ML20283A183

LIC-117 Acceptance Review Process for New Nuclear Facility Licensing Applications Supporting Guidance Document - Cola Acceptance Review Guide

ML20283A183
Person / Time
Issue date:	01/22/2021
From:	Allen Fetter, David Williams NRC/NRR/DANU/UARL, NRC/NRR/DNRL/NRLB
To:
Williams D. DANU, Fetter A. DNRL
Shared Package
ML20283A182	List: ML20283A183 ML20283A185 ML20283A188
References
LIC-117
Download: ML20283A183 (12)

Text

Safety Analysis Report Acceptance Review Guide for Combined License (COL) Applications

Background Information This Review Guide is intended to be used by the technical branches to perform their acceptance reviews of a COL application. The findings of the acceptance review will be provided to the Lead Project Manager (PM) so they can evaluate completeness, technical sufficiency and the impacts of the technical issues identified during this review on the generic schedule. This review guide contains Table 1, Safety Analysis Report Acceptance Review Results Table, which is organized by review area(s)/topic(s) within assigned safety evaluation report (SER) sections.

For a COL application, 10 CFR 2.101(a)(5) allows the application to be submitted in two parts.

One part shall be accompanied by the information required by 52.80, Contents of applications; additional technical information, paragraph (b). The other part shall include the information required by 52.79, Contents of applications; technical information in final safety analysis report, and 52.80(a). Whichever part is filed first shall also include the information required by 10 CFR 52.79(a)(1), 50.33, Contents of applications; general information, and 50.37, Agreement limiting access to Classified Information. One part may precede or follow other parts by no longer than 6 months. Each part of the tendered application will receive an acceptance review and can be docketed.

For COL applications referencing a design that is either already certified or being reviewed for certification, the staff developed a design-centered-review approach (DCRA).4 With the DCRA, staff decisions made on the reference COL (RCOL) would apply to all subsequent COLs (SCOL)." Therefore, during performance of an acceptance review of an SCOL application, the staff is expected to verify the degree of standardization to the RCOL but focus its review on site-specific and application-specific issues.

Prior to the acceptance review, the PMs and technical reviewers should be familiar with:

• The anticipated scope of review of the COL application including the following:

o Assigned COL application section(s) and relevant supplemental information (e.g., Technical or Topical Reports), departures from the Design Control Document (DCD), Design Acceptance Criteria (DAC) and/or Inspection, Test, Analysis and Acceptance Criteria (ITAAC).

o Design-specific finality matrices (compilation of COL information items, action items, and other COL issues) have been prepared for reference by staff reviewing COL applications referencing the DCD. This information is available within the project specific integrated workspace.

o RG 1.206 contains the expected information for a COL application referencing a Design Certification (DC).

o Corresponding section(s) of the standard review plan (SRP) or Design Specific Review Standard (DSRS).

o A list of Safety Analysis Report (SAR) review areas that can potentially involve a more detailed review (Agencywide Documents Access and Management System

[ADAMS] Accession No. ML072430683). This list does not replace the SRP, but rather represents a list of review areas contained within the SRP that may potentially involve more detailed technical review (e.g., involve computer code evaluation, detailed data analysis, new safety feature, or emerging operating experience).

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o The design-centered-review approach (DCRA),1 such that staff decisions made on the reference COL would apply to all subsequent COLs.

o Concurrent reviews (e.g., DC application review, DC amendment review. For a subsequent COL application, review the reference COL application, and/or related topical report reviews).

o Available risk insights applicable to COL application sections under review.

• The review schedule and estimated staff-hours.

The following directions should be used by PMs and technical staff in performing the acceptance review. Table 1 should be used to document the acceptance review effort. The information in this table may be used to evaluate the acceptability of the COL application for docketing. Each branch may choose to make entries for each review area or SRP section in Table 1.

Alternatively, a branch may choose to enter information only for those technical areas that are 1

Additional information on DCRA is provided in SECY-06-0019, dated January 31, 2006.

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found to be incomplete, not technically sufficient or those areas that will require changes to resource planning assumptions.

I. Completeness Review: Verify that the COL application contains all of the information required by the applicable regulations for your assigned review(s), as discussed in Section 3.3.2 of the office instruction. If the COL applicant uses the statement that a review topic is incorporated by reference (IBR) to the DC, this statement constitutes a complete response relative to the COL application section (and therefore no technical sufficiency review will be required for that section). In addition, the COL applicant should explain how it addressed any COL information items addressing plant-specific information. Then begin completing Table 1 as appropriate.

A. Document the review area(s)/topic(s) in Column 1 (List all review topics or only those found to be not complete or not technically sufficient).

B. Determine whether the applicant has addressed the applicable regulations for the assigned review area. See RG 1.206 for the COL application acceptance review checklist. [yes/no in Column 2]

10 CFR 52.79 Contents of applications; technical information in final safety analysis report, identifies prescriptive requirements for the contents of a COL application. These requirements are captured in the RG 1.206 checklist.

However, 52.79 also contains cross-cutting requirements. For the following cross-cutting requirements, determine if any apply to your review section(s). For those in your review area, determine if the applicant addressed the proper items.

The applicants compliance with these requirements should be provided in Chapter 1 of the Final Safety Analysis Report (FSAR):

1. Three Mile Island requirements [10 CFR 52.79(a)(17)];

2. Proposed technical resolutions of unresolved safety issues and medium-and high-priority generic safety issues [10 CFR 52.79(a)(20)];

3. Introduction of new safety features [10 CFR 52.79(a)(24)];

4. Operating experience insights incorporated into the plant design [10 CFR 52.79(a)(37)];

5. Conformance with SRP/DSRS [10 CFR 52.79(a)(41)].

Additional cross-cutting requirements specifically related to information required for a COL application referencing a DC include:

1. Demonstration that the site characteristics fall within the site parameters specified in the design certification [10 CFR 52.79(d)(1)] (summarized in Chapter 2 of the FSAR);

2. Demonstration that interface requirements have been met [10 CFR 52.79(d)(2)];

3. Demonstration of all requirements and restrictions set forth in the referenced design certification rule, other than those imposed under

§50.36b, must be satisfied by the date of issuance of the COL [10 CFR 52.79(d)(3)] - (this includes addressing COL information items, COL action items, identified departures from the certified design, and replacement of DC conceptual design information with site specific design details).

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C. For each review area/topic not addressed, summarize deficiency in Column 5, and promptly notify the Lead PM if RSIs are needed.

II. Technical Sufficiency Review: Identify significant technical deficiencies in the COL application associated with your assigned review using the attached table and the following guidelines. The information contained in the various parts of the COL application that are discussed above in the Background Information should also be considered. A technical deficiency is defined as missing, improper, inadequate, or incorrect technical information needed by the NRC staff to conduct the assigned review.

A significant technical deficiency is missing information that results in the staff being unable to conduct its review of the application against the acceptance criteria in the SRP/DSRS or conduct its review within a predictable timeframe. If a significant technical deficiency is identified, the application should not be docketed unless it is able to be addressed through RSIs. Minor technical deficiencies by contrast should be able to be addressed within reasonable rounds of RAIs and without notably impacting the overall schedule for the COL application.

Additional consideration should be given to any review areas/topics contained in the Safety Analysis Report Acceptance Review List that could require more extensive review time than is reflected in the generic review schedule.

As noted in Section 3.3.2, of the office instruction risk insights may be available during the acceptance review. If so, these insights should be used to help determine the depth of the technical sufficiency review. If a review area/topic is associated with a risk-significant SSC, indicate a yes in Column 6, in the attached table.

For the determined scope of technical sufficiency review:

A. Document additional review areas/topics in Column 1, as needed.

B. Determine whether the COL application section(s) is(are) sufficient to conduct the detailed technical review for the review areas/topics identified in Column 1 [yes/no in Column 3].

C. Determine whether the review areas/topics identified in Column 1 can be resolved through the RSI or RAI process [yes/no in Column 4].

D. Document the technical deficiency (ies) that could prevent you from conducting your detailed technical review in Column 5. Describe the basis (es) for the deficiencies. These review area/topics may involve a significant amount of time to address (e.g., development of computer codes or first-of-a-kind testing) and estimate how this could impact the overall review schedule for your COL application section.

E. Notify the Lead PM of significant deficiencies and the need of RSIs as soon as they are identified.

F. Determine whether the identified technical deficiency is related to a risk-significant SSC [yes/no in Column 6].

III. Changes to Planning Assumptions:

Augmenting Planned Resources (Staff-Hours):

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Re-evaluate the total review time that will be needed to conduct a review based on the significant technical deficiencies or new, unplanned review items documented in the Table 1. The acceptance review allows the reviewer to identify potential changes from the generic review schedule and estimated staff-hours so that an application-specific review schedule can be modified, if necessary. The following characteristics of a COL application may require additional review time:

A. departures from the DCD; B. inclusion or reference to new safety features; C. alternative approaches to SRP acceptance criteria (including alternatives to regulatory guides);

D. instances of a site characteristic falling outside of design parameters; E. for a subsequent COL, differences from the reference COL; or F. other miscellaneous review topics that have not been adequately represented within the pre-baseline model, (e.g., replacement of DC conceptual design information with site specific design details and other COL supplemental information, new operating experience and regulations since DCD or RCOL issuance).

Next, determine whether the review effort is reflected within the pre-baseline model (e.g., the estimated staff-hours are sufficient to perform the review of the departure?)

[yes/no in Column 7]. For each no in table, identify the change to the staff-hour planning assumptions and provide a basis (e.g., departure not addressed in pre-baseline review schedule) in Column 8. Identify the projected review time in staff-hours needed to address all of the applicable items above for your COL application section. This can be for the total review time and does not have to be on an individual review area/topic.

Reducing or Eliminating Planned Resources (Staff-Hours):

Some SRP sections may be completely IBR, where all design features in the DC are referenced with no change or further information. For this case the estimated staff-review hours for Phases 1 and 4 should be zero, and Phase 2 should be minimal to account for administrative production of the SER input. Note, the administrative production of the SER input for complete IBR may become a projects function with overall SER chapter concurrence by the technical staff. If the pre-baseline model identified staff review hours then the responsible branch should answer no for Column 7 in Table 1 and provide the following basis for eliminating the staff-hours required - complete IBR.

Some SRP sections may be a partial IBR, where design features are adopted from the DC into the COL FSAR and the applicant has provided some design specific information such as COL action items. The responsible branch then needs to adjust the pre-baseline model commensurate with the scope of review and answer no for Column 7 in Table 1.

For each no in the table, identify the change to the staff-hour planning assumptions and provide a basis (e.g., limited review not reflected in generic review schedule) in Column

8. Identify the projected review time in staff-hours needed to address all of the applicable items above for your COL application section.

As with augmenting staff-hours, reducing staff-hours can be for the total review time and does not have to be on an individual review area/topic basic, but the branch chief and Lead PM need to be informed if schedule changes are needed.

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IV. Identification of Dependencies between Concurrent Reviews: Identify any known dependencies between concurrent reviews. These dependencies could be between a DC review and a concurrent COL review (e.g., EPR DCD review concurrent with the EPR RCOL review), or there could be dependencies between reference COLs and subsequent COLs. These dependencies could potentially result in changes to planning assumptions.

For example, the staff-hours associated with the review of a topical or technical report may be captured separate from the baseline review schedule. Those hours should not be double counted in related reviews. However, this does not change the duration of the task.

A. Identify and document review dependencies in Table 1(Columns 10 and 11).

Special Cases For a Combined License (COL) Application referencing a Design Certification (DC) that has not been certified (e.g., reviewed concurrently)

Generally, 10 CFR 52.55(c) states, An applicant for a construction permit or combined license may, at its own risk, reference in its application a design for which a design certification has been docketed but not granted. Following this requirement, there would likely be a minimum 60-day lag between the submittal of a DC application and a COL application referencing the DC since the target timeframe of the expanded DC acceptance review is 60 days1.

In addition to the above:

1. The staff performing the COL acceptance review should treat a section or portion of a section IBR to the Design Control Document as complete and technically sufficient, as long as, the scope of information to be addressed within the COL application is complete (anticipated contents are identified in Section C.III.1, Information Needed for a Combined License Application Referencing a Certified Design). Missing, incomplete, or technically insufficient information should be addressed consistent with guidance within this office instruction, that is, should be documented as incomplete in Table 1.

The staff can assume that the COL review and the DC review will proceed in parallel, and that issues within the DC review will be resolved within the DC review and COL issues will be resolved within the COL review. The information IBR must become certified before the COL can be issued. Furthermore, an open item will be added to the COL safety evaluation report (SER) with open items related to the need for the COL applicant to supplement the COL application as necessary to address resolution of issues in the DC.

1 If the COL application precedes docketing of the DC application, then the schedule for the respective acceptance reviews will be determined on a case-by-case basis (e.g., Bellefonte COL application referencing proposed Revision 16 to the AP1000 Design Control Document). The acceptance reviews may be done in series, in parallel or as a combined review. Things to consider in the conduct of these reviews: efficiency, effectiveness, and complexity of the technical issues. While the acceptance review schedule(s) will be developed on a case-by-case basis, it is important to note that the Commission direction in COMDEK-07-0001/COMJSM-07-0001 prescribed the expanded acceptance review to be 60 days.

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2. Section 3.3.5, Review schedules are dependent on/driven by the progress and completion of the DC review - not the target schedule of 30-months for a COL referencing a certified DC - Any delays in the DC schedule will automatically impact the COL schedule.

3. With respect to the concurrent reviews, the identification of certain challenging DC review areas that may impact the COL review schedule may necessitate that the NRC recommend deferral of the COL review on that topic until after the issue is resolved within the DC. The dependencies/deferral of certain review areas are reserved for those areas in which the resolution of the DC issue will cause significant rework during the COL after the issue is resolved.

For a Combined License (COL) Application referencing a Design Certification (DC) that has not been certified (e.g., reviewed concurrently) and which also references an Early Site Permit (ESP)

The only difference from the previous case is the additional requirements of 52.79 related to referencing an ESP as summarized below.

1. The Final Safety Analysis Report (FSAR) should include or incorporate by reference the approved ESP. Further, the FSAR should establish the design of the facility falls within the site characteristics and design parameters specified in the ESP.

2. If the final safety analysis report does not demonstrate that design of the facility falls within the site characteristics and design parameters, the application shall include a request for a variance that complies with the requirements of §§ 52.39 and 52.93. This might require additional staff-hours beyond the baseline estimates.

3. The FSAR must demonstrate that all terms and conditions that have been included in the ESP, other than those imposed under § 50.36b, will be satisfied by the date of issuance of the combined license. If any of these terms or conditions are found to be left out of the FSAR, then the staff should document this as missing information in Table 1.

4. Evaluate for completeness and technical adequacy any updates or revisions to the approved emergency plans in the ESP. If complete and integrated emergency plans were approved as part of the referenced ESP, new certifications meeting the requirements of 10 CFR 52.79(a)(22) are not required and this could result in a reduction of expected staff-hours.

For a Subsequent Combined License (SCOL) Application referencing a Design Certification The primary difference between the acceptance review for an SCOL application and a reference combined license (RCOL) application is that in addition to the site-specific portions of the review, the staff verifies the degree of standardization of the SCOL application to that of the RCOL. The site-specific portions of the application are treated the same as that of a RCOL.

As it relates to the design-center-review approach (DCRA), standard information relates to information incorporated by reference (IBR) to a design certification or information that is not IBR but identical to the RCOL. For SCOL application acceptance reviews, staff verifies standard 8

information is identical to that in the RCOL. In addition, the reviewer should be familiar with sections of the application which may interface with their assigned section of the application for review (as may be defined in related SRP section) to ensure any review issues within those sections would not impact the standardization determination. If the section is standard, Table 1 could be excluded and the generic review schedule should be completed to reflect the assigned FSAR sections will not need technical staff resources in review Phases 1 and 2. Note that the SER inputs for completely standard sections in a SCOL SER will be developed by project staff and concurred in by the technical staff during the advanced final SER.

If the FSAR section contains site-specific information or through the acceptance review it is determined that the application is not completely standard to the RCOL, then the staff should follow the guidance for a COL application referencing a Design DC that has not been certified to capture the non-standard review areas that will require staff review effort. The staff should also update the staff effort if it differs from the adjusted baseline estimates on Table 1 and the generic review schedule.

Similar to the parallel review of an RCOL and DC, an SCOL review can proceed in parallel with the RCOL review and issues within the RCOL review will be resolved within the RCOL review and SCOL issues will be resolved within the SCOL review. The information identified as standard is to be approved in the RCOL before the SCOL is issued. Furthermore, an open item will be added to the SCOL SER describing the need for the SCOL applicant to supplement its COL application as necessary to address resolution of issues in the RCOL. For both complete and partially standard sections, review Phase 4 will be when the applicant addresses this open Item, and the staff will re-verify the standard designation. This becomes a mini-acceptance review. The review effort for new site-specific information will be assessed for schedule and resource impacts when the application is revised.

NOTE: A 4-phase review schedule will be developed for the review of a SCOL application. The 4-phase review schedule removes the SER with open items. The total duration remains at about 30 months. After the conversion, assigned staff will have the opportunity to make adjustments to the baseline schedule.

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Table 1: Safety Analysis Report Acceptance Review Results for [Applicant Name] [Design Center Name] [Application Type]2 SAR Section: Technical Branch : (Primary/Secondary) Technical Reviewer:

Branch Chief: SRP Section: Date:

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Are there any technical deficiencies, changes in planning assumptions, or dependencies on concurrent reviews? Yes/No, Identify specific review area/topic in table below.

Changes to Planning Assumptions to Completeness and Technical Sufficiency Which be Considered in Development of the Review Dependencies Among Concurrent Reviews Form Basis for Acceptability for Docketing Review Schedule

6. Is the identified technical deficiency related to a

10. Can the review of the area/topic be completed

9. Identify the total review time in staff-hours*****

4. Can the technical deficiency be resolved

2. Does COL section address the items required

3. Is COL section technically sufficient for this 7. Are the pre-baseline review schedule and

5. If no, for either completeness through the RSI or RAI process within a without the completion of a concurrent review?

1. Review or technical

8. For each no, Area/Topic* sufficiency, identify the change (+ 11. For each no, identify which application identify risk-significant SSC)? (yes/no)****

or -) and basis for (DCD or COLA) and section.

by regulation (refer to RG 1.206)? (Yes/No) deficiency (ies).

review area/ topic? (yes/no)**

change.

estimated staff-hours appropriate? (yes/no)

This information predictable timeframe? (yes/no)***

will be needed (yes/no) for technical review.

RSI RAI

• Review Area/Topic: Item identified in RG 1.206 or the regulations; for a COL application referencing a DC, this includes COL information items and departures from the design certification.

• • Technical Sufficiency: The application is compared against the SRP acceptance criteria. Note: New safety features, alternate regulatory compliance approaches, and/or departures and exemptions from DCs, should not be treated as deficiencies and factored into the basis for rejecting the application, unless staff determines that there is insufficient technical information associated with the respective item. These items are factored into confirmation of planning assumptions.

• • • Significant deficiencies are those review area/topic which impact the staffs ability to conduct the detailed technical review or complete its review within a predictable timeframe.

• • • • Division of Safety Systems & Risk Assessment will provide risk significance information at time of review, if available.

• • • • • Identification of new review time is on a FSAR section basis and consistent with the review phases within the generic review schedule. Changes from the generic review schedule and estimated hours should be on that basis.

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2 NOTE: Branches may use this form to make entries for all review area/topics; or alternatively, to make entries only for those areas that have issues with completeness, sufficiency, or those that require changes (+ or -) to baseline estimated staff-hours.

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