ML073340477
| ML073340477 | |
| Person / Time | |
|---|---|
| Issue date: | 12/31/2007 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| Orr M P/RES/301-415-6373 | |
| Shared Package | |
| ML073340466 | List: |
| References | |
| DG-6005 RG-6.004, Rev 3 | |
| Download: ML073340477 (5) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION December 2007 OFFICE OF NUCLEAR REGULATORY RESEARCH Division 6 DRAFT REGULATORY GUIDE
Contact:
Mark Orr (301) 415-6373 DRAFT REGULATORY GUIDE DG-6005 (Proposed Revision 3 of Regulatory Guide 6.4, dated August 1980)
VERIFICATION OF CONTAINMENT PROPERTIES OF SEALED RADIOACTIVE SOURCES A. INTRODUCTION This guide directs the reader to the type of information acceptable to the U.S. Nuclear Regulatory Commission (NRC) to evaluate and verify the containment properties of sealed radioactive sources. The NRC licenses the manufacture and distribution of devices containing radioactive byproduct material under Title 10, Part 32, Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material, of the Code of Federal Regulations (10 CFR Part 32). The regulations require, in part, that each application for a specific license to distribute devices containing byproduct material include information on procedures for prototype tests and the results of such tests to demonstrate that the source or device will maintain its integrity during the most severe conditions that are likely to be encountered under normal or accidental conditions of handling, storage, use, and disposal of the sealed radioactive source.
The provisions of 10 CFR Part 32 address the specific licensing requirements for containment of byproduct material in sealed radioactive sources by product type. The requirements for licensing major product categories and specific exempt products are delineated in:
10 CFR 32.14, Certain Items Containing Byproduct Material; Requirements for License to Apply or Initially Transfer, 10 CFR 32.15, Same: Quality Assurance, Prohibition of Transfer, and Labeling, 10 CFR 32.16, Certain Items Containing Byproduct Material: Records and Reports of Transfer, This regulatory guide is being issued in draft form to involve the public in the early stages of the development of a regulatory position in this area. It has not received final staff review or approval and does not represent an official NRC final staff position.
Public comments are being solicited on this draft guide (including any implementation schedule) and its associated regulatory analysis or value/impact statement. Comments should be accompanied by appropriate supporting data. Written comments may be submitted to the Rulemaking, Directives, and Editing Branch, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; e-mailed to NRCREP@nrc.gov; submitted through the NRCs interactive rulemaking Web page at http://www.nrc.gov; faxed to (301) 415-5144; or hand delivered to the Rulemaking, Directives, and Editing Branch, Office of Administration, U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, MD 20852, between 7:30 a.m. and 4:15 p.m. on Federal workdays. Copies of comments received may be examined at the NRCs Public Document Room, 11555 Rockville Pike, Rockville, MD. Comments will be most helpful if received by April 18, 2008.
Electronic copies of this draft regulatory guide are available through the NRCs interactive rulemaking Web page (see above);
the NRCs public Web site under Draft Regulatory Guides in the Regulatory Guides document collection of the NRCs Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections/; and the NRC=s Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML073340477.
DG-6005, Page 2 10 CFR 32.18, Manufacture, Distribution and Transfer of Exempt Quantities of Byproduct Material: Requirements for License, 10 CFR 32.19, Same: Conditions of Licenses, 10 CFR 32.20, Same: Records and Material Transfer Reports, 10 CFR 32.21, Radioactive Drug: Manufacture, Preparation, or Transfer for Commercial Distribution of Capsules containing Carbon-14 Urea Each for In Vivo Diagnostic for Humans to Persons Exempt From Licensing; Requirements for a License, 10 CFR 32.21a, Same: Conditions for License, 10 CFR 32.22, Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 Requirements for License to manufacture, process, produce, or Initially Transfer, 10 CFR 32.23, Same: Safety Criteria, 10 CFR 32.25, Conditions of Licenses Issued Under § 32.22: Quality Control, Labeling, and Reports of Transfer, 10 CFR 32.26, Gas and Aerosol Detectors Containing Byproduct Material: Requirements for License to Manufacture, Process, Produce, or Initially Transfer, 10 CFR 32.27, Same: Safety Criteria, 10 CFR 32.28, Same: Same: Table of Organ Doses, 10 CFR 32.29, Conditions of Licenses Issued Under § 32.26: Quality Control, Labeling, and Reports of Transfer, 10 CFR 32.74, Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use, and 10 CFR 32.210, Registration of Product Information, (for specifically licensed items).
Additionally, vendors under other material licenses may be required to submit similar qualification testing information when requesting approvals for standardized source or device designs.
Retention of radioactive material within a device or source is dependent on the containment properties of the source.
Radiation safety programs for the use of byproduct material in 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.
This regulatory guide endorses the methods and procedures for evaluation and verification of the containment properties of sealed radioactive sources contained in the current revision of NUREG-1556, Volume 3, Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration, as a process that has been found acceptable to the NRC staff for meeting the regulatory requirements. Since the publication of Revision 2 of Regulatory Guide 6.4 in August 1980, the NRC has revised the requirements for byproduct material containments in 10 CFR Part 32 to implement a risk-informed, performance-based approach to regulation. This revised approach is incorporated into NUREG-1556.
The NRC issues regulatory guides to describe to the public methods that the staff considers acceptable for use in implementing specific parts of the agencys regulations, to explain techniques that the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Guidance in this regulatory guide represents one means acceptable to the staff of complying with NRC regulations and is not intended to be the only means of satisfying requirements for a license.
Regulatory guides are not substitutes for regulations and compliance with them is not required.
DG-6005, Page 3 This regulatory guide contains information collections that are covered by the requirements of 10 CFR Part 32 and approved by the Office of Management and Budget (OMB) under OMB control number 3150-0001. The NRC may neither conduct nor sponsor, and a person is not required to respond to, an information collection request or requirement unless the requesting document displays a currently valid OMB control number.
B. DISCUSSION As part of its redesign of the materials license program, the NRC consolidated and updated numerous guidance documents for material licenses into the multivolume NUREG-1556. Various volumes in the NUREG-1556 series provide current, program-specific guidance on testing, licensing, decommissioning, and terminating materials licenses.
Volume 3 of NUREG-1556 describes how to file a request with the NRC for radiation safety evaluation and registration of sealed sources and devices containing byproduct material to the NRC. It also lists the applicable regulations and industry standards as well as the policies affecting evaluation and registration. Volume 3 contains administrative procedures to be followed, information on how to perform the evaluation and how to prepare a registration certificate, and the responsibilities of the registration certificate holder. In addition, it is designed to provide the reviewer of such requests with guidance, information, and materials necessary to perform a complete and thorough evaluation of the submittal.
NUREG-1556 is available electronically through the Public Electronic Reading Room on the NRCs public Web site, at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556. Copies are also available for inspection or copying for a fee from the NRCs Public Document Room (PDR) at 11555 Rockville Pike, Rockville, MD. The mailing address for the PDR is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; email PDR@nrc.gov. In addition, copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402-9328, telephone (202) 512-1800; or from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, Virginia 22161, online at http://www.ntis.gov, by telephone at (800) 553-NTIS (6847) or (703) 605-6000, or by fax to (703) 605-6900.
C. REGULATORY POSITION This regulatory guide endorses the methods and procedures for evaluation and verification of the containment properties of sealed radioactive sources described in the current revision of Volume 3 of NUREG-1556 as a process that has been found acceptable to the NRC for meeting the regulatory requirements.
D. IMPLEMENTATION The purpose of this section is to provide information to applicants and licensees regarding the NRCs plans for using this draft regulatory guide. No imposition or backfit is intended or approved in connection with its issuance.
The NRC has issued this draft guide to encourage public participation in its development. The NRC will consider all public comments received in development of the final guidance document. Except in those cases in which an applicant or licensee proposes or has previously established an acceptable alternative method for complying with specified portions of the NRCs regulations, the methods described in the active guide will be used in evaluating compliance with the regulations as discussed in this guide for license applications, license amendment applications, and exemption requests.
DG-6005, Page 4 REGULATORY ANALYSIS
- 1.
Statement of the Problem The NRC published Revision 2 of Regulatory Guide 6.4 in August 1980 to provide licensees with agency-approved guidance for complying with the then current versions of 10 CFR 32.51. The NRCs implementation of a risk-informed, performance-based approach, combined with multiple updates and revisions to the regulations, makes the current regulatory guide outdated.
- 2.
Objective As part of its redesign of the materials licensing process, the NRC consolidated and updated numerous materials license guidance documents into a single comprehensive repository. This comprehensive repository is the multivolume NUREG-1556. Each volume of NUREG-1556 contains program-specific guidance for various materials licenses and licensee activities. The NRC developed and issued the multiple volumes of NUREG-1556 to provide both the licensee and NRC staff with current guidance.
The objective of this action is to provide clear and up-to-date information to support consolidated guidance about materials licenses in general and methods and procedures for evaluation and verification of the containment properties of sealed radioactive sources in particular.
- 3.
Alternative Approaches To meet this objective, the staff considered the following alternative approaches:
Do not revise Regulatory Guide 6.4.
Withdraw Regulatory Guide 6.4.
Revise Regulatory Guide 6.4 to match or replace Volume 3 of NUREG-1556.
Revise Regulatory Guide 6.4 to endorse Volume 3 of NUREG-1556.
3.1 Alternative 1: Do Not Revise Regulatory Guide 6.4 Under this alternative, the NRC would not revise this document, and the original version of this regulatory guide would continue to be used. However, this alternative would leave conflicting guidance in place and could cause unnecessary confusion. This alternative is considered the baseline or no action alternative and, as such, involves no value/impact considerations.
3.2 Alternative 2: Withdraw Regulatory Guide 6.4 Withdrawing this regulatory guide would eliminate the problem of NUREG-1556 and this regulatory guide containing duplicate and occasionally contradictory information. However, this action would leave a void in the regulatory guide system and provide no quick method for interested parties to identify the method(s) the NRC finds acceptable for decommissioning and terminating a materials license.
Although this alternative would cost relatively little, it may impede the publics accessibility to the most current information.
DG-6005, Page 5 3.3 Alternative 3: Revise Regulatory Guide 6.4 to Match or Replace Vol. 3 of NUREG-1556 NUREG-1556 is a multivolume document first published in May 1997 to provide consolidated guidance about materials licenses in accordance with the most current regulatory requirements.
Regulatory Guide 6.4 contains specific guidance about only one of the many areas covered in Volume 3 of NUREG-1556. Revising Regulatory Guide 6.4 to match the existing NUREG-1556 would create duplicate sources of information and would require future staff resources to ensure that the separate documents continue to contain duplicate information. Revising this regulatory guide to replace Volume 3 of NUREG-1556 would involve a large expenditure of labor without a noticeable enhancement in performance or efficiency for the NRC or its licensees. This alternative is considered to be an unnecessary use of staff resources.
3.4 Alternative 4: Revise Regulatory Guide 6.4 to Endorse Vol. 3 of NUREG-1556 The August 1980 version of the regulatory guide contains a process that has been superseded by the NRC staffs implementation of a risk-informed, performance-based approach for satisfying the requirements of 10 CFR Part 32. Failure to revise the regulatory guide to reflect this would result in conflicting guidance documents and possible confusion to interested parties. Therefore, the staff has chosen to revise the regulatory guide to direct any interested parties to the most current guidance for classifying containment properties of sealed radioactive sources provided in Volume 3 of NUREG-1556.
- 4.
Conclusion Based on this regulatory analysis, the staff recommends that the NRC revise Regulatory Guide 6.4 to endorse the methods and procedures for evaluation and verification of the containment properties of sealed radioactive sources described in the current revision of Volume 3 of NUREG-1556 as a process that has been found acceptable to the NRC for meeting the regulatory requirements. The staff has concluded that the proposed action will reduce unnecessary burden on both the NRC and its licensees and will result in an improved and more uniform process. Moreover, the staff sees no adverse effects associated with issuing this regulatory guide.