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Program-Specific Guidance About Fixed Gauge Licenses - Final Report (NUREG-1556, Vol. 4)

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Table of Contents

• Publication Information
• Abstract
• Figures
• Foreword
• Acknowledgments
• Abbreviations
• 1 Purpose of Report
• 2 Agreement States
• 3 Management Responsibility
• 4 Applicable Regulations
• 5 How to File
• 5.1 Paper Application
• 5.2 Electronic Application
• 6 Where to File
• 7 License Fees
• 8 Contents of an Application
• 8.1 Item 1: License Action Type
• 8.2 Item 2: Applicant's Name and Mailing Address
• 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or Possessed
• 8.4 Item 4: Person to Be Contacted about this Application
• 8.5 Item 5: Radioactive Material
• 8.5.1 Sealed Sources and Devices
• 8.5.2 Financial Assurance and Recordkeeping for Decommissioning
• 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used
• 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and Their Training Experience
• 8.7.1 Radiation Safety Officer (RSO)
• 8.7.2 Authorized Users
• 8.8 Item 8: Training for Individuals Who in the Course of Employment Are Likely to Receive Occupational Doses of Radiation in Excess of 1 Msv (100 Mrem) in a Year (Occupationally Exposed Workers) and Ancillary Personnel
• 8.9 Item 9: Facilities and Equipment
• 8.10 Item 10: Radiation Safety Program
• 8.10.1 Audit Program
• 8.10.2 Instruments
• 8.10.3 Material Receipt and Accountability
• 8.10.4 Occupational Dose
• 8.10.5 Public Dose
• 8.10.6 Operating and Emergency Procedures
• 8.10.7 Leak Tests
• 8.10.8 Maintenance
• 8.10.9 Transportation
• 8.10.11 Minimization of Contamination
• 8.11 Item 11: Waste Management
• 8.11.1 Gauge Disposal and Transfer
• 8.12 Item 12: Fees
• 8.13 Item 13: Certification
• 9 Amendments and Renewals to a License
• 10 Applications for Exemptions
• 11 Termination of Activities
• Appendix A: NRC Form 313
• Appendix B: Suggested Format for Providing Information Requested in Items 5 Through 11 of NRC Form 313
• Appendix C: Information Needed for Transfer of Control Application
• Appendix D: Reviewer Checklist for Fixed Gauge Application
• Appendix E: Sample SSD Registration Certificate
• Appendix F: Typical Duties and Responsibilities of the Radiation Safety Officer
• Appendix G: Criteria for Acceptable Training for Authorized Users and Radiation Safety Officers
• Appendix H: Suggested Fixed Gauge Audit Checklist
• Appendix I: Model Survey Instrument Calibration Program
• Appendix J: Guidance for Demonstrating That Unmonitored Individuals Are Not Likely to Exceed 10 Percent of the Allowable Limits
• Appendix K: Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits
• Appendix L: Operating and Emergency Procedures
• Appendix M: Model Leak Test Program
• Appendix N: Information Needed to Support Applicant's Request to Perform Non-Routine Operations
• Appendix O: Major DOT Regulations; Sample Shipping Documents, Placards and Labels
• Appendix P: NRC Incident Notifications
• Appendix Q: Sample Fixed Gauge License
• Appendix R: List of Documents Considered in Development of this NUREG
• Appendix S: Addendum: Responses to Comments on Draft NUREG-1556, Vol. 4, Dated October 1997

Publication Information

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Manuscript Completed: October 1998
Date Published: October 1998

Prepared by
P.J. Henderson, A.S. Kirkwood, S.H. Lewis, W.H. Radcliffe, G.M. Watson

Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001

Availablity Notice

Abstract

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As part of its redesign of the materials licensing process, the Nuclear Regulatory Commission (NRC) is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556, Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauges Licenses," dated October 1998, is the fourth program-specific guidance developed for the new process and is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance found in Draft Regulatory Guide and Value/Impact Statement, FC 404-4, "Guide for the Preparation of Applications for Licenses for the Use of Sealed Sources and Nonportable Gauging Devices," dated January 1985, in NMSS Policy and Guidance Directive (P&GD), FC 85-4, "Standard Review Plan for Applications for Use of Sealed Sources and Nonportable Gauging Devices," dated February 6, 1985, and in NMSS P&GD, FC 85-8, Revision (Rev.) 1, "Licensing of Fixed Gauges and Similar Devices," dated June 29, 1988. This final report takes a more risk-informed, performance-based approach to licensing fixed gauges, and reduces the information (amount and level of detail) needed to support an application to use these devices. It incorporates many suggestions received during the comment period on draft NUREG-1556, Vol. 4. When published, this final report should be used in preparing fixed gauge license applications. NRC staff will use this final report in reviewing these applications.

Figures

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1.1 Fixed Gauge Basic Design Features.

1.2 Where is the Radioactive Source?

2.1 U.S. Map. Location of NRC Offices and Agreement States.

8.1 Examples of Several Different Types of Fixed Gauges.

8.2 RSO Responsibilities. Typical duties and responsibilities of RSOs.

8.3 Material Receipt and Accountability. Licensees must maintain records of receipt, transfer, and disposal and conduct semiannual physical inventories.

8.4 Annual Dose Limits for Occupationally Exposed Adults.

8.5 Limiting Public Dose.

8.6 Proper Handling of Incident.

8.7 Lock-out Procedures.

8.8 Leak Test Sample.

8.9 Maintenance.

8.10 Transportation.

8.11 Proper Handling of Incident.

8.12 Examples of Uses for Fixed Gauges at Temporary Job Sites.

8.13 DOT Transportation Requirements.

8.14 Security.

8.15 Installation of Fixed Gauges at Temporary Job Sites.

8.16 Security.

Appendix E 1: Functional Sketch of the Model

Appendix E 2: Model

Appendix E 3: Label on Outer Housing

Appendix E 4: Side Cut View & Top View

Appendix E 5: Bottom Plate View & Side View 90° Rotation

Appendix K 1: Diagram of Bottling Line and Fixed Gauges

Appendix Q 1: 1 of 6 Material Licensee

Appendix Q 2: 2 of 6 Materials License (Supplementary Sheet)

Appendix Q 3: 3 of 6 Materials License (Supplementary Sheet)

Appendix Q 4: 4 of 6 Materials License (Supplementary Sheet)

Appendix Q 5: 5 of 6 Materials License (Supplementary Sheet)

Appendix Q 6: 6 of 6 Materials License (Supplementary Sheet)

Foreword

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The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a listing of volumes currently included in the NUREG-1556 series: "Consolidated Guidance About Materials Licenses":

The current document (NUREG-1556, Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauges," dated October 1998) is the fourth program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It supersedes the guidance for applicants and licensees previously found in Draft Regulatory Guide and Value/Impact Statement, FC 404-4, "Guide for the Preparation of Applications for Licenses for the Use of Sealed Sources in Nonportable Gauging Devices," dated January 1985, and the guidance for licensing staff previously found in P&GD, FC 85-4, "Standard Review Plan for Applications for the Use of Sealed Sources in Nonportable Gauging Devices," dated February 6, 1985, P&GD, FC 85-8, Rev. 1, "Licensing of Fixed Gauges and Similar Devices," dated June 29, 1988, and the documents marked with an asterisk (*) in Appendix Q. NUREG-1556, Vol. 4 incorporates suggestions submitted during the comment period on draft NUREG-1556, Vol. 4. See the Addendum for summaries of comments, staff responses, and other changes.

This report takes a risk-informed, performance-based approach to licensing fixed gauges, i.e., it reduces the amount of information needed from an applicant seeking to possess and use a relatively safe device. These fixed gauges containing sealed sources of radioactive material incorporate features engineered to enhance their safety. NRC's considerable experience with these licensees indicates that radiation exposures to workers are generally low, if workers follow basic safety procedures, and the gauges operate as designed.

A team composed of NRC staff from headquarters and regional offices drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to fixed gauges. A representative of NRC's Office of the General Counsel provided a legal perspective.

NUREG-1556, Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauges," dated October 1998, represents a step in the transition from the current paper-based process to the new electronic process. This document is available on the Internet at the following uniform resource locator (URL): <http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v4/index.html>

The performance-based approach in NUREG-1556, Vol. 4, gives licensees greater flexibility than previously permitted under licenses based on applications prepared according to Draft Regulatory Guide and Value/Impact Statement, FC 404-4, "Guide for the Preparation of Applications for Licenses for the Use of Sealed Sources in Nonportable Gauging Devices," dated January 1985. This guidance document permits licensees to make more changes in their radiation safety program without amending their licenses, thus reducing the regulatory burden on licensees and the NRC staff. Accordingly, existing fixed gauge licensees have the option of submitting a complete application using NUREG-1556, Vol. 4, at the time that they file an amendment request. Licensees choosing this option should incorporate the requested change into the complete application, submit it with the appropriate amendment fee, and indicate that the complete revision is an amendment request to take advantage of the new guidance. When the staff has reviewed the request and resolved any outstanding issues, the staff will amend the license without changing the expiration date.

Licensees wishing to renew their licenses should submit a complete application according to NUREG-1556, Vol. 4. The staff's action will be similar to that described for amendments, but will include an extension of the license's expiration date. By following this procedure, the staff expects all existing fixed gauge licenses to be converted to the more performance-based format within a few years.

This report describes and makes available to the public information on: methods acceptable to the NRC staff for implementing specific parts of the Commission's regulations; techniques the staff uses in evaluating applications, including specific problems or postulated accidents; and data the NRC staff needs to review applications for licenses. NUREG-1556, Vol. 4, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauges," dated October 1998, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this report are provided for information only. Methods and solutions different from those described in this report will be acceptable if they provide a basis for the staff to make the determinations needed to issue or continue a license.

__________________________________
Frederick C. Combs, Acting Director
Division of Industrial and Medical Nuclear Safety
Office of Nuclear Material Safety and Safeguards

Acknowledgments

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The writing team thanks the individuals listed below for assisting in the development and review of both the draft and final reports. All participants provided valuable insights, observations, and recommendations.

The team also thanks Kay Avery, Kathryn M. LaViolette, D. W. Benedict Llewellyn, Alyce J. Martin, Carla T. Purvis, Steven W. Schawaroch, and Gina G. Thompson of Computer Sciences Corporation and Angela S. Case of Total Systems Solutions, Inc.

The Participants

Blough, A. Randolph
Camper, Larry W.
Caniano, Roy J.
Combs, Frederick C.
Cool, Donald A.
Henderson, Pamela J.
Johansen, Jenny M.
Jones, Cynthia G.
Kirkwood, Anthony S.
Lewis, Stephen H.
Merchant, Sally L.
Piccone, Josephine M.
Radcliffe, William R.
Roe, Mary Louise
Schwartz, Maria E.
Treby, Stuart A.
Vacca, Patricia C.
Watson, Gidget M.

Abbreviations

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1 Purpose of Report

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This report provides guidance to an applicant in preparing a fixed gauge license application as well as NRC criteria for evaluating a fixed gauge license application. It is not intended to address the research and development of fixed gauges or the commercial aspects of manufacturing, distribution, and service of such devices. Within this document, the phrases or terms, "fixed gauge," "gauging devices," or "gauges" are used interchangeably.

This report addresses a variety of radiation safety issues associated with fixed gauges of many designs. Figure 1.1 is a cutaway diagram of a typical fixed gauge showing basic design features. Figure 1.2 illustrates various designs of fixed gauges based, in part, on their intended use and the location of the radioactive source within the gauges. Typically gauges are used for process control (e.g., to measure the thickness of paper, the density of coal, the level of material in vessels and tanks, and volumetric flow rate). Because of differences in design, manufacturers provide appropriate instructions and recommendations for proper operation and maintenance. In addition, with gauges of varying designs, the sealed sources may be oriented in different locations within the devices, resulting in different radiation safety problems.

Figure 1.1 Fixed Gauge Basic Design Features. Cutaway of a typical fixed gauge diagraming the basic design features: the source, source holder, detector, shutter, shutter control or on-off mechanism, and shielding.

Figure 1.2 Where is the Radioactive Source? The wide variety of fixed gauge designs results in different radiation safety considerations.

This report identifies the information needed to complete NRC Form 313 (Appendix A), "Application for Material License," for the use of sealed sources in fixed gauges. The information collection requirements in Title 10, Code of Federal Regulations, Part 30 (10 CFR Part 30) and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017 and 3150-0120, respectively.

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

• Regulations -- references the regulations applicable to the item;
• Criteria -- outlines the criteria used to judge the adequacy of the applicant's response;
• Discussion -- provides additional information on the topic sufficient to meet the needs of most readers; and
• Response from Applicant -- provides suggested response(s), offers the option of an alternative reply, or indicates that no response is needed on that topic during the licensing process.

Notes and References are self-explanatory and may not be found for each item on NRC Form 313.

Appendix B provides a convenient format to respond to items 5 through 11 on NRC Form 313 (Appendix A) since the form does not have sufficient space for applicants to provide full responses to these items. For streamlined handling of fixed gauge applications in the new materials licensing process, use Appendix B to provide supporting information, attach it to NRC Form 313, and submit them to NRC. Otherwise, as indicated on NRC Form 313, the answers to items 5 through 11 are to be provided on separate sheets of paper and submitted with the completed NRC Form 313.

Appendix C contains information needed for transfer of control. Appendix D is a checklist that NRC staff uses to review applications and applicants can use to check for completeness. Appendix E contains a sample SSD Registration Certificate. Appendixes F through P contain additional information on various radiation safety topics. Appendix Q is a sample fixed gauge license; it contains the conditions most often found on these licenses, although not all licenses will have all conditions. Appendix R contains a list of all documents used to develop this NUREG (NUREG-1556, Vol. 4). The Addendum contains the comments received on draft NUREG-1556, Vol. 4 and NRC staff's response to each comment.

In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent (EDE), committed dose equivalent (CDE), committed effective dose equivalent (CEDE), or total effective dose equivalent (TEDE). These terms are defined in 10 CFR Part 20. Rem, and its SI equivalent Sievert (1 rem = 0.01 Sievert (Sv)), are used to describe units of radiation exposure or dose. This is done because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen (R). When the sealed sources used in gauges emit beta and gamma rays, for practical reasons, we are assuming that 1 R = 1 rad = 1 rem. Less common are sealed sources used in gauges that emit neutrons or alpha particles. For neutron and alpha emitting sealed sources, 1 rad is not equal to 1 rem. Determination of dose equivalent (rem) from absorbed dose (rad) from neutrons and alpha particles requires the use of an appropriate quality factor (Q) value. Q values are used to convert absorbed dose (rad) to dose equivalent (rem). Q values for neutrons and alpha particles are addressed in the Tables 1004(b).1 and 2 in 10 CFR §20.1004.

2 Agreement States

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Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional Offices. Any applicant other than a Federal agency who wishes to possess or use licensed material in one of these Agreement States needs to contact the responsible officials in that State for guidance on preparing an application; file these applications with State officials, not with the NRC.

In general, NRC's materials licensees who wish to conduct operations at temporary job sites in an Agreement State should contact that State's radiation control program office for information about State regulations. To ensure compliance with Agreement State reciprocity requirements, a licensee should request authorization well in advance of scheduled use.

In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. NRC has regulatory authority over land determined to be "exclusive Federal jurisdiction," while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal agency controlling the site (e.g., contract officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determining jurisdictional status is found in All Agreement States Letter, SP-96-022, dated February 16, 1996, which is available as indicated below. Table 2-1 provides a quick way to check on which agency has regulatory authority.

Table 2.1 Who Regulates the Activity?

Figure 2.1 U.S. Map. Location of NRC Offices and Agreement States.

References: A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) is available by choosing "Directories" on the NRC Office of State and Tribal Programs' (OSP) Home Page <http://www.hsrd.ornl.gov/nrc/home.html> As an alternative, request the list from NRCs Regional Offices.

All Agreement States Letter, SP-96-022, dated February 16, 1996, is available on the OSP Home Page at <http://www.hsrd.ornl.gov/nrc/home.html> choose "NRC-State Communications," then choose "All of the Above" and follow the directions for submitting a query for "SP96022." As an alternative, request the list from OSP; call NRC's toll free number (800) 368-5642 and then ask for extension 415-3340.

3 Management Responsibility

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The NRC recognizes that effective radiation safety program management is vital to achieving safe and compliant operations. NRC also believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely. NRC also believes that effective management will result in increased safety and compliance.

To ensure adequate management involvement, a duly authorized management representative must sign the submitted application acknowledging management's commitments and responsibility for the following:

• Radiation safety, security and control of radioactive materials, and compliance with regulations;

• Completeness and accuracy of the radiation safety records and all information provided to NRC (10 CFR 30.9);

• Knowledge about the contents of the license and application;

• Compliance with current NRC and Department of Transportation (DOT) regulations and the licensee's operating and emergency procedures;

• Commitment to provide adequate resources (including space, equipment, personnel, time, and, if needed, contractors) to the radiation protection program to ensure that public and workers are protected from radiation hazards and meticulous compliance with regulations is maintained;

• Selection and assignment of a qualified individual to serve as the Radiation Safety Officer (RSO) for their licensed activities;

• Prohibition against discrimination of employees engaged in protected activities (10 CFR 30.7);

• Commitment to provide information to employees regarding the employee protection and deliberate misconduct provisions in 10 CFR 30.7 and 10 CFR 30.10, respectively;

• Obtaining NRC's prior written consent before transferring control of the license; and

• Notifying appropriate NRC regional administrator in writing, immediately following filing of petition for voluntary or involuntary bankruptcy (10 CFR 30.34(h)).

For information on NRC inspection, investigation, enforcement, and other compliance programs, see the current version of "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, and Inspection Procedure (IP) 87110, Appendix A, "Industrial/Academic/Research Inspection Field Notes." These documents are available electronically at <http://www.nrc.gov>. For hard copies of NUREG-1600 and IP 87110, see the Notice of Availability (on the inside front cover of this report).

4 Applicable Regulations

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It is the applicant's or licensee's responsibility to have up-to-date copies of applicable regulations, read them, and abide by each applicable regulation.

The following Parts of 10 CFR Chapter I contain regulations applicable to fixed gauges:

• 10 CFR Part 2, "Rules of Practice for Domestic Licensing Proceedings and Issuance of Orders"
• 10 CFR Part 19, "Notices, Instructions and Reports to Workers: Inspection and Investigations"
• 10 CFR Part 20, "Standards for Protection Against Radiation"
• 10 CFR Part 21, "Reporting of Defects and Noncompliance"
• 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material"
• 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material"
• 10 CFR Part 71, "Packaging and Transportation of Radioactive Material"

• 10 CFR Part 150, "Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under Section 274"
• 10 CFR Part 170, "Fees for Facilities, Materials, Import and Export Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended"
• 10 CFR Part 171, "Annual Fees for Reactor Operating Licenses, and Fuel Cycle Licenses and Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by NRC"

To request copies of the above documents, call GPO's order desk in Washington, DC at (202) 512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact the GPO electronically at <http://www.gpo.gov> . Request single copies of the above documents from NRC's Regional Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC and all other Federal Agencies publish amendments to regulations in the Federal Register .

5 How to File

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5.1 Paper Application

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Applicants for a materials license should do the following:

• Be sure to use the most recent guidance in preparing an application.
• Complete NRC Form 313 (Appendix A) Items 1 through 4, 12, and 13 on the form itself.
• Complete NRC Form 313 Items 5 through 11 on supplementary pages or use Appendix B.
• For each separate sheet, other than Appendix B, that is submitted with the application, identify and key it to the item number on the application or the topic to which it refers.
• Submit all documents on 8-1/2 x 11 inch paper.
• Avoid submitting proprietary information unless it is absolutely necessary.
• Submit an original application and one copy.
• Retain one copy of the license application for future reference. Applicants for a materials license should do the following:

All license applications will be available for review by the general public in NRC's Public Document Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, social security number, date of birth, radiation dose information, should not be submitted unless specifically requested by NRC.

As explained in the Foreword to this document, NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications. However, these will be scanned and put through an optical character reader to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:

• Submit printed or typewritten, not handwritten, text on smooth, crisp paper that will feed easily into the scanner.
• Choose typeface designs that are sans serif, such as Arial, Futura, Univers; the text of this document is in a serif font called Times New Roman.
• Choose 12-point or larger font size.
• Avoid stylized characters such as script, italic, etc.
• Be sure the print is clear and sharp.
• Be sure there is high contrast between the ink and paper (black ink on white paper is best).

5.2 Electronic Application

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As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or CD-ROM, and through the Internet. Additional filing instructions will be provided as these new mechanisms become available. The existing paper process will be used until the electronic process is available.

6 Where to File

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Applicants wishing to possess or use licensed material in any State or U.S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States.

In general, applicants wishing to possess or use licensed material in Agreements States must file an application with the Agreement State, not NRC. However, if work will be conducted at Federally controlled sites in Agreement States, applicants must first determine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See the section on "Agreement States" for additional information.

7 License Fees

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Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application.

Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for additional information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as "small entities."

Direct all questions about NRC's fees or completion of Item 12 of NRC Form 313 (Appendix A) to the Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, (301) 415-7554. You may also call NRC's toll free number (800) 368-5642 and then ask for extension 415-7554.

8 Contents of an Application

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

8.1 Item 1: License Action Type

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THIS IS AN APPLICATION FOR (Check appropriate item):

Check box A for a new license request.
Check box B for an amendment⁽¹⁾ to an existing license, and provide license number.
Check box C for a renewal¹ of an existing license, and provide license number.

8.2 Item 2: Applicant's Name and Mailing Address

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List the legal name of the applicant's corporation or other legal entity with direct control over use of the radioactive material; a division or department within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A post office box number is an acceptable mailing address.

Notify NRC of changes in mailing address; these changes do not require a fee.

Note: NRC must be notified before control of the license is transferred or bankruptcy proceedings have been initiated; see below for more details. NRC Information Notice (IN) 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability.

Timely Notification of Transfer of Control

Regulations: 10 CFR 30.34(b).

Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, or, as some licensees call it, "transferring the license."

Discussion: Transfer of control may be the result of mergers, buyouts, or majority stock transfers. Although it is not NRC's intent to interfere with the business decisions of licensees, it is necessary for licensees to obtain prior NRC written consent before the transaction is finalized.

This is to ensure the following:

• Radioactive materials are possessed, used, or controlled only by persons who have valid NRC licenses;
• Materials are properly handled and secured;
• Persons using these materials are competent and committed to implementing appropriate radiological controls;
• A clear chain of custody is established to identify who is responsible for disposition of records and licensed material; and

• Public health and safety are not compromised by the use of such materials.

Response from Applicant: None from an applicant for a new license; Appendix C, excerpted from IN 89-25, Revision 1, "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, identifies the information to be provided about transfers of control.

References: See Notice of Availability (on the inside front cover of this report) to obtain copies of IN 89-25, Revision 1, "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, and IN 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997.

Notification of Bankruptcy Proceedings

Regulations: 10 CFR 30.34(h).

Criteria: Immediately following filing of voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing.

Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and adequately controlled and whether there are any public health and safety concerns (e.g., contaminated facility). NRC shares the results of its determinations with other involved entities (e.g., trustee) so that health and safety issues can be resolved before bankruptcy actions are completed.

Response from Applicant: None at time of application for a new license. Generally, licensees should notify NRC within 24 hours of filing a bankruptcy petition.

References: INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov.> For hard copies, see the Notice of Availability (on the inside front cover of this report).

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

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Specify the street address, city, and state or other descriptive address (such as on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each facility. The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A Post Office Box address is not acceptable.

An NRC-approved license amendment is required before locating a gauge at an address not already listed on the license, whether that gauge is an additional unit or a relocation of an existing unit.

For information on conducting operations at temporary job sites (i.e., locations where work is conducted for limited periods of time, refer to the section in this report called "Fixed Gauges Used at Temporary Job Sites." That section offers examples of operations where fixed gauges might be used at temporary job sites and gives information which should be provided to the NRC to support a request for these operations.

Note: As discussed later in the section "Financial Assurance and Record Keeping for Decommissioning," licensees do need to maintain permanent records on where licensed material was used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). For fixed gauge licensees, acceptable records are sketches or written descriptions of specific locations where each gauge was used or stored and any information relevant to damaged devices or leaking radioactive sources.

8.4 Item 4: Person to Be Contacted about this Application

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Identify the individual who can answer questions about the application and include his or her telephone number. This is typically the proposed radiation safety officer, unless the applicant has named a different person as the contact. The NRC will contact this individual if there are questions about the application.

Notify NRC if the contact person or his or her telephone number changes so that NRC can contact the applicant or licensee in the future with questions, concerns, or information. This notice is for "information only" and does not require a license amendment or a fee.

8.5 Item 5: Radioactive Material

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8.5.1 Sealed Sources and Devices

Regulations: 10 CFR 30.32(g), 10 CFR 30.33(a)(2), 10 CFR 32.210.

Criteria: Applicants must provide the manufacturer's or distributor's name and model number for each requested sealed source and device. Licensees will be authorized to possess and use only those sealed sources and devices specifically approved or registered by NRC or an Agreement State.

Discussion: NRC or an Agreement State performs a safety evaluation of fixed gauges before authorizing a manufacturer or distributor to distribute the gauges to specific licensees. The safety evaluation is documented in a Sealed Source and Device (SSD) Registration Certificate. Before the SSD registration process was formalized, some older gauges may not have been evaluated in a separate document, but were specifically approved on a license. Licensees can continue to use these gauges that are specifically listed on their licenses. Some examples of fixed gauges are shown in Figure 8.1.

Figure 8.1 Examples of Several Different Types of Fixed Gauges.

Consult with the proposed manufacturer or distributor to ensure that requested sources and devices are compatible and conform to the sealed source and device designations registered with NRC or an Agreement State. Licensees may not make any changes to the sealed source, device, or source/device combination that would alter the description or specifications from those indicated in the respective registration certificates, without obtaining NRC's prior permission in a license amendment. Such changes may necessitate a custom registration review, increasing the time needed to process a licensing action.

SSD Registration Certificates contain sections on "Conditions of Normal Use" and "Limitation and Other Considerations of Use." These sections may include limitations derived from conditions imposed by the manufacturer or distributor, by particular conditions of use that would reduce radiation safety of the device, or by circumstances unique to the sealed source or device. For example, working life of the device or appropriate temperature and other environmental conditions may be specified. Except as specifically approved by NRC, licensees are required to use gauges according to their respective SSD Registration Certificates. Accordingly, applicants may want to obtain a copy of the certificate and review it with the manufacturer or distributor or with NRC or the issuing Agreement State to ensure that it correctly reflects the radiation safety properties of the source or device. See Appendix E for an example of a fixed gauge SSD Registration Certificate.

Response from Applicant:

• Identify each radionuclide that will be used in each source in the gauging device(s).
• Identify the manufacturer or distributor and model number of each type of sealed source and device requested.
• Confirm that each sealed source, device, and source/device combination is registered as an approved sealed source or device by NRC or an Agreement State.
• Confirm that the activity per source and maximum activity per device will not exceed the maximum activity listed on the approved certificate of registration issued by NRC or by an Agreement State.

Note: For information on SSD registration certificates, contact the Registration Assistant by calling NRC's toll free number (800) 368-5642 and then asking for extension 415-7217. For more information about the SSD registration process, see the current version of NUREG-1556, Vol. 3, "Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration." It is available electronically in the "Reference Library" at <http://www.nrc.gov>; for a paper copy, see the Notice of Availability (on the inside front cover of this report).

8.5.2 Financial Assurance and Recordkeeping for Decommissioning

Regulations: 10 CFR 30.34(b), 10 CFR 30.35.

Criteria: Fixed gauge licensees authorized to possess sealed sources containing radioactive material in excess of the limits specified in 10 CFR 30.35(b) and (d) must provide evidence of financial assurance for decommissioning.

Even if no financial assurance is required, licensees are required to maintain, in an identified location, decommissioning records related to structures and equipment where gauges are used or stored and to leaking sources. Pursuant to 10 CFR 30.35(g), licensees must transfer these records important to decommissioning to either of the following:

• The new licensee before licensed activities are transferred or assigned according to 10 CFR 30.34(b).

The appropriate NRC regional office before the license is terminated.

Discussion: The requirements for financial assurance are specific to the types and quantities of byproduct material authorized on a license. Most fixed gauge applicants and licensees do not need to take any action to comply with the financial assurance requirements because their total inventory of licensed material does not exceed the thresholds in 10 CFR 30.35(b) and (d). The thresholds for typical radionuclides used for fixed gauge sealed sources are shown in Table 8.1.

Table 8.1 Examples of Minimum Inventory Quantities Requiring Financial Assurance

A licensee would need to possess hundreds of gauges before the financial assurance requirements would apply. Since the standard gauge license does not specify the maximum number of gauges that a licensee may possess (allowing flexibility in obtaining additional gauges specifically authorized by the license as needed without amending its license), it contains a condition requiring the licensee to limit its possession of fixed gauges to quantities not requiring financial assurance. Applicants and licensees desiring to possess gauges exceeding the threshold amounts must submit evidence of financial assurance.

Applicants requesting more than one radionuclide may determine whether financial assurance for decommissioning is required by calculating, for each radionuclide possessed, the ratio between the activity possessed, in curies, and the radionuclide's threshold activity requiring financial assurance, in curies. If the sum of such ratios for all of the radionuclides possessed exceeds "1" (i.e., "unity"), then applicants must submit evidence of financial assurance for decommissioning.

The same regulation also requires that licensees maintain records important to decommissioning in an identified location. All fixed gauge licensees need to maintain records of structures and equipment where each gauge was used or stored. As-built drawings with modifications of structures and equipment shown as appropriate fulfill this requirement. If drawings are not available, licensees shall substitute appropriate records (e.g., a sketch of the room or building or a narrative description of the area) concerning the specific areas and locations. If no records exist regarding structures and equipment where gauges were used or stored, licensees shall make all reasonable efforts to create such records based upon historical information (e.g. employee recollections). In addition, if fixed gauge licensees have experienced unusual occurrences (e.g., leaking sources, other incidents that involve spread of contamination), they also need to maintain records about contamination that remains after cleanup or that may have spread to inaccessible areas.

Response from Applicant: No response is needed from most applicants. If financial assurance is required, submit the documentation required under 10 CFR 30.35. RG 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, contains approved wording for each of the mechanisms authorized by the regulation to guarantee or secure funds except for the Statement of Intent for Government licensees.

References: See Notice of Availability (on the inside front cover of this report) to obtain copies of RG 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, and P&GD FC 90-2, Revision 1, "Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30, 1991.

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

Regulations: 10 CFR 30.33(a)(1).

Criteria: Proposed purpose is authorized by the Atomic Energy Act of 1954, as amended. Gauges should be used only for the purposes for which they were designed, according to the manufacturer's or distributor's recommendations and instructions, as specified in an approved SSD Registration Certificate, and as authorized on an NRC license.

Discussion: Uses other than those listed in the SSD Registration Certificate require review and approval by the NRC or an Agreement State. Requests to use fixed gauges for purposes not listed in the SSD Registration Certificate will be reviewed on a case-by-case basis. Applicants need to submit sufficient information to demonstrate that the proposed use will not compromise the integrity of the source or source shielding, or other radiation safety-critical components of the device. NRC will evaluate the radiation safety program for each type and use of gauge requested.

Response from Applicant: Provide either of the following:

• If the fixed gauge(s) will be used for the purposes listed on the SSD Registration Certificate, do the following:
• State that "The fixed gauge(s) will be used for the purposes described on the SSD Registration Certificate(s)"
• Provide a specific description of use for each type of gauge requested, e.g., "for use in measuring the thickness of paper, the bulk density and weight of coal on a beltscale, etc."

OR

• If the fixed gauge will be used for purposes other than those listed on the SSD Registration Certificate, specify these other purposes and submit safety analyses (and procedures, if needed) to support safe use.

Note:

• Allowed uses of fixed gauges normally include process control methods such as measuring the thickness of paper, the density of coal, the level of material in vessels and tanks, etc.

• Unusual uses will be evaluated on a case-by-case basis and the authorized use condition will reflect approved uses.

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

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8.7.1 Radiation Safety Officer (RSO)

Regulations: 10 CFR 30.33(a)(3).

Criteria: Radiation Safety Officers (RSOs) must have adequate training and experience. Successful completion of training of one of the following is evidence of adequate training and experience.

• Fixed gauge manufacturer's or distributors course for users or for RSOs

• Equivalent course that meets Appendix G criteria

Additional training is required for RSOs of programs that perform non-routine operations. This includes repairs involving or potentially affecting components related to the radiological safety of the gauge (e.g., the source, source holder, source drive mechanism, shutter, shutter control, or shielding) and any other activities during which personnel could receive radiation doses exceeding NRC limits (e.g., installation, initial radiation survey, gauge relocation, and removal of the gauge from service). See "Radiation Safety Program - Maintenance" in this report and Appendix N, "Non Routine Operations."

Discussion: The person responsible for the radiation protection program is called the Radiation Safety Officer (RSO). The RSO needs independent authority to stop operations that he or she considers unsafe. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are used in a safe manner. Typical RSO duties are illustrated in Figure 8.2 and described in Appendix F. NRC requires the name of the RSO on the license to ensure that licensee management has always identified a responsible, qualified person and that the named individual knows of his or her designation as RSO.

Figure 8.2 RSO Responsibilities. Typical duties and responsibilities of RSOs.

Response from Applicant: Provide the following:

• Name of the proposed RSO;

AND EITHER

• Statement that "Before obtaining licensed materials, the proposed RSO will have successfully completed the training described in Criteria in the section entitled 'Radiation Safety Officer' in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauges Licenses,' dated October 1998"; and

• Statement that "Before being named as the RSO, future RSOs will have successfully completed the training described in Criteria in the section entitled 'Radiation Safety Officer' in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauges Licenses,' dated October 1998. Within 30 days of naming a new RSO, we will submit the new RSO's name to NRC to include in our license."

OR

• Alternative information demonstrating that the proposed RSO and any future RSO are qualified by training and experience.

Note:

• It is important to notify NRC, as soon as possible, of changes in the designation of the RSO; such notifications will be handled as administrative amendments not requiring fees as long as the application contains the commitment listed in the third bullet under "Response from Applicant."

• Alternative responses will be evaluated using the criteria listed above.

8.7.2 Authorized Users

Regulations: 10 CFR 30.33(a)(3).

Criteria: Authorized users (AUs) must have adequate training and experience. Successful completion of one of the following is evidence of adequate training and experience:

• Fixed gauge manufacturer's or distributors course for users
• Equivalent course that meets Appendix G criteria

Applicants requesting to perform non-routine operations such as installation, initial radiation survey, repair, and maintenance of components related to the radiological safety of the gauge, gauge relocation, replacement and disposal of sealed sources, alignment, or removal of a gauge from service, must provide additional training. See the section in this report titled "Radiation Safety Program - Maintenance" and Appendix N.

Discussion: An AU is a person whose training and experience meet NRC criteria, who is named either explicitly or implicitly on the license, and who uses or directly supervises the use of licensed material. AUs must ensure the proper use, security, and routine maintenance of fixed gauges containing licensed material. AUs must attend the training and instruction given at the time of installation or receive equivalent training and instruction.

An AU is considered to be supervising the use of licensed material when he or she directs personnel in operations involving the material. Although the AU may delegate specific tasks to supervised users (e.g., maintaining records), he or she is still responsible for safe use of licensed material.

Response from Applicant: Provide either of the following:

• The statement "Before using licensed materials, authorized users will have successfully completed one of the training courses described in Criteria in the section entitled 'Authorized Users' in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauge Licenses,' dated October 1998."

OR

• A description of the training and experience for proposed authorized users.

Note: Alternative responses will be evaluated using the criteria listed above.

8.8 Item 8: Training for Individuals Who in the Course of Employment Are Likely to Receive Occupational Doses of Radiation in Excess of 1 Msv (100 Mrem) in a Year (Occupationally Exposed Workers) and Ancillary Personnel

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Regulations: 10 CFR 19.11, 10 CFR 19.12, 10 CFR 19.13, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.7, 10 CFR 30.9, 10 CFR 30.10, 10 CFR 30.33.

Criteria: Individuals who in the course of employment are likely to receive occupational doses of radiation in excess of 1 mSv (100 mrem) in a year must receive training according to 10 CFR 19.12. The extent of this training must be commensurate with potential radiological health protection problems present in the work place.

Discussion: Licensees need to perform a prospective evaluation to determine radiation doses likely to be received by different individuals or groups. AUs, and individuals performing installations, relocations, non-routine maintenance, or repairs would be most likely to receive doses in excess of 1 mSv (100 mrem) in a year. See the previous section for a discussion of training and experience for Aus. Licensee personnel who work in the vicinity of a fixed gauge but do not use gauges (ancillary staff) are not required to have radiation safety training as long as they are not likely to receive 1 mSv (100 mrem) in a year. However, to minimize potential radiation exposure when ancillary staff are working in the vicinity of a fixed gauge, it is prudent for them to work under the supervision and in the physical presence of an AU or to be provided some basic radiation safety training. Such ancillary staff should be informed of the nature and location of the gauge and the meaning of the radiation symbol, and should be instructed not to touch the gauge and to keep away from it as much as their work permits.

Some ancillary staff, although not likely to receive doses over 1 mSv (100 mrem), should receive training to ensure adequate security and control of licensed material. Licensees may provide these individuals with training commensurate with their assignments in the vicinity of the gauge, to ensure the control and security of licensed material.

Response from Applicant: The applicant's training program, for individuals who in the course of employment are likely to receive occupational doses of radiation in excess of 1 mSv (100 mrem) in a year (occupationally exposed workers) and ancillary personnel, will be examined during inspections, but should not be submitted in the license application.

8.9 Item 9: Facilities and Equipment

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Regulations: 10 CFR 30.33(a)(2), 10 CFR 32.210.

Criteria: Facilities and equipment must be adequate to protect health and to minimize danger to life or property. This may be demonstrated by the following:

• The location of the gauge is compatible with the "Conditions of Normal Use" and "Limitations and/or Other Considerations of Use" on the SSD Registration Certificate
• The fixed gauge is secured to prevent unauthorized removal or access (e.g., located in a locked room, permanently mounted, or chained and locked to a storage rack).

Discussion: Fixed gauges incorporate many engineering features to protect the user from unnecessary radiation exposure in a wide variety of environments. Fixed gauges may be located in harsh environments involving variables such as pressure, vibration, mounting height/method, temperature, humidity, air quality, corrosive atmospheres, corrosive chemicals including process materials and cleaning agents, possible impact or puncture conditions, and fire, explosion, and flooding potentials. Applicants need to consult the sections on the SSD Registration Certificate, "Conditions of Normal Use" and "Limitations and/or Other Considerations of Use" to determine the appropriate gauge for a location. In those instances when a proposed location is not consistent with the SSD Registration Certificate, the applicant may ask the source or device manufacturer or distributor to request an amendment to modify the SSD Registration Certificate to include the new conditions. If the manufacturer or distributor does not request an amendment, the applicant must provide the NRC with specific information demonstrating that the proposed new conditions will not impact the safety or integrity of the source or device.

Response from Applicant: Provide one of the following:

• A statement that "We will ensure that the location of each fixed gauge meets the criteria in the section entitled 'Facilities and Equipment' in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauge Licenses,' dated October 1998."

OR

• Confirm that the fixed gauge is secured to prevent unauthorized removal or access; and submit specific information demonstrating that the proposed conditions will not impact the safety or integrity of the source or device. Address any instances where the proposed conditions exceed any conditions listed in the SSD Registration Certificate.

Note:

• Any deviations from an SSD Registration Certificate will require specific NRC approval.

• Alternative responses will be evaluated using the criteria listed above.

References: INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. For hard copies, see the Notice of Availability (on the inside front cover of this report).

8.10 Item 10: Radiation Safety Program

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8.10.1 Audit Program

Regulations: 10 CFR 20.1101, 10 CFR 20.2102.

Criteria: Licensees must review the content and implementation of their radiation protection programs at intervals not to exceed 12 months to ensure the following:

• Compliance with NRC and DOT regulations (as applicable), and the terms and conditions of the license;
• Occupational doses and doses to members of the public are ALARA (10 CFR 20.1101); and
• Records of audits and other reviews of program content are maintained for 3 years.

Discussion: Appendix H contains a suggested audit program that is specific to the use of fixed gauges and is acceptable to NRC. All areas indicated in Appendix H may not be applicable to every licensee and all items may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities, and activities which have not occurred since the last audit need not be reviewed at the next audit. Currently the NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits of fixed gauge users to determine if, for example, Operating and Emergency Procedures are available and are being followed, etc.

It is essential that once identified, problems be corrected comprehensively and in a timely manner; IN 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," provides guidance on this subject. The NRC will review the licensee's audit results and determine if corrective actions are thorough, timely, and sufficient to prevent recurrence. If violations are identified by the licensee and these steps are taken, the NRC will normally exercise discretion and may elect not to cite a violation. The NRC's goal is to encourage prompt identification and prompt, comprehensive correction of violations and deficiencies. For additional information on NRC's use of discretion on issuing violations, refer to the current version of NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions." Licensees must maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. NRC has found audit records that contain the following information to be acceptable: date of audit, name of person(s) who conducted audit, persons contacted by the auditor(s), areas audited, audit findings, corrective actions, and follow-up.

Response from Applicant: The applicant's program for reviewing the content and implementation of its radiation protection program will be examined during inspections, and should not be submitted in the license application.

References: The current version of NUREG-1600 is available electronically at <http://www.nrc.gov/OE>. INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. For hard copies of NUREG-1600, IN 96-28, and IP 87110, Appendix A, "Industrial/Academic/Research Inspection Field Notes," see the Notice of Availability (on the inside front cover of this report).

8.10.2 Instruments

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

Criteria: Licensees must possess, or have access to, radiation monitoring instruments which are necessary to protect health and minimize danger to life or property. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured.

Discussion: Usually it is not necessary for fixed gauge licensees to possess a survey meter. However, surveys according to 10 CFR 20.1501 will be required if an applicant plans to conduct non-routine operations. This includes installation, initial radiation surveys, relocation, removal from service, dismantling, alignment, replacement, disposal of the sealed source, and non-routine maintenance and repair of components related to the radiological safety of the gauge. Because some of these operations may increase the risk of radiation exposure, individuals performing these operations should be carefully monitored with a survey meter. Such survey meters should be properly calibrated. Proper calibration is particularly important for initial surveys since the results can be used as a basis for public dose estimates. For those licensees requesting authorization to calibrate their own survey instruments, Appendix I contains calibration procedures acceptable to the NRC. Licensees who perform surveys pursuant to 10 CFR 20.1501 must possess a survey meter that

• Measures at least 0.3 through 1 through 200 mR per hour (50 microcoulombs per kilogram)
• Is capable of measuring the radiation being emitted from the gauges sealed source
• Is checked for functionality with a source of radiation at the beginning of each day of use (e.g., with the gauge or a check source)
• Is calibrated
• At intervals not to exceed 12 months
• Using a source of radiation similar to those found in the gauges
• To ensure that exposure rates indicated by the meter do not vary from the actual exposure rates by more than ± 20% on each scale
• After any servicing or repair (other than a simple battery exchange)

By the instrument manufacturer or person specifically authorized by the NRC or an Agreement State Since many fixed gauge licensees are not required to possess a survey meter, applicants should preplan how they will obtain assistance in performing a radiation survey in the event of an emergency (e.g., obtain a survey instrument from hospitals, universities, other NRC or Agreement State licensees, or local emergency response organization). It is important to determine as soon as possible after an incident, by the use of a radiation survey meter, whether the shielding and source are intact.

For those licensees using gauges containing only beta, neutron or alpha-emitting radionuclides, specialized survey instruments may be required.

Response from Applicant: Provide one of the following:

• A statement that "Surveys according to 10 CFR 20.1501 will be performed by a person specifically authorized by the NRC or an Agreement State to perform these surveys."

OR

• A statement that "We will use survey instruments that meet the Criteria in the section entitled 'Radiation Safety Program - Instruments' in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauge Licenses,' dated October 1998"; and one of the following three choices:
• "Each survey meter will be calibrated by the manufacturer or other person authorized by the NRC or an Agreement State to perform survey meter calibrations."

OR

• "We will implement the model survey meter calibration program published in Appendix I entitled 'Survey Instrument Calibration' in NUREG-1556, Vol. 4, 'Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Fixed Gauge Licenses,' dated October 1998."

OR

• "We will submit alternative calibration procedures for NRC review."

OR, IN LIEU OF ALL OF THE ABOVE

• Submit a description of an alternative method to perform surveys according to 10 CFR 20.1501.

Notes:

• Alternative responses will be reviewed against the criteria listed above.
• The NRC license will state that survey meter calibrations will be performed by the instrument manufacturer or a person specifically authorized by the NRC or an Agreement State, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey meter calibrations must submit additional information for review. See Appendix I for more information.
• Regardless of whether an applicant is authorized to calibrate survey meters or contracts an authorized firm to perform calibrations, the licensee must retain calibration records for at least 3 years.

8.10.3 Material Receipt and Accountability

Regulations: 10 CFR 30.34(e), 10 CFR 30.41, 10 CFR 30.51, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2201.

Criteria: Licensees must do the following:

• Maintain records of receipt, transfer, and disposal of fixed gauges and
• Conduct physical inventories at intervals not to exceed 6 months, or some other interval justified by the applicant and approved by NRC, to account for all sealed sources.

Discussion: As illustrated in Figure 8.3, licensed materials must be tracked from "cradle to grave" in order to ensure gauge accountability, identify when gauges could be lost, stolen, or misplaced, and ensure that possession limits listed on the license are not exceeded. Significant problems can arise from failure to ensure the accountability of gauges. See IN 88-02, "Lost or Stolen Gauges," dated February 2, 1988.

Figure 8.3 Material Receipt and Accountability. Licensees must maintain records of receipt, transfer, and disposal and conduct semiannual physical inventories.

Receipt, transfer, and disposal records must be maintained for the times specified in Table 8-2. Typically, these records contain the following types of information:

• Radionuclide and activity (in units of becquerels or curies) of byproduct material in each sealed source
• Manufacturer's or distributor's name, model number, and serial number (if appropriate) of each device containing byproduct material
• Location of each sealed source and device
• For materials transferred or disposed of, the date of the transfer or disposal, name and license number of the recipient, description of the affected radioactive material (e.g., radionuclide, activity, manufacturer's or distributor's name and model number, serial number).

Table 8.2 Record Maintenance

Response from Applicant: Provide either of the following:

• A statement that "Physical inventories will be conducted at least every 6 months or at other intervals approved by the NRC, to account for all sealed sources and devices received and possessed under the license."

OR

• A description of the procedures for ensuring that no fixed gauge has been lost, stolen, or misplaced and how often they will be conducted.

Note:

• Alternative responses will be evaluated using the criteria listed above.

• Inventory records should be maintained and contain the following types of information:
• Radionuclide and amount (in units of becquerels or curies) of byproduct material in each sealed source
• Manufacturer's or distributors name, model number, and serial number (if appropriate) of each device containing byproduct material
• Location of each sealed source and device
• Date of the inventory
• Signature of the individual conducting the inventory.

References: INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. For hard copies, see the Notice of Availability (on the inside front cover of this report).

8.10.4 Occupational Dose

Regulations: 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR 20.1207, 10 CFR 20.1208.

Criteria: Applicants must do either of the following:

• Perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits as shown in Figure 8.4

OR

• Provide dosimetry processed and evaluated by a National Voluntary Laboratory Accreditation Program (NVLAP) approved processor that is exchanged at a frequency recommended by the processor.

Figure 8.4 Annual Dose Limits for Occupationally Exposed Adults.

Discussion: Under conditions of routine use, the typical fixed gauge user does not require a personnel monitoring device (dosimetry). A gauge user also does not require dosimetry when proper emergency procedures are used. Appendix J provides guidance on performing a prospective evaluation demonstrating that fixed gauge users are not likely to exceed 10% of the limits as shown in Figure 8.4 and thus, are not required to have personnel dosimetry.

Individuals who perform non-routine operations such as installation, initial radiation survey, repair, and maintenance of components related to the radiological safety of the gauge, gauge relocation, replacement, and disposal of sealed sources, alignment, or removal of a gauge from service are more likely to exceed 10% of the limits as shown in Figure 8.4. Applicants may be required to provide dosimetry (whole body and perhaps extremity monitors) to individuals performing such services or must perform a prospective evaluation demonstrating that unmonitored individuals performing such non-routine operations are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limits as shown in Figure 8.4.

When personnel monitoring is needed, most licensees use either film badges or thermoluminescent dosimeters (TLDs) that are supplied by a NVLAP-approved processor. The exchange frequency for film badges is usually monthly due to technical concerns about film fading. The exchange frequency for TLDs is usually quarterly. Applicants should verify that the processor is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations for exchange frequency and proper use.

Response from Applicant: Provide one of the following:

• A statement that "We will perform a prospective evaluation demonstrating that unmonitored individuals are not likely to receive, in one year, a radiation dose in excess of 10% of the allowable limit