Text

NEI Feedback on Draft IMC-0335 12/21/2020
	ML21006A309
Person / Time
Site:	Nuclear Energy Institute
Issue date:	12/21/2020
From:	; Nuclear Energy Institute
To:	; Office of Nuclear Reactor Regulation
	Tekia Govan, NRR/DRO/IRAB, 301-415-6197
Shared Package
ML21006A246	List: ML21006A308; ML21006A309;
References
	IMC-0335
	Download: ML21006A309 (15)
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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 0335-04 DEFINITIONS In the definition of MOE, the elements from NEI 96-07 rev. 1 are included however Consider adding the additional information additional information that is also referenced would be useful to the inspector. from NEI 96-07, 3.10 to the MOE definition.

0335-04, page 2, Changes to such methods of evaluation require evaluation under 10 CFR Definitions 50.59(c)(2)(viii) only for evaluations used either in UFSAR safety analyses or in 1 04.03 Methods of establishing the design bases, and only if the methods are described, outlined or Evaluation 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.

04.06, page 3, The title should include the term general licensees in addition to ISFSI or MRS Add general licensees to the title.

2 facility to describe all of the licensee types.

Definitions Final Safety Analysis Report (as updated) definition should include the UFSAR for Consider adding in 10 CFR72.48 elements to CoC holders and for general licensees. this definition or having a separate definition for this aspect.

Example: Updated Final Safety Analysis Report (UFSAR) (10 CFR 72.48) - FSAR (as updated) means:

for specific licensees, the Safety Analysis Report for a facility submitted and updated in accordance with 10 CFR 72.70 04.07, page 3,

for general licensees, the Safety Analysis Report for a spent fuel storage cask 3

Definitions 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.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 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.

Since NEI 97-04, rev. 1 Appendix B, Guidance and Examples for Identifying 10 CFR Consider adding a note that references NEI 97-0335-04, page 4, 50.2 Design Bases is endorsed by RG 1.186, Guidelines and Examples for 04, Rev, 1, Appendix B, Guidance and Definitions Identifying 10 CFR 50.2 Design Bases, there may be value having it referenced for Examples for Identifying 10 CFR 50.2 Design 04.13, Design NRC inspectors. Bases (endorsed by RG 1.186) for more 4 Function, 04.14, information on these definitions.

Design bases NEI 97-04 rev. 1 Appendix B endorsed by RG 1.186 contains useful information on functions, 04.15, these design bases/function definitions.

Design Bases 06.05 describes the relationship between 50.59 & 50.155. It may be beneficial to Consider adding a definition for beyond the 0335-04, page 4, include; beyond the design basis events to the definition section. This could help design basis events and that they are not 5

Definitions inspectors especially when these are described in the UFSAR. subject to 50.59 04.16, page 4, Malfunction of SSCs important to safety is missing that non-safety related (NSR) Add NSR to the definition as described in NEI 6 SSC need to be considered as part of this definition. 96-07 rev.1.

Definitions 2

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 0335-06 10 CFR 50.59 PROCESS There is no information that describes the relationship between 50.59 and Add a section describing the relationship 0335-06, page 5, Surveillance Frequency Control Program (SFCP). Adding details including between 50.59 and the Surveillance Frequency 7 10 CFR 50.59 implementation lessons learned similar to the relationship between 10 CFR 50.59 Control Program (SFCP).

process and Fire Protection could be beneficial.

Consider adding clarification when 50.59 is used as part of a TS bases change that Add the following statement to the end of this 06.02, page 6, it cannot directly conflict with the as-stated requirements of the TS. section; A TS bases change cannot be made Relationship pursuant to 10 CFR 50.59 that directly conflict 8 between 10CFR This will help inspectors distinguish between how 50.59 is used to support TS with the as-stated requirements of the TS.

50.59 and Tech bases changes.

Spec basis This section references RG 1.186, Guidelines and Examples for Identifying 10 CFR Add NEI 97-04 rev. 1, Appendix B as a 06.03, page 6, 50.2 Design Bases but not NEI 97-04 rev.1, Appendix B, Guidance and Examples reference to this section since it is endorsed by Relationship for Identifying 10 CFR 50.2 Design Bases RG 1.186.

9 between 10 CFR 50.59 and 10 CFR NEI 97-04 rev. 1 Appendix B endorsed by RG 1.186 contains useful information on 50.2 Design Bases these design bases/function definitions.

Additional clarification may be useful to the inspectors regarding this relationship. Consider adding the following statement at the end of the paragraph; 10 CFR 50.59 is not 10 CFR 50.59 is not applicable to SSCs that have only beyond-design-basis- applicable to SSCs that have only beyond-06.05, page 7, functions, do not interact with SSCs with design basis functions (i.e., there are design-basis-functions, do not interact with Relationship physical separations and separation of power, instrumentations and controls), and SSCs with design basis functions (i.e., there are 10 between 50.59 credibility of adverse impact arising from modification of these beyond-design- physical separations and separation of power, and 50.155 basis SSCs to the important to safety SSCs are precluded. 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.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation This section is listed after 06.01 - 06.05 that describes regulations that contain Consider making 06.06 and overarching 06.06, page 8, control processes and the applicability determination process. It may benefit section that contains the information 11 Applicability inspectors to have this as the header to sections 06.01-06.05 since those described described in 06.01-06.05 in addition to the Determination applicability determinations. content in 06.06.

06.06, page 8, In this sections and other sections throughout. The terms CTE is used when Consider in this section (any other sections) 12 Applicability activity may be better in describing the proposed CTE. the use of proposed activity versus Determination proposed CTE 3rd paragraph states that; If a change has no effect or has Consider changing underlined text to is not only beneficial effects, it does not trigger any of the evaluation criteria concerning more than a minimal increase in frequency or more than minimal increase in frequency or occurrence of malfunction or higher occurrence of malfunction consequences, etc 06.08 page 9, Changes to the 13 May be better worded as; If a change has no effect or has facility or only beneficial effects, it is not more than a minimal increase in frequency or procedures occurrence of malfunction.

This may improve clarity for the inspectors.

Last paragraph in 06.09 states; However, testing that removes an SSC from Remove if it is not a prolonged removal from service for maintenance, if it is not a prolonged removal, does not require a 10 CFR statement.

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

06.09, page 11, Tests and The point of this section is to ensure that inspectors understand that removing 14 Experiments not equipment from service is controlled under 10CFR50.65(a)(4). Reinforcing the described in the point about prolonged removal doesnt seem to fit the intent of this section and is UFSAR not a defined term. Considering referring to section 6.20 when assessing maintenance activities.

In the 1st paragraph, inspectors may benefit from language included under 72.48 Add this information to the first paragraph; section (page 37) to make it clear how the 50.59 criteria are assessed.

06.10, page 11, 15 If the 10 CFR 50.59 screening for the Evaluation Process If the 10 CFR 50.59 screening for the proposed activity concludes that a change to proposed activity concludes that a change to an MOE is not involved, then the 10 CFR 50.59 evaluation should reflect that 10 an MOE is not involved, then the 10 CFR 50.59 4

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation CFR 50.59(c)(2)(viii) is not applicable. If the 10 CFR 50.59 screening determines evaluation should reflect that 10 CFR that the proposed activity involves only a change to an MOE, then the 10 CFR 50.59(c)(2)(viii) is not applicable. If the 10 CFR 50.59 evaluation should reflect that criteria 10 CFR 50.59(c)(2)(i) through (vii) are 50.59 screening determines that the proposed not applicable. 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.

2nd to last paragraph states; Each element of a CTE should be separately Consider changing CTE to proposed 06.10, page 11, evaluated against each of the 10 CFR 50.59(c)(2) criteria unless the elements of a activity in this paragraph.

16 Evaluation CTE are interdependent.

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

This section may benefit from the reinforcement that alteration of the design Consider reinforcing the information 06.11, page 12, basis limit for a fission product barrier (DBLFPB) requires prior NRC approval via a contained on page 19 in this section that any 17 Minimal Increase license amendment. change to the DBLFB is adverse Principle The following wording changes will help inspectors understand how the SOCs The following changes would better align with apply without limiting the use of PRA or other risk insights that would be the intent of the SOC and not cause confusing appropriate in supporting 50.59 evaluations. The current wording appears to on how PRA may be used in support a 50.59 extend beyond the intent of the SOCs and would add additional restrictions on the evaluation.

use of PRA methods.

1. Change RG 1.174 or its values to; RG

1. Consistent with the Commissions statements supporting the final 10 CFR 50.59 1.174 to determine values 06.12 page 13, rule, inspectors should verify that licensees did not use RG 1.174 or its values for 18 PRA and risk change in CDF and/or LERF as the basis for 10 CFR 50.59 evaluations. 2. Change are not acceptable to inform to; insights are not acceptable as the sole basis to While we understand the intent of this statement, its values could be inform misinterpreted as meaning that the same values as described in RG 1.174 derived from another source would not be allowable.

Recommend clarifying by stating; inspectors should verify that licensees did not use RG 1.174 to determine values for changes in CDF and/or LERF used during 10 CFR 50.59 evaluations.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation

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 It would be beneficial to inspectors to include more detail on how the GDC relates Add clarification to these sections that 06.13, page 14, to the CLB in these sections and what to expect by the licensee during the 50.59 describes the relationship between the GDC (criterion i) evaluation. and CLB and that a licensees evaluation 19 06.14, page 15, should demonstrate how the minimum (criterion ii) performance standards continue to be met as part of the evaluation of this criterion.

Consider adding the following statement to this section to aid inspectors with Add the following to section; For changes additional guidance contained in NEI 96-07 rev. 1 Sect 4.3.3 defining what is affecting the dose to operators performing considered more than a minimal increase. required actions outside the control room, an 06.15, page 15, increase is considered more than minimal if 20 (criterion iii & iv) NEI 96-07 sect. 4.3.3. For changes affecting the dose to operators performing the resultant mission dose exceeds required actions outside the control room, an increase is considered more than applicable GDC 19 criteria.

minimal if the resultant mission dose exceeds applicable GDC 19 criteria.

The following statement in the 2nd paragraph appears to be misplaced. Delete the following statement; Changes in methodology used to calculate radiological Changes in methodology used to calculate radiological consequences would fail consequences would fail criterion (viii) of 06.15, page 16, 21 criterion (viii) of 10 CFR 50.59 and require prior NRC review regardless of how 10 CFR 50.59 and require prior NRC review (criterion iii & iv) small the increase is in the calculated radiological consequences. regardless of how small the increase is in the calculated radiological consequences.

If the intent is to keep this statement, it should be modified to state; 6

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation If intent is to keep it, consider the following Changes in methodology used to calculate radiological consequences would be for clarification; Changes in methodology evaluated under criterion (viii) of 10 CFR 50.59 and require prior NRC review used to calculate radiological consequences regardless of how small the increase is in the calculated radiological consequences. would fail be evaluated under criterion (viii) of 10 CFR 50.59 and require prior NRC review This terminology would better align with guidance. regardless of how small the increase is in the calculated radiological consequences.

The following information from NEI 96-07 rev. 1 Section 4.3.6 will aid inspectors Add the following to the beginning of 06.17 with understanding aspects that describe this criterion.

Malfunctions of SSCs are generally postulated Malfunctions of SSCs are generally postulated as potential single failures to as potential single failures to evaluate plant evaluate plant performance with the focus being on the result of the malfunction performance with the focus being on the rather than the cause or type of malfunction. A malfunction that involves an result of the malfunction rather than the cause initiator or failure whose effects are not bounded by those explicitly described in or type of malfunction. A malfunction that 06.17, page 18, 22 the UFSAR is a malfunction with a different result. A new failure mechanism is not involves an initiator or failure whose effects (Criterion vi) a malfunction with a different result if the result or effect is the same as, or is are not bounded by those explicitly described bounded by, that previously evaluated in the UFSAR. 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.

Adding a statement such as; timeliness of corrective actions is evaluated under 10 Consider adding a statement; Timeliness of CFR Appendix B, Criterion XVI. corrective actions is evaluated under 10 CFR Appendix B, Criterion XVI.

06.20, page 23, This would align with the PI&R inspection guidance and what governs how 23 Maintenance timeliness of corrective actions should be assessed.

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

06.20, page 23, 2nd paragraph, the use of proposed activity may be more appropriate than CTE Consider changing CTE to proposed 24 (similar to overall note) activity.

Maintenance 7

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation Activities The use of CTE doesnt seem to fit this section as well.

The following descriptions from Part 9900 for 50.59 could aid the inspectors on Consider adding additional elements from (or considerations for determining when equipment removed from service for referencing) Part 9900, 50.59.

maintenance could become a change that would need to be assessed under 50.59.

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 06.20, page 23, 25 24, Maintenance The reliance upon the Paragraph 50.65(a)(4) assessment in lieu of a section 50.59 Activities 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.

0335-07 10 CFR 72.48 PROCESS 0335-07, page 25, First bullet discusses NEI 12-04 but doesnt mention RG 3.72. Add reference to RG 3.72 in this section that 26 10 CFR 72.48, first

Applicability and Screening: Licensees and CoC holders may follow these endorses NEI 12-04. (e.g., RG 3.72 rev. 1 bullet processes, as described in NEI 12-04, to determine if another process endorses NEI 12-04, rev. 2) 8

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 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.

Section may benefit from the following re-wording. It also has a better tie to Suggested wording improvements for this general licensees. overview.

Each 10 CFR 72 General Licensee stores spent nuclear fuel in Spent Fuel Storage Or specific changes to consider if the original Canisters/Casks in an Independent Spent Fuel Storage Installation (ISFSI) licensed to wording is maintained.

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 0335-07, page 25, canisters/ISFSI described in the UFSAR are identified within the 72.212 report and 27 10CFR72.48 reviewed under 10 CFR 72.48. The loaded canisters/casks and ISFSI remain licensed process 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.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation Note - If decision to keep the original language, the next 3 comments address how to improve them as written.

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 Revise to reflect no regulatory review needed decides whether no regulatory review is required at all (i.e., for editorial or for editorial or administrative changes.

administrative changes).

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

07.01, page 25, Title references 72.78 versus 72.48 Change 72.78 to 72.48.

Relationship 28 between 50.59 Typo.

and 72.48 1st para.: The reference to using 0335-06 for 72.48 should be clarified by adding Add phrase as suggested 07.01, page 25, consistent with the endorsed guidance in NEI 12-04.

Relationship 29 between 50.59 There are some elements of the 50.59 rule and guidance that do not apply to and 72.48 72.48.

07.01, page 25, The 2nd paragraph, 2nd sentence should also be included in 0335-06, with Add sentence in 07.01 to the language in Relationship appropriate re-wording for the 50.59 program because changes made to SSCs 0335-06 to reflect interplay between 50.59 30 between 50.59 under 50.59 can also affect the ISFSI and require 72.48 review. and 72.48.

and 72.48 1st para.:

a) It is not clear why Part 71, Subpart H is included here. Seems like Part 72, a) Suggest deleting Subpart H.

07.02, page 25, Subpart G is all that should be referenced. Suggest deleting this discussion to avoid Relationship 31 confusion and inappropriate mixing of Part 71 and 72 requirements.

between 72.48 and QA program b) Change or implementation of 10 CFR 72.212 evaluation to or implementation (b) Revise wording as suggested of a Part 72 general license.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation The purpose of this section is not clear. It provides discussion of dual-purpose Consider removing this section or add 07.03, page 26, systems but then concludes Part 71 is outside the scope of the IMC. Suggest additional information on what it is included Relationship deleting this section to avoid confusion and inappropriate mixing of Part 71 and 72 for the inspector.

between 72.48 requirements.

32 and transportation Is the intent to reinforce this aspect? Inspectors should be aware of changes to (part 71) activities that affect Part 71 design and licensing bases and will need to be assessed and controlled under Part 71 requirements.

07.05, page 27, 1st para.: Suggest deleting the last sentence. This may be colloquially true, but Suggest deleting section as unnecessary and to Relationship there are too many differences between a 212 report and a specific ISFSI license avoid confusion.

33 between 72.48 & UFSAR to make this statement.

72.212 2nd para.: (a) Clarify as suggested.

a) Add clarification as to whether parts of the 212 report not governed by (b) Add reference as suggested.

72.212(b)(5) and (b)(6) are or are not governed by 72.48. The 212(b)(7) regulation (c) Add clarification on how NRC interprets a 07.05, page 27, seems to be narrowly written to apply to just these sections of the 212 report. deviation from a cask UFSAR with respect to Relationship 34 b) Suggest adding a reference to RIS 2012-05. evaluations in the 212 report.

between 72.48 &

c) Implementation of 212(b)(7) has been the source of recent enforcement action 72.212 for general licensees. Suggest adding more clarity as to how the NRC interprets a deviation from the cask UFSAR with respect to evaluations in the 212 report.

Consult RIS 2012-05 in this regard.

3rd para.: The point being made in the penultimate sentence is not clear and the Delete sentence as suggested.

sentence seems to be misplaced. General licensee site-specific deviations from the 07.05, page 27, cask FSAR authorized under 72.48 are not included in a modification to the generic Relationship 35 cask FSAR. Each general licensee tracks these independently. Suggest deleting this between 72.48 &

sentence. The relationship between the cask UFSAR, the 212 report, and 72.48 is 72.212 adequately addressed in the previous paragraph.

For general licensees, other regulations (e.g., 10 CFR 50.54) also applies for some Suggest either adding the additional 07.06, page 27, programs. While only some examples of these regulations that contain a change regulations or referencing back to NEI 12-04 36 Applicability control process in Part 72 regulations are listed in this section, NEI 12-04 list is Sect. 4.1.

Determination more comprehensive.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 5th paragraph states that Inspectors should recognize that changes reducing an Add; in the accomplishment of its as-credited SSCs capability, performance, qualification, or reliability are adverse. design function to distinguish between changes that do not affect a credited design 07.08, page 28, May be better worded as; Inspectors should recognize that changes reducing an function from ones that do.

Changes to the SSCs capability, performance, qualification, or reliability in the accomplishment of 37 facility or to its as-credited design function is adverse.

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

Last para.: The term unintended change is not in the regulations, RG 3.72 or NEI Suggest explaining the term using existing 07.08, page 29, 12-04. definitions, providing a new definition in the Changes to the 38 appropriate document, or otherwise more facility or to It would not be clear to inspectors what this is intending. fully explaining the issue and the process to be procedures followed.

In the 1st paragraph, inspectors may benefit from language included later under Add this information to the first paragraph; 72.48 section 07.20 (page 37) to make it clear how the 72.48 criteria are assessed.

If the 10 CFR 72.48 screening for the If the 10 CFR 72.48 screening for the proposed activity concludes that a change to proposed activity concludes that a change to an MOE is not involved, then the 10 CFR 72.48 evaluation should reflect that 10 an MOE is not involved, then the 10 CFR 72.48 07.10, page, 29, CFR 72.48(c)(2)(viii) is not applicable. If the 10 CFR 72.48 screening determines evaluation should reflect that 10 CFR 39 Evaluation Process that the proposed activity involves only a change to an MOE, then the 10 CFR 72.48(c)(2)(viii) is not applicable. If the 10 CFR 72.48 evaluation should reflect that criteria 10 CFR 72.48(c)(2)(i) through (vii) are 72.48 screening determines that the proposed not applicable. 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.

1st para.: Delete or CoC holder from the last sentence. Delete phrase as suggested.

07.10, page, 29, 40 Evaluation Process CoC holders do not request license amendments per 72.56.

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NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 3rd para.: At the beginning of the 2nd sentence, add While the SER does not Add phrase as suggested.

impose requirements on the licensee or CoC holder, inspectors 07.10, page, 29, 41 Evaluation Process Improves guidance.

4th para.: The 2nd bullet does not clearly describe the two separate types of MOE Revise as described.

changes as described in the definition of a departure from an MOE in the regulations. Suggest revising to refer to 1) A change to an element of a method 07.10, page, 30, 42 described in the UFSAR or 2) a different method from that described in the UFSAR.

Evaluation Process This will provide better guidance in this area.

Most ISFSIs and cask designs were not licensed per NUREG-2215. Suggest replacing Replace reference as suggested.

this reference with a reference to the applicable SRP for the ISFSI license or cask 07.11, page 30, design CoC.

43 minimum increase principle Improves inspector guidance.

The blanket reference to Section 06.12 is not applicable for 72.48. PRA does not Suggest adding Part 72-specific guidance on apply to Part 72 and the NRC asked that we remove references to PRA from NEI use of PRA.

07.12 page 30, 12-04. Suggest adding Part 72-specific guidance to inspectors for licensee use of 44 PRA and risk probabilistic analysis techniques, including any limitations.

insights May cause confusion to inspectors as written.

0335-07.13 thru Reg Guide 3.72, Revision 1 has exceptions and clarifications that apply to the 72.48 Consider a broad review of these sections to 20 criteria that should be recognized in the appropriate sections to help the include applicable exceptions and clarifications inspectors during the inspection activity. form RG 3.72, Rev.1.

45 This will aid inspectors during inspection activities 13

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 0335-09 REFERENCES The following guidance documents are not listed in the references. Consider adding additional references as

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

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 0335-09, page 40, 46 CFR 50.2 Design Bases References

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

GENERAL COMMENT

S Use of NEI 96-07 should reference revision 1 to ensure clarity of endorsed Add revision 1 when NEI 96-07 is referenced.

guidance.

OR OR Include a statement that the inspectors should 47 General comment If revisions were not intended to be use, statements that reflect that the latest reference the latest endorsed references for endorsed guidance should be used. their use.

Minimize the potential for inspectors to reference outdated information Since this inspection manual is to inspect all activities related to 50.59, including Add information and references to reflect 48 General comment information from NEI 96-07 Appendix D and associated rev. 2 of RG 1.187 would digital I&C 50.59 related activities.

benefit inspectors inspecting areas associated with digital I&C.

In Section 6.13 and 6.14, the examples in NEI 96-07 rev.1 are not included. This is Add info to ensure the inspectors understand 49 General comment ok but it would be good to make a statement in the IMC similar to RG 1.187 that how to consider examples referenced in 50.59 the examples in NEI 96-07 are meant to illustrate and reinforce the concepts evaluations such as; 14

NEI Comments on Draft IMC-0335, Changes, Tests and Experiments Item Affected Section Comment/Basis Recommendation 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, Rev. 1 of NEI 96-07 includes examples to inspectors should ensure the approach taken is applicable to its particular illustrate and reinforce the guidance.

circumstance as described in the content of NEI 96-07 rev.1. 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.

Inspectors may benefit from adding a description of the transition from 50.59 to Consider adding more detail to the transition 50 General comment 72.48 during fuel related activities. from 50.59 to 72.48.

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GENERAL COMMENT

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