ML18129A197

Public Comment Disposition Table for Regulatory Guide 1.206, Revision 1

ML18129A197
Person / Time
Issue date:	10/03/2018
From:	Hayes B Office of New Reactors
To:
Hayes B
References
DG-1325, RG-1.206, Rev 1
Download: ML18129A197 (35)

Text

Response to Public Comments on Draft Regulatory Guide (DG)-1325 Applications for Nuclear Power Plants Proposed Revision 1 of Regulatory Guide (RG) 1.206 On June 15, 2017, the NRC published a notice in the Federal Register (22 FR 28101) that Draft Regulatory Guide, DG-1325 (Proposed Revision 1 of RG 1.206), was available for public comment. The Public Comment period ended on September 18, 2017. The NRC received comments from the organizations listed below. The NRC has combined the comments and NRC staff responses in the following table.

Comments were received from the following:

Michael D. Tschiltz, Senior Director New Plant, SMRs and Advanced Reactors Nuclear Energy Institue (NEI) 1201 F Street, NW, Suite 1100 Washington, DC 20004 ADAMS Accession No. ML17265A049 Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

1. Title The title of the regulatory guide (RG) Revise title to: Applications for Nuclear Partially Disagree: The current title should reflect its focus as described Power Plants Under 10 CFR Part 52 Applications for Nuclear Power in under Purpose and Applicability. Plants is intentionally broad and includes guidance relative to regulatory requirements outside of 10 CFR Part 52 and has relevance to applications for construction permits (CP) and operating licenses (OL) issued under 10 CFR Part 50 that may reference an ESP issued under 10 CFR Part 52. Furthermore, in the 2014 periodic review of RG 1.70, Standard Format and Content of Safety Analysis Reports for Nuclear Power Plants (LWR Edition), NRC staff referenced a later phase of updating RG 1.206, Combined

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section License Applications for Nuclear Power Plants, (LWR Edition) envisioned that would provide guidance for applications for CP and OL. This planning from 2014 has not been revisited in the context of current competing priorities related to guidance.

2. General The industry supports the migration of In connection with the migration of RG 1.206 Partially Disagree: The comment and appropriate RG 1.206 technical guidance technical guidance into the SRP, the NRC should recommendation do not relate to the into the standard review plan (SRP). A re-evaluate the Review Areas and Review revision of RG 1.206. However, the staff major lesson learned from recent licensing Criteria in each SRP section and revise, plans to consider stakeholder experience is that as a result of the SRP, consolidate, or eliminate those that seek participation in the planned knowledge requests for additional information (RAIs), information beyond that necessary to support management document containing and less formal processes, applications required reasonable assurance findings by the detailed technical application guidance have grown to include more information staff. The NRC should seek extensive for a COL FSAR.

than is necessary to support the required stakeholder participation in the migration effort. With regards to future SRP updates, reasonable assurance findings by the stakeholder input will be sought. It staff. should also be noted that NRC recently presented an initiative related to SRP revisions that reinforces the focus on reasonable assurance of adequate protection. The summary of the public meeting can be found at ADAMS Accession No. ML18242A260.

3. General [Editorial] Fix numerous punctuation problems, Agree: Revised in multiple locations.

including frequent double punctuations such

4. A. Introduction, Related Given recent work on Advanced Reactor Add a note or parenthetical statement regarding Agree: Revised text by adding: The Regulations and Guidance, bullet on Design Criteria (ARDC), it would be ARDCs. NRC issued RG 1.232, Guidance for Appendix A, pg. 3 worthwhile to mention that principal Developing Principal Design Criteria design criteria for non-light-water for Non-Light-Water Reactors, to reactors (non-LWRs) are informed by provide guidance on how the general ARDCs. design criteria (GDC) in 10 CFR Part 50, Appendix A, may be adapted for non-light-water reactor (non-LWR) designs.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section RG 1.232 was also added to the references.

5. A. Introduction, Related The discussion of application for a Change discussion to reflect Part 52 Partially agree: This has been Regulations and Guidance, bullet on construction permit and associated licensing processes. revised to reflect Part 52 licensing Appendix B, pg. 3 preliminary safety analysis report are processes. The revised text is as inappropriate for this document. follows:

10 CFR Part 50, Appendix B, Domestic Licensing of Production and Utilization Facilities, sets forth the requirements for quality assurance programs for nuclear power plants and is applicable to applications for ESPs, DCs, and COLs as per 10 CFR 52.17(a)(1)(xi), 10 CFR 52.47(a)(19) and 10 CFR 52(a)(25) and 10 CFR 52(a)(27).

6. A. Introduction, Related Given the staffs announced plans to Clarify that this RG and changes to Partially Agree: The staff will clarify in Regulations and Guidance, bullet on transition RG 1.206 and NUREG-0800, NUREG-0800 will eventually replace RG 1.70. the Federal Register Notice for the RG 1.70, pg. 4 Standard Review Plan for the Review of update to RG 1.206 that RG 1.70 is not Safety Analysis Reports for Nuclear Powers being withdrawn. The staff may, (LWR), toward replacing RG 1.70, the however, set a date beyond which citation here (with no clarification) is applicants should no longer rely on RG confusing. 1.70 for licensing applications under 10 CFR part 50 and may develop alternate guidance in the future.

7. A. Introduction, Related [Editorial] Several of the documents Correct formatting. Agree: Corrected.

Regulations and Guidance, pg. 4 listed appear to be incorrectly formatted (indented) making them appear as sub-tier documents.

8. A. Introduction, Related There is no discussion here of the Make at least parenthetical note of the fact that Disagree: Staff does not expect to Regulations and Guidance, bullets on pending plan to supersede these these are being superseded. supersede COL/ESP-ISG-026 and COL/ESP-ISG-026 and 027, pg. 4 documents as discussed later in COL/ESP-ISG-027 before issuance of document. the revision of RG 1.206. This portion of the introduction simply references 3

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section guidance documents and does not provide status updates on planned revisions.

9. B. Discussion, Background, pg. 8, [Editorial] After NUREG-0800, Correct editorial error. Agree: Corrected.

2nd paragraph there are redundant references to SAR and Safety Analysis Reports.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

10. B. Discussion, Background, First, the staff creates an interim The NRC should highlight changes to Partially agree: Text has been revised to pg. 8, 3rd paragraph application guidance document (IAG) RG 1.206 technical guidance to be migrated reflect uncertainties regarding the long that is referenced in the SRP introduction into the IAG on its way to the SRP, provide term planning for the IAG as discussed section is not very clear. Is there a additional clarification on timing and construct in the DG issued for public comment.

document number? of IAG, and provide opportunity for stakeholder The near term goal is to make updated How does the timing compare to comment. application guidance available via an the RG and SRP revisions? ISG, NUREG or other public document.

The new knowledge management The text says that the IAG will document is considered a near term include lessons learned since product to be completed during FY the issuance of RG 1.206, 2019. The revised text is as follows:

Revision 0. Stakeholders should be provided an opportunity to The technical application guidance comment on this new information. for a SAR that was previously included in RG 1.206, Revision 0, is being updated to reflect lessons learned and will be developed into interim staff guidance (ISG), a NUREG, or other knowledge management document Stakeholders will be provided an opportunity for input to the document via a FRN requesting public comments. The document is expected to be useful to both applicants and to staff working on future updates to the SRP and related RGs; however, direct incorporation of applicant guidance in the SRP is not expected.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

11. B. Discussion, Background, The use of regulatory positions here is a Replace positions with guidance. Agree: Changed.

pg. 8, last paragraph bit confusing.

12. B. Discussion, Background, pg.9, [Editorial] The appendices referred to Correct terminology by replacing Agree: Corrected.

last paragraph for Section C.2.7 and C.2.18 are appendices/appendix with actually supplements. supplements/supplement. Change C.2.8 in In the last sentence, C.2.8 should be the last sentence to C.2.18.

C.2.18.

13. B. Discussion, Background on The first paragraph of this section Clarify that use of ESP and DC are options, or Agree: Changed.

License, Certification, and Approval leaves the impression that an early rearrange discussion to make this point clearer.

Processes under 10 CFR Part 52, site permit (ESP) and design Perhaps a simple edit such as The regulations pg. 9, 1st paragraph certification (DC) are required. This is in Title 10 CFR Part 52 provide options for clarified later but could be confusing early resolution of safety and environmental as written. issues before authorizing construction would suffice.

14. B. Discussion, Background on The paragraph that begins, A holder Clarify that these materials licenses are Agree: Changed and added a reference License, Certification, and Approval of a COL issued under 10 CFR typically applied for. to Section C.2.13.

Processes under 10 CFR Part 52, Part 52 obtains materials licenses pg. 10, 2nd paragraph issued under 10 CFR Parts 30, 40, and 70 could be confusing.

15. B. Discussion, Harmonization This section is ambiguous with regard Clarify whether the staff intends to endorse or Agree: Added the following with International Standards, pg. 10 to the extent to which the staff accept use of international standards or delete statement:

acknowledges or uses international section. NRC staff does not intend to endorse or standards. accept use of any specific international standards via this regulatory guide.

16. C.1 Application Format and The last sentence of the first Clarify that this variability is acceptable. Agree: On page 12 revised to state that Content, pg. 12, 1st paragraph paragraph states, Furthermore, NRC staff recommends and added each application should adhere to following text:

the standard format and content identified herein.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section Though the standard format facilitates the Certain aspects of applications have application and review processes and is been subject to variation in the past, useful for organizing guidance, adherence e.g., different Parts used for same or to the standard format is not required by similar content. regulation.

This comment also applies to the Added the following text on page 13:

subsection Application Parts, on Though use of the standard format is not page 13 and various other places in required by regulation, organization of document; e.g., C.1.X, Part X of the content by the parts described in Table 1 application under Part 52 includes facilitates the application and review implies that this structure is mandatory processes as well as the organization of under the regulation. guidance.

17. C.1 Application Format and Clarify The NRC staff considers the Suggest an edit along the lines of: The NRC Agree: Changed as suggested. Also made Content, pg. 12, 3rd paragraph guidance in Section C.1 on application staff considers the guidance in Section C.1 on similar change on page 1.

format and content is applicable to any type application format and content to be generally of reactor (i.e., nonlight-water reactors applicable to other reactor types (e.g., non-(non- LWRs)). While purely editorial, use light- water reactors [non-LWRs]).

of i.e. implies non-LWRs are the only other type of reactor. Yet, not all aspects of content will be applicable.

18. C.1 Application Format and Application transmittal letter, item e does Consider additional discussion/guidance on Agree: Additional guidance was provided in Content, Application Transmittal not include discussion of Export Control applicant submittal of ECI, particularly applicant Section C.1 under the subheading entitled Letter, item e., pg. 12 Information (ECI). obligations under ECI regulations and what Transmittal Letter.

responsibility NRC staff accepts regarding control of ECI once received.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

19. C.1 Application Format and Part 8 of the application should be Expand the Table 1 title of application Part 8 to be: Disagree: No change to Table 1.

Content, Application Parts, Table 1, expanded to include Tier 1 information. License Conditions; Tier 1 Information; ITAAC.

pg. 14 Staff disagrees with the recommended In addition, Section C.1.8 should be expanded change to guidance and specifically the to address the inclusion in Part 8 of Tier 1 suggestion that all of Tier 1 should be information, as applicable, (i.e., if a design included in Part 8. Tier 1 information, certification is referenced). excluding ITAAC, represents the certified portion of material that is required in FSAR under 10 CFR Part 52.47(a).

The colocation of related Tier 1 and Tier 2 technical information will additionally result in more efficient reviews by tying high level certified technical information to the supporting detailed technical information.

Similarly, colocation will make more efficient reviews of technical issues for later COL LARs rather than separating linked information based solely on different change processes.

This comment is referenced by comment

1. 28 which was referenced by comment

1. 61. It is also related to comments # 22, 59, and 92.

20. C.1.2 SAR, pg. 16, 1st Correct typos in COLA in 10 in CFR Correct editorial error. Agree: Corrected.

paragraph 52.79

21. C.1.2 SAR, Combined License The discussion of a combined license Mention these additional options for completeness. Agree: Text revised to clarify that the Application, pg. 16-18 application (COLA) that incorporates by requirements of 10 CFR 52.79(a) applies reference (IBRs) a DC, and of COLA that the various options.

IBRs a DC and an ESP, imply that a COLA that IBRs an ESP but not a DC is not an option. There is also no discussion of a COLA that incorporates neither a DC nor an ESP.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

22. C.1.2 SAR, Design Certification A sentence in the paragraph states We recommend that this guidance be corrected Disagree: Slight revision to reflect the Application, pg. 18,1st paragraph The DCR appendices to 10 CFR Part and clarify that 1) Tier 2 of the DCD is analogous fact that though the term analogous 52 are similarly structured and contain a to FSAR information required by 10 CFR 52.47(a), may be appropriate, it is not clearly common set of definitions and and 2) Tier 1 is separate from the FSAR and stated in the definitions section of the terminology that includes defining the includes ITAAC required by 10 CFR 52.47(b). appendices.

DCD for a DC as being analogous to the Staff, however, disagrees with the FSAR required by 10 CFR 52.47, statement that Tier 1 is separate from the Contents of Applications; Technical FSAR. SECY-90-377 stated on page 6 Information. Additionally, the DCRs that:

establish a two-tier hierarchy of design- An application (Tiers 1 and 2) will related information (Tier 1 and Tier 2). contain a depth of design detail similar to that of a final safety The sentence misstates the design analysis report (FSAR) at the certification definition of design control operation license (OL) stage for a document (DCD). Moreover, the DCD is recently licensed plant (1985-90),

not analogous to the FSAR. minus site-specific and as-built information. (underlining for emphasis)

The Tier 1 & 2 definitions are used to separate material that has been approved rather than approved and certified. The DC FSAR contains material required under 10 CFR 52.47(a) regardless of whether it is ultimately certified.

Note: Comments 19, 22, 28, 59, 61, and 92 are all related to the question of whether Tier 1 is considered part of the FSAR.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

23. C.1.2 SAR, Early Site Permit The term design information should be In the 2nd sentence, change design information to Agree: The staff believes that the Application, pg. 19 used to describe the content of design details. commenter meant to recommend applications (ESP and others), rather changing design details to design than design details as found in the first information. Revised by changing full paragraph on page 19. design details to design information.

24. C.1.2 SAR, Early Site Permit The first full paragraph on page 19 Revise to state, plant perimeter parameter Agree: Corrected.

Application, pg. 19 defines PPE as plant perimeter envelope (PPE) envelope. Perimeter should be parameter as used in item b. of the list following the paragraph.

25. C.1.2 SAR, Early Site Permit The first full paragraph on page 19 would Further illustrate what a controlling PPE value is Agree: Revised but noted that a Application, pg. 19 benefit from clarification on two points and clarify that a COLA may reflect a design that variance request would be required by related to controlling PPE value, or exceeds the plant parameter envelope, but that the the COL applicant. With regards to any bounding parameter value. COLA must explain/justify any such variance and risk to the finality of an ESP, the finality that the ESP finality would be at risk. of the ESP is not otherwise affected by a Revise the paragraph to state, one that variance in a COL or COLA that necessarily controls the value of a site references the ESP.

characteristic in the context of site suitability (e.g.,

site meteorology X/Q values established within the PPE for the purposes of evaluating the postulated design performance). As the PPE is intended bounding parameter values. Following selection of a design, if a design value exceeds the PPE bounding value, such variances must be explained in a COL application. As illustrated in

26. C.1.5 Emergency Plans, pg. 23 The list of application parts is prefaced Provide additional clarification on when the content Disagree: The paragraph that precedes with, Part 5 of the COLA, or as that follows is applicable for an ESP. the list in question cites the applicable applicable in an ESP application It is regulations and explains that there is a not clear which items are/are not large range of levels associated with EP applicable in an ESP application. related information for an ESP.

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27. C.1.7 Exemptions, Departures, The guidance provided in Sections B and Revise the guidance for Part 7 to read as follows: Agree: Revised as requested with some and Variances, pg. 25-26 C is, in part, not clear and redundant, In accordance with Section X of 10 CFR Part 52 modifications and additional specificity.

and, in part, requesting information that appendices, a COL applicant who references a is beyond the scope of the design certified design shall prepare and maintain written certification rulemakings. evaluations which provide the bases for making plant-specific departures under Section VIII of the certification appendix. These evaluations must be retained throughout the period of application and for the term of the license (including any period of renewal).Section X also requires each COL applicant to provide in its initial application submittal a report that contains a brief description of any plant-specific departures from the referenced DCD, including a summary of the evaluation of each.

These summary reports should be similar in format and level of detail as reports submitted by operating reactors as required by 10 CFR 50.59. This report should be included in Part 7.

For departures that do not require prior NRC approval per Section VIII, no additional departure description information needs to be included in Part 7.

For a COLA that is a subsequent COLA (or S-COLA), it is anticipated that previous COL applicants (i.e., a reference COLA, or R-COLA) or COL holders referencing the same design certification will have developed these reports for standard departures approved per Section VIII (standard departures are presumably applicable to all applications that reference the same design). A COL applicant may incorporate by reference these reports in lieu of repeating the information in Part 7, provided that each departure evaluation is reviewed and found applicable to the COL applicants site/plant. If, because of plant-specific considerations, additional evaluation of the departure is necessary, the COL 11

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section applicant should supplement the referenced reports with a summary of the plant-specific evaluation. For departures/exemptions requiring prior NRC approval, Part 7 should include the following information:

a) The scope and summary of the request; b) Justification relative to the specific application with cross-references to applicable regulatory guidance and/or requirements; c) A technical and regulatory evaluation relative to safety significance and regulatory acceptance criteria (e.g., 50.12,Section VIII of referenced DC rule);

d) For exemptions, an evaluation against the exemption criteria; and e) A statement identifying the need for NRC approval or need for an exemption However, if a COL holder referencing the same design certification has obtained NRC approval for the same departures or exemptions, the S-COL applicant may incorporate by reference into Part 7 the evaluations submitted in those license amendment/exemption requests, in lieu of repeating this information in Part 7, and also reference the NRC letter enclosing the applicable safety evaluation (SE). This information will aid the NRC staff in determining that no additional staff review of these changes is necessary.

With respect to requests for variances, Part 7 should include the following information:

a) A description of the variance b) A justification for the variance 12

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

28. C.1.8 License Conditions and The last sentence states, The applicant To avoid confusion, the guidance should make Disagree: Minor correction of a Inspections, Tests, Analyses, and may (1) include the entirety of Tier 1 clear that Tier 1 is not part of the FSAR and thus typographical error to reflect that ITAAC Acceptance Criteria, Inspections, information in Part 8 of the application should be included in Part 8 of the application. may be included in Part 2 along with Tests, Analyses, and Acceptance or, (2) include the Tier 1 design other Tier 1 information. Staff disagrees Criteria, pg. 26, 3rd paragraph descriptions, significant interface with the statement that Tier 1 is not part requirements, and significant site of the DC FSAR. The passage now parameters in Part 2 of the application states The applicant may (1) include and provide the ITAAC in Part 8. the entirety of Tier 1 information in Part 2 of the application or, (2) include the This paragraph confuses the issue of Tier 1 design descriptions, significant whether Tier 1 is part of the FSAR. See interface requirements, and significant comment #19. site parameters in Part 2 of the application and provide the ITAAC in Part 8.

In response to comment #16, the text has been revised to clarify that Application Parts as laid out in this guidance are not mandatory. The guidance provided here is representative of this flexibility, however, 10 CFR 52.47(a) requires that a DC applicant submit an FSAR.

NB: Comments 19, 22, 28, 59, 61, and 92 are all related to the question of whether Tier 1 is considered part of the FSAR.

29. C.2 Application Regulatory The first sentence should be clarified. Revise to read generally apply to both LWR and Agree: Changed with modification:

Topics, pg. 29, 2nd paragraph other types of power reactors. generally apply to LWR and to potentially apply to ..

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

30. C.2 Application Regulatory The last sentence states, However, the Replace has limited applicability with may have Agree: Changed as suggested.

Topics, pg. 29, 2nd paragraph guidance on specific regulatory and limited applicability.

technical issues (e.g., 10 CFR Parts 30, 40, and 70 material licenses for COLs and design- specific review standards (DSRS) for SMRs) focuses on LWR technology and has limited applicability to non-LWR applicants.

Certain such topics do have applicability.

31. C.2.1 Preapplication Activities, This section does not reflect recent Enhance this discussion to reflect recent Agree: Discussion added regarding pg. 29 et seq. discussions within the Advanced Reactor discussions between the staff and the Advanced concept of regulatory engagement community regarding the use of Reactor community. plans which should support better Regulatory Engagement Plans or the engagement between applicants and various regulatory tools available to reduce staff and clearer expectations licensing risk through more systematic regarding scope, schedules and costs NRC staff feedback. As an alternative to of review. This section also now staged application reviews and approvals includes a discussion of staffs (e.g., development of so-called conceptual enhanced safety-focused review design assessments), the staff has approach (ESFRA) which is important suggested that existing tools, such as for pre-applicants to understand in the those used for PRISMs PSER, are pre-application phase.

available for new reactor developers to seek early staff feedback on specific topics. Prior pre-application interactions have suffered at times from inconsistent levels of staff engagement and lack of feedback to multiple submittals, such as technical reports, and these sorts of tools can help enhance pre-application engagement.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

32. C.2.1 Preapplication Activities, Section C.2.1, Preapplication Activities, is Public and Non-public meetings (Page 30) - Partially agree: Revision made to reflect pg. 29 et seq. disappointing with regard to the The RG should establish an expectation for flexibility with reference to the concept of expectation [importance] for NRC to staff to issue meaningful minutes identifying regulatory engagement plans as a vehicle provide meaningful feedback during the and documenting any issues identified that for more concise discussion and agreement pre-application process. As written this NRC believes would benefit from resolution between NRC staff and a potential future looks like a one way information flow from prior to submittal of an application. applicant regarding the level of NRC staff the applicant to the staff with no feedback along with associated costs and expectation on the staff to provide any Plans and Schedules (page 31) - The RG should schedule impacts during pre-application.

meaningful feedback. While it is clear that require NRC staff to provide meaningful feedback Vehicles for feedback to potential applicants pre-application engagement is generally on plans and schedules submitted so that the already exist; such as gap letters or not binding, the staff should be expected applicant can adjust accordingly or work to align meeting summaries. The level of feedback to provide meaningful written feedback that on schedules. provided is often commensurate with the will help the applicant address any level of detail and certainty provided by the potential technical issues prior to applicant.

submitting an application. There has to be some meaningful documented feedback from NRC to make pre-application activities worthwhile and improve the efficiency of the regulatory process.

33. C.2.1 Preapplication Activities, This section does not discuss or delineate The RG should establish a clear expectation Partially agree: See response to GUIDANCE, Meetings, Subsequent any need for, or venue for, formal staff that the NRC staff provide meaningful meeting comment 32.

Meetings, pg. 33 feedback during or after these pre minutes that clearly identify any potential application meetings are conducted. technical or process issues that would benefit from further dialogue and resolution prior to submittal. In addition the guidance should reflect that the NRC licensing PM, with input from NRC staff and management attendees, should document a detailed meeting summary that provides clear feedback from the staff on the subjects discussed along with any decisions or significant staff comments.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

34. C.2.1 Preapplication Activities, All documents submitted by the The RG should state that NRC provides Partially agree: See response to GUIDANCE, Documents, pg. 33-35 applicant should receive some level of written feedback on documents submitted - comment 32. RG revised also regarding written feedback. not just Topical Reports. letters.

This section does not include letters from A fourth type of document, letters, should be added the prospective applicant to the NRC. to this section after white papers. A letter formally documents key regulatory subjects and should be responded to by the NRC in a letter within a reasonable time frame of no more than 90 calendar days.

35. C.2.1 Preapplication Activities, The criteria for a topical report should Revise the criteria for a topical report to Agree: Revised as recommended with GUIDANCE, Documents, Topical include the fourth criteria regarding include the fourth criteria regarding licensing minor modifications.

Reports, pg.34 licensing efficiency. In addition the RG efficiency and to expand on improving should expand on improving regulatory regulatory efficiency for new reactors or novel efficiency for new reactors or novel designs such that a Topical Report can and designs such that a Topical Report can should be used to improve the application and should be used to improve the review process for singular but very important application review process for singular technical issues regardless of whether it can but very important technical issues be used by multiple applicants.

regardless of whether it can be used by multiple applicants. This should obviate the need for exhaustive justification from the applicant as to why the topical report is appropriate. If Staff believes this requires a change to LIC-500 that should be pursued in concert with the RG revision. This comment is based on experience where staff has been resistant to a Topical Report for a one-off critical technical issue.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

36. C.2.1 Preapplication Activities, Reiterating comment #31, The staff may Reflect a more flexible approach to providing Partially agree: See response to GUIDANCE, Documents, Technical issue RAIs, but will not publish issue- meaningful staff feedback to technical reports and comment 32.

Reports and White Papers, pg.34 and specific SE reports; instead, the staff will white papers.

35 incorporate the technical reports and its associated evaluation into the overall Expand the Technical Reports section to state that, review/evaluation of the application Technical Reports are a legitimate vehicle for early reflects what can become a one-way staff feedback and review prior to an application.

exchange that does not benefit the While this early review would not result in and prospective applicant or reflect sufficient SER, staff will be expected to provide meaningful value for what can be a significant documented feedback. Additionally, if the NRC expenditure of time and resources to try provides RAIs, staff will document their acceptance to secure early feedback for technical of RAI responses and will document clarification topics. Lack of any commitment to meetings on the technical report in a detailed and provide NRC staff feedback on white meaningful summary letter.

papers beyond the option to informally request clarification or supplemental The RG should require staff to provide written information similarly results in limited feedback on white papers with identification of benefit for significant investment of time issues that would benefit from further dialogue or and resources. resolution prior to submittal of an application.

Both sections should specify some Expand the White Papers section to state that expectation for typical review schedules the NRC will document clarification or and documented feedback supplemental information meetings on the mechanisms. white paper in a detailed and meaningful summary letter.

37. C.2.1 Preapplication Activities, Under Documents, it does not appear to Clarify/revise the last paragraph text under Partially agree: See response to GUIDANCE, Documents, White be correct that White Papers, including White Papers regarding the use/handling of comment 32 and revisions of RG relative Papers, pg.35 those submitted via NEI, do not receive white papers by the NRC staff to reflect that, to white papers..

a formal review and evaluation by the depending on the paper content, the staff may staff. perform a formal review and evaluation of white papers.

38. C.2.1 Preapplication Activities, The last sentence before the bullets Revise to state, , to support required safety Agree: Changed as recommended.

GUIDANCE, Safety and Environmental should be more precise with respect to and environmental findings its anticipated Issues, pg.35, 2nd paragraph the level of detail to be sought from reviews on such issues as .

applicants.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

39. C.2.1 Preapplication Activities, DG-1325 states that an NRC site tour These pages should be revised to site Agree: Changed by adding the following:

GUIDANCE, Environmental should be completed early in the pre- explicitly that NRCs tours are up to the Preapplication Activities, pg. 36-37 application process, and that the NRC discretion of the pre- applicant and may Though strongly recommended, a may request a tour of alternative sites. deferred until after submission of the site tour is at the discretion of the Some applicants may not desire a site application. pre-applicant and may be deferred tour or a tour of alternative sites during until after submission of the the pre-application review. application.

40. C.2.1 Preapplication Activities, DG-1325 states that during the pre- This page should be revised to site explicitly Agree: Changed by adding the following:

GUIDANCE, Environmental application review, the NRC may seek that the scope of NRCs pre-application Preapplication Activities, pg. 36 information on a number of different environmental review is up to the discretion of The applicants response to NRC staff topics, including historical site the pre-applicant and that the pre-applicant pre-application environmental review information, alternative sites, and does not need to submit the listed information. requests is up to the discretion of the socioeconomics. Some applicants may pre-applicant. The pre-applicant is not not desire the NRC to review such required to submit information in information during the pre- application advance of the submission of the review. application.

41. C.2.1 Preapplication Activities, The sentence before the bullets should Revise to read NRC staff will seek Agree: Changed as recommended.

GUIDANCE, Environmental be more precise with respect to the information, in sufficient level of detail, to Preapplication Activities, pg. 36, 2nd level of detail to be sought from support required environmental findings its paragraph applicants. anticipated reviews on such issues as

42. C.2.2 Pre-application Readiness This section does not reflect recent Amend guidance or reflect in this RG the Partially agree: Minor changes to reflect Assessment, pg. 37 et seq. significant challenges with pre- clarifications needed to address improvements earlier discussion of regulatory application assessments that indicated in expectations, communications, and engagement plans in Section C.2.1, no significant issues associated with a predictable outcomes for readiness Pre-application Activities. The pre-draft application, only to be changed assessments. application readiness assessment is after the assessment was conducted, voluntary and does not predetermine followed by an acceptance review that whether the application will be accepted took several months. The readiness and docketed as stated in this section.

assessment process still cites 2014 The assessment can be focused on procedural guidance that apparently selected topics and can also reflect a has not been updated to reflect lessons regulatory engagement plan if from these experiences. developed for an application.

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Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

43. C.2.2 Pre-application Readiness Discussion of planned exemption Include specific pre-application engagement Agree: Revision made to Section C.2.1 Assessment, OVERVIEW, pg. 38 requests at the readiness assessment on planned exemption requests in meetings that identify exemptions as a long lead 6-months before application will not and white papers in Section C.2.1, before the time activities that need to be identified support an efficient and timely review of readiness assessment in Section C.2.2. in the pre-application phase. The the DCA if this is the first time this Interaction on this subject at six-months applicant readiness assessment can be subject is addressed with the NRC. before application does not allow sufficient conducted earlier than six-months time for staff and NRC management before application submittal.

evaluation and feedback to the prospective applicant.

44. C.2.2 Pre-application Readiness The statement that, the readiness Revise the statement as follows, Although not Agree: Revised as recommended.

Assessment, GUIDANCE, pg. 38, 3 r d assessment neither conforms to nor is part of the NRC acceptance review, the NRC paragraph part of the NRCs acceptance review uses results from the readiness assessment process, is incorrect and misleading. to focus on identified topics, evaluate if The staff does use the readiness changes have been made to specific sections assessment in its acceptance review of the DCA, and confirm the identified topics because issues identified during the from the readiness assessment have been assessment are re-visited and focused adequately addressed for purposes of the on during acceptance review. One of acceptance review.

the key criteria used by the staff during acceptance review is the examination of topics identified during the readiness assessment. A recent example is the NRC readiness assessment of the NuScale DCA. In this case, general and detailed readiness assessment comments were reiterated in the subsequent NRC DCA review schedule letter to NuScale.

19

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

45. C.2.4 Application Acceptance Consistent with comment #42 regarding Industry respectfully suggests additional Disagree: No revision. NRO-REG-100 Review, GUIDANCE, Acceptance readiness assessments, this guidance discussion around the issue of increased references COMDEK Review Process, pg. 43 does not reflect recent experience predictability in acceptance reviews without 0001/COMJSM-07-0001 (ADAMS indicating a dramatic failure of the the significant increase in regulatory burden Accession No. ML071090128) and acceptance review process. The level that recent implementation of NRO-REG-100 associated SRM that confirms that the of assurance being required by the staff has created. technical sufficiency review should has resulted in effectively the first round ensure that the application contains of RAIs occurring during the sufficient information for staff to conduct acceptance review. The escalation in its detailed technical review within a NRO-REG-100 from commence the predictable timeframe.

review to conduct the review has not been sufficiently vetted with industry or with the staff to ensure a consistent understanding of the change in acceptance threshold. The use of high level of certainty that the staff can complete the detailed technical review within a predictable timeframe, while potentially acknowledging industry requests for improved schedule adherence, appears to elevate the desire for schedule certainty above the level of reasonable assurance required for public health and safety.

This was never the industrys intent.

Additionally, recent experience has led to the implication that providing copies of certain references cited in the application is a prerequisite to acceptance of the application, thereby indicating an increase in regulatory burden with no regulatory basis.

20

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

46. C.2.4 Application Acceptance The first paragraph includes For the There should be a single set of review criteria. Agree: Revised to delete the reference to Review, GUIDANCE, Completeness environmental review, the staff has the tables of Reference 58 in DG-1325.

and Sufficiency, pg. 44 developed the Office of New Reactors Environmental Report Acceptance Table 1 of attachment D in NRO-REG-100 Review Tables (Ref.58) as an aid in is just a form with no review criteria. The performing the acceptance review. We review criteria are contained in an understand that the tables provide the environmental acceptance review checklist NRC with a deliverable for the for ESP and COL applications referenced Environmental Report Acceptance NRO-REG-100 which is available in Review that will assist them in ADAMS Accession No.

implementing Office Instruction NRO- ML072250354) The checklist is based on REG-100. The memo transmitting the RG 4.2, Preparation of Environmental tables in March 2016 states that Reports For Nuclear Power Stations, and

[a]pplicants can use these tables to NUREG-1555 which are in the process of perform their own review of their being revised. The staff may update the application before submitting it to the checklist when the revisions to RG 4.2 NRC which should result in fewer (DG-4026 ADAMS Accession No.

acceptance review items being ML1611A068) and NUREG-1555 are identified by the NRC staff. However, completed.

the tables themselves say that [t]he PNNL version of Table 1 [presumably this version of the table] varies somewhat from Table 1 of Attachment D found in the office instruction.

47. C.2.4 Application Acceptance With respect to docketing acceptance The second paragraph should be revised to Disagree: No change. The terminology Review, GUIDANCE, Completeness reviews, DG-1325 defines technical delete the references to improper, used here is not newly created in DG-and Sufficiency, pg. 44 deficiency in the application as including inadequate, or incorrect technical 1325. The staff uses the referenced improper, inadequate, or incorrect information. Instead, DG-1325 should state office instruction, NRO-REG-100, and technical information. Such a definition that a technical deficiency exists if the the definition is attributed to and taken has the tendency to convert the application does not provide the information directly from that office instruction.

acceptance review into a review of the specified in applicable NRC guidance, such as merits of the application. the SRP or DSRS.

48. C.2.5 Application Review and The last sentence should be clarified to Revise to read or within such other time as Agree: Revised.

Requests for Additional Information, reflect current practice when RAIs may be agreed upon between the NRC staff OVERVIEW, pg. 45, 1st paragraph cannot be responded to in 30 days. and the applicant specified by the NRC.

21

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

49. C.2.5 Application Review and The stated intent of RAIs to obtain all 1) Delete all relevant from the 3rd sentence. Agree: Revised as suggested.

Requests for Additional Information, relevant information needed to make a 2) Expand the last sentence of paragraph 2 to OVERVIEW, pg. 45, 2nd paragraph regulatory decision is too broad and read RAIs may address varied regulatory and potentially confusing. technical subject matter as needed to make regulatory decisions on the application.

50. C.2.5 Application Review and While providing courtesy copies of Clarify and replace the last sentence of the first Agree: Revised with some modification.

Requests for Additional Information, certain references for the NRC staffs paragraph as follows: The applicant may Applicants should note that courtesy GUIDANCE, Application Review and convenience might enhance efficiency, consider providing to the staff courtesy copies of copies received by the NRC may RAIs, pg. 46, 1st paragraph industry does not agree that failure to certain references cited in the application, but not become Federal records.

provide what may amount to hundreds readily available. Such courtesy copies are not or thousands of supporting references considered part of the docketed application. The constitutes a lack of transparency. The applicant should be mindful of requirements and proposed language in the last sentence limitations on providing such copies, such as also seems to set an expectation on the copyright restrictions, etc.

part of the staff, as opposed to a recommendation for improved efficiency.

51. C.2.6 Combined License The section on referenced material (i.e., This section should be expanded to include a third Partially agree: It would be inappropriate to Application Referencing a Design secondary references) in an application category of referenced material; i.e., references to incorporate by reference a particular Certification or Early Site Permit, or only discusses material incorporated by information that, in context, are intended to be issue from a secondary reference as Both, GUIDANCE, Material reference, and references for information requirements. In particular, an applicant may not discussed in the recommendation, Referenced, pg. 51 only. It does not address other types of desire to incorporate by reference an entire however, a marked excerpt may be references in applications. document or section of a document, but instead to appropriate in some cases. The applicant treat as a requirement only a particular issue or should be clear regarding what information aspect discussed in a referenced document. This is being treated as a requirement rather may be particularly true with respect to some than for information only.

referenced NRC documents. The context of the discussion of the reference in the application will Revised via the following addition:

indicate whether the information in the reference is intended to be a requirement or for information If an applicant does not wish to only. If a document is merely listed without any incorporate by reference an entire discussion in the application or designation as document or section of a document, but incorporated by reference, the document should instead to treat as a requirement only a be construed as being for information only. particular issue or aspect discussed in a referenced document, the applicant should clearly identify the portion of material to be incorporated by reference.

22

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

52. C.2.6 Combined License The second paragraph states, Provide this note earlier in the RG upon the first Agree: Revised as suggested.

Application Referencing a Design Applicants should note that the terms mention of COL action item, e.g., in C.1.2.

Certification or Early Site Permit, or COL action item and COL information Change the Appendix A example TOC or include Both, GUIDANCE, Combined License item have been used interchangeably; a note reiterating the use of COL action item for Action Items, pg. 53, 2nd paragraph however, this RG uses the term COL consistency in the RG despite the label used in action item for consistency throughout the actual example.

the document. This should be stated earlier, where COL action item is used several times. Also COL information item is used in the Appendix A example table of contents (TOC).

53. C.2.6 Combined License [Editorial] Sentence fragment at the end Correct sentence fragment. Agree: Deleted sentence fragment.

Application Referencing a Design of the first paragraph.

Certification or Early Site Permit, or Both, GUIDANCE, Departures from the Design Certification, pg. 54, 1st paragraph

54. C.2.6 Combined License There are two different SRPs referenced In the 3rd paragraph, insert environmental in Disagree: No change. This references Application Referencing a Design in this section. front of SRP to differentiate from NUREG-0800. the NUREG-0800 that is relevant to a Certification or Early Site Permit, or site safety analysis of an ESP Both, GUIDANCE, Evaluation against application. The environmental SRP the Standard Review Plan and (NUREG-1555, Standard Review Plans Regulatory Guides, Standard Review for Environmental Reviews for Nuclear Plan, pg. 56, 3rd paragraph Power Plants) provides guidance to staff regarding the review of the applicants environmental report used by NRC to develop an Environmental Impact Statement (EIS).

55. C.2.7 Design Center Review The discussion implies the convention Augment the discussion to indicate that specific Agree: Revised as suggested.

Approach, GUIDANCE, Left Margin used in AP1000 constitutes a de facto choice of annotation is up to the DCWG, i.e., may Annotation in Combine License standard. Other design centered vary from examples shown, but should be clear and Applications, pg. 60 working groups (DCWGs) may have an consistent between R-COLA and S-COLAs.

equally effective, but different approach.

23

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

56. C.2.8 Design Acceptance Availability of design information is not Delete sentence. Agree: Change incorporated as Criteria, GUIDANCE, Design a sufficient basis to include the suggested.

Certification Applications, pg. 66, information in the DCD.

sentence after first bullet c.

57. C.2.9 Inspections, Tests, The guidance should indicate that based Include reference to ongoing review and Disagree: No change: NRC continues to Analyses, and Acceptance Criteria, on lessons learned to date, the industry development of NEI 15-02, Industry Guideline for interact with NEI on these issues and pg. 67 et seq. and NRC are engaged in an effort to the Development of Tier 1 and ITAAC under 10 understands that new draft guidance is develop First Principles for the scope of CFR Part 52. likely to submitted for NRC review in lieu Tier 1/ITAAC, as well as standardized of a revision to NEI 15-02.

ITAAC for use by future applicants. It is expected that completion of that effort will lead to an update of RG 1.206 and the applicable sections of the SRP.

58. C.2.9 Inspections, Tests, The first full sentence on the page Revise to state, and analyses are not Agree: Revised as suggested.

Analyses, and Acceptance Criteria, contains awkward and atypical language currently met or will not be met.

OVERVIEW, pg. 68 on the focus of the ITAAC hearing.

59. C.2.9 Inspections, Tests, The DCD is not the same as a design Revise the 5th sentence to state, instead submit Partially agree: Change with modifications.

Analyses, and Acceptance Criteria, certification FSAR. an FSAR with all the information required under The FSAR required under 52.47(a)

GUIDANCE, Requirements for 50.47(a), plus a Tier 1 document of certified represents information that includes both Inspections, Tests, Analyses, and design material, including ITAAC required by information that has been approved (Tier 2)

Acceptance Criteria, Design 50.47(b)(1). and information that has been certified and Certification, pg. 72, 1st paragraph approved (Tier 1). SECY-90-241, clearly indicates that information that is ultimately certified in the rulemaking is a subset of information required as part of the application. Regarding industrys proposed two tier system referenced as Level 3, it states:

In Levels 1 and 2 essentially the entire application will be certified. In Level 3 the design certification will contain much less detail SECY-92-287, Form and Content for a Design Certification Rule (ADAMS 24

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section Accession No. ML003707899), dated August 18, 1992, introduces the term DCD.

Enclosure 2 of SECY-92-287 further states:

The decisions on how to bifurcate the DCD into Tier 1 and Tier 2 are currently part of the ongoing design review process.

Revised text is as follows:

To date, all DC applications were originally submitted and docketed before a 2007 revision of 10 CFR Part 52 and have incorporated by reference a DCD. A DC applicant, however, is currently required to submit an FSAR with all the information required under 10 CFR 52.47(a). A DC applicant must additionally submit ITAAC required by 50.47(b)(1) and may additionally provide any information needed to distinguish certified design material (CDM) from approved material if desired.

Note: Comments 19, 22, 28, 59, 61, and 92 are all related to the question of whether Tier 1 is considered part of the FSAR.

60. C.2.9 Inspections, Tests, The last sentence could be revised to Revise to read, For example, a single ITAAC Agree: Changed as suggested.

Analyses, and Acceptance Criteria, illustrate its point more clearly. that requires verification of the design functions GUIDANCE, Requirements for of multiple motor-operated valves may refer to a Inspections, Tests, Analyses, and specific table listing them.

Acceptance Criteria, Design Certification, pg. 72, 2nd paragraph 25

61. C.2.9 Inspections, Tests, The last sentence states, The applicant To avoid confusion, the guidance should make Disagree: This section refers to a COL Analyses, and Acceptance Criteria, may (1) include the entirety of Tier 1 clear that Tier 1 is not part of the FSAR and thus that references a DC. The existing DCRs GUIDANCE, Requirements for information in Part 8 of the application should be included in Part 8 of the application. state under IV.A.2.a that a COL that Inspections, Tests, Analyses, and or, (2) include the Tier 1 design references the DCR will include a plant-Acceptance Criteria, Combined descriptions, significant interface specific DCD containing the same type of License, pg. 73, last paragraph requirements, and significant site information and using the same parameters in Part 2 of the application organization and numbering as the and provide the ITAAC in Part 8. generic DCD .. as modified and supplemented by the applicant's This paragraph confuses the issue of exemptions and departures.

whether Tier 1 is part of the FSAR. See comment #28. The text has been revised to read as follows:

The COL applicant should include the proposed ITAAC in Part 8 of the COLA. Title 10 CFR 52.80 identifies ITAAC as additional technical information required in the application. Therefore, Part 8 of the COLA containing the ITAAC is not part of the facilitys FSAR. If the COLA references an existing DC, however, the COL applicant should follow Section IV.A.2.a of the applicable 10 CFR Part 52 appendix regarding the organization and numbering of the FSAR, but may include applicable generic ITAAC from the DCD in Part 8 along with site-specific ITAAC.

Note: Comments 19, 22, 28, 59, 61, and 92 are all related to the question of whether Tier 1 is considered part of the FSAR.

26

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

62. C.2.9 Inspections, Tests, Clarification of second sentence. Delete Therefore. Agree: Changed as suggested.

Analyses, and Acceptance Criteria, GUIDANCE, Basis; Format and Content; and Inspections, Tests, Analyses, and Acceptance Criteria Design Descriptions, Inspections, Tests, Analyses, and Acceptance Criteria Basis, pg. 74, 3rd paragraph

63. C.2.9 Inspections, Tests, DG-1325 states that in situ testing, where At a minimum, revise the second sentence to state, Partially agree: First part of change Analyses, and Acceptance Criteria, possible, is the preferred means of In situ testing of the as-built SSCs is the preferred incorporated as suggested.

GUIDANCE, Basis; Format and ITAAC verification. This statement does method of ITAAC verification, but is not required or Content; and Inspections, Tests, not account for testing of modules or expected in all cases. Additional discussion regarding testing of Analyses, and Acceptance Criteria components at the location of modules at a fabrication facility is not Design Descriptions, Inspections, manufacture. This page should be revised to discuss ITAAC incorporated. Performance of ITAAC at a Tests, Analyses, and Acceptance verification of modules or components at the manufacturing facility has not been fully Criteria Format and Content, pg. 75 This should be clarified to make sure location of manufacturing, and should indicate that resolved. Testing of as-built SSCs that applicants understand that other such testing is acceptable provided that remotely is an execution and closure issue forms of ITAAC, including inspection, subsequent fabrication, handling, installation, and and not something that needs to be analyses, type-testing and factory testing do not alter the properties of the module or discussed in a document for providing testing are also acceptable when used component. guidance for submittals.

appropriately.

64. C.2.9 Inspections, Tests, The paragraph following bullet d. should Revise the third sentence to state, failure to Agree: Change incorporated as Analyses, and Acceptance Criteria, be clarified. properly implement the design commitment. suggested.

GUIDANCE, Basis; Format and Content; and Inspections, Tests, Analyses, and Acceptance Criteria Design Descriptions, Inspections, Tests, Analyses, and Acceptance Criteria Format and Content, pg. 75, 6th paragraph 27

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

65. C.2.9 Inspections, Tests, DG-1325 states that ITAAC should These statements should be deleted. Instead, Disagree: No change. This guidance is Analyses, and Acceptance Criteria, address the resolutions of unresolved NRC should adopt NEIs first principles for Tier 1 consistent with the guidance in SRP GUIDANCE, Basis; Format and safety issues, generic safety issues, and ITAAC, which are based upon safety and risk Section 14.3.

Content; and Inspections, Tests, NRC generic correspondence, TMI significance and conformance to NRC regulations.

Analyses, and Acceptance Criteria action plan items, and relevant industry The resolutions of unresolved safety issues, Design Descriptions, Inspections, operating experience. However, not all generic safety issues, NRC generic Tests, Analyses, and Acceptance of that information is safety or risk correspondence, and relevant industry operating Criteria Design Descriptions, pg. 76- significant and therefore does not experience may, but do not necessarily, relate to 77 warrant treatment in an ITAAC. any matter that is safety or risk significant or

66. C.2.9 Inspections, Tests, Ana This portion of DG-1325 provides a Modify bullet g. on page 77 to reflect that ITAAC Agree: Modified to address NEI comment.

lyses, and Acceptance Criteria, description of the scope of the design are not required on all regulations in Parts 20, 73 GUIDANCE, Basis; Format and that is considered top-level design and 100, unless they specify requirements related Content; and Inspections, Tests, information and should be selected for to performance of safety-related or risk significant Analyses, and Acceptance Criteria verification by the ITAAC. However, not functions.

Design Descriptions, Inspections, all of the criteria are consistent with NRC Tests, Analyses, and Acceptance policy established through several NRC Criteria Design Descriptions, pg. 76- SECY papers published since the early 77, 2nd paragraph, list, and following 1990s. There are also several criteria for paragraph establishing ITAAC that are not included in the draft regulatory guide. For example, there does not need to be an ITAAC for every regulation in 10 CFR Part 20.

NRC SECYs have discussed that regulations such as 10 CFR 20.1406 on minimization of contamination that do not specify requirements related to performance of safety-related or risk significant functions do not require an ITAAC, which is reinforced by the fact that previously approved DCDs do not include an ITAAC for this requirement.

28

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

67. C.2.9 Inspections, Tests, ITAAC may be inspection, analyses, Delete item f. Disagree: Section 14.3 of the SRP Analyses, and Acceptance Criteria, type-testing and factory testing and identifies in-situ testing as the preferred GUIDANCE, Basis; Format and therefore saying that applicants should method of verification and the RG uses the Content; and Inspections, Tests, Ensure that ITAAC emphasize testing of term emphasize which is appropriate to Analyses, and Acceptance Criteria the as-built facility is incorrect or at least denote this preferability.

Design Descriptions, Inspections, misleading.

Tests, Analyses, and Acceptance Criteria Design Descriptions, pg. 77, item f.

68. C.2.9 Inspections, Tests, Item i. is SRP Section 14.3.10, An additional discussion related to site specific Agree: Inserted table format for EP Analyses, and Acceptance Criteria, Emergency Planning ITAAC. Generic ITAAC should be provided in this section of the ITAAC with reference to SRP Section GUIDANCE, Basis; Format and emergency planning ITAAC do not follow RG. 14.3.10.

Content; and Inspections, Tests, the format guidance provided above. An Analyses, and Acceptance Criteria additional discussion related to site Design Descriptions, Inspections, specific ITAAC should be provided in the Tests, Analyses, and Acceptance RG.

Criteria Design Descriptions, pg. 78, item i.

69. C.2.11 COL Action Items and [Editorial] Postlicense should be hyphenated, i.e., post- Agree: Changed throughout.

Postlicense Commitments, pg. 79 et license throughout.

seq.

70. C.2.11 COL Action Items and [Editorial] Delete double use of Successful completion of Agree: Corrected.

Postlicense Commitments, in the last sentence of second paragraph.

GUIDANCE, Combined License Action Items that Cannot Be Resolved before Issuance of a License, Inspections, Tests, Analyses, and Acceptance Criteria, pg. 82 29

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

71. C.2.11 COL Action Items and [Editorial] Correct 2424 to 24 in the 3rd sentence. Agree: Corrected.

Postlicense Commitments, GUIDANCE, Combined License Action Items that Cannot Be Resolved before Issuance of a License, Final Safety Analysis Report Commitments, Final Safety Analysis Report Information Commitment Included in a License Condition, pg. 83

72. C.2.11 COL Action Items and The paragraph following the bullets Delete paragraph. Agree: Revised as suggested.

Postlicense Commitments, seems to suggest the expectation for GUIDANCE, Combined License one or more FSAR updates outside of Action Items that Cannot Be Resolved the annual FSAR update requirement of before Issuance of a License, Final 50.71(e)(3)(iii), i.e., prior to fuel load, Safety Analysis Report Commitments, initial criticality, and exceedance of 5%

Final Safety Analysis Report power. This paragraph is unnecessary, Information Commitment Included in a conflicts with FSAR update License Condition, pg. 84 requirements, and should be deleted.

73. C.2.11 COL Action Items and The last paragraph of C.2.11 Relocate the last paragraph of C.2.11 to the end Agree: Revised as suggested.

Postlicense Commitments, concerns use of a license condition of the subsection titled, FSAR Information GUIDANCE, Combined License and belongs in the previous Commitment Included in a License Condition.

Action Items that Cannot Be Resolved subsection.

before Issuance of a License, Final Safety Analysis Report Commitments, Final SAR Information Commitments Included in a Routine Final SAR Update, pg. 85

74. C.2.12 Operational Programs for [Editorial] Add punctuation to the first paragraph. Agree: Corrected.

Combined Licenses, OVERVIEW, pg. 85

75. C.2.12 Operational Programs for NRC does not inspect operational Revise bullet c to state, The NRC staff inspects Agree: Revised.

Combined Licenses, OVERVIEW, programs before issuing a license. these programs prior to operation before issuing a pg. 85, bullet c. license .

30

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

76. C.2.12 Operational Programs for The guidance in the first two sentences Revise the guidance to be clear that when Agree: Revised as recommended.

Combined Licenses, GUIDANCE, seems to be at odds. The first sentence incorporating by reference a generic License Conditions, Operation al acknowledges that COL applicants may operational program, the COL applicant adds Program Options, pg. 87 incorporate by reference a generic some plant- specific details as appropriate in operational program, but the next addition to implementation milestones.

sentences seems to defeat the purpose Language similar to that in the second of referencing the generic operational paragraph would be clearer, e.g., the program because then the applicant expectation to fully describe the program would (not may) submit to the NRC would met by a COL applicant that references the plant-specific operational program an approved generic operational program description and adds plant-specific details as appropriate.

77. C.2.13 10 CFR Parts 30, 40, and These discussions cite requirements for Clarify areas where information is needed for Agree: Text revised as 70 Materials Licenses for Combined inclusion from NUREG-1520 and materials licenses that has not already been recommended.

Licenses, GUIDANCE, Application NUREG-1556, but do not acknowledge provided in the COLA.

Information for a 10 CFR Part 70 and that the vast majority of this information is Parts 30 and 40 Licenses also required for a COLA under Parts 52 and 50.

78. C.2.14 Information Change This section uses the term changes Correct references to changes to DC Agree: Revised and clarified the use of Processes for Combined License when it should use the term information and changes to Tier 1, Tier 2, or the terms change, departures, and Applicants, pg. 93 et seq. departures. Applicants can depart from Tier 2*. variances in the Overview and initial a design certification but cannot change paragraphs of the Guidance a DC. subsections. This regulatory topic is on change processes for COL applicants, and thus the term change, as used in the existing DCD, is appropriate once explained.

31

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

79. C.2.14 Information Change It is fortunate that the update of RG 1.206 Revise the guidance to clarify that going forward Agree: Revised text as suggested.

Processes for Combined License spans the period during which the NRC the focus will be on clearly determining the scope Additional text changes were made Applicants, GUIDANCE, Combined has revisited the use of Tier 2* in design of Tier 1 information versus Tier 2 and that NRC based on SECY-17-0075 to more License Application Referencing a certifications. As discussed in a letter staff will no longer identify certain Tier 2 accurately reflect the history and the Design Certification, pg. 94- 97 dated December 12, 2014, the industry information to be designated Tier 2*. Rather, the flexibility associated with Tier 2*

recommends discontinuing the use of applicant will be given the option to self-designate information in the existing DCRs.

Tier 2* for current and future design certain information as Tier 2* that otherwise may certifications. have been included in Tier 1.

While the staff has indicated that they are not prepared to go that far, we

80. C.2.14 Information Change It would be helpful to provide an Provide an example of an operational program that Agree: Deleted referenced sentence.

Processes for Combined License example of an operational program that is fully described and approved in the generic Operational programs are generally not Applicants, GUIDANCE, Combined is fully described and approved in the DCD. approved in a generic DCD.

License Application Referencing a generic DCD.

Design Certification, Change s to Operational Requirements, pg. 97

81. C.2.15 Environmental Issue Good discussion on new and Provide guidance indicating that, in the absence of Agree: Provided guidance as Finality for Combined License significant, but no information regarding new and significant information or other influencing recommended in the second paragraph Applicants, GUIDANCE, Finality of the staffs view of the shelf life of site factors, site characterization information in an ESP after the subheading entitled Finality of Environmental Issues Associated with characterization information. can be considered valid to a COLA submitted prior Environmental Issues Associated with an an Early Site Permit, pg. 99 et seq. to the expiration of the ESP. Early Site Permit.

82. C.2.16 Finalizing Licensing- The first full paragraph contains a sentence Revise to read or within such other time as Agree: Revised as recommended.

Basis Information, GUIDANCE, that should be clarified to reflect current may be agreed upon between the NRC staff and General Guidance, pg. 102 practice when RAIs cannot be responded to the applicant specified by the NRC.

in 30 days.

83. C.2.16 Finalizing Licensing- COL applicants and licensees and Delete the majority of from sentence 4. Agree: Revised as recommended.

Basis Information, GUIDANCE, DC vendors will use established General Guidance, pg. 102, last full change control processes to manage paragraph all changes identified after the freeze point.

84. C.2.16 Finalizing Licensing-Basis Clarification Revise sentence 2 to read, unless they are Agree: Revised as recommended.

Information, GUIDANCE, Finalizing proposed by a license applicant or licensee as Licensing-Basis Information for departures .

Design Certifications, pg. 103 32

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

85. C.2.16 Finalizing Licensing-Basis [Editorial] Revise sentence 3 to state, an update to a Agree: Revised.

Information, GUIDANCE, Finalizing COLA, or in a periodic report.

Licensing-Basis Information for Design Certifications, pg. 103

86. C.2.16 Finalizing Licensing-Basis The first paragraph under Finalizing Delete the top two paragraphs on page 104. Partially agree: Partial revision. The Information, GUIDANCE, Finalizing Licensing-Basis Information for Design guidance is correct and relevant but has Licensing-Basis Information for Certifications (on pg. 103) is adequate been simplified by excluding discussion Design Certifications, pg. 104 and the two following paragraphs are of COL applicant options during the unnecessary and potentially confusing revision or renewal of a DC.

with respect to DC renewal. The top paragraph on p. 104 could be misinterpreted to suggest that the renewed DC has an impact on a COL applicant that incorporated by reference a prior revision of the DC. Unlike a DC amendment, DC renewal does not impact existing applicants or licensees that incorporate by reference a prior revision of the DC. It is unnecessary and confusing to discuss renewal in connection with freeze point.

87. C.2.16 Finalizing Licensing-Basis DG-1325 states that significant DCD This section of C.2.16 should be deleted because Disagree: No revision made. The Information, GUIDANCE, Errors in errors must be corrected prior to it is premature to address this issue in the content of the DG provides current Design Certifications Referenced by issuance of a COL. That position has pending revision of RG 1.206 while the industry guidance and is factually correct.

Combined License Applications, resulted and could continue to result in and NRC are still in discussions to resolve it.

pg. 104-105 significant delays in issuance of COLs. Section C.2.16 should later be revised to reflect Further, it is premature to address this the outcome of ongoing discussions, e.g., other issue in the pending revision of alternatives that assure safety without unduly RG 1.206 while the industry and NRC delaying issuance of a COL.

are still in discussions to resolve the issue. Reference NEIs letter to NRC dated August 4, 2017, Avoiding Delays in Issuance of NRC Combined Licenses due to Design Certification Errors.

33

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section

88. C.2.17 Small Modular Reactors The discussion here implies a DSRS is Clarify DSRSs may be used for other types of Agree: Minor revision to clarify the and Design- Specific Review somehow unique to an SMR, when in reactor designs as well and is strictly optional. applicability of DSRS to applications Standards, pg. 105 et seq. fact the use of DSRSs for SMRs was other than LWR SMR and staffs ESFRA largely a matter of timing of applications. Inform the discussion based on staff and industry which is presented in Section C.2.1 and assessment of the questionable efficacy of prior referenced in Section C.2.17.

Also, the use of DSRSs for mPower and DSRS development and use.

NuScale is thought to have had mixed results; has this discussion been informed by a review of those outcomes?

89. C.2.17 Small Modular Reactors [Editorial] Revise the first sentence to state, Partially agree: No change based on and Design- Specific Review approaches that the staff finds has found first recommendation. The SRP reflects Standards, OVERVIEW, Standard acceptable. approaches that have been found Review Plan and Design-Specific acceptable in previous reviews.

Review Standards, pg. 106 Revise first sentence of 2nd paragraph to state, Each DSRS has the same objectives as that Revised according to second the SRP has for non-SMR application reviews. recommendation.

90. C.2.18 Limited Work [Editorial] For longevity of this RG 1.206 Revise first sentence of paragraph 4 to state, Agree: Changed as recommended.

Authorization, OVERVIEW, pg. 110, revision, strike recently in the first The NRC recently issued an LWA .

4th paragraph sentence of the 4th paragraph.

91. C.2.18 Limited Work The requirements for COL ITAAC are Delete item c on p. 111. Disagree: No change. ITAAC is applicable Authorization, GUIDANCE, covered outside of 10 CFR 50.10 and to LWA. 10 CFR 50.10(d)(3) states the Applications, pg. 111 should not be included in the first list on following and includes the underlined text page 111. which could include ITAAC:

The application must include:

(i) A safety analysis report required by 10 CFR 50.34, 10 CFR 52.17 or 10 CFR 52.79 of this chapter, as applicable, a description of the activities requested to be performed, and the design and construction information otherwise required by the Commission's rules and regulations to be submitted for a construction permit or combined license, but limited to those portions of the facility that are within the scope of the limited work 34

Comment Number/Affected Comment/Basis Recommendation NRC Staff Disposition and Resolution Section authorization. The safety analysis report must demonstrate that activities conducted under the limited work authorization will be conducted in compliance with the technically-relevant Commission requirements in 10 CFR Chapter I applicable to the design of those portions of the facility within the scope of the limited work authorization;

92. Appendix A, pg. A-1 The title of this appendix states: Revise the title so it is clear that Tier 1 of the DCD Disagree: Change with modifications.

is not considered part of the FSAR. Revised text to indicate that content EXAMPLE TABLE OF CONTENTS comes from a DCD that contains Tier 1 FOR DESIGN CERTIFICATION and Tier 2 information. NRC staff APPLICATION FINAL SAFETY however disagrees that Tier 1 ANALYSIS REPORT information, other than ITAAC, of the DCD would not be considered part of the The title conflicts with the requirements for materials required under 10 CFR 52.47(a) contents of a FSAR as specified in Part associated with a DC FSAR. For the

52. Per 10 CFR 52.47(a), Tier 1 case of 10 CFR 52 Appendix D, Tier 1 information is not required to be included information includes both ITAAC required in the FSAR. under 10 52.47 (b) as well as design descriptions required under 10 52.47(a).

Note: Comments 19, 22, 28, 59, 61, and 92 are all related to the question of whether Tier 1 is considered part of the FSAR.

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