Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

Master Materials Licenses

Final Report

Office of Nuclear Material Safety and Safeguards

NUREG-1556

Volume 10, Rev. 1 
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Consolidated Guidance 

About Materials Licenses

Program-Specific Guidance About 

Master Materials Licenses

Final Report

Manuscript Completed: May 2016

Date Published: June 2016

Prepared by: 

R. Browder

J. Cook

R. Elliott

R. Johnson

O. Masnyk Bailey

K. G. Null

S. W. Seeley

S. S. Xu

Office of Nuclear Material Safety and Safeguards

 

NUREG-1556

Volume 10, Rev. 1 

iii 

ABSTRACT 

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

existing Master Materials Licenses to assist licensees who apply for amendments to their 

licenses and assist Federal agencies in preparing new applications for a Master Materials 

License. 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 NRC license reviewers in implementing the 

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

whether the proposed activities are acceptable for licensing purposes. 

Paperwork Reduction Act Statement 

The information collections contained in this NUREG are covered by the requirements of 

NRC Form 313 and were approved by the Office of Management and Budget (OMB), approval 

number 3150-0120. 

Public Protection Notification 

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

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

currently valid OMB control number. 

v 

FOREWORD 

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

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

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

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

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

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

Volume No. Volume Title 

1 Program-Specific Guidance about Portable Gauge Licenses 

2 Program-Specific Guidance about Industrial Radiography Licenses 

3 Applications for Sealed Source and Device Evaluation and Registration 

4 Program-Specific Guidance about Fixed Gauge Licenses 

5 Program-Specific Guidance about Self-Shielded Irradiator Licenses 

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

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

Other Licenses of Limited Scope Including Electron Capture Devices and 

X-Ray Fluorescense Analyzers 

8 Program-Specific Guidance about Exempt Distribution Licenses 

9 Program-Specific Guidance about Medical Use Licenses 

10 Program-Specific Guidance about Master Materials Licenses 

11 Program-Specific Guidance about Licenses of Broad Scope 

12 Program-Specific Guidance about Possession Licenses for Manufacturing 

and Distribution 

13 Program-Specific Guidance about Commercial Radiopharmacy Licenses 

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

Study Licenses 

15 Guidance about Changes of Control and about Bankruptcy Involving 

Byproduct, Source, or Special Nuclear Materials Licenses 

16 Program-Specific Guidance about Licenses Authorizing Distribution to 

General Licensees 

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

Critical Mass Licenses 

18 Program-Specific Guidance about Service Provider Licenses 

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

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

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

to Work in Agreement State Jurisdiction (Reciprocity) 

20 Guidance about Administrative Licensing Procedures 

21 Program-Specific Guidance about Possession Licenses for Production of 

Radioactive Materials Using an Accelerator 

The current document, NUREG–1556, Volume 10, Revision 1, “Consolidated Guidance About 

Materials Licenses: Program-Specific Guidance about Master Materials Licenses,” is intended 

for use by applicants, licensees, and NRC staff. This revision provides a general update to the 

previous information contained in NUREG–1556, Volume 10, issued December 2000. 
vi 

This document provides guidance to Federal organizations preparing a Master Materials 

License (MML) application and Federal organizations that have MMLs if applying for a license 

amendment. In addition, it provides the criteria NRC license reviewers and other NRC 

personnel use in reviewing MML applications and requests for amendments to current MMLs. 

In order for the NRC to issue an MML to a Federal organization, the NRC must ensure that the 

organization is capable of performing certain functions and activities in a manner that meets the 

same standards that the NRC (pursuant to the Atomic Energy Act of 1954) applies to itself when 

it performs these functions and activities. To be granted an MML, a Federal organization must 

therefore demonstrate that it has a regulatory program that, among other things, can safely 

issue permits for the possession and use of byproduct, source, and special nuclear material at 

multiple sites, and has an organizational structure capable of providing adequate oversight and 

inspection of its permittees. 

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

radioactive materials under an MML. A team composed of staff from NRC Headquarters and 

NRC regional offices prepared this document, drawing on members’ collective experience in 

radiation safety in general and as specifically applied to MMLs. 

NUREG–1556, Volume 10, Revision 1, is not a substitute for NRC or Agreement State 

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

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

they include a basis for the staff to make the determinations needed to issue or continue 

a license. 

The comments received during the public comment period for NUREG–1556, Volume 10, 

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

Agencywide Documents and Management System (ADAMS) under ML15159B271. Access to 

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

comments received by the NRC included general corrections, comments on financial status, 

and comments on the corrective action program. 

 

Daniel S. Collins, Director 

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

Office of Nuclear Materials Safety and Safeguards 
vii 

TABLE OF CONTENTS 

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

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

ACKNOWLEDGMENTS .............................................................................................................. ix 

ABBREVIATIONS ....................................................................................................................... xi 

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

1.1 NRC Review Process and Criteria ............................................................................ 1-1

1.2 Definition and Description .......................................................................................... 1-1

1.3 Issuance Criteria for a Master Materials License ...................................................... 1-2

1.4 Master Materials Licensee Authorizations ................................................................. 1-3

1.5 Pre-licensing Visit and Readiness Review ................................................................ 1-4

1.6 Programs Not Warranting a Master Materials License .............................................. 1-4

2 FILING A MASTER MATERIALS LICENSE APPLICATION ............................................ 2-1

2.1 Application Preparation ............................................................................................. 2-1

2.2 Where to File ............................................................................................................. 2-1

2.3 Paper Applications ..................................................................................................... 2-1

2.4 Electronic Applications .............................................................................................. 2-2

2.5 Identifying and Protecting Sensitive Information ....................................................... 2-2

2.6 Letter of Understanding ............................................................................................. 2-4

2.7 Permitting and Enforcement History .......................................................................... 2-5

3 APPLICATION AND LICENSE FEES ................................................................................ 3-1

4 SAFETY CULTURE ............................................................................................................ 4-1

5 CONTENTS OF AN APPLICATION ................................................................................... 5-1

5.1 NRC Form 313, Item 1: License Action Type ........................................................... 5-2

5.2 NRC Form 313, Item 2: Name and Mailing Address of Applicant ............................ 5-2

5.3 NRC Form 313, Item 3: Address(es) Where Licensed Material Will Be Used 

or Possessed ............................................................................................................. 5-2

5.4 NRC Form 313, Item 4: Person To Be Contacted About This Application ............... 5-3

5.5 NRC Form 313, Item 5: Radioactive Material ........................................................... 5-3

5.6 NRC Form 313, Item 6: Purpose(s) for Which Licensed Material Will 

Be Used ..................................................................................................................... 5-5

5.7 NRC Form 313, Item 7: Individual(s) Responsible for the Radiation Safety 

Program and Their Training and Experience ............................................................. 5-6

5.7.1 Senior Management .................................................................................. 5-6

5.7.2 Master Radiation Safety Committee .......................................................... 5-8

5.7.3 Radiation Control Program Director ........................................................ 5-10

5.7.4 Other Radiation Control Program Staff .................................................... 5-11

5.8 NRC Form 313, Item 8: Training for Individuals Working In or Frequenting 

Restricted Areas ...................................................................................................... 5-11

5.9 NRC Form 313, Item 9: Facilities and Equipment .................................................. 5-12

5.10 NRC Form 313, Item 10: Radiation Safety Program .............................................. 5-13

5.10.1 Radiation Control Program–An Overview ................................................ 5-13

5.10.2 Previous Licenses ................................................................................... 5-15

5.10.3 Material Control and Accountability ......................................................... 5-15

5.10.4 Regulatory Conformance ......................................................................... 5-16
viii 

5.10.5 Updating of Radiation Control Program Documents ............................... 5-17

5.10.6 Management Support and Radiation Control Program Structure ............ 5-18

5.10.7 Radiation Control Policies–Administrative Controls and Provisions ........ 5-19

5.10.8 Master Radiation Safety Committee Responsibilities .............................. 5-20

5.10.9 Radiation Control Program Director Responsibilities ............................... 5-22

5.10.10 Permitting and Inspection Staff ................................................................ 5-23

5.10.11 Radiation Control Program Internal Procedures ...................................... 5-24

5.10.12 Management and Master Radiation Safety Committee Audits ................ 5-24

5.10.13 Permitting Procedures ............................................................................. 5-25

5.10.14 Program To Minimize Contamination at Permittee Facilities ................... 5-27

5.10.15 Decommissioning of Permit Activities and Permit Termination ............... 5-27

5.10.16 Financial Assurance ................................................................................ 5-30

5.10.17 Inspection and Enforcement Procedures ................................................ 5-30

5.10.18 Corrective Action Program ...................................................................... 5-31

5.10.19 Incident/Emergency Response Procedures ............................................ 5-32

5.10.20 Security Program for Category 1 and Category 2 

Radioactive Material ................................................................................ 5-34

5.10.21 Procedures for Handling Allegations ....................................................... 5-35

5.11 NRC Form 313, Item 11: Waste Management ....................................................... 5-36

5.12 NRC Form 313, Item 12: License Fees .................................................................. 5-36

5.13 NRC Form 313, Item 13: Certification .................................................................... 5-37

6 LICENSE AMENDMENTS .................................................................................................. 6-1

7 APPLICATIONS FOR EXEMPTIONS ................................................................................ 7-1

8 TERMINATION OF THE MASTER MATERIALS LICENSE .............................................. 8-1

APPENDICES 

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

APPENDIX B SUGGESTED FORMAT FOR PROVIDING INFORMATION 

REQUESTED IN ITEMS 2, 3, AND, 5 THROUGH 11 OF 

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

APPENDIX C SAMPLE LETTER OF UNDERSTANDING BETWEEN THE 

MASTER MATERIALS LICENSEE AND THE U.S. NUCLEAR 

REGULATORY COMMISSION ..................................................................... C–1 

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

APPENDIX E COMMENCEMENT OF CONSTRUCTION AT EXISTING AND 

PROPOSED BYPRODUCT (INCLUDING IRRADIATORS), 

SOURCE, AND SPECIAL NUCLEAR MATERIAL FACILITIES WITH 

SIGNIFICANT ENVIRONMENTAL IMPACTS ............................................... E–1 

APPENDIX F CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

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

ACKNOWLEDGMENTS 

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

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

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

Regulatory Commission who provided comments and technical information that assisted in the 

development of this report. 

The Participants for this Revision 

Browder, Rachel 

Cook, Jackie 

Elliott, Robin 

Herrera, Tomas 

Johnson, Robert 

Masnyk Bailey, Orysia 

Null, Kevin G. 

Seeley, Shawn W. 

Simmons, Michelle 

Xu, Shirley S. 

xi 

ABBREVIATIONS 

ADAMS Agencywide Documents Access and Management System 

ALARA as low as is reasonably achievable 

CAP corrective action program 

CATX categorical exclusion 

CERCLA Comprehensive Environmental Response, Compensation, and Liability Act 

CFR Code of Federal Regulations

DOJ Department of Justice 

DOT Department of Transportation 

DP decommissioning plan 

EA environmental assessment 

EIS environmental impact statement 

ER environmental review 

FR Federal Register 

FSSR final status survey report 

IMC Inspection Manual Chapter 

IN Information Notice 

IROFS items relied on for safety 

ISG Interim Staff Guidance 

LOU Letter of Understanding 

MML Master Materials License or Master Materials Licensee 

NEPA National Environmental Protection Act 

NHPA National Historic Preservation Act of 1966 

MRSC Master Radiation Safety Committee 

NMSS Office of Nuclear Materials Safety and Safeguards 

NRC U.S. Nuclear Regulatory Commission 

NSTS National Source Tracking System 

NSTTR National Source Tracking Transaction Reports 

OI Office of Investigations 

OMB Office of Management and Budget 

PII Personally Identifiable Information 

PM project manager 

RCP Radiation Control Program 

RCPD Radiation Control Program Director 

RIS Regulatory Issue Summary 

SNM special nuclear material 

SOP standard operating procedures 

U.S.C. United States Code 

1-1 

1 PURPOSE OF REPORT 

This report provides guidance to Federal organizations preparing a new Master Materials 

License (MML) application and those Federal organizations with existing MMLs when applying 

for a license amendment. In addition, it provides the criteria the U.S. Nuclear Regulatory 

Commission (NRC) license reviewers and other NRC personnel use in reviewing MML 

applications and current MMLs. For the NRC to issue an MML to a Federal organization, the 

NRC must ensure that the organization is capable of performing certain functions and activities 

in a manner that ensures compliance with the Atomic Energy Act of 1954, as amended, and 

other applicable regulations consistent with protecting the public health and safety and 

the environment. 

Thus, this document focuses on the information the Federal organization must provide to the 

NRC to ensure that the applicant has adequate staff, facilities, programs, and procedures 

necessary to assume the regulatory tasks authorized in the license, and that, with respect to 

NRC-regulated materials, the MML permittees are subject to the same licensing and inspection 

requirements and policies as other NRC licensees. 

To the extent an applicant chooses to take a different approach, it should justify why the 

requested information is not necessary in light of the information provided. In the absence of 

justification, the applicant should opt to use the approach in this document in formatting 

its application. 

1.1 NRC Review Process and Criteria 

After receipt of an MML application, an NRC MML project manager (PM) will be designated at 

the NRC regional office where the MML will be based. An MML application review team, 

consisting of headquarters and regional staff (including the MML PM), will be established to 

review the application. Because the existing organization’s licenses may be located in multiple 

regions, communication across the regions and headquarters is necessary. 

The NRC will review the applicant’s regulatory commitment to follow NRC requirements and 

criteria, as evidenced by the license application, inspection history of the organization’s 

individual licenses, financial status and stability, clerical and professional staffing of the 

proposed inspection and permitting programs, independence of MML management structure, 

and commitment to the MML. 

The NRC staff should conduct a readiness review, as described in Section 1.5, “Prelicensing 

Visit and Readiness Review,” before issuing any new MML. During the readiness review 

process, the NRC staff will visit the applicant and review the applicant’s operational and 

administrative readiness to assume the responsibilities of an MML. 

1.2 Definition and Description 

An MML is a material (byproduct, source, and/or special nuclear material) license issued to a 

Federal organization, authorizing the use of radioactive material at multiple sites. The MML 

authorizes the licensee to issue permits for the possession and use of licensed material under 

the license, and provides a framework for oversight and internal licensee inspection of 

its permittees. 
1-2 

Federal agencies licensed by the NRC are not subject to Agreement State radiation control 

regulations. Thus, Federal licensees who are authorized to work at temporary jobsites under 

their NRC licenses may do so anywhere in the U.S. and its territories. 

Please note that throughout this document, the terms “licensee” and “permittee” are utilized. 

The term licensee is utilized for describing items that must be submitted by the applying entity 

(i.e., the MML), because it has the overall responsibility for complying with the regulations. The 

MML may establish requirements and commitments through its permitting and inspection 

procedures and policies to ensure compliance of the entities it authorizes to utilize materials 

through the issuance of permits (i.e., permittees). 

In order for the NRC to issue an MML to a Federal organization, the NRC must ensure that the 

organization is capable of performing certain functions and activities in a manner that meets the 

same standards that the NRC (pursuant to the Atomic Energy Act of 1954) applies to itself when 

it performs these functions and activities. To be granted an MML, a Federal organization must 

therefore demonstrate that it has a regulatory program that, among other things, can safely 

issue permits for the possession and use of byproduct, source, and special nuclear material at 

multiple sites, and has an organizational structure capable of providing adequate oversight and 

inspection of its permittees. The NRC will provide current NRC policies and procedures to the 

licensee, so that the licensee can develop and implement a program consistent with the 

NRC’s program. 

The MML does not have expiration dates. Instead, as part of biennial inspections by the NRC of 

the licensee, the NRC and the licensee will evaluate the need to refresh any specific items in 

the license, license commitments, or the Letter of Understanding (LOU). A master materials 

licensee is an NRC licensee that is required to meet NRC regulatory requirements. The MML 

grants the licensee the authority and flexibility to manage and implement its radiation safety 

program. As a result, the organization must demonstrate that it has a program that is consistent 

with the NRC’s regulations. For example, Title 10 of the Code of Federal Regulations (10 CFR) 

30.33(a)(3) requires that licensees be qualified by training and experience to use materials for 

the purposes requested. Because this includes the issuance of permits by the MML for the 

possession and use of byproduct, source, and special nuclear material at multiple sites, the 

MML must have a centrally controlled program capable of providing independent oversight and 

inspection of its permittees. 

In order to provide consistency with the NRC’s training program, the licensee’s inspectors and 

permit reviewers should meet the training requirements in Inspection Manual Chapter 

(IMC) 1248, “Formal Qualifications Program for Federal and State Material and Environmental 

Management Programs,” or the requirements of an equivalent training and qualification 

program. In addition, the MML should use the NRC’s licensing and inspection guidance and 

should have a system for tracking its permitting and inspection actions. 

Under IMC 2810, “Master Material License Oversight and Inspection Program,” the NRC 

inspects MMLs at least biennially to evaluate the licensee’s implementation of its program. 

1.3 Issuance Criteria for a Master Materials License 

The NRC will only issue an MML to a Federal organization that successfully meets the criteria in 

10 CFR 30.33, “General requirements for issuance of specific licenses”; 10 CFR 40.32, 

“General requirements for issuance of specific licenses”; or 10 CFR 70.31, “Issuance of 

licenses,” as applicable, and can demonstrate that it is qualified to be granted an MML. 
1-3 

Before filing an MML application, the Federal organization should have a centrally controlled 

program in place for at least 5 years. The applicant should describe in general terms the 

purposes for which it will use licensed material and explain why an MML is needed. The MML 

applicant should demonstrate its readiness for an MML by effectively performing the following 

through the centrally controlled program: 

 Managing the use of byproduct materials under NRC-specific licenses of broad and 

limited scope. The organization will do this by receiving, reviewing, and resolving 

licensing actions of its proposed permittees before submittal to the NRC. 

 Conducting inspections of its prospective permittees and accompanying NRC staff 

during NRC inspections of the same. The NRC will compare the applicant’s existing 

licensees’ performance records with that of other similar licensees for the same 

time period. 

 Developing programs, policies, and procedures in the following areas: staffing 

and training, permitting, inspecting, enforcement, incidents, allegations, security, and 

decommissioning. 

 Establishing the following elements: centralized and independent administrative 

structure and organization, staff, facilities, equipment, and procedures adequate to 

protect the health and safety of workers and the public against radiation hazards from 

the materials and uses over which the licensee proposes to assume responsibility for 

permitting and inspecting. 

The applicant should demonstrate its readiness to assume the responsibilities of an MML as 

evidenced by acceptable performance of the licensee’s centrally controlled program based on 

an operational readiness review described in Section 1.5 conducted by the NRC. 

1.4 Master Materials Licensee Authorizations 

An MML, through its Master Radiation Safety Committee (MRSC), may permit any radioactive 

material authorized in the MML to be possessed and used by its permittees. The MML 

applicant may also request authorization to issue permits for the possession and use of 

specifically licensed quantities of source and special nuclear material. To ensure licensing and 

inspecting uniformity for MML permittees, the MRSC permitting criteria and inspection program 

should be consistent with NRC licensing, inspection and enforcement policies, procedures, and 

guides, and must be consistent with NRC regulations. 

The LOU (discussed in Section 2.6, “Letter of Understanding”) will, among other things, identify 

certain exclusionary activities that the MML cannot conduct, unless specifically authorized on 

the license. Typically, the exclusions stated in an LOU provide that MMLs shall not 

 grant exemptions to NRC regulations 

 conduct tracer studies in the environment involving the direct release of radioactive 

material (field uses) 

 conduct activities authorized under 10 CFR Part 32, “Specific domestic licenses to 

manufacture or transfer certain items containing byproduct material”; 10 CFR Part 34, 

“Licenses for industrial radiography and radiation safety requirements for industrial 
1-4 

radiographic operations”; 10 CFR Part 36, “Licenses and radiation safety requirements 

for irradiators”; or 10 CFR Part 39, “Licenses and radiation safety requirements for 

well logging” 

 add or cause the addition of byproduct material to any food or other product designated 

for ingestion or inhalation by, or application to, a human being, unless specifically 

authorized (e.g., for medical use) 

1.5 Pre-licensing Visit and Readiness Review 

After the NRC staff reviews an application for an MML and determines it is generally complete 

and substantially responsive to the information required on NRC Form 313 and this guidance, 

the NRC will schedule at least one pre-licensing visit at the MML applicant’s Radiation Control 

Program (RCP) central office. At a minimum, the pre-licensing visit will include a meeting with 

the applicant’s RCP staff and may, as necessary, include a meeting with the applicant’s senior 

management and proposed MRSC members. 

A pre-licensing visit provides the NRC staff an opportunity to 

 better evaluate the applicant’s proposed program and necessity for an MML 

 meet with the applicant’s RCP staff, senior management, and proposed MRSC members 

 communicate the importance of the applicant’s responsibilities 

 discuss deficiencies in the application and agree on additional information and 

commitments that will be required 

Before issuing an MML, the NRC staff will perform a readiness review to determine the 

operational and administrative readiness of the centrally controlled RCP to assume the 

responsibilities of an MML. The purpose of the readiness review is to determine whether the 

applicant has a centralized control program and whether it has met the criteria described in 

Section 1.3, “Application and License Fees,” of this guidance for issuance of an MML. In the 

readiness review, the NRC staff will examine the operational and administrative performance of 

the centrally controlled RCP with regard to (i) management oversight, document management, 

and radiation control procedures; (ii) status of the inspection program; (iii) technical quality of 

inspections; (iv) technical staffing and training; (v) technical quality of permitting actions; 

(vi) status of the permitting program; (vii) incident and allegation handling programs; 

(viii) enforcement program; (ix) security program; and (x) decommissioning program, 

as applicable. 

In addition, to further evaluate the applicant’s level of centralized control of the program, the 

NRC staff will conduct independent site visits at a select number of permittees that will be under 

the MML to review the methods, frequency, and effectiveness of communications between the 

applicant’s RCP office and its permittees. 

1.6 Programs Not Warranting a Master Materials License 

If the NRC determines that the issuance of an MML is not warranted, the applicant may 

continue with its existing licensed activities and may submit an application for an MML at a later 

date without prejudice. 
2-1 

2 FILING A MASTER MATERIALS LICENSE APPLICATION 

An applicant for a Master Materials License (MML) should submit its application, including a 

draft Letter of Understanding (LOU) (see Section 2.6 and Appendix C of this NUREG), a 

description of the applicant’s regulatory performance and centralized experience for the last 

5 years (see Section 2.7 of this NUREG), and a completed U.S. Nuclear Regulatory 

Commission (NRC) Form 313 (see Appendix A of this NUREG), to NRC Headquarters. 

2.1 Application Preparation 

Applicants for an MML should do the following: 

 Use the most recent guidance in preparing an application. 

 Complete NRC Form 313 (Appendix A of this NUREG) Items 1, 4, 12, 13, and part of 

Item 2, on the form itself. A link to the form is available at http://www.nrc.gov/readingrm/doc-collections/forms/. 

 Complete NRC Form 313 Items 3, and 5 through 11, and part of Item 2, on 

supplementary pages or use Appendix B of this NUREG. 

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

experience, and Radiation Control Program (RCP) are adequate to protect health and 

safety and minimize danger to life and property. 

 For each separate sheet other than NRC Form 313 and Appendix B pages submitted 

with the application, as applicable, identify and cross-reference submitted information to 

the item number on the application or the topic to which it refers. 

 Avoid submitting proprietary information and personally identifiable information (PII). 

 If submitted, proprietary, personal privacy, security-related, or other sensitive information 

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

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

Section 2.5, “Identifying and Protecting Sensitive Information”). 

2.2 Where to File 

An applicant seeking to become an MML should submit its application to the Division of 

Materials Safety, State, Tribal, and Rulemaking Programs at NRC Headquarters. The Office of 

Nuclear Materials Safety and Safeguards will then assign an NRC regional office to review 

the application. 

2.3 Paper Applications 

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

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

applicants should do the following: 
2-2 

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

into a document scanner. 

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

 Use 11-point or larger font. 

 Avoid stylized characters, such as script or italics. 

 Ensure that the print is clear and sharp. 

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

is best). 

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

by 10 CFR 30.32(c) (see Section 5.13, “Certification”). 

2.4 Electronic Applications 

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

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

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

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

treatment of nonpublic information. 

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

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

should be marked (as indicated in the list that follows) in accordance with 10 CFR 2.390 before 

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

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

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

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

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

requests for withholding information from public disclosure. 

 PII: 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 
2-3 

March 9, 2007, and Information Notice (IN) 2013-22, “Recent Licensing Submittals 

Containing Personally Identifiable Information,” dated November 15, 2013, which can be 

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

Summaries” and “Information Notices,” respectively: http://www.nrc.gov/reading-rm/doccollections/gen-comm/. 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

information on procedures and any updates is available at 

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

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

These include 

 trade secrets and commercial or financial information 

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

party other than an agency in litigation with the NRC 

 certain records or information compiled for law enforcement purposes 

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

concerning wells 

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

clearly unwarranted invasion of personal privacy. 

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

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

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

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

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

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

is needed and that the review will continue when the required information is received. 
2-4 

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

withdrawing the information or application, as permitted in 10 CFR 2.390. If the applicant 

decides not to withdraw the information or application, the NRC will notify the applicant in writing 

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

concerning the proprietary status of the information. 

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

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

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

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

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

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

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

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

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

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

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

consultants have signed the appropriate agreements for handling proprietary information. 

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

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

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

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

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

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

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

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

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

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

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

such information from public disclosure. 

2.6 Letter of Understanding 

The LOU is a document that identifies the responsibilities and requirements for coordination 

between the MML and the NRC, as well as those responsibilities that are retained by the NRC. 

The LOU is signed by representatives from both agencies. 

The following are some examples of responsibilities that may be divided: 

 administrative 

 environmental 

 permitting 

 inspection 

 allegations 

 enforcement 

 investigations 
2-5 

 decommissioning 

 developing procedures 

In the following examples of responsibilities that will not be shared, the licensee would 

continue to: 

 Report to and notify the NRC in accordance with regulatory requirements. 

 Request authorization for exemptions to the regulations. 

 Submit environmental assessment reports pursuant to 10 CFR Part 51, “Environmental 

Protection Regulations for Domestic Licensing and Related Regulatory Functions.” 

 Submit alternate disposal requests in accordance with 10 CFR 20.2002, “Method for 

obtaining approval of proposed disposal procedures.” 

 Submit decommissioning financial assurance in accordance with 10 CFR 30.35, 

“Financial assurance and recordkeeping for decommissioning.” 

 Submit an emergency plan for possession of licensed materials pursuant to 

10 CFR 30.32, “Application for specific licenses.” 

 Request authorization for issuance of a permit to individuals or other entities that are not 

a part of the licensee’s organization. 

 Request authorization for issuance of a permit to individuals or other licensee entities 

to work at a new permanent location of use that is not at the MML’s federally 

controlled facility. 

Response from Applicant: 

 Submit a draft LOU that defines and describes the division of responsibilities and the 

requirements for coordination between the applicant and the NRC utilizing Appendix C 

as an example. The LOU will be finalized and signed by the applicant and the NRC prior 

to issuance of a new license. 

2.7 Permitting and Enforcement History 

An MML will be issued only to Federal organizations with (i) a good regulatory performance 

record, based on NRC licensing and inspection of prior activities; (ii) experience in centralized 

management oversight and coordination of permitting, inspection, enforcement efforts; and 

(iii) experience in decommissioning activities, as applicable. Management oversight and 

coordination experience will also be assessed during the readiness review. 

The NRC will evaluate the applicant’s performance using, at a minimum, the 

following indicators: 

 demonstrated proficiency at completing permittee licensing applications 

 timely and effective communications within the organization at all levels regarding 

radiation safety and security program issues 
2-6 

 self-identification and correction of safety or security issues, evaluation of the “extent of 

conditions” (i.e., applicability to other permittees) as part of the corrective actions, and 

regulatory compliance 

 handling of employee radiation safety concerns 

 inspections that resulted in 

− noncited violations 

− violations cited in a notice of violation 

− violations considered for escalated enforcement 

 RCP handling of NRC findings with significant programmatic implications 

 number and type of NRC escalated enforcement cases 

 number and type of NRC recurrent violations/events 

 prompt actions taken by the RCP to restore safety, security, and compliance; 

comprehensive corrective actions to fully address the violation and any “extent of 

conditions”; and lasting corrective actions to prevent recurrence 

 identification of any missed opportunities to identify or prevent violations or events 

across all MML activities 

 handling of incidents and allegations 

Response from Applicant: 

 Describe regulatory performance in licensing, inspection, enforcement, and centralized 

experience in management oversight and coordination of licensing and inspection efforts 

for the previous 5 years. 
3-1 

3 APPLICATION AND LICENSE FEES 

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

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

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

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

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

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

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

disposition of an application or the withdrawal of an application. 

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

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

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

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

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

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

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

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

Office of the Chief Financial Officer at NRC Headquarters in Rockville, 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 is Fees.Resource@nrc.gov. 

4-1 

4 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 U.S. Nuclear Regulatory Commission (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 4-1 for the traits of a positive safety culture 

from the 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. 

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

performance of individuals and organizations to determine compliance with requirements and 

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

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

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

programs. The NRC recommends that a Master Materials License (MML) applicant develop 

and implement a corrective action program that will assist the licensee in identifying and 

correcting safety-related conditions. An MML that develops and implements a corrective action 

program will be more adept at identifying and correcting safety problems as well as evaluating 

effectiveness of the corrective action, both immediately and in the long term. Developing a 

corrective action program is an action that may correspond with the safety culture trait specified 

in Table 4-1 as “Problem Identification and Resolution” (issues potentially impacting safety are 

promptly identified, fully evaluated, and promptly addressed and corrected commensurate with 

their significance). However, licensees should be aware that this is just an example, and should 

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

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

Refer to Appendix D 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/about-nrc/safetyculture.html. 
4-2 

Table 4-1. 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 to identify 

discrepancies that might result 

in error or inappropriate 

action. 
5-1 

5 CONTENTS OF AN APPLICATION 

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

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

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

whether the proposed equipment, facilities, training and experience, and radiation safety and 

security programs satisfy regulatory requirements and are adequate to protect public health and 

safety and minimize danger to life and property. Consideration should be given, when 

developing the application, to the concepts of keeping exposure as low as is reasonably 

achievable (ALARA), minimizing contamination, and maintaining control of radioactive materials. 

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

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

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

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

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

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

considerations, including establishing administrative action levels and monitoring programs. 

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

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

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

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

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

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

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

material not in storage.” 

Refer to Appendix E of this report 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) 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), because 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 E 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. Throughout this document, 

descriptive items that will not be incorporated into the license as a requirement are indicated by 

a single asterisk (*). These descriptive items are for information only and will assist the NRC in 

gaining a complete understanding of the Master Materials License (MML) program as a whole. 

It is the intent of the NRC that these items will not be incorporated in the license. Applicants 

should clearly identify in the MML application information that constitutes descriptive 

information. Any changes in descriptive information that occur while the license is in effect 

should be communicated to the NRC to allow the NRC to determine the licensing significance of 

the changes and whether an amendment is needed.
5-2 

5.1 NRC Form 313, 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 (Not applicable for MML) XX-XXXXX-XX (Not Applicable) 

Check box A for a new license request. 

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

See “License Amendments” in Chapter 6 of this report. 

5.2 NRC Form 313, Item 2: Name and Mailing Address of Applicant 

Provide the mailing address where correspondence should be sent. A post office box number is 

an acceptable mailing address. 

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

Also, the applicant should specify the proposed location of the MML applicant’s Radiation 

Control Program (RCP) Office by providing 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). 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. 

This should be the location of the docketed permittee files for the MML or where they can be 

readily retrieved for review. 

Response from Applicant: 

 Provide location of MML applicant’s RCP Office. 

 Confirm whether the docketed permittee files for the MML will be located at the RCP 

Office. (Identification of the actual location of all MML program documents and files are 

requested in Section 5.9, “NRC Form 313, Item 9: Facilities and Equipment.”) 

5.3 NRC Form 313, Item 3: Address(es) Where Licensed Material Will Be 

Used or Possessed 

Federally Controlled Fixed Sites 

The licensee should maintain and have available at all times a current list of locations where 

permitted material will be used (i.e., permittee’s locations of use) by address, including program 

code used by the NRC. 
5-3 

Temporary Jobsites

If permittees will use radioactive material at temporary jobsites, the NRC must specifically 

authorize this activity on the MML. Applicants should indicate whether they will authorize 

permittees to use radioactive material at temporary jobsites so the NRC can include this 

information on the license. 

Field Studies 

If permittees will use radioactive material in field studies, the NRC must specifically identify and 

authorize these activities on the MML. NUREG–1556, Vol. 11, “Program-Specific Guidance 

about Licenses of Broad Scope,” contains information required for field use of licensed material. 

Other Sites 

If permittees intend to use radioactive material at facilities and sites (other than temporary 

jobsites) that are not located at the MML’s federally controlled facility, the NRC must approve 

these activities and specifically identify and authorize them on the MML. 

Response from Applicant: 

 Provide a current list of permittees, locations, and program code(s). 

 Identify permittees that will be authorized to use radioactive material at 

temporary jobsites. 

 Identify permittees that intend to use radioactive material in field studies. 

 Identify permittees that intend to use radioactive material at facilities and sites, other 

than temporary jobsites that are not located at the MML’s federally controlled facilities. 

5.4 NRC Form 313, Item 4: Person To Be Contacted About 

This Application 

The applicant should specify the individual who will be the RCP Director (RCPD), and include a 

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

numbers and e-mail addresses. This individual specified on Item 4 of NRC Form 313 will serve 

as the point of contact during the review of the application. 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. 

Response from Applicant: 

 Identify the individual who will be the RCPD and provide the individual’s 

contact information. 

5.5 NRC Form 313, Item 5: Radioactive Material 

While the primary authorization in the MML will specify “any radioactive material in any form and 

as needed or limited to some maximum quantity,” there may be specific additional line items for 

some radionuclides; therefore, the applicant should describe, in general, the licensed material 
5-4 

the applicant wishes to possess by isotope class (e.g., byproduct, source, or special nuclear 

material), chemical or physical form, and quantity (e.g., in curies or millicuries), etc. The NRC 

will describe the authorized uses of these materials on the license and use broad descriptive 

terms to do so. For example, the applicant should categorize this information into general areas 

of use (e.g., research and development activities, industrial activities, self-contained irradiators, 

instrument calibrators, and medical applications). The applicant should provide a list of the 

manufacturer and model number of all sealed sources used in devices (e.g., self-contained 

irradiators, panoramic irradiators, instrument calibrators, radiography cameras, etc.). The 

applicant should specify whether the device(s) is/are registered or not registered in accordance 

with 10 CFR 32.210, “Registration of product information.” 

The maximum quantity for each individual nuclide and total cumulative possession authorized 

by the MML for individual permittees should be commensurate with each permittee’s needs, 

facilities, procedures, personnel, and demonstrated experience/capability. The independent 

amounts of material at each permittee’s facility or site and not the aggregate of all materials 

possessed by the MML are used to determine whether decommissioning financial assurance or 

an emergency plan is necessary. The applicant should describe facilities or permittees that 

(i) may possess quantities of materials requiring financial assurance, in accordance with the 

requirements of 10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25, “Financial assurance and 

recordkeeping for decommissioning” or (ii) require consideration of the need for an emergency 

plan for responding to a release, in accordance with 10 CFR 30.32. 

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

sensitive and should be marked accordingly (see Section 2.5, “Identifying and Protecting 

Sensitive Information”). Category 1 and Category 2 sources must be tracked in the National 

Source Tracking System (NSTS) in accordance with 10 CFR 20.2207. 

After the NRC license is issued, the licensee needs to create an account in the NSTS to track, 

from cradle to grave, sealed sources with activities exceeding the activities listed in Appendix E 

of 10 CFR Part 20, “Nationally Tracked Source Thresholds.” The receipt, transfer, and disposal 

transactions of NSTS sources must be reported in accordance with 10 CFR 20.2207. More 

information on NSTS can be found in the NRC Web site at 

http://www.nrc.gov/security/byproduct/ismp/nsts.html. 

Response from Applicant: 

 Identify the licensed material to be possessed by isotope class (e.g., byproduct, source, 

or special nuclear material); chemical or physical form; quantity (e.g., in curie or 

millicurie), etc.; and general areas of use (e.g., research and development activities, 

industrial activities, self-contained irradiators, instrument calibrators, radiography, or 

medical applications). 

 Identify by manufacturer and model number all sealed sources used in devices 

(e.g., self-contained irradiators, panoramic irradiators, instrument calibrators, 

radiography cameras, etc.). The applicant should specify whether the device(s) is/are 

registered or not registered in accordance with 10 CFR 32.210. 

 Identify permittees that may possess quantities of materials requiring financial assurance 

or an emergency plan. 
5-5 

5.6 NRC Form 313, Item 6: Purpose(s) for Which Licensed Material Will 

Be Used 

The applicant should describe in general terms the purposes for which it will use licensed 

material and explain why an MML is needed. The uses should be consistent with the 

applicant’s prior licensed activities and categorized in a classification scheme according to the 

NRC’s licensing program codes. The NRC staff understands that the information provided 

regarding “purpose of use” in this section is a self-imposed limitation contained within the 

application. If an MML applicant wants to initiate an intended use other than that described in 

its application and incorporated in its license and Letter of Understanding (LOU), it should 

submit an amendment request to the license to modify/expand the purpose of use. Applicants 

should include a list of total possession limits for each category of use requested. 

Note: If the newly added purpose of use includes material use in a unique or specialized 

activity (e.g., sealed source fabrication), the applicant may be required to submit the criteria 

used by the Master Radiation Safety Committee (MRSC) in evaluating in-house requests for 

such use. In this specific example, NUREG–1556, Vol. 3, “Applications for Sealed Source and 

Device Evaluation and Registration,” provides guidance for the evaluation and registration of 

sealed sources and devices with the NRC.

The applicant should state whether it intends to use or approve sealed sources other than those 

that have been registered with the NRC’s Sealed Source and Device Registry and describe the 

training and experience of individuals responsible for reviewing applications for use. 

If the applicant has a permittee that wants to perform field studies that involve deliberately 

releasing licensed material to the environment, then the applicant should include the information 

outlined in NUREG–1556, Vol. 11, in the application, so that the NRC can evaluate and 

specifically authorize the field studies on the MML. 

Note: Regulations in 10 CFR 51.22, “Criterion for categorical exclusion; identification of 

licensing and regulatory actions eligible for categorical exclusion or otherwise not requiring 

environmental review,” include the issuance, amendment, or renewal of licenses for use of 

radioactive material for research and development and for educational purposes as categorical 

exclusions (CATX) from the requirement to prepare an environmental assessment (EA) or 

environmental impact statement (EIS); however, this CATX does not encompass field studies in 

which licensed material is deliberately released directly into the environment for purposes of the 

study (e.g., tagging animals or insects that remain in the wild). Field studies may require 

applicants to file an environmental report (ER) and the NRC to perform an EA pursuant to 

10 CFR Part 51, “Environmental protection regulations for domestic licensing and related 

regulatory functions.” Field studies that do not deliberately release radioactive material into the 

environment, such as tagging of animals and penning them to prevent escape, may be eligible 

for a CATX under 10 CFR 51.22. 

Any questions should be referred to the appropriate regional office. 

Response from Applicant:

 Explain why an MML is needed. 

 Describe in general terms the purposes for which licensed materials will be used. 
5-6 

 State whether you intend to use or approve sealed sources other than those that have 

been registered with the NRC’s Sealed Source and Device Registry, and describe the 

training and experience of individuals responsible for reviewing applications for use of 

these materials. 

 Identify any uses that are not identified as a CATX in 10 CFR 51.22 (including field 

studies deliberately releasing licensed material to the environment), and provide 

information needed for specific authorization. 

 Provide sufficient information about field studies where there is no planned deliberate 

release of radioactive material to the environment for the NRC to determine whether a 

categorical exclusion is appropriate. 

5.7 NRC Form 313, Item 7: Individual(s) Responsible for the Radiation 

Safety Program and Their Training and Experience 

The following sections are provided to assist the applicant in correctly identifying the individuals 

for the functional positions of senior management, MRSC, and RCPD. These sections provide 

descriptive information on some of the duties and responsibilities of these positions, which are 

also discussed in Section 5.10, “Radiation Safety Program.” In addition, as part of the 

information that should be submitted under Item 7 of NRC Form 313, the applicant should 

specify any delegations of authority for these positions and procedures used for the oversight of 

the program. Other aspects of program responsibilities should be submitted. 

5.7.1 Senior Management 

The importance of senior management’s role in the development and oversight of an MML 

program cannot be overemphasized. The NRC issues an MML to Federal agencies that are 

involved in extensive radioactive materials programs where the demand is great for a variety of 

radionuclides, uses, and locations of use across NRC regional boundaries. The NRC grants 

significant authority to MML management to develop and implement an appropriate RCP. An 

adequate RCP should ensure the implementation of consistent health, safety, and security 

programs by all of the proposed MML permittees. Consequently, the MML management should 

establish effective administrative controls, oversight, and provisions for organization and 

management, including management review and self-assessments that are essential to ensure 

safe operations under the license. 

The senior management oversight is normally accomplished by the establishment of an MRSC 

with routine participation by a senior management representative and reports to the senior 

manager for significant programmatic outcomes. Audits or reviews are accomplished under the 

purview of the MRSC and reported, at least annually, to senior management. 

When the NRC issues an MML, the organization’s senior management (the highest level of the 

licensee’s management) is responsible for the regulatory activities authorized under the license, 

including ensuring that a security program is developed and implemented in accordance with 

10 CFR Part 37, if applicable. Senior management and the MRSC need to ensure that the 

training, permitting, inspection, enforcement, event response, allegation resolution, 

decommissioning, and other regulatory activities are implemented and are consistent with the 

NRC’s policies and procedures. It is the responsibility of the NRC to provide the MML with 

current NRC policies and procedures; however, it is the responsibility of the MML management 

to incorporate NRC requirements and policies into the MML processes and programs. 
5-7 

The applicant should describe senior management oversight and processes used by the highest 

level of management to ensure that there is consistent and adequate control over MML activities 

(see Section 5.10). To ensure safe operations and compliance with regulatory requirements, 

such oversight should include senior management membership and active participation in 

regular meetings of the MRSC. The MRSC should have oversight of the RCPD and support 

staff and perform annual audits of the program. 

MMLs are required to establish an MRSC and RCP that represents management when 

reviewing and approving permit applications; therefore, senior management should delegate to 

the MRSC and the RCPD, in writing, sufficient authority, organizational freedom, and 

management prerogative, to communicate with and direct MML personnel at all levels regarding 

NRC regulations, MML provisions, and permit conditions. These delegations of authority are 

also addressed in Sections 5.10.8, “The Master Radiation Safety Committee Responsibilities,” 

and 5.10.9, “Radiation Control Program Director Responsibilities.” The licensee retains the 

ultimate responsibility for the conduct of licensed activities. It is also essential that the licensee 

devote sufficient financial resources (i.e., funds, equipment, personnel, materials) to support the 

RCP at all levels. 

The application should include an organizational chart of the applicant’s management structure 

depicting reporting paths, flow of authority, and the control of finances necessary to implement 

the MML. The applicant should include a statement empowering the MRSC by outlining its 

authority to oversee the licensed program and its responsibility for control and direction of the 

RCP and the RCPD. In addition, the applicant should describe the MRSC’s authority to 

suspend or terminate activities based on poor performance or violation of safety standards. 

These issues are addressed further in Section 5.10. 

Senior management should designate a point of contact to act as the liaison (typically the 

RCPD) between the MML and the NRC regional MML project manager (PM) during the 

application process, as well as during operation of the MML. The roles and responsibilities 

of the MML liaison should be described in the MML policies and procedures. The MML 

policies and procedures should describe the expected types of interactions and exchanges 

of information between the MML and the NRC, including both formal and informal 

communication mechanisms. 

Response from Applicant: 

 Provide an organizational chart depicting the licensee’s management structure, reporting 

paths, flow of authority, control of finances, and geographical location of all management 

and staff components of the RCP. 

 Describe established management controls and oversight used to ensure that permitted 

activities are properly conducted. This should include senior management’s established 

administrative controls and provisions relating to organization and management, 

including management review necessary to ensure adequate protection of public health, 

safety and security, and the environment. 

 Provide senior management’s written delegations to the MRSC and RCPD providing for 

sufficient authority, organizational freedom, and management prerogative to 

communicate with and direct MML personnel at all levels regarding NRC regulations, 

MML provisions, and permit conditions. 
5-8 

 Provide the point of contact as the liaison to the NRC MML PM and describe the 

expected types of interactions and exchanges of information, including both formal and 

informal communication mechanisms. 

 Confirm and describe senior management commitment to devote sufficient financial 

resources (e.g., funds, equipment, personnel, materials) to support the RCP at all levels. 

 Describe the senior management oversight and mechanisms used by management to 

ensure adequate control over MML activities, such as using the MRSC to audit and 

evaluate overall program implementation. The senior management oversight activities 

should include 

− membership and active participation in MRSC meetings 

− oversight of RCPD and support staff 

− annual audits of the program to ensure safe operations, regulatory compliance, and 

consistency with the NRC’s policies and procedures 

5.7.2 Master Radiation Safety Committee 

The MRSC not only has the authority to control and direct the centralized RCP, but it also 

serves as a means by which the highest level of the licensee’s senior management gains an 

overview of the entire MML program (i.e., permittee activities and the respective roles of the 

RCPD, MRSC, and permittees). The MRSC provides guidance and information on the RCP to 

the highest level of senior management; ensures that adequate resources are provided by 

licensee management for the committee and RCP office; and provides oversight to the RCPD in 

developing, implementing, and maintaining the RCP. The MRSC should ensure that the highest 

level of executive management is periodically given all relevant information regarding the RCP, 

particularly when the highest level of management will make decisions that may affect 

the program. 

Membership of the MRSC should include: 

 a senior manager from the applicant’s executive management organization to serve as 

the chairperson who is empowered with full authority to implement the MML by having 

stop work authority and authority to direct the RCP office 

 the RCPD 

 a manager capable of planning, programming, or budgeting the financial needs for 

the organization 

 managers capable of establishing RCP policies (these managers should be drawn 

from major divisions, departments, or organizational elements that represent the 

permittee community) 

Other members may include: 

 manager(s) responsible for establishing and implementing major program activities 

under the MML 
5-9 

 manager(s) who represent permitting and inspecting organizations 

 representative(s) from legal counsel 

 representative(s) of occupationally exposed workers 

The chairperson of the committee should be empowered, at a minimum, to do the following: 

 Set the agenda. 

 Direct committee meetings. 

 Determine the existence of a quorum. 

 Verify the minutes. 

 Summarize the committee’s position regarding decisions. 

 Sign all official documents of the committee. 

 Appoint a temporary replacement chairperson (not the RCPD) in the event of his/her 

required absence. 

 Vote. 

The following are duties of the RCPD: 

 Serve as a liaison between the MRSC and the RCP staff. 

 Inform the chairperson of staff commitments and resources. 

 Assist the chairperson in preparing the agenda. 

 Advise the committee of current regulations and proposed changes in NRC regulations, 

policies, and procedures. 

 Provide the committee with quarterly reports on the status of the program. 

 Advise the committee of any radiation safety or security trends that may need to be 

assessed or evaluated. 

In addition, the RCPD should arrange for and present an annual audit report that summarizes 

overall program activities; the results of program performance compared to regulatory 

requirements and license commitments (as determined through licensee and NRC inspections 

and evaluations); and their permitting actions, inspection reports, incidents/events, allegation 

responses, enforcement actions, and decommissioning, as applicable. 

Response from Applicant: 

 Describe the composition, duties, and functions of the MRSC. 
5-10 

 Identify the chairperson and individual members of the MRSC by position title and 

job description. 

 Describe the duties of the MRSC chairperson, and provide a commitment that the 

chairperson or management representative has access to financial and budgeting 

officials consistent with the agency’s usual funding methods and procedures. 

 Describe the duties of the RCPD. 

Note: The identities of the members of the MRSC are descriptive information and are not 

incorporated into the license. If there are significant changes to actual membership of the 

MRSC (i.e., functionally significant changes in position titles and job descriptions), the NRC 

should be notified. Notification is not needed for reorganizations that change the position titles 

without changing the basic radiation safety responsibilities of the position or for the 

reassignments of new individuals into designated positions. 

5.7.3 Radiation Control Program Director 

The RCPD should ensure that radiation safety activities are being performed according to 

approved policies and procedures and that the daily operation of the licensed program is in 

compliance with all regulatory requirements. Also, the RCPD should be involved with 

developing and implementing a security program in accordance with 10 CFR Part 37, if 

applicable. The RCPD implements the RCP with the assistance and support of the MRSC and 

senior management. The RCPD helps to ensure a clear understanding of mission goals and 

precise communications between the MRSC and the RCP staff. 

Senior management should select an RCPD who has sufficient training and experience to 

address all facets of the applicant’s RCP. The RCPD’s qualifications should include 

 an academic degree in a physical or biological science or engineering 

 specific training in radiation health sciences 

 considerable professional experience (generally a minimum of 5 years) with a broad 

spectrum of radioactive materials 

Generally, an RCPD at an MML should have 

 experience managing an RCP where a broad spectrum of isotopes was used and 

licensed activities were conducted 

 management abilities such as developing and administering a budget, supervising a 

staff, and having familiarity with human resource matters 

 good written and oral communication skills 

It is essential for the RCPD to have a thorough knowledge of NRC regulatory requirements. 

Response from Applicant: 

 Provide the minimum generic qualifications of the RCPD. 
5-11 

 Identify the individual*1

 designated as the RCPD. 

 Provide documentation*1

 on the education, training, and experience demonstrating the 

individual designated as the RCPD is qualified to manage the RCP. 

5.7.4 Other Radiation Control Program Staff 

The RCP professional staff should have the following qualifications: 

 sufficient education, training, and experience in the physical or life sciences 

 bachelor’s degree, or equivalent training and experience 

 specific training in the safe handling of radioactive materials and in the characteristics of 

ionizing radiation, units of radiation dose and quantities, radiation detection 

instrumentation, and biological hazards of exposure to radiation appropriate to the type 

and forms of byproduct to be used 

 additional training commensurate with the types of hazards and technology to 

be permitted 

 senior staff should have additional training and experience beyond their original areas of 

specialization to reflect the broader area of responsibility in their organization 

 commitment to continued training 

Written job descriptions, identifying professional qualifications needed to fill vacancies, should 

be prepared. Staff members whose primary duties include reviewing/issuing permits or 

conducting inspections must meet training qualifications equivalent to NRC license reviewers 

and inspectors. See Inspection Manual Chapter (IMC) 1248 for guidance on such qualifications. 

Response from Applicant: 

 Provide a list of the RCP office staff positions by job title, description, and number of 

individuals for each position. 

 Describe procedures and criteria for ensuring that members of the RCP office staff are 

adequately qualified. (These procedures are part of the RCP procedures generically 

addressed in 5.10.4, “Regulatory Conformance.”) 

 Provide management commitment to training and continued training of program staff in 

accordance with IMC 1248 or equivalent program for training and qualification of staff. 

5.8 NRC Form 313, Item 8: Training for Individuals Working In or 

Frequenting Restricted Areas 

The applicant must ensure that individuals receive training commensurate with their assigned 

 

1

Throughout this document, descriptive items that will not be incorporated into the license as a requirement are 

indicated by a single asterisk (*); see the introduction to Section 5 for more information. 
5-12 

duties to meet the requirements of 10 CFR Part 19, “Notices, Instructions and Reports To 

Workers: Inspection and Investigations.” If applicable, to meet the requirements of 10 CFR 

Part 37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,” 

applicants must ensure that the assigned individuals receive the requisite security training 

before permitting the facility. The established procedures should describe the licensee’s 

responsibility to maintain control of licensed material and secure it from unauthorized removal 

or access. 

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

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

with 10 CFR 37.43, “General security program requirements,” to ensure that those individuals 

who may have a responsibility to implement portions of the security program possess and 

maintain the knowledge, skills, and abilities to carry out their assigned duties and 

responsibilities effectively. For additional guidance on implementing 10 CFR Part 37 

requirements, see NUREG–2155, “Implementation Guidance for 10 CFR Part 37, “Physical 

Protection of Category 1 and Category 2 Quantities of Radioactive Material.”” Additional 

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

available in NUREG–2166, “Physical Security Best Practices for the Protection of 

Risk-Significant Radioactive Material.” 

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

review and approval. 

Response from Applicant: 

 Describe the training and experience required of individuals who will be required to work 

in, inspect, or frequent any restricted areas included under the MML. 

5.9 NRC Form 313, Item 9: Facilities and Equipment 

In accordance with 10 CFR 30.33, applicants must describe facilities and equipment used by 

the licensee to facilitate day-to-day operations. 

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

Category 2 quantity of radioactive material must, 

 Implement the physical protection requirements in 10 CFR Part 37 for material in use 

and storage, at both permanent and temporary jobsites. 

 In accordance with 10 CFR 37.49 and 10 CFR 37.53, be able to monitor and 

immediately detect and assess any unauthorized entries into security zones, including 

those surrounding mobile devices. 

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

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

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

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

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

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

review and approval.
5-13 

Response from Applicant: 

 Provide location and description of all facilities used by the MML to carry out its 

activities.*2

 State in the application where all docketed and required files and records will be 

maintained. 

 Provide a list and description of the laboratory equipment such as radioactivity counting 

systems, portable radiation survey meters, air monitoring, or other devices necessary for 

conducting the inspection of permittees.*2

5.10 NRC Form 313, Item 10: Radiation Safety Program 

The applicant should refer to Section 5.7, “NRC Form 313, Item 7: Individuals Responsible for 

the Radiation Safety Program,” for additional discussion on the role and duties of senior 

management, the chairperson of the MRSC, RCPD, and MRSC in the RCP. Information such 

as delegations of authority and establishment of oversight programs that are part of the 

authorities and management of an RCP may have been requested under Item 7 of NRC 

Form 313, while discussion of other aspects of program responsibilities appears under Item 10 

of NRC Form 313. 

5.10.1 Radiation Control Program–An Overview 

The RCP is implemented by the MRSC. This includes the central control over all elements of 

the NRC-regulated radiation safety program and the management of the permitting and 

inspection activities. These activities also include, but are not limited to, enforcement, event 

response, emergency response, allegation resolution activities, and decommissioning, as 

applicable. The applicant should commit to implementing permitting and inspection programs in 

accordance with NRC criteria. As discussed in Section 5.10.4, the applicant may adopt 

alternative program procedures, provided these procedures are described as part of the 

license application. 

Applicants for MMLs should have established administrative controls that should include, at 

a minimum: 

 central organization and management structure 

 procedures 

 recordkeeping 

 material control and accountability 

 management review 

 training qualification plan 

The requirement to develop, document, and implement a radiation protection program 

commensurate with the scope of the license request is contained in 10 CFR 20.1101, “Radiation 

protection programs.” The recordkeeping requirements related to the program are contained in 

10 CFR 20.2102, “Records of radiation protection programs.” 

 

2

Throughout this document, descriptive items that will not be incorporated into the license as a requirement are 

indicated by a single asterisk (*); see the introduction to Section 5 for more information. 
5-14 

The applicant should include a complete description of its RCP. In this section, that description 

should include concise commitments and a narrative overview of the detailed program 

described in other sections. Both the narrative overview and the more detailed documents 

describing the program should, at a minimum, address the following elements: program 

authorities and responsibilities, communications, quality control surveillance, program audits, 

procurement, staff selection and qualification criteria, training plan, information dissemination, 

document control and retrieval, and other considerations essential to the successful 

implementation of the RCP. 

Note: The applicant should commit to following specific NRC guidance documents in 

implementing its permitting, inspection, enforcement, and decommissioning programs. These 

NRC guidance documents may be adopted in their entirety. Other NRC guidance documents 

may be modified to reflect the unique characteristics of the applicant’s program. Documents 

adopted in their entirety can be included in the description by reference. When NRC guidance 

is used, the applicant should commit to maintaining its procedures to ensure consistency with 

the NRC procedures. 

Both the concise narrative overview description of written administrative control procedures for 

the RCP in this section and the procedures themselves need to be sufficient in detail, clarity, 

and specificity to describe how management oversight for program activities will be carried out. 

Response from Applicant: 

 Provide a concise, narrative overview description of the RCP. 

 Describe the centralized administrative controls and provisions for 

− organization and management structure 

− procedures 

− recordkeeping 

− material control and accountability 

− management review 

 Describe the permitting, inspection, enforcement, and decommissioning programs. 

 Describe the incident response and allegation handling programs. 

 Describe the staff training and qualification programs. 

 Commit to updating procedures to maintain consistency with NRC policies, procedures, 

and guidance. 

Note: While both the description of the written administrative control processes and the 

program elements, such as permitting, inspection, enforcement, incidents, allegations, training, 

and decommissioning, should be concise, the descriptions should also contain sufficient detail, 

clarity, and specificity in order to describe how management oversight for the program activities 

will be carried out and how the program functions. All elements in the narrative overview 

description of the RCP should concisely address the following (a narrative overview description 

is not needed when NRC guidance documents are included by reference in the RCP, because 

they were adopted in their entirety): 
5-15 

− program authorities and responsibilities 

− communications 

− quality control surveillance 

− program audits 

− procurement 

− staff selection and qualification 

− information dissemination, document control, and retrieval 

− other considerations essential to the successful implementation of the RCP 

5.10.2 Previous Licenses 

Simultaneously, with the issuance of permits by the MML, the NRC will terminate the 

superseded individual NRC licenses. Because the applicant may elect to have regulatory 

authority over only some types of materials (e.g., byproduct but not source or special nuclear 

materials), in order for the NRC to terminate the correct licenses, the NRC must have a list of 

those licenses that will be incorporated into the MML program. 

The regions and Office of Nuclear Materials Safety and Safeguards (NMSS) are responsible for 

transferring NRC license docket files to the primary regional office in which the MML will be 

based. The MML PM should be kept informed of these activities and oversee the coordination 

and disposition of the NRC license docket files. The NRC license docket files may be 

maintained in the NRC regional office, transferred to the MML, or archived. 

Response from Applicant: 

 List the radioactive materials licenses the applicant wants to include in the MML.*3

5.10.3 Material Control and Accountability 

In accordance with 10 CFR Part 20, “Standards for Protection Against Radiation,” and 

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

licensees must develop, implement, and maintain written procedures for ensuring receipt, 

control, and accountability of licensed material. See NUREG–1556, Vol. 11, for additional 

useful information on material receipt and accountability. 

The licensee must update transactions in the National Source Tracking System (NSTS) 

in accordance with 10 CFR 20.2207, “Reports of transactions involving nationally 

tracked sources.” 

Licensees must maintain records of receipt, inventory, transfer, and disposal of licensed 

material in accordance with 10 CFR 30.51, “Records”; 10 CFR 40.61, “Records”; or 

10 CFR 70.51, “Records requirements.” 

Licensed materials should be tracked from the time that they are manufactured or imported 

through the time of their disposal, export, or decay below quantities requiring inclusion in the 

NSTS to ensure accountability at all times. 

 

3

Throughout this document, descriptive items that will not be incorporated into the license as a requirement are 

indicated by a single asterisk (*); see the introduction to Section 5 for more information. 
5-16 

MML applicants should develop and maintain an effective inventory and accountability method, 

establishing procedures for properly transferring, controlling, and accounting for material 

throughout the applicant’s organization, including its movement among facilities. The inventory 

and control method should also ensure that the permittees’ authorized possession limits are 

not exceeded. 

Licensees should develop procedures to identify when licensed material is lost, stolen, or 

misplaced (also may have to be reported pursuant to 10 CFR 30.50, “Reporting requirements”). 

In addition to general security requirements for shipment and transfer of a Category 1 or 

Category 2 quantity of radioactive materials, in accordance with 10 CFR 37.75 and 37.77, any 

licensee that ships Category 1 quantities of radioactive material must preplan and coordinate 

shipment, and must provide advanced notification of shipments. Under 10 CFR 37.75, any 

licensee that ships Category 2 quantities of radioactive material shall coordinate the shipment of 

such material. For additional guidance on implementing 10 CFR Part 37 requirements, see 

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

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

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

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

Radioactive Material.” 

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

review and approval. 

Response from Applicant: 

 Describe the administrative controls and provisions relating to materials control 

and accountability. 

 Describe the inventory control and accountability method of licensed material. 

 Provide a statement that “We will develop, implement, and maintain procedures for 

ensuring accountability of licensed materials at all times.” 

 Provide a statement that “We will comply with the NSTS reporting requirement as 

described in 10 CFR 20.2207, ‘Reports of transactions involving nationally 

tracked sources’.” 

5.10.4 Regulatory Conformance 

The applicant must commit to follow NRC regulations, but may use operational control levels 

that are more stringent than those of the NRC. However, at a minimum, the applicant’s 

requirements must be as restrictive as the NRC’s regulations. 

The applicant should commit to following specific NRC guidance documents in implementing its 

permitting and inspection programs. These NRC guidance documents may be adopted in their 

entirety. Other NRC guidance documents may be modified to reflect the unique characteristics 

of the applicant’s program. Documents adopted in their entirety can be included in the RCP 

description by reference and do not have to be inserted in their entirety. 

When the applicant commits to use NRC guidance, the NRC must have assurances that the 
5-17 

applicant’s program is updated as NRC guidance is changed and that the applicant’s staff has 

training in regard to the updated guidance. 

In order for the NRC to approve the MML application, it must contain all policies, procedures, 

directives, and guidance the applicant has developed and will use to manage its RCP pursuant 

to NRC regulations, policies, and guides. (See Section 5.7.4, “Other Radiation Control Program 

Staff,” and the remainder of sections in 5.10 for discussions specific to staff qualification, 

administrative control, organizational, audit, permitting, inspection, enforcement, incident 

response, emergency response, decommissioning, and allegation policies, procedures, and 

guidance documents that must be submitted.) The applicant must specify those NRC policies, 

procedures, and guidance that it will adopt in their entirety. The NRC will review the policies, 

procedures, and guidance documents submitted in the application; however, only those policies 

and directives describing how the MML will manage its RCP will be incorporated into the MML 

as a license condition. 

Note: When submitting documents, the applicant may use the following guidelines for 

procedures, directives, and guides. If NRC guidance documents are adopted in their entirety, 

they only need to be referenced. Other NRC guidance documents that need to be modified to 

reflect the unique characteristics of the applicant’s program should be provided in their entirety. 

New procedures or guidance developed by the applicant also should be included in its entirety. 

Response from Applicant: 

 Provide management’s written commitment to follow NRC regulations. 

 Confirm that permitting and inspection programs will be implemented in accordance with 

NRC licensing and inspection criteria (i.e., NRC regulations, policies and guides), or 

submit any alternative procedures. 

 Submit all policies, procedures, directives, and guidance developed that will be used to 

manage the RCP pursuant to NRC regulations, policies, and guidance.4

 Specifically identify those NRC policies, procedures, and guidance documents that will 

be adopted in their entirety into the RCP.5

 Provide procedures to ensure that the RCP is updated as NRC guidance is changed, 

and that the staff is trained in current NRC guidance. 

5.10.5 Updating of Radiation Control Program Documents 

The RCP should establish procedures for appropriate and timely updating of MML internal 

guidelines and requirements to ensure conformance with revisions to NRC regulations, policies, 

and guidance. 

 

4

The NRC will review the policies, procedures, and guidance submitted in the application; however, only those 

policies and directives describing how the MML will manage its RCP will be incorporated into the MML in a 

license condition. 

5

Although audit, permitting, inspection, enforcement, incident response, emergency response, and allegation policies, 

procedures, and guidance are discussed in more detail in other sections of this NUREG, the documents associated 

with the management of these programs should be submitted in this section of the application document. 
5-18 

The applicant should describe the process for review and approval of changes to procedures 

and documents. The process should include provisions for submitting updated documents to 

the NRC for review and license amendment if the document is specifically referenced in the 

MML or causes a material change in the MML policies and procedures. 

Response from Applicant: 

 Describe the process for review and approval of changes to RCP procedures 

and documents. 

5.10.6 Management Support and Radiation Control Program Structure 

An MML authorizes the receipt, possession, distribution, use, transportation, transfer, and 

disposal of NRC-regulated radioactive material (e.g., byproduct, source, and special nuclear 

material) at permittee locations. As discussed in Section 5.7.1, “Senior Management,” the 

applicant’s senior management is responsible for the RCP. Therefore, senior management 

must commit to and provide for sufficient financial resources (i.e., funds, equipment, personnel, 

materials) to support the RCP at all levels. In addition, senior management should delegate in 

writing to the MRSC and the RCPD sufficient authority, organizational freedom, and 

management prerogative to communicate with and direct MML personnel at all levels regarding 

NRC regulations, MML provisions, and permit conditions. The MRSC provides regulatory 

oversight of all NRC-licensed radioactive material used by the licensee and its permittees on 

behalf of senior management and acting through the RCP office. 

The applicant should have sufficient resources to conduct an MML program effectively. The 

applicant should ensure that the RCPD has access to the highest levels of MML management 

with a sufficient level of financial control for the implementation of the program. This includes 

the availability of sufficient funds to support program implementation for areas such as 

the following: 

 travel-related costs necessary to conduct an effective permit compliance program, 

including, but not limited to, pre-permitting site visits, routine inspections, security 

inspections, follow-up or special inspections, and responses to incidents and 

other emergencies 

 training and qualification programs 

 instrumentation and other equipment to support the RCP 

 administrative costs 

 laboratory costs 

 laboratory services 

 computer, software, and word processing support 

 telecommunications, including internet, telephone, or video 

 vehicles 
5-19 

 office equipment 

 financial assurance for decommissioning sites 

 any indirect costs (e.g. resources used for non-MML activities) 

The RCP should be supported with sufficient staffing and technical expertise. The applicant’s 

overall radiation management structure should ensure that the RCPD has administrative control 

over the program staff and elements and has access to the highest levels of MML management 

for program support. There should be effective communication between the permittees and 

the RCPD. 

The application should include an organizational chart depicting the licensee’s management 

structure, reporting paths, flow of authority, control of finances, and location of all RCP 

management and staff. 

Response from Applicant: 

 Management commitment that the applicant will continue to provide sufficient operating 

funds to support the MML program elements. 

 Describe the lines of communication and administrative control between the permittees, 

RCP, and MML management. 

 Delegate in writing to the MRSC and the RCPD sufficient authority, organizational 

freedom, and management prerogative to communicate with and direct MML personnel 

at all levels regarding NRC regulations, MML provisions, and permit conditions. 

5.10.7 Radiation Control Policies–Administrative Controls and Provisions 

In accordance with 10 CFR 30.33, the applicant’s equipment and facilities must be adequate to 

protect health and minimize danger to life or property. Further the applicant must be qualified 

by training and experience to use licensed material for the purpose required in such manner as 

to protect health and minimize danger to life or property. The applicant should develop and 

implement written administrative policies. These policies should be clear, specific, and detailed 

enough to demonstrate that the applicant has sufficient processes in place, with senior 

management support, to implement the RCP. At a minimum, the policies should address 

the following: 

 organization and management, including program authorities and responsibilities 

 communications between the MML and the NRC 

 communications between permittees, RCP staff, and MML senior management 

 implementation of program elements 

 document control, retrieval, and recordkeeping 

 information dissemination 

 material control, procurement, and accounting 

 management review, quality controls, and audit program 

 corrective action program 

 training and qualification program for staff, including staff selection 

 other program elements essential to the successful implementation of the RCP 
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Response from Applicant: 

 Submit policies related to the administrative controls and provisions listed previously to 

demonstrate that the applicant has sufficient processes in place, with adequate senior 

management support, to implement the RCP. At a minimum, policies should address 

the following: 

− organization and management, including program authorities and responsibilities 

− communications between the MML and the NRC 

− communications between permittees, RCP staff, and MML senior management 

− policy for implementation of program elements 

− document control, retrieval, and recordkeeping 

− information dissemination 

− material control, procurement, and accounting 

− management review, quality controls, and audit program 

− training and qualification program for staff, including staff selection 

− other program elements essential to the successful implementation of the RCP 

5.10.8 Master Radiation Safety Committee Responsibilities 

The authority of the MRSC is contained in the delegation of authority for the MRSC signed by 

the applicant’s highest level of management. The delegation of authority was discussed in 

Section 5.7.1. The composition and the responsibilities of the MRSC were discussed in 

Section 5.7.2, “The Master Radiation Safety Committee.” 

Responsibilities of the MRSC should include, but are not limited to, the following: 

 establishing procedures for procurement, acquisition, use, security, control, and 

accountability of NRC-regulated radioactive material (e.g., byproduct, source, and 

special nuclear material) (see Section 5.10.20, “Security Program for Category 1 and 

Category 2 Radioactive Material” for additional guidance) to ensure compliance with 

the MML 

 managing and overseeing the MML 

 monitoring the performance of the RCP and the RCPD, and auditing the implementation 

of the RCP 

 advising senior management of the results of the MRSC audits and program reviews 

 ensuring that adequate resources are provided to implement the RCP, including 

implementation of permittee radiation safety programs 

 ensuring that adequate resources are provided for the training of MRSC, RCP, and 

permittee staff 

 ensuring that permitting and inspection staff is appropriately qualified, as described in 

IMC 1248 or an equivalent training and qualification program 

 maintaining records under the MML 
5-21 

 reviewing permit applications and recommending action to be taken by the chairperson 

or his/her designee 

 meeting quarterly with an established quorum (i.e., chairperson or his/her designee, 

RCPD, and two-thirds of the remaining membership) to review the activities of the RCP 

 maintaining a current list of quantities, uses, and locations where radioactive material is 

received, possessed, used, or stored 

 ensuring that inspections are conducted to assess permittee compliance with the 

provisions of the license, NRC regulations, and the specific permits 

 establishing enforcement policies and procedures 

 advising senior management and the NRC of all non-compliance items potentially 

categorized at severity levels I, II, or III, as identified in the NRC enforcement policy 

 providing copies of permits and inspection reports to the appropriate NRC regional office 

 requesting assistance from appropriate individuals and licensee organizations when 

necessary to assist the MRSC in the execution of its responsibilities 

 establishing technical committees to extend staff capabilities for unique or technically 

complex problems 

 establishing decommissioning policies and procedures 

 conducting, at least annually, a review of the radiation protection program and 

implementation, pursuant to 10 CFR 20.1101(c) 

The application should include the committee procedures that address each of these listed 

items, the written delegation of authority for the MRSC, and the established quorum 

requirements (i.e., chairperson, RCPD, and two-thirds of the remaining membership). The 

applicant should also describe the criteria under which it will obtain assistance from other 

subject matter experts and list any current subject matter experts or consultants that it uses to 

support the MRSC. 

Response from Applicant: 

 Provide organizational and procedural manuals that address each item in 

Section 5.10.8. 

Note: If you describe how you will meet one of the previously listed responsibilities in an 

organizational or procedural manual that is more appropriately provided in response to another 

section of this NUREG, you may simply identify the other section of your application where the 

information is found. 
5-22 

 Provide the delegation of authority from the highest level of management given to the 

MRSC, delineating its authority to oversee the licensed program and its responsibility for 

control and direction of the RCP and the RCPD. 

Note: The delegation of authority should state the MRSC’s authority to suspend or terminate 

activities based on poor performance or violation of safety standards. 

 Provide the MRSC’s composition and responsibilities. 

 Describe the criteria under which the MRSC will obtain assistance from other subject 

matter experts. 

 List any current subject matter experts or consultants used to support the MRSC. 

5.10.9 Radiation Control Program Director Responsibilities 

The application should include a copy of the written delegation of authority from senior 

management to the RCPD and a description of his/her responsibilities. Documentation should 

also show that the RCPD has access to the highest levels of MML management and should 

include a description of the RCPD’s level of administrative and financial control over the RCP. 

The responsibilities and authorities of the RCPD include, at a minimum, the following: 

 managing and controlling the RCP 

 conducting day-to-day operations of the RCP and issuing permits in accordance with 

procedures approved by the MRSC 

 serving as the routine point of contact between the MML and the NRC for matters 

concerning the MML 

 informing the MRSC and highest level of management regarding the status of the RCP 

 implementing the MRSC’s enforcement sanctions 

 stopping work activities that may pose undue risk or hazard, or may violate conditions of 

the license or NRC regulations 

 reviewing all radiological incidents and recommending corrective actions to the MRSC 

Response from Applicant: 

 Provide a copy of the written delegation of authority from the highest level of 

management to the RCPD. 

 Provide a description of the RCPD’s responsibilities. 

 Provide documentation to show that the RCPD has access to the highest levels of MML 

management. 

 Describe the measure of administrative and financial control over permitting and 

inspection personnel. 
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5.10.10 Permitting and Inspection Staff 

The MML permitting and inspection staff is responsible for, but not limited to, the following: 

 providing guidance to MML prospective permittees in the preparation of requests 

for permits 

 providing content of NRC generic communications to permittees in a timely manner 

 reviewing permit applications for completeness and compliance with current NRC 

regulations, policies, and guidance 

 preparing permits and forwarding to the MRSC (or delegate) for review and approval 

 performing inspections to assess compliance with NRC regulations and provisions of the 

MML and specific permits 

 preparing reports of inspection results and forwarding reports of non-compliance to 

the MRSC 

 conducting pre-permitting site visits 

 responding to incidents 

 providing decommissioning oversight 

The applicant should describe how the staff will manage the day-to-day operations of the RCP. 

The description should include, but not be limited to, the following: 

 responding to events at permittee facilities 

 maintaining uniformity of program implementation 

 maintaining internal communications 

 ensuring consistency of guidance provided to permittees 

 providing training to RCP staff 

 monitoring and evaluating RCP staff performance 

Response from Applicant: 

 Describe the duties of the permitting and inspection staff. 

 Describe how the staff will manage the day-to-day operations of the RCP, and include 

the following: 

− responding to events at permittee facilities 

− maintaining uniformity of program implementation 

− maintaining internal communications 

− ensuring consistency of guidance provided to permittees 

− providing training to RCP staff 

− monitoring and evaluating RCP staff performance 
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5.10.11 Radiation Control Program Internal Procedures 

The RCP should establish written internal procedures. These internal procedures should 

ensure a high degree of uniformity and continuity in the applicant’s regulatory practices. In 

addition, these procedures should address internal processing of permit applications, inspection 

policies and procedures, decommissioning, and other functions required of the program. 

The internal procedures should ensure the following: 

 The MML satisfies NRC requirements and criteria. 

 The MML complies with its NRC license and the commitments and procedures that are 

incorporated in the license. 

 The MML staff performs its duties as required. 

The RCP staff should provide quarterly reports through the RCPD to the MRSC on the status of 

the program, as well as an annual report on the audit of the program that includes the following: 

 overall conduct of the program 

 result of the program performance compared to regulatory requirements 

and commitments 

 review of permitting actions, inspection reports, response to events or incidents, 

enforcement actions, and decommissioning 

Response from Applicant: 

 Confirm that written internal procedures have been developed that, at a 

minimum, address the functions in Section 5.10.11, “Radiation Control Program 

Internal Procedures.” 

5.10.12 Management and Master Radiation Safety Committee Audits 

The MRSC should be fully aware of the operations and activities of the RCP. The MRSC 

should conduct audits and evaluations of the RCP’s performance. Results of the MRSC’s audit 

and program reviews should be reported to senior management to allow for timely and proactive 

remedial actions sufficient in scope to ensure compliance with NRC regulations and license 

conditions. At a minimum, the MRSC should report summary audit results and significant 

program outcomes such as escalated enforcement actions to senior management at least 

annually. An MML may also consider establishing MRSC subcommittees to evaluate and audit 

those areas of the program within their areas of expertise. 

Audits of the inspectors and permit reviewers should be conducted on at least an annual basis. 

Guidelines should be established for evaluating inspector and reviewer performance, including 

annual field evaluations for inspectors by the RCPD or inspection staff supervisor with results 

provided to the MRSC. Inspectors should demonstrate competence in evaluating health and 

safety problems and in determining compliance with NRC regulations. Inspectors should 

demonstrate an understanding of regulations, inspection guides, and policies before conducting 
5-25 

inspections independently. The MRSC should establish a system similar to the NRC’s 

qualification journal system found in IMC 1248. 

The MML application should contain a description of senior management MRSC oversight and 

the mechanisms used by the MRSC to ensure that it is aware of NRC regulations, the 

provisions of the license, and the compliance status of the RCP. This oversight may include 

independent audits of the program, frequent meetings with the MRSC, or periodic site visits of 

selected permittees. 

Permit reviewers should demonstrate an understanding of regulations, licensing policy and 

guidance directives, and permitting practices before reviewing and issuing permits 

independently. A sampling of each permit reviewer’s actions should be reviewed to assess 

performance and assure appropriate and consistent use of policies and guides. 

Response from Applicant: 

 Describe MRSC oversight and the mechanisms used to ensure awareness of NRC 

regulations, the provisions of the license, and the compliance status of the 

applicant’s RCP. 

 Provide a copy*6

 of the audit program used by the MRSC on behalf of senior 

management to audit the performance of the RCP, the RCPD, and the inspection and 

permitting staff, and update senior management as needed. 

 Describe how inspectors demonstrate competence in evaluating health and safety 

problems and in determining compliance with NRC regulations. 

 Describe how inspectors demonstrate an understanding of regulations, inspection 

guides, and policy practices before conducting inspections independently. 

 Describe how permit reviewers demonstrate competence in reviewing applications 

for permits. 

 Describe how reviewers demonstrate an understanding of regulations, licensing policy 

and guidance directives, and permitting practices before reviewing and issuing 

permits independently. 

5.10.13 Permitting Procedures 

The applicant should include copies of its permitting procedures, policies, and guidance. If the 

applicant commits to using NRC licensing procedures, policies, and guidance, it may list those 

NRC documents used and provide only those licensee documents that differ from NRC 

licensing procedures, policies, and guidance. The applicant should commit to updating its 

permitting guidance as it receives updates to the NRC licensing guidance. The applicant should 

provide specific timeliness goals for issuing permits and updating its licensing guidance as 

updates are received from the NRC. 

 

6

Throughout this document, descriptive items that will not be incorporated into the license as a requirement are 

indicated by a single asterisk (*); see the introduction to Section 5 for more information. 
5-26 

In addition, the application should contain a description of the RCP’s procedures to assess 

the essential elements of permittee applications that meet current regulatory guidance for 

the following: 

 descriptions of isotopes and quantities to be used 

 qualifications of persons who will use material 

 assurance that persons using material are either the MML’s employees or 

contract employees 

 facilities and equipment 

 assurance that facilities and sites are controlled by the MML’s Federal agency 

 operations, security, and emergency procedures 

 minimization of contamination 

To establish the basis for permitting actions, submitted information should document the 

isotopes, forms, quantities, authorized uses, and permissive and restrictive conditions and be 

readily available for audit during pre-permitting visits. Before permit renewal, the RCP should 

ensure that supporting information in the file reflects the current scope of the permitted program. 

Internal permitting guides should include checklists and policy memoranda consistent with 

current NRC licensing guidance. Permit applicants should be provided access to copies of 

applicable regulatory guidance by links to the RCP office or NRC Web sites. Compliance 

history should be considered when issuing modifications to existing permits or permit renewals. 

Standard permit conditions consistent with NRC standard license conditions should be used to 

expedite and provide uniformity in the permitting process. Custom conditions may be 

developed. However, any custom conditions that are less restrictive than applicable NRC 

requirements and criteria must be submitted to the regional office for further review 

and approval. 

The MML applicant should maintain files to allow efficient, accurate retrieval of information and 

documentation associated with the permitting program. 

Response from Applicant: 

 Commit to developing and implementing permitting procedures, policies, and guidance: 

− List NRC licensing procedures, policies, and guidance that will be used. 

− Provide for NRC review any documents that differ from NRC licensing procedures, 

policies, and guidance. 

 Provide standard permit condition(s) that are not consistent with NRC standard 

license conditions. 

 
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 Submit custom conditions that are less restrictive than applicable NRC requirements for 

further review and approval. 

 Provide specific timeliness goals for issuing permits and updating licensing guidance as 

updates are received from the NRC. 

 Describe document management procedures. 

5.10.14 Program To Minimize Contamination at Permittee Facilities 

In accordance with 10 CFR 20.1406, “Minimization of contamination,” the applicant must 

describe how facility designs and procedures for operation will (i) minimize, to the extent 

practicable, contamination of the permittees’ facilities and the environment; (ii) facilitate eventual 

decommissioning; and (iii) minimize, to the extent practicable, the generation of radioactive 

waste. Existing MMLs and their permittees and applicants for an MML should consider the 

importance of designing and operating their facilities to minimize the amount of radioactive 

contamination generated at a site during its operating lifetime and to minimize the generation of 

radioactive waste during decontamination. Licensees are also required by 10 CFR 20.1501, 

“General,” to make or cause to make such surveys as are necessary to comply with the 

regulations in 10 CFR Part 20 and are reasonable under the circumstances to evaluate the 

extent of residual radioactivity. This includes subsurface radioactivity. 

Applicants are also required to describe how they will conduct operations to minimize 

the generation of waste to facilitate future facility decommissioning in accordance with 

10 CFR 20.1406. Relevant guidance is available in Regulatory Guide 4.22, “Decommissioning 

Planning During Operations.” Applicants should include a description of the introduction of 

residual radioactivity into the site, including the subsurface, such as by slow, long-term leaks. 

Response from Applicant: 

 Describe how facility design and procedures for operation will (i) minimize, to the extent 

practicable, contamination of the permittees’ facilities and the environment; (ii) facilitate 

eventual decommissioning; and (iii) minimize, to the extent practicable, the generation of 

radioactive waste. 

5.10.15 Decommissioning of Permit Activities and Permit Termination 

This section focuses on the termination of the permit held by the permittee and 

decommissioning of the permittee’s site. This section does not address the termination of the 

MML that is addressed in Chapter 8, “Termination of the Master Materials License.” 

The applicant should describe its approach to permit termination and decommissioning 

conducted under the NRC decommissioning process. 

The NRC’s requirements for the decommissioning and termination of licenses for radioactive 

material are described in 10 CFR Part 30, “Rules of General Applicability to Domestic 

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

10 CFR Part 70, “Domestic Licensing of Special Nuclear Material”; and Subpart E of 10 CFR 

Part 20, “Radiological Criteria for License Termination.” Guidance for licensees and NRC staff, 

including guidance for implementing the requirement for preparing a decommissioning plan 

(DP), is found in NUREG–1757, Vols. 1, 2, and 3, “Consolidated Decommissioning Guidance.” 
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The applicant may either provide its permit decommissioning and termination procedures or 

commit that it will decommission its permitted facilities and terminate its permits in accordance 

with NRC regulations, policies, and guidance as provided in the LOU. Guidance for inspections 

of decommissioning activities is given in IMC 2602, “Decommissioning Oversight and Inspection 

Program for Fuel Cycle Facilities and Materials Licensees.” 

As outlined in the LOU, the NRC and the MML have shared responsibility for decommissioning 

and permit termination. Nothing in the following guidance describing the shared responsibility 

between the NRC and the MML precludes the MML from reviewing notifications, DPs, or other 

documents for their approval before transmitting them to the NRC. 

The NRC retains its authority to review and approve DPs on a case-by-case basis and in 

accordance with the guidance provided next. MML permit decommissioning and termination are 

subject to NRC regulations and should be conducted in accordance with NRC guidance in 

NUREG–1757. The MML must comply with the following notification and reporting directions: 

Initiation and Timeliness of Decommissioning 

The licensee must notify the NRC of changes in the operating status of its permittees in 

accordance with 10 CFR 30.36, “Expiration and termination of licenses and decommissioning 

of sites and separate buildings or outdoor areas”; 10 CFR 40.42, “Expiration and termination 

of licenses and decommissioning of sites and separate buildings or outdoor areas”; or 

10 CFR 70.38, “Expiration and termination of licenses and decommissioning of sites and 

separate buildings or outdoor areas,” when no principal activities7

 have been conducted under 

the permit for a period of 24 months. The notification must contain sufficient information for the 

NRC to determine whether a DP is needed and whether the NRC needs to review and approve 

the licensee’s plan. 

Decommissioning 

The MML is responsible for reviewing and approving simple decommissioning, that is, 

decommissioning activities that do not require a DP and involve unrestricted releases with or 

without screening criteria (i.e., decommissioning groups 1 and 2 as defined in NUREG–1757, 

Volume 1, Revision 2, Chapter 7, pp. 7-1 to 7-5). The NRC is responsible for reviewing and 

approving complex decommissioning activities, that is, activities that require a DP and involve 

either unrestricted or restricted release (i.e., decommissioning groups 3 to 7 as defined in 

NUREG–1757, Volume 1, Revision 2, Chapter 7, pp. 7-1 to 7-5). For complex 

decommissioning, before submitting DPs to the NRC, the MML should review DPs required by 

10 CFR 30.36, 10 CFR 40.42, or 10 CFR 70.38. 

Request for Extensions 

There are two relevant time schedules: one for initiating decommissioning and another for 

completion of decommissioning. In accordance with 10 CFR 30.36, 10 CFR 40.42, or 

10 CFR 70.38, the NRC may approve an extension of either time schedule. Pursuant to 

10 CFR 30.36(f), 10 CFR 40.24(f), and 10 CFR 70.38(f), the NRC may grant a request to extend 

 

7

“Principal activities,” (as indicated in 10 CFR 30.4) as used in 10 CFR Part 30, means activities authorized by the 

license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage 

during which no licensed material is accessed for use or disposal and activities incidental to decontamination or 

decommissioning are not principal activities. 
5-29 

the time period required to initiate decommissioning, provided the NRC determines that this 

relief is not detrimental to the public health and safety and is otherwise in the public interest. 

The time schedule for the completion of decommissioning can also be extended. A request for 

an extension or alternative schedule for completing decommission may be approved under 

10 CFR 30.36(i), 10 CFR 40.42(i), or 10 CFR 70.38(i). 

Completion of Decommissioning and Termination of the Permit 

The licensee is required by 10 CFR 30.36(j), 10 CFR 40.42(j), and 10 CFR 70.38(j) to certify the 

disposition of all licensed material and conduct a radiation survey of the premises where the 

licensed activities were carried out and submit a report of the results of the survey. This report 

is also known as the final status survey report (FSSR) submitted to the NRC for work completed 

under an NRC-approved DP. The NRC maintains the authority to review and approve FSSRs 

for complex decommissioning activities. The licensee should review the FSSR before 

submitting it to the NRC. Guidance for developing an FSSR is provided in NUREG–1757, 

Volume 2, Revision 1, Section 4.5, “Final status survey report.” 

Environmental Reviews 

The applicant should document that it recognizes that environmental reviews [i.e., National 

Environmental Protection Act (NEPA) reviews] for decommissioning would be conducted by the 

NRC using input provided by the licensee. The licensee does not have the authority to conduct 

the NEPA review (e.g., CATX/EA/EIS) for termination of a permit for any site under the MML. 

The NRC retains the responsibility for implementing this NEPA requirement. 

The licensee must develop a DP in accordance with 10 CFR 30.36(g)(1), 10 CFR 40.42(g)(1), 

and 10 CFR 70.38(g)(1) and the associated ER (10 CFR 51.45, “Environmental report,” and 

10 CFR 51.60, “Environmental report—materials licenses”) as necessary and propose the type 

of decommissioning for the NRC’s consideration. This is the input the NRC would need to 

conduct the appropriate environmental review. 

The licensee should follow the guidance described in NUREG–1757, Volume 1, in 

preparing the ER. The ER should provide sufficient detail commensurate with the extent 

of decommissioning needed and the final disposition of the site. NUREG–1748, 

“Environmental Review Guidance for Licensing Actions Associated with NMSS 

Programs,” provides further guidance on the development of ERs. 

Decommissioning Records 

In accordance with 10 CFR 30.51, “Records”; 10 CFR 40.61, “Records”; or 10 CFR 70.51, 

“Records requirements,” the MML must keep records showing the receipt, transfer, and disposal 

of radioactive materials. The NRC will review licensee records on a biennial basis to verify that 

the licensee’s records meet the intent of the regulations. 

Response from Applicant: 

 Provide decommissioning and permit termination procedures or commit that permit 

facilities will be decommissioned and permits will be terminated as described in 

NRC regulations, policies, the guidance in NUREG–1757, and the LOU. 

 Confirm that DPs for complex decommissioning sites described previously 
5-30 

will be submitted to the NRC for review and approval before commencing 

decommissioning activities. 

5.10.16 Financial Assurance 

In accordance with 10 CFR 30.35, the applicant must describe its program for establishing and 

maintaining adequate funds to decommission its permitted facilities. In cases involving multiple 

independent sites under a single license, the financial assurance and, if required, the 

decommissioning funding plan would have to delineate procedures and cost estimates for each 

facility or site. The licensee may treat each permittee’s facility independently and sum the 

amounts needed for each individual permittee to determine the total amount of financial 

assurance required to meet the regulations. Co-located permittees must be identified and the 

applicant’s plan for financial assurance provided for each location. Guidance is provided in 

NUREG–1757, Volume 3, “Consolidated Decommissioning Guidance.” 

Response from Applicant: 

 Describe how the decommissioning financial assurance requirements described in 

10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25 will be met. 

 Provide documentation that adequate funds to decommission all permitted facilities are 

established and maintained. 

5.10.17 Inspection and Enforcement Procedures 

The applicant should maintain an inspection program adequate to assess permittee compliance 

with NRC regulations, licensee requirements, and permit conditions. To ensure consistency 

between the NRC and the applicant’s inspection and enforcement programs, the licensee 

should maintain statistics to enable the MRSC or the NRC to assess the status and results of 

the inspection program on a periodic basis. This statistical information should include the 

number of inspections conducted, the number overdue, the length of time overdue, and 

inspection priority categories. The applicant should prepare an inspection plan that ensures that 

inspections are performed in accordance with IMC 2800, “Materials Inspection Program.” 

The applicant should establish an inspection priority system that, at a minimum, is equivalent to 

that described in IMC 2800. The applicant’s inspection guidance should be consistent with 

current NRC inspection guidance and provide technical guidance in the inspection of permitted 

programs. To ensure consistency, the written inspection program should establish a policy for 

conducting unannounced inspections, obtaining corrective action, following up and closing out 

previous violations, conducting interviews with workers and observing operations, conducting 

exit interviews with management, issuing appropriate notices of violations, and communicating 

health and safety problems. Independent survey measurements should be sufficient in number 

and type to ensure the permittee’s control of materials and to validate the permittee’s 

measurements. In addition, the licensee should have access to laboratory support capability to 

conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, 

or perform other necessary analyses on a priority established by the licensee. 

Findings of inspections should be documented for future use by licensee inspection staff and 

permittees. At a minimum, this documentation should include a description of (i) the scope of 

inspection, (ii) facts and data to substantiate all items of noncompliance and health and safety 

issues, (iii) the scope of the permittee’s programs, (iv) the substance of discussions with 
5-31 

permittee management and the permittee’s response, (v) the status of previous items of 

noncompliance, and (vi) the results of any independent survey measurements made by the 

inspector. Inspection documents forwarded to the permittee should describe the scope and 

results of the inspection, including identification of any items of noncompliance, health and 

safety issues, and areas of the permittee’s program that should receive special attention by 

permittee management. Corrective actions planned or taken by the permittee for items of 

noncompliance should be documented and retained in the permittee file for future evaluation by 

MML inspectors. 

The licensee should establish an enforcement program to ensure consistent assessment of the 

regulatory and safety significance of violations. To ensure uniform enforcement policies 

between MML and equivalent NRC licensees, the program should commit to following NRC’s 

enforcement policies, consistent with the legal authority of the MML. The program should 

include a description of the sanctions to be used and methods used for assessing the severity of 

violations and taking enforcement actions for the more severe violations. It should also include 

a process for notifying the NRC of any potential Severity Levels I, II, and III violations for 

possible NRC action. MML action against its permittees does not preclude the NRC from taking 

action against the MML, its permittees, or its employees. 

Response from Applicant: 

 Provide permit inspection procedures addressing the elements discussed in 

Section 5.10.17, “Inspection and Enforcement Procedures.” 

 Provide enforcement program procedures for assessing the severity of violations and 

taking enforcement actions for the more severe violations. 

 Provide procedures for documenting inspection findings and enforcement actions. 

5.10.18 Corrective Action Program 

Given the level of responsibility granted to an MML by the NRC to oversee permittees, the NRC 

recommends that the applicant for an MML develop and implement a corrective action program 

(CAP) that will assist the licensee in identifying and correcting safety-related conditions. A CAP 

would help in preventing violations and events that could impact the public health and safety 

and common defense and security and protection of the environment, and prevent recurrence of 

violations with similar root causes across all MML activities. A CAP should include elements 

that would enable the MML to do the following: 

 Establish an environment that encourages workers to identify and report safety or 

security concerns. 

 Review the safety concerns in order to determine their significance. 

 Determine the appropriate level of investigation that may be needed and whether or not 

to consider looking at the “extent of condition.” 

 Implement corrective action(s) in a timely manner. 

 Assess the effectiveness of corrective action(s) taken. 
5-32 

 Identify lessons learned and incorporate them back into the CAP. 

 Monitor and track CAP-related activities to completion. 

 Communicate CAP activities to all MML permittees. 

5.10.19 Incident/Emergency Response Procedures 

The applicant should develop procedures for responding to emergencies, events, or incidents, 

including, but not limited to, a security threat or event involving permitted material, medical 

events, spills, fires, release or loss of radioactive material, potential or actual overexposures, 

and contamination of personnel at permittee facilities. The applicant should describe its 

provisions for immediate response and handling of such incidents, including off-hours 

notification to appropriate licensee staff, state and local authorities, and when applicable, the 

NRC. The procedures should define the oversight responsibilities of the RCP management 

and staff, including actions to be taken by permittees. The procedures should identify the 

persons responsible for initiating response actions, conducting operations, and performing 

cleanup. Only qualified and experienced individuals should conduct decontamination and 

recovery operations. 

Additionally, when permittees request possession of radioactive materials in both unsealed and 

certain sealed forms in excess of specifically listed quantities, they must prepare an emergency 

plan. If the applicant determines that there is a need for an emergency plan by certain 

permittees pursuant to 10 CFR 30.32, the applicant must identify those permittees and submit 

copies of the approved emergency plans to the appropriate regional office. Guidance for this 

submittal is contained in Regulatory Guide 3.67, “Standard Format and Content for Emergency 

Plans for Fuel Cycle and Materials Facilities.” 

In accordance with 10 CFR Part 21, “Reporting of Defects and Noncompliance,” information on 

incidents involving failure of equipment must be provided to the agency responsible for 

evaluation of the device to assess possible generic design deficiency (e.g., the NRC and the 

U.S. Department of Health and Human Services, Food and Drug Administration). 
5-33 

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

Category 2 quantity of radioactive material must, 

 In accordance with 10 CFR 37.21(a), establish, implement, and maintain its access 

authorization program in accordance with the requirements of 10 CFR Part 37, Subpart B. 

 In accordance with 10 CFR 37.45, attempt to coordinate with their local law enforcement 

agency for responding to threats to a licensee’s facility 

 In accordance with 10 CFR 37.49 and 37.53, be able to monitor and immediately detect and 

assess any unauthorized entries into security zones, including those surrounding mobile 

devices. 

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

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

2 Quantities of Radioactive Material.”” Additional information regarding best practices for 

protection of risk-significant radioactive material is available in NUREG–2166, “Physical Security 

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

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

review and approval. 

Response from Applicant: 

 Provide incident/emergency response procedures, that address at a minimum, 

the following: 

− RCP management oversight responsibilities 

− initial response actions and responsibilities, including safety for RCP management 

and staff, and permittees 

− list of persons responsible for initiating response actions, conducting operations, and 

performing cleanup 

− precautions for people and property at permittee facilities 

− permittee facility and site access control and security 

− mechanisms and responsibilities for notifying RCP staff and external authorities 

− provisions for medical and offsite agency assistance 

− description of emergency response equipment available for use by the RCP 

office staff 

− need for onsite review of events 

− communications between the permittee facility and RCP 

− communications between the RCP office and the NRC 
5-34 

 Provide appropriate emergency plan(s) in accordance with 10 CFR 30.32, if applicable. 

5.10.20 Security Program for Category 1 and Category 2 Radioactive Material 

Licensees must ensure the security of Category 1 and Category 2 radioactive material. 

Note: The regulations in 10 CFR Part 37 apply to licensees that possess an aggregated 

Category 1 or Category 2 quantity of radioactive material, as specified in Appendix A to 

10 CFR Part 37. The requirements in 10 CFR 20.2207 for submitting National Source Tracking 

Transaction Reports (NSTTR) are applicable to those licensees that manufacture, transfer, 

receive, disassemble, or dispose of sealed sources containing a quantity equal to or greater 

than the Category 1 or Category 2 levels of radioactive material listed in Appendix E to 10 CFR 

Part 20. 

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

of Radioactive Material” 

In accordance with 10 CFR Part 37, licensees 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. 

Table 1 of Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR Part 37 

lists Category 1 and Category 2 threshold quantities of radioactive material. The applicant 

should refer to this table to determine whether its proposed activities would be subject to the 

10 CFR Part 37 requirements. 

Licensees authorized to hold Category 1 or Category 2 quantities of radioactive material must 

establish access authorization programs in accordance with 10 CFR Part 37, Subpart B. Before 

giving individuals unescorted access to such quantities of radioactive material, licensees must 

conduct prior background investigations of these individuals in accordance with 10 CFR 37.25. 

In accordance with 10 CFR 37.41(b), licensees must establish a security program designed to 

monitor and, without delay, detect, assess, and respond to any actual or attempted efforts to 

gain unauthorized access to Category 1 or Category 2 quantities of radioactive material. 

Per 10 CFR Part 37, Subpart D, licensees must provide for physical protection of Category 1 or 

Category 2 quantities of radioactive materials in transit. These requirements apply to licensees 

delivering such material to a carrier for transport, as well as cases in which licensees are 

transporting such material. Please note that the Subpart D requirements applicable to the 

transport of Category 1 quantities of radioactive material are more stringent than those 

applicable to Category 2 quantities. 

Applicants and licensees are required to implement the 10 CFR Part 37 security requirements 

before they take possession of an aggregated Category 1 or Category 2 quantity of 

radioactive material. 

In accordance with 10 CFR 37.41(a)(3), any licensee that has not previously implemented the 

Security Orders (i.e., orders issued by the NRC to require licensees to implement interim 

security measures) or been made subject to the provisions of 10 CFR Part 37, Subpart C, shall 

notify the NRC regional office specified in 10 CFR 30.6 in writing at least 90 days before 

aggregating radioactive material to a quantity that equals or exceeds the Category 2 threshold. 
5-35 

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

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

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

for protection of risk-significant radioactive material is available in NUREG–2166, “Physical 

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

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

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 

NSTTR to the NRC. The NSTTRs are maintained in the National Source Tracking System, a 

secure 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 the source activity 

decays enough to no longer be of concern. 

Response from Applicant: No response is required from an applicant or licensee. 

Note: In relation to security events involving a Category 1 or Category 2 quantity of radioactive 

material, notifications to the local law enforcement agency and the NRC, as well as subsequent 

reports to the NRC, must be made in accordance with 10 CFR 37.57 and 10 CFR 37.81, 

as appropriate. 

5.10.21 Procedures for Handling Allegations 

Handling allegations is a shared responsibility between the licensee and the NRC, and is 

addressed in the LOU. In accordance with 10 CFR 30.7, “Employee protection,” the applicant 

must establish a program for responding to employee radiation safety concerns that provides for 

timely investigation and response to these concerns. The program must also address the 

prevention of reprisals against employees for expressing their radiation safety concerns to 

management. The program should include a policy that encourages employees to bring forward 

any perceived radiological safety issues. The program should include procedures for training 

that clearly articulate the right of any employee to raise radiation safety concerns directly to the 

NRC, if desired. 

Allegations received by the NRC may be investigated by the NRC or referred to the licensee. 

The applicant should specify whether it will follow the NRC’s procedures for handling allegations 

(NRC Management Directive 8.8, “Management of Allegations”) or include equivalent 

procedures for handling allegations that are referred to or received by the licensee. 

The applicant should describe the closure process for the allegation, including addressing 

timeliness and the issuance of the response closure letter to the concerned individual (alleger). 

Response from Applicant: 

 Confirm that the NRC’s procedures for handling allegations will be used, or provide 

equivalent procedures for handling allegations that are referred to or received by 

the licensee. 

 Provide procedures for handling, documenting, investigating, and closing an allegation 

raised by a concerned individual. 
5-36 

 Provide a description of the training that will be provided to all employees to ensure that 

they understand their right to contact the NRC directly about radiation safety or 

regulatory issues. 

5.11 NRC Form 313, Item 11: Waste Management 

In accordance with the waste disposal requirements in 10 CFR Part 20, Subpart K, the applicant 

must describe the criteria for approving disposal of radioactive waste. 10 CFR Part 20, 

Subpart K provides the regulatory framework for various methods of waste disposal as well as a 

method for obtaining approval of proposed disposal procedures. The applicant should describe 

the criteria for approving disposal of radioactive waste under 10 CFR Part 20, Subpart K, with 

the exception of 10 CFR 20.2002 (the NRC retains responsibility for approving activities 

proposed under 10 CFR 20.2002 per the LOU). 

The applicant should describe the locations, conditions, and current status of former burial sites, 

whether controlled or uncontrolled; any active monitoring of the site; and the current condition of 

the burial site for permittees who were NRC licensees authorized before January 28, 1981, to 

bury radioactive material when 10 CFR 20.304, “Disposal by burial in soil,” authorized such 

burial. 10 CFR 20.304 was rescinded effective January 28, 1981 (45 FR 71761). This disposal 

method is no longer valid. 

Response from Applicant: 

 Describe the criteria for approving disposal of radioactive waste under 10 CFR Part 20, 

Subpart K, with the exception of 10 CFR 20.2002. 

 Describe the locations, conditions, and current status of former burial sites, whether 

controlled or uncontrolled; any active monitoring of the site; and the current condition 

of the burial site for permittees who were NRC licensees authorized before 

January 28, 1981, to bury radioactive material. A list of these legacy sites (i.e., burial 

sites) should be submitted to the NRC for tracking purposes upon the NRC’s request. 

5.12 NRC Form 313, Item 12: License Fees 

On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and write “Full Cost” 

in the box indicating the amount of the fee enclosed with the application. In regard to 

determining the fee amount, the applicant will need to contact the NRC. 

There may be additional annual fees for each Sealed Source Device Registration issued to 

the MML. 

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 the NRC’s toll free number, 

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

Fees.Resource@nrc.gov. 
5-37 

5.13 NRC Form 313, Item 13: Certification 

A representative of the Federal 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. 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 knowingly and willfully make a false statement or 

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

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

license and, therefore, will become binding regulatory requirements. 

6-1 

6 LICENSE AMENDMENTS 

It is the licensee’s obligation to keep the license current. If any of the information provided in 

the original application and incorporated by reference into license conditions 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. An exception 

may be provided in cases where the Letter of Understanding (LOU) allows for changes. For 

example, some LOUs may allow the master materials licensee to make administrative changes 

to various application documents without submitting a request to the U.S. Nuclear Regulatory 

Commission (NRC) for a license amendment insofar as the changes do not decrease the 

effectiveness of the radiation safety program, do not result in less stringent requirements than 

NRC regulations, and the Master Radiation Safety Committee has reviewed and approved the 

changes prior to implementation. 

Applicants for license amendment should do the following: 

 Use the most recent guidance in preparing an amendment request. 

 Submit either an NRC Form 313 or a letter requesting amendment. 

 Provide the license number and docket number. 

7-1 

7 APPLICATIONS FOR EXEMPTIONS 

Licensees may request exemptions from U.S. Nuclear Regulatory Commission (NRC) 

regulations. The licensee must demonstrate that the exemption is authorized by law; will not 

endanger life, property, or the common defense and security; and is otherwise in the public 

interest. Licensees may also use existing exemptions provided in Title 10 of the Code of 

Federal Regulations (10 CFR) regulations if they meet the established criteria. 

Various sections of the NRC’s regulations address requests for exemptions 

(e.g., 10 CFR 19.31, “Application for exemptions”; 10 CFR 20.2301, “Applications for 

exemptions”; 10 CFR 30.11, “Specific exemptions”; 10 CFR 37.11, “Specific exemptions”; 

10 CFR 40.14, “Specific exemptions”; and 10 CFR 70.17, “Specific exemptions”). These 

regulations state that the NRC may grant an exemption, acting on its own initiative or on an 

application from an interested person. 

Exemptions are not intended to revise regulations or to apply to large classes of licensees and 

are generally limited to unique situations. Requests for exemptions submitted to the NRC must 

identify the regulation for which the exemption is being requested and include a justification for 

the requested exemption. 

Unless the NRC has granted an exemption in writing, licensees must comply with all 

applicable regulations. 

8-1 

8 TERMINATION OF THE MASTER MATERIALS LICENSE 

This section focuses on the termination of the license held by the Master Material Licensee 

(MML) as a licensed entity and the transfer to the U.S. Nuclear Regulatory Commission (NRC) 

of permits that have not been terminated. This section does not address the termination of 

individual permitted sites or activities under the MML that are addressed in Section 5.10.15, 

“Decommissioning of Permit Activities and Permit Termination.” 

The licensee must do the following: 

 When proposing termination of the MML, the licensee should: 

− Notify the NRC, in writing of the MML proposed termination of its licensed operations 

and include the reason for terminating the MML. 

− Notify the NRC of the termination status of all of the MML permits by either 

 documenting that all MML permits have been terminated 

 documenting those permits that have been terminated and transferring the 

remaining active permits to the NRC 

− Document the justification for not terminating permits that are proposed to be 

transferred to the NRC (e.g., need for continued permit activities). 

− If active permits are not being transferred at this time, document proposed plans and 

schedule for permit transfers to the NRC. 

− Propose termination of the MML Letter of Understanding. 

 Before completing termination of the MML, the licensee should do the following: 

− Obtain NRC approval of the plans, schedule, and termination of the MML. 

− Transfer all records to the appropriate regional office that has the oversight for 

the MML for retention, including records for specific permits that have not 

been terminated. 

− During the period of time between the request for termination and the termination of 

the license, coordinate activities with the NRC so that there is continued protection of 

the public health and safety. 

 Before completing termination of the MML, the licensee must submit a certification 

of disposition of materials that is relevant to the termination of the MML for 

the organization. 

 Before completing termination of the MML, the NRC will do the following: 

− Communicate with the permittees to explain the reassertion of NRC authority and the 

present fee structure. 
8-2 

− Issue letters to the U.S. Department of Labor and other Federal agencies advising 

the various agencies of the effective date of the termination of the license. 

− Obtain from the MML a computer printout listing of all permittees. The NRC should 

prepare and issue a letter notifying each permittee of the termination, reassertion of 

the NRC’s authority, and appropriate information for obtaining an NRC license. Note 

that all permits must be transferred and licensed by the NRC before the MML will 

be terminated. 

− Coordinate with the MML to ensure that all the files are transferred to the NRC in an 

expeditious manner. 

− As a final step and after all termination or transfer activities are completed and 

confirmed by the NRC, the MML financial instrument (for financial assurance) will be 

cancelled and returned by the NRC. If the NRC approves the planned transfer of 

some permitted MML sites to a new licensee under a specific NRC license, NRCapproved financial assurance for each site must be completed by the new licensee 

before transfer. After the site(s) is transferred, the MML financial instrument will be 

cancelled and returned to the MML. 

− Renewed Future Interest in Obtaining an MML: A Federal agency that has had an 

MML terminated by the NRC may, at a later date, express interest in obtaining a new 

MML. The applicant should be treated as any other applicant interested in obtaining 

an MML, and the guidance in this document should be followed. 

Should MML termination be planned by the licensee, the process is likely to be complex and to 

require substantial discussion and coordination between the licensee and the NRC. Such 

coordination should occur both before notification as well as during the termination process so 

that an acceptable plan may be developed that will address the unique circumstances of the 

MML and its subsequent termination. In accordance with 10 CFR 30.36, 10 CFR 40.42, and 

10 CFR 70.38, “Expiration and termination of licenses and decommissioning of sites and 

separate buildings or outdoor areas,” the MML continues in effect, with respect to possession of 

byproduct, source, and special nuclear material until the NRC notifies the MML in writing that 

the license is terminated. 

Response from Applicant: The applicant is not required to submit a response to the NRC 

during the initial application. However, in its application, the licensee must acknowledge the 

termination process outlined previously; and acknowledge that its obligations in this matter 

begin when the license expires or at the time the licensee ceases operations, whichever is 

earlier. The licensee’s obligations are to undertake the necessary decommissioning activities, 

to submit NRC Form 314 (“Certificate of Disposition of Materials”) or equivalent information, and 

to perform any other actions summarized previously. 

Reference: NRC Form 314 is available at http://www.nrc.gov/reading-rm/doc-collections/forms. 
APPENDIX A 

U.S. NUCLEAR REGULATORY COMMISSION FORM 313

A–1 

U.S. Nuclear Regulatory Commission Form 313 

Please use the most current version of this form, which may be found at: 

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

APPENDIX B 

SUGGESTED FORMAT FOR PROVIDING INFORMATION REQUESTED IN 

ITEMS 2, 3, AND 5 THROUGH 11 OF U.S. NUCLEAR REGULATORY 

COMMISSION FORM 313 

 B–1 

Suggested Format for Providing Information Requested in 

Items 2, 3, and 5 through 11 of U.S. Nuclear Regulatory Commission 

Form 313 

Instructions: 

If there is a box available in the column labeled “Yes,” then you may check that box if you are 

agreeing to the commitment described in the “Suggested Response.” 

If you check a box in the column marked “Description Attached,” then you must provide that 

information on separate sheets. 

I. Contents of Application (2.0) 

A. Letter of Understanding (2.6) 

Item 

No. Suggested Response Yes 

Description 

Attached 

Submit a draft Letter of Understanding (LOU) that defines and describes 

the division of responsibilities and the requirements for coordination 

between the applicant and the U.S. Nuclear Regulatory Commission 

(NRC), utilizing Appendix C as an example. The LOU will be finalized 

and signed by the applicant and the NRC prior to issuance of a new 

license.

[ ] 

B. Permitting and Enforcement History (2.7) 

Item 

No. Suggested Response Yes 

Description 

Attached 

Describe regulatory performance in licensing, inspection, enforcement, 

and centralized experience in management oversight and coordination 

of licensing and inspection efforts for the previous 5 years. 

 

[ ] 

 
 B–2 

C. Contents of Item 3 and Part of Item 2 of NRC Form 313 

Item 

No. Suggested Response Yes 

Description 

Attached 

2. NAME AND MAILING ADDRESS OF APPLICANT (5.2)

Confirm whether the docketed permittee files for the MML will be 

located at the Radiation Control Program (RCP) Office. 

[ ] 

NRC Form 313, Item 3: Address(es) Where Licensed Material Will Be Used or 

Possessed (5.3) 

 Provide a current list of permittees, locations, and program code(s). 

 Identify permittees that will be authorized to use radioactive material at 

temporary jobsites. 

 Identify permittees that intend to use radioactive material in field studies. 

 Identify permittees that intend to use radioactive material at facilities and sites, other 

than temporary jobsites, that are not located at the MML’s federally controlled facilities. 

D. Contents of Items 5 through 11 of NRC Form 313 

Item 

No. Suggested Response Yes

Description 

Attached

5. RADIOACTIVE MATERIAL (5.5)

 Identify the licensed material to be possessed by isotope class 

(e.g., byproduct, source, or special nuclear material); chemical or 

physical form; quantity (e.g., in curie or millicurie), etc.; and general 

areas of use (e.g., research and development activities, industrial 

activities, self-contained irradiators, instrument calibrators, radiography, 

or medical applications). 

 Identify by manufacturer and model number all sealed sources used in 

devices (e.g., self-contained irradiators, panoramic irradiators, 

instrument calibrators, radiography cameras, etc.). Specify whether the 

device(s) is/are registered or not registered in accordance with Title 10 

of the Code of Federal Regulations (10 CFR) Part 32.210. 

 Identify permittees that may possess quantities of materials requiring 

financial assurance or an emergency plan. 

 

[ ] 

[ ] 

[ ] 

 
 B–3 

Item 

No. Suggested Response Yes

Description 

Attached

6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED (5.6)

 Explain why an MML is needed. 

 Describe in general terms the purposes for which licensed material will 

be used. 

 State whether you intend to use or approve sealed sources other than 

those that have been registered with the NRC’s Sealed Source and 

Device Registry, and describe the training and experience of individuals 

responsible for reviewing applications for use of these materials. 

 Identify any uses that are not identified as a categorical exclusion 

(CATX) in 10 CFR 51.22 (including field studies deliberately releasing 

licensed material to the environment), and provide information needed 

for specific authorization. 

 Provide sufficient information about field studies where there is no 

planned deliberate release of radioactive material to the environment for 

the NRC to determine whether a CATX is appropriate. 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 
 B–4 

Item No. Suggested Response Yes Description 

Attached

7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY 

PROGRAM AND THEIR TRAINING AND EXPERIENCE (5.7)

Senior Management (5.7.1)

 Provide an organizational chart depicting the licensee’s 

management structure, reporting paths, flow of authority, control of 

finances, and geographical location of all management and staff 

components of the RCP. 

 Describe established management controls and oversight used to 

ensure that permitted activities are properly conducted. This should 

include senior management’s established administrative controls 

and provisions relating to organization and management, including 

management review necessary to ensure adequate protection of 

public health, safety and security, and the environment. 

 Provide senior management’s written delegations to the Master 

Radiation Safety Committee (MRSC) and RCPD providing for 

sufficient authority, organizational freedom, and management 

prerogative to communicate with and direct MML personnel at all 

levels regarding NRC regulations, MML provisions, and permit 

conditions. 

 Provide the point of contact as the liaison to the NRC MML project 

manager (PM), and describe the expected types of interactions and 

exchanges of information, including both formal and informal 

communication mechanisms. 

 Confirm and describe senior management commitment to devote 

sufficient financial resources (e.g., funds, equipment, personnel, 

materials) to support the RCP at all levels. 

 Describe the senior management oversight and mechanisms used 

by management to ensure adequate control over MML activities,

such as using the MRSC to audit and evaluate overall program 

implementation. The senior management oversight activities should 

include 

− membership and active participation in MRSC meetings 

− oversight of RCPD and support staff 

− annual audits of the program to ensure safe operations, 

regulatory compliance, and consistency with the NRC’s policies 

and procedures 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 
 B–5 

Item No. Suggested Response Yes Description 

Attached

Master Radiation Safety Committee (5.7.2) 

 Describe the composition, duties, and functions of the MRSC. 

 Identify the chairperson and individual members of the MRSC by 

position title and job description. 

 Describe the duties of the MRSC chairperson, and provide a 

commitment that the chairperson or management representative 

has access to financial and budgeting officials consistent with the 

agency’s usual funding methods and procedures. 

 Describe the duties of the RCPD. 

Note: The identities of the members of the MRSC are descriptive 

information and are not incorporated in the license. If there are 

significant changes to actual membership of the MRSC (i.e., functionally 

significant changes in position titles and job descriptions), the NRC 

should be notified. Notification is not needed for reorganizations that 

change the position titles without changing the basic radiation safety 

responsibilities of the position or for the reassignments of new 

individuals into designated positions. 

 

[ ] 

[ ] 

[ ] 

[ ] 

 

Radiation Control Program Director (5.7.3) 

 Provide the minimum generic qualifications of the RCPD. 

 Identify the individual designated as the RCPD. 

 Provide documentation on the education, training, and experience 

demonstrating the individual designated as the RCPD is qualified to 

manage the RCP.

Note: The information identifying the individual designated RCPD and 

his/her qualifications is descriptive information and is not incorporated in 

the license. If the RCPD changes, then the NRC should be notified. 

 

[ ] 

[ ] 

[ ] 
 B–6 

Item No. Suggested Response Yes Description 

Attached

Other Radiation Control Program Staff (5.7.4) 

 Provide a list of the RCP office staff positions by job title, 

description, and number of individuals for each position. 

 Describe procedures and criteria for ensuring that members of the 

RCP office staff are adequately qualified. (These procedures are 

part of the RCP procedures generically addressed in Section 5.10.4, 

“Regulatory Conformance.”) 

 Provide management commitment to training and continued training 

of program staff in accordance with Inspection Manual Chapter 1248 

or equivalent program for training and qualification of staff. 

Note: Listing the RCP staff positions is descriptive information and is 

not incorporated into the license. If the number of RCP staff positions 

changes or significant changes are made in job descriptions, the NRC 

should be notified.

 

[ ] 

[ ] 

[ ] 

8. TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING 

RESTRICTED AREAS (5.8) 

 Describe the training and experience required of individuals who will 

be required to work in, inspect, or frequent any restricted areas 

included under the MML. 

 

[ ] 

9. FACILITIES AND EQUIPMENT (5.9) 

 Provide the location and description of all facilities used by the MML 

to carry out its activities. 

 State in the application where all docketed and required files and 

records will be maintained. 

 Provide a list and description of the laboratory equipment, such as 

radioactivity counting systems, portable radiation survey meters, air 

monitoring, or other devices necessary for conducting the inspection 

of permittees. 

Note: The information on the locations, facilities, and laboratory 

equipment is descriptive information and is not incorporated in the 

license. If the location and facilities used by the RCP staff change, 

notify the NRC. Notification is not needed for changes to upgrade 

equipment, provided that the applicant maintains the same level of 

coverage described in the application. 

[ ] 

[ ] 

[ ] 
 B–7 

Item No. Suggested Response Yes Description 

Attached

10. RADIATION CONTROL PROGRAM–AN OVERVIEW (5.10.1) 

 Provide a concise narrative overview description of the RCP. 

 Describe the centralized administrative controls and provisions for 

− organization and management structure 

− procedures 

− recordkeeping 

− material control and accountability 

− management review 

 Describe the permitting, inspection, enforcement, and 

decommissioning programs. 

 Describe the incident response and allegations programs. 

 Describe the staff training and qualification programs. 

 Commit to updating procedures to maintain consistency with NRC 

policies, procedures, and guidance. 

Note: While both the description of the written administrative control 

processes and the program elements, such as permitting, inspection, 

enforcement, incidents, allegations, training, and decommissioning, 

should be concise, the descriptions should also contain sufficient detail, 

clarity, and specificity in order to describe how management oversight 

for the program activities will be carried out and how the program 

functions. All elements in the narrative overview description of the RCP 

should concisely address the following (a narrative overview description 

is not needed when NRC guidance documents are included by 

reference in the RCP because these documents were adopted in their 

entirety): 

 program authorities and responsibilities 

 communications 

 quality control surveillance 

 program audits 

 procurement 

 staff selection and qualification 

 information dissemination, document control, and retrieval 

 other considerations essential to the successful implementation of 

the RCP 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 
 B–8 

Item No. Suggested Response Yes Description 

Attached

Previous Licenses (5.10.2) 

 List the radioactive materials licenses the applicant wants to include 

in the MML. 

Note: The list of materials licenses to be included in the MML is 

descriptive information to assist the NRC in accurately terminating 

licenses and is not incorporated in the license. The regions and Office 

of Nuclear Materials Safety and Safeguards are responsible for 

transferring NRC license docket files to the primary regional office in 

which the MML will be based. The MML PM should be kept informed of 

these activities and oversee the coordination and disposition of the NRC 

license docket files. The NRC license docket files may be maintained in 

the NRC regional office, transferred to the MML, or archived. 

Material Control and Accountability (5.10.3) 

 Describe the administrative controls and provisions relating to 

materials control and accountability. 

 Describe the inventory control and accountability method of licensed 

material. 

 Provide a statement that “We will develop, implement, and maintain 

procedures for ensuring accountability of licensed materials at all 

times.” 

 Provide a statement that “We will comply with the NSTS reporting 

requirements as described in 10 CFR 20.2207, ‘Reports of 

transactions involving nationally tracked sources’.” 

Regulatory Conformance (5.10.4) 

 Provide management’s written commitment to follow 

NRC regulations. 

 Confirm that permitting and inspection programs will be 

implemented in accordance with NRC licensing and inspection 

criteria (i.e., NRC regulations, policies, and guidance), or submit any 

alternative procedures. 

 Submit all policies, procedures, directives, and guidance developed 

that will be used to manage the RCP pursuant to NRC regulations, 

policies, and guidance. 

 Specifically identify those NRC policies, procedures, and guidance 

documents that will be adopted in their entirety into the RCP. 

 Provide procedures to ensure that the RCP is updated as NRC 

guidance is changed, and that the staff is trained in current NRC 

guidance. 

[ ] 

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[ ] 

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[ ] 
 B–9 

Item No. Suggested Response Yes Description 

Attached

Updating of Radiation Control Program Documents (5.10.5) 

 Describe the process for review and approval of changes to RCP 

procedures and documents. 

Management Support and RCP Structure (5.10.6) 

 Management commitment that the applicant will continue to provide 

sufficient operating funds to support the MML program elements. 

 Describe the lines of communication and administrative control 

between the permittees, RCP, and MML management. 

 Delegate in writing to the MRSC and the RCPD sufficient authority, 

organizational freedom, and management prerogative to 

communicate with and direct MML personnel at all levels regarding 

NRC regulations, MML provisions, and permit conditions. 

 

Radiation Control Policies–Administrative Controls and 

Provisions (5.10.7) 

 Submit policies related to the administrative controls and provisions 

listed previously to demonstrate that the applicant has sufficient 

processes in place, with adequate senior management support, to 

implement the RCP. At a minimum, policies should address the 

following: 

- organization and management, including program authorities 

and responsibilities 

- communications between the MML and the NRC 

- communications between permittees, RCP staff, and MML 

senior management 

- policy for implementation of program elements 

- document control, retrieval, and recordkeeping 

- information dissemination 

- material control, procurement, and accounting 

- management review, quality controls, and audit program 

- training and qualification program for staff, including 

staff selection 

- other program elements essential to the successful 

implementation of the RCP

 

[ ] 

[ ] 

[ ] 

[ ] 

[ ] 
 B–10 

Item No. Suggested Response Yes Description 

Attached

Master Radiation Safety Committee Responsibilities (5.10.8) 

 Provide organizational and procedural manuals that address each 

item in Section 5.10.8. 

Note: If you describe how you will meet one of the listed responsibilities 

in an organizational or procedural manual that is more appropriately 

provided in response to another section of this NUREG, you may simply 

identify the other section of your application where the information is 

found. 

 Provide the delegation of authority from the highest level of 

management given to the MRSC, delineating its authority to oversee 

the licensed program and its responsibility for control and direction 

of the RCP and the RCPD. 

Note: The delegation of authority should state the MRSC’s authority to 

suspend or terminate activities based on poor performance or violation 

of safety standards. 

 Provide the MRSC’s composition and responsibilities. 

 Describe the criteria under which the MRSC will obtain assistance 

from other subject matter experts. 

 List any current subject matter experts or consultants used to 

support the MRSC. 

 

[ ] 

[ ] 

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[ ] 
 B–11 

Item No. Suggested Response Yes Description 

Attached

Radiation Control Program Director Responsibilities (5.10.9) 

 Provide a copy of the written delegation of authority from the highest 

level of management to the RCPD. 

 Provide a description of the RCPD’s responsibilities. 

 Provide documentation to show that the RCPD has access to the 

highest levels of MML management. 

 Describe the measure of administrative and financial control over 

permitting and inspection personnel. 

Permitting and Inspection Staff (5.10.10) 

 Describe the duties of the permitting and inspection staff. 

 Describe how the staff will manage the day-to-day operations of the 

RCP, and include the following: 

− responding to events at permittee facilities 

− maintaining uniformity of program implementation 

− maintaining internal communications 

− ensuring consistency of guidance provided to permittees 

− providing training to RCP staff 

− monitoring and evaluating RCP staff performance 

Radiation Control Program Internal Procedures (5.10.11) 

 Confirm that written internal procedures have been developed that, 

at a minimum, address the functions addressed in Section 5.10.11, 

“Radiation Control Program Internal Procedures.” 

Note: The applicant should confirm that it has written internal 

procedures that at a minimum address the functions addressed in 

Section 5.10.11, but it does not need to submit them with the 

application.

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[ ] 
 B–12 

Item No. Suggested Response Yes Description 

Attached

Management and Master Radiation Safety Committee Audits 

(5.10.12) 

 Describe MRSC oversight and the mechanisms used to ensure 

awareness of NRC regulations, the provisions of the license, and 

the compliance status of the applicant’s RCP. 

 Provide a copy of the audit program used by the MRSC on behalf of 

senior management to audit the performance of the RCP, the 

RCPD, and the inspection and permitting staff, and update senior 

management as needed. 

 Describe how inspectors demonstrate competence in evaluating 

health and safety problems and in determining compliance with 

NRC regulations. 

 Describe how inspectors demonstrate an understanding of 

regulations, inspection guides, and policy practices before 

conducting inspections independently. 

 Describe how permit reviewers demonstrate competence in 

reviewing applications for permits. 

 Describe how reviewers demonstrate an understanding of 

regulations, licensing policy and guidance directives, and permitting 

practices before reviewing and issuing permits independently. 

Note: The process described in the first bullet and the copy of the audit 

programs are descriptive information and are not incorporated in the 

license. The applicant should notify the NRC of significant changes to 

these programs. 

 

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 B–13 

Item No. Suggested Response Yes Description 

Attached

Permitting Procedures (5.10.13) 

 Commit to developing and implementing permitting procedures, 

policies, and guidance: 

− List NRC licensing procedures, policies, and guidance that will 

be used. 

− Provide for NRC review any documents that differ from NRC 

licensing procedures, policies, and guidance. 

 Provide standard permit condition(s) that are not consistent with 

NRC standard license conditions. 

 Submit custom conditions that are less restrictive than applicable 

NRC requirements for further review and approval. 

 Provide specific timeliness goals for issuing permits and updating 

licensing guidance as updates are received from the NRC. 

 Describe document management procedures. 

Program To Minimize Contamination at Permittee Facilities 

(5.10.14) 

 Describe how facility design and procedures for operation will 

(i) minimize, to the extent practicable, contamination of the 

permittees’ facilities and the environment; (ii) facilitate eventual 

decommissioning; and (iii) minimize, to the extent practicable, the 

generation of radioactive waste.

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[ ] 
 B–14 

Item No. Suggested Response Yes Description 

Attached

Decommissioning of Permit Activities and Permit Termination 

(5.10.15) 

 Provide decommissioning and permit termination procedures, or 

commit that permit facilities will be decommissioned and permits will 

be terminated as described in NRC regulations, policies, the 

guidance in NUREG–1757, and the LOU. 

 Confirm that DPs for complex decommissioning sites described in 

Section 5.10.15 will be submitted to the NRC for review and 

approval before commencing decommissioning activities. 

Financial Assurance (5.10.16) 

 Describe how the decommissioning financial assurance 

requirements described in 10 CFR 30.35, 10 CFR 40.36, and 

10 CFR 70.25 will be met. 

 Provide documentation that adequate funds to decommission all 

permitted facilities are established and maintained. 

Inspection and Enforcement Procedures (5.10.17) 

 Provide permit inspection procedures addressing the elements 

discussed in Section 5.10.17, “Inspection and Enforcement 

Procedures.” 

 Provide enforcement program procedures for assessing the severity 

of violations and taking enforcement actions for the more severe 

violations. 

 Provide procedures for documenting inspection findings and 

enforcement actions.

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 B–15 

Item No. Suggested Response Yes Description 

Attached

Incident/Emergency Response Procedures (5.10.19) 

 Provide incident/emergency response procedures that address, at a 

minimum, the following: 

− RCP management oversight responsibilities 

− initial response actions and responsibilities, including safety for 

RCP management and staff, and permittees 

− list of persons responsible for initiating response actions, 

conducting operations, and performing cleanup 

− precautions for persons and property at permittee facilities 

− permittee facility and site access control and security 

− mechanisms and responsibilities for notifying RCP staff and 

external authorities 

− provisions for medical and offsite agency assistance 

− description of emergency response equipment available for use 

by the RCP office staff 

− need for onsite review of events 

− communications between the permittee facility and the RCP 

− communications between the RCP office and the NRC 

 Provide appropriate emergency plan(s) in accordance with 

10 CFR 30.32, if applicable. 

Security Program for Category 1 and Category 2 Materials (5.10.20) 

 Licensees must ensure the security and control of licensed material. 

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. 

[ ] 

[ ] 

Need Not 

Be 

Submitted 

With 

Application 
 B–16 

Item No. Suggested Response Yes Description 

Attached

Procedures for Handling Allegations (5.10.21) 

 Confirm that the NRC’s procedures for handling allegations will be 

used, or provide equivalent procedures for handling allegations that 

are referred to or received by the licensee. 

 Provide procedures for handling, documenting, investigating, and 

closing an allegation raised by a concerned individual. 

 Provide a description of the training that will be provided to all 

employees to ensure that they understand their right to contact the 

NRC directly about radiation safety or regulatory issues. 

[ ] 

[ ] 

[ ] 

11 WASTE MANAGEMENT (5.11) 

 Describe the criteria for approving disposal of radioactive 

waste under 10 CFR Part 20, Subpart K, with the exception of 

10 CFR 20.2002.

 Describe the locations, conditions, and current status of former 

burial sites, whether controlled or uncontrolled; any active 

monitoring of the site; and the current condition of the burial site, for 

permittees who were NRC licensees authorized before 

January 28, 1981, to bury radioactive material. A list of these legacy 

sites (i.e., burial sites) should be available for review to the NRC for 

tracking purposes upon the NRC’s request.

 

[ ] 

[ ] 

Note: Under 10 CFR Part 37, security plans are not to be submitted to the NRC for review 

and approval.
APPENDIX C 

SAMPLE LETTER OF UNDERSTANDING BETWEEN THE 

MASTER MATERIALS LICENSEE AND THE U.S. NUCLEAR 

REGULATORY COMMISSION 

 C–1 

Sample Letter of Understanding between the Master Materials Licensee and 

the U.S. Nuclear Regulatory Commission 

LETTER OF UNDERSTANDING BETWEEN THE (INSERT NAME OF MASTER MATERIALS 

LICENSEE) AND THE U.S. NUCLEAR REGULATORY COMMISSION 

This document defines the shared responsibilities of the U.S. Nuclear Regulatory Commission 

(NRC) and the [insert name of Master Materials Licensee (MML)], regarding the (insert name of 

centralized organization) implementation of and compliance with the terms and conditions of the 

(insert name of MML), NRC License Number (insert license number), as amended. 

ADMINISTRATIVE 

(1) The (insert name of centralized organization) will implement and comply with all NRC 

regulations. When the NRC has promulgated a rule revising its regulations, the (insert 

name of centralized organization) and (insert name of MML) permittees will implement 

and comply with the revised regulations by the effective date of the final rule. The (insert 

name of centralized organization) will incorporate changes to its policies and procedures 

within 90 days after the effective date of the final rule to reflect the revisions to the 

regulations. The (insert name of centralized organization) may elect to be more 

stringent in its controls. 

(2) The MML does not relieve the (insert name of centralized organization) from complying 

with any other applicable Federal or State law or regulation. 

(3) The (insert name of centralized organization) shall seek legal and technical advice from 

the NRC regarding any questions concerning the interpretation of NRC regulations, 

policy, procedures, and guidance, including, but not limited to, advice concerning new or 

unusual applications of licensed materials not clearly authorized by the MML. The NRC 

shall provide the requested legal and technical advice to the (insert name of centralized 

organization) as soon as practicable. 

(4) The (insert name of centralized organization) shall not grant exemptions to NRC 

regulations without specific NRC authorization. 

(5) The (insert name of centralized organization) shall ensure that the transportation of 

licensed material is in accordance with NRC and the U.S. Department of Transportation 

(DOT) regulations regarding the shipment of radioactive materials. The (insert name of 

centralized organization) MML is exempt from Title 10 of the Code of Federal 

Regulations (10 CFR) Part 71, “Packaging and Transportation of Radioactive Material,” 

requirements when using the DOT exemptions issued to the U.S. Department of 

Defense for purposes of national security or national defense. 

(6) "The (insert name of centralized organization) shall ensure that (insert MML) permittees 

will make any required notifications or reports directly to the (insert name of 

centralized organization)." 

(7) The NRC shall provide guidance in areas pertinent to the administration of the MML, 

including technical assistance in those matters where the NRC has special capabilities 
 C–2 

and ability, or where the NRC determines that such assistance is in the best interest of 

its regulatory program or responsibility. 

(8) The NRC shall provide new and revised licensing, inspection, security and enforcement 

guidelines, policies, and procedures to the (insert name of centralized organization) as 

soon as practicable so that the (insert name of centralized organization) can implement 

the MML consistent with the NRC program. The NRC shall provide training to (insert 

name of centralized organization) staff, as available, in all NRC training programs 

concerned with licensing, inspection, health physics, materials security, and other 

regulatory issues related to byproduct, source, and special nuclear material. 

(9) The (insert name of centralized organization) shall maintain an adequate level of 

professional and clerical staffing to carry out its responsibilities under the MML. 

(10) When practical, the (insert name of centralized organization) and the NRC shall use 

electronic means to conduct official business. 

ENVIRONMENTAL 

(11) For those actions that require NRC approval under the MML, the (insert name of 

centralized organization) shall provide any relevant environmental information or 

analysis to support the NRC review. As provided in NRC regulations, certain license 

amendment requests are required to be accompanied by an applicant-prepared 

environmental report (ER) that will aid the NRC staff performing its responsibilities under 

the National Environmental Protection Act of 1969, as amended (NEPA) as implemented 

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

Related Regulatory Functions.” The (insert name of centralized organization) shall 

submit an ER if the criteria of 10 CFR 51.60, “Environmental report—materials licenses,” 

applies. The NRC regulations in 10 CFR 51.45, “Environmental report,” set forth the 

requirements for preparing an ER. Guidance on preparing an ER is set forth in the 

NRC’s NUREG–1748, “Environmental Review Guidance for Licensing Actions 

Associated with NMSS Programs,” Chapter 6. The NRC may also require that 

environmental information be submitted in accordance with 10 CFR 51.41. In 

responding to NRC requests under 10 CFR 50.41, or the requirements of 10 CFR 51.45, 

the applicant may use documents prepared or information obtained through its 

environmental impact analysis work conducted pursuant to the Comprehensive 

Environmental Response, Compensation, and Liability Act (CERCLA), to the extent that 

such documentation or information is timely, pertinent, and responsive to the NRC’s 

request or requirements. 

PERMITTING 

(12) The (insert name of centralized organization) shall incorporate into its permitting 

program the most current version of the NRC’s guidance (NUREG–1556 series, 

“Consolidated Guidance about Materials Licenses”) and the guidance provided in the 

applicable Licensing Guidance Toolkits, which are located on the NRC Web site 

(http://www.nrc.gov), in order to ensure compatibility with the NRC’s licensing program. 

The (insert name of centralized organization) shall not issue a permit to any entity that is 

not a component or constituent part of the (insert name of licensed entity). 
 C–3 

(13) The (insert name of centralized organization) may approve the use of licensed materials 

in a permit by individuals who are not (insert name of licensed entity) personnel if the 

(insert name of centralized organization) determines that such individuals are qualified to 

use such licensed materials under the permit in accordance with applicable NRC 

requirements, applicable procedures established by the (insert name of centralized 

organization), the (insert name of centralized organization) issued permit, and any (insert 

name of licensed entity) facility procedures. The work space of individuals covered by 

this paragraph must be under the control of the (insert name of licensed entity) [i.e., the 

work space must be owned by or leased to the U.S., under the administrative control of 

the (insert name of licensed entity)]. The individuals covered by this paragraph include, 

but are not limited to, (insert name of licensed entity) contractors, students in training, 

and visiting professionals. 

The (insert name of centralized organization) must receive NRC authorization before 

performing any proposed disposal procedures, radioactive waste incineration, 

establishing any new radioactive waste burial site, low-level radioactive contamination 

training area, or outdoor depleted uranium munitions testing range, or conducting any 

field study that may involve the deliberate release of licensed material directly into the 

environment. The (insert name of centralized organization) must submit a written 

description of the proposed activity to the NRC region (region number) office 

for approval. 

INSPECTION 

(14) The (insert name of centralized organization) shall incorporate the current NRC Manual 

Chapter 2800, “Materials Inspection Program,” and applicable NRC inspection 

procedures in its inspection program to ensure compatibility with the NRC’s inspection 

program. The (insert name of centralized organization) may telephonically inspect 

permits with sole commodities (e.g., chemical agent detectors and chemical agent 

monitors) under program code 03124, according to NRC Manual Chapter 2800. 

(15) The (insert name of centralized organization) shall request authorization through the 

NRC region (region number) office to decrease the inspection frequency to meet the 

MML’s priorities. 

(16) The NRC retains the authority to conduct unannounced inspections of the (insert name 

of licensed entity), including permittee programs under the MML, at times and places 

that it has determined are appropriate, without prior notification to the (insert name of 

centralized organization). However, the NRC will routinely provide, through the 

responsible regional office, a 30-day notice to the (insert name of centralized 

organization) of scheduled NRC inspections for the purpose of coordinating security 

access to (insert name of licensed entity) installations, scheduling (insert name of 

licensed entity) inspectors to accompany NRC inspectors, or for other reasons. The 

(insert name of centralized organization) will inform the NRC region (region number) 

office as to whether additional security requirements are required at the respective 

(insert name of licensed entity) installation. If there are additional security requirements, 

then the NRC will process the necessary security clearance in accordance with the 

installation’s procedures. The (insert name of centralized organization) will not notify 

permittees about any proposed unannounced NRC inspection. 
 C–4 

(17) The NRC will perform a biennial inspection of the (insert name of licensed entity) MML 

program as specified in Manual Chapter 2810, “Master Materials License Inspection 

Program.” This inspection will be coordinated between the NRC region (region number) 

office and the (insert name of centralized organization) and will be considered an 

announced inspection. 

ALLEGATIONS 

(18) The (insert name of centralized organization) will inform the NRC region (region number) 

office within 5 calendar days of each allegation received. 

(19) Allegations received by NRC staff regarding MML activities may either be processed by 

the NRC or referred to the (insert name of centralized organization). Allegations of 

suspected wrongdoing will be processed by the NRC region (region number) office for 

entrance into the NRC allegation program. Allegations related to improper action by 

(insert name of centralized organization) staff should not be processed under the (insert 

name of centralized organization) program, but should be referred to the NRC region 

(region number) office for processing. 

(20) The (insert name of centralized organization) may consider establishing a 

safety-conscious work environment in which employees and contractors are free 

to raise potential or actual issues within NRC jurisdiction that may involve operations, 

radiological releases, radiation protection, or other matters relating to NRC-regulated 

activities to their management and to the NRC without fear of retaliation. 

ENFORCEMENT 

(21) The NRC will coordinate with the (insert name of licensed entity) installation regarding 

any enforcement action involving generally licensed devices or other regulatory matters 

that do not involve specifically licensed material under the MML. 

(22) The (insert name of centralized organization) shall implement an enforcement program 

based on the current NRC Enforcement Policy (Policy) to ensure that (insert name of 

centralized organization) enforcement actions are consistent with the Policy and 

applicable NRC regulations, and are uniformly applied amongst (insert name of 

centralized organization) permittees. 

(23) The (insert name of centralized organization) shall immediately notify by telephone the 

NRC region (region number) project manager when the (insert name of centralized 

organization) identifies permittee violations of NRC regulations or MML or (insert name 

of centralized organization) permit requirements that could result in escalated 

enforcement (i.e., Severity Levels I, II, and III). This will be followed with a written report 

to be submitted to the NRC within 30 calendar days of the telephonic notification. The 

facts related to the case shall subsequently be provided to the NRC region (region 

number) office as specified in the NRC Enforcement Manual. 

(24) The (insert name of centralized organization) may take enforcement action against any 

(insert name of centralized organization) permittee for violations of NRC regulations, 

MML conditions, or (insert name of centralized organization) permit conditions. 

However, the (insert name of centralized organization) may not issue a civil penalty to its 

permittee. The NRC region (region number) office will disposition (insert name of 
 C–5 

centralized organization) identified apparent escalated violations and NRC-identified 

violations through the normal NRC enforcement process. The NRC reserves the right to 

impose civil penalties on the MML in accordance with the Enforcement Policy. 

INVESTIGATIONS 

(25) The (insert name of centralized organization) shall report all suspected wrongdoing or 

violations of NRC requirements, as soon as suspected wrongdoing or violations become 

known to (insert name of centralized organization), to the NRC region (region number) 

office by telephone. The (insert name of centralized organization) shall address 

immediate and ongoing safety/security issues promptly and subsequently discuss the 

safety/security issues with the NRC region (region number) office by telephone, followed 

by a written report to the NRC region (region number) office within 30 days of the 

telephonic notice. “Wrongdoing” is defined in 10 CFR 30.10, “Deliberate misconduct.” 

(26) The (insert name of centralized organization) shall notify the NRC of any suspected 

deliberate violations, as soon as suspected deliberate violations become known to 

(insert name of centralized organization), by telephone. The (insert name of centralized 

organization) shall not initiate any criminal investigation into suspected deliberate 

violations without first receiving approval from the NRC’s Office of Investigations (OI). 

The NRC’s OI may evaluate whether to conduct its investigation in coordination with 

the (insert name of licensed entity) investigative agency. In accordance with the 

Memorandum of Understanding between the NRC and the Department of Justice 

(DOJ), the NRC shall refer substantiated wrongdoing violations to DOJ for 

prosecutorial consideration. 

DECOMMISSIONING 

(27) The (insert name of centralized organization) permit termination and decommissioning 

procedures will comply with applicable NRC regulations, procedures and guidance. 

a. The (insert name of centralized organization) will complete permit termination and 

decommissioning for permittees categorized as Groups 1 and 2 facilities in 

accordance with the screening criteria in NUREG–1757, Volume 1, Revision 2, 

“Consolidated Decommissioning Guidance,” and any subsequent revisions. 

b. The (insert name of centralized organization) will submit all actions involving 

decommissioning for permittees categorized as Group 3 and above to the NRC 

region (region number) office for approval. In addition, the (insert name of 

centralized organization) will submit the final status survey report (FSSR) to the 

NRC region (region number) office for approval. The NRC will approve the 

decommissioning plan (DP) and FSSR by letter to the (insert name of centralized 

organization). The NRC shall be responsible for complying with 10 CFR Part 51 for 

Group 3 and above decommissioning actions.

c. The (insert name of centralized organization) will authorize the NRC-approved DP 

and FSSR by permit condition.

d. To ensure compliance with 10 CFR 30.36, “Expiration and termination of licenses 

and decommissioning of sites and separate buildings or outdoor areas,” the (insert 

name of centralized organization) shall ensure that its permittees
 C–6 

− Notify the (insert name of centralized organization) of changes in operating status 

in accordance with 10 CFR 30.36(d). 

− Submit a DP to the (insert name of centralized organization) in accordance 

with 10 CFR 30.36(g)(1) for final approval by the NRC before beginning 

decommissioning. 

 

− Submit any requests to extend time periods established in 10 CFR 30.36(d), 

in accordance with 10 CFR 30.36(f), to the (insert name of centralized 

organization). 

− Submit any requests for an alternative schedule for completion of 

decommissioning in accordance with 10 CFR 30.36(i) to the (insert name of 

centralized organization). 

− Submit permit termination requests upon completion of decommissioning, in 

accordance with 10 CFR 30.36(j), to the (insert name of centralized organization) 

− Preserve records showing the receipt, transfer, and disposal of byproduct 

material in accordance with 10 CFR 30.51. 

− Forward, upon completion of permit termination and decommissioning, the 

records of receipt, transfer, and disposal of byproduct material to the (insert 

name of centralized organization) for storage until the MML is terminated. 

e. To ensure compliance with 10 CFR 30.36, the (insert name of centralized 

organization) shall 

− Notify the NRC region (region number) office of all changes in operating status of 

permittees pursuant to the notification requirements in 10 CFR 30.36(d). 

− Transmit all DPs to the NRC region (region number) office for approval. 

− Transmit requests to extend time periods established in 10 CFR 30.36(d), in 

accordance with 10 CFR 30.36(f), to the NRC region (region number) office for 

approval. 

− Transmit requests for alternative schedules for completion of decommissioning to 

the NRC region (region number) office for approval. 

− Transmit requests for permit termination in accordance with 10 CFR 30.36(j) 

upon completion of decommissioning activities to the NRC region (region 

number) office for approval, with the exception of Broad Scope permittees who 

retain the facility or land until such time as they release the facility or land from 

their ownership, as described in NUREG–1757, Volume 1, Revision 2, 

“Consolidated Decommissioning Guidance.” 

− Retain permittee records showing the receipt, transfer, and disposal of byproduct 

material, as well as records regarding permittee decommissioning activities, until 

the MML is terminated. 
 C–7 

PROCEDURES 

(28) The (insert names of licensed entity and centralized organization) will reference its 

programmatic procedures for the implementation of the MML program [insert the 

procedure acronym(s), title, and number(s)]. 

(29) The (insert name of centralized organization) is authorized to make program changes 

and changes to procedures specifically identified previously, which were previously 

approved by the NRC and incorporated into the MML, without prior NRC approval, as 

long as 

a. The proposed revision is documented, reviewed, and approved by the (insert name 

of the centralized organization) in accordance with established procedures before 

implementation. 

b. The revised program is in accordance with applicable NRC regulatory requirements 

and will not change any license conditions of the MML, and the (insert name of 

centralized organization) has determined that the change will not decrease 

the effectiveness of the (insert name of centralized organization) radiation 

safety program. 

c. The staff of the (insert name of centralized organization) and the permittee are 

trained in the revised procedures before implementation. 

d. The audit program of the (insert name of centralized organization) and the permittee 

evaluates the effectiveness of the change and its implementation. 

(30) The (insert name of centralized organization) routine implementing procedures are 

identified as standard operating procedures (SOP) for the MML program and are not 

incorporated into the MML. Therefore, they may be revised without NRC approval. 

(31) The NRC and the MML will review this Letter of Understanding periodically. If changes 

are warranted, then the MML and the NRC will seek to finalize such changes within 

180 days of the review.

SIGNATORIES 

The Signatories represent that they have the authority from their respective agencies to 

enter into this agreement on their agencies’ behalf and that each agency agrees to uphold 

their responsibilities as identified above. The responsibilities identified above become 

effective on the last date shown at the bottom of this letter and shall remain in effect from 

that date forward unless modified by written agreement of the parties. 

______________________________ _____________________________ 

(insert name of NRC Certifying Official, title) (MML Certifying Official) 

(insert name of Branch) 

(insert name of Division) 

Region (region number) 

Dated: Dated: 

APPENDIX D 

SAFETY CULTURE POLICY STATEMENT 

 D–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 U.S. Nuclear Regulatory Commission’s (NRC) Agencywide 

Documents Access and Management System under Accession No. ML11146A047. 

Safety Culture Policy Statement 

The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

individuals and organizations establish and maintain a positive safety culture commensurate 

with the safety and security significance of their activities and the nature and complexity of their 

organizations and functions. This includes all licensees, certificate holders, permit holders, 

authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

safety-related components, and applicants for a license, certificate, permit, authorization, or 

quality assurance program approval, subject to NRC authority. The Commission encourages 

the Agreement States, Agreement State licensees and other organizations interested in nuclear 

safety to support the development and maintenance of a positive safety culture, as articulated in 

this Statement of Policy. 

Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

commitment by leaders and individuals to emphasize safety over competing goals to ensure 

protection of people and the environment. Individuals and organizations performing regulated 

activities bear the primary responsibility for safety and security. The performance of individuals 

and organizations can be monitored and trended and, therefore, may be used to determine 

compliance with requirements and commitments and may serve as an indicator of possible 

problem areas in an organization’s safety culture. The NRC will not monitor or trend values. 

These will be the organization’s responsibility as part of its safety culture program. 

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

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

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

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

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

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

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

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

with NRC-regulated activities. 

Experience has shown that certain personal and organizational traits are present in a positive 

safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that 

emphasizes safety, particularly in goal conflict situations, e.g., production, schedule, and the 

cost of the effort versus safety. It should be noted that although the term ‘‘security’’ is not 

expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

regulatory mission. Consequently, consideration of both safety and security issues, 

commensurate with their significance, is an underlying principle of this Statement of Policy. 

 
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The following are traits of a positive safety culture: 

(1) Leadership Safety Values and Actions—Leaders demonstrate a commitment to safety in 

their decisions and behaviors. 

(2) Problem Identification and Resolution—Issues potentially impacting safety are promptly 

identified, fully evaluated, and promptly addressed and corrected commensurate with 

their significance. 

(3) Personal Accountability—All individuals take personal responsibility for safety. 

(4) Work Processes—The process of planning and controlling work activities is implemented so 

that safety is maintained. 

(5) Continuous Learning—Opportunities to learn about ways to ensure safety are sought out 

and implemented. 

(6) Environment for Raising Concerns—A safety conscious work environment is maintained 

where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

harassment, or discrimination. 

(7) Effective Safety Communication—Communications maintain a focus on safety. 

(8) Respectful Work Environment—Trust and respect permeate the organization. 

(9) Questioning Attitude—Individuals avoid complacency and continuously challenge existing 

conditions and activities in order to identify discrepancies that might result in error or 

inappropriate action. 

There may be traits not included in this Statement of Policy that are also important in a positive 

safety culture. It should be noted that these traits were not developed to be used for 

inspection purposes. 

It is the Commission’s expectation that all individuals and organizations, performing or 

overseeing regulated activities involving nuclear materials, should take the necessary steps to 

promote a positive safety culture by fostering these traits as they apply to their organizational 

environments. The Commission recognizes the diversity of these organizations and 

acknowledges that some organizations have already spent significant time and resources in the 

development of a positive safety culture. The Commission will take this into consideration as 

the regulated community addresses the Statement of Policy. 
APPENDIX E 

COMMENCEMENT OF CONSTRUCTION AT EXISTING AND 

PROPOSED BYPRODUCT (INCLUDING IRRADIATORS), 

SOURCE, AND SPECIAL NUCLEAR MATERIAL FACILITIES WITH 

SIGNIFICANT ENVIRONMENTAL IMPACTS 

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COMMENCEMENT OF CONSTRUCTION AT EXISTING AND 

PROPOSED BYPRODUCT (INCLUDING IRRADIATORS), 

SOURCE, AND SPECIAL NUCLEAR MATERIAL FACILITIES WITH 

SIGNIFICANT ENVIRONMENTAL IMPACTS 

PURPOSE AND SCOPE 

This appendix provides information concerning the definition of “construction,” and activities that 

may be performed by materials license applicants, potential applicants (hereinafter collectively 

referred to as “applicants”), and licensees before the U.S. Nuclear Regulatory Commission 

(NRC) staff has concluded its environmental review of the proposed licensing action. 

This appendix applies to all Title 10 of the Code of Federal Regulations (10 CFR) Parts 30 

(byproduct material), 36 (irradiators), 40 (source material) and 70 (special nuclear material 

[SNM]) facilities except for uranium recovery facilities, uranium hexafluoride conversion 

facilities, enrichment facilities, fuel fabrication facilities, uranium hexafluoride deconversion 

facilities, and facilities for SNM of greater than critical mass. 

Except as noted in the previous paragraph, this appendix applies to licensing actions related to 

the receipt and possession of licensable byproduct, source, and SNM for the conduct of any 

activity which the NRC determines will significantly affect the quality of the environment. Except 

as noted in the previous paragraph, the information in this appendix should be reviewed by all 

holders of operating licenses for byproduct (including irradiators), source, and SNM facilities, 

and all persons who have submitted applications to construct byproduct, source, and SNM 

facilities, or have submitted letters of intent to submit such applications under 10 CFR Parts 30, 

36, 40, and 70. 

If a licensing action initiated pursuant to 10 CFR Parts 30, 40, or 70 meets any of the criteria in 

10 CFR 51.20 or 51.21, then commencement of construction of a facility before the NRC staff 

has completed its environmental review process is grounds for denial of the license application, 

in accordance with 10 CFR 30.33(a)(5), 40.32(e), and 70.23(a)(7). However, if the licensing 

action meets the criteria in 10 CFR 51.22(c) for a categorical exclusion, and the NRC has not 

determined that an environmental assessment or an environmental impact statement is required 

in accordance with 10 CFR 51.22(b), then commencement of construction before the NRC staff 

concludes the environmental process should not be the sole basis for denial of the license 

application, as the NRC has already determined that this category of actions does not have a 

significant impact on the environment. 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 (including irradiators), source, and SNM 

licenses in the final rule, “Licenses, Certifications, and Approvals for Materials Licensees” 

(76 FR 56951; September 15, 2011) (Material Licenses Construction Rule). The revisions 

contained in the Material Licenses Construction Rule revised the definitions of “construction” 

and “commencement of construction” for materials licensing actions. 
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The definitions of “commencement of construction” in 10 CFR 30.4, 36.2, 40.4, and 70.4 

are identical. 

Commencement of construction means taking any action defined as “construction” or any other 

activity at the site of a facility subject to the regulations in this part that has a reasonable 

nexus to: 

1. radiological health and safety; or 

2. common defense and security. 

The definitions of “construction” in 10 CFR 30.4, 36.2, and 70.4 are identical. 

Construction is defined as the installation of foundations, or in-place assembly, erection, 

fabrication, or testing for any structure, system, or component of a facility or activity subject to 

the regulations in this part that are related to radiological safety or security. The term 

“construction” does not include: 

(1) changes for temporary use of the land for public recreational purposes; 

(2) site exploration, including necessary borings to determine foundation conditions or other 

preconstruction monitoring to establish background information related to the suitability 

of the site, the environmental impacts of construction or operation, or the protection of 

environmental values; 

(3) preparation of the site for construction of the facility, including clearing of the site, 

grading, installation of drainage, erosion and other environmental mitigation measures, 

and construction of temporary roads and borrow areas; 

(4) erection of fences and other access control measures that are not related to the safe use 

of, or security of, radiological materials subject to this part; 

(5) excavation; 

(6) erection of support buildings (e.g., construction equipment storage sheds, warehouse 

and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and 

office buildings) for use in connection with the construction of the facility; 

(7) building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility 

and lighting systems, potable water systems, sanitary sewerage treatment facilities, and 

transmission lines); 

(8) procurement or fabrication of components or portions of the proposed facility occurring 

at other than the final, in-place location at the facility; or 

(9) taking any other action that has no reasonable nexus to: 

(i) radiological health and safety, or 

(ii) common defense and security. 
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“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 appendix should be used to evaluate whether a particular construction activity has a nexus 

to radiological health and safety, and thus falls under the jurisdiction of the NRC for licensing 

purposes. An activity or action has a reasonable nexus to radiological health and safety or the 

common defense and security if that activity or action has a rational, direct link to ensuring that 

a materials facility is operating, or will operate, in accordance with the NRC’s regulations and in 

a manner that protects the public health and safety or the common defense and security from 

radiological hazards. The definitions of construction in 10 CFR 30.4, 36.2, 40.4, and 70.4 

150.31 list activities that are not considered “construction.” This appendix provides examples of 

activities that fall under each of the excepted activities that do not constitute construction. Site 

preparation activities that are not considered “construction,” while not under NRC jurisdiction, 

may be subject to the regulatory authority of another Federal, State, or local agency which may 

require National Environmental Policy Act or state environmental review. NRC’s responsibilities 

under the National Historic Preservation Act of 1966, as amended (NHPA), must also be 

satisfied before a license is issued. Specifically, as noted in the statements by the NRC 

published with the final Material Licenses Construction Rule, under certain circumstances the 

NRC may be required to deny a license application if the NRC determines that the applicant 

intentionally significantly adversely affected, or allowed to be affected, a historic property with 

intent to avoid the requirements of §106 of the NHPA. 

DISCUSSION OF EXAMPLES 

In addition to the background discussion provided above, the following examples clarify the 

delineation of site preparation activities and construction activities. It is important to recognize 

that the NRC may have regulatory authority over activities that can occur before construction 

begins, such as procurement of basic components as defined in 10 CFR Part 21, the process of 

dedicating commercial grade items or basic components, or procurement of items relied on for 

safety (IROFS) as defined in 10 CFR Part 70. It should also be noted that, while site 

preparation activities may not require prior NRC approval, the approval of local, State, or other 

Federal agencies may be required. 

BYPRODUCT MATERIAL (10 CFR PART 30) 

Prior to the conclusion of the environmental review process, applicants for byproduct material 

licenses or license amendments should not perform construction activities that have a nexus to 

radiological health and safety or the common defense and security. An activity or action has a 

reasonable nexus to radiological health and safety or the common defense and security if that 

activity or action has a rational, direct link to ensuring that a licensed materials facility is 

operating, or will operate, in accordance with the NRC’s regulations and in a manner that 

protects the public health and safety or the common defense and security from 

radiological hazards. 
E–4 

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 non-structural); and the placement of 

concrete or other material constituting the foundation of any safety-related feature. 

The term “permanent” in this context includes anything that will exist in its final, in-place facility 

location after commencement of operations with licensed material. Construction also includes 

the “onsite, in-place” fabrication, erection, integration, or testing activities for any in-scope 

safety-related equipment. The terms “onsite, in place, fabrication, erection, integration, or 

testing” describe the process of constructing a facility in its final, onsite plant location, where 

components or modules are integrated into the final, in-plant location. The fabrication, 

assembly, and testing of components and modules in a shop building, warehouse, or laydown 

area, even if located onsite, is not construction. However, the installation or integration of the 

safety-related equipment into its final plant location is construction. 

Construction also includes driving piles for safety-related equipment. Hence, an applicant must 

obtain a license before driving piles for safety-related equipment. However, driving piles that do 

not ensure the structural stability or integrity of a safety-related structure (e.g., piles driven to 

support the erection of a bridge for a temporary or permanent access road) is not construction; 

therefore, those piles may be driven prior to the NRC staff concluding its environmental review 

of a proposed action. 

IRRADIATORS (10 CFR PART 36) 

An applicant for a new irradiator license under 10 CFR Part 36 may perform the nonconstruction activities identified in revised 10 CFR 36.2 at any time. However, installation of 

foundations or in-place assembly, erection, fabrication, or testing for any structure, system, or 

component of a facility or activity subject to 10 CFR Part 36 that has a reasonable nexus to 
E–5 

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 lists the systems that have a nexus to radiological health and 

safety and defines the related engineering and safety concerns associated with each system: 

 access control: adequacy of access control systems using interlocks and radiation 

monitors to prevent inadvertent entry to areas where radiation sources are unshielded; 

to provide emergency exits; and to ensure compliance with all the requirements of 

10 CFR 36.23; (For computer-controlled access-control systems, licensing staff should 

consider expert evaluation of the software/system logic before operational testing.) 

 site: potential need for protection against flooding and earth slides 

 base (soil, rock) for the pool and shielding structures: strength, settlement, liquefaction, 

ground water, and soil compaction 

 footers and foundations for the pool and shielding structures: strength and 

reinforcement, alignment with pool and shielding structures 

 pool and shielding structures: strength and reinforcement, proper density of shielding 

materials, correct dimensions, minimization of voids in concrete or other shielding 

 pool liner: contact with pool structure, penetrations in the liner, leak-tight welds 

 pool plumbing: makeup water system; water cleanup system; effect of construction 

materials on pool-water chemistry; drainage system (potentially contaminated spilled 

water should flow into the pool); siphon breakers; radiation detection and alarm systems 

 penetrations through shielding: any significant effect on structural strength, shielding, 

or both 
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 source rack protection (if the product to be irradiated moves on a product conveyor 

system): source rack and the mechanism that moves the rack must be protected by a 

barrier or guides to prevent products and product carriers from hitting or touching the 

rack or mechanism 

 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 source-rack; 

adequacy of mechanical or electrical means for personnel to safely release and lower 

the rack; need for, and adequacy of, a system to cool the source-rack until it can be 

released and lowered 

 ozone ventilation system: capability of the system to be properly initiated and to provide 

adequate volume flow rate of air to protect personnel and components 

 system for transferring sources from and to transport vehicles: adequately sized 

openings in the shield-structure roof if sources are roof-loaded; structural adequacy of 

the roof-shield plug and its supports for its removal and replacement; structural and 

mechanical adequacy of systems for moving shipping containers into and out of the 

pool area 

 
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ACTIVITIES WHICH HAVE NO REASONABLE NEXUS TO RADIOLOGICAL SAFETY OR 

SECURITY 

The NRC has determined that, in general, the following activities at byproduct (including 

irradiators), source, and SNM facilities listed in 10 CFR 30.4, 36.2, 40.4, and 70.4, do not have 

a reasonable nexus to radiological health and safety and the common defense and security may 

be performed by a licensee or applicant at any time. Note that in some circumstances, based 

on the specific licensing proposal, any of these activities could be determined to have a 

reasonable nexus to radiological health and safety or common defense and security and, based 

on that determination, these activities would be construction: 

(1) changes for temporary use of the land for public recreational purposes; 

(2) site exploration, including necessary borings to determine foundation conditions or other 

preconstruction monitoring to establish background information related to the suitability 

of the site, the environmental impacts of construction or operation, or the protection of 

environmental values; 

(3) preparation of the site for construction of the facility, including clearing of the site, 

grading, installation of drainage, erosion and other environmental mitigation measures, 

and construction of temporary roads and borrow areas; 

(4) erection of fences and other access control measures that are not related to the safe use 

of, or security of, radiological materials subject to 10 CFR Parts 30, 36, 40, or 70; 

(5) excavation; 

(6) erection of support buildings (e.g., construction equipment storage sheds, warehouse 

and shop facilities, utilities, concrete mixing plants, docking and unloading facilities, and 

office buildings) for use in connection with the construction of the facility; 

(7) building of service facilities (e.g., paved roads, parking lots, railroad spurs, exterior utility 

and lighting systems, potable water systems, sanitary sewerage treatment facilities, and 

transmission lines); 

(8) procurement or fabrication of components or portions of the proposed facility occurring 

at other than the final, in-place location at the facility; or 

(9) taking any other action that has no reasonable nexus to: 

(i) radiological health and safety, or 

(ii) common defense and security. 

While the above site preparation activities may not require prior NRC approval, the approval of 

local, State, or other Federal agencies may be required. 

REFERENCES 

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

Materials Facilities,” August 2003 
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 DC/COL–ISG–4, “Interim Staff Guidance on the Definition of Construction and on 

Limited Work Authorizations,” February 9, 2009, ML082970729 
APPENDIX F 

CHECKLIST FOR REQUESTS TO WITHHOLD PROPRIETARY 

INFORMATION FROM PUBLIC DISCLOSURE (UNDER 10 CFR 2.390)

F–1 

Checklist for Requests to Withhold Proprietary Information from Public 

Disclosure (Under 10 CFR 2.390)

In order to request that the U.S. Nuclear Regulatory Commission (NRC) withhold information 

from public disclosure, the applicant or licensee must submit the information, including an 

affidavit, in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 2.390, 

“Public Inspections, Exemptions, Requests for Withholding.” The applicant should submit all of 

the following: 

 A proprietary copy of the information. Brackets should be placed around the material 

considered to be proprietary. This copy should be marked as proprietary. 

 A non-proprietary copy of the information. Applicants should white out or black out the 

proprietary portions (i.e., those in the brackets), leaving the non-proprietary portions 

intact. This copy should not be marked as proprietary. 

 An affidavit that: 

 Is signed under oath and affirmation (notarization may suffice). 

 Clearly identifies (such as by name or title and date) the document to be 

withheld. 

 Clearly identifies the position of the person executing the affidavit. This person 

must be an officer or upper-level management official who has been delegated the 

function of reviewing the information the organization is seeking to withhold and is 

authorized to apply for withholding on behalf of the organization. 

 States that the organization submitting the information is the owner of the 

information or is required, by agreement with the owner of the information, to treat 

the information as proprietary. 

 Provides a rational basis for holding the information in confidence. 

 Fully addresses the following issues: 

 Is the information submitted to, and received by, the NRC in confidence? 

Provide details. 

 To the best of the applicant’s knowledge, is the information currently available 

in public sources? 

 Does the applicant customarily treat this information, or this type of information, 

as confidential? Explain why. 

 Would public disclosure of the information be likely to cause substantial harm 

to the competitive position of the applicant? If so, explain why in detail. The 

explanation should include the value of the information to your organization, the 

amount of effort or money expended in developing the information, and the 

ease or difficulty for others to acquire the information. 





NUREG-1556, Vol. 10

Revision 1, Final

Consolidated Guidance About Materials Licenses: Program-Specific 

Guidance About Master Materials Licenses