ML25149A207
| ML25149A207 | |
| Person / Time | |
|---|---|
| Issue date: | 12/23/2025 |
| From: | Paul Laflamme NRC/NRR/DRO |
| To: | Office of Nuclear Reactor Regulation |
| References | |
| LIC-403, Revision 5 | |
| Download: ML25149A207 (0) | |
Text
OFFICE OF NUCLEAR REACTOR REGULATION LIC-403, Revision 5 Procedures for Handling Deficiency Reports (10 CFR Part 21, 10 CFR 50.55(e))
Volume 400 Events & Generic Communications Approved By:
Phillip J. McKenna Date Approved:
December 23, 2025 Effective Date:
December 29, 2025 Certification Date:
December 29, 2030 Responsible Organization:
DRO Primary Contacts:
Paul LaFlamme Chris Speer Paul.LaFlamme@nrc.gov Chris.Speer@nrc.gov 301-415-1184 301-415-0520 Summary: This revision reflects the 5-year review update of the office instruction. It updates formatting, minimizes unnecessary references to other documents such as LIC-401, updates guidance to be consistent with the applicable requirements and language of 10 CFR Parts 21, 50, and 52, and eliminates discussion of obsolete processes. No changes were made to performance metrics, overall responsibilities, or report categories.
Training:
ADAMS Accession Number:
None ML25149A207 TABLE OF CONTENTS 1.
POLICY.............................................................................................................................2 2.
OBJECTIVES....................................................................................................................2 3.
BACKGROUND................................................................................................................2 4.
BASIC REQUIREMENTS..................................................................................................2 5.
RESPONSIBILITIES AND AUTHORITIES........................................................................3 6.
PERFORMANCE MEASURES.........................................................................................4 7.
PRIMARY CONTACTS.....................................................................................................4 8.
RESPONSIBLE ORGANIZATION.....................................................................................5 9.
EFFECTIVE DATE............................................................................................................5 10.
CERTIFICATION DATE....................................................................................................5 11.
REFERENCES..................................................................................................................5
ML25149A207 OFFICE NRR/DRO/IOEB NRR/DRO/IOEB NRR/DRO/IQVB NRR/DRO/IRIB NAME Paul LaFlamme Brian Benney KKavanagh DBollock DATE 06/13/2025 12/11/2025 6/23/2025 6/16/2025 OFFICE NRR/DRO NRR/DANU NRR/DEX NRR/DSS NAME PMckenna Svasavada TNavedo JWhitman DATE 10/22/2025 11/14/2025 10/22/2025 11/17/2025 S
OFFICE NRR/DANU NRR/DRMA NRR/DNRL NRR/DORL NAME JGreives DMarcano MSampson ARivera-Verona DATE 11/17/2025 11/18/2025 11/18/2025 121/11/2025 OFFICE NRR/DRO NAME PMcKenna DATE 12/23/2025
NRR Office Instruction: LIC-403, Revision 5 Page 2 of 6 1.
POLICY This instruction describes the process used by the Office of Nuclear Reactor Regulation (NRR) to receive, screen, evaluate, and respond to notifications submitted in accordance with:
10 CFR Part 21 - Reporting of Defects and Noncompliance; 10 CFR 50.55(e) - Conditions of construction permits and combined licenses; 10 CFR 50.72 - Immediate notification requirements for operating reactors; and 10 CFR 50.73 - Licensee event report system.
These reports often describe failures or deviations in basic components that may represent a substantial safety hazard as defined in these regulations.
2.
OBJECTIVES The objective of this office instruction is to ensure timely and effective processing of deficiency notifications required under 10 CFR, ensuring:
Public health and safety; Regulatory compliance; Appropriate communication across NRC staff, licensees, and vendors; and Determinations of generic applicability and inspection follow-up.
3.
BACKGROUND Under 10 CFR Part 21 and 10 CFR 50.55(e), licensees and vendors must report defects or failures to comply that could result in a substantial safety hazard. Notifications include failures of basic components, design/construction deviations, or other safety-significant issues.
Reports may also be submitted under 10 CFR 50.72 or 10 CFR 50.73 when an event occurs at a nuclear facility.
4.
BASIC REQUIREMENTS Reports submitted under 10 CFR Parts 21, 50, and 52 form a critical part of the NRCs system for responding to potential or actual safety concerns. These reports are reviewed to determine:
Completeness under 10 CFR 21.21 and 10 CFR 50.55(e)(5);
Whether requests for additional information (RAIs) are needed; The need for additional inspection activities, generic communications; or internal dissemination under 10 CFR Parts 50, 52, or 21; and Whether the information supports agency-wide safety improvements or vendor oversight under 10 CFR Part 21.31.
NRR Office Instruction: LIC-403, Revision 5 Page 3 of 6 All reports are posted publicly in ADAMS and on the NRC website, in accordance with 10 CFR 2.390 for non-sensitive content.
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).
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) 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 website.
5.
RESPONSIBILITIES AND AUTHORITIES NRR Division Responsibilities Each NRR division is responsible for supporting evaluations related to reports submitted under the 10 CFR Parts 21 and 50.
Quality assurance or vendor inspection staff execute responsibilities related to:
Inspection of vendor programs for 10 CFR 21/50.55(e) compliance; Identification of generic safety issues; Coordinating rulemakings related to reporting requirements; and Verifying that deviations are properly evaluated as defined under 10 CFR 21.21(b) and 21.21(d)(4).
Subject Report Coordinator The Subject Report Coordinator (Coordinator) is a member of DRO and is the primary contact for this office instruction. The Coordinator performs the following tasks:
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; Organizes Subject Reports by assigning each Subject Report a unique identification number and tracking them in the RPS-Oversight ROE Part 21 database; Coordinates the screening and ADAMS posting of Subject Reports and ensures compliance with 10 CFR 2.390 when handling proprietary or sensitive information;
NRR Office Instruction: LIC-403, Revision 5 Page 4 of 6 Ensures that Subject Reports are reviewed for sensitive unclassified non-safeguards information before being made publicly available to stakeholders on the NRC external website; Contacts a licensee or vendor (with support from quality assurance or vendor inspection staff 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; Adds wording to the Part 21 description on the public website 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 Provides administrative updates to the RPS-Oversight ROE Part 21 database as required when the Subject Report is processed in accordance with this instruction.
Operating Experience Clearinghouse Team The OpE Clearinghouse Team (Clearinghouse) is responsible for screening each Subject Report to determine whether further evaluation, internal distribution, or agency awareness is warranted, in accordance with applicable requirements in 10 CFR Parts 21, 50, and 52. The screening process focuses on identifying reports that may involve defects, quality assurance deficiencies, or safety-significant issues with potential generic implications. In addition to making a screening determination, the Clearinghouse decides on appropriate internal distribution and ensures that applicable Subject Reports are tracked and posted to the NRC public website.
Additional information obtained through conversations or correspondence with licensees or vendors may be used to clarify the extent of condition or generic applicability. The Clearinghouse should consider the following factors when evaluating and distributing Subject Report information:
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, as described in 10 CFR 21.21(b);
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; When the notification is made under 10 CFR 50.72, 50.73, 73.71, or 50.55(e);
and When a report submitted under 10 CFR 50.55(e) describes a significant breakdown in any portion of the quality assurance program that could have produced a defect, consistent with 10 CFR 50.55(e)(3)(iii)(C).
The Clearinghouse ensures that all Subject Report information is distributed to appropriate NRC staff and subject matter experts, including personnel in headquarters offices, regional offices, and resident inspectors at potentially affected units. Responsibilities for communicating Subject Report information are
NRR Office Instruction: LIC-403, Revision 5 Page 5 of 6 documented in the Clearinghouse Screening Summary. The Clearinghouse is also responsible for identifying Subject Reports that are associated with required notifications under 10 CFR 50.72, 50.73, or 73.71 and ensuring that those reports are appropriately tracked, publicly posted, and screened in accordance with this procedure.
6.
PERFORMANCE MEASURES No formal performance measures are defined; effectiveness is assessed through inspection, public feedback, and internal NRC coordination on response actions.
7.
PRIMARY CONTACTS Paul LaFlamme - Paul.LaFlamme@nrc.gov l 301-415-1184 Chris Speer - Chris.Speer@nrc.gov l 301-415-0520 8.
RESPONSIBLE ORGANIZATION DRO 9.
EFFECTIVE DATE December 29, 2025 10.
CERTIFICATION DATE December 29, 2030 11.
REFERENCES 1.
U.S. Code of Federal Regulations, Reporting of Defects and Noncompliance, Part 21, Chapter 1, Title 10, Energy. (https://www.nrc.gov/reading-rm/doc-collections/cfr/part021/full-text.html) 2.
U.S. Code of Federal Regulations, Domestic Licensing of Production and Utilization Facilities, Part 50, Chapter I, Title 10, Energy.
(https://www.nrc.gov/reading-rm/doc-collections/cfr/part050/full-text.html) 3.
U.S. Code of Federal Regulations, Licenses, Certifications, and Approvals for Nuclear Power Plants, Part 52, Chapter 1, Title 10, Energy.
(https://www.nrc.gov/reading-rm/doc-collections/cfr/part052/full-text.html)
Enclosure:
Appendix A - Change History
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 Enclosure
2 LIC-403 Change History - Page 2 of 2 Date Description of Changes Method Used to Announce &
Distribute Training 12/23/2025 This revision reflects the 5-year review update of the office instruction. It updates formatting, minimizes unnecessary references to other documents such as LIC-401, updates guidance to be consistent with the applicable requirements and language of 10 CFR Parts 21, 50, and 52, and eliminates discussion of obsolete processes. No changes were made to performance metrics, overall responsibilities, or report categories.
E-mail to all staff None