ML20349A336

Public Comment Resolution Table for DG-1321

ML20349A336
Person / Time
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

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 Gary Becker Nuclear Energy Institute (NEI) NuScale Power, LLC 1201 F Street, NW, Suite 1100 6650 SW Redwood Ln #210 Washington DC 20004 Portland, OR, 97224 ADAMS Accession No. ML20189A572 ADAMS Accession No. ML20189A574 Mike Tschiltz Nuclear Energy Institute (NEI) 1201 F Street, NW, Suite 1100 Washington DC 20004 ADAMS Accession No. ML20141L506 ADAMS Accession No. ML20141L501 Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 1 Marcus General (a) The draft guidance provides a process for (a) The NRC staff agrees with the comment. The Nichol, NEI proceeding with construction for departures from guidance applies to Tier 2, which includes Tier 2*.

Tier 2 information that require an amendment but To leave no doubt, the NRC staff modified the DG to precludes changes to Tier 1 and is silent on explicitly include Tier 2* information as subject to departures from Tier 2* information. While it is the guidance. To clarify this issue, the staff added the likely that this process is also intended to be following text in Section C of DG-1321 For the applicable to Tier 2* information (Tier 2* is staffs positions articulated below Tier 2 includes defined as a subset of Tier 2 in the Part 52 Tier 2*. The staff notes that the comment is also February 2021

Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 Appendix D, for example), this should be correct in stating that the guidance does not apply to explicitly stated in the DG. Tier 1 information.

(b) The draft guidance does not take the (b) The NRC staff disagrees with the comment. As opportunity to provide a more efficient change clearly stated in the purpose and applicability of the process for Part 50 SSAR and PSAR and defaults DG, the NRC staff intended the guidance in DG-to the use of license amendments for any changes. 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 Applicable Editorial comment: DCD is the abbreviation for The NRC staff agrees with the comment and has Nichol, NEI Regulations design control document, not design certification changed the DG to refer to DCD as design control

- 10 CFR document. document.

Part 52, Appendices A, B, C, D, E,

and F (pg. 2) 2

Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 3 Marcus Related (a) NEI 96-07 Appendix C isnt yet endorsed in (a) The NRC staff agrees with the comment and has Nichol, NEI Guidance NRC guidance; however, it is approved for use by added NEI 96-07 Appendix C to the Related (pg. 3) NRC letter. Recommend including this guidance Guidance section of the DG. However, this in the list of Related Guidance. Regulatory Guide does not endorse NEI 96-07 Appendix C.

(b) RG 1.215 may also be appropriate to discuss here since this proposed approach impacts the (b) The NRC staff agrees with the comment and has timing of ITAAC correspondence and also added RG 1.215, Guidance for ITAAC Closure endorses NEI 08-01 as an acceptable method for Under 10 CFR Part 52, into the Related Guidance performing ITAAC closure. 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.

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 4 Marcus Related NEI is advocating changes to DG-1321 that would The NRC staff disagrees with the comment because Nichol, NEI Guidance obviate the need for the preliminary amendment the basis for DG-1321 does not support a mechanism (pg. 3) request (PAR) process described in COL-ISG-025. to govern departures from Tier 1. Because COL-If those changes are not implemented by the staff, ISG-025 (ADAMS Accession No. ML then COL-ISG-025 guidance should be ML15058A377) provides guidance on changes incorporated into DG-1321 to maintain flexibility during construction, which is also the subject of DG-in addressing changes during construction via the 1321, the comment understandably suggests PAR process. 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 Basis for the Since this seems to imply that the Quality The NRC staff agrees with the comment and has Nichol, NEI Changes in Assurance Program is a key part to the success of added RG 1.28, Quality Assurance Program Criteria Guidance this program, perhaps RG 1.28 should also be (Design and Construction), to the Related Guidance (pg. 6) inserted into the Related Guidance section since section of the DG as it provides guidance on both NQA-1 guidance provides some helpful Part 1 and Part 2 of the American Society of information about Conditional Release in Subpart Mechanical Engineers standard NQA-1.

2.2 in support of Basic Requirement 15. However, this would not address SSCs in the licensing basis not covered under the QA program.

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 6 Marcus Basis for The draft guidance provides very limited benefit to The NRC staff disagrees with the comment to the Nichol, NEI Changes in most Part 52 licensees due to the lack of extent the comment suggests that the NRC could use Guidance applicability to changes to Tier 1 information, this guidance to afford additional flexibility to a (pg. 7) which is the basis for the majority of the Part 52 COL holder for departures from Tier 1. DG-1321, if LARs. For Vogtle 3&4, the need for Tier 2* LARs issued as final Regulatory Guide, cannot change the was minimized by Amendment Nos. 142 and 141, treatment of Tier 1 because Tier 1 is a set of design-which provide a site-specific Tier 2* Departure specific regulations incorporated into every Evaluation Process. For design certifications Appendix to Part 52 that certifies a standard design, currently under review, the amount of Tier 2* and a COL holder must obtain an exemption in order information is expected to be minimized or to implement a proposed departure from an eliminated entirely. individual Tier 1 requirement. In that regard, Tier 1 differs from Tier 2 (including Tier 2*) because an It is stated that the basis for omitting Tier 1 from exemption is not required to depart from Tier 2.

the DG process is that it is based upon the 1999 Specifically, for Tier 2, each Part 52 design rule amending 50.59, which corresponds to the certification appendix imposes Tier 2 as a set of change process for Tier 2 information. However, requirements through text in Section II.E and III.B, by definition, Tier 1 information is derived from but allows changes in accordance with Section Tier 2. Therefore, it is logical that the guidance be VIII.B. Accordingly, an interpretive rule in guidance expanded to encompass LARs requesting can allow a COL holder to treat Tier 2 information as departures from Tier 1 information. It is it would treat FSAR information under Part 50, understood that while an expansion in scope to provided the COL holder obtains exemptions from include Tier 1 would involve justification in the §§ II.E and III.B in the applicable Part 52 design LAR, such a change would allow licensees to certification appendix and an amendment to augment obtain much of the benefit envisioned by this the change control processes in design certification guidance. appendix section VIII.

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

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 7 Marcus C. Staff Similar to the previous comment, this language For changes to Tier 1, licensees need to follow Nichol, NEI Regulatory limits the scope of the changes to a change to the NRCs exemption request procedures. To add clarity Guidance - facility or departure from Tier 2 of the plant- regarding Technical Specifications, the staff has Item 1.a (pg. specific DCD. This text precludes changes to added Technical Specifications to Items 1.a. and 1.b.

8) Technical Specifications or Tier 1 that may not in Section C of DG-1321.

impact Tier 2.

8 Marcus C. Staff The SOC for the 1999 change to the 50.59 rule did The NRC staff disagrees with this comment as Nichol, NEI Regulatory not require this 45-day precondition. It is not clear follows. For changes under 10 CFR 50.59, a licensee Guidance - why it is necessary for Part 52 COL holders. of the operating facility has the incentive to submit Item 1.a (pg. Delays to fuel load are the licensees risks. the amendment to avoid delays from restart from an

8) Also, it is not clear what happens if there is a delay outage. However, in contrast, under 10 CFR Part 52, and the submittal isn't made until day 49 or 50, for the NRC has a regulatory interest in ensuring the example. NRC staff has sufficient time to review any Perhaps it would be better to state: necessary amendments before the licensee completes The licensee should submit a request for a license the work necessary in order to submit ITAAC amendment in sufficient time to allow for NRC closure letters. The tasks necessary to review an review and approval without delaying the schedule amendment request include establishing review for making ITAAC findings or authorizing fuel schedules, allocating resources, planning inspections, load. and avoiding bottlenecks as construction nears or simply replace within 45 days with completion. That is why DG-1321 specifies the need (typically within 45 days) " for the 45 day condition. The NRC staff did not change the DG in response to this comment.

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 9 Marcus C. Staff (a) The SOC for the 1999 change to the 50.59 rule (a). Under NEPA, the NRC is required to ensure that Nichol, NEI Regulatory did not require this precondition. Why is it federal actions do not result in the irreversible or Guidance - necessary for Part 52 COL holders? The basis is irretrievable commitment of environmental resources Item 1.b (pg. not clear. Again, this text omits a change to prior to conducting an appropriate environmental

8) Technical Specifications or Tier 1 where the review. In order to fulfill NRC obligations, the staff change may not impact Tier 2. would need to evaluate any proposed change during construction prior to implementation. Thus, Item 1.b (b) Regarding the proposed changes to SSCs in the is necessary for Part 52 to ensure that the design restricted area, as defined in Part 20, this appears change qualifies for a categorical exclusion and NRC to be referring to one of the aspects of the PAR environmental review is not necessary. The NRC Process whereby the NRC verified that the change staff did not change the DG in response to this qualified for a categorical exclusion from having comment.

to perform an environmental review. If that is the case, then this point should be clearly explained in (b) The NRC staff agrees with this comment and the DG. 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 C. Staff This text does not include situations in which the The NRC staff agrees with the comment in part. The Nichol, NEI Regulatory departure affects Tech Specs or the License. (This DG has been updated to add Technical Specification Guidance - might also impact item no. 4 which addresses only to Items 1.a. and 1.b. in Section C of DG-1321. The Item 1.d (pg. Tier 1 and ITAAC. Perhaps it should also address Technical Specifications are part of the license,

8) the rest of the license, i.e., license conditions and which includes, for example, the applicable Tech Specs.) 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. .

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 11 Marcus C. Staff This text seems to imply that changes to ITAAC The NRC staff agrees with comment and provided Nichol, NEI Regulatory (Tier 1) are within the scope of this guidance. clarification to the DG. Changes to ITAAC are not Guidance - There appears to be inconsistencies in the within the scope of DG-1321. Therefore, the NRC Item 3 (pg. language used to describe the guidance scope. staff deleted and any associated exemption from

8) the certification information. from Section C, Item 3 Language from DG related to the comment: of DG-1321.

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.

12 Marcus C. Staff For a license applicant who does not reference a The NRC staff agrees with the comment and decided Nichol, NEI Regulatory certified design, is it the NRCs position that this to take Section 52.98(b) out of the Purpose in Guidance - license condition would still be required based on Section A of DG-1321. In addition the staff has Item 5 (pg. the applicability of the RG proposed here? Would narrowed the focus of the applicability of the DG-

9) a license applicant in this situation only need to 1321 to only apply to COLs issued under 10 CFR add a license condition to not submit an ITAAC Part 52 that reference a certified design, which is Closure Notification until the LAR impacting the governed by § 52.98(c).

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.

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 13 Marcus C. Staff On page 7, it states that The foregoing The NRC staff understands the comment. This text is Nichol, NEI Regulatory background and discussion applies only to the referring to exemptions to allow the process Guidance - design of a facility described in an FSAR, as described in the license condition to be used.

Item 5 (pg. updated, including Tier 2, but not Tier 1, as The referenced exemptions are not intended to allow

9) described below. the licensee to forego seeking a Preliminary Amendment Request (PAR) No Objection for Tier The exemptions to which C.5 is referring are 1 departures.

unclear. Is this text referring to exemptions to allow the process described in the license The exemptions mentioned in Section C, Item 5 of condition to be used, or is it referring to specific DG-1321 are referring to exemptions from Part 52 exemptions to allow changes to be made to sections II.E and III.B not exemptions to Tier 1.

certified information? Are the referenced exemptions intended to allow the licensee to The staff added, propose before the word forego seeking a PAR No Objection and instead exemptions in Item 5 of Section C.

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.

14 Marcus FRN Section More discussion is needed with the industry to get The NRC staff agrees with the comment in part; Nichol, NEI IV a better understanding of what is under however, these issues are beyond the intended scope consideration for inclusion in the DG regarding of the DG. The NRC staff would welcome additional timing and review of license amendments between discussions with all stakeholders in order to further the section 52.103(a) notice and 52.103(g) finding. 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.

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15 NuScale General (a) The Purpose, Applicability, and Applicable (a) The NRC staff partially agrees with comment and Regulations indicate that the guidance is decided to narrow the focus of the applicability of applicable to all COL holders, including those that DG-1321 to COLs issued under 10 CFR Part 52 that reference a Standard Design Approval (SDA) or reference a certified design, which are covered by do not reference a prior approval (i.e., a "custom 10 CFR 52.98(c). Accordingly, the staff deleted COL"). However, the Background and Staff reference to Section 52.98(b) from the purpose Regulatory Guidance focus exclusively on COLs paragraph in Section A of the DG-1321. .

that reference a certified design, including a proscription on applying the new approach to (b) The NRC staff disagrees with the comment to the departures from Tier 1 information. COLs that do extent the comment suggests that the NRC could use not reference a certified design, including those guidance to afford additional flexibility to a COL that reference an SDA, will not have Tier 1 holder for departures from Tier 1. DG-1321, if issued information. As such, the entirety of the FSAR for as final Regulatory Guide, cannot change the such a COL would be subject only to the change treatment of Tier 1 because Tier 1 is a set of design-processes of Part 50, such as 10 CFR 50.59, as specific regulations incorporated into every provided by 10 CFR 52.98(b). Thus, with the Appendix to Part 52 that certifies a standard design.

exception of changes affecting an ITAAC which A COL holder must obtain an exemption in order to are subject to an LAR a COL holder not implement a proposed departure from an individual referencing a certified design would seem capable Tier 1 requirement, as guidance cannot override a of constructing SSCs at risk for any part of the rule. See response to Comment 6 for additional design. This aspect of the guidance should be information. The NRC staff did not make any clearly stated. changes to the DG as a result of this comment.

(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 10

Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 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 As discussed in Comment 8 , the NRC has a submit the request for a license amendment regulatory interest in ensuring the NRC staff has required to authorize the change to the facility or sufficient time to review any necessary amendments departure from Tier 2 of the plant-specific DCD before the licensee completes the work necessary in within 45 days after the licensee begins order to submit ITAAC closure letters. That is why construction of the SSCs subject to the change or DG-1321 specifies the need for the 45 day condition.

departure." It is unclear why a 45 day time The staff agrees with the comment in part, but the limit is necessary, given that sufficient time to schedule for LAR submission should run from the process the LAR would depend on where in the time the licensee has approved the design package construction process the change or departure for the SSC as changed and construction of the SSC occurs, and any delay to ITAAC findings would be has begun. The NRC staff modified the text in the licensee's risk. Regardless, should a deadline Position 1.a to reflect this view in response to this remain, it should be tied to construction of the comment.

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.

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17 NuScale General Staff's position 5 states "To voluntarily adopt this The NRC staff understands the comment. As a process, a licensee should propose a license preliminary matter, the NRC staff has decided, in condition that implements the conditions in Items response to other comments, to limit the guidance to 1 and 2 above and exemptions from the applicable changes during construction under a COL that provisions of sections II.E and III.B of the Part 52 references a certified design. The response below design certification appendix referenced in the addresses a COL that references a certified design.

COL." It is unclear what license condition is necessary to implement the guidance and why. As Each Part 52 appendix that certifies a standard Staff's basis is that a change is not implemented design includes a provision in § II.E that states until ITAAC are performed, constructing the [c]ompliance with Tier 2 is required[.] (Section change prior to NRC approval does not seem to III.B of each Part 52 design certification appendix necessitate a license condition or exemption from reiterates this provision.) Because § II.E defines a design certification appendix (if a design Tier 2 as a set of requirements, it fundamentally certification is referenced). A Part 50 licensee does differs from a FSAR under Part 50. Accordingly, the not need a license condition construct changes as process for changes during construction under a COL described in the 10 CFR 50.59 SOC. Please that reference a certified design as proposed in the explain what license condition and exemptions are new guidance requires exemptions from §§ II.E and needed. 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 12

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

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 18 Michael FRN I am aware of meetings with the staff has had with The NRC staff agrees with the comment and the Tschiltz, Southern concerning a streamlined LAR process current COL-ISG-025 process should still be NEI during construction, since emergency/exigent applicable during the period from the Notice of LARs are not applicable under construction. But it Intended Operations unless and until the NRC makes is unclear exactly what the staff is considering in a finding under 10 CFR 52.103(g). The NRC staff the FRN. Is the staff considering whether the did not change the DG in response to this comment.

current ISG-025 process should still be applicable during the period from the Notice of Intended Operations to 103(g) 19 Michael General (a) DG-1321 seems to only cover a small subset of a) The NRC staff has addressed this issue in Tschiltz, what the industry was requesting in its report that Comment 1, and will modify the DG to explicitly NEI shows that there were a number of changes to Tier address Tier 2*. The staff made no additional 1 and Tier 2* that created challenges. Not sure changes to the DG in response to the comment.

why Tier 2* isnt addressed in the DG.

(b) Also it is not clear why minor clerical b) The NRC staff disagrees with the comment as corrections to Tier 1 information is excluded from follows. DG-1321 is not intended to provide the process. Without the additional relief in those 2 guidance for any departures from Tier 1 information areas it seems as if PAR is still needed. 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.

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Comment Commenter Section of Specific Comments NRC Resolution Number DG-1321 20 Michael General Is the staff considering whether the current ISG- The NRC staff addressed this issue in the response to Tschiltz, 025 process should still be applicable during the Comment 18 and made no additional changes to the NEI period from the Notice of Intended Operations to DG as a result of this comment.

103(g)? Or whether the ISG-025 process should no longer be used after the Notice of Intended Operations 15