ML20237E153

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Transcript of 980825 Public Meeting in Rockville,Maryland Re Briefing on 10CFR70 PRM, Revised Requirements for Licensing of Special Nuclear Material. Pp 1-102.Supporting Documentation Encl
ML20237E153
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Issue date: 08/25/1998
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NRC COMMISSION (OCM)
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REF-10CFR9.7 NUDOCS 9808280287
Download: ML20237E153 (131)


Text

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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION

Title:

BRIEFING ON 10 CFR PART 70 PROPOSED RULEMAKING, " REVISED REQUIREMENTS FOR LICENSING OF SPECIAL NUCLEAR MATERIAL" --

PUBLIC MEETING Location:

Rockville, Maryland r

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Date:

Tuesday, August 25,1998 l

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Pages:

1 - 102 l

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00 ANN RlLEY & ASSOCIATES, LTD.

1025 Connecticut Avenue,NW, Suite 1014 Washington, D.C.20036 (202) 842-0034 l

98d8280287 980825

.7 PDR l

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DISCLAIMER This is an unofficial transcript of a meeting of the United States Nuclear Regulatory Commission held on August 25, 1998, in the Commission's office at One White Flint North, Rockville, Maryland.

The meeting was open to public attendance and observation.

This transcript has not been ceviewed, corrected or edited, and it may contain inaccuracies.

The transcript is intended solely for general informational purposes.

As provided by 10 CFR 9.103, it is not part of the formal or informal record of decision of the matters discussed.

Expressions of opinion in this transcript do not necessarily reflect final determination or beliefs.

No pleading or other paper may be filed with the Commission in any proceeding as the result of, or addressed to, any statement or argument contained herein, except as the Commission may authorize.

1 1

UNITED STATES OF AMERICA 2

NUCLEAR REGULATORY COMMISSION 3

4 BRIEFING ON 10 CFR PART 70 5

PROPOSED RULEMAKING, 6

" REVISED REQUIREMENTS FOR DOMESTIC 7

LICENSING OF SPECIAL NUCLEAR MATERIAL" 8

9 PUBLIC MEETING 10 11 Nuclear Regulatory Commission 12 Room 1F-16 13 One White Flint North 14 11555 Rockville Pike 15 Rockville, Maryland 16 Tuesday, August 25, 1998 17 18 The Commission met in open session, pursuant to 19 notice, at 10:00 a.m.,

the Honorable SHIRLEY A. JACKSON, 12 0 Chairman of the Commission, presiding.

. 21 '

22 COMMISSIONERS PRESENT:

23 SHIRLEY A. JACKSON, Chairman of the Commission 24 NILS J. DIAZ, Member of the Commission 25 EDWARD McGAFFIGAN, JR., Member of the Commission ANN RILEY & ASSOCIATES, LTD.

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1

2 1

STAFF AND PRESENTERS SEATED AT THE COMMISSION TABLE:

2 JOE CALLAN, EDO 3

TOM BAER,-NFS 4

JACK ALLEN, Westinghouse 5

CHARLIE VAUGHAN, GE 6

JOHN C. HOYLE, Secretary 7

KAREN D.

CYR, General Counsel 8

JAMES TAYLOR, Executive Director for Operations:

9 DR. CARL PAPERIELLO, NMSS 10.

ELIZABETH TEN EYCK, NMSS 11 RICHARD MILSTEIN, NMSS 12 13 14 15 16 17 18 19

'20 21 22 23

,24 25 ANN RILEY & ASSOCIATES, LTD.

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\\

1 PROCEEDINGS 2

(10:00 a.m.)

3 CHAIRMAN JACKSON:

Good morning.

Today we are 4

going to be focusing on the staff's proposed revisions to 10 5

CFR Part 70, and we have several industry representatives 6

who have come to provide their views regarding the proposed i

7 changes to Part 70.

l 8

Following their presentation, the staff of the NRC l

9 will brief the Commission on the details of its proposal for 10 revising the requirements for the domestic licensing of 11 special nuclear material found in 10 CFR Part 70.

12 The process to revise Part 70-began in 1993, and 13 various aspects were presented to the Commission for 14 resolution in 1996 and 1997.

Today, my colleagues and I 15 look forward to hearing from all presenters to assist us in 16 resolving issues associated with the draft rule that is 17 presented in SECY 98-185.

18 And so unless my colleagues have any remarks they 19 would like to add at the moment, Mr. Fertel, I assume you 20 are going to lead off.

If you could introduce your 21 colleagues.

22 MR. FERTEL:

I will.

Thank you, Chairman Jackson, 23 and good morning, Commission McGaffigan, Commissioner Diaz.

24 I am Marvin Fertel of the Nuclear Energy 25 Institute, and I am certainly pleased to be here today to ANN RILEY & ASSOCIATES, LTD.

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represent not only NEI, but all of the fuel fabrication and

i 2

enrichment companies that operated facilities licensed under 3-10 CFR Part 70.

4-With me at the table this morning at Dr. Tom Baer, 5

who is the VP for Safety and Regulatory Activities at

-6 Nuclear Fuel Services; Mr. Charlie Vaughan, who is the 7

Manager for Strategic and Regulatory Planning at General 8

Electric; and Mr. Jack Allen, who is the Plant Manager for 9

the Westinghouse Columbia facility.

And I think with the 10 expertise sitting with me here, hopefully, we will be able 11 to answer any questions that you might have from a safety, 12 regulatory, or operational perspective as this dialogue goes 13 on.

14 I would also like to point out that there are 15 representatives from all the fuel fabricators and enrichers 16 present today in the; audience.

17 On behalf of the Nuclear Energy Institute's 18 Facility Operations Committee, I would like to thank you for 19 the opportunity to appear before you again to discuss the

-20 ongoing rulemaking to amend 10 CFR Part 70.

21 As you are aware, we have been working for several 22 years, and Chairman Jackson mentioned 1993, which makes it 23 at least five years right now, with the NRC staff to develop 24 a set of modifications to Part 70 which would improve the 25 regulatory process and enhance protection of the public

)

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health and safety at our facilities without imposing 2

unnecessary burdens on industry or the NRC.

3 Prior to receiving SECY 98-185, the staff's most 4

recent draft rulemaking package, we believed that we were 5

making reasonable progress in closing the gap between the 6

staff's perspectives and our own.

We had planned to present 7

to you today a sense of significant progress and to identify 8

those few important issues which remain for resolution.

9 We have not yet fully digested all of the detail 10 in the very extensive rulemaking package.

It is voluminous 11 and involves many new and complex concepts such that making 12 it difficult for us at this time to make informed judgements 13 as to its implications in a single rulemaking.

14 For example, within the SECY there are new 15 requirements and criteria governing worker safety, new 16 reporting requirements, new decign criteria for new 17

. processes or facilities, new provisions for the conduct of 18 preliminary ISAs, new procedures for licensee changes, and 19 new criteria related to criticality safety.

Any of these i

20 concepts in and of itself could justifiably be the subject 4

21 of an individual rulemaking proceeding.

22 We have, however, performed a sufficient review of 23 SECY 98-185 to conclude that much of the progress we thought 24 had been made was illusory.

That, (2), the rulemaking i

25 package, particularly the draft standard review plan, is a ANN RILEY & ASSOCIATES, LTD.

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6 significant departure from how we understood our rulemaking 1

2 petition was being dispositioned.

(3) If implemented using 3

the proposed SRP, the rule will focus many industry and 4

staff resources away from significant safety issues.

And 5

(4), the package deviates from the guidance provided with 6

the Commission in its August 22, 1997 SRM.

7 We cannot hide our sincere disappointment with the 8

package we received.

To understand our concern, it is 9

important to recount some of the history of our interactions 10 on this issue.

11 CHAIRMAN JACKSON:

Let me stop you for a moment, 12 Mr. Fertel.

13 MR. FERTEL:

Yes, Chairman.

14 CHAIRMAN JACKSON:

Can you be more explicit in 15 terms of what respect or respects do you feel the proposed 16 rule differs from the guidance?

17 MR. FERTEL:

Yes, I can.

And I will in here, but 18 the primary area where it does that is the staff has 19 included a significant amount of prescriptive, programmatic 20 safety criteria.

21 CHAIRMAN JACKSON:

Is that in the rule or in the 22 documents?

23 MR. FERTEL:

It is in the SRP.

It is the Standard 24 Review Plan.

25 CHAIRMAN JACKSON:

Standard Review Plan.

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MR. FERTEL:

Yes.

2 CHAIRMAN JACKSON:

Yes.

l 3

MR. FERTEL:

It is not in the rule itself, but it 4

is in the SRP.

And that is the one major area where we 5

think it deviates.

We think that another area is they are 6

consistent with the guidance offered by the Commission, 7

though we request that the Commission, maybe after we 1

i 8

finish, consider whether or not you want to offer them new 9

guidance in a couple of areas.

So they are not totally 10 inconsistent with the guidance in the SRM, but they clearly 11 are, in our opinion, on the imposition of major programmatic i

12 safety requirements.

13 CHAIRMAN JACKSON:

And you are going to talk in 14 more detail about those?

15 MR. FERTEL:

Yes.

16 CHAIRMAN JACKSON:

Okay.

17 MR. FERTEL:

The last time we appeared before the l

18 Commission, on July 2, 1996, we expressed strong concern 19 regarding the existing draft Part 70 revisions, as well as l

20 the draft standard format and content guide and the standard 21 review' plan.

22 One of our most significant comments was that the 23 rulemaking package, including the format and content guide 24 and the SRP contained a large number of new programmatic j

25 criteria.

Those domiments contain new guidelines for NRC i

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review and approval of our various safety programs in areas I

2 such as quality assurance, maintenance, training and 3

criticality safety.

4 Many of those guidelines went well beyond existing 5

programs and were not, in our view, Justified on the basis 6

of health and safety.

Up until our July 2nd meeting with 7

you, the industry had argued that no changes in Part 70 were 8

necessary.

On July 2nd we modified our position and 9

embraced the staff proposal to require the performance of 10 integrated safety assessments.

I think they call them 11 integrated safety analyses now.

12 We concluded that by adopting the ISA, the safety 13 basis of the facilities would be more clearly defined.

The 14 licensee's and the NRC's attention would be focused on the 15 most important safety issues, and it would provide for 16 implementation of a graded risk-informed, performance-based 17 safety program.

18 In embracing the ISA concept, however, we urged 19 the Commission to eliminate the references to these new 20 multiple safety programs as premature and unnecessary.

We 21 believe that a rule should be written to require the 22 performance of ISAs and to require licensees to modify their 23-

' plants and activities to address any vulnerabilities t

24 identified as a result of those ISAs.

25 Our rulemaking petition proposed to implement this i

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approach, but we concluded that promulgation of a wide range' 2

of.new prescriptive safety program criteria would not be 3

part of the rulemaking package.

4 In SECY 97-137, the staff discussed its proposed 5

disposition of our.rulemaking petition and stated that, "In 6

response to licensees'. concerns, staff is now proposing 7

that, rather than require multiple safety programs, 8

licensees have the flexibility to determine, based on the 9

ISA results, the specific elements of the safety programs 10 that would be needed."

11 The Commission's SRM dated August 22, 1997 12 approved the staff proposal to revise Part 70, as requested 13 by the NEI petition, with the modifications described in 14 SECY 97-137.

On that basis, we assumed that the current 15 rulemaking package would focus on the ISA and on the need to 16 address vulnerabilities identified in the ISA, but would not 17 contain a wide range of new prescriptive. safety program 18 criteria.

19 CHAIRMAN JACKSON:

. What are you calling -- are you 20 calling -- what are you calling -- give us some examples of 21 what you are calling --

22 MR. FERTEL:

In the SRM itself, Chairman Jackson, 23 there is at least the expectation, from the experience that 24 we have in dealing with the regulatory process, that if I

.l, 25 identified a particular'high risk safety system in my ANN RILEY & ASSOCIATES, LTD.

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facility, that as the reviewer here looked at what I should*

2 be doing for it, they would, in OA-1, which is what they are 3

including in the SRM and the SRP, they would require me to 4

use a systematic approach to training, which may or may not 5

be appropriate or that case.

And they would basically have 6

prejudged the nature of the QA, the training program and 7

other programs that I should be using for a high risk l

8

-system.

9 What we would'have expected, and I think that 1.

10' maybe the staff would say this would still happen, but these 11 are the words that they have in the SRP.

l 12 CHAIRMAN JACKSON:

I guess what I am really trying 13 to make sure I. understand is, are you -- is your fundamental 14 point that there are a number of additional prescriptive 15 requirements in the standard review plan that go beyond the 16

.ISA?

Or are you talking about the ISA itself.

I just want 17 to be' clear.

18 MR. FERTEL:

We are talking about prescriptive 19 program requirements in the standard review plan that would 20 be applied if my ISA identified a high risk system, or 21 prodess, or activity.

So we are actually okay, in general, 22 on how the staff wants to do ISAs.

We have a problem with 23 whether the ISA goes in the license or not.

But as far as 24 how to actually do an ISA, I think that that is an area 25 where the industry and the staff have made very good ANN RILEY & ASSOCIATES, LTD.

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progress and are, basically, in very good agreement.

2 It is when I finish doing it and I determine ther.

3 this class is a high risk class, and I am now sitting down 4

to say, okay, am I treating it correctly within my plant 5

operation and program space as far as the way I am training 6

Charlie to operate it, or I am looking at the QA program 7

that I am putting on it.

We would say we ought to look at 8

that, we ought to come up with what makes sense, and it may 9

or may not be a systematic approach to training approach in 10 this case.

It may or may not be in QA-1.

It likely 11 wouldn't be in our mind in many cases.

12 But right now, if I look at the SRP, the test, the 13 hurdle, would be, okay, how are you applying in QA-1 to that 14 particular class?

How are you applying your systematic 15 approach to training to that class?

16 CHAIRMAN JACKSON:

So, I mean is the problem i -

17 having to do with the degree of prescription in terms of how 18

.to resolve a vulnerability or address a vulnerability?

19 MR. FERTEL:

I think that is an appropriate and 20 correct characterization of the problem.

21 CHAIRMAN JACKSON:

Okay.

.2 COMMISSIONER McGAFFIGAN:

Just to follow-up on 2

23 that, going back to this point as to whether the ISA is in 24 the license or not, it also is who is in charge of the 25 process of figuring out how to respond, right?

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want us second-guessing every judgment, as I understand it, 2

or every engineering change that you make that might be l,

3 above a 50.59 threshold.

And so it is a question of, if it 4

is not in the license, if you do the ISA, you respond to it, 5

you are responsible for doing that much, but if -- but we 6

are not second-guessing every judgment you make in response 7.

to your ISA.

8 MR. FERTEL:

Yeah, I think that's accurate, too, 9

Commissioner, that we don't want you second-guessing.

Now, 10 we certainly do want you to approve those particular actions 11 that you should approve and we are not at all opposed to 12 license conditions that would make all the'ISA information 13 available.

I think the problem with the ISA and the license 14-is.it is adding, you know, thousands of pages'o'f material, 15-and, in many cases, lots of material that -- you know, how 16 do you sort through-to find out what is important as part of 17

.your license, and it is an administrative nightmare for 18 handling.

These facilities, when you go visit them, 19 thousands of pages.

l 20 CHAIRMAN JACKSON:

Well, let me just understand.

21 Is the rub, with respect to this' specific issue, an 22-administrative one, or is it that you are concerned that it i

23 triggers' requirements?

Because, presumably, if you have to 24.

do an ISA, you know, as a condition of getting a license,

)

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updated and so on, because if it is not, it is useless, a,ll '

)

i 2

of that is going to occur anyway.

And if there are 3

thousands of pages associated with it, there are thousands 4

of pages associated with it.

5 But, so I guess I really want to understand, is A

6 the fundamental rub an administrative issue, or i t is that 7

you are concerned about requirements that may be triggered 8

as a consequence?

9 MR. FERTEL:

It is both.

And administrative is 10 probably making it sound too trivial.

It is not so much 11 administrative and Xeroxing another thousand pages, because 12 that certainly can be done.

What it is, is if I am going to 13 keep it up to date as part of my license, and every time 14 have to make a decision whether it is a license amendment, 15 whether or not that is really important or not, if I am 16 going to have to implement a 50.59 equivalent process for 17 these facilities, which they have never had, nor seem to 18 need, am I creating something that, again, diverts, in this 19 case, relatively limited resources at these facilities?

20 CHAIRMAN JACKSON:

No, I understand the point you 21 are making.

But are you -- you are not arguing that it 22 should not be updated?

23 MR. FERTEL:

Absolutely not.

And we are not 24 arguing that it shouldn't be available.

We think it

- 25 definitely should be available.

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CHAIRMAN JACKSON:

And so the real question has to1 2

do with mechanism?

3 MR. FERTEL:

Yes.

4 COMMISSIONER DIAZ:

It can be docketed but it is 5

not part of the license, that is what you are saying?

It 6

can be an available --

7 MR. FERTEL:

Certainly available, and certainly 8

used.

And we don't have any problem with using it, even in 9-enforcement space, correctly.

We are just trying to keep it 10 simple.

11 CHAIRMAN JACKSON:

Well, as simple as the 12 complexity of it allows.

All right.

Okay.

13 MR. FERTEL:

Let me see, I'll pick up somewhere 14 and skip a couple of things.

15 Okay.

In addition to the problem that we have 16 raised with the-apparent imposition --

17 CHAIRMAN JACKSON:

Excuse me.

18 COMMISSIONER McGAFFIGAN:

There was one other.

question I meant to ask on this slide that you were on, the 19

-20 history of interactions.

In 1996, in July of

'96, it sounds 21 like at that point there was a standard review plan that you 22 all had access to and that you didn't like, and there was a 23 Commission, before my time, and you had discussion.

24 There are now, in this SECY document, you have 25 seen the new standard review plan, and apparently, that, 4

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again, is causing great concern.

2 What, in that intervening two-year period, what 3

was the nature of the interaction on the standard review 4

plan?

Did it evolve?

Did you all have some insight into 5

it?

e 6

You know, as a general matter, I'll tell you where 7

I am coming from, in the reactor. space, we seem to work best 8

when these guidance documents are discussed back and forth 9

between NEI and the staff in public.

FSAR update, we now

(

{

10 are relying on 98 -- NEI 98-03 as the basis for, hopefully, 11 resolution there.

We are hoping to do similar things in l

12 other reg. guides.

l 13 But in this case, from '96 to a few days ago, or a 14 week ago, had you seen the SRP?

j l

l 15 MR. FERTEL:

We hadn't.

From '93 to '96 there was t

l 16 a lot of interaction between the industry and the NRC on l

17 development of the standard review plan that evolved to that 18 point.

NRC held a number of open meetings where the 19 industry.came in and made presentations on draft sections of 20 the SRP.

And I think during all those meetings, there was a 21 consistent drumbeat, at least from our side, that you are 22 getting too prescriptive and back off.

And what came out in 23 the '96: time frame, when we appeared before the Commission, 24 was, well, we hadn't won those arguments and it was still j,

25 there.

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From '96 till now, the real focus of the 2

discussion has been on the other issues of where should --

3 How do you do an ISA?

What do we think about, you know, 4

what is an ISA?

And, again, there was very good agreement 5

that has been reached there.

What type of criteria should 6

you have for the radiation side?

And I think there has been 7

very good agreement there.

8 And we didn't get very good agreement on where the 9

ISA should go, whether it is in the license or not, but 10 there was a lot of discussion.

We had a lot of discussion 11 on the applicability of the backfit rule.

We did not see 12 the SRP until this SECY was released, nor did we discuss it.

13 CHAIRMAN JACKSON:

Let me make sure I understand, 14 though, you know.

So that you have had open interactions.

15 MR. FERTEL:

Very much so.

16 CHAIRMAN JACKSON:

It is just that the open 17

-interactions have no focused on the SRP.

18 MR. FERTEL:

That's correct.

19 CHAIRMAN JACKSON:

Okay.

20 MR. FERTEL:

And it may have been erroneous on our 21 part to assume that the SRP was going to end up absent some 22 of these things.

And I think maybe that was why the 23 visceral reaction when we saw it was not good.

24 CHAIRMAN JACKSON:

Okay.

So, I mean -- because 25 there is an implication that there was a deliberate attempt ANN RILEY & ASSOCIATES, LTD.

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to keep you from seeing the SRP.

2 MR. FERTEL:, I have no basis for that, that was 3

just the process.

4 CHAIRMAN JACKSON:

It is just the process that you 5'

6 MR.-FERTEL:

Yes.

7.

CHAIRMAN JACKSON:

You were interacting.

8 MR. FERTEL:

Very much so.

9 CHAIRMAN JACKSON:

It is just that the SRP was not 10 the focus of most of'those interactions,-is that correct?

11 MR. FERTEL:

Yes, i

12 CHAIRMAN JACKSON:

You were going to make a 13 comment.

14 DR. BAER:

No, that was correct.

15 CHAIRMAN JACKSONi Right. 'Okay.

)

16 MR. FERTEL:

Yeah.

In addition to the problem.

L 17 that we do have with the programmatic requirements, which 1

i 18 are related to the SRP, we continue to have disagreements l

l 19 with the staff on the proposal on whether to include the ISA

,j 20 results in a license, their opposition to the inclusion of 21

~ an immediately effective backfit provision and the inclusion 22-of consequence criteria that focus on purely chemical 23 hazards, and we are going to talk some more about all of

-24' thests.

25

. Based on that, we have concluded that the proposed ANN RILEY & ASSOCIATES, LTD.

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1 rulemaking package is substantially the same as the prior, 2

draft to which we objected back in 1996, even though, again, 3

I would say that on the ISA, we are clearly in much more

~

4 agreement than we ever were, and even in the radiation 5

criteria.

6 As the Commission is moving to improve and 7

simplify its regulatory process overall, we believe the 8

proposed Part 70 rulemaking package would significantly 9

increase both complexity and burden on the licensee, and the 10 NRC.

It would do so for facilities that have an excellent 11 safety record, and really pose extremely low public health 12 and safety risk.

And we believe there is simply no need for 13 dramatic change in the Part 70 regulations.

14 ISAs should be conducted and licensees should be 15 required to correct any vulnerabilities that may emerge.

16 The ISAs should be kept up to date, and the NRC should --

17 CHAIRMAN JACKSON:

Let me ask you a question.

18 What would be the basis of that requirement?

19 MR. FERTEL:

We would support a license condition 20 that says I must have an ISA.

We would support a license 21 condition that tells us that we must keep it up to date.

We 22 would support a license condition that says it must be 23 available for inspection and review by NRC.

24 CHAIRMAN JACKSON:

You are taking all of this 25 down, right?

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(Laughter.]

2 COMMISSIONER McGAFFIGAN:

That much -- do you need 3

a new rule for?. Or could we, under the existing Part 70, 4

just say these license conditions will be expected when

)

5 somebody renews a license?

And just put them into a 6

document that says when you review future --

i 7

CHAIRMAN JACKSON:

It is not an explicit 8

regulatory requirement, so_you would have a question-in 9

terms of --

~10 MR. FERTEL:

You would have that question.

I 11; mean, not wanting to beat it to death, but I mean the staff 12 has been imposing those as conditions of every license t

13 renewal.

So Chairman Jackson is correct, but, clearly, the 14 process works in other ways.

15 And, again, I think, Commissioner McGaffigan, a 16 simple rule'would probably legitimatize what is going on in 17 practice, which, in most cases, we are honestly willing to l

18 support.

l 19 COMMISSIONER DIAZ:

Is this -- it would work l

20 something like, you know, the maintenance rule in a certain 21 way, maintaining configuration control, but without having 22 to keep, you know, the process at every step, very, you L

j 23 know, scrutable, but you have to comply with it, you have to

24 make sure that information is available so the staff can 25 check that you actually --

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MR. FERTEL:

I think that is not a bad analogy,,

2 Commissioner Diaz.

3 MR. VAUGHAN:

No, in fact, that is very good, 4

because at the operating level, the operator has to 5

understand what the configuration is to manage their 6

operation.

And we have indicated time and again that, at 7

the sites, that information would be available for the NRC 8

either to review or inspect, or whatever their desire is.

9 COMMISSIONER DIAZ:

So those requirements express 10 for your facilities -- that requires that you maintain, 11 according to the ISA, the configuration management would

.12 actually maintain the safety aspects of your facility and be 13 scrutable.

14 MR. FERTEL:

Yes, very much so.

Again, I don't 15 think in philosophy, we are really at odds with even the 16 staff.

I think that it is in implementation mechanisms and 17 processes, and I think that the Commission is offering 18 suggestions that are very consistent with ways that we would think you could implement.

Because we are not arguing 19 20 against any sort of accountability here, or using the ISA 21 appropriately.

That is"not in debate on our side.

22 CHAIRMAN JACKSON:

Okay.

23 MR. FERTEL:

In support of the proposal that the 24 staff has put out, they discuss incidents, many of which 25-have been, in our opinion, mischaracterized at operating ANN RILEY & ASSOCIATES, LTD.

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21 1

facilities, and all of which have occurred years ago.

2-Maybe most important is they don't adequate 3

account for the changes that have occurred in the 4

intervening years.

While the Part 70 regulations themselves 5

have not.substantially changed, the rigor of their I

6' implementation has substantially increased.

And I think 7

this goes to Commissioner McGaffigan's statement that, in 8

essence, a lot of this is already happening, though maybe l

9 the rule doesn't give it all the regulatory legitimacy it f

10 should have.

11 A wide range of NRC st'aff initiatives undertaken 12 under the existing rules, including enhanced cr;ticality, j

13 safety reporting, more rigorous inspections and updated 14 guidance on management oversight and chemical safety have i

15 increased the NRC's focus on chemical hazards, fire 16

-protection and nuclear criticality safety.

These are the 17 concerns which originally prompted calls for amending the 18 regulations.

19 Beyond this, during the last license renewal i

20 cycle, most Part 70 licensees agreed, as a condition of 21 their license, to perform an ISA on a set schedule.

The 22 acceptance of an ISA condition demonstrated that both the

23 NRC and the.NRC recognize the valuable tool an ISA can be.

24 Furthermore, industry initiatives have resulted in 25 a fuel fabrication industry that is safer than it was ten f

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years ago.

Those initiatives include improvements in the 2

level and quality of documentation of nuclear criticality f

3 safety analyses, improved configuration management programs 1

4 and better unusual event identification and root cause 5

analysis.

6 Together, the staff and industry initiatives have 7

resulted in better understanding of plant safety bases and 8

more rigorous application of programs important to safety 9

within the current Part 70 regulations.

10 COMMISSIONER DIAZ:

Excuse me.

The term " safer" 11 just caught my eye and ear.

Would you elaborate on that?

12 How much safer is safer?

Can you give me a ballpark?

13 MR. FERTEL:

It would have to be qualitative.

I 14 think that in almost all the facilities, Commissioner Diaz, 15 what has happened is the rigor at look root cause analysis 16 has gotten much better.

The configuration management 17 control systems have gotten much better.

18 The implementation of 91-01 as a reporting 19 mechanism has helped share across the industry, maybe more 20 effectively, information.

So it is more of a qualitative, 21 because we are not quantifying.

22 And I think, you know, my background is much more 23 reactors than the Part 70 licensees, and it took me a while, 24 sitting with my friends here, and various meetings, to 25 understand the nature of their risk, and they very different ANN RILEY & ASSOCIATES, LTD.

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23 1

than reactor risks.

It is really hard to cause something 2

off-site.

So when we are talking safer, it is safer in

-3 avoiding any type of event, not a health and safety threat.

4 COMMISSIONER DIAZ:

Besides the difference in the 5

absolute, you know, between reactors.

And is this -- have i*

6 the improvement in the fuel facilities comparable, start 7

with, you know, lower safety regs to those that have been 8

made in the reactor side?

(

9 MR. FERTEL:

I would tend to say yes.

I mean 10 there's a lot more rigor at the reactor sites and things l

11 like PSAs, and, you know, just the nature of the beast that l

12 you are working with.

And event here, you know, it's hard l

13 to say as,.you know, the bar keeps getting raised.

14 COMMISSIONER DIAZ:

Okay.

15 MR. FERTEL:

I don't know if anybody here at the l

16 table, Jack, or Tom, or Charlie, would like to say

'17 something.

18 DR. BAER:

Commissioner, it is very difficult to l

19 have a dramatic improvement in something that is already at 20 a safety level where incremental changes cause, on a l

l 21 percentage basis, large amounts.

At our facility, there are 22 essentially no accident sequences that would produce a 23 significant off-site impact.

So we are already starting l

24 below the limits that have been set in the regulations.

25 COMMISSIONER DIAZ:

I understand that.

I was ANN RILEY & ASSOCIATES, LTD.

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referring to the fact that if configuration management and 2

all of the other processes have increased in quality and 3

effectiveness, you know, as they have in reactors, that even 4

your very safe levels will be at a much higher level of 5

safety.

And I was questioning what those. improvements are, 6

and I am really not familiar.

7 MR. VAUGRAN:

I think from the operating plant 8

standpoint, I can't compare it to rectors because I don't --

9 you know, I am not qualified to do that, but in our 10 businesses, I think the lessons that we have learned in the 11 last few years, and have tried to implement, one of those is 12 the lesson of configuration management.

And you have to 13 have configuration management to keep your programs in tune.

14 And we have made lots'of changes in that regard.

And, also, 15 kind of as a spin-off of that, or a result, there has been a 16 lot of improvement in the internal documentation that 17 describes your basis for safety and what is important to 18 assure that those protective measures are in place.

19 I believe the next milestone, if you want to go 20 farther than what we have pretty much done voluntarily, is 21 22 CHAIRMAN JACKSON:

Let me take you up on the issue 23 of voluntarily.

The question is what drove the changes.

24 And I mean it seems like I heard a combination of things, 25 industry initiatives, more rigorous implementation of the ANN RILEY & ASSOCIATES, LTD.

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existing Part 70, and lessons learned on both the industry l

2 and the agency side in terms of learning from incidents and 3

so on that occurred over the years.

And so it strikes me 4

that it seems to be a kind of a potentiating thing, that not 5

all of these were just totally voluntary from the beginning.

6 MR. VAUGHAN:

Yeah, you are correct.

There's a 7

lot of interaction.

But we learned a number of lessons from 8

what was happening at our plant, and there was a sensitivity 9

driven by the NRC to those kinds of things. So it was clear 10 that we needed to learn the lesson.

And the inspection 11 program continues to point out places that we miss the mark, 12 and we take that very seriously and learn from those, too.

13 So it is an interactive process, 14 COMMISSIONER McGAFFIGAN:

Could I ask what has the 15 trend been in 91-01 reports?

In the 96 document, 16 attachment, there apparently was a downward trend, and I was 17

. wondering whether that had continued in 97, in 91-01, you 18 know, the reports that you all voluntarily, or whatever, 19 submit in response to the information notice.

20 MR. ALLEN:

I would say that from the Westinghouse 21 experience, that they are increasing, that there is more 22 involvement, more reporting as we have gone through various 23 situations, and I think it is because of the interactions, 24 that it has not truly been voluntary in some respects and it 25 has been int'eractive.

So there's -- I would say that it has ANN RILEY & ASSOCIATES, LTD.

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been an increase.

2 COMMISSIONER McGAFFIGAN:

But does 91-01, I have 3

not honestly read the bulletin, does it -- are these 4

precursor type reports that you have to report on, cnr does 5

that mean the number of precursors is increasing?

Or does 6

it just mean that you are getting down and finding more?

7 MR. ALLEN:

I think it is the latter, in the case I think we are being more deliberate about the license 8

9 requirements, understanding the license requirements, the 10 timing of reporting and the specifics.

In some cases it 11 goes to the point of the prescriptiveness of some of the 12 requirements that we are talking about.

I think that is 13 what has driven a lot of the reporting.

14 I would just like to also comment that in the case 15 of our customers and the quality requirements, there are --

16 in QA-1, there are iSA requirements.

It is not 17 prescriptive, and yet we have enhanced our quality systems 18 and work closely with our customers, and you have in 19 regulating them, done the same.

20 And so back to what Commissioner Diaz was talking 21-about, in terms of an improvement in safety, I would say 22 that the improvement in safety that we have seen is 23 commensurate with the enhancement in the product quality.

24 And so we have seen that kind of level of improvement that 25 has been generated.

And so those are the two points I would t

[

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make relative to prescriptive improvements.

2 MR. FERTEL:

Tom, do you want to say anything in 3

response to Commissioner McGaffigan's question on 91-01?

4 DR. BAER:

It's not a fair comparison for at NFS, 5

because two years ago we were not operating.

Today we are 6

operating.

We have made a couple of 91-01 reports.

We 7

don't believe that it is an indication of precursor.

It 8

means it is because we are looking very closely at the 9

operations and what we have.

And we have used the 91-01 10 process to help us identify things, and that view, that 11 process has helped us to be more rigorous in our own 12 approach.

13 CHAIRMAN JACKSON:

Let's go on.

14 MR. FERTEL:

I think just the last point which is 15 relevant to maybe the discussion we just had is that all the 16 NRC license performance reviews at the fuel fab facilities 17

.over the last couple of years have confirmed the safety of 18 the operations there, and I think that it is an evolving and 19 maturing thing as maybe you do reporting under 91-01.

20 Clearly, we endorse safety enhancements that are 21 achievable at reasonable cost to the industry and the NRC 22 and which are commensurate with the safety benefits.

We 23 don't believe that costly major regulatory changes are 24 required and we have said that since 1996.

And we view the 25 new programmatic criteria set forth, primarily in the draft l

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SRP, as costly and unnecessary.

And on that basis alone, we' 2

have a problem with supporting going forward with the rule 3

as currently written, if it is supported by that SRP.

-4 CHAIRMAN JACKSON:

So it is really the SRP that is 5

the big rub?

6 MR. FERTEL:

That is clearly the eye-opener when 7

we began to look at it, in all honesty, and we talked about 8

this yesterday a bit, that the package is really pretty 9

voluminous.

And we have problems with the regulation of 10 purely chemical hazards, which we will talk about.a bit, and 11-we think we should have some discussion on, and we have the 12 problems that we carried over on how the ISO -- ISA, I'm 13 sorry.

I am thinking of the system operators these days.

14 The ISA, whether it is in the license or not.

15 But the thing that caught our attention was the 16 imposition of what looked like just a monstrous set of 17 programs that, again, may or may not be appropriate.

And 18 that's only a question.

We are not saying we would never do 19 those.

What we are saying is they shouldn't be just 20 prescriptively imposed.

21 We believe that our approach -- sorry.

22 CHAIRMAN JACKSON:

Oh, no, no.

23 MR. FERTEL:

We believe that our approach provides 24 the necessary improvements to the regulatory process 25 contained in the staff proposal, at far less cost.

We are I

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29 1

concerned that the cost estimates contained in SECY 98-185 2

substantially underestimate the burden on both industry and r

3 the NRC.

4 Our basis for that concern is the experience of at 5

least one licensee, and keep in mind, there aren't very many 6

in this particular community, where as much as 70 percent of 7

the ISA is completely and where there is actual cost data 8

available.

The cost greatly exceeds the regulatory analysis 9

estimate.

10 We also base our opinion on experience in recent 11 license renewal proceedings in which the staff has 12 prematurely, and maybe inappropriately, applied the guidance 13 set forth in the draft SRP as licensing standards.

Aside 14 from our concern with the rulemaking itself, this is a 15 practice which we would strongly disagree with, and one 16 which highlights, in our opinion, the need for a backfit 17 provision, which Tom will talk about in a minute.

18 What I would like to do now is have Tom Baer talk 19 about some of the specific issues that we had thought we 20 would be raising before you today until we saw tue SRP, 21 which sort of changed our tack a little bit, but it is 22 probably the ones that the staff also felt that we and they 23 were in somewhat disagree on coming into this meeting.

And l

24 I think that while there is that disagreement, those l

l-25 discussions have been constructive, though maybe not l

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conclusive.

2 DR. BAER:

Good morning, Chairman Jackson, 3

Commissioner McGaffigan, Commissioner Diaz.

The first topic

~

4 I will be discussing is the inclusion of the ISA results in 5

our licenses.

6 After extensive discussion with the staff, we have 1

7 not been able to reach agreement on the inclusion of ISA 8

results in the license.

The staff believes that the results 9

or output from the ISA process should be physically 10 incorporated into the Part 70 facilities licensees.

The 11 draft proposal is not appropriate because it creates an 12 excessive burden in managing extensive information, much of 13 which is~ commercially sensitive, requires significant 14 administrative support and focuses significant NRC and 15 licensee resources away from safety at the facilities.

16 CHAIRMAN JACKSON:

Let me ask you this, if the ISA 17 were to be docketed, had to be maintained, were used as part 18 of regulatory decisions, tell me where the cost comes in so 19 I can really understand between whether it is in the license 20 or not in the license.

21 DR. BAER:

It is back to what can we change once 22 something is in the license.

23.

CHAIRMAN JACKSON:

Okay.

24 DR. BAER:

So if I go to make minor changes in my 25 plant --

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CHAIRMAN JACKSON:

So it is the change process and' 2

how onerous.it is if it is in the license.

3 DR. BAER:

It essentially eliminates our ability 4

to make minor modifications to the plant.

5 CHAIRMAN JACKSON:

So let me understand.

So the 6

point is really it is the change process for it if it is in 7

the license versus not being in the license.

Is that what 8

you are basically --

9 DR. BAER:

That is a major part of it, yes, ma'am.

10 CHAIRMAN JACKSON:

Okay.

Okay.

11 DR. BAER:

It is not necessary because the 12 information is available at the plants in the proper 13 context.

The information is not necessary for the NRC to 14 exercise enforceable authority.

15 CHAIRMAN JACKSON:

Let me ask you this, if the ISA 16 were available in the plants, but not to the licensing 17 staff, which is here, how would the process work in terms of 18 if there were some need to evaluate it relative to some 19 change in the license or change in the plant?

20 DR. BAER:

We have had several visits from the 21 licensing staff to come to our facility and have looked at 22 the detailed documents we have provided.

23 CHAIRMAN JACKSON:

So you are talking about not t

24 docketing it at all.

25 DR. BAER:

Not docketing the entire ISA, but, ANN RILEY & ASSOCIATES, LTD, Court Reporters

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1 certainly, we would consider docketing, certainly, a 2

summary, docketing the_results.

The summary information 3

would certainly address those items that are safety 4

significant, but a complete ISA addresses literally 5

thousands of scenarios,.many of which are not safety 6

significant.

7 COMMISSIONER McGAFFIGAN:

Could I -- I am just 8

trying to tie down.

The staff and the SRP talk -- shows a 9

model license application and the level of detail that they 10 expect enrapturing the results of the ISA.

And you don't 11 want to do that in the license and have that incorporated in 12 the license.

But what they describe in the SRP in the way 13 of results, is that level of detail that you would imagine 14 docketing?

Or is that -- is that excessive, what they are 15 asking for in the SRP even to be docketed?

I am trying to 16 tie down --

'17 DR. BAER:

The level of detail that they ask for 18 in the example is beyond what most licensees had anticipated 19 docketing.

20 COMMISSIONER McGAFFIGAN:

Okay.

21 MR. ALLEN:

I would also add that another part is, 22 in addition to the change process, the commercial 23 sensitivity of some of the.information, Each of us runs 24-different processes.

25 CHAIRMAN JACKSON:

I understand.

l l

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33 1-MR. ALLEN:

So what we are down to is writing two 2

versions, one for public consumption and one for the 3:

license.

And so that becomes an onerous part of the 4

management'of it.

5-MR. FERTEL:

Just maybe to add one point, Chairman 6-Jackson.

You had mentioned in a change process, how would 7

the licensing staff, if they'didn't have it, do things.

I 8

don't think anybody envisions not submitting sufficient 9

information on a change that requires NRC approval to the

.10 licensing staff, but you would. submit the information that 11 was relevant to that change as part of whatever ISA analysis 12 you may have done, et cetera.

13 CHAIRMAN JACKSON:

Now, is there a need, though, 14 to have clarification on that as part of either, if it is 15 not the SRP, the rule itself?

Because I do know there is, 16 you know, a historical issue having to do with back and 17

.forth requests for additional information.

The staff feels 18 it needs certain things.

The licensee either.doesn't have 19 it or doesn't want to submit it, and that causes a kind of 20 do loop.

And so then, you know, either this Commission or a 21 successor Commission could be sitting around hearing 22 complaints about RAIs back and'forth.

23 And so, you know, you try to fix one problem and 24 you end up with another one.

And so there really needs, to 25 me, to be some clarification on this issue of how you handle

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_-________ _ - _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ __ _ - _ _ = _ _.

34 what is needed.to make these kinds of decisions.

1 2.

I appreciate what you talk about in terms of 3

commercial sensitivity and what may be in the public domain 4

particularly.

But I do believe this issue of what 5

information the licensing staff would need, you know, should

'6 the need arise, and how that is to be obtained is a 7

non-trivial issue, because you don't want to -- because you

~8

-- and so at'the same time I am appreciative of this issue 9

of not having an overly onerous change process.

But there 1

10 has to be some middle ground, you know, somewhere between 11 the two extremes, because the NRC staff does have to have 12 information to do its job.

13 DR. BAER:

Yes.

And we recognize that and we want 14 them to have all the information necessary to make good 15 decisions.

16 MR. ALLEN:

And,.in fact, have participated in 17 this process where each of our sites has been visited to i

18 discuss the content, format and the process for handling 19 ISAs.

So we have been very interactive and just would like 20 to extend that to resolve these issues.

21 MR. VAUGHAN:

Chairman Jackson, I just wanted to 22 say that I think you are on a very important point there.

23 And there probably does need to be some clarification.

It

.24

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35 1

giving their inspection people, because it seems like 2

programmatic approval might come at the licensing stage and 3

then confirmation and confidence is developed through 4

inspection.

So I think you hit on-a very good point there.

5 CRAIRMAN JACKSON:

Well, that's true except when 6

they are changes to the licenses because'of major changes to 7

a-facility.

And that -- I mean so it is not that the 8-licensing staff acts once and then from then on it is 9-strictly inspection.

You know, and I don't know, you all 10 know more about the facilities than, obviously, we do.

But 11 at some point, you know, there are issues that do propagate 12 back into licensing space.

And so -- and that is really 13 what we are talking about here.

14 Yes.

15 COMMISSIONER McGAFFIGAN:

I am going to stay on 16 this theme of changes that require our approval.

At the 17 moment is it clear in Part 70 what changes at the facilities 18 19 CHAIRMAN JACKSON:

Do require.

20 COMMISSIONER McGAFFIGAN:

-- do require our 21 approval?

And then, how big a difference would it be 22.

compared to the proposed rule, which as I understand it has l

23 a 50.59 type provision where we would capture.all these 24 results of our ISA, and then if it is more than minimal 25 increase in safety or any new event, you all would have to ANN RILEY & ASSOCIATES, LTD.

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36 1

come in for a license?

I am just trying to understand, 2

whatever the credere are today, how many amendment change 3

requests do we get?

And under the new rule, how many change 4

requests are we likely to get?

5 MR. VAUGHAN:

Part 70, now, I don't believe 6

addresses that particular subject, but --

7 CHAIRMAN JACKSON':

Should it?

8 MR. VAUGHAN:

In our licenses, we have sections in

'9-our license that address that.

The only problem that we see 10 there is the fact that the conditions are not always the 11 same, and maybe they shouldn't be.

But I mean there's a 12 variation.

13 COMMISSIONER DIAZ:

We agree with that.

14 CHAIRMAN JACKSON:

Well, but that is the question.

15 I mean if.it is license-specific, should it be?

And if it 16' shouldn't'be, should that be something that is addressed 17 here in terms of how, you know, what triggers?

18 MR. VAUGHAN:

I personally I think you can handle 19 it either way you want to.

You sometimes have a little bit 20 more flexibility -- I mean you regulate a number of 21 different licensees, not just us, and so if you look at the 22 larger picture, it might be better off to do it in licenses, 23 because that way you could tailor it to the particular kind 24 of license you are working with.

On the other hand, if you 25 want to treat everybody exactly the'same, then you write it ANN RILEY & ASSOCIATES, LTD.

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into the regulation.

2 COMMISSIONER McGAFFIGAN:

One of the problems we 3

run intol reactor space, as you know -- or you probably don't 4

know, is treating everybody exactly the same sometimes gets 5

us into trouble, because we are alleged to be ratcheting 6

people down to the werst performers.

7 CHAIRMAN JACKSON:

Yes, but at the same time, 8

treating everybody not the same also gets us into trouble.

9 COMMISSIONER McGAFFIGAN:

Right.

Right.

10 CHAIRMM1 JACKSON:

We are alleged to be 11 inconsistent and so that's --

l 12 COMMISSIONER McGAFFIGAN:

It depends which 13 stak'eholder-you are listening to at the particular time.

14 CHAIRMAN JACKSON:

It depends on the particular 15 situation.

16 COMMISSIONER McGAFFIGAN:

But, okay, back to my 17 question.

You all have license conditions.

In the license 18 conditions at the moment, you know when you have to come in 19 for a license amendment.

That is fairly clear from the 20 license condition, not the rule, when you have to come in 21 and say this is a change that requires NRC approval, is that 22 correct?

23 MR. VAUGHAN:

We feel like it is, yes.

24 COMMISSIONER McGAFFIGAN:

Okay.

How many do you 25 have today and how many do you envision you would have to 4

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have under this 50.59 rule, or like rule that we are 2

building into the new rule?

I mean how -- you if you make 3

changes in your facility every year, how many would likely 4

have to come to us under the new rule?

5 MR. VAUGHAN:

I am not sure, because there is not 6

exactly -- it is not like a routine thing, it is just when a 7

change comes up, and sometimes you will have several in one 8

year, and then you may go the better part of a year without 9

anything significant.

So it doesn't seem to have a pattern.

10 But under the new approach, if you go down to the 11 level of requiring the ISA in the license and all of the 12 items relied on for safety in the license and all of that, 13 we, at our facility, process, and I imagine the others are 14 about the same, process about 800 facility change requests a 15 year.

So 800 times in a year you are going to have to make 16 this decision about whether you have to come get an 17 amendment or not.

And the requirements, as are being 18 proposed, are tight enough that some amount of that 800 are 19 going to have to come to the Commission.

So -- and I just 20 can't you how many that is.

21 COMMISSIONER McGAFFIGAN:

But just to get back to 22 the moment, there's 800.

I am trying to tie down the 23 changes, 800 a year approximately.

At the moment there is 24 some significance test in your license condition and you i

25 recognize it when you see it.

I mean you don't have an

)

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elaborate process to decide whether each of these 800 f

2 changes require an NRC -- whether there is unreviewed safety 3

question that would then require a license amendment with l

4 us, but you know it when you see it, so it must be a very j,

5 small subfraction, a handful per year, zero, it sounds, some l

6 years, of the 800 that fit the criterion in your license l

7' amendment.

8 You are saying the new rule will impose a process 9

where you have to look at each 800 document why you didn't 10

-- why it is not an unreviewed safety question and why it 11 doesn't breach this minimal threshold.

12 MR. VAUGHAN:

Right.

Right.

t 13 COMMISSIONER McGAFFIGAN:

And then a much larger 14

fraction, you are judging will have to come to us for prior 15 approval.

16 MR. VAUGHAN:

Right.

If my memory serves me 17 right, for example, we have had two such cases that we had 18 to come to licensing in the last year.

19 COMMISSIONER McGAFFIGAN:

Two out of 800, 20 approximately.

21 MR. VAUGHAN:

Yes.

22 COMMISSIONER McGAFFIGAN:

Okay.

l 23 MR. ALLEN:

But there is a rigorous process.

24 There is a very deliberate process in each of our facilities 25 for managing those process changes.

And so there is a ANN RILEY & ASSOCIATES, LTD.

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scrutiny of those 800 and it is a documentation process, and' 2

it undergoes a formal review.

So I don't want to leave you 3

with the thought that there is not that type of scrutiny in 4

our facility.

5, CHAIRMAN JACKSON:

Right.

But I am guess what I 6

am trying-to understand is the -- are you saying that the 7

way the rule, as~it is currently' structured, that it would 8

end up causing you to have a more onerous process for, you 9

know, deciding when to come -- whether something has to come 10 to'the NRC?

11 MR. ALLEN:

I don't think it would be more onerous 12 in deciding what to come.

I think it would be more 13 decisions to come for a formal license change as opposed to 14 the process.

15 CHAIRMAN JACKSON:

I see.

So it is changing a 16 threshold?

17 MR. ALLEN:

That's correct.

18 CHAIRMAN JACKSON:

Okay.

19 DR. BAER:

The draft proposal, we believe does 20 little to improve facility safety, places NRC prescriptive 21 requirements on the licensee, and would require major 22 license -- major amendments to our license by requiring that 23 potential accidents, items relied upon to prevent or 24 mitigate such accidents, and the measures to assure that 25 those items are available and reliable, all to be included ANN RILEY & ASSOCIATES, LTD.

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41 l

1 in the license.

2 We agree that all of this information resulting j

3 from the conduct of the ISA process must be retained, used 4

by the licensee to manage the facility, and made available 5

for NRC licensing reviews and inspections.

l 6

The proposed requirement to which we object is to 7

include all of this detailed information in our license 8

applications and, ultimately, our licenses.

The staff's 9

approach would dramatically expand the description of the 10 plant site, facilities, equipment, processes and controls.

11 Including this level of detail in our licenses is not l

12 necessary for the staff to conduct effective inspection and l

13 enforcement activities.

To our knowledge, the NRC has never 14 required this type of information to cite violations when 15 they are warranted.

16 Furthermore, it would represent a significant 17 administrative burden for the licensees and the staff, 18 producing little measurable improvement and safety, and 19 diverting finite resources away from safety programs.

20 Our concerns in this regard are heightened by our 21 initial review of the staff's example of an ISA submittal 22 included in SECY 98-185, which suggests a level of detail 23 beyond what we had anticipated t believe to be appropriate.

24 The Commission should recognize that most of the Part 70 l.

25 licensees already have committee to performing ISAs and have 1

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42 1-those efforts well underway.

Substantial rework would be 2

required if the staff's approach was adopted.

l 3

The staff's objectives can be achieved without 1

4

. incorporating the detailed ISA results into the licenses.

5 Under NEI's approach, the regulation would require that we 6

include in our licenses, binding commitments to prepare and 7

maintain the ISAs, identify potential accidents, identify 8

the items relied on for safety, and maintain controls to 9

assure that those items are available and reliable.

Through 10 these simple license conditions, the NRC would have the 11 ability to inspect and. verify that ISAs are properly 12 performed and updated as facility changes are made, items 13 relied on for safety are identified, and appropriate 14 measures are maintained to ensure the availability and 15 reliability of such items.

16 Under our approach, the ISA results and 17

. documentation would be fully available for NRC staff 18 licensing reviews and inspections.

Enforcement action could 19 be taken for non-compliances with the rule, including 20 failure to perform an adequate ISA, failure to make 21 necessary plan or program changes or failure to maintain 22 those changes.

23 Thus, the benefits of the proposed amendments to 24 Part 70 can be realized if the rule requires the simple 25 license commitments we have proposed.

We believe this ANN RILEY & ASSOCIATES, LTD.

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43 1-approach is moving toward the Commission's risk-informed, 2

performance-based regulations.

3 Now, turning to the backfit rule.

Our next 4

concern involves the application of the backfit provision.

5 In NEI's rulemaking petition, we propose that a backfit 4

6 provision be included in Part 70 and that it should apply as 7

soon as the other Part 70 rule changes become effective.

8 The staff has proposed only to consider including 9

such a provision in Part 70 several years from now, after 10 the ISAs are complete, the results are incorporated into our 11 licenses and experience is gained with implementation of the 12 ISA requirement.

Under this approach, a wide range of 13 costly new requirements, many of which are set forth in the 14 draft SRP, could be imposed without any site-specific l

15 consideration of whether they are needed for compliance or i

16 are justifiable on a cost benefit basis.

I 17 The staff previously proposed delaying the 18 effectiveness of a backfit provision in another context, the 19 certification of the gaseous diffusion plants under 10 CFR 20 Part 76.

We have provided the history of the NRC's 21 decision-making process on that provision on our White Paper 22 on the Part 70 regulation.

23 We call to your attention to that history because 24 we believe that it clearly chows that the Commission

[

25 directed the staff to apply Part 76 backfit provision as 1

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soon as Part 76 became effective, but the staff ha not done 2

so.

The NRC certification of the gaseous diffusion plants, I

l 3

without the benefit of a backfit rule, has resulted in 4

millions of dollars in plant program and procedure changes l

5

-at these plants, many of which may not have been justifiable 6

under the backfit rule.

That experience strongly suggests 7

to us that inclusion of an immediately effective backfit 8

provision in Part 70 is essential and is consistent with l

9 past Commission directives.

The addition of the new 10 programmatic criteria beyond the content of the rule clearly l

11 demonstrates the need for an operative backfit provision.

l l

12 The next issue I will discuss --

i 13 CHAIRMAN JACKSON:

Yes, go ahead.

14 COMMISSIONER McGAFFIGAN:

Could I ask on this, 15 because I am one of the problems for you all on backfit?

I 16 took down fairly carefully something Mr. Fertel said a few l

17

. minutes ago, that the industry supports safety enhancements 18 achievable at reasonable cost.

My problem with the backfit 19 rules is they proliferate in our legislation, Part 76, Part i

20 50, is that that isn't the test.

It isn't safety 21 enhancements achievable at a reasonable cost.

There is a 22 first -- that is in there, but first you have to have, and I 23 am reading it, a substantial increase.

So a small increase l

24 for a minimal cost or a trivial cost, under the backfit 25 rule, as I read it in Part 50 or Part 76, even, although you

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45 1

say it has been waived there, I am not allowed to do that.

2 Small -- because it has to be a substantial increase in 3

safety in order to even consider it.

4 So I am open to backfit it if it were the Marvin 5

Fertel backfit, supporting safety enhancements achievable at 6

reasonable cost.

But the backfit where you start with this 7

test that there has to be a substantial increase, not just a 8

good increase or whatever, that's where -- that's.the 9

problem I am having with backfit.

Because as I said in my 10 vote, and you know, you have seen my vote on the previous 11 paper, that substantial increase test, at times, I think, 12 prevents us from doing reasonable things at trivial cost.

13 And so, you know, if you are open to the wording of the 14 backfit rule, then you may find a somewhat more responsive 15 Commissioner.

But this one you shouldn't blame the staff-16 for because I am at least one of the people who has --

17 CHAIRMAN JACKSON:

Guilty.

18 COMMISSIONER McGAFFIGAN:

-- urged the staff to go 19 in this direction.

20 (Laughter.)

21 CHAIRMAN JACKSON:

Guilty as charged.

22 MR. FERTEL:

Maybe, Commissioner McGaffigan, we 23 should look at it maybe in three tests.

I mean there is

]

24 clearly the test of, is it a safety enhancement that is 25 required from the standpoint of satisfy either regulatory or i

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l 46 1

true, you know, risk standpoint?

And I don't think there is' i

2 any question that NRC can impose that and licensees should 3

fulfill their obligation there.

4 I think then there is sort of the fork in the road 5

that you are going down, which is I am an operator and there 6

are some relatively inexpensive enhancements I can make that 7

get me some good, though not maybe not substantial, safety 8

improvement.

I think that operators will do that if they 9

make sense, and it shouldn't be a regulatory imposition.

10 Because, again, we are -- in a reactor space now, we are 11 looking very hard at how should we do assessment of reactors 12 in a way that really builds risk-informed information into 13 it and creates some sort of assessment process where you 14 really do have different areas of regulatory involvement, 15 including some areas of just regulatory oversight and no 16 imposition potentially.

17 I think that that is, again, where you want to 18 stay out of areas where, gee, NRC thinks this is a good 19 thing, but it really isn't a substantial increase for the 20 dollars.

I think that that is a point where it is beyond 1

21 the regulatory requirement for protection of public health 22 and safety.

It may be something the operator wants to do 23 and should do, and maybe we would find they would do it more l

24 often if they didn't think it would become a regulatory 25 requirement.

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So I mean I think my advocacy would be to apply

'2 the backfit provision systematically, the way the rule says 3

it should be. applied, and you may find this sort of gray 4

area in between true regulatory requirements and true 5

backfit requirements being done maybe more at.the 6

prerogative of' licensees in some cases, or not, but still 7

not diminishing safety.

I mean you are still well above the 8

safety threshold from a regulatory standpoint, or a safety 9

margin from a regulatory standpoint.

So I guess I would 10 maybe argue that you could get more of what you want if the 11' backfit provision was implemented in a more rigorous way, as 12 currently written in 51.09.

13 COMMISSIONER'McGAFFIGAN:

Okay.

Well, I think 14 there is.more than a semantic issue there, and we can 15 continue the discussion.

16 CHAIRMAN JACKSON:

Why don't we move along?

17 DR. BAER:

The next issue that I will discuss this 18; morning involves the proposed consequence criteria.

We are 19 pleased that SECY 98-185 includes criteria which generally 20 agree with those we had proposed in our petition.

The ISAs 21 would evaluate potential event sequences against such 22.

criteria and identify the items relied on to provide 23 reasonable assurance that such criteria will not be 24 exceeded.

25 However, the SECY appears to be proposing specific ANN RILEY & ASSOCIATES, LTD.

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consequence criteria governing concentrations of various.,,

2 non-radiological chemicals that have nothing to do with the 3

safety of nuclear materials.

This suggests to us that 4

licensees could be cited with violations for exceeding 5

purely chemical exposure levels.

6 As we read the proposed rule, if the established 7

chemical exposure levels are exceeded, a licensee would be 8

required to institute controls to prevent or mitigate those 9

exr'tures.

In fact, the proposed rule will require 10 re fort:eng of purely chemical exposures to the NRC.

11 While purely chemical exposure levels can be used 12 in the ISA process for determining whether those exposures 13 could affect the safety of license materials, they should 14 not themselves be used as consequence criteria.

The 15 proposed rule would establish an unnecessary system of dual 16 regulation between the NRC, EPA and/or OSHA.

17 CHAIRMAN JACKSON:

Well, you know, as you point 18 out here, that NRC and OSHA operate under a MOU.

19 DR. BAER:

Yes.

20 CHAIRMAN JACKSON:

And so I will ask the staff, in 21 terms of their criteria, how that plays off against the MOU 22 and.whether, in fact, it has caused a problem.

Does OSHA 23 regularly inspect your facilities?

24 DR. BAER:

We, at our facility, have been 25 inspected within the last year by the Tennessee OSHA.

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CHAIRMAN. JACKSON:

Okay.

2 COMMISSIONER McGAFFIGAN:

I might just follow up.

3 You say here in your viewgraph it conflicts with the 4

NRC/ OSHA MOU.

That isn't as clear to me, as I read the MOU.

5-We are not supposed to -- it says NRC inspectors are not to 6

perform the role of OSHA inspectors.

But then it also says 7

that they are going to be trained in order to enhance the 8

ability of NRC personnel to identify safety matters under 9

OSHA per view.

OSHA will provide NRC regional personnel 10 with basic chemical and industrial safety training.

And 11 then it says that they will -- that NRC/ OSHA joint team 12 assessments are going to be carried out..Each agency will 13 make its best efforts to support such assessments at about 14.

20 facilities once every five years.

15 As I understand it, we obviously do that.

OSHA, 16 because of budged constraints, oftentimes doesn't.

So what 17 we have here is an awkward situation where we have some 18 responsibility under a MOU.

We are not OSHA, but we have 19 some responsibility to identify issues.

And OSHA doesn't 20 have the capability to, or the personnel resources to 21 inspect as often.

So how much of that should be capture or 22 not capture in our regulatory space in order to be honorable 23 under the MOU is the issue.

24 So it wasn't -- it isn't as clear to me that it 25 conflicts with the MOU.

It may be an effort by staff to ANN RILEY & ASSOCIATES, LTD.

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carry out de facto what has been going on under the MOU.

2 MR. FERTEL:

I think that we would appreciate the 3

fact, to some degree, NRC's in-field folks are eyes and ears 4

for OSHA' and that is why the training is going on, and that 5

probably makes good sense in this cooperation and avoidance 6

of duplication of effort by federal agencies.

That's good.

7 I think the concern that we have is the way both 8

the rule is written, in this case, as well as the SRP 9

information.

It appears that NRC is going to regulate and 10 enforce pure chemical hazard requirements.

Not chemical 11 hazards that relate to nuclear materials.

We understand 12 that that --

13 CHAIRMAN JACKSON:

Dr. Paperiello is shaking his 14 head no.

15 MR. FERTEL:

I hope he is shaking it that -- he is 16 shaking no, that they don't intend to do that.

I would love 17 to be corrected on this.

18

[ Laughter.)

19 MR. FERTEL:

I can't see Carl.

20 COMMISSIONER DIAZ:

But let me understand, in the 21 relative worth of each item, how big is this issue compared 22 to the ones we have been talking about?

I mean is the 23 inspection and reporting of chemical hazards as important to 24 you as what you have been talking about?

Or is it a 25 relatively small issue compared to the rest?

(

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CHAIRMAN JACKSON:

Do you want us to fix this, but**

'2' have the ISA in the license?

3

[ Laughter.].

4 MR. FERTEL:

Can I get a few more choices?

5 (Laughter.)

6 MR. FERTEL:

I want to know all the options before 7

I choose.

I think, Commissioner Diaz, let me try and answer 8

this maybe a little bit differently than you posed the 9

question.

I think this is almost a no-brainer for the 10 Commission.

Because it is outside of the purview, and I 11 would assume that Karen would offer whatever legal opinion 12 she would have on it.

But I think that pure chemical hazard 13 is truly outside the purview'of the NRC's regulatory 14 requirements, so it ought to be an easy one, not requiring 15 trade-off with some of the others.

16 And, again,.if Carl was shaking his head no, I 17 would love to stand corrected on this and have him say that 18 was not:the intent.

19 CHAIRMAN JACKSON:

Not wanting to cut you off, but 20

.we have used most of the time, and we will have the panel to 21 hear from.

22 DR. BAER:

-I have got a third of page, and then 23 back to Marv for about a page.

l 24 Finally, I would like to point out that the 25 proposed rulemaking package contains a number of new t

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concepts that were not part of previous discussions and not 2

part of the staff's proposed disposition of our rulemaking 3

condition as approved by the Commission.

These concepts 4

include, among others, the introduction of design criteria 5

for new Part 70 facilities or for new processes at existing 4

6 facilities.

It requires new reporting requirements and a 7

new provision for the conduct of preliminary ISAs prior to 8

construction of new facilities or processes.

These new 9

concepts, among others, warrant careful review before they 10 are included in a proposed rule.

11 Now, I will turn the floor back over to Mr.

12 Fertel.

13 MR. FERTEL:

The facility operations committee and 14 the facility operators would like to move forward with a 15 rulemaking that would aid in further enhancing both the Part 16 70 regulatory process and in assurance of adequate public 17 health and safety at the facilities.

18 SECY 98-185, however, with all of its 19 complexities, does not provide the basis for doing so, nor 20 does it meet all of the guidance in your 1997 SRM.

NEI 21 requests that the NRC reconsider our petition and adopt a 22 rule.that requires licensees to conduct ISAs using accepted 23 techniques, where I think we do have agreement; requires 24 licensees to document the results of those ISAs and to make 25 those results available for NRC review and inspection; and ANN RILEY & ASSOCIATES, LTD.

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53 1

directs licensees to identify and. correct vulnerabilities 2.

identified through the ISA process; and ensures that 3

controls established those vulnerabilities are maintained.

~

4 We continue to believe that this simple approach, 5

couplad with an immediately effective backfit provision, and 6.

we will have more discussions with Commissioner McGaffigan, 7

twould provide a sound a cost effective basis for further 8

enhancing safety at licensed Part 70 facilities.

And the 9

SRP should not be adopted in its present form, nor used on 10 an ad hoc licensing and inspection basis in the interim.

11 We recognize that the staff proposal does comport 12 with some of the guidance provided by the Commission in the 13 1997 SRM.

In-this regard, we ask that the Commission 14 consider issuing new guidance to the staff that reiterates 15 your direction regarding the elimination of new prescriptive 16 programmatic requirements, that addresses the regulation of 17

. pure chemical hazards, and that you reconsider your position 18 on the ISA and the license, and the timing and 19 implementation.of the backfit provision.

20 We, again, appreciate the opportunity to appear 21

'before you-today.

We remain committed to working with the 22 staff and the Commission towards resolution of the issues we 23 have raised and we would be pleased to answer any other 24 questions you have.

25 CHAIRMAN JACKSON:

Well, you know, Commissioner ANN RILEY & ASSOCIATES, LTD.

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McGaffigan has advertised his position on the backfit issue.

l 2

I am going.to advertise something to you, and this has to do 3

with this issue of documenting or docketing of the ISA and 4

what results are available for NRC review and inspection.

I

~

5 do not believe it is acceptable to try to fix one problem, 6

and this is separate than -- I mean, because I think the 7

issue can be addressed separately or, you know, we can deal 8

with the issue whether the ISAs, the full ISAs need to be a 9

license.

But it is not that you solve it by saying, well, 10 we have it hear, and if you want it, come and get it, kind 11 of thing.

And so I think you need to think through whether 12 there'is some middle ground with respect to this issue of 13 how'much information and where it is.

Because, again, we 14 don't need to have it be overly onerous for you, but, at the 15 same time, the agency has to be able to have what it needs 16 to have for its decision making.

And so I am just saying 17 that'is my point of view.

Yes.

18 COMMISSIONER McGAFFIGAN:

I would like to ask a 19 question about this preliminary ISA concept.

As I 20 understand it, and, obviously, I have only heard about it in 21 the last few weeks myself, this is partly motivated by the 22 potential for some DOE facilities to come under our purview, 23-the tank waste remediation project up at Hanford, the MOX 24 facility if it comes under our regulatory purview, et 25 c e t e r e..

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And, indeed, I know in the text of something I,,

2 have seen, I think a White Paper, you all say that this is 3

not a problem for your facilities.

But there is some-4 historical evidence that is a problem for DOE.

There's a 5

famous Rocky Flats plant that closed before opening because 6

it was misdesigned from a criticality perspective.

7.

So how -- you know, the problem we have is that 8

Part 70 may be a document that will be used, if it is 9

revised, for both the existing well-established facilities 10 that you all represent and how a framework for dealing with 11 these complex DOE facilities, where some of these 12 criticality issues are going to be much for difficult.

And 13 so the preliminary ISA, you know, may force them to think 14 through in DOE space, and their contractors, some issues 15 where there is, as I say, there's at least some historical 16 evidence that DOE didn't do well.

How do you respond to 17

.that?

18 MR. FERTEL:

Well, again, I think in the l

19 regulatory space.nat you are looking al, Commissioner, what 20 you ought to du is maybe separate the two.

For one thing, 21 these licensees have been licensed by NRC for 30 years now I

22 probably.

And while they didn't have an ISA for all that 23 time, you know, they were licensed.

They have all gone 1

24 through license renewal, one is completing it now, and NRC 25 found fit to find them safe to keep operating.

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The ISA, by its nature, is living document.

I am 2

not quite sure I even know what a preliminary ISA is, to be 3

completely honest with you, given the living nature of the 4

document.

So you would do the best job you can with the 5

best information available, and you would continue to use 6

that document, both at the plants and in regulatory space.

7 If there's unique aspects of the DOE situation, I 8

guess my encouragement would be write a separate section, 9

even if it is under Part 70, that allows you to make that 10 distinction and. impose different. sets of steps in the 11 process maybe for DOE facilities coming in.

But maybe you 12 can't mix it all together in the same bowl, you know, right 13 now.

14 MR. ALLEN:

I think just to add quickly to this, 15 and it is scary to me because I have seen, within our own 16 facility, the escalation of administering these 17 requirements.

But in one of our discussions over the last 18 several days, I heard a number where a process change in a 19 facility was proposed to have several thousand pages of 20 documentation and approximately six man-years' worth of work 21 to be required for that process change, and it now almost 22 four-fold the number of people and ten times the amount of 23 documentation.

And that is scary for a process change.

24 So I think what we are really suggesting is that 25 we need to work together through this so that we don't ANN RILEY & ASSOCIATES, LTD.

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create a Rocky Flats similar situation, but we recognize 2

that the ongoing nature of our facilities, which have been.

3 licensed for 30 years, really needs to be taken into 4

account.

So I would just echo what Marvin has said and 5

recognize that we want to work through this together.

6 MR. VAUGHAN:

Yeah, a couple of more points on 7

that, if.I can.

One thing is we have been licensed for 30 8

years, but up until recently we had to redemonstrate safety 9

at every five year renewal.

Now, I know the five years got 10 a little longer, but at a relatively frequent periodic 11 cycle, we had to completely redemonstrate safety for our 12 facilities.

13 The other thing is our facilities have to operate 14 and operate efficiently and cost effectively, and so, 15 therefore, when we consider modifications or changes to the 16

' facility, we have to be satisfied that we are protecting the 17 stockholders and that the mission we are on is one that will 18 proceed successfully.

So there are'some differences between L

19 our segment and DOE, for example.

20 CHAIRMAN JACKSON:

Well, let me make one comment, 21 which actually may sound like it agrees with Commissioner

-22 McGaffigan.

[ Laughter.]

23 l

l 24 CHAIRMAN JACKSON:

But let me assure you it is 25 purely coincidental.

You know, I appreciate what you are ANN RILEY & ASSOCIATES, LTD.

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58 1

saying about the fact that your facilities have operated 30 2

years.

And that, you know, what we put into place ought to 3

make sense relative to the safety of those facilities.

4 At the same time, at any given time, the 5

Commission has a responsibility to decide what the baseline 6

needs to be.

And so it is not a linear no-threshold model 7

that everything goes to zero.

You know, there will be some 8

baseline.

It has to be risk-informed, et cetera.

So that's 9

number one.

10 Secondly, and this is where I touch base with what 11 Commissioner McGaffigan talked about within the context of 12 DOE, but let's leave DOE aside.

I mean at the moment you 13 have your 30 year old facilities.

The real question 14 becomes, you know, one could say, will there never be 15 another fuel facility created or licensed?

And what then, 16 in terms of kind of a regulatory framework should exist that 17 allows us to deal effectively and fairly with you, but that 18 doesn't necessary require us to go down a new rulemaking 19 path each time there is potentially a new facility being 20 potentially licensed?

And so I think that is the kind of 21 the issue, to me, at the heart of it.

22 And whether -- and I appreciate what you say, that 23 perhaps for DOE, if we go down that path, there may be a 24 need to have some segregation of some of the kinds of' 25 requirements.

But there always is this embedded issue of ANN RILEY & ASSOCIATES, LTD.

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1 what kinds of regulatory fabric can be the living regulatory' 2

fabric that allows us to accommodate existing facilities, 3

but that doesn't always make us have to create a new rule if

~

4 there is a new facility.

But I understand the point you are J

f 5

making.

1..

I 6

Commissioner Diaz.

7 COMMISSIONER DIAZ:

Just a comment.

This is not

'8 advertising, there might be another exception.

9 I am concerned about the fundamentals of what we i

10 are talking, and let me see if I understand it.

There seems 1

L 11 to be agreement on the ISA.

Everybody seems to like the j

12 ISA.

And if that is true, I think the bottom line is make 13 this living ISA a functional document that allows you to 14 manage your plant according to the safety requirements that 15 the Commission imposes.

That means some communications, 16 some ability for us to determine that you are carrying out 17 your configuration management with adequate intrusion but 18 not maximum intrusion.

And the problem is how we do that.

j 19 And I think one of the issues that has been raised j

20 is how much you put as part of the license or not.

And I 21 think that is what we need to get, you know, real clear y

l 22 feedback from you and from the staff, because I think that 23 is the bottom line.

24 CHAIRMAN JACKSON:

Thank you very much.

'25 MR. FERTEL:

Thank you very much.

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CHAIRMAN JACKSON:

We will now hear from the NRC l

2 staff.

Mr. Callan, why don't you begin?

3 MR. CALLAN:

Good morning, Chairman, 4

Commissioners.

With me at the table this morning are 5

Elizabeth Ten Eyck, who is the Director of the Division of 6

Fuel Cycle Safety and Safeguards; Carl Paperiello, who is 7

the Director of NMSS; and Richard Milstein, the Project 8

Manager for the Part 70 effort.

9 Elizabeth Ten Eyck will be our primary briefer, 10 but before I turn the discussion over to her, I would like 11 to have Carl Paperiello make a few opening comments.

12 DR. PAPERIELLO:

I want to -- I would like to just 13 talk about the process, and Liz will talk about the rule.

14 The staff is extremely sensitive to the release of j

15 pre-decisional information without explicit Commission 16 direction.

So in all our interactions with the industry on I

17 the rule, we never gave them text.

We came -- we talked 1

18 about everything and what was in it, but they were never 19 given text.

And a lot of the discussions were on the rule 20 and very little on the --

)

21 COMMISSIONER McGAFFIGAN:

Can I --

j 22 CHAIRMAN JACKSON:

Let him finish his sentence.

23 Let's 90.

1 24 DR. PAPERIELLO:

It was not on the standard review 1

25 plan.

And I want to step back.

Standard review plans, I

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traditionally, have been not constraints on licensees but 2

constraints on individual reviewers to ensure uniformity of 3

1 3

the process.

Because we do that, prescriptiveness creeps 4-in, because we are putting the constraints on what the 1

h reviewer is allowed to accept to ensure that reviews done by

)

5 4

6 different reviewers achieve the same' result.

l 7

It was clear to me when I took over NMSS, where we 8

had very poor standard review plans, that we had to update 9

them, and also they were de' facto constraints on the l

10 applicants So I made the decision that in the future all 1

11 NMSS standard review plans would be issued in draft and wo 12 would get public comment on them.

13 Now, for those standard review plans for which 14 there is not an associated rulemaking, they are old rules 15 and things like that, that is an ongoing process.

We have 16 been revising all of these things and getting public input.

l 17 When we had a standard review plan provided as part of the l

18 rulemaking, it still is pre-decisional, and without explicit 19 Commission direction, we have never put these out in the 20 public domain for comment, and that is where we stand right 21 now.

(

22 We changed in Part 35, based on the proposal we 23 made to the Commission, everything was done on the web.

In 24-the future, since NMSS is now responsible for all its 25 rulemakings, we will probably always propose to you, that is i

?

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the way we do, but the situation we have right now, this is I

2 the first time this standard review plan went out for, you l

3 know, for the review.

I guess there's -- well, I am 4

bothered by the bit of an implication that there was bad I

5 faith on the part of the staff, and we didn't try to do l

6 that.

7 CHAIRMAN JACKSON:

Let him finish that paragraph, 8

then it's all yours.

9 COMMISSIONER McGAFFIGAN:

I am not --

10 CHAIRMAN JACKSON:

Are you done?

11 DR. PAPERIELLO:

Yes.

12 COMMISSIONER McGAFFIGAN:

-- accusing bad faith.

13 What I believe is, though, that we would be better served.

14 I mean I have actually been citing, as Joe Callan knows, to 15 Joe,.why can't we -- why can't NRR be more lik'e NMSS in the 16 way we did Part 35, the way the decommissioning guidance was 17 out on the web, even as we were voting on it and giving you 18 final guidance on how to deal with the decommissioning 19 guidance for the decommissioning rule.

20 And I think that that is a better process.

I 21 think it leads to better results.

And so if your intention 22 in the future is to use that process, that is fine.

I 23 didn't imply -- these gaps occur all the time around here.

24 It happens in reactor space all the time, where we go 25 pre-decisional and we can't talk about it until it is before ANN RILEY & ASSOCIATES, LTD.

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the Commission, _and we end up having train wrecks.

And we 2

would be better'off having the documents -- we are not, to 3

my knowledge, we are not having any train wrecks in Part 35 4

partly because we have --

5 CHAIRMAN JACKSON:

Right.

But I think you are 6

both right.

Okay.

But I think we ought not to spend our 7

time talking about what did or didn't happen.

I do not 8

believe the staff operated in bad faith.

You realize that 9

the staff has traditions in terms of how it operates that 10 are based on previous Commissions and how they wanted to do 11 things.

If this Commission wants to do things differently, 12 then it has the prerogative to do that and to give the staff 13 that guidance.

And so, you know, I think you have a 14 situation where the Commission made a deliberate decision,

~

15 together with the staff, on Part 35.

16 Perhaps it should have thought more broadly at 17 that time on other rulemakings.

It did not.

We are where 18 we are.

It is out for public comment, and that is the

-19 opportunity to make changes as appropriate, and I think that 20 is where we ought to take it up and not spend more time 21 talking about the process, you know, other than how we might 22 change in on a go forward basis, and talk about the content 23 of the rule.

Okay.

24-MS. EYCK:

Thank you.

Good morning.

We would L.

25

.like to discuss our Part 70 activities included on the ANN RILEY & ASSOCIATES, LTD.

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viewgraph and overview.

Since members of the Commission 2

have changed since we first started this effort, we would 3

like to provide a small background of how we got to where we 4

are today.

We will identify some of the weaknesses in the 5

current Part 70.

We will discuss the approach that we have 6

taken in developing this rulemaking package.

And we will 7

describe the major elements that are contained in the 8

proposed Part 70.

9 Next slide, please.

I'm sorry, we can -- yes, 1

10 next slide.

11 For background, in 1986, a worker was killed at 12 Part 40 license facility based on a chemical hazard, 13 hydrogen fluoride, that resulted from the result of UF6.

14 And in 1991, we had a near criticality accident at a 15 licensed -- a Part 70 licensed facility.

And after that, 16 staff and other activities and other organizations started 17 to reexamine the fuel cycle safety program to identify 18 weaknesses with the program.

19 A review by the House Committee on Government 20 Operations criticized NRC for being a paper tiger, too 21 narrowly focused on radiological hazards and not enough on 22 non-radiological hazards such as chemical and fire.

And 23 quoting from their report, they made a comment that said, 24 "The Committee must conclude that deficiencies in NRC's l

25 regulatory program for the licensing and inspection of fuel l

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facilities were also a major contributing factor to the l

2 accident."

This is the death of the individual at Sequoia i

3 Fuels.

4 "In fact, NRC acknowledges a number of l

S shortcomings in its regulatory program with respect to 6

chemical and other toxic hazards at fuel cycle facilities in 7

its own lessons learned report."

8 It also stated that, "It is the view of the 9

Committee that NRC must assume regulatory authority over 10 cherdical hazards when they cannot be separated from or could 11 potentially affect licensed radioactive material."

12 So it was just not the staff that was finding 13 fault with our regulatory program, there were outside i

i 14 entities that also were.

15 COMMISSIONER McGAFFIGAN:

Having come out of the 16 Congress, one of the great things Congress sometimes does is l

17 give you report language and no authority, and it can lead l

l 18 you astray.

This issue that Mr. Fertel brought up, he 19 believes that the rule that is proposed to us in the 20 chemical area goes beyond our regulatory authority.in that

-21 it doesn't just deal with those cases where it affects us, 22 but deals with things that are properly in the purview of

.23 EPA or OSHA, or their state counterparts.

How do you l

24 respond to that?

25 MS. EYCK:

Well, I am prepared to discuss that in ANN RILEY & ASSOCIATES, LTD.

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1 greater detail when we talk about the specific elements of 2

the rule.

But we have, basically, followed the OSHA MOU as 3

far as focusing on what our responsibilities are.

We have 4

. expanded to also address potential impact on the public, 5

besides just the worker, and that is a little bit of an 6

expansion, but we feel that, from our responsibilities from 7

protecting the worker and the environment around, that this 8

was appropriate.

But we can discuss that in a little bit 9

more detail-when we get there, if you would like.

10 At that time -- and NRC formed a task force to 11 also evaluate its regulatory program and their findings were 12 documented in NUREG-1324, proposed method for regulating 13 major fuel f acilities.

At that time the staff also 14 initiated a team assessment program to look for~ weaknesses 15 in the implemented programs at licensed facilities.

16 However, in November of 1992, the Commission

-17 directed the staff to upgrade the regulatory base for 18 assuring the adequacy of licensee performance rather than 19 trying to depend upon inspections to inspect safety into the 20 licensed facility programs.

21 After a reorganization in 1993 that combined fuel 22 cycle safety and safeguards programs, and Commission 23 approval of an action plan to improve the fuel cycle 24 regulatory program, staff started to rewrite -- or, 25 initially, to revise.the regulatory base, and then later, 4

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after Commission approval, to rewrite the regulatory base, 2'

because of the conditions of Part 70 and the weaknesses.

'3 COMMISSIONER McGAFFIGAN:

NUREG-1324 has been 4

referred to by NEI, and they quote senior Commission 5

officials at the time, as it is a " blue sky"' document.

What 6-would the ideal-be if it weren't constrained by anything?

l 7

But they said it is not a road map for going forward.

And I i

\\

8 don't'know whether. Commissions ever took a point of view on

)

9 1324 in a SRM or whatever, but the plain words in 1324, as 10 described by the author, seemed to imply that he or she did 11.

it without a lot of constraints.

12 MS.'EYCK:

It was a staff effort to review the 13 regulatory program, and they did include a lot of 14 recommendations on how to improve it.

Our proposed 15 rulemaking.does not endorse all of the proposals that were 16 in NUREG-24.

We are just showing that there was a staff 17

. effort at the time to identify where there were areas that l

.18 needed improvement.

Upgrading the regulatory base was one.

19 Having.some type of a hazards analysis to have a basis for 20 risk was another one.

So there were a number of-areas --

i 21 addressing chemical hazards was another one.

So what the

'22 staff basically did was look the evaluations of the programs j

23 by all the different entities and just came up with 24

-recommendations on ways to improve it.

But this rulemaking

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contained in that document.

It is only a recognition that 2

it was recognized by both NRC and outside entities that 3

improvements were necessary in the fuel cycle safety 4

program.

5 Basically,.we were asked by the Commission to 6

upgrade the regulatory base and we started that effort.

7 Industry was initially opposed to any changes in the 8

regulatory base, and staff then conducted a number of public 9

meetings to try to discuss our proposed approach with them 10 and to explain what we were looking for in both the rule and 11 the standard review plan.

l 12 In a Commission meeting in 1996, industry, while 13 not endorsing the staff's proposed approach in Part 70, did 14 support the conduct of an ISA, as they.had mentioned earlier 15 here.

The' Commission at that meeting also encouraged the 16 industry that.if they did not support the staff's proposed 17

. approach, that they would propose their own program.

And in 18 September 1996, as was mentioned earlier, the Nuclear Energy 19 Institute, on behalf of the fuel cycle industry, did submit 20 a petition for rulemaking.

21 In SECY 97-137, the staff proposed a resolution to 22 that petition.

Staff agreed in principle, since it did 23

. include the conduct of an ISA with the industry approach, f

24 but they did not agree in total and suggested some proposed l

25 modifications l

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In August of 1997, the Commission approved the 2

staff's proposed approach and directed the staff to proceed 3

with rulemaking, and you now have that rulemaking before 4

you.

5 Next viewgraph, please.

The current Part 70 has a 6

number of weaknesses, and among the more significant if the 7

fact that it is not based on a specific risk-informed 8

approach.

Protection against an inadvertent criticality is 9

not specifically required.

The primary --

10 COMMISSIONER McGAFFIGAN:

Could I stop you on that 11 point?

Because, again, you and NEI'just are on -- they say 12 that 70.22 (a) (8), and I have looked at it, specifically

~13 requires procedures to, quote, " avoid accidental 14 criticality."

I mean what -- so if we have a rule that-says 15 you are to, quote, " avoid accidental criticality," why isn't 16 that protection against inadvertent or accidental 17 criticality?

18 MS. EYCK:

Well, we' feel that the procedures to 19 avoid it is not as strong a basis as for them to evaluate 20 the risk from all of the areas of criticality and implement 21 procedures to protect against it.

And that is what we are 22 looking at, is a risk-informed approach that does protect,

'3 or does specifically-say that they must protect against 2

24-criticality.

25 Where it is included is in just a little -- in the ANN RILEY & ASSOCIATES, LTD.

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content of an application that just says that it should 2

address procedures, that criticality should be avoided.

We 3

feel that that is an insignificant reference to a safety 4

issue that is as important as nuclear criticality.

~

5 Okay.

An analysis to identify the hazards such --

6 of an ISA and the identification of items relied on for 7

safety is not required.

8 The current two part license format only requires 9

in Part 2, at the time of a license submittal or a renewal, 10 that the operator discuss their safety program.

There is no 11 commitment to notify NRC of any changes they would to that 12 program.

And over time, the safety basis, or the safety 13 discussion is not representative of the total of the 14 licensee's programs.

Just as was mentioned earlier, that 15 they -- when they go through license renewal, they have to 16 come back and totally rejustify, or discuss their safety 17 basis.

That is because that it has eroded over time and 18 there is no requirement for them to keep NRC up to date on 19 that.

That is why we are proposing that NRC would have that 20 type of a program where we would have a current safety 21 basis.

22 And we also found in the rule --

23 COMMISSIONER DIAZ:

Excuse me.

In Part 70 there 24 is also kind of a weakness in that when you get to time, you 25 know, timely renewal.

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MS. EYCK:

Timely renewal.

Yes, that is an issue.

2 We didn't raise that here, but that is an' issue.

And the 3

fact that there is no time restraints on the licensee on 4

when they -- except that they have to submit their renewal 5

before the license expires.

There is then no timeliness ca 6

when all that action has to be completed.

So we end up with-7 no sense of urgency on, when we ask them for additional 8

information, to answer questions that were not addressed in 9

their application,'for them to respond with anything.

So 10 that is a problem.

But I think we have got a solution to 11 that in the fact that if we do incorporate the ISA as a 12 safety basis, we have a living license.

And so when it 13 comes to license renewal, it is almost a pro forma activity, 14 because we.already have in-house their current safety basis.

15 So I think that we have come up with a solution to that, but 16 it is a problem with cur current program.

17 COMMISSIONER DIAZ:

But if there is a significant 18 safety issue, let's just assume, in the in between, what 19 process do we have to address it so it won't linger on?

20 MS. EYCK:

I was going to plan to address that in 21-more detail later on --

22 COMMISSIONER DIAZ:

No, no.

Okay.

23 MS. EYCK:

the specific elements.

If we could 24 wait until just then.

25 COMMISSIONER DIAZ:

Fine.

Sure.

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MS. EYCK:

Okay.

And also activities such as QA I

2 and maintenance are not required.

Now, the industry has

]

3 addressed the SRP and they say that it includes a number of 4

these programs.

It was never our intention to require all 5

of those programs to be applied across the board.

The SRP 6

basically says that in items that are relied on for safety, 7

you have to ensure measures to make sure that they are 8

available and reliable.

And if one of those measures 9

happens to be something like maintenance, then the reviewer 10 would go to the section that includes criteria for 11 maintenance and what would be an acceptable maintenance 12 program.

Is it a preventive maintenance program?

What 13 should they look for?

14 So there is no intent for all of the programs to 15 be in the ISA.

The ISA is a guidance document.

It doesn't 16 provide -- it doesn't issue requirements or anything.

All 17

.it does is when the licensee proposes such a program, this 18 is a section that allows them to go and look based on 19 existing guidance or, you know, basic -- what can I say, you 20 were talking about earlier, 21 DR. PAPERIELLO:

Consensus standards.

22 MS. EYCK:

Consensus standards to what would be 23 viewed as an acceptable program.

We can get in more in 24 this.

I didn't want to get off --

25 COMMISSIONER DIAZ:

I was going to say, if the ISA 8

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is a guidance document, what should be a part of the 2

license?

3 MS. EYCK:

The SRP is a guidance document.

I'm 4

sorry.

5 COMMISSIONER DIAZ:

Oh, I'm sorry.

6 MS. EYCK:

If I said ISA --

7 COMMISSIONER DIAZ:

You said ISA..Okay.

8 COMMISSIONER McGAFFIGAN:

Let me just take the one 9

example that they talked about in their testimony.

If you 10 are a license examiner and the QA program is required, the 11.

SRP says that ANSI -- this consensus standard, ANSI QA 12 standard is an acceptable way to meet the rule, they said 13 that they don't believe that that is necessarily going to be 14 required for even the high risk items identified in the ISA.

15 If a reviewer comes -- you know, is reviewing an 16 application and comes across this and they don't want to use 17 ANSI QA and they justify using a lower standard,'how much 18 are we going to grind on whether that different standard is 19 acceptable?

-20 MS. EYCK:

Well, the SRP is just one way of 21 meeting our requirements.

They can -- they are more than 4

22 welcome to justify other ways of doing it.

And the guidance 23 document doesn't say that they have to have a OA-1 program.

24 I think it says something like that they may refer to in 25 QA-1.

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What is.in the SRP would be for a high risk 2

criteria.

If it is a lower risk based on their ISA, then 3

lower requirements would be acceptable in meeting the OA.

4 You know, we are just looking at it.

We are trying to give 5

the reviewer some guidance.

We are trying to standardize, 6

as Carl has mentioned earlier, the licensing review process, 7

and this document is-just guidance as far as what way 8

--things that would be acceptable.

9 COMMISSIONER McGAFFIGAN:

But if I am reading it, 10 and from industry, I know from reading the document that if 11 I come up with this ANSI QA, it is going to be a no-brainer 12 for the staff, they will go on to the next page.

If I am 13 trying to justify something else, it is going to take some 14 time and I am going to have to provide some degree of detail 15 to justify it, and he or she is going to ask a bunch of 16 questions on it.

And so, de facto, I think what they are 17 worried about is if you.say this -- if it is the only way 18 mentioned for a high risk item, 19' MS. EYCK:

No.

20 COMMISSIONER McGAFFIGAN:

.It is not.

Okay.

21 MR. CALLAN:

Commissioner, you point is correct,

'22 that,the'SRP in both reactor space and Part 70 space does 23 provide, if you will, the path of least resistance for a 24.

licensee, and to deviate from it does usually involve more 25 resources and time.

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ensure that the SRP provides a de facto set of expectations 2

as well.

And so I think that needs to be said.

3 MS. EYCK:

And it is.

Okay.

In resolving these 4

NEI petition, the staff recommended that the Commission 5

endorse an approach that the proposed risk-informed 6

rulemaking be based on the performance of an ISA, which is a 7

type of a hazard analysis similar to that developed and used 8

by the chemical industry.

9 The conduct of an ISA and the identification in 10 the license application of items relied on for safety and 11 measures to ensure their continuous availability and 12 reliability is deemed by the staff to be the foundation of 13 the proposed risk-informed approach.

14 Licensees will be provided to make changes based 15 on the results of the ISA on their safety program without 16 NRC prior approval.

The process would be that they could 17 make those changes if they have already addressed it in the 18 ISA and it doesn't introduce any additional problems, and 19 then periodically, maybe every six months or every -- send 20 NRC a change page to their summary submittal of the ISA so 21 that NRC would have a current copy of their summary of their 22 ISA.

23 It is only changes that would be new processes or 1

24 major changes that would require an amendment to come and 25 actually change the license.

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COMMISSIONER McGAFFIGAN:

I am sorry to keep 1

2 asking, but that, the 50.59 criterion you have in the rule, 3

I am not sure it is only major changes.

It is more than 4

minimum changes, right?

It is changes, and there's a big --

l 5

you know, in my dictionary there is a big gap between 6

minimum and major or significant, and if it is only the 7

significant -- they are saying, one of the people who 8

talked, that at his plant there's 800 changes a year, and 9

zero to 2 or so come before you at the moment under the 10 license conditions that that plant operates under.

And the 11 fear is that that under this new rule, with the 50.59 12 provision, and the word minimal in it, that a far larger 13 percentage of those 800 will come to us, which will consume 14 his resources, and consume resources that perhaps you don't 15 have to then provide approval for the changes.

So how do 16 you respond to that?

17 MS. EYCK:

Well, first off, only the changes that 18 we will be interested in are ones that introduce new high or 19 intermediate risks.

The graded approaches, we will be j

20 focusing only on the higher risk items.

They can make all l

21 kinds of changes to their process if, through their ISA, it 1

22 doesn't introduce any of these types of risks, which I will 23 describe in a little bit more detail in a minute.

So it 24 isn't all these 800 changes.

25 First off, if the change doesn't -- is covered by ANN RILEY & ASSOCIATES, LTD.

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the ISA, then they don't have to submit to us.

You know, 2

they can make that change and then just submit us a summary 3

change page.

If it does introduce some change that they 4

have to change their ISA, that is when they would have to 5

come forth and we would review the change and the impact on 6

their licensing program.

7 CHAIRMAN GLEIMAN:

Mr. Milstein, do you want say 8

something?

9 MR. MILSTEIN:

No, I was just nodding in 10 agreement.

11 CHAIRMAN JACKSON:

Okay.

12 COMMISSIONER McGAFFIGAN:

What number do you 13 expect to receive of changes that would be determined to be 14 above this, you know, the equivalent of an unreviewed safety 15 question threshold and, therefore, would require a change in 16 the ISA which is now, you know, the rule in the basis of the 17 plant and then how long do you -- how many resources do you 18 require to process all of those license amendments?

19 MS. EYCK:

First off, I don't think I am the 20 person to ask what changes they would make in their process 21 that would increase the risk.

I think that the industry 22 would be in a much better position to characterize the 23 various types of changes they make and how these 800 24 changes, how significant they are.

25 But I would say that we don't have a whole lot of ANN RILEY & ASSOCIATES, LTD.

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resources in the fuel cycle program, as you understand.

So 2

I would expect the very n.inimal types of changes would come 3

to us to have that type of review.

But there are some 4

changes like when they significantly change their process 5

from a wet to a dry, that we would expect to see an 6

amendment.

7 There's processes where they are doing new type of 8

work, which the licensees are doing now.

And we would 9

expect if it a new type of a process that isn't covered by 10 their ISA, that they would come to us for a review.

11 COMMISSIONER McGAFFIGAN:

It strikes me that you 12 may be in violent agreement on what the goal is, in terms of 13 the number of items that you want to be reviewing, and that 14 may already be captured by the license conditions that are 15 in the existing licenses.

But there is real fear that the 16 words will -- that are in the rule at the current time may 17 not get the result that you just described.

18 CHAIRMAN JACKSON:

Mr. Milstein.

19 MR. MILSTEIN:

Again, later on you will see the 20 categorization of risk that we are talking about.

But many 21 of these risks, many of these changes I think will fall 22 below tha~ threshold.

And they won't even come to the 23 threshold of actually having to be considered as affecting 24 the ISA.

So I don't I really don't know the answer to 25 the question, but I suspect that it may not be -- many of l

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them may fall below that threshold and won't even have to be" i

2 considered at all.

l 3

CHAIRMAN JACKSON:

Go ahead.

4 MS. EYCK:

Also, a graded risk-informed approach 5

for reporting of events will also be established and 6

requiring particularly the reporting of loss or degradation 7

of items relied on for safety.

A qualitative backfit 8

mechanise to enhance regulatory stability would also be 9

considered by the Commission after licensees have conducted 10 and implemented an ISA and have provided NRC with the i

11 details of that safety basis to use as a baseline for I

12 determining incremental risk in a backfit analysis.

13 In the case of Part 76 that was mentioned and the 14 industry, and the millions of dollars that have had to be 15 spent on modifying systems, the initial premise was that the 16 DOE orders and rules were comparable to the NRC 17 requirements.

And when the backfit provision was 18 implemented, it was with the understanding that we would 19 receive an acceptable safety basis because they had been 20 operating for this long period of time.

But, in reality, 21 what happened, we got a safety basis that had a lot of 22 weaknesses.

And the corrections that were made in the 23 systems that were upgraded were to come up to DOE 24 requirements, not that they were required for NRC 25 recairements.

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It's also important to note that in the areas 2

where they didn't have an appropriate safety basis, we had a 3'

compliance plan, and they were required to do certain things

~

4 in that compliance plan to bring their safety basis up to an 5

acceptable level.

Those are the things that they did that 6

were not under backfit.

Because backfit assumed an adequate 7

safety basis, and they did not have it at the GDPs.

And 8

that was why changes were' required, not because the staff 9

was not implementing the backfit provisions.

10 Next slide, please.

This viewgraph contains a 11 list of items that are really the major elements that we 12 have included in Part 70 that I would like to discuss in

'13 greater detail now.

14 Next slide, please.

An important element in the 15 proposed rulemaking package was the identification of 16 specific consequences against which licensees must provide 17 adequate protection.

The consequence criteria are not new, 18 but are based on existing radiological and chemical 19 standards developed previously by NRC, other government 20 agencies and professional societies.

21 The consequences which are applicable to both 22 workers and members of the public are categories according 23 to their level and severity of consequences in two

.24 categories, high and intermediate.

Because accidents at 25 fuel facilities could result in human exposure to both ANN RILEY & ASSOCIATES, LTD.

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radiological and chemical hazards, the proposed rule adogted' 2

criteria that address both types of consequences.

It also 3

codifies the MOU that we established with OSHA to address 4

chemical hazards affecting workers.

5 Next slide, please.

6 COMMISSIONER McGAFFIGAN:

As you saw, the NEI 7

slide said that this conflicted with the OSHA MOU.

I tried 8

to ask whether you were trying to implement the OSHA MOU.

I 9

guess your answer is you are trying to implement the OSHA 10 MOU.

But the --

11 MS. EYCK:

If you will turn to the next slide.

12 COMMISSIONER McGAFFIGAN:

Okay.

13 MS. EYCK:

If you have the next slide, we can see 14 what our consequences and how they implement the OSHA.

The 15 OSHA one is primarily focused on worker protection.

And we 16 adopted the standards that deal with the consequence of both 17 workers and members of the public.

On the viewgraph, the 18 consequences that are identified as high include accidental 19 exposure to the worker or a member of the public to high 20 levels of radiation and hazardous chemicals.

It also 21 includes, as you will see, the occurrence of a nuclear 22 criticality.

23 The consequences identified as intermediate l

24 include accidental exposure of the worker and the members of i

25 the public to moderate levels of radiation or chemical

~

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hazards.

It also includes environmental contamination.

2 Now, this is one area that -- in our original proposal to 3

you, we didn't include environmental contamination.

But as 4-we looked at all of the rules, the requirements that we have 5

to meet for the Part 70 license, the NEPA requirements 6

regarding exposure on contamination were one of the things 7

that we thought was important so we included that and we 8

felt that it would fit in in the intermediate, as an 9

intermediate hazard.

10 COMMISSIONER McGAFFIGAN:

Could I ask, maybe this 11 really goes to.the General Counsel, who presumably signed 12 off on this paper..Is there a problem here with us trying 13 to enforce other agencies' authorities through our 14 rulemaking?

I know the Congress has recently criticized us 15 the in the case of uranium mill facilities for trying to 16 enforce, at least one committee of. Congress, trying to 17 enforce the in-ground aspects, that the state or EPA are 18 supposed to enforce, in our licensing and rulemaking 19 process.

20 MS. CYR:

Well, I think with respect to the 21 chemical hazards, and I think you have -- in the MOU, there 22 are sort of like four categories of hazards that are 23 described there, and it says three of them are clearly ones 24 that are within our scope of what we view as within the --

25 they are, in a sense, a mixed -- the chemical hazard is, in ANN RILEY & ASSOCIATES, LTD.

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a sense, either inextricably linked with the use of the 2

material or it is associated with assurance of safe 3

utilization and use of the material.

4 For instance, like on the plant conditions, if you 5

had a chemical hazard that would somehow impact your ability 6

to get in and deal with the radiological safety of the 7

plant, that then you could look at the chemical hazard in 8

that context.

But strictly chemical hazards that did not, 9

in a sense, have those attributes were not ones that we 10 would be looking at.

11

.And so I think if you read the staff's framework 12 in that context, I think using chemical hazards within those 13 categories of kinds of activities, that's okay.

14 Again, under NEPA we have obligations, in a sense, 15 to look for the -- look at the impacts of the various 16 activities that we license and try to minimize those impacts 17 in terms of taking into account those impacts in the context 18 we license and look at those hazards.

19 So, I think, again, there is a basis there to look

.20 at and to try to achieve, in a sense, the most 21 environmentally benign process we can in the context of L

22 looking at the license and trying to look at alternative 23 ways of dealing with things in the context of licensing.

l 24 So, again, I think there, again, in terms of how it is tied 25 to the processes that were licenses, we have a basis to get ANN RILEY & ASSOCIATES, LTD.

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in and look at those activities.

2 But if you are looking at, again, just a 3

free-standing requirement that is not-driven by a process or 4

a licensing activity that we are looking at, that that might 5

be problematic.

But I think --

6 COMMISSIONER McGAFFIGAN:

It strikes me that it 7

sounds like there is a gray area there and the counsels need 8

to talk to each other.

9 CHAIRMAN JACKSON:

Well, the question is whether 10 there could be more clarity of language.

11 MS. EYCK:

And within each category, the 12 radiological and chemical criteria for a given level of 13 severity do not necessarily represent equivalent levels of 14 health effects.

However, they do represent current 15 regulatory practice.

16 Next slide, please.

To achieve an acceptable 17 level and to minimize the regulatory burden, the proposed 18 rule revision' requires licensees to provide a graded level 19 of protection to sufficiently reduce the likelihood of 20 accidents commensurate with their consequences.

Thus, the 21.

occurrence of a high consequence event should be highly 22 unlikely, and the occurrenceuof an intermediate consequence 23 event should be unlikely.

The terms are defined in the SRP 24 with criteria for judging the likelihood of potential 25 accidents.

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Next slide, please.

The proposed rule requires 2

. licensees or applicants to perform an ISA.

We have defined 3

an ISA as a systematic analysis to identify plant and 4

external hazards and their potential for initiating accident 5

sequences, to identify the potential accident sequences and 6

their likelihood and consequences.

And, finally, to identify the items that are relied on for safety to protect 7

8 against the hazards.that are identified.

a Licensees must demonstrate, based on the 10 performance of an ISA, their ability to provide an adequate 11 level of protection against accidents that could occur at 12 their facilities.

13 Next slide, please.

We agree with NEI'that the 14 performance of an ISA to identify items relied on for safety 15 and.the implementation of measures to ensure the continuous 16 availability and reliability of these measures are important 17 items towards increasing the confidence in the margin of 18 safety at these facilities.

H19 However, without incorporating the summary of the i

20 ISA in the license, and'the identification of. items relied 21 on for safety, and commitments regarding how they will 22 maintain these items available and reliable, NRC would not 23 have a safety basis for regulatory decisions that would be t

1 r

24 available'for public scrutiny, 1

I 25 CHAIRMAN JACKSON:

So let me make sure I heard.

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Did you say you were requiring the summary of the ISA?

2 MS. EYCK:

Just a summary of the ISA, not the ISA.

3 Only a summary.

And this has been contention between us and 4

industry -- I shouldn't say contention -- an item of 5

disagreement on what is the appropriate -- what is 6

appropriate to include in the summary.

And we have been

  • 1 7

kind of talking back and forth from each other.

So I have 8

asked the staff, and it is a part of this package, to put 9

together what we would consider a summary submittal, and 10 what it would include.

11 Now, obviously, this is a guidance -- in the 12 guidance area, and it is something that we have a strawman 13 now to talk specifically about whether what industry feels 14 is an over-requirement versus something that, you know, we I

15 feel is important to have.

So we have something concrete to 16 talk about.

You know, I agree that it may not be perfect.

)

17 But we are working towards trying to get a consensus of what 18 would be appropriate to include in a summary.

19 Now, the industry has indicated today that what we 20 have included was above their expectations on what they had 21 to provide.

So I think we have got, you know, some area to 22 work in there.

But we do think that it is important to just 23 have a summary.

And here, again, this is only what they 24 would be updating, is our summary.

It wouldn't be the 25 entire ISA.

They could make changes to their ISA, whatever, ANN RILEY & ASSOCIATES, LTD.

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as long as it didn't affect the summary of the accidents and'

'2 consequences and measures and items relied on for safety.

3 CHAIRMAN JACKSON:

So you are saying you have 4

started down a path to try to resolve this?

5 MS. EYCK:

Well, I have started with the point 6

that we have a draft document that it gives our perspective.

7 We feel that it is a very good document, that when the rule 8

goes out for public comment, people will have something 9

there to review and to give us feedback on whether they 10 think that what we are asking for is appropriate or 11 inappropriate.

12 CHAIRMAN JACKSON:

So you have included it in this 13 package?

14 MS. EYCK:

It is in the rulemaking package, yes, 15 COMMISSIONER DIAZ:

It might not be an easy answer 16 for this, but can we have whatever is needed from the ISA L

17 that is in here, call it quote-unquote, docketed, but not 18 part of the license?

19 MS_ EYCK:

I think maybe that might be a better l,

20 question for OGC.

l 21 MS. CYR:

I don't think you have to have that as I

i 22-part.of your license in order to be develop enforceable 23 license conditions.

I think there are other ways that you it is a matter of approach -- at what seems 24 could get at

-25 to be most straightforward or usable between the staff and ANN RILEY & ASSOCIATES, LTD.

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the licensee, in terms of how you want to go about having a**

2 basis to make sure that those elements of the activities at 3

the site, that you have a way to make sure that they 4

maintain those.

I mean and that is -- you may be able to do l

l 5

that through a license condition or it may be without L

.6 necessarily having it as a piece --

7 COMMISSIONER DIAZ:

As part of the license.

8 MS. CYR:

As part of the license.

l l

9 MS. EYCK:

We have the answers to come in to our 1

10 response to questions.

They are documented, they are not 11 necessarily a part of the license, but they might be 12-included in the safety analysis report that is written for 13 the licensing activity.

14 COMMISSIONER DIAZ:

Because there is an issue here 15 whether it is part of the license or not, and there is 16 another issue is having the information that is required 17 available.

And it might be that we can have whatever 18 information is available and not having it part of the 19 license.

20 CHAIRMAN JACKSON:

What is -- I guess I am trying 21 to understand what the significance is, if you are talking 22 in terms of a summary, of having it as part of the license 23 versus having it docketed.

What is the difference?

24 MS. EYCK:

We think, from our perspective, I think i

25 one of the reasons is we"think that have it a part of the

]

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89-1 license is a formal commitment to, particularly, on the 2

identification of items relied on for safety.

We have had 3

situations where we have had events and we have gone to the L-4-

facility and we have said, okay, what are the items that are 5

you are relying on for safety?

And they weren't initially 6

able to. provide us with the details of what are those items j

7 that are relied on for safety.

8 And then there's other situations where we are L

9 trying to develop a risk-informed inspection program.

And 10 if we knew and had a commitment to what were the items 11 relied on for safety, then we can focus our inspections on 12 those high risk areas to make sure that the measures are 13-being maintained and the controls are available and

-14 reliable.

So there's just more of a formal identification

'15 and commitment when it is contained in the license.

16 COMMISSIONER McGAFFIGAN:

It just strikes me that 17 what you just said could be achieved through the alternative 18 of having a commitment to having a living ISA but without 19 having it in the license.

You will then -- they will have.

20 If they don't have it, like they said, you enforce them for 21 not having it.

And if'they --

l 22 CHAIRMAN JACKSON:

I think, though, there is a i

23 question of what-the NRC needs to have in its hands.

24 MS. EYCK:

Yeah, it is a question also -- I'm I,

25 sorry -- of the documentation of what is the basis of our ANN RILEY & ASSOCIATES, LTD.

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90 1

determination of the license -- in the license that we say 2

that they are safe to operate.

And that, by incorporating 3

it in the license is their documented safety basis.

4 CHAIRMAN JACKSON:

What about -- is there a way to l

i 5

do it as a docketed'-- see, I guess that is a legal issue 6

for me.

7 MS. CYR:

I mean again, NMSS staff has 8

traditionally written licenses where they incorporate by 9

reference large segments of the applications as part of the 10 license conditions or the license impositions.

11 NRR doesn't do it that way.

I mean they write up 12 SERs, which in a' sense is their safety basis for the 13 decision.

And then you have a license which consists of 14 technical specifications and a set of very specific license 15 conditions, which take these, for instance, these items that 16 you are relying on for safety and you impose those as tech 17 specs or something that you have to maintain with respect to 18 the license.

I mean it has been a difference of an 19 approach.

So it is certainly possible to document the basis 20 for.your decision and sort of what you have relied and what 21

-- to determining that there is an adequate protection of 22 safety here, without necessarily incorporating all that 23 information into the license itself.

24 CHAIRMAN JACKSON:

You were going to say j

25 something?

I i

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COMMISSIONER DIAZ:

And I will bring Part 65 back.'

2' I mean we had a lot of requirements under Part 65, and they 3

do all of this configuration management and process 4

controls, you know, and all of these things.

But they are i

5 actually, you know', not part of, quote, of the licensing 6

document.

They do all of the activities, but they remain i

7 part of the licensing activities.

8 We have the right of inspecting them, but they 9

remain.

10 CHAIRMAN JACKSON:

Can you, if you go to your 11 slide.11, can you -- this is the one you are on, I think.

12 MS. EYCK:

Right.

13 CHAIRMAN JACKSON:

Can you have all of these 14 requirements in the rule?

Have the information that you 15 need documented and docketed in some other way, but still be 16 able to get at these three elements without having them in?

17 MR. CALLAN:

Chairman, I think that the -- whether 18 or not we have the information available is separate from 19 the question of whether it is in the license.

20 CRAIRMAN JACKSON:

What form it is in.

21 MR. CALLAN:

Yes.

22 CRAIRMAN JACKSON:

That's right.

23 MR. CALLAN:

We can definitely have it docketed 24 without having it in the license.

25 CHAIRMAN JACKSON:

Right.

Okay.

Go ahead, Carl.

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92 1

1 DR. PAPERIELLO:

I don't think we are all that faf l

2 from the industry on this issue.

I mean I think this is one j

3 of these things that, within a relatively short time, we can 4

work out something.

l 5

CHAIRMAN JACKSON:

Well, it sounds to me like what 6

may have happened goes back to what we talked about earlier l

7 in terms of to what extent you felt you were free to share 8

everything. -But you need to kind of get this one worked out i

9 and so it strikes me that, you know, there is a success path 10 that ought to be possible, but it ought -- you know, without 11 losing these essential elements.

l 12 MR. CALLAN:

Chairman, there is one point I think l

l 13 Ma.rv made regarding this issue that I'll try to paraphrase.

14 And that is if the ISA is in the license, then it is j

15 difficult to keep it a living document, because every change l

lo' becomes --

l 17 CHAIRMAN JACKSON:

Becomes a license amendment.

18 MR. CALLAN:

Becomes a license amendment.

It is a j

19 much more ponderous process.

20 CHAIRMAN JACKSON:

Right.

1 21 MR. CALLAN:

And I think that is --

l 22 CHAIRMAN JACKSON:

Well, that's why I asked the l

i 23 question.

I mean it seems to me that, you know, another big

^

24 piece would have to do with changes and how easily one could l-25 make those changes.

~

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MR. CALLAN:

Right.

~

2 CHAIRMAN JACKSON:

But I think --

3 COMMISSIONER McGAFFIGAN:

Next viewgraph.

4 CHAIRMAN JACKSON:

Right.

All right.

Well, no, 5

and the issue is if you treat it -- shudder, shudder, like 6

an FSAR --

7

{ Laughter.}

8 COMMISSIONER McGAFFIGAN:

That's what they are 9

worried about.

10 CHAIRMAN JACKSON:

Well, no, because the FSARs are 11 not -- so, go ahead.

12 COMMISSIONER McGAFFIGAN:

A lazier way of dealing 13 with it.

14 CHAIRMAN JACKSON:

Right.

15 MS. EYCK:

Okay.

The ISA by itself will not 16 ensure adequate safety.

An effective management system is 17 also needed to ensure that when the items are called on to 18 perform, that they indeed will be able to accomplish their 19 particular role.

And this is the issue, one of the issues 20 that the industry had concerns on.

We listed some items 21 that would be considered as potential candidates for a 22 management system and activities like maintenance must be 23 provided to ensure that when hardware is used as an 24 engineering control, or an engineered control, that it is 25 available and reliable to perform its function.

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[

94 1-Training should be established to ensure that an 2

individual, when they are asked to perform a function as an 3

administrative control, and this happens quite often at our 4

fuel facilities, are appropriately trained and understand 5

the function that they are supposed to -- the safety 6

function that they are supposed to perform.

So that is why 7

we have included these items in the ISA -- I mean in the 8

SRP, it is to give guidance to the licensee -- to the 9

reviewer and the licensee on things that could be included, 10 whether it is a human factors issue that maybe an individual 11 could take an action that could complicate a accident or 12 make it worse from a risk perspective.

There could be 13 maintenance configuration management control, there's a long 14 list of them.

But they are certainly requirements that we 15 are putting on all of their programs.

16 It is only on these controls and they will be 17 graded based on the fact, whether they are providing 2

18 protection against a right risk accident or an intermediate 19 accident.

So that is how -- that was our proposal and how 20 we propose to use the information that is in the standard 21 review plan.

22 COMMISSIONER McGAFFIGAN:

The other thing that 23' comes to mind from the previous discussion, the systematic 24 approach to training requirement that's in the SRP for 25 high-risk, again, you heard industry differ with that, but t

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that is the de facto approach that's in the SRP at the 2

moment.

3 I'm partly afraid, in all honesty, as I see this, 4

that you all are taking stuff from reactor space where we 5

have, you know, systematic approaches to training and all 6

that, and these facilities may not need just as much because i

l 7

the risks are so much lower than for the reactors.

8 But there's an awful lot of verbiage that is l

9 familiar as you look at this, and it's coming over from 1

10 reactor space into material space, and we need to think 11 about whether we need it all in the SRP, I think.

12 MS. EYCK:

Okay.

Well, we, as I say, just 13 provided it there to -- basically what's there is to address l

14 the high-risk items with the thought that it would be graded l

15 for lesser risk, and to -- if there was a single human 16 administrative control that's going to protect against some 17 high-risk item, we wanted to make sure that we had guidance 18 on what would be an acceptable training for that individual l

19 to ensure that they properly. performed their safety 20 function.

21 CHAIRMAN JACKSON:

It seems that the nub is in 22 what the gradation is.

I mean, that's how you really 23 address the issue as to whether the requirements are as 24 onerous as they might be in a reactor situation or not, and 25 if they're not, but it's graded appropriately, then that in ANN RILEY & ASSOCIATES, LTD.

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principle should address the issue.

2 MS. EYCK:

Okay.

Next slide, and this deals with 3

the issue of changes that can be made without NRC prior 4

approval --

5 CHAIRMAN JACKSON:

Has minimal been defined?

6

[ Laughter.j 7

MS. EYCK:

Well, we know that it's greater than 8

negligible but less than significant.

9 COMMISSIONER DIAZ:

There you go.

There you go.

10 You've been doing your homework.

11 CHAIRMAN JACKSON:

Or at least you're turning into 12 a politician.

13

[ Laughter.)

14-MS. EYCK:

And also, we feel that it's important 15 that the change not create a possibility for an accident 16 different than those previously evaluated in the ISA, and 17 that is another important criteria for us.

18 Okay.

Next slide.

19 The proposed rule also includes a risk-informed 20 graded approach for licensee reporting of events.

Now, 21 reporting deviations from the safe operating conditions 22 involving nuclear criticality was covered by bulletin 91-01, 23 and that has been incorporated in the rule.

24 But the proposed rule also requires the reporting 25 when all items relied on for safety are no longer ANN RILEY & ASSOCIATES, LTD.

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97 1

operational or are degraded so that they cannot perform 2

their intended function.

And the time frame for reporting 3

of such events are based on consideration of consequences of 4

concern.

So it's a graded reporting of events and also the 5

timeliness for reporting of such events.

6 Next slide, please.

7 The proposed rule also contains two provisions 8

specifically addressing new facilities and new processes.

9 This was also discussed earlier.

And based on staff 10 experience providing support to DOE in their development of I

11 a remediation system to process the waste from the Hanford 12 tanks, the staff has realized that it's very important to 13 have new baseline design criteria to be considered initially 14 at the beginning of the design, and it's also for new 15 facilities or for a totally new process at an existing 16 facility.

17 These baseline design criteria ensure that certain 18 design principles are fol. lowed in the initial' design, and 19 applicants or licensees would use these criteria, and --

20 unless the preliminary ISA submitted to NRC prior to 21 construction demonstrates that a given item is not needed or 22 to be relied on for safety.

23 Now, we get into the preliminary ISA, and 24 basically what this is is that it's no different than what's l

25 done in the chemical industry.

They use their hazards i

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analysis through the entire process, through design and

.2 implementation.

We felt that it's prudent management 3

practice for the design of a -- for a new design for them to 4

think through the risks that would be associated with that l

5 activity rather than getting to the point where they're 6

ready to construct or they come in or a license and then 7

it's a question of having to go back and incorporate the 8

considerations of risks and the hazards from nuclear 9

criticality and chemical and fire into their design.

1 l

10 That's why we felt that it was appropriate to have 11 an initial preliminary ISA done, and then-as they go through 12 and finish'their design, build their facilities and 13 everything, then they will be finalized --

14 CHAIRMAN JACKSON: -Would licensees be able to 15' begin construction of a new facility at their risk before 16 the --

17 MS. EYCK:

Oh, sure.

We're not --

18 CHAIRMAN JACKSON:

-- preliminary ISA --

19 MS. EYCK:

All we're saying is that if they gave 20 us their preliminary ISA, we could re-review it and we can 21 see that if we feel that they've addressed all the potential 22.

risks, based on our experience --

23 CHAIRMAN JACKSON:

But they can begin the 24 construction, and if later --

25 MS. EYCK:

No problem.

We don't approve it.

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We' re just going to review it.

2 CHAIRMAN JACKSON:

Okay.

3 MS. EYCK:

Okay.

Next slide, please.

6 4

Okay. Well, basically in summary, the staff feels 5

that our draft proposed rulemaking is responsive to 6

Commission direction.

We have added a couple things that we 7

feel are important as we have developed the rule based on 8

our experience from other activities.

It is risk-informed 9

and its implementation will provide increased confidence in 10 the margin of safety at operating facilities.

11 Since 1995, as was mentioned earlier, staff has 12 been working closely with industry during the development of l

13 this rulemaking process, and although staff and industry 14 have not agreed on every facet of the proposed rulemaking, 15 we feel that our views have been converging, and I think l

16 that it's important to make the distinction here between the l

17 rule and the standard review plan.

I don't think that we 18 have heard any specific differences with what's included in l

19 the specific rule; it's questions with the SRP and the 20 guidance to the reviewer.

21 But basically, as Carl mentioned, we hadn't been l

l 22 able to share our documents with him because of the fact 23 that we were operating under a little different rulemaking 24 process than was used in Part 35.

i 25 In closing, I would just like to remind the

\\

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Commission that we have been working on this rulemaking 2

process for k long time, and that we would encourage the 3

Commission to support our publishing the proposed rulemaking J

4 package for public comment.

5 Thank you.

6 CHAIRMAN JACKSON:

Thank you.

7 Commissioner Diaz?

8 COMMISSIONER DIAZ:

Yes.

Just one comment or one 9

question that we. asked before.

In the issue of a license 10 renewal for this-facility's licensed continuation, how will 11 an ISA that is docketed play into solving the issues that 12 you presently have?

13 MS. EYCK:

I-think that if we have a docketed ISA 14 that represents the program --

15 COMMISSIONER DIAZ:

Docketed doesn't mean the 16 license, now.

17 MS. EYCK:

Right.

Oh, I understand that.

But at 18 least NRC has something that represents the safety basis 19 that represents the current operation.

What we're in a 20 situation now is that we get at the time of licensing a l

21 discussion of the safety program.

The licensees are free to 22 make changes to that program, and so what happens when it 23 comes to the time of renewal, just as it was mentioned, we 24 almost have -- we have to reconstruct the safety basis 25 because it has changed so much over time.

ANN RILEY & ASSOCIATES, LTD.

Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.

20036 (202) 842-0034 l

I 201 1

So I think that if we did have the process whery 2

they did keep it up to date and it was docketed or whatever 3

mechanism that's worked out so that we did have something to 4

have a current basis, that the licensing renewal would be a 5

pro forma activity because we wouldn't have to spend the 3

6 enormous amount of time, both our time and the industry's 7

time now, on trying to reconstruct this safety basis.

8 COMMISSIONER DIAZ:

Okay.

Thank you.

9 CHAIRMAN JACKSON:

Commissioner?

j 10 COMMISSIONER McGAFFIGAN:

I think you may be a 11 little more optimistic than warranted about the lack of 12 difference on rule language.

You know, a lot of the things 13 that they are raising issues about, the chemical 14 concentration level, et cetera, are in rule language, the 15 requirement that the license -- that the ISA be in the 16 license et cetera.

So I think there are very significant 17 differences still remaining between you and the industry on 18 rule language as well as obviously the SRP.

19 CHAIRMAN JACKSON:

Well, I want to thank each 20 presenter for providing us with very useful information in 21 terms of the Commission's decisionmaking.

I want to remind 22 everybody that what's being proposed is for the rule to go 23 out for public comment, which means it's not final, and so 24 the Commission has to make a decision about that, presumably 25 together with having the SRP also be available and have ANN RILEY & ASSOCIATES, LTD.

Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 l

Washington, D.C.

20036 (202) 842-0034

102 1

there be some continued work on it.

~

2 So unless there is any further comment, we're 3

adjourned.

(

4 (Whereupon, at 12:14 p.m.,

the public meeting was l

l l

5 concluded.]

6 7

8 9

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ANN RILEY & ASSOCIATES, LTD.

Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.

20036 (202) 842-0034

CERTIFICATE

~*

This is.to certify that the attached description of a meeting of the U.S. Nuclear Regulatory Commission entitled:

-TITLE OF MEETING:

BRIEFING ON 10 CFR PART 70 PROPOSED RULEMAKING, " REVISED REQUIREMENTS FOR LICENSING OF SPECIAL NUCLEAR MATERIAL" --

PUBLIC MEETING i

' PLACE OF MEETING:

Rockville, Maryland

DATE OF MEETING:

Tuesday, August 25, 1998 Ewas held as herein appears, is a true and accurate record of the meeting, and that this is the. original transcript thereof taken stenographically by me, thereafter reduced to typewriting by me or under the direction of the court reporting company i

Transcriber:_ Martha Brazil j.

Reporter:

Jon Hundlev CA4 v

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