Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

Possession Licenses for Manufacturing 

and Distribution

Final Report 

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 12, Rev. 1
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those of the NRC.

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DISCLAIMER: This report was prepared as an account of 

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SR-CR 10/2017
Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

Possession Licenses for Manufacturing

and Distribution

Final Report

Manuscript Completed: May 2018

Date Published: May 2018

Prepared by:

D. Lawyer

T. Thompson

C. Frazier

M. Simmons

L. Sepulveda

D. Samson

Office of Nuclear Material Safety and Safeguards 

NUREG-1556

Volume 12, Rev. 1

iii

ABSTRACT

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

assist applicants and licensees in preparing applications for manufacturing and distribution 

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

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

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

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

if the proposed activities are acceptable for licensing purposes. 

Paperwork Reduction Act Statement

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

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

by the Office of Management and Budget (OMB), approval numbers 3150-0001, 3150-0008, 

3150-0009, 3150-0010, 3150-0014, 3150-0016, 3150-0017, 3150-0020, 3150-0035, 3150-0044, 

3150-0120, 3150-0158, and 3150-0214. Send comments regarding this information collection 

to the Information Services Branch, U.S. Nuclear Regulatory Commission, Washington, DC 

20555-0001, or by e-mail to Infocollects.Resource@nrc.gov, and to the Desk Officer, Office 

of Information and Regulatory Affairs, NEOB-10202, (3150-0001, 3150-0008, 3150-0009, 

3150-0010, 3150-0014, 3150-0016, 3150-0017, 3150-0020, 3150-0035, 3150-0044, 3150-0120, 

3150-0158, and 3150-0214) Office of Management and Budget, Washington, DC 20503.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to, a collection 

of information unless the document requesting or requiring the collection displays a currently 

valid OMB control number.

v

FOREWORD

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

a comprehensive source of reference information about various aspects of materials licensing

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

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

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

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

Volume No. Volume Title

1 Program-Specific Guidance About Portable Gauge Licenses

2 Program-Specific Guidance About Industrial Radiography Licenses

3 Applications for Sealed Source and Device Evaluation and Registration

4 Program-Specific Guidance About Fixed Gauge Licenses

5 Program-Specific Guidance About Self-Shielded Irradiator Licenses

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

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

Other Licenses of Limited Scope Including Electron Capture Devices and 

X-Ray Fluorescence Analyzers

8 Program-Specific Guidance About Exempt Distribution Licenses

9 Program-Specific Guidance About Medical Use Licenses

10 Program-Specific Guidance About Master Materials Licenses

11 Program-Specific Guidance About Licenses of Broad Scope

12 Program-Specific Guidance About Possession Licenses for Manufacturing 

and Distribution

13 Program-Specific Guidance About Commercial Radiopharmacy Licenses

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

Study Licenses

15 Guidance About Changes of Control and About Bankruptcy Involving 

Byproduct, Source, or Special Nuclear Materials Licenses

16 Program-Specific Guidance About Licenses Authorizing Distribution to 

General Licensees

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

Critical Mass Licenses

18 Program-Specific Guidance About Service Provider Licenses

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

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

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

to Work in Agreement State Jurisdiction (Reciprocity)

20 Guidance About Administrative Licensing Procedures

21 Program-Specific Guidance About Possession Licenses for Production of 

Radioactive Material Using an Accelerator

The current document, NUREG–1556, Volume 12, Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Possession Licenses for Manufacturing 

and Distribution,” is intended for use by applicants, licensees, and NRC Staff. This revision 

provides a general update to the previous information contained in NUREG–1556, Volume 12, 

issued December 2000. 
vi

This report takes a risk-informed, performance-based approach to licensing the possession and 

use of radioactive material for manufacturing and distribution. A team composed of staff from 

NRC Headquarters, NRC regional offices, and Agreement States prepared this document, 

drawing on their collective experience in radiation safety in general and as specifically applied to 

licenses authorizing possession for manufacturing and distribution.

NUREG–1556, Volume 12, Revision 1, is not a substitute for NRC or Agreement State 

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

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

the different methods include a basis for the staff to make the determinations needed to issue or 

renew a license.

The comments received during the public comment period for NUREG–1556, Volume 12, 

Revision 1, were summarized and addressed in a document that can be located on the NRC’s 

Agencywide Documents and Management System (ADAMS) under ML18010B155. Access to 

ADAMS is available on the public Web site at: https://www.nrc.gov/reading-rm/adams.html. 

The comments received by NRC included general corrections, comments on sources and 

devices containing byproduct material, and comments on security of nuclear materials.

_______________________________________

Daniel S. Collins, Director

Division of Materials Safety, Security, State, and Tribal Programs

Office of Nuclear Material Safety and Safeguards
vii

TABLE OF CONTENTS

ABSTRACT...............................................................................................................................iii

FOREWORD ..............................................................................................................................v

FIGURES...................................................................................................................................xi

TABLES ....................................................................................................................................xi

ACKNOWLEDGMENTS..........................................................................................................xiii

ABBREVIATIONS ....................................................................................................................xv

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8.5.1 Sealed Sources and Devices or Unsealed Radioactive Material.........8-4

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

8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used........................8-12

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

Their Training and Experience ...........................................................8-17

8.7.1 Radiation Safety Officer....................................................................8-18

8.7.2 Authorized Users..............................................................................8-21

8.8 Item 8: Training for Individuals Working in or Frequenting

Restricted Areas ................................................................................8-23

8.9 Item 9: Facilities and Equipment ....................................................................8-24

8.10 Item 10: Radiation Safety Program ................................................................8-28

8.10.1 Audit and Review of Program ...........................................................8-28
viii

8.10.2 Radiation Monitoring Instruments .....................................................8-29

8.10.3 Material Receipt and Accountability..................................................8-31

8.10.4 Occupational Dose ...........................................................................8-39

8.10.5 Public Dose ......................................................................................8-43

8.10.6 Safe Use of Radionuclides and Emergency Procedures...................8-44

8.10.7 Surveys and Leak Tests ...................................................................8-49

8.10.8 Maintenance.....................................................................................8-53

8.10.9 Transportation ..................................................................................8-54

8.10.10 Security Program for Category 1 and Category 2 

Radioactive Material .........................................................................8-56

8.11 Item 11: Waste Management .........................................................................8-57

8.12 Item 12: License Fees....................................................................................8-65

8.13 Item 13: Certification......................................................................................8-65

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

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

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

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

APPENDICES

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

APPENDIX B SUGGESTED FORMAT FOR PROVIDING INFORMATION 

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

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

APPENDIX C LICENSE TYPES–GUIDANCE................................................................. C–1

APPENDIX D RADIATION SAFETY OFFICER DUTIES AND RESPONSIBILITIES ...... D–1

APPENDIX E RADIATION SAFETY TRAINING ............................................................. E–1

APPENDIX F FACILITIES AND EQUIPMENT.................................................................F–1

APPENDIX G SAMPLE AUDIT PROGRAM....................................................................G–1

APPENDIX H RADIATION MONITORING INSTRUMENT SPECIFICATIONS

AND MODEL RADIATION SURVEY INSTRUMENT 

CALIBRATION PROGRAM...................................................................... H–1

APPENDIX I MATERIAL RECEIPT AND ACCOUNTABILITY ........................................I–1

APPENDIX J GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL MEMBERS

OF THE PUBLIC WILL NOT RECEIVE DOSES EXCEEDING THE 

ALLOWABLE LIMITS................................................................................J–1

APPENDIX K GENERAL TOPICS FOR SAFE POSSESSION AND USE OF 

RADIOACTIVE MATERIALS AND MODEL EMERGENCY 

PROCEDURES......................................................................................... K–1

APPENDIX L TYPICAL U.S. NUCLEAR REGULATORY COMMISSION (NRC) 

NOTIFICATION AND REPORTING REQUIREMENTS

FOR INCIDENTS .......................................................................................L–1

APPENDIX M RADIATION SAFETY SURVEY TOPICS..................................................M–1

APPENDIX N MODEL LEAK TEST PROGRAM............................................................. N–1

APPENDIX O U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS.............. O–1

APPENDIX P MODEL WASTE MANAGEMENT PROCEDURES................................... P–1

APPENDIX Q SAFETY CULTURE POLICY STATEMENT .............................................Q–1
ix

APPENDIX R MEDICAL DISTRIBUTION ....................................................................... R–1

APPENDIX S CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

INFORMATION FROM PUBLIC DISCLOSURE

(UNDER 10 CFR 2.390)............................................................................ S–1

xi

FIGURES

Figure Page

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

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

8-2 Methods of Providing Financial Assurance for Decommissioning ............................8-10

8-3 Records Important to Decommissioning ..................................................................8-11

8-4 Example of a Product Produced Under Possession for Manufacturing and

Distribution Authorization.........................................................................................8-16

8-5 Typical Duties and Responsibilities of RSOs ...........................................................8-19

8-6 Diagram Showing Information Related to Radiation Safety .....................................8-27

8-7 Material Receipt and Accountability.........................................................................8-35

8-8 Annual Dose Limits for Adult Radiation Workers .....................................................8-40

8-9 Calculating Public Dose...........................................................................................8-44

8-10 Use of Appropriate Shielding ...................................................................................8-46

8-11 Types of Surveys.....................................................................................................8-49

8-12 Personnel Surveys ..................................................................................................8-50

8-13 Air and Water Effluents from a Manufacturing Facility..............................................8-60

K–1 Storage of Food and Drink........................................................................................K-1

M–1 Laboratory Layout.....................................................................................................M-7

TABLES

Table Page

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

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

8-1 Sample Format for Providing Information About Requested Radionuclides ................8-13

8-2 Package Monitoring Requirements.............................................................................8-33

8-3 Record Maintenance. .................................................................................................8-37

8-4 Guidance on Personnel Monitoring and Bioassay ......................................................8-41

B–1 License Reviewer Checklist........................................................................................ B–1

J–1 Standard Occupancy Factors .......................................................................................J-4

L–1 Typical NRC Notification and Reporting Requirements for Incidents ...........................L–1

M–1 Suggested Contamination Survey Frequency ............................................................M–3

M–2 Acceptable Surface Contamination Levels for Equipment...........................................M–4

M–3 Screening Values for Building Surface Contamination................................................M–6

xiii

ACKNOWLEDGMENTS

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

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

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

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

technical information that assisted in the development of this report. The working group thanks 

Tomas Herrera for the pivotal role that he played in the development of this report.

The Participants for this Revision

Frazier, Cassandra

Lawyer, Dennis

Samson, Daniel

Sepulveda, Lymari

Simmons, Michelle

Thompson, Thomas

xv

ABBREVIATIONS

ADAMS Agencywide Document Access and Management System

AEA Atomic Energy Act

ALARA as low as is reasonably achievable

ALI annual limit on intake

ANSI American National Standards Institute

AU authorized user

bkg background

Bq becquerel

C-14 carbon-14

Ci curie 

CFR Code of Federal Regulations

cpm counts per minute

DAC derived air concentration

DFP decommissioning funding plan

DIS decay-in-storage

DOE U.S. Department of Energy

DOT U.S. Department of Transportation

dpm disintegrations per minute

EA environmental assessment

ECD electron capture devices 

EDE effective dose equivalent

EPA U.S. Environmental Protection Agency

EPAct Energy Policy Act

FA financial assurance

FDA U.S. Food and Drug Administration

Fe-59 iron-59

FR Federal Register

GBq gigabecquerel

Gy Gray

h hour

I-125 iodine-125

I-131 iodine-131

IAEA International Atomic Energy Agency

IN information notice

L/C license condition

LLEA local law enforcement agency

LLW low-level radioactive waste

LSA low specific activity

LSC liquid scintillation counting

MARSSIM Multi-Agency Radiation Survey and Site Investigation Manual

mBq millibecquerel

mCi millicurie

MDA minimum detectable activity

mR milliroentgen

mrem millirem

mSv millisievert

NaI(Tl) sodium iodide crystal doped with thallium

NCRP National Council on Radiation Protection and Measurements

ND not detectable
xvi

NMSS Office of Nuclear Material Safety and Safeguards

NORM naturally occurring radioactive material

NR not required

NRC U.S. Nuclear Regulatory Commission

NSTS National Source Tracking System

NSTTR National Source Tracking Transaction Report

NVLAP National Voluntary Laboratory Accreditation Program

OMB Office of Management and Budget

OSHA Occupational Safety and Health Administration

PII personally identifiable information 

QA quality assurance

R roentgen

Ra-226 radium-226

RG regulatory guide

RIS regulatory issue summary

RQ reportable quantities

RSO Radiation Safety Officer

Se selenium-75

SI International System of Units (abbreviated SI from the French “Systeme 

Internationale d’Unites”)

SSD Sealed Source and Device [registration certificate]

std standard

Sv sievert

TEDE total effective dose equivalent

TI transportation index

μGy microGray

U.S.C. United States Code

UN United Nations
1-1

1 PURPOSE OF REPORT

This report provides guidance to an applicant applying for several types of licenses associated 

with the manufacturing and distribution of radioactive materials and products containing 

radioactive materials and also provides the U.S. Nuclear Regulatory Commission (NRC) staff 

with the criteria for evaluating such applications. This NUREG uses the terms “byproduct 

material,” “licensed material,” and “radioactive material” interchangeably.

This report addresses the variety of radiation safety issues associated with manufacturing and 

distribution. This NUREG provides guidance to applicants preparing a license application for 

possession and use for manufacturing and distribution or an application for possession 

incident to distribution only. Because some licensees subject to this report possess aggregated 

Category 1 or Category 2 quantities of radioactive material subject to Title 10 of the Code of 

Federal Regulations (10 CFR) Part 37, this NUREG additionally addresses security 

requirements associated with possession of that material. Appendix R of this NUREG

provides guidance for the distribution and transfer of radioactive drugs, sealed sources, 

and devices directly to medical-use licensees by nonradiopharmacy entities. This guidance 

does not apply to those quantities of special nuclear material exceeding those listed in 

10 CFR 70.22(h)(2)(i)(1). 

For the purpose of this NUREG, manufacturers and distributers are those licensees that 

process raw material and/or sources and distribute those processed materials or manufactured 

products to users as finished products. Examples include major radiopharmaceutical 

processor/manufacturers (not radiopharmacies), sealed source fabricators, device 

manufacturers, and other manufacturing licensees that possess and use irradiated bulk 

quantities of raw materials or sources.

Distribution-only licensees are not involved in the processing of raw materials or sources or in 

the manufacturing of devices. Normally, imported products require a distribution and 

possession license to enable imported products to be distributed within the U.S. states 

and territories.

Quality control for finished products are described in the regulations of 10 CFR Part 32. The 

distribution of materials to persons exempt from licensing and distribution of materials to 

generally licensed persons and additional quality control guidance for these products are 

described in NUREG–1556, Vol. 8, “Consolidated Guidance About Materials Licensees:

Program-Specific Guidance About Exempt Distribution Licenses” and NUREG–1556, Vol. 16, 

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

Authorizing Distribution to General Licensees.”

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

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

the possession and use of byproduct, source, and special nuclear materials for manufacturing 

and distribution, and for distribution (only) for medical use (not radiopharmacies). If a license of 

broad scope is being sought under 10 CFR Part 33, “Specific domestic licenses of broad scope 

for byproduct material”, also refer to NUREG–1556, Vol. 11, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope.” The Office 

of Management and Budget has approved the information collection requirements in 

Title 10 CFR Part 30, Part 32, Part 40, Part 70, and NRC Form 313 under the Clearance 

Nos. 3150-0017, 3150-0001, 3150-0020, 3150-0009, and 3150-0120, respectively.
1-2

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

• Regulations—references the regulations applicable to the item.

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

• Discussion—provides additional information about the topic.

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

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

licensing process.

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

NRC Form 313. Sentences in this NUREG containing “must” and “will” are usually associated 

with NRC regulations. If these sentences are not tied to a regulatory requirement, they likely 

refer to a license condition or other obligation associated with the license. See NUREG–1556, 

Volume 20, “Consolidated Guidance About Materials Licenses: Guidance About Administrative 

Licensing Procedures,” for further information on license conditions.

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

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

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

convenience and streamlined handling of applications, Appendix B of this NUREG, “Suggested 

Format for Providing Information Requested in Items 5 through 11 of the NRC Form 313,” may 

be used to provide supporting information.

Appendices C through S of this NUREG contain additional information on various radiation 

safety topics. Appendix C of this NUREG provides information on the types of licenses. 

Appendix R of this NUREG provides guidance in applying for distribution (only) to medical 

use licensees.

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

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

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

against radiation.” To describe units of radiation exposure or dose, rem and its International 

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

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

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

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

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

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

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

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

and neutrons.
2-1

2 AGREEMENT STATES

2.1 Jurisdiction Determination

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

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

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

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

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

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

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

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

regulatory authority.

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

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

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

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

recognized Indian Tribes.2

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

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

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

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

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

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

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

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

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

regulatory authority.

Table 2-1. Who Regulates the Activity?

Applicant and Proposed Location of Work

Regulatory 

Agency

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

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

from licensing, in accordance with 10 CFR 30.12, “Persons using 

byproduct material under certain Department of Energy and Nuclear 

Regulatory Commission contracts”; also, see 10 CFR 40.11, and/or 

10 CFR 70.11, 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

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

 

2For 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.

3The 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.

4Section 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.
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Table 2-1. Who Regulates the Activity?

Applicant and Proposed Location of Work

Regulatory 

Agency

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

subject to exclusive Federal jurisdiction Agreement State4

Non-Federal entity in Agreement State at Federally controlled site subject 

to exclusive Federal jurisdiction NRC

Non-Federal entity in Agreement State using radioactive materials 

(except industrial radiography) directly connected with 10 CFR Part 50 or 

52 reactor operations or needed during the construction and 

preoperational phases of a reactor

NRC

Non-Federal entity in Agreement State using radioactive materials not 

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

needed during the construction and preoperational phases of a reactor

Agreement State4

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

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

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

2.2 Reciprocal Recognition of Specific Licenses

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

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

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

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

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

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

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

in advance of the scheduled use of licensed material. 

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

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

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

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

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

be renewed annually.

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

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

are provided in NUREG–1556, Volume 19, “Consolidated Guidance About Materials Licenses: 

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).”

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3 MANAGEMENT RESPONSIBILITY

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

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

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

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

and compliance.

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

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

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

3.1 Commitments and Responsibilities

Pursuant to Title 10 of the Code of Federal Regulations (10 CFR) 30.32(c), 10 CFR 40.31(b), 

and 10 CFR 70.22(d), each application must be signed by the applicant or licensee or a person 

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

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

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

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

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

responsibilities for the following:

• radiation safety, security, and control of radioactive materials and compliance 

with regulations

• completeness and accuracy of the radiation safety records and all information provided 

to the NRC (10 CFR 30.9, 40.9, and 70.9, “Completeness and accuracy of information”)

• knowledge about the contents of the license and application

• compliance with current NRC and U.S. Department of Transportation regulations,

the licensee’s operating, emergency, and security procedures, and NRC

license commitments

• commitment to provide adequate resources (including space, equipment, personnel, 

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

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

is maintained

• commitment to report defects, noncompliances, or reportable events, in accordance 

with regulations 

• selection and assignment of a qualified individual to serve as the Radiation Safety 

Officer (RSO) for licensed activities and confirmation that the RSO has independent 

authority to stop unsafe operations and will be given sufficient time to fulfill radiation 

safety duties and responsibilities

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

• prevention of discrimination of employees engaged in protected activities and 

commitment to provide information to employees about employee protection provisions 

(10 CFR 30.7, 40.7, and 70.7, “Employee protection”)

• commitment to provide information to employees about deliberate misconduct provisions 

(10 CFR 30.10, 40.10, and 70.10, “Deliberate misconduct”)

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

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

• notification of the appropriate NRC regional administrator, in writing, immediately 

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

10 CFR 40.41(f), and 10 CFR 70.32(a)(9)], as discussed further in Section 8.2.1, 

“Notification of Bankruptcy Proceedings,” of this NUREG

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

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

the NRC’s online library at https://www.nrc.gov/reading-rm.html.

3.2 Safety Culture

Individuals and organizations performing regulated activities are expected to establish and 

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

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

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

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

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

subject to NRC authority.

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

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

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

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

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

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

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

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

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

from NRC’s safety culture policy statement.

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

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

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

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

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

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

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

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

with NRC-regulated activities.
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The NRC, as the regulatory agency with an independent oversight role, reviews the 

performance of individuals and organizations to determine compliance with requirements and 

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

safety culture policy statement and traits are not incorporated into the regulations. Many of the 

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

programs. For instance, manufacturers and distributors develop production and quality 

assurance procedures for providing goods to others may correlate with the safety culture trait 

specified in Table 3-1 as “Work Processes” (the process of planning and controlling work 

activities to ensure that safety is maintained). However, licensees should be aware that this is 

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

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

organizations and functions.

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

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

https://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 

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4 APPLICABLE REGULATIONS

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

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

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

Federal Regulations (10 CFR) contain regulations applicable to licenses associated with the 

manufacturing and distribution of radioactive materials and products containing radioactive 

materials. Some of these parts are specific to one type of license, while others are general and 

will apply to many, if not all, licensees.

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

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

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

links to the rules:

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

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

and Investigations”

• 10 CFR Part 20 “Standards for Protection Against Radiation”

• 10 CFR Part 21 “Reporting of Defects and Noncompliance”

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

Byproduct Material”

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

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

Items Containing Byproduct Material

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

Byproduct Material”

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

Radioactive Material”

• 10 CFR Part 40 “Domestic Licensing of Source Material”

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

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

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

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

Other Regulatory Services Under the Atomic Energy Act of 1954,

as Amended”
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• 10 CFR Part 171 “Annual Fees for Reactor Licenses and Fuel Cycle Licenses and

Materials Licenses, Including Holders of Certificates of

Compliance, Registrations, and Quality Assurance Program 

Approvals and Government Agencies Licensed by the NRC”

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

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

202-512-1800; or ordering online at https://bookstore.gpo.gov. 

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

https://www.nrc.gov/reading-rm/doc-collections/ under Regulations (10 CFR). 

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

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

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

Federal Register.
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5 HOW TO FILE

5.1 Application Preparation

Applicants for a materials license should do the following:

• Use the most recent guidance in preparing an application.

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

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

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

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

Appendix B of this NUREG.

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

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

minimize danger to life and property.

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

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

application or the topic to which it refers.

• Avoid submitting proprietary information and personally identifiable information. If 

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

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

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

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

5.2 Where to File

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

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

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

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

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

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

to Region I.

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

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

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

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

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

States,” for additional information.
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5.3 Paper Applications

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

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

applicants should do the following:

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

into a document scanner.

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

• Use 11-point or larger font.

• Avoid stylized characters, such as script or italics.

• Ensure that the print is clear and sharp.

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

is best).

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

by 10 CFR 30.32(c), 40.31(b), and 70.22(d) (see Section 8.13, “Certification”).

5.4 Electronic Applications

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

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

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

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

signatures, and the treatment of non-public information.
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6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION

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

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

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

www.nrc.gov.

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

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

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

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

examples are as follows:

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

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

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

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

checklist for requests for withholding proprietary information from public disclosure.

• Personally Identifiable Information: Personally identifiable information (PII) about 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

“Security-Related Information—Withhold under 10 CFR 2.390.” For the pages having 

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

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

Rev. 1, “Control of Security-Related Sensitive Unclassified Non-Safeguards Information 

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

Source, Byproduct, and Special Nuclear Material,” dated December 26, 2017, which can 

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

Summaries”: https://www.nrc.gov/reading-rm/doc-collections/gen-comm/. 
6-2

Additional information on procedures and any updates is available at 

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

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

These include

• trade secrets and commercial or financial information

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

party other than an agency in litigation with NRC

• certain records or information compiled for law enforcement purposes

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

concerning wells

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

clearly unwarranted invasion of personal privacy

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

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

regulation is available electronically on the NRC Web site: https://www.nrc.gov/reading-rm/doccollections/cfr. 

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

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

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

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

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

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

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

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

proprietary status of the information.

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

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

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

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

Management Directive 12.6 is available electronically on the NRC Web site: 

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

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

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

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

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

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

signed the appropriate agreements for handling proprietary information.

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

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

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

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

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

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

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

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

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

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

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

information from public disclosure.

7-1

7 APPLICATION AND LICENSE FEES

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

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

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

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

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

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

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

disposition of an application or the withdrawal of an application.

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

materials licensees, holders of certificates of compliance, holders of sealed source and device

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

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

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

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

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

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

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

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

extension 415-7554. The e-mail address is Fees.Resource@nrc.gov.

8-1

8 CONTENTS OF AN APPLICATION

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

this NUREG).

All items in the application should be completed in enough detail for the U.S. Nuclear 

Regulatory Commission (NRC) to determine whether the proposed equipment, facilities, training 

and experience, and radiation safety program satisfy regulatory requirements and are adequate 

to protect public health and safety and minimize danger to life and property. Consideration 

should be given, when developing the application, to the concepts of keeping exposure as low 

as is reasonably achievable (ALARA), minimizing contamination, and maintaining control of 

radioactive materials.

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

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

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

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

for Maintaining Occupational Radiation Exposures as Low as Is Reasonably Achievable,” 

discusses the ALARA concept and philosophy. The application should document ALARA 

considerations, including establishing administrative action levels and monitoring programs.

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

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

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

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

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

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

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

material not in storage.”

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

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

8.1 Item 1: License Action Type

Item 1 of NRC Form 313 states the following:

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

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

issuance of the license. Also note that an initial on-site security review may be conducted in 

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

issuance of the license.
8-2

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

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

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

8.2 Item 2: Name and Mailing Address of Applicant

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

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

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

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

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

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

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

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

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

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

Bankruptcy Proceedings”). 

8.2.1 Notification of Bankruptcy Proceedings

Regulation: 10 CFR 30.34(h); 10 CFR 40.41(f)(1); 10 CFR 70.32(a)(9)(i)

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

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

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

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

subject to all applicable NRC regulatory requirements. The NRC must know when licensees are 

in bankruptcy proceedings in order to determine whether all licensed material is accounted for 

and adequately controlled and whether there are any public health and safety concerns 

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

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

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

Justice represent its interests in the bankruptcy proceeding.

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

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

involuntary petition for bankruptcy by or against the licensee.

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

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

Special Nuclear Materials Licenses.”
8-3

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

or Possessed

Regulations: 10 CFR 30.34(c); 10 CFR 40.41(c); 10 CFR 70.41(a)

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

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

facility at which licensed material will be used or stored. The descriptive address should be 

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

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

positioning system coordinates, as appropriate. 

If licensed material is to be possessed or possessed and used at more than one location, give 

the specific address of each location. Applicants for a broad scope license need not identify 

each facility at a particular address where licensed material will be possessed or possessed and 

used. For example, broad scope applicants can specify that licensed material will be possessed 

or possessed and used on the manufacturing campus of ABC Corporation located on 

Presidential Avenue in Anytown, State.

Figure 8-1. Location of Possession or Possession and Use. An acceptable location of 

use or possession specifies street address, city, State, and zip code and does 

not include a post office box number.

Applicants should identify all facilities designed or established for special uses (e.g., panoramic 

irradiators, interim or long-term waste storage facilities, high-activity laboratories, iodination 

facilities, alpha laboratories, and incinerators).

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

address or location not already listed on the license.

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

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

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

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

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

Protecting Sensitive Information,” for more details.
8-4

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

Decommissioning,” licensees must maintain permanent records that describe where licensed 

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

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

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

room numbers where licensed material is used or stored, and any records of leaking radioactive 

sources or other unusual occurrences involving the possible spread of contamination in or 

around the licensee’s facilities.

8.4 Item 4: Person To Be Contacted About This Application

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

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

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

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

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

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

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

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

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

also the RSO. 

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

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

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

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

8.5 Item 5: Radioactive Material

8.5.1 Sealed Sources and Devices or Unsealed Radioactive Material

Regulations: 10 CFR 20.2207; 10 CFR 30.6; 10 CFR 30.11; 10 CFR 30.32; 10 CFR 30.33; 

10 CFR 30.36; 10 CFR 30.37; 10 CFR 30.38; 10 CFR 30.72; 10 CFR 32.11; 10 CFR 32.14;

10 CFR 32.18; 10 CFR 32.21; 10 CFR 32.22; 10 CFR 32.26; 10 CFR 32.30; 10 CFR 32.51;

10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71; 10 CFR 32.72; 10 CFR 32.74;

10 CFR 32.210; 10 CFR Part 33; 10 CFR Part 37; 10 CFR 40.13; 10 CFR 40.31; 10 CFR 40.32; 

10 CFR 40.34; 10 CFR 40.35; 10 CFR 40.36; 10 CFR 40.38; 10 CFR 40.41; 10 CFR 40.44;

10 CFR 51.20; 10 CFR 51.21; 10 CFR 51.22; 10 CFR 70.22; 10 CFR 70.39; 10 CFR 70.40;

10 CFR 70.41; 10 CFR 110.9; 10 CFR 110.9a; 10 CFR 110.31; 10 CFR 110.32; 10 CFR 150.7

Criteria: An application for a specific license will be approved if the requirements of

10 CFR 30.33, 10 CFR 40.32, 10 CFR 51.20, 10 CFR 70.39, 10 CFR 110.31, and/or

10 CFR 110.32 are met. In addition, licensees will be authorized to possess and use only those 

sealed sources and devices that are specifically approved or registered by NRC or an 

Agreement State pursuant to 10 CFR 32.210 or equivalent Agreement State regulations.

Licensees must also protect aggregated Category 1 and Category 2 quantities of radioactive 

material, as defined in 10 CFR 37.5, from theft, diversion, and sabotage.
8-5

Discussion:

Materials That Must Be Listed in the Application

Each authorized radionuclide is listed on the NRC license by its element name, chemical and/or 

physical form, and the maximum possession limit (see Table 8-1). If a license of broad scope is 

being sought (under 10 CFR Part 33, “Specific domestic licenses of broad scope for byproduct 

material”), also refer to NUREG–1556, Vol. 11, “Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About Licenses of Broad Scope.”

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

{e.g., carbon-14 [C-14]} in Item 5. It is necessary to specify whether the material will be 

acquired and possessed and used in unsealed or sealed form. The name of the specific 

chemical compound that contains the radionuclide is not required. For potentially volatile 

radioactive material, however, it is necessary to specify whether the requested radionuclide will 

be acquired in free (volatile) or bound (nonvolatile) form because additional safety precautions 

are required when handling and using volatile material. For example, when requesting 

authorization to possess and use tritium (H-3) or iodine-125 (I-125), the applicant must specify 

whether the material will be acquired in free form or bound form. If a radionuclide will be 

acquired in both free and bound forms, then separate possession limits for each form must be 

requested by the applicant. The applicant must provide evidence (or information) that 

demonstrates that the material obtained will be nonvolatile. NRC may issue the license with 

separate or combined possession limits, depending on the reviewer’s analysis of the 

information provided.

Applicants requesting an authorization to possess and use volatile radioactive material must 

provide appropriate facilities, engineering controls, and radiation safety procedures for handling 

such material.

If an applicant plans to possess radioactive materials in excess of the quantities listed in 

10 CFR 30.72 (Schedule C), “Quantities of radioactive materials requiring consideration of the 

need for an emergency plan for responding to a release,” then they must provide with the 

application either (i) an evaluation showing that the maximum offsite dose because of a release 

of radioactive materials would not exceed 1 rem [0.01 Sievert (Sv)] effective dose equivalent or 

5 rem [0.05 Sv] to the thyroid, or (ii) an emergency plan for responding to the release in 

accordance with the criteria listed in 10 CFR 30.32(i)(3). Pursuant to 10 CFR 70.22(i)(1)(i)(ii), 

applicants who plan to possess greater than 2 curies of plutonium in unsealed form or on foils or 

plated sources must provide with the application either (i) an evaluation showing that the 

maximum dose to a member of the public offsite due to a release of radioactive materials would 

not exceed 1 rem [0.01 Sievert (Sv)] effective dose equivalent or (ii) an emergency plan for 

responding to the radiological hazards of an accidental release of special nuclear material and 

any associated chemical hazards directly incident thereto in accordance with the criteria listed in 

10 CFR 70.22(i)(3). Refer to Regulatory Guide 3.67, “Standard Format and Content for 

Emergency Plans for Fuel Cycle and Materials Facilities,” Revision 1, issued April 2011, for 

additional information on emergency plans.

Applicant should specify the anticipated possession limit in megabecquerels (MBq)

[millicuries (mCi)] or gigabecquerels (GBq) [curies (Ci)] for each radionuclide. Possession limits 

must cover the total anticipated inventory, including licensed material in storage and waste, and 

should be commensurate with the applicant’s needs and facilities for safe handling.
8-6

If materials are expected or requested to be returned from customers, then these materials must 

be factored into the inventory. Applicants should review the requirements for submitting a 

certification for financial assurance for decommissioning before specifying possession limits of 

any radionuclide with a half-life greater than 120 days. These requirements are discussed in 

Section 8.5.2, Financial Assurance and Decommissioning.

A safety evaluation of sealed sources and devices is performed by NRC or an Agreement State

before authorizing a manufacturer or distributor to distribute them. The safety evaluation is 

documented in a Sealed Source and Device (SSD) registration certificate. Before the 

formalization of the SSD registration process, some older sources or devices may have been 

specifically approved on a license. Licensees can continue to possess and use those sources 

and devices specifically listed on their licenses. Applicants must provide the manufacturer’s 

name and model number, as registered under 10 CFR 32.210 or similar Agreement State 

regulation, for each requested sealed source and device so that NRC can verify that they have

been evaluated in an SSD registration certificate or specifically approved on a license. See also 

NUREG–1556, Vol. 3, “Consolidated Guidance About Materials Licenses: Applications for 

Sealed Source and Device Evaluation and Registration.”

Licensees should consult with the proposed manufacturer or distributor to ensure that requested 

sources and devices are compatible with and conform to the SSD designations registered with

NRC or an Agreement State. Licensees may not make any changes to the sealed source, 

device, or source/device combination that would alter the description or specifications from 

those indicated in the respective registration certificates, without obtaining NRC’s prior 

permission in a license amendment. To ensure that sources and devices are possessed and 

used in accordance with the registration certificates, applicants and licensees should request a 

copy of the certificate from the manufacturer or distributor, review it, and discuss it with the 

manufacturer or distributor. If the manufacturer and distributor are no longer in service, a 

copy of the SSD registration certificate may be requested from the NRC or the issuing 

Agreement State. 

If a source is not listed in the SSD registry, applicants may be able to have the sources or 

devices authorized on a license under one of the following conditions:

• They submit all the information identified in 10 CFR 32.210 that is usually provided by 

the manufacturer when the source or device is registered. 

• The item was manufactured prior to October 23, 2012, and the applicant submits as 

much of the 10 CFR 32.210 information as known, and all the additional information 

listed in 10 CFR 30.32(g)(2) to assure that the source and/or device can be used safely. 

• The sealed source is a small calibration or reference source containing less than 1 mCi

[37 MBq] of a beta or gamma emitter or 10 microcuries [μCi] (0.37 MBq) of an alpha 

emitter that is not required to be registered pursuant to 10 CFR 30.32(g)(3) and 

32.210(g)(1).

• The applicant meets one of the criteria listed in 10 CFR 32.210(g)(2).

The submitted information will allow the NRC to conduct a case-by-case review to ensure that 

the material will not breach its containment. Material that is not registered in the SSD registry 

will be considered as unsealed until the applicant provides sufficient safety-related information 

that demonstrates that the source can be categorized as sealed. For additional guidance 

related to sealed sources and devices, see also NUREG–1556, Volume 3, “Consolidated 

Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation 

and Registration.”
8-7

For sealed sources and devices not registered, as allowed by 10 CFR 32.210(g)(2), the 

applicant must demonstrate that they have adequate training and experience and facilities and 

equipment to handle comparable quantities of material in other forms under 10 CFR 30.33(a)(2) 

and (3) and should propose constraints about unregistered sealed sources and devices, in 

accordance with 10 CFR 30.32(g)(4).

Applicant and licensee information on manufacturers, model numbers, and possession limits is 

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

Sensitive Information”).

Requests to license naturally occurring radioactive material (NORM) should be made to the 

appropriate regulatory agency. As a result of the Energy Policy Act of 2005 (EPAct), the NRC

and Agreement States through their agreements with the NRC, regulate discrete sources of

radium (Ra)-226, accelerator-produced radioactive materials, and other discrete sources of 

NORM that pose a threat similar to that of a discrete source of Ra-226, as described in the 

definition of byproduct material in 10 CFR 30.4. Notwithstanding the EPAct, most NORM 

continues to be regulated by the States. The NRC will only license NORM if it is a discrete 

source and meets the criteria above.

Applicants must provide the manufacturer’s name and model number, as registered under 

10 CFR 32.210 or similar Agreement State regulation, for each requested sealed source or 

device containing Ra-226 or accelerator produced radioactive material. For sources or devices 

containing naturally occurring or accelerator-produced radioactive material manufactured prior 

to November 30, 2007, that are not registered with the NRC or Agreement State, the applicant 

must provide the information required in 10 CFR 30.32(g)(3).

The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated “Category 1 

quantity of radioactive material” or “Category 2 quantity of radioactive material.” These terms 

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

are listed in Appendix A to 10 CFR Part 37. See Section 8.10.10, “Security Program for 

Category 1 and Category 2 Radioactive Material,” of this NUREG for more information on the 

applicability and requirements of 10 CFR Part 37.

Response from Applicant:

• For unsealed materials

— For each radionuclide, provide the element name with mass number, chemical 

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

• For potentially volatile materials (e.g., I-125, I-131, H-3, Kr-85)

— Specify whether the material will be free (volatile) or bound (nonvolatile) and the 

requested possession limit for each form.
8-8

• For sealed radioactive materials

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

and specify the maximum activity per source. Also, specify the maximum 

number of sources or total activity of each radionuclide.

— Provide the manufacturer’s or distributor’s name and model number for each 

sealed source and device requested.

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

registered as an approved sealed source or device by NRC or an 

Agreement State and will be possessed and used in accordance with the 

conditions specified in the registration certificate. Provide the SSD registration 

certificate number, if available.

o For each sealed source, device, and source and device combination that 

is not registered, provide the applicable information, as described in 

10 CFR 30.32(g) and 32.210.

• Identify the largest quantity of each radionuclide to be possessed at one time under the 

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

• In accordance with 10 CFR 30.32(i), applications to possess radioactive materials in 

unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities 

listed in 10 CFR 30.72 must include either of the following:

— an evaluation showing that the maximum offsite dose caused by a release of 

radioactive materials would not exceed 0.01 Sv [1 rem] effective dose equivalent 

or 0.05 Sv [5 rem] to the thyroid

— an emergency plan for responding to the release, in accordance with the criteria 

listed in 10 CFR 30.32(i)(3)

• In accordance with 10 CFR 70.22(i), applications to possess in excess of 2 Ci of

plutonium in unsealed form or on foils or plated sources must contain either of 

the following:

— an evaluation showing that the maximum dose to a member of the public offsite 

due to a release of radioactive materials would not exceed 0.01 Sv [1 rem] 

effective dose equivalent

— an emergency plan for responding to the radiological hazards of an accidental 

release of special nuclear material and any associated chemical hazards directly 

incident thereto, in accordance with the criteria listed in 10 CFR 70.22(i)(3)

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

copies of Regulatory Guide 3.67, “Standard Format and Content for Emergency Plans for Fuel 

Cycle and Materials Facilities.” Regulatory Guide 3.67 is available on NRC’s Web site at 

https://www.nrc.gov.
8-9

See also NUREG–1140, “A Regulatory Analysis on Emergency Preparedness for Fuel Cycle 

and Other Radioactive Material Licensees, Final Report,” January 1988 (ADAMS Accession 

No. ML062020791)

8.5.2 Financial Assurance and Recordkeeping for Decommissioning

Regulations: 10 CFR 30.32(h); 10 CFR 30.34(b); 10 CFR 30.35; 10 CFR 30.36(e); 

10 CFR 30.36(g)(4)(v); 10 CFR 30.51(d); 10 CFR 30.51(e); 10 CFR 30.51(f); 10 CFR 40.31(i); 

10 CFR 40.36; 10 CFR 40.41(b); 10 CFR 40.42(e); 10 CFR 40.42(g)(4)(v); 10 CFR 40.46; 

10 CFR 40.61(d); 10 CFR 40.61(e); 10 CFR 40.61(f); 10 CFR 70.22(a)(9); 10 CFR 70.25;

10 CFR 70.32(a)(3); 10 CFR 70.36; 10 CFR 70.38(e); 10 CFR 70.38(g)(4)(v); 10 CFR 70.51(a); 

10 CFR 70.51(b)(3).

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

10 CFR 30.35, 10 CFR 40.36, and/or 10 CFR 70.25—all titled “Financial assurance and 

recordkeeping for decommissioning”—must submit a decommissioning funding plan (DFP) or 

provide a certification of financial assurance (FA) for decommissioning.

All licensees are required to maintain records of information important to the decommissioning 

of the facility in an identified location until the site or any area is released for unrestricted use. 

Before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b), 

10 CFR 40.46, and/or 10 CFR 70.36, licensees must transfer records important to 

decommissioning to the new proposed licensee in accordance with 10 CFR 30.35(g), 

10 CFR 40.36(f) and/or 10 CFR 70.51(b)(3), respectively. Furthermore, before a license is 

terminated, the licensee must send records important to decommissioning that are 

required by 10 CFR 30.35(g), 10 CFR 40.36(f) and/or 10 CFR 70.25(g) to the appropriate 

NRC regional office in accordance with 10 CFR 30.51(f), 10 CFR 40.61(f), and/or 

10 CFR 70.51(a), respectively.

Discussion: NRC seeks to ensure that decommissioning will be carried out with minimum 

impact on public and occupational health and safety and the environment (53 FR 24018, 

June 28, 1988). There are two parts to the rule: financial assurance that applies to some

licensees; and recordkeeping, which applies to all licensees.

Financial Assurance

NRC regulations requiring an FA or a DFP are designed to provide reasonable assurance that 

the decommissioning of licensed facilities will be accomplished in a safe and timely manner and 

that licensees will provide adequate funds to cover all costs associated with decommissioning. 

These requirements, if applicable, specify that a licensee either set aside funds for 

decommissioning activities or provide a guarantee, through a third party, that funds will be 

available. Applicants are required to submit an FA or a DFP when the possession of radioactive 

material of half-life greater than 120 days exceeds certain limits. Criteria for determining 

whether an applicant is required to submit a DFP or has an option of submitting either a DFP or 

a certification of FA are stated in 10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25. A DFP 

contains a site-specific cost estimate and a certification of FA. A certification of FA includes a 

certification that the licensee has provided the required FA and an acceptable FA instrument.

Acceptable FA includes prepayment options (trusts, escrow accounts, government funds, 

certificates of deposit, or deposits of government securities); surety, insurance, or other 
8-10

guarantee methods (e.g., letters of credit, surety bonds, lines of credit, parent company 

guarantees, insurance policies); and statements of intent from Government entities. Criteria for 

parent company guarantees and self-guarantees can be found in 10 CFR 30, Appendix A, 

Appendix C, Appendix D, and Appendix E. Refer to 10 CFR 30.35(d) for a table of required 

amounts of financial assurance for decommissioning by quantity of material.

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

Recordkeeping, and Timeliness,” provides guidance acceptable to the NRC staff on the 

information to be provided for establishing financial assurance for decommissioning, a standard 

format for presenting the information, and information required to be submitted for a DFP. Note 

that FA is required for four types of licensed materials: (i) unsealed byproduct material, 

(ii) sealed byproduct material, (iii) dispersible source material, and (iv) unsealed special nuclear 

material. The total amount of FA required to be provided is the sum of the FA required for each 

of these types of materials.

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

Most manufacturer licensees do not need to provide financial assurance for decommissioning. 

Large manufacturers may need one of several approved financial mechanisms.

Recordkeeping for Decommissioning

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

information required, are stated in 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g). All 

licensees are required to maintain these records in an identified location until the site is released 

for unrestricted use. Careful recordkeeping of radionuclides used, including form, amount, and 

area used, will facilitate area release and license termination. In the event that the licensed 

activities are transferred to another person or entity, these records must be transferred to the 

new licensee before the transfer of the licensed activities takes place. 
8-11

Figure 8-3. Records Important to Decommissioning. All possession for manufacturing 

and distribution licensees must maintain records important to decommissioning, 

regardless of whether they need financial assurance for decommissioning.

In accordance with 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g), licensees must 

transfer records important to decommissioning to the new licensee before licensed activities are 

transferred or assigned, in accordance with 10 CFR 30.34(b), 40.46(b) and 70.36(b). 

Furthermore, pursuant to 10 CFR 30.51(f), 10 CFR 40.61(f), and 10 CFR 70.51(a), prior to 

license termination, each licensee must forward the records required by 10 CFR 30.35(g), 

10 CFR 40.36(f) and 10 CFR 70.25(g), respectively, to the appropriate NRC regional office.

Response from Applicants: 

• State the following: “Pursuant to 10 CFR 30.35(g), 10 CFR 40.36(f), and

10 CFR 70.25(g) and 10 CFR 70.51(b)(3), as appropriate, we will maintain records 

important to decommissioning and will transfer these records to an NRC or Agreement 

State licensee before licensed activities are transferred or assigned, in accordance with

10 CFR 30.34(b), 10 CFR 40.46, and 10 CFR 70.36, as appropriate. Furthermore, 

pursuant to 10 CFR 30.51(f), 10 CFR 40.61(f), and 10 CFR 70.51(a), as appropriate,

prior to license termination, we will forward the records required by 10 CFR 30.35(g), 

10 CFR 40.36(f), and 10 CFR 70.25(g), as appropriate, to the appropriate NRC 

regional office.”
8-12

AND

• If financial assurance is required, submit the required documents, as described in 

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

Assurance, Recordkeeping, and Timeliness.”

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

copies of NUREG–1757.

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

Regulations: 10 CFR 30.4; 10 CFR 30.33(a)(1); 10 CFR 30.41; 10 CFR 32.2; 10 CFR 32.11; 

10 CFR 32.14; 10 CFR 32.18; 10 CFR 32.21; 10 CFR 32.22; 10 CFR 32.26; 10 CFR 32.51; 

10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71; 10 CFR 32.72; 10 CFR 32.74; 

10 CFR 32.210; 10 CFR 40.4; 10 CFR 40.32; 10 CFR 51.20; 10 CFR 51.21; 10 CFR 51.22; 

10 CFR 70.4; 10 CFR 70.39; 10 CFR 70.42; 10 CFR 110.2; 10 CFR 110.20; 10 CFR 110.42; 

10 CFR 110.43; 10 CFR 110.50.

Criteria: Requested radionuclides must be possessed and used for purposes authorized by the 

Atomic Energy Act of 1954, as amended. The applicant must specify the purpose of use for 

each sealed and unsealed radionuclide requested. Sealed sources and devices containing 

licensed material must be possessed and used only for the purpose for which they are designed 

and according to manufacturer’s and distributor’s instructions and recommendations for 

possession and use, as specified in the SSD registration certificate, unless otherwise authorized 

in the license.

In order to have a license for distribution of sources and devices containing radioactive 

materials, the applicant normally must first apply for and receive a sealed source and device 

registration, in accordance with the procedures in NUREG–1556, Volume 3, “Consolidated 

Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation 

and Registration.”

Note: If distributing sealed sources and devices to medical use licenses, also see Appendix R

of this NUREG, “Medical Distribution.”

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

used. The description should be detailed enough to allow NRC to determine the potential for 

exposure to radiation and radioactive materials to those working with radioactive materials and

to members of the public.

Applicants should pay particular attention to the applicable regulations listed above when 

applying for a license to manufacture and distribute licensed material. However, this list is not 

exhaustive, nor does it relieve the applicant from complying with applicable Federal, State, and 

local requirements. 

Applicants should clearly specify if the licensed material will be used in animal studies or tracer 

studies as part of manufacturing. Use of licensed material in animals may be in quality control 

or research studies. Applicants should also state whether the studies will be limited to small 

animals (e.g., rats, mice) or may also include larger animals (e.g., pigs, dogs, horses).

Applicants including animal studies, tracers, or research and development can include the 
8-13

requested licensed materials in this application and should refer to NUREG–1556, Vol. 7, 

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

Academic, Research and Development, and Other Licenses of Limited Scope Including Electron 

Capture Devices and X-Ray Fluorescence Analyzers.” Applicants intending to possess and use 

licensed materials for medical research involving humans must be authorized to do so pursuant 

to a license issued under 10 CFR Part 35 and should refer to NUREG–1556, Vol. 9, 

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

Use Licenses.” Applicants intending to become a broad-scope licensee should refer to 

NUREG–1556, Vol. 11, “Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Licenses of Broad Scope,” for instructions.

Licensees who possess and use licensed materials to support the process of manufacturing or 

distribution must have the appropriate possession and uses described in their licenses. An 

example may be that a manufacturer of depleted uranium counterweights or shields possesses 

and uses a cesium-137 level gauge to detect blockage in the raw material hopper feed line. 

The manufacturer would need authorization not only to possess, use, and distribute the uranium 

for the counterweights and the shields, but also a line authorization to possess and use the level 

gauging device. If the licensee wishes to calibrate its own radiation survey meters and perform 

leakage and contamination tests, then they should submit separate line authorizations for the 

sources and devices that they will need to perform these tasks. The licensee should have 

procedures for these sources, devices, and uses.

Applicants may use the format given in Table 8-1 below to provide the requested information.

Table 8-1. Sample Format for Providing Information About Requested Radionuclides

Radionuclide

Chemical/Physical 

Form

Maximum 

Possession Limit Proposed Use

Manufacturing—Internal Uses

Any byproduct 

material with atomic 

numbers 1 through 83

Any Not to exceed 

370 GBq [10 Ci] per 

radionuclide and 

3,700 GBq [100 Ci]

total

Research and 

development as 

defined in 

10 CFR 30.4

Hydrogen-3 Unbound/volatile 3.7 GBq [100 mCi] Labeling of 

compounds

Hydrogen-3 Bound/non-volatile 3.7 GBq [100 mCi] In vitro studies; studies 

in small lab animals

Iodine-125 Unbound/volatile 1.11 GBq [30 mCi] Protein iodination

Iodine-125 Bound/non-volatile 1.85 GBq [50 mCi] In vitro studies; studies 

in small lab animals; 

calibration of 

instruments

Cesium-137 Sealed source, Mfg. 

name/model number

0.74 GBq [20 mCi] Calibration of 

instruments
8-14

Table 8-1. Sample Format for Providing Information About Requested Radionuclides

(Continued)

Radionuclide

Chemical/Physical 

Form

Maximum 

Possession Limit Proposed Use

Manufacturing and Distribution

Hydrogen-3 Unbound/volatile 3.7 GBq [100 mCi] Labeling of 

compounds

Iodine-125 Unbound/volatile 1.11 GBq [30 mCi] Protein iodination

Any byproduct 

material with atomic 

numbers 1 through 83

Any Not to exceed 

370 GBq [10 Ci] per 

radionuclide and 

3,700 GBq [100 Ci]

total

For possession, use, 

and processing for 

manufacturing of 

radiochemicals, 

radiopharmaceuticals, 

and sealed sources

Any byproduct 

material with atomic 

numbers 84 

through 94

Any Not to exceed 

1.85 GBq [50 mCi] per 

radionuclide and 

2 curies total

For storage prior to 

distribution of 

manufactured 

radiochemicals, 

radiopharmaceuticals, 

and sealed sources

Hydrogen-3

Carbon-14

Phosphorus-32

Phosphorus-33

Sulfur-35

Any

Any

Any

Any

Any

3700 TBq 

[100,000 Ci]18.5 TBq 

[500 Ci]

3.7 TBq [100 Ci]

0.74 TBq [20 Ci]

14.8 TBq [400 Ci]

For storage prior to 

distribution of 

manufactured 

radiochemicals, 

radiopharmaceuticals, 

and sealed sources

Hydrogen-3

Carbon-14

Phosphorus-32

Phosphorus-33

Sulfur-35

Any

Any

Any

Any

Any

3700 TBq 

[100,000 Ci]18.5 TBq 

[500 Ci]

3.7 TBq [100 Ci]

0.74 TBq [20 Ci]

14.8 TBq [400 Ci]

For packaging and 

distribution of 

manufactured 

radiochemicals, 

radiopharmaceuticals, 

and sealed sources to 

persons authorized to 

receive the licensed 

material pursuant to 

the terms and 

conditions of specific 

licenses

Molybdenum99/Technetium-99mAny 18.5 TBq [500 Ci] For possession, use, 

and processing for

manufacturing of 

radiochemicals and 

radiopharmaceuticals
8-15

Table 8-1. Sample Format for Providing Information About Requested Radionuclides

(Continued)

Radionuclide

Chemical/Physical 

Form

Maximum 

Possession Limit Proposed Use

Distribution

Xenon-133 Prepackaged Units 1.85 TBq [50 Ci] For possession 

incident to commercial 

redistribution of 

unopened containers 

to authorized 

recipients

Hydrogen-3

Carbon-14

Phosphorus-32

Phosphorus-33

Sulfur-35

Any

Any

Any

Any

Any

3700 TBq [100,000 Ci]

18.5 TBq [500 Ci]

3.7 TBq [100 Ci]

0.74 TBq [20 Ci]

14.8 TBq [400 Ci]

Distribution of 

manufactured 

radiochemicals, 

radiopharmaceuticals, 

and sealed sources

Applicants requesting a license for distribution only may need to refer to the information in 

Appendix C of this NUREG, which describes the different types of distribution licenses 

(i.e., General “G” Distribution License, Medical “MD” Distribution License, and Exempt “E” 

Distribution License), in order to determine whether this guidance document should be used for 

their application. Applicants for medical distribution licenses must refer to 10 CFR 32.72 and 

32.74, in addition to the guidance specified in Appendices C and R of this NUREG. Some 

“manufacturers” that are importers of materials and devices from abroad may not require the 

same extent of information submission and review as a facility that produces an item. However, 

they are required to have a manufacturer or distributor license as the initial importer and 

distributor in the U.S. The device distributor may be the sponsor of the “Sealed Source and 

Device Registry” certificate. The general distribution-only license (“G”) and the exempt 

distribution-only license (“E”) application requirements are not covered in this document. 

Applicants for these licenses are referred to NUREG–1556, Vol. 16, “Consolidated Guidance 

About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution 

to General Licensees,” and NUREG–1556, Vol. 8, “Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About Exempt Distribution Licenses.”
8-16

Figure 8-4. Example of a Product Produced Under Possession for Manufacturing and 

Distribution Authorization

Response from Applicant:

• List the specific use or purpose of each radionuclide that will be possessed and used.

1

• Provide the manufacturer name and model number for each device, manufactured 

article, or material that becomes the product, by manufacturer and model number.

• Provide the manufacturer and model number of each sealed source proposed for 

possession and use or incorporation into a manufactured article.

• Submit information requesting authorization to possess and use any other licensed 

materials in support of the manufacturing and distribution license.

Note: Applicants intending to manufacture sealed sources or devices for medical use should 

refer to Appendix R of this NUREG, Item 10.2, for sealed source and device licensing criteria for 

evaluation of design and construction.

 

1See Table 8-1. 
8-17

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

Their Training and Experience

Regulations: 10 CFR 30.33(a)(3); 10 CFR 40.32(b); 10 CFR 70.22(a)(6); 10 CFR 70.23(a)(2)

Criteria: Executive management, the Radiation Safety Officer (RSO) (and his or her staff, as 

necessary), and authorized users work as a team to implement the Radiation Protection 

Program. Each individual and position plays a critical role within his or her area of 

responsibility. The roles and responsibilities of executive management, the RSO, the Radiation 

Safety Office staff, authorized users, and others in restricted areas are discussed in the sections 

that follow. Refer to the subsequent sections specific to the RSO and Authorized Users 

described above. 

Note: NUREG–1516, “Management of Radioactive Material Safety Programs at Medical 

Facilities,” describes the role of executive management and the RSO at medical facilities and

contains information that may be useful to licensees authorized for possession for 

manufacturing and distribution.

Discussion: The applicant or licensee must be qualified by training and experience to possess 

and use the material for the purpose requested in a manner that will protect health and minimize 

danger to life or property before an application for a license is approved.

Each program in which radioactive materials are possessed and used under an NRC license 

must have someone responsible for radiation safety and compliance with the NRC’s regulations. 

In a small program, the responsibility may be combined with or assigned to (or assumed by) the 

same individual using radioactive materials; therefore, an authorized user may serve as an 

RSO. In a medium-sized program, the responsibility may be assigned to an individual on a 

part-time basis with that person’s primary responsibility being in another area of work. For large 

programs, the many facets of occupational and environmental radiation safety will often require

that responsibility for the Radiation Safety Program be assigned to a qualified individual on a 

full-time basis. His or her training and experience must be commensurate with his or her duties 

and responsibilities. Supporting staff should be provided, as appropriate, for the size and scope 

of the program. A large program may have some or all of the following characteristics:

• in-house calibration of radiation survey, monitoring, and measurement instruments

• possession and use of multiple chemical and physical forms of multiple radionuclides for 

various purposes

• program flexibility with regard to the possession and use of radionuclides, their chemical 

and physical form, and the uses to be made of such radionuclides

• accurate detection, identification, and measurement of radioactivity in various types of 

effluents (gas, liquid, solid) containing varying amounts of different radionuclides and for 

evaluation of these effluents against NRC regulatory requirements and limitations

• radioactive effluent treatment by filtration, absorption, adsorption, holdup, etc.

• selection, evaluation, design, fabrication, maintenance, and use of radioactive effluent 

treatment systems
8-18

• selection, evaluation, and maintenance of radiation measurement and 

analysis equipment

• potential for the contamination of facilities, equipment, and personnel accompanied by

the need to control such contamination (including airborne contamination), 

decontaminate personnel and equipment, and evaluate possible internal dose 

(including determination of the need for bioassays and interpretation of bioassay results)

The licensee’s senior management maintains the ultimate responsibility for the safety of 

licensed activities. NRC holds the licensee responsible for the Radiation Protection Program; 

therefore, it is essential that strong management controls and oversight exist to ensure that 

licensed activities are conducted safely. Management responsibility and liability are sometimes 

underemphasized or not addressed in applications and are often poorly understood by licensee 

employees and managers. As discussed later in this guide, senior management should 

delegate to the RSO sufficient authority, organizational freedom, and management prerogative 

to communicate with and direct personnel regarding NRC regulations and license provisions 

and to terminate unsafe activities involving byproduct, source, and special nuclear material.

Other responsibilities may be delegated to other individuals with adequate training and 

experience. Such delegations should be clearly communicated to all parties. 

If a license of broad-scope is being sought (under 10 CFR Part 33, “Specific domestic licenses 

of broad scope for byproduct material”), also refer to NUREG–1556, Vol. 11, “Consolidated 

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

Broad Scope.”

Response from Applicant: Refer to the subsequent sections specific to the individuals 

described above. Applicants should submit an organizational chart describing the management 

structure, reporting paths, and the flow of authority between executive management and 

the RSO.

8.7.1 Radiation Safety Officer

Regulations: 10 CFR 30.33(a)(3); 10 CFR Part 37; 10 CFR 40.32(b); 10 CFR 70.23(a)(2)

Criteria: RSOs must have adequate training and specific experience with the types and 

quantities of licensed material to be authorized on the license.

Discussion: The person responsible for implementing the radiation protection program 

including overseeing and ensuring that the licensee’s radioactive material is used and stored 

safety and securely is the RSO. For licensees possessing an aggregated Category 1 or 

Category 2 quantity of radioactive material, the RSO should participate in the development 

and implementation of a security program for radioactive material in accordance with 

10 CFR Part 37. A “Category 1 quantity of radioactive material” and a “Category 2 quantity of 

radioactive material” are defined terms in 10 CFR 37.5, and the radionuclides referenced in 

these 10 CFR 37.5 definitions are listed in Appendix A to 10 CFR Part 37. The RSO must have 

adequate training to understand the hazards associated with radioactive material and be familiar 

with all applicable regulatory requirements. The RSO should have independent authority to stop 

operations that he or she considers unsafe. He or she should have sufficient time and 

commitment from management to fulfill certain duties and responsibilities to ensure that 

radioactive materials are possessed and used in a safe manner, approved radiation safety 

procedures are being implemented, and the required records of licensed activities are 
8-19

maintained. Typical RSO duties are illustrated in Figure 8-5 and described in Appendix D of this 

NUREG. The NRC requires the name of the RSO to be listed on the license to ensure that 

licensee management always has a responsible, qualified person and that the named individual 

knows of his or her designation as RSO. Appendix D of this NUREG also provides a model 

Delegation of Authority, which should be used to further emphasize the agreement on duties 

and responsibilities of the RSO by management and the designated RSO.

Figure 8-5. Typical Duties and Responsibilities of RSOs

The RSO should have at a minimum, (i) a college degree at the bachelor level or equivalent 

training and experience in the physical or biological sciences or in engineering; and (ii) training 

and experience commensurate with the scope of proposed activities. 

Training should include the following subjects:

• radiation protection principles

• characteristics of ionizing radiation

• units of radiation dose and quantities

• radiation detection and measurement instrumentation

• biological hazards of exposure to radiation (appropriate to types and forms of licensed 

material to be possessed and used)

• NRC regulatory requirements and standards

• hands-on use of radioactive materials commensurate with the uses proposed by 

the applicant
8-20

Experience should include the following areas:

• planning and conducting evaluations, surveys, and measurements similar to those 

required by the licensee’s Radiation Safety Program

• using licensed materials that are similar in types, forms, and quantities to those 

proposed for use under the license

• securing and controlling licensed materials

• monitoring inventory of materials possessed under the license; maintaining records of 

receipts, transfers, and disposal of licensed materials

• storing, handling, disposing of and documenting radioactive waste materials

• planning, conducting, and documenting audits and other evaluations of the radiation 

safety program

• evaluating and documenting radiation exposures

• maintaining required records of the radiation safety program and providing

required reports

• other applicable duties and responsibilities as described in Appendix D of this NUREG

The amount of training and experience will depend on the type, form, quantity, and proposed 

use of the licensed material requested. For example, in addition to a college degree, RSOs at a 

manufacturing company where workers handle curie quantities of radioactive material should be 

specialists in the field of radiation protection and may need at least 40 hours of radiation safety 

training specific to their job duties, as well as 1 year of experience with similar types, forms, 

quantities, and uses of radioactive material before the individual is qualified to be RSO. The 

proposed RSO’s training and experience should be sufficient to identify and control the 

anticipated radiation hazards. The RSO designee should have obtained the above training in 

formal course(s) designed for RSOs, presented by an academic institution, commercial radiation 

safety consulting company, or a professional organization of radiation protection experts.

Another example is for distributors who import sealed material that are distributed as exempt 

quantities; for these licensees, the RSOs may only need basic radiation safety and 

transportation training and no prior experience working with radioactive material.

Response from Applicant: 

Provide the following:

• name of the proposed RSO

• information demonstrating that the proposed RSO is qualified by training and experience

should include, as a minimum:

— formal training and education in radiation safety (topics covered, duration of 

training, when training was received, identity/location of training provider)

(Note: a course outline may be provided)
8-21

— experience using licensed materials (types, forms, quantities handled, activities 

performed, duration of experience)

— experience performing the duties of a RSO (activities, duration of experience, 

scope of program)

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

relative to the licensed material and uses requested in the application. Do not include 

personally identifiable information (PII) (e.g., home address, home telephone number, social 

security number, date of birth, and radiation dose information). For further information 

concerning PII, see Chapter 6, “Identifying and Protecting Sensitive Information.” Applicants 

should not submit extraneous information, such as unrelated lists of publications, research 

grants, committee and society memberships, and personal private information. Submittal of 

unrelated material may slow down the review process. 

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

designation of the RSO listed on the license. Applicants should review the regulations for 

specific program areas, such as medical uses, that have specific requirements regarding 

changes in the RSO.

8.7.2 Authorized Users

Regulations: 10 CFR 20.1101(b); 10 CFR 30.33(a)(3); 10 CFR 40.32(b); 10 CFR 70.23(a)(2); 

10 CFR 71.5; 10 CFR 110.26; 10 CFR 110.27; 10 CFR 110.28; 10 CFR 110.29;

10 CFR 110.30; 10 CFR 110.42; 10 CFR 110.43; 10 CFR 110.44; 49 CFR Parts 170 through 

180 (appropriate to the mode of transport).

Criteria: Authorized Users (AUs) must have adequate training and experience with the types 

and quantities of licensed material that they propose to possess and use.

Discussion: Applicants must name at least one individual who is qualified to use the requested 

licensed materials. An AU is a person whose training and experience have been reviewed and 

approved by NRC, who is normally named on the license, and who uses or directly supervises 

the use of licensed material. The AU’s primary responsibility is to ensure that radioactive 

materials are used safely and according to regulatory requirements. The AU is also responsible 

for ensuring that procedures and engineering controls are used to keep occupational doses and 

doses to members of the public ALARA.

AUs must have adequate training and experience to provide reasonable assurance that they will 

use licensed material safely. Training for AUs should include maintaining the security of, and 

controlling access to, licensed material, and responding appropriately to events or accidents 

involving licensed material to prevent the spread of contamination.

The NRC believes that the AU should have (i) a college degree at the bachelor level or 

equivalent training and experience in physical, chemical, or biological sciences or in engineering
8-22

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

should include the following subjects:

• radiation protection principles

• characteristics of ionizing radiation

• units of radiation dose and quantities

• radiation detection instrumentation

• biological hazards of exposure to radiation (appropriate to the types and forms of 

byproduct material that the licensee will use)

• hands-on use of radioactive materials

The amount of training and experience needed will depend upon the type, form, quantity, and 

proposed use of the licensed material requested, but it should cover the subjects stated. 

For instance, in addition to a college degree, AUs at a manufacturing company where workers 

handle curie quantities of radioactive material should have 40 hours of radiation safety training 

and a minimum of 6 months of experience with similar types, forms, quantities, and uses of 

radioactive material before the individual is qualified to be an authorized user. On the other 

hand, AUs at “manufacturers” who are importers of timepieces containing tritium that are 

received in the U.S. as completed products that will be distributed as exempt quantities may 

only require a few hours of radiation safety training and no prior experience with timepieces 

containing tritium to be qualified as an AU. In general, AUs must demonstrate training and 

experience with the type and quantity of material that they propose to use. For example, 

someone with training and experience only with sealed radioactive sources may not be qualified 

to use or supervise the use of unsealed licensed material. In addition, someone with 

experience using only trace quantities may not understand the risks of working with much larger 

(e.g., 10 or 100 times larger) quantities of the same substance. Applicants should pay particular 

attention to the type of radiation involved. For example, someone experienced with gamma 

emitters may not have appropriate experience for high-energy beta emitters.

An AU is considered to be supervising the use of radioactive materials when he or she directs 

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

tasks to supervised users (e.g., conducting surveys, keeping records), he or she is responsible 

for the safe use of radioactive material to ensure that areas are not contaminated.

Response from Applicant: Provide the following:

• name of each proposed AU with the types and quantities of licensed material to be 

possessed or possessed and used

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

to possess and use the requested licensed materials, including, as a minimum:

— formal training and education in radiation safety (topics covered, duration of 

training, when training was received, identity/location of training provider)

(Note: a course outline may be provided) 
8-23

— experience using licensed materials (types, forms, quantities handled, activities 

performed, duration of experience)

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

to the licensed material requested in the application. Do not include PII (e.g., home address, 

home telephone number, social security number, date of birth, and radiation dose information). 

For further information concerning PII, see Chapter 6, “Identifying and Protecting Sensitive 

Information.” Applicants should not submit extraneous information, such as unrelated lists of 

publications, research grants, committee and society memberships, etc. Submittal of unrelated 

material may slow the review process.

Note: Applicants for broad scope programs should refer to NUREG–1556, Vol. 11, 

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

of Broad Scope.” Broad-scope programs may be permitted to name authorized users without 

amending the license.

8.8 Item 8: Training for Individuals Working in or Frequenting 

Restricted Areas 

Regulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 20.1801; 10 CFR 20.1802; 

10 CFR 30.9; 10 CFR 30.33(a)(3); 10 CFR 30.34(e); 10 CFR 37.43; 10 CFR 40.32(b); 

10 CFR 40.41(e); 10 CFR 70.23(a)(2); 10 CFR 70.32(b)

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

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

likely to receive in a year an occupational dose of radiation greater than 1 mSv [100 mrem], 

whether from all external sources, all internal sources, or any combination, must receive 

instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12. 

Any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive 

material (as defined in 10 CFR 37.5) must implement a training program for those individuals 

implementing the security program.

Discussion: Before beginning work with or in the vicinity of licensed material, all individuals

who are likely to receive an occupational dose in excess of 1 millisievert (mSv) [100 millirem] in 

a year must receive radiation safety training commensurate with their assigned duties and 

specific to the licensee’s Radiation Safety Program. Each individual should also receive 

periodic (for example, annual) refresher training. Training should also be performed whenever 

there is a significant change in hazards, duties, procedures, regulations, or terms of the license.

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

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

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

may require special procedures, such as working in hot cells. Ancillary personnel (e.g., clerical, 

housekeeping, security) whose duties may require them to work in the vicinity of radioactive 

material (whether escorted or not) need to be informed about radiation hazards and the 

appropriate precautions. The licensee should assess each individual’s involvement with 

licensed material and cover each applicable subject appropriately.

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

should emphasize practical subjects important to the safe possession and use of licensed 
8-24

material. If training is not conducted by an instructor, a method should be adopted whereby a 

trainee can ask questions and discuss topics relating to occupational radiation exposure. The 

guidance in Appendix E of this NUREG, “Radiation Safety Training,” may be used to develop a 

training program. The program should consider all topics pertinent for each group of workers,

as well as the method and frequency of training. The licensee should determine whether the 

training succeeded in conveying the desired information and adjust the training program as 

necessary. This assessment may be performed by a test or observation of the individual in the 

performance of assigned duties. Remedial training for missed test questions or other areas of 

apparent weakness should be conducted or additional formal training planned to cover 

deficient areas.

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

the qualifications for RSO or authorized user on the license and is familiar with the 

licensee’s program).

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must implement a training program in accordance 

with 10 CFR 37.43, “General security program requirements,” and specifically, must comply with 

10 CFR 37.43(c), “Training,” to ensure that those individuals who may have a responsibility to 

implement portions of the security program possess and maintain the knowledge, skills, and 

abilities to carry out their assigned duties and responsibilities effectively. Additionally, in 

accordance with 10 CFR 37.43(c)(3), refresher training must be provided at a frequency not to 

exceed 12 months and when significant changes have been made to the security program. For 

additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

Response from Applicant: Submit a description of the radiation safety training program, 

including topics covered, groups of workers, assessment of training, qualifications of instructors, 

and the method and frequency of training.

8.9 Item 9: Facilities and Equipment 

Regulations: 10 CFR 20.1101(b); 10 CFR 20.1406; 10 CFR 30.33(a)(2); 10 CFR 30.35(g); 

10 CFR Part 37; 10 CFR 37.5; 10 CFR 37.49; 10 CFR 37.53; 10 CFR 40.27(b); 

10 CFR 40.28(b); 10 CFR 40.31(h); 10 CFR 40.32(c); 10 CFR 40.34(a); 10 CFR 70.23(a)(3); 

10 CFR 70.39(a).

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

life or property. Facilities and equipment must also provide enhanced physical protection of 

aggregated Category 1 and Category 2 quantities of radioactive material, as defined in 

10 CFR 37.5. They must minimize the possibility of contamination and keep exposures to 

workers and the public ALARA. Applicants must describe how facility design and procedures 

for operation will minimize, to the extent practicable, contamination of the facility and the 

environment; facilitate eventual decommissioning; and minimize, to the extent practicable, the 

generation of radioactive waste.
8-25

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

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

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

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

be used.

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

review is completed and the license is issued, in case changes are required as a result of the 

application review. In all cases, the applicant may not possess or use licensed material until 

after the facilities are completed in accordance with the license, equipment is procured, and a 

prelicensing assessment has been performed by the NRC.

Applicants are reminded that records important to decommissioning as described in 

10 CFR 30.35(g), 40.36(f), and 70.25(g) must include the following:

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

• as-built drawings and modifications of locations of possible inaccessible contamination 

such as buried pipes that may be subject to contamination

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

or site

These records are required to be maintained in an identifiable location. Facilities will be 

considered acceptable for unrestricted use if the NRC release criteria are met as required by 

10 CFR Part 20, Subpart E requirements. Therefore, careful facility design is important to 

prevent contamination, or to facilitate decontamination, reducing the costs needed for 

decommissioning. For further information, see Section 8.5.2, Financial Assurance and 

Recordkeeping for Decommissioning.

For additional guidance regarding facilities and equipment, refer to Appendix F of this NUREG, 

“Facilities and Equipment.”

When designing facilities and developing procedures for their safe use, applicants should think 

ahead and consider how to minimize radioactive contamination during operation, 

decontamination and decommissioning efforts, and radioactive waste generation. When 

submitting new applications, applicants should consider the following:

• implementation of and adherence to good health physics practices in operations

• minimization of areas, to the extent practicable, where licensed materials are used 

and stored

• maximization of the frequency of surveys, within reason, to minimize spread of 

contamination in the event of a spill

• choice of isotope to be used, whenever practical, in consideration of half-life and 

chemical composition

• appropriate filtration of effluent streams
8-26

• use of nonporous materials for such areas as counter tops and flooring

• ventilation ductwork with minimal lengths and minimal abrupt changes in direction

• use of appropriate plumbing materials with minimal pipe lengths and traps

• minimization of the number of disposal sites (sinks) where liquid waste is disposed

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things,

• implement the physical protection requirements in 10 CFR Part 37 for material in use 

and storage, at both permanent and temporary jobsites; and

• in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices, and immediately detect any unauthorized removal of Category 1 

quantities of radioactive material from the security zone. (Monitoring and detection 

systems may include, among other methods, monitored video surveillance systems and 

electronic devices for intrusion detection alarms.)

• for mobile devices containing Category 1 or Category 2 quantities of radioactive 

material, have two independent physical controls to secure the material from 

unauthorized removal when the device is not under direct control and constant 

surveillance in accordance with 10 CFR 37.53. “Mobile device” is defined in 

10 CFR 37.5.

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for the protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

Response from Applicant: 

• Describe the facilities and equipment to be made available at each location where

radioactive material will be possessed or possessed and used (see Appendix F of this 

NUREG for topics to consider). This information should be from the point of view of 

performance criteria. For example, state the purpose of any filtration equipment and the 

associated acceptance criteria to accomplish this purpose (such as the ventilation flow 

rate trying to be maintained).

• Include a description of the areas assigned for the receipt, shipping, storage, 

preparation, security, and measurement of radioactive materials.
8-27

• Submit a diagram showing the locations of shielding, the proximity of radiation sources 

to unrestricted areas, areas containing flammable or hazardous materials, and other 

items related to radiation safety (see Figure 8-6). 

— When applicable to facilities where radioactive materials may become 

airborne, the diagrams should contain schematic descriptions of the 

ventilation systems, with pertinent airflow rates, pressures, filtration 

equipment, and monitoring systems. 

• Diagrams should be drawn to a specified scale or dimensions should be indicated. 

Sketches or drawing should also include a compass directional arrow to indicate “North”.

— For facilities where it is anticipated that more than one laboratory or room may be 

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

• If radioactive materials will be used with animals, include a description of the 

animal-handling housing facilities. NUREG–1556, Vol. 7 may also be used as guidance.

• Specialized facilities such as waste storage rooms or hot labs, and locations of 

specialized facilities or equipment such as waste compactors, hot cells, and shielded 

storage for high activity sources, should be included on the diagram.

Note: Diagrams of facilities should be marked: “Security-Related Information—Withhold under 

10 CFR 2.390.”

Figure 8-6. Diagram Showing Information Related to Radiation Safety. This diagram is 

an example only and does not contain actual security-related information.

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

“Operational Radiation Safety Program.”
8-28

8.10 Item 10: Radiation Safety Program

8.10.1 Audit and Review of Program 

Regulations: 10 CFR 20.1101; 10 CFR 20.2102, 20.2110, 10 CFR 21.21(a); 10 CFR 37.33;

10 CFR 37.55

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

programs at least annually to ensure the program

• is commensurate with the scope and extent of licensed activities

• is compliant with NRC and DOT regulations (as applicable), and the terms and 

conditions of the license

• maintains occupational doses and doses to members of the public ALARA 

(10 CFR 20.1101)

• is documented, and appropriate records are maintained for the duration required by 

the regulations

Records of audits and other reviews of program content must be maintained for 3 years after 

the record is made, in accordance with 10 CFR 20.2102.

Licensees that are subject to the requirements in 10 CFR Part 37 must annually review their 

access authorization program and security program.

Discussion: Appendix G of this NUREG contains a suggested audit program that is specific to 

possession licenses for manufacturing and distribution and is acceptable to NRC. Because all 

areas indicated in Appendix G may not be applicable to every licensee and all items may not 

need to be addressed during each audit, licensees may wish to develop a program-specific 

audit checklist.

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

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

the audit program, licenses should consider including unannounced audits of users to observe 

whether radiation safety procedures are being followed.

It is essential that once problems are identified, comprehensive corrective actions are taken in a 

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

and Implementation of Corrective Action,” dated May 1, 1996, provides guidance on this 

subject. The NRC routinely reviews licensee’s records to verify whether appropriate corrective 

actions were implemented in a timely manner to prevent recurrence. It is in the best interest of 

the licensee to identify potential violations of regulatory requirements and take necessary steps 

to correct them. The NRC can opt to exercise discretion and may elect not to cite the licensee 

for these violations if prompt and effective corrective actions are implemented. The NRC’s 

Enforcement Policy may be found online at https://www.nrc.gov/aboutnrc/regulatory/enforcement/enforce-pol.html. The Enforcement Manual may be found online at 

https://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. For examples of the 

NRC’s use of discretion in issuing a notice of violation, refer to the most recent version of NRC’s 

enforcement documents at https://www.nrc.gov/reading-rm/doc-collections/enforcement/.
8-29

With regard to audit records, 10 CFR 20.2102 requires, in part, that licensees maintain records 

of “audits and other reviews of program content and implementation” for 3 years after the record 

is made. The NRC has found audit records that contain the following information to be 

acceptable: date of audit, name of person(s) who conducted audit, persons contacted by the 

auditor(s), areas audited, audit findings, corrective actions, and followup.

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things,

• in accordance with 10 CFR 37.33, review its access authorization programs at least 

annually to confirm compliance with the requirements of Subpart B of 10 CFR Part 37 

and ensure that comprehensive actions are taken to correct any noncompliance that 

is identified; and

• in accordance with 10 CFR 37.55, review its security program at least annually to 

confirm compliance with the requirements of Subpart C of 10 CFR Part 37 and ensure 

that comprehensive actions are taken to correct any noncompliance that is identified.

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may

be subject to review and inspection.

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

program to the NRC for review as part of a license application. However, the audit program

may be reviewed during NRC inspections.

References: 

• Inspection Procedure 87126, “Industrial/Academic/Research Programs,”

September 2005

• Inspection Procedure 87125, “Materials Processor/Manufacturer Programs,” 

September 2005

• Information Notice 96-28, “Suggested Guidance Relating to Development and 

Implementation of Corrective Action,” dated May 1, 1996

8.10.2 Radiation Monitoring Instruments

Regulations: 10 CFR 20.1501; 10 CFR 20.2103(a); 10 CFR 30.33(a)(2); 10 CFR 40.32(c); 

10 CFR 70.23(a)(3)

Criteria: Licensees must possess, or have access to, radiation monitoring instruments that are 

necessary to protect health and minimize danger to life or property. Instruments used for 

quantitative radiation measurements must be calibrated periodically for the radiation measured.
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Discussion: Licensees must possess, or have access to, calibrated radiation detection and 

measurement instruments or licensed services to perform, as necessary, the following:

• package surveys

• measure personnel and facility contamination

• test for sealed source leaks

• take and measure air samples

• take bioassay measurements

• take effluent release measurements

• perform dose rate surveys

For the purposes of this document, radiation monitoring instruments are defined as any device 

used to measure the radiological conditions at a licensed facility. Some of the instruments that 

may be used to perform the above functions include:

• portable or stationary count rate meters

• portable or stationary dose rate or exposure rate meters

• single or multichannel analyzers

• liquid scintillation counters

• gamma counters

• proportional counters

• solid state detectors

• neutron detectors

Other equipment and instrumentation associated with the radiation hazard assessment also 

must be calibrated periodically, in accordance with 10 CFR 20.1501(c). This includes 

equipment used to collect radiological samples to perform assessments of airborne hazards and 

other radiological hazards that cannot be directly assessed, such as

• rotameters

• anemometers

• other devices that measure air pump flow rates, volumes, and time

• liquid volume collection and measurement devices

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

the type of measurement to be taken (e.g., count rate, dose rate). Applications should include 

descriptions of the instrumentation available for use and the instrumentation that applicants 

intend to purchase prior to starting licensed activities. The description should include the type of 

instrument and probe, and the instrument’s intended purpose.

NRC regulation (10 CFR 20.1501) requires that radiation survey instruments used for 

quantitative measurements be calibrated periodically. Calibrations requiring the use of 

radioactive sources should be performed by the instrument manufacturer or persons specifically 

authorized by the NRC or an Agreement State, unless the applicant specifically requests 

this authorization. Radiation survey instruments should be calibrated at least annually 

(every 12 months), unless another frequency is specified by regulation or license condition.

Applicants seeking authorization to perform radiation survey instrument calibrations will need to 

submit procedures for review. The licensee may wish to review available industry standards for 

calibration of instruments, such as American National Standards Institute (ANSI) N323A-1997, 

“Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments.” 

Appendix H of this NUREG provides radiation monitoring instrument specifications and a model 
8-31

radiation survey instrument calibration program. Applicants should be aware that calibrations 

often require possession and use of a calibration source or device. Regardless of whether an 

applicant is authorized to calibrate radiation survey meters or contracts with an authorized firm 

to perform calibrations, the licensee must retain records of the calibration of instruments and 

equipment used for quantitative radiation measurements for 3 years after the record is made, in 

accordance with 10 CFR 20.2103(a).

Some instruments may only need to be checked periodically for operability and response to 

radiation rather than receive full calibration. For example, G-M detection instruments used to 

identify contamination in laboratories may only need to be checked for ability to detect low-level 

contamination. However, such instruments cannot be used for quantitative measurement of 

surface contamination or radiation levels without a calibration with appropriate radioactive 

sources, as described in Appendix H of this NUREG.

Response from Applicant:

For Radiation Monitoring Instruments

Describe the instrumentation that will be used to perform required surveys.

AND

State that: “We will use instruments that meet the radiation monitoring instrument specifications 

published in Appendix H in NUREG–1556, Volume 12, Revision 1, “Consolidated Guidance 

About Materials Licenses: Program-Specific Guidance About Possession Licenses for 

Manufacturing and Distribution.” We reserve the right to upgrade our radiation survey 

instruments as necessary.”

For Instrument Calibration

State that: “Instruments will be calibrated before first use, at least annually thereafter, and after 

any repair, by a vendor that the NRC or an Agreement State has licensed to perform 

instrument calibration.”

OR

State that: “We will implement the model radiation survey instrument calibration program 

published in Appendix H in NUREG–1556, Volume 12, Revision 1, “Consolidated Guidance 

About Materials Licenses: Program-Specific Guidance About Possession Licenses for 

Manufacturing and Distribution.””

OR

Submit equivalent procedures for instrument calibrations.

Note: Alternative responses will be reviewed using the guidance in this section.

8.10.3 Material Receipt and Accountability

Regulations: 10 CFR 20.1501(a); 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.1906; 

10 CFR 20.2001; 10 CFR 20.2108; 10 CFR 20.2201; 10 CFR 20.2207; 10 CFR 30.34(e);
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10 CFR 30.35(g); 10 CFR 30.41; 10 CFR 30.51; 10 CFR 37.49; 10 CFR 37.71; 10 CFR 37.75;

10 CFR 37.77; 10 CFR 40.36(f); 10 CFR 40.41(e); 10 CFR 40.51; 10 CFR 40.61;

10 CFR 70.25(g); 10 CFR 70.32(b); 10 CFR 70.42; 10 CFR 70.51

Criteria: Licensees must do the following:

• develop, implement, and maintain written procedures for safely opening packages

• develop, implement, and maintain procedures to ensure security and accountability of 

licensed material

• maintain records of receipt, transfer, and disposal of licensed material

• update transactions in the National Source Tracking System (NSTS), including 

performing annual inventory reconciliation, if applicable

• before transferring aggregated Category 1 or Category 2 quantities of radioactive 

material listed in Appendix A to 10 CFR Part 37, use NRC’s license verification system 

to verify that the recipient licensee is authorized to possess the radioactive material

• preplan, coordinate, and provide advance notification of shipment of Category 1 

quantities of radioactive material, and coordinate shipment of Category 2 quantities of 

radioactive material listed in Appendix A to 10 CFR Part 37

• conduct physical inventories at intervals not to exceed 6 months (or some other interval 

justified by the applicant and approved by the NRC) to account for all sealed sources in 

accordance with license condition

Discussion: To ensure that only trained, experienced, and authorized individuals use or 

supervise the use of licensed material, the RSO should know who has requested an order of 

licensed material and the types and amounts of licensed materials requested. Control 

procedures should also be established for the procurement of licensed materials that may be 

obtained outside the normal channels (e.g., through the loan or other transfer of materials 

without purchase or through surplus). A sample procedure for Ordering and Receiving 

Radioactive Material is included in Appendix I of this NUREG.

For aggregated Category 1 and Category 2 quantities of radioactive material, licensees must, 

according to 10 CFR 37.49(a)(1), continuously monitor and detect, without delay, all 

unauthorized entries into security zones. Additionally, for Category 1 quantities of radioactive 

material, 10 CFR 37.49(a)(3)(i) requires immediate detection of any attempted unauthorized 

removal of the radioactive material from the security zone. For Category 2 quantities of 

radioactive material, 10 CFR 37.49(a)(3)(ii) requires weekly verification through physical 

checks, tamper indicating devices, use, or other means to ensure that the radioactive material 

is present.

Licensed material is considered to become part of the licensee’s inventory at the time that it is 

received by the licensee, be it during normal working hours or after hours when delivered by the 

carrier, in accordance with procedures established by the licensee. If through some error, the 

licensee receives material it is unauthorized to possess or receives quantities of material that 

would result in the total inventory being in excess of license possession limits, the licensee 

should place the package in secure storage and arrange for the return of these materials in a 
8-33

timely manner. If return of the materials is not possible, the licensee should contact the NRC 

regional office and request issuance of an expedited license amendment. The materials must 

not be used until the amendment is granted.

Licensees should make arrangements to receive radioactive packages when they are delivered 

or to be notified when radioactive packages arrive at the carrier’s terminal so that the licensee 

can pick up the package expeditiously. Licensees are required to develop, implement, and 

maintain written procedures for safely opening packages, in accordance with 10 CFR 20.1906, 

“Procedures for receiving and opening packages.” Some packages may require special 

procedures that take into consideration the type, quantity, or half-life of the nuclide being 

delivered. Sample procedure for safely opening packages containing licensed materials is 

included in Appendix I of this NUREG.

In many limited-scope radiation safety programs, the RSO or his or her staff usually receives the 

incoming package directly from the carrier and performs all verification, surveying, opening, and 

documentation for inventory. The package is then delivered to the AU, or the AU retrieves the 

package from the RSO. If the package is transported over public roads by the licensee, it must 

be repackaged and transported, in accordance with DOT regulations.

If the package of licensed material is delivered to the licensed facility’s receiving department, 

individuals working in that department should be trained to do the following:

• Identify the package as radioactive by labeling and shipping papers.

• Segregate the package from other incoming items in a secured area until released by 

the RSO.

• Notify the RSO.

When notified that a package of licensed material has arrived, the RSO or his or her staff should 

retrieve the package and follow the safe-opening procedures.

NRC regulations in 10 CFR 20.1906(b) and (c) state the requirements for monitoring packages 

containing licensed material. These requirements are described in Table 8-2, below.

Table 8-2. Package Monitoring Requirements

Package Contents Survey Type Survey Time*

Damaged Licensed Material Radiation Level 

and Radioactive 

Contamination

[§20.1906(b)(3)]

As soon as practicable, 

but not later than 

3 hours after receipt 

of package

Labeled 

(White I, Yellow II, 

Yellow III)

Not Gas Nor Special Form

Greater Than Type A

Radiation Level 

[§20.1906(b)(2)]

and Radioactive 

Contamination 

[§20.1906(b)(1)]

As soon as practicable, 

but not later than 

3 hours after receipt 

of package

Labeled 

(White I, Yellow II, 

Yellow III)

Gas or Special Form

Greater Than Type A

Radiation Level 

[§20.1906(b)(2)]

As soon as practicable, 

but not later than 

3 hours after receipt 

of package
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Table 8-2. Package Monitoring Requirements

Package Contents Survey Type Survey Time*

Labeled 

(White I, Yellow II, 

Yellow III)

Not Gas Nor Special Form

Less Than or Equal to 

Type A

Radioactive 

Contamination 

[§20.1906(b)(1)]

As soon as practicable, 

but not later than 

3 hours after receipt 

of package

Labeled (White I, 

Yellow II, Yellow III)

Gas or Special Form

Less Than or Equal to 

Type A

None 

[§20.1906(b)(1)]

None

Not Labeled Licensed Material None

[§20.1906(b)]

None†

*Assumes packages are received during normal working hours. If packages are received outside of normal working 

hours, the licensee has 3 hours after the beginning of the next work day to perform the required surveys.

†Excepted Packages and limited-quantity packages received by many laboratories are required to have the 

appropriate identification number from the Hazardous Materials Table in 49 CFR 172.101 (i.e., the “UN number”) on 

the outside of the box, identifying it as containing radioactive materials. It is a good health physics practice to perform 

an incoming survey on these packages, even though transportation regulations do not require it.

The licensee is required to immediately notify the final delivery carrier and the NRC Operations 

Center by telephone at 310-816-5100, pursuant to 10 CFR 20.1906(d), when removable 

radioactive surface contamination exceeds the limits of 10 CFR 71.87(i) or external radiation 

levels exceed the limits of 10 CFR 71.47. The limits in 10 CFR 71.87(i) refer to 

49 CFR 173.443, Table 9; for packages that are not transported by exclusive use shipment 

(i.e., most packages), the relevant limits will be for “Non-fixed external radioactive contamination 

limits for packages” for beta/gamma emitters and low-toxicity alpha emitters, 4 Bq/cm2

[240 disintegrations per minute (dpm)/cm2], and for all other alpha emitters, 0.4 Bq/cm2

[24 dpm/cm2

] on the external surfaces of the package. The limits in 10 CFR 71.47 that are

applicable to packages that are not transported by exclusive-use shipment (i.e., most packages) 

are 2 mSv/h [200 mrem/h] at any point on the external surface of the package and the transport 

index does not exceed 10. 

As illustrated in Figure 8-7, licensed materials must be tracked from “receipt to disposal” in order 

to ensure accountability at all times; identify when licensed material may be lost, stolen, or 

misplaced; and to ensure that possession limits listed on the license are not exceeded.

Licensees are required under 10 CFR 20.1801 and 20.1802 to secure radioactive materials 

from unauthorized removal or access while in storage in controlled or unrestricted areas and to 

control and maintain constant surveillance over licensed material that is in a controlled or 

unrestricted area and is not in storage. Applicants for limited-scope licenses should establish 

policies and procedures for ensuring accountability of licensed materials.
8-35

Figure 8-7. Material Receipt and Accountability. Licensees must maintain records of 

receipt, transfer, and disposal of licensed material.

Inventory and Accountability of Radioactive Materials

Licensees who use or possess sealed sources are required by license condition to perform 

inventories of all sealed sources, including those that are in storage, every 6 months. Licensees 

are also required to conduct leak tests of sealed sources at 6-month intervals (or at longer 

intervals as specified in the SSD registration certificate). Since leak tests require an individual 

to locate and work with the sealed source, records of leak tests may be used as part of an 

inventory and accountability program.

With regard to unsealed licensed material, licensees may use various methods (e.g., computer 

programs, manual ledgers, log books) to account for the inventory of unsealed materials from 

the time of receipt, through the use and storage of the unsealed materials, to removal from 

inventory through transfer, disposal, or radioactive decay. The chosen methods should ensure 

that possession limits are not exceeded. Individual AUs should be able to account for all 

materials in their possession, regardless of its form (solid, liquid, or gas), its container 

(stock vial, dispersed in samples, etc.) or its placement into waste in the AU’s laboratory. The 

licensee should be able to account for the location of all materials possessed, whether the 

material is located in a secured laboratory cabinet, a locked sample container in a refrigerator or 

freezer, or in appropriate waste containers awaiting disposal. The RSO should perform periodic 

update of the total inventory of all unsealed materials possessed under the license. Depending 

on how often unsealed materials are received and used, the periodic update may be weekly, 

monthly, quarterly, or at less frequent intervals. 

NRC regulations applicable to transfers are stated in 10 CFR 30.41. Sample policy transfer 

statements are included in Appendix I of this NUREG. Transfer of licensed materials within the 

facility may require special procedures to ensure proper control. Licensees must consider 

potential contamination of laboratory equipment or components, such as refrigerators and 

freezers, and carefully control the removal of these items for maintenance, repair, or disposal.

Licensees who also possess Radioactive Materials Under a General License or 

an Exemption

In addition to radionuclides that are specifically listed on their license, licensees frequently 

possess radioactive material under a general license or that was distributed to them as an 

exempt quantity or item. 10 CFR Parts 31, 40, and 70 provide information regarding devices 

that may be possessed under a general license. Any person who acquires, receives, 
8-36

possesses, uses, or transfers a device under a general license must do so in accordance with 

the provisions of the general license. A specific licensee may also possess material under a 

general license. A specific license does not automatically remove general licensee status nor 

automatically “move” licensed material from the general license to the specific license. The 

NRC recognizes that multiple authorizations can create some confusion; therefore, a specific 

licensee always has the option of receiving and possessing radioactive materials that “qualify” 

for a general license by adding these to its specific license as described in 10 CFR 31.5(c)(8)(iii) 

or other applicable regulations. Persons who wish to convert items from a general license to a 

specific license should discuss the process with the NRC.

Some facilities may have separate laboratories or locations that use material for in-vitro assay 

that may be possessed under the general license in 10 CFR 31.11. Each location is a separate 

general license from the other. The multiple locations are not considered to operate under a 

single general license and are not considered part of the specific license. In accordance with 

10 CFR 31.11(c)(1), the possession limit of 7.4 MBq [200 μCi], only applies to a total amount of 

iodine-125 (I-125), iodine-131 (I-131), selenium-75 (Se-75), and iron-59 (Fe-59) used or stored 

in one location.

Similarly, radioactive material received by a specific licensee under an exemption from the 

requirements for a license is not subject to the terms and conditions of the specific license. 

NRC does not require that licensees possess or control these types of devices under the 

provisions of their specific license.

Receipt, inventory, transfer, and disposal records must be maintained for the times specified in 

Table 8-3. Typically, these records contain the following types of information:

• radionuclide and the activity (in units of becquerels or curies) of byproduct material in 

each sealed source

• manufacturer’s or distributor’s name, model number, and serial number (if appropriate) 

of each device containing byproduct material

• location of each sealed source and device

• for inventories, the date of the inventory and name and signature of the individual 

conducting the inventory

• for materials transferred or disposed of, the date of the transfer or disposal, the name 

and license number of the recipient, and a description of the affected radioactive 

material (e.g., radionuclide, activity, manufacturer’s or distributor’s name and model 

number, serial number)

Manufacturers and distributors must also make reports to regulatory agencies for exempt and 

general licensed devices distributed so that these can be accounted for and registered in 

some cases. Please refer to NUREG–1556, Vol. No. 8, “Consolidated Guidance About 

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

NUREG–1556, Vol. 16, “Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Licenses Authorizing Distribution to General Licensees.”
8-37

Table 8-3. Record Maintenance

Type of Record How Long Record Must Be Maintained

Receipt For as long as the material is possessed and for 3 years 

following transfer or disposal of the material

Inventory For 3 years from the date of the inventory in accordance with 

license conditions

Transfer For 3 years after each transfer unless a specific requirement 

dictates otherwise

Disposal Until NRC terminates the license

Important to 

Decommissioning*

Until the site is released for unrestricted use

*See Section 8.5.2, “Financial Assurance and Recordkeeping for Decommissioning,” for more details.

Information about locations where licensed material is used or stored are among the records 

important to decommissioning and required by 10 CFR 30.35(g). See also Section 8.5.2, 

“Financial Assurance and Record Keeping for Decommissioning.”

Category 1 and Category 2 sources listed in Appendix E to 10 CFR Part 20 (i.e., nationally 

tracked sources) must be tracked in the NSTS in accordance with 10 CFR 20.2207. The 

regulations in 10 CFR 20.2207 require that each licensee that manufactures, transfers, 

receives, disassembles, or disposes of a nationally tracked source shall complete and submit a 

National Source Tracking Transaction Report (NSTTR) to the NRC. The NSTTRs are 

maintained in the NSTS, a secure computer system that tracks Category 1 and Category 2 

nationally tracked sources from the time they are manufactured or imported through the time of 

their disposal or export, or until the source activity decays to below Category 2.

There are additional security requirements for shipment and transfer of a Category 1 and 

Category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part 37. Prior to 

transferring Category 1 or Category 2 quantities of radioactive material, licensees must use 

NRC’s license verification system (or contact the licensing authority) to verify that the recipient 

licensee is authorized to possess the radioactive material. 

Licensees that ship Category 1 or Category 2 quantities of radioactive material must preplan 

and coordinate such shipments in accordance with 10 CFR 37.75. Shipments of Category 1 

quantities are also subject to the 10 CFR 37.77 advance notification requirements. For 

additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may

be subject to review and inspection.

Response from Applicant:

• If applicable, provide the following statement: “We will comply with the National Source 

Tracking System (NSTS) reporting requirement, as described in 10 CFR 20.2207.”
8-38

AND

• State that: “We will develop, implement, and maintain procedures for ensuring 

accountability of license materials at all times.”

AND

• Provide either of the following:

— State that: “Physical inventories will be conducted at intervals not to exceed 

6 months, to account for all sealed sources and devices received and possessed 

under the license. Records of inventory will be maintained for a period of 3 years 

from the date of each inventory and will include the radionuclides, quantities, 

manufacturer’s name and model numbers, and the date of the inventory.”

OR

— Provide a description of the procedures for ensuring that no sealed sources have 

been lost, stolen, or misplaced.

Notes:

• No response is needed from applicants for package opening procedures. Package

opening procedures will be reviewed during NRC inspections.

• Alternative responses will be evaluated using the guidance in this section.

References:

• NUREG–1516, “Management of Radioactive Material Safety Programs at 

Medical Facilities”

• NUREG–1556, Vol. No. 8, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Exempt Distribution Licenses”

• NUREG–1556, Vol. 16, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Licenses Authorizing Distribution to 

General Licensees”

● NCRP Report No. 114, “Maintaining Radiation Protection Records” (1992)

• NCRP Report No. 105, “Radiation Protection For Medical and Allied Health 

Personnel” (1989)

• NCRP 127, “Operational Radiation Safety Program” (1998)
8-39

8.10.4 Occupational Dose

Regulations: 10 CFR 19.13, 10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203,

10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1501, 10 CFR 20.1502,

10 CFR 20.1703, 10 CFR 20.2104, 10 CFR 20.2105, 10 CFR 20.2106, 10 CFR 20.2206,

10 CFR Part 20, Appendix B

Criteria: Licensees must evaluate the potential occupational exposure of all workers and 

monitor occupational exposure.

The use of individual monitoring devices for external dose is required, pursuant to 

10 CFR 20.1502(a), for

• adults who are likely to receive an annual dose from sources external to the body in 

excess of any of the following (each evaluated separately)

— 5 mSv [0.5 rem] deep-dose equivalent

— 15 mSv [1.5 rems] lens (of the eye) dose equivalent

— 50 mSv [5 rems] shallow-dose equivalent to the skin

— 50 mSv [5 rems] shallow-dose equivalent to any extremity

• minors who are likely to receive an annual dose from sources external to the body in 

excess of any of the following (each evaluated separately)

— 1.0 mSv [0.1 rem] deep-dose equivalent

— 1.5 mSv [0.15 rem] lens (of the eye) dose equivalent

— 5 mSv [0.5 rem] shallow-dose equivalent to the skin

— 5 mSv [0.5 rem] shallow-dose equivalent to any extremity

• declared pregnant women who are likely to receive a dose from radiation sources 

external to the body during the entire pregnancy in excess of 1.0 mSv [0.1 rem]

deep-dose equivalent

• individuals entering a high or very high radiation area

Internal exposure monitoring is required pursuant to 10 CFR 20.1502(b), for the following:

• adults likely to receive, in 1 year, an intake in excess of 10 percent of the applicable 

Annual Limit on Intake (ALI) for ingestion and inhalation

• minors likely to receive, in 1 year, a committed effective dose equivalent in excess of 

1.0 mSv [0.1 rem] and declared pregnant women likely to receive, during the entire 

pregnancy, a committed effective dose equivalent in excess of 1 mSv [0.1 rem]
8-40

Total effective dose equivalent (TEDE) equals the effective dose equivalent (for external 

exposures) plus the committed effective dose equivalent (for internal exposures).

Figure 8-8. Annual Dose Limits for Adult Radiation Workers

Some manufacturers and distributors must report individual monitoring. Licensees that process, 

manufacture, or distribute above the quantities specified in 10 CFR 20.2206(a)(7) must file a 

report annually.

Discussion: If an adult radiation worker is likely to receive in 1 year a dose greater than 10

percent of any applicable limit (see Figure 8-8 for annual dose limits), monitoring for 

occupational exposure is required. Monitoring is required for minors and declared pregnant 

women as shown in the criteria section. The licensee should perform an evaluation of the dose 

the individual is likely to receive prior to allowing the individual to receive the dose. This 

evaluation need not be made for every individual; evaluations can be made for employees with 

similar job functions or work areas. 

If this prospective evaluation shows that an adult individual’s dose is not likely to exceed 

10 percent of any applicable limit, there are no recordkeeping or reporting requirements in 

regard to the individual’s exposure. For individuals who have received doses at other facilities 

in the current year, the previous dose need not be considered in this prospective evaluation. 

Only dose that could be received at the facility performing the evaluation need be considered 

when determining the need for monitoring, and associated recordkeeping and reporting. If it 

was determined that monitoring was not required and a subsequent evaluation shows that the 

10 percent threshold has or will be exceeded, the dose received when monitoring was not 

provided should be estimated, recorded, and reported. These estimates can be based on any 

combination of work location radiation monitoring or survey results, monitoring results of 

individuals in similar work situations, or other estimates to produce a “best estimate” of the 

actual dose received.

Licensees should use NRC Form 4, “Cumulative Occupational Dose History,” and NRC Form 5, 

“Occupational Dose Record for a Monitoring Period,” to record individual dose. If monitoring is 

not required to demonstrate compliance with all limits but is required relative to one or more 

specific limits, the licensee should enter “N/A,” for “Not Applicable” in the blocks on 

NRC Forms 4 and 5 to indicate the areas for which monitoring was not required (e.g., extremity 
8-41

or skin doses). Where monitoring was provided but not measurable, the licensee should enter 

“ND,” for “Not Detectable.”

If the prospective evaluation shows that the individual adult is likely to exceed 10 percent of an 

applicable limit, then monitoring, regardless of the actual dose received, is required. If air 

sampling or bioassay is required, discussion of air sampling or bioassay should provide enough 

detail so that the NRC staff is assured that appropriate steps will be taken to manage and 

monitor such exposure. Licensees must provide individual radiation exposure data to each 

worker as required by 10 CFR 19.13.

Licensees should also perform prospective evaluations of the doses that may be received by 

occupationally exposed minors and declared pregnant women. As with individual adult workers, 

licensees must supply and require the use of individual monitoring devices to monitor external 

exposures and monitor the occupational intake of radioactive material when the results of 

prospective dose evaluations exceed the doses specified in 10 CFR 20.1502.

When personnel dosimeters that require processing to determine the radiation dose are used to 

comply with the individual monitoring requirement for external doses in 10 CFR 20.1502(a), 

dosimeters must be processed and evaluated by a NVLAP-accredited processor

(10 CFR 20.1501(d)). The exchange frequency for dosimeters is typically monthly or quarterly. 

Applicants should consult with their NVLAP-accredited processor for its recommendations for 

exchange frequency and proper use of the dosimeter.

For guidance about methodologies for determination of internal occupational dose and 

summation of occupational dose, refer to Table 8-4.

Table 8-4. Guidance on Personnel Monitoring and Bioassay

Regulatory Guide 8.7, 

Revision 4

Instructions for Recording and Reporting Occupational Radiation 

Exposure Data

Regulatory Guide 8.9, 

Revision 1

Acceptable Concepts, Models, Equations, and Assumptions for a 

Bioassay Program

Regulatory Guide 8.20, 

Revision 2

Applications of Bioassay for Radioiodine

Regulatory Guide 8.21, 

Revision 1

Health Physics Surveys for Byproduct Material at NRC-Licensed 

Processing and Manufacturing Plants

Regulatory Guide 8.23, 

Revision 1

Radiation Safety Surveys at Medical Institutions

Regulatory Guide 8.25, 

Revision 1

Air Sampling in the Workplace

Regulatory Guide 8.32 Criteria for Establishing a Tritium Bioassay Program 

Regulatory Guide 8.34 Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses

Regulatory Guide 8.35, 

Revision 1

Planned Special Exposures
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Table 8-4. Guidance on Personnel Monitoring and Bioassay

Regulatory Guide 8.36 Radiation Dose to the Embryo/Fetus

Regulatory Guide 8.37 ALARA Levels for Effluents from Materials Facilities

ANSI N13.30- 2011 Performance Criteria for Radiobioassay

Information Notice 2000-10 Recent Events Resulting in Extremity Exposures Exceeding 

Regulatory Limits

For those manufacturers and distributors that need to report individual monitoring, the report 

must be submitted by April 30 for the preceding year. Please see www.reirs.com for details on 

how to submit this report.

Additional Reference for Further Reading:

• U.S. Department of Energy (DOE) G 441.1-1C, “Radiation Protection Programs Guide,”

May 19, 2008

Response from Applicant: Provide one of the following statements:

“We will maintain, for inspection by the NRC, documentation demonstrating that unmonitored 

individuals are not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502.”

OR

“We will monitor individuals in accordance with the guidance in Section 8.10.4, “Radiation 

Safety Program–Occupational Dose” in NUREG–1556, Vol. 12, Rev. 1, “Consolidated Guidance 

About Materials Licenses: Program-Specific Guidance About Possession Licenses for 

Manufacturing and Distribution.””

OR, IN LIEU OF THESE STATEMENTS,

Provide a description of an alternative method for demonstrating compliance with the 

referenced regulations.

Reference: The National Institute of Standards and Technology maintains a directory of 

laboratories that are NVLAP-accredited at http://ts.nist.gov/standards/scopes/dosim.htm.

Note:

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

• Some licensees choose to provide personnel dosimetry to their workers for reasons 

other than compliance with NRC requirements (e.g., to respond to worker requests).
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8.10.5 Public Dose

Regulations: 10 CFR 20.1003; 10 CFR 20.1101(d); 10 CFR 20.1301; 10 CFR 20.1302;

10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.2107

Criteria: Licensees must ensure that licensed material will be used, transported, stored, and

disposed of in such a way that members of the public will not receive more than 1 mSv 

[100 mrem] in a year and that the dose in any unrestricted area will not exceed 0.02 mSv 

[2 mrem] in any 1 hour period from licensed operations in accordance with 10 CFR 20.1301(a).

In addition, licensees must ensure that air emissions of radioactive material to the environment, 

excluding radon-222 and its daughters, will not result in exposures to individual members of the 

public in excess of 0.1 mSv [10 mrem] (TEDE) in a year from those emissions in accordance 

with 10 CFR 20.1101(d).

Discussion: Public dose is defined in 10 CFR 20.1003 as “the dose received by a member of 

the public from exposure to radiation or to radioactive material released by a licensee, or to any 

other source of radiation under the control of a licensee.” Public dose excludes occupational

dose, or doses received from background radiation and medical procedures. Whether the dose 

to an individual is an occupational dose or a public dose depends on the individual’s assigned 

duties. It does not depend on the area (restricted, controlled, or unrestricted) where the 

individual is when he or she receives the dose.

There are both external exposure components and internal exposure components of public 

dose. The licensee should review all possible internal and external exposure pathways and 

decide which are applicable to its operations.

For guidance about accepted methodologies for determining dose to members of the public, 

please refer to Appendix J of this NUREG, Guidance for Demonstrating That Individual 

Members of the Public Will Not Receive Doses Exceeding the Allowable Limits.

Figure 8-9 shows the steps to calculate the annual dose to an individual member of the public.

There are many possible internal dose pathways that contribute to the TEDE. The TEDE can, 

however, be broken down into three major dose pathway groups:

• airborne radioactive material (e.g., inhalation)

• waterborne radioactive material (e.g., ingestion)

• external radioactive exposure (e.g., source)

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

its operations.

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

The extent and frequency of monitoring will depend upon each licensee’s needs. For 

additional guidance regarding monitoring of effluents, refer to Section 8.10.7, Radiation Safety 

Program–Surveys and Leak Tests.

The regulations in 10 CFR 20.2107, “Records of dose to individual members of the public,” 

require that licensees maintain records sufficient to demonstrate compliance with the dose limits 

for members of the public until the Commission terminates the license.
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Figure 8-9. Calculating Public Dose. Steps to calculate the annual dose to an individual 

member of the public (see Appendix J of this NUREG for more information about 

occupancy factors).

Response from Applicant:

No response is required from the applicant, but records and written materials documenting 

compliance will be examined during inspection. During NRC inspections, licensees must be 

able to demonstrate, by measurement or calculation, that the total effective dose equivalent to 

the individual likely to receive the highest dose from the licensed operation does not exceed the 

annual limit for members of the public.

See Appendix J of this NUREG for examples of methods to demonstrate compliance.

8.10.6 Safe Use of Radionuclides and Emergency Procedures

Regulations: 10 CFR 19.11(a)(3); 10 CFR 20.1101; 10 CFR 20.1406; 10 CFR 20.1801;

10 CFR 20.1802; 10 CFR 20.1902–1905; 10 CFR 20.2201–2203; 10 CFR 21.21;

10 CFR 30.32(i); 10 CFR 30.34(e); 10 CFR 30.50; 10 CFR 30.72; 10 CFR 32.11; 10 CFR 32.23; 

10 CFR 32.27; 10 CFR 32.31; 10 CFR 37 (Subpart B); 10 CFR 37.21; 10 CFR 37.45;

10 CFR 37.49; 10 CFR 40.41(e); 10 CFR 40.60; 10 CFR 70.22; 10 CFR 70.32(b);

10 CFR 70.50
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Criteria: Licensees must do all of the following:

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

• Ensure security of licensed material.

• Make the required notifications of events to NRC.

Discussion: Licensees are responsible for developing and implementing procedures to ensure 

the security and safe possession and use of all licensed material from the time it arrives at their 

facility until it is used, transferred, or disposed. Licensees should develop, implement, and 

maintain written procedures to ensure safe possession and use of licensed material, and the 

procedures should also include operational and administrative guidelines. The written 

procedures should provide reasonable assurance that only appropriately trained personnel will 

handle and use licensed material without undue hazard to workers or members of the public.

Licensees that possess an aggregated Category 1 or Category 2 quantity of radioactive 

material, listed in Appendix A to 10 CFR Part 37, must also establish, implement, and maintain 

its access authorization program; coordinate, to the extent practicable, with local law 

enforcement authorities, for responding to threats to the licensee’s facility; and be able to 

monitor, detect without delay, assess, and respond to any unauthorized entries into 

security zones.

General Safety and Manufacturing Process Procedures

The written procedures should include the following elements:

• contamination controls

• waste disposal practices

• personnel and area monitoring (including limits)

• use of protective clothing and equipment

• recordkeeping requirements

• reporting requirements

• responsibilities

These procedures should include policies for:

• frequency of personnel monitoring

• use of appropriate shielding (see Figure 8-10)

• frequent change of gloves to minimize exposure to the individual and to avoid spread of 

contamination in work areas

Applicants should also develop product and radionuclide-specific procedures, based on the 

respective hazards associated with the products and radionuclides. General safety guidelines 

are described in Appendix K of this NUREG, “General Topics for Safe Possession and Use of 

Radioactive Materials and Model Emergency Procedures.” Applicants should use these 

guidelines to develop procedures for the safe use of radionuclides.

Licensees must identify all areas that require posting, in accordance with 10 CFR 20.1902, 

unless they meet the criteria listed in 10 CFR 20.1903. Also, containers of licensed material 

(including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, unless they 

meet the exemptions in 10 CFR 20.1905.
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Figure 8-10. Use of Appropriate Shielding. This worker is using high-density plastic 

shielding, which is appropriate for radionuclides that emit beta radiation.

Manufacturing Process and Procedures

The licensee’s manufacturing process and procedures should ensure that the product is 

manufactured and distributed in accordance with the manufacturer’s quality assurance program. 

For registered sealed sources and devices, the manufacture and distribution should be in 

accordance with the representations made in the application and with the statements contained 

in the registration certificate for the product. 

Security Procedures

All licensed materials stored in controlled or unrestricted areas must be secured from 

unauthorized access or removal so that individuals who may not be knowledgeable about 

radioactive materials cannot be exposed to or contaminated by the material, and so that 

unauthorized individuals cannot take the material. When any licensed materials are in use in 

controlled or unrestricted areas, they must be under constant surveillance so that the radiation 

worker can prevent others from becoming contaminated by or exposed to the material and 

prevent unauthorized persons from removing the material from the area. Acceptable methods 

for securing material will vary from one facility to another. Some alternatives used by licensees 

include (i) storage and use of licensed materials only in restricted areas; (ii) limiting access to an 

entire facility or building or portion of the building only to radiation workers; (iii) providing storage 

areas that can be locked to prevent access to the material; and (iv) implementing procedures 

that require a radiation worker to be within “line of sight” of the materials whenever licensed 

materials are in use. Applicants should develop procedures that clearly state acceptable 

methods to secure licensed material at their facility. Particular attention may need to be paid to 

security procedures at facilities that may have unusual needs due to the activities performed, 

such as hot cells, animal care facilities, and waste processing facilities.
8-47

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things,

• in accordance with 10 CFR 37.21(a), establish, implement, and maintain its access 

authorization program in accordance with the requirements of 10 CFR Part 37, 

Subpart B;

• in accordance with 10 CFR 37.45, coordinate with their local law enforcement agency 

(LLEA) for responding to threats to a licensee’s facility; and

• in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices.

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may

be subject to review and inspection.

Emergency Procedures

Accidents and emergencies can happen during any operation with radionuclides, including their 

transportation, use, production processes, transfer, and disposal. Such incidents can result in 

contamination or release of material to the environment and unintended radiation exposure to 

workers and members of the public. In addition, loss or theft of licensed material, sabotage, 

fires, floods, etc., can adversely affect the safety of personnel and members of the public.

Therefore, it is necessary to develop written procedures to minimize, as much as possible, the 

effect of these incidents on personnel, members of the public, and the environment. Applicants 

that plan to possess quantities of material in excess of the applicable amounts listed in 

10 CFR 30.72 Schedule C, or greater than 2 curies of unsealed plutonium may also be required 

to submit an “Emergency Plan for Responding to a Release,” pursuant to 10 CFR 30.32(i) and 

10 CFR 70.22(i). Applicants who need to submit an “Emergency Plan” should refer to 

Regulatory Guide 3.67, Revision 1, “Standard Format and Content for Emergency Plans for 

Fuel Cycle and Materials Facilities” and 10 CFR 70.22(i)(3) for assistance in preparing an 

emergency plan. 

Applicants should establish written procedures to handle events ranging from a minor spill to a 

major accident that may require intervention by outside emergency response personnel. These 

procedures should include provisions for immediate response, after-hours notification, handling 

of each type of emergency, equipment, and the appropriate roles of users and the radiation 

safety staff. Except for minor spills or releases of radioactivity that can be controlled and 

cleaned up by the user, the licensee’s staff should have a clear understanding of their limitations 

in an emergency, along with step-by-step instructions and clear guidelines for whom to contact.

Typical notification and reporting requirements are described in Appendix L of this NUREG. 

Applicants should use these guidelines to develop procedures for notification and reporting of 

accidents and emergencies.
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Licensees should have a sufficient number of appropriate and calibrated radiation survey 

instruments readily available. Emergency spill kits should be strategically placed in well-marked 

locations for use by all users and the radiation safety staff. All equipment should be inspected 

periodically for proper operation and replenished as necessary. Appendix K of this NUREG

includes model emergency procedures. Applicants may adopt these procedures or develop 

their own, incorporating the safety features included in these model procedures.

Collection of Bioassay Samples

In the event of an emergency where an individual became contaminated and radioactive 

material was taken into the body through skin absorption or other means, or an individual is 

suspected of having ingested or inhaled radioactive material, an estimate of the amount of 

material taken into the body may be required. Frequently, this estimate is made by performing 

bioassay of the individual. Bioassays may be performed through direct methods, such as whole 

body counting or thyroid counting, where the radioactive material in the body can be directly 

measured using appropriate instruments. Bioassays may also be performed through indirect 

means by sampling urine or other excreta from the body and calculating the intake from the 

amount of material detected in the samples, the time between suspected intake and sample 

collection, and knowledge of the rate of excretion of the compound or radionuclide from the 

body. While there are many ways to perform the calculations, including using computer models, 

the method of calculation is only as good as the quality of the samples and analyses performed. 

Because a dose estimate may be required, bioassay procedures for a suspected intake may 

differ from those in a routine bioassay screening program, and the radiation safety program

should include procedures and equipment for appropriate sample collection in an 

emergency. The following items should be considered in developing procedures for 

collecting bioassay samples:

• type of bioassay that must be performed (i.e., direct or indirect)

• number of samples or data points to be collected

• date and time of initial sample collection

• frequency of sampling (e.g., only once, hourly, daily, weekly)

• size of the sample to be collected (e.g., 24-hour urine collection, single-void grab 

sample, 1-liter breathing volume)

• ease/difficulty of sample collection

• need for written instructions to be provided to the sample collector (who may be the 

contaminated individual)

Response from Applicant: 

The applicant should provide the following statements:

“Procedures for safe use, security of materials, and emergencies will be developed and 

documented before receipt of licensed material. Operating and emergency procedures will be 

implemented and maintained.”
8-49

AND

“Procedures will be revised only if (i) the changes are reviewed and approved by the licensee 

management and the RSO in writing; (ii) the licensee staff is provided training in the revised 

procedures prior to implementation; (iii) the changes are in compliance with NRC regulations 

and the license; and (iv) the changes do not degrade the effectiveness of the program.”

AND

Additionally, for licensees requiring an “Emergency Plan” under 10 CFR 30.32(i) and 30.72 or 

10 CFR 70.22(i), applicants should submit it as a separate part of the application.

8.10.7 Surveys and Leak Tests 

Regulations: 10 CFR 20.1501; 10 CFR 20.2103; 10 CFR Part 20, Subpart K; 10 CFR 30.53;

10 CFR 32.59; 10 CFR 40.63; 10 CFR 70.56

Criteria: Licensees are required by 10 CFR 20.1501 to make surveys of potential radiological 

hazards in their workplace. NRC requires testing to determine whether there is any radioactive 

leakage from sealed sources. Licensees must maintain records of surveys and leak test results 

in accordance with license conditions and NRC regulations.

Discussion: Survey is defined as an evaluation of radiological conditions and potential hazards 

incident to the production, use, transfer, release, disposal, or presence of radioactive material or 

other sources of radiation (see Figure 8-11). These evaluations may be measurements 

(e.g., radiation levels measured with a survey instrument or results of wipe tests for 

contamination), calculations, or a combination of measurements and calculations. The selection 

and proper use of appropriate instruments is one of the most important factors in ensuring that 

surveys accurately assess the radiological conditions. Licensees should also use surveys to 

plan work in areas where licensed material or radiation exists and to evaluate doses to workers 

and individual members of the public. In certain cases, environmental monitoring may be 

required to demonstrate compliance with 10 CFR Part 20. In order to meet regulatory 

requirements for surveying, measurements of radiological quantities should be understood in 

terms of their properties (i.e., alpha, beta, and gamma) and compared to the appropriate limits.

Figure 8-11. Types of Surveys. There are many different types of surveys performed by 

manufacturer and distribution licensees.
8-50

Radiation surveys are used to detect and evaluate contamination of:

• facilities

• equipment

• personnel (during use, possession, transfer, or disposal of licensed material) 

(see Figure 8-12)

• restricted and unrestricted areas

• products produced

Figure 8-12. Personnel Surveys. Users of unsealed licensed material should check 

themselves for contamination (frisk) before leaving the area of use.

As required by 10 CFR 20.1501, surveys will be performed when it is reasonable, under the 

circumstances, to evaluate a radiological hazard and when necessary for the licensee to comply 

with the regulations. Many different types of surveys may need to be performed because of the 

particular use of licensed materials. Typical surveys may include:

• surveys for radioactive contamination that could be present on surfaces of floors, walls, 

laboratory furniture, production line, and equipment

• measurements of radioactive material concentrations in air for areas where radioactive 

materials are handled or processed in unsealed form and where operations could 

expose workers to the inhalation of radioactive material or where licensed material is or 

could be released to unrestricted areas

• measurements of radioactive material concentrations in water released to the 

environment or to the sanitary sewer
8-51

• bioassays to determine the kinds, quantities, or concentration—and in some cases, the 

location of—radioactive material in the human body (a bioassay can be made by direct 

measurement, in vivo counting, or by analysis and evaluation of material excreted or 

removed from the human body)

• surveys of external radiation exposure levels in both restricted and unrestricted areas

The frequency of routine surveys depends on the nature, quantity, and use of radioactive 

materials, as well as the specific facilities, equipment, and procedures designed to protect the 

worker from external and internal exposure. Also, the frequency of the survey depends on the 

type of survey, such as those listed above (see Appendix M of this NUREG, “Radiation Safety 

Survey Topics”).

Not all instruments can measure a given type of radiation. The presence of other radiation may 

interfere with a detector’s ability to measure the radiation of interest. Correct use of radiation 

detection and measurements is an important aspect of any radiation safety program. 

Regulations in 10 CFR Part 20 do not specify limits for surface contamination. Each applicant 

should propose and justify the removable surface contamination limits that will be allowed

before decontamination will be performed in each work area. Contamination checks are 

required before distributing fabricated sources. Appendix M of this NUREG contains 

contamination limits that are acceptable to NRC.

Sealed Source and Plated Foil Leak Tests

Sealed sources and devices approved by the NRC or an Agreement State and located and 

used according to their SSD registration certificates usually pose little risk of contamination. 

Leak tests performed, as specified in the SSD registration certificate, should identify defective 

sources. Leaking sources must be withdrawn immediately from use and decontaminated, 

repaired, or disposed of in accordance with the disposal requirements in Subpart K of 

10 CFR Part 20. These steps minimize the spread of contamination and reduce radioactive 

waste associated with decontamination efforts. Other efforts to minimize radioactive waste do 

not apply to programs using only sealed sources and devices that have not leaked.

When issued, a license will require performance of leak tests of sealed and plated foil sources 

at intervals, as approved by NRC or an Agreement State and specified by the SSD registration 

certificate. The measurement of the leak test sample is a quantitative analysis requiring that 

instrumentation used to analyze the sample be capable of detecting 185 Bq [0.005 μCi] of the 

radionuclide contained in the sealed or plated foil source.

Manufacturers, distributors, consultants, and other organizations may be authorized by NRC or 

an Agreement State to either to perform the entire leak test sequence on behalf of licensees or 

provide leak test kits to licensees. In the latter case, the licensee is expected to take the leak 

test sample using the instructions from the manufacturer, (or distributor) of the sealed source or 

plated foil, and the leak test kit supplier. The licensee returns the sample to the leak-test 

service provider for evaluation and reporting results. Leak test samples should be collected at 

the most accessible area where contamination would accumulate if the sealed source were 

leaking. The NRC or an Agreement State may, in a license condition, specifically authorize 

manufacturers and distributors to conduct the entire leak-test sequence themselves.
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Because the types, forms, and quantities of licensed materials in sealed sources can vary 

significantly for applicants, leak test requirements usually are specified in a license condition. 

Typically, leak tests are not required if:

• sources contain only hydrogen-3 (tritium)

• sources contain only byproduct material with a half-life of less than 30 days

• sources contain only a radioactive gas

• sources contain 3.7 MBq [100 μCi] or less of beta-emitting or gamma-emitting material 

or 370 kBq [10 μCi] or less of alpha emitting material

• sources are stored and not being used (but must be leak tested before use or transfer, 

or if stored more than 10 years)

For more information regarding leak tests, see Appendix N of this NUREG, “Model Leak 

Test Program.”

Service Licenses

If a licensee wants to perform leak tests for its customers, it must obtain a service license. This 

may also be accomplished by amending an existing license. For more information regarding

service license applications, see NUREG–1556, Vol. 18, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Service Provider Licenses.”

Response from Applicant: Do one of the following:

• State: “We will survey our facility and maintain contamination levels in accordance 

with the survey frequencies and contamination levels published in Appendix M to 

NUREG–1556, Vol. 12, Rev. 1, “Consolidated Guidance about Material Licenses: 

Program-Specific Guidance about Possession Licenses for Manufacturing and 

Distribution.”” If applicable, state, “We will perform contamination checks on all 

fabricated sealed sources prior to distribution. Also, leak tests will be performed at the 

intervals approved by NRC or an Agreement State and specified in the SSD registration 

certificate. Leak tests will be performed by an organization authorized by NRC or an 

Agreement State to provide leak testing services to other licensees or leak tests may be 

collected by the licensee using the sealed source or plated foil manufacturer’s,

distributor’s, and leak test kit supplier’s instructions. Such leak test kits should be 

supplied by an organization authorized by the NRC or an Agreement State to provide 

leak testing services.”

OR

• State: “We will survey our facility and maintain contamination levels in accordance 

with the survey frequencies and contamination levels published in Appendix M to 

NUREG–1556, Vol. 12, Rev. 1, “Consolidated Guidance about Material Licenses: 

Program-Specific Guidance about Possession Licenses for Manufacturing and 

Distribution.”” If applicable, state, “We will perform contamination checks on all fabricated 

sealed sources prior to distribution. Also, leak tests will be performed at the intervals 

approved by NRC or an Agreement State and specified in the SSD registration certificate.
8-53

We will follow the model procedures in Appendix N of NUREG–1556, Vol. 12, Rev. 1, 

“Consolidated Guidance about Material Licenses: Program-Specific Guidance about 

Possession Licenses for Manufacturing and Distribution.””

OR

• Submit a description of alternative equipment and procedures to evaluate radiological 

hazards at the applicant’s facility, in accordance with 10 CFR 20.1501, and for 

determining whether there is radioactive leakage from sealed sources or plated foils. If 

applicable, state, “We will perform contamination checks on all fabricated sealed sources 

prior to distribution. Also, leak tests will be performed at the intervals approved by NRC 

or an Agreement State and specified in the SSD registration certificate.”

Notes:

• Alternative responses will be reviewed using the guidance in this section.

• If a sealed source or plated foil is added to an existing license, that license might already 

authorize the licensee to perform the entire leak test sequence. In this case, the 

licensee may perform the leak testing on the sealed source or plated foil according to the 

procedures previously approved on its license.

Reference: See the Notice of Availability (on inside front cover of this report) to obtain a copy 

of NUREG–1556, Vol. 18, “Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Service Provider Licenses.”

8.10.8 Maintenance

Regulations: 10 CFR 20.1101; 10 CFR 30.34(e); 10 CFR 40.41(e); 10 CFR 70.32(b)

Criteria: Maintenance of devices and facilities should be planned and carried out as frequently 

as needed, using ALARA principles. Individuals performing maintenance should be trained in 

the procedures they implement. Procedures should be written to account for the skills of the 

implementing personnel. Ordinarily, individuals handling unshielded materials should have up 

to 40 hours of classroom and on-the-job training in radiation safety. Instructors should be more 

extensively qualified than the staff they teach.

Discussion: Maintenance of equipment and facilities is necessary in order to produce a quality 

product safely and efficiently and to ensure a safe environment for staff and the public. 

Manufacturing a product incorporating radioactive materials is an additional hazard, requiring 

attention to detail when incorporating maintenance information into procedures. Licensee staff 

should ensure that materials in the process stream are properly shielded, located, and protected 

to minimize the hazard to maintenance staff. Maintenance staff should be aware of the hazards 

and the procedures to minimize their exposure to radioactive materials that are possessed and 

used to control the manufacturing process. As examples (i) a radionuclide hot cell should have 

its contents moved or shielded before any maintenance requiring entry is begun, and the staff 

should survey the hot cell working area prior to entry; and (ii) a maintenance procedure should 

direct the shutdown and lockout of applicable process control gauges before beginning work in 

the area, which may be in the direct beam of the gauge, whether inside the process vessel or 

outside the vessel. Maintenance procedures should be prepared with the use of engineering 

controls first, using ALARA principles and administrative controls, as needed.
8-54

Response from Applicant: No response is required in the application process. The results of 

actions taken in the maintenance and repair of facilities and equipment process will be reviewed 

during inspection.

8.10.9 Transportation

Regulations: 10 CFR 20.1101; 10 CFR Part 20, Appendix G; 10 CFR 30.41; 10 CFR 30.51;

10 CFR Part 37 (Subpart D); 10 CFR 40.51; 10 CFR 40.61; 10 CFR 70.41; 10 CFR 70.51; 

10 CFR 71.5; 10 CFR 71.12; 10 CFR 71.13; 10 CFR 71.14; 10 CFR 71.37; 10 CFR 71.38;

10 CFR 71.47; 10 CFR 71.87, Subpart H of 10 CFR Part 71; 49 CFR Parts 171-178

Criteria: Applicants who will transport or ship licensed material, including radioactive waste, 

must develop, implement, and maintain safety programs for transport of radioactive material to 

ensure compliance with NRC and DOT regulations. In accordance with 10 CFR Part 37 

(Subpart D), licensees must also preplan, coordinate, and provide advance notification of the 

shipment of Category 1 quantities of radioactive material and coordinate the shipment of 

Category 2 quantities of radioactive material., 

Discussion: Licensed material, including radioactive waste, must be packaged and transported 

in accordance with NRC and DOT requirements if the transportation involves common carriers 

or the use of public highways. Licensees should develop and maintain their own radiation 

safety procedures for transporting licensed material within their own facilities if it does not 

involve the use of public highways. 

Packages shipped by licensees frequently meet the “Limited quantity” criteria, as described in 

49 CFR 173.421 and, therefore, may be subject to other less restrictive DOT requirements 

(e.g., 49 CFR 173.422 and 173.424; also see Appendix O of this NUREG for more information)

than packages requiring a DOT White I, Yellow II, or Yellow III label. Under DOT regulations, 

each person (shipper or carrier) involved in the transportation of radioactive materials is 

considered a “hazardous materials employee” who must receive appropriate training for the jobs 

they perform related to transportation every 3 years. Jobs related to transportation include 

activities such as packaging radioactive materials, loading and securing the package on a 

vehicle, or preparing paperwork for shipping the material.

Licensees should consider the safety of all individuals who may handle or may come into 

contact with the packages containing licensed material. Therefore, the primary considerations 

in packaging licensed material should be to ensure that the package integrity is not 

compromised during transport and that radiation levels (including removable contamination 

levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, but 

are also ALARA.

All domestic shipping papers and labels must be in SI units only or must be in SI units first, with 

English units in parentheses.

Licensees shipping radioactive waste for disposal must prepare appropriate documentation, as 

specified in 10 CFR Part 20, Appendix G.

The general license in 10 CFR 71.17 provides the authorization used by most licensees to 

transport, or offer for transport, packages of radioactive material and specifies certain 

conditions. Transporting licensed materials originating at some facilities involves quantities of 

radioactive material that require a Type B package. The manufacturer (or service licensee) who
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is subject to the provisions of 10 CFR 71.17 or 10 CFR 71.19, as appropriate, is responsible for

proper packaging of the radioactive materials and compliance with NRC and DOT regulations. 

Licensees who use another manufacturer’s Type B package must ensure that the other 

manufacturer (or service licensee):

• is authorized to possess the licensed material at temporary jobsites (i.e., at the 

facility location)

• actually takes possession of the licensed material under its license

• uses an approved Type B package

• is registered with NRC as a user of the Type B package

• has an NRC-approved QA plan

For each shipment, it must be clear who possesses the licensed material and is responsible for 

proper packaging of the radioactive materials and compliance with NRC and DOT regulations.

If a licensee plans to make shipments of licensed materials in Type B packages on its own, the 

licensee must be registered as a user of the package and have an NRC-approved quality 

assurance (QA) plan, as required under the 10 CFR 71.17 general license. For information 

about QA plans, see Revision 2 of Regulatory Guide 7.10, “Establishing Quality Assurance 

Programs for Packaging Used in the Transport of Radioactive Material,” dated March 2005. For 

further information about registering as a user of a package or submitting a QA program for 

review, contact the NRC’s Office of Nuclear Material Safety and Safeguards, Division of Spent 

Fuel Storage and Transportation, by calling the NRC’s toll free number, 800-368-5642, and 

asking for extension 415-9956. For information about any associated fees, contact the NRC’s 

Office of the Chief Financial Officer, by calling the NRC’s toll free number, 800-368-5642, and 

asking for extension 415-7554.

During an inspection, NRC uses the provisions of 10 CFR 71.5 and a “Memorandum of 

Understanding with DOT on the Transportation of Radioactive Material,” signed June 6, 1979, to 

examine and enforce various DOT requirements listed in Appendix O of this NUREG.

Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive material

are subject to the requirements in 10 CFR Part 37, Subpart D (“Physical protection in transit”).

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.
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Response from Applicant: No response is needed from applicants during the licensing phase. 

However, before making shipments of licensed materials on its own in Type B packages, a 

licensee needs to have registered with NRC as a user of the package and obtained NRC’s 

approval of its QA program. Transportation issues will be reviewed during inspection.

References: “Radioactive Material Regulations Review (December 2008)” is available from the 

DOT at: 

https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/training/hazmat/56526/ramreview200

8.pdf.

The Memorandum of Understanding with DOT on the Transportation of Radioactive Material 

(signed June 8, 1979) is available from the NRC on its public Web site under “Enforcement 

Guidance” at https://www.nrc.gov/about-nrc/regulatory/enforcement/moudot.pdf.

8.10.10 Security Program for Category 1 and Category 2 Radioactive 

Material

Regulations: 10 CFR Part 37

Criteria: Licensees must ensure the security of Category 1 and Category 2 

radioactive material.

Note: The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated

Category 1 or Category 2 quantity of radioactive material. The specific radionuclides subject to 

10 CFR Part 37 requirements are listed in Table 1 of Appendix A to 10 CFR Part 37.

Discussion:

Requirements in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities 

of Radioactive Material”

In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or 

Category 2 quantities of radioactive material must establish, implement, and maintain an access 

authorization program (Subpart B) and a security program (Subpart C) to ensure physical 

protection of the radioactive material.

Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37, 

lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

should refer to this table to determine whether its proposed activities would be subject to the 

10 CFR Part 37 requirements.

Before giving individuals unescorted access to Category 1 or Category 2 quantities of 

radioactive material (as defined in 10 CFR 37.5), licensees must conduct background 

investigations of these individuals, to determine that they are trustworthy and reliable, in 

accordance with 10 CFR 37.25. 

In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to 

monitor and, without delay, detect, assess, and respond to any actual or attempted 

unauthorized access to Category 1 or Category 2 quantities of radioactive material. 
8-57

Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

Category 2 quantities of radioactive materials in transit. These requirements apply to licensees 

delivering such material to a carrier for transport, as well as cases in which licensees are 

transporting such material. Please note that the Subpart D requirements applicable to the 

transport of Category 1 quantities of radioactive material are more stringent than those 

applicable to Category 2 quantities.

Applicants and licensees are required to implement the 10 CFR Part 37 security requirements 

before they take possession of an aggregated Category 1 or Category 2 quantity of 

radioactive material.

Any licensee that has not previously been made subject to the provisions of 10 CFR Part 37, 

Subpart C shall notify the NRC regional office specified in 10 CFR 30.6 in writing at least 

90 days before aggregating radioactive material to a quantity that equals or exceeds the 

Category 2 threshold. Pursuant to 10 CFR 37.43(b), as part of the security program, the 

licensee must develop and maintain written procedures that document how the requirements of 

Subpart C will be met. These written procedures may be subject to NRC review and inspection.

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best practices 

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Response from Applicant: No response is required from an applicant or licensee. 

Compliance with access authorization and security program requirements may be reviewed 

during NRC inspections.

8.11 Item 11: Waste Management

Regulations: 10 CFR 20.1301; 10 CFR 20.1904; 10 CFR 20, Subpart K; 10 CFR Part 20, 

Appendices B and G; 10 CFR 30.51; 10 CFR 37.11(c); 10 CFR 40.61; 10 CFR 61.52; 

10 CFR 70.51

Criteria: Radioactive waste must be disposed of in accordance with regulatory requirements 

and license conditions. Appropriate records of waste disposal must be maintained.

Discussion: Radioactive waste is normally generated when conducting licensed activities. 

Such waste may include used or unused radioactive material, or unusable items contaminated 

with radioactive material (e.g., absorbent paper, gloves). Licensees may not receive radioactive 

waste from other licensees for processing, storage, or disposal, unless the NRC specifically 

authorized them to do so.

All radioactive waste must be stored in appropriate containers until its disposal. The integrity of 

the waste containers must be assured. Radioactive waste containers must be appropriately 

labeled. All radioactive waste must be secured against unauthorized access or removal. 

Licensees may implement procedures to reduce the volume of radioactive waste for final 

disposal in an authorized low-level radioactive waste (LLW) disposal facility. These procedures 

include volume reduction by segregating, consolidating, compacting, or allowing certain 
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short-lived radioactive waste to be stored until it has decayed. Waste compaction or other 

treatments can reduce the volume of radioactive waste, but such processes may pose 

additional radiological hazards (e.g., airborne radioactivity) to workers and members of the 

public. The program should include adequate safety procedures to protect workers, members 

of the public, and the environment.

In accordance with regulations in 10 CFR 20.2001–20.2008, the NRC requires licensees to 

dispose of radioactive waste generated at their facilities through one or more of the 

following methods:

• decay-in-storage (DIS)

• release into sanitary sewerage

• transfer to an authorized recipient

• disposal of waste as if it were not radioactive (specific wastes)

• obtaining prior approval of NRC of any alternate method

• release in effluents to unrestricted areas, other than into sanitary sewerage

• incineration

Licensees may choose one or more of these methods to dispose of their radioactive waste. The

NRC has observed that most of the possession licenses for manufacturing and distribution store 

or dispose of radioactive waste through a combination of the first four methods because of the 

types and amounts of licensed materials these facilities use. Applicants that want to dispose of 

radioactive waste by incineration should refer to Policy and Guidance Directive PG 8-10, 

“Disposal of Incineration Ash as Ordinary Waste,” issued January 1997. Applicants should note 

that compliance with NRC regulations does not relieve them of their responsibility to comply with 

any other applicable Federal, State, or local regulations. Furthermore, some of the radioactive 

waste may also include additional hazards (e.g., biohazard or chemical hazard). Such waste is 

called “mixed waste,” and its storage and disposal must also comply with all other applicable 

Federal, State, and local regulatory requirements.

Applicants should describe their program for management and disposal of radioactive waste. 

The program should include procedures for handling of waste, safe and secure storage, 

characterization, minimization, and disposal of radioactive waste. Appropriate training should 

be provided to waste handlers. Regulations require that licensees maintain all appropriate 

records of disposal of radioactive waste. The U.S. Environmental Protection Agency issued 

guidance for developing a comprehensive program to reduce hazardous waste that, in many 

instances, may also include radioactive waste. The NRC transmitted these guidelines to 

licensees in IN 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste Generators on 

the Elements of a Waste Minimization Program,” dated March 25, 1994.

The NRC has developed guidance for such extended interim storage of waste, 

discussed below. 

Disposal by Decay-in-Storage 

The NRC has concluded that materials with half-lives of less than or equal to 120 days are 

appropriate for DIS. The holding time of the waste should be based on the radionuclides, 

half-life, and the activity present when the waste was placed into storage. Such waste may be 

disposed of as ordinary trash if radiation surveys of the waste indicate that radiation levels are 

indistinguishable from background. The surveys should be performed with an appropriate 

radiation detection meter set on its most sensitive scale in a low background area and without 
8-59

any interposed shielding. In accordance with 10 CFR 20.1904(b), all radiation labels must be 

defaced or removed from containers and packages before disposal as ordinary trash, except for 

radiation labels on materials that are within containers and that will be managed as biomedical 

waste after they have been released. If the decayed waste is compacted, all labels that are

visible in the compacted mass must also be defaced or removed. Applicants must maintain 

accurate records of such disposals.

Applicants should ensure that adequate space and facilities are available for the storage of such 

waste. Licensees can minimize the need for storage space, if the waste is segregated 

according to physical half-life. Waste-containing radionuclides of physical half-lives within a 

certain range may be stored in one container and allowed to decay in the container.

Procedures for management of such waste should include methods of segregation, surveys 

before disposal, and maintenance of records of disposal. Records should include the date 

when the waste was put in storage for decay, date of disposal, and results of final survey before 

disposal as ordinary trash. Appendix P of this NUREG provides a model procedure for disposal 

of radioactive waste by DIS, which incorporates the above guidelines.

Release Into Sanitary Sewerage

10 CFR 20.2003 authorizes disposal of radioactive waste by release into a public sanitary 

sewerage system if each of the following conditions is met:

• Material is readily soluble (or is readily dispersible biological material) in water.

• The quantity of licensed material or other radioactive material that the licensee releases 

into the sewer in one month divided by the average monthly volume of water released 

into the sewer does not exceed the concentration specified in Table 3 of Appendix B, 

“Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides 

for Occupational Exposure; Effluent Concentrations; Concentrations for Release to 

Sewerage,” to 10 CFR Part 20.

• If more than one radionuclide is released, the sum of the ratios of the average monthly 

discharge of a radionuclide to the corresponding limit in Table 3 of Appendix B to 

10 CFR Part 20 cannot exceed unity.

• Total quantity of licensed material and other radioactive material released into the 

sanitary sewerage system in a year does not exceed 185 GBq [5 Ci] of H-3, 37 GBq 

[1 Ci] of C-14, and 37 GBq [1 Ci] of all other radionuclides combined.

Licensees are responsible for demonstrating that licensed materials discharged into the public 

sewerage system are readily soluble in water. NRC IN 94-07, “Solubility Criteria for Liquid 

Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR Part 20,” dated 

January 28, 1994, provides acceptable criteria for evaluating solubility of wastes released to the 

sewer. Careful consideration should be given to the possibility of reconcentration of 

radionuclides released into the sewer. NRC alerted licensees to the potentially significant 

problem of reconcentration of radionuclides released to sanitary sewage systems in IN 84-94, 

“Reconcentration of Radionuclides Involving Discharges into Sanitary Sewage Systems 

Permitted under 10 CFR 20.303 [now 10 CFR 20.2003],” dated December 21, 1984.

Applicants should provide procedures that will ensure that all releases of radioactive waste into 

the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the 
8-60

monthly and annual limits specified in regulations. Licensees are required to maintain accurate 

records of all releases of licensed material into the sanitary sewerage. Appendix P of this 

NUREG provides a model program for disposal of radioactive waste through sanitary sewer.

The regulations at 10 CFR 20.2003 are not applicable for releases to a private sewerage 

treatment system, a septic system, or leach fields. Licensees may make releases to these 

systems as effluents released to unrestricted areas under 10 CFR 20.1301, “Dose limits for 

individual members of the public.” However, if licensed material is released to a private 

sewerage treatment system, septic system, or leach field, the sludge or other solids from these 

systems may become contaminated with radioactive material. Such sludges may be required to 

be disposed of as radioactive waste, using one of the methods described in Section 8.11, 

“Waste Management,” of this document.

Release into Air and Water

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

in 10 CFR 20.1302(b)(2) (see Figure 8-13). The applicant should describe the monitoring and 

control mechanisms in place to ensure compliance with the requirements. Applicants are 

reminded of the “constraint” on air emissions of radioactive material required by 

10 CFR 20.1101(d), which effectively reduces the limits specified in 10 CFR 20.1302(b)(2) for 

release of gaseous effluents by a factor of 10. Applicants considering release of radioactive 

material into air and water should review Regulatory Guide 8.37, “ALARA Levels for Effluents 

From Materials Facilities,” dated July 1993, which deals with the application of ALARA in 

controlling gaseous and liquid effluents and references documents with acceptable methods of 

effluent monitoring. Regulatory Guide 4-20, “Constraint on Releases of Airborne Radioactive 

Materials to the Environment for Licensees Other than Power Reactors,” dated April 2012, also 

contains useful information. 

Figure 8-13. Air and Water Effluents from a Manufacturing Facility. Also note the fence, 

creating a “controlled area.”
8-61

Transfer to an Authorized Recipient

Licensees may transfer radioactive waste to an authorized recipient for disposal. The licensee 

is responsible for verifying that the intended recipient is authorized to receive the radioactive 

waste before making any shipment. The waste must be packaged in approved containers for 

shipment, and each container must identify the radionuclides and the amounts contained in the 

waste. Additionally, packages must comply with the requirements of the particular burial site’s 

license and State requirements. Each shipment must comply with all applicable NRC and 

DOT requirements.

In some cases, the waste handling contractor may provide guidance to the licensee for 

packaging and transportation requirements; however, the licensee is ultimately responsible for 

ensuring compliance with all applicable regulatory requirements.

The shipper must provide all information required by the NRC’s Uniform Low-Level Radioactive 

Waste Manifest, and transfer this recorded manifest information to the intended recipient, in 

accordance with Appendix G to 10 CFR Part 20. Each shipping manifest must include a 

certification by the waste generator, as specified in Section II of Appendix G. Each person 

involved in the transfer for disposal and disposal of waste, including waste generator, waste 

collector, waste processor, and disposal facility operator, must comply with requirements 

specified in Section III of Appendix G.

Disposal of Specific Waste As If It Were Not Radioactive

The following radioactive wastes may be disposed of as nonradioactive waste, pursuant to 

10 CFR 20.2005, “Disposal of specific wastes:”

• liquid scintillation media (including vials and other items contaminated with liquid 

scintillation media) containing no more than 1.85 kBq [0.05 μCi] of H-3 or C-14 per gram 

of the medium

• animal carcasses or animal tissue containing no more than 1.85 kBq [0.05 μCi] of H-3 or 

C-14 per gram averaged over the weight of the entire animal

Applicants should have procedures to ensure that the above limits are not exceeded and that 

animal tissue or carcasses containing licensed material are disposed of in a way that will not 

permit their use either as food for humans or animals. Applicants must maintain accurate 

records of these disposals.

Alternate Methods

Applicants may also request alternate methods under 10 CFR 20.2002, “Method for obtaining 

approval of proposed disposal procedures,” for the disposal of radioactive waste generated at 

their facilities. Such requests must describe the waste containing licensed material, including 

the physical and chemical properties that may be important to assess risks associated with the 

waste, and the proposed manner and conditions of waste disposal. Additionally, the applicant 

must submit its analysis and evaluation of pertinent information on the nature of the 

environment, the nature and location of other affected facilities, and procedures to ensure that 

radiation doses are maintained ALARA and within regulatory limits. An applicant cannot make 

such disposals until the NRC has reviewed and approved the request.
8-62

Extended Interim Storage

The NRC does not consider interim or long-term storage as a substitute for final disposal of 

LLW. Licensees should exhaust all possible alternatives for disposal of radioactive waste and 

rely upon on-site extended interim storage of radioactive waste only as a last resort. The 

protection of workers and the public is enhanced by disposal rather than storage of waste.

Licensees may also find it more economical to dispose of radioactive waste than to store it on

site because, as the available capacity decreases, the cost of disposal of radioactive waste may 

continue to increase. Other than DIS, LLW should be stored only when disposal capacity is 

unavailable and for no longer than is necessary. NRC IN 90-09, “Extended Interim Storage of

Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees,” dated February 5, 1990, 

provides guidance to licensees for requesting an amendment to authorize extended interim 

storage of LLW. This information was updated by NRC Regulatory Issue Summary (RIS) 

2008-12, “Considerations For Extended Interim Storage Of Low-Level Radioactive Waste By 

Fuel Cycle And Materials Licensees,” dated May 9, 2008. In addition, the NRC issued 

Regulatory Issue Summary 2011-09, “Available Resources Associated With Extended Storage 

Of Low-Level Radioactive Waste,” dated August 16, 2011, which refers to other helpful 

guidance documents.

Note: Before licensed activities are transferred or assigned in accordance with 

10 CFR 30.34(b), 10 CFR 40.46, or 10 CFR 70.36, if licensees are authorized to possess 

byproduct material with a half-life greater than 120 days in an unsealed form, source material 

in an unsealed form, or special nuclear material, the licensees must, in accordance with 

10 CFR 30.51(e), 10 CFR 40.61(e), or10 CFR 70.51(b)(1)&(2), respectively, transfer the 

following records to the new licensee:

• records of disposal of licensed material made under:

— 10 CFR 20.2002, “Method for obtaining approval of proposed 

disposal procedures”

— 10 CFR 20.2003, “Disposal by release into sanitary sewerage”

— 10 CFR 20.2004, “Treatment or disposal by incineration”

— 10 CFR 20.2005, “Disposal of specific wastes”

• records required by 20.2103(b)(4) of the results of measurements and calculations used 

to evaluate the release of radioactive effluents to the environment 

Because of the difficulties and costs associated with disposal of sealed sources, applicants 

should preplan the disposal.
8-63

In accordance with 10 CFR 37.11(c), a licensee that possesses radioactive waste that contains 

Category 1 or Category 2 quantities of radioactive material as defined in 10 CFR 37.5 is 

exempt from the requirements of 10 CFR Part 37, Subparts B, C, and D. However, any 

radioactive waste that contains discrete sources, ion-exchange resins, or activated material 

that weighs less than 2,000 kg [4,409 lbs] is not exempt from the requirements of 

10 CFR Part 37. For additional guidance on implementing 10 CFR Part 37 requirements, see 

NUREG–2155, “Implementation Guidance for 10 CFR Part 37, “Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material.”” Additional information 

regarding best practices for protection of risk-significant radioactive material is available in 

NUREG–2166, “Physical Security Best Practices for the Protection of Risk-Significant 

Radioactive Material.”

A licensee possessing radioactive waste that is exempt under 10 CFR 37.11(c) from the 

requirements of 10 CFR Part 37, Subparts B, C, and D must implement the following 

requirements to secure the radioactive waste:

• use continuous physical barriers that allow access to the radioactive waste only through 

established access control points;

• use a locked door or gate with monitored alarm at the access control point;

• assess and respond to each actual or attempted unauthorized access to determine 

whether an actual or attempted theft, sabotage, or diversion occurred; and

• immediately notify the LLEA and request an armed response from the LLEA upon 

determination that there was an actual or attempted theft, sabotage, or diversion of 

the radioactive waste that contains Category 1 or Category 2 quantities of 

radioactive material.

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

Response from Applicant:

State that: “We will use the model waste procedures and guidelines published in Appendix P

to NUREG–1556, Vol. 12, Rev. 1, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution.””

OR

If the applicant wishes to use only selected model procedures and guidelines, state that, “We 

will use the [specify either (i) decay-in-storage or (ii) disposal of liquids into sanitary sewerage]

model waste procedures that are published in Appendix P to NUREG–1556, Vol. 12, Rev 1., 

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

Possession Licenses for Manufacturing and Distribution.””

AND

If the applicant wishes to compact or incinerate radioactive waste, provide the requested 

information concerning these activities as stated in Appendix P of this NUREG.
8-64

OR

If needed, the applicant should request authorization for extended interim storage of waste.

Alternative responses will be reviewed using the guidance in this section.

Notes:

• Applicant should use the references listed below for guidance and submit the required 

information with the application.

• Applicants do not need to provide information to the NRC if they plan to dispose of LLW 

via transfer to an authorized recipient or to dispose of liquid scintillation media or animals 

References:

• Information Notice 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste

Generators on the Elements of a Waste Minimization Program,” dated March 1994

• Information Notice 94-07, “Solubility Criteria for Liquid Effluent Releases to Sanitary 

Sewerage Under the Revised 10 CFR Part 20,” dated January 1994

• Information Notice 84-94, “Reconcentration of Radionuclides Involving Discharges into 

Sanitary Sewage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003),” 

dated December 1984

• Information Notice 90-09, “Extended Interim Storage of Low-Level Radioactive Waste by 

Fuel Cycle and Materials Licensees,” dated February 1990

• Regulatory Issue Summary 2008-12, “Considerations For Extended Interim Storage Of 

Low-Level Radioactive Waste By Fuel Cycle And Materials Licensees”

• Regulatory Issue Summary 2011-09, “Available Resources Associated With Extended 

Storage Of Low-Level Radioactive Waste”

• Policy and Guidance Directive PG 8-10, “Disposal of Incineration Ash as Ordinary 

Waste,” January 1997, ADAMS Accession Nos. ML003744979 and ML003752866 and 

Addendum, ADAMS Accession Nos. ML003744984 and ML003744988.

• NRC Regulatory Issue Summary 2004-17, Revision 1, “Revised Decay-In-Storage 

Provisions For The Storage Of Radioactive Waste Containing Byproduct Material,”

September 2005

• State and Tribal Communication Letter FSME 12-025 dated March 13, 2012 

“Clarification of the Authorization for Alternative Disposal of Material Issued Under 

10 CFR 20.2002 and Exemption Provisions in 10 CFR” (ADAMS Accession 

No. ML12065A038)

• Division of Waste Management and Environmental Protection, Environmental and 

Performance Assessment Directorate, Operating Procedures, EPPAD 3.5 (Draft for 
8-65

Interim Use), “Review, Approval, and Documentation of Low-Activity Waste Disposals in 

Accordance with 10 CFR 20.2002 and 10 CFR 40.13(a),” dated August 2009

• Regulatory Issue Summary 2016-11, “Requests to Dispose of Very Low-Level 

Radioactive Waste Pursuant to 10 CFR 20.2002,” November 13, 2016

Information Notices and Regulatory Issue Summaries are available at https://www.nrc.gov.

8.12 Item 12: License Fees

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

the fee enclosed with the application.

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

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

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

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

Fees.Resource@nrc.gov.

8.13 Item 13: Certification

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

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

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

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

management’s commitment to and responsibility for the radiation safety program. The NRC will 

return all unsigned applications for proper signature.

Notes:

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

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

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

license and therefore, will become binding and conditions to the license.

9-1

9 LICENSE AMENDMENTS AND RENEWALS

It is the licensee’s obligation to keep the license current. If any of the information provided in 

the original application is to be modified or changed, the licensee must submit an application for 

a license amendment before the change takes place. The change is not in effect until the 

amendment has been issued. Also, to continue the license after its expiration date, the licensee 

must submit an application for a license renewal at least 30 days before the expiration date 

[see Title 10 of Code of Federal Regulations (10 CFR) 2.109(a), 10 CFR 30.36(a), 

10 CFR 40.42(a), 10 CFR 70.38(a)].

Applicants for license amendment or renewal should do the following:

• Use the most recent guidance in preparing an amendment or renewal request.

• Submit either an U.S. Nuclear Regulatory Commission (NRC) Form 313 or a letter 

requesting amendment or renewal.

• Provide the license number and docket number.

• For renewals, provide a complete and up-to-date application, including all required 

program elements outlined in Appendix B of this NUREG. Training documentation for 

personnel currently listed on the license does not need to be submitted as part of the 

renewal application.

9.1 Timely Notification of Transfer of Control

Regulation: 10 CFR 30.34(b); 10 CFR 40.41(b); 10 CFR 70.32(a)(3)

Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

consent before transferring control of the license, also referred to as a “change of ownership” or 

“transferring the license.”

Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

transfers. Although it is not the NRC’s intent to interfere with the business decisions of 

licensees, it is necessary for licensees to obtain prior NRC written consent to ensure 

the following:

• Radioactive materials are possessed, used, or controlled only by persons who have 

valid NRC licenses or Agreement State licenses.

• Materials are properly handled and secured.

• Persons using these materials are capable, competent, and committed to implementing

appropriate radiological controls.

• A clear chain of custody is established to identify who is responsible for disposition of 

records and licensed material.

• The transferee has the financial resources to decommission the license, if necessary.

• Public health and safety are not compromised by the use of such materials.
9-2

• Adequate financial assurance is provided for compliance with the applicable NRC 

requirements, if required.

Response from Applicant: No response is required from an applicant for a new license. 

However, current licensees should refer to NUREG–1556, Volume 15, “Consolidated Guidance 

About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving 

Byproduct, Source, or Special Nuclear Materials Licenses,” for more information about transfer 

of control (e.g., ownership.).

Reference: For further information, see Regulatory Issue Summary (RIS) 2014-08, Revision 1, 

“Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials 

Licenses,” dated May 5, 2016, which can be found on the NRC’s Generic Communications Web 

page under “Regulatory Issue Summaries”: https://www.nrc.gov/reading-rm/doc-collections/gencomm/.
10-1

10 APPLICATIONS FOR EXEMPTIONS

Regulations: Title 10 of the Code of Federal Regulations (10 CFR) 19.31; 10 CFR 20.2301;

10 CFR 30.11; 10 CFR 40.14; 10 CFR 70.17

Criteria: Licensees may request exemptions from U.S. Nuclear Regulatory Commission (NRC) 

regulations. The licensee must demonstrate that the exemption is authorized by law; will not 

endanger life, property, or the common defense and security; and is otherwise in the public 

interest. Licensees may also use existing specific exemptions outlined in 10 CFR regulations if 

they meet the established criteria.

Discussion: Various sections of the NRC’s regulations address requests for exemptions 

(e.g., 10 CFR 19.31, “Application for exemptions”; 10 CFR 20.2301, “Applications for 

exemptions”; 10 CFR 30.11, “Specific exemptions”; 10 CFR 40.14, “Specific exemptions”; 

10 CFR 70.11, “Specific exemptions”). These regulations state that the NRC may grant an 

exemption, acting on its own initiative or on an application from an interested person.

Exemptions are not intended to revise regulations or apply to large classes of licensees and are 

generally limited to unique situations. Requests for exemptions submitted to the NRC must 

identify the regulation for which the exemption is being requested and include a justification for 

the requested exemption.

Unless the NRC has granted an exemption in writing, licensees must comply with all 

applicable regulations.

11-1

11 TERMINATION OF ACTIVITIES

Regulations: Title 10 of the Code of Federal Regulations (10 CFR) 20.1401; 

10 CFR 20.1402; 10 CFR 20.1403; 10 CFR 20.1404; 10 CFR 20.1405; 10 CFR 20.1406; 

10 CFR 20.2002; 10 CFR 20.2003; 10 CFR 20.2004; 10 CFR 20.2005; 10 CFR 30.34(b);

10 CFR 30.35(g); 10 CFR 30.36; 10 CFR 30.51; 10 CFR 40.36(f); 10 CFR 40.42;

10 CFR 40.46; 10 CFR 40.61(d); 10 CFR 70.25(g); 10 CFR 70.36; 10 CFR 70.38;

10 CFR 70.51

Criteria: The licensee must do the following:

• Notify the U.S. Nuclear Regulatory Commission (NRC), in writing, within 60 days of the 

occurrence of any of the following:

— expiration of its license

— a decision to permanently cease principal activities1 at the entire site

— for licensees subject to 10 CFR 30.36, a decision to permanently cease principal 

activities in any separate building or outdoor area that contains residual 

radioactivity such that the building or area is unsuitable for release according to 

NRC requirements

— for licensees subject to 10 CFR 40.42 or 10 CFR 70.38, a decision to 

permanently cease principal activities in any separate building or outdoor area

— no principal activities under the license have been conducted for a period of

24 months

— no principal activities have been conducted for a period of 24 months in any

separate building or outdoor area that contains residual radioactivity such 

that the building or outdoor area is unsuitable for release according to 

NRC requirements

• Submit a decommissioning plan, if required by 10 CFR 30.36(g), 10 CFR 40.42(g), or 

10 CFR 70.38(g).

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

and (j), or 10 CFR 70.38(h) and (j).

 

1Principal activities’ are activities which are essential to achieving the purpose(s) for which the license was issued or 

amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to 

decontamination or decommissioning are not principal activities.
11-2

• Submit to the appropriate NRC regional office a completed NRC Form 314, “Certificate 

of Disposition of Materials” (or equivalent information), and information demonstrating 

that the premises are suitable for release for unrestricted use (e.g., results of final 

surveys and results of leak tests of sealed sources).

• Before a license is terminated, send records important to decommissioning that are 

required by 10 CFR 30.35(g), 10 CFR 40.36(f) and 10 CFR 70.25(g) to the

appropriate NRC regional office in accordance with 10 CFR 30.51(f), 10 CFR 40.61(f), or 

10 CFR 70.51(a)(3), respectively.

• Before a license is terminated, send records of disposal of licensed material made under 

10 CFR 20.2002, 10 CFR 20.2003, 20.2004, or 20.2005, and the results of 

measurements and calculations used to evaluate the release of radioactive effluents 

to the environment to the appropriate NRC regional office in accordance with 

10 CFR 30.51(d), 10 CFR 40.61(d), or 10 CFR 70.51(a)(1) and (2), if authorized to 

possess byproduct material with a half-life greater than 120 days in an unsealed form,

source material in an unsealed form, or special nuclear material, respectively.

Discussion: To comply with the above criteria, before a licensee can decide whether it must 

notify the NRC under 10 CFR 30.36(d), 10 CFR 40.42(d), or 10 CFR 70.38(d), the licensee 

must determine whether residual radioactivity is present and, if so, whether the levels make the 

building or outdoor area unsuitable for release, according to NRC requirements. A licensee’s 

determination that a facility is not contaminated is subject to verification by NRC inspection.

The permanent cessation of principal activities in an individual room or laboratory may require 

the licensee to notify the NRC if no other licensed activities are being performed in the building. 

For information about requirements that apply to the timeliness of decommissioning, 

see Regulatory Issue Summary (RIS) 2015-19, Rev. 1, “Decommissioning Timeliness Rule 

Implementation and Associated Regulatory Relief,” dated September 27, 2016, which can be 

found on the NRC’s Generic Communications Web page under “Regulatory Issue Summaries”: 

https://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2015/.

For guidance on the disposition of licensed material, see Section 8.11 “Waste Management.” 

For guidance on decommissioning records, see Section 8.5.2, “Financial Assurance and 

Recordkeeping for Decommissioning.”

NUREG–1757, “Consolidated Decommissioning Guidance,” contains the current regulatory 

guidance concerning decommissioning of facilities and termination of licenses. Licensees that 

have large facilities to decommission should review NUREG–1575, “(MARSSIM).” The 

computer code “DandD” offers an acceptable method for calculating screening values to 

demonstrate compliance with the unrestricted dose limits. Supplemental information on the 

implementation of the final rule on radiological criteria for license termination was published in 

the Federal Register (63 FR 64132) on November 18, 1998. 

Supplemental information on the implementation of the final rule on radiological criteria for 

license termination also was published in the Federal Register on December 7, 1999,

(64 FR 68395) which addresses screening values in soils for the most common radionuclides, 

and in the Federal Register on June 13, 2000, (65 FR 37186) for screening values for building 

surfaces and soils contaminated with radionuclides not addressed in the prior Federal 

Register notices.
11-3

Response from Applicant: The applicant is not required to submit a response to the NRC 

during the initial application. The licensee’s obligations in this matter begin when the license 

expires or at the time the licensee ceases operations, whichever is earlier. These obligations 

are to undertake the necessary decommissioning activities, to submit NRC Form 314 or 

equivalent information, and to perform any other actions summarized in “Criteria” above.

Reference: NRC Form 314 is available at https://www.nrc.gov/reading-rm/doccollections/forms/

APPENDIX A

U.S. NUCLEAR REGULATORY COMMISSION FORM 313

A–1

U.S. Nuclear Regulatory Commission Form 313

Please use the most current version of this form, which may be found at:

https://www.nrc.gov/reading-rm/doc-collections/forms/nrc313.pdf

APPENDIX B

SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

ITEMS 5 THROUGH 11 OF U.S. NUCLEAR REGULATORY COMMISSION 

FORM 313

B–1

Suggested Format for Providing Information Requested in 

Items 5 through 11 of U.S. Nuclear Regulatory Commission Form 313

The table below is designed to help applicants develop their applications. It may also be used 

as a License Reviewer Checklist for applications for Manufacturing and Distribution licenses. A 

box in a column () indicates that the licensee may agree to use a model procedure, or if not 

using a model procedure, the licensee is then expected to describe its program or submit its 

procedures for the particular item. 

For broad scope usage applications, refer to NUREG–1556, Vol. 11, “Consolidated Guidance 

About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope,” 

issued April 1999.

Table B–1. License Reviewer Checklist

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

5. RADIOACTIVE MATERIAL

Unsealed or Sealed Sources, or Both

For unsealed materials, do the following: N/A 

• For each radionuclide, provide the element name with 

mass number, chemical and/or physical form, and 

maximum requested possession limit.

— For potentially volatile materials (e.g., I-125, I-131, H-3, 

Kr-85), specify whether the material will be free (volatile) 

or bound (non-volatile) and the requested possession 

limit for each form.

For sealed radioactive materials, do the following: N/A 

— Identify each radionuclide (element name and mass 

number) that will be used, and specify the maximum 

activity per source. Also, specify the maximum number 

of sources or total activity of each radionuclide.

— Provide the manufacturer’s or distributor’s name 

and model number for each sealed source and 

device requested.

— Confirm that each sealed source, device, and source 

and device combination is registered as an approved 

sealed source or device by NRC or an Agreement State

and will be possessed and used in accordance with the 

conditions specified in the registration certificate. 

Provide the SSD registration certificate number, 

if available
B–2

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

5. RADIOACTIVE MATERIAL (Continued)

Unsealed or Sealed Sources, or Both (Continued)

For each sealed source, device, and source and device 

combination that is not registered, provide the applicable 

information, as described in 10 CFR 30.32(g) and 32.210.

For Both Unsealed and Sealed Sources, do 

the following:

N/A 

— Identify the largest quantity of each radionuclide to be 

possessed at one time under the license, including 

receipts, in-process materials, and waste.

— In accordance with 10 CFR 30.32(i), applications to 

possess radioactive materials in unsealed form, on foils 

or plated sources, or sealed in glass in excess of the 

quantities listed in 10 CFR 30.72, must include either of 

the following:

— an evaluation showing that the maximum offsite dose 

caused by a release of radioactive materials would not 

exceed 0.01 Sv [1 rem] effective dose equivalent or 

0.05 Sv [5 rem] to the thyroid

OR

— an emergency plan for responding to the release, in 

accordance with the criteria listed in

10 CFR 30.32(i)(3)

— In accordance with 10 CFR 70.22(i), applications to 

possess in excess of 2 curies of plutonium in unsealed 

form or on foils or plated sources must contain either of 

the following:

— an evaluation showing that the maximum dose to a 

member of the public offsite due to a release of 

radioactive materials would not exceed 0.01 Sv [1 rem]

effective dose equivalent
B–3

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

5. RADIOACTIVE MATERIAL (Continued)

Unsealed or Sealed Sources, or Both (Continued)

OR

— an emergency plan for responding to the radiological 

hazards of an accidental release of special nuclear 

material and any associated chemical hazards directly 

incident thereto, in accordance with the criteria listed in

10 CFR 70.22(i)(3)

Financial Assurance and Recordkeeping 

for Decommissioning

 N/A

State the following:

• “Pursuant to 10 CFR 30.35(g), 10 CFR 40.36(f), and 

10 CFR 70.25(g) and 10 CFR 70.51(b)(3), as 

appropriate, we will maintain records important to 

decommissioning and will transfer these records to an 

NRC or Agreement State licensee before licensed 

activities are transferred or assigned, in accordance 

with 10 CFR 30.34(b), 10 CFR 40.46, and 

10 CFR 70.36, as appropriate. Furthermore, pursuant 

to 10 CFR 30.51(f), 10 CFR 40.61(f), and 

10 CFR 70.51(a), as appropriate, prior to license 

termination, we will forward the records required by 

10 CFR 30.35(g), 10 CFR 40.36(f), and 

10 CFR 70.25(g), as appropriate, to the appropriate 

NRC regional office.”

AND

• If financial assurance is required, submit the required 

documents, as described in NUREG–1757, Volume 3, 

“Consolidated Decommissioning Guidance: Financial 

Assurance, Recordkeeping, and Timeliness.”

N/A 

6. PURPOSE FOR WHICH LICENSED MATERIAL WILL BE 

POSSESSED AND USED

• List the specific use or purpose of each radionuclide 

that will be possessed and used.

N/A 
B–4

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

6. PURPOSE FOR WHICH LICENSED MATERIAL WILL BE 

POSSESSED AND USED (Continued)

• Provide the manufacturer name and model number for 

each device, manufactured article, or material that 

becomes the product, by manufacturer and 

model number.

• Provide the manufacturer and model number of each 

sealed source proposed for possession and use or 

incorporation into a manufactured article.

• Submit information requesting authorization to possess 

and use any other licensed materials in support of the 

manufacturing and distribution license.

7. INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING AND EXPERIENCE

RSO

Provide the name of the proposed RSO and information 

demonstrating that the proposed RSO is qualified by 

training and experience.

N/A 

Information should include, as a minimum:

• formal training and education in radiation safety 

(topics covered, duration of training, when training was 

received, identity/location of training provider) (Note: a 

course outline may be provided.)

• experience using licensed materials (types, forms, 

quantities handled, activities performed, duration 

of experience)

• experience performing the duties of a Radiation 

Safety Officer (activities, duration of experience, scope 

of program)

Authorized Users

Provide the name of each proposed AU with the types and 

quantities of licensed material to be possessed or 

possessed and used. Also provide information 

demonstrating that each proposed AU is qualified by 

training and experience to possess and use the requested 

licensed materials.

N/A 
B–5

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

7. INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING AND EXPERIENCE

(Continued)

Authorized Users (Continued)

Information should include, as a minimum:

• formal training and education in radiation safety 

(topics covered, duration of training, when training was 

received, identity/location of training provider) 

(Note: a course outline may be provided.)

• experience using licensed materials (types, forms, 

quantities handled, activities performed, duration 

of experience)

8. TRAINING FOR INDIVIDUALS WORKING IN OR 

FREQUENTING RESTRICTED AREAS

Submit a description of the radiation safety training program, 

including topics covered, groups of workers, assessment of 

training, qualifications of instructors, and the method and 

frequency of training.

N/A 

9. FACILITIES AND EQUIPMENT

Describe the facilities and equipment to be made available 

at each location where radioactive material will be 

possessed or possessed and used (see Appendix F of this 

NUREG for topics to consider). This information should be 

from the point of view of performance criteria. For example, 

state the purpose of any filtration equipment and the 

associated acceptance criteria to accomplish this purpose 

(such as the ventilation flow rate trying to be maintained).

N/A 

Include a description of the areas assigned for the receipt, 

shipping, storage, preparation, security, and measurement 

of radioactive materials.

N/A 

Submit a diagram showing the locations of shielding, the 

proximity of radiation sources to unrestricted areas, areas 

containing flammable or hazardous materials, and other 

items related to radiation safety.

N/A 
B–6

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

9. FACILITIES AND EQUIPMENT (Continued)

• When applicable to facilities where radioactive materials 

may become airborne, the diagrams should contain 

schematic descriptions of the ventilation systems, with 

pertinent airflow rates, pressures, filtration equipment, 

and monitoring systems.

• Diagrams should be drawn to a specified scale, or 

dimensions should be indicated. Sketches or drawing 

should also include a compass directional arrow to 

indicate “North”.

• For facilities where it is anticipated that more than one 

laboratory or room may be used, a generic laboratory or 

room diagram may be submitted

If radioactive materials will be used with animals, include a 

description of the animal-handling housing facilities. 

NUREG–1556, Vol. 7 may also be used as guidance.

Specialized facilities such as waste storage rooms or hot 

labs, and locations of specialized facilities or equipment 

such as waste compactors, hot cells, and shielded storage 

for high activity sources, should be included on the diagram.

10. RADIATION SAFETY PROGRAM

Audit Program

The applicant is not required to, and should not, submit its 

audit program to the NRC for review as part of a license 

application. However, this matter may be reviewed during 

NRC inspections.

N/A 

Radiation Monitoring Instruments

Describe the instrumentation that will be used to perform 

required surveys.

N/A 

AND

State that: “We will use instruments that meet the radiation 

monitoring instrument specifications published in 

Appendix H in NUREG–1556, Volume 12, Rev.1, 

“Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Possession Licenses for 

Manufacturing and Distribution.” We reserve the right to 

upgrade our radiation survey instruments as necessary.”

 N/A
B–7

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

10. RADIATION SAFETY PROGRAM (Continued)

For Instrument Calibration

State that: “Instruments will be calibrated before first use, at

least annually thereafter, and after any repair, by a vendor 

that the NRC or an Agreement State has licensed to 

perform instrument calibration.”

 N/A

OR

State that: “We will implement the model radiation survey 

instrument calibration program published in Appendix H in 

NUREG–1556, Volume 12, Rev. 1, “Consolidated 

Guidance About Materials Licenses: Program-Specific 

Guidance About Possession Licenses for Manufacturing 

and Distribution.””

 N/A

OR

Submit equivalent procedures for instrument calibrations. N/A 

Material Receipt and Accountability

State that: “We will comply with the NSTS reporting 

requirement, as described in 10 CFR 20.2207.”

 

AND

State that: “We will develop, implement, and maintain 

procedures for ensuring accountability of license materials 

at all times.”

 

AND

Provide either of the following

a statement that: “Physical inventories will be conducted at 

intervals not to exceed 6 months, to account for all sealed 

sources and devices received and possessed under the 

license. Records of inventory will be maintained for a 

period of 3 years from the date of each inventory and will 

include the radionuclides, quantities, manufacturer’s name 

and model numbers, and the date of the inventory.”

 N/A

OR

a description of the procedures for ensuring that no sealed 

sources have been lost, stolen, or misplaced

N/A 
B–8

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

10. RADIATION SAFETY PROGRAM (Continued)

Occupational Dose

The applicant should provide one of the 

following statements:

“We will maintain, for inspection by the NRC, documentation 

demonstrating that unmonitored individuals are not likely to 

receive a radiation dose in excess of the limits in 

10 CFR 20.1502.”

 

OR

“We will monitor individuals in accordance with the guidance

in Section 8.10.4, “Radiation Safety Program–Occupational 

Dose” in NUREG–1556, Vol. 12, Rev. 1, “Consolidated 

Guidance About Materials Licenses: Program-Specific 

Guidance About Possession Licenses for Manufacturing 

and Distribution.””

 

OR, IN LIEU OF THESE STATEMENTS,

Provide a description of an alternative method for 

demonstrating compliance with the referenced regulations.

 

Public Dose

No response is required from the applicant, but records and 

written materials documenting compliance will be examined 

during inspection.

N/A N/A

Safe Use of Radionuclides and Emergency Procedures

The applicant should provide the following statements:

“Procedures for safe use, security of materials, and 

emergencies will be developed and documented before 

receipt of licensed material. Operating and emergency 

procedures will be implemented and maintained.”

 N/A

AND

“Procedures will be revised only if (i) the changes are 

reviewed and approved by the licensee management and 

the RSO in writing; (ii) the licensee staff is provided training 

in the revised procedures prior to implementation; (iii) the 

changes are in compliance with NRC regulations and the 

license; and (iv) the changes do not degrade the 

effectiveness of the program.”

 N/A
B–9

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

10. RADIATION SAFETY PROGRAM (Continued)

Safe Use of Radionuclides and Emergency Procedures

(Continued)

AND

If an “Emergency Plan” is required for the license, pursuant 

to 10 CFR 30.32(i) and 30.72 or 10 CFR 70.22(i), submit it 

as a separate part of the application.

N/A 

Surveys and Leak Tests

The applicant should provide one of the 

following statements:

“We will survey our facility and maintain contamination 

levels in accordance with the survey frequencies and 

contamination levels published in Appendix M to 

NUREG–1556, Vol. 12, Rev. 1, “Consolidated Guidance 

about Material Licenses: Program-Specific Guidance about 

Possession Licenses for Manufacturing and Distribution.””

If applicable, state, “We will perform contamination checks 

on all fabricated sealed sources prior to distribution. Also, 

leak tests will be performed at the intervals approved by 

NRC or an Agreement State and specified in the SSD 

registration certificate. Leak tests will be performed by an 

organization authorized by NRC or an Agreement State to 

provide leak testing services to other licensees or leak tests 

may be collected by the licensee using the sealed source or 

plated foil manufacturer’s, distributor’s, and leak test kit 

supplier’ instructions. Such leak test kits should be supplied 

by an organization authorized by the NRC or an Agreement 

State to provide leak testing services.”

 N/A
B–10

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

10. RADIATION SAFETY PROGRAM (Continued)

Surveys and Leak Tests (Continued)

OR

“We will survey our facility and maintain contamination 

levels in accordance with the survey frequencies and 

contamination levels published in Appendix M to 

NUREG–1556, Vol. 12, Rev. 1, “Consolidated Guidance

about Material Licenses: Program-Specific Guidance about 

Possession Licenses for Manufacturing and Distribution.”” 

If applicable, state, “We will perform contamination checks 

on all fabricated sealed sources prior to distribution. Also, 

leak tests will be performed at the intervals approved by 

NRC or an Agreement State and specified in the SSD 

registration certificate. We will follow the model procedures 

in Appendix N of NUREG–1556, Vol. 12, Rev. 1, 

“Consolidated Guidance about Material Licenses: ProgramSpecific Guidance about Possession Licenses for 

Manufacturing and Distribution.””

 N/A

OR

Submit a description of alternative equipment and

procedures to evaluate radiological hazards at the 

applicant’s facility, in accordance with 10 CFR 20.1501 and 

for determining whether there is radioactive leakage from 

sealed sources or plated foils. If applicable, state: “We will 

perform contamination checks on all fabricated sealed 

sources prior to distribution. Also, leak tests will be 

performed at the intervals approved by NRC or an 

Agreement State and specified in the SSD 

registration certificate.”

N/A 

Maintenance

No response is required in the application process. The 

results of actions taken in the maintenance and repair of 

facilities and equipment process will be reviewed 

during inspection.

N/A N/A
B–11

Table B–1. License Reviewer Checklist (Continued)

ITEM 

NO. SUGGESTED RESPONSE

AGREE

TO

USE

DESCRIPTION 

ATTACHED

10. RADIATION SAFETY PROGRAM (Continued)

Transportation

No response is needed from applicants during the licensing 

phase. However, before making shipments of licensed 

materials on its own in Type B packages, a licensee needs 

to have registered with NRC as a user of the package and 

obtained NRC’s approval of its QA program. Transportation 

issues will be reviewed during inspection.

N/A N/A

Security Program For Category 1 and Category 2

Radioactive Material

No response is required from an applicant or licensee. 

Compliance with access authorization and security program 

requirements may be reviewed during NRC inspections.

N/A N/A

11. WASTE MANAGEMENT

The applicant should provide one of the 

following statements:

“We will use the model waste procedures and guidelines 

published in Appendix P to NUREG–1556, Volume 12, 

Rev. 1, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Possession Licenses for 

Manufacturing and Distribution.””

 N/A

OR

“We will use the [specify either (i) decay-in-storage or 

(ii) disposal of liquids into sanitary sewerage] model waste 

procedures that are published in Appendix P to 

NUREG–1556, Volume 12, Rev. 1, “Consolidated 

Guidance About Materials Licenses: Program-Specific 

Guidance About Possession Licenses for Manufacturing 

and Distribution.””

 N/A

AND

If the applicant wishes to compact or incinerate radioactive 

waste, provide the requested information concerning these 

activities as stated in Appendix P of this NUREG.

N/A 

AND/OR

If needed, the applicant should request authorization for 

extended interim storage of waste.

N/A 

APPENDIX C

LICENSE TYPES–GUIDANCE

C–1

License Types–Guidance

The following codes are used for each byproduct material license.

XX (State code)-XXXXX (institution code–a unique identifier for each licensee)-XX 

(sequential number of license for that licensee). Letters that follow the license number on 

distribution licenses include E, G, and MD. No letters indicates a possession license. 

Manufacturer’s Possession License XX-XXXXX-XX

This specific license is issued to a manufacturer to normally possess, use, and manufacture 

licensed material for distribution (includes importers that may not manufacture but want a 

location for distribution) and for use by the licensee in process controls. It can include 

distribution to other specific licensees that are also specifically authorized to receive the 

materials pursuant to their specific license. The manufacturer’s possession license contains 

conditions that prohibit distribution pursuant to Title 10 of the Code of Federal Regulations

(10 CFR) 32.72 and 32.74 and prohibit distribution to general licensees and to persons exempt 

from licensing.

General Distribution License XX-XXXXX-XXG

This specific license is issued to manufacturers and distributors to distribute approved materials 

to persons who are generally licensed to possess and use the materials. This license does not 

authorize the possession of byproduct, source, or special nuclear material.

The most common products distributed to general licensees are

• 10 CFR 32.51, 51a, 52—Certain measuring, gauging, or controlling devices, including 

fixed gauges (e.g., density, thickness), and may include multi-curie sources, gas 

chromatograph electron capture devices (ECDs), X-ray fluorescence or other analytical 

devices, curie-quantity tritium light sources for exit signs, and similar devices. For 

possession and use by persons authorized by a General License pursuant to 

10 CFR 31.5.

• 10 CFR 32.71—Kits for in vitro clinical or laboratory testing (e.g., microcurie quantities of 

H-3, C-14, Fe-55, I-125). For possession and use by persons authorized by a General 

License pursuant to 10 CFR 31.11.

• 10 CFR 40.34(a)—Distribution of industrial products or devices with small amounts of 

depleted uranium for possession and use by persons authorized by a General License 

pursuant to 10 CFR 40.25.

• 10 CFR 70.39—Distribution of calibration or reference sources containing plutonium 

for possession and use by persons authorized by a General License pursuant to 

10 CFR 70.19.

Exempt Distribution License XX-XXXXX-XXE

Specific license to distribute approved materials to persons who are not required to have any 

license in order to possess or use the material. Exempt Distribution is authorized by a specific 
C–2

license issued by U.S. Nuclear Regulatory Commission Headquarters in Washington, D.C. This 

license does not authorize the possession of byproduct, source, or special nuclear material.

Medical Distribution License (XX-XXXXX-XXMD)

10 CFR 32.72 and 32.74

Sources and devices for medical use pursuant to 10 CFR 35.65, 35.400, 35.500, 35.600, and 

35.1000 for radiopharmaceuticals for medical use pursuant to 10 CFR 35.100, 35.200, 35.300, 

and 35.1000 (This license does not authorize the possession of byproduct, source, or special 

nuclear material.)

Manufacturers of medical devices may wish to plan for return shipments of licensed materials. 

Manufacturers of sealed source devices such as eye applicators or bone densitometers may 

wish to provide a return at the end of useful life service. Radiopharmaceutical manufacturers 

may wish to receive spent generator assemblies from their customers and dispose of them by 

decay-in-storage. Returned materials are possessed pursuant to the manufacturer’s 

possession license.
APPENDIX D

RADIATION SAFETY OFFICER DUTIES AND RESPONSIBILITIES

D–1

Radiation Safety Officer Duties and Responsibilities

The radiation safety officer’s (RSO’s) duties and responsibilities include ensuring radiological 

safety, security, and compliance with both U.S. Nuclear Regulatory Commission (NRC) and 

U.S. Department of Transportation (DOT) regulations and the conditions of the license.

Typically, the RSO’s duties and responsibilities include the following:

• Ensure that licensed material possessed by the licensee is limited to the types and 

quantities of licensed material listed on the license.

• Maintain documentation that demonstrates that the dose to individual members of the 

public does not exceed the limit specified in Title 10 of the Code of Federal Regulations

(10 CFR) 20.1301.

• Ensure security of radioactive material, and for licensees possessing an aggregated 

Category 1 or Category 2 quantity of radioactive material, develop and implement a 

security program for radioactive material in accordance with 10 CFR Part 37.

• Post documents as required by 10 CFR Parts 19.11 and 21.6.

• Ensure that licensed material is transported in accordance with applicable NRC and 

DOT requirements.

• Ensure that radiation exposures are as low as is reasonably achievable (ALARA).

• Oversee all activities involving radioactive material, including monitoring and surveys of 

all areas in which radioactive material is possessed or possessed and used.

• Act as liaison with NRC and other regulatory authorities.

• Provide necessary information on all aspects of radiation protection to personnel at 

all levels of responsibility, pursuant to 10 CFR Parts 19 and 20, and any other 

applicable regulations.

• Oversee proper delivery, receipt, and conduct of radiation surveys for all shipments of 

radioactive material arriving at or leaving from the facility, as well as packaging and 

labeling all radioactive material leaving the facility.

• Distribute and process personnel radiation-monitoring equipment, determine the need 

for and evaluate bioassays, monitor personnel radiation exposure and bioassay records 

for trends and high exposures, notify individuals and their supervisors of radiation 

exposures approaching established limits, and recommend appropriate remedial action.

• Conduct training programs and otherwise instruct all personnel in the proper procedures 

for handling radioactive material prior to possession or possession and use, both at 

periodic intervals (refresher training), and as required by changes in procedures, 

equipment, and regulations.
D–2

• Supervise and coordinate the radioactive waste disposal program, including effluent 

monitoring and recordkeeping on waste storage and disposal records.

• Oversee the storage of radioactive material not in current use, including waste.

• Perform or arrange for leak tests on all sealed sources and calibration of radiation 

survey instruments.

• Maintain an inventory of all radionuclides possessed under the license, and limit the 

quantity to the amounts authorized by the license.

• Immediately terminate any unsafe condition or activity that is found to be a threat to 

public health and safety or property.

• Supervise decontamination and recovery operations.

• Maintain other records not specifically designated above (e.g., records of 

receipts; transfers; and surveys, as required by 10 CFR 30.51 and 

10 CFR 20, Subpart L, “Records”).

• Hold periodic meetings with and provide reports to licensee management.

• Perform periodic audits of the Radiation Safety Program to ensure that the licensee is 

complying with (i) all applicable NRC regulations; (ii) the terms and conditions of the 

license (e.g., leak tests; inventories; possession or possession and use limited to 

trained, approved users); (iii) the content and implementation of the Radiation Safety 

Program to achieve occupational doses and doses to members of the public that are 

ALARA, in accordance with 10 CFR 20.1101; and (iv) the requirement that all records be 

properly maintained.

• Ensure that the results of audits, identification of deficiencies, and recommendations for 

change are documented (and maintained for at least 3 years) and provided to

management for review, and ensure that prompt action is taken to correct deficiencies.

• Ensure that the audit results and corrective actions are communicated to all personnel 

who possess or possess and use licensed material.

• Ensure that all incidents, accidents, and personnel exposure to radiation in excess of 

ALARA or Part 20 limits are investigated and reported to NRC and other appropriate 

authorities, if required, within the required time limits.

• Maintain an understanding of, and up-to-date copies of, NRC regulations, the license, 

and revised licensee procedures, and ensure that the license is amended whenever 

there are changes in licensed activities, responsible individuals, or information or 

commitments provided to NRC during the licensing process.

• Develop, implement, maintain, and distribute, as appropriate, up-to-date operating, 

emergency, and security procedures.
D–3

Model Delegation of Authority

Memo To: Radiation Safety Officer

From: Chief Executive Officer

Subject: Delegation of Authority

You, _______________________________, have been appointed radiation safety officer and 

are responsible for ensuring the safe and secure use of radiation. You are responsible for 

managing the Radiation Safety Program; identifying radiation protection problems; initiating, 

recommending, or providing corrective actions; verifying implementation of corrective actions;

stopping unsafe activities; and ensuring compliance with regulations. You are hereby delegated 

the authority necessary to meet those responsibilities, including prohibiting the use of byproduct 

material by employees who do not meet the necessary requirements and shutting down 

operations, when justified, to maintain radiation safety. You are required to notify management 

if staff does not cooperate and does not address radiation safety issues. In addition, you are 

free to raise issues with the U.S. Nuclear Regulatory Commission at any time. It is estimated 

that you will spend _____ hours per week conducting radiation protection activities.

____________________________________ ____________________

Signature of Management Representative Date 

I accept the above responsibilities.

_____________________________________ ____________________

Signature of Radiation Safety Officer Date

cc: Affected department heads

APPENDIX E

RADIATION SAFETY TRAINING

E–1

Radiation Safety Training

This appendix is intended only as a guide for developing a training program. Individuals 

working with radionuclides may not require training on every topic provided. For example, 

housekeeping staff may need to know only what symbols to look for, which waste cans to 

empty, or which areas to enter or avoid. Conversely, laboratory technicians may require 

detailed information on particular topics. As a result, instruction for some individuals may be 

accomplished by providing a simple hand-out, whereas others may require extensive training, 

including an exam to assess retention of the topics presented.

The licensee should determine whether the training succeeded in conveying the desired 

information, and adjust the training program as necessary. This assessment may be performed 

by a test or observation of the individual in the performance of assigned duties. Remedial 

training for missed test questions or other areas of apparent weakness should be conducted or 

additional formal training planned to cover deficient areas.

Frequency of Training

A. before assuming duties with, or in the vicinity of, radioactive materials

B. whenever there is a significant change in duties, regulations, or the terms of the license

C. annually (refresher training)

General Information

A. radiation safety

1. radiation vs. contamination

2. internal vs. external exposure

3. biological effects of radiation

4. as low as is reasonably achievable (ALARA) concept

5. use of time, distance, and shielding to minimize exposure

6. contact dose rates and dose rates at a distance from high activity sources

7. dose reduction responsibilities

B. regulatory requirements

1. Radiation Safety Officer (RSO)

2. material control and accountability

3. personnel dosimetry

4. Radiation Safety Program audits

5. transfer and disposal

6. recordkeeping

7. surveys

8. postings

9. labeling of containers

10. handling and reporting of incidents or events

11. licensing and inspection by U.S. Nuclear Regulatory Commission (NRC)

12. need for complete and accurate information

13. employee protection

14. deliberate misconduct
E–2

Licensee-Specific Program Elements

A. authorized users and supervised users

B. worker-specific manufacturing process tasks

C. shipping

D. ordering and receiving radionuclides

E. applicable regulations and license conditions

F. areas where radioactive material is used or stored

G. potential hazards associated with radioactive material in each area where the individuals 

will work

H. appropriate radiation safety procedures

I. licensee’s in-house work rules (for instructions on laboratory safety and uses of 

radionuclides, see Appendix K of this NUREG)

J. each individual’s obligation to report unsafe conditions to the RSO

K. appropriate response to spills, emergencies, or other unsafe conditions

L. workers’ right to be informed of occupational radiation exposure and bioassay results, 

if applicable

M. locations where the licensee has posted or made available notices, copies of pertinent 

regulations, and copies of pertinent licenses and license conditions (including 

applications and applicable correspondence), as required by Title 10 of the Code of 

Federal Regulations (10 CFR) Part 19

N. security of materials

1. receiving materials

2. using materials

3. storing materials

4. possessing Category 1 or Category 2 materials and then 10 CFR Part 37 

security training.

O. emergency procedures

1. RSO name and telephone number

2. immediate steps to prevent or control spread of contamination

3. clean-up instructions, decontamination

P. survey program

1. radiation survey instrument accessibility

2. who is responsible
E–3

3. types, contamination, and areas

4. frequency

5. levels of contamination

6. personnel, hands, shoes

7. records

Q. radioactive waste

1. liquid

2. solids

3. sanitary sewer

4. burial (transfer to low-level waste repository)

5. storage

6. decay-in-storage

7. waste storage surveys

8. records

R. dosimetry

1. whole body

2. extremities

3. lens of eye

4. lost or replacement badges and dose assessment

5. bioassay procedures

6. records

S. Instrumentation

1. radiation survey meters—use, calibration frequency, use of check sources

2. analytical instruments—gas flow counters, liquid scintillation counters

T. Procedures for receiving packages containing radioactive materials

1. normal

2. off-duty

3. notification of user and RSO

4. security

5. exposure levels

6. possession limit

7. receipt of damaged packages

U. Procedures for opening and examining packages

1. leakage and contamination

2. monitoring packages

3. monitoring packing materials

4. gloves

5. transferring material to users
E–4

V. Animal experiments

1. description of facilities

2. procedures to be performed with animals

3. safety instructions, including handling of animals, waste, carcasses, and cleaning 

and decontamination of cages

W. Sealed sources

1. leak-test requirements

2. inventory requirements

3. exempt quantities

4. records

X. NRC/State/Licensee audit findings

Y. Other topics

Z. Question and answer period

For Laboratory Safety and Use of Radionuclides

A. Control procedures for obtaining permission to possess or possess and use radioactive 

materials at the facility; give limitations on quantity to be handled per user, or allowed 

per experiment, etc.

B. Protective clothing and what laboratory apparel to wear and what equipment to use.

C. Limitations and conditions relative to handling unsealed licensed material and what

laboratory equipment to use when working with such material. For example, discuss 

which licensed materials and what procedures should be confined to radiochemical fume 

hoods or glove boxes. Explain what shielding or remote handling equipment is to be 

used when beta or gamma-emitting licensed materials are handled.

D. Routine survey and monitoring procedures to be followed for contamination control. 

Include where and how contaminated articles and glassware are to be handled 

and stored.

E. Emergency procedures concerning spills, fires, release of material, and accidental 

contamination of personnel.

F. Decontamination procedures to use and whom to contact in case of an emergency.

G. Instructions concerning transfer of licensed materials between rooms, halls, or corridors, 

if applicable.

H. Requirements for storage, labeling of containers, and identification of areas where

licensed materials are possessed or possessed and used.

I. Personnel monitoring devices to use, where to obtain them, and exchange procedures 

and exposure results.
E–5

J. Waste disposal procedures to follow, limitations for disposal of liquid or solid wastes, and 

procedures to use for waste storage. If the program involves experiments with animals, 

procedures for cleaning animal quarters and handling animal excreta and carcasses 

for disposal.

K. Records to be maintained on possession, use, and disposal of licensed materials.

L. Prohibition of pipetting by mouth.

M. Prohibition of eating, smoking, drinking, and application of cosmetics in areas where

licensed materials are possessed or possessed and used.

APPENDIX F

FACILITIES AND EQUIPMENT

F–1

Facilities and Equipment

The applicant should consider the following list of topics that should be considered when 

developing a description of the facilities and equipment that a licensee will use or otherwise 

have available. Not every applicant will need to address each topic in its application.

• Restricted areas are defined as areas where the licensee limits access to protect 

individuals against undue risks from exposure to radiation and radioactive materials. 

The application should contain detailed descriptions and diagrams of the facilities, 

including information about the shielding properties of the construction materials used. 

Scaled drawings and sketches should be submitted showing the relationship 

between restricted and unrestricted areas and the location of all pertinent 

safety-related equipment.

• Bench-top or open work areas may be used for sealed sources, small quantities of solid 

materials in a form not likely to become airborne or dispersed, and small quantities of 

liquids of such low volatility as not to cause airborne contamination or toxicity problems. 

Trays and absorbent surface covers to catch and retain spilled liquids should be used on 

these open work surfaces and inside closed systems discussed below. Surfaces should 

be smooth and non-porous, to facilitate decontamination.

• Security zones are defined as any temporary or permanent area determined and 

established by the licensee for the physical protection of aggregated Category 1 or 

Category 2 quantities of radioactive material listed in Appendix A to Title 10 of the Code 

of Federal Regulations (10 CFR) Part 37. The security zone should be designed so that 

the licensee can monitor, detect without delay, assess, and respond to any unauthorized 

entries into security zones and any unauthorized removal of radioactive material from 

the security zone. Monitoring and detection systems may include video surveillance 

systems and electronic devices for intrusion detection alarms.

• Radioactive materials that are handled or used in unsealed forms should be confined to 

control the release of material and to prevent the spread of contamination. Gaseous, 

volatile, and fine particulate solid materials should be handled in closed or isolated

systems, such as fume hoods or glove boxes with controlled, and possibly filtered, 

exhaust systems. Ventilation systems for these facilities should be designed so that 

airborne radioactive material work areas are at negative pressure compared to 

nonradioactive work areas.

• Chemical-type fume hoods provide a working area with controlled inward airflow from 

the room to the hood exhaust system. Hoods are used for gases, unsealed volatile 

licensed materials, and processes such as evaporation that may release gases and 

vapors. Fume hoods provide emergency ventilation and exhaust for unplanned 

releases, such as accidental spills and ruptures, as well as routine exhaust of effluents. 

Filters may be required in the exhaust stream unless monitoring or calculations 

demonstrate that any planned or likely effluent will be in accordance with the limits found 

in 10 CFR Part 20, Appendix B.

• Glove boxes are sealed boxes with transparent viewing windows, sealable ports or 

doors for transferring materials and equipment, and gloves sealed to the box through 

which licensed materials are handled. Glove boxes are used for the containment during 
F–2

storage and use of liquids and solids that can become airborne particulates or aerosols. 

Glove boxes can be closed or exhausted, with filtration systems if appropriate, to 

prevent contamination.

• For the most efficient operation of hoods and glove boxes, minimize storage of materials 

and equipment inside the work areas.

• Where appropriate, ventilation systems should be designed such that, in the event of an 

accident, they can be shut down to prevent the spread of radioactivity. If appropriate, 

supply and exhaust fans can be interlocked such that if exhaust fans shut down, the 

shutdown of supply fans is also triggered, this interlock system is to prevent laboratory 

and work areas from becoming positively pressurized with respect to the surrounding 

parts of the facility.

• Sink faucets should be designed, where possible, for operation by foot, knee, or elbow 

rather than by hand.

• Plumbing and ductwork should be designed to avoid radioactive contamination build-up. 

This build-up of contamination can create external radiation exposure hazards and 

problems for decommissioning.

• To reduce radiation exposure from gamma-emitting radioactive materials, shielding 

consisting of lead or other high-density material in the form of bricks, panels, L-shields, 

storage containers, or other shapes may be used on bench tops, in fume hoods, or in 

glove boxes.

• To reduce the exposure from high-energy beta-emitting materials, shielding of 

low-atomic-number material, such as high-density plastic, may be used. In operations 

using large quantities (i.e., multi-millicurie quantities) of high-energy beta-emitting 

radionuclides or longer exposure times, it may be necessary to also reduce the 

bremsstrahlung by adding shielding containing high-atomic-number material such as 

lead. These shields generally are low-atomic-number materials closest to the source, 

enclosed by high-atomic-number material.

• Shielded shipping containers are used frequently for continued storage after receipt 

of materials.

• Remote handling tools, such as forceps or extension handles, should be used to provide 

distance in the handling of radioactive materials. In addition, shielded handling devices, 

such as shielded syringes, can be used to protect workers from materials that cannot be 

handled remotely. Pipetting should be done using appropriate devices. Pipetting by 

mouth should be strictly forbidden.

• Designated areas should be provided for coats and personal belongings, to 

avoid contamination.

• Areas with background radiation levels should be designated for personnel dosimetry 

storage when not in use.
F–3

• Areas of use should be well-lighted to avoid spills and other accidents that could result in 

contamination buildup.

• Observation of activities conducted behind shielding with remote tools (or with extended 

arms and hands, within limits consistent with permissible occupational exposures) can 

be accomplished by mirrors, through shielded (e.g., leaded glass) windows, through 

transparent plastic beta shields, or by remote video monitoring.

• The combination of containment, shielding, and handling devices proposed for any use 

of radioactive materials should be appropriate to the type and quantity of materials to be 

used and to the type and duration of operations to be conducted.

• If respiratory protective equipment will be used to limit inhalation of airborne licensed 

material, follow the provisions of 10 CFR Part 20, Subpart H, “Respiratory protection and 

controls to restrict internal exposure in restricted areas.”

• A particular sink should be designated for disposal of liquid radioactive waste to the 

sanitary sewerage system. In some cases, depending on the number of users and 

distance between areas of use, more than one sink may need to be designated.

• Labeled waste containers should be used. These containers may be shielded as 

necessary and placed near the waste-generating areas and away from areas that 

personnel frequently occupy. Additionally, these containers should be effectively 

enclosed to prevent airborne contamination from radioactive materials deposited. If 

radioactive waste materials are volatile, the containers should be stored in 

ventilated areas.

• If compaction of waste is performed, ensure that the facilities are adequate for the 

ventilation of the area where the waste is compacted. In addition, also ensure that air 

sampling for internal exposures is available, if needed per 10 CFR 20.1204.

• Adequate air and water effluent-monitoring equipment should be used to demonstrate 

compliance with the limits found in 10 CFR Part 20, Appendix B, if applicable, and tested 

for operability at the frequency established by the manufacturer.

APPENDIX G

SAMPLE AUDIT PROGRAM

G–1

Sample Audit Program

An audit is conducted, in part, to fulfill the requirements of Title 10 of the Code of Federal 

Regulations (10 CFR) 20.1101 for an annual review of the content and implementation of the 

licensee’s radiation safety program. Audits should be performance-based, and include 

observations of licensed activities, interviews with personnel, and inspection of facilities and 

equipment. Audits should also identify program weaknesses and allow licensees to take early 

corrective actions [before an U.S. Nuclear Regulatory Commission (NRC) inspection]. During 

an audit, the auditor needs to keep in mind not only the requirements of the NRC’s regulations,

but also the licensee’s commitments in its applications and other correspondence with the NRC. 

The auditor should also evaluate whether the licensee is maintaining exposures to workers and 

the general public as low as is reasonably achievable (ALARA) and, if not, make suggestions 

for improvement.

The form in this appendix can be used to document the annual audit of the radiation safety 

program. Guidance on completing each section of the form is provided below. In the “remarks” 

portions of the form, note any deficiencies identified and the corrective actions taken or to 

be taken.

Section 1 Audit History

Enter the date of the last audit, whether any deficiencies were identified, and whether actions 

were taken to correct the deficiencies.

Section 2 Organization and Scope of Program

Give a brief description of the organizational structure, noting any changes in personnel or 

procedures, and amendments to the license. Describe the scope of licensed activities at the 

audited location. Check whether the Radiation Safety Officer (RSO) is the person identified in 

the license and fulfills the duties specified in the license.

Section 3 Training, Retraining, and Instructions to Workers

Ensure that workers have received the training required by 10 CFR 19.12. Be sure that the user 

has received training and has a copy of the licensee’s safe use and emergency procedures

before being permitted to use byproduct material. Note whether refresher training is conducted,

in accordance with licensee commitments. Ensure that each worker has a copy of the 

licensee’s procedures, and, by interview or observation of selected workers, that he or she can 

implement them.

Section 4 Audits

Verify that audits fulfill the requirements of 10 CFR 20.1101, are conducted in accordance with 

licensee commitments, and are properly documented.

Section 5 Facilities

Verify that the licensee’s facilities are as described in its license documents.
G–2

Section 6 Materials

Verify that the license authorizes the quantities and types of byproduct material that the 

licensee possesses. Verify that the sealed source and devices are manufactured in accordance 

with the sealed source and device registration.

Section 7 Leak Tests

Verify that all sealed and plated foil sources are tested for leakage at the prescribed frequency 

and in accordance with licensee commitments. Records of results should be maintained.

Section 8 Inventories

Verify that inventories are conducted at least once every 6 months to account for all sources;

inventory records should be maintained.

Section 9 Radiation Surveys

Verify that the licensee has appropriate, operable, and calibrated radiation survey instruments 

available and that the instruments are calibrated (at the required frequency) in accordance with 

license conditions and in accordance with 10 CFR 20.2103. Calibration records must be 

retained for 3 years after the record is made. Check that radiation levels in areas adjacent to 

use are within regulatory limits and in accordance with 10 CFR 20.2103. Verify compliance with 

10 CFR 20.1301. Records of surveys must be retained for 3 years after the record is made.

Section 10 Receipt and Transfer of Radioactive Material (Includes Waste Disposal)

Verify that packages received from others containing byproduct material are received, opened, 

and surveyed in accordance with 10 CFR 20.1906, “Procedures for receiving and opening 

packages.” Ensure that transfers are performed in accordance with 10 CFR 30.41, 

10 CFR 40.51, and 10 CFR 70.42, as appropriate. Records of surveys, receipt, and transfer 

must be maintained in accordance with 10 CFR 20.2103 and 10 CFR 30.51, 10 CFR 40.61, and 

10 CFR 70.51, as appropriate.

Section 11 Transportation

Determine compliance with Department of Transportation (DOT) requirements. 

Section 12 Personnel Radiation Protection

Evaluate the licensee’s determination that unmonitored personnel are not likely to receive more 

than 10 percent of the allowable limits. Alternately, if personnel dosimetry is provided and 

required, verify that it complies with 10 CFR 20.1501(c) and licensee commitments. Review 

personnel monitoring records, compare exposures of individuals doing similar work, and 

determine reasons for significant differences in exposures. If any worker declared her 

pregnancy in writing, evaluate the licensee’s compliance with 10 CFR 20.1208. Check whether 

records are maintained, as required by 10 CFR 20.2101, 2102, 2103, 2104, and 2106.
G–3

Section 13 Auditor’s Independent Measurements (If Made)

The auditor should make independent survey measurements and compare the results with 

those made or used by the licensee.

Section 14 Notification and Reports

Check on the licensee’s compliance with the notification and reporting requirements in 

10 CFR Parts 19, 20, 30, 40 and 70. Ensure that the licensee is aware of the telephone number 

for NRC’s Emergency Operations Center: 301-816-5100.

Section 15 Posting and Labeling

Check for compliance with the posting and labeling requirements of 10 CFR 19.11, 20.1902, 

20.1904, and 21.6.

Section 16 Recordkeeping for Decommissioning

Check to determine compliance with 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g)

and 10 CFR 70.51(b)(3), as appropriate.

Section 17 Bulletins and Information Notices

Check to determine if all NRC correspondence (e.g., regulatory issue summaries (RISs),

bulletins, information notices, NMSS Newsletters) issued since the previous audit and 

applicable to possession licenses for manufacturing and distribution have been reviewed.

Check whether the licensee took appropriate action (e.g., training, updating procedures) in 

response to this NRC correspondence.

Section 18 Special License Conditions or Issues

Verify compliance with any special conditions on the licensee’s license. If the licensee has any 

unusual aspect of its work, review and evaluate compliance with regulatory requirements.

Section 19 Continuation of Report Items

This section is self-explanatory.

Section 20 Problems or Deficiencies Noted; Recommendations

This section is self-explanatory.

Section 21 Evaluation of Other Factors

Evaluate licensee management’s involvement with the radiation safety program, whether the 

RSO has sufficient time to perform his or her duties, and whether the licensee has sufficient 

staff to handle the workload and maintain compliance with regulatory requirements.

Note: All areas indicated in audit notes may not be applicable to every license and may not 

need to be addressed during each audit.
G–4

Sample Checklist

Audit Report No. License No. _________________________

Licensee’s name and mailing address:

 

 

 

Audit of activities at (address):

 

 

 

Contact at audit location: Telephone No.: _______________________

Date of this audit: 

Summary of Findings and Action:

[ ] No deficiencies

[ ] Deficiencies

[ ] Action on previous deficiencies

Recommendations:

Auditor: Date: 

 (Signature)
G–5

1. AUDIT HISTORY [ ] N/A (N/A means “Not applicable” – Initial Audit)

A. Last audit of this location conducted

B. Problems/deficiencies identified during last 2 audits or 2 years, 

whichever is longer [ ] Y [ ] N

C. Open problems/deficiencies from previous audits:

Status Requirement Problem/Deficiency Corrective Action 

Taken (Y/N)

Open/Closed

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

____________________________________________________________________________

D. Any previous problem/deficiency not corrected or repeated [ ] Y [ ] N [ ] N/A

Explain:

2. ORGANIZATION AND SCOPE OF PROGRAM

A. Briefly describe organizational structure

1. Structure described as in license documents [ ] Y [ ] N

2. Multiple authorized locations of use [License Condition (L/C)] [ ] Y [ ] N

3. Brief description of scope of activities involving byproduct

material, frequency of use, staff size, etc. [ ] Y [ ] N

4. Amendments and program changes (L/C) [ ] Y [ ] N

B. Radiation Safety Officer [ ] Y [ ] N

1. Authorized on license (L/C) [ ] Y [ ] N

2. Fulfills duties as RSO [ ] Y [ ] N

C. Radioactive material used only by authorized individuals (L/C) [ ] Y [ ] N

D. Commensurate security program implemented

(10 CFR 20.1801, 20.1802 and Part 37 if applicable) [ ] Y [ ] N
G–6

Remarks:

3. TRAINING, RETRAINING, AND INSTRUCTIONS TO WORKERS

A. Instructions to workers in accordance with (10 CFR 19.12) [ ] Y [ ] N

B. Training program required [ ] Y [ ] N

C. Training records maintained [ ] Y [ ] N

D. Evaluation of individuals’ understanding of procedures and

regulations based on interviews and observations of 

selected workers [ ] Y [ ] N

1. Each has an up-to-date copy of the licensee’s safe use and

emergency procedures

2. Adequate understanding of the following:

• Current safe use procedures [ ] Y [ ] N

• Emergency procedures [ ] Y [ ] N

E. 10 CFR Part 20

Workers cognizant of requirements for the following:

1. Radiation Safety Program (10 CFR 20.1101) [ ] Y [ ] N

2. Annual dose limits (10 CFR 20.1301,

10 CFR 20.1302, and 10 CFR 20.1207) [ ] Y [ ] N

3. NRC Forms 4 and 5 [ ] Y [ ] N

4. Ten percent monitoring threshold (10 CFR 20.1502) [ ] Y [ ] N

5. Dose limits to embryo/fetus and declared pregnant

women (10 CFR 20.1208) [ ] Y [ ] N

6. Procedures for opening packages (10 CFR 20.1906) [ ] Y [ ] N

Remarks:

4. INTERNAL AUDITS, REVIEWS, OR INSPECTIONS

A. Audits are conducted. [ ] Y [ ] N

1. Audits conducted by__________________________________________________

2. Frequency__________________________________________________________
G–7

B. Content and implementation of the radiation protection

program reviewed at least annually [10 CFR 20.1101(c)]. [ ] Y [ ] N

C. For programs possessing Category 1 or Category 2 materials:

1. Access program content and implementation

[10 CFR 37.33(a)] [ ] Y [ ] N [ ] N/A

2. Security program review

(10 CFR 37.55) [ ] Y [ ] N [ ] N/A

D. Records are maintained (10 CFR 20.2102). [ ] Y [ ] N

5. FACILITIES

A. Facilities are described as in the license application (L/C). [ ] Y [ ] N

B. Security procedures implemented 

(20.1801, 20.1802; Part 37, if applicable) [ ] Y [ ] N

Remarks:

6. MATERIALS

Isotopes, quantities, and use are as authorized on license (L/C). [ ] Y [ ] N

For each SSD registration:

SSD application documents maintained [ ] Y [ ] N

Sealed source and devices model numbers being distributed

currently on the SSD certificate [ ] Y [ ] N

Changes to registered devices/sealed source has been

submitted to the NRC or Agreement State and approved [ ] Y [ ] N

The appropriate QA/QC checks are being performed as required

by SSD registration application/references [ ] Y [ ] N

The products are being distributed for an active registration [ ] Y [ ] N

Inactivation request was submitted to the NRC or Agreement State 

for product no longer manufactured or distributed in accordance 

with 10 CFR 32.211 [ ] Y [ ] N

Remarks:
G–8

7. LEAK TESTS

A. Leak test is performed as described in correspondence

with the NRC (consultant, leak test kit, and

licensee performed) (L/C). [ ] Y [ ] N

B. Frequency of tests is every 6 months or another interval,

as approved by the NRC or Agreement State (L/C). [ ] Y [ ] N

C. Records with appropriate information are maintained (L/C). [ ] Y [ ] N

Remarks:

8. INVENTORIES

A. Inventories are conducted at 6-month intervals (L/C). [ ] Y [ ] N

B. Records with appropriate information are maintained (L/C). [ ] Y [ ] N

Remarks:

9. RADIATION SURVEYS

A. Instruments and equipment: [ ] Y [ ] N

1. Appropriate operable radiation survey instrumentation

is possessed or is readily available. [ ] Y [ ] N

2. Instruments and equipment are calibrated

as required (10 CFR 20.1501). [ ] Y [ ] N

3. Calibration records are maintained [10 CFR 20.2103(a)]. [ ] Y [ ] N

B. Briefly describe survey requirements [10 CFR 20.1501(a)]:

C. Surveys are performed as required [10 CFR 20.1501(a)]. [ ] Y [ ] N

1. Radiation levels are within regulatory limits. [ ] Y [ ] N

2. Corrective action was taken and documented. [ ] Y [ ] N

D. Records are maintained (10 CFR 20.2103). [ ] Y [ ] N

E. Protection of members of the public:

1. Adequate surveys are made to demonstrate that 

(i) the TEDE to the individual who is likely to receive the 

highest dose does not exceed 100 mrem in a year or 

(ii) that if an individual were continuously present in an 

unrestricted area, the external dose would not exceed

2 mrem in any hour and 50 mrem in a year

[10 CFR 20.1301(a)(1) and 10 CFR 20.1302(b)]. [ ] Y [ ] N
G–9

2. Unrestricted area radiation levels do not exceed 2 mrem

in any 1 hour [10 CFR 20.1301(a)(2)]. [ ] Y [ ] N

3. Records are maintained (10 CFR 20.2103 and

10 CFR 20.2107). [ ] Y [ ] N

Remarks:

10. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL 

(INCLUDES WASTE DISPOSAL)

A. Procedures describe how packages are

received and by whom. [ ] Y [ ] N

B. Written package opening procedures are established and

are followed [10 CFR 20.1906(e)]. [ ] Y [ ] N

C. If a package shows evidence of degradation, it is

monitored for contamination and radiation levels. [ ] Y [ ] N [ ] N/A

D. Monitoring of degraded packages is performed within time

specified [10 CFR 20.1906(c)]. [ ] Y [ ] N [ ] N/A

E. A transfer(s) between licensees (including “disposal”) is

performed in accordance with (10 CFR 30.41, 40.51, 70.42). [ ] Y [ ] N [ ] N/A

F. Records of receipt/transfer are maintained

[10 CFR 20.2103(a) and 10 CFR 30.51, 40.61, 70.51]. [ ] Y [ ] N

G. Transfers within licensee’s authorized users or locations

are performed as required [license condition (L/C)]. [ ] Y [ ] N [ ] N/A

H. Package receipt/distribution activities are evaluated for

compliance with (10 CFR 20.1301 and 10 CFR 20.1302). [ ] Y [ ] N [ ] N/A

I. Reports of transactions involving nationally tracked sources

are submitted as required (10 CFR 20.2207). [ ] Y [ ] N [ ] N/A

Remarks:

11. TRANSPORTATION [10 CFR 71.5(a) and 49 CFR 170-180] [ ] Y [ ] N [ ] N/A

A. Licensee shipments are as follows:

1. Shipments were delivered to common carriers. [ ] Y [ ] N [ ] N/A

2. Shipments were transported in licensee’s own

private vehicle. [ ] Y [ ] N [ ] N/A

3. No shipments were made since last audit. [ ] Y [ ] N [ ] N/A
G–10

B. Hazmat Training

1. Applicability and responsibility for training and

testing (49 CFR 172.702). [ ] Y [ ] N [ ] N/A

2. Training requirements (49 CFR 172.704). [ ] Y [ ] N [ ] N/A

C. Packages [ ] N/A

1. Authorized packages were used 

[49 CFR 173.415, 173.416(b)]. [ ] Y [ ] N [ ] N/A

2. Packages were closed and sealed during transport

[49 CFR 173.475(f)]. [ ] Y [ ] N

D. Shipping Papers [ ] N/A

1. Shipping papers were prepared and used

[49 CFR 172.200(a)]. [ ] Y [ ] N

2. Papers included proper shipping name, hazard class,

UN number, quantity, package type, radionuclide, 

reportable quantities, radioactive material, physical

and chemical form, activity, category of the label,

TI (Transport Index), shipper’s name, certification and 

signature, emergency response phone number, and “Cargo 

Aircraft Only” (if applicable) (49 CFR 172.200 through 

49 CFR 172.204). [ ] Y [ ] N

3. Papers were readily accessible during transport

[49 CFR 177.718(e)]. [ ] Y [ ] N

E. Vehicles [ ] Y [ ] N

1. The cargo was blocked and braced 

[49 CFR 177.842(d)]. [ ] Y [ ] N

2. Placarded, if needed (49 CFR 172.504). [ ] Y [ ] N

3. Proper overpacks, if used (with shipping name,

UN number, cargo labeled, and statement that 

indicates that the inner package complies

with the specification package) (49 CFR 173.25). [ ] Y [ ] N

F. Any incidents reported to DOT (49 CFR 171.15 and 

49 CFR 171.16). [ ] Y [ ] N

G. Physical protection of Category 1 or Category 2 quantity

of radioactive material in transit (10 CFR Part 37, Subpart D). [ ] Y [ ] N [ ] N/A
G–11

Remarks:

12. PERSONNEL RADIATION PROTECTION

A. ALARA considerations are incorporated into the Radiation

Protection Program [10 CFR 20.1101(b)]. [ ] Y [ ] N

B. Evaluations are performed showing that unmonitored 

individuals receive less than the limits in 10 CFR 20.1502(a). 

The evaluations consider doses to minors 

[10 CFR 20.1502(a)(2)] and declared pregnant women 

[10 CFR 20.1502(a)(3)]. [ ] Y [ ] N [ ] N/A

C. Unmonitored individuals’ activities changed during the 

year in a way that could put them over the limits in 

10 CFR 20.1502(a). [ ] Y [ ] N [ ] N/A

If yes, new evaluation was performed. [ ] Y [ ] N [ ] N/A

D. External dosimetry is required [i.e., when individuals are 

likely to receive greater than the limits in 10 CFR 20.1502(a)], 

and provided to individuals. [ ] Y [ ] N

If yes, address the following:

1. The dosimetry supplier is approved by the National 

Voluntary Laboratory Accreditation Program

[10 CFR 20.1501(c)]. [ ] Y [ ] N [ ] N/A

2. Dosimeters are exchanged at the appropriate frequency. [ ] Y [ ] N [ ] N/A

3. Dosimetry reports are reviewed and signed by the RSO 

when they are received. [ ] Y [ ] N [ ] N/A

4. Records are based on NRC forms or the equivalent 

[10 CFR 20.2104(d) and 20.2106(c)]. [ ] Y [ ] N [ ] N/A

a. NRC Form 4, “Cumulative Occupational Exposure 

History,” are complete. [ ] Y [ ] N [ ] N/A

b. NRC Form 5, “Occupational Dose Record for a 

Monitoring Period,” are complete. [ ] Y [ ] N [ ] N/A

E. Declared pregnant workers in the workforce. [ ] Y [ ] N

1. Dose equivalent to an embryo/fetus complied with 

10 CFR 20.1208. [ ] Y [ ] N [ ] N/A

2. Records of doses to an embryo/fetus complied with

10 CFR 20.2106(e). [ ] Y [ ] N [ ] N/A
G–12

F. Records of exposures, surveys, monitoring, and evaluations 

maintained (10 CFR 20.2102, “Records of radiation protection 

programs;” 10 CFR 20.2103, “Records of surveys;”

10 CFR 20.2106, “Records of individual monitoring results”). [ ] Y [ ] N [ ] N/A

Remarks:

13. AUDITOR’S INDEPENDENT MEASUREMENTS (IF MADE)

A. Radiation survey instrument: Serial No.: Last calibration:

B. The auditor’s measurements were compared to the licensee’s [ ] Y [ ] N [ ] N/A

measurements.

C. Describe the type, location, and results of the measurements:

14. NOTIFICATION AND REPORTS

A. The licensee is in compliance with 10 CFR 19.13 (reports to [ ] Y [ ] N [ ] N/A

individuals, public, and occupational, monitored to show

compliance with 10 CFR Part 20).

B. The licensee is in compliance with 10 CFR 20.2201 [ ] Y [ ] N [ ] N/A

(theft or loss).

C. The licensee is in compliance with 10 CFR 20.2202 and

10 CFR 30.50, 40.60, 70.50 (incidents). [ ] Y [ ] N [ ] N/A

D. The licensee is in compliance with 10 CFR 20.2203 and

10 CFR 30.50, 40.60, 70.50 (overexposures and

high radiation levels). [ ] Y [ ] N [ ] N/A

E. The licensee is aware of the telephone number for the

NRC Emergency Operations Center (301-816-5100). [ ] Y [ ] N

F. Reporting of events (10 CFR 37.57) [ ] Y [ ] N [ ] N/A

15. POSTING AND LABELING

A. NRC Form 3, “Notice to Workers,” is posted (10 CFR 19.11). [ ] Y [ ] N

B. 10 CFR 19, 20, 21; Section 206 of the Energy

Reorganization Act of 1974; procedures adopted pursuant 

to Part 21; and license documents are posted, or a notice 

indicating the documents can be examined is posted 

(10 CFR 19.11 and 10 CFR 21.6). [ ] Y [ ] N

C. Other posting and labeling activities, in accordance with

10 CFR 20.1902 and 10 CFR 1904, and the license are

not exempted by 10 CFR 20.1903 and 10 CFR 1905. [ ] Y [ ] N
G–13

Remarks:

16. RECORD KEEPING FOR DECOMMISSIONING (IF NEEDED) [ ] N/A

A. Records of information important to the safe and effective

decommissioning of the facility are maintained in an

independent and identifiable location until license 

termination. [ ] Y [ ] N

B. Records include all information outlined in 10 CFR 30.35(g),

40.36(f), 70.25(g) and 70.51(b)(3). [ ] Y [ ] N

Remarks:

17. BULLETINS AND INFORMATION NOTICES

A. NRC Correspondence (e.g., RISs, bulletins,

information notices, NMSS newsletters, etc.) issued since

last audit have been reviewed. [ ] Y [ ] N

B. Appropriate action was taken in response to bulletins,

information notices, and other communications. [ ] Y [ ] N

Remarks:

18. SPECIAL LICENSE CONDITIONS OR ISSUES [ ] N/A

A. Review special license conditions or other issues and 

describe findings (L/C):

B. Problems/deficiencies identified at the licensee’s facilities

other than at audit location (L/C):

C. Evaluation of compliance (L/C):

19. CONTINUATION OF REPORT ITEMS [ ] N/A

(If more space is needed, use separate sheets and attach them to the report.)

20. PROBLEMS OR DEFICIENCIES NOTED—RECOMMENDATIONS [ ] N/A

A. Briefly state the requirement and explain how and when it was violated.

B. Provide recommendations for improvement.

21. EVALUATION OF OTHER FACTORS

A. Senior licensee management is appropriately involved with the

radiation safety program and/or RSO oversight [ ] Y [ ] N
G–14

B. The RSO has sufficient time to perform his/her radiation

safety duties and is not too busy with other assignments. [ ] Y [ ] N

C. The licensee has sufficient staff. [ ] Y [ ] N

Remarks/recommendations:
APPENDIX H

RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND MODEL 

RADIATION SURVEY INSTRUMENT CALIBRATION PROGRAM

H–1

Radiation Monitoring Instrument Specifications and Model 

Radiation Survey Instrument Calibration Program

Radiation Monitoring Instrument Specifications

Licensees should possess and use calibrated and operable radiation detection and 

measurement instruments that are sufficiently sensitive to detect and measure the type and

energy of the radiation used. Applicants should determine the number and type of instruments 

necessary to support licensed activities by considering the scope of activities that will be 

performed at their facilities. Licensees typically possess one or more portable or handheld 

instruments to monitor radiological conditions, detect contamination, and perform 

package-preparation and receipt surveys. Portable instrumentation includes ionization 

chambers as well as other instrumentation, such as count-rate meters that are supported by a 

variety of handheld probes or detectors that can be used to detect various types of radiation. 

These include Geiger-Mueller (GM) detectors, sodium iodide [NaI(Tl)] scintillation detectors, 

and plastic scintillation detectors. Additionally, licensees may possess stationary or fixed 

instrumentation, such as well-type scintillation counters, area monitors, stack monitors, or 

continuous air monitors. 

When deciding which types of instruments are appropriate for the intended use, licensees may 

wish to consult with the instrumentation or equipment manufacturer or vendor to obtain 

specifications. The instrument should be capable of detecting the type of radiation (e.g., alpha, 

beta, gamma) and be sensitive to the energy or energy range of the radiation to be measured 

(e.g., keV, MeV). The characteristics of the instrument, including principles of operation and 

expected efficiency for the type and energy of the radiation being measured, should be 

understood by the licensee prior to use. 

Applicants may wish to consider the following instrument selection guidelines: 

• Alpha emitters and low-energy beta emitters, such as carbon-14 and sulfur-35, may be 

detected with thin windowed proportional counters. The proper surveying method 

(e.g., speed and height above surface) is important to perform adequate surveys. 

Additionally, wipes should be taken and counted with a liquid scintillation counter to 

verify potential removable contamination.

• Medium- to high-energy beta emitters, such as phosphorus-32 and calcium-45, can be 

detected with a pancake GM. The efficiency ranges from 15 percent to 40 percent, 

depending on the beta energy.

• Low-energy gamma emitters, such as iodine-125, can be detected with a sodium iodide 

(Nal) probe or a thin window GM probe (pancake or thin end-window). If the sodium 

iodide probe possesses a thin window and thin crystal, the detection efficiency is 

approximately 20 percent. If a pancake or thin end-window GM probe is used, the 

detection efficiency is significantly lower, and care should be taken to ensure that the 

GM probe is capable of detecting any established action levels.

• Medium- to high-energy gamma emitters, such as iodine-131 or high-energy photon 

emitters, such as fluorine-18, can be detected with either GM or sodium iodide probes, 

depending on the required sensitivity. In general, the sensitivity of GM probes is much 

lower than for sodium iodide probes.
H–2

• Neutron emitters, such as a neutron generator, californium 252, or beryllium ring on a 

high specific-activity alpha source such as americium 241, can be detected by tissue 

equivalent proportional counters or helium-3 proportional counters.

Further guidance regarding instrumentation can be found in Chapter 9 of the Handbook 

of Health Physics and Radiological Health, Fourth Edition, Edited by Thomas E. Johnson and 

Brian Kent Birky, 2012.

Model Radiation Survey Instrument Calibration Program

Training

Before independently calibrating radiation survey instruments, an individual should complete 

both classroom and on-the-job training as follows:

• Classroom training may be in the form of lecture, video, computer-based, or self-study 

and will cover the following subject areas:

— principles and practices of radiation protection

— radioactivity measurements, monitoring techniques, and the use of radiation 

detection instruments

— mathematics related to the use and measurement of radioactivity

— biological effects of radiation

• On-the-job training will consist of the following:

— observing authorized personnel performing radiation-surveyinstrument calibration

— conducting radiation survey meter calibrations under the supervision and in the 

physical presence of an individual already authorized to perform calibrations

Facilities and Equipment for Calibration of Dose and Dose Rate Measuring Instruments

To reduce doses received by individuals not calibrating radiation survey instruments, 

calibrations will be conducted in an isolated area of the facility or at times when no one else 

is present.

The calibration source should be well-collimated, and the calibration area should be designed to 

minimize scatter of radiation, which could affect the calibration process.

The calibration area should be appropriately controlled so that persons entering the area will be 

aware if a radiation source is in use.

Evaluate posting of the calibration area with appropriate radiation warning signs, as required by 

Subpart J of Title 10 of the Code of Federal Regulations (10 CFR) Part 20.

Individuals conducting calibrations of radiation survey instruments will wear assigned dosimetry.
H–3

Individuals conducting calibrations will use a calibrated and operable radiation survey 

instrument to ensure that unexpected changes in exposure rates are identified and corrected.

Frequency of Calibration of Radiation Measurement Instruments and Equipment

A licensee committed to a routine or emergency radiation survey program should perform an 

acceptable calibration of all radiation measurement instruments and equipment at the frequency 

specified in U.S. Nuclear Regulatory Commission (NRC) regulations, annually, or at the 

frequency recommended by the manufacturer, whichever period is shorter.

Special calibrations should be performed at any time there is reason to believe that the 

operating characteristics of a radiation measurement instrument have changed, by repair or 

alteration, or whenever system performance is observed to change significantly.

Routine maintenance of radiation measurement instruments should be performed as 

recommended by the manufacturer.

Primary or secondary standard instruments used to calibrate radiation measurement

instruments should be inspected frequently for consistency of performance.

Calibration Sources for Dose and Dose Rate Measuring Instruments

Radioactive sealed sources will be used for calibrating dose and dose rate measuring radiation 

survey instruments; these sources will have the following characteristics:

• The sources should approximate a point source.

• Calibration fields from gamma sources should be known with an accuracy when 

compared to secondary or primary national standards of 5 percent for dose rates greater 

than or equal to 1.0 μGy/h [0.1 mrad/h] and 10 percent for dose rates less than 

1.0 μGy/h [0.1 mrad/h].

• The sources should contain a radionuclide that emits radiation of identical or similar type 

and energy as the environment in which the calibrated device will be used.

• The sources should be strong enough to give an exposure rate of at least 

7.7 microcoulomb per kilogram per hour [30 milliroentgen per hour] at 100 centimeters 

{e.g., 3.1 gigabecquerels [85 millicuries] of cesium-137 or 780 megabecquerels 

[21 millicuries] of cobalt-60}.

Note: Inverse square and radioactive decay laws should be used to correct changes in 

exposure rate due to changes in distance or source decay.

Calibration of Dose or Dose Rate Measuring Instruments

There are three kinds of scales frequently used on dose and dose-rate survey meters. These 

are calibrated as follows:

• Linear readout instruments with a single calibration control for all scales should be 

adjusted at the point recommended by the manufacturer or at a point within the normal 

range of use. Instruments with calibration controls for each scale should be adjusted on 
H–4

each scale. After adjustment, check the response of the instrument at approximately 

20 percent and 80 percent of full scale. Instrument readings should be within ± x

(noted below) of the conventionally true value for the following ranges:

— Background to 10 μGy/h [1.0 mrad/h]; ±x = ±30%

— 10 μGy/h [1.0 mrad/h] to 1.0 mGy/h [100 mrad/h]; ±x = ±20%

— 1.0 mGy/h [100 mrad/h] to 10 Gy/h [1,000 Rad/h]; ±x = ±10%

• Logarithmic readout instruments, which commonly have a single readout scale 

spanning several decades, normally have two or more adjustments. Adjust the 

instrument for each scale according to site specifications or the manufacturer’s 

specifications. After adjustment, check the calibration at a minimum of one point on 

each decade. Instrument readings should have a maximum deviation from the 

conventionally true value as described for linear readout instruments.

• Digital readout instruments should be calibrated the same as linear 

readout instruments.

Note: Readings above 2.58 × 10−4 coulomb/kilogram/hour [1 roentgen (R)/h] need not be 

calibrated, unless the licensee expects to make measurements at higher dose rates; regardless, 

such scales should be checked for operation and response to radiation.

Note: Instruments used to monitor higher energies are most easily calibrated in known 

radiation fields produced by sources of gamma rays of approximately the same energies as 

those to be measured.

Calibration of Surface Contamination Measurement Instruments

Instruments used to detect surface contamination usually consist of a count-rate meter and a 

detector that is appropriate for the types of radiation being measured.

The efficiency of radiation survey meters must be determined by using radiation sources with 

similar energies and types of radiation that users of the radiation survey instrument intend 

to measure. 

If each scale has a calibration potentiometer, the reading should be adjusted to respond to the 

calibration source at approximately 80 percent of full scale, and the response at approximately 

20 percent of full scale should be observed. If only one calibration potentiometer is available, 

the response should be adjusted at mid-scale on one of the scales and response on the other 

scales should be observed. The instrument efficiency factor (e.g., cpm/dpm) thus obtained 

should have a signal-to-noise ratio, including the compilation of source and instrument 

uncertainties, of ±x for the following ranges: 

• alpha measurement

— 0.01 Bq/cm2 to 2.0 Bq/cm2 [60 to 12,000 dpm/100 cm2

]; ±x = ±20%

— 2.0 Bq/cm2 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2

]; ±x = ±10%
H–5

• beta measurement

— 0.05 Bq/cm2 to 2.0 Bq/cm2 [300 to 12,000 dpm/100 cm2

]; ±x = ±20%

— 2.0 Bq/cm2 to 200 Bq/cm2 [12,000 to 1,200,000 dpm/100 cm2

]; ±x = ±10%

Calibration of Analytical Instruments Such As Liquid Scintillation Counters, Gamma 

Counters, Gas Flow Proportional Counters, and Multichannel Analyzers

Analytical instruments used to determine radioactivity in a sample may be specialized 

equipment according to the type of samples to be analyzed and the types and quantities of 

radioactivity to be measured. Typically, the sample sizes and activities are very small, and can 

be difficult to measure. Sample collection and preparation may differ for the various analytical 

instruments, so manufacturer procedures and industry standard practices should be followed. 

Such analytical instruments should be calibrated in accordance with the manufacturer’s 

instructions. Analytical instruments typically require routine maintenance and verification 

procedures to ensure that they are operating properly when used.

As with calibration of other radiation measurement instruments, calibration of analytical 

instruments use radioactive sealed sources. These should be suitable for the geometry of the 

samples to be analyzed. The calibration sources should have a known activity and be of similar 

type and energy as the radioactive materials to be analyzed. The analysis should be sensitive 

enough to detect the lowest levels of radioactivity desired. Correction of results for quenching, 

self-absorption, and other factors may be required, depending on the analytical instrument, the 

samples type, and other environmental conditions. 

Calibration Records

Calibration records for all radiation survey instruments should indicate the procedure used and 

the results of the calibration. The records should include the following:

• the owner or user of the radiation survey instrument

• a description of the radiation survey instrument that includes the manufacturer’s name, 

model number, serial number, and type of detector

• a description of the calibration source, including the exposure rate at a specified 

distance or activity on a specified date

• for each calibration point, the calculated exposure rate or count rate, the indicated 

exposure rate or count rate, the deduced correction factor (the calculated exposure rate 

or count rate divided by the indicated exposure rate or count rate), and the scale 

selected on the radiation survey instrument 

• the exposure reading indicated with the radiation survey instrument in the “battery 

check” mode (if available on the instrument)

• for radiation survey instruments with external detectors, the angle between the radiation 

flux field and the detector (i.e., parallel or perpendicular)

• for radiation survey instruments with internal detectors, the angle between the radiation 

flux field and a specified surface of the instrument
H–6

• for radiation detectors with removable shielding, an indication of whether the shielding 

was in place or removed during the calibration procedure

• the exposure rate or count rate from a check source, if used

• the name and signature of the individual who performed the calibration and the date on 

which the calibration was performed

The following information will be attached to the radiation survey instrument as a calibration 

sticker or tag:

• for dose and dose rate measuring instruments, the source radionuclide used to calibrate 

the radiation survey instrument (with correction factors) for each scale

• for surface contamination measurement instruments, the efficiency of the radiation 

survey instrument for each radionuclide the instrument will be used to measure 

(if efficiency is not calculated before each use)

• for each scale or decade not calibrated, an indication that the scale or decade was 

checked only for function but not calibrated

• the date of calibration and the next calibration due date

• the apparent exposure rate or count rate from the check source, if used

Air Sampler Calibration

To assess accurately the air concentration of radioactive materials in a given location, the 

volume of air sampled and the quantity of contaminant in the sample must be determined. 

Accurate determination of the volume of air sampled requires standard, reproducible, and 

periodic calibration of the air metering devices that are used with air sampling instruments.

Licensees can find guidance on total air sample volume calibration methods acceptable to NRC 

staff in the publication titled “Air Sampling Instruments,” which can be found in the 9th Edition, 

American Conference of Governmental Industrial Hygienists, 2001. This information is 

supplemented below.

Frequency of Calibration of Air Sampling Equipment

• A licensee committed to a routine or emergency air sampling program should perform an 

acceptable calibration of all airflow or volume metering devices at least annually 

(see Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace”).

• Special calibrations should be performed at any time there is reason to believe that the 

operating characteristics of a metering device have been changed, by repair or 

alteration, or whenever system performance is observed to have changed significantly.

• Routine instrument maintenance should be performed as recommended by 

the manufacturer.
H–7

• Primary or secondary standard instruments used to calibrate air sampling instruments 

should be inspected frequently for consistency of performance.

Error Limit for Measurement of Air Sample Volume

Most methods of calibrating airflow or air volume metering devices require direct comparison to 

a primary or secondary standard instrument to determine a calibration curve or a correction 

factor. An example of a primary standard is a spirometer that measures total air volume directly 

with high precision by liquid displacement. An example of a secondary standard is a wet-test 

meter that has been calibrated against a primary standard.

The following are significant errors associated with determining the total air volume sampled:

EC: The error in determining the calibration factor. (An acceptable estimate is the 

percentage error associated with the standard instrument used in the calibration.)1

ES: Intrinsic error in reading the meter scale. (An acceptable estimate is the percentage 

equivalent of one-half of the smallest scale division, compared to the scale reading.)

Et: The percentage error in measurement of sampling time that should be kept within 

1 percent.

EV: The most probable value of the cumulative percentage error in the determination of the 

total air volume sampled. EV can be calculated from the following equation, provided 

there are no additional significant sources of errors:

EV = [ES

2 + EC2 + Et2

]

1/2

The most probable value of the cumulative error EV, in the determination of total volume, should 

be less than 20%.

A sample calculation of the most probable value of the cumulative error in total volume 

measured is as follows: If accuracies of the scale reading, the calibration factor, and sample 

time are ± 4, 2, and 1%, respectively, and there are no other significant sources of error, the 

cumulative error would be:

EV = [42 + 22 + 12

]

1/2 = 4.58% or approx. 5%

 

1The calibration factor should be based on two kinds of determinations. First, correction factors should be 

determined at several flow rates distributed over the full-scale range. Each flow rate correction factor should be 

determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets of 

data should be compared. Second, subsequent calibrations should compare the new correction factors to those 

determined during the previous calibration. If observed differences are significant compared to the overall volume 

error limit of 20 percent, licensees should include an additional error term in the calculation above.
H–8

If there are significant differences in pressure and temperature between the calibration site 

and the sampling site, appropriate corrections should be made using the ideal gas laws 

provided below:

Vs = V1 * (P1/760) * (273/T1)

where: Vs = volume at standard pressure and temperature (760 mm Hg and 273̊K)

V1 = volume measured at conditions P1 and T1

T1 = temperature of V1 in K

P1 = pressure of V1 in mm Hg

Documentation of Calibration of Air Metering Devices

The licensee should maintain records of all routine and special calibrations of airflow or volume 

metering devices, including the primary or secondary standard used, method employed, and 

estimates of accuracy of the calibrated metering devices. All instruments should be clearly 

labeled as to the date and results of the most recent calibration and should include the 

appropriate correction factors to be used.

References: 

• Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” June 1992.

• NUREG–1400, “Air Sampling in the Workplace,” September 1993 

(available at the ADAMS Accession No. ML13051A671)

• Health Physics and Radiological Health, 4th Edition. Edited by Thomas E. Johnson and 

Brian Kent Birky, 2012.

• American National Standards Institute (ANSI) N323AB-2013, “American National 

Standard for Radiation Protection Instrumentation Test and Calibration, Portable Survey 

Instruments.”

• “Air Sampling Instruments,” American Conference of Governmental Industrial Hygienists, 

9th Edition, 2001.
APPENDIX I

MATERIAL RECEIPT AND ACCOUNTABILITY

I–1

Material Receipt and Accountability

The licensee can possess only the radionuclides in the types and forms listed on the license, 

and the total quantity possessed under the license must not exceed the maximum possession 

limit listed on the license. Therefore, the Radiation Safety Officer (RSO) should know how 

much material is possessed under the license, in all locations, at any time. The licensed 

inventory includes all radioactive materials in use, in storage, and in waste. The regulations in 

Title 10 of the Code of Federal Regulations (10 CFR) 30.51, 40.61, 70.51 and 

10 CFR Part 74 require the licensee to maintain records of receipt, transfer, and disposal of all 

licensed materials. 

Sample Procedure for Ordering and Receiving Radioactive Material

• The RSO should approve or place all orders for radioactive material and should ensure 

that the requested material, quantities, (and for sealed sources and devices, the 

manufacturer and model of the source or device) are authorized by the license and that 

the possession limits are not exceeded.

• During normal working hours, carriers should be instructed to deliver radioactive 

packages directly to the RSO (or designated receiving area).

• During off-duty hours, security or other designated trained personnel should accept 

delivery of radioactive packages, in accordance with the procedure outlined in the 

sample memorandum below:

• If a Category 1 or Category 2 sealed source listed in Appendix E to 10 CFR Part 20 

(i.e., a “nationally tracked source,” as defined in 10 CFR 20.1003) is received, it must 

Sample Memorandum 

Memorandum for Security Personnel

From: RSO, President, Vice President, etc.

Subject: Procedures for Receipt of Packages Containing Radioactive Material

If the package appears to be damaged, immediately contact the RSO. Ask the carrier to remain 

at the facility until it can be determined that neither the carrier nor the vehicle is contaminated.

Any packages containing radioactive material that arrive between certain hours (state times, 

e.g., 4:30 p.m. and 7:00 a.m. or on Saturdays or Sundays) must be signed for by the security 

guard (or other designated trained individual) on duty and taken immediately to the designated 

receiving area. Security personnel (or other designated trained individual) should unlock the 

door, place the package in the designated secured storage area, and re-lock the door.

Radiation Safety Officer (RSO): 

Office Phone: 

Home Phone: 
I–2

be tracked in the National Source Tracking System (NSTS) in accordance with 

10 CFR 20.2207. The regulations in 10 CFR 20.2207 require that each licensee that 

manufactures, transfers, receives, disassembles, or disposes of a nationally tracked 

source shall complete and submit a National Source Tracking Transaction Report 

(NSTTR) to the U.S. Nuclear Regulatory Commission (NRC). The NSTTRs are 

maintained in the NSTS, a secure computer system that tracks Category 1 and 

Category 2 nationally tracked sources from the time they are manufactured or imported 

through the time of their disposal or export, or until the source activity decays to below 

Category 2.

Sample Instructions to Personnel Involved in Material Receipt

Shipping and Receiving Personnel

During normal working hours, immediately upon receipt of any package of licensed material, 

each package must be visually inspected for any signs of shipping damage, such as crushed 

or punctured containers or signs of dampness. Any obvious damage must be reported to the 

RSO immediately. Do not touch any package suspected of leaking. Request the person 

delivering a damaged package to the facility remain at the facility until they are monitored by 

the RSO.

Outside of normal working hours (e.g., nights, weekends, and holidays), deliveries usually will 

be handled by security personnel (or other trained individuals), as described in the above 

procedures. Because certain packages of licensed material will have detectable external 

radiation, they should be sent immediately to a designated storage area, where they will be 

checked for contamination and external radiation level as soon as practical. Packages should 

not be allowed to remain in the receiving area any longer than necessary, as they may be a 

source of exposure for receiving personnel.

If the instructions are not clear, or if there are questions regarding receiving packages 

containing radioactive material, please contact:

Name 

Phone 

For additional information on worker training, see the section titled, “Training for Individuals 

Working In or Frequenting Restricted Areas.”

Sample Procedure for Safely Opening Packages Containing Licensed Materials

For packages received under the specific license, authorized individuals must implement 

procedures for opening each package, as follows:

• Wear gloves to prevent hand contamination.

• Visually inspect the package for any sign of damage (e.g., crushed, punctured). If 

damage is noted, stop and notify the RSO.

• Monitor the external surfaces of a labeled package according to specifications in 

Table 8-2 of Section 8.10.3.
I–3

• Check Department of Transportation White I, Yellow II, or Yellow III label or packing slip 

for activity of contents, to ensure that the shipment meets the activity as requested by 

the order and does not exceed license possession limits.

• Open the outer package (following supplier’s directions, if provided) and remove packing 

slip. Open inner package to verify contents (compare requisition, packing slip, and 

label on the bottle or other container). Check integrity of the final source container 

(e.g., inspecting for breakage of seals or vials, loss of liquid, discoloration of packaging 

material, high count rate on smear). If anything is found other than what was expected, 

stop and notify the RSO.

• Survey the packing material and packages for contamination before discarding. If 

contamination is found, treat as radioactive waste. If no contamination is found, 

obliterate the radiation labels prior to discarding in the regular trash.

• Maintain records of receipt, package survey, and wipe test results.

• Notify the final delivery carrier and the NRC Operations Center, 301-816-5100, by 

telephone when removable radioactive surface contamination exceeds the limits of 

10 CFR 71.87(i) or the external radiation levels exceed the limits of 10 CFR 71.47,

External radiation standards for all packages.”

Sample Procedure for Accountability for Unsealed Materials

• The RSO should maintain an accountability log (inventory) of all radioactive materials 

possessed under the license that demonstrates that the license limits are not exceeded,

that all materials received are accounted for, and that material is disposed of or 

transferred prior to being removed from the current inventory. 

• For each radionuclide listed on the license, the RSO should maintain a record of each 

shipment of material received under the license and indicate the total amount possessed 

from all shipments. 

• Each authorized user (AU) who receives material should maintain a log showing the 

receipt of each vial and the use and disposal of the material. Material may be tracked by 

vial, by order, or in some other unit that can be “counted.”

• Each AU should maintain records of the locations and quantities of licensed materials for 

which they are responsible. For example, material may be present in stock vials, 

ampoules, Thin Layer Chromatography or High Pressure Liquid Chromatography

samples, etc., and in various waste forms; materials may be stored in refrigerators, 

freezers, cold rooms, lab rooms, etc.

• Periodically, each AU should submit to the RSO an inventory of all licensed materials in 

the laboratory. (Note: the licensee should state in its radiation safety program 

procedures the frequency of such inventory submissions. It may be weekly, monthly, or 

quarterly, or after each order, depending on the frequency of use and the amount of 

materials on hand). Each AU should indicate if material they possessed was disposed 

of or transferred from their responsibility (examples: waste in containers may be

transferred to a common decay-in-storage (DIS) location under the responsibility of the 
I–4

RSO or another AU; or the AU may have disposed of licensed material to the sewer; or 

the AU may have transferred a vial of material to another AU.)

• The license accountability log (inventory) may be maintained in hard-copy or 

electronic records.

Sample Transfer Policy Statements

Internal Transfers

Licensed materials that may be transferred from one department or laboratory or AU’s control to 

another should have prior approval from the RSO. A written transfer procedure should be 

developed by the RSO to ensure that transfers are completed in accordance with the conditions 

of the license. All transfers must be done in a way that minimizes the probability of spillage or 

breakage. Double containers should be used, including suitable shielding, for such transfers.

External Transfers

Licensed material should not be transferred or shipped from one institution to another without 

the approval of the RSO. Such transfers or shipments must be packaged and labeled in 

accordance with U.S. Department of Transportation (DOT), NRC, and U.S. Postal Service 

Regulations, whichever is applicable. Before any transfer from the licensee, the licensee must 

verify that the recipient is authorized to receive the licensed material, as required by 

10 CFR 30.41, 40.51, and 70.42.

If a Category 1 or Category 2 sealed source listed in Appendix E to 10 CFR Part 20 (i.e., a 

nationally tracked source) is being shipped, it must be tracked in the NSTS in accordance with 

10 CFR 20.2207. The regulations in 10 CFR 20.2207 require that each licensee that 

manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source 

shall complete and submit a NSTTR to the NRC. The NSTTRs are maintained in the NSTS, a 

secure computer system that tracks Category 1 and Category 2 nationally tracked sources from 

the time they are manufactured or imported through the time of their disposal or export, or until 

the source activity decays to below Category 2.

Donations

On occasion, licensees may be offered or have donated licensed materials by other individuals 

(e.g., a retiring medical practitioner donating his cesium-137 needles to the university medical 

center). All such donations of radioactive materials must be transferred to the licensee and 

handled in accordance with NRC requirements and the conditions of the license. In any case, 

the RSO should approve the donation prior to the transfer.
APPENDIX J

GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL MEMBERS OF THE 

PUBLIC WILL NOT RECEIVE DOSES EXCEEDING THE ALLOWABLE LIMITS

J–1

Guidance for Demonstrating that Individual Members of the 

Public Will Not Receive Doses Exceeding the Allowable Limits

This appendix describes methods for determining radiation doses to members of the public.

Licensees must ensure that:

• The radiation dose received by individual members of the public does not exceed 

1 millisievert (mSv) [100 millirem (mrem)] in 1 calendar year resulting from the licensee’s 

possession or use of licensed materials.

• The radiation dose in unrestricted areas does not exceed 0.02 mSv [2 mrem] in any 

1 hour.

• Air emissions of radioactive material to the environment, excluding radon-222 and its 

daughters, will not result in a total effective dose equivalent (TEDE) in excess of 0.1 mSv

[10 mrem] per year. As required by in Title 10 of the Code of Federal Regulations

(10 CFR) 20.1101(d), if the licensee exceeds the 0.1 mSv [10 mrem] per year air 

emission dose constraint, the licensee must report the exceedance, as provided in 

10 CFR 20.2203, and promptly take appropriate corrective action to ensure 

against recurrence.

Members of the public include persons who live, work, study, or may be near locations where

licensed material is used or stored and employees whose assigned duties do not include the 

use of licensed material but who may work in the vicinity where such materials are used 

or stored.

Doses to Members of the Public

INCLUDES doses from

• radiation or radioactive material released 

by a licensee

• sources of radiation under the control of a 

licensee

• effluents from sources of licensed 

radioactive materials

• licensed material in transportation or 

storage at the licensee’s facility

DOES NOT INCLUDE doses from

• sanitary sewerage discharges from licensee

action taken in accordance with 

10 CFR 20.2003

• natural background radiation

• medical administration of radioactive material

including patients released under 

10 CFR 35.75

• voluntary participation in medical research
J–2

As defined in 10 CFR 20.1003, the term unrestricted area means “an area, access to which is 

neither limited nor controlled by the licensee.” For purposes of this definition in 20.1003, an 

“unrestricted area” is an area where access is neither limited nor controlled by the licensees for 

purposes of limiting exposures to radiation and radioactive materials. An “unrestricted area” for 

purposes of 20.1003 may be controlled for other purposes, such as for security purposes 

(see, e.g., 10 CFR 20.1801 and 20.1802), and still be considered an “unrestricted area” as long 

as it is not required to be controlled for limiting exposure to radiation and radioactive materials. 

Typical unrestricted areas may include offices, shops, areas outside buildings, property, and 

storage areas for nonradioactive materials, and other facilities and laboratories where licensed 

materials are not normally used or stored.

The licensee must show compliance with the annual dose limit for individual members of the 

public by

• demonstrating by measurement or calculation that the TEDE to the individual likely to 

receive the highest dose, in an unrestricted area from licensed operations, does not 

exceed 1 mSv [100 mrem] in a year, or 

• demonstrating that the annual average concentration of radioactive material released in 

gaseous and liquid effluents at the boundary of the unrestricted area does not exceed 

the values specified in Table 2, “Effluent Concentrations,” of Appendix B to 

10 CFR Part 20. The licensee must also show that if an individual were continuously 

present in an unrestricted area, the dose from external sources would not exceed 

0.02 mSv [2 mrem] in 1 hour and 0.5 mSv [50 mrem] in a year, and

• demonstrating that air emissions of radioactive materials to the environment, excluding 

radon-222 and its daughters, do not result in doses greater than the constraint limit of 

0.1 mSv [10 mrem] TEDE from those emissions

To perform a dose assessment, the licensee should identify all potential sources of external and 

internal radiation exposure to members of the public and all locations of use, transport, and 

storage of radioactive material at the facility. The licensee must then take radiation 

measurements or perform calculations to demonstrate compliance.

Measurements

The licensee may use measurements to demonstrate that the average annual releases are 

within regulatory limits, as well as to demonstrate that the TEDE to the individual likely to 

receive the highest dose at the boundary of the unrestricted area does not exceed 1 mSv 

[100 mrem] in a year. These measurements may include

• dose rate surveys for radiation exposures from external radiation sources

• measurements of radionuclides in air and water effluents

• use of environmental dosimeters in unrestricted areas

The method used to measure dose will depend on the nature of the radiation source. If the 

source of radiation is constant, it may be adequate to measure the dose rate and integrate it 

over time. If the source of radiation differs or changes over time, it may be necessary to 

perform continuous measurements.
J–3

Radioactivity releases may be determined by effluent monitoring or effluent sampling and 

analysis. Airborne effluents may be discharged when volatile materials are used, such as 

during iodination’s, but the discharge is usually not continuous because volatile materials are 

often used periodically rather than continuously. Liquid effluents may be discharged 

continuously or may be stored and subsequently discharged on a batch basis. For each type of 

source and for each route of potential exposure, consider the location of measurement points,

whether continuous or periodic monitoring is required, the frequency of sampling and 

measurement, and any additional information. For discharges of airborne radionuclides, for 

example, it may be necessary to obtain information on the efficiency of filters and the air flow 

rate of the discharge system, as well as meteorological data and the distance to the nearest 

individual member of the public.

Calculation Method

Using a calculation method, the licensee must determine the highest dose an individual is likely 

to receive in an unrestricted area from licensed operations. The licensee must take into account 

the individual’s exposure from external sources and the concentration of radionuclides in 

gaseous and liquid releases. In practice, the licensee may wish to make conservative 

assumptions to simplify the dose calculation.

The public dose limit applies to the individual who is likely to receive the highest dose from 

licensed operations. Therefore, the dose calculations must consider the location with the 

potential for the highest internal and external exposures. The occupancy factor for an area is 

defined as the average fraction of time the maximally exposed individual is present and exposed 

to a radiation source. If a source is used intermittently, the occupancy factor is a fraction of the 

hours in a week that a given person would occupy the area. If the result of the calculation using 

an occupancy factor of 1 demonstrates that the public dose limit is not exceeded, then there is 

no need for further evaluation.

If, however, the licensee would rather choose a more realistic assumption of the individual’s 

occupancy at the points of highest internal and external exposures, then the licensee may use 

the occupancy factors in Table J–1 or may calculate a specific occupancy factor by determining 

the likely fraction of time that the individual is present. The occupancy factors in Table J–1 are 

general guidance values and may be used if more detailed information is not available.
J–4

Table J–1. Standard Occupancy Factors1

Occupancy Factor Description

1 Full occupancy areas such as administrative and clerical offices, 

receptionist areas, laboratories, pharmacies and other work areas fully 

occupied by an individual, attended waiting rooms, and occupied space in 

nearby buildings

1/2 Areas where individuals are present for a major part of the day 

1/5 Corridors, employee lounges, staff rest rooms, and classrooms

1/20 Unattended waiting rooms, public rest rooms, unattended vending rooms, 

storage areas, janitor’s closets, attics, outdoor areas with seating, and 

recreational areas

1/40 Outdoor areas with only transient pedestrian or vehicular traffic, 

unattended parking lots, vehicular drop off areas (unattended), stairways, 

and unattended elevators 

Records

In accordance with 10 CFR 20.2107, the licensee must maintain records to demonstrate 

compliance with the dose limit for individual members of the public until the Commission 

terminates the license. In general, survey and monitoring records of ambient radiation and 

effluent radioactivity should be adequate.

Records demonstrating the dose to an individual member of the public should identify the 

instruments used in the survey; the name of the surveyor; the date of the survey; the location of 

the surveys, including a description or drawing of the areas surveyed; survey results; and if 

applicable, the occupancy factors used and justification for their use. In addition, records 

demonstrating the dose to an individual member of the public that involve effluent sampling 

analysis should include information on concentrations of specific radionuclides, minimum 

detectable activity of the system, and the estimated uncertainty of measurements.

 

1Adapted from NCRP Report No. 147, “Structural Shielding Design for Medical X-Ray Imaging Facilities,” issued 

November 19, 2004 and NCRP Report No. 151, “Structural Shielding Design and Evaluation for MegaVoltage X- and

Gamma-Ray Radiotherapy Facilities,” issued December 31, 2005
APPENDIX K

GENERAL TOPICS FOR SAFE POSSESSION AND USE OF RADIOACTIVE 

MATERIALS AND MODEL EMERGENCY PROCEDURES

K–1

General Topics for Safe Possession and Use of Radioactive 

Materials and Model Emergency Procedures

This appendix describes general topics for safe possession and use of radioactive materials and

procedures for handling and reporting emergencies.

General Topics for Safe Possession and Use of Radioactive Materials

Each area where radioactive material is used or stored should have general rules, so that 

workers know what is required. Typical instructions should include the following:

• Wear a laboratory coat or other protective clothing at all times in areas where licensed 

materials are used.

• Wear disposable gloves at all times when handling licensed materials.

• After each procedure or before leaving the area, monitor hands, shoes, and clothing for 

contamination in a low-background area.

• Do not eat, drink, smoke, or apply cosmetics in any area where licensed material is 

stored or used.

• Do not store food, drink, or personal effects in areas where licensed material is stored or 

used (see Figure K–1).

• Wear personnel monitoring devices, if required, at all times while in areas where

licensed materials are used or stored.

• Dispose of radioactive waste only in designated, labeled, and properly 

shielded receptacles.

• Never pipette by mouth.

• Store radioactive solutions in clearly labeled containers.

• Secure all licensed material when it is not under the constant surveillance and 

immediate control of the users.

Figure K–1. Storage of Food and Drink. Food or drink may not be stored in refrigerators 

with radionuclides.
K–2

Security of Radioactive Materials

• Licensed materials in use in controlled or unrestricted areas must be under 

constant surveillance.

• Licensed materials will be secured by one or more of the following methods.

— storing and using licensed materials only in restricted areas

— limiting access to an entire facility or building or portion of the building to 

radiation workers

— providing storage areas that can be locked to prevent access to the 

licensed material

— implementing procedures that require a radiation worker to be within “line of 

sight” of the materials whenever licensed materials are in use

Radionuclide-specific Procedures

Licensees should develop written procedures for use of different radionuclides so that users 

know the types of shielding, protective clothing, radiation survey instruments, surveys, and 

decontamination activities that are required. Examples of such procedures are included below.

Example 1:

If requesting more than 37 MBq [1 mCi] of iodine-125 or iodine-131, special safety instructions 

should be provided to users, including the following:

• A mandatory radiation survey and wipe test for radioactive contamination after each use

• Bioassay procedures for individuals working with millicurie quantities of radioiodine

• The use of vented hoods for iodination and for the storage of millicurie quantities 

of radioiodine

• A dry run prior to the performance of unfamiliar procedures, in order to preclude unexpected 

complications; also recommended that the Radiation Safety Officer (RSO) be present during

new procedures

• Procedures for measuring the concentration of radioiodine effluents from the hoods
K–3

Example 2:

If requesting more than 37 MBq [1 mCi] of phosphorus-32, special safety instructions should be 

provided to users, including the following:

• The use of shielding with low atomic number material, such as high-density plastic, to keep 

bremsstrahlung radiation to a minimum

• A mandatory radiation survey and wipe test for radioactive contamination after each use

• The use of extremity monitors for procedures that involve 37 MBq [1 mCi] or more

• A dry run prior to the performance of unfamiliar procedures to preclude unexpected 

complications; also recommended that the RSO be present during new procedures

• The use of eye protection for procedures that involve 370 MBq [10 mCi] or more

Sample Procedures for Handling Emergencies

Appropriate first aid and other immediate medical needs of injured individuals should not be 

neglected, delayed, or ignored due to suspected contamination. 

General Safety Procedures to Handle Spills

• Name and telephone number of RSO or alternate persons should be posted 

conspicuously in areas of use, so that it is readily available to workers in case of 

emergencies. The licensee should have emergency equipment readily available for 

handling spills. Spill kits should include the following:

— disposable gloves

— housekeeping gloves

— disposable lab coats

— disposable head coverings

— disposable shoe covers

— roll of absorbent paper with plastic backing

— masking tape

— plastic trash bags with twist ties

— “Radioactive Material” labeling tape

— marking pen

— pre-strung “Radioactive Material” labeling tags
K–4

— box of wipes

— instructions for “Emergency Procedures”

— clipboard with a copy of the Radioactive Spill Report Form for the facility

— pencil

— appropriate radiation survey instruments, including batteries (for radiation 

survey meters)

Minor Spills of Liquids and Solids

• Instructions to Workers

— Notify persons in the area that a spill has occurred.

— Prevent the spread of contamination by covering the spill with absorbent paper. 

(Paper should be dampened if solids are spilled.)

— Clean up the spill, wearing disposable gloves and using absorbent paper.

— Carefully fold the absorbent paper with the clean side out and place in a plastic 

bag for transfer to a radioactive waste container. Put contaminated gloves and 

any other contaminated disposable material in the bag.

— Survey the area with an appropriate low-range radiation survey meter or other 

appropriate technique. Check the area around the spill for contamination. Also

check hands, clothing, and shoes for contamination.

— Report the incident to the RSO promptly.

— Allow no one to return to work in the area unless approved by the RSO.

— Cooperate with RSO and RSO’s staff (e.g., investigation of root cause, provision 

of requested bioassay samples).

— Follow the instructions of the RSO and RSO’s staff (e.g., decontamination 

techniques, surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

— Follow up on the decontamination activities and document the results.

— As appropriate, determine cause and corrective actions needed; consider 

bioassays if licensed material may have been ingested, inhaled, or absorbed 

through the skin.

— If necessary, notify U.S. Nuclear Regulatory Commission (NRC).
K–5

Major Spills of Liquids and Solids

• Instructions to Workers

— Clear the area. If appropriate, survey all persons not involved in the spill and 

vacate the room.

— Prevent the spread of contamination by covering the spill with absorbent paper 

(paper should be dampened if solids are spilled), but do not attempt to clean it 

up. To prevent the spread of contamination, limit the movement of all personnel 

who may be contaminated.

— Shield the source only if it can be done without further contamination or 

significant increase in radiation exposure.

— Close the room and lock or otherwise secure the area to prevent entry. Post the 

room with a sign to warn anyone trying to enter that a spill of radioactive material 

has occurred.

— Notify the RSO immediately.

— Survey all personnel who could possibly have been contaminated. 

Decontaminate personnel by removing contaminated clothing and flushing 

contaminated skin with lukewarm water and then washing with a mild soap.

— Allow no one to return to work in the area unless approved by the RSO.

— Cooperate with RSO and RSO’s staff (e.g., investigation of root cause, provision 

of requested bioassay samples).

— Follow the instructions of the RSO and RSO’s staff (e.g., decontamination 

techniques, surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

— Confirm decontamination of personnel. If decontamination of personnel was not 

fully successful, consider inducing perspiration by covering the area with plastic. 

Then wash the affected area again to remove any contamination released by 

the perspiration.

— Supervise decontamination activities and document the results. Documentation 

should include location of surveys and decontamination results.

— Determine cause and needed corrective actions; consider need for bioassays if 

licensed material may have been ingested, inhaled, or absorbed through 

the skin.

— If necessary, notify the NRC.
K–6

Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases

• Instructions to Workers

— Notify all personnel to vacate the room immediately.

— Shut down ventilation system, if appropriate, to prevent the spread of 

contamination throughout the system and other parts of the facility.

— Vacate the room. Seal the area, if possible.

— Notify the RSO immediately.

— Ensure that all access doors to the area are closed and posted with appropriate

warning signs, or post guards (trained) at all access doors to prevent accidental 

opening of the doors or entry to the area.

— Survey all persons who could have possibly been contaminated. Decontaminate,

as directed by the RSO.

— Promptly report suspected inhalation and ingestion of licensed material to 

the RSO.

— Decontaminate the area only when advised or supervised by the RSO.

— Allow no one to return to work in the area unless approved by the RSO.

— Cooperate with RSO and RSO’s staff (e.g., investigation of root cause, provision 

of requested bioassay samples).

— Follow the instructions of the RSO and RSO’s staff (e.g., decontamination 

techniques, surveys, provision and collection of bioassay samples, 

requested documentation).

• Reminders to RSO

— Supervise decontamination activities.

— Perform air sample surveys in the area before permitting resumption of work with 

licensed materials.

— Provide written directions to potentially contaminated individuals about providing 

and collecting urine, breath, blood, or fecal samples, etc.

— Consider the need for a medical exam or whole body count before permitting 

involved individuals to return to work with licensed material.

— Determine cause and corrective actions needed; consider need for bioassays if 

licensed material may have been ingested, inhaled, or absorbed through the 

skin. Document the incident.

— If necessary, notify the NRC.
K–7

Minor Fires

• Instructions to Workers (Licensees should develop procedures and instructions, in 

accordance with local fire safety requirements, Occupational Safety and Health 

Administration (OSHA) regulations, etc., and provide training as needed)

— Immediately attempt to put out the fire by approved methods (i.e., fire 

extinguisher) if other fire hazards or radiation hazards are not present.

— Notify all persons present to vacate the area and have one individual immediately 

call the RSO and fire department (as instructed by the RSO).

— Once the fire is out, isolate the area to prevent the spread of 

possible contamination.

— Survey all persons involved in combating the fire for possible contamination.

— Decontaminate personnel by removing contaminated clothing and flushing 

contaminated skin with lukewarm water, then washing with a mild soap.

— In consultation with the RSO, determine a plan of decontamination and the types 

of protective devices and survey equipment that will be necessary to 

decontaminate the area.

— Allow no one to return to work in the area unless approved by the RSO.

— Cooperate with the RSO and RSO’s staff (e.g., investigation of root cause,

provision of requested bioassay samples).

— Follow the instructions of the RSO and RSO’s staff (e.g., decontamination 

techniques, surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

— Supervise decontamination activities.

— If decontamination of personnel was not fully successful, consider inducing 

perspiration by covering the area with plastic. Then wash the affected area again 

to remove any contamination released by the perspiration.

— Consult with fire safety officials to ensure that there are no other possibilities of 

another fire starting.

— Determine cause and needed corrective actions; consider need for bioassays if 

licensed material may have been ingested, inhaled, or absorbed through the 

skin. Document the incident.

— If necessary, notify the NRC.
K–8

Fires, Explosions, or Major Emergencies

• Instructions to Workers

— Notify all persons in the area to leave immediately.

— Notify the fire department.

— Notify the RSO and other facility safety personnel.

— Upon arrival of firefighters, inform them where radioactive materials are stored or 

where radionuclides were being used; inform them of the present location of the 

licensed material and the best possible entrance route to the radiation area, as 

well as any precautions to avoid exposure or risk of creating radioactive 

contamination by use of high-pressure water, etc.

— Cooperate with RSO and RSO’s staff (e.g., investigation of root cause, provision 

of requested bioassay samples).

— Allow no one to return to work in the area unless approved by the RSO.

— Follow the instructions of the RSO and RSO’s staff (e.g., decontamination 

techniques, surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

— Coordinate activities with facility’s industrial hygienist or environmental health 

and safety office, and with local fire department.

— Consult with the firefighting personnel and set up a controlled area where the 

firefighters can be surveyed for contamination of their protective clothing and 

equipment after the fire is extinguished.

— Once the fire is extinguished, do not allow the firefighters to enter the radiation 

area until a thorough evaluation and survey are performed to determine the 

extent of the damage to the licensed material use and storage areas.

— Perform thorough contamination surveys of the firefighters and their equipment 

before they leave the controlled area and decontaminate, if necessary.

— Supervise decontamination activities.

— Consider bioassays if licensed material may have been ingested, inhaled, or 

absorbed through the skin. Document the incident.

— Notify the NRC.
K–9

Incidents Involving Sealed Sources

For an emergency situation that may occur concerning a sealed source that has been 

exposed unintentionally, is unshielded, or is compromised, the following safety instructions 

should be considered:

• Immediately secure and post the restricted area; maintain continuous surveillance and 

restrict access to the restricted area.

• Notify the RSO, RSO designee, and management personnel immediately.

• Retrieval operations should be supervised by the RSO.

• No source or suspected source should be handled directly with bare hands.

• Determine if additional dosimetry will be required during source retrieval.

• Appropriate survey instruments should be used for the response activity.

• Expedient methods of reducing unintended exposure to staff and the public, such as 

lead shot bags, sandbags, steel plates, and remote handling devices.

• The RSO should make required notifications to the NRC.

Copies of emergency procedures should be provided to all users. Post a current copy in each 

laboratory or other area where radioactive material is used.

Procedures for Collecting Bioassay Samples

If an individual becomes contaminated or exposed to radioactive material through skin 

absorption, ingestion, or inhalation, the RSO or a member of the RSO’s staff should estimate 

the amount of material taken into the body. The following items should be considered in 

developing procedures for collecting bioassay samples:

• the type of bioassay that must be performed (direct or indirect)

• the number of samples or data points to be collected

• the frequency of sampling (e.g., hourly, daily, weekly, once)

• the size of the sample to be collected (e.g., 24-hour urine collection)

• the ease or difficulty of sample collection

• the need for written instructions to be provided to the sample collector, who may be the 

contaminated individual

APPENDIX L

TYPICAL U.S. NUCLEAR REGULATORY COMMISSION (NRC)

NOTIFICATION AND REPORTING REQUIREMENTS FOR INCIDENTS

L–1

Typical U.S. Nuclear Regulatory Commission (NRC) 

Notification and Reporting Requirements for Incidents

Note: The following list of notification and reporting requirements is provided to inform 

licensees about typical notification and reporting requirements that apply to their licensed 

activities. Licensees should note that the list is incomplete in that not all potentially 

applicable requirements have been included. Also, notification and reporting requirements 

change; therefore, licensees should consult the regulations for definitive information about 

current requirements.

Table L–1. Typical NRC Notification and Reporting Requirements for Incidents

Event Telephone Notification Written Report

Regulatory 

Requirement

Package received 

with removable 

radioactive surface 

contamination 

exceeding the limits 

of 10 CFR 71.87(i) or 

external radiation 

levels exceeding the 

limits of 

10 CFR 71.47

Immediate (NRC and the 

final delivery carrier must 

be notified)

none 10 CFR 20.1906(d)

Theft or loss of 

licensed material

Immediate 30 days 10 CFR 20.2201(a)(1)(i)

10 CFR 20.2201(b)(1)

Whole body dose 

greater than 0.25 Sv 

[25 rems]

Immediate 30 days 10 CFR 20.2202(a)(1)(i)

10 CFR 20.2203(a)(1)

Extremity dose 

greater than 2.5 Gy

[250 rads]

Immediate 30 days 10 CFR 20.2202(a)(1)(iii)

10 CFR 20.2203(a)(1)

Whole body dose 

greater than 0.05 Sv 

[5 rems] in 24 hours

24 hours 30 days 10 CFR 20.2202(b)(1)(i)

10 CFR 20.2203(a)(1)

Extremity dose 

greater than 0.5 Sv 

[50 rems] in 24 hours

24 hours 30 days 10 CFR 20.2202(b)(1)(iii)

10 CFR 20.2203(a)(1)

Whole body dose 

greater than 0.05 Sv 

[5 rems]

None 30 days 10 CFR 20.2203(a)(2)(i)
L–2

Table L–1. Typical NRC Notification and Reporting Requirements for Incidents

(Continued)

Event Telephone Notification Written Report

Regulatory 

Requirement

Dose to individual 

member of public

greater than 1 mSv 

[0.1 rem]

None 30 days 10 CFR 20.2203(a)(2)(iv)

Defect in equipment 

that could create a 

substantial safety 

hazard

2 days 30 days 10 CFR 21.21(d)(3)(i) 

& (ii)

Event that prevents 

immediate protective 

actions necessary to 

avoid exposures to 

radiation or 

radioactive materials 

that could exceed 

regulatory limits

Immediate 30 days 10 CFR 30.50(a) 

& (c)(2); 40.60(a) 

& (c)(2); and 70.50(a) 

& (c)(2)

Unplanned 

contamination event 

that requires 

restricted access for 

more than 24 hours 

and involves a 

quantity of material 

greater than five 

times the lowest 

annual limit on intake 

for the material as 

specified in 

Appendix B of 

10 CFR Part 20 and 

requires the area to 

be restricted for a 

reason other than to 

allow radionuclides 

with half-lives less 

than 24 hours to 

decay

24 hours 30 days 10 CFR 30.50(b)(1) 

& (c)(2); 40.60(b)(1) 

& (c)(2) and 70.50(b)(1) 

& (c)(2)
L–3

Table L–1. Typical NRC Notification and Reporting Requirements for Incidents

(Continued)

Event Telephone Notification Written Report

Regulatory 

Requirement

Equipment is 

disabled or fails to 

function as designed 

when required to 

prevent radiation 

exposure in excess 

of regulatory limits 

24 hours 30 days 10 CFR 30.50(b)(2) 

& (c)(2); 40.60(b)(2) 

& (c)(2); and 70.50(b)(2) 

& (c)(2)

An event that 

requires unplanned 

medical treatment at 

a medical facility of 

an individual with 

spreadable 

radioactive 

contamination on the 

individual’s clothing 

or body

24 hours 30 days 10 CFR 30.50(b)(3) 

& (c)(2); 40.60(b)(3) 

& (c)(2) ; and 70.50(b)(3) 

& (c)(2)

Unplanned fire or 

explosion that affects 

the integrity of any 

licensed material or 

device, container, or 

equipment with 

licensed material

24 hours 30 days 10 CFR 30.50(b)(4) 

& (c)(2); 40.60(b)(4) 

& (c)(2); and 70.50(b)(4) 

& (c)(2)
L–4

Table L–1. Typical NRC Notification and Reporting Requirements for Incidents

(Continued)

Event Telephone Notification Written Report

Regulatory 

Requirement

Determination that 

any licensee that has 

not previously 

implemented the 

Security Orders 

(i.e., orders issued by 

the NRC to require 

licensees to 

implement interim 

security measures) 

or been subject to 

the provisions of 

10 CFR Part 37, 

Subpart C will 

aggregate 

radioactive material 

to a quantity that 

equals or exceeds 

the Category 2 

threshold

None 90 days before 

aggregating 

radioactive 

material to a 

quantity that 

equals or 

exceeds the 

Category 2 

threshold

10 CFR 37.41(a)(3)

Coordination with 

local law 

enforcement agency 

(LLEA) has failed, 

either because the 

LLEA has not 

responded or 

because the LLEA 

does not plan to 

participate

3 business days Submittal of a 

written report 

concerning 

failures of 

coordination with 

LLEA as 

described in 

10 CFR 37.45(b) 

is not required; 

however, 

licensees must 

document their 

efforts to 

coordinate with 

the LLEA and 

keep this 

documentation for 

3 years

10 CFR 37.45(b)&(c)
L–5

Table L–1. Typical NRC Notification and Reporting Requirements for Incidents

(Continued)

Event Telephone Notification Written Report

Regulatory 

Requirement

Determination that an 

unauthorized entry

resulted in an actual 

or attempted theft, 

sabotage, or 

diversion of 

Category 1 or 

Category 2 quantity 

of radioactive 

material 

As soon as possible

(but not at the expense of 

causing delay or interfering 

with the LLEA response), 

but no later than 4 hours 

after discovery

30 days 10 CFR 37.57(a)&(c) 

Assessment of any 

suspicious activity 

related to possible 

theft, sabotage, or 

diversion of 

Category 1 or 

Category 2 quantities 

of radioactive 

material

As soon as possible, but 

no later than 4 hours after 

notifying the LLEA

none 10 CFR 37.57(b)

Determination that a 

shipment containing 

a Category 1 quantity 

of material is lost or 

missing in transport

Within 1 hour of the 

determination; also notify 

LLEA within 1 hour of 

determination

30 days and 

periodic updates

(if subsequent 

substantive 

information) 

10 CFR 37.81(a)(g)&(h)

Determination that a 

shipment containing 

a Category 2 quantity 

of material is lost or 

missing in transport

Within 4 hours of the 

determination and again 

within 24 hours if the 

material has not yet been 

located and secured

30 days and 

periodic updates

(if subsequent 

substantive 

information)

10 CFR 37.81(b)(g)&(h)

Discovery along the 

route of any actual or 

attempted theft or 

diversion, or 

suspicious activity, 

related to a 

Category 1 quantity 

of material in 

transport

As soon as possible upon 

discovery. Also notify 

LLEA as soon as possible

upon discovery

30 days 

(except no report 

for suspicious 

activity) and 

periodic updates

after report 

(if subsequent 

substantive 

information)

10 CFR 37.81(c)(g)&(h)
L–6

Table L–1. Typical NRC Notification and Reporting Requirements for Incidents

(Continued)

Event Telephone Notification Written Report

Regulatory 

Requirement

Discovery of any 

actual or attempted 

theft or diversion, or 

suspicious activity, 

related to a 

Category 2 quantity 

of material in 

transport

As soon as possible 30 days 

(except no report 

for suspicious 

activity) and 

periodic updates

after report 

(if subsequent 

substantive 

information)

10 CFR 37.81(d)(g)&(h)

Upon recovery of any 

lost or missing 

Category 1 quantity 

of material

As soon as possible. Also 

notify the LLEA as soon 

as possible

To be included in 

the 30-day report 

of an event 

described in 

10 CFR 37.81(g), 

if recovered during 

that time or in a 

subsequent 

update

10 CFR 37.81(e)&(h)

Upon recovery of any 

lost or missing 

Category 2 quantity 

of material

As soon as possible To be included in 

the 30-day report 

of an event 

described in 

10 CFR 37.81(g), 

if recovered during 

that time or in a 

subsequent 

update

10 CFR 37.81(f)&(h)

Note: Telephone notifications must be made to the NRC Operations Center at 301-816-5100 or 

by facsimile to 301-816-5151, except as noted. The Center is staffed 24 hours a day and 

accepts collect calls.
APPENDIX M

RADIATION SAFETY SURVEY TOPICS

M–1

Radiation Safety Survey Topics

This Appendix provides applicants and licensees with additional information on surveys, 

including training requirements, survey frequency, contamination limits, and bioassays.

Training

Before independently performing radiation surveys, an individual should complete both 

classroom and on-the-job training as follows:

• Classroom training may be in the form of lecture, video, computer-based, or self-study 

and will cover the following subject areas:

— principles and practices of radiation protection

— radioactivity measurements, monitoring techniques, and using instruments

— usage and basic mathematics and calculations for measuring radioactivity

— biological effects of radiation

• Appropriate on-the-job-training consists of the following:

— observing authorized personnel using survey equipment, collecting samples, and 

analyzing samples

— using survey equipment, collecting samples, and analyzing samples under the 

supervision and in the physical presence of an individual authorized to 

perform surveys

Facilities and Equipment

• To ensure achieving the required sensitivity of measurements, survey samples will be 

analyzed in a low-background area.

• A gamma counter system with a single- or multi-channel analyzer can be used to count 

samples containing gamma-emitters (e.g., iodine-125, cesium-137, cobalt-60).

• A liquid scintillation counting (LSC) system can be used to count samples containing 

most beta-emitters and gamma-emitters (if efficiency is great enough to achieve the 

required sensitivity for measurements). The LSC is the most common instrument used 

for measurement of tritium (H-3) contamination and other low-energy beta-emitters 

commonly used in laboratory research and development, such as carbon-14 and

sulfur-35.

• Licensees may use a gas-flow proportional counting system to count samples containing 

alpha-emitters, beta-emitters, and gamma-emitters (if efficiency is great enough to 

achieve the required sensitivity for measurements).
M–2

Ambient Radiation Level Surveys

• Dose-rate surveys, at a minimum, should be performed in locations where workers are 

exposed to radiation levels that might result in radiation doses in excess of 10 percent of 

the occupational dose limits or where an individual is working in a dose rate of 

0.025 mSv (millisievert) [2.5 mrem/h (millirem/hour)] or more [50 mSv/year divided by 

2,000 h/year]. It is also recommended that area monitors be used in areas where 

high-energy gamma/photon-emitting radioactive materials or radiation are produced 

and handled.

• Title 10 of the Code of Federal Regulations (10 CFR) 20.1301 requires that the total 

effective dose equivalent to an individual member of the public from the licensed 

operation does not exceed 1 mSv [0.1 rem] in a year, and the dose in any unrestricted 

area from external sources does not exceed 0.02 mSv [2 mrem] in any 1 hour.

The frequency of ambient surveys depends on the quantity and use of radioactive materials, as 

well as the specific facilities, equipment, and procedures designed to protect the worker and 

members of the public from external exposure to radiation. While the regulations do not specify 

a specific survey frequency, the licensee must conduct surveys to ensure that the dose rate 

limits in 10 CFR Part 20 Subparts C and D are not exceeded.

Contamination Surveys

Licensees’ contamination surveys should be sufficient to identify areas of contamination that 

might result in doses to workers or to the public. Combined removable and fixed contamination 

should be surveyed using appropriate radiation-detection equipment. Removable contamination 

can be detected and measured through a wipe test of the surface, which is counted in an 

appropriate counting instrument, such as a liquid scintillation counter, a sodium iodide or 

germanium gamma counter, or a proportional alpha/beta counter. 

Contamination surveys must be made as required by 10 CFR 20.1501. Surveys are 

usually performed:

• to evaluate radioactive contamination that could be present on surfaces of floors, walls, 

laboratory furniture, and equipment

• after any spill or contamination event

• when procedures or processes have changed

• to evaluate the potential contamination of users and the immediate work area, at the end 

of the day or before leaving the area of use, when licensed material is used

• in unrestricted areas at frequencies consistent with the types and quantities of materials 

in use but generally not less frequently than quarterly

• in areas adjacent to restricted areas and in all areas through which licensed materials 

are transferred and temporarily stored before shipment
M–3

Contamination Survey Frequency

Personnel should survey for contamination in locations where individuals are working with an 

unsealed form of radioactive material. These surveys should be done at a frequency 

appropriate to the types and quantities of radioactive materials in use (see Table M–1). If the 

activity used is greater than or equal to the smallest annual limit on intake (ALI) (for either 

inhalation or ingestion) as identified in 10 CFR Part 20, Appendix B, then documented surveys 

should be performed at least daily and records retained in accordance with 10 CFR 20.2103.

Table M–1 contains suggested contamination survey frequencies based on ALIs. The 

suggested frequency of surveys is based on the amount of licensed material “in use” at any one 

time at any particular location. If licensed material has not been used for a period of time 

greater than the required survey frequency, then it is considered to be “not in use.”

Table M–1. Suggested Contamination Survey Frequency

< 0.1 ALI ≥ 0.1 ALI < 1.0 ≥ 1.0 ALI

In Use Monthly Weekly Daily

Not in Use Every 6 Months

Contamination in Unrestricted Areas

Contamination found in unrestricted areas should be immediately decontaminated to 

background levels. When it is not possible to get to background levels, the licensee must 

ensure that the amounts do not exceed the contamination levels listed in Table M–2, taken from 

“Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted 

Use or Termination of Licenses for Byproduct, Source, or Special Nuclear Material” 

(August 1987) (ADAMS Accession No. ML030590504). Note that, for the purposes of release 

of facilities for unrestricted use or termination of the license, these values have been 

superseded by 10 CFR 20, Subpart E, “Radiological Criteria for License Termination,” and 

cannot be used for that purpose. In particular, the acceptable contamination levels listed below 

for most alpha emitters exceed the levels that will meet the 10 CFR 20, Subpart E criteria. 

Table M–2 levels can continue to be used for release of equipment and material from 

licensed material facilities during operational activities prior to license termination.

(63 FR 64132, Nov. 18, 1998)

For equipment that is potentially contaminated and is to be released for unrestricted use, 

Table M–2 provides the maximum acceptable residual levels for equipment. Additional 

guidance for release of equipment can be found in NUREG–1575, Supplement 1, “Multi-Agency 

Radiation Survey and Assessment of Materials and Equipment Manual (MARSAME).”

Table M–2 values also may be acceptable criteria for contamination in facilities during facilities 

in operation.

A standardized method for smear testing of a relatively uniform area should be used to aid in 

comparing contamination at different times and places. A smear taken from an area of 100 cm2

is acceptable to indicate levels of removable contamination.
M–4

Table M–2. Acceptable Surface Contamination Levels for Equipment

Nuclide1 Average2,3,6 Maximum2,4,6 Removable2,5,6

U-nat, U-235, U-238, 

and associated 

decay products

83.3 Bq/100 cm2 

[5,000 dpm/100 cm2]

250 Bq/100 cm2 

[15,000 dpm/100 cm2]

16.7 Bq/100 cm2

[1,000 dpm/100 cm2]

Transuranics, Ra-226, 

Ra-228, Th-230, 

Th-228, Pa-231, 

Ac-227, I-125, I-129

1.7 Bq/100 cm2

[100 dpm/100 cm2]

5.0 Bq/100 cm2

[300 dpm/100 cm2]

0.3 Bq/100 cm2

[20 dpm/100 cm2]

Th-nat, Th-232, Sr-90, 

Ra-223, Ra-224, 

U-232, I-126, I-131, 

I-133

16.7 Bq/100 cm2

[1,000 dpm/100 cm2]

50.0 Bq/100 cm2

[3,000 dpm/100 cm2]

3.3 Bq/100 cm2

[200 dpm/100 cm2]

Other alpha emitters7 8.33 Bq/100 cm2 

(500 dpm/100 cm2)

25 Bq/100 cm2 

(1,500 dpm /100 cm2)

1.67 Bq/100 cm2 

(100 dpm/100 cm2)

Beta-gamma emitters 

(nuclides with decay 

modes other than

alpha emission or 

spontaneous 

fission) except Sr-90 

and others noted 

above.

83.3 Bq/100 cm2 

[5,000 dpm/100 cm2]

250 Bq/100 cm2 

[15,000 dpm/100 cm2]

16.7 Bq/100 cm2

[1,000 dpm/100 cm2]

1Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for 

alpha- and beta-gamma-emitting nuclides should apply independently.

2As used in this table, disintegrations per minute (dpm) means the rate of emission by radioactive material as 

determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and 

geometric factors associated with the instrumentation.

3Measurements of average contaminant should not be averaged over more than 1 square meter. For objects of 

less surface area, the average should be derived for each such object.

4The maximum contamination level applies to an area of not more than 100 centimeters squared (cm2).

5The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that

area with filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive 

material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects 

of less surface area is determined, the pertinent levels should be reduced proportionally and the entire surface 

should be wiped.

6The average and maximum radiation levels associated with surface contamination resulting from beta-gamma 

emitters should not exceed 0.2 mrad/h at 1 cm and 1.0 mrad/h at 1 cm, respectively, measured through not more 

than 7 milligrams per square centimeter of total absorber.

_________________________________

7Surface contamination levels derived using one order of magnitude less than the values for beta-gamma emitters.
M–5

Decommissioning Surveys for Release for Unrestricted Use

When a facility will be closed and released for unrestricted use, the values in Table M–3 provide 

acceptable residual contamination levels, known as “screening values,” for building surfaces.

To the extent practicable, facilities should be decontaminated to below these levels [as low as 

reasonably achievable (ALARA)]. Surveys should be conducted for both removable 

contamination (not to exceed 10 percent of the values in Table M–3) and for total residual 

contamination before the facilities or equipment are released from restricted to unrestricted use 

to ensure that they meet the applicable limits.

Units are disintegrations per minute per 100 square centimeters [dpm/100 cm2

]. One dpm is 

equivalent to 0.0167 Bq. The screening values represent surface concentrations of individual 

radionuclides that would be deemed in compliance with the 0.25 mSv [25 mrem] in a year 

unrestricted release dose limit in 10 CFR 20.1402, “Radiological criteria for unrestricted use.”

For radionuclides in a mixture, the “sum of fractions” rule applies; see 10 CFR Part 20, 

Appendix B, Note 4 for an example of the “sum of fractions” calculation. Refer to the 

NUREG–1757, “Consolidated Decommissioning Guidance,” for further information on 

application of the values in this table. 

Table M–3 was derived using the DandD screening code, Version 1 (DandD, v1.0) and its 

default input parameters. Table M–3 provides criteria that permit licensees to demonstrate 

compliance with the unrestricted release dose criterion in the License Termination Rule in 

Subpart E of 10 CFR Part 20. Sites with building surface contamination levels below those 

listed in Table M–3 would be deemed acceptable for release for unrestricted use, in accordance 

with the dose criteria in 10 CFR 20.1402, provided that residual radioactivity has been reduced 

to ALARA levels. The table is intended for use as criteria to facilitate license termination for 

many simple, routine decommissioning cases without a site-specific dose assessment. For 

facilities with contamination levels above those in Table M–3, additional site-specific dose 

assessments may be necessary, and licensees should refer to NUREG–1757 regarding 

acceptable methods for conducting the appropriate dose assessment, such as using the current 

version of DandD to develop site-specific screening criteria. The most recent version of the 

DandD code can be installed by downloading the self-extracting program file, setup.exe, 

accessed through the Web site at http://www.marssim.com/Dose_Modeling.htm. Links to other 

useful software and guidance documents are also found at that Web site.

Table M–3 does not include screening values for radionuclides that emit alpha particles or for 

soil contamination. Screening values for radionuclides not listed in the table may be found in 

“Supplemental Information on the Implementation of the Final Rule on Radiological Criteria for 

License Termination” (63 FR 64132; November 18, 1998) for building surfaces; “Supplemental 

Information on the Implementation of the Final Rule on Radiological Criteria for License 

Termination” (64 FR 68395; December 7, 1999) for soils; and “Use of Screening Values to 

Demonstrate Compliance With the Final Rule on Radiological Criteria for License Termination” 

(65 FR 37186; June 13, 2000), which references Tables 5.19 (surface contamination) and 

6.91 (surface soil) from NUREG/CR–5512, Vol. 3, “Residual Radioactive Contamination from 

Decommissioning, Parameter Analysis, Draft Report for Comment, October 1999.” Tables 5.19 

(surface contamination) and 6.91 (surface soil) are for use in determining acceptable screening 

values for radionuclides not listed in the first two Federal Register notices.
M–6

Table M–3. Screening Values for Building Surface Contamination*

Radionuclide Symbol Screening levels for unrestricted release (dpm/100 cm2)

Hydrogen-3 (Tritium) H-3 1.2 × 108

Carbon-14 C-14 3.7 × 106

Sodium-22 Na-22 9.5 × 103

Sulfur-35 S-35 1.3 × 107

Chlorine-36 Cl-36 5.0 × 105

Manganese-54 Mn-54 3.2 × 104

Iron-55 Fe-55 4.5 × 106

Cobalt-57 Co-57 2.1 × 105

Cobalt-60 Co-60 7.1 × 103

Nickel-63 Ni-63 1.8 × 106

Zinc-65 Zn-65 4.8 × 104

Strontium-90 Sr-90 8.7 × 103

Technetium-99 Tc-99 1.3 × 106

Iodine-129 I-129 3.5 × 104

Cesium-137 Cs-137 2.8 × 104

Europium-152 Eu-152 1.3 × 104

Tungsten-181 W-181 1.1 × 106

Iridium-192 Ir-192 7.4 × 104

*Screening levels are based on the assumption that the fraction of removable surface contamination is equal to 0.1.

For cases when the fraction of removable contamination is undetermined or higher than 0.1, users may assume, for 

screening purposes, that 100 percent of surface contamination is removable; and, therefore, the screening levels 

should be decreased by a factor of 10. Alternatively, users having site-specific data on the fraction of removable 

contamination (e.g., within 10 percent to 100 percent range) may calculate site-specific screening levels using the 

DandD, Version 1 computer code.

The type of surveys to be performed for decommissioning of facilities, and the number and 

locations of survey points or samples to be collected, should be determined using the 

guidance found in NUREG–1757. Most licensees will be able to use the “Simple Approaches 

for Conducting Final Radiological Surveys” found in Appendix B of NUREG–1757, Volume 2. 

If the decommissioning of facilities is too complex to use one of the “simple approaches,” then 

licensees may have to develop a more formal decommissioning plan.

Survey Record Requirements

Each survey record should include the following:

• a diagram of the area surveyed (see Figure M–1)

• a list of items and equipment surveyed

• specific locations on the survey diagram where wipe test was taken

• ambient radiation levels with appropriate units

• contamination levels with appropriate units

• make and model number of instruments used

• background levels

• name of the person making the evaluation and recording the results and date
M–7

Figure M–1. Laboratory Layout. This is an example of a laboratory survey map.

Licensees should record contamination levels observed and procedures followed for incidents 

involving contamination of individuals. The record should include names of individuals involved, 

description of work activities, calculated dose, probable causes (including root causes), 

steps taken to reduce future incidents of contamination, times and dates, and the 

surveyor’s signature. In addition, 10 CFR 30.35(g), 40.36(f), and 70.25(g) require, in part, that 

records of information important to the decommissioning of a facility, including records of spills 

or other unusual occurrences involving the spread of contamination in and around the facility, 

equipment, or site, must be maintained.

Air Monitoring in the Workplace

Air monitoring can be used to do the following:

• determine whether the confinement of radioactive materials is effective

• measure airborne radioactive material concentrations in the workplace

• estimate worker intakes of radioactive material

• determine posting requirements

• determine what protective equipment and measures are appropriate

• warn of significantly elevated levels of airborne radioactive materials

If bioassay measurements are used to determine worker doses of record, air sampling may be 

used to determine time of intake and to determine which workers should have bioassay 

measurements. The use of engineering controls and a good air sampling program may 

eliminate the need for bioassays.
M–8

Refer to Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” dated June 1992 

and NUREG–1400, “Air Sampling in the Workplace,” dated September 1993, which are

available in the NRC Agencywide Documents Access and Management System (ADAMS) at 

Accession Nos. ML003739616 and ML13051A671, respectively, for further guidance on 

air sampling.

Airborne Effluent Release Monitoring

When practicable, airborne radioactive effluents should be released from monitored release 

points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to 

estimate public exposure. Licensees should verify the performance of effluent monitoring 

systems by regular calibration (at least annually) to ensure their reliability. 

Regulatory Guide 4-20, Revision 1, “Constraint on Releases of Airborne Radioactive Materials 

to the Environment for Licensees Other than Power Reactors,” dated April 2012, provides 

guidance on methods (calculation or COMPLY code) acceptable to the NRC for compliance with 

the constraint on air emissions to the environment.

Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” dated July 1993, 

provides guidance on designing an acceptable program for establishing and maintaining ALARA 

levels for gaseous and liquid effluents at materials facilities.

For release points where monitoring is not practicable, the licensee should estimate the 

magnitude of the unmonitored effluents. These unmonitored releases will occur any time 

unsealed material is handled outside a fume hood or other device that will control the releases. 

The licensee should include these estimates when demonstrating compliance with dose limits 

and ALARA goals. Unmonitored releases may be estimated based on the quantity of material 

used in these areas, the number of procedures performed, or other appropriate methods. The 

unmonitored effluents should not exceed 30 percent of the total estimated effluent releases or 

10 percent of the permissible air effluent concentrations found on column 1 of Table 2 in 

10 CFR Part 20, Appendix B, whichever is greater.

Effluent monitoring systems should be designed in accordance with ANSI N13.1 (2011), 

“Sampling and Monitoring Releases of Airborne Radioactive Substances From The Stacks and 

Ducts of Nuclear Facilities,” and ANSI N42.18 (2004), “Specification and Performance of On-site 

Instrumentation for Continuously Monitoring Radioactivity in Effluents.”

Liquid Effluent Release Monitoring

The licensee must evaluate the concentrations of radioactive material in water that is 

released to the environment and to the sanitary sewer. These releases must meet the limits 

in 10 CFR 20.1302 and 20.2003, respectively.

The topic of sanitary sewerage releases is more fully discussed in Section 8.11 and Appendix P

of this NUREG.
M–9

Bioassay Monitoring

Frequency of Required Bioassay Measurements

Determining the appropriate frequency of routine bioassay measurements depends on the 

exposure potential and the physical and chemical characteristics of the radioactive material and 

the route of entry to the body. The licensee should consider the following elements when 

determining the frequency of routine bioassay measurements:

• potential exposure of the individual

• retention and excretion characteristics of the radionuclides

• sensitivity of the measurement technique

• acceptable uncertainty in the estimate of intake and committed dose equivalent

Bioassay measurements used for demonstrating compliance with the occupational dose limits 

should be conducted often enough to identify and quantify potential exposures and resultant 

intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10 percent

ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes 

and assess occupational doses for exposed individuals who are likely to exceed 10 percent of 

the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults).

Separate categories of bioassay measurements, routine bioassay measurements, and special

bioassay measurements further determine the frequency and scope of measurements.

Routine Bioassay Measurements

Routine bioassay measurements include baseline measurements, periodic measurements, and 

termination measurements. These measurements should be conducted to confirm that 

appropriate controls exist and to assess dose. The method of bioassay selected (e.g., whole

body counting, urinalysis, etc.) and the samples collected will vary according to the radionuclide 

and the compound to which it is attached. Sample collection procedures should be developed 

to ensure that appropriate types, sizes, and numbers of samples are collected that will provide 

appropriate physiological information for the dose assessment.

An individual’s baseline measurement of radioactive material within the body should be 

conducted before beginning work that involves exposure to radiation or radioactive materials for 

which monitoring is required.

In addition to the baseline measurements, periodic bioassay measurements should be 

performed. The frequency of periodic measurements should be based on the likelihood of 

significant exposure of the individual. In determining the worker’s likely exposure, consider such 

information as the worker’s access, work practices, measured levels of airborne radioactive 

material, and exposure time. Periodic measurements should be made when the cumulative 

exposure to airborne radioactivity since the most recent bioassay measurement is > 0.02 ALI 

(40 derived air concentration (DAC) hours). Noble gases and airborne particulates with a 

radioactive half-life of less than 2 hours should be excluded from the evaluation, since external 

exposure generally is the predominate exposure pathway.

At a minimum, periodic measurements should be conducted annually. Periodic measurements 

provide additional information on any long-term accumulation and retention of radioactive 
M–10

material in the body, especially for exposures to concentrations of airborne radioactive material 

below monitoring thresholds.

When an individual is no longer subject to the bioassay program, because of change in 

employment status, termination bioassay measurement should be made, when practicable, to 

ensure that any unknown intakes are quantified.

Special Bioassay Monitoring

Because of uncertainty in the time of intakes and the absence of other data related to the 

exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to 

actual intakes for routine measurements can sometimes be difficult. Abnormal and inadvertent 

intakes from situations such as a failed respiratory protective device, inadequate engineering 

controls, inadvertent ingestion, contamination of a wound, or skin absorption, should be 

evaluated on a case-by-case basis. When determining whether potential intakes should be 

evaluated, consider the following circumstances:

• the presence of unusually high levels of facial or nasal contamination

• entry into airborne radioactivity areas without appropriate exposure controls

• operational events with a reasonable likelihood that a worker was exposed to unknown 

quantities of airborne radioactive material (e.g., loss of system or container integrity)

• known or suspected incidents of a worker ingesting radioactive material

• incidents that result in contamination of wounds or other skin absorption

• evidence of damage to or failure of a respiratory protective device

• elevated air monitoring results

References: 

• Regulatory Guide 4.20, Revision 1, “Constraints on Releases of Airborne Radioactive 

Materials to the Environment for Licensees Other than Power Reactors,” April 2012

• Regulatory Guide 8.9, Revision 1, “Acceptable Concepts, Models, Equations, and 

Assumptions for a Bioassay Program,” July 1993

• Regulatory Guide 8.20, Revision 2, “Applications of Bioassay for Radioiodine,” 

September 2014, ADAMS Accession No. ML14064A060

• Regulatory Guide 8.23, Revision 1, “Radiation Safety Surveys at Medical Institutions,” 

January 1981

• Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” June 1992

• Regulatory Guide 8.32, “Criteria for Establishing a Tritium Bioassay Program,” July 1988
M–11

• Regulatory Guide 8.34, “Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses,” July 1992

• Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” July 1993

• NUREG–1400, “Air Sampling in the Workplace,” September 1993

• NUREG–1549, Draft Report for Comment, “Decision Methods for Dose Assessment 

to Comply with Radiological Criteria for License Termination,” July 1998, 

ADAMS Accession No. ML993250291

• NUREG–1575, “Multi-Agency Radiation Survey and Site Investigation Manual 

(MARSSIM),” Revision 1, August 2000

• NUREG–1575, Supplement 1, “Multi-Agency Radiation Survey and Assessment of 

Materials and Equipment Manual (MARSAME),” January 2009

• NUREG–1757, “Consolidated Decommissioning Guidance,”

— Volume 1, Decommissioning Process for Materials Licensees (Revision 2), 

September 2006

— Volume 2, Characterization, Survey, and Determination of Radiological Criteria 

(Revision 1), September 2006

• NUREG/CR-4884, “Interpretation of Bioassay Measurements,” July 1987

• NUREG/CR-5512, Volume 2, “Residual Radioactive Contamination from 

Decommissioning: User’s Manual DandD Version 2.1,” April 2001,

ADAMS Accession No. ML010940257

• NUREG/CR–5512, Volume 3, “Residual Radioactive Contamination from 

Decommissioning: Parameter Analysis, Draft Report for Comment,” October 1999 

[containing Tables 5.19 (surface contamination) and 6.91 (surface soil)], 

ADAMS Accession No. ML082460902

• Federal Register: “Supplemental Information on the Implementation of the Final Rule on 

Radiological Criteria for License Termination,” 63 FR 67132-34, November 18, 1998

• Federal Register: “Supplemental Information on the Implementation of the Final Rule on 

Radiological Criteria for License Termination,” 64 FR 68395–96, December 7, 1999

• Federal Register: “Use of Screening Values to Demonstrate Compliance With the Final 

Rule on Radiological Criteria for License Termination,” 65 FR 37186, June 13, 2000

• ANSI N13.1-2011, “Sampling and Monitoring Releases of Airborne Radioactive 

Substances from the Stacks and Ducts of Nuclear Facilities,” 2011

• ANSI N13.30-2011, “Performance Criteria for Radiobioassay,” 2011
M–12

• ANSI N42.18-2004, “Specification and Performance of On-site Instrumentation for 

Continuously Monitoring Radioactivity in Effluents,” 2004

• NCRP Commentary No. 3, “Screening Techniques for Determining Compliance with 

Environmental Standards–Releases of Radionuclides to the Atmosphere,” published in 

January 1989, and the addendum published in October 1989

• U.S. Department of Energy, DOE G 441.1-1C, Admin Chg 1, “Radiation Protection 

Programs Guide for Use with Title 10, Code of Federal Regulations, Part 835, 

Occupational Radiation Protection,” July 8, 2011
APPENDIX N

MODEL LEAK TEST PROGRAM

N–1

Model Leak Test Program

Training

Before allowing an individual to perform leak testing, the licensee must ensure that he or she 

has sufficient classroom and on-the-job training to show competency in performing leak testing 

and sample analysis independently.

Classroom training may be in the form of lecture, online, video, hands-on, or self-study and 

should cover the following subject areas:

• principles and practices of radiation protection

• radioactivity measurements, monitoring techniques, and instrument use

• mathematics and calculations used for measuring radioactivity

• biological effects of radiation

Appropriate on-the-job training consists of the following:

• observing authorized personnel collecting and analyzing leak test samples

• collecting and analyzing leak test samples under the supervision and in the physical 

presence of an individual authorized to perform leak testing and sample analysis

Facilities and Equipment

• To ensure achieving the required sensitivity of measurements, analyze leak tests in a 

low-background area.

• Use a calibrated and operable survey instrument to check leak test samples for gross 

contamination before they are analyzed.

• Analyze the leak test sample using an instrument that is appropriate for the type of 

radiation to be measured (e.g., NaI(Tl) well-counter system for gamma emitters, liquid 

scintillation for beta emitters, and gas-flow proportional counter for alpha emitters).

• If the sensitivity of the counting system is unknown, determine the minimum detectable 

activity (MDA). The MDA may be determined using the following formula:

MDA = 

2.71 + 4.65 �bkg ×t

t ×E

where: MDA = minimum detectable activity in disintegrations per minute (dpm)

bkg = background count rate in counts per minute (cpm)

t = background counting time in minutes

E = detector efficiency in counts per disintegration

For example:

where: bkg = 200 cpm

E = 0.1 counts per disintegration (10 percent efficient)

t = 2 minutes
N–2

MDA = 

2.71 + 4.65 �200 cpm × 2 minutes

2 × 0.1 = 

2.71 + 4.65 √400

0.2

= 

2.71 + 4.65(20)

0.2 = 

2.71 + 93

0.2 = 

95.71

0.2

= 

478.55 disintegrations

minute

becquerels (Bq) = 

1 disintegration

second

MDA = 

478.55 disintegration

minutes × 

minute

60 seconds = 7.976 Bq

Note: The MDA equation shown assumes that counting times for the background measurement 

and for the sample will be equal. MDA equations for nonequal counting times, as well as 

derivations of equations and discussions of limitations, can be found in “Decommissioning 

Health Physics—A Handbook for MARSSIM Users,” Eric W. Abelquist, published by 

Taylor & Francis Group, 2001.

Frequency for Conducting Leak Tests of Sealed Sources

Leak tests will be conducted at the frequency specified in the respective Sealed Source and 

Device registration certificate. If a sealed source is not registered, leak tests should be 

conducted at 6 month intervals, unless a different interval is established during the licensing 

process. Leak testing of sealed sources may be required by license condition.

Procedure for Performing Leak Testing and Analysis

• For each sealed source to be tested, list identifying information such as the sealed 

source serial number, manufacturer, model number, radionuclides, and activity of the 

sealed source.

• Use a radiation survey meter to monitor exposure.

• Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source.

• Number each wipe to correlate with identifying information for each source.

• Wipe the most accessible area where contamination would accumulate if the sealed 

source were leaking, but do not wipe the surface of a plated or foil source

(see manufacturer’s instructions).

• Select instrumentation that is sensitive enough to detect 185 becquerels (Bq) 

(0.005 microcurie) of the radionuclide contained in the sealed source.

• Using the selected instrument, count, and record background count rate.

• Check the counting efficiency of the instrument using a standard source of the same 

radionuclide as the source being tested or one with similar energy characteristics. The 
N–3

calibration source should be in the same configuration as the sample. Accuracy of 

standards should be within plus or minus 5 percent of the stated value and traceable to 

primary radiation standards such as those maintained by the National Institute of 

Standards and Technology.

• Calculate the counting efficiency of the detector. 

Efficiency in cpm/Bq = [(cpm from std) – (cpm from bkg)]

activity of std in Bq

where: cpm = counts per minute

std = standard 

bkg = background

Bq = becquerel

• Count each wipe sample; determine net count rate.

• For each sample, calculate and record estimated activity in becquerels (or microcuries). 

The activity of the sample in becquerels may be calculated using the following formula:

Activity of sample [Bq] = [(cpm from wipe sample) - (cpm from bkg)]

efficiency in cpm/Bq

• Sign and date the list of sources, data, and calculations. Retain records for 3 years 

[under Title 10 of the Code of Federal Regulations (10 CFR) 20.2103(a)].

• If the wipe test activity is 185 becquerels (0.005 microcuries) or greater, notify the 

radiation safety officer so that the source can be withdrawn from use and disposed of 

properly. Also, notify the U.S. Nuclear Regulatory Commission.

APPENDIX O

U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS

O–1

U.S. Department of Transportation Regulations

Note: The following list of U.S. Department of Transportation (DOT) regulations is provided to 

inform licensees about typical requirements that apply to the transportation of licensed material 

including the preparation of shipments of licensed material. Licensees should note that the list 

is incomplete in that not all potentially applicable requirements have been included. Also, 

transportation requirements change; therefore, licensees should consult the regulations for 

definitive information about current requirements. Additional information on transportation 

requirements may be found at the DOT Web site: https://www.dot.gov/.

Title 10 of the Code of Federal Regulations (10 CFR) 71.5 requires compliance with DOT 

regulations in 49 CFR Parts 107, 171 through 180 and 390 through 397, appropriate to the 

mode of transport. The following are the major areas in DOT regulations most relevant for 

transporting radioactive materials as Type A or Type B quantities:

• Table of Hazardous Materials and Special Provisions—49 CFR 172, Subpart B

— 49 CFR 172.101—Hazardous Materials Table [proper shipping name, hazard 

class, identification number]

— 49 CFR 172.101—List of Hazardous Substances and Reportable Quantities, 

Table 2 to Appendix A—Radionuclides

• Shipping Papers—49 CFR 172, Subpart C

— 49 CFR 172.201—Preparation and retention of shipping papers

— 49 CFR 172.202—Description of hazardous material on shipping papers

— 49 CFR 172.203—Additional description requirements

— 49 CFR 172.204—Shipper’s certification 

• Marking—49 CFR 172, Subpart D

— 49 CFR 172.300—Applicability

— 49 CFR 172.301—General marking requirements for non-bulk packagings

— 49 CFR 172.304—Marking requirements

— 49 CFR 172.310—Class 7 (radioactive) materials

— 49 CFR 172.324—Hazardous substances in non-bulk packagings [designation of 

“reportable quantities” with the letters “RQ”]

• Labeling—49 CFR 172, Subpart E

— 49 CFR 172.400—General labeling requirements

— 49 CFR 172.400a—Exceptions from labeling

— 49 CFR 172.401—Prohibited labeling

— 49 CFR 172.403—Class 7 (radioactive) material

— 49 CFR 172.406—Placement of labels

— 49 CFR 172.436—RADIOACTIVE WHITE-I label

— 49 CFR 172.438—RADIOACTIVE YELLOW-II label

— 49 CFR 172.440—RADIOACTIVE YELLOW-III label
O–2

• Placarding—49 CFR 172, Subpart F

— 49 CFR 172.500—Applicability of placarding requirements

— 49 CFR 172.504—General placarding requirements

— 49 CFR 172.516—Visibility and display of placards

— 49 CFR 172.556—RADIOACTIVE placard

• Emergency Response Information—49 CFR 172, Subpart G

— 49 CFR 172.600—Applicability and general requirements

— 49 CFR 172.602—Emergency response information

— 49 CFR 172.604—Emergency response telephone number

• Training—49 CFR 172, Subpart H

— 49 CFR 172.702—Applicability and responsibility for training and testing

— 49 CFR 172.704—Training requirements

• Safety and Security Plans—49 CFR 172, Subpart I

— 49 CFR 172.800—Purpose and applicability

— 49 CFR 172.802—Components of a security plan

• Shippers—General Requirements for Shipments and Packagings—49 CFR Part 173

— 49 CFR 173.25—Authorized packagings and overpacks

— 49 CFR 173.403—Definitions

— 49 CFR 173.411—Industrial packages

— 49 CFR 173.412—Additional design requirements for Type A packages

— 49 CFR 173.413—Requirements for Type B packages

— 49 CFR 173.415—Authorized Type A packages

— 49 CFR 173.416—Authorized Type B packages

— 49 CFR 173.433—Requirements for determining basic radionuclide values, and 

for the listing of radionuclides on shipping papers and labels

— 49 CFR 173.435—Table of A1 and A2 values for radionuclides

— 49 CFR 173.441—Radiation level limitations and exclusive use provisions

— 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory Commission 

approved packages

— 49 CFR 173.475—Quality control requirements prior to each shipment of Class 7 

(radioactive) materials

— 49 CFR 173.476—Approval of special form Class 7 (radioactive) materials

• Carriage by Public Highway—49 CFR Part 177

— 49 CFR 177.817—Shipping papers

— 49 CFR 177.842—Class 7 (radioactive) material [includes requirement for 

blocking and bracing during transport]

Note: The following reference charts are for reference only and are not a substitute for DOT

and U.S. Nuclear Regulatory Commission transportation regulations.
O–3

1. Minimum Required Packaging for Class 7 (Radioactive) Material:[1] (49 CFR 173 and 10 CFR 71)[2]

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

Minimum Packaging Required for Radioactive Materials other than Low Specific Activity (LSA) Material and Surface 

Contaminated Objects (SCO) based on Activity of Package Contents

Radioactive Material Quantity[3] Limited Quantities and 

Articles Type A[4] [9] Type B 

Activity Restrictions ≤ the limits specified in

Table 4 of § 173.425

≤ A1 for special form

≤ A2 for normal form

> A1 for special form

> A2 for normal form

Contents of 

Package

Non-fissile and 

Fissile Excepted Excepted Package Type A Package Type B(U) or Type B(M) package

Fissile N/A Type AF[10] package Type B(U)F or Type B(M)F package

Minimum Packaging Required for LSA Material and SCO[5,6]

Type(s) of LSA 

and/or SCO LSA-I LSA-II LSA-III SCO-I SCO-II

Category of 

Package for 

Domestic or 

International 

Transport[7,8]

Unpackaged[8] - - Unpackaged[8] -

IP-1: solids or liquids/exclusive use - - IP-1 -

IP-2: liquids/non-exclusive use IP-2: exclusive use[9] IP-2: exclusive use - IP-2

Specification tank cars or cargo tank 

motor vehicles: liquids/exclusive use

IP-3: liquids or 

gases/non-exclusive 

use[9]

IP-3: non-exclusive 

use - -

Alternative 

Provisions for 

Domestic only 

Transport[8]

Packaging shall meet the requirements of §§ 173.24, 24a, and 173.410.

Transportation shall be an exclusive use shipment.

Activity per shipment must be less than an A2 quantity (see § 173.427(b)(4)).

[1] Additional provisions may apply for radioactive materials that are pyrophoric, oxidizing, fissile excepted, or uranium hexafluoride. 

[2] Each NRC licensee shall comply with the applicable requirements of the DOT regulations in 49 CFR parts 107, 171 through 180, 

and 390 through 397 (see § 71.5).

[3] Materials that contain radionuclides, where both the activity concentration and the total activity in the consignment exceed either the 

values specified in the table in § 173.436 or the values derived according to the instructions in § 173.433, must be regulated in 

transport as Class 7 (radioactive) material. 

[4] Except for LSA material and SCO, a Type A package may not contain a quantity of Class 7 (radioactive) material greater than A1 or 

A2 (see § 173.431(a)). See A1 and A2 definitions in § 173.403.

[5] The external dose rate from LSA material or SCO in a single package may not exceed 10 mSv/h (1 rem/h) at 3 meters from the 

unshielded material or objects (see §§ 173.427(a)(1) and (d)). 

[6] LSA material and SCOs that are or contain fissile material in quantities that are not fissile excepted must be packaged in appropriate 

Type AF or Type BF packages, and not classified as LSA material or SCO. For alternate domestic transport provisions, see 

§ 173.427(b)(4). For comprehensive guidance on packaging and transportation of LSA material and SCO, see NUREG-1608.

[7] For the quantity of LSA material and SCO transported in a single conveyance, see the limits specified in § 173.427(a)(2).

[8] LSA material or SCO shall be appropriately packaged in accordance with § 173.427(b) or (d). Certain LSA-I material and SCO-I may 

be transported unpackaged under the conditions in § 173.427(c).

[9] See §§ 173.411(c) and 173.415(a) for requirements related to package record retention (2 years) and associated documentation of 

physical tests. 

[10] See §§ 71.22(a), 71.23(a) and 173.417(a) for regulations regarding the use of non-AF packages for fissile materials. 
O–4

2. Radiation Level, TI and CSI Limits for Transportation by Mode:[1] (49 CFR 173 - 177, and 10 CFR 71)[10]

Type of Transport Non-exclusive Use Exclusive Use

Mode of Transport Road, Rail, Vessel and Air[9] Road and Rail Vessel Air (cargo 

only)

Radiation Level Limits[2]

Package Surface 2 mSv/h (200 mrem/h)

2 mSv/h (200 mrem/h): other than 

closed vehicles

10 mSv/h (1000 mrem/h): closed 

vehicles

2 mSv/h[11]

(200 mrem/h)

2 mSv/h 

(200 mrem/h)[3]

Conveyance[4] N/A

2 mSv/h (200 mrem/h): outer 

surfaces (sides, top and underside) 

of vehicle[5]

N/A N/A

0.1 mSv/h (10 mrem/h): at any 

point two (2) m (6.6 ft) from sides 

of the vehicle[5]

N/A N/A

Occupied position N/A 0.02 mSv/h (2 mrem/h): in any 

normally occupied area[6]

Requirements 

of 

§ 176.708 apply

N/A

Transport Index (TI) Limits[2]

Package[7]

3: passenger aircraft

10: road, rail, vessels and cargo 

aircraft

No limit 10

Conveyance[4]

50: road, rail and passenger aircraft

50 to No limit: vessels[8]

200: cargo aircraft

No limit 200

Overpack

N/A: for road, rail

50 to 200: vessel[8]

3: passenger aircraft; 

10: cargo aircraft

N/A No limit[8] N/A

Criticality Safety Index (CSI) Limit for Fissile Material[2]

Package[7] 50 100 100 100

Conveyance[4]

50: road, rail and air

50: for holds, compartments or 

defined deck areas of vessels[8]

200 to No limit: for a total vessel[8]

100

200 to No limit: 

for a total 

vessel[8]

100

Overpack 50: road, rail, vessels[8] and air N/A

[1] Radiation level, TI, and CSI are defined in § 173.403.

[2] In addition to any applicable radiation level, TI and CSI limits, separation distance requirements apply to packages, conveyances, freight 

containers and overpacks; to occupied positions; and to materials stored in transit. Separation distances are based on the sum of the TIs and, 

for fissile materials, the sum of the CSIs. [see applicable 49 CFR references for: Rail - § 174.700; Air – §§ 175.700 through 175.703; Vessel -

§§ 176.700 through 176.708; and Highway - § 177.842].

[3] Higher package surface radiation levels may be allowed through an approved special arrangement.

[4] Conveyance is, for transport by public highway or rail, any transport vehicle or large freight container; and for transport by air, any aircraft. See 

definitions in § 173.403.

[5] The outer surfaces (sides, top and underside) of vehicles are specified for road and rail vehicles in § 173.441.

[6] For rail, normally occupied areas include the transport vehicle and adjacent rail cars. The 0.02 mSv/h (2 mrem/h) limit does not apply to carriers 

operating under a State or federally regulated radiation protection program where personnel wear radiation dosimetry devices.

[7] Additional TI and CSI limits apply for individual packages when non-fissile radioactive material packages are mixed with fissile material 

packages (see § 173.459).

[8] For details on TI and CSI limits for transport by vessel, see § 176.708.

[9] Only excepted packages and packages intended for use in research, medical diagnosis, and treatment are permitted on passenger aircraft (see 

§§ 173.448(f) and 175.700).

[10] The limits in this table do not apply to excepted packages. See the following references for the radiation level limits for: limited quantities, § 

173.421; instruments and articles, § 173.424; articles containing natural uranium or thorium, § 173.426; or empty packaging, § 173.428.

[11] 2 mSv/h (200 mrem/h) other than intermodal transport of closed transport vehicles or exclusive use vessel.
O–5

 3. Contamination Limits and Quality Control for Class 7 (Radioactive) Materials:

(49 CFR 173.443 and 173.475, and 10 CFR 71)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

Maximum Permissible Limits for Non-fixed Radioactive Contamination on Packages When Offered for Transport

The level of non-fixed (removable) radioactive contamination on the external surface of each package, conveyance, freight container, and overpack offered for 

transport must be kept as low as reasonably achievable, and shall not exceed the values shown in the following table: 

Contaminant 

Maximum permissible limits (§ 173.443(a), Table 9)

Bq/cm2 μCi/cm2 dpm/cm2

Beta and gamma emitters and low toxicity alpha emitters 4 10-4 240

All other alpha emitting radionuclides 0.4 10-5 24

The non-fixed contamination shall be determined by:

(a) wiping, with an absorbent material using moderate pressure, sufficient areas on the package to obtain a representative sampling of the non-fixed 

contamination;

(b) ensuring each wipe area is 300 cm2 in size;

(c) measuring the activity on each single wiping material and dividing that value by the surface area wiped and the efficiency of the wipe procedure, where 

an actual wipe efficiency may be used, or it may be assumed to be 0.10.

Alternatively, the contamination level may be determined using alternative methods of equal or greater efficiency.

A conveyance used for non-exclusive use shipments is not required to be surveyed unless there is reason to suspect that it exhibits contamination (see 

§ 173.443(a)(2)).

Provisions for Control of Contamination on Radioactive Material Packages Offered for Transport and at the Time of Receipt

• When offered for transport, the non-fixed contamination on each package of radioactive material must be kept as low as reasonably achievable and may 

not exceed the limits set forth in § 173.443(a), Table 9 (as shown above).

• During transport, non-fixed contamination levels on packages transported as exclusive use by rail or highway may not exceed 10 times the limits in 

§ 173.443(a), Table 9 (as shown above).

Provisions for Non-fixed (Removable) Contamination on Excepted and Empty Radioactive Material Packages

• The non-fixed radioactive surface contamination on the external surface of excepted and empty packages shall not exceed the limits specified in 

§ 173.443(a), Table 9 (as shown above).

• The internal contamination of an empty package must not exceed 100 times the limits in § 173.443(a), Table 9 (as shown above).

Provisions for Non-fixed (Removable) Contamination on Packages and in Rail and Road Vehicles 

used for Exclusive Use Shipments of Radioactive Material

• The levels of non-fixed radioactive contamination on the packages (a) at the beginning of transport, may not exceed the levels prescribed in the above 

table, and (b) at any time during transport, may not exceed ten times the levels prescribed in § 173.443(a), Table 9 (as shown above) [see § 173.443(b)].

• Each conveyance, overpack, freight container, or tank used for transporting Class 7 (radioactive) material as an exclusive use shipment that utilizes the 

provisions of § 173.443(b) must be surveyed with appropriate radiation detection instruments after each exclusive use transport. If contamination values 

exceed acceptable levels, the transport vehicle may not be returned to exclusive use transport service, and then only for subsequent exclusive use 

shipment, unless the radiation dose rate at each accessible surface is demonstrated to be 0.005 mSv/h (0.5 mrem/h) or less, and that there is no 

significant non-fixed radioactive surface contamination as specified in § 173.443(a), Table 9 (as shown above) [see § 173.443(c)].

Provisions for Non-fixed (Removable) Contamination in Closed Rail and Road Vehicles

that are used Solely for the Transportation of Radioactive Material (§ 173.443(d))

• The contamination levels must not exceed 10 times the levels prescribed in § 173.443(a), Table 9 (as shown above).

• Each vehicle is marked with the words “For Radioactive Materials Use Only” in letters at least 76 mm (3 in) high in a conspicuous place on both sides of 

the exterior of the vehicle.

• The vehicle must meet the placard requirements of Subpart F of Part 172.

• A survey of the interior surfaces of the empty closed vehicle must show that the radiation dose rate at any point does not exceed 0.1 mSv/h (10 mrem/h) at 

the surface or 0.02 mSv/h (2 mrem/h) at 1 m (3.3 feet) from the surfaces.

• Each vehicle shall be kept closed except for loading or unloading.

Provisions for Quality Control Prior to Each Shipment of Radioactive Material (§ 173.475)

• Before each shipment of any radioactive materials package, the offeror must ensure, by examination or appropriate tests, that:

(a) the packaging is proper for the contents to be shipped; 

(b) the packaging is in unimpaired physical condition, except for superficial marks; 

(c) each closure device of the packaging, including any required gasket, is properly installed, secured, and free of defects; 

(d) for fissile material, each moderator and neutron absorber, if required, is present and in proper condition; 

(e) each special instruction for filling, closing, and preparation of the packaging for shipment has been followed; 

(f) each closure, valve, or other opening of the containment system is properly closed and sealed; 

(g) each packaging containing liquid in excess of an A2 quantity and intended for air shipment has been tested to show that it will not leak under an 

ambient atmospheric pressure of not more than 25 kPa, absolute (3.6 psia), where the test must be conducted on the entire containment system, or 

on any receptacle or vessel within the containment system, to determine compliance with this requirement;

(h) the internal pressure of the containment system will not exceed the design pressure during transportation; and

(i) the external radiation and contamination levels are within the allowable limits specified in §§ 173.441 and 173.443.
O–6

4. Hazard Communications for Class 7 (Radioactive) Materials: Shipping Papers (49 CFR 172, Subpart C)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information. [1]

Shipping Paper Entries

Always Required Sometimes Required Optional Entries

Basic description (in sequence):

• UN Identification number

• Proper Shipping Name

• Hazard Class (7)

• Maximum activity contained in each 

package in SI units (e.g., Bq, TBq), 

or in both SI and customary units 

(e.g., Ci, mCi) with customary units in 

parentheses following the SI units

• Number and type of packages 

Additional description:

• Name of each radionuclide[2]

• Description of physical and 

chemical form (unless special form)

• “Special form” when not in the 

proper shipping name

• Category of label used

• Transport index (TI) of each package 

bearing a Yellow-II or Yellow-III label

Additional entry requirements:

• 24 hour emergency telephone 

number

• Shipper’s Certification shall be 

provided by each person offering 

radioactive material for 

transportation[3]

• Proper page numbering (e.g., Page 1 

of 4)

Materials-based Requirements:

• The criticality safety index (CSI) or “Fissile Excepted” for 

fissile material

• “Highway route controlled quantity” or “HRCQ” for highway 

route controlled quantities

• The letters “RQ” entered either before or after the basic 

description for each hazardous substance [see § 171.8]

• Enter applicable subsidiary hazard class(es) in parentheses 

immediately following the primary hazard class when a 

subsidiary hazard label is required

• A hazardous waste manifest and the word “Waste” 

preceding the proper shipping name is required for 

radioactive material that is hazardous waste

Package-based Requirements:

• The applicable DOE or NRC package approval identification 

marking for each Type B(U), Type B(M), or fissile material 

package

• The International Atomic Energy Agency (IAEA) Certificate of 

Competent Authority identification marking for export 

shipment or shipment in a foreign made package

Shipment- and Administrative-based Requirements:

• Specify “exclusive use shipment” as required

• Specify instructions for maintaining exclusive use controls for 

shipments of LSA material or SCO under exclusive use

• Specify the notation “DOT–SP” followed by the special 

permit number for a special permit shipment

• The weight in grams or 

kilograms may be 

inserted instead of 

activity units for fissile 

radionuclides, except for 

Pu-239 and Pu-241

• The weight in grams of 

Pu-239 and Pu-241 may 

be inserted in addition to 

the activity units

• Other information is 

permitted provided it 

does not confuse or 

detract from the proper 

shipping name or other 

required information

Special Considerations/Exceptions for Shipping Papers

• For shipments of multiple cargo types, any HAZMAT entries must appear as the first entries on the shipping papers, or be entered in a 

color that readily contrasts with any description on the shipping papers or highlighted on the shipping papers in a contrasting color, or be 

designated by an “X” (or “RQ” if appropriate).

• Emergency response information consistent with §§ 172.600 – 172.606 shall be readily available on the transport vehicle.

• Shipments of excepted radioactive material in excepted packages, under UN2908, UN2909, UN2910, and UN2911, are excepted from 

shipping paper requirements if (a) the material is not a hazardous substance or hazardous waste and (b) the package does not contain 

fissile material or contain fissile material that is excepted by § 173.453.

• For road transport, the shipping papers shall be (a) readily available to authorities in the event of accident or inspection, (b) stored within 

the driver’s immediate reach while he is restrained by the lap belt, (c) readily visible to a person entering the driver's compartment or in a 

holder which is mounted to the inside of the door on the driver's side of the vehicle, and (d) either in a holder mounted to the inside of the 

door on the driver's side of the vehicle or on the driver's seat [see § 177.817(e)].

[1] International Atomic Energy Agency (IAEA); International Air Transportation Association (IATA); International Civil Aviation 

Organization (ICAO); International Maritime Organization (IMO). 

[2] For mixtures of radionuclides, the radionuclides to be shown must be determined in accordance with § 173.433(g), which is commonly 

known as the 95% rule; abbreviations (symbols) are authorized.

[3] The Shipper’s certification shall satisfy the requirements of § 172.204.
O–7

5. Hazard Communication for Class 7 (Radioactive) Materials: Marking of Packages: 

(49 CFR 172, Subpart D; and 49 CFR 173.471, 178.3 and 178.350)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information.

Markings on Packages

Markings Always Required 

Unless Excepted[1] Additional Markings Sometimes Required Optional Markings

For Non-bulk Packages:

• Proper shipping name

• Identification number 

(preceded by “UN” or “NA,” as 

appropriate) 

• Name and address of 

consignor or consignee, unless 

the package is:

 highway only and no motor 

carrier transfers; or

 part of a rail carload or 

truckload lot or freight 

container load, and entire 

contents of railcar, truck, or 

freight container are shipped 

from one consignor to one 

consignee

For Bulk Packages:

• Identification number on 

orange panel or white squareon-point display [see 

§§ 172.332 or 172.336]: 

 on each side and each end, 

if the packaging has a 

capacity of 3,785 L 

(1,000 gallons) or more[2], or

 on two opposing sides, if the 

packaging has a capacity of 

less than 3,785 L 

(1,000 gallons)[2]

Package-based marking requirements:

• Gross mass, including the unit of measurement (which may be 

abbreviated) for each package with gross mass greater than 50 kg 

(110 lb)

• Package type as appropriate, i.e., “TYPE IP–1,” “TYPE 

IP–2,” “TYPE IP–3,” “TYPE A,” “TYPE B(U)” or “TYPE B(M)”[1]

• Marked with international vehicle registration code of country of origin 

for IP–1, IP–2, IP–3 or Type A package design (e.g., “USA”)

• Both the name and 

address of consignor 

and consignee is 

recommended.

• Other markings on 

packages such as 

advertising are 

permitted, but must be 

located away from 

required markings and 

labeling.

For marking exceptions for 

LSA material and SCO, 

[see 

§ 173.427(a)(6)(vi)] 

(e.g., RADIOACTIVE-LSA, 

RADIOACTIVE-SCO, or 

RQ, as appropriate).

For an overpack, the 

marking “OVERPACK” in 

lettering 12 mm 

(0.5 inches) high. This 

marking is not required if 

the package type 

contained in the overpack 

is visible from the outside

[see § 173.25].

• Radiation (trefoil) symbol[3] on outside of outermost 

receptacle of each Type B(U) or Type B(M) 

packaging design

• Each NRC-approved package (e.g., Type AF, Type B(U), Type B(M), 

Type B(U)F, and Type B(M)F) must be marked with the identification 

marking indicated in the package approval

• For Specification 7A packaging, mark on the outside with “USA DOT 7A 

Type A”, and the name and address or symbol of the manufacturer 

satisfying §§ 178.3 and 178.350

Materials-based requirements:

• For a non-bulk IP–1 package containing a liquid, use 

underlined double arrow symbol indicating upright 

orientation[4]

, where the symbol is placed on two 

opposite sides of the packaging [see § 172.312]

• For a non-bulk package containing a hazardous substance, mark the 

outside of each package with the letters “RQ” in association with the 

proper shipping name

Administrative-based requirements:

• For each Type B(U), Type B(M) or fissile material package destined for 

export shipment, mark “USA” in conjunction with specification marking, 

or certificate identification; and package identification indicated in the 

U.S. Competent Authority Certificate

• Mark “DOT–SP” followed by the special permit number assigned for 

each package authorized by special permit

• Competent authority identification marking and revalidation for foreign 

made Type B(U), Type B(M), Type H(U), Type H(M), or fissile material 

package for which a Competent Authority Certificate is required

Special Considerations for Marking Requirements

• All markings are to be (a) on the outside of each package, (b) durable and legible, (c) in English, (d) printed on or affixed to the surface of a 

package or on a label, tag, or sign, (e) displayed on a background of sharply contrasting color, and (f) unobscured by labels or 

attachments.

• When an overpack is used, see §§ 173.25 and 173.448(g) for marking requirements.

[1] Some marking exceptions exist for excepted packages, as specified in §§ 173.421, 173.422, 173.424, 173.426 and 173.428. 

[2] If the identification number marking on a bulk package is not visible, the transport vehicle or freight container must be marked on each 

side and each end [see § 172.331].

[3] The radiation symbol shall be resistant to the effects of fire and water, plainly marked by embossing, stamping or other means resistant 

to the effects of fire and water and conform to the size requirements of Appendix B to Part 172.

[4] The arrows must be either black or red on white or other suitable contrasting background and commensurate with the size of the 

package; depicting a rectangular border around the arrows is optional.
O–8

6. Hazard Communications for Class 7 (Radioactive) Materials: 

Labeling of Packages (49 CFR 172.400-450)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information.

Requirements for Labels[1]

• Label each package, except for (a) excepted packages of radioactive material; and (b) Low Specific Activity (LSA) material and Surface 

Contaminated Objects (SCO), packaged or unpackaged, when transported under exclusive use controls domestically and when the 

material or object contains less than an A2 quantity.

• Labels are required to be (a) printed or affixed to a surface other than the bottom of the package, (b) placed near the proper shipping name 

marking, (c) printed or affixed to a background of contrasting color or have a dotted or solid line outer border, (d) clearly visible, (e) not 

obscured by markings or other attachments, (f) representative of the hazardous material content, and (g) in conformance with the label 

specifications of § 172.407.

• The appropriate radioactive label must be affixed to opposite sides or two ends (other than the bottom) of all non-bulk packages of 

radioactive material.

Category of Radioactive Labels [3] Other Radioactive Labels[2]

White-I Yellow-II Yellow-III Fissile Empty

Maximum Radiation Surface Level (RSL) Fissile labels required for 

each package containing 

fissile material, other than 

fissile-excepted material; 

and labels must be affixed 

adjacent to radioactive 

category labels.

Empty labels required 

for empty Class 7 

(radioactive) 

packages satisfying 

§ 173.428; and any 

previously-used labels 

must not be visible.

mSv/h RSL < 0.005 0.005 < RSL < 0.5 0.5 < RSL < 2[5]

mrem/h RSL < 0.5 0.5 < RSL < 50 50 < RSL < 200[5]

Transport Index (TI):[4]

TI = 0 0 < TI < 1 1 < TI < 10[5]

Contents on Labels

• Each radioactive category label must contain: (a) Except for LSA-I material, the names of the radionuclides in the package where, for 

mixtures of radionuclides, the names listed must be in accordance with the 95% rule specified in 

§ 173.433(g); and, for LSA-I material, the term “LSA-I”; (b) maximum activity in appropriate SI units (e.g., Bq, TBq), or appropriate 

customary units (e.g., Ci, mCi) in parentheses following SI units; and (c) for Yellow-II or Yellow-III labels the Transport Index (TI). 

Abbreviations and symbols may be used. Except for Pu-239 and Pu-241, the weight in g or kg of fissile radionuclides may be inserted 

instead of activity units; for Pu-239 and Pu-241, the weight in g of fissile radionuclides may be inserted in addition to the activity units [see 

§ 173.403 for fissile material definition].

• Each fissile label must contain the relevant Criticality Safety Index (CSI) [see § 172.403(e)]. 

[1] Additional labels may be required if the contents of a package contains material that also meets the definition of one or more other 

hazard class. See §§ 172.402 and 406(c) for details on additional labeling requirements. [see §§ 172.400a, 173.421 through 173.427

for details when labels are not required, and see § 172.407 for details on label durability, design, size, color, form identification, 

exceptions, and the trefoil symbol size].

[2] A “Cargo Aircraft Only” label is required for each package containing a hazardous material which is authorized for cargo aircraft only 

[see § 172.402(c)].

[3] The category of the label must be the higher of the two values specified for RSL and TI [see § 172.403(b)].

[4] The TI is determined from the radiation level 1 meter from the package surface [see TI definition in § 173.403]. If the measured TI is not 

greater than 0.05, the value may be considered to be zero. When an overpack is used, it must be labeled in accordance with 

§ 72.403(h).

[5] Packages with a TI > 10 or an RSL > 2 mSv/h (200 mrem/h) must be transported under exclusive use provisions [see § 173.441(b)]. 

Any package containing a Highway Route Controlled Quantity (HRCQ) must be labelled as RADIOACTIVE YELLOW-III.
O–9

7. Hazard Communications for Class 7 (Radioactive) Materials: Placarding (49 CFR 172, Subpart F)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

NOTE: IAEA, IATA/ICAO, and IMO may require additional hazard communication information.

Conditions when Display of Placards is Required [§§ 172.504, 172.507(a), 172.508, and 172.512]

• Each bulk package, freight container, unit load device[1], transport vehicle, or rail car containing any quantity of hazardous material 

must be placarded on each side and each end with the placards specified in § 172.504(e).

• Radioactive placards are required for: shipments that contain a package labeled as Radioactive Yellow-III; unpackaged LSA-I or 

SCO-I when transported under exclusive use provisions; shipments required by §§ 173.427, 173.441, and 173.457 to be operated 

under exclusive use; and closed vehicles marked “For Radioactive Materials Use Only” transported under § 173.443(d).

• The Radioactive placard is placed on a square background on any motor vehicle used to transport a package containing a Highway 

Route Controlled Quantity (HRCQ) Class 7 (radioactive) material[2].

Visibility and Display of Radioactive Placards [§ 172.516]

• Placards are required to:

• be clearly visible, on a motor vehicle and rail car, from the direction they face, except from the direction of another transport 

vehicle or rail car to which the motor vehicle or rail car is coupled[3]

• be securely attached or affixed thereto or placed in a holder thereon

• be located clear of appurtenances and devices such as ladders, pipes, doors, and tarpaulins

• be located, so far as practical, so dirt or water is not directed to it from the transport vehicle wheels

• be located at least 3 inches (76.0 mm) away from any marking (e.g. advertising) that could reduce its effectiveness

• have “RADIOACTIVE” printed on it displayed horizontally, reading from left to right

• be maintained by the carrier so format, legibility, color, and visibility of the placard will not be substantially reduced due to 

damage, deterioration, or obscurement by dirt or other matter

• be affixed to a background of contrasting color, or have a dotted or solid line outer border which contrasts with the background 

color.

Radioactive Placards

PLACARD (FOR OTHER THAN HRCQ) PLACARD FOR HRCQ

White triangular background color in the lower portion 

with yellow triangle in the upper portion; trefoil symbol, 

text, class number and inner and outer borders in black. 

[see § 172.556 and Appendix B of Part 172]

Square background must consist of a white square surrounded by 

one-inch black border. The placard inside the square is identical to 

that for other than HRCQ.

[see § 172.527]

General Specifications for Placards and Subsidiary Hazard Placarding

• Placards must conform to the specifications in § 172.519.

• A CORROSIVE placard is also required for each transport vehicle that contains 454 kg (1,001 pounds) or more gross weight of nonfissile, fissile-excepted, or fissile uranium hexafluoride [see § 172.505(b)].

• Placards are also required for subsidiary hazards of POISON INHALATION HAZARD, POISON GAS, or DANGEROUS WHEN WET 

[see § 172.505].

[1] See § 172.512 for exceptions and variations to the placarding requirements for freight containers and aircraft unit load devices. 

[2] See § 173.403 for the definition of Highway Route Controlled Quantity (HRCQ). A package containing an HRCQ must be labeled 

with RADIOACTIVE Yellow-III labels [see §§ 172.403(c) and 172.507(a)].

[3] Required placarding of the front of a motor vehicle may be on the front of a truck-tractor instead of or in addition to the placarding 

on the front of the cargo body to which a truck-tractor is attached § 172.516(b).
O–10

8. Requirements/Guidance for Registration, Emergency Response and Action for Class 7 (Radioactive) Materials: 

(49 CFR 107, Subpart G; 49 CFR 171.15; 49 CFR 172, Subparts F and G)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

Provisions for Persons Who Offer or Transport Class 7 (Radioactive) Materials (49 CFR 107, Subpart G)

• Any person, other than those excepted by § 107.606, who offers for transportation, or transports, in foreign, interstate or intrastate commerce any of the 

following Class 7 (radioactive) materials must satisfy registration and fee requirements of Part 107, Subpart G:

o a highway route-controlled quantity of radioactive material;

o a shipment in a bulk packaging with a capacity > 13,248 L (3,500 gallons) for liquids or gases, or > 13.24 cubic meters (468 cubic feet) for solids; or

o any quantity of radioactive material that requires placarding, under provisions of Part 172, Subpart F.

• Any person required to register must submit a complete and accurate registration statement on DOT Form F 5800.2 by June 30th for each registration 

year, or in time to have on file a current Certificate of Registration in accordance with § 107.620.

• Each registrant or designee must maintain for a period of 3 years from the date of issuance a copy of the registration statement and Certificate of 

Registration issued by PHMSA and must furnish its Certificate of Registration (or a copy thereof) and related records to an authorized representative or 

special agent of DOT upon request.

• Each motor carrier subject to registration requirements of this subpart must carry a copy of its current Certificate of Registration or another document 

bearing the registration number on board each truck and truck tractor, and the Certificate of Registration or document must be made available, upon 

request, to enforcement personnel.

• The amount of fees to be paid and procedures to be followed are found at §§ 107.612 and 107.616.

Provisions for Providing and Maintaining Emergency Response Information (49 CFR 172, Subpart G)

• When shipping papers for the transportation of radioactive materials are required [see Part 172, Subpart C], emergency response information shall

o be provided and maintained during transportation and at facilities where materials are loaded for transportation, stored incidental to transportation, or 

otherwise handled during any phase of transportation; 

o be provided by persons who offer for transportation, accept for transportation, transfer or otherwise handle hazardous materials during transportation;

o be immediately available for use at all times the hazardous material is present; and

o include and make available the emergency response telephone number [see § 172.604] to any person, representing a Federal, State or local 

government agency, who responds to an incident involving the material or is conducting an investigation which involves the material.

• Emergency response information is information that can be used in mitigating an incident involving radioactive materials. It must contain at least the 

information specified in §§ 172.602 and 172.604; and includes an emergency response telephone number that is monitored at all times the material is in 

transportation by (a) knowledgeable person, or (b) a person who has immediate access to a knowledgeable person, or (c) an organization capable of 

accepting responsibility for providing the necessary detailed information concerning the material.

• Each carrier who transports or accepts for transportation radioactive material for which a shipping paper is required shall instruct, according to the 

requirements of § 172.606, the operator of a conveyance to contact the carrier in the event of an incident involving the material.

Actions to be Taken in the Event of Spillage, Breakage, or Suspected Contamination by Radioactive Material

• If there is evidence of a leaking package or conveyance, access to the package or conveyance must be restricted, the area impacted and the extent of the 

contamination must be determined, and appropriate measures must be taken to minimize impact to persons and the environment [see § 173.443(e)].

• Except for a road vehicle used solely for transporting Class 7 (radioactive) material [see § 173.443(d)], each aircraft used routinely, and each motor vehicle 

used for transporting radioactive materials under exclusive use, must be (a) periodically checked for radioactive contamination, (b) taken out of service if 

contamination levels are above acceptable limits, and (c) remain out of service until the radiation dose rates at accessible surfaces are less than 

0.005 mSv/h (0.5 mrem/h) and non-fixed radioactive surface contamination levels are below the limits in §§ 173.443(a), Table 9; and 173.443(c) for 

exclusive use vehicle provisions [see Chart 3].

• Following any breakage, spillage, release or suspected radioactive contamination incident, any rail or air carrier shall notify, as soon as possible, the 

offeror (i.e. the consignor); special provisions apply for buildings, areas, and equipment that might become contaminated during rail transport. Alternative 

provisions may apply for motor vehicles transporting radioactive materials under exclusive use [see §§ 174.750(a), 175.705(e), and 177.843(b)].

Provisions for Immediate Notification for Reportable Incidents Involving Radioactive Materials (§§ 171.15 and 171.16)

• Each person in physical possession of radioactive material must provide notice in the event of a reportable incident (see § 171.15(b)) as soon as practical, 

but no later than 12 hours after the occurrence of the reportable incident, to the National Response Center (NRC) by telephone at 800–424–8802 (toll free)

or 202–267–2675 (toll call) or online at https://www.nrc.uscg.mil.

• Each notice must include the information specified in § 171.15(a)(1) – (a)(7).

• A detailed incident report must also submitted as required by § 171.16.

Guidance on Responding to Emergencies (Emergency Response Guidebook)

• The DOT issues guidance to aid first responders in quickly identifying the hazards of the dangerous goods involved in an accident or 

incident, and for protecting themselves and the general public during the initial response to the accident or incident. For each proper 

shipping name or UN ID Number, the user is led to a specific guide that provides insight into potential hazards and steps to be taken for 

public safety and emergency response.

• The current edition of the Emergency Response Guidebook is available at https://phmsa.dot.gov/hazmat/outreach-training/erg.
O–11

9. Requirements for Training and Safety and Security Plans for Class 7 (Radioactive) Materials:

(49 CFR 172, Subparts H and I, 49 CFR 173, and 10 CFR 37)

These are basic reference charts; refer to current U.S. DOT and NRC regulations for complete requirements.

Training (49 CFR 172, Subpart H)

• For any person who is employed by an employer or is self-employed, and who directly affects hazardous materials transportation 

safety, a systematic program shall be established to ensure that the person:

• has familiarity with the general provisions of Part 172, Subpart H;

• is able to recognize and identify radioactive materials;

• has knowledge of specific requirements of Part 172 that are applicable to functions performed by the employee;

• has knowledge of emergency response information, self-protection measures and accident prevention methods and procedures; 

and

• does not perform any function related to the requirements of Part 172 unless instructed in the requirements that apply to that 

function.

• The person shall be trained pursuant to the requirements of § 172.704(a) and (b), may be trained by the employer or by other public 

or private sources, and shall be tested by appropriate means. The training must include the following:

(a) general awareness training providing familiarity with applicable regulatory requirements;

(b) function-specific training applicable to functions the employee performs;

(c) safety training concerning emergency response information, measures to protect the employee from hazards, and methods and 

procedures for avoiding accidents;

(d) security awareness training providing awareness of security risks and methods designed to enhance transportation security; and

(e) in-depth security training if a security plan is required for the shipment(s) involved.

• Initial and recurrent training shall comply with the requirements of § 172.704(c).

• Records of training shall be created and retained in compliance with the requirements of § 172.704(d).

Security (49 CFR 172, Subpart I, 49 CFR 173, and 10 CFR 37)

• A security plan for hazardous materials that conforms to the requirements of Part 172, Subpart I must be developed and adhered to 

by each person who offers for transportation in commerce or transports in commerce in a motor vehicle, rail car, or freight container 

any of the following radioactive materials:

(a) IAEA Code of Conduct Category 1 and 2 materials (see §§ 172.800(b)(15) and 10 CFR 37);

(b) a highway route controlled quantity (HRCQ) of radioactive material as defined in § 173.403 [see § 172.800(b)(15)];

(c) known radionuclides in forms listed as radioactive material quantities of concern (RAM–QC) by the NRC [see §§ 172.800(b)(15) 

and 10 CFR 37]; or

(d) a quantity of uranium hexafluoride requiring placarding under § 172.505(b) [see § 172.800(b)(14)].

• The security plan must include an assessment of possible transportation security risks and appropriate measures to address the 

assessed risks.

• Specific measures put into place by the plan may vary commensurate with the level of threat at a particular time.

• At a minimum, a security plan must address personnel security, unauthorized access, and enroute security.

• The security plan must be

(a) in writing;

(b) retained for as long as it remains in effect;

(c) available as copies or portions thereof to the employees who are responsible for implementing it, consistent with personnel 

security clearance or background investigation restrictions and a demonstrated need to know;

(d) revised and updated as necessary to reflect changing circumstances; and

(e) maintained (all copies) as of the date of the most recent revision, when it is updated or revised.

• Security plans that conform to regulations, standards, protocols, or guidelines issued by other Federal agencies, international 

organizations, or industry organizations may be used to satisfy the requirements in Part 172, provided such security plans address 

the requirements specified in Part 172, Subpart I.

• Additional security planning requirements may apply for rail transport of a highway route controlled quantity of radioactive material 

[see §§ 172.820 and 173.403].

APPENDIX P

MODEL WASTE MANAGEMENT PROCEDURES

P–1

Model Waste Management Procedures

General Guidelines

• All radioactivity labels must be defaced or removed from containers and packages prior 

to disposal into ordinary “non-radioactive” waste streams. If waste is compacted, all 

labels that are visible in the compacted mass must be defaced or removed.

• Remind workers that non-radioactive waste such as leftover reagents, boxes, and 

packaging material should not be mixed with radioactive waste.

• Occasionally monitor all procedures to ensure that radioactive waste is not created 

unnecessarily. Review all new procedures to ensure that waste is handled in a manner 

consistent with established procedures.

• In all cases, consider the entire effect of various available disposal routes. Consider 

occupational and public exposure to radiation, other hazards associated with the 

material and routes of disposal (e.g., toxicity, carcinogenicity, pathogenicity,

flammability), and costs.

• The waste management program should include waste handling procedures for the 

users within their laboratories or assigned areas and for waste handlers who may collect 

waste from areas of use to bring to the storage area for eventual disposal.

• Housekeeping staff should be provided adequate training to avoid the possibility of 

unauthorized disposal or exposure of these individuals to radioactive materials or 

to radiation.

• A waste generator, collector, or processor who transports, or offers for transportation, 

low-level radioactive waste intended for ultimate disposal at a licensed low-level 

radioactive waste land disposal facility must prepare a Manifest in accordance with 

Title 10 of the Code of Federal Regulations (10 CFR) Part 20, Appendix G, 

“Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at 

Licensed Land Disposal Facilities and Manifests.”

Model Procedure for Disposal by Decay-in-Storage (DIS)

Applicants should ensure that adequate space and facilities are available for the storage of 

waste for DIS. Licensees can minimize the need for storage space if the waste is segregated 

according to physical half-life.

• Only short-lived waste (physical half-life of less than or equal to 120 days) may be 

disposed of by DIS.

• Short-lived waste should be segregated from long-lived waste.

• Waste should be stored in suitable well-marked containers, and the containers should 

provide adequate shielding.

• Liquid and solid wastes should be stored separately.
P–2

• When the container is full, it should be sealed. The sealed container should be identified 

with a label affixed or attached to it.

• The identification label should include the date when the container was sealed, the 

longest-lived radionuclide in the container, total activity, and the name of the individual 

who sealed the container. The container may be transferred to the DIS area. When 

large quantities are held for DIS, sufficient quantities may be present even after many 

half-lives and persons performing surveys should be aware of the potential for 

measurable radiation.

• The contents of the container should be allowed to decay for a period of time after which 

it is expected that the radiation levels would not be distinguishable from background. 

The period of time depends on both the half-life of the radionuclide(s) and the original 

amount present.

• Prior to disposal as ordinary trash, each container should be monitored with an 

appropriate radiation detection instrument, on the lowest setting, as follows:

— Check the radiation survey meter for proper operation.

— Survey the contents of each container in a low-background area.

— Remove any shielding from around the container.

— Monitor all surfaces of the container.

— Discard the contents as ordinary trash only if the surveys of the contents indicate 

no residual radioactivity (i.e., surface readings are indistinguishable from 

background).

— If the surveys indicate residual radioactivity, return the container to DIS area and 

contact the radiation safety officer for further instructions.

— If the surveys indicate no residual radioactivity, record the date when the 

container was sealed, the disposal date, type of waste (e.g., used or unused 

material, gloves, etc.), radiation survey instrument used, and the name of the 

individual performing surveys and disposing of the waste.

In accordance with 10 CFR 20.1904(b), all radiation labels must be defaced or removed from 

containers and packages prior to disposal as ordinary trash. Syringes and needles placed into 

sealed waste containers for decay do not need to have the labels removed, provided that the 

following is done: waste barrels are sealed prior to delivery to the waste disposal firm and 

delivered directly from the licensee’s facility; labels are removed from the waste barrels and 

containers; waste is incinerated, not placed in a landfill; and the waste disposal firm is cautioned 

not to open the container prior to incineration.

Model Procedure for Disposal of Liquids into Sanitary Sewerage

• Confirm that the sewer system is a public system, not a private sanitary sewer system, 

septic system, or leach field.
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• Confirm that the liquid waste being discharged is soluble (or is biological material that is 

readily dispersible) in water.

• Calculate the amount of each radionuclide that can be discharged by using the 

information from prior, similar discharges and the information in 10 CFR Part 20, 

Appendix B.

• Make sure that the amount of each radionuclide does not exceed the monthly and 

annual discharge limits specified in 10 CFR 20.2003(a)(4) and 10 CFR Part 20, 

Appendix B, Table 3.

• If more than one radionuclide is released, the sum of the ratios of the average monthly 

discharge of a radionuclide to the corresponding limit in 10 CFR Part 20, Appendix B, 

Table 3 must not exceed unity.

• Confirm that the total quantity of licensed material released into the sanitary sewerage 

system in a year does not exceed 185 gigabecquerel (GBq) [5 Curies (Ci)] of (tritium)

H-3, 37 GBq [1 Ci] of C-14, and 37 GBq [1 Ci] of all other radionuclides combined.

• Record the date, radionuclide(s), estimated activity of each radionuclide, location where

the material is discharged, and the name of the individual discharging the waste.

• Liquid waste should be discharged only via designated sinks, toilets, or other 

release points.

• Discharge liquid waste slowly to minimize splashing, with water running to be sure that 

the material moves out of the sink and into the sewer system.

• Survey the sink and surrounding work surfaces to confirm that no residual material or 

contamination remained in the sink or on work surfaces. 

• Decontaminate all areas or surfaces if found to be contaminated.

• Maintain records of releases of licensed material to the sanitary sewer system. These 

records should include, for each release, the date, radionuclide(s), estimated activity of 

each radionuclide, location where the material is discharged, and the name of the 

individual discharging the waste. For the licensed facility as a whole, records should be 

maintained of the quantity and concentration of radionuclides that are released into the 

sewer system that demonstrate compliance with the regulatory limits for total quantity 

released and concentrations released by the licensed facility.

Model Procedure for Incineration

These guidelines apply to non-commercial waste disposal (i.e., incineration of a licensee’s own 

waste). Specific U.S. Nuclear Regulatory Commission (NRC) approval to incinerate certain 

categories of radioactive waste is not needed. For example, 10 CFR 20.2005 provides that 

tritium and carbon-14 in low-level concentrations in liquid scintillation media and animal tissue 

may be disposed of without regard to radioactivity. If a review of the radioactive waste program 

identifies waste that requires specific NRC approval for incineration, please provide the 

following information:
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• Describe the training and experience of the person who will be responsible for the 

on-site and day-to-day supervision of incinerator operations.

• Describe the waste that is proposed to be incinerated, to include: the chemical and 

physical form of the waste containing licensed material and a description of how the 

waste is segregated, packaged, and labeled for transfer from the generation site to the 

incinerator; the name of the radionuclide; concentration of radioactivity averaged over 

the weight of the material to be incinerated (microcuries per gram of waste medium) for 

each isotope to be incinerated; and the total radioactivity of each isotope per burn and 

the total number of burns per year. Describe procedures for ensuring that these 

frequencies and activities will not be exceeded.

• Describe the procedures for packaging, handling, securing, and monitoring of waste to

prevent contamination or unnecessary exposure to personnel or property during the 

waste life cycle.

• Describe the method for measuring or estimating the concentration of radioactive 

material remaining in the ash residue. Describe the procedures for collection, handling, 

and disposal of the ash residue.

• Describe the recordkeeping procedures for the waste incineration program. Records 

must be adequate to document all receipts, incinerations, environmental releases of 

effluents, and any disposals of ash generated in the incineration process. These records 

must be maintained in the same units as applicable regulations.

• Describe the characteristics of the incinerator and site location, including height of the 

stack, rated air flow (cubic feet per hour or similar units), proximity of the stack or other 

discharge to occupied areas (e.g., residences, schools, hospitals), and distance to the 

nearest air-intake ducts of adjacent buildings. Describe any scrubbers, filters, or air 

cleaning equipment that is present.

• State how the concentration of radionuclides released, both as airborne effluent and as 

any liquid effluent from scrubbers, condensers, or associated systems, will be measured 

or otherwise determined. Describe any stack monitoring that is planned.

• Provide a copy of the written safety analysis that demonstrates the applicant or licensee 

will be able to incinerate the types and quantities of radioactivity specified in the 

application without exceeding the environmental release limits specified in 

10 CFR Part 20.

• Provide a written commitment that the applicant or licensee has coordinated with 

appropriate State and local authorities and that such permits and other authorizations, 

as may be necessary, have been obtained.

• Provide a copy of the radiation safety procedures for monitoring personnel involved in 

incineration operations and for monitoring all effluent generated by the incineration 

process. The procedures must ensure that regulatory limits for environmental releases 

of radioactivity will not be exceeded. The applicant should describe the disposal method 

for any ash generated that exceeds regulatory limits.
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Model Procedure for Compaction

The following information should be provided by licensees that propose to compact waste.

• Describe the compactor to demonstrate that it is adequately designed and manufactured 

to safely compact the type and quantity of waste generated during licensed operations.

Provide manufacturer’s specifications, annotated sketches or photographs, and other 

information about the compactor’s design.

• Describe the type, quantities, and concentrations of waste to be compacted.

• Provide an analysis of the potential for airborne release of radioactive material during 

compaction activities.

• Provide the location of any compactors within the waste processing area(s), as well as a 

description of the ventilation and filtration systems used in conjunction with the 

compactors. Include a description of the procedures for monitoring filter blockage 

and exchange.

• Discuss the methods used to monitor worker breathing zones and exhaust systems.

• Discuss the types and frequencies of surveys that will be performed for contamination 

control in the compactor area.

• Discuss the instruction provided to compactor operators, including instructions for 

protective clothing, checks for proper functioning of equipment, method of handling 

uncompacted waste, and examining containers for defects.

APPENDIX Q

SAFETY CULTURE POLICY STATEMENT 

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Safety Culture

The Safety Culture Policy Statement was published in the Federal Register (76 FR 34773) on 

June 14, 2011, and can be found at https://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/

2011-14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission’s (NRC) 

Agencywide Documents Access and Management System, Accession No. ML11146A047. 

Safety Culture Policy Statement

The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

individuals and organizations establish and maintain a positive safety culture, commensurate 

with the safety and security significance of their activities and the nature and complexity of their 

organizations and functions. This includes all licensees, certificate holders, permit holders,

authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

safety-related components, and applicants for a license, certificate, permit, authorization, or 

quality assurance program approval, subject to NRC authority. The Commission encourages 

the Agreement States, Agreement State licensees and other organizations interested in nuclear 

safety to support the development and maintenance of a positive safety culture, as articulated in 

this Statement of Policy.

Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

commitment by leaders and individuals to emphasize safety over competing goals to ensure 

protection of people and the environment. Individuals and organizations performing regulated 

activities bear the primary responsibility for safety and security. The performance of individuals 

and organizations can be monitored and trended and, therefore, may be used to determine 

compliance with requirements and commitments and may serve as an indicator of possible 

problem areas in an organization’s safety culture. The NRC will not monitor or trend values. 

These will be the organization’s responsibility as part of its safety culture program.

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

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

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

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

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

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

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

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

with NRC-regulated activities.

Experience has shown that certain personal and organizational traits are present in a positive 

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

emphasizes safety, particularly in goal conflict situations (e.g., production, schedule, and the 

cost of the effort versus safety). It should be noted that although the term ‘‘security’’ is not

expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

regulatory mission. Consequently, consideration of both safety and security issues, 

commensurate with their significance, is an underlying principle of this Statement of Policy.
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The following are traits of a positive safety culture:

(1) Leadership Safety Values and Actions—Leaders demonstrate a commitment to safety in 

their decisions and behaviors,

(2) Problem Identification and Resolution—Issues potentially impacting safety are promptly 

identified, fully evaluated, and promptly addressed and corrected commensurate with 

their significance,

(3) Personal Accountability—All individuals take personal responsibility for safety,

(4) Work Processes—The process of planning and controlling work activities is implemented 

so that safety is maintained,

(5) Continuous Learning—Opportunities to learn about ways to ensure safety are sought out 

and implemented,

(6) Environment for Raising Concerns—A safety conscious work environment is maintained 

where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

harassment, or discrimination,

(7) Effective Safety Communication—Communications maintain a focus on safety,

(8) Respectful Work Environment—Trust and respect permeate the organization, and

(9) Questioning Attitude—Individuals avoid complacency and continuously challenge 

existing conditions and activities in order to identify discrepancies that might result in 

error or inappropriate action.

There may be traits not included in this statement of policy that are also important in a positive 

safety culture. It should be noted that these traits were not developed to be used for 

inspection purposes.

It is the Commission’s expectation that all individuals and organizations, performing or 

overseeing regulated activities involving nuclear materials, should take the necessary steps to 

promote a positive safety culture by fostering these traits as they apply to their organizational 

environments. The Commission recognizes the diversity of these organizations and 

acknowledges that some organizations have already spent significant time and resources in the 

development of a positive safety culture. The Commission will take this into consideration as 

the regulated community addresses the statement of policy.
APPENDIX R

MEDICAL DISTRIBUTION

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Medical Distribution

1. INTRODUCTION

1.1 Purpose of Appendix

The purpose of this appendix is to provide assistance in preparing applications for new licenses, 

license amendments, and renewals of medical distribution licenses under Title 10 of the Code of 

Federal Regulations (10 CFR) Part 32, “Specific domestic licenses to manufacture or transfer 

certain items containing byproduct material.” These are licenses that authorize the distribution 

of radioactive drugs and sealed sources containing byproduct material to the U.S. Nuclear 

Regulatory Commission’s (NRC’s) and Agreement States’ medical use licensees. Nuclear 

pharmacy applicants should refer to NUREG–1556, Vol. 13 in the preparation of an application 

for transfer for distribution of radioactive drugs for medical use instead of guidance in this 

appendix. Medical distribution by applicants registered or licensed with the U.S. Food and Drug 

Administration (FDA) or State Agency as a drug or sealed source manufacturer is provided for 

in 10 CFR 32.72 and 32.74 or equivalent provisions of an Agreement State. The medical 

distribution license normally only authorizes distribution; it does not authorize the possession of 

byproduct material. 

NUREG–1556, Vol. 13, “Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Commercial Radiopharmacy Licenses,” contains much of the information 

needed in preparing applications for medical distribution licenses. To avoid duplication, many 

sections in this appendix will refer to NUREG–1556, Vol. 13. 

Several words and phrases used in this guide should be explained. The phrase “byproduct 

material” is defined in 10 CFR 30.4. The term “distribution” has the same meaning as in 

10 CFR Part 32 (i.e., the routine transfer of licensed materials to others). For organizations 

licensed in accordance with 10 CFR 32.72 and 32.74, these transfers of licensed material are to 

specific licensees, in accordance with the requirements of 10 CFR 30.41. These organizations’ 

principal customers are medical use licensees. The phrase “medical use licensee” means a 

physician, podiatrist, dentist, or medical institution licensed under 10 CFR Part 35 for “medical 

use,” as defined in 10 CFR 35.2.

1.2 Filing an Application for Broad Scope Licenses to Manufacture and Distribute 

Radio Labeled Drugs to Medical Use Licensees for Research

Broad scope research and development licensees that wish to manufacture and distribute drugs 

containing byproduct material to medical use licensees for research purposes may request an 

exemption from 10 CFR 32.72(a)(2). The NRC may grant an exemption under 

10 CFR 30.11(a), if the applicant or licensee specifically requests an exemption from 

10 CFR 32.72(a)(2) and provides the following supporting information with regard to the 

requirements of 10 CFR 32.72(a)(2):

• 32.72(a)(2)(i)—The applicant or licensee must confirm that only radioactive drugs for 

which the FDA has accepted an Investigational New Drug (IND) application containing

microcurie quantities of hydrogen-3 or carbon-14 will be prepared and distributed. 

(The FDA, in 21 CFR 207.13(e), exempts classes of persons who manufacture or 

process drugs not for sale, but solely for use in research, teaching, and chemical 

analysis, from registering with the FDA as a drug manufacturer.)
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• 32.72(a)(2)(ii)—The applicant or licensee must confirm that it is not registered with the 

State as a drug manufacturer.

• 32.72(a)(2)(iii)—The applicant or licensee must confirm that it is not licensed as a 

pharmacy. The risk imposed by the radioactive drugs containing only microcurie 

quantities of hydrogen-3 or carbon-14 does not warrant imposing the additional burden 

of hiring an Authorized Nuclear Pharmacist for the license.

• 32.72(a)(2)(iv)—The applicant or licensee must confirm that it is not operating as a 

nuclear pharmacy within a Federal institution.

• 32.72(a)(2)(v)—The applicant or licensee must confirm that it is not operating as a 

Positron Emission Tomography drug production facility registered with a State Agency.

• The applicant or licensee must agree to meet all other applicable sections of 

10 CFR 32.72. If the exemption is granted, the following authorized use will be 

added to the license for hydrogen-3 and carbon-14:

— preparation and distribution of radioactive drugs to authorized recipients in 

accordance with 10 CFR 32.72

In addition, the following license condition will be added to the license:

— Notwithstanding 10 CFR 32.72(a)(2), the licensee is authorized to prepare 

radioactive drugs, in accordance with an accepted FDA IND application protocol,

and to distribute them to medical use licensees in accordance with 

10 CFR 32.72.

Since this exemption applies to broad scope research and development licensees, the broad 

scope licensee will not be required to obtain an exemption from 10 CFR 33.17(a)(4), which 

restricts broad scope licensees from adding byproduct material to drugs designed for human 

use when applying for 10 CFR 32.72 authorization. The addition of authorization to 

manufacture, prepare, or transfer radioactive drugs containing byproduct material for medical 

use (10 CFR 32.72) to a license authorizes Part 32 activities in addition to Part 33 (broad scope) 

activities. Preparation of radioactive drugs is done under the Part 32 authorization and not the 

Part 33 authorization.

2. CONTENTS OF AN APPLICATION

The following paragraphs are numbered as on NRC Form 313, “Application for Material 

License,” Appendix A of this NUREG.

Item 1: License Action Type

See Section 8.1.

Item 2: Applicant’s Name and Mailing Address

See Section 8.2.
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Item 3: Locations of Use

See Section 8.3.

Item 4: Person to Be Contacted About the Application

See Section 8.3.

Items 5 and 6: Radioactive Materials and Uses

Apply for a license as stated in 10 CFR 30.32. Identify the materials the applicant wishes to be 

authorized to distribute to NRC and Agreement States medical use licensees. The regulatory 

requirements and the information that applicants must submit are different for radioactive drugs

and for sealed sources.

For radioactive drugs, specify the radionuclide and chemical form (for generators, specify the 

parent and daughter radionuclides and the name and model number, if appropriate, of the 

generator). For sealed sources, specify the radionuclide, manufacturer’s name and model 

number of each source, the maximum activity in each source, and the anticipated use of the 

sources. NRC needs to know the anticipated use of the source to perform its safety evaluation. 

If the sealed sources are usually used in a device (e.g., bone mineral analyzer), specify the 

manufacturer’s name and the model number of the device.

The following examples show appropriate responses to Items 5 and 6.

• Radioactive Drugs

— Chromium-51 as Sodium Chromate

— Molybdenum-99 as Molybdenum-99/Technetium-99m Generator (Model MTG-1)

— Maximum activity per radionuclide

• Sealed Sources

— Cesium-137, XYZ Corp., Model 1234

— Maximum activity per source: 100 mCi

— To be used by medical use licensees as dose calibrator reference sources as 

authorized in 10 CFR 35.65. Strontium-90, ABC Corp., Model 567

— Maximum activity per source: 150 millicuries

— To be used as a strontium-90 beta eye applicator for treatment of superficial 

eye conditions

— Iodine-125, FGH Corp., Model 890

— Maximum activity per source: 300 millicuries

— To be used in an FGH Corp. Model BMA-1 device for bone mineral analysis
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Item 7: Individuals Responsible for Radiation Safety Program and Their Training 

and Experience

Enter “Not Applicable.”

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

Enter “Not Applicable.”

Item 9: Facilities and Equipment

Enter “Not Applicable.”

Item 10: Radiation Safety Program

According to 10 CFR 32.72 and 32.74, certain radiation safety information must be submitted 

regarding licensed material to be distributed to medical use licensees. The information to be 

submitted for each type of licensed material to be distributed to medical use licensees is 

identified in the following sections and in NUREG–1556, Vol. 13, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses.”

Item 10.1: Radioactive Drugs

If the applicant wishes to distribute radioactive drugs to medical use licensees, pursuant to 

10 CFR 35.100, 35.200, 35.300 or, 35.1000, they need to provide the information identified 

below and, where applicable, in NUREG–1556, Vol. 13, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses,”

for nuclear pharmacy license applicants.

Item 10.1.1: Radioactive Drugs—Commercial Distribution

Under 10 CFR 32.72(a)(2)(i) and 10 CFR 32.72(a)(2)(ii), the applicant must provide evidence 

that they are registered or licensed with either the FDA or a State Agency as a drug 

manufacturer. See NUREG–1556, Vol. 13, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Commercial Radiopharmacy Licenses,” for nuclear pharmacy 

license applicants.

Item 10.1.2: Radioactive Drugs—Instrumentation

Under 10 CFR 32.72(c), the applicant must possess and use instrumentation to measure the 

radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for 

commercial distribution. Measurements may be made by direct measurement or a combination 

of direct measurement and calculation (calculation only may be used for alpha and beta 

radiation). See NUREG–1556, Vol. 13, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Commercial Radiopharmacy Licenses,” for nuclear pharmacy 

license applicants.

Item 10.1.3: Radioactive Drugs—Packaging and Shielding Licensing Criteria

See NUREG–1556, Vol. 13, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Commercial Radiopharmacy Licenses.”
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Item 10.1.4: Radioactive Drugs—Licensing Criteria for Labeling

See NUREG–1556, Vol. 13, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About Commercial Radiopharmacy Licenses.”

Item 10.1.5: Generators—Return Program

Some licensees offer a generator return program. Under this program, customers may return 

used or spent generators to the licensee. The applicant should develop and provide written 

procedures for customers that address the return of generators.

Item 10.1.5.1: Licensing Criteria

If the applicant wishes to offer a generator return program, it may be helpful to supply 

instructions (including instructions on labeling and shipping documents) to their customers. The 

shipper must comply with 10 CFR 71.5 and with U.S. Department of Transportation (DOT)

regulations. As a minimum, these instructions should

• Establish the user’s responsibility and liability as the shipper.

• Provide step-by-step instructions for completing each item on each form and label that is 

involved in the shipping process.

• Discuss all the customer’s responsibilities as a shipper under 49 CFR Parts 170 to 189.

Response from Applicant: 

Provide a response as indicated at the end of each relevant item of NUREG–1556, Vol. 13, 

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

Commercial Radiopharmacy Licenses.”

Item 10.2: Sealed Sources

If the applicant intends to distribute sealed sources to medical use licensees, provide the 

information identified in NUREG–1556, Vol. 13, “Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses.”

Item 10.2.1: Sealed Sources in Devices—Licensing Criteria for Evaluation of Design 

and Construction

If the applicant is a manufacturer or initial distributor of sealed sources (or devices containing 

sealed sources), they may need to submit a separate application for authorization to distribute 

the sealed sources or devices. This separate application will facilitate NRC’s review and 

evaluation of the radiation safety information for the sealed source or device and its certificate of 

registration. To submit a source or device design for a safety evaluation and registration use

NUREG–1556, Vol. 3, “Consolidated Guidance About Materials Licenses: Applications for 

Sealed Source and Device Evaluation and Registration.” This safety evaluation is required by 

10 CFR 32.74 prior to the source or device being approved for distribution and medical use.
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Item 10.2.2: Sealed Sources—Labeling

Item 10.2.2.1: Licensing Criteria

The applicant’s product labeling must fulfill the requirements of 10 CFR 20.1901, 20.1904, 

20.1905, and of 10 CFR 32.74(a)(2)(viii) and 32.74(a)(3).

A label, leaflet, or brochure accompanying the sealed source or device must contain appropriate 

instructions, from a radiation safety standpoint, for handling and storing the source or device. 

For example, the instructions may specify the use of extremity monitors, the use of tongs or 

other devices (rather than bare hands) to pick up sources, storage within auxiliary shielding, 

and any special procedures needed in the handling and sterilizing of “fragile” sources 

(e.g., iodine-125 seeds).

A label, leaflet, or brochure must also contain the licensing statement required by 

10 CFR 32.74(a)(3). For sources, the statement should read, “The (name of source or device) 

is licensed by the NRC for distribution to persons licensed pursuant to use byproduct material 

identified in 10 CFR 35.65, 35.400, 35.500, and 35.600 as appropriate, and to persons who hold 

an equivalent license issued by an Agreement State.”

For each type of sealed source or device the applicant intends to distribute, they should:

• Submit copies or facsimiles of the labels that will accompany the product and specify 

where each label will be placed (e.g., on the device, on the source shield).

• Submit copies of all leaflets and brochures that will accompany the product. For each

type of source or device to be distributed, the applicant should provide a copy of 

correspondence to and from the FDA that clearly shows that the FDA finds the source or 

device to be safe and effective or “substantially equivalent” to sources or devices offered 

for sale in the U.S. before May 1976. (Note: An NRC registration will not be issued 

unless the applicant has submitted to NRC a substantially equivalent letter pursuant to

Section 510(K) of the Food, Drug, and Cosmetic Act, as amended, or a similar indication 

of premarketing approval by the FDA.).

Devices and sources used in conjunction with medical applications involving computers and 

patient planning systems are within FDA jurisdiction and must also have a substantially 

equivalent letter, pursuant to Section 510(k) of the Food, Drug, and Cosmetic Act, as amended, 

or a similar indication of premarketing approval by FDA.

Item 10.2.2.2: FDA and NRC Coordination

FDA and NRC signed a Memorandum of Understanding [Agencywide Document Access and 

Management System (ADAMS) Accession No. ML023520399] to coordinate existing FDA and 

NRC regulatory programs for medical devices, drugs, and biological products that make use of 

byproduct, source, or special nuclear materials. The principal statute under which the FDA 

regulates devices is the Food, Drug, and Cosmetic Act, as amended by the Safe Medical 

Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Medical Devices 

Act of 1992.

Under the Memorandum of Understanding, the Agencies agree to promptly inform each other 

whenever they receive a report or otherwise become aware of potential public health problems 
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involving products of mutual regulatory concern. Further, the Agencies will share information to 

the extent practicable. For NRC’s Office of Nuclear Materials Safety and Safeguards (NMSS), 

this includes information on the design, manufacture, testing, quality assurance, and control, 

etc., used by FDA and NRC for its product approval.

Item 10.2.3: Sealed Sources—Return Program and Device Service

Item 10.2.3.1: Returns

Some licensees offer a source return program or a device service or both. In this program, 

customers may return unused sources for credit or may return used sources or devices for 

disposal, service, or replacement. Similar programs have been offered by manufacturers of 

other products. As indicated in Item 10.1.5.1 licensees may want to provide assistance to 

customers to remind customers of their responsibilities as shippers.

Item 10.2.3.2: Licensing Criteria

See Item 10.1.5.1 for information to be included in instructions that may be provided to 

the customers.

Item 10.2.4: Calibration or Reference Sources For Medical Use—Compatibility with 

10 CFR 35.65 Licensing Criteria

The applicant must request authorization to distribute calibration or reference sources that are 

described in 10 CFR 35.65. These calibration or reference sources must not exceed the 

activity limits of 10 CFR 35.65, and according to 10 CFR 32.74, the applicant must confirm this 

in their license application.

If a source to be distributed contains byproduct material exceeding the activity limits of

10 CFR 35.65, source material, or special nuclear materials, it may not be distributed to medical 

licensees under the provisions of 10 CFR 35.65. In such cases, medical use licensees may 

purchase such sources only if their licenses specifically authorize possession and use of them. 

In these cases, the applicant or licensee may not use a license issued under 10 CFR 32.74 to 

distribute the sources; rather, they need a license issued pursuant to 10 CFR Part 30, 40, or 70, 

as appropriate, that authorizes them to distribute such sources to their proposed customers.

Response from Applicant: 

Provide a response as indicated at the end of each relevant item of NUREG–1556, Vol. 13, 

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

Commercial Radiopharmacy Licenses.”

Item 11: Waste Management

Enter “Not Applicable.”

Item 12: License Fees

See Section 8.12.
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Item 13: Certification

See Section 8.13.

Termination of Activities

See Section 11 of this report.

The distribution license does not authorize the possession and use of byproduct material; 

therefore, termination of the licensee’s distribution license only requires a letter notifying NRC of 

the termination. If the licensee is also terminating their possession license, 10 CFR 30.36(b) 

requires that a licensee notify NRC promptly and request termination of the license. This 

notification normally requires (i) a completed form NRC-314, “Certificate of Disposition of 

Materials,” certifying that all sources have been disposed of properly and (ii) the results of a final 

radiation survey of the premises where the licensed activities were carried out.
APPENDIX S

CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)

S–1

Checklist for Requests to Withhold Proprietary 

Information From Public 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. 12

Revision 1, Final

Consolidated Guidance About Materials Licenses: Program-Specific Guidance 

About Possession Licenses for Manufacturing and Distribution