Consolidated Guidance 

about Materials Licenses

Program-Specific Guidance about 

Academic, Research and Development,

and Other Licenses of Limited Scope

Including Electron Capture Devices

And X-Ray Fluorescence Analyzers

Draft Report for Comment

Office of Federal and State Materials and

Environmental Management Programs

NUREG-1556

Volume 7, Rev. 1
NRC Reference Material 

As of November 1999, you may electronically access 

NUREG-series publications and other NRC records at 

NRC’s Public Electronic Reading Room at 

http://www.nrc.gov/reading-rm.html. Publicly released 

records include, to name a few, NUREG-series 

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NRC publications in the NUREG series, NRC 

regulations, and Title 10, “Energy,” in the Code of

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AVAILABILITY OF REFERENCE MATERIALS

IN NRC PUBLICATIONS

Legally binding regulatory requirements are stated only 

in laws; NRC regulations; licenses, including technical 

specifications; or orders, not in NUREG-series 

publications. The views expressed in contractorprepared publications in this series are not necessarily 

those of the NRC.

The NUREG series comprises (1) technical and 

administrative reports and books prepared by the staff 

(NUREG–XXXX) or agency contractors (NUREG/CR–

XXXX), (2) proceedings of conferences (NUREG/CP–

XXXX), (3) reports resulting from international 

agreements (NUREG/IA–XXXX), (4) brochures 

(NUREG/BR–XXXX), and (5) compilations of legal 

decisions and orders of the Commission and Atomic and 

Safety Licensing Boards and of Directors’ decisions

under Section 2.206 of NRC’s regulations (NUREG–

0750).

DISCLAIMER: This report was prepared as an account 

of work sponsored by an agency of the U.S. 

Government. Neither the U.S. Government nor any 

agency thereof, nor any employee, makes any warranty, 

expressed or implied, or assumes any legal liability or 

responsibility for any third party’s use, or the results of 

such use, of any information, apparatus, product, or 

process disclosed in this publication, or represents that 

its use by such third party would not infringe privately 

owned rights.
Consolidated Guidance 

about Materials Licenses

Program-Specific Guidance about 

Academic, Research and Development,

and Other Licenses of Limited Scope

Including Electron Capture Devices

And X-Ray Fluorescence Analyzers

Draft Report for Comment

Manuscript Completed: December 2013

Date Published: January 2014

Prepared by: 

K. Avery

M. Hammond

S. Hawkins

B. Parker

B. Ullrich

Office of Federal and State Materials and

 Environmental Management Programs

 

NUREG-1556

Volume 7, Rev. 1
COMMENTS ON DRAFT REPORT

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

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

specify the report number NUREG-1556, Volume 7, Revision 1, in your comments, and send 

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

availability of this report. 

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

Docket ID NRC-2014-0005 in the subject line of your comments. Comments submitted in 

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

website http://www.regulations.gov. 

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

filed under Docket ID NRC-2014-0005. Address questions about NRC dockets to Carol 

Gallagher at 301-287-3422 or by e-mail at Carol.Gallagher@nrc.gov. 

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

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

3WFN-06-A44MP, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

For any questions about the material in this report, please contact: Tomas Herrera, Sr. Project 

Manager at 301-415-7138 or by e-mail at Tomas.Herrera@nrc.gov. 

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

record and entered into the Agencywide Documents Access and Management System 

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

NUREG-1556, Volume 7, Revision 1, has been 

reproduced from the best available copy.
iii

ABSTRACT

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

assist applicants and licensees in preparing applications for materials licenses for academic, 

research and development, and other licenses of limited scope (ARDL). 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.

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 collection requirements 

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

3150-0017, 3150-0038, 3150-0001, 3150-0010, 3150-0020, and 3150-0009.

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

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

currently valid OMB control number.

Paperwork Reduction Act Statement

Public Protection Notification

v

FOREWORD

The U.S. Nuclear Regulatory Commission’s (NRC’s) NUREG-1556 technical report series 

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

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

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

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

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

Volume No. Volume Title

1 Program-Specific Guidance about Portable Gauge Licenses

2 Program-Specific Guidance about Industrial Radiography Licenses

3 Applications for Sealed Source and Device Evaluation and Registration

4 Program-Specific Guidance about Fixed Gauge Licenses

5 Program-Specific Guidance about Self-Shielded Irradiator Licenses

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

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

Other Licenses of Limited Scope 

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
vi

Volume No. Volume Title

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 Program-Specific Guidance about Administrative Licensing Procedures

21 Program-Specific Guidance about Possession Licenses for Production of 

Radioactive Materials Using an Accelerator

22 Reserved

The current document, NUREG-1556, Volume 7, Revision 1, “Consolidated Guidance about 

Materials Licenses: Program-Specific Guidance about Academic, Research and Development, 

and Other Licenses of Limited Scope Including Electron Capture Devices and X-Ray 

Fluorescence Analyzers,” 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 7, issued December 1999.

This report takes a risk-informed, performance-based approach to licensing academic, research 

and development, and other licenses of limited scope (ARDL). 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 ARDL users. 

NUREG-1556, Volume 7, Revision 1, is not a substitute for NRC 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 continue a license.

_________________________________________

Laura A. Dudes, Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and Environmental Management Programs
vii

CONTENTS

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

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

FIGURES AND TABLES...........................................................................................................ix

ACKNOWLEDGMENTS............................................................................................................xi

ABBREVIATIONS ...................................................................................................................xiii

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

2. AGREEMENT STATES ........................................................................................................5

3. MANAGEMENT RESPONSIBILITY......................................................................................9

3.1 Commitments and Responsibilities ...............................................................................9

3.2 Safety Culture ............................................................................................................10

4. APPLICABLE REGULATIONS...........................................................................................13

5. HOW TO FILE.....................................................................................................................15

5.1 Paper Application .......................................................................................................15

5.2 Where to File .............................................................................................................15

5.3 Transfer to Electronic Format .....................................................................................16

6. IDENTIFYING AND PROTECTING SENSITIVE INFORMATION .......................................17

7. APPLICATION AND LICENSE FEES.................................................................................19

8. CONTENTS OF AN APPLICATION ...................................................................................21

8.1 ITEM 1: License Action Type.....................................................................................22

8.2 ITEM 2: Applicant’s Name and Mailing Address ........................................................22

8.2.1 Notification of Bankruptcy Proceedings ........................................................22

8.3 ITEM 3: Address(es) Where Licensed Material Will Be Used or Possessed ..............23

8.4 ITEM 4: Person to Be Contacted about this Application.............................................24

8.5 ITEM 5: Radioactive Material.....................................................................................24

8.5.1 Unsealed or Sealed Byproduct Material .......................................................24

8.5.2 Financial Assurance and Recordkeeping for Decommissioning.................28

8.6 ITEM 6: Purpose(s) for which Licensed Material Will Be Used...................................32

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

their Training and Experience.......................................................................34

8.7.1 Radiation Safety Officer (RSO) ....................................................................34

8.7.2 Authorized User ..........................................................................................37

8.8 ITEM 8: Training for Individuals Working in or Frequenting Restricted Areas

 (Occupationally Exposed Individuals and Ancillary Personnel) ....................39

8.9 ITEM 9: Facilities and Equipment ..............................................................................40

8.10 ITEM 10: Radiation Safety Program ..........................................................................42

8.10.1 Audit Program............................................................................................42

8.10.2 Radiation Monitoring Instruments.................................................................44

8.10.3 Material Receipt And Accountability .............................................................47

8.10.4 Occupational Dose ......................................................................................53
viii

8.10.5 Public Dose...............................................................................................56

8.10.6 Safe Use of Radionuclides and Emergency Procedures ..............................58

8.10.7 Surveys........................................................................................................62

8.10.8 Transportation..............................................................................................67

8.10.9 Security Program for Category 1 and Category 2 Materials .........................68

 8.11 ITEM 11: Waste Management ...................................................................................69

8.12 ITEM 12: License Fees..............................................................................................74

8.13 ITEM 13: Certification ................................................................................................75

9. AMENDMENTS AND RENEWALS TO A LICENSE...........................................................77

9.1 Timely Notification of Transfer of Control....................................................................77

10. APPLICATIONS FOR EXEMPTIONS................................................................................79

11. TERMINATION OF ACTIVITIES........................................................................................81

APPENDICES

APPENDIX A LIST OF DOCUMENTS CONSIDERED IN DEVELOPMENT OF THIS 

NUREG .......................................................................................................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 NRC FORM 313 ..................C-1

APPENDIX D ELECTRON CAPTURE DETECTORS AND X-RAY FLUORESCENCE 

ANALYZER APPLICATIONS.......................................................................D-1

APPENDIX E GUIDANCE FOR LABORATORY ANIMAL AND VETERINARY 

MEDICINE USES ........................................................................................E-1

APPENDIX F RADIATION SAFETY OFFICER DUTIES AND RESPONSIBILITIES.......... F-1

APPENDIX G RADIATION SAFETY TRAINING TOPICS ..................................................G-1

APPENDIX H FACILITIES AND EQUIPMENT CONSIDERATIONS ..................................H-1

APPENDIX I SAMPLE AUDIT PROGRAM........................................................................ I-1

APPENDIX J RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND 

MODEL SURVEY INSTRUMENT AND AIR SAMPLER CALIBRATION 

PROGRAM...................................................................................................J-1

APPENDIX K MATERIAL RECEIPT AND ACCOUNTABILITY ..........................................K-1

APPENDIX L PUBLIC DOSE .............................................................................................L-1

APPENDIX M GENERAL TOPICS FOR SAFE USE OF RADIONUCLIDES 

AND MODEL EMERGENCY PROCEDURES .............................................M-1

APPENDIX N RADIATION SAFETY SURVEY TOPICS.....................................................N-1

APPENDIX O MODEL LEAK TEST PROCEDURES..........................................................O-1

APPENDIX P TRANSPORTATION REQUIREMENTS ......................................................P-1

APPENDIX Q MODEL WASTE MANAGEMENT PROCEDURES......................................Q-1

APPENDIX R INTERIM STAFF GUIDANCE ON CONSTRUCTION ..................................R-1

APPENDIX S SAFETY CULTURE STATEMENT OF POLICY...........................................S-1
ix

FIGURES

Figure 2.1 U.S. Map.................................................................................................................5

Figure 8.1 Methods of Certification of Financial Assurance for Decommissioning..................30

Figure 8.2 Types of Records that Must Be Maintained for Decommissioning.........................31

Figure 8.3 Typical Duties and Responsibilities of RSOs ........................................................35

Figure 8.4 Authorized User....................................................................................................38

Figure 8.5 Examples of Portable Instruments Used in Laboratory Settings............................45

Figure 8.6 Material Receipt and Accountability. .....................................................................49

Figure 8.7 Annual Dose Limits for Occupationally Exposed Individuals .................................54

Figure 8.8 Calculating Public Dose........................................................................................57

Figure 8.9 Use of Appropriate Shielding ................................................................................59

Figure 8.10 Proper Handling of Incident...................................................................................62

Figure 8.11 Types of Surveys ..................................................................................................63

Figure 8.12 Personnel Surveys................................................................................................64

Figure M.1 Storage of Food and Drink..................................................................................M-2

Figure N.1 Laboratory Layout...............................................................................................N-7

TABLES

Table 2.1 Who Regulates the Activity? ...................................................................................6

Table 3.1 Traits of a Positive Safety Culture.........................................................................12

Table 8.1 Commonly Used Unsealed Licensed Materials Requiring Financial 

Assurance and Decommissioning Funding Plan ...................................................30

Table 8.2 Sample Format for Providing Information about Requested Radionuclides...........32

Table 8.3 Package Monitoring Requirements .......................................................................48

Table 8.4 Record Maintenance.............................................................................................51

Table A.1 List of Documents Considered in the Preparation of this Report .........................A-1

Table J.1 Typical Survey Instruments..................................................................................J-1

Table L.1 Standard Occupancy Factors...............................................................................L-3

Table N.1 Suggested Contamination Survey Frequency .....................................................N-3

Table N.2 Acceptable Surface Contamination Levels for Equipment...................................N-3

Table N.3 Screening Values for Building Surface Contamination ........................................N-4

xi

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 NRC and all of the 

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

this report.

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

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

The Participants for this Revision:

Avery, Kayla

Chidakel, Susan

Coggins, Angela

Hammond, Michelle

Hawkins, Sarenee

Houseman, Esther

Parker, Bryan

Ullrich, Betsy 

xiii

ABBREVIATIONS

ALARA as low as is reasonably achievable

ALI annual Limit of Intake

AMAD activity median aerodynamic diameter

ANSI American National Standards Institute

ARDL academic, research and development, and other licenses

AU authorized user

bkg background

BPR business process redesign

Bq becquerel

CDE committed dose equivalent

CEDE committed effective dose equivalent

CD-ROM compact disk-read only memory 

CFR Code of Federal Regulations

Ci curie

cpm counts per minute

DAC derived air concentration

DCF dose conversion factor

DDE deep dose equivalent

DFP Decommissioning Funding Plan

DIS decay-in-storage

DOE United States Department of Energy

DOT United States Department of Transportation

dpm disintegrations per minute

dps disintegrations per second

ECD electron capture detector

EDE effective dose equivalent

EPA U.S. Environmental Protection Agency

F/A financial Assurance

FR Federal Register

GBq gigabecquerel

GC gas chromatograph

G-M Geiger-Mueller

GPO Government Printing Office

Gy gray

IAEA International Atomic Energy Agency

ICRP International Commission on Radiological Protection

IN Information Notice

LLW low-level radioactive waste

LSA low specific activity

LSC liquid scintillation counter

MBq megabequerel

mCi millicurie

mGy milligray

ml milliliter

mR milliroentgen
xiv

mrem millirem

mSv millisievert

uCi microcurie

uR microroentgen

NaI sodium iodide

NCRP National Council on Radiation Protection and Measurements

NIST National Institute of Standards and Technology

NMSS Office of Nuclear Material Safety and Safeguards

NRC United States Nuclear Regulatory Commission

NVLAP National Voluntary Laboratory Accreditation Program

OCFO Office of the Chief Financial Officer

OCR optical character reader

OMB Office of Management and Budget

OSL optically-stimulated luminescence dosimeter

OSP Office of State Programs

P&GD policy and guidance directive 

R roentgen

RAM radioactive material

RG regulatory guide

RPO radiation protection officer

RQ reportable quantities

RSO radiation safety officer

SDE shallow dose equivalent

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

Internationale d’Unites)

SSD sealed source and device

std standard

Sv sievert

TEDE total effective dose equivalent

TI Transportation Index

TLD thermoluminescence dosimeters

TODE total organ dose equivalent

UN United Nations

XRF X-ray fluorescence (analyzer)
1

1. PURPOSE OF REPORT

This report provides guidance to an applicant in preparing an academic, research and 

development, and other licenses of limited scope (ARDL) application for use of unsealed 

radioactive materials in laboratory studies or similar activities, veterinary uses of licensed 

materials, and small sealed sources such as in electron capture devices (ECDs) and X-ray

fluorescence analyzers (XRF). This report also provides the U.S. Nuclear Regulatory 

Commission (NRC) criteria for evaluating the license application. It is not intended to address 

licenses of broad scope, licenses for manufacturing and distribution of byproduct material, or 

licenses for the use of large sealed sources and devices. Within this document, the phrases or 

terms, “byproduct material,” “licensed material,” or “radioactive material,” are used 

interchangeably.

This document is designed for applicants to use in applying for a specific license of limited 

scope that the Commission issues under Title 10 of the Code of Federal Regulations (10 CFR)

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

characterized by a listing of the following specific items:

• radionuclides

• chemical and physical form

• possession Limits

• radiation safety officer

• authorized users

• authorized locations

Byproduct material, as defined in 10 CFR 30.4, “Definitions,” is used for a variety of purposes in 

research, industry, and other fields. The following are typical uses:

• in vivo studies (labeling cells, studies involving animals, excluding humans)

• in vitro studies

• analytical work and studies, including use of ECDs and XRFs

• veterinary medicine

• calibration of applicant’s instruments

• field studies.

The NRC’s past practice was to issue a separate license to authorize the possession and use of 

other types of radioactive materials, such as source material and special nuclear material, and 

larger sealed sources such as self-shielded irradiators. However, the NRC will now allow many 

self-shielded irradiators and other such materials to be listed on a single license. Applicants 

for additional materials should use the appropriate guidance documents to submit the 

information needed to support the requested activities, such as NUREG-1556, Vol. 5, 

“Consolidated Guidance about Materials Licenses: Program-Specific Guidance about SelfShielded Irradiator Licenses,” which provides guidance on licensing self-shielded irradiators.

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

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

byproduct material for ARDL applicants. The Office of Management and Budget (OMB) has 
2

approved the information collection requirements in 10 CFR Part 20, “Standards for Protection 

Against Radiation,” 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of 

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

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

Containing Byproduct Material,” and NRC Form 313 under OMB Clearance Nos. 3150-0014, 

3150-0017, 3150-0016, 3150-0001, and 3150-0120, respectively.

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

• Regulations—references the regulations applicable to the item

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

• Discussion—provides additional information about the topic

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

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

licensing process

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

Form 313.

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 convenience 

and streamlined handling of portable gauge applications, Appendix B, “Suggested Format for 

Providing Information Requested in Items 5 through 11 of NRC Form 313,” may be used to 

provide supporting information.

Appendix C is a checklist that the NRC staff uses to review applications and applicants can 

use to check for completeness. Appendices E through S contain additional information on 

various radiation safety topics. 

Appendix D provides specific guidance for licensing sealed sources in devices such as 

electron capture detectors (ECDs) used in gas chromatographs or chemical detectors and XRay fluorescence analyzers (XRFs) and may be used independently from Volume 7 for 

requesting a license only for these devices.

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

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

dose equivalent (TEDE), as defined in 10 CFR Part 20. Rem and its International System of 

Units (SI) equivalent, sievert (Sv) (1 rem = 0.01 Sv), are used to describe units of radiation 

exposure or dose. This is done because 10 CFR Part 20 sets dose limits in terms of rem

(sievert), rather than rad or roentgen. 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 
3

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.

5

2. AGREEMENT STATES

Certain States, called Agreement States (see Figure 2.1), have entered into agreements with 

the 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 land to determine whether the NRC or the Agreement 

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

Indian tribes.

1

 

 1

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

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

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

 www.bia.gov.
6

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

while the Agreement State has 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. The NRC recommends that applicants 

contact their local office of the Federal agency controlling the site (e.g., contract officer, base 

environmental health officer, district office staff) for assistance in determining the jurisdictional 

status of the land and to provide the information in writing to ensure compliance with NRC or 

Agreement State regulatory requirements, as appropriate. Additional guidance on determining 

jurisdictional status is found in the Office of Federal and State Materials and Environmental 

Management Program’s (FSME) procedures in the State Agreement (SA) series, SA-500, 

“Jurisdiction Determination,” which is available at http://nrc-stp.ornl.gov/. Once on the Web site, 

use the link for “FSME Procedures” in the left hand column under “Resources & Tools.” The link 

will take you to another Web page where you can search for FSME Procedures.

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 the U.S. Department of 

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

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

material under certain Department of Energy and Nuclear Regulatory 

Commission contracts”)

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 NRC2

Federally recognized Indian Tribe or tribal member outside of Indian Tribal 

land in Agreement State. Agreement State

 2 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 are few 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.
7

Applicant and Proposed Location of Work Regulatory 

Agency

Non-Federal entity in Agreement State Agreement 

State3

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

subject to exclusive Federal jurisdiction

Agreement 

State3

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 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 Part 50 or 52 reactor operations or needed during the 

construction and preoperational phases of a reactor.

Agreement 

State3

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

numbers of responsible officials) is available at the Office of Federal and State Materials and

Environmental Management Programs’ public Web site, http://nrc-stp.ornl.gov. As an

alternative, a request for the list can be made to an NRC regional office.

 3

 Section 274m. of the AEA gives the NRC regulatory authority over radioactive materials covered under the

 Section 274b. Agreement 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 at a site.

 (This is an uncommon situation which NRC usually evaluates on a case-by-case basis.) Companies that wish to

 possess or use licensed material at these sites should contact the licensee to determine the jurisdictional status

 for specific AEA radioactive materials they intend to possess or use at the site.

9

3. MANAGEMENT RESPONSIBILITY

The NRC recognizes that effective radiation safety program management is vital for 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 10 CFR 30.32(c), each application shall be signed by the applicant or licensee or a 

person duly authorized to act for and on the 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 that signed the application is duly authorized to act for and on the behalf of the 

applicant or licensee. The signature on an application acknowledges the 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;

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

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

public and workers are protected from radiation hazards and compliance with

regulations is maintained;

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

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

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

and responsibilities;

• Commitment to ensure that radiation workers have adequate training;

• Prevention of discrimination of employees engaged in protected activities (10 CFR 30.7, 

“Employee protection”);
10

• Commitment to provide information to employees about the employee protection and 

deliberate misconduct provisions in 10 CFR 30.7 and 10 CFR 30.10, “Deliberate

misconduct,” respectively;

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

license (see Section 9.1, “Timely Notification of Transfer of Control,” of this report); and

• 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 

report.

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

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

the NRC’s online library at http://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.
11

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. For instance, licensees who handle unsealed materials must perform surveys to 

identify skin contamination so that prompt actions may be taken to minimize the dose to the 

individual and reduce the spread of the contamination. The need to perform the personnel 

surveys may correspond with the safety culture trait specified in Table 3.1 as “Work Processes” 

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

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

consider reviewing their radiation safety programs and develop and implement a safety culture 

commensurate with the nature and complexity of their organizations and functions.

Refer to Appendix S for the NRC’s safety culture policy statement. More information on NRC 

activities relating to safety culture can be found at: http://www.nrc.gov/aboutnrc/regulatory/enforcement/safety-culture.html.
12

Table 3.1 Traits of a Positive Safety Culture

Leadership Safety Values 

and Actions 

Problem Identification and 

Resolution Personal Accountability 

Leaders demonstrate a 

commitment to safety in their 

decisions and behaviors 

Issues potentially impacting 

safety are promptly 

identified, fully evaluated, 

and promptly addressed and 

corrected commensurate 

with their significance 

All individuals take personal 

responsibility for safety 

Work Processes Continuous Learning 

Environment for Raising 

Concerns 

The process of planning and 

controlling work activities is 

implemented so that safety 

is maintained 

Opportunities to learn about 

ways to ensure safety are 

sought out and implemented 

A safety conscious work 

environment is maintained 

where personnel feel free to 

raise safety concerns without 

fear of retaliation, 

intimidation, harassment or 

discrimination 

Effective Safety 

Communications 

Respectful Work 

Environment Questioning Attitude 

Communications maintain a 

focus on safety 

Trust and respect permeate 

the organization 

Individuals avoid 

complacency and 

continuously challenge 

existing conditions and 

activities in order to identify 

discrepancies that might 

result in error or 

inappropriate action 
13

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 the use of licensed material by 

ARDL licensees. These parts will apply to many, if not all, licensees.

The current versions of these parts can be found under the “Basic References” link at the NRC’s 

online library at http://www.nrc.gov/reading-rm.html; if viewing in a browser, the following list 

includes direct links to the rules:

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

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

Investigations”

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

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

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

Material”

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

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

Containing Byproduct Material”

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

Quantities of Radioactive Material”

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

• 10 CFR Part 51, “Environmental Protection Regulations for Domestic Licensing and 

Related Regulatory Functions”

• 10 CFR Part 70, “Domestic Licensing of Special Nuclear 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”
14

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

order desk toll-free at (866) 512-8600, in Washington, DC, at (202) 512-1800 or online at 

http://bookstore.gpo.gov.

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

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

NRC regulations and amendments can also be accessed from the “NRC Library” link on the 

NRC’s public Web site at http://www.nrc.gov. The NRC and all other Federal agencies publish 

amendments to their regulations in the Federal Register.
15

5. HOW TO FILE

5.1 Paper Application

Applicants for a materials license should do the following:

• Use the most recent guidance in preparing an application.

• Complete NRC Form 313 (Appendix B) Items 1 through 4, 12, and 13 on the form itself.

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

Appendix C.

• 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 submitted with the 

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

application or the topic to which it refers.

• Submit all documents, typed, on 8-1/2 x 11-inch paper.

• Avoid submitting proprietary information and personally identifiable information.

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

privacy and security related) should be clearly identified per 10 CFR 2.390, “Public 

inspections, exemptions, requests for withholding” (see Chapter 6, “Identifying and 

Protecting Sensitive Information”). 

 

• Submit an original, signed application.

• Retain one copy of the license application for future reference.

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”).

5.2 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.
16

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.

5.3 Transfer to Electronic Format

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 printed or typewritten—not handwritten—text on smooth, crisp paper that will 

feed easily into the scanner.

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

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

• Use 12-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).

The NRC will provide additional instructions as the agency implements new mechanisms for

electronic license application filing.
17

6. IDENTIFYING AND PROTECTING SENSITIVE INFORMATION

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

available for review in the NRC’s Public Document Room and electronically at the NRC Library. 

For more information on the NRC Library, visit www.nrc.gov.

The licensee should identify, mark, and protect sensitive information against unauthorized 

disclosure to the public. Licensing applications that contain sensitive information should be 

marked as indicated below in accordance with 10 CFR 2.390 before the information is submitted 

to the NRC. Key examples are as follows:

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

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

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

substantial delays in processing the application.

• 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, which can be found on the 

NRC’s Generic Communications webpage under “Regulatory Issue Summaries”: 

http://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 release of information that terrorists could use to plan or 

execute an attack against facilities or citizens in the United States. 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, 

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

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

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

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

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

information on procedures and any updates is available at http://www.nrc.gov/readingrm/sensitive-info.html.

19

7. APPLICATION AND LICENSE FEES

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

Refer to 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 

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 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.”

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

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

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

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

21

8. CONTENTS OF AN APPLICATION

The following comments apply to the indicated items on NRC Form 313 (Appendix B).

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

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 must 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.

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 concepts and 

philosophy. The application should document ALARA considerations, including establishing 

administrative action levels and monitoring programs.

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

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

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

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

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

10 CFR 20.1801, “Security of stored material,” states that licensees shall secure from 

unauthorized removal or access licensed materials that are stored in controlled or unrestricted 

areas.

10 CFR 20.1802, “Control of material not in storage,” states that licensees shall control and 

maintain constant surveillance of licensed material that is in a controlled or unrestricted area 

and that is not in storage.

Refer to Appendix R 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. The majority of materials licensing actions will meet the criteria in 

10 CFR 51.22(c)(14)(xvi) for a categorical exclusion. This means that the licensing action will 

not require an environmental assessment or environmental impact statement in accordance with 

10 CFR 51.22(b), since the NRC has already determined that this type of licensing action does 

not have a significant impact on the environment. It is the applicant’s responsibility to review the 

guidance in Appendix R to determine whether the categorical exclusion applies to the licensing 

action.

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.
22

8.1 Item 1: License Action Type

Item 1 of NRC Form 313 states the following:

This is an application for (check appropriate item):

Type of Action License No.

[ ] A. New License Not Applicable

[ ] B. Amendment XX-XXXXX-XX

[ ] C. Renewal XX-XXXXX-XX

Check Box A for a new license request. Note that a pre-licensing visit may be required prior to 

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

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

issuance of the license.

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

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

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

8.2 Item 2: Applicant’s Name and Mailing Address

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 mailing address; these changes do not require a fee.

Note: the NRC must be notified before control of the license is transferred (see Section 9.1, 

“Timely Notification of Transfer of Control”) or when bankruptcy proceedings have been initiated

(see Section 8.2.1, “Notifications of Bankruptcy Proceedings”). 

8.2.1 Notification of Bankruptcy Proceedings

Regulations: 10 CFR 30.34(h)

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

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.
23

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

responsible for all regulatory requirements. The NRC must be notified when licensees are in 

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

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

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

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

bankruptcy actions are completed and may request that the United States 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, “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 Where Licensed Material Will Be Used or Possessed

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

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

facility at which licensed material will be used or stored (e.g., include locations for field studies 

or other off-site locations; list activities to be conducted at each location). The descriptive 

address should be sufficient to allow an NRC inspector to find the facility location. A post office 

box address is not acceptable. In addition, applicants are encouraged to provide global 

positioning system coordinates, as appropriate.

Applicants should identify the location of all facilities designed or established for special uses 

(e.g., panoramic irradiators, interim or long-term waste storage facilities, high activity 

laboratories, iodination facilities, alpha laboratories, incinerators, and animal facilities).

If byproduct material (e.g., portable gauging devices) will be used at temporary job sites, so 

indicate, and describe the scope of these activities.

If byproduct material is to be used in field studies, the activities must be specifically identified 

and authorized on the license. Section 8.6, “Purposes for which Licensed Material Will Be 

Used,” contains information required of applicants before granting authorization for field use of 

licensed material.

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

address or location not included with the application or 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).
24

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

greater than or equal to Category 2 quantities, as defined in 10 CFR 37.5, “Definitions,” 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 later in Section 8.5.2, “Financial Assurance and Recordkeeping for 

Decommissioning,” licensees must maintain permanent records describing 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). For fixed gauge licensees, acceptable records are leak test records, sketches, 

and written descriptions of specific locations where each gauge was used or stored and any 

information relevant to damaged devices or leaking radioactive sources.

8.4 Item 4: Person to Be Contacted about this Application

Identify the individual who can answer questions about the content of 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 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 only 

provides 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 (Appendix B), Items 5 through 11 should be submitted on 

separate sheets of paper. Applicants may use Appendix C for this purpose and should note 

that using the suggested wording of responses and committing to using the model procedures 

in this report will facilitate the NRC’s review.

8.5 Item 5: Radioactive Material

8.5.1 Unsealed or Sealed Byproduct Material

Regulations: 10 CFR 30.14, 10 CFR 30.15, 10 CFR 30.18, 10 CFR 30.19, 10 CFR 30.21, 

10 CFR 30.32(g), 10 CFR 30.32(i), 10 CFR 30.33, 10 CFR 31.5, 10 CFR 31.8, 10 CFR 31.11, 

10 CFR 32.210

Criteria: An application for a license will be approved if the requirements of 10 CFR 30.33, 

“General requirements for issuance of specific licenses,” are met. In addition, licensees will be 

authorized to possess and use only those sealed sources and devices that are specifically 

approved or registered by the NRC or an Agreement State.

Discussion: Each authorized radionuclide is listed on the NRC license by its element name, 

chemical and/or physical form, and the maximum possession limit.
25

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

(e.g., carbon-14(C-14)) in Item 5. It is necessary to specify whether the material will be 

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

that contains the radionuclide is not required. For volatile radioactive material, however, it is 

necessary to specify if the requested radionuclides will be acquired in free (volatile) or bound 

(non-volatile) form, because additional safety precautions are required when handling and using 

free form volatile material. For example, when requesting authorization to use tritium (H-3) or 

iodine-125 (I-125), the applicant must specify whether the material will be acquired in free form 

or bound form. If a radionuclide will be acquired in both free and bound forms, then separate 

possession limits for each form must be specified.

Applicants requesting an authorization to use volatile radioactive material must provide 

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

material.

If you plan to possess radioactive materials in excess of the quantities listed in 10 CFR 30.72, 

“Schedule C–Quantities of radioactive materials requiring consideration of the need for an 

emergency plan for responding to a release,” then you must provide with the application either 

(1) an evaluation showing that the maximum offsite dose because of a release of radioactive 

materials would not exceed 1 rem (0.01 Sievert (Sv)) effective dose equivalent or 5 rem 

(0.05 Sv) to the thyroid, or (2) an emergency response plan for responding to the release in 

accordance with the criteria listed in 10 CFR 30.32(i)(3). Refer to Regulatory Guide 3.67, 

“Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities,” 

Revision 1, issued April 2011, for additional information on emergency plans.

The anticipated possession limit in millicuries (mCi) or curie (Ci) for each radionuclide should

also be specified. Possession limits must cover the total anticipated inventory, including 

licensed material in storage and waste, and should be commensurate with the applicant’s needs 

and facilities for safe handling. Applicants should review the requirements for submitting a 

certification for financial assurance for decommissioning before specifying possession limits of 

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

the section on “Financial Assurance and Decommissioning.” 

A separate listing should be submitted for sealed sources and/or devices containing sealed 

sources, such as self-contained irradiators, or calibration and check sources. Applicants must 

provide the manufacturer’s name and model number for each requested sealed source and/or 

device so that the NRC can verify that they have been evaluated in a Sealed Source and Device 

(SSD) registration certificate. The SSD registration certificate documents the safety evaluation 

of sealed sources and devices that the NRC or an Agreement State performs before authorizing 

a manufacturer (or distributor) to distribute them to specific licensees. Accordingly, applicants 

should obtain a copy of the certificate and review it with the manufacturer or distributor, or with 

the NRC or the issuing Agreement State, to ensure that they use sources and devices 

according to the registration certificates. Licensees may not make any changes to the sealed 

source and/or device that would alter the description or specifications from those indicated in 

the registration certificate, without obtaining permission from the NRC in a license amendment.
26

Applicants should determine if the type, form, and amounts of any of the materials requested 

exceed those for Category 1 and Category 2 sources, which must be tracked in the National 

Source Tracking System (NSTS) in accordance with 10 CFR 20.2207, “Reports of transactions 

involving nationally tracked sources.” Such sources also may have additional requirements for 

security of these materials under 10 CFR Part 37, “Physical Protection of Category 1 and 

Category 2 Quantities of Radioactive Material.” 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”). Generally, 

ARDL licensees possess small quantities of material below the Category 2 quantities described 

in the IAEA’s “Code of Conduct on the Safety and Security of Radioactive Sources.” Refer to 

Appendix E, “Nationally Tracked Source Thresholds,” to 10 CFR Part 20, “Standards for 

Protection against Radiation,” for a list of radionuclides of interest and Category 2 quantities. If 

ARDL licensees acquire a Category 2 (or larger) quantity, applicants and licensees should refer 

to Item 8.10.9, “Security Program for Category 1 and Category 2 Materials ,” for more 

information.

Although this document does not explicitly cover source material and special nuclear material, 

applicants and licensees may request to list small amounts of source or special nuclear 

materials on the ARDL license when use of these materials is directly related to the use of 

byproduct material under the limited scope license (e.g., laboratory-scale research and 

development, or the use of depleted uranium as shielding). Applicants should submit separate 

applications for the use of source and special nuclear materials for purposes not directly related 

to the use of byproduct material under the limited scope license (e.g., sub-critical assemblies 

using plutonium-beryllium sources and testing of depleted uranium munitions). Applicants also 

should refer to NUREG-1556, Volume 17, “Program-Specific Guidance about Special Nuclear 

Material of Less Than Critical Mass Licenses.”

Requests to license naturally occurring radioactive material should be made to the appropriate 

regulatory agency. The NRC does not regulate most naturally occurring radioactive material. 

The NRC will license NORM if it is a discrete source that poses a threat similar to that of a 

discrete source of radium-226, and only in consultation with other federal agencies as listed in 

10 CFR 30.4 and is extracted or converted after extraction for use in commercial, medical, or 

research activity.

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

authorized on a license under one of the following conditions:

- They submit all the information identified in 10 CFR 32.210 that is usually 

provided by the manufacturer when the source or device is registered. 

- The item is an older source or device, and the applicant submits as much of the 

10 CFR 32.210 information as known, and all the additional information listed in 

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

- The source is a small calibration or reference source containing less than 1 

millicurie of a beta/gamma emitter or 10 microcuries of an alpha emitter that is

not required to be registered pursuant to 10 CFR 30.32(g)(3) and 32.210(g)(1).

- The applicant meets one of the criteria listed in 10 CFR 32.210(g)(2)
27

Before proceeding further, applicants should determine if their proposed uses of licensed 

material meet the criteria for exemptions listed in 10 CFR 30.14, “Exempt concentrations,” or 

10 CFR 30.18, “Exempt quantities.” If so, it is not necessary to submit an application to the

NRC for byproduct materials that are covered by the exemptions, provided that they are 

received from entities that are licensed to distribute them. 

Similarly, applicants should determine if their proposed uses of licensed material meet the 

requirements for a general license listed in 10 CFR Part 31. Such “generally licensed” materials

may be acquired, possessed, used, or transferred without obtaining a specific license from the

NRC. Examples are:

• Certain prepackaged units (typically called kits) containing byproduct material for 

conducting in vitro clinical or laboratory tests may be possessed and used under a 

general license as provided by 10 CFR 31.11, “General license for use of byproduct 

material for certain in vitro clinical or laboratory Testing.” Persons eligible for this 

general license are limited to physicians, veterinarians in the practice of veterinary 

medicine, clinical laboratories, and hospitals; however, these persons are required to 

register with the NRC before acquiring or using these units, unless they have an NRC 

license under 10 CFR Part 35.

• Certain devices containing sealed sources of byproduct material, such as electron 

capture detectors (ECDs) in gas chromatographs (GCs) and EXIT signs containing 

tritium, are authorized by the NRC or Agreement States for distribution to persons who 

are generally licensed (as well as to persons who are specifically licensed). Regulatory 

requirements for such devices possessed under a general license are provided in 

10 CFR 31.5, “Certain detecting, measuring, gauging, or controlling devices and certain 

devices for producing light or an ionized atmosphere.” Distributors of such devices must 

provide users with appropriate information related to the acquisition, use, and transfer of 

these generally licensed devices. The generally licensed devices also have labeling 

requirements that are different from those that are possessed under a specific license.

Response from Applicant:

• For unsealed materials:

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

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

– For potentially volatile materials (e.g., I-125, I-131, H-3, Kr-85), specify whether the 

material will be free (volatile) or bound (non-volatile) and the requested possession 

limit for each form.

• For sealed materials:

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

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

sources or total activity for each radionuclide.

− Provide the manufacturer’s (distributor’s) name and model number for each sealed 

source and device requested.
28

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

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

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.

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

is not registered, provide the applicable information as described in 10 

CFR 30.32 and 32.210.

• Provide an emergency plan if required by 10 CFR 30.32(i) and 30.72

References: 

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

Cycle and Materials Facilities,” Revision 1, April 2011.

• NUREG-1140, “A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and 

Other Radioactive Material Licensees, Final Report,” January 1988. See Notice of 

Availability on the inside front cover of this report to obtain copies of these documents. 

They are also available on the NRC’s Web site at www.nrc.gov.

8.5.2 Financial Assurance and Recordkeeping for Decommissioning

Regulations: 10 CFR 30.32(h), 10 CFR 30.34(b), 10 CFR 30.35, 10CFR 

30.34(b). CFR 30.36(e), 10 CFR 30.36(g)(4)(v), 10 CFR 30.36(k)(4), 10 CFR 30.51(d), 

10 CFR 30.51(e), 10 CFR 30.51(f), 10 CFR 40.31(i), 10 CFR 40.36, 10 CFR 40.42(e), 

10 CFR 40.42(g)(4)(v), 10 CFR 40.61(d), 10 CFR 40.61(e), 10 CFR 40.61(f), 

10 CFR 70.22(a)(9), 10 CFR 70.25, 10 CFR 70.38(e), 10 CFR 70.38(g)(4)(v), 10 CFR 70.51(b)

Criteria: A licensee authorized to possess licensed material 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. Pursuant to 10 CFR 30.35(g), licensees 

must transfer records important to decommissioning to new licensees before licensed activities 

are transferred in according to 10 CFR 30.34(b). Furthermore, pursuant to 10 CFR 30.51(f),

prior to license termination, each licensee shall forward the records required by 10 CFR 

30.35(g) to the appropriate NRC regional office.

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

effect on the public, occupational health and safety, and the environment. There are two parts 

to this rule: financial assurance that applies to some licensees, and record keeping that applies 

to all licensees.

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

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

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

facilities is possible at the conclusion or termination of licensed activities. 
29

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

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

available. Applicants are required to submit a certification of FA or a DFP, or both, when the 

possession of radioactive material with a half-life (T1/2) greater than 120 days exceeds certain 

limits. Criteria for determining if an applicant is required to submit a DFP and a certification of

FA (or neither) are stated in 10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25all entitled, 

“Financial assurance and record keeping for decommissioning.” A DFP contains a site-specific 

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

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

A DFP also will be required to be submitted by ANY licensee that identifies residual 

contamination levels that, if uncorrected, would exceed the criteria for release for unrestricted 

use (that which is distinguishable from background and would result in a dose that would 

exceed25 millirem in one year to a member of the critical group). If a licensee identifies such 

residual contamination during the required surveys of its facilities, a DFP must be submitted 

within one year of the survey.

Acceptable FA includes trusts; surety, insurance, or other guarantee methods (letters of credit, 

surety bonds, parent company guarantees, insurance policies), and statements of intent for 

Government entities. Criteria for parent company guarantees and self-guarantees can be found 

in Appendices A, C, D, and E to 10 CFR Part 30.

Table 8.1 is a partial list of radionuclides of T1/2 > 120 days with their corresponding limits in 

excess of which a certification of FA or a DFP, or both, is required. However, it is the NRC’s 

experience that most ARDL licensees use only a few of these radionuclides, and that the most 

frequently used radionuclides on this list are hydrogen-3 (H-3 or tritium) and carbon-14 (C-14) in 

unsealed form. The amount of such radionuclides ARDL licensees requires rarely exceeds the 

limits that require submitting a DFP or a certification of FA. See Table 8.2 for possession limits 

and guidance for submitting either a DFP or a certification of FA. Radionuclides of T1/2 > 120 

days are listed in column 1. Column 2 lists the corresponding possession limits of radionuclides 

in unsealed form requiring a certification of FA. These limits apply when only one of these 

radionuclides is possessed. If more than one radionuclide is possessed, the sum-of-fractions 

must be calculated to determine if a FA is required.
30

Figure 8.1 Methods of Certification of Financial Assurance for Decommissioning

Applicants can use Table 8.2 and the guidance in NUREG-1757, Volume 3, “Consolidated 

Decommissioning Guidance—Financial Assurance, Recordkeeping, and Timeliness,” to 

determine if FA is required and the amount required. When one or more of these radionuclides 

is requested, a sum-of-fractions calculation must be performed (unity rule). If the sum exceeds 

1, then FA is required. Most ARDL licensees use a small number of these radionuclides, and in 

many cases, such licensees may be able to adjust the amounts of these radionuclides so that 

the FA requirement is not applicable. If other long-lived radionuclides are used, the applicant 

should refer to 10 CFR 30.35 and Appendix B to Part 30 for the applicable quantities.

Table 8.1 Commonly Used Unsealed Licensed Materials Requiring Financial Assurance

and Decommissioning Funding Plan

Column 1: Radionuclide Column 2: Limit for FA (millicuries*)

calcium-45 10

carbon-14 100

chlorine-36 10

hydrogen-3 1,000

zinc-65 10

*1 millicurie = 37 MBq

NUREG-1757, Volume 3, provides guidance acceptable to the NRC staff on the information to 

be provided for establishing FA for decommissioning and a standard format for presenting the 

information. Note that FA is required for four types of licensed materials: unsealed byproduct 

material (10 CFR 30.35); sealed byproduct material (10 CFR 30.35); dispersible source material

(10 CFR 40.36); and unsealed special nuclear material (10 CFR 70.25). The total amount of FA

required is the sum of the FA required for each of these types of materials.

Recordkeeping

The requirements for maintaining records important to decommissioning, including the type of 

information required, are stated in 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g). 

Such records include decommissioning records related to structures and equipment in which 

licensed materials are used and stored, as well as records related to spills, leaking sources, or 

other events that may result in residual contamination. 
31

All licensees are required to maintain these records in an identified location until the site 

is released for unrestricted use (see Figure 8.2). In the event that the licensed activities are 

transferred to another NRC or Agreement State licensee, these records shall be transferred to 

the new licensee before transfer of the licensed activities in accordance with 10 CFR 30.35(g). 

The new licensee is responsible for maintaining these records until the license is terminated. 

When the license is terminated, these records shall be transferred to the NRC.

Figure 8.2 Types of Records that Must Be Maintained for Decommissioning

10 CFR 30.35(g), Requirements for Disposition of Records Important to 

Decommissioning

• Before licensed activities are transferred or assigned according to 10 CFR 30.34(b), 

transfer to the new licensee

OR

• Before the license is terminated, transfer records to the appropriate NRC regional 

office.
32

Response from Applicants: 

• State the following: “Pursuant to 10 CFR 30.35(g), we shall transfer records important to 

decommissioning to the new licensee 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 shall forward the records required by 10 CFR 

30.35(g) to the appropriate NRC regional office. ”

AND

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

guidance of NUREG-1757, Volume 3.

8.6 Item 6: Purposes for which Licensed Material Will Be Used

Regulations: 10 CFR 30.4, 10 CFR 30.33(a)(1), 10 CFR 51.21, 10 CFR 51.22

Criteria: The applicant must specify the purpose of use for each sealed and unsealed 

radionuclide requested. All sealed sources and devices containing licensed material shall be 

used only for the purpose for which they are designed, and according to manufacturer’s 

(distributor’s) instructions and recommendations for use as specified in the SSD registration 

certificate.

Discussion: Applicants should clearly specify the purpose for which each radionuclide will be 

used. The description should be detailed enough to allow the NRC to determine the potential 

for exposure to radiation and radioactive materials, to those working with radioactive materials 

and members of the public.

Research and development, as defined in 10 CFR 30.4, “Definitions,” does not include research 

involving the use of licensed material in or on humans. Applicants planning to use licensed 

materials for medical research involving humans must be authorized to do so pursuant to a 

license issued under 10 CFR Part 35, and should refer to NUREG-1556, Volume 9, 

“Consolidated Guidance about Material Licenses: Program Specific Guidance about Medical 

Use Licenses.”

Applicants may use the format given in Table 8.2 to provide the requested information.

Table 8.2 Sample Format for Providing Information about Requested Radionuclides

Radionuclide Chemical and Physical 

Form

Maximum Possession 

Limit

Proposed Use

H-3 Unbound and volatile 100 millicuries Labeling of compounds

H-3 Bound and nonvolatile 100 millicuries In vitro studies; studies 

in small lab animals

P-32 Any 30 millicuries In vitro studies; labeling 

of compounds
33

Radionuclide Chemical and Physical 

Form

Maximum Possession 

Limit

Proposed Use

I-125 Unbound and volatile 30 millicuries Protein iodination

I-125 Bound and nonvolatile 50 millicuries In vitro studies; studies 

in small lab animals; 

calibration of instruments

Cs-137 Sealed source, Mfg. 

name/model number

20 millicuries per source 

and 40 millicuries total

Calibration of 

instruments

Use of licensed materials in animals: Applicants should clearly specify if the licensed 

material will be used in animals for research studies, or by veterinarians for diagnostic and 

therapeutic purposes. Applicants should also state whether the studies will be limited to small 

animals (e.g., rats, mice) or may also include larger animals (e.g., dogs, pigs, horses). 

Similarly, the veterinary use should specify whether the material will be used in pets (cats, dogs) 

or in farm animals (cattle, horses, pigs). Appendix E provides guidance for developing radiation 

safety procedures for these studies and describes additional information to be submitted with 

the application.

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

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

studies that may result in the release of licensed material into the environment, an 

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

Identification of Licensing and Regulatory Actions Requiring Environmental Assessments.”

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

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

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

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

Accession No. ML092321078), provide further guidance. Both these memoranda are publicly 

available and can be accessed through the NRC’s Agencywide Documents Access and 

Management System (ADAMS), which is accessible from the NRC Web site at 

http://www.nrc.gov/reading-rm/adams.html. Applicants for tracer or field studies must provide 

the NRC with a description of the study for review and approval before performing such studies.

If you want to perform field studies in which licensed material is deliberately released to the 

environment for the purposes of studies, please provide the following information:

(1) A complete application describing the type and amount of material to be used, the 

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

(2) A complete experimental protocol.

(3) A description of the amount of radioactive material to be released in the field, 

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

procedures for minimizing releases.

(4) A description of the expected radiation dose to humans.
34

(5) Written permission from the property owner to use radioactive materials at the proposed 

site.

(6) A letter from the appropriate State health authorities indicating that they have reviewed 

your application and concur with your request.

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

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

Federal, State, or local regulatory requirements.

Response from Applicant: List the specific use or purpose of each radionuclide.

Reference: Supplement to Policy and Guidance Directive FC 84-20, “Impact of Revision of 

10 CFR Part 51 on Materials License Actions,” dated March 1994, ADAMS Accession 

No. ML032590987.

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

Training and Experience

8.7.1 Radiation Safety Officer 

Regulations: 10 CFR 30.33(a)(3), 30.34(e)

Criteria: RSOs must have training and specific experience, with the types and quantities of 

licensed material to be authorized on the license.

Discussion: The person responsible for implementing the radiation protection program is the 

radiation safety officer, or RSO. The RSO needs independent authority to stop operations that 

he or she considers unsafe. He or she must have sufficient time and commitment from 

management to fulfill certain duties and responsibilities to ensure that radioactive materials are 

used in a safe manner. Typical RSO duties are illustrated in Figure 8.3 and described in 

Appendix F. The NRC lists the name of the RSO on the license to ensure that licensee 

management has identified a responsible, qualified person and that the named individual knows 

of his or her designation as RSO.
35

Figure 8.3 Typical Duties and Responsibilities of RSOs

The NRC believes that to demonstrate adequate training and experience, the RSO should have 

(1) at a minimum, a college degree at the bachelor’s level, or equivalent training and experience 

in physical, chemical, biological sciences, or engineering; and (2) training and experience 

commensurate with the scope of proposed activities. 

Training should include the following subjects:

• radiation protection principles 

• characteristics of ionizing radiation

• units of radiation dose and quantities

• radiation detection instrumentation

• biological hazards of exposure to radiation (appropriate to types and forms of byproduct 

material to be used)

• NRC regulatory requirements and standards

• hands-on use of radioactive materials

Experience should include the following areas:
36

• planning and conducting evaluations, surveys, and measurements similar to those that 

the licensee’s radiation safety program requires

• use of licensed materials similar in types, forms, and quantities to those proposed for 

use under the license

• security and control of licensed materials

• monitoring inventory of materials possessed under the license; maintaining records of 

receipts, transfers, and disposal of licensed materials

• storage, handling, disposal, and documentation of radioactive waste materials

• planning, conducting and documenting audits and other evaluations of the radiation

safety program

• evaluation and documentation of radiation exposures

• maintaining required records of the radiation safety program and providing required 

reports

• other applicable duties and responsibilities as described in Appendix F

The amount of training and experience will depend on the type, form, quantity, and proposed 

use of the licensed material requested. For instance, in addition to a college degree, RSOs at 

larger licenses where workers handle significant quantities of radioactive material may need 

additional training in the field of radiation protection and may need 40 hours of radiation safety 

training specific to their job duties. An individual also may need a year of experience with 

similar types, forms, quantities, and uses of radioactive material before the individual is qualified 

to be an RSO. On the other hand, RSOs at licenses using microcurie and small millicurie 

quantities may only require a few hours of radiation safety training to be qualified as an RSO. 

The proposed RSO’s training and experience must be sufficient to identify and control the 

anticipated radiation hazards. In addition, the RSO designee should have obtained the above 

training in a formal course designed for RSOs, presented by an academic institution, 

commercial radiation safety consulting company, or a professional organization of radiation 

protection experts.

Response from Applicant: Provide the following:

• Name of the proposed RSO

• Information demonstrating that the proposed RSO is qualified by training and 

experience. Information should include, as a minimum:

− Formal training or education in radiation safety (topics covered, duration of training,

when training was received, identity and location of training provider (note: a course 

outline may be provided) 
37

− Experience using licensed materials (types, forms, quantities handled, activities 

performed, duration of experience)

− Experience performing the duties of an RSO (activities, duration of experience, scope 

of program)

Applicants should provide information about the proposed RSO’s training and experience that 

is relevant to the licensed material requested in the application. Applicants should not submit 

extraneous information, such as unrelated lists of publications, research grants, committee and 

society memberships. Submittal of unrelated material only serves to slow the review process. 

In addition, the information submitted should not contain PII (see Chapter 6, ““Identifying and 

Protecting Sensitive Information”).

Note: It is important to notify the NRC, as soon as possible, of changes in the designation of 

the RSO. The name and qualifications of the replacement RSO must be submitted to the NRC

as part of an amendment request.

8.7.2 Authorized User

Regulations: 10 CFR 20.1101(b), 10 CFR 30.33(a)(3)

Criteria: Authorized users (AUs) must have adequate training and experience with the types 

and quantities of licensed material they propose to use.

Discussion: An AU (also known as “principal investigator,” “permit holder,” “source custodian,” 

or by other licensee designations) is a person whose training and experience have been 

reviewed and approved by the NRC, who is named on the license, and who uses or directly 

supervises the use of licensed material. The AU’s primary responsibility is to ensure that 

radioactive materials used in his or her particular lab or area are used safely and according to 

regulatory requirements (see Figure 8.4). The AU is also responsible for ensuring that 

procedures and engineering controls are used to keep occupational doses and doses to 

members of the public ALARA.
38

Figure 8.4 Authorized User

The AU is responsible for the safe use of licensed material in his or her laboratory or area.

AUs must have adequate and appropriate training to provide reasonable assurance that they 

will use licensed material safely, including maintaining security of, and access to, licensed 

material, and respond appropriately to events or accidents involving licensed material to prevent 

the spread of contamination.

The NRC believes that to demonstrate adequate training and experience, the AU should have 

(1) a college degree at the bachelor’s level, or equivalent training and experience in physical, 

chemical, biological sciences, or engineering; and (2) training and experience commensurate 

with the scope of proposed activities. Training should include the following subjects:

• radiation protection principles

• characteristics of ionizing radiation

• units of radiation dose and quantities

• radiation detection instrumentation

• biological hazards of exposure to radiation (appropriate to the types and forms of 

byproduct material to be used)

• hands-on use of radioactive materials
39

The amount of training and experience needed will depend upon the type, form, quantity, and 

proposed use of the licensed material requested, but it should cover the subjects stated.

An AU is supervising the use of radioactive materials when he or she directs personnel in 

operations involving the licensed material. Although the AU may delegate specific tasks to 

supervised users (e.g., conducting surveys, keeping records), he or she is responsible for the 

safe use of radioactive material to ensure that areas are not contaminated.

Applicants must name at least one individual who is qualified to use the requested licensed 

materials. In general, AUs must demonstrate training and experience with the type and quantity 

of material they propose to use. For example, someone with training and experience only with 

sealed radioactive sources may not be qualified to use or supervise the use of unsealed 

licensed material. In addition, someone with experience using only trace quantities may not 

understand the risks of working with much larger (e.g., 10 or 100 times larger) quantities of the 

same substance. Applicants should pay particular attention to the type of radiation involved. 

For example, someone experienced with gamma emitters may not have appropriate experience 

for high energy beta emitters.

Response from Applicant:

Applicants should provide the following:

• Name of each proposed AU with the types and quantities of licensed material to be used

• Information demonstrating that each proposed AU is qualified by training and experience 

to use the requested licensed materials. Information should include, as a minimum:

− Formal training or education in radiation safety (topics covered; duration of training;

when training was received; identity and location of training provider (note: a course 

outline may be provided) 

− Experience using licensed materials (types; forms; quantities handled; activities 

performed; duration of experience)

Applicants should provide information about the proposed AU’s training and experience relative 

to the licensed material requested in the application. Applicants should not submit extraneous 

information, such as unrelated lists of publications, research grants, committee and society 

memberships, etc. Submittal of unrelated material serves only to slow the review process.

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

(Occupationally Exposed Individuals and Ancillary Personnel)

Regulations: 10 CFR 19.11, 10 CFR 19.12, 10 CFR 19.13, 10 CFR 30.7, 10 CFR 30.9, 

10 CFR 30.10, 10 CFR 30.33(a)(3) 

Criteria: Individuals whose assigned duties involve exposure to radiation or radioactive 

material (from both licensed and unlicensed sources), and in the course of their employment are 

likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem), 
40

must receive instruction commensurate with their duties and responsibilities, as required by 

10 CFR 19.12, “Instructions to Workers.”

Discussion: Before beginning work with licensed material, most individuals must receive 

radiation safety training commensurate with their assigned duties and specific to the licensee’s 

radiation safety program. Each individual should also receive periodic (for example, annual)

refresher training.

Licensees should not assume that safety instruction has been adequately covered by prior 

employment or academic training. Site-specific training should be provided for all individuals. 

Particular attention should be given to persons performing work with radioactive materials that 

may require special procedures, such as hot cell work, waste processing, and animal handling. 

Also, ancillary personnel (e.g., clerical, housekeeping, security) whose duties may require them 

to work in the vicinity of radioactive material (whether escorted or not) need to be informed 

about radiation hazards and the appropriate precautions. The licensee should assess each 

individual’s involvement with licensed material and cover each applicable subject appropriately.

Training may be in the form of lecture, demonstrations, videotape, or self-study, and should 

emphasize practical subjects important to the safe use of licensed material. The guidance in 

Appendix G may be used to develop a training program. The program should consider both the 

topics pertinent for each group of workers and the method and frequency of training.

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

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

Response from Applicant: Submit a description of the radiation safety training program, 

including topics covered, groups of workers, assessment of training, qualifications of instructors, 

and the method and frequency of training.

8.9 Item 9: Facilities and Equipment

Regulations: 10 CFR 20.1101(b), 10 CFR 20.1406, 10 CFR 30.33(a)(2), 10 CFR 30.35(g)

Criteria: Facilities and equipment must be adequate to protect health and minimize danger to 

life or property. They must minimize the possibility of contamination and keep exposures to 

workers and the public ALARA. Applicants must describe how facility design and procedures 

for operation will minimize, to the extent practicable, contamination of the facility and the 

environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the 

generation of radioactive waste.

Discussion: Applicants must demonstrate that their facilities and equipment provide sufficient 

engineering controls and barriers to protect the health and safety of the public and their 

employees, keep exposures to radiation and radioactive materials ALARA, and minimize the 

danger to life and property from the uses of the types and quantities of radioactive materials that 

will be used.

Applicants may delay completing facilities and acquiring equipment until after the application 

review is completed, in case changes are required as a result of the application review. 
41

This also ensures the adequacy of the facilities and equipment before the applicant makes a 

significant financial commitment. In all cases, the applicant may not possess or use licensed 

material until after the facilities are approved, equipment is procured, and the license is issued.

Applicants are reminded that records important to decommissioning as described in 10 CFR 

30.35(g) must include the following:

• as-built drawings and modifications of structures and equipment in restricted areas

• as-built drawings and modifications of locations of possible inaccessible contamination 

such as buried pipes that may be subject to contamination

• records of spills and unusual occurrences that may result in contamination of the facility 

or site

These records are required to be maintained in an identifiable location. Facilities are required to 

meet the NRC criteria prior to release. Therefore, careful facility design is important to prevent 

contamination, or facilitate decontamination, reducing the costs needed for decommissioning. 

For further information, see the section entitled, “Financial Assurance and Record Keeping for 

Decommissioning.”

Appendix H provides additional guidance on facilities and equipment.

If radioactive materials will be used with animals, include a description of the animal handling 

housing facilities. (See Appendix E)

When designing facilities and developing procedures for their safe use, applicants should think 

ahead and consider how to minimize radioactive contamination during operation, 

decontamination and decommissioning efforts, and radioactive waste generation. When 

submitting new applications, applicants should consider the following:

• implementation of and adherence to good health physics practices in operations

• minimization of areas, to the extent practicable, where licensed materials are used and 

stored

• maximization of the frequency of surveys, within reason, to minimize spread of 

contamination in the event of a spill

• choice of isotope to be used, whenever practical, in consideration of half-life and 

chemical composition

• appropriate filtration of effluent streams

• use of nonporous materials for such areas as laboratory bench tops and flooring

• ventilation stacks and ductwork with minimal lengths and minimal abrupt changes in 

direction
42

• use of appropriate plumbing materials with minimal pipe lengths and traps

• minimization of the number of disposal sites (sinks) where liquid waste is disposed

Response from Applicant: 

• Describe the facilities and equipment that will be available at each location where 

radioactive material will be used (see Appendix H for topics to consider). 

• Include a description of the area(s) assigned for the receipt, storage security, 

preparation, measurement, use and disposal of radioactive materials

• Submit a diagram showing the locations of shielding, the proximity of radiation sources 

to unrestricted areas, and other items related to radiation safety. 

− When applicable to facilities where radioactive materials may become airborne, the 

diagrams should contain schematic descriptions of the ventilation systems, with 

pertinent airflow rates, pressures, filtration equipment, and monitoring systems. 

− Diagrams should be drawn to a specified scale, or dimensions should be indicated.

− For facilities where it is anticipated that more than one laboratory or room may be 

used, a generic laboratory or room diagram may be submitted.

• Describe how facility design and procedures for operation will minimize contamination of 

the facility and the environment, facilitate eventual decommissioning, and minimize the 

generation of radioactive waste.

8.10 Item 10: Radiation Safety Program

8.10.1 Audit Program 

Regulations: 10 CFR 20.1101, 10 CFR20.2101 through 20.2110, 10 CFR 21.21(a)

Criteria: Licensees must review the content and implementation of their radiation protection 

programs at least annually to ensure that the program:

• is commensurate with the scope and extent of licensed activities

• complies with NRC and DOT regulations (as applicable), and the terms and conditions of 

the license

• ensures that occupational doses and doses to members of the public are ALARA 

(10 CFR 20.1101)

• is documented, and appropriate records are maintained for the duration required by the 

regulations
43

Discussion: Appendix I contains a suggested audit program that is specific to ARDL licensees 

and is acceptable to the NRC. All areas indicated in Appendix I may not be applicable to every 

licensee and may not need to be addressed during each audit. For example, licensees do not 

need to address areas that do not apply to their activities or activities that have not occurred 

since the last audit. Generally, audits are conducted at least once every 12 months. During 

inspection, the NRC observes work in progress. As a part of their audit programs, applicants 

should consider performing unannounced observations of byproduct material users to 

determine, for example, if safe use and emergency procedures are available and being 

followed.

If an audit identifies violations of NRC requirements, the licensee should first evaluate the safety 

significance of each violation to set priorities and identify resources to correct these violations. 

Information Notice (IN) 96-28, “Suggested Guidance Relating to Development and 

Implementation of Corrective Action,” dated May 1, 1996, provides guidance on this subject. 

Certain identified problems or potential violations may require notification or a report to the 

NRC. Licensees are encouraged to contact the NRC for guidance if there is any uncertainty 

about a reporting requirement. The NRC routinely reviews licensee’s records to verify if 

appropriate corrective actions were implemented in a timely manner to address 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. For information on the NRC’s use of discretion in issuing a notice of violation, 

refer to the most recent version of NRC’s enforcement documents at 

http://www.nrc.gov/reading-rm/doc-collections/enforcement/. The NRC’s Enforcement Policy 

may be found online at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html

and the Enforcement Manual may be found online at http://www.nrc.gov/aboutnrc/regulatory/enforcement/guidance.html.

Licensees must maintain records of these audits and other reviews of program content and 

implementation for 3 years from the date of the record. Records of these audits should include 

the following information: date of audit, name of person(s) who conducted the audit, persons 

contacted by the auditor(s), areas audited, audit findings, corrective actions, and followup. 

These records must be maintained for NRC inspections.

Response from Applicant: The applicant is not required to, and should not, submit its audit 

program to the NRC for review during the licensing phase. However, this matter may be 

reviewed during NRC inspections.

References: 

• Inspection Procedure 87126, “Industrial/Academic/Research Programs,” 

September 2005.

• Information Notice 96-28, “Suggested Guidance Relating to Development and 

Implementation of Corrective Action,” May 1, 1996.

• Enforcement guidance and policy, available online at http://www.nrc.gov/reading-rm/doccollections/enforcement/.
44

8.10.2 Radiation Monitoring Instruments 

Regulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2)

Criteria: Licensees must possess, or have access to, radiation monitoring instruments that are 

necessary to protect health and minimize danger to life or property. Instruments used for 

quantitative radiation measurements must be calibrated periodically for the radiation measured.

Discussion: Licensees shall possess, or have access to, calibrated radiation detection and 

measurement instruments or licensed services to perform, as necessary the following:

• package surveys

• contamination surveys

• sealed source leak tests

• air sampling measurements

• bioassay measurements

• effluent release measurements

• unrestricted area dose rate measurements

For the purposes of this document, survey instruments are defined as any device used to 

measure the radiological conditions at a licensed facility. Some survey instruments that may be 

used to perform the above functions include:

• portable or stationary count rate meters

• portable or stationary dose rate or exposure rate meters

• single or multichannel analyzers

• liquid scintillation counters (LSC)

• gamma counters

• proportional counters

• solid state detectors

Other equipment and instrumentation associated with the radiation hazard assessment also 

must be calibrated periodically, in accordance with 10 CFR 20.1501(c). This includes 

equipment used to collect radiological samples to perform assessments of airborne hazards, 

and other radiological hazards that cannot be directly assessed. Such equipment includes

• rotometers

• anemometers

• other devices that measure flow rates, volumes, and time
45

Figure 8.5 Examples of Portable Instruments Used in Laboratory Settings
46

The choice of instrument should be appropriate for the type of radiation to be measured, and for 

the type of measurement to be taken (count rate, dose rate, etc.). Figure 8.5 illustrates some

common survey instruments used for contamination surveys. Applications should include 

descriptions of the instrumentation available for use and the instrumentation the applicants plan 

to purchase before starting licensed activities. The description should include type of instrument 

and probe, and the instrument’s intended purpose.

Instruments used for qualitative surveys are only intended to detect contamination in the 

laboratory. Such instruments should be checked for operational response with an appropriate 

check source containing radioactive material; they can be calibrated with an electronic pulser 

instead of a radioactive source. However, these instruments cannot be used for measuring

surface contamination or radiation levels without a calibration with appropriate radioactive 

sources, as described in Appendix J.

Calibration of an instrument should be performed before it is used for the first time, and at least 

annually thereafter. Calibration should also be performed after any repair to the instrument. 

The NRC requires that calibrations be performed by the instrument manufacturer, or a person 

specifically authorized by NRC or an Agreement State, unless the applicant specifically requests 

this authorization. Applicants seeking authorization to perform survey instrument calibrations 

shall submit procedures for review. Appendix J provides information about instrument 

specifications and model calibration procedures.

Response from Applicant: Provide one of the following:

A description of the instrumentation (as described above) that will be used to perform required 

surveys and a statement that: “We will use instruments that meet the radiation monitoring 

instrument specifications published in Appendix J in the NUREG-1556, Volume 7, Revision 1,

‘Program-Specific Guidance about Academic, Research and Development, and Other 

Laboratory Licenses of Limited Scope.’ We reserve the right to upgrade our survey instruments 

as necessary. Additionally, instruments will be calibrated before first use, at least annually 

thereafter, and after any repair, by a vendor who is licensed by the NRC or an Agreement State 

to perform instrument calibrations.”

OR

A description of the instrumentation (as described above) that will be used to perform required 

surveys and a statement that: “We will use instruments that meet the radiation monitoring 

instrument specifications published in Appendix J in NUREG-1556, Volume 7, Revision 1,

‘Program-Specific Guidance about Academic, Research and Development, and Other Licenses 

of Limited Scope.’ We reserve the right to upgrade our survey instruments as necessary. 

Additionally, we will implement the model survey meter calibration program published in 

Appendix J NUREG-1556, Volume 7, Revision 1, ‘Program-Specific Guidance about Academic, 

Research and Development, and Other Licenses of Limited Scope.’” 

OR
47

A description of alternative equipment or procedures for ensuring that appropriate radiation 

monitoring equipment will be used during licensed activities and that proper calibration at the 

required frequency of survey equipment will be performed. Further, the response should 

include the statement: “We reserve the right to upgrade our survey instruments as necessary.”

Note: Alternative responses will be reviewed using the criteria listed above.

8.10.3 Material Receipt and Accountability 

Regulations: 10 CFR 30.34(e), 10 CFR 30.35(g), 10 CFR 30.41, 10 CFR 30.51, 

10 CFR 20.1501(a), 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1906, 10 CFR 20.2001, 

10 CFR 20.2108, 10 CFR 20.2201, 10 CFR 20.2207, 10 CFR 31.11

Criteria: Licensees must do the following:

• Develop, implement, and maintain written procedures for safely opening packages.

• Develop, implement, and maintain procedures to ensure security and accountability of 

licensed material.

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

• Update transactions in the National Source Tracking System (NSTS), including an 

annual inventory reconciliation, if applicable.

Discussion: To ensure that only trained, experienced, and authorized individuals use or 

supervise the use of licensed material, the RSO should know who has requested an order of 

licensed material and the types and amounts of licensed materials requested. Control 

procedures also should be established for the procurement of licensed materials that may be 

obtained outside normal channels (e.g., through the loan or other transfer of materials without 

purchase or through surplus). Appendix K includes a model procedure for ordering and 

receiving radioactive material.

Licensed material becomes part of the licensee’s inventory at the time that it is received by the 

licensee, be it during normal working hours or after hours when delivered by the carrier in 

accordance with procedures established by the licensee. If through some error, the licensee 

receives material it is unauthorized to possess or receives quantities of material that would 

result in the total inventory being in excess of license possession limits, the licensee should 

place the package in secure storage and arrange for the return of these materials in a timely 

manner. If returning the materials is not possible, the licensee should contact the NRC 

Regional Office and request issuance of an expedited license amendment. The materials must 

not be used until the amendment is granted.

Licensees should arrange to receive radioactive packages when they are delivered, or to be 

notified when radioactive packages arrive at the carrier’s terminal so that the licensee can pick 

up the package expeditiously. Licensees are required to develop, implement, and maintain 

written procedures for safely opening packages in accordance with 10 CFR 20.1906, 

“Procedures for Receiving and Opening Packages.” 
48

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

or half-life of the nuclide being delivered. A model procedure for safely opening packages 

containing licensed materials is included in Appendix K.

In limited scope radiation safety programs, the RSO or his or her staff usually receives the 

incoming package directly from the carrier and performs all verification, surveying, opening, and 

documentation for inventory. The package is then delivered to the AU, or the AU retrieves the 

package from the RSO. If the package is transported over public roads by the licensee, it must 

be repackaged and transported in accordance with DOT regulations.

If the package of licensed material is delivered to the licensed facility’s receiving department 

(Receiving), individuals working in that department should be trained to do the following:

• Identify the package as radioactive by labeling and shipping papers.

• Segregate the package from other incoming items in a secured area until released by 

the RSO

• Notify the RSO.

When notified by receiving that a package of licensed material has arrived, the RSO or his/her 

staff should retrieve the package and follow the safe opening procedures. NRC regulations in 

10 CFR 20.1906(b) and (c) state the requirements for monitoring packages containing licensed 

material. These requirements are described in Table 8.3, below.

Table 8.3 Package Monitoring Requirements

Package Contents Survey Type Survey Time*

Damaged Licensed Material Radiation Level 

Contamination

As soon as practicable, 

but not later than 

3 hours after receipt of 

package

Labeled (White I, 

Yellow II, Yellow III)

Not Gas Nor Special Form

Greater Than Type A

Radiation Level 

Contamination

As soon as practicable, 

but not later than 

3 hours after receipt of 

package

Labeled (White I, 

Yellow II, Yellow III)

Gas or Special Form

Greater Than Type A

Radiation Level As soon as practicable, 

but not later than 

3 hours after receipt of 

package

Labeled (White I, 

Yellow II, Yellow III)

Not Gas Nor Special Form

Less Than Type A

Contamination As soon as practicable, 

but not later than 

3 hours after receipt of 

package

Labeled (White I, 

Yellow II, Yellow III)

Gas or Special Form

Less Than Type A

None None

Not Labeled Licensed Material None None
49

* Assumes packages are received during normal working hours. If packages are received 

outside of normal working hours, the licensee has 3 hours after the beginning of the next 

work day to perform the required surveys.

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

carrier and the NRC Operations Center (310-816-5100), by telephone, when removable 

radioactive surface contamination exceeds the limits specified in 10 CFR 71.87(i), or when 

external radiation levels exceed the limits of 10 CFR 71.47, “External radiation standards for all 

packages.” These limits that are applicable to most packages that ARDL licensees receive are: 

(1) radiation levels shall not exceed 200 mrem/hour, and (2) removable radioactive surface 

contamination for beta/gamma emitters and low toxicity alpha emitters shall not exceed, 

220 disintegration per minute per centimeter squared (dpm per cm2

); or for all other alpha 

emitters 22 dpm/cm2

).

As illustrated in Figure 8.6, licensed materials must be tracked from “receipt to disposal” in order 

to ensure accountability and to ensure that possession limits listed on the license are not 

exceeded.

Figure 8.6 Material Receipt and Accountability

Licensees must maintain records of receipt, transfer, and disposal of licensed material.

Regulations in 10 CFR 20.1801 and 10 CFR 20.1802 require licensees to secure radioactive 

materials from unauthorized removal or access while in storage in controlled or unrestricted 

areas and to control and maintain constant surveillance over licensed material that is in a 

controlled or unrestricted area and is not in storage. Applicants for limited scope licenses 

should establish policies and procedures to ensure compliance with security requirements. It is 

recognized that loss, theft, or misplacement of licensed material can occur; however, licensees 

should have an accountability and control system in place for promptly detecting losses of 

licensed material.

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

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

tracked source shall complete and submit a National Source Tracking System Transaction 
50

Report. The NSTS is a secure, accessible, and easy-to-use computer system that tracks highrisk radioactive sources from the time they are manufactured or imported through the time of 

their disposal or export, or until they decay below threshold levels. Additional information on 

this subject is provided in Section 8.10.9, “Security Program for Category 1 and Category 2 

Materials.”

Licensees Who Also Possess Radioactive Materials under a General License or an 

Exemption

In addition to radionuclides that are specifically listed on their license, licensees frequently 

possess radioactive material that is generally licensed or distributed to them as an exempt 

quantity or item. Regulations in 10 CFR Part 31 provide information on generally licensed 

devices. Any person who acquires, receives, possesses, uses, or transfers a generally licensed 

device must do so in accordance with the provisions of the general license. Generally, licensed 

material that a specific licensee possesses may continue to be possessed under a general 

license. A specific license does not automatically remove general licensee status nor 

automatically “move” generally licensed material to the specific license. The NRC recognizes 

that multiple authorizations can create some confusion; therefore, a specific licensee always 

has the option of receiving and possessing radioactive materials that “qualify” for a general 

license, by adding these to its specific license as described in 10 CFR 31.5(c)(8)(iii) or other 

applicable regulations. Persons who wish to convert generally licensed items to a specifically

licensed item should discuss the process with the regulator. 

Some facilities may have separate laboratories or locations that use material for in-vitro assay, 

which they may possess under the general license in 10 CFR 31.11. Each location may be 

considered to operate under a separate general license from the other. The locations are not 

considered part of the specific license. In accordance with 10 CFR 31.11(c)(1), the possession 

limit of 7.4 MBq (200 microcuries), only applies to a total amount of I-125, iodine-131 (I-131), 

selenium-75 (Se-75), or iron-59 (Fe-59) used or stored in one location.

Similarly, radioactive material received by specific licensees, that is distributed to them under an 

exemption from the requirements for a license, is not subject to the terms and conditions of the 

specific license. Any person may receive byproduct material that is exempt from the 

requirements of a license under 10 CFR 30.11, “Specific exemption,” through 10 CFR 30.21, 

“Radioactive drug: Capsules containing carbon-14 for ‘in vivo’ diagnostic use for humans.” 

Such materials may include “exempt quantities” of byproduct materials that do not exceed the 

applicable quantity listed in 10 CFR 30.71, “Schedule B,” as well as items such as smoke 

detectors and self-luminous watches, which are distributed in accordance with other NRC 

regulations. Most licensees do not possess or control these types of devices under the 

provisions of their specific license and the NRC does not require or encourage this practice; 

however, as stated above, the specific licensee always has the option to add these materials to 

its license, and control them under the conditions of the specific license. In any case, licensees 

are required to ensure that dose limits are not exceeded, whether the dose results from licensed 

sources or unlicensed sources.
51

Inventory and Accountability of Radioactive Materials

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

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

rarely used and are placed in storage. In these cases, licensees should confirm at least every 

6 months that these sealed sources have not been disturbed. Licensees also are required to 

conduct leak tests of sealed sources at 6-month intervals (or at longer intervals as specified in 

the SSD registration certificate). Since leak tests require an individual to locate and work with 

the sealed source, leak test records may be used as part of an inventory and accountability 

program.

ARDL licensees may use various methods (e.g., computer programs, manual ledgers, log 

books) to account for the inventory of unsealed materials from the time of receipt, through the 

use and storage of the unsealed materials, to removal from inventory through transfer, disposal, 

or radioactive decay. These methods help to ensure that possession limits are not exceeded. 

Individual AUs should be able to account for all materials in their possession, whether the 

material is in solid, liquid, or gas form; whether it is possessed in a stock vial or dispersed in 

samples, or placed into waste containers in the AU’s laboratory. The ARDL licensee should be 

able to account for the location of all materials possessed, whether the material is located in a 

secured laboratory cabinet, a locked sample container in a refrigerator or freezer, or appropriate

waste containers awaiting disposal. The RSO should periodically update the total inventory of 

all unsealed materials possessed under the license. Depending on the how often unsealed 

materials are received and used, the periodic update may be weekly, monthly, quarterly, or at 

less frequent intervals. 

NRC regulations applicable to transfers are stated in 10 CFR 30.41, “Transfer of byproduct 

material.” Sample policy transfer statements are included in Appendix K. Transfer of licensed 

materials within the facility may require special procedures to ensure proper control. In many 

facilities, pieces of laboratory equipment or components, including refrigerators and freezers,

will become contaminated. Removal of these items for maintenance, repair, or disposal also 

should be carefully controlled.

Licensees must maintain records of receipt, transfer, and disposal (as waste) of all licensed 

material. Table 8.4 lists each type of record and how long the record must be maintained. 

Other records, such as transfer records, could be linked to radioactive material inventory 

records. Receipt records also should document cases in which excessive radiation levels or 

radioactive contamination were found on packages or containers of material received and 

describe the action taken.

Table 8.4 Record Maintenance

Type of Record How Long Record Must be Maintained

Receipt For as long as the material is possessed until 3 years after 

transfer or disposal

Transfer For 3 years after transfer

Disposal Until NRC terminates the license

Important to decommissioning Until the site is released for unrestricted use
52

Receipt, transfer, and disposal records typically contain the following information:

• radionuclide and activity (in units of becquerels or curies), and date of measurement of 

byproduct material

• manufacturer, model number, location for each sealed source, and, if needed for 

identification, serial number, and as appropriate, manufacturer and model number of 

device containing the sealed source

• date of the transfer and name and license number of the recipient, and description of the 

affected radioactive material (e.g., radionuclide, activity, manufacturer’s name and model 

number, serial number)

• for licensed materials disposed of as waste, include the radionuclide, activity, date of 

disposal, and method of disposal (decay, sewer, etc.)

See the section on “Waste Disposal” for additional information.

Information on locations where licensed material is used or stored are among the records 

important to decommissioning and are required by 10 CFR 30.35(g). See also the section on 

“Financial Assurance and Record Keeping for Decommissioning.”

Response from Applicant:

• State that: “We will develop, implement, and maintain procedures for ensuring 

accountability of licensed materials at all times.”

AND

• Provide either of the following:

− A statement that: “Physical inventories will be conducted at intervals not to exceed 

6 months, to account for all sealed sources and devices received and possessed 

under the license. Records of inventory shall be maintained for a period of 5 years 

from the date of each inventory, and shall include the radionuclides, quantities, 

manufacturer’s name and model numbers, and the date of the inventory.”

OR

− A description of the procedures for ensuring that no sealed sources have been lost, 

stolen, or misplaced

Note:

• No response is needed from applicants for package opening procedures. Package 

opening procedures are reviewed during NRC inspections to ensure compliance with 10 

CFR 20.1906.
53

• Alternative responses will be evaluated using the criteria listed above.

References:

• NUREG-1516, “Management of Radioactive Material Safety Programs at Medical 

Facilities,” May 1997.

• NCRP Report No. 114, “Maintaining Radiation Protection Records,” 1992.

• NCRP Report No. 105, “Radiation Protection for Medical and Allied Health Personnel,” 

1989.

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

• NCRP Report No. 157, “Radiation Protection in Educational Institutions,” 2007.

8.10.4 Occupational Dose 

Regulations: 10 CFR 20.1501, 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR 20.1202, 

10 CFR 20.1203, 10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1703, 

10 CFR 20.2105, 10 CFR 20.2206, 10 CFR Part 20, Appendix B

Criteria: The use of individual monitoring devices for external dose is required for:

• Adults likely to receive an annual dose in excess of any of the following (each evaluated 

separately):

− 5 mSv (0.5 rem) deep-dose equivalent

− 15 mSv (1.5 rems) eye dose equivalent

− 50 mSv (5 rems) shallow-dose equivalent to the skin

− 50 mSv (5 rems) shallow-dose equivalent to any extremity

• Minors likely to receive an annual dose in excess of any of the following (each evaluated 

separately):

− 1.0 mSv (0.1 rem) deep-dose equivalent

− 1.5 mSv (0.15 rem) eye dose equivalent

− 5 mSv (0.5 rem) shallow-dose equivalent to the skin

− 5 mSv (0.5 rem) shallow-dose equivalent to any extremity

• Declared pregnant women likely to receive an annual dose from occupational exposures 

in excess of 1.0 mSv (0.1 rem) deep-dose equivalent, although the dose limit applies to 

the entire gestation period

• Individuals entering a high or very high radiation area
54

Internal exposure monitoring (not necessarily individual monitoring devices) is required for:

• Adults likely to receive in 1 year an intake in excess of 10 percent of the applicable ALIs 

for ingestion and inhalation.

• Minors and declared pregnant women likely to receive in 1 year a committed effective 

dose equivalent in excess of 1.0 mSv (0.1 rem).

Figure 8.7 Annual Dose Limits for Occupationally Exposed Individuals

Discussion:

Total dose equivalent (TEDE) equals deep dose from external exposure plus dose from

internally deposited radionuclides.

According to 10 CFR 20.1502, “Conditions requiring individual monitoring of external and 

internal occupational dose,” if an adult (individual) is likely to receive in 1 year a dose greater 

than 10 percent of any applicable limit (see Figure 8.7 for annual dose limits), monitoring for 

occupational exposure is required. The licensee should perform an evaluation of the dose the 

individual is likely to receive before allowing the individual to receive the dose. This evaluation 

does not have to be made for every individual; evaluations can be made for employees with 

similar job functions or work areas. Regulatory Guide 8.34, “Monitoring Criteria and Methods to 

Calculate Occupational Doses,” dated July 1992, provides further guidance on evaluating the 

need to provide monitoring.

If this prospective evaluation shows that the individual’s dose is not likely to exceed 10 percent 

of any applicable regulatory limit, there are no recordkeeping or reporting requirements. For 

individuals who have received doses at other facilities in the current year, the previous dose 

does not have to be considered in this prospective evaluation. When determining the need for 

monitoring, only a dose that could be received at the applicant or licensee’s facilities performing 

the evaluation needs to be considered, including any recordkeeping and reporting requirements. 

If an evaluation determined that monitoring was not required and a subsequent evaluation 
55

indicates that the 10 percent regulatory threshold may or will be exceeded, the dose the

individual received when monitoring was not provided should be estimated, recorded, and 

reported (if required). These estimates can be based on any combination of work location 

radiation monitoring, survey results, monitoring results of individuals in similar work situations, 

or other estimates to produce a “best estimate” of the actual dose received.

If monitoring is not required to demonstrate compliance with all limits but is required relative to 

one or more specific limits, the licensee should enter “NR” for “Not Required” in the blocks on 

NRC Forms 4 and 5 to indicate the areas for which monitoring was not required (e.g., extremity 

or skin doses). The licensee should enter “ND” for “Not Detectable where monitoring was 

provided but not measurable.”

If the prospective dose evaluation shows that the individual is likely to exceed 10 percent of an 

applicable limit, monitoring is required (10 CFR 20.1502). Recordkeeping of the results of 

monitoring performed regardless of the actual dose received, is required by 10 CFR 20.2106(a).

A common method for dose evaluation is to monitor workers’ dose with whole body and 

extremity dosimetry (e.g., optically-stimulated luminescence dosimeter (OSL), 

thermoluminescent dosimeter (TLD), film, ring badge) that a National Voluntary Laboratory 

Accreditation Program (NVLAP)-approved dosimetry service provides. Workers typically are 

monitored for a year or more to determine actual annual dose. The monitoring results are then 

used to determine the need to continue monitoring workers. The dose to workers may need to 

be reevaluated if the licensee’s program changes (e.g., procedures, frequency of use, quantity 

of licensed material used, isotopes used).

Regulatory Guide 8.34 and Regulatory Guide 8.9, “Acceptable Concepts, Models, Equations, 

and Assumptions for a Bioassay Program,” dated July 1993, provide guidance on

methodologies for determination of internal occupational dose and summation of occupational 

dose. The NRC also has developed additional regulatory guides for specific isotopes such as 

H-3 and iodine. Contact the appropriate NRC regional office or contact the NRC’s Web site, 

http://www.nrc.gov, for copies of these guidance documents.

Response from Applicant: Provide either of the following:

• A statement that: “We have done a prospective evaluation and determined that 

unmonitored individuals are not likely to receive, in 1 year, a radiation dose in excess of 

10 percent of the allowable limits in 10 CFR Part 20,” or “We will monitor individuals in 

accordance with the criteria in the section, ‘Radiation Safety Program–Occupational 

Dose’ in NUREG-1556, Volume 7, Revision 1, ‘Consolidated Guidance about Materials 

Licenses: Program-Specific Guidance about Academic, Research and Development 

and Other Licenses of Limited Scope.’”.

OR

• A description of an alternate method for demonstrating compliance with the referenced 

regulations.
56

Note:

• Alternative responses will be evaluated using the criteria listed above.

• Some licensees choose to provide personnel dosimetry to their workers for reasons 

other than compliance with NRC requirements (e.g., to respond to worker requests).

References: See the notice of availability on the inside front cover of this report to obtain 

copies of:

• Regulatory Guide 8.7, “Instructions for Recording and Reporting Occupational Radiation 

Dose Data,” dated November 2005.

• Regulatory Guide 8.9, “Acceptable Concepts, Models, Equations, and Assumptions for a 

Bioassay Program,” Revision 1, July 1993.

• Regulatory Guide 8.34, “Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses,” July 1992.

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

Criteria: Licensees must ensure that licensed material will be used, transported, stored, and 

disposed of in such a way that members of the public will not receive more than 1 mSv 

(100 mrem) in 1 year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) 

in any 1 hour, from licensed operations.

Discussion: “Public dose” is defined in 10 CFR Part 20 as “the dose received by a member of 

the public from exposure to radiation and/or 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) the individual is in when the dose 

is received.

Appendix L provides guidance on accepted methodologies for determining dose to members of 

public.

Figure 8.8 shows the steps to calculate the annual dose to an individual member of the public.
57

Figure 8.8 Calculating Public Dose

Steps to calculate the annual dose to an individual member of the public 

(see Appendix L for more information about occupancy factors).

Many possible internal dose pathways contribute to the TEDE. The TEDE can, however, be 

broken down into three major dose pathway groups:

• airborne radioactive material

• waterborne radioactive material

• external radioactive exposure

The licensee should review these major pathways and decide which are applicable to its 

operations.
58

Licensees should design a monitoring program to ensure compliance with 10 CFR 20.1302(b). 

The extent and frequency of monitoring will depend on each licensee’s needs. Refer to Section 

8.10.7, “Radiation Safety Program–Surveys” for additional guidance on monitoring of effluents. 

Regulations in 10 CFR 20.2107, “Records of dose to individual members of the public,” require 

licensees to maintain records sufficient to demonstrate compliance with the dose limits for 

members of the public until the Commission terminates the license. These records should be 

available for review during NRC inspections. Appendix L provides additional guidance on 

compliance with the recordkeeping requirements.

Response from Applicant: No response is required from the applicant in a license application, 

but compliance will be examined during inspection. During NRC inspections, licensees must be 

able to demonstrate, by measurement or calculation, that the TEDE 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 for examples of methods to demonstrate compliance.

8.10.6 Safe Use of Radionuclides and Emergency Procedures 

Regulations: 10 CFR 30.34(e), 10 CFR 20.1101, 10 CFR 20.1406, 10 CFR 20.1801, 

10 CFR 20.1802, 10 CFR 20.1902-1905, 10 CFR 20.2201-2203, 10 CFR 30.32(i), 

10 CFR 30.50, 10 CFR 30.72, 10 CFR 21.21, 10 CFR 19.11(a)(3)

Criteria: Licensees are required to do all of the following:

• keep radiation doses to workers and members of the public ALARA

• ensure security of licensed material

• make the required notifications of events to the NRC

Discussion: Licensees are responsible for the security and safe use of all licensed material 

from the time it arrives at their facility, during its use and storage, and until it is transferred or 

disposed. Licensees should develop, implement and maintain written procedures to ensure 

safe use of licensed material. The procedures also should include operational and 

administrative guidelines. The written procedures should provide reasonable assurance that 

only appropriately trained personnel will handle and use licensed material without undue hazard 

to workers or members of the public.

General Safety Procedures

The written procedures should include the following elements:

• contamination controls

• waste disposal practices

• personnel and area monitoring (including limits)

• use of protective clothing and equipment

• recordkeeping requirements

• reporting requirements

• responsibilities

These procedures should include policies for:
59

• frequency of personnel monitoring

• use of appropriate shielding (see Figure 8.9)

• frequent change of gloves to minimize exposure to the individual and to avoid spread of 

contamination in the laboratory

Applicants also should develop radionuclide-specific procedures based on the respective 

hazards associated with the radionuclides. Appendix M describes general safety guidelines. 

Applicants should use these guidelines to develop procedures for the safe use of radionuclides.

Licensees should determine if they have areas that require posting in accordance with 

10 CFR 20.1902, “Posting requirements,” unless they meet the exemptions listed in 

10 CFR 20.1903, “Exceptions to posting requirements.” Also, containers of licensed material 

(including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, “Labeling 

containers,” unless they meet the exemptions in 10 CFR 20.1905, “Exemptions to labeling 

requirements.”

Figure 8.9 Use of Appropriate Shielding

This worker is using high-density plastic shielding, 

which is appropriate for radionuclides that emit beta radiation.
60

Security Procedures

Per 10 CFR 20.1801 requirements, licensees must secure all licensed materials stored in 

controlled or unrestricted areas from unauthorized access or removal. When any licensed

materials are in controlled or unrestricted areas, but are not in use, the licensee must control 

and maintain them through constant surveillance of the materials per 10 CFR 20.1802. These 

security requirements are intended to ensure that individuals who are not knowledgeable about 

radioactive materials cannot be exposed to or contaminated by the material and cannot take the 

material. Acceptable methods for securing material will vary among facilities. Some 

alternatives licensees use include: storage and use of licensed materials only in restricted 

areas; limiting access to an entire facility, building, or portion of the building only to radiation 

workers; providing locked storage areas to prevent access to the material; and implementing 

procedures that require a radiation worker to be with “line of sight” of the materials whenever 

licensed materials are in use. Applicants should develop procedures that clearly state 

acceptable methods to secure licensed material at their facility. Particular attention to security 

procedures may be required at facilities that may have unusual needs because of the activities 

performed, such as hot cells, animal care facilities, and waste processing facilities.

Emergency Procedures

Accidents and emergencies can happen during any operation with radionuclides, including their 

transportation, use, transfer, and disposal. Such incidents can result in contamination or 

release of material to the environment, and unintended radiation exposure to workers and 

members of the public. In addition, loss or theft of licensed material, sabotage, fires, floods, 

etc., can adversely affect the safety of personnel and members of the public. Therefore, it is 

necessary to develop written procedures to minimize, as much as possible, the effect of these 

incidents on personnel, members of the public, and the environment. Applicants that plan to 

possess quantities of material in excess of the applicable amounts listed in 10 CFR 30.72 

Schedule C also may be required to submit an “Emergency Response Plan for Responding to a 

Release.”

Applicants should establish written procedures to handle events ranging from a minor spill 

(see Figure 8.10) to a major accident that may require outside emergency response personnel 

intervention. These procedures should include provisions for immediate response, after-hours 

notification, handling of each type of emergency and equipment, and the appropriate roles of 

users and the radiation safety staff. Except for minor spills or releases of radioactivity that the 

user can control and clean up, the licensee’s staff should have a clear understanding of their 

role in an emergency with step-by-step instructions and clear direction on whom to contact.

Licensees should have a sufficient number of appropriate and calibrated survey instruments

readily available. Emergency spill kits should be strategically placed in well-marked locations 

for all users and radiation safety staff to use. All equipment should be inspected periodically for 

proper operation and replenished as necessary. Appendix M includes model emergency 

procedures. Applicants may adopt these procedures or develop their own, incorporating the 

safety features included in these model procedures.
61

Collection of Bioassay Samples

In the event of an emergency in which an individual becomes contaminated and radioactive 

material is taken into the body through skin absorption or other means, or is suspected of 

having ingested or inhaled radioactive material, an estimate of the amount of material taken into 

the body may be required. Frequently, this estimate is made by performing bioassay of the 

individual. Bioassays may be performed through direct methods such as whole body counting 

or thyroid counting, in which the radioactive material in the body can be directly measured using 

appropriate instruments. Bioassays also may be performed indirectly by sampling urine or other 

excreta from the body, and calculating the intake from the amount of material detected in the 

samples, the time between suspected intake and sample collection, and knowledge of the rate 

of excretion of the compound or radionuclide from the body. While there are many ways to 

perform the calculations, including using computer models, the method of calculation is only as 

good as the quality of the samples and analyses performed. Because a dose estimate may be 

required, bioassay procedures for a suspected intake may differ from those in a routine 

bioassay screening program, and the radiation safety program should include procedures and 

equipment for appropriate sample collection in an emergency. The following items should be 

considered in developing procedures:

• type of bioassay that must be performed (direct or indirect)

• number of samples or data points to be collected

• frequency of sampling (e.g., hourly, daily, weekly, once, )

• size of the sample to be collected (24-hour urine collection?)

• ease or difficulty of sample collection

• need for written instructions for the sample collector, who may be the contaminated 

individual
62

Figure 8.10 Proper Handling of Incident

Panels 1 and 2 indicate how contamination can be spread 

if the incident is not handled properly as in panels 3 and 4.

Response from Applicant: The applicant must state that procedures for safe use, security of 

materials, and emergencies have been developed, or will be developed before receipt of 

licensed material; and that the procedures will be implemented and maintained. If an 

“Emergency Response Plan” is required for your license under 10 CFR 30.32(i), submit it as a 

separate part of the application. If you want the option to make changes in the procedures, 

submit a statement that,:, “Procedures may be revised only if (1) the licensee management and 

the RSO have reviewed and approved the changes in writing; (2) the licensee staff is provided 

training in the revised procedures before implementation; (3) the changes are in compliance 

with the NRC regulations and the license; and (4) the changes do not degrade the effectiveness 

of the program.”

8.10.7 Surveys 

Regulations: 10 CFR 30.36(j-k), 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.1906, 

10 CFR 20.2103

Criteria: Licensees are required by 10 CFR 20.1501, “General,” to make surveys of potential 

radiological hazards in their workplace. The NRC requires testing to determine whether there is 

any radioactive leakage from sealed sources. Records of surveys and leak tests results must 

be maintained.
63

Discussion: Surveys are evaluations of radiological conditions and potential hazards 

(see Figure 8.11). These evaluations may be measurements (e.g., radiation levels measured 

with survey instrument or results of wipe tests for contamination), calculation, or a combination 

of measurements and calculations. The selection and proper use of appropriate instruments is 

one of the most important factors in ensuring that surveys accurately assess the radiological 

conditions. In order to meet regulatory requirements for surveying, measurements of 

radiological quantities should be understood in terms of their properties (i.e., alpha, beta, 

gamma) and compared to the appropriate limits.

Figure 8.11 Types of Surveys

ARDL licensees perform many different types of surveys.

Radiation surveys are used to detect and evaluate contamination of:

• facilities

• equipment

• personnel (during use, transfer, or disposal of licensed material) (see Figure 8.12)

• restricted and unrestricted areas

Surveys also are used to plan work in areas where licensed material or radiation exists and to 

evaluate doses to workers and individual members of the public.
64

Figure 8.12 Personnel Surveys

Users of unsealed licensed material should check themselves 

for contamination (frisk) before leaving the laboratory.

As stated in 10 CFR 20.1501, surveys are required when it is reasonable under the 

circumstances to evaluate a radiological hazard and when necessary for the licensee to comply 

with the regulations. Many different types of surveys may need to be performed because of the 

particular use of licensed materials. The most important are as follows:

• Surveys for radioactive contamination that could be present on surfaces of floors, walls, 

laboratory furniture, and equipment.

• Measurements of radioactive material concentrations in air for areas where radioactive 

materials are handled or processed in unsealed form, where operations could expose 

workers to the inhalation of radioactive material, or where licensed material is or could 

be released to unrestricted areas.

• Measurements of radioactive material concentrations in water released to the 

environment or to the sanitary sewer.

• Bioassays to determine the kinds, quantities, or concentration, and, in some cases, the 

location of radioactive material in the human body. A bioassay can be made by direct 

measurement (in vivo counting) or by analysis and evaluation of material excreted or 

removed from the human body.

• Surveys of external radiation exposure levels in both restricted and unrestricted areas.

The frequency of routine surveys depends on the nature, quantity, and use of radioactive 

materials, as well as the specific protective facilities, equipment, and procedures designed to 
65

protect the worker from external and internal exposure. Also, the frequency of the survey 

depends on the type of survey, such as those listed above. (See Appendix N)

Not all instruments can measure a given type of radiation. The presence of other radiation may 

interfere with a detector’s ability to measure the radiation of interest. Correct use of radiation 

detection and measurements is an important aspect of any radiation safety program.

Regulations in 10 CFR Part 20 do not specify limits for surface contamination. Each applicant 

should propose and justify what removable surface contamination limits will be allowable before 

decontamination will be performed in each work area. Table N.2 and Table N.3 in Appendix N

contain contamination limits acceptable to the NRC.

Sealed Source and Plated Foil Leak Test

When issued, a license will require performance of leak tests of sealed and plated foil sources 

(e.g., ECD/XRF) at intervals as approved by NRC or an Agreement State and specified by the 

SSD registration certificate. The measurement of the leak-test sample is a quantitative analysis 

requiring that instrumentation used to analyze the sample be capable of detecting 

185 Bq (0.005 μCi) of the radionuclide contained in the source or foil.

The NRC or an Agreement State may authorize manufacturers, consultants, and other 

organizations to either perform the entire leak test sequence for other licensees or provide leak 

test kits to licensees. In the latter case, the licensee is expected to take the leak test sample 

according to the sealed source or plated foil manufacturer’s (distributor’s) and the kit supplier’s 

instructions and return it to the kit supplier 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. Licensees also may be authorized to conduct the 

entire leak test sequence themselves.

Leak tests are not required if:

• sources contain only H-3

• sources contain only byproduct material with a half-life of less than 30 days

• sources contain only a radioactive gas

• sources contain 3.7 MBq (100 μCi) or less of beta-emitting or gamma-emitting material 

or 370 kBq (10 μCi) or less of alpha-emitting material

• sources are stored and not being used (must be leak tested before use or transfer)

Sealed sources and devices approved by the NRC or an Agreement State and located and 

used according to their SSD registration certificates usually pose little risk of contamination. 

Leak tests performed as specified in the SSD registration certificate should identify defective 

sources. Leaking sources must be withdrawn immediately from use and decontaminated, 

repaired, or disposed of according to NRC requirements. These steps minimize the spread of 
66

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.

See Appendix O for more information on leak tests.

Response from Applicant: Choose one of the following:

• State: “We will survey our facility and maintain contamination levels in accordance with 

the survey frequencies and contamination levels published in Appendix N in 

NUREG-1556, Volume 7, Revision 1, ‘Program-Specific Guidance about Academic, 

Research and Development, and Other Licenses of Limited Scope’ Leak tests will be 

performed at the intervals approved by NRC or an Agreement State and specified in the 

SSD registration certificate.” 

AND

• If leak tests will be analyzed by an outside entity, state: “Leak tests will be analyzed by 

an organization authorized by NRC or an Agreement State to provide leak testing 

services to other licensees. Leak tests may be collected by the applicant, using a leak 

test kit supplied by an organization authorized by the NRC or an Agreement State, to 

provide leak test kits to other licensees and according to the sealed source or plated foil 

manufacturer’s (distributor’s) and kit supplier’s instructions.”

OR

• If leak tests will be analyzed by the applicant, state: “We will implement the model leak 

test program published in Appendix O in NUREG-1556, Volume 7, Revision 1, 

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

Academic, Research and Development, and Other Licensees of Limited Scope.’”

OR

• Submit description of alternative equipment or procedures to evaluate a radiological 

hazard and for determining whether there is radioactive leakage from sealed sources or 

plated foil.

Note:

• Alternative responses will be reviewed using the criteria listed above.

• If a sealed source or plated foil is added to an existing license then that license might 

already authorize the licensee to perform the entire leak test sequence. In this case, the 

licensee may perform the leak testing on the sealed source or plated foil according to the 

procedures previously approved on its license.
67

Reference: See NUREG-1556, “Consolidated Guidance about Materials Licenses: 

Program-Specific Guidance about Service Provider Licenses,” Volume 18, for guidance on 

obtaining a license to perform leak testing as a service to others.

8.10.8 Transportation 

Regulations: 10 CFR 71.5, 10 CFR 71.12, 10 CFR 71.13, 10 CFR 71.14, 71.47, 71.87, 

49 CFR Parts 171-178, 10 CFR 20.1101, 10 CFR 30.41, 10 CFR 30.51, 49 CFR Parts 172, 173, 

177.

Criteria: Applicants that will transport or ship licensed material, including radioactive waste, 

must develop, implement, and maintain safety programs for transport of radioactive material to 

ensure compliance with NRC and DOT regulations.

Discussion: 

Licensed material, including radioactive waste, must be packaged and transported in 

accordance with NRC and DOT requirements if the transportation involves common carriers or 

the use of public highways. Licensees should develop and maintain their own radiation safety 

procedures for transporting licensed material within their own facilities if it does not involve the 

use of public highways. 

Packages that ARDL licensees ship frequently meet the “Limited Quantity” criteria as described 

in 49 CFR 173.421, “Excepted packages for limited quantities of Class 7 (radioactive) 

materials,”. Therefore, they may be subject to DOT requirements which may 

include 49 CFR 173.422, “Additional requirements for excepted packages for limited quantities 

of Class 7 (radioactive) materials,” and 49 CFR 173.424; “Excepted packages for radioactive 

instruments and articles”. See Appendix P for more information. Packages requiring a DOT 

White-I, Yellow-II or Yellow-III label have additional DOT requirements. Under 49 CFR 

172.704—“Training requirements,” each person (shipper or carrier) involved in the 

transportation of radioactive materials must receive appropriate training for the jobs the

employee performs related to transportation, every 3 years. These jobs include activities such 

as packaging radioactive materials, loading and securing the package on a vehicle, or

preparation of paperwork for shipping the material.

Licensees should consider the safety of all individuals who may handle or may come into 

contact with the packages containing licensed material. Therefore, the primary considerations 

in packaging licensed material should be to ensure that the package integrity is not 

compromised during transport, and that radiation levels (including removable contamination 

levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, but 

are ALARA.

All domestic shipping papers and labels must be in SI units only or must be in SI units first with 

English units in parenthesis.

Licensees shipping radioactive waste for disposal must prepare appropriate documentation as 

specified in Appendix G, “Requirements for Transfers of Low-Level Radioactive Waste Intended 

for Disposal at Licensed Land Disposal Facilities and Manifests” to 10 CFR Part 20.
68

Response from Applicant: No response is needed from applicants during the licensing phase. 

Transportation issues are reviewed during inspections.

Reference: “A Review of Department of Transportation Regulations for Transportation of 

Radioactive Materials (1998 revision)” can be obtained by calling DOT’s Office of Hazardous 

Safety Administration Training at 202-366-4900. Publications, guidance, and training materials 

can be found at the DOT Web site http://phmsa.dot.gov/hazmat/training/publications.

8.10.9 Security Program for Category 1 and Category 2 Materials

Regulations: 10 CFR 20.2207, 10 CFR Part 37 

Criteria: Licensees must ensure the security and control of licensed material. 

Note: The requirements in 10 CFR 20.2207 are only applicable to those licensees that possess 

Category 1 and Category 2 sources. The regulations in 10 CFR Part 37, “Physical Protection of 

Category 1 and Category 2 Quantities of Radioactive Material,” apply to licensees that possess 

an aggregate amount of category 1 or category 2 quantity of radioactive material.

Discussion: 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 an NSTS report. The NSTS is a major security initiative of the NRC. The NSTS is a 

secure, accessible and easy-to-use computer system that tracks high-risk radioactive sources 

from the time they are manufactured or imported through the time of their disposal or export, or 

until they decay enough to no longer be of concern.

In accordance with 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 

Quantities of Radioactive Material,” licensees authorized to possess Category 1 or Category 2 

quantities of radioactive material must establish, implement, and maintain a security program to 

ensure physical protection of the radioactive material. For additional guidance 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.”

Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37 

lists Category 1 and 2 threshold quantities of radioactive material. The applicant should refer to 

this table to determine if its program exceeds the Category 1 or Category 2 authorization 

thresholds.

If licensees possess, ship, or receive quantities of material exceeding Category 1, then they 

must also comply with requirements specific to Category 1 quantities. Refer to 10 CFR Part 37 

for these additional requirements. 
69

Per 10 CFR Part 37, Subpart B, licensees must establish an access authorization program to 

ensure that individuals who have unescorted access to Category 1 and 2 quantities of 

radioactive material and reviewing officials are trustworthy and reliable. 

Per 10 CFR Part 37, Subpart C, licensees must establish a physical protection program 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 in use or 

storage. 

Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

Category 2 quantity of radioactive materials in transit. These requirements apply to a person 

delivering material to a carrier for transport, as well as cases in which the person transports 

material.

Note: Refer to 10 CFR Part 37 and associated guidance in NUREG-2155 for additional details 

on security guidance.

Response from Applicant:

No response is required from an applicant or licensee that would become newly subject to 

10 CFR Part 37.

8.11 Item 11: Waste Management

Regulations: 10 CFR 20.1904, 10 CFR 20.2001, 10 CFR 20.2002, 10 CFR 20.2003, 

10 CFR 20.2004, 10 CFR 20.2005, 10 CFR 20.2006, 10 CFR 20.2007, 10 CFR 20.2108, 

10 CFR 30.51, 10 CFR 61.52

Criteria: Radioactive waste must be disposed of in accordance with regulatory requirements 

and license conditions. Appropriate records of waste disposal must be maintained.

Discussion: Radioactive waste is normally generated when conducting licensed activities. 

Such waste may include used or unused radioactive material, unusable items contaminated with 

radioactive material (e.g., absorbent paper, gloves). Licensees may not receive radioactive 

waste from other licensees for processing, storage, or disposal, unless the NRC specifically 

authorizes them to do so.

All radioactive waste must be stored in appropriate containers until its disposal. The integrity of 

the waste containers must be assured. Radioactive waste containers must be appropriately 

labeled. All radioactive waste must be secured against unauthorized access or removal. 

Licensees may implement procedures to reduce the volume of radioactive waste for final 

disposal in an authorized low-level radioactive waste (LLW) disposal facility. These procedures 

include volume reduction by segregating, consolidating, compacting, or allowing certain waste 

to decay in storage (DIS). Waste compaction or other treatments can reduce the volume of 

radioactive waste, but such processes may pose additional radiological hazards (e.g., airborne 
70

radioactivity) to workers and members of the public. The program should include adequate 

safety procedures to protect workers, members of the public, and the environment.

NRC requires ARDL licensees to dispose of radioactive waste generated at their facilities 

through one or more of the following methods:

• decay-in-storage 

• release into sanitary sewerage

• transfer to an authorized recipient

• disposal of waste as if it were not radioactive (specific wastes)

• obtaining prior approval of NRC of any alternate method

• release in effluents to unrestricted areas, other than into sanitary sewerage

• incineration

Licensees may choose one or more of these methods to dispose of their radioactive waste. The 

NRC has observed that that most ARDL facilities store or dispose of radioactive waste through

a combination of the first four methods, because of the types and amounts of licensed materials 

these facilities use. Applicants that want to dispose of radioactive waste by incineration should 

refer to Policy and Guidance Directive PG 8-10, “Disposal of Incinerator Ash as Ordinary 

Waste,” issued January 1997. Applicants should note that compliance with NRC regulations 

does not relieve them of their responsibility to comply with any other applicable Federal, State, 

or local regulations. Furthermore, some of the radioactive waste also may include additional 

hazards, (e.g., biohazard or chemical hazard). Such waste is called “mixed waste,” and its 

storage and disposal must also comply with all other applicable Federal, State, and local 

regulatory requirements.

Applicants should describe their program for management and disposal of radioactive waste. 

The program should include procedures for handling of waste, safe and secure storage, 

characterization, minimization, and disposal of radioactive waste. Appropriate training should 

be provided to waste handlers. Regulations require that licensees maintain all appropriate 

records of disposal of radioactive waste. The U.S. Environmental Protection Agency issued 

guidance for developing a comprehensive program to reduce hazardous waste that, in many 

instances, also may include radioactive waste. The NRC transmitted these guidelines to 

licensees in IN-94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste Generators on 

the Elements of a Waste Minimization Program,” dated March 25, 1994.

Licensees that do not have access to a radioactive waste facility may have to store waste for 

long periods of time. The NRC has developed guidance for such extended interim storage of 

waste, discussed below. 

Disposal by Decay in Storage 

The NRC has concluded that materials with half-lives of less than or equal to 120 days are 

appropriate for DIS. The holding time of the waste should be based on the radionuclide(s), 

half-life, and the activity present when the waste was placed into storage. Such waste may be 

disposed of as ordinary trash if radiation surveys (performed in a low background area and 

without any interposed shielding) of the waste at the end of the holding period indicate that 
71

radiation levels are indistinguishable from background. All radiation labels must be defaced or 

removed from containers and packages before disposal as ordinary trash. If the decayed waste 

is compacted, all labels visible in the compacted mass also must be defaced or removed.

Applicants should ensure that adequate space and facilities are available for the storage of such 

waste. Licensees can minimize the need for storage space, if the waste is segregated 

according to physical half-life. Waste containing radionuclides of physical half-lives within a 

certain range may be stored in one container and allowed to decay in the container. 

Procedures for management of such waste should include methods of segregation, surveys 

before disposal, and maintenance of records of disposal. Records should include the date 

when the waste was put in storage for decay, date of disposal, and results of final survey before 

disposal as ordinary trash. Appendix Q provides a model procedure for disposal of radioactive 

waste by DIS, which incorporates the above guidelines.

Release into Sanitary Sewerage

Regulations in 10 CFR 20.2003, “Disposal by release into sanitary sewage,” authorize disposal 

of radioactive waste by release into a public sanitary sewerage system if each of the following 

conditions is met:

• Material is readily soluble (or is readily dispersible biological material) in water.

• Quantity of licensed material that the licensee releases into the sewer each month 

averaged over the monthly volume of water released into the sewer does not exceed the 

concentration specified in Table 3 of Appendix B, “Annual Limits on Intake (ALIs) and 

Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent 

Concentrations; Concentrations for Release to Sewerage,” to 10 CFR Part 20.

• If more than one radionuclide is released, the sum of the ratios of the average monthly 

discharge of a radionuclide to the corresponding limit in Table 3 of Appendix B to 

10 CFR Part 20 cannot exceed unity.

• Total quantity of licensed material released into the sanitary sewerage system in a year 

does not exceed 185 GBq (5 Ci) of H-3, 37 GBq (1 Ci) of C-14, and 37 GBq (1 Ci) of all 

other radionuclides combined.

Licensees are responsible for demonstrating that licensed materials discharged into the public 

sewerage system are readily soluble in water. NRC IN 94-07, “Solubility Criteria for Liquid 

Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR 20,” dated 

January 28, 1994, provides acceptable criteria for evaluating solubility of wastes released to the 

sewer. Careful consideration should be given to the possibility of reconcentration of 

radionuclides released into the sewer. The NRC alerted licensees to the potentially significant 

problem of reconcentration of radionuclides released to sanitary sewerage systems in IN 84-94, 

“Reconcentration of Radionuclides Involving Discharges into Sanitary Sewerage Systems 

Permitted under 10 CFR 20.303 (now 10 CFR 20.2003),” dated December 21, 1984.
72

Applicants should provide procedures that will ensure that all releases of radioactive waste into 

the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the 

monthly and annual limits specified in regulations. Licensees are required to maintain accurate 

records of all releases of licensed material into the sanitary sewerage. Appendix Q describes a

model program for disposal of radioactive waste through sanitary sewer.

Transfer to an Authorized Recipient

Licensees may transfer radioactive waste to an authorized recipient for disposal. The licensee

is responsible for verifying that the intended recipient is authorized to receive the radioactive 

waste before shipment. The waste must be packaged in approved containers for shipment, and 

each container must identify the radionuclides and the amounts contained in the waste. 

Additionally, packages must comply with the requirements of the particular burial site’s license 

and State requirements. Each shipment must comply with all applicable NRC and DOT 

requirements. In some cases, the waste handling contractor may provide guidance to the 

licensee for packaging and transportation requirements; however, the licensee is ultimately 

responsible for ensuring compliance with all applicable regulatory requirements.

The shipper must provide all information required in NRC s Uniform Low-Level Radioactive 

Waste Manifest, and transfer this recorded manifest information to the intended recipient in 

accordance with Appendix G to10 CFR Part 20. Each shipment manifest must include a 

certification by the waste generator, as specified in Section II of the appendix. Each person 

involved in the transfer for disposal and disposal of waste, including waste generator, waste 

collector, waste processor, and disposal facility operator, must comply with requirements 

specified in Section III of Appendix G.

Disposal of Specific Waste as If It Were Not Radioactive

The following radioactive wastes may be disposed of as nonradioactive waste pursuant to 

10 CFR 20.2005, “Disposal of specific wastes”:

• Liquid scintillation media (including vials and other items contaminated with liquid 

scintillation media) containing no more than 1.85 kBq (0.05 μCi) of H-3 or C-14 per gram 

of the medium.

• Animal carcasses or animal tissue containing no more than 1.85 kBq (0.05 μCi) of H-3 or 

C-14 per gram averaged over the weight of the entire animal.

The regulations in 10 CFR 20.2003 are not applicable to releases to a private sewerage 

treatment system, a septic system, or leach fields. Licensees may make releases to these 

systems as effluents released to unrestricted areas pursuant to 10 CFR 20.1301. 

However, if licensed material is released to a private sewage treatment system, septic 

system, or leach field, the sludge or other solids from these systems may become 

contaminated with radioactive material. Such sludges may be required to be disposed of 

as radioactive waste, using one of the methods described in Section 8.11 of this document.
73

Applicants should have procedures to ensure that the above limits are not exceeded, and that 

animal tissue or carcasses containing licensed material are disposed of in a way that will not 

permit their use either as food for humans or animals. Applicants must maintain accurate 

records of these disposals.

Alternate Methods

Applicants also may request alternate methods under 10 CFR 20.2002, “Method for obtaining 

approval of proposed disposal procedures,” for the disposal of radioactive waste generated at 

their facilities. Such requests must describe the waste containing licensed material, including 

the physical and chemical properties that may be important to assess risks associated with the 

waste, and the proposed manner and conditions of waste disposal. Additionally, the applicant 

must submit its analysis and evaluation of pertinent information on the nature of the 

environment, the nature and location of other affected facilities, and procedures to ensure that 

radiation doses are maintained ALARA and within regulatory limits. An applicant cannot make 

such disposals until the NRC has reviewed and approved the request.

Extended Interim Storage

Some licensees do not have an LLW disposal facility available; therefore, they must use onsite 

interim storage until a facility becomes available. Licensees should exhaust all possible 

alternatives for disposal of radioactive waste and rely on onsite extended interim storage of 

radioactive waste only as a last resort. Disposal, rather than storage, enhances the protection 

of workers and the public. Licensees also may find it more economical to dispose of radioactive 

waste than to store it on site because as the available capacity decreases, the cost of disposal 

of radioactive waste may continue to increase. Other than DIS, LLW should be stored only 

when disposal capacity is unavailable and for no longer than necessary. NRC IN 90-09, 

“Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials 

Licensees,” dated February 5, 1990, provides guidance to licensees for requesting an 

amendment to authorize extended interim storage of LLW. NRC RIS 2008-12, “Considerations 

for Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials 

Licensees,” updated this information. In addition, the NRC issued RIS 2011-09, “Available 

Resources Associated with Extended Storage of Low-Level Radioactive Waste” dated 

August 16, 2011, which refers to other helpful guidance documents.

Response from Applicant:

State that: “We will use the model waste procedures published in Appendix R in NUREG-1556, 

Volume 7, Revision 1, ‘Program-Specific Guidance about Academic, Research and 

Development, and Other Licenses of Limited Scope.’”

OR

If the applicant wishes to use only selected model procedures, state that: “We will use the 

(specify either (1) decay-In-storage, or (2) disposal of liquids into sanitary sewerage) model 

waste procedures that are published in Appendix Q in NUREG-1556, Volume 7, Revision 1, 

‘Program-Specific Guidance about Academic, Research and Development, and Other Licenses 

of Limited Scope.’”
74

AND

If access to a radioactive waste burial site is unavailable, the applicant should request 

authorization for extended interim storage of waste. Applicant should use the references listed 

below for guidance and submit the required information with the application.

Note: Applicants do not need to provide information to the NRC if they plan to dispose of LLW 

by transfer to an authorized recipient or to dispose of liquid scintillation media or animals 

containing low levels of H-3 or C-14 as authorized by 10 CFR 20.2005.

Alternative responses will be reviewed using the criteria listed above.

References:

• Information Notice 94-23, “Guidance to Hazardous, Radioactive, and Mixed Waste 

Generators on the Elements of a Minimization Program,” March 1994.

• Information Notice 94-07, “Solubility Criteria for Liquid Effluent Releases to Sanitary 

Sewerage under the Revised 10 CFR 20,” January 1994.

• Information Notice 84-94, “Reconcentration of Radionuclides Involving Discharges into 

Sanitary Sewerage Systems Permitted Under 10 CFR 20.303 (now 10 CFR 20.2003),” 

December 1984.

• Information Notice 90-09, “Extended Interim Storage of Low-Level Radioactive Waste by 

Fuel Cycle and Materials Licensees,” February 1990.

• Regulatory Issue Summary 2008-12, “Considerations for Extended Interim Storage of 

Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees,” May 2008.

• Regulatory Issue Summary 2011-09, “Available Resources Associated with Extended 

Storage of Low-Level Radioactive Waste,” August 2011.

• Policy and Guidance Directive PG 8-10, “Disposal of Incinerator Ash as Ordinary 

Waste,” January 1997, ADAMS Accession Nos. ML003744979 and ML003752866 and 

Addendum, ADAMS Accession Nos. ML003744984 and ML003744988.

• NRC Regulatory Issue Summary 2004-17, “Revised Decay-in-Storage Provisions for the

Storage of Radioactive Waste Containing Byproduct Material,” Revision 1, 

September 2005.

The next two items on NRC Form 313 should be completed on the form itself.

8.12 Item 12: License Fees

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

the fee enclosed with the application.
75

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

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

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

5642, extension 415-7554. The e-mail address for fees questions is Fees.Resource@nrc.gov.

8.13 Item 13: Certification

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

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

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

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

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

will return all unsigned applications for proper signature.

Notes:

• It is a criminal offense to make a willful false statement or representation on applications 

or correspondence (18 U.S.C. 1001).

• When the application references commitments, those items become binding and are part

of the license conditions and regulatory requirements

77

9. AMENDMENTS AND RENEWALS TO A LICENSE

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 

(10 CFR 2.109(a), 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 an 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 if many outdated 

documents are referenced or there have been significant changes in regulatory 

requirements, the NRC’s guidance, the licensee’s organization, or the licensee’s 

radiation protection program. Alternatively, describe clearly the exact nature of the 

changes, additions, and deletions.

9.1 Timely Notification of Transfer of Control

Regulation: 10 CFR 30.34(b)

Criteria: Licensees must provide full information and obtain the NRC’s prior, written consent

before transferring control of the license, or, as some licensees call it, “change of ownership” 

and/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 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.
78

• Public health and safety are not compromised by the use of such materials.

Response from Applicant: No response is required from an applicant for a new license. 

However, current licensees should refer to NUREG-1556, Volume 15, for more information 

about transfer of ownership.
79

10. APPLICATIONS FOR EXEMPTIONS

Regulations: 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11

Criteria: Licensees may request exemptions from 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.

Discussion: Various sections of the NRC’s regulations address requests for exemptions 

(e.g., 10 CFR 19.31, “Application for exemptions”; 10 CFR 20.2301, “Applications for 

exemptions”; 10 CFR 30.11, “Specific exemptions”). These regulations state that the NRC may 

grant an exemption, acting on its own initiative or on an application from an interested person.

Exemptions are not intended to revise regulations or apply to large classes of licensees and are 

generally limited to unique situations. Exemption requests must be accompanied by 

descriptions of the following:

• Exemption requested basis, and justification for the requested exemption.

• Proposed compensatory safety measures intended to provide a level of health and 

safety equivalent to the regulation for which the exemption is being requested.

• Alternative methods for complying with the regulation and an explanation of why 

compliance with the existing regulation is not feasible.

Until the NRC has granted an exemption in writing, licensees must comply with all applicable

regulations.

81

11. TERMINATION OF ACTIVITIES

Regulations: 10 CFR 30.34(b), 10 CFR 30.35(g), 10 CFR 30.36(d) and (k), 

10 CFR 30.36(j)(1), 10 CFR 30.51(d), (e) and (f)

Criteria: The licensee must do the following:

• Notify the NRC, in writing, within 60 days of the occurrence of any of the following:

– Expiration of its license.

– A decision to permanently cease licensed activities at the entire site.

– A decision to permanently cease licensed 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 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 leak 

tests of sealed sources; final status surveys for facilities using unsealed materials).

• Before a license is terminated, send the records required by 10 CFR 30.51(f) to the 

appropriate NRC regional office. If licensed activities are transferred or assigned in 

accordance with 10 CFR 30.34(b), transfer records important to decommissioning to the 

new licensee in accordance with 10 CFR 30.35(g).

Discussion: Typically, an ARDL facility termination request will meet the above criteria if the 

licensee performs the following steps:

• Disposes of or transfers all licensed materials to an NRC or Agreement State licensee 

authorized to possess the materials and devices as described in Section 8.11, “Waste 

Management.”

• Submits results of a final status survey of the facility, demonstrating that the facility 

meets Subpart E, “Radiological Criteria for License Termination,” to 10 CFR Part 20.

Most ARDL licenses should be able to use the methods found in Appendix B, “Simple 

Approaches for Conducting Final Radiological Surveys,” of NUREG-1757, “Consolidated 

Decommissioning Guidance,” Volume 2, “Characterization, Survey and Determination of 

Radiological Criteria.” If the simplified methods cannot be used, other guidance in 
82

NUREG-1757 may be applicable, as well as guidance in NUREG-1575, “Multi-Agency 

Radiation Survey and Site Investigation Manual (MARSSIM).”

• Submits copies of applicable decommissioning records as described in Section 8.5.2 

“Financial Assurance and Recordkeeping for Decommissioning.” Typically, these

include transfer records of spills that may have resulted in residual contamination, 

drawings or diagrams of facilities where radioactive materials were used or stored, the

list of designated restricted areas and areas where remediation may be needed, transfer 

records and final leak test records. See Section 8.5.2 for additional recordkeeping 

requirements if leaking sealed sources or other incidents that involve the spreading of 

contamination have occurred.

• Submits copies records of all applicable waste disposals (on-site burials, sewer disposal, 

incineration, and specific wastes) and records of results of surveys (measurements and 

calculations) of effluent releases.

• Submits a completed NRC Form 314 and a copy of the applicable decommissioning 

records to the appropriate NRC regional office.

Response from Applicant: The applicant is not required to submit a response to the NRC 

during the initial application. The licensee’s obligations in this matter begin when the license 

expires or at the time the licensee ceases operations, whichever is earlier. These obligations 

are to undertake the necessary decommissioning activities, to submit NRC Form 314 or

equivalent information, and to perform any other actions summarized in “Criteria” above.

References: 

• NRC Form 314 is available at http://www.nrc.gov/reading-rm/doc-collections/forms. 

• NUREG-1757, “Consolidated Decommissioning Guidance.” 

• NUREG-1575, “Multi-Agency Radiation Survey and Site Investigation Manual 

(MARSSIM).” 
APPENDIX A

LIST OF DOCUMENTS CONSIDERED IN DEVELOPMENT 

OF THIS NUREG

A-1

List of Documents Considered in Development of this NUREG

This document incorporates and updates the guidance previously found in the Regulatory 

Guides (RG) 10.2 and 10.7. In addition, it references other RGs, Policy and Guidance 

Directives (P&GD), Information Notices (IN), Inspection Procedure (IP), and other guidance 

documents used in its preparation. The guidance incorporated and referenced is listed in Table

A.1. Documents marked with an asterisk are superseded by this NUREG.

Table A.1 List of Documents Considered in the Preparation of this Report 

Document 

Identification

Title Date

ANSI N13.1 Sampling and Monitoring Releases of Airborne Radioactive 

Substances from the Stacks and Ducts of Nuclear Facilities

2011

ANSI N42.18 Specification and Performance of On-site Instrumentation for 

Continuously Monitoring Radioactive Effluents

1991

ANSI N323A Radiation Protection Instrumentation Test and Calibration 1997

Enforcement 

Policy, 

Enforcement 

Guidance

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

– Enforcement Policy at http://www.nrc.gov/aboutnrc/regulatory/enforcement/enforce-pol.html

– Enforcement guidance (and Enforcement Manual) at 

http://www.nrc.gov/aboutnrc/regulatory/enforcement/guidance.html

Federal 

Register 63 FR 

64132

Federal 

Register 64 FR 

68395

Federal 

Register 65 FR 

37186

Decommissioning Guidance

Supplemental Information on the Implementation of the Final 

Rule on Radiological Criteria for License Termination, 63 FR 

64132 (November 18, 1998) (building surfaces)

Supplemental Information on the Implementation of the Final 

Rule on Radiological Criteria for License Termination, 64 FR 

68395 (December 7, 1999) (soils)

Use of Screening Values to Demonstrate Compliance with the 

Final Rule on Radiological Criteria for License Termination, 65 

FR 37186 (June 13, 2000)

11/18/98

12/7/99

6/13/00

IN 84-94 Reconcentration of Radionuclides Involving Discharges into 

Sanitary Sewerage Systems Permitted under 10 CFR 20.303 

(now 10 CFR 20.2003)

12/21/84

IN 89-25, 

Revision 1

Unauthorized Transfer of Ownership or Control of Licensed 

Activities

12/94
A-2

Document 

Identification

Title Date

IN 90-09 Extended Interim Storage of Low-Level Radioactive Waste by 

Fuel Cycle and Materials Licensees

Updated by:

Regulatory Issue Summary (RIS) 2008-12, Considerations for

Extended Interim Storage of Low-Level Radioactive Waste by

Fuel Cycle and Materials Licensees

and 

RIS 2011-09, Available Resources Associated with Extended 

Storage of Low-Level Radioactive Waste, which refers to other 

helpful guidance documents

2/5/90

5/08

8/11

IN 94-07 Solubility Criteria for Liquid Effluent Releases to Sanitary 

Sewerage under the Revised 10 CFR 20

1/28/94

IN 94-23 Guidance to Hazardous, Radioactive, and Mixed Waste 

Generators on the Elements of a Waste Minimization Program

3/25/94

IN 96-28 Suggested Guidance Relating to Development and 

Implementation of Corrective Action

5/1/96

IN 97-30 Control of Licensed Material during Reorganizations, 

Employee-Management Disagreements, and Financial Crises

6/3/97

IN 99-033 Management of Wastes Contaminated with Radioactive Materials 12/21/99

IN 00-16 Potential Hazards caused by Volatilization of Radionuclides 10/5/00

IN 01-01 The Importance of Accurate Inventory Controls To Prevent the

Unauthorized Possession of Radioactive Material

3/26/01

IN 03-12 Problems Involved In Monitoring Dose to the Hands Resulting 

from the Handling of Radiopharmaceuticals

8/22/03

IN 09-07 Withholding of Proprietary Information from Public Disclosure 3/30/09

IN 09-30 Findings from the NRC Initiative To Assess Materials Licensees’ 

Compliance with the NRC Decommissioning Requirements

11/6/09

IP 87103 Inspection of Material Licensees Involved in an Incident or 

Bankruptcy Filing

11/3/00

IP 87126 Industrial/Academic/Research Programs 9/28/05

NUREG-1400 Air Sampling in the Workplace 9/93

NUREG-1516 Management of Radioactive Material Safety Programs at Medical 

Facilities

4/97

NUREG-1549 Decision Methods for Dose Assessment To Comply with 

Radiological Criteria for License Termination

7/98

NUREG-1556, 

Vol. 15

Consolidated Guidance about Materials Licenses: Guidance 

about Changes of Control and about Bankruptcy Involving 

Byproduct, Source, or Special Nuclear Materials Licenses

11/00
A-3

Document 

Identification

Title Date

NUREG-1757 Consolidated Decommissioning Guidance,

– Vol. 1, “Decommissioning Process for Materials Licensees”

(Revision 2), September 2006

– Vol. 2, “Characterization, Survey, and Determination of 

Radiological Criteria” (Revision 1), September 2006

– Vol. 3, “Financial Assurance, Recordkeeping, and Timeliness” 

Revision 1, February 2012

9/06

9/06

2/12

NUREG/

CR-4884

Interpretation of Bioassay Measurements 7/87

NUREG/

CR–5512, 

Vol. 3

Residual Radioactive Contamination from Decommissioning, 

Parameter Analysis

8/99

P&GD,

PG 8-10

Disposal of Incinerator Ash as Ordinary Waste

Policy and Guidance Directive PG 8-10, Disposal of Incinerator 

Ash as Ordinary Waste, dated January 1997, publicly available in 

the NRC’s Agencywide Documents Access and Management 

System (ADAMS) at Accession No. ;ML003744979

– Addendum to Draft PG 8-10, dated March 18, 1996, is publicly 

available in ADAMS at Accession No. ML003744984

– Generic Dose Assessment for Disposal of Incinerator Ash in a 

Landfill, September 1994, publicly available in ADAMS at 

Accession No. ML003752866

Technical Justification Addendum for PG 8-10, “Generic Dose 

Assessment for Disposal in a Landfill of Incinerator Ash 

Containing: S-35, Ca-45, Fe-59, P-32, and Tc-99m, using

RESRAD and NUREG-1500 Methodology,” March 8, 1996;

publicly available in ADAMS at Accession No. ML003744988

1/97

NCRP 

Commentary 

No. 3

Screening Techniques for Determining Compliance with 

Environmental Standards

1989/

Addendum

(1989)

NCRP Report 

No. 48

Radiation Protection for Medical and Allied Health Personnel 1976

NCRP Report 

No. 127

Operational Radiation Safety Program 1998

NCRP Report 

No. 105

Radiation Protection for Medical and Allied Health Personnel 1989

NCRP Report 

No. 114

Maintaining Radiation Protection Records 1992
A-4

Document 

Identification

Title Date

NCRP Report 

No. 157

Radiation Protection in Educational Institutions 2007

RG 4.20, 

Revision 1

Superseded by Regulatory Guide 4-20, Revision 1 “Constraint on 

Releases of Airborne Radioactive Materials to the Environment 

for Licensees Other than Power Reactors,” April 2012

4/12

RG 8.7, 

Revision 2

RG 8.7 Revision 2, Instructions for Recording and Reporting 

Occupational Radiation Exposure Data, November 2005 

11/05

RG 8.9 Acceptable Concepts, Models, Equations, and Assumptions for a 

Bioassay Program

7/1/93

RG 8.20 and 

DG-8050

Regulatory guide 8.20, Revision 1, “Applications of Bioassay for 

I-125 and I-131,” September 1979

DG-8050, “Applications of Bioassay for I-125 And I-131”

(ML102800439) September 2011 is also available on the NRC 

public web, Document Collections and in ADAMS

RG 8.25, 

Revision 1

Air Sampling in the Workplace 6/92

RG 8.32 Criteria for Establishing a Tritium Bioassay Program 7/98

RG 8.34 Monitoring Criteria and Methods to Calculate Occupational 

Radiation Doses

7/92

RG 8.37 ALARA Levels for Effluents from Materials Facilities 7/93

RIS-05-031 Control Of Security-Related Sensitive Unclassified NonSafeguards Information Handled By Individuals, Firms, And 

Entities Subject To NRC Regulation Of The Use Of Source, 

Byproduct, And Special Nuclear Material

12/22/05

RIS-07-004 Personally Identifiable Information Submitted to the U.S. Nuclear 

Regulatory Commission

3/9/07

RIS-08-012 Considerations for Extended Interim Storage Of Low-Level 

Radioactive Waste By Fuel Cycle And Materials Licensees

5/9/08

RIS-11-009 Available Resources Associated With Extended Storage Of LowLevel Radioactive Waste8/16/11

SP-96-022 All Agreement States Letter 6/92

“Air Sampling Instruments,” American Conference of 

Governmental Industrial Hygienists, 9th edition

2001

Handbook of Health Physics and Radiological Health, third 

edition, edited by Schlien, Slaback and Birky

1998
APPENDIX B

U.S. NUCLEAR REGULATORY COMMISSION FORM 313

B-1

United States Nuclear Regulatory Commission Form 313

Please use the most current version of this form, which may be found at: 

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

APPENDIX C

SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED 

IN ITEMS 5 THROUGH 11 OF NRC FORM 313

C-1

The table below is designed to help applicants develop their applications. In some instances, it 

is acceptable to simply indicate, by checking the box in the third column (Yes), that the applicant 

commits to adopting the model procedures referenced. If the third column contains an 

asterisk (✴), the licensee is expected to describe its program or submit its procedures for the 

particular item. In this instance, the applicant is requested to check the box in the fourth column 

indicating that the described program or procedures are attached to the application (NRC Form

313). If the third column contains an “N/A,” the licensee is not required to describe or submit its 

programs and procedures during the licensing phase. However, these program areas may be 

reviewed during an inspection.
C-2

The table below also may be used as a License Reviewer Checklist for applications for ARDL

licenses.

Item 

No.

Suggested Response Yes Description 

Attached

5. RADIOACTIVE MATERIAL

Unsealed or Sealed Sources

• For unsealed materials:

– Provide element name with mass number, chemical and/or 

physical form, and maximum requested possession limit.

– For potentially volatile materials (e.g., I-125, I-131, H-3), specify 

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

• For sealed materials:

– Identify each Radionuclide (element name and mass number) 

that will be used in each source.

– Provide the manufacturer’s (distributor’s) name and model 

number for each sealed source and device requested.

– Confirm that each sealed source, device, and source/device 

combination is registered as an approved sealed source or 

device by NRC or an Agreement State.

– Provide the activity per source and maximum activity in each 

device, and the maximum total number of sources and devices

• Provide an Emergency Plan (if required).

✴

✴

✴

✴

✴

✴

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

Financial Assurance and Recordkeeping for 

Decommissioning

If FA or a DFP is required, submit the required documents as 

described in NUREG-1757, Volume 3. 

Records important to decommissioning and written materials 

documenting compliance with other financial assurance 

requirements will be examined during inspection.

✴ [ ]
C-3

Item 

No.

Suggested Response Yes Description 

Attached

6. PURPOSE FOR WHICH LICENSED MATERIAL WILL BE USED

List the specific use or purpose of each radionuclide.

– Provide a description of uses in animals, if applicable

– Provide a description of tracer or field studies, if applicable

✴

✴

✴

[ ]

[ ]

[ ]

7. INDIVIDUALS RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING AND EXPERIENCE

Radiation Safety Officer (RSO)

• Provide the name of the proposed RSO and information 

demonstrating that the proposed RSO is qualified by training 

and experience. Information should include, as a minimum:

− Formal training or education in radiation safety (topics 

covered, duration of training, when training was received, 

identity and location of training provider ()(note: a course 

outline may be provided) 

− Experience using licensed materials (types, forms, quantities 

handled, activities performed, duration of experience)

− Experience performing the duties of an RSO (activities, 

duration of experience, scope of program)

✴ [ ]

Authorized Users (AUs) (persons who will use or supervise 

the use of licensed materials)

• Provide the name of each proposed AU, with the types and 

quantities of licensed material to be used. Also provide 

information demonstrating that each proposed AU is qualified 

by training and experience to use the requested licensed 

materials.

• Information should include, as a minimum:

– Formal training or education in radiation safety (topics 

covered, duration of training, when training was received, 

identity and location of training provider) (note: a course 

outline may be provided) 

– Experience using licensed materials (types, forms, quantities 

handled, activities performed, duration of experience)

✴ [ ]
C-4

Item 

No.

Suggested Response Yes Description 

Attached

8. TRAINING FOR INDIVIDUALS WORKING IN OR 

FREQUENTING RESTRICTED AREAS (Occupationally 

Exposed Individuals and Ancillary Personnel)

Submit a description of the radiation safety training program, 

including topics covered, groups of workers, assessment of 

training, qualifications of instructors, and the method and 

frequency of training.

✴ [ ]

9. FACILITIES AND EQUIPMENT

Describe the facilities and equipment that will be available at each 

location where radioactive material will be used (see Appendix H

for topics to consider). 

- Include the area(s) assigned for the receipt, storage, preparation 

and measurement of radioactive materials, use, and waste 

storage and handling. 

- Submit a diagram showing the locations of shielding, the 

proximity of radiation sources to unrestricted areas, and other 

items related to radiation safety. 

- When applicable to facilities where radioactive materials may 

become airborne, the diagrams should contain schematic 

descriptions of the ventilation systems, with pertinent airflow 

rates, pressures, filtration equipment, and monitoring systems. 

- Diagrams should be drawn to a specified scale, or dimensions 

should be indicated. 

- For facilities where it is anticipated that more than one laboratory 

or room may be used, a generic laboratory or room diagram may 

be submitted. 

Describe how facility design and procedures for operation will 

minimize contamination of the facility and the environment, 

facilitate eventual decommissioning, and minimize the generation 

of radioactive waste.

✴

✴

[ ]

[ ]

10. RADIATION SAFETY PROGRAM

Audit Program

The applicant is not required to, and should not, submit its audit 

program to the NRC for review during the licensing phase; 

however, the NRC will examine records and written materials 

documenting compliance during inspection.

N/A N/A
C-5

Item 

No.

Suggested Response Yes Description 

Attached

10. RADIATION SAFETY PROGRAM (Cont’d)

Radiation Monitoring Instruments

Describe the instrumentation that will be used to perform required 

surveys 

AND

State that: “We will use instruments that meet the radiation 

monitoring instrument specifications published in Appendix J in 

NUREG-1556, Volume 7, Revision 1, ‘Program-Specific Guidance 

about Academic, Research and Development, and Other Licenses 

of Limited Scope,’. We reserve the right to upgrade our survey 

instruments as necessary.”

Instrument Calibration

State that instruments will be calibrated before first use, at least 

annually thereafter, and after any repair, by a vendor that the NRC 

or an Agreement State has licensed to perform instrument 

calibration.

OR

State that: “We will implement the model survey meter calibration 

program published in Appendix J in NUREG-1556, Volume 7,

Revision 1 ‘Program-Specific Guidance about Academic, 

Research and Development, and Other Licenses of Limited 

Scope.’ ”

OR

Submit equivalent procedures for instrument calibrations. 

✴

[ ]

[ ]

[ ]

✴

[ ]

 [ ]
C-6

Item 

No.

Suggested Response Yes Description 

Attached

Material Receipt and Accountability

• State that: “We will develop, implement, and maintain 

procedures for ensuring accountability of licensed materials at 

all times.”

AND

State that: “Physical inventories will be conducted at intervals not 

to exceed 6 months, to account for all sealed sources and devices 

received and possessed under the license. Records of inventory 

shall be maintained for a period of 5 years from the date of each 

inventory, and shall include the radionuclides, quantities, 

manufacturer’s name and model numbers, and the date of the 

inventory.”

[ ]

[ ]

10. RADIATION SAFETY PROGRAM (Cont’d)

Occupational Dose

State that: “We have done a prospective evaluation and 

determined that unmonitored individuals are not likely to receive, in 

1 year, a radiation dose in excess of 10 percent of the allowable 

limits in 10 CFR Part 20,” or “We will monitor individuals in 

accordance with the criteria in Section 8.10.4 entitled ‘Radiation 

Safety Program–Occupational Dose’ in NUREG-1556, Volume 7,

Revision 1, ‘Consolidated Guidance about Materials Licenses: 

Program-Specific Guidance about Academic, Research and 

Development and Other Licenses of Limited Scope.’”

[ ]

Public Dose

No response is required from the applicant in a license application

but records and written materials documenting compliance will be 

examined during inspection.

N/A N/A
C-7

Item 

No.

Suggested Response Yes Description 

Attached

Safe Use of Radionuclides and Emergency Procedures

Provide your procedures for safe use of radionuclides, security of 

materials and emergencies. 

AND

If you want the option to make changes to the procedures, state 

that: “Procedures may be revised only if (1) the changes are 

reviewed and approved by the licensee management and the RSO 

in writing; (2) the licensee staff is provided training in the revised 

procedures before implementation; (3) the licensee management 

and the RSO review and approve the changes listed in (1) and (2) 

in writing.”

OR

State that: “We will adopt the procedures for the safe use of 

radionuclides, security and emergencies as published in 

Appendix M in NUREG-1556, Volume 7, Revision 1, ‘ProgramSpecific Guidance about Academic, Research and Development, 

and Other Licenses of Limited Scope.’”

OR

State that: “We will develop, implement, and maintain procedures 

for safe use, security and emergencies.”

Emergency Response Plan

If an emergency response plan is needed, submit it as a separate 

part of the application.

✴

[ ]

[ ]

[ ]

✴

[ ]

[ ]
C-8

Item 

No.

Suggested Response Yes Description 

Attached

10. RADIATION SAFETY PROGRAM (Cont’d)

Surveys

State that: “We will survey our facility and maintain contamination 

levels in accordance with the survey frequencies and 

contamination levels published in Appendix N in NUREG-1556, 

Volume 7, Revision 1, ‘Program-Specific Guidance about 

Academic, Research and Development, and Other Licenses of 

Limited Scope.’” 

Leak Testing

Frequency

State that: “Leak tests will be performed at the intervals approved 

by the NRC or an Agreement State and specified in the SSD 

registration certificate.”

AND

Analysis

State that: “Leak tests will be performed by an organization 

authorized by the NRC or an Agreement State to provide leak 

testing services to other licensees or by using a leak test kit 

supplied by an organization that the NRC or an Agreement State 

has authorized to provide leak test kits to other licensees and 

according to the sealed source or plated foil manufacturer’s 

(distributor’s) and kit supplier’s instructions.”

[ ]

[ ]

[ ]

OR

State that: “As an alternative, we will implement the model leak 

test program published in Appendix O in NUREG-1556, Volume 7,

Revision 1 ‘Consolidated Guidance about Materials Licenses: 

Program-Specific Guidance about Academic, Research and 

Development, and Other Licensees of Limited Scope.’”

OR

Alternate survey and leak testing procedures are attached.

[ ]

✴ [ ]
C-9

Item 

No.

Suggested Response Yes Description 

Attached

Transportation

No response is needed from applicants during the licensing phase 

but records and written materials documenting compliance will be 

examined during inspection.

N/A N/A

10. RADIATION SAFETY PROGRAM (Cont’d)

Security Program for Category 1 and Category 2 Materials

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.

N/A N/A

11. WASTE MANAGEMENT

State that: “We will use the model waste procedures published in 

Appendix Q in NUREG-1556, Volume 7, Revision 1, ‘ProgramSpecific Guidance about Academic, Research and Development, 

and Other Licenses of Limited Scope.’”

OR

Submit equivalent procedures for waste management.

If applicable

Submit waste disposal procedures for any method not covered in 

Appendix Q.

If access to a radioactive waste burial site is unavailable, the 

applicant should submit procedures and request authorization for 

extended interim storage of waste. 

[ ]

✴

✴

✴

[ ]

[ ]

[ ]

APPENDIX D

ELECTRON CAPTURE DETECTORS AND X-RAY FLUORESCENCE 

ANALYZER APPLICATIONS

D-1

The U.S. Nuclear Regulatory Commission (NRC) has designed this Appendix to assist the 

applicant who needs to obtain a license only for a small source or device. Typical items include 

an electron capture detector (ECD), such as used in a gas chromatograph (GC) or chemical 

agent detection or monitoring instrument, as well as small sealed sources used in an X-ray

fluorescence analyzer (XRF). This appendix also may be used as guidance for completing a 

license application that may be for these sources or devices as well as other requested 

radionuclide and proposed uses.

Regulations

Licensees are subject to all applicable provisions of the regulations in 10 CFR) Parts 20, 21, 30, 

71, 170 as they pertain to ECDs and XRFs.

This NUREG has already provided information for completing Items 1 through 4 of the 

application.

Additional information for Item 3 is requested below.

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 where licensed material will be used or stored. A post office box address is not 

acceptable. In addition, state whether ECD/XRFs will be used at temporary jobsites.

Item 5: Material to Be Possessed

(1) Provide the radionuclide(s) that each ECD/XRF will use.

(2) Provide the manufacturer and model number of the detector cell, foil source, plated 

source, or sealed source that each ECD/XRF will use.

(3) Specify the quantity (activity) of radioactive material that will be in each foil source, 

plated source, or other sealed source. Provide the number of sources of each foil 

source, plated source, or sealed source that will be possessed, if known. If the total 

number for each type of source is unknown, provide an anticipated total.

Note: ECDs that contain titanium tritide foils or scandium tritide foils require operating 

temperature control mechanisms and venting to the outside. Provide information on operating 

temperature controls and venting information with the application, if the application requests 

these types of foils. 

Item 6: Purpose for Which Licensed Material Will Be Used

Specify the purpose for which each ECD/XRF will be used.

Note: For use of portable ECDs and XRFs, refer to NUREG-1556, Volume 1, for additional 

guidance on portable devices containing licensed material.
D-2

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

Experience–Radiation Safety Officer

Provide the name of the person(s) who will be responsible for the ECDs/ XRFs. That person(s) 

will be specifically named on the license.

If the applicant does not propose ECD or XRF repair or maintenance, then no specific training 

and experience in using and handling radioactive materials is necessary for individuals who will 

use the device(s) or supervise their use. No special training or experience is needed to perform 

leak tests using a leak-test kit or to clean detector cells used in ECD devices, provided the 

source or foil is not removed from the detector cell.

If the applicant proposes to perform any operations that involve removal of sources containing 

radioactive material from the device or maintenance and repair of a device that involves the 

source, then they must ensure a “responsible individual” performs these operations. The 

responsible individual shall have received instruction and training in the principles and practices 

of radiation safety, the use of radiation detection instruments, and the performance of these 

operations. Such training may normally be accomplished in 1 or 2 days. In the application, 

provide the following information:

• Name of each responsible individual who will perform the operations

• Outline of the instruction and training each responsible individual has received in the 

principles and practices of radiation safety, the use of radiation detection instruments, 

and the operations that will be performed, including actual practice in performing the 

operations. Specify the amount of time spent on each topic in the training.

Item 8: Training Provided to Other Users

Persons who will only use an ECD or XRF under the supervision of the responsible individual 

named in Item 7 need no special training and their names do not need to be submitted. These 

supervised individuals should not be permitted to perform any maintenance or repair operations. 

Only responsible individuals specifically named in Item 7 shall perform such operations.

Item 9: Facilities and Equipment

10 CFR 30.33(a)(2) states that an application will be approved if the applicant’s proposed 

equipment and facilities are adequate to protect health and to minimize danger to life or 

property. As stated in 10 CFR 20.1801 and 10 CFR 20.1802, licensed material stored in an 

unrestricted area must be secured from unauthorized removal, and licensed materials in an 

unrestricted area and not in storage must be under the constant surveillance and immediate 

control of the licensee.
D-3

The room, laboratory, or storage area where the device is located should be (1) accessible only 

to persons authorized to use the device and (2) locked when an authorized person is not 

physically present. The application should state that the laboratory or area will be locked or 

secured when an authorized person is not present. The room, laboratory, or storage area 

cannot be considered a restricted area if it is accessible to unauthorized persons.

Item 10: Radiation Safety Program

10.1 Audit Program

Licensees must review the content and implementation of their radiation protection programs 

annually, to ensure compliance with NRC regulations and with the terms and conditions of the 

license. Appendix I contains a suggested audit program that is acceptable to the NRC. All 

areas indicated in Appendix I may not be applicable to every licensee and may not need to be 

addressed during each audit.

10.2 Radiation Detection Instruments

A survey meter for routine uses of ECD/XRF is not required.

If maintenance and repair operations are proposed as described in Item 7, and the operations 

involve the sealed source, provide information about what surveys will be performed, what type 

of survey meter will be used for conducting surveys, the range of the survey instrument, and 

calibration information, including frequency of calibration. It is not necessary to specify the 

manufacturer and model number of the survey meter. For more information on survey meters, 

see “Radiation Safety Program–Instruments,” in Section 8.10.2 and Appendix J.

10.3 Material Receipt and Accountability

Licensees are required to maintain records of receipt, transfer, and disposal of licensed 

material. Loss, theft, or misplacement of licensed material can occur; therefore, control and 

accountability of ECDs or XRFs must be ensured. License conditions require licensees that use 

or possess sealed sources to perform inventories of sealed sources every 6 months (see

sample license, condition no. 16). Some sealed sources may not be in use or rarely used and 

are placed into storage. In these cases, licensees should confirm at least every 6 months that 

these sealed sources have not been disturbed. If authorization is requested to use the devices 

at temporary jobsites, the licensee should develop procedures that address sign-out of devices 

for use in the field, control and security of the device in the field, and use of the device to ensure 

protection of members of the public.

10.4 Personnel Monitoring Equipment

Personnel monitoring devices are not required for the following:

• routine use and normal operation of ECDs/XRFs

• maintenance and repair operations described in Item 7, if the radiation source in the 

ECD/XRF is in a gaseous form or is nickel-63 (Ni-63)
D-4

If proposed uses of ECDs/XRFs include maintenance and repair operations described in Item 7, 

and these operations involve sealed sources other than in gaseous form, tritium [H-3], or Ni-63, 

an evaluation for personnel monitoring devices is required for persons performing these 

operations.

The application should indicate that maintenance and repair personnel will be provided with 

appropriate personnel dosimeters for use while performing service operations or a dose 

evaluation indicating that personnel will not be required to wear monitoring devices.

10.5 Leak Testing

The NRC requires testing to determine if there is any radioactive leakage from sealed or plated 

foil sources. Records of surveys and leak test results must be maintained.

When issued, a license will require leak tests of sealed and plated foil sources at intervals as 

approved by the NRC or an Agreement State and specified in the SSD registration certificate. 

The measurement of the leak test sample is a quantitative analysis that requires instrumentation 

used to analyze that the sample is capable of detecting 185 Bq (0.005 μCi) of radioactivity.

The NRC or an Agreement State may authorize manufacturers, consultants, and other 

organizations to perform the entire leak test sequence for other licensees or to provide leak test 

kits to licensees. In the latter case, the licensee is expected to take the leak test sample 

according to the sealed source or plated foil manufacturer’s (distributor’s) and the kit supplier’s 

instructions and return it to the kit supplier 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. Licensees also may be authorized to conduct the 

entire leak test sequence. For more information about leak testing sealed and plated foil 

sources, see “Radiation Safety Program–Surveys,” in the main body of this NUREG.

10.6 Maintenance and Repair

If authorization has been requested to perform maintenance and repair operations as stated in 

Item 7, then state in the application that the written procedures that the device manufacturer 

provided will be followed for each operation requested. If a procedure other than that provided 

by the device manufacturer will be followed, submit a proposed procedure for each operation 

requested.

10.7 Transportation

If the application requests authorization to use ECDs or XRFs at a temporary jobsite, the 

applicant must take into consideration DOT regulations, particularly blocking and bracing the 

device containing licensed material. The applicant is not required to submit transportation 

information with the application.

10.8 Minimization of Contamination

Regulations in 10 CFR 20.1406 require new license applicants to describe how facility design 

and procedures for operation will minimize, to the extent practicable, contamination of the facility 
D-5

and the environment; facilitate eventual decommissioning; and minimize, to the extent 

practicable, the generation of radioactive waste.

Item 11: Waste Management

Because of the nature of the licensed material contained in ECD or XRF devices, the usual 

disposal option is to transfer the licensed material to an authorized recipient. State in the 

application that disposal will be by transfer of the radioactive material to a licensee specifically 

authorized to possess it, or provide information for an alternate method of disposal for NRC 

review.

Authorized recipients are the original supplier of the device, a commercial firm that the NRC or 

an Agreement State has licensed to accept radioactive waste from other persons, or another 

specific licensee authorized to possess the licensed material. No one else is authorized to 

receive licensed material.

Suggested Format for Providing Information Requested in Items 1 through 4 of NRC 

Form 313

D.1 ITEM 1: ACTION TYPE

ACTION TYPE:

[ ] New

[ ] Amendment

[ ] Renewal

ADMINISTRATIVE REVIEW:

[ ] Current Guidance Used

[ ] References in Application Based On Current Regulations

[ ] All Attachments Referenced Included

[ ] Signature on Application

D.2 ITEM 2: LEGAL IDENTITY

NAME:

D.3 ITEMS 2 & 3: ADDRESS

STORAGE & LOCATION OF USE ADDRESS: MAILING ADDRESS:

Temporary Job Sites [ ] YES [ ] NO

D.4 ITEM 4: PERSON TO BE CONTACTED ABOUT THIS APPLICATION

CONTACT PERSON:

TELEPHONE NUMBER:

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

Form 313.
D-6

D.5 ITEMS 5 & 6: MATERIALS TO BE POSSESSED AND PROPOSED USES

Yes No Radionuclide Mfg and 

Model No.

Quantity

(activity per 

source, 

number of 

sources in 

device, and 

maximum 

number of 

sources)

Purpose of 

Use

Specify Other 

Uses Not 

Listed on SSD 

Certificate

Hydrogen-31 Manufacturer

name and 

model number

Measure 

physical 

properties of 

materials

[ ] Not 

applicable

[ ] Uses are:

Iron-55 Manufacturer

name and 

model number

Measure 

physical 

properties of 

materials

[ ] Not 

applicable

[ ] Uses are:

Cobalt-57 Manufacturer

name and 

model number

Measure 

physical 

properties of 

materials

[ ] Not 

applicable

[ ] Uses are:

Nickel-63 Manufacturer

name and 

model number

Measure 

physical 

properties of 

materials

[ ] Not 

applicable

[ ] Uses are:

Americium241Manufacturer

name and 

model number

Measure 

physical 

properties of 

materials

[ ] Not 

applicable

[ ] Uses are:

Other 

(specify)

1

 If titanium tritide foils or scandium tritide foils are requested, provide operating temperature control and venting

 information. (See “Note” in Item 5 of this appendix.)
D-7

D.6 ITEMS 7 THROUGH 11: TRAINING AND EXPERIENCE, FACILITIES AND 

EQUIPMENT, RADIATION SAFETY PROGRAM, AND WASTE DISPOSAL

Item 

No.

Title and Criteria Yes Description 

Attached

7 INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING EXPERIENCE

RSO

Name:

Before obtaining licensed materials, the proposed RSO will have 

successfully completed the training described in Appendix D, in 

NUREG-1556, Vol. 7.

AND

Before being named as the RSO, future RSOs will have successfully 

completed the training described in Appendix D, in NUREG-1556, 

Vol. 7.

[ ]

[ ]

8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING 

RESTRICTED AREAS

Individuals working under the supervision of a responsible person 

named in Item 7, above, are not required to have any specific 

radiation safety training before using an ECD/XRF.

N/A

9 FACILITIES AND EQUIPMENT

Describe the facilities where ECD/XRFs will be used and stored. 

Additional information on the use and storage of ECD/XRFs at a 

temporary jobsite also should be included in the response.

Submit 

description with 

application
D-8

Item 

No.

Title and Criteria Yes Description 

Attached

10 RADIATION SAFETY PROGRAM

Audit Program

The applicant is not required to, and should not, submit its audit 

program to the NRC for review during the licensing phase.

N/A

Survey Instruments

No survey instrument is required if proposed use does not involve

the removal of sources from the device or any maintenance and 

repair of a device that involves the source.

OR

If the applicant proposes to perform operations that involve removal 

of sources from the device or maintenance and repair of a device 

that involves the source, state that: “we will possess or have access 

to a radiation survey meter that meets the requirements in the 

procedures for performing removal or repair of the sources.”

[ ]

[ ]

Material Receipt and Accountability

Physical inventories will be conducted at intervals not to exceed 

6 months, to account for all sealed sources and devices received 

and possessed under the license.

[ ]

Occupational Dosimetry

No personnel monitoring is required if proposed use does not involve 

the removal of sources from the device or any maintenance and 

repair of a device that involves the source.

OR

If the applicant proposes to perform operations that involve the 

removal of sources from the device or maintenance and repair of a 

device that involves a source (other than in gaseous form, H-3 or 

Ni-63), state that: “we will maintain, for NRC inspection, 

documentation demonstrating that unmonitored individuals are not 

likely to receive a radiation dose in excess of 10 percent of the 

allowable limits in 10 CFR Part 20,” or “we will provide dosimetry 

processed and evaluated by an NVLAP-approved processor that is 

exchanged at a frequency recommended by the processor.”

[ ]

[ ]
D-9

Item 

No.

Title and Criteria Yes Description 

Attached

Public Dose

The applicant is not required to submit a response to the public dose 

section during the licensing phase. This matter will be examined 

during an inspection.

N/A

10 RADIATION SAFETY PROGRAM (Cont’d)

Leak Test

Leak tests will be performed at intervals specified in the SSD 

registration certificate. Leak tests will be performed by an 

organization that the NRC or an Agreement State has authorized to 

provide leak testing services for other licensees, or they will be 

performed using a leak test kit that an organization authorized by the

NRC or an Agreement State has supplied to provide leak test kits to 

other licensees.

[ ]

Maintenance

If authorization has been requested to perform the maintenance and 

repair operations described in Item 7, state in the application that the 

written procedures that the device manufacturer provided will be 

followed for each such operation requested.

OR

If a procedure will be followed other than that the device 

manufacturer provided, submit a proposed procedure for each 

operation

[ ]

[ ]

Transportation

The applicant is not required to submit its response to transportation 

during the licensing process; however, this issue will be reviewed 

during inspection.

N/A

Minimization of Contamination

The applicant is not required to submit a response to the 

minimization of contamination section if the applicant’s responses 

meet the criteria for the following sections: “Radiation Safety 

Program–Leak Tests,” “Facilities and Equipment,” and “Waste 

Management.”

N/A
D-10

Item 

No.

Title and Criteria Yes Description 

Attached

11 WASTE MANAGEMENT

ECDs/XRFs Disposal and Transfer

The applicant is not required to submit a response to waste 

management during the licensing process. The licensee should, 

however, develop, implement, and maintain ECD/XRF transfer and 

disposal procedures in its radiation safety program.

N/A
APPENDIX E

GUIDANCE FOR LABORATORY ANIMAL AND VETERINARY 

MEDICINE USES

E-1

This appendix provides additional information on the use of byproduct materials in laboratory 

animals, in animals used for research in the environment, and by veterinarians.

Use of Licensed Materials in Animals for Research 

Many animal studies are performed with radioactive materials used as tracers in pharmaceutical 

research, metabolism studies, and other areas of scientific research. Many tracer studies use 

low-energy beta-emitters such as tritium or carbon-14, but pharmaceutical studies may be 

performed with gamma-emitters such as technetium-99m, fluorine-18, and other radioactive 

materials typically found in nuclear medicine. In addition to the typical laboratory animals such 

as mice, rats, and rabbits, animal use may involve insects, fish, birds, or large animals such as 

dogs, pigs, or cows. Licensed materials typically are administered to animals by injection, but 

other methods may be used. The type, form, and quantity of licensed material used in the 

study, and the types of animals in which they will be used, will determine which radiation safety 

procedures will be implemented. If a researcher wants to use radioactive material as a tracer or 

as part of a field study involving the release of the animals into the environment, the researcher 

may be required to perform an assessment of the effect the byproduct material will have on the 

environment. See Section 8.6, “Purpose(s) for Which Licensed Material Will Be Used.”

Use of Licensed Materials in Veterinary Treatment for Diagnosis or Therapy 

The use of licensed materials in animals for diagnosis and therapy is similar in many ways to 

medical use of licensed materials in humans. The most common veterinary uses of licensed 

material in animals are the administration of iodine-131 for therapeutic treatment of cats, and 

the administration of technetium-99m for diagnostic studies in horses. Although 10 CFR Part 35 

establishes the requirements and provisions for the medical use of byproduct material for , 

humans, the regulations in Part 35 are not applicable to veterinary use of licensed materials.

However, many veterinary applicants use safety equipment and procedures similar to those

used in treating patients under Part 35 Also, many veterinarians obtain radioactive compounds, 

radiopharmaceuticals, or sealed sources for diagnosis and therapy of animals from the same 

suppliers as do medical facilities licensed under Part 35[NEW PARAGRAPH] The applicant 

should describe how licensed materials will be obtained, such as in unit doses from a 

radiopharmacy. The requirements for training veterinary staff, and the procedures for 

contamination control and waste disposal for diagnosis and therapy are the same as for 

laboratory use in research studies on animals. Note that veterinary treatment of animals must 

be performed under the direction of a licensed veterinarian in accordance with State regulations, 

so that the applicant should include at least one veterinarian in its list of proposed AUs. Most 

animals that veterinarians treat are pets that will be returned to their owners, and special care 

must be taken to ensure that doses to the owners, who are members of the public, will be 

ALARA. Therefore, the veterinary facility must also provide instructions to the pet owner on the 

care and handling of the animal when it is released.

Training for Staff using Radionuclides in Animals

Before allowing an individual to care for animals that are used in studies or treated with licensed 

material, the RSO or Authorized User (AU), must ensure that he or she has sufficient training 

and experience to, among other things, maintain doses ALARA, control contamination, and 
E-2

handle waste appropriately. AUs may be, for example, veterinarians, researchers, other 

laboratory staff, and animal handlers

Classroom training may be by traditional lecture, online or recorded presentations, self-study or 

other appropriate forms, and should cover the following subject areas:

• principles and practices of radiation protection

• radioactivity measurements, monitoring techniques, and using instruments

• mathematics and calculations basic to using and measuring radioactivity

• biological effects of radiation

Appropriate on-the-job-training should consist of:

• Observing authorized personnel perform licensed activities with animals, including 

administration of the radioactive material to the animal, using survey equipment, proper 

contamination control techniques, and proper methods for disposal of radioactive 

material.

• Performing licensed activities with animals under the supervision of, and in the physical 

presence of, an individual authorized to handle animals treated with licensed material or 

otherwise containing licensed material. It is recommended that an individual practice

new procedures without the use of radioactive materials prior to performing licensed 

activities. Activities should include the administration of radioactive material to an 

animal, use of survey equipment, proper contamination control techniques, and proper 

disposal of radioactive material.

• Training that is specific to the radionuclides (types, forms and quantities; radiations 

emitted; chemical composition) used under the license, the procedures that will be 

performed, the animals used, and the surveys and contamination control activities 

necessary for the materials used and procedures performed.

Contamination Control and Waste Handling

To minimize the spread of contamination, the animals administered licensed material should be 

housed in cages or stalls separate from other animals. The facilities, stalls, or cages shall be 

secured to prevent unauthorized access to the animals. Individuals caring for these animals 

should reduce the chance of personal contamination by wearing gloves, lab coat, eye 

protection, or other protective clothing as appropriate. Special care should be observed when 

cleaning the cage or stall that may contain radioactive material in the bedding, and waste 

(excreta) from the animal. Any radioactive material should be properly disposed of as described 

in Section 8.11, “Waste Management.”

Animals that have been treated with certain compounds may require special facilities. For 

example, carbon-14 labeled compounds used in animals may be eliminated as carbon dioxide 

in the animals’ breath, and require special facilities for controlling airborne contamination. 

Studies of fish with licensed materials may require separate water handling systems and testing

of water for contamination before release of the water. Special precautions also may be needed 

for handling of animals and performing surveys if alpha-emitting radionuclides are used.
E-3

Disposal of animals that contain radioactive material may require special procedures. Animal 

carcasses that contain less than 1.85 kBq (0.05 microcuries) of carbon-14 or hydrogen-3 per 

gram of animal tissue, averaged over the weight of the entire animal, may be disposed of by the 

same method as nonradioactive animal carcasses. Animal carcasses that contain byproduct 

material with a half-life of less than 120 days may be allowed to decay-in-storage (DIS). The 

DIS animal carcasses may be disposed as nonradioactive, if radiation surveys (performed with 

an appropriate radiation survey instrument, in a low background area and without any 

interposed shielding) of the carcasses at the end of the holding period indicate that radiation 

levels are indistinguishable from background (see Section 8.11, “Waste Management”). Animal

carcasses containing other long-lived radioactive materials must be disposed of as radioactive 

waste.

Release of Animals for unrestricted Use 

Any animal that has been injected with a radioactive compound or has had radioactive sources 

implanted cannot be released until the researcher or veterinarian ensures that the dose that 

members of the public will receive from the animal is within limits of 10 CFR 20.1301, “Dose 

limits for individual members of the public.” Regulations in 10 CFR 20.1301 require that the 

total effective dose equivalent to an individual member of the public from the licensed operation 

does not exceed 1 millisievert (mSv) (0.1 rem or 100 millirem (mrem)) in a year and that the 

dose in any unrestricted area from external sources does not exceed 0.02 mSv (0.002 rem or 

2 mrem) in any 1 hour. A member of the public is any individual except when that 

individual is receiving an occupational dose. Members of the public therefore include

bystanders, pet owners, family members, or other caretakers of the animal after the 

researcher or veterinarian has released it.

The most common example of a situation in which animals are treated with licensed materials

and then released, is the administration of iodine-131 (I-131) to cats for the treatment of 

hyperthyroidism. Therefore, this treatment will be used as an example for release of animals 

following administration of licensed material.

The NRC will authorize release of cats treated with I-131 when: 

• cats are held not less than 4 complete days (96 hours) after administration AND

• the dose rate is less than 1 mR/hr at 6 inches (0.25 mR/hr at 1 foot); AND

• written instructions are provided to the owners; AND

• the licensee can demonstrate that a member of the public would not receive a dose from 

the cat that would exceed 2 mrem in any one hour or 100 mrem in a year (the limits of 

10 CFR 20.1301). 

The licensee must ensure that the dose from a cat treated with I-131 to individual members of 

the public (including members of the family) does not exceed the 2 millirem in any 1 hour, and 

100 mrem annual public dose limit specified in 10 CFR 20.1301. The licensee should provide 

the owner with written instructions (to avoid confusion) to reduce the dose to members of the 
E-4

public. The instructions should provide a margin for dose reduction but should not be relied 

upon as the primary way of keeping the dose to members of the public below the 100 mrem 

public dose limit.

In applying the above criteria for release of cats, patient-specific information and radiation data

should also be considered. The dose rate of 0.25 mR/hr at 1 foot is a conservative release 

criteria. If the owner follows instructions to limit interaction with the cat for the first few days, it is 

unlikely that a person would receive a 100 mrem dose. The applicant must include criteria for 

release of cats treated with licensed materials from veterinary or laboratory activities in its 

application for review and approval, before implementation. The NRC may accept alternate 

proposed criteria for veterinary cat release if (1) the instructions pertaining to the extent and 

duration of contact permitted with the cat are easy for the owner to comply with, and (2) the 

potential dose would be well below 2 millirem in any 1 hour and 100 mrem in a year. Such 

proposals will be reviewed on a case-by-case basis. Additional consideration may be 

necessary when establishing the r date for release of a cat treated with I-131 to a home with 

small children. 

For cats, release criteria above 0.5 mR/hr at 1 foot are not recommended because it is unlikely 

that, if release criteria is less restrictive, doses to members of the public will be less than 2 

millirem in any one hour, and less than 100 millirem in a year. In addition, cats released at 

higher radiation levels also may contain enough radioactive material that I-131 contamination of 

the owner and home from saliva, urine, and feces may be of concern.

Instructions to Animal Caretaker upon Release

Once the veterinarian determines that the animal meets the dose criteria for release, 

instructions should be given to the animal’s caretaker. Written instructions should address, as a 

minimum. (1) waste handling, (2) contamination, and (3) human interaction with instructions for 

isolation of the animal. 

These instructions should be specific to the type of treatment given, such as permanent 

implants, or radioiodine for hyperthyroidism or thyroid carcinoma, and they may include 

additional information for individual situations. The instructions should not, however, interfere 

with or contradict the best medical judgment of the veterinarian. The instructions should include 

the name of a knowledgeable person to contact and that person’s telephone number, in case 

the caretaker has any questions. 

Although it is acceptable to dispose of nonradioactive animal excreta in a landfill, radioactive 

waste may not be disposed of in this way. For animals treated with radioactive materials,

instructions to caretakers should include storing animal excreta in a remote location for a 

designated period of time to allow the radioactive material to decay. Many solid waste disposal 

Criteria for release of cats and other animals treated with licensed materials from 

veterinary or laboratory activities must be included in your application for review and 

approval, before implementation. Regardless of the release level used, the licensee

should have records to document that the veterinary patient release criterion used for 

an individual veterinary patient will result in compliance with 10 CFR 20.1301.
E-5

facilities have installed radiation detectors to prevent the disposal of radioactive material at 

landfills. If the detectors indicate that there is radioactive material in the waste truck, the waste 

disposal facility staff or a contractor must search the truck and remove the radioactive material, 

which is a hazardous, costly, and time-consuming process. 

Items to consider including in the instructions are:

• the regulatory limits and the need to keep doses ALARA 

• the potential radiation fields surrounding the animal and potential dose with time at 

various distances 

• maintaining distance from people in public places and the home

• minimizing time in public places (e.g., walks on public sidewalk, parks, beaches, 

grooming salon)

• precautions to reduce the spread of radioactive contamination

• the handling and storage of animal excreta , and the duration of storage if held for decay

• the permitted extent and duration of contact by individuals with the animal, and handling 

of contaminated bedding and other objects with which the animal comes into contact.

• the length of time each of these precautions should be in effect
E-6

Sample Instructions to Caretakers of Animals Administered Radiopharmaceuticals or 

Other Unsealed Radionuclides

The animal has been treated with radioactive material (isotope) and still contains a low level of 

radioactivity. The present level of radioactivity is below the regulatory agency level necessary 

for isolating the animal from humans. Because some radioactivity will be present for the next 

few days, it is necessary that the following safety precautions be exercised for the next

 days:

1. Avoid public transportation; avoid staying in public accommodations (hotels). Transport 

your animal in its carrier as far from passengers as is reasonable and safe for the 

animal.

2. The animal should be kept inside or in his cage or stall following hospital discharge.

3. The animal should not be permitted to have prolonged contact with children under the 

age of 12 for days following hospital discharge. Close contact should be limited to 

less than ____ minutes per day.

4. Pregnant women should avoid ANY contact with the animal or its urine and feces for at 

least days after discharge.

5. Family members should not be permitted to sleep with the animal for days after 

discharge. They also should limit close contact with the animal (being within 1 meter or 

3 feet of the animal) for the next day(s) to no more than minutes a day. 

Preferably, contact with the animal should be kept to a distance of more than 1 meter or 

3 feet for this period.

6. Use a plastic litter pan liners and a scoopable litter (for cats).

7. Disposable gloves should be worn whenever handling animal waste, including changing 

the litter box for the next days after discharge.

8. Wash hands after contact with the animal or the litter.

9. Call to discuss any other radiation safety 

concerns.
E-7

Sample Instructions to Caretakers of Animals Implanted with Radioactive Sealed 

Sources

A small radioactive source has been placed (implanted) inside the animal. The source 

actually consists of many small metallic pellets or seeds, which are each about 1/4-inch to 

1/3-inch long, similar in size and shape to a grain of rice. 

The following precautions should be taken for days, to minimize exposure to radiation to 

humans from the source inside the animal:

• Stay at a distance of feet from .

• Avoid public transportation. 

• Transport your animal in its carrier as far away from passengers as is reasonable 

• Maintain separate sleeping arrangements, avoid staying in public accommodations 

(hotels)

• Minimize time that children and pregnant women are with the animal.

• Do not hold or cuddle pet.

• Examine any bandages that come into contact with the implant site for any pellets or 

seeds that may have come out of the implant site.

If a seed or pellet has fallen out, do the following:

• Do not handle it with fingers. Use something like a spoon or tweezers to place it in a 

jar or other container that can be closed with a lid.

• Place the container with the seed or pellet in a location away from people.

• Call to discuss disposal of the released seed 

or pellet and any other radiation safety concerns.

Contamination Control 

To minimize the spread of contamination, the animals administered licensed material should be 

housed in cages or stalls separate from other animals. The facilities, stalls, or cages should be 

secured to prevent unauthorized access to the animals. Individuals caring for these animals 

should reduce the chance of personal contamination by wearing gloves, lab coat, eye 

protection, or other protective clothing as appropriate.

Special care should be observed when cleaning a cage or stall that may contain radioactive 

material in the bedding, and waste (excreta) from the animal. Any radioactive material should 

be properly disposed of as described in Section 8.11, “Waste Management.”
E-8

The use of some compounds in animals may require special procedures, equipment or 

facilities. For example carbon-14 labeled compounds used in animals may be eliminated as 

carbon dioxide in the animals’ breath and the animals may need to be contained in a facility with 

special ventilation and air-handling capabilities. Studies of fish with licensed materials may 

require separate water handling and testing. Special precautions also may be needed for 

handling of animals and performing surveys if alpha-emitting radionuclides are used.

Waste Handling

Disposal of animal carcasses that contain radioactive material may require special procedures. 

Animal carcasses that contain less than 1.85 kBq (0.05 microcuries) of carbon-14 or hydrogen-3 

per gram of animal tissue, averaged over the weight of the entire animal, may be disposed of by 

the same method as nonradioactive animal carcasses. Animal carcasses that contain 

byproduct material with a half-life of less than 120 days may be allowed to decay-in-storage

(DIS). The DIS animal carcasses may be disposed of as nonradioactive, if radiation surveys 

(performed with an appropriate radiation survey instrument, in a low background area and 

without any interposed shielding) of the carcasses at the end of the holding period indicate that 

radiation levels are indistinguishable from background. Animal carcasses containing other 

long-lived radioactive materials must be disposed of as radioactive waste.

Disposal of contaminated items such as animal bedding, syringes, protective gloves, booties, 

and paper coverings may be by DIS if the licensed materials have half-lives of 120 days or less, 

or by transfer to a licensed waste broker for long-lived radioactive materials. Some wastes may 

be suitable for disposal to the sanitary sewer, such as animal excreta, which is readily 

dispersible biological material and could meet the criteria in 10 CFR 20.2003. See Section 8.11, 

“Waste Management,” and Appendix Q for more information on waste disposal. 
APPENDIX F

RADIATION SAFETY OFFICER DUTIES AND RESPONSIBILITIES

F-1

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

NRC and DOT regulations and the conditions of the license (see Figure 8.4). Typically, these 

duties and responsibilities include the following:

• Ensure that licensed material that the licensee possesses is limited to the types and 

quantities of byproduct material listed on the license.

• Maintain documentation demonstrating that the dose to individual members of the public 

does not exceed the limit specified in 10 CFR 20.1301.

• Ensure security of radioactive material.

• Post documents as required by 10 CFR Parts 19.11, “Posting of notice to workers,” and 

21.6, “Posting requirements.”

• Ensure that licensed material is transported in accordance with applicable NRC and 

DOT requirements.

• Ensure that radiation exposures are “ALARA.”

• Oversee all activities involving radioactive material, including monitoring and surveys of 

all areas in which radioactive material is used.

• Act as liaison with the NRC and other regulatory authorities.

• Provide necessary information on all aspects of radiation protection to personnel at all 

levels of responsibility, pursuant to 10 CFR Parts 19 and 20, and any other applicable 

regulations.

• Oversee proper delivery, receipt, and conduct of radiation surveys for all shipments of 

radioactive material arriving at or leaving from the institution, as well as packaging and 

labeling all radioactive material leaving the institution.

• Determine the need for personnel monitoring, distribute and collect personnel radiation 

monitoring devices, evaluate bioassays, monitor personnel radiation exposure and 

bioassay records for trends and high exposures, notify individuals and their supervisors 

of radiation exposures approaching the limits, and recommend appropriate remedial 

action.

• Conduct training programs and otherwise instruct personnel in the proper procedures for 

handling radioactive material before use, at periodic intervals (refresher training), and as 

required by changes in procedures, equipment, regulations, etc.

• Supervise and coordinate the radioactive waste disposal program, including effluent 

monitoring and recordkeeping on waste storage and disposal records.

• Oversee the storage of radioactive material not in current use, including waste.
F-2

• Perform or arrange for leak tests on all sealed sources and calibration of radiation 

survey instruments.

• Maintain an inventory of all radionuclides possessed under the license and limit the 

quantity to the amounts that the license authorizes.

• Immediately terminate any unsafe condition or activity found to be a threat to public 

health and safety or property.

• Supervise decontamination and recovery operations.

• Maintain other records not specifically designated above, for example, records of 

receipts, transfers, and surveys as required by 10 CFR 30.51, “Records,” and 

10 CFR Part 20, Subpart L, “Records.”

• Hold periodic meetings with, and provide reports to, licensee management.

• Ensure that all users are properly trained.

• Perform periodic audits of the radiation safety program to ensure that the licensee is 

complying with all applicable NRC regulations and the terms and conditions of the 

license (e.g., leak tests; inventories; use limited to trained, approved users), the content 

and implementation of the radiation safety program to achieve occupational doses and 

doses to members of the public that are ALARA in accordance with 10 CFR 20.1101 and 

required records are maintained.

• Ensure that the results of audits, identification of deficiencies, and recommendations for 

change are documented (and maintained for at least 3 years) and provided to 

management for review; ensure that prompt action is taken to correct deficiencies.

• Ensure that the audit results and corrective actions are communicated to all personnel 

who use licensed material.

• Ensure that all incidents, accidents, and personnel exposure to radiation in excess of 

ALARA or 10 CFR Part 20 limits are investigated and reported to the NRC and other 

appropriate authorities, if required, within the required time limits.

• Maintain understanding of and up-to-date copies of NRC regulations, the license, 

revised licensee procedures, and ensure that the license is amended whenever there 

are changes in licensed activities, responsible individuals, or information or 

commitments provided to NRC during the licensing process.
F-3

 

Model Delegation of Authority to RSO

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 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

RADIATION SAFETY TRAINING TOPICS

G-1

This appendix is intended only as a guide for developing a training program. Individuals 

working with radionuclides may not require training on every topic provided. For example, 

housekeeping staff may need to know only what symbols to look for, which waste cans to 

empty, or which areas to enter or avoid. Conversely, laboratory technicians may require 

detailed information on particular topics. As a result, instruction for some individuals may be 

provided through a simple hand-out, whereas others may require extensive training, including a 

written exam to assess retention of the topics presented.

Frequency of Training

A. Before assuming duties with, or in the vicinity of, radioactive materials.

B. Whenever there is a significant change in duties, regulations, or the terms of the license.

C. Annually (refresher training).

General Information

A. Radiation safety

1. radiation vs. contamination

2. internal vs. external exposure

3. biological effects of radiation

4. as low as is reasonably achievable (ALARA) concept

5. use of time, distance, and shielding to minimize exposure.

B. Regulatory requirements

1. RSO

2. material control and accountability

3. personnel dosimetry

4. radiation safety program audits

5. transfer and disposal

6. recordkeeping

7. surveys

8. postings

9. labeling of containers

10. handling and reporting of incidents or events

11. licensing and inspection by NRC

12. need for complete and accurate information

13. employee protection

14. deliberate misconduct

Licensee-Specific Program Elements

A. Authorized users and supervised users.

B. Ordering and receiving radionuclides.

C. Applicable regulations and license conditions.
G-2

D. Areas where radioactive material is used or stored.

E. Potential hazards associated with radioactive material in each area where the individuals 

will work.

F. Appropriate radiation safety procedures.

G. Licensee’s in-house work rules. (For instructions on laboratory safety and uses of 

radionuclides, see Section IV.)

H. Each individual’s obligation to report unsafe conditions to the RSO.

I. Appropriate response to spills, emergencies, or other unsafe conditions.

J. Worker’s right to be informed of occupational radiation exposure and bioassay results, if 

applicable.

K. Locations where the licensee has posted or made available: notices, copies of pertinent 

regulations, and copies of pertinent licenses, and license conditions (including 

applications and applicable correspondence), as required by 10 CFR Part 19.

L. Emergency procedures:

1. RSO name and telephone number

2. immediate steps to prevent or control spread of contamination

3. cleanup instructions, decontamination

M. Survey program:

1. survey instrument accessibility

2. who is responsible

3. types, contamination, and area

4. frequency

5. levels of contamination

6. personnel, hands, shoes

7. records

N. Waste

1. liquid

2. solids

3. sanitary sewer

4. burial (transfer to low-level waste repository)

5. storage

6. decay-in-storage

7. waste storage surveys

8. incineration

9. records

O. Dosimetry

1. whole body

2. extremities
G-3

3. lost or replacement badges and dose assessment

4. bioassay procedures

5. records

P. Instrumentation

1. survey meters—use, calibration frequency, use of check sources

2. analytical instruments—gas chromatographs, liquid scintillation counters

Q. Procedures for receiving packages containing radioactive materials.

1. normal

2. off-duty

3. notification of user and RSO

4. security

5. exposure levels

6. possession limit

7. receipt of damaged packages

R. Procedures for opening and examining packages

1. leakage and contamination

2. monitoring packages

3. monitoring packing materials

4. gloves

5. transferring material to users

S. Animal experiments

1. description of facilities

2. procedures to be performed with animals

3. safety instructions, including handling of animals, waste, carcasses, and cleaning 

and decontamination of cages

4. security

T. Sealed sources

1. leak test requirements

2. inventory requirements

3. exempt quantities

4. records

U. Other topics, as applicable

V. Question and answer period

For Laboratory Safety and Use of Radionuclides

A. Control procedures for obtaining permission to use radioactive materials at the facility; 

give limitations on quantity to be handled per user, allowed per experiment, etc.
G-4

B. Protective clothing and what laboratory apparel to wear and which equipment to use.

C. Limitations and conditions relative to handling unsealed licensed material and which

laboratory equipment to use when working with such material. As an example, discuss 

which licensed materials and what procedures should be confined to radiochemical fume 

hoods or gloveboxes. Explain what shielding or remote handling equipment should be 

used when beta or gamma emitting licensed materials are handled.

D. Routine survey and monitoring procedures to be followed for contamination control. 

Include where and how contaminated articles and glassware are to be handled and 

stored.

E. Emergency procedures concerning spills, fires, release of material, or accidental 

contamination of personnel.

F. Decontamination procedures to use and whom to contact in case of an emergency.

G. Instructions concerning transfer of licensed materials between rooms, halls, or corridors, 

if applicable.

H. Requirements for storage, labeling of containers, and identification of areas where 

licensed materials are used.

I. Personnel monitoring devices to use, where to obtain them, and exchange procedures 

and exposure results.

J. Waste disposal procedures to follow, limitations for disposal of liquid or solid wastes, and 

procedures to use for waste storage. If the program involves experiments with animals, 

procedures for cleaning animal quarters and handling animal excreta and carcasses for 

disposal.

K. Records to be maintained on use and disposal of licensed materials.

L. Prohibition of pipetting by mouth, eating, smoking, and drinking in areas where licensed 

materials are used.
APPENDIX H

FACILITIES AND EQUIPMENT CONSIDERATIONS

H-1

Below is a list of topics that should be considered when developing a description of the facilities 

and equipment that an ARDL licensee will use or otherwise have available. Not every ARDL 

applicant will need to address each topic in its application.

• Restricted areas are defined as areas where the licensee limits access to protect 

individuals against undue risks from exposure to radiation and radioactive materials. 

The application should contain detailed descriptions and diagrams of the facilities, 

including information about the shielding properties of the construction materials used. 

Scaled drawings and sketches should be submitted showing the relationship between 

restricted areas and unrestricted areas and the location of all pertinent safety-related 

equipment.

• Bench top or open work areas may be used for sealed sources, small quantities of solid 

materials in a form not likely to become airborne or dispersed, and small quantities of 

liquids of such low volatility as not to cause airborne contamination or toxicity problems. 

Trays and absorbent surface covers to catch and retain spilled liquids should be used on 

these open work surfaces and inside closed systems discussed below. Surfaces should 

be smooth and nonporous to facilitate decontamination.

• Radioactive materials that are handled or used in unsealed forms should be confined to 

control the release of material and to prevent the spread of contamination. Gaseous, 

volatile, and fine particulate solid materials should be handled in closed or isolated 

systems such as fume hoods or glove boxes with controlled, and possibly filtered, 

exhaust systems.

Chemical-type fume hoods provide a working area with controlled inward airflow from 

the room to the hood exhaust system. Hoods are used for gases, unsealed volatile 

licensed materials, and processes such as evaporation that may release gases and 

vapors. Fume hoods provide emergency ventilation and exhaust for unplanned 

releases, such as accidental spills and ruptures, as well as routine exhaust of effluents. 

Filters may be required in the exhaust stream unless monitoring or calculations 

demonstrate that any planned or likely effluent will be in accordance with the limits found 

in 10 CFR 20, Appendix B.

Glove boxes are sealed boxes with transparent viewing windows, sealable ports or 

doors for transferring materials and equipment, and gloves sealed to the box through 

which licensed materials are handled. Glove boxes are used for the containment during 

storage and use of liquids and solids that can become airborne particulates or aerosols. 

Glove boxes can be closed or exhausted, with filtration systems if appropriate, to prevent 

contamination.

• Sink faucets should be designed, where possible, for operation by foot, knee, or elbow, 

rather than by hand.
H-2

• Plumbing and ductwork should be designed to avoid radioactive contamination build-up. 

This build-up of contamination can create external radiation exposure hazards and 

problems for decommissioning.

• To reduce radiation exposure from gamma-emitting radioactive materials, shielding

consisting of lead or other high-density material in the form of bricks, panels, L-shields, 

storage containers, or other shapes may be used on bench tops, in fume hoods, or in 

glove boxes. 

• To reduce the exposure from high-energy beta-emitting materials, shielding of low

atomic number material, such as high-density plastic, may be used. 

• Shielded shipping containers frequently are used for continued storage after receipt of 

materials.

• A particular sink should be designated for disposal of liquid radioactive waste to the 

sanitary sewerage system. In some cases, depending on the number of users and 

distance between areas of use, more than one sink may need to be designated.

• Labeled waste containers should be used. These containers may be shielded as 

necessary, placed near the waste-generating areas and away from areas that personnel 

frequently occupy. Additionally, these containers should be effectively enclosed to 

prevent airborne contamination from radioactive materials deposited.

• Remote handling tools, such as forceps or extension handles, should be used to provide 

distance in the handling of radioactive materials (ALARA). In addition, shielded handling 

devices, such as shielded syringes, can be used to protect workers from materials that 

cannot be handled remotely. Pipetting should be done using appropriate devices. 

Pipetting by mouth should be strictly forbidden.

• Where appropriate, ventilation systems should be designed such that, in the event of an 

accident, they can be shut down to prevent the spread of radioactivity.

• Designated areas should be provided for coats and personal belongings, to avoid 

contamination.

• Areas with background radiation levels should be designated for personnel dosimetry 

storage when not in use.

• Areas of use should be well-lighted to avoid spills and other accidents that could result in 

contamination buildup.

• Observation of activities conducted behind shielding with remote tools (or with extended 

arms and hands, within limits consistent with permissible occupational exposures) can 

be accomplished by mirrors, through shielded (e.g., leaded glass) windows, through

transparent plastic beta shields, or by remote video monitoring.

• The combination of containment, shielding, and handling devices proposed for any use 

of radioactive materials should be appropriate to the type and quantity of materials to be 

used and to the type and duration of operations to be conducted.
H-3

• If respiratory protective equipment will be used to limit inhalation of airborne licensed 

material, you must follow the provisions of 10 CFR Part 20, Subpart H, “Respiratory 

protection and controls to restrict internal exposure in restricted areas.”

• If compaction of waste is performed, ensure that facilities are adequate for the ventilation 

of the area where the waste is compacted. In addition, also ensure that air sampling for 

internal exposures is available, if needed per 10 CFR 20.1204

APPENDIX I

SAMPLE AUDIT PROGRAM

I-1

Sample Audit Program

An audit is conducted, in part, to fulfill the requirements of 10 CFR 20.1101 for an annual review 

of the content and implementation of the licensee’s radiation protection program. Audits should 

be performance-based, and include observations of licensed activities, interviews with 

personnel, and inspection of facilities and equipment. It should also identify program 

weaknesses and allow licensees to take early corrective actions (before an NRC inspection). 

During an audit, the auditor needs to keep in mind not only the requirements of the NRC’s 

regulations, but also the licensee’s commitments in its applications and other correspondence 

with the NRC. The auditor also should evaluate whether the licensee is maintaining exposures 

to workers and the general public as low as is reasonably achievable (ALARA) and, if not, make 

suggestions for improvement.

The form in this appendix can be used to document the annual audit of the radiation protection 

program. Guidance on completing each section of the form is listed below. In the “remarks” 

portions of the form, note any deficiencies identified and the corrective actions taken (or to be 

taken).

Section 1, Audit History. Enter the date of the last audit, whether any deficiencies were 

identified, and whether actions were taken to correct the deficiencies.

Section 2, Organization and Scope of Program. Give a brief description of the organizational 

structure, noting any changes in personnel or procedures, and amendments to the license. 

Describe the scope of licensed activities at the audited location. Check if the radiation safety 

officer (RSO) is the person identified on the license and fulfills the duties specified in the license.

Section 3, Training, Retraining, and Instructions to Workers. Ensure that workers have 

received the training required by 10 CFR 19.12 Be sure that the user has received training and 

has a copy of the licensee’s safe use and emergency procedures before being permitted to use 

byproduct material. Note whether refresher training is conducted in accordance with licensee 

commitments. Ensure that each worker has a copy of the licensee’s procedures, and by 

interview or observation of selected workers that he or she can implement them.

Section 4, Audits. Verify that audits fulfill the requirements of 10 CFR 20.1101, are conducted 

in accordance with licensee commitments, and are properly documented.

Section 5, Facilities. Verify that the licensee’s facilities are as described in its license 

documents.

Section 6, Materials. Verify that the license authorizes the quantities and types of byproduct 

material that the licensee possesses.

Section 7, Leak Tests. Verify that all sealed and plated foil sources are tested for leakage at 

the prescribed frequency and in accordance with licensee commitments. Records of results 

should be maintained.

Section 8, Inventories. Verify that inventories are conducted at least once every 6 months to 

account for all sources; inventory records should be maintained.
I-2

Section 9, Radiation Surveys. Verify that the licensee has appropriate, operable, and 

calibrated survey instruments available, that the instruments are calibrated (at the required 

frequency) in accordance with license conditions and in accordance with 10 CFR 20.2103. 

Calibration records must be retained for 3 years after the record is made. Check that radiation 

levels in areas adjacent to use are within regulatory limits and in accordance with 

10 CFR 20.2103. Verify compliance with 10 CFR 20.1301. Records of surveys must be 

retained for 3 years after the record is made.

Section 10, Receipt and Transfer of Radioactive Material (Includes Waste Disposal). 

Verify that packages containing byproduct material, received from others, are received, opened, 

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

packages.” Ensure that transfers are performed in accordance with 10 CFR 30.41 Records of 

surveys, receipt, and transfer must be maintained in accordance with 10 CFR 20.2103 and 

10 CFR 30.51.

Section 11, Transportation. Determine compliance with DOT requirements, if applicable.

Section 12, Personnel Radiation Protection. Evaluate the licensee’s determination that 

unmonitored personnel are not likely to receive more than 10 percent of the allowable limits. 

Alternately, if personnel dosimetry is provided and required, verify that it complies with 

10 CFR 20.1501(c) and licensee commitments. Review personnel monitoring records; compare 

exposures of individuals doing similar work; determine reasons for significant differences in 

exposures. If any worker declared her pregnancy in writing, evaluate the licensee’s compliance 

with 10 CFR 20.1208. Check whether records are maintained as required by 10 CFR 20.2101, 

2102, 2103, 2104, and 2106.

Section 13, Auditor’s Independent Measurements (If Made). The auditor should make 

independent survey measurements and compare the results with those that the licensee made 

or used.

Section 14, Notification and Reports. Check on the licensee’s compliance with the 

notification and reporting requirements in 10 CFR Parts 19, 20, and 30. Ensure that the 

licensee is aware of the telephone number for NRC’s Emergency Operations Center

(301-816-5100).

Section 15, Posting and Labeling. Check for compliance with the posting and labeling 

requirements of 10 CFR 19.11, 20.1902, 20.1904, and 21.6.

Section 16, Recordkeeping for Decommissioning. Check to determine compliance with 

10 CFR 30.35(g) and 20.1501(b).

Section 17, Bulletins and Information Notices. Check to determine if the licensee is 

receiving such documents as bulletins, information notices, and FSME newsletters from the 

NRC. Check whether the licensee took appropriate action in response to NRC mailings.

Section 18, Special License Conditions or Issues. Verify compliance with any special 

conditions on the licensee’s license. If the licensee has any unusual aspect of its work, review 

and evaluate compliance with regulatory requirements.
I-3

Section 19, Continuation of Report Items. This section is self-explanatory.

Section 20, Problems or Deficiencies Noted; Recommendations. This section is 

self-explanatory.

Section 21, Evaluation of Other Factors. Evaluate licensee management’s involvement with 

the radiation safety program, whether the RSO has sufficient time to perform his or her duties, 

and whether the licensee has sufficient staff to handle the workload and maintain compliance 

with regulatory requirements.

Note: All areas indicated in audit notes may not be applicable to every license and may not 

need to be addressed during each audit.
I-4

Sample Checklist

Audit Report No. License No. _________________________ 

Licensee’s name and mailing address:

 

 

 

 

Audit of activities at (address):

 

 

 

Contact at Audit Location Telephone No. _______________________ 

Date of this Audit 

Summary of Findings and Action:

[ ] No deficiencies

[ ] Deficiencies

[ ] Action on previous deficiencies
I-5

Recommendations:

Auditor: Date: 

 (Signature)

1. AUDIT HISTORY [ ] N/A (N/A means “Not applicable”–Initial Audit)

A. Last audit of this location conducted 

B. Problems or deficiencies identified during last two audits or 2 years,

whichever is longer [ ] Y [ ] N

C. Open problems or deficiencies from previous audits:

Status Requirement Prob./Def. Corrective Action 

Taken (Y/N)

Open/Closed

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

D. Any previous problem or deficiency not corrected or repeated [ ] Y [ ] N [ ] N/A

Explain:

2. ORGANIZATION AND SCOPE OF PROGRAM

A. Briefly describe organizational structure

1. Structure is as described in license documents [ ] Y [ ] N

2. Multiple authorized locations of use [ ] Y [ ] N

3. Briefly describe scope of activities involving byproduct

material, frequency of use, staff size, etc. [ ] Y [ ] N

4. Amendments and program changes [ ] Y [ ] N

B. Radiation safety officer [ ] Y [ ] N

1. Authorized on license [ ] Y [ ] N

2. Fulfills duties as RSO [ ] Y [ ] N
I-6

C. Use only by authorized individuals [ ] Y [ ] N

Remarks:

3. TRAINING, RETRAINING, AND INSTRUCTIONS TO WORKERS

A. Instructions to workers per 10 CFR 19.12 [ ] Y [ ] N

B. Training program required [ ] Y [ ] N

C. Training records maintained [ ] Y [ ] N

D. Evaluation of individuals’ understanding of procedures and

regulations based on interviews, observation of selected

workers [ ] Y [ ] N

1. Each has an up-to-date copy of the licensee’s safe use and

emergency procedures

2. Adequate understanding of:

Current safe use procedures [ ] Y [ ] N

Emergency procedures [ ] Y [ ] N

E. 10 CFR Part 20

Workers cognizant of requirements for:

1. Radiation Safety Program (10 CFR 20.1101) [ ] Y [ ] N

2. Annual dose limits (10 CFR 20.1301, 20.1302) [ ] Y [ ] N

3. New NRC Forms 4 and 5 [ ] Y [ ] N

4. 10 percent monitoring threshold (10 CFR 20.502) [ ] Y [ ] N

5. Dose limits to embryo or fetus and declared pregnant

women (10 CFR 20.1208) [ ] Y [ ] N

6. Procedures for opening packages (10 CFR 20.1906) [ ] Y [ ] N

Remarks:

4. INTERNAL AUDITS, REVIEWS, OR INSPECTIONS

A. Audits are conducted [ ] Y [ ] N

1. Audits conducted by ___________________

2. Frequency ___________________
I-7

B. Content and implementation of the radiation protection

program reviewed annually (10 CFR 20.1101(c)) [ ] Y [ ] N

C. Records maintained [(0 CFR 20.2102) [ ] Y [ ] N

5. FACILITIES

A. Facilities as described in license application

B. 5. Commensurate security procedures implemented (20.1801, 20.1802; Part 37 if 

applicable) [ ] Y [ ] N

Remarks:

6. MATERIALS

Isotopes, quantities, and use as authorized on license [ ] Y [ ] N

Remarks:

7. LEAK TESTS

A. Leak test performed as described in correspondence 

with the NRC (consultant; leak test kit; licensee performed) [ ] Y [ ] N

B. Frequency: every 6 months or other interval, as approved 

by NRC or Agreement State [ ] Y [ ] N

C. Records with appropriate information maintained [ ] Y [ ] N

Remarks:

8. INVENTORIES

A. Conducted at 6-month intervals [ ] Y [ ] N

B. Records with appropriate information maintained [ ] Y [ ] N

Remarks:

9. RADIATION SURVEYS

A. Instruments and Equipment: [ ] Y [ ] N

1. Appropriate operable survey instrumentation possessed 

or readily available [ ] Y [ ] N
I-8

2. Calibrated as required (10 CFR 20.1501) [ ] Y [ ] N

3. Calibration records maintained (10 CFR 20.2103(a)) [ ] Y [ ] N

B. Briefly describe survey requirements (10 CFR 20.1501(a))

C. Performed as required (10 CFR 20.1501(a)) [ ] Y [ ] N

1. Radiation levels within regulatory limits [ ] Y [ ] N

2. Corrective action taken and documented [ ] Y [ ] N

D. Records maintained (10 CFR 20.2103) [ ] Y [ ] N

E. Protection of members of the public

1. Adequate surveys made to demonstrate either (a) that the

total dose equivalent (TEDE) to the individual likely to receive the highest dose

does not exceed 100 mrem in a year, or (b) that if an

individual were continuously present in an unrestricted

area, the external dose would not exceed 2 mrem in any

hour and 50 mrem in a year (10 CFR 20.1301(a)(1), 

20.1302(b)) [ ] Y [ ] N

2. Unrestricted area radiation levels do not exceed 2 mrem 

in any one hour (10 CFR 20.1301(a)(2)) [ ] Y [ ] N

3. Records maintained (10 CFR 20.2103, 20.2107) [ ] Y [ ] N

Remarks:

10. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL (INCLUDES WASTE 

DISPOSAL)

A. Procedures describe how packages are

received and by whom: [ ] Y [ ] N

B. Written package opening procedures established and

followed (10 CFR 20.1906(e)) [ ] Y [ ] N

C. If package shows evidence of degradation, monitor for

contamination and radiation levels [ ] Y [ ] N [ ] N/A

D. Monitoring of degraded packages performed within time

specified (10 CFR 20.1906(c)) [ ] Y [ ] N [ ] N/A

E. Transfer(s) between licensees (including “disposal”)

performed per (10 CFR 30.41) [ ] Y [ ] N [ ] N/A
I-9

F. Records of receipt or transfer maintained (10 CFR 20.2103(a),

30.51) [ ] Y [ ] N

G. Transfers within licensee’s authorized users or locations

performed as required (L/C) [ ] Y [ ] N [ ] N/A

H. Package receipt or distribution activities evaluated for

compliance with (10 CFR 20.1301, 20.1302) [ ] Y [ ] N [ ] N/A

Remarks:

11. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 170-189) [ ] N/A

A. Licensee shipments are:

1. delivered to common carriers [ ] Y [ ] N [ ] N/A

2. transported in licensee’s own private vehicle [ ] Y [ ] N [ ] N/A

3. no shipments since last audit [ ] Y [ ] N [ ] N/A

B. Hazmat Training

1. Applicability and responsibility for training and [ ] Y [ ] N [ ] N/A

testing (49 CFR 172.702))

B. Packages [ ] N/A

1. Authorized packages used (49 CFR 173.415, 173.416(b)) [ ] Y [ ] N [ ] N/A

2. Closed and sealed during transport (49 CFR 173.475(f)) [ ] Y [ ] N

C. Shipping Papers [ ] N/A

1. Prepared and used (49 CFR 172.200(a)) [ ] Y [ ] N

2. Proper shipping name, hazard class, UN number,

quantity, package type, nuclide, RQ, radioactive

material, physical and chemical form, activity, category

of label, T1, shipper’s name, certification, and signature,

Emergency response phone number, “Cargo Aircraft

Only” (if applicable) (49 CFR 172.200–204) [ ] Y [ ] N

3. Readily accessible during transport (49 CFR 177.718(e)) [ ] Y [ ] N

D. Vehicles [ ] Y [ ] N

1. Cargo blocked and braced (49 CFR 177.842(d)) [ ] Y [ ] N

2. Placarded, if needed (49 CFR 172.504) [ ] Y [ ] N
I-10

3. Proper overpacks, if used (shipping name, UN Number,

labeled, statement indicating that inner package complies

with specification package) (49 CFR 173.25) [ ] Y [ ] N

E. Any incidents reported to DOT (49 CFR 171.15, 171.16) [ ] Y [ ] N

Remarks:

12. PERSONNEL RADIATION PROTECTION

A. ALARA considerations are incorporated into the Radiation

Protection Program (10 CFR 20.1101(b)) [ ] Y [ ] N

B. Adequate documentation of determination that unmonitored

occupationally individuals are not likely to receive >10% of

allowable limit (10 CFR 20.1502(a)) [ ] Y [ ] N [ ] N/A

OR

C. External dosimetry provided and required [ ] Y [ ] N [ ] N/A

1. Supplier Frequency 

2. Supplier is NVLAP-approved (10 CFR 20.1501(c)]) [ ] Y [ ] N

3. Dosimeters exchanged at required frequency (L/C) [ ] Y [ ] N

D. Occupational intake monitored and assessed

(10 CFR 20.1502(b)) [ ] Y [ ] N [ ] N/A

E. Reports [ ] N/A

1. Reviewed by Frequency 

2. Auditor reviewed personnel monitoring records for period 

to 

3. Prior dose determined for individuals likely to receive

doses (10 CFR 20.2104) [ ] Y [ ] N

4. Maximum exposures TEDE Other 

5. NRC Forms or equivalent (10 CFR 20.2104(d), 20.2106(c))

a. NRC Form 4 “Cumulative Occupational Exposure

History” [ ] Y [ ] N

Complete: [ ] Y [ ] N
I-11

b. NRC Form 5, “Occupational Exposure Record for a

Monitoring Period” [ ] Y [ ] N

Complete: [ ] Y [ ] N

6. Worker declared her pregnancy in writing during

inspection period (review records) [ ] Y [ ] N [ ] N/A

If yes, determine compliance with (10 CFR 20.1208) [ ] Y [ ] N

Check for records per (10 CFR 20.2106(e)) [ ] Y [ ] N

F. Records of exposures, surveys, monitoring, and evaluations

maintained (10 CFR 20.2102, 20.2103, 20.2106, L/C) [ ] Y [ ] N

Remarks:

13. AUDITOR’S INDEPENDENT MEASUREMENTS (IF MADE)

A. Survey instrument Serial No. Last calibration

B. Auditor’s measurements compared to licensee’s [ ] Y [ ] N

C. Describe the type, location, and results of measurements:

14. NOTIFICATION AND REPORTS [ ] N/A

A. Licensee in compliance with (10 CFR 19.13, 30.50) (reports to

individuals, public and occupational, monitored to show

compliance with Part 20) [ ] Y [ ] N [ ] N/A

B. Licensee in compliance with (10 CFR 20.2201, 30.50)

(theft or loss) [ ] Y [ ] N [ ] None

C. Licensee in compliance with (10 CFR 20.2202, 30.50)

(incidents) [ ] Y [ ] N [ ] None

D. Licensee in compliance with (10 CFR 20.2203, 30.50)

(overexposures and high radiation levels) [ ] Y [ ] N [ ] None

E. Licensee aware of telephone number for NRC Emergency

Operations Center (301-816-5100) [ ] Y [ ] N

15. POSTING AND LABELING

A. NRC-Form 3 “Notice to Workers” is posted (10 CFR 19.11) [ ] Y [ ] N

B. 10 CFR Parts 19, 20, 21, Section 206 of Energy Reorganization Act,

procedures adopted pursuant to Part 21, and license documents
I-12

are posted, or a notice indicating where documents can be

examined is posted (10 CFR 19.11, 21.6) [ ] Y [ ] N

C. Other posting and labeling per (10 CFR 20.1902, 1904) and the license

is not exempted by (10 CFR 20.1903, 1905) [ ] Y [ ] N

Remarks:

16. RECORDKEEPING FOR DECOMMISSIONING (if needed) [ ] N/A

A. Records of information important to the safe and effective

decommissioning of the facility maintained in an independent

and identifiable location until license termination [ ] Y [ ] N

B. Records include all information outlined in (10 CFR 30.35(g)) [ ] Y [ ] N

Remarks:

17. BULLETINS AND INFORMATION NOTICES

A. Receipt of NRC Bulletins, NRC Information Notices, NMSS

newsletters [ ] Y [ ] N

B. Appropriate action taken in response to bulletins, information

notices [ ] Y [ ] N

Remarks:

18. SPECIAL LICENSE CONDITIONS OR ISSUES [ ] N/A

A. Review special license conditions or other issues, and describe findings:

B. Problems or deficiencies identified at licensee facilities other than at audit location:

C. Evaluation of compliance:

19. CONTINUATION OF REPORT ITEMS [ ] N/A

(If more space is needed, use separate sheets and attach to report.)

20. PROBLEMS OR DEFICIENCIES NOTED; RECOMMENDATIONS [ ] N/A
I-13

Note: Briefly state (1) the requirement and (2) how and when violated. Provide 

recommendations for improvement.

21. EVALUATION OF OTHER FACTORS

A. Senior licensee management is appropriately involved with the

radiation safety program or radiation safety

officer (RSO) oversight [ ] Y [ ] N

B. RSO has sufficient time to perform his or her radiation safety

duties and is not too busy with other assignments [ ] Y [ ] N

C. Licensee has sufficient staff [ ] Y [ ] N

Remarks and recommendations:

APPENDIX J

RADIATION MONITORING INSTRUMENT SPECIFICATIONS AND 

MODEL SURVEY INSTRUMENT AND AIR SAMPLER CALIBRATION 

PROGRAM

J-1

Radiation Monitoring Instrument Specifications

The specifications in Table K.1 will help applicants and licensees choose the proper radiation 

detection equipment for monitoring the radiological conditions at their facility(ies). Additional 

information about instruments and their uses also can be found in NUREG-1575, “Multi-Agency 

Radiation Survey and Sited Investigation Manual (MARSSIM),” Chapter 6 and Appendix H.

Table J.1 Typical Survey Instruments1

 

(Instruments used to measure radiological conditions at licensed facilities.)

Portable Instruments Used for Contamination and Ambient Radiation Surveys

Detectors Radiation Energy Range Efficiency

Exposure Rate Meters Gamma, 

X-Ray

μR-R N/A

Count Rate Meters

GM Alpha All energies (dependent on window thickness) Moderate

Beta All energies (dependent on window thickness) Moderate

Gamma All energies < 1%

NaI Scintillator Gamma All energies (dependent on crystal thickness) Moderate

Plastic Scintillator Beta C-14 or higher (dependent on window thickness) Moderate

Stationary Instruments Used to Measure Wipe, Bioassay, and Effluent Samples

Detectors Radiation Energy Range Efficiency

LSC* Alpha All energies High

Beta All energies High

Gamma Moderate

Gamma Counter 

(NaI)*

Gamma All energies High

Gas Proportional Alpha All energies High

Beta All energies Moderate

Gamma All energies < 1%

1 Table from The Health Physics and Radiological Health Handbook, Revised Edition, edited by Bernard Shleien, 

1992 (except for * items).

In addition to selecting an instrument that is appropriate for the radiation(s) of interest, it is 

important to know if the instrument is sufficiently sensitive so as to make measurements at the 

required level. This is particularly important for measurements such as for leak test samples, 
J-2

bioassay measurement, and decommissioning of facilities or equipment. The “minimum 

detectable activity” (MDA) for your instrument should be a small fraction (10 to 50 percent) of 

the criteria you must meet. 

Example 1: A sealed source is considered to be leaking if a removable contamination exceeds 

185 becquerels (0.005 microcurie, or 11,100 disintegrations per minute (dpm)). The instrument 

used to measure wipe test samples should have an MDA of 10 percent of that limit, or 

1,100 dpm for the radionuclide being tested; this is usually easy to detect for cobalt-60 or

cesium-137, but more difficult to detect for nickel-63, depending on the instrument used to 

analyze the sample.

Example 2: You are closing a laboratory where uranyl acetate (generally licensed 

pursuant to 10 CFR 40.22, “Small quantities of source material”) was used. The total residual 

contamination screening value for uranium-238 is 101 dpm/100 cm2

. The MDA for direct 

measurements of uranium-238 should be made at 10 to 50 percent of the screening value for 

uranium-238, or 10 to 50 dpm/100 cm2

. 

When the sample count time and the background count time are the same, a simplified 

calculation can be used to determine the MDA for a static measurement. This simplified 

calculation assumes that the Type I error (false positive) and Type II error (false negative) are 

both selected to be equal in probability and at the 95 percent confidence error. 

Note 1: This calculation can be modified for more complex situations as described in

NUREG-1575, Chapter 6, “Field Measurements Methods and Instrumentation.”

Note 2: This equation applies only to instruments used in scalar mode, accumulating

counts of radiation detected over a defined period of time. It is NOT applicable to survey 

instruments used in rate meter mode.

This simplified equation is:

MDA = (3 + 4.65√B)

 €t

Where B = number of background counts

t = minutes of background count = minutes of sample count

€ = efficiency of instrument, determined using a calibration standard

€ = [(cpm from std) - (cpm from bkg)] = efficiency in c/d

activity of std in dpm

where: cpm = counts per minute

std = standard

bkg = background

Example:

A gas-flow proportional counter is used in scalar mode to make 1-minute counts of samples.

sample count time = 1 minute = t
J-3

background count time = 1 minute = t

background counts = 300 counts

efficiency = 0.15 counts/disintegrations (c/d) = €

Then MDA = (3 + 4.65√B) = (3 + 4.65√300 counts) 

 €t (0.15 c/d)(1 minute)

= 557 dpm

According to this calculation, you would be confident that 95 percent of the time, the instrument

can reliably detect measurements as low as 557 dpm. This is the minimum activity that the 

instrument can detect; results below this number are not reliable at the 95 percent confidence 

interval. However, all numerical results should be recorded. From the basic MDA, you can 

determine the minimum detectable concentration (MDC) for your actual measurement 

conditions. 

For example, suppose the above measurement was made with a survey meter probe with a 

surface area of 15 square centimeters (cm2

),); then the MDC would be calculated as follows:

MDC = 557 dpm/15 cm2 = 37 dpm/ cm2 or 3700 dpm/100 cm2

 

Determining the MDA or MDC for instruments used in rate meter mode and for scanning 

surveys is more complicated. If you will be performing surveys for decommissioning, which 

require direct measurement surveys, scanning measurement surveys, and surveys for 

removable contamination, review NUREG-1757, “Consolidated Decommissioning Guidance.” 

Additional information related to determining the MDA and MDC for direct measurements and 

scanning measurements may be found in Chapter 6 and Appendix H of NUREG-1575.

Model Instrument Calibration Program

Training

Before allowing an individual to perform survey instrument calibrations, the RSO will ensure that 

he or she has sufficient training and experience to perform independent survey instrument 

calibrations.

Classroom training may be in the form of lecture, videotape, or self-study and will cover the 

following subject areas:

• principles and practices of radiation protection

• radioactivity measurements, monitoring techniques, and using instruments

• mathematics and calculations basic to using and measuring radioactivity

• biological effects of radiation

Appropriate on-the-job-training consists of the following:

• Observing authorized personnel performing survey instrument calibration.
J-4

• Conducting survey meter calibrations under the supervision and in the physical presence 

of an individual authorized to perform calibrations.

Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments

• To reduce doses received by individuals not calibrating instruments, calibrations will be 

conducted in an isolated area of the facility or at times when no one else is present.

• Individuals conducting calibrations will wear assigned dosimetry.

• Individuals conducting calibrations will use a calibrated and operable survey instrument 

to ensure that unexpected changes in exposure rates are identified and corrected.

• The calibration source should be well-collimated, and the calibration area should be 

designed to minimize scatter of radiation, which could affect the calibration process.

• The calibration area should be appropriately controlled so that persons entering the area 

will be aware if a radiation source is in use. Posting as a radiation area also may be 

required.

• Depending on the type of calibrator or irradiator source used for calibration, the device 

and facilities may be regulated under 10 CFR Part 36, “Licenses and Radiation Safety 

Requirements for Irradiators,” and require interlocks and alarms. Review NUREG-1556, 

Volume 5, “Program-Specific Guidance about Self-Shielded Irradiator Licenses” and 

Volume 6 “Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses,” for

additional guidance.

Model Procedure for Calibrating Survey Instruments

Instruments should be calibrated before first use, and at least annually thereafter. Instruments 

also should be calibrated after any repair to the instrument.

A radioactive sealed source(s) used for calibrating survey instruments will:

• Approximate a point source

• Have its apparent source activity or the exposure rate at a given distance traceable by 

documented measurements to a standard certified by the National Institutes of 

Standards and Technology (NIST)

• Approximate the same energy and type of radiation as the environment in which the 

calibrated device will be used

• For dose rate and exposure rate instruments, the source should be strong enough to 

give an exposure rate of at least about 7.7 x 10-6 coulombs/kilogram/hour (30 mR/hr) at 

100 cm [e.g., 3.1 gigabecquerels (85 mCi) of cesium-137 or 7.8 x 102 megabecquerels 

(21 mCi) of cobalt-60]
J-5

The three kinds of scales frequently used on dose or dose rate survey meters are calibrated as 

follows:

• Linear readout instruments with a single calibration control for all scales shall 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 shall be adjusted on 

each scale. After adjustment, the response of the instrument shall be checked at 

approximately 20 percent and 80 percent of full scale. The instrument’s readings shall 

be within ±15 percent of the conventionally true values for the lower point and 

±10 percent for the upper point.

• Logarithmic readout instruments, which commonly have a single readout scale spanning 

several decades, normally have two or more adjustments. The instrument shall be 

adjusted for each scale according to site specifications or the manufacturer’s 

specifications. After adjustment, calibration shall be checked at a minimum of one point 

on each decade. Instrument readings shall have a maximum deviation from the 

conventionally true value of no more than 10 percent of the full decade value.

• Meters with a digital display device shall be calibrated the same as meters with a linear 

scale.

• Readings above 2.58 X 10-4 coulomb/kilogram/hour (1 R/hr) need not be calibrated, but 

such scales should be checked for operation and response to radiation.

• The inverse square and radioactive decay law should be used to correct changes in 

exposure rate because of changes in distance or source decay.

Surface Contamination Measurement Instruments1

• Survey meters’ efficiency must be determined by using radiation sources with similar 

energies and types of radiation that the survey instrument will be used to measure.

• If each scale has a calibration potentiometer, the reading shall be adjusted to read the 

conventionally true value at approximately 80 percent of full scale, and the reading at 

approximately 20 percent of full scale shall be observed. If only one calibration 

potentiometer is available, the reading shall be adjusted at mid-scale on one of the 

scales, and readings on the other scales shall be observed. Readings shall be within 

20 percent of the conventionally true value.

Model Procedures for Calibrating, Liquid Scintillation Counters, Gamma Counters, Gas 

Flow Proportional Counters, and Multichannel Analyzers

A radioactive sealed source used for calibrating instruments will do the following:

• Approximate the geometry of the samples to be analyzed

 1

 ANSI N323A-1997, “Radiation Protection Instrumentation Test and Calibration.”
J-6

• Have its apparent source activity traceable by documented measurements to a standard 

certified by the National Institutes of Standards and Technology (NIST)

• Approximate the same energy and type of radiation as the samples that the calibrated 

device will be used to measure

Calibration

• Calibration must produce readings within ± 20 percent of the actual values over the 

range of the instrument.

• Calibration of liquid scintillation counters will include quench correction.

Calibration Records

Calibration records, for all survey instruments, should indicate the procedure used and the data 

obtained. The description of the calibration should include:

• the owner or user of the instrument

• a description of the instrument, including the manufacturer’s name, model number, serial 

number, and type of detector

• a description of the calibration source, including the exposure rate at a specified 

distance or activity on a specified date

• for each calibration point, the calculated exposure rate or count rate, the indicated 

exposure rate or count rate, the deduced correction factor (the calculated exposure rate 

or count rate divided by the indicated exposure rate or count rate), and the scale 

selected on the instrument

• for instruments with external detectors, the angle between the radiation flux field and the 

detector (i.e., parallel or perpendicular)

• for instruments with internal detectors, the angle between radiation flux field and a 

specified surface of the instrument

• for detectors with removable shielding, an indication whether the shielding was in place 

or removed during the calibration procedure

• the exposure rate or count rate from a check source, if used

• the name of the person who performed the calibration and the date it was performed.

The following information should be attached to the instrument as a calibration sticker or tag:

• for exposure rate meters, the source isotope used to calibrate the instrument (with 

correction factors) for each scale
J-7

• the efficiency of the instrument, for each isotope the instrument will be used to measure 

(if efficiency is not calculated before each use)

• for each scale or decade not calibrated, an indication that the scale or decade was 

checked only for function but not calibrated

• the date of calibration and the next calibration due date

• the apparent exposure rate or count rate from the check source, if used

Air Sampler Calibration

In order to assess accurately the air concentration of radioactive materials in a given location, 

the volume of air sampled and the quantity of contaminant in the sample must be determined. 

Accurate determination of the volume of air sampled requires standard, reproducible, and 

periodic calibration of the air metering devices that are used with air sampling instruments.

The publication entitled, “Air Sampling Instruments,” found in the 9th edition, American 

Conference of Governmental Industrial Hygienists, 2001, provides guidance on total air sample 

volume calibration methods acceptable to NRC staff, as supplemented below.

Frequency of Calibration

• A licensee committed to a routine or emergency air sampling program should perform an 

acceptable calibration of all airflow or volume metering devices at least annually (see 

Regulatory Guide 8.25, “Air Sampling in the Workplace”).

• Special calibrations should be performed at any time there is reason to believe that the 

operating characteristics of a metering device have been changed, by repair or 

alteration, or whenever system performance is observed to have changed significantly.

• Routine instrument maintenance should be performed as recommended by the 

manufacturer.

• Primary or secondary standard instruments used to calibrate air sampling instruments 

should be inspected frequently for consistency of performance.

Error Limit for Measurement of Air Sample Volume

Most methods of calibrating airflow or air volume metering devices require direct comparison to 

a primary or secondary standard instrument to determine a calibration curve or a correction 

factor. An example of a primary standard is a spirometer that measures total air volume directly 

with high precision by liquid displacement. An example of a secondary standard is a wet-test 

meter that has been calibrated against a primary standard. Primary standards are usually 

accurate to within ±1 percent and secondary standards to within ±2 percent.

The following are significant errors associated with determining the total air volume sampled:
J-8

EC: The error in determining the calibration factor. (An acceptable estimate is the 

percentage error associated with the standard instrument used in the calibration.)2

ES: Intrinsic error in reading the meter scale. (An acceptable estimate is the percentage 

equivalent of one-half of the smallest scale division, compared to the scale reading.)

Et: The percentage error in measurement of sampling time that should be kept within 

1 percent.

EV: The most probable value of the cumulative percentage error in the determination of the 

total air volume sampled.

EV: Can be calculated from the following equation, provided there are no additional 

significant sources of errors:

EV = [ES

2 + EC2 + Et2

]

1/2

The most probable value of the cumulative error EV, in the determination of total volume, should 

be less than 20 percent.

A sample calculation of the most probable value of the cumulative error in total volume 

measured is as follows: If accuracies of the scale reading, the calibration factor, and sample 

time are ± 4, 2, and 1 percent, respectively, and there are no other significant sources of error, 

the cumulative error would be:

EV = [42 + 22 + 12

]

1/2 = 4.58% or approx. 5%

If there are significant differences in pressure and temperature between the calibration site and 

the sampling site, appropriate corrections should be made using the ideal gas laws provided 

below:

Vs = V1 * (P1/760) * (273/T1)

where Vs = volume at standard conditions (760 mm and 00 C)

V1 = volume measured at conditions P1 and T1

T1 = temperature of V1 in 0

K

P1 = pressure of V1 in mm Hg

Documentation of Calibration of Air Metering Devices

The licensee should maintain records of all routine and special calibrations of airflow or volume 

metering devices, including the primary or secondary standard used, method employed, and 

 2 The calibration factor should be based on two kinds of determinations. First, correction factors should be

 determined at several flow rates distributed over the full-scale range. Each flow rate correction factor should be

 determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets

 of data should be compared. Second, subsequent calibrations should compare the new correction factors to

 those determined during the previous calibration. If observed differences are significant compared to the overall

 volume error limit of 20 percent, an additional error term should be included in the calculation above.
J-9

estimates of accuracy of the calibrated metering devices. All instruments should be labeled 

clearly as to the date and results of the most recent calibration and should include the 

appropriate correction factors to be used.

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

copy of:

• Regulatory Guide 8.25, “Air Sampling in the Workplace,” Revision 1, June 1992.

• NUREG-1400, “Air Sampling in the Workplace,” September 1993.

• Handbook of Health Physics & Radiological Health, Revised Ed., Edited by 

Bernard Shleien, Scinta, Inc., Silver Spring, MD, 1992.

• Handbook of Health Physics & Radiological Health, 3rd Ed., Edited by Bernard Shleien, 

Lester A. Slaback, Jr., and Brian Kent Birky, Lippincott Williams & Wilkins, 1998.

• ANSI N323A-1997, “American National Standard Radiation Protection Instrumentation 

Test and Calibration, Portable Survey Instruments,” New York, NY, 1997, 

<http://www.ansi.org>.

• Air Sampling Instruments, 9th Ed., American Conference of Governmental Industrial 

Hygienists, 2001.

APPENDIX K

MATERIAL RECEIPT AND ACCOUNTABILITY

K-1

The academic, research and development licensee is authorized to possess only the 

radionuclides in the types and forms listed on the license, and the total quantity possessed 

under the license shall not exceed the maximum possession limit listed on the license. 

Therefore, the RSO must know how much material is possessed under the license, in all 

locations, at any time. The licensed inventory includes all radioactive materials in use, in 

storage, and in waste. The regulations in 10 CFR 30.51 require the licensee to maintain 

records of receipt, transfer, and disposal of all licensed materials. 

Sample Procedure for Ordering and Receiving Radioactive Material

• The RSO should approve or place all orders for radioactive material and should ensure 

that the requested material, quantities (and for sealed sources and devices, the 

manufacturer and model of the source or device), are authorized by the license and that 

the possession limits are not exceeded.

• During normal working hours, carriers should be instructed to deliver radioactive 

packages directly to the RSO (or designated receiving area).

• During off-duty hours, security or other designated trained personnel should accept 

delivery of radioactive packages in accordance with the procedure outlined in the sample 

memorandum below:

Sample Memorandum 

Memorandum for Security Personnel

From: RSO, President, Vice President, etc.

Subject: Procedures for Receipt of Packages Containing Radioactive Material

If the package appears to be damaged, immediately contact the RSO. Ask the carrier 

to remain at the facility until it can be determined that neither the carrier nor the vehicle 

is contaminated.

Any packages containing radioactive material that arrive between (state times, 

e.g., 4:30 p.m. and 7:00 a.m. or on Saturdays or Sundays) shall be signed for by the 

security guard (or other designated trained individual) on duty and taken immediately 

to the designated receiving area. Security personnel (or other designated trained 

individual) should unlock the door, place the package in the designated secured 

storage area, and relock the door.

Radiation Safety Officer (RSO): 

Office Phone: 

Home Phone: 
K-2

For additional information on worker training, see the section, “Training for Individuals Working 

In or Frequenting Restricted Areas.”

Sample Procedure for Safely Opening Packages Containing Licensed Materials

For packages received under the specific license, authorized individuals shall implement 

procedures for opening each package, as follows:

• Wear gloves to prevent hand contamination.

• Visually inspect the package for any sign of damage (e.g., crushed, punctured). If 

damage is noted, stop and notify the RSO.
K-3

• Monitor the external surfaces of a labeled package according to specifications in 

Table 8.4, Section 13.14, Item 10.

• Check DOT White I, Yellow II, or Yellow III label or packing slip for activity of contents, 

so shipment does not exceed license possession limits.

• Open the outer package (following supplier’s directions if provided). Open inner 

package to verify contents (compare requisition, packing slip and label on the bottle or 

other container). Check integrity of the final source container (e.g., inspecting for 

breakage of seals or vials, loss of liquid, discoloration of packaging material, high count 

rate on smear). Again check that the shipment does not exceed license possession 

limits. If you find anything other than expected, stop and notify the RSO.

• Survey the packing material and packages for contamination before discarding. If 

contamination is found, treat as radioactive waste. If no contamination is found, 

obliterate the radiation labels before discarding in the regular trash.

• Maintain records of receipt, package survey, and wipe test results.

• Notify the final carrier and the administrator of the appropriate NRC) Regional Office 

listed in Appendix D, “United States Nuclear Regulatory Commission Regional Offices,” 

to 10 CFR Part 20, when removable radioactive surface contamination exceeds the 

limits of 10 CFR 71.87(I); or external radiation levels exceed the limits of 10 CFR 71.47, 

“External radiation standards for all packages.”

• Sample Procedure for Accountability for Unsealed Materials. The RSO should

maintain an accountability log (inventory) of all radioactive materials possessed under 

the license which demonstrates that the license limits are not exceeded, that all 

materials received are accounted for, and that material is disposed of or transferred 

before being removed from the current inventory. 

• For each radionuclide listed on the license, the RSO should maintain a record of each 

shipment of material received under the license and indicate the total amount possessed 

from all shipments. 

• Each AU who receives material should maintain a log showing the receipt of each vial, 

and the use and disposal of the material. Material may be tracked by vial, order, or by

some other unit that can be “counted.”

• Each AU should maintain records of the locations and quantities of licensed materials for 

which the AU is responsible. For example, material may be present in stock vials, 

ampoules, TLC or HPLC samples, and in various waste forms; materials may be stored 

in such places as refrigerators, freezers, cold rooms, or lab rooms.

• Each AU should periodically submit to the RSO an inventory of all licensed materials in 

the laboratory. (Note: the licensee should state in its radiation safety program 

procedures the frequency of such inventory submissions, which may be weekly, monthly 

or quarterly, or after each order, depending on the frequency of use and the amount of 
K-4

materials on hand). Each AU should indicate if material possessed was disposed of or 

transferred from his or her responsibility (examples: waste in containers may be 

transferred to a common DIS storage location under the responsibility of the RSO or 

another AU; or the AU may have disposed of licensed materials to the sewer; or the AU 

may have transferred a vial of material to another AU.)

• The license accountability log (inventory) may be maintained in hard copy or electronic 

records.

Sample Transfer Policy Statements

Internal Transfers

Licensed materials that may be transferred from one department or laboratory or AU’s control to 

another should have prior approval from the RSO. The RSO should develop a written transfer 

procedure to ensure that transfers are done in accordance with the license conditions. All 

transfers shall be done in a way that minimizes the probability of spillage or breakage. Double 

containers should be used, including suitable shielding, for such transfers.

External Transfers

Licensed material shall not be transferred or shipped from one institution to another without the 

approval of the RSO. Such transfers or shipments must be packaged and labeled in 

accordance with DOT, NRC, or U.S. Postal Service regulations, whichever is applicable. Before

any transfer from the licensee, the RSO shall verify that the recipient is authorized to receive the

licensed material, as required by 10 CFR 30.41.

Gifts

On occasion, licensees may be offered or have donated licensed materials by other individuals 

as gifts (e.g., a retiring medical practitioner donating his cesium needles to the university 

medical center). All such gifts of radioactive materials must be transferred to the licensee and 

handled in accordance with NRC requirements and the conditions of the license. In any case, 

the RSO should approve the gift before the transfer.
APPENDIX L

PUBLIC DOSE

L-1

This appendix describes methods for determining radiation doses to members of the public. 

Licensees must ensure that:

• The radiation dose received by individual members of the public does not exceed 

1 millisievert (mSv) [100 millirem (mrem)] in 1 calendar year resulting from the licensee’s 

possession or use of licensed materials.

• The radiation dose in unrestricted areas does not exceed 0.02 mSv (2 mrem) in any 

1 hour.

Members of the public include persons who live, work, study, or may be near locations where 

byproduct material is used or stored and employees whose assigned duties do not include the 

use of byproduct material but may work in the vicinity where such materials are used or stored.

Doses to Members of the Public

INCLUDES doses from:

• Radiation and/or radioactive material 

released by a licensee

• Sources of radiation under the control of 

a licensee

• Air effluents from sources of licensed 

radioactive materials

DOES NOT INCLUDE doses from:

• Sanitary sewerage discharges from

licensees

• Natural background radiation

• Medical administration of radioactive 

material

• Voluntary participation in medical research

Typical unrestricted areas may include offices, shops, laboratories (where licensed material is 

not used or stored), areas outside buildings, property, and storage areas. The licensee does 

not control access to these areas for purposes of controlling exposure to radiation or 

radioactive materials, but the licensee may control access to these areas for other reasons, 

such as security.

The licensee may show compliance with the annual dose limit for individual members of the 

public by:

• Demonstrating by measurement or calculation that the TEDE to the individual likely to 

receive the highest dose at the boundary of the unrestricted area does not exceed 

1 mSv (100 mrem)

• Demonstrating that the annual average concentration of radioactive material released in 

gaseous and liquid effluents at the boundary of the unrestricted area does not exceed 

the values specified in Table 2 of Appendix B to Part 20; and if an individual were 

continuously present in an unrestricted area the dose from external sources would not 

exceed 0.02 mSv (2 mrem) in 1 hour and 0.5 mSv (0.05 rem) in 1 year.

• Demonstrating that air emissions of radioactive materials do not result in doses greater 

than the constraint limit of 0.1 mSv (10 mrem) TEDE.
L-2

In order to perform a dose assessment, licensees should identify all potential sources of 

external and internal radiation exposure to members of the public and all locations of use, 

transport, and storage of radioactive material at their facilities. Licensees must then take 

radiation measurements or perform calculations to demonstrate compliance.

Measurements

The licensee may use measurements to demonstrate that the average annual releases are 

within regulatory limits, as well as to demonstrate that the TEDE to the individual likely to 

receive the highest dose at the boundary of the unrestricted area does not exceed 1 mSv 

(100 mrem). These measurements may include:

• dose rate surveys for radiation exposures from external radiation sources

• measurements of radionuclides in air and water effluent

The method used to measure dose will depend on the nature of the radiation source. If the 

source of radiation is constant, it may be adequate to measure the dose rate and integrate it 

over time. If the source of radiation differs or changes over time, it may be necessary to 

perform continuous measurements.

Radioactivity releases may be determined by effluent monitoring or effluent sampling and 

analysis. Airborne effluents may be discharged when volatile materials are used, such as 

during iodinations, but the discharge usually is not continuous since volatile materials are often 

used periodically rather than continuously. Liquid effluents may be discharged continuously or 

may be stored and subsequently discharged on a batch basis. For each type of source and for 

each route of potential exposure, consider the location of measurement points, whether 

continuous or periodic monitoring is required, the frequency of sampling and measurement, and 

any additional information. For discharges of airborne radionuclides, for example, it may be 

necessary to obtain information on the efficiency of filters and the air flow rate of the discharge 

system, as well as meteorological data and the distance to the nearest individual member of the 

public.

Calculation Method

Using a calculation method, the licensee must determine the highest dose an individual is likely 

to receive at the boundary of the unrestricted area. The licensee must take into account the 

individual’s exposure from external sources and the concentration of radionuclides in gaseous 

and liquid releases. In practice, the licensee may wish to make conservative assumptions to 

simplify the dose calculation.

The public dose limit applies to the individual who is likely to receive the highest dose from

licensed operations. Therefore, the dose calculations must consider the location with the 

potential for the highest internal and external exposures. A conservative calculation should 

assume that the individual was continuously present 24 hours a day, 365 days a year, or an 

occupancy factor of 1 (see Table L.1). If the result of the calculation using an occupancy factor 

of 1 demonstrates that the public dose limit is not exceeded, then there is no need for further 

evaluation.
L-3

If the calculation demonstrates that the public dose limit is exceeded with an occupancy factor 

of 1, then more realistic assumptions of the individual’s occupancy at the points of highest 

internal and external exposures may be made. The licensee may use the occupancy factors in 

Table L.1 or may calculate a specific occupancy factor by determining the likely fraction of time 

that the individual is present.

Table L.1 Standard Occupancy Factors 

Occupancy 

Factor

Description

1 Work areas such as offices, laboratories, shops, and occupied space in nearby buildings 

or outdoor areas

1/4 Corridors, lounges, elevators using operators, or unattended parking lots

1/16 Waiting rooms, rest rooms, stairways, unattended elevators, janitor’s closets, outside 

areas used only for pedestrians or vehicular traffic

Records

The licensee must maintain records to demonstrate compliance with the dose limit for individual 

members of the public until the Commission terminates the license. In general, survey and 

monitoring records of ambient radiation and effluent radioactivity should be adequate.

Records demonstrating the dose to an individual member of the public should identify the 

instruments used in the survey, the name of the surveyor, the date of the survey, the location of 

the survey(s) including a description or drawing of the area surveyed, survey results, and if 

applicable, the occupancy factors used and justification for their use. In addition, records 

demonstrating the dose to an individual member of the public that involve effluent sampling 

analysis should include information on concentrations of specific radionuclides, minimum 

detectable activity of the system, and the estimated uncertainty of measurements.

APPENDIX M

GENERAL TOPICS FOR SAFE USE OF RADIONUCLIDES AND

MODEL EMERGENCY PROCEDURES

M-1

Each laboratory or area where radioactive material is used or stored should have general rules, 

so that workers know what is required. Typical instructions should include:

• Wear a laboratory coat or other protective clothing at all times in areas where licensed 

materials are used.

• Wear disposable gloves at all times when handling licensed materials.

• After each procedure or before leaving the area, monitor hands, shoes, and clothing for

contamination in a low-background area.

• Do not eat, drink, smoke, or apply cosmetics in any area where licensed material is 

stored or used.

• Do not store food, drink, or personal effects in areas where licensed material is stored or 

used (see Figure M.1).

• Wear personnel monitoring devices, if required, at all times while in areas where 

licensed materials are used or stored.

• Dispose of radioactive waste only in designated, labeled, and properly shielded 

receptacles.

• Never pipette by mouth.

• Store radioactive solutions in clearly labeled containers.

Secure all licensed material when it is not under the constant surveillance and 

immediate control of the user(s).
M-2

Figure M.1 Storage of Food and Drink

Food or drink shall not be stored in refrigerators with radionuclides.

Radionuclide-specific Procedures

Licensees should develop written procedures for use of different radionuclides so that users 

know the types of shielding, protective clothing, survey instruments, surveys, and 

decontamination activities required. Examples of such procedures are included below.

Example 1:

If requesting more than 37 MBq (1 mCi) of iodine-125 or iodine-131, special safety instructions 

should be provided to users, including the following:

• A mandatory radiation survey and wipe test for radioactive contamination after each use

• Bioassay procedures for individuals working with millicurie quantities of radioiodine

• The use of vented hoods for iodination and for storage of millicurie quantities of 

radioiodine

• A dry run before the performance of unfamiliar procedures, to preclude unexpected 

complications. In addition, it is recommended that the RSO be present during new 

procedures

• Procedures for measuring the concentration of radioiodine effluents from the hoods
M-3

Example 2:

If requesting more than 37 MBq (1 mCi) of phosphorus-32, special safety instructions should be 

provided to users, including the following:

• The use of low-density plastic shielding to keep bremsstrahlung radiation to a minimum

• A mandatory radiation survey and wipe test for radioactive contamination after each use 

• The use of extremity monitors for procedures that involve 1 millicurie or more

• A dry run before the performance of unfamiliar procedures to preclude unexpected 

complications. In addition, it is recommended that the RSO be present during new 

procedures

• The use of eye protection for procedures that involve 10 millicuries or more

Sample Procedures for Handling Emergencies

Appropriate first aid and other immediate medical needs of injured individuals should not be 

neglected, delayed, or ignored due to suspected contamination.

General Safety Procedures to Handle Spills

• Name and telephone number of RSO or an alternate person(s) should be posted 

conspicuously in areas of use, so that it is readily available to workers in case of 

emergencies. Licensee should have emergency equipment readily available for 

handling spills. Spill kits should include the following:

− disposable gloves

− housekeeping gloves

− disposable lab coats

− disposable head coverings

− disposable shoe covers

− roll of absorbent paper with plastic backing

− masking tape

− plastic trash bags with twist ties

− “Radioactive Material” labeling tape

− marking pen

− pre-strung “Radioactive Material” labeling tags

− box of wipes

− instructions for “Emergency Procedures”

− clipboard with a copy of the Radioactive Spill Report Form for the facility
M-4

− pencil

− appropriate survey instruments including batteries (for survey meters)

Minor Spills of Liquids and Solids

• Instructions to Workers

− Notify persons in the area that a spill has occurred.

− Prevent the spread of contamination by covering the spill with absorbent paper. 

(Paper should be dampened if solids are spilled.)

− Clean up the spill, wearing disposable gloves and using absorbent paper.

− Carefully fold the absorbent paper with the clean side out and place in a plastic bag for 

transfer to a radioactive waste container. Put contaminated gloves and any other 

contaminated disposable material in the bag.

− Survey the area with an appropriate low-range radiation detector survey meter or other 

appropriate technique. Check the area around the spill for contamination. Also check 

hands, clothing, and shoes for contamination.

− Report the incident to the RSO promptly.

− Allow no one to return to work in the area unless approved by the RSO.

− Cooperate with RSO and RSO staff (e.g., investigation of root cause, provision of 

requested bioassay samples).

− Follow the instructions of the RSO and RSO staff (e.g., decontamination techniques, 

surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

 

− Follow up on the decontamination activities and document the results.

− As appropriate, determine cause and corrective actions needed; consider bioassays if 

licensed material may have been ingested, inhaled, or absorbed through the skin.

− If necessary, notify the NRC.

Major Spills of Liquids and Solids

• Instructions to Workers

− Clear the area. If appropriate, survey all persons not involved in the spill and vacate 

the room.
M-5

− Prevent the spread of contamination by covering the spill with absorbent paper (paper 

should be dampened if solids are spilled), but do not attempt to clean it up. To prevent 

the spread of contamination, limit the movement of all personnel who may be 

contaminated.

− Shield the source only if it can be done without further contamination or significant 

increase in radiation exposure.

− Close the room and lock or otherwise secure the area to prevent entry. Post the room 

with a sign to warn anyone trying to enter that a spill of radioactive material has 

occurred.

− Notify the RSO immediately.

− Survey all personnel who could possibly have been contaminated. Decontaminate 

personnel by removing contaminated clothing and flushing contaminated skin with 

lukewarm water and then washing with a mild soap.

− Allow no one to return to work in the area unless approved by the RSO.

− Cooperate with RSO and RSO staff (e.g., investigation of root cause, provision of 

requested bioassay samples).

− Follow the instructions of the RSO and RSO staff (e.g., decontamination techniques, 

surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

− Confirm decontamination of personnel. If decontamination of personnel was not fully 

successful, consider inducing perspiration by covering the area with plastic. Then 

wash the affected area again to remove any contamination released by the 

perspiration.

− Supervise decontamination activities and document the results. Documentation 

should include location of surveys and decontamination results.

− Determine cause and needed corrective actions; consider need for bioassays if 

licensed material may have been ingested, inhaled, or absorbed through the skin.

− If necessary, notify the NRC.

Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases

• Instructions to Workers

− Notify all personnel to vacate the room immediately.
M-6

− Shut down ventilation system, if appropriate, to prevent the spread of contamination 

throughout system and other parts of facility.

− Vacate the room. Seal the area, if possible.

− Notify the RSO immediately.

− Ensure that all access doors to the area are closed and posted with radiation warning 

signs, or post guards (trained) at all access doors to prevent accidental opening of the 

doors or entry to the area.

− Survey all persons who could have possibly been contaminated. Decontaminate as 

directed by the RSO.

− Promptly report suspected inhalations and ingestions of licensed material to the RSO.

− Decontaminate the area only when advised or supervised by the RSO.

− Allow no one to return to work in the area unless approved by the RSO.

− Cooperate with RSO and RSO staff (e.g., investigation of root cause, provision of 

requested bioassay samples).

− Follow the instructions of the RSO and RSO staff (e.g., decontamination techniques, 

surveys, provision and collection of bioassay samples, requested documentation).

• Reminders to RSO

− Supervise decontamination activities.

− Perform air sample surveys in the area before permitting resumption of work with 

licensed materials

− Provide written directions to potentially contaminated individuals about providing and 

collecting urine, breath, blood, or fecal samples, etc.

− Consider the need for medical exam or whole body count before permitting involved 

individuals to return to work with licensed material.

− Determine cause and corrective actions needed; consider need for bioassays if 

licensed material may have been ingested, inhaled, or absorbed through the skin. 

Document incident.

− If necessary, notify the NRC.
M-7

Minor Fires

• Instructions to Workers

− Immediately attempt to put out the fire by approved methods (i.e., fire extinguisher) if 

other fire hazards or radiation hazards are not present.

− Notify all persons present to vacate the area and have one individual immediately call 

the RSO and fire department (as instructed by RSO).

− Once the fire is out, isolate the area to prevent the spread of possible contamination.

− Survey all persons involved in combating the fire for possible contamination.

− Decontaminate personnel by removing contaminated clothing and flushing 

contaminated skin with lukewarm water, then washing with a mild soap.

− In consultation with the RSO, determine a plan of decontamination and the types of 

protective devices and survey equipment that will be necessary to decontaminate the 

area.

− Allow no one to return to work in the area unless approved by the RSO.

− Cooperate with RSO and RSO staff (e.g., investigation of root cause, provision of 

requested bioassay samples).

− Follow the instructions of the RSO and RSO staff (e.g., decontamination techniques, 

surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

− Supervise decontamination activities.

− If decontamination of personnel was not fully successful, consider inducing 

perspiration by covering the area with plastic. Then wash the affected area again to 

remove any contamination released by the perspiration.

− Consult with fire safety officials to ensure that there are no other possibilities of 

another fire starting.

− Determine cause and needed corrective actions; consider need for bioassays if 

licensed material may have been ingested, inhaled, or absorbed through the skin. 

Document incident.

− If necessary, notify the NRC.
M-8

Fires, Explosions, or Major Emergencies

• Instructions to Workers

− Notify all persons in the area to leave immediately.

− Notify the fire department.

− Notify the RSO and other facility safety personnel.

− Upon arrival of firefighters, inform them where radioactive materials are stored or 

where radionuclides were being used; inform them of the present location of the 

licensed material and the best possible entrance route to the radiation area, as well as 

any precautions to avoid exposure or risk of creating radioactive contamination by use 

of high pressure water, etc.

− Cooperate with RSO/RSO staff (e.g., investigation of root cause, provision of 

requested bioassay samples).

− Allow no one to return to work in the area unless approved by the RSO.

− Follow the instructions of the RSO and RSO staff (e.g., decontamination techniques, 

surveys, provision of bioassay samples, requested documentation).

• Reminders to RSO

− Coordinate activities with facility’s industrial hygienist or environmental health and

safety office, and with local fire department.

− Consult with the firefighting personnel and set up a controlled area where the 

firefighters can be surveyed for contamination of their protective clothing and 

equipment after the fire is extinguished.

− Once the fire is extinguished, do not allow the firefighters to enter the radiation area 

until a thorough evaluation and survey are performed to determine the extent of the 

damage to the licensed material use and storage areas.

− Perform thorough contamination surveys of the firefighters and their equipment before 

they leave the controlled area and decontaminate, if necessary.

− Supervise decontamination activities.

− Consider bioassays if licensed material may have been ingested, inhaled, or absorbed 

through the skin. Document incident.
M-9

− If necessary, notify the NRC.

Copies of emergency procedures should be provided to all users. Post a current copy in each 

laboratory or other area where radioactive material is used.

APPENDIX N

RADIATION SAFETY SURVEY TOPICS

N-1

This appendix provides applicants and licensees with additional information on surveys, 

including training requirements, survey frequency, contamination limits, and bioassays.

Training

Before allowing an individual to perform surveys, the RSO will ensure that he or she has 

sufficient training and experience to perform surveys independently.

Academic training may be in the form of lecture, videotape, or self-study and will cover the 

following subject areas:

• principles and practices of radiation protection

• radioactivity measurements, monitoring techniques, and using instruments

• mathematics and calculations basic using and measuring radioactivity

• biological effects of radiation.

Appropriate on-the-job-training consists of the following:

• Observing authorized personnel using survey equipment, collecting samples, and 

analyzing samples

• Using survey equipment, collecting samples, and analyzing samples under the 

supervision and in the physical presence of an individual authorized to perform surveys

Facilities and Equipment

• To ensure achieving the required sensitivity of measurements, survey samples will be 

analyzed in a low-background area.

• A gamma counter system with a single or multichannel analyzer can be used to count 

samples containing gamma-emitters (e.g., cesium-137, cobalt-60).

• A liquid scintillation or gas-flow proportional counting system can be used to count 

samples containing alpha-emitters, beta-emitters, and gamma-emitters (if efficiency is 

great enough to achieve the required sensitivity for measurements. See Appendix J.

Ambient Radiation Level Surveys

• Dose-rate surveys, at a minimum, should be performed in locations where workers are 

exposed to radiation levels that might result in radiation doses in excess of 10 percent of 

the occupational dose limits or where an individual is working in a dose rate of 

0.025 millisieverts (Sv) (2.5 millirem per hour (mrem/hr)) or more (50 millisieverts per 

year (mSv/year) divided by 2,000 hr/year).
N-2

• 10 CFR 20.1301 requires that the total effective dose equivalent to an individual member 

of the public from the licensed operation does not exceed 1 mSv (0.1 rem) in 1 year and 

the dose in any unrestricted area from external sources does not exceed 0.02 mSv (2 

mrem) in any 1 hour.

The frequency of ambient surveys depends on the quantity and use of radioactive materials, as 

well as the specific protective facilities, equipment, and procedures designed to protect the 

worker and members of the public from external exposure to radiation. While the regulations do 

not specify a specific survey frequency, the licensee is required to ensure that the dose rate 

limits are not exceeded.

Contamination Surveys

Licensees’ contamination surveys should be sufficient to identify areas of contamination that 

might result in doses to workers or to the public. The total contamination (combined removable 

and fixed contamination) should be surveyed using appropriate radiation detection equipment. 

Removable contamination can be detected and measured through a wipe test of the surface, 

which is counted in an appropriate counting instrument, such as a liquid scintillation counter, a 

sodium iodide or germanium gamma counter, or a proportional alpha and beta counter. 

Contamination surveys should be performed:

• to evaluate radioactive contamination that could be present on surfaces of floors, walls, 

laboratory furniture, and equipment

• after any spill or contamination event

• when procedures or processes have changed

• to evaluate the potential contamination of users and the immediate work area, at the end 

of the day or before leaving the area of use, when licensed material is used

• in unrestricted areas at frequencies consistent with the types and quantities of materials 

in use but generally not less frequently than quarterly

• in areas adjacent to restricted areas and in all areas through which licensed materials 

are transferred and temporarily stored before shipment

Contamination Survey Frequency

Personnel should survey for contamination in locations where individuals are working with an 

unsealed form of radioactive material. These surveys should be done at a frequency 

appropriate to the types and quantities of radioactive materials in use. If the activity used is 

greater than or equal to the smallest annual limit on intake (ALI) (for either inhalation or 

ingestion) as identified in 10 CFR Part 20, Appendix B, then documented surveys should be 

performed at least daily and records retained in accordance with 10 CFR 20.2103.
N-3

Table N.1 contains suggested contamination survey frequencies based on ALIs. The 

suggested frequency of surveys is based on the amount of licensed material “in use” at any one 

time at any particular location. If licensed material has not been used for a period of time 

greater than the required survey frequency, then it is considered to be “not in use.”

Table N.1 Suggested Contamination Survey Frequency

< 0.1 ALI ≥ 0.1 ALI < 1.0 ≥ 1.0 ALI

In Use Monthly Weekly Daily

Not in Use Every 6 Months

Contamination in Unrestricted Areas

Contamination found in unrestricted areas should be immediately decontaminated to 

background levels. When it is not possible to get to background levels, the licensee must 

ensure that the amounts do not exceed the contamination levels listed in Table N.2.

Table N.2 provides the maximum acceptable residual levels for equipment. potentially 

contaminated equipment that is to be released for unrestricted use. Additional guidance for 

release of equipment can be found in NUREG-1575, Supplement 1, “Multi-Agency Radiation 

Survey and Assessment of Materials and Equipment Manual (MARSAME).” Table N.2 values 

also may be used as acceptable criteria for contamination in facilities during facilities in 

operation.

A standardized method for smear testing of a relatively uniform area should be used to aid in 

comparing contamination at different times and places. A smear taken from an area of about 

100 square centimeters (cm2

) is acceptable to indicate levels of removable contamination.
N-4

Table N.2 Acceptable Surface Contamination Levels for Equipment 

Nuclidea Averageb, c Maximumb, d Removableb, e

I-125, I-129 1.7 Bq*/100 cm2 

(100 dpm/100 cm2)

5.0 Bq/100 cm2

(300 dpm/100 cm2)

0.3 Bq/100 cm2

(20 dpm/100 cm2)

I-126, I-131, I-133, Sr-90 16.7 Bq/100cm2 (1,000 

dpm/100 cm2)

50.0 Bq/100cm2(3,000 

dpm/100 cm2)

3.3 Bq/100cm2

(200 dpm/100 cm2)

Beta-gamma emitters 

(nuclides with decay 

modes other than alpha 

emission or 

spontaneous fission) 

except Sr-90 and others 

noted above.

83.3 Bq*/100 cm2 (5,000 

dpm/100 cm2)

250 Bq/100 cm2 (15,000 

dpm /100 cm2)

16.7 Bq/100 cm2

(1,000 dpm/100 cm2)

a Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established 

for alpha- and beta-gamma-emitting nuclides should apply independently. b As used in this table, dpm (disintegration per minute) means the rate of emission by radioactive material as 

determined by correcting the counts per minute observed by an appropriate detector for background, 

efficiency, and geometric factors associated with the instrumentation. c Measurements of average contaminant should not be averaged over more than 1 square meter. For objects of 

less surface area, the average should be derived for each such object. d The maximum contamination level applies to an area of not more than 100 cm2

. e The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping 

that area with filter or soft absorbent paper, applying moderate pressure, and assessing the amount of 

radioactive material on the wipe with an appropriate instrument of known efficiency. When removable 

contamination on objects of less surface area is determined, the pertinent levels should be reduced 

proportionally and the entire surface should be wiped.

*1 Bq = 1 disintegration per second

Decommissioning Surveys for Release for Unrestricted Use

When a facility will be closed and released for unrestricted use, the values in Table N.3 provide 

acceptable residual contamination levels, known as “screening values” for building surfaces. To 

the extent practicable facilities should be decontaminated to below these levels (ALARA). 

Surveys should be conducted for both removable contamination (not to exceed 10 percent of 

the values in Table N.3) and for total residual contamination before the facilities or equipment

are released from restricted to unrestricted use, to ensure that they meet the applicable limits.
N-5

Table N.3 Screening Values for Building Surface Contamination 1

Radionuclide Symbol Screening levels for unrestricted release (dpm/100 cm2)

Hydrogen-3 (Tritium) H-3 1.2 x 108

Carbon-14 C-14 3.7 x 106

Sodium-22 Na-22 9.5 x 103

Sulfur-35 S-35 1.3 x 107

Chlorine-36 Cl-36 5.0 x 105

Manganese-54 Mn-54 3.2 x 104

Iron-55 Fe-55 4.5 x 106

Cobalt-57 Co-57 2.1 x 105

Cobalt-60 Co-60 7.1 x 103

Nickel-63 Ni-63 1.8 x 106

Zinc-65 Zn-65 4.8 x 104

Strontium-90 Sr-90 8.7 x 103

Technetium-99 Tc-99 1.3 x 106

Iodine-129 I-129 3.5 x 104

Cesium-137 Cs-137 2.8 x 104

Europium-152 Eu-152 1.3 x 104

Tungsten-181 W-181 1.1 x 106

Iridium-192 Ir-192 7.4 x 104

1 Screening levels are based on the assumption that the fraction of removable surface contamination is equal to 

0.1. For cases when the fraction of removable contamination is undetermined or higher than 0.1, users may 

assume, for screening purposes, that 100 percent of surface contamination is removable; and therefore the 

screening levels should be decreased by a factor of 10. Alternatively, users having site-specific data on the 

fraction of removable contamination (e.g., within 10 percent to 100 percent range) may calculate site-specific 

screening levels using DandD Version 1.

Units are disintegrations per minute per 100 cm2 (dpm/100 cm2

). 1 dpm is equivalent to 

0.0167 becquerel (Bq). The screening values represent surface concentrations of individual 

radionuclides that would be deemed in compliance with the 0.25 mSv (25 mrem in a year 

unrestricted release dose limit in 10 CFR 20.1402, “Radiological criteria for unrestricted use.” 

For radionuclides in a mixture, the “sum of fractions” rule applies; see 10 CFR Part 20, 

Appendix B, Note 4 for an example of the “sum of fractions” calculation. Refer to NUREG-1757,

“Consolidated Decommissioning Guidance,” for further information on application of the values 

in this table. 

Table N.3 was derived using the DandD screening code, Version 1, (DandD v1.0) and its default 

input parameters. Table N.3 provides criteria that permit licensees to demonstrate compliance 

with the unrestricted release dose criterion in the License Termination Rule in Subpart E of 

10 CFR Part 20. Sites with building surface contamination levels below those listed in 

Table N.3 would be deemed acceptable for release for unrestricted use in accordance with the 

dose criteria in 10 CFR 20.1402, provided that residual radioactivity has been reduced to 

ALARA levels. The table is intended for use as criteria to facilitate license termination for many 

simple routine decommissioning cases without a site-specific dose assessment. For facilities 

with contamination levels above those in Table N.3, additional site-specific dose assessments 

may be necessary, and licensees should refer to NUREG-1757 regarding acceptable methods 

for conducting the appropriate dose assessment, such as using DandD v2.1 to develop sitespecific screening criteria. The most recent version of the DandD code can be installed by 

downloading the self-extracting program file, setup.exe, accessed through the Web site: 
N-6

http://www.marssim.com/Dose_Modeling.htm. Links to other useful software and guidance 

documents are also found at that web site.

Table N.3 does not include screening values for radionuclides that emit alpha particles, or for 

soil contamination. Screening values for radionuclides not listed above may be found in 

“Supplemental Information on the Implementation of the Final Rule on Radiological Criteria for 

License Termination,” in the Federal Register 63 FR 64132 (November 18, 1998) (for building 

surfaces); “Supplemental Information on the Implementation of the Final Rule on Radiological 

Criteria for License Termination” 64 FR68395 (December 7, 1999)(for soils); and “Use of 

Screening Values to Demonstrate Compliance With the Final Rule on Radiological Criteria for 

License Termination” (65 FR 37186 (June 13, 2000). ) (which references Tables 5.19 (surface 

contamination) and 6.91 (surface soil) from NUREG/CR–5512, Vol. 3, “Residual Radioactive 

Contamination from Decommissioning, Parameter Analysis, Draft Report for Comment, October 

1999,””).

Tables 5.19 (surface contamination) and 6.91 (surface soil for use in determining acceptable 

screening values are for radionuclides not listed in the first two Federal Register notices.

Survey Record Requirements

Each survey record should include the following:

• a diagram of the area surveyed (see Figure N.1)

• a list of items and equipment surveyed

• specific locations on the survey diagram where wipe test was taken

• ambient radiation levels with appropriate units

• contamination levels with appropriate units

• make and model number of instruments used

• background levels

• name of the person making the evaluation and recording the results and date

Licensees should record contamination levels observed and procedures followed for incidents 

involving contamination of individuals. The record should include names of individuals involved, 

description of work activities, calculated dose, probable causes (including root causes), steps 

taken to reduce future incidents of contamination, times and dates, and the surveyor’s 

signature.

The type of surveys to be performed for decommissioning of facilities, and the number and 

locations of survey points or samples to be collected, should be determined using guidance 

found in NUREG-1757, “Consolidated Decommissioning Guidance.” Most ARDL licensees will 

be able to use the “Simple Approaches for Conducting Final Radiological Surveys” found in 

Appendix B of NUREG-1757, Volume 2. If the decommissioning of a facility is too complex to 

allow use one of the “simple approaches,” then a licensee may have to develop a more formal 

decommissioning plan.
N-7

Figure N.1 Laboratory Layout

This is an example of a laboratory survey map.

Air Monitoring in the Workplace

Air sampling can be used to do the following:

• determine whether the confinement of radioactive materials is effective

• measure airborne radioactive material concentrations in the workplace

• estimate worker intakes of radioactive material

• determine posting requirements

• determine what protective equipment and measures are appropriate

• warn of significantly elevated levels of airborne radioactive materials

If bioassay measurements are used to determine worker doses of record, air sampling may be 

used to determine time of intake and to determine which workers should have bioassay 

measurements. The use of engineering controls and a good air sampling program may 

eliminate need for bioassays.

Refer to Regulatory Guide 8.25, Revision 1, “Air Sampling in the Workplace,” dated June 1992 

and NUREG-1400, “Air Sampling in the Workplace,” dated September 1993, for further 
N-8

guidance on the air sampling. NUREG-1400 is available in ADAMS at Accession 

No. ML102371083.

Airborne Effluent Release Monitoring

When practicable, airborne radioactive effluents should be released from monitored release 

points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to 

estimate public exposure. Licensees should verify the performance of effluent monitoring 

systems by regular calibration (at least annually) to ensure their reliability. Regulatory 

Guide 4.20, Revision 1, “Constraints on Releases of Airborne Radioactive Materials to the 

Environment for Licensees Other than Power Reactors,” Revision 1, issued April 2012, provides 

guidance on methods (calculation or COMPLY code) acceptable to the NRC for compliance with 

the constraint on air emissions to the environment.

Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” issued July 1993, 

provides guidance on designing an acceptable program for establishing and maintaining ALARA 

levels for gaseous and liquid effluents at materials facilities.

For release points where monitoring is not practicable, the licensee should estimate the 

magnitude of the unmonitored effluents. These unmonitored releases will occur any time 

unsealed material is handled outside a fume hood or other device that will control the releases. 

The licensee should include these estimates when demonstrating compliance with dose limits 

and ALARA goals. Unmonitored releases may be estimated based on the quantity of material 

used in these areas or the number of procedures performed or other appropriate methods. The 

unmonitored effluents should not exceed 30 percent of the total estimated effluent releases or 

10 percent of the permissible air effluent concentrations found on column 1 of Table 2 in 

10 CFR Part 20, Appendix B, whichever is greater.

Effluent monitoring systems should be designed in accordance with ANSI N13.1 (N13.1-2011), 

“Sampling and Monitoring Releases of Airborne Radioactive Substances from the Stacks and 

Ducts of Nuclear Facilities,” and ANSI N42.18-1991, “Specification and Performance of On-site 

Instrumentation for Continuously Monitoring Radioactive Effluents.”

Liquid Effluent Release Monitoring

• The licensee should evaluate the concentrations of radioactive material in water that is 

released to the environment and to the sanitary sewer. The licensee must show that 

these releases meet the limits in 10 CFR 20.1301 and 20.2003, respectively.

The topic of sanitary sewerage releases is more fully discussed in Appendix Q.

Bioassay Monitoring

Frequency of Required Bioassay Measurements

Determining the appropriate frequency of routine bioassay measurements depends on the 

exposure potential and the physical and chemical characteristics of the radioactive material and 

the route of entry to the body. Consider the following elements:
N-9

• potential exposure of the individual

• retention and excretion characteristics of the radionuclides

• sensitivity of the measurement technique

• acceptable uncertainty in the estimate of intake and committed dose equivalent

Bioassay measurements used for demonstrating compliance with the occupational dose limits 

should be conducted often enough to identify and quantify potential exposures and resultant 

intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10 percent 

ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes 

and assess occupational doses for exposed individuals who are likely to exceed 10 percent of 

the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults).

Separate categories of bioassay measurements, routine measurements, and special 

measurements further determine the frequency and scope of measurements.

Routine Bioassay Measurements

Routine bioassay measurements include baseline measurements, periodic measurements, and 

termination measurements. These measurements should be conducted to confirm that 

appropriate controls exist and to assess dose. The method of bioassay selected (e.g., whole 

body counting, urinalysis) and the samples collected will vary according to the radionuclide and 

the compound to which it is attached. Sample collection procedures should be developed to 

ensure that appropriate types, sizes, and numbers of samples are collected that will provide 

appropriate physiological information for the dose assessment.

An individual’s baseline measurement of radioactive material within the body should be 

conducted before beginning work that involves exposure to radiation or radioactive materials for 

which monitoring is required.

In addition to the baseline measurements, periodic bioassay measurements should be 

performed. The frequency of periodic measurements should be based on the likelihood of 

significant exposure of the individual. In determining the worker’s likely exposure, consider such 

information as the worker’s access, work practices, measured levels of airborne radioactive 

material, and exposure time. Periodic measurements should be made when the cumulative 

exposure to airborne radioactivity, since the most recent bioassay measurement, is > 0.02 ALI 

(40 derived air concentration (DAC) hours). Noble gases and airborne particulates with a 

radioactive half-life of less than 2 hours should be excluded from the evaluation, since external 

exposure generally controls these radionuclides.

At a minimum, periodic measurements should be conducted annually. Periodic measurements 

provide additional information on any long-term accumulation and retention of radioactive 

material in the body, especially for exposures to concentrations of airborne radioactive material 

below monitoring thresholds.

When an individual is no longer subject to the bioassay program, because of change in 

employment status, termination bioassay measurement should be made, when practicable, to 

ensure that any unknown intakes are quantified.
N-10

Special Bioassay Monitoring

Because of uncertainty in the time of intakes and the absence of other data related to the 

exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to 

actual intakes for routine measurements sometimes can be difficult. Abnormal and inadvertent 

intakes from situations such as a failed respiratory protective device, inadequate engineering 

controls, inadvertent ingestion, contamination of a wound, or skin absorption, should be 

evaluated on a case-by-case basis. When determining whether potential intakes should be 

evaluated, consider the following circumstances:

• the presence of unusually high levels of facial or nasal contamination

• entry into airborne radioactivity areas without appropriate exposure controls

• operational events with a reasonable likelihood that a worker was exposed to unknown 

quantities of airborne radioactive material (e.g., loss of system or container integrity)

• known or suspected incidents of a worker ingesting radioactive material

• incidents that result in contamination of wounds or other skin absorption

• evidence of damage to or failure of a respiratory protective device

References: The following reference documents may be found on the NRC’s public web site 

under “Document Collections” or in the ADAMS Public Library using the Accession No.:

• NUREG-1549, “Decision Methods for Dose Assessment to Comply with Radiological 

Criteria for License Termination,” July 1998, ADAMS Accession No. ML993250291.

• NUREG-1575, “Multi-Agency Radiation Survey and Site Investigation Manual 

(MARSSIM),” Revision 1, August 2000.

• NUREG-1575, Supplement 1, “Multi-Agency Radiation Survey and Assessment of 

Materials and Equipment Manual (MARSAME).”

• NUREG-1757, “Consolidated Decommissioning Guidance,”

o Volume 1, Decommissioning Process for Materials Licensees (Revision 2), 

September 2006.

o Volume 2, Characterization, Survey, and Determination of Radiological Criteria 

(Revision 1), September 2006.

• NUREG/CR-5512, Volume 2, “Residual Radioactive Contamination from 

Decommissioning User’s Manual DandD Version 2.1,” April 2001, ADAMS Accession 

No. ML010940257.

• NUREG/CR–5512, Volume 3, “Residual Radioactive Contamination from 

Decommissioning, Parameter Analysis, (Draft Report for Comment), October 1999” 
N-11

[containing Tables 5.19 (surface contamination) and 6.91 (surface soil)], ADAMS 

Accession No. ML082460902.

• NUREG-1400, “Air Sampling in the Workplace,” September 1993, ADAMS Accession 

No. ML13051A671.

• Federal Register “Supplemental Information on the Implementation of the Final Rule on 

Radiological Criteria for License Termination,” 63 FR 67132-34 (November 18, 

1998).Federal Register . “Supplemental Information on the Implementation of the Final 

Rule on Radiological Criteria for License Termination,”, 64 FR 68395–96 (December 7, 

1999).

• Federal Register, “Use of Screening Values to Demonstrate Compliance With the Final 

Rule on Radiological Criteria for License Termination,” (65 FR 37186 (June 13, 2000).

• Regulatory Guide 4.20, “Constraints on Release of Airborne Radioactive Materials to the 

Environment for Licensees other than Power Reactors,” Revision 1, April 2012.

• Regulatory Guide 8.9, “Acceptable Concepts, Models, Equations, and Assumptions for a 

Bioassay Program,” Revision 1, July 1993.

• Regulatory Guide 8.20, “Applications of Bioassay for I-125 and I-131, September 1979,” 

(Note: DG-8050, “Applications of Bioassay for I-125 and I-131” (ADAMS Accession 

No. ML102800439)), Revision 1, September 2011, ADAMS at Accession 

No. ML102800439.)

• Regulatory Guide 8.23, “Radiation Safety Surveys at Medical Institutions,” Revision 1,

January 1981.

• Regulatory Guide 8.25, “Air Sampling in the Workplace,” Revision 1, June 1992.

• Regulatory Guide 8.32, “Criteria for Establishing a Tritium Bioassay Program,” 

July 1988.

• Regulatory Guide 8.34, “Monitoring Criteria and Methods to Calculate Occupational 

Doses,” July 1992.

• Regulatory Guide 8.37, “ALARA Levels for Effluents from Materials Facilities,” July 1993.

• NUREG-1400, “Air Sampling in the Workplace,” September 1993, ADAMS Accession 

No. ML13051A671.

• ANSI N13.1 (N13.1-2011), “Sampling and Monitoring Releases of Airborne Radioactive 

Substances from the Stacks and Ducts of Nuclear Facilities.”

• ANSI N42.18 (N42.18-1991), “Specification and Performance of On-site Instrumentation 

for Continuously Monitoring Radioactive Effluents,” 1991.
N-12

• NCRP Commentary No. 3, “Screening Techniques for Determining Compliance with 

Environmental Standards,” published in January 1989, and the addendum published in 

October 1989.
APPENDIX O

MODEL LEAK TEST PROCEDURES

O-1

This appendix provides applicants and licensees with model leak test procedures and sample 

calculations for determining activity on a wipe test sample.

Training

Before allowing an individual to perform leak testing, the licensee must ensure that he or she

has sufficient classroom and on-the-job training to show competency in performing leak tests

independently.

Classroom training may be in the form of lecture, online, video, or self-study, and should cover

the following subject areas:

• principles and practices of radiation protection

• radioactivity measurements, monitoring techniques, and using instruments

• mathematics and calculations used for measuring radioactivity

• biological effects of radiation

Appropriate on-the-job-training consists of the following:

• observing authorized personnel collecting and analyzing leak test samples

• collecting and analyzing leak test samples under the supervision and in the physical

presence of an individual authorized to perform leak tests

Facilities and Equipment

• To ensure achieving the required sensitivity of measurements, analyze leak tests in a

low-background area.

• Use a calibrated and operable survey instrument to check leak test samples for gross

contamination before they are analyzed.

• Analyze the leak test sample using an instrument that is appropriate for the type of

radiation to be measured (e.g., NaI (Tl) well-counter system for gamma-emitters; liquid

scintillation for beta-emitters; gas-flow proportional counters for alpha-emitters).

• If the sensitivity of the counting system is unknown, the minimum detectable activity

(MDA) should be determined. The MDA may be determined using the following formula:

MDA = 2.71 + 4.65 √(bkg x t) = Minimum Detectable Activity

t x 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
O-2

For example, where: bkg = 200 counts per minute (cpm)

E = 0.1 counts per disintegration (10% efficient)

t = 2 minutes

MDA = 2.71 + 4.65 √(200 cpm × 2 minutes) = 2.71 + 4.65√(400)

 2 × 0.1 0.2

 = 2.71 + 4.65 (20) = 2.71 + 93 = 95.71

 0.2 0.2 0.2

 = 478.55 disintegrations

 minute 

 becquerels (Bq) = 1 disintegration

 second

 Bq = 478.55 disintegration × minute = 7.976 Bq

 minutes 60 seconds

Frequency for Conducting Leak Tests of Sealed Sources

Leak tests shall be conducted every 6 months, or at the frequency specified in the respective 

SSD registration certificate.

Procedure for Performing Leak Testing and Analysis

For each source to be tested, list identifying information such as manufacturer, model number, 

serial number, radionuclides, and activity.

• If available, use a survey meter to monitor exposure.

• Prepare a separate wipe sample (e.g., cotton swab or filter paper) for each source.

• Number each wipe to correlate with identifying information for each source.

• Wipe the most accessible area (but not directly from the surface of a source) where 

contamination would accumulate if the sealed source were leaking.

• Select an instrument that is sensitive enough to detect 185 becquerels (Bq)

(0.005 microcurie) of the radionuclides and ensure that its calibration is current.

• Using the selected instrument, count and record background count rate.

• Check the counting efficiency of the instrument using a standard source of the same

radionuclide as that of the source being tested or one with similar energy characteristics.

Accuracy of standards should be within plus or minus 5 percent of the stated value and

traceable to primary radiation standards such as those maintained by the National Institute of 

Standards and Technology.
O-3

• Calculate efficiency.

For example: [(cpm from std) - (cpm from bkg)]

activity of std in Bq

= efficiency in cpm/Bq

where: cpm = counts per minute

std = standard

bkg = background

Bq = becquerel

• Count each wipe sample; determine net count rate.

• For each sample, calculate and record estimated activity in Bq (or millicuries).

For example: [(cpm from wipe sample) - (cpm from bkg)]

efficiency in cpm/Bq

= Bq on wipe sample

• Sign and date the list of sources, data, and calculations. Retain records for 3 years (as 

required by10 CFR 20.2103(a)). If the wipe test activity is 185 Bq (0.005 microcurie) or 

greater, notify the RSO so that the source can be withdrawn from use and disposed of 

properly. Also notify the NRC.

APPENDIX P

TRANSPORTATION REQUIREMENTS

P-1

Note: The reference charts included at the end of this appendix are for reference only and are 

not a substitute for DOT and NRC transportation regulations.

The following are the major areas in U.S. Department of Transportation (DOT) regulations most 

relevant for shipping and transporting Type B quantities of radioactive material:

A. Table of Hazardous Materials and Special Provisions—49 CFR 172.101

1. Title 49 of the Code of Federal Regulations (49 CFR) 172.101—Purpose and Use of 

Hazardous Materials Table

B. Shipping Papers

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 (if applicable)

C. Package Markings

1. 49 CFR 172.301—General Marking Requirements for Non-Bulk Packages

2. 49 CFR 172.304—Marking Requirements

3. 49 CFR 172.310—Class 7 (radioactive) Materials

4. 49 CFR 172.324—Hazardous Substances in Non-bulk Packaging (designation of 

“reportable quantities” with the letters “RQ”)

D. Package Labeling

1. 49 CFR 172.400(a)—General Labeling Requirements

2. 49 CFR 172.403—Class 7 (radioactive) Material

3. 49 CFR 172.406—Placement of Labels

E. Placarding of Vehicles

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

F. Emergency Response Information

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

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

1. 49 CFR 172.800—Purpose and Applicability

2. 49 CFR 172.802—Components of a Security Program

I. Shippers—General Requirements for Shipments and Packaging
P-2

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 173.441—Radiation Level Limitations and Exclusive Use Provisions

6. 49 CFR 173.471—Requirements for U.S. Nuclear Regulatory Commission approved 

packages

7. 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

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)

Applicants should visit the U.S. Department of Transportation Web site for additional information 

on transportation requirements: http://www.dot.gov/.
P-3
P-4
P-5
P-6
P-7
P-8
P-9
P-10
APPENDIX Q

MODEL WASTE MANAGEMENT PROCEDURES

Q-1

General Guidelines

• All radioactivity labels must be defaced or removed from containers and packages 

before disposal in ordinary (nonradioactive) waste. If waste is compacted, all labels that 

are visible in the compacted mass must be defaced or removed.

• Remind workers that nonradioactive waste such as leftover reagents, boxes, and 

packaging material should not be mixed with radioactive waste.

• Occasionally monitor all procedures to ensure that radioactive waste is not created

unnecessarily. Review all new procedures to ensure that waste is handled in a manner 

consistent with established procedures.

• In all cases, consider the entire effect of various available disposal routes. Consider 

occupational and public exposure to radiation, other hazards associated with the 

material and routes of disposal (e.g., toxicity, carcinogenicity, pathogenicity, 

flammability), and costs.

• The waste management program should include waste handling procedures for the 

users within their laboratories or assigned areas, and for waste handlers that may collect 

waste from areas of use to bring to the storage area for eventual disposal.

• Housekeeping staff should be provided adequate training to avoid the possibility of 

unauthorized disposal or exposure of these individuals to radioactive materials or to 

radiation.

Model Procedure for Disposal by Decay-in-Storage 

• Only short-lived waste (physical half-life of less than or equal to 120 days) may be 

disposed of by decay-in-storage (DIS).

• Short-lived waste should be segregated from long-lived waste (half-life greater than 

120 days) at the source.

• Waste should be stored in suitable well-marked containers, and the containers should 

provide adequate shielding.

• Liquid and solid wastes must be stored separately.

• When the container is full, it should be sealed. The sealed container should be identified 

with a label affixed or attached to it.

• The identification label should include the date when the container was sealed, the 

radionuclide(s) in the container and estimated amounts, and the initials of the individual 

who sealed the container. The container may be transferred to the DIS area.

• The contents of the container should be allowed to decay for a period of time after which 

it is expected that the radiation levels would not be distinguishable from background. 
Q-2

The period of time depends on both the half-live of the radionuclide(s) and the original 

amount present.

• Before disposal as ordinary trash, each container should be monitored with an 

appropriate radiation detection instrument, on the lowest setting, as follows:

− Check the radiation detection survey meter for proper operation.

− Survey the contents of each container in a low background area.

− Remove any shielding from around the container.

− Monitor all surfaces of the container.

− Discard the contents as ordinary trash only if the surveys of the contents indicate no 

residual radioactivity (i.e., surface readings are indistinguishable from background).

− If the surveys indicate residual radioactivity, return the container to DIS area and 

contact the RSO for further instructions.

• If the surveys indicate no residual radioactivity, record the date when the container was 

sealed, the disposal date, type of waste (used or unused material, gloves, etc.), survey 

instrument used, and the initials of the individual performing surveys and disposing of 

the waste.

In accordance with 10 CFR 20.1904(b), all radiation labels must be defaced or removed 

from containers and packages before disposal as ordinary trash. Syringes and needles 

placed into sealed waste containers for decay do not need the labels removed, provided 

that the following is done: waste barrels are sealed before delivery to the waste disposal

firm and delivered directly from the licensee’s facility; labels are removed from the waste 

barrels or containers; the waste is incinerated, not placed in a landfill; and the waste 

disposal firm is cautioned not to open the container before incineration.

Model Procedure for Disposal of Liquids into Sanitary Sewerage

• Confirm that the sewerage system is a public system, not a private sewerage system, 

septic system, or leach field.

• Confirm that the liquid waste being discharged is either soluble material, or a biological 

material that is readily dispersible in water.

• Calculate the amount of each radionuclide that can be discharged by using the 

information from previous, similar discharges and the information in 10 CFR Part 20,

Appendix B.

• Make sure that the amount of each radionuclide does not exceed the monthly and 

annual discharge limits specified in 10 CFR 20.2003(a)(4) and in Appendix B to 

10 CFR Part 20.
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• Record the date, radionuclide(s), estimated activity of each radionuclide, location where 

the material is discharged, and the initials of the individual discharging the waste.

• Liquid waste should be discharged only through designated sinks, toilets, or release 

points.

• Discharge liquid waste slowly with water running from the faucet to dilute it.

• Survey the sink and surrounding work surfaces to confirm that no residual material or 

contamination remained in the sink or on work surfaces.

• Before leaving the area, decontaminate all areas or surfaces, if found to be 

contaminated.

• Maintain records of each radionuclide and its quantity and concentration that is released 

into the sanitary sewer system.

Model Procedure for Compaction

The following information should be provided from licensees that propose to compact waste.

(1) Describe the compactor to demonstrate that it is adequately designed and manufactured 

to safely compact the type and quantity of waste generated during licensed operations 

(e.g., provide manufacturer’s specifications, annotated sketches, photographs).

(2) Describe the type, quantities, and concentrations of waste to be compacted.

(3) Provide an analysis of the potential for airborne release of radioactive material during 

compaction activities.

(4) State the location of the compactor(s) within the waste processing area(s), and provide a 

description of the ventilation and filtering systems used in conjunction with the 

compactors. Include a description of the procedures for monitoring filter blockage and 

exchange.

(5) Discuss the methods used to monitor worker breathing zones and exhaust systems.

(6) Discuss the types and frequencies of surveys that will be performed for contamination 

control in the compactor area.

(7) Describe the instruction provided to compactor operators, including instructions for 

protective clothing, checks for proper functioning of equipment, method of handling 

uncompacted waste, and instruction for examining containers for defects

APPENDIX R

INTERIM STAFF GUIDANCE ON CONSTRUCTION

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INTERIM STAFF GUIDANCE TO NUREG-1556 AND NUREG-1520: 

COMMENCEMENT OF CONSTRUCTION AT EXISTING AND PROPOSED SOURCE, 

BYPRODUCT, AND SPECIAL NUCLEAR MATERIAL FACILITIES AND IRRADIATORS WITH 

SIGNIFICANT ENVIRONMENTAL IMPACTS

PURPOSE AND SCOPE

This Interim Staff Guidance (ISG) provides guidance to U.S. Nuclear Regulatory Commission 

(NRC) staff on the new definition of construction and the consideration of activities that can be 

performed by materials license applicants and potential applicants (hereinafter collectively 

referred to as “applicants”), and licensees before the NRC staff has concluded its environmental 

review of the proposed licensing action.

This ISG applies to the review of licensing actions related to the receipt and possession of 

licensable source, byproduct, and special nuclear material (SNM) for the conduct of any activity 

which the NRC determines will significantly affect the quality of the environment. This ISG is 

intended to provide guidance to NRC staff but may also be instructive to all holders of operating 

licenses for source, byproduct, and SNM facilities and irradiators, and all persons that have 

submitted applications to construct source, byproduct, and SNM facilities or irradiators, or have 

submitted letters of intent to submit such applications under Title 10 of the Code of Federal 

Regulations (10 CFR) Parts 30, 36, 40, and 70.

This ISG applies to all Part 30, 36, 40 and 70 materials facilities other than uranium recovery 

facilities. Site preparation activities at uranium recovery facilities are addressed in Regulatory 

Issue Summary 2009-12, Uranium Recovery Policy Regarding Site Preparation Activities at 

Proposed, Unlicensed Uranium Recovery Facilities, September 23, 2009, ML092090353. 

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. In accordance with 10 CFR 36.15, commencement of 

construction of an irradiator will only be grounds for denial if the licensee or applicant has not 

submitted both an application and the requisite licensing fee. 

BACKGROUND

The NRC amended its regulations in September 2011, by revising certain provisions applicable 

to the licensing and approval processes for byproduct, source and SNMs licenses, and 

irradiators 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” with respect to materials licensing actions conducted 
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under the NRC's regulations. The NRC adopted these changes to further improve the 

effectiveness and efficiency of the licensing and approval processes for future materials license 

applications, as well as to eliminate certain inconsistencies that existed within the NRC's 

regulations with respect to the use and definition of the terms “construction” or “commencement 

of construction” for certain materials licensees for purposes of its environmental reviews.

The new 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.

In 10 CFR 150.31, 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 radiological health and safety. The regulations in 10 CFR 

150.31 address the requirement for Agreement State regulation of byproduct material. Although 

Agreement State licensees may find this ISG informative, they should also communicate with 

the pertinent Agreement State agency for that agency’s applicable requirements and guidance.

The new definitions of “construction” in 10 CFR 30.4, 36.2, and 70.4 are also 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
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(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.

This guidance provides criteria for NRC staff to use in evaluating 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 revised definition of construction 

in 10 CFR 30.4, 36.2, 40.4, 70.4, and 150.31 list activities that are not considered “construction.”

This guidance provides examples of activities that fall under each of the excepted activities that 

do not constitute construction. This guidance addresses some important considerations for 

materials licensees and applicants that were emphasized in the response to comments on the 

proposed Material Licenses Construction Rule. For example, 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 SOC to 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.
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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 

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.
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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 

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 currently 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, soil compaction.
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• 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, 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.

• 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 
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mechanical adequacy of systems for moving shipping containers into and out of the pool 

area.

URANIUM CONVERSION FACILITIES, ENRICHMENT FACILITIES, FUEL FABRICATION 

FACILITIES, AND URANIUM HEXAFLUORIDE (UF6) DECONVERSION FACILITIES (10 CFR 

PART 40 and 10 CFR PART 70)

If any of the following actions are performed before the NRC staff has completed its 

environmental review process, then the NRC has grounds for denial of a license application, in 

accordance with 10 CFR 40.32(e), and 70.23(a)(7):

1. Procurement or construction of engineered items that are items relied on for safety 

(IROFS) required to meet the performance requirements of 10 CFR 70.61.

2. Construction of guard stations, fences, vehicle barriers, or other features that are, or will 

become, components of physical security systems required by regulations or orders.

3. Construction or installation of equipment whose purpose is the detection of radioactive 

material accidents or mitigation of the consequences of radioactive material accidents.

4. Installation of storage tanks that contain chemicals that could affect the safety of 

licensed material. 

5. Construction of facilities or warehouses that will be used for operations involving 

licensed material.

6. Driving of piles; subsurface preparation; placement of backfill, concrete, or permanent 

retaining walls within an excavation; installation of foundations; or in-place assembly, 

erection, fabrication, or testing, which are for IROFS and on-site emergency facilities.

7. Erection of buildings, offices, construction trailers and warehouses that will become part 

of a Standard Practice Procedures Plan for Protection of Classified Information.

Construction includes the onsite, in-place fabrication, erection, integration, or testing activities 

for any safety related item. The terms “onsite, in place, fabrication, erection, integration, or 

testing” describe the process of constructing a fuel cycle facility in its final, onsite plant location, 

where components or modules are integrated into the final, in-plant location. Under the 

definition of “construction” applicants and existing licensees may be able to fabricate, assemble, 

and test components and modules in a shop building, warehouse, or laydown area, even if 

these facilities are located onsite. However, the installation or integration of that safety related 

equipment into its final plant location is a construction activity and should not be performed until 

after the NRC staff concludes its environmental review of the license application.

Excavation includes the removal of any soil, rock, gravel, or other material below the final 

ground elevation to the final parent material, and may be conducted prior to the conclusion of 

the NRC staff’s environmental review. However, placing permanent, nonstructural dewatering 

materials, mudmats, or engineered backfill in advance of placing the foundation and associated 

permanent retaining walls for buildings or structures that will contain licensed materials are 

construction activities and should not be performed prior to the conclusion of the NRC staff’s 

environmental review.

Construction includes driving piles for buildings or structures that will contain licensed materials. 

Hence the driving of piles for such buildings or structures should not be performed before the 

NRC staff concludes its environmental review. Driving piles that do not ensure the structural 
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stability or integrity of buildings or structures within the scope of the definition of “construction” 

(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 conclusion of the NRC 

staff’s environmental review.

In addition to 10 CFR 40.4, 51.4, and 70.4 criteria that are used to determine the scope of 

activities that fall within the definition of construction, construction includes the necessary 

excavation for safety related items. A necessary excavation is the portion of an excavation that 

provides sufficient construction access to the structures that are within the definition of 

construction. Applicants should ensure, and NRC staff will confirm, that these construction 

activities are separate from, and do not result in, adverse interactions with construction-related 

safety related item including influence on the stability (static and dynamic) analyses.

Construction includes any change made to the parent material in which the excavation occurs 

(e.g., soil compaction, rock grouting); the driving of piles; the installation of foundations; 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; and the installation of reinforcing 

bars to be incorporated into the foundation of any safety related items that fall within the 

definition of construction. The foregoing items fall within the definition of construction because 

they have 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 from radiological hazards.

ACTIVITIES WHICH HAVE NO REASONABLE NEXUS TO RADIOLOGICAL SAFETY OR 

SECURITY

The NRC has determined that, in general, the following activities at source, byproduct, and SNM 

facilities and irradiators 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 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;
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(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. 

FINAL RESOLUTION

This interim staff guidance will be incorporated into the next revisions of NUREG-1556, and 

NUREG-1520.

APPLICABILITY

This ISG is applicable to all 10 CFR Parts 30, 36, 40, and 70 license applicants and existing 

licensees considering site preparation activities or construction activities at a facility that is 

subject to, or will be subject to, the licensing requirements of these parts.

REFERENCES 

1) NUREG-1556, Volume 6, “Consolidated Guidance About Material Facilities: Program-

 Specific Guidance About 10 CFR Part 36 Irradiator Licenses,” January 1999.

2) NUREG-1556, Volume 12, “Consolidated Guidance About Materials Licenses: Program

 Specific Guidance About Possession Licenses for Manufacturing and Distribution,”

 December 2000.

3) NUREG-1520, “Standard Review Plan for the Review of a License Application for a Fuel

Cycle Facility,” Revision 1, May 2010.

4) Regulatory Issue Summary 2009-12, Uranium Recovery Policy Regarding Site Preparation

Activities at Proposed, Unlicensed Uranium Recovery Facilities, September 23, 2009,

ML092090353.

5) NUREG-1748, “Environmental Review Guidance for Licensing Actions Associated with

Materials Facilities,” August 2003.

6) DC/COL-ISG-4, “Interim Staff Guidance on the Definition of Construction and on Limited 

Work Authorizations,” February 9, 2009, ML082970729. 

7) Inspection Manual Chapter 2815, “Construction and Preoperational Inspection of Panoramic

Wet-Source-Storage Gamma Irradiators,” March 27, 2001, ML010990225. 

8) Docket No. 030-36974, Final Environmental Assessment Related to the Proposed Pa’ina

Hawaii, LLC, Underwater Irradiator in Honolulu, Hawaii; August 10, 2007; ML071150121.

9) Docket No. 70-7015, Environmental Assessment for an Exemption to 10 CFR Parts 30, 40,

and 70, Commencement of Construction Requirements, Areva Enrichment Services, Eagle

Rock Enrichment Facility, Bonneville County, Idaho, February 28, 2010, ML093220528.
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10) NUREG-1811, “Environmental Impact Statement for an Early Site Permit at the North Anna

ESP Site,” December 2006.

11) NUREG-1947, “Final Supplemental Environmental Impact Statement for Combined License

(COLs) for Vogtle Electric Generating Plant Unit 3 and 4,” March 2011.

Technical Contact: Mary T. Adams

301-492-3113

E-mail: Mary.Adams@nrc.gov
APPENDIX S

SAFETY CULTURE STATEMENT OF POLICY 

S-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: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-

14656.pdf. It is also posted in the NRC’s Agencywide Documents Access and Management 

System (ADAMS) and can be found using Accession Number 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.
S-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.



UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, DC 20555-0001

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OFFICIAL BUSINESS
 

 

NUREG-1556, Vol. 7

Revision 1, Draft

Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 

Academic, Research and Development, and Other Licenses of Limited Scope