ML20205K925
| ML20205K925 | |
| Person / Time | |
|---|---|
| Issue date: | 03/05/1999 |
| From: | NRC |
| To: | |
| References | |
| ASB-300-682, NUDOCS 9904140059 | |
| Download: ML20205K925 (90) | |
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UNITED STATES OF AMERICA 2
NUCLEAR REGULATORY COMMISSION 3
4 POTASSIUM IODIDE (KI) CORE GROUP MEETING 5
6 AmeriSuites Hotel 7
1520 West Baseline Road 8
Tempe, Arizona 9
Friday, March 5, 1999 10 11 The above-entitled meeting commenced, pursuant to 12 notice, at 9:00 a.m.
13 14 PARTICIPANTS:
15 ABY MOHSENI, CHAIRMAN 16 ED WILDS 17 JEAN TEMECK 18 BILL Mc W 19 MARCIA CARPENTIER 20-JIM HAREDMAN 21
'ANDY SIMPSON 22 AUBREY GODWIN 23 JOELLE KEY 24 MIKE CASH 25 TONY SHERIDAN l
()
7084 RILEY & ASSOCIATES, LTD.
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PARTICIPANTS:
[ Continued]
2 MIKE NAWOJ 3
ANDREA PEPPER 4
MIKE JAMGOCHIAN 5
6 7-8 9
10 11 12 l
13 14 O
15 16 17 18 19 20
.21 22 23 24 25 j
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PROCEEDINGS
)
2
[9:00 a.m.)
3 CHAIRMAN MOHSENI:
On the record.
Continue.
4 MR. SIMPSON:
I think a number of us are concerned 5
about the quality of the data that comes out of Chernobyl 6-and perhaps, I don't know that this is possible but perhaps 7'
we can ask that the FDA pursue that data in a rigorous 8
scientific way looking for original data, going to original 9
sources, not just the published literature, to look at that 10 differently than it seems they have looked so far.
11 In addition, that they include the Selafield (ph) 12 and the Marshalls and all the other -- Windscale which is 13 Selafield, sorry, all of those in their studies.
It may be 14 necessary that they publish something quickly regarding or O.
15 more quickly regarding the neonates but I would prefer that 16 they take the time necessary to do a proper scientific study 17 and not just rely on the existing published data that comes 18 out of Chernobyl because it appears to be inadequate to make 19 these kinds of decisions.
20 MR. HARDEMAN:
I wholeheartedly concur, well, 21 spoken.
22 CHAIRMAN MOHSENI:
Good morning, everyone.
23 MR. SIMPSON:
Well, you asked, Aby.
Don't want, 24 don't ask.
l 25 MR. McNUTT:
I would suggest that we ask them to
()
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F i
l 754 l.
1 go beyond what just what they've done so far.
It's going to
'()
take a considerable length of time and I think it's going to 2
3 be your responsibility to approach the Commission because l
they're looking for a certain time frame to get this report 4
5 out.
I don't think it should be completed until we have the I
6 type of information that we're relying on FDA to provide us.
/
7 MS. KEY:
That or we'd have to base it on the
'82.
j 8
MR. HARDEMAN:
Yeah, we discussed that yesterday 9
and my personal feelings are that it's really inappropriate 10 for us to come out with a final document knowing full well 11 that FDA is reviewing its guidance.
And until we've at 12 least seen the -- well, until we get the final guidance out 13 of FDA, anything that we would do here would have to have a 14 big, you know, interim use stamp on it.
And we'd probably 15 have to reconvene after FDA guidance becomes final to go 16 through all this again.
17 MR. GODWIN:
There is sort of a middle line 18 position that could be taken.
If we find out that the FDA i
19 is indeed going to take two to three years to do this, plus 20 perhaps an extended comment period after they go to the 21 Federal R(gister, we could take the position that, okay, 22 we'll go final with this based upon the '82 position of the 23 FDA and go with that.
24 And then at the time that FDA goes final with new 25 guidance then leave it up to the Commission to decide what ANN RILEY & ASSOCIATES, LTD.
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they want to do about the new guidance.
You know, we can O(_)
2 proceed on that basis.
Say, "Okay, FDA says they're going 3
to be three years down the road.
You want a document, we'll 4
give you a document", but by law basically we would have to 5
follow the FDA existing guidance.
6 CHAIRMAN MOHSENI:
What about the concern you 7
expressed about the dosage for neonates?
8 MR. GODWIN:
Well, yeah, I don't think we can 9
address that issue.
FDA has got to make that decision.
If 10 the FDA puts out a rush notice on that area alone, then we 11 adjust the document to address that.
But, you know, and 12 they may if they decide they're going to take a long time.
13 They may go ahead and do that.
14 But if they don't, I think we're stuck with having
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15 to follow the official U.S. guidance which is safe and 16 effective at 25 rem, 65 milligram doses.
17 MR. HARDEMAN:
But I think we also at least have 18 to put a note in there for the neonates, that, you know, 19 that this could lead to transient hypo-thyroidism, you know, 20 all the various effects and you know, we can just note that, 21 but I don't know that we can, you know, make any 22 recommendations.
23 MR. GODWIN:
We would ask FDA to put a note like
'24 that.
25 MR. HARDEMAN:
Certainly I'm concerned but I don't l
)
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I l
756 1
1 know as we would have the wherewithal to do that.
It would
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2 still have to come from FDA.
3 MR. GODWIN:
We'd ask FDA to put it in their 4
section.
5 MR. McNUTT:
We can certainly make sure that's 6
emphasized in the emergency plan.
7 MR. SHERIDAN:
Are we just doing pros and cons?
I 8
mean, basically we're not making any decisions.
So I can 9
just suggest that -- I could suggest that we just say that
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10 this is something that needs -- you know, this is -- you 11 know, the information-is inadequate.
We need to have -- I 12 don't see how this should delay the document at all except 13 for the neonates maybe.
14 MR. HARDEMAN:
Maybe to kind of get us out of this 15 box, maybe kind of modify what Bill said and what you 16 recommended, Aubrey, and that's have Aby go back to the NRC l
17 and present -- to the Commission and present them with 18 basically these two or three options.
You know, "Here's i
19 where we are, we're at a fork in the road.
We can either go 20 this way and base the document on existing 1982 FDA guidance 21 or we can let FDA do their thing, however long it's going to 22 take and then put together our final document and there may 23 be another -- there may be a third or a fourth option in 24 there.but I think it's kind of presumptuous of us to make 25 that decision.
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n 757 1
I think we should just lay out the options and let
()
2 the Commission look at it and see which way thay wish us to 3
proceed.
4 CHAIRMAN MOHSENI:
Let me ask you, are we 5
concerned about the time schedule of FDA because FDA 6
basically has not looked at other events in the past to 7.
historically be able to actually come up with a more unified 8
9 MR. HARDEMAN:
What do you mean are we concerned 10 about the schedule, concerned about the length of time that 11 it's going to take them to do all this work.
12 CHAIRMAN MOHSENI:
Yes.
Yesterday, Jean stated 13 that -- asked actually, "Do you guys want us to look into 14 other events", and Aubrey's response was, "We're not telling 15 you anything.
You decide what FDA needs to do to come up 16 with the basis".
17 MR. HARDEMAN:
But now we're --
18 MR. GODWIN:
We told them something else.
"You go 19 public, you're going to be nailed".
20 MS. PEPPER:
If you haven't done all the other 21
. studies, you've got the critics'--
22 MR. HARDEMAN:
We're not telling them what to do, 23 we're just providing them with the benefit of our advice, 24
'that you really ought to look at these, s
25 MR. GODWIN:
You need to recognize that the O
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+
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758 Windscale event was reviewed as part of the '82 study, 1
so 2
they did have some data on that somewhere around or had it.
3 CHAIRMAN MOHSENI:
Which led to the 25 rem.
4 MR. GODWIN:
Well, it started out 10 and then the 5
final version was 25.
6 A VOICE:
Have we seen that?
7 MR. GODWIN:
Yes, we've got a copy of it somewhere 8
around.
9 MR. HARDEMAN:
The Windscale?
10 MR. GODWIN:
Windscale, it's alluded to in the 11 original publication.
12 MR. HARDEMAN:
But we didn't get any results of 13 the study.
14 MR. GODWIN:
There's not much data.
15 CHAIRMAN MOHSENI:
NCRP 55, you know, that's what 16 can be relied upon to get the -- we did have indications 17 that there was a thyroid dose of, was it 18, 16 RAD, which 18 did not result -- of iodine 131, by the way, not different 19 in terms of the source term from Hanford.
In both cases, 20 you do not see evidence of thyroid disease.
21 MR. HARDEMAN:
Over what period of tim? was that 22 dose deliverad?
23 CHAIRMAN "OHSENI:
It would be -- Windscale?
24 MR. HARDEMAN:
Windscale.
25 CHAIRMAN MOHSENI:
Was it months?
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i l
759 l
1 MR. LANTZ:
It says, "In October of 1957", so --
()
2 CHAIRMAN MOHSENI:
Remember the bulk of the 3
exposure from' iodine 131 it was through the milk pathway and l
4 so norm -- it was pretty much -- if you go back to the 5
Hanford releases, you had several events of large releases 6
of iodine.131 this month and then another month, and you 7
know, overall.
8 MR. HARDEMAN:
Right.
9 CHAIRMAN MOHSENI:
And each one produced in the --
10 you know, and I think the bulk of the dose is delivered, if 11 it's through the ingestion pathway, within five months, so 12 within months the dose was delivered in Sellerfield and the 13 consequences as documented in NCRP 55 was that they didn't 14 find any evidence of thyroid cancer.
15 MR. SHERIDAN:
Right, so we have Hanford, and we 16 have Sellerfield, both did not basically find any evidence 17 of cancer, and then we have this Belarus study --
18 CHAIRMAN MOHSENI:
Yes.
19 MR. SHERIDAN:
-- that is based on, it seems to me 20 a lot of guessing because they didn't have any measurements, 21 they didn't any of the baseline stuff that you need.
I 22 think -- it seems to me that there's a problem here.
23 MR. McNUTT:
Well, to get back to the issue I 24 thought we were discussing, if we do nothing at this point 25 and let the FDA -- go along with their course of action,
()
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V:
760 1
which is primarily, perhaps even solely reviewing the 2
literature with no review of hard data, they will issue 3-their guidelines and their recommendations in draft and 4
they're going to get comments like those provided by Mike 5
and others here.
6 And they're going to be forced to, I think, to go 7
back and then look at this hard data, at this raw data.
And
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8 so that's going to be time-consuming.
So why don't we just 9
be a little bit pro-active here'and direct them to do a more l
10 comprehensive research.
11 MR. GODWIN:
It will also help if it turns out 12 after a good hard look at the data that this one rem number 13 is not right, you won't have already put on the street a 14 tentative position that is good and we have to fight that 15 off.
Now, if it is the right number, you'll have a much 16 better feeling when it goes on the street that you need to 17 be doing something.
So it looks to me like it's a win / win 18 situation as far as FDA is concerned if they do the hard 19 research that needs to go into that.
20 MR. McNUTT:
Yes, so --
i i
21 MR. HARDEMAN:
But I think when they go into it --
l 22 let's assume for a moment that the raw data are available or 23 at least no so massaged data and let's assume for a moment 24 that that data not only looks at radiciodine but looks at
-25 the whole spectrum of what was there, both -- and it will i
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761 1
probably have to be bared on a computer model or a
()
2 calculation of, you know, what was in the air, what was on 3
the ground, so on and so forth.
4 You know, we know all the assumptions about well 5
if we found cesium somewhere, then we're going to assume 6
that iodine was there as well and we had a uniform ratio of 7
iodine to cesium and all of those problems.
Well, what I 8
want to make sure is'that when FDA goes into this that they 9
don't go into it with the I-131 blinders on but that they 10 look at the whole set of data and really make an effort.
11 You know, they can make a postulate, " Iodine 131 caused 12 these cancers".
13 Then look at the raw data and say, "Do these data 14 support that conclusion given not just I-131 but the whole 15 spectrum of what was there.
And I don't know what those raw 16 data look like.
I don't know, you know, what kinds of 17 things are there.
I've got a pretty good idea as to the 18 quality or lack thereof of that data.
So I really don't 19 know the data are sufficient to just make that leap of faith 20 and come up with a conclusion that all of these observed 21 thyroid cancers are due to I-131.
22 MR. GODWIN:
I would like to see them approach it 23 from the opposite position.
24 MR. HARDEMAN:
That I-131 does not --
i 25 MR. GODWIN:
And then see --
i
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MR. HARDEMAN:
-- and see if that is supported.
()
2 MR. GODWIN:
Yeah, and see if that's supported or 3
disproved and let's see where it goes from there.
I think 4
it would be a more objective approach to it.
5 MR. HARDEMAN:
The only problem there is it's real 6
hard to prove a negative.
7 MR. SHERIDAN:
Well, to get back to what Bill was 8
saying about providing direction, do we have the wherewithal 9
to be able do to that.
10 MR. GODWIN:
We can ask them to do these things, I 11 think, without any problem.
We can just ask them to do it, 12 a request.
13 MR. HARDEMAN:
We can tell them that, you know, 14 based on the presentation that we heard yesterday, that 15 we're -- you know, in the interest of this thing being based
.6 on sound science, that we're a little concerned about the 17 quality of the data that FDA seems to be hanging their hat 18 on.
19 MS. KEY:
Did I misunderstand her yesterday?
It 20 seemed like that there was -- she kept saying that these 21 doses for iodine 131 and people kept asking, "Well, was 22 there also a gamma dosage".
She kept saying, "Well, the 23 literature just says iodine 131".
It wasn't like they even 24 asked or looked at it and yet there was a reasonable reason 25 to think there was a gamma dose.
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1 1
763 1.
MR. HARDEMAN:
And it seemed like -- and I'm
()
2 assuming that they have access to the same papers that we i
3 had back in September in Washington, you know, there was a 4
lot of reference made to that Nature article in March of 5
'98.
You know, I'd hate to base federal guidance on -- you 6
know, on just a regular periodical article that comes out 7
with virtually no peer review, if any.
It just doesn't seem 8
to me to be a prudent course of action.
9 MR. GODWIN:
Well, I'd hate to base on a single
)
10 publication first of all.
11 CHAIRMAN MOHSENI:
True, so what are we going to 12 do?
13 MR. GODWIN:
I suggest it's appropriate to ask them to look at all the pertinent data to the best as they 14 15 can, as Andy suggested, go back and get the best quality 16 data that.they can, 17 MS. KEY:
And to be more critical of that Hature
{
18 article.
19 20 MR. HAi.DEMAN:
Don't accept the data on face 1
21 value.
22 MR. NAWOJ:
Is the pathway from this group to the 23 FDA or through the Commission or is there un option?
24 CHAIRMAN MOHSENI:
First of all, Jean is a member 25 of this committee.
So, you know, as a member of this I()
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committee, she's been working very hard to stick to our
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schedule.
She has formed for the first time in many years a 3
group in FDA that supports her and she's working -- and she 4
asked yesterday for some feedback and insights and I think i
5 this group is now providing that.
And so what we will do is 6
when we go back, when the transcripts are ready, we'll say, 7
"You can look at the last. day about our discussion relative 8
to the FDA presentation", and whether or not we can assist 9
in making sure that the data that she uses is more reliable, 10 if you will, in terms of -- but you also recognize that the 11 actual data that we have so far identified that exists from 12 Chernobyl just is not adequate.
13 You know, it's just not there to give us the I
14 answers we're looking for.
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1 15 MR. McNUTT:
Well, Aby, there may not be any data l
l 16 that's going to get us the answers.
17 CHAIRMAN MOHSENI:
That's right, that's right.
18 And so I think what we can ask is to -- for the data that is l
19 available, make sure that you look at the basis for that, 20 how it was collected, who collected it and when you hang 21 your hat on it, you make sure that you basically have a 22 justifiable position.
And in those cases where it's not 23 obvious that there is a link, you can still -- FDA can still 15 make a determination but recognizing that the data is not 25 there from Chernobyl to do it and gives the states or others ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
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1 some more insights as to the value of the protective actions O
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2 that you are considering.
l 3
Ultimately, that's what we want to do in this 4
document, present to the states pros and cons of, yes, 5
having Fi or not having KI.
What is it that you gain from a 6
public health standpoint and from a broader perspective for 7
your citizens and what don't you gain if you did that and so 8
forth.
9 So I think that, what you're just suggesting, we can just 10 turn around and ask Jean to take a more critical look, 11 MR. SIMPSON:
I think this is not to say that FDA, 12 Jean, hasn't done an excellent job up till now.
13 CHAIRMAN MOHSENI:
Yes.
14 MR. SIMPSON:
I think perhaps we, the committee s -
15 may be part of the problem because if you're given the task m
16 that she was given in the time frame she was given it, she 17 really didn't have the option of going back to whatever data 18 was there.
19 CHAIRMAN MOHSENI:
Right.
She made tremendous --
20 MR. SIMPSON:
She could not have done that.
21 CHAIRMAN MOHSENI:
-- p rogress.
22 MR. SIMPSON:
She did an excellent job --
u 23 MR. McNUTT:
She plans to meet that October date.
i 24 MR. SIMPSON:
She did an excellent job with what 25 she had in the' time available.
i
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MR. NAWOJ:
That's what I was getting at; is there
()
2 additional resource that may need to be brought to bear.
3 MR. GODWIN:
I think part of this, though, would 4
have to be a recognition by the Commission that we would like to put a document out based on current existing data 5
6 because FDA is obviously going to have to take more time or 7
they have to say, "Okay, suspend this operation until such 8
time as they come out".
Now, there might be some other 9
position we can take in between but that looks like the sort 10 of thing that's coming down.
11 MS. KEY:
But there are ramifications now that we l
12 weren't aware of.
13 MR. GODWIN:
I don't mind writing it based upon 14 the current guidelines.
Just recognize that three years 15 from now it might be out the window.
{
16 DR. SEALE:
I have an idea that the data that l
17 we're looking for to verify the effect of iodine on t:
18 thyroid, you know, is not -
_ aon't chink it's available.
I 19 If it were available, it seems to me we would have had 4*
20 and, you know, the Russfans have been over here countless 21 times with their seminars and their lectures and, you know, 22 they talk of the difficulties of dose reconstruction and so 23 forth.
I 24 It just seems to me if they had something solid, i
25 you know, we would know about it.
So maybe we're -- you
(
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know, maybe it's, you know, not there.
I'm not saying that 2
the FDA can't look but, you know, I just -- I think it's a 3
caution we ought to acknowledge.
4 CHAIRMAN MOHSENI:
I think I heard we discussed 5
two things here.
One was for her to look more critically at
{
6 the existing data in Chernobyl, not to kind of look for things that are not there, but to look more critically at 7
8 the existing data from Chernobyl and two, to also look at 9
the other events that we have referenced already in the 10 document; you know, for example, the Windscale event may 11 need to be -- and she was asking and she got the -- you 12 know, we gave her the references for that particular -- that 13 may come into the decision making process --
14 MR. SIMPSON:
Marshall Islands, Utah.
15
HAIRMAN MOHfm I:
- Utah cohort, yes, those are 16 some of the things that u * - * :.a li. 2
eeds to go back 17 and of course, everybody arrund che 1.able felt that, "We 18 were thinking that you had already done it as an agency".
19 You know, obviously thin was likc 20 years ago and may not 20 have transferred to the new people who are revisiting the 21 7olicy.
Good, we'll do that, I'll do that.
22 I'll turn around and call her and see if she needs 23 a letter.
Otherwise, we just remind her as a member of our 24 team that she's done a terrific job to get us to where we 25 are.
There was a lot of progress in that arena and there's
[(
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still a lot of work left to do.
()
2 On the second issue that Aubrey raised, whether or 3
not we -- I need to go to the Commission with an option 4.
paper, if you will, there are two ways of looking at it.
If 5
we really wait for FDA to study all those things that we 6
heard yesterday may not have been studied, it may take a 7
little bit longer than the end of the year for us to have 8
something in our hands.
9 MR. HARDEMAN:
That's a fair assessment.
10 CHAIRMAN MOHSENI:
Fine, I mean, but if we really 11 need to go forward with this thing at the pace we are, then 12-we may have with minor changes to the existing '82 policy 13 which are, you know, the hints we've got.
We'll see what 14 FDA tells us about those hints, but published in draft form A
(s l 15 our document relying on the existing language with minor 16 additional recommendations here and there for neonates.
17 And then you know, and change this document again 18 years from now when FDA actually comec back, I can put 19 that -- is that --
20 MR. HARDEMAN:
You mean months from now.
21 MS. KEY:
No, it's probably years.
22 MR. GODWIN:
Maybe years.
23 CHAIRMAN MOHSENI:
That's the point, because if 24 they go.back and do Marshall Irlands and all, then it may l
25 take them a'little bit longer, but to keep the momentum i
i I
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1 alive, though, how do we do that?
We don't want to lose r\\
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2 momentum indeed, not to push but not to lose momentum.
3 MR. SIMPSON:
On the other hand, we've got good 4
guidance out.here now.
It's been out there for a long 5
while.
If -- why do we need -- I feel a little 6
uncomfortable in putting together what amounts to interim 7
guidance now that may, in fact, be needed -- need revision 8
in a relatively short period of time, I mean, given the 9
amount of time the guidance has been out there already.
10 CHAIRMAN MOHSENI:
Okay.
11 MR. SIMPSON:
Maybe we don't need to do anything 12 further until FDA does get done.
13 MR. GODWIN:
Well, see that will be a decision for 14 their management to make.
You know, the NRC management O(s,)
15 wanted to ask us to come up and to help them do this and we 16 just tell them, "You know, this is a point you need to 17 consider.
You know, you either go forward recognizing the 18 document may be only good for two or three years and it's 19 going to be out the window", or say, " Hey, we're going to 20 wait the two or three years and since you already had the 21 stuff out before," and then it's their decision.
22 MR. HARDEMAN:
That's a fair capture of my 23 recommendation, j
24 CHAIRMAN MOHSENI:
Does everybody agree with 25 Aubrey's characterization of what I need to do for the ANN RILEY & ASSOCIATES, LTD.
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Commission and the Commission's decision on that?
)
2 MR..SHERIDAN:
I don't disagree but I need to 3
clarify something in my own mind.
What does this mean for
~4 communities that want to deal wit.h this issue and have KI 5
made available?
6 CHAIRMAN MOHSENI:
Under the existing guidance, 7
there is no reason why people cannot get it and FDA on the B
side-Jean said that Fhe Would look into Carter Wallace 9
making KI available to individuals who want to order it for 10 themselves.
So that should go on without impact from this 11 aspect.
It's only the threshold for giving it to the 12-citizens and so forth that really is at issue here.
13 There's no question that KI -- the conclusion they 14 drew from back in '82 that KI is safe and effective under 15 these conditions, that's valid today even with -- if 16 anything the Polish experience, you rely on it basically it 17 says, "Okay, it's safe and effective".
18 MR. SHERIDAN:
And where would that lead the state 19 and you know, let's assume you wanted to do it in our area 20 and --
21 MR. WILDS:
Well, we would base the decision on 22 the existing guidance.
We're holding up right now because 23 we're waiting for some type of final decision.
I mean, 24 right now the indication is, you know, FDA is gL ng to 25 change their guidance, EPA is going to be changing, you l
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know, EPA 400.
NRC is coming out with that new reg guide,
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2 you know, FRPCC.
You know, there's a lot of indications, a
3 lot of things are going to be changing quickly.
4 Now, if everybody steps back and we know that 5
there's not going to be any changes for, you know, three 6
years, because FDA is going to go back and take a real hard 7
look, we would then say, okay, we would continue with our 8
process and then make our decision based upon the existing 9
dosage guide.
10 MR. SHERIDAN:
But you wouldn't stall the process 11 until this --
12 MR. WILDS:
I don't see us stalling the process.
13 We just want to be very careful not to get ahead of 14 everybody and make decisions without knowing, you know -- we 15 don't want to make a decision this month, knowing that two 16 months from now something new is going to be coming out.
17 Once the situation gets stabilized, then you know, we would 18 make a decision.
4 i
19 There's not -- you know, and that doesn't mean 20 that three years from now -- I mean, we have to realize that I
12 2 when new guidance comes out at anytime, I mean, you need to j
22 go back and look at your existing plan.
So I don't see the 23 need if FDA is going to take three years of slowing down I
24 this process.
We can still come up with guidance for, you l
l 25 know, the existing policy.
I mean, FDA could change their 1
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772 1-policy three years from nor and ae would come out with a new 2
guidance.
3 Something could happen four years from now and FDA 4
comes out with a whole new set of guidance.
I mean, you 5
know, we der't know that.
We would just be looking for the 6
situatic
.c tet stable so that we would have something to 7
base our lons on that we could feel relatively assured 8
that, you knoa, next month there's nothing in the works to 9
change that.
10 I mean, but if goes stable we know that there's not going to 11
-- you know, there isn't anything in the works.
12 CHAIRMAN MOHSENI:
Okay, got it.
Fine, I'll 13 follow that route.
I'll go to the Commission or at least to 14 my senior management and put on the table the two options we 15 have and have them give us further direction.
16 MR. GODWIN:
And we can really take what we've got 17 and put it into a draft form pretty quickly either way.
18 CHAIRMAN MOHSENI:
Yes.
19 MR. GODWIN:
We just don't want to spend money 20 if -- you know, them not understanding that potential.
21 CHAIRMAN MOHSENI:
Well, if we had to use the l
22 existing AD 2 policy, it -- in two months we would be -- two 23 or three months we should be ready with a draft.
24 MR. GODWIN:
Sure.
I I
'25
.MR. McNUTT:
FDA guidance is just one component of ANN RILEY & ASSOCIATES, LTD.
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t-773 l
1 this cecision that the states are go'ng to have to make, I
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mean, you know.
l 3
MR. SHERIDAN:
An important one.
4 MR. McNUTT:
Right, it is an important one.
5 MR. GODWIN:
Well, but if they came out with a l
6 similar complex scheme as WHO, there's a lot of changes on l
7 what advantages -- pros and cons in the decision making.
8 MR. HARDEMAN:
Do we know if WHO based their l
9 guidelines on the same data set as the FDA was using?
10 MR. GODWIN:
The best I can tell, they were.
They 11 refer to the same Nature article.
12 MR. HARDEMAN:
The Belarus data?
13 MR. GODWIN:
Yeah, the combined set of the 14 Chernobyl data.
15 MR. HARDEMAN:
So Belarus and Ukraine.
16 MR. GODWIN:
It's Belarus, Ukraine and part of 17 Russia and it's all a combined set of data, which is 18 referred to in this document also.
19 CHAIRMAN MOHSENI:
Okay, could you pass this 20 around?
We're going to now look at the new tasks have 21 identified.
We'll go through those and assign them to the 22 members as appropriate.
Bullet one, Windscale health 23 consequences and dosimetry will have to be expanded.
We do 24 have.a'section on Windscale.
It didn't go into the doses 25 that NCRP 55 has and-we'll just include those and the ANN RILEY & ASSOCIATES, LTD.
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reference in it, so to answer your question, the Windscale
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2 information.
i 3
Description of the TMI experience regarding the decision to obtain KI and the decision not to give KI to the 4
5 public which was something else Tony raised; we'll get 1
l 6
the -- on~Windscale health consequences, is there anyone 7
around, a member who would like to do it, who's got it?
l 8
Okay, I'll do it.
9 Description of the TMI experience regarding the 10 decision to obtain KI --
11 MR. SHERIDAN:
Could I add to maybe suggest maybe 12 an expansion of that.
What would be interesting is if KI 13 was available and if it was, where was it and how long was 14
-- how long did it take to get it.
-O L/
15 MR. McNUTT:
This is on the TMI item?
16 MR. SHERIDAN:
The TMI.
17 CHAIRMAN MOHSENI:
Okay.
Andy?
18 MR. SIMPSON:
I think I would be the most logical 19 one.
I'm closer to the data on that one.
20 CHAIRMAN MOHSENI:
Okay.
And there was also 21 another recommendation that when explaining the experiences 22 that we have had, try to be factual and avoid guessing for 23 justification purposes and that was Tony's recommendation as 24 well.
So'TMI, day one --
l 25 DR. SEALE:
Is that in relationship to the KI i
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process at TMI?
2-CHAIRMAN MOHSENI:
When we're trying to actually 3
reconstruct events, if we don't know why they did something, 4
let's be factual but then you can also say the authors 5
believe that this might have been the reason for, you know, 6
the called, but let's be factual first so that they realize 7
that we're second-guessing here the reader.
8 Add a section on PAG for the thyroid in the case 9
that FDA does not address it.
Well, obviously, this was the 10 big issue yesterday.
This is Aubrey's recommendation that 11 it should -- the FDA should do that but if they didn't do 12 it, then we should have a section on well, the existing 13 PAG's or what's in the 1980.
14 MR. GODWIN:
Yeah, just put that in there.
'N-15 MR. HARDEMAN:
That's what I was going to suggest 16 is that would be a pretty easy plug-in for the existing --
17-if the Commission chooses for us t'o go down the road of 18 putting together a document in short term using existing 19 guidance, than that should be a relatively simple plug-in to 20 take that 21 MR. GODWIN:
Yeah, just put it in essentially, the 22 Federal Register notice and maybe a little update.
That's 23 it.
24 MR. HARDEMAN:
Yeah, exactly.
You could even 25 include the Federal Register notice as an appendix to the ANN RILEY & ASSOCIATES, LTD.
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report and write one or two paragraphs.
2 CHAIRMAN MOHSENI:
Good, done.
3 MR. GODWIN:
I'll do that.
4 CHAIRMAN MOHSENI:
Do you want to do it?
No, it 5
'doesn't matter.
6 MR. GODWIN:
Yeah.
7 CHAIRMAN MOHSENI:
I don't want to impose.
Are 8
you sure, Aubrey?
Okay.
Well, I'm pretty sure this part is 9
historical and probably FDA -- if you're just going to use 10 the '82 Federal Register notice and --
11 MR. GODWIN:
Yes.
12 CRAIRMAN MOHSENI:
-- you know, there's no point 13 for it and let FDA work on the new one.
We'll report the 14 historical thing.
Terminology; okay --
)
15 MR. SIMPSON:
That's a word processing problem 16 there.
17 CHAIRMAN MOHSENI:
Yes, great, we'll follow that.
18.
MR. GODWIN:
What term are you using?
19 CHAIRMAN MOHSENI:
We're going to go to 20 residential business distribution for example, to be more 21 accurate.
That's your recommendation, if you recall.
22 MR. GODWIN:
Yeah, but it's in advance of --
23 CHAIRMAN MOHSENI Accident, yes.
We'll define 24 pre-distribution as it historically has been used, meaning 25 pre-accident distribution,-you know, under -- where the ANN RILEY & ASSOCIATES, LTD.
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1 public can actually pick it up at pharmacies and stuff.
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2 That's --
3 MR. SHERIDAN:
Then get rid of distribution.
4 CHAIRMAN MOHSENI:
That's fine, okay.
I'll work 5
on it and you guys look at it.
6 MR. GODWIN:
Availability.
7 MR. SHERIDAN:
Availability.
8 CHAIRMAN MOHSENI:
Availability.
9 MR. GODWIN:
Pre-accident availability.
10 CHAIRMAN MOHSENI:
Yes, pre-accident -- actually 11 it's availability pre or otherwise.
12 MR. SHERIDAN:
Right.
13 CHAIRMAN MOHSENI:
Good, very good.
Add a -- now, 14 does that mean that Joelle and Mike will have to kind of go
)
15 back to their wrie.e-up and also correct the terminology?
16 MR. GODWIN:
Not necessarily.
She might have to.
17 CHAIRMAN MOHSENI:
Not necessarily.
She might 1
18 have to.
Okay.
Or else define it -- let's define it up 19 front that any time you use pre-distribution this is an old 20 term, historical term, so we're not changing that but by 21 that what you really mean is house to house delivery and
, 22 availability but in the future for future plans availability 23 is really public availability is the way we want to describe 24 it.
Okay?
Good.
25 So there is some changes then might occur in your i
1 ANN RILEY & ASSOCIATES, LTD.
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e:tisting write-ups.
If it is, let me know.
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, d,N) 2 MR. SIMPSON:
Can I just pick up a point on that?
3 I think you're right in saying availability is the overall 4
term, but I think availability when you get down into 5
methods, includes various things to include placing it in 6
the hand of the individual.
7 CHAIRMAN MOHSENI:
Yes, yes, methods, yes, 8
precisely, different methods of making it --
9 MR. SIMPSON:
It doesn't exclude post-accident.
10 CHAIRMAN MOHSENI:
Yes.
11 MR. GODWIN:
Post-accident there may be a much 12 greater role for the government.
13 CHAIRMAN MOHSENI:
Yes, precisely.
14 MR. GODWIN:
Although I would like to think not.
O k-
'15 CHAIRMAN MOHSENI:
Or reception centers, you know, 16 if you go there.
Does somebody -- do you want, Aubrey, to 17 actually write a paragraph or maybe Bill, would you like to 18 kind of write a couple of paragraphs?
19 MR. McNUTT:
On what?
20 CHAIRMAN MOHSENI:
On what we just discussed, 21
.which is --
22 MR. McNUTT:
Terminology?
23 CHAIRMAN MOHSENI:
Actually, remember the area --
24 the consideration portion that Aubrey wrote and you somewhat 25 changed?
I think it should come as an intro there saying l 'O l (g -
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2 you know --
3 MR. GODWIN:
I want to rewrite that whole section.
4 I'm going to rewrite that whole section, picking up Bill's 5
stuff and cleaning up some of the opinion out of it.
6 CHAIRMAN MOHSENI:
Okay, fine.
-7 MR. HARDEMAN:
And I may want to still put some 1
8 over-arching comments in there too about the go, no go.
9 CHAIRMAN MOHSENI:
Okay, let me --
10 MR. SIMPSON:
Aby, I don't know whether I gave you 11 some comments earlier right at the beginning of the meeting l
12 some time this week.
'13 CHAIRMAN MOHSENI:
The two paragraphs.
14 MR. SIMPSON:
Well, not only that but I gave you a
\\
15 rework, so there may be some editorial things and some that 1L6 you may want to consider before --
17 CHAIRMAN MOHSENI:
That's okay.
If it's 18 editorial, I'm not worried because we will have a technical 19 editor take the document and take care of it.
And then I
20 after that, you'll get to review it, so that the meaning has 21 not changed.
22 MR. SIMPSON:
There are a couple of things that I 23 suggest in there that are substantive as well.
24 CHAIRMAN MOHSENI:
Good, good, good.
I got plenty 25-of those inputs from you all and I will go through them.
l I
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MR. SIMPSON:
If you can't read it, call me.
2 CHAIRMAN MOHSENI:
I need the big segments in 3
there and connected and consistent.
Okay.
On this one 4
then, Aubrey, Bill and Jim, let Aubrey be the lead then.
If I
5 you guys provide your comments to Aubrey, you know --
6 MR. GODWIN:
This is on what?
7 CHAIRMAN MOHSENI:
This is your section, the 8
considerations.
Remember, you talked about considerations 9
that you want to rewrite, 10 MR. GODWIN:
Right, yeah.
11 CHAIRMAN MOHSENI:
Just make sure Bill and Jim, 12 that or anybody else for that matter, because that's a l
13 very important section that really defines the state and 14 local communities' methodologies of making it available to (3
V 15 the public.
So make sure that you're all comfortable with 16 the language and provide your comments to Aubrey.
Aubrey 17 will lead.
18 MR. HARDEMAN:
Would you -- you know, if you 19 remember the Washington meeting, you know, that decision 20 tree that we had up on the flip chart for a couple of days 21 22 CHAIRMAN MOHSENI:
Yes.
23 MR. HARDEMAN:
-- you know, it might help the l
24 readers out and I know that we put that together just for --
j 25 just as a tool for us to use during our discussions, but you ANN RILEY & ASSOCIATES, LTD.
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know, some sort'of a chart along that line kind of a
()
2 decision tree --
3 CHAIRMAN MOHSENI:
Marcia's chart.
4 MR. HARDEMAN:
-- to put that -- yeah, to put that 5
actually in the document.
6 CHAIRMAN MOHSENI:
Yes, I understand.
I was 7
always thinking of that.
8 MR. HARDEMAN:
I think it should be there.
9 CHAIRMAN MOHSENI:
Marcia?
10 MS. CARPENTIER:
Yes.
11' CHAIRMAN MOHSENI:
Can I ask you to make a pretty 12 chart electronically?
The last time it was on the wall.
13 MS. CARPENTIER:
Right.
Do you still have that 14 because I don't have a copy of it?
,s k/
15 CHAIRMAN MOHSENI:
We -- I have the actual m
16 write-up, you know, of the way I described it.
I have the 17 description of it.
18 MR. HARDEMAN:
I think we have a --
19 MR. SIMPSON:
I think it was in the notes.
20 MR. HARDEMAN:
Yeah, I think there was a gross 21 copy that the secretarial staff in Washington have in Word 22 Perfect, if I recall.
23 CHAIRMAN MOHSENI:
Okay.
It was later on 24 distributed by --
l 25 MR. HARDEMAN:
I don't know if it was distributed l
()
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in hard copy at that meeting.
I don't think it was b) q_
2 distributed electronically.
I could go back and check.
{
3 CHAIRMAN MOHSENI:
Okay.
4 MR. HARDEMAN:
I could go back and check.
5 CHAIRMAN MOHSENI:
I looked at it Monday.
I 6
looked for it in all the notes I had from previous meetings 7
and I couldn't find it.myself but yeah, I thought we needed 8
to have that in the body of the report.
9 MR. HARDEMAN:
Here is it.
Yeah, there it is.
10 Yeah.
11 CHAIRMAN MOHSENI:
Let me see.
Can I look at it?
12 Ooh, that's great.
Whose copy is this?
13 MR. HARDEMAN:
That's Andrea's copy from an E-mail 14 that I sent to the members if the E-86 committee after I got 15 back.
So I guess that was available electronically because 16
~I certainly didn't make it up.
17 CHAIRMAN MOHSENI:
Okay.
18 MR. WILDS:
Again, my point, Aby, I don't have 19 that.
The more we talk, the more stuff I realize that I 20 never got.
For example, that I never saw.
21 CHAIRMAN MOHSENI:
You know, if you go back -- did 22 it go from me?
23 MR. McNUTT:
It's from Julie Crutchley (ph) of the 24 NRC, December 7th.
25-CHAIRMAN MOHSENI:
Okay, Julie sent it out and I ANN RILEY & ASSOCIATES, LTD.
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may'not have been on that list because she sent it out to (q-
,J 2
the others.
3 MR. WILDS:
And that was probably too early for me 4
to be on the list.
5 CHAIRMAN MOHSENI:
Yes, you were not on board 6
even.
7 MR. HARDEMAN:
But I'm sure I've got it on my 8
E-mail.
If I.sent it to you, I'm sure I've got it.
9 CHAIRMAN MOHSENI:
Okay, then Marcia should also 10 have it because Marcia was on it.
11 MS. CARPENTIER:
It's December though.
My system 12 has deleted it a long time ago.
I'll have to take a copy of 13 that befora I go.
14 MR. HARDEMAN:
Her E-mail falls off after a 15 certain period of time.
16 MS. CARPENTIER:
Yeah.
17 MR. HARDEMAN:
Our computer gurus decided that we 18 didn't need any E-mail older than 45 days old.
19 MS. PEPPER:
Oh, you're lucky, ours is 30.
20 MS. CARPENTIER:
Ours is 30.
21 MR. HARDEMAN:
I've gotten around that.
I 22 CHAIRMAN MOh3ENI:
And that goes into the 23 consideration portion I would think.
It's very nice, 24 Marcia.
Thank you.
25 Add a paragraph or a page describing how l
t (y
i Li ANN RILEY & ASSOCIATES, LTD.
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monitoring of evacuees can be used to determine iodine t
2 exposure, i.e. caution about noble gas retention in body.
3 That's the paper we got.
If, you know, again for the states 4
to determine how they want -- I have that paper.
Does 5
anybody volunteer to write it up?
Hand me that.
6 MR. WILDS:
I'll write it up.
7 CHAIRMAN MOHSENI:
You'll write it up?
8 MR. WILDS:
Yeah, but I'll need that paper.
I 9
CHAIRMAN MOHSENI:
You'll need the paper, okay.
l 10 MR. GODWIN:
Write it without the paper.
11 CHAIRMAN MOHSENI:
Can I mail it to you?
12 MR. WILDS:
Wh:stever works.
13 CHAIRMAN MOHSENI:
Okay, I've made a note to mail 14 it to you.
That's the only copy I have.
We're looking at 15 the paper published on monitoring noble gasses retained in 16 fat.
i 17 MS. CARPENTIER:
You've got a copy?
i 18' CHAIRMAN MOHSENI:
Yes.
j 19 MS. CARPENTIER:
Would you mail a copy?
20 CHAIRMAN MOHSENI:
To everyone, to everyone.
21 MR. HARDEMAN:
Can I ask a quick question since I 22 wasn't here when that paper was discussed?
Is the focus of 23 taat, you know, very narrowly looked at in thyroid 24 monitoring?
We've got a columnated monitoring pointed at 25 the neck or was it more -- was it more like going through
!~
l l
l
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the portable monitor?
(
2 CHAIRMAN MOHSENI:
Going through a portable 3
monitor.
People may set it up, just by having noble gas 4
exposure alone will do it.
5 MR. HARDEMAN:
Was there any discussion in there 6
about noble gasses and noble gas products adhering to 7
polyester clothing and things like that?
8 MR. LANTZ:
That's the standard what everybody 9
thinks that it's noble gas in the clothing, around hair and 10 it's a minor --
11 MR. HARDEM.*N:
It's more complex than that.
12 MR. LANTZ:
Well, no, it's just that that isn't 13 it.
I mean, I have had people shower -- I mean, this number 14 is very consistent.
This is after people have showered.
()
15 This is after people have gone to paper clothing and the dominant factor of what I would find after exposure is they 16 inhaled noble gasses is all this body fat and the guys got 17 18 it-in their guts and people --
19 MR. HARDEMAN:
Well, I would think that you 20 wouldn't have all that much polyester clothing running 21 around, just fron historical reasons if nothing else.
22 MR. LANTZ:
Well, you're absolutely right that 23 adherence especially in an environment like this, adherence 24 to clothing of radon (ph) and other gasses, particularly 25 gasses is a true thing, but in the case of an event where O<
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there is lots of noble gasses, you will have a significant
()
2 amount of activity in the body fat equal to after a couple 3
hours, only a tenth of a micro-curie per milli-RAD of 4
exposure.
5 CHAIRMAN MOHSENI:
Private sector role in KI 6
distribution Bill McNutt?
e 7
MR. McNUTT:
- Okay, 8
CHAIRMAN MOHSENI:
Thank you.
Role of non-prcfit 9
organizations such as Red Cross in dispensing KI.
Bi31?
10 MR. McNUTT:
Okay.
11 CHAIRMAN MOHSENI:
Emphasis on individual 12 responsibility for personal safety, Tony.
No, I'm just 13 asking.
That's a good one.
I think that's a broad 14 important aspect that ultimately while the state and locals k/
15 are responsible for certain decision making, the individual 16 is responsible for his --
17 MR. SHERIDAN:
I'll write a paragraph on it.
18 CHAIRMAN MOHSENI:
Would you like to?
Thank you, 19 Tony.
And I will add word from the Commission direction in 20 the general policy section as to what it is that this group 21 is tasked to do.
'22 MR. SHERIDAN:
Could I add one other and I don't 23 know whether it goes on this list or not, but perhaps when 24 you're talk'ng with Jean, we spoke of the size of the pill 25 and if that's.-- we're in fact going to get to the point OQ ANN RILEY & ASSOCIATES, LTD.
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where we're going to distribute pills, whether they're
.O l
s,/
2 5
picked up personally at the drug store or whether they're 3
distributed by the government, following an accident or 4
during an accident, it seems to me that a real shortcoming in the way of the size of the pill right now is really 5
6 making life much more unnecessarily difficult and so I don't know how you deal with that but two pills -- two 16 mg pills 7
8 versus one, 130 or whatever it is.
Is it 130 pill?
9 CHAIRMAN MOHSENI:
Yes.
10 MR. GODWIN:
Yes, correct.
11 MR. SHERIDAN:
Would make it a lot easier for 12 people to deal with and I think that needs to be looked at.
13 MR. HARDEMAN:
Would it be something to address in 14 this PAG section or does that deserve --
O 15 CHAIRMAN MOHSENI:
Let me see --
16 MS. KEY:
I don't know that that is something 3
17 state and locals can deal with.
I think like that's 18 something between FDA and the manufacturer.
19 MR. HARDEMAN:
It's just something that we have to 20 recognize.
21 CHAIRMAN MOHSENI:
Even -- let me ask Bill; Bill, 22 is it possible that FEMA may contact Carter Wallace or Ambex 23 or the other r, a,
or any other manufacturer and find out 24 what the feasibility is of manufacturing pills in different 25 sizes so that ---
()
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MR. McNUTT:
Well, by FEMA I guess you mean me.
2 CHAIRMAN MOHSENI:
Yes.
3 MR. HARDEMAN:
You're the only one here, Bill.
-4 MR. McNUTT:
I've talked to the people at Carter 5
Wallace years ago.
I'm sure I can get in touch with all of 6
these manufacturers.
1 7
CHAIRMAN MOHSENI:
Okay.
Without of course, any 8
bias towards any particular manufacturer.
9 MR. McNUTT:
As a matter of fact, as you were 10 talking I was going through my mind saving up questions that 11 I could ask them about --
l 12 CHAIRMAN MOHSENI:
Okay.
13 MR. McNUTT:
Because you know, it's all going to 14 be tied to their, you know, good business practices.
15 CHAIRMAN MOHSENI:
Yeah, so if you could then give 16 us a paragraph on what -- you know, what you've learned from 17 whether or not manufacturers, even if we stay with existing 18
'82 policy, are considering simplifying life or state and 19 locals to give them, you know, the size of the pills may 20 change.
21' MR. McNUTT:
Right.
22 CHAIRMAN MOHSENI:
Two 65 is better than, you 23 know, 130.
Yes.
24 MR. LANTZ:
Well, I've been here wondering how we 25 got to the size of the pills of 130 milligrams and whether ANN RILEY & ASSOCIATES, LTD.
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or not you could have effective blocking with even smaller
(
2 pills because I was concerned about this breaking of pills 3
for neonates and hoping -- well, would even a 60 milligram i
4 be a better size pill, where you take one for young and then 5
go to two-for adults maybe, and how effective was 32.
'6 And I didn't have that data at hand and then I 7-found a very -- what seemed to be a very important graph 8
from 1962 and 1967 on I-131 uptake in the thyroid with the 9
stable iodine and it shows, you know, very effective, you 10 know, blocking for smaller amounts by like a factor of 19 or 11 20.
12 CHAIRMAN MOHSENI:
Yes.
Are you looking at the j
13 old draft reg?
14 MR. LANTZ:
No, I'm looking at NCRP 55.
15 CHAIRMAN MOHSENI:
Which we also reference.
We 16 said where the 130 came from and indeed much less than 100 17 milligrams of actual iodine would block, except they went to 18 that amount because of the justifications given a few --
19 MR. LANTZ:
What is says there that in 1967 one 20 doctor said that it seemed reasonable to supply adult doses 21 to children.
So they kind of just moved and said, "Well, 22 you know, if 130 milligrams of KI doesn't hurt anybody, then 23 just give it to children".
24 So in light of newer studies, maybe a smaller 25 pill, even smaller than 65, might -- at least it should be ANN RILEY & ASSOCIATES, LTD.
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considered and t'.en go one or -- you know, two for adults or
()
2 more, just from a safety factor, since our target audience 3
target -- the population are younger.
4 MR. COWLEY:
Well, a 30 milligram pill scored in 5
half so that one-half of it is good for under four months 6
old and then a full pill or two pills for teens and adults.
7 CHAIRMAN MOHSENI:
Aubrey?
8 MR. CJDWIN:
Part of that went into the FDA's consideration in '82 when the came up with their '82 policy 9
10 statement.
That's where they discussed the size of the 11 pill.
And this was -- I'm trying to remember.
It seemed 12 like there was some discussion -- there was a pharmacist 13 involved that did that work and it seemed like it had to do 14 with some of the dietary areas that might be deficient to s
15 make sure they had enough to cover those,-too, but as I s
j 16 recall, that's not -- there wasn't much of an interest in 17 the Poland area where they gave 77 milligram doses and some 18 areas are also dietary deficient.
I 19 So it may not be important at all so I would hope 20 again FDA, who is sort of controlling the drug issue, would 21 look Lt the size of the pill both phyrically and the number 22 of milligrams.
23 MR. LANTZ:
For logistics and cost alone.
24 MR. GODWIN:
Yeah.
One thing you have to be most 25 concerned about is you add filler to the material.
Your ANN RILEY & ASSOCIATES, LTD.
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filler materials may lead to deterioration of the tablet 2
after a period of time; whercas, pure potassium iodide may 3
be much more stable.
So they just have to look at that 4'
issue, too.
I 5
CHAIRMAN MOHSENI:
So we've added the size of pill 6
discussion with FEMA talking with the manufacturers.
So 7
that's Bill.
8 MR. SIMPSON:
Now the other one of course that's 9
not on here is the big one that we talked about earlier, the 10 FDA and so on --
11 CHAIRMAN MOHSENI:
Yeah.
12 MR. SIMPSON:
-- but in relationship to this 13 conversation about pill size and so on, that brings me back 14 to our items perhaps for FDA.
I was not -- I did not -- I 15 wasn't sure, regarding the administration of the KI to the 16 neonates, that Jean was sure how it was done.
Was it all i
17 done in hospitals?
Was any of it done outside?
How as it 18 done?
Was it all done liquid?
How was it controlled, that 19 whole thing --
i 20 CHAIRMAN MOHSENI:
Is not ready yet in FDA, yes.
21 MR. SIMPSON:
But I mean, that whole aspect was 22 another aspect in the data that I didn't think was there.
23 Maybe she had it and I just didn't draw it out from her but 24.
I didn't know it was there.
25 CHAIRMAN MOHSENI:
No, I think she's still working l
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on many of those aspects.
One of them was what you just I
J 2
discussed.
So while she knew that there's going to be some 3
changes in that aspect, she wasn't sure exactly how.
4 MR. SIMPSON:
My point is going back to the base 5
data.
How did they do it, under what conditions did they do 6
it that would give us whatever that is, a better idea 7
whether parents, for example, should or should not be giving 8
a one month old --
l 9
CRAIRMAN MOHSENI:
She was waiting for information 10 for those 12 cases where, indeed, neonater had problems to 11 learn more what caused it and what was that and she did say 12 that the effect lasted -- was transient, lasting two weeks 13 and that -- less than two weeks and the thyroid function was 14 restored.
So she said all that and she's still working on l
! (
15 it.
She doesn't have the answer for us on that particular 16 issue yet.
Yeah.
17 MR. GODWIN:
One important point that she's 18 looking for and this is whether there was any neuro damage, 19 brain damage.
l 20 CHAIRMAN MOHSENI:
That's correct.
That's i
21 correct.
22 MR. GODWIN:
So.that's the key question that's 23 still hanging out.
24 MR. HARDEMAN:
And that's why we were asking a 25 question on follow-up on those individuals.
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MR. NAWOJ:
That's sort of a special case.
If
()
2 you're going to go there, I think you need to go directly to l
3 the hospitals and suggest that as a little take-home thing with the neonates that they have an appropriately prepared 4
5 dose of KI, probably in liquid form for the parents to use 6
and that way we're dealing with the hospitals that are of 7
concern, which is probably a smaller number and recommending 8
that course of action rather than trying to break up a 9
tablet which is a whole esoteric field of dosage that I 10 don't think we want to go to.
11 We're looking at relatively small numbers of 12 neonates in any given EPZ at any given time, I believe.
And 13 that way you get a mu;h better assurance of protecting that 14 particular special group.
15 MR. SIMPSON:
Which also then perhaps mitigates 16 against the need for having a 60 milligram pill at all if 17 it's' going to be done in the way you're saying it.
The 18 other side of that that we also didn't hear about yet is 19 what do you give to the pregnant woman and how much do you 20 give her who is carrying a child?
You know, that's a whole 21 other area, how do you do that?
22 MR. HARDEMAN:
Well, another problem with the 23 neonates, too, that utilizrtion of hospitals doesn't 24-necessarily correspond to geog;Aphy.
You may have somebody 25 inside a 10-milo EPZ that beccuse of the quality of health ANN RILEY & ASSOCIATES, LTD.
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1 care may use a maternity hospital 50 miles or more away.
So 2
it's a question of how -- to what -- if you go down that
)
3 road, it's the same argument that we had on, you know, how 4
many pills do you have to buy when we talk about this in 5
You know, how broad a net are you going to try 6
to cast.
7 MR. NAWOJ:
That guidance perhaps should be 8
provided to hospitals nationwide-.
9 MS. CARPENTIER:
So every hospital is going to ask 10 when you leave the hospital with a baby, do you have a 11 neonate that -- I mean, do you live five mileu from --
l 12 MR. NAWOJ:
Don't they know that?
Just take this 13 if you happen to be involved in a radiological emergency, i
14 give it to your child.
' V 15 MR. CARPENTIER:
That's going to be real 16 interesting public relation.
17 CHAIRMAN MOHSENI:
How does that translate into 18 action, folks?
19 MR. NAWOJ:
I don't know.
20 CHAIRMAN MOHSENI:
We know FDA is looking at it 21 and there's nothing else I can do.
We all know.
22.
MR. HARDEMAN:
We can go back -- I think we did 23 this in Washington, at least we discussed it.
We can ask 24 the FDA especially if they're going to go through this 25 process of looking -- taking a good hard look at all the i
)
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795 data, whether it would be warranted at this juncture to come 1
O (j
2 out with something talking about what does KI do to neonates 3
and if they do that, then perhaps, the opens the door for 1
4 looking at, you know -- that'gives us just another 5
distribution system that we can hang off of this decision 6
tree that we've got and look -- you know, look very 7
~specifically at, you know, in hospital or upon discharge 8
distribution to the parents of neonates.
9 MR. CASH:
I would like to say something.
I don't 10 talk much.
I want to get back to the very basic on this 11 thing.
We say that a severe accident or a design basis 12 accident, I guess design basis is very unlikely, a severe 13 accident as the utilities are now talking about severe 14 accident management guides, extremely unlikely to happen, 15 like won't happen, I think they believe.
16 Okay, I would like to get back to the purpose of 17 this document and suggest.these changes to that to get us l
18
'off to a -- and we can discuss that, off where I think we R19 should be.
The purpose of this document in the first part 20 of the abstract, "The purpose of this document is to provide 21 state and local decision makers with pertinent information 22 needed to determine whether the prophylactic use of KI.for 23 the general public is appropriate in the unlikely event that 24 a design basis or" -- we already say, "a severe accident, a 25 severe reactor accident occurs in this country", or however ANN RILEY & ASSOCIATES, LTD.
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1 you want to put that.
(~~
1 (,)
2 I think we put a whole lot of talk about whether 3
you're not going to use KI or whether we are going to use --
4 or make it available.
In Alabama, we're probably going to 5
continue to make it available.
We see that -- we don't think we're ever going to need it.
We don't believe we 1:.
6 7
ever use it, but if we do need it and somebody sometime is t
8 exposed to radioactive iodine and comes down with cancer, j
i 9
whether it be Jim or me or somebody else, that's a very 10 important element to that one particular individual, not the 11 whole population.
The whole population is not going to get 12 it.
I just think that we need to focus on that it's very 13 unlikely to happen; however, it is safe to use if it does 14' happen.
I O
(s /
15 MR. SHERIDAN:
Could I add to that, please?
16 CHAIRMAN MOHSENI:
Yeah, could you mark it up and 17 give it to me?
18 MR. CASH:
Sure.
19 CHAIRMAN MOHSENI:
Thank you.
20 MR. SHERIDAN:
I think we're going to include 21 other exposure, potential exposure.
Didn't we talk about 22 not just the nuclear reactors?
Didn't we also talk about 23 terrorists exposures?
24 MR. HARDEMAN:
I think we discussed it but the 25 Commission's charge is strictly to look at nuclear power ANN RILEY & ASSOCIATES, LTD.
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reactors.
(Oj 2
MR. WILDS:
There is a whole program for 3
terrorists activities and I suggest that that program 4
address what's needed, you know, for that.
5 MR. SHERIDAN:
Okay, fine.
'6 MR. CASH:
Does that make sense, Aby, or I can 7
rewrite it better?
8 CHAIRMAN MOHSENI:
No, this is. fine.
I wasn't 9
sure that I understood the difference because what you 10 described is basically what we wanted to do.
I wasn't 11 MR. CASH:
But I think that maybe starts it out 12 with saying what we've all talked about the whole time.
I Whether we're proposing to use or whether we plan to use KI 13 14 or not use KI.
We don't think it's ever going to be 15 necessary, obviously.
If Jim thought it was necessary, I 16 bet Georgia would be using it a long time ago, if he thought 17 it was likely an accident to occur.
18 MR. HARDEMAN:
Yeah, if I thought that it was 19 going to have a benefit to the overall protection of the 20 general public then, yeah there's no question that we would 21 have it.
22 MR. CASH:
Well, I'm an individual and I'm not as 23 concerned necessarily about the whole population as I am me 24 and you and you and my family if we happen to be in those 25 areas.
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I EN o
u ropose that design j
l 3
basis be added as well as severe accidents?
4 MR. CASH:
Well, severe accident is the way it's l
5 written now.
It's even more unlikely that a severe accident 6
by the new definition they're using will occur, what 10 to 7
the minus 9 or something like that.
I think a design basis 8
accident is 10 to the minus 6.
Release of iodine in 9
significant numbers 10 to the minus 7 or 8.
So you know, 10 you've got a factor of 1,000 difference between a design 11 basis accident and a severe accident, the way I understand l
12 it.
l 13 MR. GODWIN:
- Well,
- a. design base accident in some 14 of those scenarios, I believe could be design error.
15 MR. CASH:
It's a possibility, I guess.
16 MR. HARDEMAN:
You know, I mentioned this on Monday but there's a fairly simple tool, that being the 18 reactor technical manual, the '96 version, RT '96, that we 19 could follow through -- follow these event chains and, you 20 know, I realize that it's a broad brush approach and that
_21 each plant is a little bit different but I think you could 22-make some general characterizations as to which types of i
23 accidents at which plants are liable to produce large l
24 quantities of radiciodine and subsequently release that 25 radiciodine to the environment.
1
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I mean, I think that's feasible.
It certainly is g-2, as good a quality product as some of the data that we've 3'
seen from Chernobyl and, you know, I mean it might be -- you 4
know, it's a first order approximation.
Does that mean it's 5
no good?
6 CHAIRMAN MOHSENI:
Obviously, any state program 7.
can take the RTM and know the kind of plants they're working with to generate their own' site specific trigger levels and, 8
9 you know, it is -- we really want to help as much as 10 possible.
I'm not sure gross estimates are that helpful 11 initially because every one of them assumes, you know, all 12 this stuff is getting out and kind of makes things so black 13 and white that you almost always take --
14 MR. HARDEMAN:
But I'm not talking about using 15 this during a response.
I'm talking about using it from a 16 planning standpoint.
17 MR. WILDS:
I would suggest that instead of us 18 sitting down and making those decisions and intern-ations 19 of-that document for the states, that we hr vf l
20 reference material that we recommend they use in considering 21 the decision.
And that could be listed in there, so that 22~
they know this is where they need to go.
23 CHAIRMAN MOHSENI:
Okay, under -- so-called under 24 the EAL sections then, that's a good place --
25 MR. WILDS:
You know, I mean, instead of us trying 1'
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7-.
f 800 l-1 to --
(O 1
)
2 CHAIRMAN MOHSENI:
No, I understand.
So i
3 references of how to go about develop site specific 4
threshold plans for when and how and so forth, okay, I mean, 5
we reference them but it's a site specific development.
6 MR. WILDS:
Right.
7 CHAIRMAN MOHSENI:
Okay, you work with your 8
utilities and come up with --
9
'MR. WILDS:
I think that would be the best thing 10 for a state or a local community to make thac decision, that 11 they use their site specific situation in making their 12 decision and we not try to guess what those specific 13 considerations are but we tell them how to go about getting 14 answers.
15 CHAIRMAN MOH3ENI:
Good.
FDA will contact KI 16 manufacturers to make sure KI is available for individuals 17 to purchase and that we have Jean down and she has that.
18 She took'that down.
19 Puri iucation, in general policies, we will l
20 include a sectivu on public education in the general 21 policies section regarding the decision to go or not to go 22
'with KI.
In both cases we said public education is needed.
23 Need brochures from Tennessee and Alabama as a reference.
24 MR. CASH:
What brochures?
j 25 MR. GODWIN:
The calendar.
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MR. CASH:
Oh, okay.
Okay.
()
2 CHAIRMAN MOHSENI:
It says anything on KI on it?
3 MR. CASH:
Yes.
4 CHAIRMAN MOHSENI:
Okay.
5 MR. GODWIN:
You thought you were going to get 6
away with that, huh?
7 MR. CASH:
I'll give it to you.
1 8
CHAIRMAN MOHSENI:
Well --
9 MR. CASH:
I'll send it to you, too, Aby.
10 CHAIRMAN MOHSENI:
Well, it will go in as an 11 appendix to the report so everybody can see --
12 MR. WILDS:
Well, are you going to put the whole 13 calendar in or are you going to put extracts?
14 CHAIR 1DR MOHSENI:
Extracts.
15 MR. CARPENTIER:
It's a very small section.
16 MR. CASH:
Well, the information part of it, I'm j
17 sure is all you're interested in, yeah.
18 MR SIMPSON:
And any waiver forms you have.
19 CHA.'.DMLN MOHSENI:
Yes, that would be nice.
l 20 MR. CASH:
That is back over there.
21 MR. SIMPSON:
Oh, it's over there?
22 MR. CASH:
Yeah, Alabama's plan for --
23 CHAIRMAN MOHSENI:
Do you also send out other 24 brochures to the members of the public on -- informing them l
25 that KI is available?
(
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MR. CASH:
No (D
l V 2
MS. CARPENTIER:
No.
i l
3 MR. CASH:
Not the general public if that's what 4
you mean.
5 CHAIRMAN MOHSENI:
I'm done with the new tasks.
6 MS. KEY:
There was also just a lot of other 7
questions asked for the state, during our state talks and --
8 CHAIRMAN MOHSENI:
Yes, yeah, that's what I'm 9
saying, yeah.
10 MS. KEY:
And I had a concern in the differences in the way I presented the information and the way Alabama 11 12 presented that information.
I haven't really seen if 13-Arizona is different too.
I think we'll try and work 14 together to try and get it more consistent.
p
(_s).. 15 CHAIRMAN MOHSENI:
Without losing any of the 16 information.
17 MS. KEY:
Yes, yes, it's just the form.
18 CHAIRMAN MOHSENI:
It's very -- sometimes you gave f
19 information in an area and of course, Alabama didn't have 20 that kind of information because they didn't go through 21 that, but. don't lose it.
22 MS. KEY:
Right.
But that was just a very 23 different form and I would like us to have a more consistent 24 form.
25 CHAIRMAN MOHSENI:
Yes, formatting needs to be l
l f,
.).
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consistent but I want to go back again and saying everything
()
2 we asked you to produce more, it's going to be very useful.
3 Those are the states with experience.
To the extent we can 4
get info, we need to get it.
5 MS. KEY:
I can't guarantee.
I can get you some 6
of that but --
7 CHAIRMAN MOHSENI:
But there is also -- the big 8
document, you know, we haven't -- for example, there's a lot 9
of thyroid dosimetry that remains from the earlier draft and 10 nobody has changed any of that portion.
So that's going to J
11 stay.
There is the international component that Marcia can 12 look at.
13 MS. CARPENTIER:
Yes, I wanted to talk about what 14 we want to do with that and how much it is and if it looks
(
15 like a lot to maybe get a couple of other people involved.
16 CHAIRMAN MOHSENI:
Okay, the old draft had the 17 countries, if you recall there's -- and under Section 6, 18 international practice regarding the use of iodine, A is 19 World Health Organization guidelines.
Now, of course, that 20 changes.
The new draft is different.
We're going to ask 21 Aubrey probably to give us this revised section.
This, if 22 you note the table'2 has United Kingdom, Sweden, Germany, 23 Switzerland, Finland, France.
24 Because this was current as of 1998, March, you i
25 may just want to touch base and see if it's still current.
i I
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MS. CARPENTIER:
Okay, I can do that.
l 2
CHAIRMAN MOHSENI:
The IAEA guidance, again, l
3 whatever IAEA has adopted, you know, the individual contact, 4
Malcolm.
5.
i 6
MS. CARPENTIER:
Yeah, sure.
7 CHAIRMAN MOHSENI:
Malcolm Creek (ph).
And then 8
we have the comparison between U.S. and international 9
practice.
Would you again, Marcia, take a look and --
10 MS, CARPENTIER:
Yeah, okay.
As long as it isn't i
11 individual case studies on a country by country basis, then 12 I'd be happy to do that.
13 CHAIRMAN MOHSENI:
No, overall, yes.
Overall if 14 you could help us with that portion.
l
(~~
(
15 MS. CARPENTIER:
Uh-huh.
j 16 CHAIRMAN MOHSENI:
So I've got international from 17 Marcia.
18 MS. CARPENTIER:
With the exception that Aubrey is 19 doing World Health Organization.
I 20 CHAIRMAN MOHSENI:
Yes, as soon as he steps back 21 in.
International, Marcia.
22 MS. CARPENTIER:
Uh-huh.
23 A VOICE:
Are we going to take a break here in a 24 minute or are you going to go all the way through it?
25 CHAIRMAN MOHSENI:
Let's see.
I think we're i
I()
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almost done.
Let's go all the way through and let you guys
()
2 go home sooner.
WHO guidance, Aubrey.
3 The last thing I want to do is just go around the 4
table and see -- hear from each one of you about where we t
5 are and where we're heading.
Is there anything that we 6
missed?
Just short, sweet and, you know, kind of go around 7
and find out where we stand.
We want to get out of here by 8
maybe 11:00 if we do that.
9 MR. HARDEMAN:
Let's take a five-minute break.
10 CHAIRMAN MOHSENI:
Five is okay, but I'm afraid if 11 you guys go, you won't come back.
12 MR. HARDEMAN:
It won't take me longer than five 13 minutes, I promise you.
14 CHAIRMAN MOHSENI:
Okay.
Okay, a five-minute 15
- break, 16 (Recess.]
17 CHAIRMAN MOHSENI:
Let's go on the record.
- Okay, 18 let's go around and hear from each of you where we stand and 19 how -- what are the issues that -- are you satisfied with 20 the progress we have done so far and any major burning issue 21 we need hear about.
Let's start with you, Jim.
22 MR. HARDEMAN:
Okay, where we stand, as I said a
.23 little bit earlier, I think we're a fork in the road.
And I 24 don't think that our -- I don't think the Commission has 25 delegated the authority to us to determine which of these I
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forks we're supposed to take.
So I think we've got to go
('~\\
(,/
2 back to the Commission and get some additional direction and 3
guidance from them as to which one of these two paths they 4'
want us to follow.
5 I agree with Mike's statement down here about, you 6
know, it's absolutely ludicrous that we can pooh, poch the 7
Hanford data and on the other hand, it seems like FDA has 8
for the most part, I won't say blindly assumed but at least 9
assumed on faith that the Chernobyl data are reliable.
So 10
-- and if they continue down that course and come out with 11 some guidance based on what they have right now, the 12 documents they've looked at, I think it's going to be a very 13 bloody public comment period.
14 CHAIRMAN MOHSENI:
Thank you.
Andrea?
- (3
\\s /
15 MS. PEPPER:
I would agree with that.
I'm 16 delighted to have been able to attend this meeting.
I 17 missed the last one, I was on vacation.
I'm looking forward 18 to the next one.
Yeah, I'm real happy that we've gotten 19 this far.
We need to also find out from the Commission what 20 the time frame is; how urgent is it to get it done now and 21 or as opposed to, you know, waiting for the FDA.
22 CHAIRMAN MOHSENI:
Okay, thank you, Marcia?
23 MS. CARPENTIER:
I agree with everything that's 24 been said so far.
It's pretty clear and my concern beyond L
25 this. document is, of course, the revision of EPA 400 and so ANN RILEY & ASSOCIATES, LTD.
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I ask you to please keep me in the loop about these
)-()
decisions as they get made and I'll make sure that they get 2
3 passed along to the people working on that project.
4 CHAIRMAN MOHSENI:
Have the begun?
5 MS. CARPENTIER:
They have just begun but I don't 6
know what their time line is yet, and obviously what the FDA 7
is doing has some impact there.
8 CHAIRMAN MOHSENI:
What exactly are you guys 9
revising?
10 MR. CARPENTIER:
The entire document.
You know 11 how it's got two different chapters each on early, 12 intermediate and late phase protective actions and so.
13 That's going to be combined so all the early stuff is 14 together for example, and more nuclides will be added to 15 account for other types of accidents beyond reactor 16 accidents and so on.
So they're revising it for a number of 17 reasons, most of which don't have to do with KI, but given i
18 how often these things happen, it would be nice of the time 19 lines mesh somehow.
20 CHAIRMAN MOHSENI:
Thank you.
Andy?
21-MR. SIMPSON:
Speaking on behalf of NEMA, of 4
22 course, the states very much need to have the option of 23 making the decisions and I think we've discussed that here.
24 Clearly there's no question that that's the direction.
1 25 There's no contrary guidance to that.
I don't know whether
()
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this portion is NEMA or not because obviously, I haven't had
()
2 a chance to talk about it but from my perspective and 3
perhaps NEMA's perspective, because of the uncertainties 4
that are there, it might be premature on the part of those 5
states that have not yet started a review process, to take a 6
look at whether -- and consider whether they want to wait 7
until these uncertainties are clarified.
8 Those that are in the process of making decisions, may make the decision to continue on to completion.
- Now, 10 speaking for Pennsylvania, our work group, which I also 11 happen to be affiliated with there, has mad's the decision 12 and you saw the little blurb I put in the paper there, 13 they've made the decision that they will continue on with 14 their tri-partite studies but will stop until this group; 15 FDA, FRPCC, all of that is completed.
16 Now, perhaps if it turns out, you know, that it's 17 going to be an elongated period of time, they may do 18 something in the interim, I can't speak for the group in i
19 that regard.
But I-think I was pleased to see the progress i
20 that we've made but as with all progress, as you turn over 21 one rock, you often find two or three more rocks that now 22 need to be turned over.
l 23 CHAIRMAN MOHSENI:
Thank you.
Ed?
24 MR. WILDS:
You know, I like the progress that i
25' we're making here.
I mean,'it's sort of on track.
And in ANN RILEY & ASSOCIATES, LTD.
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Connecticut, like I said, we're not going to, you know, make nk,)
2 decisions and go past, you know, whatever is being done 3
here.
We will not make any final decisions till this 4
document comes out and things can be finalized.
And that, 5
I've got to go back and ask, do you want -- I mean, we are 6
not making'any policy decisions right now.
7 We are just -- how did you want to do that case 8
study?
I mean, with us it seems like we're not really a 9
good case study on what to do because we haven't made any 10 decisions.
You know, we're purposely holding back so that 11 we don't have to go back and revisit our position.
I mean, 12 that's --
13 CHAIRMAN MOHSENI:
That in itself is a good, I 14 think, reflection of where one of the states stands, 15 vis-a-vis, the information available to you.
And I thought 16 I heard the same thing for CRCPD, that indeed the 17 information up there, we're at this juncture and --
18 MR. WILDS:
Right.
19 CHAIRMAN MOHSENI:
We don't know where -- and what 20 is the time frame?
Is there a rush?
Is there -- can we 21 wait?
Patience, is that -- so I think the case study is 22 still on track.
If we just arrive at what you just 23 described, saying that bits and pieces of information as you 24
.have pointed out, but you describe your EPZ, you describe l
25 the relative magnitude of the implementation issues
()
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associated with such a populated EPZ as opposed to a smaller
()
2 less populated EPZ.
And I think that gives the states the 3
flavor that we have looked at cases where issues are a 4
little bit tougher to resolve.
I 5
And I think, therefore, I would appreciate if we 6
could continue to include the Connecticut case study there 7
for that reason.
That doesn't mean you have to make a 8
decision before -- we'll just reflect where you guys stand
~
9 as of then.
10 MR. WILDS:
Okay.
11 CHAIRMAN MOHSENI:
Mike?
i 12 MR. NAWOJ:
As I said when I first got here or 13 early on, I think that the fact thac a particular state or 14 emergency planning zone doesn't distribute KI to the public, 15 doesn't mean that they haven't considered it.
And it's 16-being considered again as we speak.
I think that's 17 important that there is information that's coming forward 18.
that may change the complexion of this.
19 I think a lot of progress was made as far as I can 20 see with respect to the availability of KI.
I think that 21 was key to us and it's key to the emergency planning zones 22-where there are large populations.
I think it was kind of 23 uncovered here that if it's a relatively low population EPZ, 24 the compulsion to distribute KI to the public is there and 25 it's a worthwhile program and certainly that shouldn't
()
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change.
()
2 If you're dealing with an emergency picnning zone 3
that has a larger populatica there are a lot more 4
difficulties.
Things get more complex and you need t lock 5
at other pathways.
Again, I don't think it was the 6
intention of any policy to deny the public the availability 7
of KI and I think if anything happened at this meeting here, I
8 that pathway was cleared and it appears to me that we'll be 9
able to bring the public into this partnership, if you will, 10 and enable them to protect themselves if they feel that's 11 appropriate.
12 The World Health Organization guidelines and the 13 proposed Food and Drug Administration dosage guidelines are 14 of concern.
I think they need to be looked at very close.ly.
15 I think we've uncovered a lot of bases for looking at them, 16 the Hanford study, what was I think very powerful.
A lot of 17 the Chernobyl data raises a lot of questions.
I think that 18 needs to be looked at in light of all the other data as 19 well.
And I think that's extremely important in coming out 20 with the intervention levels, looking at what exists and i
21 where they need to go if anywhere.
22 So I really appreciate the opportunity of being 23 here.
We'll take that back not only to New Hampshire but to 24 the Commonwealth of Massachusetts and Vermont, who we work 25 very closely with for the Yankee Emergency Planning Zone as
()
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1 well as Seabrook (ph) Station.
So we thank you.
O, j 2
CHAIRMAN MOHSENI:
Thank you, Mike.
Bill.
3 MR. McNUTT:
Yes.
You know, given the poor 4
dosimetry and the lack of hard data from Chernobyl, and the 5.
inconclusiveness of the initial FDA recommendations, I do 6
believe that there certainly isn't a smoking gun but I think 7
that I can look at that in totality and perhaps a reasonable 8
and prudent man or woman could -- you know, would find that 9
radiciodine contributed to the -- you know, the cancer in 10 the thyroid in Belarus and Ukraine.
And so I hope we can go l
11 further into the analysis but the Hanford study specifically 12 addressing the 131, a unique situation, no apparent 13 contributions to any additional thyroid cancers, yet the 14 doctors, you know, state that sure, radiciodine cause t'h k y) 15 thyroid cancer.
So I'm not so sure, you know, just how --
m 16 you know, how profound that study is for -- you know, for i
17 our use.
18 Other than that, you know, I think that FEMA is a 19 world preparedness organization as well as in response.
We 20-want -- you know, whatever this group decides and of course, 21 I'll be a part of the decision, I would just stress that the 22 public needs to be prepared for a radiological emergency and 23 whatever we can do here to enhance that is -- you know, is 24 my goal and FEMA's goal.
25 CHAIRMAN MOHSENI:
Thank you.
Joelle?
l l
/~'N
' +y,
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MS KEY:
I think that we're on a really good
()
2 track, that there's a good opportunity to have a really good y
3 article, but personally for the State of Tennessed, it's been very interesting and we've been doing this the longest.
4 5
We have this program where we've done some level of getting 6
it to the public before there's even an incident.
And yet, 7
a lot of the discussions, I think, can really influence what 3
we've done to make our program better.
So for me it's been 9
a great benefit just to bring all this information back to 10 Tennessee.
11 CRAIRMAN MOHSENI:
Thank you.
12 MR. CASH:
It's been very enlightening for me to 13 be at the December meeting and this meeting.
I've learned a 14 lot about why we have done what we've done.
As I said it's
()
15 been very enlightening, I think.
One of the things I want 16 to try to do is we're having an exercise before long which 17 will be FEMA evaluated.
I would like to try so come up with 18 a plan to try to really see say with 100 people or so 19 running through a reception center, what it would be like to 20
-- for them knowing nothing other than, " Hey, you've come 21 from this zone or this zone.
There's been a nuclear 22 accident", and let our people see how long it woul cake to 23 get some stuff done.
24 MR. HARDEMAN:
Is that going to be at Browns 25 Ferry?
O*
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'l MR. CASH:
Well, it's going to be at Browns Ferry (O
,j 2
if we do it.
It's an evaluated exercise.
I do not want 3
that particular part to be evaluated except by us.
4 MR. HARDEMAN:
Extent of play.
5 MR. CASH:
Yeah, but it might very interesting to 6
see what the results would be of that and if we could get 7
that done in time, I'd like to -- and we have some valuable 8
.information one way or the other, I'd like to be able to 9
present
- hat to you.
10 MR. HARDEMAN:
When?
11 MR. CASH:
That would be at the end of May.
12 MR. HARDEMAN:
I'm just speaking personally now, 13 but if you do wind up doing that, doing an exercise, I would 14 love to come over there and observe that.
15 MS. KEY:
Tennessee would also like to have a 16 representative, yes.
17 MR. CASH:
We will consider inviting you, Jim, 18 yes.
19 MR. HARDEMAN:
Well, whether you invite me or not, 20 I'd want to come.
I might just crash the party since it's 21 Alabama.
I'll follow the line.
22 MR. CASH:
We may let you be a crowd member, 23 that's right.
That would work.
I 24 MR. HARDEMAN:
It would be like making me mock 25 media.
I think I can come up with more questions than they ANN RILEY & ASSOCIATES, LTD.
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could answer.
r 2
MR. CASH:
We just want you to be there.
3 CHAIRMAN MOHSENI:
Is that it?
i 4
MR. CASH:
Yes.
5 CHAIRMAN MOHSENI:
Aubrey?
6 MR. GODWIN:
I suggest that we go back to FAC 7
management to see which fork they want to take.
I think 8
personally we should be working and planning on putting out 9
a document using the current FDA guidance based upon what 10 I've heard so far.
I think it would be of value to the 11 states now.
Several states are in the process of rethinking 12 their positions.
Even though it may change two years down 13 the line, I think the final position of FDA is going to be 14 at least two years down the line because even if they put 15 out the policy in September, and follow pretty much the i
16 position they're looking at right now, they'll get so many 17 public comments, they're going to take awhile to resolve 18 those and let their epidemiologist look at it, make 19 everybody take a look at it.
So I would think it's going to 20-be at least two years before they get there.
21 And so for that reason I would suggest that we 22 should -- you know, I think it's valid that we ask the NRC i
23 management about it.
I think it's equally valid that we i
24 plan to continue and follow it with the schedule of getting 25 this document produced by the end of the year or this fall.
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I think we ought to make that our goal to keep working
(
)
2 toward that and adjust all of our comments to look at the 3
present U.S. guidance situation.
And if they should by 4
chance come out, you know, we might have to get on a fast i
5 track to get it out quicker, we'll just have to adjust it 6
then, but I think that would give us a working position to 7
go with and that's what I suggest the committee would work 8
toward.
9 CHAIRMAN MOHSENI:
Thank you.
Tony?
10 MR. SHERIDAN:
Well, first of all, I thoroughly 11 enjoyed working with all of you so far.
If someone had told 12 me eight years ago when I ran for office that I would be 13 sitting in Arizona talking about potassium iodide, I don't 14 think I even knew what the damn thing was then, instead of 15 trying to rur. around fixing potholes and plowing snow, I 16 would have told them they're out of their mind.
But it's 17 been a very valuable experience.
18 And I guess what I appreciate more than anything 19 else is the level of seriousness that everyone here has 20 taken on this issue.
And obviously everybody here is quite 21
_ concerned about doing what's right.
And like most of the 22 public meetings I attend, if the public could somehow be 23 aware of how serious their employees, which is what we all l
24
'are basically, took their interest to heart, I think they'd 25 have a very attitude about government.
But unfortunately, i
I
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you know, most of the public is busy doing their thing.
2 But anyway I really have appreciated the 3
opportunity not just to learn from all of you, most of you l
l 4
know more about this subject than I do, but a couple of 5
concerns that I have.
We are public employees.
The public 6
has really asked for some answers here and I get concerned 7
when I hear the possibility that FDA might not be able to do 8
what we're asking them to do in a timely fashion.
9' This is the Federal Government we're talking 10 about.
They have people coming out of their ears.
They 11 need to get on this and I think that would be the message I 12 would -- the NRC put all of us in a position of having to 13 deal with this. We need to deal with it and to -- now that 14 it's out on the table, I think it would be highly 15 inappropriate for any governme.nt agency to drag its feet.
16 If Jean needs more staff to do what she has to do, 17 she should get more staff.
I know that's easier said than 18 done but it's really -- I think this is an issue, it's hard
.9 to explain to people back home when they say, "Well, how 20 come, you know, there isn't a policy on this matter".
- Very, 21 very difficult to explain and they don't want to hear that.
22 So I hope we can keep our time on it.
I guess that's the 23 long round about way of saying what I really want to say.
24 The other concern I'd have is the ones that have l
25 been mentioned by just about everybody; the accuracy of the ANN RILEY & ASSOCIATES, LTD.
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information, the size of the pills, and timeliness and so
()
2 on, but I do appreciate and look forward to having you all 3
maybe in Waterford for our next meeting.
4 CHAIRMAN MOHSENI:
Thank you. Dick, any comments?
5 MR. COWLEY:
Oh, yeah.
I really appreciate
)
6 getting a chance to hear the discussions and I know a lot of 7
the opinions expressed are very deeply felt in a lot of 8
areas and I share some and maybe not share quite so deeply 9
some of.the others.
And I know I can in here with my own 10 preconceptions of what was going -- what my theories of KI, but I think I've been -- the discussions have opened my eyes 11 12 a lot to an awful lot of more aspects of the decisions to 13 the point where I don't know that I can hold much more, but 14 it's going to take me awhile to straighten some of this out
(
15 and t hen to put it down and then I think. I'm going to take it back and have our agency have at least a long good full 16 i
17 day's discussion on this, not a usual staff meeting but a 18 more focused staff meeting and maybe even two days for a 19 retreat or something so that we can really hash our own
{
20 opinions out on this and see what we want to do.
21 But we're in a situation more like Arizona where 22 we have a smaller population.
In fact, only like 45 percent j
23 of our whole ten-mile EPZ is public.
The rest of it is 24 federal and so we really -- and 95 percent of that is l
25 sagebrush.
So I really appreciate what's going on here and i
l Os ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 i
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819 looking forward to seeing the transcription on the internet, 1
2 spending the week downloading it that it's going to take I'm 3
sure, but I really appreciate it.
4 CHAIRMAN MOHSENI:
Okay, thank you very much for 5
joining us.
I know that you came down from the State of 6
Washington and Mike came down from New Hampshire.
You certainly added a lot to the discussions and we encourage 7
8 that you continue keeping your interest up high and provide 9
your comments to us.
And I also want to thank the audience.
10 We've had great participation from technical folks that 11 participated in the -- at times in providing some comments 12 to us and --
13 A VOICE:
Let's see if they have any more comments 14 they'd like to make.
O, 15 MR. HARDEMAN:
Yeah, we didn't really have a 16 public comment period this morning, I don't think.
So --
17 CHAIRMAN MOHSENI:
Okay, perfect.
18 MR. MADDOX:
Yeah, I'm Merrill Maddox from the 19 Southern Nuclear Operating Company in Birmingham and first 20 of all, I'd like to thank the group for the work that you 21 guys have done to date.
It's encouraging.
I've relayed 22 that to Aby.
I think it's a good job that you are doing.
23 I'd like to make a few comments with regard to the 24 draft document, the 1633 document.
First, I'd like to 25 applaud the policy that the administration of KI will not ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034 1
820 1
impede or become an impediment to evacuation.
I think 2
that's key and the core group has kept that well within 3
focus.
I've got a few specific comments on the document 4
itself.
5 Page III, Roman numeral three and Roman numeral 6
four, just from a historical perspective, I would consider 7
for the group to -- and Mike Cash alluded to this a little 8
earlier, but I would consider in that background information 9
that the state and local people, leaders, will use this 10 information to make decisions regarding KI.
I would 11 consider adding actual probability numbers from your -- from 12 known reactor safety studies, studies that have been 13 published that result in releases of radiciodine to the 14 environment that would suggest at that level KI would be 15 administered.
16 In other words, let the decision makers know just 17 exactly how infrequent these postulated accidents may occur 18 in actual numerical terms.
And I don't remember the numbers 19 but they are well over 10 to the negative six in 20 probability, if iodine is out in the quantity where you 21 would intervene with the administration of KI.
And in that 22 same light, remember that there are some several thousand 23 reactor years of safe reactor operation already on record.
24 I had another comment regarding the Windscale 25 accident but I think you guys addressed it well earlier, is ANN RILEY & ASSOCIATES, LTD.
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rc 821 1
that there was a significant release of radiciodine to the
()
2 environment and iodine did get into the food supply and 3
there were people exposed.
And I think that the group would 4
be remiss if that information was not gathered in and you 1
i 5
know, included in the document.
And as well, the Army'c 6
S0-1 low power reactor in 1961, the accident there, there 7
was a significant release of radiciodines into the 8
environment.and that may be something that -- where 9
information could be gathered.
10 I'm not sure about exposure but there were a lot 11 of things there that were different that mig.t be worth 12 studying.
It was in the middle of winter and it was 13
. snowfall and, you know, different weather conditions, 14 meteorology.
15 Finally, I'd like to just conclude my comments by 16 statements regarding the FDA's recommendations of 17 administration of KI down to doses as low as one rem and 18 just offer it up to remember that if that is, in fact, does 19 go into policy then that is going to come in serious 20 conflict witr he policy that the group has taken with 21 regard to KI impeding evacuation because that, in my way of 22 thinking, that's making KI come first and then evacuation 23 later.
Thank you.
24 CHAIRMAN MOHSENI:
Thank you.
25 MR. LANTZ:
I think I'd just like to simply second ANN (ILEY & ASSOCIATES, LTD.
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1 Tony's comments that I was amazed all week to listen to a
, ()
2 group of intelligent people going over many issues and 3
working them out.
I assume you're going to continue on with l
4 this good work and I wish you luck.
5 CHAIRMAN MOHSENI:
Thank you.
6 Schedule, we want to -- out target goal other than 7-the fact that I've got to go to the Commission for the l
8 juncture decision making path, should we continue along the 9
path that we have, which there's no reason why we shouldn't, 10 even with the existing guidance of FDA.
We want to publish 11 the draft, not publish, we want to get the draft approved by 12 this committee by late June.
So that's really probably the 13 week of the 21st of June.
14 That committee's approval that week, well, you 15 know, shortly thereafter.
That's not done in a meeting 16 format.
We don't convene again until we receive public 17 comments on the draft new reg.
So what you will do will 18 review -- I will send you as we develop the document further 19 for your review and when it's approved by members of the KI 20 Core Group, we then will submit it to the NRC Commission, 21 saying, "This is what ths KI Core Group came up with", and i
22 ask them permission to issue it for public comment.
i 4
23 If they have comments, we'll take those comments 24 and run it by you one more time.
If they do not, if they i
25 approve, then we will issue it for a period of normally I
l (n)
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three months is reasonable.
You know, is there any reason
)
2 why we should deviate from three months for public comments?
3 MR. HARDEMAN:
No, I don't think so.
4 CHAIRMAN MOHSENI:
Okay.
So when -- if I present 5
the document to the Commission by end of June, I think the 6
Commission may take two or three weeks to turn around and 7
give us the direction for either changes to be made or 8
publish it for comment.
And I'm therefore, thinking 9
_beginning of August it's issued for public comment for a 10 period of three months, August, September, October, and we 11 can probably meet some time in November then and review 12 public comments.
That changes what we discussed yesterday 13 in terms of scheduling.
14 And if we then review the comments and make the s-)
15 necessary changes, it may be ready for final publication by 16 end of December and that coincides with the timing for the 17 FRPCC to know by then where they stand and the rulemaking 18 package and so forth.
Is that reasonable?
Does that give i
i 19 us --
20 MR. CASH:
Sounds good to me.
]
21 CHAIRMAN MOHSENI:
Aubrey, what do you think?
22 MR. SIMPSON:
I think it's quite ambitious but not 23 impossible.
24 CHAIRMAN MOHSENI:
Well, the way we worked this 25 week, I think we have demonstrated that it's not even b
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824 1
ambitious for this group.
It may be ambitious for other
()
2 groups, but this group rolls on.
3 MS. PEPPER:
With the excellent leaderr
~.p or our 4
chair.
5 CHAIRMAN MOHSENI:
Thank you.
6 MS. PEPPER:
I spoke loud enough to be heard.
7 THE REPORTER:
I got it.
8 MS. PEPPER:
It's on the record, 9
A VOICE:
Do you want her to repeat that, Aby?
10 MR. HARDEMAN:
Are you certain that we're not 11 going to need one more meeting to wrap up the draft or do 12 you think we can do that by E-mail and fax and --
13 CHAIRMAN MOHSENI:
If it doesn't work, if the 14 committee members absolutely think we need to debate this
(,s/
15 one'more time, obviously, we'll change our present planning.
i 16 My fee?ing is that we almost have tb3 -- look, the i
17 transcripts are in front of you.
You know that it's a 18 diffic11t ',ask and we're writing pros and cons.
We're not 19 advocating anything, so that makes our job very easy in 20 terms -- we don't have to evaluate what policy is better.
21 We're just going to put down a list of pros and 22 cons for each of the methodologies and the pros and cons for 23 having or not having a KI program all this relative, at 24 least today with the FDA guidance.
And sc that should 25 relatively be doable.
Should there be a new event, new (s)
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information that comes out that throws a major new obstacle 2
in this whole thing, then, yes, you're right, we may have to I
3 meet again.
4 If we have to meet in November, what are some of 5
the -- look, we have met once in Washington, D.C.
6 Washington, D.C.
is a reasonable place to meet if we wanted l
Commission attention because last time two commissioners 7
8 -
came down and actually participated in the meeting for a 9
period of time.
That's doable.
I'm sure by then we may 10 still have some Commission interest in coming down.
That's t
11 one.
12 We haven't been to the Northeast where, indeed, i
13 the public is very interested in this program.
We haven't 14 been to the Midwest.
We haven't been in the South.
- Well, i
15 Maryland is South.
What do you r,1.1 -- you know, we're the j
16 members.
If we want more commentors.
Remember the next 17 time we meet is really to review public comments.
And if we
=
18 want to actually have public -- members of the public to 19 participate, you know, the areas that are of most interest, 20 other than presenting it in writing to us.
You know, it's l
21 open for you all to discuss.
22 We can defer the decision until later to see if we 23 have to meet again anyway, sooner and then we'll decide.
24 MR. SHERIDAN:
Well, let's think about the public 25 comment.
I really think that there's a value to having a
'(
)
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real public -- I think everyone one here would benefit 2
enormously if you had the meeting I had about three weeks 3
ago with the local group of concerned citizens about this 4
whole issue and, you know, they come from all spectrums of 5
life, but most of them are pretty intelligent people and 6
they have a genuine interest in the subject.
7 And I guess what I'm a little bit questioning here 8
is the timing of this and one versus two additional 9
meetings.
It would seem to me that public -- having a good 10 public session before we finalize the draft would be more 11 beneficial than after the draft or is my thinking off here?
12 MR. CASH:
I agree with you, it sounds like a good 13 idea, if we're really interested in having some public 14 comment.
(_)
15 MR. HARDEMAN:
Then we ought to do it during the 16 comment period, not just have everybody send in written I
17 comments, but maybe we should -- if we're going to have a 18 public meeting where the general public can actually have 19 input into this process, then the public meeting should be 20 during the comment period on the draft.
21 MR. CASH:
I would be inclined to do it before we 22 do a draft'and take into consideration then whatever 23 comments that might be appropriate in the draft.
If you do 24 it --
25 MR. HARDEMAN:
I don't have a problem with --
a
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i'j ANN RILEY & ASSOCIATES, LTD.
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CHAIRMAN MOHSENI:
Well, this was one of those.
()j f
2 Supposedly the one in Washington was one of those.
It was 3
open to the public for public to -- of course, we haven't 4
gone all over the country where the interest is.
That's a 5
different issue.but supposedly --
6 MR. HARDEMAN:
And probably haven't gone out of 7
our way other than messages on the NRC Web page and various E-mail messages to really advertise that we were having a 8
9 meeting.
10 MR. GODWIN:
Yeah, but the public and the press 11 was here based upon a notice back in February so it was 12 clearly out.
13 MR. SHERIDAN:
Let me just give you another 14 thought here and you can do with it what you will, but we're
T k/
15 a pretty educated community when it comes to all things
{
m 16 nuclear and you all probably are well aware that all of the i
17 submarines or most of the submarines over the years have 18 been built in our area, right, within the four, five miles 19 of the plants.
And I think you're likely to hear a lot of 20 different thoughts and comments.
I mean, a lot of it, if 21 not all of it, has been brought up here at one time or 22 another over the past two meetings but it seems to me we'd 23 all benefit somewhat if 50 to 100 people sat in front of us l
24 and questioned us.
25 I know I'd benefit.
I think Ed would benefit.
I l
D (j\\
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828 1
think it would give you folks a sense of the dimensions of
()
2 the problem that we deal with in New England.
3 CHAIRMAN MOHSENI:
Let me offer you a solution 4
here if you agree.
If we met, a third time we meet we have I
5 allowed for three months the public to review the draft 6
document and then the next time we meet wherever we meet, 7
somewhere where there's a potential for more public 8
interest, we will have one day initially for public comments 9
if they choose to provide additional comments that day.
10 Then we have four days of the week left to now sort out 11 through all the comments and give directions to each other 12 in terms of -- agree with each other on how we're going to 13 revise the document and allow us another month to do that i
14 and get everybody's approval prior.
O 15 So there's a one-day, if you will, from 8:00 to 16 5:00 public comment period in addition to the three months i
17 that they have had to look at the draft document.
It's 18 necessary for them to look at something, for them to provide 19 comments.
Right now, you know, the comments they make are 20
. based on our transcript.
The document put in front of them l
21 is really the consolidation of all the pros and cons.
Yes.
22 MR. GODWIN:
If we're really going to try to get 23 public comments and really actively going to do that as 24 formal public comments, it's probably better to not start it 25 at 3:00 to'5:00 but have it some time where it overlaps and J
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
[T
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l i
829 1~
the people that work during the day would have an r~
(,N) 2 opportunity to comment.
l-p 3
MR. HARDEMAN:
Or hold it as a dual session.
4 MR. GODWIN:
3:00 to 9:00 or some period of time
)
l 5
like that because --
l 6
CHAIRMAN MOHSENI:
Good point, good point.
l 7
MR. GODWIN:
-- you know, a lot of people work and 8
they're concerned and we'll give them a chance to be there, 9
too.
10 CHAIRMAN MOHSENI:
Absolutely.
11 MR. HARDEMAN:
I don't think we may want to not 12 hold that hearing at the end of the comment period, but very f
I 13 early into the comment period.
If we're going to have that 14 hearing after the draft is available, we need to hear those O
15 i
comments early on so that we've got enough time to digest 16 them and take action on them if necessary, i
17 MR. McNUTT:
Aby, as you probably know, I held a 18 public meeting when we were discussing the FRPCC policy and 19 you know, we noticed that I guess in the Federal Register.
20 We got representatives from seven individual states.
Jim 21 represented the CRCPD.
We had the Nuclear Energy Institute, 22 three public, national public interest groups, former 23 employee of NRC, a renowned physician from Princeton 24 University.
We had quite a mix.
25 Of course, we had Peter Crane, who filed the 1
I
. ()
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petition, representative from the American Thyroid (q7 2
Association and NIH.
So we attracted those kind of people 3
and I thought we had probably the best discussion of the 4
issue that I'd ever heard up to that point.
So I think 5
after we have a solid draft put together and an opportunity l
6 for people to see it so they can, you know, organize their 7
comments, then sure, then I think we ought to have a full l
8 blown public meeting.
9 CHAIRMAN MOHSENI:
I agree.
If everybody agrees 10 the question is when to -- in order not to meet more than 11 one more time, if possible.
I mean, I like you guys, but 12 hey.
We initially proposed three meetings of the KI Core 13 Group in the sequence I just described.
If we're going to 14 have the public meeting is it possible that the third
)
15 meeting would include the one day, whatever hours that are i
i 16 convenient for the public to address, whatever day of the 17 week that you choose, you may do it, whatever you want, but I
18 rueet up front but having given them two months, three 19 months, whatever, for them to take the document, as Bill 20 said, the solid draft, review it and so that they appear 1
21 before us.
l 22 They have had a chance to provide their comments 23 in writing and now they can also appear in person and make 24 their case.
And then following that, we, you know, close 25 the public -- the door to the -- it's not a public hearing O~'
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any more in the sense that they speak --
()
2 MR. GODWIN:
A public meeting but not a public 3
hearing.
l 4
CHAIRMAN MOHSENI:
Yes, it's open to the public.
l 5
We'll continue reviewing just the way we do it now and 6
review all the comments for the next following four days and
(
7 give -- provide our own directions to the implementers to go 8
back and revise the document accordingly and send it to the 9
Commission for approval and public -- for final issuance.
10 Okay, so that means, the next time we meet we want 11 to include the initial first day as a public day, a meeting 12 for the public to actually -- and just there and sit there 13 and listen, take in all the comments that they have.
14 MR. McNUTT:
I allowed each presenter 10 minutes.
(
15 CHAIRMAN MOHSENI:
Yes, yes, we'll go with a
]
16 format similar to what you had, Bill, to allow as many 17 members of the public an opportunity to provide their 18 comments in person, orally, if they choose to, obviously in 19 writing and then our job would be to sort through them the 20 following four days.
21 MR. CASH:
Tony is much more in touch with the 22 people that are concerned about this in his area, for 23 instance, in the Northeast and probably has a better feel 24 than we public -- other public servants that are not elected 25 do have on whether to have this type meeting or not.
I ANN RILEY & ASSOCIATES, LTD.
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E 1
1 832 l
1 think he has a good idea about having that.
I think you had (R.
J-2 a good idea about having before the -- or when NRC would pay 3
attention to it if we were in DC.
I think that should be 4
the fourth and final meeting but I think the third meeting 5
should open with a public comment, but I think it should be 6
an earlier time than you're talking about and it should be 7
perhaps, in the Northeast as Tony had suggested.
8 MR. HARDEMAN:
Just based on the schedule that 9
I've heard.here, if we prepare a draft by late June and you 10 said perhaps publish it in the Federal Register the 11 beginning of August then probably maybe towards the early 12 part of September perhaps just right after -- well, not the 13 week after Labor Day, the week of Labor Day but maybe the 14 following week might be an appropriate time.
It gives O(_/
15 everybody a little over a month to take a look at the draft, 16 try to see where we're coming from, formulate their own 17 thoughts and then come provide them to us.
18 MR. SHERIDAN:
The weather is better, too.
19 MR. HARDEMAN:
yeah, the weather is better up your 20 way in September than in November, but that didn't factor 21 into my decision making at all.
22 CHAIF AN MOHSENI:
That'would mean two meetings 23 though.
24 MR. HARDEMAN:
Yes.
And I concur with Mike.
I 25 think that we ought to go ahead and just bite the bullet and
()
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1 say that it's probably going to take a fourth meeting to tie 2
up all the loose ends and put this thing together.
3 CHAIRMAN MOHSENI:
Yes, Ed.
4 MR. WILDS:
You know, on the third meeting, I l
5 mean, I was just thinking, do we need a full week.
I mean, 6
we're still going to be receiving written public comments if 7
we do it in that time frame.
We may want to meet for two 8
days, one day, to have the public hearing and one day --
9 A VOICE:
Two or three days at the most.
10 MR. WILDS:
Yeah, not do it the full week.
11 MR. GODWIN:
We really need to think about this 12 because if we're all trying to put together the final 13 version based upon the comments received, both the written 14 comments and then also pick up the public comments it almost 15 has to be at the end of it because if you get the public 16 comments then and you make your adjustments, you got to wait 17 until the public comment, written comment period closes, 18 then you've got to rewrite it again.
19 So, you know, you ought to try to avoid that.
20 CHAIRMAN MOHSENI:
Yeah, that's what I was j
thinking that maybe at the end of the comment period just in 21 22 case somebody hasn't provided the written comments to us,
~
23 and especially in the Northeast people would like to make 24 sure that they're heard.
Thank you very much, folks.
We'll 25 see you later.
Have a nice trip.
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If we can have just one more trip, it saves me a (O
,j 2
lot of extra administrative stuff.
Now, if it makes sense 3
what Aubrey said, that it has to be at the end of the 4
comment period that we meet with the public, then we can 5
join the two meetings together in one.
6 MR. HARDEMAN:
And then you're back to November 7
again.
8 CHAIRMAN MOHSENI:
Unless we can do a quicker 9
turnaround on the initial publication.
10 MR. HARDEMAN:
There's sufficient press that you 11 could put a 45-day comment period on it with little 12 difficulty but I don't think we need to do that.
13 MR. GODWIN:
This will be a major document.
14 MR. HARDEMAN:
Right.
15 MR. GODWIN:
Major policy and it ought to have the 16 apportunity for people to come up and consider their 17 comments.
j i
18 CHAIRMAN MOHSENI:
Well, it's not a major policy, 19 Aubrey, but yes, major document.
So we said this is not i
20 policy.
I don't want others to feel like we're making 21 policy for them, but, yeah, it's a major document that --
22 MR. GODWIN:
The whole package is making policy.
23 CHAIRMAN MOHSENI:
Yes, okay.
Yeah, I think 24 you're right.
We've got to give the public enough time to 25 review and three months is reasonable.
It's not --
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1 MR. SHERIDAN:
And I really would argue then, if
(,T l
/
2 you're going to give 90 days for th.e public to review the
{
3 document, there's always -- I always have a problem when I 4
get a draft document.
There's so much work that goes into it that it seems to me you're really being much more open by 5
6 giving -- before you go back to your commission, before you 7
give a final draft document, to get a public meeting, to 8
advertise a public meeting, you're going into it with a much 9
more open attitude, I think and I would argue for the fourth i
10 meeting, shorter meetings, perhaps not a week long.
I mean, 11 but I'll live with whatever --
12 CHAIRMAN MOHSENI:
Okay.
i 13 MR. HARDEMAN:
Yeah, that's the thing, you hold 14 three meetings, you know, hold a third meeting, I'll be at p,
15 the third meeting.
You hold a fourth meeting, I'll be at 16 the fourth meeting.
17 CHAIRMAN MOHSENI:
Okay, let me then actually --
18 MR. SIMPSON:
Excuse me, I understand this to be a 19 national policy documant we're talking about here.
20 CHAIRMAN MOHSEN1:
No, we said up front this is 21 not a policy document.
22 MR, SIMPSON:
Not a policy document, but it's a 23 guidance document.
24 CHAIRMAN MOHSENI:
Yes.
25 MR. SHERIDAN:
A guidance document and I think l
l l
l
'O)
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1 that's a serious matter and having an afternoon or an D(,,1-2 evening with John Q Public walking in and banging the table 3
and which you'll hear or see a little bit of it in New 1
l 4
England, and it's an experience that especially those of you 5
who haven't been there, you really need to see this because 6
I think it will give you a real sense of what Ed has to deal with when he sits down and tries to create a policy for the 7
8 State of Connecticut.
9 MR. HARDEMAN:
And it's fair to assume that 10 although the comments may relate to the document that 11 appeared in the Federal Register it's not fair to assume 12 that everybody has read the document ir the Federal 13 Register.
They'll just know something about the issue.
14 MR. SHERIDAN:
I hate to disappoint some of you, I 15 hope I'm not but there's very few people who read the 16 Federal Register.
17 MR. HARDEMAN:
Who read the Federal Register other 18 than a sure cure for insomnia.
19 MR. SIMPSON:
Could I suggest that I think 20 probably it would be best to have the public meeting during 21 the public comment period so that those comments are a part 22 of the Federal Register submission and that perhaps we would 23 take let's say the afternoon of one day and the evening of 24 one day for the public comments.
The next day we would get 25 together just to review what we have heard from those i
Ii-O l t
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-j 837 1
people, stop there.
Then let the rest of the public comment 2.
period go and at the end of the public comment period, after 3
everything is in, after we've had a chance to look at not 4
only what we heard and what was turned into us there, but 5
what came through the public comment period, at that point 6
would be the time we would come back together and my guess 7
is that one is probably going to be a week long, where we'd 8
have to'go through that to come up with the final document.
l 9
MR. CASH:
It sounds like you have an executive 10 decision to make.
11 CHAIRMAN MOHSENI:
I'll go back and actually 12 discuss this and I hear, you've got a good point.
We have 13 informed the Commission that this would be a three-meeting 14 deal.
A 15 MR. SIMPSON:
And I realize there's very little 16 difference in cost to the Commission between a two-day 17 meeting and a week meeting, because your cost and your per 18 diem, but that wasn't what I was thinking of.
I was i
19 thinking the best use of the information, getting it inside 20 because theoretically, if you have it after the public 21 comment period has closed, that's not really public comment.
22 It's -- you know, so --
23 MR. GODWIN:
It's got to be the tag to --
24 MR. SIMPSON:
Yeah, it's got to be within the 25 period at the very least.
l 1
\\
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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
838 1
CHAIRMAN MOHSENI:
No, that's fine.
Again, we can
(
2' do it with one meeting if it's really, end of the comment 3
period.
We meet and then the next four days --
4 MR. SIMPSON:
I don't think so.
I think after the 5
public comment period we've got to have all the public l
6 comments at home to review that.
To all of us sit around 7'
here and try for the first time to look at all this stuff 8
that's out there or even just the testimony that we've 9
heard, that's going to take a lot longer than if we've had a 10 chance to go through it, mark it up, be prepared to come in 11 and discuss the salient points.
12 MR. CASH:
Let's discuss it eyeball to eyeball.
13 MR. SHERIDAN:
Let me make one other point.
I 14 think the Commission if they recognize that the -- that we
(
15 feel it's important to be in New England for a meeting, 16 particularly in Waterford, they will agree to it without any 17 doubt or consideration.
We just had two commissioners there 18 two weeks ago.
They're very concerned about their image in 19 our area, rightfully so I might add.
No, I should add in 20 fairness, they have worked extraordinarily hard to change 21 that and having this meeting in New England in Waterford, 22 would be in their best interest and I think they'd buy into 23 it immediately for that reason.
24 CHAIRMAN MOHSENI:
And we -- the fact that we 25 would like to meet in Waterford next, it's just a question
()
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Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
839 1
.of whether or not we need to meet twice or just once.
Fine.
()
2 I'll take that and see where we can go with that.
3 MR. HARDEMAN:
We're looking tentatively then at 4
the week of the 13th of September.
5 MS. KEY:
Any other week in the entire world.
6 CHAIRMAN MOHSENI:
Pardon?
7 MS. KEY:
I can't do it the week of the 13th of 8
September.
9 MR. HARDEMAN:
How about the following week, the 10 week of the 20th?
i
-11 MS. KEY:
The following week is fine.
{
12 CHAIRMAN MOHSENI:
The lost source exercise is 13 that week by the way.
14 MS. KEY:
Okay, how about the 27th?
15 CHAIRMAN MOHSENI:
I'm open.
It's okay.
16 MR. SHERIDAN:
September 27th.
17 MR. HARDEMAN:
The week of the 27th.
If it's a 18 two-day meeting it would be like noonish through the 28th.
19 MR. SHERIDAN:
I'll relight the fire.
20 CHAIRMAN MOHSENI:
So it's a two-day meeting.
It 21 would be the 28th and 29th, so leave 27th for travel and 22 public meeting.
Now that's -- okay.
The hours we'll talk 23 about later so it allows the public maximum --
24 A VOICE:
Yeah, presumably the afternoon of the 25 28th and 29th.
j ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C.
20036 (202) 842-0034
[c 840 1
MS. KEY:
There was a point brought out that we
()
2 were not including the week of Labor Day, that earlier week 3
in September.
If it's only going to be a two-day meeting, 4
that might be a possibility.
l 5
CHAIRMAN MOHSENI:
Let me ask, if we come to I
6 Connecticut, is there a place that you -- instead of a 7
hotel, can we go to one of your offices?
8 MR. SHERIDAN:
Yes, we would be happy to have 9
space at the town hall made available.
10 CHAIRMAN MOHSENI:
Okay.
11 Mk. SHERIDAN:
Or even the plants have a wonderful 12 public room.
j 13-CHAIRMAN MOHSENI:
Well, let's avoid the plants if 14 possible. _Let's just go to the official government local or
(<~
\\
\\j 15 state.
16 MR. WILDS:
For the people that are interested, if 17 it was in Waterford rather than Hartford.
18 MR. SHERIDAN:
Everybody knows how to get to the 19 town hall at this point.
20 CHAIRMAN MOHSENI:
Okay, we'll talk about the 21 details later.
Okay.
22 MR. SHERIDAN:
Yeah, we'll keep your expenses 23 down.
We can provide whatever services --
24 MR. GODWIN:
We'll sleep over at yo'tr house?
25 MR. SHERIDAN:
No.
Q.
Ig.
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20036 (202) 842-0034
i i
1.-
841 1
CHAIRMAN MOHSENI:
Okay, thank you very much.
()
2 MR. SHERIDAN:
I would like to say thank you to 3
our transcriber.
I don't know how she put up with all our 4
gibberish here.
5 CHAIRMAN MOHSENI:
Yes, indeed.
Thank you all.
6
[Whereupon, at 11:30 a.m.,
the 'eeting was 7
concluded.]
8 9
10 i
11 3"
13 14 15 16 17 18 19 20 21 22 23 l
24 1
25 l
l'O.
ANN RILEY & ASSOCIATES, LTD.
Court Reporters 1025 Connecticut Avenue, NW, Suite 1014 Washington, D.C. 20036 (202) 842-0034
f I
REPORTER'S CERTIFICATE i
This is to certify _that the attached proceedings j )
before the United States Nuclear Regulatory Commission in the matter of:
l NAME OF PROCEEDING:
POTASSIUM IODIDE (KI)
CORE GROUP MEETING
):
1 CASE NUMBER:
PLACE OF PROCEEDING:
Tempe, AZ were held as herein appears, and that this is the original
)
transcript thereof for the file of the United States Nuclear Regulatory Commission taken by me and thereafter reduced to typewriting by me or under the direction of the court
-reporting company, and that the transcript is a_true and accurate record of the foregoing proceedings.
ALM 6
ohn Hanley
{
Official Reporter Ann Riley & Associates, Ltd.
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