ML24157A065

Jeffs 2024 Workshop Presentation

ML24157A065
Person / Time
Site:	Diablo Canyon
Issue date:	06/13/2024
From:	Kaar J Pacific Gas & Electric Co
To:	Office of Nuclear Reactor Regulation
References
Download: ML24157A065 (24)

Text

NRC Vendor Oversight Workshop:

Utility Perspective on 10 CFR Part 21 Jeff Kaar Supervisor, Nuclear Supplier Audits Diablo Canyon Power Plant June 13, 2024

Public How Utility Implements Part 21 10 CFR Part 21 addresses:

1. Commercial Grade Dedication (CGD, §21.3 - Definitions)

2. Sign Posting requirements (§21.6)

3. Report of Defects (§21.21) - Notification of failure to comply or existence of a defect and its evaluation 10 CFR Part 21 establishes requirements for procedures to evaluate and report to implement §206, Noncompliance, of The Energy Reorganization Act 1974.

Public Who is Affected?

• An estimated 2,000 licensees, vendors, and fuel/waste facilities are under the scope of 10 CFR Part 21.

• NRC staff estimates receiving 88 reports yearly for a cost of approximately $1.2 Million. (49 hours5.671296e-4 days <br />0.0136 hours <br />8.101852e-5 weeks <br />1.86445e-5 months <br /> x $275/staff hr.)

• Industry burden for reporting, recordkeeping, and third-party disclosure for 10 CFR 21 is estimated at $8.8 Million.

Public Structure of the Rules

• 10 CFR 21 issued in 1977, effective 1/6/1978, and revised in 2009

• NUREG-0302, rev. 1, July 12-26, 1977 Reporting of Defects &

Noncompliance; (Public Comments; ML062080399).

• NUREG-1022 Event Report Guidelines 10 CFR 50.72 and 50.73, Revision 2 (Oct 2000) replaced by Revision 3 (Jan. 2013).

• Guidance for Part 21 removed

• NEI 14-09, Revision 1, Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects & Noncompliance, February 2016.

• Regulatory Guide 1.234, Revision 1, 2018, endorses NEI 14-09.

Public Structure of the Rules (continued)

• 10 CFR Part 21 lists other regulations subject to Part 21, but these other regulations do not usually state Part 21 applies. For example, 10 CFR 50 Appendix B does not mention Part 21.

• Duplicate reporting under 10 CFR Part 21 is not required. The reports submitted to satisfy other regulatory reporting requirements (e.g., 10 CFR 50.72 and 50.73) can also be used to satisfy reporting requirements of Part 21. However, report should state it is being submitted to satisfy 10 CFR Part 21 and include appropriate details.

• Refer to NRC Form 366, Licensee Event Report, mark other box

Public Where Does Part 21 Apply?

• Each procurement document for a basic component must specify that the provisions of 10 CFR Part 21 apply.

• A part on the shelf is considered a delivered component applicable to 10 CFR Part 21.

• 10 CFR Part 21 will apply to the commercial grade dedicating entity (utility or 3rd-party dedicator is now Original Equip. Mfr.-OEM).

• What if just Part 21 without plant effect (50.72)?

• Call NRC operation hotline (but NRC will want a letter laterso why call? Deadline, expediency to make deadline, or

• Letter (Licensing group / CNO to NRC) or Form 366.

Public Reporting Using The LER Form NRC Form 366, Licensee Event Report

Public How Utility Implements Part 21

Public Definitions (10 CFR § 21.3)

• Basic Component: a structure, system, or component, or part thereof that affects its safety function necessary to assure:

• integrity of Rx Coolant Pressure Boundary;

• capability to shut down Rx and maintain safe shut down;

• capability to prevent or mitigate consequences of accidents that could result in offsite exposure

• Deviation: departure from the technical requirements included in a procurement document (additional 3 design examples listed )

• Discovery: completion of document 1st identifying existence of deviation (or failure to comply) potentially associated with substantial safety hazard, if it were to remain uncorrected. (Hint: Enter in Corrective Action Program system)

Public Definitions (10 CFR § 21.3)

• Defect: A deviation in a delivered (installed, used, in operation) basic component to a purchaser on basis of an evaluation, the deviation could create a substantial safety hazard (or contribute to exceeding safety limit). Note 4 sub-clarifications are listed).

• Evaluation: process of determining whether a particular deviation could create a substantial hazard (or determining whether a failure to comply is associated with a substantial safety hazard).

• Substantial safety hazard: a loss of safety function resulting in a major reduction in protection to public health & safety for any licensed facility or activity (10 CFR parts 30, 40, 50, 52, 60, 61, 63, 70, 71, or 72). The 3 categories of substantial safety hazards are Moderate Exposure, Major Degradation, and Major Deficiency.

Public Definitions (10 CFR § 21.3)

• Moderate Exposure: exposure in excess of 25 rem whole body or to an individual in unrestricted area of 0.5 rem

• Major Degradation: loss of safety related equipment redundancy if, in conjunction with a single failure, a required safety function could not be performed. Loss of redundancy is a major reduction protection degree provided to public health &safety. Exceeding a safety limit facility technical specification is a major degradation.

• Major Deficiency: a condition or circumstance involving the design, construction, inspection, test could contribute to exceeding a safety limit or cause an accident.

Public Interpreting the Rules

• If Commercial items are not basic components and are not subject to 10 CFR Part 21 evaluation and reporting requirements (including commercial grade items that have not yet completed a dedication acceptance process; *which could include installation testing). *

• Has the basic component with a deviation been delivered? If not delivered, not Part 21 for end user.

• Purchaser may be entitled by contract or normal process, to perform receipt inspection before final component acceptance. In that case, delivery would not occur and no notification to NRC by the purchaser required where purchaser conducts receipt inspection and rejects/returns component to the supplier (within a reasonable time period).

Public Interpreting the Rules (continued)

• In this same situation, the supplier who receives the rejected component would be required to evaluate the deviation and report an identified defect if they had delivered components with similar deviations to other facilities or activities subject to Part 21.

• Suppliers should be cognizant that they may have shipped other items with the same deviation and therefore must consider the applicability of Part 21 evaluation and reporting requirements.

• If the supplier identifies a deviation in basic components delivered to other facilities or activities subject to Part 21, then supplier should notify the other purchasers, and evaluate and report the defect pursuant to 10 CFR Part 21.

• However, supplier is not required to perform a Part 21 evaluation for the item that was rejected, because the item was never delivered.

Public Interpreting the Rules (continued)

A key component of the evaluation is if it were to remain uncorrected therefore, QA inspections or tests performed by the licensee cannot be counted upon to prevent installation of defective basic components.*

Facility Technical Specifications may allow continued operation for short periods of time with a redundant component inoperable. Operation in such a mode is not considered to be a substantial safety hazard defined in 10 CFR Part 21. However; it is possible that the failure could identify a deviation, i.e.,

a departure from technical requirements of the procurement document under which the component was purchased. If the deviation is for a delivered basic component, then it would need to be evaluated pursuant to 10 CF Part 21.

In cases where it can be documented there is no potential for a substantial safety hazard, reporting is not required.

Public Rule Summary

• What does Part 21 ask Designers, Dedicators, Constructors, Suppliers and Utilities to do?

1. Evaluate deviations (and failures to comply to identify defects) associated with substantial safety hazards ASAP and within 60 days.

2. If cannot be completed within 60 days from discovery an interim report submitted to NRC

3. Responsible officer informed ASAP and within the 5 working days after evaluation completion.

• The communication may be by fax, phone, or written, but NRC will ask for detailed follow-up.

Public Lessons Learned PG&E Examples include:

1. Whole component dedication on Emergency Diesel Generator (EDG)

2. Vendor Audit Discovery

3. Snubber testing anomaly Summary

Public Lessons Learned (continued)

• Whole component dedication: PG&E purchased and installed five original EDGs in 1974. After encouragement, purchased and installed a sixth EDG, same as the current make/model. Created Dedication document for whole & parts (5,000 pages)

• In 2022 (30 years later) developed fuel leak in header to one of 18 cylinders at a rate of 8 oz/minute. Leaks fall into pan routed back to day tank.

• The cause of the leak was weld imperfection that propagated to a small crack; weld was repaired and the EDG returned to service.

• Paradigm shift: +All broken equipment CAP has a LER review (P21)

• Always loop in Procurement to ask How did we buy it?

Public Lessons Learned (continued)

Public Lessons Learned (continued)

• Vendor Audit Discovery

• NUPIC Significant Audit Finding - code word for Part 21 or major QA program breakdown.

• During audit report and package review, challenged checklist statement for problem significant and no audit finding identified.

• Auditor reluctant to identify unissued commercial grade survey meant sub-supplier qualification expired. CGD is defined in Part 21.

• Entered NUPIC Significant Audit Finding process, Vendor identified affected sub-suppliers (2) and 14 utility customers.

• Vendor requalified one vendor per NEI 14-07 (calibration) and 2nd had not yet been used. Vendor issued CAPs for not issuing Report and for not identifying in CAP.

• Auditor qualification pulled till retrained/retired.

Public Lessons Learned (continued)

• Snubber testing anomaly (Deviation) during outage testing.

• Met to discuss next steps (expand population/anomaly significance)

• Evaluate Part 21 was in meeting invitation. QA and Licensing present

• Engineer created CAP assignments but held until vendor received items.

• Discovery exceeded 60-day evaluation - did not click start

• What happens if miss timeliness - NRC cites you (failure to make a required report that impedes its ability to take regulatory action)

• Utility phrase: You write it or I will and you wont like my version.

• Vendor phrase: Libel me and I will sue you.

• Reality: We are All in this together.

• Part 21 reporting: Warning your Nuclear Brothers & Sisters/NRC not blame

• Vendor must maintain evaluation (document) before sends to utility

Public Conclusion - All In This Together

• Part 21 does three things:

1. Gives definitions including Establish Commercial Grade Dedication

2. Establish Sign Posting Requirements; and

3. Establish rule to Notify Part Problem

• Point of Notification is not to establish responsibility or blame, rather to warn your Nuclear Brothers and Sisters (& NRC): Oops, we have a problem, check if you do too.

• Process - Defect / Deviation / Discovery / Defect / follow procedure &

watch the clock; better to call NRC than be cited

• KISS / right size problems - use Corrective Action Program accordingly

• Your signature means something

Public Q&A/Shameless Advertising

• Questions: (step up to microphone or cards)

• If you like this forum, please know NUPIC and NRC meet jointly every even year (next in 2026)

• NUPIC has a vendor committee that organizes annual June vendor meetings.

• Advisory committee of vendors who suggest topics

• Volunteers welcome!

• Suggested topics welcome!

• Goal is to disseminate information, educate, and discuss issues.

Vendors, regulators, and utilities are all welcome to attend our annual vendor meeting in mid-June 2025 (Austin, TX)

Public Questions?

Thank You Jeff Kaar Jeffrey.Kaar@pge.com