Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About

10 CFR Part 36 Irradiator Licenses

Final Report 

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 6, Rev. 1
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Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

10 CFR Part 36 Irradiator Licenses

Final Report 

Manuscript Completed: January 2018

Date Published: January 2018

Prepared by

C. C. Casey

A. Grumbles

W. Lee

R. Ragland

R. J. Torres

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 6, Rev. 1

iii

ABSTRACT

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

assist applicants and licensees in preparing applications for irradiator licenses under Title 10 of 

the Code of Federal Regulations (10 CFR) Part 36, “Licenses and Radiation Safety 

Requirements for Irradiators.” 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, 3150-0001, 3150-0158, 3150-0214, 3150-0020, 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 collection 

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

valid OMB control number.

v

FOREWORD

The U.S. Nuclear Regulatory Commission’s (NRC’s) NUREG–1556 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 6, Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiators,” 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 6, issued January 1999. See 

Appendix A for a list of Information Notices and Regulatory Issue Summaries pertaining to 

Part 36 irradiators.

This report takes a risk-informed, performance-based approach to licensing 10 CFR Part 36 

irradiators. 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 irradiators.

NUREG–1556, Volume 6, 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 staff to make the determinations needed to issue or renew a license.

The comments received during the public comment period for NUREG–1556, Volume 6, 

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

Agencywide Documents and Management System (ADAMS) under ML16103A250. Access to 

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

comments received by NRC included general corrections, comments on training, and requests 

for clarification.

_____________________________________________________

Daniel S. Collins, Director

Division of Material 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8.4 Item 4: Person to be Contacted About This Application ...................................8-4

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

8.5.1 Sealed Sources and Devices................................................................8-4

8.5.2 Financial Assurance and Recordkeeping for Decommissioning............8-6

8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used..........................8-7

8.7 Item 7: Individual(s) Responsible for Radiation Safety Program.......................8-9

8.7.1 Radiation Safety Officer (RSO) Training and Experience......................8-9

8.8 Item 8: Individuals Working in or Frequenting Restricted Areas .....................8-12

8.8.1 Initial Training and Experience for Irradiator Operators.......................8-12

8.8.2 Annual Safety Reviews and Performance Evaluations for

Irradiator Operators ............................................................................8-15

8.8.3 Training for Individuals Who Require Unescorted Access ...................8-17

8.8.4 Training for Individuals Who Must be Prepared to Respond 

to Alarms............................................................................................8-17

8.9 Item 9: Facilities and Equipment ....................................................................8-18

8.9.1 General Description of the Facility and Site.........................................8-18
viii

8.9.2 Access Control ....................................................................................8-22

8.9.3 Shielding .............................................................................................8-25

8.9.4 Fire Protection.....................................................................................8-27

8.9.5 Radiation Monitors ..............................................................................8-28

8.9.6 Irradiator Pools....................................................................................8-30

8.9.7 Source Rack........................................................................................8-32

8.9.8 Power Failures ....................................................................................8-33

8.10 Item 10: Radiation Safety Program ................................................................8-34

8.10.1 Audit and Review of Program..............................................................8-34

8.10.2 Radiation Monitoring Instruments ........................................................8-36

8.10.3 Material Receipt and Accountability.....................................................8-40

8.10.4 Occupational Dosimetry ......................................................................8-43

8.10.5 Public Dose .........................................................................................8-45

8.10.6 Operating Procedures .........................................................................8-47

8.10.7 Procedure for Identifying and Reporting Defects and

Noncompliance as Required by 10 CFR Part 21 .................................8-51

8.10.8 Emergency Procedures.......................................................................8-52

8.10.9 Leak Tests...........................................................................................8-60

8.10.10 Inspection and Maintenance Checks ...............................................8-63

8.10.11 Transportation .................................................................................8-64

8.10.12 Minimization of Contamination.........................................................8-65

8.10.13 Security Program for Category 1 and Category 2 

Radioactive Material ........................................................................8-66

8.11 Item 11: Waste Management .........................................................................8-67

8.11.1 Sealed Source Disposal and Transfer .................................................8-67

8.12 Item 12: Fees.................................................................................................8-68

8.13 Item 13: Certification......................................................................................8-68

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

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

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

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

APPENDICES

APPENDIX A LIST OF NRC INFORMATION NOTICES AND REGULATORY 

ISSUE SUMMARIES PERTAINING TO PART 36 IRRADIATORS ..... A–1

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

APPENDIX C SUGGESTED FORMAT FOR PROVIDING INFORMATION

REQUESTED IN ITEMS 5 THROUGH 11 OF 

NUCLEAR REGULATORY COMMISSION FORM 313....................... C–1

APPENDIX D IRRADIATION OF EXPLOSIVE MATERIALS OR GREATER 

THAN SMALL QUANTITIES OF FLAMMABLE MATERIALS............ D–1

APPENDIX E TRAINING FOR RADIATION SAFETY OFFICERS AND 

IRRADIATOR OPERATORS ...............................................................E–1

APPENDIX F TYPICAL DUTIES AND RESPONSIBILITIES OF THE 

RADIATION SAFETY OFFICER..........................................................F–1
ix

APPENDIX G INFORMATION NEEDED TO SUPPORT APPLICANT’S 

REQUEST TO PERFORM NONROUTINE OPERATIONS ................. G–1

APPENDIX H CONSTRUCTION MONITORING AND 

ACCEPTANCE TESTING ................................................................... H–1

APPENDIX I SUGGESTED AUDIT CHECKLIST FOR 

10 CFR PART 36 IRRADIATORS.........................................................I–1

APPENDIX J MODEL RADIATION SURVEY INSTRUMENT 

CALIBRATION PROGRAM .................................................................J–1

APPENDIX K GUIDANCE FOR DEMONSTRATING THAT UNMONITORED 

INDIVIDUALS ARE NOT LIKELY TO EXCEED 10 PERCENT 

OF THE ALLOWABLE OCCUPATIONAL DOSE LIMITS .................. K–1

APPENDIX L GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL 

MEMBERS OF THE PUBLIC WILL NOT RECEIVE DOSES

EXCEEDING THE ALLOWABLE LIMITS............................................L–1

APPENDIX M MODEL LEAK TEST PROGRAM FOR DRY-SOURCE-STORAGE 

IRRADIATOR SEALED SOURCES....................................................M–1

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

APPENDIX O EXEMPTIONS FOR TELETHERAPY UNITS CONVERTED TO 

NONHUMAN USE...............................................................................O–1

APPENDIX P COMMENCEMENT OF CONSTRUCTION AT EXISTING AND

PROPOSED BYPRODUCT (INCLUDING IRRADIATORS), 

SOURCE, AND SPECIAL NUCLEAR MATERIAL FACILITIES ..........P–1

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

APPENDIX R CHECKLIST FOR REQUEST TO WITHHOLD PROPRIETORY 

INFORMATION FROM PUBLIC DISCLOSURE 

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

xi

FIGURES

Figure Page

1-1 Dry Source-Storage Irradiator (ANSI Category II Irradiator)..........................................1-2

1-2 Teletherapy Unit Converted to Nonhuman Use (ANSI Category II Irradiator)................1-2

1-3 Underwater Irradiator (ANSI Category III Irradiator)......................................................1-3

1-4 Commercial Wet-Source-Storage Irradiator (ANSI Category IV Irradiator)....................1-3

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

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

8-2 Records Important to Decommissioning .......................................................................8-7

8-3 Typical Duties and Responsibilities of RSOs ..............................................................8-11

8-4 General Description of Facility....................................................................................8-21

8-5 Radiation Detection Instruments.................................................................................8-38

8-6 Material Receipt and Accountability............................................................................8-41

8-7 Annual Dose Limits for Adult Radiation Workers ........................................................8-44

8-8 Proper Handling of an Incident ...................................................................................8-53

8-9 Leak Testing...............................................................................................................8-61

H–1 Construction Monitoring and Acceptance Testing....................................................... H–1

TABLES

Table Page

1-1. Characteristics of Commonly Authorized Irradiators .....................................................1-1

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

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

8-1 Minimum Inventory Quantity Requiring Financial Assurance ........................................8-6

8-2 Requirements for Radiation Monitors .........................................................................8-37

8-3 Elements of Accountability Procedure ........................................................................8-41

8-4 Receipt, Transfer, and Disposal Record Maintenance................................................8-42

8-5 Requirements for Occupational Dosimetry .................................................................8-44

8-6 Radiation Limits Specified in 10 CFR 36.25................................................................8-46

8-7 Operating Procedures ................................................................................................8-48

8-8 Typical NRC Incident Notifications Required for Irradiator Licensees .........................8-54

H–1 Construction Monitoring and Acceptance Testing....................................................... H–1

L–1 Information Known About Dose at the Shield of the Irradiator......................................L–3

L–2 Calculational Method, Part 1: Hourly and Annual Dose Received From Irradiator ......L–3

L–3 Calculational Method, Part 2: Annual Dose Received From a 10 CFR Part 36

Irradiator......................................................................................................................L–4

xiii

ACKNOWLEDGMENTS

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

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

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

Regulatory Commission and all of the States that provided comments and technical information

that assisted in the development of this report.

The working group also thanks Lisa Dimmick, 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

Casey, Colleen C.

Grumbles, Anine

Lee, Willie

Ragland, Randolph

Torres, Roberto J.

xv

ABBREVIATIONS

ACI American Concrete Institute

AEA Atomic Energy Act

ALARA as low as is reasonably achievable

ANSI American National Standards Institute

bkg background

Bq becquerel

C Celsius

CFR Code of Federal Regulations

C/kg coulomb per kilogram

cm centimeter

Co-60 Cobalt-60

cpm counts per minute

Cs-137 Cesium-137

DOT U.S. Department of Transportation

F Fahrenheit

FDA U.S. Food and Drug Administration

ft foot

GBq gigabecquerel

G-M Geiger-Mueller

GPO Government Printing Office

hr hour

IN information notice

kg kilogram

m meter

mR milliroentgen

mrem millirem

mSv millisievert

N/A not applicable

NaI(Tl) sodium iodide (thallium-activated)

NCRP National Council on Radiation Protection and Measurements

NFPA National Fire Protection Association

NMSS Office of Nuclear Material Safety and Safeguards

NRC U.S. Nuclear Regulatory Commission

NSTS National Source Tracking System

NSTTR National Source Tracking Transaction Report

NVLAP National Voluntary Laboratory Accreditation Program

OMB Office of Management and Budget

ORNL Oak Ridge National Laboratory

OSHA Occupational Safety and Health Administration

OSLD optically stimulated luminescence dosimeters

PII Personally Identifiable Information

QA quality assurance

RG regulatory guide

RQ reportable quantities

RSO radiation safety officer

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

International d’unites)

SSD sealed source and device

std standard
xvi

Sv sievert

TI transportation index

TLD thermoluminescent dosimeter

USDA U.S. Department of Agriculture

wk week

yr year
1-1

1 PURPOSE OF REPORT

This report provides guidance to an applicant applying for an irradiator license under Title 10 of 

the Code of Federal Regulations (10 CFR) Part 36, “Licenses and Radiation Safety 

Requirements for Irradiators,”1 and it provides the U.S. Nuclear Regulatory Commission (NRC) 

staff with criteria for evaluating such applications. This NUREG is not intended to address the 

research and development or the commercial aspects of manufacturing, distributing, and 

servicing of 10 CFR Part 36 irradiators and their associated sources. Within this NUREG, the 

phrases or terms, “10 CFR Part 36 irradiators,” “irradiators,” or “irradiators subject to the 

requirements of 10 CFR Part 36” are used interchangeably. As defined in 10 CFR Part 36, a 

“pool irradiator” means any irradiator at which the sources are stored or used in a pool of water

including panoramic wet-source-storage irradiators and underwater irradiators.

This report addresses the variety of radiation safety issues associated with irradiators of various 

designs whose dose rates exceed 5 Gray [500 rads] per hour at 1 meter from the radioactive 

sealed sources in air or in water, as applicable to the irradiator’s design. Table 1-1 describes 

the characteristics of commonly authorized irradiators. Figures 1-1, 1-2, 1-3, and 1-4 illustrate 

several irradiators. Because of differences in design, manufacturers provide appropriate written 

instructions and recommendations for proper operation and maintenance.

Table 1-1. Characteristics of Commonly Authorized Irradiators

Irradiator Type

Panoramic drysource-storage 

(ANSI N43.12 

Category II 

irradiators)

Panoramic wetsource-storage 

(ANSI N43.10 

Category IV 

irradiators)

Underwater (ANSI 

N43.15 Category III 

irradiators)

Sources stored in pool and 

removed to irradiate 

package or product

✔

Sources stored in pool and 

package or product lowered 

into pool to be irradiated

✔

Dry source storage and 

in-air irradiation of package 

or product

✔

Teletherapy unit converted 

to nonhuman use ✔

 

1Self-shielded irradiators (American National Standards Institute (ANSI) Category I irradiators) are not subject to the 

requirements of 10 CFR Part 36 and are discussed in NUREG–1556, Vol. 5, “Consolidated Guidance About Materials

Licenses: Program-Specific Guidance About Self-Shielded Irradiators.”
1-2 

Figure 1-1. Dry Source-Storage Irradiator (ANSI Category II Irradiator)

The sealed sources are stored in a dry storage container constructed of solid 

materials. The sources are fully shielded when not in use. The sources are 

raised into the air to irradiate a product that may be moved into the 

irradiation room.

 

Figure 1-2. Teletherapy Unit Converted to Nonhuman Use 

(ANSI Category II Irradiator)

A teletherapy unit used for research is an example of a panoramic dry 

source-storage irradiator
1-3

Figure 1-3. Underwater Irradiator (ANSI Category III Irradiator)

The sealed sources remain in the water at all times. The product to be 

irradiated is placed in a water-tight container and lowered into the water.

Figure 1-4. Commercial Wet-Source-Storage Irradiator (ANSI Category IV Irradiator)

The sealed sources are stored in water and raised into the air to irradiate a 

product that may be moved into the irradiation room on a conveyor system. 

This is an example of a panoramic wet source-storage irradiator.
1-4

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

complete NRC Form 313, “Application for Materials License” (see Appendix B), for the use of 

sealed sources in 10 CFR Part 36 irradiators. The Office of Management and Budget (OMB) 

has approved the information collection requirements in 10 CFR Part 30, “Rules of General 

Applicability to Domestic Licensing of Byproduct Material,” 10 CFR Part 36, and NRC Form 313 

under OMB Clearance Nos. 3150-0017, 3150-0158, 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 or responses to meet NRC 

requirements, offers the option of an alternative reply, or indicates that no response is 

needed on that topic during the licensing process.

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

Form 313. Appendix A includes a list of Information Notices and Regulatory Issue Summaries 

pertaining to Part 36 irradiators.

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

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

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

convenience and streamlined handling of 10 CFR Part 36 irradiator applications, Appendix C, 

“Suggested Format for Providing Information Requested in Items 5 through 11 of the 

U.S. Nuclear Regulatory Commission Form 313,” may be used to provide 

supporting information.

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

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

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

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

These are used because 10 CFR Part 20 sets dose limits in terms of rem (Sv), rather than rad

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

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

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

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

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

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

alpha particles and neutrons.
2-1 

2 AGREEMENT STATES

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

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

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

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

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

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

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

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

regulatory authority.

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

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

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

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

recognized Indian Tribes.2

 

 

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. 
2-2

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

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

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

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

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

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

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

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

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

regulatory authority.

Table 2-1. Who Regulates the Activity?

Applicant and Proposed Location of Work Regulatory Agency

Federal agency regardless of location (except that the 

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

prime contractors are exempt from licensing in accordance with 

10 CFR 30.12, “Persons using byproduct material under certain 

U.S. Department of Energy and U.S. Nuclear Regulatory Commission 

contracts”.)

NRC

Non-Federal entity in non-Agreement State, District of Columbia, 

U.S. territory or possession, or in offshore Federal waters NRC

Federally recognized Indian Tribe or Tribal member on Indian 

Tribal land NRC

Non-Federal entity on federally recognized Indian Tribal land NRC3

Federally recognized Indian Tribe or Tribal member outside of Indian 

Tribal land in Agreement State. Agreement State

Non-Federal entity in Agreement State Agreement State4

 

3

The NRC can exercise jurisdiction as the regulatory authority on Tribal land of a federally recognized Indian Tribe. 

Section 274b. agreements do not give States the authority to regulate nuclear material in these areas. However, 

there may be States that exercise regulatory authority over these areas based on treaties or agreements with specific 

tribes. Companies owned or operated by federally recognized Indian Tribe members or non-Indians that wish to 

possess or use licensed material on Tribal lands should contact the appropriate NRC regional office to determine the 

jurisdictional status of the Tribal lands and identify the appropriate regulatory agency for licensing and reciprocity.

4Section 274m. of the Atomic Energy Act (AEA) withholds to the NRC regulatory authority over radioactive materials 

covered under the Section 274b. agreements when the activity can affect the Commission’s authority to protect the 

common defense and security, to protect restricted data, or guard against the loss or diversion of special nuclear 

material. (This is an uncommon situation that NRC usually evaluates on a case-by-case basis.) Individuals or 

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

status for specific AEA radioactive materials they intend to possess or use.
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 on the NMSS public Web site at

https://scp.nrc.gov. A request for the list can also be made to an NRC regional office.

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3 MANAGEMENT RESPONSIBILITY

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

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

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

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

and compliance.

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

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

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

3.1 Commitments and Responsibilities

Pursuant to Title 10 of the Code of Federal Regulations (10 CFR) 30.32(c), each application 

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

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

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

may ask for additional assurances that the individual who signed the application is duly 

authorized to act for and on behalf of the applicant or licensee. The signature on an application 

acknowledges the applicant’s or licensee’s commitments and responsibilities for the following:

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

with regulations

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

to the NRC (10 CFR 30.9, “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 and emergency procedures, and NRC license conditions

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

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

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

is maintained

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

with regulations

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

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

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

and responsibilities

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

• prevention of discrimination of employees engaged in protected activities and 

commitment to provide information to employees about employee protection provisions

(10 CFR 30.7, “Employee protection”)

• commitment to provide information to employees about deliberate misconduct provisions 

(10 CFR 30.10, “Deliberate misconduct”)

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

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

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

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

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 under “Document Collections,” at https://www.nrc.gov/reading-rm.html.

3.2 Safety Culture

Individuals and organizations performing regulated activities are expected to establish and 

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

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

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

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

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

subject to NRC authority.

“Nuclear safety culture” is defined in 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.
3-3

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

performance of individuals and organizations to determine compliance with requirements and 

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

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

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

programs. One of the critical safety components for large irradiator installations are safety 

interlocks. Safety interlock failures, and the intentional bypass of safety interlocks, have often

stemmed from a culture in which there is complacency, inattention to detail, lack of 

management oversight, and deficient training. This has led to injury and in some cases proven 

fatal to irradiator workers in other countries. The need to be personally accountable for an 

individual’s safety may correspond with the safety culture trait specified in Table 3-1 as 

“Personal Accountability” (all individuals take personal responsibility for safety).

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

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

https://www.nrc.gov/about-nrc/safety-culture.html.

Table 3-1. Traits of a Positive Safety Culture

Leadership Safety Values

and Actions

Problem Identification and

Resolution Personal Accountability

Leaders demonstrate a 

commitment to safety in their 

decisions and behaviors.

Issues with a potential 

impact on safety are 

promptly identified, fully 

evaluated, and promptly 

addressed and corrected 

commensurate with their 

significance.

All individuals take personal 

responsibility for safety.

Work Processes Continuous Learning

Environment for Raising 

Concerns

The process of planning and 

controlling work activities is 

implemented so that safety 

is maintained.

Opportunities to learn about 

ways to ensure safety are 

sought out and implemented.

A safety-conscious work 

environment is maintained 

where personnel feel free to 

raise safety concerns without 

fear of retaliation, 

intimidation, harassment, or 

discrimination.

Effective Safety 

Communications

Respectful Work 

Environment Questioning Attitude

Communications maintain a 

focus on safety.

Trust and respect permeate 

the organization.

Individuals avoid 

complacency and 

continuously challenge 

existing conditions and 

activities in order to identify 

discrepancies that might 

result in error or 

inappropriate action.

4-1

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 Part 36 irradiators. 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 parts can be found under the “Basic References” link at the

U.S. Nuclear Regulatory Commission’s (NRC’s) online library at https://www.nrc.gov/readingrm.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 32 “Specific Domestic Licenses to Manufacture or Transfer Certain Items

Containing Byproduct Material”

10 CFR Part 36 “Licenses and Radiation Safety Requirements for Irradiators”

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

Radioactive Material”

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

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

Regulatory Services Under the Atomic Energy Act of 1954, as Amended”

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

Materials Licenses, Including Holders of Certificates of Compliance, 

Registrations, and Quality Assurance Program Approvals and 

Government Agencies Licensed by the NRC”

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

Customer Contact Center toll free at 866-512-1800, in Washington, DC, 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).” 
4-2

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

Federal Register.
5-1

5 HOW TO FILE

5.1 Application Preparation

Applicants for a materials license should do the following:

• Use the most recent guidance in preparing an application.

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

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

experience, and the 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 C of this NUREG, as 

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

application or the topic to which it refers.

• Avoid submitting proprietary information and personally identifiable information. If 

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

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

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

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

5.2 Where to File

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

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

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

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

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

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

to Region I.

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

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

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

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

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

States,” for additional information.
5-2

5.3 Paper Applications

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

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

applicants should do the following:

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

document scanner.

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

Use 11-point or larger font.

Avoid stylized characters, such as script or italics.

Ensure that the print is clear and sharp.

Ensure that there is high contrast between the ink and paper (black ink on white paper is best).

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

required by 10 CFR 30.32(c) (see Section 8.13, “Certification”).

5.4 Electronic Applications

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

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

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

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

signatures, and the treatment of nonpublic information.
6-1

6 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION

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

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

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

https://www.nrc.gov/.

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

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

should be marked as indicated in the list that follows, in accordance with Title10 of the Code of 

Federal Regulations (CFR) 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 proprietary information to the public or 

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

checklist for requests for withholding proprietary information from public disclosure.

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

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

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

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

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

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

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

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

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

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

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

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

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

locations of radioactive material at licensed facilities and associated security measures 

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

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

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

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

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

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

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

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

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

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

Summaries” 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 intra-agency memoranda or letters that would not be available by law to a 

party other than an agency in litigation with NRC

• certain records or information compiled for law enforcement purposes

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

concerning wells

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

clearly unwarranted invasion of personal privacy

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

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

regulation is available electronically on the NRC Web site 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 as outlined in 10 CFR 2.390), the applicant will be notified that additional information 

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

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

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

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

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

proprietary status of the information.

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

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

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

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

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

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

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

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

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

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

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

have signed the appropriate agreements for handling proprietary information.

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

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

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

that NRC may have cause to review this determination in the future (e.g., if the scope of a 

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

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

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

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

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

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

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

such information from public disclosure.

7-1

7 APPLICATION AND LICENSE FEES

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

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

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

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

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

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

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

disposition of an application or the withdrawal of an application.

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

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

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

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

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

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

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

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

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

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

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

8-1

8 CONTENTS OF AN APPLICATION

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

(NRC) Form 313 (Appendix B 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, “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.

Applicants for licenses are required by 10 CFR 20.1406, “Minimization of contamination,” to 

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

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

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

As with ALARA considerations, applicants should address these concerns for all aspects of 

their programs.

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

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

material not in storage.”

Refer to Appendix P of this NUREG for guidance regarding the definition of construction and the 

consideration of activities that can be performed by materials license applicants and potential 

applicants and licensees before the NRC has concluded its environmental review of the 

proposed licensing action, if required. The issuance of an irradiator license does not require the 

NRC to develop an environmental assessment or an environmental impact statement, in 

accordance with the National Environmental Policy Act and 10 CFR 51.22(c)(14)(vii). 

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

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

8.1 Item 1: License Action Type

Item 1 of NRC Form 313 states the following:

This is an application for (check appropriate item):
8-2

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 site visit might be required 

prior to issuance of the license. Also note that an on-site security review, when required, will be 

conducted prior to issuance of the license. Applicants and licensees are required to implement 

the 10 CFR 37.21(a) and 37.41(a) security requirements before taking possession of an 

aggregated Category 1 or Category 2 quantity of radioactive material. Prior to issuing a license 

or an amendment authorizing aggregated Category 1 or 2 quantities of radioactive material, 

license reviewers should ensure that applicants or licensees have a thorough understanding of 

the Part 37 requirements, and are prepared, as evidenced through on-site security review and 

discussions with applicants or licensees, to implement the security requirements prior to the 

applicant or licensee taking possession of Category 1 or Category 2 quantities of 

radioactive material.

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

8.2 Item 2: Name and Mailing Address of Applicant

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

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

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

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

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

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

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

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

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

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

Bankruptcy Proceedings”). 

8.2.1 Notification of Bankruptcy Proceedings

Regulation: 10 CFR 30.34(h)

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 
8-3

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 may request that the U.S. Department of Justice (DOJ) 

represent the NRC’s interests in the bankruptcy proceeding.

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

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

involuntary petition for bankruptcy by or against the licensee.

Reference: See NUREG–1556, Volume 15, Revision 1, “Consolidated Guidance About 

Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving 

Byproduct, Source, or Special Nuclear Materials Licenses.”

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

or Possessed

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

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

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

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

applicants are encouraged to provide global positioning system coordinates, as appropriate. 

Figure 8-1. Location of Use or Possession

An acceptable location of use or possession specifies street address, city, 

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

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

address or location not already listed on the license.

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

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

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 8.5.2, “Financial Assurance and Recordkeeping for 

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

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

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

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

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

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

around the licensee’s facilities.

8.4 Item 4: Person to be Contacted About This Application

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

number where the individual may be contacted. 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. 

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

be submitted on separate sheets of paper. Applicants may use Appendix C of this NUREG 

for this purpose and should note that using the suggested wording of responses and 

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

8.5 Item 5: Radioactive Material

8.5.1 Sealed Sources and Devices

Regulation: 10 CFR 20.2207, 10 CFR 30.32(g), 10 CFR 30.33(a)(2), 10 CFR 32.210, 

10 CFR 36.21, 10 CFR Part 37

Criteria: Applicants must provide the manufacturer’s (or distributor’s) name and model number 

for each irradiator. Applicants must provide the manufacturer’s (or distributor’s) name and 

model number for each sealed source being requested. Licensees will only be authorized for 

irradiators or sealed sources containing byproduct material meeting NRC performance 

requirements and specifically approved or registered by the NRC or an Agreement State. In 

addition, applicants should identify any depleted uranium that is used as shielding material in 

teletherapy units converted to nonhuman use and other irradiators that may contain depleted 

uranium. Licensees must also protect Category 1 and Category 2 quantities of radioactive 

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

Discussion: 10 CFR 36.21, “Performance criteria for sealed sources,” and 10 CFR 32.210, 

“Registration of product information,” list criteria for sealed sources used in irradiators. 
8-5

Normally, tests used to demonstrate that the criteria can be met are conducted by the source 

manufacturer (or distributor), not the applicant. The manufacturer (or distributor) then applies to 

the NRC or an Agreement State agency for approval for use in irradiators. The safety 

evaluation is documented in a sealed source and device (SSD) registration certificate. 

Therefore, if the NRC or an Agreement State approves sealed sources for use in the requested 

irradiator, the applicant need only note the manufacturer (or distributor’s) name and model 

number of the sources in its license application to demonstrate that the requirements are met. If 

the manufacturer and/or distributor are no longer in service, a copy of the SSD registration 

certificate may be requested from the NRC or the issuing Agreement State.

If an applicant wishes to install sealed sources that are not currently listed on the license, the 

licensee must request a license amendment, and the NRC must approve the amendment prior 

to source installation. New sources must meet the requirements of 10 CFR 36.21 and be 

approved for use in the type of irradiator possessed by the licensee. 

Licensees may not make any changes to the sealed sources 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. A custom registration review also may be 

required. This would increase the time needed to process a licensing action. Sealed sources 

used in irradiators are usually at or above Category 2 quantities. Applicant and licensee 

information on manufacturers, model numbers, and possession limits is sensitive and should be 

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

Category 1 and Category 2 sources regulated by the NRC and Agreement States must be 

tracked in the National Source Tracking System (NSTS) in accordance with 10 CFR 20.2207, 

“Reports of Transactions Involving Nationally Tracked Sources.” Refer to Item 8.10.3, “Material 

Receipt and Accountability,” for more information.

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 of Part 37. See Section 8.10.13, “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 the manufacturer (or distributor) and model number of each sealed source to be 

used in each irradiator. For each source model, identify the radionuclide and the 

maximum activity per source.

• Identify the manufacturer (or distributor) and model number of each irradiator to be 

used. For each irradiator, identify the radionuclide, the source model number, maximum 

activity per source, and total possession limit being requested. If applicable, identify any 

depleted uranium that is used as shielding material (e.g., teletherapy units converted to 

nonhuman use), and specify the total amount in kilograms. 

• Confirm that the proposed sealed source or sealed source/irradiator combination 

(Category II dry-source-storage) is registered with the NRC or an Agreement State and 

will be possessed and used in accordance with the conditions specified in the 

registration certificate. Obtain a copy of the SSD certificate from the manufacturer or 

distributor and provide the SSD registry number with the application.
8-6

Mark the section related to possession of sealed sources and devices with manufacturers, 

model numbers, and possession limits as follows: “Security-Related Information—Withhold 

Under 10 CFR 2.390.”

8.5.2 Financial Assurance and Recordkeeping for Decommissioning

Regulations: 10 CFR 30.34(b), 10 CFR 30.35, 10 CFR 30.51(f), 10 CFR 36.81

Criteria: Irradiator licensees authorized to possess sealed sources containing byproduct 

material with a half-life (T1/2) greater than 120 days and in excess of the limits specified in 

10 CFR 30.35, “Financial assurance and recordkeeping for decommissioning,” must provide 

evidence of financial assurance for decommissioning. See Table 8-1, “Minimum Inventory 

Quantity Requiring Financial Assurance.”

Pursuant to 10 CFR 30.35(g) licensees must maintain, in an identified location, 

decommissioning records related to structures and equipment where devices are used or 

stored, as well as records related to leaking sources. Also pursuant to 10 CFR 30.35(g), 

licensees must transfer records important to decommissioning (see Figure 8-2) to the new 

proposed licensee before licensed activities are transferred or assigned according to 

10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 30.51(f), prior to license termination, each 

licensee must forward the records required by 10 CFR 30.35(g) to the appropriate NRC 

regional office.

Discussion: The requirements for financial assurance are specific to the types and quantities 

of byproduct material authorized on a license. Most irradiator applicants and licensees need to 

comply with the financial assurance requirements because the thresholds for sealed sources 

containing byproduct material are 3.7 × 105 gigabecquerels (GBq) [10,000 curies (Ci)] of 

cobalt-60 and 3.7 × 106 GBq [100,000 Ci] of cesium-137. Applicants and licensees desiring to 

possess sources exceeding the threshold amounts should submit evidence of financial 

assurance. Licensees may follow the guidance provided in NUREG–1757, Volume 3, 

Revision 1, “Consolidated Decommissioning Guidance: Financial Assurance, Recordkeeping,

and Timeliness.”

The regulations in 10 CFR 30.35(g) also require that licensees maintain records important to 

decommissioning in identified locations. All licensees must maintain records of structures and 

equipment where irradiator sources are used or stored. As-built drawings showing 

modifications to structures and equipment fulfill this requirement. If drawings are not available, 

licensees may substitute appropriate records (e.g., a sketch of the room or building or a 

narrative description of the area) concerning the areas and locations. In addition, irradiator

licensees that have experienced unusual occurrences (e.g., leaking sources or other incidents 

that involve spread of contamination) must also maintain records about contamination that 

remains after cleanup or contamination that may have spread to inaccessible areas. Leak test 

results of sealed sources, records of radiation monitors on a pool water recirculation system, 

and records of analysis of pool water samples are part of the decommissioning records. 

Table 8-1. Minimum Inventory Quantity Requiring Financial Assurance

Radionuclide

(sealed sources) Activity in Gigabecquerels Activity in Curies

Co-60 3.7 × 105 10,000

Cs-137 3.7 × 106 100,000
8-7

Figure 8-2. Records Important to Decommissioning

All irradiator licensees must maintain records important to decommissioning, 

regardless of whether they need financial assurance for decommissioning.

Response from Applicants: 

Applicant must provide a statement that: “Pursuant to 10 CFR 30.35(g), we will maintain

records important to decommissioning and transfer these records to an NRC or Agreement 

State license, before licensed activities are transferred or assigned, in accordance 

with10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 30.51(f), prior to license termination, 

we will forward the records required by 10 CFR 30.35(g) to the appropriate NRC regional office

before the license is terminated.”

AND

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

guidance of NUREG–1757, Volume 3, Revision 1, ‘Consolidated Decommissioning Guidance: 

Financial Assurance, Recordkeeping and Timeliness.’”

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

Financial Assurance, Recordkeeping, and Timeliness”

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

Regulation: 10 CFR 30.33(a)(1), 10 CFR 36.69, 10 CFR 51.22(c)(14)

Criteria: 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 in accordance with the manufacturer’s recommendations for use,

as specified in an approved SSD registration certificate. 
8-8

The issuance of an irradiator license does not require the NRC to develop an environmental 

assessment or an environmental impact statement in accordance with the National 

Environmental Policy Act and 10 CFR 51.22(c)(14)(vii). 

Discussion: Requests to use sealed sources in irradiators for purposes not listed in the SSD 

registration certificate will be reviewed on a case-by-case basis. Examples might include 

greater than small quantities of flammable materials with a flash point below 60° C [140° F], 

irradiation of explosive material, or cryogenic material.

1

If an applicant wants to irradiate greater than small quantities of flammable materials with a 

flash point below 60° C [140° F], see Appendix D of this NUREG. In addition, irradiation of 

explosives is generally prohibited; however, if an applicant wants to request irradiation of 

explosives, see Appendix D.

Applicants need to submit sufficient information to demonstrate that the proposed use will not 

compromise the integrity of the source or source shielding, or other radiation safety-critical 

components of the device. The NRC will evaluate the radiation safety program for each type 

and use of sealed source in each irradiator requested.

Irradiation of food and certain other products intended for commercial distribution to the public 

also is subject to the regulations of the U.S. Food and Drug Administration (FDA) and the 

U.S. Department of Agriculture (USDA). Contact these agencies for further information. An 

NRC licensee also must comply with applicable FDA or USDA regulations.

Response from Applicant: Provide either of the following:

• A specific description of use for each type of irradiator requested (e.g., for use in 

irradiation of products or food). There will be no irradiation of explosives and no 

irradiation of more than small quantities of flammable materials with a flash point below 

60° C [140° F] without specific written authorization from the NRC.

OR

• If the irradiator will be used for purposes other than irradiation of food or products for 

human consumption or research purposes, a description of these purposes and safety 

analyses (and procedures) should be provided to support safe use.

FOR IRRADIATION OF GREATER THAN SMALL QUANTITIES OF FLAMMABLE 

MATERIALS (evaluated on a case-by-case basis). The following portions of this 

response are N/A if not needed.

If an applicant is applying for authorization to irradiate more than a small quantity of flammable 

material, the application should include all of the following information:

• name of the flammable material that has a flash point below 60°C [140°F] and its 

flash point

 

1Under certain conditions, particular irradiated cryogenic material can explode.
8-9

• its flammable limit as percent by volume in air

• its specific gravity as a liquid

• its vapor density relative to that of air

• maximum quantity to be in the direct radiation beam in the radiation room at any 

one time

• description of the packaging for the product

In addition, the application should

EITHER

Describe why a single failure is unlikely to cause immobilization of the product being irradiated 

with the simultaneous inability to return the sources to the shielded position.

OR

Describe why the ventilation system will prevent the concentration of vapor in air from 

exceeding the lower flammable limit in a significant volume of the room if the product is 

immobilized and the sources cannot be returned to the shielded position. If this second 

approach is taken, the applicant should also provide a procedure to return the source to the 

shielded position, and remove the product from the radiation room if the ventilation system fails. 

The procedure should identify the means to detect ventilation system failure.

Notes:

• Allowed uses of irradiators normally include the irradiation of food or products for human

or animal consumption, medical sterilization, or research purposes.

• Unusual uses, including irradiation of explosives and greater than small quantities of 

flammable material, will be evaluated on a case-by-case basis, and the authorized use 

condition will reflect approved uses.

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

8.7.1 Radiation Safety Officer (RSO) Training and Experience

Regulations: 10 CFR 30.33(a)(3), 10 CFR 36.13(d), 

Criteria: RSOs are responsible for ensuring that the licensee’s radiation safety program is 

implemented in accordance with approved procedures and must have adequate training 

and experience. 

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

RSO is key to overseeing and ensuring safe operation of the licensee’s radiation protection

program. The RSO must have adequate training to understand the hazards associated with 

radioactive material and be familiar with all applicable regulatory requirements. The RSO 

should have independent authority to stop operations that he or she considers unsafe. He or 
8-10

she should have sufficient time and commitment from management to fulfill his or her duties and 

responsibilities to ensure that radioactive materials are used in a safe and secure manner. 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. The named individual should agree, in writing, to 

assume the duties of RSO. Appendix F of this NUREG contains a model RSO delegation of 

authority. Figure 8-3 and Appendix F of this NUREG illustrate typical RSO duties. For 

licensees possessing an aggregated Category 1 or Category 2 quantity of radioactive material, 

duties may also include participating in the development and implementation of a security 

program for radioactive material in accordance with 10 CFR Part 37. A “Category 1 quantity of 

radioactive material” and a “Category 2 quantity of radioactive material” are defined terms in 

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

Appendix A to 10 CFR Part 37.

The RSO may delegate certain day-to-day tasks of the radiation protection program to other 

responsible individuals, sometimes referred to as “alternate RSOs” or “site RSOs.” For 

example, a licensee with multiple permanent locations of use or use at temporary jobsites may 

appoint “site RSOs,” who assist the RSO and are responsible for the day-to-day activities at 

these locations. Licensees may also appoint “alternate RSOs” who may “step in” as an 

emergency contact when the RSO is unavailable. Such “alternate RSOs” or “site RSOs” do not 

need to meet all RSO qualifications; however, they should be qualified, experienced authorized 

users who have adequate knowledge of the activities to which they are assigned. These 

individuals should have the same management support and decision-making authority as the 

RSO that is necessary to accomplish the tasks to which they have been assigned. Please note 

that only the primary RSO is named on an NRC license.

In accordance with 10 CFR 36.13(d), the applicant must provide the NRC with a description of 

the organizational structure for managing the irradiator, specifically the radiation safety 

responsibilities and authorities of the RSO and those management personnel who have 

important radiation safety responsibilities or authorities. The applicant must specify who within 

the management structure has the authority to stop unsafe operations. The applicant must also 

describe the training and experience required for the RSO.

To be considered eligible for the RSO position, an individual should complete a radiation safety 

course. Training should include approximately 40 hours covering the following topics:

• radioactivity and radioactive decay

• interactions of radiation with matter

• biological effects of radiation

• radiation detection and measurement using radiation-detection instruments and 

personnel dosimeters

• basic radiation protection principles and good safety practices (including time, distance, 

and shielding)

• radiation protection regulations and regulatory requirements
8-11

The course should include a written test or evaluation of the individual’s comprehension of these 

topics. See Appendix E of this NUREG for a detailed description of RSO training courses and 

exam guidance.

In addition to the above general course, if the RSO was previously an RSO at a similar licensee 

site or was trained as an irradiator operator but has not had experience working at an irradiator, 

he or she should have the equivalent of at least 40 hours in self-study or directed study on 

information directly applicable to radiation safety at irradiators. This should include applicable 

regulations (10 CFR Part 20, “Standards for Protection Against Radiation” and 10 CFR Part 36, 

and reports or studies describing case histories of accidents or problems at irradiators

(see Appendix F of this NUREG). The license application should list the documents studied or 

to be studied in the description of the training of the proposed RSO and should describe how 

the applicant will evaluate the individual’s comprehension of the information studied.

The RSO should have at least 3 months (full-time equivalent) of experience at the 

applicant’s irradiator or at another irradiator of a similar type. The 3 months of experience 

may include pre-operational involvement, such as acceptance testing, while the irradiator is 

being constructed.

However, to allow flexibility, the NRC will determine the adequacy of the RSO’s training and 

experience on a case-by-case basis, looking at his or her actual qualifications, and drawing on 

the NRC staff’s experience in reviewing such qualifications.

Figure 8-3. Typical Duties and Responsibilities of RSOs
8-12

Note: The NRC will consider individuals with alternative training and experience as RSOs. For 

example, a person certified in health physics or industrial hygiene with previous experience in 

managing a radiation safety program of comparable size and scope could be considered as an 

individual case. The qualifications, training, and experience required of the RSO may vary,

depending upon the complexity of the applicant’s operations and number of irradiator personnel.

Response from Applicant: Provide the following:

• The name of the proposed RSO, including delegation of authority, who will be 

responsible for ensuring that the licensee’s radiation safety program is implemented in 

accordance with approved procedures.

AND

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

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

position, demonstrating day-to-day oversight and coordination with management in 

radiation safety activities.

AND

• The specific training and experience of the RSO. Include the specific dates of 

certification or training, or both, in radiation safety.

• Documentation showing the RSO’s training and experience specific to the irradiator that 

the applicant intends to use.

• Documentation to show that the RSO has obtained training in the regulatory 

requirements applicable to Part 36 irradiators.

OR

• Alternative information demonstrating that the proposed RSO is qualified by training and 

experience (e.g., certification by the American Board of Health Physics, completion of a 

bachelor’s 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).

• Documentation to show that the RSO has obtained training and experience applicable to 

the regulatory requirements of Part 36 irradiators.

Note: It is important to notify the NRC and obtain a license amendment before making changes 

in the designation of the RSO responsible for the radiation safety program.

8.8 Item 8: Individuals Working in or Frequenting Restricted Areas

8.8.1 Initial Training and Experience for Irradiator Operators

Regulations: 10 CFR 19.12, 10 CFR 30.9, 10 CFR 30.33, 10 CFR 36.13(b), 10 CFR 36.23(b),

10 CFR 36.51(a), 10 CFR 36.51(b), 10 CFR 36.51(c), 10 CFR 37.43
8-13

Criteria: Irradiator operators must have adequate training and experience. Successful 

completion of one of the following is evidence of adequate training and experience that will 

enable an individual to operate the irradiator without a supervisor present:

• irradiator manufacturer’s course for operators specific to the irradiator that the applicant 

intends to use and a description of the initial training program for irradiator operators that 

demonstrates compliance with the requirements of 10 CFR 36.51(a), (b), and (c)

OR

• training course as described in Appendix E of this NUREG

The training provided to individuals to qualify them to be irradiator operators must include:

• instruction

• on-the-job or simulator training (i.e., supervised experience)

• means employed by the applicant to test each individual’s understanding of the 

Commission’s regulations and licensing requirements and the irradiator safety, security, 

operating, and emergency procedures

• minimum training and experience of personnel who may provide training

In addition, instruction must be provided to at least one other individual who will be on site 

during operations on how to respond to the access control alarm and to promptly render or 

summon assistance.

Nonroutine operations, including activities such as loading and unloading of sources in an 

irradiator, are typically performed by the source manufacturer or by an NRC or Agreement State 

licensee specifically authorized to perform such activity. Applicants requesting to perform 

nonroutine operations must provide additional training. For more information, see Appendix G

of this NUREG.

Any licensee that possesses an aggregated Category 1 or Category 2 quantity of radioactive 

material (as defined in 10 CFR 37.5) must implement a training program for those individuals 

implementing the security program.

Discussion: Irradiator operators have the responsibility to ensure the proper use and security 

of irradiators containing licensed material. Irradiator operators must receive training and 

instruction and be tested before being permitted to operate an irradiator without a 

supervisor present.

Training should be commensurate with the complexity of the irradiator design and potential 

radiation hazard (e.g., approximately 40 hours of instruction for pool-type panoramic irradiators 

and approximately 20 to 30 hours of instruction for underwater irradiators). Up to 50 percent of 

that instruction may be self-study or reading. The written test should cover the range of topics 

covered in the instruction (See Appendix E of this NUREG).

On-the-job training should be supervised by an experienced operator and should last at least 

1 month on a full-time basis (approximately 160 hours). If an approved operator does not 
8-14

operate the irradiator for more than a year, his or her performance during operation should be 

audited for at least 1 day before he or she is permitted to operate the irradiator independently

receive a safety review regarding the irradiator

The requirements in 10 CFR 36.51(a), (b), and (c) are for an individual to become qualified 

initially as an irradiator operator who is permitted to operate an irradiator without a supervisor 

present. The safety reviews and evaluation requirements of 10 CFR 36.51(d) and (e), however, 

apply to all irradiator operators. Current licensees should conduct safety reviews to discuss 

10 CFR Part 36 regulations and any resulting changes in operating and emergency procedures. 

Licensees also should conduct safety reviews at intervals not to exceed 12 months thereafter. 

Individuals must be trained in the following subjects to become an irradiator operator:

• The fundamentals of radiation safety as they apply to irradiators

— The goal is to provide the individual with the necessary foundation to perform his 

or her task safely and to help the individual worker understand the basis for the 

safety requirements and procedures that will be taught.

• The requirements of 10 CFR Part 19, “Notices, Instructions and Reports to Workers: 

Inspection and Investigations,” and 10 CFR Part 36

— The operator is not expected to be an authority on NRC regulations or to be able 

to determine whether a given procedure is adequate to meet NRC regulations. 

Instead, operators should be instructed on NRC requirements that are directly 

applicable to their responsibilities.

• The operation of the licensee’s irradiator

— The objective is to help the person understand the operating and emergency 

procedures, not to become an engineer.

• Licensee operating and emergency procedures that the individual will be required 

to perform

— This is the most important part of the training because operating the irradiator 

safely depends on following these procedures correctly. The objective is that the 

operator correctly perform his or her assigned tasks. The training does not have 

to include procedures that the individual will not perform.

— Safety and security requirements: The individual should be trained and 

competent in all safety and security procedures.

• Case histories of accidents and problems involving irradiators

— The individual should be taught about situations that could lead to problems 

associated with irradiator operations. Instruction material on accidents or events 

is often difficult to obtain. See Appendix A of this NUREG for a list of NRC 

Information Notices (IN) describing irradiator events.
8-15

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

Category 2 quantity of radioactive material must implement a training program in accordance 

with 10 CFR 37.43, “General security program requirements,” and specifically, must comply 

with 10 CFR 37.43(c), “Training,” to ensure that those individuals who may have a 

responsibility to implement portions of the security program possess and maintain the 

knowledge, skills, and abilities to carry out their assigned duties and responsibilities effectively. 

Additionally, in accordance with 10 CFR 37.43(c)(3), refresher training must be provided at a 

frequency not to exceed 12 months and when significant changes have been made to the 

security program. For additional guidance on implementing 10 CFR Part 37 requirements, 

see NUREG–2155, “Implementation Guidance for 10 CFR Part 37, ‘Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material.’” Additional information 

regarding best practices for protection of risk-significant radioactive material is available in 

NUREG–2166, “Physical Security Best Practices for the Protection of Risk-Significant 

Radioactive Material.”

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

be subject to review and inspection. 

Additional training is required for irradiator operators if they will perform nonroutine operations. 

For more information, see Appendix G of this NUREG.

Response from Applicant: Provide the following:

• The statement: “Before using licensed materials, irradiator operators will have 

successfully completed one of the training courses described in Criteria in section 8.8.1

‘Initial Training and Experience for Irradiator Operators’ in NUREG-1556, Volume 6, 

Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About 10 CFR Part 36 ‘Irradiator Licenses.’”

OR

• A description of the initial training program for irradiator operators that demonstrates

compliance with the requirements of 10 CFR 36.51(a), (b), and (c).

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

8.8.2 Annual Safety Reviews and Performance Evaluations for 

Irradiator Operators

Regulations: 10 CFR 19.12, 10 CFR 30.33, 10 CFR 36.51(d), 10 CFR 36.51(e)

Criteria: Licensees must conduct safety reviews for irradiator operators annually. Licensees 

also must evaluate the safety performance of each irradiator operator annually.

Discussion: Licensees must provide refresher training, called safety reviews, to irradiator 

operators as well as evaluate the safety aspects of each irradiator operator’s performance 

(i.e., performance evaluation).
8-16

Annual Safety Reviews

Safety reviews must include, as appropriate, each of the following areas:

• changes in operating and emergency procedures since the last review

• changes in regulations and license conditions since the last review

• reports on recent accidents, mistakes, or problems that have occurred at 

irradiator facilities

• relevant results of inspections2 of operator safety performance

• relevant results of the facility’s inspection and maintenance checks

• a drill to practice an emergency or abnormal event procedure

Also, each operator must be given a brief written test on the information covered during the 

safety review [See 10 CFR 36.51(d)].

The duration of safety reviews should be commensurate with the complexity of the irradiator’s 

design and potential radiation hazard and changes since the last review (e.g., approximately 

4 hours for panoramic wet-source-storage irradiators and 2 hours for dry-source-storage and 

underwater irradiators). Safety reviews may be conducted at intervals not to exceed 12 months 

or throughout the calendar year on an as-needed basis.

The “drill” referenced in 10 CFR 36.51(d)(6) means actually going through a procedure using 

the actual equipment in as realistic a manner as practical. For example, for a drill on the 

response to a fire alarm, it is not necessary that the alarm actually be enunciated if sounding the 

alarm would be disruptive. Each operator should take an active part in the drill. Individuals who 

must be prepared to respond to alarms required by 10 CFR 36.23(b), 10 CFR 36.23(i), 

10 CFR 36.27(a), 10 CFR 36.29(a), 10 CFR 36.29(b), and 10 CFR 36.59(b), shall be trained 

and tested on how to respond. 

Annual Performance Evaluations

The safety performance of each irradiator operator must be evaluated and reviewed at least 

every 12 months, to ensure that regulations, license conditions, and operating and emergency 

procedures are followed. In addition, the results of the evaluation must be discussed with each 

operator, along with instructions on how to correct any mistakes or deficiencies observed. 

Individuals (e.g., the RSO or trained operators conducting these reviews) must have adequate 

training and experience to direct such evaluations. The applicant should identify these 

individuals by position if the position requires the qualifications, or by name of the 

qualified individual.

 

2The word “inspections” in 10 CFR 36.51(d)(4) means the “evaluations” performed under 10 CFR 36.51(e).
8-17

Response from Applicant: Describe the program for annual safety reviews and performance 

evaluations of irradiator operators that demonstrates compliance with 10 CFR 36.51(d) and (e).

8.8.3 Training for Individuals Who Require Unescorted Access

Regulations: 10 CFR 19.12, 10 CFR 30.9, 10 CFR 30.33, 10 CFR 36.51(f)

Criteria: Individuals who will be permitted unescorted access to the radiation room of the 

irradiator or the area around the pool of an underwater irradiator, but who have not received the 

training required for irradiator operators and the RSO, must be instructed and tested in 

precautions to avoid radiation exposure; procedures listed in 10 CFR 36.53, “Operating and 

Emergency Procedures,” which they must perform or comply with; and their proper response 

to alarms.

Note: 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. Refer to Section 8.10.13, “Security Program” and 

NUREG–2155, “Implementation Guidance for 10 CFR Part 37, ‘Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material,’” for information regarding 

an individual who requires unescorted access to Category 1 or Category 2 quantities of 

radioactive material.

Discussion: According to 10 CFR 19.12, “Instructions to workers,” all individuals who, in the 

course of employment, are likely to receive an occupational dose in excess of 100 millirem 

(mrem) [1 millisievert (mSv)] in a year must receive appropriate instruction on radiation safety. 

However, in some facilities, certain individuals other than irradiator operators may require 

unescorted access to the radiation room of an irradiator. The applicant should identify those 

individuals (e.g., individuals who perform inspection and maintenance checks) and train them 

according to 10 CFR 36.51(f).

Training may include the subjects described in Appendix E of this NUREG. In accordance with 

10 CFR 36.51(f), individuals who will be permitted unescorted access must be instructed and 

tested in any precautions or procedures listed in 10 CFR 36.53. 

Response from Applicant: The applicant’s program for instructing and testing unescorted 

individuals (other than irradiator operators) will be examined during inspections but should not 

be submitted in the license application.

8.8.4 Training for Individuals Who Must be Prepared to Respond to Alarms

Regulations: 10 CFR 19.12, 10 CFR 30.33, 10 CFR 36.23(b), 10 CFR 36.23(i), 

10 CFR 36.27(a), 10 CFR 36.29(a), 10 CFR 36.29(b), 10 CFR 36.51(g), 10 CFR 36.59(b)

Criteria: In accordance with 10 CFR 36.51(g), individuals who must be prepared to respond to 

an activation of an alarm shall be trained and tested on how to respond to such an alarm to 

promptly render or summon assistance following the licensee’s operating and emergency 

procedures. Each individual shall be retested at least once a year. Tests may be oral.
8-18

Discussion: In accordance with 10 CFR 36.51(g), individuals who will respond to any of the 

following alarms shall be trained and tested at least once a year:

• Activation of an access control alarm (visible and audible alarm) indicating the detection 

of a personnel entry to the irradiation room while the sources are exposed.

• Activation of an intrusion alarm (personnel access barrier around the pool to prevent 

access when the irradiator is not attended) to detect unauthorized entry into the pool 

when the personnel access barrier is locked. Activation of the intrusion alarm must alert 

an individual who may not necessarily be onsite. This intrusion alarm system is specific 

to underwater irradiators.

• Activation of heat and smoke detector alarm (audible alarm) indicating the presence of 

a fire.

• Activation of a radiation monitor alarm (audible alarm) in an irradiator with an automatic

product conveyor system indicating the presence of a loose radioactive source that is 

being carried toward the product exit.

• Activation of a radiation monitor alarm (audible alarm and visible indicator) to detect 

abnormal radiation levels that is located at entrances to the personnel access barrier 

around the pool irradiator. This radiation monitor alarm system is specific to underwater 

irradiators that are not in a shielded radiation room. 

• Activation of a radiation monitor alarm on a pool water circulating system in an irradiator 

indicating above-normal radiation levels.

Response from Applicant: The applicant’s program for instructing and testing individuals 

designated to respond to alarms, as applicable, will be examined during inspections but should 

not be submitted in the license application.

8.9 Item 9: Facilities and Equipment

8.9.1 General Description of the Facility and Site

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.13(e), 10 CFR 36.25, 10 CFR 36.33.

10 CFR 36.39, 10 CFR 36.61, 10 CFR Part 37, 10 CFR 37.5, 10 CFR 37.49, 10 CFR 37.53

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

life or property. Facilities and equipment must also provide enhanced physical protection of 

aggregated Category 1 and Category 2 quantities of radioactive material, as defined in 

10 CFR 37.5. The application must include a diagram of the facility that shows the locations of 

all required interlocks and radiation monitors.

According to 10 CFR 36.15, commencement of construction of an irradiator may not occur 

before the licensee or applicant submits both an application and fee to the NRC. Any 

construction activities undertaken before the issuance of a license are entirely at the risk of the 

applicant or licensee. An environmental review by the NRC is not required because irradiators 

are categorically excluded from these reviews by 10 CFR 51.22(c)(14)(vii). For additional 

guidance on what pre-licensing construction activities may be undertaken by the applicant or 

licensee, see Appendix P of this NUREG.
8-19

Discussion: A diagram of the facility must be submitted for review, with enough detail 

designating the location of required interlocks, radiation monitors, alarms and other required 

systems to be used at the facility (e.g., blueprints with interlock and radiation monitor locations 

identified) (see Figure 8-4). In addition, the diagram should include a general layout of the 

entire facility, identifying areas surrounding the irradiator room.

The irradiator must meet the design requirements that are described in 10 CFR 36.39, “Design 

Requirements.” These requirements are summarized below. In addition, the licensee must 

describe the site-specific testing frequency of all required systems, as described in 

10 CFR 36.61, “Inspection and Maintenance.”

For panoramic irradiators:

• shielding design meets generally accepted local building code requirements and to 

ensure that radiation dose rates in unrestricted areas will not exceed 0.02 mSv [2 mrem]

in any one hour at any location 30 centimeters from the exterior of the shielding walls

• effects of heating on shielding walls if the irradiator will use more than 2 × 1017 Bq

[5 million Ci] of licensed material

• foundation design to demonstrate that there is adequate support for the weight of the 

facility shield walls with consideration given to soil characteristics, as verified by a 

qualified engineer

• design of the source rack to ensure that source rack drops due to loss of power will not 

damage the source rack and that source rack drops due to failure of cables (or alternate 

means of support) will not cause loss of integrity of sealed source

• design of the source rack to ensure that the mechanism that moves the source rack

assures that the likelihood of a stuck source is low, and that, if the rack sticks, a means 

exists to free it with minimal risk to personnel

• design and logic diagram for the access control system to ensure that it meets the 

requirements of 10 CFR 36.23(g), “Access control”

• design of the fire detection system such that the number, location, and spacing of smoke 

and heat detectors to ensure that the system is appropriate to detect fires, and that the 

system is protected from mechanical and radiation damage

• design of the fire extinguishing system that provides necessary discharge patterns, 

density, and flow characteristics for complete coverage of the radiation room

• design of the source return mechanism to ensure that the source rack will automatically 

return to the fully shielded position if offsite power is lost for more than 10 seconds

• design of the steel or reinforced concrete radiation shields following appropriate building 

codes to ensure their integrity in the event of an earthquake

• design of the electrical wiring and electrical equipment in the irradiation room to ensure 

minimization of failures caused by prolonged exposure to radiation
8-20

For pool irradiators

• pool design to ensure that pool integrity is strong enough to bear the weight of the pool 

water and shipping cask, to ensure that a dropped cask will not fall on sealed sources 

and that the pipes and metal components are metallurgically compatible with other 

components in the pool

• pool design to ensure a watertight stainless steel liner or a liner metallurgically 

compatible with other components in the pool

• pool design to ensure that there is low likelihood of substantial leakage, have a surface 

designed to facilitate decontamination, and have a method to safely store sources during 

repairs of the pool

• design of pool water intake, outlets, and other means to prevent siphoning of pool water

• design of the pool water handling and purification system to replenish water losses from 

the pool

• design of the visible water level indicator that shows if the pool water level is below 

normal low water levels or above normal high water levels

• design of the water handling and purification system to ensure proper water chemistry 

is maintained

• design of the water handling and purification system to ensure that water leaking from 

the system does not drain to unrestricted areas without being monitored

• design of the radiation monitor system to ensure that the system includes sensitive 

detectors located close to where contamination is likely to occur

• design of the source rack to ensure that there are no crevices on the source or between 

the source and the source holder that would promote corrosion on a critical area of 

the source

For all irradiators

• Design of the location and sensitivity of the radiation monitors to ensure that the product 

conveyor system stops operating before a source on the conveyor would cause a 

radiation overexposure to any person.
8-21

Figure 8-4. General Description of Facility

Diagrams, drawings, sketches, or blueprints of facilities are needed for a clear 

understanding of the facility’s design and its relationship to adjacent properties.

An applicant should provide a schedule for construction activities associated with the irradiator. 

This will allow the NRC to inspect and ensure construction activities meet design requirements 

as described in NRC Manual Chapter 2815, entitled “Construction and Preoperational 

Inspection of Panoramic, Wet-Source-Storage Gamma Irradiators” and Appendix P of this 

NUREG, “Commencement of Construction at Existing and Proposed Byproduct 

(Including Irradiators), Source, and Special Nuclear Material Facilities.”
8-22

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 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 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:

• Describe the irradiator design by including information, drawings, diagrams, sketches, 

and photographs, as appropriate.

• Show locations of safety-related equipment and features, as required in 10 CFR Part 36.

• Provide a construction schedule for the irradiator.

• Describe the site-specific testing frequency of all systems listed in 10 CFR 36.61.

Reference: NRC Manual Chapter 2815, entitled “Construction and Preoperational Inspection of 

Panoramic, Wet-Source-Storage Gamma Irradiators,” can be found under “Inspection Manual” 

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

8.9.2 Access Control

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.13(e), 10 CFR 36.23, 10 CFR 36.31(a), 

10 CFR 36.39(g), 10 CFR 36.41(g), 10 CFR 36.61

Criteria: Panoramic irradiator facilities must have access controls to prevent inadvertent entry 

into the radiation room if the sources are not in the shielded position, and underwater irradiator 

facilities must have a personnel access barrier to prohibit access to the irradiator when it is 

unattended, as required by 10 CFR 36.23.

Discussion: This section discusses two categories of irradiators:

• panoramic irradiators (dry-source-storage, wet-source-storage)

• underwater irradiators
8-23

Panoramic Irradiators

The door or barrier that serves as the primary access control system must have devices that will 

(1) prevent the source from being moved out of its shielded position if the door or barrier were 

open, and (2) cause the source to return to its shielded position if the door or barrier were 

opened while the source was exposed.

Product conveyor systems may serve as barriers as long as they reliably and consistently 

function as a barrier. It must not be possible to move the sources out of their shielded position if 

the door or barrier is open. Opening the door or barrier while the sources are exposed must 

cause the sources to return promptly to their shielded position. The personnel entrance door or 

barrier must have a lock that is operated by the same key used to move the sources. The doors 

and barriers must not prevent any individual in the radiation room from leaving.

The backup access control system must be able to detect entry while the source is exposed. If 

entry is detected, the system must (i) automatically cause the source to return to its shielded 

position, and (ii) activate audible and visible alarms.

Detection of entry while the sources are exposed must cause the sources to return to their fully 

shielded position and also must activate a visible and audible alarm to alert any individual 

entering the room to the hazard. The alarm must alert at least one other individual who is onsite 

and prepared to render or summon assistance promptly.

For panoramic irradiators that use a computer system to control the access control system, the 

licensee shall verify that the access control system will operate properly if offsite power is lost 

and shall verify that the computer has security features that prevent an irradiator operator 

from commanding the computer to override the access control system when it is required to 

be operable.

A radiation monitor must be provided to detect the presence of high radiation levels in the 

radiation room before personnel entry. The monitor must be integrated with personnel access 

door locks to prevent room access when radiation levels are high. Attempted entry while the 

monitor measures high radiation levels must activate the alarm described in 10 CFR 36.23(b). 

The monitor may be located in the entrance (normally referred to as the maze) but not in the 

direct radiation beam (e.g., an area of the maze that may expose the instrument directly to the 

irradiator sources when in the unshielded position).

The requirement in 10 CFR 36.23 for a door or other physical barrier applies to each entrance of 

the radiation room, whether intended for personnel or product entrance or exit. A conveyor 

system could meet the requirement by providing a clearance large enough for a package, but 

too small for a person, by using barriers that would require unusual exertion to bypass.

A photoelectric system cannot be considered a physical barrier. The purpose of this 

requirement is to prevent someone from carelessly or accidentally entering the radiation room 

while the sources are exposed.

This section also requires an independent backup access control system to provide a redundant 

means of preventing a person from being accidentally exposed to the source. In case of a 

failure of the interlocks on the door or barrier combined with a failure to follow operating 

procedures, the backup system should warn the person entering the radiation room of the 

danger and automatically cause the sources to return to their shielded position. The backup 
8-24

system could use photoelectric cells in an entrance maze, pressure mats on the floor, or similar 

means of detection. For example, the backup system can disengage the pneumatic system that 

controls the source rack movement by releasing all the compressed air from the system if an 

unauthorized entry is detected, causing the source to return to its shielded position by force of 

gravity. The system must alert another trained person, not inside the irradiator radiation area or 

maze, who is onsite and prepared to render or summon assistance.

The mechanism that moves the sources must require a key to actuate it. Actuation of the 

mechanism must cause an audible signal to indicate that the sources are leaving the shielded 

position. Only one key may be in use at any one time, and only irradiator operators or facility 

management may have access to it. The key must be attached to a calibrated portable 

radiation survey meter by a chain or cable. In addition, the lock for source control movement 

must be designed so that the key may not be removed if the sources are in an unshielded 

position. Also, the door to the radiation room must require the same key to open it. This 

redundant feature will ensure that the sources are in the shielded position prior to an individual 

entering the radiation room. It will also ensure that any individual entering the radiation room 

will have in his or her possession a calibrated portable radiation survey instrument for 

monitoring radiation levels in the radiation room, in the event the sources were not in the 

shielded position. In addition, the console of a panoramic irradiator must have a source position 

indicator that signals when the sources are in fully shielded position, when they are in transit, 

and when the sources are exposed.

Irradiators can produce ozone in concentrations exceeding those permitted by regulations of 

the Occupational Safety and Health Administration (OSHA) at 29 CFR 1910.1000, “Air 

Contaminants.” Nitrogen oxides can also be produced, although concentrations would not be 

expected to exceed OSHA’s limits. To control these gases, irradiators with large sources 

typically are equipped with ventilation systems to exhaust the gases before personnel entry.

OSHA regulates exposure to ozone and other noxious gases in the workplace, and the 

U.S. Environmental Protection Agency regulates emissions offsite. If NRC personnel observe 

problems with noxious gases at an irradiator during an inspection, NRC will notify OSHA of the 

problem under the terms of the “Memorandum of Understanding Between the U.S. Nuclear 

Regulatory Commission and the Occupational Safety and Health Administration; Worker 

Protection at NRC-Licensed Facilities,” signed September 6, 2013.

The radiation room must be equipped with a device integrated with the control system ensuring 

that the sources cannot be exposed unless the access door and other interlocks are engaged 

within a preset time of activating the control. The irradiator must be equipped with a safety timer 

that will automatically generate visible and audible warnings to alert personnel in the radiation 

room that the startup sequence has begun, provide sufficient time to leave the area and be 

equipped with at least one clearly identified emergency stop device that will abort the startup 

sequence. The safety timer must be integrated with the control system so that the source 

cannot be exposed unless the startup sequence is complete within the preset time and the 

control console indicates that it is safe to expose the source.

For panoramic irradiators whose construction began after July 1, 1993, the licensee must 

verify from the design and logic diagram that the access control system meets the 

requirements of 10 CFR 36.23. Before loading sources, the licensee must test the completed 

access control system to ensure that it functions as designed and that all alarms, controls, and 

interlocks work properly. For more information, see Appendix H of this NUREG, “Construction 

Monitoring and Acceptance Testing.”
8-25

Underwater Irradiators

The pool must be within an area surrounded by a personnel access barrier with an intrusion 

alarm when the facility is not attended. Only operators and facility management may have 

access to keys to the personnel access barrier. There must be an intrusion alarm to detect 

unauthorized entry when the personnel access barrier is locked. Activation of the intrusion 

alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon 

assistance when the alarm is activated.

Response from Applicant:

• Submit specific information describing the access control system (panoramic irradiators) 

or personnel access barrier (underwater irradiators) and how it works, which 

demonstrates compliance with the requirements of 10 CFR 36.23. Specific drawings or 

sketches should be submitted, as appropriate. Refer to Appendix O of this NUREG 

regarding exemptions that can be requested for teletherapy units converted to 

nonhuman use. 

• For panoramic irradiators, describe the facility alarm systems.

• For panoramic irradiators, describe the lock and key system for controlling source 

movement, and discuss how it meets the requirements of 10 CFR 36.31(a).

• Describe the site-specific testing frequency of the access control system 

(panoramic irradiators) or personnel access barrier (underwater irradiators). 

References: The “Memorandum of Understanding Between the U.S. Nuclear Regulatory 

Commission and the Occupational Safety and Health Administration,” signed 

September 6, 2013, can be found at https://www.nrc.gov/docs/ML1135/ML11354A432.pdf. 

8.9.3 Shielding

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.25, 10 CFR 36.39(a), 10 CFR 36.41(a), 

10 CFR 36.57,10 CFR 36.61

Criteria: Irradiator shielding must meet the requirements as described in 10 CFR 36.25, 

“Shielding,” and the requirements of local building codes or other appropriate sources.

Discussion: The radiation dose rate in areas that are normally occupied during operation of a 

panoramic irradiator may not exceed 0.02 mSv [2 mrem] per hour at any location 30 cm or more 

from the wall of the room when the sources are exposed. The dose rate must be averaged over 

an area not to exceed 100 cm2 having no linear dimension greater than 20 cm. The maximum 

dose rate of 0.02 mSv [2 mrem] per hour is considered practical to achieve. Areas where the 

radiation dose rate exceeds 0.02 mSv [2 mrem] per hour must be locked, roped off, or have 

appropriate warnings posted. These may include areas not normally occupied, such as the 

equipment access area on the roof of the irradiator.

The radiation dose at 30 cm over the edge of the pool of a pool irradiator may not exceed 

0.02 mSv [2 mrem] per hour when the sources are in the fully shielded position.
8-26

The radiation dose rate at 1 m from the shield of a dry-source-storage panoramic irradiator 

when the source is shielded may not exceed 0.02 mSv [2 mrem] per hour and at 5 cm from the 

shield may not exceed 0.2 mSv [20 mrems] per hour.

For panoramic irradiators:

• If not built in seismic areas, it is acceptable that shielding meet generally accepted 

building code requirements for reinforced concrete with walls, wall penetrations, and 

entranceways designed to meet the radiation shielding requirements of 10 CFR 36.25.

• If built in seismic areas, the applicant must design the reinforced concrete radiation 

shields to retain their integrity in the event of an earthquake by designing to the seismic 

requirements of an appropriate source, such as American Concrete Institute (ACI) 

Standard ACI 318-95, “Building Code Requirements for Reinforced Concrete,” 

Chapter 21, “Special Provisions for Seismic Design,” or local building codes, if current. 

Panoramic irradiators with steel plated radiation shields (filled with steel pellets) built in 

seismic areas should also be designed to the requirements of an appropriate source, 

such as the American National Standards Institute/American Institute of Steel 

Construction (ANSI/AISC) Publication 341-10, “Seismic Provisions for Structural Steel 

Buildings,” or local building codes, if current.

Note: “Seismic area” means any area where the probability of a horizontal acceleration in 

rock of more than 0.3 times the acceleration of gravity in 250 years is greater than 10 percent, 

as designated by the U.S. Geological Survey.

• American National Standards Institute (ANSI) Standard 43.10, “Safe Design and Use 

of Panoramic, Wet Source Storage Gamma Irradiators (Category IV) and Dry Source 

Storage Gamma Irradiators (Category II)” discusses geologic and seismic site 

considerations, which should be evaluated prior to building a panoramic irradiator.

• The licensee must monitor the construction of the shielding to verify that its 

construction meets design specifications and generally accepted building code 

requirements for reinforced concrete (see Appendix H of this NUREG).

• If the irradiator will use more than 2 × 1017 Bq [5 million Ci] of activity, the applicant 

must evaluate the effects of heating of the shielding walls by the irradiator sources 

(e.g., thermal effects on concrete).

Response from Applicant:

• For panoramic irradiators:

— Describe the shielding to be used and its composition.

— Submit a diagram showing the configuration of shielding, including walls and the 

ceiling, and indicate the thickness of each and penetrations in the shielding.

— For irradiators built in seismic areas, describe the design requirements for 

maintaining radiation shield integrity during an earthquake, to include geologic 

and seismic site considerations (e.g., geotechnical analysis) undertaken prior 

to construction.
8-27

— If any accessible areas outside the shield are expected to have a dose rate 

exceeding 0.02 mSv [2 mrem] per hour, identify the areas and explain how 

access will be controlled for radiation safety purposes.

— For requests to possess more than 2 × 1017 Bq [5,000,000 Ci], submit an 

evaluation of the effects of heating of the shielding walls by the 

irradiator sources.

— Describe the testing frequency of the irradiator shielding as required by 

10 CFR 36.57, “Radiation surveys.”

Note: For additional guidance regarding shielding and foundation requirements, refer to

Inspection Manual Chapter 2815 “Construction and Preoperational Inspection of Panoramic,

Wet-Source-Storage Gamma Irradiators,” which was discussed previously and referenced in 

Section 8.9.1 “General Description of the Facility and Site.”

For underwater irradiators: No response is required from the applicant in a 

license application.

Notes:

• The NRC does not approve irradiator shield designs. Instead, the NRC conducts 

inspections to ensure that the maximum dose rate outside the completed shield is within

NRC requirements.

• The applicant should identify building code requirements to which shielding walls will be 

built, and inspections of the construction that will be performed by local authorities so 

that the license reviewer can confirm that they do not adversely impact the NRC 

requirements.

Reference: Standard 318-95 is available for purchase from ACI at

https://www.concrete.org/store.aspx.

8.9.4 Fire Protection

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.27, 10 CFR 36.39(h), 10 CFR 36.41(h), 

10 CFR 36.61

Criteria: Panoramic irradiators must have smoke and heat detectors to detect a fire, to activate 

alarms, and to cause the source rack to automatically become fully shielded to meet the 

requirements as described in 10 CFR 36.27, “Fire protection,” and 10 CFR 36.39(h).

Discussion: The radiation room must have heat and smoke detectors that activate an audible 

alarm capable of alerting a person who can summon assistance promptly. The sources must 

become fully shielded automatically if a fire or smoke is detected.

The radiation room must be equipped with a fire extinguishing system capable of extinguishing 

a fire without the entry of personnel into the room. The system for the radiation room must have 

a shut-off valve to control flooding into unrestricted areas.
8-28

The fire extinguishing system is required because a fire could disable the access control system 

or could prevent the sources from being shielded, thereby lowering the margin of safety. 

During a fire, there would be no means of ensuring that the access control systems and source 

position indicators or the mechanism that returns the source to the shielded position had 

operated properly.

For panoramic irradiators:

• The applicant must verify that the number, location, and spacing of the smoke and heat 

detectors are appropriate to detect fires and that the detectors are protected from 

mechanical and radiation damage. The applicant must verify that the design of the fire 

extinguishing system provides the necessary discharge patterns, densities, and flow 

characteristics for complete coverage of the radiation room and that the system is 

protected from mechanical and radiation damage. The applicant must verify that the 

design of the fire extinguishing system provides the necessary discharge patterns, 

densities, and flow characteristics for complete coverage of the radiation room and that 

the system is protected from mechanical and radiation damage.

• The licensee must test the ability of the heat and smoke detectors to detect a fire, to 

activate alarms, and to cause the source rack to automatically become fully shielded. In 

addition, the licensee must test the operability of the fire extinguishing system. It is not 

required that licensees turn on extinguishers (i.e., water or chemicals) during tests of the 

operability of their fire protection systems. For more information, see “Radiation Safety 

Program - Inspection and Maintenance Checks” and Appendix H of this NUREG, 

“Construction Monitoring and Acceptance Testing.”

Response from Applicant:

• For panoramic irradiators, describe

— the type and location of the heat and smoke detectors to be used to detect a fire 

in the radiation room (Refer to Appendix O of this NUREG regarding exemptions 

that can be requested for teletherapy units converted to nonhuman use)

— the alarms to alert personnel trained to summon assistance

— how the sources will automatically become fully shielded if a fire is detected

— how the heat and smoke detectors will be tested and the testing frequency

For underwater irradiators: No response is required, because the sources are always 

underwater and not subject to damage by fire.

8.9.5 Radiation Monitors

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.13(e), 10 CFR 36.23(c), 10 CFR 36.29, 

10 CFR 36.39(e), 10 CFR 36.41(e), 10 CFR 36.59(b), 10 CFR 36.61

Criteria: Irradiator facilities must have radiation monitors to detect radiation levels and the 

presence of sources as described in 10 CFR Part 36.
8-29

Discussion: This section will only discuss the evaluation of the location of radiation monitors. 

For information regarding the calibration, sensitivity, and testing of monitors, see Section 8.10.2, 

“Radiation Safety Program - Instruments.”

For irradiators with automatic product conveyor systems

The irradiator must have a radiation monitor with an audible alarm located to detect loose 

radioactive sources that are carried toward the product exit. If the monitor detects a source, an 

alarm must sound and product conveyors must stop automatically. The alarm must be capable 

of alerting a trained individual in the facility who is prepared to summon assistance.

For panoramic irradiators

A monitor must be provided to detect the radiation level in the radiation room before personnel 

entry. The monitor must be integrated with the personnel access door interlocks, as applicable, 

to prevent room access when the monitor detects an elevated radiation level for which the alarm 

set point is as low as practical but high enough to avoid false alarms. Room access must also 

be prevented if the monitor malfunctions or is turned off.

An administrative procedure cannot be substituted for this engineering control. To 

avoid an extended shutdown, licensees may want to consider maintaining replacement 

radiation monitors in the event a radiation monitor malfunctions. 

For underwater irradiators that are not in a shielded radiation room

There must be a radiation monitor over the pool to detect abnormal radiation levels. The 

monitor must have an audible alarm and a visible indicator at entrances to the personnel access 

barrier around the pool. The audible alarm may have a manual shut-off. The alarm must be 

capable of alerting an individual who is prepared to respond promptly (e.g., prevent movement 

of irradiated product out of the pool in the event water is contaminated, or in the event that a 

loose source is embedded in the product carrier).

For all irradiators

• The licensee must ensure that the location and sensitivity of the monitor used to detect 

sources carried by the product conveyor system are appropriate.

• The licensee must verify that the product conveyor is designed to stop before a source 

on it could cause a radiation overexposure to any person.

For all irradiators, the licensee must verify the operability of radiation monitors and related 

alarms and interlocks prior to loading sources. For more information, see Appendix I of this 

NUREG.

For pool irradiators

• If the licensee uses radiation monitors to detect contamination under 10 CFR 36.59(b), 

the licensee must verify that the design of radiation monitoring systems to detect pool 

contamination includes sensitive detectors located close to where contamination is likely 

to be concentrated.
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Response from Applicant:

• Describe the location and type of radiation monitors that will be used to meet the 

requirements of 10 CFR 36.23(c), 10 CFR 36.29, “Radiation monitors,” and 

10 CFR 36.59(b).

• Describe the location and types of alarms and those individuals who are trained to 

respond to those alarms. Diagrams and sketches should be used, as appropriate.

• Discuss the alarm set points or the methods for establishing the alarm set points.

• Describe the evaluation performed to meet 10 CFR 36.39(e) on detector location and 

sensitivity and the acceptance testing that will be performed to meet 10 CFR 36.41(e).

• Describe the testing frequency of radiation monitors. 

Note: In accordance with 10 CFR 37.49, licensees must 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. Radiation monitors may be used as part of a security plan. 

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

be subject to review and inspection.

8.9.6 Irradiator Pools

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.23(i), 10 CFR 36.33, 10 CFR 36.39(c), 

10 CFR 36.39(d), 10 CFR 36.41(c), 10 CFR 36.41(d), 10 CFR 36.61

Criteria: Irradiator facilities with pools must be designed and equipped as described in 

10 CFR Part 36.

Discussion: The NRC requires that irradiator pools must either

Have a water-tight stainless steel liner (or a liner metallurgically compatible with other 

components in the pool)

OR

Be constructed so that there is a low likelihood of substantial leakage and have a surface 

designed to facilitate decontamination.

The purpose of the requirement is to reduce the likelihood of the pool leaking water that is used 

for shielding purposes and may be contaminated. Therefore, the design of the water handling 

and purification system must ensure that water leaking from the system does not drain to 

unrestricted areas without being monitored.

In either case, the licensee must have a method to store the sources safely during repairs of 

the irradiator pool.
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Irradiator pools must have no outlets more than 0.5 m below the normal low water level that 

could allow water to drain out of the pool. Pipes that have intakes more than 0.5 m below the 

normal low water level and that could act as siphons must have siphon breakers to prevent 

siphoning. Irradiator pools must have a means to replenish water that is lost. The means to 

replenish the water does not have to be automatic. Irradiator pools must also have a clearly 

visible indicator to show if the pool water level is above or below the normal low water level.

For all pool irradiators

• A physical barrier, such as a railing or cover, must be used around or over irradiator 

pools during normal operation to prevent personnel from accidentally falling into the 

pool. The barrier may be removed during maintenance, inspection, and service 

operations. Also, this ensures compatibility with OSHA requirements and 

ANSI standards.

• The pool shall be designed to ensure that it is leak resistant, that it is strong enough to 

bear the weight of the pool water and shipping casks, that a dropped cask would not fall 

on sealed sources, that all outlets or pipes meet the requirement of 10 CFR 36.33(b), 

and that metal components are metallurgically compatible with other components in 

the pool.

• Irradiator pools must be equipped with a purification system capable of maintaining the 

water during normal operation at a conductivity of 20 microsiemens per centimeter or 

less and with enough clarity to allow for inspection of the source and source rack for 

damage and proper position. The water purification system is needed to minimize the 

probability of corrosion of the sealed sources and the source rack.

• The 0.02 mSv [2 mrem] per hour limit on the dose rates for poles and long-handled tools 

to be used in irradiator pools is imposed to prevent radiation streaming. Hollow and 

low-density poles and tools can have either vent holes to allow shielding water to enter 

or sufficient bends to prevent radiation levels at handling areas of the tools from 

exceeding 0.02 mSv [2 mrem] per hour.

The licensee must verify that the pool design ensures its integrity as required by 

10 CFR 36.39(c) and that the design of the water purification system is adequate. The 

licensee must also conduct inspections and tests of the pool and water handling systems to 

meet the requirements of 10 CFR 36.41(c) and (d) (see Appendix I of this NUREG).

Response from Applicant: Provide the following:

• For all pool irradiators, describe:

— The pool water-liner—If no water-tight stainless steel liner or a liner 

metallurgically compatible with other components in the pool is used, explain why 

the pool has a low likelihood of substantial leakage and how decontamination 

could be accomplished if necessary.

— The high and low water-level indicators and their locations.

— The purification system for the pool, with an explanation of why it is capable of 

maintaining pool water conductivity less than 20 microsiemens per centimeter.
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— The means to replenish pool water, including significant water losses, from a 

position external to the radiation room, when necessary.

— The barrier used during normal operation to prevent personnel from falling into 

the pool.

— How high radiation doses from radiation streaming will be minimized when using 

long-handled tools or poles (use sketches if appropriate).

— The pool outlets—If the pool has outlets more than 0.5 m below the surface that 

could allow water to drain out of the pool, the means of preventing inadvertent 

excessive loss of pool water (in this context, outlets do not include transfer tubes 

between adjacent pools, because the transfer tubes do not provide a means to 

allow water to drain out of the pools).

— The testing frequency of multiple regulatory required systems as listed in 

10 CFR 36.61, “Inspection and maintenance.”

8.9.7 Source Rack

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.35, 10 CFR 36.39(f), 10 CFR 36.41(f), 

10 CFR 36.61

Criteria: Systems must be in place to protect the source rack.

Discussion: An important element in a radiation safety program is providing systems to protect 

the source rack and the mechanism that moves the rack.

For all irradiators, if the product to be irradiated moves on a product conveyor system, the 

source rack and the mechanism that moves the rack must be protected by a barrier or guides to 

prevent products and product carriers from hitting or touching the rack or mechanism.

• For pool irradiators, the licensee must verify that there are no crevices on the source or 

between the source and source rack that would promote corrosion on a critical area of 

the source (e.g., crevice corrosion, an inaccessible location in or around the sources or 

rack with low oxygen concentrations).

• For panoramic irradiators, the licensee must determine that source rack drops due to 

loss of power will not damage the source rack and that source rack drops due to failure 

of cables (or alternate means of support) will not cause loss of integrity of sealed 

sources. In addition, licensees should review the potential of sealed sources to become 

dislodged from the source rack when dropped as a result of loss of power, failure of 

cables, or other alternate means of support.

• For panoramic irradiators, the licensee must review the design of the mechanism that 

moves the sources to ensure that the likelihood of a stuck source is low and that, if the 

rack sticks, a means exists to free it with minimal risk to personnel.

• For panoramic irradiators, the licensee must test the movement of the source racks for 

proper operation prior to source loading; testing must include source rack lowering due 

to simulated loss of power.
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• For all irradiators with product conveyor systems, the licensee must observe and test the 

operation of the conveyor system to ensure that the requirements in 10 CFR 36.35 

“Source rack protection,” are met for protection of the source rack and the mechanism 

that moves the rack. Testing must include tests of any limit switches and interlocks 

used to protect the source rack and mechanism that moves the rack from moving 

product carriers.

See Appendix H of this NUREG, “Construction Monitoring and Acceptance Testing.”

Response from Applicant: Submit procedures for ensuring source rack protection and testing 

frequency of the source rack protection system. If the product moves on a product conveyer 

system, describe the source rack protection to be provided to prevent products and product 

carriers from touching the source rack or mechanism that moves the rack. Provide diagrams or 

sketches of those systems, if appropriate.

For panoramic irradiators

Describe any safety and emergency actions to be taken if a source is stuck or if a rack sticks. 

Explain how and how often observation and testing of the conveyor system will occur to ensure 

that the requirements in 10 CFR 36.35 are met.

8.9.8 Power Failures

Regulations: 10 CFR 30.33(a)(2), 10 CFR 36.37, 10 CFR 36.39(i), 10 CFR 36.41(i), 

10 CFR 36.41(j), 10 CFR 36.61

Criteria: If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the 

sources must automatically return to the shielded position. In addition, the lock on the door of 

the radiation room of a panoramic irradiator must not be deactivated by a power failure.

Discussion: Automatic source retraction, in case of power loss, must be accomplished without 

offsite power. The loss of offsite power may occur at irradiator facilities due to means outside 

the control of the licensee. In those cases where loss of offsite power occurs, the licensee is 

responsible for ensuring that the sources automatically return to the shielded position, in 

accordance with 10 CFR 36.37(a). This is normally accomplished by an irradiator design that 

does not need electrical energy to return the sources to their shielded position. In addition, 

10 CFR 36.37(b) requires that the lock on the door of the radiation room may not be deactivated 

as the result of a power failure. It also requires that during a power failure, the licensee must 

ensure that anyone entering the area of any irradiator where sources are located must use an 

operable and calibrated radiation survey meter.

The licensee needs to demonstrate how the source rack would return into the shielded position 

in the event of a power outage and what effects the loss of power would have on the lock of the 

door to the radiation room that contains the sources. If the locks on the doors did not function 

as designed and allowed entry into the radiation room, the licensee would need to have 

procedures in place to ensure that safety features would prevent an individual from being 

exposed to the sources if they did not return to the shielded position. Backup power is not 

required, as long as loss of power will cause the source to return to its shielded position

(e.g., the source returns to the shielded position due to gravity).
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For panoramic irradiators that use a computer system to control the access control system, the 

licensee shall verify that the access control system will operate properly if offsite power is lost 

and shall verify that the computer has security features that prevent an irradiator operator 

from commanding the computer to override the access control system when it is required to 

be operable.

The licensee must test the ability of the source rack to return to its shielded position during a 

power loss greater than 10 seconds. For more information; see Appendix I of this NUREG.

In accordance with 37.49(a), licensees shall establish and maintain the capability to 

continuously monitor and detect without delay all unauthorized entries into its security zones. 

Licensees shall provide the means to maintain continuous monitoring and detection capability in 

the event of a loss of the primary power source, or provide for an alarm and response in the 

event of a loss of this capability to continuously monitor and detect unauthorized entries. This 

requirement will be addressed in a licensee’s security plan.

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 panoramic irradiators:

• Describe how the sources are automatically returned to the shielded position if offsite 

power is lost for longer than 10 seconds.

• Describe how loss of power will affect the lock on the doors in the radiation room.

• For panoramic irradiators that use a computer system to control access: Describe how 

the access control system will operate properly if offsite power is lost. Describe how 

computer security features prevent an irradiator operator from commanding the 

computer to override the access control system.

• Describe the site-specific testing frequency to ensure that sources are returned to the 

shielded position if offsite power is lost for longer than 10 seconds. 

For underwater irradiators: No response is required from the applicant in a 

license application.

8.10 Item 10: Radiation Safety Program

8.10.1 Audit and Review of Program

Regulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 37.33, 10 CFR 37.55
8-35

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

programs at least annually to ensure the following:

• compliance with NRC and DOT regulations (as applicable), and the terms and conditions 

of the license

• occupational doses and doses to members of the public are ALARA 

Records of audits and other reviews of program content are maintained for 3 years after the 

record is made.

Licensees that possess an aggregated Category 1 or Category 2 quantity of radioactive material 

must annually review their access authorization program, and security program.

Discussion: Appendix I of this NUREG contains a suggested annual audit program that is 

specific to the use of irradiators and is acceptable to the NRC. Because all areas indicated in 

Appendix I may not be applicable to every licensee and all items may not need to be addressed 

during each audit, licensees may wish to develop a program-specific audit checklist. 

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

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

the audit program, licensees should consider including unannounced audits to determine

whether radiation safety procedures are being followed.

It is essential that when problems are identified, comprehensive corrective actions are taken in a 

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

and Implementation of Corrective Action,” dated May 1, 1996, provides guidance on this 

subject. The NRC routinely reviews licensee’s records to verify whether appropriate corrective 

actions were implemented in a timely manner to prevent recurrence. It is in the best interest of 

the licensee to identify potential violations of regulatory requirements and take necessary steps 

to correct them. The NRC can opt to exercise discretion and may elect not to cite the licensee 

for these violations if prompt and effective corrective actions are implemented. The NRC’s 

Enforcement Policy may be found online at https://www.nrc.gov/aboutnrc/regulatory/enforcement/enforce-pol.html. The Enforcement Manual may be found online at

https://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. For examples of the 

NRC’s use of discretion in issuing a notice of violation, refer to the most recent version of NRC’s 

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

With regard to audit records, 10 CFR 20.2102 requires, in part, that licensees maintain records 

of audits and other reviews of program content and implementation for 3 years after the record 

is made. The NRC has found audit records that contain the following information to be 

acceptable: (i) date of audit, (ii) name of person(s) who conducted the audit, (iii) persons 

contacted by the auditor(s), (iv) areas audited, (v) audit findings, (vi) corrective actions, and 

(vii) follow-up.
8-36

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

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

• In accordance with 10 CFR 37.33, 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.

• In accordance with 10 CFR 37.55, review its security program at least annually to 

confirm compliance with the requirements of Subpart C of 10 CFR Part 37, and ensure 

that comprehensive actions are taken to correct any noncompliance that is identified.

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

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

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

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

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

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

be subject to review and inspection.

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

program to the NRC for review as part of a license application. See Appendix I for a sample 

radiation safety audit program. The NRC may examine audits during inspections to determine 

compliance with NRC regulations. 

Reference: IN 96-28, “Suggested Guidance Relating to Development and Implementation of 

Corrective Action,” dated May 1, 1996, can be found under “Generic Communications” at 

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

8.10.2 Radiation Monitoring Instruments

Regulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2), 10 CFR 36.23(c), 

10 CFR 36.27(a), 10 CFR 36.29, 10 CFR 36.39(e), 10 CFR 36.41(e), 10 CFR 36.57(c), 

10 CFR 36.57(e), 10 CFR 36.59(b), 10 CFR 36.63(b), 10 CFR 36.81(f)

Criteria: The NRC requires specific types of instruments to perform radiation surveys and to 

monitor certain activities.

Radiation Survey Instruments

Surveys that are required before and during operation of all types of irradiators require using 

survey instruments, which

• measure the type of radiation expected and are adequate in number, type, and range of 

dose-rate to support normal and emergency operations

• are calibrated:

— at least annually using a source of radiation similar to that found in the irradiator
8-37

— after any servicing or repair (other than a battery exchange)

— to ensure that exposure rates indicated by the meter do not vary from the actual 

exposure rates by more than ± 20 percent on each scale

— by the instrument manufacturer or person specifically authorized by the NRC or 

an Agreement State to calibrate survey instruments

• do not saturate and read zero at high radiation dose rates

Radiation Monitors

The requirements for use of radiation monitors are shown in Table 8-2.

Table 8-2. Requirements for Radiation Monitors

Type of Irradiator Monitor Required Purpose of Monitor Required Checks

Panoramic Gamma sensing 

integrated with 

personnel access 

locks. Must activate 

alarm if entry is 

attempted while 

sensing radiation.

10 CFR 36.23(c)

Detects presence of 

high radiation in 

radiation room to 

prevent room access 

when radiation levels 

are high.

Periodic checks with 

radioactive check 

source to confirm 

operability.

All pool types 

(required unless water 

is checked daily by 

analysis of a sample 

of pool water)

Gamma sensing of 

pool circulating 

system. Must 

activate an alarm set

point as low as 

practical when pool is 

contaminated.

10 CFR 36.59(b)

Detects a possible 

leaking sealed 

source.

Periodic checks with 

radioactive check 

source to confirm 

operability and 

sensitivity.

Underwater type not in 

a shielded radiation 

room

Gamma sensing 

mounted over the 

pool. Must have an 

audible alarm capable 

of alerting an 

individual who is 

prepared to respond 

promptly and a visible 

indicator at entrances 

to the personnel 

access barrier around 

the pool.

10 CFR 36.29(b)

Detects abnormal 

radiation levels.

Periodic checks with 

radioactive check 

source to confirm 

operability and 

sensitivity.

Any irradiator using a 

product conveyor 

system

Gamma sensing with 

an audible alarm to 

detect loose 

Must stop conveyor 

before a source on 

the conveyor can 

Periodic checks with 

radioactive check 

source to confirm 
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Table 8-2. Requirements for Radiation Monitors

Type of Irradiator Monitor Required Purpose of Monitor Required Checks

radioactive sources 

that are carried 

toward the product 

exit. Alarm must alert 

an individual who is 

prepared to summon 

assistance. 

10 CFR 36.29(a)

10 CFR 36.39(e)

cause a radiation 

overexposure to any 

person.

operability. The 

location and sensitivity 

of the monitor to 

detect sources carried 

by the product 

conveyor must be 

evaluated.

Discussion: Irradiator licensees must have survey instruments and radiation monitors as 

shown in Figure 8-5.

Figure 8-5. Radiation Detection Instruments

Irradiator licensees must have a variety of radiation detection instruments, 

including portable survey instruments and fixed radiation monitors.

Radiation Survey Instruments

The survey instruments should measure at least 0.05 mR through 200 mR per hour [2 mSv] and 

be checked for functionality with a source of radiation at the beginning of each day of use 

(e.g., with a check source). Plans to conduct nonroutine operations, such as installation, initial 

radiation survey, repair, and maintenance of components related to the radiological safety of the 

irradiator, sealed source relocation, replacement, and disposal of sealed sources, alignment or 

removal of a sealed source from service must include an evaluation of the type of survey 

instrument to be used because some of these operations may increase the individual’s risk of 

radiation exposure. These operations should be carefully monitored with an appropriate survey 

meter. Furthermore, proper calibration of a survey meter is important for initial surveys since 

they can be used as a basis for public dose estimates. For those licensees requesting 

authorization to calibrate their own survey instruments, Appendix J of this NUREG contains 

calibration procedures acceptable to the NRC. 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).
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Nonroutine operations are typically performed by the source manufacturer or distributor, or a 

service provider licensee that is specifically authorized to perform such services. Applicants 

requesting authorization to perform nonroutine operations should submit operating and 

emergency procedures that are specific for the type of operation that is being proposed. The 

NRC will review these procedures to determine if the procedures are adequate to protect the 

workers and members of the public. See Appendix G of this NUREG, “Information Needed to 

Support Applicant’s Request to Perform Nonroutine Operations,” for further guidance.

Radiation Monitors

Fixed radiation monitors are used to detect the presence of radiation for various purposes at 

irradiator facilities. They are vital to access control systems because they provide electronic 

signals used to activate both audible and visual alarms when radiation is present. Monitors that 

warn individuals of the presence of high radiation or that are integrated with personnel access 

door locks to prevent room access under high radiation conditions should be designed to

provide fail-safe operation (i.e., if the radiation monitor for any reason fails to respond to 

radiation), the system should provide for a backup warning system.

Response from Applicant:

For Radiation Survey Instruments: Provide one of the following:

• A statement that: “We will use survey instruments that meet the criteria in the section 

entitled ‘Radiation Safety Program - Instruments’ in NUREG–1556, Volume 6, 

Revision 1, ‘Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About 10 CFR Part 36 Irradiator Licenses.’”

AND ONE OF THE FOLLOWING:

• A statement that: “Each survey meter will be calibrated by the manufacturer or 

other person authorized by the NRC or an Agreement State to perform survey 

meter calibrations.”

OR

• A statement that, “We will implement the model survey meter calibration program 

published in Appendix J “Model Radiation Survey Instrument Calibration’ in 

NUREG–1556, Volume 6, Revision 1, ‘Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses.’”

OR

• Submit alternative calibration procedures for NRC review.

For Radiation Monitors: Describe the type of monitors used to meet the requirements of 

10 CFR 36.23(c), 10 CFR 36.29, 10 CFR 36.39(e), and 10 CFR 36.59(b). (The location of 

these monitors and alarm set-points were described in the response to “Facilities and 

Equipment - Radiation Monitors.”)
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Notes:

• The NRC license will state that survey meter calibrations will be performed by the 

instrument manufacturer or a person specifically authorized by the NRC or an 

Agreement State to calibrate instruments, unless the applicant specifically requests this 

authorization. Applicants seeking authorization to perform survey meter calibrations 

must submit additional information for review. See Appendix J for more information.

• Regardless of whether an applicant is authorized to calibrate survey meters or contract a 

licensed entity authorized to perform calibrations, the licensee must retain calibration 

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

8.10.3 Material Receipt and Accountability

Regulations: 10 CFR 20.1501(a), 10 CFR 20.1801, 10 CFR 20.1802, 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 37.49, 10 CFR 37.71, 10 CFR 37.75, 10 CFR 37.77

Criteria: Licensees must do the following:

• Develop, maintain, and implement a procedure to account for licensed material.

• Maintain records of receipt, transfer, and disposal of sources and devices.

• Update transactions in the 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.

Discussion: While loss, theft, or misplacement of licensed material at most irradiator facilities 

is unlikely because of limited access to sealed sources and the hazards involved with 

approaching unshielded sources, accountability for licensed materials must be ensured. As 

illustrated in Figure 8-6, licensed materials must be tracked from “receipt to disposal” to ensure 

accountability at all times; identify when licensed material may be lost, stolen, or misplaced; and 

to ensure that possession limits listed on the license are not exceeded. 
8-41

Figure 8-6. Material Receipt and Accountability

Licensees must maintain records of receipt, transfer, and disposal and 

implement an accountability procedure.

Because this NUREG covers various types of irradiators, it is not possible to prescribe a specific 

procedure for material accountability that will apply to every situation. In developing a licensed 

material accountability program, the applicant should take into consideration the specific 

conditions at its facility. Table 8-3 includes elements that may be included in the accountability 

procedure for various facilities. 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.

Table 8-3. Elements of Accountability Procedure

Irradiator Type Items to be Addressed in Accountability Procedure

Pool irradiator Verify that no sources have been lost when sources are 

added to, removed from, or moved within the irradiator.

Maintenance of records that include sealed source serial 

numbers and location of each source

Panoramic dry-source-storage 

irradiator (including teletherapy 

units converted to irradiators)

Leak tests

Verify that no sources have been lost when sources are 

added to, removed from, or moved within the irradiator.

Maintenance of records that include sealed source serial 

numbers and location of each source

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 the activity (in units of becquerels or curies) of byproduct material, and 

date of measurement of each sealed source
8-42

• manufacturer’s (or distributor’s) name, model number, and serial number of each sealed 

source containing byproduct material

• location of each sealed source

• for materials transferred or disposed of, the date of the transfer or disposal, name and 

license number of the recipient, description of the affected radioactive material 

(e.g., radionuclide, activity, manufacturer’s (or distributor’s) name and model number, 

and serial number)

• date when accountability evaluation was performed

• name with signature of individual performing accountability

Category 1 and Category 2 sources listed in Appendix E to 10 CFR Part 20 (i.e., nationally 

tracked sources) must be tracked in the NSTS in accordance with 10 CFR 20.2207. The 

regulations in 10 CFR 20.2207 require that each licensee that manufactures, transfers, 

receives, disassembles, or disposes of a nationally tracked source shall complete and submit a 

National Source Tracking Transaction Report (NSTTR) to the NRC. The NSTTRs are 

maintained in the NSTS, a secure computer system that tracks Category 1 and Category 2 

nationally tracked sources from the time they are manufactured or imported through the time of 

their disposal or export, or until the source activity decays to below Category 2.

There are additional security requirements for shipment and transfer of a Category 1 and 

Category 2 quantity of radioactive material listed in Appendix A to 10 CFR Part 37. Prior to 

transferring Category 1 or Category 2 quantities of radioactive material, licensees must use 

NRC’s license verification system (or contact the licensing authority) to verify that the recipient 

licensee is authorized to possess the radioactive material. Licensees that ship Category 1 or 

Category 2 quantities of radioactive material must preplan and coordinate such shipments in

accordance with 10 CFR 37.75. Shipments of Category 1 quantities are also subject to the 

10 CFR 37.77 advance notification requirements. For additional guidance on implementing 

10 CFR Part 37 requirements, see NUREG–2155, “Implementation Guidance for 

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

Material.”” Additional information regarding best practices for protection of risk-significant 

radioactive material is available in NUREG–2166, “Physical Security Best Practices for the 

Protection of Risk-Significant Radioactive Material.”

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

be subject to review and inspection.

Table 8-4. Receipt, Transfer, and Disposal Record Maintenance

Type of Record How Long Record Must be Maintained

Receipt For as long as the material is possessed and for

3 years following transfer or disposal of the material

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 the section entitled, “Financial Assurance and Recordkeeping for Decommissioning.”
8-43

Response from Applicant: Provide the following:

• A procedure (or procedures) for ensuring material accountability

OR

• A statement that: “We will develop, implement, and maintain procedures for ensuring 

accountability of licensed materials at all times.”

AND

• A statement declaring that: “We will comply with the NSTS reporting requirements as 

described in 10 CFR 22.2207.”

8.10.4 Occupational Dosimetry

Regulations: 10 CFR 19.13, 10 CFR 20.1201, 10 CFR 20.1207, 10 CFR 20.1208,

10 CFR 20.1501(c), 10 CFR 20.1502, 10 CFR 36.55

Criteria: The requirements for occupational dosimetry are shown in Table 8-5.

Discussion: The regulations in 10 CFR 36.55(a) require that irradiator operators shall wear a 

personnel dosimeter that is processed and evaluated by an accredited National Voluntary 

Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or 

while in the area around the pool of an underwater irradiator. The National Institute of 

Standards and Technology maintains a directory of laboratories that are NVLAP-accredited at 

http://ts.nist.gov/standards/scopes/dosim.html. Regulations in 10 CFR 36.55(b) require, in part, 

that other individuals who enter the radiation room of a panoramic irradiator shall wear a 

dosimeter, which may be a pocket dosimeter. 

The requirements for most individuals are described in Table 8-5. Note that in accordance with 

10 CFR 20.1207, the annual occupational dose limits for minors are 10 percent of the annual 

dose limits specified for adult workers. Also, 10 CFR 20.1208 requires the licensee to ensure 

that the dose equivalent to the embryo/fetus during the entire pregnancy, due to the 

occupational exposure of a declared pregnant woman, does not exceed 0.5 rem [5 mSv]. 

Other individuals who perform certain nonroutine operations (e.g., source loading, unloading, 

and repositioning, troubleshooting the control console, clearing stuck source racks, investigating

and remediating removable contamination and leaking sources, (re)installing source cables, and 

any other activity during which personnel could receive radiation doses exceeding NRC limits) 

are likely to exceed 10 percent of the limits shown in Figure 8-7 (see Appendix G, “Information 

Needed to Support Applicant’s Request to Perform Nonroutine Operations”). Applicants also 

will be required to provide dosimetry (whole body and perhaps extremity monitors) to individuals 

performing such services.

When personnel monitoring is needed, most licensees use film badges, thermoluminescent 

dosimeters (TLDs), or optically stimulated luminescence dosimeters (OSLDs) that are supplied 

by a NVLAP-accredited processor. The exchange frequency for film badges is at least monthly

because of technical concerns about film fading. The exchange frequency for TLDs and OSLDs 

is at least quarterly. Applicants should verify that the processor is NVLAP-accredited. Consult 
8-44

the NVLAP-accredited processor for its recommendations for exchange frequency and 

proper use.

Some workers (e.g., package handlers, shipping personnel, and custodial personnel) may work 

near the irradiator but are not likely to exceed 10 percent of the limits. Refer to Appendix K of 

this NUREG for guidance for demonstrating that an unmonitored individual will not exceed 

10 percent of the limits.

Table 8-5. Requirements for Occupational Dosimetry

Type of 

Irradiator Category of Personnel Type of Dosimetry

When Dosimetry Must 

Be Worn

Panoramic Irradiator operators Film, TLD, or OSLD When operating irradiator

Underwater Irradiator operators Film, TLD, or OSLD When in area 

around pool

Panoramic Other individuals, 

including visitors (for 

groups of visitors, it is 

sufficient for two to be 

monitored)

Pocket dosimeter, film, 

TLD, or OSLD 

When entering or in 

radiation room

All Anyone who could 

receive, in a year, a 

radiation dose in excess 

of 10% of the allowable 

limits, as shown in 

Figure 8-8.*

Pocket dosimeter, film, 

TLD, or OSLD 

As directed by the RSO,

based on 

10 CFR 20.1502

*The licensee must maintain, for inspection by the NRC, documentation demonstrating that unmonitored individuals 

are not likely to receive, in a year, a radiation dose in excess of 10 percent of the allowable limits, as shown in 

Figure 8-8.

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

Dose Limits for

Adult Radiation Worker

(10 CFR 20.1201)
8-45

Total effective dose equivalent (TEDE) equals the effective dose equivalent 

(for external exposures) plus the committed effective dose equivalent (for internal exposures).

Response from Applicant: Provide the following:

• A statement that: “Film, TLD, or other dosimetry devices are processed and evaluated 

by an NVLAP-accredited processor.”

• A statement that: “Film, TLD, or other personnel dosimetry devices will be exchanged at 

the required frequency and will be assigned to and worn by irradiator personnel.

• A statement that: “Other individuals, including visitors, entering a radiation room will be 

provided dosimetry in accordance with regulatory requirements.

8.10.5 Public Dose

Regulations: 10 CFR 20.1003, 10 CFR 20.1301, 10 CFR 20.1302, 10 CFR 20.1801, 

10 CFR 20.1802, 10 CFR 20.2107, 10 CFR 36.25

Criteria: Licensees must do the following:

• Ensure that irradiators and their sealed sources will be used, transported, and stored in 

such a way that individual members of the public will not receive more than 1 mSv 

[100 mrem] in a year, and the dose in any unrestricted area will not exceed 0.02 mSv 

[2 mrem] in any one hour, from licensed operations.

• Control and maintain constant surveillance over licensed material that is not in storage,

and secure stored licensed material from unauthorized access, removal, or use.

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 doses received 

from background radiation and medical procedures. Whether the dose to an individual is an 

occupational dose or a public dose depends on the individual’s assigned duties. It does not 

depend on the area (restricted, controlled, or unrestricted) where the individual is when he or 

she receives the dose.

Members of the public include all persons who are not radiation workers. This includes persons 

who work or may be near locations where licensed material is used or stored and employees 

whose assigned duties do not include the use of licensed materials and who work in the vicinity 

where licensed material is used or stored.

Security procedures described in “Facilities and Equipment - Access Control,” “Radiation Safety 

Program—Operating Procedures,” and “Radiation Safety Program—Emergency Procedures,”

should be sufficient to limit the exposure to the public during use or storage. Public dose is 

controlled, in part, by ensuring that irradiators are secure (e.g., irradiator is locked or located in 

a locked area) to prevent unauthorized access or use. Irradiator use is usually restricted by 

controlling access to the keys needed to operate the irradiator and to keys to the locked 

irradiator area. Only authorized users or facility management should have access to 

these keys.
8-46

Public dose also is affected by the choice of storage and use locations and conditions. Because 

an irradiator produces a radiation field, it must be located and constructed so that the dose in an 

unrestricted area (e.g., an office or the exterior surface of an outside wall) does not exceed 

0.02 mSv [2 mrem] in any one hour and the dose to an individual member of the public does not 

exceed 1 mSv [100 mrem] in a year. Use the concepts of time, distance, and shielding when 

choosing storage and use locations. Decreasing the time spent near an irradiator, increasing 

the distance from the irradiator, and using shielding (i.e., brick, concrete, lead, or other solid 

walls) will reduce the radiation exposure. Licensees must determine the radiation levels in 

unrestricted areas that are normally occupied during operation of an irradiator, as specified in 

Table 8-6.

Table 8-6. Radiation Limits Specified in 10 CFR 36.25

Irradiator Type Limit Where Measured Source Position

Panoramic 0.02 mSv 

[2 mrem] per hour

30 cm or more from 

the wall (of the room 

where the sources are 

exposed) in areas 

normally occupied

Exposed

Pool irradiator 

(including panoramic 

pool irradiators and 

underwater 

irradiators)

0.02 mSv 

[2 mrem] per hour

30 cm over the edge 

of the pool of a pool 

irradiator

Shielded

Dry-source-storage 

panoramic irradiator

0.02 mSv 

[2 mrem] per hour

1 m from the shield Shielded

Dry-source-storage 

panoramic irradiator

0.2 mSv 

[20 mrem] per hour

5 cm from the shield Shielded

Doses adjacent to the irradiator location can be determined by direct measurements and 

calculations using the “inverse distance” law to evaluate the effect of distance on radiation levels 

and occupancy factors to account for the actual presence of the member of the public.

If, after making an initial evaluation, a licensee changes the conditions used for the evaluation 

(e.g., changes the shielding of the irradiator, increases the source strength, changes the type or 

frequency of irradiator use, or changes the occupancy of adjacent areas), then the licensee 

must perform a new evaluation to ensure that the public dose limits are not exceeded and take 

corrective action, as needed.

During NRC inspections, licensees must be able to provide documentation demonstrating, by 

measurement or a combination of measurement and calculation, that the total effective dose 

equivalent to the individual likely to receive the highest dose from the licensed operation does 

not exceed the annual limit for members of the public. See Appendix L of this NUREG for 

examples of methods to demonstrate compliance.

Response from Applicant: The applicant’s program to control doses received by individual 

members of the public will be examined during inspection, but should not be submitted in a 

license application.
8-47

8.10.6 Operating Procedures

Regulations: 10 CFR 19.11(a)(3), 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 

10 CFR 20.2201-2207, 10 CFR 21.21, 10 CFR 30.50, 10 CFR 36.13(c), 10 CFR 36.23(h), 

10 CFR 36.51, 10 CFR 36.53, 10 CFR 36.61, 10 CFR 36.65, 10 CFR 36.67, 10 CFR 37.21, 

10 CFR 37.43, 10 CFR 37.45, 10 CFR 37.49

Criteria: The applicant must have and follow written operating procedures for items listed in 

10 CFR 36.53(a). Refer to Table 8-7 for a description of the items.

Licensees that possess an aggregated Category 1 or Category 2 quantity of radioactive material 

must also establish, implement, and maintain an access authorization program; be able to 

monitor and immediately detect, assess, and respond to any actual or attempted unauthorized 

entries into security zones or actual or attempted theft, sabotage, or diversion of radioactive 

material; and coordinate, to the extent practicable, with local law enforcement authorities, for 

responding to threats to the licensee’s facility.

Discussion: Operating procedures must be developed, maintained, and implemented to 

ensure that irradiators are used only as they were designed to be used, and radiation doses 

received by occupational workers and members of the public are ALARA. Copies of operating 

procedures should be provided to all irradiator operators. In addition, the applicant must post 

current copies of operating procedures applicable to licensed activities at each site. If posting of 

procedures is not practicable, the licensee may post a notice that describes the documents and 

states where they may be examined.

NOTE: Radiation dose rates in the radiation room of a panoramic irradiator room will exceed 

500 rad [5 Gray] per hour when the sources are exposed. Therefore, the radiation room should 

be posted as a very high radiation area, in accordance with 10 CFR 20.1902. Also note that 

the signs may be removed, covered, or otherwise made inoperative when the sources are 

fully shielded.

Improper operation could lead to the damage or malfunction of an irradiator and potentially 

lethal radiation overexposures to individuals. The applicant will provide summaries of the 

written operating procedures describing their important radiation safety aspects. The level of 

detail should be sufficient to demonstrate that regulatory requirements have been addressed.

Table 8-7 lists the procedures that must be developed, maintained, and implemented, as well as 

important radiation safety aspects that should be submitted in the application.
8-48

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

Category 2 quantity of radioactive material must, 

• In accordance with 10 CFR 37.21(a), establish, implement, and maintain its access 

authorization program in accordance with the requirements of 10 CFR 37, Subpart B.

• In accordance with 10 CFR 37.43(a), develop a written security plan specific to its 

facilities and operations.

• In accordance with 10 CFR 37.43(b), develop and maintain written procedures that 

document how the requirements of 10 CFR Part 37, Subpart C, and the security plan 

will be met.

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.

Table 8-7. Operating Procedures

Required Procedures Items to be Addressed in Procedures Summary

Operation of the irradiator, 

including entering and leaving the 

radiation room of a panoramic 

irradiator

Description of the operation of the irradiator. 

[For panoramic irradiators, the procedure summary should 

be detailed enough to show how the licensee will comply 

with 10 CFR 36.67, “Entering and leaving the radiation 

room,” and should describe the initial entry and survey 

procedures after an irradiation to demonstrate that the 

source has fully returned to its shielded position.] 

Describe how the applicant will prevent access to keys by 

individuals who have not been qualified to be operators, 

as required by 10 CFR 36.51(a). 

The summary should address the required presence 

(10 CFR 36.65, “Attendance during operation”) of an 

irradiator operator and another person who is trained on 

how to respond and prepared to render or summon 

assistance if the access alarm sounds when product 

movement is occurring. 

Note: At a panoramic irradiator at which static irradiations

(no movement of product) are occurring, a person who is 

trained to respond to alarms described in 36.51(g) must 

be onsite
8-49

Table 8-7. Operating Procedures

Required Procedures Items to be Addressed in Procedures Summary

Use of personnel dosimeters See Section 8.10.4, “Radiation Safety Program—

Occupational Dosimetry”

Surveying the shielding of 

panoramic irradiators

See Section 8.9.3, “Facilities and Equipment—Shielding”

and “Construction Monitoring and Acceptance Testing,” 

Appendix H

Monitoring pool water for 

contamination while the water is in 

the pool and before release of 

pool water to unrestricted areas

See Section 8.9.5, “Facilities and Equipment—Radiation 

Monitors” and Section 8.10.9 “Radiation Safety Program—

Leak Tests”

Leak testing of sources See “Model Leak Test Program for Dry-Source-Storage 

Irradiator Sealed Sources,” Appendix M

Inspection and maintenance 

checks required by 10 CFR 36.61, 

“Inspection and maintenance”

See Section 8.10.10, “Radiation Safety Program—

Inspection and Maintenance Checks”

Loading, unloading, and 

repositioning sources, if the 

operations will be performed by 

the licensee

If these procedures will be performed by the applicant, 

see Appendix G.

Inspection of movable shielding 

required by 10 CFR 36.23(h), if 

applicable.*

Describe inspection of roof plugs or other movable 

shielding required by 10 CFR 36.23(h), if applicable.†

*In 10 CFR 36.65, the term “onsite” is intended to give flexibility to licensees. For example, for a research irradiator 

at a university, the person onsite could be a guard located on campus but not in the building containing the 

irradiator, provided the guard would hear the alarm and was trained as required by 10 CFR 36.51(g). The guard 

would not have to be trained as an irradiator operator.

†If the radiation room of a panoramic irradiator has roof plugs or other movable shielding, it must not be possible to 

operate the irradiator unless the shielding is in its proper location. This requirement may be met by interlocks that 

prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding 

before operating.

Normally, the manufacturer or a person specifically authorized by the NRC or an Agreement 

State will perform nonroutine operations involving source loading, unloading and repositioning, 

troubleshooting the control console, clearing stuck source racks, investigating and remediating 

removable contamination or leaking sources, (re)installing source cables, and other critical 

operations that require special skills or that have the potential for radiation overexposures. If 

these operations are not performed properly with attention to good radiation safety principles, 

the irradiator may not operate as designed, and personnel performing the operations could 

receive potentially lethal exposures. If the applicant wishes to perform nonroutine operations, 

the information in Appendix G should be provided.

Repair and Preventive Maintenance

Applicants are not required to submit outlines of maintenance, service, and repair procedures 

with a license application. However, routine preventive maintenance and repairs should be 

done according to the manufacturer’s written instructions, where applicable, by qualified 

licensee personnel using their knowledge, experience, judgment, and skills to respond to each 

particular situation.
8-50

Improper repairs or maintenance not being performed in a timely fashion have been identified 

as a contributing cause of many incidents. Therefore, malfunctions and defects found during 

inspection and maintenance checks must be repaired without undue delay. It is understood that 

it may be necessary to obtain a special part, piece of equipment, or particular skilled type of 

labor that may not be readily available. Licensees are allowed some flexibility in making 

noncritical repairs. As long as a reasonable effort is made, the licensee will meet the intent of 

the requirement. However, some repairs are critical and not subject to the latitude in 

10 CFR 36.61(b). For example, licensees must make repairs to the access control system 

before operating the irradiator to ensure compliance with 10 CFR 36.23. An administrative 

procedure cannot be substituted for established engineering controls, such as interlocks. 

Preventive maintenance should be performed according to the manufacturer’s written 

instructions. If the manufacturer’s written instructions are not available, the applicant should 

perform a review of the systems comprising the irradiator in consultation with knowledgeable 

individuals, and determine and implement an appropriate schedule for preventive maintenance.

Security of Licensed Material

Security of NRC-licensed materials is a priority of the NRC. A licensee that fails to comply with 

applicable security requirements may be subject to enforcement action. Although it is generally 

difficult to access sealed sources used in most 10 CFR Part 36 irradiators, the applicant should 

develop, maintain, and implement procedures to prevent unauthorized access, removal, or use 

of the licensed material. Also, procedures should require that all areas associated with 

irradiator operations, particularly control and interlock systems, be locked and secured against 

unauthorized access.

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 must 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.

See Section 8.10.13, “Security Program,” for more information about an irradiator security 

program. For additional guidance on implementing 10 CFR Part 37 requirements, see 

NUREG–2155, “Implementation Guidance for 10 CFR Part 37, ‘Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material.’” Additional information 

regarding best practices for protection of risk-significant radioactive material is available in 

NUREG-2166, “Physical Security Best Practices for the Protection of Risk-Significant 

Radioactive Material.”

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

be subject to review and inspection.
8-51

Revision of Procedures

The licensee may revise operating procedures without NRC approval only if all of the following 

conditions are met:

• The revisions do not reduce the safety of the facility.

• The revisions are consistent with the procedure summary submitted with the 

license application.

• The revisions have been reviewed and approved by the RSO.

• The users or operators are instructed and tested on the revised procedures before they 

are put into use.

Response from Applicant:

For routine operations: Provide operating procedure summaries describing the radiation 

safety aspects for those items listed in Table 8-7. For items in which other sections of this guide 

are referenced, respond to the applicable section.

For nonroutine operations: Submit either of the following:

• A statement that: “The irradiator manufacturer or other person authorized by the NRC or 

an Agreement State will perform nonroutine operations, such as source loading, 

unloading and repositioning, electrical troubleshooting of the control console, clearing 

stuck source racks, investigating and remediating removable contamination or leaking 

sources, (re)installing source cables, and other critical operations requiring special skills 

or having the potential for radiation overexposures.”

OR

• The information listed in Appendix G supporting a request to perform this work 

“in-house”

Note: Information requested in Appendix G will be reviewed on a case-by-case basis; if 

approved, the license will contain a condition authorizing the licensee to perform 

nonroutine operations.

Reference: See IN 83-09: “Safety and Security of Irradiators,” dated March 9, 1983, and 

IN 04-18, “Recent Safety-Related Event at Panoramic Wet-Source-Storage Irradiator,” 

dated October 26, 2004.

8.10.7 Procedure for Identifying and Reporting Defects and Noncompliance as 

Required by 10 CFR Part 21

Regulations: 10 CFR Part 21, 10 CFR 30.50, 10 CFR 36.83

Criteria: Licensees must notify NRC if defects and failures are found in a basic component that 

could create a substantial safety hazard.
8-52

Discussion: Equipment defects that could create a substantial safety hazard, or equipment 

failures involving NRC-regulated activities must be reported to the NRC (e.g., failure of an 

access control system such that a person could enter the radiation room during a time when the 

sources are exposed in a panoramic irradiator, or a defect in an interlock that prevents the 

operation of a panoramic irradiator in the event that a roof plug or other movable shielding is not 

in place). Operating personnel should be instructed to report any malfunction or defect in 

irradiator equipment to management so that management can take appropriate action and make 

the required notifications to the NRC.

Response from the Applicant: None required.

8.10.8 Emergency Procedures

Regulations: 10 CFR 19.11(a)(3), 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 

10 CFR 20.2201-2207, 10 CFR 21.21, 10 CFR 30.34, 10 CFR 30.50, 10 CFR 36.13(c), 

10 CFR 36.37, 10 CFR 36.53, 10 CFR 36.59(c), 10 CFR 36.67, 10 CFR 36.83, 10 CFR 37.45, 

10 CFR 37.49, 10 CFR 37.57

Criteria: The licensee must have and follow emergency or abnormal event procedures 

appropriate for items listed in 10 CFR 36.53(b). Emergency procedures should include notifying 

the NRC during and after emergencies and abnormal events.

Discussion: Emergency or abnormal event procedures must be developed, maintained, and 

implemented to ensure that radiation doses received by occupational workers and members of 

the public during emergencies or abnormal events are ALARA. Copies of emergency

procedures should be provided to all irradiator operators. In addition, the applicant must post 

current copies of emergency procedures applicable to licensed activities at each site. If posting 

of procedures is not practicable, the licensee may post a notice that describes the documents 

and states where they may be examined. 

In accordance with 10 CFR 36.13(c), the applicant must provide an outline of written emergency

procedures describing important radiation safety aspects. The level of detail should be 

sufficient to demonstrate that regulatory requirements have been addressed.

Figure 8-8 illustrates proper handling of one type of incident (e.g., broken source rack cable).
8-53

Figure 8-8. Proper Handling of an Incident

Licensee personnel implement emergency procedures when a source rack 

cable breaks.

Licensees must have and follow emergency or abnormal event procedures, appropriate for the 

irradiator type, for:

• sources stuck in the unshielded position

• personnel overexposures

• a radiation alarm from the product exit portal monitor or pool monitor

• detection of leaking sources, pool contamination, or alarm caused by contamination of 

pool water (include 10 CFR 36.59(c) requirements)

• a low or high water level indicator, an abnormal water loss, or leakage from the source 

storage pool and provisions to replenish significant water loss from a position external to 

the radiation room

• a prolonged loss of electrical power (include 10 CFR 36.37, “Power failures,” and 

10 CFR 36.67(c) requirements)
8-54

• a fire alarm or explosion in the radiation room

• an alarm indicating unauthorized entry into the radiation room, area around pool, or 

another alarmed area

• natural phenomena, including an earthquake, a tornado, flooding, or other phenomena 

as appropriate for the geographical location of the facility

• the jamming of automatic conveyor systems

The applicant should consider other events that may require emergency or abnormal event 

procedures (e.g., abnormally high radiation levels indicated by the area radiation monitor, 

collision with the source(s) or source rack).

Emergency and abnormal event procedures should include who will be notified of the event, the 

role of the RSO, and what records of the event will be kept. The procedures should clearly 

identify telephone numbers of the RSO or other individuals who can provide assistance,

including the irradiator manufacturer (or distributor) and State and local agencies. The 

procedures should include actions to be taken immediately after discovering the emergency or 

abnormal event. Emergency procedures should also include notifying the NRC when events 

specified in Table 8-8 shown below occur. Licensees that possess an aggregated Category 1 

or Category 2 quantity of radioactive material must be able to monitor and immediately detect,

assess, and respond to any actual or attempted unauthorized entries into security zones and

coordinate, to the extent practicable, with local law enforcement authorities for responding to 

threats to the licensee’s facility.

The RSO should be proactive in evaluating whether NRC notification is required. Refer to 

Table 8-8 shown below and the regulations 10 CFR 20.2201-20.2207, 10 CFR 30.50,

10 CFR 36.83, 10 CFR 37.57, and 10 CFR 37.81 for descriptions of when and where 

notifications are required.

The following list of notification and reporting requirements is provided to inform licensees about 

typical notification and reporting requirements that apply to their licensed activities. Licensees 

should note that the list is incomplete in that not all potentially applicable requirements have 

been included. Also, notification and reporting requirements change; therefore, licensees 

should consult the regulations for definitive information about current requirements.

Table 8-8. Typical NRC Incident Notifications Required for Irradiator Licensees

Event

Telephone 

Report Written Report

Regulatory 

Requirement

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 rems] 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 rads] per event

Immediate 30 days 10 CFR 20.2202(a)(1)(iii)

10 CFR 20.2203(a)(1)
8-55

Table 8-8. Typical NRC Incident Notifications Required for Irradiator Licensees

(Continued)

Event

Telephone 

Report Written Report

Regulatory 

Requirement

Whole body dose greater than 

0.05 Sv [5 rems] in 24 hours

24 hours 30 days 10 CFR 20.2202(a)(2)

10 CFR 20.2202(b)(1)(i)

10 CFR 20.2203(a)(1)

Extremity dose greater than 0.5 

Sv [50 rems] in 24 hours

24 hours 30 days 10 CFR 20.2202(b)(1)(iii)

10 CFR 20.2203(a)(1)

Whole body dose greater than 

0.05 Sv [5 rems]

None 30 days 10 CFR 20.2203(a)(2)(i), 

(ii) & (iii)

Dose to individual member of 

public greater than 1 mSv [0.1 

rem]

None 30 days 10 CFR 20.2203(a)(2)(iv)

Defect in equipment that could 

create a substantial safety 

hazard

2 days 30 days 10 CFR 21.21(d)(3)(i) 

& (ii)

Filing petition for bankruptcy 

under Title 11 of the 

United States Code

None Immediately 

after filing 

petition

10 CFR 30.34(h)

Expiration of license None 60 days 10 CFR 30.36(d)(1)

Decision to permanently cease 

licensed activities at entire site

None 60 days 10 CFR 30.36(d)(2)

Decision to permanently cease 

licensed activities in any 

separate building or outdoor 

area that is unsuitable for 

release for unrestricted use

None 60 days 10 CFR 30.36(d)(2)

No principal activities 

conducted for 24 months at the 

entire site

None 60 days 10 CFR 30.36(d)(3)

No principal activities 

conducted for 24 months in any 

separate building or outdoor 

area that is unsuitable for 

release for unrestricted use

None 60 days 10 CFR 30.36(d)(4)

Event that prevents immediate 

protective actions necessary to 

avoid exposure to radioactive 

materials that could exceed 

regulatory limits

Immediate. No 

later than 4 

hours after 

event

30 days 10 CFR 30.50(a) & (c)(2)
8-56

Table 8-8. Typical NRC Incident Notifications Required for Irradiator Licensees

(Continued)

Event

Telephone 

Report Written Report

Regulatory 

Requirement

Unplanned contamination event 

that (1) requires restricted 

access for more than 24 hours, 

(2) 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 (3) 

requires the area to be 

restricted for a reason other 

than to allow radionuclides with 

a half-life less than 24 hours to 

decay prior to decontamination.

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

(c)(1) & (c)(2)

Equipment is disabled or fails 

to function as designed when 

required to prevent radiation 

exposure in excess of 

regulatory limits 

24 hours 30 days 10 CFR 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

24 hours 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)
8-57

Table 8-8. Typical NRC Incident Notifications Required for Irradiator Licensees

(Continued)

Event

Telephone 

Report 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) 
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Table 8-8. Typical NRC Incident Notifications Required for Irradiator Licensees

(Continued)

Event

Telephone 

Report 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

Upon 

discovery, as 

soon as 

possible. 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)
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Table 8-8. Typical NRC Incident Notifications Required for Irradiator Licensees

(Continued)

Event

Telephone 

Report 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. The Center is staffed 24 hours a day and accepts collect calls.

Emergency procedures generally should not include post-emergency corrective actions and 

repairs, because there will be time to carefully consider such actions on a case-by-case basis 

after the situation is under control. 

Emergency procedures for personnel overexposures, fire alarms, explosions in the radiation 

room, and natural phenomena may involve emergency responders outside the applicant’s 

organization. The applicant should inform and train individuals in these organizations 

regarding the unique concerns and hazards associated with emergencies at the irradiator 

facility. For instance, hospitals should be informed about the different radiation accidents that 

could occur at the facility (i.e., overexposure vs. personnel contamination incident).

The licensee may revise emergency procedures without NRC approval only if all of the following 

conditions are met:

• The revisions do not reduce the safety of the facility.

• The revisions are consistent with the procedures submitted with the license application.

• The revisions have been reviewed and approved by the RSO.

• The users or operators are instructed and tested on the revised procedures before they 

are put into use.
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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.

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 emergency procedures or summaries, including a 

description of the radiation safety aspects of those items listed in 10 CFR 36.53(b).

8.10.9 Leak Tests

Regulations: 10 CFR Part 20, Appendix B, 10 CFR 30.50, 10 CFR 36.59, 10 CFR 36.81(h), 

10 CFR 36.83

Criteria: The NRC requires testing to determine whether there is any radioactive leakage from 

the sources in the irradiator. Licensees must maintain records of leak test results in accordance 

with license conditions or, if applicable, NRC regulations.

Discussion:

Dry-Source-Storage Sealed Sources

Each dry-source-storage sealed source must be tested for leakage at 6-month intervals. In 

accordance with 10 CFR 36.59(a), sources are prohibited from being used unless the licensee 

tests the sources for leaks or has a certificate from a transferor that leak tests have been 

performed within 6 months before the transfer.

The measurement of the leak test sample is a quantitative analysis requiring that 

instrumentation used to analyze the sample be capable of detecting 200 becquerels

[0.005 microcurie]

3 of radioactivity and must be performed by a person approved by the NRC or 

an Agreement State to perform the analysis. In general, the sensitivity required can be obtained 

with a thin-window G-M probe.

Manufacturers, distributors, consultants, and other organizations may be authorized by the NRC 

or an Agreement State to either perform the entire leak test sequence (sample collection and 

 

310 CFR Part 36 uses one significant figure in converting becquerels to microcurie. 
8-61

analysis) on behalf of licensees or provide leak test kits (sample collection kit) to dry-sourcestorage licensees. In the latter case, the licensee is expected to take the leak test sample 

according to the irradiator manufacturer’s (or distributor’s) and the kit supplier’s instructions. The 

licensee returns the sample to the leak test service provider for evaluation and reporting results. 

Leak test samples should be collected at the most accessible area where contamination would 

accumulate if the sealed source were leaking. See Figure 8-9 below. The NRC or an 

Agreement State may, in a license condition, specifically authorize irradiator licensees to 

conduct the entire leak test sequence themselves. Appendix M of this NUREG contains a 

model leak test program.

Figure 8-9. Leak Testing

The panel on the far left illustrates leak testing a dry-source-storage irradiator 

source, while the other two panels illustrate two ways of monitoring pool water 

to determine if wet-source-storage sources are leaking.

Pool Irradiators

For pool irradiators, 10 CFR 36.59(b) prohibits sources from being put into the pool unless the 

licensee tests the sources for leaks or has a certificate from a transferor that leak tests have 

been performed within 6 months before the transfer. After placing sources in the pool, the water 

must be checked for contamination each day the irradiator operates. For pool irradiators, leak 

testing sources by wipe testing is not highly sensitive or effective. The check may be done 

either by using a radiation monitor on a pool water circulating system or by analyzing a sample 

of pool water. If analyzing a sample of pool water, the results must be available within 24 hours. 

Whether the applicant desires to check for contamination by analyzing a pool water sample 

daily or by continuous monitoring, the procedures and sensitivity of the equipment to be used 

should be detailed in the application. If collecting a pool sample, applicants should use a 

sensitive detector, such as a sodium iodide detector, to verify the absence of detectable 

contamination in the sample. If using the continuous monitoring method, applicants may use a 

less sensitive detector such as a G-M detector affixed to a filter or demineralizer where 

radioactive material would be concentrated.

If the licensee detects a leaking source, the licensee must promptly check personnel, 

equipment, facilities, and irradiated products for contamination. If any personnel or product are 

found to be contaminated, decontamination must be performed immediately. If a source is 

found to be leaking, the licensee must arrange to remove the leaking source from service and 

have it decontaminated, repaired, or disposed of by an NRC or Agreement State licensee that is 
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authorized to perform these functions. If the pool is contaminated, the licensee must arrange to 

clean the pool until the concentration levels do not exceed the appropriate concentration in 

Table 2, Column 2, Appendix B, “Annual Limits on Intake (ALIs) and Derived Air Concentrations 

(DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations 

for Release to Sewerage,” to 10 CFR Part 20. See 10 CFR 30.50 for reporting requirements.

Upon detection of leaking sources, licensees should consider immediately stopping irradiator 

operations to minimize the spread of contamination. In addition, the licensee must make a 

telephone report within 24 hours, as described in 10 CFR 30.50(c)(1), followed by a written 

report within 30 days, as described in 10 CFR 30.50(c)(2).

Response from Applicant:

For dry-source-storage irradiators: Submit one of the following three alternatives:

• A statement that: “Leak tests will be performed at intervals not to exceed 6 months. 

Leak tests will be performed by a service provider authorized by NRC or an Agreement 

State to provide leak testing services to other licensees. Leak tests may be collected by 

the licensee using the instructions from the irradiator manufacturer (or distributor) and

the leak test kit supplier. Such leak test kits will be supplied by an organization 

authorized by the NRC or an Agreement State, to provide leak testing services. Records 

of leak test results not a part of decommissioning recordkeeping requirements will be 

maintained for 3 years from the date of each test.”

OR

• A statement that: “We will implement the model leak test program published in 

Appendix M of NUREG–1556, Volume 6, Revision 1, ‘Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 

Irradiator Licenses.”

OR

• A description of alternative equipment and procedures for determining whether there is 

any radioactive leakage from sources contained in the irradiator.

For pool irradiators: Submit either of the following:

• a description of equipment, procedures, and sensitivity of method that will be used to 

check for contamination by analysis of a sample of pool water

OR

• a description of equipment, procedures, and sensitivity of method that will be used to 

check for contamination by continuous monitoring

Note: Requests for authorization to perform leak testing and sample analysis will be reviewed 

and, if approved, NRC staff will authorize these requests via a license condition.
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8.10.10 Inspection and Maintenance Checks

Regulations: 10 CFR 20.1101, 10 CFR 36.13(c) and (h), 10 CFR 36.53(a)(6), 10 CFR 36.61

Criteria: The applicant must have and follow written procedures for inspection and 

maintenance checks for items specified in 10 CFR 36.61.

Discussion: Applicants must periodically make inspection and maintenance checks to ensure 

proper operation of the irradiator. The frequency of checks is not stated in the regulations,

because it will be site-specific, depending on the design of the facility. However, the frequency 

of checks must be specified in the application. The applicant’s description of the procedures

should specify the frequency of applicable inspection and maintenance checks for the 

following items:

• operability of each aspect of the access control system required by 10 CFR 36.23

• functioning of the source position indicator as required by 10 CFR 36.31(b)

• operability of the radiation monitor for radioactive contamination in pool water required 

by 10 CFR 36.59(b) using a radiation check source, if applicable

• operability of the over-pool radiation monitor at underwater irradiators as required by 

10 CFR 36.29(b)

• operability of the product exit monitor required by 10 CFR 36.29(a)

• operability of the emergency source return control required by 10 CFR 36.31(c)

• leak-tightness of systems through which pool water circulates (visual inspection)

• operability of the heat and smoke detectors and extinguisher system required by 

10 CFR 36.27 (but without turning extinguishers on)

• operability of the means of pool water replenishment required by 10 CFR 36.33(c)

• operability of the indicators of high and low pool water levels required by 

10 CFR 36.33(d)

• operability of the intrusion alarm required by 10 CFR 36.23(i), if applicable

• functioning and wear of the system, mechanisms, and cables used to raise and 

lower sources

• condition of the barrier to prevent products from hitting the sources or source 

mechanism as required by 10 CFR 36.35

• amount of water added to the pool to determine whether the pool is leaking

• electrical wiring on required safety systems for radiation damage

• pool water conductivity measurements as required by 10 CFR 36.63
8-64

The applicant should keep in mind that these are the minimum items to be checked, based on 

requirements in 10 CFR 36.61, and that the licensee should develop and implement procedures 

for other necessary checks as appropriate (e.g., as recommended by the manufacturer). For 

instance, if applicable, the applicant should have and follow written procedures for inspection 

and maintenance checks to ensure that all product positioning system components, product 

boxes, or carriers continue to meet design specifications and are not likely to cause an 

irradiator malfunction.

Response from Applicant: Describe inspection and maintenance checks, including the 

frequency of the checks, listed in the “Discussion” section.

8.10.11 Transportation

Regulations: 10 CFR 20.1101, 10 CFR 30.41, 10 CFR 30.51, Subpart D of 10 CFR Part 37, 

10 CFR 71.5, 10 CFR 71.17, 10 CFR 71.19, 10 CFR 71.21, 10 CFR 71.37, Subpart H of 

10 CFR Part 71, 49 CFR Parts 171-178

Criteria: Applicants 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: The general licenses in 10 CFR 71.17, “General license: NRC-approved 

package,” and 10 CFR 71.21, “General license: Use of foreign approved package,” provide the 

authorizations used by most licensees to transport, or offer for transport, packages of 

radioactive material subject to certain conditions. Regulations in 10 CFR 71.17 contain the 

general license provisions for NRC-approved packages. Transporting licensed materials 

originating at irradiator facilities normally involves quantities of radioactive material that require a 

Type B package. Because of the special requirements involved in shipping Type B packages, 

most irradiator licensees have chosen to transfer possession of radioactive materials to an 

irradiator manufacturer (or service provider licensee) with an NRC or Agreement State license 

that then acts as the shipper. The manufacturer (or service provider licensee) subject to the 

provisions of 10 CFR 71.17 or 10 CFR 71.21, as appropriate, then becomes responsible for 

proper packaging of the radioactive materials and compliance with NRC and DOT regulations. 

Licensees that do this must ensure that the manufacturer (or service provider licensee):

• is authorized to possess the licensed material at temporary jobsites 

(i.e., at the irradiator location)

• actually takes possession of the licensed material under its license

• uses an approved Type B package

• is registered with the NRC as a user of the Type B package

• has an NRC-approved quality assurance (QA) plan

For each shipment, it must be clear who possesses the licensed material and is 

responsible for proper packaging of the radioactive materials and compliance with NRC and 

DOT regulations.
8-65

If a licensee plans to make shipments of licensed materials in Type B packages on its own, the 

licensee must notify the NRC before the first use of an approved package (user registration) and 

have an NRC-approved QA plan as required under the 10 CFR 71.17 general license. For 

information about QA plans, see Revision 3 of Regulatory Guide 7.10, “Establishing Quality 

Assurance Programs for Packaging Used in the Transport of Radioactive Material,”

(issued June 2015). The guide can be found under “Regulatory Guides” on the NRC’s public 

Web site at https://www.nrc.gov/reading-rm/doc-collections/. For further information about 

registering as a user of a package or submitting a QA program for review, contact the NRC’s 

Office of Nuclear Material Safety and Safeguards, Division of Spent Fuel Management by 

calling the NRC’s toll free number, 800-368-5642, extension 415-5824. For information about 

any associated fees, contact the NRC’s Office of the Chief Financial Officer, by calling the 

NRC’s toll free number, 800-368-5642, extension 415-7554.

During an inspection, the NRC uses the provisions of 10 CFR 71.5, “Transportation of licensed 

material,” and a “Memorandum of Understanding with DOT on the Transportation of Radioactive 

Material” (signed June 8, 1979) to examine and enforce various DOT requirements applicable to 

irradiator licensees. The MOU between the NRC and DOT can be found on the NRC public 

Web site at https://www.nrc.gov/about-nrc/regulatory/enforcement/guidance.html. Appendix N

of this NUREG lists major DOT regulations applicable to the shipment and transportation of 

radioactive material.

Licensees shipping or transferring a Category 1 or Category 2 quantity of radioactive material 

are subject to the 10 CFR Part 37, Subpart D (“Physical Protection in Transit”). For additional 

guidance on implementing 10 CFR Part 37 requirements, see NUREG–2155, “Implementation 

Guidance for 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities of 

Radioactive Material.”” Additional information regarding best practices for protection of risksignificant radioactive material is available in NUREG–2166, “Physical Security Best Practices 

for the Protection of Risk-Significant Radioactive Material.”

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

be subject to review and inspection.

Response from Applicant: No response is needed from applicants during the licensing phase. 

However, before making shipments of licensed materials on its own in Type B packages, a 

licensee must ensure that it is in compliance with the general license requirements in 

10 CFR 71.17. Transportation issues will be reviewed during inspection.

References: “Radioactive Material (RAM) Regulations Review 2008” can be found on DOT’s 

Pipeline and Hazardous Materials Safety Administration public Web site at 

https://phmsa.dot.gov/hazmat. 

8.10.12 Minimization of Contamination

Regulations: 10 CFR 20.1406

Criteria: Applicants for new licenses must describe how facility design and procedures for 

operation will minimize, to the extent practicable, contamination of the facility and the 

environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the 

generation of radioactive waste.
8-66

Discussion: All applicants for new licenses need to consider the importance of designing and 

operating their facilities so as to minimize the amount of radioactive contamination generated at 

the site during its operating lifetime and to minimize the generation of radioactive waste during 

decontamination. Irradiator applicants usually do not need to address these issues as a 

separate item, because they are included in responses to other items of the application.

Sealed sources and devices that are approved by the NRC or an Agreement State and located 

and used according to their respective SSD registration certificates usually pose little risk of 

contamination. Leak tests performed as specified in 10 CFR 36.59, “Detection of leaking 

sources,” should identify defective sources. Leaking sources must be withdrawn immediately 

from use and decontaminated, repaired, or disposed of according to NRC requirements. These 

steps minimize the spread of contamination and reduce radioactive waste associated with 

decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs 

using only sealed sources and devices that have not leaked.

Response from Applicant: The applicant does not need to provide a separate response to 

this item because the NRC will consider that the above criteria have been met if the applicant’s 

responses meet the criteria for the following sections: “Radioactive Material—Sealed Sources 

and Devices,” “Facilities and Equipment—Irradiator Pools” (if applicable), “Radiation Safety 

Program–Operating Procedures,” “Radiation Safety Program–Emergency Procedures,”

“Radiation Safety Program—Leak Tests,” and “Waste Management–Sealed Source Transfer 

and Disposal.”

8.10.13 Security Program for Category 1 and Category 2 Radioactive Material

Regulations: 10 CFR Part 37

Criteria: Licensees must ensure the security of Category 1 and Category 2 

radioactive material. 

Note: The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated 

Category 1 or Category 2 quantity of radioactive material. The specific radionuclides subject to 

10 CFR Part 37 requirements are listed in Table 1 of Appendix A to 10 CFR Part 37.

Discussion: 

Requirements in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 Quantities 

of Radioactive Material”

In accordance with 10 CFR Part 37, licensees that possess aggregated Category 1 or 

Category 2 quantities of radioactive material must establish, implement, and maintain an access 

authorization program (Subpart B) and a security program (Subpart C) to ensure physical 

protection of the radioactive material. 

Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37, 

lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

should refer to this table to determine whether its proposed activities would be subject to the 

10 CFR Part 37 requirements.

Before giving individuals unescorted access to Category 1 or Category 2 quantities of 

radioactive material (as defined in 10 CFR 37.5), licensees must conduct background 
8-67

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 must notify the NRC regional office specified in 10 CFR 30.6 in writing at least 

90 days before aggregating radioactive material to a quantity that equals or exceeds the 

Category 2 threshold. Pursuant to 10 CFR 37.43(b), as part of the security program, the 

licensee must develop and maintain written procedures that document how the requirements 

of Subpart C will be met. These written procedures may be subject to NRC review 

and inspection. 

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

NUREG–2155, “Implementation Guidance for 10 CFR Part 37, “Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material.”” Additional information 

regarding best practices for protection of risk-significant radioactive material is available in 

NUREG–2166, “Physical Security Best Practices for the Protection of Risk-Significant 

Radioactive Material.”

Response from Applicant:

No response is required from an applicant or licensee. Compliance with access authorization 

and security program requirements may be reviewed during NRC inspections.

8.11 Item 11: Waste Management

8.11.1 Sealed Source Disposal and Transfer

Regulations: 10 CFR 20.2001; 10 CFR 20.2207; 10 CFR Part 20, Appendices B and E; 

10 CFR 30.41; 10 CFR 30.51; 10 CFR 30.36; 10 CFR 36.59, 10 CFR Part 37 

Criteria: Licensed materials must be disposed of according to NRC requirements by transfer to 

an authorized recipient. Appropriate records must be maintained.

Discussion: When disposing of sealed sources or contaminated items (caused by leaking 

sources), licensees must transfer them to an authorized recipient. Authorized recipients are the 

original manufacturer (or distributor) of the sources, a commercial firm licensed by the NRC or 

an Agreement State to accept radioactive waste from other persons, or another specific 
8-68

licensee authorized to possess the licensed material (i.e., its license specifically authorizes the 

same radionuclide, form, and use).

If a product of the irradiator that may have been inadvertently contaminated has been shipped, 

the licensee must arrange for locating and surveying the product for contamination. If 

contaminated equipment, facilities, or products are found, the licensee must arrange to have 

them decontaminated or properly disposed of by an NRC or Agreement State licensee 

authorized to provide these services. If the pool is contaminated, the licensee must arrange to 

clean the pool until the contamination levels do not exceed the appropriate concentration in 

Table 2, Column 2, Appendix B to 10 CFR Part 20 [10 CFR 36.59(c)].

Before transferring radioactive material, a licensee must verify that the recipient is properly 

authorized to receive it using one of the methods described in 10 CFR 30.41, “Transfer of 

byproduct material.” In addition, all packages containing radioactive sources must be prepared 

and shipped according to NRC and DOT regulations. Furthermore, if source activity exceeds 

activities listed in Appendix E, “Nationally Tracked Source Thresholds,” to 10 CFR Part 20, the 

transfer transaction must be reported in accordance with 10 CFR 20.2207 and verified in 

accordance with 10 CFR Part 37. Records of the transfer must be maintained as required by 

10 CFR 30.51, “Records.” 

Response from Applicant: The applicant does not need to provide a response to this item 

during the licensing process. However, the licensee should establish and include waste 

disposal procedures in its radiation safety program and a decommissioning funding plan and 

cost estimate, if applicable. These issues will be addressed during inspection.

Because of the difficulties and costs associated with disposal of sealed sources, applicants 

should plan their disposal. Applicants may want to consider contractual arrangements with the 

source supplier as part of a purchase agreement.

8.12 Item 12: Fees

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

the fee enclosed with the application.

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

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

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

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

Fees.Resource@nrc.gov.

8.13 Item 13: Certification

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

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

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

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

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

will return all unsigned applications for proper signature.
8-69

Notes:

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

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

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

license and therefore will become binding 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, 

according to Title 10 of the Code of Federal Regulations (10 CFR) 2.109(a) and

10 CFR 30.36(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 C of this NUREG. Training documentation for 

personnel currently listed on the license does not need to be submitted as part of the 

renewal application.

9.1 Timely Notification of Transfer of Control

Regulation: 10 CFR 30.34(b)

Criteria: Licensees must provide all supporting information and obtain the NRC’s prior, written 

consent before transferring control of the license, also referred to as a “change of ownership” or 

“transferring the license.”

Discussion: Transferring control may be the result of mergers, buyouts, or majority stock 

transfers. Although it is not the NRC’s intent to interfere with the business decisions of 

licensees, it is necessary for licensees to obtain prior NRC written consent to ensure 

the following:

• Radioactive materials are possessed, used, or controlled only by persons who have 

valid NRC licenses or Agreement State licenses.

• Materials are properly handled and secured. 

• Persons using these materials are capable, competent, and committed to implementing 

appropriate radiological controls.

• A clear chain of custody is established to identify who is responsible for disposition of 

records and licensed material.

• Public health and safety are not compromised by the use of such materials.
9-2

• Adequate financial assurance is provided for compliance with applicable NRC 

requirements.

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. This RIS can be found on the NRC’s Generic Communications 

Web page under “Regulatory Issue Summaries” at https://www.nrc.gov/reading-rm/doccollections/gen-comm/.
10-1

10 APPLICATIONS FOR EXEMPTIONS

Regulations: 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11, 10 CFR 36.17, 10 CFR 37.11

Criteria: Licensees may request exemptions from U.S. Nuclear Regulatory Commission (NRC)

regulations. The licensee must demonstrate that the exemption is authorized by law, will not 

endanger life, property, or the common defense and security, and is otherwise in the public 

interest. Licensees may also use existing specific exemptions outlined in Title 10 of the Code of 

Federal Regulations (10 CFR) if they meet the established criteria.

Discussion: Various sections of 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 36.17, “Applications for 

exemptions;” and 10 CFR 37.11, “Specific exemptions”). These regulations state that the 

NRC may grant an exemption, acting on its own initiative or on an application from an 

interested person.

Exemptions are not intended to revise regulations or 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.

Until the NRC has granted an exemption in writing, licensees must comply with all applicable 

regulations.

The regulations in 10 CFR 36.17(b) permit teletherapy licensees to propose alternatives to the 

requirements of 10 CFR Part 36, provided there is an adequate rationale and that the 

alternatives provide an adequate level of safety for workers and the public.

For converted teletherapy units, Appendix O lists specific sections of the regulations, the 

rationale and acceptable alternatives, and the wording of the license condition granting the 

exemption. The regions may grant exemption requests shown in Appendix O without consulting 

the Office of Nuclear Material Safety and Safeguards (NMSS).

Exemption requests other than those described in Appendix O must be coordinated 

with NMSS.

11-1

11 TERMINATION OF ACTIVITIES

Regulations: 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

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

• 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

• no principal activities under the license have been conducted for a period of 24 months

• no principal activities have been conducted for a period of 24 months in any separate 

building or outdoor area that contains residual radioactivity such that the building or area 

is unsuitable for release according to NRC requirements

• Submit a decommissioning plan, if required by Title 10 of the Code of Federal 

Regulations (10 CFR) 30.36(g).

• Conduct decommissioning, as required by 10 CFR 30.36(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 

survey, leak test results).

• Before a license is terminated, send records important to decommissioning that are 

required by 10 CFR 30.35(g) to the appropriate NRC regional office in accordance with 

10 CFR 30.51(f).

• 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), 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.

 

1Principal 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

Discussion: To comply with the above criteria, before a licensee can decide whether it must 

notify the NRC under 10 CFR 30.36(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.

For guidance on the disposition of licensed material, see Section 8.11, “Waste Management.”

For guidance on decommissioning records, see Section 8.5.2, “Financial Assurance and 

Recordkeeping for Decommissioning.”

For information about requirements that apply to the timeliness of decommissioning, see 

Regulatory Issue Summary (RIS) 2015-19, Rev. 1, “Decommissioning Timeliness Rule 

Implementation and Associated Regulatory Relief,” dated September 27, 2016, which can be 

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

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

NUREG–1757, “Consolidated Decommissioning Guidance,” contains the current regulatory 

guidance concerning decommissioning of facilities and termination of licenses.

Response from Applicant: The applicant is not required to submit a response to the NRC 

during the initial application. When the license expires or at the time the licensee ceases 

operations, the licensee must undertake necessary decommissioning activities, submit 

NRC Form 314 or equivalent information, and 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

LIST OF NRC INFORMATION NOTICES AND REGULATORY ISSUE

SUMMARIES PERTAINING TO 

PART 36 IRRADIATORS

A–1

List of NRC Information Notices and Regulatory Issue Summaries

Pertaining to Part 36 Irradiators

Information Notices (INs)

IN 83-09 “Safety and Security of Irradiators,” March 9, 1983.

IN 85-01 “Continuous Supervision of Irradiators,” January 10, 1985.

IN 85-36 “Malfunction of a Dry-Storage, Panoramic, Gamma Exposure Irradiator,”

May 9, 1985.

IN 89-25 “Unauthorized Transfer of Ownership or Control of Licensed Activities,”

Rev. 1, December 7, 1994.

IN 89-82 “Recent Safety-Related Incidents at Large Irradiators,”

December 7, 1989.

IN 91-14 “Recent Safety-Related Incidents at Large Irradiators,” March 5, 1991.

IN 94-89 “Equipment Failures at Irradiator Facilities,” December 28, 1994.

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

Corrective Action,” May 1, 1996.

IN 96-54 “Vulnerability of Stainless Steel to Corrosion When Sensitized,”

October 17, 1996.

IN 97-30 “Control of Licensed Material during Reorganizations, EmployeeManagement Disagreements, and Financial Crises,” June 3, 1997.

IN 04-13 “Registration, Use, and Quality Assurance Requirements for 

NRC-Certified Transportation Packages,” June 30, 2004 

IN 04-18 “Recent Safety-Related Event at Panoramic Wet-Source-Storage

Irradiator,” October 26, 2004.

IN 11-11 “Reporting Requirement for Heat and Smoke Detector Failures in 

10 CFR Part 36 Irradiators,” April 27, 2011.

IN 13-22 “Recent Licensing Submittals Containing Personally Identifiable 

Information,” November 15, 2013

Regulatory Issue Summaries (RISs)

RIS 2007-04 “Personally Identifiable Information Submitted to the U.S. Nuclear 

Regulatory Commission,” March 9, 2007

RIS 2014-08 “Regulatory Requirements for Transfer of Control (Change of Ownership) 

of Specific Material Licenses,” Revision 1, May 5, 2016
A–2

RIS 2015-19 “Decommissioning Timeliness Rule Implementation and Associated 

Regulatory Relief, Revision 1,” September 27, 2016

NRC INs and RISs can be found under “Generic Communications” at 

https://www.nrc.gov/reading-rm/doc-collections/.
APPENDIX B

U.S. NUCLEAR REGULATORY COMMISSION FORM 313

B–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 C

SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

ITEMS 5 THROUGH 11 OF U.S. NUCLEAR REGULATORY COMMISSION 

FORM 313

C–1

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item 

No. Title and Criteria Yes

Description 

Attached

5 RADIOACTIVE MATERIAL

Sealed Sources and Devices

• Provide the manufacturer (or distributor) and model 

number of each sealed source to be used in each 

irradiator. For each source model, identify the maximum 

activity per source.

[ ]

• Provide the manufacturer (or distributor) and model 

number of each irradiator to be used. For each irradiator, 

identify the radionuclide, the source model number, 

maximum activity per source, and total possession limit 

being requested. If applicable, identify any depleted 

uranium that is used as shielding (e.g. teletherapy units 

converted to nonhuman use), and specify the total amount 

in kilograms.

[ ]

• Confirm that the proposed sealed source or sealed 

source/irradiator combination (Category II dry-source 

storage) is registered with the NRC or Agreement State 

and will be possessed and used in accordance with the 

conditions specified in the registration certificate. Provide 

the SSD registry number with the application.

[ ]

Financial Assurance and Recordkeeping for 

Decommissioning

• State the Following: “Pursuant to 10 CFR 30.35(g), we 

will maintain records important to decommissioning and 

transfer these records to an NRC or Agreement State 

license, before licensed activities are transferred or 

assigned in accordance with 10 CFR 30.34(b).

Furthermore, pursuant to 10 CFR 30.51(f), prior to license 

termination, we will forward the records required by 

10 CFR 30.35(g) to the appropriate NRC regional office 

before the license is terminated.”

[ ]

AND

• If financial assurance is required, submit evidence of 

financial assurance following the guidance of NUREG–

1757, Volume 3, Revision 1, ‘Consolidated 

Decommissioning Guidance: Financial Assurance, 

Recordkeeping and Timeliness.’

[ ]
C–2

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item 

No. Title and Criteria Yes Description 

Attached

6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL 

BE USED

Provide either of the following:

• A specific description of use for each type of irradiator 

requested, e.g., “For use in irradiation of products or food. 

There will be no irradiation of explosives and no irradiation 

of more than small quantities of flammable materials with a 

flash point below 60° Celsius [140° Fahrenheit] without 

specific written authorization from the NRC.”

[ ]

OR

• If the irradiator will be used for purposes other than 

irradiation of food or products for human use or research 

purposes, a description of these purposes and safety 

analyses (and procedures, if needed) should be provided 

to support safe use.

[ ]

FOR IRRADIATION OF GREATER THAN SMALL 

QUANTITIES OF FLAMMABLE MATERIALS

(evaluated on a case-by-case basis). The following 

portions of this response are N/A if not needed.

If an applicant is applying for authorization to irradiate more 

than a small quantity of flammable material, the application 

should include all of the following information:

[ ]

• name of the flammable material that has a flash point 

below 60°C [140°F] and its flash point

[ ]

• its flammable limit as percent by volume in air [ ]

• its specific gravity as a liquid [ ]

• its vapor density relative to that of air [ ]

• maximum quantity to be in the direct radiation beam in the 

radiation room at any one time

[ ]

• description of the packaging for the product [ ]

In addition, the application should

EITHER

Describe why a single failure is unlikely to cause 

immobilization of the product being irradiated with the 

simultaneous inability to return the sources to the shielded 

position.

[ ]
C–3

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item 

No. Title and Criteria Yes Description 

Attached

6 PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE 

USED (CONTINUED)

OR

Describe why the ventilation system will prevent the 

concentration of vapor in air from exceeding the lower 

flammable limit in a significant volume of the room if the 

product is immobilized and the sources cannot be returned to 

the shielded position. If this second approach is taken, the 

applicant should also provide a procedure to return the source 

to the shielded position, and remove the product from the 

radiation room if the ventilation system fails. The procedure 

should identify the means to detect ventilation system failure.

[ ]

7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM

Radiation Safety Officer (RSO)

Provide the following:

• The name of the proposed RSO, including delegation of 

authority, who will be responsible for ensuring that the 

licensee’s radiation safety program is implemented in 

accordance with approved procedures.

[ ]

AND

• Demonstration that the RSO has sufficient independence 

and direct communication with responsible management 

officials by providing a copy of an organizational chart, by 

position, demonstrating day-to-day oversight and 

coordination with management in radiation safety activities.

[ ]

AND

• The specific training and experience of the RSO. Include 

the specific dates of certification or training, or both, in 

radiation safety.

[ ]

• The name of the proposed RSO, including delegation of 

authority, who will be responsible for ensuring that the 

licensee’s radiation safety program is implemented in 

accordance with approved procedures.

[ ]

AND

• Demonstration that the RSO has sufficient independence 

and direct communication with responsible management 

officials by providing a copy of an organizational chart, by 

position, demonstrating day-to-day oversight and 

coordination with management in radiation safety activities.

[ ]
C–4

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item 

No. Title and Criteria Yes Description 

Attached

7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM (CONTINUED)

Radiation Safety Officer (RSO)

AND

• The specific training and experience of the RSO. Include 

the specific dates of certification or training, or both, in 

radiation safety.

[ ]

• Documentation showing the RSO’s training and 

experience specific to the irradiator that the applicant 

intends to use.

[ ]

• Documentation to show that the RSO has obtained training 

in the regulatory requirements applicable to Part 36 

irradiators.

[ ]

OR

• Alternative information demonstrating that the proposed 

RSO is qualified by training and experience 

(e.g., certification by the American Board of Health 

Physics, completion of a bachelor’s 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).

[ ]

• Documentation to show that the RSO has obtained training 

and experience applicable to the regulatory requirements 

of Part 36 irradiators.

[ ]

8 INDIVIDUALS WORKING IN OR FREQUENTING 

RESTRICTED AREAS

Initial Training for Irradiator Operators

• Provide the statement: “Before using licensed materials, 

irradiator operators will have successfully completed one 

of the training courses described in Criteria in section 8.8.1 

‘Initial Training and Experience for Irradiator Operators’ in 

NUREG-1556, Volume 6, Revision 1, “Consolidated 

Guidance About Materials Licenses: Program-Specific 

Guidance About 10 CFR Part 36 ‘Irradiator Licenses.’”

[ ]

OR

• Provide a description of the initial training program for 

irradiator operators that demonstrates compliance with the 

requirements of 10 CFR 36.51(a), (b), and (c).

[ ]
C–5

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes

Description

Attached

8 INDIVIDUALS WORKING IN OR FREQUENTING 

RESTRICTED AREAS (CONTINUED)

Reviews and Performance Evaluations

Annual Training Regarding Safety Reviews for 

Irradiator Operators

• Describe the program for annual safety reviews and 

performance evaluations of irradiator operators that 

demonstrates compliance with 10 CFR 36.51(d) and (e).

[ ]

Training for Individuals Who Require Unescorted Access

• The applicant’s program for instructing and testing 

unescorted individuals (other than irradiator operators) will 

be examined during inspections, but should not be 

submitted in the license application.

N/A N/A

Training for Individuals Who Must Be Prepared to

Respond to Alarms

The applicant’s program for instructing and testing individuals 

designated to respond to alarms, as applicable, will be 

examined during inspections but should not be submitted in 

the license application.

N/A N/A

9 FACILITIES AND EQUIPMENT

General Description of the Facility and Site

• Describe the irradiator design by including information, 

diagrams, sketches, and photographs, as appropriate.

[ ]

• Show locations of safety-related equipment and features as 

required in 10 CFR Part 36, “Licenses and Radiation Safety 

Requirements for Irradiators.”

[ ]

• Provide a construction schedule for the irradiator, as 

applicable, and updates as necessary.

[ ]

• Describe the site-specific testing frequency of all systems 

listed in 10 CFR 36.61, “Inspection and maintenance.”

[ ]
C–6

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

9 FACILITIES AND EQUIPMENT (CONTINUED)

Access Control

• Submit specific information describing the access control 

system (panoramic irradiators) or personnel access barrier 

(underwater irradiators) and how it works, which 

demonstrates compliance with the requirements of 

10 CFR 36.23. Specific drawings or sketches should be 

submitted, as appropriate. Refer to Appendix O of this 

NUREG regarding exemptions that can be requested for 

teletherapy units converted to nonhuman use.

[ ]

• For panoramic irradiators, describe the facility alarm 

systems.

[ ]

• For panoramic irradiators, describe the lock and key system 

for controlling source movement and discuss how it meets 

the requirements of 10 CFR 36.31(a).

[ ]

• Describe the site-specific testing frequency of access 

control systems (panoramic irradiators) or personnel 

access barrier (underwater irradiators).

[ ]

Shielding for Panoramic Irradiators

• Describe the shielding to be used and its composition. [ ]

• Submit a diagram showing the configuration of shielding, 

including walls and the ceiling, and indicate the thickness of 

each and penetrations in the shielding

[ ]

• If any accessible areas outside the shield are expected to 

have a dose rate exceeding 0.02 millisieverts (mSv) 

[2 millirem (mrem)] per hour, identify the areas and tell how 

access to those areas will be controlled for radiation safety 

purposes.

[ ]

• For irradiators built in seismic areas, describe the design 

requirements for maintaining radiation shield integrity 

during an earthquake, to include geologic and seismic site 

considerations (e.g. technical analysis) undertaken prior to 

construction.

[ ]

• For requests to possess more than 2 × 1017 becquerels 

[5,000,000 curies], submit an evaluation of the effects of 

heating of the shield walls by the irradiator sources (see 

10 CFR 36.39(a).

[ ]

• Describe the site-specific testing frequency of the irradiator 

shielding as required by 10 CFR 36.57, “Radiation 

Surveys.”

[ ]

Note: For underwater irradiators, no response is required 

from the applicant in a license application.

N/A
C–7

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

9 FACILITIES AND EQUIPMENT (CONTINUED)

Fire Protection for Panoramic Irradiators

Describe:

• Type and location of the heat and smoke detectors to be 

used to detect a fire in the radiation room.

[ ]

• Alarms to alert personnel trained to summon assistance [ ]

• How the sources will automatically become fully shielded if 

a fire is detected

[ ]

• How the heat and smoke detectors will be tested and the 

testing frequency.

[ ]

Note: For an underwater irradiator, no response is required 

since the sources are always underwater and not subject to 

damage by fire.

N/A

Radiation Monitors

• Describe the location and type of radiation monitors that will 

be used to meet the requirements of 10 CFR 36.23(c); 

10 CFR 36.29, and 10 CFR 36.59(b).

[ ]

• Describe the location and types of alarms and those 

individuals who are trained to respond to those alarms. 

Use diagrams and sketches, as appropriate.

[ ]

• Discuss the alarm set-points or the methods for 

establishing the alarm set-points.

[ ]

• Describe the evaluation performed to meet 

10 CFR 36.39(e) on detector location and sensitivity and 

the acceptance testing that will be performed to meet 

10 CFR 36.41(e).

[ ]

• Describe the site-specific testing frequency of 

radiation monitors.

[ ]

Irradiator Pools

Describe:

• The water-tight stainless pool liner. If no water-tight 

stainless steel liner or a liner metallurgically compatible with 

other components in the pool is used, explain why the pool 

has a low likelihood of substantial leakage and how 

decontamination could be accomplished, if necessary.

[ ]
C–8

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

9 FACILITIES AND EQUIPMENT (CONTINUED)

Irradiator Pools

• The high and low water-level indicators and their locations. [ ]

• The purification system for the pool and explain why the 

purification system is considered capable of maintaining 

pool water conductivity less than 20 microsiemens per 

centimeter

[ ]

• The means to replenish pool water, including significant 

water losses from a position external to the radiation room 

when necessary.

[ ]

• The barrier used during normal operations to prevent 

personnel from falling into the pool.

[ ]

• How high radiation doses from radiation streaming will be 

avoided when using long-handled tools or poles (use 

sketches if appropriate).

[ ]

• If the pool has outlets more than 0.5 meter below the 

surface that could allow water to drain out of the pool, the 

means of preventing inadvertent excessive loss of pool 

water (in this context outlets do not include transfer tubes 

between adjacent pools because the transfer tubes do not 

provide a means to allow water to drain out of the pools).

[ ]

• Describe the site-specific testing frequency of multiple 

regulatory required systems as listed in 10 CFR 36.61.

[ ]

Source Rack

• Submit procedures for ensuring source rack protection and 

testing frequency of the source rack protection system. If 

the product moves on a product conveyer system, describe 

the source rack protection to be provided to prevent 

products and product carriers from touching the source 

rack or mechanism that moves the rack. Provide diagrams 

or sketches of those systems, if appropriate.

[ ]

Power Failures for Panoramic Irradiators [ ]

• Describe how the sources are automatically returned to the 

shielded position if offsite power is lost for longer than 

10 seconds.

[ ]

• Describe how loss of power will affect the lock on the doors 

in the radiation room.

[ ]
C–9

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes

Description

Attached

9 FACILITIES AND EQUIPMENT (CONTINUED)

Power Failures for Panoramic Irradiators [ ]

• Describe how the access control system will operate 

properly if offsite power is lost. Describe how computer 

security features prevent an irradiator operator from 

commanding the computer to override the access control 

system.

[ ]

• Describe the site-specific testing frequency to ensure that 

sources are returned to the shielded position if offsite 

power is lost for longer than 10 seconds.

[ ]

Note: For underwater irradiators, no response is required 

from the applicant in a license application.

N/A

10 RADIATION SAFETY PROGRAM

Audit and Review of Program

The applicant’s program for reviewing the content and 

implementation of its radiation protection program may be 

examined during inspections but should not be submitted in 

the license application.

Need not be 

submitted with 

application

Survey Instruments

Applicant must provide the following statements:

• “We will use survey instruments that meet the criteria in the 

section entitled ‘Radiation Safety Program – Instruments’ in 

the current version of NUREG–1556, Volume 6, Revision 

1, “Consolidated Guidance About Materials Licenses: 

Program-Specific Guidance About 10 CFR Part 36 

Irradiator Licenses.’”

[ ]

AND ONE OF THE FOLLOWING

• “Each survey meter will be calibrated by the manufacturer 

or other person authorized by the NRC or an Agreement 

State to perform survey meter calibrations.”

[ ]

OR

• “We will implement the model survey meter calibration 

program published in Appendix J “Model Radiation Survey 

Instrument Calibration’ in NUREG–1556, Volume 6, 

Revision 1, ‘Consolidated Guidance About Materials 

Licenses: Program-Specific Guidance About 

10 CFR Part 36 Irradiator Licenses.’”

[ ]

OR
C–10

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

10 RADIATION SAFETY PROGRAM (CONTINUED)

Survey Instruments

• Submit alternative calibration procedures for NRC review. [ ]

Radiation Monitors

• Describe the type of monitors used to meet the 

requirements of 10 CFR 36.23(c); 10 CFR 36.29, and 

10 CFR 36.59(b).

[ ]

Material Receipt and Accountability

• Submit a description of procedure(s) for ensuring 

material accountability.

[ ]

OR

A statement that: “We will develop, implement, and maintain 

procedures for ensuring accountability of licensed materials at 

all times.”

AND

A statement declaring that: “We will comply with the NSTS 

reporting requirements as described in 10 CFR 22.2207.”

[ ]

Occupational Dosimetry

Provide the following:

• A statement that: “Film, TLD, or other dosimetry devices 

are processed and evaluated by an NVLAP-accredited 

processor.”

[ ]

• A statement that: “Film, TLD, or other personnel dosimetry 

devices will be exchanged at the required frequency and 

will be assigned to and worn by irradiator personnel.”

[ ]

• A statement that: “Other individuals, including visitors, 

entering a radiation room will be provided dosimetry in 

accordance with regulatory requirements.”

[ ]

Public Dose

The applicant’s program to control doses received by 

individual members of the public will be examined during 

inspection but should not be submitted in a license 

application.

Need not be 

submitted with 

application
C–11

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

10 RADIATION SAFETY PROGRAM (CONTINUED)

Operating Procedures

Routine Operations

• Provide summaries describing the radiation safety aspects 

of the written operating procedures listed in 

10 CFR 36.53(a). 

[ ]

Nonroutine Operations

Submit either of the following:

• A statement that: “The irradiator manufacturer or other 

person authorized by NRC or an Agreement State will 

perform nonroutine operations such as source loading, 

unloading and repositioning, electrical troubleshooting of 

the control console, clearing stuck source racks, 

investigating and remediating removable contamination or 

leaking sources, (re)installing source cables, and other 

critical operations requiring special skills or having the 

potential for radiation overexposures.”

[ ]

OR

• The information listed in Appendix G in the current version 

of NUREG–1556, Volume 6.

[ ]

Emergency Procedures

Provide emergency procedures or summaries, including a 

description of the radiation safety aspects of those items listed 

in 10 CFR 36.53(b).

[ ]

Leak Tests

For Dry-Source-Storage Irradiators

Provide one of the following three alternatives:

• A statement that: “Leak tests will be performed at intervals 

not to exceed 6 months. Leak tests will be performed by a 

service provider authorized by NRC or an Agreement State 

to provide leak testing services to other licensees. Leak 

tests may be collected by the licensee using instructions 

from the irradiator manufacturer (or distributor) and the 

leak test kit supplier. Such leak test kits will be supplied by 

an organization authorized by the NRC or an Agreement 

State, to provide leak testing services. Records of leak test 

results not a part of decommissioning recordkeeping 

requirements will be maintained for 3 years from the date 

of each test.”

[ ]
C–12

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

10 RADIATION SAFETY PROGRAM (CONTINUED)

For Dry-Source-Storage Irradiators

OR

• A statement that: “We will implement the model leak test 

program published in Appendix M of NUREG–1556, 

Volume 6, Revision 1, ‘Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance About 

10 CFR Part 36 Irradiator Licenses.”

[ ]

OR

• Provide a description of alternative equipment and/or

procedures for determining whether there is any 

radioactive leakage from sources contained in the 

irradiator.

[ ]

Leak Tests

For Pool Irradiators

Submit either of the following:

• a description of equipment, procedures, and sensitivity of 

method that will be used to check for contamination by 

analysis of a sample of pool water

[ ]

OR

• a description of equipment, procedures, and sensitivity of 

method that will be used to check for contamination by 

continuous monitoring

[ ]

Inspection and Maintenance

Describe inspection and maintenance checks, including the 

frequency of the checks, listed in 10 CFR 36.61.

[ ]

Transportation

No response is needed from applicants during the licensing 

phase. However, before making shipments of licensed 

materials on its own in Type B packages, a licensee must 

ensure that it is in compliance with the general license 

requirements in 10 CFR 71.17. Transportation issues will be 

reviewed during inspection.

Need not be 

submitted with 

application
C–13

Suggested Format for Providing Information Requested in Items 5 through 11 of 

U.S. Nuclear Regulatory Commission Form 313

Item

No Title and Criteria Yes Description

Attached

10 RADIATION SAFETY PROGRAM (CONTINUED)

Minimization of Contamination

No response is necessary. The NRC will consider that the 

criteria have been met if the applicant’s responses meet the 

criteria for the following sections: “Radioactive Material -

Sealed Sources and Devices,” “Facilities and Equipment -

Irradiator Pools” (if applicable), “Radiation Safety Program -

Operating Procedures,” “Radiation Safety Program -

Emergency Procedures,” “Radiation Safety Program - Leak 

Tests,” and “Waste Management - Sealed Source Transfer 

and Disposal.”

Need not be 

submitted with 

application

Security Program

No response is necessary. In accordance with 

10 CFR Part 37, licensees that possess an aggregated 

Category 1 or Category 2 quantity of radioactive material must 

establish, implement, and maintain an access authorization 

program and a security program to ensure physical protection 

of the radioactive material.

Need not be 

submitted with 

application

11 WASTE MANAGEMENT

Sealed Source Disposal and Transfer

The applicant does not need to provide a response to this 

item during the licensing process. However, the licensee 

should establish and include waste disposal procedures in its 

radiation safety program and a decommissioning funding plan 

and cost estimate, if applicable. These issues will be 

addressed during inspection.

Need not be 

submitted with 

application

APPENDIX D

IRRADIATION OF EXPLOSIVE MATERIALS OR GREATER THAN SMALL 

QUANTITIES OF FLAMMABLE MATERIALS

D–1

Irradiation of Explosive Materials or Greater Than Small Quantities of 

Flammable Materials

Explosive Materials

Irradiation of explosive materials is prohibited under Title 10 of the Code of Federal Regulations

(10 CFR) 36.69, “Irradiation of explosive or flammable materials,” unless the applicant has 

received prior, written authorization from the U.S. Nuclear Regulatory Commission (NRC). If an 

applicant requests authorization to irradiate explosive materials, he or she must be able to 

demonstrate that detonation of the explosive would not rupture the irradiator sealed sources, 

injure personnel, damage safety systems, or cause radiation overexposure of personnel.

Greater Than Small Quantities of Flammable Materials

Prior written authorization from the NRC is required by 10 CFR 36.69(b) before irradiation of 

more than small quantities of flammable materials with a flash point below 60° Celsius (C) 

[140° Fahrenheit (F)] in a panoramic irradiator. As defined in the National Fire Code NFPA 30, 

“Flammable and Combustible Liquids Code,” published by the National Fire Protection 

Association (NFPA), the flash point is “the minimum temperature at which a liquid gives off 

vapor in sufficient concentration to form an ignitable mixture with air near the surface of the 

liquid...” According to the NFPA 30 classification system, Class I and Class II liquids have flash 

points below 60° C [140° F]. The flash points of many substances are tabulated in NFPA 325, 

“Fire Hazard Properties of Flammable Liquids, Gases, and Volatile Solids.”1

 Flash points are 

also specified on the material safety data sheets for industrial chemicals, when applicable. 

Examples of common flammable liquids with a flash point below 60° C [140° F] are acetone, 

benzene, most alcohols, number two fuel oil, gasoline, kerosene, toluene, turpentine, and any 

flammable gas.

The NRC is concerned about irradiating flammable materials that may cause an explosion. If 

the flash point of a flammable liquid is exceeded, the concentration of the vapor in air could 

exceed the flammable limit, and the potential for an explosion could exist.

The NRC considers that compliance with the requirements in 10 CFR 36.21, 10 CFR 36.27, 

10 CFR 36.35, 10 CFR 36.39(h); 10 CFR 36.41(h); and 10 CFR 36.53(b)(7) will provide 

adequate protection against radiological impacts arising from a fire. With an energetic 

explosion, however, applicants should consider the possibility of direct damage to the source 

encapsulation or to the source rack preventing it from being lowered to the shielded position.

A “small quantity” of flammable material can be defined as a quantity of flammable material that, 

when dispersed evenly throughout the radiation room with no loss to ventilation, would have a 

concentration below the lower flammable limit concentration. Although local concentrations 

could exceed the average room concentration, the movement of air into and out of the radiation 

room provides a margin of safety. In addition, the time required to vaporize all the material also 

adds to the margin of safety. Further, small pockets of flammable vapor will contain quantities 

of energy too small to provide a force strong enough to significantly damage the irradiator. 

 

1Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, Massachusetts 

02169-7471 [Telephone 800-344-3555].
D–2

Given these factors, the definition of small quantity is considered to be conservative enough to 

ensure safe operation of an irradiator.

Special precautions must be taken when irradiating cryogenic material. The hazard from 

cryogenic irradiation occurs when air condenses or freezes (possibly insidiously without 

detection) on cold surfaces during irradiation. While the exact details are uncertain, oxygen in 

the air is converted by the radiation to ozone. Under certain circumstances (often during a 

subsequent warmup), the ozone decomposes or reacts with other agents explosively. If 

cryogenic material is to be irradiated, the applicant must submit procedures for ensuring the 

safe handling of such material.2

Example of Determining a Small Quantity of Flammable Material:

This example considers the irradiation of isopropyl alcohol in a radiation room whose total 

volume is 100 m3

. NFPA 325 states that the lower flammable limit at atmospheric temperature 

and pressure for isopropyl alcohol is 2 percent by volume, the specific gravity of the liquid is 0.8, 

and the vapor density relative to that of air is 2.1. The density of air is 1.293 kilograms (kg) per 

millimeters cubed (m/3) (kg/m3

). The volume of isopropyl alcohol in the room at the lower 

flammable limit will be 2 percent of 100 m3

, which is equal to 2m3. The weight will be 

2m3 × 1.293 kg/m3 × 2.1 (density relative to air) = 5.43 kg. With a specific gravity of 0.8, the 

volume of the liquid isopropyl alcohol would be 6.79 liters. If the liquid mixture were 70 percent 

isopropyl alcohol and 30 percent water, the volume of a small quantity would be 

6.79/0.7 = 9.7 liters. Thus, in a radiation room with a volume of 100 m3

, a volume less than 

9.7 liters of 70 percent isopropyl alcohol (exposed to the direct radiation beam) can be 

considered a small quantity because the flammable limit could not be reached in any significant 

volume, even if there were no ventilation.

If the applicant irradiates small quantities of flammable material, the licensee’s records should 

demonstrate that the above criterion for small quantities has been met, including how the 

licensee limited the quantity of flammable material in the radiation room at one time.

If the quantity to be exposed to the direct beam at any one time would exceed a small quantity, 

it is necessary to consider whether the concentration of flammable vapor in the room air could 

exceed the lower flammable limit. If product movement through the irradiator stopped, and the 

radiation sources could not be returned to the shielded position, the temperature of the 

irradiated product would rise. This could cause the vapor pressure of the flammable material to 

increase, and that pressure might cause the containers to leak and release flammable vapor 

into the room air. If ventilation were insufficient, the flammable vapor concentration might 

exceed the lower flammable limit, and a spark could cause the mixture to explode.

Requests for Approval to Irradiate More Than Small Quantities of Flammable Material:

The applicant must demonstrate that it is unlikely that the concentration of flammable vapor in 

the air in a significant volume of the room would exceed the lower flammable limit. There are 

two methods to do this. The first method requires demonstrating that no single failure would be 

likely to cause the product to become immobilized in the radiation room and prevent the sources 

 

2This information was taken from Oak Ridge National Laboratory Report ORNL/M-260, DE87 002877, “Safety

Analysis Report for the National Low-Temperature Neutron Irradiation Facility (NLTNIF) at the ORNL Bulk Shielding

Reactor (BSR),” June 1986.
D–3

from being returned to the shielded position. Such a situation theoretically might arise if the 

product carriers became jammed and pushed into the source rack preventing its return to the 

shielded position. The second method is to demonstrate that even if the product became 

immobilized and the source rack could not be returned to the shielded position, the ventilation 

system would prevent the concentration of flammable vapor in a significant volume of the room 

air from reaching the lower flammable limit.

APPENDIX E

TRAINING FOR RADIATION SAFETY OFFICERS AND 

IRRADIATOR OPERATORS

E–1

Training for Radiation Safety Officers and Irradiator Operators

Training for Radiation Safety Officer

Course Content

Training for radiation safety officers (RSOs) will be provided by a qualified instructor and may be 

in the form of lecture, video, or self-study emphasizing the following practical subjects important 

to safe use of irradiators:

• Principles of radiation safety

— radioactivity and radioactive decay

— interactions of radiation with matter

— external radiation vs. radioactive contamination

— internal vs. external exposure

— biological effects of radiation (e.g., why large radiation doses must be avoided)

— units of radiation dose

— types and relative hazards of radioactive material possessed

— as low as is reasonably achievable (ALARA) concept

— use of time, distance, and shielding to minimize exposure (e.g., how shielding 

and access controls prevent large doses)

— radiation detection and measurement using survey meters, monitors, and 

personnel dosimeters

• Regulatory requirements

Applicable regulations (i.e., Title 10 of the Code of Federal Regulations (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 30, “Rules of General Applicability to 

Domestic Licensing of Byproduct Material;” and 10 CFR Part 36, “Licenses and Radiation 

Safety Requirements for Irradiators,” and 10 CFR Part 37, “Physical Protection of Category 1 

and Category 2 Quantities of Radioactive Material”

— NRC dose limits

— license conditions, amendments, renewals

— locations of use and storage of radioactive materials

— material control, accountability, and security requirements

— annual audit of radiation safety program
E–2

— recordkeeping requirements

— case histories of accidents or problems involving irradiators

— handling incidents

— recognizing and ensuring that radiation warning signs are visible and legible

— licensing and inspection by regulatory agency

— need for complete and accurate information (10 CFR 30.9, “Completeness and 

accuracy of information”)

— employee protection (10 CFR 30.7)

— deliberate misconduct (10 CFR 30.10)

• Practical explanation of the theory and operation of irradiators

— basic function of the irradiator

— radiation safety features of an irradiator (including alarms)

— operating and emergency procedures listed in 10 CFR 36.53 that the individual is 

responsible for performing

— routine vs. nonroutine maintenance

— lock-out procedures

— how an irradiator is designed to prevent contamination

• On-the-job training for an RSO also should include at least 3 months (full-time 

equivalent) of experience at the applicant’s irradiator or at another irradiator of a similar 

type. The 3 months of experience may include preoperational involvement, such as 

acceptance testing, while the irradiator is being constructed.

Course Examination

• Written examination designed to verify an individual’s competence and understanding of 

the subject matter (e.g., 25 to 50 questions, closed-book written test with 80 percent as 

the passing grade).

Training for Irradiator Operators

Course Content

Training for operators will be provided by a qualified instructor and may be in the form of lecture, 

video, or self-study emphasizing the following practical subjects important to safe use of 

irradiators:
E–3

• Radiation safety

— external radiation versus radioactive contamination

— internal versus external exposure

— biological effects of radiation (e.g., why large radiation doses must be avoided)

— units of radiation dose

— types and relative hazards of radioactive material possessed

— ALARA concept

— use of time, distance, and shielding to minimize exposure (e.g., how shielding 

and access controls prevent large doses)

— proper use of survey meters and personnel dosimeters

• Regulatory requirements

— applicable regulations

— NRC dose limits

— case histories of accidents or problems involving irradiators

— handling incidents

— recognizing and ensuring that radiation warning signs are visible and legible

• Practical explanation of the theory and operation of irradiators

— basic function of the irradiator

— radiation safety features of an irradiator

— operating and emergency procedures listed in 10 CFR 36.53 that the individual is 

responsible for performing

— routine vs. nonroutine maintenance

— lock-out procedures

— how an irradiator is designed to prevent contamination

Before an individual is permitted to operate an irradiator without a supervisor present, in 

accordance with 10 CFR 36.51(c), the individual must have received on-the-job training or 

simulator training in the use of the irradiator, as described in the license application. The 

individual shall also demonstrate the ability to perform those portions of the operating and 

emergency procedures that he or she is to perform. On-the-job or simulator training must be 

completed under the supervision of a qualified irradiator operator:
E–4

• Supervised hands-on experience performing

— operating procedures that the individual is responsible for performing

— test runs of emergency procedures that the individual is responsible 

for performing

— routine maintenance

— lock-out procedures

Course Examination

• Before an individual is permitted to operate an irradiator without a supervisor present, 

the individual shall pass a written test on the instruction received, consisting primarily of 

questions based on the licensee’s operating and emergency procedures that the 

individual is responsible for performing and other operations necessary to safely operate 

the irradiator without supervision. The written examination will be designed to verify an 

individual’s competence and understanding of the stated subject matter (e.g., 25 to 

50 questions, closed-book written test with 80 percent as the passing grade). In 

addition, the licensee shall conduct safety reviews for and evaluate the safety 

performance of each irradiator operator at least annually, and each operator shall be 

given a brief written test.

Training Assessment

Management will ensure that potential RSOs and authorized operators are qualified to work 

independently with irradiators. This must be demonstrated by written examination and by 

direct observations.

Course Instructor Qualifications

Instructors should have either

• bachelor’s degree in a physical or life science or engineering

• successful completion of an irradiator manufacturer’s course for users (or equivalent)

• successful completion of an 8-hour radiation safety course

• 8 hours of hands-on experience with irradiators

OR

• successful completion of an irradiator manufacturer’s course for users (or equivalent) 

• successful completion of 40-hour radiation safety course

• 30 hours of hands-on experience with irradiators.
E–5

Note:

• Licensees must maintain records of training [10 CFR 36.81(b)].

• Additional training is required for those applicants intending to perform nonroutine 

operations, such as source loading and unloading. See Appendix G of this NUREG, 

“Information Needed to Support Applicant’s Request to Perform Nonroutine Operations.”

• Additional security-related training is required in 10 CFR Part 37.

APPENDIX F

TYPICAL DUTIES AND RESPONSIBILITIES OF 

THE RADIATION SAFETY OFFICER

F–1

Typical Duties and Responsibilities of the Radiation Safety Officer

The radiation safety officer’s (RSO’s) duties and responsibilities include ensuring radiological 

safety, security and compliance with both U.S. Nuclear Regulatory Commission (NRC)

regulations and the conditions of the license. Typically, the RSO’s duties and 

responsibilities include

• stopping activities that the RSO considers unsafe

• keeping exposures as low as is reasonably achievable (ALARA)

• developing, maintaining, distributing, and implementing up-to-date operating and 

emergency procedures, as appropriate

• ensuring that individuals associated with irradiator operations are properly trained 

and evaluated

• ensuring that nonroutine operations (See Appendix G of this NUREG) for irradiators are 

consistent with the limitations in the license, the sealed source and device registration 

certificate(s), and the manufacturer’s written recommendations and instructions

• analyzing potential safety consequences of nonroutine operations before conducting any 

such activities that have not been previously analyzed

• ensuring nonroutine operations are performed by the manufacturer or person specifically 

authorized by the NRC or an Agreement State to perform those operations

• ensuring personnel monitoring devices are used and exchanged at the proper intervals, 

and records of the results of such monitoring are maintained by the licensee

• maintaining documentation to ensure that unmonitored individuals are not likely to 

receive, in a year, a radiation dose in excess of 10 percent of the allowable limits or 

provide personnel monitoring devices 

• notifying proper authorities of incidents, such as damage to or malfunction of irradiators, 

fire, loss, or theft of licensed materials

• investigating emergencies and abnormal events involving the irradiators 

(e.g., malfunctions or damage), identifying cause(s), implementing appropriate and 

timely corrective action(s)

• performing radiation safety program audits at least every 12 months and developing, 

implementing, and documenting timely corrective actions

• ensuring transport of licensed material according to all applicable U.S. Department of 

Transportation requirements

• ensuring proper disposal of licensed material

• maintaining appropriate records associated with irradiator operations
F–2

• maintaining an up-to-date license and timely submission of amendment and 

renewal requests

• ensuring that when the licensee identifies violations of regulations or license 

conditions or program weaknesses, corrective actions are developed, implemented, 

and documented

• should be involved in the development and implementation of a security program in 

accordance with 10 CFR Part 37
F–3

Model Delegation of Authority

Memo To:Radiation Safety Officer

From:Chief Executive Officer

Subject:Delegation of Authority

You, _______________________________, have been appointed radiation safety officer and 

are responsible for ensuring the safe and secure use of radiation. You are responsible for 

managing the Radiation 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 G

INFORMATION NEEDED TO SUPPORT APPLICANT’S REQUEST TO 

PERFORM NONROUTINE OPERATIONS

G–1

Information Needed to Support Applicant’s Request to

Perform Nonroutine Operations

Nonroutine operations may include, but are not limited to, the following:

• source loading, unloading, and repositioning

• troubleshooting the control console

• clearing stuck source racks

• investigating and remediating removable contamination and leaking sources

• (re)installing source cables

• any other activity during which personnel could receive radiation doses exceeding 

U.S. Nuclear Regulatory Commission limits

If these operations are not performed properly with attention to radiation safety principles, the 

irradiator may not operate as designed, and personnel performing these tasks could receive 

lethal radiation doses.

Applicants wishing to perform nonroutine operations must use personnel with special training 

and follow appropriate procedures consistent with the manufacturer’s written instructions and 

recommendations that address radiation safety concerns (e.g., use of radiation survey meter, 

personnel dosimetry). Accordingly, provide the following information:

• Describe which nonroutine operations will be performed. 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 

applicable to these operations. Acceptable training would include manufacturers’ 

courses for nonroutine operations or equivalent.

• Submit procedures for nonroutine operations. These procedures should ensure 

the following:

— Doses to personnel and members of the public are within regulatory limits and as 

low as is reasonably achievable (e.g., use of shielding and adequate planning 

when working with unshielded sources).

— Manufacturer’s written instructions and recommendations are followed.

— Planned special exposure requirements (Title 10 of the Code of Federal 

Regulations (10 CFR) 20.1206, “Planned special exposures”), if applicable, are 

met.

• Operations involving source loading, unloading, and repositioning include recording the 

rack position of each source and surveying all empty or loaded source transport 
G–2

containers for removable contamination to prevent the introduction of radioactive 

contaminants into the irradiator.

• Confirm that individuals performing nonroutine operations will wear whole body radiation 

dosimetry, if appropriate.

• Describe steps to be taken to ensure that radiation levels in areas where nonroutine 

operations will take place do not exceed the limits in 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.

— 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, “Records of surveys.”
APPENDIX H

CONSTRUCTION MONITORING AND ACCEPTANCE TESTING

H–1

Construction Monitoring and Acceptance Testing

To ensure that irradiators and their components are built and installed as designed, Title 10 of 

the Code of Federal Regulations (10 CFR) 36.41, “Construction monitoring and source testing,” 

requires that licensees conduct monitoring and acceptance testing before loading sealed 

sources into an irradiator. Figure H–1 illustrates this point, and Table H–1 correlates the 

components to be checked and the types of tests with the type of irradiator to which the 

requirement applies.

Figure H–1. Construction Monitoring and Acceptance Testing

Before loading sealed sources, irradiator licensees must ensure that the asbuilt irradiator meets design criteria.

Table H–1. Construction Monitoring and Acceptance Testing

Irradiator 

Elements Irradiator Type Licensee Requirement

Shielding Panoramic Monitor the construction of the shielding to ensure that 

its construction meets design specifications and 

generally accepted building code requirements for 

reinforced concrete or steel-plated shields.

Foundations Panoramic Monitor the construction of the foundations to verify that 

their construction meets design specifications.

Pool integrity Pool Verify that the pool meets design specifications,

including requirements in 10 CFR 36.33(a) and test the 

integrity of the pool.

Verify that outlets and pipes meet the requirements of 

10 CFR 36.33(b).

Water handling 

system

Pool Verify that the water purification system, the conductivity 

meter, and the water level indicators operate properly 

(water level controls should be checked, if installed).
H–2

Table H–1. Construction Monitoring and Acceptance Testing

Irradiator 

Elements Irradiator Type Licensee Requirement

Radiation 

monitors

All Verify the proper operation of the monitor to detect 

sources carried on the product conveyor system and the 

related alarms and interlocks required by 

10 CFR 36.29(a).

Pool Verify the proper operation of the radiation monitors and 

the related alarm if used to meet 10 CFR 36.59(b).

Underwater Verify the proper operation of the over-the-pool monitor, 

alarms, and interlocks required by 10 CFR 36.29(b).

Source rack Panoramic Test the movement of the source racks for proper 

operation prior to source loading; testing must include 

source rack lowering due to simulated loss of power.

Irradiator with 

product conveyor 

systems

Observe and test the operation of the conveyor system 

to ensure that the requirements in 10 CFR 36.35, 

“Source rack protection,” are met for protection of the 

source rack and the mechanism that moves the rack; 

testing must include tests of any limit switches and 

interlocks used to protect the source rack and 

mechanism that moves the rack from moving 

product carriers.

Access control Panoramic Test the completed access control system to ensure that 

it functions as designed and that all alarms, controls, and 

interlocks work properly.

Fire protection Panoramic Test the ability of the heat and smoke detectors to detect 

a fire, to activate alarms, and to cause the source rack to 

automatically become fully shielded. The licensee must 

test the operability of the fire extinguishing system. It is 

not necessary that licensees turn on extinguishers 

(i.e., water or chemicals) during tests of the operability of 

their fire protection systems.

Source return Panoramic Demonstrate that the source racks can be returned to 

their fully shielded positions without offsite power.

Computer 

systems

Panoramic that

use a computer 

system to control 

the access control 

system

Verify that the access control system will operate 

properly if offsite power is lost, and verify that the 

computer has security features that prevent an irradiator 

operator from commanding the computer to override the 

access control system when it is required to be operable.

Wiring Panoramic Verify that the electrical wiring and electrical equipment 

that were installed meet the design specifications 

(e.g., radiation-resistant wiring installed in appropriate 

locations and according to code).
APPENDIX I

SUGGESTED AUDIT CHECKLIST FOR 10 CFR PART 36 IRRADIATORS

I−1

Suggested Audit Checklist for 10 CFR Part 36 Irradiators

Note: Licensees may use the following audit form to self-assess the adequacy of the licensed 

program, identify program weaknesses, and allow licensees to take early corrective actions 

[before an inspection by the U.S. Nuclear Regulatory Commission (NRC)]. This form is not 

intended to be all inclusive. During an audit, the auditor needs to keep in mind not only the 

requirements of the NRC’s regulations, but also the licensee’s commitments in its applications 

and other correspondence with the NRC. Licensees are encouraged to modify the audit form as 

needed to include items specific to their licensed program (e.g., implementation of a security 

program). 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. This audit form includes references at the end.

Licensee’s name:_________________________ License No._________________________

Date of This Audit________________________

_______________________________________ Date_______________________________

(Auditor Signature)

_______________________________________ Date_______________________________

(Management Signature)

Audit History

A. Last audit of this location conducted on (date) _________________________________

B. Were previous audits conducted at intervals not to exceed 12 months? (Title 10 of the 

Code of Federal Regulations (10 CFR) 20.1101, “Radiation protection programs.”)

C. Were records of previous audits maintained? (10 CFR 20.2102, “Records of radiation 

protection programs.”)

D. Were any deficiencies identified during the last two audits or 2 years, whichever 

is longer?

E. Were deficiencies entered into the licensee’s corrective action program? 

F. Were corrective actions tracked and completed? 

Organization and Scope of Program

A. If the mailing address or places of use changed, was the license amended?

B. If ownership changed or bankruptcy was filed, was the U.S. Nuclear 

Regulatory Commission’s (NRC’s) prior consent obtained, or was the NRC notified?

C. Radiation Safety Officer (RSO)

1. If the RSO was changed, was the NRC notified and the license amended in a 

timely manner?
I−2

2. Does the new RSO meet the licensee’s training requirements?

3. Is the RSO fulfilling his or her duties?

4. To whom does the RSO report?

D. If the designated contact person for the NRC changed, was the NRC notified?

E. Sealed Sources and Devices (SSD)

1. Does the license authorize all of the regulated radionuclides contained 

in irradiators?

2. Have copies of (or access to) SSD certificates been provided?

3. Are the sealed sources and, if applicable, devices in accordance with the 

description in SSD registration certificates? (10 CFR 32.210, “Registration of 

product information.”)

4. Are there manufacturers’ manuals for operation and maintenance?

5. Are the actual uses of the irradiator consistent with the authorized uses listed on

the license?

6. Are the sealed sources used under conditions specified in the “Conditions of 

Normal Use” and “Limitations and/or Other Considerations of Use” on the SSD

registration certificates?

F. Is a commensurate security program implemented?

Training and Instructions to Workers

A. Were all workers who are likely to exceed 1 mSv (millisievert) [100 mrem] in a year

instructed per 10 CFR 19.12, “Instructions to workers”? 10 CFR 37.43 training 

conducted? Refresher training provided, as needed? Records maintained?

B. Did each individual permitted to operate the irradiator without a supervisor present, 

receive instructions according to the license commitments and 10 CFR 36.51, “Training” 

before operating the irradiator?

C. Are records of training, tests, safety reviews, and annual evaluations maintained for 

each authorized irradiator operator? [10 CFR 36.81(b), (c)]

D. Did individuals who perform nonroutine operations receive training before performing 

these operations?

E. Did interviews reveal that individuals know the emergency procedures?

F. Did this audit include observations of irradiator operations?

G. Do workers have familiarity with requirements for the following?
I−3

1. the radiation safety program

2. annual dose limits

3. Form NRC 4 and 5 (or equivalent)

4. 10 percent monitoring threshold

5. dose limits to embryo and fetus and declared pregnant worker

6. grave danger posting?

Radiation Survey Instruments and Radiation Monitors

A. Are all portable survey meters calibrated at least annually to an accuracy of ± 20 percent 

for the gamma energy of the sources in use? [10 CFR 36.57(c)]

B. Are portable survey meters of a type that does not saturate and read zero at high dose 

rates? [10 CFR 36.57(c)]

C. Are calibration records maintained?

D. Are all operable survey instruments able to detect 0.5 microsievert [0.05 mrem]

per hour?

E. Has the licensee evaluated the location and sensitivity of the radiation monitor to detect 

sources carried by the product conveyor system for automatic conveyor systems? 

[10 CFR 36.29(a)]

F. Has the licensee tested the operability and sensitivity of monitors used to detect the 

presence of high radiation levels in the radiation room before personnel entry at a 

frequency specified in the license application?

G. Has the licensee tested the operability and sensitivity of monitors used to detect 

contamination of pool water due to leaking sources? (Frequency of checks as specified 

in license application?)

H. For underwater irradiators not in a shielded radiation room, has the licensee tested the 

operability and sensitivity of monitors used to detect abnormal radiation levels? 

(Frequency of checks as specified in license application?)

Conductivity Meters

A. Are appropriate operable conductivity meters possessed and used?

B. Are conductivity meters calibrated at least annually? [10 CFR 36.63(b)]

Sealed Source Accountability Program

A. Are records maintained showing the receipt, location, transfer, and disposal of each 

sealed source? [10 CFR 30.51(a)(1)]
I−4

B. Is the material accountability program as described in the application being 

implemented? (License Condition)

C. Are transactions entered into the National Source Tracking System, including annual 

reconciliation? (10 CFR 20.2207)

Personnel Radiation Protection

A. Are as-low-as-is-reasonably-achievable (ALARA) considerations incorporated into the 

radiation protection program? [10 CFR 20.1101(b)]

B. Is documentation kept showing that unmonitored individuals receive ≤10 percent of the 

limit? [10 CFR 20.1502(a)]

C. Did unmonitored individuals’ activities change during the year that could put them over 

10 percent of the limit?

D. If yes to C above, was a new evaluation performed?

E. Is external dosimetry provided to individuals, as required by 10 CFR 36.55, “Personnel 

Monitoring,” and to individuals likely to receive >10 percent of the limit, including minors? 

Note that, in accordance with 10 CFR 20.1207, the annual occupational dose limit for 

minors is also 10 percent of the annual dose limits specified for adult workers.

1. Irradiator operators: Is the dosimetry supplier National Voluntary Laboratory 

Accreditation Program,” approved? [10 CFR 20.1501(c)]

2. Are the dosimeters exchanged monthly for film badges and quarterly for 

thermoluminescent dosimeters (TLDs) and optically stimulated luminescent 

dosimeters (OSLDs)? Note: Dosimeter change-out frequency should be 

specified by the RSO based on exposure history of the facility.

3. Are dosimetry reports reviewed by the RSO upon receipt?

4. Are dosimeters provided to persons who enter the radiation room of a panoramic 

irradiator? [10 CFR 36.55(b)]

5. Are annual checks of accuracy of pocket dosimeters performed? 

[10 CFR 36.55(b)]

6. Are the records NRC forms or the equivalent? [10 CFR 20.2104(d), 

10 CFR 20.2106(c)]

a. NRC Form 4 “Cumulative Occupational Exposure History” completed?

b. NRC Form 5 “Occupational Exposure Record for a Monitoring Period” 

completed?

7. Declared pregnant worker, embryo, or fetus

a. If a worker declared her pregnancy, did the licensee comply with 

10 CFR 20.1208, “Dose equivalent to an embryo/fetus”)?
I−5

b. Were records kept of embryo/fetus dose per [10 CFR 20.2106(e)]?

F. Are records of exposures, surveys, monitoring, and evaluations maintained 

[10 CFR 20.2102, “Records of radiation protection programs;” 10 CFR 20.2103,”Records 

of surveys;” 10 CFR 20.2106, “Records of individual monitoring results;” 

10 CFR 36.57(a)]?

Public Dose

A. Is public access controlled in a manner to keep doses below 1 mSv [100 mrem] in a 

year? [10 CFR 20.1301(a)(1)]

B. Has a survey or evaluation been performed according to 10 CFR 20.1501(a)? Have 

there been any additions or changes to the storage, security, or use of surrounding 

areas that would necessitate a new survey or evaluation?

C. Do unrestricted area radiation levels exceed 0.02 mSv [2 mrem] in any one hour? 

[10 CFR 20.1301(a)(2)]

D. Is access to sealed sources controlled in a manner that would prevent unauthorized use 

or removal? (10 CFR 20.1801)

E. Are records maintained? (10 CFR 20.2103; 10 CFR 20.2107)

Operating and Emergency Procedures

A. Have operating and emergency procedures been developed? (10 CFR 36.53, 

“Operating and emergency procedures”)

B. Do they address the required items in 10 CFR 36.53(b)?

C. Does each individual working with an irradiator have access to a current copy of the 

operating and emergency procedures (including emergency telephone numbers)?

D. Did any emergencies occur?

1. If so, how were they handled?

2. What corrective actions were taken?

3. Was NRC notification or reporting required? (10 CFR 20.2201, “Reports of theft 

or loss of licensed material;” 10 CFR 2202, “Notification of incidents,” 

10 CFR 2203, “Reports of exposures, radiation levels, and concentrations of

radioactive material exceeding the constraints or limits,” 10 CFR 30.50, 

“Reporting Requirements,” and 10 CFR 36.83, “Reports.”)

Leak Tests

A. Were sealed sources leak tested at prescribed intervals? (10 CFR 36.59, “Detection of 

leaking sources”

B. Were leak tests performed according to regulatory requirements? (10 CFR 36.59)
I−6

C. Are records of results retained with the appropriate information included?

D. Were any sealed sources found leaking and, if yes, what actions were taken, and was 

the NRC notified? (10 CFR 20.2201; 10 CFR 20.2203; 10 CFR 21.21, “Notification of 

failure to comply or existence of a defect or its evaluation;” 10 CFR 30.50, 

10 CFR 36.59, and 10 CFR 36.83)

Inspection and Maintenance Checks

A. Are all procedures for maintenance of the irradiator being followed?

B. Are all checks to determine proper functioning and wear of the source movement 

systems performed at frequencies as specified in the license application?

C. Are labels, signs, and postings clean and legible?

D. Are checks for operability as required by 10 CFR 36.61(a) (not included in item 4) 

performed at frequencies and according to procedures described in the license 

application, including for

1. each aspect of the access control system required by 36.23

2. the radiation monitor for radioactive contamination in pool water required by 

36.59(b) using a radiation check source, if applicable

3. the product exit monitor required by 36.29(a)

4. the emergency source return control required by 36.31(c)

5. heat and smoke detectors, extinguisher system required by 36.27 

(without turning extinguishers on)

6. the means of pool water replenishment required by 36.33(c)

7. the indicators of high and low pool water levels required by 36.33(d)

8. underwater irradiators, the over-pool radiation monitor required by 36.29(b)

9. underwater irradiators, the intrusion alarm required by 36.23(i)

E. Are checks for functioning and condition of equipment as required by 10 CFR 36.61(a) 

performed at required frequencies and according to procedures described in the license 

application, including

1. the source position indicator required by 36.31(b)

2. leak-tightness of systems through which pool water circulates (visual inspection)

3. system, mechanisms, and cables used to raise and lower sources

4. barrier to prevent products from hitting the sources or source mechanism as 

required by 36.35
I−7

5. amount of water added to the pool to determine if the pool is leaking 

6. electrical wiring on required safety systems for radiation damage

7. pool water conductivity measurements and analysis as required by 36.63(b)

Repair and Preventive Maintenance

A. Are repair and maintenance of components related to the radiological safety of the 

irradiator performed by the manufacturer or person specifically authorized by the NRC or 

an Agreement State and according to license requirements (e.g., extent of work;

procedures; dosimetry; survey instrument; compliance with 10 CFR 20.1301, “Radiation 

dose limits for individual members of the public,”)? (License Condition)

B. Are malfunctions and defects found during inspection and maintenance checks repaired 

without undue delay?

Transportation

Note: This section will not apply if the licensee has not transported sealed sources during the 

period covered by this audit.

A. Were sources shipped since the last audit?

B. If so, were 10 CFR Part 71, “Packaging and Transportation of Radioactive Material,” 

requirements followed?

C. Were U.S. Department of Transportation Type A or Type B packages used? 

(10 CFR Part 71, 49 CFR 173.415, 49 CFR 173.416) If Type B, was the NRC certificate 

of compliance granted before shipment or is shipper registered as a user of the Type B 

package? Does the shipper have an NRC-approved quality assurance program?

D. Are the package performance test records on file? [49 CFR 173.415(a)]

E. Is there special form sources documentation? [49 CFR 173.476(a)]

F. Did the package have two labels (e.g., Yellow II) with TI, Nuclide, Activity, and Hazard 

Class? (49 CFR 172.403, 49 CFR 173.441)

G. Was the package properly marked? (49 CFR 172.301, 49 CFR 172.304, 

49 CFR 172.310, 49 CFR 172.324)

H. Were packages closed and sealed during transport? [49 CFR 173.475(f)]

I. Were shipping papers prepared, used, and maintained? [49 CFR 172.200(a)]

J. Do shipping papers contain proper entries? [Shipping name, Hazard Class, Identification 

Number (UN Number), Total Quantity, Package Type, Nuclide, RQ, Radioactive 

Material, Physical and Chemical Form, Activity, category of label, TI, Shipper’s Name, 

Certification and Signature, Emergency Response Phone Number, Cargo Aircraft Only 

(if applicable)] (49 CFR 172.200, 49 CFR 172.201, 49 CFR 172.202, 49 CFR 172.203, 

49 CFR 172.204, 49 CFR 172.604)
I−8

K. Was the package secured against movement? (49 CFR 177.834)

L. If needed, was the vehicle placarded? (49 CFR 172.504)

M. Were overpacks used? Did overpack markings contain correct information?

(49 CFR 173.25)

N. If applicable, were safety and security plans developed in accordance with 49 CFR 172, 

Subpart I?

O. Were any incidents reported to the U.S. Department of Transportation? 

(49 CFR 171.15, 49 CFR 171.16)

P Was preplanning and coordination performed for shipments of category 1 or category 2 

quantities of radioactive material? (10 CFR 37.75)

Q. Was advance notification conducted for shipments of category 1 quantities of radioactive 

material? (10 CFR 37.77)

Auditor’s Independent Survey Measurements

A. Describe the type, location, and results of measurements. Does any radiation level 

exceed regulatory limits? [10 CFR 20.1501(a) and 10 CFR 1502(a)]

Notification and Reports

A. Was a telephone report made within 24 hours, as described in 10 CFR 36.83(b),

10 CFR 30.50(c)(1), and a written report within 30 days as described in 

10 CFR 30.50(c)(2) of any of the following:

1. source stuck in an unshielded position

2. any fire or explosion in a radiation room

3. damage to the source rack

4. failure of the cable or drive mechanism used to move the source racks

5. inoperability of the access control system

6. detection of radioactive contamination attributable to licensed 

radioactive material

7. structural damage to the pool liner or walls

8. abnormal water loss or leakage from the source storage pool

9. pool water conductivity exceeding 100 microsiemens per centimeter

B. Was any radioactive material lost or stolen? Were reports made? 

(10 CFR 20.2201)
I−9

C. Did any reportable incidents occur? Were reports made? 

(10 CFR 20.2202, 10 CFR 30.50)

D. Did any overexposures and high radiation levels occur? Were they reported? 

(10 CFR 20.2203, 10 CFR 30.50)

E. If any events (as described in items A through C above) did occur, what was the root 

cause? What were the corrective actions?

F. Is the management/RSO/shift foreman licensee aware of the telephone number for the 

NRC Emergency Operations Center? 301-816-5100

Posting and Labeling

A. Is NRC Form 3 “Notice to Workers” posted? 

(10 CFR 19.11, “Posting of notices to workers.”)

B. Are NRC regulations and license documents posted or a notice posted? 

(10 CFR 19.11, 10 CFR 21.6, “Posting requirements.”)

C. Is there other posting and labeling? (10 CFR 20.1902, “Posting requirements,” 

10 CFR 20.1904, “Labeling containers.”)

Radiation dose rates in the radiation room of a panoramic irradiator room will exceed 500 rad 

[5 Gray] per hour when the sources are exposed. Therefore, the radiation room should be 

posted as a very high radiation area, in accordance with 10 CFR 20.1902. Please note that 

the signs may be removed, covered, or otherwise made inoperative when the sources are fully 

shielded.

Recordkeeping for Decommissioning

A. Are records kept of information important to decommissioning? [10 CFR 30.35(g)]

B. Do records include all information outlined in 10 CFR 30.35(g)?

Bulletins and Information Notices

A. Have all NRC Correspondence (e.g., RISs, Bulletins, Information Notices, NMSS

newsletters) issued since last audit and applicable to 10 CFR Part 36 Irradiators 

been reviewed?

B. For correspondence that is applicable, has appropriate action been taken (e.g., training, 

updating procedures, etc.), as necessary?

Special License Conditions or Issues

A. Did an auditor review special license conditions or other issues 

(e.g., nonroutine operations)?

Deficiencies Identified in Audit; Corrective Actions

A. Summarize problems or deficiencies identified during audit.
I−10

B. If problems or deficiencies are identified in this audit, describe corrective actions planned 

or taken. Are corrective actions planned or taken at ALL licensed locations (not just the 

location audited)? Include the date(s) when corrective actions are implemented.

C. Provide any other recommendations for improvement.

Evaluation of Other Factors

A. Is senior licensee management appropriately involved with the radiation protection 

program and radiation safety officer (RSO) oversight?

B. Does the RSO have sufficient time to perform his or her radiation safety duties?

C. Does the licensee have sufficient staff to support the radiation protection program?

D. Does the facility have a sufficient number and variety of radiation protection instruments 

and systems to enable the safe conduct of irradiator operations?

E. Does security of radioactive materials (10 CFR 37) address the following?

1. Background Investigations and Access Control Program (10 CFR 37, Subpart B)

2. Physical Protection Requirements During Use (10 CFR 37, Subpart C)

3. Physical Protection in Transit (10 CFR 37, Subpart D)

4. Records (10 CFR 37, Subpart F)
APPENDIX J

MODEL RADIATION SURVEY INSTRUMENT CALIBRATION PROGRAM

J−1

Model Radiation Survey Instrument Calibration Program

Training

Before independently calibrating radiation survey instruments, the individual should complete 

both classroom and on-the-job training, as follows:

• Classroom training may be in the form of lecture, video, computer-based, or self-study 

and will cover the following subject areas:

— principles and practices of radiation protection

— radioactivity measurements, monitoring techniques, and the use of radiation 

detection instruments

— mathematics related to the use and measurement of radioactivity

— biological effects of radiation

• On-the-job-training will be consist of the following:

— observed authorized personnel performing radiation survey instrument calibration

— conducted radiation survey meter calibrations under the supervision, and in the 

physical presence of, an individual already authorized to perform calibrations

Facilities and Equipment

To reduce doses received by individuals not calibrating radiation survey instruments, 

calibrations will be conducted in an isolated area of the facility or at times when no one else 

is present.

The calibration source should be well-collimated, and the calibration area should be designed to 

minimize scatter of radiation, which could affect the calibration process.

The calibration area should be appropriately controlled so that persons entering the area will be 

aware if a radiation source is in use. 

Evaluate posting of the calibration area with appropriate radiation warning signs, as required by 

10 CFR Part 20, Subpart J.

Individuals conducting calibration of radiation survey instruments 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.

Frequency of Calibration of Radiation Measurement Instruments

A licensee committed to a routine or emergency radiation survey program should perform an 

acceptable calibration of all radiation measurement instruments annually as specified in 

10 CFR 36.57(c).
J−2

Special calibrations should be performed at any time there is reason to believe that the 

operating characteristics of a radiation measurement instrument have changed, by repair or 

alteration, or whenever system performance is observed to change significantly.

Routine maintenance of radiation measurement instruments should be performed as 

recommended by the manufacturer.

Primary or secondary standard instruments used to calibrate radiation measurement

instruments should be inspected frequently for consistency of performance.

Calibration Sources for Dose and Dose Rate Measuring Instruments

Radioactive sealed sources will be used for calibrating dose and dose rate measuring radiation 

survey instruments; these sources will have the following characteristics:

• The sources should approximate a point source.

• Calibration fields from gamma sources should be known with an accuracy when 

compared to secondary or primary national standards of 5 percent for dose rates 

greater than or equal to 1.0 μGy/hr [0.1 mrad/h] and 10 percent for dose rates less than 

1.0 μGy/hr [0.1 mrad/hr].

• The sources should contain a radionuclide that emits radiation of identical or similar type 

and energy as the environment in which the calibrated device will be used.

• The sources should be strong enough to give an exposure rate of at least 

7.7 microcoulomb per kilogram per hour [30 milliroentgen per hour] at 100 centimeters 

{e.g., 3.1 gigabecquerels [85 millicuries] of cesium-137 or 780 megabecquerels 

[21 millicuries] of cobalt-60}.

Note: Inverse square and radioactive decay laws should be used to correct changes in 

exposure rate due to changes in distance or source decay.

Calibration of Dose or Dose Rate Measuring Instruments

There are three kinds of scales frequently used on dose or dose-rate survey meters. These are 

calibrated as follows:

• Linear readout instruments with a single calibration control for all scales should be 

adjusted at the point recommended by the manufacturer or at a point within the normal 

range of use. Instruments with calibration controls for each scale should be adjusted on 

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/hr [1.0 mrad/hr]; ±× = ±30%

— 10 μGy/hr [1.0 mrad/hr) to 1.0 mGy/hr [100 mrad/hr]; ±× = ±20%

— 1.0 mGy/hr [100 mrad/hr) to 10 Gy/hr [1000 Rad/hr]; ±× = ±10%

• Logarithmic readout instruments, which commonly have a single readout scale 

spanning several decades, normally have two or more adjustments. Adjust the 
J−3

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 50 microcoulomb per kilogram per hour [200 milliroentgen per hour]

need not be calibrated, unless the licensee expects to make measurements at higher dose 

rates; regardless, such scales should be checked for operation and response to radiation.

Note: Instruments used to monitor higher energies are most easily calibrated in known 

radiation fields produced by sources of gamma rays of approximately the same energies as 

those to be measured.

Calibration Records

Calibration records for all radiation survey instruments should indicate the procedure used and 

the results of the calibration. The records should include the following:

• the owner or user of the radiation survey instrument

• a description of the radiation survey instrument that includes the manufacturer’s name, 

model number, serial number, and type of detector

• a description of the calibration source, including the exposure rate at a specified 

distance or activity on a specified date

• for each calibration point, the calculated exposure rate, the indicated exposure rate or

count rate, the deduced correction factor (the calculated exposure rate or count rate

divided by the indicated exposure rate or count rate), and the scale selected on the 

radiation survey instrument

• the exposure reading indicated with the radiation survey instrument in the “battery 

check” mode (if available on the instrument)

• for radiation survey instruments with external detectors, the angle between the radiation 

flux field and the detector (i.e., parallel or perpendicular)

• for radiation survey instruments with internal detectors, the angle between the radiation

flux field and a specified surface of the instrument

• for radiation survey detectors with removable shielding, an indication whether the 

shielding was in place or removed during the calibration procedure

• the exposure 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
J−4

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 radionuclide used to calibrate the 

radiation survey instrument (with correction factors) for each scale

• for surface contamination measurement instruments, the efficiency of the radiation 

survey instrument, for each radionuclide the instrument will be used to measure 

(if efficiency is not calculated before each use)

• for each scale or decade not calibrated, an indication that the scale or decade was 

checked only for function but not calibrated

• the date of calibration and the next calibration due date

• the apparent exposure rate or count rate from the check source, if used

References: Detailed information about portable radiation survey instrument calibration may be 

obtained by referring to American National Standards Institute (ANSI)-N323AB-2013, “American 

National Standard for Radiation Protection Instrumentation Test and Calibration, Portable 

Survey Instruments.”
APPENDIX K

GUIDANCE FOR DEMONSTRATING THAT UNMONITORED INDIVIDUALS 

ARE NOT LIKELY TO EXCEED 10 PERCENT OF THE ALLOWABLE 

OCCUPATIONAL DOSE LIMITS

K–1

Guidance for Demonstrating that Unmonitored Individuals Are Not Likely to 

Exceed 10 Percent of the Allowable Occupational Dose Limits

Dosimetry is required for individuals likely to receive in a year, from sources external to the 

body, a 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.” However, 

irradiator operators are required by 10 CFR 36.55(a) to wear a personnel dosimeter that is 

processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program 

processor while operating a panoramic irradiator or while in the area around the pool of an 

underwater irradiator. As discussed in Item 8.10.4, these personnel dosimeters may be film 

badges, thermoluminescent dosimeters (TLDs) or optically stimulated luminescence dosimeters. 

Also, other individuals who enter the radiation room of a panoramic irradiator must wear a 

dosimeter, which may be a pocket dosimeter. When groups of visitors enter the radiation room,

at least two people must wear dosimeters. In those instances where pocket chambers are used 

instead of film badges or TLDs, a check of the response of the dosimeters to radiation must be 

made at least annually. Acceptable dosimeters must read within plus or minus 30 percent of the 

true radiation dose. To demonstrate that dosimetry is not required for other workers, a licensee 

needs to have available, for inspection, an evaluation to demonstrate that its workers are not 

likely to exceed 10 percent of the applicable annual limits.

The most common way that individuals might exceed 10 percent of the applicable limits is by 

performing work near the irradiator shield or areas of cable or equipment penetration of the 

shield of the irradiator. However, for most irradiators, even these activities result in the 

individual receiving minimal doses. A licensee will need to evaluate the doses that its workers 

might receive in performing these tasks to assess whether dosimetry is required. The 

evaluation may be completed by carefully measuring the dose rates when the source is in the 

irradiate position, using techniques similar to those described in Appendix L of this NUREG. An 

evaluation of the actual time workers spend in the area can provide the information needed to 

estimate the annual dose of the workers.

The applicable total effective dose equivalent (whole body) limit is 50 millisievert (mSv) [5 rems]

per year, and 10 percent of that value is 5 mSv [500 millirems] per year.

Example: A careful measurement of the highest dose rate at the face of the shield of a 

panoramic irradiator is found to be 0.015 mSv/hr (millisievert per hour) [1.5 mrem/hr]. An 

individual is expected to spend no more than 3 hours per week in the area near the shield. 

Based on the dose rate, assuming the source is continuously in the irradiate position while the 

work is being performed, the annual dose is expected to be less than 2.34 mSv [234 mrem]

(i.e., 3 hr/wk × 1.5 mrem/hr × 52 wk/yr). Based on the above specific information, no dosimetry 

is required if the individual performs work in the area less than 6.4 hours per week.

APPENDIX L

GUIDANCE FOR DEMONSTRATING THAT INDIVIDUAL MEMBERS OF THE 

PUBLIC WILL NOT RECEIVE DOSES EXCEEDING THE ALLOWABLE LIMITS

L–1

Guidance for Demonstrating that Individual Members of the Public Will Not 

Receive Doses Exceeding the Allowable Limits

This appendix describes methods for determining radiation doses to members of the public. 

Licensees must ensure that:

• the radiation dose received by individual members of the public does not exceed 

1 millisievert (mSv) [100 millirem (mrem)] in one calendar year resulting from the 

licensee’s possession or use of licensed materials [10 CFR 20.1301(a)(1)]

Members of the public include persons who live, work, or may be near locations where an 

irradiator is used or where the sealed sources for the irradiator are stored and employees 

whose assigned duties do not include the use of licensed materials and who work in the 

vicinity where irradiators are used or sources stored.

• the radiation dose in unrestricted areas does not exceed 0.02 mSv [2 mrem] in any 

one hour (10 CFR 1301(a)(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.

Licensees must show compliance with both portions of the regulation. For areas around 

irradiator facilities, a combination of calculations and measurements [e.g., using an

environmental thermoluminescent dosimeter (TLD) or optically stimulated luminescence 

dosimeter (OSLD)] is often used to prove compliance.

Combined Measurement–Calculational Method1

These measurements must be made with calibrated 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 

2,080 hours (i.e., a “work year” of 40 hr/wk for 52 wk/yr) is equal to less than 0.5 microsievert 

[0.05 mrem] per hour.

 

1For ease of use, the examples in this appendix use conventional units. The conversions to SI units are as follows: 

1 ft = 0.305 m; 1 mrem = 0.01 mSv.
L–2

Instruments used to make low radiation dose measurements for calculations must be sufficiently 

sensitive. An instrument equipped with a scintillation-type detector [e.g., NaI(Tl)] or a micro-R 

meter used in making very low gamma radiation measurements should be adequate.

Licensees may also choose to use environmental TLDs2 in unrestricted areas next to the 

irradiator 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.

The combined measurement-calculational method may be used to estimate the maximum dose 

to a member of the public. Because Title 10 of the Code of Federal Regulations (10 CFR)

Part 36, “Licenses and Radiation Safety Requirements for Irradiators,” irradiators are designed 

so that the maximum dose rate in any public area is less than 0.02 mSv [2 mrem] in any one 

hour, the licensee will generally be able to show by calculation that the maximum dose to an 

individual will be less than the 1 mSv/yr [100 mrem/yr] limit. The combined measurementcalculational 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 

assumptions: (i) dose rates near the outside of a shield wall will decrease linearly with distance 

(d) in feet (i.e., 1/d), (ii) typical radiation levels encountered when the source is in the unshielded 

position, and (iii) no credit is taken for any shielding found between the irradiator shield 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.

Assuming dose rates near the outside of a shield wall decrease linearly with distance provides 

a reasonable approximation for a planar source.

NOTE: This calculational method only provides an estimate of maximum public dose. A 

licensee should make actual measurements at various distances in order to demonstrate 

compliance with the public dose limit.

Part 1 of the combined measurement-calculational 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 distance law to determine if the distance between the irradiator 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 provide a method for estimating 

conservative doses that could be received.

Example

 

2TLDs and OSLDs used for personnel monitoring (e.g., lithium fluoride) may not have sufficient sensitivity for this

purpose. For example, there may be a TLD with a minimum reportable level of 10 mrem that is used to monitor

doses received, and is changed once a month. If the measurements are at the minimum reportable level, the annual 

dose received could reach 1.2 mSv [120 mrem], a value in excess of the 1 mSv/yr [100 mrem/yr] limit. If licensees 

use TLDs/OSLDs to evaluate compliance with the public dose limits, they should consult with their TLD/OSLD 

supplier and choose TLDs/OSLDs with a sufficient sensitivity, such as those that are used for

environmental monitoring.
L–3

To better understand the combined measurement-calculational method, we will examine 

Food-Safe, Inc., an irradiator licensee. Yesterday, the company’s president noted that the 

shield of the new irradiator area is close to an area used by workers whose assigned duties do 

not include the use of licensed materials, and he asked the radiation safety officer (RSO) to 

determine if the company is complying with the U.S. Nuclear Regulatory Commission’s (NRC’s)

regulations.

The area in question is near the wall, which constitutes the primary shield of the irradiator. The 

RSO measures the distance from the shield to the 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 

0.5 mrem per hour.

Table L–1 summarizes the information the RSO has on the irradiator.

Table L–1. Information Known About Dose at the Shield of the Irradiator

Description of Known Information Co-60 Panoramic Irradiator

Dose rate encountered at 1 foot from the face of the shield, in 

mrem/hr.

0.5 mrem/hr.

Distance from the face of the shield to the nearest occupied 

work area, in ft.

4 ft

Example: Part 1

The RSO’s first thought is that the distance between the irradiator 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, he assumes: 

(i) the irradiator is constantly in use (i.e., 24 hr/day), and (ii) the workers are constantly in the 

unrestricted work area (i.e., 24 hr/day). The RSO proceeds to calculate the dose the workers 

might receive hourly and yearly from the irradiator as shown in Table L–2 below.

Table L–2. Calculational Method, Part 1: Hourly and Annual Dose Received 

From Irradiator

Step No. Description Input Data Results

1 Multiply the measured dose rate measured at 

1.0 ft from the face of the shield wall in mrem/hr 

by the distance (ft) at which the measurement 

was made (e.g., 1 foot from the face of 

the shield)

0.5 × (1) 0.5

2 Record the distance (ft) from the face of the 

shield to the nearest unrestricted area

4

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 IRRADIATOR, in 

mrem in an hour

0.5/4 0.125

4 Multiply the result of Step 3 by 40 hr/work week 

× 52 weeks/year = MAXIMUM ANNUAL DOSE 

RECEIVED FROM IRRADIATOR, in mrem in 

a year

0.125 × 40 × 52 260

Note: The result in Step 3 demonstrates compliance with the 2 mrem in any one hour limit. Reevaluate if 

assumptions change. If the result in Step 4 exceeds 100 mrem/yr, proceed to Part 2 of the calculational method.
L–4

At this point, the RSO is pleased to see that the total dose that an individual could receive in any 

one hour is only 0.125 mrem in an hour, less than the 2 mrem in any one-hour limit but notes 

that an individual could receive a dose of 260 mrem in a year, higher than the 100 mrem limit.

Example: Part 2

The RSO reviews the assumptions and recognizes that the workers are not in the area near the 

shield 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 irradiator is in constant use 

(24 hours per day (hr/day)]. The annual dose received is then recalculated.

Table L–3. Calculational Method, Part 2: Annual Dose Received From a 

10 CFR Part 36 Irradiator

Step No. Description Results

5 A. Average number of hours per day an individual spends in 

area of concern (e.g., a nonradiation worker spends 

1.5 hr/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, 

groundskeeping, 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

6 Multiply the results of Step 5.A. by the results of Step 5.B. by 

the results of Step 5.C. = AVERAGE NUMBER OF HOURS 

IN AREA OF CONCERN PER YEAR

1.5 × 5 × 52 = 390

7 Multiply the results in Step 3 by the results of Step 6 = 

ANNUAL DOSE RECEIVED FROM IRRADIATOR 

CONSIDERING REALISTIC ESTIMATE OF TIME SPENT IN 

AREA OF CONCERN, in mrem in a year

0.125 × 390 = 49

The RSO is pleased to note that the calculated annual dose received is significantly lower and 

does not exceed the 100 mrem in a year limit.

Because most irradiators are in use a majority of the time, and down time is usually 

unpredictable, generally no additional allowance for irradiator duty cycle is made.

The RSO is glad to see that the results in Step 7 show compliance with the 100 mrem in a year 

limit. Had the result in Step 7 been higher than 100 mrem in a year, then the RSO could have 

done one or more of the following:

• considered whether the assumptions used to determine occupancy are accurate, revise 

the assumptions as needed, and recalculate using the new assumptions
L–5

• calculated the effect of any shielding3 located between the irradiator shield and the 

public area—such calculation is beyond the scope of this appendix

• taken corrective actions (e.g., change work patterns to reduce the time spent in the area 

near the shield) and performed new calculations to demonstrate compliance

• designated 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, 

“Instructions to workers”

Note that in the example, the RSO evaluated the unrestricted area outside only one wall of the 

irradiator area. Licensees also need to make similar evaluations for other unrestricted areas 

and to keep in mind the as low as reasonably achievable principle, taking reasonable steps to 

keep radiation dose received below regulatory requirements. In addition, licensees need to be 

alert to changes in situations (e.g., adding sources to the irradiator, changing the work habits of 

the workers, or otherwise changing the estimate of the portion of time spent in the area in 

question) and to perform additional evaluations, as needed.

RECORDKEEPING: 10 CFR 20.2107, “Records of dose to individual members of the public,” 

requires licensees to maintain records demonstrating compliance with the dose limits for 

individual members of the public.

 

3National Council on Radiation Protection and Measurements Report No. 49, “Structural Shielding Design and

Evaluation for Medical Use of X-Rays and Gamma Rays of Energies Up to 10 MeV,” contains helpful information. It 

is available from NCRP, 7910 Woodmont Avenue, Suite 400, Bethesda, Maryland 20814. NCRP’s telephone number 

is 301-657-2652.

APPENDIX M

MODEL LEAK TEST PROGRAM FOR DRY-SOURCE-STORAGE 

IRRADIATOR SEALED SOURCES

M–1

Model Leak Test Program for Dry-Source-Storage Irradiator Sealed Sources

Training

Before allowing an individual to perform leak testing and sample analysis, the radiation safety 

officer (RSO) will ensure that he or she has sufficient classroom and on-the-job training to be

competent to perform leak tests independently.

Classroom training may be in the form of lecture, online, video, or self-study and will cover the 

following subject areas:

• principles and practices of radiation protection

• radioactivity measurements, monitoring techniques, and the use of instruments

• mathematics and calculations used for measuring radioactivity

• biological effects of radiation

Appropriate on-the-job-training consists of

• 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, leak tests will be 

analyzed 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 with a single or multichannel 

analyzer to count samples from sealed sources containing gamma-emitters such as

cobalt-60).

If the sensitivity of the counting system is unknown, determine the minimum detectable activity 

(MDA). The MDA may be determined using the following formula:

MDA =

2.71 + 4.65 �bkg ×t

t ×E

where: MDA=minimum detectable activity in disintegrations per minute (dpm)

bkg=background count rate in counts per minute (cpm)

t=background counting time in minutes

E=detector efficiency in counts per disintegration
M–2

For example:

where: bkg=200 cpm

E=0.1 counts per disintegration (10 percent efficient)

t=2 minutes

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 above assumes that counting times for the background 

measurement and for the sample will be equal. MDA equations for nonequal counting times, as 

well as derivations of equations and discussions of limitations, can be found in 

“Decommissioning Health Physics—A Handbook for MARSSIM Users,” Eric W. Abelquist, 

published by Taylor & Francis Group, 2001. The MDA for the instrument should be a fraction 

(10 to 50 percent) of the criteria that must be met.

Frequency for Conducting Leak Tests of Sealed Sources

• Leak tests will be conducted at least every 6 months.

Model Procedure for Performing Leak Testing and Analysis

• For each sealed source to be tested, list identifying information such as serial number, 

manufacturer, model number, radionuclide, and activity.

• Use an appropriately sensitive radiation survey meter to monitor exposure.

• Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source.1

• 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 (see manufacturer’s instructions, if available).

 

1Prepare one swipe per irradiator, even if more than one source is contained in the same enclosure.
M–3

• Select an instrument that is sensitive enough to detect 200 becquerels 

[0.005 microcurie] of the radionuclide.

• 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 ±5 percent of the stated value and traceable to primary 

radiation standards such as those maintained by the National Institutes of Standards 

and Technology 

• Calculate the counting efficiency of the detector.

Efficiency in cpm/Bq = [(cpm from std) – (cpm from bkg)]

activity of std in Bq

where cpm=counts per minute

std=standard 

bkg=background

Bq=becquerel

• Count each wipe sample; determine net count rate.

• For each sample, calculate and record estimated activity in becquerels (or microcuries). 

The activity of the sample in becquerels may be calculated using the following formula:

Activity of sample [Bq] = [(cpm from wipe sample) - (cpm from bkg)]

efficiency in cpm/Bq

• Sign and date the list of sources, data, and calculations. Retain records for 3 years 

[under Title 10 of the Code of Federal Regulations (10 CFR) 20.2103(a)].

• If the wipe test activity is 200 becquerels [0.005 microcurie] or greater, notify the 

radiation safety officer, so that the source can be withdrawn from use and disposed of 

properly. Also notify NRC in accordance with the reporting requirements outlined in 

10 CFR 30.50.

APPENDIX N

U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS

N–1

U.S. Department of Transportation Regulations

Note: The following list of U.S. Department of Transportation (DOT) regulations is provided to 

inform licensees about typical requirements that apply to the transportation of licensed material 

including the preparation of shipments of licensed material. Licensees should note that the list 

is incomplete in that not all potentially applicable requirements have been included. Also, 

transportation requirements change; therefore, licensees should consult the regulations for 

definitive information about current requirements. Additional information on transportation 

requirements may be found at the DOT Web site: https://www.dot.gov/.

The following are the major areas in DOT regulations most relevant for shipping and 

transporting Type B quantities of radioactive material:

A. Table of Hazardous Materials and Special Provisions—49 CFR 172, Subpart B

1. 49 CFR 172.101—Purpose and use of hazardous materials table

[proper shipping name, hazard class, identification number]

2. Table 2, Appendix A to 49 CFR 172.101—List of Hazardous Substances and 

Reportable Quantities [for radionuclides]

B. Shipping Papers—49 CFR 172, Subpart C

1. 49 CFR 172.201—Preparation and retention of shipping papers

2. 49 CFR 172.202—Description of hazardous material on shipping papers

3. 49 CFR 172.203—Additional description requirements

4. 49 CFR 172.204—Shipper’s certification 

C. Package Markings—49 CFR 172, Subpart D

1. 49 CFR 172.301—General marking requirements for non-bulk packaging

2. 49 CFR 172.304—Marking requirements

3. 49 CFR 172.310—Class 7 (radioactive) material [Type B]

4. 49 CFR 172.324—Hazardous substances in non-bulk packaging [designation of 

“reportable quantities” with the letters “RQ”]

D. Package Labeling—49 CFR 172, Subpart E

1. 49 CFR 172.400—General labeling requirements

2. 49 CFR 172.403—Class 7 (radioactive) materials [types and contents of labels]

3. 49 CFR 172.406—Placement of labels

E. Placarding of Vehicles—49 CFR 172, Subpart F

1. 49 CFR 172.504—General placarding requirements

2. 49 CFR 172.516—Visibility and display of placards

3. 49 CFR 172.556—RADIOACTIVE placard
N–2

F. Emergency Response Information—49 CFR 172, Subpart G

1. 49 CFR 172.600—Applicability and general requirements

2. 49 CFR 172.602—Emergency response information

3. 49 CFR 172.604—Emergency response telephone number

G. Training—49 CFR 172, Subpart H

1. 49 CFR 172.702—Applicability and responsibility for training and testing 

[for HAZMAT employees]

2. 49 CFR 172.704—Training requirements [includes types of training, when it must 

be conducted, need for refresher training every three years, recordkeeping]

H. Safety and Security Plans—49 CFR 172, Subpart I

1. 49 CFR 172.800—Purpose and applicability

2. 49 CFR 172.802—Components of a security plan

I. Shippers—General Requirements for Shipments and Packaging—49 CFR Part 173

1. 49 CFR 173.25—Authorized packaging and overpacks

2. 49 CFR 173.403—Definitions

3. 49 CFR 173.413—Requirements for Type B packages

4. 49 CFR 173.416—Authorized Type B packages [includes packaging 

certification requirements]

5. 49 CFR 173.433—Requirement for determining basic radionuclide values and for 

listing of radionuclides on shipping papers and labels

6. 49 CFR 173.435—Table of A1 and A2 values for radionuclides

7. 49 CFR 173.441—Radiation level limitations and exclusive use provisions

8. 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory Commission 

approved packages

9. 49 CFR 173.475—Quality control requirements for shipments of class 7 

radioactive material

10. 49 CFR 173.476—Approval of special form Class 7 (radioactive) materials 

[includes requirement for documentation of special form status]

J. Carriage by Public Highway—49 CFR Part 177

1. 49 CFR 177.817—Shipping papers [location of shipping papers during transport]

2. 49 CFR 177.842—Class 7 (radioactive) material [includes requirement for 

blocking and bracing during transport]
N–3

Applicants should visit the U.S. Department of Transportation Web site for additional information 

on transportation requirements: https://www.dot.gov/. 

Current references can be confirmed at this link:

https://www.ecfr.gov/cgi-bin/textidx?SID=ae47aa49a6dcae060b3484c34f467f45&c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2_02.tpl

Note: The reference charts included at the end of this appendix are for reference only and are 

not a substitute for U.S. Department of Transportation (DOT) and U.S. Nuclear Regulatory 

Commission (NRC) transportation regulations.
N–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/non-exclusive 

use[9]

IP-3: non-exclusive 

use - -

Alternative 

Provisions for 

Domestic only 

Transport[8]

Packaging shall meet the requirements of §§ 173.24, 24a, and 173.410.

Transportation shall be an exclusive use shipment.

Activity per shipment must be less than an A2 quantity (see § 173.427(b)(4)).

[1] Additional provisions may apply for radioactive materials that are pyrophoric, oxidizing, fissile excepted, or uranium hexafluoride. 

[2] Each NRC licensee shall comply with the applicable requirements of the DOT regulations in 49 CFR parts 107, 171 through 180, 

and 390 through 397 (see § 71.5).

[3] Materials that contain radionuclides, where both the activity concentration and the total activity in the consignment exceed either the 

values specified in the table in § 173.436 or the values derived according to the instructions in § 173.433, must be regulated in 

transport as Class 7 (radioactive) material. 

[4] Except for LSA material and SCO, a Type A package may not contain a quantity of Class 7 (radioactive) material greater than A1 or 

A2 (see § 173.431(a)). See A1 and A2 definitions in § 173.403.

[5] The external dose rate from LSA material or SCO in a single package may not exceed 10 mSv/h (1 rem/h) at 3 meters from the 

unshielded material or objects (see §§ 173.427(a)(1) and (d)). 

[6] LSA material and SCOs that are or contain fissile material in quantities that are not fissile excepted must be packaged in appropriate 

Type AF or Type BF packages, and not classified as LSA material or SCO. For alternate domestic transport provisions, see 

§ 173.427(b)(4). For comprehensive guidance on packaging and transportation of LSA material and SCO, see NUREG-1608.

[7] For the quantity of LSA material and SCO transported in a single conveyance, see the limits specified in § 173.427(a)(2).

[8] LSA material or SCO shall be appropriately packaged in accordance with § 173.427(b) or (d). Certain LSA-I material and SCO-I may 

be transported unpackaged under the conditions in § 173.427(c).

[9] See §§ 173.411(c) and 173.415(a) for requirements related to package record retention (2 years) and associated documentation of 

physical tests. 

[10] See §§ 71.22(a), 71.23(a) and 173.417(a) for regulations regarding the use of non-AF packages for fissile materials. 
N–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.
N–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.
N–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.
N–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., 

RADIOACTIVE-LSA, 

RADIOACTIVE-SCO, or 

RQ, as appropriate).

For an overpack, the 

marking “OVERPACK” in 

lettering 12 mm 

(0.5 inches) high. This 

marking is not required if 

the package type 

contained in the overpack 

is visible from the outside

[see § 173.25].

• Radiation (trefoil) symbol[3] on outside of outermost 

receptacle of each Type B(U) or Type B(M) 

packaging design

• Each NRC-approved package (e.g., Type AF, Type B(U), Type B(M), 

Type B(U)F, and Type B(M)F) must be marked with the identification 

marking indicated in the package approval

• For Specification 7A packaging, mark on the outside with “USA DOT 7A 

Type A”, and the name and address or symbol of the manufacturer 

satisfying §§ 178.3 and 178.350

Materials-based requirements:

• For a non-bulk IP–1 package containing a liquid, use 

underlined double arrow symbol indicating upright 

orientation[4], where the symbol is placed on two 

opposite sides of the packaging [see § 172.312]

• For a non-bulk package containing a hazardous substance, mark the 

outside of each package with the letters “RQ” in association with the 

proper shipping name

Administrative-based requirements:

• For each Type B(U), Type B(M) or fissile material package destined for 

export shipment, mark “USA” in conjunction with specification marking, 

or certificate identification; and package identification indicated in the 

U.S. Competent Authority Certificate

• Mark “DOT–SP” followed by the special permit number assigned for 

each package authorized by special permit

• Competent authority identification marking and revalidation for foreign 

made Type B(U), Type B(M), Type H(U), Type H(M), or fissile material 

package for which a Competent Authority Certificate is required

Special Considerations for Marking Requirements

• All markings are to be (a) on the outside of each package, (b) durable and legible, (c) in English, (d) printed on or affixed to the surface of a 

package or on a label, tag, or sign, (e) displayed on a background of sharply contrasting color, and (f) unobscured by labels or 

attachments.

• When an overpack is used, see §§ 173.25 and 173.448(g) for marking requirements.

[1] Some marking exceptions exist for excepted packages, as specified in §§ 173.421, 173.422, 173.424, 173.426 and 173.428. 

[2] If the identification number marking on a bulk package is not visible, the transport vehicle or freight container must be marked on each 

side and each end [see § 172.331].

[3] The radiation symbol shall be resistant to the effects of fire and water, plainly marked by embossing, stamping or other means resistant 

to the effects of fire and water and conform to the size requirements of Appendix B to Part 172.

[4] The arrows must be either black or red on white or other suitable contrasting background and commensurate with the size of the 

package; depicting a rectangular border around the arrows is optional.
N–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.
N–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 nonfissile, fissile-excepted, or fissile uranium hexafluoride [see § 172.505(b)].

• Placards are also required for subsidiary hazards of POISON INHALATION HAZARD, POISON GAS, or DANGEROUS WHEN WET 

[see § 172.505].

[1] See § 172.512 for exceptions and variations to the placarding requirements for freight containers and aircraft unit load devices. 

[2] See § 173.403 for the definition of Highway Route Controlled Quantity (HRCQ). A package containing an HRCQ must be labeled 

with RADIOACTIVE Yellow-III labels [see §§ 172.403(c) and 172.507(a)].

[3] Required placarding of the front of a motor vehicle may be on the front of a truck-tractor instead of or in addition to the placarding 

on the front of the cargo body to which a truck-tractor is attached § 172.516(b).
N–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/outreach-training/erg.
N–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 O

EXEMPTIONS FOR TELETHERAPY UNITS CONVERTED TO 

NONHUMAN USE

O–1

Exemptions for Teletherapy Units Converted to Nonhuman Use

The following are technical justifications and commitments, which are acceptable to exempt 

licensees from specific sections of Title 10 of the Code of Federal Regulations (10 CFR)

Part 36, “Licenses and Radiation Safety Requirements for Irradiators.” The NRC Regional 

Offices may grant the exemptions shown below without prior coordination with the Office of 

Nuclear Material Safety and Safeguards (NMSS). Acceptable license conditions are also 

shown below.

1. 10 CFR 36.23(a) - “The personnel entrance door or barrier must have a lock that is 

operated by the same key used to move the sources.”

For converted teletherapy units, the use of a single key or even several keys on a keyring may be impractical. The key switch on many control panels is a three-position 

switch, which controls electrical power to the teletherapy unit. The key can only be 

inserted and removed in the “off” position, and in this position the main power and 

control circuits are without electrical power. Power is required to conduct such activities 

as move collimators, activate field lights, and align systems. Requiring a single key 

would not allow the licensee to operate these powered systems.

Therefore, a licensee may be exempted from this requirement, provided that the 

licensee commits to have the operator present for the entire period of time that the key is 

in the control panel.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.23(a), the licensee may use 

separate keys to operate the lock on the personnel entrance door or barrier and 

to move the sources in accordance with procedures described in the 

letter/application dated ________.”

2. 10 CFR 36.23(b) - “Each entrance to a radiation room at a panoramic irradiator must 

have an independent backup access control to detect personnel entry while sources are 

exposed.”

The licensee may be granted an exemption from this requirement provided that the 

licensee has an electrical interlock system meeting all of the conditions specified in 

10 CFR 35.615(b) on each entrance to the radiation room. Alterations of the electrical 

interlocks of the teletherapy unit to meet the requirements of 10 CFR 36.23(b) may 

cause the interlock system to function incorrectly. A working electrical interlock system 

on each entrance suffices to prevent personnel entry while the source is exposed. The 

licensee should commit in its application to each of the conditions of 10 CFR 35.615(b). 

In addition, the licensee should commit to having an operator present during the entire 

irradiation who can visually observe the entrance, and to having a radiation monitor that 

can be read before entering the radiation area.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.23(b), the licensee is exempt 

from having an independent backup access control to detect personnel entry 
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while sources are exposed based on the commitments described in the 

letter/application dated ________.”

3. 10 CFR 36.23(c) - “The monitor must be integrated with personnel access door locks to 

prevent room access when radiation levels are high.”

Alteration of the interlock system to meet this requirement would prevent entry to the 

treatment room to remove a patient in the event of a stuck source. The region may grant 

the licensee an exemption from this requirement provided that the licensee has an 

electrical interlock system, which will retract the source, upon opening access doors to 

the radiation room and commits to its use. In addition, the licensee must commit to 

having an operator present and having a radiation monitor in the room as 

described above.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.23(c), the licensee is exempt 

from having the monitor integrated with personnel access door locks to prevent 

room access when radiation levels are high, based on the commitments 

described in the letter/application dated _______.”

4. 10 CFR 36.23(d) - “Visible and audible alarms to alert people in the radiation room that 

the sources will be moved from their shielded position.”

An acceptable justification is that an audible alarm within the treatment room may cause 

undue distress to nonhuman subjects. If the licensee commits to having a visual alarm 

provided on the outside of the treatment room and to having the operator visually check 

the room before starting treatments, the regions may grant the licensee an exemption.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.23(d), the licensee is exempt

from having an audible alarm within the treatment area, based on the 

commitments described in the letter/application dated _______.”

5. 10 CFR 36.23(f) - “Each radiation room at a panoramic irradiator must contain a control 

that prevents the sources from moving from the shielded position unless the control has 

been activated and the door...has been closed within a preset time...”

Exemptions may be granted to licensees having teletherapy units that are being used for 

irradiation of materials only (no patients), provided that the licensee commits to having

the operator visually verify that the room is not occupied before closing the door, and 

that the converted teletherapy unit (irradiator) activates a visual and audible alarm in the 

teletherapy room for at least 15 seconds before moving the source from the shielded 

position. This visual or audible alarm must be interlocked with the teletherapy unit such 

that the source will not move to the exposed position until the visual or audible alarm has 

been activated and is finished alarming. The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.23(f), the licensee is exempt 

from having a control that prevents the sources from moving from the shielded 

position unless the control has been activated and the door or barrier to the 
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radiation room has been closed within a preset time, based on the commitments 

described in the letter/application dated _______.”

6. 10 CFR 36.27(a) - “The sources must automatically become shielded if a 

fire is detected.”

10 CFR 36.27(b) - “The radiation room at a panoramic irradiator must be equipped with 

a fire extinguishing system capable of extinguishing a fire without entry of personnel. 

The system must have a shutoff valve to control flooding into unrestricted areas.”

The statements of consideration state that the purpose of the fire extinguishing system is 

to prevent a fire from damaging the access control system or preventing the sources 

from being shielded. Most converted teletherapy units are designed to retract the source 

when the electrical power fails, as may occur during a fire. The licensee may be granted 

an exemption from these requirements, provided the licensee commits to the following:

• having smoke detectors, fire extinguishers, and a fire alarm at the site to detect 

and fight small fires

• alerting authorities of the fire

• having a means of measuring the radiation levels in the radiation room during an 

electrical failure

• instructing the operators to retract the source before exiting for a fire involving 

major portions of the facility, provided this action does not jeopardize the 

operator’s safety

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.27(a) and (b), the licensee is 

exempt from (as requested by the licensee), based on the commitments 

described in letter/application dated _______.”

7. 10 CFR 36.31(a) - “The key must be attached to a portable radiation survey meter by a 

chain or cable........The door to the radiation room must require the same key.”

Converted teletherapy units require that the source activation key be inserted into the 

console to provide power to the unit to activate field lights and align the head. 

Therefore, the region may grant the licensee an exemption from this requirement 

provided that the licensee commits to having administrative controls in place to ensure 

that personnel entering the radiation room use a portable survey meter to verify that the 

source has retracted. The licensee must also commit to attach the survey meter to the 

exposure room door key.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.31(a), the licensee is exempt 

from the requirement to have the console key attached to a portable survey 

meter by a chain or cable and that the door to the radiation room require the 

same key, based on the commitments described in the letter/application dated 
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_______. The radiation room door key shall be attached to the portable 

survey meter.”

8. 10 CFR 36.31(b) - “The console of a panoramic irradiator must have a source position 

indicator that indicates when the sources are in...transit.”

In converted teletherapy units, the source is moved nearly instantaneously from the

shielded to the exposed position. Most teletherapy units are designed with two indicator

lights — green indicates the source is in the fully shielded position, red indicates the

source is exposed. During transit both lights are “on,” indicating that the source is in

transit. To require that the licensee install an electronic system to indicate “in transit” for

the period of time the source is in transit, less than a second, does not provide any 

additional protection. Therefore, the region may grant this exemption provided the 

licensee submits a description of its device indicators.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.31(b), the licensee is exempt 

from the requirement to have a separate position indicator to indicate when the 

source is in transit, in accordance with letter/application dated _______.”

9. 10 CFR 36.67(b)(2) - “The irradiator operator...must activate a control in the radiation 

room that permits the sources to be moved from the shielded position only if the door to 

the radiation room is locked within a preset time after setting the control.”

Because of the risk of malfunction associated with alterations to the existing electrical 

interlocks of the teletherapy unit, and considering the licensee’s commitment to 

administratively control access to the room to meet the intent of this regulation, the 

region may grant this exemption, if the licensee demonstrates that a retrofit to install 

such a control would not be possible with the teletherapy unit and a licensee commits to 

the following:

The operator will close the doors immediately upon completion of the visual inspection 

required by 10 CFR 36.67(b)(1).

The operator will verify that each door has locked automatically before stepping to the 

control panel.

The following license condition should be used:

“Notwithstanding the requirements of 10 CFR 36.67(b)(2), the licensee is exempt 

from the requirement to have a control in the radiation room that must be 

activated prior to irradiation, which would not allow the source to be moved from 

the shielded position unless the door to the radiation room is locked within a 

preset time, based on the commitments described in the letter/application dated 

_______.”
APPENDIX P

COMMENCEMENT OF CONSTRUCTION AT EXISTING AND 

PROPOSED BYPRODUCT (INCLUDING IRRADIATORS), 

SOURCE, AND SPECIAL NUCLEAR MATERIAL FACILITIES

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Commencement of Construction at Existing and 

Proposed Byproduct (Including Irradiators), 

Source, and Special Nuclear Material Facilities

PURPOSE AND SCOPE

This appendix applies to all Title 10 of the Code of Federal Regulations (10 CFR) Parts 30 

(byproduct material), 36 (irradiators), 40 (source material) and 70 (special nuclear material 

[SNM]) facilities except for uranium recovery facilities, uranium hexafluoride conversion 

facilities, enrichment facilities, fuel fabrication facilities, uranium hexafluoride deconversion 

facilities, and facilities for SNM of greater than critical mass.

The information in this appendix should be reviewed by all holders of operating licenses for 

byproduct (including irradiators), source, and SNM facilities, and all persons who have 

submitted applications to construct byproduct, source, and SNM facilities, or have submitted 

letters of intent to submit such applications under 10 CFR Parts 30, 36, 40, and 70. 

If a licensing action initiated pursuant to 10 CFR Parts 30, 40, or 70 meets any of the criteria in 

10 CFR 51.20 or 51.21, then commencement of construction of a facility before the NRC staff 

has completed its environmental review process is grounds for denial of the license application, 

in accordance with 10 CFR 30.33(a)(5), 40.32(e), and 70.23(a)(7). However, if the licensing 

action meets the criteria in 10 CFR 51.22(c) for a categorical exclusion, and the NRC has not 

determined that an environmental assessment or an environmental impact statement is required 

in accordance with 10 CFR 51.22(b), then commencement of construction before the NRC staff 

concludes the environmental process should not be the sole basis for denial of the license 

application, as the NRC has already determined that this category of actions does not have a 

significant impact on the environment.

Licensing of irradiators is categorically excluded by 10 CFR 51.22(c)(14)(vii) (an environmental 

review by the NRC is not required). However, under 10 CFR 36.15, commencement of 

construction of a new irradiator may not occur prior to the submission to the NRC of both an 

application for a license for the irradiator and the fee required under 10 CFR 170.31. 

BACKGROUND

The NRC amended its regulations in September 2011, by revising certain provisions applicable 

to the licensing and approval processes for byproduct (including irradiators), source and SNM

licenses in the final rule, “Licenses, Certifications, and Approvals for Materials Licensees” 

(76 FR 56951; September 15, 2011) (Material Licenses Construction Rule). The revisions 

contained in the Material Licenses Construction Rule revised the definitions of “construction” 

and “commencement of construction” for materials licensing actions. 

The definitions of “commencement of construction” in 10 CFR 30.4, 36.2, 40.4, and 70.4 are 

identical. 

Commencement of construction means taking any action defined as “construction” or any other 

activity at the site of a facility subject to the regulations in this part that has a reasonable 

nexus to:

1. Radiological health and safety; or

2. Common defense and security.
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The definitions of “construction” in 10 CFR 30.4, 36.2, and 70.4 are identical. 

Construction means the installation of foundations, or in-place assembly, erection, fabrication, 

or testing for any structure, system, or component of a facility or activity subject to the 

regulations in this part that are related to radiological safety or security. The term “construction” 

does not include: 

1. Changes for temporary use of the land for public recreational purposes;

2. Site exploration, including necessary borings to determine foundation conditions or other 

preconstruction monitoring to establish background information related to the suitability 

of the site, the environmental impacts of construction or operation, or the protection of 

environmental values;

3. Preparation of the site for construction of the facility, including clearing of the site,

grading, installation of drainage, erosion and other environmental mitigation measures,

and construction of temporary roads and borrow areas;

4. Erection of fences and other access control measures that are not related to the safe

use of, or security of, radiological materials subject to this part;

5. Excavation;

6. Erection of support buildings (e.g., construction equipment storage sheds, warehouse

and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and 

office buildings) for use in connection with the construction of the facility;

7. Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility 

and lighting systems, potable water systems, sanitary sewerage treatment facilities, and 

transmission lines);

8. Procurement or fabrication of components or portions of the proposed facility occurring

at other than the final, in-place location at the facility; or

9. Taking any other action that has no reasonable nexus to:

i. Radiological health and safety, or

ii. Common defense and security.

“Construction,” as defined in 10 CFR 40.4, also includes the installation of wells associated with 

radiological operations (e.g., production, injection, or monitoring well networks associated with 

in-situ recovery or other facilities). 

The Atomic Energy Act of 1954, as amended, expressly limits the NRC’s regulatory authority to 

matters concerning the radiological public health and safety or common defense and security 

and non-radiological hazards to the extent such hazards result from the actual processing of byproduct material. The NRC has determined that this authority does not extend to site 

preparation activities that do not have a nexus to radiological health and safety or common 

defense and security.
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This appendix should be used to evaluate whether a particular construction activity has a nexus 

to radiological health and safety, and thus falls under the jurisdiction of the NRC for licensing 

purposes. An activity or action has a reasonable nexus to radiological health and safety or the 

common defense and security if that activity or action has a rational, direct link to ensuring that 

a materials facility is operating, or will operate, in accordance with the NRC’s regulations and in 

a manner that protects the public health and safety or the common defense and security from 

radiological hazards. The definitions of construction in 36.2 lists activities that are not 

considered “construction.” This appendix provides examples of activities that fall under each of

the excepted activities that do not constitute construction. Site preparation activities that are not 

considered “construction,” while not under NRC jurisdiction may be subject to the regulatory 

authority of another Federal, State, or local agency which may require National Environmental 

Policy Act or state environmental review. NRC’s responsibilities under the National Historic 

Preservation Act of 1966, as amended (NHPA), must also be satisfied before a license is 

issued. Specifically, as noted in the statements by the NRC published with the final Material 

Licenses Construction Rule, under certain circumstances the NRC may be required to deny a 

license application if the NRC determines that the applicant intentionally significantly adversely 

affected, or allowed to be affected, a historic property with intent to avoid the requirements of 

§106 of the NHPA. 

DISCUSSION OF EXAMPLES

In addition to the background discussion provided above, the following examples clarify the 

delineation of site preparation activities and construction activities. It is important to recognize 

that the NRC may have regulatory authority over activities that can occur before construction 

begins, such as procurement of basic components as defined in 10 CFR Part 21, the process of 

dedicating commercial grade items or basic components, or procurement of items relied on for 

safety (IROFS) as defined in 10 CFR Part 70. It should also be noted that, while site 

preparation activities may not require prior NRC approval, various local, State, or other Federal 

permits may be required.

BYPRODUCT MATERIAL (10 CFR PART 30)

Prior to the conclusion of the environmental review process, applicants for byproduct material 

licenses or license amendments should not perform construction activities that have a nexus to 

radiological health and safety or the common defense and security. An activity or action has a 

reasonable nexus to radiological health and safety or the common defense and security if that 

activity or action has a rational, direct link to ensuring that a licensed materials facility is 

operating, or will operate, in accordance with the NRC’s regulations and in a manner that 

protects the public health and safety or the common defense and security from 

radiological hazards.

Installation of foundations or in-place assembly, erection, fabrication, or testing for any structure, 

system, or component of a facility or activity subject to 10 CFR Part 30 that are related to 

radiological health and safety or common defense and security should not be performed prior to 

the conclusion of the environmental review of a license application or amendment. Byproduct 

material license applicants subject to 10 CFR Part 30 may perform those site preparation 

activities identified in revised 10 CFR 30.4 before the NRC has completed its environmental 

review of the license application.

Excavation and other site preparation activities that do not have a reasonable nexus to 

radiological public health and safety or common defense and security, whether permanent or 
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temporary, are not “construction” activities. For example, piles driven to support the erection of 

a bridge for a temporary or permanent access road to a new facility would not be considered as 

construction and may be performed prior to the NRC staff concluding its environmental review 

of a proposed action.

The installation of a temporary feature within an excavation for a building in which materials 

license activities will be conducted and that will be removed during construction is a site 

preparation activity. Such features include retaining walls, dewatering systems, ramps, and 

other structures that will have no physical presence following construction.

Construction includes installation of the foundation, including soil compaction; the installation of 

permanent drainage systems and geofabric; the placement of backfill, concrete (e.g., mudmats), 

or other materials that will not be removed before placement of the foundation of a structure; the 

placement and compaction of a subbase; the installation of reinforcing bars to be incorporated 

into the foundation of the structure; the erection of concrete forms for the foundations that will 

remain in place permanently (even if nonstructural); and the placement of concrete or other 

material constituting the foundation of any safety-related feature.

The term “permanent” in this context includes anything that will exist in its final, in-place facility 

location after commencement of operations with licensed material. Construction also includes 

the “onsite, in-place” fabrication, erection, integration, or testing activities for any in-scope 

safety-related equipment. The terms “onsite, in place, fabrication, erection, integration, or 

testing” describe the process of constructing a facility in its final, onsite plant location, where 

components or modules are integrated into the final, in-plant location. The fabrication, 

assembly, and testing of components and modules in a shop building, warehouse, or laydown 

area, even if located onsite, is not construction. However, the installation or integration of the 

safety-related equipment into its final plant location is construction.

Construction also includes driving piles for safety-related equipment. Hence, an applicant must 

obtain a license before driving piles for safety-related equipment. However, driving piles that do 

not ensure the structural stability or integrity of a safety-related structure (e.g., piles driven to 

support the erection of a bridge for a temporary or permanent access road) is not construction; 

therefore, those piles may be driven prior to the NRC staff concluding its environmental review 

of a proposed action.

IRRADIATORS (10 CFR PART 36)

An applicant for a new irradiator license under 10 CFR Part 36 may perform the nonconstruction activities identified in revised 10 CFR 36.2 at any time. However, installation of 

foundations or in-place assembly, erection, fabrication, or testing for any structure, system, or 

component of a facility or activity subject to 10 CFR Part 36 that have a reasonable nexus to 

radiological safety or security should not be performed prior to the submission of an application 

for a license and the fee required by 10 CFR 170.31. An activity or action has a reasonable 

nexus to radiological health and safety or the common defense and security if that activity or 

action has a rational, direct link to ensuring that a licensed materials facility is operating, or will 

operate, in accordance with the NRC’s regulations and in a manner that protects the public

health and safety or the common defense and security from radiological hazards. Activities that 

have a reasonable nexus to radiological health and safety or common defense and security 
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include, but are not limited to, construction of systems subject to 10 CFR Part 36, Subpart C, 

and the following: 

• earthwork

• pool excavation

• footings and foundation for pool

• irradiator foundations and walls

• backfill pool

• install pool liner

• mechanical rough-in

• electrical rough-in

• shoring for roof

• form and place roof

• slab on grade

Subpart C of 10 CFR Part 36 lists the systems that have a nexus to radiological health and 

safety and defines the related engineering and safety concerns associated with each system:

• Access Control: adequacy of access control systems using interlocks and radiation 

monitors to prevent inadvertent entry to areas where radiation sources are unshielded 

to provide emergency exits; and to ensure compliance with all the requirements of 

10 CFR 36.23; (For computer-controlled access-control systems, licensing staff should 

consider expert evaluation of the software/system logic before operational testing.)

• Site: potential need for protection against flooding and earth slides.

• Base (soil, rock) for the Pool and Shielding Structures: strength, settlement, liquefaction, 

ground water, and soil compaction

• Footers and Foundations for the Pool and Shielding Structures: strength and 

reinforcement, alignment with pool and shielding structures

• Pool and Shielding Structures: strength and reinforcement, proper density of shielding 

materials, correct dimensions, minimization of voids in concrete or other shielding

• Pool Liner: contact with pool structure, penetrations in the liner, leak-tight welds

• Pool Plumbing: makeup water system; water cleanup system; effect of construction 

materials on pool-water chemistry; drainage system (potentially contaminated spilled 

water should flow into the pool); siphon breakers; radiation detection and alarm systems

• Penetrations Through Shielding: any significant effect on structural strength, shielding, 

or both.

• Source Rack Protection (if the product to be irradiated moves on a product conveyor 

system): source rack and the mechanism that moves the rack must be protected by a 

barrier or guides to prevent products and product carriers from hitting or touching the 

rack or mechanism.
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• Source-Rack Mechanical Positioning System: strength and stiffness of the rack and 

positioning cables or chains, source shroud will not interfere with source positioning, 

adequacy of motive power, potential for jamming.

• Source-Rack Movement and Position-Sensing System: structural attachments for 

electrical and mechanical transducers, adequacy of transducers for interacting with the 

source-rack control system.

• Source-Rack Electrical Control System: adequacy of the design of logistical and 

operational electrical circuitry and electromechanical components, to ensure 

unambiguous response of the system, which includes programmable controllers or 

computers and their interaction with operations, interlocks, doors, signals, and alarms.

• Source-Leak Detection: adequacy of systems for detecting and isolating 

leaking sources.

• Hard Wiring: adequacy of wire gauge and insulation to safely carry design currents and 

to withstand radiation and ozone damage if exposed; locating and attaching wiring to 

prevent fretting, wear, and exposure to potential fire hazards; accessibility to wiring for 

inspection and repair.

• Uninterruptable Electrical Power Supply: adequate and reliable power capability to 

operate all electrical systems that are important to safety (including backup power 

sources); compatibility of the power supply with the electrical system.

• Fire Protection System: adequacy to detect fire and smoke and to be manually as well 

as automatically initiated; must ensure that raised sources are immediately lowered into 

the pool.

• Emergency Systems for Returning an Up-stuck Source Rack to the Pool: capability of 

the electrical control system to sense and signal the occurrence of an up-stuck sourcerack; adequacy of mechanical or electrical means for personnel to safely release and 

lower the rack; need for, and adequacy of, a system to cool the source-rack until it can 

be released and lowered.

• Ozone Ventilation System: capability of the system to be properly initiated and to 

provide adequate volume flow rate of air to protect personnel and components.

• System for Transferring Sources from and to Transport Vehicles: adequately sized 

openings in the shield-structure roof if sources are roof-loaded; structural adequacy of 

the roof-shield plug and its supports for its removal and replacement; structural and 

mechanical adequacy of systems for moving shipping containers into and out of the 

pool area.

ACTIVITIES WHICH HAVE NO REASONABLE NEXUS TO RADIOLOGICAL SAFETY 

OR SECURITY

The NRC has determined that, in general, the following activities at byproduct (including 

irradiators), source, and SNM facilities listed in 10 CFR 30.4, 36.2, 40.4, and 70.4, do not have 

a reasonable nexus to radiological health and safety and the common defense and security may 

be performed by a licensee or applicant at any time. Note that in some circumstances, based 
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on the specific licensing proposal, any of these activities could be determined to have a 

reasonable nexus to radiological health and safety or common defense and security and, based 

on that determination, these activities would be construction:

1. Changes for temporary use of the land for public recreational purposes;

2. Site exploration, including necessary borings to determine foundation conditions or other 

preconstruction monitoring to establish background information related to the suitability 

of the site, the environmental impacts of construction or operation, or the protection of 

environmental values;

3. Preparation of the site for construction of the facility, including clearing of the site,

grading, installation of drainage, erosion and other environmental mitigation measures,

and construction of temporary roads and borrow areas;

4. Erection of fences and other access control measures that are not related to the safe

use of, or security of, radiological materials subject to 10 CFR Parts 30, 36, 40, or 70;

5. Excavation;

6. Erection of support buildings (e.g., construction equipment storage sheds, warehouse

and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and 

office buildings) for use in connection with the construction of the facility;

7. Building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility 

and lighting systems, potable water systems, sanitary sewerage treatment facilities, and 

transmission lines);

8. Procurement or fabrication of components or portions of the proposed facility occurring

at other than the final, in-place location at the facility; or

9. Taking any other action that has no reasonable nexus to:

i. Radiological health and safety, or

ii. Common defense and security.

While the above site preparation activities may not require prior NRC approval, other Federal, 

State, or Local permits may be required. 

REFERENCES 

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

Materials Facilities,” August 2003

• DC/COL–ISG–4, “Interim Staff Guidance on the Definition of Construction and on 

Limited Work Authorizations,” February 9, 2009, ML082970729

APPENDIX Q

SAFETY CULTURE POLICY STATEMENT 

Q–1

Safety Culture

The safety culture policy statement was published in the Federal Register (76 FR 34773) on 

June 14, 2011 and can be found at: https://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-

14656.pdf. It is also posted in the U.S. Nuclear Regulatory Commission’s (NRC’s) Agencywide 

Documents Access and 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.
Q–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, and

9. Questioning Attitude—Individuals avoid complacency and continuously challenge 

existing conditions and activities in order to identify discrepancies that might result in 

error or inappropriate action.

There may be traits not included in this Statement of Policy that are also important in a positive 

safety culture. It should be noted that these traits were not developed to be used for 

inspection purposes.

It is the Commission’s expectation that all individuals and organizations, performing or 

overseeing regulated activities involving nuclear materials, should take the necessary steps to 

promote a positive safety culture by fostering these traits as they apply to their organizational 

environments. The Commission recognizes the diversity of these organizations and 

acknowledges that some organizations have already spent significant time and resources in the 

development of a positive safety culture. The Commission will take this into consideration as 

the regulated community addresses the Statement of Policy.
APPENDIX R

CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)

R–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. 6

Revision 1, Final

Consolidated Guidance About Materials Licenses: Program-Specific

Guidance About 10 CFR Part 36 Irradiator Licenses