commercial distributor licensed under 10 CFR 32.18. An SSD review and issuance of a 

10 certificate of registration are not required for these materials, even if in the form of 

11 sealed sources. 

12 Example products: 

13  encapsulated or check sources—in quantities not exceeding 10 CFR 30.71, 

14 “Schedule B:” 10 microcuries cesium-137 

15  calibration or counting standards—(e.g., in quantities not exceeding 10 CFR 30.71: 

16 100 microcuries carbon-14)
9-13 

1 Paragraph (a) of 10 CFR 32.18 indicates that the applicant must satisfy the general 

2 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

3 information concerning possession license requirements. 

4 Paragraph (b) of 10 CFR 32.18 indicates that the byproduct material is not to be contained in 

5 any food; beverage; cosmetic; drug; or other commodity designed for ingestion or inhalation by, 

6 or application to, a human being. 

7 Paragraph (c) of 10 CFR 32.18 indicates that the byproduct material is to be in the form of 

8 processed chemical elements, compounds, or mixtures; tissue samples; bioassay samples; 

9 counting standards; plated or encapsulated sources, or similar substances, identified as 

10 radioactive and to be used for its radioactive properties, but is not to be incorporated into any 

11 manufactured or assembled commodity, product, or device intended for commercial distribution. 

12 Conditions for any license issued under 10 CFR 32.18 appear in 10 CFR 32.19. Under 

13 10 CFR 32.18(d), the applicant must provide copies of prototype labels and brochures for NRC 

14 approval. The prototype labels and brochures and any additional information about labeling and 

15 brochures provided under 10 CFR 32.18(d) will form the basis for meeting the requirements of 

16 10 CFR 32.19(c) and (d) and must be consistent with those requirements. 

17 The requirements for records and reporting are specified in 10 CFR 32.20. Information 

18 concerning the recordkeeping and reporting requirements are not required to be included in the 

19 application, because the requirements are fully specified in the regulations. However, the 

20 applicant needs to be aware of these responsibilities. Details concerning recordkeeping and 

21 annual reporting requirements can be found in Appendix B of this NUREG. 

22 Discussion: When the transfer of byproduct material in individual quantities not exceeding the 

23 limits set in 10 CFR 30.71 occurs for commercial benefit, then paragraphs 10 CFR 30.18(c) and 

24 (d) apply, and the manufacture, processing, production, packaging, repackaging, or transfer for 

25 distribution to persons exempt from licensing requirements must be specifically licensed. 

26 Therefore, each person engaging in the commercial transfer or distribution of exempt quantity 

27 products must have a license authorizing commercial distribution under 10 CFR 32.18. The 

28 commercial transfer of a product refers to the introduction of a material into the marketplace, 

29 whether or not a charge is assessed for that distribution. Commercial benefit does not 

30 necessarily include a monetary exchange. 

31 Information on the Product(s)

32 The application should identify the byproduct material to be used and the type(s) 

33 (e.g., disc check sources, rod sources, scintillation counting standards) of products intended for 

34 distribution and provide a drawing (or picture) of the product type(s). The drawing should 

35 indicate the location of the required label. 

36 Applicants should request authorization only for the isotopes that are of interest. When 

37 appropriate, it is acceptable to reference the byproduct material as: all isotopes not to exceed 

38 the activities listed in 10 CFR 30.71. 

39 The application should clearly state the form, chemical and physical, of the byproduct material 

40 to be distributed. It should demonstrate that the byproduct material will be distributed in 

41 compliance with the constraints in 10 CFR 32.18(b) and (c); for example, it should confirm that 

42 the material’s intended use is for its radioactive properties and that it is not to be incorporated 
9-14 

1 into any manufactured or assembled commodity, product, or device intended for commercial 

2 distribution. 

3 Limitation on Packaging 

4 The constraints on the shipment of exempt quantities under 10 CFR 32.19(a) indicate, in part, 

5 that “no more than 10 exempt quantities ... shall be sold or transferred in any single 

6 transaction,” and under 10 CFR 32.19(b), “. . . no more than 10 such packaged exempt 

7 quantities shall be contained in any outer package for transfer to persons exempt . . .” 

8 The regulation allows any number of items to be transferred in a single transaction, provided 

9 that the amount of byproduct material contained in the transfer does not exceed 10 times the 

10 specified exempt quantity in 10 CFR 30.71. 

11 For example, assume that an individual is shipping packages of individual check sources, each 

12 containing 1/10 of the exempt quantity limit. He or she packages each of these check sources 

13 individually. That person may then take 100 of these packages and ship them in one 

14 transaction, because this constitutes 10 times the exempt quantity in one transaction. 

15 Acceptable Labeling

16 As specified in 10 CFR 32.19(c), the immediate container of each quantity or separately 

17 packaged fractional quantity of byproduct material shall bear a durable, legible label that 

18 (1) identifies the radioisotope and the quantity of radioactivity, and (2) bears the words 

19 “Radioactive Material.” The submission of “generic” labels (Figure 9-1) with a statement 

20 indicating that the required information will be contained on the label will be acceptable, 

21 provided the required information remains as submitted and meets the necessary requirements. 

22 For example, the licensee may state that the label on the check sources will contain, at least, 

23 the following: the words “Radioactive Material,” Radioisotope: XXXX, and Activity: XXX 

24 microcuries. In the case of sealed sources, the immediate container is normally the 

25 encapsulation material. 

62-pt4-4029-ed03b.ppt

071398

Radioactive Material

Radioisotope:

Activity:

Figure 9-1. Example of Exempt Quantities: Labeling

26 Paragraph (d) of 10 CFR 32.19 requires that either the label affixed to the immediate container, 

27 or an accompanying brochure, shall also: (1) state that the contents are exempt from NRC or 

28 Agreement State licensing requirements; (2) bear the words “Radioactive Material—Not for 
9-15 

1 Human Use—Introduction Into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or Into 

2 Products Manufactured for Commercial Distribution is Prohibited—Exempt Quantities Should 

3 Not be Combined;” and (3) contain additional basic radiation safety and good laboratory 

4 practices and instructions pertaining to the proper handling, use, storage, and disposal of the 

5 radioactive material. (Examples of the type of information that should be addressed are given 

6 below.) The information included in the product brochure should be appropriate to the product 

7 and its use. 

8 Products authorized for exempt distribution are generally received by unlicensed persons. 

9 Therefore, the information provided to the licensee’s customers should not imply regulatory 

10 restrictions. For example, statements in the product brochures that the products must be 

11 disposed of in a certain manner or returned to the licensee are inappropriate and should not be 

12 contained in the information provided to the licensee’s customers, except for those customers 

13 that are licensed. If the customer receiving the exempt quantity is a specific licensee, then the 

14 customer is subject to the requirements of 10 CFR Part 20 (e.g., waste disposal). 

15 Example Instructions for Safe Handling, Use, Storage, and Disposal of Radioactive 

16 Material 

17 1. Handling 

18  Basic radiation principles of time, distance, and shielding should be practiced so 

19 as to minimize radiation exposure (i.e., minimizing the time spent around 

20 radioactive material, as well as maximizing the distance and the shielding 

21 between persons and the radioactive material). 

22  Use of radioactive material should be restricted to authorized, responsible 

23 persons in authorized areas. 

24  Activities such as eating, drinking, smoking, or the application of cosmetics 

25 should be prohibited in areas of use. 

26  Gloves and laboratory coats should be worn when working with liquid 

27 radioactive material. 

28 2. Use 

29  Exempt quantity products containing radioactive material should be used only in 

30 accordance with these instructions. 

31 3. Storage 

32  All radioactive materials should be securely stored when not in use. 

33 4. Disposal 

34  Radioactive materials in exempt quantities can be disposed of in regular waste 

35 without regard to their radioactive content (unless the person is specifically 

36 licensed). 
9-16 

1  Liquid materials disposed in laboratory sinks should be flushed with copious 

2 amounts of water. 

3  Specific licensees (such as laboratory/academic institutions) receiving exempt 

4 quantities are subject to the requirements of 10 CFR Part 20, in particular, waste 

5 disposal requirements. 

6 Unique aspects of the exemption for exempt quantities 

7 The exemption from licensing requirements in 10 CFR 30.18 does not include an exemption 

8 from 10 CFR Parts 19 and 20. These parts, however, do not apply to unlicensed persons. 

9 Thus, the effect of this is that specific licensees are not exempt from these parts even with 

10 respect to materials covered under this exemption. In practice, the significance of this is that 

11 disposal of these materials come under the requirements of 10 CFR Part 20. This is in order to 

12 prevent specific licensees from using this provision to dispose of licensed materials improperly. 

13 General licensees are separately exempted from all or most of 10 CFR Parts 19 and 20 in 

14 accordance with each particular general license. 

15 The requirement for a distribution license for exempt quantities applies to all commercial 

16 distribution, rather than only to initial distribution; thus, secondary commercial distributors also 

17 need to be licensed under 10 CFR 32.18. Noncommercial transfers are allowed without a 

18 license, even if “initial.” 

19 There is no requirement for the applicant to submit and for the NRC to review any quality control 

20 procedures. However, the applicant should establish means to ensure that it complies with the 

21 license conditions required by 10 CFR 32.19. 

22 Response from Applicant: 

23 An applicant should provide sufficient information relating to the manufacture, labeling or 

24 marking, brochures, and packaging procedures to demonstrate that the products will meet the 

25 restrictions set forth in the regulations. 

26  Provide all of the information requested for the product to be distributed. 

27  Provide information on product labeling and the content of brochures, including 

28 information on the safety instructions that will be provided to recipients. Provide copies 

29 of prototypes or actual labels. 

30 Checklist for Applications under 10 CFR 32.18 

Item 

No. Suggested Response 

Description

Attached 

A Applicant satisfied general requirements in 30.33 [licensee provides 

copy of possession and use license]. 

[ ] 

B Applicant confirmed that the byproduct material is not to be contained in 

any food; beverage; cosmetic; drug; or other commodity designed for 

ingestion or inhalation by, or application to, a human being. 

[ ] 
9-17 

Item 

No. Suggested Response 

Description

Attached 

C Applicant confirmed that the byproduct material is to be in the form of 

processed chemical elements, compounds, or mixtures, tissue samples, 

bioassay samples, counting standards, plated or encapsulated sources, 

or similar substances, identified as radioactive and to be used for its 

radioactive properties, but will not be incorporated into any 

manufactured or assembled commodity, product, or device intended for 

commercial distribution. 

[ ] 

D Applicant provided evidence that each source will contain no more than 

the applicable quantity limits for each exempt quantity and that each 

transfer will not exceed the applicable quantity limits for single transfers. 

[ ] 

E Applicant provided evidence that materials will be packaged in 

compliance with the regulations, including the external dose rate limit in 

10 CFR 32.19(b). 

[ ] 

F Applicant supplied acceptable prototype labels and brochures. [ ] 

1 9.4 10 CFR 32.21: Radioactive Drug: Capsules Containing Carbon-14 

2 Urea for “In Vivo” Diagnostic Use for Humans 

3 Regulations: 10 CFR 30.21, 10 CFR 32.21, 10 CFR 32.21a, 10 CFR 32.72(a)(2) 

4 Criteria: Applicants for a specific license to manufacture, prepare, process, produce, package, 

5 repackage, or transfer for commercial distribution capsules containing 37 kBq [1 μCi] of 

6 carbon-14 urea each for “in vivo” diagnostic use for humans under 10 CFR 30.21 or the 

7 equivalent regulations of an Agreement State apply under 10 CFR 32.21. 

8 Applicants must obtain a specific license under 10 CFR 32.21 in order to commercially distribute 

9 these capsules for use under the exemption in 10 CFR 30.21. A Sealed Source and Device 

10 (SSD) review and issuance of a certificate of registration are not required for these products. 

11 Paragraph (a) of 10 CFR 32.21 indicates that the applicant must satisfy the general 

12 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

13 information concerning possession license requirements. 

14 Paragraph (a)(2) of 10 CFR 32.21 requires that the applicant meets the requirements in 

15 10 CFR 32.72(a)(2). Thus, applications must contain evidence confirming that the applicant is 

16 either registered or licensed with the U.S. Food and Drug Administration, or with a State agency 

17 as a drug manufacturer, or as a Positron Emission Tomography (PET) drug production facility, 

18 or licensed as a pharmacy by a State Board of Pharmacy, or operating as a nuclear 

19 pharmacy within a Federal medical institution. Paragraph (a)(3) of 10 CFR 32.21 requires 

20 that the applicant provides evidence that each capsule contains 37 kilobecquerel (kBq) 

21 [1 microcurie (μCi)] carbon-14 urea (allowing for nominal variation that may occur during the 

22 manufacturing process). 

23 10 CFR 32.21(a)(4) requires that the carbon-14 urea is not to be contained in any food; 

24 beverage; cosmetic; drug (except as described in 10 CFR 32.21); or other commodity designed 

25 for ingestion or inhalation by, or topical application to, a human being. 10 CFR 32.21(a)(5) 

26 requires that carbon-14 urea is to be in the form of a capsule, identified as radioactive, and to be 
9-18 

1 used for its radioactive properties, but is not incorporated into any manufactured or assembled 

2 commodity, product, or device intended for commercial distribution. 

3 Paragraph (a)(6) of 10 CFR 32.21 requires that the applicant submits copies of prototype labels 

4 (Figure 9-2) and brochures for NRC approval. 

5 Conditions for any license issued under 10 CFR 32.21 appear in 10 CFR 32.21a and concern 

6 labeling of the capsule and its immediate container (or accompanying brochure). 

7 The information on labeling submitted under 10 CFR 32.21(a)(6) will form the basis for meeting 

8 the requirements of 10 CFR 32.21a and must be consistent with those requirements. 

9 Discussion: The use of carbon-14 urea capsules for research involving human subjects is 

10 prohibited under this exemption and requires that a specific license be issued under 10 CFR 

11 Part 35, “Medical Use of Byproduct Material,” for that purpose. Also, the exemption does not 

12 relieve persons from complying with applicable U.S. Food and Drug Administration (FDA) or 

13 other Federal and State requirements governing receipt, administration, and use of drugs. 

14 Acceptable Labeling 

15 The following figure illustrates the method of labeling for products under 10 CFR 32.21. 

62-pt4-4029-ed04a.ppt

050798

Radioactive Material

Radioisotope:

Activity:

Radioactive Material

Radioisotope:

Activity:

Figure 9-2. Example of Acceptable Radioactive Drug Labeling. 

16 Unique aspects of the exemption for carbon-14 urea capsules for “in vivo” diagnostic use for 

17 humans in 10 CFR 30.21 

18 Applicants must be qualified to obtain a license under 10 CFR 32.21 by being licensed or 

19 registered in one of the ways specified in 10 CFR 32.72(a)(2) to manufacture drugs. 

20 Licensees under 10 CFR 32.21 are not required to submit annual summary transfer reports to 

21 the NRC. 

22 Response from Applicant: 

23 An applicant must: 

24  Provide evidence confirming that it meets the requirements in 10 CFR 32.72(a)(2). 

25  Provide the information required as to the capsules it intends to distribute. 

26  Provide information on labeling and brochures, including prototype labels and brochures. 

27 
9-19 

1 Checklist for Applications under 10 CFR 32.21 

Item 

No. Suggested Response 

Description

Attached 

A Applicant satisfied general requirements in 30.33 [licensee provides 

copy of possession and use license]. [ ] 

B Applicant provided evidence of meeting 10 CFR 32.72(a)(2). [ ] 

C 

Applicant provided evidence that each capsule will contain 37 kBq (1 

μCi) carbon 14 urea (allowing for nominal variation that may occur 

during the manufacturing process). 

[ ] 

D 

Applicant confirmed that the capsules will not be contained in any food; 

beverage; cosmetic; drug (except as described in 10 CFR 32.21); or 

other commodity designed for ingestion or inhalation by, or topical 

application to, a human being; the carbon 14 urea will be in the form of 

a capsule, identified as radioactive, and to be used for its radioactive 

properties, but will not be incorporated into any manufactured or 

assembled commodity, product, or device intended for commercial 

distribution. 

[ ] 

E Applicant supplied acceptable prototype labels and brochures. [ ] 

2 9.5 10 CFR 32.22: Self-Luminous Products Containing Tritium, 

3 Krypton-85, or Promethium-147 

4 Regulations: 10 CFR 30.19, 10 CFR 32.22, 10 CFR 32.23, 10 CFR 32.24, 10 CFR 32.25, 

5 10 CFR 32.210 

6 Criteria: Applicants for a specific license to manufacture, process, produce, or initially transfer 

7 for sale or distribution self-luminous products containing tritium, krypton-85, or promethium-147 

8 to any person exempt from the requirements for a license under 10 CFR 30.19 or equivalent 

9 regulations of an Agreement State apply under 10 CFR 32.22. The exemption in 10 CFR 30.19 

10 does not apply to products primarily for frivolous purposes or in toys or adornments. 
9-20 

Figure 9-3. Example of Self-Luminous Products: Front and Rear Gun Sights

1 You must obtain a specific license under 10 CFR 32.22 and a registration certificate under 

2 10 CFR 32.210 to distribute self-luminous products for use under the exemption in 

3 10 CFR 30.19. 

4 Example products 

5  Chemical agent detectors 

6  Explosives detectors 

7 Paragraph (a)(1) of 10 CFR 32.22 indicates that the applicant must satisfy the general 

8 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

9 information concerning possession license requirements. 

10 The applicant should provide the following information about the product, as outlined in 

11 10 CFR 32.22(a)(2): 

12 Sufficient information relating to the design; manufacture; prototype testing; quality control 

13 procedures; labeling or marking; and conditions of handling, storage, use, and disposal of the 

14 self-luminous product to demonstrate that the product will meet the safety criteria set forth in 

15 10 CFR 32.23. The information must include: 

16  a description of the product and its intended use or uses 

17  the type and quantity of byproduct material in each unit 

18  chemical and physical form of the byproduct material in the product and changes in 

19 chemical and physical form that may occur during the useful life of the product 

20  solubility in water and body fluids of the identified forms of byproduct material, including 

21 any forms that arose as a result of prototype testing 

ed05.ppt

071798
9-21 

1  details of construction and design of the product as related to containment and shielding 

2 of the byproduct material and other safety features under normal and severe conditions 

3 of handling, storage, use, and disposal of the product 

4  maximum external radiation levels at 5 and 25 centimeters from any external surface of 

5 the product, averaged over an area not to exceed 10 square centimeters, and the 

6 method of measurement 

7  degree of access of human beings to the product during normal handling and use 

8  total quantity of byproduct material expected to be distributed in the product annually 

9  the expected useful life of the product 

10  the proposed method of labeling or marking each unit with identification of the 

11 manufacturer or initial transferor of the product and the byproduct material in the product 

12  procedures for prototype testing of the product to demonstrate the effectiveness of the 

13 containment, shielding, and other safety features under both normal and severe 

14 conditions of handling, storage, use, and disposal of the product 

15  results of the prototype testing of the product, including any change in the form of the 

16 byproduct material contained in the product, the extent to which the byproduct material 

17 may be released to the environment, any increase in external radiation levels, and any 

18 other changes in safety features 

19  the estimated external radiation doses and dose commitments relevant to the safety 

20 criteria in 10 CFR 32.23 and the basis for such estimates 

21  a determination that the probabilities with respect to the doses referred to in 

22 10 CFR 32.23(d) meet the criteria of that paragraph 

23  quality control procedures to be followed in the fabrication of production lots of the 

24 product and the quality control standards the product will be required to meet 

25  any additional information, including experimental studies and tests, required by 

26 the NRC 

27 The dose assessment submitted under 10 CFR 32.22(a)(2)(xiii) to demonstrate that the device 

28 meets the safety criteria in 10 CFR 32.23 must be consistent with all of the other information 

29 submitted about the device under 10 CFR 32.22(a)(2). 

30 Paragraph (c) of 10 CFR 32.210 also requires certain information to be submitted as a basis for 

31 registering the device. Generally, the requirements of 10 CFR 32.22 cover the same categories 

32 of information in a more detailed manner, but it is not a complete substitute for meeting the 

33 requirements of 10 CFR 32.210(c). Paragraph (d) of 10 CFR 32.210 refers to Subpart A of 

34 10 CFR Part 32 for the additional criteria for certain exempt products. Thus, the criteria in 

35 10 CFR 32.22 and 32.23 discussed here are also considered in the registration process. 
9-22 

1 Conditions for any license issued under 10 CFR 32.22 appear in 10 CFR 32.25. In addition to 

2 providing the basis for demonstrating that a device meets the safety criteria of 10 CFR 32.23, 

3 there are other purposes for the information required to be submitted under 10 CFR 32.22: 

4  The information on quality control procedures submitted under 10 CFR 32.22(a)(2)(xv) 

5 will supply the basis for meeting the requirements of 10 CFR 32.25(a). 

6  The information on labeling submitted under 10 CFR 32.22(a)(2)(x) will form the basis 

7 for meeting the requirements of 10 CFR 32.25(b) and must be consistent with that 

8 requirement. 

9 Paragraph (c) of 10 CFR 32.25 specifies the requirements for records and reporting. 

10 Information concerning the recordkeeping and reporting requirements are not required to be 

11 included in the application, because the requirements are fully specified in the regulations. 

12 However, the applicant needs to be aware of these responsibilities. Details concerning 

13 recordkeeping and annual reporting requirements can be found in Appendix B of this NUREG. 

14 The certificate holder is also subject to 10 CFR 32.210(f), which requires that the product be 

15 manufactured and distributed in accordance with the statements and representations made by 

16 the applicant and the provisions of the registration certificate. 

17 Discussion: Applicants should list all models of each type of product/device they wish to 

18 distribute. Applicants may request to have models listed as a series and may sometimes have 

19 multiple models or series registered on the same registration certificate. In order to have 

20 models listed as a series, they should be essentially the same in design features affecting safety 

21 but may be different in other respects, such as cosmetic differences. 

22 Applicants should provide detailed engineering drawings of each model in each series with a list 

23 of the differences between the models in each series and for the models or series proposed to 

24 be registered on the same certificate. The drawings should clearly show all dimensions and 

25 tolerances, describe or identify the various construction materials, and provide the details of the 

26 source mounting configuration(s) to be used in each model or series. This information must be 

27 provided for each type of material used, such as steel, aluminum, or plastic. 

28 Models or series on the same certificate would be differentiated by such differences as size, 

29 construction, radionuclide, and source activity. For example, the Series 100 is a “2-Dot” sight, 

30 the basic Series 200 is a “2-Bar” sight, and the Series 300 has a larger source activity per tritium 

31 source than either the 100 or 200 series. 

32 Products/devices will be identified by model number. A typical model-numbering system would 

33 use a different numerical designation for models or series where there are some differences of 

34 radiological significance, such as source activity, and models within a series would show an 

35 additional letter designation to distinguish models with cosmetic differences or other aspects 

36 unrelated to safety. 

Appendix D of this NUREG, “Additional Guidance for Self-Luminous Products,” provides 

examples of information to be submitted that may be of use in preparing a license and 

registration application, and includes an acceptable prototype test procedure and an example 

dose assessment for gun sights. 
9-23 

1 Applicants should submit a sample or drawing of the typical or generic label showing how the 

2 requirements of 10 CFR 32.25(b) will be met. 

3 Note: The NRC’s policy on labeling is that the smallest item distributed must contain the 

4 required label. If this is not possible, then the label should be placed as close as possible to the 

5 product. 

6 In developing scenarios for the dose assessment, the distributor should be able to make 

7 reasonable assumptions about the industries or market segment(s) that they expect to serve 

8 with their product(s) and how the product(s) will be used. The reviewer needs to determine if 

9 the assumptions presented are indeed reasonable. This determination becomes particularly 

10 important if the projected doses are approaching an applicable limit. 

11 Additional discussion about the dose assessment needed to demonstrate that a product meets 

12 applicable safety criteria is provided in Appendix E of this NUREG. 

13 Unique aspects of the class exemption for self-luminous products (10 CFR 30.19) 

14 The purpose of a self-luminous product is simply to produce light. Beyond that, self-luminous 

15 products can be used for a multitude of purposes, some of which would present minimal benefit 

16 to society. Because of this, there is a specific restriction in the exemption, paragraph (c), that 

17 states that the exemption does not apply to tritium, krypton-85, or promethium-147 used in 

18 products primarily for frivolous purposes or in toys or adornments. This exclusion is considered 

19 when reviewing a license application submitted under 10 CFR 32.22. 

20 Also, a product can be a “self-luminous product” and not necessarily be incorporated into a 

21 specific product with clearly foreseeable uses. So, in addition, 10 CFR 32.22(b) indicates that 

22 the NRC may deny an application for a specific license under this section if the end uses of the 

23 product cannot be reasonably foreseen. This is to prevent the wide distribution of self-luminous 

24 products in a variety of uses for which the conditions of use and the dose impacts cannot be 

25 adequately evaluated when initially approving the product and also so that the NRC may ensure 

26 that the uses of the products under exemption are justified. When there is any question about 

27 the acceptability of the product for use under exemption, the applicant should refer to the 

28 Consumer Product Policy Statement (79 FR 2907, January 16, 2014). 

29 Response from Applicant: 

30 An applicant must provide sufficient information relating to the design, manufacture, prototype 

31 testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, 

32 and disposal of the self-luminous products to demonstrate that the product will meet the safety 

33 criteria set forth in the regulations. The applicant must provide all of the information required as 

34 to the products it intends to distribute, including: 

35  Provide an adequate dose assessment addressing all of the appropriate scenarios to 

36 demonstrate that the device meets the safety criteria in 10 CFR 32.23, which references 

37 the table in 10 CFR 32.24. 

38  Provide information on quality control and information on product labeling. (Actual 

39 example labels are helpful.) 
9-24 

1  Submit information on the safety instructions that will be provided to recipients [required 

2 by 10 CFR 32.210(c)]. 

3 Additional guidance pertaining to obtaining the registration certificate under 10 CFR 32.210 is 

4 provided in NUREG-1556, Volume 3, “Applications for Sealed Source and Device Evaluation 

5 and Registration.” 

6 Checklist for Applications under 10 CFR 32.22 

Item 

No. Suggested Response 

Description

Attached 

A Applicant satisfied general requirements in 30.33 [licensee provides 

copy of possession and use license]. 

[ ] 

B Applicant submitted sufficient information regarding product pertinent to 

evaluation of potential radiation exposure, to demonstrate that the 

product will meet the safety criteria set forth in 10 CFR 32.23, including: 

[ ] 

1. Description of the product and its intended use or uses (conforms to 

class and expected uses are clearly foreseeable) 

[ ] 

2. Type and quantity of byproduct material in each unit [ ] 

3. Chemical and physical form of the byproduct material in the product and 

changes in chemical and physical form that may occur during the useful 

life of the product 

[ ] 

4. Solubility in water and body fluids of the forms of the identified 

byproduct material 

[ ] 

5. Details of construction and design of the product as related to 

containment and shielding of the byproduct material and other safety 

features under normal and severe conditions of handling, storage, use, 

and disposal of the product 

[ ] 

6. Maximum external radiation levels at 5 and 25 centimeters from any 

external surface of the product, averaged over an area not to exceed 10 

square centimeters, and the method of measurement 

[ ] 

7. Degree of access of human beings to the product during normal 

handling and use 

[ ] 

8. Total quantity of byproduct material expected to be distributed in the 

products annually 

[ ] 

9. Expected useful life of the product [ ] 

10. Methods of labeling or marking the product and its point of sale 

packaging 

[ ] 

11. Procedures for and results of prototype testing of the product [ ] 

12. The estimated external radiation doses and dose commitment resulting 

from the intake of byproduct material in any one year relevant to the 

safety criteria in 10 CFR 32.23 and the basis for these estimates [Use 

table in Appendix E] 

[ ] 

13. A determination that the probabilities with respect to the doses referred 

to in 10 CFR 32.23(d) meet the criteria of that paragraph 

[ ] 

14. Quality control procedures to be followed in the fabrication of production 

lots of the products and the quality control standards the products will 

[ ] 
9-25 

Item 

No. Suggested Response 

Description

Attached 

be required to meet 

15. Any additional information, including experimental studies and tests, if 

required by the NRC 

[ ] 

C Containment, shielding, and other safety features are not likely to be 

significantly impacted by likely wear and abuse during normal handling 

and use. 

[ ] 

D Specific scenarios analyzed in dose assessment [Use table in 

Appendix E]. 

[ ] 

1 9.6 10 CFR 32.26: Gas and Aerosol Detectors Containing Byproduct 

2 Material 

3 Regulations: 10 CFR 30.20, 10 CFR 32.26, 10 CFR 32.27, 10 CFR 32.28, 10 CFR 32.29, 

4 10 CFR 32.210 

5 Criteria: An application for a specific license to manufacture, process, or produce gas and 

6 aerosol detectors containing byproduct material and designed to protect health, safety, or 

7 property, or to initially transfer such products for use under 10 CFR 30.20 or equivalent 

8 regulations of an Agreement State apply under 10 CFR 32.26. 

Figure 9-4. Smoke Detectors. Smoke Detectors are One Type of Product Distributed to 

Persons Exempt From Licensing Under 10 CFR 30.20; Certain Ones May 

Also be Distributed for Use Under 10 CFR 30.15(a)(7). 

9 You must obtain a specific license under 10 CFR 32.26 and registration certificate under 

10 10 CFR 32.210 in order to distribute such gas and aerosol detectors for use under the 

11 exemption in 10 CFR 30.20. 

12 Paragraph (a) of 10 CFR 32.26 indicates that the applicant must satisfy the general 

13 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

14 information concerning possession license requirements. 
9-26 

1 Paragraph (b) of 10 CFR 32.26 requires the submission of sufficient information relating to the 

2 design, manufacture, prototype testing, quality control procedures, labeling or marking, and 

3 conditions of handling, storage, use, and disposal of the gas and aerosol detector to 

4 demonstrate that the product will meet the safety criteria set forth in 10 CFR 32.27. The 

5 information must include: 

6  a description of the product and its intended use or uses 

7  the type and quantity of byproduct material in each unit 

8  chemical and physical form of the byproduct material in the product and changes in 

9 chemical and physical form that may occur during the useful life of the product 

10  solubility in water and body fluids of the identified forms of the byproduct material, 

11 including any forms that arose as a result of prototype testing 

12  details of construction and design of the product as related to containment and shielding 

13 of the byproduct material and other safety features under normal and severe conditions 

14 of handling, storage, use, and disposal of the product 

15  maximum external radiation levels at 5 and 25 centimeters from any external surface of 

16 the product, averaged over an area not to exceed 10 square centimeters, and the 

17 method of measurement 

18  degree of access of human beings to the product during normal handling and use 

19  total quantity of byproduct material expected to be distributed in the product annually 

20  the expected useful life of the product 

21  the proposed methods of labeling or marking the detector and its point-of-sale package 

22 to satisfy the requirements of 10 CFR 32.29(b) 

23  procedures for prototype testing of the product to demonstrate the effectiveness of the 

24 containment, shielding, and other safety features under both normal and severe 

25 conditions of handling, storage, use, and disposal of the product 

26  results of the prototype testing of the product, including any change in the form of the 

27 byproduct material contained in the product, the extent to which the byproduct material 

28 may be released to the environment, any increase in external radiation levels, and any 

29 other changes in safety features 

30  the estimated external radiation doses and dose commitments relevant to the safety 

31 criteria in 10 CFR 32.27 and the basis for such estimates; 

32  a determination that the probabilities with respect to the doses referred to in 10 CFR 

33 32.27(c) meet the criteria of that paragraph 

34  quality control procedures to be followed in the fabrication of production lots of the 

35 product and the quality control standards the product will be required to meet; in 
9-27 

1 accordance with 32.26(b)(16), the applicant must also supply any additional information, 

2 including experimental studies and tests, if required by the NRC 

3 The dose assessment submitted under 10 CFR 32.26(b)(13) to demonstrate that the device 

4 meets the safety criteria in 10 CFR 32.27 must be consistent with all of the other information 

5 submitted about the device under 10 CFR 32.26(b). 

6 Paragraph (c) of 10 CFR 32.210 also requires certain information to be submitted as a basis for 

7 registering the device. Generally, the requirements of 10 CFR 32.26 cover the same categories 

8 of information in a more detailed manner but is not a complete substitute for meeting the 

9 requirements of 10 CFR 32.210(c). Paragraph (d) of 10 CFR 32.210 refers to Subpart A of 

10 10 CFR Part 32 for the additional criteria for certain exempt products. Thus, the criteria in 

11 10 CFR 32.26 and 32.27 discussed here are also considered in the registration process. 

12 Conditions for any license issued under 10 CFR 32.26 appear in 10 CFR 32.29. 

13 In addition to providing the basis for demonstrating that a device meets the safety criteria of 

14 10 CFR 32.27, there are other purposes for the information required to be submitted under 

15 10 CFR 32.26: 

16  The information on quality control procedures submitted under 10 CFR 32.26(b)(15) will 

17 supply the basis for meeting the requirements of 10 CFR 32.29(a). 

18  The information on labeling submitted under 10 CFR 32.26(b)(10) will form the basis for 

19 meeting the requirements of 10 CFR 32.29(b) and must be consistent with that 

20 requirement. 

21 Paragraph (c) of 10 CFR 32.29 specifies the requirements for records and reporting. 

22 Information concerning the recordkeeping and reporting requirements are not required to be 

23 included in the application, because the requirements are fully specified in the regulations. 

24 However, the applicant needs to be aware of these responsibilities. Details concerning 

25 recordkeeping and annual reporting requirements can be found in Appendix B. 

26 The certificate holder is also subject to 10 CFR 32.210(f), which requires that the product be 

27 manufactured and distributed in accordance with the statements and representations made by 

28 the applicant and the provisions of the registration certificate. 

29 Discussion: The applicant must provide clear and detailed information to show that the gas or 

30 aerosol detector is designed to protect health, safety, or property. Existing examples include 

31 certain smoke detectors, hazardous or explosive dust detectors, and toxic gas detectors. 

32 Applicants should note that distribution of ionization chamber smoke detectors containing not 

33 more than 1 microcurie (μCi) of americium-241 per detector in the form of a foil and designed to 

34 protect life and property from fires may be licensed under 10 CFR 32.14; the exemption for 

35 these smoke detectors is established in 10 CFR 30.15(a)(7). 

36 Applicants should list all models of each type of product they wish to distribute. As discussed in 

37 Section 9.5, applicants may request to have models listed as a series, or multiple models or 

38 series on a single registration certificate. In order to have models listed as a series, the models 

39 should be essentially the same with respect to factors affecting radiological safety. In order to 

40 have models or series of models listed on the same certificate, there should be similarities in the 

41 design and construction of the devices. 
9-28 

1 Applicants should provide detailed engineering drawings of each basic model in each series 

2 with a list of the differences between the models in each series and for the models or series 

3 proposed to be registered on the same certificate. The drawings should clearly show all 

4 dimensions and tolerances, describe or identify the construction materials, and provide the 

5 details of the source mounting. This information must be provided for each type of material 

6 used, such as steel, aluminum, or plastic. 

7 Models or series on the same certificate would be differentiated by such differences as size, 

8 construction, radionuclide, and source activity. For example, the Series 200 is larger in size 

9 than the basic Series 100, and the Series 300 has a larger source activity than either the 

10 100 or 200. 

11 Models contained within each series are the same basic model, with cosmetic differences such 

12 as lights and timers. For example, a basic model designated as the Series 100 could be 

13 registered to include the 100A model with a 3-second timer, and the 100B with a 5-second 

14 timer. 

15 Applicants should submit a sample or drawing of the typical or generic label and point-of-sale 

16 package showing how the requirements of 10 CFR 32.29(b) will be met. 

17 In developing scenarios for the dose assessment, the distributor should be able to make 

18 reasonable assumptions about the industries or market segment(s) that they expect to serve 

19 with their product(s) and how the product(s) will be used. The reviewer needs to determine if 

20 the assumptions presented are indeed reasonable. This determination becomes particularly 

21 important if the projected doses are approaching an applicable limit. 

22 Additional discussion about the dose assessment needed to demonstrate that a product meets 

23 applicable safety criteria is provided in Appendix E of this NUREG. 

24 Response from Applicant: 

25 An applicant should provide sufficient information relating to the design, manufacture, prototype 

26 testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, 

27 and disposal of the gas and aerosol detector to demonstrate that the product will meet the 

28 safety criteria set forth in the regulations. 

29  Provide all of the information required as to the products it intends to distribute. 

30  Provide an adequate dose assessment addressing all of the appropriate scenarios to 

31 demonstrate that the device meets the safety criteria in 10 CFR 32.27, which references 

32 the table in 10 CFR 32.28. 

33  Provide information on quality control and information on product labeling. 

34 (Actual example labels and packaging are helpful.) 

35  Submit information on the safety instructions that will be provided to recipients 

36 [required by 10 CFR 32.210(c)]. 

37 Additional guidance pertaining to obtaining the registration certificate under 10 CFR 32.210 is 

38 provided in NUREG-1556, Volume 3. 
9-29 

1 Checklist for Applications Under 10 CFR 32.26

Item 

No. Suggested Response 

Description

Attached 

A Applicant satisfied general requirements in 30.33 [licensee provides 

copy of possession and use license]. 

[ ] 

B 

Applicant submitted sufficient information regarding product pertinent to 

evaluation of potential radiation exposure, to demonstrate that the 

product will meet the safety criteria set forth in 10 CFR 32.27, including: 

[ ] 

1. Description of the product and its intended use or uses 

(conforms to class) [ ] 

2. Type and quantity of byproduct material in each unit [ ] 

3. 

Chemical and physical form of the byproduct material in the product and 

changes in chemical and physical form that may occur during the useful 

life of the product 

[ ] 

4. Solubility in water and body fluids of the forms of the identified 

byproduct material [ ] 

5. 

Details of construction and design of the product as related to 

containment and shielding of the byproduct material and other safety 

features under normal and severe conditions of handling, storage, use, 

and disposal of the product 

[ ] 

6. 

Maximum external radiation levels at 5 and 25 centimeters from any 

external surface of the product, averaged over an area not to exceed 10 

square centimeters, and the method of measurement 

[ ] 

7. Degree of access of human beings to the product during normal 

handling and use [ ] 

8. Total quantity of byproduct material expected to be distributed in the 

products annually 

[ ] 

9. Expected useful life of the product [ ] 

10. Methods of labeling or marking the product and its point of 

sale packaging 

[ ] 

11. Procedures for and results of prototype testing of the product [ ] 

12. 

The estimated external radiation doses and dose commitment resulting 

from the intake of byproduct material in any one year relevant to the 

safety criteria in 10 CFR 32.27 and the basis for these estimates 

[Use table in Appendix E] 

[ ] 

13. A determination that the probabilities with respect to the doses referred 

to in 10 CFR 32.27(c) meet the criteria of that paragraph 

[ ] 

14. 

Quality control procedures to be followed in the fabrication of production 

lots of the products and the quality control standards the products will 

be required to meet 

[ ] 

15. Any additional information, including experimental studies and tests, if 

required by the NRC 

[ ] 

C 

Containment, shielding, and other safety features are not likely to be 

significantly impacted by likely wear and abuse during normal handling 

and use. 

[ ] 

D Specific scenarios analyzed in dose assessment [Use table in 

Appendix E] [ ] 
9-30 

1 9.7 10 CFR 32.30: Certain Industrial Devices 

2 Regulations: 10 CFR 30.22, 10 CFR 32.30, 10 CFR 32.31, 10 CFR 32.32, 10 CFR 32.210 

3 Criteria: Applicants for a specific license to manufacture, process, produce, or initially transfer 

4 for sale or distribution, devices containing byproduct material for use under 10 CFR 30.22 or 

5 equivalent regulations of an Agreement State apply under 10 CFR 32.30. 

6 Applicants must obtain a specific license under 10 CFR 32.30 and a registration certificate 

7 under 10 CFR 32.210 in order to distribute industrial devices for use under the exemption in 

8 10 CFR 30.22; these devices must be designed and manufactured for industrial use for the 

9 purpose of detecting; measuring; gauging; or controlling thickness, density, level, interface 

10 location, radiation, leakage; or qualitative or quantitative chemical composition, or for producing 

11 an ionized atmosphere. 

12 Note: Devices for the purpose of producing light are not covered by the exemption in 

13 10 CFR 30.22, but are covered by the exemption in 10 CFR 30.19. The exemption in 

14 10 CFR 30.22 also does not cover sources not incorporated into a device, such as calibration 

15 and reference sources. Example devices that may qualify for use under this exemption include: 

16 static eliminators and ion generators containing polonium-210, beta backscatter and 

17 transmission devices, gas chromatographs, and x-ray fluorescence analyzers. 

18 Example products 

19  static eliminators 

20  x-ray fluorescence analyzers

21 Paragraph (a) of 10 CFR 32.30 indicates that the applicant must satisfy the general 

22 requirements of 10 CFR 30.33. See Section 5.4, “Possession Licenses,” for additional 

23 information concerning possession license requirements. 

24 Paragraph (b) of 10 CFR 32.30 requires the submission of sufficient information relating to the 

25 design; manufacture; prototype testing; quality control procedures; labeling or marking; and 

26 conditions of handling, storage, use, and disposal of the industrial devices to demonstrate that 

27 the device will meet the safety criteria set forth in 10 CFR 32.31. The information must include: 

28  a description of the device and its intended use or uses 

29  type and quantity of byproduct material in each unit 

30  chemical and physical form of the byproduct material in the device and changes in 

31 chemical and physical form that may occur during the useful life of the device 

32  solubility in water and body fluids of the identified forms of the byproduct material, 

33 including any forms that arose as a result of prototype testing 

34  details of construction and design of the device as related to containment and shielding 

35 of the byproduct material and other safety features under normal and severe conditions 

36 of handling, storage, use, and disposal of the device 
9-31 

1  maximum external radiation levels at 5 and 30 centimeters from any external surface of 

2 the device, averaged over an area not to exceed 10 square centimeters, and the method 

3 of measurement 

4  degree of access of human beings to the device during normal handling and use 

5  total quantity of byproduct material expected to be distributed in the devices annually 

6  expected useful life of the device 

7  proposed methods of labeling or marking the device and its point-of-sale package to 

8 satisfy the requirements of 10 CFR 32.32(b), which include providing safety instructions 

9  procedures for prototype testing of the device to demonstrate the effectiveness of the 

10 containment, shielding, and other safety features under both normal and severe 

11 conditions of handling, storage, use, and disposal of the device 

12  results of the prototype testing of the device, including any change in the form of the 

13 byproduct material contained in the device, the extent to which the byproduct material 

14 may be released to the environment, any increase in external radiation levels, and any 

15 other changes in safety features 

16  estimated external radiation doses and committed doses resulting from the intake of 

17 byproduct material in any one year relevant to the safety criteria in 10 CFR 32.31 and 

18 the basis for these estimates 

19  a determination that the probabilities, with respect to the doses referred to in 

20 10 CFR 32.31(a)(4), meet the criteria of that paragraph 

21  quality control procedures to be followed in the fabrication of production lots of the 

22 devices and the quality control standards the devices will be required to meet 

23 The applicant must also supply any additional information, including experimental studies and 

24 tests, if required by the NRC. 

25 The dose assessment submitted under 10 CFR 32.30(b)(13) to demonstrate that the device 

26 meets the safety criteria in 10 CFR 32.31 must be consistent with all of the other information 

27 submitted about the device under 10 CFR 32.30(b). 

28 Paragraph (c) of 10 CFR 32.210 also requires certain information to be submitted as a basis for 

29 registering the device. Generally, the requirements of 10 CFR 32.30 cover the same categories 

30 of information in a more detailed manner but are not a complete substitute for meeting the 

31 requirements of 10 CFR 32.210(c). Paragraph (d) of 10 CFR 32.210 refers to Subpart A of 

32 10 CFR Part 32 for the additional criteria for certain exempt products. Thus, the criteria in 

33 10 CFR 32.30 and 32.31 discussed here are also considered in the registration process. 

34 Conditions for any license issued under 10 CFR 32.30 appear in 10 CFR 32.32. 

35 In addition to providing the basis for demonstrating that a device meets the safety criteria of 

36 10 CFR 32.31, there are other purposes for the information required to be submitted under 

37 10 CFR 32.30: 
9-32 

1  The information on quality control procedures submitted under 10 CFR 32.30(b)(15) will 

2 supply the basis for meeting the requirements of 10 CFR 32.32(a). 

3  The information on labeling submitted under 10 CFR 32.30(b)(10) will form the basis for 

4 meeting the requirements of 10 CFR 32.32(b) and must be consistent with those 

5 requirements. 

6 Paragraph (c) of 10 CFR 32.32 specifies the requirements for records and reporting. 

7 Information concerning the recordkeeping and reporting requirements are not required to be 

8 included in the application, because the requirements are fully specified in the regulations. 

9 Details concerning recordkeeping and annual reporting requirements can be found in 

10 Appendix B in this NUREG. 

11 The certificate holder is also subject to 10 CFR 32.210(f), which requires that the product be 

12 manufactured and distributed in accordance with the statements and representations made by 

13 the applicant and the provisions of the registration certificate. 

14 Discussion: The use of the term, “industrial devices,” is intended to preclude the distribution of 

15 products that may be routinely used in residences. Although an exemption from licensing is not 

16 limited to any certain category of user, the products to be approved for use under this exemption 

17 should be intended for marketing to such end users as commercial and industrial firms; 

18 research, educational, and medical institutions; and Federal, State, and local government 

19 agencies. The inclusion of medical institutions as a potential recipient market is not intended to 

20 imply that devices intended for “medical use,” as defined in Part 35, are covered by this 

21 exemption. It is required that the device is unlikely to be routinely used by members of the 

22 general public in a nonoccupational environment. The license application and registration 

23 certificate reviewers should consider whether a product could potentially be marketed to 

24 consumers for home use even if the applicant indicates that it is intended for occupational use. 

25 Information on the description of the device and its intended uses [10 CFR 32.30(b)(1)] serves a 

26 number of purposes. The first consideration is whether the device in fact belongs in the 

27 exempted class of products. The device must be for one of the identified purposes. Note that 

28 byproduct material produces ionizing radiation and may in any situation produce some ionized 

29 atmosphere. In order for a device to fall into the exempted class, based on the purpose of 

30 producing an ionized atmosphere, this must be the desired end result of the product, such as in 

31 a static eliminator. 

32 Information on the device and its intended uses also provides the primary basis for determining 

33 whether the device could lend itself to an application of use by the general public in a 

34 nonoccupational setting. For example, a small hand-held static eliminator, though intended for 

35 use by a certain industry, might lend itself to getting into consumer markets. In this particular 

36 case, an exemption for static eliminators available to the general public is contained in 

37 10 CFR 30.15(a)(2). 

38 Applicants should list all models of each type of product they wish to distribute. As discussed in 

39 Section 9.5, “10 CFR 32.22: Self Luminous Products Containing Tritium, Krypton 85, or 

40 Promethium 147,” applicants may request to have models listed as a series, or multiple models 

41 or series on a single registration certificate. In order to have the models listed as a series, the 

42 models should be essentially the same, with respect to factors affecting radiological safety. In 

43 order to have models or series of models listed on the same certificate, there should be 

44 similarities in the design and construction of the devices. 
9-33 

1 Applicants should provide detailed engineering drawings of each basic model in each series 

2 with a list of the differences between the models in each series and for the models or series 

3 proposed to be registered on the same certificate. Applicants should provide detailed 

4 engineering drawings of each basic device in each series with a list of the differences between 

5 the models in that series. The drawings should clearly show all dimensions and tolerances, 

6 describe or identify the construction materials, and provide the details of the source mounting. 

7 This information must be provided for each type of material used such as steel, aluminum, 

8 or plastic. 

9 Models or series on the same certificate would be differentiated by such differences as size, 

10 construction, radionuclide, and source activity. For example, the Series 200 is larger in size 

11 than the basic Series 100, and the Series 300 has a larger source activity than either the 100 

12 or 200. 

13 Models contained within each series are the same basic model, with cosmetic differences 

14 such as lights and timers. For example, a basic model designated as the Series 100 could 

15 be registered to include the 100A model with a 3-second timer, and the 100B with a 

16 5-second timer. 

17 Unique aspects of the class exemption for industrial products (10 CFR 30.22) 

18 The safety criteria in 10 CFR 32.30 for the class exemption for industrial products specifically 

19 requires that the analysis consider how many of a product are likely to accumulate in one place 

20 in all stages of the life cycle of the product after it leaves the control of the specific licensee 

21 manufacturer and/or distributor. The number likely to be in one place is different in each stage 

22 of the life cycle of the product. The criterion of 200 μSv [20 mrem]/year in 10 CFR 32.31(a)(1) 

23 applies to use, handling, and storage, including marketing, distribution, installation, and 

24 servicing of the device. Depending on the nature of the product, a user might typically only be 

25 in close proximity to one device at a time or several. In the case of static eliminators used in 

26 some industries, such as the paper industry, many may be used in a line. In some industries, a 

27 significant number of a type of device might be stored in the same place, but the amount of time 

28 spent in proximity during storage might be limited. For some types of devices that require 

29 servicing, servicing may be done exclusively by individuals assigned this as a duty, who may be 

30 exposed routinely to a significant number of devices. A distributor should be able to make 

31 reasonable assumptions about the industries that they expect to serve with their product(s). 

32 The reviewer needs to determine if the assumptions presented are indeed reasonable. This 

33 determination becomes particularly important if the projected doses are approaching an 

34 applicable limit. 

35 The criterion for disposal in 10 CFR 32.31(a)(2) is 10 μSv [1 millirem (mrem)]/year. This 

36 involves estimating the number of units likely to be disposed of in the same disposal site, 

37 landfill, municipal incinerator, or, if applicable, scrap metal recycling facility. 

38 The criterion for accidents is 10 CFR 32.31(a)(4) and applies to possible accidents during use, 

39 handling, storage, and disposal, including during marketing, distribution, installation, and 

40 servicing of the device. Specifically, 10 CFR 32.31(a)(4) requires that the probability is low that 

41 the containment, shielding, or other safety features of the device would fail under such 

42 circumstances that a person would receive an external radiation dose or committed dose in 

43 excess of 5 mSv [500 mrem], and the probability is negligible that a person would receive an 

44 external radiation dose or committed dose of 100 mSv [10 rem] or greater. Paragraph (b) in 

45 10 CFR 32.31 specifies misuse scenarios that must be analyzed, regardless of how 
9-34 

1 well-contained the byproduct material might be in the device. The dose to a person who spends 

2 1000 hours at 1 meter from the unshielded source must not exceed 100 mSv [100 rem]; this 

3 dose must also not be exceeded if a person were to intake (whether by inhalation, ingestion, or 

absorption through the skin) 10-4 4 (or 10 percent in the case of tritium) of the total byproduct 

5 material in the device. An additional criterion applies if the source within the device is small 

6 enough to put in one’s pocket. That criterion is that the dose to localized areas of skin averaged 

7 over areas no larger than 1 square centimeter from carrying the unshielded source in a pocket 

8 for 80 hours will not exceed 2 Sv [200 rem]. This provision effectively puts a quantity limit on 

9 the particular radionuclide that can be used in a device to be exempted under 

10 10 CFR 30.22; it is not, however, the primary means of ensuring adequate safety of users and 

11 others exposed to the device being considered. 

12 The safety criteria in 10 CFR 32.31 use the term “committed dose,” which is defined in 

13 10 CFR 32.2, “Definitions,” as follows: “[F]or the purposes of this part [committed dose] means 

14 the radiation dose that will accumulate over time as a result of retention in the body of 

15 radioactive material. Committed dose is a generic term for internal dose and must be calculated 

16 by summing the projected dose over the 50 years after intake for all irradiated organs or tissues 

17 multiplying the doses to individual organs and tissues by applicable tissue weighting factors.” 

18 The NRC normally accepts dose estimates based on the weighting factors in Part 20 

19 Appendix B or the tissue weighting factors in ICRP 60, “1990 Recommendations of the 

20 International Commission on Radiological Protection,” or ICRP 103, “The 2007 

21 Recommendations of the International Commission on Radiological Protection,” which provides 

22 certain updates to ICRP 60. 

23 For products proposed for use under the class exemption for industrial products, it is acceptable 

24 to perform an analysis utilizing dose conversion factors (DCFs) from ICRP 30, “Limits for 

25 Intakes of Radionuclides by Workers,” and ICRP 32, “Limits for Inhalation of Radon Daughters 

26 by Workers” (based on ICRP 26, “Recommendations of the International Commission on 

27 Radiological Protection”), or ICRP 68, “Dose Coefficients for Intakes of Radionuclides by 

28 Workers,” and ICRP 72, “Age-dependent Doses to the Members of the Public from Intake of 

29 Radionuclides - Part 5 Compilation of Ingestion and Inhalation Coefficients” (based on ICRP 

30 60), and newer DCFs when made available based on later recommendations of the ICRP. 

31 In a rare instance, the NRC may consider whether use of certain dose methodology may call 

32 into question whether the product presents an inappropriate level of risk. For example an 

33 inappropriate level of risk may occur if the DCF used for a radionuclide is significantly lower than 

34 the latest version, and the margin of safety is small given the level of uncertainty and the degree 

35 of conservatism in the analysis. 

36 Appendix E of this NUREG provides additional discussion about the dose assessment needed 

37 to demonstrate that a product meets applicable safety criteria. 

38 Response from Applicant: 

39 An applicant should provide sufficient information relating to the design, manufacture, prototype 

40 testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, 

41 and disposal of the industrial devices to demonstrate that the device will meet the safety criteria 

42 set forth in the regulations. 
9-35 

1  Provide all of the information required as to the products the applicant intends 

2 to distribute. 

3  Provide an adequate dose assessment addressing all of the appropriate scenarios to 

4 demonstrate that the device meets the safety criteria in 10 CFR 32.31. 

5  Provide information on quality control and information on product labeling. 

6 (Actual example labels are helpful.) 

7  Submit information on the safety instructions that will be provided to recipients. 

8 Additional guidance pertaining to obtaining the registration certificate under 10 CFR 32.210 is 

9 provided in NUREG-1556, Volume 3. 

10 Checklist for Applications Under 10 CFR 32.30

Item 

No. Suggested Response 

Description

Attached 

A Applicant satisfied general requirements in 30.33 [licensee provides 

copy of possession and use license]. [ ] 

B 

Applicant submitted sufficient information regarding product pertinent to 

evaluation of potential radiation exposure, to demonstrate that the 

product will meet the safety criteria set forth in 10 CFR 32.31, including: 

[ ] 

1. Description of the product and its intended use or uses (conforms to 

class) [ ] 

2. Type and quantity of byproduct material in each unit [ ] 

3. 

Chemical and physical form of the byproduct material in the product and 

changes in chemical and physical form that may occur during the useful 

life of the device 

[ ] 

4. Solubility in water and body fluids of the forms of the identified 

byproduct material [ ] 

5. 

Details of construction and design of the product as related to 

containment and shielding of the byproduct material and other safety 

features under normal and severe conditions of handling, storage, use, 

and disposal of the device 

[ ] 

6. 

Maximum external radiation levels at 5 and 25 centimeters from any 

external surface of the product, averaged over an area not to exceed 10 

square centimeters, and the method of measurement 

[ ] 

7. Degree of access of human beings to the product during normal 

handling and use [ ] 

8. Total quantity of byproduct material expected to be distributed in the 

products annually 

[ ] 

9. Expected useful life of the product [ ] 

10. Methods of labeling or marking the product and its point of sale 

packaging 

[ ] 

11. Procedures for and results of prototype testing of the device [ ] 

12. The estimated external radiation doses and dose commitment resulting [ ] 
9-36 

Item 

No. Suggested Response 

Description

Attached 

from the intake of byproduct material in any one year relevant to the 

safety criteria in 10 CFR 32.27 and the basis for these estimates [Use 

table in Appendix E] 

13. A determination that the probabilities with respect to the doses referred 

to in 10 CFR 32.31(a)(4) meet the criteria of that paragraph 

[ ] 

14. 

Quality control procedures to be followed in the fabrication of production 

lots of the products and the quality control standards the products will 

be required to meet 

[ ] 

15. Any additional information, including experimental studies and tests, if 

required by the NRC 

[ ] 

C 

Containment, shielding, and other safety features are not likely to be 

significantly impacted by likely wear and abuse during normal handling 

and use. 

[ ] 

D Specific scenarios analyzed in dose assessment [Use table in 

Appendix E]. [ ] 

E Any other requirements for issuance of the registration certificate have 

been satisfied. [ ] 

1 9.8 10 CFR 40.52: Certain Items Containing Source Material 

2 Regulations: 10 CFR 40.13(c), 10 CFR 40.31, 10 CFR 40.32, 10 CFR 40.52, 10 CFR 40.53 

3 Criteria: Applicants for a specific license to apply source material to, incorporate source 

4 material into, manufacture, process, or produce the products specified in 10 CFR 40.13(c) or to 

5 initially transfer for sale or distribution any products containing source material for use under 

6 10 CFR 40.13(c) or equivalent provisions of an Agreement State apply under 10 CFR 40.52, 

7 “Certain Items Containing Source Material; Requirements for License To Apply or Initially 

8 Transfer.” 

9 Applicants must obtain a specific license under 10 CFR 40.52 to apply source material to, 

10 incorporate source material into, manufacture, process, produce, or initially transfer for sale 

11 or distribution the products listed in the Tables 9-7 through 9-21 of this NUREG in the 

12 United States. 

Table 9-7. 10 CFR 40.13(c)(1)(i) Incandescent Gas Mantles 

Source Material Maximum Quantity/Concentration

Thorium No limit 

Table 9-8. 10 CFR 40.13(c)(1)(ii) Vacuum Tubes

Source Material Maximum Quantity/Concentration

Thorium No limit 
9-37 

Table 9-9. 10 CFR 40.13(c)(1)(iii) Welding Rods 

Source Material Maximum Concentration

Thorium No limit 

Table 9-10. 10 CFR 40.13(c)(1)(iv) Electric Lamps for Illuminating Purposes 

Source Material Maximum Quantity Per Lamp

Thorium 50 milligrams 

Table 9-11. 10 CFR 40.13(c)(1)(v) Germicidal Lamps, Sunlamps, and Lamps for Outdoor 

or Industrial Lighting 

Source Material Maximum Quantity Per Lamp

Thorium 2 grams 

Table 9-12. 10 CFR 40.13(c)(1)(vi) Rare Earth Metals and Compounds, Mixtures, and 

Products 

Source Material Maximum Concentration

Thorium, uranium, or combination 0.25 percent by weight 

Table 9-13. 10 CFR 40.13(c)(1)(vii) Personnel Neutron Dosimeters 

Source Material Maximum Quantity Per Dosimeter 

Thorium 50 milligrams 

Table 9-14. 10 CFR 40.13(c)(2)(ii) Piezoelectric Ceramic 

Source Material Maximum Concentration

Uranium or thorium 2 percent by weight 

Table 9-15. 10 CFR 40.13(c)(2)(iii) Glassware, Not Including Commercially 

Manufactured Glass Brick, Pane Glass, Ceramic Tile, or Other Glass or 

Ceramic Used in Construction 

Source Material Maximum Concentration

Uranium or thorium 2 percent by weight (up to 10 percent by weight if 

manufactured before August 27, 2013) 

Table 9-16. 10 CFR 40.13(c)(3) Photographic Film, Negatives, and Prints 

Source Material Maximum Concentration 

Uranium or thorium No limit 
9-38 

Table 9-17. 10 CFR 40.13(c)(4) Any Finished Product or Part Fabricated of, or 

Containing Tungsten or Magnesium Thorium Alloys 

Source Material Maximum Concentration Additional Restrictions

Thorium 4 percent by weight 

The exemption does not authorize the 

chemical, physical, or metallurgical 

treatment or processing of any such 

product or part 

Table 9-18. 10 CFR 40.13(c)(5) Uranium Contained in Counterweights Installed in 

Aircraft, Rockets, Projectiles, and Missiles, or Stored or Handled in 

Connection With Installation or Removal of Such Counterweights 

Source Material Maximum Concentration Additional Restrictions

Uranium No limit 

Each counterweight has been impressed 

with, “Depleted Uranium,” clearly legible 

through any plating or other 

covering;1

Each counterweight is durably 

and legibly labeled or marked with the 

identification of the manufacturer, and the 

statement: “Unauthorized Alterations 

Prohibited”;1 

The exemption does not authorize the 

chemical, physical or metallurgical 

treatment or processing of any such 

counterweight other than repair or 

restoration of any plating or other 

covering; 

Consistent with 10 CFR 40.56, 

“Restrictions on the use of 

Australian-obligated source material,” the 

counterweights are not manufactured for 

a military purpose using 

Australian-obligated source material 

 

 

1

These labeling requirements need not be met by counterweights manufactured prior to Dec. 31, 1969: Provided that 

such counterweights were manufactured under a specific license issued by the Atomic Energy Commission and were 

impressed with the legend required by 10 CFR 40.13(c)(5)(ii) in effect on June 30, 1969. 
9-39 

Table 9-19. 10 CFR 40.13(c)(6) Natural or Depleted Uranium Metal Used as Shielding 

Constituting Part of Any Shipping Container 

Source Material Maximum Quantity/ 

Concentration

Additional Restrictions

Uranium No limit 

The shipping container is conspicuously 

and legibly impressed with the legend 

“CAUTION—RADIOACTIVE 

SHIELDING—URANIUM”; 

The uranium metal is encased in mild 

steel or equally fire-resistant metal of 

minimum wall thickness of 1/8 inch 

[3.2 mm]. 

Table 9-20. 10 CFR 40.13(c)(7) Thorium or Uranium Contained in or on Finished Optical 

Lenses and Mirrors 

Source Material Maximum Concentration Additional Restrictions

Thorium or uranium 10 percent by weight (up to 

30 percent by weight of 

thorium was allowed in 

lenses manufactured before 

August 27, 2013) 

The exemption does not authorize either: 

The shaping, grinding or polishing of such 

lens or manufacturing processes other 

than the assembly of such lens into 

optical systems and devices without any 

alteration of the lens; or 

The receipt, possession, use, or transfer 

of thorium contained in contact lenses, or 

in spectacles, or in eyepieces in 

binoculars or other optical instruments. 

Table 9-21. 10 CFR 40.13(c)(8) Finished Aircraft Engine Parts Containing Nickel 

Thoria Alloy 

Source Material Maximum Concentration Additional Restrictions 

Thorium 4 percent by weight 

The thorium is dispersed in the 

nickel-thoria alloy in the form of finely 

divided thoria (thorium dioxide). 

1 An example of products covered by a product exemption in 10 CFR 40.13(c) are depleted 

2 uranium counterweights. 

3 This section also contains exemptions for certain products previously manufactured: 

4  10 CFR 40.13(c)(2)(i) Glazed ceramic tableware, glaze not to exceed 20 percent by 

5 weight source material manufactured before August 27, 2013 

6  10 CFR 40.13(c)(2)(iv) Glass enamel or glass enamel frit containing not more than 

7 10 percent by weight source material imported or ordered for importation into the 
9-40 

1 United States, or initially distributed by manufacturers in the United States, before 

2 July 25, 1983. 

3 As no new manufacture or initial distribution is allowed, these products will not be discussed 

4 further in this document. 

5 In accordance with 10 CFR 40.52, the applicant should provide the following information about 

6 the product: 

7 Sufficient information regarding the product pertinent to the evaluation of the potential radiation 

8 exposures, including: 

9 (1) Chemical and physical form and maximum quantity of source material in each product; 

10 (2) Details of construction and design of each product, if applicable. For coated lenses, this 

11 must include a description of manufacturing methods that will ensure that the coatings 

12 are unlikely to be removed under the conditions expected to be encountered during 

13 handling and use; 

14 (3) For products with applicable quantity or concentration limits, quality control procedures 

15 to be followed in the fabrication of the product (or production lots) and the quality control 

16 standards the product will be required to meet; 

17 (4) The proposed method of labeling and/or marking each unit or its container with the 

18 identification of the manufacturer or initial transferor of the product and the source 

19 material in the product; and 

20 (5) For incandescent gas mantles or welding rods, the means of providing radiation safety 

21 precautions and instructions relating to handling, use, and storage. 

22 Conditions for any license issued under 10 CFR 40.52 appear in 10 CFR 40.53, “Conditions for 

23 Licenses Issued for Initial Transfer of Certain Items Containing Source Material: Quality Control, 

24 Labeling, and Records and Reports.” 

25 In addition to contributing to the evaluation of the potential radiation exposures from a product, 

26 there are other purposes for the information required to be submitted under 10 CFR 40.52: 

27  The information on quality control submitted under 10 CFR 40.52(b)(3), if applicable, will 

28 supply the basis for meeting the requirements of 10 CFR 40.53(a). 

29  The information on labeling submitted under 10 CFR 40.52(b)(4) will form the basis for 

30 meeting the requirements of 10 CFR 40.53(b). 

31 Paragraph (c) of 10 CFR 40.53 specifies the requirements for records and reporting. 

32 Information concerning the recordkeeping and reporting requirements are not required to be 

33 included in the application, because the requirements are fully specified in the regulations. 

34 However, the applicant needs to be aware of these responsibilities. Details concerning 

35 recordkeeping and annual reporting requirements can be found in Appendix B. 
9-41 

1 Discussion: As the type of products covered by the exemptions in 10 CFR 40.13(c) vary 

2 considerably, there will be a variation in the amount and type of information that the NRC will 

3 find acceptable in the application for a license under 10 CFR 40.52. 

4 Chemical and physical form and maximum quantity per product 

5 With regard to 10 CFR 40.52(b)(1): A “physical form” description might include such information 

6 as whether the product is made of metal, a metal alloy, a ceramic mixture, or other material. 

7 Physical form may be best described as the properties of materials and how those properties 

8 are determined by the material’s composition and structure, both macroscopic and microscopic. 

9 The “chemical form” of the source material would be the actual chemical or molecular formula 

10 that identifies each constituent element by its chemical symbol and indicates the number of 

11 atoms of each element found in each discrete molecule of that compound. Examples include 

12 uranium dioxide (UO2) or triuranium octaoxide (U3O8) (the most stable form of uranium and the 

13 one most commonly found in nature). 

14 The maximum quantity per product would be the total mass/weight of source material in each 

15 product. In some cases, there are weight limits or weight percent limits in the exemptions; thus, 

16 the NRC would be able to use this information to ensure that the products will remain within the 

17 constraints of the exemption. In addition, for any of the exemptions, the maximum weight/mass 

18 would help the NRC to evaluate the health and safety impacts of the products being distributed. 

19 If there is significant variation in the products, some general information should be provided on 

20 the ranges of sizes and weights, or lists of models with more specific information. For example, 

21 the most important information for shipping containers in which natural or depleted uranium 

22 metal is used as shielding would be about the labeling and encasement, to show that they will 

23 meet the constraints in the exemption [10 CFR 40.13(c)(6)]. 

24 Details of construction and design 

25 With regard to 10 CFR 40.52(b)(2): Because of the variety of product types identified in 

26 10 CFR 40.13(c), the extent of information about the details of construction and design will vary 

27 depending on the product. If there are significant variations in similar product types planned to 

28 be initially distributed, an applicant may provide general information about the ranges of sizes 

29 and weights, or lists of models, but should provide more specific information, where practical. 

30 For some products, such as welding rods; rare earth metals, compounds, and mixtures; 

31 glassware; and photographic film, negatives, and prints, sufficient information may be a 

32 description of the product and variations planned to be initially distributed. For other products, 

33 such as incandescent gas mantles, electric lamps, and tungsten parts, drawings and other 

34 details of the products may be necessary in addition to a description because such additional 

35 information may be important in evaluating the safety of the product. 

36 In many cases, operating manuals, descriptive sales literature, or similar documents may 

37 include relevant information and may be submitted as part of an application. 

38 If applicable to the type of product (e.g., a finished manufactured product), the applicant should 

39 describe construction aspects of the product, including components of the product, materials of 

40 construction, dimensions, and assembly methods. An overall drawing of the product identifying 

41 primary components and indicating overall dimensions is useful as a complement to the written 

42 description of the product. This is not applicable for products such as rare earth compounds 

43 being distributed in bulk. 
9-42 

1 Quality control procedures (for products with applicable quantity or concentration limits) 

2 With regard to 10 CFR 40.52(b)(3): To meet this requirement, the applicant would primarily 

3 need to describe how the distributor will ensure that the product does not exceed any applicable 

4 limit in the exemption. The assurance may be shown through calculation, description of existing 

5 quality assurance programs, or, if necessary, through batch sampling. The means of ensuring 

6 that items or packaging include labeling, and safety instructions when applicable, should also be 

7 addressed. The NRC may also require information about certain aspects of training, 

8 experience, facilities, and equipment that is relevant to allowing the NRC to assess applicant’s 

9 ability to ensure that the activity or concentration limits are not exceeded. Although 

10 10 CFR 40.52(a) eliminates the need for discussing training and experience and facilities and 

11 equipment in relation to ensuring radiation protection for those persons located in Agreement 

12 States or importing finished products, the information required as part of 40.52(b)(3) is in 

13 relation to the applicant’s quality control program. 

14 Proposed method of labeling or marking 

15 With regard to 10 CFR 40.52(b)(4): All of the exempted products require labeling, but two of the 

16 exemptions include a specific labeling requirement: 10 CFR 40.13(c)(5) for counterweights, and 

17 10 CFR 40.13(c)(6) for shipping containers. Thus, applicants to distribute one of these products 

18 must ensure that their labeling will be consistent with those requirements of the exemption. 

19 For all products to be distributed for use under 10 CFR 40.13(c), the applicant shall submit 

20 information on labeling to identify the manufacturer or distributor and the type of source material 

21 (i.e., simply uranium and/or thorium). The term “source material” should not be used in lieu of 

22 “uranium” or “thorium.” Applicants may provide samples or copies of labels or packaging, 

23 although descriptions could be acceptable. Many of the products covered by the exemptions 

24 are not practical to label; so it is possible that in some cases only the packaging would be 

25 labeled. Glassware is typically labeled either with impressions or small stickers to identify the 

26 manufacturer. For some products, the initial recipient would need some information about the 

27 identity and quantity or concentration of source material. In such cases, packaging or 

28 accompanying paperwork would provide the information. In most cases, the identification of the 

29 manufacturer or distributor and the fact that thorium or uranium is present should appear on 

30 point-of-sale packaging. Labels on packaging of multiple lenses, for example, should be 

31 adequate as long as the information applies to all of the lenses in the package, and as long as 

32 this package is what the person installing them into a product will be receiving. It would not be 

33 appropriate to only provide it on an outer package that would be expected to be removed by 

34 someone other than the person installing the lenses. 

35 Proposed means of providing radiation safety precautions and instructions 

36 With regard to 10 CFR 40.52(b)(5): For welding rods and gas mantles containing thorium, the 

37 applicant shall provide information on how instructions are to be provided to customers. In most 

38 cases, either a label or an accompanying product brochure should contain instructions for the 

39 proper handling, use, storage, and disposal of the radioactive material. The label or brochure 

40 should include basic radiation safety practices applicable to the particular product. For 

41 example, in the case of either welding rods or gas mantles, minimizing intakes of thorium is the 

42 primary point. The instructions should address the importance of ventilation and minimizing 

43 handling. The hazards presented by the dust created from grinding tips should specifically be 

44 addressed. The safety information should be packaged or labeled such that it will be available 

45 to the ultimate user of the product. 
9-43 

1 Distributors of gas mantles have included such precautions on the wrap on the individual 

2 mantles. This is the preferred practice, although brochures provided with packages of small 

3 numbers of mantles may also be acceptable, if it is included in the package expected to be 

4 received by the consumer. For welding rods, information on radiation safety may be provided in 

5 material safety data sheets (MSDSs); if the MSDS is the only means of informing users, the 

6 radiological aspects of hazards would need to be adequately addressed. 

7 Unique aspects of the exemptions in 10 CFR 40.13(c) 

8 Per the requirements in 10 CFR 40.13(c)(10)(ii), if the applicant is only planning to import 

9 finished products containing source material that fall under an exemption in 10 CFR 40.13(c) or 

10 an Agreement State equivalent provision and to distribute those products without any 

11 modification, the applicant would only need to apply for a specific license for initial distribution 

12 issued under 10 CFR 40.52. In this situation, the applicant does not need to apply for a 

13 possession license. Because the applicant is only receiving a license for distribution of source 

14 material, the applicant would only be responsible to the NRC for a license application fee and 

15 annual fees for the distribution license. Additional guidance about the source material 

16 regulations concerning exemptions from licensing is available in Appendix F of this NUREG in 

17 the form of questions and answers. 

18 Response from Applicant: 

19  Provide all of the information required as to the products the applicant intends 

20 to distribute. 

21  Provide information on quality control, if applicable, and information on product labeling. 

22  Submit information on the safety instructions that will be provided to recipients, 

23 if applicable. 

24 Checklist for Applications Under 10 CFR 40.52

Item 

No. Suggested Response 

Description

Attached 

A 

Applicant satisfied general requirements in 10 CFR 40.32, “General 

Requirements for Issuance of Specific Licenses” [licensee provides 

copy of possession and use license], except for importers of finished 

products. 

[ ] 

B Applicant submits sufficient information regarding product pertinent to 

evaluation of potential radiation exposures, including: [ ] 

1. Chemical and physical form and maximum quantity of source material 

in each product [ ] 

2. 

Details of construction and design of each product, if applicable. If 

coated lenses, describes manufacturing methods to ensure coatings 

are unlikely to be removed under conditions expected during handling 

and use 

[ ] 

3. For products with applicable quantity or concentration limits, quality 

control procedures and standards the product will be required to meet [ ] 
9-44 

Item 

No. Suggested Response 

Description

Attached 

4. 

Method of labeling or marking each unit, and/or its container with the 

identification of the manufacturer or initial transferor of the product and 

the source material in the product 

[ ] 

5. 

Means of providing radiation safety precautions and instructions relating 

to handling, use, and storage of incandescent gas mantles or welding 

rods, if applicable 

[ ] 

C 

Applicant assures that each product will contain no more than the 

quantity or the concentration of source material specified for that 

product in 10 CFR 40.13(c). 

[ ] 
10-1 

1 10 LICENSE AMENDMENTS AND RENEWALS 

2 It is the licensee’s obligation to keep the license current. If any of the information provided in 

3 the original application is to be modified or changed, the licensee must submit an application for 

4 a license amendment before the change takes place. The change is not in effect until the 

5 amendment has been issued. Also, to continue the license after its expiration date, the licensee 

6 must submit an application for a license renewal at least 30 days before the expiration date 

7 Title 10 of the Code of Federal Regulations (10 CFR) [10 CFR 2.109(a), 10 CFR 30.36(a), 

8 10 CFR 40.42(a)]. 

9 Applicants for license amendment or renewal should do the following: 

10  Use the most recent guidance in preparing an amendment or renewal request. 

11  Submit either an NRC Form 313 or a letter requesting amendment or renewal. 

12  Provide the license number and docket number. 

13  For renewals, provide a complete and up-to-date application, including all required program 

14 elements. For the convenience and streamlined handling of exempt distribution licensing 

15 applications, the licensee should view the detailed source and product information for 

16 the distribution license as outlined in the applicable section of 10 CFR Part 32 or Part 40 

17 and discussed in Chapter 9, “Information Required for Specific Types of Distribution 

18 Licenses,” of this NUREG. 

19 If a renewal application is not received by NRC at least 30 days before the expiration date, the 

20 licensee will be without a valid license when the license expires. If the license expires, exempt 

21 distribution activities are no longer authorized, and the licensee must cease all distribution 

22 activities until a new license is obtained. Once the license expires, the licensee must submit an 

23 application package for a new license. 

24 Licensees not wishing to renew their distribution license should send a letter to the NRC before 

25 the expiration date of the license with a request that the license be terminated (see Chapter 13). 

26 Material transfer reports required by 10 CFR 32.12, 10 CFR 32.16, 10 CFR 32.20, 

27 10 CFR 32.25, 10 CFR 32.29, 10 CFR 32.32, and 10 CFR 40.53 are to be submitted within 

28 30 days of ceasing distribution. 

29 Note: Amending or changing the exempt distribution license may also require an amendment of 

30 the device registration sheet for additions, deletions, or modifications to models of sealed 

31 sources or devices to be distributed. 

32 10.1 Timely Notification of Transfer of Control 

33 Regulation: 10 CFR 30.34(b), 10 CFR 40.46 

34 Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

35 consent before transferring control of the license, also referred to as a “change of ownership” 

36 and/or “transferring the license.” 

37 Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

38 transfers. Although it is not the NRC’s intent to interfere with the business decisions of 
10-2 

1 licensees, under 10 CFR 30.34(b) and the Atomic Energy Act, licensees must obtain prior NRC 

2 written consent before transferring control of the license to ensure the following: 

3  Radioactive materials are possessed, used, or controlled only by persons who have valid 

4 NRC licenses or Agreement State licenses. 

5  Materials are properly handled and secured. 

6  Persons using these materials are capable, competent, and committed to implementing 

7 appropriate radiological controls. 

8  A clear chain of custody is established to identify who is responsible for disposition of 

9 records and licensed material. 

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

11 Most of these matters relate to the transfer of the possession license. With respect to the 

12 distribution license, the main issue would be to coordinate the action with the transfer of the 

13 possession license and ensure that the appropriate possession license is in place before 

14 transfer of the distribution license. In addition, there may be such considerations as the training 

15 and experience of persons responsible for ensuring that only products that meet all of the 

16 approved specifications are transferred for use under the respective exemption. 

17 Response from Applicant: No response is required from an applicant for a new license. 

18 However, current licensees should refer to NUREG-1556, Volume 15, “Consolidated Guidance 

19 About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving 

20 Byproduct, Source, or Special Nuclear Materials Licenses,“ for more information about transfer 

21 of control (i.e., ownership). 

Reference: For further information, see Regulatory Issue Summary (RIS) 2014-08, Rev. 1, 

“Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials 

Licenses,” dated May 5, 2016. This RIS can also be found on the NRC’s Generic 

Communications Web page under “Regulatory Issue Summaries:” http://www.nrc.gov/readingrm/doc-collections/gen-comm/. 

22 10.2 Notification of Bankruptcy Proceedings 

23 Regulation: 10 CFR 30.34(h), 10 CFR 40.41(f)(1) 

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

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

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

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

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

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

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

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

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

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

34 Justice (DOJ) represent the NRC’s interests in the bankruptcy proceeding. 
10-3 

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

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

3 involuntary petition for bankruptcy by or against the licensee. The licensee should also inform 

4 the Director, Office of Nuclear Material Safety and Safeguards, because the distribution license 

5 is issued by NRC headquarters. 

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

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

8 Special Nuclear Materials Licenses.”

11-1 

1 11 APPLICATIONS FOR EXEMPTIONS 

2 Regulations: Title 10 of the Code of Federal Regulations (10 CFR) 19.31, 

3 10 CFR 20.2301, 10 CFR 30.11, 10 CFR 40.14 

4 Criteria: Licensees may request exemptions from U.S. Nuclear Regulatory Commission (NRC) 

5 regulations. The licensee must demonstrate that the exemption is authorized by law; will not 

6 endanger life, property, or the common defense and security; and is otherwise in the public 

7 interest. Licensees may also use existing specific exemptions outlined in 10 CFR regulations if 

8 they meet the established criteria. 

9 Discussion: Various sections of the NRC’s regulations address requests for exemptions 

10 (e.g., 10 CFR 19.31, “Application for exemptions;” 10 CFR 20.2301, “Applications for 

11 exemptions;” 10 CFR 30.11 and 10 CFR 40.14, “Specific exemptions”). These regulations state 

12 that the NRC may grant an exemption, acting on its own initiative or on an application from an 

13 interested person. 

14 Exemptions are not intended to revise regulations or apply to large classes of licensees and are 

15 generally limited to unique situations. Requests for exemptions submitted to the NRC must 

16 identify the regulation for which the exemption is being requested and include a justification for 

17 the requested exemption. 

Unless the NRC has granted an exemption in writing, licensees must comply with all 

applicable regulations. 

12-1 

1 12 TERMINATION OF ACTIVITIES 

2 In accordance with Title 10 of the Code of Federal Regulations (10 CFR) 30.36 and 

3 10 CFR 40.42, “Expiration and termination of licenses and decommissioning of sites and 

4 separate buildings or outdoor areas,” exempt distribution licensees may request termination of 

5 their U.S. Nuclear Regulatory Commission (NRC) license at any time. A licensee must notify 

6 the NRC within 60 days of its decision to permanently cease distribution or within 24 months 

7 after distribution has ceased. This request may occur prior to decommissioning and must occur 

8 prior to termination of any associated possession licenses. 

9 In accordance with 10 CFR 32.211, a holder of a registration certificate who no longer intends to 

10 manufacture or initially transfer a sealed source or device shall request inactivation of the 

11 registration certificate. Such a request shall normally be made no later than 2 years after the 

12 last initial transfer of a source or device covered by the certificate. This applies whether or not 

13 the licensee (certificate holder) is authorized to distribute other exempt products and may not be 

14 terminating their exempt distribution license. If this cessation of activity is associated with the 

15 termination of the license, the request for inactivation of registration should state the intent to 

16 terminate the license giving the specific license number. 

17 Note: A license is not terminated until the NRC takes action to terminate the license; therefore, 

18 an application for license termination does not relieve the licensee from its obligations to comply 

19 with NRC regulations and the terms and conditions of the license, until such time as the license 

20 is terminated in writing by NRC. 

21 All categories of exempt distribution licenses, except for 10 CFR 32.21 licenses, require that 

22 material transfer reports be filed after permanently discontinuing activities authorized by the 

23 license for the current calendar year within 30 days after ceasing distribution. If no transfers of 

24 byproduct or source material have taken place, the report must so indicate. The NRC will issue 

25 a termination notice upon request after receiving the final transfer report. However, after the 

26 license is terminated (or has expired), the former distribution licensee may no longer initially 

27 transfer for sale or distribution any remaining or new products. Termination of the distribution 

28 license does not relieve the licensee from any obligations or requirements related to terminating 

29 any associated possession license issued by the NRC or an Agreement State. This would 

30 include requirements related to residual contamination at the site. 

31 Exempt distribution licensees that intend to terminate their possession and use activities as well 

32 are also responsible for notifying the appropriate NRC or Agreement State authorities 

33 concerning the disposition of the possession license and all radioactive material, and for 

34 providing records of deposition, etc., to the NRC or the Agreement State. 

1 APPENDIX A 

2 UNITED STATES NUCLEAR REGULATORY COMMISSION FORM 313

A–1 

1 United States Nuclear Regulatory Commission Form 313 

2 Please use the most current version of this form, which may be found at: 

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

1 APPENDIX B 

2 RECORDS AND MATERIAL TRANSFER REPORTS 

B–1 

1 Records and Material Transfer Reports 

2 INTRODUCTION 

3 All distributors of products and materials for use under exemptions from licensing must submit 

4 annual material transfer reports and maintain the associated records of transfers, with the 

5 exception of licenses issued under Title 10 of the Code of Federal Regulations (10 CFR) 

6 10 CFR 32.21 for the manufacture, preparation, and commercial distribution of capsules 

7 containing carbon-14 urea for use under 10 CFR 30.21 (or the equivalent regulations of an 

8 Agreement State). 

9 REGULATIONS 

10 The reporting and recordkeeping requirements specific to exempt distribution are contained in 

11 10 CFR 32.12, 10 CFR 32.16, 10 CFR 32.20, 10 CFR 32.25(c), 10 CFR 32.29(c), 

12 10 CFR 32.32(c), and 10 CFR 40.53(c). 

13 REQUIREMENTS 

14 Whether a licensee is licensed under 10 CFR 32.11, 10 CFR 32.14, 10 CFR 32.18, 

15 10 CFR 32.22, 10 CFR 32.26, 10 CFR 32.30, or 10 CFR 40.52, it must: 

16  Keep records of all transfers until 1 year after the transfer has been reported to the 

17 U.S. Nuclear Regulatory Commission (NRC). 

18  Annually submit a material transfer report covering the preceding calendar year, by 

19 January 31 of each year. A report is also required from licensees who permanently 

20 discontinue activities authorized by the license within 30 days after ceasing distribution 

21 and which covers transfers made during the current calendar year. 

22 If a licensee is licensed under any of these sections, the report must: 

23 1. Clearly identify the specific licensee submitting the report and include the license 

24 number of the specific licensee. 

25 2. Indicate the specific exemption under which materials/products/devices have been 

26 transferred for use. In the case of 10 CFR 30.15 and 10 CFR 40.13(c), this must include 

27 the specific paragraph number in NRC regulations, for example, 10 CFR 30.15(a)(8) for 

28 electron tubes, and 10 CFR 40.13(c)(1)(iii) for welding rods. The report must include all 

29 transfers nationally, including those for use under the equivalent exemptions in 

30 Agreement State regulations. Only the designation of the NRC regulation covering the 

31 product must be indicated. 

32 3. Indicate if no transfers of byproduct or source material were made for use under the 

33 applicable exemption during the reporting period. [In other words: Even if no distribution 

34 has occurred in a particular year, a report is still required.] 

35 4. Address to the Director of the Office of Nuclear Material Safety and Safeguards (NMSS), 

36 including in the address: ATTN: Document Control Desk/Exempt Distribution. This 

37 address should appear on both the envelope and the enclosed report. 
B–2 

1 In addition to items 1 through 4 above, the report must include certain information on the 

2 materials/products/devices transferred to other persons for use under the exemption. This 

3 required information varies somewhat based on the type of exemption as described in the 

4 next section: 

5 In reporting byproduct material transferred under 10 CFR 30.15, 10 CFR 30.19, 10 CFR 30.20, 

6 or 10 CFR 30.22, and source material transferred under 10 CFR 40.13(c) (and equivalent 

7 Agreement State provisions), the licensee must report 

8 1. a description or identification of the type of each product/device (and the model 

9 number(s), if applicable) 

10 2. for each radionuclide in each type of product/device (and each model number, if 

11 applicable), the total quantity of the radionuclide (see note below for products containing 

12 source material [10 CFR 40.13(c)] 

13 3. the number of units of each type of product/device transferred during the reporting 

14 period (by model number, if applicable) 

15 “If applicable,” means that the reports should include the numbers of units and quantities 

16 of material distributed by model number if the distributor uses model numbers to 

17 distinguish its products. Data from similar models may be combined when there are no 

18 significant radiological differences, such as when a series of models have only aesthetic 

19 differences. 

20 Note: For products containing source material [distributed for use under 

21 10 CFR 40.13(c)], instead of providing specific radionuclides (Item 2 above), the type of 

22 source material must be provided. This means simply uranium, depleted uranium, or 

23 thorium. However, this information is to be provided for each type of product and each 

24 model number, if applicable. (See also Q. 25 in Appendix F.) 

25 In reporting byproduct material transferred for use under 10 CFR 30.18 (and equivalent 

26 Agreement State provisions), the licensee must report 

27 For each radionuclide in each physical form (e.g., solid, liquid, gas), the total quantity of 

28 each radionuclide and the physical form. 

29 Note: Although a distributor of exempt quantity sealed sources may want to report by 

30 model number, it is important that the report includes the total amount of each 

31 radionuclide distributed in each physical form. Terms such as “solid,” “liquid,” or “gas” 

32 are appropriate to use for reporting the physical form of exempt quantities; however, 

33 other descriptive terms such as “metal” or “powder” are also acceptable. If a licensee 

34 has documentation that more quickly and easily provides essentially the same 

35 information and allows the NRC to determine the physical form of the distributed 

36 material, a licensee may report using its own terminology instead (e.g., “solution” instead 

37 of “liquid” or “sealed source” instead of “solid”). However, terms that are ambiguous with 

38 respect to physical form (e.g., “calibration standard” or “radio-labeled research 

39 compounds”) are not acceptable for reporting exempt quantity distribution. 

40 In reporting byproduct material transferred for use under 10 CFR 30.14 (and equivalent 

41 Agreement State provisions), the licensee must report 
B–3 

1 1. the type and quantity of each product or material into which byproduct material has been 

2 introduced during the reporting period 

3 2. the type and quantity of radionuclide introduced into each product or material 

4 3. the initial concentrations of the radionuclide in the product or material at time of transfer 

5 of the byproduct material by the licensee 

6 4. the name and address of the person who owned or possessed the product or material, 

7 into which byproduct material has been introduced, at the time of introduction 

8 This last item is required because a radionuclide tracer company, for example, may hold 

9 the license under 10 CFR 32.11 and may be introducing byproduct material as a tracer 

10 into varying products being distributed by others from different locations. Paragraph (c) 

11 of 10 CFR 30.14 exempts the manufacturer, processor, or producer of the product or 

12 material to the extent that this person transfers byproduct material contained in a product 

13 or material in concentrations not in excess of those specified in 10 CFR 30.70 and 

14 introduced into the product or material by the licensee holding a specific license issued 

15 by the NRC authorizing such introduction. 

Table B-1. Quick Reference Table for Annual Transfer Reports 

Licensed under 10 CFR 32.11 32.14 32.18 32.22 32.26 32.30 40.52

Identification of specific licensee and 

license number 

X X X X X X X 

Specific exemption distributed under X X X X X X X 

Description or identification of the type of 

each product/device and model number, if 

applicable 

X X X X X X 

Quantity of each radionuclide (or uranium 

or thorium) in each type of product/device 

and model number, if applicable, 

distributed nationally 

X X X X X X 

Quantity of each type of product/device 

transferred nationally during the reporting 

period 

X X X X X X 

Type and quantity of each product or 

material into which byproduct material has 

been introduced during the reporting 

period. 

X 

The type and quantity of radionuclide 

introduced into each product or material. 

X 

Initial concentration of the radionuclide in 

the product/device at time of transfer 

X 

Name and address of the person who 

owned/possessed the product/material at 

the time byproduct material was 

introduced 

X 

Quantity of each radionuclide in each 

physical form transferred nationally during 

reporting period 

 X 

1 APPENDIX C 

2 INFORMATION NEEDED TO SUPPORT AN APPLICATION FOR A LICENSE 

3 UNDER 10 CFR 32.11 TO DISTRIBUTE IRRADIATED GEMSTONES TO 

4 PERSONS EXEMPT FROM LICENSING

C–1 

1 Information Needed to Support an Application for a License Under 

2 10 CFR 32.11 to Distribute Irradiated Gemstones to Persons Exempt 

3 from Licensing 

4 Introduction 

5 Exposing gemstones to radiation is a method of enhancing and deepening the gemstone color. 

6 The bombardment of radiation hitting the gemstone deposits energy that creates color centers. 

7 For example, radiation can cause a naturally clear topaz to turn blue. Other gemstones are 

8 irradiated with other color enhancements. Gemstone color enhancement using radiation can be 

9 performed using a nuclear reactor (neutron bombardment), an accelerator (most commonly 

10 electron-particle beam exposure), or a cobalt irradiator (gamma rays). Color enhancement by 

11 irradiation is currently widely used on gemstones such as topaz, tourmaline, quartz, beryl, 

12 zircon, diamond, and labradorite. 

13 Those who wish to distribute irradiated gemstones in the United States need: (1) a possession 

14 license issued either by the U.S. Nuclear Regulatory Commission (NRC) or an Agreement 

15 State, depending on the geographic location of the distributor, and (2) an exempt distribution 

16 license issued only by the NRC. In the case of domestic reactors, the NRC has jurisdiction 

17 everywhere in the United States. The authority for possession of byproduct material under 

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

19 Applicability to Domestic Licensing of Byproduct Material,” is incorporated into the 

20 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,” license. 

21 The possession license will authorize the irradiator or importer to possess the radioactive 

22 material contained in irradiated gemstones. If irradiation takes place in a foreign country, 

23 importation of the radioactive gemstones into the United States is authorized by the general 

24 license for import in 10 CFR 110.27(a). (Refer to NUREG-1556, Volume 16 “Program-Specific 

25 Guidance About Licenses Authorizing Distribution to General Licensees,” Section 5.5, “Foreign 

26 Vendors.”) The distribution license will authorize the irradiator or importer to transfer (i.e., sell) 

27 irradiated gemstones to persons exempt from licensing (e.g., wholesalers, manufacturing 

28 jewelers, retail jewelers). Only the initial distributor is required to have a license. 

29 This appendix outlines the information needed to support applications for licenses to be issued 

30 under 10 CFR 32.11, when the product is gemstones. 

31 The information that must be included in the application can be categorized as follows: 

32 • basic information (e.g., name of applicant) 

33 • information regarding proposed processes 

34 • information specifically identified in the regulations (e.g., 10 CFR 30.33, 10 CFR 32.11) 

35 • Information on the Quality Assurance (QA) Program, including instrumentation, counting, 

36 sampling, and quality control (QC) 
C–2 

1 • information needed to support a request for an exemption from that portion of 

2 10 CFR 32.11(c) that prohibits use of exempt concentrations in products designed for 

3 application to a human being, including a dose assessment 

4 • fee information and signature 

5 Detailed information is needed to ensure a clear understanding of the scope and intent of the 

6 applicant’s proposed activities. 

7 Content of Application 

8 A. Basic Information 

9 1. Specify the location(s) 

10 a. at which gemstones will be irradiated, or, if imported, where they will be 

11 received and possessed 

12 b. from which irradiated gemstones will be distributed to persons exempt 

13 from licensing 

14 c. at which records pertaining to possession and distribution of irradiated 

15 gemstones will be maintained, if different 

16 2. For gemstones that are to be neutron-irradiated in a nuclear reactor in the 

17 United States 

18 a. Specify the docket number of the NRC reactor license. 

19 b. If the reactor is licensed under 10 CFR 50.21, “Class 104 licenses; for 

20 medical therapy and research and development facilities,” provide 

21 information to demonstrate that less “than 50 percent of the annual cost 

22 of owning and operating the facility is devoted to the production of 

23 materials, products, or energy for sale or commercial distribution, or to the 

24 sale of services, other than research and development or education or 

25 training.” Note: This information will be reviewed with the assistance of 

26 the staff of the Office of Nuclear Reactor Regulation. If a license is 

27 issued under 10 CFR 32.11, it will require annual submission of 

28 similar information. 

29 3. For gemstones that are to be accelerator-irradiated in the United States 

30 a. Identify the type of accelerator. 

31 b. Operation of accelerators is regulated by the States, regardless of 

32 whether they are located in an Agreement State or a non-Agreement 

33 State. 

34 4. For gemstones that are to be imported 

35 Indicate what country they will be obtained from and whether irradiation facilities 

36 are owned by the applicant or others. 
C–3 

1 5. Possession licenses for the purpose of distribution: 

2 As noted above, those who wish to distribute irradiated gemstones in the 

3 United States need a possession license issued either by the NRC or an 

4 Agreement State, depending on the geographic location of the distributor. 

5 Evidence of the possession license would be provided in order to obtain the 

6 distribution license. 

7 NUREG-1556, Volume 12, “Program-Specific Guidance About Possession 

8 Licenses for Manufacturing and Distribution,” provides guidance to applicants in 

9 non-Agreement States in preparing a license application for certain license types, 

10 including possession for distribution. Agreement States have requirements 

11 similar to those of the NRC for the possession licenses for manufacturing 

12 and distribution. 

13 NUREG-1556, Volume 21 “Program-Specific Guidance About Possession 

14 Licenses for Production of Radioactive Material Using an Accelerator,” provides 

15 guidance to applicants in non-Agreement States that produce radioactive 

16 materials using an accelerator, including preparation of a license application, 

17 NRC criteria for evaluating the license application, and the standard 

18 requirements and guidance for the possession and distribution of radioactive 

19 material that is produced by an accelerator located at the applicant’s facility. 

20 Agreement States have requirements similar to those of the NRC for the 

21 possession and distribution of accelerator-produced radioactive material. 

22 B. Information regarding proposed processes 

23 1. Describe the material to be irradiated, including: 

24 a. The type(s) of gemstone (e.g., topaz, diamond) 

25 b. The geologic origin. For some types of gemstones, knowledge of their 

26 geologic origin may provide information about the types of impurities 

27 they contain. 

28 c. Impurities (trace elements). Knowledge of impurities (trace elements) 

29 prior to irradiation may facilitate the identification of radionuclides 

30 produced by activation. 

31 d. The size range. Larger gemstones may require longer irradiation times 

32 than smaller gemstones to achieve the desired effect and may, therefore, 

33 induce a higher level of radioactivity. 

34 e. The extent to which gemstones have been processed before irradiation 

35 (e.g., cut and polished). Note: Only finished gemstones that do not 

36 require cutting, grinding, or polishing after irradiation will be authorized for 

37 distribution to persons exempt from licensing. 
C–4 

1 2. Describe how gemstones are handled, preirradiation, to ensure grouping 

2 according to geologic origin of gemstones and type(s) of irradiation or treatment 

3 to which gems have been exposed (significant variations in induced 

4 radionuclides will result from differences in gemstones’ origin and type(s) of 

5 irradiation or treatment received). 

6 3. Describe preirradiation cleaning to prevent/minimize activation of 

7 surface contaminants. 

8 4. Describe the irradiation process, including: 

9 a. The type(s) and sequence of irradiation (e.g., neutron-, accelerator-, or 

10 gamma-irradiation only; neutron followed by accelerator or gamma 

11 irradiation) or other treatment (e.g., heat) to which gemstones have been 

12 exposed before they are to be distributed. 

13 b. Where and by whom each irradiation or other treatment is to be 

14 performed. Identify U.S. reactors and accelerators by name and location; 

15 identify foreign reactors by name and country. 

16 c. Identification of the energy or energies used for each type of irradiation. 

17 5. Describe post-irradiation handling of gemstones, including: 

18 a. Procedures used to ensure that each irradiated gemstone is free of 

19 removable contamination, including a description of sampling, monitoring, 

20 counting, and statistical techniques used, specification of the criteria used 

21 to determine when gemstones are essentially “free of removable 

22 contamination,” and a description of what will happen to gemstones 

23 exceeding the specified criteria. Note: cleaning of surface contaminants 

24 after irradiation may result in radioactive waste. 

25 b. The processing of irradiated gemstones at the applicant’s facility and the 

26 sequence of these activities (e.g., counting of gemstones and storage for 

27 physical decay; mounting in rings, pendants, or other settings). 

28 c. The categories of unlicensed organizations to which irradiated gemstones 

29 will be transferred (e.g., wholesaler; manufacturing jeweler; retail jeweler; 

30 individual consumer). 

31 d. What will be done with gemstones whose concentrations exceed the 

32 criteria specified in response to Item C.2.e. below. (Alternatives include 

33 hold in storage for physical decay, transferring to a person specifically 

34 licensed to receive them, or disposal as radioactive waste in accordance 

35 with the requirements of 10 CFR Part 20 or equivalent regulations of an 

36 Agreement State.) 
C–5 

1 6. Describe the procedures used in analysis of the radioactivity in gemstones, 

2 including: 

3 a. Identification of all radionuclides with physical half-lives greater than 

4 2 hours (regardless of method of production) induced in gemstones and 

5 classification of each as either a “major” or “minor” radionuclide, 

6 depending on its contribution to total activity in gemstones to be 

7 distributed to persons who are exempt from licensing or to the potential 

8 contribution to doses. 

9 b. How the information provided in response to the previous item was 

10 obtained and how the NRC can be assured that this information is 

11 representative of gemstones distributed in the future. 

12 7. Describe: 

13 a. Anticipated production (e.g., the estimated maximum number and mass 

14 (in grams) of gemstones to be irradiated at one time and the estimated 

15 number of batches per year) or, if importing, the anticipated quantities 

16 expected to be imported into the United States. 

17 b. The possession limit to be requested in possession license can be 

18 determined by multiplying the maximum number of gemstones to be 

19 possessed at one time by the maximum total activity anticipated in any 

20 one gemstone. 

21 C. Information Required by 10 CFR 32.11 

22 1. Paragraph (a) of 10 CFR 32.11 requires that the general requirements of 

23 10 CFR 30.33 be satisfied. To comply with this requirement (or equivalent 

24 requirements of Agreement States), the applicant will 

25 a. Explain how the facilities and equipment proposed in the application are 

26 adequate to protect health and minimize danger to life or property with 

27 respect to activities to be conducted under this license. Specifically, 

28 explain how irradiated gemstones will be stored and secured against 

29 unauthorized removal or, when not stored and secured, will be tended 

30 under the constant surveillance and immediate control of a 

31 knowledgeable, responsible person on the licensee’s staff. 

32 b. Identify by name the individual(s) who will be responsible for handling, 

33 irradiating, storing, counting, evaluating, and controlling the release of 

34 irradiated gemstones; correlate individuals’ names with their 

35 responsibilities; and describe the training and experience of each of these 

36 individuals that assures protection of the public health and safety. 

37 2. Paragraph (b) of 10 CFR 32.11 requires that certain information be provided. If 

38 information on one or more points has already been provided, reference the 

39 previous response by section and item number or provide a complete response. 

40 To comply with 10 CFR 32.11(b), the applicant will describe: 
C–6 

1 a. The product or material into which byproduct material will be introduced 

2 (see response to Item B.1.a above) 

3 b. The intended use of the byproduct material and the product or material 

4 into which it is introduced. 

5 c. The method of introduction (see response to Item B.4 above). 

6 d. Initial concentration of byproduct material in the product or material. 

7 e. Maximum concentration of the radioisotopes in the product or material at 

8 the time of transfer to persons exempt from licensing. 

9 f. Control methods to assure that no more than the specified maximum 

10 concentration is in the product at time of transfer. 

11 g. Estimated time interval between introduction and transfer of the product 

12 or material (i.e., between completion of all types of irradiation and transfer 

13 to unlicensed persons). 

14 3. Paragraph (c) of 10 CFR 32.11 requires applicants to provide reasonable 

15 assurance of the following: 

16 a. Concentrations of byproduct material at time of transfer will not exceed 

17 the concentrations in 10 CFR 30.70 (“Schedule A”). 

18 Notes: 

19 (i) the limit for a single radionuclide is given in 10 CFR 30.70; the limits for 

20 multiple radionuclides are calculated using the “sum of the ratios” method 

21 described in Note 2 of 10 CFR 30.70. 

22 (ii) for isotopes not specifically listed in 10 CFR 30.70, the release 

23 concentration can be calculated using the formula: 

24 C = ALI / (3000 × 365) 

25 where 3,000 ml is the daily water intake for reference man, 365 is days 

26 per year and ALI is the annual limit of intake for ingestion. The ALIs for 

27 most isotopes, including those not specifically listed in Schedule A, are 

28 provided in 10 CFR Part 20, Appendix B, “Annual Limits on Intake (ALIs) 

29 and Derived Air Concentrations (DACs) of Radionuclides for Occupational 

30 Exposure; Effluent Concentrations; Concentrations for Release to 

31 Sewerage,” Table 1, Column 1. 

32 (iii) Actual doses from gemstones will normally result from external 

33 exposures. However, the exempt concentration limits were based on the 

34 potential for intakes. This approach for establishing limits for 

35 radionuclides not listed in the table is similar to, but more conservative 

36 than, that used to establish the exempt concentration provisions. 
C–7 

1 b. Reconcentration of the byproduct material in concentrations exceeding 

2 those specified in 10 CFR 30.70 is not likely (e.g., in the case of 

3 gemstones, one could consider that neutron-irradiation followed by 

4 accelerator-irradiation could increase the induced activity and thus be 

5 considered “reconcentration;” thus, it should be unlikely that additional 

6 treatment causing activation will occur after control procedures to ensure 

7 concentrations meet regulatory limits). 

8 c. The use of concentrations lower than those specified in response to Item 

9 C.2.e is not feasible (i.e., provide assurance as to why maximum values 

10 for a single radionuclide should not be lower; why maximum values for 

11 multiple radionuclides should not be lower than one when calculating the 

12 “sum of the ratios”). 

13 d. The product or material is not likely to be incorporated into any food, 

14 beverage, cosmetic, drug, or other commodity or product designed for 

15 ingestion or inhalation by a human being. This paragraph also addresses 

16 application to the human body; the need for and way of obtaining an 

17 exemption from that aspect is discussed in paragraph E. 

18 D. Information on Quality Assurance (QA) Program 

19 The QA program for a 10 CFR 32.11 licensee concerns primarily the control methods to 

20 assure that no more than the specified concentration is introduced into the product or 

21 material, and that the concentration of the radioisotopes in the product or material at the 

22 time of transfer do not exceed the applicable limits. If they do not wish to do the QA 

23 themselves, licensees may contract this work to another organization. In this case, the 

24 contract organization’s identity, mailing address, location of work for the importer, etc., 

25 must be provided and all responses to the items listed below must clearly explain who 

26 (licensee or contract organization) will perform each function. When a contract 

27 organization is employed to assist a licensee, the licensee will still be responsible for 

28 proper performance of the QA program and must conduct appropriate audits and 

29 reviews to ensure that the QA program is being performed as described in the licensee’s 

30 correspondence with the NRC. 

31 1. Describe the radiation detection equipment and shielding associated with it that 

32 are to be used to identify and quantify the radioactivity induced in gemstones. 

33 2. Specify procedures used to calibrate such radiation detection equipment, 

34 including the frequency of calibration, the calibration standard used (the 

35 radionuclide, its activity, and its traceability). 

36 3. Describe counting procedures and how external measurements are converted to 

37 concentration values in terms of microcuries per gram. Your description should 

38 include, but is not limited to 

39 a. selection of samples 

40 b. maximum and minimum sample size (in terms of number of stones 

41 and mass) 
C–8 

1 c. counting efficiency 

2 d. counting times 

3 e. counting geometry 

4 f. time of counting (in relation to completion of irradiation and transfer to 

5 unlicensed persons) 

6 g. minimum detectable activities 

7 h. statistical methods for analyzing data, calculating background and 

8 minimum detectable activities, and determining confidence levels 

9 i. procedures for minimizing “false negatives” (i.e., failure to identify 

10 individual gemstones with radionuclide concentrations greater than those 

11 specified in response to Item C.2.e.) 

12 j. sample calculations 

13 4. At a minimum, your procedures must be sufficient to ensure that 

14 a. After each irradiation, measurements performed on gemstones are 

15 adequate to identify all induced radionuclides. 

16 b. Before release to unlicensed persons, gemstones are analyzed to 

17 ensure that the concentrations listed in 10 CFR 30.70 are not exceeded; 

18 because multiple radionuclides will normally be present, the “sum of the 

19 ratios” does not exceed unity. In lieu of use of the “sum of the ratios,” it 

20 would be acceptable to ensure that 

21 i. induced beta and/or gamma emitting byproduct material has a 

22 physical half-life less than 3 years 

23 ii. the total concentration of byproduct material does not exceed 

1 × 10-6 24 μCi/gm 

25 c. If the activity is not quantitatively measured in each gemstone individually 

26 (i.e., if quantitative measurements are made on groups of gemstones), 

27 there is only 1 chance in 1,000 that an outlier gemstone will contain more 

28 than twice the appropriate 10 CFR 30.70 maximum value (for single or 

29 multiple radionuclides). 

30 5. Specify who will be responsible for the QA program and describe this individual's 

31 training and experience in detection and analysis of low levels of radioactivity. If 

32 this individual was identified in response to Item C.1.b, it is not necessary to 

33 repeat the individual’s qualifications, provided that the response to Item C.1.b 

34 includes a clear description of the person’s training and experience in low-level 

35 counting techniques. 
C–9 

1 6. Describe the QA program used to ensure reliable data, including 

2 a. The criteria, frequency, and procedures used to perform response tests 

3 on the counting system(s). Note: Response tests must be performed at 

4 installation and daily when equipment is in use. These tests are intended 

5 to ensure the accuracy and precision of the data obtained in the 

6 measurement process. Such tests are usually performed using a 

7 traceable long-lived source such as cesium-137 (30-year half-life), 

8 measuring its activity and comparing the measured value to the 

9 expected value. 

10 b. The methods and frequency of introducing “spiked” samples into 

11 the routine counting process to assure identification of gemstones 

12 with concentrations in excess of your criteria (i.e., response to 

13 Item C.2.e above). 

14 7. Provide a commitment that, during the term of the license, the applicant will 

15 comply promptly with requests from the NRC designed to monitor counting 

16 techniques. The general nature of these requests is outlined below: 

17 a. Upon request, the applicant will provide samples of irradiated gemstones 

18 to the NRC for independent verification of radionuclide identity and 

19 concentration. The NRC’s request will be in writing, signed by the 

20 appropriate Regional Administrator or the Director, Office of Nuclear 

21 Material Safety and Safeguards (NMSS). The request will specify who 

22 (i.e., NRC representative, NRC contractor, or applicant) will select the 

23 samples for independent verification. After analysis, samples will be 

24 returned promptly to the applicant. 

25 b. Upon request, the applicant will analyze qualitatively, quantitatively, or 

26 both, gemstones or groups of gemstones provided by the NRC or its 

27 contractor. The request will be in writing, signed by the appropriate 

28 Regional Administrator or Director, NMSS will specify the type of analysis 

29 requested and techniques to be followed; and will provide instructions for 

30 reporting results and for returning gemstones. 

31 E. Information Needed to Support Request for Exemption from a Portion of 

32 10 CFR 32.11(c). Note that 10 CFR 32.11(c), among other things, prohibits the 

33 incorporation of exempt concentrations into products or materials designed for 

34 application to human beings. Irradiated gemstones with induced activity could be 

35 expected to be set in jewelry and worn by consumers (i.e., “applied to human beings”). 

36 In order to grant licenses authorizing distribution of these gemstones to unlicensed 

37 persons, it will be necessary to grant a limited exemption from the requirements of 

38 10 CFR 32.11(c). Regulations in 10 CFR 30.11, “Specific Exemptions,” provides for the 

39 granting of exemptions. 

40 1. To fulfill the requirements of 10 CFR 30.11(a), the applicant must make a specific 

41 request for an exemption from that portion of 10 CFR 32.11(c) that prohibits 

42 incorporation of exempt concentrations in products or materials designed for 

43 application to a human being. The request may be worded as follows: “Because 

44 the NRC considers gemstones to be products intended for application to human 
C–10 

1 beings, an exemption from this portion of the requirements in 10 CFR 32.11(c) 

2 is requested.” 

3 2. Using a worst-case scenario, calculate the annual radiation dose to 

4 unlicensed persons. 

a. Skin Dose: Calculate the dose averaged over 10 cm2 5 of skin at contact 

6 and at 4 cm from jewelry (e.g., pendant) containing irradiated gemstones 

7 that is worn continuously (24 hours per day, 365 days per year). 

8 b. Effective Dose: Also estimate the effective dose (the tissue-weighted 

9 sum of the equivalent doses in all specified tissues and organs of the 

10 body) if there are significant gamma emissions. Assume that these 

11 gemstones contain those radionuclides (identified in your response to 

12 Item B.4) with the longest physical half-lives and highest energy 

13 emissions at the maximum concentrations (identified in your response to 

14 Item C.2.e.) you propose to release to unlicensed persons. Dose 

15 calculations must consider all types of emissions (e.g., beta, gamma, 

16 bremstrahlung) from the identified radionuclides. 

17 3. Provide similar calculations and assessments for gemstones that are outliers 

18 (i.e., gemstones with concentrations as much as twice the criteria you plan to 

19 use). These calculations are necessary in order to account for the 1 chance 

20 in 1,000 that an outlier gem will contain more than twice the appropriate 

21 10 CFR 30.70 maximum value, as discussed in Item D.4.c. 

22 4. Submit copies of proposed labels or other information, such as a brochure, at the 

23 point-of-sale of irradiated gemstones that indicates the presence of low-levels of 

24 radioactivity. The purpose of such a label or brochure is to enable consumers to 

25 make an informed decision at time of purchase. 
1 APPENDIX D 

2 ADDITIONAL GUIDANCE FOR SELF-LUMINOUS PRODUCTS 

D–1 

1 Additional Guidance for Self-Luminous Products 

2 1. PURPOSE 

3 To provide additional guidance on the requirements for self-luminous products, which may also 

4 serve as an example of the appropriate level of detail in applications under other provisions. 

5 2. APPLICABILITY 

6 Self-luminous products exempt under Title 10 of the Code of Federal Regulations (10 CFR) 

7 10 CFR 30.19, with particular emphasis on gun sights containing gaseous tritium light sources. 

8 3. REQUIREMENTS 

9 An applicant for a license to manufacture, process, or distribute self-luminous products 

10 containing tritium, krypton-85, or promethium-147 for the purpose of producing light shall submit 

11 the information required in 10 CFR 32.22, and this information must demonstrate that the 

12 product will meet the safety criteria in 10 CFR 32.23 and 10 CFR 32.24. 

13 3.1 10 CFR 32.22(a)(2) Information Requirements:

14 (1) A description of the product and its intended use or uses. 

15 Means of identification of the product may include its trade name and model number, 

16 patent number or design patent number (if patented), registered copyrights, trademarks, 

17 pictures of the product. 

18 Intended use should include descriptions of types of users, locations of use, possibility of 

19 use in other products, circumstances of normal use, circumstances of the most severe 

20 conditions, and potential circumstances of use that might significantly affect doses when 

21 diverted from intended use. The description should be sufficient to indicate that the end 

22 use of the product can be reasonably foreseen. 

23 (2) The type and quantity of byproduct material in each unit. 

24 Many factors affect the choice of the type of byproduct material and the quantity of 

25 activity to be used in a product. A self-luminous product must have properties that are 

26 necessary and sufficient for its use. Among these are, for example, adequate light 

27 output, adequate lifetime of light source, convenient size and shape. Sometimes the 

28 byproduct material is provided in a light source of standard design, in which case the 

29 applicant should still determine the minimum activity that will produce the properties 

30 desired for the product. 

31 (3) Chemical and physical form of the byproduct material in the product and changes 

32 in chemical and physical form that may occur during the useful life of the product. 

33 A. Chemical and physical form 

34 The specification of the chemical and physical form should include both the 

35 radiochemical purity of the byproduct material and the chemical purity of the 
D–2 

1 radioactive, self-luminous compound to the extent that the estimation of doses 

2 is affected. 

3 Tritium 

4 Tritium gas always contains some helium-3 daughter products and may contain 

5 oxygen, water vapor, and tritiated compounds. Tritiated self-luminous paint 

6 contains a variety of compounds (e.g., pigment, vehicle, binder). Tritiated plastic 

7 should be described by the trade name of the self-luminous compound, the 

8 specific activity of the plastic, and the principal tritiated compounds in the plastic. 

9 Krypton-85 

10 Krypton-85 is likely to be incorporated into a product in the elemental form as a 

11 noble gas. Krypton-85 gas likely contains other gases and water vapor. 

12 Promethium-147 

13 Promethium-147 is likely to be applied or incorporated in the form of a solid 

14 promethium compound bound in an inert (ceramic) medium, which in turn is 

15 intimately mixed with a luminising agent, binder, vehicle, etc. to form a paint. 

16 Please provide the trade name of the inert medium and paint, the specific activity 

17 of the paint, and the principal promethium-147 compound in the paint. 

18 B. Changes in chemical and physical form 

19 Changes in chemical and physical form are those that occur during the useful life 

20 of the product that would significantly affect the estimates of doses that would 

21 result from the product. 

22 Tritium 

23 The changes in chemical and physical form of tritium are complex during the 

24 useful life of a self-luminous product containing gaseous tritium. Tritium gas may 

25 be converted to tritium oxide or tritium-hydrogen oxide vapor if oxygen or water 

26 vapor is present in a light source. Tritium diffusing through the glass wall of a 

27 light source may desorb from the outside of the glass as tritium oxide and may be 

28 changed to tritiated organic compounds, when absorbed through the skin. 

29 Tritium luminous paint may evolve both tritium oxide and tritiated organic 

30 compounds. Tritiated plastic may have, by isotopic exchange, tritiated water 

31 molecules on its surface. The chemical form of the tritium at the time of 

32 exposure is very important with respect to the dose calculations. 

33 Krypton-85 

34 Krypton-85 is inert and so unlikely to undergo chemical or physical change during 

35 the useful life of the product that would significantly affect estimates of doses.
D–3 

1 Promethium-147 

2 During the useful life of the product, promethium-147 will decay to 

3 samarium-147, an alpha emitter. The activity of samarium-147 formed would be 

4 quite small. Compounds containing promethium-147 that are incorporated into 

5 self-luminous products are not likely to undergo chemical or physical changes 

6 that would significantly affect estimates of doses. 

7 (4) Solubility in water and body fluids of the identified forms of byproduct material, 

8 including any forms that arose as a result of prototype testing. 

9 The byproduct material may change its chemical or physical form during the useful life 

10 and during the disposal of the product; thus, solubility may change. 

11 Tritium may be incorporated as a gas, but may be partly converted to tritium oxide. 

12 Thus, the solubility of tritium gas and tritium oxide in water and bodily fluids should be 

13 given. The solubility of tritium gas into water and bodily tissues is very small; while that 

14 of tritiated water is high. The most important information for the dose assessment is the 

15 fraction of tritium that is oxidized. 

16 Krypton-85 will likely remain a gas. Its solubility in water and bodily fluids is a function 

17 of the partial pressure of krypton-85 above the fluid and the temperature of the 

18 gas-fluid system. 

19 Promethium-147 may be bound as a relatively insoluble compound in a relatively inert 

20 medium. The migration of promethium-147 from the inert medium into water and bodily 

21 fluids should be determined after being subjected during prototype testing to various 

22 stresses, such as crushing, thermal shock, etc. 

23 (5) Details of construction and design of the product as related to containment and 

24 shielding of the byproduct material and other safety features under normal and 

25 severe conditions of handling, storage, use, and disposal of the product. 

26 Materials of construction, thicknesses, methods of bonding or sealing (welding, 

27 cementing, brazing) should be specified in detail. Blueprints, cross-sectional drawings to 

28 scale, and specification sheets will be helpful. 

29 The overall protection factors by the containment and by the shielding should be 

30 measured, if possible, or estimated. For instance, the diffusion of the tritium through the 

31 glass walls of the product’s light source should be measured. The reduction in gamma 

32 radiation levels from krypton-85 light sources should be measured, and the biological 

33 availability of promethium-147 should be measured. Other safety features should 

34 be discussed. 

35 (6) Maximum external radiation levels at 5 and 25 centimeters from any external 

36 surface of the product, averaged over an area not to exceed 10 square 

37 centimeters, and the method of measurement. 

38 All of the essential parameters of the applicant’s measurements must be given. These 

39 should include the make and model number of the instrument used; the method of 

40 calibrating the instrument; the window thickness and other absorbers between the 
D–4 

1 source and the sensitive volume of the detector; factors used to correct for scatter, 

2 geometry, etc.; the actual distance from the source to the sensitive volume of the 

3 detector; the radiation measured (gamma, beta, bremsstrahlung); the units actually 

4 measured; and the factors, including Quality Factors or other modifying factors used to 

5 estimate the reported external radiation levels. 

6 (7) Degree of access of human beings to the product during normal handling 

7 and use. 

8 Some products are designed to be worn, held, or otherwise handled during use. Others 

9 are mounted on surfaces such as walls, ceiling, panels, and equipment, and possibly 

10 other items, and are only handled during cleaning or repair. The degree of access can 

11 be summarized by estimating the percent of time that the product will be worn, held, 

12 handled, cleaned, or repaired. A rather precise estimate of the time a product may 

13 spend undergoing repair is important for those light sources having high surface 

14 radiation levels in the unshielded condition. The minimum, average, and maximum 

15 distances from the points of interest to the product during handling, use, and disposal 

16 can be measured and/or estimated. 

17 (8) Total quantity of byproduct material expected to be distributed in the 

18 product annually. 

19 The quantity would be the number of individual units multiplied by the quantity of activity 

20 per unit you expect to sell each year. 

21 (9) The expected useful life of the product. 

22 Most self-luminous products are useful only as long as they produce a usable quantity of 

23 light. Their useful lives are functions of the mechanical loss of byproduct material from 

24 the product, the radioactive decay of the byproduct material, the deterioration of the 

25 phosphor, and the accidental breakage of the product. Some continue to be useful even 

26 when they can no longer produce a usable quantity of light. The applicant can estimate 

27 the likelihood that the product would be discarded when the usable quantity of light 

28 falls off. 

29 (10) The proposed method of labeling or marking each unit with identification of the 

30 manufacturer or initial transferor of the product and the byproduct material in 

31 the product. 

32 The product is to be labeled with H-3, or Kr-85, or Pm-147, as appropriate, and the 

33 name, registered trademark, or license number of the manufacturer, processor, 

34 producer, or initial transferor of the product. 

35 The product may be engraved or otherwise labeled using paint, durable metal foil label, 

36 etc. However, the applicant must provide adequate information that the labeling remains 

37 legible after being subjected to prototype testing. The labeling or marking with the 

38 identification of the byproduct material would best be on the transparent containment 

39 layer of the light source; thus, the source would illuminate the label or marking. Labels 

40 should not be on inconspicuous areas, if possible. Products that are quite small may not 

41 be able to accept the required labeling or marking. The location, size, and other aspects 
D–5 

1 of labeling and marking will be compromises between best informing the user and what 

2 can be accommodated on the product. Supplying sample labels would be helpful. 

3 (11) Procedures for prototype testing of the product to demonstrate the effectiveness 

4 of the containment, shielding, and other safety features under both normal and 

5 severe conditions of handling, storage, use, and disposal of the product. 

6 Under prior items, information has been included on the containment, shielding, and 

7 other safety features, as well as normal and most severe conditions of handling, storage, 

8 use, and disposal. These factors are to be considered in the design of the prototype 

9 testing. It is crucial to select reproducible laboratory test conditions that equal or exceed 

10 the stresses, environments, etc., that the product will undergo after transfer to exempted 

11 persons. Of the events that can happen, the ones chosen for laboratory testing should 

12 be those most likely to breach the containment, shielding, and other safety features 

13 essential to keeping the dose limits within the limits in the safety criteria. 

14 The prototype testing procedures should be described in sufficient detail to permit an 

15 independent testing organization to duplicate the tests. 

16 Description of prototype testing should address the following: (a) reason for the test; 

17 (b) the characteristic being tested; (c) the stresses applied during the test; (d) the special 

18 equipment used to apply the stresses; (e) the intensity of the stresses applied; (f) the 

19 duration of the stresses applied; (g) relationship to other prototype tests; (h) methods of 

20 measurement of the response; and (i) criteria for rejection of the prototype. The 

21 elements of stress include, but are not limited to, acceleration, deceleration, pressure, 

22 temperature, time, solubility, friction, aging, and radiation. 

23 NUREG-1556, Volume 3, Rev. 2, “Applications for Sealed Source and Device Evaluation 

24 and Registration,” provides detailed information about prototype testing. 

25 (12) Results of the prototype testing of the product, including any change in the form 

26 of the byproduct material contained in the product, the extent to which the 

27 byproduct material may be released to the environment, any increase in external 

28 radiation levels, and any other changes in safety features. 

29 Describe the response of the prototypes to the tests and an interpretation of the 

30 response. The stresses and environmental conditions of the prototype tests may 

31 change gaseous byproduct material and self-luminous compounds into mists, vapors, 

32 respirable dusts, and other physical and chemical forms that have a bearing on potential 

33 doses and their estimation. The extent that byproduct material was released should be 

34 reported, as well as any change to radiation levels if shielding was affected, and any 

35 impacts to other safety features. 

36 (13) The estimated external radiation doses and dose commitments relevant to the 

37 safety criteria in 10 CFR 32.23 and the basis for such estimates. 

38 This is the most critical portion of the application. However, all of the other information 

39 submitted should form the basis of the dose assessments. Additional discussion on 

40 dose assessments is included in Appendix E and an example dose assessment for gun 

41 sights is included in this appendix. 
D–6 

1 (14) A determination that the probabilities with respect to the doses referred to in 

2 10 CFR 32.23(d) meet the criteria of that paragraph. 

3 As indicated in the footnote to 10 CFR 32.23(d), the intent is that as the magnitude of the 

4 potential dose increases, the probability of any individual receiving such a dose must 

5 decrease. The footnote also provides a general guide as to the approximate 

6 probabilities that would be considered low and negligible. Incidents such as accidents, 

7 fires, and misuses should be categorized as low or negligible probability for comparison 

8 with the criteria in 10 CFR 32.24. The probability of occurrence of some potential 

9 incidents will depend on the particular product. Many scenarios would not be highly 

10 dependent on the design of the product. A fire involving the large number of a product 

11 that is likely to be in a warehouse in the distribution chain should be considered a low 

12 probability event. While it is not practical to evaluate all possible scenarios, the dose 

13 assessment should include evaluation of scenarios that are likely to result in the highest 

14 possible dose. Additional information concerning probabilities of occurrence is provided 

15 in Appendix E. 

16 (15) Quality control procedures to be followed in the fabrication of production lots of 

17 the product and the quality control standards the product will be required to meet. 

18 The applicant must also propose methods for demonstrating that the products will be 

19 manufactured in accordance with the approved design on an ongoing basis. Quality 

20 control standards are to be described for the containment, shielding, and any other 

21 safety features. For containment, standards may include material specifications, 

22 specified wall thickness, leakage rates, surface contamination limits, and similar 

23 parameters pertinent to containing the byproduct material. For shielding, standards may 

24 include such parameters as the radiation level at 5 and 25 centimeters from the surface. 

25 Other standards may include maximum quantity of byproduct material in the product and 

26 the acceptable tolerance. Testing procedures for self-luminous products may include 

27 swipe testing as well as brightness, light output, or immersion testing based on the rates 

28 of tritium leakage over a specific time period. 

29 Description of quality control procedures should include any specific sampling, if all 

30 products are not being checked. This would include sampling point and sample size. 

31 Specific inspection methods should be described, such as visual inspection, or other 

32 non-destructive testing. For gaseous tritium light sources, functionality QC may suffice 

33 for verification of containment. Each unit should be checked to ensure that each is 

34 labeled or marked as required. 

35 (16) Any additional information, including experimental studies and tests, required by 

36 the NRC. 

37 This would normally involve additional information provided after the NRC has reviewed 

38 the initial application and determined the need for additional studies or other information. 

39 3.2 Design to Meet Safety Criteria 

40 Each self-luminous product is required to be designed to meet the safety criteria in 

41 10 CFR 32.23 and 32.24: 
D–7 

1 (1) In normal use and disposal of a single product, it is unlikely the external radiation dose in 

2 any one year, or the dose commitment resulting from the intake of radioactive material in 

3 any one year, to a suitable sample of the group of individuals expected to be most highly 

4 exposed to radiation or radioactive material from the product will exceed the dose to the 

5 appropriate organ as specified in Column I of the table in 10 CFR 32.24. 

6 The whole body dose limit in Column I is 1 mrem [10 μSv]. The table also addresses 

7 dose to the head and trunk, active blood-forming organs, gonads, lens of eye, hands and 

8 forearms, feet and ankles, localized areas of skin averaged over areas no larger than 

9 1 square centimeter, and other organs. 

10 (2) In normal handling and storage of the quantities of products likely to accumulate in one 

11 location during marketing, distribution, installation, and servicing of the products, it is 

12 unlikely that the external radiation dose in any one year, or the dose commitment 

13 resulting from the intake of radioactive material in any one year, to a suitable sample of 

14 the group of individuals expected to be most highly exposed to radiation or radioactive 

15 material from the product(s) will exceed the dose to the appropriate organ as specified in 

16 Column II of the table in 10 CFR 32.24. 

17 The whole body dose limit in Column II is 10 mrem [100 μSv]. 

18 (3) It is unlikely that there will be a significant reduction in the effectiveness of the 

19 containment, shielding, or other safety features of the product from wear and abuse 

20 likely to occur in normal handling and use of the product during its useful life. 

21 The prototype tests, along with the information on construction and design, are key in 

22 demonstrating that the product meets this safety criterion. 

23 (4) In use and disposal of a single product, or in handling and storage of the quantities of 

24 product likely to accumulate in one location during marketing, distribution, installation, 

25 and servicing of the product, the probability is low that the containment, shielding, or 

26 other safety features of the product would fail under such circumstances that a person 

27 would receive an external radiation dose or dose commitment in excess of the dose to 

28 the appropriate organ in Column III of the table in 10 CFR 32.24, and the probability is 

29 negligible that a person would receive an external radiation dose or dose commitment in 

30 excess of the dose to the appropriate organ in Column IV of the table. 

31 The whole body dose limit in Column III is 500 mrem [5 mSv] and in Column IV is 15 rem 

32 [150 mSv]. The additional organ limits such as those for lens of eye or skin are more 

33 likely to play a role in these accident criteria. 

34 3.3 Additional Considerations Related to Prototype Testing 

35 3.3.1 General: 

36 The applicant must describe procedures for prototype testing of the product to demonstrate the 

37 effectiveness of the containment, shielding, and other safety features under both normal and 

38 severe conditions of handling, storage, use, and disposal of the product. 

39 Normal use and likely accident conditions include those experienced during installation, use, 

40 handling, maintenance, storage, and transportation (only normal conditions during 
D–8 

1 transportation need to be considered in this context). Applicants should determine an 

2 appropriate method to demonstrate the product’s ability to maintain its integrity when subjected 

3 to conditions of normal use and likely accident conditions. An applicant should describe the 

4 conditions of use for the product and likely accident scenarios. From that description, the 

5 applicant should test the device’s performance in likely accident temperatures, pressures, 

6 impacts, vibrations, and puncture tests. Following each of these tests, the applicant should 

7 evaluate the device for leakage or source dislodging from the source holder, if applicable. 

8 The results of the prototype testing of the product—including any change in the form of the 

9 byproduct material contained in the product, the extent to which the byproduct material may be 

10 released to the environment, any increase in external radiation levels, and any other changes in 

11 safety features—must be provided. 

12 3.3.2 Example of Acceptable Prototype Test for Gun Sights: 

13 At least five gun sights of each model are to be subject to each of the tests described below. 

14 The same gun sight(s) are to be used for each test. Order of the testing is not significant. 

15 Between each test the gun sights are to be visually inspected to ensure there have been no 

16 detrimental effects to the gun sights. The gun sights must not become loosened or detached 

17 from the guns (Tests 3.3.7 & 3.3.8) and the light sources must not become loosened or 

18 detached from the gun sights as a result of any of the tests. Once all tests are completed, the 

19 gun sights are to be subject to the evaluation in Section 3.3.9. 

20 3.3.2.1 Chemical

21 The gun sight is to be immersed for 48 hours at room temperature in each of the following: 

22 • gun oil 

23 • trichloromethane 

24 • cleaning compound according to MIL-C-372B 

25 3.3.2.2 Temperature 

26 High Temperature: The temperature of the gun sight is to be raised from 

27 ambient to 120°C and held at this temperature for 

28 one hour. 

29 Low Temperature: The temperature of the gun sight is to be lowered from ambient to -46°C 

30 and held at this temperature for 48 hours. 

31 Relative Humidity: The gun sight is to be placed in an environment of 100% relative humidity 

32 and a temperature of 42°C and held in this environment for 48 hours. 

33 3.3.2.3 Temperature Shock 

34 The gun sight is to be heated to 80°C and held at this temperature for 15 minutes. The gun 

35 sight is to be transferred, within 15 seconds, to a cold chamber having a temperature of -46°C 

36 and held in this chamber for 15 minutes. If water is used as the cold chamber, it is to be flowing 

37 at a rate of at least 10 times the gun sight volume per minute. If the water is stationary, the 

38 water volume is to be at least 20 times the volume of the gun sight. 
D–9 

1 3.3.2.4 Vibration 

2 The gun sight is to be subject to simple harmonic motion having an amplitude of 0.075 cm. The 

3 vibration cycle is to go from 10 Hz to 50 Hz and back again in approximately 1 minute. This is 

4 to be carried out for 10 cycles. Afterwards, the gun sight is to be subject to 30 minutes of 

5 vibration at resonance frequency. 

6 This test is to be carried out in each of the three principal axes of the gun sight. 

7 3.3.2.5 Pressure 

8 The gun sight is to be placed in a test chamber and exposed to 0.25 and 2.0 bars for 4 periods 

9 of 15 minutes each, the pressure being returned to atmosphere between each period. 

10 3.3.2.6 Penetration 

11 A hammer with a small point and weighing at least 10 g is to be dropped from a height of 

12 1 meter onto the exposed surface of the light source. 

13 3.3.2.7 Mechanical Shock 

14 This test is to be performed with the gun sight attached to the gun that would have the most 

15 detrimental effect on the gun sight. 

16 The gun is to be dropped from 2 meters onto a hard surface (1-inch thick 85 durometer rubber 

17 backed by concrete). The gun is to be dropped 60 times in such a manner that it strikes the 

18 surface ten times in each of the following attitudes: 

19 • Barrel vertical, muzzle down 

20 • Barrel vertical, muzzle up 

21 • Barrel horizontal, bottom up 

22 • Barrel horizontal, bottom down 

23 • Barrel horizontal, left side up 

24 • Barrel horizontal, right side up. 

25 3.3.2.8 Firing 

26 This test is to be performed with the gun sight attached to the gun that would have the most 

27 detrimental effect on the gun sight. The gun is to sequentially fire 5,000 rounds of ammunition 

28 with lapses only sufficient to allow reloading (only one of each model sight needs to be 

29 subjected to the firing test). 

30 3.3.2.9 Evaluation 

31 After each test, the gun sight is to be immersed in water for 24 hours at ambient temperature. 

32 The volume of the water is to be about equal to 10 times that of the volume of the gun sight. 

33 After the gun sight is removed, the activity of the solution is to be measured. The activity of the 

34 solution is to be less than or equal to 1.85 kBq [50 nanocuries]. 
D–10 

1 3.4 Example: Calculating Maximum Doses for Gun Sights Containing 

2 Tritium Gas: 

3 For tritium, the most important modes of exposure are inhalation and absorption through the 

4 skin. Thus, only dose commitments are estimated. 

5 3.4.1 Estimating Radiation Dose Commitments

6 3.4.1.1 Normal Conditions 

7 3.4.1.1.1 Normal Use 

8 The regulation requires that the maximum external radiation levels at 5 and 25 centimeters from 

9 any external surface of the product, averaged over an area not to exceed 10 square 

10 centimeters, and the method of measurement must be specified; however, in the case of tritium, 

11 absent contamination with another radionuclide, such values would be exceedingly low, as the 

12 low energy beta would be absorbed by the glass tube and bremsstrahlung energies would 

13 be low. 

14 The radiation dose commitment that might be anticipated during normal use of the self-luminous 

15 product, in this case a gun sight system, needs to be evaluated. The tritium gas is sealed in 

16 borosilicate glass. While some tritium escapes any enclosure, the amount is very small. No 

17 significant inhalation or ingestion of the tritium is expected in normal use. 

18 3.4.1.1.2 Storage 

19 When large numbers of a product containing tritium are stored, there may be significant 

20 amounts of tritium released. The largest number of an item in one place would normally be in a 

21 warehouse that is the first place stored beyond the control of the distributor licensee. 

22 Distilled water immersion tests on the self-luminous product may be helpful to determine a 

23 tritium leakage rate from the product. 

24 In the following example dose estimate, the leakage rate has been determined to not exceed 

1 × 10-5 25 μCi/source through a water immersion test. Also, it is assumed that 8,000 gun sights 

26 containing three tritium sources each and 2,000 units containing one source each are stored in 

27 a 14 ft × 10 ft room with 10 ft ceilings in a 65,000 sq ft warehouse with an air exchange rate of 

28 1 air change per hour, the calculated equilibrium concentration of tritium is as follows: 

C = I

λV

29 where: 

30 C = equilibrium H-3 gas concentration 

31 I = rate of influx of H-3 gas 

32 λ = air exchange rate 

33 V = volume of the room 

I = 26,000 sources × 1 × 10-5 μCi/source - 24 h = 1.1 × 10-2 34 μCi/h 

V = 1,400 cubic ft × 2.83 × 104

 cc/cubic foot = 3.96 × 107 35 cc 
D–11 

C		= 1.1 ×10-2μCi/h

1 a ch h⁄ ×	ሺ3.96 ×107 ccሻ

= 2.7 ×10-10 μCi/cc 

C = 2.7 × 10-7 1 mCi/cubic meter 

2 For comparison purposes only: The effluent concentration limit set in 10 CFR Part 20, 

Appendix B, Table 2, Column 1 for H-3 in air is 1 × 10-7 μCi/ml (or 1 × 10-7 3 μCi/cc). 

4 The annual dose commitment to a warehouse worker, working in the area for 1 hour/day, 

5 250 days/year, is as follows: 

6 Assume: 

7 • All H-3 gas is converted to tritiated water 

8 • Total rate of absorption of tritiated water into body fluids (mCi/minute) from 

inhalation and skin absorption is 3 × 10-2 9 C where C is the concentration of 

10 tritiated water in air in mCi/cubic meter (ICRP 30) 

• Committed dose equivalent per unit intake of tritiated water is 1.7 × 10-11 11 Sv/Bq 

[6.3 × 10-2 12 rem/mCi]

13 • Annual committed dose: 

H = 2.7 × 10-7 mCi/cubic meter × 3 × 10-2 14 mCi-cubic meter/mCi-minute × 

60 minute/hour × 250 h/yr × 6.3 × 10-2 rem/mCi = 7.7 × 10-6 15 rem/year 

16 H = 0.008 mrem/year 

17 A similar type calculation in NUREG/CR-0215, “Estimates of Potential Radiation Doses from 

18 Wristwatches Containing Tritium Gas” yields a committed dose of 50 mrem from exposure to 

2.5 × 10-5 μCi/cc for 24 hours or 8.3 × 104 19 mrem-cc/μCi-h. Using that factor, the annual 

20 committed dose to a warehouse worker would be: 

8.3 × 104

 mrem-cc/μCi-h × 250 h/yr × 2.7 × 10-10 21 μCi/cc = 0.006 mrem 

22 3.4.1.1.3 Transportation 

23 Assume a truck driver transports all sights to be stored in the warehouse in a single truckload 

24 and spends a total of 2 hours in the trailer loading and unloading. 

 V = 2.9 × 107 25 cc (NUREG/CR-0215) 

 I = 1.1 × 10-2 26 μCi/h 

27 λ = 1 a ch/h

C	ൌ

1.1 × 10-2 μCi/h

1 a ch h⁄ ×	ሺ2.9 × 107 ccሻ

= 3.8 ×10-10 μ Ci cc ⁄
D–12 

1 Dose commitment: 

H = 3.8 × 10-7 mCi/cubic meter × 3 × 10-2 2 mCi-cubic meters/mCi-minute × 2 hours × 

60 minutes/hour × 6.3 × 10-2 3 rem/mCi 

H = 8.6 × 10-8 rem = 8.6 × 10-5 4 mrem 

5 3.4.1.1.4 All Other Situations During Normal Use, Storage, and Transportation 

6 All other situations during normal use, storage, and transportation involve smaller quantities of 

7 H-3 and/or shorter exposure times thus would result in lower dose commitments. 

8 3.4.1.1.5 Disposal 

9 NUREG/CR-0215 provides disposal dose commitment estimates for burial of tritium lighted 

10 wristwatches in landfills and by incineration. However, these are highly conservative and 

11 assume large numbers disposed. The highest calculated dose is from assumed ground level 

12 burning resulting in up to 17 mrem/yr to the maximally exposed person. If a more reasonable 

13 number of gun sights are burned and one accounts for the smaller amount of material in each 

14 as compared to the watches, the maximum dose would be approximately 0.03 mrem/yr. 

15 3.4.1.2 Accident Conditions 

16 3.4.1.2.1 Use 

17 The maximum credible accident involving the use of the gun sight system is rupture of the 

18 source and instantaneous release of the gas during firing. Only the rear sight is of consequence 

19 since it is much closer to the breathing zone of the user than the front sight. 

20 Assume: 

21 • Rear sight contains a total of 12 mCi of H-3 gas 

22 • Rear sight is 15 cm from the user’s face 

23 • Breathing zone can be represented by a cone with apex at the source and base, a 

24 10 cm diameter circle at the user’s face 

25 • All H-3 is converted to tritiated water instantly 

26 • Effective half-life for tritiated water = 10 days 

27 • Total absorption of inhaled tritium in body fluids 

28 • Mass of soft tissue = 63,000 g (ICRP 30) 

29 Fraction of gas released in the direction of the breathing zone: 

F =

π r 2

4 π R2

 
D–13 

1 where: 

2 r = radius of the base of the cone 

3 R = distance from source to nose 

F = 3.14 × 5 ×	ሺ5 sq cmሻ

4 × 3.14 × 15 ×	ሺ15 sq cmሻ = 0.03 

4 Maximum estimated dose commitment to user assuming all H-3 gas is converted to 

5 tritiated water 

H = 12 mCi × 0.03 × 6.3 × 10-2 6 rem/mCi = 23 mrem 

7 For such an accidental instantaneous release, most of the gas would remain as elemental H-3. 

8 The dose commitment from H-3 gas would be approximately 1,000 times less than for tritiated 

9 water, based on the dose conversion factors for inhalation and skin absorption. The total 

10 estimated dose commitment would be 2 percent of the calculated value since up to 2 percent of 

11 the gas originally in the glass capsule could be in the form of tritiated water. 

12 3.4.1.2.2. Storage 

13 The maximum credible accident involving storage of the gun sights would involve a fire in the 

14 storage area which ruptures some of the borosilicate glass capsules. Assume: 

15 • 50 percent of the sources ruptured 

16 • Immediate dispersion of the gas within the storage area 

17 • Conversion of all H-3 gas to tritiated water (oxidation is rapid under 

18 fire conditions) 

19 Total rate of absorption of tritiated water into body fluids (mCi/minute) from inhalation and skin 

absorption is 3 × 10-2 20 C where C is the concentration of tritiated water in air in mCi/cubic meter 

21 (ICRP 30). 

C =

266 Ci × 0.50

3.96 ×107

 cc = 3.3 × 10-6Ci/cc	ൌ	

= 3.3 × 103 22 mCi/cubic meter 

23 Dose commitment: 

H = 3.3 × 103

 mCi/cubic meter × 3 × 10-2 mCi - cubic meter/mCi-min × 6.3 × 10-2 24 

25 rem/mCi 

26 H = 6.2 rem/minute 

27 Dose commitment to the firefighter remaining in enclosed area without respiratory protection for 

28 2 minutes for purpose of rescue = 12 rem 

29 This calculation greatly overestimates the true dose commitments in this situation. Air currents 

30 would disperse the gas very rapidly in the case of a fire, particularly one of such severity as to 

31 rupture 50 percent of the sources instantaneously. Conditions in such a fire would limit the time 

32 a person could be present without respiratory protection without being fatally exposed to other 

33 toxins. Normally a fireman would wear respiratory protection, which would reduce intakes by a 
D–14 

1 factor of 1,000; however, the length of time of exposure while wearing respiratory protection 

2 could be higher. 

3 3.4.1.2.3 Ingestion of Content 

4 Ingestion of the entire H-3 content of the front gun sight (17 mCi). 

H = 17 mCi × 6.3 × 10-2 5 rem/mCi = 1.1 rem 

6 This calculation assumes the entire 17 mCi H-3 gas is converted to tritiated water. 

7 3.4.2 Example Continued: Compliance With 10 CFR 32.23 and 32.24 

8 The following provides information concerning how to use the example dose calculations above 

9 to demonstrate compliance with 10 CFR 32.23 and 10 CFR 32.24. 

10 3.4.2.1 Normal Use, Storage, and Transportation 

11 1. No significant external dose or dose commitment is expected in normal use of the gun 

12 sight system; so clearly less than the values in Column I of the table in 10 CFR 32.24. 

13 2. The maximum expected dose commitment to workers in the storage area is less than 

14 1 mrem/year. The maximum credible dose commitment during transportation is lower. 

15 These values are within the limits set in Column II of the table in 10 CFR 32.24. 

16 3.4.2.2 Accidental Release of the Tritium Gas 

17 1. Under maximum credible conditions of use of the equipment, the dose commitment to an 

18 individual would not exceed 23 mrem, within the limits set in Column III of the table in 

19 10 CFR 32.24. In the highly improbable case where an individual ingested the contents 

20 of an entire source, the estimated dose commitment is 1 rem. This is within the limits set 

21 in Column IV of the table in 10 CFR 32.24. 

22 2. Under extreme fire conditions in the storage area, the estimated maximum dose 

23 commitment to an occupant of the area is 6 rem; to a fireman in the process of rescue, 

24 12 rem. More reasonable values based on 2 percent of the H-3 gas remaining in the 

25 storage room are 12 mrem and 24 mrem respectively. Thus, even under extreme 

26 conditions, the dose commitments would be within the values in the table in 

27 10 CFR 32.24. The occurrence of a fire in a warehouse is not a negligible probability 

28 event. However, a person being exposed under the worst possible conditions has a 

29 lower probability. It is appropriate to compare the maximum possible dose calculated to 

30 Column IV values, and any more realistic estimates for the maximum dose from a fire to 

31 Column III values. 

32 3.4.2.3 Disposal 

33 The criteria apply only to the disposal of 1 unit. The potential doses from the disposal of a 

34 single product are orders of magnitude less than the criteria in Column I of the table in 

35 10 CFR 32.24. Nonetheless, the NRC intends that a quantitative estimate of the potential dose 

36 be made, either for a single item, as required by the regulations, or from the number likely to be 

37 disposed at one site as is done in NUREG/CR-0215 and NUREG-1717, “Systematic 
D–15 

1 Radiological Assessment of Exemptions for Source and Byproduct Materials.” This is because 

2 the NRC must be able to consider the combined impact from all products disposed in a landfill 

3 or a municipal incinerator. 

4 Bibliography 

5 1. American National Standards Institute, Inc., ANSI/SAAMI Z299.5-1996 American National 

6 Standard Voluntary Industry Performance Standards Criteria of New Firearms Designs 

7 Under Conditions of Abusive Mishandling for the Use of Commercial Manufacturers 

8 (Connecticut: Sporting Arms and Ammunition Manufacturers’ Institute, Inc., originally 

9 approved 1985). 

10 2. American National Standards Institute, American National Standard N43.4 - 2005; 

11 Classification of Radioactive Self-Luminous Light Sources (Health Physics Society, 

12 McLean VA, 2005). 

13 3. Department of the Army, US Army Weapons Command, Supplementary Quality 

14 Assurance Provisions No. 12002965 Low Light Level Sight Kit; M16/M16A1 Rifle. 

15 4. International Atomic Energy Agency, Safety Series No. 23 Radiation Protection Standards 

16 for Radioluminous Timepieces (Vienna: International Atomic Energy Agency, 1967). 

17 5. U.S. Nuclear Regulatory Commission, Consumer Product Policy Statement, 

18 January 16, 2014, 79 FR 2907. 

1 APPENDIX E 

2 PRODUCTS COVERED UNDER CLASS EXEMPTIONS: 

3 SAFETY CRITERIA AND DOSE ASSESSMENTS 

E–1 

1 Products Covered Under Class Exemptions: Safety Criteria and Dose 

2 Assessments 

3 The regulations in Title 10 of the Code of Federal Regulations (10 CFR) 10 CFR Part 30, 

4 Sections 30.14 through 30.22, provide exemptions to persons from the requirements for a 

5 license set forth in Section 81 of the Act and from the regulations in 10 CFR Parts 30 through 36 

6 and 39 to the extent that such person receives, possesses, uses, transfers, owns or acquires 

7 products described in the aforementioned sections. The types of exemptions described in 

8 Sections 30.14 through 30.18 are known as “product-specific” exemptions, while those 

9 described in in Sections 30.19 through 30.22 are referred to as “class exemptions.” 

10 Class exemptions cover a broad class of products with similar characteristics and purposes. 

11 They are not limited to certain quantities of certain radionuclides as is typical for product-specific 

12 exemptions. In the case of class exemptions, many products can be approved for use through 

13 the licensing process if the applicant for a distribution license demonstrates that the specific 

14 product is within the class and meets certain safety criteria. The U.S. Nuclear Regulatory 

15 Commission’s (NRC’s) regulations currently include three “class exemptions”: (1) self-luminous 

16 products (10 CFR 30.19), (2) gas and aerosol detectors (10 CFR 30.20), and (3) industrial 

17 devices (10 CFR 30.22). 

18 Safety Criteria 

19 The safety criteria [in 10 CFR 32.23 and 10 CFR 32.24, or 10 CFR 32.27 and 10 CFR 32.28, or 

20 10 CFR 32.31] are primarily radiation dose criteria. The requirements [in 10 CFR 32.22, 

21 10 CFR 32.26, and 32.30] for information to be submitted in an application to distribute products 

22 under any of these class exemptions include a lot of specific information about the proposed 

23 product and a dose assessment relevant to the safety criteria and the basis for the dose 

24 estimates [10 CFR 32.22(a)(2)(xiii), 10 CFR 32.26(b)(13), and 10 CFR 32.30(b)(13)]. The 

25 application must also include a determination that the probabilities of the accident scenarios 

26 with respect to the accident dose criteria meet those criteria [10 CFR 32.22(a)(2)(xiv), 

27 10 CFR 32.26(b)(14), and 10 CFR 32.30(b)(14)]. 

28 A dose assessment to demonstrate that the product meets the safety criteria must be consistent 

29 with all of the information submitted about the product, its projected life, and projected extent of 

30 distribution [under 10 CFR 32.22(a)(2), 10 CFR 32.26(b), or 10 CFR 32.30(b)]. 

31 Dose Assessment 

32 To demonstrate that a product meets the applicable safety criteria, a dose assessment must be 

33 developed that essentially accounts for the product throughout its entire life cycle after being 

34 transferred from the specifically licensed manufacturer and/or distributor including its ultimate 

35 disposal. This includes all distribution stages after the product leaves the initial distributor. In 

36 order to be able to adequately assess the potential doses that could result from transferring a 

37 product for use under a class exemption, it must be possible to anticipate how the product will 

38 ultimately be used and the likely conditions of use. This must include routine conditions, as well 

39 as likely and unlikely accident and misuse scenarios. 
E–2 

1 Note: even if some users might hire someone else to service a device, there are no controls on 

2 servicing of an exempt product, so doses that may occur as a result of servicing must also be 

3 estimated with respect to the safety criteria for normal handling. Servicing covered by the 

4 exemption, however, does not include refurbishment or source replacement, and redistribution; 

5 these activities must take place under an applicable distribution license. 

6 A distributor should be able to make reasonable assumptions about how the product/device will 

7 be used, how people are likely to be exposed to the radioactive material within or to the 

8 radiation produced, as well as the conditions under which their product/device would be used. 

9 The reviewer needs to determine if the assumptions presented are indeed reasonable and 

10 should consider whether there are other likely uses than the intended uses stated and evaluated 

11 by the applicant. This becomes particularly important if the projected doses are approaching an 

12 applicable limit. 

13 Because of the nature of self-luminous products (i.e., that they have a wide range of potential 

14 applications, and might easily be widely used for purposes other than those originally intended), 

15 the regulations not only exclude products primarily for frivolous purposes and toys or 

16 adornments [10 CFR 30.19(c)], but also specifically indicate that the NRC may deny an 

17 application for a distribution license if the end uses of the product cannot be reasonably 

18 foreseen [10 CFR 32.22(b)]. 

19 The NRC has approved the distribution for use under 10 CFR 30.19 of gun sights not already 

20 installed on a gun; however, in such a case, it should be clear that the product is designed for 

21 attachment to a gun and that the scenarios of use can be adequately anticipated in order to 

22 develop a sound dose assessment. It is also important in this situation that the required label 

23 be visible even after the sight is installed on a gun. In addition, appropriate prototype tests also 

24 include testing with the sights attached to the gun. 

25 Most of the exemptions cover finished products. In order for a product to be approved for use 

26 under one of the class exemptions, the product must fit the class of products as described in the 

27 exemption. For example, the class “self-luminous products” encompasses gun sights, while an 

28 ion chamber itself is not considered a “gas and aerosol detector.” In any case, it is important to 

29 be able to make reasonable assumptions about the factors that affect the likely and possible 

30 doses resulting throughout the lifecycle of the product. 

31 If a previously licensed device is to be used within another device (such as an electron capture 

32 detector (ECD) used in a gas chromatograph), it should not be assumed that it will be 

33 acceptable to approve anything but the complete device (in this case, a gas chromatograph) as 

34 an exempt industrial device. When a product is to be used under an exemption from licensing, 

35 it is particularly important to evaluate the safety implications of the conditions of use. The NRC 

36 will not approve the partial device for use under a class exemption, as it does not itself fit the 

37 class (i.e., the product exempted must perform the function described in the exemption). The 

38 NRC may consider approving a device, where a portion is separable by the user, but only if 

39 there is a justification based on a practical issue, such as a source needing to be replaced 

40 periodically and only if the safety implications are adequately evaluated and found to be 

41 acceptable given the safety criteria for the product. If it is proposed to seek approval of a device 

42 where a portion of the device may be separated in order to allow, for example, a needed change 

43 out, the dose assessment must adequately consider the variation in conditions under which 

44 individuals will potentially be exposed. It is necessary to evaluate the various scenarios of use 

45 when handling a portion of a device, where the remainder of the device is not fully evaluated 

46 and approved by the NRC as it does not contain radioactive material. 
E–3 

1 In such a situation, the NRC will also be concerned with the methods of marketing and labeling 

2 such that it will be clear that, for example, the ECD is manufactured specifically for use in 

3 particular gas chromatographs (the use of which has been evaluated by the NRC), information 

4 on the radionuclide and activity and instructions for proper use are made available, and the 

5 source or other separable portion is unlikely to be used in other applications not evaluated and 

6 approved by the NRC. 

7 For each of the class exemptions, one of the safety criteria is that it is unlikely that there will be 

8 a significant reduction in the effectiveness of the containment, shielding, or other safety features 

9 of the product/device from wear and abuse likely to occur in normal handling and use of the 

10 product or device during its useful life [10 CFR 32.23(c), 10 CFR 32.27(b), and 

11 10 CFR 32.31(a)(3)]. The prototype tests are important in demonstrating that the product will 

12 meet this criterion, and need to represent the conditions that the product will likely encounter 

13 during its life. These products are not expected to maintain integrity under severe accident 

14 conditions, but any adverse environmental conditions a product might be exposed to in use 

15 need to be considered. Even if products are shown to have a low probability of releasing 

16 material under severe accident conditions, the dose assessment for severe accidents, such as 

17 fire and explosion, should assume that the material is not contained. 

18 For products to be distributed for use under 10 CFR 30.19 or 10 CFR 30.20, the safety criteria 

19 for normal use and disposal scenarios only require the assessments to consider one item. For 

20 all of the other scenarios; i.e., normal handling and storage, as well as potential accidents, 

21 during marketing, distribution, installation, and servicing of the product, the safety criteria 

22 require estimating the maximum number of the product likely to be in one place in each of 

23 these scenarios. 

24 For products to be distributed for use under 10 CFR 30.22, the safety criteria for all scenarios 

25 require considering the number of the product likely to accumulate in one location for each 

26 scenario. Thus, the applicant needs to address how many of a device might reasonably be 

27 used in the same proximity such that the same worker would be exposed under normal 

28 conditions. Also, the criterion for disposal in 10 CFR 32.31(a)(2) is 10 μSv [1 mrem]/year. This 

29 involves estimating the number of a devices likely to be disposed of in the same disposal site, 

30 landfill, municipal incinerator, or, if applicable, scrap metal recycling facility (i.e., if significant 

31 metal content). For each category of disposal, there are a number of potentially exposed 

32 groups. The critical group needs to be identified, or estimates of doses made for members of 

33 all groups. 

34 The exemption becomes applicable at the first step in the distribution process once it leaves the 

35 manufacturer and/or initial distributor; this is usually where the largest quantity of a product 

36 would be together outside of the specifically licensed manufacturing facility. The number 

37 assumed would depend on the overall market projection (e.g., on the order of 10 million smoke 

38 detectors are distributed in a year). Thus 10,000 may easily be in one shipment and even more 

39 may be stored in a first line warehouse. For products projected to be distributed in much 

40 smaller numbers, it may be reasonable to assume a significantly smaller number, such as a few 

41 hundred, are ever in one place in the distribution chain. This estimate is often most relevant to 

42 the risk presented by a fire or explosion. 

43 For each of the safety criteria relating to accident and misuse scenarios for each of the three 

44 class exemptions [10 CFR 32.23(d), 10 CFR 32.27(c), and 10 CFR 32.31(a)(4)], there is a 

45 footnote that provides a general guide that a “low probability event” is a failure that occurs no 

46 more than once per year for 10,000 exempt units distributed and a “negligible probability event” 
E–4 

1 is one that would occur no more than once per year per 1 million exempt units distributed. As a 

2 warehouse fire or major truck accident involving fire or explosion are fairly common 

3 occurrences, the estimated potential doses from these scenarios should be compared to the low 

4 probability event criterion, i.e., 5 mSv [500 mrem]. 

5 The use of previously developed assessments such as NUREG-1717 

6 The analyses presented in NUREG-1717 may be of great assistance in developing a dose 

7 assessment for a product proposed for distribution under a class exemption, particularly if the 

8 applicant is proposing to distribute a product essentially the same as one specifically analyzed. 

9 However, this document must be used very carefully with any differences in the product, its 

10 projected conditions of use, or other aspects of its expected lifecycle, identified and analyzed. 

11 Also, factors assumed in that analysis may change over time and such changes need to be 

12 considered. For example, the generic disposal analysis assumes that the numbers of products 

13 being disposed in landfills are disposed in equal fractions to each landfill in the country with the 

14 number of landfills nationally being about 3,500 at the time. This number has declined 

significantly, being less than half this number in 2005,1

 and 1,908 in 2009,2 15 which would cause 

16 larger numbers to go to each landfill. This would increase the estimated doses from landfill 

17 disposal for most of the exposed groups. Likewise, the number of municipal incinerators 

18 declined from the 150 assumed in NUREG-1717 to 98 in 2005. The U.S. Environmental 

19 Protection Agency’s (EPA’s) report on municipal solid waste for 2009, instead of identifying the 

20 number of municipal incinerators, reports 87 waste-to-energy facilities in 2009, and indicates 

21 that almost all combustion of waste involves energy recovery. Again, with fewer such facilities, 

22 more of a product will be disposed in each, raising the potential doses for some pathways or 

23 exposed groups. 

24 The class of the industrial product exemption is quite broad and only certain typical products 

25 that have been generally licensed in the past and that were believed to possibly be candidates 

26 for exemption were analyzed (in Section 4 of NUREG-1717). Calibration and reference sources 

27 were also analyzed, but these are not covered by the exemption for certain industrial devices. 

28 The appendices of NUREG-1717 cover generic assessment of accidents, distribution, and 

29 disposal, which may be adapted for a product not specifically covered in the earlier parts of the 

30 document. 

31 Checklist for Specific Scenarios Analyzed in Dose Assessment for Applications under 10 

32 CFR 32.22 and 32.26 

33 A checkmark in each box in the table below indicates that the appropriate assessments are 

34 included in your application package for each of the scenarios described in 10 CFR 32.23(a)-(d) 

35 and 32.27(a)-(c) 

 

1

U. S. Environmental Protection Agency (EPA). 2006. Municipal Solid Waste in the United States: 2005 Facts and 

Figures. EPA530-R-06-011. Municipal and Solid Waste Division, Office of Solid Waste, EPA: Washington, DC. 

2

U. S. Environmental Protection Agency (EPA). 2009. Municipal Solid Waste in the United States: 2009 Facts and 

Figures. EPA530-R-10-012. Office of Solid Waste, EPA: Washington, DC. December 2010.
E–5 

Normal Conditions External Dose Internal Dose 

Marketing, distribution, 

and transport [ ] [ ] 

Handling, use, and 

storage [ ] [ ] 

Disposal [ ] [ ] 

Landfills [ ] [ ] 

Incinerators [ ] [ ] 

Recycle [ ] [ ] 

Accidents and Misuse Low 

Probability 

Negligible 

Probability 

Low 

Probability 

Negligible 

Probability 

During distribution and 

transport [ ] [ ] [ ] [ ] 

During use [ ] [ ] [ ] [ ] 

During installation and 

servicing [ ] [ ] [ ] [ ] 

1 Note: 10 CFR 32.23 stated it is the intent of this paragraph that as the magnitude of the 

2 potential dose increases above that permitted under normal conditions, the probability that any 

3 individual will receive such a dose must decrease. The probabilities have been expressed in 

4 general terms to emphasize the approximate nature of the estimates which are to be made. 

5 The following values may be used as guides in estimating compliance with the criteria: 

6 Low—not more than one such failure per year for each 10,000 exempt units distributed. 

7 Negligible—not more than one such failure per year for each 1 million exempt units distributed. 

8 Checklist for Specific Scenarios Analyzed in Dose Assessment for Applications Under 

9 10 CFR 32.30

10 A checkmark in each box in the table below indicates that the appropriate assessments are 

11 included in the application package for each of the scenarios described in 10 CFR 32.31(a)-(b) 

Normal Conditions External Dose Internal Dose

Marketing, distribution, and 

transport [ ] [ ] 

Handling, use, and storage [ ] [ ] 

Disposal [ ] [ ] 

Landfills [ ] [ ] 

Incinerators [ ] [ ] 

Recycle [ ] [ ] 

Specified misuse 
E–6 

Normal Conditions External Dose Internal Dose

Unshielded source 

1,000 hours at 1 meter [ ] [ ] 

Intake of 10-4 of BPM in 

device (or 10% of tritium) [ ] [ ] 

Skin dose from source in 

pocket for 80 hours 

(if possible) 

[ ] [ ] 

Accidents and Misuse Low 

probability 

Negligible 

probability 

Low 

probability 

Negligible 

probability 

During distribution and 

transport [ ] [ ] [ ] [ ] 

During use [ ] [ ] [ ] [ ] 

During installation and 

servicing [ ] [ ] [ ] [ ] 

1 Note: 10 CFR 32.31 stated it is the intent of this paragraph that as the magnitude of the 

2 potential dose increases above that permitted under normal conditions, the probability that any 

3 individual will receive such a dose must decrease. The probabilities have been expressed in 

4 general terms to emphasize the approximate nature of the estimates that are to be made. The 

5 following values may be used as guides in estimating compliance with the criteria: 

6 Low—not more than one such failure/incident per year for each 10,000 exempt units distributed. 

7 Negligible—not more than one such failure/incident per year for each one million exempt units 

8 distributed. 
1 APPENDIX F 

2 QUESTIONS AND ANSWERS ABOUT SOURCE MATERIAL REGULATIONS 

F–1 

1 Questions and Answers About Source Material Regulations 

2 In 2013, the NRC amended its regulations in 10 CFR Part 40 to require that the initial 

3 distribution of source material to exempt persons or to general licensees be explicitly authorized 

4 by a specific license, which includes new reporting requirements. The rule is intended to 

5 provide the NRC with timely information on the types and quantities of source material 

6 distributed for use either under exemption or by general licensees. In addition, the rule modifies 

7 the existing possession and use requirements of the general license for small quantities of 

8 source material to better align the requirements with current health and safety standards. 

9 Finally, the rule revises, clarifies, or deletes certain source material exemptions from licensing to 

10 make the exemptions more risk informed. This rule affects manufacturers and distributors of 

11 certain products and materials containing source material and certain persons using source 

12 material under general license and under exemptions from licensing. 

13 The “Question and Answer” format of this appendix is intended to provide a simplified means for 

14 applicants to understand the requirements of this recent addition to the NRC regulations.

15 Q1. Are there any restrictions placed on a person exempt from licensing?

16 A1. Most product exemptions do not have conditions for the possession, use, and disposal 

17 of the product. The primary exceptions are for uranium counterweights exempt under 

18 Title 10 of the Code of Federal Regulations (10 CFR) 40.13(c)(5) (which are exempt only 

19 when they are installed in aircraft, rockets, projectiles, and missiles or stored or handled 

20 in connection with installation or removal of such counterweights—see RIS-05-003, 

21 “NRC Regulatory Issue Summary 2005-03: 10 CFR Part 40 Exemptions for Uranium 

22 Contained in Aircraft Counterweights—Storage and Repair,” issued February 2005, for 

23 more details) and for lenses exempt under 10 CFR 40.13(c)(7) (which cannot be used as 

24 eyepieces, spectacles, or contact lenses). In addition, certain exemptions prohibit 

25 modification of the exempt product. 

26 Q2. Do I need to obtain a license under 10 CFR 40.52 if I only distribute source 

27 material that is under 0.05 percent by weight [10 CFR 40.13(a)] or is in the form of 

28 unrefined and unprocessed ore [10 CFR 40.13(b)]? 

29 A2. Unless your material is described in 10 CFR 40.13(c), you are not required to obtain a 

30 license for initial distribution of the material. 

31 Q3. May I initially transfer or distribute source material to persons exempt under 

32 10 CFR 40.13(c)?

33 A3. You may not initially transfer for sale or distribute a product containing source material to 

34 a person exempt from the regulations under 10 CFR 40.13(c) unless it is authorized by a 

35 specific license under 10 CFR 40.52 [see 10 CFR 40.13(c)(10)]. 

36 Q4. Do I require a license for source material if I import the source material and am 

37 eligible to receive, possess, use, or transfer it under an exemption? 

38 A4. To the extent that such importation is authorized under the provisions of 10 CFR 

39 Part 110, you may import source material, for your own possession and use under the 

40 exemptions provided in 10 CFR 40.13. 
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1 If you import source material that is exempt under 10 CFR 40.13(c) for the purpose of 

2 sale or distribution within the United States, you are required to obtain a specific 

3 license from the U.S. Nuclear Regulatory Commission (NRC) in accordance with 

4 10 CFR 40.13(c)(10) and 10 CFR 40.52 before such distribution unless the person who 

5 provides it to you did so under the provisions of a specific license issued under 

6 10 CFR 40.52. 

7 Q5. May I export source material that is eligible for possession or use under an 

8 exemption that I have for sale?

9 A5. To the extent such exportation is authorized under the provisions of 10 CFR Part 110, 

10 you may export source material. A specific license issued under 10 CFR 40.52 is not 

11 required for distributions that are directly exported. 

12 Q6. If I meet the requirements for an exemption, are there any NRC requirements for 

13 disposing of or transferring my exempted source material?

14 A6. Generally, no. However, the restrictions in 10 CFR 40.13(c)(4) and (c)(5) may impact 

15 the disposal or transfer options for finished products and parts fabricated of, or 

16 containing tungsten or magnesium-thorium alloys and aircraft counterweights. Disposal 

17 options for counterweights are discussed in RIS-01-013, “10 CFR Part 40 Exemptions 

18 for Uranium Contained in Aircraft Counterweights.” 

19 Q7. I bought a piece of glazed ceramic tableware that contains source material. Do I 

20 or the seller need to determine if it meets the constraints of the exemption or 

21 confirm the manufacture date? 

22 A7. No. Neither you nor a seller is required to determine if the product falls within the 

23 constraints of the exemption. In all likelihood, the seller of such products today would in 

24 fact be a reseller (e.g., a dealer in antiques) and not a manufacturer, because the 

25 manufacture of such products is believed to have ended long ago. A reseller would 

26 have obtained the tableware under the exemption and would be unlikely to be able to, 

27 and is not required, to verify the manufacture date or uranium content of the tableware. 

28 In addition, in accordance with 10 CFR 40.13(c)(2)(i), glazed ceramic tableware is no 

29 longer allowed to be manufactured for use under the exemption or imported if 

30 manufactured after August 27, 2013. 

31 Q8. Does a seller or purchaser of glassware containing source material or finished 

32 optical lenses or mirrors need to determine if it meets the percent by weight limits 

33 of the exemption or to confirm the manufacture date? 

34 A8. No. Neither the purchaser nor the seller, unless the seller is the initial distributor (the 

35 manufacturer or an importer) of the product, is required to determine if the product falls 

36 within those constraints of the exemption. If you have glassware containing source 

37 material or finished optical lenses with thorium, it is assumed to meet the applicable 

38 limits at the time of manufacture for use under 10 CFR 40.13(c)(2)(iii) or (c)(7). It is the 

39 burden of the initial distributor of these products to ensure that the products are 

40 manufactured in accordance with the exemption. 
F–3 

1 Q9. Does the exemption provided by 10 CFR 40.13(c)(2)(iii) extend to ceramics used in 

2 industries other than residential or commercial building construction, given the 

3 exclusion of ceramic in construction and the fact that other exemptions cover 

4 certain ceramics? 

5 A9. No. The fact that there are other exemptions that cover other specific types of ceramics 

6 is evidence that the exemption in 10 CFR 40.13(c)(2)(iii) is not meant to cover all 

7 ceramics (other than building construction). The phrasing is used because some 

8 ceramics may include a glazing that could be considered to be glass and thus are not 

9 appropriate for residential or other building construction uses. 

10 Q10. How can I determine if an optical instrument is coated with or contains 

11 source material? 

12 A10. Packaging or labeling of the optical instrument may identify whether source material was 

13 used in the product. Otherwise, there is no easy way for a consumer to determine if an 

14 optical instrument’s eyepiece is coated with source material other than contacting the 

15 manufacturer of the gun scope or optical instrument. 

16 Q11. Are there any restrictions on how optical lenses with thorium or uranium in or on 

17 them might be used in my products that I plan to distribute?

18 A11. The lenses may not be used in eyepieces (i.e., lenses in close proximity to the eye when 

19 in use), in binoculars, or in other optical instruments. Also, uranium and thorium may not 

20 be used or contained in spectacles or contact lenses. As long as you did not 

21 manufacture the lenses themselves and do not modify the lenses that contain source 

22 material, you would have no additional requirements from the NRC related to the lenses 

23 or the product containing the lenses. If you do alter (e.g., shape, grind, or polish) the 

24 lenses containing source material or initially apply a coating of source material to the 

25 lenses prior to or during installation in a final product, you need a license to do so. In 

26 addition, if you plan to subsequently transfer or distribute those modified products to 

27 another person for possession and use under the exemption in 10 CFR 40.13(c)(7), you 

28 need a specific license authorizing initial distribution of the product under 10 CFR 40.52 

29 [see 10 CFR 40.13(c)(10)], because this is considered to be initial distribution of a new 

30 product. 

31 Q12. Are windows coated with or containing uranium or thorium exempt from licensing 

32 under 10 CFR 40.13(c)(7)? 

33 A12. As published and referenced in the Federal Register notice for the final rule “Distribution 

34 of Source Material To Exempt Persons and General Licensees and Revision of General 

35 License and Exemptions” (78 FR 32309), the NRC defines a lens as “a piece of 

36 transparent material (as glass) that has two opposite regular surfaces either both curved 

37 or one curved and the other plane and that is used either singly or combined in an 

38 optical instrument for forming an image by focusing rays or light.” If the purpose of a 

39 window is to only transmit light (not reflect or focus it), the NRC does not consider the 

40 window to be a lens or mirror falling under the exemption. In no circumstances does the 

41 exemption allow the lens to be used as an eyepiece or a viewing port where the eye 

42 could come in close contact with the coated “window.” 
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1 Q13. If a lens or mirror contains less than 0.05 percent by weight of uranium or thorium, 

2 may I distribute the lens or mirror under the exemption in 10 CFR 40.13(a) in order 

3 to avoid having to obtain a specific license issued under 10 CFR 40.52 for 

4 distributing products for use under exemption? 

5 A13. When determining the applicable exemption, it would be inappropriate to use the 

6 exemption in 10 CFR 40.13(a) for a product in which the source material is intentionally 

7 applied or included, because there is a specific exemption that is more applicable to the 

8 product. As a result, in order to distribute such products, you are required to obtain a 

9 specific license authorizing distribution under 10 CFR 40.52. 

10 Q14. I own a small mineral collection that contains several pieces of uranium ore. Do I 

11 need a license to sell my collection? 

12 A14. No. Unprocessed ore is exempt from any licensing requirements under 

13 10 CFR 40.13(b). There are no requirements associated with the distribution of 

14 unprocessed ore. Note that if you plan to take any actions to process the ore samples, 

15 you will need a license before doing the processing. 

16 Q15. My antique store has some glazed ceramic Fiesta tableware that may contain 

17 source material. Do I need to obtain an NRC license? 

18 A15. No. Although the brand Fiestaware tableware is still being manufactured, all tableware 

19 that had uranium glazes added were manufactured and initially transferred long ago. 

20 The seller of such products today would in fact be a reseller (e.g., a dealer in antiques) 

21 and not a manufacturer or initial distributor. Therefore you would not need a license for 

22 possession or initial distribution. 

23 Q16. As part of my application for a specific license for initial distribution, if I am 

24 importing a finished optical system, should I provide the individual different lens 

25 weights or the weight of the finished optical product in response to the 

26 requirement in 10 CFR 40.52(b)(1)? 

27 A16. To the extent practicable, you should provide the quantity (weight) of source material 

28 contained on or in each individual lens. You should also provide the weight of each lens 

29 in order to demonstrate compliance with 10 CFR 40.52(c), that the concentration (weight 

30 percent) does not exceed the applicable limit. 

31 Q17. I plan to manufacture depleted uranium as shielding in shipping containers. My 

32 products are frequently custom-made, and the amount of depleted uranium used 

33 can vary greatly depending on the customer’s need. What information will the 

34 NRC require me to include in my license application?

35 A17. If there is significant variation in the products, you should provide some general 

36 information on the ranges of sizes and weights, and/or lists of models with more specific 

37 information to the extent practical. The most important information for this product would 

38 be about the labeling and encasement, to show that they will meet the constraints in the 

39 exemption [10 CFR 40.13(c)(6)]. 
F–5 

1 Q18. I sell uranium glass marbles [exempt under 10 CFR 40.13(c)(2)(iii)]. Is a single 

2 marble considered to be a unit for the purposes of labeling?

3 A18. Although a single marble could be considered a unit, the labeling of individual marbles is 

4 not required. Instead, labeling a bag or other container of marbles that the end-user is 

5 expected to see would be acceptable. 

6 Q19. If I sell bulk quantities of coated lenses, do I need to propose labeling or marking 

7 for each item or would it be acceptable to just propose a single marking on a 

8 package contains multiple lenses? 

9 A19. Labels on packaging of multiple lenses should be adequate as long as the information 

10 applies to all of the lenses in the package, and as long as this package is what the 

11 person installing them into a product will be receiving. It would not be appropriate to 

12 only provide it on an outer package that would be expected to be removed by someone 

13 other than the person installing the lenses. 

14 Q20. I will be selling bulk quantities of coated lenses. Do my customers, who will be 

15 assembling the lenses into finished optical systems, need to include labeling or 

16 marking information as specified in 10 CFR 40.52(b)(4)?

17 A20. No. Licenses for distribution are only required for initial transfer for sale or distribution; 

18 as long as your customers operate within the constraints of the exemption, no 

19 requirements apply to them. 

20 Q21. I am distributing imported finished optical systems. Does the product I am 

21 initially transferring for sale or distribution require labeling? 

22 A21. Yes. The identity of the manufacturer or your company’s name as the distributor and the 

23 fact that thorium or uranium is present should, at a minimum, appear on the point-of-sale 

24 packaging. 

25 Q22. In 10 CFR 40.13(c)(6)(ii), the NRC specifies that the uranium shipping container 

26 must be encased in mild steel or equally fire-resistant metal. What is “mild 

27 steel?” What other metal is acceptable? 

28 A22. Mild steel is an iron-carbon alloy typically with a maximum of 0.25 percent carbon. It is 

29 the most common form of steel because it provides material properties that are 

30 acceptable for many applications. Its noncombustible property makes it effective as an 

31 encasement for the uranium in shipping containers. Other noncombustible metal 

32 alternatives, including stainless steel, are also commonly used in shipping containers. 
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1 Q23. I was planning to import finished lenses that have a thorium coating and to 

2 assemble the lenses into gun scopes, binoculars, telescopes, and similar items. 

3 Do I need a specific license to assemble the coated lenses into my products? 

4 A23. No. As a result of the exemption granted in 10 CFR 40.13(c)(7), you would not need a 

5 specific license to possess the lenses and assemble them into gun scopes, binoculars, 

6 telescopes, and similar items. However, unless the company providing you the lenses 

7 distributed them under a 10 CFR 40.52 license, if you plan to sell or distribute the lenses 

8 to others, you will need to obtain a license from the NRC under 10 CFR 40.52 because 

9 you would be the first person transferring the lenses domestically. The lenses may not 

10 be used in eyepieces (i.e., lenses in close proximity to the eye when in use) in binoculars 

11 or in other optical instruments. Also, uranium and thorium may not be used or contained 

12 in spectacles or in contact lenses. 

13 The exemption in 10 CFR 40.13(c)(7) does not allow for the shaping, grinding, or 

14 polishing of such lenses or for manufacturing processes other than assembly into an 

15 optical instrument. If smoothing involves grinding or polishing, it is prohibited under the 

16 exemption, and instead, a specific NRC or Agreement State license would be required to 

17 conduct these activities. 

18 Q24. If I have the required distribution license issued under 10 CFR 40.52 and transfer 

19 my product for use under an exemption, and a recipient uses or modifies the 

20 product in ways that make the product no longer eligible for possession under an 

21 exemption, do I have any associated liability? 

22 A24. An initial distributor for source material is required to transfer the product in accordance 

23 with the requirements in 10 CFR 40.51. If you transferred a product that meets the 

24 conditions of the applicable exemption to a recipient that is authorized to receive the 

25 source material under an exemption from licensing, then you have met your obligations. 

26 If the recipient subsequently uses or modifies the product in a way that is inconsistent 

27 with the exemption or contrary to other regulations, the recipient would be solely 

28 responsible. In some cases, such use by the recipient may be covered by the general 

29 license in 10 CFR 40.22; however, the recipient should realize that if they further 

30 distribute a modified product (and its final form once again meets the requirements for 

31 possession under the original or another exemption), the recipient would need to obtain 

32 a specific license under 10 CFR 40.52 for initial distribution of the modified product. 

33 Q25. For the reports required to be submitted under 10 CFR 40.53(c), what level of 

34 precision is expected for the information required by 10 CFR 40.53(c)(3)? Does 

35 each item identified in 10 CFR 40.53(c)(3)(ii) have to be assessed individually or 

36 can an applicant provide alternative verifications and indicate that the amount of 

37 source material was below the percentage or quantity limit? Should the reporting 

38 units be weight percent (i.e., ppm) or activity (i.e., Ci or Bq)? 

39 A25. Simply providing information that the source material was below a concentration or 

40 quantity limit would not be acceptable. The better the characterization that can be 

41 provided by the distributor, the better the NRC will be able to refine its estimates of 

42 impacts to the public from exempt products in the future. However, the intent is not to 

43 require additional sampling or any significant analysis that is not already performed. The 

44 form of the information that is appropriate will vary for the type of product. Nominal 

45 values for specific products and total quantity of source material distributed in those 
F–7 

1 products may be adequate. If products can be categorized by type, one approach would 

2 be to give the range of source material content for each type and provide the total 

3 quantity for each type distributed. While information on weight percent may be provided, 

4 total weight would also be needed to meet the requirement of reporting the total quantity 

5 of source material in each type of product. The reporting requirement does not specify 

6 the units, so distributors may report in whatever units they are currently keeping records.

1 APPENDIX G 

2 SAFETY CULTURE POLICY STATEMENT 

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1 Safety Culture 

2 The safety culture policy statement was published in the Federal Register (76 FR 34773) on 

3 June 14, 2011, and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/ 

4 2011-14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission’s (NRC’s) 

5 Agencywide Documents Access and Management System, Accession No. 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. 
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1 The following are traits of a positive safety culture: 

2 (1) Leadership Safety Values and Actions – Leaders demonstrate a commitment to safety in 

3 their decisions and behaviors; 

4 (2) Problem Identification and Resolution – Issues potentially impacting safety are promptly 

5 identified, fully evaluated, and promptly addressed and corrected commensurate with 

6 their significance; 

7 (3) Personal Accountability – All individuals take personal responsibility for safety; 

8 (4) Work Processes – The process of planning and controlling work activities is 

9 implemented so that safety is maintained; 

10 (5) Continuous Learning – Opportunities to learn about ways to ensure safety are sought 

11 out and implemented; 

12 (6) Environment for Raising Concerns – A safety-conscious work environment is maintained 

13 where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

14 harassment, or discrimination; 

15 (7) Effective Safety Communication – Communications maintain a focus on safety; 

16 (8) Respectful Work Environment – Trust and respect permeate the organization; and 

17 (9) Questioning Attitude – Individuals avoid complacency and continuously challenge 

18 existing conditions and activities in order to identify discrepancies that might result in 

19 error or inappropriate action. 

20 There may be traits not included in this Statement of Policy that are also important in a positive 

21 safety culture. It should be noted that these traits were not developed to be used for 

22 inspection purposes. 

23 It is the Commission’s expectation that all individuals and organizations, performing or 

24 overseeing regulated activities involving nuclear materials, should take the necessary steps to 

25 promote a positive safety culture by fostering these traits as they apply to their organizational 

26 environments. The Commission recognizes the diversity of these organizations and 

27 acknowledges that some organizations have already spent significant time and resources in the 

28 development of a positive safety culture. The Commission will take this into consideration as 

29 the regulated community addresses the Statement of Policy.
1 APPENDIX H 

2 CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

3 INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)

H–1 

1 Checklist for Requests to Withhold Proprietary Information From Public 

2 Disclosure (Under 10 CFR 2.390) 

In order to request that the U.S. Nuclear Regulatory Commission (NRC) withhold information 

from public disclosure, the applicant or licensee must submit the information, including an 

affidavit, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390, “Public 

Inspections, Exemptions, Requests for Withholding.” The applicant should submit all of the 

following: 

 A proprietary copy of the information. Brackets should be placed around the material 

considered to be proprietary. This copy should be marked as proprietary. 

 A non-proprietary copy of the information. Applicants should white out or black out the 

proprietary portions (i.e., those in the brackets), leaving the non-proprietary portions 

intact. This copy should not be marked as proprietary. 

 An affidavit that: 

 Is signed under oath and affirmation (notarization may suffice). 

 Clearly identifies (such as by name or title and date) the document to be withheld. 

 Clearly identifies the position of the person executing the affidavit. This person 

must be an officer or upper-level management official who has been delegated the 

function of reviewing the information the organization is seeking to withhold and is 

authorized to apply for withholding on behalf of the organization. 

 States that the organization submitting the information is the owner of the 

information or is required, by agreement with the owner of the information, to treat 

the information as proprietary. 

 Provides a rational basis for holding the information in confidence. 

 Fully addresses the following issues: 

 Is the information submitted to, and received by, the NRC in confidence? 

Provide details. 

 To the best of the applicant’s knowledge, is the information currently available in 

public sources? 

 Does the applicant customarily treat this information, or this type of information, 

as confidential? Explain why. 

 Would public disclosure of the information be likely to cause substantial harm to 

the competitive position of the applicant? If so, explain why in detail. The 

explanation should include the value of the information to your organization, the 

amount of effort or money expended in developing the information, and the 

ease or difficulty for others to acquire the information. 







NUREG-1556, Vol. 8

Revision 1, Draft

Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Exempt Distribution Licenses