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{{#Wiki_filter:1 NRR-DMPSPEm Resource From:FREGONESE, Victor <vxf@nei.org>
{{#Wiki_filter:NRR-DMPSPEm Resource From:                           FREGONESE, Victor <vxf@nei.org>
Sent: Wednesday, August 16, 2017 4:05 PM To: Morton, Wendell; Rahn, David
Sent:                           Wednesday, August 16, 2017 4:05 PM To:                             Morton, Wendell; Rahn, David


==Subject:==
==Subject:==
[External_Sender] FW: NRC Draft Regula tory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
[External_Sender] FW: NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
Attachments:
Attachments:                     08-16-17_NRC_NEI 17-XX-Industry-Comments-NEI-Cover Letter.pdf; 08-16-17
08-16-17_NRC_NEI 17-XX-Industry-Comment s-NEI-Cover Letter.pdf; 08-16-17
_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-General Comments_Attachment1.pdf; 08-16-17_NRC_NEI_17-xx-Consolidated Industry Comment-8-16-17-Editorial Comments_Attachment2.pdf; 08-17-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-Clarification Comments_Attachment3.pdf Vic Fregonese Senior Project Manager Nuclear Generation Division Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004 www.nei.org M: 704-953-4544 E: vxf@nei.org From: HANSON, Jerud Sent: Wednesday, August 16, 2017 4:04 PM To: cindy.bladey@nrc.gov Cc: Jason.Drake@nrc.gov; john.lubinski@nrc.gov
_NRC_NEI 17-xx-Consolidated Indu stry Comment-8-16-17-General Comments_Attachment1.pdf; 08-16-17_NR C_NEI_17-xx-Consolidated Industry Comment-8-16-17-Editorial Comments_At tachment2.pdf; 08-17-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-Cl arification Comments_Attachment3.pdf Vic Fregonese Senior Project Manager Nuclear Generation Division  


Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004 www.nei.org M: 704-953-4544 E: vxf@nei.org From: HANSON, Jerud Sent: Wednesday, August 16, 2017 4:04 PM To: cindy.bladey@nrc.gov Cc: Jason.Drake@nrc.gov; john.lubinski@nrc.gov
==Subject:==
NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
THE ATTACHMENT CONTAINS THE COMPLETE CONTENTS OF THE LETTER August 16, 2017 Ms. Cindy Bladey Mail Stop: TWFN-8 D 36M Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555-0001


==Subject:==
==Subject:==
NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
THE ATTACHMENT CONTAINS THE COMPLETE CONTENTS OF THE LETTER August 16, 2017  
Project Number: 689
 
==Dear Ms. Bladey:==
 
1
 
The Nuclear Energy Institute (NEI)[1] and the industry appreciate the opportunity to provide integrated industry comments on the Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22. The purpose of this RIS is to clarify the NRCs endorsement of NEI 01-01 by providing additional guidance for preparing and documenting the qualitative assessment used to provide reasonable assurance that a digital modification will exhibit a low likelihood of failure, which is a key element in 10 CFR 50.59, Changes, tests and experiments, evaluations of whether the change requires prior NRC approval. This RIS supports our mutual interest in more efficient and effective licensing of digital upgrades across the operating fleet and we look forward to issuance in the third quarter of 2017. Our principal comments are included below and more detailed comments are presented in the attachments for consideration by the NRC staff.
We appreciated the opportunity to participate in a public meeting to conduct a tabletop exercise utilizing the draft RIS 2002-22 Supplement for Digital I&C upgrades at nuclear power reactor facilities under 10 CFR 50.59 on August 2, 2017. The draft RIS provided an effective framework for conducting digital upgrades within the scenarios that were demonstrated.
We appreciate the opportunity to comment on the Draft RIS. If you have any questions or require additional information, please contact me.
Sincerely, Jerud Hanson Senior Project Manager, Life Extension & New Technology Nuclear Energy Institute 1201 F Street N.W., Suite 1100 Washington, DC 20004 www.nei.org P: 202.739.8053 M: 202.497.2051 E: jeh@nei.org The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link points to the correct file and location.
This electronic message transmission contains information from the Nuclear Energy Institute, Inc. The information is intended solely for the use of the addressee and its use by any other person is not authorized. If you are not the intended recipient, you have received this communication in error, and any review, use, disclosure, copying or distribution of the contents of this communication is strictly prohibited. If you have received this electronic transmission in error, please notify the sender immediately by telephone or by electronic mail and permanently delete the original message. IRS Circular 230 disclosure: To ensure compliance with requirements imposed by the IRS and other taxing authorities, we inform you that any tax advice contained in this communication (including any attachments) is not intended or written to be used, and cannot be used, for the purpose of (i) avoiding penalties that may be imposed on any taxpayer or (ii) promoting, marketing or recommending to another party any transaction or matter addressed herein.
2


Ms. Cindy Bladey Mail Stop: TWFN-8 D 36M Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555-0001  
Sent through www.intermedia.com
[1]
The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.
3
 
Hearing Identifier:  NRR_DMPS Email Number:        185 Mail Envelope Properties    (41207040FCA6A84984074E806C73D73EE20B13)
 
==Subject:==
[External_Sender] FW: NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
Sent Date:            8/16/2017 4:05:06 PM Received Date:        8/16/2017 4:05:32 PM From:                FREGONESE, Victor Created By:          vxf@nei.org Recipients:
"Morton, Wendell" <Wendell.Morton@nrc.gov>
Tracking Status: None "Rahn, David" <David.Rahn@nrc.gov>
Tracking Status: None Post Office:          mbx023-e1-nj-2.exch023.domain.local Files                        Size                    Date & Time MESSAGE                      4366                    8/16/2017 4:05:32 PM 08-16-17_NRC_NEI 17-XX-Industry-Comments-NEI-Cover Letter.pdf                    54333 08-16-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-General Comments_Attachment1.pdf                    74548 08-16-17_NRC_NEI_17-xx-Consolidated Industry Comment-8-16-17-Editorial Comments_Attachment2.pdf                    105134 08-17-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-Clarification Comments_Attachment3.pdf                    206858 Options Priority:                    Standard Return Notification:          No Reply Requested:              No Sensitivity:                  Normal Expiration Date:
Recipients Received:
 
JERUD E. HANSON Senior Project Manager, Life Extension & New Technology 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8053 jeh@nei.org nei.org August 16, 2017 Ms. Cindy Bladey Mail Stop: TWFN-8 D 36M Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555-0001


==Subject:==
==Subject:==
NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)
Project Number: 689


Project Number: 689
==Dear Ms. Bladey:==


==Dear Ms. Bladey:==
The Nuclear Energy Institute (NEI) 1 and the industry appreciate the opportunity to provide integrated industry comments on the Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22. The purpose of this RIS is to clarify the NRCs endorsement of NEI 01-01 by providing additional guidance for preparing and documenting the qualitative assessment used to provide reasonable assurance that a digital modification will exhibit a low likelihood of failure, which is a key element in 10 CFR 50.59, Changes, tests and experiments, evaluations of whether the change requires prior NRC approval. This RIS supports our mutual interest in more efficient and effective licensing of digital upgrades across the operating fleet and we look forward to issuance in the third quarter of 2017. Our principal comments are included below and more detailed comments are presented in the attachments for consideration by the NRC staff.
We appreciated the opportunity to participate in a public meeting to conduct a tabletop exercise utilizing the draft RIS 2002-22 Supplement for Digital I&C upgrades at nuclear power reactor facilities under 10 CFR 50.59 on August 2, 2017. The draft RIS provided an effective framework for conducting digital upgrades within the scenarios that were demonstrated.
1 The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.
 
Ms. Bladey August 16, 2017 Page 2 Application to safety-related systems The scope of the RIS and attachment should be clearly stated as intended to be used for safety-related systems only. It should be clear that the RIS could, or might be used as guidance for non-safety related upgrades only if desired by licensees. Therefore, industry requests that the RIS should provide sufficient clarity to avoid an interpretation that it is viewed as mandatory for non-safety related systems. Comment
#1 within attachment #1, provides suggestions to address this point.
Impact on digital system common cause failure The draft RIS is characterized as a means to allow for low risk (non-protection systems) changes to safety systems to go forward under 50.59, but there is no discussion of risk considerations. Instead, it includes a recommended level of rigor for the engineering evaluations needed to support the 50.59 process without providing any assurance that these will be accepted for low risk systems. These low risk systems have been incorrectly included in the current NRC staff position on common cause failure (CCF) policy, due to changes over time to Branch Technical Position (BTP) 7-19. It should be clearly stated how the RIS impacts the current NRC policy/position that addresses digital system CCF. Comment #2 within attachment #1, provides suggestions to address this point.
Application to non-power reactors This RIS should be applicable to include non-power reactors (NPRs). Relevant guidance contained within NEI 96-07 and RG 1.187 is applicable to NPRs, and digital upgrades at NPRs should be addressed within this RIS. Comment #3 within attachment #1, provides suggestions to address this point.
We appreciate the opportunity to comment on the Draft RIS. If you have any questions or require additional information, please contact me.
Sincerely, Jerud E. Hanson Attachments c:      John W. Lubinski, NRR, DE c:      Jason Drake, NRR, DE
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - General Comments Comment No. Section/Page #                                Industry Comment                                          Recommended Change
: 1. General        The scope of the RIS and attachment needs to be limited to safety-related    Clearly state the applicability of the RIS and systems only.                                                                attachment is intended to be used for safety It should be very clear that the RIS could, or might be used as guidance for  related systems only.
non-safety related upgrades if desired. The RIS should provide sufficient clarity to avoid an interpretation that it is to be viewed as mandatory for non-safety related systems.
: 2. General        The Draft RIS was characterized as a means to allow for low risk (non        Describe how the RIS impacts the current protection systems) changes to safety systems to go forward in 50.59, but    NRC policy/position documents that address there is no mention of any sort of risk considerations in the Draft RIS.      digital system CCF, such that end users of Instead it mainly provides a recommended level of rigor for the engineering  the RIS are clear how, or if, other NRC CCF evaluations needed to support the 50.59 without providing any assurance      policy/position documents apply to the that these will be accepted for low risk systems that have been incorrectly activities within the scope of the RIS.
pulled into the CCF policy due to changes to BTP 7-19. Nowhere in this RIS is a statement on scope of the policy on CCF, in fact it seems to reinforce the current content of BTP 7-19 into not only safety related components but non safety components that are in the licensee design basis.
1
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - General Comments Comment No. Section/Page #                            Industry Comment                                            Recommended Change
: 3. General        The non-power reactor community was not included in consideration of this      Please include non-power reactors within RIS.                                                                          the scope of the RIS.
At the May 25, 2017 public meeting on this proposed RIS there was discussion of the importance of including non-power reactor licensees within this proposed RIS. The general consensus was that non-power reactors should be included within its scope. It appears that the exclusion of non-power reactors from RIS 2002-22 was likely an oversight. EPRI TR-102348 and Generic Letter 95-02 are referenced in NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, for use by the non-power NRC staff and licensees in licensing DI&C upgrades. Though they followed after the issuance of NUREG-1537, the revision to EPRI TR-102348 (NEI 01-01) and related RIS 2002-22 are also used by the non-power NRC staff and licensees in licensing DI&C upgrades. NEI 96-07 and associated RG 1.187 are also applicable to non-power reactor licensees.
: 4. General        The RIS does not specify whether the NRC expectation is that the              Add a statement that the RIS is intended to Qualitative Assessment guidance is to be used for 50.59 screening.            be used for 50.59 evaluations, but may be consulted during the 50.59 screening process.
2
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                                  Industry Comment                                            Recommended Change
: 1. Draft RIS Page 1 In the ninth line of this paragraph, please augment the implicit statement of    Replace  this RIS is to clarify the NRCs Intent Paragraph applicability to ensure that the reader recognizes that RIS 2002-22 is being  endorsement of NEI 01-01 with  this supplemented rather than supplanted. The text does not make this              supplemental RIS clarifies still-active RIS extremely clear and unambiguous.                                              2002-22 that endorsed NEI 01-01
: 2. Draft RIS Page 2  Background Information section, first full paragraph, Correct the title of NEI Correct text as noted.
Section titled    96-07, Evaluations should be Implementation.
 
===Background===
Information
: 3. Draft RIS Page 3  At the end of the last sentence in the paragraph starting Specifically, this  Revise from  methods to demonstrate the Section titled    RIS add words that clarify that the problem is in software.                  likelihood of failure Summary of                                                                                      To Issue Section
                                                                                                          .methods to demonstrate the likelihood of failure from software design errors
: 4. Draft RIS Page 4 For readability, please consider bolding these italicized section headers to    Use bold text for section headers.
Section titled    make them stand out in the rest of the text.
Clarification of Guidance for Addressing Digital I&C Changes under 10 CFR 50.59 1
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                                  Industry Comment                                            Recommended Change
: 5. Draft RIS Page 4 In the second full paragraph, second line, the word appropriate is            Replace appropriate with something more Section titled    ambiguous.                                                                    like applicable Clarification of Guidance for      The last sentence in this paragraph is very long.                              Split the last sentence into  applied to the Addressing Digital                                                                                proposed design. Using such standards I&C Changes under 10 CFR 50.59
: 6. Draft RIS Page 4 In the paragraph starting To assist licensees, the second line, the            Replace  the NRC staff has clarified Section titled    sentence should be simplified.                                                within the attachment to this RIS its Clarification of                                                                                position with  the attachment to this Guidance for                                                                                      RIS clarifies the NRC staff position Addressing Digital I&C Changes                                                                                      In the last sentence of this paragraph, delete under 10 CFR                                                                                      clarification within the as  the 50.59                                                                                            attachment describes is sufficient.
: 7. Draft RIS Page 4 In the next to last line of the first paragraph, it is not clear what alter the Replace alter the conclusions of by the Section titled    conclusions of means to a licensee.                                          safety analysis with alter the conclusions Clarification of                                                                                of or not be bounded by the safety analysis Guidance for                                                                                      in the UFSAR Addressing Digital I&C Changes under 10 CFR 50.59 2
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                                Industry Comment                                        Recommended Change
: 8. Draft RIS Page 4  In the first paragraph, please reiterate that this RIS supplements, but does Replace  supplements RIS 2002-22 Section titled    not supersede, RIS 2002-22.                                                  with  supplements but does not Backfitting and                                                                              supersede RIS 2022-22 Issue Finality Discussion      In the second paragraph, the first sentence does not define on whom the      Rework the first sentence in the second guidance might be imposed.                                                  paragraph.
: 9. RIS Attachment,  The first paragraph, first sentence is excessively long, with the result of  Replace  10 CFR 50.59 Rule, for use as page 1, Purpose being difficult to read and understand.                                      guidance for implementing with  10 CFR 50.59 Rule. This RIS provides guidance for implementing
: 10. RIS Attachment,  In the second paragraph, reinforce that this is a supplemental RIS.          Change  to provide clarifying guidance page 1, Purpose                                                                              with  to provide supplemental clarifying guidance Change Following this guidance will help with Following the guidance in the RIS 2022-22 and NEI 01-01, as augmented by the guidance in this RIS
: 11. RIS Attachment,  This second would be easier to find if it were set in bold type.            Change the format to bold on all section page 1,                                                                                        headers throughout the attachment, Likelihood                                                                                    including those that are underlined.
Justifications
: 12. RIS Attachment    In the first paragraph, last sentence, there are extra words, and a missing  Delete both that in the sentence, and Page 2,          reference to where the characteristics that should be evaluated are defined. replace there are some important with Regulatory                                                                                    several important.
Clarification                                                                                Provide some reference, even within the RIS, to the important characteristics that we should evaluate.
3
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                                  Industry Comment                                              Recommended Change
: 13. RIS Attachment    In the paragraph starting 10 CFR 50.59 (c)(2)(vi) in the fourth line, that is Replace  reasonable assurance the Page 3            missing.                                                                          likelihood with  reasonable assurance that the likelihood
: 14. RIS Attachment    Bullets contain quoted guidance from NEI 01-01 and NEI 96-07, Rev 1;              Revise bullets 1 and 3 to ensure the quoted Page 4, Section  however, in a couple cases, the quoted information is not correct.                text is accurate and traceable to the source 2.2, Step 1                                                                                        document.
: 15. RIS Attachment    Delete the entire paragraph beginning with: Documentation is needed..          Replace with the following:
Page 7, last paragraph                                                                                          Documentation is needed to demonstrate the proposed design will not create malfunctions with different results or initiate a different type of accident not previously analyzed in the UFSAR. Within the concept of layers of defense, acceptable justification for concluding an accident of a different type will not be initiated to include the postulated new accident is only possible after a sequence of multiple unlikely independent failures. This type of justification should also be documented as part of the qualitative assessment.
: 16. RIS Attachment    In the last line, a reference to the major section we are in is not helpful.      Either revise Section 4.2 to be more Page 8                                                                                              useful, or remove the reference to a general section in the RIS Attachment.
: 17. RIS Attachment    In the second paragraph, the subject (software and hardware) is plural.          Replace modification has with Page 8,Operating                                                                                  modification have Experience In the last sentence, the phrase along with consideration of the supplier of    Add commas before and after the phrase.
such equipment should be set off in leading and trailing commas.
4
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                                Industry Comment                                            Recommended Change
: 18. RIS Attachment  2nd paragraph.                                                                  Revise the following from:
Page 9, 4.2.1                                                                                    .do not result in a potential.
To:
do not result in more than minimal
: 19. RIS Attachment  In the first paragraph, last sentence, it might be clearer if the three steps in Please consider clarification of this Page 9, 4.2.1    the justification were numbered (e.g., 1) a thorough description of the ,      paragraph. Delete thorough.
: 2) the design attributes..., and 3) a clear description Further, it is not clear how extensive thorough is expected to be.
: 20. RIS Attachment  Sentence beginning with If the qualitative assessment..                        Revise the following from:
Page 10, 4.2.1.2                                                                                  ..a new type of accident, a malfunction with a new result, or an unbounded malfunction or accident now exists due to the combing of functions creating new malfunctions, or new inter-system interactions, etc, then..
To:
a new type of accident or, a malfunction with a different result now exists due to the combination of functions, then.
: 21. RIS Attachment  First paragraph.                                                                Revise the following from:
Page 10                                                                                          .the potential for new malfunctions or accidents should be evaluated.
To:
the potential for malfunctions with a different result or accidents of a different type should be evaluated 5
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                                Industry Comment                                        Recommended Change
: 22. RIS Attachment  The first sentence is too long.                                            Replace  development organization that Page 11, 1st                                                                                provides for common and repeated use, paragraph                                                                                  rules with  development organization.
These quality standards provide rules and move for common and repeated use to the end of the sentence, replacing context with context, for common and repeated use.
: 23. RIS Attachment  In the last sentence of the first paragraph, there are extraneous words and In the last sentence of the first paragraph, Page 11, 4.2.3  an imprecise set of references.                                            delete other avenues for performing the change, i.e.,  and list all avenues.
: 24. RIS Attachment  In the first sentence of the last paragraph, there are extraneous words. Replace  guidance provides the kind of Page 11, 4.2.3                                                                              process that should be engaged when using this guidance with .. guidance illustrates the process to use this guidance.
: 25. RIS Attachment  The diamond near the top of the page states Does the proposed change      Change the phrase to state Does the Figure 1        have the characteristics described in the attachment to the RIS?. It is    proposed change have the characteristics suggested that the characteristics being reference be pointed out        described in RIS attachment section 3?
specifically in the RIS attachment.
: 26. RIS Attachment  The second decision block language is not consistent with the verbiage      Revised the second decision block question Figure 1        used in 10 CFR 50.59.                                                      verbiage to align with 10 CFR 50.59.
6
 
INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page #                        Industry Comment                              Recommended Change
: 27. RIS Attachment  Step 1.                                                  Revise wording from:
Table 2                                                                  What are all of the UFSAR design functions..
To:
What are all of the UFSAR described design functions Alternatively, What are all of the design functions described in the UFSAR
: 28. RIS Attachment  Step 4, 2nd bullet.                                      Revise wording from:
Table 2                                                                  The digital components likelihood of postulated CCF likelihood To:
The digital components postulated CCF likelihood
: 29. RIS Attachment  Step 3.                                                  Revise wording from:
Table 2                                                                  Could those potential impacts already be bounded by the results of the design basis analyses, or would the analyses need to be revised to address it?
To:
Are potential impacts already bounded by results previously evaluated in the UFSAR or would the safety analyses need to be revised to address potential impacts?
7
 
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                        Recommended Change
: 1. ALL            The DRAFT RIS uses the term, qualitative assessment more than 15          Define the term qualitative assessment times throughout the RIS. In the context where it is used, in most case,    once, then only use the term in the balance either an implicit or explicit definition is stated. This is confusing.      of the text.
Also, in a few random cases effective qualitative assessment is used. This Suggest using a definition that states that DRAFT RIS does not define the differences between the two. Overall,          the purpose of the qualitative assessment is effective qualitative assessment seems out of place because either the    to demonstrate reasonable assurance of conclusions of a qualitative assessment support the outcomes when used in    adequate quality and low likelihood of failure a 10 CFR 50.59 Review or they do not                                        through a review of the system design process and design features. This would be consistent the with NEI 01-01 discussion of dependability (page 5-14).
For clarity and to avoid confusion, remove the word effective from effective qualitative assessment throughout the text.
1


2The Nuclear Energy Institute (NEI)
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                              Recommended Change
[1] and the industry appreciate the opportunity to provide integrated industry comments on the Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22. The purpose of this RIS is to clarify the NRC's endorsement of NEI 01-01 by providing additional guidance for preparing and documenting the "qualitative assessment" used to provide reasonable assurance that a di gital modification will exhibit a low likelihood of failure, which is a key element in 10 CFR 50.59, "Changes, tests and experiments," evaluations of whether the change requires prior NRC approval. This RIS supports our mutual interest in more effi cient and effective licensing of digital upgrades across the operating fleet and we look forward to issuance in the third quarter of 2017. Our principal comments are included below and more detailed comments are presented in the attachments for consideration by the NRC staff.  
: 2. ALL                The terms safety significance and safety significant are used throughout      Suggest using important to safety as this section without formal definitions.                                          defined in the UFSAR as it has a formal It is noted that use of these terms is limited to defining the level of           regulatory definition associated with the documentation that is worthwhile and is not used as input to answering the        design basis.
50.59 questions.
The scope of the draft RIS is such that the definition of safety significant is not consistent with its use in other regulatory applications The term safety significant as used in regulatory applications today generally has a definition that is much broader than just the licensing basis for the plant and often includes risk-insights (e.g., see the definition of safety significant in 10CFR50.69). Throughout the Qualitative Assessment Framework, review of the modification under 50.59 is restricted to the plant design basis as documented in the UFSAR. As the Qualitative Assessment Framework clearly is limited to the licensing basis for the plant and is neither risk-informed nor considers risk insights, the term safety significant should be avoided and replaced with a regulatory term having a formal definition applicable to the scope of this guidance, important to safety (as defined in the UFSAR).
: 3. Draft RIS          The term reasonable assurance is used here and in footnote 1. No basis          Remove the footnote, or, further define the Page 1            is provided for use of a different standard as used in the RIS, versus the        term adequate degree of certainty.
Intent Paragraph broader regulatory standard. What is the source for the footnote?
Identify the Regulatory sources of the Having different definitions of this term will cause confusion. As an example, footnote that clearly defines the difference the RIS uses the term reasonable assurance nearly 20 times throughout          between adequate degree of certainty and the document in various contexts. In many cases, the RIS includes quotes          broader NRC regulatory standard.
from NEI 01-01 with this term included.
2


We appreciated the opportunity to participate in a public meeting to conduct a tabletop exercise utilizing the draft RIS 2002-22 Supplement for Digital I&C upgrades at nuclear power reactor facilities under 10 CFR 50.59 on August 2, 2017. The draft RIS provided an effective framework for conducting digital upgrades within the scenarios that were demonstrated.
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                                Recommended Change
: 4. Draft RIS Page 2 In the third full paragraph, fifth line, reinforce the idea that this supplement is Replace This RIS supplements the NRC Section titled  to be used with RIS 2002-22.                                                        Staffs previous endorsement of the NEI 01-Background                                                                                          01 guidance with This RIS supplements Information                                                                                        the still-active RIS 2002-22 endorsement of NEI 01-01 guidance At the end of the paragraph, explain that this RIS is expected to provide the additional detail necessary to ensure resolution of the issues that have occurred when applying RIS 2002-22 and NEI 01-01.
: 5. Draft RIS Page 2 In the last full paragraph on this page, IAP MP #1 is mentioned in the              Explain how the CCF portion of the Section titled  context of 50.59.                                                                  modernization plan interacts with the 50.59 Background                                                                                          evaluation in the RIS discussion.
Information
: 6. Draft RIS        With respect to the text including the statement: there may be a potential        Clarify this statement to be clear that digital Page 3          for a marginal increase in the likelihood of malfunctions                          upgrades are not always expected to Summary of      Although this statement paraphrases NEI 01-01, Section 4.3.2, it seems to          increase malfunction likelihood.
Issue Section  imply that digital upgrades will always result in a marginal increase in malfunction likelihood. In practice, industry has observed the opposite - that      Rephrase to use the no more than minimal digital upgrades tend to decrease malfunction likelihood as most digital            increase text from 50.59.
upgrades eliminate single points of vulnerability, provide for signal validation, afford internal diagnostics and alarming capabilities - to name just a few characteristics that go beyond the capabilities of their analog counterparts.
This sentence may cause confusion within industry and with regional inspectors if it is interpreted to mean that digital upgrades are expected to increase malfunction likelihood.
3


We appreciate the opportunity to comment on the Draft RIS. If you have any questions or require additional information, please contact me.  
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                      Industry Comment                                          Recommended Change
: 7. Draft RIS            The sentence leading into the last paragraph on the page:                      Please clarify whether there is a change in Page 3                The RIS pulls out a statement from RIS 2002-22 and states that the Draft        NRC staff position from what was previously Section titled        RIS does not change NRC staff position, which apparently is that NEI 01-01      endorsed in NEI 01-01.
Summary of          provides an acceptable means. This seems to be at odds with the Issue Section        statements in the final two paragraphs of this section that the appendix will provide content, rationale and evaluating factors to be addressed, along with a short list of design attributes primarily drawn from the existing BTP 7-14.
: 8. Draft RIS             With respect to the text including the statement: ensuring that the            Suggest deleting this portion of the sentence uncertainty of qualitative assessments is sufficiently low                    as it may cause confusion.
Page 4, Section      What is meant by this statement? Generally speaking, the qualitative titled Clarification assessment is used to draw the conclusion that the digital change has a low of Guidance for      likelihood of failure.
Addressing Digital I&C Changes under 10 CFR 50.59
: 9. RIS Attachment /      The attachment seems to explicitly specify a quality process, structure and    In the Purpose section of the Attachment, Pages 1-17            format for the qualitative assessment that if left without clarification, could It should be made clear that the format, result in a significant impact on the industry in the areas of procedures,      content, and structure of the Attachment is qualification, and training, if the interpretation is that the qualitative      an example of what an acceptable assessment attributes are viewed as mandatory.                                 Qualitative Assessment could contain, and that the implementation details are up to the licensee.
4


Sincerely,  
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                  Industry Comment                                            Recommended Change
: 10. RIS Attachment / Outcomes from a qualitative assessment that would in turn be used as              Recommend that the outcome of a Pages 1-17      engineering/technical information in a 10 CFR 50.59 review are specified as      qualitative assessment be described as finds, final determination, resulting, etc. This inconsistent verbiage is  conclusions because conclusions are the confusing.                                                                        translation of the results. Therefore, the Examples of this are:                                                            conclusions of an assessment are the Section 2.1, last paragraph                                                      engineering/technical information that is Page 2 of 17, 3rd paragraph                                                      important to the 10 CFR 50.59 review.
Section 3, 1st paragraph
: 11. RIS Attachment  In section 2.1 (likelihood justifications) the attachment discusses the link      Recommend reconciling the use of Page 2, 1st      between dependability and likelihood of failures, but in the next to the last    reliability versus dependability in the Paragraph        paragraph, there seems to be an interchangeable use of reliability and            documents.
dependability, recommend sticking to dependability. Furthermore, the inclusion of reliability in the next to the last paragraph in this section is a miss-representation of NEI 01-01 which makes this point that for some high risk systems, there may be a need to provide additional assurance of adequate defense in depth and diversity. Since there is no mention of this, in the section, it can only be implied that all changes, without regard to risk will require a demonstration of defense in depth, but some systems do not require defense in depth because there is no requirement to do D3, but this could be construed to put that requirement onto the licensee.
: 12. RIS Attachment  This section discusses a reasonable assurance standard for evaluating low        Revise section to include a statement that Page 2, 3rd      likelihood of failure.                                                            captures the following concept:
Paragraph        Its important to note that the new digital equipment must only be as            The new digital equipment is not held to a reliable/dependable as the equipment it is replacing. The likelihood of failure  higher standard than the analog (or even is relative to the equipment being replaced.                                      digital) equipment it is replacing.
5


Jerud Hanson Senior Project Manager, Life Extension & New Technology
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                                Recommended Change
: 13. RIS Attachment  With respect to the text including the statement:                                  Remove this statement from the paragraph, Page 2, 7th    (whether or not classified as safety-related in accordance with 10 CFR Part      and if still necessary, place it elsewhere in Paragraph      50, Appendix B)                                                                  the text, in a context that is not tied to 50.59.
: 14. RIS Attachment  Section 2 of this document is titled regulatory clarification, but later in 2.2 it Delete or include in Section 4.
Page 3, Section seems to provide a framework for evaluating malfunctions of a different 2.2            result, I think this is better handled in Appendix D or is sufficiently covered in 96-07, since there is really no new guidance here, any attempt to provide it (which it seems you didnt in step #3), then I recommend this part be deleted. If the framework is deemed important include it in section 4.
: 15. RIS Attachment  With respect to the text including the statement:                                  Recommend one term be defined and used Page 3, 2nd    .the likelihood of common-cause failure (CCF) is much lower than              consistently throughout the document.
Paragraph      The term much lower is used several places in the document, as well as the term significantly lower.
: 16. RIS Attachment  With respect to the text including the statement:                                  This limitation also should be reflected the Page 3, 2nd    .reasonable assurance the likelihood of common-cause failure (CCF)..            RIS.
Paragraph      NEI 01-01 uses terminology similar to this and, by inference, is endorsed by RIS 2002-22. However, the applicability of the NEI guidance is limited to software failures (including common cause failures) and does not include other sources of CCF (such as hardware failures).
: 17. RIS Attachment  With respect to the text including the statement:                                  Clarify this section.
Page 3, 3rd    The above likelihood thresholds Paragraph      This conclusion in this section is acceptable, provided the applicability of the CCF statement of the 10CFR50.59(c)(2)(vi) threshold is limited to software failures. Otherwise the statement expands the scope of consideration CCF under 50.59 to well beyond the original RIS, NEI 96-07, the SRP, RG 1.70 and ANS/ANSI 51.1 & 52.1.
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Nuclear Energy Institute 1201 F Street N.W., Suite 1100 Washington, DC 20004
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                  Industry Comment                                          Recommended Change
: 18. RIS Attachment  With respect to the text including the statement:                              Please clarify meeting the above Page 3, 5th      For activities that introduce a potential failure mode (e.g., CCF) that does  thresholds Paragraph        not meet the above thresholds This section would be acceptable, assuming meeting the above thresholds means the likelihood of common-cause failure (CCF) is much lower than the likelihood of failures that are considered in the UFSAR (e.g., single failures) and comparable to other CCF that are not considered in the UFSAR. If not clarified, this statement expands the scope of consideration CCF under 50.59 to well beyond the original RIS, NEI 96-07, the SRP, RG 1.70 and ANS/ANSI 51.1 & 52.1.
Where CCF has been included in the licensing basis of the plants in the past, it has required a regulatory analysis and gone through rulemaking (e.g, ATWS and SBO). Such a regulatory analysis has not been performed for digital CCF.
The statement also is inconsistent with the SRM to SECY 93-087 and BTP-19 which state that CCF is beyond the design basis.
: 19. RIS Attachment / The following NOTE is stated, [Note: This likelihood threshold is not          Identify the Regulatory source of the Note or Page 3, Section  interchangeable with that for credible/not credible, which has a threshold  revise the Note to add sufficient clarity 2.1              of as likely as (i.e., not much lower than) malfunctions already assumed    (preferably with examples) to ensure it is not in the UFSAR.]                                                                mistranslated by the industry.
However, no basis for the note could be found in NEI 01-01 or NEI 96-07, Rev 1, or regulatory framework.
7


www.nei.org
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                          Recommended Change
: 20. RIS Attachment  With respect to the text including the statement:                              Add the following clarification/definition:
Page 4,Step 1 for the purpose of the 10 CFR 50.59 evaluation, credible Section        malfunctions..                                                                For the purposes of the technical evaluation, It is not clear that a credible malfunction considered in the technical        a CCF can be considered credible only if the evaluation is the same as a credible malfunction considered in the 50.59        likelihood of a CCF caused by an I&C failure process.                                                                        source is greater than the likelihood of a CCF caused by other failure sources that are not considered in a deterministic safety analysis described in the UFSAR.
: 21. RIS Attachment  Bullet nine - with respect to the text including the statement:                This need to be reworded to something that Page 4, Section malfunctions previously thought to be incredible.                            is bounding within the plant design basis.
2.2, Step 1    Step 1 in this process is to develop a list of possible malfunctions. Listing malfunctions that are previously thought to be incredible is not verifiable criteria and opens up the evaluation to any possible combination of failures (i.e., unrelated multiple failures).
: 22. RIS Attachment  2nd bullet, with respect to the text including the statement:                  Remove the statement including a single Page 4,Step 2 , there may be the potential marginal increase in likelihood of failure,      failure Section        including a single failure..
The statement identified in the bulleted item appears to be from NEI 01-01 Section 4.3.2. Where does the including a single failure wording come from?
8


P: 202.739.8053 M: 202.497.2051
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                  Industry Comment                                          Recommended Change
: 23. RIS Attachment  2nd bullet, with respect to the text including the statement:                  Please clarify the intent of the use of the Page 4, Section  For digital modifications, particularly those that introduce software        term software in this section based on the 2.2, Step 2      What is this intended to mean?                                                comment.
                          - Consider how digital modifications that do not involve software should be defined, as most digital equipment has software/firmware.
Examples are discrete logic chips and FPGAs.                            Please consider the use of the term
                          - Introduce software phrase could be taken that this only applies to        redundant and independent versus just the analog to digital mods. It should also address digital to digital mods  use of redundant.
                          - The use of redundant should also have independence stated. Please change to redundant and independent. This is a generic comment wherever redundancy is used. Independence is the key word.
Redundancy can be added in non-safety systems for reliability purposes only.
: 24. RIS Attachment  This statement, although out of NEI 01-01, would seem to imply that digital    Add supporting statement(s) that include Page 4,Step 2  upgrades will always increase the likelihood of failure, which has not been    acknowledgement of positive, not just Section          observed in actual practice where, in most cases, digital upgrades have        negative, impacts of installing digital been shown to decrease failure likelihood.                                    equipment.
Also, in 50.59 it is common practice to consider the balancing of positive effects of installing the digital equipment (e.g., elimination of SPVs, signal Further, rephrase the statements that imply validation, etc.) with the potential negative effects (e.g., SCCF, etc.) when  that digital systems will always increase the arriving at the final conclusion of not more than a minimal increase in        likelihood of failure to include the idea of no malfunction likelihood or accident frequency. The RIS does not appear to      more than a minimal increase text from discuss using the balancing effects of the positives and negatives of digital  50.59.
upgrades.
: 25. RIS Attachment / Bullets contain quoted guidance from NEI 01-01 and NEI 96-07, Rev 1;          Revise the last three bullets to ensure Page 4, Section  however, the quoted text from the last three bullets could not be traced back quoted information is accurate and traceable 2.2, Step 2      to either source.                                                              to the source document.
Provide a reference to the source.
9


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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                  Industry Comment                                          Recommended Change
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: 26. RIS Attachment    The title of this section is Draft Characteristics of Proposed Modifications  Clarify the applicability of the characteristics Page 5, Section 3 that Produce Effective Qualitative Assessments. The first paragraph of this   in this section to digital modifications.
3Sent through www.intermedia.com
section states:                                                                Consider changing Do not to:
[1] The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.
Do not create an adverse condition due The NRC staff finds that proposed digital I&C upgrades and modifications    to having all the characteristics listed below are more suitable to and effective for qualitative assessments and thus more likely to meet the 10 CFR 50.59 evaluation criteria.                                                          Remove that Produce Effective Qualitative Assessments from the title and delete more The title and wording in this section imply that the Qualitative Assessment    suitable to and effective for qualitative Framework is permitted only for digital modifications having all the          assessments and thus from the last characteristics in this section.                                              sentence of the first paragraph to avoid misinterpretation of this section.
Hearing Identifier:  NRR_DMPS Email Number:  185  Mail Envelope Properties  (41207040FCA6A84984074E806C73D73EE20B13) 
It is assumed that the term effective actually means produces positive results. The section reads more clearly without the word effective.
: 27. RIS Attachment    This sub-section states Digital I&C design function-for-design function      Unless the phrase design function-for-Page 5, Section 3 replacements and upgrades to systems and components that: Is the             design function provides additional criteria (1)              qualifier design function-for-design function both meaningful and           or meaning, it is suggested that it be removed.
necessary?
If the term provides specific meaning, please provide the criteria for determining the function for function alignment.
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==Subject:==
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                  Industry Comment                                          Recommended Change
[External_Sender] FW: NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)  Sent Date:  8/16/2017 4:05:06 PM  Received Date: 8/16/2017 4:05:32 PM From:    FREGONESE, Victor Created By:   vxf@nei.org Recipients:     "Morton, Wendell" <Wendell.Morton@nrc.gov>  Tracking Status: None "Rahn, David" <David.Rahn@nrc.gov>  Tracking Status: None
: 28. RIS Attachment    This section seems to constrain the digital modification to a very limited      Clarify the applicability and limitations of Page 5, Section 3 scope, which does not appear to meet the intent. For instance, it is not clear these constraints to address potential issues whether all of the attributes, or some of the constraints need to be met.      with items noted, such as:
Applying these in a strict way would eliminate most digital changes being        - DCS Upgrades contemplated, or currently being done. For example:                             - Safety Chillers
: a. 1a)-b) These conditions appear to only allow designs that dont        - Embedded Devices combine functions that were previously separate (this eliminates DCSs from being considered per this criteria, even if you use segmentation on separate controllers because they communicate via shared network, which is not acceptable).
: b. 2 could be construed to eliminate all safety systems that have two channels (chillers) from consideration since they will be digital and identical and this will screen them out before we even get a chance to demonstrate low likelihood of CCF.
: c. 3 is just a regurgitation of BTP 7-19 criteria, but the prelude to the section says that all criteria must be met, which is pretty much impossible for embedded devices.
: 29. RIS Attachment    The exclusion of systems using common HMI eliminates all non-safety            The type of systems that use shared Page 5, Section 3 related DCS upgrades from this RIS scope.                                       resources should be in scope of this RIS 1(a) & 1(b)                                                                                      which should describe that the licensee addresses combination of functions and spurious operation in the qualitative assessment.
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Post Office:  mbx023-e1-nj-2.exch023.domain.local Files    Size      Date & Time MESSAGE   4366      8/16/2017 4:05:32 PM 08-16-17_NRC_NEI 17-XX-Industry-Comments-NEI-Cover Letter.pdf   54333  08-16-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-General Comments_Attachment1.pdf   74548  08-16-17_NRC_NEI_17-xx-Consolidated Industry Comment-8-16-17-Editorial Comments_Attachment2.pdf    105134 08-17-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-Clarification Comments_Attachment3.pdf    206858 
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                            Recommended Change
: 30. RIS Attachment    With respect to the text including the statement:                              The RIS should clearly define the scope of Page 5, 1st      the qualitative assessment results alone are sufficient that software CCF    CCFs (software, etc.) being considered.
paragraph        does not need to be assumed The use of software CCF appears to limit the use of qualitative methods to demonstrate that CCF does not have to be assumed for other types of potential common cause failures.
: 31. RIS Attachment   With respect to the text including the statement:                             Clarify whether the different result is at the Page 5, Step 3                                                                                  SSC level or plant level. The industry position is that the results are evaluated at Only for possible malfunctions that do not have a sufficiently low likelihood the plant level, as discussed in the recent based on the qualitative assessment in Step 2, determine whether the          RIS public meeting.
malfunction has a different result.
: 32. RIS Attachment   With respect to the text including the statement:                              Remove implicitly assumed.
Page 5, 1(b)      Do not incorporate new shared resources..... implicitly assumed Implicit assumptions are impossible to verify. Should provide clarification on whether system function equals design function and if so, use design function.
: 33. RIS Attachment   With respect to the text including the statement:                              Please reword with reasonable assurance Page 6, Section 3 .that do not result in reduction of any aspects of independence            language instead of using do not.
(2)              This goes beyond reasonable assurance. Adding any software could and does result in a small quantitatively reduction.
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Options  Priority:    Standard  Return Notification:    No   Reply Requested:   No   Sensitivity:    Normal  Expiration Date:      Recipients Received:
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                          Recommended Change
JERUD E. HANSONSenior Project Manager,Life Extension & New Technology1201 F Street,NW, Suite 1100 Washington, DC 20004P: 202.739.8053 jeh@nei.orgnei.orgAugust 16, 2017Ms. Cindy BladeyMail Stop: TWFN-8 D 36M Office of Administration U.S.Nuclear Regulatory CommissionWashington, DC 20555-0001
: 34. RIS Attachment   With respect to the text including the statement:                             Eliminate the 100% testing criteria as the Page 6, item (3) as demonstrated through 100% testing                                      only test for simplicity.
There is a lack of clarity with industry (and perhaps regional inspectors) over what constitutes 100% testing, and this simplicity concept. Technical individuals working on the NEI/Industry DI&C teams have come to understand that any device containing software is not considered to be 100% testable, and we must assume a CCF.
If this is the case, then this RIS will only work for a very limited number of digital changes.
The 100% testing approach does not meet the qualitative intent of the RIS, and the reasonable assurance standard.
: 35. RIS Attachment  With respect to the text including the statement:                              Address the use of the term bounding with Page 6, item (3) bounded by previous FSAR analysis..                                         respect to plant level in this section, and further define FSAR analysis as safety analyses
: 36. RIS Attachment  With respect to the text including the statement:                             Add a discussion and clarify methods for Page 6, 4th      demonstration that the resulting replacement or upgrade design can            demonstrating what would be an acceptable paragraph        tolerate the postulated triggering of that defect                            way of tolerating the triggering of a defect.
This statement would seem to indicate that we must assume a design defect and then assume the design defect is triggered. If this is the intent, Clarify the statement to indicate whether a the RIS will likely not work for most safety related SSCs (including the      design defect must be assumed or not.
safety related chiller mod). If this is not the intent, should clarify the statement.                                                                    Define the basis for the design defect likelihood needing to be significantly lower.
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==Subject:==
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                            Recommended Change
NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22(Docket ID: NRC-2017-0154)
: 37. RIS Attachment  With respect to the text including the statement:                              Add a clear language in this paragraph that Page 6 last      Alternatively, electrical independence can be demonstrated qualitatively    states, software also can be addressed in a paragraph        The real purpose of this RIS is software and SCCF with respect to              qualitative manner and consider using a Page 7, first    independence.                                                                  digital example.
Project Number: 689
paragraph        Using electrical independence may not be the best example for this RIS.
: 38. RIS Attachment / A new term, layers of defense is used and is not defined. If this is intended Either define the term layers of defense or Page 7, Section  to refer to defense in depth, then defense in depth should be stated.      use the term defense in depth.
4.2 Alternatively, provide a reference to the USNRC or industry document being used to define layers of defense.
: 39. RIS Attachment  With respect to the paragraph beginning with:                                   Clarify this section to acknowledge a Page 8, Quality  For digital equipment incorporating software..                              different standard applies for non-safety Design Process  These attributes may not be available or well documented for non-safety        related upgrades.
related equipment that contains software. NEI 01-01 was primarily written to evaluate changes to safety related SSCs. Quoting this paragraph within the RIS may lead some (including regional inspectors) to believe that all these attributes must be accounted for when implementing a non-safety related digital upgrade with software involved.
: 40. RIS Attachment  With respect to the text including the statement:                              Please clarify the intent of this statement.
Page 8, Last    .thoroughly documented within the licensees quality assurance (QA) paragraph        program..
What is specifically meant by ... documented within the licensees QA program? Does this mean a formal qualitative assessment document must be developed and placed within the engineering change package for future retrieval?
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==DearMs. Bladey:==
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                  Industry Comment                                          Recommended Change
The Nuclear Energy Institute (NEI) 1and the industry appreciate the opportunity to provideintegratedindustry commentson theDraft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22.The purpose of this RIS is to clarify the NRC's endorsement of NEI 01-01 byproviding additionalguidance for preparing and documenting the "qualitative assessment" used to provide reasonable assurance that a digital modification will exhibit a low likelihood of failure, which is a key element in 10CFR50.59,"Changes, tests and experiments,"evaluations of whether the change requires prior NRC approval.This RIS supports our mutual interest in more efficient and effective licensing of digital upgrades across the operating fleet andwe look forward to issuance in the third quarter of 2017.Our principal comments are included below and more detailed comments are presented in the attachmentsfor consideration by the NRC staff.We appreciated the opportunity to participatein a public meeting to conduct a tabletop exercise utilizing the draft RIS 2002-22 Supplement for Digital I&C upgrades at nuclear power reactor facilities under 10 CFR 50.59on August 2, 2017. The draft RIS provided an effective framework for conducting digital upgrades within the scenarios that were demonstrated.  
: 41. RIS Attachment    In section 4.2 the last paragraph on page 8 says All of these categories      Please clarify intent of QA program Page 8, Last      should be addressed and thoroughly addressed in the licensees quality          reference.
paragraph        assurance program, in consideration of the safety significance of SSCs          Clarify QA program applicability is not based described below in Section 4.2 (See table 1) There may be confusion            on safety significance of SSCs, but on the about what this means.to be described in the QA program.                      licensees Quality Assurance Program.
: 42. RIS Attachment    Please add endorsed EPRI TR-106439 as an acceptable example for digital Please add the reference as noted.
Page 8            commercial grade dedication mods.
Page 9, Table 1
: 43. RIS Attachment    For Table 1, the list of acceptable examples, is this list intended to be      Please clarify the applicability of the Table 1          addressed by each evaluation, or is this just a suggested list? For the        examples cited in Table 1, and their design attributes, what is the expectation on behalf of the NRC that there be intended use.
all items, or some items? Is the determination of adequacy up to the licensee or will this list constitute the basis for a Mods or 50.59 inspection?
: 44. RIS Attachment /  Environmental Qualification implies a Regulatory programmatic                Revise environmental qualification to Page 9, Table 1  requirement; however, based on the subsequent examples, (e.g., EMI/RFI,        demonstrated tolerance (e.g., through Seismic), this does not appear to be the context.                             qualification testing) to withstand environmental conditions within which the SSC is required to perform its design function (e.g., EMI/RFI, Seismic).
: 45. RIS Attachment    Watchdog Timers - The RIS should not limit credit for external watchdog        Suggest changing to Watchdog timers that Table 1          timers only. There are designs that have internal watchdog timers that          operate independent of software or Design Attributes operate independent of the software and are considered just a reliable as      something to that effect.
external watchdog timers (the digital reference adjuster used on the EDG voltage regulator project is an example of an independent internal watchdog    An acceptable alternative might be timer).                                                                        Watchdog timers that time out in hardware..
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1The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                          Recommended Change
Ms. BladeyAugust 16, 2017 Page 2Application to safety-related systemsThe scope of the RIS and attachment should be clearly stated as intended to be used for safety-related systems only. It should be clear that the RIS could, or might be used as guidance for non-safety related upgrades only if desiredby licensees.Therefore, industry requests that the RIS should provide sufficient clarity to avoid an interpretation that it is viewed as "mandatory" for non-safety related systems.Comment
: 46. RIS Attachment    Sufficiently simple and 100% testing are used here.                       See previous comments on this subject.
Table 1                                                                                        Suggest acknowledging other types of Design Attributes                                                                              testing to demonstrate the design is sufficiently simple, such as comprehensive, or exhaustive testing, versus just 100%
testing.
: 47. RIS Attachment    Failure state always know to be Safe - An acceptable failure state could    Revise to describe that the failure state of Table 1          also simply be equivalent to the failure state of the device being replaced, the new digital equipment can be the same Design Attributes not necessarily to the safe state.                                          as the failure state of the existing equipment (whether or not the failure state is considered safe).
: 48. RIS Attachment    The last bullet indicates that high volume commercial products are less      Augment the discussion to suggest that Table 1          likely to have deficiencies.                                                High volume, high quality commercial Operating                                                                                      products with applicable operating history Experience                                                                                    used in other applications have the potential to not include as many design errors.
: 49. RIS Attachment    This paragraph does not clearly distinguish between safety related and non-  Please clarify applicable scope for digital Page 10, 4.2.1.1  safety related SSCs. Digital communications (ISG-04) is a concern primarily  communications criteria, to clearly specify with Safety Systems and is not applicable to non-safety systems. Though      that ISG-04 is applicable to only safety there is very good guidance in ISG-04, this section seems to make it        related modifications.
required to be addressed for all classes of systems that might be evaluated by this process. Would digital communication between non-safety SSCs        Please clarify to address how this might be considered out-of-scope of this RIS? For example, a plant may have two      applied to non-safety related examples.
(redundant) feedwater pumps - not for plant safety but for operational convenience. Would digital communication between the two feedwater          Also, while ISG-04 is good guidance, and pump controllers be out-of-scope for this RIS?                              has been in place for more than a decade, it would be preferable to refer to more durable guidance.
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#1 within attachment #1, provides suggestionsto address this point.Impact on digital system common cause failureThe draft RIS is characterized as a means to allow for low risk (non-protection systems) changes to safety systems to go forward under50.59, butthere is no discussionof risk considerations. Instead,it includesarecommended level of rigor for the engineering evaluations needed to support the 50.59 process without providing any assurance that these will be accepted for "low risk" systems.These "low risk" systems have been incorrectly includedinthe current NRC staffposition on common cause failure (CCF)policy,due to changes over time to Branch Technical Position (BTP)7-19. It should be clearly stated how the RIS impacts the current NRC policy/position that addressesdigital system CCF.Comment #2within attachment #1, provides suggestionsto address this point.Application to non-power reactorsThis RIS should be applicable to include non-power reactors(NPRs).Relevant guidance contained within NEI 96-07 and RG 1.187 isapplicable to NPRs, and digital upgrades at NPRs should be addressed within thisRIS.Comment #3 within attachment #1,provides suggestions to address this point.We appreciate the opportunity to comment on the DraftRIS.If you have any questions or require additional information, please contact me.
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                               Industry Comment                                            Recommended Change
Sincerely, Jerud E. Hanson Attachments c:John W. Lubinski, NRR, DEc:Jason Drake, NRR, DE Comment No.Section/Page #Industry CommentRecommended Change1.GeneralThe scope of the RIS and attachment needs to be limited to safety-related systems only. It should be very clear that the RIS could, or might be used as guidance for non-safety related upgrades if desired.The RIS should provide sufficient clarity to avoid an interpretation that it is to be viewed as "mandatory" for non-safety related systems.Clearly state the applicability of the RIS and attachment is intended to be used for safety related systems only.2.GeneralThe Draft RIS was characterized as a means to allow for low risk (non protection systems) changes to safety systems to go forward in 50.59, but there is no mention of any sort of risk considerations in the Draft RIS. Instead it mainly provides a recommended level of rigor for the engineering evaluations needed to support the 50.59 without providing any assurance that these will be accepted for "low risk" systemsthat have been incorrectly pulled into the CCF policy due tochanges to BTP 7-19.Nowhere in this RIS is astatement on scope of the policy on CCF,in fact it seems to reinforce the current content ofBTP 7-19 into not only safety related components but non safety components that are in the licensee design basis.Describehow the RIS impacts the current NRC policy/position documentsthat address digital system CCF, such that end users of the RIS are clear how, or if, other NRC CCF policy/position documents apply to the activities within the scope of the RIS.
: 50. RIS Attachment    For section 4.2.1.2 the gist of this section is that combination is bad in all Revise to acknowledge cases where Page 10, 4.2.1.2  cases, however, there are cases where combination of previously separate      combination of functions may result in a components results in a more dependable system due to the tightly coupled      more reliable and safer system.
Comment No.Section/Page #Industry CommentRecommended Change3.GeneralThe non-power reactor community was not included in consideration of this RIS.At the May 25, 2017 public meeting on this proposed RIS there was discussion of the importance of including non-power reactor licensees within this proposed RIS.The general consensus was that non-power reactors should be included within its scope.It appears that the exclusion of non-power reactors from RIS 2002-22 was likely an oversight. EPRI TR-102348 and Generic Letter 95-02 are referenced in NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, for use by the non-power NRC staff and licensees in licensing DI&C upgrades.Though they followed after the issuance of NUREG-1537, the revision to EPRI TR-102348 (NEI 01-01) and related RIS 2002-22 are also used by the non-power NRC staff and licensees in licensing DI&C upgrades.NEI 96-07 and associated RG 1.187 are also applicable to non-power reactor licensees.Please include non-power reactors within the scope of the RIS.4.GeneralThe RIS does not specify whether the NRC expectation is that the Qualitative Assessment guidance is to be used for 50.59 screening.Add a statement that the RIS is intended to be used for 50.59 evaluations, but may be consulted during the 50.59 screening process.
nature and a reduction in complexity. A good example is the combination of Main Feed regulating valves with Feed bypass valves into one controller, this has allowed the industry to use one controller to control steam generator level through all power levels, where previously there was a manual cross over at a low power that often resulted in spurious level changes and plant trips due to loss of level control, those types of plant upsets are much less frequent with a combined system where both valves are controlled by one controller. A plant transient from both a bypass and MFRV may not be evaluated in the License but if the overall result from combining the two is a marked increase in dependability, in the aggregate.
Comment No.Section/Page #Industry CommentRecommended Change1.Draft RIS Page 1"Intent" ParagraphIn the ninth line of this paragraph, please augment the implicit statement of applicability to ensure that the reader recognizes that RIS 2002-22 is being supplemented rather than supplanted. The text does not make this extremely clear and unambiguous.Replace "- this RIS is to clarify the NRC's endorsement of NEI 01-01-" with "- this supplemental RIS clarifies still-active RIS 2002-22 that endorsed NEI 01-01-"2.Draft RIS Page 2Section titled "Background Information"Background Information section, first full paragraph, Correct the title of NEI 96-07, Evaluationsshould be Implementation.Correct text as noted.3.Draft RIS Page 3 Section titled "Summary of Issue" SectionAt the end of the last sentence inthe paragraph starting "Specifically, this RIS-" add words that clarify that the problem is in software.Revise from"- methods to demonstrate the likelihood of failure" To"-.methods to demonstrate the likelihood of failure" from software design errors"4.Draft RIS Page 4 Section titled "Clarification of Guidance for Addressing Digital I&C Changes under 10 CFR 50.59"For readability, please consider bolding these italicized section headers to make them stand out in the rest of the text.Use bold text for section headers.
: 51. RIS Attachment    With respect to the discussion on combination of functions:                    Please add language that allows Page 10, 4.2.1.2, This section should acknowledge that combination of functions is allowable    combination of functions where it does not 3rd sentence     where it does not create an adverse condition; the 3rd sentence does not       create an adverse condition.
Comment No.Section/Page #Industry CommentRecommended Change5.Draft RIS Page 4 Section titled "Clarification of Guidance for Addressing Digital I&C Changesunder 10 CFR 50.59"In the second full paragraph, second line, the word "appropriate" is ambiguous.The last sentence in this paragraph isvery long.Replace "appropriate" with something more like "applicable"Split the last sentence into "- applied to the proposed design. Using such standards-"6.Draft RIS Page 4 Section titled "Clarification of Guidance for Addressing Digital I&C Changesunder 10 CFR 50.59"In the paragraph starting "To assist licensees", the second line, the sentence should be simplified.Replace "- the NRC staff has clarified within the attachment to this RIS its position-" with "- the attachment to this RIS clarifies the NRC staff position-"In the last sentence of this paragraph, delete "clarification within the" as "- the attachment describes-" is sufficient.7.Draft RIS Page 4 Section titled "Clarification of Guidance for Addressing Digital I&C Changesunder 10 CFR 50.59"In the next to last line of the first paragraph, it is not clear what "alter the conclusions of" means to a licensee.Replace "alter the conclusions of by the safety analysis" with "alter the conclusions of or not be bounded by the safety analysis in the UFSAR" Comment No.Section/Page #Industry CommentRecommended Change8.Draft RIS Page 4 Section titled "Backfitting and Issue Finality Discussion"In the first paragraph, please reiterate that this RIS supplements, but does not supersede, RIS 2002-22.In the second paragraph, the first sentence does not define on whom the guidance might be imposed.Replace "- supplements RIS 2002-22-" with "- supplements but does not supersede RIS 2022-22-"Rework the first sentence in the second paragraph.9.RIS Attachment, page 1, "Purpose"The first paragraph, first sentenceis excessively long, with the result of being difficult to read and understand.Replace "- 10 CFR 50.59 Rule," for use as guidance for implementing-" with "- 10 CFR 50.59 Rule." This RIS provides guidance for implementing-"10.RIS Attachment, page1, "Purpose"In the second paragraph, reinforce that this is a supplemental RIS.Change "- to provide clarifying guidance-" with "- to provide supplemental clarifying guidance-"Change "Following this guidance will help-" with "Following the guidance in the RIS 2022-22 and NEI 01-01, as augmented by the guidance in this RIS-"11.RIS Attachment, page 1, "Likelihood Justifications"This second would be easier to find if it were set in bold type.Change the format to bold on all section headers throughout the attachment, including those that are underlined.12.RIS Attachment Page 2, "Regulatory Clarification-"In the first paragraph, last sentence, there are extra words, and a missing reference to where the characteristics that should be evaluated are defined.Delete both "that" in the sentence, and replace "there are some important" with "several important". Provide some reference, even within the RIS, to the "important characteristics" that we should evaluate.
accurately reflect verbiage consistent with 10 CFR 50.59.
Comment No.Section/Page #Industry CommentRecommended Change13.RIS Attachment Page 3In the paragraph starting"10 CFR 50.59 (c)(2)(vi)" in the fourth line, "that" is missing.Replace "- reasonable assurance the likelihood-" with ""- reasonable assurance that the likelihood-"14.RIS Attachment Page 4, Section
: 52. RIS Attachment /  The phrase the other NRC-approved processes does not provide                 If the other NRC-approved processes is Page 10, 4.2.1.2, guidance.                                                                     intended to be license amendment request, last sentence                                                                                   so state. Else, define all the other processes that could be followed.
: 53. RIS Attachment    This section should include reference of EPRI TR-106439 as an acceptable      Add the noted reference.
Page 10, 4.2.2    example for digital commercial grade dedication mods.
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2.2, Step 1Bullets contain quoted guidance from NEI 01-01 and NEI 96-07, Rev 1; however, in a couple cases, the quoted information is not correct. Revise bullets 1 and 3 to ensure the quoted text is accurate and traceable to the source
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                Industry Comment                                          Recommended Change
: 54. RIS Attachment  There is no expanded discussion on the Operating Experience topic.            Revise document to use Section 4.2.3 as an Page 11        Sections 4.2.1 and 4.2.2 expand on the other bullet points noted on Page    expanded discussion on Operating 7 and Page 8 of the attachment (Design Attributes and Quality Design          Experience. Move current Section 4.2.3 Process).                                                                    content to another section of the document.
: 55. RIS Attachment  Quality Standards - please clarify the use of the term quality standards in Clarify the use of the term quality Page 11, 1st    the RIS. If the intent is to define a high quality design process, then the  standards.
paragraph      licensee Appendix B program should govern the activities as applicable.
It should be noted that there is no requirement for mandatory use of any other type of quality standard for non-safety related applications.
: 56. RIS Attachment  It appears that the YES/NO labels should be reversed on the diamond near      Flip the YES / NO labels.
Figure 1        the top of the page which states Does the proposed change have the characteristics described in the attachment to the RIS?                      Suggest being more specific by adding a Also, the first box appears to be selecting criteria. That is, if the        specific section number of the RIS that characteristics dont match (e.g. no combinations, no communications, etc.)  details the characteristics. (RIS Section 3?)
they you cant use this process. If you exit the RIS 2017-xx process, then are on your own to use NEI 01-01 as originally endorsed in RIS 2002-22?      Consider an exit to this process that shows the previous RIS/NEI 01-01 process.
: 57. RIS Attachment  The flowchart only addresses 50.59 Evaluations Questions 2 and 6.            Suggest addressing Questions 1 and 5.
Figure 1        Questions 1 and 5 do not appear to be addressed in the flowchart.
: 58. RIS Attachment  Conduct the Technical Analysis and Assess Vulnerabilities is split into two  Provide explanation as to why this process Figure 1        boxes, but in reality the vulnerabilities will be assessed in the design      is split into 2 boxes, and/or update Figure 1.
change (in the box that feed into the Conduct Technical Analysis). Is this split into two boxes because the RIS expect two distinct documents? Or do both of the boxes constitute the single Qualitative assessment as outlined in Table 2. The assumption is that it is broken out based on some thought model held by the staff, but in actuality this is all done under the design change process and is only documented in the 50.59 as a high level summary with sufficient detail to assist the approver of the 50.59 (and to support the NRC review under Mods inspections).
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document.15.RIS Attachment Page 7, last paragraphDelete the entire paragraph beginning with:  "Documentation is needed-..Replace with the following:"Documentation is needed to demonstrate the proposed design will not create malfunctions with different results or initiate a different type of accident not previously analyzed in the UFSAR. Within the concept of layers of defense, acceptable justification for concluding an accident of a different type will not be initiated to include the postulated new accident is only possible after asequence of multiple unlikely independent failures. This type of justification should also be documented as part of the qualitative assessment."16.RIS Attachment Page 8In the last line, a reference to the major section we are in is not helpful.Either revise "Section 4.2" to be more useful, or remove the reference to a general section in the RIS Attachment.17.RIS Attachment Page 8,"Operating Experience"In the second paragraph, the subject (software and hardware) is plural. In the last sentence, the phrase "along with consideration of the supplier of such equipment" should be set off in leading and trailing commas.Replace "-modification has-" with "- modification have-"Add commas before and after the phrase.
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                               Industry Comment                                          Recommended Change
Comment No.Section/Page #Industry CommentRecommended Change18.RIS Attachment Page 9, 4.2.1 2 n dparagraph.Revise the following from:
: 59. RIS Attachment   This section appears to be written for safety-related software. In most      Update this section to reflect the level of Page 13, Section cases, the evidence required in Section 5.1 would be difficult to compile for documentation that might be typically seen 5.1             non-safety software containing COTS devices.                                 for non-safety related upgrades.
"-.do not result in a potential-.
Augment the software safety analysis to software safety analysis (as applicable) to capture the non-safety related equipment.
To:"-do not result in more than minimal-"19.RIS Attachment Page 9, 4.2.1In the first paragraph, last sentence, it might be clearer if the three steps in the justification were numbered(e.g., "1) a thorough description of the -, 2)the design attributes..., and 3) a clear description-"Further,it is not clear how extensive"thorough" is expected to be.Please consider clarification of this paragraph. Delete "thorough."20.RIS Attachment Page 10, 4.2.1.2Sentence beginning with "If the qualitative assessment-..Revise the following from:..a new type of accident, a malfunction with a new result, or an unbounded malfunction or accident now exists due to the combing of functions creating new malfunctions, or new inter-system interactions, etc, then-..
: 60. RIS Attachment   In Section 5.1 there is a statement that says that the Qualitative            Revise document to address the software Page 13, Section Assessment should provide evidence that a well-defined process for - and      process typically seen for non-safety related 5.1              it continues on with a statement of components from BTP 7-14, which again and commercially dedicated equipment.
To:-a new type of accident or, a malfunction with a different result now existsdue to the combination of functions, then-.21.RIS Attachment Page 10First paragraph.Revise the following from:-.the potential for new malfunctions or accidents should be evaluated-.
is only applicable to safety-related software and would also be germane (but not required) for non-safety related software. What if any concessions are allowed for those non-safety and even those components that are Commercially dedicated where we will often credit extensive operating history and testing along with largely equivalent software processes, where portions of the software lifecycle are less relevant and not needed to make the Qualitative Assessment for less risk significant system that screen into 50.59 evaluation? See comment below on section 5.2 19


To:-the potential for malfunctions with a different result or accidents of a different type should be evaluated--
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                                 Industry Comment                                            Recommended Change
Comment No.Section/Page #Industry CommentRecommended Change22.RIS Attachment Page 11, 1 stparagraphThe first sentence is too long.Replace "- development organization that provides for common and repeated use, rules-" with "- development organization. These quality standards provide rules-" and move "for common and repeated use" to the end of the sentence, replacing"context" with "context, for common and repeated use."23.RIS Attachment Page 11, 4.2.3In the last sentence of the first paragraph, there are extraneous words and an imprecise set of references.In the last sentence of the first paragraph, delete "other avenues for performing the change, i.e., " and list all avenues.24.RIS Attachment Page 11, 4.2.3In the first sentence of the last paragraph, there are extraneous words.Replace "- guidance provides the kind of process that should be engagedwhen using this guidance" with ".. guidance illustrates the process to use this guidance."25.RIS Attachment Figure 1The diamond near the top of the page states "Does the proposed change have the characteristics described in the attachment to the RIS?". It is suggested that the "characteristics" being reference be pointed out specifically in the RIS attachment. Change the phrase to state "Does the proposed change have the characteristics described in RIS attachment section 3?"26.RIS Attachment Figure 1The second decision block language is not consistent with the verbiage used in 10 CFR 50.59.Revised the second decision block question verbiage to align with 10 CFR 50.59.
: 61. RIS Attachment   In Section 5.2 there appears to be a hint of grading by safety significance,     Please clarify basis and applicability of Page 13, Section which is in keeping with the original NEI 01-01, but the two lists are not well  these grading criteria.
Comment No.Section/Page #Industry CommentRecommended Change27.RIS Attachment Table 2Step 1.Revise wording from:"What are all of the UFSAR design functions.."
5.2              defined, are you saying that the items on the list constitute a risk significant system? Are they in any order of risk significance, or are they all considered equally risk significant? With the contrary being deemed less risk significant and therefore less documentation required and the second list seems to have a function based criteria. Same question as above, (all risk significant; any sort of hierarchy implied?). Will this grading be up to the utility? Or will this RIS address which would be acceptable?
To:"What are all of the UFSAR described design functions"Alternatively, "What are all of the design functions described in the UFSAR"28.RIS Attachment Table 2 Step 4, 2 n dbullet.Revise wording from:"The digital components' likelihood of postulated CCF likelihood
: 62. RIS Attachment   2nd bullet - With respect to the term accident mitigation system              Suggest clarifying by stating ... accident Page 13, Section Is this statement referring to accident mitigation systems that are credited in  mitigation system credited in the safety 5.2             the safety (or accident) analysis? There are some non-safety systems that       analysis.
can be used for accident mitigation but are not credited in the safety (accident) analysis (e.g., off-site power is the preferred source of power for mitigating accidents but is not generally credited as an accident mitigator in the safety (accident) analysis). There is some confusion in the industry when it comes to defining a SSCs that are considered accident mitigators.
: 63. RIS Attachment  With respect to the following statement:                                        Request this section be clarified to Page 14, last    It is the responsibility of the licensees 10 CFR 50.59 evaluator to           differentiate between where design basis paragraph        demonstrate that the documentation of the design basis                        information is documented (for instance, the plant modification process), versus where licensing basis information is documented (for instance in the 50.59 evaluation).
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To:"The digital components' postulated CCF likelihood"29.RIS Attachment Table 2Step 3.Revise wording from:"Could those potential impacts already be bounded by the results of the design basis analyses, or would the analyses need to be revised to address it?"
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                               Industry Comment                                              Recommended Change
To:"Are potential impacts already bounded by results previously evaluated in the UFSAR or would the safety analyses need to be revised to address potential impacts?"
: 64. RIS Attachment  Step 1, last bullet:                                                           Add clarification as described in comment.
Comment No.Section/Page #Industry CommentRecommended Change1.ALLThe DRAFT RIS uses the term, "qualitative assessment" more than 15 times throughout the RIS.In the context where it is used, in most case, either an implicit or explicit definition is stated.This is confusing.Also, in a few random cases "effective qualitative assessment" is used.This DRAFT RIS does not define the differences between the two.Overall, "effective qualitative assessment" seems out of place because either the conclusions of a qualitative assessment support the outcomes when used in a 10 CFR 50.59 Review or they do notDefine the term "qualitative assessment" once, then only use the term in the balance of the text.Suggest using a definition that states that the purpose of the qualitative assessmentisto demonstrate reasonable assurance of adequate quality and low likelihood of failure through a review of the system design process and design features.This would be consistent the with NEI 01-01 discussion of dependability (page 5-14).For clarity and to avoid confusion, remove the word "effective" from "effective qualitative assessment" throughout the text.
Table 2         Please add clarification that the evaluation should consider both active and inactive states.
Comment No.Section/Page #Industry CommentRecommended Change2.ALLThe terms 'safety significance' and 'safety significant' are used throughout this section without formal definitions.
: 65. RIS Attachment  Step 1, 3rd bullet - Safety and power generation functions.                     Please clarify what this statement is asking Table 2                                                                                        for, it is not entirely clear.
It is noted that use of these terms is limited to defining the level of documentation that is worthwhile and is not used as input to answering the 50.59 questions.The scope of the draft RIS is such that the definition of 'safety significant' is not consistent with its use in other regulatory applications The term 'safety significant' as used in regulatory applications today generally has a definition that is much broader than just the licensing basis for the plant and often includes risk-insights (e.g., see the definition of safety significant in 10CFR50.69).Throughout the Qualitative Assessment Framework, review of the modification under 50.59 is restricted to the plant design basis as documented in the UFSAR.As the Qualitative Assessment Framework clearly is limited to the licensing basis for the plant and is neither risk-informed nor considers risk insights, the term 'safety significant' should be avoided and replaced with a regulatory term having a formal definition applicable to the scope of this guidance, 'important to safety' (as definedin the UFSAR).Suggest using 'important to safety as defined in the UFSAR' as it has a formal regulatory definition associated with the design basis.3.Draft RIS Page 1"Intent" ParagraphThe term "reasonable assurance" is used here and in footnote 1.Nobasis is provided for use of a different standard as used in the RIS, versus the broader regulatory standard.What is the source for the footnote?Having different definitions of this term will cause confusion.As an example, the RIS uses the term "reasonable assurance" nearly 20 times throughout the documentin various contexts.In many cases, the RIS includes quotes from NEI 01-01 with this term included.Remove the footnote, or, further define the term "adequate degree of certainty."Identify the Regulatory sources of the footnote that clearly definesthe difference between "adequate degree of certainty" and "broader NRC regulatory standard".
: 66. RIS Attachment Step 3 - Enhanced Safety Analysis.                                             Please define or clarify what enhanced is Table 2                                                                                        referring to.
Comment No.Section/Page #Industry CommentRecommended Change4.Draft RIS Page 2Section titled "Background Information"In the third full paragraph, fifth line, reinforce the idea that this supplement is to be used with RIS 2002-22.Replace "This RIS supplements the NRC Staff's previous endorsement of the NEI 01-01 guidance-" with "This RIS supplements the still-active RIS 2002-22 endorsement of NEI 01-01 guidance-" At the end of the paragraph, explain that this RIS is expected to provide the additional detail necessary to ensure resolution of the issues that have occurred when applying RIS 2002-22 and NEI 01-01.5.Draft RIS Page 2Section titled "Background Information"In the last full paragraph on this page, IAP MP #1 is mentioned in the context of 50.59.Explainhow the CCF portion of the modernization plan interacts with the 50.59 evaluation in the RIS discussion.6.Draft RIS Page 3"Summary of Issue" SectionWith respect to the text including the statement:"there may be a potential for a marginal increase in the likelihood of malfunctions "Although this statement paraphrases NEI 01-01, Section 4.3.2, it seems to imply that digital upgrades will always result in a marginal increase in malfunction likelihood. In practice, industry has observed the opposite -that digital upgrades tend to decrease malfunction likelihood as most digital upgrades eliminate single points of vulnerability, provide for signal validation, afford internal diagnostics and alarming capabilities -to name just a few characteristics that go beyond the capabilities of their analog counterparts.This sentence may cause confusion within industry and with regional inspectors if it is interpretedto mean that digital upgrades are expected to increase malfunction likelihood.Clarify this statement to be clear that digital upgrades are notalways expected to increase malfunction likelihood.Rephrase to use the "no more than minimal increase" text from 50.59.
: 67. RIS Attachment Step 3 - Failure Modes.                                                         Please add a note stating that the failure Table 2                                                                                        mechanisms can change. Please add a note allowing us to eliminate failure modes of the original equipment in the replacement equipment.
Comment No.Section/Page #Industry CommentRecommended Change7.Draft RIS Page 3Section titled"Summary of Issue" SectionThe sentence leading into the last paragraph on the page:The RIS pulls out a statement from RIS 2002-22 and states that the Draft RIS does not change NRC staff position, which apparently is that NEI 01-01provides an acceptable means.This seems to be at odds with the statements in the final two paragraphs of this section that the appendix will provide content, rationale and evaluating factors to be addressed, along with a shortlist of design attributes primarily drawn from the existing BTP 7-14.Please clarify whether there is a change in NRC staff position from what was previously endorsed in NEI 01-01.8.Draft RISPage 4, Section titled "Clarification of Guidance for Addressing Digital I&C Changesunder 10 CFR 50.59"With respect to the text including the statement: "ensuring that the uncertainty of qualitative assessments is sufficiently low" What is meant by this statement?Generally speaking, the qualitative assessment is used to draw the conclusion that the digital change has a low likelihood of failure.Suggest deleting this portion of the sentence as it may cause confusion.9.RIS Attachment / Pages 1-17The attachment seems to explicitly specify a quality process, structure and format for the qualitative assessment that if left without clarification, could result in a significant impact on the industry in the areas of procedures, qualification, and training, if the interpretation is that the qualitative assessment attributes are viewed as mandatory.In the "Purpose" section of the Attachment, It should be made clear that the format, content, and structure of the Attachment is an example of what an acceptable Qualitative Assessment could contain, and that the implementation details are up to the licensee.
: 68. RIS Attachment Step 4 - last paragraph, beginning with All assertions                      If this is the case, please explain. If this is Table 2         This statement implies that the licensee must assume a CCF.                     not the case, please reword or provide clarification.
Comment No.Section/Page #Industry CommentRecommended Change10.RIS Attachment / Pages 1-17Outcomes from a qualitative assessment that would in turn be used as engineering/technical information in a 10 CFR 50.59 review are specified as "finds", "final determination", "resulting", etc.This inconsistent verbiage is confusing.
: 69. RIS Attachment In Table 2: Steps 4 and 6 seem to be repeats, you make the assertions and       Leave one or the other out, the evidence Table 2         provide the evidence, then repeat the assertions.                               needs to support the assertions either way.
Examples of this are:Section 2.1, last paragraphPage 2 of 17, 3 rdparagraph Section 3, 1 stparagraphRecommend that the outcome of a qualitative assessment be described as "conclusions" because conclusions are the translation of the results.Therefore, the conclusions of an assessment are the engineering/technical information that is important to the 10 CFR 50.59 review. 11.RIS Attachment Page 2, 1st ParagraphIn section 2.1 (likelihood justifications) the attachment discusses the link between dependability and likelihood of failures, but in the next to the last paragraph, there seems to be an interchangeable use of reliability and dependability, recommend sticking to dependability.Furthermore, the inclusion of "reliability" in the next to the last paragraph in this section is a miss-representation of NEI 01-01 which makes this point that for some high risk systems, there may be a need to provide additional assurance of adequate defense in depth and diversity.Since there is no mention of this, in the section, it can only be implied that all changes, without regard to risk will require a demonstration of defense in depth, but some systems do not require defense in depth becausethere is no requirement to do D3, but this could be construed to put that requirement onto the licensee.Recommend reconciling the use of "reliability" versus "dependability" in the documents.12.RIS Attachment Page 2, 3 rd ParagraphThis section discusses a reasonable assurance standard for evaluating low likelihood of failure.It's important to note that the new digital equipment must only be as reliable/dependable as the equipment it is replacing. The likelihood of failure is relative to the equipment being replaced. Revise section to include a statement that captures the following concept:The new digital equipment is not held to a higher standard than the analog (or even digital) equipment it is replacing.
If not repeats, but rather two steps in a process, where identification is done Clarify why the two steps are provided.
Comment No.Section/Page #Industry CommentRecommended Change13.RIS Attachment Page 2, 7th ParagraphWith respect to the text including the statement:"(whether or not classified as safety-related in accordance with 10CFRPart 50, Appendix B)"Remove this statement from the paragraph, and if still necessary, place it elsewhere in the text, in a context that is not tied to 50.59.14.RIS AttachmentPage 3, Section 2.2Section 2 of this document is titled regulatory clarification, but later in 2.2 it seems to provide a framework for evaluating malfunctions of a different result, I think this is better handled in Appendix D or is sufficiently covered in 96-07, since there is really no new guidance here, any attempt to provide it (which it seems you didn't in step #3), then I recommend this part be deleted.If the framework is deemed important include it in section 4.Delete or include in Section 4.15.RIS Attachment Page 3, 2 nd ParagraphWith respect to the text including the statement:"-.the likelihood of common-cause failure (CCF) is muchlower than-"The term "much lower" is used several places in the document, as well as the term "significantly lower".Recommend one term be defined and used consistently throughout the document.16.RIS Attachment Page 3, 2 nd ParagraphWith respect to the text including the statement:"-.reasonable assurance the likelihood of common-cause failure (CCF).."NEI 01-01 uses terminology similar to this and, by inference, is endorsed by RIS 2002-22.However, the applicability of the NEI guidance is limited to software failures (including common cause failures) and does not include other sources of CCF (such as hardware failures).This limitation also should bereflected the RIS.17.RIS Attachment Page 3, 3 rd ParagraphWith respect to the text including the statement:"The above likelihood thresholds--"This conclusion in this section is acceptable, provided the applicability of the CCF statement of the 10CFR50.59(c)(2)(vi) threshold is limited to software failures.Otherwise the statement expands the scope of consideration CCF under 50.59 to well beyond the original RIS, NEI 96-07, the SRP, RG 1.70 and ANS/ANSI 51.1 & 52.1.
in one step, and verification of resolution is provided in a separate process, then suggest clarification.
Clarify this section.
: 70. RIS Attachment  Step 5, 2nd paragraph, vectors to malfunctions.                               If definition exists, please provide it; Table 2                                                                                        otherwise recommend deletion.
Comment No.Section/Page #Industry CommentRecommended Change18.RIS Attachment Page 3, 5th ParagraphWith respect to the text including the statement:"For activities that introduce a potential failure mode (e.g., CCF) that does not meet the above thresholds-"This section would be acceptable, assuming 'meeting the above thresholds' means the likelihood of common-cause failure (CCF) is much lower than the likelihood of failures that are considered in the UFSAR (e.g., single failures) and comparable to other CCF that are not considered in the UFSAR.If not clarified, this statement expands the scope of consideration CCF under 50.59 to well beyond the original RIS, NEI 96-07, the SRP, RG 1.70 and ANS/ANSI 51.1 & 52.1.Where CCF has been included in the licensing basis of the plants in the past, it has required a regulatory analysis and gone through rulemaking (e.g, ATWS and SBO).Such a regulatory analysis has not been performed for digital CCF.The statement also is inconsistent with the SRM to SECY 93-087 and BTP-19 which state that CCF is beyond the design basis.Please clarify -"meeting the above thresholds"19.RIS Attachment / Page 3, Section 2.1The following NOTE is stated, "[Note: This likelihood threshold is not interchangeable with that for "credible"/"not credible," which has a threshold of "as likely as" (i.e., not "much lower than") malfunctions already assumed in the UFSAR.]"However, no basis for the note could be found in NEI 01-01 or NEI 96-07, Rev 1, or regulatory framework.Identify the Regulatory source of the Noteor revise theNoteto add sufficient clarity (preferably with examples) to ensure it is not mistranslated by the industry.
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Comment No.Section/Page #Industry CommentRecommended Change20.RIS AttachmentPage 4,"Step 1" SectionWith respect to the text including the statement:
"-for the purpose of the 10 CFR 50.59 evaluation, "credible" malfunctions.."It is not clear that a credible malfunction considered in the technical evaluation is the same as a credible malfunction considered in the 50.59 process.Add the following clarification/definition:For the purposes of the technical evaluation, a CCF can be considered credible only if the likelihood of a CCF caused by an I&C failure source is greater than the likelihood of a CCF caused by other failure sources that are not considered in a deterministic safety analysis described inthe UFSAR.21.RIS Attachment Page 4, Section 2.2, Step 1Bullet nine -with respect to the text including the statement:"malfunctions previously thought to be incredible."Step 1 in this process is to develop a list of "possible" malfunctions.Listing malfunctions that are previously thought to be "incredible" is not verifiable criteria and opens up the evaluation to any possible combination of failures (i.e., unrelated multiple failures). This need to be reworded to something that is bounding within the plant design basis.22.RIS AttachmentPage 4,"Step 2" Section 2 n dbullet, with respect to the text including the statement: , "there may be the potential marginal increase in likelihood of failure, including a single failure.."The statement identified in the bulleted item appears to be from NEI 01-01Section 4.3.2. Where does the "including a single failure" wording come from?Remove the statement "including a single failure" Comment No.Section/Page #Industry CommentRecommended Change23.RIS Attachment Page 4, Section 2.2, Step 2 2 n dbullet, with respect to the text including the statement:"For digital modifications, particularly those that introduce software"What is this intended to mean?-Consider how digital modifications that do not involve software should be defined, as most digital equipment has software/firmware.Examples are discrete logic chips and FPGAs.-"Introduce software" phrase could be taken that this only applies to analog to digital mods. It should also address digital to digital mods-The use of "redundant" should also have independence stated. Please change to redundant and independent. This is a generic comment wherever redundancy is used. Independence is the key word.Redundancy can be added in non-safety systems for reliability purposes only.Please clarify the intent of the use of the term "software" in this section based on the comment.Please consider the use of the term "redundant and independent" versus just the use of "redundant."24.RIS AttachmentPage 4,"Step 2" SectionThisstatement, although out of NEI 01-01, would seem to imply that digital upgrades will always increase the likelihood of failure, which has not been observed in actual practice where, in most cases, digital upgrades have been shown to decrease failure likelihood.Also, in 50.59 it is common practice to consider the balancing of positive effects of installing the digital equipment (e.g., elimination of SPVs, signal validation, etc.) with the potential negative effects (e.g., SCCF, etc.) when arriving at the final conclusion of not more than a minimal increase in malfunction likelihood or accident frequency. The RIS does not appear to discuss using the balancing effects of the positives and negatives of digital upgrades.Add supporting statement(s) that includeacknowledgement of positive, not just negative, impacts of installing digital equipment.Further, rephrase the statementsthat imply that digital systems will always increase the likelihood of failureto include the idea of "no more than a minimal increase" text from


50.59.25.RIS Attachment / Page 4, Section 2.2, Step 2Bullets contain quoted guidance from NEI 01-01 and NEI 96-07, Rev 1; however, the quoted text from the last three bullets could not be traced back to either source.Revise the last three bullets to ensure quoted information is accurate and traceable to the source document.Provide a reference to the source.
INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page #                               Industry Comment                                     Recommended Change
Comment No.Section/Page #Industry CommentRecommended Change26.RIS AttachmentPage 5, Section 3The title of this section is 'Draft Characteristics of Proposed Modifications that Produce Effective Qualitative Assessments'.The first paragraph of this section states:"The NRC staff finds that proposed digital I&C upgrades and modifications having all the characteristics listed below are more suitable to and effective for qualitative assessments and thus more likely to meet the 10 CFR 50.59 evaluation criteria."The title and wording in this section imply that the Qualitative Assessment Framework is permitted only for digital modifications having all the characteristics in this section.It is assumed that the term 'effective' actually means 'produces positive results'.The section reads more clearly without the word 'effective.'Clarify the applicability of the characteristics in this section to digital modifications.Consider changing "Do not" to:"Do not create an adverse condition due to-"Remove 'that Produce Effective Qualitative Assessments' from the title and delete 'more suitable to and effective for qualitative assessments and thus' from the last sentence of the first paragraph to avoid misinterpretation of this section.27.RIS AttachmentPage 5, Section 3 (1)This sub-section states "Digital I&C design function-for-design functionreplacements and upgrades to systems and components that:"Is the qualifier "design function-for-design function" both meaningful and necessary?Unless the phrase "design function-for-design function" provides additional criteria or meaning, it is suggested that it be removed.If the term provides specific meaning, please provide the criteria for determining the function for function alignment.
: 71. RIS Attachment Step 5, first paragraph, evidence of the three qualitative assessment Please provide a reference to an earlier Table 2        justifications.                                                      section in the RIS or RIS Attachment where the three qualitative assessment justifications are provided for completeness.
Comment No.Section/Page #Industry CommentRecommended Change28.RIS AttachmentPage 5, Section 3This section seems to constrain the digital modification to a very limited scope, whichdoes not appear to meet the intent.For instance, it is not clear whether all of the attributes, or some of the constraints needto be met.Applying these in a strict way would eliminate most digital changes being contemplated, or currently being done.For example:a.      "1a)-b)" These conditions appear to only allow designs that don't combine functions that were previously separate (this eliminates DCSs from being considered per this criteria, even if you use segmentation on separate controllers because they communicate via shared network, which is not acceptable).b.      "2" could be construed to eliminate all safety systems that have two channels (chillers) from consideration since they will be digital and identical and this will screen them out before we even get a chance to demonstrate low likelihood of CCF.c.      "3" is just a regurgitation of BTP 7-19 criteria, but the prelude to the section says that all criteria mu st be met, which is pretty much impossible for embedded devices.Clarify the applicability and limitations of these constraints to address potential issues with items noted, such as:-DCS Upgrades-Safety Chillers-Embedded Devices29.RIS AttachmentPage 5, Section 31(a) & 1(b)The exclusion of systems using common HMI eliminates all non-safety related DCS upgrades from this RIS scope.The type of systems that use shared resources should be in scope of this RIS which should describe that the licenseeaddresses combination of functions and spurious operation in the qualitative assessment.
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Comment No.Section/Page #Industry CommentRecommended Change30.RIS Attachment Page 5, 1 stparagraphWith respect to the text including the statement:"-the qualitative assessment results al one are sufficient that software CCF does not need to be assumed-"The use of "software CCF" appears to limit the use of qualitative methods to demonstrate that CCF does not have to be assumed for other types of potential common cause failures.The RIS should clearly define the scope of CCFs(software, etc.)being considered.31.RIS Attachment Page 5, Step 3With respect to the text including the statement:
"Only for possible malfunctions that do not have a sufficiently low likelihood based on the qualitative assessment in Step 2, determine whether the malfunction has a different result."Clarify whether the different result is at the SSC level or plant level.The industry position is that the results are evaluated at the plant level, as discussed in the recent RIS public meeting.32.RIS AttachmentPage 5, 1(b)With respect to the text including the statement:"Do not incorporate new shared resources.....implicitly assumed"Implicit assumptions are impossible to verify.Should provide clarification on whether "system function" equals "design function" and if so, use "design function."Remove "implicitly assumed."33.RIS AttachmentPage 6, Section 3 (2)With respect to the text including the statement:"-.that do not result in reduction of any aspects of independence"This goes beyond reasonable assurance. Adding any software could and does result in a small quantitatively reduction. Please reword with reasonable assurance languageinstead of using "do not."
Comment No.Section/Page #Industry CommentRecommended Change34.RIS Attachment Page 6, item (3)With respect to the text including the statement:"-as demonstrated through 100% testing-"There is a lack of clarity with industry(and perhaps regional inspectors)over what constitutes 100% testing, and this "simplicity" concept. Technical individuals working on the NEI/Industry DI&C teams have come to understand that any device containing software is not considered to be 100% testable, and we must assume a CCF.If this is the case, then this RIS will only work for a very limited number of digital changes. The 100%testing approach does not meet the "qualitative" intent of the RIS, and the reasonable assurance standard.Eliminate the 100% testing criteria as the only test for "simplicity."35.RIS Attachment Page 6, item (3)With respect to the text including the statement:"-bounded by previous FSAR analysis.."Address the use of the term "bounding" with respect to "plant level" in this section, and further define FSAR analysis as "safety analyses-"36.RIS Attachment Page 6, 4 thparagraphWith respect to the text including the statement:"demonstration that the resulting replacement or upgrade design can tolerate the postulated triggering of that defect"This statement would seem to indicate that we must assume a design defect and then assume the design defect is triggered. If this is the intent, the RIS will likely not work for most safety related SSCs (including the safety related chiller mod). If this is not the intent, should clarify the statement.Add a discussion and clarify methods for demonstrating what would be an acceptable way of "tolerating" the triggering of a defect.Clarify the statement to indicate whether a design defect must be assumed or not.Define the basis for the design defect likelihood needing to be "significantly lower."
Comment No.Section/Page #Industry CommentRecommended Change37.RIS Attachment Page 6 last paragraph Page 7, first paragraphWith respect to the text including the statement:"Alternatively, electrical independence can be demonstrated qualitatively-"The real purpose of this RIS is software and SCCF with respect to independence. Using electrical independence may not be the best example for this RIS.Add a clear languagein this paragraph that states,"software also can be addressed in a qualitative manner" and consider using a digital example.38.RIS Attachment / Page 7, Section 4.2A new term, "layers of defense" is used and is not defined.If this is intended to refer to "defense in depth", then "defense in depth" should be stated. Either define the term "layers of defense" or use the term "defense in depth".Alternatively, provide a reference to the USNRC or industry document being used to define "layers of defense."39.RIS AttachmentPage 8, Quality Design ProcessWith respect to the paragraph beginning with:"For digital equipment incorporating software-.."These attributes may not be available or well documented for non-safety related equipment that contains software. NEI 01-01 was primarily written to evaluate changes to safety related SSCs. Quoting this paragraph within the RIS may lead some (including regional inspectors) to believe that all these attributes must be accounted for when implementing a non-safety related digital upgrade with software involved.Clarify this section to acknowledge a different standard applies for non-safety related upgrades.40.RIS Attachment Page 8, Last paragraphWith respect to the text including the statement:"-.thoroughly documented within the licensee's quality assurance (QA) program.."What is specifically meant by "... documented within the licensee's QA program"? Does this mean a formal qualitative assessment document must be developed and placed within the engineering change package for future retrieval?Please clarify the intent of this statement.
Comment No.Section/Page #Industry CommentRecommended Change41.RIS Attachment Page 8, Last paragraphIn section 4.2 the last paragraph on page 8 says "All of these categories should be addressed and thoroughly addressed in the licensee's quality assurance program, in consideration of the safety significance of SSCs described below in Section 4.2 (See table 1)"There may be confusionabout what this means-.to be described in the QA program.Please clarify intent of QA program reference.
Clarify QA program applicability is not based on safety significance of SSCs, but on the licensees Quality Assurance Program.42.RIS Attachment Page 8Page 9, Table 1Please add endorsed EPRI TR-106439 as an acceptable example for digital commercial grade dedication mods.Please add the reference as noted.43.RIS Attachment Table 1For Table 1, the list of acceptable examples, is this list intended to be addressed by each evaluation, or is this just a suggested list? For the design attributes, what is the expectation on behalf of the NRC that there be all items, or some items?Is the determination of adequacy up to the licensee or will this list constitute the basis for a Mods or 50.59 inspection?Please clarify the applicability of the examples cited in Table 1, and their intended use.44.RIS Attachment / Page 9, Table 1"Environmental Qualification" implies a Regulatory programmatic requirement; however, based on the subsequent examples, "(e.g., EMI/RFI, Seismic)", this does not appear to be the context.Revise "environmental qualification" to "demonstrated tolerance (e.g., through qualification testing) to withstand environmental conditions within which the SSC is required to perform its design function (e.g., EMI/RFI, Seismic)."45.RIS Attachment Table 1Design AttributesWatchdog Timers -The RIS should not limit credit for external watchdog timers only. There are designs that have internal watchdog timers that operate independent of the software and are considered just a reliable as external watchdog timers (the digital reference adjuster used on the EDG voltage regulator project is an example of an independent internal watchdog timer).Suggest changing to "Watchdog timers that operate independent of software" or something to that effect.An acceptable alternative might be "Watchdog timers that time out in hardware.".
Comment No.Section/Page #Industry CommentRecommended Change46.RIS Attachment Table 1Design Attributes"Sufficiently simple" and 100% testing are used here.See previous comments on this subject.Suggest acknowledging other types of testing to demonstrate the design is sufficiently simple, such as comprehensive, or exhaustive testing, versus just 100% testing.47.RIS Attachment Table 1Design AttributesFailure state always know to be Safe-An acceptable failure state could also simply be equivalent to the failure state of the device being replaced, not necessarily to the safe state. Revise to describe that the failure state of the new digital equipment can be the same as the failure state of the existing equipment (whether or not the failure state is considered safe).48.RIS Attachment Table 1 Operating ExperienceThe last bullet indicates that high volume commercial products are less likely to have deficiencies.Augment the discussion to suggest that "High volume, high quality commercial products with applicable operating history used in other applications have the potential to not include as many design errors."49.RIS Attachment Page 10, 4.2.1.1This paragraph does not clearly distinguish between safety related and non-safety related SSCs. Digital communications (ISG-04) is a concern primarily with Safety Systems and is not applicableto non-safety systems.Thoughthere is very good guidance in ISG-04, this section seems to make it required to be addressed for all classes of systems that might be evaluated by this process.Would digital communication between non-safety SSCs considered out-of-scope of this RIS?
For example, a plant may have two (redundant) feedwater pumps -not for plant safety but for operational convenience. Would digital communication between the two feedwater pump controllers be out-of-scope for this RIS?Please clarify applicable scope for digital communications criteria, to clearly specify that ISG-04 is applicable to only safety related modifications.Please clarify to address how this might be applied to non-safety related examples.Also, while ISG-04 is good guidance, and has been in place for more than a decade, it would be preferable to refer to more durable guidance.
Comment No.Section/Page #Industry CommentRecommended Change50.RIS Attachment Page 10, 4.2.1.2For section 4.2.1.2 the gist of this section is that combination is bad in all cases, however, there are cases where combination of previously separate components results in a more dependable system due to the tightly coupled nature and a reduction in complexity. A good example is the combination of Main Feed regulating valves with Feed bypass valves into one controller, this has allowed the industry to use one controller to control steam generator level through all power levels, where previously there was a manual cross over at a low power that often resulted in spurious level changes and plant trips due to loss of level control, those types of plant upsets are much less frequent with a combined system where both valves are controlled by one controller.A plant transient from both a bypass and MFRV may not be evaluated in the License but if the overall result from combining the two is a marked increase in dependability, in the aggregate.Revise to acknowledge cases where combination of functions may result in a more reliable and safer system.51.RIS Attachment Page 10, 4.2.1.2, 3 rdsentenceWith respect to the discussion on combination of functions:This section should acknowledge that combination of functions is allowable where it does not create an adverse condition; the 3 rdsentence does not accurately reflect verbiage consistent with 10 CFR 50.59.Please add language that allows combination of functions where it doesnot create an adverse condition.52.RIS Attachment / Page 10, 4.2.1.2, last sentenceThe phrase "the other NRC-approved processes" does not provide guidance.If "the other NRC-approved processes" is intended to be license amendment request, so state. Else,defineall the other processes that could be followed.53.RIS Attachment Page 10, 4.2.2This section should include reference of EPRI TR-106439 as an acceptable example for digital commercial grade dedication mods.Add the noted reference.
Comment No.Section/Page #Industry CommentRecommended Change54.RIS Attachment Page 11There is no expanded discussion on the Operating Experience topic.Sections 4.2.1 and 4.2.2 expand on the other "bullet" points noted on Page 7 and Page 8 of the attachment (Design Attributes and Quality Design Process).Revise document to use Section 4.2.3 as an expanded discussion on Operating Experience.Move current Section 4.2.3 content to another section of the document.55.RIS Attachment Page 11, 1 stparagraphQuality Standards -please clarify the use of the term "quality standards" in theRIS.If the intent is to define a high quality design process, then the licensee Appendix B program should govern the activities as applicable. It should be noted that there is no requirement for mandatory use of any other type of quality standard for non-safety related applications.
Clarify the use of the term "quality standards."56.RIS Attachment Figure 1It appears that the YES/NO labels should be reversed on the diamond near the top of the page which states "Does the proposed change have the characteristics describedin the attachment to the RIS?"Also, the first box appears to be selecting criteria.That is, if the characteristics don't match (e.g. no combinations, no communications, etc.) they you can't use this process.If you exit the RIS 2017-xx process, then areon your own to useNEI 01-01 as originally endorsed in RIS 2002-22?Flip the YES / NO labels.Suggest being more specific by adding a specific section number of the RIS that details the characteristics. (RIS Section 3?)Consideran exit to this process that shows the previous RIS/NEI 01-01 process.57.RIS Attachment Figure 1The flowchart only addresses 50.59 Evaluations Questions 2 and 6. Questions 1 and 5 do not appear to be addressed in the flowchart.Suggest addressing Questions 1 and 5.58.RIS Attachment Figure 1Conduct the Technical Analysis and Assess Vulnerabilities is split into two boxes, but in reality the vulnerabilities will be assessed in the design change (in the box that feed into the Conduct Technical Analysis).Is this split into two boxes because the RIS expect two distinct documents? Or do both of the boxes constitute the single "Qualitative assessment" as outlined in Table 2.The assumption isthat it is broken out based on some thought model held by the staff, but in actuality this is all done under the design change process and is only documented in the 50.59 as a high level summary with sufficient detail to assist the approver of the 50.59 (and to support the NRC review under Mods inspections).Provide explanation as to why this process is split into 2 boxes, and/or update Figure 1.
Comment No.Section/Page #Industry CommentRecommended Change59.RIS Attachment Page 13, Section 5.1This section appears to be written for safety-related software. In most cases, the evidence required in Section 5.1 would be difficult to compile for non-safety software containing COTS devices.Update this section to reflect the level of documentation that might be typically seen for non-safety related upgrades.Augment the "software safety analysis" to "software safety analysis (as applicable)" to capture the non-safety related equipment.60.RIS Attachment Page 13, Section 5.1In Section 5.1 there is a statement that says that the Qualitative Assessment should provide evidence that a well-defined process for -andit continues on witha statement of components from BTP 7-14, which again is only applicable to safety-related software and would also be germane (but not required) for non-safety related software.What if any concessions are allowed for those non-safety and even those components that are Commercially dedicated where we will often credit extensive operating history and testing along with "largely equivalent" software processes, where portions of the software lifecycle are less relevant and not needed to make the Qualitative Assessment for less risk significant system that screen into 50.59 evaluation?See comment below on section 5.2Revise document to addressthe software process typically seen fornon-safety related and commercially dedicated equipment.
Comment No.Section/Page #Industry CommentRecommended Change61.RIS Attachment Page 13, Section 5.2 In Section 5.2 there appears to be a hint of grading by safety significance, which is in keeping with the original NEI 01-01, but the two lists are not well defined, are you saying that the items on the list constitute a risk significant system? Are they in any order of risk significance, or are they all considered equally risk significant?With the contrary being deemed less risk significant and therefore less documentation required and the second list seems to have a functionbased criteria. Same question as above, (all risk significant;any sort of hierarchy implied?).Will this grading be up to the utility? Or will this RIS address which would be acceptable?Please clarify basis and applicability of these grading criteria.62.RIS Attachment Page 13, Section 5.2 2 n dbullet -With respect to the term "accident mitigation system"Is this statement referring to accident mitigation systems that are credited in the safety (or accident) analysis? There are some non-safety systems that can be used for accident mitigation but are not credited in the safety (accident) analysis (e.g., off-site power is the preferred source of power for mitigating accidents but is not generally credited as an accident mitigator in the safety (accident) analysis). There is some confusion in the industry when it comes to defining a SSCs that are considered accident mitigators.Suggest clarifying by stating "... accident mitigation system credited in the safety analysis."63.RIS Attachment Page 14, last paragraphWith respect to the following statement:
"It is the responsibility of the licensee's 10 CFR 50.59 evaluator to demonstrate that the documentation of the design basis-"Request this section be clarified to differentiate between where design basis information is documented (for instance, the plant modification process), versus where licensing basis information is documented (for instance in the 50.59 evaluation).
Comment No.Section/Page #Industry CommentRecommended Change64.RIS Attachment Table 2 Step 1, last bullet:Please add clarification that the evaluation should consider both active and inactive states.Add clarificationas described in comment.65.RIS Attachment Table 2 Step 1, 3 r dbullet -Safety and power generation functions.Please clarify what this statement is asking for, it is not entirely clear.66.RIS Attachment Table 2Step 3 -Enhanced Safety Analysis.Please define or clarify what "enhanced" is referring to.67.RIS Attachment Table 2Step 3 -Failure Modes.Please add a note stating that the failure mechanisms can change. Please add a note allowing us to eliminate failure modes of the original equipment in the replacement equipment.68.RIS Attachment Table 2Step 4 -last paragraph, beginning with -"All assertions
-"This statement implies that the licensee must assume a CCF.If this is the case, please explain.If this is not the case, please reword or provide clarification.69.RIS Attachment Table 2In Table 2:Steps 4 and 6 seem to be repeats, you make the assertions and provide the evidence, then repeat the assertions.If not repeats, but rather two steps in a process, where identification is done in one step, and verification of resolution is provided in a separate process, then suggest clarification.Leave one or the other out, the evidence needs to support the assertions either way.Clarify why the two steps are provided.70.RIS Attachment Table 2 Step 5, 2 n dparagraph, "vectors to malfunctions."If definition exists, please provide it; otherwise recommend deletion.
Comment No.Section/Page #Industry CommentRecommended Change71.RIS Attachment Table 2Step 5, first paragraph, "evidence of the three qualitative assessment justifications."Please provide a reference to an earlier section in the RIS or RIS Attachment where the three qualitative assessment justifications are providedfor completeness.}}

Revision as of 19:09, 21 October 2019

(External_Sender) Public Comments Related to Digital I&C RIS 2002-22, Supplement 1 - FW: NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket Id: NRC-2017-0154)
ML18054A045
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Site: Nuclear Energy Institute
Issue date: 08/16/2017
From: Fregonese V
Nuclear Energy Institute
To: Wendell Morton
Division of Engineering
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NRR-DMPSPEm Resource From: FREGONESE, Victor <vxf@nei.org>

Sent: Wednesday, August 16, 2017 4:05 PM To: Morton, Wendell; Rahn, David

Subject:

[External_Sender] FW: NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)

Attachments: 08-16-17_NRC_NEI 17-XX-Industry-Comments-NEI-Cover Letter.pdf; 08-16-17

_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-General Comments_Attachment1.pdf; 08-16-17_NRC_NEI_17-xx-Consolidated Industry Comment-8-16-17-Editorial Comments_Attachment2.pdf; 08-17-17_NRC_NEI 17-xx-Consolidated Industry Comment-8-16-17-Clarification Comments_Attachment3.pdf Vic Fregonese Senior Project Manager Nuclear Generation Division Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004 www.nei.org M: 704-953-4544 E: vxf@nei.org From: HANSON, Jerud Sent: Wednesday, August 16, 2017 4:04 PM To: cindy.bladey@nrc.gov Cc: Jason.Drake@nrc.gov; john.lubinski@nrc.gov

Subject:

NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)

THE ATTACHMENT CONTAINS THE COMPLETE CONTENTS OF THE LETTER August 16, 2017 Ms. Cindy Bladey Mail Stop: TWFN-8 D 36M Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)

Project Number: 689

Dear Ms. Bladey:

1

The Nuclear Energy Institute (NEI)[1] and the industry appreciate the opportunity to provide integrated industry comments on the Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22. The purpose of this RIS is to clarify the NRCs endorsement of NEI 01-01 by providing additional guidance for preparing and documenting the qualitative assessment used to provide reasonable assurance that a digital modification will exhibit a low likelihood of failure, which is a key element in 10 CFR 50.59, Changes, tests and experiments, evaluations of whether the change requires prior NRC approval. This RIS supports our mutual interest in more efficient and effective licensing of digital upgrades across the operating fleet and we look forward to issuance in the third quarter of 2017. Our principal comments are included below and more detailed comments are presented in the attachments for consideration by the NRC staff.

We appreciated the opportunity to participate in a public meeting to conduct a tabletop exercise utilizing the draft RIS 2002-22 Supplement for Digital I&C upgrades at nuclear power reactor facilities under 10 CFR 50.59 on August 2, 2017. The draft RIS provided an effective framework for conducting digital upgrades within the scenarios that were demonstrated.

We appreciate the opportunity to comment on the Draft RIS. If you have any questions or require additional information, please contact me.

Sincerely, Jerud Hanson Senior Project Manager, Life Extension & New Technology Nuclear Energy Institute 1201 F Street N.W., Suite 1100 Washington, DC 20004 www.nei.org P: 202.739.8053 M: 202.497.2051 E: jeh@nei.org The link ed image cannot be display ed. The file may hav e been mov ed, renamed, or deleted. Verify that the link points to the correct file and location.

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The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.

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[External_Sender] FW: NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)

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JERUD E. HANSON Senior Project Manager, Life Extension & New Technology 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8053 jeh@nei.org nei.org August 16, 2017 Ms. Cindy Bladey Mail Stop: TWFN-8 D 36M Office of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

NRC Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22 (Docket ID: NRC-2017-0154)

Project Number: 689

Dear Ms. Bladey:

The Nuclear Energy Institute (NEI) 1 and the industry appreciate the opportunity to provide integrated industry comments on the Draft Regulatory Issue Summary 2017-XX Supplement to RIS 2002-22. The purpose of this RIS is to clarify the NRCs endorsement of NEI 01-01 by providing additional guidance for preparing and documenting the qualitative assessment used to provide reasonable assurance that a digital modification will exhibit a low likelihood of failure, which is a key element in 10 CFR 50.59, Changes, tests and experiments, evaluations of whether the change requires prior NRC approval. This RIS supports our mutual interest in more efficient and effective licensing of digital upgrades across the operating fleet and we look forward to issuance in the third quarter of 2017. Our principal comments are included below and more detailed comments are presented in the attachments for consideration by the NRC staff.

We appreciated the opportunity to participate in a public meeting to conduct a tabletop exercise utilizing the draft RIS 2002-22 Supplement for Digital I&C upgrades at nuclear power reactor facilities under 10 CFR 50.59 on August 2, 2017. The draft RIS provided an effective framework for conducting digital upgrades within the scenarios that were demonstrated.

1 The Nuclear Energy Institute (NEI) is the organization responsible for establishing unified industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEI's members include all entities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel cycle facilities, nuclear materials licensees, and other organizations and entities involved in the nuclear energy industry.

Ms. Bladey August 16, 2017 Page 2 Application to safety-related systems The scope of the RIS and attachment should be clearly stated as intended to be used for safety-related systems only. It should be clear that the RIS could, or might be used as guidance for non-safety related upgrades only if desired by licensees. Therefore, industry requests that the RIS should provide sufficient clarity to avoid an interpretation that it is viewed as mandatory for non-safety related systems. Comment

  1. 1 within attachment #1, provides suggestions to address this point.

Impact on digital system common cause failure The draft RIS is characterized as a means to allow for low risk (non-protection systems) changes to safety systems to go forward under 50.59, but there is no discussion of risk considerations. Instead, it includes a recommended level of rigor for the engineering evaluations needed to support the 50.59 process without providing any assurance that these will be accepted for low risk systems. These low risk systems have been incorrectly included in the current NRC staff position on common cause failure (CCF) policy, due to changes over time to Branch Technical Position (BTP) 7-19. It should be clearly stated how the RIS impacts the current NRC policy/position that addresses digital system CCF. Comment #2 within attachment #1, provides suggestions to address this point.

Application to non-power reactors This RIS should be applicable to include non-power reactors (NPRs). Relevant guidance contained within NEI 96-07 and RG 1.187 is applicable to NPRs, and digital upgrades at NPRs should be addressed within this RIS. Comment #3 within attachment #1, provides suggestions to address this point.

We appreciate the opportunity to comment on the Draft RIS. If you have any questions or require additional information, please contact me.

Sincerely, Jerud E. Hanson Attachments c: John W. Lubinski, NRR, DE c: Jason Drake, NRR, DE

INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - General Comments Comment No. Section/Page # Industry Comment Recommended Change

1. General The scope of the RIS and attachment needs to be limited to safety-related Clearly state the applicability of the RIS and systems only. attachment is intended to be used for safety It should be very clear that the RIS could, or might be used as guidance for related systems only.

non-safety related upgrades if desired. The RIS should provide sufficient clarity to avoid an interpretation that it is to be viewed as mandatory for non-safety related systems.

2. General The Draft RIS was characterized as a means to allow for low risk (non Describe how the RIS impacts the current protection systems) changes to safety systems to go forward in 50.59, but NRC policy/position documents that address there is no mention of any sort of risk considerations in the Draft RIS. digital system CCF, such that end users of Instead it mainly provides a recommended level of rigor for the engineering the RIS are clear how, or if, other NRC CCF evaluations needed to support the 50.59 without providing any assurance policy/position documents apply to the that these will be accepted for low risk systems that have been incorrectly activities within the scope of the RIS.

pulled into the CCF policy due to changes to BTP 7-19. Nowhere in this RIS is a statement on scope of the policy on CCF, in fact it seems to reinforce the current content of BTP 7-19 into not only safety related components but non safety components that are in the licensee design basis.

1

INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - General Comments Comment No. Section/Page # Industry Comment Recommended Change

3. General The non-power reactor community was not included in consideration of this Please include non-power reactors within RIS. the scope of the RIS.

At the May 25, 2017 public meeting on this proposed RIS there was discussion of the importance of including non-power reactor licensees within this proposed RIS. The general consensus was that non-power reactors should be included within its scope. It appears that the exclusion of non-power reactors from RIS 2002-22 was likely an oversight. EPRI TR-102348 and Generic Letter 95-02 are referenced in NUREG-1537, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors, for use by the non-power NRC staff and licensees in licensing DI&C upgrades. Though they followed after the issuance of NUREG-1537, the revision to EPRI TR-102348 (NEI 01-01) and related RIS 2002-22 are also used by the non-power NRC staff and licensees in licensing DI&C upgrades. NEI 96-07 and associated RG 1.187 are also applicable to non-power reactor licensees.

4. General The RIS does not specify whether the NRC expectation is that the Add a statement that the RIS is intended to Qualitative Assessment guidance is to be used for 50.59 screening. be used for 50.59 evaluations, but may be consulted during the 50.59 screening process.

2

INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page # Industry Comment Recommended Change

1. Draft RIS Page 1 In the ninth line of this paragraph, please augment the implicit statement of Replace this RIS is to clarify the NRCs Intent Paragraph applicability to ensure that the reader recognizes that RIS 2002-22 is being endorsement of NEI 01-01 with this supplemented rather than supplanted. The text does not make this supplemental RIS clarifies still-active RIS extremely clear and unambiguous. 2002-22 that endorsed NEI 01-01
2. Draft RIS Page 2 Background Information section, first full paragraph, Correct the title of NEI Correct text as noted.

Section titled 96-07, Evaluations should be Implementation.

Background

Information

3. Draft RIS Page 3 At the end of the last sentence in the paragraph starting Specifically, this Revise from methods to demonstrate the Section titled RIS add words that clarify that the problem is in software. likelihood of failure Summary of To Issue Section

.methods to demonstrate the likelihood of failure from software design errors

4. Draft RIS Page 4 For readability, please consider bolding these italicized section headers to Use bold text for section headers.

Section titled make them stand out in the rest of the text.

Clarification of Guidance for Addressing Digital I&C Changes under 10 CFR 50.59 1

INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page # Industry Comment Recommended Change

5. Draft RIS Page 4 In the second full paragraph, second line, the word appropriate is Replace appropriate with something more Section titled ambiguous. like applicable Clarification of Guidance for The last sentence in this paragraph is very long. Split the last sentence into applied to the Addressing Digital proposed design. Using such standards I&C Changes under 10 CFR 50.59
6. Draft RIS Page 4 In the paragraph starting To assist licensees, the second line, the Replace the NRC staff has clarified Section titled sentence should be simplified. within the attachment to this RIS its Clarification of position with the attachment to this Guidance for RIS clarifies the NRC staff position Addressing Digital I&C Changes In the last sentence of this paragraph, delete under 10 CFR clarification within the as the 50.59 attachment describes is sufficient.
7. Draft RIS Page 4 In the next to last line of the first paragraph, it is not clear what alter the Replace alter the conclusions of by the Section titled conclusions of means to a licensee. safety analysis with alter the conclusions Clarification of of or not be bounded by the safety analysis Guidance for in the UFSAR Addressing Digital I&C Changes under 10 CFR 50.59 2

INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page # Industry Comment Recommended Change

8. Draft RIS Page 4 In the first paragraph, please reiterate that this RIS supplements, but does Replace supplements RIS 2002-22 Section titled not supersede, RIS 2002-22. with supplements but does not Backfitting and supersede RIS 2022-22 Issue Finality Discussion In the second paragraph, the first sentence does not define on whom the Rework the first sentence in the second guidance might be imposed. paragraph.
9. RIS Attachment, The first paragraph, first sentence is excessively long, with the result of Replace 10 CFR 50.59 Rule, for use as page 1, Purpose being difficult to read and understand. guidance for implementing with 10 CFR 50.59 Rule. This RIS provides guidance for implementing
10. RIS Attachment, In the second paragraph, reinforce that this is a supplemental RIS. Change to provide clarifying guidance page 1, Purpose with to provide supplemental clarifying guidance Change Following this guidance will help with Following the guidance in the RIS 2022-22 and NEI 01-01, as augmented by the guidance in this RIS
11. RIS Attachment, This second would be easier to find if it were set in bold type. Change the format to bold on all section page 1, headers throughout the attachment, Likelihood including those that are underlined.

Justifications

12. RIS Attachment In the first paragraph, last sentence, there are extra words, and a missing Delete both that in the sentence, and Page 2, reference to where the characteristics that should be evaluated are defined. replace there are some important with Regulatory several important.

Clarification Provide some reference, even within the RIS, to the important characteristics that we should evaluate.

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INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page # Industry Comment Recommended Change

13. RIS Attachment In the paragraph starting 10 CFR 50.59 (c)(2)(vi) in the fourth line, that is Replace reasonable assurance the Page 3 missing. likelihood with reasonable assurance that the likelihood
14. RIS Attachment Bullets contain quoted guidance from NEI 01-01 and NEI 96-07, Rev 1; Revise bullets 1 and 3 to ensure the quoted Page 4, Section however, in a couple cases, the quoted information is not correct. text is accurate and traceable to the source 2.2, Step 1 document.
15. RIS Attachment Delete the entire paragraph beginning with: Documentation is needed.. Replace with the following:

Page 7, last paragraph Documentation is needed to demonstrate the proposed design will not create malfunctions with different results or initiate a different type of accident not previously analyzed in the UFSAR. Within the concept of layers of defense, acceptable justification for concluding an accident of a different type will not be initiated to include the postulated new accident is only possible after a sequence of multiple unlikely independent failures. This type of justification should also be documented as part of the qualitative assessment.

16. RIS Attachment In the last line, a reference to the major section we are in is not helpful. Either revise Section 4.2 to be more Page 8 useful, or remove the reference to a general section in the RIS Attachment.
17. RIS Attachment In the second paragraph, the subject (software and hardware) is plural. Replace modification has with Page 8,Operating modification have Experience In the last sentence, the phrase along with consideration of the supplier of Add commas before and after the phrase.

such equipment should be set off in leading and trailing commas.

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INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page # Industry Comment Recommended Change

18. RIS Attachment 2nd paragraph. Revise the following from:

Page 9, 4.2.1 .do not result in a potential.

To:

do not result in more than minimal

19. RIS Attachment In the first paragraph, last sentence, it might be clearer if the three steps in Please consider clarification of this Page 9, 4.2.1 the justification were numbered (e.g., 1) a thorough description of the , paragraph. Delete thorough.
2) the design attributes..., and 3) a clear description Further, it is not clear how extensive thorough is expected to be.
20. RIS Attachment Sentence beginning with If the qualitative assessment.. Revise the following from:

Page 10, 4.2.1.2 ..a new type of accident, a malfunction with a new result, or an unbounded malfunction or accident now exists due to the combing of functions creating new malfunctions, or new inter-system interactions, etc, then..

To:

a new type of accident or, a malfunction with a different result now exists due to the combination of functions, then.

21. RIS Attachment First paragraph. Revise the following from:

Page 10 .the potential for new malfunctions or accidents should be evaluated.

To:

the potential for malfunctions with a different result or accidents of a different type should be evaluated 5

INDUSTRY COMMENTS ON DRAFT RIS 2017-xx, SUPPLEMENT TO RIS 2002-22 Attachment 1 - Editorial Comments Comment No. Section/Page # Industry Comment Recommended Change

22. RIS Attachment The first sentence is too long. Replace development organization that Page 11, 1st provides for common and repeated use, paragraph rules with development organization.

These quality standards provide rules and move for common and repeated use to the end of the sentence, replacing context with context, for common and repeated use.

23. RIS Attachment In the last sentence of the first paragraph, there are extraneous words and In the last sentence of the first paragraph, Page 11, 4.2.3 an imprecise set of references. delete other avenues for performing the change, i.e., and list all avenues.
24. RIS Attachment In the first sentence of the last paragraph, there are extraneous words. Replace guidance provides the kind of Page 11, 4.2.3 process that should be engaged when using this guidance with .. guidance illustrates the process to use this guidance.
25. RIS Attachment The diamond near the top of the page states Does the proposed change Change the phrase to state Does the Figure 1 have the characteristics described in the attachment to the RIS?. It is proposed change have the characteristics suggested that the characteristics being reference be pointed out described in RIS attachment section 3?

specifically in the RIS attachment.

26. RIS Attachment The second decision block language is not consistent with the verbiage Revised the second decision block question Figure 1 used in 10 CFR 50.59. verbiage to align with 10 CFR 50.59.

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27. RIS Attachment Step 1. Revise wording from:

Table 2 What are all of the UFSAR design functions..

To:

What are all of the UFSAR described design functions Alternatively, What are all of the design functions described in the UFSAR

28. RIS Attachment Step 4, 2nd bullet. Revise wording from:

Table 2 The digital components likelihood of postulated CCF likelihood To:

The digital components postulated CCF likelihood

29. RIS Attachment Step 3. Revise wording from:

Table 2 Could those potential impacts already be bounded by the results of the design basis analyses, or would the analyses need to be revised to address it?

To:

Are potential impacts already bounded by results previously evaluated in the UFSAR or would the safety analyses need to be revised to address potential impacts?

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

1. ALL The DRAFT RIS uses the term, qualitative assessment more than 15 Define the term qualitative assessment times throughout the RIS. In the context where it is used, in most case, once, then only use the term in the balance either an implicit or explicit definition is stated. This is confusing. of the text.

Also, in a few random cases effective qualitative assessment is used. This Suggest using a definition that states that DRAFT RIS does not define the differences between the two. Overall, the purpose of the qualitative assessment is effective qualitative assessment seems out of place because either the to demonstrate reasonable assurance of conclusions of a qualitative assessment support the outcomes when used in adequate quality and low likelihood of failure a 10 CFR 50.59 Review or they do not through a review of the system design process and design features. This would be consistent the with NEI 01-01 discussion of dependability (page 5-14).

For clarity and to avoid confusion, remove the word effective from effective qualitative assessment throughout the text.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

2. ALL The terms safety significance and safety significant are used throughout Suggest using important to safety as this section without formal definitions. defined in the UFSAR as it has a formal It is noted that use of these terms is limited to defining the level of regulatory definition associated with the documentation that is worthwhile and is not used as input to answering the design basis.

50.59 questions.

The scope of the draft RIS is such that the definition of safety significant is not consistent with its use in other regulatory applications The term safety significant as used in regulatory applications today generally has a definition that is much broader than just the licensing basis for the plant and often includes risk-insights (e.g., see the definition of safety significant in 10CFR50.69). Throughout the Qualitative Assessment Framework, review of the modification under 50.59 is restricted to the plant design basis as documented in the UFSAR. As the Qualitative Assessment Framework clearly is limited to the licensing basis for the plant and is neither risk-informed nor considers risk insights, the term safety significant should be avoided and replaced with a regulatory term having a formal definition applicable to the scope of this guidance, important to safety (as defined in the UFSAR).

3. Draft RIS The term reasonable assurance is used here and in footnote 1. No basis Remove the footnote, or, further define the Page 1 is provided for use of a different standard as used in the RIS, versus the term adequate degree of certainty.

Intent Paragraph broader regulatory standard. What is the source for the footnote?

Identify the Regulatory sources of the Having different definitions of this term will cause confusion. As an example, footnote that clearly defines the difference the RIS uses the term reasonable assurance nearly 20 times throughout between adequate degree of certainty and the document in various contexts. In many cases, the RIS includes quotes broader NRC regulatory standard.

from NEI 01-01 with this term included.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

4. Draft RIS Page 2 In the third full paragraph, fifth line, reinforce the idea that this supplement is Replace This RIS supplements the NRC Section titled to be used with RIS 2002-22. Staffs previous endorsement of the NEI 01-Background 01 guidance with This RIS supplements Information the still-active RIS 2002-22 endorsement of NEI 01-01 guidance At the end of the paragraph, explain that this RIS is expected to provide the additional detail necessary to ensure resolution of the issues that have occurred when applying RIS 2002-22 and NEI 01-01.
5. Draft RIS Page 2 In the last full paragraph on this page, IAP MP #1 is mentioned in the Explain how the CCF portion of the Section titled context of 50.59. modernization plan interacts with the 50.59 Background evaluation in the RIS discussion.

Information

6. Draft RIS With respect to the text including the statement: there may be a potential Clarify this statement to be clear that digital Page 3 for a marginal increase in the likelihood of malfunctions upgrades are not always expected to Summary of Although this statement paraphrases NEI 01-01, Section 4.3.2, it seems to increase malfunction likelihood.

Issue Section imply that digital upgrades will always result in a marginal increase in malfunction likelihood. In practice, industry has observed the opposite - that Rephrase to use the no more than minimal digital upgrades tend to decrease malfunction likelihood as most digital increase text from 50.59.

upgrades eliminate single points of vulnerability, provide for signal validation, afford internal diagnostics and alarming capabilities - to name just a few characteristics that go beyond the capabilities of their analog counterparts.

This sentence may cause confusion within industry and with regional inspectors if it is interpreted to mean that digital upgrades are expected to increase malfunction likelihood.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

7. Draft RIS The sentence leading into the last paragraph on the page: Please clarify whether there is a change in Page 3 The RIS pulls out a statement from RIS 2002-22 and states that the Draft NRC staff position from what was previously Section titled RIS does not change NRC staff position, which apparently is that NEI 01-01 endorsed in NEI 01-01.

Summary of provides an acceptable means. This seems to be at odds with the Issue Section statements in the final two paragraphs of this section that the appendix will provide content, rationale and evaluating factors to be addressed, along with a short list of design attributes primarily drawn from the existing BTP 7-14.

8. Draft RIS With respect to the text including the statement: ensuring that the Suggest deleting this portion of the sentence uncertainty of qualitative assessments is sufficiently low as it may cause confusion.

Page 4, Section What is meant by this statement? Generally speaking, the qualitative titled Clarification assessment is used to draw the conclusion that the digital change has a low of Guidance for likelihood of failure.

Addressing Digital I&C Changes under 10 CFR 50.59

9. RIS Attachment / The attachment seems to explicitly specify a quality process, structure and In the Purpose section of the Attachment, Pages 1-17 format for the qualitative assessment that if left without clarification, could It should be made clear that the format, result in a significant impact on the industry in the areas of procedures, content, and structure of the Attachment is qualification, and training, if the interpretation is that the qualitative an example of what an acceptable assessment attributes are viewed as mandatory. Qualitative Assessment could contain, and that the implementation details are up to the licensee.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

10. RIS Attachment / Outcomes from a qualitative assessment that would in turn be used as Recommend that the outcome of a Pages 1-17 engineering/technical information in a 10 CFR 50.59 review are specified as qualitative assessment be described as finds, final determination, resulting, etc. This inconsistent verbiage is conclusions because conclusions are the confusing. translation of the results. Therefore, the Examples of this are: conclusions of an assessment are the Section 2.1, last paragraph engineering/technical information that is Page 2 of 17, 3rd paragraph important to the 10 CFR 50.59 review.

Section 3, 1st paragraph

11. RIS Attachment In section 2.1 (likelihood justifications) the attachment discusses the link Recommend reconciling the use of Page 2, 1st between dependability and likelihood of failures, but in the next to the last reliability versus dependability in the Paragraph paragraph, there seems to be an interchangeable use of reliability and documents.

dependability, recommend sticking to dependability. Furthermore, the inclusion of reliability in the next to the last paragraph in this section is a miss-representation of NEI 01-01 which makes this point that for some high risk systems, there may be a need to provide additional assurance of adequate defense in depth and diversity. Since there is no mention of this, in the section, it can only be implied that all changes, without regard to risk will require a demonstration of defense in depth, but some systems do not require defense in depth because there is no requirement to do D3, but this could be construed to put that requirement onto the licensee.

12. RIS Attachment This section discusses a reasonable assurance standard for evaluating low Revise section to include a statement that Page 2, 3rd likelihood of failure. captures the following concept:

Paragraph Its important to note that the new digital equipment must only be as The new digital equipment is not held to a reliable/dependable as the equipment it is replacing. The likelihood of failure higher standard than the analog (or even is relative to the equipment being replaced. digital) equipment it is replacing.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

13. RIS Attachment With respect to the text including the statement: Remove this statement from the paragraph, Page 2, 7th (whether or not classified as safety-related in accordance with 10 CFR Part and if still necessary, place it elsewhere in Paragraph 50, Appendix B) the text, in a context that is not tied to 50.59.
14. RIS Attachment Section 2 of this document is titled regulatory clarification, but later in 2.2 it Delete or include in Section 4.

Page 3, Section seems to provide a framework for evaluating malfunctions of a different 2.2 result, I think this is better handled in Appendix D or is sufficiently covered in 96-07, since there is really no new guidance here, any attempt to provide it (which it seems you didnt in step #3), then I recommend this part be deleted. If the framework is deemed important include it in section 4.

15. RIS Attachment With respect to the text including the statement: Recommend one term be defined and used Page 3, 2nd .the likelihood of common-cause failure (CCF) is much lower than consistently throughout the document.

Paragraph The term much lower is used several places in the document, as well as the term significantly lower.

16. RIS Attachment With respect to the text including the statement: This limitation also should be reflected the Page 3, 2nd .reasonable assurance the likelihood of common-cause failure (CCF).. RIS.

Paragraph NEI 01-01 uses terminology similar to this and, by inference, is endorsed by RIS 2002-22. However, the applicability of the NEI guidance is limited to software failures (including common cause failures) and does not include other sources of CCF (such as hardware failures).

17. RIS Attachment With respect to the text including the statement: Clarify this section.

Page 3, 3rd The above likelihood thresholds Paragraph This conclusion in this section is acceptable, provided the applicability of the CCF statement of the 10CFR50.59(c)(2)(vi) threshold is limited to software failures. Otherwise the statement expands the scope of consideration CCF under 50.59 to well beyond the original RIS, NEI 96-07, the SRP, RG 1.70 and ANS/ANSI 51.1 & 52.1.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

18. RIS Attachment With respect to the text including the statement: Please clarify meeting the above Page 3, 5th For activities that introduce a potential failure mode (e.g., CCF) that does thresholds Paragraph not meet the above thresholds This section would be acceptable, assuming meeting the above thresholds means the likelihood of common-cause failure (CCF) is much lower than the likelihood of failures that are considered in the UFSAR (e.g., single failures) and comparable to other CCF that are not considered in the UFSAR. If not clarified, this statement expands the scope of consideration CCF under 50.59 to well beyond the original RIS, NEI 96-07, the SRP, RG 1.70 and ANS/ANSI 51.1 & 52.1.

Where CCF has been included in the licensing basis of the plants in the past, it has required a regulatory analysis and gone through rulemaking (e.g, ATWS and SBO). Such a regulatory analysis has not been performed for digital CCF.

The statement also is inconsistent with the SRM to SECY 93-087 and BTP-19 which state that CCF is beyond the design basis.

19. RIS Attachment / The following NOTE is stated, [Note: This likelihood threshold is not Identify the Regulatory source of the Note or Page 3, Section interchangeable with that for credible/not credible, which has a threshold revise the Note to add sufficient clarity 2.1 of as likely as (i.e., not much lower than) malfunctions already assumed (preferably with examples) to ensure it is not in the UFSAR.] mistranslated by the industry.

However, no basis for the note could be found in NEI 01-01 or NEI 96-07, Rev 1, or regulatory framework.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

20. RIS Attachment With respect to the text including the statement: Add the following clarification/definition:

Page 4,Step 1 for the purpose of the 10 CFR 50.59 evaluation, credible Section malfunctions.. For the purposes of the technical evaluation, It is not clear that a credible malfunction considered in the technical a CCF can be considered credible only if the evaluation is the same as a credible malfunction considered in the 50.59 likelihood of a CCF caused by an I&C failure process. source is greater than the likelihood of a CCF caused by other failure sources that are not considered in a deterministic safety analysis described in the UFSAR.

21. RIS Attachment Bullet nine - with respect to the text including the statement: This need to be reworded to something that Page 4, Section malfunctions previously thought to be incredible. is bounding within the plant design basis.

2.2, Step 1 Step 1 in this process is to develop a list of possible malfunctions. Listing malfunctions that are previously thought to be incredible is not verifiable criteria and opens up the evaluation to any possible combination of failures (i.e., unrelated multiple failures).

22. RIS Attachment 2nd bullet, with respect to the text including the statement: Remove the statement including a single Page 4,Step 2 , there may be the potential marginal increase in likelihood of failure, failure Section including a single failure..

The statement identified in the bulleted item appears to be from NEI 01-01 Section 4.3.2. Where does the including a single failure wording come from?

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

23. RIS Attachment 2nd bullet, with respect to the text including the statement: Please clarify the intent of the use of the Page 4, Section For digital modifications, particularly those that introduce software term software in this section based on the 2.2, Step 2 What is this intended to mean? comment.

- Consider how digital modifications that do not involve software should be defined, as most digital equipment has software/firmware.

Examples are discrete logic chips and FPGAs. Please consider the use of the term

- Introduce software phrase could be taken that this only applies to redundant and independent versus just the analog to digital mods. It should also address digital to digital mods use of redundant.

- The use of redundant should also have independence stated. Please change to redundant and independent. This is a generic comment wherever redundancy is used. Independence is the key word.

Redundancy can be added in non-safety systems for reliability purposes only.

24. RIS Attachment This statement, although out of NEI 01-01, would seem to imply that digital Add supporting statement(s) that include Page 4,Step 2 upgrades will always increase the likelihood of failure, which has not been acknowledgement of positive, not just Section observed in actual practice where, in most cases, digital upgrades have negative, impacts of installing digital been shown to decrease failure likelihood. equipment.

Also, in 50.59 it is common practice to consider the balancing of positive effects of installing the digital equipment (e.g., elimination of SPVs, signal Further, rephrase the statements that imply validation, etc.) with the potential negative effects (e.g., SCCF, etc.) when that digital systems will always increase the arriving at the final conclusion of not more than a minimal increase in likelihood of failure to include the idea of no malfunction likelihood or accident frequency. The RIS does not appear to more than a minimal increase text from discuss using the balancing effects of the positives and negatives of digital 50.59.

upgrades.

25. RIS Attachment / Bullets contain quoted guidance from NEI 01-01 and NEI 96-07, Rev 1; Revise the last three bullets to ensure Page 4, Section however, the quoted text from the last three bullets could not be traced back quoted information is accurate and traceable 2.2, Step 2 to either source. to the source document.

Provide a reference to the source.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

26. RIS Attachment The title of this section is Draft Characteristics of Proposed Modifications Clarify the applicability of the characteristics Page 5, Section 3 that Produce Effective Qualitative Assessments. The first paragraph of this in this section to digital modifications.

section states: Consider changing Do not to:

Do not create an adverse condition due The NRC staff finds that proposed digital I&C upgrades and modifications to having all the characteristics listed below are more suitable to and effective for qualitative assessments and thus more likely to meet the 10 CFR 50.59 evaluation criteria. Remove that Produce Effective Qualitative Assessments from the title and delete more The title and wording in this section imply that the Qualitative Assessment suitable to and effective for qualitative Framework is permitted only for digital modifications having all the assessments and thus from the last characteristics in this section. sentence of the first paragraph to avoid misinterpretation of this section.

It is assumed that the term effective actually means produces positive results. The section reads more clearly without the word effective.

27. RIS Attachment This sub-section states Digital I&C design function-for-design function Unless the phrase design function-for-Page 5, Section 3 replacements and upgrades to systems and components that: Is the design function provides additional criteria (1) qualifier design function-for-design function both meaningful and or meaning, it is suggested that it be removed.

necessary?

If the term provides specific meaning, please provide the criteria for determining the function for function alignment.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

28. RIS Attachment This section seems to constrain the digital modification to a very limited Clarify the applicability and limitations of Page 5, Section 3 scope, which does not appear to meet the intent. For instance, it is not clear these constraints to address potential issues whether all of the attributes, or some of the constraints need to be met. with items noted, such as:

Applying these in a strict way would eliminate most digital changes being - DCS Upgrades contemplated, or currently being done. For example: - Safety Chillers

a. 1a)-b) These conditions appear to only allow designs that dont - Embedded Devices combine functions that were previously separate (this eliminates DCSs from being considered per this criteria, even if you use segmentation on separate controllers because they communicate via shared network, which is not acceptable).
b. 2 could be construed to eliminate all safety systems that have two channels (chillers) from consideration since they will be digital and identical and this will screen them out before we even get a chance to demonstrate low likelihood of CCF.
c. 3 is just a regurgitation of BTP 7-19 criteria, but the prelude to the section says that all criteria must be met, which is pretty much impossible for embedded devices.
29. RIS Attachment The exclusion of systems using common HMI eliminates all non-safety The type of systems that use shared Page 5, Section 3 related DCS upgrades from this RIS scope. resources should be in scope of this RIS 1(a) & 1(b) which should describe that the licensee addresses combination of functions and spurious operation in the qualitative assessment.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

30. RIS Attachment With respect to the text including the statement: The RIS should clearly define the scope of Page 5, 1st the qualitative assessment results alone are sufficient that software CCF CCFs (software, etc.) being considered.

paragraph does not need to be assumed The use of software CCF appears to limit the use of qualitative methods to demonstrate that CCF does not have to be assumed for other types of potential common cause failures.

31. RIS Attachment With respect to the text including the statement: Clarify whether the different result is at the Page 5, Step 3 SSC level or plant level. The industry position is that the results are evaluated at Only for possible malfunctions that do not have a sufficiently low likelihood the plant level, as discussed in the recent based on the qualitative assessment in Step 2, determine whether the RIS public meeting.

malfunction has a different result.

32. RIS Attachment With respect to the text including the statement: Remove implicitly assumed.

Page 5, 1(b) Do not incorporate new shared resources..... implicitly assumed Implicit assumptions are impossible to verify. Should provide clarification on whether system function equals design function and if so, use design function.

33. RIS Attachment With respect to the text including the statement: Please reword with reasonable assurance Page 6, Section 3 .that do not result in reduction of any aspects of independence language instead of using do not.

(2) This goes beyond reasonable assurance. Adding any software could and does result in a small quantitatively reduction.

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34. RIS Attachment With respect to the text including the statement: Eliminate the 100% testing criteria as the Page 6, item (3) as demonstrated through 100% testing only test for simplicity.

There is a lack of clarity with industry (and perhaps regional inspectors) over what constitutes 100% testing, and this simplicity concept. Technical individuals working on the NEI/Industry DI&C teams have come to understand that any device containing software is not considered to be 100% testable, and we must assume a CCF.

If this is the case, then this RIS will only work for a very limited number of digital changes.

The 100% testing approach does not meet the qualitative intent of the RIS, and the reasonable assurance standard.

35. RIS Attachment With respect to the text including the statement: Address the use of the term bounding with Page 6, item (3) bounded by previous FSAR analysis.. respect to plant level in this section, and further define FSAR analysis as safety analyses
36. RIS Attachment With respect to the text including the statement: Add a discussion and clarify methods for Page 6, 4th demonstration that the resulting replacement or upgrade design can demonstrating what would be an acceptable paragraph tolerate the postulated triggering of that defect way of tolerating the triggering of a defect.

This statement would seem to indicate that we must assume a design defect and then assume the design defect is triggered. If this is the intent, Clarify the statement to indicate whether a the RIS will likely not work for most safety related SSCs (including the design defect must be assumed or not.

safety related chiller mod). If this is not the intent, should clarify the statement. Define the basis for the design defect likelihood needing to be significantly lower.

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37. RIS Attachment With respect to the text including the statement: Add a clear language in this paragraph that Page 6 last Alternatively, electrical independence can be demonstrated qualitatively states, software also can be addressed in a paragraph The real purpose of this RIS is software and SCCF with respect to qualitative manner and consider using a Page 7, first independence. digital example.

paragraph Using electrical independence may not be the best example for this RIS.

38. RIS Attachment / A new term, layers of defense is used and is not defined. If this is intended Either define the term layers of defense or Page 7, Section to refer to defense in depth, then defense in depth should be stated. use the term defense in depth.

4.2 Alternatively, provide a reference to the USNRC or industry document being used to define layers of defense.

39. RIS Attachment With respect to the paragraph beginning with: Clarify this section to acknowledge a Page 8, Quality For digital equipment incorporating software.. different standard applies for non-safety Design Process These attributes may not be available or well documented for non-safety related upgrades.

related equipment that contains software. NEI 01-01 was primarily written to evaluate changes to safety related SSCs. Quoting this paragraph within the RIS may lead some (including regional inspectors) to believe that all these attributes must be accounted for when implementing a non-safety related digital upgrade with software involved.

40. RIS Attachment With respect to the text including the statement: Please clarify the intent of this statement.

Page 8, Last .thoroughly documented within the licensees quality assurance (QA) paragraph program..

What is specifically meant by ... documented within the licensees QA program? Does this mean a formal qualitative assessment document must be developed and placed within the engineering change package for future retrieval?

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

41. RIS Attachment In section 4.2 the last paragraph on page 8 says All of these categories Please clarify intent of QA program Page 8, Last should be addressed and thoroughly addressed in the licensees quality reference.

paragraph assurance program, in consideration of the safety significance of SSCs Clarify QA program applicability is not based described below in Section 4.2 (See table 1) There may be confusion on safety significance of SSCs, but on the about what this means.to be described in the QA program. licensees Quality Assurance Program.

42. RIS Attachment Please add endorsed EPRI TR-106439 as an acceptable example for digital Please add the reference as noted.

Page 8 commercial grade dedication mods.

Page 9, Table 1

43. RIS Attachment For Table 1, the list of acceptable examples, is this list intended to be Please clarify the applicability of the Table 1 addressed by each evaluation, or is this just a suggested list? For the examples cited in Table 1, and their design attributes, what is the expectation on behalf of the NRC that there be intended use.

all items, or some items? Is the determination of adequacy up to the licensee or will this list constitute the basis for a Mods or 50.59 inspection?

44. RIS Attachment / Environmental Qualification implies a Regulatory programmatic Revise environmental qualification to Page 9, Table 1 requirement; however, based on the subsequent examples, (e.g., EMI/RFI, demonstrated tolerance (e.g., through Seismic), this does not appear to be the context. qualification testing) to withstand environmental conditions within which the SSC is required to perform its design function (e.g., EMI/RFI, Seismic).
45. RIS Attachment Watchdog Timers - The RIS should not limit credit for external watchdog Suggest changing to Watchdog timers that Table 1 timers only. There are designs that have internal watchdog timers that operate independent of software or Design Attributes operate independent of the software and are considered just a reliable as something to that effect.

external watchdog timers (the digital reference adjuster used on the EDG voltage regulator project is an example of an independent internal watchdog An acceptable alternative might be timer). Watchdog timers that time out in hardware..

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

46. RIS Attachment Sufficiently simple and 100% testing are used here. See previous comments on this subject.

Table 1 Suggest acknowledging other types of Design Attributes testing to demonstrate the design is sufficiently simple, such as comprehensive, or exhaustive testing, versus just 100%

testing.

47. RIS Attachment Failure state always know to be Safe - An acceptable failure state could Revise to describe that the failure state of Table 1 also simply be equivalent to the failure state of the device being replaced, the new digital equipment can be the same Design Attributes not necessarily to the safe state. as the failure state of the existing equipment (whether or not the failure state is considered safe).
48. RIS Attachment The last bullet indicates that high volume commercial products are less Augment the discussion to suggest that Table 1 likely to have deficiencies. High volume, high quality commercial Operating products with applicable operating history Experience used in other applications have the potential to not include as many design errors.
49. RIS Attachment This paragraph does not clearly distinguish between safety related and non- Please clarify applicable scope for digital Page 10, 4.2.1.1 safety related SSCs. Digital communications (ISG-04) is a concern primarily communications criteria, to clearly specify with Safety Systems and is not applicable to non-safety systems. Though that ISG-04 is applicable to only safety there is very good guidance in ISG-04, this section seems to make it related modifications.

required to be addressed for all classes of systems that might be evaluated by this process. Would digital communication between non-safety SSCs Please clarify to address how this might be considered out-of-scope of this RIS? For example, a plant may have two applied to non-safety related examples.

(redundant) feedwater pumps - not for plant safety but for operational convenience. Would digital communication between the two feedwater Also, while ISG-04 is good guidance, and pump controllers be out-of-scope for this RIS? has been in place for more than a decade, it would be preferable to refer to more durable guidance.

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50. RIS Attachment For section 4.2.1.2 the gist of this section is that combination is bad in all Revise to acknowledge cases where Page 10, 4.2.1.2 cases, however, there are cases where combination of previously separate combination of functions may result in a components results in a more dependable system due to the tightly coupled more reliable and safer system.

nature and a reduction in complexity. A good example is the combination of Main Feed regulating valves with Feed bypass valves into one controller, this has allowed the industry to use one controller to control steam generator level through all power levels, where previously there was a manual cross over at a low power that often resulted in spurious level changes and plant trips due to loss of level control, those types of plant upsets are much less frequent with a combined system where both valves are controlled by one controller. A plant transient from both a bypass and MFRV may not be evaluated in the License but if the overall result from combining the two is a marked increase in dependability, in the aggregate.

51. RIS Attachment With respect to the discussion on combination of functions: Please add language that allows Page 10, 4.2.1.2, This section should acknowledge that combination of functions is allowable combination of functions where it does not 3rd sentence where it does not create an adverse condition; the 3rd sentence does not create an adverse condition.

accurately reflect verbiage consistent with 10 CFR 50.59.

52. RIS Attachment / The phrase the other NRC-approved processes does not provide If the other NRC-approved processes is Page 10, 4.2.1.2, guidance. intended to be license amendment request, last sentence so state. Else, define all the other processes that could be followed.
53. RIS Attachment This section should include reference of EPRI TR-106439 as an acceptable Add the noted reference.

Page 10, 4.2.2 example for digital commercial grade dedication mods.

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INDUSTRY COMMENTS ON DRAFT-RIS-17-xx, SUPPLEMENT TO RIS 2002-22 Attachment 2 - Clarifications Comment No. Section/Page # Industry Comment Recommended Change

54. RIS Attachment There is no expanded discussion on the Operating Experience topic. Revise document to use Section 4.2.3 as an Page 11 Sections 4.2.1 and 4.2.2 expand on the other bullet points noted on Page expanded discussion on Operating 7 and Page 8 of the attachment (Design Attributes and Quality Design Experience. Move current Section 4.2.3 Process). content to another section of the document.
55. RIS Attachment Quality Standards - please clarify the use of the term quality standards in Clarify the use of the term quality Page 11, 1st the RIS. If the intent is to define a high quality design process, then the standards.

paragraph licensee Appendix B program should govern the activities as applicable.

It should be noted that there is no requirement for mandatory use of any other type of quality standard for non-safety related applications.

56. RIS Attachment It appears that the YES/NO labels should be reversed on the diamond near Flip the YES / NO labels.

Figure 1 the top of the page which states Does the proposed change have the characteristics described in the attachment to the RIS? Suggest being more specific by adding a Also, the first box appears to be selecting criteria. That is, if the specific section number of the RIS that characteristics dont match (e.g. no combinations, no communications, etc.) details the characteristics. (RIS Section 3?)

they you cant use this process. If you exit the RIS 2017-xx process, then are on your own to use NEI 01-01 as originally endorsed in RIS 2002-22? Consider an exit to this process that shows the previous RIS/NEI 01-01 process.

57. RIS Attachment The flowchart only addresses 50.59 Evaluations Questions 2 and 6. Suggest addressing Questions 1 and 5.

Figure 1 Questions 1 and 5 do not appear to be addressed in the flowchart.

58. RIS Attachment Conduct the Technical Analysis and Assess Vulnerabilities is split into two Provide explanation as to why this process Figure 1 boxes, but in reality the vulnerabilities will be assessed in the design is split into 2 boxes, and/or update Figure 1.

change (in the box that feed into the Conduct Technical Analysis). Is this split into two boxes because the RIS expect two distinct documents? Or do both of the boxes constitute the single Qualitative assessment as outlined in Table 2. The assumption is that it is broken out based on some thought model held by the staff, but in actuality this is all done under the design change process and is only documented in the 50.59 as a high level summary with sufficient detail to assist the approver of the 50.59 (and to support the NRC review under Mods inspections).

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59. RIS Attachment This section appears to be written for safety-related software. In most Update this section to reflect the level of Page 13, Section cases, the evidence required in Section 5.1 would be difficult to compile for documentation that might be typically seen 5.1 non-safety software containing COTS devices. for non-safety related upgrades.

Augment the software safety analysis to software safety analysis (as applicable) to capture the non-safety related equipment.

60. RIS Attachment In Section 5.1 there is a statement that says that the Qualitative Revise document to address the software Page 13, Section Assessment should provide evidence that a well-defined process for - and process typically seen for non-safety related 5.1 it continues on with a statement of components from BTP 7-14, which again and commercially dedicated equipment.

is only applicable to safety-related software and would also be germane (but not required) for non-safety related software. What if any concessions are allowed for those non-safety and even those components that are Commercially dedicated where we will often credit extensive operating history and testing along with largely equivalent software processes, where portions of the software lifecycle are less relevant and not needed to make the Qualitative Assessment for less risk significant system that screen into 50.59 evaluation? See comment below on section 5.2 19

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61. RIS Attachment In Section 5.2 there appears to be a hint of grading by safety significance, Please clarify basis and applicability of Page 13, Section which is in keeping with the original NEI 01-01, but the two lists are not well these grading criteria.

5.2 defined, are you saying that the items on the list constitute a risk significant system? Are they in any order of risk significance, or are they all considered equally risk significant? With the contrary being deemed less risk significant and therefore less documentation required and the second list seems to have a function based criteria. Same question as above, (all risk significant; any sort of hierarchy implied?). Will this grading be up to the utility? Or will this RIS address which would be acceptable?

62. RIS Attachment 2nd bullet - With respect to the term accident mitigation system Suggest clarifying by stating ... accident Page 13,Section Is this statement referring to accident mitigation systems that are credited in mitigation system credited in the safety 5.2 the safety (or accident) analysis? There are some non-safety systems that analysis.

can be used for accident mitigation but are not credited in the safety (accident) analysis (e.g., off-site power is the preferred source of power for mitigating accidents but is not generally credited as an accident mitigator in the safety (accident) analysis). There is some confusion in the industry when it comes to defining a SSCs that are considered accident mitigators.

63. RIS Attachment With respect to the following statement: Request this section be clarified to Page 14, last It is the responsibility of the licensees 10 CFR 50.59 evaluator to differentiate between where design basis paragraph demonstrate that the documentation of the design basis information is documented (for instance, the plant modification process), versus where licensing basis information is documented (for instance in the 50.59 evaluation).

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64. RIS Attachment Step 1, last bullet: Add clarification as described in comment.

Table 2 Please add clarification that the evaluation should consider both active and inactive states.

65. RIS Attachment Step 1, 3rd bullet - Safety and power generation functions. Please clarify what this statement is asking Table 2 for, it is not entirely clear.
66. RIS Attachment Step 3 - Enhanced Safety Analysis. Please define or clarify what enhanced is Table 2 referring to.
67. RIS Attachment Step 3 - Failure Modes. Please add a note stating that the failure Table 2 mechanisms can change. Please add a note allowing us to eliminate failure modes of the original equipment in the replacement equipment.
68. RIS Attachment Step 4 - last paragraph, beginning with All assertions If this is the case, please explain. If this is Table 2 This statement implies that the licensee must assume a CCF. not the case, please reword or provide clarification.
69. RIS Attachment In Table 2: Steps 4 and 6 seem to be repeats, you make the assertions and Leave one or the other out, the evidence Table 2 provide the evidence, then repeat the assertions. needs to support the assertions either way.

If not repeats, but rather two steps in a process, where identification is done Clarify why the two steps are provided.

in one step, and verification of resolution is provided in a separate process, then suggest clarification.

70. RIS Attachment Step 5, 2nd paragraph, vectors to malfunctions. If definition exists, please provide it; Table 2 otherwise recommend deletion.

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71. RIS Attachment Step 5, first paragraph, evidence of the three qualitative assessment Please provide a reference to an earlier Table 2 justifications. section in the RIS or RIS Attachment where the three qualitative assessment justifications are provided for completeness.

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