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120th Advisory Committee on Nuclear Waste (ACNW) Meeting, July 25, 2000

                       UNITED STATES OF AMERICA
                     NUCLEAR REGULATORY COMMISSION
                                  ***
                  ADVISORY COMMITTEE ON NUCLEAR WASTE
                          120TH ACNW MEETING
                                  ***

                                   Nuclear Regulatory Commission
                                   Room T2B3
                                   Two White Flint North
                                   11545 Rockville Pike
                                   Rockville, Maryland

                                   Tuesday, July 25, 2000

               The Commission met in open session, pursuant to
     notice, at 10:47 a.m., THE HONORABLE DR. B. JOHN GARRICK,
     Chairman of the Committee, presiding.
     MEMBERS PRESENT:
               DR. JOHN B. GARRICK, Chairman
               DR. GEORGE W. HORNBERGER, Vice Chairman
               DR. RAYMOND G. WYMER
               MR. MILTON N. LEVENSON
     .     ALSO PRESENT:

     DR. JOHN T. LARKINS, Executive Director, ACRS/ACNW
     MR. HOWARD J. LARSON, Acting Associate Director, ACRS/ACNW
     MR. RICHARD K. MAJOR, ACNW Staff
     MS. LYNN DEERING, ACNW Staff
     MR. AMARJIT SINGH, ACNW Staff
     DR. ANDREW C. CAMPBELL, ACNW Staff
     MR. N. PRASSAD KADAMBI, Office of Nuclear Regulatory
       Research, NRC
     MR. JACK ROSENTHAL, Office of Nuclear Regulatory
       Research, NRC
     MR. MEDHAT EL-ZEFTAWY, ACRS Staff
     MS. LISA GUE, Public Citizen.                            C O N T E N T S
     ITEM                                                    PAGE
     OPENING STATEMENT                                        4
     ACNW PLANNING & PROCEDURES                               4
     REVISED HIGH-LEVEL GUIDEANCE FOR
      PERFORMANCE-BASED ACTIVITIES                            10 .                         P R O C E E D I N G S
                                                     [10:47 a.m.]
               CHAIRMAN GARRICK:  Good morning, everybody.  Our
     meeting will now come to order.  This is the first day of
     the 120th meeting of the Advisory Committee on Nuclear
     Waste.  My name is John Garrick, Chairman of the ACNW.
     Other members of the committee include George Hornberger,
     Ray Wymer and Milt Levenson.
               During today's meeting the committee will discuss
     committee activities and future agenda items.  We will hear
     remarks concerned the revised high-level guidance for
     performance-based activities, and we will discussed planned
     ACNW reports on a number of topics, including risk-informed
     approaches to nuclear materials, regulatory application,
     comments on the low-level waste NUREG on performance
     assessment, highlights of the visit to the U.K. and France
     and comments on EDO response to ACNW action plan.
               Howard Larson is the designated federal official
     for today's initial session.  The meeting is being conducted
     in accordance with the provisions of the Federal Advisory
     Committee Act.  We have received no written statements from
     members of the public regarding today's session, and should
     anyone wish to address the committee, please make your
     wishes known to one of the committee's staff.
               It is requested that each speaker use one of the
     microphones, identify himself or herself and speak clearly
     and with sufficient volume that he or she can be heard.
               There are some current items of interest I would
     like to mention.  Number one, announcement of a new
     associate director for technical support, Mr. James Edwards
     Lyons of the Office of Nuclear Material -- Nuclear Reactor
     Regulation has been selected as the associate director.  He
     has been a top candidate in the SES candidate program and
     has served in various positions in the Office of Nuclear
     Reactor Regulation.  He has a background in Projects where
     he served as acting project director.
               Over the next few months, Mr. Lyons will have to
     complete some training activities, and we anticipate him
     joining us during the next ACRS and ACNW meetings.  During
     the three months, Howard Larson will be acting as the
     special assistant to the associate director for technical
     support.
               Barbara Jordan of the support staff of the
     ACRS/ACNW support staff has accepted a position as a travel
     voucher examiner and will be departing our staff on August
     4th, 2000, and we want to extend our best wishes and good
     luck to Barbara in her new assignment.
               On Monday, July 10th, the Southeast Compact
     Commission for Low-Level Radioactive Waste Management filed
     a motion and a bill of complaint in the U.S. Supreme Court
     against the state of Carolina.  According to the Compact's
     press release, the action was taken to enforce $90 million
     in sanctions against North Carolina for the state's failure
     to comply with provisions of the Southeast Compact law and
     to fulfill its obligation as a party state to the Compact.
               North Carolina has 60 days from docketing of the
     Compact's filings to file its response.
               On July 12th, Secretary of Energy Richardson
     suspended the release of potentially radioactive
     contaminated scrap metals for recycling from DOE's nuclear
     facilities.  DOE is also undertaking a feasibility study on
     the possibility of recycling steel from decommissioned
     facilities into items such as waste containers.
               An event of some note, a transuranic waste
     shipment left Hanford on July 14th bound for WIPP, 1800
     miles away.  Hanford is the fourth DOE site to ship waste to
     the Department's waste isolation pilot plant near Carlsbad,
     New Mexico, and will send about 2,500 shipments or 80,000
     drums of transuranic waste to WIPP during the next 30 years.
               The seven 55 gallon drums of waste that left
     Hanford are being transported in the NRC approved shipping
     containers.  Another 400 drums of Hanford waste is being
     reevaluated to ensure that the waste meets the State of New
     Mexico's requirements.
               All right.  The subject for the next little while
     is the revised high-level guidance for performance-based
     activities.  As you all know, for the past several years,
     three or four years, the Commission has been moving towards
     more risk-informed and performance-based methods of
     regulation.  There has been considerable progress,
     especially in the area of risk-informed initiatives, perhaps
     with a little less progress of what we mean by
     performance-based regulation.  So, hopefully, we are going
     to get a bit of an update on that.
               The Commission has been very anxious that these
     guidelines are developed with input from stakeholders and
     the program offices.  And I think that as we have reviewed
     this material, it has become sort of obvious that there is a
     number of problem areas.  One of those areas is what
     constitutes reasonable performance measures.  The thought
     here is that we ought to be picking performance measures
     that embrace and encompass a lot of what might be more
     detailed measures of performance and be thinking more in
     terms of the ultimate issues that we are trying to resolve
     here, which is some way to measure safety to workers and to
     the public.  So, performance measures is a key part of this.
               There are some issues that the committee is a
     little bit concerned about in addition to performance
     measures such as the suggestion in the Federal Register that
     this is only going to be implemented on new initiatives.
     What that really means is not completely clear.  The reason
     being given that the NRC has limited resources and may not
     be able to implement it except on new initiatives.
               Given that we have been in the regulatory business
     for several decades, what constitutes new initiatives
     against that large base of experience is something we would
     maybe want to hear more about.
               I think there is no doubt that the idea of
     risk-informed, performance-based regulation is introducing
     some stress into the regulatory process because it is sort a
     departure from a prescriptive approach to regulation, or, as
     some people might refer to it, a speed limit kind of
     approach to regulation whereby, if you meet the prescription
     or the speed limit, you are judged to be okay, but if you
     exceed it, you are judged not to be okay.
               And we know, of course, that radiation safety,
     nuclear safety is not that simple and that we ought to be
     forced in each issue to be looking at the relevance of the
     threat in terms of our safety and risk-informed,
     performance-based strategy, if properly implemented, ought
     to do a better job of that than an attempt to anticipate and
     identify performance measures at a lower level and assign
     values to them, thinking that we really understand the
     safety margins when maybe we do not.
               So, the whole new strategy is one of trying to
     turn up the microscope a little bit on what really is
     important to safety, what we really mean by risk-informed
     and performance-based.  On the surface, it would seem to be
     a very simple concept that we establish ourselves a
     performance requirement such as a radiation dose, and then
     we ask ourselves what is the risk that we may not be able to
     fulfill that requirement.  That perhaps is, in its most
     simple from, what one would expect to see or be and
     constitute risk-informed, performance-based guidance.
               So, we have had quite a number of activities take
     place already.  There was created a performance-based
     regulation working group some several years ago, and I know
     I am stealing a little bit of our colleague's presentation
     here, but I want to set the stage for this.  These
     guidelines were developed in draft form and have been
     published in the Federal Register.  There has been
     workshops, there has been written comments on the
     guidelines.  And the NRC has even responded to the comments
     through the Federal Register published in May.  And then
     there has been an online workshop, and now there are the
     ACRS/ACNW briefings.
               So, there has been a lot of activity here.  There
     is a considerable number of issues involved, the transition
     to a risk-informed, performance-based thought process is a
     major redirection.  I think a lot of the problems come about
     the NRC works very hard to be responsive to everybody, and
     it is a different way of managing safety.  And if we are
     really serious about doing it, obviously, we are going to
     have to do certain things differently, and such concepts as
     defense-in-depth, safety margin, subsystem requirements,
     fitness for duty, all these concepts will have to be
     reexamined in the context of their compatibility with this
     approach, and whether or not force fitting those concepts
     would compromise effective implementation of a
     risk-informed, performance-based process is something I
     think we have to be very alert to.
               So, we are going to hear from Mr. Kadambi, Prassad
     Kadambi from Research, and I hope he has some updates on
     some of these questions.
               You have the floor.
               MR. KADAMBI:  Thank you, Mr. Chairman.
               I would like to ask if my boss, Jack Rosenthal,
     has anything to say on behalf of our branch?
               MR. ROSENTHAL:  Thank you.  Jack Rosenthal,
     Regulatory Effectiveness Assessment and Human Factor Branch
     in RES.  It took me a week to get the full title.
               I just want to just put this in a little timing
     context, and that is that we have been working on this for a
     year or so.  As Dr. Garrick said, we have had a number of
     public meetings.  We owe the Commission a SECY paper in
     mid-August.  We have met with the ACRS, we are now meeting
     with you.  The paper which will ultimately be prepared
     describes the effort, presents the guidelines, speaks at
     length to greater -- to public comment.  And when we
     published the Federal Register Notices, we didn't have the
     luxury of writing at length on public comment, but to be
     responsive to the public, I am sure that we will achieve
     that goal here, that we have the space, and we will present
     some examples of a trial, a proof of principle application
     of the guidelines.  So that is where it fits into the
     broader context.
               And with that, why don't we let Prassad get
     started.
               MR. KADAMBI:  Thank you, Jack.
               Good morning, I appreciate the opportunity to
     address the Advisory Committee on Nuclear Waste.  I believe
     this is the first time -- well, for me it is the first time
     coming to this committee, and I believe it is the first time
     you are hearing about the staff's performance-based
     regulation effort.  I could be wrong in that.
               We did make a presentation to the ACRS on June
     8th.  We have spoken with the ACRS before on this matter.
     This briefing is primarily for information.  We are not
     expecting a letter but we would very much like feedback from
     the committee, and, of course, if you would like to write a
     letter, you know, that is certainly your prerogative.
               The title is "High-Level Guidelines for
     Performance-Based Activities."  Based on my experience with
     the ACRS on this, I would like to just get a couple of
     things out of the way right upfront.  First is when I speak
     of high-level, one of the things that has happened when I
     have tried to describe this work for people from the
     materials area is their mind immediately goes to high-level
     waste.  That is not the connotation at all.  Here what we
     are talking about is the level of conceptualization and
     generalization, the generality of the guidelines.  Because
     they are high-level, we believe that they can be applied to
     reactors, materials and waste arenas.
               The second term is with performance-based
     activities.  There was some confusion as to what activities
     meant.  At this point what we mean is primarily NRC
     activities, and it is associated, basically, with developing
     or modifying regulatory requirements to see if we can make
     them meet the Commission's guidance, the directives that the
     Commission has given on what constitutes a performance-based
     approach.
               This is an outline of my presentation this
     morning.  I would like to present some historical background
     which maybe the Chairman has covered a little bit of that.
     I would like to get into a little more detail on what the
     Commission has asked the Staff to do.
               We have had, as the Chairman mentioned,
     interaction with stakeholders and I certainly am gratified
     by the attention that some of our stakeholders have given
     this topic and I think it is very useful to engage in a
     discussion with all concerned.
               We will get into the risk information and how it
     is tied into performance-based initiatives and we can
     discuss the guidelines themselves and I would like to
     provide the committee with the latest thinking on what the
     Staff expects to do from here on out.
               If we do talk about the guidelines themselves, I
     have copies of the guidelines in detail, which we can pass
     around.  I would rather use those than the sort of cryptic
     bullets that I have.
               As the Chairman mentioned, we are not as far ahead
     in the area of performance based regulation as in some other
     initiatives that the Staff has undertaken, primarily the
     risk inform regulation initiatives, but we are fulfilling
     the Commission's directives in this subject area.  We are
     making steady progress while we do this.
               The development of the high level guidelines and
     their limited testing represents a significant milestone.
     The degree of progress that we have made is I think
     commensurate with the resources that we have allocated.  It
     is a relatively low level effort and we have made
     incremental progress towards achieving the goals of
     performance based regulation.
               By that, one thing that should be made clear is
     that it does not mean either less regulation or more
     regulation.  It is merely what I would suggest is "smart"
     regulation and it is an effort that complements the
     risk-informed regulatory approaches.
               The guidelines have been tested in a limited
     manner.  I think they need to be tested over a wider range
     of issues and to identify some challenges which may limit
     their application.  Eventually I see that this effort will
     be integrated with the mainstream efforts ongoing in other
     areas and right now primarily those are the risk-informed
     efforts.
               Now the Commission has been quite really emphatic
     in its commitment to risk-inform performance based
     approaches to regulation.  They started essentially talking
     to us through the direction-setting issue papers that
     started in 1996 and they continued to this day with various
     issuances and right now they are really an important part of
     the Strategic Plan in which performance based approaches are
     mentioned in each of the strategic arenas.
               The first SRM in this was issued in January, 1997
     and as I mentioned we have made steady progress in it, but
     when it started it was really focused on -- this is
     terminology I am using that was part of an early SRM --
     issues not amenable to PRA, and you know, that is what we
     tried to focus on early-on but I think we have gone past
     that into what I will be talking about as how
     risk-information is used in order to help pursue some of
     these initiatives.
               The most recent paper that the Staff issued was
     99-176, and to put it rather bluntly, it was not received
     favorably by the Commission and the way I saw it was that
     the Commission wanted the Staff to make much more aggressive
     progress in this and the plans that we offered did not meet
     the Commission's expectations because it lacked specificity
     and what we were trying to do was to gather the lessons from
     many ongoing efforts within the Staff which are labelled as
     performance based efforts and we wanted to learn what that
     teaches us before we got very specific about it.
               We did make a presentation to ACRS in June of 1999
     and the ACRS wrote a letter which was included in the
     Commission paper itself and basically the ACRS included this
     topic along with some other risk-based performance
     indicators efforts.
               The SRM really is -- for SECY 99-176 -- the SRM is
     quite clear in what the Commission expects of the Staff and
     we have tried to fulfill those expectations, as I hope will
     come through the presentation today.
               The basic direction of the Commission in this SRM
     was that we should develop high level guidelines to identify
     and assess the viability of candidate performance based
     activities.  Again this was something that we had
     anticipated in the last Commission paper, in SECY 99-176.
     We had expected that this would be a downstream activity
     which after we had learned the lessons from several ongoing
     performance based activities we would be able to then
     develop some guidelines, but the Commission essentially
     advanced the schedule and said, you know, I think we know
     enough to develop guidelines and please go at it.
               But the SRM also contains some other elements.
     The guidelines should be developed with input from
     stakeholders and the program offices.  The guidelines should
     include a discussion of how risk information might assist in
     the development of performance based initiatives.  They
     should be provided to the Commission for information.  In
     fact, we have already provided a copy of the first draft of
     the guidelines to the Commission -- that was in January of
     this year.  I take some comfort that we did not hear
     anything about it.  I assume that if there were any
     objections to it we would have heard.
               Then the Commission also wants the Staff to
     provide its plans and the progress in developing the
     performance based initiatives.
               We believe that the guidelines that we have
     developed will provide the framework for the kind of focused
     and integrated activity that the ACRS had suggested we
     should do, consistent with the ACRS advice.
               As part of working with the program offices, one
     of the first things we did was create a working group, the
     Performance Based Regulation Working Group.  It includes
     representatives from NRR, NMSS, the Office of Research and
     more recently a regional representative.  We have met
     essentially as needed in order to share our views and try to
     expedite reaching a Staff consensus on the issues at hand.
               We have published, as the Chairman mentioned,
     several Federal Register notices.  The earliest ones, on
     January 24th and February 17th, were directed to a workshop
     and the workshop was held on March 1st.  This was a
     facilitated workshop with people representing various
     stakeholder interests, a roundtable and free-wheeling
     discussion that occurred essentially throughout the whole
     day.
               We had people from UCS, Public Citizen -- in fact,
     the two different groups within Public Citizen, those who
     follow the reactor effort and the waste effort -- we had
     utilities, we had representatives from radiopharmaceutical
     companies, we had NEI and some others also over there, and
     it was an interesting discussion.
               We had written comments also from a wide range of
     external and internal stakeholders.
               We published another Federal Register on May 9th.
     We responded, provided an initial response to the comments,
     and we held an online workshop on June 8th, last month, and
     that really elicited a very limited response.
               One thing that I want to say about the stakeholder
     comments so far is we have noted that at least one
     significant stakeholder has expressed a feeling that their
     concerns have not been taken seriously.  I regret if we
     omitted something in the way we responded that would convey
     this impression, but we certainly don't want to give the
     impression that the views of stakeholders are not
     considered.
               Perhaps the approach we took was a little cryptic
     in that sometimes we take the easy way of telling people
     what we do and why we do it by saying that, well, the
     Commission asked us to do it and therefore we did it, but we
     do hope to offer a better explanation for what we did and
     why we did it.
               In general though, I would characterize the
     stakeholder input as not being necessarily unfavorable to a
     performance based approach, although the guidelines
     themselves I should say -- you know, they were not
     unfavorable to the guidelines themselves but one notes that
     those who are favorable to a performance based approach were
     more in favor of the guidelines, and those who were opposed
     to the performance based approach had various concerns about
     the guidelines, and this is my own characterization -- that
     they fell into concerns expressed on implementation and
     trust issues.
               Implementation, what I mean is that there is a
     concern that the Staff may not implement the guidelines
     objectively.  Because they are high level guidelines and the
     express concepts, it does require more specificity before
     you start applying it in particular issues.
               The sort of concern that we heard was that if you
     went to a performance based approach you would be waiting to
     see broken waste containers, high level casks on the side of
     the road before the NRC did anything about an issue.  That
     is certainly not where a performance based approach would
     take us, I believe.
               The other, the trust issues, what we heard was a
     concern whether the Staff would apply these guidelines in an
     even-handed way to increase regulatory requirements if that
     is the appropriate thing to do, just as we might decrease
     regulatory requirements to reduce unnecessary regulatory
     burden.
               These are the kinds of things that we would want
     to demonstrate, that we will use the guidelines
     appropriately, responsibly and equitably.
               One of the things in the SRM that the Commission
     wanted the staff to address was the use of risk information
     relative to performance-based initiatives.  Basically, we
     have characterized the use of risk information in three
     categories.
               The first is that risk information can provide a
     basis for a level of performance that we would demand of
     equipment systems, components, structures level.  And this
     would arise from answering the question, what is important
     to safety?
               And when we know what is important to safety from
     a risk assessment, then we would try to answer the question,
     what is the required level of performance to provide the
     kind of risk amelioration that you make seek, that you learn
     through the risk analysis.
               The third then, depending on how you aggregate the
     performance aspects, would be, what are the appropriate
     performance parameters and the associated performance
     criteria?
               Now, when we talk of performance in this manner, I
     believe what we are talking about is operational performance
     as well as performance under accident conditions.  So, we
     would be talking about operational risk, as well as accident
     risk, as is appropriate.  We can also take into account
     things like normally operating systems versus standby
     systems, versus passive features of the regulated
     environment.
               The appropriate performance parameters, and I
     think this is something the Chairman recognized, is really a
     challenge and these are the sorts of things that we want to
     work through on specific cases.
               The second category is where risk information can
     be used for metrics, thresholds and/or regulatory response.
     The sort of example that I would offer for this is the
     reactor oversight program as it currently works.  And if you
     look at the metrics and thresholds, essentially, as we go
     into the guidelines, you will see that these are reflective
     of the aspects of the viability guidelines in a
     performance-based approach.
               Then there is the category of initiatives
     classified as not amenable to PRA.  Again, this is
     terminology that, just for consistency, I am carrying
     forward from an early SRM.  But this includes things like
     quality assurance or training which are not directly modeled
     quite often in PRAs.  So, these --
               CHAIRMAN GARRICK:  But, of course, that is
     different than making the observation that it is not
     amenable to PRA.  I mean there is a big difference between
     saying that it is not modeled and it is not amenable,
     because I fail to see how any of this stuff is not amenable
     to PRA, it is just a matter of scoping.
               MR. KADAMBI:  I agree, and that is the reason why
     I am careful to put that in quotes.
               CHAIRMAN GARRICK:  Yes.
               MR. KADAMBI:  I guess what I am trying to say is
     that when you are talking about risk information and using
     it for performance-based initiatives right now, it is -- in
     a sense this category is characterized by a lack of risk of
     risk-specific information.  So that is -- it is just the
     categorization that we are proposing right now in response
     to the Commission's question.
               Okay.  We get into the guidelines themselves.  If
     there is any discussion on the guidelines themselves, I
     would like to use the specific language that we have
     developed through the working group efforts because these
     are very cryptic headline forms and sometimes may not convey
     what we intend.  But let me just quickly go through at least
     the structure of these guidelines.
               The first point I want to make is that these high
     level guidelines are not meant to be used as a cookbook of
     some sort where you can run through a formulaic process and
     come up with any conclusions.
               The second point is that there is a high degree of
     context specificity that should be expected as you go
     through these guidelines.
               The first set of guidelines are called viability
     guidelines and these are -- they are four in number, and
     they are essentially exactly the same was what the
     Commission provided in a white paper on risk-informed,
     performance-based regulation.  The white paper was part of
     an SRM to Commission paper 98-144, so that is the way I
     referred to the white paper, as the SRM to SECY-98-144.
               And under performance-based approach, the
     Commission suggested that there be four attributes.  One is
     that measurable or calculable parameters should be available
     or can be developed.
               The second is that one can have objective criteria
     associated with the parameters.
               The third is that once you have set the
     performance parameters and the criteria, the licensee should
     have the flexibility to design the programs and processes to
     meet the criteria.  That there should be some provision to
     encourage improved outcomes as part of providing this
     flexibility.
               And the fourth attribute is that even if the
     criterion is not met, that there be no immediate safety
     concern.  And by talking about an immediate safety concern,
     the way we are applying it is to say that there is a
     sufficient safety margin to alert the licensee and the
     staff, if necessary, that a criterion has been exceeded or
     missed, that there is time for corrective action to be
     taken, and that the licensee is capable to detect and
     correct the performance degradation that would be implied by
     the criterion not being met.
               So, these are what we call the viability criteria,
     and I believe that, you know, when these are applied in a
     structured and a disciplined way, you know, some of the
     concerns that have been expressed about, you know, a
     performance-based approach just waiting for things to go
     wrong would be alleviated, these concerns, because
     especially the fourth attribute really forces the analyst to
     look very specifically at the margin of safety in a rather
     focused way, depending on what the safety issue is that is
     being worked on.
               Now, one of the questions that was asked by,
     actually, ACRS was, you know, are these all that the staff
     came up with?  I mean if the Commission offered these four
     attributes and we thought that they were not sufficient, I
     think we would have proposed, we could have proposed others.
     But I feel, especially having worked through a couple of
     simple exercises, that these really provide the kind of
     leeway for applying high-level guidelines, you know, because
     the selection of parameters is, you know, it can be
     measurable or it can be calculated, which means that you can
     use analyses.  The objective criteria can be based on
     performance history if one has enough performance data to
     fall back on, you know, that would be certainly a basis.
     And depending on things like uncertainty, you could use
     deterministic analyses or risk insights.
               So, anyway, in a nutshell, at least based on the
     work done so far, we feel that these viability guidelines
     are sufficient to let us know whether a candidate activity
     is a viable candidate to make performance-based.
               So, the first set of guidelines represented really
     answering the question, can it be done?  And the second set
     of guidelines, the way we see it, is addressing the
     question, is it worth doing?
               And to begin to answer this question, you know,
     what we -- the approach we used was to begin with what the
     Commission's performance goals are.
               The Commission has indicated that, you know, we
     should strive for four performance goals:  One is to
     maintain safety; two is to increase public confidence; three
     is to increase effectiveness, efficiency, and realism; and
     the fourth is to reduce unnecessary burden.
               So, these four performance goals, we believe can
     be addressed in an integrated manner to try to see whether a
     given performance-based initiative would be worth pursuing.
               And, of course, if the answer is no, then it would
     be discarded, and whatever conventional approaches that we
     use now would probably be applied.
               The next guideline really has to do with, again, a
     rather common-sensical question as to what is the net
     benefit from doing this?  This is, in a sense, a
     cost/benefit analysis, but rather than get trapped into to
     trying to define costs and detailed aspects of how the costs
     are calculated, what we have tried to do is have the
     guideline as something of a qualitative assessment on the
     merits of pursuing a change, and to examine the benefits
     that would accrue to NRC or the licensees, and a simplified
     assessment, you know, something like --
               As an example, I would say, you know, is there a
     lower work exposure to radiation that one can see, you know,
     which would provide a net benefit, you know, without getting
     into a lot of costs?
               Something that simple may be enough to say that
     it's worth pursuing.
               [Pause.]
               Then continuing on the second set of guidelines,
     there is a guideline on the regulatory framework.  And what
     we mean by the regulatory framework is the combination of
     the regulatory features that address a given issue, a safety
     issue, and that includes the regulation that is the Code of
     Federal Regulation, the rule, any regulatory guidance that
     we may have developed to provide one way for the rule to be
     complied with.
               There are occasions when we develop NUREG
     documents to provide details on, you know, things that are
     in the Regulatory Guide or in the rule itself.  There are
     times when we develop Standard Review Plans in order to help
     the Staff conduct its review against a rule.
               There are technical specifications which at the
     operational level provide the requirements that licensees
     have to meet.
               And there is inspection guidance.  This is what
     inspectors look for and really constitute part of the
     regulatory framework.
               So what this is saying is that when we apply this
     guideline, we would be looking at the framework as a whole,
     and not individual components in isolation, and that either
     one or more of the components can be made more
     performance-based.  That would be the question to ask.
               And, in fact, you know, it may be that one has to
     focus attention on some particular level in this hierarchy
     within the regulatory framework in order to gain the
     benefits of a performance-based approach.  We have found
     that to be the case in a couple of exercises that we have
     gone through.
               The next couple of guidelines are based basically
     on the public comments we received, that really should be
     the responsibility of whoever proposes the changes.  In some
     cases it may be the NRC; in some cases it may be an industry
     group or somebody else.
               The last of these guidelines is that, you know,
     inspection and enforcement considerations should be
     addressed early in the process, rather than as has happened
     in the past, often it's an afterthought that comes much
     later in the process.
               The last of the guidelines under Section 2 is that
     new technology should be accommodated in a performance-based
     approach.  This is if one has a set of parameters
     sufficiently well defined, and you have acceptance criteria
     for them, then it should really be amenable to applying the
     latest changes in technology in such a way that, you know,
     the safety issues are properly addressed.
               The last set of guidelines have to do with the
     consistency with regulatory principles.  This is just sort
     of a catch-all to make sure that we have not gone off track
     in some significant way while we go through this process.
               And it includes things like the principles of good
     regulation, the PRA policy statement, Reg Guide 1.174, which
     has to do with licensing basis requirements in reactors,
     primarily.  But the principles are applicable much more
     widely.
               And the strategic plan, of course, philosophical
     issues like defense-in-depth and treatment of uncertainties
     would also be definitely part of it.
               [Pause.]
               Now, what do we plan to do from here on out?  Just
     briefly, I'd like to say that we plan to build on the
     progress we have made.  The progress includes a couple of
     simplified exercises where we have looked at initiatives
     that, one of which is underway as part of the risk-informed
     initiative.  Option 3, it's called in our jargon.
               It's a regulation having to do with combustible
     gas control that's being considered for change.  We selected
     one part of it, and just went through an exercise of
     applying the viability guidelines.
               And although we are trying to prepare the
     documentation on it to support a Commission paper which is
     due very soon -- it's due to the EDO on the 15th of August
     and we intend to meet that date -- we are trying to put this
     altogether.
               But basically the point I'm making is that it
     looks like the guidelines work in terms of taking you
     through a thought process that leads to the right kind of
     questions to ask, to modify the regulatory framework where
     it makes the most sense.
               So, there's another exercise which we are planning
     to conduct very soon, in a matter of days, and this has to
     do with Subpart H to 10 CFR Part 20, Respiratory Protection.
               This rule was changed just last year, in October
     of last year, and basically the change was made to remove
     some of the very prescriptive aspects of the earlier rule,
     and to provide flexibility and some reduced regulatory
     burden, while making sure that there was no decrease in
     worker protection.
               So, these were the sorts of things that, you know,
     a performance-based approach would aspire to, so we are
     trying to see how the guidelines might be useful in
     assessing the kind of improvement that was instituted there.
               But as we try to apply these guidelines and make
     more progress in it, we hope that we can institutionalize
     the use of the guidelines, and have it become part of the
     planning, budgeting, and performance measurement process,
     and eventually it would become part of what the Staff does
     during the normal course of operating plans and budget
     resources, et cetera.
               Right now, we are suggesting a one-year trial
     period in our Commission paper, and we would apply it to
     suitable rulemaking and regulatory changes.  Eventually we
     would have to have procedures for the Staff to use it within
     each of the Offices, and in a way that would be helpful for
     the particular issues that each Office deals with, or even
     portions of the Office that they address.
               And going further out, I would think that if the
     guidelines are found to be useful, they could be, you know,
     made available to Agreement States and to industry
     organizations, including standards committees, because there
     are a lot of people who would like the standards-developing
     process, the standards-developing organizations, to become
     more of what they call performance-based.  So it would be
     good to have a consistent set of guidelines to inform that
     effort.
               And we would report to the Commission on the
     results of this trial period about a year from this paper.
               In conclusion, I believe that the Staff has
     responded to the elements of the SRM, as directed by the
     Commission.  We will reflect whatever Advisory Committee
     inputs we receive in the paper that we will send up to the
     Commission by August 21st.
               By the way, copies of the basic information that
     was provided to you was also provided to ACMUI, the Medical
     Advisory Committee.
               Generally, I believe the guidelines themselves
     were favorably received.  Maybe I don't characterize all of
     the views, but, generally, I think, you know, people didn't
     point to any major problems with specific guidelines.
               And the Advisory Committees will be kept informed.
     We will provide whatever we come up to all the Committees.
     That concludes my presentation.  Thank you, Mr. Chairman.
               CHAIRMAN GARRICK:  Thank you.  I suspect that the
     members have a few questions.  Milt, we'll start with you.
     Do you have any questions?  You better pull your microphone
     down.
               MR. LEVENSON:  Well, I have a question which
     borders a little on the philosophic, but in most fields of
     engineering, we do our best effort to calculate something,
     and then premeditatedly add a safety margin, whether it's a
     factor of two, a factor of five, or a factor of ten.
               When you use deterministic things, as we've been
     doing in regulation, you really have no idea what the safety
     margin is.  We have the potential in performance-based
     activities to, in fact, separate safety margin and apply
     specific safety margins.
               Has any thought been given to what is required in
     order to do that, in a way?  Is it the guidelines for doing
     the performance assessment that have to be consistent and
     uniform?  You can't arbitrarily assign bounding calculations
     one place ten times what's normal and in other place, 20
     times what's normal?
               That there is something inherent in
     performance-based is really to do the best analysis you know
     how, and then get concurrence on how big a safety margin you
     add.  Has this potential aspect of performance-based been
     considered at all in what you're doing?
               MR. KADAMBI:  I believe the answer to your
     question is yes, because it's really embedded in the
     guidelines themselves.  I think it occurs in a couple of
     different places.
               It occurs within the viability guidelines
     themselves, and also it is part of the guidelines that deal
     with effectiveness and deficiency, where, you know, you have
     to make sure that there is a sufficient safety margin, but
     if it is a safety margin that is, you know, not based on
     robust information, if it uses deterministic analysis, you
     know, which may not reflect the actual circumstances that
     the performance demands, then I think the guidelines force
     you to make those kinds of inquiries.  That's my own view.
               MR. LEVENSON:  Well, from what little we've seen
     or heard here, it isn't obvious to me, where they are.  I
     would expect there to be a separate guideline as to how one
     determines what is an appropriate safety margin to use in
     any case.
               The size of the safety margin should be a function
     of how bad are the consequences.  And if it's embedded,
     generically, I don't know how you do a good job of
     identifying that.
               MR. KADAMBI:  Well, I guess I'm not sure that I
     can give you an answer that would fit all cases, because I
     think the guidelines are meant to be sort of things that you
     apply in specific areas.
               I mean, for example, if you're dealing with
     transportation, it would be one set of approaches in terms
     of what kind of safety margins you deal with, as opposed to,
     you know, waste disposal facility or even in reactors,
     whether you're talking about the reactor coolant system or
     the containment system.
               So, I mean, I'm reluctant to offer much by way of
     a definitive answer, but I believe the language of the
     guidelines is that a sufficient safety margin exists.
     That's what it says in the Attribute D of the Viability
     Guidelines.
               And I think what we mean by that is that it should
     be definitely enough to make sure that even if the
     performance parameter is exceeded or is not -- the criterion
     is not met, that you don't face an immediate safety concern.
               MR. LEVENSON:  Yes, but that's a different issue.
     In fact, you're not setting specific safety margins as you
     normally do in engineering.  I don't expect an answer.  This
     is a work-in-progress, and you were asking for feedback.
               MR. KADAMBI:  Yes.
               MR. LEVENSON:  And I'm just saying that from my
     personal standpoint, one of the potential advantages of
     going this way is that you can separate out and say we've
     done the best analysis with the best data we have, and now
     we're going to add another safety factor of ten or two or
     five, depending on consequences.
               And that doesn't seem to me to be inherent in the
     guidance you have so far.  And maybe it is; maybe it isn't.
     That's just personal feedback.
               MR. KADAMBI:  Okay, well, thank you for the
     feedback.
               CHAIRMAN GARRICK:  Ray?
               DR. WYMER:  I don't have a question.  I have a
     comment.  Like so often when I hear these general high level
     type criteria, goals, things that are not specific, I have a
     hard time understanding them.  I have a hard time wrapping
     my mind around that.  At best, I really only understand them
     when I see them applied to specific fairly large, complex
     cases, because then I have a lot better grasp of what they
     really mean and what they are trying to do.
               That's sort of what Milt was getting at a little
     bit, I think, too, and so I guess what I would say is I look
     forward to and would expect to, sometime in the not terribly
     distant future, to hear a discussion of the application of
     these things to a real live, large, and fairly complex
     situation so that all the facets of these guidelines are
     brought out, so that at least I can understand them.
               That is all I have to say.
               MR. KADAMBI:  We will try to do that.
               CHAIRMAN GARRICK:  George?
               DR. HORNBERGER:  I basically had a similar
     reaction to Ray's.  I was going to make essentially the same
     point.
               I am curious along those lines.  To a certain
     extent your high level guidelines obviously make sense.  You
     know, you find a parameter directly related to safety that
     you can measure easily and monitor in real time and et
     cetera, et cetera.
               My question is you must have given some thought as
     to how they might apply to a somewhat more complex case.
     You mentioned you were doing a simple case, or a relatively
     simple case with combustible gases, and I don't know much
     about this, and I am not looking for a tutorial on
     combustible gases, but I could at least postulate a
     situation where you might be looking at a gaseous emissions
     parameter and basically say fine, you want the activity
     level to be less than "x" and you are going to regulate that
     way, and then you let it up to the licensee to determine
     whether it is satisfied by precipitation or filters or
     whatever.  That sort of makes sense in the performance based
     language.
               On the other hand, then I think about it a little
     more deeply.  That radioactivity doesn't just go away.  It
     goes perhaps into the fly ash, and then the question comes
     in an overall systems framework have you improved things by
     having rewarding the licensee for putting the radioactivity
     into the fly ash, which then has to be disposed, and is
     there some other performance measure that should somehow get
     weighed in there.
               It is a hypothetical, but have you gone through
     the thinking as to how you would deal with fairly
     complicated situations?
               MR. KADAMBI:  I have done some thinking on my own
     on this.  It is not -- at this stage of development, you
     know, in the Staff's work we are not really at a stage where
     we can try to answer some of these questions, but I think
     there is no doubt that there are different levels of
     aggregation within a hierarchy that you can put these things
     together.
               You can bring systems together into providing a
     functionality and then you can start putting things together
     in different ways, sort of, you know, the opposite of the
     reductionist approach, and you can apply the same principles
     though at whatever level one chooses to apply it, as long as
     you define the boundary conditions and say that whatever
     conclusions are drawn apply within those boundary
     conditions, so I believe that the benefit of the guidelines
     is that it sort of forces you into answering some of these
     questions as to draw the boundary lines around the issue and
     also points to the limits of whatever conclusions that you
     can draw from it.
               CHAIRMAN GARRICK:  I just want to leave a couple
     of comments with you.
               One is on this issue of performance measures.
     When I hear people talk about components and safety trains
     and systems and release and what have you as candidates for
     performance measures, I get a little nervous.  If we are
     really genuine about risk informed performance based
     regulation, and if we are really genuine about relieving
     licensee and licensing burden, I think in the guidance we
     want to be very careful to be offering guidance on measures
     that integrate the effect of what all of these measurements
     of all of these subunits might constitute, and this is why
     the NRC is in a bit of a dilemma in their reactor side right
     now is because the principal measure is core damage
     frequency and in a sense you can argue that that is not
     really a major risk in the spirit of the Atomic Energy Act,
     which is to protect the health and safety of the public.
               Now to be sure, it is a precursor and a pretty
     darned important one, but the point is if you are really
     genuine about performance based issues the performance of
     core damage in one plant has a different impact on safety
     risk than that same core damage frequency in another plant,
     so I think that one of the things you would be very
     well-advised to do is to be thinking in terms of performance
     measures that carry out as much of the integration, of the
     impact of other measures as possible.
               The ultimate integrator, of course, is health and
     safety to workers and the public.
               The other thing I want to mention is that in your
     guidance I think you also need to be very careful about
     putting constraints on what is meant by risk assessment
     itself.  To do a risk assessment and not be sensitive to
     crew performance for example, or operator performance for
     example, or fitness for duty for example, is not doing a
     risk assessment, and yet there is the indication in the
     guidance that these are outside or the implication that this
     is outside the scope of PRA.
               As I said earlier, it may be outside the scope of
     a specific PRA because the analyst chose to do it that way,
     but the thought process is not constrained in any way, and
     we all know that the evolution of risk assessments of
     nuclear power plants has been extensive with respect to
     increasing the amount of time we spend in addressing
     operator performance, for example, which with that kind of
     thinking one might say is outside of a PRA.
               So we should not confuse what has been done or
     maybe what the practice is as to what could be done, and we
     all know that there is some very interesting work going on
     in the human factors arena, human factors research, in
     organizational performance research in terms of being able
     to embrace those kinds of impacts into our models, so that
     is just a couple thoughts that I would like to leave you
     with.
               Okay.  Are there any questions or comments from
     the Staff?
               DR. HORNBERGER:  Could I ask you a question?
               CHAIRMAN GARRICK:  Yes.
               DR. HORNBERGER:  I don't think that I quite
     understand your statement that one could go directly to
     something like human health as a performance measure.
               It seems to me that that really would go to the
     problem that some people have pointed out, that if you ever
     measured human health effect you would say it is too late
     and it would violate I forget which of the -- IV in the
     guidelines.
               It seems to me that you have to have some
     surrogate performance measure well before human health.
               Did I miss something?
               CHAIRMAN GARRICK:  Well, partly and partly you
     didn't.  My philosophy on this is that clearly you do
     calculate what these precursor events are in terms of their
     likelihood of occurrence.
               As a matter of fact, if you do the right kind of
     job of calculating something like a health effect you should
     have embodied in that analysis a very transparent indication
     of what these precursor contributors are to that health
     effect risk, but what I am saying is that I can envision
     scenarios that would improve the performance of a nuclear
     power plant, for example, in terms of core damage frequency
     that would actually increase the risk to the health and
     safety to the public.
               That is the thing that we have got to be very much
     on the alert for is that ultimately we are committed here to
     protect the people and the environment, and it just seems
     that if we are talking about high level guidance and we are
     not starting with the people and the environment, and we are
     worrying about components and trips and what have you, we
     are on the wrong track because that is plant-specific, it is
     facility-specific, and general guidance on that in most
     cases won't have much meaning in a specific application.
               So, no, I don't think that you get into a
     situation where you don't understand very clearly what the
     role is of a subsystem or what have you with respect to an
     overall and overarching performance measure, but I am
     suggesting that we ought to be addressing measures that
     really address explicitly what it is we are concerned about
     and what it is we are concerned about and obligated to is
     protect the health and safety of the public, and if we don't
     focus on that then we are missing the boat.
               I think that we have got quite a bit of work to do
     in some of these areas in that arena.
               Okay, yes, Milt?
               MR. LEVENSON:  I have a question.  I am a little
     confused.  I made the mistake of going back and reading your
     viewgraphs, and one of them says that the Commission
     directed Staff to develop high level guidelines to identify
     and assess the viability of candidate performance based
     activities.  I guess it isn't very clear to me how the
     guidelines that you have discussed could be used to identify
     and assess viability of performance based activities.  I am
     not sure what those words mean.
               MR. KADAMBI:  Well, the way I have interpreted the
     words is to say that the guidelines become attributes which
     would characterize a performance based activity.  In other
     words, if there is a candidate activity and you want to
     determine is it performance based right now, you would use
     the guidelines as attributes to compare its existing
     attributes with what are the attributes of a performance
     based activity.
               If there is a difference between the two, you
     would say, well, it may be worthwhile making this activity
     performance based by changing the attributes in some defined
     way.
               MR. LEVENSON:  Okay.  John, just as a follow-up to
     your comment about core damage, you know we need to remember
     there have been 12 reactors that have had core meltdowns and
     Chernobyl is the only one with any significant health safety
     impact, so core damage per se doesn't automatically mean
     that.
               CHAIRMAN GARRICK:  That is part of the point.
               Okay.  We have a request for somebody to make a
     comment from the Public Citizen group.  I think we ought to
     accommodate that right now, and would you announce your name
     and affiliation, et cetera?
               MS. GUE:  Yes, thank you.  My name is Lisa Gue.  I
     am a Policy Analyst with Public Citizen's Critical Mass
     Energy & Environment Program.
               Public Citizen has previously given comment on
     this issue both through the workshop process and also in a
     statement to ACRS committee as well, but I do appreciate the
     opportunity to briefly just outline our main concerns with
     this process to your committee as well.
               I think Mr. Kadambi has accurately categorized our
     concerns into those relating both to confidence and then
     also implementation, and in terms of confidence I guess
     fundamentally we are concerned with a process that orients
     itself with the objective to reduce regulatory burden to
     licensees.
               The regulatory structure should emphasize safety
     at its core, as you mentioned, Mr. Chairman, and if this is
     too much of a burden on industry, then the industry itself
     is not viable.
               Secondly, relating to our confidence concerns, I
     guess, is that we are skeptical of the benefits of the
     flexibility, of providing flexibility to licensees in terms
     of how they meet these performance objectives.
               We find it hard to believe that this is actually
     going to result in industry clamoring to be more creative,
     to be more stringent in how they protect public safety.
     Certainly from a public interest perspective, historically
     we don't really have any reason to be confident that this
     would be the result and certainly from an economics
     perspective it would seem that the more likely scenario
     would be for a race to spend as little money as possible,
     resulting in cost-cutting to meet the lowest possible
     standards.
               Relating more to the implementation concerns,
     clearly the risk information to determine, using risk
     information to determine performance indicators would be key
     to the process, as the presentation indicated, and yet
     thinking of the Yucca Mountain proposal right now for a
     repository and also an unprecedented transportation program
     of high level waste and spent fuel, I guess our concern
     would be that our ability to accurately assess the risk is
     really limited by a relatively short history of experience
     in this area, and I mean that relative both to the scale of
     the transportation program, of the specific transportation
     program that is being considered for the Yucca Mountain
     repository and also in terms of the license period for that
     repository.
               Secondly, that same ability to accurately assess
     the risk is limited by simply the limits of our own human
     imagination to conceive of the possible risks, given the
     shortcomings of experience in that regard.
               I guess related to that then is this underlying
     concern that has sort of been alluded to already, that a
     performance based structure really can only respond to
     failure and a viable regulatory structure needs rather to be
     conservative enough to ensure public safety.
               I think that some of viability criteria that seek
     to integrate some of the comments that have been raised
     previously actually do address some of these concerns, and
     yet I am left wondering if they could actually then be
     usefully applied to any waste scenario, particularly with
     respect to high level waste and spent fuel, and if not, if
     all of the waste scenarios would basically be ruled out,
     according to these viability standards then I am wondering
     in what sense and why are these guidelines being proposed as
     high level.
               Thank you.
               CHAIRMAN GARRICK:  Thank you.  Are there any other
     comments?
               [No response.]
               CHAIRMAN GARRICK:  All right.  Well, thank you
     very much.
               MR. KADAMBI:  Thank you, Mr. Chairman.
               DR. HORNBERGER:  Amazing time management by the
     Chairman.
               CHAIRMAN GARRICK:  I think this brings us to a
     point in our agenda where we adjourn for lunch.
               [Whereupon, at 12:16 p.m., the hearing was
     recessed, to reconvene at 8:30 a.m., Wednesday, July 26,
     2000.]

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