ML20055F510

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LIC-114, Revision 1, Title 10 of the Code of Federal Regulations (10 CFR) Section 52.103(g) Finding and Communication Process - Appendix C, Basic Document
ML20055F510
Person / Time
Issue date: 06/12/2020
From: Ho Nieh
Office of Nuclear Reactor Regulation
To:
Office of Nuclear Reactor Regulation
Welch C, NRR/VPO, 301-415-7000
Shared Package
ML20055E096 List:
References
LIC-114, YT20190127
Download: ML20055F510 (29)
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APPENDIX C Basis Document LIC-114, Revision 1 "Title 10 of the Code of Federal Regulations (10 CFR) Section 52.103(g)

Finding and Communication Process"

10 CFR 52.103(g) Basis Document

[Plant Name]

[Docket #]

[License #]

This document describes the basis for the U.S. Nuclear Regulatory Commission (NRC) staffs determination that the acceptance criteria in combined license [license #], Appendix C, [enter title], are met. This determination will be used to support a formal finding, under Title 10 of the Code of Federal Regulations (10 CFR) 52.103(g), that all acceptance criteria in the combined license are met, which allows operation of the facility to begin.

[As discussed in NEI 08-01, Industry Guideline for the ITAAC Closure Process Under 10 CFR Part 52, the licensees All ITAAC Complete notification, required by 10 CFR 52.99(c)(4) and received on [date], informed the staff that [(1) all inspections, tests, and analyses (ITAs) in the combined license have been completed, (2) all acceptance criteria are met, (3) all inspections, tests, analyses, and acceptance criteria (ITAAC) closure notifications (ICNs) have been submitted, (4) the licensee is not aware of any condition warranting submission of an ITAAC post-closure notification (IPCN), and (5) the licensee is maintaining the successful completion of all ITAAC pending the NRCs 10 CFR 52.103(g) finding. {Update paragraph based on content of the All ITAAC Complete notification as required}].

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Table of Contents 1.0 RECOMMENDATION 2.0 GENERAL DISCUSSION 3.0 ITAAC NOTIFICATIONS10 CFR 52.99(c) 3.1 ITAAC Closure Notification (ICN)10 CFR 52.99(c) (1) 3.2 ITAAC Post-closure Notification (IPCN)10 CFR 52.99(c)(2) 3.3 Uncompleted ITAAC Notification (UIN)10 CFR 52.99(c)(3) 4.0 CONSTRUCTION REACTOR OVERSIGHT PROCESS 4.1 ITAAC Prioritization Process 4.2 Construction Inspection Program 4.3 Reactor Construction Assessment 4.4 Vendor Inspection Program 5.0 Conclusion ATTACHMENTS

1. Construction Inspection Reports
2. Plant Assessment Letters
3. Vendor Inspection Reports
4. ITAAC Findings C-2

1.0 RECOMMENDATION The staff has determined that [licensee name] has met all the acceptance criteria in Appendix C to the [plant name] combined license [license #].

The staff therefore recommends that the [Director, Office of Nuclear Reactor Regulation]

issue an affirmative finding that the acceptance criteria are met under 10 CFR 52.103(g),

which will allow operation of the facility to begin.

2.0 GENERAL DISCUSSION Section 185b. (42 U.S.C. 2235(b)) of the Atomic Energy Act of 1954, as amended (AEA),

and 10 CFR 52.97(b) require that the Commission identify within the combined license the ITAs, including those applicable to emergency planning, that the licensee shall perform, and the acceptance criteria that, if met, are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the AEA, and the Commissions rules and regulations. To fulfill this requirement, the Commission included ITAAC in Appendix C to the combined license for [plant name].

Following issuance of the combined license, Section 185b. requires that the Commission ensure that the prescribed ITAs are performed, and before operation of the facility, find that the prescribed acceptance criteria are met. The NRC codified the requirement to ensure completion of the ITAs in 10 CFR 52.99(e) and codified the requirement to find that the acceptance criteria are met in 10 CFR 52.103(g).

The staff implemented a two-pronged approach to fulfill these requirements. First, the staff reviewed 100 percent of the licensees ICNs submitted under 10 CFR 52.99(c)(1).

These reviews verified that the licensee provided a sufficient basis to demonstrate that the ITAs were performed as required and that the results met the prescribed acceptance criteria. [The staff also reviewed 100 percent of the IPCNs submitted under 10 CFR 52.99(c)(2) to verify that the ITAAC were still satisfied notwithstanding new, material information.] Second, the staff performed independent inspections of a carefully selected sample of ITAAC to independently verify (1) the licensees performance of the ITAs and (2) that the obtained results met the prescribed acceptance criteria.

Additionally, these inspections also verified that the licensee (1) had quality construction programs, processes, and procedures, (2) provided adequate quality assurance (QA) oversight of construction activities, and (3) identified and corrected conditions adverse to quality. Moreover, a sample of the ICNs were inspected against their associated closure packages to verify the accuracy of the information reported in the ICNs.

The staff verified that [licensee name] performed the required ITAs and met all the acceptance criteria in Appendix C to the combined license [license #] through ongoing activities that began before the issuance of the combined license and which were concluded following submission of the licensees All ITAAC Complete notification on

[date], pursuant to 10 CFR 52.99(c)(4).

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As discussed below in Sections 3 and 4, the principal basis for the staffs determination that the acceptance criteria are met is the staffs review of the licensees ITAAC notifications under 10 CFR 52.99(c) coupled with the results of the staffs oversight activities. These oversight activities included construction inspections, vendor inspections, activities of the onsite resident inspectors, public meetings, and the routine and periodic assessment of the licensees performance.

The Commission, in the July 19, 2013, Staff Requirements Memorandum for SECY-13-0033, Allowing Interim Operation under Title 10 of the Code of Federal Regulations Section 52.103, delegated the responsibility for the 10 CFR 52.103(g) finding to the staff. Pursuant to 10 CFR 52.103(h), after the staff makes the 10 CFR 52.103(g) finding, the ITAAC do not, by virtue of their inclusion in the combined license, constitute regulatory requirements for the licensee. All ITAAC expire upon final Commission action in the proceeding, [except for the specific ITAAC for which the Commission has granted a hearing under 10 CFR 52.103(a)].

While ITAAC are no longer requirements after the 10 CFR 52.103(g) finding, subsequent changes to the facility or procedures described in the final safety analysis report (as updated) must comply with the requirements in 10 CFR 52.98(e) or (f), as applicable.

The technical specifications in the combined license [license #], Appendix A, [title],

become effective upon a finding that the acceptance criteria in the license (ITAAC) are met in accordance with 10 CFR 52.103(g).

3.0 ITAAC NOTIFICATIONS10 CFR 52.99(c)

In 10 CFR 52.99(c), the NRC requires that the licensee submit to the NRC the following ITAAC notifications:

After each ITAAC was completed, the licensee, pursuant to 10 CFR 52.99(c)(1),

submitted to the NRC an ICN, which the staff reviewed in accordance with the Office of Nuclear Reactor Regulation (NRR) Office Instruction (OI) LIC-211, Inspections, Tests, Analyses, and Acceptance Criteria Closure Verification Process. The staff also considered the ITAAC closure guidance in NEI 08-01, which was developed in a lengthy process involving public meetings and extensive comments from the staff. In Regulatory Guide 1.215, Guidance for ITAAC Closure under 10 CFR Part 52, the NRC approved the use of NEI 08-01, subject to certain exceptions and additional guidance stated in Regulatory Guide 1.215.

In accordance with the 2007 final rule amending 10 CFR Part 52 (72 FR 49352, 49366; August 28, 2007), the NRC expects the notification to be sufficiently complete C-4

and detailed for a reasonable person to understand the bases for the licensees representation that the ITAs have been successfully completed and the acceptance criteria met. NEI 08-01 defines a reasonable person as someone who is appropriately informed about and familiar with applicable NRC regulations, licensing requirements, and technical or engineering concepts related to ITAAC.

When evaluating for sufficient information, the staff required, at a minimum, a summary description of the basis for the licensees conclusion that the ITAs were performed and that the prescribed acceptance criteria are met. A simple statement that the ITA activities were performed or that the acceptance criteria of an ITAAC are met or both was not acceptable. The summary description had to address at a minimum (1) the full scope of the ITAAC, (2) the licensees ITAAC completion methodology, and (3) distinctive aspects of the ITAAC. The staff, to aid in its review, referred to the guidance and example ITAAC notifications in NEI 08-01.

These ICN reviews did not involve independent verification of whether the licensee had adequately performed the ITAAC activities described in the notification, as this is an inspection function discussed below in Section 4. Likewise, a closure verification review was not meant to be an in-depth technical review of all aspects of an ITAACs implementation. Rather, it was an assessment of whether the information provided was sufficient to support the licensees assertion that the ITAs were successfully completed and the acceptance criteria are met.

For each ICN, the reviewer verified that the licensee had performed the ITAs as required and demonstrated that it had met the acceptance criteria. The reviewer accomplished this by comparing the information in the notification with the performance requirement(s) specified in the ITAs and the prescribed acceptance criteria. The ITAs may have required only one activity or a combination of up to three different types of activities:

(1) inspections, (2) tests, and (3) analyses. These activities, including other terms commonly used in the ITAAC, are defined in Appendix C to the combined license. The reviewer verified that the activities the licensee performed, as stated in the ICN, agreed with those definitions, and matched the activities specified in the ITAAC. For example, if the ITAs required an inspection and an analysis, the reviewer verified that the ICN indicated that the licensee had performed both activities. The licensee may have performed additional activities; however, if the licensee implemented fewer activities than required in the ITAs, the ITAAC was not successfully performed, the licensees ICN was rejected, and a new ICN was submitted that addressed all required activities.

The acceptance criteria in the ITAAC may have required a specific performance, physical condition, test, or analysis result for a structure, system, or component (SSC) to demonstrate that the design requirement stated in the design commitment for the ITAAC is met. Each reviewer verified that for each ITAAC the outcome achieved met the prescribed acceptance criteria.

The ITAAC closure Verification and Evaluation Form served to guide and document the staffs closure review. For each ICN, the staff verified the following:

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  • that the ICN included the correct licensee, plant name, unit number, and NRC docket number
  • that the ITAAC in the ICN agreed verbatim with the ITAAC in the current approved version of the combined license at the time of ICN submittal
  • that the ITAAC determination basis (IDB) contained sufficient information, including a summary of the methodology for performing the ITAAC, to demonstrate that the licensee had successfully performed the ITAs stated in the ITAAC
  • that the methodology described in the ICNs IDB was either reviewed and approved by the NRC or was acceptable based on sound scientific, mathematical, or engineering principles and would be repeatable, if necessary, without any significant change to the reported result
  • that the IDB of the ICN contained sufficient information to demonstrate that the licensee had fully met the entire acceptance criterion stated in the ITAAC
  • that all planned NRC inspections were completed for the ITAAC
  • that NRC inspectors identified no ITAAC findings for the ITAAC or that any ITAAC findings were closed (an ITAAC finding is an NRC inspection finding that is associated with a specific ITAAC and is material to the ITAAC acceptance criteria)
  • for ITAAC specified as being performed on as-built SSCs, that an acceptable technical justification was provided if the ITAs were performed at locations other than the final installed location
  • that the signature of a licensee representative affirmed the completion of the ITAAC The staff rejected ITAAC notifications that lacked sufficient information to demonstrate that the licensee had successfully performed the ITAAC. The staff communicated this to the licensee either informally through public meetings or formally through written correspondence. Whenever the staff rejected an ICN, the licensee was always required to revise the ICN to address the insufficient information and submit a new ICN of record to the NRC.

The NRCs Verification of ITAAC Closure, Evaluation, and Status (VOICES) database tracks the closure verification status for each ITAAC. VOICES contains prepopulated entries for each ITAAC entry in Appendix C to the combined license. As the licensee completed the ITAAC, its associated VOICES entry was updated with the ITAAC status and Web links to the ICN submittal, the completed Verification and Evaluation Form, and any NRC inspection reports for that ITAAC.

Throughout the construction period, the staff periodically posted the licensees ICNs and the staffs determinations on whether the ITAAC were successfully completed in an C-6

ITAAC Status Report posted on the NRCs public Web site. In addition, up until the last date for submission of requests for a hearing under 10 CFR 52.103(a), the staff, at appropriate intervals during construction, published Federal Register notices of its determinations that ITAAC were successfully completed pursuant to 10 CFR 52.99(e).

The licensees ICN for each ITAAC in Appendix C to combined license [license #], along with the associated Verification and Evaluation Form completed by the staff, may be accessed via the final ITAAC Status Report for [plant name], available at [Agencywide Documents Access and Management System (ADAMS) accession number for final ITAAC Status Report].

The [plant name] combined license [license #] originally contained [number] initial ITAAC entries. [number of ITAAC] of the ITAAC entries were from [Revision # of the [design name] design control document and [number] were [plant name)) site-specific ITAAC.

Throughout the construction period, the NRC approved license amendment and exemption requests submitted by the licensee that modified the number and content of the ITAAC. At the time of receipt of the All ITAAC Complete notification on [date], the

[plant name] combined license [license #] was at license amendment [number], and Appendix C contained [number] ITAAC.

For each of the [number] ITAAC in the license, the staff verified that a corresponding ITAAC entry existed in VOICES, the licensee had submitted the required ICN, and the staff had verified that the ICN had sufficient information to demonstrate that the ITA were performed and the acceptance criteria are met.

The NRC staffs periodic determinations of successful ITAAC completion were based on information available at the time and were subject to the licensees ability to maintain successful ITAAC completion. The ITAAC closure process is not finalized for such ITAAC until the NRC makes an affirmative finding under 10 CFR 52.103(g).

3.2 ITAAC POST-CLOSURE NOTIFICATION10 CFR 52.99(c)(2)

Subsequent to the submittal of an ICN, if the basis for ITAAC completion is materially altered by new information, the licensee is required by 10 CFR 52.99(c)(2) to notify the NRC of this new material information in an IPCN. This notification must be submitted in a timely manner and must demonstrate that, notwithstanding the new information, the ITAAC have been successfully completed.

A post-closure notification need not be submitted following all maintenance or repairs affecting an SSC covered by an ITAAC. Rather, an IPCN is required only if one of five thresholds is exceeded. NEI 08-01 discusses these thresholds with numerous examples. The rule creating 10 CFR 52.99(c)(2) (77 FR 51880, 51888; August 28, 2012) discussed five ITAAC maintenance thresholds for when an IPCN would be required:

(1) Material Error or OmissionIs there a material error or omission in the original ICN?

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(2) Post-work VerificationWill the post-work verification use a significantly different approach than the original performance of the ITAs as described in the original ICN?

(3) Engineering ChangeWill an engineering change be made that materially alters the determination that the acceptance criteria are met?

(4) Additional Items To Be VerifiedWill additional items need to be verified through the ITAAC?

(5) Complete and Valid ITAAC Closure RepresentationWill any other licensee activities materially alter the ITAAC determination basis?

If an ITAAC maintenance threshold has been exceeded, the licensee may need to take actions such as (1) reperformance of the ITAs, (2) performance of an alternative method of verification, or (3) submission of a license amendment and possibly an exemption request.

As discussed in NEI 08-01, a licensee should voluntarily notify the NRC of new information that materially alters the determination basis for a previously completed ITAAC within 7 days of discovery and within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery if the All ITAAC Complete notification has been submitted. In addition to these notifications, the staffs knowledge of the licensees need to submit an IPCN was supplemented by the onsite construction resident inspectors daily review of the licensees corrective action program documents. The staff also reviewed the results of the NRCs periodic inspections pursuant to Inspection Procedure (IP) 40600, Licensee Program for Managing Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) Closure, one aspect of which verified compliance with 10 CFR 52.99(c)(2).

[For each IPCN, the staffs review verified that the IPCN described the resolution of the circumstances surrounding the identification of the new material information and that the IPCN provided sufficient information to demonstrate that, notwithstanding the new information, the prescribed ITAs were completed and the acceptance criteria met. The staff conducted its IPCN reviews in accordance with NRR-LIC-211 and completed an associated Verification and Evaluation Form in a manner similar to that discussed above for ICNs.

The licensees IPCNs, along with the staffs completed Verification and Evaluation Forms, may be accessed via the final ITAAC Status Report, available at [ADAMS accession number for final ITAAC Status Report)).

3.3 UNCOMPLETED ITAAC CLOSURE NOTIFICATION10 CFR 52.99(c)(3)

For those ITAAC not completed as of 225 days before scheduled fuel load, 10 CFR 52.99(c)(3) requires the licensee to submit uncompleted ITAAC notifications (UINs) to the NRC by this date. UINs must provide sufficient information to demonstrate that the uncompleted ITAAC will be completed successfully.

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The UINs principally serve to support the 10 CFR 52.103(a) hearing process by providing information to interested stakeholders and the public on how the licensee intends to accomplish the uncompleted ITAs and demonstrate that it will meet the stated acceptance criteria. UINs did not play a formal role in the staffs determination of whether the acceptance criteria are met because for each UIN, the licensee was required to submit an ICN after the ITAAC was completed.

[Though the NRC was not required to review the UINs, the staff agreed with the licensees request that the staff review the UINs submitted by [licensee name] for [plant name]. These reviews provided for the early identification and resolution of issues related to the interpretation of ITAAC requirements, the ITAACs scope, and the clarity and sufficiency of the information provided as the basis to demonstrate the licensees planned performance of the ITAAC.]

The UINs [and the staffs associated UIN review checklist] may be accessed via the final ITAAC Status Report, available at [link to ADAMS document for final ITAAC Status Report]. [The results of the staffs UIN reviews were not published in the Federal Register.]

4.0 CONSTRUCTION REACTOR OVERSIGHT PROCESS The principal objective of the construction reactor oversight process (cROP) and its companion construction inspection program (CIP) is to provide reasonable assurance that the facility has been constructed and will be operated in conformance with the license, the provisions of the AEA, and the Commissions rules and regulations.

To meet this objective, the staff inspected licensee activities and processes in the three strategic performance areas: construction reactor safety, operational readiness, and safeguards programs. These performance areas contain the following six cornerstones of safety (Figure 2):

a. For the construction reactor safety area, the cornerstones of safety are as follows:
  • Design/Engineering: The objective of this cornerstone is to ensure that licensees adequately develop and implement programs and processes for design and engineering controls.
  • Procurement/Fabrication: The objective of this cornerstone is to ensure that licensees adequately develop and implement programs and processes for procurement and fabrication activities.
  • Construction/Installation: The objective of this cornerstone is to ensure that licensees adequately develop and implement programs and processes to ensure the construction and installation of facilities and SSCs are in accordance with the design.

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  • Inspection/Testing: The objective of this cornerstone is to ensure that licensees adequately develop and implement programs and processes to inspect and test programs, facilities, and SSCs.
b. For the operational readiness area, the cornerstone of safety is as follows:
  • Operational Programs: The objective of this cornerstone is to ensure that licensees adequately develop and implement the operational programs required by a license condition or regulation.
c. For the safeguards programs area, the cornerstone of safety is as follows:
  • Security Programs for Construction Inspection and Operations: The objective of this cornerstone is to provide assurance that (1) fitness-for-duty issues do not adversely impact construction activities and (2) the licensees security programs use a defense-in-depth approach and can protect against the design-basis threat of radiological sabotage from internal and external threats.

The cROP and the CIP were implemented per Inspection Manual Chapter (IMC) 2506, Construction Reactor Oversight Process General Guidance and Basis Document; IMC 2505, Periodic Assessment of Construction Inspection Program Results; IMC 2503, Construction Inspection Program: Inspection of Inspections, Tests, Analyses and Acceptance Criteria (ITAAC) Related Work; and IMC 2504, Construction Inspection ProgramInspection of Construction and Operational Programs.

As applied to the ITAAC, the cROP and CIP aim to provide a sufficient basis to support a staff determination on whether the acceptance criteria in the combined license are met.

This includes providing the necessary confidence that the licensees ITAAC completion and verification processes were effective and that the licensees ITAAC notifications were sufficient and accurate.

Based on the CIP results and periodic assessments of the licensees performance throughout construction per IMC 2505, the staff is confident that the stated objectives of the cROP and CIP were met, that the licensees ITAAC completion and verification processes were effective, and that the licensees ITAAC notifications were sufficient and accurate to support the staffs 10 CFR 52.103(g) finding, as discussed below.

4.1 ITAAC Prioritization Process While the scope of the NRCs inspection programs is comprehensive, 100-percent inspection was neither necessary nor efficient when evaluating licensee performance.

For this reason, the NRC historically has relied on a sample-based inspection program.

For [plant name], the CIP focused on a select sample of predefined inspection targets (i.e., targeted ITAAC).

The methodology for prioritizing the ITAAC for inspection was based in part on a quantitative process called the Analytic Hierarchy Process (AHP). AHP is a method of C-10

comparison used to reduce the subjectivity in prioritization and provide structure to the decision-making process. The prioritization process was managed such that the rating given each ITAAC correlated to the amount of assurance one could obtain from inspecting that ITAAC. In this way, it was not the ITAAC that was prioritized, but rather the value of inspecting that ITAAC, to maximize the agencys ability to detect any significant construction flaw.

The Technical Report on the Prioritization of Inspection Resources for Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC), dated September 30, 2005 (ADAMS Accession No. ML060740006) contains further detail on the AHP process. The process of populating the ITAAC Matrix (Figure 1) and prioritizing the ITAAC for inspection is described in OI NRR-LIC-210, Prioritization of Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) for Inspection. The ITAAC selection approach ensured that a diverse set of ITAAC were inspected, such that the results of the inspection process were representative of the entire ITAAC population.

The grouping of ITAAC into a matrix supported the identification and use of consistent inspection guidance for similar ITAAC within a single design and was structured to integrate into the NRC inspection program certain complementary inspection activities that evaluated the licensees control of the relevant construction processes.

As a planning tool, the ITAAC Matrix (Figure 1) identified 25 core inspection procedures (IPs) (Table 1) that comprised a comprehensive set of construction programs and construction processes that the NRC believes encompass those combined license holder activities involved in the quality construction of a nuclear power plant. A review of the matrixs six column titles (i.e., the programmatic activities) and the 19 matrix row titles (i.e., the SSCs and process activities) reveals those activities that represent the technical disciplines and programmatic controls that were used not only to fabricate and install the SSCs, but also to check, test, and confirm that the completed as-built facility will perform as designed.

Three additional IPs were added to provide inspection guidance for design acceptance criteria in the areas of safety-related piping design, pipe rupture hazard analysis, and digital instrumentation and control system/software. A fourth was added for the Human Factors Engineering Integrated System Validation ITAAC. Table 1 identifies these procedures.

The staff had initially decided that all ITAAC related to security, emergency planning, and design acceptance criteria would be targeted for inspection; therefore, these ITAAC were excluded from the initial prioritization process. The remainder of the NRCs inspection sample focused on ITAAC activities determined to have a value of inspection, based on the output of the prioritization ranking process, equal to or greater than [0.4].

These predefined inspection targets (referred to as targeted ITAAC) make up the CIPs baseline inspection program.

Changes to the targeted ITAAC population were made throughout construction in accordance with Appendix D to OI LIC-210. These changes were made in response to C-11

issued license amendments that modified, added, or deleted ITAAC in Appendix C to the COL.

[Additional changes to the targeted ITAAC population were implemented in January 2020 (ADAMS Accession No. ML19329C875). Changes included un-targeting ITAAC that were duplicative of other targeted ITAAC, eliminating the staffs positions to inspect (i.e., target) all emergency preparedness and security ITAAC and at least one ITAAC within each ITAAC family irrespective of the rank value of inspection. The changes were implemented in accordance with IMC 2506, Appendix B, Construction Inspection and Assessment Program Bases, Section B.03.13, Process for the Modification of the ITAAC Target Set. The changes were made to be more risk informed, use inspection resources more effectively, and to incorporate lessons learned from the NRCs ongoing assessment of licensee performance and prior inspection results of the targeted ITAAC.

With these changes, the targeted ITAAC population continued to provide confidence that the licensees ITAAC completion and verification processes are effective and to provide reasonable assurance that licensee ITAAC closure and post-closure notifications are sufficient and accurate.]

Based on the initial targeting and subsequent changes, the NRC targeted for inspection approximately [#] percent of the [plant name] ITAAC population. The list of targeted ITAAC for [plant name] is available in ADAMS [ML######] and on the NRCs public Web site.

4.2 Construction Inspection Program The nature of ITAAC activities calls for periodic inspections over the course of the entire construction project, with inspection timing corresponding to ongoing or recently completed licensee activities. The schedule for the staffs ITAAC-related inspections was periodically assessed, and inspections were re-prioritized as necessary to correspond with the current state of knowledge of the licensees schedule and the licensees performance. The need to adjust inspection samples was also periodically assessed according to the guidance in IMC 2505.

To implement the CIP, inspection planning occurred well in advance of actual inspection and began with the development of inspection strategy documents for each ITAAC family. The inspection strategy documents included a description of the ITAAC family, IPs to be used, applicable SSCs to be inspected, attributes of the IPs to be completed to credit an inspection sample, a representative sample for each targeted ITAAC, inspection frequency (including a sample range and resource estimate), other planning considerations, and references.

The inspection of each targeted ITAAC was considered complete when the site-specific plan was final. This means that, after adjustment by the assessment process, the necessary targeted ITAAC samples and associated programs were inspected, the SSCs designated in the plan were inspected, the designated steps of each row procedure were addressed, and the designated steps of each column procedure were addressed.

IMC 2506 defines an inspection finding as a performance deficiency of more than minor significance. A finding may or may not be associated with regulatory noncompliance C-12

and, therefore, may or may not result in a violation. Two types of construction inspection findings can be identified through implementation of the CIP:

(1) An ITAAC Finding is identified through the implementation of the CIP that is associated with a specific ITAAC and is material to the ITAAC acceptance criteria.

(2) A Construction Finding is a finding that is identified through the implementation of the CIP and is not an ITAAC finding.

The staff verified that each construction inspection finding and performance deficiency material to an ITAAC was entered into the licensees corrective action program. For each construction inspection finding determined to be an ITAAC Finding, the staff verified through subsequent inspection that the licensee adequately corrected the condition before closing the ITAAC Finding or verified that the ITAAC Finding was being addressed by the licensees ITAAC maintenance program and that the issue did not cross an ITAAC maintenance threshold requiring notification to the NRC.

Construction inspection findings were evaluated for significance in accordance with IMC 2519, Construction Significance Determination Process, and were assigned a color representing the significance of the finding. The color thresholds for the construction significance determination process (SDP) were risk informed through the assignment of systems and structures by an expert panel to columns in the construction SDP matrix based on risk achievement worth values and other risk importance considerations. In addition, color thresholds were based on a qualitative measure of construction quality, which was defined through expert staff judgment. A description of each color threshold is as follows:

(3) Red (high safety or security significance) qualitatively indicates a decline in licensee performance that is associated with unacceptable quality of construction that provides no assurance that the plant is being constructed in accordance with its design in the area(s) associated with the finding.

(4) Yellow (substantial safety or security significance) qualitatively, indicates a decline in licensee performance that is still acceptable with cROP cornerstone objectives met, but with significant reduction in the assurance that the plant is being constructed in accordance with its design in the area(s) associated with the finding.

(5) White (low to moderate safety or security significance) qualitatively indicates an acceptable level of performance by the licensee, but outside the nominal risk range. Cornerstone objectives are met with minimal reduction in assurance that the plant is being constructed in accordance with its design in the area(s) associated with the finding.

(6) Green (very low safety or security significance) qualitatively indicates that licensee performance is acceptable and cornerstone objectives are fully met.

Acceptable licensee corrective actions for these issues provide assurance that C-13

the plant is being constructed in accordance with its design in the area(s) associated with the finding.

In accordance with guidance in IMC 2505, the staff considered the safety significance of the construction inspection findings to assess the licensees level of safety performance within each of the six cornerstones of safety associated with the strategic performance areas (Figure 2) defined in IMC 2506 and IMC 2200, Security Program for Construction.

The staff also inspected the licensees construction programs pursuant to IMC 2504.

Inspection of the construction programs indirectly evaluated the licensees ITAAC performance because these programs affect the quality of the SSCs that are the subject of the ITAAC. Areas of inspection included the licensees ITAAC management program, QA activities affecting SSCs, reporting of defects and noncompliances, fitness for duty, and the preoperational testing program. In addition to the construction programs, the staff also inspected the licensees operational programs in accordance with IMC 2504.

A fundamental goal of the NRCs oversight of construction activities was to establish confidence that the licensee (and its contractors) were detecting and correcting problems in a manner that ensured quality and safety were paramount and that construction activities were completed in a manner that ensured the facility was constructed in accordance with the design and would operate safely. A key premise of the NRCs oversight process is that weaknesses in a licensees corrective action program would manifest themselves as performance issues that would be identified during the NRCs inspection program.

The NRC accomplished these objectives through (1) routine resident inspector reviews of corrective action program issues, (2) inspection samples during each inspection, (3) follow-up on selected NRC-identified issues, and (4) periodic team inspections in accordance with IP 35007, Quality Assurance Program Implementation During Construction and Pre-Construction Activities. Additionally, the adequacy of the licensees corrective action program was assessed during each end-of-cycle review throughout the construction of the facility.

The NRCs construction inspection reports for [plant name] are listed in Attachment 1.

The reports are available in ADAMS and may be accessed from the links provided in the attachment.

During performance of the CIP, the NRC identified [XXX] construction inspection findings for [plant name]. Of these, [XXX] were identified as ITAAC Findings and [XXX] were Construction Findings. For each ITAAC Finding, the staff, through subsequent inspection, verified that any deficient conditions material to the acceptance criteria were corrected or that the ITAAC Finding was being addressed in the licensees ITAAC maintenance program and that the issue did not cross an ITAAC maintenance threshold requiring notification to the NRC. [Add discussion of construction inspection findings commensurate with the significance of the findings. For example, if all findings are Green, the following discussion would be sufficient: In addition, all construction inspection findings were Green (very low safety or security significance) and qualitatively C-14

indicate that the licensees performance was acceptable and all cornerstone objectives were fully met.]

The corrective actions taken by the licensee for the ITAAC Findings provide assurance that the plant was constructed in accordance with its design in the area(s) associated with the finding. Summaries of the ITAAC findings may be accessed via the NRC Web site [insert Web link]. Attachment 4 lists all the ITAAC findings for [plant name] and provides Web links to the associated inspection reports.

4.3 Reactor Construction Assessment The cROP integrated the NRCs inspection, assessment, and enforcement programs to allow the staff to evaluate the overall performance and safety culture of [licensee name]

and to communicate this information to licensee management, and except for certain security-related information, to members of the public and other stakeholders. Per IMC 2505, [licensee name] performance was reviewed throughout construction on a routine basis, quarterly, and every 12 months.

The Reactor Construction Assessment Program used the information from NRC inspections of selected construction activities and programs, NRC enforcement actions, allegations, and NRC safety culture assessments to arrive at an objective integrated assessment of the safety performance of [licensee name]. Based on this assessment information, the NRC determined the appropriate level of its response, such as performing supplemental inspections, conducting meetings with NRC and licensee management, or other responses as described in the IMC 2505 Construction Action Matrix (CAM).

The CAM (Figure 3) lists expected NRC and licensee actions based on the inputs to the assessment process and the licensees placement into one of the following CAM columns.

  • Licensee Response Column (Column 1)
  • Regulatory Response Column (Column 2)
  • Degraded Performance Column (Column 3)
  • Multiple/Repetitive Degraded Cornerstone Column (Column 4)
  • Unacceptable Performance Column (Column 5)

Actions are graded such that the agency becomes more engaged as licensee performance declines.

Additionally, the NRC identified cross-cutting issues to inform the licensee if the agency had a concern with the licensees performance in the cross-cutting area and to encourage the licensee to take appropriate actions before more significant performance issues emerged. The cross-cutting aspects are described in IMC 0613, Power Reactor Construction Inspection Reports, Appendix F, Construction Cross-Cutting Areas and Aspects. Cross-cutting aspects are assigned, and cross-cutting issues are identified on a per site basis, not on a per unit basis. Construction cross-cutting themes include the following:

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  • human performance
  • problem identification and resolution
  • safety-conscious work environment Performance outside of the licensee response band is subject to plant-specific supplemental inspections based on the assessed performance. The depth and breadth of specific supplemental inspections depend on the significance of the identified issues.

In addition, the staff conducts reactive inspections in response to nonperformance events and issues that occur at the facility.

The NRCs Plant Assessment Letters for [plant name] are available from the links provided in Attachment 2.

[Add discussion of plant assessment letters commensurate with the NRCs assessment of licensee performance. For example, if all cornerstone objectives are met and all inspection findings are Green, the following discussion would be sufficient: Throughout the construction period, the NRC determined that overall, the licensee constructed the facility in a manner that preserved public health and safety and met all cornerstone objectives. Licensee performance remained within the Licensee Response Column of the NRCs Construction Reactor Oversight Process (cROP) Action Matrix throughout construction because all inspection findings had very low (i.e., Green) safety significance.]

4.4 Vendor Inspection Program The vendor inspection staff implemented the vendor inspection program at vendor facilities where basic components for [plant name] were designed, manufactured, or stored. IMC 2507, Vendor Inspections, provides guidance for the inspection and assessment of QA programs, detailed design and manufacturing activities, and implementation of the requirements of 10 CFR Part 21, Reporting of Defects and Noncompliance, in support of operating and new reactor licensing, as well as construction activities. Specifically, IMC-2507 defines the vendor inspection program for the following activities:

  • Inspections of vendor QA program implementation during design and procurement activities in support of material, equipment, and services supplied to the commercial nuclear industry.
  • Inspections to assess whether the vendor QA programs address specific processes such as commercial-grade dedication practices, vendor and subvendor oversight, and reporting of defects and noncompliance associated with safety-related components or services used in a nuclear power plant in accordance with 10 CFR Part 21 or 10 CFR 50.55(e) as applicable.
  • Inspection to assess whether the vendor QA program implementation during design, fabrication, and testing of basic components supports ITAAC-related activities such as inspection of offsite fabrication, modular construction techniques, equipment qualification, and fabrication of long-lead components.

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  • Inspections to verify that root cause analyses of reported defects and failures to comply are being identified and that suitable corrective actions are developed and implemented.
  • Provision of input to the NRC operating experience program to give timely information to the nuclear industry of potential issues that are safety significant and have generic implications. These issues could include substandard, suspected counterfeit, or fraudulently marked basic components.

Performance of ITAAC at vendor facilities remains the ultimate responsibility of the licensee. The licensees must therefore address the ITAAC findings identified during a vendor inspection in its ICNs. However, vendor findings are not treated in the same manner as those identified under the CIP. Specifically, vendor findings are not evaluated via the SDP or considered in the licensee plant assessment process.

The NRCs reports for its vendor inspections are publicly available at [insert link]. The vendor inspection reports specifically related to ITAAC for [plant name] are listed in Attachment 3, which provides links to the associated inspection reports.

For each ITAAC finding identified at a vendor facility, the vendor corrected the issue, and the NRC performed either a subsequent onsite inspection or an in-office review of the vendors corrective actions before closing the ITAAC finding.

The ITAAC findings related to [plant name] that were identified during vendor inspections at a vendor facility are listed in Attachment 4 along with links to the associated inspection reports.

[If necessary, insert paragraph to further discuss documentation of vendor ITAAC findings.]

5.0 Conclusion As discussed above, the NRC implemented systematic processes for reviewing licensee ITAAC notifications, inspecting licensee and vendor activities related to ITAAC, and assessing licensee performance. Based on the results of these processes, the staff has determined that all acceptance criteria in the [plant name] combined license [license #]

are met.

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Figure 1 ITAAC Matrix (A) (B) (C) (D) (E) (F)

As-Built Welding Construction Operational Qualification Design and Inspection Testing Testing Criteria Fabrication Requirement (01) Foundations & Buildings A01 B01 C01 D01 E01 F01 (02) Structural Concrete A02 B02 C02 D02 E03 F02 (03) Piping A03 B03 C03 D03 E03 F03 (04) Pipe Support & Restraints A04 B04 C04 D04 E04 F04 (05) Reactor Pressure Vessel A05 B05 C05 D05 E05 F05

& Internals (06) Mechanical Components A06 B06 C06 D06 E06 F06 (07) Valves A07 B07 C07 D07 E07 F07 (08) Electrical Components &

A08 B08 C08 D08 E08 F08 Systems (09) Electrical Cables A09 B09 C09 D09 E09 F09 (10) Instrumentation & Control A10 B10 C10 D10 E10 F10 Components & Systems (11) Containment Integrity &

A11 B11 C11 D11 E11 F11 Penetrations (12) Heating Ventilation and Air Conditioning A12 B12 C12 D12 E12 F12 (HVAC)

(13) Equipment Handling &

A13 B13 C13 D13 E13 F13 Fuel Racks (14) Complex Systems with A14 B14 C14 D14 E14 F14 Multiple Components (15) Fire Protection A15 B15 C15 D15 E15 F15 (16) Engineering A16 B16 C16 D16 E16 F16 (17) Security A17 B17 C17 D17 E17 F17 (18) Emergency A18 B18 C18 D18 E18 F18 Preparedness (19) Radiation Protection A19 B19 C19 D19 E19 F19 C-18

Figure 2 C-19

Figure 3 Cross-Cutting Areas Construction Action Matrix Multiple/Repetitive Degraded Licensee Response Regulatory Response Degraded Performance Unacceptable Performance Cornerstone (Column 1) (Column 2) (Column 3) (Column 5)

(Column 4)

All inspection findings Green; One or two White findings in a One degraded cornerstone (three Repetitive degraded cornerstone, multiple Overall unacceptable cornerstone objectives fully strategic performance area; white findings or one yellow finding) degraded cornerstones, multiple yellow performance; construction RESULTS met cornerstone objectives met with or any three white findings in a findings, or one red finding; cornerstone suspended in the area of concern minimal degradation in safety strategic performance area; objectives met with longstanding issues or performance cornerstone objectives met with significant degradation in safety moderate degradation in safety performance performance Regulatory None BC or DD meet with RA/DRAC (or designee) meet with EDO/DEDO (or designee) meet with EDO/DEDO (or designee) meet with Performance licensee senior licensee management senior licensee management senior licensee management Meeting Licensee Licensee corrective action Licensee root cause evaluation and Licensee cumulative root cause Licensee performance improvement plan Licensee performance improvement Action corrective action with NRC evaluation with NRC oversight with NRC oversight plan/construction restart plan with oversight NRC oversight

RESPONSE

NRC Risk-informed baseline Baseline and supplemental Baseline and supplemental Baseline and supplemental IP 90003, Baseline and supplemental as Inspection inspection program IP 90001, Construction Regulatory IP 90002, Construction Degraded Construction Supplemental Inspection for practicable, plus special inspections Response Column Inspections Performance Column Inspections Repetitive Degraded Cornerstones, per construction restart checklist Multiple Degraded Cornerstones, Multiple Yellow Inputs or One Red Input Regulatory None Supplemental inspection only Supplemental inspection only - 10 CFR 2.204 DFI Order to modify, suspend, or revoke Actions1 Plant discussed at AARM if - 10 CFR 50.54(f) letter licensed activities.

conditions met - CAL/order Plant discussed at AARM Plant discussed at AARM Assessment BC or DD review/sign DD review/sign assessment letter DRAC review/sign assessment letter RA review/sign assessment letter (with RA review/sign assessment letter Letters assessment letter (with (with inspection plan) (with inspection plan) inspection plan) (with inspection plan) inspection plan)

COMMUNICATION Public Various public stakeholder Various public stakeholder options RA/DRAC (or designee) discuss EDO/DEDO (or designee) discuss EDO/DEDO (or designee) discuss Stakeholders options (see Section 12) (see Section 12) involving the BC performance with senior licensee performance with senior licensee performance with senior licensee involving the SRI or BC or DD management management management External None State Governors State Governors, DHS, State Governors, DHS, Congress State Governors, DHS, Congress Stakeholders2 Congress 1 Other than the CAL, the regulatory actions for plants in Column 4 are not mandatory NRC actions. However, the regional office should consider each of these regulatory actions when significant new information regarding licensee performance becomes available.

2 These specific stakeholders shall be notified if a plant is moving to the specified column because of security-related issues.

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Multiple/Repetitive Degraded Licensee Response Regulatory Response Degraded Performance Unacceptable Performance Cornerstone (Column 1) (Column 2) (Column 3) (Column 5)

(Column 4)

Commission None None Possible Commission meeting if Commission meeting with senior licensee Commission meeting with senior Involvement licensee remains for 11/2 years management within 6 months3 licensee management INCREASING SAFETY SIGNIFICANCE 3 The timing of the meeting shall be based on a collegial determination by the Commission informed by a recommendation from the Executive Director of Operations (EDO) and may exceed the 6-month requirement.

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Table 1 Inspection Procedures 65001 Inspections of Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC)

Related Work 65001.01 Inspection of ITAAC-Related Foundations and Buildings 65001.02 Inspection of ITAAC-Related Installation of Structural Concrete 65001.03 Inspection of ITAAC-Related Installation of Piping 65001.04 Inspection of ITAAC-Related Installation of Pipe Supports and Restraints 65001.05 Inspection of ITAAC-Related Installation of Reactor Pressure Vessel and Internals 65001.06 Inspection of ITAAC-Related Installation of Mechanical Components 65001.07 Inspection of ITAAC-Related Installation of Valves 65001.08 Inspection of ITAAC-Related Installation of Electrical Components and Systems 65001.09 Inspection of ITAAC-Related Installation of Electric and Fiber Optic Cable 65001.10 Inspection of ITAAC-Related Installation of Instrument Components and Systems 65001.11 Construction Inspection Program Inspection of ITAAC-Related Containment Integrity & Containment Penetrations 65001.12 Inspection of ITAAC-Related Installation of Heating, Ventilating, and Air Conditioning Systems 65001.13 Inspection of ITAAC-Related Installation of Load Handling Equipment and Fuel Racks 65001.14 Inspection of ITAAC-Related Installation of Complex Systems with Multiple Components 65001.15 Inspection of ITAAC-Related Installation of Fire Protection Equipment 65001.16 Inspection of ITAAC-Related Engineering 65001.17 Inspection of ITAAC-Related Security Structures, Systems, and Components 65001.18 Inspection of Emergency Planning ITAAC 65001.19 Inspection of Installation of ITAAC-Related Radiation Monitoring Components and Systems 65001.20 Inspection of Safety-Related Piping DAC-Related ITAAC 65001.21 Inspection of Pipe Rupture Hazard Analysis Design Acceptance Criteria (DAC)

Related ITAAC 65001.22 Inspection of Digital Instrumentation and Control (DI&C) System/Software Design Acceptance Criteria (DAC)Related to ITAAC 65001.23 Inspection of Human Factors Engineering Integrated System Validation ITAAC C-22

65001.A Inspection of the As-Built Attributes for Structures, Systems, and Components (SSCs) Associated with ITAAC 65001.B Inspection of the ITAAC-Related Welding Program 65001.C Inspection of the ITAAC-Related Construction Test Program 65001.D Inspection of the ITAAC-Related Operational Testing Program 65001.E Inspection of the ITAAC-Related Qualification Program 65001.F Inspection of the ITAAC-Related Design and Fabrication Requirements C-23

Attachment 1 Construction Inspection Reports Date ML# Subject Related Correspondence C-24

Attachment 2 Plant Assessment Letters Date ML# Subject Related Correspondence C-25

Attachment 3 Vendor Inspection Reports Date ML# Subject Related Correspondence C-26

Attachment 4 ITAAC Findings ITAAC FindingsConstruction Inspection Finding Number Title Inspection IR ML #

Report (IR) Closed ML #

Opened ITAAC Findings Vendor Inspection Finding Number Title IR ML # IR ML #

Opened Closed C-27

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