ML20022A159

LIC-403, Revision 4 Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR 50.55(e))

ML20022A159
Person / Time
Issue date:	03/06/2020
From:	Mirela Gavrilas NRC/NRR/DRO/IOEB
To:	Office of Nuclear Reactor Regulation
Issa A. 415-5342, NRR/DRO
References
LIC-403, Y020190366
Download: ML20022A159 (10)

Text

OFFICE OF NUCLEAR REACTOR REGULATION LIC-403, Revision 4 Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR 50.55(e))

Volume 400 Events & Generic Communications Approved By:

Mirela Gavrilas Date Approved:

March 6, 2020 Effective Date:

March 9, 2020 Certification Date:

March 9, 2025 Responsible Organization:

DRO Primary Contacts:

Stephen Pannier Alfred Issa Stephen.Pannier@nrc.gov Alfred.Issa@nrc.gov 301-415-4083 301-415-5342 Summary: This revision reflects the reunification of NRR and NRO and makes other necessary updates. This issuance incorporates and rescinds the related NRO instruction NRO-REG-122, Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR 50.55(e)), Revision 3.

Training:

None ADAMS Accession Number:

ML20022A159 TABLE OF CONTENTS

1.

POLICY................................................................................................................................... 2

2.

OBJECTIVES......................................................................................................................... 2

3.

BACKGROUND...................................................................................................................... 2

4.

BASIC REQUIREMENTS....................................................................................................... 2

5.

RESPONSIBILITIES AND AUTHORITIES............................................................................. 3

6.

PERFORMANCE MEASURES............................................................................................... 7

7.

PRIMARY CONTACTS.......................................................................................................... 7

8.

RESPONSIBLE ORGANIZATION.......................................................................................... 7

9.

EFFECTIVE DATE.................................................................................................................. 7

10.

CERTIFICATION DATE.......................................................................................................... 7

11.

REFERENCES........................................................................................................................ 7

ML19155A036 OFFICE NRR/DRO/IOEB NRR/DRO/IOEB/BC NRR/DRO/IQVB NRR/DRO/IRIB NRR/DRO:D NAME AIssa LRegner KKavanagh THipschman MYoung DATE 2/5/2020 2/18/2020 2/18/2020 2/6/2020 2/18/2020 OFFICE NRR/DNRL:D NRR/DANU:D NRR/DEX:D NRR/DSS:D NRR/DRA:D NAME ABradford BSmith EBenner JDonoghue GBowman DATE 2/18/2020 2/19/2020 2/19/2020 2/19/2020 2/19/2020 OFFICE NRR/DORL:D NRR/DRMA NRR:DD NAME GSuber TGorham MGavrilas DATE 2/20/2020 03/04/2020 03/06/2020

NRR Office Instruction NRR-LIC-403, Revision 4 Page 2 of 8

1.

POLICY This office instruction describes the processing of certain regulatory notifications by the Office of Nuclear Reactor Regulation (NRR). The subject regulations are found in Title 10 of the Code of Federal Regulations (10 CFR) Part 21, Reporting of Defects and Noncompliance, and in paragraph (e) of 10 CFR 50.55, Conditions of construction permits, early site permits, combined licenses, and manufacturing licenses. These notifications typically describe failures of basic components to comply with the Atomic Energy Act of 1954, as amended, or with any applicable U.S. Nuclear Regulatory Commission (NRC) rule, regulation, order, or license relating to substantial safety hazards and defects of basic components that could cause substantial safety hazards.

2.

OBJECTIVES The objective of this office instruction is to describe the process by which NRR receives, screens, distributes, and evaluates reports pertaining to defects and noncompliance.

These reports are generally received under 10 CFR Part 21 (Part 21) and 10 CFR 50.55(e) (50.55(e)), but reactor licensees may also report the information under 10 CFR Part 50.72 or Part 50.73. This office instruction also specifies the responsibilities of various NRR organizations and their interactions with other offices in processing these notifications.

3.

BACKGROUND Part 21 ensures that the NRC receives prompt notification of potential defects that could cause a substantial safety hazard in facilities or activities licensed by the NRC. 50.55(e) requires that the NRC receives prompt notification of nuclear power plant design and construction deficiencies that, if left uncorrected, could adversely affect the operational safety of the plant at any time throughout its expected lifetime.

NRR Office Instruction LIC-401, Reactor Operating Experience Program (LIC-401) provides guidance for collecting, screening, evaluating, communicating, and applying Operating Experience (OpE) information in a systematic, timely, and coordinated manner to effectively support the agencys goal of ensuring safety. The definitions and processes provided in LIC-401 are applicable to this office instruction.

This office instruction uses the terms notification, report, and source document interchangeably, as well as the terms vendor and supplier. Unless noted otherwise, this instruction applies to Part 21, 50.55(e), and related 10 CFR 50.72 and 10 CFR 50.73 reports, which are collectively called Subject Reports.

4.

BASIC REQUIREMENTS Subject Reports form part of the NRC system for obtaining and acting on information relevant to nuclear safety in the appropriate regulatory manner. Most Subject Reports are applicable to operating nuclear reactors licensed under 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, or new reactors licensed under 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants.

Subject Reports may also apply to other licensed activities such as nuclear materials, fuel cycle facilities, and nuclear security. This NRR office instruction addresses the

NRR Office Instruction NRR-LIC-403, Revision 4 Page 3 of 8 posting of all Subject Reports on the NRC public Web site, but only provides additional guidance for the review and processing of Subject Reports related to power and nonpower reactors licensed and designed under 10 CFR Part 50 and 10 CFR Part 52.

Staff members from NRR review all applicable Subject Reports to:

(1) screen and evaluate them for potential lessons learned and/or follow up actions in accordance with LIC-401; (2) assess their completeness and identify any areas that may require a request for additional information (RAI) from a vendor, applicant, or licensee; (3) determine the need to issue a generic communication based on their safety significance and scope of the deficiency; and (4) assess the need to inspect vendors, applicants, or licensees to ensure adequate corrective actions are implemented.

If a declaration, statement, or assertion of impropriety or inadequacy associated with NRC-regulated activities is identified or received during the receipt or processing of Subject Reports, the staff is required to follow the applicable agency and NRR guidance on management of allegations (see Management Directive 8.8, Management of Allegations, and NRR Office Instruction OVRST-200, Management of Allegations.)

To facilitate screening of Subject Reports, the NRC Document Control Desk scans them and makes them electronically available to the staff in the Agencywide Documents Access and Management System (ADAMS), using templates that describe uses of the Electronic Regulatory Information Distribution System (e-RIDS) within ADAMS. The NRR Division of Reactor Oversight (DRO) Generic Communication and Operating Experience Branch (IOEB) ensures that these reports are made available to both the staff and the public on the Part 21 Reports page and the accompanying 50.73 Licensee Event Reports page for Subject Reports that are received under those sections of the Code of Federal Regulations. Both of these web pages reside on the NRC external web site.

5.

RESPONSIBILITIES AND AUTHORITIES NRR, Division of Reactor Oversight (DRO)

DRO ensures adequate resources are available for IOEB, the Reactor Inspection Branch (IRIB), and the Quality Assurance, and Vendor Inspection Branch (IQVB) to ensure the objectives of this office instruction are met.

NRR, Division of Operating Reactor Licensing (DORL)

DORL provides resources, as necessary, to facilitate obtaining additional information from licensees that may be necessary to support the evaluation of Subject Reports, and to assist in the review and disposition of requests to withhold proprietary information from public disclosure pursuant to 10 CFR 2.390.

NRR Office Instruction NRR-LIC-403, Revision 4 Page 4 of 8 NRR, Division of New and Renewed Licenses (DNRL)

DNRL provides resources as necessary and in accordance with its project prioritization guidance to facilitate obtaining additional information that may be necessary to support the evaluation of Subject Reports from licensees, Part 52 applicants licensed under the New Reactor Licensing Program, or certificate holders. Additionally, DNRL supports evaluation tasks related to Subject Reports as needed.

NRR, Division of Advanced Reactors and Non-Power Production and Utilization Facilities (DANU)

DANU provides resources, as necessary, to facilitate obtaining additional information that may be necessary to support the evaluation of Subject Reports from licensees, Part 52 or Part 50 applicants licensed under the New Reactor Licensing Program, or certificate holders. Additionally, DANU supports the evaluation tasks related to Subject Reports as needed.

NRR, Division of Engineering and External Hazards (DEX)

DEX provides technical support for the evaluation of Subject Reports as needed.

NRR, Division of Safety Systems (DSS)

DSS provides technical support for the evaluation of Subject Reports as needed.

NRR, Division of Risk Assessment (DRA)

DRA provides technical support for the evaluation of Subject Reports as needed.

NRR/DRO/IOEB IOEB tracks and publishes incoming Subject Reports on the NRC public website.

IOEB staff screens Subject Reports in accordance with NRR Office Instruction LIC-401.

NRR/DRO/IOEB Branch Chief The IOEB branch chief assigns an IOEB staff engineer to perform the duties of the Subject Report Coordinator and will assign backup coordinators as required.

NRR/DRO/IQVB IQVB is responsible for rulemaking and vendor inspection activities associated with the requirements of Part 21 and Section 50.55(e).

NRR Office Instruction NRR-LIC-403, Revision 4 Page 5 of 8 IQVB is an NRR technical review branch for the purposes of this office instruction.

However, IQVB has additional responsibilities for NRR-related Part 21 and 10 CFR 50.55(e) reports that include: (1) contacting a licensee or vendor in order to obtain amplifying information when the extent of condition, generic applicability, or safety significance associated with a Subject Report is not readily apparent or defined, (2) identifying common-cause deficiencies affecting more than one reactor, (3) sponsoring changes to the regulations that increase reactor safety, and (4) conducting vendor inspections to resolve issues when necessary.

IQVB should contact the entity reporting a defect when necessary to obtain additional information related to the safety significance and generic applicability of the defect when:

(1) the Subject Report is originated by a licensee, (2) the Subject Report is submitted by an equipment supplier that does not have the capability to perform an evaluation (10 CFR 21.21(b)), or (3) a licensee event report made under 10 CFR 50.73 meets the reporting requirements of 10 CFR 21.2(c) but the licensee does not provide specific information that would ordinarily be required if the report was submitted as a stand-alone Subject Report (10 CFR 21.21(d)(4)(i) through (viii)). During vendor inspections, IQVB personnel determine whether vendors are performing adequate evaluations of identified deviations and verifying licensee imposition of Part 21 requirements in purchase orders.

IQVB will coordinate this activity with the appropriate regional staff.

NRR Technical Branches NRR technical review branches should refer to LIC-401 for guidance on conducting evaluations and making recommendations. In general, it is the goal of the evaluation to:

(1) determine the impact on current applicants, licensees and licensing actions under review, (2) recommend communication of lessons learned, and (3) determine what, if any, actions or changes to NRC programs or activities are necessary to prevent, detect, and mitigate future occurrences of the postulated or actual condition or event.

Upon completing a requested review, the technical branch will provide the Issue Manager with an adequate basis, with or without recommendations, for closing the staff action on the Subject Report. The Issue Manager ensures that the IOEB documents the resolution of the Subject Report in the RPS-Oversight Reactor Operating Experience (ROE) Part 21 database.

Subject Report Coordinator The Subject Report Coordinator (Coordinator) is a member of the IOEB staff and is the primary contact for this office instruction. The Coordinator performs the following tasks:

(1)

Routinely receives Subject Report correspondence from the NRC Operations Center, the NRC Document Control Desk, and occasionally directly from licensees, applicants, certificate holders, or other NRC staff; (2)

Organizes Subject Reports by assigning each Subject Report a unique identification number and tracking them in the RPS-Oversight ROE Part 21 database;

NRR Office Instruction NRR-LIC-403, Revision 4 Page 6 of 8 (3)

Ensures that the Subject Reports are reviewed for sensitive unclassified non-safeguards information before being made publicly available to stakeholders on the NRC external Web site; (4)

Contacts a licensee or vendor (with support from IQVB and/or other technical branches if necessary) to obtain amplifying information when the extent of condition, generic applicability, or safety significance associated with a Subject Report is not readily apparent or defined; (5)

Adds wording to the Part 21 description on the public Web site to indicate that the defect in a basic component was reported by the licensee under 10 CFR 50.55(e), 50.72, 50.73, or 73.71 (as applicable); and (6)

Provides administrative updates to the RPS-Oversight ROE Part 21 database as required when the Subject Report is processed in accordance with this instruction.

A detailed description for administratively processing Subject Reports is maintained in the IOEB Handbook.

Operating Experience Clearinghouse Team The OpE Clearinghouse Team (Clearinghouse) screens each Subject Report against the screening criteria in LIC-401. In addition to making a screening determination, the Clearinghouse will also decide on the appropriate internal distribution for a Subject Report. The Clearinghouse should consider the following factors when distributing information related to Subject Reports:

(1) when the report is submitted by a supplier of basic components who does not have the capability to perform an evaluation to determine if a defect exists (10 CFR 21.21(b));

(2) when the initial and written notification of the defect is submitted by a licensee and the extent of condition to the rest of the industry cannot be readily determined; (3) when the notification is made via 10 CFR 50.72, 50.73, 73.71 or 50.55(e); and (4) when a 10 CFR 50.55(e) report is made for a significant breakdown in any portion of the quality assurance program that could have produced a defect (10 CFR 50.55(e)(3)(iii)(C)).

Additional information related to generic applicability and safety significance obtained via telephone conversation or electronic message from a licensee or vendor by IQVB and/or IOEB will be used in the screening process.

Subject Reports that meet the LIC-401 Level 2 screening criteria (as determined by the Clearinghouse) are screened in as IFRs. Upon the recommendation of the Coordinator, the Clearinghouse assigns each Level 2 Subject Report to an OpE engineer, designated as the Issue Manager, for evaluation and closure. The Clearinghouse ensures that all Subject Report information is distributed to responsible individuals and subject matter

NRR Office Instruction NRR-LIC-403, Revision 4 Page 7 of 8 experts within the agency, including those in other NRC headquarter offices, the regional offices, and resident inspectors at potentially impacted units. The responsibility for communicating Subject Report information to responsible individuals will be captured in the IOEB Clearinghouse Screening Summary. The OpE Clearinghouse is also responsible for identifying Subject Reports that are included in 10 CFR 50.72, 50.73, or 73.71 reports, and for ensuring that these Subject Reports are tracked, published to the NRC public Web site, and screened in accordance with this procedure.

Issue Manager For Subject Reports that are screened as IFRs, the Issue Manager reviews the information for generic safety significance, soliciting assistance from the appropriate NRR technical branches. Guidance for evaluating and closing out an IFR is contained in LIC-401.

6.

PERFORMANCE MEASURES None

7.

PRIMARY CONTACTS Stephen Pannier 301-415-4083 Stephen.Pannier@nrc.gov Alfred Issa 301-415-5342 Alfred.Issa@nrc.gov

8.

RESPONSIBLE ORGANIZATION DRO

9.

EFFECTIVE DATE March 9, 2020

10.

CERTIFICATION DATE March 9, 2025

11.

REFERENCES

1. U.S. Code of Federal Regulations, Reporting of Defects and Noncompliance, Part 21, Chapter 1, Title 10, Energy. (http://www.nrc.gov/reading-rm/doc-collections/cfr/).

2. U.S. Code of Federal Regulations, Domestic Licensing of Production and Utilization Facilities, Part 50, Chapter I, Title 10, Energy. (http://www.nrc.gov/reading-rm/doc-collections/cfr/).

NRR Office Instruction NRR-LIC-403, Revision 4 Page 8 of 8

3. U.S. Code of Federal Regulations, Licenses, Certifications, and Approvals for Nuclear Power Plants, Part 52, Chapter 1, Title 10, Energy.

(http://www.nrc.gov/reading-rm/doc-collections/cfr/)

4. NRR Office Instruction OVRST-200, Management of Allegations available at https://usnrc.sharepoint.com/teams/NRR-OI-Listing/Lists/OI%20Listing/AllItems.aspx.

5. NRR Office Instruction LIC-401, NRR Reactor Operating Experience Program, available at https://usnrc.sharepoint.com/teams/NRR-OI-Listing/Lists/OI%20Listing/AllItems.aspx.

6. Inspection Procedure 36100, Inspection of 10 CFR Part 21 and 50.55(e) Programs for Reporting Defects and Noncompliance available at (http://www.nrc.gov/reading-rm/doc-collections/insp-manual/inspection-procedure/index.html).

7. Inspection Procedure 71152, Problem Identification and Resolution available at (http://www.nrc.gov/reading-rm/doc-collections/insp-manual/inspection-procedure/index.html).

8. Inspection Manual 2523, NRC Application of the Reactor Operating Experience Program in NRC Oversight Processes. (https://www.nrc.gov/reading-rm/doc-collections/insp-manual/manual-chapter/).

Enclosure:

Appendix A - Change History

Enclosure Appendix A - Change History Office Instruction LIC-403 LIC-403 Change History - Page 1 of 1 Date Description of Changes Method Used to Announce &

Distribute Training 04/12/2001 This office instruction is a revision of NRR Office Letter No. 1300, Revision 2, Procedures for 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 Their Vendors.

This revision accounts for changes in organization, responsibility, procedures, and office instruction format.

E-mail to all staff None 05/04/2005 This office instruction is a revision of NRR Office Instruction LIC-403, Procedures for 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 Their Vendors. This revision accounts for changes in organization, responsibility, and procedures.

E-mail to all staff None 08/12/2010 This office instruction is Revision 2 of NRR Office Instruction LIC-403, Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR 50.55(e)). This revision accounts for changes in organization, responsibility, and procedures. This revision also incorporates the recommended changes described in the response to NRR Yellow Ticket Y020090192, Process for Addressing Potentially Generic 10 CFR Part 21 Issues Reported by Licensees (ADAMS Accession No. ML100750235).

E-mail to all staff None 09/20/2011 This office instruction is Revision 3 of NRR Office Instruction LIC-403. This revision accounts for incorporation of the NRO process for handling Part 21 and 10 CFR 50.55(e) reports (NRO-REG-112). This revision is issued as a Joint NRR/NRO office instruction.

E-mail to all staff None 03/062020 This revision reflects the reunification of NRR and NRO and makes other necessary updates. This issuance incorporates and rescinds the related NRO instruction NRO-REG-122, Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR 50.55(e)), Revision 3.

E-mail to all staff None