ML20349A336

Public Comment Resolution Table for DG-1321

ML20349A336
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Issue date:	02/28/2021
From:	Office of Nuclear Regulatory Research
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ML20349A337	List: ML20349A335 ML20349A336 ML20349A344 ML21096A058 ML21096A062 ML21096A063 ML21096A064
References
DG-1321, RG-1.237
Download: ML20349A336 (15)

Text

February 2021 Response to Public Comments on Draft Regulatory Guide (DG)-1321 Guidance for Changes During Construction for New Nuclear Power Plants Being Constructed Under a Combined License Referencing a Certified DesignUnder 10 CFR Part 52 New Regulatory Guide (RG) 1.237 On May 5, 2020, the NRC published a notice in the Federal Register (85 FR 26725) that Draft Regulatory Guide, DG-1321, was available for public comment. The Public Comment period ended on July 6, 2020. The NRC received comments from the organizations listed below. The NRC has combined the comments and NRC responses in the following table.

Comments were received from the following:

Marcus R. Nichol Nuclear Energy Institute (NEI) 1201 F Street, NW, Suite 1100 Washington DC 20004 ADAMS Accession No. ML20189A572 Mike Tschiltz Nuclear Energy Institute (NEI) 1201 F Street, NW, Suite 1100 Washington DC 20004 ADAMS Accession No. ML20141L506 ADAMS Accession No. ML20141L501 Gary Becker NuScale Power, LLC 6650 SW Redwood Ln #210 Portland, OR, 97224 ADAMS Accession No. ML20189A574 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 1

Marcus Nichol, NEI General (a) The draft guidance provides a process for proceeding with construction for departures from Tier 2 information that require an amendment but precludes changes to Tier 1 and is silent on departures from Tier 2* information. While it is likely that this process is also intended to be applicable to Tier 2* information (Tier 2* is defined as a subset of Tier 2 in the Part 52 (a) The NRC staff agrees with the comment. The guidance applies to Tier 2, which includes Tier 2*.

To leave no doubt, the NRC staff modified the DG to explicitly include Tier 2* information as subject to the guidance. To clarify this issue, the staff added the following text in Section C of DG-1321 For the staffs positions articulated below Tier 2 includes Tier 2*. The staff notes that the comment is also

2 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution Appendix D, for example), this should be explicitly stated in the DG.

(b) The draft guidance does not take the opportunity to provide a more efficient change process for Part 50 SSAR and PSAR and defaults to the use of license amendments for any changes.

correct in stating that the guidance does not apply to Tier 1 information.

(b) The NRC staff disagrees with the comment. As clearly stated in the purpose and applicability of the DG, the NRC staff intended the guidance in DG-1321 to apply to combined licenses under Part 52, and not construction permits (CPs) or early site permits (ESPs). Holders of CPs have well-established change processes and agency guidance during construction or changes to a facility, and ESPs do not authorize facility construction. Neither CPs nor ESPs are within the scope of this DG. The NRC staff did not make any changes to the DG in response to this comment.

2 Marcus Nichol, NEI Applicable Regulations

- 10 CFR Part 52, Appendices A, B, C, D, E,

and F (pg. 2)

Editorial comment: DCD is the abbreviation for design control document, not design certification document.

The NRC staff agrees with the comment and has changed the DG to refer to DCD as design control document.

3 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 3

Marcus Nichol, NEI Related Guidance (pg. 3)

(a) NEI 96-07 Appendix C isnt yet endorsed in NRC guidance; however, it is approved for use by NRC letter. Recommend including this guidance in the list of Related Guidance.

(b) RG 1.215 may also be appropriate to discuss here since this proposed approach impacts the timing of ITAAC correspondence and also endorses NEI 08-01 as an acceptable method for performing ITAAC closure.

(a) The NRC staff agrees with the comment and has added NEI 96-07 Appendix C to the Related Guidance section of the DG. However, this Regulatory Guide does not endorse NEI 96-07 Appendix C.

(b) The NRC staff agrees with the comment and has added RG 1.215, Guidance for ITAAC Closure Under 10 CFR Part 52, into the Related Guidance section of the DG, as it provides guidance on the closure of ITAAC under 10 CFR Part 52.

However, the NRC staff believes that a late licensee submittal or amendment request could impact the ITAAC schedule because the NRC staff requires sufficient time to review an amendment. No further changes to the DG are necessary.

4 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 4

Marcus Nichol, NEI Related Guidance (pg. 3)

NEI is advocating changes to DG-1321 that would obviate the need for the preliminary amendment request (PAR) process described in COL-ISG-025.

If those changes are not implemented by the staff, then COL-ISG-025 guidance should be incorporated into DG-1321 to maintain flexibility in addressing changes during construction via the PAR process.

The NRC staff disagrees with the comment because the basis for DG-1321 does not support a mechanism to govern departures from Tier 1. Because COL-ISG-025 (ADAMS Accession No. ML ML15058A377) provides guidance on changes during construction, which is also the subject of DG-1321, the comment understandably suggests incorporating the guidance in COL-ISG-025 into DG-1321. Because the NRC staff plans to leave the guidance in COL-ISG-025 in place, there is no need to incorporate it into RG 1.237 in order to maintain licensee flexibility. The NRC staff has therefore decided not to pursue the incorporation of the ISG into DG-1321 and subsequently retiring COL-ISG-025.

The NRC staff has made no changes to the DG as a result of this comment.

5 Marcus Nichol, NEI Basis for the Changes in Guidance (pg. 6)

Since this seems to imply that the Quality Assurance Program is a key part to the success of this program, perhaps RG 1.28 should also be inserted into the Related Guidance section since NQA-1 guidance provides some helpful information about Conditional Release in Subpart 2.2 in support of Basic Requirement 15. However, this would not address SSCs in the licensing basis not covered under the QA program.

The NRC staff agrees with the comment and has added RG 1.28, Quality Assurance Program Criteria (Design and Construction), to the Related Guidance section of the DG as it provides guidance on both Part 1 and Part 2 of the American Society of Mechanical Engineers standard NQA-1.

5 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 6

Marcus Nichol, NEI Basis for Changes in Guidance (pg. 7)

The draft guidance provides very limited benefit to most Part 52 licensees due to the lack of applicability to changes to Tier 1 information, which is the basis for the majority of the Part 52 LARs. For Vogtle 3&4, the need for Tier 2* LARs was minimized by Amendment Nos. 142 and 141, which provide a site-specific Tier 2* Departure Evaluation Process. For design certifications currently under review, the amount of Tier 2*

information is expected to be minimized or eliminated entirely.

It is stated that the basis for omitting Tier 1 from the DG process is that it is based upon the 1999 rule amending 50.59, which corresponds to the change process for Tier 2 information. However, by definition, Tier 1 information is derived from Tier 2. Therefore, it is logical that the guidance be expanded to encompass LARs requesting departures from Tier 1 information. It is understood that while an expansion in scope to include Tier 1 would involve justification in the LAR, such a change would allow licensees to obtain much of the benefit envisioned by this guidance.

The NRC staff disagrees with the comment to the extent the comment suggests that the NRC could use this guidance to afford additional flexibility to a COL holder for departures from Tier 1. DG-1321, if issued as final Regulatory Guide, cannot change the treatment of Tier 1 because Tier 1 is a set of design-specific regulations incorporated into every Appendix to Part 52 that certifies a standard design, and a COL holder must obtain an exemption in order to implement a proposed departure from an individual Tier 1 requirement. In that regard, Tier 1 differs from Tier 2 (including Tier 2*) because an exemption is not required to depart from Tier 2.

Specifically, for Tier 2, each Part 52 design certification appendix imposes Tier 2 as a set of requirements through text in Section II.E and III.B, but allows changes in accordance with Section VIII.B. Accordingly, an interpretive rule in guidance can allow a COL holder to treat Tier 2 information as it would treat FSAR information under Part 50, provided the COL holder obtains exemptions from

§§ II.E and III.B in the applicable Part 52 design certification appendix and an amendment to augment the change control processes in design certification appendix section VIII.

The NRC staff did not make any changes to the DG in response to this comment.

6 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 7

Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 1.a (pg.

8)

Similar to the previous comment, this language limits the scope of the changes to a change to the facility or departure from Tier 2 of the plant-specific DCD. This text precludes changes to Technical Specifications or Tier 1 that may not impact Tier 2.

For changes to Tier 1, licensees need to follow NRCs exemption request procedures. To add clarity regarding Technical Specifications, the staff has added Technical Specifications to Items 1.a. and 1.b.

in Section C of DG-1321.

8 Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 1.a (pg.

8)

The SOC for the 1999 change to the 50.59 rule did not require this 45-day precondition. It is not clear why it is necessary for Part 52 COL holders.

Delays to fuel load are the licensees risks.

Also, it is not clear what happens if there is a delay and the submittal isn't made until day 49 or 50, for example.

Perhaps it would be better to state:

The licensee should submit a request for a license amendment in sufficient time to allow for NRC review and approval without delaying the schedule for making ITAAC findings or authorizing fuel load.

or simply replace within 45 days with (typically within 45 days) "

The NRC staff disagrees with this comment as follows. For changes under 10 CFR 50.59, a licensee of the operating facility has the incentive to submit the amendment to avoid delays from restart from an outage. However, in contrast, under 10 CFR Part 52, the NRC has a regulatory interest in ensuring the NRC staff has sufficient time to review any necessary amendments before the licensee completes the work necessary in order to submit ITAAC closure letters. The tasks necessary to review an amendment request include establishing review schedules, allocating resources, planning inspections, and avoiding bottlenecks as construction nears completion. That is why DG-1321 specifies the need for the 45 day condition. The NRC staff did not change the DG in response to this comment.

7 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 9

Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 1.b (pg.

8)

(a) The SOC for the 1999 change to the 50.59 rule did not require this precondition. Why is it necessary for Part 52 COL holders? The basis is not clear. Again, this text omits a change to Technical Specifications or Tier 1 where the change may not impact Tier 2.

(b) Regarding the proposed changes to SSCs in the restricted area, as defined in Part 20, this appears to be referring to one of the aspects of the PAR Process whereby the NRC verified that the change qualified for a categorical exclusion from having to perform an environmental review. If that is the case, then this point should be clearly explained in the DG.

(a). Under NEPA, the NRC is required to ensure that federal actions do not result in the irreversible or irretrievable commitment of environmental resources prior to conducting an appropriate environmental review. In order to fulfill NRC obligations, the staff would need to evaluate any proposed change during construction prior to implementation. Thus, Item 1.b is necessary for Part 52 to ensure that the design change qualifies for a categorical exclusion and NRC environmental review is not necessary. The NRC staff did not change the DG in response to this comment.

(b) The NRC staff agrees with this comment and modified DG-1321 by adding the following text to Section C, Item 1.b., This ensures that the change qualifies for a categorical exclusion and NRC environmental review is not necessary.

10 Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 1.d (pg.

8)

This text does not include situations in which the departure affects Tech Specs or the License. (This might also impact item no. 4 which addresses only Tier 1 and ITAAC. Perhaps it should also address the rest of the license, i.e., license conditions and Tech Specs.)

The NRC staff agrees with the comment in part. The DG has been updated to add Technical Specification to Items 1.a. and 1.b. in Section C of DG-1321. The Technical Specifications are part of the license, which includes, for example, the applicable regulations, orders, and any site-specific requirements. Thus, changes to license conditions and other changes that do not impact construction are not covered by RG 1.237, and RG 1.237 need not specifically refer to the license..

8 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 11 Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 3 (pg.

8)

This text seems to imply that changes to ITAAC (Tier 1) are within the scope of this guidance.

There appears to be inconsistencies in the language used to describe the guidance scope.

Language from DG related to the comment:

Although all COLs issued as of the date of this RG include a license condition authorizing PARs, a licensee has the option to use the guidance provided in this RG (and the provisions of its license condition) for a change to or departure from the design of the facility that requires a license amendment and any associated exemption from the certification information.

The NRC staff agrees with comment and provided clarification to the DG. Changes to ITAAC are not within the scope of DG-1321. Therefore, the NRC staff deleted and any associated exemption from the certification information. from Section C, Item 3 of DG-1321.

12 Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 5 (pg.

9)

For a license applicant who does not reference a certified design, is it the NRCs position that this license condition would still be required based on the applicability of the RG proposed here? Would a license applicant in this situation only need to add a license condition to not submit an ITAAC Closure Notification until the LAR impacting the related UFSAR or ITAAC language was approved (because Tier 1/Tier 2 dont exist in that situation)? Clarification is needed.

Language from DG related to the comment:

To voluntarily adopt this process, a licensee should propose a license condition that implements the conditions in Items 1 and 2 above and exemptions from the applicable provisions of section II.E and III.B of the Part 52 design certification appendix referenced in the COL.

The NRC staff agrees with the comment and decided to take Section 52.98(b) out of the Purpose in Section A of DG-1321. In addition the staff has narrowed the focus of the applicability of the DG-1321 to only apply to COLs issued under 10 CFR Part 52 that reference a certified design, which is governed by § 52.98(c).

9 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 13 Marcus Nichol, NEI C. Staff Regulatory Guidance -

Item 5 (pg.

9)

On page 7, it states that The foregoing background and discussion applies only to the design of a facility described in an FSAR, as updated, including Tier 2, but not Tier 1, as described below.

The exemptions to which C.5 is referring are unclear. Is this text referring to exemptions to allow the process described in the license condition to be used, or is it referring to specific exemptions to allow changes to be made to certified information? Are the referenced exemptions intended to allow the licensee to forego seeking a PAR No Objection and instead utilize this new license condition to proceed with construction without submittal of the LAR and NRC acceptance of the LAR in situations where Tier 1 is involved? If this is the case, then guidance for PARs is not necessary. Clarification is needed.

The NRC staff understands the comment. This text is referring to exemptions to allow the process described in the license condition to be used.

The referenced exemptions are not intended to allow the licensee to forego seeking a Preliminary Amendment Request (PAR) No Objection for Tier 1 departures.

The exemptions mentioned in Section C, Item 5 of DG-1321 are referring to exemptions from Part 52 sections II.E and III.B not exemptions to Tier 1.

The staff added, propose before the word exemptions in Item 5 of Section C.

14 Marcus Nichol, NEI FRN Section IV More discussion is needed with the industry to get a better understanding of what is under consideration for inclusion in the DG regarding timing and review of license amendments between the section 52.103(a) notice and 52.103(g) finding.

The NRC staff agrees with the comment in part; however, these issues are beyond the intended scope of the DG. The NRC staff would welcome additional discussions with all stakeholders in order to further develop guidance and lessons learned related to the timing of license amendments after the publication of a 10 CFR 52.103(a) notice and a 10 CFR 52.103(g) finding. The NRC staff did not make any changes to the DG as a result of this comment.

10 15 NuScale General (a) The Purpose, Applicability, and Applicable Regulations indicate that the guidance is applicable to all COL holders, including those that reference a Standard Design Approval (SDA) or do not reference a prior approval (i.e., a "custom COL"). However, the Background and Staff Regulatory Guidance focus exclusively on COLs that reference a certified design, including a proscription on applying the new approach to departures from Tier 1 information. COLs that do not reference a certified design, including those that reference an SDA, will not have Tier 1 information. As such, the entirety of the FSAR for such a COL would be subject only to the change processes of Part 50, such as 10 CFR 50.59, as provided by 10 CFR 52.98(b). Thus, with the exception of changes affecting an ITAAC which are subject to an LAR a COL holder not referencing a certified design would seem capable of constructing SSCs at risk for any part of the design. This aspect of the guidance should be clearly stated.

(b) Further, this distinction underscores the comments of the Nuclear Energy Institute, who in their July 1, 2020 letter explained that there is no regulatory or safety basis to exclude Tier 1 from changes during construction without NRC approval. DG-1321 asserts that because the change process for Tier 2 information is analogous to that of 10 CFR 50.59, therefore the rationale of the 10 CFR 50.59 Statements of Consideration ("SOC")

used to develop the guidance is limited to Tier 2 information. However, that a change is not "implemented" until the SSC is placed into service (in the case of COL construction, the associated (a) The NRC staff partially agrees with comment and decided to narrow the focus of the applicability of DG-1321 to COLs issued under 10 CFR Part 52 that reference a certified design, which are covered by 10 CFR 52.98(c). Accordingly, the staff deleted reference to Section 52.98(b) from the purpose paragraph in Section A of the DG-1321..

(b) The NRC staff disagrees with the comment to the extent the comment suggests that the NRC could use guidance to afford additional flexibility to a COL holder for departures from Tier 1. DG-1321, if issued as final Regulatory Guide, cannot change the treatment of Tier 1 because Tier 1 is a set of design-specific regulations incorporated into every Appendix to Part 52 that certifies a standard design.

A COL holder must obtain an exemption in order to implement a proposed departure from an individual Tier 1 requirement, as guidance cannot override a rule. See response to Comment 6 for additional information. The NRC staff did not make any changes to the DG as a result of this comment.

11 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution ITAAC performed) applies equally to Tier 1 or Tier 2 information. 10 CFR 50.59 allows certain changes to be made without NRC approval; For those that require approval, construction is permissible prior to approval. That same approach should follow for either Tier 1 or Tier 2 departures, as well as COLs that do not have tiered information (i.e., those that do not reference a design certification).

16 NuScale General Staff's position 1.a states that a "licensee must submit the request for a license amendment required to authorize the change to the facility or departure from Tier 2 of the plant-specific DCD within 45 days after the licensee begins construction of the SSCs subject to the change or departure." It is unclear why a 45 day time limit is necessary, given that sufficient time to process the LAR would depend on where in the construction process the change or departure occurs, and any delay to ITAAC findings would be the licensee's risk. Regardless, should a deadline remain, it should be tied to construction of the change itself rather than "construction of the SSCs subject to the change." An SSC (e.g., a building) could be under construction for a significant time prior to a change from the FSAR description for some portion of that SSC being identified as necessary.

As discussed in Comment 8, the NRC has a regulatory interest in ensuring the NRC staff has sufficient time to review any necessary amendments before the licensee completes the work necessary in order to submit ITAAC closure letters. That is why DG-1321 specifies the need for the 45 day condition.

The staff agrees with the comment in part, but the schedule for LAR submission should run from the time the licensee has approved the design package for the SSC as changed and construction of the SSC has begun. The NRC staff modified the text in Position 1.a to reflect this view in response to this comment.

12 17 NuScale General Staff's position 5 states "To voluntarily adopt this process, a licensee should propose a license condition that implements the conditions in Items 1 and 2 above and exemptions from the applicable provisions of sections II.E and III.B of the Part 52 design certification appendix referenced in the COL." It is unclear what license condition is necessary to implement the guidance and why. As Staff's basis is that a change is not implemented until ITAAC are performed, constructing the change prior to NRC approval does not seem to necessitate a license condition or exemption from a design certification appendix (if a design certification is referenced). A Part 50 licensee does not need a license condition construct changes as described in the 10 CFR 50.59 SOC. Please explain what license condition and exemptions are needed.

The NRC staff understands the comment. As a preliminary matter, the NRC staff has decided, in response to other comments, to limit the guidance to changes during construction under a COL that references a certified design. The response below addresses a COL that references a certified design.

Each Part 52 appendix that certifies a standard design includes a provision in § II.E that states

[c]ompliance with Tier 2 is required[.] (Section III.B of each Part 52 design certification appendix reiterates this provision.) Because § II.E defines Tier 2 as a set of requirements, it fundamentally differs from a FSAR under Part 50. Accordingly, the process for changes during construction under a COL that reference a certified design as proposed in the new guidance requires exemptions from §§ II.E and III.B.

Section II.Ealso provides an exception to its requirement to comply with Tier 2. Namely, the

§ VIII.B process allows for making generic changes or taking certain plant-specific departures from Tier 2, which allows licensees to implement some departures without prior NRC approval. In this regard, § II.E allows for regulatory control over Tier 2 similar, but not identical to, NRC control over a Part 50 FSAR under 10 CFR 50.59. In short, exemptions from §§ II.E and III.B of the applicable design certification appendix are needed to allow a COL holder to depart from Tier 2, including Tier 2*,

without complying with § VIII.B.5 of that appendix.

As for the license condition, it is necessary for the NRC to maintain regulatory stability and discharge its duties. For example, Condition C.1.d in the

13 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution guidance would require a licensee to perform an evaluation with respect to Tier 1 currently required by § VIII.B.5.a. Because the guidance would allow departures from Tier 2 before the licensee submits a required amendment, a licensee might not perform the evaluation required by § VIII.B.5.a before starting construction. In the absence of such an evaluation, a licensee might construct an SSC that does not comply with Tier 2 and only later determine that the construction also does not comply with Tier 1. Under the current process, § VIII.B.5.a requires that evaluation before construction starts; the new license condition would maintain the requirement for a pre-construction evaluation. The other conditions in the guidance likewise maintain NRC control over Tier 2 or maintain regulatory stability.

The license condition provides the means to allow the licensee to construct in an at-risk manner that is not consistent with the approved design and before the submittal or approval of a final LAR. A license condition is needed to specify a procedure governing changes to Tier 2, including Tier 2*, other than defined in Section VIII.B.5 of the applicable design certification appendix to Part 52.

The NRC staff did not change the DG in response to this comment.

14 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 18 Michael

Tschiltz, NEI FRN I am aware of meetings with the staff has had with Southern concerning a streamlined LAR process during construction, since emergency/exigent LARs are not applicable under construction. But it is unclear exactly what the staff is considering in the FRN. Is the staff considering whether the current ISG-025 process should still be applicable during the period from the Notice of Intended Operations to 103(g)

The NRC staff agrees with the comment and the current COL-ISG-025 process should still be applicable during the period from the Notice of Intended Operations unless and until the NRC makes a finding under 10 CFR 52.103(g). The NRC staff did not change the DG in response to this comment.

19 Michael

Tschiltz, NEI General (a) DG-1321 seems to only cover a small subset of what the industry was requesting in its report that shows that there were a number of changes to Tier 1 and Tier 2* that created challenges. Not sure why Tier 2* isnt addressed in the DG.

(b) Also it is not clear why minor clerical corrections to Tier 1 information is excluded from the process. Without the additional relief in those 2 areas it seems as if PAR is still needed.

a) The NRC staff has addressed this issue in Comment 1, and will modify the DG to explicitly address Tier 2*. The staff made no additional changes to the DG in response to the comment.

b) The NRC staff disagrees with the comment as follows. DG-1321 is not intended to provide guidance for any departures from Tier 1 information including minor clerical corrections. The PAR is still needed for Tier 1 changes. However, the NRC staff is working on Alignment of Licensing Processes and Lessons Learned from New Reactor Licensing that is anticipated to be published for public comment in 2021. For information on this effort please refer to the initial and latest public meeting summaries (ADAMS Accession Nos.

ML19023A046 and ML20141L609).

The NRC staff made no changes to the DG as a result of this comment.

15 Comment Number Commenter Section of DG-1321 Specific Comments NRC Resolution 20 Michael

Tschiltz, NEI General Is the staff considering whether the current ISG-025 process should still be applicable during the period from the Notice of Intended Operations to 103(g)? Or whether the ISG-025 process should no longer be used after the Notice of Intended Operations The NRC staff addressed this issue in the response to Comment 18 and made no additional changes to the DG as a result of this comment.