RIS 2004-18, Expiration Date for 10 CFR Part 71 Quality Assurance Program Plan Approvals.
| ML042160293 | |
| Person / Time | |
|---|---|
| Issue date: | 12/01/2004 |
| From: | Brach E NRC/NMSS/SFPO |
| To: | |
| Karmis M, NMSS/SFPO 415-8553 | |
| References | |
| RIS-04-018 | |
| Download: ML042160293 (5) | |
ML042160293UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, DC 20555 December 1, 2004NRC REGULATORY ISSUE SUMMARY 2004-18 EXPIRATION DATE FOR 10 CFR PART 71 QUALITY ASSURANCEPROGRAM APPROVALS
ADDRESSEES
All holders of U.S. Nuclear Regulatory Commission (NRC) - approved 10 CFR Part 71 QualityAssurance Programs (QAPs).
INTENT
NRC is issuing this regulatory issue summary (RIS) to notify affected parties of a change to therenewal period for 10 CFR Part 71 QAPs. The intent is to reduce the unnecessary regulatory burden of some administrative actions. No specific action nor written response is required.
BACKGROUND
Currently, after review and approval of the applicant's 10 CFR Part 71 QAP, an expiration dateof 5 years is entered on NRC Form 311, "Quality Assurance Program Approval Form ForRadioactive Material Packages." The use of an expiration date requires the QAP to be renewed in accordance with 10 CFR 71.38, "Renewal of a certificate of compliance or quality assurance program approval," should the holder of an NRC-approved 10 CFR Part 71 QAPelect to continue regulated activities pursuant to 10 CFR Part 71.
SUMMARY OF ISSUE
S
10 CFR 71.38 does not specify a QAP duration. The NRC staff notes that the 5-year QAPapproval period was established to provide an opportunity for NRC staff to periodically reviewQAPs and to maintain periodic contact with the QAP holders. The 5-year renewal period also facilitated NRC record keeping in terms of points of contact, package fabrication, use activities,and other administrative activities. In the case where a previously approved QAP, from an Appendix B, 10 CFR Part 50 program,is used to satisfy the requirements of 10 CFR Part 71, the NRC staff notes that a 5-year QAPapproval period is also entered in Block 3 of the QAP Approval For Radioactive Material Packages form - NRC Form 311. The NRC staff notes that the need to maintain an opportunity for NRC staff review of QAPs andperiodic contact with the holders of NRC-approved 10 CFR Part 71 QAPs, by way of the 5-yearrenewal period, is less important now than in the past. Staff contact now occurs more frequently with the annual billing process required to maintain a QAP approval pursuant to 10CFR Part 171. At this time NRC is made aware of any changes to points of contact,organizational changes, and termination of QAPs. In addition, the NRC inspection programprovides reasonable assurance that QAP requirements and commitments are effectively implemented. For these reasons the use of a 5-year expiration date is no longer justified and burdens QAP holders with arbitrary renewal dates that require resubmittal of their QAPs, in accordance with 10 CFR 71.38, even when there have been no changes nor reductions in commitment to the QAPs.Conclusion: Effective immediately, NRC will be entering an expiration date on Form
311 of10 years in order to reduce unnecessary regulatory burden. In the interest of efficiency, existing QAP's will not be revised -- that is, upon the next regular renewal or amendment, NRCwill issue a 10-year expiration. Further, the regulations of 10 CFR Part 71 continue to providereasonable assurance that QAP holders will adequately maintain and implement their NRC-approved QAPs. Further, staff will assess whether a rulemaking change is appropriate tocodify the effective term of a QAP approval, or whether any expiration date for the QAP is needed. The NRC staff notes that before implementation of any change to its NRC-approved10 CFR Part 71 QAP, the licensee or certificate holder is required to submit any and all QAP
changes to NRC for review and approval.
BACKFIT DISCUSSION
This RIS does not require any action that would implicate a backfit; therefore, the staff did notperform a backfit analysis.
FEDERAL REGISTER NOTIFICATION
A notice of opportunity for public comment on this RIS was not published in the Federal Register because the RIS is informational and clarifies the guidance on the QAPapproval expiration date.
PAPERWORK REDUCTION ACT STATEMENT
This Regulatory Issue Summary modifies information collection requirements that are subject tothe Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) by extending the term for Quality Assurance Program renewals. These information collections were approved by the Office of Management and Budget, approval number 3150-0008.The burden reduction to the public for these mandatory information collections is estimated toresult in an average reduction of 15 responses annually at 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments regarding this burden estimate or any other aspect of these information collections, including suggestions for reducing the burden, to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to INFOCOLLECTS@NRC.GOV; and to the Desk Officer, Office of Informationand Regulatory Affairs, NEOB-10202, (3150-0008), Office of Management and Budget,Washington, DC 20503. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request forinformation or an information collection requirement unless the requesting document displays a currently valid OMB control number.This RIS requires no specific action nor written response. If you have any questions about thissummary, please contact the technical contact listed below./RA/E. William Brach, Director Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards
Technical Contact:
G. Michael Karmis, NMSS 301-415-8553 E-mail: mgk@nrc.govAttachment: List of Recently Issued NRC Regulatory Issue Summaries
PAPERWORK REDUCTION ACT STATEMENT
This Regulatory Issue Summary modifies information collection requirements that are subject tothe Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) by extending the term for Quality Assurance Program renewals. These information collections were approved by the Office of Management and Budget, approval number 3150-0008.The burden reduction to the public for these mandatory information collections is estimated toresult in an average reduction of 15 responses annually at 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments regarding this burden estimate or any other aspect of these information collections, including suggestions for reducing the burden, to the Records and FOIA/Privacy Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail to INFOCOLLECTS@NRC.GOV; and to the Desk Officer, Office of Informationand Regulatory Affairs, NEOB-10202, (3150-0008), Office of Management and Budget,Washington, DC 20503. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request forinformation or an information collection requirement unless the requesting document displays a currently valid OMB control number.This RIS requires no specific action nor written response. If you have any questions about thissummary, please contact the technical contact listed below./RA/E. William Brach, Director Spent Fuel Project Office Office of Nuclear Material Safety and Safeguards
Technical Contact:
G. Michael Karmis, NMSS 301-415-8553 E-mail: mgk@nrc.govAttachment: List of Recently Issued NRC Regulatory Issue SummariesDISTRIBUTION
- NRC File CenterNMSS r/fSFPO r/f ML042160293 *see previous concurrenceOFC:SFPOSFPOSFPONRR/DIPMNRROGCNAME:GKarmis*EKraus*RLewis*TQuay*CPetrone*NJensen*DATE: 11/ 29/0405/25/04 5/28 /04 6/ 02/046 /02/04 7/ 15/04OFC:OCFOSFPOSFPONAME:JFunches* emailLCamper*EWBrachDATE:10/ 25/04 06/08/04 12/01 /04 / /04 / /04 / /04C = COVERE = COVER & ENCLOSUREN = NO COPYOFFICIAL RECORD COPY
______________________________________________________________________________________OL = Operating License CP = Construction PermitAttachment LIST OF RECENTLY ISSUEDNRC REGULATORY ISSUE SUMMARIES
_____________________________________________________________________________________Regulatory Issue Date of Summary No. Subject IssuanceIssued to
_____________________________________________________________________________________2004-17Revised Decay-In-StorageProvisions for the Storage of Radioactive Waste Containing Byproduct Material11/23/2004All licensees regulated under10 CFR Parts 30, 32, 33, and 50.2004-16Use of Later Editions andAddenda to ASME Code Section XI For Repair/Replacement Activities10/19/2004All holders of operating licensesfor nuclear power reactors, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.2004-15Emergency Preparedness Issues:Post 9/1110/18/2004All holders of operating licensesfor nuclear power reactors, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.2004-14Focusing Resources in the Officeof Nuclear Reactor Regulation as a Result of Review of Security Plan Changes09/20/2004All holders of operating licensesfor nuclear power reactors, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.Note:NRC generic communications may be received in electronic format shortly after they areissued by subscribing to the NRC listserver as follows:To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the followingcommand in the message portion:subscribe gc-nrr firstname lastname