ML23065A216

Sept 9th Transcript from the 1999 Agreement State Meeting (Sept 8, Sept 9, Sept 10)

ML23065A216
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Issue date:	09/09/1999
From:	Office of Nuclear Material Safety and Safeguards
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Huda Akhavannik, NMSS/MSST
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261 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3

4 ***

5 6 1999 ORGANIZATION OF AGREEMENT 7 STATES MEETING 8

9 Thursday, September 9, 1999 10 Renaissance Hotel 11 Trinity Rooms 12 Austin, Texas 13 14 Thursday, September 9, 1999 15 16 17 The meeting convened, pursuant to notice, at 8:00 a.m.

18 19 PANEL MEMBERS PRESENT:

20 FRANCIS X. CAMERON, Facilitator 21 DONALD COOL 22 KATHY ALLEN 23 SETH COPLAN 24 DAVID WALTER 25

262 1 PANEL MEMBERS PRESENT: [Continued]

2 CATHY HANEY 3 FRITZ STURTZ 4 PETE MYERS 5 CINDY CARDWELL 6 MEL FRY 7 RAY PARIS 8 AUBREY GODWIN 9 ROLAND FLETCHER 10 TERRY FRAZEE 11 JAKE JACOBI 12 RUTH MCBURNEY 13 DAVID SNELLINGS 14 STAN MARSHALL 15 16 17 18 19 20 21 22 23 24 25

263 1 P R O C E E D I N G S 2 [8:00 a.m.]

3 MR. CAMERON: Good morning. If you could please take 4 your seats, we're going to get started.

5 We really have a full agenda, particularly this morning, 6 where we're going to start out with state techniques for a 7 streamlined license renewal, and what's going to happen is Don Cool 8 is going to sort of talk about -- well, sort of, I guess -- he's 9 going to talk about the NRC process. And then we're going to go to 10 Kathy Allen from the Gold Star State of Illinois to set up the 11 discussion for us. And everybody is going to -- I know there's 12 going to be a lot of people who want to contribute to the 13 discussion. And if you look at your agenda, we're supposed to be at 14 Part 35 at 9:15, and we have to do the streamlining discussion and 15 also the performance-based regulation.

16 So in fairness to people this afternoon, I'd like to try 17 to keep us on schedule. So I may have to arbitrarily cut the 18 discussion off, and anything that we have left over we'll put up 19 here and we'll see if we can circle back and get that.

20 And what I'll do is turn it over to Don.

21 MR. COOL: Thank you, Chip. Good morning. Okay. How 22 many people have had a cup of coffee already and are actually awake?

23 Five? Okay. That means I'm probably pretty safe talking up here 24 this morning.

25

264 1 Once upon a time in a land not so far, far away, we 2 started to look at the fact that we were going to be faced with 3 renewals once again. What I want to talk to you about briefly today 4 is the renewal of materials licenses, and many of you, through these 5 meetings and the CRCPD meetings and other interesting and 6 diversified forums have heard us talk now seemingly forever -- it's 7 actually only been about four years -- about business process 8 reengineering and various sorts of things and the whole effort that 9 we had undertaken, back about the time I became division director in 10 '95, to try and recraft ourselves: make ourselves more efficient, 11 make ourselves more effective, try and figure out if there wasn't a 12 better way to go about trying to do this process.

13 A lot of you were involved in those activities. A lot 14 of discussions back and forth. Several things, if you'll recall, 15 came out of that. One was an extension of the renewal dates by the 16 NRC. There were a variety of reasons. The biggest one, quite 17 frankly, was I was looking for resources. And we looked around for 18 resources and we discovered that I actually had more resources in 19 the budget to do renewals than I had in the budget to do news, and 20 that the case load on renewals was much higher than all of those 21 others. So I said, Here's a target.

22 We crafted up some criteria. I think maybe it was the 23 first time in the Agency we'd actually drafted up some 24 performance-based criteria upon which to do an action, and we 25 basically extended 90-plus percent of all the renewals for five

265 1 years more or less automatically, without any incoming action or 2 otherwise, moved the dates out for five years which gave us a little 3 bit of a lull and an opportunity to go through and work on a variety 4 of things.

5 Well, we've been working on those things. We've been 6 working through a series of activities. Many of you have had an 7 opportunity to be involved in the guidance consolidation in various 8 activities. And now we are coming back up to the point in time when 9 suddenly there on the horizon is looming this mountain. And as we 10 got a little bit closer to it, we discovered that the mountain was 11 called renewals. They were coming back. They were going to be here 12 once again.

13 And the senior executives of the Agency up in the EDO's 14 office in what they call the executive council asked what probably 15 was a very logical question, Gee, what are you going to do about all 16 the resources you suddenly have in that budget to do renewals? And 17 can't you, as a result of all of these things that you've done, do 18 any better? And we said we'd go off and think about it. Being good 19 bureaucrats, we didn't give them an answer right away.

20 And the answer is, Yes, we think we can do something 21 about it. And part of what I have in the next couple of slides is 22 part of what's going to be involved in that process. Some of the 23 other things that are involved is the consolidated guidance. Many 24 of you by now are familiar with the new reg 1556, a series of 25 documents.

266 1 It is, if you will, the Ragu sauce -- it's in there, all 2 that good stuff. Ideally, everything that you would need to know 3 for a particular kind of application, in order to apply for it, 4 including: all the reviewer notes, everything the reviewer was 5 going to ask, everything you needed to know, the references to the 6 regulations, and a whole series of things in the back that if you'd 7 wanted to do the cookie cutter approach, there was one acceptable 8 way to do it. One acceptable way. A little bit like a regulatory 9 guide in that sense but a lot more than that.

10 Also went through and developed and refined a little bit 11 more -- and I'll talk about it in a minute in terms of performance 12 indicators -- again, some measures to try and judge how well a 13 licensee was or wasn't doing in their program and their activities.

14 And then earlier this year brought together a number of 15 my folks from the regional offices and sat them down and said, 16 Folks, here's your challenge. I want you to come up with a way that 17 we can deal with this mountain of renewals that's coming in and do 18 it for about half of the resources that you've got budgeted right 19 now. And after they all collapsed on the floor and then spent about 20 the next two days arguing as to why the division director could 21 possibly be that crazy, they came up with several other ideas, and 22 that's what we're going to talk about.

23 First, the performance indicators that, for the moment, 24 we're going to be using as an initial screen on some of the 25 activities; certainly the enforcement history of the licensees.

267 1 Have we, during the inspection process, found weaknesses that we've 2 had to take enforcement action, particularly escalated enforcement 3 action? If so, they're automatically going to get a harder look.

4 Now, some of these others you might say, Well, wouldn't 5 they all show up in enforcement? Well, possibly, but culling out 6 the specific things: losses of material; control in the program; 7 the kinds of things that you worry about in terms of radioactive 8 material running around. You know that the NRC got really sensitive 9 to control of material as a result of a couple of wonderful little 10 incidents with folks who decided they wanted to use the radioactive 11 material, in this case P32, for something other than a pure DNA type 12 of experiment.

13 Unauthorized disposal or release of material -- are 14 they -- this is the other half of the control if you will -- are 15 they properly handling the material, disposing of it, keeping track 16 of it, dealing with those issues and otherwise? And how are they 17 dealing with exposures, particularly have they had any situations of 18 overexposure otherwise, which would cause us to immediately want to 19 do a more detailed look in the process? If they haven't tripped any 20 of those then what we are looking to try and do is to have what we 21 have nicknamed for the moment a more limited review.

22 Larry, when he was still a branch chief in my group, had 23 nicknamed it light, but you can add various other names behind that.

24 You sort of get the notion of -- but his would be the light review:

25 less cumbersome, less resource intensive, less detailed, less

268 1 prescriptive perhaps, and of course associate with that one some 2 risks. We will talk about that in just a second.

3 So what are the things that we probably want to look at 4 when someone was submitting a renewal application? They passed the 5 indicators so they were in pretty good shape there. So are there 6 any administrative items? Have they changed anything that they 7 haven't picked up on amendment? That was one of the real 8 concerns -- was our licensees have in the past tended to sort of 9 bundle some of these changes they want to make if they knew a 10 renewal was coming up. That used to be driven very much by fees.

11 Much less now because the amendments and in fact now the renewals 12 are no longer charged separate fees. They're all wrapped under the 13 annual fee now, so there may not be nearly as much of that as we 14 thought there was going to be.

15 Program management, the pieces of the program that are 16 still in place -- a recheck, make sure that the pieces of the 17 program are still there. Are there any particular changes? If they 18 haven't made any changes, you can go on very quickly.

19 The equipment and facilities -- have they identified 20 anything different from what we've seen before, what we've looked at 21 before? The environmental -- if there's an environmental assessment 22 that's going to have to be done, they're going to have to kick back 23 out of the light process, because when you get involved in the NEPA 24 and the whole series of things we have to do, that throws you in a 25 whole different space of activity. Thankfully, we don't have very

269 1 many of those; and actually, only a couple a year that actually we 2 end up having to do assessments on.

3 Any previously unreviewed requests or new things that 4 they want to do, if they want to add iodine to what previously had 5 just been unidoses and stuff -- okay. That's going to require a 6 little more look because there's additional pieces of the program.

7 Or if they want to get into seal source therapies, if they want to 8 get into HDRs or other things, or if they're going to add a Gamma 9 Knife, it seems rather intuitive that we're going to want to take a 10 little more look if they're using this opportunity.

11 Any changes in the control, the management structure --

12 these days we're finding that more and more people are being bought 13 by more and more people, CBS-Viacom being sort of the latest 14 mega-example, but lots of that going on, and wanting to assure that 15 the right kinds of ownership and control issues, particularly for 16 those who might have the financial assurance. And then if there 17 were any other significant areas that needed a look -- now, a lot of 18 that could be done very, very quickly: click, click, click, check 19 it off, see where the pieces were in the particular process.

20 We circulated back now several months ago, actually I 21 think back earlier in the summer, a draft policy and guidance 22 directive. I was letting my regions comment on it. I asked Paul to 23 send it out to you folks in the states to look at it. I know that 24 Illinois and Washington at least have sent me some comments, and I 25 very much appreciate that. Perhaps some of the -- others of you

270 1 have brought along some comments. If so, we'd very much like to 2 have those because we have not finalized that document yet, although 3 we will need to shortly.

4 That guidance document was to provide the overall 5 structure for the reviewers to use. We are in hopes that the 6 renewals as well as new actions and things that are coming will 7 follow the 1556 format, and in fact, we're trying to dream up some 8 ways to encourage people to do that. We've already got a little bit 9 of a hint -- and Doug Collins from Region 2 tripped me up to this 10 one -- that there was no real incentive to the consultant's advising 11 a lot of our little licensees to change, because if they did it it 12 would be simpler so they wouldn't get as much money from the 13 licensee to go back through and do the action.

14 So we're going to have to find a way to change the 15 culture out there, because we want as many of these as possible to 16 come into the new format, take advantage of the new systems.

17 We have, within the Agency, had a long-standing system 18 of technical assistance where if a unique activity came up, the 19 regional reviewers would get headquarters involved in the decision 20 process. We've now focused that very much in the context of, if 21 you've come up with a new issue, what was it in the 1556 volume that 22 wasn't there and what's the proposal, and the answer coming back in 23 terms of an amendment or an addendum to the 1556 volume, if it 24 applies to other than a very unique circumstance, to try and keep 25 those documents to be living documents.

271 1 Another couple of things: all of the seemingly 2 intuitive and not necessarily anything unique -- but to reinforce 3 that if you want to do this quickly and effectively, why don't you 4 walk down the hall and talk to the inspector who went out there? He 5 can probably give you some insights in just a couple of minutes, or 6 she, on what they saw and make it a lot easier to figure out where 7 they are in this process. To try and increase the use of meetings 8 and visits where there are significant activities going on, 9 particularly if we're in a full review process, new activities, can 10 quickly understand what's going on.

11 A number of different ways to try and simplify 12 communications: e-mail is a wonderful thing. We can take the 13 e-mails, we can docket the e-mails. You can get them into the 14 system very nicely. Wouldn't it be nice to just have electronic 15 submission? It's coming one of these days, but I'm not going to 16 hold my breath. Turning blue isn't really my style.

17 Trying to limit our request for information to one 18 round, as in reviewer, go through, do the entire review, put it all 19 together in one package, make sure that what you're asking for is 20 really needed, and then go out once and try to make it very clear to 21 the licensee what it is that we're looking for, why it is that we 22 need to have it, so that we only go through this loop once. Another 23 one of the things we discovered was that we were having a wonderful 24 field day with back and forth and back and forth, because -- and 25 what we discovered was in the process we were slowly ratcheting

272 1 ourselves along, because we could think of all these wonderful neat 2 questions.

3 The test now is what about what's in 1556 do we really 4 need to have an order to take this action, as opposed to what other 5 nice thing might you be able to dream up? And then at some point 6 just to cut to the chase and say, All right. Here's a licensed --

7 this is the way it needs to be and get the agreement and move on, to 8 be able to issue the actions. And you'll say, Well, what's all new 9 in this process? Perhaps nothing is an epiphany of a brand new 10 activity.

11 But what it is is an attempt to really focus and refocus 12 ourselves on being efficient, moving quicky through the process, 13 communicating clearly with our licensees what we need to have, 14 setting the expectations up front so that what comes in is a lot 15 higher quality, and therefore be able to do this. We're in hopes 16 that instead of having the budget that we had before, which was 17 about .14 FTEs per renewal action, that if we can kick a light 18 review for something on the order of .04 or so, which is just 19 slightly more than what we burn on a typical amendment sort of 20 action -- so it's a little more than that but less than a new 21 action, because conceptually, if you know the licensee is performing 22 well and all you're looking for are changes, why is it that you 23 should spend more resources to do an action than you would to review 24 a brand new application?

25

273 1 How successful am I going to be? I'll tell you in about 2 two years. Questions?

3 MR. CAMERON: Don, why don't you have a seat, and then 4 we'll have a discussion on this issue?

5 Kathy, why don't you go ahead?

6 MS. ALLEN: When we got this draft guidance document, I 7 thought it was pretty interesting. A lot of the stuff that's in 8 here are things that states are doing already without really having 9 written it down. Many states don't go back and forth multiple times 10 with letters. Mostly, we've come about because we wanted to be 11 efficient, so I thought those were some pretty good ideas.

12 All of us are looking at crunches, financially. We're 13 all looking at better ways to improve service to the customers, 14 which would be the licensees, and better ways to manager our staff 15 and our time. We've got training issues -- it doesn't matter what 16 size state you're from. You don't have unlimited resources. So you 17 want to spend them the best way you can.

18 Now we're 31 Agreement States. There are 31 different 19 ideas out there. We're all adequate. We're all compatible, but we 20 all have slightly different ways of looking at things. Some of it 21 works great for our states and others -- it may not work well in 22 your state. But what we seem to be missing through some of these 23 meetings was a chance to discuss or come up with ideas, listen to 24 pros and cons of different ways of doing things, and just kind of 25 have a discussion about where you might be headed.

274 1 For example, a state may come up with a way of doing a 2 license issue -- sorry -- a renewal or a new amendment or changing 3 expiration dates, and they might have come across some pitfalls that 4 they'd like to share with others that might be considering the same 5 thing. That's what this whole forum is about. It's a great chance 6 to get together and share ideas and share ways of doing things so 7 that we don't all hit the same wall every time we try and reinvent 8 the wheel.

9 I sent out an e-mail to people to give them a chance to 10 take a look at Don's draft policy and guidance directive -- and I 11 have a few extra copies if anybody needs it -- and asked you to take 12 a look at what you're doing and come forward and have some ideas to 13 share and suggestions. And people have sent me some e-mails and 14 jotted me some ideas down, so if you don't speak I'll poke you. But 15 that's pretty much how we wanted to set this up as more of a 16 discussion type thing.

17 MR. CAMERON: Okay, great. Thank you, Kathy. And thank 18 you for the thought beforehand in terms of questions that might be 19 relevant to this. And let's go along in the spirit that Kathy laid 20 out for us.

21 Cheryl, I think you had a question?

22 MS. ROGERS: Cheryl Rogers, Nebraska.

23 The old way we used to -- or we still do renewals, if 24 absolutely nothing changes, theoretically, or at least in our 25 procedures, you can do a short form renewal. And the way we do that

275 1 is, We want your name and your address and your radiation safety 2 officer, and then the certification. And that's what our standard 3 short form renewal is. The advantage of that, as I see it, is you 4 don't have a bunch of stuff come in that's -- they're still 5 committed to the same procedures.

6 And so it looks like the change here is you would in 7 fact get a new package of information. And what makes me nervous 8 about that is, being a good little reviewer, I want to see 9 everything that's in it. And so I guess that's my question for Don 10 and Kathy.

11 MR. COOL: Good question, and it's a mixed answer, quite 12 frankly.

13 We don't necessarily have exactly the same sort of 14 things in terms of short form. But you can fill it out, you can 15 reference the previous material, and you can -- almost the same way.

16 And if folks choose to do that, we're going to do that very quickly 17 and try to look at that.

18 What we find ourselves doing is attempting to walk a 19 little bit of a tightrope, because what I would really like to do is 20 do them all very quickly, but I would also like to move them all to 21 the standardized 1556 format. And so I actually find myself trying 22 to encourage the licensee to take the time to look at their program, 23 because they probably haven't looked at it for almost ten years, 24 because most of them have effectively had a ten year license at this 25

276 1 point. Look at what the guidance is. A lot of them have had 2 changes to the regulations.

3 Part 34 has changed since the time most of them have 4 been reviewed. Part 35, cross some number of fingers, may well be 5 changed before a lot of them have to be done, the new irradiator 6 regs -- and to update and simplify the action simultaneous with 7 that. And so I've got this little balancing act and yes, you're 8 right. Those two are not in exact alignment in terms of their drive 9 on the resources and the need. And one of the big issues is, yes.

10 If they submit me a bunch of new stuff, somebody's going to have to 11 take at least a quick little scan and make sure they didn't sneak 12 something in on us; the old grad student trick of putting the 13 constitution in the middle of the paper to see if the professor 14 reads it.

15 MR. CAMERON: I wondered how Don got through school.

16 Kathy?

17 MS. ALLEN: I'm curious. Does any other state to a 18 short form renewal, or do you do -- does every state here look at a 19 complete entire renewal? Does anybody else do an abbreviated 20 renewal?

21 MR. CAMERON: Yes, sir? And please identify yourself 22 for the transcript, too.

23 MR. MYERS: Texas right now is in the process of phasing 24 out I think what I interpret is your short form renewal. We used to 25 do a full renewal and then a renewal by letter. If nothing changed

277 1 in the program then we'd alternate back and forth. We likewise have 2 extended out the length of our renewal periods, with the intent of 3 eventually eliminating those renewals by letter. So eventually 4 we'll go to all renewals in entirety.

5 MS. ALLEN: And what time frame is that? Is that five 6 year, or -- it was five years and now you're going to ten, or --

7 MR. MYERS: No. We went from a five year renewal to a 8 seven year renewal for most licenses. For the real simple ones, 9 pacemakers, things like that, ten year renewals.

10 MR. CAMERON: Okay. Thank you. Ken?

11 MR. WANGLER: If by the short form you mean allow them 12 to just incorporate by reference into their renewal application, we 13 do that. They can reference other material they've submitted to us 14 previously.

15 MS. ALLEN: How many times can they do that? Is it 16 just --

17 MR. WANGLER: Well, probably indefinitely, as long as it 18 hasn't changed. We do ask that they be specific. If it's part of 19 their operating and emergency procedures, we ask them to give us the 20 section fairly clear so that we understand that what they're 21 referencing is in fact what we're looking at and assuming it to be.

22 But we allow them to reference previously submitted 23 material.

24 MR. CAMERON: Okay. Joe?

25

278 1 MR. KLINGER: Cheryl, is there -- do you look at the 2 inspection history on the short form business, because what we're 3 considering is -- we're trying to take a fresh look at this whole 4 process. We've all gone this five year thing -- and resubmit 5 everything in its entirety and all that. And I've always been 6 committed to that, but now I'm trying to be more open-minded.

7 And I think the licensees get a little frustrated 8 because -- most of them are good, and if they have a good inspection 9 history, it would be nice to reward them in a sense and look at 10 their inspection history. If they've been really good, compliant, 11 et cetera, and nothing has really changed, then we're thinking about 12 going with the short form. And it will save us a lot of hassle. It 13 will same them a lot of problems, and it rewards them for being good 14 operators. And so -- plus it injects more efficiency into our 15 system.

16 So I'm just curious. Maybe other people ought to take 17 that in mind, because throughout my career I've had so many people 18 say, like after an inspection, Well, tell me something good that 19 we're doing, because you only put down the bad things. And so this 20 would be a way of recognizing good programs and saving them and us 21 some money.

22 MR. CAMERON: Cheryl, do you want to comment?

23 MS. ROGERS: Real quick. We do make a decision about 24 whether we're going to send out a short form renewal or the regular 25 renewal. So at that point in time is when we're supposed to look at

279 1 it and see if the inspection history is good or bad. And it's very 2 difficult to actually find somebody who doesn't -- who meets that 3 qualification right now, because we have it so tight that virtually 4 nothing can change.

5 MR. KLINGER: Uh-huh.

6 MS. ROGERS: But the question, I guess, goes back to 7 Don. It sounds like you guys wait until it comes in to determine 8 whether you're going to do the limited or the comprehensive review?

9 And then it leads me back to that original question of if you have 10 this whole package of information, then you are obligated to look at 11 it.

12 MR. CAMERON: So is it -- there could be a difference 13 between the short form that you two were talking about and the 14 limited review concept that Don was talking about?

15 MR. COOL: Yes. There's very much a difference. Yes.

16 We're letting them submit the package. We debated the question of 17 doing a review before and then have it come in.

18 We concluded that -- because another one of our steps is 19 an administrative review, a quick look by the licensing assistant or 20 one of the reviewers; a quick check off of what's there, what's 21 changed. The very cursory bin it -- that is was more efficient to 22 go ahead and have it come in, have us bin it, because we would need 23 to do that in any case, and be able to toss it in one of the bins 24 than do a review, send it up, come back, and in essence have to warm 25

280 1 back up again because it would have been some period of time, and 2 most of us have memories that don't quite hold that long.

3 MR. CAMERON: Stan, did you have something you wanted to 4 say?

5 MR. MARSHALL: No.

6 MR. CAMERON: Okay, Bill?

7 MR. MARSHALL: Well, yes, I do. It's a question for 8 Joe. It relates to your thing about waiving the extended review 9 based on a good compliance history.

10 Let's say a licensee has paid a consultant to come up 11 with a pristine, perfect application that's flawless, but yet 12 there's management disconnect, something that's not even related to 13 the application, not even related to the procedures package, do you 14 draw a line on what -- for instance, if there's management 15 disconnect that has nothing to do with details of an application, 16 why can't you allow a short review with a management disconnect 17 compliance problem, or other things not associated with an 18 application?

19 MR. KLINGER: Yes. And this is something that we're 20 just considering right now. We're not doing. But I think rather 21 than have them submit an application for renewal, like what Don's 22 talking about, I like what Cheryl's doing. We can make that 23 decision.

24 We send out notices about four months prior to the 25 expiration date. And at that point, we look at the inspection --

281 1 this is something that I think is very easily done -- we look at the 2 inspection history because that's really where the rubber meets the 3 road, is how are they performing out there? Just look at the 4 inspection history. If they're good performers, why hassle them?

5 Just go back to, If you're a good performer, here's an option for 6 you.

7 And the option would be if not much has changed or 8 essentially nothing has changed, you certify to us that that's the 9 case, and you've got a good inspection history or else we wouldn't 10 be giving you this option, and you certify, sign, and say nothing 11 has essentially changed. You come back to us, we're happy.

12 Now, if there were management problems then we would be 13 aware of that, so we would be hesitant to offer them a short form 14 like that. It might be some sort of an abridged complete renewal, 15 something focusing on those management problems or something like 16 that. It's still conceptual at this point, but I think it has a lot 17 of potential.

18 MR. MARSHALL: That's a good answer. That's a loaded 19 question for you. At the time of advising a licensee in Nevada that 20 they're about to come up for renewal, we are looking at things. We 21 are beginning license review at the time we are advising them, at 22 two or four or six months in advance, because if there's a nasty 23 compliance record, we're looking at them six months in advance to 24 even decide if we're going to allow renewal. I mean, we're going to 25

282 1 get serious about it because the shape and form of the renewal 2 advisory is based on several things.

3 We could get down to two months before renewal with 4 someone with good compliance, allow a short review, and we save a 5 lot of resources.

6 MR. KLINGER: Sure.

7 MR. MARSHALL: You can't wait to the very end of the 8 application hitting the desk to decide whether you're going to do 9 short review or not. You have to do it way in advance of that.

10 MR. CAMERON: Okay. Let's go to Bill, then we'll go 11 down to Jake and across to Aubrey. Bill?

12 MR. DUNDULIS: Overall I think this has some potential, 13 but I see some back to the future complications.

14 About 15, 16 years ago, when Rhode Island started doing 15 the first renewals of licenses we'd inherited from NRC, we found 16 many instances of references to documents that had already been 17 renewed several times under NRC that neither the material we 18 received for NRC nor the licensee actually had letter dated 5 March, 19 1965 any more, and the only people that knew what was in that letter 20 had long since retired. So that's something to be aware of on how 21 many times you can just reference previous submissions.

22 And then the second thing is even in those cases when 23 somebody did remember what was in that letter, it contained 24 materials or reference to stuff that was either out of date, 25

283 1 supplanted, or was a roster of people, all of whom were dead or 2 retired.

3 So I think those are the pitfalls that you have to kind 4 of do a reality check, that if documents are included there could be 5 some sort of ability to show that in fact, yes, those documents can 6 be resurrected.

7 MR. CAMERON: Okay, Don. I see you shaking your head 8 affirmatively. I guess we've tried to -- we've encountered this 9 problem.

10 MR. KLINGER: Violent agreement.

11 MR. CAMERON: All right. Okay, Jake?

12 MR. JACOBI: I had two comments. First is to also agree 13 with what Bill had just said, but that braves the question of if Don 14 finds that people Xerox previous applications and reference people 15 who are dead, why does he think he can go to a short form? Does 16 there seem to be -- if you don't get the right information, if they 17 don't know who's on their staff and they don't look at what they 18 submitted before, they obviously can't know what they're doing.

19 And that's why we require a complete new application.

20 We got tired of having dead people referenced to safety officers.

21 The second comment is on Joe's, where he says he looks 22 at compliance history. About ten years ago, we instituted a policy 23 that if people have a great compliance history for the last two 24 inspections, we'd extend their inspection schedule. And we found 25 there are three things that determine a current compliance more than

284 1 anything else, and past history is not one of them. The three 2 things that we found were really key was a new radiation safety 3 officer, the existing safety officer having been assigned additional 4 duties, or we have changed our regulations and they didn't know 5 about it. And it had nothing to do with past compliance.

6 So I would say the only way you're going to have -- can 7 use compliance history for anything is if you know you've got the 8 same RSO, his duties haven't changed, and you haven't had a major 9 regulatory change.

10 MR. CAMERON: I think those are useful points to 11 consider.

12 Aubrey?

13 MR. GODWIN: Just sort of a note to folks -- if you 14 don't come up with an efficient system, there are folks who will 15 help you devise one. There is -- the Legislature, getting tired of 16 some agencies' sitting on license applications for a long period of 17 time, instituted a requirement for all agencies to set time frames 18 to issue their documents. Specifically, you have to set a time 19 frame in which you say you will get the license, permit, whatever it 20 is, out the door. If you don't do it, they take away your money.

21 We've been in this process a little over a year now. We 22 do a full review -- or full application. We don't do a full review 23 necessarily. And we're able to get them out and meet our time 24 frames. For materials program, most of the time frames are in the 25 90 to 120 day time frame. Our average out the door time is 27 days.

285 1 There are some exceptions. If we had a little redirect 2 of waste site, we have four years unless somebody thinks we've gone 3 crazy. It does vary by the complexity of the license. You are only 4 allowed one round of questions after it's determined to be complete.

5 You can ask all the questions you want to make sure that it's 6 administratively complete, but once it is complete you're only 7 allowed one round of additional questions.

8 If you do not have adequate answers and you cannot 9 certify its health, then you must deny or issue. Take your choice.

10 MR. CAMERON: Okay. Kathy, do you want to --

11 MS. ALLEN: Aubrey, if you get in a poor application, 12 can you deny it outright, or do you go through the review process 13 and do a detailed letter of everything that they're missing?

14 MR. GODWIN: We first determine if it's administratively 15 complete, and that means did they address all the items on the 16 application. If they did, then we would do a review and send them a 17 series of questions, just like you've probably done all along. We 18 would not go to the extent that we basically become consultants to 19 them.

20 We'd say, You did not address this issue. You must 21 supply the material to show that you understand, and then they'd 22 have to work it out.

23 That probably would be an administratively incomplete 24 application if we had to do that, so -- once you raise the question 25 in writing -- and this is something else that's very important --

286 1 the questions must be raised in writing to the applicant. Telephone 2 calls do not count. We've had untold staff anguish over the fact 3 that, Well, I called them and told them to send in the information, 4 and they didn't send it in.

5 Well, we may catch you, so we only had three that didn't 6 make the time frames, and we had to pay $1.20 penalty to the General 7 Fund and $120 back to people who applied. So we've been able to 8 keep it pretty well under control.

9 But the point is, once you show the question to them in 10 writing, the time stops until you receive their response. Did that 11 answer your question?

12 MS. ALLEN: Uh-huh.

13 MR. CAMERON: Okay. Tom?

14 MR. HILL: We do most all of our renewals, complete 15 applications, complete reviews -- but we do have provisions for, 16 quote, short or light reviews.

17 And occasionally we do get applications in -- they'll 18 fill in the form, say nothing has changed on all of our procedures.

19 Everything's the same, et cetera. And we can look at that and agree 20 with it.

21 But we also have a provision in the rules and 22 regulations that if they want to reference any previous submitted 23 documents, to please be specific by date and page and paragraph, if 24 necessary, so that we have some assurance there that they have at 25

287 1 least reviewed what they've submitted to us before and we're not 2 getting any dead RSOs submitted, for example.

3 MR. CAMERON: Okay. Thanks, Tom.

4 Kathy, is there some other things that you're looking 5 for?

6 MS. ALLEN: Well --

7 MR. CAMERON: Roland. Sorry.

8 MR. FLETCHER: I just wanted to piggyback on what Aubrey 9 was talking about, because Maryland has instituted -- at least our 10 department, through legislation, has instituted some rather 11 stringent requirements on turnaround times from application to 12 issuance.

13 But it seems we have a little more leeway in that the 14 clock does not start until we declare that we have received all of 15 the information pertinent to the application. In other words, if 16 there are questions with the initial application, then we must have 17 those questions resolved before the clock stops -- before the clock 18 starts. And we were the ones who determine what would be an 19 adequate amount of time, so we're shooting ourselves in the foot if 20 we cut it too short. And our measure of success is that over a 21 year, we must have at least 90 percent of all the actions that we 22 did within the time frame we predicted.

23 MR. CAMERON: Okay. Stan?

24 25

288 1 MR. MARSHALL: Question for anyone. Is your licensing 2 renewal process complicated by a required inspection relative to 3 renewal? Is anyone facing that?

4 MR. CAMERON: Are you facing that in your state, Stan?

5 MR. MARSHALL: No. We've pondered it though, relative 6 to certain categories of licensee that have -- if you're on an 7 annual or two or three year cycle with something and you haven't 8 been there in a while, and here you are facing a five year renewal 9 of somebody that's got a questionable recent compliance history, and 10 you're strapped with a situation like Arizona where an application 11 has hit the front door and you've got to get on with it, and in some 12 western states they're a long way from the home office, you can feel 13 like you want to reinspect along with a renewal review --

14 MR. CAMERON: Any comments on the required reinspection?

15 Terry?

16 MR. FRAZEE: It's not so much that it's a required 17 inspection, but we do something in our state that probably can only 18 be done because we're a relatively small state, and that is our 19 license reviewers are also inspectors. We also have a compliance 20 staff as well, and so the licensee is being inspected basically 21 every other time by a license -- by the license reviewer, so that 22 when renewal time comes around, the license reviewer has a real good 23 handle on the licensee's facility and compliance history, because 24 they've been really a part of the process. And we feel that's 25 worked out very well.

289 1 Going back to something that was said earlier, about ten 2 years ago we did try the one-page, check here if nothing is changed 3 and we renew the license, and we got away from that real fast. And 4 that's primarily because we're real intent into inspection: being 5 there, seeing what's going on. And so it just never sat well with 6 the inspectors to see this one-page certification, which it turns 7 out is just -- I'm not sure we had any dead RSOs listed, but it was 8 that kind of thing, where -- not successful at all.

9 And we also do a -- most of our license renewals are 10 actually complete applications that we've prepared, and so we're 11 very familiar with what's in the application because it's our 12 application that we're sending out to the licensees. And if they so 13 choose, they review it and sign the bottom line and agree to follow 14 the conditions, and then it makes it much easier for us when it 15 comes back in because it was our application. We already know it's 16 a good application. Much easier than if they submit totally fresh 17 renewal with their own consultant's versions of what they think is 18 right.

19 MR. CAMERON: Okay. Thanks, Terry.

20 Richard, and then we'll go to Ed.

21 MR. RATLIFF: In fact, Terry hit on the question I was 22 going to ask is -- just a show of hands of how many of your people 23 do both licensing and inspections? But because Alice and I were 24 talking a lot.

25

290 1 Our legislature has a unique thing. They've told the 2 state agencies that they want less people in Austin, and we're faced 3 with how we're going to handle a lot of things. And so it's going 4 to be trying times for us.

5 MR. CAMERON: Is that a historical artifact, that 6 licensing and inspection staffs are separate, or how are decisions 7 reached on combining those two functions? Ed?

8 MR. BAILEY: We've talked a little bit about the 9 licensee not changing anything, and I'm wondering how many of you 10 are impacted by the license reviewers changing? And over the years 11 that the license has been in existence, there's been a -- maybe not 12 an overt change to the way you interpret and enforce things, but 13 over the seven years or five years or whatever, your standards have 14 oozed over and they're different.

15 And I don't do licensing, but my perception is there's a 16 lot of that that occurs on our staff, both from staff turnover and 17 simply from just oozing to different requirements over the years.

18 MR. CAMERON: Thanks, Ed.

19 Kathy or Don, any comments on that last couple of 20 statements?

21 MR. COOL: I found the word ooze interesting. I'd like 22 to think that when we changed the regs it was more deliberate than 23 that, but you might actually be right.

24 I think I would have guessed that the changes in 25 regulations might have had a greater impact than the individual

291 1 changes in reviewers. In a lot of cases, we make a more 2 deliberative attempt to not have somebody sort of become too close 3 over a period of time to one set of licensees, so we do some 4 changes. We're more overt about that in some of the bigger 5 programs, some of the fuel facilities where we make sure that 6 different folks are looking at it, just to make sure that the same 7 sort of blind spot doesn't show up multiple times.

8 MR. CAMERON: Okay. Thank you, Don.

9 Larry?

10 MR. CAMPER: I headed up the task group that Don was 11 referring to that went through and prepared the approach that he 12 laid out today, and he mentioned a comment that was subtle but it's 13 very important, and it gets to some of the comments you made in 14 terms of can you ease up what they have to submit and what have you?

15 Bear in mind that this was part 2 of a process that 16 started with the 1556 series -- the new reg series. And the thing 17 that we did -- just getting at the ooze comment -- we actually went 18 through a deliberate attempt to avoid the ooze in the following 19 sense: we challenged the teams that wrote the 1556 series to make 20 each one of those guidance documents as much risk-informed and 21 performance-oriented as possible.

22 In other words, putting it differently, we believe that 23 in the past, licensees have submitted information to us for which 24 there wasn't a clear regulatory basis to ask for it. Particular 25 preferences of reviewers, although, well intended, had become very

292 1 prescriptive. And so we said, Look. Let's take each guidance 2 document and make it as performance-oriented as possible.

3 And when we go out this time to the licensees for 4 renewal, we're asking them to look at their program to make sure 5 that it's in fact current, to make sure you're listing an RSO that's 6 alive, for example, and to make sure that you are giving us an 7 application that brings to bear the new guidance, which gives you 8 much more performance flexibility. We wanted to do that and at 9 least get one round on the record that will hopefully be a much more 10 performance-oriented approach.

11 Now, the team -- we did consider the idea of perhaps 12 going to an abbreviated form, but we felt that so much work had gone 13 into and good effort had gone into the performance-oriented 14 approach, and with the emphasis on risk, that the licensee should 15 take the benefit of that, at least one time around. We can always 16 reassess whether we can go to an abbreviated form at some point in 17 the future.

18 So it really was part of a two-part approach, and 19 they're very closely married together.

20 MR. CAMERON: Okay. Thank you, Larry.

21 Ed, do you have a response to that?

22 MR. BAILEY: No.

23 MR. CAMERON: Okay. Joe, did you have something 24 connected, and then we'll come back?

25

293 1 MR. KLINGER: Yes. Just one statement. Instead of 2 ooze, I think it's like the mission creep that they talk about with 3 the military. And that happens to us, because the inspection staff 4 will say, Oh, my God, we're finding all these problems here. So all 5 the license reviewers -- they focus on this area. And then a year 6 later, Oh, my God. We've got problems over here. So we move over 7 here. It's this mission creep.

8 And so things do change, but still I think this 9 abbreviated concept can still work. I think it has some potential.

10 MR. CAMERON: Anybody else on mission creep or ooze or 11 whatever we're calling it?

12 MR. HILL: I was going to second that, because I see it.

13 I see it with staff and with individuals, and as their experiences 14 differ and additional ones -- these changes that occur.

15 But also, back to Don's comment, we started the first of 16 this year with assigning regions to all of our inspectors, and our 17 inspectors and license reviewers do both. They each have a set of 18 license now that they are responsible for all inspections and all 19 licensing. So our hope is that they will get to know these folks 20 better than they have in the past whenever it was just hit or miss, 21 whoever was the next one in the rotation to the licensing action, 22 and that they will be able to know what the changes are, know how 23 they're coming, and be able to work with them.

24 And I guess the bottom line is better customer service.

25 MR. CAMERON: Okay. Thank you, Tom.

294 1 Ed, for I think a final comment here?

2 MR. BAILEY: I want to apologize to this elite group for 3 my lack of vocabulary, but I guess one of the things I'm hearing --

4 and it's the thing that has come up in our state as we're going 5 through business process reengineering -- is that certain types of 6 licenses -- i.e., the gauges, both mobile and fixed -- the 7 procedures and the requirements are so set in stone that in trying 8 to think out of the box, we also remembered Pearce's admonition to 9 look into the box occasionally.

10 The suggestion was made, why are we licensing these 11 things at all? At the meeting with Greta Dicus the other night, I 12 brought up would NRC object if we simply took a class of licensees, 13 such as all gauges, and generally licensed them?

14 Now, you know I don't like general licenses, but take it 15 and simply almost treat it like a registration. Don't change the 16 inspection intervals at all, but cut down on all of this paperwork, 17 which -- we're saying, Hey. Does it do anything?

18 If you've got a two page set of procedures for mobile 19 gauges, why do we beat ourselves and the applicants up -- and just 20 simply call them all general licenses or come up -- I would prefer 21 to come up with a different name for them, maybe limited licenses or 22 something like that so it doesn't carry the stigma that general 23 license has in my mind.

24 But I think this is something -- as we simplify all this 25 stuff, we're missing a big opportunity just not to say, Okay. If

295 1 you've got one of these, you've got to file these two pages of 2 instructions, and here's your certificate. Go forth and do good.

3 MR. CAMERON: Okay. Thank you very much, Ed. I think 4 that's a good sort of closing remark for this particular session, 5 and I'd just like to thank Don and Kathy for their help on this.

6 Thank you very much.

7 And, Seth, could you come up now? We're going to go 8 back to the whole issue of performance-based, which I think 9 circulates around all of these topics that we're talking about. And 10 Seth Coplan from the NRC is going to talk to us about 11 performance-based regulation.

12 MR. COPLAN: Good morning. I'm Seth Coplan. I'm with 13 the Office of Nuclear Material Safety and Safeguards with NRC. And 14 as you can see, I'm using VuGraphs, which was my backup system here.

15 It turns out that my disk that would have done a nicer job, didn't 16 work, and that's consistent with the way I do a lot of things at 17 this hour of the morning. So I hope you'll bear with me here.

18 There were -- I'm going to talk about risk-informed and 19 performance-based regulation. There were several interesting talks 20 and discussions on the subject yesterday afternoon, and in fact, 21 they kind of reminded me of a story that I feel compelled to tell.

22 It's an old one. It's stale.

23 But the story's about a college professor who was 24 lecturing to a physics class, and he'd put an equation up on the 25 blackboard. And he goes to put the next equation up and he says,

296 1 Now, of course it's obvious that -- and he stands and he looks at 2 the second equation, looks back at the first equation, and gets this 3 puzzled look on his face, and tells the class, Sit there. Don't go 4 away. Picks up his books, papers, leaves the room. A half hour 5 later he comes back and he's got his jacket off, his tie loose, and 6 collar open, sleeves rolled up. He's covered with sweat and he 7 says, Yes. It is obvious that, and proceeds with the lecture.

8 I think that there's an element of that that goes with 9 some of the new approaches that people have been talking about for 10 some years now: risk-informed or performance-based regulation.

11 There are aspects of it that seemed very obvious at the time that 12 people started thinking in terms of the shifts, and now we're at a 13 stage generally of looking at, Well, is it as obvious as that after 14 all? And I'm inclined to think that we are eventually going to get 15 to a point where we'll be able to say, Yes. It's obvious. But 16 there's going to be some sweating that goes on in between.

17 I'm not going to presume to answer all of the questions 18 that were raised yesterday. I hope that I will be able to, during 19 the course of my talk, answer a few of them and give some tools for 20 dealing with the rest of them.

21 What I'm going to do is take a little bit more of a 22 philosophical perspective than yesterday's talks. I'm going to 23 start with some background on how we got into some of this, and I'm 24 going to talk about risk-informed regulation, what NRC means by that 25 and what we in NMSS have done and are doing in the direction of

297 1 moving toward more risk-informed regulatory approaches, and then I'm 2 going to wrap up with a similar but more abbreviated talk about 3 performance-based regulation.

4 Much of what we're starting to do had its origin with 5 reinventing the government. In fact, quite early during the Clinton 6 Administration, President Clinton issued an executive order -- it 7 was in September of 8 1993 -- that dealt with regulation and how it was to be reviewed in 9 the Office of Management and Budget when federal agencies issued new 10 regulations. And included in the executive order was a very strong 11 encouragement to do regulation that was focused more on outcomes, 12 less on process, to make sure that new regulations had benefits that 13 were commensurate with the costs, and so on.

14 Secondly, an aspect of this so-called reinventing was 15 Government Performance and Results Act. And one of the things that 16 that led to was the federal agencies were required to come up with 17 strategic plans for themselves, and these included strategic goals, 18 and the intention was that our budgets and our performance would be 19 judged by how we performed against these goals.

20 Some of you may recall that several years ago the 21 Nuclear Regulatory Commission went through such a process and one of 22 the issues that the NRC identified as an area that the Commission 23 needed to give some direction on in terms of formulating a plan 24 eventually was something that was called performance-based 25 risk-informed regulation. And the Commission, when it ultimately

298 1 formulated the strategic plan, gave some direction to the staff, and 2 this direction included three points that I think are of particular 3 interest.

4 First, the Commission said that we're not going to be 5 getting more resources in the future. We're going to have to make 6 do with what we've got or less. And in order to do our job right, 7 we need to be sure that we are focusing our resources and licensee 8 resources where the risk really is.

9 Secondly, the Commission told the materials program and 10 NMSS more generally that we want you to look at your regulations and 11 to look for opportunities where, with minimal additional resources 12 you can make transitions to more performance-based or risk-informed 13 approaches. Thirdly, they told us that -- oh. And in doing this, 14 before you get too far into it, We want you to develop a framework 15 for applying risk assessment in regulation analogous to the one that 16 the reactor part of the Agency had developed in 1995. And I'll 17 explain in a few more slides what was meant by a framework in that 18 context.

19 The first step for NRC, in going through some of the 20 sweating stage, was, What do we mean by some of the terms that we've 21 been throwing around, like risk-informed, performance-based? And 22 the Commission spent pretty close to a year developing a white 23 paper -- and I think a number of you have copies of it -- that 24 addresses, What do these terms mean? How do we regulate now? What 25 kind of transition are we planning to make, and so on.

299 1 For those of you that don't have copies, it's available 2 on the NRC web page.

3 The first thing that the Commission did in the white 4 paper was it defined risk. Well, people usually think of risk, at 5 least a lot of people usually think of risk, as a hazard times a 6 probability. And in fact, as I think people in this audience are 7 well aware, there's a very broad range of kinds of activities that 8 are regulated in the materials area, and that particular definition 9 is not necessarily applicable for all of them. And those who are 10 risk professionals some time ago realized that risk is more 11 complicated than that, and they've tended to work with something 12 that's called the risk triplet.

13 Risk triplet basically addresses three questions: what 14 can go wrong; how likely is it; and what are the consequences? The 15 first question is addressed in terms of scenarios, sequences of 16 things that can happen that can lead to something going wrong. The 17 second question, how likely is it, well, that's the probability 18 question. And finally, what are the consequences of the sequence?

19 Risk assessment is -- oh. And I should mention that the 20 more classic way of looking at risk as probability times consequence 21 is certainly encompassed in that, but so are a lot of other ways of 22 looking at risk. Then the Commission defined risk assessment. Risk 23 assessment is defined simply as being a systematic method for 24 addressing the risk triplet as it relates to the performance of the 25 particular system.

300 1 Automatically, I think a lot of people would start 2 thinking in terms of fault trees, event trees, complicated 3 mathematical analyses, and so forth. Yes, that's part of it, but 4 not all of it. And I think very important for the materials area is 5 that actuarial analyses of data are a form of risk assessment, and 6 perhaps a very powerful tool in the materials area.

7 And insofar as which is a better way to go, risk 8 assessment people think of things like fault tree and event tree 9 analysis as being a sort of predictive way of doing an analysis.

10 That's what you do when you don't have data or when your data are 11 very limited. When you really have data and you can start doing 12 statistical analyses of the data, that's better. It's more solid, 13 so that in fact, we may have quite a bit to work with in the 14 materials area.

15 But it's important to get the data set up right, make 16 sure that we're getting the right data, which I think was the point 17 of one of the talks yesterday. It's certainly an area that bears 18 more thinking.

19 A risk insight was defined by the Commission in this 20 paper as results or findings that come from risk assessments. Well, 21 by now you ought to be getting the idea that there's a lot of 22 flexibility that's built into all of these definitions. And so a 23 risk insight could be something like what's the probability of an 24 annual public exposure of 100 millirem from all radiography use in 25 the United States, or in Texas, or any of a whole variety of things?

301 1 Just something that comes out of a risk assessment -- an insight 2 into a system and how it performs in a risk sense is a risk insight.

3 And taking all that together, the Commission said, All 4 right. What's a risk-informed regulatory approach? Well, a 5 risk-informed regulatory approach is simply an approach that uses 6 such insights in making regulatory decisions together with other 7 things. And that's largely because these quantitative analyses, for 8 a variety of reasons, have uncertainties that are associated with 9 them that may leave you with a certain kind of an uncomfortable 10 feeling about drawing firm conclusions.

11 So the idea is that you use these insights as part of 12 your decision making. Don't rely on them entirely.

13 In NMSS, it turns out we've been using risk assessment 14 for quite a long period of time. In the waste disposal area, high 15 level waste and low level waste, we've been doing something called 16 performance assessment, which has a pedigree that's almost as old as 17 probabilistic risk assessment. We started doing all that stuff back 18 in the middle 1970s. And in fact, some of the techniques that are 19 used as part of reactor PRA at this point were originally developed 20 as part of high level waste performance assessment. So we've had a 21 fair amount of experience in that one area.

22 Another area -- about the same time -- I guess it was 23 the late '70s -- we did transportation modal study and generic 24 environmental impact statement on different modes of transportation, 25 and there were probabilistic analyses that went into both of those.

302 1 More recently, for the large fuel cycle facilities, we've started to 2 work an approach into regulation that evolved from the chemical 3 process industry as a result of the Bhopal accident.

4 And more recently than that, we tried to apply PRA to 5 the Gamma Knife, basically to see what would come out of it. And, 6 well, we found a couple of important things. One, that human error 7 was going to be the biggest source of problem and two, that fault 8 tree, event tree methodology is not a very effective tool for 9 dealing with that, and we knew that beforehand.

10 We've done some things recently. We did establish the 11 framework that the Commission asked us to do. There's a Commission 12 paper that's available on the web that describes this framework, and 13 in essence, what it does is it just provides a logical framework to 14 be sure that when we start thinking about changing a regulation to 15 make it -- or a regulatory approach really, to make it more 16 risk-informed, that we do it in a way where we make sure that we're 17 cognizant of all of the benefits, all of the reasons that we have 18 the current regulation in place; that we look at what's to be 19 gained, if anything -- and there may not be anything -- by going to 20 a more risk-informed approach.

21 And then taking those two things and doing a synthesis, 22 which may result in very substantial things or it could result in 23 deciding to stay pretty much where we are. But it would be 24 something to look at, area by area, activity by activity.

25

303 1 We also recently published the "Nuclear Byproduct 2 Material Risk Review" for comment; the stack of new regs that's 3 floating around now for comment. And most recently, we established 4 a task force within the Agency that is to -- or within the office 5 that is to be the focal point for the effort of implementing this 6 so-called framework for NMSS work.

7 What's the task force going to do? We're starting with 8 two things in parallel here: some very early stakeholder 9 interactions of which, in a sense, this is the first one. In other 10 words, we're trying to let the people who are going to be affected, 11 who need to be involved in how this develops, know from the 12 beginning what we're doing, why we're doing it, looking for ways 13 that we can most effectively get input as to problems, how to 14 address such problems, and so on. And clearly, the Agreement States 15 as co-regulators are going to be one of the most important 16 stakeholders involved in this.

17 In parallel with that, I mentioned that we're going to 18 have to look activity by activity at changes that we might make.

19 Well, the first step then for us is going to be let's identify 20 what's there and try to get some crude idea anyway of, is this 21 something where there's any real promise of making it more 22 risk-informed and getting a benefit?

23 Getting a little more specific, what we're going to be 24 doing is, having identified such areas, haven taken a coarse screen 25 or put things through a coarse screen, for the things that are left

304 1 we're going to want to work with stakeholders through meetings, 2 workshops -- we're going to be setting up a website -- to look at 3 what's the regulatory benefit of a change? What kind of resources 4 are involved: our resources, your resources, licensee resources.

5 What risk metrics should be used? Remember, there's a pretty wide 6 variety of things that can be called a risk metric here. And what 7 are the appropriate ones for a particular area? What kind of goals 8 should be established?

9 And mention there that when we got comments on the 10 direction setting issue in connection with the Commission's 11 strategic planning initiative, the Agreement States offered some 12 comments. And among them was if you're going to go this way, you 13 ought to develop a safety goal. And the Commission, in giving us 14 direction on implementing this framework, told us, Develop safety 15 goals. So -- and we think it's going to be goals, not a goal, in 16 the materials area.

17 But that's got to be part of the process and it's got to 18 be done, we think, in a very open, very public way, with lots of 19 involvement from all the stakeholders that would be affected.

20 And finally, how do we use what risk insights we have in 21 this -- in doing regulation? The range, when you start to think 22 about it, is pretty wide. You can do things like, you can state 23 what the goal is and say, Licensee, you do the analysis and show us 24 how you're going to meet the goal. Or you can go to the other 25 extreme and you can do all of the analyses, do everything connected

305 1 with the risk insights, and develop some very, very prescriptive 2 regulations that enable the licensees to comply, but at least they 3 keep the licensee focused on the areas where the risk is.

4 So part of this process is going to have to be the 5 sorting out which areas are the ones where you give broad licensee 6 flexibility, which areas do you want to continue to be prescriptive, 7 which areas do you want to leave alone?

8 At this point, I guess I should mention too that we 9 expect this to be a pretty long process. We're figuring that 10 starting now, we will probably be looking at being finished some 11 time on the order of 2003-2004. There's a lot of effort that's 12 going to have to go into that.

13 Okay. Turning to performance-based approach, when --

14 just let me digress for a second here -- when the Commission first 15 looked at risk-informed performance-based, they had a comma between 16 them, the implication being that they went together like hand in 17 glove. One of the things that we've come to appreciate is that it's 18 not that way. It's risk-informed and performance-based, or 19 risk-informed or performance-based. They're somewhat different.

20 By a performance-based approach, the Commission means a 21 regulatory approach that establishes performance and results as the 22 primary basis for making regulatory decisions. That's pretty broad 23 and it's certainly a theme that went through the talks yesterday 24 that were addressed to performance-based inspections. But the 25 Commission went on from there and it has something really a little

306 1 bit more specific in mind for performance-based regulation. And to 2 identify what the additional specificity is, they decided it's got 3 to have four attributes.

4 First of all, you need to have measurable or calculable 5 parameters that can be used to monitor performance. That means that 6 you're doing something quantitative but again, you have a lot of 7 choice about what the quantitative measures are you may be looking 8 at. I was thinking, for example, in the discussion a little bit 9 earlier this morning that you can look at things like simply the 10 number of violations that a licensee has had during inspections as a 11 measure of performance that could then be used in turn to decide 12 whether or not you're going to use a short form for renewals or not.

13 So what you pick as the measurable or monitorable 14 parameter is pretty flexible. You have to have objective criteria 15 that you can use to assess performance, and here, you have to have 16 some way of picking these criteria. It could be done using risk 17 insights and then you've definitely combined risk-informed and 18 performance-based. On the other hand, you may base the criteria on 19 some of the much older ways of thinking about the problem; a more 20 deterministic approach, whatever.

21 Finally -- not finally but next -- and in a way it is 22 one of the more essential points of all this -- is licensing 23 flexibility. The point of this is, you're looking at how the 24 licensee performs. The licensee determines how they are going to 25 accomplish that. You don't tell them how. You don't give them

307 1 criteria for their process. They determine the process. And when 2 this system works best, there are incentives set up in it so that 3 the licensee is encouraged to improve their performance. In other 4 words, that they will use the flexibility that they've got to tend 5 to do better in the way they perform than they might otherwise do.

6 Finally, this is an approach where you don't want to 7 have a failure to meet your criteria result in an immediate safety 8 concern; in other words, to take an example from the other side of 9 NRC, where I think it's most obvious, you don't want to do 10 performance-based regulation where you're counting the number of 11 core meltdowns or something like that of reactors. You want to be 12 doing this at a level where you're not getting a threat to safety if 13 criteria aren't met.

14 We're at a pretty early stage at NRC in thinking through 15 issues on performance-based regulation. So I'm going to stop here, 16 and I'll be happy to try to deal with any questions.

17 MR. CAMERON: Okay. We're going to go to Ed Bailey 18 first.

19 MR. BAILEY: Somebody complained to me last night that 20 the meeting so far had been dull and non-controversial. When you 21 put up your definition of risk, you left out one component that a 22 sister federal agency of yours, staffed primarily by political 23 scientists and sociologists, always include in that equation, and 24 that's called public outrage. And it's an additive factor, as I 25 remember the equation. You take your equation plus public outrage.

308 1 And my experience, which is limited, has been that most 2 often in things nuclear, that probably has a hell of a lot more to 3 do with the outcome than the probability of something occurring or 4 the consequence of it occurring.

5 You mentioned two early efforts to look at risk 6 assessment or risk insight, whatever the new buzz words are. You 7 pointed out low level waste and shipping cast. Now, I don't know of 8 anybody that has been terribly successful in opening a new low level 9 waste site. The risk from one is pretty darn small, but the public 10 outrage factor totally overwhelms that other factor in the equation.

11 Another one you pointed out was shipping cast. Having 12 had my staff drive along beside some spent fuel shipments all the 13 way across the state -- again, public outrage was the real 14 determining factor. People didn't care if they were safe. They 15 didn't care if your mathematical equations said they were safe. You 16 hadn't taken into account the public outrage factor, and I -- all of 17 this sounds good to people who are science based, but it doesn't 18 sell in the community. And how can we get away from that?

19 We're going to have some meetings in San Francisco, and 20 I suspect that a presentation like this will give you -- about 90 21 percent of the audience are just going to say, Oh, well. We don't 22 care. So how are you going to address that in regulations, and how 23 are you going to factor that in in all of this risk-informed, and 24 who are you informing of the risk, and how effective are you going 25 to be in communicating that to the general public?

309 1 There was a question there, wasn't it, after the sermon?

2 MR. COPLAN: I wish I'd written them all down. They're 3 good questions. Let me start by taking the broader part of the 4 sermon, as you called it.

5 I think it's, in some ways, just a matter of how you 6 slice the problem. We're not oblivious to what -- I guess it's EPA 7 that's thinking about that. When you're in this business, I mean 8 the business that you folks are in, there are two sides to this.

9 There's one, assessing the risk, knowing what it is, and secondly, 10 there's how are you going to manage it? How do you regulate around 11 what you know about the risk? And at least at NRC, we think about 12 the first part of it as, Well, the risk assessment is this what can 13 go wrong, how likely, and how bad?

14 Now, what you do with that information after you've got 15 it is a whole different thing. Then you get into the risk 16 management side of things.

17 And on the risk management side of things, first thing 18 is -- you couched the question, Ed, in terms of who are you 19 informing? Well, when we use the term risk-informed, we're thinking 20 of informing -- we're thinking of it as a risk-informed process or 21 the approach. The process or approach is what's informed. But 22 getting to what I think was the intent of the question, we have got 23 to find ways of working with the public who have the dread and so on 24 for ways to put some of these concepts in place. And I've got to 25 say to me, there are no obvious ways to do that.

310 1 One thing that's clear to me, from having sat in on one 2 of the enhanced participatory meetings -- in fact, it was the one in 3 San Francisco -- is that people are so far apart on these issues.

4 You have licensees and industrial folks on one end that want to just 5 face it from the standpoint of, This is the technical reality of the 6 situation. We've got a business to run and you guys are responsible 7 for looking out for us to be able to do our business and for 8 customers to get products at good prices and so forth. And then at 9 the other end you've got the folks that are so scared of some of 10 this stuff that that logic doesn't apply, and that's where Chip 11 comes in.

12 MR. CAMERON: Where logic doesn't apply.

13 MR. COPLAN: Yes. Dealing with trying to create 14 situations in which you can somehow get constructive approaches out 15 of that kind of attention. And not obvious how you do it.

16 MR. LOHAUS: Ed has raised a very important and key 17 question, and what Seth is talking about is one part of a much 18 larger set of change initiatives -- I'll use that term -- that we're 19 undergoing at NRC. And one of the points that Seth had identified 20 is to define the goals. And we're wrestling with defining what you 21 may want to call top level goals in terms of where you want to 22 see -- what are the major areas of focus of the program in terms of 23 what we want to accomplish?

24 And when you look at the different areas -- and I'll 25 tell you what these goals are -- but when you look at the different

311 1 areas, what you look at is not only defining the goal but also 2 defining what you'd call a vector. And that is where should you be 3 heading with respect to that goal? Should you be doing less in this 4 area or should you be doing more? And when you look at those four 5 top goals -- the first one is protect public health and safety and 6 the environment -- when you hear these, they're basic common sense 7 kinds of things. That's the first one.

8 The second is reducing unnecessary regulatory burden.

9 It's really the question of trying to optimize what we're doing from 10 a regulatory standpoint to achieve the greatest level of protection 11 and providing a minimum burden on the regulated community. The 12 third is to improve efficiency and effectiveness. And the fourth is 13 public confidence, which comes to the point that Ed raised.

14 And when you look at a particular area, for example, if 15 we take the waste area, you may find that when you rank the goals, 16 protecting public health and safety and environment certainly comes 17 out as first, but what may come out as second in the waste area is 18 public confidence, because without the public confidence, there's a 19 significant impact and effect that that has, and you really need to 20 improve public confidence in that area. And the vector is, we ought 21 to be heading in the direction of trying to do more to improve 22 understanding: what are the relative risks that are involved in 23 that area, and try to do more to improve public confidence.

24 But when you look at this whole program planning 25 budgeting process, the Government Performance Results Act, these are

312 1 the kinds of things we're going through in trying to define the 2 goals, define the vector -- where should we be heading in that 3 direction -- defining strategies to achieve those goals, and then 4 the various tools that we would use in achieving those top level 5 goals -- and that's where I thought starting to share this 6 information and getting this out -- and a number of you have 7 participated in some of the stakeholder meetings. A number of you 8 have looked at a number of the documents that we provided.

9 But this is an area of change that we're going through, 10 and although individual states are going through similar types of 11 change, everybody's at sort of a different level in this process.

12 But I think it's important to get this out and talk about it and 13 have some dialog on that.

14 MR. CAMERON: Unfortunately, we're way over time so 15 we're going to have to limit comments now. But maybe one thing to 16 think about is, is it worthwhile to have a more -- for the NRC to 17 sponsor a more expanded session on this issue with perhaps a more 18 systematic agenda? I don't know.

19 Jake, do you have a comment?

20 MR. JACOBI: I just had two questions. One, I was 21 wondering is how effective NMED has been in looking at risks 22 associated with their licenses? And the other one is a new reg that 23 I looked at the other day which talked about perception of risks, 24 both normal condition and off-normal. And I noticed for a number of 25 modes it came out that they felt they were safer when they were

313 1 off-normal. And I was facetiously going to say, Well, how do you 2 indicate and regulate this? Do you tell people to start screwing up 3 so it's safer?

4 But as I thought about it, the real question is, why is 5 it perceived to be safer for these modes in the off-normal 6 conditions than in the typical operating conditions? And that's 7 something I think we need to look at as you go into the risk 8 evaluation.

9 MR. CAMERON: Okay. Thank you, Jake. And let's go to 10 Ed.

11 MR. BAILEY: Paul, I guess I had to respond to when you 12 did that ranking of those four things. I would say that we have 13 been so successful on the protecting human health and the 14 environment -- we have been totally, in my opinion, a dismal failure 15 in communicating to the public and building that confidence that in 16 almost all of our operations, if we really looked at it, that 17 protecting human health and the environment can be number four.

18 We're already doing that. And in getting the word out to the public 19 or building that confidence, it would almost be number one in each 20 of those -- any kind of process you look at.

21 And I'm not particularly liberal or social scientist or 22 anything, but this seems to be the real area where this organization 23 and all are really lacking. And I would encourage NRC, even though 24 I don't generally favor the way EPA does things, to look a little 25

314 1 bit more at that aspect of it and maybe improve it. The safety 2 record's pretty darn good.

3 MR. CAMERON: Okay. We have a recommendation that the 4 NRC should carry forward from this a risk -- some sort of a forum on 5 risk communication to address some of the outrage factors. And I 6 guess let's get to the Part 35, people.

7 Larry, do you have one quick thing?

8 MR. CAMPER: I think there's something -- to pick up on 9 what Ed was saying -- he makes a very good point in terms of the 10 perceptions of risk in the public, and one of the things that 11 troubles us very much today in the Division of Waste Management, the 12 commissioning arena in particular, is the question of finality. We 13 have this ongoing debate of 25 millirem and the licensing 14 termination rule, 15 millirem and 4 millirem for drinking water with 15 EPA. Mr. Chairman has gone on record as saying that the -- in a 16 letter back to the Congressional Oversight Committee that Congress 17 really ought to get involved and resolve that.

18 And it troubles me immensely in terms of the public 19 perception of risk and concerns about risk where the EPA, for 20 example, gets up in public meetings -- we had a meeting recently in 21 New England which Carl Paperiello participated in. The 22 representative from EPA made the statement that 25 millirem is not 23 protective of public health and safety. Now, the public looks at 24 this and they frankly don't know what to believe.

25

315 1 We had a workshop recently where we were discussing the 2 25 millirem decommissioning standard and a lady was there 3 representing the environmental concerns. And she basically pointed 4 her finger at me at the end and said, You know, NRC, you should be 5 ashamed of yourself. EPA is at 15 millirem. Some of the states are 6 moving towards 15 millirem. There's even talk of ten millirem. And 7 you really ought to be ashamed of yourself for thinking 25 millirem 8 because obviously 15 millirem is less than 25 millirem.

9 So getting back to your point, Ed, it seems to me that 10 there is value in talking about within the Organization of Agreement 11 States the pros and cons, the merits, and what have you of this 15 12 and 25 millirem debate, and helping to put that on the table as 13 another data point for consideration in this debate. Now, I don't 14 know now that's going to ultimately play itself out, but I am for 15 one very concerned about the amount of resources and time and effort 16 that we all put into this debate and how it's going to play out in 17 industry, and I'm extremely concerned about what it means to the 18 public.

19 And I don't think it does a thing to help their 20 confidence and it's got to be resolved and there's got to be 21 finality on this issue. But of course there's a whole bunch of 22 modeling considerations that go into that as well. But I think the 23 public confidence and taking some of that public outrage out could 24 be served if we could come to some kind of agreement on that debate.

25 MR. CAMERON: Okay. Thanks for that perspective, Larry.

316 1 We're going to jump into Part 35 at this point, and we 2 have David Walter and Cathy Haney with us. And, David, are you 3 going to start out for us?

4 All right. Let's pass that one down to him.

5 MR. WALTER: Okay. I can guarantee you I won't get us 6 back on time. But I want to give you a quick overview of what's 7 going on here in Part 35.

8 It's been over two years since the first meeting of the 9 NRC's Part 35 working group and now the draft final rule is out for 10 us to look at. So what's the same as the old rule, what's 11 different, and how is this going to affect us as Agreement States?

12 How will the suggested state regulations Part G reflect what we see 13 in the new Part 35? I want to talk to you about these topics a 14 little bit, because over the last two years I've been involved in 15 the working group process and have tried to incorporate the parallel 16 rulemaking process into the development of the new Part G.

17 So what is the same? When you read over the new Part G, 18 you'll note that a great deal of the rules are unchanged but there 19 are some others, like survey requirements, leak testing 20 requirements, aerosols and gasses, that are no longer actually in 21 the Part 35 rule but they're still covered in other parts, like Part 22 20.

23 And what do we have that's going to be different in this 24 new rule? The layout of the rule is very much changed. It's been 25 organized in such a manner that each type of use is stand alone.

317 1 This should make it more user friendly to the first time user.

2 There have been efforts made to simplify and clarify the wording 3 whenever we've been able to do it. Overall, it should be an easier 4 rule to follow and work with.

5 There's no longer a specific requirement for all medical 6 institutions to have a radiation safety committee. A licensee will 7 be required to establish a radiation safety committee only when they 8 are authorized to have two or more different types of medical use 9 which require a written directive. But when you look at the new 10 rule you'll notice that all the program requirements that were 11 previously in the rule and assigned to the radiation safety 12 committee are still required of the licensee. It's just that the 13 licensee is given the freedom to accomplish these requirements in 14 whatever manner they feel is best.

15 Although it's thought that most of the larger licensees 16 will probably continue to maintain a committee, many licensees may 17 incorporate the functions of the radiation safety committee into 18 other committees such as general safety.

19 The NRC has chosen to not require submission of written 20 safety procedures. Rather, it's their intent to review these 21 written procedures only when a problem is found during an inspection 22 that should have been addressed by one of these required procedures.

23 The words quality management program are gone but of course, there's 24 much of the old QMP still there.

25

318 1 But you've got to understand that the requirements that 2 the licensees submit a written QMP for review and that the licensee 3 perform an annual written review of the QMP are gone. This is a 4 good thing in my mind, because those two requirements were the most 5 burdensome for both the licensee and for us states. And they didn't 6 seem, in my mind, to increase radiation safety.

7 Rules that covers HDRs, PDRs, LDRs, and Gamma knives 8 have been added, and this should allow us to minimize the number of 9 conditions that we have to place on those types of licenses.

10 There's a new reporting requirement that's been added. It states 11 that a licensee is required to report to the NRC when an embryo, 12 fetus, or a nursing infant receives a dose greater than 5 rem. Now, 13 the NRC is quick to point out that this rule does not give approval 14 for doses to the embryo, fetus, or nursing child of up to 5 rem, 15 only that it's this dose which is a point at which you have to 16 notify the NRC.

17 So let's take a look now at the SSR Part G. What about 18 it will look the same as Part 35 and what will be different? First, 19 let's look at some similarities.

20 Formatting will be very much the same. This will help 21 us to maintain a flow between the two rules and it will make 22 cross-referencing between our rules and theirs much easier. And 23 much of the rule text will be the same as well, especially if you 24 have a compatibility category C or higher.

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319 1 So now, what are the major differences? At last year's 2 OAS meeting there was a discussion about Part 35, and during this 3 discussion a number of you commented that specific duties of the 4 authorized user should be detailed in the rules. Currently, the 5 definition of the authorized user includes reference to their 6 required training and experience and the only time that a specific 7 duty is spelled out for the authorized user is in 35.40, where it 8 says that the authorized user must prepare a written directive.

9 35.27 also says that the licensee shall require a supervised 10 individual to follow the instructions of the supervising authorized 11 user. But there's no reference in that rule to the duties of the 12 supervising authorized user.

13 35.27 will refer you to 35.11, and when you look at 14 35.11, it states that an individual may perform licensed duties 15 under the supervision of an authorized user as provided in rule 16 35.27. Does anybody else see the catch 22 here?

17 Now, as we know, there's very little, if any, radiation 18 safety supervision provided to a technologist by most diagnostic 19 nuclear medicine physicians. The fact is, if a written directive is 20 not required, there's no reference as to what the duties of the 21 authorized users actually are. If a written directive is not 22 required, the authorized user doesn't even know that a patient has 23 been dosed until the films show up on their desk. So it's the 24 referring physician that's taking on the medical responsibility of 25

320 1 the study and of the patient's radiation exposure and therefore, 2 much of the patient's radiation safety.

3 To be an authorized user, you must meet specified 4 training and experience requirements in the rule. Now, how many of 5 those referring physicians do you think meet those requirements?

6 And the simple answer is few to none. Does that mean that we have 7 rules that are being broken or we're not enforcing them? I believe 8 the rules should be more specific in regarding the duties of all 9 authorized users. If we expect the authorized user to make the 10 determination that a nuclear medicine study is appropriate, it 11 should be in the rule.

12 Do we expect the authorized user to prescribe the dose 13 of radio-pharmaceutical to a patient who's going to receive this 14 dose? Now remember, to prescribe the dose, the doctor at least 15 needs to know that the patient exists. And if we do expect that, we 16 need to put it in the rule. And for those who say it's the practice 17 of medicine and you guys stay out of the practice of medicine, I 18 say, You're darn right it's the practice of medicine. It's also the 19 radiation safety of a patient, and that's my job, and you can't 20 separate those two.

21 SR6 intends to have Part G require the submission of 22 written procedures for review by the state agencies. As simply 23 stated, I'd rather determine the adequacy of a written procedure 24 before a problem occurs. If you wait until after the problem 25 occurs, you're probably going to find out that no one knew that

321 1 there was a written procedure or it was never even done in the first 2 place. That means that each person would have been left to their 3 own in handling any given situation. And I don't believe that this 4 is in the best radiation safety interests of patients or 5 occupational workers.

6 What's more, the review and discussion of a written 7 procedure opens the lines of communication between the licensee or 8 prospective licensee and the state agency and allows the building of 9 a rapport between these two and can increase the confidence in both 10 parties in the resultant radiation safety program.

11 As many of you are aware, the patient release rule 12 subject is a very difficult one. On the one hand, you've got a 13 possibly small increase in exposure to the general public with a 14 tradeoff of lower medical costs and better patient morale. On the 15 other hand, you've muddied the radiation safety aspects of unsealed 16 source therapies by placing radiation safety into the hands of and 17 at best minimally trained patient and their family and led to 18 increased costs to state agencies who have no choice but to respond 19 to landfill alarms and deal with the resultant waste.

20 The heart of this matter is whether or not the training 21 given to the patient and their family is adequate and effective. If 22 it is and the patient truly understands why and follows through on 23 how to maintain exposures to others' ALARA and how to minimize the 24 waste problem, then this rule will work. If not, we end up with 25 unnecessary doses to the public and increased landfill alarms. And

322 1 judging from the increases in landfill alarms over the last few 2 years, it seems obvious that at least some licensees are not 3 providing adequate ALARA training or the patients aren't taking this 4 training seriously.

5 The revised Part G will offer the states verbiage that 6 will allow the release of patients, but it will try go assure that 7 the ultimate responsibility for radiation safety remains with the 8 licensee. Additional text will be included that requires the 9 authorized user to personally approve the release of a patient based 10 on their professional opinion that the individuals are adequately 11 trained and fully understand how to maintain exposures ALARA and 12 minimize the release of radioactivity.

13 We're also trying to come up with some text that gives 14 the regulating agency the ability to hold the licensees responsible 15 for confirmed excessive exposures and releases of radioactivity. In 16 other words, the licensee will have to handle the resultant waste 17 and might even be held fiscally responsible for the agency's costs 18 associated to responding to an incident.

19 As you probably heard, the NRC has essentially reverted 20 back to the old training and experience requirements for everything 21 except the use of radio-pharmaceuticals in therapy. Here, they've 22 increased the required total number of hours of training from 80 to 23 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />; that is for everything except the oral administration of 24 Iodine 131.

25

323 1 The new Part 35 is supposed to be a risk based rule, and 2 for that reason I applaud the increase in training hours, because I 3 believe that the therapeutic use of unsealed source radioactive 4 material is about as high a risk as you get in these rules.

5 However, I totally disagree with the idea and decision to maintain 6 the training and experience for oral I-131 to 80 total hours and 7 three supervised cases.

8 Of all the current unsealed source therapies, I-131 9 poses the greatest radiation risk to ancillary personnel and the 10 general public, and compared to other therapies, those involving 11 I-131 have proven to be the most likely to have a misadministration.

12 And when an I-131 misadministration occurs, it has the potential of 13 having a considerable radiation effect both on the patient and the 14 public.

15 It only takes about 30 micro curies of iodine to deliver 16 a 50 rad dose to the thyroid, and it exposes many other organs to 17 unnecessary radiation doses compared to the limited exposure of a 18 sealed source. And beyond that, it can cause unnecessary exposures 19 to the public from a variety of routes, both directly from exposure 20 to the patient and indirectly by exposure to contamination caused by 21 the patient.

22 For these reasons, the new Part G will not recommend 23 having lesser training requirements for those authorized users who 24 wish to use only oral I-131 for therapy. The committee will 25 recommend that they be required to have the same training and

324 1 experience as anyone else who wishes to use unsealed source therapy, 2 and that means 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.

3 Now, let's take a look at the training and experience 4 for technologists. One of the things I wanted to have included in 5 the revised Part 35 was a set of minimum training and experience 6 criteria for technologists. They're the ones who actually handle 7 the isotopes and dose the patients 99 percent of the time, yet 8 there's no minimum training and experience requirements in the 9 rules. Well, unfortunately, the NRC decided not to include any such 10 criteria in the new rule.

11 During the SR6 committee meeting that we had this past 12 February, we heard from the Society of Nuclear Medicine. They're 13 trying to push a bill through Congress that would essentially 14 require all states to adopt minimum standards for nuclear medicine 15 technologists. These standards, from what I can gather, would 16 essentially mean that the individual must be a certified NMT before 17 they can actually go in and do the work.

18 To begin with, I don't believe they got a chance to get 19 this through Congress, and if they do get it through Congress, it's 20 not going to stand up in the courts, in my opinion. Therefore, SR6 21 is going to try and come up with a set of minimum training and 22 experience criteria for nuclear medicine and therapy techs. These 23 requirements will only cover radiation safety topics because that's 24 our only area of purview.

25

325 1 We tabled this subject in February to see what comes of 2 SNM's push for this new law, but if nothing has happened soon, I 3 wanted to have something ready to go into the new rule. We've 4 already gotten minimum training and experience requirement 5 information from many of the states who currently require licensure 6 or registration of their technologists, and we plan to use that 7 information in drafting our rule text.

8 Now obviously, this text will not be as restrictive as 9 some of the current state requirements. But for those states who 10 don't have any current requirements, it's a good starting point.

11 Now, let's talk about one of my favorite rules to bash.

12 Anyone who was at the working group meetings -- and you can 13 definitely ask Cathy this -- says that I don't agree with this 14 reporting rule at all. The supposed reason for such a rule was to 15 keep licensees from having to run a pregnancy test on every woman of 16 childbearing age prior to even a diagnostic scan being performed.

17 Well, I've spoken with a few of my authorized users and medical 18 physicists in my state and they've told me that it would be very 19 rare that a diagnostic nuclear medicine study would result in a dose 20 to an embryo-fetus that would exceed 500 millirem.

21 All of my training has told me that the embryo-fetus is 22 the most radio-sensitive time in an individual's life and that the 23 infant is the second most radio-sensitive. And whatever the NRC 24 says, I see this as a de facto approval to allow embryo-fetuses and 25 nursing children to receive up to 50 times more exposure than the

326 1 rest of the general public and ten times more exposure than a person 2 would normally get from an individual who's been released as a 3 patient.

4 After a discussion among the SR6 committee members, it 5 was decided that the revised Part G will not include such a 6 reporting requirement. We will instead allow Part C exposure limits 7 and reporting requirements to take precedent.

8 Now, let's turn to the parallel rulemaking process. How 9 is it supposed to work and how has it worked with Part 35? Parallel 10 rulemaking is supposed to give the states early and substantive 11 involvement in the process of writing or rewriting a rule. This 12 involvement should include continuous discussion with an input from 13 the states, so as the rule is forming the states should be able to 14 lend their experience and expertise in trying to make this the best 15 possible rule.

16 Parallel rulemaking does not mean that the comparable 17 suggested state regulation will be completed at the same time as the 18 NRC's rule. But it should give the SR committee a head start on 19 writing the new SSR because the members should have been kept up to 20 date on the progress of the rule and should have been able to start 21 discussing ideas of what they want to do for a revision of their 22 SSR.

23 Now, how has the parallel rulemaking process worked 24 during this rewrite of Part 35? If you saw my poster presentation 25 at the Louisville meeting, you know that I think the process has

327 1 been pretty helpful. For the process to work its best though, the 2 states should be represented on the rule writing teams. The Part 5 3 working group included Marcia Howard from Ohio as well as myself, 4 and Tom Hill was representing the Agreement States on the steering 5 group. This seemed to work well, and my being on the SR6 committee 6 also helped a great deal.

7 Because of that, for any major rule revision or new rule 8 writing, I strongly urge the primary SR committee that's affected by 9 the change to have a member on the NRC working group, and the 10 Agreement States need to have representation on the steering group.

11 Having these state representatives on the working and 12 steering groups provided for a better line of communication to the 13 Agreement States. The representatives can relate specific areas of 14 concern about the draft rule to the Agreement States and then the 15 Agreement States' comments and concerns and suggestions about the 16 rule can be related in person to the working groups. It also gave 17 me the ability to give regular updates to my SR committee members, 18 and that allowed them to understand the direction the NRC rule was 19 taking and start formulating ideas for the SSR text.

20 As I mentioned earlier, our committee met in February of 21 this year, and I think we were all pleasantly surprised at the 22 amount of work we got done in the amount of time that we had. I 23 attribute much of this to the members being informed of the NRC 24 drafts so we didn't have to waste time bringing everyone up to date.

25

328 1 In closing, I don't think that the new Part 35 is a 2 perfect rule. Most of us will disagree with some parts of it. I do 3 believe that the revised Part 35 is now a more performance-based 4 rule that sets the minimum standards and lets the licensee decide 5 how they will meet those standards. But to a lesser extent, it's a 6 more risk based rule that lessens the regulations on lower risk uses 7 while maintaining higher radiation safety restrictions for the 8 higher risk uses.

9 Part G will parallel Part 35 for the most part, but in 10 the areas I've discussed today, it will be divergent. SR6 is in the 11 process of compiling the first draft of the Part G revision right 12 now. I hope that we'll have the draft out soon for peer review, and 13 it's my intention to include all of the state program directors in 14 the peer group. And that means that I expect each and every one of 15 you to give me comments. Okay? I don't care if it's con or pro.

16 Preferably pro, but whichever way, I need comments.

17 I want to thank you for allowing me to talk to you 18 today.

19 MR. CAMERON: Okay. Thank you very much, David. And 20 regardless of your position on the issues, that was a very useful 21 analytical breakdown for everybody to try to help understand this.

22 We're going to take a break until 10:30 because I know 23 that you see people coming in with coffee. And so go and take a 24 break and then we're going to come back and Cathy will talk to us.

25 [Recess.]

329 1 MR. CAMERON: You heard David's analysis of what's going 2 on with Part 35. Cathy Haney from the NRC has been involved in this 3 longer than she probably has wanted to be -- is going to tell us 4 where we are on this.

5 And, Cathy, I don't know if you're going to spend much 6 time on it, but I think the Agreement States are probably going to 7 be curious about what this means -- the rule might mean for them in 8 terms of adequacy and compatibility too, so you may anticipate some 9 questions on that. But why don't you go ahead?

10 MS. HANEY: Thanks, Chip. Okay. Good morning. What 11 I'd like to cover today is just an update on the rulemaking. Since 12 we did a presentation at last year's Agreement States meeting, I 13 want to focus on what's changed since last year rather than go into 14 some of the details on the rule, but if you'd like me to go into 15 some of the more detailed issues I can do that.

16 I'll give you a little information about where we are 17 with the Commission right now as far as where the SECY paper and the 18 draft final rule language is and what we needed to provide to them.

19 I'll also tell you some about the major areas for consideration.

20 Some of this is a little bit redundant with what Dave has already 21 spoken about, so I'll be able to breeze through that a little bit 22 quicker and tell you our projected schedule and then the 23 implementation issues that we see associated with the rule.

24 As far as an update on the rulemaking activity since we 25 last spoke, in December of '98 the comment period closed on the

330 1 rule. As a result of the recommendations from the Organization of 2 Agreement States as well as some of the public comments that we 3 received, we went back to the Commission, said we'd like to extend 4 the comment period for an extra 30 days. Would that be agreeable?

5 They did approve it, so the comment period was extended and it went 6 into December.

7 In February of 1999, we met with some representatives 8 from the training organizations -- the board, to focus in a little 9 bit -- really to focus on implementation issues associated with what 10 we were proposing in the training and experience areas. We also had 11 some meetings with the ACMUI, which is the Advisory Committee on 12 Medical Uses of Isotopes, and then in the May-July time frame we put 13 a package into Office of Review and Concurrence. Just a couple of 14 weeks ago, in August, the paper did go to the Commission, and the 15 next milestone that we're looking forward to is an October 21 16 Commission briefing where we'll discuss with the Commission directly 17 some of the specifics of the rule language.

18 As I said, we did forward the draft final rule language 19 to the Commission under SECY-99-201. It was August 3. You do have 20 a copy. The next view graph will tell you where it's located on the 21 NRC website if you'd like to view the document. It's about 4-1/2 22 inches thick, so I think we're close to 1,000 pages. So I didn't 23 bring copies to hand out today to everyone because I thought you're 24 not going to take it back with you anyway.

25

331 1 Basically what that does is it gives the Commission the 2 draft final rule language. It's the entire -- and it's presented 3 under a draft Federal Register notice, but we didn't put all the 4 boilerplate into the Federal Register notice. There's a section 5 where we go through the public comments on the rule and what our 6 responses would be to the public comments. There's also a 7 comparison of the current rule to the draft final rule.

8 This is something that we typically do not need to put 9 into a Federal Register notice, but we were trying to be user 10 friendly, and if I was a physicist out on the field I wouldn't 11 really care what the difference was between the proposed and the 12 final rule. I would really want to know what's different from what 13 I'm doing today as to what I have to do when the rule goes into 14 effect. So that's why that section has been put in there.

15 We asked the Commission approval to go ahead with 16 finalizing the package and then we also asked the Commission to give 17 us permission to go ahead with beginning the notification process to 18 telling specialty boards that we would start to recognize them. And 19 I'm just going to let that topic sit there for right now, because 20 I'll get into that a little bit more in depth when I get to the 21 discussion on the training and experience.

22 As I said, you have copies of my view graphs. These are 23 the locations for the website for the rulemaking if you do want to 24 take a more detailed look at it.

25

332 1 The major areas for consideration today are the topics 2 I'd like to discuss with you. This is really where the big changes 3 are -- where changes were made since we last spoke.

4 The need for a formal risk assessment -- if you remember 5 last year this group discussed whether NRC should go ahead with a 6 formal risk assessment or not. We went back -- we considered 7 whether that was needed or not and we decided that, following the 8 idea that we would do a risk-informed rule, we felt that we had 9 enough information and that we could go forward with the information 10 that we had. That information came from many places.

11 Someone earlier mentioned NMED. We have used NMED to 12 look at different types of incidents. We used previous reports that 13 have been done in the medical area as well as our experience in 14 inspection and enforcement. So we have not gone forward with a 15 formal risk assessment, but we have -- do believe this rule is 16 definitely a risk-informed rule.

17 As Dave mentioned earlier, the review of procedures 18 prior to license renewal -- we are not going to require licensees to 19 submit detailed procedures to us in support of a license renewal or 20 a license issuance in the medical arena once 35 goes into effect.

21 For example, in a diagnostic nuclear medicine -- let's say a 22 stand-alone clinic. That's an easy one -- what the potential 23 licensee will tell us: name, address, facility diagram, what 24 equipment they're going to have, the training and experience of 25 their authorized user, and their radiation safety officer. And that

333 1 would be all that would come into us in support of the license 2 application.

3 However, if you were setting up like a remote after 4 loader clinic or one of the therapy modalities, then we would be 5 looking for some procedures. Those procedures are indicated in the 6 regulations, but this is the balance between low risk and high risk.

7 In the high risk area, if we felt that it would be needed we would 8 need to see the procedures.

9 Use of third party accreditation programs was another 10 issue that came up last year. It was really brought to our 11 attention more by the professional organizations, and this was 12 something like the American College of Radiology, where they do --

13 they're out accrediting programs right now and they're saying that 14 if we accredit a program would it be possible for NRC just to step 15 off and not do an inspection then?

16 They came in with that. We discussed it at a lot of the 17 public meetings. The draft federal notice basically says, We heard 18 you. This is an idea maybe worth pursuing but we'll do it separate 19 from this rulemaking. Based on conversations I've had with the 20 American College of Radiology, I suspect this issue is going to 21 resurface in the next couple of months again, so we will probably be 22 discussing that with you next year.

23 Okay. The next five areas I have specific view graphs 24 on, so I'm just going to go ahead and move to those now. The first 25 one is training and experience. This obviously was probably the

334 1 biggest issue that we dealt with over the last two years. These are 2 the motherhood sort of statements that you see here. Our 3 requirements would be risk-informed. We would focus on radiation 4 safety. That was number one going into all of our meetings.

5 The next thing that we came out with is that individuals 6 should complete classroom and laboratory training, supervised work 7 experience, and in some cases, clinical cases. In the clinical 8 cases, this is where you're seeing your use of unsealed byproduct 9 material like the iodines or your 35.300 uses is where we actually 10 specified some cases very similar to what the current rule does. We 11 did not break down the hour requirements.

12 In the current rule, we have so many hours of didactic 13 training, then we have so many hours of clinical, then we have so 14 many hours of practical. And that breakdown has worked very fine up 15 to now, but as a result of the last 2-1/2 years, we felt that we 16 really would be okay to just go ahead and specify, for example, 700 17 hours1.967593e-4 days <br />0.00472 hours <br />2.810847e-5 weeks <br />6.4685e-6 months <br /> of training, and specify what we want the individuals to know 18 when they come out of that training. This is very similar to what's 19 being done right now for the nuclear pharmacists. So we're really 20 relying on our experience with nuclear pharmacists to say, If it's 21 worked for pharmacists, why shouldn't it also work for authorized 22 users for the physicians?

23 This has resulted in a lot of questions coming back to 24 us from the different members of the public that have already 25 seen -- have downloaded the rule and said, Well, you said 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.

335 1 Do you still want 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of didactic and 500 in the clinic, or is 2 it 50 and 600? And I said what we're saying is that's up to you.

3 You guys decide what you need. The information of what you need to 4 know is in the rule, and whatever hours it takes, whatever that 5 breakdown is, fine. You go with it. Otherwise, we're not going to 6 tell you.

7 And at the same time, we've also said there's no hidden 8 agenda. It's not like we have this hidden document back in the 9 office that says if you don't have ten hours of this and 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of 10 that, we're not going to approve or recognize your program. So this 11 is really a major change in thinking for how we will be handling the 12 training and experience areas.

13 We did not go forward with the requirement for an 14 examination in the rule. As a result of all the comments we 15 received during the public comment period, the comments we received 16 from this organization and the comments we received during the 17 February meeting with the specialty boards, we realized that this 18 was probably not where we wanted to be for various reasons. Again, 19 for the sake of time I won't go into the reasons but they are 20 specified in the Federal Register notice.

21 At one time we were also thinking about approving 22 training programs in lieu of the exam. Again, as a result of 23 significant discussions, we realized we didn't want to be there 24 either. So looking at -- we're not going to have an exam, we're not 25 going to be approving training programs, what assurance does NRC

336 1 need to say that someone is properly trained to handle material 2 safely? So it really boiled down to they needed to have a certain 3 number of hours. We needed to specify what those hours were. And 4 also we would revise the precept or statement.

5 So the preceptor statement is now not just the preceptor 6 saying, Yes, this person got the training. The preceptor statement 7 now is the preceptor saying, The individual received the training 8 and in my opinion the individual is competent to function as an 9 authorized user, as a radiation safety officer, as a medical 10 physicist. So this is a significant increase in burden on the 11 preceptor.

12 Again, I believe people are starting to realize this 13 based on the number of calls that I'm getting, because they're 14 saying, Cathy, is this what you really mean? And I'm saying, Yes.

15 There will only be one preceptor. It's not like you're going to 16 have a preceptor for the classroom training and a preceptor for the 17 practical training. There's only going to be one person at the end 18 that say, Yes. In my opinion, this person is competent to function 19 as an authorized user or whatever.

20 Now, I don't have copies -- I mean on Powerpoint 21 presentation of the actual hours, but those of you that do have my 22 handout, if you look at the last two pages there is the actual 23 detailed breakdown of what the training and experience requirements 24 would be. And what you're really looking at is the alternative 25 pathway for the training and experience. This would be if someone

337 1 was not board certified by some -- by a board that had been 2 recognized by NRC.

3 Again, the big difference here, as Dave pointed out, is 4 that we have decreased the hours for 35.290. These would be the 5 people that would be using unsealed material for imaging and 6 localization, where a written directive was not required. Currently 7 NRC requirements are 1,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />, so we've gone from 1,200 to 700.

8 For those of you that do remember the proposed rule, we have upped 9 that. The proposed rule went out at 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> but based on comments 10 that said that you need to be in a clinical environment to learn how 11 to handle material safely, we felt we should increase those hours.

12 We increased the hours in 35.390, which is your unsealed 13 material for therapeutic uses. We did leave the use of iodine, the 14 training and experience requirements, pretty much the same as what 15 they are right now in the current rule. There are some little, 16 minor changes, but for the significance here -- the hour amounts are 17 the same. We left them there based on our experience with use of 18 iodines by the endocrinologists. We don't have the record to show 19 that there has been a problem with the uses. Considering that, we 20 felt that we would propose that the requirements stay where they are 21 right now.

22 And as I said, you can thumb through these: the next 23 page where it goes into the radiation safety officer and some of the 24 therapy modalities. I would point out one thing though, on the view 25 graph where it talks about the training for the radiation safety

338 1 officer, it does not list that if the person is an authorized user, 2 they can also be the radiation safety officer. That's one thing 3 that's omitted from this graph.

4 Let me take a -- not graph, chart. Let me take a second 5 and talk about the board certification process. Under NRC rules, if 6 an individual -- an authorized user or physician presents them self 7 to the hospital and they're certified by one of the boards listed in 8 the rule, all the hospital needs to do is notify NRC that this 9 person is going to be an authorized user. They don't have to do an 10 amendment. We like that philosophy basically and we wanted to 11 continue it, but we also wanted to get away from listing the boards 12 in the rule, because every time a board would change, we would need 13 to revise the rule. And this could become labor-intensive, 14 resource-intensive.

15 So we have a statement in the rule now that says if an 16 individual is certified by a board, a specialty board that's been 17 recognized by NRC or an Agreement State, then you can kick into that 18 notification process rather than the amendment process. And what 19 that would allow us to do is to recognize boards, put it out on our 20 website, get it out to the public that this is a recognized board, 21 and then the process works real nice after that. But people -- the 22 natural question is, What does it take to get recognized by NRC?

23 And what we are looking for right now is that the board 24 would send NRC a letter saying that in order to -- basically it's 25 going to say,

Dear NRC,

in order to sit for our board to become

339 1 certified, the individual would need to complete all the training 2 required in the alternative pathway. And that will include that 3 precept or statement. Once they provide that to us, then we would 4 recognize the board, and we would -- process works fine from there.

5 Because we want the rule to become effective as soon as 6 possible, we would like to start this recognition process early 7 before the rule hits the street, so that on Day one when the rule 8 goes into effect, we already have a list of recognized boards. But 9 in order to do that, we need to go ahead and seek Commission 10 approval to begin that recognition process. So that is one of the 11 items with the implementation issues that I mentioned earlier, and 12 references back to that previous slide.

13 Medical event reporting -- again, I have a detailed 14 slide in the package that you have that describes exactly where the 15 limits are. I'm not going to go into that level of detail for this 16 presentation. But basically, there are no significant changes. We 17 did try to address two things in the rulemaking. One was patient 18 intervention and the other was wrong treatment site.

19 To address the wrong treatment site issue, we've put a 20 dose threshold in the rule, so we don't want to hear about anything 21 it hits the 5 rem whole body or the 50 rem organ dose. So if it's 22 something down in the lower levels, you don't need to tell us about 23 it. In order to address patient intervention, we have made the 24 statement that we do not want to hear about any cases that involve 25

340 1 patient intervention unless there is unintended permanent functional 2 damage to an organ or physiological system.

3 Those words come from our abnormal occurrence policy, 4 and this is really to -- at this point when something would happen, 5 whether or not it was the result of patient intervention, we need to 6 hear about it so that we can make others aware of it and then also 7 to meet our requirement to report to Congress.

8 And then also there was a minor change in what the 9 licensee needs to do. They no longer need to make the patient aware 10 that they could get a copy of the NRC report. We did -- they still 11 need to tell the patient about it and fill them in on the details, 12 but what we heard from the physician community was that report was 13 scaring the patient; the fact that there was a report filed with 14 NRC. So we have deleted that, but we feel the patient is still 15 going to get the needed information.

16 Dave touched on this particular topic in his discussion.

17 We have included a reporting requirement in the case of the 18 embryo-fetus or the nursing child. Again, as Dave said and as I've 19 said numerous times, from our standpoint this is a reporting 20 threshold, not a dose limit. And that is stated very clearly in the 21 Federal Register notice on the rule. It helps us -- we have a 22 reporting requirement under the AO criteria that we need to go to 23 Congress with.

24 We believe that this rule is recognizing that the 25 standard of care, standard of practice, is to test for pregnancy

341 1 when needed, so we did not need to put a pregnancy testing 2 requirement into the rule. And as a result of this reporting -- it 3 may result to reevaluation of this particular rule but at this 4 point, we believe only a reporting requirement is needed.

5 Radiation safety committee -- again, based on -- the 6 comments that we got were really divided. If you are a health 7 physicist, radiation safety officer, the worst thing we could have 8 ever done was to delete the requirement for a radiation safety 9 committee. If you were a hospital administrator or an authorized 10 user, the proposed rule was great. This wasn't one of those things 11 that there were any gray zones on the public comments. It was very 12 black and white.

13 We went back and considered risk. And really, based on 14 risk, we believed that if the hospital licensee was dealing with the 15 high risk modalities, that they should have a radiation safety 16 committee. If all they had was your diagnostic nuclear medicine 17 department, one room in the basement and that's it, they don't need 18 a committee. But if you're dealing with remote afterloaders, the 19 gamma stereotactic radio-surgery units, you did need a radiation 20 safety committee.

21 And the rule -- we've dropped a lot of the prescriptive 22 requirements about who has to write the minutes and how frequently 23 they need to be in, but we did maintain the same membership --

24 specifying the membership.

25

342 1 In the case of a temporary radiation safety officer, I 2 want to go on record as saying the Part 35 group recognizes that 3 RSOs drop dead. And in that case, you can't get a license amendment 4 in quick enough and therefore we made provision for a temporary 5 radiation safety officer. In this case, a licensee can have someone 6 operating as a temporary RSO for up to 60 days a year.

7 We have had to recognize that there could be more than 8 one temporary radiation safety officer at the facility because for 9 example, if Dave was only qualified for -- was an authorized user 10 for diagnostic nuclear medicine, say 35.200 uses, but yet the 11 facility had 35.600, he could not qualify as the RSO for the 35.600 12 uses, the therapy uses. So therefore, you would need two temporary 13 RSOs. This isn't the best way to do it, but considering real world 14 what happens, we believe that this is the best way to have gone.

15 Written directives -- we have deleted the requirement 16 for the quality management program and for NRC to review it. As I 17 said earlier, we are not going to be reviewing procedures in support 18 of the license application. This is one of the procedures we will 19 not be reviewing. 35.40 and 41 contain the regulatory requirements.

20 You still do need a written directive and you still need written 21 procedures for administrations requiring written directives to 22 provide high confidence the patient identity is known and that the 23 administration is in accordance with a written directive.

24 25

343 1 We believe this gives the licensees a lot more 2 flexibility in how they're setting up their program and their 3 department.

4 Now, as far as where do we go from here -- as I said in 5 October we have a commission briefing on the draft final rule.

6 We're guessing that it's going to take the Commission about four 7 weeks to get a paper -- the staff requirements memorandum out to us.

8 So that will be about November. I'm also being optimistic that 9 they're going to say, It's a pretty good job. You only need to 10 change maybe these five or ten things as compared to, You need to 11 change these 200 things in the rule. But hopefully they'll say you 12 got the right gist. It's going the right way.

13 And then from that time, we'll have three months to 14 complete the entire rulemaking package, which puts us into the 15 February 2000 time frame. We will need to go to OMB to get approval 16 for some of the records. OMB has up to 90 days to give us that 17 approval. Now we're into the April time frame. Say give us another 18 month to get it published, which is now May, and it has a six month 19 effective date in it. So realistically, we're looking at December 20 2000, maybe January 2001 for the rule going into effect. But again, 21 that all assumes that the draft final rule is pretty much where the 22 Commission intended it to be.

23 As far as implementation issues, I've touched on a 24 couple of these. One is the recognition of the medical specialty 25 boards, which hopefully we'll get started on that as soon as the

344 1 Commission gives us the guidance on the draft final rule. We have 2 the guidance document, which is one of the new reg 1556 documents to 3 finish there, and we're working on that right now.

4 Also, we see that we're going to have to go through some 5 training for our license reviewers and our inspectors, because this 6 is definitely more a performance-based approach toward rulemaking 7 and we want to follow that into the inspection arena also. So we 8 would expect some time next year going out to all our regional 9 offices and doing training sessions with all the staff that would be 10 working in touch by Part 35.

11 And I think -- and the next two slides are just the 12 backup, so I think I'll turn it back to Chip.

13 MR. CAMERON: Thank you very much, Cathy.

14 As all of you know, Cathy and her team were in Los 15 Angeles two years ago when this effort first kicked off, and in New 16 Hampshire last year, and she's described where the rule is today and 17 what the schedule is. And I would go out to all of you to see what 18 remaining concerns are there in the Agreement State community based 19 on what you heard, and obviously we heard about the CRCPD process 20 and there may be questions about what's the relationship between 21 that and where the Commission is going on this.

22 Ken, are you wanting to start off?

23 MR. WANGLER: Ken Wangler from North Dakota. I guess my 24 only question is on scheduling.

25

345 1 If you -- let's say that this thing becomes final or 2 implementation goes into effect in December of next year, is 3 there -- then there's a three year allowance for the states to adopt 4 the rule, and how is that double standard going to play out when you 5 have doctors say crossing lines between NRC jurisdiction and into 6 states? What are your thoughts on that?

7 MS. HANEY: The states do have the three years to 8 implement the rule. The training and experience requirements in the 9 rule have a C designation, and this has been a big discussion with 10 organizations that are doing training, not just for physicians but 11 also for authorized users, such that they're going to have a problem 12 with NRC -- who do you train to NRC requirements or state 13 requirements?

14 And we've acknowledged that that is an issue but given 15 the fact that we can't dictate to the state -- we can't tell you 16 this is the way it's going to be, nor can you come back to us and 17 say this is the -- I think we have to recognize that there will be a 18 discrepancy there.

19 MR. WANGLER: What about -- wasn't it on Part 20 where 20 the NRC delayed implementation for the period of time that it took 21 the states to adopt? Which rule was that? Wasn't that Part 20, 22 when all the changes came out for Part 20?

23 MS. HANEY: Yes. Well, with Part 20 the implementation 24 period was a lot longer and I guess we haven't considered that, to 25 be honest with you. It's something that -- it's worth considering

346 1 and maybe doing, but that's the first time I've heard that 2 suggestion.

3 MR. WANGLER: Okay. Well, that would be one of my 4 thoughts, that the NRC consider a delayed implementation to allow 5 everybody to come on board at the same time. I don't know.

6 MS. HANEY: Okay.

7 MR. CAMERON: And, Cathy, I might ask you one question, 8 a process question in terms of comments that the Agreement States 9 are raising at this meeting relative to the Commission briefing.

10 Will there be any documentation of Agreement State concerns for 11 the -- in any way for the Commission to have to consider at that 12 briefing?

13 MS. HANEY: Yes. I think there are two. One in the 14 Commission paper, the SECY-99-201. There is an attachment there 15 that lists where the SR6 committee differs from the Part 35, and it 16 pretty much -- I think it hits all the topics that Dave said. There 17 might be one or two others. It's very -- it really is where the 18 states differ, so that they'll have that for the Commission 19 briefing.

20 The other place that they'll hear about it is that in 21 October, we anticipate staff will brief and also the advisory 22 committee will brief the Commission at the same time. And Ruth 23 McBurney is on the advisory committee representing the state 24 interests, so I think if it doesn't come up as -- if these comments 25 don't come up as part of staff's presentation, they definitely can

347 1 come up during the ACMUI presentation as part of the state's 2 concerns.

3 So they will make it to the Commission.

4 MR. CAMERON: So if the states are expressing concerns 5 today or if they have remaining concerns, they should try to factor 6 that to Ruth --

7 MS. HANEY: Yes. Or to Dave or to me.

8 MR. CAMERON: -- and to David in some way?

9 MS. HANEY: Right.

10 MR. CAMERON: Okay.

11 Pearce, do you have a comment?

12 MR. O'KELLEY: Yes. I think so.

13 You stated that ACR had approached you about doing away 14 with inspections on facilities that are ACR accredited. I strongly 15 urge you do not consider doing that.

16 Those of us who have the pleasure of intimately working 17 with ACR in the federal mammography program are very much aware that 18 ACR accreditation does not ensure quality. It does not ensure 19 compliance. And you're looking at an organization that is trying to 20 be able to add an additional marketing tool to their accreditation 21 program, and I think that's their major reason for wanting this.

22 We've seen major problems in facilities that have been accredited by 23 ACR, and the accreditation does not guarantee adequate and safe 24 performance by the facility.

25

348 1 And many times, the accreditation process goes through 2 and that's the end of ACR's involvement, and a lot of that's a paper 3 review. Things in that facility change. The ACR may or may not be 4 aware of those changes. The people that were there originally may 5 or may not be there. I just think it's not sound practice to even 6 consider that.

7 On another issue, to be overly redundant again, I still 8 don't agree with the 500 MR release criteria. We're seeing a lot of 9 problems under the current release criterias in our state with --

10 and we're spending a lot of resources agency wide going and dealing 11 with alarms being set off at medical waste incinerators and so 12 forth, and I urge you again to look at the impact on other areas 13 with this ruling.

14 MR. CAMERON: Okay. Thank you, Pearce.

15 Don Cool just reminded me relative to Agreement State 16 input to the Commission on the draft final rule that the 17 Organization of Agreement States I guess has a briefing of the 18 Commission the same week that the Part 35 briefing is occurring, and 19 to the extent that there are some uniform state concerns, I suppose 20 that could be incorporated into the OAS briefing.

21 Bill?

22 MR. DUNDULIS: Cathy, two parts, both kind of related.

23 On the specialty boards, for lack of a better word, are all of the 24 current roster that's actually coded in the regulations going to be 25 grandfathered or will they have to reapply? And then secondly --

349 1 and this is a concern for us primarily in the therapy area -- how 2 are you going to address foreign boards?

3 It's very common I've found, at least in the east, that 4 a lot of your oncologists and even your therapy physicists will 5 British or Canadian certification. And some of them are included 6 now, but I know there's a couple that we recognize the therapy that 7 are Canadian that are included on your list but that we've done our 8 homework and we know their equivalent. So how are you going to 9 handle the issue of foreign boards, because it's going to be a real 10 issue for therapy?

11 MS. HANEY: Well, I guess first of all, the boards that 12 are currently listed in our rule will have to reapply. We did not 13 grandfather anyone. Secondly, as far as the foreign boards go, they 14 can go through the same process that the other boards do. All 15 they'll need to do is submit some type of certification to either us 16 or to an Agreement State saying that their requirements would -- in 17 order to sit for their board they need to have the required 18 training.

19 If we get Commission approval to go ahead and start this 20 process early, we have a letter that we're going to mail out to all 21 the board that are currently recognized, which would catch the 22 Canadian ones. I think they're the only foreign ones that are 23 listed right now.

24 MR. DUNDULIS: British.

25

350 1 MS. HANEY: Oh, okay. So we would have letters going 2 out to them at least alerting them to the fact that we are changing 3 our regulations and this is the new process if they want to stay 4 recognized. If there are any other boards that anyone here knows 5 about that you want to give us a heads up to, and if you've 6 recognized some that aren't in the rule, if you would like let me 7 know who they are with addresses, we can get the -- also send them 8 this letter to give them early notification.

9 MR. CAMERON: Okay, Jake?

10 MR. JACOBI: I think I'm like Pearce and somewhere in 11 here I have a question, and I'll try and frame it. And it relates 12 to the relationships between Part 35 and Part 20.

13 Now, at one time, if the wrong chemical form of a drug 14 or the wrong isotope or the wrong patients were injected, we at one 15 time required reports, but now we have medical events and we have 16 triggers for all of this. However, in Part 20, all of our licensees 17 are required to document an annual ALARA review. Now, I think we 18 would all agree that if you give the wrong patient an injection of 19 an isotope, it is not as low as reasonably achievable. If you give 20 the wrong drug to the right patient and have to redo an exam, it is 21 not as low as reasonably achievable.

22 So I guess my question in there is, while they no longer 23 have to report all these diagnostic misadministrations under Part 24 35, is it possible to have an annual ALARA review if you do not 25

351 1 track how many misadministrations under the old definition that you 2 have given?

3 MS. HANEY: I guess -- let me try to answer the 4 question. From the standpoint of 35, with the -- 35 is really meant 5 to be the reporting requirements; at what point NRC needs to know 6 about it. So that would be the one point I would like to make.

7 In the case of the ALARA reviews, the licensees are 8 still required to do the ALARA review. Just because the ALARA 9 requirement has been deleted from Part 20 -- I mean from Part 35, 10 they still have to comply with Part 20. So under 20, I guess what 11 you're getting at is, we've given the licensees flexibility on that 12 ALARA program -- what they look at. What you've said is very true.

13 If they give a radio-pharmaceutical to the wrong person, that is not 14 necessarily ALARA.

15 And i would say what we need to do is maybe look at some 16 of -- in our guidance documents where we talk about the ALARA 17 program review that they need to do under Part 20, we might want 18 to -- there, we could bullet some things that they might want to 19 consider. At this point, I don't think we want to go into a 20 regulatory forum and say that when they do the ALARA requirement 21 they need to look at these.

22 MR. CAMERON: Okay, thank you. Ed?

23 MR. BAILEY: I'm probably going to show my ignorance, 24 but under the embryo-fetus-nursing child limit, your requiring would 25 require a report if it exceeded 5 rem. But wouldn't a minor have to

352 1 be -- exposure have to be reported to you at a much lower level if 2 they just happened to be sitting outside a teletherapy room?

3 MS. HANEY: Yes. So --

4 MR. BAILEY: So why is there --

5 MS. HANEY: Why is there a difference?

6 MR. BAILEY: Yes. We're all having these problems with 7 different limits and trying to remember, and although some of us 8 have excellent memories, they're awfully short at times. And so 9 we -- why can't we harmonize this with just the regular reporting 10 requirement for a minor person?

11 MS. HANEY: There are a couple of reasons we're not 12 going there right now. One of the reasons is that we do want this 13 to be a reporting level, not a dose limit. And 20 has got your dose 14 limits in it, 35 -- the requirement for embryo-fetus is just the 15 reporting.

16 We're recognizing that these patients are under medical 17 care. And one thing I did not say earlier was that these are only 18 the unintended. If a physician knowingly doses an embryo-fetus or 19 for some reason tells the mother to continue breast feeding and a 20 child would get a dose in excess of 500, that's not covered under 21 this reporting threshold. That's not good medical -- but we're not 22 going there.

23 The proposed rule went out at 500. A lot of the 24 comments that we got was that that would significantly affect 25 medical care negatively. The documentation that we have differs

353 1 from what Dave indicated, that there are a -- I don't want to say 2 significant, but let me say one step down from significant number of 3 diagnostic procedures that have the potential to trip the 500. If 4 that was the case, we really are instituting a de facto pregnancy 5 rule and at this point, we don't want to go there.

6 This is almost a first step of trying to gather 7 information on is this a big problem? Is it not a big problem? If 8 you talk to one person, they're going to say there are a lot of 9 people -- children that are getting doses as a result of the medical 10 treatments. But then you look and read articles in the health 11 physics society and they're saying, No, they're not. If you read 12 ones in the physicians' journals, you're seeing not.

13 So we're trying to take almost a gradual approach.

14 Let's see what the problem is at this level. We do have the 15 statutory requirement to Congress, but at the same time we want 16 to -- it's not just because we have to report to Congress. We want 17 to know because of health and safety issuances. Yes, we recognize 18 there is a difference with Part 20, but at this point we're going to 19 start with the 5 rem limit and call it reporting rather than a dose.

20 But to go back to what you said, Yes. If you had a 21 minor sitting outside a therapy department and if they got 501, yes, 22 they would have to notify us. But we recognize that difference 23 there.

24 MR. BAILEY: Okay. One other comment, if I may. I 25 don't know whether I understand the great concern and so forth with

354 1 gamma stereotactic units. They're treated like they're some fancy, 2 highly intricate machine type thing, and therefore they have all 3 kind of failure modes and great potential for harm if they fail.

4 They're treated with sort of an awe. And I was looking at the 5 training requirements and so forth. I don't understand this great 6 concern about those units, and maybe someone could enlighten me on 7 that.

8 And the other issue is over under the authorized users.

9 Most of the ones that I am familiar with have a team approach to it, 10 which includes generally a surgeon, a real life, honest to God, use 11 a knife surgeon who is a primary player in outlining what's going to 12 be zapped, and not the radiologist. So I'm concerned about whether 13 or not you're going to have some different training requirements for 14 them, or are you even going to address it?

15 In my limited experience with them, the surgeon is the 16 one that said, Go with this. It was not the radiologist. So 17 that -- and you have a committee for those facilities and many of 18 those are being put in stand-alone facilities where the only people 19 that are really there are the surgeon and the oncologist and a tech 20 and a medical physicist who work together every day, so you make 21 them formally have a committee of the same four people.

22 MR. WALTER: Well, remember, if they're just doing Gamma 23 Knife, they don't have to have a committee. Two or more of them --

24 and you're right. They do work as a team but essentially what 25 happens is the surgeon outlines, this is the area that I want

355 1 affected. It's the oncologist who decides what does needs to go to 2 each of those -- in that area and then takes that to the physicist 3 for them to determine how that's going to be set up to get the right 4 dose.

5 So, yes. They outline the area they want affected and 6 then the oncologist decides how they're going to affect that area.

7 So you're right but at the same time, it is a team effort. But the 8 surgeon doesn't say, I need 300 rads here. They don't do that.

9 They just say, This is what needs to be obliterated.

10 MR. BAILEY: All right.

11 MR. CAMERON: Cathy, do you want to follow up on that?

12 MS. HANEY: Yes. From the standpoint of the rule, when 13 this rule goes into effect it is different than how we're currently 14 licensing authorized users. NRC is looking at the team approach.

15 This rule would recognize someone with three years' experience as 16 far as the authorized user for use of the Gamma Knife.

17 We were trying to focus in on radiation safety and the 18 handling of the material, and a surgeon -- if they had that 19 experience could go ahead and -- we would recognize them as the 20 authorized user. But based on what we heard from public comment, 21 what we heard from the different meetings that we had, that we 22 should just still stick with the three years and authorize the one 23 person.

24 This is also going to step really into if -- I'll sit 25 over there. You come sit here. It's the next step of using the

356 1 materials in the cardiology treatment with the therapies that we may 2 be seeing, is what are the training requirements for that type of 3 individual? And that's something that I think will be the -- when 4 we finish this rulemaking we'll start on looking at the training and 5 experience requirements.

6 Is the individual going to be required to have the same 7 type of training as someone either using material for -- you say you 8 equate it to remote after loaders, or do you want to equate it to 9 manual? Either way, you're up into the three years. Do you still 10 need the quote, radiation oncologist or could just a cardiologist 11 become qualified to use that material?

12 MR. BAILEY: My personal preference -- if somebody's 13 going to be putting a stint in me, I don't want it being an 14 oncologist. I want the -- and when we talk about those individual 15 stints and balloons and all that other stuff, the individual 16 radiation dose from those is insignificant, and there ought to be --

17 I would encourage you to look at them in the same way you looked at 18 nuclear pacemakers and treat them in that manner as opposed to 19 having -- even implying that you need all this radiation safety 20 training for the most part, particularly on the solid stints.

21 MR. CAMERON: Okay. Thank you. We're going to go to 22 one final comment from the table, and then we have a brief statement 23 from a guest in the audience.

24 Aubrey?

25

357 1 MR. GODWIN: Cathy, I apparently had a moment here when 2 you started talking about these embryo doses and unintentional 3 exposures. The logic of it escaped me because as I understood you 4 to say, the reason you went with the 5 rem was because there's 5 concern about the diagnostic doses. Several of the diagnostic 6 procedures exceeded the 500 millirem. If it's prescribed, I believe 7 that's an intentional, not an unintentional exposure unless there is 8 concern on the part of the medical community that they're not asking 9 the people -- they would have to start asking, I guess, I should 10 phrase it -- the people who are going to get over 500 millirem if 11 they're pregnant or not.

12 The logic of why you're going to 5 rem for unintentional 13 exposure just doesn't track very well, since the regulation has it 14 at 500 millirem. And if this happened to be anything other than a 15 medical -- a nuclear medicine procedure, they'd have to write all 16 sorts of reports about it on unintentional exposure just because it 17 exceeded the 500 millirem. And now you're going to just suddenly 18 say, Well, if it's unintentional, we're going to skip Part 20 and 19 not do any report writing on it 20 because -- for an embryo.

21 And I don't really see, are you purposely trying to 22 write an exception to Part 20 with this regulation and is it said 23 that well in the regulation itself, because I think there's a chance 24 for confusion on the part of people that interpret it. And I can 25 harken to the lawyers coming back and asking me, Okay. You didn't

358 1 have to report it in this regulation, but this other regulation says 2 you need to report these exposures.

3 So if you could sort of clarify the logic in there, I 4 would certainly appreciate it.

5 MS. HANEY: Well, let me try. I'd like to say that the 6 rule is a lot clearer than what I said verbally.

7 What -- we're seeing this as a more specific requirement 8 than the Part 20 requirement, so in our case, to answer your 9 question, if there was an incident a licensee would look to, does it 10 need to be reported under Part 35? And if it did not, then we 11 wouldn't double dip and go back and say, Ha, ha. You should have 12 reported it under Part 20 and now you're in trouble. So we would 13 say meet the Part 35 requirement in this case.

14 The 5 rem limit is looking at, how much does this rule 15 impact medical practice? I mentioned the diagnostic, not that we're 16 trying to catch those diagnostic cases unless the threshold is 17 higher, but because of the impact on the practice of medicine if we 18 were to have the limit at 500. And the impact that we see -- again, 19 this is where the information I have differs from what Dave has --

20 we have been given information that there would be a large number of 21 procedures that would require pregnancy testing now if the limit 22 were at 500 millirem. And that goes down even into the diagnostic 23 level.

24 And if that's the case, then we're looking at delayed 25 treatments to patients because we have to wait for the results of

359 1 the pregnancy test. You're also seeing problems where -- with the 2 preferred providers that they can't -- the hospital that they go to 3 for the nuclear medicine procedure may not be the same hospital that 4 they would go to for blood work, so now you're looking at that 5 impact. Also, we're going to rely on the fact that the professional 6 standards right now are saying that if you're in the diagnostic 7 area, you question everyone about whether their pregnancy status, 8 and the standard is that if you get up into the therapy area, 9 whether it's unsealed or sealed, that you do assess pregnancy.

10 So we are to a certain extent relying on industry 11 standards right now; the standard of care to regulate rather than us 12 putting a specific regulation in place.

13 MR. CAMERON: Quick follow-up, Aubrey?

14 MR. GODWIN: Just a comment. It seems that if they 15 inquired about the pregnancy status, they've met their obligation in 16 what you've described. And I don't see why you would call it 17 unintentional if a doctor prescribed it and inquired. I don't see 18 the need for the blood test and the other things, and your logic 19 just doesn't flow well with me, I must confess.

20 MR. CAMERON: Okay. Then for NRC's consideration, we're 21 going to go to Dr. Mario Verani, who's on the board of directors of 22 the American Society of Nuclear Cardiology, for just a brief comment 23 on Part 35.

24 DR. VERANI: Thank you very much first of all, for 25 giving us the opportunity to say just a few words here.

360 1 I am a past president of the American Society of Nuclear 2 Cardiology. I want to say just a few words. What kind of society 3 is this? Most of you may not have heard of it. It congregates 4 about 4,000 physicians, physicists, and technologists, and I think 5 has been a very successful society in the employment issuing of many 6 measures in nuclear cardiology that I think have improved the field 7 considerably.

8 The Society has supported the NRC during the 9 deliberations there, but had a representative, Dr. Sircada 10 [phonetic], from Georgetown University, who participated. And 11 basically we do support the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> as it is stated now. This was 12 not what the American Society of Nuclear Cardiology had lobbied for 13 in the beginning. We all felt that there is perhaps a little bit of 14 an excess of regulation in this area, or was, for the procedure that 15 most people would qualify as a low risk procedure.

16 What's the interest of the Society in all this? Well, 17 you have to remember that of all nuclear procedures in this country 18 for imaging, cardiology procedures are now number one. And just a 19 little over half of them are now done by cardiologists, not by 20 nuclear physicians or radiologists. So there has to be a process 21 for the cardiologist to get involved in the area, and the process 22 has been a little bit complicated in the past, and I believe this 23 would simplify it to a certain extent provided that there is some 24 degree of uniformity.

25

361 1 So basically we're here today with a message to ask the 2 states -- the Agreement States to try to maintain some degree of 3 consistency here because for the training programs like ours at 4 Baylor in Houston and many others I'm familiar with around the 5 country, it becomes very difficult when you certify that the trainee 6 accomplish the necessary clinical training and have so many hours of 7 radiation training. All this -- that he goes to a state that 8 approves that and then goes to a state next door that doesn't 9 approve that. That creates a tremendous impasse and a lot of 10 confusion. So for the sake of simplicity and fairness, we at this 11 point would support the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> uniformly.

12 Thank you.

13 MR. CAMERON: Okay. There's a couple of people flipping 14 cards down here, so I guess that we'll recognize both of them.

15 MR. BAILEY: Chip, I think NRC, in looking at the 16 nuclear cardiology issue, ought to be sure about every time you 17 mention that you remind yourself that among our physicians, 18 cardiologists probably zap people more anybody else. And I'm not 19 saying that in a negative way. As far as fluoroscopy procedures, 20 most of that work is done under fluoroscope. So radiation isn't 21 totally foreign to cardiologists, and I think, as has been 22 mentioned, some of the cardiologists really look at this additional 23 radioactive stint as being a very minor thing compared to the dose 24 the patient is already receiving just undergoing the procedure.

25

362 1 So those things should be maybe weighed in the balance, 2 when you're looking at the training. I personally wouldn't have any 3 problem with cardiologists having more radiation safety training for 4 the fluoroscope.

5 MR. CAMERON: Richard?

6 MR. RATLIFF: Yes. I had a question for Dr. Verani. Do 7 you think the cardiology groups will be submitting an application to 8 NRC to be one of the approved associations?

9 DR. VERANI: Not approved associations in terms of 10 boards, for example. I believe the nuclear cardiology board is 11 probably going to submit, and that has been discussed before because 12 we do have a test at this point that I think is very fair, includes 13 a huge number of questions, including many on radiation safety and 14 all that. Members of radiology as well as nuclear medicine 15 participate in preparing the test questions and so on.

16 I don't think that the individual groups will do any of 17 that, but to what extent the individual groups will be able to act 18 as preceptors and certify, that I can't answer.

19 MR. CAMERON: Okay. Thanks, Dr. Verani.

20 One quick question that David has about something he 21 said that may have been misconstrued.

22 MR. WALTER: I don't think it was misconstrued. It was 23 talking about the number of studies -- diagnostic studies that might 24 result in greater than 500 millirem to the embryo-fetus.

25

363 1 You really have only two that have the great likelihood 2 of having something like that, and one of them is a galium scan, 3 which we know is not exactly the common scan used anymore. And the 4 other is if you're going to do a renal scan with doses upwards of 22 5 to 25 millicuries rather than the standard 15 to 18 millicuries. So 6 the renal scan really would be the one where you have the majority 7 of the people who would have a possibility of having a dose to the 8 embryo-fetus greater than 500 millirem, but you have to have a dose 9 higher than what would be naturally expected outside of the 20 10 percent range of a normal scan for that to occur.

11 MR. CAMERON: Okay. Thank you. Final comment from 12 Kathy Allen, State of Illinois.

13 MS. ALLEN: My comment sort of follows with Dr. Verani 14 as well regarding training.

15 David, you said that you -- that Part G was going to 16 propose different training requirements for iodine users. Was that 17 correct?

18 MR. WALTER: The only difference that we see in all the 19 training requirements is to not break out a separate approval of 20 less hours for iodine -- or I should say oral iodine users only.

21 Everybody else that uses strontium-89, P32, or any other unsealed 22 source therapy, will be required to have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in the NRC rule.

23 But if you were going to do oral iodine, you can come down to 80 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in three cases, and we're not going to include those two extra 25 ones.

364 1 They have two sections, one for 33 millicuries and less 2 and one for greater than 33 millicuries, and we were just not going 3 to put those in there and just let even the oral iodine users have 4 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.

5 MS. ALLEN: But under NRC's rule then, they could just 6 use oral iodine with only the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. Is that right, Cathy?

7 MS. HANEY: Yes.

8 MS. ALLEN: So if I were a physician I could get 9 licensed by NRC with 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training, turn around and submit a 10 license from Missouri -- sorry -- I'm in Missouri so I have an NRC 11 license. I can submit that to an Agreement State because I'm 12 already an authorized user, and then the Agreement State would 13 accept it or you're saying that they're going to go back and recheck 14 all the training and deny them?

15 MR. WALTER: It would be possible for the Agreement 16 State to deny them. Yes, that's correct. And that is the only part 17 that I see in this training and experience as being different, but 18 it's a major thing for those people who only use oral iodine. Now, 19 I know we have millions of endocrinologists out there who are 20 licensed, and every one of our states has probably got dozens of 21 them. But I've got one finally, after 13 years -- I've got one that 22 applied because they knew that they were looking at a change in 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br /> and he wanted to get in there under the gun.

24 25

365 1 MR. CAMERON: Kathy, thanks for pointing that potential 2 conflict out, and of course that ties into the compatibility levels 3 that will be set forth for training and experience.

4 I'd like to thank Cathy and David for their 5 presentations, and as you all know, Cathy and her staff and David 6 and the working group have put in a lot of time on this rule. Thank 7 you.

8 Okay. Fritz Sturz from the NRC is coming up to first of 9 all, briefly discuss orphan sources. Briefly, right, Fritz? And 10 then he's also going to set us up for a panel discussion on the 11 general license rule. And we have most of the panel up here, but I 12 would ask Cindy or Pete from Texas if they would like to join us up 13 here at the front for that particular discussion, and then we'll 14 have the whole panel at least around the table if not in one place.

15 MR. STURZ: Good afternoon. By way of a little 16 introduction, since I don't know most of you and probably most of 17 you don't know me, I'm an NMSS orphan myself. I was lost and now 18 found.

19 But I was primarily -- I've been in NMSS for all my 20 career in NRC, and I've been over in the other building dealing 21 primarily with the reactor in Office of Nuclear Reactor Regulations 22 and the reactor people, dealing with the other orphan source that 23 DOE won't take, spent fuel. I've been in the spent fuel project 24 office dealing with licensing of spent fuel storage and 25

366 1 transportation. I recently came back in NMSS, back where real 2 material licensing takes place.

3 I'll try to proceed here. Most of you have been 4 following this a whole lot longer than I have and I'll try to skip 5 over a lot of these background slides. Needless to say, the NRC's 6 been concerned about orphan source and the accountability of general 7 license devices for over 15 years. And there was a working group 8 established in 1996 to look at these issues, and one of their 9 recommendations was to have increased regulatory oversight and 10 continued efforts to address orphan sources.

11 Orphan source issues have been ongoing for a number of 12 years. The Commission directed the staff to take action. In 13 response to that, the NRC prepared a Commission paper dated February 14 3, 1999 -- staff efforts to address orphan sources. And I guess 15 this slide just kind of lists the subjects that I'll touch on today 16 real briefly.

17 As part of the Commission's guiding principles in the 18 staff requirements memorandum -- indicate that NRC staff should use 19 as its guiding principle that non-licensees who find themselves to 20 be in possession of radioactive sources they did not seek to possess 21 should not be expected or asked to assume responsibility and cost 22 for exercising control or arranging for the disposal when addressing 23 orphan source issues.

24 Just briefly, the NRC has been involved in a number of 25 issues to address the problems. They've been participating in

367 1 workshops, interagency meetings, seminars with federal and state 2 agencies, CRCPD, et cetera. They've been consulting with federal 3 agencies to discuss jurisdictional issues, regulatory 4 responsibilities, interacting with DOE in creating a memorandum of 5 understanding. And they've been participating with CRCPD E-34 6 committee on unwanted radioactive material sources. And we've also 7 been considering options for valuating orphan source contracts.

8 I guess in the Commission paper it also addresses 9 federal and state jurisdictions and regulatory responsibilities. As 10 you know, there are a number of federal agencies with 11 responsibilities or jurisdictions for orphan sources, and 12 everybody's not always been in agreement on the roles and 13 responsibilities to address orphan sources. But I think you know 14 more about that than I do so I won't go into that here today.

15 Since EPA funded the CRCPD to create a committee to 16 address unwanted radioactive materials and develop a national 17 program, NRC has been providing advisers to the committee, and these 18 advisers have participated in E-34 committees and are providing 19 assistance in the activities. The E-343 committee continues to 20 develop its orphan source program. Currently it is conducting, I 21 believe, two pilot programs this year and next year. One is for the 22 overall orphan source program and one is for roundup of certain 23 Cs-137 sources.

24 And hopefully, the results of these pilot programs will 25 be used by the Committee to complete its development of a template

368 1 program for federal and state agencies to respond to unwanted 2 radioactive materials incidences, and pilot roundup may serve as a 3 basis for conducting further roundups on a national scale.

4 The Commission recently approved the concept of funding 5 the CRCPD to establish and implement a national program for safely 6 dealing with the orphan sources. The decision to provide funds for 7 the national program may become effective upon completion of the 8 CRCPD E-34 committee's pilot project and finalization of the 9 national program, provided that the national program meets NRC 10 needs, the cost of the national program is reasonable, and funds are 11 available for this purpose.

12 The memorandum of understanding with DOE is intended --

13 or formalizes the letters of agreement that the NRC and DOE have 14 been operating on since 1991 to handle requests for DOE assistance 15 with sources that pose potential or actual hazard to members of the 16 public and have no viable options to mitigate hazards. The 17 memorandum of understanding was approved by the Commission and 18 became effective on June 18, 1999.

19 DOE recently completed a pilot program for recovery of 20 americium/beryllium sources, and they recovered -- in that pilot 21 program they recovered 56 candidate sources, and they've begun a 22 second phase of the pilot program in July.

23 NRC has worked with DOE to establish the criteria for 24 the second phase of the pilot and identified potential candidates.

25 The NRC is working with the states and regional offices in the

369 1 process to identify additional potential sources and NRC continues 2 to work with DOE to establish routine acceptance of greater than 3 Class C material such as americium, beryllium, and plutonium P-38 4 sources.

5 On the international front, NRC staff has participated 6 in the December '98 meeting with the Department of State concerning 7 creation of the International Radioactive Source Management 8 Initiative. Department of State is leading the initiative in 9 response to international requests for assistance in the areas of 10 orphan source management and clearance levels for metals. The 11 International Radioactive Source Management Initiative is intended 12 in part to develop a program for the prevention, identification, 13 tracking, response, and remediation of radioactive materials being 14 illegally imported and exported to and from nation states, including 15 the U.S.

16 The IRSM structure includes a steering committee and 17 four subcommittees. The steering committee and subcommittees 18 include representatives from Department of State, EPA, Department of 19 Energy, Department of Transportation, CRCPD, Customs, and the 20 states, industry and other stakeholders. The four subcommittees 21 include Tracking and Clearance, Stopping Future Losses, Technology 22 Monitoring and Retrieval, and the Education and Training 23 Subcommittees. The steering committee proposed that the NRC should 24 co-chair the Tracking and Clearance subcommittees and chair the 25 Stopping Future Losses subcommittee.

370 1 NRC intends to tend to all the steering committee 2 meetings and will provide representatives for the steering committee 3 as well as the subcommittees.

4 That concludes my presentation and if we get set up, 5 stay tuned for the other half of the picture on how NRC is dealing 6 with accountability for devices.

7 MR. CAMERON: Do we have any issues or concerns with the 8 orphan source process? Stan?

9 MR. MARSHALL: Sometimes today's orphan source becomes 10 tomorrow's greater than Class C waste to be disposed in Nevada, at 11 the Nevada test site. And I'm only on the edge of being involved 12 with any of it. Obviously, I have the DOE exemption in the way of 13 my involvement as a regulator, but it seems that EPA and the state 14 equivalent of an EPA agency seems to drive the greater than Class C 15 disposal issue. Is NRC to be involved with orphan sources that 16 become greater than Class C waste for disposal?

17 MR. STURZ: I thought DOE was responsible for disposing 18 of greater than Class C waste, so I think the second pilot program 19 DOE is taking is greater than Class C waste -- or the other sources 20 and storing them. They've not going to dispose of them. I think 21 the idea is they're going to store them until -- if they get a 22 repository they eventually will go to the repository.

23 MR. CAMERON: Okay. We have -- Joe?

24 MR. KLINGER: Yes. There is an update now. I just 25 attended a meeting of the IRSM. They're now six subcommittees.

371 1 There's six. And there is the cost free expert that they're looking 2 for. I think everybody -- there was something that went out.

3 They're looking for somebody to go to Vienna for one to three years; 4 a very attractive place to go.

5 But that's to work with the international community.

6 They're very interested in what we're doing here in this country, 7 and we -- people on the E-34 really appreciate the efforts of NRC 8 and EPA and DOE. In particular, DOE's doing a great job right now.

9 MR. CAMERON: That's great. Roland?

10 MR. FLETCHER: I guess my question goes to the 11 commission guiding principle. Essentially, it says that if a --

12 let's say a landfill comes in possession of a source that of course 13 they didn't want, they don't have any responsibility for -- I 14 understand perhaps for having it, but for arranging for its 15 disposal. It don't understand how then -- they have to be a part of 16 arranging for its disposal, it would appear to me, if only in 17 communicating with agencies that can actually do the disposing.

18 The wording is a little troubling.

19 MR. CAMERON: Okay. Thanks, Roland.

20 Don?

21 MR. BUNN: There was a time when NRC worked along with 22 U.S. Customs to monitor -- or to make sure monitoring devices were 23 at our borders so we could possibly detect things that were coming 24 in. And in fact, they did pick up some pretty significant incidents 25 as a result of that. Maybe ten years ago or so, NRC decided to pull

372 1 out of that support for Customs, and since then there's no 2 monitoring that I know of at the border. This, I think, needs to be 3 considered for reenactment if we're going to look for these orphan 4 sources, or at least see them coming across the border.

5 MR. CAMERON: Okay. Thank you very much for that 6 comment, Don.

7 And I think that we're ready to move into the GL 8 discussion, and what I would suggest, as we've done the other 9 panels, let's have Fritz do his presentation and then let's go to 10 the four states -- representatives of the four states that we have 11 to say whatever they have, and then let's open it up for discussion.

12 And I would note that Mel Fry is listed as being from Oregon. So --

13 he isn't. And we have Cindy Cardwell and Pete Myers up here from 14 the State of Texas.

15 So let's go to Fritz and then maybe go to Cindy and 16 Pete, and then Mel, Ray, and finish up with Aubrey. Go ahead, 17 Fritz.

18 MR. STURZ: I'll try to be brief on this, but I think 19 this may take a little longer. But we'll breeze through some of the 20 slides and they are in the handout, and I guess extra handouts are 21 in the back. The handouts have been passed out to the table, but 22 for the audience there's others in the back there.

23 As I said previously, NRC's been concerned about the 24 accountability of general license devices for 15 years now, and on 25 November 13, the NRC -- of '96, the NRC staff and stakeholders were

373 1 provided evaluations of NRC and Agreement State working group 2 recommendations to the Commission. And out of that, as a result, 3 the Commission directed the NRC staff to consider the feasibility 4 and costs of an annual registration program to reexamine 5 accountability of risk-informed performance-based regulations of 6 material licensees.

7 And in response to NRC, in April of '98 the Commission 8 directed in part the staff development to implement the registration 9 program for general licenses possessing devices identified by the 10 working group as needing increased regulatory oversight. The SRM 11 also directed the staff to establish a registration program through 12 two rulemaking efforts and follow up with general licensees who 13 either did not respond to registration program or had discrepancies 14 in their responses.

15 In response, the staff prepared the February 3, 1999, 16 Commission paper, which addressed the staff efforts to address 17 orphan sources, and also is working on two rulemakings to establish 18 and define a general license registration program. And it's working 19 with the contractor to develop a general licensing tracking system.

20 Just to touch on some of the things that have occurred 21 since the last Agreement States meeting -- in March, 1999, the 22 Commission established an interim enforcement policy for violations 23 during the initial cycle of the registration program. The purpose 24 of this policy is to remove the potential for the threat of 25

374 1 enforcement action to be a disincentive for the licensees to 2 identify deficiencies.

3 Under the interim policy, enforcement actions will not 4 be taken for violations that are identified by the general licensees 5 and reported to the NRC if reporting is required, provided the 6 general licensee takes appropriate corrective action to address the 7 specific violations and prevents reoccurrence of similar problems 8 and the general licensee has undertaken a good faith effort to 9 respond to NRC notices and provide the requested information.

10 On July 27, the NRC held and Agreement State workshop.

11 This workshop was originally planned as an opportunity to create a 12 forum for discussing the second rule, and while gathering comments 13 during the comment period and to gain insight from Agreement States 14 experience with similar programs and the issues that will affect 15 implementation of the registration program. However, the Federal 16 Register notice of the proposed rule was delayed and finally 17 published just the day before the meeting, but we went ahead with 18 the meeting anyway and still took it as an opportunity to gain 19 Agreement State insights and to create a forum to discuss and 20 identify and clarify the proposed rule, as the information would 21 feed into later formalized comments which we hope to get from the 22 Agreement States.

23 And as you can see up there, these were the main topics 24 that were discussed at the meeting. I won't go into any more detail 25 about that.

375 1 The NRC also has planned another public meeting to 2 discuss the proposed rule too, about the registration program on 3 October 1. The details of the meeting can be found in the September 4 3 Federal Register. The purpose of this meeting is to gather 5 information on implementation issues, and this meeting will be 6 facilitated by Chip and will address -- I guess issues will 7 initially be addressed by a panel of various vendors and then will 8 be open to the audience for discussion.

9 To get into the general license and registration 10 program, the registration program is going to be established through 11 two rulemakings. The first rulemaking provided the regulatory basis 12 for subjecting general licensees to a registration by amending the 13 Part 31 to add a requirement to 31.5, that they must respond to 14 written requests for NRC information. The final rule was published 15 on August 4, and now becomes effective October 4, 1999.

16 The second rulemaking contains specific requirements for 17 the registration program. It establishes fees for registration and 18 addresses Agreement State compatibility requirements and addresses 19 enforcement issues. Specific provisions of the rulemaking include 20 clarifying which sections of Part 30 apply to all Part 31 general 21 licensees. It adds clarifying requirements about 31 general 22 licensees. It adds specific provisions for general licensees 23 subject to registration and clarifies the requirements for 24 manufacturers and distributors of devices.

25

376 1 The proposed rule requires that general licensees 2 appoint a responsible individual, while the person who holds the 3 license is usually a corporation or institution rather than an 4 individual. For the general licensee to comply with existing 5 regulations, an individual must be aware of the requirements and be 6 authorized to take the required actions. It also adds a requirement 7 to report changes of address, and not only includes the change --

8 this also includes the change of the name of the company. If the 9 general licensees move their operations without notifying the NRC or 10 appropriate Agreement State, they may be difficult to locate, 11 contact, or inspect.

12 The proposed rule for general licensees adds a 13 requirement to require that if a site is taken over by a new entity 14 or new general licensee -- includes that the new entity must provide 15 a new responsible individual information and identify the device 16 serial numbers. It also expands the reporting requirements for a 17 transfer of advice to a specific licensee to include the recipient's 18 license number, the device serial number, and the date of transfer.

19 And it also restricts the length of time allowed for a device to be 20 in a storage only state, and it defers leak and shutter testing 21 during storage.

22 The general licensee intends to use the device after a 23 period of more than two years of non-use, the device could be sent 24 back to the supplier to be held under the distributor's specific 25 license until later use. If the period of storage exceeds the

377 1 normal interval for testing, testing will not have to be done until 2 the device is put back in service.

3 Okay. It also -- the proposed rule adds specific 4 provisions in 31.5 for general licensees subject to registration.

5 It adds the criteria for devices to be registered. And you can see 6 the criteria up here, and these are based on the NRC Agreement State 7 working group recommendations study. It provides information 8 required for the registration and the fee for registration, which 9 apparently right now is at $420.

10 The proposed rule also has provisions for vendors. It 11 adds -- revises the required contents of the quarterly material 12 transfer reports to include information on devices returned for 13 replacement, the name and phone numbers of the responsible 14 individuals, and the mailing address of the location of use, not the 15 corporate headquarters, and also includes additional labeling 16 requirements for the devices. It also revises record keeping 17 requirements of the vendors and revises the content and timing of 18 certain information provided by vendors to their customers before 19 the devices are shipped.

20 Specifically in the Federal Register notice, there's 21 about five questions that the Commission is looking for specific 22 answers -- or is looking for specific comments on. They're in the 23 handout. I'll just run through them briefly. They deal with 24 registration requirements. Should they include provisions that 25

378 1 require general licensees to complete registration by a certain 2 time, whether or not the NRC requests a registration?

3 The second question deals with new devices obtained by 4 registrants to be registered when the annual registration is carried 5 out, without NRC having earlier contact, after additional devices 6 are received. The third question deals with whether a general 7 licensee should be required to assign a backup responsible 8 individual. The Commission is looking on comment to how to best 9 achieve and enforce the intent of full disclosure of information 10 required to be provided by the general licensee customers by 11 distributors. Should it be made early enough to be considered in 12 the decision to purchase?

13 And they also -- the Commission is seeking comment on 14 the advantages or disadvantages of a national data base of general 15 licensees and their devices.

16 As an integral part of this registration program, the 17 NRC is developing a new automated system, a general licensing 18 tracking system. It's intended to facilitate implementation of the 19 user device registration and NRC contract follow-up, and it also is 20 going to maintain the general license information. It will include 21 information about the general licensees, the devices each licensee 22 possesses under the general license, and the vendors of generally 23 licensed devices.

24 The GLTS will replace the existing general licensing 25 data base, and is being designed to house information currently in

379 1 that data base, as well as the additional information that's going 2 to be requested in the second rulemaking. It will also generate ad 3 hoc reports and disseminate information on lost or unaccounted for 4 devices.

5 The general licensing tracking system will accommodate 6 growth of the data base to at least 150,000 licensees. The growth 7 of the data base may occur because of increases in the general 8 licensee population or additional licensees being subject to 9 registration. The NRC is currently conducting a materials risk 10 assessment and will evaluate the results of the study to determine 11 if additional licensees should be included into the registration 12 program. Several future enhancements of the GLTS are planned, 13 including on-line registration, two-way communications with other 14 programs, such as NMED or the National Sealed Source and Device 15 Registration Program.

16 I've included a number of slides in the handout which 17 highlight a number of changes since you last heard about the rule, 18 last October. Hopefully this will assist you in directing you to 19 any specific issues that you want to look at in the proposed rule.

20 In summary, initiation of the registration program is 21 based on the first rulemaking, and when we implement it in mid-year 22 next year, with the mailing of initial registration scheduled for 23 March, 2000. The registrations will be sent to all general 24 licensees subject to registration, but will be simplified in that 25

380 1 the registrations will not include any key additional provisions 2 contained in the second rulemaking.

3 The registration program will include a short amnesty 4 period for general licensees who identify a lost or unaccounted for 5 device during the initial registration cycle and who make a good 6 faith effort to find the device. Following initial implementation, 7 the registration program will continue on an annual basis in 8 accordance with the provisions of the second rulemaking. When the 9 second rulemaking becomes effective some time in calendar year 2001, 10 licensees and vendors will be required to provide additional 11 information addressing the second rulemaking.

12 Fees will be charged for registration and general 13 licensees providing incorrect or inaccurate information or who 14 improperly dispose of devices will be subject to enforcement actions 15 and civil penalties up to three times the cost of authorized 16 disposal. The registration program is expected to provide a number 17 of benefits in that the GLTS will increase the accountability of 18 devices. Hopefully, it will provide a more efficient system for 19 maintaining general licensee device and vendor data, searching data, 20 creating reports, and disseminating the data.

21 Hopefully, we'll have a greater accuracy in licensing 22 data and means for data validation, will provide efficient means for 23 contacting and mailing between NRC and the general licensees. We're 24 expecting, I guess, it's going to provide registration of 25 approximately 5,000 to 6,000 NRC general licensees. And also

381 1 hopefully, it will provide access to certain general licensee data 2 by the public, especially concerning lost or unaccounted devices.

3 Thank you.

4 MR. CAMERON: Okay. Thanks, Fritz.

5 Before we go to the state panel, I would just like to 6 repeat the notice that Fritz talked about for the October 1 meeting 7 in Washington on this issue. And we would invite participation by 8 any Agreement States and would welcome that. And also if anybody 9 has a particular vendor that they think might be well represented in 10 the vendor roundtable that we're going to use to focus discussion, 11 I'd appreciate getting any leads on that.

12 So, Cindy, do you want to start off?

13 MS. CARDWELL: Pete's going to start.

14 MR. CAMERON: Pete's going to start? All right.

15 MR. MYERS: The organization of our presentation this 16 morning is I'm going to talk a little bit about how we run our 17 program and how we got to where we are now, and then Cindy's going 18 to talk a little bit about the comments on the proposed rule.

19 We started our program in 1993, and the way it ran was, 20 of course as most of you already do, we get quarterly distributor 21 reports. Once we get those reports, we know to whom we need to send 22 letters soliciting their applications for a general licensee 23 acknowledgment. In that application, in 1993, was name, address, 24 device, model number, device serial number, source serial number, 25 and point of contact. And then we would issue an acknowledgment to

382 1 them, including conditions of use from the sealed source and device 2 safety evaluations.

3 The concept there was to provide information that we 4 thought was necessary for the users of these generally licensed 5 devices to use them in a safe manner, understanding that the general 6 licensees don't have any -- are not required to have any training, 7 experience, or indicate to us what their facilities are like or how 8 they're going to be using these devices. We thought we would go 9 through the sealed source device safety evaluations and as a user 10 friendly kind of an approach, to include some of that important 11 information on the acknowledgment.

12 So the GLAs included device and source specific 13 limitations of use, leak test intervals, on and off testing 14 intervals, record keeping requirements, and such.

15 In 1995, we changed some of our procedures, and those 16 changes continue to the present. Now we've reduced the number of 17 devices for which we issue acknowledgments, and we no longer record 18 the serial numbers of the devices and the sources. And the reason 19 for that was it just -- we didn't have the resources in order to do 20 what we wanted to do in as timely a manner as we thought was 21 necessary to serve our customers. It was taking a lot of time to 22 create the device-specific data base that included conditions of 23 use.

24 For instance, we would need to comb through the safety 25 evaluations and create a data base for specific model numbers so

383 1 that when somebody applied for an acknowledgment for a specific 2 model, we could call in these conditions of use and then to 3 correspond to get correct model numbers and serial numbers.

4 I'm going to make a suggestion here in a little bit --

5 in maybe another slide to try to solve one of these problems, 6 anyway.

7 Once the licensees get their acknowledgment and they 8 have their device, our program requires a self evaluation or 9 inspection once a year. There's a 30 item administrative checklist 10 that includes a lot of the things that are required for them to 11 really be using these devices in a safe manner. And also that self 12 evaluation includes an inventory that they are supposed to perform 13 but keep on file for our inspectors to come and take a look at.

14 That inventory does include device model number, device serial 15 number, and sealed source serial number, and then our staff is 16 programmed to come around once every five years to evaluate their 17 program.

18 Now, a couple of recommendations -- one of the things 19 that really slows the process down is this bit of having to get the 20 reports from the distributors quarterly and then to send letters out 21 to the people who receive these devices, asking them to submit an 22 application to us. It would really, really be much more efficient 23 if we could come up with an OAS standard application that would be 24 included within -- or would accompany the device, that the receiver 25 of the device would have this form. On it would be preprinted

384 1 serial numbers so that there wouldn't be any problem in transcribing 2 serial numbers from one form to another, and it really, I think, 3 would create a much more efficient method for processing these 4 applications.

5 It would be sort of similar to a warranty card, if you 6 will. If we could just come up with a standard form that we could 7 all use instead of having separate forms that the manufacturers 8 would have to think, Gee, which form do I put with this guy's? So I 9 think that would be a great thing, if we could come up with that.

10 The other thing that is a recommendation that perhaps 11 Cindy's going to talk about also is that we ought to have the 12 distributors continue sending these quarterly reports to us, even if 13 they are negative reports, and without us having to request them to 14 send them.

15 Okay. Cindy, here's your part.

16 MS. CARDWELL: Thanks, Pete.

17 We took a look a few weeks ago at the proposed NRC rule 18 that's just come out; Phase 2 I think Fritz called it. And I have 19 some comments on that rulemaking. And actually, we found that -- I 20 don't want to say surprisingly, but we kind of were -- that we were 21 in general agreement with the proposed rulemaking, most parts of it.

22 We actually found several good things that we probably will look 23 into changing our rule to be compatible with, be equivalent to.

24 We like the idea of the responsible individual. When 25 you have to put your name on the dotted line and sign and certify

385 1 that you're responsible, that seems to automatically create an 2 awareness that there is something out there that you're responsible 3 for: radioactive material. So we like that concept.

4 We also like the concept that NRC's put in the proposed 5 rule on the storage restriction. They've got a two year restriction 6 in there, and the thinking being that if it's in storage longer than 7 two years, the out of sight, out of mind philosophy comes into play, 8 and that just lends itself even more so to these lost, quote, 9 sources that we end up with -- a lot of these GL devices.

10 We really like the idea of distributors being required 11 to provide additional info to the GLs like, for instance, the rules 12 of the Agreement States that do have these programs in place and 13 those that are anticipating putting them in place. The cost of what 14 it's going to take -- the regulatory cost of what it's going to take 15 in order to possess one of these GL devices -- we really think 16 that's important for them to include in what they have to distribute 17 to the general licensee along with the devices.

18 And we really like the idea of having in rules specified 19 what information is supposed to go on those quarterly reports. Now, 20 the NRC proposed rule has an actual form, but whether they fill out 21 the form -- at least as long as they have the equivalent 22 information, we're really moving towards consistency, and I think 23 that has a lot of implications in several of these other 24 requirements. So -- and it goes back to what Pete's talking about 25

386 1 in getting with that consistency in what we're asking them to submit 2 to us.

3 In terms of the specific questions that NRC asked for 4 comment on, the first one that Fritz went 5 over -- we really think that the rule ought to require that general 6 licensees register their devices, regardless of whether or not 7 they've had an NRC request to do so. In the proposed rulemaking, 8 what NRC pointed out was that if they, for some reason, fail to 9 notify the general licensee that they had gotten their quarterly 10 report and the quarterly report indicated that they had x number of 11 devices and they needed to register them, that the general licensing 12 would basically fall outside of the rule. And that just didn't seem 13 right. If it's good for one, it's good for everybody, so we think 14 the rule ought to require that.

15 And again, if you think back to the -- one of the major 16 reasons for the implementation of this rule is tracking of these 17 devices. You're not going to have consistent tracking if you're 18 only going to get to those that you actually go out and solicit the 19 information for. We think it should be required for everyone.

20 Specific comment number two -- we believe that the 21 registrations, as NRC calls them -- we call them acknowledgments so 22 as not to confuse them with our x-ray side of the program -- the 23 registrations we believe should be updated with the addition and 24 deletion -- and that means permanent deletion. We're not talking 25 about transfer here -- of devices. Again, if you go back to the

387 1 objective, one of the primary objectives of the rule was for 2 tracking. And if you only -- NRC's proposal, if we understood it 3 correctly, was that at their annual renewal they would have them 4 update any deletions or additions they had of devices.

5 You go back to tracking and you happen to lose one in 6 that half a year, you don't have any information as to where it 7 went. You have to go back further than just what's on their 8 registration. So we think that ought to be reported with each 9 addition or deletion.

10 Specific comment number three -- we don't see any need 11 for a backup responsible individual, even though that was a 12 recommendation of the working group. One of our staff said, That's 13 akin to requiring an assistant RSO, and we don't to that. And 14 besides that, that would be a BRI. That's another acronym we have 15 to learn. Let's just not do that.

16 Specific comment number four -- we really like the 17 words, prior to purchase in the requirement for the distributors to 18 provide the information, especially on the cost of this thing, prior 19 to a general licensee making that commitment, or that purchase, if 20 you will. If we put in there the fact that you're going to be 21 subject to inspection --whether or not that has a cost associated 22 with it, I guess depends on their compliance -- the fact that the 23 NRC's going to charge them $420 to have a registration, that they 24 are going to be required to register. We think that basically is 25

388 1 essential in determining whether they want to take on the 2 responsibility of possessing one of these devices or not.

3 And really, you can turn it around and say, If it were 4 you, wouldn't you want to know? If someone comes out and says, It's 5 only going to cost you $3,000 for this nice device we have. We have 6 such a deal for you. But oh, by the way, here's another couple 7 hundred here, maybe another couple hundred here, and you're 8 responsible for this and this -- we think that's, in terms of up 9 front government, that the distributors ought to provide that same 10 information to them.

11 In terms of asking for comments on a tracking system or 12 a national data base, we started talking -- this national data base 13 sounded good. There's one place we can all go and look for this 14 information. And then we started looking at what NRC was putting 15 in -- listed as some of the advantages and disadvantages in the 16 proposed rulemaking.

17 One of the things that stood out to us, besides the 18 things that -- how are we going to maintain security, et cetera, was 19 the cost. Who's going to implement and maintain this thing? And 20 they listed -- could it be somebody like NRC, CRCPD, or an 21 independent third party? When we saw independent third party, the 22 dollar signs started rolling up. Somebody's going to have to pay 23 for it, and while if Texas were a republic again we'd be the 24 eleventh most wealth country, that wealth is not concentrated in our 25

389 1 bureau. And we're not going to pay for anybody to maintain that 2 thing.

3 So we started looking at what's already out there, and 4 as Fritz already mentioned, NMED's out there. When you lose a 5 source -- and think back again to the objective. We're going to try 6 to track ones that are lost, maybe damaged, if we can -- NMED 7 already asked you -- or requires you to put that information in the 8 system: model number, device number, serial number, everything that 9 you can get off of a lost source.

10 At that point in time, we think it becomes critical --

11 and I'll quote Greta from yesterday. She said, Communication is 12 paramount, that the agencies know -- and I mean state controlled 13 programs here, radiation control programs -- which ones of us have 14 implemented already such a program and may already have such a data 15 base, which ones of us plan to, and to develop the data base. This 16 gets back again to what we mentioned earlier. We think it's very 17 important, in fact, critical, that the quarterly reports all be 18 consistent, because then we'll all got consistent information to put 19 in our data bases.

20 So therefore, if we have the information in NMED, we 21 say, We've lost a source, you can see all the information we need 22 about that lost source in NMED. We know who has what data base. If 23 there are any tracking problems, they ought to surface at that time.

24 We ought to be able to put out some kind of blanket e-mail, if you 25 will, to each other, and say, We've lost a source. We've reported

390 1 it to NMED. Do you have this in your data base? And talk with each 2 other about it before we go jumping into some national thing. If 3 indeed there is a problem in the tracking and it surfaces at that 4 time, then we can examine options for some kind of national system.

5 And our thinking in that was, Let's not jump to what we 6 consider the far extreme that's going to cost a lot of money, be 7 time intensive, resource intensive, if we've already got the seeds, 8 if you will, of being able to do so in our own states and we just 9 need to talk with each other about it.

10 And that's what we have on our comments.

11 MR. CAMERON: Okay. Thank you very much, Cindy and 12 Pete. And let's go to Mel.

13 MR. FRY: I talk better than I write, so I don't have 14 any Powerpoint for you to look at.

15 North Carolina comes into this tracking of GL devices 16 from a long history of registering Gls, probably for well over 20 17 years. The problem lies at the very root of the concept of the 18 general license and the information that the recipients have at the 19 point we try to make some contact with them. And you've all had the 20 same problems we have if you've tried to follow up with the contact 21 people. Many of the GLs go through two or three people to get where 22 they are. The general contractor buys it and then the electrical 23 contractor gets it, and the hotel that has it possesses it until 24 they sell it to the next chain the next month, and on it goes.

25

391 1 The idea that you have a responsible party that's 2 knowledgeable about what they've got and what to do with what 3 they've got is flawed all the way to the bottom of the GL concept.

4 You don't have a knowledgeable party. they don't know what they've 5 got. And they have no idea about what their responsibilities are.

6 And to build a new program, to expand the existing program, to put 7 additional requirements in there for this untrained individual who 8 doesn't know what he's got just seems to be basically flawed.

9 The issue of generally licensed device, especially 10 portable ideas -- and we don't generally license anything in North 11 Carolina that's portable. If it's got wheels on it, look out. And 12 we just simply don't recognize, and our rules don't allow for the 13 recognition of a portable device. The issue seems to constantly 14 come into play relative to what should be generally licensed, that 15 it's a dose consequence. And all of the discussion we've been 16 having today has had to do with accountability, and most of the 17 generally licensed devices are not large does producers. That's 18 been the thing we've been evaluating before we generally license 19 something to start with.

20 But the issue for us has become accountability and the 21 tracking of those when they're stolen, when they're lost, when 22 they're surplused, when it's recycled. And letting them know ahead 23 of time, getting some minimal training in their hands would 24 certainly be a start. I think the crux of this is in underlying 25 issues. We've talked earlier on other subjects about ALARA and the

392 1 like, and is the issue of, are you just going to let the small stuff 2 go? When the alarms go off, tell them to call Washington or call 3 the vendors.

4 You've got two major programs with the scrap and 5 recycling people wanting to make certain that there's not a single 6 becquerel in anything. And then you have another major 7 initiative -- you don't have to turn to two separate agencies -- two 8 major initiatives within the NRC to see how much material we can 9 recycle is how much radioactivity can we make sure it's got in order 10 to have clearance rules. The loss of control over the generally 11 licensed devices is the same issue as you look for more and more 12 things that you can have less control over, then how are you saying 13 then we just won't let the small stuff go.

14 And it doesn't really matter that you got radioactive 15 diapers in the landfill. Just put them there. Or that you've got 16 radioactivity in the scrap -- that's probably a wonderful place for 17 most of it. It just doesn't make sense for a lot of it.

18 MR. CAMERON: Okay. And we're going to go to Ray and 19 then over to Aubrey. And I think it would bear some discussion to 20 go back and focus on what Mel's point was there.

21 Ray?

22 MR. PARIS: I'll make mine brief. We've been 23 registering GLs for about ten years. It's worked. And 24 accountability, as you mentioned, Mel, is a great asset when people 25 know what they got. We send out a renewal by letter and people --

393 1 annually, and they find out and they are becoming aware they do have 2 the stuff. And so it's worked.

3 And so what I've done is just simply give you -- if 4 anybody wants, it's our web page and it has our rules, the fee 5 structure, the whole thing. We charge $100 per year per device.

6 NRC I think is going to go 420 or something like that. But ours 7 is -- so it works. If you're interested in what we've got, take a 8 look.

9 MR. CAMERON: Okay. Thank you very much, Ray.

10 Aubrey?

11 MR. GODWIN: Fortunately a lot of the material's already 12 been addressed, but there are a couple of points I would call to 13 your attention and I think you'll need to look at.

14 The proposed Rule 2, which is still proposed, has in it 15 some sizes of devices that would require registration and below that 16 would not. It was agreed to by the general license committee that 17 was working with NRC on it to these levels. I personally feel that 18 one of them's a little high. The cesium one at 10 millicuries just 19 seems a little bit high to me, to not require registration until you 20 get to 10 millicuries of cesium.

21 But that's something I think that they would like to 22 hear from the states on, and certainly I hope that each of you will 23 take the time to write in and express an opinion relative to that 24 and other issues.

25

394 1 The next step is the one on the national data base.

2 They are specifically asking questions about the national data base, 3 and I think you need to look at that a little bit. I have a 4 question for you first. Would the states around the table raise 5 your hands if you have a data base of your general licensees?

6 Oh, that's a good show. A lot better than I thought it 7 would -- including serial numbers? We've dropped a few out there.

8 What the intent would be -- with the national data base 9 would be a tracking system to keep up with the devices, not like we 10 have a specific license where it's a licensee responsibility but 11 where the government, whoever we are, would keep up with it. There 12 are advantages to that. Whenever there's a problem, with a model 13 number you can quickly identify who has them and how to get to them.

14 If you have a source missing, you can track where it turns up and 15 comes back. If a significant number of states do not have a 16 tracking system, it becomes a problem being able to track anything.

17 Ten states at least -- or nine now, would have to depend 18 on NRC for a tracking system. At the discussion we had in July, the 19 proposal would be that NRC would consider at least developing and 20 funding the running of such a national tracking system. As they 21 lose their state that they have control over, I'm not sure they'd 22 continue to make that commitment because this is probably a couple 23 of million dollar project per year, and that would be an appreciable 24 financial burden if they have to support it by their fees from their 25

395 1 general licensees. Your comments should be made relative to this 2 system also.

3 If it's adopted, it would -- there are a couple of 4 things you need to know in the concept of where it could operate.

5 If adopted, there may be only one report submitted, and that's given 6 to the NRC who in turn would combine them all together and then send 7 you your copy. I don't have any problem with that if NRC does that 8 in a timely manner, but I'm not sure that when they talk to their 9 lawyers they want buy that responsibility. So you need to be aware 10 that would be concept.

11 Another concept might be that we at the states would 12 have to enter the data into their national data base through one of 13 our terminals, which you need to think about your work load 14 considerations in that case.

15 Another point that really was just sort of bounced over 16 that came up in the meeting I think you need to also look at --

17 there's a proposal that when this gets fully implemented, the civil 18 penalty would be two to three times the disposal cost for a device 19 to encourage companies to not, quote, lose a source, but to actually 20 pay for disposal because it's cheaper that way. We don't have the 21 same policy the Commission does about not charging the third party 22 who ends up with a source disposal costs.

23 If you're unfortunate enough to be a landfill and get a 24 source and it's got to be dug up -- somewhat like Texas, Arizona 25 might not be the eleventh largest in the world but I can tell you

396 1 the wealth of Arizona is not in their radiation program. And we 2 won't pay a whole bunch of money to somebody to dig it up. They're 3 going to sue whoever they can find out shipped it to them and suits 4 tend to get very expensive, so that does tend to discourage people 5 from doing this.

6 And the Commission might want to think about their 7 policy a little bit relative to that. The third party can't 8 contribute to the disposal of these sources illegally by just 9 agreeing to accept things without any kind of review. And I would 10 suggest that you need some incentive to these disposing companies 11 and melting companies to survey and make sure they're not getting 12 unwanted trash. So you might want to look at at least some 13 liability for those folks.

14 And that's my comments on the GL provision as it 15 currently stands.

16 MR. CAMERON: Okay. Thank you very much, Aubrey.

17 We've heard a number of specific comments on the GL rule 18 and registration generally, and I think they've been generally 19 positive. I guess I would, before we open it up to all of you, give 20 anybody on the panel an opportunity if they care to speak to the 21 point that Mel raised.

22 Cindy?

23 MS. CARDWELL: Well, I'm not speaking to Mel's point.

24 I'm just apologizing to Mel for putting you from Oregon. You don't 25 sound anything like Ray. I'm sorry about that.

397 1 MR. CAMERON: Yes. How can two people from Oregon have 2 such opposite views?

3 Okay. Larry, did you -- you had something you wanted to 4 say? It's Larry Camper from the Nuclear Regulatory Commission.

5 MR. CAMPER: Thank you, Chip. I want to make a couple 6 of comments about the national data base, the General License 7 Tracking System.

8 I follow your comments with a great deal of interest, 9 having been very much involved and working closely with Don Cool as 10 the division director as we work to develop the GLTS. And what I 11 want to really do is plant a seed in your mind to encourage you to 12 look closely at what's going on in the development of GLTS and 13 encourage you to think very seriously about using it. I'll take a 14 couple of minutes to share with you some background about that 15 system that I think will be of value to you to know.

16 In the federal sector, we now have a piece of 17 legislation called the Klinger-Cohen Act, and it required all 18 federal agencies that were developing an information technology 19 project of certain dollar amounts to go through a fairly rigorous 20 process; a rigorous process where you had to look at and examine all 21 of the various alternatives that were available to you for a 22 particular IT system, where you had to clearly define the 23 requirements of the system and put it through a fairly rigorous 24 feasibility study.

25

398 1 Now, in developing the GLTS, we identified about 222 2 requirements for the system. We looked at several alternative 3 systems in other federal agencies and in state agencies. In fact, 4 some of the ones that have been mentioned here today we took a long, 5 hard look at. And we have developed what we think -- or propose 6 what we think would be a very sophisticated system.

7 We then had to go defend the system before what's called 8 the Information Technology Business Council, who puts us through a 9 very scrutinous and rigorous examination of the system that you want 10 to proceed to develop. This particular system exceeded the trigger 11 of $500,000 and therefore we had to justify in fairly clear and 12 certain terms why we should proceed with the system. What it also 13 does is bring to bear a certain amount of responsibility for 14 managers not to change the system once you decide what it is you're 15 going to proceed with.

16 One of the primary reasons why IT systems fail of any 17 dollar amount is that managers cannot come to rest on what they want 18 the system to do. You have to define the box: the shape, the size, 19 the color. You can go back at a later time and augment the box to 20 make changes, but you cannot decide to change course in the middle 21 of development.

22 So it's been put to a very, very rigorous process. And 23 one of the things that concerns us greatly about the GLTS is that in 24 our jurisdiction -- we're talking about on the order of 5,000 25 licensees, 20,000 or so devices -- 24-25,000 devices, in that

399 1 order -- well clearly, you have far more devices that you control 2 than we do. And one of our biggest concerns throughout this entire 3 process -- we have gone to a great deal of trouble to follow 4 Commission direction. We have gone to a great deal of trouble to 5 develop a very sophisticated tracking system, and yet it's going to 6 house only a very limited number of devices. We would like very 7 much to see a national tracking system.

8 And what I want to do is encourage you to take a good 9 hard look at the system. Feel free to call us up and ask us 10 questions about the system. The software that's being used is 11 relatively inexpensive for you to secure. Several hundred dollars 12 will do it. There are some security firewall issues with the system 13 that have to be addressed, but they're not insurmountable. Cindy 14 raised a very valid point about ongoing maintenance. And Don can 15 correct me if the budget numbers have changed since I left at the 16 end of June, but we had programmed into the system something on the 17 order of a couple of FTE per year and about $300,000 or so for 18 ongoing maintenance of the system.

19 We know that the success of the system and the success 20 of the registration program is going to be that we maintain in an up 21 to date manner. Therefore, it would be cost-effective to add 22 additional GL devices to the system because the base line cost for 23 ongoing maintenance has been considered in the developmental issues.

24 So I just want to plant the seed in your minds at this 25 juncture, take a good hard look at the question that's being asked

400 1 now about the GLTS, and individually, take a good, hard look at the 2 system. Call us up. Don will be happy to answer questions, I'm 3 sure. I will, from what I can recall of the system. Fritz, who is 4 the section leader now -- and it would be wonderful if we could 5 really get to a point where there was in fact a national tracking 6 system where all the GL devices were accounted for in that system.

7 And for those of you in states where you have very 8 limited systems for tracking at this point in time -- in some cases 9 they're even manual systems -- I encourage you to take a good, hard 10 look at it, because the level of sophistication and the level of 11 scrutiny that has gone into it is really state of the art.

12 Thank you.

13 MR. MYERS: Larry, I was wondering, the GLTS, even if 14 the NRC puts it together for the NRC states only, is it going to 15 include non-GL sources too?

16 MR. CAMPER: No. It is a very set group. It's the 17 group that Fritz -- the working group identified a particular set of 18 GL devices that should be tracked: cobalt-60, strontium-90, 19 transuranics, and cesium-137. It is that group initially that the 20 system is being developed for, but as was mentioned, the system has 21 incredible capacity for expansion and could accommodate all the GL 22 devices that are out there.

23 MR. CAMERON: Okay. I think Don is going to add 24 something to that.

25

401 1 MR. COOL: yes. I think maybe one clarification is 2 probably in order. We're going to be using the system to run our 3 registration devices that Larry was just talking about. We're 4 actually going to house all of the information that previously was 5 in the General License Data Base, so all of the things even that are 6 not subject to registration are going to be resident. We just won't 7 be pulling up those files.

8 And we've tried to construct it in such a way that we 9 can add considerable additional numbers of licensees and number of 10 devices. We've actually tried to size it based on our understanding 11 of the national level that's out there, if we wanted to go there, so 12 we wouldn't have to go back and modify the system. Theoretically, 13 there's very little you'd have to do in terms of fields and things 14 to include other sorts of activities if the state wished to pick it 15 up and then have additional things in it. That's part of what we 16 would need to talk about.

17 But conceptually we'd want the exact same kind of 18 pieces, and it would be a matter of how the pieces were segregated 19 within the data bases. And data bases are deliberately designed to 20 be able to parse them out -- separate out different things, cull out 21 sets that you want to have. So I think that can be something that 22 could be fairly easily -- put that in quotes from somebody who 23 doesn't know.

24 MR. CAMERON: Okay. Let's take the gentleman in the 25 audience here, and then we'll go back to -- Richard. Go ahead.

402 1 MR. RATLIFF: I think one of the problems we have in my 2 staff is that it's another national system that this group didn't 3 get involved in what would go into it. I think it's fine if NRC 4 uses it, but if it's good for GL, it's good for specifically 5 licensed gauges. We've had just as many of them show up at scrap 6 yards. And I think the bottom line that maybe we haven't got across 7 yet to NRC is that the states have real diminishing resources.

8 As Pete put in his discussion, we had to cut out certain 9 of the data in our GLA program just because of staff. We're going 10 to be cutting more and more. We have to do our basic radiation 11 programs. And so this is a luxury type thing, and if we can track 12 them in our state, that's really our bottom line.

13 MR. CAMERON: Okay. Thanks, Richard.

14 Yes, sir?

15 MR. DUNN: Wes Dunn, International Isotopes.

16 Luckily for you, Richard hit some of my major points.

17 It seems for the last several years this has been a solution in 18 search of a problem. The only base line coming from this was we're 19 starting to get problems with the scrap metal and steel mills, which 20 were just the large curie gauges. And unlike Aubrey, I looked at 21 the numbers and said -- we both came to the conclusion they seemed a 22 little bit strange, but I thought you had the units wrong. I 23 thought you meant curies, not millicuries. Then you're dealing with 24 health hazard.

25

403 1 When you're dealing with these small sources, where's 2 the health hazard? If there is a health hazard, then to reiterate 3 what Mel said, we've got a flawed system in GLs that maybe the whole 4 system needs to be thrown out. To quote my old patriot, Floyd 5 Hameter, should we maybe just exempt sources and specifically 6 license sources? We shouldn't be putting more work into GLs than 7 we're putting in specific license.

8 MR. CAMERON: Okay. Thanks for putting a little bit of 9 finer point on what Mel was saying.

10 Any response to that comment from anybody? Yes, Pete?

11 MR. MYERS: In the working group that Aubrey and I sat 12 on in July up at Rockville, that was an issue that surfaced. It 13 sounds like it's a repetitive issue that comes up from time to time.

14 And we were told that the NRC apparently in the process of 15 developing what they're doing now offered that to the Commission as 16 an option, to just do away with the GL program, and the Commission 17 said, No. We don't want to do that.

18 Is that right or wrong?

19 MR. CAMERON: Fritz or Don?

20 MR. COOL: I think the answer is yes and sort of. We're 21 actually trying to pursue maybe a little bit of a deliberative 22 process. Rather than jumping all the way into the hundred foot 23 depth, the Commission wanted to pursue this in more or less a risk 24 confronted approach: peel the first layer off, see how that worked, 25 get the systems in place. The understanding, I believe, has been

404 1 that additional things could and would be looked at when we saw how 2 this system was working, how the resources were playing out. And 3 that applies not only moving on down through the GLs, because there 4 are a number of us who sort of wonder about, Well, if it's good for 5 this set, what's the conceptual difference? If we can run it cheap 6 enough, why not run it this way because the whole issue of 7 accountability remains.

8 But also looking up, as the point was made earlier, what 9 about some of the stuff that's currently specifically licensed now, 10 because some of that doesn't make any different sense and the issues 11 with regard to accountability being the principal concerns are 12 similar. One of the things I think we do intend to look at, I just 13 can't give you a date and time certain, is to potentially rerack 14 some of those down so that we have an appropriate set of controls.

15 But first I have to figure out if I can run it for the price I think 16 will actually be effective.

17 MR. CAMERON: Okay. Thank you, Don.

18 I don't see any comments now and I guess I would like to 19 thank our panel and thank Fritz for his double duty. Thank you for 20 taking the time.

21 There is going to be sign up sheets for people who need 22 shuttles to the airport this afternoon. They'll be out there, so if 23 you have a particular time you need tomorrow -- and I'm going to ask 24 our leaders -- two o'clock or an hour an -- what do you think, two 25 o'clock?

405 1 Okay. We'll start back at two o'clock, and we have 2 about seven or eight, I think, unrelated presentations to move 3 through.

4 [Whereupon, at 12:40 p.m., the meeting was recessed, to 5 reconvene at 2:00 p.m., this same day, Thursday, September 9, 1999.]

6 7

8 9

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

406 1 A F T E R N O O N S E S S I O N 2 [2:00 p.m.]

3 MR. CAMERON: Welcome back from lunch, everybody. And 4 we're going to be starting to address a number of disparate and 5 hopefully interesting issues. And when we get to the 3:15 break 6 time, we're going to sort of caucus and see if we should move one of 7 the presentations from later on this afternoon to tomorrow morning 8 to give you more time and to try to make up some time. But we'll 9 see where we are when we get to the break. Some of these issues may 10 have broad interest; some of them may have narrow interest.

11 But our first presentation is going to be by Roland 12 Fletcher from Maryland: Real World Difficulties in Decommissioning 13 to Unrestricted Levels. And then we'll go out to you for questions 14 and comments.

15 Roland?

16 MR. FLETCHER: Thanks, Chip.

17 One thing that maybe we have overlooked or ignored or 18 haven't paid much attention to is with all of the fanfare about Y2K, 19 today happens to be September 9, 1999, where we're supposed to get a 20 preview of the difficulties of 01/01/00. And so far, I don't think 21 anything's happened, so maybe that is the preview.

22 What I want to talk about is, as many of you who have 23 heard these presentations before, it's kind of a continuous 24 adventure, if you will, and like all great adventures, there has to 25 be a certain amount of adversarial relationship. I mean, what would

407 1 Ian Fleming's James Bond, the original, have done without Ernst 2 Stavrou Blaufeldt? Of course, nowadays they've come up with other 3 people. But what would Luke Skywalker have done without Darth 4 Vader, who not only has gone to his maker, but he's been reborn and 5 will start all over again.

6 And of course the NRC has the EPA, that relationship.

7 And so in Maryland we have Neutron Products, Incorporated, NPI. And 8 it has been something that I've been a part of for the last 13 9 years. But just to give you a brief overview -- so let's see. I 10 want to give you a brief history in case you haven't been keeping 11 up.

12 Now, you know this organization. It existed a long time 13 ago. However, when I brought this up to the NRC recently, they took 14 the option of disavowing any knowledge of anything done by any 15 organization that predated them, kind of the way they've done the 16 licensing of previously -- the clean up of previously licensed 17 sites.

18 Now, while the ink was still wet on the application, 19 this facility started to make changes. Now, that should have been a 20 clue. But this was done before we became an Agreement State, and a 21 lot of things that weren't in the original license suddenly got 22 added as amendments. Included in this was the hot cell 23 construction. That's going to be important as we progress, because 24 that's one of the areas that's going to need to be cleaned up.

25

408 1 Then there were worker overexposures, and the RSO 2 resigned. Now, all of these things happened within a two year 3 period of their initial application, but see, Maryland was busy 4 trying to become an Agreement State. And I know you know something 5 about that. When you've got your head down focused on the paper to 6 make sure you've got everything right, maybe you're not looking 7 around to see all that's going on at this facility.

8 So what happens? We became an Agreement State in 1970.

9 We actually started in '71. Then this facility had a pool leak. It 10 went into Chapter -- I jumped a few -- if I put everything up here, 11 that would be all of my presentation. So I jumped ahead a few 12 years.

13 In '86 there was a Chapter 11, which kind of kept the 14 creditors off and some of the regulatory actions off. We had shut 15 downs in '88 and '89 because of loss of control of contamination.

16 We were one of those states we talked about getting licenses out 17 quick. Well, this is one of those licenses where every 18 correspondence included about 50 to 100 questions and took as long 19 to be responded to as it did to review. So each year there was an 20 annual update in the status of the license application. This was 21 the renewal from Hell, but we were given a directive that we would 22 issue a license and in 1996 it was issued. However, it was 23 challenged, of course.

24 And last week, before coming to this meeting, after the 25 challenge was overturned by a judge, we finally issued that license.

409 1 So in three years we finally issued it. But in the meantime, the 2 actual issuance is almost meaningless, because of the next action.

3 We are in the process of pursuing an injunction to have 4 the facility, at least one of the licenses there, totally shut down.

5 Now, the difficulty in dealing with all of the 6 ramifications of a potential shut down is, first of all, there are 7 four licenses there, three of which fell under the criteria for 8 financial surety and a decommissioning plan. Two of those, the 9 Department and our AG's have decided, meet the criteria for meeting 10 the regulations. These are both irradiators and their financial 11 obligation was only 75,000 each. Believe it or not, there's still 12 some glitches there, but we're not pursuing that license.

13 The one we're pursuing is the manufacturer's license.

14 That's where the hot cell is, the limited access area. This is the 15 source of radioactive contamination that we feel is occurring.

16 Also, when you saw where the main pool was leaking, all of these 17 things go togther. So we envision a substantial cleanup.

18 Now, please don't let me give you the impression that 19 the owners of this facility aren't clever, extremely clever, and so 20 are their attorneys. So they got a hold of Part 20 and read this 21 criteria for license termination under restricted release, and they 22 decided that that would work, in their minds, for them meeting state 23 requirements. Well, as most of you know, we are not yet -- we have 24 not yet hit the three year deadline for incorporation, so we 25 haven't -- that's not a part of Maryland regulations.

410 1 But the other difficulty here for this particular 2 facility is that as you read down the criteria, they meet none of 3 them, and therefore, even if we had these laws on the books, they 4 wouldn't meet any of them. But it does bring -- see, part of the 5 difficulty -- one of the first real world difficulties is what you 6 and I understand, judges, lawyers, and citizens don't. And when a 7 plausible argument is presented to a legal person -- sorry, Chip --

8 regardless of the science involved, it is still a plausible 9 argument.

10 And we are right now at something of a crossroad because 11 we're being encouraged to fast track incorporation of these 12 regulations just so we can have the criteria in Maryland to turn him 13 down.

14 Meanwhile, the facility did not meet, as I said, the 15 requirements for financial surety. They passed the deadline. We 16 requested and received a -- well, we asked for a court order and we 17 had a hearing for a temporary injunction to terminate the license or 18 at least put it on possession and storage only. And believe it or 19 not, the judge decided it would have been unfair to shut down the 20 facility under temporary conditions because it looked very much like 21 the state has a strong enough case to win in a permanent injunction.

22 But the facility argued that during the interim, it would be unfair 23 to deprive them of the opportunity to try to satisfy the financial 24 surety requirements. And the judge bought it.

25

411 1 So they are operating outside of the regulations but 2 inside of the court order to try to gain some additional financial 3 worth. That's the way things go.

4 Now, here are some of the realities we're having to deal 5 with. When a large organization like this has functioned for so 6 many years, they develop a reputation. This facility has gone out 7 of its way to develop quite a reputation, not much of it very 8 flattering, particularly in the community in which they reside, 9 which happens to be a residential community. And what they have 10 essentially done has gotten the citizens up in arms about anything 11 they do. Unfortunately, different groups of citizens think 12 differently and oftentimes they don't think through the 13 consequences.

14 For a long time, we had proposed that covering this 15 facility with a cover on its courtyard would prevent some of the 16 particles of Cobalt 60 from getting out. And from 1994 until I 17 guess the last couple of years, that was the solution we were going 18 for. But this -- as I said, this facility has quite a reputation 19 and it got to the point where the citizens just wanted it gone, 20 which is easy to understand but difficult to do in the real world, 21 because in the real world, you have to look at options and 22 consequences.

23 For example, if all court decisions go against the 24 facility and they walk away, you have to be prepared for that 25 alternative. Part of that alternative is talk about someone --

412 1 about cleanup as a Superfund site. But the likelihood of this 2 becoming a complete Superfund site is very low because don't forget, 3 only one license has been affected by this decision. There are two 4 operating, functioning irradiators that are still there, so only a 5 portion of the facility can be cleaned up.

6 Well, the citizens would like to see the whole facility 7 done, and that can't be accomplished. But they also don't want this 8 facility turned into a Superfund site. So if you're starting to see 9 a tightrope that we're walking, that's the exact situation. And the 10 third thing is, we don't want to prejudge or predict what a court 11 might decide to do.

12 There is also the possibility the facility may once 13 again declare bankruptcy. They've done it before and come out of 14 it. They could go back into it. While all of this is going on, one 15 thing I can guarantee you will continue to go up, and that is the 16 cost of the final solution.

17 These are some of the things I've already talked about, 18 but some of the letters we received from various members of the 19 community are quite interesting. One I want to highlight in 20 particular. We were more or less told that we should exercise more 21 muscular enforcement. And this is with the court. They want us to 22 more or less go in and tell the legal system what they should be 23 doing in response to this facility. I don't think that that's the 24 option that we're going to select, but it's one of the 25

413 1 recommendations that we've received. And we don't have a date set 2 for the permanent injunction hearing.

3 So, what are we going to do? Well, first of all, I'd 4 like to find a cure to attorney roulette, because while all of this 5 has been going on, we've been through eight attorneys. And each 6 time you have to reeducate -- the amount of documentation with 7 regard to this one licensee would fill about half of this room, just 8 the legal documentation. So each time a new attorney comes on 9 board, you've got to reeducate them on what has gone on before.

10 I would like to be able to convince my department that 11 hire -- additional staff to compensate for those who are spending 12 their time in court so that we won't be so far behind in licensing 13 and things like that -- hire is not a bad word. It is something 14 that you can do on occasion to deal with a problem. Thankfully, I 15 think they finally listened to us after -- and I must appreciate 16 some comments from my last IMPEP. I think that did the job.

17 Prescriptive license approval -- that's something that 18 we have initiated with this licensee, and based on some of the 19 comments I've heard about the back forth of amendment, that's 20 another option. I heard someone else talk about -- there comes a 21 time when you know what needs to be done and whether or not the 22 facility wants to put that in their application, we may still just 23 have to put it in as a license condition. Just make the decision 24 and give it to them as, This is your license. This is something 25

414 1 that we need to have in it. We've had to do it with this licensee.

2 We see a couple of others that we may have to do that on.

3 These are some of the lessons learned. Nothing happens 4 smoothly -- as smoothly as you'd like. You are not always right 5 when you think you are. And whenever you deal with outside 6 entities, be prepared for 360 degrees of response, because they will 7 change their mind about what you're doing if it doesn't conform to 8 what they think it should be.

9 That's our current status, and I'll probably be doing 10 this again next year. Thank you.

11 MR. CAMERON: Thanks, Roland. That's a classic case of 12 what we might term a difficult licensee. I wonder if anybody else 13 has run into this problem, has any advice for Roland, or would seek 14 any advice from him on trying to deal with this particular type of 15 problem.

16 Anybody?

17 (No response.)

18 MR. CAMERON: Okay. I don't see anybody who has any 19 questions or comment on this, and you'll have a chance next year 20 because you'll be back with the same sad story. Right, Roland?

21 Okay. We're going to go to another unique situation, 22 and this is license transfer process for Sherwood Uranium Mill.

23 Terry Frazee from the State of Washington is going to do that for 24 us.

25

415 1 MR. FRAZEE: First of all, I need to extend my apologies 2 for Gary and John Erickson, who were not able to attend this 3 meeting. Our other uranium mill is issuing a press release today.

4 It should have been released about an hour ago. And they were 5 required to stay back at home to take care of that. Gary also sent 6 me with an extra set of slides, recognizing that this is sort of a 7 narrow focus and not too many people are going to be interested in 8 the uranium mill issue. I have some slides of the Trojan Reactor 9 being carted up the river and buried.

10 I'm going to sit down because since it's not my 11 presentation, I have lots of notes to read on it.

12 Okay. Western Nuclear was our second uranium mill in 13 Washington. It was licensed in 1978 and operated continuously until 14 1982, and was then in a standby mode until 1991. The buildings 15 themselves were demolished. The mill buildings were demolished in 16 1993 and the closure plan was submitted to us in basically late 1994 17 and approved by the Department about a year later. The final 18 reclamation, which is what you're seeing here, was completed in the 19 fall of 1996. And currently, they're in the monitoring and 20 stabilization of the cover phase.

21 Now, because this mill -- the mine and the adjacent mill 22 were located on Indian reservation, the responsibility for this site 23 is going to revert to DOE with NRC having a role in being 24 responsible for reviewing and approving the long-term stabilization 25

416 1 plan. And that will take affect once the license is terminated, 2 which hasn't occurred yet.

3 Now, because of NRC's role, they were invited early on 4 to participate in the review and development process for the 5 closure, and that was about 1994 or 1995. The NRC declined to 6 actively participate and obviously didn't conduct a detailed review 7 of the plant at that point. They did, however, comment on the 8 conceptual design and they told us basically, It's okay as long as 9 it meets the performance specifications in the regulations. So 10 therefore, we were on our own.

11 The Department of Health followed NRC guidance as far as 12 radon attenuation, groundwater protection, report preparation, 13 erosion protection, conducting rad surveys, and we used Title 1 as 14 guidance for writing a technical evaluation report for the uranium 15 mill. And this was all in 1996, '97, '98, going through years and 16 years of getting this place ready to go.

17 When 1999 comes around and it's like the light goes off 18 and NRC decides to send out a surface-water hydrologist to conduct 19 its first post-reclamation audit of the site, we -- he reviewed the 20 rock placement, gradation, and durability and also the executive 21 summary of the technical evaluation report that we had written, but 22 apparently had not reviewed any of the supporting documentation.

23 And, of course, that was the closure plan itself: design specs, 24 as-built reports, the monitoring stabilization plan, and so forth.

25

417 1 There are a number of things that are unique about this 2 closure. We decided to go with a thick homogenous cover rather than 3 compacted clay, to use vegetation rather than riprap to hold down 4 the cover and to rely on native plants for evapo-transpiration 5 purposes. And we also did not dewater the tailings.

6 You've been looking at this aerial view for a long time, 7 and it's like -- Gary thinks you can see this from the moon. It's 8 kind of a blight on the surface of the earth, here.

9 Interesting story to relate to you, Gary and his staff 10 were out showing the members of the tribe around the site and 11 walking over the surface of this thing and showing them -- from 12 Gary's perspective it's, Hey, this is a really great job we've done 13 here and so forth, with nice, clean, smooth, clear, nothing out 14 there to confound anything. And the medicine man was also with Gary 15 and his staff, and he's taking it all in, he's looking around, 16 looking down, looking up. And Gary is just sure he's about to give 17 him his blessing on, This is a really great job.

18 Instead, he looks at Gary and he says, This is not 19 right. This is sterile. There are no ants. There are no flowers.

20 There's no bees, no deer, no trees. It's just -- he's going through 21 this litany of things that just are not there. And there's no 22 debris; the things that would be needed really to establish some 23 living things back into the area. And so Gary's going to end up 24 having them bring some more junk in just to sort of provide that 25 micro-environment for critters.

418 1 Now, this is what the Indians want. They don't want the 2 sterile environment. They want biodiversity.

3 We're going back to the technical part of it. There are 4 several things that were unique about this and the fact is a thick, 5 homogenous layer -- is because in this area the climax for us is 6 Ponderosa Pine. And the roots will penetrate quite a ways, and they 7 would penetrate a clay barrier, is what the belief is. And that 8 would -- is this had been the traditional compacted clay type 9 narrow, small barrier, the roots would have penetrated. It would 10 have allowed for excess radon emanation and so forth.

11 In addition, if you've ever seen a wind-blown evergreen, 12 the root system is wide, not really deep, but it is wide and when 13 they fall over, they sort of -- and up comes a big chunk of turf and 14 you have a nice little hole. And that, even though it's relatively 15 shallow, that probably would compromise any clay barrier, had we 16 used that approach. And the other factor with the homogenous thick 17 layer -- 13-1/2 feet as opposed to six feet of compacted clay --

18 that's also basically a self healing sort of barrier. Any wound 19 like that would be basically filled in after some point in time, 20 just because of surface movement.

21 The vegetation is going to come anyway. If you look at 22 some of the other DOE sites and mill sites, you give it long enough, 23 the vegetation's going to come. So we pre-plan for vegetation and 24 that's going to help with the long-term maintenance. If you plant 25 the vegetation it's going to be there. You really don't want to

419 1 tear it out, as you do have to in other places. And it also 2 provides the desired biodiversity that the Indians were concerned 3 about. Also, along with the low lying vegetation, the trees are 4 also going to add to the evapo-transpiration and help prevent rain 5 water from penetrating the cover.

6 And of course, the cover and the fact that we're not 7 dewatering the tailings was based on a geochemistry issue and 8 basically it was not practical to pump the tailings dry; too many 9 slimes in it. It just wouldn't pump fast enough to make it dry.

10 And there was also a concern that potentially you're introducing 11 oxygen and oxidizing the uranium that's still a little bit there.

12 And if water then were to be reintroduced, you'd have resuspension 13 and mobilization of the uranium, and we didn't want that.

14 A little more about the NRC's reclamation audit -- the 15 inspector was critical of the rock durability placement and 16 gradation, and the major contentious issue was the diversion channel 17 that runs around the site. And starting from the upper -- well, the 18 most left portion is the head waters of the diversion channel, and 19 it runs around to the top of the picture and then around the side.

20 You can see it most clearly on the right side. And that's about a 21 9,000 foot channel, and there is 700,000 square feet of rock surface 22 in there. It's mostly three to six inch rock, but where there are 23 confluences, where there's channels that are draining from the 24 surrounding land, there's about 15 inch rock that's in place.

25

420 1 NRC's inspection -- they noted that there's about 700 2 square feet where the rock didn't meet what were considered the 3 placement and gradation criteria. That's less than one-tenth of 1 4 percent of the entire area. And we did not believe that to be a 5 failure per se, although that's the way NRC is wording it.

6 Larger picture of the diversion channel -- obviously, 7 there's your perspective. This is in the three to six inch rock 8 lane. Farther in the background is the final picture. This is the 9 largest -- of the 700 square feet, there was a ten by 15 foot 10 patch -- and that's it right there -- that was not right. And of 11 course, this will be filled in. Everything else is in the two to 12 five foot square foot, really small holes. Other than this one --

13 this was the biggest -- there was just these few sites, and that's 14 the biggest.

15 Another thing that he wanted me to point out was that 16 this particular area had to be blasted out in order to put the 17 diversion channel there anyway, so we're talking bedrock below this, 18 so erosion is really not a concern at this point. In fact, 80 19 percent of the whole diversion channel is -- the underlying strata 20 is monzonite, rock -- bedrock.

21 Anyway, all this stuff will be repaired before we turn 22 loose of the site. And we've also conducted a number of inspections 23 this summer, and we also have lots of questions about erosion 24 issues. But we don't agree with NRC's assessment of the channel as 25 having failed.

421 1 Okay. So there were three recommendations that I'll 2 wrap up with here. If NRC intends to be involved in a reclamation 3 project, it needs to begin its involvement early on and should 4 remain involved throughout the project, rather than waiting until 5 after the project is completed. And secondly, if the NRC is going 6 to be involved, then it needs to review all the technical 7 information which has been provided in support of the project and 8 should also be involved in the approvals and should be an equally 9 responsible party. And finally, it should assign qualified staff to 10 each aspect of the review process.

11 We have engaged this list of experts in reviewing the 12 site and we believe it covers all the bases, and what we're saying 13 is that we need to make sure that if you're going to -- if NRC comes 14 out and reviews, they need to have pretty much the same kind of line 15 up in order to review it. Anyway -- so, that's it for that part and 16 hopefully, you won't have any questions because we're running out of 17 time, if nothing else.

18 There's a few more pictures here, but they're very 19 brief. As I'm sure you probably all know, the Trojan reactor was 20 taken out of commission, and the reactor -- actually the reactor 21 vessel was removed intact, without fuel, of course -- was removed 22 intact and shipped off to -- barged off to Hanford [phonetic] to its 23 disposal.

24 A couple of tugs had to accompany the barge; not that it 25 required two tugs but just for safety purposes. It was barged about

422 1 270 miles up the Columbia River, and this is at Port of Pasco, where 2 it's being -- or north of the Port of Pasco, where it's being run 3 into a slip. And then the barge was actually flooded in order to 4 get it down on the river bottom, and then a couple of big trucks --

5 there are two of these: one in front and one in the aft. This 6 one's The Beast. The other one, of course, is Beauty. So Beauty 7 and The Beast were the two huge tractor-trailer things to haul this 8 cross-country to the waste site.

9 And so here it is in it's nice little carrier. It looks 10 like a big dumb bell, but it's -- a little more than necessary.

11 Those two big donut things on either end are impact limiters, 12 designed to cushion it if it rolls off, I guess. And here's -- I 13 think this is the final shot. This is now down into the trench, and 14 the impact limiters have been taken off and it's just sort of 15 sitting there ready to be filled up. And it sits all by itself in 16 this huge trench.

17 And that was it. Okay.

18 MR. CAMERON: I think we do have one question, at least 19 on the Sherwood issue.

20 And, Ed, do you want to --

21 MR. BAILEY: Yes.

22 MR. CAMERON: All right.

23 MR. BAILEY: Since that was on Indian land, why wasn't 24 it NRC's responsibility totally?

25

423 1 MR. FRAZEE: The State of Washington was asked by either 2 the tribe or BIA at the time -- I don't remember the details -- but 3 we ended up with the responsibility, even though it's --both the 4 mine and the mill were on Indian land. I don't know. If anyone --

5 Paul, do you know the history there?

6 MR. LOHAUS: Paul Lohaus, NRC. I believe that at the 7 time that decision was reached, the -- I guess the legal 8 interpretation relative to jurisdiction was that if it was a private 9 concern that was establishing a facility on Indian land, that that 10 facility would be subject to Agreement State jurisdiction. At the 11 same time, if it was an Indian nation that was the applicant, then 12 the license would be issued by NRC as opposed to the Agreement 13 State.

14 Recently, the question of jurisdiction relative to 15 activities that take place on Indian nations has been raised I think 16 in a number of cases regarding reciprocity, and it is an issue that 17 is being further examined primarily from a legal jurisdictional 18 standpoint. And based on that review, there may be additional 19 guidance and possibly some changes relative to how reviewing and 20 dealing with Indian -- I guess the question of whether it's 21 Agreement State or NRC jurisdiction on Indian lands -- but until 22 that's completed, the Commission has an opportunity to look at that.

23 I'm not certain exactly where that's going to come out, but it is 24 under reconsideration.

25

424 1 But I think in the earlier guidance, it was very clearly 2 stated that if it was a private concern similar to Western Nuclear 3 and the activity was taking place on an Indian reservation, the 4 Agreement State very clearly had jurisdiction under that 5 interpretation.

6 While I have the mike, I did want to respond to a couple 7 of points that Terry and Gary raised, and I think there are some 8 very good points that are going to require some further 9 consideration and discussion. And as Terry noted, this particular 10 area is relatively narrow. There's only a few states that have the 11 uranium mill authority. And also with UMTRCA, the Uranium Mill 12 Trailings Radiation Control Act, there are some rather unique 13 aspects that are not shared relative to the other parts of the 14 Agreement State program and authority. And in particular, under 15 UMTRCA, Congress made it very clear that in addition to the state 16 determination relative to a site being closed in accordance with 17 appropriate standards and requirements, that NRC is also to make 18 that determination. That's one aspect.

19 The second aspect is that there's an option that the 20 state has relative to long-term custodial ownership of the property.

21 The state has the option of retaining ownership or transferring 22 ownership to the federal government, and I think in most cases the 23 expectation is the state will transfer ownership to the federal 24 government. And that's the case with respect to the Sherwood mill.

25

425 1 So a second part of this thing, in addition to the 2 independent determination that NRC would make that site's been 3 closed in accordance with appropriate requirements, there's also the 4 second aspect relating to land transfer and at the time that 5 transfer takes place, what's necessary is that an acceptable 6 long-term surveillance plan has to be prepared and submitted by the 7 custodial agency, in this case either the state or the federal 8 government. And NRC would issue a general license to that custodial 9 agency based on an acceptable long-term surveillance plan to cover 10 the long-term control and monitoring. Basically, it's going to be 11 carried on in perpetuity.

12 The issues that Terry raises appear to be, in terms of 13 referring to the visit that our hydrologist made, as activities that 14 were related to our concurrence determination that all standards and 15 requirements have been met. In point of fact, that visit was done 16 in connection with our activities to address the long-term 17 surveillance plan.

18 In other words, for a site that's under NRC 19 jurisdiction, we have good background and understanding of the 20 closure, the plan, et cetera. In the case of an Agreement State 21 site, we're not necessarily going to have that background and 22 understanding. And that's where I think -- the point that's raised 23 here is how does NRC maintain or have that understanding when we 24 don't really have the direct jurisdiction until you're to the point 25

426 1 of license termination? So there is an issue relative to, how do we 2 work and coordinate during that time frame?

3 But in this case, the visit that was made was really in 4 connection with the long-term surveillance plan part of our 5 responsibility, not with respect to the concurrence determination.

6 And I think as you're all aware, we do not have -- these are 7 decisions that were reached a long time ago. We're not going to do 8 de novo reviews or independent reviews of state licensing actions, 9 including uranium mill actions.

10 And recently, in response to this area, we did develop a 11 procedure -- it's a procedure within my office which addresses how 12 we will handle the site closure determination that we're required to 13 make. And basically, it's got two parts to it.

14 One is we would like some information from the state in 15 the form of a -- we may want to call it a closure report which would 16 document the state's review process that this site has been closed 17 in accordance with state requirements which are equivalent or 18 compatible with NRC requirements. And the second is, we have 19 confidence in that determination on the basis of our IMPEP program 20 reviews.

21 In other words, we're not going to do an independent 22 review of the closure plan, the implementation of that plan, the 23 design reviews, et cetera. We're going to have confidence, based on 24 the program reviews, that what the state does in its determinations 25 that state requirements are met, that we have confidence that's

427 1 comparable to what NRC would do. So we're not going to do a 2 detailed review through that process. But the issue, how do we 3 maintain a sufficient base of information such that when the 4 long-term surveillance plan is submitted we're in a position to 5 understand that plan will in fact work for that site and is 6 compatible with the closure decisions that were reached by the 7 state.

8 So I think this is the first one, conventional mill, 9 that we're faced with, and I wanted to spend a few minutes to talk 10 further about this because those of you that have mill programs --

11 this is an area that, given the experience here, there's some 12 lessons learned and some areas that we can have some further dialog 13 on, and I think have a better process that will serve all of us 14 better in the future.

15 I'd also like to note, though, that we have been I think 16 successful in addressing in situ facilities. There are seven 17 facilities in Texas where we have applied our procedure for the NRC 18 determination that the facilities were closed in accordance with 19 appropriate requirements, and those facilities are in the process of 20 final completion. And we provided Richard with the NRC 21 determination. There's one more that we have that will hopefully be 22 closed out shortly. So I think we also have some base of experience 23 in applying the procedure and being able to make the determination 24 that the actions that were taken by the state were in fact done, and 25 we can make -- NRC can in fact make its concurrence determination.

428 1 So I think we have some base of experience there as 2 well.

3 I'd like to sere if there's any additional thoughts you 4 may have, Terry or any others that may have mill programs. But I 5 think this is a unique area to the mill states and does have some, 6 as I said, some rather unique aspects because of the UMTRCA 7 legislation.

8 MR. BAILEY: Can I follow on to that? You mentioned 9 that the state now has ownership of it, and therefore it's not 10 Indian lands anymore, is it?

11 MR. LOHAUS: Well --

12 MR. BAILEY: You don't have ownership of it.

13 MR. LOHAUS: In this case, you're correct, I misspoke 14 when I said state or federal. In this case, given that it's an 15 Indian reservation, there's only one option and that is federal. I 16 don't think the state would have the option in this case.

17 Thank you. That's correct.

18 MR. CAMERON: And I think you clarified the major 19 question that people might have had, which is not the tribal 20 jurisdiction question but why the NRC got involved in it again. And 21 it's peculiar to the uranium mill situations: either the 22 concurrence or the long-term care situation. That's what I think 23 people were wondering about.

24 MR. BAILEY: I guess now that we're talking about 25 11(e)(2) material, in some of those conventional mills, that

429 1 11(e)(2) material was generated before 1978 and I'm hearing that 2 you're going to regulate it. Is not this policy inconsistent with 3 your other determination on 11(e)(2) material that you don't have 4 authority to regulate it?

5 MR. CAMERON: Is that a subject that's on the agenda for 6 tomorrow morning?

7 VOICE: This afternoon.

8 MR. CAMERON: Oh, for this afternoon? Okay. Well, it's 9 later at any rate. Do you want to -- why don't we address that when 10 we do get to FUSRAP?

11 MR. BAILEY: Okay.

12 MR. CAMERON: I think that's the best place to do it.

13 MR. BAILEY: Okay.

14 MR. CAMERON: Okay. Any other -- Steve, you have a 15 comment?

16 MR. COLLINS: Paul, have you or will you make available 17 that internal written procedure that you have on your process for 18 closure?

19 MR. LOHAUS: Yes. It's available on our website.

20 MR. COLLINS: Okay.

21 MR. LOHAUS: If I remember correctly -- maybe Dennis can 22 make sure I have the right number -- but I believe it's --

23 MR. COLLINS: I know the last time I talked to you about 24 it, you spouted off what your procedure was but you didn't mention 25

430 1 it being in writing at the time I talked to you about it, months and 2 months ago.

3 MR. LOHAUS: I believe it is on our website.

4 MR. COLLINS: We're interested in having a copy.

5 MR. LOHAUS: Okay. Will do. It's SA 900.

6 MR. STURZ: Fritz Sturz, NRC. Finally, something I'm a 7 little familiar with. I'd like to just make a comment about the 8 shipment of the reactor vessel up the Columbia River.

9 This morning, Seth Coplan had a presentation about 10 risk-informed performance-based regulation. Look into this, but the 11 approval of that reactor as a transportation package was a 12 significant piece of risk-informed licensing that the NRC did, and 13 there was no way -- I think it would have been cost prohibitive to 14 have that Trojan reactor vessel meet the Part 71 requirements for a 15 transportation package. And there was a lot of work done on risk 16 assessment and what the alternatives would be to cutting up that 17 reactor and what the exposures would be to workers to cut that up to 18 fit it into a qualified package. And they did an evaluation of the 19 package under specific transportation route conditions: looked at 20 what could happen and what the consequences were.

21 So just to point out -- if you want to look into it, 22 that's a significant piece of risk-informed [indiscernible].

23 MR. CAMERON: Okay, thanks.

24 Kathy Allen is with us now to talk about streamlining 25 license termination, and I'm going to turn it over to her. And if

431 1 you want me to keep track of anything, I'll be glad to do it on the 2 flip chart for you.

3 MS. ALLEN: Okay. I'm going to stand so I can talk 4 fast. We can catch up on time. If I talk too fast, raise your 5 hand. I'm not looking up.

6 How many people perform verification closeout surveys --

7 states? I was hoping for 100 percent. See, we all agree. Isn't 8 that nice?

9 When you look at the closeout surveys, do you exempt --

10 how many people survey everybody, every licensee? Anybody do 11 that -- do confirmatory closeout? Didn't think so. Do most people 12 exempt small quantities of material of short half-life material from 13 closeout surveys? Hands up. Very nice. I'm going through this so 14 you can see what other people do, because I think we might find some 15 differences, or if we find out that we're all the same, then 31 16 flavors. We all agree.

17 How many people perform closeout surveys for people who 18 possessed only sealed sources? Okay. Well, pull all those people 19 that leaked or any incidents off the table. Very good point, 20 though. How many performed closeout surveys of people who possess 21 loose material only? Is that pretty much your -- how many people 22 actually use a criteria for loose material -- those are the ones you 23 go out and do surveys of? Is it typically longer half-life 24 materials and only certain types of uses? So you do have a graded 25

432 1 approach to what you're going to do closeout surveys on? That's 2 pretty much what we suspected.

3 Now, when somebody says that they're terminating, do 4 they have to tell you what they did with their sealed source? Get 5 rid of it, who they sent it to? Do you typically -- I'm assuming 6 everybody gets that information. How many people accept just that 7 information and then close it out versus how many people then follow 8 up with the recipient to verify that they received it? So how many 9 people just accept what the licensee says where they shipped their 10 sealed sources to? Now, the show of hands for those that actually 11 call the recipient to verify that they received it? Now, we all 12 find our programs are still adequate though. Right? Just checking.

13 I want to look at financial assurance. How many 14 licensees -- when a licensee establishes financial assurance, do you 15 draw -- I believe in NRC land a licensee can draw down on the surety 16 or the assurance that's been posted, to use that money to clean up, 17 versus some states that actually say, No. Your financial surety 18 stays locked in, and once you demonstrate to me that you've cleaned 19 it up, then we'll allow you to draw down.

20 So I'd like to see a show of hands that allow licensees 21 to access their surety -- or financial assurance arrangements prior 22 to cleaning up.

23 VOICE: Prior to cleaning up?

24 MS. ALLEN: Prior to cleaning up.

25 VOICE: With an approved decommissioning --

433 1 MS. ALLEN: Sure. With an approved decommissioning plan 2 prior to cleaning up. How many people just allow a decrease in 3 financial assurance only after they've demonstrated they've cleaned 4 up that portion?

5 (Pause.)

6 MS. ALLEN: And I have a lot of confused looks on faces.

7 For those of you that saw other hands go up, if you have questions 8 about how other people run their programs -- we don't have time to 9 get into the discussion sections, but some of the issues that I 10 wanted to raise were how detailed do you get in terminations? How 11 much information do you ask from these people? Do we find ourselves 12 spending almost as much time terminating licenses as we do issuing 13 licenses in the first place, or are they pretty much 14 straightforward: have they got rid of this stuff? For most 15 terminations it's pretty straightforward. Right, pretty much?

16 (Pause.)

17 MS. ALLEN: Okay. Well, we wanted to get -- I wanted to 18 get into more stuff, but actually for the sake of brevity, I think 19 I'm just going to let you guys rest. And I think I'll bring a 20 couple of other issues that stem from this up at the business 21 meeting.

22 Thanks.

23 MR. CAMERON: Okay. Thanks, Kathy.

24 Jake is going to talk to us about the Colorado petition 25 at this time -- the Colorado GL petition.

434 1 MR. JACOBI: Just briefly as an introduction, what I'm 2 going to talk about is that as we've all accepted, Part 20 has been 3 based upon national and international guidance and it's used to set 4 limits for exposures and release and the mechanism for the safe use 5 of radioactive materials. And Part 19 has been established to 6 provide a right for workers to know what they're working with, and 7 we put the two together and we say that an informed, knowledgeable 8 workforce is necessary to protect radiation exposures and to keep 9 everybody healthy and safe.

10 So we have set this mechanism up that wants to apply to 11 almost all of our licenses. And unfortunately, possibly because at 12 one time the NRC or Atomic Energy Commission in their great wisdom 13 decided that source material general licensees couldn't be a 14 problem. They have eliminated the Part 20 and Part 19 requirements.

15 And to try and demonstrate some of the problems with this, I thought 16 I'd walk you through some of Colorado's experiences.

17 Now, our experience -- the light bulb went on last 18 January when our great working public-private partnership that we 19 all have -- the gate monitors at landfills and the state radiation 20 control program got together again. And we set off an alarm. And 21 it happened to have been about 4.9 mR per hour at the surface of a 22 dumpster.

23 We originally thought that it was a sealed source 24 because of the other material that was in this dumpster. It looked 25 like it was a pretty narrow beam coming out, so we found the sealed

435 1 source. We're okay. And the owner of that dumpster hired somebody 2 to go through it and as they found contaminated material, they put 3 it in one dumpster. When they found clean material they put it in a 4 second dumpster. And finally we started finding everything 5 contaminated, and we found some garbage bags.

6 Inside those garbage bags were some vacuum cleaner bags.

7 And these vacuum cleaner bags were measuring 11 mR per hour. And 8 this was after about a third of them had spilled and spread out 9 through the rest of the dumpster. So needless to say, we had quite 10 a large system of contamination.

11 Well, being smart regulators that we were, we decided, 12 Well, if it got in the dumpster, it's got to have come from 13 somewhere. So we went back and found out where this dumpster came 14 from, and it was the result of a remodeling project. Now, 15 unfortunately, by the time the people who filled the dumpster 16 started remodeling, the building had already been gutted. The 17 previous tenant was required to clean up everything they had put 18 into it, and this included walls, included ceiling tiles, and just 19 about anything else that wasn't fastened down.

20 The only thing that was left was the roof, the floor 21 tiles, and a couple of toilets. And that's what had been taken 22 apart that went to the dumpster and set off the alarm. Because not 23 all facilities in Colorado have portable monitors, we're really not 24 quite sure what else went where.

25

436 1 But anyway, we went back to this facility to see if 2 there was a problem and we found contamination clearly around the 3 inside and the outside of the building. We ran NRC's D and D code 4 and we found out that the peak annual exposure projected was some 28 5 times what the NRC had for unrestricted release. And as I go 6 through, remember all of this is by a source material general 7 licensee that is exempt from Part 20 regulations.

8 Exposure levels around parts of the building generally 9 ran about 100 mR per hour. A 30 gallon drum of waste -- this is 10 only critical because we took the philosophy, while you can have 15 11 pounds of source material under a general licensee, if you put one 12 ounce of dirt on top of that 15 pounds, you now have more than 15 13 pounds in your specific license, so we could specifically license 14 their facility. And we had a mop bucket that read 500 counts per 15 minute in it, and this gave us a clue of why the building was so 16 contaminated.

17 After this company, who had -- I'll get into what they 18 did in a moment -- every once in a while they would mop down the 19 floor and the contamination went in between the floor tiles and 20 hence, when they dug up the floor tiles we had contaminated under 21 the underlying flooring. A lot of the material looked like it was a 22 powder and so we tried to vacuum it up, but we still were left with 23 about 500 DPM after we tried to vacuum it, and that didn't work.

24 And when you have mop buckets that are contaminated -- you know you 25 empty mop buckets, so we got into the process -- or rather the

437 1 consultant got in the process of digging up sewer lines. And so 2 they moved a bunch of sewer lines that had been on the property.

3 I put a question mark down here on cost. Last I heard 4 about a month ago, the consultant had charged -- I think it was a 5 little over $110,000, and the bid for disposal of this material, 6 EnviroCare, was $250,000. And again, general licensees, they're 7 exempt from any requirements and they don't need financial assurance 8 arrangements. And of course, they always hit the local newspaper --

9 all very nice about keeping the public involved about radioactive 10 contamination.

11 Well, we figured we had this company that created us a 12 problem and we said, Let's go see where they are now. What the 13 company was in our particular case that caused this was a company 14 that coated optical lenses, and they used thorium because it's used 15 for infrared imaging: your night goggles and a lot of military 16 equipment.

17 Briefly, in a nutshell, the way you coat optical lenses 18 is you have a vacuum chamber. You have what's called the boat, and 19 what they call the boat is about four inches long, two inches high 20 and one inch wide. And you fill it with thorium fluoride and you 21 put that boat full of thorium fluoride and lenses in the vacuum 22 chamber. You seal it up. You evacuate it. You vaporize the 23 thorium, and you let it condense back down on top of the lenses. It 24 works very efficiently, but it also condenses down anything and 25 everything else. Well, that's what this company did.

438 1 We found work stations that were over 1 mR per hour when 2 we got there, and based on our knowledge of what we had from vacuum 3 cleaner bags before we figured it's going to reach 5 mR per hour --

4 the process was when they opened up the chamber there would be this 5 little powder left around in the vacuum chamber, and so they got a 6 vacuum cleaner and they vacuumed it out. And the way the facility 7 is set up is in one small area, on one side of the worker there's a 8 work station. On the other side of the worker was the vacuum 9 chamber and in between was the vacuum cleaner bag.

10 So it was constantly being exposed to what's going on, 11 and this 2-1/2 rem per year -- not millirem per year -- was 12 basically said, we'll have an average of between one and five. The 13 average will be 2-1/2. And we say 1,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> per year for working, 14 and so it could be higher than this.

15 We found a storage cabinet where the materials were held 16 reading 1 mR per hour. We had a thorium handling area reading 3 mR 17 per hour. Contaminated sheet metal -- this is another fun story --

18 they lined the inside perimeter of the vacuum chambers with thin 19 aluminum sheet metal to try, I guess, to keep contamination down.

20 When we went to the facility there was all this sheet metal folded 21 up, and it was reading about 1.4 mR per hour lining along the wall.

22 I guess they realized they were in trouble and it would 23 be an expensive cost to get rid of it, so about a month later we get 24 a call from an aluminum recycler that a shipment from Tennessee came 25 back. And so our optical lens company wound up buying another

439 1 $16,000 worth of scrap aluminum. And of course, we had vacuum 2 cleaner bags, and these were only going up to 5 mR per hour.

3 Who cares? No posting. No worker training. We talked 4 to a lot of the workers who said, It's radiation, but we're told 5 it's not harmful. In fact the president of the company sat down 6 with us and bragged before he admitted that he was responsible for 7 all this. He said, I've been to the Oakridge training course and 8 it's generally licensed and it's not a problem. So I'm not sure if 9 that's what they told them in the Oakridge course or that's what he 10 interpreted from it.

11 Well, I don't want to go much into this, but we used 12 general provisions orders and we asked for a specific license. I'm 13 not sure if NRC could have done any of this under its regulations, 14 but we did. And as I've said, we got a little creative because we 15 said, You've got more than 15 pounds of stuff and there's thorium in 16 it, therefore, you've got more than 15 pounds. I'm glad they didn't 17 challenge us on that one.

18 Now, if it was just this one facility, I would say fine.

19 I wouldn't be up here. I wouldn't have suggested that there be a 20 petition to the NRC because I'd say we've got one problem. You 21 don't need to change regulations if you have one problem. But I 22 spent an afternoon -- I found several others. I talked to Rita 23 Aldridge [phonetic], and she mentioned she had a facility in Glen 24 Cove that had a similar problem.

25

440 1 And you might say, Well, why did you call Rita? Well, I 2 found an internet hit from the -- an EPA annual report that talked 3 about a facility in Islip, New York which had not only released 4 thorium down the sewer lines but they also put hazardous material 5 down the line. And I called EPA and I called the county health 6 department. I could never find out how much thorium went down, but 7 EPA reported significant quantities were down the sewer line.

8 There's a second lens coating operation that we found in 9 Colorado. Fortunately, it had just started business and it was 10 doing research and development, so it had only done a couple of 11 hundred lenses. And we were able to get them started on the right 12 track before they got a major problem. The zirconium refacotry 13 powders are kind of interesting. They're used for repairing 14 kilns -- and don't ask me the physics or the mechanics of it -- but 15 it is used, and it contains thorium.

16 I found a note posted on Radsafe from somebody saying, 17 We have -- my client has cement kilns and I thought I'd check the 18 thorium concentrations outside and around these kilns, and it seems 19 that it exceeds the NRC's cleanup criteria. And he asked, Are we 20 exempt from having to clean this up because it was generally 21 licensed? And my response to him, as I read the NRC regulations, 22 Yes, you are exempt. Leave it contaminated and just go about your 23 own way.

24 The other thing I did to see if maybe we have other 25 problems -- and this really also ties into what Greta mentioned

441 1 about evaluating what we exempt for source material -- I did a 2 search. I used two words on EPA's website. I did thorium and I did 3 removal. And there were hundreds of hits. I did not have time to 4 see how many hit in generally licensed verus how many were exempt, 5 but clearly, it indicates that we do have a number of problems.

6 Colorado wasn't alone. And so we thought maybe it's time to do 7 something generically.

8 Now, this is the source of our problem and as you see, 9 40.22(b) says, We exempt general licensees that use source material.

10 And as I said before, perhaps at one time when the Atomic Energy 11 Commission had decided they were going to exempt this, they said, 12 Nobody can possibly get exposed and there can be possibly no 13 problems relating from generally licensed materials that are 14 uranium, thorium. It just can't happen. Well unfortunately, we've 15 learned the hard way.

16 And so you start looking at what do we exempt that we 17 require every other class of licensee to do? We'd ask them to have 18 ALARA programs to limit occupational exposure, embryo exposures, 19 fetal exposures, minor exposures, limit public dose, limit release 20 limits. We'd ask them to survey. We'd ask them to store.

21 Incidentally, these containers, the way our company got them, came 22 in kilogram -- one kilogram containers, DOT labeled two with a 0.2 23 transportation index on them.

24 Again, we exempt them from all posting, procedures for 25 receiving, opening, waste disposal requirements, waste manifests,

442 1 worker training, and postings. We've got a lot of issues that they 2 should be required to do, but we don't. We just have basically 3 ignored it.

4 There's a few other issues, and a lot of what I'm saying 5 relates to the resolution that we'll talk about. But there's other 6 issues besides the resolution an the specific exemption that are 7 related, and I'd like to talk about those. But let me just say that 8 when the petition was written, it was done so that the NRC would be 9 in a hard position to deny that some workers need to limit their 10 dose and some don't. That some licensees are required to post a 11 radiation area and some licensees are not required to post a 12 radiation area. So remember, there was a very narrow focus for the 13 petition, but there are several other issues that we really need to 14 consider.

15 One of the first things we started saying is, What 16 limits do we set for these people who are working there? We 17 thought, Well, occupational exposures make sense because they are 18 radiation workers and therefore, it's 5 rem.

19 Then we said, Wait a minute. They're exempt from all of 20 Part 20, so maybe it's the same limit you would do for the public, 21 and maybe we should limit it to 100 millirem. And then somebody 22 said, Well, NRC has this great idea that general licensees are okay 23 if you expose people to 500 millirem. So we had those three 24 options. The question is what do you really want to do? How do you 25 protect the public?

443 1 Part of this is you've got to know where the material is 2 going, and if you don't know, because there's no notification 3 requirements -- oh. I might say that -- I tried to find out who in 4 Colorado had a problem and I did an internet search. I located 5 three companies that distribute thorium, and we wrote to all three 6 of them, saying, Tell us who your Colorado customers are. But only 7 one of them answered me. So there's two other companies out there 8 that are distributing to I don't know where, and they won't tell me.

9 Waste disposal has two areas that you might want to 10 consider. One is what level do we need to control the disposal of 11 radioactive materials? Clearly, somebody that puts out garbage bags 12 reading 11 mR per hour have to be controlled, but by the same token, 13 you don't want a level where your laboratories are using 14 reagent-grade uranyl nitrates. They shouldn't have to worry about 15 doing anything different; it's not a problem. So where do you draw 16 that level and what do you control?

17 The side issue under the compact involvement is that our 18 compacts have been set up to regulate the import, export, and 19 disposal of radioactive waste, but we now have a waste stream going 20 on and it is totally uncontrolled and even unknown to our compacts.

21 Notification of sales -- somehow, again, if we are going 22 to control these facilities that have high exposures, we've got to 23 know who they are. You would expect that this would have 24 happened -- when I looked through the NRC Part 40 requirements, they 25 list optical lenses under the section of unimportant quantities.

444 1 But the paragraph right under saying, optical lenses with thorium 2 are unimportant, they say, this does not apply to the manufacture, 3 grinding, or shaping of these things. But then you went and looked 4 and said, Where's the requirement for them to have a license, and 5 it's not.

6 And we all know how you need a NRC license for 7 distribution of exempt items, but that's byproduct material, and you 8 look in Part 40 and there's no requirement for a license to 9 distribute exempt items source material. So we have a whole lot of 10 disconnects and we have two, again, who have two classes of license.

11 And again, like the waste issue, the notification of sales says, at 12 what level do you want to do?

13 If it were my recommendation, I think what I'd do is say 14 let's do a study and everybody who received more than 15 pounds of 15 thorium -- that's 10 percent of what they're allowed for a year --

16 and see if it's a problem. If it is, then we'll start looking at 17 those who had five pounds. If it's not, we'll look at those we get 18 100 pounds. You can pick any number you want, but I think somewhere 19 along the line we need to start scoping the issue.

20 I already mentioned the problem about manufacture for 21 exempt distribution. It just doesn't appear in Part 40 and so it 22 doesn't apply. And release for unrestricted use -- that is another 23 issue. There's two sub-issues that probably we need to think about 24 there.

25

445 1 The first is we have a lot of facilities that at one 2 time have used thorium and we don't know where they are. So do we 3 have more orphan sites floating around? Do we have those orphan 4 sites? The second issue that relates to that is where do we want to 5 start thinking about looking at these? Again, what level should 6 they have had before we go out there and look at it?

7 And of course, financial assurance and record keeping --

8 all are byproduct materials if they have a certain amount of 9 material that can theoretically cause a larger contamination. If we 10 want them to have financial assurance -- but the NRC was very 11 consistent in what they did. If you look in Part 40 and look at the 12 curie amount of needing financial assurance, that somebody decided a 13 general licensee does not need financial assurance so the curie 14 amount is above what is required for a general licensee, and hence, 15 they aren't required. But like I say, we're looking -- and it's not 16 disposed yet, but we're looking at 350 to $400,000 remediation 17 program, not counting lawsuits involved, and yet there was no 18 requirement for financial assurance.

19 Fortunately, the SSRs -- and Colorado regs are a little 20 more general than what the NRC is under Part 4 and you can interpret 21 the SSRs in our regs to say, Yes, you need a financial assurance.

22 But the NRC couldn't -- if this had happened to an NRC facility, 23 you'd think it's going to happen over and over again because they've 24 got no mechanism whatsoever.

25

446 1 This didn't come out too well. This is just the side of 2 the petition that we sent. And I said yesterday, it's not the OAS 3 in Colorado. It was the offices of the Organization of Agreement 4 States -- it was posted in the Federal Register the 7th of July, 5 then we have the 20th for comments. And incidentally, I've noticed 6 that as 7 of -- I guess it was last Tuesday, nobody had commented on it, so if 8 any of you have comments, I'd sure encourage you to submit some 9 comments in there.

10 Recommendations -- we need reporting requirements. I 11 don't know what those levels of reporting requirements are, but we 12 sure need to have some information when people are getting enough 13 material to put up dumpsters reading 11 mR per hour. You've got to 14 visit your licensees, but again, you have to know where your 15 licensees are. We have to reevaluate the financial assurance 16 requirements. And just listening to Greta, I think I'd like to 17 modify one of my recommendations.

18 As I had said -- been going to say, that we really need 19 to see what we're doing and maybe get together with the NRC and look 20 at this issue. But I heard Greta say that she's going to start 21 reevaluating the .05 percent limit for exemptions for source 22 material. And to me, it would be a real nice thing if this 23 organization, the NRC, could get a working group together, because 24 to me, the two issues go hand in hand -- is what level are you going 25 to control the stuff and start working on them together.

447 1 And that's all.

2 MR. CAMERON: Are there any questions for Jake or any 3 status reports from the NRC on a petition? And I think we'll note 4 Jake's recommendation that -- about the working group on this, and 5 there may be more to say during the Part 40 presentations that the 6 NRC is going to do today.

7 (No response.)

8 MR. CAMERON: Okay. Well, let's move on to our next 9 topic and then see -- maybe take a break at that point. And I think 10 we have two topics left in this session, and one is the use of 11 laboratory data.

12 Aubrey, this is yours. Do you want to come up here?

13 MR. GODWIN: I'll give you a couple of scenarios.

14 You're sitting quietly in your office, if that ever happens --

15 you're trying it -- and someone appears and says, I've got this 16 small pile of stuff and it has no real hazardous material 17 characteristics in it, and we'd like to ship it over to one of your 18 waste sites here in the state. And we had an analysis run on it to 19 see what it had, and we got some results back, and I want you to let 20 me know if I can do this without getting a radioactive material 21 license.

22 Well, you can't answer at this time, but the answer is 23 no, because nobody comes and asks you that question if they don't 24 have radioactive material. You just don't get it.

25

448 1 Now, there's a couple of things you have to worry about 2 when they do this. There's two or three critical elements you need 3 to worry about. Number one, what kind of sampling plan did they 4 follow to collect their laboratory samples? We promptly refer them 5 to MARSEM [phonetic], and then we start looking at how they went 6 about choosing things such as background.

7 Background's real tricky when you're talking about 8 [indiscernible] materials, and in some case it's tricky when you're 9 talking about byproduct material, if you've got some fallout 10 remaining in your areas.

11 Secondly -- well, when you talk of -- you also have to 12 recognize that it's not a real easy thing. For example, we had one 13 gentleman who came in and had some estimated 700 truck loads of 14 material, and he had 13 samples, and he's ready to say that this has 15 been approved. He would agree to take 17 more before it was over 16 with, so we had 30 samples, finally, out of 700 truck loads.

17 Ed Bailey recently had a problem with about 84 car loads 18 and 26 samples, something like that.

19 MR. BAILEY: Eighty-three.

20 MR. GODWIN: Eighty-three carloads. Excuse me.

21 MR. BAILEY: Train car loads.

22 MR. GODWIN: Train car loads, not small cars, but -- and 23 what they do is they come in and they plop some results on your desk 24 that probably looks vaguely like this, and unfortunately, I can't --

25

449 1 I blew it up but you can't blow it up very well and still have it 2 look like a lab report. That's the problem.

3 And quickly, you're asked to make a decision about 4 whether this is going to fly and a few things. Well, I'm going to 5 talk about the laboratory end of it today. We won't go into sample 6 selection and sample sizing and things like that. That's a good one 7 for somebody else.

8 But looking at this lab report, can anybody see anything 9 that raises your eyebrows about anything here? Not from there?

10 Well, the curious thing you notice on it is the first isotope listed 11 is what? Can anybody read it? Actininium. What's the half-life of 12 actininium?

13 (No audible response.)

14 MR. GODWIN: In that particular chain, it's six hours --

15 goes to thorium 228, if you look real close. Guess what you don't 16 see in that chain?

17 (Pause.)

18 MR. GODWIN: You don't see any thorium 228. Now, this 19 is in soil that's supposed to have been there for about 12 years.

20 Do you reckon it made equilibrium yet? And we haven't gotten to 21 talking about the laboratory, have we?

22 So you see results like this and you wonder how they did 23 some of the testing and finally you figure out they must have done 24 it by gamma because that's really all you're looking at, is gamma 25 peaks and whatever else is in there you wouldn't see. You don't see

450 1 natural uranium up here either, even though the 235 gamma is showing 2 in there, so you wonder where that would be. The point of the slide 3 is to look critically at the data they lay on you because it 4 probably has more stories on it than they really realize or they 5 wouldn't have brought it to you.

6 Now, we had another case -- this is another sample of 7 the same site -- in this case, guess what? They're reporting 238, 8 both of them. So after you see the two, you begin to wonder, Is 9 this the same samples, or what's going on? And then, for you who 10 think that a certified lab is all that great -- and by the way, 11 these were all certified labs -- you need to understand something.

12 The quote, certified lab is for water, not soils, not leak tests, 13 not air, and it's only for certain isotopes. Most of the things 14 that you're looking for -- guess what -- they're not certified all.

15 But the first thing they lay on you when they bring in 16 these reports is, This is a certified laboratory. And this is just 17 a little certification sheet for the boy who brought this one in.

18 We had to do an investigation on this particular one. It gets real 19 entertaining when you really start checking up on them. And you've 20 got to remember now, you're going to be making a determination 21 whether they can bring this in, which puts your use as a regulatory 22 individual very much in question.

23 This was the result they showed us, or one of the 24 results. Does anybody see anything strange on this one? Can you 25 read this one a little better?

451 1 (No response.)

2 MR. GODWIN: Well, it says it's gross alpha result is 3 22, plus or minus 17, with a detectable level of 2 in picocuries per 4 liter. Does that raise any question in anybody's mind? The error 5 is a little bit larger than the detection limit. It ought to raise 6 a few eyebrows.

7 They had been passing out results like this for several 8 years, and this lab has been used by several cities for their 9 drinking water. It had been used by consultants. It had been used 10 by DOE. It had some interesting history to it, and they were a 11 quote, certified lab. We went down and took a look because we were 12 curious about this and we discovered another thing or two about it.

13 This is the data they had recorded.

14 Now, you might can read it a little better now. If you 15 notice on this particular sample, they had 11 plus or minus 17.

16 Wait a minute. I thought the detectable limit was two. But you 17 also notice a little number circled out there by it? You'll see on 18 the next sheet that what they actually put on the sheet wasn't 19 eleven plus or minus 17. It was 17 plus or minus ten. And you'll 20 see it was transferred to our Arizona forms and sure enough, it 21 showed up -- if I got the form -- well, they showed it to us as 17 22 plus or minus ten. I guess I passed it by.

23 Anyway, the point is that you really need to look 24 closely at what they're doing in these laboratories, because the 25 laboratory is what you're going to make your decision on and that's

452 1 where the result really -- making a regulatory decision for you.

2 And it's bad to discover in court that they have reversed the 3 numbers, as they did on this particular report.

4 Now, typical type problems that we see is that 5 commercial laboratories, because they're trying to get as much money 6 as they can and charge as little as they can, because it's 7 competitive out there, they minimize the counting time. What 8 happens to your detection limit when you're minimizing the counting 9 time? It goes up. And when we start telling folks that you're 10 putting out this detection limit. You've got to have the time to 11 count it and show that it gets it there. They say, Well, that's 12 going to cost us money because as quick as they figure out they 13 cannot count it for 20 minutes and get a result out -- they start 14 talking about hours, and that slows things down pretty drastically.

15 Now, when you start talking about counting alpha -- we 16 don't have a sheet on this one, but it turns out the alpha count was 17 very highly suspect. They didn't do any kind of correction for 18 weight of sample. They also didn't do any weight of sample 19 correction for beta, so all of those results became very suspect 20 because as you build up your sample thickness, guess what you do to 21 your counting efficiency? Yes. It goes down. You almost have --

22 once you start getting into this thing, you almost have to go look 23 at the laboratory that you're going to be accepting results from.

24 Now, am I all that good? No. I'm not all that good, 25 but I got a laboratory guy who is good, and I hope each of you have

453 1 a laboratory guy that's good at it because that's what you need when 2 you get into this kind of business. Don't just take one look at it 3 and say, Okay. I'm going to buy it or not buy it. Let your 4 laboratory people take a good critical look at it.

5 Secondly, go with your laboratory people and see how 6 they're doing things at the laboratory that you're fixing to accept 7 the results from. It may mean out of state travel because a lot of 8 these laboratories will not be located where you are. And don't let 9 the fact that it's a DOE laboratory that's being used by DOE slow 10 you down. Go look.

11 Thank you.

12 MR. CAMERON: Thank you, Aubrey.

13 Any other states have similar problems with lab data?

14 Does anyone not? So Aubrey's recommendation about having a good 15 laboratory [inaudible]. Do we want to take up with the last item 16 since Aubrey's up here before we take a break?

17 VOICES: Sure.

18 MR. GODWIN: For those who haven't heard, Seaman's 19 Nuclear has an application pending with the Nuclear Regulatory 20 Commission for a distribution license for a moisture density gauge 21 to be distributed to general licensees. Now, in order to understand 22 the significance of all this, we might need to talk about general 23 licenses just a minute.

24 First of all, one of the basic concepts to general 25 licenses is that they are, quote, inherently safe, unquote. And

454 1 then, depending on which one you're dealing with, you have some 2 criteria that describes what is inherently safe and what they 3 Commission believes will meet that criteria. This particularly 4 device will be distributed under 31.5.

5 There are several general licenses which we have that go 6 state to state and nobody has any problems with them: your aircraft 7 exit lights, your counter weights in aircraft, are just a few, some 8 static eliminators. They are, for the most part, distributed under 9 a different general license. This particular general license, in 10 its current form, calls for notification quarterly of the addresses 11 to which the device was shipped to as the end user. And as a 12 result, you have some record of where these devices are. Now, these 13 devices can consist of almost anything from, again, static 14 eliminators to four and five curie cesium devices.

15 If you look at the preamble or statements of 16 consideration to this 31.5 general license, over the years there 17 have been statements about acceptance of portable devices being okay 18 under it, and at least one of them indicated that moisture density 19 gauges would be an example of an acceptable device that could be 20 placed under 21 there -- be distributed under it.

22 The staff is currently reviewing the application from 23 Seaman's Nuclear, and I had an opportunity in July to take a look at 24 the device and the application. And I'm doing a lot of this by 25 memory because I don't have the application in front of me. But as

455 1 I recall, the maximum radiation exposure level is around 30 mR at 2 contact. And unlike most moisture density gauges, the sources do 3 not come out of the device. The detector tube is placed down the 4 hole as opposed to the source being down hole, so it's a little 5 different from the conventional arrangement.

6 The handle is arranged so that when you pick it up it 7 shuts it off. There is a way to lay it on its side and turn the 8 handle and turn it on, but that's another issue. And it's really 9 quite a cleverly designed device. I must give them credit for it.

10 However, the question becomes, is it inherently safe 11 sufficiently enough that it can be distributed as a general license 12 device to any and everyone who commits to reading the manual and 13 following the manual? And the only address location under the 14 current version you will have will be where it was initially 15 distributed to. There's also some concern under the proposed rule 16 whether you can even get successive addresses and how they would 17 have to give these addresses then should it get moved?

18 I think it's important to know that we do have some 19 portable devices out now that are being distributed under this 31.5, 20 and they have caused, at least in one case, a problem in that they 21 were shipped into one state and used in another state and ended up 22 scrapped into another state. So we have some experience with these 23 being floated around.

24 As you can see from the letter I sent to Carl, I don't 25 believe it's inherently safe, primarily because of the inability to

456 1 assure proper storage of the device just based upon reading a 2 storage manual. I mean reading the manual about storage. It's 3 really difficult for me to believe that a person who is told he's 4 going to have to go out and do a lot of work and whose primary 5 interest is getting the production out on the part of testing the 6 roads and what have you is going to be concerned enough to read in 7 detail what the storage requirements are and the transportation 8 requirements for transporting the device.

9 And if it's not properly stored -- we already know that 10 devices that are stored are being ripped off. I suspect if they're 11 not being stored properly, they'll go faster. And after it's gone, 12 there's not a whole lot of assurance that they're going to let us 13 know about it. And so there's an even greater probability for 14 misuse.

15 Now, the accident conditions that are described in the 16 regulations will not give you sufficient radiation dose to reject it 17 based upon those described conditions. You would need to look at 18 some other basis that I think the storage and adequate security --

19 is the way I approach it, anyway.

20 I also pointed out to them there's no real recognition 21 under our reciprocity regulations to recognize a general license 22 coming from another jurisdiction, and so basically, once you get it, 23 if you get it in Arizona, you'd be stuck to Arizona. If you got it 24 in NRC jurisdiction, you've got nine states you can use it in. That 25

457 1 is one of the issues that will be raise on this new Rule 2, but they 2 want some discussion about it.

3 Anyway, this is my letter and my comments on it. I 4 leave it to you to read. And if you've got any thoughts on it, you 5 might want to write Carl. But I do think it's important that you 6 know that these devices are being considered and you give it some 7 thought.

8 MR. CAMERON: Thank you very much, Aubrey.

9 Does anybody have any questions for Aubrey on that, 10 relative to contacting the NRC? Jake?

11 MR. JACOBI: Colorado sent a few page letter to the NRC 12 about why they shouldn't put these out as general license. But I 13 was just curious, how many states here think that these devices 14 should be generally licensed? Maybe what we need is a resolution 15 this afternoon.

16 MR. CAMERON: Okay. That's so noted for Stan and 17 Richard.

18 MR. GODWIN: If we're going to send them anything, we 19 need to have a basis for telling them why they should reject it, 20 because our regs, at least as far as the staff is concerned, would 21 indicate that they can issue and probably could be forced to issue 22 such a license.

23 MR. RATLIFF: Well, one thing we see, especially in the 24 summer time, the moisture density gauges are most often stolen and 25

458 1 most often run over and damaged. So you're dealing with ones that 2 are not in a situation where they're in a safe, remote location.

3 MR. GODWIN: Just for a matter of interest, they passed 4 out the states that had the most stolen gauges in it. It was 5 Florida, Texas, Arizona, and New Mexico. I don't know how Ed missed 6 it, but he did. Maybe you're number five.

7 But anyway, three of the four close to what --

8 MR. CAMERON: Well, great. Michael?

9 MR. BRODERICK: It's not a major issue but you mentioned 10 specifically to write to Carl. I think he's about to change jobs.

11 They're going to get someone else in that slot, so his office is who 12 you'll need to write to.

13 MR. CAMERON: Okay. Thanks.

14 All right. Let's take a break and come back at four 15 o'clock and we'll take up from there.

16 [Recess.]

17 MR. CAMERON: Okay. If everyone could come in and take 18 their seats? We're running right on time. Okay. We have two 19 interesting and useful presentations now, and Don is going to be the 20 NRC lead on both of them. One is 40.13, and when Jake was talking 21 before, we brought that -- that issue has come up.

22 Ruth McBurney is going to be with us for the state side 23 on that one. And then we'll have Don talk and we'll have Ruth talk, 24 and then we'll have a discussion. And we are going to go into the 25 clearance rule, and for that one, Don is going to take the lead, as

459 1 I said. And we're going to have David Snellings from Arkansas talk 2 on that one.

3 So let's get started with Don. Do you want to go ahead?

4 MR. COOL: The first rule of meetings is take the 5 talking stick away from Chip.

6 All right. Good afternoon. We're going to spend a 7 little bit of time talking about a subject which has been discussed, 8 or is disgusting, or you might say some other things, for a very, 9 very long period of time.

10 I was trying to think of some cute way to introduce 11 this, and the best I could come up with was to simply tell you, 12 Dorothy, Toto, you're not in Oz anymore. However, this is a very 13 interesting land which we have entered upon.

14 Back a few months ago, as we were trying to look at the 15 Commission's direction to go off and look once again, for the 16 umpteenth number of times, on the source material issue, we spent 17 one day -- we went away from [indiscernible] to try and get out of 18 the ivory tower a little bit and try and brainstorm some ideas of 19 what were some possibilities; what could be done to resolve the 20 seemingly endless debates with regards to source material and 21 exemptions and the whole issue.

22 And we spent the first little while trying to figure out 23 what the domain -- what the map of this territory was. Some of you 24 may have heard, you map the territory -- figuring out what things 25 are. And we came up with this little graphic. And I think what you

460 1 will discover over the next moment or two is that whether your 2 source material -- NORM, TENORM, or any combination of the above, 3 you are somewhere on this chart.

4 Originally, before all of this got started, you had 5 material. It happily sat in the ground. Nobody had done anything 6 with it yet. And then along came the Atomic Energy Act. In the 7 Atomic Energy Act, for reasons totally unrelated to health and 8 safety -- the reasons specifically were a dividing line based on 9 what they thought was a reasonable amount of material from which 10 they could extract stuff for bombs -- drew a dividing line -- call 11 it 500 parts per million, one twentieth of 1 percent -- and they 12 defined source material: uranium, thorium, any combination, any 13 physical chemical forms, or ores which contain blah blah or any 14 combination thereof. And they divided the world into two halves.

15 So you had things that were less than that, which was 16 not source material. Let's just leave it at that for the moment.

17 But you can apply the word norm down there. It exists in nature.

18 It's out there. It's in the ground. Nobody has done anything to 19 it. It's just there. Is it above it? Even if it's in the ground, 20 you consider it to be source material.

21 Now, what happens when you do something to the material?

22 You mine it out of the ground. You drill for oil and you pull it 23 up. You make fertilizer out of phosphate materials, or anything 24 else that you might do. Well, we've nicknamed that technologically 25 enhancing it. Well, if you were down in this category, you

461 1 technologically enhance it, and you go up to another line. Now, 2 what kind of regulation applies to that? Well, for the moment, 3 under the current regulations, it's considered an unimportant 4 quantity.

5 Okay. That's 40.13(a). Never got over the criterion by 6 which it was in the definition of source material, but it has been 7 enhanced and that's sort of how you get to the TENORM category.

8 Now, if you were over here on this side and you refined it and 9 processed it -- most likely you were a uranium mill or something 10 like that -- you started out with source material. Voila. You're 11 still source material. You have regulated material. And up here 12 lives all of the uranium fuel fabricators and conversion facilities, 13 enrichment facilities, and the reactors, and everybody else who may 14 be using various materials in unregulated land.

15 Now, wouldn't it be all nice and simple if that's the 16 only possibilities of roots was to go up there, or it could go up 17 there? Unfortunately, thus is not quite the case, because you can 18 start out down here less than 500 PPM, and as a result of things you 19 do which have really nothing to do with the radiological material, 20 you can go over here because you can pull up other factors that are 21 associated with it, and the net concentration of the uranium or 22 thorium could be greater than 500 parts per million. Well, now what 23 do I do?

24 Or you could be up here and for various and sundry other 25 reasons like mixing it with other materials or other ores and slags.

462 1 You can have material which ends up being less than 500 parts per 2 million. Will that make it TENORM? Not exactly. And of course, 3 you have the people who really very much enjoy it, because they've 4 had it under regulation. They've been using it all along, and 5 they've figured out a way to toss it over the fence that way.

6 And it's this latest category that creates a number of 7 the more interesting, recent examples where people have been up 8 here. They've had materials in these categories. They've been 9 under some type of regulation. And they want to deal with it now 10 under some one of the exemptions.

11 Okay. You're totally confused? Good. In that case, 12 we'll move on.

13 All right. The exemption for source material covers all 14 types of materials other than ores established for practicality, and 15 AEA has been excluded from some of the statutes that regulates NORM 16 and TENORM, like TSCA and RCRA. It gets more complicated, because 17 you see, we're not in Oz, but we do have good witches, perhaps bad 18 witches, and various sundry other forms who all think they have a 19 piece of the regulatory pie at some point in time, depending on the 20 kinds of materials.

21 What kinds of materials are we talking about? This is 22 just the short list. We've talked about zircon sands. We've talked 23 about various kinds of minerals, phosphate slags. The list can go 24 on and on and on. We won't need to take additional time on that.

25

463 1 Now, what I mentioned a minute ago was over the last few 2 months, there have been several cases that have arisen which the 3 staff has brought to the Commission's attention, where people have 4 wanted to do various and sundry things like transfer it to a 5 different entity, say in the great State of Texas, without having to 6 manifest it as waste or consider it for analysis under the waste 7 disposal provisions for Part 20. In that case, the Commission 8 concluded that they were transferring it to another appropriate 9 entity and they didn't have to do it.

10 Or our friend Shieldalloy. Roger now has one of those.

11 He's shaking his head quietly. I've wanted to do various and sundry 12 things to their slag pile because, depending on the way they do the 13 analysis, they think some of the slag pile, or maybe all of the slag 14 pile is less than 500 parts per million, so why can't they simply 15 transfer it? After all, it's an unimportant quantity. We've 16 concluded that yes, that's probably true, but we'd really like to 17 know about it before you go sending off rail cars and rail cars and 18 stuff.

19 You have some situations where we've been trying to 20 decommission some facilities, and lo and behold, they generate 21 materials and they think it's less than 500 parts per million, and 22 they want to do the same thing. In that case, the Commission ended 23 up concluded, Yes. They're sort of in the same boat so you can go 24 ahead and approve it, but once again, keep in mind that staff, if 25 your analysis says that the dose possibly could be over 25 millirem,

464 1 please let the Commission know about it, which raised in fact then a 2 very interesting sort of question, how are we going to know about 3 it, because of course, if it's exempt, they don't have to tell us 4 about it.

5 Well, okay. We'll mush on just a little bit here. The 6 picture doesn't necessarily get any prettier.

7 The Commission has asked us, the staff, to give them an 8 options paper for some alternatives, possibility legislative. Go 9 down and see if our friends on Capitol Hill can help us sort out 10 some of this tangled web that we've woven, potentially some 11 rulemaking, maybe an MOU between EPA and NRC -- don't hold your 12 breath -- to try and address this 40.13 issue. Consider the 13 possibility of some rulemaking to at least close the, on a stopgap 14 basis, the fact that someone under 40.13 at the moment doesn't have 15 to really -- there's no obligation to tell me when they're going to 16 do this, so that we can at least take a look and do some sort of 17 evaluation to make sure they aren't going to get themselves into too 18 much trouble associated with it.

19 That paper is due from us into our executive director's 20 office and then to the Commission towards the end of this month or 21 early next month.

22 What I'm going to do now rather than going on, because I 23 think I've painted you an outline of the very complicated picture, 24 is just toss out a couple of questions then stand back and watch the 25 fireworks. To what extent will some of the things that have been

465 1 going on -- EPA's been looking at some of the TENORM, a number of 2 you folks have been doing things -- to what extent does that help or 3 complicate or otherwise -- the picture associated with the 4 exemptions of uranium and thorium? You have these on the slide sets 5 and hopefully, there are copies that are floating around so that 6 when I flip to the next one, you can still remember what the 7 questions were.

8 Would someone besides the Commission be willing to take 9 responsibilities if the Commission decided to say, Okay. It really 10 isn't any of our jurisdiction. The Atomic Energy Act didn't put me 11 into that role. Or if I went to Capitol Hill and said, This is 12 really no place for the Commission to be, and there are other 13 appropriate statutes that EPA has, keeping in mind of course that 14 most of that then gets worked directly through you folks to pick up 15 some of the responsibilities, because the alternative, which would 16 be to move that 500 part per million some direction like down, 17 because 500 parts per million translates to some rather significant 18 doses, as Jake very correctly pointed out.

19 Would it mean that the Commission would start picking up 20 regulating a whole bunch of other people in the phosphate mines and 21 otherwise? And quite frankly, I know I don't want to go there. So 22 the question of who might pick it up and the regulatory structure 23 under which they would -- and then -- one which is sort of inside 24 the Commission, as this probably doesn't need to be debated in this 25 forum -- but it's one of the ones that really drives us nuts right

466 1 now. This would be a significant activity to try to develop an 2 approach, and none of the people who are involved with this problem 3 pay me any money to think about it.

4 And with that, I'm going to turn it over to -- thank 5 you, Dorothy.

6 MS. McBURNEY: Welcome to the real world. The states 7 have to deal with this all the time. And I promise you, at the time 8 I first called Don to find out what he was going to talk about, he 9 wasn't sure, so this was just winging it. But I think it'll fit in 10 nicely with what he's brought up and some of the questions he's 11 raised.

12 I've called the title of my presentation, "Source 13 material exemption: a matter of regulatory equity," due to some of 14 the recent applications and interpretations of this rule, the rule 15 exemption in 10 CFR Part 40, and a similar in the Agreement State 16 regulations. This particular rule which exempts source material 17 that is in concentrations less than .05 percent by weight in any 18 medium is an anomaly when compared to other exemptions, and I will 19 discuss, therefore creating an inequity in the risk basis for 20 exemptions.

21 Some of the events that have brought about this 22 particular rule -- have brought this rule to light and to the need 23 for further discussion include several things. Suddenly, there are 24 large shipments of waste containing source material that are being 25 allowed to go to unlicensed sites, including FUSRAP waste and

467 1 cleanup waste from other sites. Of course, FUSRAP waste was not 2 under AEC so that exemption's another story.

3 The Nuclear Regulatory Commission recently issued a 4 policy in which the exemption in 10 CFR Part 40 and 40.13(a) for 5 source material includes any waste containing source material at 6 less than .05 percent by weight, if it is within the bounding 7 radiological consequence analysis, whatever that means. This issue 8 was raised to the Commission level as a result of the METCOA 9 [phonetic] waste containing source material being proposed to be 10 disposed of at a RCRA hazardous waste landfill in Texas. The 11 Commission concluded that the exemption for source material did 12 include disposal.

13 However, in response to concerns raised about the issue 14 by staff of the Texas Natural Resource Conservation Commission, 15 Chairman Shirley Jackson explained that state and EPA regulations 16 would also need to be met concerning the disposal of this waste. I 17 don't know which regulations, our NORM regulations or the RCRA 18 regulations or just what. But she also stated that the Commission 19 has directed the staff to provide recommendations to the Commission 20 for developing a more risk-informed and coherent set of requirements 21 for licensing of source material, including possible revisions to 10 22 CFR 40.13(a), as Dr. Cool alluded to.

23 This brings us to the next initiating event, the 24 reevaluation of 10 CFR Part 40. In 1992, NRC announced an advance 25 notice of propose rulemaking concerning Part 40 in which the

468 1 licensing and exemption criteria for source material were to receive 2 a fresh look and potentially changes were to be made as a result.

3 The Source Material Concentration Exemption was one of the issues to 4 be addressed in future rulemaking. That was 1992. The future is 5 now, and we have exempt concentrations versus release for 6 unrestricted use.

7 Prior to the latest interpretation of 40.13 by the 8 Commission, if source material that was waste created by a 9 licensee -- a licensed facility in which the resulting waste was a 10 result of that activity, then the waste would have been radioactive 11 waste at any concentration down to the cleanup standards, and only 12 if it was always at the exempt concentration was it considered to be 13 an exempt concentration of source material. That was the way we 14 were interpreting it earlier.

15 Normally, exempt concentrations cannot be used as 16 release criteria for unrestricted use, but in this case, one could 17 have a licensed facility that is contaminated at less than .05 18 percent by weight and would not meet the release criteria, but they 19 could clean up that site and take the resulting waste and send it to 20 an unlicensed facility for disposal. The same material, same 21 concentration, just a different site. One analyzed for dose 22 contribution and one not.

23 Just as a matter of comparison with exempt product and 24 byproduct exempt concentration, exempt products are evaluated 25 carefully for individual dose contributions to avoid any unnecessary

469 1 or any inadvertent dose to the public. As recently shown by NRC 2 policy and brought to light by the Agreement States, it is not legal 3 to combine exempt sources in a single device. Also, disposal 4 usually takes place at one or two or three units at a time, not 5 giant ship loads of it.

6 Product containing radium, which is an alpha-emitter, 7 which is not regulated by NRC, is not included as exempt sources in 8 the suggested state regulations -- in most state regulations except 9 for those that were originally distributed prior to a certain date.

10 The exempt concentrations of byproduct material found in 11 10 CFR Part 30 are based on a particular risk. They cannot be 12 concentrated. They cannot be incorporated into commercial items.

13 And they cannot be used as a volumetric release criteria from 14 licensed sites, therefore can't be incorporated into the waste.

15 We recently received an e-mail from Mike Mobley from the 16 Tennessee Radiation Control Program in which their allowance of some 17 nickel containing very low concentrations of technicium 99 for which 18 analysis showed that the dose to the most exposed individual would 19 be conservatively about .14 millirem per year was highly criticized 20 by the media and Congress. The release of exempt source material 21 could result in doses, although also low, around 100 millirem per 22 year -- far exceed that level that was cited for the free release of 23 the technicium 99.

24 Likewise, we in Texas have received a letter from a 25 legislator who is concerned about a lot of radioactive waste being

470 1 allowed to come into Texas and go to an unlicensed facility in high 2 volumes. So we see a few inconsistencies in the issues when it 3 comes to the source material exemption in 10 CFR 40.

4 This exemption, as far as I could discern in looking at 5 it, has been in the rules since 1947. As Dr. Cool said, it was 6 based on a low-impact assumption at that time and protection of 7 common defense and security, not on a risk basis. At that time it 8 was thought that source material below that amount was not worth 9 trying to extract for its source material content, and that was 10 prior to in situ uranium mining, I think.

11 As stated in the advance notice of proposed rulemaking 12 in 10 CFR Part 40 in 1992, there has been no review for consistency 13 and conformance of these rules with other rules since that time.

14 There's also inconsistency with decommissioning standards. In the 15 February 1999 issue of Nuclear Licensing Reports, one article stated 16 that, quote, the regulations in 10 CFR 40.51(b)(3) and 40.13(a) 17 allow licensees to transfer source material to any person exempt 18 from the licensing requirements of the Atomic Energy Act and 10 CFR 19 Part 40 as long as the source material content is less than .05 20 percent by weight of the material as a whole.

21 However, under some circumstances, transfer of material 22 in accordance with these regulations could result in doses that 23 exceed the 100 millirem per year public dose limit contained in 10 24 CFR 20.1301. In addition, because the regulations do not explicitly 25 provide a regulatory basis for denying such transfers and because

471 1 the licensee making the transfers would be complying with the 2 regulations in Part 40 as they're currently written, the NRC may 3 issue an order to stop a licensee from making such a transfer only 4 when the transfer may result in a potentially hazardous condition 5 that could affect public health and safety. And I think this was 6 done prior to the latest NRC Commission policy.

7 So if you take a look at the concentrations that .05 8 percent by weight would consist of, for natural uranium it comes up 9 to be about 339 picocuries per gram, and for natural thorium, 116 10 picocuries per gram. This compared to the uranium mill cleanup 11 criteria -- we are using 30 picocuries per gram uranium and 15 12 picocuries per gram radium. For the cleanup of other NRC sites, 13 they have used ten picocuries per gram for uranium and ten 14 picocuries per gram natural thorium. And depending on the scenario 15 assumed in the methodology to calculate the dose, these 16 concentrations could result in doses much greater than the 25 17 millirem per year dose limit for unrestricted release contained in 18 the final rules for radiological criteria for license termination.

19 In addition, if radium is in equilibrium with uranium or 20 thorium present in the chain, the radium activities would 21 significantly exceed the 5-15 soil standard. Since radium is in the 22 chain, as Don mentioned, it's all in the source material TENORM, 23 this whole world of these isotopes. This leads us to compare this 24 to NORM in that similar isotopes are involved.

25

472 1 The CRCPD suggested state regulations for NORM allows 2 the release of sites and disposals up to 100 millirem per year as a 3 range. When his rule was sent to the federal agencies for 4 concurrence, EPA did not concur with those sections of the 5 regulations that dealt with release and disposal standards. In 6 their letter of non-concurrence to CRCPD, EPA stated, "Should such a 7 regulation be adopted, the latitude given in choosing appropriate 8 radiation standards up to 100 millirem exposure annually from a 9 single source of TENORM could result in an unacceptable risk to the 10 public, result in inconsistent standards among the states, and 11 potentially result in the creation of new Superfund sites."

12 As we recently heard though, AEA material is exempt from 13 TSCA and RCRA, so -- but if they don't regulate it and the states 14 do, then maybe it will -- I don't know.

15 So what are the implications? Of course the FUSRAP 16 waste again -- but that's another story. The cleanup of other 17 sites -- it becomes a de facto cleanup standard, potentially. And 18 then we have the issue of people wanting to average higher 19 concentrations of this material, mixing it with -- if they're 20 cleaning up, maybe throw some clean soil in and get it down below 21 the exempt level and then ship it, to achieve that exempt 22 concentration.

23 I haven't indicated whether these regulations should go 24 up or down or whatever, but it's clear that there are some 25 inconsistencies and that it should not be used as a cleanup standard

473 1 or transfer for disposal in large volumes. So the rule needs 2 further review, as both of us have stated, and I was glad to hear 3 that NRC is going to proceed on this. And this in conjunction with 4 the source material issues that Jake brought up concerning the 5 general license source material shows the need for further 6 rulemaking in this area.

7 Thanks.

8 MR. CAMERON: Before we go on to all of you, I would 9 just ask Don if he has any comment on Ruth's presentation. I don't 10 think there was anything in there [inaudible].

11 Okay. Let's go to Steve Collins for a first comment.

12 MR. COLLINS: And I've got two comments, the first one 13 for the group, basically.

14 For matter that has source material in it, which is just 15 the uranium and the thorium atoms, the states can regulate that 16 matter based on other TENORM radionuclides present -- the radium and 17 whatever. I have gotten concurrence from a couple of different NRC 18 staff members of that interpretation. So if you have Part N and 19 it's above five picocuries per gram, it's potentially not exempt, 20 and if you've got those rules you can regulate it.

21 My other one is, I can't believe you said that and how 22 dare you? We have identified a problem with adequacy to protect the 23 public health and safety. It's a result of actions and inactions on 24 the part of NRC and the Agreement States, and how dare we seek some 25 other agency to help solve our problem? We need to clean up our own

474 1 dirty laundry, and do not look to some other federal agency to do 2 this. We've got a problem that exists with source material. We're 3 now proving that it's a problem. We need to fix it, and it's going 4 to be lot of hard work and it's not going to come quick and easy.

5 But let's not look to another agency. Let's get some 6 working groups started on solving the problem.

7 MR. CAMERON: All right. Ruth, Don, anything to say on 8 that one? You don't need to say anything.

9 MS. McBURNEY: I agree.

10 MR. CAMERON: All right.

11 VOICE: Amen to the first one.

12 MR. CAMERON: Amen. All right, Aubrey?

13 MR. GODWIN: I can only echo what Steve said. It seems 14 to me that there's been identified a health and safety issue --

15 these levels of source material being released and I think the 16 Commission would be derelict if they didn't proceed to try to solve 17 the health and safety issue. That's a prime concern of the 18 Commission.

19 I'd also point out to the group that there is another 20 couple of exemptions floating around. I'm not sure of the number of 21 it, but there's one for 4 percent thorium and stuff in the aircraft 22 engines and metallurgical equipment. I think if you check those 23 you'll find the doses from that can be pretty high. These 24 exemptions always have been real interesting because they're the 25 only exemptions the Commission has that has conditions with them.

475 1 And I don't understand an exemption with conditions. They just 2 never computed very well with me.

3 And now for the question -- Ruth, you had ten picocuries 4 of uranium as one of your cleanup standards, or --

5 MS. McBURNEY: That was quoted as an NRC --

6 MR. GODWIN: Okay. Does that --

7 MS. McBURNEY: -- something that they had used on one of 8 their --

9 MR. GODWIN: You had above background or --

10 MS. McBURNEY: Yes.

11 MR. GODWIN: -- or including background?

12 MS. McBURNEY: Above background.

13 MR. GODWIN: Above background? Does anybody know about 14 how you establish background? It's a little trickier when you 15 get -- we recommend you use the ICRP 50, I guess it is. Otherwise 16 you find that a lot of areas in this country where the background 17 varies somewhat above what you really think it does.

18 Do you have an answer to that, Don?

19 MR. COOL: Only esoteric: very carefully.

20 MR. CAMERON: Okay. Thanks, Aubrey. We have Paul 21 Merges, State of New York.

22 MR. MERGES: Paul Merges from New York.

23 One of the things that's missed from the discussion so 24 far is this BRC-ing of a million cubic yards of unimportant 25 quantities of source material that we're seeing, and shifting it to

476 1 the RCRA C facilities -- these RCRA C facilities, the way they're 2 licensed, they're only licensed for a 30 year look-see. And if 3 there's no problems associated with the facility after 30 years, the 4 site developer can walk from that site.

5 It's not a site that's designed to be turned back over 6 to the DOE like your UMTRCA mill tailing sites are. It's not a site 7 that's designed to be in state or federal government jurisdiction 8 like your Part 61 sites are. And all this has been done without any 9 NEPA documentation, any support by the Commission of any 10 consideration of NEPA or ALARA, as far as I'm aware of.

11 And I only -- I used a million cubic yards just because 12 of the FUSRAP material. DOE is sitting out there with another 100 13 million cubic yards, that if you set the precedent here it's going 14 to be good for phenol and it's going to be good for Oakridge and all 15 the unimportant quantities down there, and you're going to -- and 16 there's another two orders of magnitude of material sitting on those 17 sites.

18 MR. CAMERON: Okay. Thanks, Paul. And I -- is that 19 going to be an issue that we're going to take up in our FUSRAP 20 discussion tomorrow, or is that sort of stand alone? I mean, does 21 anybody have a follow-up to what Paul said? Let me ask it that way.

22 MR. BAILEY: Yes. But I don't think we have time to --

23 I've got a date tonight with my son -- but there's going to be some 24 follow-up tomorrow on it.

25

477 1 I would like to put a little bit of the FUSRAP thing in 2 the disposal. If we accept the average concentration that the core 3 or its contractor claims was in the 83 train carloads of FUSRAP 4 waste that went to Button Willow and we put it into a program to 5 model doses at a low-level waste site -- and I will tell you we did 6 not put in the three plastic liners, and I'll tell you why later --

7 we show that site exceeds the low-level waste criteria in the 3- to 8 400 year time period. And that's assuming everything stays the 9 same.

10 Now, people always say, Well, you've got to include the 11 plastic liners, and I say, Every container of radioactive waste is 12 thicker than those three sheets of plastic. And in our site, there 13 was not going to be any uncontainerized waste going in, and I think 14 that was a pretty common type thing at all low-level sites. It's 15 all going to be containerized. So if you get that argument, just 16 tell them, A steel drum is a lot thicker in retarding something than 17 is three sheets of plastic.

18 MR. CAMERON: Okay. Yes, sir?

19 MR. McNEES: Jim McNees from Alabama.

20 And I wanted to follow up on what Aubrey said about the 21 4 percent exemption. We're looking at Part 40. We're going to look 22 at 13(a) at the one-twentieth of 1 percent. The 4 percent exemption 23 on devices is real interesting also, but as you said, it's the one 24 that has conditions on it.

25

478 1 If I acquire one of these parts -- one of these 2 manufactured parts, I'm exempt but I have a restriction that I can't 3 perform metallurgical tasks on it. I can't saw it, reform it. But 4 one thing I'm not exempt from doing and that's transferring it. So 5 I got it -- it's 4 percent thorium -- and I can give it to anybody I 6 want to, including an aluminum plant in Baldwin County, Alabama, 7 when they get it and can melt it.

8 So if we're looking at revising Part 40, let's take a 9 look at that 4 percent exemption and whether or not it should have 10 restrictions on it and whether or not transfer should be a 11 restriction on it.

12 MR. BAILEY: Another exemption you should look at is the 13 .25 percent by weight for rare earth products. That one -- you can 14 get some screamers there.

15 MR. CAMERON: Don, is this -- are these going to fit 16 under this rulemaking, or possibly could they fit under it -- and I 17 guess I might as well ask you at the same time. Jake made a 18 suggestion about a state-federal working group on this rule, and I 19 wondered if you and possibly Paul wanted to comment on that 20 suggestion?

21 MR. COOL: Okay. Will you permit me to work backwards, 22 because the last one's easy. I think it's probably a good idea.

23 MR. LOHAUS: Paul Lohaus, NRC.

24 25

479 1 I would agree, Don. I think this particular subject 2 area and the kind of issues here lend themselves very well to an 3 nrc-Agreement State working group.

4 MR. CAMERON: And perhaps one of the issues could be 5 scope of the rule, too.

6 MR. COOL: Yes. Now to move back to the previous 7 question or group of questions which is whether some of these other 8 exemptions are not under the rulemaking, and that's in fact got two 9 pieces of answer to it.

10 One piece of answer is that in theory, all of Part 40 11 might be open. I think what the staff will probably recommend to 12 the Commission is something slightly more bite-sized, as in try to 13 deal with some of this, we don't even know what's happening issues, 14 the 40.13(a), and at least getting notification of it on a shorter 15 term and then dealing through a working group or something on some 16 of the longer issues.

17 There's also a second piece to this puzzle, which is for 18 some fairly lengthy period of time -- unfortunately, it's had a 19 really long gestation period -- there has been underway an analysis 20 to try and reevaluate the doses and implications from the various 21 exemptions in the regulations, both by product material and source 22 material. And I believe the compilation report will be published 23 before this year is over; I'm in hopes within actually the next 24 month or two.

25

480 1 But it's been just long enough since I've touched the 2 time line on that action that I'm not sure exactly what their due 3 date for getting that out for comment and analysis will be, but I 4 would urge you to keep one antenna up and we will -- we're working 5 with Paul Lohaus to try and make sure that the states get 6 notification when that does come up for comment, because that 7 report -- and it's going to be a rather massive piece of material --

8 is an attempt by Oakridge to go through and run a series various 9 kinds of dose models and scenarios on all of the different 10 exemptions; the two we've talked about and lots of the other ones in 11 there to try and evaluate what it is.

12 And the whole purpose of that will then be to talk that 13 analysis and take the comments and propose potential regulatory 14 changes. So there is another mechanism coming for looking at some 15 of these other issues: transfers and some of the other things, 16 which is coming on, because we needed to have something which 17 resembled a logical and systematic underpinning of the technical 18 bases in order to be able to move forward and make some changes. So 19 stay tuned.

20 MR. CAMERON: Richard, do you want to comment?

21 MR. RATLIFF: Yes. I think this is an important rule 22 because one thing we've talked about, these people don't know 23 they're exempt until they go to a scrap yard or to a landfill, and 24 then they realize they have radioactive material. And when you get 25 something like that that really is up in the air as to whether they

481 1 can dispose of it properly, it really takes the confidence the 2 public has in the whole regulatory structure.

3 So I think it's a real important area to address. And I 4 know Ed and I both said we're willing to have people on the task 5 force to really work towards the resolution of this issue.

6 MR. CAMERON: Great. All right. Let's give Don and 7 Ruth a hand and move on to --

8 (Applause.)

9 MR. CAMERON: We're going to go next to the infamous 10 clearance rule, I guess. And Don is going to let us know what's 11 happening here, and then we'll have some comments from David and 12 then get comments from you.

13 MR. COOL: Now, the first thing that you may notice is 14 that the word clearance does not appear on the title slide. Our 15 efforts to establish appropriate regular controls on the control of 16 solid material -- okay. That gives you just a wee bit of a hint of 17 what's going on. If we thought we were in Oz before or someplace 18 else, we are now in the twilight zone.

19 Why are we here? Licensees have material. Licensees 20 have to do something with the material and their facilities and the 21 equipment, and anything else that walks across the threshold of 22 their facility. Not all of that material is going to be a liquid or 23 a gas. A lot of it happens to be a solid. What happens today is 24 sort of hit and miss in various -- depending on the kind of 25 circumstances that you have, because in fact Part 20 does not have

482 1 any criteria for controlling the release of solid material. There 2 is no table in the back of Part 20 which gives you values for solids 3 like they do for liquids and gasses.

4 Licensees make various requests for case by case 5 analysis, most of those being in the context of waste disposal for 6 certain kinds of materials, soils, or other sorts of things. But 7 the fact of the matter is that every single day people release 8 material.

9 Now, they do that by one of generally a couple of ways:

10 the old reg guide 1.86, which has various surface contamination 11 levels. Those were not based on dose. Those were based on basic 12 delectability way back when -- I'm not quite sure how far back that 13 goes. Or, if you're on the reactor side of the house, you wave your 14 white hat around for just a moment and you say, We're 15 non-detectible, except of course when you get under the surface of 16 that, you discover that the next line in the reactor tech specs 17 tells them how hard they have to look and how hard they have to look 18 for surface contamination just happens to be numbers which are 19 exactly equivalent to reg guide 1.86.

20 What it means is that there's a whole variety of things 21 that are going on. There's disagreement over levels. People are 22 installing new kinds of detectors, and what you now have is a whole 23 system that is driven by the Eberlines [phonetic] and other 24 instrument manufacturers of the world whose basic reason for being 25 in business is to move over the decimal place. And every time they

483 1 do that a whole bunch of things which was perfectly appropriate one 2 day, to walk out the door because you couldn't find it, the next day 3 is inappropriate because now you can find it.

4 So in June, 1998, responding to a staff paper on the 5 status of activities for potential waste to proceed, the Commission 6 directed us to start the process which might result in rulemaking.

7 They gave us some relatively clear initial guidelines that it ought 8 to be dose based, not delectability, that we ought to pursue an 9 enhanced public participation process very similar to what was done 10 with the license termination rulemaking in the Part 35 rulemaking, 11 that we ought to be realistic in terms of the health effects and the 12 analysis, and that theoretically at least, we should be looking at 13 something which could be applied to all materials. They gave the 14 staff a little bit of an out to narrow the scope to only certain 15 types of materials if in fact it was impossible to generate the kind 16 of technical bases that would be needed for a more broad based rule.

17 So staff went off and started to develop the process, 18 sent to the Commission a paper which outlined the kind of process 19 that we would intend to pursue, separately sent to the Commission a 20 draft issues paper that we proposed that we would use as part of the 21 public participation in the early parts of the process. The 22 Commission approved the issues paper for use at the end of June, and 23 that set us off on a schedule which has us in San Francisco next 24 week and down to Atlanta, and back to Rockville.

25

484 1 Now, some of you may recall that once upon a time there 2 was Chicago. We'll probably get back there. It has not actually 3 been officially rescheduled. We pulled the plug on that session 4 because by the time the issues paper was approved by the Commission, 5 there really was only about four or five weeks for people to start 6 looking at it, and that was deemed by all concerned to really not be 7 a sufficient time for people to be able to engage in any kind of 8 constructive dialog.

9 In the meantime, we also have a variety of other things 10 going on because you can't just go write a rule on the basis of some 11 public discussion. Actually, you can, but you don't have any basis 12 to support it, which is not a very good place in terms of the 13 Administrative Procedures Act, NEPA, or any other thing. So out for 14 comment is NUREG 1640. That is a technical basis document which 15 analyzes individual doses you could get from releases of various 16 materials, particularly metals -- from the various metals. That's 17 out for comment and serves as a technical basis.

18 We have also contractors now on board to help us put 19 together environmental impacts, extend the 1640 methodology and 20 results to start looking at collective doses so that you can get 21 into the cost benefit analysis, the regulatory analysis, the things 22 that you have to have in place in order to be able to do an 23 environmental impact statement, and this will be a full-blown 24 generic environmental impact statement. Other folks on board to 25 help us work through the whole process of what you can detect and

485 1 what you can survey and how that does or doesn't factor into costs 2 and practicality issues.

3 The issues paper, which I mentioned, lays out the broad 4 range of issues. And you see right up front here that while this 5 lays out a broad range of issues, at the meetings that will be held 6 other options and alternatives that participants may wish to bring 7 forward can also be entertained. This is not constricting. This is 8 just the starting point for the discussions.

9 One approach -- we could stay the way we are or you 10 could do some regulatory guidance. You could just update reg guide 11 1.86 if you wanted to. Or you could move to dose based criteria for 12 unrestricted releases. Or perhaps maybe you only want to have 13 restricted releases, or you want to have a combination of the two, 14 depending on the kinds of levels that you have present. You can 15 move the other direction and simply say, I'm not going to allow the 16 release of materials. Or maybe I'm only going to allow the release 17 of materials that haven't been inside the restricted area, or maybe 18 I would only allow the release of materials -- and you can start 19 adding any different sets of conditions which from various 20 practicality standpoints might allow you to define classes of 21 materials.

22 A number of decision making factors, both in terms of 23 the regulatory analysis that we might eventually need to put 24 together: environmental impact statements and otherwise, human 25 health impacts, a cost benefit analysis, the ability to measure it,

486 1 and other things that happen to be out there which set precedents 2 for us -- one of those happen to be international standards, things 3 which the states may have in place, other things which may be 4 happening nationally -- the international actually plays a much 5 larger role than a lot of folks may realize because there are 6 similar activities going on.

7 The International Atomic Energy Agency sets standards 8 basically applied throughout the rest of the world, and within the 9 European Community, the EC, where standards like this are already in 10 the directive and the EC countries are mandated by treaty to adopt 11 those by May of next year. So quite frankly, there are standards 12 which are already getting pretty well firmed and locked down outside 13 of the United States. And this is one of the things that has to be 14 kept in mind, because it would be a very interesting situation if 15 there was one form of doing business inside of the United States and 16 a whole different thing happening to come across the border, which 17 makes life very interesting for the State Department and Customs and 18 EPA, whose job responsibility is to do be the lead federal agency in 19 responding to some of these sorts of activities.

20 So where do we stand today? In this tumultuous land, as 21 you might expect, there has been a slight, small, negative reaction 22 to the issues paper and the whole concept of public meetings to 23 possibly establish rule. I've just had enough caveats in there.

24 More bluntly, there's a boycott going on by the environmental 25 community. They've said, No way. We're not going to come. We've

487 1 told you what we want to do before, read zero, no release. We don't 2 want anything to ever come out of a reactor or a defense 3 establishment, so we're not going to participate.

4 This of course brings up the very interesting question, 5 Well, that's all well and good. What are you going to do about the 6 nuclear pharmacy down the street, and what are you going to do about 7 all these other uses, and how does this related to NORM activities 8 and other activities, and where's the consistency? I don't care. I 9 just don't want anything to come out of a reactor. You get some 10 very interesting sorts of viewpoints. And don't take this as a 11 total characterization. That's just one or two sorts of views, but 12 they have some very strongly held positions in this matter. And at 13 this point, we don't expect them to come participate in the 14 meetings, although we do have a pretty clear idea of the kinds of 15 views they would have.

16 The Commission, in just the last week or so, has 17 reaffirmed that it wants us to move forward with the process as it 18 was laid out; to move forward with the issues paper, to go ahead and 19 hold the meetings. Fundamentally, you were posed the question, if 20 you don't have a series of stakeholders with which to participate, 21 do you move forward with the process or not? The Commission 22 believes that it is critical to go ahead and move forward. This is 23 a national issue. If anything, the press -- the issues that Mike 24 and the folks in Tennessee have had with the nickel and the DOE 25 complex and otherwise, simply bring into a sharper focus the

488 1 fundamental fact that there is no national standard to deal with 2 volumetric or solid material contamination.

3 Thus, the Commission feels it's important to go ahead 4 and move forward and try to start this process and engage the 5 discussion which may lead to some standard. Will it be rulemaking?

6 I don't know. But of course, rulemaking would be needed to do 7 anything other than to just maintain the status quo. So while it's 8 interesting what the environmental groups might want me to do, which 9 is to say, No release, would require a rulemaking. It would require 10 a generic environmental impact analysis and the whole other set of 11 things that go along with it, just as setting a dose based standard, 12 without even talking about the number, would require a rulemaking.

13 So we're going to proceed to move forward with those 14 activities, address them in open forums. Ye all come, if you want 15 to. It ought to be a very interesting time. Chip is really looking 16 forward to it.

17 And so just to wrap up this quick little status summary 18 for you, what are the opportunities for some of you to get involved?

19 There are a number of them, and there are a number of places where 20 you may be able to exert leverage that I simply can't from my 21 position. One of them, and sort of the obvious one, is come and 22 participate in the meetings and make your views clearly known during 23 those discussions.

24 Then there are other places where you have opportunities 25 to interact with people and express viewpoints. Your legislators at

489 1 both the state and federal level -- yes, it's got big time 2 visibility in Washington down on Capitol Hill, and there are some 3 rather interesting views with regard to that and it probably would 4 be very useful for your folks to understand where you're coming 5 from. Interactions with other folks that you have within the state 6 organization -- this is an issue that transcends the Bureau of 7 RadHealth, or whatever your particular organization may be, because 8 you're going to have to involve your solid waste folks and other 9 folks who may be in other sectors of your state organization to get 10 a consistent state view and approach to the issues. And that may 11 involve a considerable dialog to bring those together.

12 Discussions with the folks that you have, because there 13 are a lot of other people out there -- this is an issue which goes 14 well beyond. You have the various solid waste handlers. You've got 15 steel and scrap recyclers and other people. This is not simply a 16 matter of, it walks out the door and gets buried in a landfill or 17 something. Now, that's one possibility but there are a lot of other 18 possibilities out there. And discussions in addition to the 19 discussions that the NRC would have with various public groups, 20 because you have a lot of folks that you can, or perhaps need to see 21 and interact with.

22 There is some measure of -- I hate the word --

23 education, but coming to a better mutual understanding of what's 24 involved, what the implications are, and how it fits into the 25 pattern, how it fits in with the total scheme of activities -- it

490 1 should be a very interesting process. We are due to take the 2 results of the series of interactions back to the Commission spring 3 of next year and then lay out for them those results, and whether a 4 recommendation is then proceeding forward with a specific rulemaking 5 and the time frames that would be associated with that. What 6 exactly are the next steps in the process?

7 Thank you very much, and I'd love questions.

8 MR. CAMERON: Thanks, Don. And I think these 9 opportunities for a state involvement are really well measured up 10 there. And we should point out at this time that this rulemaking 11 does have a -- not only a state-federal working group but a steering 12 committee. And Steve Collins from Illinois has been with us from 13 the start on that.

14 I think David has some probably practical examples here 15 that are relevant.

16 MR. SNELLINGS: Yes, I do.

17 MR. CAMERON: Go ahead.

18 MR. SNELLINGS: Okay. First of all, Arkansas is not one 19 of those ones on your next to the last slide that has opposed this.

20 I think that this is an excellent process, that we need to do this.

21 However it turns out, we need to go through this process.

22 We have gotten a little early look at some of this.

23 Back when Stan asked for an agenda item, we were really involved 24 with one of our NRC licensees in our state and some negotiations 25 relating to the clearance rule. And so I asked Stan to please

491 1 include clearance rule on the agenda, and I thought at the time that 2 I would get up and say a little bit because the things that we were 3 addressing -- it was related right down the line.

4 The licensee in our state is actively pursuing the 5 clearance rule -- and I'm using that. Even though you didn't, I'm 6 using that terminology -- the clearance rule methodology to initiate 7 a tech spec change to do this now. And they have been told that, 8 Yes, that's the right way to proceed on this thing. And not 9 discussing the merits of the issue, whether this is the right thing 10 to do, the dose related merits and all that -- not discussing that.

11 What we are concerned about is that we have a law in Arkansas that 12 prohibits disposal of low level radioactive waste in anything but 13 above ground facilities. And some of the materials that are being 14 talked about to be disposed of is secondary system mine exchange 15 resin, slightly contaminated, a few hundred counts above background, 16 want to put it in a landfill.

17 Well, you can't do that. You can't do that in Arkansas 18 and still live by the existing law. And this law was passed back in 19 1987. And so how does the issue of a tech spec approval by the 20 NRC -- how does a process like this, if it comes out with rules, et 21 cetera that allows this, does all of this preempt Arkansas law? At 22 the time that we put this on the agenda -- that I asked for it to be 23 put on the agenda, the answer really wasn't that clear.

24 And I've worked with Paul and several other people in 25 state programs, and they have identified for me a change -- and let

492 1 me make sure I get it right -- the Energy Policy Act of '92, which 2 basically says that states still have the authority -- this is the 3 old BRC stuff that when I was away from Arkansas, this was done.

4 But anyway, the old BRC stuff, but it still applies, as I understand 5 it, and it says that states can regulate on the basis of 6 radiological hazard and the disposal of low level radioactive waste 7 in their state.

8 And so how does all of this and the Arkansas law -- and 9 I understand a lot of other states have the same type of law -- how 10 does all of this interact? And it really presents us some 11 opportunities for state involvement in the enhanced process. That's 12 great. That's well and good for a year down the line. If the 13 licensee in Arkansas decides to pursue this, how does that tech spec 14 approval, if it's approved by the NRC, how does it interact with 15 Arkansas law? Does it preempt Arkansas law? No, I don't think it 16 does, and we will let the attorneys hassle that one out.

17 But that's where we are on this thing, and I see some 18 other topics that were talked about in the previous talk; the same 19 thing applies. If a state has this kind of a law on its books, 20 you're not going to get -- at least I don't think you're going to 21 get state legislatures to change it, because in Arkansas now there 22 is concern building again for host state, and that's where all this 23 came in.

24 And then I think an also equally important thing -- and 25 Ed, I thought, said it real well earlier -- public outrage factor.

493 1 I don't see much of that in any of these nice, formal presentations.

2 How do you assess that? What do you do with that? How do you 3 communicate this, add to that public -- add legislator outrage 4 factor? When you have to live with it every day and you pick up the 5 phone and all of a sudden it's Senator So and So from southern 6 Arkansas, Why in the world are you doing this? It's a no-win 7 situation for you.

8 So whatever this working group is, they've really got 9 their work cut out for them to work on this public outrage factor.

10 MR. CAMERON: Okay. Thank you, David.

11 I would point out that there is a discussion in the 12 issues paper that Don mentions on the provision in the Energy Policy 13 Act that David mentioned. And it's not just an issue for states 14 that might have some provision enacted like David, but what the 15 states could do prospectively in that regard, vis a vis whatever the 16 NRC does. And I guess I would just ask Don perhaps to address this 17 issue apart from the legal issue. And I think we're going to have 18 Hampton say something about that in a minute.

19 But how we will approach the everyday, so to speak, 20 decisions that are being made within the Agency on clearance or 21 release of materials while this generic standard is being worked 22 on -- and then we'll go to Hampton for some National Energy Policy 23 Act elucidation.

24 Don?

25

494 1 MR. COOL: Very quickly, the staff is really wrestling 2 with the what-do-we-do-in-the-meantime syndrome, not just from the 3 standpoint that Dave has pointed out. The practical necessity is 4 that every day licensees have the need for and will continue to have 5 the need to take actions.

6 I expect that we will be taking -- and it may not 7 necessarily take the form of a formal paper -- some proposals of how 8 we would proceed to the Commission in terms of the policy question.

9 The leading candidate, of course, is to try and pursue more or less 10 the status quo in terms of looking at individual actions as they 11 come in. And circumstances which portend a policy implication, a 12 large action or a higher visibility action or a unique modeling 13 action which doesn't readily fall under the criteria -- a tech spec 14 change certainly falling into that category -- I would expect -- and 15 this is just Don Cool, a division director in NRC, views, so don't 16 take this as the NRC party line at the moment -- that that would get 17 taken probably all the way to the Commission before such an action 18 would take place, in order to assure that the policy implications 19 had been thought through at the senior management process.

20 MR. CAMERON: Okay. Hampton Newsome is with the NRC's 21 Office of General Counsel. Hampton?

22 MR. NEWSOME: As Chip mentioned, this provision in the 23 Energy Policy Act has raised in the issues paper -- and we're 24 expecting to get some feedback from it.

25

495 1 It was encoded in Section 276(a) of the Atomic Energy 2 Act. It's a very interesting provision. It has not been 3 interpreted, as far as I know, by the courts. It hasn't received 4 much attention at all, and so you can -- if you do a search on it 5 you won't find much beyond the actual language there. But it 6 promises to play a role in the development of this -- in this area, 7 and we look forward to hearing -- we expect to hear different views 8 on what kinds of impacts that provision will have, and we'll see how 9 it goes as the process moves along.

10 MR. CAMERON: Thank you, Hampton.

11 Larry, do you want to offer something?

12 MR. CAMPER: I do. Let me pick up on Don's comment, our 13 concerns about what we do in the interim. And I'll share with you 14 again -- this is informal as well. I'm speaking from my discussions 15 along with John Greeves, my division director with NEI on the tech 16 spec issue.

17 NEI is looking at, and had an informal discussion with 18 us about some type of generic approach for modification of tech 19 specs and release of materials under the umbrella of -- we currently 20 have effluent releases for liquids. We have air effluent releases.

21 And therefore, it would seem to be appropriate that there were some 22 solid materials effluent releases as well.

23 Now, we raised a couple of concerns in that discussion.

24 One was this concept of viewing it as an effluent release, and we 25 discussed some of the differences between solid material and the

496 1 effluent release that we have today in Part 20. But we also 2 cautioned Paul that we have a great deal of concern at this point in 3 time, and sensitized any eye to the fact that any movement away from 4 what we have been doing, the status quo in Don's slide, causes us a 5 great deal of concern in terms of putting any change through the 6 appropriate due process, public awareness and what have you, at a 7 time when the Commission is looking at this idea of clearance. So 8 any dramatic change from what we have been doing causes the staff a 9 great deal of concern and would have to be factored into the overall 10 process.

11 So Paul and NEI were going to chew on that and think 12 about it and we'll probably be having more discussions with them 13 informally, but we did run the flag of concern up on the tech spec 14 issue.

15 MR. CAMERON: Okay. Thank you.

16 States around the table? Steve?

17 MR. COLLINS: When our director asked me, What's all 18 this process about, I knew I could get his attention quickly by 19 saying BRC, which Dave mentioned.

20 A very brief history on this -- NRC and a lot of the 21 Agreement States that have been faced with some of these issues, 22 even before BRC came up, were basically saying if you model a 23 situation and make a case by case proposal to me and it turns out 24 that it's less than 1 millirem or certainly in the 1 to 10 millirem 25 range, you can probably get a case by case approval for release of

497 1 this material. NRC tried to adopt a policy to that effect called 2 BRC. Needless to say, they weren't successful in that policy.

3 So if you back off and say, Well, we still get the case 4 by case things. We're still basically using the same back of the 5 pocket unofficial criteria. Everybody thinks that 1 millirem, by 6 ICRP definition anyway, is a negligible individual dose, and so 7 that's a pretty safe level that we can all go by to release 8 something. So if you were going to do a rulemaking, you'd need to 9 model a lot of the common situations that you would expect to have 10 from NORM materials that exist in large volumes already, 11 particularly some that have a high economic value, if they can be 12 released, to model those, which has been done as part of a technical 13 basis for rulemaking if you decided to have a rulemaking.

14 And then if you decided that you were going to use that 15 criteria, certainly you would want to establish that criteria by 16 using every step of the Administrative Procedure Act appropriately, 17 and even open it up for wide stakeholder input. And that is how I 18 explained to my bosses, where are we at today?

19 We're in a wide stakeholder input into something that is 20 to discuss the options, one option of which is to have a rulemaking, 21 if that's the way we decide to go. To actually put in the rules the 22 criteria that's kind of being used now on a case by case basis by 23 most any of us that get these questions.

24 MR. CAMERON: Thank you, Steve.

25

498 1 Anybody else around the table or in the audience want to 2 comment on this before we go to the business meeting? Paul Merges, 3 and then we're going to go to New Mexico.

4 Go ahead, Paul.

5 MR. MERGES: All right. I'm Paul Merges from New York 6 again. Just because you adopt a dose-based criteria doesn't mean 7 there's going to be consistency among federal agencies.

8 We had a site in New York state, same site, same 9 radiological conditions. Two different federal agencies modeled the 10 site. One comes up with a cleanup standard to meet a 25 millirem 11 per year maximum exposed number to the general public and comes up 12 with 600 picocuries per gram. The other federal agency a few years 13 before that did exactly the same thing, only they marked it up to 14 come up with 100 millirem per year. But they used conservative 15 scenarios and they were 60 picocuries per gram was the cleanup 16 standard for total uranium.

17 What I'm getting at is just because you apply a dose 18 criteria doesn't mean you're going to get consistency in the system.

19 You need consistency among your federal agencies but also you need 20 consistency among your decisions of the path. You've got a very 21 sophisticated public out there and they're aware that you cleaned up 22 this site here and you did it at 60 picocuries per gram but on the 23 other side of the state you want to clean up to 600 picocuries per 24 gram. Now, why am I and my children going to be exposed at 600, but 25

499 1 the kid next door, exact same type of site to the other site, only 2 gets 60?

3 You've got to start looking at what you've done in the 4 past and keep that moral outrage down of the public, besides looking 5 at a generic criteria. And don't expect it to be a simple thing 6 where you're going to adopt relatively loose scenarios, because the 7 public is a lot more sophisticated than we realize they are, I 8 think.

9 MR. CAMERON: Good point, Paul.

10 Stan?

11 MR. FITCH: Well, this is an idea that's long overdue, 12 and needless to say, I'm looking at it from a perspective of the 13 bottom up, because I was part of the regulated community at one time 14 and it's like they just simply gave us guidances instead of 15 regulations.

16 Now that I'm a regulator, I go to some of our licensees 17 and say, Well, you're setting criteria for us that you can't force 18 because it's not a regulation. Well, we need a regulation. We need 19 clearance rules that are tenable, something that when we go to them 20 we can cite them on. Reasonable programs for release of materials 21 is certainly overdue, and I think using a base criteria of 1 22 millirem is probably ludicrous because that seems like an awfully 23 low number.

24 MR. CAMERON: Okay. Thank you, Stan.

25

500 1 And as Don mentioned, we are starting with public 2 meetings and we welcome Agreement State participation and views in 3 those meetings. And I have a feeling this is going to be a long 4 process and hopefully, there will be a lot of opportunities for 5 input.

6 And with that, I guess that would close the formal part 7 of the meeting? We have -- Ken?

8 MR. WANGLER: I don't want the last word.

9 MR. CAMERON: You don't want the last word? I'm sure 10 someone would. Go ahead.

11 MR. RATLIFF: Just for those of you who are not staying 12 for the business meeting that are coming back tomorrow, we're not in 13 this room. We're up in the Atrium level in the Wedgewood Room.

14 It's just right opposite of the registration area. And then we do 15 have this list. Anyone that wants to sign up for transportation, 16 we'll try to get it to the bellman in the morning first thing. And 17 like they told me when Cindy Cardwell checked, is if three or four 18 of you go together, the taxi is cheaper. It's like $32 for a taxi.

19 But I'll leave this here through the business meeting 20 and then try to get everybody to determine do you want the shuttle 21 or do you want to try to pair up with each other?

22 MR. WASCOM: Does that list include Saturday?

23 MR. RATLIFF: No. Tommy will have to do that for you.

24 MR. WASCOM: Okay.

25

501 1 MR. CAMERON: Okay. Eight o'clock tomorrow, Wedgewood 2 Room, and --

3 MR. RATLIFF: It's real close for checkout and the 4 elevators and everything.

5 MR. CAMERON: And we have a catchy title for the first 6 presentation, What's happening with FUSRAP? And then something that 7 seems -- I don't know why it seems appropriate to talk about weapons 8 of mass destruction after that, but it does.

9 We're going to reconvene in just a few minutes. If 10 you'll come back at the bottom of the hour, in about five minutes, 11 we'll reconvene to the business meeting. Thank you.

12 [Recess.]

13 MR. MARSHALL: All right. Let's get this started. With 14 time passing, the agenda gets more and more complicated, so let's 15 get it going here.

16 If you'll go to the printed meeting agenda in your 17 package, I think we need to add a couple of things that have come 18 up. I've had some suggestions. I was just handed another 19 resolution; a ballot form that reminds me of yesterday's discussion.

20 We need to put some things in order here on the agenda.

21 If you go to the bottom half of that meeting agenda that 22 starts around four o'clock, it's got about five or six bullets. We 23 need to add -- I have a resolution from OAS to support the NRC 24 budget. If you'll add that. I also have -- I see Floyd Hameter. I 25

502 1 haven't seen Floyd in 15 years. Good to see you -- and Steve 2 Collins, to comment about IMPEP review of the NRCSSD.

3 I think generally -- I'll say it now, and you can think 4 about it and give ideas by the end of this session -- Richard, 5 Roland, Ed and I, and possibly others are going to brief the 6 Commission on October 20. We've had a skeleton draft agenda since 7 about January, and we thought we would be there for an April 8 briefing. Some things have evolved and regressed and gotten worse, 9 so we'll take any items for consideration for a briefing.

10 And that, I think, is the agenda, besides yesterday's 11 resolutions and the issue of consideration for secretary-elect.

12 Aubrey?

13 MR. GODWIN: I would like to suggest and make a motion 14 at the appropriate time relative to a sense of the group -- not a 15 resolution, but a sense of the group to support the not issuing a 16 license to Seaman as -- for a portable moisture density gauge. At 17 the appropriate time I'd like to make that motion, whenever you 18 decide -- I presume you have other business somewhere down there?

19 MR. MARSHALL: We can sure add that to the list too.

20 Okay. I appreciate -- Floyd will like this. I'd like 21 Steve and Floyd to talk first so Floyd can go home. Come on up 22 here. You can stand or come up here and sit if you like, Floyd.

23 Either one.

24 MR. HAMETER: Howdy. I just wanted to give you all a 25 Texas greeting.

503 1 Back in November, I guess you could say a team was 2 formed of several Agreement State members technical staff and one 3 individual from the Office of State Programs to do an evaluation of 4 the sealed source and device program of the NRC, and using the same 5 IMPEP criteria that are used on the state programs and the regional 6 offices of the NRC. When I first got there -- well actually, when I 7 first started reviewing for this thing, I sort of felt like Don 8 Quixote, and I was assured that these windmills were actually 9 dragons. So we had to go out and look for the dragons. So I 10 started learning real quick what the IMPEP process was all about.

11 And just as an aside, for all of you that haven't done 12 it, we've done our own internal IMPEP, and it's an extremely 13 important learning process for your senior staff so that they 14 understand what's being required of you in the IMPEP process. We 15 went up in the last week of March and did all of our reviews of the 16 device sheets and the reviews of the program and the staff, and I 17 don't know, in some ways I still feel like Don Quixote.

18 I started looking at the rules of the way an IMPEP is 19 supposed to be done and it was totally entirely different from what 20 I envisioned it. Instead of going up there and saying, You don't 21 have this information so we can't tell if you've got a good program 22 or not, it's, You don't have this information so we can't prove that 23 you're not doing the things that you're supposed to be doing. So it 24 caught a couple of us by surprise. I'll just say it that way.

25

504 1 Basically, what we looked at -- it was just an 2 abbreviated IMPEP that the states get, except for the fact that it 3 was just the sealed source and device indicators. So all we did was 4 look at the technical quality of the sealed source and device 5 reviews, the training of the staff, and -- I can't remember the 6 exact terminology of the last one -- evaluation of defects and 7 incidents regarding the SS&Ds. This was covered by Jim Myers, the 8 NRC representative.

9 Apparently, there had to be a representative from the 10 NRC on board because they wouldn't let us state staff look at their 11 secrets, I guess you would call it. Eric Jameson from Georgia and 12 Gibb Vinson from Illinois were the other team members.

13 And one of the things that I noticed was the fact that I 14 guess mainly it was an indictment of the IMPEP process for SS&Ds was 15 the big thing that I saw, and the fact that for sealed source and 16 device programs, the criteria demand perfection. Instead of -- and 17 like inspections are license reviews, instead of them saying most, 18 the criteria is all. So everything has to be perfect. And if 19 you've ever tried to come up to a perfect standard, you'll know that 20 there's no way anybody can do that.

21 And that's basically what we found, was that there were 22 several things that they weren't doing, although they -- I don't 23 know exactly the right term -- they argued the point that, because 24 they were doing things by NUREG 1556 Volume 3, and since it wasn't 25 out until the middle of July of '98, those were the only ones that

505 1 mattered. Everything before that was not couldn't be evaluated 2 against that standard.

3 I still believe that document is just a written version 4 of what we've been doing for the last ten years anyway. And in 5 fact, it's probably -- I can probably ask any one of you to stand up 6 and you'll probably tell me that every time you had an IMPEP or 7 whatever the process was called before that, when the SS&D folks 8 would come down and talk to you they'd say, Well, you've got to do 9 it this way. And so we were taught to do it that way.

10 And in many cases -- well, I'll try to make this short.

11 We looked at -- I could probably talk about this for several hours.

12 When you live this for a week, you -- well, actually it was several 13 months. But basically we found their program, quote, unquote, 14 acceptable. Well, I think -- I can't remember the exact 15 terminology. I've already forgotten it. I guess it was such a 16 traumatic experience I forgot everything. Satisfactory, that's the 17 term. Everything was satisfactory.

18 We had some -- had one item satisfactory with 19 recommendations for improvement. We would like to have made the 20 whole thing satisfactory with recommendations for improvement but 21 the way the rules go, you can't do it that way. You have to give 22 them satisfactory.

23 Generally on the whole, my observations were we had --

24 this is from my point of view. This is not the team's viewpoint. I 25 saw some changes of attitude from the beginning of the week to the

506 1 end of the week. I saw some -- I won't say arrogance, but -- and I 2 won't say superiority, but they were -- the staff -- well actually, 3 the new staff -- that was the other thing too, is their program was 4 almost entirely brand new. They did what I call a rush job on 5 trying to qualify all these people, and I guess you'd have to say 6 they accomplished their goals.

7 But because we were supposed to be looking at the last 8 four years of information, and we only got to see probably a little 9 less than a year's worth of information that they were willing to 10 say, We're going by these procedures, we didn't really have a good 11 handle on what was going on except for the fact that just from our 12 personal experience and contacting with these people, we knew what 13 their internal procedures were, and that they were doing this for 14 the last ten years and yet, some of the things they were telling us 15 to do, they weren't doing.

16 For example, how many of you in here got dinged because 17 you didn't have your review check sheets for the device evaluations?

18 Almost every one -- in fact out of the 26 or 28 device evaluations 19 that we looked at, I think we saw one in these files. And I know 20 every time I was involved with one of these things, the first thing 21 they asked for was, Where is your check sheet? It's in the file, 22 and show it to them. It's got everything in there. It checks 23 everything off. So they know exactly what we looked at and what we 24 didn't look at.

25

507 1 That's one of the big complaints I had was the fact you 2 couldn't tell what they'd looked at or hadn't looked at. They said, 3 Trust me. We know what we're going. We checked everything that was 4 supposed to be checked and we ignored everything that wasn't 5 supposed to be checked, so we did it right. And that's one of the 6 problems that I had with the IMPEP process in the fact that you're 7 innocent, even if there's no evidence that can support either 8 innocence or guilt, so you have to take their word for it.

9 And I guess that's good, but if it's done properly there 10 shouldn't be these little nit-picky things that happen. That's 11 again, my personal opinion.

12 There were three things that we discovered that needed 13 to be changed with the whole system, and that 14 was -- the handbook 5.6 part 3, as I said, appears to be an absolute 15 standard where all aspects of the sealed source and device program 16 must meet the standard to be satisfactory. We proposed, and I think 17 the MRB accepted, the premise that maybe this should be rewritten to 18 come in more in line with licensing actions and inspections.

19 We had a problem with the term concurrent review. One 20 of the things we discovered during the week was that there probably 21 is as many ways to do a sealed source and device evaluation as there 22 are Agreement States. We heard about some states doing it by 23 committees. Some states do it by having two complete, independent 24 reviews. Some people -- some states do it by having one 25 knowledgeable individual do it and then a supervisory person check

508 1 to make sure that all the points were covered. We had a little 2 problem with that, so we turned it over and requested that somebody 3 come up with a specific definition of what that is, and if it's even 4 needed.

5 We indicated a recommendation that the NUREG 1556 Volume 6 3 needs to be reviewed and determined if any revisions to it need to 7 be made. There were several philosophies and whatever that were 8 proposed during the week we were up there -- or excuse me -- the 9 week and a half that we were up there, counting the half a week that 10 we were up there for the MRB. Several proposals were made as to how 11 these were changed. I think the NRC came up with a committee to 12 provide some kind of criteria and guidance. I personally think the 13 committee should have been larger than what they had because --

14 personally because I'd like to have been on the committee.

15 Well, basically, I guess I can say that the people in 16 NMSS discovered that -- I guess, to be nice, they discovered that 17 there are other knowledgeable people out there in the Agreement 18 States that know just as much how to do device evaluations as they 19 do. And again, like I said, it goes along with that feeling that I 20 had that the attitude had changed, because there was, I felt, a 21 better feeling after the thing was over, that they had -- and I 22 think the statement was made during the MRB meeting that we need to 23 start working more closely together and interacting as equals, 24 rather than as NRC state. And I think that they did change their 25 attitude a whole bunch in that respect.

509 1 I think Steve Collins has some comments that he'd like 2 to make. I think he's drawing on some comments from Gibb Vinson, 3 one of our other members, and -- well, I'll let him tell you what 4 Gibb says.

5 MR. COLLINS: The way I initially got involved in this 6 was I volunteered for the OAS to -- since we were trying to meet 7 kind of a short time deadline to try to put together a team real 8 quick that would meet the needs to get this review done and the 9 process started in a short order so people could be trained in a 10 regularly scheduled training time to do this.

11 I called Richard Ratliff and asked him if Texas was 12 willing, and he basically said that Floyd would do it, without 13 checking with Floyd, so we greatly appreciate your efforts, Floyd.

14 And then I went to Joe Klinger, and basically what I had done was I 15 had already asked around, What's the two or three most experienced 16 people in the country at doing SS&D evaluations? And Floyd Hameter 17 had about 18 years plus. I think Gibb Vinson had 14 or 15 years 18 plus. And so we had a good core of a team.

19 And then I went out asking very quickly for some 20 volunteers. Roland had a staff member that would have been 21 available at a different time slot. Eric Jameson from Georgia, Bill 22 from Arizona -- Bill Wright and one other name, I think -- so we had 23 several backups in case one of these team members got ill or 24 something like that. And we got the team put together really 25 quickly so the training could go on.

510 1 And then I got asked to basically bless what had been 2 proposed. That went forward to the Commission and that started --

3 and then I volunteered myself to be the voting member on the MRB 4 when it came up, and didn't get any objection to that from the OAS.

5 So my participation was originally putting a team together and then 6 backing off and saying -- when Floyd called me and asked for help, I 7 said, Well, I'll help, but, Floyd, it's really your job to work with 8 Cathy Snider [phonetic] and the others to learn this and get it all 9 going. I'm not anything other than a general adviser until MRB time 10 comes.

11 I did talk with Gibb Vinson and get his input and 12 reactions as a member of the review team on this, and so I'm going 13 to paraphrase some of the remarks he made. In general, some of the 14 NRC staff had the same reaction that the Agreement States have 15 towards IMPEP review. That is, there was some special agenda and 16 that the adverse findings were unjustified. This certainly was not 17 the case. From the Illinois perspective, the review team members 18 went to pick up pointers on how to improve the Illinois program but 19 was disappointed to find that Illinois is much more conscientious 20 about adhering to the current guidance and previous IMPEP findings.

21 Another striking point is NRC's statement that the new 22 reg guidance was new, they shouldn't be held accountable for 23 statements made therein. Ninety-five percent of the items in the 24 guide have been around since the early 1990s and were found in 25

511 1 previous reg guides and brought to light by NMSS under the old 2 Agreement State audit program.

3 Now, you need to be listening, Larry. We're being 4 recorded, aren't we? I don't want any of this to be missed by 5 Larry. You can stay, Larry.

6 NRC never addressed in the report how it would document 7 and apprise the states of items in the guide it thought were no 8 longer important. The states should certainly be made aware of such 9 items so that they do not waste valuable man hours on these items, 10 such as recommended working life not being specified in the registry 11 sheet, updating old sheets, and bringing the total file up to 12 current standards when amending a registry sheet, and that they will 13 have documentation of the decision. This last item generated 14 feelings of regulatory bias from the manufacturers in the states 15 that are implementing this guidance in its entirety.

16 Now, the rest of this is pretty much my own, not much of 17 Gibb's. But I had some statements that I kind of made into 18 questions. But certainly in Illinois -- and I checked with Texas 19 and some others -- these are true.

20 My state has been told by NRC representatives to use a 21 checklist such as the ones shown at the NRC SS&D workshops as a 22 guide for reviews. Yes or no? And everybody so far I checked with 23 said, Yes, I've heard that from IMPEP reviewers and even before 24 that, in the old days, from Rich or Tom or somebody that had come by 25 to review our program.

512 1 The checklist is to serve as a guide to ensure no 2 important items are missed. I think we've all been told that. The 3 reviewer -- and this is prior to July of '98 -- the reviewer 4 checklist should be maintained in the SS&D file. I think we've all 5 been told that. So perceptions, opinions, and feelings regarding 6 this NRC SS&D program -- the IMPEP review is, Do as I say, not as I 7 do.

8 And one specific example there is following NUREG 1556 9 Volume 3. The answer shown to several of the reviewer's -- comments 10 was that didn't start until July of 1998, even though what we've all 11 been told is all of this guidance existed before. That was just 12 putting it all in one place. And that matches the training of the 13 workshops and stuff from previous years to that date.

14 That's what I said, but that's not what I meant.

15 Example: all items done to be satisfactory -- are to be 16 satisfactory -- that's the criteria -- versus it's 17 performance-based. And another example of that would be the 18 interpretation of the applicability of a concurrent review and what 19 is a concurrent review? Another perception is, That's new guidance 20 and we have not fully implemented it yet. An example is not 21 maintaining the reviewer checklist in the file.

22 And another one is, We have decided that item of 23 guidance in NUREG 1556 Volume 3 is not really necessary, so we don't 24 do it. Making sure the recommended working life was in a specific 25 section of the sheet was an example of that. There are other

513 1 examples of each one of these. And then the general feeling, once 2 again, that someone has a personal agenda to make us look bad.

3 Now, the bottom line to me is basically NRC went through 4 what a whole lot of us have. They went through a period and had 5 massive turnover in the SS&D program with maybe one of the old 6 timers left, and that was it. They had to bring a whole bunch of 7 new staff up to speed and they did an excellent job of doing it.

8 The team actually did not find anything that they could identify 9 that was a real public health and safety hazard or a potential 10 threat. There were some that there was some doubt on, because there 11 wasn't really enough of a paper trail to document that everything 12 had been reviewed, but they didn't find any real evidence of any 13 potential threat.

14 So for the technical quality of the evaluations, they 15 were found satisfactory but needs improvement. For the training and 16 qualifications, they were found satisfactory. And for the incidence 17 and whatever the rest of that subcategory is -- sub-indicator is, 18 they were found adequate. So the overall recommendation for the 19 program was it was satisfactory.

20 That's it.

21 MR. MARSHALL: Thanks. Let's go on to something on the 22 agenda I think is straightforward and I think good for where we're 23 headed, maybe next year. Let's deal with funding and logistics for 24 the local meeting --

25

514 1 MR. COLLINS: Oh. There was one other item I need to 2 bring up to make sure NRC doesn't -- it doesn't get interpreted in a 3 bad light.

4 There was a recommendation, which you may find in the 5 transcript if you look at it, that the next review of the NRC SS&D 6 program be two years rather than four. Most NRC regions get 7 reviewed on a two year cycle, plus the working group is making a 8 bunch of recommendations and NRC is proposing a bunch of changes to 9 the SS&D program. So the recommendation for a two year follow-up 10 for the SS&D program had absolutely nothing to do with any 11 recommendations or negative findings. Had nothing to do with that.

12 It's just because of all the changes that are about to 13 occur, we thought a two year cycle of going back was appropriate.

14 MR. MARSHALL: Ed?

15 MR. BAILEY: Floyd touched on an issue that Cindy had 16 mentioned earlier, a year or so ago when she was on a review team, 17 and that is that the NRC does not allow state people to review the 18 incident files. And I would think that what's good for the goose is 19 good for the gander, that we insist that only a state person review 20 our files.

21 MS. SCHNEIDER: Kathy Schneider.

22 I just want the record to show it's the allegations, not 23 the incidents. It's only the allegations files, Ed, and that's 24 because of the protection of the alleger.

25 MR. BAILEY: That wasn't what I heard. The incident --

515 1 MS. SCHNEIDER: No. It's only the allegation files.

2 It's always, always been the allegation files. It's not the 3 incidents. So that's the only thing that the state people cannot 4 look at is the allegation files for the NRC regions.

5 MR. BAILEY: Okay.

6 MR. SNELLINGS: I have a question. So what do we do 7 about this? I mean, we're all just sitting here looking at each 8 other. What happens now? Are these new ground rules? We busted 9 butt on IMPEP. Everybody else does. We follow the rules. So what 10 happens?

11 MR. GODWIN: I think the NRC is following what's now the 12 rules. They just didn't follow them as far as the prior stuff. But 13 they are complying, and I gather from the report that they got a 14 report that's basically satisfactory. So they're just waiting for 15 the next two years after -- and they're going to make some changes 16 in the meantime. They know that's coming.

17 That's the same thing that would happen to you if yours 18 was satisfactory. I presume somebody on the management wrote them a 19 letter saying, Thank you.

20 MR. COLLINS: It is my understanding from the conclusion 21 of the MRB meeting that NRC agreed to bring themselves in line with 22 what's currently written in NUREG 1556 Volume 3 until they actually 23 get the results of the working group and disseminate information so 24 that if there's backing off on any of the criteria, that everybody 25 can back off at the same time, in the same manner.

516 1 Does that answer -- isn't that accurate?

2 MR. LOHAUS: Yes. Paul Lohaus, NRC.

3 There's really two actions. The one is exactly as Steve 4 characterized. I think, given a number of the issues that were 5 identified in the SS&D reviews of the state programs, given the need 6 to look at the guidance and process -- there was an interest within 7 NRC to basically reengineer the process that NRC was using for its 8 SS&D review, and given the need to look at the criteria in the IMPEP 9 management directive 5.6, all this sort of came together.

10 And part of this was that we wanted to have the benefit 11 of the OAS review of our SS&D program. And the thought was to take 12 all of that information, including the results of the review, the 13 experience with the state reviews, and the reengineering, and 14 basically take a look at the criteria across the board. And out of 15 that working group should come recommendations relative to changes 16 to the criteria in the management directive, and I think one of 17 those is it's very clear that there's a need to make the criteria 18 more performance-based. One of the issues was the criteria were too 19 prescriptive. So that's one of the areas.

20 So I think out of that working group process should come 21 not only some areas for change in how we would do the SS&D 22 reviews -- and that can be reflected in the guidance -- but also 23 changes to our criteria in the management directive for the criteria 24 that we apply in doing the IMPEP reviews. And that would then be 25 applied uniformly across the board. But the second part of it --

517 1 that's sort of the first part of it -- the second part of it is, 2 similar to how a state would deal with an IMPEP review report, we're 3 going to handle that in the same manner.

4 The team did a very good job in conducting the review.

5 The report is issued in final. NRC has that. We are going to 6 address the comments and recommendations that are reflected in the 7 report and proceed forward to implement those within the program.

8 So those are really the two actions that I would see coming out of 9 this.

10 MR. MARSHALL: Thank you. Richard?

11 MR. RATLIFF: On the funding issue, as you know, we pay 12 our way now, and what worked well last year with New Hampshire, 13 we -- Diane had like $395 left over. So we started out with 395 14 seed money. We based the registration fee on what it was going to 15 cost us with that. We had to pay for the conference room, pay for 16 the breaks.

17 What happened just at the last week, there's a Texas 18 Health Foundation that I applied for a grant for, and so they have 19 awarded a grant of $1,200, which will pay our rooms. So we should 20 have about 6- to 800 more for seed money that we can send to the 21 next group. I think it will be helpful, because some of the things 22 that you really will have to look for is how are we going to keep 23 this money? I know my credit union with the Health Department was 24 real good. They let us set up a separate account -- sub-account 25 that's OAS and that do separate statements, so at least for this

518 1 year, until we transfer the money to the next host state, we have 2 good accountability.

3 I think it's going to really boil down in the long 4 term -- is what Kathy Allen said yesterday. And I think we really 5 need to hopefully assign a subgroup at this meeting to look at some 6 of the other issues and see is OAS a group that can get a tax 7 number, can get exemption status, and all those other areas? I 8 talked to Paul Lohaus earlier and NRC is still willing to provide 9 the microphones and the transcription. So the state will have to 10 provide the meeting rooms and the video: the slide projectors, 11 overheads, et cetera.

12 But I think we're doing well. Our registration fee is 13 pretty small, and we've got a good carry forward. What several 14 states had problems with is not having a tax number, and I think one 15 of the things is to look -- can you get a tax number without being a 16 501(c)(3) exempt status? But that would help a lot of the people, 17 and some of the states would have to go through and get checks 18 issued.

19 But I think the system -- since we're 31 individual 20 states that don't have a charter, don't have people with an office 21 that routinely do business, it will be more difficult to go through 22 the other route. But I think the meeting logistics works pretty 23 easily from a smaller state like Diane to a larger state. It's just 24 a matter of taking some time, and it's just dealing with the hotel.

25 The executive committee pretty much has worked with the agenda, and

519 1 so any state -- I know North Dakota, Ken, has suggested that they 2 might put in the bid. I think there's plenty of experience. I know 3 Diane and I have talked, and we're willing to work with Ken or 4 whatever state decides they want to host it next time to really go 5 forward.

6 I can keep the account for a year and so right before 7 next year's meeting I can transfer the money or I can transfer it 8 whenever they want to have it transferred to that state.

9 MR. MARSHALL: Diane?

10 MS. TEFFT: I think my concern last year was simply 11 accountability. I didn't have the option that Richard had in 12 putting it in a separate account. It was in my account, and I was 13 very nervous about that. I did get a secretary to go along and keep 14 track of this as well.

15 But I think over time, this just doesn't look good for 16 this organization, and I think we really need to pursue having some 17 sort of account that we can put our money into and then as we go 18 through the years, we can attach the costs of a meeting wherever it 19 is. So I really think -- recommend we do something about this.

20 MR. DUNDULIS: Richard, that brings up the point that 21 you raised yesterday about whether the secretary should become 22 secretary/treasurer and actually, in addition to the account, maybe 23 get one that we can draw checks should we have to. And it doesn't 24 have to be something that would withstand a CPA audit, but basically 25 like you do your own checkbook, and maybe as part of the business

520 1 meeting in future years, just a financial -- almost like an annual 2 financial report.

3 And even if we don't incorporate, Well, this is what we 4 had. This is what we took in. This is what we spent. And I've 5 worked with a lot of other organizations that have done it. And I 6 think all of the people that are involved are honest, but I think 7 that's the reason you feel so uncomfortable about the situation, 8 because you do have integrity but you're saying -- but what if 9 somebody says, I think there should be 33 cents more in the account 10 than there was? Then you'd probably be the one worrying about, Gee, 11 did I lose 33 cents?

12 MR. MARSHALL: Ruth?

13 MS. McBURNEY: One of the things that could be done is 14 if you did not want to go the 501(c)(3) route, which is the 15 tax-exempt organization, you could become a 501(c)(4), which is 16 scientific and professional, and at least get a number that people 17 could do their requests to.

18 MR. MARSHALL: Does that require the by-laws and the 19 incorporation paperwork and all that stuff too, or is it just simply 20 to get a number to be --

21 MS. McBURNEY: I think it does require by-laws.

22 MR. MARSHALL: It does? Okay. The point of this item 23 on the agenda was just to discuss and smooth out some of the highs 24 and lows of the last couple of years, since we're now paying our own 25 way. It's not -- we're not intending to take a vote or a motion.

521 1 We can if you choose to, but there's no real intent to spend all 2 night on this.

3 Aubrey?

4 MR. GODWIN: Just one quick comment. Didn't we assign a 5 committee to look into incorporation yesterday?

6 MR. MARSHALL: No. We mentioned it. We went as far as 7 mentioning it.

8 MR. GODWIN: I thought we asked that the board look into 9 it.

10 MR. MARSHALL: We can --

11 MR. GODWIN: And this could just be a part of that 12 look-see.

13 MR. MARSHALL: Sure.

14 MR. GODWIN: Just -- not spend any more time on it, just 15 look-see.

16 MR. MARSHALL: I can handle it.

17 MR. O'KELLEY: Stan, we came up with a great idea that 18 instead of incorporation we go for corporate sponsorship. If that's 19 the rule, we could have the Nike/OAS Agreement State meeting. We 20 were talking ooze earlier today. The swoosh might be a great 21 trademark. And Steve Collins' remark earlier, the logo, "Just Do 22 It" may fit this group real well. We've also had some discussion 23 with the Budweiser folks here, and they are interested in becoming 24 the official tritium-chelating agent for --

25 (General laughter.)

522 1 MR. O'KELLEY: So we see a lot of potential in this, and 2 it would ease all our money woes.

3 MR. MARSHALL: Thank you.

4 Right behind that topic is the next one, administrative 5 transition between chairman and chair-elect. This is kind of an 6 informational note. Roland, I think Bob Quillen for sure -- Roland 7 and I at least agree that being chair of this organization is very 8 different than it was even two-three years ago. Very different.

9 Very interesting, I will say from the experience so far. And I want 10 to make this a positive statement that being chair is a good thing.

11 It's been good for me. It's been a real interesting learning 12 experience, and I bring Ed along into the next year and the new 13 chair-elect that we will elect here yet this evening.

14 But I think we need to have a more sound and complete 15 orientation from past chairs. We need to involve OSP differently 16 than we have in the past. Roland indicates that he was blind-sided 17 a couple of ways becoming chair and then chair past, I guess, and 18 the same thing has happened to me. And I'd like to help next chair 19 persons to have a smoother time rather than be blind-sided, because 20 this cannot become a second career for somebody. There were times I 21 wondered. But I say this, I think if we hang together using past 22 experiences with host states, past chairman experiences, and connect 23 a little tighter with OSP on what NRC wants from this group, I think 24 this person can help all of you around the table to connect better 25 when they need working group support, when they need IMPEP and MRB

523 1 replacements. And it can make it -- I think keep it a very strong 2 relationship.

3 That's really all I wanted to say on that item.

4 I think before we do -- let's see. We've got three 5 resolutions. We've got two that we discussed and there's a third 6 one that has been worked up concerning support for the NRC budget.

7 While Roger passes that one out, I think I'd like to go back to the 8 first one we moved today. I think we distributed -- let me try to 9 recollect here -- we presented the Colorado GL exemption -- the GL 10 petition. Did we take action to move it to today?

11 MR. JACOBI: We tabled it until today. Right.

12 MR. MARSHALL: Okay. Let's address that one again.

13 MR. JACOBI: Let me just reiterate, in my mind, it's an 14 issue of equity between different licenses or some licensee is 15 required to meet our radiation safety standards and some exempt --

16 and it's also a question of needing to protect the public health and 17 safety. A rem is a rem is a rem, as Mike Mobley always used to like 18 to say. And therefore, if one licensee has to do a -- post a 19 radiation area and train its workers, then another licensee who has 20 exactly the same risks and same hazards should.

21 And I think it covered most of the things in my talk 22 there, and so maybe, Stan, you might like to say something, or else 23 if people have questions we can talk a little bit about it.

24 MR. MARSHALL: I don't know what happens or what causes 25 a mistake in posting in the Federal Register to reflect, in this

524 1 case, the organization instead of the officers for the organization.

2 I don't know who slurred that, but I reiterate that in May, I sign 3 on behalf of the officers only in support of the Colorado petition.

4 And generally, the resolution today is to bring all of you into the 5 loop if you so vote in support of the issue.

6 VOICE: Is that a motion to accept your resolution then?

7 MR. JACOBI: Yes.

8 MR. MARSHALL: Aubrey?

9 MR. GODWIN: I'd like to move that we accept the 10 resolution as presented by Jake.

11 VOICE: Second.

12 MR. MARSHALL: There's been a motion and a second to 13 accept the resolution as presented. All those in favor?

14 (A chorus of ayes.)

15 MR. MARSHALL: Let's discuss it more if you'd like. Is 16 there discussion?

17 (No response.)

18 MR. MARSHALL: I hear no discussion. All those in 19 favor?

20 (A chorus of ayes.)

21 MR. MARSHALL: Opposed?

22 (No response.)

23 MR. MARSHALL: It so passes. We'll work it up to put a 24 signature on it and date it today.

25

525 1 Okay. The other one was a -- there's a rework by David 2 Walter on the resolution to standardize something. I'm not going to 3 name it, because we beat that up a little bit.

4 Go ahead, David.

5 MR. WALTER: Okay. Have you passed them out yet?

6 MR. MARSHALL: One second.

7 MR. DUNDULIS: Since we officially tabled it, before we 8 start discussion -- I'll introduce a motion to remove it from the 9 table for further discussion.

10 VOICE: Second.

11 MR. MARSHALL: It's been moved and seconded to take it 12 off the table. What --

13 VOICE: It's automatic at the next meeting, it has to 14 come back up to be retabled or taken up.

15 MR. WALTER: Okay. Hopefully you have it in your hand 16 by now. If you don't, let me just -- okay. He's got them. I'm 17 going to go over the old one and tell you where the changes were 18 made, and that will probably help make it a little easier for you to 19 understand.

20 The title of it was changed to, Relating to 21 standardization of radiation limits to members of the public as 22 established by U.S. federal agencies. The next change is 23 typographical. On the last "whereas" on the first page on DOE order 24 435, that was just a matter of getting "except radon and its progeny 25 released to the air" and then close the paren.

526 1 On the back, the only other change that was made was in 2 the, Now therefore, be it resolved, which now has, "The Organization 3 of Agreement States urges the U.S. Nuclear Regulatory Commission, 4 the U.S. Environmental Protection Agency, the U.S. Department of 5 Energy and any other involved federal agencies to enter into 6 discussions which result in a consistent of radiation exposure 7 limits for all federal agencies. It is further recommended that 8 this limit be set at .1 rem, 1 millisievert per year total effective 9 dose equivalent."

10 MR. MARSHALL: What do you think?

11 VOICE: So moved.

12 VOICE: Second.

13 MR. MARSHALL: There's been a motion and second to 14 accept the resolution. Any discussion?

15 (No response.)

16 MR. MARSHALL: Arizona?

17 MR. GODWIN: Again, I would suggest the deletion of the 18 National Council on Radiation Protection publication 116 and the 19 International Commission on Radiation Protection publication 60. I 20 think you'll find that the National Council on Radiation Protection 21 is actually -- the correct name of the organization is the National 22 Council on Radiation Protection and Measurements. I've previously 23 stated why I think these should not be included, and I move to so 24 strike those from the first Whereas.

25

527 1 MR. MARSHALL: NCRP and ICRP -- those two. Has there 2 been a second to that motion?

3 MR. GODWIN: It appears, Mr. Chairman, I stand alone.

4 MR. MARSHALL: Illinois, comment?

5 MR. KLINGER: A question, actually. Is it a correct 6 understanding that the, Now be it resolved would counter the third, 7 Whereas about the patient release criteria of 500 millirem as 8 opposed to an exposure limit of 100 millirem? Is that a correct 9 understanding, because states that have already passed an equivalent 10 to 10 CFR 75 would basically be voting for a motion against their 11 own rules.

12 MR. WALTER: If you look at various situations that are 13 involved in all of these -- in some of these Whereas, the -- as a 14 for instance, the DOE and NRC both have a recommended limit of 25 15 millirem per year based solely on the fact that they are expecting 16 there to be multiple areas of exposure, and that they're actual 17 limit is 100 millirem.

18 And if you look at that on the third Whereas, it wasn't 19 necessarily my intention to do that because of the fact -- I don't 20 know what's going to happen on this as far as from the NRC's 21 standpoint, and I don't know that they would feel they would be 22 required to make a change because they already have specified a 100 23 millirem limit on virtually all of these things, with the exception 24 of the 500 millirem. It wouldn't keep them from giving specific 25 exemptions, but -- in my eyes it wouldn't.

528 1 But again, I have to say, like yesterday, and the same 2 thing that was said by Mike Mobley, a rem is a rem is a rem, and if 3 it's okay for someone to get a hundred millirem here, why is it 4 okay -- but only a hundred millirem, why is it okay for 500 here?

5 Why is it only okay for 25 here, and so forth? I'm trying to get 6 them to standardize it so that it's easier to understand, rather 7 than having -- if they standardize it and have 17 exemptions, that 8 kind of defeats the purpose.

9 MR. KLINGER: Right. The last paragraph says, a 10 consistent set of exposure limits.

11 MR. WALTER: Right.

12 MR. KLINGER: So I'm asking, is the understanding 13 correct that you would like it to be 100 millirem, and basically, 14 that would do away -- our recommendation would be to do away with 15 all of those others that are not that same --

16 MR. WALTER: For members of the general public. This 17 is -- the whole thing here is for limits to the members of the 18 public. Now, those are exceptional situations with patients. Okay?

19 They're members of the public but they're exceptional situations.

20 So in my mind, they could still go with that and be 21 within the context of this.

22 MR. KLINGER: Thank you. I thought that was what it 23 was.

24 MR. MARSHALL: Mel?

25

529 1 MR. FRY: I'm somewhat confused also with the last 2 sentence. You referenced whereas. In the different whereas is 3 various subsets, and yet you make recommendation back to the 100 4 millirem a year, which if you go back to the first whereas, is was 5 collective for everything, and it appears, as I read, that all the 6 limits, each and every one of them individually should not be set in 7 any lower than 100, but collectively they shouldn't be higher than 8 100. That don't make any sense.

9 MR. WALTER: The first whereas is talking about various 10 recommendations from groups throughout, whether they be federal, 11 including EPA, or international or national. That sets a precedent.

12 Or at least I'm looking at it as setting a precedent.

13 We set another precedent in our position paper that 14 specified that 100 millirem was what we recommended. I'm following 15 through on that position paper and recommending 100 millirem.

16 MR. FRY: Then I think we need to clarify what we mean, 17 that the limits be set at 100. The implication there to me is that 18 you shouldn't ever parcel it out, and I don't agree with that. I 19 think there are good reasons for parceling it out. I certainly 20 concur in the national-international recommendation of the total 21 being 100.

22 MR. WALTER: That's why the total --

23 MR. FRY: But the issue is how to parcel is out, and 24 that -- and you don't have agreement on. I happen to think that the 25 government promising me clean water is a much higher standard than

530 1 letting my wife come home with some seeds inside of her. I wouldn't 2 consider those to be anything equivalent with each other. I don't 3 disagree with the whole overall idea that the total general public 4 shouldn't be exposed to any more than 100 millirem a year, but I 5 sure don't want my government supplied water to do that to me.

6 MR. MARSHALL: Pearce and then Jake.

7 MR. O'KELLEY: Maybe I'm lost too. I thought I knew 8 what this meant.

9 But I do -- I'm of the opinion that I think that it 10 ought to be at 100, even for this new Part 35 release criteria. I 11 don't see why that should be taken any -- or receive any 12 consideration other than any other source. And I think the bottom 13 line is what we're trying to do here is just set a tone for what we 14 people think is going to -- or what we want to do, because I don't 15 think it's going to really matter. They're not going to adhere to 16 it and they're not going to automatically go out and say, Okay.

17 They said do it so we're going to do it.

18 But I think what we're just trying to do is set the tone 19 of what the feel of this group is. If we get bogged down in 20 semantics all we want --

21 MR. MARSHALL: Jack?

22 MR. JACOBI: I think I agree and wanted to say what Mel 23 had said, that I don't have a problem with that collective limit for 24 all sources of exposures to a member of the public should not exceed 25 a millisievert. But I'm not sure that we really want to say

531 1 eliminate all fractionization so that your low level waste, your 2 uranium mills, and your D&D from your licensees are each set at 100 3 millirem rather than fraction it out. Or maybe you did and I'm 4 misunderstanding it, but I assumed that you didn't.

5 But the way it reads is you say, Well, you have a 25 6 millirem limit here, and therefore we think it should be 100. So I 7 think if it's not the intent that you eliminate the fractionization, 8 it has to clearly state that.

9 MR. WALTER: That's the reason I put in total effective 10 dose equivalent rather than a fractionated dose or anything like 11 that. I expected that to be the overall maximum that they were 12 looking at as the standard they would set.

13 And so a change in the wording there for collective, if 14 that makes it more clear -- anything that would make that much more 15 clear to you, then absolutely.

16 MR. DUNN: I move to amend the resolution to add to the 17 very end of it the words, to members of the public. I know it's in 18 the title, but that's just for clarification. I think it would help 19 some.

20 MR. DUNDULIS: Second.

21 MR. MARSHALL: It's been moved and seconded to add the 22 words, to members of the general public.

23 MR. DUNN: I don't think the word general.

24 MR. MARSHALL: Well --

25

532 1 MR. DUNN: Just to members of the public is the wording 2 consistent with current regulations.

3 MR. MARSHALL: All right. To the last line of the, now, 4 there it be resolved, paragraph. Any discussion? Stan?

5 MR. DUNN: That's fine with me. So you wouldn't even 6 have to vote on it if I say it's okay.

7 MR. FITCH: I'm not real comfortable with this idea of 8 including Part 35-75 in here because of the fact that if we start 9 popping it down to 100, that's going to be a little too restrictive.

10 That's not really taking into account people -- patients and their 11 families, and show more compassion there of allowing a little bit 12 higher dose.

13 I'm really not comfortable with having it in there. I'm 14 not going to move that we strike it out. Somebody else can do that, 15 but I just don't like the idea.

16 MR. MARSHALL: Other discussion?

17 MR. O'KELLEY: Do you want to handle these individual 18 word changes as they are or you want us to keep making suggestions 19 and vote on them all together, because I like the idea of putting 20 the word collective in there somewhere, probably like this 21 collective limit. Maybe that's the place to stick it.

22 MR. MARSHALL: To which place?

23 MR. O'KELLEY: I'm on the next to the last line, 24 "Further recommend that this collective limit be set."

25

533 1 MR. WALTER: I'll add that and I'll say that and then 2 I'll speak against the whole concept, because what you have just 3 said is we want it all, and I think we all agree that it ought to 4 collectively be 100. But I started to 500. I support that --

5 comment the 4 millirem for drinking water, I support that. I'm 6 sorry, girls. I don't like everything from everywhere being all one 7 number. I think it's a rotten idea.

8 MR. FRY: Point of order. There's a motion on the floor 9 still.

10 MR. MARSHALL: Arizona?

11 MR. GODWIN: Since apparently we're discussing all the 12 issues at one time instead of just the last little amendment, I'd 13 like to point out that if you make this collective change or if you 14 view it as David as indicated, you really hadn't changed anything 15 because they'll look at it and say, Hey, we're all within a hundred.

16 We're okey-dokey. You haven't changed anything. We're passing this 17 resolution. Then we come to, Why are we doing it then? What we 18 really ought to be talking about, is there a limit we want to have 19 for each one of these and see what our parceling out would be? And 20 I don't think we're really prepared to do that in 30 minutes this 21 afternoon.

22 It's a good idea to say we want the same limits for 23 water and the same limits for this and the same limits for that, and 24 whatever number we choose for each of those media, but when you 25 really get down to it, just setting the overall collective limit of

534 1 100 millirem is not going to do anything to change one federal 2 agency action, because if everyone kept it within 100 millirem and 3 they're saying, This is what we think the parcel ought to be.

4 And if you look at it collectively, which is what I 5 believe we've been discussing, that this 100 millirem is a total 6 collective dose, then I would suggest to you it's worthless to pass 7 this because they're all going to beat it. And they're going to 8 say, Oh boy. We've got all support from the states.

9 I'm sorry. I just don't believe we're going to gain 10 anything if we go that direction.

11 MR. SNELLINGS: I'm absolutely confused. The last 12 sentence, does that mean that to me, as a member of the public, I 13 should not receive greater than 100 millirem from all of these 14 various sources that we have whereas-ed up here? Is that how we're 15 interpreting that? We haven't really done much of anything.

16 MR. GODWIN: That's my understanding.

17 MR. SNELLINGS: I agree totally with Aubrey. We haven't 18 done anything.

19 MR. MARSHALL: Pearce?

20 MR. O'KELLEY: I was going to make originally the same 21 point Aubrey did. We're still advocating these various dose limits 22 depending on whether you're millirem comes from water or whatever, 23 and if somebody in this room can tell me where a water millirem is 24 more dangerous than any other millirem, then I'll be happy to 25 support four millirem a year. And if somebody can also tell me that

535 1 the extra 400 millirem that these family members are going to get 2 from these medical releases are not harmful, then I'll support that 3 too. But I don't think there's anybody in this room that can 4 justify the differences.

5 MR. MARSHALL: New York?

6 MR. BAKER: I think we should move to table this whole 7 idea. All these limits have been set based on some numbers that 8 were based on some risk, and while they may not all be consistent, 9 they shouldn't be based on 100 millirem. And maybe ultimately 10 that's a number to consider, but they should be based on some risk, 11 some recommendation the EPA comes up with, whatever. But I move to 12 table this discussion.

13 MR. JACOBI: Second.

14 MR. MARSHALL: Discussion? Am I wrong? Don't we have a 15 motion and second with discussion to pass? Somebody tell me. This 16 relates to the chair, chair-elect transition. I need a 17 parliamentarian or an education in rules of order, because you're 18 frustrating the heck out of me.

19 MR. BAILEY: Point of order. I think -- didn't we go 20 through this before that if we table it at this meeting, it dies at 21 the end of this meeting because we only have annual meetings? So if 22 you want to table it now and you don't bring it up before we leave 23 here, it's dead for this year but can be reintroduced next year?

24 VOICE: Correct.

25 MR. BAILEY: So I call the question.

536 1 MR. O'KELLEY: Which one? There's four on the --

2 VOICE: The motion to table takes precedent --

3 MR. BAILEY: That's right. And I'm calling the question 4 on the motion to table.

5 MR. MARSHALL: All those in favor?

6 (A chorus of ayes.)

7 MR. MARSHALL: Opposed?

8 VOICE: No.

9 MR. MARSHALL: It passes to table it. Okay. Did we get 10 through this one, Roger?

11 MR. BAILEY: Mr. Chairman, do we have any guidance that 12 came out of that discussion on whether or not there should be an 13 attempt to carefully craft such a motion for next year's 14 consideration?

15 MR. DUNN: Is that a motion?

16 MR. BAILEY: No, it's a question?

17 MR. O'KELLEY: Well, can we discussion that or has 18 discussion been shut off on that too?

19 MR. MARSHALL: I would say the leadership that we elect 20 can lead and direct the organization any way -- I don't think this 21 group has any direction on this matter to provide.

22 MR. BAILEY: And this organization already has a 23 position paper on this.

24 MR. GODWIN: I would point out to the chair, you could 25 wait until everybody leaves and then find out if somebody will make

537 1 a motion to take it off the table, take it up, and vote it down if 2 you want to.

3 MR. MARSHALL: All right. Do you want to do this, 4 Roger?

5 MR. SUPPES: Yesterday we discussed providing support 6 for the NRC budget that -- I think Greta Dicus had had dinner with 7 the executive committee and had requested the assistance of our 8 organization in providing support to NRC for non-license fee based 9 fund from Congress to support activities of the Agreement State 10 program. And at yesterday's meeting, I volunteered to take a stab 11 at putting together a draft resolution.

12 The resolution that you have before you attempts to deal 13 with that. Another aspect of the resolution is also urging each of 14 our states to provide support to -- and information to members of 15 Congress along this line, because the feeling that was expressed at 16 the meeting yesterday was that it's not only support of 17 organizations like ourselves but individual support from our 18 respective states that is also heard, and may be even more 19 effectively heard by members of Congress.

20 So the -- one thing I wanted to point out -- and this is 21 a -- it remains a question -- it was my understanding that some 22 portion of the NRC budget is general revenue fund based, or whatever 23 the appropriate term is, for their international programs. And the 24 third whereas says that's the reason it says almost exclusively. I 25 haven't -- that was information I had. I've talked with a couple of

538 1 folks from NRC, and they were not certain of the source of funding 2 for the international programs or whether or not -- another aspect 3 of that was that funds had been transferred from the State 4 Department to NRC for support of international programs.

5 So I think that's the reason why I used the word almost 6 exclusively. I don't know whether that is a cause -- how much of a 7 cause for concern that is, yet I also did not provide any amount 8 because I thought that this resolution would provide NRC with the 9 maximum flexibility. They know what they need. This is an 10 indication of support for them. It does say that this resolution 11 supports activities associated with the Agreement State program.

12 It's not directed, nor would it be an appropriate use of the 13 resolution to say for other things like their international program 14 efforts. The resolution doesn't speak to that.

15 So that's what the attempt was, was to draft a 16 resolution that encourages Congress to provide NRC with additional 17 funds to deal with the issue that, as more and more Agreement States 18 come into the fore, there's less and less of a fee base for NRC to 19 ship -- or provide a base for their costs. So that's what the 20 resolution's trying to do, is to get Congress to recognize that 21 there are other activities out there. There are things that should 22 be supported by general revenue funds and not limit the budget of 23 NRC to that they derive from their licensees.

24 MR. O'KELLEY: I move the motion be passed.

25 MR. FRY: I second.

539 1 MR. MARSHALL: There's been a motion and second to pass 2 this. Discussion? Arizona?

3 MR. GODWIN: I think it's a very good resolution and 4 support its passage. However, I think there's a couple of little 5 improvements that might can be made in the, I guess fifth whereas.

6 If you'll follow the changes. Whereas, the Commission has requested 7 that Congress provide additional non-licensee -- add the word fee 8 based funds to support -- change the word the to these --

9 initiatives of the Commission and Agreement States.

10 It would then read, "Whereas the Commission has 11 requested that Congress provide additional non-licensee fee based 12 funds to support these initiatives of the Commission and Agreement 13 States." I move that change as an amendment.

14 MR. DUNDULIS: I second that.

15 MR. MARSHALL: Moved and seconded to make those changes.

16 MR. FRY: Again, do you want to approve the changes one 17 at a time, or do you want to look at more than one? There are some 18 budget initiatives of the U.S. Nuclear Regulatory Commission I 19 haven't even seen. I would guess, knowing who I am, that on the 20 last line I don't support all of their budget initiatives. This 21 budget initiative, singular, maybe?

22 MR. GODWIN: I think that -- I said these initiatives, 23 speaking specifically by the ones in the preceding whereas, which is 24 infrastructure, training, and coordination.

25

540 1 MR. FRY: I agree with what you changed. I'm now on the 2 last line of the whole resolution where it says, I'm in favor of all 3 the NRC's budget initiatives -- and I doubt that I am.

4 MR. GODWIN: Could we add the word these budget 5 initiatives --

6 MR. FRY: I put this budget initiative. This one we're 7 talking about.

8 MR. MARSHALL: Does everybody understand that? The last 9 resolved, change the word in the first line, the, to these?

10 MR. COLLINS: To this. And take off the s on 11 initiatives.

12 MR. MARSHALL: Initiative, singular.

13 MR. COLLINS: Am I the only one that thinks provide 14 additional non-licensee fee based could carry the connotation that 15 you're suggesting that they have some more fee based, as opposed to 16 GRF? That could be misinterpreted.

17 MR. GODWIN: I think the first resolved takes care of 18 that, because we talked about non-fee based general funds that are 19 used to support -- suggest they receive non-fee based general funds.

20 I think that addresses the issue you're trying to raise.

21 MR. COLLINS: Yes. I guess what I'm really suggesting 22 is in the whereas where Aubrey suggested most of the changes, that 23 you might ought to put the word general in front of funds.

24 MR. MARSHALL: Stan?

25 MR. FITCH: How would it read?

541 1 MR. DUNN: The last whereas would be, "Whereas the 2 Commission has requested that Congress provide additional 3 non-licensee fee based general revenue funds to support these 4 initiatives of the Commission and Agreement States."

5 MR. FLETCHER: I thought we said that we were changing 6 it to this initiative.

7 MR. FRY: Well, we did in the resolved but we didn't in 8 the whereas.

9 MR. FLETCHER: Okay. But the second -- if we want to 10 save some time, if the originator would accept the changes, we don't 11 have to go through voting.

12 MR. FRY: What I propose -- if I understand up in what 13 Aubrey was changing, that we're talking about a number of different 14 initiatives that might be evolved, and therefore it should be plural 15 under the last whereas. But on the last line, my proposal was to 16 read, "The Organization of Agreement States urges its individual 17 member states to support this budget initiative." "This budget 18 initiative" covers all of those initiatives that would involve 19 general funds.

20 MR. MARSHALL: Is that understood and is that agreed?

21 Let's vote.

22 MR. DUNDULIS: Would we want to say, the above-mentioned 23 initiatives?

24 VOICE: Call the question.

25 MR. MARSHALL: All those in favor?

542 1 (A chorus of ayes.)

2 MR. MARSHALL: Opposed?

3 (No response.)

4 MR. MARSHALL: This passes too.

5 MR. FRY: Mr. Chairman, I would remind the states that 6 what they did, they've told themselves to go write some letters to 7 Congress, and I would urge you to do as much as you can along those 8 lines.

9 MR. MARSHALL: Yesterday we brought up -- I brought up 10 the concept of secretary-elect, and we talked about bringing that 11 person in a year before the expiration of the current secretary and 12 also changing the term, including that year as secretary-elect so 13 there's only three, not four, years involved for the secretary: one 14 year as secretary-elect, two years as secretary. Is there any 15 interest to do this?

16 MR. FRY: That was the very issue I made, Stan, when I 17 said let's go ahead and vote and do it, and then send you home to 18 try to find somebody to nominate. We can do it again. I think 19 somebody just made a motion to do it again.

20 VOICE: It's been motioned and seconded.

21 VOICE: It's already been voted.

22 MR. MARSHALL: All those in favor?

23 (A chorus of ayes.)

24 MR. MARSHALL: Anybody opposed?

25 (No response.)

543 1 MR. MARSHALL: All right.

2 MR. DUNN: Mr. Chairman, I nominate Alice Rogers for 3 this position.

4 MR. MARSHALL: Does Alice accept the nomination?

5 MS. ROGERS: Yes.

6 MR. O'KELLEY: Second.

7 MR. MARSHALL: I think you're it. Let's pass around 8 this form then. Do you want to do this?

9 VOICES: Yes.

10 MR. MARSHALL: All those in favor?

11 (A chorus of ayes.)

12 MR. MARSHALL: Anybody opposed?

13 (No response.)

14 MR. MARSHALL: Okay.

15 VOICE: Can we go ahead and vote?

16 MR. MARSHALL: We just did.

17 VOICE: Point of order, Mr. Chairman. Is the board 18 awake up there?

19 (General laughter.)

20 MR. BAILEY: The motion was to close nominations.

21 That's what we voted on.

22 VOICE: Right. But only one candidate.

23 MR. BAILEY: It doesn't matter. You still have to vote 24 on that one candidate. I call the question.

25

544 1 VOICE: I make a motion that the secretary cast one vote 2 for the secretary-elect.

3 VOICE: Second.

4 MR. MARSHALL: Those in favor?

5 (A chorus of ayes.)

6 MR. MARSHALL: Those opposed?

7 (No response.)

8 MR. MARSHALL: I'm trying to send around a form that has 9 your two nominations for chair-elect, and the one -- and you can add 10 Alice Hamilton Rogers --

11 VOICE: No. That's not necessary.

12 MR. MARSHALL: Okay. I want to explain something.

13 There were 31 ballots prepared. I believe -- is Kansas here?

14 VOICE: No.

15 MR. MARSHALL: Is Iowa in the room?

16 VOICE: No.

17 MR. MARSHALL: Okay. There should be two ballots then 18 not used. I'd like two volunteers to count the votes, not on the 19 board. Marsha.

20 (Pause.)

21 MR. MARSHALL: Somebody else to help Marsha count these 22 ballots? Ken Weaver? We'll let everybody up here rest.

23 (Pause.)

24 25

545 1 MR. MARSHALL: While they count that, I'd like to move 2 to the next item that is, I think, except for Aubrey's question --

3 do you still want to address your question, Aubrey?

4 MR. GODWIN: Yes, sir. I would. Whenever you're ready.

5 MR. MARSHALL: Let's wait a minute, because I have no 6 idea what your question is. I'm trying to regain a little bit of 7 control here, whatever that means.

8 Year 2000 OAS meeting location -- Ken from North Dakota 9 had previously offered to host our meeting.

10 MR. GODWIN: I move we accept that offer.

11 MR. JACOBI: Second.

12 MR. MARSHALL: Does Ken have any discussion?

13 MR. WANGLER: I don't know that I'm really one way or 14 the other on this. When I threw it out, I was just checking the 15 water. I didn't know that I was going to get nominated so quickly, 16 so I can sympathize with you, Alice. I know how this feels.

17 But my only thoughts are, just so you understand the 18 logistics, when I first went to get a plane ticket down here, it was 19 $900 plus, and that was without a Saturday night stay over. And I 20 know we voted before our talked before, at least about the Saturday 21 night stay over requirement. It's not very favorable with most 22 people. But let me give you the good side of the story.

23 When they added the TENORM discussion on, it forced me 24 to stay over Saturday night because the connections are not good 25 enough for me to get home Saturday night anyway, so I have to go

546 1 home on Sunday. It will take me all day to get there. We leave at 2 6:30 and get in at 3:30. But the plane fare dropped $500 to 400 and 3 whatever it was, and then they had a special going on, so 385 was my 4 plane fare down here. But I don't know how many of you can expect 5 to get that kind of discount from $900.

6 So understand that we've got -- we're served by two 7 airlines. It's a town of 50,000. I'm sure we can handle a meeting 8 this size. I don't have any problem with that. But it's probably 9 going to be a little bit tight getting in. I don't know how many 10 flights a day come in, half a dozen? Northwest and United 11 Express -- so the one out of Denver is a prop. There is a jet.

12 There's a 727 that flies once in a while, but a lot of times it's 13 one of those flying cigar tubes, those prop planes coming up from 14 Denver. Northwest is out of Minneapolis.

15 MR. O'KELLEY: Can you give Honolulu your proxy?

16 MR. GODWIN: Nothing says they have to be hosted in that 17 state. You might want to host it somewhere else.

18 MR. WANGLER: No. I'm not going to host it anywhere 19 else. I've got reservations about doing it in Bismarck. But that's 20 fine.

21 I keep getting these, I want to go to North Dakota just 22 because I've never been there, kind of thing, so whatever. So if 23 you want to have it in North Dakota, that's fine. I'm more than 24 willing to give it up to somebody else, if -- all you've got to do 25 is get your hand higher than mine.

547 1 MR. MARSHALL: Seeing no one do that, I think we're all 2 inclined to go to North Dakota. Do we need to vote on this?

3 MR. WANGLER: The only other thing -- do it in 4 September. I know Stan and I have already talked about this. Don't 5 push it back to October. Do it one of the three weeks in September, 6 not including Labor Day weekend. And so between right now and up to 7 the last week of September would be a good time to get it done.

8 MR. COLLINS: Did I hear a motion that it close for 9 that? I was told that Illinois is willing to host again in the 10 Chicago area, so I'm throwing that out?

11 MR. MARSHALL: Next year or 2001?

12 MR. COLLINS: Yes. Now, I am not pushing ahead of North 13 Dakota. I'm just -- I said very carefully, I was told Illinois was 14 willing to host.

15 MR. O'KELLEY: Are you taking requests for two years 16 down the road, because we may be willing two years down the road. I 17 don't want to take North Dakota's turn.

18 MR. WANGLER: Let me tell you what my biggest 19 reservation is. My biggest reservation is the amount of effort that 20 I'll have to put into putting this thing on. There's myself and two 21 others, and I also manager four other programs, so basically it's 22 about 2.3 people to put this one. So that's really where my 23 reservation comes from.

24 And in fact, Dana Mount [phonetic] -- a lot of you 25 already know him -- cautioned me on this. He said, Do you really

548 1 think that you can pull this off? And the answer to that is yes, 2 but I don't do it with my eyes closed. That's why if somebody else 3 wants to take it -- I'm sure Illinois can do -- well, Illinois 4 doesn't have to expend the percentage of personnel effort to put 5 this on that we do.

6 But whatever -- and I don't care how you go about 7 deciding and you're not going to hurt my feelings. I'm not a person 8 that goes out looking for work. I've been in the military. I know 9 what it's like to volunteer. I'm sorry that I -- I question why I 10 ever said, Gee, maybe. So I should have known better than that. I 11 must have had a slip that day.

12 MR. FITCH: Tell us about North Dakota accommodations.

13 MR. WANGLER: Outhouses and no running water. Wagon 14 train in. Your accommodations will be fine. There's a couple of 15 places that could host a meeting this size. I don't know what you 16 mean by accommodations. You'll have a room with bed in it, running 17 water and -- I told you about the airlines in and out. Out is 18 probably easier than in because I suspect there will be some tag ons 19 at the end of that meeting also, so not everybody will want to leave 20 at one time.

21 MR. MARSHALL: At this time, all those in favor of North 22 Dakota, say aye.

23 (A chorus of ayes.)

24 MR. MARSHALL: Opposed?

25 VOICE: No.

549 1 MR. MARSHALL: I think it passes. At this time, let's 2 plan for North Dakota September of next year.

3 MR. RATLIFF: Ken, if you'd like, we can keep the 4 account I have open until then and transfer it right beforehand.

5 MR. O'KELLEY: Question, Stan.

6 MR. MARSHALL: Okay.

7 MR. O'KELLEY: When do you formally volunteer for the 8 following year? Is there a time --

9 MR. MARSHALL: You can do it now.

10 MR. O'KELLEY: Well, I'll put Charleston up against 11 Chicago.

12 MR. MARSHALL: We'll put those two on the list for Ed.

13 We'll put those two on the nomination.

14 Aubrey, do you have a question?

15 MR. GODWIN: I have a suggestion. I believe you are 16 having a meeting with the Commission or the chairman or the 17 Commission coming up in October?

18 MR. MARSHALL: Yes.

19 MR. GODWIN: And I would like to suggest that Part 35 20 versus Part G be part of your discussion, and I would suggest and 21 offer a motion that we ask the board of directors to write a letter 22 stating that there is an inherent -- there's not inherent safety in 23 the Seaman's proposed general license distribution, their portable 24 device, and that also be a part of their -- and refer them to the 25 letters that have already been sent by the states. And let's just

550 1 be a sense of the organization that we recommend that it's not 2 inherently safe. And not a resolution, just a sense that the 3 organization -- that it's not inherently safe, and refer them to the 4 letters that have already been sent by the states relative to this 5 matter.

6 MR. MARSHALL: The board will take that into 7 consideration and make that contact for such --

8 MR. GODWIN: And of course put that [indiscernible].

9 MR. MARSHALL: Yes. Thank you.

10 Is there anything else? I have an election result.

11 Kathy Allen is your new chair-elect.

12 (Applause.)

13 MR. MARSHALL: Roland?

14 MR. FLETCHER: Just a reminder, and perhaps we can do 15 this by e-mail. I do have one additional person for IMPEP. But we 16 still need two -- at least two additional IMPEP representatives with 17 experience in SS&D and we need to begin rotating some of the people 18 off of the MRB, because most of the people there have done five or 19 more MRBs. So we need to -- Shawn Seeley has volunteered for the 20 IMPEP team, and we're still looking for others. Bob, you have 21 someone who -- good.

22 Give me the name and I'll pass it on. Thank you.

23 MR. MARSHALL: Is there any other business? Ken?

24 MR. WANGLER: This is probably counter to what my 25 concern is here, but we're now going on after seven o'clock. These

551 1 meetings traditionally get like this because they're not run well 2 somewhere in the beginning, and we can look back to today and see 3 that the -- we fell off schedule on the very first session this 4 morning. We were set back at least 45 minutes by the end of the 5 first session.

6 Now, I guess -- at the CRCPD meeting, one of the things 7 I appreciated, even though it's a little bit disruptive to the 8 speakers, is they knew the time they were supposed to have finished 9 and then they were told to finish at that time, and not having 10 finished, they were cut off. But it kept things on schedule. One 11 of the complaints we've had out of this group in the past is we are 12 the OAS and our meeting is always put back on the back burner. I 13 mean, we started this meeting when we were supposed to be finished 14 with it.

15 And so I don't know exactly how to handle this, but my 16 question would be when we started this morning, did the people know 17 at eight o'clock that -- we had three of them to go through -- how 18 long they were going to speak, and did Chip know how long they 19 expected their topics to last so that we could be done and start the 20 next session by 9:15?

21 MR. MARSHALL: They may not have individually known as 22 well as they could have, and that is a detail that we're going to 23 pursue a whole lot better next year.

24 MR. WANGLER: Good. That's all I ask, that we don't --

25 yesterday we did real well. Today we didn't do very well. So we

552 1 should try better to stay on schedule, whatever that takes. And my 2 suggestion would be that each speaker knows how long they have, so 3 that they prioritize their discussion to fit it within that time.

4 MR. MARSHALL: Can I adjourn this meeting? All those in 5 favor?

6 [A chorus of ayes.]

7 MR. MARSHALL: Thank you.

8 [Whereupon, at 7:07 p.m., the meeting was recessed, to 9 reconvene at 8:00 a.m., Friday, September 10, 1999.]

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