ML051930012

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Table - Comments/Suggestions Regarding NEI 04-01
ML051930012
Person / Time
Site: Nuclear Energy Institute
Issue date: 07/18/2005
From: Joseph Colaccino
NRC/NRR/DRIP/RNRP
To:
Nuclear Energy Institute
Colaccino,Joseph,NRR/DRIP/RNRP,415-2753
Shared Package
ML051930006 List:
References
NEI 04-01
Download: ML051930012 (26)


Text

Comments/Suggestions Regarding NEI 04-01 Enclosure Chapter/

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Proposed Change 1

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General Comments: This report is distinguished by a number of positive aspects, which include:

1. Recommendation of full-scope combined operating license (COL) PRAs covering full power and shutdown modes of operation.
2. Compliance with consensus PRA quality standards, available at the time of PRA development or updates.
3. Phased updating of the design-certification PRA at the time of COLA, before plant startup, and following plant startup by maintaining the plant-specific PRA and periodically updating it during the plant lifetime (even though the updating frequency was not addressed).

NEI 04-01 is focused only on advanced light-water reactor (ALWR) designs, other non-light-water reactor advanced designs are not considered in the report. Section 4.3.9.19 has heavy reliance upon AP1000 information. It is true that the AP1000 design control document (DCD) represents the most recent NRC-reviewed ALWR PRA information. However, DCD COL items differ from one certified ALWR design to another (e.g., ABWR, System 80+, etc.).

Examples of differences need to be discussed in this chapter, or in attachments to the report.

AP1000 tables in Chapter 19 do not seem to recognize the phased approach to PRA updates mentioned later in the report (e.g., Section 4.4). Even though COLA items cannot be completely resolved at the COLA stage, some items can be partially resolved, using the available site-specific, as well as the engineering drawings for the as-to-be-built plant.

Supplemental guidance is needed on how the applicant will identify changes applicable to the COLA PRA update, separate from those changes relevant to phase 2 (i.e., as-built, as-to-be-operated). This guidance will assure consistency with Section 4.4 guidance.

Furthermore, in the area of external events, the report should encourage the use of PRA techniques as opposed to margins-type approaches (e.g., SMA) or vulnerability screening approaches (e.g., fire-induced vulnerability evaluation). PRA techniques should be relied upon more during the COLA, pre-operational, and operational phases. (Note that Draft Fire PRA Methodology Standard, BSR/ANS 58.23 was issued on May 9, 2005.)

It is also noted that the report has no guidance or criteria for identification of changes to be considered in PRA updates (or screened out of consideration). The staff is generally uncomfortable with the notion that some design changes may be screened out of Friday, July 08, 2005 Page 1 of 26 ADAMS Accession No. ML

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Proposed Change consideration in PRA updates. We would expect that the final PRA (after plant startup) would reflect the as-built, as-operated plant without exception. Therefore, the concept of screening should be replaced with the concept of deferring. Since the staff, Advisory Committee on Reactor Safeguards (ACRS), and Commission have previously indicated their position that the PRA should be used as a design aid (during the evolution of the standard certified design into the final as-built, as-operated plant), the proper question is how to decide when (not if) plant changes should be evaluated using PRA. Obviously, some changes may have a major impact on the risk results and should be evaluated without delay. Other changes will have only a small or negligible impact, and their incorporation into the PRA may be deferred to a final PRA update. Development of specific guidelines or criteria will reduce reliance on judgment, and its consequential variability, and add consistency to the PRA update process.

Finally, the results of fire and flooding walkdowns can be important to realistic PRA updates.

Unlike seismic walkdowns for which detailed guidance exists, fire and flooding do not have detailed walkdown guidance. Development and incorporation of this guidance are essential.

4.3.4 4.3.4-7 S

25 Last sentence states that, FSAR [final safety analysis report] information addressing COL items should be consistent with the level of detail of related information in the generic DCD and that provided in recent FSARs. This is not appropriate for two reasons:

The lack of detail in the related area of the generic DCD is one possible reason for the COL item.

There are no recent FSARs for new plants. And FSARs for existing plants do not address all of the items that new plants must address and which are the subject of several COL items, e.g., NUREG-0711.

4.3.4 4.3.4-6 S

25 Paragraph 1: Third sentence states that information addressing COL [combined licensed]

Items is by definition beyond the scope of the design certification. This is not in the definition of COL items in Part 52, App. C, II.E.4 for AP600 (or similar sections for the ABWR or CE-80+). Nor is it in Definition 2.3 of NEI 04-01. Thus, the by definition portion of the sentence should be deleted. Further, Definition 2.3 is the same as Part 52 except that it uses the term COL Information Items while Part 52 uses the term COL action items. The definition should agree with Part 52.

4.3.4 4.3.4-5 S

25 Paragraph 1: First sentence: Should state, in the generic DCD [design control document] and SER [safety evaluation report].

Friday, July 08, 2005 Page 2 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.4 4.3.4-9 S

26 Third sentence: States that, Such deviations from COL items are not subject to change control... specified in Sections VIII and X... Please clarify why that is the case when COL items are Tier 2, and Tier 2 is covered by Change Control in Section VIII of the design certification rule.

4.3.4 4.3.4-8 S

26 Second full sentence: Add to the end of the sentence the part shown here:...provided the applicant justifies the departure (or omission) in the FSAR. The reason for this suggestion is that Part 52, App. C.II.E.4 requires that this justification be in the FSAR.

4.3.9.1.1 4.3.9.1.1-1 S

33 States that, Generic DCDs contain the required comparisons with similar plants. These comparisons are adequate for purposes of a COL application and need not be updated or supplemented by the COL applicant. Please clarify why this information need not be updated.

4.3.9.3 4.3.9.3-3 S

64 Table 4.3.9.3-1, Item 3-15: The guidance currently states that The COL applicant will evaluate deviations from the design due to as-procured or as-built conditions and will summarize the results of the evaluation in an as-built summary report as described in Subsections 3.8.3.5.7, 3.8.4.5.3, and 3.8.5.4.2. At the COL application stage (i.e., with the plant not yet built), the COL applicant will not be able to identify and evaluate deviations from the design due to as-procured and as-built conditions. Rather, the applicant should describe in its COL application the contents of the report used to summarize deviations between the AP1000 DCD and the as-procured and as-built conditions. This item also references ASME Section III Code Case-284, which is listed in RG 1.193 as unacceptable. It also lists fuel load as the completion time. The guidance should be revised to indicate that deviations from the certified design should be identified as soon as possible (e.g., at COL application) and no later than fuel load.

4.3.9.3 4.3.9.3-4 S

65 Table 4.3.9.3-1, Item 3-19: The guidance currently states that The COL referencing the AP1000 design will develop a program to verify operability of essential snubbers as outlined in Subsection 3.9.3.4.3. This item should reference Subsection ISTD of the OM Code.

Adherence to NUREG-0800, Sections 3.9.2 and 3.9.3 should result in the COL application containing snubber test information similar to that contained in current operating plant FSARs Friday, July 08, 2005 Page 3 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.3 4.3.9.3-5 S

65 Revise the guidance as indicated: (Delete: COL applicants referencing the AP1000 design will develop an inservice test program in conformance with the valve inservice test requirements outlined in subsection 3.9.6 and Table 3.9-16. A preservice test program, which identifies the required functional testing, is to be submitted to the NRC. The IST program will include provisions for nonintrusive check valve testing methods and the program for valve disassembly and inspection outlined in subsection 3.9.6.2.3. The COL applicant will complete an evaluation as identified in subsection 3.9.6.2.2 to demonstrate that power-operated valves with low differential pressure have adequate margin and operability testing of these valves is not required.)

Replace with: At the COL application stage:

Assess whether the Inservice Test Program for pumps and valves will meet the Tier 2 requirements specified in Section 3.9.6 of the AP1000 Design Control Document and report any potential deviations to the NRC. Certify that the design will provide (a) access and (b) component and system configuration to enable the performance of inservice testing; and that (c) that the scope of components to be tested conforms with applicable ASME Code requirements; and (d) that the methods used to perform inservice tests conform with applicable ASME Code requirements. [The staff would anticipate that the plant design would facilitate compliance with Code requirements without the need for relief from those requirements based on impracticality.] Specifically, the COL applicant must confirm that (criteria for pump and valve testing as specified in SECY-90-016 and the AP1000 Design Certification SER):

- Piping design will incorporate provisions for full-flow testing at maximum design flow of pumps and check valves

- Check valve testing will incorporate the use of advanced nonintrusive techniques to address degradation and performance characteristics

- Provisions will be established to determine the frequency necessary for disassembly and inspection of pumps and valves to detect unacceptable degradation not detectable through the use of advanced nonintrusive techniques

- Provisions will be incorporated to test motor-operated valves (MOVs) under design-basis differential pressure.

Identify any expected requests for relief,* proposed alternative requirements, and Code cases that will be needed or used based on editions and addenda of the ASME Code that is incorporated by reference in paragraph (b) of 10 CFR 50.55a in effect at the time of the application subject to the limitations and modifications listed in the regulation. Staff review Friday, July 08, 2005 Page 4 of 26 ADAMS Accession No. ML

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Proposed Change would be documented in the COL FSER. Provide detailed request for approval of alternatives to ASME Code requirements.

Adherence to NUREG-0800, Sections 3.9.6, 5.2.1.2, 5.2.4, 6.6 and Table 3.9-16 should result in the COL application containing IST Program information similar to that contained in current operating plant FSARs.

Within 6 months of fuel load:

The COL holder provides to the NRC for review and approval comprehensive plant-specific inservice testing program based on editions and addenda of the ASME Code that is incorporated by reference in paragraph (b) of 10 CFR 50.55a in effect 12 months before fuel load subject to the limitations and modifications listed in the regulation. Certify that the Inservice Test Program for pumps and valves meets the Tier 2 requirements specified in Sections 3.9.6 and 3.9.8.4 of the AP1000 Design Control Document and report any deviations from those requirements. The comprehensive plant-specific IST program should specify:

- Design, scope, and test methods (evaluated on a sample basis)

- Relief requests and alternatives previously granted and authorized by the NRC at the COL application stage.

- Any additional relief requests and requests for authorization of alternatives (each specifically reviewed by the NRC).

Specifically, the comprehensive plant-specific IST program should include the following items (as specified in the AP1000 Design Certification SER):

- tests performed on each component and the Code requirement met by each test

- test parameters and frequency of the tests

- normal, safety, and fail-safe position on each valve

- component type for each component

- P&ID coordinates for each component Any compliance issues arising from program review will be resolved with the COL holder in regulatory or enforcement space, as appropriate.

Acceptability of requests for relief and approval of alternatives along with results of sample-based review of the comprehensive plant-specific IST program would be documented in an NRC safety evaluation.

Adequate implementation of the comprehensive plant-specific IST program (i.e.,

Friday, July 08, 2005 Page 5 of 26 ADAMS Accession No. ML

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Proposed Change compliance with FSAR and approved program) will be verified by NRC inspection. This inspection(s) will be an part of the NRCs Operational Readiness Assessment performed prior to the Commissions §52.103(g) finding (Fuel Load).

  • Because of changes that may occur in ASME Code requirements between the Code editions and addenda in effect at the time of the design certification application and the version of the Code in effect at the time of the COL application, the potential exists for the need for relief requests.

Friday, July 08, 2005 Page 6 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.3 4.3.9.3-6 S

69 The COL applicant should summarize in the COL application, how it intends to satisfy the Tier 1 Inspection, Test, Analysis, and Acceptance Criteria (ITAAC) for valves as specified in the System Based Design Description of the AP1000 Design Control Document (DCD).

The COL applicant should be responsible for developing a preservice test program that confirms the adequacy of pump and valve design. Compliance with GDC 1, GDC 37, GDC 46, as well as ASME OM Code requirements and adherence to NUREG-0800, Sections 3.9.2, 5.2.1.1, 14.2, and RG 1.68, Initial Test Programs for Water-Cooled Nuclear Power Plants, should result in the COL application containing dynamic test information similar to that contained in current operating plant FSARs.

As stated in RG 1.68, the primary objectives of an acceptable initial or startup test program are (1) to provide assurance through testing that the facility has been adequately designed, (2) to validate, to the extent practical, the analytical models and verify the correctness or conservatism of assumptions used to predict plant responses to anticipated transients and postulated accidents, (3) to provide assurance through testing that construction and installation of equipment in the facility have been accomplished in accordance with the design, (4) to familiarize the plants operating staff with the operation of the facility, and (5) to verify by trial use, to the extent practical, the adequacy of the facilitys operating procedures and emergency operating procedures.

For each phase of the initial test program, the COL applicant should provide test abstracts which include the objectives of each test, a summary of the prerequisites and test methods, and specific acceptance criteria. Conformance of the proposed test program to the guidelines of RG 1.68 and the acceptance criteria outlined in SRP Section 14.2 provide reasonable assurance it meets these objectives. Initial test programs that satisfy these objectives should provide the necessary assurance that the facility can be operated in accordance with its design criteria and in a manner that will not endanger the health and safety of the public.

A preservice (PST) and startup test program for pumps and valves, which satisfies the aforementioned objectives, is to be submitted to the NRC by the COL applicant prior to performing the tests and following the start of construction.

The COL applicant is responsible for providing test specifications and test procedures for the preoperational and startup tests, as identified in [DCD Tier 2, Section] 14.2.3. [This is COL Action Item 14.4-2.]

The COL applicant is responsible for a startup administration manual (procedure) which contains the administration procedures and requirements that govern the activities associated with the plant initial test program, as identified in [DCD Tier 2, Section] 14.2.3 for Friday, July 08, 2005 Page 7 of 26 ADAMS Accession No. ML

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Proposed Change review by the NRC. [This is COL Action Item 14.4-3.]

The COL applicant and holder is responsible for the review and evaluation of individual test results. Test exceptions or results which do not meet acceptance criteria are identified to the affected and responsible design organizations, and corrective actions and retests, as required, are performed. In as much as test results will not be available until the facility is built, the NRC staff determined that it is appropriate and acceptable to defer the review and evaluation of individual test results to the COL applicant or holder, as appropriate. [This is COL Action Item 14.4-4.] The COL applicant or holder should have the test result available on site for inspection by the NRC staff on or before commercial operation.

The COL applicant or holder is responsible for ensuring the operability of active valves consistent with section 3.9.3.2.2 of the AP1000 DCD. The COL applicant should commit to valve testing as described in this section. The COL applicant will complete an evaluation as identified in Subsection 3.9.6.2.2 of the AP1000 DCD to demonstrate that power-operated valves with low differential pressure have adequate margin and operability testing of these valves is not required.

4.3.9.12.2 4.3.9.12.2-2 C

121 The Comment section for Item 12-4 in Table 4.3.9.12-1 states that the licensee will make procedures (used for adequate radiological protection) available in the COLA [combined license application] by the time of fuel load. It is the staffs position that various procedures and organizational structures will have to be implemented at different times as the radiological conditions of the plant under construction change. These various times could include when radiological sources are first brought on site, when reactor fuel is brought on site, at the time of fuel load, and when the plant goes critical.

The word radiological under the Description section for Item 12-4 in Table 4.3.9.12-1 is misspelled.

4.3.9.12.2 4.3.9.12.2-1 C

122 After reviewing the section entitled Example Health Physics Program Description provided on pages 122-131, the staff found this section to be unacceptable. The section did not contain sufficient information or the level of detail needed to adequately describe a licensees health physics program as it should be described in a combined license application. The staff suggested holding a series of meetings with NEI representatives responsible for providing input to NEI 04-01 Section 4.3.9.12. The staff has met several times with the NEI task force on this issue since mid-March. The NEI task force is scheduled to provide a revised draft of this section to the NRC prior to our next meeting with NEI on June 13, 2005.

The staff may have additional comments and questions once we review NEIs revised draft of Section 4.3.9.12.

4.3.9.13.1 4.3.9.13.1-2 S

133 Table 4.3.9.13-1: Table 4.3.9.13-1 should include AP1000 in the title to ensure it is clear that it is an AP1000 example and not generic information.

Friday, July 08, 2005 Page 8 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.13.2 4.3.9.13.2-2 S

136 Paragraph 1: States, The type and extent of program description should be consistent with that contained in recent FSARs. This may not be an appropriate criterion since there are no recent FSARs for new plants; and USARs for existing plants may not fully address all of the items that new plants must address and which are in the SRP, Chapter 13.0.

Friday, July 08, 2005 Page 9 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.14 4.3.9.14-2 S

143 Table 14.3.9.14.1, Item 14-2: The COL applicant should summarize in the COL application, how it intends to satisfy the Tier 1 Inspection, Test, Analysis, and Acceptance Criteria (ITAAC) for valves as specified in the System Based Design Description of the AP1000 Design Control Document (DCD).

The COL applicant should be responsible for developing a preservice test program that confirms the adequacy of pump and valve design. Compliance with GDC 1, GDC 37, GDC 46, as well as ASME OM Code requirements and adherence to NUREG-0800, Sections 3.9.2, 5.2.1.1, 14.2, and RG 1.68, Initial Test Programs for Water-Cooled Nuclear Power Plants, should result in the COL application containing dynamic test information similar to that contained in current operating plant FSARs.

As stated in RG 1.68, the primary objectives of an acceptable initial or startup test program are (1) to provide assurance through testing that the facility has been adequately designed, (2) to validate, to the extent practical, the analytical models and verify the correctness or conservatism of assumptions used to predict plant responses to anticipated transients and postulated accidents, (3) to provide assurance through testing that construction and installation of equipment in the facility have been accomplished in accordance with the design, (4) to familiarize the plants operating staff with the operation of the facility, and (5) to verify by trial use, to the extent practical, the adequacy of the facilitys operating procedures and emergency operating procedures.

For each phase of the initial test program, the COL applicant should provide test abstracts which include the objectives of each test, a summary of the prerequisites and test methods, and specific acceptance criteria. Conformance of the proposed test program to the guidelines of RG 1.68 and the acceptance criteria outlined in SRP Section 14.2 provide reasonable assurance it meets these objectives. Initial test programs that satisfy these objectives should provide the necessary assurance that the facility can be operated in accordance with its design criteria and in a manner that will not endanger the health and safety of the public.

A preservice (PST) and startup test program for pumps and valves, which satisfies the aforementioned objectives, is to be submitted to the NRC by the COL applicant prior to performing the tests and following the start of construction.

The COL applicant is responsible for providing test specifications and test procedures for the preoperational and startup tests, as identified in [DCD Tier 2, Section] 14.2.3. [This is COL Action Item 14.4-2.]

The COL applicant is responsible for a startup administration manual (procedure) which contains the administration procedures and requirements that govern the activities Friday, July 08, 2005 Page 10 of 26 ADAMS Accession No. ML

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Proposed Change associated with the plant initial test program, as identified in [DCD Tier 2, Section] 14.2.3 for review by the NRC. [This is COL Action Item 14.4-3.]

The COL applicant and holder is responsible for the review and evaluation of individual test results. Test exceptions or results which do not meet acceptance criteria are identified to the affected and responsible design organizations, and corrective actions and retests, as required, are performed. In as much as test results will not be available until the facility is built, the NRC staff determined that it is appropriate and acceptable to defer the review and evaluation of individual test results to the COL applicant or holder, as appropriate. [This is COL Action Item 14.4-4.] The COL applicant or holder should have the test result available on site for inspection by the NRC staff on or before commercial operation.

The COL applicant or holder is responsible for ensuring the operability of active valves consistent with section 3.9.3.2.2 of the AP1000 DCD. The COL applicant should commit to valve testing as described in this section. The COL applicant will complete an evaluation as identified in Subsection 3.9.6.2.2 of the AP1000 DCD to demonstrate that power-operated valves with low differential pressure have adequate margin and operability testing of these valves is not required.

Friday, July 08, 2005 Page 11 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.14 4.3.9.14-3 S

146 Table 14.3.9.14.1, Item 14-7: The COL applicant should summarize in the COL application, how it intends to satisfy the Tier 1 Inspection, Test, Analysis, and Acceptance Criteria (ITAAC) for valves as specified in the System Based Design Description of the AP1000 Design Control Document (DCD).

The COL applicant should be responsible for developing a preservice test program that confirms the adequacy of pump and valve design. Compliance with GDC 1, GDC 37, GDC 46, as well as ASME OM Code requirements and adherence to NUREG-0800, Sections 3.9.2, 5.2.1.1, 14.2, and RG 1.68, Initial Test Programs for Water-Cooled Nuclear Power Plants, should result in the COL application containing dynamic test information similar to that contained in current operating plant FSARs.

As stated in RG 1.68, the primary objectives of an acceptable initial or startup test program are (1) to provide assurance through testing that the facility has been adequately designed, (2) to validate, to the extent practical, the analytical models and verify the correctness or conservatism of assumptions used to predict plant responses to anticipated transients and postulated accidents, (3) to provide assurance through testing that construction and installation of equipment in the facility have been accomplished in accordance with the design, (4) to familiarize the plants operating staff with the operation of the facility, and (5) to verify by trial use, to the extent practical, the adequacy of the facilitys operating procedures and emergency operating procedures.

For each phase of the initial test program, the COL applicant should provide test abstracts which include the objectives of each test, a summary of the prerequisites and test methods, and specific acceptance criteria. Conformance of the proposed test program to the guidelines of RG 1.68 and the acceptance criteria outlined in SRP Section 14.2 provide reasonable assurance it meets these objectives. Initial test programs that satisfy these objectives should provide the necessary assurance that the facility can be operated in accordance with its design criteria and in a manner that will not endanger the health and safety of the public.

A preservice (PST) and startup test program for pumps and valves, which satisfies the aforementioned objectives, is to be submitted to the NRC by the COL applicant prior to performing the tests and following the start of construction.

The COL applicant is responsible for providing test specifications and test procedures for the preoperational and startup tests, as identified in [DCD Tier 2, Section] 14.2.3. [This is COL Action Item 14.4-2.]

The COL applicant is responsible for a startup administration manual (procedure) which contains the administration procedures and requirements that govern the activities Friday, July 08, 2005 Page 12 of 26 ADAMS Accession No. ML

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Proposed Change associated with the plant initial test program, as identified in [DCD Tier 2, Section] 14.2.3 for review by the NRC. [This is COL Action Item 14.4-3.]

The COL applicant and holder is responsible for the review and evaluation of individual test results. Test exceptions or results which do not meet acceptance criteria are identified to the affected and responsible design organizations, and corrective actions and retests, as required, are performed. In as much as test results will not be available until the facility is built, the NRC staff determined that it is appropriate and acceptable to defer the review and evaluation of individual test results to the COL applicant or holder, as appropriate. [This is COL Action Item 14.4-4.] The COL applicant or holder should have the test result available on site for inspection by the NRC staff on or before commercial operation.

The COL applicant or holder is responsible for ensuring the operability of active valves consistent with section 3.9.3.2.2 of the AP1000 DCD. The COL applicant should commit to valve testing as described in this section. The COL applicant will complete an evaluation as identified in Subsection 3.9.6.2.2 of the AP1000 DCD to demonstrate that power-operated valves with low differential pressure have adequate margin and operability testing of these valves is not required.

4.3.9.16.1 4.3.9.16.1-1 S

175 Section IV, Additional Requirements and Restrictions. Requires COL applicant to include,

.PSTS [plant-specific technical specifications] consisting of the generic and site-specific TS, that are required by 10 CFR 50.36 and 50.36a. 10 CFR 50.36a TS are not specified in operating reactor TS (Appendix A to the license) or in Improved Standard Technical Specifications (NUREGs 1431-1434). How are effluent TS per 50.36a incorporated into the COL application?

4.3.9.16.1 4.3.9.16.1-2 S

175 Section VIII, Processes for Changes and Departures, each Design Certification Rule indicates (in Item C.4) that an applicant who references the rule may request an exemption from the generic TS or other operational requirements.

Guidance is needed to establish a threshold for TS changes that require an exemption request. Specific directions should be given if TS and Bases processes are different.

4.3.9.16.2 4.3.9.16.2-1 S

177 COL Item 16.1-1; PS DCD Section 16.2.1.1, The set of TS is intended to be used as a guide on the development of the PSTS. COLA referencing AP1000 will replace preliminary information provided in brackets with final plant information Provide guidance for getting staff acceptance of proposed information in brackets.

Pre-COL Staff SE and Hearing; Post-COL 50.90 Friday, July 08, 2005 Page 13 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.16.2 4.3.9.16.2-2 S

178 Bullet #1:...Appendices E and F for the AP1000and ABWR (respectively) contain examples of GTS that do not reflect the DCD ITAAC, COL items, interface requirements and TS identified in the text.

This instruction is a subset of Table 4.3.9.16-1 (page 176) Item No. 16.1 (replace information in [ ] ).

4.3.9.16.2 4.3.9.16.2-3 S

178 Bullet #2:...identify inconsistencies (with ITS Writers Guide) and recommend revisions to correct the errors.

Identify the process during COL application and after COL issuance for incorporating inconsistencies.

4.3.9.16.2 4.3.9.16.2-4 S

178 Bullet #3:.... review Bases application of the 10 CFR 50.36 Criteria....TS for SSC not credited in the safety evaluation should be reconsidered...

This guidance may be in error..... In the BWR ITS, RCIC is retained in TS based on Criterion 4; however, RCIC is not credited in the safety analysis. A reevaluation would change the acceptance criteria for ECCS-Operating TS Completion Times in the current STS.

Guidance in the example is in error: The AP1000 containment air filtration system (VRS) is not assumed to mitigate a DBA (Fuel Handling Accident) and should not be required. The VRS regulatory requirement basis is defense in depth and are in the current STS.

4.3.9.16.2 4.3.9.16.2-5 S

179 Bullet #1: For regulations, e.g., 10 CFR 50.59, evaluate impact of the changes and recommend revisions to make the references correct. For guidance documents, e.g., RG 1.52, evaluate impact and recommend whether new guidance should be applied.

Identify the process for incorporating changes/recommendations.

Pre-COL Staff SE and Hearing; Post-COL 50.90 Friday, July 08, 2005 Page 14 of 26 ADAMS Accession No. ML

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Proposed Change 4.3.9.16.2 4.3.9.16.2-6 S

179 Bullet #2: identify TSTFs that correct an error or provide significant improvement (e.g., risk-based relaxation) for adoption.

Some TS requirements, including some in the Administrative Controls Section, may be relocated to licensee-controlled documents, such as the COLR or PTLR. However, the information normally found in these documents should be submitted as part of the application.

Provide criteria for identifying TSTFs that correct an error. It would also be appropriate to state that approved TSTFs can be adopted on a plant-specific basis and to instruct the COL applicant that some TSTFs, such as applications for risk-informed TSTFs may require additional supporting analysis and information to be submitted to meet staff requirements for the proposed TS. The need for additional information is usually stated in the SE (and model application for a CLIIP TSTF) for the TSTF. Note that SEs may not be available for TSTFs prior to about 2003.

COL applicants must perform a review of generic letters and bulletins issued since the design certification to determine where additional changes to the TS are required. Examples include GL-2004-01, Requirements for Steam Generator Tube Inspections, and GL-2005-XX which refers to model TS for Steam Generators found in TSTF-449. A summary of the applicability should be included in the COL Application. The staff may modify or supplement the TS in accordance with VIII.C.3.

4.3.9.16.2 4.3.9.16.2-7 S

180 Paragraph 2: Also, along with the COLA (not as part of the application), it is appropriate to include a marked-up version of the GTS and GTS Bases to assist the staff in determining the differences and to facilitate review discussions.

COL applications need to assess the significance of information that is submitted but is not part of the application.

4.3.9.16.2 4.3.9.16.2-8 S

180 Paragraph 3: Thus, all changes should be identified in the justification document as belonging to one of the following classes.

At the March meeting, the staff had discussions with NEI about which Generic TS information is considered completely reviewed and approved, and which is not. NEI should clarify its position with the staff before finalizing the COL applicant guidance document Section 4.3.9.16.

4.3.9.16.2 4.3.9.16.2-9 C

180 Paragraph 4: such a filing, i.e., at a date later than the COLA filing,....

The COL applicant needs to factor in the Technical Specification review effort when deciding on the timing of the application. The staff needs at least one year prior to operating to review the changes to PSTS.

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Proposed Change 4.3.9.16.6 4.3.9.16.6-1 C

182 As required by 10 CFR 50.36 and 50.36a, this chapter incorporates (by reference) the proposed technical specifications in accordance with the requirements of sections 50.36 and 50.36a for operating power reactors.

Delete the phrase As required by 10 CFR 50.36 and 50.36a. This is not an accurate statement, because the content of FSAR Chapter 16 is based on the Standard Review Plan guidance, not regulations.

4.3.9.18 4.3.9.18-2 S

195 Suggest deleting the term Main Control Room from the title as it may mislead COLs on the scope of the NRCs HFE [human factors engineering] review. The scope of NUREG-0711 HFE reviews is broader than just the MCR. The scope is clearly identified in Section 2, HFE PROGRAM MANAGEMENT, Subsection 2.4.1, General HFE Program Goals and Scope:

(3) Applicable Facilities - The HFE program should address the main control room, remote shutdown facility, technical support center (TSC), emergency operations facility (EOF), and local control stations (LCSs).

The staffs determination of what HSIs [human-system interfaces] to consider relate to their safety importance and not where the HSIs are located. Thus, recommend deleting this part of the title.

4.3.9.18 4.3.9.18-3 S

195 Paragraph 3: States that, The 12 elements of the HFE Program Review Model are reviewed in Design Certification. To avoid any confusion, the NEI document should note that the different design certification reviews were not all completed using the same version of NUREG-0711. Only the AP1000 review was completed using the NUREG-0711, Revision 1.

Further, there is no list of references in the NEI document. A reference list should be added and it should include the latest version of NUREG-0711, which is Revision 2.

4.3.9.18 4.3.9.18-4 S

195 Paragraph 6: States While based on the AP1000, it is expected that this guidance will be readily adaptable by COL applicants who reference another standard design for which certification was based on use of similar HFE DAC/ITAAC. This assumption may not hold.

The different design certification reviews used different versions of NUREG-0711 and each design was in different stages of completion.

4.3.9.18 4.3.9.18-5 S

195 Paragraph 1: First paragraph emphasizes HSI design as the focus of HFE. The staffs HFE review, as defined in Chapter 18 of the SRP and NUREG-0711, encompasses more than HSI design. The paragraph should be changed to reflect the broader scope of HFE.

4.3.9.18 4.3.9.18-6 S

195 Paragraph 6: Please explain the assertion that the guidance will be readily adaptable by COL applicants who reference another standard design... For example, how will the guidance be used by an applicant who may reference a GE ABWR design given that the HFE program for that design was less complete than the AP-1000 and the guidance used by the staff to review the design was somewhat different?

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Proposed Change 4.3.9.18 4.3.9.18-1 S

195 General Comment: The AP1000 COL items, design commitments and DAC/ITAAC are quite different from the ABWR and System 80+ material. They were reviewed against different versions of NUREG-0711 and were at different stages of completion. If so, the guidance provided may only apply to AP1000. This should be clarified.

4.3.9.18.1 4.3.9.18.1-1 S

196 COL Item 18.2-1: Each of the subsections of the COL guidance, A, B, and C, identify the HSI design as the main focus of the HFE program. For example, The HFE Program Plan should focus on integrating HFE with the HSI design process... NUREG 0711 describes the HFE activities the staff will review in support of the design of HSIs, procedures, and training programs. Specifically, in Section 2, HFE PROGRAM MANAGEMENT, Subsection 2.4.1, General HFE Program Goals and Scope, states:

(4) Applicable HSIs, Procedures and Training - The applicable HSIs, procedures, and training included in the HFE program should include all operations, accident management, maintenance, test, inspection and surveillance interfaces (including procedures). Thus, it is recommended that the wording be modified accordingly.

The guidance should be modified to reflect this scope.

4.3.9.18.1 4.3.9.18.1-2 C

197 COL Item 18.2-2: Item B states The commitment that the EOF [emergency operations facility] be designed in accordance with the [AP1000] HFE program should be limited to the HSI that are available in the EOF (as designed through the HSI Design Process). There should be no unique task analysis, anthropometric analyses, verification and validation, etc.

performed for the EOF as it is not a facility allowing operation of the power plant (such as the Main Control Room or Remote Shutdown Room). However, the FSER stipulates that, the

[EOF] presentation of the plant data should be consistent with the HSI design (COL Action Item 18.2.3.1-1). Important activities and decisions occur in the EOF. It should designed in accordance with the approved HFE program as specified in the COL Item and in NUREG-0711. This commitment should not be limited as stated in NEI 04-01. The task analyses, design and controls may be different than for the main control room.

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Proposed Change 4.3.9.18.2 4.3.9.18.2-1 S

198 Paragraph 3: The NEI guideline states that, The COL Applicant, as a nuclear utility, is required to have either an in-house program or access to industry programs (e.g., through INPO) that gather and disseminate operating experience to existing plants. Operating experience since 1996 relevant to HSI design should be sorted and provided to the ongoing HSI design process. The COL Applicants SAR should indicate how this supplemental input is provided to and addressed by (e.g., formally responded to) the vendor. The continuous impact of new experience on completed design work must be strictly limited to critical concerns.

The staff agrees with this guidance; however, the review of experience should not be limited to HSIs but should include any HFE-related experience of operating plants of the same (or similar) type. A COL may be initiating this process after considerable experience has become available. If a COL references an ABWR design, in 2010, many years of ABWR operating experience will be available while there was none available at the time of ABWR design certification. This same situation may be true for any referenced design, depending on the time of the COLA. Thus it is important that the COL demonstrate knowledge of relevant operating experience of similar advanced plants that are operational at the time.

4.3.9.18.2 4.3.9.18.2-2 S

199 Top paragraph, last sentence: Please clarify the following guidance: The continuous impact of new experience on completed design work must be strictly limited to critical concerns.

What are critical concerns? Where is the term defined? Who makes the determination of what constitutes a critical concern. Additionally, the limitation to critical concerns may to too restrictive for all COL cases. For example, a MCR design may be quite far along at the time of COLA submittal and in such a case limiting the late changes to the design to only the more important ones makes good sense. However, in other cases, the MCR design may not have progressed much beyond that available during the design certification. In such a case, if tie has passed and there is new pertinent OE, then it should be considered as the MCR design is being developed.

4.3.9.18.3 4.3.9.18.3-1 S

199 Paragraph 2: Regarding function analysis and allocation, the COL guidance states No additional work is required for COL application, no further submittals are necessary.

However, note that in Section 18.4.4 Conclusions of the AP1000 SER one of the bases for closing this element was that, The applicant discussed a detailed analysis of functional requirements and allocation, and has identified a process to further evaluate allocation if necessary. The need for and use of this process should be clarified in the guidance.

4.3.9.18.4 4.3.9.18.4-1 S

199 Paragraph 1: In the guidance the reference to task analysis is to the Westinghouse-specific methodology that uses Function-based Task Analysis and Operational Sequence Analysis.

The literature on task analysis is replete with methods/approaches to accomplish the objectives of task analysis. The generic COL guidance should not specify a particular methodology. However, if the FBTA/OSA is to be used as an example, it should be identified as such.

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Proposed Change 4.3.9.18.4 4.3.9.18.4-2 C

200 Paragraphs A and B under COL Application Guidance indicate that the FBTA and OSA-1 should be completed by the time of COL application. Under ITAAC, the statement is made that, ITAAC for those task analysis activities that will not be completed before COL application submittal should be retained. We understand that the potential for this type of partial early ITAAC closure is under discussion with the staff. This will need to be updated based on methods agreed upon for this activity.

4.3.9.18.6 4.3.9.18.6-1 S

202 COL Item 18.7-1: (human reliability analysis/human factors engineering integration implementation plan), the document states that, The HRA input to the HSI design process, staffing, training and procedure development should be complete and review of these items should be completed by the time of COL application. Validation of the HRA operator performance assumptions will be completed as part of the Integrated HFE System Validation. The review of the results of this effort will require a narrowly focused ITAAC.

Based on discussion at the 6/09/05 meeting, NEI stated this would be deleted.

4.3.9.18.6 4.3.9.18.6-2 S

203 COL Item 18.7-1: The ITAAC guidance states that, Design commitment #1 in Table 3.2-1 of the DCD should be revised to focus on completion of the validation of operator performance assumptions regarding risk important tasks as part of the Integrated HFE System Validation.

The current Design Commitments should be completed by the time of COL application.

The design commitment/ITAAC are acceptable and appropriate as written and should not be revised. This was a part of the technical basis for the staffs safety finding. As discussed in the AP1000 FSER Section 18.7.4, the critical and risk important actions should be appropriately addressed in the design of the plant, including in the HSIs, procedures, shift staffing, and training, in order to provide minimize the likelihood of personnel error and to provide for error detection and recovery capability. The intent of the COL action item is to ensure that these activities are completed.

4.3.9.18.8 4.3.9.18.8-1 S

206 Paragraphs 3 & 4: Regarding COL Applicant Guidance on computerized procedures, the document states: Comparative performance of CPS and paper versions - In the AP1000 FSER (pp. 18-66 to 67), the staff indicated that simulated operations using the CPS should reflect that they are a net improvement over the paper-based equivalent if electronic procedures are to be used in preference to paper. NUREG-0711 Rev.2 indicates that the use of electronic rather than paper procedures should be justified and documented (review criterion 9.4(7) on p.45). Given the well-known obstacles to effective performance measurement, a very cautious approach to defining measures and acceptance criteria for this exercise is recommended. The exercise should be performed as early as possible, since design feedback may result, and the results should be resolved prior to HFE V&V (18.11). (p. 204). Please clarify the comments regarding well-known obstacles to effective performance measurement.

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Proposed Change 4.3.9.18.8 4.3.9.18.8-2 S

206 Paragraph 4: Guidance on computerized procedures, the document states, The option to design and build a CPS was allowed on the assumption that paper-based procedures, in general, remain a viable option. However, the proposed fall back to paper (FSAR p.18-67) was not clearly a reference to real-time operation. It is the staffs position that use of a CPS would be based on the availability of a paper-based backup for real-time operation. Both NUREG-0711 and NUREG-0700 are clear that real time back up is expected. NUREG-0711, Procedure Development Review Criterion 7 states that, An analysis of alternatives in the event of loss of CBPs should be performed and documented. NUREG-0700 Guideline 8.5-1, Paper-Based Procedure Availability, states that, PBPs should be available in the event of CBP failure.

The guideline further states, As a result, the maintenance of full sets of paper procedures may or may not be required. Other real-time options are possible (e.g., if common-mode failure of CPS occurs, use the safety console and a simple paper procedure to perform safe shutdown.). As part of COL application, it is necessary to evaluate the reliability of CPS and the limitations imposed by its loss, and to state what steps will be taken in response. (p.

204). In line with the comment in NEI 04-01, the backup paper procedures may not necessarily need to be as comprehensive and detailed as current paper procedures, since they could primarily be used for safe shutdown in the event of loss of CBPs. The staff agrees that a complete set of paper-based procedures for all computerized procedures may not be necessary. Instead, the decision of how to handle CBP loss should be part of a larger concept of operations for degraded condition. That is, the staff expects that the COL will evaluate the conditions of degraded and lost I&C, including the CPS, and develop a comprehensive operational strategy for handling these events. Paper-based backup procedures should be consistent with the selected approach to managing conditions of degraded or lost I&C and HSIs, considering such a loss in coincident with a major plant disturbance that would have operators in EOPs.

4.3.9.18.10 4.3.9.18.10-2 S

208 Last paragraph: Regarding COL guidance for integrated system validation, the document states, The plan for integrated system validation should include objective and scope, description of required facilities, identification of plant personnel requirements, identification and definition of operational scenarios, acceptance criteria and documentation requirements.

(p. 206). As per NUREG-0711, the plan should also address performance measurement, test design, and data analysis.

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Proposed Change 4.3.9.18.10 4.3.9.18.10-1 C

208 Paragraph 4: Regarding COL guidance for preparing a V&V plan addressing Design Commitment # 4, the document states A comprehensive HFE V&V Implementation plan should be developed documenting an acceptable plan for conducting the HFE V&V. The plan should include the following activities (1) HSI Task Support Verification, (2) HFE Design Verification, (3) Integrated System Validation and (4) Human Engineering Discrepancy (HED)

Resolution. The COL guidance provided addresses only part of Design Commitment # 4.

The guidance does not address Issue Resolution Verification or Plant HFE/HSI Verification.

The COL guidance should address the full scope of the design commitment. Alternatively, these two verifications can be addressed as part of Design Implementation as they currently are in NUREG-0711 (see section on Design Implementation following.)

4.3.9.18.11 4.3.9.18.11-2 C

209 Paragraph 3: The ITAAC states, Table 3.2-1 Design Commitment #5a in the AP1000 DCD contains ITAAC for issue resolution verification. This ITAAC presumably will not be completed prior to COL application.

The reference should be changed to Design Commitment #5d. Further, Plant HFE/HSI Verification can not be completed prior to COL application since it require that the plant be built and ready to operate. And while most of the issues should be resolved, Issue Resolution Verification is also likely to have some remaining issues to be addressed at that time.

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Proposed Change 4.3.9.18.11 4.3.9.18.11-1 C

209 Paragraph 1: As per the statement of Design Certification Completion Level the document states, This process element applies primarily to plant modernization and was not addressed in Design Certification. However, that is not accurate. There are review criteria in this element that apply to new plants. The criteria address the resolution and closure of HFE issues in the issues tracking system, prior to fuel load. This was formerly addressed as V&V item.

Further, the COL Applicant Guidance states, The Combined License applicant should not need to do any additional work in this area and no submittal should be required. However, the system/process for tracking and resolving HFE issues on the facility should be in service at this time. It is important that this system/process include reliable mechanisms to ensure that each HFE issue on the facility design is resolved. Resolution of the issues is confirmed by an ITAAC. NUREG-0711 states, For both new and modified designs, it is important to determine that the design that is implemented (i.e., the "as-built" design) accurately reflects the verified and validated design. Guidance on this aspect should be provided.

By way of clarification, on Revision 2 of NUREG-0711, Issue Resolution Verification or Plant HFE/HSI Verification were incorporated into this new review element. However, this new element was not finalized at the time of the AP1000 review, thus the verifications are identified in the V&V Design Commitments, specifically commitment # 5 items d and e. This should be clarified in the guidance since it is AP1000 (and ABWR, System 80+) specific.

4.3.9.18.12 4.3.9.18.12-1 S

210 Paragraph 4: The COL Applicant Guidance states, A final issue that the COL applicant should consider is the vastly increased level of digital information processing (and data collection) that will be enabled by the new plant I&C systems. These data collection capabilities will invite the collection and evaluation of greatly increased amounts of data.

Given the difficulty of establishing valid metrics, and the potentially sensitive issues of human performance monitoring and evaluation, it is recommended that a conservative approach be taken on the addition of new performance metrics. Please clarify the issues mentioned and the characteristics of a conservative approach.

4.3.9.19.1 4.3.9.19.1-1 220 Paragraph 1: This introductory section states that The plant-specific PRA is not part of the COLA FSAR, just as the design PRA was not part of the generic DCD for purposes of design certification. Noting that COLA and pre-startup PRAs have different objectives compared to the design PRA, and that part 52 requires a PRA submittal, the report needs to be revised to meet the Part 52.

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Proposed Change 4.3.9.19.2 4.3.9.19.2-1 223 It is correctly mentioned on page 222 that at the time of COL application the COL applicant should use the best available information (e.g., site characteristics, design and construction drawings, etc.). However, Table 4.3.9.19-1 is titled COLA items, including items that cannot be completely resolved at the time of COL application. It is apparent that AP1000 tables do not reflect the phased approach for updating the PRA. The guidance in the report should include discussions for treating COL items at each stage of updating (e.g., what can be resolved or partially resolved at the COLA stage).

4.3.9.19.2.1 4.3.9.19.2.1-1 226 The discussion at the bottom of this section needs to be expanded via providing examples of information that should be provided at the COLA stage.

4.3.9.19.2.2 4.3.9.19.2.2-2 226 Screening is mentioned in these sections as a tool for identification of changes with significant impact on risk. Is screening intended to be based on engineering judgment only? Are there any intentions of providing guidance or criteria in this area? The report user should also consider the impact of multiple low significance changes that collectively may have a significant risk impact. Item b on page 230 of the report hints using the design-specific PRA in assessing the significance of certain identified differences as an alternative to screening. The challenge with establishing screening/deferral guidelines is that it is very difficult to make a qualitative argument that the quantitative risk results will be unaffected.

NEI 04-01 should provide a more complete list of the reasons why a plant change could be deferred. Applicants using NEI 04-01 should maintain a complete list of all changes, their current treatment in the PRA (i.e., incorporated, deferred until..., etc.), and the reason(s) why certain changes are not yet captured in the PRA (e.g., choose one or more of the reasons listed in NEI 04-01). The staff should have access to this list and could, at any time, elect to perform an audit. Expanded guidance is needed in this area and needs to take into account the staffs concerns regarding screening identified in the previous comment.

4.3.9.19.2.2 4.3.9.19.2.2-1 227 Paragraph 3: The subject of screening is discussed in several places within in the report.

For example, the statement If the effects of the differences are shown by screening analysis to potentially result in significant increase in core damage frequency (CDF) or large early release frequency (LERF), PRA will be updated.... As previously mentioned in the general comments, we would expect that the final PRA (after plant startup) would reflect the as-built, as-operated plant without exception. Therefore, the concept of screening should be replaced with the concept of deferring. Since the staff, ACRS, and Commission have previously indicated their position that the PRA should be used as a design aid (during the evolution of the standard certified design into the final as-built, as-operated plant), the proper question is how to decide when (not if) plant changes should be evaluated using PRA. Obviously, some changes may have a major impact on the risk results and should be evaluated without delay.

Other changes will have only a small or negligible impact, and their incorporation into the PRA may be deferred to a final PRA update. The report needs to include a screening process and provide criteria for screening.

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Proposed Change 4.3.9.19.2.3 4.3.9.19.2.3-1 232 Item d: The note should recommend that a realistic fire PRA be developed at least for the phase 2 (pre-startup) PRA update. A fire PRA should be developed at the earliest opportunity, when the plant engineering drawings include sufficient relevant spatial information (e.g., cable routes).

4.3.9.19.2 4.3.9.19.2-2 232 The basic approach for developing a plant-specific PRA is to update the design-specific PRA for differences that cannot be determined to be insignificant. Therefore, if all differences are determined to be insignificant, then the plant-specific PRA would be identical to the design-specific PRA. This approach conflicts with other parts of Section 4.2.9.19 (e.g., Table 4.3.9.19-4, item 19.2.2 fourth bullet, page 236, which implies that all plant-specific differences would be addressed).

4.3.9.19.3 4.3.9.19.3-1 238 Table 4.3.9.19-4, Item 19.2.2, Bullet #7: It is stated that the plant-specific PRA would be ASME capability Category 2. This is not possible, as noted in Section 4.4.3.2.2, page 248, since there would be no operating experience. The staff interprets the intent as being in those areas in which it is possible to meet Capability Category 2, the PRA will meet these supporting requirements (including those that are the same across capability categories).

4.3.9.19.3 4.3.9.19.3-2 239 Table 4.3.9.19-4, Item 19.2.4 (s/b 19.4.2): The comparison of the plant-specific PRA to the design-specific PRA must include a comparison of the risk profile. Changes to the risk profile must be explained (e.g., sequences arising from the site-specific external events PRA).

4.4.4.3 4.4.4.3-2 249 It is clear that walkdowns will be done in the pre-startup phase. However, it is noted that unlike seismic walkdown, there is no guidance for fires and flooding that assures consistency in the conduct of their walkdowns. Development of guidance is needed in these areas.

4.4.4 4.4.4-1 250 Item c: Change Identify any differences... to Identify and document any differences...

4.4.4.3 4.4.4.3-1 251 Change identify any differences to identify and document any differences...

4.4.4.2 4.4.4.2-1 251 Note at the section bottom: This note needs to be further clarified. It appears to be saying that the thermal-hydraulic analyses (e.g., for success criteria) and materials access MAAP analysis (e.g., for severe accident progression) need not be repeated. However, if the design has changed in some manner, how can one tell whether the original analyses done for design certification are still applicable and appropriate, unless these evaluations are repeated? If the plant-specific design and operating parameters have changed in any way from those in the design analyses, plant-specific evaluations should be performed to confirm that the design certification calculations are still applicable and appropriate.

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Proposed Change 4.4.4.2 4.4.4.2-2 251 The staff should require applicants to maintain their importance, sensitivity, and uncertainty analyses during PRA updates. These can be done in a very short time and with little effort, thanks to modern PRA software. The importance and sensitivity analyses are helpful in understanding the impact of plant changes. The uncertainty analysis is needed to place the quantitative results (e.g., change in CDF) into proper perspective (e.g., a perceived change in the mean CDF may be negligible when compared to the uncertainties involved).

4.4.6 4.4.6-1 254 Paragraph 2: This section refers to Section 4.5.4.2 which does not exist in the report.

4.6.5 4.6.5-2 258 Paragraph 2: The discussion of Severe Accident Mitigation Design Alternatives (SAMDA) is very brief, and needs expansion. In case of applicants referencing a certified design, the applicant would still need to confirm that the SAMDA evaluation (performed as part of design certification) remains valid for the proposed site. This would involve performing site-specific consequence analyses for the as-built design and confirming that there are no additional SAMDAs that warrant implementation.

4.6.5 4.6.5-1 258 Paragraph 1, last sentence: States The probabilistic evaluation of severe accident risk for a given site is provided and resolved at early site permit (ESP), which is true. However, as stated in the ESP environmental impact statement report, the COL applicant will need to verify that the environmental impacts of design-basis accidents and safety analyses at the ESP site remain bounded by the environmental impacts from the surrogate designs considered in the ESP review.

6.2.2.2 6.2.2.1-4 272 Departures Affecting Resolution of Severe Accident Issue - Statement under Item 1: If the staff reviewed a particular severe accident, then it was considered credible. This statement is not consistent with that concept.

6.2.2.2 6.2.2.1-8 273 Departures Affecting Resolution of Severe Accident Issue - Bullet regarding dose at the exclusion area boundary (EAB): The statement is not clear. Does the dose at EAB refer to dose from the affected sequence only? Or total dose from all sequences (probability weighted sum)? Is the cumulative effect of all changes considered, or is this criterion applied separately for each individual change? This criterion needs to be reconsidered.

6.2.2.2 6.2.2.1-5 273 Departures Affecting Resolution of Severe Accident Issue - Paragraph 2: severe accident with a CDF contribution < 1 E-6 / yr: The problem here is that the total CDF for ALWRs is estimated to be < 1 E-6 per yr (e.g., 1 E-7 for AP-600). The proposed criterion would imply that severe accidents as a whole are not credible, not to mention the individual sequences that contribute to CDF. Use of a threshold value of 1 E-6 would allow ignoring a multitude of sequences whose cumulative contribution could be much greater than the very low total CDF characterizing ALWR designs.

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Proposed Change 6.2.2.2 6.2.2.1-7 273 Departures Affecting Resolution of Severe Accident Issue - Bullet related to change in dose/uncertainty: The statement under this bullet is ill-defined. One can argue that the uncertainty bands are a factor of 10 higher and lower. As such, this criterion could be used (inappropriately) to permit significant changes to be made to the design.

6.2.2.2 6.2.2.1-6 273 Departures Affecting Resolution of Severe Accident Issue - 10 CFR 50.34(a)(1)(i)(D) dose:

These doses (25 REM at the boundary) are calculated using a prescribed source term and assuming the event occurs (with probability of 100%). Changes that affect CDF would not impact this calculation. The only changes that impact the calculation would relate to systems credited for FP removal, or containment integrity. This criterion needs to be reconsidered.

S - Suggested change to improve guidance.

C - Comment NRC Staff believes needed to make guidance reflective of NRC regulations and guidance.

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