ML20007G579
| ML20007G579 | |
| Person / Time | |
|---|---|
| Issue date: | 05/20/1997 |
| From: | NRC (Affiliation Not Assigned) |
| To: | NRC (Affiliation Not Assigned) |
| References | |
| NUDOCS 9705280421 | |
| Download: ML20007G579 (10) | |
Text
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OFFICE OF NUCLEAR REACTOR REGULA TION Office Letter Transmittal TO:
All NRR Employees
SUBJECT:
NRR OFFICE LETTER NO. 1300, REVISION 2, " PROCEDURES FOR i
HANDLING 10 CFR PART 21 AND 10 CFR 50.55(e) NOTIFICATIONS OF DEVIATIONS, DEFECTS, AND FAILURES TO COMPLY ASSOCIATED WITH SUBSTANTIAL SAFETY HAZARDS AT NUCLEAR POWER REACTORS AND THEIP VENDORS" i
PURPOSE:
This office letter describes processing by the Office of Nuclear Reactor Regulation (NRR) of certain notifications 4
required by regulations. The subject regulations are in 10 CFR Part 21 and 10 CFR 50.55(e).
Such notifications typically describe failures to comply with the Atomic Energy Act of 1954, as amended, or applicable rules or regulations relating to substantial safety hazards, defects of basic
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1 components that could cause substantial safety hazards, or deviations determined to be defects. This office letter also identifies areas of responsibility for processing these reports within NRR and interactions of NRR with other offices.
Right-hand marginal bars indicate revised text. This revision supersedes NRR Office Letter No.1300, Revision 1, dated August 28, 1991.
l DIVISION OF i
ORIGIN:
Division of Reactor Program Management t
CONTACT:
Alfred E. Chaffee, 415-1168 g) g DATE APPROVED:
May 20, 1997 AVAILABILITf:
Roberta Ingram, 415-1219
{0M M (l.)L M._,.
LTIL 280080 9;r_for 9705280421 970520 CF SUBJ ID&R-SNRR OFL CF
NRR OFFICE LETTER NO.1300, REVISION 2 PROCEDURES FOR HANDLING 10 CFR PART 21 AND TO CFR 50.55(e) NOTIFICA TIONS OF DEVIA TIONS, DEFECTS, AND FAILURES TO COMPLY ASSOCIATED WITH SUBSTANTIAL SAFETY HAZARDS A T NUCLEAR POWER REACTORS AND THEIR VENDORS DEFINITIONS 10 CFR Part 21 Notifications The purpose of Part 21 is to ensure that the NRC receives prompt notification of possible substantial safety hazards in facilities or activities licensed by the NRC. The NRR staff reviews notifications related to nuclear power reactors to determine the need for regulatory action (such as issuance of an information notice or a bulletin.)
Part 21, " Reporting of Defects and Noncompliance," implements the requirements of Section 206 of the Energy Reorganization Act of 1974, as amended.
Part 21 requires firms and organizations building, operating, or owning NRC-licensed facilities or conducting NRC-licensed activities and firms and organizations supplying safety-related components and safety-related design, testing, inspection, and consulting services to evaluate identified deviations or to inform the licensee or purchaser of the deviation in order that the licensee or purchaser may perform an evaluation to determine whether the identified deviation could constitute a substantial safety hazard.
Section 21.21 requires that directors and responsible officers of entities subject to Part 21 be notified when a determination is made that an identified deviation could constitute a substantial safety hazard (defined as a defect), or a i
failure to comply is discovered. These individuals, in turn, are required to notify the NRC that the existence of a defect or a failure to comply has been identified.
Section 21.51 requires each entity subject to Part 21 to maintain such records as may be required to ensure compliance with the regulation.
Each entity subject to Part 21 is also required to prepare records in connection with the design, manufacture, fabrication, placement, erection, installation, modification, inspection, or testing of any facility or basic component supplied for any licensed facility. Additionally,10 CFR 21.41 requires entities subject to Part 21 to permit the NRC staff to inspect their records, premises, activities, and basic components to ensure compliance with Part 21.
10 CFR 50.55(e) Notifications The purpose of 10 CFR 50.55(e) is to ensure that the HRC receives prompt notification of design and construction deficiencies that, if they remain uncorrected, could adversely affect the operational safety of the nuclear power plant at any time throughout its expected lifetime. The NRC staff reviews these notifications to determine the need for regulatory action.
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l BACKGROUlO Part 21 and 10 CFR 50.55(e) reports form part of the tRC system for obtaining l
information relevant to nuclear safety and acting on the information in the appropriate regulatory manner. Part 21 reports (but not 10 CFR 50.55(e) reports) may be classified into sets related to nuclear reactors, for which NRR is responsible, and to nonreactor uses of radioactive materials, for which the Office of Nuclear Material Safety and Safeguards is responsible.
l This office letter addresses only NRR processing of Part 21 and 10 CFR 50.55(e) reports related to nuclear reactors.
In addition to Part 21 and 10 CFR 50.55(e) notifications, NRR receives and screens other reports required by the regulations of 10 CFR 50.72 (quick notifications to the NRC Operations Center),10 CFR 50.73 (licensee event reports [LERs]), and information generated by NRC regional offices in the form of w *ning tA ephone conferences, written morning reports, and prelimina;y notifications of occurrences. All this event information is screened by NRR, with the Events Assessment and Generic Communications Branch (PECB) in the Division of Reactor Program Management (DRPM) taking a centralized lead. Thus, the Part 21 and 10 CFR 50.55(e) reports are treated on the same basis as other event information. That is, the NRC responses to Part 21 and 10 CFR 50.55(e) reports are often the same responses to other reports from other channels. They are screened end, as needed, assigned for review.
If appropriate, a generic communication is issued.
In addition, inspections and investigations may be initiated.
To facilitate screening of these reports, the NRC Document Control Desk electronically scans those incoming documents identified as submitted under Part 21 or 10 CFR 50.55(e) and makes these reports electronically available to PECB. PECB then makes these reports available in text-searchable format to all NRC staff and ensures that vendor Part 21 notifications are placed in the Public Document Room.
NOTIFICATIONS In this letter, the terms " notification," " report," and " source document" are used interchangeably, as are the terms " vendor" and " supplier."
ThepurposeofPart21and10CFR50.55(e)istoensurethattheNRCreceivesl 1
prompt notification of possible substantial safety hazards in facilities or activities licensed by the NRC. The NRR staff reviews notifications related to nuclear power reactors to determine the ne.ed for regulatory action (such as issuance of a generic communication or performance of an inspection).
Part 21 Notifications Part 21 requ;res individuals, firms, organizations, or other entities l
building,. operating, or owning NRC-licensed facilities, conducting NRC-licensed activities, and supplying safety-related components and design, testing, inspection, and consulting services to (1) evaluate identified deviations or (2) inform the licensee or purchaser so that it may evaluate an
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identified deviation to determine whether the deviation could constitute a substantial safety hazard.
10 CFR 50.55(e) Notifications 9
The purpose of 10 CFR 50.55(e) is to ensure that the NRC receives prompt notificaticn of design and construction deficiencies that, if they remain uncorrected, could adversely affect the operational safety of the nuclear i
power plant during its expected lifetime. The NRC staff reviews these l
notifications to determine the need for regulatory action.
RESPONSIBILITIES AND AUTHORITIES Part 21 Notifications General The NRC Part 21 management process as related to nuclear power reactors is intended to --
1 (1) ensure that the NRC staff adequately reviews Part 21 notifications to assess safety significance, determine generic applicability, and determine the need for regulatory response, such as issuance of a generic communication or performance of an inspection; (2) ensure (by inspections performed on an audit basis) that licensees and vendors have established and implemented effective Part 21 programs to identify, evaluate, and report deviations, defects, or failures to comply; and (3) ensure (by inspections performed on an audit basis) that licensees have established and implemented an effective process to assess, on a plant-specific basis, the safety impact of operational experience i
information (including Part 21 notifications) and to take appropriate torrective actions.
Oral Part 21 notifications should be made to the NRC Operations Center.
However, if a person orally notifies an NRC staff member of a Part 21 repor+,
the staff member should accept it and remind the person that Part 21 requit.;
that a written report also be filed. The staff member should then promptly forward any written notifications received to the Document Control Desk and inform PECB.
Written Part 21 notifications should be sent to the Document Control Desk, l
U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001. The Regulatory Information Distribution System (RIDS) distributes the written notifications.
The NRR focal point for initial assessment of Part 21 notifications related to nuclear reactors is PECB. The focal point for rulemaking activities
~ associated with Part 21 is the Quality Assurance and Maintenance Branch in the Division of Reactor Controls and Human Factors.
The NRC staff wiil process an anonymous written or verbal notification as an allegation and not as a Part 21 report.
NRR Events Assessment and Generic Communications Branch PECB is responsible for ensuring that vendor Part 21 notifications are placed in the Public Document Room.
PECB is responsible for screening Part 21 and 10 CFR 50.55(e) notifications as part of the system described in NRR Office Letter 503, " Procedure for Integrated Identification, Evaluation, Prioritization, Management, and Resolution of Generic Issues." PECB tracks incoming Part 21 source documents and arranges for appropriate NRR review. The PECB tracking objective is to create an auditable trail for each incoming dccument from receipt to closure of the technical issue involved.
PECB recognizes two types of documents previously entered into the Part 21 management process:
(1) documents designated as Part 21 reports and (2) documents reporting deviations, defects, or failures but not specifically designated as Part 21 reports.
The latter documents, generally LERs, were previously labeled potential Part 21 reports by NRC staff, even though the originator of the report did not explicitly cite "Part 21" as the reason for providing the information contained therein.
This practice has been changed so that only those documents that contain an explicit Part 21 designation are processed as Part 21 source documents. Those documents not designated as Part 21 reports are processed normally as discussed in Office Letter 503.
The PECB Part 21 Coordinator has responsibility for identifying Part 21 source documents. Headquarters Operations Officers in the NRC Operations Center and PECB branch secretaries forwLrd Part 21 correspondence to the coordinator. Other NRC staff may transmit potential Part 21 documents to the coordinator. The PEC3 Management Analyst maintains the Events Tracking System (ETS), a computer database used to track all event assignments. The ETS is widely available to NRR and other NRC offices.
The ETS contains electronic text-searchable images of Part 21 reports.
For a particular Part 21 source document, an assigned PECB staff engineer reviews the Part 21 source document for generic safety significance, soliciting assistance from NRR technical branches and briefing the NRC Events Assessment Panel as needed.
If the engineer needs assistance from more than one technical branch to resolve an issue and the technical branches need additional information to characterize the problem, the engineer will serve as an issue manager in obtaining and distributing the information.
In many inst >.nces, PECB determines that licensees have been adequately informed of potentially safety-significant notifications that may be applicable to their facilities. This situation arises when vendors notify both the NRC and their customers of the identified deviation or defect.
Such actions are typically considered sufficient to address the identified defect l
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or failure to comply. However, because PECB may not be aware of pending issues concerning vendors, each applicable PECB assignment will request input from the Vendor Inspection Section of the NRR Special Inspection Branch (PSIB) before closing staff action.
NRR Technical Review Branches When PECB tentatively concludes that there is no immediate safety concern requiring prompt regulatory action, PECB may request, by issuing a technical action control (TAC) number, that other NRR technical branches perform a more detailed review of a Part 21 notification and confirm PECB's initial assessment. The technical branch assigned review responsibility should --
(1) promptly review the Part 21 notification to reassess its safety significance and generic applicability and recommend appropriate regulatory action (such as issuance of a generic communication or an inspection),
(2) obtain,asnecessary,additionalinformationinconjunctionwithPECB,l (3) determine whether any proposed corrective actions described in the Part 21 notification are adequate to address the identified issue for each applicable plant, and (4) determine whether all potentially affected licensees have been identified and have been adequately informed of potentially safety-significant notifications that may apply to their facilities.
Upon completion, the technical branch will provide PECB with an adequate basis for closing staff action on the Part 21 notification. NRR technical review branches need not process Part 21 reports unless specifically requested to do so by PECB.
PECB will document the resolution in the ETS, which is available to all NRR staff.
SDeCial InSDection Branch l
PSIB in the Division of Inspection and Support Programs is considered to be an NRR technical review branch for purposes of these discussions. As such, the responsibilities and remarks previously noted under "NRR Technical Review Branches" apply to PSIB.
In addition, PSIB personnel determine whether vendors' Part 21 programs are in conformance with Part 21 and are sufficient to identify and report defects or failures to comply as part of their routine inspection activities. These inspection activities include vendor Part 21 reported defects and failures to comply, which will have been provided, as noted above, by PECB for use by PSIB in its ongoing branch activities.
As a collateral responsibility, PSIB conducts procurement / vendor interface inspections at licensee facilities. During these inspections, PSIB personnel determine whether licensees are performing adequate plant-specific evaluations of vendor-identified deviations. PSIB will, during these procurement / vendor i
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I interface inspections, also verify licensee imposition of Part 21 requirements in purchase orders.
PSIB will coordinate this activity with the appropriate regional staff.
Reaional Offices NRC resident and region-based inspectors perform inspections, on an audit basis, to ensure that certain licensee programs are in conformance with i
Part 21. These programs are to identify, evaluate, and report defects or failures to comply that are associated with substantial safety hazards.
Inspection Procedure 36100, "10 CFR Part 21 Inspection at Nuclear Power i
Reactors," contains specific inspection guidance.
NRC resident and region-based inspectors perform inspections, on an audit basis, to ensure that licensees have appropriate mechanisms in place to i
address the feedback of operational experience information (such as Part 21 notifications, NRC information notices and bulletins, and Institute of l
Nuclear Power Operations SEE-IN reports) and to take appropriate corrective action (10 CFR 50.65). These inspection activities focus on ensuring the effectiveness of licensees' programs to evaluate operational experience information and, on the basis of the results of their evaluation, to take appropriate corrective action.
Inspection Procedure 90700, " Feedback of P,.2 rational Experience Information at Operating Power Reactors" contains specific inspection guidance.
The regional offices should forward all Part 21 notifications received to PECB. The regional offices need not process Part 21 reports unless specifically requested to do so by NRR. As needed, NRR will request specific regional action through issuance of a temporary instruction.
The ETS is available to NRC regional offices. The ETS contains electronic text-searchable images of Part 21 reports.
PECB will document resolution of all reactor-related Part 21 reports in the ETS.
10 CFR 50.55(e) Notifications General
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The NRC 10 CFR 50.55(e) management process ensures that the NRC is promptly notified of sionificant deficiencies identified at nuclear power plants under construction.
Section 50.55(e) was changed on October 29, 1991 (Federal Reaister, Volume 56, page 36081, July 31,1991).
Initial oral 10 CFR 50.55(e) notifications are now to be made to the NRC Operations Center. However, if a person orally notifies an NRC staff member of a 10 CFR 50.55(e) report, the j
staff member should accept it and remind the person that a written report i
must also be filed. The staff member should then promptly forward any written notifications received to the Document Control Desk and inform DRPM.
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. Written 10 CFR 50.55(e) notifications should be sent to the Document Control Desk, U.S. Nuclear Regulatory Commission, Nashington, D.C. 20555-0001. The RIDS distributes the written notifications.
The NRC staff will process an anonymous written or verbal notification as an allegation and not as a 10 CFR 50.55(e) report.
Holders of construction permits for nuclear power reactors have routinely made reports under both Part 21 and 10 CFR 50.55(e). The rule revisions cited above eliminated this duplication of reporting by having holders of construction permits consolidate such reports under 10 CFR 50.55(e).
Recional Offices i
The regional offices are responsible for reviewing 10 CFR 50.55(e) reports submitted by holders of construction permits in their respective regions.
If the regional office identifies such a report to indicate a potentially generic safety problem, the regional office forwards the report to PECB in accordance with Inspection Manual Chapter 0970, "Potentially Generic Items Identified by Regional Offices."
NRR Events Assessment and Generic Communications Branch l
PECB is responsible fnr reviewing potentially generic 10 CFR 50.55(e) reports submitted by the regional offices in accordance with Inspection Manual Chapter 0970 and for determining the need for regulatory action (such as issuance of a generic communication).
In addition, PECB will inform the originating regional office of the final disposition of the generic reports.
EFFECTIVE DATE This office letter revision is effective immediately.
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8-REFERENCES 1.
Code of Federal Regulations, Title 10, Part 21, " Reporting of Defects and Noncompliance" 2.
NRR Office Letter 503, " Procedure for Integrated Identification, Evaluation, Prioritization, Management, and Resolution of Generic Issues" 3.
Inspection Procedure 36100, "10 CFR Part 21 Inspection at Nuclear Power Reactors" 4.
Inspection Procedure 90700, " Feedback of Operational Experience Information at Operating Power Reactors"
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Inspection Manual Chapter 0970, "Potentially Generic Items Identified by Regional Offices" 4
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L. Callan, EDO I
H. Thompson, DEDR E. Jordan, DEDO P. Norry, DEDM H. Miller, RI L. Reyes, RII l
A. Beach, RIII E. Merschoff, RIV l
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REFERENCES 1.
Code of Federal Regulations, Title 10, Part 21, " Reporting of Defects i
dnd Noncompliance" 2.
NRR Office Letter 503, " Procedure for Integrated Identification, Evaluation, Prioritization, Management, and Resolution of Generic Issues" 3.
Inspection Procedure 36100, "10 CFR Part 21 Inspection at Nuclear Power i
Reactors" 4.
Inspection Procedure 90700, " Feedback of Operational Experience Informatf n at Operating Power Reactors" 5.
Inspection Manual Chapter 0970, "Potentially Generic Items Identified by Regional Offices" J
cc:
L. Callan, EDO H. Thompson, DEDR E. Jordan, DEDO P. Norry, DEDM H. Miller, RI l
L. Reyes, RII l
A. Beach, RIII l
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0FFICIAL RECORD COPY j
A copy of this document was informally provided to a branch chief in each regional office. No comments were received. This document was also reviewed by several NRR divisions: DISP, DSSA, DE, and DRCH. Their comments were appropriately considered and incorporated.
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