ML20196K328

Forwards Encl Documents to Be Placed in PDR Per Commissioner Mcgaffigan

ML20196K328
Person / Time
Issue date:	07/06/1999
From:	Bridgers M NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9907080284
Download: ML20196K328 (6)

Text

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July 6,1999 j

NOTE TO:

Document Control Desk Pu lic Document Room FROM:

argo B gers, OEDO

SUBJECT:

DOCUMENT FOR THE PDR l

The attached documents should be placed in the PDR at the request of Commissioner McGaffigan.

Attachments:

1. 6/16/99 AO Memo to Comm. Assts. encl.

Staff Response to 6/10/99 NEl 10 CFR' 50.59 Letter

2. 6/21/99 EDO Memo to Comm. - Staff Views concerning 4/30/99 Letter from the NEl Concerning 50.59 08003g 9907000284 990706 PDR COMMS NRCC CORRESPONDENCE PDR

e a nag UNITED STATES p

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NUCLEAR REGULATORY COMMISSION 2

WASHINGTON, D.C. 20666 4 001

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.i June 16,1999 NOTE TO COMMISSIONER ASSISTANTS OCWSJ OCM/GJD OCM/ND L Mike Weber

& BradJones

& Maria Lopez-Otin

_ Brian Holian

_ Terence Chan

_ Roger Davis

_ JamesJohnson

_ Joel Lubenau

_ Tony Hsia

_ Karla Smith

_ Keith McDaniel

_ Pat Castleman

_ Regis Boyle

_ Tom Boyce

_ John Lubinski

_ Clare Kasputys

_ Donna Smith

_ Vicki Bolling

_ Dan Gillen

_ NobelGreen

_ Libby Perch Steve Cahill

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_ Jim Smith OCM/EM OCM/JM I

_ Laban Coblentz I

_ Mark Miller

& Steve Crockett

& Lynne Stauss

_ Evelyn Williams

_ Janet Schlueter

_ Margle Doane

_ Gladys Ordaz

.. James Beall

_ Brian McCabe

_ Judy Ledbetter

_ Jeffry Sharkey

_ John Thoma

_ Leslie Hill

_ Cathy Grimes

_ Lorna Pini

_ Frances Marek

_ Linda Lewis

_ Tojuana Fortune f

FROM:

James L. Blaha M

Assistant for Oper tions, OEDO

SUBJECT:

STAFF RESPONSE TO JUNE 10,1999 NEl 10 CFR 50.59 LETTER

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In anticipation of staff receipt of the subject letter, the attachment provides initial staff views on this matter.

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Attachment:

As stated cc: W. Travers, EDO (w/o attachment)

SECY (w/ attachment)

M. Knapp, DEDE (w/o attachment)

OGC (w/ attachment)

F. Miraglia, DEDR (w/ attachment)

OCA (w/o attachment)

P. Norry, DEDM (w/o attachment)

OPA (w/o attachment)

J. Blaha, AO (w/ attachment)

EDO R/F (w/ attachment)

G.Tracy, OEDO (w/ attachment)

Public M. Satorius, OEDO (w/ attachment)

D. Matthews, NRR (w/o attachment)

E. McKenna, NRR (w/ attachment)

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STAFF COMMENTS CONCERNING JUNE 10,1999, NEl LETTER ON 10 CFR 50.59 FINAL RULE STATEMENT OF CONSIDERATIONS NOTE: Comments are summarized below - refer to June 10 letter (attached) for complete text.

Item 1:

NEl recommends inclusion of "as described in FSAR (as updated)" in criterion (vii) for consistency.

Comment:

Staff does not object to this proposal.

item 2:

NEl recommends revision of $50.59(c)(4) to state: "The provisions of this section do not apply to changes to the facility or the procedures when the applicable regulations establish more specific criteria for accomplishing such changes."

Comments:

Emergency response facilities and procedures are included as part of the emergency e

plans subject to $50.54(q); however, to the extent that such facilities are also described in the FSAR, there is overlap of requirements. The intent of the rule revision was to eliminate duplicative requirements, such that if a 50.54(q) evaluatt..umently addresses a change, a 50.59 evaluation is not also required just because there 5 a description in the FSAR. However, there may be certain changes where a licensee would need to address both the requirements of 50.54(q) and 50.59 based upon the potential interrelationships between the emergency response facilities and the SSC described in the FSAR. Such cases may need to be reviewed as two changes, one under 50.59 and one under 50.54(q).

Safeguhrd plans are controlled by $50.54(p). The staff believes it unlikely that securit barriers are described in the FSAR, because the plans are not part of the FSAR, and because such information may be Safeguards Information, but if such descriptions are part of the FSAR, this is another area of possible overlap.

The staff agrees that the $50.46(a)(3)(iii) change process applies to changes to "an acceptable evaluation model or in the application of such a model," however, physical changes in the ECCS system, as described in the FSAR, continue to require a $50.59 evaluation.

With respect to changes to the facility that affect parameters govemed by TS, the staff does not understand the concern. The purpose of the $50.59 process is to determine whether NRC prior approval is required for a change, test, or experiment (and to document the basis if such approval is not sought). Part of the process is a determination as to whether a TS change is involved. If a facility change involves a TS, prior NRC approval of the change is required pursuant to (existing) $50.59(a)(1). A rule change is not needed to state that when a TS change is needed, a licensee does not need to perform an evaluation against the criteria in (newly numbered) $50.59(c)(2).

(Existing inspection guidance in IP37001 already discusses this point.)

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.- in summary, the staff did not find that it was necessary to include this rule change.

e However, the staff would not object to inclusion of the sugges'ted rule language provided clarification as noted above is included in the implementing guldance.

Item 3:

NEl states that methods of evaluation for time-limited aging analyses and aging management programs pursuant to Part 54 should not be subject to criterion (vili) because they do not establish new design bases or constitute new safety analyses. NEl also disagrees that there is a need for supplemental 50.59 implementation guidance for Part 54.

Comments.

The final rule on license renewal requires that a summary description of the programs and activities for managing the effects of aging or evaluation of time-limited aging analyses for SSC be placed in a FSAR supplement. As stated in the soc, this revision was vede to reflect such that existing regulatory processes are sufficient to enstre that cheer to rograms or TLAA will receive appropriate review by the licensee. The soc further kated that " subsequent changes are controlled by 50.59."

As part of the rule change, a definition of " facility" was provided. The major point of the e

discussion about license renewal is that these programs and analyses in the FSAR supplement fall within the definition and therefore, changes are subject to the evaluation criteria. if there are no evaluation methods involved, the other 7 evaluation criteria would apply to changes to the analyses or programs.

The final rule package notes that evaluation methods are subject to criterion (viii) to the e

extent that tney are described in the FSAR supplement. The staff views the TLAA or aging management programs as falling within the definition of " design bases or safety analyses" in that they provide the basis for ensuring that SSC remain functional when considering the period of extended operation. Thus,if there are evaluation methods described, evaluation against criterion (viii) would be required. If there is no particular methodology associated with the FSAR supplement description for a TLAA or an aging management program, criterion (viii) would not apply.

With respect to guidance, the staff would accept that specific guidance may not be needed for Part 54 for 650.59 purposes (so this specific statement could be deleted if '

desired), but also thinks that guidance might wel; be necessary for purposes of l

establishing what information is needed in the FSAR supplement. Also, the 50.59 implementation guidance development process would benefit from the inclusion in the CoC of a specific example related to a change involving Part 54.

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in summary, the staff believes that this information is subject to 650.59 rule requirements, including criterion (viii), as noted above. Thereforn, the staff recommends l

j that the soc continue to discuss license renewal as currently drafted.

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b4 Item 4:

NEl states that the example which attempts to illustrate that Class 2 piping is l

part of RCS pressure boundary is incorrect. Further the EpCS alignments can be isolated from the RCS pressure boundary and are not fission product barriers.

Finally, Code Class 2/3 requirements are covered by QA plan commitments and would be subject to $50.54(a).

Comments:

- The staff's intent is to ensure that Class 2/3 piping is maintained within the Code levels (unless there is staff review of any proposed exception). NEl agrees with this position.

The staff agrees that the example (if retained) should be clarified to note that Class 2 e

piping is not part of the RCS pressure boundary as it is defined. Class 2 piping in systems such as the ECCS can be the fission product barrier for coolant under post-accident conditions, and as such is within the scope of criterion (vii). The staff disagrees with the comment that some Class 2 piping is not a fission product barrier to the extent that, for accident situations, it may not be feasible to isolate such piping from the RCS and the piping would contain contaminated coolant.

if commitments to ASME code requirements are included in OA plans, then the e

$50.54(a) process would govern any changes to those commitments.

in the April 30,1999, NEl letter, NEl proposed guidance for minimal increases in e

probability that would state that exceeding Code levels is beyond " minimal." The staff agrees with this position.

in summary, based on these factors, the staff supports a revision to the soc to remove e

the criterion (vil) example about Class 2/3 piping and to provide alternative discussion concerning treatment of Class 2/3 piping as an example of a more than minimal i -

Increase in likelihood of malfunction along the lines noted above.

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l item 5:

NEl states that the example on NPSH as representing a departure from a method of evaluation is irrelevant because ECCS performance is addressed by

$50.46. Also, containment overpressure would seem to be an input rather than part of the method. Finally, NPSH is part of the detailed design, not " design bases or safety analyses" and thus is not within scope of criterion (viii).

Therefore, this example should be deleted.

Comments:

The point of the example was to illustrate the types of elements of evaluation methods e

that the staff views as falling within this criterion. While the staff agrees that containment pressure is a physical parameter, the calculated amount under accident conditions, and the suitability of taking credit for it as part of the NPSH calculation, and is one of the l

fundamental assumptions of the methodology that is described in the FSAR. This was

'i the staff position discussed at the March 10 meeting. Crediting more overpressure than j

previously evaluated is a nonconservative change.

3.

Further, the analyses of adequacy of NPSH with respect to demonstrating that ECCS e

pumps are capable of delivering specific flows under accident conditions are not covered by the evaluation methods reviewed by NRC as part of $50.46 and Appendix K. This example would not have been o#ered had the issue been within the scope of $50.46.

Until the licensee determines that the pump flow is degraded as a result of insufficient NPSH, the $50.46 analysis would be unaffected by the NPSH s'nalysis.

The staff views demonstration of pump capability under the set of conditions that for e

which it is required to function as part of the design bases, and therefore that NPSH falls within the definition of criterion (viii). As noted during the March 10 meeting, if there is potential for pump cavitation as a result of insufficient NPSH, this could also satisfy the more than minimal increase in likelihood of malfunction criterion.

in summary, the staff believes that this is a representative example of a change that e

illustrates the relationship between input parameters and methods, where there is a departure from the method described, and therefore, of a change that would not satisfy criterion (viii). The staff therefore recommends its retention in the soc.

item 6: Text on page 77 - NEl notes that a sentence was omitted from the rule text in the discussion on this page.

Comment:

This is an editorial correction to the Statement of. Consideration discussion that *-

the staff agrees with (the rule language on p.136 is correct).

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NUCtfAt [NitGf INSil!UIE Reich E. s a.

June 10.1999 The Honorable Shirley Ann Jackann Chairman U.S. Nuclear Regulatory Commisnian Washington.DC 20555

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SUBJECT:

10 CFR 50.59. Final Rule and Statementa of umsideration

Dear Chairman.!nckson:

in SECY 99130. the NitC staff requested Comminaion upproval to publish a final rule that willrevise 10 CFR 50.59 and related requirements. We commend the staff for the thorough. comprehensive. and fair treatment of all comments and issues dincunaed in the final rule package. We believe the proposed final rule will significantly improve the clarity and stabdity of the rt:gulation na wc!! as the conduct of heensee evaluutions.

In nur communientions with the stuff durmg development of the fmal rule package, we stressed the importance of the clarity of the rule language and Statements of Consideration (SOC) to assure that the new rule in properly interpreted. In reviewing the SOC. we have found wome statements that are misleading nr beyond the intent of the rule. To avoid implementation difficulties, these statementa abould be omitted from the final rule. These statements and nur recommendatinna nre discussed in the encinnure. We also recommend two minor clarifications to the proposed rule language.

The development ofimplementation fluidance is also important to the overall effort. Our task force on 10 CFit 50.59 has already begun drafting a revision to NE106-07 to comport, with the new rule. We Innk forward to discussing the draft with the staff. ACRS und Commission in seeking NitC cndorst ment in a regulatory guide.

Plenac call me if you have any questions regarding the suggested modifications in the enclosure.

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h Honornble Shirley Aan Jackson June 10,1999 Psyc 2 i

The Emorable Greta Joy Dieus, Commissioner, NRC c.

h lionorable Nils J. Diaz. Commissioner, NRC The Honorable Edward McGamgan, Jr., Commissioner, NRC The Honorable Jeffrey S. Merrifield, Commissioner, NRC Dr. William D. Travera, NRC/EDO

'Mr. Samuel L. Collins. NRC/NRR l

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i Suggested Modifications to 10 CFR 50.59 Final. Rule and Staternents of Consideration Rule lanmanne darifhtions

1. At the NEI workshop on June 3 4, a licensee questioned why the scope modifier

'as described in the FSAR (as updated)*' (or equivalent) is included in all of the proposed evaluation criteria except 10 CFR 50.59 (c)(2)(vii). It appeared to the questiondr that the staffintended a different, perhaps broader, scope of review concerning design basis limits for fission product barriers. The staff responded that no different scope of review was intended; that the mining modifier was implicit in the criterion and not needed. Because including the modifier in thin criterion would make it consistent with the other seven, is consistent with the NRC staffintent, and muy avoid future confusion, we recommend that 10 CFR 50.59 (c)(2)(vii) he rewritten as follows:

(c)(2)(vii) Result in a design basis limit for a fission product, barrier ax described in the FSAR (as uudated) heing exceeded or altered.

2. We do not understand the staff reluctance to clearly state in the rule that changes to the facility-as well as procedures-that are governed by other aquirements and criteria may in excluded from evaluation under 10 CFR 50.59.

Injustifying why changes to the facility were not included in 10 CFR 50.59(c)(4)

. as recommended in item I.7 of our December 21,1998, comments on the proposed rule, the staff said that they could not identify any types of changes to the facility that were controlled by other regulations. However, we believe changes to accurity barriers or emergency response facilities described or depicted in the UFSAR fit this category. Such changes would be co'ntrolled under 10 CFR 50.54(p) or (q), and duplicative evaluation under 10 CFR 50.50 is not required.

I Moreover, absent the recommended clarification, the rule would not make clear that changes to L.hc facility (which includes SSCs, design and performance requirementti and associated evaluations) that affect parameters governed by the technical specifications,10 CFR 50.46, or other requirement do not also require evaluation under 10 CFR 50.59.

We are not aware of any disagreement that changes-whether to the facility or j

procedures-that ure controlled by other, more specific regulations are governed by the more specific regulation, not 10 CFR 50.59. Accordingly, paragraph (c)(4)

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uf the final rule xhould he modified as follows:

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l (c)(4) The provisiona of this noction do not apply to changes to t.hc facility or pmcedures when ths applicable regulations establish more specific criteria for accomplishing such changes.

Cc==enus and recommendations on the Statements of Consideration

3. Pg. 68 1n discussing the applicability of new criterion (viii) on methods of evaluation, the SOC included the following statement:

in addition, the Commissiors notes that changes to time limited aging analyses and evaluations of aging, management programs required by 54.21(d) and 54.37(b), require evulaation with respect to criterion (viii) to the extent that evaluation methods for these analyses are described in the FSAR supplement.

Tius statement should be deleted from the SOC.

We agree that supplemental UFSAR information required by 54.21(d) and

. 54.37(b) may include " evaluations that demonstrate that intended functions will be accomplished" that are within the meaning of" facility" and therefore would be subject to 10 CFR 50.50.

However, changes to evaluations of aging management programs would not be subject to 10 CFR 50.59 (c)(2)(viii) because the required supplemental FSAR information does not establish new design bases or constitute new safety analyses.

We are especially concerned by the staff proposal (which was not discussed in the proposed rule or t.uhscquent interactions on the applicability of the new criteria) because it constitutes, at best, a lack of understanding of the new criterion. At worst, the proposal is an eleventh hour attempt to misuse t% new criterion to address the separate generic concern of the NRC staff-unrelated to 10 CFR 50.59-about control of aging management processes and activitica. At a time when the NRC is attempting to impose the first new 10 CFR 50.59 criteria in over 30 years, we must work together to communicate effectively about the focus and intent of the changen.

We also disagree with the kiRC ataff statement on page 23 of the SOC that f

special 10 CFR 50.59 implementation guidance is necessary with respect to Part

54. The nature of supplemental UFSAR information added for license renewal is no differcut than pec existing UFSAR information, therefore no Part 54.epecific

. guidance is necessary.

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c 4a.Pg. 84 Exampic 4 This example uttempts to illustrate the application of criterion 10 CFR 50.59 (c)(2)(vii) on changes affecting a design basis limit of a fission product barrier (in this caso, the RCS pressure houndary).$ However.

ASME Code Clam 2 piping is not part of the RCS presure boundary. This example is incornwet and abould he deleted fmm the SOC.

In a public moeting with the NRC staff on March 10, we discussed that (c)(2)(vii) would not apply in this case. Rather, the determinant crikrion would more likely he tha't for likelihood of malfunction, (c)(2)(ii). Because applicable design and quality standards were not followed, the change involves more than a minimalincrease in the likelihood of malfunction, and prior NRC approval would be required, ma discussed on page 37 of the SOC.

i Subsequent to the March 10 meeting, we learned that for plants where ASME Code Class 2/3 rules are not zequirements, licensecs have QA Plan commitments to follow the Code requirements. A reduction in this commitment would require prior NRC approval under 10 CFR 50.54(a) and would not be subject to 10 CFR 50.59.

Whether a licenace determines that this type of change requires prior NRC approval based on 10 CFR 50.59 (c)(2)(ii) or 10 CFR 50.54(a), it is clear that 10 CFR 50.59 (c)(2)(vii) does not apply.

4b. Consistent with elimination of Exampic 4, the parenthetical statements below on l

page 10 CFR 50.59 of tiic SOC are inappropriate and should also be deleted u indicated.

Forpower sactors, these barriers are generally limited to the fuel cladding, the RCS pressure boundary (!=:!::d!=g pi;d :==d ECCS :!!;n===t:), and containment. (% ECCS =!!;==t: ::: th=== ::=fi;u:::i: : cf:=;ine:::d erf: yl::h=:: q::!;. :=? %! f::= th: RCS;::::::: b::: d::y.=d: d::ign 5::* :::!!:=l =!!!;;=!!= ::::= :::.)

The ECCS alignments referred to are generally ASME Code Class 2 and 3 piping, can be isolated from the RCS pressure boundary, and are not part of the fasvion product barrier.

5. Pg. 71 - Example 4 This example attempts to illustrate a departure from a method of evaluation based on the results of the analysis being nonconservative.

This example is not clear cut and is therefore not a good illustration or how 10

' CFR 50.59(c)(2)(viii) v.uld be applied. As such, it should be deleted from the SOC and discussion of thic. cxample deferred to the implementation guidance.

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As discuemed with the NRC staffin a meeting on March 10, containment overpressure would seem,on its face, to be an input to NPSH analysea-not a method ofevaluation nuhject to control under 10 CFR 50.59 (c)(2)(viii).

Secondly, changes in unabses of ECCS performanca could be viewed as governed by the acceptance critariatale CFR r:0.46, which takes precedence over 10 CFR 50.59 based on paragraph (4(4) of the proposed rule (see Comment 2 above).

Third, the example prejudges the outcome ofongoing interactions on the integretation of 10 CFR 50.2 design bases. We do not helieve that required NPSH is a design basis limit for the ECCS such that changes would be subject to i

criterion (c)(2)(viii). As we have discussed with the staff, minimum NPSH is part of the detailed design-i.e., how design requirements are met-not part of the ECCS design bases.

Luetly, it appeared at the March 10 meeting that the NRC staff has a technical concern with one or more licensees' ECCS analyses that it was necking to resolve through this rulemaking.

These factorsindicate that this example should not be included in the 500. If, in fact, the NRC staff has a specific concern with credit for containment overpressure in ECCS analyses, the staff should address the concern directly with licenseernot through changes to 10 CFR 50.50.

G. Page 77. The second sentence of 10 CFR 50.71(e) is missing from the indenfad paragraph.

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WASHINGTON, D.C. 20565 0001 June 21, 1999 c,

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MEMORANDUM TO: Chairman Jackson l

Commissioner Dieus l

Commissioner Diaz.

Commissioner McGaffigan Commissioner Merrifield i

FROM:

William D. Travers W

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Executive Director for Operations

SUBJECT:

STAFF VIEWS CONCERNING APRIL 30,1999, LETTER FROM THE I

NUCLEAR ENERGY INSTITUTE (NEI) CONCERNING 10 CFR 50.59 1

In a letter dated April 30,1999, (copy attached), the NEl provided a number of comrnents l

conceming the implementation of revisions to 10 CFR 50.59. In the paper forwarding the final l

rule to the Commission (SECY-99-130, dated May 12,1999), the staff stated that it would give its views on the NEl letter to the Commission. This mernorandum forwards these views.

l NEI's comments concerned five areas; the staff believesIhat the SECY paper adequately addresses three of these areas (design basis limits, increases in consequences above Standard Review Plan (SRP) criteria, and enforcement). Therefore, this memo focuses o'n the remaining two areas, guidance for minimal increases in frequency / likelihood and departure from a method of evaluation.

l Inthe attached tables, the staff has summarized the NEl's comments and presents staff reaction. In several of the areas, the staff believes that NEl's proposals have merit for inclusion in the guidance but further interaction would be beneficial to understand the proposals in deta!!. The staff further concludes that the statement of considerations as i

provided to the Commission does not require modification.

l Finally, the staff notes that in its letter, the NEl recommended implementation of the final rule a minimum of 6 months from the date of issuance of the final regulatory guide. The staff concludes that this schedule is comparable to the "18 months from publication" schedule l

recommended by the staff.

Attachments: As stated cc: SECY, OCA, OGC, OPA, CIO, CF0 CONTACT: E. McKenna, DRIP /RGEB 415-2189 L

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MEMORANDUM TO:Chairmin JIckson Commission 1r Dicus June 21, 1999 Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield FROM:

William D. Travers Executive Director for Operations s

s.;

SUBJECT:

STAFF VIEWS CONCERNING APRIL 30,1999, LETTER FROM THE NUCLEAR ENERGY INSTITUTE (NEI) CON'CERNING 10 CFR 50.59 in aletter dated April 30,1999 (copy attached), the NEl provided a number of comments concoming the implementation of revisions to 10 CFR 50.59. In the paper forwarding the final rule to the Commission (SECY-99130, dated May 12,1999), the staff stated that it would give its views on the NEl letter to the Commission. This memorandum forwards these views.

NEl's comments concemed five areas; the staff believes that the SECY paper adequately addresses three of these areas (design basis limits, increases in consequences above Standard Review Plan criteria, and enforcement). Therefore, this memo focuses on the remaining two areas, guidance for minimal increases in frequency / likelihood and departure from a method of evaluation.

In the attached tables, the staff has summarized the NEl's comments, and presents staff i

t reaction. In several of the areas, the staff believes that NEl's proposals have merit for inclusion in the guidance but further interaction would be beneficial to understand the proposals in detail.

The staff further concludes that the statement of considerations as provided to the Commission does not require modification.

Finally, the staff notes that in its letter, the NEl recommended implementation of the final rule a minimum of 6 months from the date of issuance of the final regulatory guide. The staff concludes that this schedule is comparable to the "18 months from publication" schedule recommended by the staff.

Attachment:

As stated cc: SECY, OCA, OGC, OPA, CIO, CFO CONTACT: E. McKenna, DRIP /RGEB 415-2189

• SEE PREVIOUS CONCURRENCE DOCUMENT NAME:G:\\ final \\nelmemo OFC DRIP:RGEB*

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DISTRIBUTION: M::mo to the Commission fm WTrcvtrs Dated June 21. 1999 Central File EDO R/F l f RGEB r# -

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• o NUCLE AR ENERGY INSitTUTE k,.

Anthony R. Pietrangelo

.EffE*nEou April 30,1999 Mr. David Matthews Director, Division of Regulatory Improvement Programs Office ofNuclear Reactor Regulation U.S. Nuclear Regulatory Commission Washington,DC 20555

DearMr.Matthews:

Over the last two months, NEI and NRC staff have participated in several public meetings to discuss the issues concerning the pending revisions to 10 CFR 50.59. We believe these meetings have been constructive and beneficial in gaining a clearer understanding of the intent and implementation impact of a revised rule. The purpose of this letter is to summarize industry views and comments on the principal topics of discussion.

1 The enclosure pmvides our comments on the following:

New criterion (c)(2)(vii) for controlling design basis limits of fission product barriers; New criterion (c)(2)(viii) for control of methods of evaluation described in the updated FSAR; Guidance for determining when a change involves a minimal increase in the frequency of an accident or likelihood of a malfunction; Further gtidance on minimal increase in consequences; and Enforcement guidance using the " substantial review" criterion.

Our objective throughout this activity has been to achieve stability and clarity in the rule and its hnplementation. Thus, it is critical that the rule, its statement of considerations, and the implementation guidance be consistent with one another. We urge the NRC staff to be explicit in describing the intent of the rule provisions in the statement of considerations. This is particularly important for the new criterion on evaluation methods. The enclosure provides several recommendations in this regard.

i 6()30-1776 8 5teff? NW 5Uiff aCO W A 5HINGT ON DC.

~O6 3708 PHONE 202 7'30 8000 f Au 202 785

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l Mr. David Matthews l

April 30,1999 l

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Wehave already begun th:1 process of developing conforming changes to the guidance provided in NEI 96-07. We expect to complete development of the revised guidance this summer and will request NRC endorsement in a regulatory guide. To allow licensees adequate time to effect program changes and train personnel, we recommend that the effective date of the rule be a minimum of six months from the date ofissuance of the final regulatory guide.

We look forward to future discussions with the NRC on the final rule and development of conforming changes to the implementation guidance. Ifyou have any questions concerning the enclosure, please contact me at 202-739-8081 or Russ Bell at 202-739-8087.

Sincerely, f-Anthony R. Pietrangelo RJB/ARP/ngs Enclosure I

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Enclosure Proposed New Criterion for Controlling Design Bhsis*,' Limits of Fission Product Barriers In a public meetingon March 31, the NRC staff proposed the following new 10 CFR 50.59 criterion for controlling design basis limits of fission product barriers:

(c)(2) Prior NRC approval required if the change, test or experiment would:

s (vii) result in a design basis limit for a fission product barrier being exceeded or altered.

We understand that the pbrase " design basis limit for a fission product barrier" would be defined in the statements of consideration for the final rule and implementing guidance as:

a limit established during the licensing review a.s presented in the-

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final safety analysis report for any parameter (s) use,d to determine the integrity of a barrier. The limit is the controlling value for the parameter at which confidence in the integrity of the barrier begins to decrease.

In our planned revision of NEI 96 07, we will identify that the parameters and limits that typically determine fission product barrier integrity are the followmg:

Fuel Claddine RCS Pressure Boundarv DNBR/MCPR Pressure e

Stresses **

Fuel temperature Fuelenthalpy Clad strain Containment Clad temperature

• Pressure Clad oxidation

• 4

• parameters / limits that are controlled by 10 CFR 50.46

• • parameters / limits governed by compliance with the ASME Code and technical specifications 1

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' New Criterion for Control of Methods of Evaluati n 9

Described in the Updated FSAE c.

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Backaround In public meetings on Manfh 31 and April 26, the NRO staff presented a revised proposal for a new criterion (c)(2)(viii) for 10 CFR 50.59 that would provide for control of changes to analysis methods described in the UFSAR. In a similar l

meeting on March 10, NEI agreed in principle that such a criterion was appropriate to include in the revised rule. The rationale for including the new criterion is based on the following:

Control of analysis methods presented in the UFSAR has been standard practice oflicensees based on industry guidance in NSAC-125 and its successor, NEI 96-071. It is reasonable to provide a regulatory basis for this historical licensee practice through a new criterion in 10 CFR 50.59 in light of the importance placed on methodology changes by both the industry and NRC.

Licensee control of methods has historically been 'part of evaluations of proposed changes with respect to the existing margin of safety criterion of 10 CFR 50.59.

The proposed replacement of this criterion with one focused solely on design basis limits for fission product barriers led the to NRC staff to conclude that an addit,ional criterion methodology was needed.

Industry and NRC review of several examples identified that certain types of methodology changes, e.g., changing from an NRC-approved code for transient analysis to an unapproved code, would not be explicitly limited by 10 CFR 50.59, absent the additional criterion.

Consistent with the Commission direction to provide flexibility in the revised rule criteria so that licensees can make " minimal" changes to the facility and procedures described in the UFSAR without prior NRC approval, and consistent with the staffs original proposalin SECY-99 054 to permit minimal cha'nges in a methods of analysis, it is important to provide such flexibility with respect to changes in methods of analysis.

8 Per longstanding industry guidance, changes in analytical methodology must be evaluated separately under 10 CFR 50.59 from proposed changes to the physical plant or procedures, be based on sound engineering practice, and meet all pertinent Quality Assurance Program requirements with respect to 10 l

CFR 50, Appendix B, Criterion ill, Design Control; V, Instructions, Procedures, and Drawings; cnd VI, Document Control. Changes in methods of analysis described in the FSAR (as updated), including their effects on analysis results are reported to NRC under 10 CFR 50.59 and reflected as appropriate in UFSAR updates under 10 CFR 50.71(e).

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NRC Proposal 4

The NRC staff has proposed to incorporate the following new cr.iterion and definition as part ofits pending revision of 10 CFR 50.59:

N 10 CFR 50.59(c)(2) Prior NRC approval is required if a change, test or experiment would:

- (viii) result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses.

Departure from a method of evaluation means (i) changing any of the elements of a method described in the FSAR (as updated)* unless the results of the revised method are conservative ** or essentially i

the same for the intended application, or (ii) changing from a method described in the FSAR (as updated) to another method -

unless that method has been approved by the NRC for the intended application.

Clarifications orovided by the NRC staff If there is a statement in the UFSAR that a particular method was used to perform an analysis subject to this criterion, that method of evaluation is considered to be a " method described in the FSAR (as updated)" regardless of whether there was further UFSAR discussion of the methodology or whether the referenced methodology was " incorporated by reference" in the UFSAR.

1

• • As used in Part 1 of this definition, " conservative" means that results using the revised method are closer to the applicable limit than the previous results.

We have the following comments on the scope of the new criterion, definitions, and associated guidance to be incorporated in the Statements of Consideration for the final rule and NEI 96 07.

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1. Lane of methods subiect to criterion (cifviii) f,

't in describing its proposal, the staffmoted that to be captured by new criterion

-(c)(viii), a method would have to meet two tests. First, the method must be described in the UFSAR. And second,it must be used to establish design bases or in the safety analyses. As discussedwith the staff, many design basis values are.eitiaer not derived analytically or are themselves inputs to analyses that may be adjusted within the constraints of the other seven criteria of 10 CFR 50.59.

Thus to minimize implementation issues, additional guidance is needed to focus the scope of criterion (c)(viii) on the analyses ofinterest.

Based on the discussion in April 26 public me +ing, there appears to be a common understanding on the scope of analy; ; subject to the new rule criterion. To capture this understanding and clearly focus the scope of criterion (c)(viii), it is important that the following additional guidance be included in the Statements of Consideration and NEI 96 07:.

i

. Methods of evaluation described in the UFSAR subject to criterion (c)(viii) are:

Methods of evaluation used in analyses that [lemonstrate that design basis limits of fission product barriers are not exceeded (i.e., for the j

parameters subject to criterion c(vii))

i

. Methods of evaluation usedin analyses that demonstrate that

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consequences of accidents do not exceed Part 100 or GDC limits (e.g.,

i Chapter 15 safety analyses)

Methods of evaluation, including codes and standards, approved by the NRC for use in analyses performed per NRC requirement to establish i

design basis limits (e.g., analyses of the plant's ability meet its design' bases for natural phenomena and other events such as SBO that the plant -

is required to withstand).

2. Definition of"denarture from a method of evaluation" The phrase " essentially the same," should balance the need to provide licensees some flexibility to refine methods with need to restrict changes to methods of evaluation that move results in the nonconservative direction. To ensure that the phrase " essentially the same" does not become a zero standard for such methodology changes, clear guidance is needed in the Statements of Consideration and NEI 96 07 to provide licensees appropriate flexibility to make minor methodology changes.

We agree with the staff that results that vary due to differences in calculational sensitivities (e.g., rounding errors) between the old and new methods of 4

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r evaluation would be considered " essentially the same." However, we are concerned that additional guidance is needed to distinguish between " essentially the same" and a zero standard for changes that move analydis risults in the nonconservatke direction.

We recommend f hat the Statements of Consideration also reflect that two methods shall be considered " essentially the same" provided that benchmarking demonstrater in it a new or revised method of evaluation produces results that are consistent wi th the old method, and differences between the'old and new results are undel stood by the licensee.

To further clarify the proposed definition of" departure from a method of evaluation," the following additional guidance should also be reflected in the Statements of Consideration:

The following shall not be considered a departure from a method of evaluation described in the FSAR (as updated):

Changes in methods of evaluation that (a) are below the level of detail presented in the UFSAR; (b) are consistent with existing SERs, applicable codes, and industry standards; and (c) do not change the fundamental assumptions upon which the methodology is based.

Use of an updated or new NRC-approved methodology (e.g., computer code) to reduce uncertainty and provide more pfecise results, or other reason, provided such use is (a) based on sound engineering practice, l

(b) appropriate for the intended application, and (c) within the limitations of the applicable SER.

Use of a methodology revision that is documented (benchmarked) as providing results which are consistent with either the previous revision of the same methodology or with another applicable l-

. methodology previously accepted by NRC through issuance of an SER.

To supplement the Statements of Consideration concerning the meaning of

" departure from a method of evaluation," we intend to work with the staff to provide clear guidance in Revision 1 of NEI 96 07 that will assist licensees (and NRC inspectors) in determining, for several common types of analyses, when a

- new method of evaluation is " essentially the same" as the existing method

_ described in the UFSAR.

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3. Methods versus innu_tjt i

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In the public meeting on March 31,'the staff stated that how the# plant and its response are modeled is part of the method (controlled by the proposed criterion (c)(viii)). The characteristics of the plant are input parameters or assumptions, changes to which are controlled by the other seven criteria of 10 CFR 50.59 (and in some cases TS), and which may also be subject to limitations specified in applicable SERs. To make clear this important distinction between changes to methods of evaluation subject to criterion (c)(viii) and changes to input assumptions which are not, the NRC staff proposed definitions to be included in the Statements of Consideration and NEI 96-07. The definitions below are the same as proposed by the NRC except we have added exam iles to the definition j

of methods of evaluation and included input assumptions us the definition of input parameters:

3 Methods ofevaluation means the calculational framework for evaluating behavior or response, as for the reactor or any system, structure or component. This includes the following; Methods of Evaluation Example

)

Data correlations

. DNBR correlations Means of data reduction ASME III and Appendix G methods for evaluating reactor vessel embrittlement specimens Physical constants or coefficients Heat transfer coefficients Mathematical models.

Decay heat models

. Assumptions in the computer No voiding in PWR hot legs for program non-LOCA analyses 4

Specified factors to account for 120% of1971 decay heat model uncertainty in measurements or data Statistical treatment of results Westinghouse Revised Thermal e'

Design Procedure Dose conversion factors ICRP factors Input parameters and assumptions means values assumed for, or derived directly from, the physical characteristics of structures, systems or components, or processes in the plant. These would include such things as: flows, temperatures, pressures, dimensions (volume, weight, size), response times, etc.

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MinimalIncreases in Probability

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We agme with the shift in trerminology to " frequency" of an accident for criterion (c)(2)(i) and " likelihood" of a malfunction for criterion (c)(2)(ii) proposed by the NRC staffin SECY-99-054 far the probability criteria of 10 CFR 50.59.

At a March 2 briefing, the Commission reiterated their intent that the revised rule and guidance provide for licensees to make changes without prior NRC approval that increase frequency of an accident or likelihood of a malfunction by more than a negligible amount. While the proposed rule allowed for " minimal" increases, neither the staff or the industry has provided adequate guidance for making changes that were beyond the negligible threshold.

Restoring the flexibility to make changes that may " negligibly" increase the frequency of an accident or likelihood of a malfunction has been the top priority of licensees in this rulemaking. Nonetheless, the industry supports the Commission's objective to provide the somewhat greater flexibility afforded by the " minimal increase" standard as a means to improve process effectiveness and reduce unnecessary regulatory burden without reducing safety.

Based on discussions in the public meeting with the NRC staff on March 23 and consultations with our industry task force, we have developed proposed criteria and considerations relative to implementing the minimalincrease standard for frequency of an accident or likelihood of a malfunction. These are intended as input to supplement the following Statements of Consideration provided in the proposed rule.

The Commission notes that Sec. 50.59 permits changes that do not otherwise require a,pproval(such as would be the case if the provisions being changed are in TS or heense, quality assurance or emergency plans, or inservice inspection and testing arograms). Because the information being revised is ofless immeiiate importance to public health and safety, and in consideration of the conservatisms m NRC design and analysis requirements, acceptance criteria, and the precision with which safety analyses are performed, " minimal" variations in probability of occurrence or consequences of accidents and malfunctions should not affect the basis for the licensing decision. This conclusion is based upon the qualitative consideration of probability during plant licensing; accident probabilities were assessed in relative frequencies; equ,ipment failures were generally postulated to gauge the robustness of the design, without estimating their likelihood of occurrence. Therefore, mimmal increases in probability could not even have been identifiable, and could not impact the conclusions reached about acceptability of the facility design. Radiological consequences for accidents are calculated and reported at a level of precision such that minimalincreases also would not impact the safety determination. The Commission therefore 7

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.M concludes that the proposed criteria would provide reasonable assurance that those changes that would affect the NRC's basis for licensing would be identified as requiring NRC approval before implementation.

The revised criteria would also provide some degree of flexibility for licensees to make changes with smaller impacts without the need to obtain alicense amendment.

On the other hand, tlie Commission intends to limit the amount of increase in probability or consequences of accidents such that it remains substantially less than a "significant increase" as referred to in Sec. 50.92 (in accordance with Sec. 50.92, a license amendment involving a significant increase in the probability or consequences of an accident previously evaluated involves a "significant hazards considerations;" any hearing for an amendment constituting a i

"significant hazards consideration" must be completed prior to the grant of the amendment.) The standard in the pro aosed rule is qualitative increased). { probability or consequences no more than minimally The intent of this proposed rule is to allow changes that are small enough that they would not affect the facility's licensing basis, or adversely affect safety would allow minimalincreases, performance. While the proposed rule licensee still must meet applicable regulatory limits and other acceptance criteria to which they are committed (such as contained in Regulatory Guides, etc.) Because the "more than minimal" standard allows for there to be a discernible increase, NRC needs to establish a, point beyond which one would 1

conclude that the increase is not mmimal. The following guidance is offered, including values as to when the Commission would conclude that the revised criteria are not met. Quantitative calculations are not required except for those instances in which a licensee offers other than qualitative arguments as part ofits evaluation.

Sunnlemental Inout for the Final Rule Statements of Consideration Criteria are provided below that c6uld be used by licensees as basis for evaluating andimplementing changes to t'he facility or procedures under 10 CFR 50.59 that involve a minimalincrease in the frequency of an accident or likelihood of a snalfunction. The minimalincrease criteria would be applied in a manner such that

. while not all of the criteria will apply to all changes, all that do apply must be true for a change to be considered minimal. For example, the criteria related to new operator actions or increased design stresses will not be relevant to all changes.

Changes that involve a negligible or no increase are not required to be further evaluated against the minimalincrease standard because the NRC has stipulated that negligible increases satisfy the proposed minimum standard. Per the guidance in NEI 96-07, an increase is negligible:

Where a change in probability is so small or the uncertainties in determining whether a change in probability has occurred are such that 8

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L it cannot be reasonably concluded that the probability has actually chan red (i.e. there is no clear trend towards increasing the probability),

the c mange need not be considered an increase in probability.2

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- hm. ' criteria for use w here an increase in orobability is minimal:8

.Anincrease in the frequency ofoccurrence of an accident is minimal if each of the

.followingis true, as applicable:

1 The change would not cause a change in the relevant event frequency clammification.

2. The change would not cause applicable design stresses to exceed their code allowables (e.g., for pipe structural support and internal pressure).

3. The effect of the change on frequency of an accident can be calculated and would not cause more than a 10% increased in the estimated (pre change) accident frequency. As discussed with the staff, it is recognized that the proposed criterion is conceptual / preliminary in nature. In connection with the planned revision to NEI 96-07, a graded approach to this criterion would be developed to allow larger increases for lower frequency events. In addition, other issues would need to be addressed such as use of conservative versus best-estimate analysis and the availability of baseline accident frequencies to facilitate the evaluation.

.An 2ncrease u; se likelikad of occurrence of a malfunction is minimalif each of the followingis tre, as apphcable5:

L The change would not cause applicable Maintenance Rule performance criteria (e.g., for reliability / availability) to be exceeded. It was noted that while MR performance criteria ~can change, such changes must have appropriate basis and be snade under applicable lic.ensee procedures.

'In response to the point made on March 2 by Commission Diaz, the industry believes, based on this guidance, that if the effects of a change are within the margin of error of the original calculation or analysis, the change is negligible. We intend to clarify NEl 96-07 in this regard.

3These proposed criteria differ slightly from those discussed with the NRC staff in the public meeting on Wlarch 23.'

' d The proposed 10% increase criterion is consistent with the NRC report, Options for incorporating Risk Insights into 10 CFR 50.59 Process, December 17,1998, Section 6.4.1.

s Evaluations of a change for(mpact on likelihood of a malfunction would be performed at the level of detail of design description contained in the UFSAR.

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1 %e Annea would not reduce existing design redundancy or diversity provided to meet NRC requirements.

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3. De A=n-a would not cause applicable design stresses to exceed their code aBowables.

4. 'The effect of the change on likelihood of a malfunction can be calculated would

- not cause more than factor of two increase in the estimated (pre-change) s likelihood of a malfunction that is adverse to safety (i.e., component failure to l

other than its safe state).

' 5. The change is intended to conform the plant or proce.dures to changes in the regulations where the licensee ensures that the approach used to comply with y

the regulation does not adversely impact the safety of the plant.

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6. Malfunctions considered as part of the evaluation of the change are estimated to be " green" findings within the significance determination process of the new l-reactor oversight process described in SECY.99-007A.

During the March 23 meeting, the NRC staff put forward the following additional criteria on minimalincrease in the likelihood of malfunction, and we recommend they be incorporated into the Statements of Consideration.

7. The change involves installing additional equipment or devices (e.g., cabling, 2nanual valves, protective features) provided all applicable design, functional and quality requirements (including applicable codes, standards, etc.) continue tobe met. For example, addingprotective devices to breakers or installing an additional drain lin~e (with appropriate isolation capability) would not increase thelikelihood of malfunction.

8. The change involves substitution of one type of component for another of similar function (e.g., substituting an air-operated valve for a motor-operated valve),

provided all applicable design, functional and quality requirements (including applicable codes, standards, etc.) continue to be met.

9. The change involves a new operator action, including manual action that substitutes for automatic action, provided the action (including required completion time) is reflected in plant procedures and operator training programs, and the licensee has demonstrated that the action can be completed in the time required considering the aggregate affects, such as workload or environmental conditions, expected to exist when the action is required.

• The proposed factor of two threshold is consistent with the NRC report, Options for incorporating Risk

}

Insights into 10 CFR 50.59 Process, December 17,1998, Section 6.4.1.

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Other Comments on SECY-99-054?./

4,.

Fm~nna1 Increase in Conseauences In SECY-99-054, the NRC staff accepted, for the most part, the industry proposal for the minimalincrease standard on dose consequences. The industry recommendation was that licensees be allowed to make changes without prior NRC approval that

' increase calculated dose by the lesser of the following:

10% of the margin to 10 CFRlimits, or e

the applicable SRP acceptance guideline (if any)

)

The cae proviso stipulated by the ytaff was that SRP acceptance guidelines for dose consequences would be made to apply to alllicensees regardless of whether they are currentlypart oflicensing basis for the plant.

While this approach provides uniform criteria for all plants, it has impcrtant downsides. First, the staffs approach would effectively establish new regulatory requirements and rigid new restrictions on facility and procedure modifications for licensees that are currently not subject to the SRP acceptance guidelines.

Second, the staff proposalis contrary to the intent to avoid the need for license amendments for changes that increase consequences only minimally. Specifically, forplantslicensed to operate with calculated dose consequences above the SRP acceptance guidelines (but below the regulatory limit established in 10 CFR), the staff approach would require a license amendment for all proposed changes that increase consequences by any amount (a zero increase standard).

To avoid the imposition of rigid new requirements and the burden on both licensees and the NRC associated with unnecessary license amendments, we recommend the NRC adopt an alternative approach that would provide a special, more restrictive, minima 1 increase standard for licensees in the situation desc'ribed above.

Specifically, a licensee that has been approved by the NRC to operate with calenlated dose consequences above the SRP acceptance guidelines could make a change without prior NRC approval provided the change does not increase the calculated dose by more than 1% of the margin to the 10 CFR regulatory limit. The 1% increase limit for such licensees is significantly moro restrictive than that for license.es that are under the SRP acceptance guidelines. But, by providing appropriately limited flexibility to all licensees, this approach will avoid the need forlicense amendments that are clearly unwarranted.

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NRC Anoroach for Exercisine Enforcement Discretion i.

We appreciate the staff's intent stated in SECY-99 054 to refrain fEom enforcement action for non-willful violations of existing $$ 50.59 or 72.48 requirements that would not be violations had the evaluations been performed using the revised rule.

We also understand that the staff does not plan to document such matters in inspection reports.-

However, as part ofits approach to e'xercise enforcement discretion, the NRC staff also stated that"a failure to submit an amendment as required would be considered a Severity Level III violation if either a)a substantial review is needed by the NRC before it could conclude that the licensee's actions were acceptable or b) NRC would not have found the licensee's actions acceptable. [ Emphasis added]

We believe it is unduly subjective to base the decision to issue a Level III violation on whether a " substantial review" was needed to determine that the licensee had performed a proper evaluation. Aside from the " substantial review" c-iterion being inherently subjective, the extent of NRC review needed to verify a licensee's 10 CFR 50.59 evaluation is a function of the complexity of the change and the skill of the NRC reviewer. We strongly recommend that the NRC staff amend its approach for exercising enfoicement discretion by eliminating the " substantial review" criterion discussed in SECY-99 054.

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