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Applications for Sealed Source and Device Evaluation and Registration - Final Report (NUREG-1556, Vol. 3)

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Table of Contents

• Publication Information
• Abstract
• Foreword
• Figures
• Acknowledgments
• The Participants
• Abbreviations
• 1 Purpose of Draft Report
• 2 Agreement States
• 3 Management Responsibility
• 4 Applicable Regulations
• 4.1 Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 for use by Persons Exempt from Licensing Requirements
• 4.2 Gas and Aerosol Detectors Containing Byproduct Material for use by Persons Exempt from Licensing Requirements
• 4.3 Devices Used Under the General License in 10 CFR 31.5
• 4.4 Luminous Safety Devices Used in Aircraft Under 10 CFR 31.7
• 4.5 Ice Detection Devices Containing Strontium-90
• 4.6 Radiography Equipment
• 4.7 Well-Logging Equipment
• 4.8 Irradiators
• 4.9 Sealed Sources and Devices for Medical Use
• 5 General Policies and Procedures
• 5.1 Sealed Source and Device Designs that do not Require Evaluation by IMNS
• 5.1.1 Calibration and Reference Standards
• 5.1.2 Products used in Research and Development or by Broad Scope Licensees
• 5.1.3 Custom Sealed Sources or Devices
• 5.2 Custom Users
• 5.3 As Low as is Reasonably Achievable
• 5.4 Naturally Occurring or Accelerator-Produced Radioactive Material
• 5.5 Foreign Vendors
• 5.6 Use of International or Foreign Standards
• 5.7 FDA-NRC Memorandum of Understanding
• 5.8 Computer Software
• 5.9 Registration Certificate Revocation
• 5.10 Incidents
• 5.11 Proprietary Information
• 5.12 Transportation
• 6 How to File
• 7 Where to File
• 8 Registration Fees
• 9 Document Flow
• 9.1 Application Receipt and Assignment to a Reviewer
• 9.2 Reviewer's Responsibilities
• 9.3 Distribution of Completed Certificates
• 9.4 Inclusion in the Sealed Source and Device Computerized Registration System
• 10 Contents of the Application and the Review Process
• 10.1 Summary Information
• Manufacturer and Distributor
• Custom User
• Other Companies Involved
• Model Number, Sealed Source or Device Type, and Principal Use Code
• Radionuclides Used in the Product
• Leak Test Frequency
• Certification and Signature of a Management Representative
• 10.2 Conditions of Use
• 10.3 Construction of the Product
• 10.4 Labeling
• 10.5 Prototype Testing
• Sources
• Devices
• 10.6 Radiation Profiles
• 10.7 Quality Control and Quality Assurance
• 10.8 Installation, Servicing, and Instructions to Users
• 10.9 Final Evaluation and Concurrence
• 11 Deficiencies in the Application
• 11.1 Sending Deficiency Letters to Applicants
• 11.2 Meetings with Applicants
• 11.3 Use of the Telephone or Electronic Mail to Obtain Additional Information
• 11.4 Response Time Extensions
• 12 Contents of the Certificate
• 12.1 Header
• 12.2 First Page Information
• 12.3 Description
• 12.4 Labeling
• 12.5 Diagrams
• 12.6 Conditions of Normal Use
• 12.7 Prototype Testing
• 12.8 External Radiation Levels
• 12.9 Quality Assurance and Control
• 12.10 Limitations and other Consideration of Use
• 12.11 Safety Analysis Summary
• 12.12 References
• 12.13 Issuing Agency
• 12.14 Attachments
• 12.15 Dimensions and use of Dual Units
• 13 Modifications to Existing Registration Certificates
• 13.1 Amendments
• 13.2 Corrections
• 13.3 Combining Registration Certificates
• 13.4 Transfers to Inactive Status
• 13.5 Re-activating Inactive Registration Certificates
• 14 Identifying and Reporting Defects and Noncompliance as Required by 10 CFR Part 21
• 15 Glossary
• Appendix A: List of Approved Well-Logging Sources
• List of Approved Well-Logging Sources
• Appendix B: Checklist for Requests to Withhold Information from Public Disclosure
• Checklist for Requests to Withhold Information from Public Disclosure
• Appendix C: Application and Review Checklist
• Application and Review Checklist
• Appendix D: Memorandum From R. Scroggins Regarding Working on Applications Prior to Receipt of Fees
• Memorandum from R. Scroggins Regarding Working on Applications Prior to Receipt of Fees
• Appendix E: Principal Use Codes and Definitions
• Principal Use Codes and Definitions
• Appendix F: Standard Reference Materials
• Standard Reference Materials
• Appendix G: Industry and Consensus Standards
• Industry and Consensus Standards
• Appendix H: Standard Registration Certificate Formats
• Standard Registration Certificate Formats
• Appendix I: Assigning Registration Certificate Numbers
• Assigning Registration Certificate Numbers

Publication Information

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Manuscript Completed: July 1998
Date Published: July 1998

J. Lubinski, S. Baggett, D. Broaddus, M. Burgess, E. Compton, K. Randall, T. Rich, B. Smith

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

Abstract

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As part of its redesign of the materials licensing process, the United States 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," and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance." NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration," dated July 1998, is designed to provide applicants for requests for a sealed source or device safety evaluations. It also provides reviewers of such requests with the information and materials necessary to determine that the products are acceptable for licensing purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, certain administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

This document combines and supersedes the guidance previously found in NUREG-1550, "Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations," Regulatory Guide 10.10, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material," Regulatory Guide 10.11, "Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material," and the Office of Nuclear Material Safety and Safeguards Policy and Guidance Directives 84-22, "What Source and Device Designs Require an Evaluation," and 84-5, "Source and Device Evaluation Technical Assistance Request."

This report incorporates suggestions submitted during the comment period on draft NUREG-1556, Vol. 3. When published, this final report should be used in preparing sealed source and device applications. NRC staff will use this final report in reviewing these applications.

Foreword

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The NRC is using Business Process Redesign techniques to redesign its materials licensing process. This effort is described in NUREG-1539. 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:

NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration," dated July 1998, provides applicants requesting a sealed source or device safety evaluation, and reviewers of such requests, with the information and materials necessary to make determinations that the products are acceptable for licensing purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, certain administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

A team composed of NRC headquarters staff prepared NUREG-1556, Vol. 3, drawing on its collective experience in radiation safety in general and as specifically applied to sealed source and devices designs, and the experience gained through development and publication of NUREG-1550, "Standard Review Plan for Applications for Sealed Source and Device Evaluations and Registrations," that was published in 1996.

NUREG-1556, Vol. 3, 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 address: <http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v3/index.html>.

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 source and device registration. NUREG-1556, Vol. 3, 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 than those described in this report will be acceptable, if they provide enough information for the staff to make the determinations needed to issue, continue, or reject a license.

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

Figures

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2.1 U.S. Map. Location of NRC Offices and Agreement States. As of October 1, 1998, the Walnut Creek Field Office will close. All communications should be forwarded to Region IV.

4.1a Watches. Watches are products distributed to persons exempt from licensing under 10 CFR 30.19.

4.1b Aiming Sights. Aiming sights are products distributed to persons exempt from licensing under 10 CFR 30.19.

4.2a Smoke and Chemical Agent Detectors. Smoke and chemical agent detectors are products distributed to persons exempt from licensing under 10 CFR 30.20.

4.2b Smoke and Chemical Agent Detectors. Smoke and chemical agent detectors are products distributed to persons exempt from licensing under 10 CFR 30.20.

4.3a 10 CFR 31.5 General License. Gas chromatographs devices are products used under 10 CFR 31.5 general license.

4.3b 10 CFR 31.5 General License. Density gauge devices are products used under 10 CFR 31.5 general license.

4.3c 10 CFR 31.5 General License. Static elimination devices are products used under 10 CFR 31.5 general license.

4.4a 10 CFR 31.7 General License. Safety devices, such as exit signs, containing tritium or promethium-147 and used in aircraft may be used under 10 CFR 31.7 general license.

4.4b 10 CFR 31.7 General License. Safety devices, such as exit signs, containing tritium or promethium-147 and used in aircraft may be used under 10 CFR 31.7 general license.

4.5 Radiography Equipment. Radiography equipment, such as the equipment shown above, must meet the requirements of 10 CFR Part 34.

4.6 Well-Logging Operations. Sealed sources used in well-logging operations must meet the requirements of 10 CFR Part 39.

4.7a Irradiators. NRC evaluates (a) category I (self-shielded) irradiators used in category IV (Panoramic, wet source storage) irradiators.

4.7b Irradiators. NRC evaluates (b) sealed sources used in category IV (Panoramic, wet source storage) irradiators.

5.1 Calibration and Reference Sources. Calibration and reference sources may not need evaluation and registration by IMNS.

5.2 Map of the World. Foreign vendors are required to establish an address in the United States to which the NRC can correspond and serve papers as necessary to accomplish its mission.

5.3 Computer Software. Safety evaluations concentrate only on those systems that control fundamental safety processes such as checking an interlock, source or shielding position, and the functionality of position indicators.

5.4 Packaging and Transportation. Registration certificate holders must meet all NRC and DOT requirements for packaging and transporting sealed sources and devices.

10.1 Radiation Profiles. ANSI-538 suggests radiation profiles be provided as indicated above.

10.2 Installation and Servicing of Devices. Applicants must specify the qualifications needed by individuals to perform installation and servicing of devices.

Acknowledgments

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

The team also thanks Traci S. Kime and Mary Louise Roe of NRC, Angela S. Case of Total Systems Solutions, Inc., and Judy Boykin, Tina Jordan, D. W. Benedict Llewellyn, Alyce Martin, Steve Schawaroch, and Gina Thompson of Computer Sciences Corporation.

The Participants

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Baggett, Steven L.
Broaddus, Douglas A.
Burgess, Michele L.
Camper, Larry W.
Compton, Eric B.
Cool, Donald A.
Jankovich, John P.
Lee, Sueng J.
Lubinski, John W.
Randall, KimBerly B.
Rich, Thomas W.
Schwartz, Maria E.
Smith, Brian W.
Vacca, Patricia C.

Abbreviations

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1 Purpose of Draft Report

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This NUREG provides assistance to applicants on submitting requests to the NRC for radiation safety evaluation and registration of sealed sources and devices containing byproduct material. In addition, it is designed to provide the reviewer of such requests for sealed source and device safety evaluations with guidance, information, and materials necessary to make a determination that the product is acceptable for licensing purposes. It provides the applicants and reviewers with information concerning how to file a request, a listing of the applicable regulations and industry standards, policies affecting evaluation and registration, certain administrative procedures to be followed, information on how to perform the evaluation and write a registration certificate, and the responsibilities of the registration certificate holder.

Radiation safety programs for the use of byproduct material as a sealed source or device are structured on the presumption that the byproduct material will not breach its containment and contaminate the environment or unnecessarily expose individuals to radiation. This presumption depends largely upon the adequacy of the containment properties of the sealed sources or devices in withstanding the stresses imposed by the environment in which they are possessed and used.

The regulations provided in Title 10 of the Code of Federal Regulations (CFR), Section 30.32(g), require an applicant for a specific license to use a sealed source or device to identify the sealed source or device as registered with NRC in accordance with 10 CFR 32.210 or to provide the information contained in 10 CFR 32.210. 10 CFR 32.210 provides for the registration of a product and provides a means for having a single safety evaluation of the product performed. This process allows applicants and license reviewers to reference the evaluation when licensing the product for use or distribution without having to perform a complete evaluation of the product for each licensing action.

The NRC maintains a registry of radiation safety information on sealed sources and devices containing byproduct material. Agreement States also provide information on their radiation safety evaluations to the NRC for the registry. Both the NRC and the Agreement States use the information in the registry. Thus a vendor needs to provide detailed information about its sealed source or device only to a single agency, and the results of the radiation safety evaluation will be available for use in granting licensing approval to users of the device throughout the United States.

Any information collection activities mentioned in this document are contained as requirements in 10 CFR Parts 19, 20, 21, 30, 31, 32, 34, 35, 36, 39, 40, 70, and 71, which provide the regulatory basis for this document. The information collection requirements in these parts have been cleared under Office of Management and Budget Clearance Nos. 3150-0044, 3150-0014, 3150-0035, 3150-0017, 3150-0016, 3150-0001, 3150-0007, 3150-0010, 3150-0158, 3150-0130, 3150-0020, 3150-0009, and 3150-0008, respectively.

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 for certain activities, including performing safety evaluations and registration of byproduct, source, or special nuclear materials used, possessed, or distributed by persons within their borders. A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from the NRC's Office of State Programs (OSP). Any applicant, other than a Federal agency or distributor of a product to persons exempt from licensing, that is located in an Agreement State and wishes to apply for safety evaluation and registration of a sealed source or device 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. Table 2.1 provides a quick way to check on which agency has regulatory authority.

When an Agreement State issues a registration certificate, a copy of the registration certificate is forwarded to the Division of Industrial and Medical Nuclear Safety (IMNS) by the State. IMNS performs an administrative review of each certificate that includes looking for gross errors or omissions and ensures the inclusion of all necessary information on the first page of the certificate. The certificate is incorporated into the national registry, and copies are distributed to the NRC regions, all Agreement States, and appropriate Federal and international agencies. If any administrative problems or errors are identified with an Agreement State registration certificate, they are resolved directly with the Agreement State.

Agreement State regulations may vary from NRC regulations. As such, sealed sources or devices registered by an Agreement State may not have met the regulations required of an NRC licensee. In addition, the NRC may identify significant safety concerns about a sealed source or device that has been evaluated by an Agreement State. In these cases, IMNS will continue to incorporate the registration certificate into the national registry. However, a cover letter indicating why the sealed source or device is not approved for use by NRC licensees is attached to the registration certificate. IMNS will raise the safety issues with the State that issued the registration certificate and with the vendor through OSP. In addition, the NRC will attempt to obtain a listing of any NRC licensees that may have acquired the device and will take appropriate action. Corrective actions to resolve the registration issues, if any, will be the responsibility of the Agreement State.

The above process is necessary to: (1) ensure that NRC license reviewers are aware of particular NRC concerns with the registration certificate and (2) provide other Agreement States with the information necessary to determine whether a license to use the sealed source or device should be approved. If the registration certificates and cover letters are not included, an NRC or Agreement State license reviewer may receive a copy of the registration certificate directly from the registration certificate holder or an Agreement State and may inadvertently assume that products listed in the registration certificate are acceptable for licensing.

Table 2.1 Who Evaluates Sealed Sources and Devices?

Figure 2.1 U.S. Map. Location of NRC Offices and Agreement States. As of October 1, 1998, the Walnut Creek Field Office will close. All communications should be forwarded to Region IV.

3 Management Responsibility

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The NRC recognizes that effective applicant/registration certificate holder management is vital to achieving safety and complying with regulatory requirements. The NRC also believes that consistent compliance with its regulations provides reasonable assurance that regulated activities will be conducted accordingly. Based on results of routine and special inspections of licensed activities, the NRC has determined that ineffective management is frequently the underlying cause of compliance problems. Management refers to a senior-level manager who has responsibility for overseeing regulated activities.

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

• Completeness and accuracy of records and all information provided to the NRC (10 CFR 30.9);
  
  
• Knowledge about the contents of the application;
  
  
• Applying for a registration certificate amendment if the information provided in the application or contained in the certificate is modified or changed. Registration certificate holders must comply with the information in the registration certificate until the certificate is amended; and,
  
  
• Committing adequate resources (including space, equipment, personnel, time, and, if needed, contractors) to ensure that the registration certificate holder meets its regulatory requirements. The registration certificate holder is required to manufacture or distribute the product in accordance with:
  
  
• the statements and representations contained in the application for safety review and registration;
  
  
• the provisions of the registration certificate; and,
  
  
• NRC regulations.

4 Applicable Regulations

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The following Parts of 10 CFR Chapter I contain regulations applicable to sealed source and device evaluations:

• 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 Investigation"
  
  
• 10 CFR Part 20, "Standards for Protection against Radiation"
  
  
• 10 CFR Part 21, "Reporting of Defects and Noncompliance"
  
  
• 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material"
  
  
• 10 CFR Part 31, "General Domestic Licenses for Byproduct Material"
  
  
• 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material"
  
  
• 10 CFR Part 34, "Licenses for Radiography and Radiation Safety Requirements for Radiographic Operations"
  
  
• 10 CFR Part 35, "Medical Use of Byproduct Material"
  
  
• 10 CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators"
  
  
• 10 CFR Part 39, "Licenses and Radiation Safety Requirements for Well Logging"
  
  
• 10 CFR Part 40, "Domestic Licensing of Source Material"
  
  
• 10 CFR Part 70, "Domestic Licensing of Special Nuclear Material"
  
  
• 10 CFR Part 71, "Packaging and Transportation of Radioactive Material"
  
  
• 10 CFR Part 170, "Fees for Facilities, Materials, Import and Export Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended"
  
  
• 10 CFR Part 171, "Annual Fees for Reactor 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"

The regulations embodied in 10 CFR 30.32(g) and 32.210 codify the current and long-standing practice whereby vendors of sealed sources of radioactive material and devices containing sealed sources submit radiation safety information necessary to perform an independent, technical safety evaluation, and to obtain registration of radiation safety information on certain sealed sources and devices. The practice has been used by the United States Atomic Energy Agency/NRC since the 1950's and by the Agreement States starting in 1962.

The specific provisions in 10 CFR 30.32(g) require a license applicant to either make reference to a registered sealed source or device or provide the information necessary to perform a safety evaluation of the sealed source or device. Section 32.210 outlines the NRC safety evaluation and registration criteria and clarifies the regulatory responsibility of registration certificate holders of products for which the NRC evaluates and registers radiation safety information.

Current regulations only require that products used under a specific license issued in accordance with 10 CFR Part 30 be registered with the Commission. However, if registration of a product design is deemed necessary by NRC, the applicant needs to provide the information contained in 10 CFR 32.210 and the application will be evaluated in the same manner as all registration applications.

The products listed in Sections 4.1 through 4.5 are used by persons exempt from licensing requirements or used in accordance with a general license and NRC has determined that registration of the product design is necessary. However, in addition to the general registration criteria in 10 CFR 32.210, the regulations require that the products meet certain specific requirements. These specific requirements are listed in the appropriate section (Sections 4.1 through 4.5) and need to be addressed during the product evaluation.

Some specific-licensed products are required, by regulation, to meet certain specific requirements in addition to the general registration criteria provided in 10 CFR 32.210. The specific requirements for these products are listed in Sections 4.6 through 4.9 and need to be addressed during the product evaluation.

4.1 Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 for use by Persons Exempt from Licensing Requirements

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Under 10 CFR 30.19, persons are exempted from licensing requirements if the products are initially transferred in accordance with a license issued pursuant to 10 CFR 32.22. Therefore, the requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

Figure 4.1 Watches. Watches are products distributed to persons exempt from licensing under 10 CFR 30.19.

Figure 4.1 Aiming Sights. Aiming sights are products distributed to persons exempt from licensing under 10 CFR 30.19.

Figure 4.2a Smoke and Chemical Agent Detectors. Smoke and chemical agent detectors are products distributed to persons exempt from licensing under 10 CFR 30.20.

Figure 4.2b Smoke and Chemical Agent Detectors. Smoke and chemical agent detectors are products distributed to persons exempt from licensing under 10 CFR 30.20.

4.2 Gas and Aerosol Detectors Containing Byproduct Material for use by Persons Exempt from Licensing Requirements

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Under 10 CFR 30.20, persons are exempted from licensing requirements if the products are initially transferred in accordance with a license issued pursuant to 10 CFR 32.26. Therefore, the requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

4.3 Devices Used Under the General License in 10 CFR 31.5

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Under 10 CFR 31.5, persons may use certain devices in accordance with a general license provided the devices were manufactured or initially transferred in accordance with a license issued pursuant to 10 CFR 32.51. The devices used under the general license include devices designed for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere. The requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

Figure 4.3a 10 CFR 31.5 General License. Gas chromatographs devices are products used under 10 CFR 31.5 general license.

Figure 4.3b 10 CFR 31.5 General License. Density gauge devices are products used under 10 CFR 31.5 general license.

Figure 4.3c 10 CFR 31.5 General License. Static elimination devices are products used under 10 CFR 31.5 general license.

4.4 Luminous Safety Devices Used in Aircraft Under 10 CFR 31.7

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Under 10 CFR 31.7, persons may use luminous safety devices containing tritium or promethium-147 in accordance with a general license provided the devices were manufactured or initially transferred in accordance with a license issued pursuant to 10 CFR 32.53. Therefore, the requirements for product evaluation are imposed on the person licensed to manufacture or initially transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation, are listed below:

Figure 4.4a 10 CFR 31.7 General License. Safety devices, such as exit signs, containing tritium or promethium-147 and used in aircraft may be used under 10 CFR 31.7 general license.

Figure 4.4b 10 CFR 31.7 General License. Safety devices, such as exit signs, containing tritium or promethium-147 and used in aircraft may be used under 10 CFR 31.7 general license.

4.5 Ice Detection Devices Containing Strontium-90

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Under 10 CFR 31.10, persons may use ice detection devices containing strontium-90 in accordance with a general license provided the devices were manufactured or initially transferred in accordance with a license issued pursuant to 10 CFR 32.61. Therefore, the requirements for product evaluation are imposed on the person licensed to transfer the product. Specific requirements, imposed on the product design, that must be addressed during the product evaluation are listed below:

4.6 Radiography Equipment

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Persons specific licensed to perform industrial radiographic operations are only authorized to use equipment that meets the requirements of 10 CFR Part 34. The vendor or custom user of the equipment may demonstrate that the equipment meets these requirements as part of the evaluation and registration of the equipment. Therefore, during an evaluation of radiography equipment, the items listed below must be addressed:

Figure 4.5 Radiography Equipment. Radiography equipment, such as the equipment shown above, must meet the requirements of 10 CFR Part 34.

4.7 Well-Logging Equipment

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Persons specifically licensed to perform well-logging operations are only authorized to use equipment that meets the requirements of 10 CFR Part 39, Subpart C⁽⁴⁾. One such requirement is that the licensed material be as insoluble and nondispersible as practicable. The vendor or custom user of the equipment may demonstrate that the equipment meets the requirements as part of the evaluation and registration of the equipment. Therefore, during an evaluation of well-logging equipment, the items listed below must be addressed:

Figure 4.6 Well-Logging Operations. Sealed sources used in well-logging operations must meet the requirements of 10 CFR Part 39.

4.8 Irradiators

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Persons specifically licensed to use sealed sources in irradiators are only authorized to use sealed sources that meet the requirements of 10 CFR 36.21. One such requirement is that the licensed material be as insoluble and nondispersible as practicable if used in a wet-source-storage or wet-source-change irradiator. The vendor or custom user of the sealed sources may demonstrate that the sealed sources meet the requirements as part of the evaluation and registration of the sealed source. Therefore, during an evaluation of irradiator sources, the items listed below must be addressed:

Figure 4.7a Irradiators. NRC evaluates (a) category I (self-shielded) irradiators used in category IV (Panoramic, wet source storage) irradiators.

Figure 4.7b Irradiators. NRC evaluates (b) sealed sources used in category IV (Panoramic, wet source storage) irradiators.

4.9 Sealed Sources and Devices for Medical Use

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In accordance with 10 CFR 35.49, only sealed sources and devices that are manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to 10 CFR 32.74 may be used for medical uses. The vendor of the sealed sources may demonstrate that the sealed source meets the requirements as part of the evaluation and registration of the sealed source or device. Therefore, during an evaluation of medical sealed sources or devices, the items listed below must be addressed:

One exception to the above requirement is teletherapy sources. Specifically, teletherapy sources do not need to meet the requirements of 10 CFR 32.74. However, 10 CFR 35.49(b) indicates that they do need to be manufactured and distributed in accordance with a license issued pursuant to 10 CFR Part 30.

5 General Policies and Procedures

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5.1 Sealed Source and Device Designs that do not Require Evaluation by IMNS

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10 CFR 30.32(g) applies to all sealed sources and devices used by NRC specific licensees and requires evaluation of the product by NRC. However, the possession and use of certain products does not require the evaluation and registration of the product by IMNS. Specifically, evaluation and licensing of the following products should be handled as indicated below by the license reviewer:

5.1.1 Calibration and Reference Standards

Calibration and reference sources may be licensed without evaluation review by IMNS if the sources do not exceed the following:

• For beta and/or gamma emitting material - 3.7 MBq (100 microcuries) or ten times the quantity specified in Section 30.71, Schedule B, 10 CFR 30, whichever is greater.
• For alpha emitting material - 0.37 MBq (10 microcuries).

The above values were chosen because they represent minimal hazard to public health and safety. To license these sources, license reviewers need to identify the isotope in Item 6 of the materials license, use the statement "calibration or reference sources" in Item 7, and state the maximum quantity for each source in Item 8. Both possession and distribution to specific licensees may be authorized.

Figure 5.1 Calibration and Reference Sources. Calibration and reference sources may not need evaluation and registration by IMNS.

5.1.2 Products used in Research and Development or by Broad Scope Licensees

Sealed sources or devices containing sealed sources that are intended only for use under research and development or broad scope licenses need not be evaluated by IMNS if the licensing reviewer has made a determination that:

• for unregistered sources, or registered sealed sources not possessed and used in accordance with the registration, - the licensee is qualified by sufficient training and experience and has sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unsealed form.
• for registered sealed sources contained in unregistered devices - the licensee is qualified by sufficient training and experience and has sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form.

If a research and development or broad scope licensee wishes to transfer a sealed source or device to another specific licensee, then the recipient must meet the criteria listed above or the sealed source or device must be registered in accordance with 10 CFR 32.210 prior to transfer.

License reviewers should utilize the following standard license condition for those recipients of the registered sealed source contained in unregistered devices:

"The licensee shall use only sealed sources for which a sealed source registration certificate has been issued by the U. S. Nuclear Regulatory Commission pursuant to 10 CFR 32.210(e) or an Agreement State. Possession and use of the sealed sources used must adhere to the conditions and limitations of the registration certificate."

5.1.3 Custom Sealed Sources or Devices

Sealed sources or devices containing sealed sources built to the unique specifications of a given user (custom) need not be sent to IMNS for evaluation if: (a) they contain less than 7.4 GBq (200 millicuries) of radioactive material or less than 740 GBq (20 curies) of tritium, and (b) the licensing reviewer has made a determination that the applicant is qualified by training and experience and has adequate facilities and equipment to safely use and handle the requested quantity of radioactive material in unsealed form. Thus, the applicant would not have to rely on the intrinsic safety of the sealed source or device to demonstrate compliance with 10 CFR 30.33. Custom sealed source and devices which contain an activity greater than that listed above must be submitted to IMNS for evaluation and registration.

To license these custom sealed sources and/or devices, license reviewers need to identify the isotope in Item 6 of the material license, use the statement "custom source" (for unregistered sources) or "sealed source" (for registered sealed sources) including a unique identifier (e.g., drawing or model number), if possible, in Item 7, and state the maximum quantity of radionuclide per source or device in Item 8. In Item 9 (authorized use) license reviewers need to describe, as clearly as possible, the actual use of the custom source or device. Examples: "For use in a Model A analyzer custom built for the licensee by ABC Company in Notown" or "Custom source for use in XYZ Model 100 gauge."

The authorization to use sources or devices described above, that have not been evaluated and registered by IMNS, apply to only to the custom user of the product.

5.2 Custom Users

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A user of a product that is manufactured in accordance with the unique specifications of, and for use by, a single applicant is considered a custom user. Custom users are specifically identified on the first page of registration certificates. The request for the safety evaluation and registration of the product may be made by the custom user or vendor. Regardless of the applicant, the custom user is required to meet all commitments made in the application and registration certificate. Typically, no more than two different NRC or Agreement State licensees may be custom users of, and may register, the same product. However, a custom user may acquire and/or use more than one product.

5.3 As Low as is Reasonably Achievable

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The Commission's requirements to establish programs, procedures, and engineering controls for achieving doses that are as-low-as-is-reasonably-achievable (ALARA) are included in 10 CFR 20.1101. Regulatory Guide 8.10, "Operating Philosophy for Maintaining Occupational Radiation Exposures as Low as Is Reasonably Achievable," explains the NRC's position on this subject. Although these requirements apply to possession and use of radioactive material, applicants should consider the ALARA philosophy when designing and constructing sealed sources or devices to avoid unnecessary exposures during installation, maintenance, repair, and use of the sealed source or device. Regulatory Guide 8.10 may be useful to applicants for establishing and following an ALARA philosophy during the design of a sealed source or device.

5.4 Naturally Occurring or Accelerator-Produced Radioactive Material

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Agreement and Non-Agreement States issue registration certificates for sealed sources or devices containing Naturally occurring or Accelerator-produced Radioactive Material (NARM). Copies of these registration certificates are provided to IMNS by the States. IMNS does not perform a review of these certificates, but does incorporate these certificates into the national registry. Copies are forwarded to the NRC regions, all Agreement States, and appropriate Federal and international agencies as a service to the States. This practice replaces the United States Food and Drug Administration (FDA) "Radioactive Materials Reference Manual." Questions concerning NARM certificates should be directed to OSP, the State, or FDA.

As a general rule, the NRC does not accept applications for radiation safety evaluation and registration of sealed sources or devices that contain NARM. Exceptions to this general rule include sealed sources or devices that contain material that can be reactor or accelerator produced (e.g., cadmium-109), or sealed sources or devices that contain NARM commingled with byproduct material, in either the same or separate encapsulations (e.g., moisture density gauges containing radium-226 and cesium-137).

5.5 Foreign Vendors

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Foreign vendors present a unique situation for the NRC in that the NRC has no jurisdiction over foreign entities. The NRC has historically followed the regulation of 10 CFR Part 110 since a foreign vendor is required to establish an address in the United States to which the NRC can correspond and serve papers as necessary to accomplish its mission. In addition, the NRC inspects the United States distributor of the product and may occasionally audit foreign vendors to determine if the products distributed are in accordance with the statements made in support of the registration certificates.

Figure 5.2 Map of the World. Foreign vendors are required to establish an address in the United States to which the NRC can correspond and serve papers as necessary to accomplish its mission.

5.6 Use of International or Foreign Standards

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In some cases, an applicant may wish to test a product in accordance with an international or foreign standard. In order for the NRC to find this acceptable, the applicant must first demonstrate and the reviewer confirm that the standard meets or exceeds any specific regulatory requirements (e.g., compliance with American National Standards Institute (ANSI) N432-1980 for radiography equipment). The applicant and reviewer must each review the requirements and acceptance criteria of the standard based on the normal and likely accident conditions associated with use, handling, storage, and transport of the product to determine if the standard is acceptable. The foreign or international standard may be compared with an applicable United States standard in determining the acceptance of the standard. This may include professional judgement on the parts of the applicant and reviewer.

If a foreign standard is used, the applicant must submit copies of both the original and English translation of the standard.

5.7 FDA-NRC Memorandum of Understanding

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The FDA and the NRC signed a Memorandum of Understanding (MOU)⁽⁵⁾ to coordinate existing FDA and NRC regulatory programs for medical devices, drugs, and biological products that make use of byproduct, source, or special nuclear materials. The principal statute under which the FDA regulates devices is the Federal Food and Drug and Cosmetic Act, as amended by the Safe Medical Devices Amendments of 1976, the Safe Medical Devices Act of 1990, and the Medical Devices Act of 1992.

Under the MOU, the agencies agree to promptly inform each other whenever they receive a report or otherwise become aware of any potential public health problems involving products of mutual regulatory concern. Further, the agencies will share information to the extent practicable. For IMNS, this includes information used by the NRC for product evaluations and approvals, and any incidents involving product failures. The FDA must be notified in writing when the NRC begins an evaluation of a medical product, whether it is for a new product or for an amendment to an existing product. The notification should include the company, product model number, and the scope of the request. NRC policy precludes the approval of a medical sealed source or device unless the applicant has submitted a copy of the pre-marketing approval [510(k)] issued by FDA. If the pre-marketing approval is not submitted with the application, the applicant will be instructed to contact the FDA and obtain the appropriate approval.

Applicants needing information on FDA requirements may contact:

5.8 Computer Software

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NRC safety evaluations concentrate only on those systems that control fundamental safety processes such as checking an interlock, source or shielding position, and the functionality of position indicators. Software applications that deal with process controls are not part of the product evaluation. The reviewer will determine that if such systems fail (e.g., a power failure), the sealed source or shielding would return to, or remain in, the fully shielded position. Medical applications involving computer software and patient planning systems are, in general, within FDA jurisdiction and FDA is responsible for any necessary review of the software.

Figure 5.3 Computer Software. Safety evaluations concentrate only on those systems that control fundamental safety processes such as checking an interlock, source or shielding position, and the functionality of position indicators.

Applicants should note that some computer systems and software programs, including embedded microprocessors, currently in use, and some systems and programs being distributed, may experience problems as a result of the turn of the new century. Applicants should evaluate the effects of the problems on the normal operation and the operation of the safety features of their equipment.

5.9 Registration Certificate Revocation

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If it is determined that a sealed source or device evaluated by the NRC may pose an undue hazard when used in accordance with the conditions of the registration certificate and corrective actions cannot be implemented or agreed upon between the registration certificate holder and the NRC, the NRC may modify or remove the registration certificate from the national registry and may issue orders modifying licenses to all persons licensed by the NRC to use the sealed source or device. IMNS will also notify OSP so that the Agreement States are made aware of the NRC actions concerning the sealed source or device.

5.10 Incidents

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Incidents involving products evaluated and registered by the NRC are assessed to determine whether the integrity or adequacy of the product was compromised. The assessment involves a re-evaluation of the product to determine its integrity and adequacy, taking into account the causes of the incident. If it is determined that a generic product fault exists, the registration certificate holder will be notified and appropriate actions, affecting both products currently in use and newly manufactured products, will be taken. In addition, the NRC will re-evaluate similar products to ensure they are not susceptible to the same type of faults.

Usually, incidents caused by abnormal or unauthorized use of the product would be considered licensing issues and would not require a re-evaluation of the product.

Some information concerning incidents involving products evaluated by the NRC is kept on file by IMNS for use in performing future evaluations of the products involved and products similar to those involved. However, the Office of Analysis and Evaluation of Operational Data is the NRC Office responsible for compiling, tracking, and analyzing incidents and reports.

5.11 Proprietary Information

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Registration certificates and information contained in the background files for the registration certificates, such as applications, may be made available to the public. Persons may request access to this information in accordance with 10 CFR 9.23.

Proprietary information (i.e., information not to be disclosed to the public) should not be included in an application unless it is the only means to adequately describe the radiation safety properties of the product. If an application contains information marked as "proprietary," "confidential," "restricted," or "is the express property of Company X," the reviewer needs to determine whether the information is necessary to perform the safety evaluation. If the information is not necessary, it should be returned to the applicant.

If the information is necessary, the reviewer needs to ensure that the applicant has submitted a formal request, in accordance with 10 CFR 2.790, for withholding the information. The reviewer needs to evaluate the applicant's request for withholding against the requirements in 10 CFR 2.790 (Appendix B includes a checklist for requests for withholding information from public disclosure). If the request is denied, in whole or in part, the reviewer needs to give the applicant the option of withdrawing the information or application. If the applicant decides not to withdraw the information or application, the reviewer needs to notify the applicant in writing that the request for withholding has been denied and that the reviewer will disregard any references concerning the proprietary status of the information.

Any part of the application that the reviewer has determined should be withheld from public disclosure should be handled in accordance with Management Directive 12.6, "NRC Sensitive Unclassified Information Security Program" and the applicant should be notified in writing that the NRC plans to honor the request. However, the notification needs to inform the applicant that the NRC may have cause to review the determination in the future, for example, if the scope of a Freedom of Information Act request includes the information. In all review situations, if the NRC needs additional information from the applicant or makes a determination adverse to the initial determination, the applicant will be notified in advance of any public disclosure.

5.12 Transportation

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This document does not cover detailed requirements for the transportation of devices and sealed sources. The NRC's transportation requirements are contained in 10 CFR Part 71, "Packaging and Transportation of Radioactive Material." 10 CFR Part 71 establishes:

• procedures and standards for NRC approval of packaging and shipping procedures for fissile material and for a quantity of licensed material in excess of a "Type A quantity" (i.e., exceeding A₁ or A₂ as defined in 10 CFR 71.4); and
• requirements for quality assurance, packaging, preparation for shipment, and transportation of licensed material.

Although an application for radiation safety evaluation of a sealed source or device as discussed in this document is not expected to include a detailed description of packaging and transportation procedures to demonstrate compliance with 10 CFR Part 71, the applicant is expected to be familiar with the way those requirements apply to the sealed source or device and the action needed to ensure that transportation of the device is performed in accordance with applicable requirements.

Any vendor who has questions about the requirements for transportation may contact the appropriate NRC region or NRC's Transportation Safety and Inspection Branch, Spent Fuel Project Office, at (301) 415-8502 to obtain assistance.

Figure 5.4 Packaging and Transportation. Registration certificate holders must meet all NRC and DOT requirements for packaging and transporting sealed sources and devices.

Although IMNS does not evaluate packaging or transportation requirements during sealed source or device evaluations, IMNS does evaluate the effects the packaging or transportation has on normal use and operation of the product as part of the evaluation. Specifically, IMNS evaluates the effects of normal conditions experienced during transport (e.g., extreme temperatures, vibration) on the sealed source or device. Applicants should consider these effects during the design of the products and packaging for transport.

6 How to File

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No special form is required for applications for sealed source or device evaluations. However, to facilitate the review process, applicants for a sealed source or device evaluation are encouraged to do the following:

General/Format:

• Be sure to review the applicable regulations and use the most recent guidance, including this document, in preparing an application.
• Submit all documents, including all drawings if practicable, printed, on standard 8-1/2 inch x 11 inch paper. If submission of larger documents is necessary, they should be folded to 8-1/2 inch x 11 inch.
• All pages in an application should be numbered consecutively. If revisions are necessary after an application has been submitted, revised or replacement pages should be submitted and should show the date of revision or revision number. Supplemental pages submitted for insertion should be indicated alphanumerically (e.g., 12a, 12b, etc.).
• Submit an original, signed application and one additional copy. Retain a copy of the your registration application for future reference.
• Applicants may include a copy of their submittal on 3.5 inch disk in WordPerfect format.

Content:

• Complete the "Summary Data" section of Appendix C, "Application and Review Checklist."
• Attach the balance of the application to the "Summary Data" information. The order of the information in the application should correspond to the appropriate sub-section in Section 10.
• Use the "Checklist" included in Appendix C as a guide to determine whether all necessary information has been provided.
• The application should also include a drawing(s), no larger than about 4 inch x 6 inch, that may be included in the registration certificate, and that provide an overall representation of the product and its safety features.
• When drawings, operating manuals, descriptive sales literature, or similar documents are submitted as part of an application, they should be identified clearly as being part of the application. This might be done by marking the materials individually and listing them on a cover sheet for the application or listing them as enclosures to the letter that transmits the application.
• Avoid submitting proprietary information unless it is absolutely necessary.
• The application should include a clear, concise presentation of the information necessary for the evaluation, avoiding ambiguous and conflicting statements and wordy descriptions that do not contribute to a technical review.
• Terms included in the application should be used as they are defined in NRC regulations and national consensus standards, as applicable. All abbreviations and acronyms should be defined.

Engineering Drawings:

• All drawings should have a drawing number, revision number, company name, title, scale, and date. References to parts or other drawings should be clearly indicated.
• If drawings have been reduced or enlarged, this should be clearly indicated.
• All drawings should include one or several isometric projection diagrams showing components pertinent to radiation safety such as shielding material, shielding thickness, on-off mechanism, on-off indicator, label location, assembly methods, source mounting and security, and dimensions, tolerances, and materials of construction.
• Engineering drawings, must be in English. To facilitate preparing an application on a product manufactured outside the United States, the applicant may elect to write or otherwise affix the English translation directly on an engineering drawing.

It may be advantageous to submit a product (without radioactive material) or a part of a product with an application. For example, a vendor of radiography equipment may elect to submit a "pigtail" connector (used to join the source assembly to the drive cable) as a means of clarifying the related engineering drawings and operating instructions. Large pieces of equipment should not be submitted because of handling and storage limitations at the NRC offices.

All license applications will be available for review by the general public in the NRC's public document room. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. See Section 5.10 of this NUREG for additional details.

Applications may be scanned or put through an optical character reader to convert them to electronic format. To assist with the conversion of the application to electronic media, 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, Helvetica, 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).

7 Where to File

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Applicants located in states or territories subject to NRC jurisdiction wishing to register a sealed source or device may file an application with the NRC by submitting the application to:

Please note that the above address is different from that of the appropriate NRC region to which persons would apply for authority to possess and use radioactive material under a manufacturing and distribution license.

The above address cannot accept mail requiring the receiver's signature (e.g., express mail). Mail requiring the receiver's signature should be sent to:

Applicants in locations subject to Agreement State jurisdiction wishing to apply for safety evaluation and registration of a sealed source or device should file the application with the appropriate Agreement State agency, not the NRC. See Section 2 for additional information concerning filing applications with Agreement States.

8 Registration Fees

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Each application for which a fee is specified, including applications for new registration certificates and registration certificate amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. For applicants for sealed source and device evaluations, the appropriate fee categories are 9A, 9B, 9C, and 9D. The registration certificate or amendment will not be issued until full payment of the fee has been received.⁽⁶⁾ Once the technical review process 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 registration certificate holders 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 registration certificate holders that may qualify as "small entities."

Direct all questions about NRC's fees to the Office of the Controller (OC) at the 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.

9 Document Flow

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9.1 Application Receipt and Assignment to a Reviewer

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Requests for safety evaluations of sealed sources or devices usually are submitted by the applicant directly to IMNS. However, applications may be submitted to other NRC sections or Offices (e.g., as part of a licensing action) and forwarded to IMNS as a technical assistance request. For example, the NRC regions and other sections within IMNS may receive requests as part of a license request, or OC may receive a request to make a registration certificate inactive. The processing of the application is the same in all cases.

NRC staff submitting technical assistance requests for sealed source and device evaluations to IMNS should use NRC Form 567, "Request for a Sealed Source Device Evaluation." The requester needs to follow the instruction block at the top of the form for specific detail on how and what to submit.

When IMNS receives an application, an acceptance review is performed to determine whether there is sufficient information to initiate a review. If there is sufficient information to initiate a review, the applicant is sent a letter acknowledging receipt of the application; if not, the entire package is returned to the applicant for resubmission of a complete application.

Applications are logged into the sealed source and device action tracking system where they await assignment to a reviewer. Each action is assigned a unique tracking number. Assignment to a reviewer is determined on a first-in basis. An application may be assigned a higher priority based on the dire need for the product to protect public health and safety, the product providing a currently unavailable benefit to society, or commercial hardship that is likely to be experienced by the applicant if the evaluation process is delayed. Requests for higher priority should include adequate justification.

While an application is awaiting assignment to a reviewer, a copy of the cover letter to the application and the NRC Form 567 is sent to the OC for verification that the appropriate application fees have been received. OC will return NRC Form 567 to IMNS indicating whether the appropriate fees have been collected. IMNS may start an evaluation of a sealed source or device before fees are collected, however, a final approval of the product will not be issued until the application fees are paid in full.

9.2 Reviewer's Responsibilities

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The reviewer is responsible for performing the technical evaluation of the product, ensuring the product meets all applicable standards and regulations, corresponding with the applicant to obtain additional information, if necessary, generating the registration certificate, and ensuring the application is reviewed and signed by two persons having signature authority. In addition, the reviewer needs to identify any complex policy issues and bring them to management's attention.

In some cases, the adequacy of an element of the product design may not be readily evident. As a result, it may be necessary for the reviewer to exercise professional judgment regarding the adequacy and safety of the product design. Such judgment should be discussed with the applicant and included in a note from the reviewer to the registration file. A copy of the note to the registration file should be provided to the applicant.

Once the evaluation and registration are complete, the registration certificate, including cover letter to the applicant and technical assistance request response, if applicable, and all information used in support of the evaluation, are forwarded to the registration assistant for distribution and filing.

9.3 Distribution of Completed Certificates

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The registration assistant processes distribution of all registration certificates issued by the NRC and the Agreement States.

After the registration certificate is completed and the package is forwarded to the registration assistant, all correspondence between the NRC and the applicant is sent to the Document Control Desk (DCD). Copies of Agreement State certificates also are forwarded to DCD. DCD ensures that the information is included in Nuclear Documents System and the Public Document Room.

The registration assistant distributes copies of all registration certificates to the NRC regions, all Agreement States, other Federal agencies, and international agencies. The NRC File Center ensures that original NRC registration certificates are maintained in the registration folders and that a master set of copies of the certificates are maintained and easily accessible to IMNS.

9.4 Inclusion in the Sealed Source and Device Computerized Registration System

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Once issued, the registration certificate is added to the sealed source and device computerized registration system. The information included on the first page of the registration certificate is included in the system and certificate information can be located by searching on any item that is included in the first page of the certificate (see Section 12.2).

10 Contents of the Application and the Review Process

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Applicants requesting safety evaluations and persons who evaluate the adequacy of products must address the following items to verify sufficient information is submitted and determine whether the design of the product is adequate for its proposed uses.

Applicants are encouraged to follow the instructions in Section 6 and use Appendix C as a guideline when submitting applications. Applicants should complete the "Summary Data" section of the appendix and use the "Checklist" to ensure that they have addressed all items listed in this section. The balance of the application should be attached to the copy of the appendix. Reviewers should use the checklist to verify the applicant has addressed all items listed in this section.

It should be noted that certain regulations include specific requirements applicable to evaluation and registration of products. Section 4 lists these regulations and each regulation also is listed at the end of the applicable topic of this section. The regulatory requirements take precedence over the general guidance provided in this section. Applicants must ensure, and reviewers verify, that all regulatory requirements are met.

10.1 Summary Information

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Manufacturer and Distributor

Applications must include the complete names and addresses of both the manufacturer and distributor of the product. The same person may be both the manufacturer and distributor. However, if different, the distributor should be the person applying for the evaluation. The distributor will be responsible for meeting the requirements associated with the registration, whether the information is supplied by the distributor or by the manufacturer on behalf of the distributor.

Custom User

Applications must indicate whether the product is intended for use by a custom user. The customer user needs to be identified by name and complete address. See Section 5.2 for additional information concerning custom users.

A product specifically designed and constructed to the order of a single licensee may be considered a custom product. Since there is a single user of the product, the NRC can appropriately consider specific departures from accepted standards from the point of view of compensating qualifications or conditions of use for the particular licensee. Usually, these departures occur in the areas of prototype testing and quality control (QC) procedures.

Other Companies Involved

The application must include the name, complete mailing address, and function of all other companies involved in the manufacture and distribution of the product.

Model Number, Sealed Source or Device Type, and Principal Use Code

The application must clearly state the model number designation for the product. This model number will be listed on the registration certificate for the product and may be listed on licenses of persons applying to use the product. The model number is used by the NRC and Agreement States to uniquely identify the product.

An applicant may request to have a model listed as a series. In order to have the model listed as a series, there should be similarities in the design and construction of the products. Applicants should provide detailed engineering drawings of each basic source or device series containing overall dimensions, maximum and minimum dimensions, tolerances, materials of construction, and differences between models in the series.

The application needs to identify the sealed source or device type as used by the industry (e.g., level gauge, radiography device, self-shielded irradiator, teletherapy unit, etc.) and the principal use code that most accurately describes the product. A listing of principal use codes is included in Appendix E. This information assists applicants and reviewers in determining the applicable regulations, codes, and standards that affect registration of the product.

The application also needs to identify whether the device is intended to be used under a specific license, general license, either a specific or general license, or by persons exempt from licensing requirements. If applicable, the applicant and reviewer need to determine which general license or exemption applies for possession and use of the product. Information needed to make this determination must be provided by the applicant. This is discussed further under Section 10.2, which discusses the conditions of use of the product.

Radionuclides Used in the Product

The applicant must identify all radionuclides that will be used in the product and include the maximum requested activity for each, including loading tolerance. The application must also include the form of the byproduct material, including contaminates or impurities, if applicable. It is not necessary for applicants to provide information on contaminates or impurities that have little effect on the radiation levels from the sealed source or on how the sealed source will react under extreme environmental conditions.

For evaluations of devices, the applicant must identify whether the associated sealed source is currently registered. If so, the model number designation and the manufacturer or distributor of the sealed source, as listed on the registration certificate for the sealed source, must be identified.

If the sealed source is not currently registered, the sealed source must be registered separately or as part of the device. In either case, the applicant must submit sufficient information to register the sealed source and the reviewer must perform a complete evaluation of the sealed source. If the sealed source is registered as part of the device, the registration certificate for the device should note that the sealed source is not registered separately, is registered as part of the device, and is only approved for use in the device.

Leak Test Frequency

The applicant must provide the maximum time interval between leak tests to be performed on the product. Typically, products are required to be leak tested at intervals not to exceed 6 months. Leak test procedures must be capable of detecting the presence of 185 Bq (0.005 microcurie) of removable contamination.

Products containing only krypton-85, hydrogen-3 (tritium), radioactive gas, isotopes with half-lives of 30 days or less, beta- or gamma-emitting material of no more than 3.7 MBq (100 microcuries), or alpha-emitting material of no more than 370 kBq (10 microcuries) are exempt from periodic leak testing requirements. However, prior to initial distribution of the product, a leak test should be performed.

Devices may be approved with leak test intervals greater than 6 months if sufficient information is submitted to justify such a request. Current policy requires, for specific- or general-licensed products, the applicant to supply the information listed in 10 CFR 32.51(b) or 32.74(b)(1) for evaluation if a longer leak test interval is requested.

The following regulations should be referenced for additional information concerning leak testing: