ML21029A125

IMC 0335 Comment Resolution - Public Industry Comments

ML21029A125
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Issue date:	12/01/2020
From:	Derek Scully NRC/NRR/DSS/SCPB
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Scully D
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ML20325A116	List: ML20325A150 ML20325A180 ML21029A125
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DC 20-041
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Comment Resolution Summary (ML21029A125)

Resolution of Public Comments for:

IMC 0335 Changes, Tests, and Experiments ML20325A180)

Public Meeting Date: December 1, 2020 Comment # Source Section # Comment Added Remarks 55 NEI 04.03 In the definition of MOE, the elements from NEI 96-07 rev. 1 are N Section 06.19 of the IMC included however additional information that is also referenced discusses this concept in greater would be useful to the inspector. detail than the definitions section.

No change required.

Changes to such methods of evaluation require evaluation under 10 CFR 50.59(c)(2)(viii) only for evaluations used either in UFSAR safety analyses or in establishing the design bases, and only if the methods are described, outlined or summarized in the UFSAR. Methodology changes that are subject to 10 CFR 50.59 include changes to elements of existing methods described in the UFSAR and to changes that involve replacement of existing methods of evaluation with alternative methodologies.

Recommendation: Consider adding the additional information from NEI 96-07, 3.10 to the MOE definition.

56 NEI 04.06, The title should include the term general licensees in addition N The definition in IMC 0335 page 3, to ISFSI or MRS facility to describe all of the licensee types. matches the definition in NEI 12-Def 04. No change required.

Recommendation: Add general licensees to the title.

Date: December 1, 2020 1 0335

57 NEI 04.07, Final Safety Analysis Report (as updated) definition should Y Revised the definition in IMC page 3, include the UFSAR for CoC holders and for general licensees. section 04.07 to include a Definitions Example: Updated Final Safety Analysis Report (UFSAR) (10 definition for the general CFR 72.48) - FSAR (as updated) means: licensees and CoC holders.

• for specific licensees, the Safety Analysis Report for a facility submitted and updated in accordance with 10 CFR 72.70

• for general licensees, the Safety Analysis Report for a spent fuel storage cask design, as amended and supplemented

• for CoC holders, the Safety Analysis Report for a spent fuel storage cask design submitted and updated in accordance with 10 CFR 72.248.

The FSAR for both specific licensees and CoC holders is the first version of the safety analysis report issued just after the initial approval of the ISFSI license or DSS design. The UFSAR for specific licensees and CoC holders is always the latest revision updated thereafter, pursuant to §72.70 or §72.248, as supplemented by changes authorized under the provisions of 10 CFR 72.48.

The above definition of UFSAR for general licensees requires additional clarification. For general licensees, the UFSAR is owned and maintained by the CoC holder for the cask design(s) used at the ISFSI. The UFSAR for the general licensee is the UFSAR revision used to load the particular serial number cask(s) and place them into storage at the ISFSI, as revised by any applicable 10 CFR 72.48 changes made by the CoC holder and the general licensee. Once the casks loaded under a particular cask UFSAR are placed into service at a generally licensed ISFSI, the UFSAR revision and 10 CFR 72.48 changes applicable to a given serial number cask remain constant unless the CoC holder requires a change to be applied to a previously loaded cask. A general licensee also has the option to choose to apply a later CoC amendment and associated UFSAR revision to previously loaded casks pursuant to 10 CFR 72.212(b)(4). Because of this unique situation for general licensees, different casks in service at the same ISFSI under the same CoC may have different licensing bases.

Recommendation: Consider adding in 10 CFR 72.48 elements to this definition or having a separate definition for this aspect.

Date: December 1, 2020 2 0335

Comment # Source Section # Comment Added Remarks 58 NEI Definitions Since NEI 97-04, rev. 1 Appendix B, Guidance and Examples Y NEI 97-04, Appendix B, Rev 1 04.13, for Identifying 10 CFR 50.2 Design Bases is endorsed by RG and RG 1.186 have been added 04.14, 1.186, Guidelines and Examples for Identifying 10 CFR 50.2 to the references in Section 0335-04.15. Design Bases, there may be value having it referenced for 09.

NRC inspectors.

NEI 97-04 rev. 1 Appendix B endorsed by RG 1.186 contains useful information on these design bases/function definitions.

Recommendation: Consider adding a note that references NEI 97-04, Rev, 1, Appendix B, Guidance and Examples for Identifying 10 CFR 50.2 Design Bases (endorsed by RG 1.186) for more information on these definitions.

59 NEI Def 06.05 describes the relationship between 50.59 & 50.155. It N This comment is outside the may be beneficial to include; beyond the design basis events scope of this IMCs purpose. No to the definition section. This could help inspectors especially definition of beyond design basis when these are described in the UFSAR. events is needed in the IMC, which is not creating new Recommendation: Consider adding a definition for beyond the interpretations or definitions. No design basis events and that they are not subject to 50.59 change.

60 NEI Definitions Malfunction of SSCs important to safety is missing that non- Y NRC agrees, definition changed:

safety related (NSR) SSC need to be considered as part of this definition. The failure of SSCs to perform their intended design functions Recommendation: Add NSR to the definition as described in described in the UFSAR. For NEI 96-07 rev.1. reactor licensees, this means whether or not the SSC is classified as safety-related.

61 NEI 0335-06, There is no information that describes the relationship between Y Section addressing SFCP page 5 50.59 and Surveillance Frequency Control Program (SFCP). relationship to 10 CFR 50.59 has Adding details including implementation lessons learned similar been added.

to the relationship between 10 CFR 50.59 and Fire Protection could be beneficial.

Recommendation: Add a section describing the relationship between 50.59 and the Surveillance Frequency Control Program (SFCP).

Date: December 1, 2020 3 0335

Comment # Source Section # Comment Added Remarks 62 NEI 06.02, Consider adding clarification when 50.59 is used as part of a TS N The TS Admin Controls section page 6 bases change that it cannot directly conflict with the as-stated contains the TS Bases Control requirements of the TS. Program and provides this guidance. No change.

This will help inspectors distinguish between how 50.59 is used to support TS bases changes.

Recommendation: Add the following statement to the end of this section; A TS bases change cannot be made pursuant to 10 CFR 50.59 that directly conflict with the as-stated requirements of the TS.

63 NEI 06.03, This section references RG 1.186, Guidelines and Examples N See response/action to Comment page 6 for Identifying 10 CFR 50.2 Design Bases but not NEI 97-04 #58 above rev.1, Appendix B, Guidance and Examples for Identifying 10 CFR 50.2 Design Bases NEI 97-04 rev. 1 Appendix B endorsed by RG 1.186 contains useful information on these design bases/function definitions.

Recommendation: Add NEI 97-04 rev. 1, Appendix B as a reference to this section since it is endorsed by RG 1.186.

Date: December 1, 2020 4 0335

Comment # Source Section # Comment Added Remarks 64 NEI 06.05, Additional clarification may be useful to the inspectors regarding N This IMC will not provide new or page 7 this relationship. revised interpretations on the scope of 10 CFR 50.59.

10 CFR 50.59 is not applicable to SSCs that have only beyond-design-basis-functions, do not interact with SSCs with design basis functions (i.e., there are physical separations and separation of power, instrumentations and controls), and credibility of adverse impact arising from modification of these beyond-design-basis SSCs to the important to safety SSCs are precluded.

Recommendation: Consider adding the following statement at the end of the paragraph; 10 CFR 50.59 is not applicable to SSCs that have only beyond-design-basis-functions, do not interact with SSCs with design basis functions (i.e., there are physical separations and separation of power, instrumentations and controls), and credibility of adverse impact arising from modification of these beyond-design-basis SSCs to the important to safety SSCs are precluded.

65 NEI 06.06, This section is listed after 06.01 - 06.05 that describes N Sections 06.01 through 06.05 page 8, regulations that contain control processes and the applicability discuss the relationships between App Det determination process. It may benefit inspectors to have this as various regulations and 10 CFR the header to sections 06.01-06.05 since those described 50.59 and are meant to provide applicability determinations. background insights to inspectors prior to the background on the Recommendation: Consider making 06.06 and overarching 50.59 process. Sections 06.01 section that contains the information described in 06.01-06.05 through 06.05 inform the in addition to the content in 06.06. applicability review in section 06.06 and all sections following.

No change.

66 NEI 06.06, In this sections and other sections throughout. The terms CTE N 10 CFR 50.59 uses change, test, page 8, is used when activity may be better in describing the proposed or experiment and not activity App Det CTE. for what is covered by the rule.

No change.

Recommendation: Consider in this section (any other sections) the use of proposed activity versus proposed CTE Date: December 1, 2020 5 0335

Comment # Source Section # Comment Added Remarks 67 NEI 06.08 3rd paragraph states that; If a change has no effect or has only Y The text has been changed in the page 9 beneficial effects, it does not trigger any of the evaluation following manner:

criteria concerning more than minimal increase in frequency or occurrence of malfunction or higher consequences, etc If a change has no effect or has only beneficial effects, it does not May be better worded as; If a change has no effect or has only trigger satisfy any of the beneficial effects, it is not more than a minimal increase in evaluation criteria concerning frequency or occurrence of malfunction. more than minimal increase in frequency or occurrence of This may improve clarity for the inspectors. malfunction or higher consequences, etc. If the Recommendation: Consider changing underlined text to is not licensee cannot conclude that more than a minimal increase in frequency or there is no adverse effect, a occurrence of malfunction 10 CFR 50.59 evaluation is required.

68 NEI 06.09, Last paragraph in 06.09 states; However, testing that removes Y Language in IMC will remain; page 11 an SSC from service for maintenance, if it is not a prolonged Pointer to appropriate sub-section removal, does not require a 10 CFR 50.59 evaluation because in 0335-06added.

it is controlled by 10 CFR 50.65(a)(4).

The point of this section is to ensure that inspectors understand that removing equipment from service is controlled under 10CFR50.65(a)(4). Reinforcing the point about prolonged removal doesnt seem to fit the intent of this section and is not a defined term. Considering referring to section 6.20 when assessing maintenance activities.

Recommendation: Remove if it is not a prolonged removal from statement.

Date: December 1, 2020 6 0335

Comment # Source Section # Comment Added Remarks 69 NEI 06.10, In the 1st paragraph, inspectors may benefit from language Y 10 CFR 50.59 requires that each page 11 included under 72.48 section (page 37) to make it clear how the element of a CTE be separately 50.59 criteria are assessed. evaluated against each of the 10 CFR 50.59(c)(2) criteria. The If the 10 CFR 50.59 screening for the proposed activity documented evaluation should concludes that a change to an MOE is not involved, then the 10 justify the applicability of each CFR 50.59 evaluation should reflect that 10 CFR criterion. The proposed language 50.59(c)(2)(viii) is not applicable. If the 10 CFR 50.59 screening reads that you do not need to determines that the proposed activity involves only a change to evaluate all criteria if one is met.

an MOE, then the 10 CFR 50.59 evaluation should reflect that criteria 10 CFR 50.59(c)(2)(i) through (vii) are not applicable. No change to Section 06.10.

Recommendation: Add this information to the first paragraph; This language in Section 07.20 has been deleted.

If the 10 CFR 50.59 screening for the proposed activity concludes that a change to an MOE is not involved, then the 10 CFR 50.59 evaluation should reflect that 10 CFR 50.59(c)(2)(viii) is not applicable. If the 10 CFR 50.59 screening determines that the proposed activity involves only a change to an MOE, then the 10 CFR 50.59 evaluation should reflect that criteria 10 CFR 50.59(c)(2)(i) through (vii) are not applicable.

70 NEI 06.10, 2nd to last paragraph states; Each element of a CTE should be N See response to Comment #66 page 11 separately evaluated against each of the 10 CFR 50.59(c)(2) above.

criteria unless the elements of a CTE are interdependent.

The inspectors may benefit from the use of proposed activity versus CTE.

Recommendation: Consider changing CTE to proposed activity in this paragraph.

Date: December 1, 2020 7 0335

Comment # Source Section # Comment Added Remarks 71 NEI 06.11, This section may benefit from the reinforcement that alteration N Section 6.11 (now 6.13) of the page 12 of the design basis limit for a fission product barrier (DBLFPB) IMC addresses the minimal requires prior NRC approval via a license amendment. increase principle, which affects the four minimal increase Recommendation: Consider reinforcing the information criteria in 10 CFR 50.59.

contained on page 19 in this section that any change to the Discussion of design basis limit DBLFB is adverse for a fission product barrier is outside the scope of this section.

No change made.

Date: December 1, 2020 8 0335

72 NEI 06.12 The following wording changes will help inspectors understand Y For recommended change 1, page 13 how the SOCs apply without limiting the use of PRA or other revised to use the language in the risk insights that would be appropriate in supporting 50.59 SOCs.

evaluations. The current wording appears to extend beyond the intent of the SOCs and would add additional restrictions on the For recommended change 2, use of PRA methods. Wording changed to:

1. Consistent with the Commissions statements supporting However, while the resultant CDF the final 10 CFR 50.59 rule, inspectors should verify that and LERF from the PRA are not licensees did not use RG 1.174 or its values for change in acceptable to inform not CDF and/or LERF as the basis for 10 CFR 50.59 acceptable as the sole basis to evaluations. inform the licensees 10 CFR 50.59 evaluation, it is While we understand the intent of this statement, its values acceptable for licensees to use could be misinterpreted as meaning that the same values as reasonable engineering practices, described in RG 1.174 derived from another source would not engineering judgement, and PRA be allowable. techniques, as appropriate, to inform 10 CFR 50.59 evaluations Recommend clarifying by stating; inspectors should verify that with respect to more than a licensees did not use RG 1.174 to determine values for minimal increase.

changes in CDF and/or LERF used during 10 CFR 50.59 evaluations.

2. However, while the resultant CDF and LERF from the PRA are not acceptable to inform the licensees 10 CFR 50.59 evaluation Again, inspectors could infer that the use of PRA is not acceptable versus the use of CDF and LEFF from RG 1.174 or how CDF and LERF could be used.

Recommend clarifying by using similar wording from the Oct NRC public meeting; However, while the resultant CDF and LERF from the PRA are not acceptable as the sole basis to inform the licensees 10 CFR 50.59 evaluation Recommendation: The following changes would better align with the intent of the SOC and not cause confusing on how PRA may be used in support a 50.59 evaluation.

Date: December 1, 2020 9 0335

Comment # Source Section # Comment Added Remarks

1. Change RG 1.174 or its values to; RG 1.174 to determine values

2. Change are not acceptable to inform to; are not acceptable as the sole basis to inform 73 NEI 06.13, It would be beneficial to inspectors to include more detail on N Each licensees CLB contains page 14, how the GDC relates to the CLB in these sections and what to detailed descriptions of how the (criterion i) expect by the licensee during the 50.59 evaluation. facility complies with the GDC.

06.14, The licensees 10 CFR 50.59 page 15, Recommendation: Add clarification to these sections that evaluation documents the impact (criterion ii) describes the relationship between the GDC and CLB and that of the CTE on the facilitys CLB.

a licensees evaluation should demonstrate how the minimum This recommendation is outside performance standards continue to be met as part of the the scope of the IMC, which is not evaluation of this criterion. adding new interpretations. No change.

74 NEI 06.15, Consider adding the following statement to this section to aid N Mission dose is not a concept page 15, inspectors with additional guidance contained in NEI 96-07 rev. discussed in the SOCs. No (criterion iii 1 Sect 4.3.3 defining what is considered more than a minimal change.

& iv) increase.

NEI 96-07 sect. 4.3.3. For changes affecting the dose to operators performing required actions outside the control room, an increase is considered more than minimal if the resultant mission dose exceeds applicable GDC 19 criteria.

Recommendation: Add the following to section; For changes affecting the dose to operators performing required actions outside the control room, an increase is considered more than minimal if the resultant mission dose exceeds applicable GDC 19 criteria.

Date: December 1, 2020 10 0335

Comment # Source Section # Comment Added Remarks 75 NEI 06.15, The following statement in the 2nd paragraph appears to be The IMC text quoted in this page 16, misplaced. comment is directly from the (criterion iii SOCs at 53593, specifically from

& iv) Changes in methodology used to calculate radiological the section providing examples consequences would fail criterion (viii) of 10 CFR 50.59 and for minimal increases. This IMC is require prior NRC review regardless of how small the increase not providing a new interpretation is in the calculated radiological consequences. of 10 CFR 50.59.

If the intent is to keep this statement, it should be modified to state; Changes in methodology used to calculate radiological consequences would be evaluated under criterion (viii) of 10 CFR 50.59 and require prior NRC review regardless of how small the increase is in the calculated radiological consequences.

This terminology would better align with guidance.

Recommendation: Delete the following statement; Changes in methodology used to calculate radiological consequences would fail criterion (viii) of 10 CFR 50.59 and require prior NRC review regardless of how small the increase is in the calculated radiological consequences. If intent is to keep it, consider the following for clarification; Changes in methodology used to calculate radiological consequences would fail be evaluated under criterion (viii) of 10 CFR 50.59 and require prior NRC review regardless of how small the increase is in the calculated radiological consequences.

Date: December 1, 2020 11 0335

Comment # Source Section # Comment Added Remarks 76 NEI 06.17, The following information from NEI 96-07 rev. 1 Section 4.3.6 N Section provides sufficient page 18, will aid inspectors with understanding aspects that describe this guidance to inspectors on (Criterion criterion. criterion (vi) as is. No change.

vi)

Malfunctions of SSCs are generally postulated as potential single failures to evaluate plant performance with the focus being on the result of the malfunction rather than the cause or type of malfunction. A malfunction that involves an initiator or failure whose effects are not bounded by those explicitly described in the UFSAR is a malfunction with a different result.

A new failure mechanism is not a malfunction with a different result if the result or effect is the same as, or is bounded by, that previously evaluated in the UFSAR.

Recommendation: Add the following to the beginning of 06.17 Malfunctions of SSCs are generally postulated as potential single failures to evaluate plant performance with the focus being on the result of the malfunction rather than the cause or type of malfunction. A malfunction that involves an initiator or failure whose effects are not bounded by those explicitly described in the UFSAR is a malfunction with a different result.

A new failure mechanism is not a malfunction with a different result if the result or effect is the same as, or is bounded by, that previously evaluated in the UFSAR.

77 NEI 06.20, Adding a statement such as; timeliness of corrective actions is N The NRC does not define or page 23 evaluated under 10 CFR Appendix B, Criterion XVI. discuss timeliness in the manner suggested in this This would align with the PI&R inspection guidance and what comment and is not creating new governs how timeliness of corrective actions should be interpretations of requirements in assessed. this IMC. No change.

In some cases, inspectors reference 50.59 when assessing timeliness of corrective actions.

Recommendation: Consider adding a statement; Timeliness of corrective actions is evaluated under 10 CFR Appendix B, Criterion XVI.

Date: December 1, 2020 12 0335

Comment # Source Section # Comment Added Remarks 78 NEI 06.20, 2nd paragraph, the use of proposed activity may be more N See response to Comment #66 page 23 appropriate than CTE (similar to overall note) above.

The use of CTE doesnt seem to fit this section as well.

Recommendation: Consider changing CTE to proposed activity.

Date: December 1, 2020 13 0335

Comment # Source Section # Comment Added Remarks 79 NEI 06.20, The following descriptions from Part 9900 for 50.59 could aid Y Certain elements of the 50.59 page 23, the inspectors on considerations for determining when technical guidance have been 24 equipment removed from service for maintenance could incorporated in the IMC, including become a change that would need to be assessed under 50.59. Section 06.20.

Removing equipment from service (making it inoperable) for maintenance during the technical specification (TS) allowed outage time does not require application of 10 CFR 50.59.

Removing non-TS equipment from service is covered by the requirements of the maintenance rule (10 CFR 50.65). 10 CFR 50.59 does not need to be applied. One way to decide if a particular activity is "maintenance" or a "change" is to determine if the plant will be returned to its as-design condition following the activity The reliance upon the Paragraph 50.65(a)(4) assessment in lieu of a section 50.59 evaluation also extends to temporary alterations (or test activities) directly related to and required in support of specific maintenance activities. This guidance also applies to temporary alterations in support of implementation of a modification (the modification itself is subject to the Section 50.59 review process with respect to operation following installation). However, if the temporary alterations (including those affecting operator actions and procedures as described in the FSAR (as updated)) are not in support of maintenance, or are expected to remain in place for more than 90 days at power, a Section 50.59 review is to be performed in addition to the Paragraph 50.65(a)(4) assessment. Refer to the regulatory guidance (for Section 50.59 and for Paragraph 50.65(a)(4)) for further information.

Recommendation: Consider adding additional elements from (or referencing) Part 9900, 50.59.

Date: December 1, 2020 14 0335

Comment # Source Section # Comment Added Remarks 80 NEI 0335-07, First bullet discusses NEI 12-04 but doesnt mention RG 3.72. Y Added reference to RG 3.72 and page 25,

• Applicability and Screening: Licensees and CoC holders may NEI 12-04 in Section 9 of the first bullet follow these processes, as described in NEI 12-04, to determine IMC.

if another process governs the CTE or if the licensee or CoC holder may need to perform a 10 CFR 72.48 evaluation.

RG 3.72 contains clarifications and exceptions to NEI 12-04.

Recommendation: Add reference to RG 3.72 in this section that endorses NEI 12-04. (e.g., RG 3.72 rev. 1 endorses NEI 12-04, rev. 2)

Date: December 1, 2020 15 0335

81 NEI 0335-07, Section may benefit from the following re-wording. It also has a Y Maintained the original language page 25 better tie to general licensees. and added the suggested wording.

Each 10 CFR 72 General Licensee stores spent nuclear fuel in Spent Fuel Storage Canisters/Casks in an Independent Spent Fuel Storage Installation (ISFSI) licensed to a particular amendment of a particular Certificate of Compliance (CoC).

Each CoC Amendment has, appended to it, unique Technical Specifications. The CoC itself will reference the applicable UFSAR revision. The approval of a particular CoC Amendment is documented in a unique NRC Safety Evaluation Report (SER). A report, generated by the General Licensee pursuant to 10 CFR 72.212, documents the conformance of the loaded canisters/casks and the ISFSI to the requirements detailed in the applicable licensing basis. Differences between the design and operation of the loaded canisters/ISFSI and the design and operation of the canisters/ISFSI described in the UFSAR are identified within the 72.212 report and reviewed under 10 CFR 72.48. The loaded canisters/casks and ISFSI remain licensed under the same CoC Amendment, Technical Specifications (TSs), UFSAR Revision, and SERs until the loaded fuel is removed from the ISFSI (or the canisters are recertified to another CoC Amendment). Should a General Licensee later opt to store spent nuclear fuel in a canister/cask licensed under a different CoC/CoC Amendment, this different CoC/CoC Amendment will have associated with it, its own TS, UFSAR Revision, and SERs. This subsequently loaded fuel will have an associated 72.212 Report and supporting 72.48 reviews. Thus, it is feasible for a single General Licensee to have, in effect, a single ISFSI with canisters/casks loaded and stored to two or more CoC Amendments, each having separate corresponding TSs, UFSARs, and NRC SERs. For such installations, the licensee should ensure that activities are reviewed under 72.48 in light of which CoC amendment(s) etc., is(are) applicable to the activity.

Note - If decision to keep the original language, the next 3 comments address how to improve them as written.

Date: December 1, 2020 16 0335

Comment # Source Section # Comment Added Remarks 2nd para. Revise the 2nd sentence to say Licensees and CoC holders processes In the first bullet it should be recognized that the applicability determination also decides whether no regulatory review is required at all (i.e., for editorial or administrative changes).

2nd bullet: Prior to (2) add a CoC amendment is required under.

Recommendation: Suggested wording improvements for this overview. Or specific changes to consider if the original wording is maintained. Revise to reflect no regulatory review needed for editorial or administrative changes.

82 NEI 07.01, Title references 72.78 versus 72.48 Y Title has been changed from page 25 Typo. 72.78 to 72.48 Recommendation: Change 72.78 to 72.48.

83 NEI 07.01, 1st para.: The reference to using 0335-06 for 72.48 should be N NEI 12-04 is a method endorsed page 25 clarified by adding consistent with the endorsed guidance in by the NRC to demonstrate NEI 12-04. compliance with 72.48. The IMC Section 07.01 specifies the There are some elements of the 50.59 rule and guidance that relationships between 72.48 and do not apply to 72.48. 50.59 as detailed in the 1999 SOCs. No change.

Recommendation: Add phrase as suggested Date: December 1, 2020 17 0335

Comment # Source Section # Comment Added Remarks 84 NEI 07.01, The 2nd paragraph, 2nd sentence should also be included in Y Agree. IMC has been revised to page 25 0335-06, with appropriate re-wording for the 50.59 program add the following to 0335-06:

because changes made to SSCs under 50.59 can also affect the ISFSI and require 72.48 review. RELATIONSHIP BETWEEN 10 CFR 50.59 AND 10 CFR 72.48 Recommendation: Add sentence in 07.01 to the language in 0335-06 to reflect interplay between 50.59 and 72.48. As a part of rulemaking in 1999, the staff revised the regulations in 10 CFR 72.48 to conform with the revised 10 CFR 50.59 rule in order to provide consistent implementation of these two regulations.

Other sections of this IMC discuss key definitions, provide guidance for reviewing the licensees and CoC holders processes for applicability and screening, and performing an assessment of 10 CFR 72.48 evaluations. Inspectors should be aware that changes in the ISFSI and spent fuel storage cask design may affect the Part 50 license if co-located and may require analyses in 10 CFR 50.59 and 10 CFR 72.48.

Date: December 1, 2020 18 0335

Comment # Source Section # Comment Added Remarks 85 NEI 07.02, 1st para: Y Licensees and CoC Holders may page 25 a) It is not clear why Part 71, Subpart H is included here. use a previously approved Seems like Part 72, Subpart G is all that should be referenced. program under Part 71, Subpart Suggest deleting this discussion to avoid confusion and H or Appendix B to Part 50 to inappropriate mixing of Part 71 and 72 requirements. satisfy the requirements of an b) Change or implementation of 10 CFR 72.212 evaluation to established program under Part or implementation of a Part 72 general license. 72. There was no change as suggested from recommendation Recommendation: a) Suggest deleting Subpart H. (a). Revised wording to the (b) Revise wording as suggested suggested language as described in recommendation (b).

86 NEI 07.03, The purpose of this section is not clear. It provides discussion N The purpose of this section was page 26 of dual-purpose systems but then concludes Part 71 is outside to provide the inspector the scope of the IMC. Suggest deleting this section to avoid information above dual-purpose confusion and inappropriate mixing of Part 71 and 72 systems and how changes made requirements. to Part 72 may impact Part 71 requirements. There was no Is the intent to reinforce this aspect? Inspectors should be change to this section as aware of changes to activities that affect Part 71 design and recommended.

licensing bases and will need to be assessed and controlled under Part 71 requirements.

Recommendation: Consider removing this section or add additional information on what it is included for the inspector.

87 NEI 07.05, 1st para.: Suggest deleting the last sentence. This may be Y Revised the IMC to delete the last page 27 colloquially true, but there are too many differences between a sentence in the first paragraph.

212 report and a specific ISFSI license UFSAR to make this statement.

Recommendation: Suggest deleting section as unnecessary and to avoid confusion.

Date: December 1, 2020 19 0335

Comment # Source Section # Comment Added Remarks 88 NEI 07.05, 2nd para.: Y This IMC is intended to assist the page 27 a) Add clarification as to whether parts of the 212 report not staff when reviewing changes in governed by 72.212(b)(5) and (b)(6) are or are not governed by the facility or spent fuel storage 72.48. The 212(b)(7) regulation seems to be narrowly written to cask design as described in the apply to just these sections of the 212 report. final safety analysis report as b) Suggest adding a reference to RIS 2012-05. updated. This document does c) Implementation of 212(b)(7) has been the source of recent not provide any new enforcement action for general licensees. Suggest adding more interpretations or rules pertaining clarity as to how the NRC interprets a deviation from the cask to 10 CFR 50.59 or 10 CFR UFSAR with respect to evaluations in the 212 report. Consult 72.48. This includes no new RIS 2012-05 in this regard. interpretations of other regulations identified in this Recommendation: (a) Clarify as suggested. document such as 10 CFR (b) Add reference as suggested. 72.212. The staff reviews (c) Add clarification on how NRC interprets a deviation from a regulations, generic cask UFSAR with respect to evaluations in the 212 report. communications and other documents as applicable for related staff positions to obtain additional information (e.g.

Regulatory Guides and Regulatory Information Summaries).

The recommendation to add the suggested reference of RIS 2012-05 is included in Section 9 of this IMC.

89 NEI 07.05, 3rd para.: The point being made in the penultimate sentence is Y Revised the IMC to include the page 27 not clear and the sentence seems to be misplaced. General recommendation to delete licensee site-specific deviations from the cask FSAR authorized sentence as suggested and under 72.48 are not included in a modification to the generic revise paragraph since the cask FSAR. Each general licensee tracks these independently. previous paragraph adequately Suggest deleting this sentence. The relationship between the addressed the concepts.

cask UFSAR, the 212 report, and 72.48 is adequately addressed in the previous paragraph.

Recommendation: Delete sentence as suggested.

Date: December 1, 2020 20 0335

Comment # Source Section # Comment Added Remarks 90 NEI 07.06, For general licensees, other regulations (e.g., 10 CFR 50.54) N As stated in Section 07.06, the page 27 also applies for some programs. While only some examples of examples provided are not meant these regulations that contain a change control process in Part to be exhaustive. No change.

72 regulations are listed in this section, NEI 12-04 list is more comprehensive.

Recommendation: Suggest either adding the additional regulations or referencing back to NEI 12-04 Sect. 4.1.

91 NEI 07.08, 5th paragraph states that Inspectors should recognize that Y Revised the IMC to include the page 28 changes reducing an SSCs capability, performance, recommendation to add the qualification, or reliability are adverse. suggested language.

May be better worded as; Inspectors should recognize that changes reducing an SSCs capability, performance, qualification, or reliability in the accomplishment of its as-credited design function is adverse.

This will help improve clarify for the inspector to distinguish between credited design functions from those that do not.

Recommendation: Add; in the accomplishment of its as-credited design function to distinguish between changes that do not affect a credited design function from ones that do.

92 NEI 07.08, Last para.: The term unintended change is not in the N The paragraph discussed in page 29 regulations, RG 3.72 or NEI 12-04. this comment is from the Inspection Manual Part 9900 It would not be clear to inspectors what this is intending. 10 CFR Guidance on 10 CFR 50.59. This IMC is not Recommendation: Suggest explaining the term using existing definitions, providing a new definition in the appropriate providing new guidance document, or otherwise more fully explaining the issue and the interpreting 10 CFR 50.59.

process to be followed Date: December 1, 2020 21 0335

Comment # Source Section # Comment Added Remarks 93 NEI 07.10, In the 1st paragraph, inspectors may benefit from language Y 10 CFR 72.48 requires that each page 29 included later under 72.48 section 07.20 (page 37) to make it element of a CTE be separately clear how the 72.48 criteria are assessed. evaluated against each of the 10 CFR 72.48 criteria. The If the 10 CFR 72.48 screening for the proposed activity evaluation should justify the concludes that a change to an MOE is not involved, then the 10 applicability of each criterion.

CFR 72.48 evaluation should reflect that 10 CFR The proposed language appears 72.48(c)(2)(viii) is not applicable. If the 10 CFR 72.48 screening to read that you do not need to determines that the proposed activity involves only a change to evaluate all criteria if one is met.

an MOE, then the 10 CFR 72.48 evaluation should reflect that No change.

criteria 10 CFR 72.48(c)(2)(i) through (vii) are not applicable.

This language has been removed Recommendation: Add this information to the first paragraph; from Section 07.20.

If the 10 CFR 72.48 screening for the proposed activity concludes that a change to an MOE is not involved, then the 10 CFR 72.48 evaluation should reflect that 10 CFR 72.48(c)(2)(viii) is not applicable. If the 10 CFR 72.48 screening determines that the proposed activity involves only a change to an MOE, then the 10 CFR 72.48 evaluation should reflect that criteria 10 CFR 72.48(c)(2)(i) through (vii) are not applicable.

94 NEI 07.10, 1st para.: Delete or CoC holder from the last sentence. Y Revised the IMC to include the page 29 recommendation to delete the CoC holders do not request license amendments per 72.56. suggested language.

Recommendation: Delete phrase as suggested 95 NEI 07.10, 3rd para.: At the beginning of the 2nd sentence, add While the N The paragraph as written page 29 SER does not impose requirements on the licensee or CoC provides sufficient guidance to holder, inspectors inspectors. No Change.

Improves guidance.

Recommendation: Add phrase as suggested.

Date: December 1, 2020 22 0335

Comment # Source Section # Comment Added Remarks 96 NEI 07.10, 4th para.: The 2nd bullet does not clearly describe the two Y Revised the IMC to include the page 30 separate types of MOE changes as described in the definition recommendation to add the of a departure from an MOE in the regulations. Suggest revising suggested language.

to refer to 1) A change to an element of a method described in the UFSAR or 2) a different method from that described in the UFSAR.

This will provide better guidance in this area.

Recommendation: Revise as described.

97 NEI 07.11, Most ISFSIs and cask designs were not licensed per NUREG- Y Revised the IMC to include the page 30 2215. Suggest replacing this reference with a reference to the recommendation to add the applicable SRP for the ISFSI license or cask design CoC. suggested language.

Improves inspector guidance.

Recommendation: Replace reference as suggested.

98 NEI 07.12 The blanket reference to Section 06.12 is not applicable for N Agree. Section has been page 30 72.48. PRA does not apply to Part 72 and the NRC asked that changed to address licensees we remove references to PRA from NEI 12-04. Suggest adding who are committed to RG 3.72, Part 72-specific guidance to inspectors for licensee use of Revision 0, versus Revision 1.

probabilistic analysis techniques, including any limitations.

May cause confusion to inspectors as written.

Recommendation: Suggest adding Part 72-specific guidance on use of PRA.

99 NEI 0335-07.13 Reg Guide 3.72, Revision 1 has exceptions and clarifications Y Reference added to RG 3.72, thru 20 that apply to the 72.48 criteria that should be recognized in the Rev 0 and 1. Additionally, the appropriate sections to help the inspectors during the inspection staff has integrated the applicable activity. exceptions and clarifications within the IMC as necessary.

This will aid inspectors during inspection activities Recommendation: Consider a broad review of these sections to include applicable exceptions and clarifications form RG 3.72, Rev.1.

Date: December 1, 2020 23 0335

Comment # Source Section # Comment Added Remarks 100 NEI 0335-09, The following guidance documents are not listed in the Y Reference list fully updated.

page 40 references.

• 10 CFR 72.48, Changes, Tests, and Experiments.

• Regulatory Guide 3.72, Guidance for Implementation of 10 CFR 72.48, Changes, tests, and experiments.

• NEI 97-04. rev. 1 Appendix B, Guidance and Examples for Identifying 10 CFR 50.2 Design Bases

• NUREG-1536 &1537 (precursors to NUREG-2215 that were the governing SRPs for most ISFSAs and cask designs)

• RIS 2012-05, Clarifying the Relationship Between 10 CFR 72.212 and 10 CFR 72.48 Evaluations Recommendation: Consider adding additional references as described.

101 NEI General Use of NEI 96-07 should reference revision 1 to ensure clarity Y Agree. IMC was changed to Comment of endorsed guidance. reference revisions.

OR If revisions were not intended to be use, statements that reflect that the latest endorsed guidance should be used.

Minimize the potential for inspectors to reference outdated information Recommendation: Add revision 1 when NEI 96-07 is referenced.

OR Include a statement that the inspectors should reference the latest endorsed references for their use.

Date: December 1, 2020 24 0335

Comment # Source Section # Comment Added Remarks 102 NEI General Since this inspection manual is to inspect all activities related to Y Section added related to digital Comment 50.59, including information from NEI 96-07 Appendix D and I&C activities.

associated rev. 2 of RG 1.187 would benefit inspectors inspecting areas associated with digital I&C.

Recommendation: Add information and references to reflect digital I&C 50.59 related activities.

103 NEI General In Section 6.13 and 6.14, the examples in NEI 96-07 rev.1 are N This concept will be addressed in Comment not included. This is ok but it would be good to make a inspector training. Additional statement in the IMC similar to RG 1.187 that the examples in information on this point can be NEI 96-07 are meant to illustrate and reinforce the concepts found in RG 1.187, Rev. 2.

contained in the body of the document. Examples may not apply in all cases and other approaches not described by an example are allowed. In either case, inspectors should ensure the approach taken is applicable to its particular circumstance as described in the content of NEI 96-07 rev.1.

Recommendation: Add info to ensure the inspectors understand how to consider examples referenced in 50.59 evaluations such as; Rev. 1 of NEI 96-07 includes examples to illustrate and reinforce the guidance. Inspectors should consider that the examples are not always applicable for all licensees. If a licensee uses an example described in NEI 96-07 rev. 1 or another approach as part of the evaluation, the inspector should ensure that the approach is applicable to its particular circumstance as described in the content of NEI 96-07 rev. 1.

Date: December 1, 2020 25 0335