Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

Service Provider Licenses

Final Report 

Office of Nuclear Materials Safety and Safeguards

NUREG-1556

Volume 18, Rev. 1

Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

Service Provider Licenses

Final Report 

Manuscript Completed: August 2017 

Date Published: August 2017 

Prepared by

L. Dimmick

J. Dalzell-Bishop

K. Modes

J. Walden

R. J. Torres

Office of Nuclear Materials Safety and Safeguards

 

NUREG-1556

Volume 18, Rev. 1

iii

ABSTRACT

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

assist applicants and licensees in preparing applications for materials licenses for service 

providers. 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 3150-0044, 3150-0014, 

3150-0035, 3150-0017, 3150-00016, 3150-0001, 3150-0010, 3150-0214, 3150-0130, 

3150-0009, 3150-0008, and 3150-0120.

Public Protection Notification

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

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

currently valid OMB control number.

v

FOREWORD

The U.S. Nuclear Regulatory Commission’s (NRC’s) 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
vi

The current document, NUREG–1556, Volume 18, Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Service Provider Licenses,” 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 18, issued November 2000 to 

incorporate certain security requirements and other regulatory and policy changes that have 

been implemented since the last revision was published.

This report takes a risk-informed, performance-based approach to licensing service providers. 

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 service providers. NUREG–1556, Volume 18, 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 they include a basis for the NRC staff to 

make the determinations needed to issue or renew a license.

The comments received during the public comment period for NUREG–1556, Volume 18, 

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

Agencywide Documents and Management System (ADAMS) under ML16036A128. Access to 

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

The comments NRC received included general corrections and comments on security of 

nuclear materials.

________________________________________

Daniel S. Collins, Director

Division of Materials Safety, State, Tribal, and Rulemaking 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

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

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

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

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

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

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

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

Sealed Sources...........................................................................................8-5

Unsealed Radioactive Material....................................................................8-7

Recordkeeping for Decommissioning..........................................................8-9

Financial Assurance..................................................................................8-10

Emergency Plan........................................................................................8-11

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

Authorized Users and Radiation Workers..................................................8-15
viii

Operating and Emergency Procedures .....................................................8-22

Material Receipt and Accountability...........................................................8-29

Radiation Monitoring Instruments..............................................................8-37

Surveys.....................................................................................................8-39

Types of Surveys..........................................................................8-40

Contamination Survey Frequency.................................................8-41

Contamination in Unrestricted Areas ............................................8-42

Survey Record Requirements.......................................................8-43

Air Monitoring in the Workplace....................................................8-43

Airborne Effluent Release Monitoring ...........................................8-43

Liquid Effluent Release Monitoring ...............................................8-44

Leak Tests ................................................................................................8-45

Occupational Dose....................................................................................8-47

Public Dose...............................................................................................8-51

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

Maintenance .............................................................................................8-56

Audit and Review of Program....................................................................8-59

Security Program for Category 1 and Category 2 Materials.......................8-61

9 LICENSE AMENDMENTS AND RENEWALS ..................................................................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 NRC FORM 313................... B–1

APPENDIX C TYPICAL DUTIES AND RESPONSIBILITIES OF THE RADIATION

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

APPENDIX D CRITERIA FOR ACCEPTABLE TRAINING AND EXPERIENCE FOR 

AUTHORIZED USERS ................................................................................ D–1

APPENDIX E MATERIAL ORDERING AND PACKAGE RECEIPT AND OPENING......... E–1

APPENDIX F RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND

MODEL RADIATION SURVEY INSTRUMENT AND AIR SAMPLER 

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

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

APPENDIX H GUIDANCE FOR DEMONSTRATING THAT UNMONITORED

INDIVIDUALS ARE NOT LIKELY TO EXCEED 10 PERCENT OF

THE ALLOWABLE LIMITS ........................................................................ H–1

APPENDIX I GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL MEMBERS

OF THE PUBLIC WILL NOT RECEIVE DOSES EXCEEDING

THE ALLOWABLE LIMITS ...........................................................................I–1

APPENDIX J U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS...................J–1
ix

APPENDIX K INFORMATION NEEDED TO SUPPORT APPLICANT’S REQUEST

TO PERFORM NONROUTINE MAINTENANCE CHECKLIST.................... K–1

APPENDIX L SUGGESTED SERVICE PROVIDER AUDIT CHECKLIST ..........................L–1

APPENDIX M MODEL WASTE DISPOSAL PROGRAM....................................................M–1

APPENDIX N SAFETY CULTURE STATEMENT OF POLICY.......................................... N–1

APPENDIX O CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

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

xi

FIGURES

Figure Page

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

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

8-2 Examples of Sealed Sources or Devices Possessed, Used, or Serviced......................8-6

8-3 Material Receipt and Accountability............................................................................8-32

8-4 Examples of Portable Instruments..............................................................................8-37

8-5 Types of Surveys........................................................................................................8-40

8-6 Personnel Surveys .....................................................................................................8-41

8-7 Annual Dose Limits for Adult Radiation Workers ........................................................8-49

8-8 Calculating Public Dose..............................................................................................8-53

I–1 Bird’s-Eye View of Office with Stored Calibration Source.............................................. I-5

I–2 Down-Hole Storage Array in Waste Broker Facility....................................................... I-7

TABLES

Table Page

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

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

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

8-2 Regulatory Required Notifications .............................................................................8-25

8-3 Package Monitoring Requirements (10 CFR 20.1906)................................................8-31

8-4 Record Maintenance ..................................................................................................8-34

8-5 Suggested Contamination Survey Frequency.............................................................8-41

B–1 Items 5 & 6: Unsealed Radioactive Materials To Be Possessed and 

Proposed Uses........................................................................................................... B–2

B–2 Items 5 & 6: Sealed Radioactive Materials To Be Possessed and 

Proposed Uses........................................................................................................... B–2

B–3 Items 5 & 6: Source and Special Nuclear Materials To Be Possessed 

and Proposed Uses.................................................................................................... B–2

B–4 Items 5.3 through 11: Training and Experience, Facilities and Equipment, 

Radiation Safety Program, and Waste Disposal ......................................................... B–5

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

H–1 Dosimetry Evaluation..................................................................................................H–2

I–1 Doses to Members of the Public...................................................................................I–1

I–2 Standard Occupancy Factors .......................................................................................I–4

I–3 Information Known about Dose at the Shield of the Cs-137 Source..............................I–7
xii

I–4 Calculation Method, Part 1: Hourly and Annual Doses Received From a 

Source Stored Above Ground.......................................................................................I–8

I–5 Calculation Method, Part 2: Annual Dose Received From a Source Stored 

Above Ground ..............................................................................................................I–9
xiii

ACKNOWLEDGMENTS

The working group would like to thank the staff in the regional offices of the NRC and all of the 

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

this report.

The working group also thanks John O’Donnell, Monica Ford, Tara Weidner, Tomas Herrera,

and Duane White for developing the formatting and language used in many parts of the report. 

The Participants for this Revision

Dalzell-Bishop, Jennifer

Dimmick, Lisa

Gilman, Joseph

Lenehan, Daniel

Modes, Kathy

Torres, Roberto J.

Walden, Judee

xv

ABBREVIATIONS

ADAMS Agencywide Document and Access 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

CEDE committed effective dose equivalent

CFR Code of Federal Regulations

Ci curie

cpm counts per minute

DFP decommissioning funding plan

DIS decay-in-storage

DOT U.S. Department of Transportation

dpm disintegrations per minute

EA environmental assessment

FA financial assurance

FR Federal Register

GBq gigabecquerel

Gy gray

HDR high dose rate

HEPA high efficiency particulate air

IN Information Notice

ISO International Organization for Standardization

LLEA local law enforcement agency

LLW low-level radioactive waste

MARSAME Multi-Agency Radiation Survey and Assessment of Materials and

 Equipment Manual

MARSSIM Multi-Agency Radiation Survey and Site Investigation Manual

MBq megabecquerel

mCi millicuries

MDA minimum detectable activity

MDC minimum detectable concentration

mrem millirem

mSv millisievert
xvi

NaI sodium iodide

NCRP National Council on Radiation Protection and Measurements

NMSS Office of Nuclear Material Safety and Safeguards

NRC U.S. Nuclear Regulatory Commission

NSTS National Source Tracking System

NSTTR National Source Tracking Transaction Reports

NVLAP National Voluntary Laboratory Accreditation Program

OEM Original Equipment Manufacturer

OMB Office of Management and Budget

PIC Pocket Ionization Chamber

PII Personally Identifiable Information

Q quality factor

QA quality assurance

RG regulatory guide

RIS regulatory issue summary

RQ reportable quantities

RSO radiation safety officer

RSRM Risk Significant Radioactive Material

SA State Agreement

SNM special nuclear material

SSD sealed source and device

std standard

Sv sievert

TEDE total effective dose equivalent

TLD thermoluminescent dosimeter

U.S.C. United States Code
1-1

1 PURPOSE OF REPORT

This report provides guidance to an applicant in preparing a service provider license 

application based on the risk significance of the proposed activity, as well as providing the 

U.S. Nuclear Regulatory Commission (NRC) staff with the appropriate criteria for evaluating 

such applications.

Service providers offer a variety of commercial services to both specific and general licensees, 

ranging from low- to high-risk activities, and in some instances, recover both licensed and 

unlicensed material from the public domain. Customers who possess such radioactive material 

may require commercial services to manage materials at concentrations and activities they are 

not authorized to handle. In these unique situations, a service provider licensee is authorized to 

possess these radioactive materials under its license incident to performing specific services 

required by its customers. Optionally, customers may elect to transfer licensed material, such 

as radioactive waste and contaminated materials, to service providers (e.g., radioactive 

waste brokers, decontamination and decommissioning service providers, or nuclear 

laundry operators).

Service providers who, in the course of doing business, receive physical samples and possess 

equipment containing licensed materials related to the performance of commercial service 

activities—such as leak test and environmental sample analyses and survey instrument and 

dosimetry calibration services—are also included in this category.

Service providers addressed in this NUREG are limited to licensed entities providing the 

following types of commercial services based on low- or high-risk activities. These commercial 

services were subjectively categorized in this NUREG as low- or high-risk activities solely for the 

purpose of licensing guidance for service provider applicants and licensees in order to clarify for 

the applicant the type of information that needs to be submitted to support the request for the 

commercial service(s) being licensed. 

LOW RISK—Possession or use incidental to performing the following commercial services:

• analysis of leak-test samples (no collection of leak-test samples)

• analysis of environmental samples (no collection of environmental samples)

• training/instruction to individuals on radiation safety-related topics

• packaging for shipment of radioactive materials in less than U.S. Department of 

Transportation (DOT) Type A quantities

• service or repair of gas chromatographs and X-ray fluorescent analyzers

• calibration of nuclear medicine/cardiology instruments using low-activity sources

• calibration of survey instruments and personnel dosimetry equipment using check or 

reference sources

• other low-risk services not identified above, where radioactive material is used for 

commercial service activities
1-2

HIGH RISK—Possession or use incidental to performing the following commercial services 

utilizing unsealed or uncontained radioactive material, and high-activity radioactive 

sealed sources:

• service or repair of portable nuclear gauges (including removal of source rod)

• service or repair of fixed gauges

• service or repair of fixed gauges mounted on a mobile object such as a truck or railcar

• storage of radioactive material for other entities

• use of unsealed material in tracer studies (example: use inside pipes in a refinery)

• use of remote activated robotics in radioactive contaminated areas

• calibration of survey instruments and personnel dosimetry equipment as a service 

for others

• installation; radiation surveys; routine and preventive maintenance; adjustment or repair 

of high dose rate (HDR) remote afterloaders, teletherapy, or gamma stereotactic 

radiosurgery units that require access to the sealed source(s), driving units, or other 

electronic components that could expose the sealed source, reduce the shielding, or 

compromise the radiation safety of the device or safety systems

• installation, relocation, removal from service, disposal, radiation surveys, routine or 

preventive maintenance, adjustment, training or repair of

— self-shielded irradiators [American National Standards Institute (ANSI) Category I 

irradiators]

— Title 10 of the Code of Federal Regulations (10 CFR) Part 36, “License and 

Radiation Safety Requirements for Irradiators,” (ANSI Categories II, III, and 

IV irradiators)

• nuclear laundry services

• retrieval of industrial radiography sealed sources

• decontamination and decommissioning services (NUREG–1757, Volume 1)

• packaging for shipment of radioactive materials, including the use of DOT 

Type B Packages

• waste management services including: packaging and repackaging of radioactive waste 

for transportation, commercial incineration, compaction, super compaction, solidification,

or vitrification

• other high-risk services not identified above, excluding activities involving critical mass 

quantities of special nuclear material
1-3

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

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

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

requirements in 10 CFR Part 20, “Standards for Protection against Radiation,” and 10 CFR 

Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct Material,” and 

NRC Form 313 have been approved under OMB Clearance Nos. 3150-0014, 3150-0017, and 

3150-0120, respectively.

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(s), 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 necessary for each item on NRC 

Form 313.

NRC Form 313 does not provide sufficient space for applicants to include 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 of applicants and for streamlined handling of applications for service provider 

licenses, Appendix B, “Suggested Format for Providing Information Requested in Items 5 

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

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

effective dose equivalent, committed dose equivalent, committed effective dose 

equivalent, or total effective dose equivalent (TEDE), as defined terms in 10 CFR Part 20. 

Roentgen equivalent man (rem) and its International System of Units equivalent, sievert (Sv) 

{1 rem =[ 0.01 Sv]}, are used to describe units of radiation exposure or dose. This is done 

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

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
2-2

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 

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 (SA) 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 Title 10 of the Code of Federal 

Regulations (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, which NRC usually evaluates on a case-by-case basis.) Individuals or 

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

status for specific AEA radioactive materials they intend to possess or use.
2-3

Table 2-1. Who Regulates the Activity?

Applicant and Proposed Location of Work Regulatory Agency

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

subject to exclusive Federal jurisdiction

Agreement State4

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

to exclusive Federal jurisdiction

NRC

Non-Federal entity in Agreement State using radioactive materials 

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

52 reactor operations or needed during the construction and 

preoperational phases of a reactor.

NRC

Non-Federal entity in Agreement State using radioactive materials not

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

needed during the construction and preoperational phases of a reactor.

Agreement State4

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.

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 of this NUREG). 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).”

3-1

3 MANAGEMENT RESPONSIBILITY

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

radiation safety programs 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.

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 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, including 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, 10 CFR 40.9, and 10 CFR 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 (DOT)

regulations and 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

• 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, 10 CFR 40.7, and 10 CFR 70.7, “Employee protection”)

• commitment to provide information to employees about deliberate misconduct provisions 

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

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

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

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

following the filing of a 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. 

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 the 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, the NRC’s 

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

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

programs. For instance, service providers following operating and emergency procedures to 

ensure that activities are conducted safely may be taking actions that correspond 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). These procedures allow the service provider 

to focus on the high-risk processes, while performing the maintenance activities to maintain 

safety. 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 N 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 service providers. 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 51 “Environmental Protection Regulations for Domestic Licensing and

Related Regulatory Functions”

• 10 CFR Part 61 “Licensing Requirements for Land Disposal of Radioactive Waste”

• 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”
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• 10 CFR Part 150 “Exemptions and Continued Regulatory Authority in Agreement

States and in Offshore Waters under Section 274”

• 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”

• 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 the above documents may be obtained by calling the Government Publishing Office 

order desk toll-free at 866-512-1800; in Washington, DC, at 202-512-1800; or 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

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”). 

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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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 by 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 an 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”).

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’s (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 below, 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 O of this NUREG includes a 

checklist for requests for withholding 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 (IN) 

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, 

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

• Security-Related Information: Following the events of September 11, 2001, 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—Withhold under 10 CFR 2.390.” For the pages having securityrelated 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, “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 22, 2005, which can be 

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

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

information on procedures and any updates is available at https://www.nrc.gov/readingrm/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 intragency 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, or 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 at https://www.nrc.gov/readingrm/doc-collections/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 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 at

https://www.nrc.gov/reading-rm/doc-collections/management-directives/.
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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, licensees that qualify as “small entities” 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, MD, 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.

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8 CONTENTS OF AN APPLICATION

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

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

All items in the application should be completed in enough detail for the 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, Rev. 2, “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.

After an application for service provider authority has been reviewed by the NRC staff and 

found to be generally complete and responsive to NRC Form 313 (Appendix A of this NUREG) 

and this guidance, a pre-licensing visit may be scheduled by the NRC at the licensee’s facility. 

A visit or conference may also be scheduled as part of the license renewal process. A 

pre-licensing visit provides the NRC staff with an opportunity to better evaluate the proposed 

program. The pre-licensing visit also provides the NRC staff an opportunity to meet with 

licensee management and others responsible for the radiation protection program and stress 

the importance of their responsibilities under a broad license, as well as to discuss and agree 

on additional information and commitments that may be needed. 

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.

Item 1: License Action Type 

Item 1 of NRC Form 313 states the following:

This is an application for (check appropriate item):
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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 pre-licensing visit may be required prior to 

issuance of the license. Also note that an initial security visit may be conducted in accordance 

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

the license.

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

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

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

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 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”). 

Notification of Bankruptcy Proceedings

Regulations: 10 CFR 30.34(h), 10 CFR 40.41(f), 10 CFR 70.32(a)

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 be notified 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 the NRC’s interests in the bankruptcy proceeding.
8-3

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.”

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

Possessed 

“Permanent Location” 

With regard to areas where licensed materials are used or stored on a permanent basis, a 

“permanent location” may be:

• an individual building or facility at one address 

• a contiguous, licensee-controlled geographic area, such as a campus or licenseeowned/operated/controlled business campus or park

• a designated area at sea or on board a ship if it is a permanent jobsite

Note: A temporary jobsite is not considered a “permanent location.” 

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

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

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

facility location. A post office box address is not acceptable. In addition, applicants are 

encouraged to provide global positioning system coordinates, as appropriate.

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

address or location not already listed on the license.

Service providers who perform work activities at temporary jobsites should ensure that they are 

authorized to perform work at each location. To conduct operations at temporary jobsites 

(i.e., locations where work is conducted for limited periods of time), the address may be stated 

as “temporary jobsites anywhere in the United States where the NRC maintains jurisdiction.” 

See Table 2-1 to determine the appropriate regulatory jurisdiction.
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An acceptable location of use or possession specifies street address, city, 

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

Figure 8-1. Location of Use or Possession

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.

Note: As discussed in Section 8.5.3, “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.

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. Also include 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 in order to provide information 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. 

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

State, or local regulations (e.g., local zoning requirements).
8-5

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.

Item 5: Radioactive Material

Sealed Sources

Regulations: 10 CFR 30.3, 10 CFR 30.32(g), 10 CFR 31.5, 10 CFR 31.12, 10 CFR 32.210, 

10 CFR Part 37

Criteria: Applicants must provide the manufacturer’s name, model number, radionuclide, 

quantity, and nominal activity for each requested sealed source and manufacturer and 

model number for each device that they will possess, use, and service in accordance with 

10 CFR 30.32(g). Service provider licensees will be authorized to possess and use only 

those sealed sources and devices specifically approved or registered by NRC or an 

Agreement State.

Discussion: The NRC or an Agreement State performs safety evaluations of sealed sources 

and devices before authorizing manufacturers to distribute to licensees. This safety evaluation 

is documented in a Sealed Source and Device (SSD) registration certificate. 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 the NRC’s prior permission in a license amendment. Such 

changes may necessitate a custom registration review, increasing the time needed to process 

a licensing action. SSD registration certificates contain sections on “Conditions of Normal Use” 

and “Limitation and Other Considerations of Use.” These sections may include limitations 

derived from conditions imposed by the manufacturer or distributor, by particular conditions of 

use that would reduce the radiation safety of the device, or by circumstances unique to the 

sealed source or device. For example, the working life of the device, the appropriate 

temperature, and other environmental conditions may be specified. Except as specifically 

approved by the NRC, licensees are required to use sealed sources and devices according to 

their respective SSD registration certificates. Accordingly, applicants should obtain a copy of 

the certificate. Service providers, when possessing, using, or servicing sealed sources or 

devices, should consult with the manufacturer or distributor to ensure that requested sources 

and devices are compatible and conform to the SSD designations registered with NRC or an 

Agreement State.

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.
8-6

Figure 8-2. Examples of Sealed Sources or Devices Possessed, Used, or Serviced

Service providers who remove for disposal/transfer or dispose of fixed gauges at customer 

facilities may wish to perform this service for device models and sealed sources not 

specifically identified on their license. Specific authorization to provide these limited services 

for fixed gauges that are similar in design and activity to those listed on their license from 

other manufacturers will be included in the license.

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 8.10.11, “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:

• Identify each radionuclide that will be possessed in each SSD, and specify the 

maximum activity per source. Also, specify the maximum number of sources or the 

total activity for each radionuclide.

• Identify the manufacturer or distributor and model number of each type of sealed source 

and device requested, or provide SSD registration certificate number.

• Identify any depleted uranium that is used as shielding material, if applicable. If 

depleted uranium is used, specify the total amount in kilograms.

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

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

• Confirm that the activity per source and maximum activity per device will not exceed the 

maximum activity listed on the approved certificate of registration issued by the NRC or 

by an Agreement State.

• Identify the special circumstances under which sealed sources and devices that are not 

registered by the NRC or an Agreement State may be possessed, used, or serviced.
8-7

• If the applicant will not take possession of the sealed sources and devices, the 

applicant should make this statement in its application request.

Note: Licensees who are authorized to possess small quantities of material, below the 

Category 2 quantities described in Appendix A to 10 CFR Part 37 are not subject to access 

control and physical protection requirements described in 10 CFR Part 37. If applicants or 

licensees plan to service or acquire a Category 1 or Category 2 quantity, they should visit the 

NRC’s public Web site (www.nrc.gov) for additional information regarding access control and 

security program requirements for Category 1 and Category 2 licensed material. Please 

contact the appropriate regional office for questions regarding the security of licensed material. 

Reference: For more information about the SSD registration process, see the current version 

of NUREG–1556, Volume 3, “Consolidated Guidance About Materials Licenses: Applications 

for Sealed Source and Device Evaluation and Registration.” 

Unsealed Radioactive Material

Regulations: 10 CFR 30.32(i), 10 CFR 30.33, 10 CFR 40.31, 10 CFR 70.22

Criteria: The applicant must provide the name of the radionuclide(s), chemical form, and 

maximum possession limit that the applicant will possess, use, and service.

Discussion: The applicant should list each requested radionuclide by its element name and 

its mass number [e.g., carbon-14(C-14)] in item 5. In certain situations, the applicant may 

request authorization to possess and use any form of byproduct material with atomic numbers 

from 1 through 83. The name of the specific chemical compound that contains the radionuclide 

is not required. For volatile radioactive material, applicants should specify whether the 

requested radionuclides will be acquired in free (volatile) or bound (nonvolatile) form because 

additional safety precautions may be necessary when handling and using free form volatile 

material. For example, when requesting authorization to use tritium (H-3) or iodine-125 (I-125), 

the applicant should 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 should be specified.

Applicants requesting an authorization to use volatile radioactive material must provide 

appropriate facilities, engineering controls, and radiation safety procedures for handling of such 

material.

Note: Additional safety equipment and precautions may be necessary when handling and 

using unsealed free form volatile radioactive materials. Volatile means that a liquid, and in rare 

cases a solid, becomes a gas at a relatively low temperature when exposed to the 

environment.
8-8

Table 8-1. Types of Radioactive Materials

Type of Material

Covered by 

this NUREG Examples

Byproduct Yes H-3, C-14, Na-22, I-131, I-125, S-35, P32, P-33, Ca-45, Ni-63, Cd-109, Cs-137,

Co-57, Na-22, Cd-109, Tl-201, Ga-67

Source material Yes U, Th

Special nuclear material Yes Pu, U-233, uranium enriched in U-235

or U-233

Naturally occurring radioisotopes Yes Ra-226 (Discrete Sources)

Note: Authorization to possess byproduct materials with atomic numbers 84 through 96 does 

not include authorization to possess uranium, thorium, or plutonium. Even though these 

elements have atomic numbers within the range of 84 through 96, they are designated source 

or special nuclear material (SNM), not byproduct material, and should be requested 

individually. Quantities of SNM addressed in this guide are limited to small activities that 

cannot, under any circumstances, achieve critical mass configuration as defined in 

10 CFR 150.11.

The NRC has jurisdiction over discrete sources of radium (Ra)-226, accelerator-produced 

radioactive materials, and other discrete sources of naturally occurring radioactive material. 

See Energy Policy Act of 2005.

The anticipated possession limit in megabequerels (MBq) [millicuries (mCi)] or gigabequerels 

(GBq) [millicuries (mCi) or curies (Ci)] for each radionuclide must also be specified. 

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. 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 the 

section on Financial Assurance and Decommissioning.

Response from Applicant: For each radionuclide, provide the element name with mass 

number, the chemical and physical form, and the maximum requested possession limit.

• For potentially volatile materials (e.g., I-125, I-131, H-3), specify whether the material 

will be free (volatile) or bound (nonvolatile) and the requested possession limit for each 

form.

• For 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 in accordance with 

10 CFR 30.32(i),:

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

radioactive materials would not exceed 0.01 sievert (Sv) [1 rem] effective dose 

equivalent or 0.05 Sv [5 rem] to the thyroid; or
8-9

— an emergency plan for responding to the release of radioactive material in 

accordance with the criteria listed in 10 CFR 30.32(i)(3)

• For source material, specify the number of kilograms and the activity of natural uranium, 

depleted uranium, and thorium requested.

• For SNM, specify the number of grams of material, the activity requested for each 

isotope, the percent enrichment, and specify whether the material will be free (volatile) 

or bound (nonvolatile). 

• If the applicant will not take possession of the unsealed radioactive material, the 

applicant should make this statement in its application request.

Recordkeeping for Decommissioning

Regulations: 10 CFR 30.34, 10 CFR 30.35, 10 CFR 30.36, 10 CFR 30.51, 10 CFR 40.36(f), 

10 CFR 40.46, 10 CFR 40.61, 10 CFR 70.25(g), 10 CFR 70.36, 10 CFR 70.51

Criteria: In accordance with 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g), all 

licensees must maintain records of structures and equipment where licensed materials are 

used or stored at locations specifically listed in the license. Also pursuant to 10 CFR 30.35(g), 

10 CFR 40.36(f), and 10 CFR 70.51(b), respectively, licensees must transfer records important 

to decommissioning to the new proposed 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, 

respectively. 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) to the appropriate 

NRC regional office.

Discussion: Decommissioning requirements are intended to ensure that decommissioning will 

be carried out minimizing the impact on the public, maximizing occupational health and safety, 

and maximizing protection of the environment. 

In accordance with 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g), all licensees 

must maintain records of structures and equipment where licensed materials are used or 

stored at locations specifically listed in the license until the site is released for unrestricted use. 

As-built drawings (not blueprints) with modifications of structures and equipment shown, as 

appropriate, fulfill this requirement. If drawings are not available, licensees may substitute 

appropriate records concerning the areas and locations where licensed materials are used. In 

addition, if licensees have experienced unusual occurrences (e.g., leaking sources or other 

incidents that involve the spread of contamination), they must maintain records about 

contamination that remains after cleanup or contamination that may have spread to 

inaccessible areas. Under NRC regulations when terminating the license, licensees must 

transfer records important to decommissioning to either of the following:

• the new licensee before licensed activities are transferred or assigned

[10 CFR 30.35(g), 10 CFR 30.51(e), 10 CFR 40.36(f), 10 CFR 40.61(e), and 

10 CFR 70.51(b)]

• the appropriate NRC regional office before the license is terminated [10 CFR 30.51(f), 

10 CFR 40.61(f), and 10 CFR 70.51(a)]
8-10

Decommissioning records described above are not required for temporary jobsite locations.

In accordance with 10 CFR 30.36(d)(3), licensees must begin decommissioning if no principal 

activities under the license have been conducted for 24 months. Service provider licensees 

who store or possess radioactive material must comply with the “decommissioning timeliness 

rule” in 10 CFR 30.36(d). The intent of 10 CFR 30.36(d) is to prevent delays in

decommissioning and site cleanup. Service provider licensees should request an alternate 

schedule for decommissioning if no radioactive materials are used or stored at the location of 

use for 24 months. This request will be evaluated on a case-by-case basis to determine the 

activities that have been conducted at the facility and the extent of decommissioning activities 

needed, if any. Refer to Sections 2.2 and 2.6 of NUREG–1757, Volume 3, “Consolidated 

Decommissioning Guidance: Financial Assurance, Recordkeeping and Timeliness,” for 

guidance on what needs to be provided and the criteria the NRC will use to review a licensee’s 

request for an alternate schedule.

Response from Applicant: 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 drawings and records important to decommissioning and will transfer these records to 

an NRC or Agreement State licensee before licensed activities are transferred. 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 or to assign the 

records to the appropriate NRC regional office before the license is terminated.”

Financial Assurance

Regulations: 10 CFR 30.34(b), 10 CFR 30.35, 10 CFR 40.36, 10 CFR 40.46, 10 CFR 70.25,

10 CFR 70.36

Criteria: Financial assurance is not required for many service providers. A service provider 

who will be authorized to possess licensed material in excess of the limits specified in 

10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25, “Financial assurance and recordkeeping for 

decommissioning,” must provide evidence of financial assurance for decommissioning. 

Discussion: The NRC’s regulations are intended to ensure that decommissioning will be 

carried out so as to minimize the impact on the public, maximize occupational health and 

safety, and maximize protection of the environment. The requirements for financial assurance 

are specific to the types and quantities of byproduct material authorized on a license. 

NRC regulations requiring a certification of financial assurance (FA) or a decommissioning 

funding plan (DFP) are designed to provide reasonable assurance that the technical and

environmental components of decommissioning are carried out and unrestricted use of the 

facilities is possible at the conclusion or termination of licensed activities. These requirements, 

if applicable, specify that a licensee must 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 a certification of FA or a DFP when the possession of radioactive material 

with a half-life (T1/2) greater than 120 days exceeds certain limits. Criteria for determining if an 

applicant is required to submit a DFP or has the 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, all entitled, 

“Financial assurance and recordkeeping for decommissioning.” A DFP contains a site-specific 
8-11

cost estimate and a certification of FA. An FA certification includes a certification that the 

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

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

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

on the information to be provided for establishing FA for decommissioning and a standard 

format for presenting the information. Note that FA is required for four types of licensed 

materials: unsealed byproduct material (10 CFR 30.35); sealed byproduct material 

(10 CFR 30.35); dispersible source material (10 CFR 40.36); and unsealed special nuclear 

material (10 CFR 70.25). The total amount of FA required is the sum of the FA required for 

each of these types of materials. The regulations no longer allow escrow accounts or lines of 

credit. The regulations also require that any licensee that does not use the prepayment option 

as its financial assurance instrument must have a standby trust fund to receive any funds from 

the licensee for decommissioning because the NRC cannot receive funds directly.

For radiation waste broker service providers, 10 CFR 30.35(c)(5) requires that waste collectors 

and waste processors, as defined in 10 CFR Part 20, Appendix G, must provide financial 

assurance in an amount based on a decommissioning funding plan. The DFP must include the 

cost of disposal of the maximum amount (curies) of radioactive material permitted by license 

and the cost of disposal of the maximum quantity, by volume, of radioactive material that could 

be present at the licensee's facility at any time, in addition to the cost to remediate the 

licensee’s site to meet the license termination criteria of 10 CFR Part 20. 

Response from Applicant: 

Financial assurance is not required for most service provider applicants. 

If the applicant is going to possess radioactive material but wants to keep the possession limits 

below the requirements for financial assurance, applicants should provide a statement that,

“We shall restrict the possession of licensed material to quantities below the minimum limit 

specified in 10 CFR 30.35(d), 10 CFR 40.36(b), and 10 CFR 70.25(d), for establishing 

decommissioning financial assurance.”

OR

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

guidance in NUREG–1757, Volume 3.

Reference: NUREG–1757, Volume 3, Rev. 1, “Consolidated Decommissioning Guidance: 

Financial Assurance, Recordkeeping and Timeliness.” 

Emergency Plan

Regulations: 10 CFR 30.32(i), 10 CFR 30.72

Criteria: Applicants who will be authorized to possess radioactive material 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,” must prepare for 

the potential release of radioactive material.
8-12

Discussion: When requesting authorization for possession limits in excess of the quantities 

listed in Schedule C of 10 CFR 30.72, the applicant must provide, in conjunction with the 

license application, either: 

• an evaluation showing that the maximum off-site dose due to 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 of radioactive materials in accordance 

with the criteria listed in 10 CFR 30.32(i)(3). 

Response from Applicant: 

If an emergency plan is required per 10 CFR 30.32(i), applicant must provide either:

An evaluation showing that the maximum off-site dose due to 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 that contains the information specified in 10 

CFR 30.32(i)(3). 

Reference: Regulatory Guide 3.67, Revision 1, “Standard Format and Content for Emergency 

Plans for Fuel Cycle and Materials Facilities.” (ADAMS Accession No. ML103360487)

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

Regulations: 10 CFR 30.32 (d); 10 CFR 30.33(a)(1), 10 CFR 40.31(d), 10 CFR 51.21,

10 CFR 70.22(a)(2); 10 CFR 70.23(a)(1).

Criteria: Applicants must provide a basis for confidence that radioactive materials will be used 

as specified on a license. The variety of uses described in Chapter 1,” Purpose of Report,” are 

delineated into low or high-risk activities. An application for a license will be approved if the 

proposed activity is authorized by the Atomic Energy Act of 1954, as amended, and devices 

will be used only for the purposes for which they were designed and according to the 

manufacturer’s and distributor’s recommendations and instructions for use, as specified in an 

approved SSD registration certificate, unless otherwise authorized in the license. Use of 

sealed sources and devices other than those listed in the SSD registration certificate require 

review and approval by the NRC or an Agreement State.

Discussion: In the interest of national security and the protection of the public health and 

safety, and in order to provide a basis for confidence that new applicants will use licensed 

material as specified in a license, the NRC has changed its policy for processing applications 

for new licenses. All new applicants for NRC licenses may now be subject to a pre-licensing 

site visit. The purpose of the visit is to verify the content of the application and that licensed 

material will be used as specified on the license.

Use of licensed materials in tracer studies: If the material will be used in tracer and field 

studies in which licensed material is deliberately released into the environment, an 

environmental assessment (EA) may be needed, according to 10 CFR 51.21, “Criteria for and 
8-13

Identification of Licensing and Regulatory Actions Requiring Environmental Assessments.” 

NUREG–1748, “Environmental Review Guidance for Licensing Actions Associated with 

NMSS Programs,” addresses procedures that staff should use in conducting environmental 

reviews, and is available on the NRC Web site under “Document Collections.” Memoranda 

dated March 19, 2004 (ADAMS Accession No. ML040790751) and October 20, 2009 

(ADAMS Accession No. ML092321078), provide further guidance. Applicants for tracer or field 

studies must provide the NRC with a description of the study for review and approval before 

performing such studies.

Applicants should note that authorization from the NRC to use licensed material in tracer 

studies does not relieve them of their responsibilities to comply with any other applicable 

Federal, State or local regulatory requirements.

If the licensed material will remain at the customer’s facility (and the customer does not 

maintain an NRC license) and the material is an exempt concentration in accordance with 

10 CFR 30.70, “Schedule A—Exempt concentration,” the applicant should contact the NRC to 

determine if an Exempt-Distribution license would be required. Applicants can refer to the 

guidance in NUREG–1556, Volume 8, “Consolidated Guidance About Materials Licenses:

Program-Specific Guidance About Exempt Distribution Licenses.”

Response from Applicant: In accordance with 10 CFR 30.32(d), 10 CFR 40.31(d) and 

10 CFR 70.22(a)(2), the service provider must specify the purpose for which each radioisotope 

or sealed source listed in Item 5 is to be used or possessed incident to providing a specific 

service. The service provider must also specify the specific services that will be provided. 

Refer to Appendix B, “Suggested Format for Providing Information Requested in Items 5-11 of 

NRC Form 313” of this NUREG for additional guidance.

AND

If the applicant wants to perform field studies in which licensed material is deliberately released 

to the environment, the following information should be provided:

• a complete application describing the type and amount of material to be used, the 

location of use, and training and experience of the individual using the material

• a copy of the applicant’s operating and emergency procedures

• a description of the amount of radioactive material to be released in the field, 

decontamination procedures at the conclusion of the experiment, if appropriate, and 

procedures for minimizing releases

• a description of the expected radiation dose to humans

• a sample agreement letter between the applicant and the applicant’s customer 

acknowledging the use of radioactive materials at the customer’s site

• a letter from the appropriate State health authorities indicating that they have reviewed 

the applicant’s application and concur with the applicant’s request
8-14

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

Their Training and Experience

Radiation Safety Officer (RSO)

Regulations: 10 CFR 30.33(a)(3), 10 CFR 40.32(b), 10 CFR 70.22(a)(6)

Criteria: Radiation Safety Officers (RSOs) must be qualified by training and experience in 

radiation protection and be available for advice and assistance on radiological safety matters. 

The RSO’s training and experience must be commensurate with the requested licensed 

material to be identified on the license. The RSO is typically the first responder for all 

radiological emergencies.

Discussion: The person responsible for the radiation protection program is the RSO. The 

RSO must also be responsible for compliance with the regulations for the use of radioactive 

material, which may include byproduct, source, and special nuclear material. The RSO must 

ensure that radiation safety activities are being performed safely according to approved policies 

and procedures and that all regulatory requirements are met. The RSO should have full 

access to all activities involving the use of licensed material and the authority to terminate any 

activity in which health and safety appear to be compromised without consulting with 

executive management.

The RSO’s duties and responsibilities include ensuring radiological safety and compliance

with NRC and the DOT regulations and the conditions of the license (see Appendix C of 

this NUREG).

The responsibilities of the RSO may not be transferred to other individuals. Many tasks and 

duties associated with managing the program may be assigned or delegated to other qualified 

individuals; however, the responsibility for these tasks and duties remains with the RSO. The 

NRC recognizes that a qualified individual will on occasion fill in for the RSO when the RSO is 

away for short periods of time (e.g., professional conferences, vacation, illness). Absences 

that have a major impact on licensed activities should not occur for extended or indefinite 

periods of time. Consideration should be given to how individuals temporarily delegated the 

duties and tasks of the absent RSO could contact the RSO in the event of an emergency.

When management selects an RSO, they should keep in mind the duties and responsibilities of 

the position, and select an individual who is qualified to serve as the RSO. The RSO will need 

a basic technical knowledge sufficient to understand, in general, the majority of the work being 

done with licensed materials under his or her responsibility. The individual selected as RSO 

must have sufficient training and experience to perform the duties required by his or her 

position. Executive management should ensure that the RSO has sufficient time allocated to 

carry out the responsibilities of the position. 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 identified and that the named individual knows of his or her designation as RSO. 

Appendix C 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.
8-15

Response from Applicant: 

• Provide the name of the proposed RSO who will be responsible for ensuring that 

the licensee’s radiation safety program is implemented in accordance with 

approved procedures.

AND

• Demonstrate that the RSO has sufficient independence and direct communication with 

responsible management officials by providing a copy of an organizational chart by 

position and demonstrating day-to-day oversight of the radiation safety activities.

AND

• Confirm that the RSO will be available for emergencies and can be on-site within 

24–48 hours, if applicable.

AND

• Provide the specific training and experience of the RSO, and include the specific dates 

of training in radiation safety.

OR

• Provide alternative information demonstrating that the proposed RSO is qualified by 

training and experience (e.g., Board Certification by the American Board of Health 

Physicists, completion of a bachelor’s and/or master’s degree in the sciences with at 

least 1 year of experience in the conduct of a radiation safety program of comparable 

size and scope).

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

designation of the RSO listed on the license.

Authorized Users and Radiation Workers

Regulations: 10 CFR 19.11, 10 CFR 19.12, 10 CFR 19.13, 10 CFR 30.33(a)(3),

10 CFR 30.34(e), 10 CFR 40.32, 10 CFR 70.22

Criteria: Individuals must receive instruction commensurate with their duties and 

responsibilities, as required by 10 CFR 19.12, “Instruction to workers,” for individuals whose 

assigned duties involve exposure to radiation or radioactive material, and individuals who in the 

course of their employment are likely to receive in a year an occupational dose of radiation 

greater than 1 millisievert (mSv) [100 millirem (mrem)]. 

Discussion: Authorized users (AUs) and radiation workers must have adequate training and 

experience to use, possess, or provide services involving licensed materials. An individual

named as an AU on an NRC license is responsible for ensuring that radioactive materials are 

handled and used safely and in accordance with NRC regulations and the terms and conditions 

of the NRC license. 
8-16

Duration of training and experience should be commensurate with the expected hazards that 

service provider personnel may encounter during routine and emergency conditions. 

Successful completion of training as described in Appendix D of this NUREG is evidence of 

adequate training and experience. Experience requirements could consist of on-the-job 

training completed under the supervision of a qualified individual [AU, RSO, or manufacturer’s 

representative that is authorized by the NRC or an Agreement State for the purpose(s) or 

activities that will be authorized in the license, when issued].

An AU is a person whose training and experience meet NRC criteria specified in Appendix D of 

this NUREG, who is named either explicitly or implicitly on the license, and who uses or directly 

supervises the use of licensed materials. An AU must ensure the proper use of licensed 

materials possessed under the license. AUs must have training to provide reasonable 

assurance that they will use, possess, or provide services involving licensed materials in a safe 

manner, maintain security, prevent unauthorized access, and respond appropriately to 

emergencies. AUs are responsible for the use of material by radiation workers. Applicants 

who want to provide radiation safety training involving the use of licensed material as a service 

to their customers should provide to the NRC for review a description of the training program 

that corresponds to the appropriate NUREG–1556 volume, to include radiation safety topics, 

frequency and duration of training, testing methodology, and qualification of course instructors. 

The NRC will review such requests to determine that the radiation safety aspect of the use of 

licensed material during hands-on training is adequate to protect occupational workers and 

members of the public.

Service providers should not assume that safety instruction has been adequately covered by 

previous radiation safety training. Particular attention should be given to individuals performing 

work or in the immediate vicinity or work being performed with radioactive materials that may 

require special procedures (e.g., sealed source exchange, service operations that create high 

radiation areas). Training may be in the form of lecture, demonstrations, videotape, or selfstudy and should emphasize practical subjects important to the safe use of licensed material. 

Emergency drills should be conducted on the likely scenarios a service provider may 

encounter. The guidance in Appendix D of this NUREG may be used to develop a training 

program. The program should consider both the topics pertinent for each group of workers and 

the method and frequency of training.

Response from Applicant: 

Applicants provide either of the following:

• A statement that: “Before using licensed material, authorized users will receive the 

training described in Appendix D in NUREG–1556, Volume 18, Revision 1, 

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

Service Provider Licenses.’”

OR

• A description of the training and experience for proposed AUs.

AND

• A description of the radiation safety training involving the use of licensed material that 

will be provided as a service to customers, if training is provided by the service provider.
8-17

Note: Alternative responses will be evaluated using the guidance in this section.

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 40.9,

10 CFR 40.32(b), 10 CFR 40.41(e), 10 CFR 70.9, 10 CFR 70.23(a)(2), 10 CFR 70.32(b)

Criteria: Ancillary personnel may include clerical, housekeeping, security, any customers’ 

personnel or licensee staff members working under the supervision and direction of the service 

provider’s RSO or AU at the time licensed materials are possessed (incident to providing 

services) under the service provider’s license, and other similar types of personnel whose 

duties may require them to work in the vicinity of radioactive material, whether they are 

escorted or not by AUs. These individuals should be informed about radiation hazards and the 

appropriate precautions they should take when working in the vicinity of licensed material. The 

licensee should assess each individual’s involvement with licensed material and provide 

appropriate training.

Discussion: Ancillary personnel must receive radiation safety training commensurate with 

their duties. Each individual should also receive periodic refresher training.

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

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

Response from Applicant:

Provide either of the following:

• A statement that: “Before working in the vicinity of licensed materials, personnel will 

have successfully completed training commensurate with assigned duties.”

OR

• 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 refresher training.

Item 9: Facilities and Equipment 

Regulations: 10 CFR 20.1101(b), 10 CFR 20.1406, 10 CFR 30.33, 10 CFR 30.33(a)(2 and 5),

10 CFR 30.35(g), 10 CFR Part 37, 10 CFR 40.32(c), 10 CFR 51.20, 10 CFR 51.21,

10 CFR 70.23(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 materials, as defined in 

10 CFR 37.5. Additionally, they must minimize the possibility of contamination, and keep 

exposure to occupationally exposed workers and the public ALARA.
8-18

Discussion: Applicants who will never take possession of licensed material, but require a 

license to perform work with the licensed material at their client’s facilities, will not need to 

provide detailed information regarding their facilities, but should confirm that they will not take 

possession of radioactive materials.

Applicants who will possess licensed material at their facilities must demonstrate that proposed 

facilities and equipment provide adequate storage capabilities, appropriate shielding, maintain 

radiation exposures ALARA, and minimize the possibility of contamination or release of 

licensed materials, as a result of normal and emergency conditions, including fire, floods, 

earthquakes, and wind damage. Licensed materials located in an unrestricted area and not in 

storage must be under the constant surveillance and immediate control of the licensee. 

Licensed materials should be accessible only by authorized persons and secured or locked 

when an authorized person is not physically present. If accessible by unescorted, 

unauthorized persons, use or storage areas cannot be considered restricted areas for 

purposes of radiation safety.

Applicants may elect to delay completing permanent facilities that will be specifically listed on 

its license and acquiring equipment described in the application until the technical review of the 

application is completed by the licensing staff and the license is issued. Delaying the 

acquisition of certain equipment or modifications to the permanent facility allows for changes 

identified as a result of the technical review of the application to be implemented.

In all cases, the applicant cannot 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.
8-19

In accordance with 10 CFR Part 37, any licensee that possesses an aggregated Category 1 or 

Category 2 quantity of radioactive material must, among other things,

• implement the physical protection requirements in 10 CFR Part 37 for material in use 

and storage, at both permanent and temporary jobsites; and

• in accordance with 10 CFR 37.49, be able to monitor, detect without delay, assess, and 

respond to any unauthorized entries into security zones, including those surrounding 

mobile devices, and immediately detect any unauthorized removal of Category 1 

quantities of radioactive material from the security zone. (Monitoring and detection 

systems may include, among other methods, monitored video surveillance systems and 

electronic devices for intrusion detection alarms.)

• for mobile devices containing Category 1 or Category 2 quantities of radioactive 

material, have two independent physical controls to secure the material from 

unauthorized removal when the device is not under direct control and constant 

surveillance in accordance with 10 CFR 37.53. “Mobile device” is defined in 10 CFR 

37.5

For additional guidance on implementing 10 CFR Part 37 requirements, see NUREG-2155, 

“Implementation Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.”” Additional information regarding best 

practices for protection of risk-significant radioactive material is available in NUREG-2166, 

“Physical Security Best Practices for the Protection of Risk-Significant Radioactive Material.”

Please note, under 10 CFR Part 37, security plans are not submitted to the NRC, but may 

be subject to review and inspection.

Response from Applicant:

For guidance on which activities are considered low-risk and which are high risk, please refer 

to Chapter 1, “Purpose of the Report.”

Service providers listed in the low-risk group (e.g., leak test, environmental sample analysis) 

only need to provide the location where these services will be performed. Indicate if services 

will be performed at temporary jobsites. No facility description is required. These applicants do 

not need to provide the additional information required of high-risk service providers

listed below. 

For those services listed in the high-risk group who will have permanent facilities specifically 

identified on the license, provide the following information, as applicable to the service the 

applicant intends to perform:

• Submit a drawing or sketch of the proposed permanent facility that fulfills the 

following requirements:

— Identify area(s) assigned for the receipt, storage, security, preparation, handling, 

waste storage, and measurement of radioactive materials, including sealed 

sources and devices.
8-20

— Show the relationship and distance between restricted areas and adjacent 

unrestricted areas.

— Indicate the scale, or include dimensions on each drawing or sketch. The same 

scale should be used for all sketches and drawings. The recommended scale is 

1/4 inch = 1 foot. Drawings to this scale that do not fit on 8-1/2 × 11-inch paper 

may be provided as sectional drawings. Please also include a compass 

directional arrow to indicate “North.”

— Specify shielding materials (e.g., concrete, lead) and means for securing 

radioactive materials from unauthorized removal.

— Illustrate area(s) where explosive, flammable, or other hazardous materials may 

be stored.

— Identify area(s) where radioactive materials may become airborne. The diagram 

should contain descriptions of the ventilation systems, with pertinent airflow 

rates, filtration equipment, sample collection points, and monitoring systems.

— Identify specialized handling tools, facility safety interlocks designed to prevent 

operation of radiological safety systems in the event that operation of a system 

could result in accidental exposure or release of material [e.g., high efficiency 

particulate air (HEPA) filters, ventilation system, safety door interlocks, etc.] or 

equipment. 

— Identify radioactive waste handling equipment that includes, for example,

incinerators, compactors, solidification equipment, hold-up tanks, and sample 

collection points.

• In addition, describe:

— Engineered safety systems (e.g., area monitors, interlocks, alarms).

— Protective clothing (i.e., latex or rubber gloves, lab coats or coveralls, 

respirators, booties, and face shields), auxiliary shielding, absorbent materials, 

secondary containers for waste water storage for decontamination purposes, 

plastic bags for storing contaminated items, etc., that will be available for use 

when handling unsealed or uncontained radioactive materials.

— The general location of each proposed permanent facility (e.g., an industrial 

park, an office complex) and its current use. If any proposed permanent facility 

is a private residence, provide diagrams of the installation that include the 

building, the proposed restricted area or areas, and adjacent areas, including 

above and below the restricted areas; provide commitments that restricted areas 

do not include residential quarters, and explain how radiation levels in 

unrestricted areas will be maintained at less than 1 mSv [100 mrem] per year.

— The proposed nuclear laundry facilities, if applicable, used for contaminated 

protective equipment and clothing. Specify how the contaminated waste water 

from the laundry machines or sinks is disposed. Operating and emergency 

procedures should address decontamination of the laundry area and equipment.
8-21

Note: Mark drawings and diagrams that provide the exact location of materials, or 

depict specific locations of safety or security equipment as “Security-Related 

Information—Withhold under 10 CFR 2.390.”

For temporary jobsites:

• No facility description is required. (NOTE: equipment used at temporary jobsites will be 

discussed in Section 8.10.1 “Operating and Emergency Procedures”)

Item 10: Radiation Safety Program 

Regulations: 10 CFR 20.1101, 10 CFR 30.33, 10 CFR 40.32, 10 CFR 70.23

Criteria: A radiation safety program must be established and submitted to the NRC as part of 

the application. The program must be commensurate with the scope and extent of activities for 

the use of licensed materials in service operations.

Each applicant must develop, document, and implement a radiation protection program that is 

specific to its types of operations. Radiation safety programs should address the following 

elements:

• development, implementation, and maintenance of written operating and emergency 

procedures to address all likely situations

• development and implementation of an access authorization program, if required

• development and implementation of an ALARA program

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

the environment

• confirmation that licensed activities are conducted only by individuals qualified by 

training and experience

• description of organization structure and individuals responsible for ensuring day-to-day 

oversight of the radiation safety program

• establishment and management of a radiation safety and decommissioning 

records system

• implementation of an audit program to ensure that, at least annually, the radiation 

safety program is reviewed

• development of a sample agreement letter between the applicant and the applicant’s

customer acknowledging the use of radioactive materials at the customer’s site

• development and implementation of a program to ensure the security and control of 

licensed material

Discussion: The required components of the applicant’s radiation safety program are detailed 

in the following topics found in this NUREG. Some topics will not require the applicant to 
8-22

submit information as part of an application, but simply provide the applicant with guidance to 

comply with a specific NRC requirement.

Operating and Emergency Procedures

Regulations: 10 CFR 19.11(a)(3), 10 CFR 20.1101, 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 37.41, 10 CFR 37.45, 10 CFR 37.57, 

10 CFR 37.81, 10 CFR 40.41(e), 10 CFR 40.60, 10 CFR 70.32(b), 10 CFR 70.50

Criteria: As part of the application package, the licensee must develop, implement, and 

maintain operating and emergency procedures. Operating procedures for high-risk licensed 

activities (described in Chapter 1, “Purpose of the Report”) should be submitted with the 

application. Low-risk licensed activities do not require the submission of operating procedures. 

Emergency procedures should be submitted with all license applications and should address 

the important radiation safety aspects for the proposed activities and address all likely 

scenarios that may be encountered. 

Discussion: The purpose of operating and emergency procedures is to provide personnel 

specific guidance for all operations they will perform. The operating and emergency 

procedures should include each topic important to safe operation considered applicable to the 

materials and uses proposed in the application.

Each licensee must develop, implement, and maintain operating and emergency procedures 

for all likely scenarios that might be encountered. Emergency scenarios may include high dose 

rate alarm; leaking source; stuck source; radioactive spill; natural phenomena, such as fire, 

earthquake, and tornados; medical emergency; contaminated or injured individual; inhalation or 

ingestion due to aerosolized contamination; radiation overexposure; unshielded source; device 

malfunction; device toppled over or damaged; activation of a safety or security alarm; lost or 

missing radioactive material, and transportation accident involving the transport of licensed 

material. The operating and emergency procedures should include the items outlined below:

• Procedure for obtaining an agreement with customers outlining the responsibilities of 

both the customer and service provider, when performing service operations at a 

customer’s facility. The written agreement should include:

— description of roles and responsibilities of the service provider and the customer

— notice to the customer if the service provider will bring radioactive material into 

the customer’s facility 

— discussion on who will maintain security of the radioactive material 

(example: during comingling of multiple sources from multiple customers)

— discussion of who will take the lead for any emergency situations that might 

arise from this service call (e.g., spill, injured worker, overexposure, stuck 

source, leaking source, decontamination activities)
8-23

— indication if any aftermarket sources or parts will be used BEFORE servicing

— description of the authorized use of the customer’s calibrated radiation survey 

meter, if the need arises

• Instructions for handling and using licensed materials.

• Instructions for maintaining security during storage and transportation.

• Instructions to keep licensed material under control and immediate surveillance 

during use.

• Instructions for posting areas and labeling containers.

• Steps to take to keep radiation exposures ALARA.

• Steps to maintain accountability during use.

• Steps to control access to work sites.

• Steps to take and whom to contact when an emergency occurs.

• Instructions for using remote handling tools when handling sealed sources, except lowactivity calibration sources.

• Methods and occasions for conducting radiation surveys, including surveys for 

detecting contamination.

• Procedures to minimize personnel exposure during routine use and in the event of 

an incident, including exposures from inhalation and ingestion of licensed 

unsealed materials.

• Methods and occasions for locking and securing stored licensed materials.

• Procedures for personnel monitoring, including bioassays, and the use of personnel 

monitoring equipment.

• Procedures for transporting licensed materials to temporary jobsites, packaging of 

licensed materials for transport in vehicles (private or common carrier), placarding of 

vehicles when needed, and physically securing licensed materials in transport vehicles 

during transportation, to prevent accidental loss, tampering, or unauthorized removal.

• Procedures for picking up, receiving, and opening packages containing licensed 

materials, in accordance with 10 CFR 20.1906, “Procedures for receiving and 

opening packages.”

• Instructions for maintaining records, in accordance with the regulations and the 

license conditions.

• Procedures for identifying and reporting to the NRC defects and noncompliance, as 

required by 10 CFR 21.21(a).
8-24

• Procedures and actions to be taken in an emergency situation that will cover all likely 

scenarios, including actions to prevent the spread of contamination and minimize 

inhalation and ingestion of licensed materials and actions to obtain suitable radiation 

survey instruments.

• Instructions for the proper storage and disposal of radioactive waste.

• Procedures to be followed in the event of uncontrolled release of radioactive unsealed 

licensed material to the environment, including notification of the RSO, NRC, and other 

Federal and State agencies.

• Procedures for identifying and reporting to the NRC incident notifications (see Table 8-2

for a description of the typical incident notifications required by NRC regulations).

• Procedures for the implementation and adherence to good health physics practices 

while performing service operations, such as:

— minimization of distance to areas, to the extent practicable, where licensed 

materials are used and stored

— maximization of survey frequency, within reason, to enhance detection 

of contamination

— segregation of radioactive material in waste storage areas

— segregation of sealed sources and tracer materials to prevent 

cross-contamination

— separation of radioactive material from explosives

— separation of potentially contaminated areas from clean areas by barriers or 

other controls

• Method for reviewing the entire radiation safety program at least annually.

Written documentation of the procedures written above should be retained for review during 

inspection.

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.
8-25

Table 8-2. Regulatory Required Notifications

Typical NRC Notifications Required for Service Providers

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 final delivery 

carrier must be 

notified.)

None 10 CFR 20.1906(d)

Theft or loss of material Immediate Within 30 

days

10 CFR 

20.2201(a)(1)(i) &

(b)(1)

Whole body dose greater than 0.25 Sv 

[25 rem] per event

Immediate Within 30 

days

10 CFR 

20.2202(a)(1)(i)

10 CFR 20.2203(a)(1)

Extremity dose greater than 2.5 Gy

[250 rad]

Immediate Within 30 

days

10 CFR 

20.2202(a)(1)(iii)

10 CFR 20.2203(a)(1)

Whole body dose greater than 0.05 Sv 

[5 rem] in 24 hours

Within 24 hours Within 30 

days

10 CFR 

20.2202(b)(1)(i)

10 CFR 20.2203(a)(1)

Extremity dose greater than 0.5 Sv 

[50 rem] in 24 hours

Within 24 hours Within 30 

days

10 CFR 

20.2202(b)(1)(iii)

10 CFR 20.2203(a)(1)

Whole body dose greater than 0.05 Sv 

[5 rem] in a year

None Within 30 

days

10 CFR 

20.2203(a)(2)(i)

Dose to individual member of public 

greater than 1 mSv [100 mrems] in 

a year

None Within 30 

days

10 CFR 

20.2203(a)(2)(iv)

Defect in equipment that could create a 

substantial safety hazard

Within 2 days Within 

30 days

10 CFR 21.21(d)(3)(i)

& (ii)

Event that prevents immediate 

protective actions necessary to avoid 

exposure to radioactive materials that 

could exceed regulatory limits

Immediate Within 

30 days

10 CFR 

30.50(a)&(c)(2)
8-26

Table 8-2. Regulatory Required Notifications (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Unplanned contamination event that 

requires restricted access for more than 

24 hours and involves a quantity of 

material greater than five times the 

lowest annual limit on intake for the 

material as specified in Appendix B of 

10 CFR Part 20 and requires the area 

to be restricted for a reason other than 

to allow radionuclides with half-lives 

less than 24 hours to decay

24 hours 30 days 10 CFR 30.50(b)(1) & 

(c)(2); 40.60(b)(1) & 

(c)(2); and 70.50(b)(1) 

& (c)(2)

Equipment is disabled or fails to 

function as designed when required to 

prevent radiation exposure in excess of 

regulatory limits 

Within 24 hours Within 

30 days

10 CFR 30.50(b)(2) & 

(c)(2)

Unplanned fire or explosion that affects 

the integrity of any licensed material or 

device, container, or equipment with 

licensed material

Within 24 hours Within 

30 days

10 CFR 30.50(b)(4) & 

(c)(2)

Determination that any licensee that has 

not previously implemented the Security 

Orders (i.e., orders issued by the NRC to 

require licensees to implement interim 

security measures) or been subject to the 

provisions of 10 CFR Part 37, Subpart C 

will aggregate radioactive material to a 

quantity that equals or exceeds the 

Category 2 threshold

None 90 days 

before 

aggregating 

radioactive 

material to a 

quantity that 

equals or 

exceeds the 

Category 2 

threshold

10 CFR 37.41(a)(3)
8-27

Table 8-2. Regulatory Required Notifications (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Coordination with local law enforcement 

agency (LLEA) has failed, either because 

the LLEA has not responded or because 

the LLEA does not plan to participate

3 business days Submittal of a 

written report 

concerning 

failures of 

coordination 

with LLEA as 

described in 

10 CFR 

37.45(b) is not 

required; 

however, 

licensees 

must 

document 

their efforts to 

coordinate 

with the LLEA 

and keep this 

documentation 

for 3 years

10 CFR 37.45(b)&(c)

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)
8-28

Table 8-2. Regulatory Required Notifications (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

Determination that a shipment 

containing a Category 2 quantity of 

material is lost or missing in transport 

Within 4 hours 

of the 

determination, 

and again 

within 24 hours 

if the material 

has not yet 

been located 

and secured

30 days 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)

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)
8-29

Table 8-2. Regulatory Required Notifications (Continued)

Event

Telephone 

Notification

Written 

Report

Regulatory 

Requirement

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 301-951-0550, except as noted. The Center is staffed 24 hours a day and 

accepts collect calls.

Response from Applicant: Applicants who perform low-risk licensed activities are not 

required to submit operating procedures but should provide emergency procedures for all likely 

scenarios.

Applicants who perform high-risk licensed activities should submit their operating and 

emergency procedures for radiological conditions that might be encountered as part of their 

license application. Please note, under 10 CFR Part 37, security plans are not submitted to 

the NRC, but may be subject to review and inspection.

Note: Service providers who perform specific operations involving sealed sources, such as 

inspection and maintenance of devices, removal and replacement of sealed sources (source 

exchange), and operations that involve access to the sealed source(s) and safety systems, 

should include appropriate procedures and instructions for these operations in the applicant’s 

operating and emergency procedures. 

OR

Service providers should include operating and emergency procedures that are in accordance 

with the manufacturer’s and distributor’s procedures as well as the corresponding SSD

registration certificate for the devices that are being serviced or maintained.

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),

10 CFR 30.35(g), 10 CFR 30.41, 10 CFR 30.51, 10 CFR 31.11, 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 40.64, 10 CFR 70.25(g), 10 CFR 70.32(b), 10 CFR 70.42,

10 CFR 70.51,10 CFR 71.5, 10 CFR 71.47, 10 CFR 71.87
8-30

Criteria: Service provider licensees who will obtain and possess licensed material must do the 

following:

• Establish, maintain, and retain written procedures for safely opening packages

(10 CFR 20.1906).

• Secure and maintain accountability of licensed material (10 CFR 20.1801,

10 CFR 20.1802, 10 CFR Part 37).

• Maintain records of receipt, transfer, and disposal of licensed material

(10 CFR 20.2108, 10 CFR 30.51(a), 10 CFR 40.61(a), 10 CFR 70.51, 10 CFR Part 74).

• 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: Licensed radioactive material should only be ordered if it is authorized on the 

license. The radionuclide and chemical form should be commensurate with that listed on the 

license, and the activity should be within the prescribed license possession limit. Service 

Provider licensees who will obtain and possess licensed material are required to develop, 

implement, and maintain written procedures for safely receiving and opening packages, in 

accordance with 10 CFR 20.1906, “Procedure for receiving and opening packages.” Some 

packages containing licensed material may require special opening procedures, based on the 

types, quantities, or half-lives of the nuclide being delivered. Arrangements should be made to 

receive radioactive packages expeditiously when they are delivered to the permanent facility or 

at temporary jobsites at a customer’s facility that will receive packages. Alternatively, 

arrangements may be made for the applicant to be notified when radioactive packages arrive at 

the carrier’s terminal. 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 model procedure for safely 

opening packages containing licensed materials is included in Appendix E 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.
8-31

Licensed material becomes part of the licensee’s inventory at the time the licensee received 

the material, 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 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. 

Some packages may require special procedures that take into consideration the type, quantity, 

or half-life of the nuclide being delivered. 

Individuals that will receive packages containing licensed material 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. If the radioactive material 

is needed at a customer’s location and the package will be transported over public roads by 

the licensee, it must be repackaged and transported in accordance with DOT regulations

(see Appendix J of this NUREG) .

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 8-3, below.

Table 8-3. Package Monitoring Requirements (10 CFR 20.1906)

Package Contents Survey Type Survey Time*

Damaged Licensed Material Radiation Level

and Radioactive

Contamination

[20.1906(b)(3)]

As soon as practicable, 

but not later than 

3 hours after receipt of 

package

Labeled (White I, 

Yellow II, Yellow III)

Not Gas or 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
8-32

Table 8-3. Package Monitoring Requirements (10 CFR 20.1906)

Package Contents Survey Type Survey Time*

Labeled (White I, 

Yellow II, Yellow III)

Not Gas or Special Form

Less Than 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 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 

[§20.1906(c)].

 

†Type A Quantity means a quantity of radioactive material, the aggregate radioactivity of which does not exceed 

A1 for special form radioactive material, or A2, for normal form radioactive material, where A1 and A2 are given in 

Table A–1 of 10 CFR Part 71, or may be determined by procedures described in Appendix A of 10 CFR Part 71.

‡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 good health physics practices to 

perform an incoming survey on these packages, even though transportation regulations do not require it.

Regulations in 10 CFR 20.1906(d) require that the licensee immediately notify the final delivery 

carrier and the NRC Operations Center [301-816-5100], by telephone, when external radiation 

levels exceed the limits of 10 CFR 71.47, “External radiation standards for all packages” or 

removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i). The limits 

are (i) radiation levels exceeding 2 mSv/h [200 mrem/h] at any point on the external surface of 

the package; and (ii) removable radioactive surface contamination for beta/gamma emitters 

and low toxicity alpha emitters exceeding 4 Bq/cm2 [240 disintegrations per minute per 

centimeter squared (dpm per cm2

)], or for all other alpha emitters 0.4 Bq/cm2 [24 dpm/cm2] on 

the external surfaces of the package.

As illustrated in Figure 8-3, 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 ensure that the possession limits listed on the license are not exceeded.

Figure 8-3. Material Receipt and Accountability. Licensees must maintain records of

receipt, transfer, and disposal of licensed material.
8-33

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

material not in storage,” require licensees 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 not in storage. Applicants should establish policies and procedures for ensuring 

accountability of licensed materials.

Licensed material possessed at customer’s facilities may be received by the customer in 

advance of the service provider licensee performing services. In most circumstances, this 

material is received and possessed by the customer under the auspices of the customer’s 

license. Service provider licensees must have in place an accountability and control system for 

promptly detecting missing licensed material at permanent facilities, customer’s facilities, 

temporary jobsites, or any other locations where loss, theft, or misplacement of licensed 

material can occur. Operating and emergency procedures should address how the applicant

will maintain control and accountability of licensed material possessed incident to performing 

commercial services at customers’ facilities.

Licensees who possess Radioactive Material Subject to National Source Tracking 

System Requirements

Regulations in 10 CFR 20.2207, “Reports of transactions involving nationally tracked sources,” 

require that each licensee who manufactures, transfers, receives, disassembles, or disposes of 

a nationally tracked source must complete an National Source Tracking Transaction Report 

(NSTTR), in order to track high-risk radioactive sources from the time they are manufactured or

imported, through the time of their disposal or export, or until they decay enough to no longer 

be of concern.

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 National Source Tracking System (NSTS) in 

accordance with 10 CFR 20.2207. The regulations in 10 CFR 20.2207 require that each 

licensee that manufactures, transfers, receives, disassembles, or disposes of a nationally 

tracked source shall complete and submit a National Source Tracking Transaction Report 

(NSTTR) to the NRC. The NSTTRs are maintained in the NSTS, a secure computer system 

that tracks Category 1 and Category 2 nationally tracked sources from the time they are 

manufactured or imported through the time of their disposal or export, or until the source 

activity decays to below Category 2.

Inventory and Accountability of Radioactive Materials

Licensees who use or possess sealed sources are required by license condition to perform 

inventories of sealed sources every 6 months. Some sealed sources may not be in use or are 

rarely used and are placed in storage. In these cases, licensees should confirm that these 

sealed sources have not been removed from storage at least every 6 months. Licensees are 

also required by license condition to conduct leak tests of sealed sources at 6-month intervals 

(or at longer intervals, as specified in the SSD Registration Certificate). Because the 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, logbooks) 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, and radioactive decay. The chosen methods should 
8-34

ensure that possession limits are not exceeded. Licensees 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 licensee’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 periodically

update the total inventory of all unsealed materials possessed under the license. Depending 

on the 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 provided in 10 CFR 30.41, “Transfer of byproduct 

material.” Sample policy transfer statements are included in Appendix E of this NUREG. 

Transfer of licensed materials within the facility may require special procedures to ensure 

proper control. In many facilities, pieces of laboratory equipment or components, including 

refrigerators and freezers, will become contaminated. Removal of these items for 

maintenance, repair, or disposal should also be carefully controlled.

Licensees must maintain records of receipt, transfer, and disposal (as waste) of all licensed 

material, in accordance with 10 CFR 30.51(a); 10 CFR 40.61(a); and 10 CFR 70.51. Table 8-4

below lists each type of record and how long the record must be maintained. Records for the 

transfer of licensed material should include verification that the receiver is authorized to 

possess the licensed material being transferred in accordance with 10 CFR 30.41(c). Receipt 

records should also document cases where excessive radiation levels or radioactive 

contamination were found on packages or containers of material received and describe the 

action taken.

Lost Source Policy is the NRC’s policy that a civil penalty may be issued for violations 

resulting in regulated material being out of the control of the licensee, regardless of the use, 

license type, quantity, or type of regulated material (e.g., loss, abandonment, improper 

transfer, or improper disposal of regulated material).

Table 8-4. Record Maintenance

Type of Record How Long Record Must Be Maintained

Receipt For as long as the material is possessed and for 3 years 

following the transfer or disposal of the material.

Inventory For 5 years from the date of the inventory in accordance with 

license conditions

Transfer For 3 years after each transfer unless a specific requirement 

dictates otherwise

Disposal Until the 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.
8-35

Receipt, transfer, and disposal records must be maintained for the times specified in Table 8-4. 

Typically, these records contain the following types of information:

• radionuclide and activity (in units of becquerels or curies) of byproduct material in each 

sealed source

• manufacturer’s or distibutor’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 

performing the inventory

• for materials transferred or disposed of, the date of the transfer or disposal, the name 

and license number of the recipient, and description of the affected radioactive material 

(e.g., radionuclide, activity, manufacturer’s name and model number, serial number)

Licensed material possessed incident to performing services at customers’ facilities is not 

normally transferred to the service provider during the time service is being performed. One 

notable exception is when the service provider is preparing the shipment to be shipped and 

is designated as the shipper of record (i.e., signing the shipper’s certification on the 

shipping paper).

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:

Provide the following:

• A statement that: “We will develop, implement, and maintain procedures for ensuring

accountability of licensed materials at all times.”
8-36

AND

• If applicable, provided the following statement: “We will comply with the National Source 

Tracking System (NSTS) reporting requirements as described in 10 CFR 20.2207.”

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 5 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

— A description of the procedures for ensuring that no sealed sources have been 

lost, stolen, or misplaced.

Note: 

• Alternative responses will be evaluated using the guidance in this section.

• No response is needed from applicants for package opening procedures. Package 

opening procedures will be reviewed during NRC inspections.

References:

• NUREG–1516, “Management of Radioactive Material Safety Programs at Medical 

Facilities” (1997)

• National Council on Radiation Protection and Measurements (NCRP) Report No. 114, 

“Maintaining Radiation Protection Records,” (1992)1

• NCRP Report No. 105, “Radiation Protection For Medical and Allied Health Personnel,” 

(1989)

• NCRP Report No. 127, “Operational Radiation Safety Program,” (1998)

• NCRP Report No. 157, “Radiation Protection in Educational Institutions,” (2007) 

 

1Copies may be obtained from the National Council on Radiation Protection and Measurements, 

7910 Woodmont Ave., Suite 400, Bethesda, MD 20814-3095, or ordered electronically at http://www.ncrponline.org.
8-37

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)

Criteria: Licensees must possess and periodically calibrate 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.

Discussion: Licensees must ensure that an adequate number of calibrated radiation detection 

and measurement instruments are available to make radiation measurements. Licensees 

should ensure that when performing work at temporary jobsites, a backup calibrated instrument 

is readily available if the primary instrument becomes inoperable. Instruments should be 

calibrated periodically for the types of radiation being measured. In this document, survey 

instruments are defined as any device used to measure radiological conditions. Figure 8-4

illustrates some common survey instruments used for making contamination surveys and for

taking direct radiation measurements.

Figure 8-4. Examples of Portable Instruments
8-38

Service provider applications should include the following with regard to radiation monitoring 

instruments:

• criteria used in determining what radiation detection and monitoring equipment will be 

required for the type of measurement to be taken (e.g., count rate, dose rate)

• type of use

• number and availability of a sufficient quantity of calibrated radiation detection and 

measurement instruments, such as

— ion-chambers

— Geiger-Mueller detectors

— liquid scintillation counters

— pocket ionization chambers (PIC)

— alarming ratemeters

— area monitors

— air samplers

NRC regulations require that radiation monitoring devices used to determine compliance with 

regulatory requirements be calibrated periodically by the licensee. Radiation monitoring 

devices and personnel dosimetry devices (e.g., PIC, alarming ratemeters) should be calibrated 

at least annually (every 12 months), unless otherwise specified by regulation or license 

condition. Applicants or licensees seeking authorization to perform radiation monitoring 

instrument calibrations should submit procedures for review or commit to implementing the 

procedure in Appendix F of this NUREG. The licensee may wish to review available industry 

standards for calibration of instruments such as American National Standards Institute (ANSI) 

N323AB-2013, “American National Standard for Radiation Protection Instrumentation Test and 

Calibration, Portable Survey Instruments.” Regardless of whether an applicant is authorized to 

calibrate radiation survey meters or contracts 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).

Response from Applicant:

Provide one of the following:

• A description of the instrumentation (as outlined above) that will be used to perform 

required radiological surveys and a statement that, “We will use instruments that 

meet the radiation monitoring instrument specifications published in Appendix F of 

NUREG–1556, Volume 18, Revision 1, “Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About Service Provider Licenses.” We reserve 

the right to upgrade our survey instruments as necessary.”

OR

• A description of the instrumentation (as outlined above) that will be used to perform 

required radiological surveys and a statement that, “We will use instruments that 

meet the radiation monitoring instrument specifications published in Appendix F of 

NUREG–1556, Volume 18, Revision 1, “Consolidated Guidance About Materials 
8-39

Licenses: Program-Specific Guidance About Service Provider Licenses.” Additionally, 

we will implement the model radiation survey meter calibration program published in 

Appendix F of NUREG–1556, Volume 18, Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Service Provider Licenses.’ We 

reserve the right to upgrade our survey instruments as necessary.”

OR

• A description of alternative equipment or procedures for ensuring that appropriate 

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

calibration and calibration frequency of survey equipment will be performed. Include a

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

Note: Alternative responses will be reviewed using the guidance in this section.

Surveys

Regulations: 10 CFR 20.1101, 10 CFR 20.1301, 10 CFR 20.1406, 10 CFR 20.1501,

10 CFR 20.2103, 10 CFR 20.2203, 10 CFR 30.53, 10 CFR 40.63, 10 CFR 70.56

Criteria: 10 CFR 20.1501 and 10 CFR 20.2103 contain general survey and survey 

recordkeeping requirements. When designing facilities and developing procedures for the safe 

use of these facilities, licensees should consider how to minimize radioactive contamination 

during operation, decontamination and decommissioning efforts, and radioactive waste 

generation. Procedures should address contamination of subsurface soil, drains/piping, and 

other potentially contaminated, inaccessible areas. Records of surveys and leak-test results 

must be maintained.

Discussion: Surveys are defined as evaluations 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 8-5). 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, or gamma) and compared to the appropriate 

regulatory limits.
8-40

Figure 8-5. Types of Surveys

Types of Surveys

Radiation surveys are used to detect and evaluate contamination of

• facilities

• equipment

• personnel (during use, transfer, or disposal of licensed material) (See Figure 8-6)

• restricted and unrestricted areas

Under 10 CFR 20.1501(a), surveys are required, when it is reasonable under the 

circumstances, to evaluate a radiological hazard. Many different types of surveys may need 

to be performed due to the particular use of licensed materials. Typical surveys may include 

the following:

• Surveys for radioactive contamination that could be present on surfaces of floors, walls, 

laboratory furniture, 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 or ingestion of radioactive material or where licensed 

material is or could be released to unrestricted areas.

• Measurements of radioactive material concentrations in water that is allowed by 

regulation to be released to the environment or to the sanitary sewer.

• 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.
8-41

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. Refer to 

Appendix F of this NUREG for a listing of the types of radiation survey instruments available.

Ambient survey and routine contamination survey frequencies depend on the quantity and use 

of radioactive materials, as well as the specific facilities, equipment, and procedures that are 

designed to protect the worker and members of the public from external exposure to radiation. 

NRC regulations do not provide specific limits for surface contamination in restricted areas, 

only that ALARA considerations must prevail. Each applicant should propose and justify fixed 

and removable surface contamination limits allowable in a work area before decontamination is 

required.

Contamination Survey Frequency

Personnel working with, in, or around unsealed forms of radioactive material should survey for 

contamination. Contamination surveys should be conducted at a frequency appropriate to the 

types and quantities of radioactive materials in use. If the activity used is greater than or equal 

to the smallest annual limit of intake (ALI) (for either inhalation or ingestion), as identified in 

Figure 8-6. Personnel Surveys. Users of unsealed licensed material should check 

themselves for contamination (frisk) before leaving the laboratory or any area 

with potential contamination.

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, “Records of surveys.” Table 8-5 

contains suggested contamination survey frequencies, based on ALIs. The suggested 

frequency of surveys is based upon 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 8-5. Suggested Contamination Survey Frequency

< 0.1 ALI 0.1 ALI to < 1.0 ALI > 1.0 ALI

In Use Monthly Weekly Daily

Not in Use Every 6 Months Every 6 Months Every 6 Months
8-42

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 levels specified in NUREG–1757, ‘Consolidated 

Decommissioning Guidance,’ Volume 1 ‘Decommissioning Process for Materials Licensees’ 

and Volume 2 ‘Characterization, Survey, and Determination of Radiological Criteria’ and 

NUREG–1575 ‘Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)’, 

including Supplement 1, ‘Multi-Agency Radiation Survey and Assessment of Materials and 

Equipment Manual (MARSAME)’ for unrestricted use. When equipment or facilities that are 

potentially contaminated are to be released for unrestricted use, surveys should be completed 

to ensure that the dose rates are in compliance with current decommissioning guidance. 

Surface contamination surveys should be conducted for both removable and fixed 

contamination before equipment and facilities are released from restricted to unrestricted use in 

order to ensure that they meet current decommissioning limits. The following NRC documents 

provide guidance on unrestricted use release criteria:

NUREG–1757, “Consolidated Decommissioning Guidance,” has three volumes that address 

the following topics:

Volume 1: “Decommissioning Process for Materials Licensees,” Revision 2, 

(ADAMS Accession No. ML063000243)

Volume 2: “Characterization, Survey, and Determination of Radiological Criteria,”

Revision 1, (ADAMS Accession No. ML06300252)

Volume 3: “Financial Assurance, Recordkeeping, and Timeliness, Revision 1, 

(ADAMS Accession No. ML12048A683)

Volume 2 of NUREG–1757 provides guidance on compliance with the radiological criteria for 

license termination in 10 CFR Part 20, Subpart E, using a screening approach dose analysis. 

Volume 2 contains acceptable license termination screening values of common 

radionuclides for building-surface contamination, as well as screening values for soil 

contaminated with radionuclides. 

NUREG–1575, Revision 1, “Multi-Agency Radiation Survey and Site Investigation 

Manual (MARSSIM),” provides detailed guidance for planning, implementing, and 

evaluating environmental and facility radiological surveys conducted to demonstrate 

compliance with a dose- or risk-based regulation. The MARSSIM guidance focuses on 

the demonstration of compliance during the final status survey following scoping, 

characterization, and any necessary remedial actions. NUREG 1575 can be found under 

ADAMS Accession No. ML082470583. 

NUREG–1575, Supplement 1, “Multi-Agency Radiation Survey and Assessment of Materials 

and Equipment Manual (MARSAME),” is a supplement to MARSSIM. MARSAME provides 

technical information on approaches for planning, implementing, assessing, and documenting 

surveys to determine proper disposition of materials and equipment. NUREG–1575, 

Supplement 1, can be found under ADAMS Accession No. ML090260577.
8-43

Survey Record Requirements

Each survey record should include the following:

• a diagram of the area surveyed 

• a list of items and equipment surveyed

• specific locations on the survey diagram where wipe test was performed

• background radiation levels with appropriate units

• contamination levels with appropriate units

• make and model number of instruments used, including calibration dates

• name of the person making the evaluation and recording the results and date

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) state, 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.

Note: 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.

Refer to Regulatory Guide (RG) 8.25, Rev. 1, “Air Sampling in the Workplace,” 

(ADAMS Accession No. ML003739616) for further guidance on air sampling.

Airborne Effluent Release Monitoring

Applicants must use procedures and engineering controls to achieve occupational doses and 

doses to members of the public that are ALARA. To implement ALARA in accordance with 

10 CFR 20.1101(d), the applicant must establish a constraint on air emissions of radioactive 

material, excluding Radon-222 and its daughters, such that the individual member of the public 

likely to receive the highest dose will not be expected to receive a total effective dose 

equivalent in excess of 10 millirem per year [0.1 millisievert per year] from these emissions. If 

this dose constraint is exceeded, the applicant must report the exceedance in accordance with 

10 CFR 20.2203, “Reports of exposures, radiation levels, and concentrations of radioactive 
8-44

material exceeding the constraints or limits,” and promptly take appropriate corrective action to 

ensure against recurrence. 

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.

RG 4.20, Revision 1, “Constraint on Releases of Airborne Radioactive Materials to the 

Environment for Licensees Other Than Power Reactors,” provides guidance on methods 

acceptable (calculation or COMPLY code) to the NRC for compliance with the constraint on air 

emissions to the environment.

RG 8.37, “ALARA Levels for Effluents from Materials Facilities,” provides guidance on 

designing an acceptable program for establishing and maintaining ALARA levels for gaseous 

and liquid effluents at materials facilities.

For release points for which monitoring is not practicable, the licensee should estimate the 

magnitude of the unmonitored effluents. These unmonitored releases will occur anytime 

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 or 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 in column 1 of 

Table 2 in 10 CFR Part 20, Appendix B, whichever is greater.

Effluent monitoring systems should be designed in accordance with International Organization 

for Standardization (ISO) 2889:2010, “Sampling Airborne Radioactive Materials 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”.

ISO 2889:2010 sets forth performance-based criteria and recommendations for the design and 

use of systems for sampling of airborne radioactive materials in the effluent air from the ducts 

and stacks of nuclear facilities.

ANSI N42.18-2004 provides recommendations for the selection of instrumentation specific to 

the continuous monitoring and quantification of radioactivity in effluents released to the 

environment. The effluent streams considered may contain radioactive gases, liquids, 

particulates, or dissolved solids singly or in combination. This standard specifies detection 

capabilities, physical and operating limits, reliability, and calibration requirements and sets forth 

minimum performance requirements for effluent monitoring instrumentation.

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 20.1301, “Dose limits for individual members of the public,” and 10 CFR 20.2003, 

“Disposal by release into sanitary sewerage,” respectively.
8-45

The topic of sanitary sewerage releases is more fully discussed in Appendix M of this NUREG.

Response from Applicant: 

Choose one of the following:

• Provide a statement that: “We will conduct surveys and maintain contamination 

levels in accordance with the survey frequencies and contamination levels 

published in Section 8.10.4 of NUREG–1556, Volume 18, Revision 1, “Consolidated 

Guidance About Materials Licenses: Program-Specific Guidance About Service 

Provider Licenses.”

OR

• Submit description of alternative survey method and frequency for demonstrating how 

to evaluate a radiological hazard.

Note: Alternative responses will be reviewed using the guidance in this section.

References:

• Regulatory Guide 8.20, Revision 2, “Applications of Bioassay for Radioiodine,” 

September 2014 (ADAMS Accession No. ML14064A060); 

• Regulatory Guide 8.21, Revision 1, “Health Physics Surveys for Byproduct Material 

at NRC-Licensed Processing and Manufacturing Plants,” October 1979

(reviewed October 2012); (ADAMS Accession No. ML003739577)

• Regulatory Guide 8.32, “Criteria for Establishing a Tritium Bioassay Program” dated

July 1988 (reviewed October 2011). (ADAMS Accession No. ML003739479)

• Federal Register (76 FR 35564) dated July 17, 2011, a final rule amending Subpart E, 

“Radiological Criteria for License Termination,” and Subpart F, “Surveys and 

Monitoring,” Title 10 of the Code of Federal Regulations (10 CFR) Part 20, “Standards 

for Protection against Radiation.”

Leak Tests

Regulations: 10 CFR 30.53, 10 CFR 35.67, 10 CFR 35.2067(a), 10 CFR 39.35, 

10 CFR 40.63, CFR 70.56

Criteria: The NRC requires testing of sealed sources containing greater than 3.7 MBq 

[100 microcuries] of beta/gamma or 0.37 MBq [10 microcuries] of alpha radioactive material, in 

order to determine whether there is any radioactive leakage from sealed sources. 

Requirements for leak tests are based on the type of radiation escaping from the inner capsule. 

Records of test results must be maintained in accordance with license conditions or, if 

applicable, NRC regulations.

Discussion: Sealed sources and devices that are approved by NRC or an Agreement State 

and used according to the respective SSD registration certificate usually pose little risk of 

contamination. Leak tests performed at the frequency specified in the SSD registration 
8-46

certificate should identify leaking sources. Leaking sources must be withdrawn immediately 

from use and decontaminated, repaired, or disposed in accordance with the disposal 

requirements in Subpart K of 10 CFR Part 20. NRC licenses will require the performance of 

leak tests on sealed sources at intervals approved by NRC or an Agreement State and 

specified in the SSD Registration Sheet. The measurement of the leak-test sample is a 

quantitative analysis requiring that instrumentation used to analyze the sample be capable of 

detecting 185 Becquerel [0.005 microcuries] of radioactivity.

Manufacturers, distributors, consultants, and other organizations may be authorized by the 

NRC or an Agreement State to either perform the entire leak test sequence on behalf of 

licensees or provide leak test kits to licensees. In the latter case, the licensee takes the leak 

test sample according to the manufacturer’s or the kit supplier’s instructions and returns it 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 licensees to conduct the entire leak test sequence themselves. A model leak test 

procedure can be found in Appendix G of this NUREG.

If the applicant will be providing leak tests as a service to others, the applicant may wish to 

distribute commercial leak test kits.

Leak test kits should contain the following:

• swabs, wipes, absorbent-tipped sticks that are to be used to make the wipes on the 

specified sources or devices

• envelopes and vials, where wipe sample will be placed after sample has been taken

• step-by-step instructions for safe use of the particular kit (these instructions will be 

specific to the types of devices/sealed sources for which the kit is designed)

• procedures for returning the wipes for analysis

• label for the customer to fill out that identifies

— customer’s name

— license number

— source or device (by manufacturer, model number, nuclide and activity) wiped

— the name of the individual who made the wipes

Response from Applicant: 

Provide one of the following: 

• A statement that: “Leak tests sample collection and analysis will be performed by an 

organization authorized by NRC or an Agreement State to provide leak testing services 

to other licensees. Leak tests may be collected by the licensee using a leak test kit 

supplier’s instructions. Such leak test kits will be supplied by an organization 

authorized by the NRC or an Agreement State to provide leak testing services.”
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OR

• A statement that: “Leak testing and analysis will be done by the applicant.” Provide the 

information in Appendix G of this NUREG supporting a request to perform leak testing 

and sample analysis and either (1) state that the applicant will follow the model 

procedures in Appendix G of NUREG–1556, Volume 18, Revision 1 “Consolidated 

Guidance About Materials Licenses: Program-Specific Guidance About Service 

Provider Licenses,” or (2) submit alternative procedures.

Note: Requests for authorization to perform leak testing and sample analysis will be reviewed 

on a case-by-case basis and, if approved, the NRC staff will authorize these activities via a 

license condition.

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 20.2106, 10 CFR 20 Appendix B

Criteria: Each licensee must evaluate the potential exposures of all workers and monitor 

occupational exposure to radiation when required, and control the occupational dose to 

individual adults to comply with the dose limits set forth in 10 CFR 20.1201, “Occupational dose 

limits for adults.” If monitoring of occupational doses is required in accordance with 

10 CFR 20.1502, then the licensee must determine the occupational radiation dose received 

during the current year, in accordance with 10 CFR 20.2104, and maintain records of the 

monitoring, regardless of the actual dose received, in accordance with 10 CFR 20.2106.

Discussion: “Occupational Dose” is defined in 10 CFR 20.1003, “Definitions,” as “the dose 

received by an individual in the course of employment in which the individual’s assigned duties 

involve exposure to radiation or to radioactive material from licensed and unlicensed sources of 

radiation, whether in the possession of the licensee or other person. Occupational dose does 

not include doses received from background radiation, from any medical administration the 

individual has received, from exposure to individuals administered radioactive material and 

released under §35.75, from voluntary participation in medical research programs, or as a 

member of the public.”

The licensee should perform an evaluation of the dose the occupationally exposed individual is 

likely to receive prior to allowing the individual to receive the dose (prospective evaluation). 

When performing the prospective evaluation, only a dose that could be received at the facilities 

of the applicant or licensee performing the evaluation needs to be considered. These 

estimates can be based on any combination of work location radiation monitoring, survey 

results, monitoring results of individuals in similar work situations, or other estimates to produce 

a “best estimate” of the actual dose received. This evaluation need not be made for every 

individual. Evaluations can be made for employees with similar job functions or work areas. If 

the prospective evaluation shows that an individual’s dose is not likely to exceed 10 percent of 

any applicable regulatory limit, the individual is not required to be monitored for radiation 

exposure, and there are no recordkeeping or reporting requirements for doses received by that 

individual. For individuals who have received doses at other facilities in the current year, the 

previous dose need not be considered in this prospective evaluation. 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 
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estimated, recorded, and reported. If the prospective dose evaluation shows that the individual 

is likely to exceed 10 percent of an applicable limit appropriate for the individual (i.e., adult, 

minor, declared pregnant woman), monitoring is required pursuant to 10 CFR 20.1502. See 

Appendix I of this NUREG for additional information on providing a prospective dose evaluation

for individual members of the public.

Licensees must monitor worker occupational exposures. 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 (individuals less than 18 years of age have annual occupational dose limits that 

are 10 percent of the annual dose limits specified 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):

— 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

As defined in 10 CFR 20.1003, a declared pregnant woman is a woman who has voluntarily 

informed the licensee, in writing, of her pregnancy and the estimated date of conception. The 

licensee must ensure that the dose to the embryo/fetus of a declared pregnant woman, during 

the entire pregnancy, does not exceed 5 mSv [0.5 rem]. Licensees are required to monitor 

declared pregnant women who are likely to receive during the entire pregnancy, from radiation 

sources external to the body, a deep-dose equivalent in excess of 1.0 mSv [0.1 rem]. All of 

the occupational dose limits continue to be applicable to the declared pregnant woman as long 

as the dose to the embryo/fetus is not exceeded.
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Total effective dose equivalent (TEDE) = the effective dose equivalent (for external 

exposures) + the committed effective dose equivalent (for internal exposures).

Figure 8-7. Annual Dose Limits for Adult Radiation Workers

To assess and determine external radiation dose, most licensees use either 

thermoluminescent dosimeters (TLDs) or optically stimulated luminescence dosimeters. In 

accordance with 10 CFR 20.1501(d)(1), these dosimeters must be processed and evaluated by 

a laboratory that holds current accreditation from the National Voluntary Laboratory 

Accreditation Program (NVLAP) and is approved to process and evaluate the type(s) of 

radiation being monitored. The exchange frequency for whole body and extremity dosimeters 

is generally monthly or quarterly, depending on the scope and extent of services.

Licensees using personnel dosimeters that require processing to determine the radiation dose 

to comply with the individual monitoring requirement for external doses in 10 CFR 20.1502(a), 

must use dosimeters supplied by a NVLAP-approved processor. Licensees should verify that 

the processor is NVLAP accredited and may consult with the processor for its 

recommendations for exchange frequency and proper use.

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. 

Licensees must provide individual radiation exposure data to each worker as required by

10 CFR 19.13.

Note: Personnel should be familiar with the survey instruments operation and capabilities 

before using the instrument at a jobsite.

Internal Radiation Dose:

Internal exposure monitoring is required, pursuant to 10 CFR 1502(b), for:

• 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

Dose Limits for

Adult Radiation Worker

(10 CFR 20.1201)
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• minors likely to receive in 1 year, a committed effective dose equivalent (CEDE) in 

excess of 1.0 mSv [0.1 rem]

• declared pregnant women likely to receive, during the entire pregnancy, a CEDE in 

excess of 1.0 mSv [0.1 rem]

Bioassays are required when individuals work with airborne radioactive material in the 

quantities, chemical and physical forms, and activities that make it likely that the radionuclide 

will be ingested, inhaled, or absorbed, resulting in an intake in excess of 10 percent of the ALIs 

in Table 1, Columns 1 and 2, of Appendix B to 10 CFR Part 20. 

For guidance on developing bioassay programs and determining internal occupational dose 

and summation of occupational dose, refer to Regulatory Guide 8.9, “Acceptable Concepts, 

Models, Equations, and Assumptions for a Bioassay Program,” and Regulatory Guide 8.34, 

“Monitoring Criteria and Methods to Calculate Occupational Radiation Doses.” 

Response from Applicant: 

Provide one of the following:

• A statement that “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

• A statement that “We will monitor individuals in accordance with the criteria in Section 

8.10.6, ‘Radiation Safety Program-Occupational Dose’ in NUREG–1556, Volume 18,

Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Service Provider Licenses.”

OR, IN LIEU OF THESE STATEMENTS

• Provide a description of an alternative method for demonstrating compliance with the 

referenced regulations.

References:

• The National Institute of Standards and Technology maintains the National Voluntary 

Laboratory Accreditation Program Directory of Accredited Laboratories at 

https://ts.nist.gov/standards/scopes/dosim.htm.

• Regulatory Guide 8.7, Revision 2, “Instructions for Recording and Reporting 

Occupational Radiation Dose Data,” November 2005 (ADAMS Accession No. 

ML052970092).

• Regulatory Guide 8.9, Revision 1, “Acceptable Concepts, Models, Equations and 

Assumptions for a Bioassay Program,” July 1993 (ADAMS Accession No. 

ML003739554).

• Regulatory Guide 8.20, Revision 2, “Applications of Bioassay for Radioiodine,” 

September 2014 (ADAMS Accession No. ML14064A060)
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• Regulatory Guide 8.34, “Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses,” July 1992 (ADAMS Accession No. ML090770221).

• Regulatory Guide 8.13, Revision 3, “Instruction Concerning Prenatal Radiation 

Exposure,” June 1999 (ADAMS Accession No. ML003739505).

• IN 2003-12, “Problems Involved in Monitoring Dose to the Hands Resulting from the 

Handling of Radiopharmaceuticals,” August 22, 2003 (ADAMS Accession No.

ML032320470).

• IN 2000-10, “Recent Events Resulting in Extremity Exposures Exceeding Regulatory 

Limits,” July 18, 2000 (ADAMS Accession No. ML003732340).

• IN 2000-16, “Potential Hazards due to Volatilization of Radionuclides,” October 5, 2000

(ADAMS Accession No. ML003753003).

Public Dose

Regulations: 10 CFR 20.1003, 10 CFR 20.1101, 10 CFR 20.1301, 10 CFR 20.1302,

10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2107

Criteria: Licensees must do the following to prevent or minimize dose to members of 

the public:

• 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 one 

year, and the dose in any unrestricted area will not exceed 0.02 mSv [2 mrem] in any 

one hour, from licensed operations.

• 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] in a year from those emissions.

• Control/maintain constant surveillance of licensed material when in use and not 

in storage.

• Secure stored licensed material from unauthorized access or removal.

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 from medical procedures. 

Whether the dose to an individual is an occupational dose or a public dose depends on the 

individual’s assigned duties and not on the area (restricted, controlled, or unrestricted) the 

individual is in when the dose is received.

For guidance about accepted methodologies for determining dose to members of public, 

please refer to Appendix I of this NUREG.

Members of the public include persons who work in or may occupy locations where licensed 

material is used or stored. Employees whose assigned duties do not include the use of 
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licensed material and work in the vicinity where it is used or stored are also included as 

members of the public. Public dose is controlled, in part, by ensuring that licensed material is 

secured (e.g., located in a locked area) to prevent unauthorized access or use. Sealed and 

unsealed materials are usually restricted by controlling access to the keys needed to gain 

access to storage locations, including storage bunkers. Only the RSO or authorized user 

should have access to the keys.

Public dose is also affected by the choice of storage and use locations at temporary jobsites. 

Licensed material must be located so that the resulting public dose in an unrestricted area 

(e.g., an office or the exterior surface of an outside wall) does not exceed 1 mSv [100 mrem] in 

a year or 0.02 mSv [2 mrem] in any one hour. Applicants should use the concepts of 

controlling time, distance, and shielding when choosing storage and use locations. Decreasing 

the time that an individual is exposed, increasing the distance from the radioactive material, 

and adding shielding that is appropriate for the specific type of radiation (e.g., steel, concrete, 

lead, hydrogenous materials) will reduce the radiation exposure.

Information provided on anticipated radiation levels of sealed sources and unsealed materials,

both inside their respective transport containers and outside the transport container at given 

distances, is the type of information needed to make public dose calculations. Licensees may 

assess radiation levels located in adjacent areas to radioactive material either by making 

calculations or by using a combination of direct measurements and calculations. After 

obtaining anticipated radiation levels or by making direct radiation measurements using an 

appropriate survey instrument, an applicant can use the “inverse square” law for point sources 

to evaluate the effect on the public, and use this information to determine operating and 

emergency procedures for using radioactive materials. See Appendix I of this NUREG for an 

example demonstrating that individual members of the public will not receive doses exceeding 

the allowable public limits.

Figure 8-8 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 total effective dose 

equivalent (TEDE). The TEDE can, however, be broken down into three major dose 

pathway groups:

(i) inhaled radioactive material

(ii) ingested radioactive material

(iii) external radioactive exposure

The licensee should review these major pathways and decide which are applicable to 

its operations.

If, after making an initial public dose evaluation, a licensee changes the conditions used for the 

evaluation (e.g., relocates radioactive material within a designated storage area, increases the 

amount of radioactive materials in storage, changes the frequency radioactive material is in 

use, or changes the occupancy of adjacent areas), the licensee must perform a new evaluation 

to ensure that the public dose limits are not exceeded and take corrective action, if required.

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 specific needs.
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Figure 8-8. Calculating Public Dose. Steps to calculate the annual dose to an individual

member of the public (see Appendix I of this NUREG for more information about 

occupancy factors).

Under 10 CFR 20.2107, “Records of dose to individual members of the public,” licensees must

maintain records sufficient to demonstrate compliance with the dose limits for members of the 

public until the Commission terminates the license.

During NRC inspections, licensees must be able to provide documentation demonstrating, by 

measurement, calculation, or a combination of both, that the total effective dose equivalent to 

any individual member of the public that is likely to receive the highest dose from licensed 

operations is less than 1 mSv [100 mrem] in 1 year, and any unrestricted area does not exceed 

0.02 mSv [2 mrem] in any 1 hour. See Appendix I of this NUREG for examples of methods to 

demonstrate compliance.

Response from Applicant: No response is required from the applicant in a license 

application, but compliance will be evaluated during inspection.
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Transportation

Regulations: 10 CFR Part 20, 10 CFR 30.41, 10 CFR 30.51, 10 CFR Part 37 (Subpart D),

10 CFR 40.51, 10 CFR 40.61, 10 CFR 70.42, 10 CFR 70.51, 10 CFR 71.5, 10 CFR 71.13,

10 CFR 71.14, 10 CFR 71.17, 10 CFR 71.37, 10 CFR 71.38, 10 CFR 71.47, Subpart H of 

10 CFR Part 71, 10 CFR Part 110, 49 CFR Parts 171-178

Criteria: Applicants that will be packaging and transporting licensed material 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: In 10 CFR 71.5, “Transportation of licensed material,” the NRC regulations 

require all licensees who transport radioactive materials outside the site of usage or where 

transport is on public highways to comply with DOT regulations. Licensees should consider the 

safety of all individuals who may handle or may come into contact with the transport containers 

or packages containing licensed material. The primary consideration in packaging licensed 

material should be to ensure that the package integrity is not compromised during transport, 

and that the radiation levels or removable contamination levels at the package surfaces meet 

the regulatory requirements of 10 CFR 71.47, “External radiation standards for all packages.” 

In all cases, ALARA concerns are addressed prior to, during, and after transporting any 

radioactive material.

Service provider personnel are authorized to prepare packages for shipment at customer 

facilities. The person signing the Shipper’s Certification on the shipping papers is responsible 

for proper package preparation. If licensed material is transferred from the customer to the 

service provider’s license at the customer’s facility, the service provider licensee becomes 

responsible for subsequent shipment of that material. Under 49 CFR 172.704—“Training 

requirements,” each person (shipper or carrier) involved in the transportation of radioactive 

materials must receive appropriate training for the jobs the employee performs related to 

transportation, every 3 years. These jobs include activities such as packaging radioactive 

materials, loading and securing the package on a vehicle, or preparation of paperwork for 

shipping the material.

Transporting licensed materials originating at certain facilities (e.g., irradiators) may involve 

quantities of radioactive material that require a Type B package that involves special 

requirements. In many cases, this material will be transferred to the service provider’s license 

and the service provider will then be responsible for its shipment. In these cases, the service 

provider must ensure that the applicant:

• is authorized to possess the licensed material at temporary jobsites (i.e., at the facility 

in question)

• takes possession of the licensed material that is transferred

• uses an approved Type B package authorized for the material to be transported
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• is registered with NRC as a user of the Type B package

• has an NRC-approved quality assurance (QA) plan

The general license requirements of 10 CFR 71.101, “Quality assurance requirements,” apply 

to all NRC licensees that transport, or deliver to a carrier for transport, licensed material in an 

NRC-approved transport package. For information about QA plans, see RG 7.10, Rev.3, 

“Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive 

Material.” NRC licensees using NRC-approved transport packages are responsible for 

ensuring that all of these requirements have been met and that they are using currently 

authorized packages (see list of approved packages in NUREG–0383, “Directory of Certificates 

of Compliance for Radioactive Materials Packages”).

Renewal of these certificates of compliance must be submitted in accordance with 

10 CFR 71.38, “Renewal of a certificate of compliance or quality assurance program approval.”

Note: Licensees shipping radioactive waste for disposal must prepare the shipment and its 

shipping manifest, as required by 10 CFR Part 20. Service providers that would like to use one 

transport package for multiple customers with multiple sources during one transportation trip 

should discuss this process with the appropriate NRC Region or Agreement State staff.

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. See Appendix J of this NUREG for a list of 

DOT regulations that may be applicable to service provider licensees.

Service providers who may transport licensed material by air outside of the United States may 

need to comply with the International Air Transport Association regulations (www.iata.org). 

Service providers may also need to obtain an additional license from the NRC for import and 

export of licensed material, in accordance with 10 CFR Part 110, “Export and Import of Nuclear 

Equipment and Material.” Service providers should be aware of countries that are listed as 

embargoed destinations in 10 CFR 110.28, “Embargoed destinations” and as restricted 

destinations in 10 CFR 110.29, “Restricted destinations.”

Note: Service providers must comply with import and export requirements, as specified in 10 

CFR Part 110, and obtain the necessary authorizations.

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.

Response from Applicant: No response is needed from applicants during the licensing 

phase. However, before making shipments of licensed materials in Type B packages, a 
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licensee must have registered with the 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 Materials Regulations Review” can be obtained by calling DOT’s 

Office of Hazardous Material Initiatives and Training at 202-366-2301. The current version of 

RG 7.10, Rev.3, “Establishing Quality Assurance Programs for Packaging Used in Transport 

of Radioactive Material,” (ADAMS Accession No. ML14064A505).

Maintenance

Regulations: 10 CFR 20.1101, 10 CFR 21

Criteria: Service providers who perform maintenance as a commercial service to other 

licensees must maintain devices (e.g., survey instrument calibrators and self-shielded 

irradiators) according to the manufacturer’s written recommendations and instructions and SSD 

registry, if applicable.

“Routine maintenance” of the device includes, but is not limited to, cleaning; lubrication; and 

changing batteries, relays, or fuses. “Nonroutine maintenance” is the repair, removal, 

replacement, or alteration involving activities during which personnel could receive radiation 

doses exceeding NRC limits. These activities could include maintenance on electrical and 

mechanical systems that directly control source or shielding movement, the device’s shielding 

or sealed source (e.g., removal), safety interlocks, any component that may affect safe 

operation of the device, or any other nonroutine maintenance that must be performed by the 

device manufacturer (or distributor) or a person specifically licensed by the NRC or an 

Agreement State.

Note: Only a person specifically licensed by the NRC or an agreement state (see comment 

below) shall install, maintain, adjust, or repair a device that involves work on the sealed 

source(s) shielding, the source(s) driving unit, or other electrical or mechanical component that 

could expose the source, reduce the shielding around the source(s), or compromise the 

radiation safety of the device or the source(s).

Discussion: Before any maintenance or repair work is performed on licensed devices, the 

service provider licensee should ensure that:

• The service to be performed is authorized on the service provider’s license.

• The manufacturer’s and distributor’s procedures will be used and followed; otherwise,

provide an equivalent procedure that will be used to perform this particular service 

activity.

• Radiation safety procedures, including the possible need for compensatory measures, 

are considered.

• ALARA considerations are factored into the activity(ies).

• Only trained and qualified individuals will perform the activity.

• Only approved parts and components will be used.
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• All necessary specialized equipment will be available to perform these activities.

• The device will be tested for full operation before it is returned to routine use.

The license will require that nonroutine maintenance be performed by the manufacturer 

(or distributor) or other persons specifically licensed by the NRC or an Agreement State to 

perform such services. Applicants seeking authorization to perform nonroutine maintenance 

should develop and submit specific procedures for review, if they do not have access to the 

manufacturer’s or distributor’s procedures. See Appendix K of this NUREG for 

more information.

Use of replacement parts (nonsafety related):

If an identical original equipment manufacturer (OEM) replacement part cannot be obtained 

and the maintenance activity does NOT involve work:

• on the sealed source(s) shielding

• on the source(s) driving unit

• on other electrical or mechanical component that could expose the source, or

• that would reduce the shielding around the source(s)

• that could compromise the radiation safety of the device or the source(s)

The service provider may substitute a non-OEM part, provided that it has the same form, fit,

and function, and this new part does not invalidate the SSD registration certificate.

EXAMPLE: Replacement Parts NOT critical to safe operations.

A light bulb on the device is not working. The service provider should replace the bulb but 

does not obtain an OEM bulb. Instead, the service provider obtains a bulb from a local vendor 

retail store. The bulb is the same wattage and similar in size. The bulb can fit into the socket.

When installed, the bulb is operational. The service provider ensures that the bulb met the 

form, fit and function test. If the bulb was needed to illuminate red as an indicator warning light 

on the device, the service provider should make sure that the bulb met that function, because

the instruction user manual may have pictures or diagrams indicating what to do if a red light is 

illuminated. Again, the service provider should perform a form, fit, and function test to ensure

that the device functioned accordingly.

Use of replacement parts (safety related):

If an identical OEM replacement part cannot be obtained and the maintenance does

involve work:

• on the sealed source(s) shielding

• on the source(s) driving unit

• on other electrical or mechanical component that could expose the source, or

• that would reduce the shielding around the source(s)

• that could compromise the radiation safety of the device or the source(s)

The service provider may obtain a part from another vendor or fabricate the part. The service 

provider should verify that the replacement part will have the commensurate form, fit, and 

function as the original component and provide this technical information to its customer. The 
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service provider should instruct its customer to provide the technical information to the NRC or 

Agreement State for a safety review of the information submitted by the customer, before 

maintenance activities occur. The service provider must have its customer obtain NRC or 

Agreement State approval, in accordance with 10 CFR 32.210, to ensure compliance with 

radiation safety measures of the original equipment BEFORE beginning this service activity.

The NRC approval for the use of non-OEM parts that could affect the safety of the device may 

be granted through one of two pathways. The service provider’s customer may request either

(1) a custom SSD registration in accordance with 10 CFR 30.32(g)(1) and 10 CFR 32.210, or 

(2) an amendment to the license in accordance with 10 CFR 30.32(g)(2).

The custom registration process involves a submission, by the customer, of information similar 

to that submitted for a new device registration, a full safety evaluation by the SSD registration 

staff, and the payment of an application fee and annual fees by the customer. The safety 

review for the license amendment is limited in scope, depending on the replacement parts 

involved, and is conducted by the technical staff, based on the existing SSD registration 

certificate. In either case, the service provider will need to assist its customer with the 

submission by providing details (e.g., description of the part(s), drawings, technical 

specifications, and the form, fit, and function).

EXAMPLE: Replacement Parts CRITICAL to safe operation

A service provider is replacing a manually operated self-shielded irradiator with a pneumatic 

tower assembly. The tower was fabricated by another service provider (here referred to as the 

subcontractor). The subcontractor fabricates and sells a pneumatic tower to the service 

provider. The service provider should ensure that the subcontractor also provides essential 

technical specifications, drawings, and other relevant information to the service provider. All of 

the technical information, including a form, fit, and function assessment, should be provided to 

the customer by the service provider. The service provider should instruct the customer to 

send this information to the regulator for a safety review. Once the safety review is complete 

and the customer receives authorization to change the tower from manual to pneumatic 

operation, the service provider may proceed with the replacement.

Equipment defects that could create a substantial safety hazard or equipment failures involving 

NRC-regulated activities must be reported to the NRC in accordance with 10 CFR 21.21 and 

10 CFR 30.50. For example, a safety interlock failure for an irradiator/calibrator and a failure of 

a source retraction mechanism in a high-dose rate (HDR) afterloader are defects that must be 

reported to the NRC. IN 91-39, “Compliance with 10 CFR Part 21, Reporting of Defects and 

Noncompliance,” dated June 17, 1991, provides additional guidance on determining whether a 

safety hazard exists and sample procedures for identifying and reporting defects. The 

Information Notice can be found on the NRC’s Generic Communications Web page under 

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

Response from Applicant:

For performance of routine maintenance, applicants submit either of the following:

• A statement that “We will implement and maintain procedures for conducting routine 

maintenance of devices according to each manufacturer’s (or distributor’s) written 

recommendations and instructions.”
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OR

• Alternative routine maintenance procedures for the NRC’s review.

For performance of nonroutine maintenance, submit the following:

• Before service begins, obtain NRC approval if OEM replacement parts cannot be used 

for sealed source shielding, the source driving unit, or other electrical or mechanical 

component that could expose the source, reduce the shielding around the source, or 

compromise the radiation safety of the device or the source.

AND

• A statement that “We will have the device manufacturer (or distributor) or other person 

authorized by NRC or an Agreement State perform nonroutine maintenance.”

OR

• Provide alternative procedures for the NRC’s review addressing the information listed in 

Appendix K of NUREG–1556, Volume 18, Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About Service Provider Licenses.”

Note: Alternative procedures submitted by the applicant for performing routine maintenance 

will be reviewed using the criteria in Appendix K of this NUREG. Information requested in 

Appendix K will be reviewed on a case-by-case basis. If approved, the license will contain a 

specific condition authorizing the licensee to perform nonroutine maintenance.

References: IN 91-39, “Compliance with 10 CFR Part 21, Reporting of defects and 

noncompliance,” dated June 17, 1991, can be found on the NRC’s Generic Communications 

Web page under Information Notices at https://www.nrc.gov/reading-rm/doc-collections/gencomm/ RIS 2013-01 “Use of Aftermarket Sealed Sources Registered under 10 CFR 32.210,” 

issued March 12, 2013 (ADAMS Accession No. ML12313A147)

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 protection 

programs at least annually to ensure that the program:

• is commensurate with the scope and extent of licensed activities

• is compliant with NRC and DOT regulations (as applicable) 

• is compliant with the terms and conditions of the license

• maintains occupational doses and doses to members of the public ALARA

• is documented and that appropriate records are maintained for the required duration

Licensees that are subject to the requirements in 10 CFR Part 37 must annually review their 

access authorization program and security program.
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Discussion: Appendix L of this NUREG contains a suggested annual audit checklist that is 

acceptable to the NRC and is specific to Service Provider licensees who perform activities 

within the scope of this NUREG. Because all areas indicated in Appendix L 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. For example, licensees do 

not need to address activities that have not occurred since the last audit.

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

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

the licensees’ audit program, licensees should consider including unannounced audits to 

determine if, for example, Operating and Emergency Procedures are available and 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,” 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/doccollections/enforcement/.

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

implementation for 3 years after the record is made, in accordance with 10 CFR 20.2102. The 

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

• date of audit 

• name of person or persons who conducted the audit

• names of persons contacted by the auditor or auditors 

• areas audited 

• audit findings and corrective actions 

• follow-up
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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: No response required. The licensee’s program for auditing its 

radiation safety program may be reviewed during inspection.

References: 

• Inspection Procedure 87126, “Industrial/Academic/Research Programs,” 

September 2005 (ADAMS Accession No. ML052730315)

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

Corrective Action,” dated May 1, 1996, (ADAMS Accession ML031060071)

• Enforcement guidance and policy, available online at https://www.nrc.gov/readingrm/doc-collections/enforcement/

Security Program for Category 1 and Category 2 Materials

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. 
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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. 

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. 
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Reference: 

Regulatory Issue Summary (RIS) 2017-02, “Applicability of Title 10 of the Code of Federal 

Regulations Part 37 to Non-Manufacturing and Distribution Service Provider Licensees,” dated 

February 2017. 

Item 11: Waste Management 

Regulations: 10 CFR 20.1301, 10 CFR 20.1501, 10 CFR 20.1904, 10 CFR 20.2001,

10 CFR 20.2002, 10 CFR 20.2003, 10 CFR 20.2004, 10 CFR 20.2005, 10 CFR 20.2006,

10 CFR 20.2007, 10 CFR 20.2008, 10 CFR 20.2108, 10 CFR Part 20, Appendices B and G,

10 CFR 30.51, 10 CFR 40.61, 10 CFR 61, 10 CFR 70.51

Criteria: Radioactive waste must be managed and disposed of in accordance with 

regulatory requirements and license conditions. Appropriate records of waste disposal must 

be maintained.

Discussion: This section applies to service providers who generate radioactive waste as a 

result of services operations or provide waste management services to customers. Waste 

management service may include, but is not limited to, commercial incineration; compaction;

solidification/vitrification; and packaging, repackaging, and transportation of radioactive waste. 

Service providers who perform these activities as a service to other licensees should also refer 

to Section 8.10.1, “Operating and Emergency Procedures” of this NUREG.

Radioactive waste generated or handled when conducting licensed activities may include 

contaminated samples, sealed sources, and unusable items contaminated with radioactive 

material (e.g., absorbent paper, gloves, filters, tools). The applicant may also be called upon to 

package radioactive waste at customer facilities for disposal. For different types of radioactive 

waste, consult with radioactive waste brokers to ensure that any waste that was generated will 

be accepted at a low-level waste disposal facility.

Service providers may not receive radioactive waste from other licensees for processing, 

storage, or disposal, unless specifically authorized to do so by the NRC. If customers wish to 

dispose of radioactive waste, including sealed sources, service provider licensees may assist 

them only by transferring licensed material to any person authorized to possess these 

materials. Individuals authorized to possess materials include:

• the original manufacturer

• the distributor

• commercial firms licensed by the NRC or an Agreement State to accept radioactive 

waste from other persons, or another specific licensee authorized to possess the 

licensed material

All radioactive waste must be stored in appropriately labeled containers until it is disposed. 

During the period between storage and disposal, container integrity must be assured. All 

radioactive waste must be secured against access or removal by unauthorized personnel. 

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 waste 

to decay-in-storage (DIS). Waste compaction or other treatments can reduce the volume of 
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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 10 CFR 20.2001-20.2007, all licensees must dispose of radioactive waste

through one of the following methods:

• decay-in-storage

• release into sanitary sewerage

• release in effluents to unrestricted areas, other than into sanitary sewerage

• transfer to an authorized recipient

• disposal of waste as if it were not radioactive (specific wastes)

• extended interim storage

• obtaining prior approval from the NRC of an alternate method

With service provider licensees, the NRC’s experience is that most dispose of radioactive 

waste by transfer to an authorized recipient(s). Applicants requesting authorization to dispose 

of radioactive waste by incineration should refer to Policy and Guidance Directive PG 8-10,

“Disposal of Incineration Ash as Ordinary Waste,” dated January 1997.

Note: Compliance with NRC regulations does not relieve a licensee of the responsibility of 

complying with any other applicable Federal, State, or local regulations. Furthermore, some 

radioactive waste called “mixed waste” may include additional hazards (e.g., biohazard or 

chemical hazard). The storage and disposal of “mixed waste” must also comply with all other 

applicable Federal, State, and local regulatory requirements.

Applicants should describe their radioactive waste management program. This program 

should include procedures for handling and storing, characterization and minimization, and 

disposal of radioactive waste. Appropriate training should be provided to waste handlers. In 

accordance with 10 CFR 20.2108, licensees must maintain all appropriate records of 

radioactive waste disposal. The U.S. Environmental Protection Agency issued guidance for 

development of a comprehensive program to reduce hazardous waste, including 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 1994.

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 decay-in-storage (DIS). The holding time of the waste should be based on the 

radionuclide(s), 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 the most sensitive scale in a low background 

area and without any interposed shielding. 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, 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.
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Procedures for management of waste being held for DIS should include methods of 

segregation according to half-life, surveys prior to 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 M of this 

NUREG provides a model procedure for disposal of radioactive waste by DIS that incorporates 

the above guidelines.

Release into Sanitary Sewerage

Regulations in 10 CFR 20.2003, “Disposal by release into sanitary sewerage,” authorize 

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 easily dispersible biological material) in water.

• Quantity of licensed material or other radioactive material that the licensee releases into 

the sewer each month divided by the average monthly volume of water released into 

the sewer does not exceed the concentration specified in 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 radioisotope to the corresponding limit in 10 CFR Part 20, Appendix B, 

Table 3, cannot exceed unity.

• Total quantity of licensed and other radioactive material released into the sanitary 

sewerage system in a year does not exceed 185 gigabecquerel (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 indeed 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 1994, provides acceptable criteria for evaluating solubility of liquid waste. Liquid 

scintillation media and ash are examples of material that may or may not be “readily 

dispersible.” Careful consideration should be given to the possibility of re-concentration of 

radionuclides that are released into the sewer. The NRC alerted licensees to the potentially 

significant problem of re-concentration 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 1984.

The regulations in 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 subject to 10 CFR 20.1301, “Dose limits for 

individual members of the public.” However, if licensed material is released to a private 

sewage treatment system, septic system, or leach field, the sludge or other solids from these 

systems may become contaminated with radioactive material. Such sludge may be required to 

be disposed of as radioactive waste, using one of the methods described in this section. 

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 

monthly and annual limits specified in regulations. Licensees are required to maintain accurate 
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records of all releases of licensed material into the sanitary sewerage. A model program for 

disposal of radioactive waste via sanitary sewer is described in Appendix M of this NUREG.

Incineration

Applicants that wish to treat or dispose of licensed material by incineration must comply with 

the requirements of 10 CFR 20.2004, “Treatment or disposal by incineration.” Policy and 

Guidance Directive PG 8-10, “Disposal of Incineration Ash as Ordinary Waste,” dated 

January 1997, provides guidance on the disposal of ash.

Applicants that are considering disposal of radioactive material by incineration should review 

RG 8.37, “ALARA Levels for Effluents from Materials Facilities,” dated July 1993. RG 8.37 

deals with the application of ALARA in controlling gaseous and liquid effluents and references 

documents containing acceptable methods of effluent monitoring.

After the applicant reviews the program and confirms that the applicant has waste that requires 

specific NRC approval for incineration, a description of the procedures used to incinerate waste 

should be provided. A model program for disposal of radioactive waste by incineration is 

described in Appendix M of this NUREG.

Note: Incinerators must also be authorized by other Federal, State, and local authorities 

to operate.

Compaction

Licensees may implement procedures to reduce the volume of radioactive waste for final 

disposal in an authorized LLW disposal facility. These procedures include volume reduction by 

segregating, consolidating, compacting, or allowing certain waste to decay in storage. Waste 

compaction or other treatments can reduce the volume of radioactive waste, but such 

processes may pose additional radiological hazards (e.g., airborne radioactivity or increased 

radiation levels) to workers, members of the public, and the environment. Safety procedures to 

address these concerns should be implemented. A model program for disposal of radioactive 

waste by compaction is described in Appendix M of this NUREG.

Transfer to an Authorized Recipient

When transferring radioactive waste, it is the licensee’s responsibility to verify that the intended 

recipient is authorized to receive the radioactive waste prior to making any shipment. The 

radioactive waste must be packaged in approved containers for shipment, and each container 

must identify the radioisotopes and the amounts contained in the waste. Additionally, 

packages must comply with the requirements of the license for a particular burial site 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 10 CFR Part 20, Appendix G, “Requirements for Transfers of LowLevel Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and 

Manifests.” Each shipment manifest must include a certification by the waste generator, as 
8-67

specified in Section II of the appendix. 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, “Control and Tracking,”

of Appendix G.

Licensees should implement procedures to reduce the volume of radioactive waste for final 

disposal in an authorized LLW disposal facility. These procedures include volume reduction by 

segregating, consolidating, compacting, or allowing certain waste to decay in storage. 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.

Because of the difficulties and costs associated with disposal of sealed sources, applicants 

should preplan the disposal. Applicants may want to consider contractual arrangements with 

the source supplier as part of a purchase agreement.

Disposal of Specific Waste as if It Were Not Radioactive

In accordance with 10 CFR 20.2005, the following radioactive wastes may be disposed of as 

nonradioactive waste:

• liquid scintillation media (including vials and other items contaminated with liquid 

scintillation media) containing no more than 1.85 kBq [0.05 mCi] 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 mCi] of H-3 

or C-14 per gram averaged over the weight of the entire animal

Applicants must have procedures that will ensure that the above limits are not exceeded and 

that the disposal of animal tissue or carcasses containing licensed material is in a manner that 

will not permit their use either as food for humans or animals. Applicants must maintain 

accurate records of these disposals, in accordance with 10 CFR 20.2108.

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. Regulatory Issue Summary 2008-12, “Considerations for Extended 

Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees,” 

dated May 9, 2008, updates information provided in IN 90-09. In addition, the NRC issued 

Regulatory Issue Summary 2011-09, “Available Resources Associated with Extended Storage 
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of Low-Level Radioactive Waste,” dated August 16, 2011, which refers to other helpful 

guidance documents.

Alternate Methods

Applicants may also request alternate methods 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, in 

accordance with 10 CFR 20.2002. Additionally, the applicant must submit its analysis and 

evaluation of pertinent information on the nature of the environment, nature and location of 

other affected facilities, and operating and emergency procedures to ensure that radiation 

doses are maintained ALARA and within regulatory limits.

Note: 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, 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, and/or special nuclear material, the licensees must, in accordance with 

10 CFR 30.51(e), 10 CFR 40.61(e), and/or 10 CFR 70.51(b)(1) and (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 10 CFR 20.2103(b)(4) of the results of measurements and 

calculations used to evaluate the release of radioactive effluents to the environment

Response from Applicant:

Provide the following:

• A statement that “We will use the model waste procedures published in Appendix M of 

NUREG–1556, Volume 18, Revision 1, ‘Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About Service Provider Licenses.’”

OR

• If the applicant wishes to use only selected model procedures, provide a statement

that “We will use the model waste procedures that are published in Appendix M of 

NUREG–1556, Volume 18, Revision 1, ‘Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About Service Provider Licenses.’”

(Specify (i) DIS, (ii) disposal of liquids into sanitary sewerage, (iii) incineration, or 

(iv) compaction.)
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AND

• If the applicant wishes to compact or incinerate radioactive waste, provide the 

requested information concerning these activities in Appendix M of this NUREG.

OR

• Provide procedures for waste management by any of the methods described in 

Section 8.11, “Waste Management,” of this NUREG. Applicants should contact 

appropriate regional office of the NRC for guidance as to how to obtain approval of any 

method(s) of waste disposal other than those discussed in this section.

OR

• If needed, the applicant should request authorization for extended interim storage of 

waste. Applicants should use the references listed in Section 8.11, “Waste 

Management,” of this NUREG for guidance and submit the required information with 

the application.

Note: Alternative responses will be reviewed using the guidance in this section.

References: 

• Policy and Guidance Directive (PG) 8-10, “Disposal of Incineration Ash as Ordinary 

Waste,” dated January 1997 (ADAMS Accession Nos. ML003744979 and 

ML 003752866 and Addendum, ADAMS Accession Nos. ML003744984 and 

ML003744988).

• Information Notice (IN) 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste 

Generators on the Elements of a Waste Minimization Program,” dated March 1994.

• IN 94-07, “Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under

the Revised 10 CFR Part 20,” dated January 1994.

• 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 1984.

• IN 90-09, “Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle 

and Materials Licensees,” dated February 1990.

• Regulatory Issue Summary (RIS) 2008-12, “Considerations For Extended Interim 

Storage Of Low-Level Radioactive Waste By Fuel Cycle And Materials Licensees,”

dated May 2008.

• RIS 2011-09, “Available Resources Associated With Extended Storage Of Low-Level 

Radioactive Waste,” dated August 2011.

• RIS 2004-17, Revision 1, “Revised Decay-In-Storage Provisions For The Storage Of 

Radioactive Waste Containing Byproduct Material,” dated September 2005.
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• All Agreement State Letter SP-97-056, dated August 1997, “Technical, Solubility 

Criteria.” 

• 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 

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

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 on NRC Form 313 to the 

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

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

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

Fees.Resource@nrc.gov.

Note: Applicants who wish to perform service operations (e.g., licensees that will repackage 

radioactive wastes) that require an environmental assessment should review 10 CFR Part 51

(particularly 10 CFR 51.30, 51.60, and 51.66) for further information concerning the 

environmental information needed by NRC to prepare an environmental assessment. 

Environmental assessments are full-cost recovery items under 10 CFR Part 170. Full cost will 

be determined based on the professional staff time and appropriate staff time expended, as 

described in footnote 3 to 10 CFR 170.31.

Note: 10 CFR 51.22(c)(14)(xii) grants a categorical exclusion for the acceptance of packaged 

radioactive wastes from others for transfer to licensed land burial facilities, provided the interim 

storage period for any package does not exceed 180 days and the total possession limit for all 

packages held in interim storage at the same time does not exceed 50 Curies.

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 protection program. The

NRC will return all unsigned applications for proper signature.
8-71

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 the application references commitments, those items will be incorporated into 

the license and therefore will become binding regulatory requirements.

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 

Title 10 of the 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 a 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.

Timely Notification of Transfer of Control

Regulation: 10 CFR 30.34(b), 10 CFR 40.41, 10 CFR 70.31

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, under Title 10 of the Code of Federal Regulations (10 CFR) 30.34(b) and the Atomic 

Energy Act, licensees must obtain prior NRC written consent before transferring control of the 

license 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

• adequate financial assurance is provided for compliance with applicable NRC 

requirements, if required
9-2

• 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.

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, Rev. 1, 

“Regulatory Requirements for Transfer of Control (Change of Ownership) of Specific Materials 

Licensees,” dated May 5, 2016 (ADAMS Accession No. ML15181A223). This RIS can also be 

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

at https://www.nrc.gov/reading-rm/doc-collections/gen-comm/.
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 the 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 the 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”; and 

10 CFR 70.17, “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 to 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 40.61, 

10 CFR 70.25(g), 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 conducted for a period of 24 months

— no principal activities having been conducted for a period of 24 months 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.

• Submit a decommissioning plan, if required by 10 CFR 30.36(g), 10 CFR 40.42(g), 

and/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), and/or 10 CFR 70.38(h) and (j).

• 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).

 

1‘Principal activities’ are activities that are essential to achieving the purpose(s) for which the license was issued or 

amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to 

decontamination or decommissioning are not principal activities.
11-2

• 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/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)(3), respectively.

• Before a license is terminated, send records of disposal of licensed material made under 

10 CFR 20.2002, 10 CFR 20.2003, 10 CFR 20.2004, 10 CFR 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), and/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, and/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), and/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 activities6 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

(ADAMS Accession No. ML16008A242), which can also be found on the NRC’s Generic 

Communications Web page under “Regulatory Issue Summaries”: https://www.nrc.gov/readingrm/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 8.5.3, “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, “Multi-Agency Radiation 

Survey and Site Investigation Manual (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.

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 
11-3

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/

APPENDIX B

SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

ITEMS 5 THROUGH 11 OF NRC FORM 313

B–1

Suggested Format for Providing Information Requested in

Items 5 through 11 of NRC Form 313

Appendix B is designed to be used for all types of applicants requesting a service provider 

license. All applicants should complete Tables B–1 through B–4, as applicable.

After selecting the applicable items that need to be addressed, refer to the corresponding 

sections in the NUREG. It is necessary for applicants to provide the level of detail required for 

the individual types of service(s) requested in the application. Note that providing information 

for very limited licenses (e.g., leak-test service provider) requires less information than would be 

required for a commercial nuclear laundry or a waste management license. Applicants for 

service provider licenses requiring authorization for types and quantities of material specific for 

broad scope licenses should refer to NUREG–1556, Vol. 11, “Consolidated Guidance About 

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

service provider licenses requiring authorization for research and development should refer to 

NUREG–1556, Vol. 7, “Consolidated Guidance About Material Licenses: Program-Specific 

Guidance About Academic, Research and Development, and Other Licenses of Limited Scope

Including Electron Capture Devices and X-Ray Fluorescence Analyzers.”
B–2

Table B–1. Items 5 & 6: Unsealed Radioactive Materials To Be Possessed and

Proposed Uses

Unsealed 

Radionuclide Chemical or Physical Form

Total Activity 

Requested

Use 

Code*

 Gas  Liquid Solid  Other: Specify

Gas  Liquid Solid  Other: Specify

Gas  Liquid Solid  Other: Specify

Gas  Liquid Solid  Other: Specify

Is the applicant going to possess, or take possession from its clients of, unsealed radionuclides? 

Provide a response and explain.

 Yes  No Explain:

Table B–2. Items 5 & 6: Sealed Radioactive Materials To Be Possessed and

Proposed Uses

Radionuclide

(Sealed Source)

Device 

Manufacturer and 

Model No.

Sealed Source

Device 

Registration No.

Maximum 

Activity per 

Source

Total 

Source 

Activity

Use 

Code

Is the applicant going to possess, or take possession from its clients of, sealed radionuclides 

and/or devices? Provide a response and explain.

 Yes  No Explain:

Table B–3. Items 5 & 6: Source and Special Nuclear Materials To Be Possessed and

Proposed Uses

Source Material

Material Mass Activity Use Code*

 Depleted 

Uranium

Kilograms MBq (mCi)

 Uranium-238 Grams MBq (mCi)

 Thorium-232 Grams MBq (mCi)

 Other: Specify Grams MBq (mCi)

Special Nuclear Material

 Uranium-234 Grams MBq (mCi)

Special Nuclear Material

Material Mass Activity Use Code*

 Uranium-235 Grams MBq (mCi)

 Plutonium-238 Grams MBq (mCi)

 Plutonium-239 Grams MBq (mCi)

*Use code represents the purpose for which licensed material will be possessed or used. Use codes are 

provided below
B–3

Use Code* Low-Risk Activities:

A. analysis of Leak-Test Samples (no collection)

B. analysis of Environmental Samples (no collection)

C. sample Collection and Analysis of Leak Tests

D. sample Collection and Analysis of Environmental Samples

E. calibration of instrument/dosimeter using low-activity sources

F. service/repair of gas chromatographs, X-ray fluorescence analyzers, and/or 

similar devices

G. training/instruction to individuals on radiation safety-related topics

H. other low-risk services not identified above, where radioactive material is used for 

commercial service activities

Use Code* High-Risk Activities:

I. service and/or repair of portable nuclear gauges (including removal of source rod)

J. service and/or repair of fixed gauges

K. service and/or repair of fixed gauges mounted on a mobile object, like a truck or railcar

L. storage of radioactive material for other entities

M. use of unsealed material in tracer studies (e.g., use inside pipes in a refinery)

N. use of remote activated robotics in radioactive contaminated areas

O. calibration of survey instruments and personnel dosimetry equipment as a service 

for others.

P. installation, radiation surveys, routine and preventive maintenance, adjustment or repair 

of high-dose rate (HDR) remote afterloaders, teletherapy, or gamma stereotactic 

radiosurgery units that require access to the sealed source(s), driving units, or other 

electronic components that could expose the sealed source, reduce the shielding, or 

compromise the radiation safety of the device or safety systems

Q. installation, relocation, removal from service, disposal, radiation surveys, routine or 

preventive maintenance, adjustment, training, or repair of

(1) self-shielded irradiators [American National Standards Institute (ANSI)

Category I irradiators].

(2) Title 10 of the Code of Federal Regulations (10 CFR) Part 36 irradiators 

(ANSI Categories II, III, and IV irradiators)
B–4

R. nuclear laundry services

S. retrieval of industrial radiography sealed sources

T. decontamination and decommissioning services (NUREG–1757, Volume 1)

U. waste management services, including, packaging and repackaging of radioactive waste 

for transportation, commercial incineration, compaction, super compaction, solidification,

or vitrification

V. other high-risk services not identified above, excluding activities involving critical mass 

quantities of special nuclear material

If the applicant desires to perform tracer/field studies in which licensed material is deliberately 

released to the environment, please provide the following information:

• a complete application describing the type and amount of material to be used, the 

location of use, and training and experience of the individual using the material

• a copy of the applicant’s operating and emergency procedures

• a description of the amount of radioactive material to be released in the field, 

decontamination procedures at the conclusion of the experiment, if appropriate, and 

procedures for minimizing releases

• a description of the expected radiation dose to humans

• a sample agreement letter between the applicant and the applicant’s customer 

acknowledging the use of radioactive materials at the customer’s site.

• a letter from the appropriate state health authorities, indicating that they have reviewed 

the applicant’s application and concur with the applicant’s request
B–5

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

RADIOACTIVE MATERIAL

5.3 Recordkeeping For Decommissioning

Provide the following statement: 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 drawings and 

records important to decommissioning and will

transfer these records to an NRC or Agreement 

State licensee before licensed activities are 

transferred. 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 or to assign the 

records to the appropriate NRC regional office 

before the license is terminated.”



5.4 Financial Assurance

Financial assurance is not required for most 

service provider applicants. If the applicant is 

going to possess radioactive material but wants 

to keep the possession limits below the 

requirements for financial assurance, commit to 

the following statement:

“We shall restrict the possession of licensed 

material to quantities below the minimum limit 

specified in 10 CFR 30.35(d), 10 CFR 40.36(b),

and/or 10 CFR 70.25(d) for establishing 

decommissioning financial assurance.”

 

OR

If financial assurance is required, submit 

evidence of financial assurance following the 

guidance in NUREG–1757, Volume 3.

 
B–6

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

5.5 Emergency Plans

Low Risk Activities:

The applicant is not required to submit a 

response to emergency plans during the 

licensing process.

If an emergency plan is required as described in 

10 CFR 30.32(i), provide either:



An evaluation showing that the maximum off-site 

dose due to 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

that contains the information specified in 10 CFR 

30.32(i)(3).

 

7 Individual(s) Responsible For Radiation 

Safety Program And Their Training 

Experience

7.1 Radiation Safety Officer

Provide the name of the proposed RSO who will 

be responsible for ensuring that the licensee’s 

radiation safety program is implemented in 

accordance with approved procedures.



AND

Demonstrate that the RSO has sufficient 

independence and direct communication with 

responsible management officials by providing a 

copy of an organizational chart by position and

demonstrating day-to-day oversight of the 

radiation safety activities.

AND

Confirm that the RSO will be available for 

emergencies and can be on-site within 

24-48 hours, if applicable.



AND
B–7

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

7.1 Radiation Safety Officer

Provide the specific training and experience of 

the RSO, and include the specific dates of 

training in radiation safety.



Provide alternative information demonstrating 

that the proposed RSO is qualified by training 

and experience (e.g., Board Certification by the 

American Board of Health Physicists, completion 

of a bachelor’s and/or master’s degree in the 

sciences with at least one year of experience in 

the conduct of a radiation safety program of 

comparable size and scope).



OR

7.2 Authorized Users And Radiation Workers

Provide either of the following:

A statement that: “Before using licensed material, 

authorized users will receive the training 

described in Appendix D of NUREG–1556, 

Volume 18, Revision 1, ‘Consolidated Guidance 

About Materials Licenses: Program-Specific 

Guidance About Service Provider Licenses.’”

 

OR

A description of the training and experience for 

proposed authorized users. 

AND

A description of the radiation safety training 

involving the use of licensed material that will be 

provided as a service to customers, if training is 

provided by the service provider.



8 Training For Individuals Working In Or 

Frequenting Restricted Areas

Provide either of the following:

A statement that: “Before working in the vicinity of

licensed materials, personnel will have 

successfully completed training commensurate 

with assigned duties.”

 

OR
B–8

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

8 Training For Individuals Working In Or 

Frequenting Restricted Areas

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 

refresher training.



9 Facilities And Equipment

Low Risk Activities:

For service providers performing low-risk 

activities, no facility description is required. 

Provide the location where these services will be 

performed. 

AND

Indicate if services will be performed at 

temporary jobsites. No facility description is 

required.

High Risk Activities:

For service providers performing the high-risk 

activities that will not take possession of 

radioactive material, provide the location where 

these services will be performed. Also indicate if 

services will be performed at temporary jobsites.





OR
B–9

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description

Attached

9 Facilities And Equipment

For those services listed in the high-risk group

where permanent facilities are specifically 

identified on the license, provide the following 

information, as applicable to the service the 

applicant intends to perform:

Submit a drawing or sketch of the proposed 

permanent facility that fulfills the following 

requirements:

1. Identify area(s) assigned for the receipt, 

storage, security, preparation, handling, 

waste storage, and measurement of 

radioactive materials, including sealed 

sources and devices.



2. Show the relationship and distance between 

restricted areas and adjacent unrestricted 

areas. 



3. Indicate the scale, or include dimensions on 

each drawing or sketch. The same scale 

should be used for all sketches and 

drawings. The recommended scale is 1/4 

inch = 1 foot. Drawings to this scale that do 

not fit on 8-1/2 x 11-inch paper may be 

provided as sectional drawings. Please also

include a compass directional arrow to 

indicate “North.”



4. Specify shielding materials (e.g., concrete, 

lead) and means for securing radioactive 

materials from unauthorized removal.



5. Illustrate area(s) where explosive, 

flammable, or other hazardous materials 

may be stored;



6. Identify area(s) where radioactive materials 

may become airborne. The diagram should 

contain descriptions of the ventilation 

systems, with pertinent airflow rates, filtration 

equipment, sample collection points, and 

monitoring systems;


B–10

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

9 Facilities and Equipment

7. Identify specialized handling tools, facility 

safety interlocks designed to prevent 

operation of radiological safety systems, in 

the event that operation of a system could 

result in accidental exposure or release of 

material [e.g., high efficiency particulate air 

(HEPA) filters, ventilation system, safety 

door interlocks, etc.] or equipment;



8. Identify radioactive waste handling 

equipment that includes, for example,

incinerators, compactors, solidification 

equipment, hold-up tanks, and sample 

collection points;



In addition, describe:

1. Engineered safety systems (e.g., area 

monitors, interlocks, alarms);



2. Protective clothing (such as latex or rubber 

gloves, lab coats or coveralls, respirators, 

booties, and face shields), auxiliary 

shielding, absorbent materials, secondary 

containers for wastewater storage for 

decontamination purposes, plastic bags for 

storing such items as contaminated items, 

etc., that will be available for use when 

handling unsealed or uncontained 

radioactive materials;



3. The general location of each proposed 

permanent facility (e.g., an industrial park, 

an office complex) and its current use. If any 

proposed permanent facility is a private 

residence, provide diagrams of the 

installation that include the building, the 

proposed restricted area or areas, and 

adjacent areas, including above and below 

the restricted areas; provide commitments 

that restricted areas do not include 

residential quarters, and explain how 

radiation levels in unrestricted areas will be 

maintained at less than 1 mSv [100 mrem]

per year.


B–11

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

9 Facilities and Equipment

4. The proposed nuclear laundry facilities, if 

applicable, used for contaminated protective 

equipment and clothing. Specify how the 

contaminated waste water from the laundry 

machines or sinks is disposed. Operating 

and emergency procedures should address 

decontamination of the laundry area and 

equipment.



10 Radiation Safety Program

10.1 Operating and Emergency Procedures

Low Risk Activities:

Applicants who perform low-risk licensed 

activities are not required to submit operating 

procedures but should provide emergency 

procedures for all likely scenarios.

High Risk Activities: 

Applicants who perform high-risk licensed 

activities should submit their operating and 

emergency procedures for radiological conditions 

that might be encountered as part of their license 

application.





10.2 Material Receipt and Accountability

Provide the following statement: “We will 

develop, implement, and maintain procedures for 

ensuring accountability of licensed materials at all 

times.”



AND

Provide the following statement, if applicable: 

“We will comply with the National Source 

Tracking System (NSTS) reporting requirements,

as described in 10 CFR 20.2207.”

 

AND
B–12

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

10.2 Material Receipt and Accountability

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 5 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

A description of the procedures for ensuring that 

no sealed sources have been lost, stolen, or 

misplaced.



10.3 Radiation Monitoring Instruments

Provide one of the following:

Describe the instrumentation that will be used to 

perform the required radiological surveys and 

state that: “We will use instruments that meet the 

radiation monitoring instrument specifications 

published in Appendix F of NUREG–1556, 

Volume 18, Revision 1, ‘Consolidated Guidance 

About Materials Licenses: Program-Specific 

Guidance About Service Provider Licenses.’ We 

reserve the right to upgrade our survey 

instruments as necessary.”

  

OR

Describe the instrumentation that will be used to 

perform the required radiological surveys and 

state, “We will use instruments that meet the 

radiation monitoring instrument specifications 

published in Appendix F NUREG–1556, Volume 

18, Revision 1, ‘Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance 

About Service Provider Licenses.’ Additionally, 

we will implement the model radiation survey 

meter calibration program published in Appendix 

F of NUREG–1556, Volume 18, Revision 1, 

‘Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About 

Service Provider Licenses.’ We reserve the right 

to upgrade our survey instruments as necessary.”

  
B–13

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

OR

10.3 Radiation Monitoring Instruments

Describe alternative equipment and/or 

procedures for ensuring that appropriate 

radiation-monitoring equipment will be used 

during licensed activities, and that proper 

calibration and calibration frequency of survey 

equipment will be performed. Include a

statement that: “We reserve the right to upgrade 

our survey instruments as necessary.” 

  

10.4 Surveys

Choose one of the following:

Provide the following statement: “We will conduct 

surveys and maintain contamination levels in 

accordance with the survey frequencies and 

contamination levels published in Section 8.10.4 

of NUREG–1556, Volume 18, Revision 1,

“Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About 

Service Provider Licenses.””

 

OR

Submit a description of an alternative survey 

method and frequency for demonstrating how to 

evaluate a radiological hazard.



10.5 Leak Tests

Provide one of the following:

A statement that: “Leak tests sample collection 

and analysis will be performed by an 

organization authorized by NRC or an 

Agreement State to provide leak testing services 

to other licensees. Leak tests may be collected 

by the licensee using a leak test kit supplier’s 

instructions. Such leak test kits will be supplied 

by an organization authorized by the NRC or an 

Agreement State to provide leak tesing services.”

 

OR
B–14

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

10.5 Leak Tests

A statement that: “Leak testing and analysis will 

be done by the applicant.” Provide the 

information in Appendix G of this NUREG 

supporting a request to perform leak testing and 

sample analysis, and either (1) state that the 

applicant will follow the model procedures in 

Appendix G of NUREG–1556, Volume 18, 

Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance 

About Service Provider Licenses, or (2) submit 

alternative procedures.

  

10.6 Occupational Dose

Provide one of the following:

A statement that: “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

A statement that: “We will monitor individuals in 

accordance with the criteria in the Section 8.10.6,

‘Radiation Safety Program–Occupational Dose’ in 

NUREG–1556, Volume 18, Revision 1, 

“Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About 

Service Provider Licenses.””

 

OR, 

IN LIEU OF THESE STATEMENTS

Provide a description of an alternative method for 

demonstrating compliance with the referenced 

regulations. 


B–15

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

10.7 Public Dose

No response is required from the applicant in a 

license application, but compliance will be 

evaluated during inspection.

10.8 Transportation

No response is needed from applicants during 

the licensing phase. Transportation issues will 

be reviewed during inspection.

10.9 Routine Maintenance

Provide either of the following:

A statement that: “We will implement and 

maintain procedures for conducting routine 

maintenance of devices according to each 

manufacturer’s (or distributor’s) written 

recommendations and instructions.”

 

OR

Provide alternative routine maintenance 

procedures for NRC’s review.



10.9 Nonroutine Maintenance

Provide the following:

Obtain prior NRC approval, if OEM replacement 

parts cannot be used, for sealed source 

shielding, the source driving unit, or other 

electrical or mechanical component that could 

expose the source, reduce the shielding around 

the source, or compromise the radiation safety of 

the device or the source 

 

AND
B–16

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

10.9 Nonroutine Maintenance

A statement that: “We will have the device 

manufacturer (or distributor) or other person 

authorized by NRC or an Agreement State to 

perform nonroutine maintenance of devices.”



OR

Provide alternative procedures for the NRC’s 

review addressing the information listed in 

Appendix K of NUREG–1556, Volume 18, 

Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance 

About Service Provider Licenses.”



10.10 Audit and Review of Program

No response is needed from applicants during 

the licensing phase. The licensee’s program for 

auditing its radiation safety program may be 

reviewed during inspection.

10.11 Security Program for Risk Significant 

Radioactive Material

 

Licensees must ensure the security and control 

of licensed material.

In addition, 10 CFR Part 37 describes increased 

security measures for certain types and amounts 

of radioactive material.

No response is required from the applicant or 

licensee. Compliance with access authorization 

and security program requirements may be 

reviewed during NRC inspections.
B–17

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

11 Waste Management

Provide the following:

A statement that: “We will use the model waste 

procedures published in Appendix M of NUREG–

1556, Volume 18, Revision 1, ‘Consolidated 

Guidance About Materials Licenses: ProgramSpecific Guidance About Service Provider 

Licenses.’”

 

OR

If the applicant wishes to use only selected model 

procedures, provide a statement that: “We will 

use the model waste procedures that are 

published in Appendix M of NUREG–1556, 

Volume 18, Revision 1, ‘Consolidated Guidance 

About Materials Licenses: Program-Specific 

Guidance About Service Provider Licenses’” 

(specify below);

(1) Decay-In-Storage

(2) Disposal of Liquids Into Sanitary Sewerage 

(3) Incineration

(4) Compaction

















AND

If the applicant wishes to compact or incinerate 

radioactive waste, provide the requested 

information concerning these activities in 

Appendix M of this NUREG.



OR

Provide procedures for waste management by 

any of the methods described in Section 8.11, 

“Waste Management” of this NUREG. Applicants 

should contact the appropriate regional office of 

the NRC for guidance as to how to obtain 

approval of any method(s) of waste disposal other 

than those discussed in this section.


B–18

Table B–4. Items 5.3 through 11: Training and Experience, Facilities and Equipment,

Radiation Safety Program, and Waste Disposal (Continued)

Item 

Nos. Title and Criteria Yes No N/A

Description 

Attached

11 Waste Management

OR

If needed, the applicant should request 

authorization for extended interim storage of 

waste. Applicants should use the references at 

the end of Section 8.11, “Waste Management” of 

this NUREG for guidance and submit the required 

information with the application.

  
APPENDIX C

TYPICAL DUTIES AND RESPONSIBILITIES OF THE

RADIATION SAFETY OFFICER

C–1

Typical Duties and Responsibilities of the Radiation Safety Officer

The radiation safety officer’s (RSO’s) duties and responsibilities include ensuring radiological 

safety and compliance with the U.S. Nuclear Regulatory Commission (NRC) and 

U.S. Department of Transportation (DOT) regulations and the conditions of the license. 

Typically, these duties and responsibilities include ensuring the following:

• Activities involving licensed material that the radiation safety officer (RSO) considers 

unsafe are stopped.

• Radiation exposures are kept as low as is reasonably achievable (ALARA).

• Up-to-date operating, emergency, and security procedures are developed, implemented, 

maintained, and distributed.

• All activities involving radioactive material, including monitoring and surveys of all areas 

in which radioactive material is used are overseen.

• Safety consequences of nonroutine operations are analyzed before conducting any such 

activities that have not been previously analyzed.

• Nonroutine operations are performed by the manufacturer, distributor, or person 

specifically authorized by the U.S. Nuclear Regulatory Commission (NRC) or an 

Agreement State.

• Any incidents are investigated and any emergencies are responded to.

• Availability to serve as a point of contact for the NRC’s, Agreement State’s, and 

licensee’s management during routine operations, emergencies, or incidents.

• Proper authorities of incidents, such as damage to sealed sources/devices, loss of 

licensed material, fire, theft, etc are notified.

• Investigation of unusual occurrences, identify cause(s) and appropriate corrective 

action(s), and take timely corrective action(s) to prevent recurrence.

• Properly secure licensed radioactive materials.

• Possession, installation, relocation, use, storage, repair and maintenance of sealed 

sources, devices and radioactive wastes are consistent with the limitations in the license, 

individual Sealed Source and Device Registration Certificate(s), and the manufacturer’s 

specific recommendations and instructions.

• Prospective evaluations are performed to demonstrate that unmonitored individuals are 

not likely to receive a radiation dose in excess of the limits in 10 CFR 20.1502(a) or that 

personnel monitoring devices are provided.

• Identification of the need for personnel monitoring, distribute and collect personnel 

radiation monitoring devices, evaluate bioassays, monitor personnel radiation exposure 

and bioassay records for trends and high exposures, notify individuals and their 
C–2

supervisors of radiation exposures approaching the limits, and recommend appropriate 

remedial action. Record and maintain the results of such monitoring.

• Documentation is maintained to demonstrate, by measurement or calculation, that the 

total effective dose equivalent to the individual member of the public likely to receive the 

highest dose from the licensed operation does not exceed the annual limit in Title 10 of 

the Code of Federal Regulations (10 CFR) Part 20.1301, “Dose limits for individual 

members of the public.”

• Licensed material is transported in accordance with all applicable NRC and 

DOT requirements.

• Understanding of and maintenance of up-to-date copies of NRC regulations, the license, 

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 the NRC during the licensing process.

• Amendment and renewal requests are submitted in a timely manner.

• All areas in which radioactive material is used are monitored and surveyed.

• The inventory and leak testing of sealed sources is performed/overseen.

• The inventory and calibration of radiation survey instruments is performed/overseen. 

• Necessary information on all aspects of radiation protection to personnel at all levels of 

responsibility, pursuant to 10 CFR Part 19 and Part 20 and any other applicable 

regulations.

• 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 are overseen.

• Individuals involved with using radioactive materials are properly trained and evaluated.

• The radioactive waste disposal program, including effluent monitoring and recordkeeping on waste storage and disposal records is supervised and coordinated.

• Licensed material is disposed of properly.

• The storage of radioactive material not in current use, including waste, is overseen.

• An inventory of all radioisotopes possessed under the license and limit the quantity to 

the amounts authorized by the license is maintained.

• Decontamination and recovery activities are overseen.

• Periodic audits are performed, at least annually, of the radiation safety program to 

ensure that the licensee is complying with all applicable NRC regulations and the terms 

and conditions of the license.
C–3

• The results of audits, identification of deficiencies, and recommendations for change are 

documented (and maintained for 3 years after the record is made) and provided to 

management for review; ensure that prompt action is taken to correct deficiencies.

• The audit results and corrective actions are communicated to all personnel who use 

licensed material.

• When the licensee identifies violation(s) of regulations or license conditions or program 

weaknesses, corrective action(s) are developed, implemented, and documented.

• All incidents, accidents, and personnel exposure to radiation in excess of ALARA or

10 CFR Part 20 limits are investigated and reported to NRC and other appropriate 

authorities, if required, within the required time limits.

• Required records that are necessary to support the license and satisfy NRC or 

Agreement States regulations are maintained.

• Documents are posted as required by 10 CFR 19.11, “Posting of notices to workers,” 

(10 CFR Part 19, license documents, operating procedures, NRC Form 3, “Notice to 

Employees,”), and 10 CFR 21.6, “Posting Requirements,” (10 CFR Part 21 Section 206 

of the Energy Reorganization Act of 1974, procedures adopted under Part 21), or a 

notice is posted indicating where these documents can be examined.
C–4

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 Protection 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 D

CRITERIA FOR ACCEPTABLE TRAINING AND EXPERIENCE FOR 

AUTHORIZED USERS

D–1

Criteria for Acceptable Training and Experience for Authorized Users

Classroom Training

Classroom training may be in the form of lecture, videotape, or self-study that emphasizes 

practical subject matter important to the safe handling of licensed materials. Duration and 

technical level of training should be commensurate with the expected hazards encountered 

during routine and emergency conditions. Training records should be kept in accordance with 

Title 10 of the Code of Federal Regulations (10 CFR) 30.51(b) and be available for inspection.

Frequency of Training

Training should be completed: 

• Before assuming duties with, or in the vicinity of, radioactive materials

• Whenever there is a significant change in duties, regulations, or the terms and 

conditions of the license

• Annually for refresher training

Suggested Radiation Safety Topics

• Fundamentals of Radiation Safety:

— Characteristics of radiation

— Units of radiation dose and quantity of radioactivity

— Hazards of exposure to radiation

— Levels of radiation from licensed material

— Methods of controlling radiation dose (time, distance, and shielding)

— As low as is reasonably achievable (ALARA) concept

• Radiation Detection Instruments:

— Operation

— Calibration

— Limitations of radiation survey instruments

— Radiation survey techniques for measuring radiation field

— Radiation survey techniques for measuring removable/fixed contamination

— Handling and proper use of personnel monitoring equipment

• Radiation Protection Equipment and Use:

— Proper use of protective equipment

— Decontamination of contaminated protection equipment

• U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Parts 19 and 20)

• NRC regulations (10 CFR Parts 21, 30, 31, 32, 33, 34, 35, 36, 37, 39, 40, 61, 70, and 

71) as applicable
D–2

• Licensee’s operating and emergency procedures

• Case histories relevant to operations

• Course Examination (Didactic):

— Successful completion of closed-book written/oral examination depending on the 

complexity and hazards of authorized activities

— Review of incorrect answers with student

• On-the Job Training and Examination (Practical):

— On-the-job training completed under the supervision of a qualified individual 

[authorized user (AU), radiation safety officer (RSO), or manufacturer’s 

representative authorized by the NRC or an Agreement State] that includes 

supervised hands-on experience performing the task authorized on the license 

that is commensurate with the expected hazards during routine and 

emergency conditions

— Practical examination consisting of an assessment by the RSO to ensure that 

each proposed AU is qualified to work independently and that each individual is 

knowledgeable of the radiation safety aspects of licensed activities. This may be 

demonstrated by observing the proposed AU perform licensed activities.

• Discussion and/or drill on all applicable emergency procedures annually.

• Retraining on areas found to be deficient in both the practical and didactic areas.

Classroom Course Instructor Qualifications

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

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

Instructors who provide classroom training to individuals in the principles of radiation and 

radiation safety should have knowledge and understanding of these principles beyond those 

obtainable in a course similar to the one given to prospective authorized users. Individuals who 

provide instruction in the hands-on use of licensed materials should have training and 

experience that would qualify them to be authorized users, or should possess a thorough 

understanding of the licensee operations.
APPENDIX E

MATERIAL ORDERING AND PACKAGE RECEIPT AND OPENING

E–1

Material Ordering and Package Receipt and Opening

The radiation safety officer (RSO) will approve or place all orders for radioactive material and 

will ensure that the requested material, quantities, manufacturer, and model are authorized by 

the license and that the possession limits are not exceeded. The RSO should be aware of how 

much licensed material is actually possessed, as opposed to the licensed possession limits. 

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 Model 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, manufacturer, and model 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 Radiation Safety Office (or designated receiving area). 

• If radioactive material will be held at an alternate location (for example, a carrier’s 

holding facility) or shipped directly to the service provider’s customer’s location, the RSO 

will ensure that the package is received properly.

• 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:

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 (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: 

Business Cell Phone: 
E–2

Sample Instructions to Personnel Involved in Material Receipt

For additional information on worker training, see Section 8.8, “Training for Individuals 

Working In or Frequenting Restricted Areas.”

Materials Possessed Under a General License or Received from a General Licensee

Individuals at a licensee’s facility may receive and use material pursuant to a general license as 

authorized in 10 CFR Part 31, 40 and 70. Generally licensed materials are distributed by 

manufacturers authorized by the U.S. Nuclear Regulatory Commission (NRC) to distribute 

materials directly to the persons who will use them under a general license. Some common 

items include nickel-63 sources in electron capture detectors in certain gas chromatographs, 

tritium gas contained in self-luminous exit signs, calibration sources in liquid scintillation 

counters, and uranyl acetate used for staining electron microscope samples. The licensee

should develop a policy for how their institution will require responsible use and tracking of 

this material.

If the licensee possesses generally licensed materials and wishes to transfer them to a specific 

license, they should review the regulations in 10 CFR Parts 30, 31, 40, or 70, as applicable, to 

determine how this may be done.

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:

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 the package remain until the RSO responds to monitor the 

package to determine if additional surveys are required of the vehicle or personnel. 

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 
E–3

• 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 8-3, “Package Monitoring Requirements,” Section 8.10.2 of this NUREG.

• Check U.S. Department of Transportation (DOT) White I, Yellow II, or Yellow III label or 

packing slip for activity of contents, to ensure that the shipment 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., 

inspect 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 at 301-816-5100, by 

telephone, 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, “External 

radiation standards for all packages.”

Sample Transfer Policy Statement

Internal Transfers

Licensed materials that may be transferred from one department or laboratory or authorized 

user’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 done 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 and shipments must be packaged and labeled in 

accordance with DOT, NRC, or U.S. Postal Service Regulations, whichever is applicable. If 

licensed material is possessed at a customer’s facility incident to performing services, this 

material will not be transferred to the service provider unless the service provider will be 

preparing it to be shipped AND will be the shipper of record (i.e., signing the Shipper’s 

Certification on the shipping paper.) Prior to any transfer from the license, the licensee must 
E–4

verify that the recipient is authorized to receive the licensed material, as required by 

10 CFR 30.41, 40.51 and 70.42.

Donations

On occasion, licensees may be offered or have donated licensed materials by other individuals 

(e.g., a retiring medical practitioner donating his cesium 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 and package receipt and 

accountability procedures should be followed and documented as for all licensed material. The 

donation should be managed as an internal or external transfer, as appropriate.
APPENDIX F

RADIATION MONITORING INSTRUMENT SPECIFICATIONS 

AND MODEL RADIATION SURVEY INSTRUMENT AND

AIR SAMPLER CALIBRATION PROGRAM

F–1

Radiation Monitoring Instrument Specifications and Model Radiation 

Survey Instrument and Air Sampler Calibration Program

The specifications in Table F–11 will help applicants and licensees choose the proper radiationdetection equipment for monitoring the radiological conditions at their facilities or jobsites. 

Additional information about instruments and their uses also can be found in NUREG–1575, 

“Multi Agency Radiation Survey and Sited Investigation Manual (MARSSIM),” Chapter 6 and 

Appendix H.

Table F–1. Typical Survey Instruments2

Portable Instruments Used for Contamination and Ambient Radiation Surveys

Detectors Radiation Energy Range Efficiency

Exposure Rate Meters Gamma, XRaymicro-Roentgen to Roentgen N/A

Count Rate Meters

Geiger Mueller (GM) Alpha All energies 

(dependent on window thickness)

Moderate

Beta All energies 

(dependent on window thickness)

Moderate

Gamma All energies < 1 percent

Sodium Iodide (NaI)

Scintillator

Gamma All energies 

(dependent on crystal thickness)

Moderate

Plastic Scintillator Beta C-14 or higher 

(dependent on window thickness)

Moderate

BF3 Proportional 

Tube*

Neutron Thermal Neutron High

Stationary Instruments Used to Measure Wipe, Bioassay, and Effluent Samples

Detectors Radiation Energy Range Efficiency

Liquid Scintillation 

Counter*

Alpha All energies High

Beta All energies High

Gamma Moderate

Gamma Counter (NaI)* Gamma All energies High

 

1Table from “The Health Physics and Radiological Health Handbook, Revised Edition,” edited by Thomas E. Johnson 

and Brian K. Birky, 2012 (except for * items).

2Instruments used to measure radiological conditions at licensed facilities or jobsites.
F–2

Table F–1. Typical Survey Instruments2

Gas Proportional Alpha All energies High

Beta All energies Moderate

Stationary Instruments Used to Measure Wipe, Bioassay, and Effluent Samples

Detectors Radiation Energy Range Efficiency

Gamma All energies < 1 percent

In addition to selecting an instrument that is appropriate for the radiation(s) of interest, it is 

important to know if the instrument is sufficiently sensitive to make measurements at the 

required level. This is particularly important for measurements such as leak-test samples and 

bioassay measurement, and for decommissioning of facilities or equipment. The “minimum 

detectable activity” (MDA) for the applicant’s instrument should be a fraction (10 to 50 percent) 

of the criteria the applicant must meet. 

Example 1: A sealed source is considered to be leaking if a removable contamination exceeds 

185 becquerels [0.005 microcurie, or 11,100 disintegrations per minute (dpm)]. The instrument 

used to measure wipe-test samples should have an MDA of 10 percent of that limit, or 

1,100 dpm for the radionuclide being tested; this is usually easy for cobalt-60 or cesium-137, but 

more difficult to detect for nickel-63, depending on the instrument used to analyze the sample.

Example 2: The licensee is closing a laboratory where uranyl acetate (generally licensed 

pursuant to Title 10 of the Code of Federal Regulations (10 CFR) 40.22, “Small quantities of 

source material”) was used. The total residual contamination screening value for uranium-238 

is 101 dpm/100 cm2

. The MDA for direct measurements of uranium-238 should be made at 

10 to 50 percent of the screening value for uranium-238, or 10 to 50 dpm/100 cm2

.

When the sample count time and the background count time are the same, a simplified 

calculation can be used to determine the MDA for a static measurement. This simplified 

calculation assumes that the type I error (false positive) and Type II error (false negative) are 

both selected to be equal in probability and at the 95 percent confidence error. 

Note 1: This calculation can be modified for more complex situations, as described in

NUREG–1575, Chapter 6, “Field Measurements Methods and Instrumentation.”

Note 2: This equation applies only to instruments used in scalar mode, accumulating counts of 

radiation detected over a defined period of time. It is NOT applicable to survey instruments 

used in rate meter mode.
F–3

This simplified equation is:

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 and sample counting time in minutes (min)

E = detector efficiency in counts per disintegration (c/d)

Example:

A gas-flow proportional counter is used in scalar mode to make 1-minute counts of samples.

background count rate (bkg) = 300 cpm

sample counting time (t) = 1 min

background counting time (t) = 1 min

efficiency (E) = 0.15 c/d

MDA = 

2.71 + 4.65 �bkg × t

t × E = 

2.71 + 4.65 �300 cpm × 1 min

1 min × 0.15 (c/d) = 555 dpm

According to this calculation, the licensee would be confident that 95 percent of the time, the 

instrument can reliably detect measurements as low as 555 dpm. This is the minimum activity 

that the instrument can detect; results below this number are not reliable at the 95 percent 

confidence interval. However, all numerical results should be recorded. From the basic MDA, 

the licensee can determine the minimum detectable concentration (MDC) for the actual 

measurement conditions. 

For example, suppose the above measurement was made with a radiation survey meter 

probe with a surface area of 15 square centimeters (cm2

); then the MDC would be calculated 

as follows:

MDC = 555 dpm/15 cm2 = 37 dpm/cm2 or 3700 dpm/100 cm2

Determining the MDA or MDC for instruments used in rate meter mode and for scanning 

surveys is more complicated. If the licensee will be performing surveys for decommissioning, 

which require direct measurement surveys, scanning measurement surveys, and surveys for 

removable contamination, review NUREG–1757, “Consolidated Decommissioning Guidance.” 

Additional information related to determining the MDA and MDC for direct measurements and 

scanning measurements may be found in Chapter 6 and Appendix H of NUREG–1575.

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:
F–4

— 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 survey instrument 

calibration

— conducting radiation survey meter calibrations under the supervision and in the 

physical presence of an individual authorized to perform calibrations

Facilities and Equipment for Calibration of Dose and Dose Rate Measuring Instruments

• Individuals conducting radiation survey instrument calibrations will wear 

assigned dosimetry.

• Individuals conducting calibrations will use a calibrated and operable radiation 

survey instrument to ensure that unexpected changes in exposure rates are identified 

and corrected.

• 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. Posting as a radiation area also may be 

required by Subpart J of 10 CFR Part 20.

• Depending on the type of calibrator or irradiator source used for calibration, the device 

and facilities may fall under the regulations on 10 CFR Part 36, “Licenses and Radiation 

Safety Requirements for Irradiators,” and require interlocks and alarms. Review 

NUREG–1556, Vol. 5, “Consolidated Guidance About Materials Licenses: ProgramSpecific Guidance About Self-Shielded Irradiator Licenses” and Vol. 6, “Consolidated 

Guidance About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 

Irradiator Licenses,” for additional guidance.

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.
F–5

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 microgray/hour (μGy/h) [0.1 millirad/hour (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 mCi (millicuries)] of cesium-137 or 780 megabecquerels 

[21 mCi] 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 radiation 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 

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 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 Gray/h [1,000 Rad/h]; ±x = ±10%
F–6

• 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/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.

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 type of radiation(s) 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%

• 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 
F–7

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 a radioactive sealed source(s). These should be suitable for the geometry of 

the sample(s) to be analyzed. The calibration source(s) should have a known activity(ies) 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, including 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 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 radiation flux 

field and a specified surface of the instrument

• for radiation detectors with removable shielding, an indication as to 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
F–8

• 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

Service providers who will perform calibrations as a commercial service will also include their 

company name and radioactive materials license number on the calibration certificate.

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 

(Regulatory Guide 8.25, Rev. 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.

• 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.
F–9

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.)3

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 percent, 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%

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 

 

3The 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.
F–10

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 

(ADAMS Accession No. ML13051A671)

• The Health Physics and Radiological Health Handbook, 4th Edition. 

Edited by Thomas E. Johnson and Brian K. Birky, dated 2012

• American National Standards Institute (ANSI) N323AB-2013, “American National Standard 

for Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments.” 

Copies may be obtained from the American National Standards Institute (ANSI) at 

www.ansi.org.

• “Air Sampling Instruments,” American Conference of Governmental Industrial Hygienists, 

9th Edition, 2001
APPENDIX G

MODEL LEAK TEST PROGRAM

G–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, gas-flow proportional counters for alpha-emitters].

• If the sensitivity of the counting system is unknown, the minimum detectable activity 

(MDA) will be determined. 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
G–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 non-equal 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.

Leak Testing Kits

Leak-test kits will contain

• for example, swabs, wipes, absorbent-tipped sticks, that are to be used to make the 

wipes on the specified sources or devices

• for example, envelopes, vials, where the leak-test sample will be placed after the sample 

has been taken

• step-by-step instructions for safe use of the particular kit (these instructions will be 

specific to the types of devices/sealed sources that the kit is designed)

• procedures for shipping the sample for analysis

• a label that contains the following information:

— customer’s (or Company) name

— license number

— date leak test was taken
G–3

— source or device (by manufacturer, model number, nuclide and activity) 

— the name of the individual who performed the leak test

Procedure for Performing Leak Testing and Analysis

• Either use a leak test kit or, for each sealed source to be tested, list identifying 

information such as the manufacturer’s name, model number, sealed source serial 

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 an instrument that is sensitive enough to detect 185 Bq [0.005 microcuries] of the 

radionuclide contained in the sealed source.

• Using the selected instrument, count and record background count rate.

• Check the instrument’s counting efficiency using a standard source of the same 

radionuclide as the source being tested or one with similar energy characteristics. The 

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 efficiency.

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 Bq (or millicuries). 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
G–4

• 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 Bq [0.005 microcurie] or greater, notify the radiation safety 

officer (RSO) so that the source can be withdrawn from use and disposed of properly. 

Also, notify the U.S. Nuclear Regulatory Commission (NRC) in accordance with the 

conditions of the license.

Example Notification for a Leaking Source:

Name and mailing address of customer

NRC Regional Office address

Re.: Notice of Leak Test Exceeding 0.005 microcuries [185 becquerels]

Dear Sir or Madam:

Per the requirements of our NRC materials license <insert license number>, I am notifying 

your office of a sealed source that has exhibited a wipe in excess of 0.005 microcuries

[185 becquerels]. The wipe was detected during a scheduled 6-month wipe of our sealed

sources used in the laboratories/room at the address below. The instrument housing the sealed 

source was removed from service.

Following is information provided in accordance with the requirements outlined in 

10 CFR 30.50 (c)(2).

A description of the event, including the probable cause and the manufacturer and model

number (if applicable) of any equipment that failed or malfunctioned.

The high wipe was determined during a routine 6-month wipe of sealed sources. The initial wipe 

result was <insert activity> microcuries on the <insert location wipe tested>. The high wipe was 

reported to the RSO by our service provider.

Possible cause of the high wipe is attributed to .

Manufacturer:<insert manufacturer>

Model Number: <insert model number>

The exact location of the event:

• Lab/Room <insert bldg., lab or room number>

The isotopes, quantities, and chemical and physical form of the licensed material involved:

• Isotope: <insert isotope>

• Quantity: <insert activity of source> 

• Chemical and physical form: <insert sealed or plated, form>
G–5

Date and time of the event:

Date and Time: <insert date and time of event>

Corrective actions taken or planned and the results of any evaluations or assessments <insert 

actions here>

The extent of exposure of individuals to radiation or to radioactive materials without identification 

of individuals by name.

No exposure expected. The sealed source was housed in an enclosed instrument.

Please contact me if you have any questions.

Sincerely,

RSO

APPENDIX H

GUIDANCE FOR DEMONSTRATING THAT UNMONITORED INDIVIDUALS 

ARE NOT LIKELY TO EXCEED 10 PERCENT OF THE ALLOWABLE LIMITS

H–1

Guidance for Demonstrating That Unmonitored Individuals Are Not Likely 

to Exceed 10 Percent of the Allowable Limits

Dosimetry is required for individual adults likely to receive, in 1 year from sources external to 

the body, an occupational dose in excess of 10 percent of the applicable regulatory limits in 

Title 10 of the Code of Federal Regulations (10 CFR) 20.1201, “Occupational dose limits for 

adults.” To demonstrate that dosimetry is not required, a licensee needs to perform a 

prospective evaluation to demonstrate that its adult workers are not likely to exceed 10 percent

of the applicable limits.

The most common way that individuals might exceed 10 percent of the applicable limits is by 

being involved in the processing of sealed sources and/or unsealed material, (e.g., assembly 

lines, manufacturing processes and quality control activities). This could include internal 

radioactive uptake, as well as external radiation exposure. However, for many processes, even 

these activities result in the individual receiving minimal doses. Before allowing workers to 

perform these tasks, a licensee will need to evaluate the doses that its workers might receive to 

assess whether dosimetry is required. This is known as a prospective evaluation.

Example:

A radiation measurement of the work area indicates a dose rate of 0.015 mSv/h [1.5 mrem/h]. 

Service provider personnel are not expected to spend more than a total of 6 hours per week at 

the location of the measurement. Based on this measured dose rate, the annual dose is 

expected to be less than 4.68 mSv [468 mrem]. Specifically, 6 h/wk × 1.5 mrem/h × 52 wk/yr = 

468 mrem. Based on the above, if any service personnel work in the area less than 6 hours per 

week, no dosimetry is required. If the service personnel work in the area for greater than 

6 hours per week, then dosimetry is required. The threshold for monitoring is 10 percent 

[500 millirems] of the applicable limit (for personnel with an annual dose limit of 5,000 millirems). 

Guidance to Licensees

Licensees who wish to demonstrate that they are not required to provide dosimetry to their 

workers need to perform prospective evaluations similar to the example provided above. The 

expected dose rates, times, and distances used in the above example may not be appropriate 

to individual licensee situations. In their evaluations, licensees will use information appropriate 

to the type of work being conducted.

Table H–1 may be helpful in performing a prospective evaluation for external exposure and 

provides an example of the documentation to show that unmonitored individuals will not exceed 

10 percent of the allowable dose limits.

For guidance on determining internal occupational dose and summation of occupational dose, 

refer to Regulatory Guide 8.9, “Acceptable Concepts, Models, Equations, and Assumptions for a 

Bioassay Program,” and Regulatory Guide 8.34, “Monitoring Criteria and Methods to Calculate 

Occupational Radiation Doses.”

Licensees should review evaluations periodically and revise them, as needed. They need to 

check assumptions used in their evaluations to ensure that the assumptions are up-to-date and 

accurate, especially when there is an increase in the possession of radioactive material.
H–2

Table H–1. Dosimetry Evaluation

Dosimetry Evaluation for ___________________ 

A. Time needed to perform the entire work 

activity

_________ minutes _________ hour

(divide # of 

minutes by 60)

B. Expected whole body dose rate that the 

individual will encounter, determined using 

measured or manufacturer-provided data

____________ millirem/hour

C. Time the extremities were exposed to the 

unshielded source (if applicable)

_________ minutes _________ hour

D. Expected extremity dose rate that the 

individual will encounter, determined using 

measured or manufacturer-provided data for 

the unshielded source at the typical distance 

from the hands to the unshielded source

____________ millirem/hour

Estimated Whole Body Dose Equivalent*

Formula: (_____hours in Row A) × (______millirem/hour in Row B) = (_____estimated millirem) 

× (_____# times conducted each year) = _______ millirem

Estimated Extremity Dose Equivalent†

Formula: (_____hours in Row C) × (______millirem/hour in Row D) = (_____estimated 

millirem) × (_____# of times conducted each year) = _______ millirem

*An expected Whole Body Dose Equivalent less than 500 millirem requires no dosimetry.

†An expected Extremity Dose Equivalent less than 5,000 millirem requires no dosimetry.
APPENDIX I

GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL MEMBERS OF THE 

PUBLIC WILL NOT RECEIVE DOSES EXCEEDING THE ALLOWABLE LIMITS

I–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 dose to members of the public.

Licensees must ensure that:

• The radiation dose received by individual members of the public does not exceed 1 mSv 

[100 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 materials to the environment, excluding radon-222 and its 

daughters, do not result in doses greater than 0.1 mSv [10 mrem] per year total effective 

dose equivalent (TEDE). As required by 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.

Table I–1. Doses to Members of the Public

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

• air 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
I–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 non-radioactive materials, and other facilities and laboratories where licensed 

materials are not normally used or stored. 

The licensee may show compliance with the annual dose limit for individual members of the 

public by:

• demonstrating by measurement or calculation that the total effective dose equivalent 

(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

• 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; and 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 

[0.05 rem] in 1 year

• demonstrating that air emissions of radioactive materials do not result in doses greater 

than the constraint limit of 0.1 mSv [10 mrem] TEDE

• demonstrating by measurement or calculation that the TEDE to an individual will not 

exceed 0.02 mSv [2 mrem] in any one hour at an established boundary for 

temporary jobsites

To perform a dose assessment, licensees 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 their facilities. Licensees 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 effluent

The method used to measure dose will depend upon 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 
I–3

over time. If the source of radiation differs or changes over time, it may be necessary to 

perform continuous measurements.

Radioactivity releases may be determined by effluent monitoring or by effluent sampling and 

analysis. Airborne effluents may be discharged when volatile materials are used, such as 

during waste compactions or incinerations, but the discharge itself 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 at the boundary of the unrestricted area. 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 I–2 or may calculate a specific occupancy factor by determining 

the likely fraction of time that the individual is present. The occupancy factors in Table I–2 are 

general guidance values and may be used if more detailed information is not available.
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Table I–2. 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 Rooms used for patient examinations and treatments and similar areas 

where individuals are present for a major part of the day

1/5 Corridors, employee lounges, staff rest rooms, patient rooms, and 

classrooms

1/20 Unattended waiting rooms, public rest rooms, unattended vending rooms, 

storage areas, janitor’s closets, attics, outdoor areas with seating, patient 

holding areas, 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 will identify the 

instruments used in the survey, the name of the surveyor, the date of the survey, the location of 

the survey(s), including a description or drawing of the area 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.

Service provider licensees who perform tracer flow studies at temporary jobsites must maintain 

records in accordance with 10 CFR 32.12, “Same: Records and material transfer reports,” and 

10 CFR 32.52, “Same: Material transfer reports and records.”

The following is a simple example to demonstrate the above concepts for calculating direct 

measurement with sensitive instrumentation and combination of calculating and measurement.

 

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.
I–5

Recordkeeping

Regulations in 10 CFR 20.2107 “Records of dose to individual members of the public,” require

licensees to maintain records demonstrating compliance with the dose limits for individual 

members of the public.

Calculation Method2

These measurements must be made with calibrated radiation survey meters sufficiently 

sensitive to measure background levels of radiation. However, licensees must exercise caution 

when making these measurements, and they must use currently calibrated radiation survey 

instruments. A maximum dose of 1 mSv [100 mrem] received by an individual over a period of 

2080 hours (i.e., a “work year” of 40 h/wk for 52 wk/yr) is equal to less than 0.5 microsievert 

[0.05 mrem] per hour.

This rate is well below the minimum sensitivity of most commonly available Geiger-Mueller

survey instruments.

Figure I–1. Bird’s-Eye View of Office with Stored Calibration Source

 

2For ease of use, the examples in this Appendix use conventional units. The conversions to International System of 

Units units are as follows: 1 foot (ft) = 0.305 meter; 1 mrem = 0.01 mSv.
I–6

Instruments used to make measurements for calculations must be sufficiently sensitive. An 

instrument equipped with a scintillation-type detector [e.g., NaI(Tl)] or a micro-Roentgen meter 

used in making very low gamma radiation measurements should be adequate.

Licensees may also choose to use environmental thermoluminescent dosimeters (TLDs) in 

unrestricted areas next to the down-hole source storage area for monitoring. This direct 

measurement method would provide a definitive measurement of actual radiation levels in 

unrestricted areas without any restrictive assumptions. Records of these measurements can 

then be evaluated to ensure that rates in unrestricted areas do not exceed the 1 mSv/yr 

[100 mrem/yr] limit.

TLDs used for personnel monitoring (e.g., LiF) may not have sufficient sensitivity for

environmental monitoring. Generally, the minimum reportable dose received is 0.1 mSv 

(10 mrem). Suppose a TLD monitors dose received and is changed once a month. If the 

measurements are at the minimum reportable level, the annual dose received could have 

been about 1.2 mSv [120 mrem], a value in excess of the 1 mSv/yr [100 mrem/yr] limit. If 

licensees use TLDs to evaluate compliance with the public dose limits, they may need to

consult with their TLD supplier and choose more sensitive TLDs, such as those containing 

CaF2 that are used for environmental monitoring.

The combined measurement-calculation method may be used to estimate the maximum dose to 

a member of the public. The combined measurement-calculation method takes a tiered 

approach, going through a two-part process, starting with a worst-case situation and moving 

toward more realistic situations. It makes the following simplifications: (i) each cesium-137 

source is considered a point source; (ii) typical radiation levels are encountered when the 

source is in the unshielded position; and (iii) no credit is taken for any shielding found between 

the source storage area and the unrestricted areas. The method is only valid for the source 

activity at the time of measurement and must be repeated if the source strength or shielding 

is changed.

Part 1 of the combined measurement-calculation method is simple but conservative. It assumes 

that an affected member of the public is present 24 hours a day and uses only the inverse 

square law to determine if the distance between the down-hole storage area and the affected 

member of the public is sufficient to show compliance with the public dose limits. Part 2 

considers not only distance, but also the time that the affected member of the public is actually 

in the area under consideration. Using this approach, licensees make only those calculations 

that are needed to demonstrate compliance. The results of these calculations typically result in 

higher radiation levels than would exist at typical facilities, but they provide a method for 

estimating conservative doses that could be received.

Example

To better understand the combined measurement-calculation method, we will examine DISPOZ, 

Inc., a waste management broker. Yesterday, the company’s president noted that the top shield 

of the down-hole storage area is close to an area used by workers whose assigned duties do 

not include the use of licensed materials, and he asked Jenny, the radiation safety officer 

(RSO), to determine if the company is complying with U.S. Nuclear Regulatory Commission

(NRC) regulations.

The area in question is near the floor under the workers’ desks, which constitutes the primary 

shield of the down-hole storage area. Jenny measures the distance from the shield to the 
I–7

Figure I–2. Down-Hole Storage Array in Waste Broker Facility

center of the area in question and, using a calibrated survey instrument, measures the highest 

dose rate at 1 foot from the shield to be 2 mrem per hour.

Table I–3 summarizes the information Jenny has on the down-hole storage area.

Table I–3. Information Known about Dose at the Shield of the Cs-137 Source

Description of Known Information Cesium-137 Logging Source

Dose rate encountered at 1 foot from the top of the shield, in 

mrem/h

2 mrem/h

Distance from the face of the shield to the nearest occupied 

work area, in ft.

4 ft

Example: Part 1

Jenny’s first thought is that the distance between the down-hole storage area shield and the 

area in question may be sufficient to show compliance with the regulation in 10 CFR 20.1301, 

“Dose limits for individual members of the public.” So, taking a worst-case approach, she 

assumes: (i) the cesium-137 is constantly located in down-hole storage area (i.e., 24 h/day); 

and (ii) the workers are constantly in the unrestricted work area (i.e., 24 h/day). Jenny proceeds 

to calculate the dose the workers might receive hourly and yearly from the source, as shown in 

Table I–4 below.
I–8

Table I–4. Calculation Method, Part 1: Hourly and Annual Doses Received From a 

Source Stored Above Ground

Step

No. Description Input Data Results

1 Multiply the measured dose rate measured at 1.0 ft 

from the face of the shield floor in mrem/h by the 

square of the distance (ft) at which the measurement 

was made (e.g., 1 ft from the face of the shield).

2 × (1)2 2

2 Square of the distance (ft) from the face of the shield 

to the nearest unrestricted area, in ft2

(4)2 16

3 Divide the result of Step 1 by the result of Step 2 to 

calculate the dose received by an individual in the 

area near the shield. HOURLY DOSE RECEIVED 

FROM SOURCE, in mrem in an hour.

2/16 0.125

4 Multiply the result of Step 3 by 40 h/work week× 52 

weeks/year = MAXIMUM ANNUAL DOSE RECEIVED 

FROM Cs-137 Source, in mrem in a year.

0.125 × 40 × 52 260

Note: The result in Step 3 demonstrates compliance with the 2 mrem in any 1-hour limit. 

Reevaluate if assumptions change. If the result in Step 4 exceeds 100 mrem/yr, proceed to 

Part 2 of the calculation method.

At this point, Jenny is pleased to see that the total dose that an individual could receive in any 

1 hour is only 0.125 mrem in 1 hour, less than the 2 mrem in any 1 hour limit but notes that an 

individual could receive a dose of 260 mrem in 1 year, higher than the 100 mrem limit.

Example: Part 2

Jenny reviews the assumptions and recognizes that the workers are not in the area all of the 

time. A realistic estimate of the number of hours the workers spend in the area is made, 

keeping the other assumptions constant [i.e., the source is constantly in the down-hole storage 

area (i.e., 24 h/day)]. The annual dose received is then recalculated.
I–9

Table I–5. Calculation Method, Part 2: Annual Dose Received From a Source Stored

Above Ground

Step

No.

Description Results

7 A. Average number of hours per day an individual spends in 

area of concern (e.g., a nonradiation worker spends 

1.5 h/day in the area near the shield); the remainder of the 

day the workers are away from the area assigned to jobs 

unrelated to radiation (e.g., painting, grounds keeping, desk 

jobs)

B. Average number of days per week in area

C. Average number of weeks per year in area (e.g., full-time 

workers)

1.5

5

52

8 Multiply the results of Step 7.A. by the results of Step 7.B. by the 

results of Step 7.C. = AVERAGE NUMBER OF HOURS IN 

AREA OF CONCERN PER YEAR.

1.5 × 5 × 52 = 390

9 Multiply the results in Step 3 by the results of Step 8 = ANNUAL 

DOSE RECEIVED FROM CESIUM-137 LOGGING SOURCE 

CONSIDERING REALISTIC ESTIMATE OF TIME SPENT IN 

AREA OF CONCERN, in mrem in a year.

0.125 × 390 = 49

Jenny is pleased to note that the calculated annual dose received is significantly lower and does 

not exceed the 100 mrem in 1 year limit.

Jenny is glad to see that the results in Step 9 show compliance with the 100 mrem in 1 year 

limit. Had the result in Step 9 been higher than 100 mrem in 1 year, then Jenny could have 

done one or more of the following:

• Consider whether the assumptions used to determine occupancy are accurate, revise 

the assumptions as needed, and recalculate using the new assumptions.

• Calculate the effect of any shielding located between the storage area and the floor of 

the public area—such calculation is beyond the scope of this Appendix.

• Take corrective action (e.g., change work patterns to reduce the time spent in the area 

near the shield) and perform new calculations to demonstrate compliance.

• Designate the area inside the use area as a restricted area and the workers as 

occupationally exposed individuals. This would require controlling access to the area for 

purposes of radiation protection and training the workers as required by 10 CFR 19.12, 

“Instruction to workers.”

Note that in the example Jenny evaluated the unrestricted area outside only one wall of the 

down-hole storage area. Licensees also need to make similar evaluations for other unrestricted 
I–10

areas and to keep in mind the as low as is reasonably achievable (ALARA) principle, taking 

reasonable steps to keep radiation dose received below regulatory requirements. 

In addition, licensees should be alert to changes in situations (e.g., adding sources to the 

storage area, changing the work habits of the workers, or otherwise changing the estimate of 

the portion of time spent in the area in question) and will perform additional evaluations, as 

needed.

Reference:

National Council on Radiation Protection and Measurements (NCRP) Report No. 151, 

“Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy 

Facilities (2005).”
APPENDIX J

U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS

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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 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
J–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

— 9 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
J–3

• 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.
J–4

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/nonexclusive use[9]

IP-3: nonexclusive 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. 
J–5

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.
J–6

 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.
J–7

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.
J–8

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 

square-on-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., RADIOACTIVELSA, 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.
J–9

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.
J–10

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 (1001 pounds) or more gross 

weight of non-fissile, 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).
J–11

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/outreachtraining/erg.
J–12

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 K

INFORMATION NEEDED TO SUPPORT APPLICANT’S REQUEST TO 

PERFORM NONROUTINE MAINTENANCE CHECKLIST

K–1

Information Needed to Support Applicant’s Request to Perform Nonroutine 

Maintenance Checklist

Applicants should review the section in this document on “Maintenance,” which discusses, in 

general, licensee responsibilities before any maintenance or repair is performed.

Routine maintenance is maintenance that the manufacturer or distributor allows their customers 

to perform in accordance with instructions in the user manual. Nonroutine maintenance is 

maintenance that requires specialized training and experience. Nonroutine operations include 

installation of the sealed source/device, repair or maintenance involving or potentially affecting 

components, including electronics, related to the radiological safety (e.g., the source, source 

holder, source drive mechanism, shutter, shutter control, or shielding), relocation, replacement, 

and disposal of sealed sources, alignment, removal of a sealed source/device from service, 

and any other activities during which personnel could receive radiation doses exceeding 

U.S. Nuclear Regulatory Commission (NRC) limits.

The service provider may obtain replacement parts from the manufacturer/distributor or have its 

customer order the parts from the manufacturer/distributor. If neither the service provider nor 

the customer can obtain a replacement part from the manufacturer or distributor, the service 

provider may purchase a part from another vendor or fabricate the part. 

It is preferable to use the original equipment manufacturer or distributor (OEM) supplied

components or parts. Any non-OEM replacement components or parts, or the use of materials 

(e.g., lubricants) other than those specified or recommended by the manufacturer or distributor

will need to be evaluated to ensure that they do not degrade the results of the engineering 

safety analysis performed and accepted as part of the device sealed source and device (SSD)

registration. If the service provider uses a part integral to the safe operation of the device that 

has not been provided by the manufacturer, the service provider will verify that the part will have 

the commensurate form, fit, and function as the original component. In addition, the service 

provider will provide the information related to the form, fit, and function of a non-OEM part (as 

specified in Section 8.10.9 “Maintenance”) to the customer, and the customer will provide the 

technical information to the NRC for a safety review. The use of replacement parts may result 

in the device being a custom device in accordance with NUREG–1556, Volume 3, 

“Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device 

Evaluation and Registration.” The service provider will not install this part until verifying that its 

customer has retained the appropriate authorization to proceed. Licensees will also ensure 

that, after maintenance or repair is completed, the sealed source/device is tested and functions 

as designed, before the unit is returned to routine use.

For guidance on the use of sources that have not been supplied by the manufacturer and/or 

distributor, see Regulatory Issue Summary 2013-01, March 12, 2013 (ADAMS Accession No. 

ML12313A147).

If nonroutine operations are not performed properly with attention to good radiation safety 

principles, the sealed source/device may not operate as designed and personnel performing 

these tasks could receive radiation doses exceeding NRC limits.

Thus, applicants wishing to perform nonroutine operations must use personnel with special 

training and follow appropriate procedures consistent with the manufacturer’s or distributor’s 

instructions and recommendations that address radiation safety concerns (e.g., use of radiation
K–2

survey meter, shielded container for the source, and personnel dosimetry (if required)). 

Accordingly, provide the following information.

Describe the types of work, maintenance, cleaning, or repair that involve:

• installation, relocation, or alignment of the sealed source/device

• components, including electronics, related to the radiological safety of the device

(e.g., the source, source holder, source drive mechanism, shutter, shutter control, 

or shielding)

• replacement and disposal of sealed sources

• removal of a sealed source/device from service

• a potential for any portion of the body to come into contact with the primary 

radiation beam

• any other activity during which personnel could receive radiation doses exceeding 

NRC limits

The principal reason for obtaining this information is to assist in the evaluation of the 

qualifications of individuals who will conduct the work and the radiation safety procedures they 

will follow.

• Identify who will perform nonroutine operations and their training and experience. 

Acceptable training would include manufacturer’s or distributor’s courses for nonroutine 

operations or equivalent.

• Verify that the maintenance activities are authorized on the license.

• Submit operating and emergency procedures for nonroutine operations. These 

procedures will ensure the following:

— Doses to personnel and members of the public are within regulatory limits and as 

low as is reasonably achievable (ALARA) (e.g., use of shielded containers or 

shielding).

— The source is secured against unauthorized removal or access or under constant 

surveillance.

— Appropriate labels and signs are used.

— Manufacturer’s or distributor’s instructions and recommendations are followed.

— Any nonmanufacturer/nondistributor supplied replacement components or parts, 

or the use of materials (e.g., lubricants) other than those specified or 

recommended by the manufacturer or distributor are evaluated to ensure that 

they do not degrade the engineering safety analysis performed and accepted as 

part of the device registration.
K–3

— Before being returned to routine use, the sealed source/device is tested to verify 

that it functions as designed and source integrity is not compromised.

• Ensure emergency procedures will be developed and reviewed for all likely accident 

scenarios.

• Confirm that individuals performing nonroutine operations will wear both whole body and 

extremity monitoring devices or perform a prospective evaluation demonstrating that 

unmonitored individuals performing nonroutine operations are not likely to receive, in a

year, a radiation dose in excess of 10 percent of the allowable limits.

• Verify possession of at least one survey instrument that meets the criteria in Appendix F 

of this document.

• Describe steps to be taken to ensure that radiation levels in areas where nonroutine 

operations will take place do not exceed the limits in Title 10 of the Code of Federal 

Regulations (10 CFR) 20.1301, “Dose limits for individual members of the public.” For 

example, applicants can do the following:

— Commit to performing surveys with a survey instrument (as described above).

— Specify where and when surveys will be conducted during nonroutine operations.

— Commit to maintaining, for 3 years from the date of the survey, records of the 

survey (e.g., who performed the survey, date of the survey, instrument used, 

measured radiation levels correlated to location of those measurements), as 

required by 10 CFR 20.2103.

• Commit to providing the customer a service report describing the work that was 

completed, especially replacement parts and/or sources.

APPENDIX L

SUGGESTED SERVICE PROVIDER AUDIT CHECKLIST

L–1

Suggested Service Provider Audit Checklist

An audit is conducted, in part, to fulfill the requirements of Title 10 of the Code of Federal 

Regulations (10 CFR) 20.1101, “Radiation protection programs,” for a periodic review, at least 

annually, of the content and implementation of the licensee’s radiation protection program. 

Audits should also identify program weaknesses and allow licensees to take early corrective 

actions [before a U.S. Nuclear Regulatory Commission (NRC) or Agreement State inspection

identifies the weaknesses]. During an audit, the auditor [e.g., radiation safety officer (RSO)], 

management representative, and consultant should keep in mind not only the requirements of 

NRC’s regulations, but also the licensee’s commitments in its applications and other 

correspondence with 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.

Licensee management should conduct performance-based reviews by observing work in 

progress, interviewing staff, and spot-checking required records. As a part of applicants’ audit 

program, applicants should consider performing unannounced audits to determine if, for 

example, Safe Use and Emergency Procedures are available and are being followed.

The form in this Appendix can be used to document the audit of the radiation protection 

program. Guidance follows on completing each section of the form. In the “remarks” portions of 

the form, note any deficiencies that were identified and the corrective actions taken (or to be 

taken), and timeframe for completion.

Section 1, Audit History. Enter the date of the last audit, whether any deficiencies were 

identified, whether actions were taken to correct the deficiencies, and whether the corrective 

actions were effective.

Section 2, Organization and Scope of Program. Give a brief description of the organizational 

structure. Note any changes in personnel, operating and emergency procedures, or

amendments to the license. Describe the scope of licensed activities at the audited location. 

Check whether the RSO is the person identified in the license and fulfills the duties specified in 

the license. Notify the NRC promptly, and in writing, when no principal activities under the 

license have been conducted for a period of 24 months, in accordance with 10 CFR 30.36(d),

10 CFR 40.42(d), or 10 CFR 70.38(d), and complete an audit.

Section 3, Training, Retraining, and Instructions to Workers. Ensure that workers have 

received the training required by 10 CFR 19.12, “Instruction to workers.” Be sure that, before 

being permitted to use licensed material, the user has received training and has a copy of the 

licensee’s safe use and emergency procedures. 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 and/or observation of selected workers, that the individual can 

implement them. Records will be maintained.

Section 4, Internal Audits, Reviews, or Inspections. 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 

licensing documents.
L–2

Section 6, Materials. Verify that the license authorizes the quantities and types of byproduct, 

source, and/or special nuclear material that the licensee possesses. Verify whether financial 

assurance is or is not needed, based on possession limits on the license and whether financial 

instruments are still valid or need revision.

Section 7, Leak Tests. Verify that all sealed/plated foil sources are tested for leakage at the 

prescribed frequency described in the Sealed Source and Device registration certificate, and in 

accordance with licensee commitments. Records of results will be maintained.

Section 8, Inventories. Verify that physical inventories are conducted at least once every 

6 months to account for all sources; inventory records will be maintained. In addition, licensees 

in possession of nationally tracked sources must complete an annual reconciliation inventory in 

accordance with 10 CFR 20.2207, “Reports of transactions involving nationally tracked 

sources.”

Section 9, Radiation Surveys. Verify that the licensee has appropriate, operable, and 

calibrated survey instruments available, that the instruments are calibrated periodically in 

accordance with 10 CFR 20.1501, “General,” and in accordance with license conditions. 

Calibration records must be retained for 3 years after the record is made, in accordance with 

10 CFR 20.2103, “Records of surveys.” Check that radiation levels in areas adjacent to use are 

within regulatory limits. Verify compliance with 10 CFR 20.1301, “Dose limits for individual 

members of the public.” 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 containing licensed material, received from others, 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, “Transfer of 

byproduct material.” 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, or 10 CFR 70.51,

as applicable.

Section 11, Transportation. Determine compliance with U.S. Department of Transportation 

(DOT) requirements. Verify that radioactive packages are prepared, marked, and labeled in 

accordance with 49 CFR Parts 172 and 173 requirements. Verify that shipping papers are 

prepared, that they contain all needed information, and that they are readily accessible during 

transport [49 CFR 172.200, 201, 202, 203, 204 and 177.817(e)]. Verify that any import and/or 

export of licensed material is conducted in accordance with the requirements set forth 

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

Section 12, Personnel Radiation Protection. Evaluate the licensee’s assessment that 

unmonitored occupational workers are not likely to receive more than 10 percent of the 

allowable limits (i.e., 500 millirem in a year). 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; determine 

reasons for significant differences in exposures. If any worker voluntarily declares her 

pregnancy in writing, evaluate the licensee’s compliance with 10 CFR 20.1208, “Dose 

equivalent to an embryo/fetus.” Check whether records are maintained, as required by 

10 CFR 20.2101, 2102, 2103, 2104, and 2106.
L–3

Section 13, Security Program for Category 1 and Category 2 Materials. Conduct a handson and record-review of the licensee’s physical protection program, to verify the licensee’s 

compliance with 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 

Quantities of Radioactive Material. NUREG–2155, “Implementation Guidance for 10 CFR 

Part 37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,””

contains useful information. Licensees may propose alternative ways for demonstrating 

compliance with these requirements.

Section 14, Auditor’s Independent Measurements (If Made). Make independent survey 

measurements and compare the results with those made or used by the licensee.

Section 15, Radioactive Effluents, Waste Management and Disposal. Determine if 

radioactive effluents and radioactive waste are properly disposed and records maintained.

Section 16, Notification and Reports. Check to determine the licensee’s compliance with the 

notification and reporting requirements in 10 CFR Parts 19, 20, 21, 30, 31, 32, 33, 34, 35, 36, 

37, 39, 40, 70, and 71. Ensure that the licensee is aware of the telephone number for NRC’s 

Emergency Operations Center; 301–816-5100.

Section 17, 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 18, Recordkeeping for Decommissioning. Check to determine compliance with 

10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g), as appropriate. The 

Decommissioning Planning Rule [76 FR 35512 (June 17, 2011,)] requires licensees to minimize 

contamination released into the site, and to identify the location and amount of significant 

residual radioactivity throughout the facility and site, including in the subsurface. The results of 

these surveys must be documented in records important to decommissioning if the identified 

contamination will require remediation to meet the unrestricted use criteria of 10 CFR 20.1402, 

“Radiological criteria for unrestricted use.” 

Section 19, NRC Correspondence. Check to determine if the licensee is receiving such 

documents as regulatory issue summaries, bulletins, information notices, and Office of Nuclear 

Material Safety and Safeguards (NMSS) Newsletters, from the NRC. Check whether the 

licensee took appropriate action in response to NRC mailings.

Section 20, License Conditions or Issues. Verify compliance with conditions on the service 

provider’s license. Review the last license condition to determine if all documents listed should 

remain on the license or be revised. 

Section 21, Performance-based Review. Performance-based reviews may be conducted by 

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

the audit program, consider performing unannounced audits to determine if, for example, Safe 

Use and Emergency Procedures are available and are being followed. The NRC conducts 

performance-based observations during inspections and encourages licensees to also observe 

licensed activities in process as part of the audit review.

Section 22, Problems or Deficiencies Noted and Recommendations. Note any 

deficiencies that were identified and the corrective actions taken (or to be taken) and 

timeframe for completion.
L–4

Section 23, 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.

Sample Audit Checklist

Audit Report No._________________________ License No.____________________

Licensee’s name and mailing address:

 

 

 

 

Audit of licensed activities at [Address(es)]:

 

 

 

Contact at Audit Location ____________________________ Telephone No.______________ 

Date of this Audit 

Summary of Findings and Action:

 No deficiencies

 Deficiencies



Indicate if corrective actions taken to prevent recurrence from the previous audit were 

comprehensive and effective recommendations:

Auditor:________________________________________ Date: _____________________

 (Signature)
L–5

Note: Except where noted, references are to Title 10 of the Code of Federal Regulations 

(10 CFR).

1. AUDIT HISTORY  N/A (N/A means “Not applicable” – Initial Audit)

a. Last audit of this location conducted on: ____________

b. Problems/deficiencies identified during last two audits or two years, 

whichever is longer........................................................................................... Y  N

c. Open problems/deficiencies from the 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

b. Structure is as described in license documents ................................................ Y  N

c. Operating and Emergency Procedures are up to date and have been 

submitted to the NRC .........................................................................  Y  N  N/A

d. Multiple authorized locations of use listed ........................................................ Y  N

Provide address(es) of those locations reviewed as part of this audit:

e. Briefly describe scope of activities involving licensed material, frequency 

of use, staff size

f. Radiation Safety Officer:

Authorized on license ....................................................................................... Y  N

Fulfills duties as RSO ....................................................................................... Y  N
L–6

g. Use of licensed material only by authorized individuals .................................... Y  N

Remarks:

3. TRAINING, RETRAINING, AND INSTRUCTIONS TO WORKERS

a. Instructions to workers per [10 CFR 19.12]....................................................... Y  N

b. Training program implemented as required [L/C1

] ............................................ Y  N

c. Training records maintained [L/C]..................................................................... Y  N

d. Evaluation of individuals’ understanding of procedures and requirements 

based on interviews, observation of selected workers was performed..............  Y  N

If so:

Each has an up-to-date copy of the licensee’s operating use and emergency 

procedures ....................................................................................................... Y  N

Adequate understanding of:

Operating procedures ................................................................................. Y  N

Emergency procedures............................................................................... Y  N

e. 10 CFR Part 20

Workers cognizant of requirements for:

Radiation Protection Program [20.1101] ..................................................... Y  N

Annual dose limits [20.1301, 20.1302] ........................................................ Y  N

NRC Forms 4 and 5.................................................................................... Y  N

10 percent monitoring threshold [20.1502].................................................. Y  N

Dose limits to embryo/fetus and declared pregnant women [20.1208] ........  Y  N

Procedures for opening packages [20.1906]............................................... Y  N

f. 10 CFR Parts 19, 20, 21, 30, 37, 40, 70 and 71 reviewed as applicable...........  Y  N

 

1 L/C refers to license condition.
L–7

Remarks:

4. INTERNAL AUDITS, REVIEWS OR INSPECTIONS

a. Audits are conducted  Y  N

1. Audits conducted by

2. Frequency

b. Content and implementation of the radiation protection program reviewed 

at least annually [20.1101(c)]............................................................................ Y  N

c. Records maintained [20.2102].......................................................................... Y  N

Remarks:

5. FACILITIES

a. Facilities as described in license documents .................................................... Y  N

b. Access to restricted area/licensed material in accordance with 20.1801, 

20.1802 ............................................................................................................ Y  N

Remarks:

6. MATERIALS

a. Isotopes, quantities, model numbers, and use as authorized on license...........  Y  N

b. Using NUREG–1757 Volume 3: Financial Assurance is current ............  Y  N N/A

[10 CFR 30.35, 10 CFR 40.36, 10 CFR 70.25]

Remarks:

7 LEAK TESTS

a. Leak test performed as described in correspondence with NRC 

(leak-test kit; service provider licensee performed and/or analyzed).................  Y  N

b. Frequency: every 6 months or other interval, as approved by NRC or 

Agreement State .............................................................................................. Y  N

c. Records with appropriate information maintained ............................................. Y  N

Remarks:
L–8

8. INVENTORIES

a. Conducted at 6-month intervals [L/C] ............................................................... Y  N

b. Visual verification confirmed or security seal still in place ................................. Y  N

c. Transactions entered into the National Source Tracking System, 

including annual reconciliation [10 CFR 20.2207] ................................  Y  N  N/A

d. Records with appropriate information maintained............................................. Y  N

Remarks:

9. RADIATION SURVEYS

a. Instruments and Equipment:

Appropriate operable survey instrumentation possessed or readily 

available [L/C].................................................................................................... Y N

Calibrated as required [20.1501]....................................................................... Y  N

Calibration records maintained [20.2103(a)] ..................................................... Y  N

b. Briefly describe survey requirements [20.1501]:

c. Performed as required [20.1501(a)].................................................................. Y  N

Radiation levels within regulatory limits ............................................................ Y  N

Corrective action taken and documented...............................................  Y  N N/A

d. Records maintained [20.2103].......................................................................... Y  N

e. Protection of members of the public:

Adequate surveys made to demonstrate either (a) that the TEDE to the individual 

likely to receive the highest dose does not exceed 100 mrem in a year, or (b) 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 [20.1301(a)(1), 

20.1302(b)] ................................................................................................. Y  N

 Unrestricted area radiation levels do not exceed 2 mrem in any one hour 

[20.1301(a)(2)]............................................................................................ Y  N

Records maintained [20.2103, 20.2107] ........................................................... Y  N

Remarks:
L–9

10. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL

a. Describe how packages are received and by whom:

b. Written package opening procedures established and followed 

[20.1906(e)]...................................................................................................... Y  N

c. If package shows evidence of degradation, monitor 

for contamination and radiation levels .................................................. Y  N  N/A

d. Monitoring of degraded packages performed within time

specified [20.1906(c)] ........................................................................... Y  N  N/A

e. Transfer(s) between licensees performed in compliance with 30.41, 

40.51, or 70.42, as applicable............................................................... Y  N  N/A

f. Records of receipt/transfer maintained [30.51, 40.61, or 70.51]........................ Y  N

g. Transfers within licensee’s authorized users or locations performed 

as required [L/C]................................................................................... Y  N  N/A

h. Package receipt/distribution activities evaluated for compliance with 

20.1301 [20.1302] ................................................................................ Y  N  N/A

Remarks:

11. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170-189)......................................  N/A

a. Licensee shipments are:

Delivered to common carriers............................................................... Y  N  N/A

Transported in licensee’s own private vehicle.......................................  Y  N  N/A

No shipments since last audit ........................................................................... Y  N

b. Hazmat Training

Applicability and responsibility for training and

testing [49 CFR 172.702]...................................................................... Y  N  N/A

Training requirements [49 CFR 172.704]..............................................  Y  N  N/A

c. Packages............................................................................................................... N/A

Authorized packages used [49 CFR 173.415, 416]...............................  Y  N  N/A
L–10

Closed and sealed during transport [49 CFR 173.475(f)].................................. Y  N

Properly labeled and marked [49 CFR 172.403, 172.441, 173.471]..................  Y  N

d. Shipping Papers ....................................................................................................  N/A

Prepared and used [49 CFR 172.200(a)].......................................................... Y  N

Proper {Shipping Name, Hazard Class, UN Number2

, Quantity, Package 

Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form, 

Activity, Category of Label, Transport Index, Shipper’s Name, Certification and 

Signature, Emergency Response Phone Number, “Cargo Aircraft Only” (if applicable)} 

[49 CFR 172.200-204]...................................................................................... Y  N

Readily accessible during transport [49 CFR 177.817(e)]................................. Y  N

e. Vehicles................................................................................................................. N/A

Cargo blocked and braced [49 CFR 177.842(d)] .............................................. Y  N

Placarded, if needed [49 CFR 172.504]............................................................ Y  N

Proper overpacks, if used (shipping name, UN Number, labeled, 

statement indicating that inner package complies with specification 

package) [49 CFR 173.25].................................................................... Y  N  N/A

f. Security Plans ........................................................................................................ N/A

Components of a security plan [49 CFR 172.802] ......................................  Ye s  No

g. Any incidents reported to DOT [49 CFR 171.15, 171.16].................................. Y  N

Remarks:

12. PERSONNEL RADIATION PROTECTION

a. ALARA considerations are incorporated into the Radiation Protection 

Program [20.1101(b)] ....................................................................................... Y  N

 

2 The UN number identifies the hazardous substance. The UN number is universally recognized and assigned by the 

United Nations.
L–11

b. Adequate documentation of determination that unmonitored 

individuals are not likely to receive >10 percent of 

allowable limit [20.1502(a)]................................................................... Y  N  N/A

OR

c. External dosimetry required and used ..................................................  Y  N  N/A

Supplier: Frequency: 

Supplier is NVLAP-approved [20.1501(d)(1))]..................................................... Y N

Dosimeters exchanged at required frequency [L/C] .......................................... Y  N

d. Occupational intake monitored and assessed [20.1502(b)]...................  Y  N  N/A

e. Reports:................................................................................................................. N/A

Reviewed by: Frequency: 

Auditor reviewed personnel monitoring records for period ___________ to ___________

Prior dose determined for individuals likely to receive doses [20.2104].............  Y  N

Maximum exposures TEDE: Other: 

f. NRC Forms or equivalent [20.2104(d), 20.2106(c)]: 

NRC-4 “Cumulative Occupational Exposure History” Complete:....................... Y  N

NRC-5 “Occupational Exposure Record for a Monitoring Period” Complete: ....  Y  N

g. Worker declared her pregnancy in writing during audit period 

(review records)....................................................................................❒ Y  N  N/A

If yes, determine compliance with 20.1208 ........................................................Y  N

and check for records per 20.2106(e)............................................................... Y  N

h. Records of exposures, surveys, monitoring, and evaluations maintained 

[20.2102, 20.2103, 20.2106, L/C] ..................................................................... Y  N

i. Pocket dosimeters and/or alarming rate meters [L/C]: ..........................................  N/A

Possessed and used as required...................................................................... Y  N

Operable and calibrated/checked at required frequency................................... Y  N
L–12

Records maintained.............................................................................. Y  N  N/A

Remarks:

13. SECURITY PROGRAM FOR CATEGORY 1 AND CATEGORY 2 MATERIALS

 [10 CFR Part 37]

a. Commensurate security program implemented ............................... Y  N  N/A

b. Trustworthiness and Reliability Determinations Made....................................... Y  N

c. Access Control to information and Category 1 or Category 2 radioactive material Y 

N

d. Monitoring/Detection/Assessment/Response Operational 24/7 ............ Y  N  N/A

e. Valid test of security system to ensure operability ........................... Y  N  N/A

f. Local Law Enforcement Agency Coordination and Written Plan ......... Y  N  N/A

g. Package tracking for transport of Category 1 or Category 2 radioactive material ... Y 

 N  N/A

h. Mobile devices secured ......................................................................... Y  N  N/A

i. Sensitive information secured and only available to personnel 

who have been deemed trustworthy and reliable.............................................. Y  N

j. Reports made (loss, theft, or sabotage of Category 1 or Category 2 radioactive material, 

or if results of fingerprints are 

positive for the FBI Terrorist Screening Data, etc.) .......................................... Y  N

k. Records maintained.......................................................................................... Y  N

Remarks:

14. AUDITOR’S INDEPENDENT MEASUREMENTS (IF MADE)

Survey instrument Serial No. Last calibration

_______________________ _________________ _______________

Auditor’s measurements compared to licensee’s.................................................... Y  N

Describe the type, location, and results of measurements; attach a diagram/survey sheet 

and refer to this section:
L–13

15. RADIOACTIVE EFFLUENTS, WASTE MANAGEMENT, AND DISPOSAL

a. Waste disposed of by decay-in-storage (DIS):.......................................................  N/A

Procedure for DIS disposal approved by license condition ............................... Y  N

Disposal by DIS in accordance with L/C ........................................................... Y  N

Licensee in compliance with 20.1501 and 20.1904(b) ...................................... Y  N

Records maintained [20.2103(a), L/C] .............................................................. Y  N

Remarks:

b. Licensed material released into sanitary sewerage:...............................................  N/A

Material is readily soluble (or is readily dispersible biological material) in 

water [20.2003(a)(1)]........................................................................................ Y  N

Monthly average release concentrations do not exceed Appendix B values

[20.2003(a)(2,3)]............................................................................................... Y  N

No more than 5 curies of hydrogen-3,1 curie of carbon-14 and 1 curie of all other

radionuclides combined were released in a year [20.2003(a)(4)]......................  Y  N

Procedures for ensuring adequate sample representativeness and analysis 

properly implemented [20.1501, L/C]................................................................ Y  N

Records maintained [20.2108].......................................................................... Y  N

Remarks:

c. Waste disposed of by incineration: ........................................................................  N/A

License authorizes incineration [20.2004(a)(3)] ................................................ Y  N

If licensee directly monitors incinerator exhaust, the monitor sample 

is representative and the monitoring instrumentation is operational and 

properly calibrated [20.1501] ................................................................ Y  N  N/A

If licensee calculates exhaust concentrations, incinerator airflow and 

activities incinerated are accurately known, and the calculations are 

correct [20.1501] .................................................................................. Y  N  N/A
L–14

Management of effluents and ashes in accordance with 20.1301, 

20.1201, 20.1501, 20.2001 and L/C ................................................................. Y  N

Records maintained [20.2108].......................................................................... Y  N

Remarks:

d. Disposal of liquid scintillation (LS) media and/or animal carcasses:.......................  N/A

Licensee disposes of LS media and carcasses contaminated with only H-3 or 

C-14, and at a concentration not exceeding 0.05 μCi/g per gram of media used for LS 

counting or per gram of animal tissue per 20.2005 ........................................... Y  N

Records maintained [20.2108].......................................................................... Y  N

Remarks:

e. Transfers for disposal at land disposal facilities:....................................................  N/A

Waste transferred to person specifically licensed to receive waste [30.41, 

40.51, 70.42, as applicable, 20.2001(b)]........................................................... Y  N

Each shipment accompanied by a shipment manifest prepared as specified 

in Section I of Appendix G to 10 CFR Part 20 [10 CFR 20.2006(b)

and Section III.A.4 of Appendix G to 10 CFR Part 20] ...................................... Y  N

Shipment manifests certified as specified in Section II of Appendix G to 

10 CFR Part 20 [10 CFR 20.2006(c)] ............................................................... Y  N

Compliance with Section III of Appendix G to 10 CFR Part 20 [10 CFR 20.2006(d)]:

Note: The licensee’s waste is likely to be Class A waste not packaged for 

disposal in cardboard or fiberboard boxes [61.56(a)]

Liquid wastes solidified [61.56(a)]..................................................................... Y  N

Volume of solid wastes contain less than 1 percent freestanding liquid

[61.56(a)(3)]...................................................................................................... Y  N

Waste does not generate harmful vapors [61.56(a)] ......................................... Y  N

Waste structurally stable, i.e., will maintain its physical dimensions and 

form under expected disposal conditions [61.56(b)].......................................... Y  N
L–15

Void spaces within the waste and between the waste and its package 

minimized [61.56(b)]......................................................................................... Y  N

Waste packages labeled to identify their proper class [Section III.A.2 of 

Appendix G to 10 CFR Part 20] ........................................................................ Y  N

Licensee conducts a QA program to ensure compliance with 61.55 and 

61.56, and which includes management evaluation of audits 

[Section III.A.3 of Appendix G to 10 CFR Part 20] ............................................ Y  N

For shipments not acknowledged by recipient within 20 days after 

transfer, incident investigated and reported [Section III.A.9 of 

Appendix G to 10 CFR Part 20] ............................................................ Y  N  N/A

Records maintained [20.2108].......................................................................... Y  N

Remarks:

f. Special disposal procedures and other effluents (e.g., hood exhausts, special 

dilutions):............................................................................................................... N/A

Performed in accordance with L/C.................................................................... Y  N

Appropriate surveys conducted [20.1501, L/C] ................................................. Y  N

Operations comply with 20.1201 and 20.1301.................................................. Y  N

Special disposals per 20.2001 and 20.2002, i.e., no improper/unauthorized 

disposals were noted........................................................................................ Y  N

Use of dose constraint/ALARA [20.1101(d)] .................................................... Y  N

Records maintained [20.2108].......................................................................... Y  N

Remarks:

g. Waste compaction operations: ..............................................................................  N/A

Airborne releases evaluated and controlled [20.1501, 20.1701, L/C] ................  Y  N

Internal exposures evaluated and controlled [20.1501, 20.1204, 20.1702, 

20.1703, 20.1201] ............................................................................................ Y  N
L–16

Compliance with 20.1301 evaluated [20.1302] ................................................. Y  N

Remarks:

h. Waste storage areas: ............................................................................................  N/A

Adequate protection from the elements (floods, tornadoes, hurricanes, etc.) 

and fire [L/C]..................................................................................................... Y  N

Adequate control of waste in storage [20.1801]................................................ Y  N

Containers properly labeled and area properly posted [20.1902, 20.1904] .......  Y  N

Package integrity adequately maintained [L/C]................................................. Y  N

Adequate records of surveys and material accountability are maintained 

[20.2103, 20.2108] ........................................................................................... Y  N

16. NOTIFICATION AND REPORTS ................................................................................  N/A

a. Licensee in compliance with 19.13 (reports to individuals, 

public and occupational, monitored to show compliance with Part 20)..  Y  N  N/A

b. Licensee in compliance with 20.2201 (theft or loss)............................ Y  N  None

c. Licensee in compliance with 20.2202, 30.50, 40.60, 70.50 

(incidents)........................................................................................... Y  N  None

d. Licensee in compliance with 20.2203, 30.50, 40.60, 70.50

(overexposures and high radiation levels) .......................................... Y  N  None

e. Licensee in compliance with 21.21 (device defect).......................... Y  N  None

f. Annual reports furnished to the NRC in compliance

 with 20.2206 (b), (c) (individual monitoring).................................... Ye s  No  N/A

g. Licensee aware of telephone number for NRC Emergency Operations 

Center [301-816-5100] ..................................................................................... Y  N

17. POSTING AND LABELING

a. NRC Form 3 “Notice to Workers” is posted [19.11]........................................... Y  N

b. Parts 19, 20, 21, Section 206 of Energy Reorganization Act, procedures 

adopted pursuant to Part 21, and license documents are posted, or a notice 
L–17

indicating where documents can be examined is posted [19.11, 21.6]..............  Y  N

c. Other posting and labeling per [20.1902, 1904] and the licensee is not 

exempted by 20.1903, 20.1905 ........................................................................ Y  N

Remarks:

18. RECORDKEEPING FOR DECOMMISSIONING ........................................................  N/A

a. Records of information important to the safe and effective decommissioning 

of the facility maintained in an independent and identifiable location until 

license termination............................................................................................ Y  N

b. Records include all information outlined in 30.35(g), 40.36(f), 70.25(g) ............  Y  N

Remarks:

19. NRC CORRESPONDENCE

a. Review of such documents as NRC Regulatory Issue Summaries, Bulletins, 

Information Notices, NMSS Newsletters................................................................. Y  N

b. Appropriate action taken in response to NRC correspondence......................... Y  N

Remarks:

20. LICENSE CONDITIONS OR ISSUES .........................................................................  N/A

a. Review license conditions; NRC/Agreement State violations, Orders, Confirmatory 

Action Letters; site-specific procedures and other safety or security issues, and describe 

findings:

b. Problems/deficiencies identified at licensee facilities other than at audit location:

c. Evaluation of compliance:

21. PERFORMANCE-BASED REVIEW ...........................................................................  N/A

a. Conduct performance-based reviews of radiation workers performing licensed activities:

(1) to assess the capability of the radiation workers to maintain exposures ALARA;

(2) to assess that radiation workers follow the operating procedures;

(3) to assess the effectiveness of the operating procedures and compliance with the 

regulations, license conditions and the licensee commitments submitted in 

support of a license (and incorporated by "tie-down" conditions);

(4) to ensure the safe and secure use of radioactive material;

(5) to verify that radiation workers are cognizant of the emergency procedures and, if 

necessary, would be able to implement them and maintain exposures ALARA; 

and
L–18

(6) to ensure that emergency procedures have been developed for all likely 

scenarios.

b. Take the necessary actions to address programmatic and performance deficiencies with 

radiation workers and facilitate immediate corrective measures.

Note: Performance-based reviews may include observation of licensed activities, review of 

records, and interviews with key personnel.

22. PROBLEMS OR DEFICIENCIES NOTED AND RECOMMENDATIONS.....................  N/A

Note: Briefly state (1) the requirement and (2) how and when violated. Provide corrective 

actions and preventive measures implemented to prevent recurrence. 

23. EVALUATION OF OTHER FACTORS

a. Senior licensee management is appropriately involved with the radiation 

safety program and/or RSO oversight............................................................... Y  N

b. RSO has sufficient time to perform his or her radiation safety duties and is 

not too busy with other assignments................................................................. Y  N

c. Licensee has sufficient staff.............................................................................. Y  N

Remarks:

Note: All areas indicated in audit notes may not be applicable to every license and may not 

need to be addressed during each audit. For example, licensees do not need to address areas 

that do not apply to the licensee’s activities, and activities that have not occurred since the last 

audit need not be reviewed at the next audit. 

Date of This Audit __________________________ Date of Last Audit __________________

Next Audit Date ____________________________

Auditor ___________________________________ Date ___________________

 (Signature)

Management Review ________________________ Date ___________________

 (Signature)
APPENDIX M

MODEL WASTE DISPOSAL PROGRAM

M–1

Model Waste Disposal Program

General Guidelines

• All radioactivity labels must be defaced or removed from containers and packages prior 

to disposal into ordinary “nonradioactive” waste streams. If waste is compacted, all 

labels that are visible in the compacted mass must be defaced or removed.

• Remind workers that nonradioactive waste such as leftover reagents, boxes, and 

packaging material will 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 impact 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, 

inflammability), 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.
M–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 radioisotope in the container, total activity, date when the longest-lived 

radioisotope cannot be distinguished from the background radiation level, 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 the DIS area 

and contact the radiation safety officer (RSO) 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), 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/needles placed into 

sealed waste containers for decay do not need 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/containers; waste 

is incinerated, not placed in a landfill; and the waste disposal firm is cautioned not to open the 

container prior to incineration.
M–3

Model Procedure for Disposal of Liquids into Sanitary Sewerage

• Confirm that the sewer system is a public system, not a private sanitary sewer, septic 

system, or leach field.

• 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 GBq [5 Ci] of H-3 (tritium), 37 GBq [1 Ci] of C-14, 

and 37 GBq [1 Ci] of all other radioisotopes 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.
M–4

Model Procedure for Disposal by Incineration

These guidelines apply to non-commercial waste disposal, i.e., incineration of a licensee’s own 

waste. An applicant or licensee does not need specific U.S. Nuclear Regulatory Commission 

(NRC) approval to incinerate certain categories of radioactive waste. 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. After 

the applicant or licensee reviews its program and confirms that they have waste that requires 

specific NRC approval for incineration, please provide the following information:

• Describe the training and experience of the person who will be responsible for the onsite 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 site location and incinerator, 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 aircleaning 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.
M–5

• 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.

• 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.

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 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 the compactor(s) 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/or 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 method of examining containers for defects.

Nuclear Laundry

Based on 10 CFR 20.2003, “Disposal by release into sanitary sewerage,” a nuclear laundry 

licensee is authorized to dispose of radioactive waste by release into the sanitary sewer. 

Generally, a nuclear laundry licensee is not authorized to possess or transfer for disposal 

radioactive waste, except that generated as a result of laundering activities, such as solid

residue waste from the water treatment or air exhaust systems. The solid residue resulting from 

laundry activities must be disposed of in accordance with license requirements and 

10 CFR 20.2001, “General requirements,” which usually results in transfer to a licensed 

radioactive waste disposal facility.

Solid residue waste, such as sludge and lint from the water treatment or air exhaust systems, 

and process liquids, are considered to be part of the waste generated as a result of the nuclear 
M–6

laundry operation. Rejected laundry items, such as coveralls and rubber shoe covers, which

are unusable or contaminated with residual radioactivity exceeding the preset radiation limits for 

reuse, are returned to the customers for treatment and disposal, in accordance with the 

customers’ waste management program. In some cases, it might be acceptable to conclude 

that zippers, in the case of dissolved disposable protective clothing, are more like residue from 

the laundry process and, therefore, to allow licensed nuclear laundry facilities to send them 

directly for disposal as radioactive waste. The U.S. Nuclear Regulatory Commission (NRC)

finds this approach acceptable. NRC would also find acceptable an approach whereby the 

zippers would be treated like unusable material similar to rejected laundry items, noted above, 

that are returned to the customers for treatment and disposal. Thus, in either case, the NRC 

does not consider a nuclear laundry facility, including one engaged in laundering and dissolving 

of disposable protective clothing, to constitute a waste receipt or processing facility.
APPENDIX N

SAFETY CULTURE STATEMENT OF POLICY

N–1

Safety Culture Statement of Policy

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 

Document and Access Management System (ADAMS) 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.
N–2

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.

(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 O

CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)

O–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 nonproprietary copy of the information. Applicants should white out or black out the 

proprietary portions (i.e., those in the brackets), leaving the nonproprietary portions 

intact. This copy should not be marked as proprietary.

 An affidavit that:

 • Is 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. 18

Revision 1, Final

Consolidated Guidance About Materials Licenses: Program-Specific

Guidance About Service Provider Licenses