ML080500059
| ML080500059 | |
| Person / Time | |
|---|---|
| Issue date: | 04/17/2008 |
| From: | Office of Nuclear Regulatory Research |
| To: | |
| Orr M/RES/415-6373 | |
| Shared Package | |
| ML080500050 | List: |
| References | |
| DG-0019 | |
| Download: ML080500059 (5) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION April 2008 OFFICE OF NUCLEAR REGULATORY RESEARCH Division 10 DRAFT REGULATORY GUIDE
Contact:
M. Orr (301) 415-6373 DRAFT REGULATORY GUIDE DG-0019 (Proposed Revision 2 of Regulatory Guide 10.9, dated December 1988)
GUIDE FOR THE PREPARATION OF APPLICATIONS FOR THE USE OF SELF-CONTAINED DRY SOURCE-STORAGE GAMMA IRRADIATORS A. INTRODUCTION This regulatory guide directs the reader to the type of information acceptable to the U.S. Nuclear Regulatory Commission (NRC) staff for review of an application for the use of a self-contained dry source-storage gamma irradiator. Title 10, Part 36, Licenses and Radiation Safety Requirements for Irradiators, (Ref. 1) of the Code of Federal Regulations (10 CFR Part 36) contains the licensing, design, and radiation safety requirements for irradiators. In addition, licensees and applicants may be subject to portions of the requirements in 10 CFR Part 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, (Ref. 2) and 10 CFR Part 20, Standards for Protection Against Radiation. (Ref. 3)
This regulatory guide endorses the methods and procedures describing how to apply for a license to use a self-contained dry source-storage gamma irradiator contained in the current revision of NUREG-1556, Volume 5, Consolidated Guidance about Material Licenses: Program-Specific Guidance about Self-Shielded Irradiator Licenses, (Ref. 4) as a process that the NRC staff finds acceptable for meeting the regulatory requirements.
Volume 5 of NUREG-1556 addresses the issues that an applicant must respond to when preparing a license application on NRC Form 313, Application for Materials License. The NUREG also includes guidance on amending a license and terminating operations.
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 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; emailed 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 Rulemaking, Directives, and Editing Branch, Office of Administration, US NRC, 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 June 30, 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 NRCs Agencywide Documents Access and Management System (ADAMS) at http://www.nrc.gov/reading-rm/adams.html, under Accession No. ML080500059.
DG-0019, Page 2 the staff uses in evaluating specific problems or postulated accidents, and to provide guidance to applicants. Regulatory guides are not substitutes for regulations and compliance with them is not required.
This regulatory guide contains information collection requirements covered by 10 CFR Parts 20, 30, and 36 and NRC Form 313 and that the Office of Management and Budget (OMB) approved under OMB control numbers 3150-0014, 3150-0017, 3150-0158, and 3150-0044, respectively. 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 licensing 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 5 of NUREG-1556 provides program-specific guidance on applying for a license to use a self-contained dry source-storage gamma irradiator, and identifies the information needed to complete NRC Form 313. Additionally, the NUREG provides an overview of the types of irradiator licenses issued by the NRC, the commitments and responsibilities that a licensee must undertake, applicable regulations, the process for filing a license application, and the contents of applications for different types of irradiators. In particular, Volume 5 of NUREG-1556 gives an item-by-item description of the information to be provided by an applicant. Because of the wide variety in the types of irradiators, the NUREG contains indicators to alert applicants for particular types of irradiators to material that pertains to those types. The NRC is placing added emphasis on conducting its regulatory activities in a risk-informed and performance-based manner. This approach is intended to be less prescriptive and to allow licensees the flexibility to implement the agencys regulations in a manner that is more specific to their needs yet still meets the regulatory requirements. By supplying examples, the NRC seeks to provide information to meet the needs of applicants for licensure without being prescriptive. Guidance in NUREG-1556 represents one means of complying with NRC regulations and is not intended to be the only means of satisfying the regulatory requirements.
NUREG-1556 is available electronically through the 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; and 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), at 5285 Port Royal Road, Springfield, VA 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.
DG-0019, Page 3 C. REGULATORY POSITION This regulatory guide endorses the guidance for applying for a license to use a self-contained dry source-storage gamma irradiator or revising an existing license for a self-contained source-storage gamma irradiator requests described in the current revision of NUREG-1556, Volume 5, as a process that the NRC has found to be acceptable 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. The NRC does not intend or approve any imposition or backfit 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. In some cases, applicants or licensees may propose an alternative or use a previously established acceptable alternative method for complying with specified portions of the NRCs regulations. Otherwise, the methods described in this guide will be used in evaluating compliance with the applicable regulations for license applications, license amendment applications, and amendment requests.
REGULATORY ANALYSIS
- 1.
Statement of the Problem The NRC published Revision 1 of Regulatory Guide 10.9, Guide for the Preparation of Applications for Licensees for the Use of Self-Contained Dry Source-Storage Gamma Irradiators, in December 1988 to provide licensees with agency-approved guidance for complying with the then-current version of 10 CFR Part 36. 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 for the preparation of an application for a license to use a self-contained dry source-storage gamma irradiator.
- 3.
Alternative Approaches The NRC staff considered the following alternative approaches:
Do not revise Regulatory Guide 10.9.
Withdraw Regulatory Guide 10.9.
DG-0019, Page 4 Revise Regulatory Guide 10.9 to match or replace Volume 5 of NUREG-1556.
Revise Regulatory Guide 10.9 to endorse Volume 5 of NUREG-1556.
3.1 Alternative 1: Do Not Revise Regulatory Guide 10.9 Under this alternative, the NRC would not revise this guidance, and applicants would continue to use the original version of this regulatory guide. 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 10.9 Withdrawing this regulatory guide would eliminate the problem of the inclusion of duplicate and occasionally contradictory information in NUREG-1556 and this guide. However, this action would leave a void in the regulatory guide system and provide no quick means for interested parties to identify the requirements necessary to prepare an application for a license to use a self-contained dry source-storage gamma irradiator that the NRC finds acceptable. Although this alternative would cost relatively little, it could impede the publics access to the most current information.
3.3 Alternative 3: Revise Regulatory Guide 10.9 to Match or Replace Volume 5 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 10.9 contains specific guidance about only one of the many areas covered in Volume 5 of NUREG-1556. Revising the regulatory guide to match the information in Volume 5 of NUREG-1556 would create duplicate sources of information and would require ongoing staff resources to ensure that the separate documents continued to contain duplicate information. Revising this regulatory guide to replace Volume 5 of NUREG-1556 would require substantial expansion of the current guide and 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 10.9 to Endorse Volume 5 of NUREG-1556 The December 1988 version of the regulatory guide no longer represents a method acceptable to the NRC for satisfying the requirements of 10 CFR Part 36. Failure to revise the regulatory guide will result in conflicting guidance documents and the possible confusion of interested parties. Therefore, the staff has chosen to revise the regulatory guide to direct any interested parties to the most current guidance provided in Volume 5 of NUREG-1556.
- 4.
Conclusion Based on this regulatory analysis, the staff recommends that the NRC revise Regulatory Guide 10.9 to endorse the guidance on applying for a license to use a self-contained dry source-storage gamma irradiator described in the current revision of NUREG-1556, Volume 5. The staff concludes 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.
DG-0019, Page 5 REFERENCES
- 1.
10 CFR 36, Licenses and Radiation Safety Requirements for Irradiators, U.S. Nuclear Regulatory Commission, Washington, DC.1
- 2.
10 CFR 30, Rules of General Applicability to Domestic Licensing of Byproduct Material, U.S.
Nuclear Regulatory Commission, Washington, DC.1
- 3.
10 CFR 20, Standards for Protection Against Radiation, U.S. Nuclear Regulatory Commission, Washington, DC.1
- 4.
NUREG 1556, Volume 5, Consolidated Guidance about Material Licenses: Program-Specific Guidance about Self-Shielded Irradiator Licenses, U.S. Nuclear Regulatory Commission, Washington, DC.2 1
All NRC regulations listed herein are available electronically through the Electronic Reading Room on the NRCs public Web site, at http://www.nrc.gov/reading-rm/doc-collections/. 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 is USNRC PDR, Washington, DC 20555; telephone (301) 415-4737 or (800) 397-4209; fax (301) 415-3548; and e-mail PDR@nrc.gov.
2 NUREG-1556 is available electronically through the 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; and 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), at 5285 Port Royal Road, Springfield, VA 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.