Oak Ridge Reservation: Public Health Assessment Work Group

Public Health Assessment Work Group

June 3, 2002 - Meeting Minutes

Present:

Kowetha Davidson, Acting Chair
David Johnson
Susan Kaplan
James Lewis
LC Manley
Jack Hanley, ATSDR
Karl Markiewicz, ATSDR (phone)

Summary

Jack Hanley: This is the meeting of the Public Health Assessment Work Group on June 3, 2002.

Kowetha Davidson: The meeting is called to order. And we will have a role call. We can start down on the end with Mr. Manley.

LC Manley, David Johnson, James Lewis, Jack Hanley (ATSDR), Kowetha Davidson, Susan Kaplan.

Jack Hanley: Is there anyone on the phone?

Kowetha Davidson: No one on the phone. We will get their names when we hear the beep of the phone.

It doesn't look like we have minutes from our last meeting to approve, so --

Jack Hanley: No. I'll have to talk to La Freta (Dalton) about that. I don't know the status of what they're doing for that.

James Lewis: We do need to document the fact that she took the minutes back -- she took the tapes back to Atlanta.

Jack Hanley: She did?

James Lewis: Supposedly to generate the minutes and I hope that they understand the level of detail that we would like. Last time they took a set and we never got them back.

Susan Kaplan: Oh really?

James Lewis: Not to my mind.

Jack Hanley: No. Bill made -- took the minutes. Got the tapes back and we did them here.

Kowetha Davidson: Jack, you want to do the PHA update?

Jack Hanley: PHA update. I'll try to keep it short. Karl Markiewicz has moved to Houston. He's active again. He's going to be splitting time between Oak Ridge and working with our regional operations out in the Texas area. He has an office -- and this is kind of a little experiment with ATSDR with having him out in the field like that. But he is working on a plan to pick up where he left off when he thought he was moving on. He has picked up on the screen of the current exposures - that's the electronic data from 1990 to present and that's the ORRHES data. So we're working on a project plan to get him up and running again and I have some target dates to meet. I'm working with management to try to get uranium moving, again, since Mark Evans is working on the Livermore Lab. I need to work with him within his schedule in order to get uranium going again. And then Paul (Charp) is working on the iodine, currently. So that's the status of things right now.

Kowetha Davidson: So what's after uranium?

Jack Hanley: After uranium would be mercury, likely. Mercury. And one of the things -- just to kind of explain how we see this thing going, it's going to be like chapters in a health assessment. We're going to have an overall health assessment for the reservation. And in that formal document we're going to have what we call focused health assessments on iodine, on the screening of past exposures, on the screening of current exposures, on uranium and on each of the contaminant concerns, ground water and other issues, specific issues. And we have focused health assessments on each of one of those. Each one is going to be like a chapter when we bring this thing together. We're not just going to dump it all on the subcommittee and the community at one time. We're going to go through this process we've outlined and going to take some time and move through it. But you're going to know the answers before we get to the end. You're going to know what the end of the book is before we finish, before get a publication out because you're going to be involved throughout the whole process.

LC Manley: Fantastic. In a participatory manner?

Jack Hanley: Yes, sir. You have a question?

Susan Kaplan: Yes. How are you planning to present the overall picture on one piece of paper? There has got to be a way where you can do a time frame, show the contaminants. Because iodine was only an issue in the past. On the other hand contaminants in the ground water are an issue today if you're drinking well water. So there is a visual way to show that. How are you going to do that?

Jack Hanley: If that comes out at a group that we need to visually communicate, we could try to develop the tools to do that.

Susan Kaplan: I'm planting that seed that you can think about visuals.

Jack Hanley: One of the things that I plan to do is on the web, with the web site, which is making progress and if you look at the web site we have a section in there on epidemiology. It's by topic. And we're trying to follow up on your lead.

We do everything by meetings, you see. Everything is by meetings. We are trying to do is turn around -- chronologically we have everything but we are going to try to also cross- reference by topic on the web site. So if you want to know what the needs assessment, you go to that one page and it's going to have all the presentations. On the screening -- that's what I need to develop -- everything on the screening is going to be on one thing on the web. So we're also trying to do it by copy.

Now visually, that's another challenge that we could try to do down the road.

LC Manley: Jack, will you have any studies on contaminants of current concern? Well maybe not current, but continuing concern? Things that we will -- there will be a need to continue at DOE with?

Jack Hanley: Over the long term? Future?

LC Manley: Yes. So something that you can tap a load of contaminants on a continuing basis.

Susan Kaplan: See he could do that with the visual if he gave a time line for 1940 all the way up to the future. You can visually show it.

Jack Hanley: We deal with future issues. However we have to put the caveat that we have to deal with what we know today. If that situation changes we would have to reevaluate it again in the future.

Susan Kaplan: But it would be nice to show the variables. What it is going to impact.

Jack Hanley?: Yes.

Kowetha Davidson: The current exposures are -- unless something is done to mitigate them, are the future exposures.

Jack Hanley: Correct. But if you have -- an example is Paducah (KY) Gaseous Diffusion Plant (PGDP). One of the situations is the tanks. They have a lot more hydrogen fluoride tanks and they're getting old and what they're going to do with them and there are potential situations with that. And so we discuss some of that in that Paducah document.

LC Manley: That's one of the continuing things that I was thinking about. We have contaminants that we basically have contained right now. But it could create some problems in the future.

Jack Hanley: And if that happens in the future Mr. Manley, we could come back and discuss that specific issue.

LC Manley: Wonderful.

Jack Hanley: There are provisions for handling that.

LC Manley: It's like that "if then" clause. That "if, then" clause, then you proceed.

Susan Kaplan: The problem is what triggers it?

Jack Hanley: Just a request.

Susan Kaplan: From the public. For the public to be vigilant?

Jack Hanley: Yes.

James Lewis: A couple of comments. Before you talked about the web site -- "Nine Counties - One Vision." If you go down to one of the links and click on "Nine Counties - One Vision" - look how that site is set up. Because he was talking about the issues. Look how they did their brainstorming with all of their meetings and how they captured all the issues. So there is a subset of links. Go to "Nine Counties - One Vision," go through those, look under errant(ph) water quality and just look at the massive amount of information they pulled out of there. One of the things I thought as Jack was talking, the idea of staying somewhat focused on the subject -- rather than by meetings -- they have meetings but they have a subject. Based on the subject, where did you pick this up from which meeting? So I think there are some ideas and I suggested to La Freta (Dalton), "Nine Counties - One Vision" look at that.

Jack Hanley: Also we are going to have TDEC (Tennessee Department of Environment and Conservation) present the data at the next meeting and the ORRHES folks talk about the electronic data that DOE has in its database. So those are the databases we will be using for current exposures.

Susan Kaplan: Is there a videotape? There is a videotape made of every meeting. Can I check it out?

Jack Hanley: Yes.

Susan Kaplan: So I could check the data out?

Kowetha Davidson: You mean there is one meeting that we are going to have?

Susan Kaplan: I'm not going to be there.

Jack Hanley: Oh yes. That's why we do it. That's right.

Kowetha Davidson: I was hoping you didn't mean -- you weren't talking about the last 2 because I have -- well, not the last 2, but September and December. I still have those at home.

Jack Hanley: You use them to go to sleep?

Kowetha Davidson: No, it's last June and September I have at home.

Jack Hanley: June and September, right.

James Lewis: Why are we on the 6 and the 9?

Kowetha Davidson: Say it again.

James Lewis: June being the sixth month and September being the 9^th month, what's the significance of this?

Kowetha Davidson: It was the subjects.

James Lewis: The subjects?

Kowetha Davidson: Yes. I took the tape home because of the subjects we discussed on them.

James Lewis: Okay. So that's why it's scheduled in June and September?

Kowetha Davidson: No. I said I had those tapes. The meeting -

James Lewis: Yes. But I'm just -- the timing. The 6^th month, June and the 9^th month September.

Kowetha Davidson: Oh. We were doing quarters last year.

James Lewis: Oh. I see.

Susan Kaplan: So you're trying to find some correlation?

James Lewis: Correlation?

Kowetha Davidson: There is nothing mystic about it. It's mathematics.

James Lewis: To me I guess there were some outstanding issues that I thought were raised in last work group meeting that I think we need to look at. I know that we don't have minutes for those, but there was a lot of discussion about, number one, Susan Kaplan had done a lot of work. We talked about what did the recommendation say. The recommendation we made on endorsing the screening. Did we have some action items left in those minutes? We don't have the minutes, but there were some key things that we discussed that related to that. And I don't know if you've done anything in that area. I thought that was of some importance because it bothered me to the point that I went back and made a copy of the recommendations. I know we're out of the sequence of work but I think we need to read the recommendation.

Guess what I want to do, I remember that being -- what is your interpretation re as it relates to getting back to the issue of whether or not we had tabled certain contaminants. What did we get when we bought off on the screen process? I think we ought to take a look at that and see where we are.

Susan Kaplan: It says it begins with using the ??... screening process.

James Lewis: Yes. But what else does it say? The endorsement begins with the use of the process and its associated findings. Come on down here it says the overall contaminants will be added if they are supported by a scientific rationale and relevant data and are deemed to be credible or asked after review or input from ATSDR. That to me was -- I felt like the key contaminants of concern was identified on here. The reason I go back to that is this was attached actually to that document, where we had the high priority concerns and ??... and the reason I brought that up is that I thought that for purposes of moving forward we were going to challenge ATSDR in going ahead and getting the mercury and all these key issues out of the way. That did not preclude that if someone had a concern or a contaminant that they were concerned about that "had been screened out" but they had rationaled them out on objective evidence, the concept was to put it on the form -- this was what I envisioned -- and then you could submit it to a subcommittee or a work group for evaluation and then if we had the rationale, then we go back to this, which is the basis. And we developed this, and that is that you would identify the issue and that could be a contaminant that someone thought was screened out: Identify, "provide with a rationale, supportive information, previous action taken and then, last but not least the suggested action or solution." I guess that if we can do this, then we have to have this type of information. I'm getting back to you passing things out I believe a week or two [ago] to Peggy and the others. If this is my understanding of the way I thought the process was intended to work.

Kowetha Davidson: I passed those forms out. I did.

James Lewis: Right. And as we go through here -- I'm not saying that we're perfect. I'm only giving a good example which I think we have here.

[interruption. Telephone ring]

Karl Markiewicz: Hello, this is Karl Markiewicz.

Kowetha Davidson: Hi, Karl Markiewicz. This is Kowetha Davidson.

Karl Markiewicz: Sorry I'm joining you a little late.

James Lewis: Let me give you one example. I thought that what they found at X-10, remember the additional data? That you were looking at as relates to iodine?

Jack Hanley: Oh the DOE. Susan Kaplan you're familiar with that report. What was it? The oversight DOE internal --

Susan Kaplan: You're talking about the data, right? I have that data.

Jack Hanley: No. Yes, the iodine data?

James Lewis: The iodine data.

Jack Hanley: Is that what you're talking about?

James Lewis: That's what I'm talking about. That to me was an example of additional information that was brought up. In other words we already, I thought passed that point. You found something, and maybe we haven't agreed upon it but you all gave us a presentation and I guess it was ATSDR's right to pursue it if they want, but to me from the presentation that I heard, it had I think supporting information and enough justification and rationale that this information that they gave to us may have an impact, a major impact on the findings. You know on what conclusions we might reach or they might reach. Now that to me is definitely a candidate that could follow into something that could change things. But my question is how do we -- if we're not in agreement on them moving forward on the key ones that we've agreed on the screening process, then how are we going to continue to deal with the others if they're popping up. I mean we have to take [a] stand someplace. Does that make sense?

Susan Kaplan?

LC Manley: Going back to Pete's statement the last - most eloquently said, the lay person does not - concern is not with the sophistication, the specificity of the process. They want results. And so when we look at this and you won't be able to fill out this questionnaire essentially, and rationale and say fill out who is going to aide and assist the person to fill it out?

James Lewis: That's what I thought this office will do, Bill Murray was here to do if someone has an issue like that. In addition to that I do separate what I'm going to say [is] the lay public and some of the technical people in the room. I also took Kathy Thiessen. Kathy Thiessen raised a good issue too. Could we -- in going back and looking at this. Kathy Thiessen submitted a written document with her concerns associated with us adopting the screening program. And what I did is relate it to that. So I went back -- I'll give you some idea. This one is going to be hodgepodge because --

Susan Kaplan: While you're looking for that.

See I have a problem with this group adopting a screening method or adopting or endorsing theirs. We are a lay group for the most part. We are not qualified to do this. So you may push something through or it may get pushed through and we may get additional information after talking to the professionals or whatever and find out --

Kowetha Davidson: Then they should have come forward.

Susan Kaplan: Or.

Kowetha Davidson: They've got to come forward. If they don't how are we going to get that information from them?

Jack Hanley: Have them fill out the form. Hand them a form and have them fill it out. If they're technical and they're that sophisticated they can provide a rationale and stuff.

Now your questions and the concerns that you brought to the table will be addressed by ATSDR. That's separate from what this work group does. You understand? That material you brought. We're going to look through it, we're going to tease out the concerns that are in there and you have a list of them and the ones that the work group, and we will address those in our evaluation of iodine and have answers for those.

Susan Kaplan: But see James sounds to me like he's saying ORRHES made a call on this and we're going to take their numbers by damn and we're just going to go with it.

Kowetha Davidson: No, we endorsed a process. We didn't endorse any numbers. We endorsed -- it's something totally different in endorsing numbers than in endorsing a process.

Susan Kaplan: It sounds like he thinks we endorsed this process that said that we adopted everything that ATSDR said.

Jack Hanley: Yes. That's what it says up there.

Susan Kaplan: But there were a lot of concerns about it -

Jack Hanley: And we addressed those.

Susan Kaplan: And you said that you would address them.

Jack Hanley: We addressed -- the ad hoc group looked at those and they came to me and I gave them directions to go and address all those. And those were presented in a work group meeting and in a subcommittee meeting and when ATSDR -- when I write up that section on screening, and that's what I need to do next, on that past(?) screening, write up that section. I will address those things. I addressed them last year in my 3 presentations. Many of those concerns brought up by Kathy and others, I addressed those in my presentations. And when the ad hoc group came to me I said look, this is where I addressed this, this is where I addressed this. I went back to my presentations and pointed that stuff, showed them the documentation. So those issues I feel were addressed.

Now if there are any others that are outstanding that they have, we have two case files right here. They have all the concerns, they have all the issues that the ad hoc group worked through and that the work group worked through and those are pretty much addressed.

Now if there are some others they should be written up. And Kathy developed this and we felt like we addressed those.

James Lewis: When I looked at this, I used this as an example. This was Kathy's original letter that came in to us and I'm going to show you I'm just going to flip through it pretty quick. And I'm going to go through -- there were some key items that she identified. What I did was, I actually went back -- and you'll see roman numeral II, roman numeral IV -- and what this was, was an attempt -- and I'll come back to this but I just want to show you the letter first -- I went back to see how that would fit our form. She candidly submitted it to us. And what I found, I thought she actually did a pretty good job originally. And in my presentation I was planning to give, this was -- when we took all those concerns, just like you were talking about -- I'm not going to say we went as detailed as -- but we took the major hitters. And these were Kathy Thiessen's issues. We documented, we found this, we looked at this and we had developed some responses for each one of these. The one outstanding issue that we did not get to had to do with trying to determine the traceability to the document where they found the additional information. Because she actually made a reference to this book right here. Remember the discussions on that? Okay and she wanted to know that.

Now I know that Bill Murray actually sent an e-mail to the author of this to get those. But as far as the rest of the information that was concerned, I thought we did a pretty good job. So what I'm getting back is to a process. There are two processes: There is the process that we're using to screen concerns but at the same time what kind of process do we use after we've passed a particular milestone to handle other issues that may be raised. And my point is that I really feel that we have to get to a point so we can move and I think we have to do things like -- especially from the technical experts. I'm not saying a person can't stand up and speak but do we continue to entertain -- some people will come in off the street with, I'm going to say the Owen Hoffmans and people of the world --

Susan Kaplan: They deserve to be --

James Lewis: They can be heard and they can be -- I'm not -- but they should do this. Put their issues together and submit them. When we judge as a group what we want to do and at the same time it goes to ATSDR. We don't want to look at it. ATSDR can do what they want to do. Or we might ask them to do it and they might not. But this is the way I think to do it.

Susan Kaplan: Well I like the -- you said the tracking method because that way we can track it and enforce and --

James Lewis: Right. And so I think if the issue is credible enough or important enough, they should be willing to fill this out, sign it and then submit it and we can look at it to see how we can fold it into our work and make a call on it. I think that's fair. That's not shutting anybody out.

Kowetha Davidson: The other thing we have to realize to in addressing issues is addressing an issue doesn't mean that you agree with them. You can address an issue and still disagree with them. Because you disagree doesn't mean the issue has not been addressed.

David Johnson: You're saying they still have issues, Owen still has issues with the screening program? Because we received a letter from Kathy -

Susan Kaplan: I gave you the radiations.

David Johnson: Right. The radiation. But we have -- we had a letter from Kathy, we had an e-mail from Kathy and we had 2 e-mails from Owen that we put into the process and we went through their issues.

Kowetha Davidson: I think Owen's issues were all -- I captured everything on iodine 131.

David Johnson: No. I'm talking about the screening.

Kowetha Davidson: I haven't dealt with it.

James Lewis: I thought Owen sent, if I remember right, a formal either e-mail or letter -

David Johnson: He sent e-mails to Bill. And we looked at those.

James Lewis: He sent e-mails to Bill of what his issues were. And we went back and looked at those whereas at a point in time Owen sent him an e-mail.

Susan Kaplan: The other major issue that he has a problem with is that he doesn't know if the minutes were ever corrected that he got Falk's assurance that that would be dealt with and he hasn't gotten --

Jack Hanley: Well, he's supposed to be receiving a letter on that.

James Lewis: My suggestion and recommendation is let's start passing out these forms and they can supply that information so that we can get something in an organized manner.

Jack Hanley: It's hard to catch. You've read the minutes and stuff to get the concerns out. When people get verbose, it's hard. It makes them think a little bit harder when they write it. It will be a little bit more concise, a little bit more direct and I find that to be helpful.

Kowetha Davidson: The thing about it is that if it's a technical issue they can address it the same way that Kathy did in that letter. Whether you have that particular form or not.

Jack Hanley: Kathy's letter was well laid out.

Kowetha Davidson: Just present what your problem is and lay it out and send it.

James Lewis: That way we can have a review committee. We can look at it and see where we are and what we've done and probably deal with it.

Jack Hanley: Do you mind giving Karl a couple of minutes to update where he is and what he's up to?

Kowetha Davidson: Okay.

Jack Hanley: Karl.

Karl Markiewicz: Yes.

Jack Hanley: Are you there?

Karl Markiewicz: Yes.

Jack Hanley: I went through a quick update that you're back with us and you're in Houston and you're getting involved again with Oak Ridge and the screening and developing a -- beginning to develop a project plan to tackle the screening. I mentioned that earlier before you got on. Do you have anything else you want to add to that?

Karl Markiewicz: I'm not sure how in depth you went. Just a couple of things. In the process of reviewing the data the Simms guy and some other people found that there were some -- when the data was transmitted electronically if you did it 2 or 3 times sometimes you'd have a different number of files. So we went back and actually have found some data files that for whatever reason were not transferred properly for different media. So for soil sediment, surface water, we're actually updating all of our electronic files to make sure that we include all of the stuff that is in ORRHES and then we're also adding in the TDEC data for surface water to make sure we have an all-inclusive package.

Jack Hanley: Karl. That problem with the data transfer, didn't we -- our computer folks went back to ORRHES right and notified them that we were having this problem consulted with them and I'm not sure exactly where the problem was -- I hate to say where it was but they got it straightened out, correct?

Karl Markiewicz: Right. Correct. It is straightened out and the guy named Steve whose working with us on this is pulling together data packages one of which is the soil data package and that is the media that I want to -- I have a target date set for the August 20^th subcommittee meeting to come in and present the screening process for organic and inorganic compounds for soil to include both surface and subsurface soil. And that would be the subcommittee presentation and obviously try to come up or call in or we'll have to figure out the logistics on this, but to actually make some presentations to the work group prior to the subcommittee meeting.

Jack Hanley: And you will have maps on that, do you think? To show visually?

Karl Markiewicz: Yes. That's part of the graphics package to have maps. To have summary tables and maps to basically step through the process. What I'm envisioning is going from a big circle to a small circle. From a large amount of data to a small amount of data and just step through the process and use -- maps are, I think one of the best ways to show it but then also to provide summary tables so it's in a concise manner and we can identify the sample, sample locations, sample dates, what studies they were from, all the key information can be in there.

James Lewis: Excuse me, I'm going to have to run. I guess the one thing that I'm concerned about whether it is this group or any group, I want to consider putting a recommendation on the table that we sort of adopt this logic. I don't know if we need to do that formally. We have to do something so that we can capture these issues. I would recommend that we consider drafting something similar(?) to this and getting some examples. We'll work with the public where we can. This is not -- but for a lot of people from the outside to come in -

Jack Hanley: Bill has had a few people come in off the street and fill it out. Walter came in and filled one out. And Bill worked with him on that.

Kowetha Davidson: But I wouldn't want to discourage anyone. They may feel intimidated by those forms. If they just want to sit down and write it on their own paper in their own way that's fine with me as well.

James Lewis: I think for some people I understand that. But I think there are some people out here that really have a lot of knowledge. Sometimes you can make references to stuff that is impossible for us so I think we need to look at the possibility of looking at this and endorsing this as a means. I didn't say the only means, but as an appropriate means.

Jack Hanley: What I like about that is it talks about other agencies and have you contacted them so that we can go talk to them and get a sequence of what has happened in the past so then we don't want to duplicate anything. So that's why it's helpful to -- unless we need to.

James Lewis: And I'm going to leave this. I think we ought to generate an example. I was talking about, like Kathy's. Put it out so that some people will have some idea of what you're expected to do. And depending upon the amount of information you put in here, it's going to determine sometimes how far you go. Because we don't have enough -- I think we need to do that, write that up and again, I would suggest we look at developing guidelines.

Let me get out of here ??... [before you hit me(ph)].

Susan Kaplan: We might do a couple of examples, one example and one comp -

James Lewis: Yes. And develop those and circulate those and establish that as a way to -

Jack Hanley: Do you have any comments to Karl as to what he said?

James Lewis: Yes. Why did it take you so long to get back?

Jack Hanley: Don't answer that.

James Lewis: I'll call you one day. Take care.

Karl Markiewicz: It's just, as you're well aware of everybody understands how the federal government works and it was just a long drawn-out process to try and make this thing work and keep me within the federal facilities program and so it seems like it's worked for the best.

Jack Hanley: We were -- at least I was thinking that he wouldn't be able to do it and then we would have to start all over with someone else but we were able to keep Karl Markiewicz on and I think that's going to work.

Do you have any suggestions, Susan Kaplan, with the mapping and stuff? He presented the maps like he did the last time?

Susan Kaplan: I like the maps. I was the one that was pushing that.

Jack Hanley: I know. That's why I'm asking.

Susan Kaplan: Tables are good too. But the maps really communicate.

Karl Markiewicz: What I'm envisioning is that maps and the tables both are going to be in the public health assessment.

Susan Kaplan: The general public just wants to see the maps.

Karl Markiewicz: Yes. And one thing that I know I'm going to work assistance(?) with in the work groups is when we do or when I do the presentations to the full subcommittee is do we want to do one media, both organic and inorganic, do we want to do just inorganic? Or are going to start at the subsurface(?)? We have to figure out and try to work with -- I want to work with the work groups and try to figure out the best way to present this. Because unless we do one and then the second one people aren't going to understand the process and I think its going to go a lot easier. We can cover more ground in a full subcommittee meeting but for the first one it may take a little longer so we may only get to inorganic or organic, one or the other.

Jack Hanley: Karl, I would suggest that we go along at the pace that the work group feels comfortable with and then once we get it through the work group then we can -- like you said we work with the work group to figure out what's the best way to get this accomplished in the subcommittee. Does anybody have any other thoughts on that?

Kowetha Davidson: Thanks Karl. I'm glad you're back.

Jack Hanley: You don't have a fax machine, Karl at your house?

Karl Markiewicz: No. Not at my house and not at work. Well, I have one at work but it's not ours. It's the EPA's. But if I need it tonight I can't get it.

Jack Hanley: Okay. Kowetha has some handouts.

Kowetha Davidson: I have some handouts. I have been working on a presentation on iodine 131. The issue of combining doses. The Nevada Test Site (NTS) with the Oak Ridge releases. And I started this at our last meeting and I won't go over all the same things that I went over at the last meeting. The only problem is that I can't exactly remember where I stopped. Did I go over the national Academy of Science's (NAS), Institute of Medicine (IOM) review?

Jack Hanley: I don't remember that one.

Kowetha Davidson: I will start there. I guess the last time I just gave background information on the thyroid gland. Where it is, what it does, what is its function, control of thyroid hormone levels, the feedback, inhibition, the hypothalamus and pituitary, types of thyroid cancer, the evidence for the link between thyroid cancer and I-131. And so I guess I can start this time on the NAS-IOM review of the National Cancer Institute (NCI) report and what came out of that. And there are little numbers on these, on each one of those squares and we'll start with number 5.

Jack Hanley: Now the NCI report is the report where they looked at the releases from the Nevada Test Site?

Kowetha Davidson: Of the Nevada Test Site, right. And the focus of their review was the soundness of the NCI analysis, the evidence linking I-131 exposure with thyroid cancer and other thyroid conditions, the estimates of U.S. thyroid cancer rates that may have resulted from weapons tests, clinical and public health responses and directions for future research, and the NAS and IOM kind of divided these things up because IOM was focused more on the clinical issues and NAS more on the technical issues of the dose reconstruction.

Jack Hanley: Excuse me. Dave do you know, NAS is the National Academy of Sciences. I didn't know if you knew that.

Kowetha Davidson: I'm sorry.

LC Manley: That's perfectly all right. I kind of thought that but -

Jack Hanley: And IOM is - what is IOM?

Kowetha Davidson: Institute of Medicine.

The National Academy of Sciences is kind of like the epitome of peer review in this country. If you can get an endorsement from the National Academy of Sciences -- they are a team of experts, highly professional people who are very serious about putting their stamp on things. They don't do it lightly.

Jack Hanley: I'm sorry. Could we -

Kowetha Davidson: That's okay. I decided when I give this report at the meeting then I would like people to ask questions at the time in which they come up rather than come up rather than waiting until the end so we'll go back and forth. The general conclusions from this review, was number one that NCI's -- they thought NCI's methods were generally reasonable. That's National Cancer Institute. That their methods were generally reasonable. There are specific elements that could be questioned but overall they thought that the methods that they used were reasonable and okay. They thought the estimates of collective dose from I-131 were consistent with the committee's analysis and they didn't think that they were greatly over or under estimated -- the levels. The counties specific estimates for the I-131 thyroid doses probably were too uncertain to be used for estimating individual doses. And the other thing they concluded was that -- regarding county specific estimates that they may have little relevance to specific individuals whose critical factors were individual consumption of milk and other foods. Because they thought that using county specific estimates did not relate very well to just individuals in general. That there were other things that were more important. And those things were consumption of milk, particularly goat's milk. Other food sources. And you can look at the age of exposure that these things were more critical to determine a person, you know an individual's exposure rather than just in general specific estimates.

Jack Hanley: These are dose estimates?

Kowetha Davidson: Yes.

Susan Kaplan: What about the calculators that are available? The Hoffman calculator is based on consumption of milk rather than that ??...

Kowetha Davidson: Yes. But they are using the county specific estimates. That's what they are saying, that when you do that you introduce a whole other level of uncertainty when you do that because the county specific estimates -- there is a -- every time you try and go down to another level you are increasing your uncertainty regarding what your answers are. It's not a matter of whether it can be done or not. It can be done. It's just a matter of what do the answers mean once you do it.

David Johnson?: So essentially you're saying that weakens ??...

Kowetha Davidson: Yes. It makes it uncertain.

In fact the way I look at that as a toxicologist is the wider the degree of uncertainty the less you know what the answer is until at some point you don't know what the answer is because your level of uncertainty is too great. You can not associate a dose with anything else if your level of uncertainty is so high. If you're looking at something from one to 1,000, it's somewhere in between that. As a toxicologist that doesn't tell me anything. That's just like saying you're looking for John Doe and he is located somewhere between Oak Ridge and Dallas. He could be in Crossfield or he could be in Texarakana. You have absolutely no idea. That's a very wide range.

Now if you say it's one to 10, that's like saying it's between here and West Knoxville. That puts you in a much narrower range of knowing where you are. It gives you a better clue. So the narrower that level of uncertainty the greater degree you have of where the answer is. Once it starts getting so wide, it gets so wide that at some point it -- to a toxicologist. Maybe to some other people it is different but as a toxicologist it doesn't tell me a whole lot when I'm trying to relate dose to consequence.

Jack Hanley: So how should you use the results? How are they saying you should use the county data that they have? They reported like, this county your dose would have been in this range?

Kowetha Davidson: Yes. I didn't -- I haven't read all of it and I don't know if they said exactly how they should be used except that they thought they were too uncertain to use for individual. But they can be used for areas.

LC Manley: Have we see any real increase in thyroid diseases, cancer included in this particular area? What's this, the 7 county area, 9 county area that we live in?

Kowetha Davidson: In order to actually say that you've seen an increase than you'd -

LC Manley: Compared against something outside the counties -- on the perimeters.

Kowetha Davidson: So whether our incidences are actually higher than they are around?

LC Manley: Yes.

Kowetha Davidson: That would require and epidemiology study to actually give a definitive answer.

Jack Hanley: The registry. The state has a registry and Miss Bounts -- Dr. Bounts is going to come and talk about and we could see does the state have a registry on thyroid cancer and what is it's limitations? How far back it goes, what are the years?

LC Manley: I think that's what the average -- That's what I would be interested in. It doesn't mean a whole lot to me. But when you're dealing with the human subject that and you can definitely prove that the cancer rate is higher in Anderson County than it is in one of the counties outside -

Jack Hanley: Yes. But the thing is they don't know -- no one is out there counting exactly-- no one has counted all the thyroid cancers in the area for the last 20, 30, 40 years. There is no documentation of that. And also the non-cancer effects. That's not being documented either, anywhere. So that's the problem. It's that there is no documentation. And if you remember Lucy's (Peipins) presentation, if you're going to do that and you're going to compare one area to the other you have to set your time frame that you're looking for and you're geographic area, your county, and then you have to make sure you get every one. And there is no record, there is no registry counting -- and we can find out a little bit more about registries at the next meeting.

Kowetha Davidson: And 2, if you're going to relate it to this, it can't just be any age group because adults are not going to be very sensitive to this. They've even found that to be true in Chernoble where the exposures they know were quite high. It's the children who had the really high increase in rate. Not the adults.

LC Manley: Not particularly adults but the fact that the incidence that we are talking about happened long enough ago now to really start showing.

Kowetha Davidson: As that age group, as they grow up -

LC Manley: Yes. That age group, if they were born in the 40's and the early 50's we should be seeing something.

Kowetha Davidson: Yes. That would be the age group that you would have to focus on as far as -

Susan Kaplan: Has that data been gathered? Probably not.

Kowetha Davidson: And so you'd have to have something more than rates in order to do that because you'd also have to also know something about the individuals. We have to know whether the thyroid cancers are occurring in a person who would be exposed at that young age and whatever age they are now as opposed to a person who is 80 years old now who may have been 40 at the time. That cancer -- it would be less likely it would be associated with it because adults are not as sensitive as children are. So you have to know something about the population not just the crude rate, age of the population.

Susan Kaplan: What is the plan with this. Are you actually going to make a presentation at the next meeting and a vote?

Kowetha Davidson: We haven't gotten, we're going through it and then you can see what's there. It's up to the work group to decide what's going to -

Susan Kaplan: Because I'm not going to be at the next meeting, which I'm really unhappy. If this major issue comes to that meeting. I think Dr. Owen Hoffman of SENES needs to review this.

Kowetha Davidson: Hoffman can -- I've got some copies here. If he wants to look at it that's fine. But anyway, on to the next issue. These are things that I've taken directly from these particular, from the NAS's book. The next one is that individual specific estimates of past exposure to iodine 131 from the Nevada Test Site are available but often uncertain, " often highly so because critical data are often available." That should be are of questionable reliability. And they go on to say that a small minority of the population has children, young children at the time of testing who routinely drank milk from backyard cows, especially goats, had a significant exposure. And that individual specific estimates of the probability of developing thyroid cancer -- this is the next one -- from exposure to fallout from the Nevada testing program are uncertain to a greater degree than the tests -- than the dose estimates because of the additional uncertainly, in particular about the cancer causing effects of low doses of I-131." And so what they're saying is that there is uncertainty with the dose estimates but there is an even greater degree of uncertainty when you translate those dose estimates to risk estimates.

Jack Hanley: That was an issue that Ed (Frome) had last year. It's one thing to take estimated dose and then you convert that dose to risk numbers you have a whole other set of assumptions-

Kowetha Davidson: -- of assumptions and then when you're in here, you're increasing your uncertainty when you go to that next step. And this is what they're counting on here.

Jack Hanley: The first assumptions are how much did you get. And then if we make all those assumptions and figure out how much did you get, the next set of assumptions, what is your risk? And it's a whole other theories and risks, numbers and assumptions. I remember him having concerns about that.

Kowetha Davidson: The next thing is just some things that I took from Owen's (Hoffman) presentation on June 11^th and on a paper he wrote down September, 2000 for a presentation he gave in France. I got that from his web site, I think. The consequences of I-131 exposure. Greater than 2000 centigray (cGy) [1 cGy = 1 rad] destroys the thyroid gland. In fact I-131 can be used for -- officially for thyroidectomy.

Susan Kaplan: Convert for me a cGy. Is that a Rad?

Kowetha Davidson: Let's see. I had that figured out. One rad is equal to one cGy?

Jack Hanley: Yes. I believe so.

Susan Kaplan: So 2000 rads.

Jack Hanley: Yes. Like if you had a Grave's disease and they wanted to zap you -

Susan Kaplan: I just still haven't converted in my mind yet.

Kowetha Davidson: I think he used cGy because it is equal to one rad.

Jack Hanley: And cGy is the way the results are presented in the dose reconstruction.

Kowetha Davidson: And less than 100 cGy -- these are the doses in which you get thyroid cancer. But 10 to 30 cGy -- this is the level for epidemiologic detection. Because once you get radiation levels so low then what happens is that with the dose response -- the lower the dose the lower the response and so the greater number of individuals in your whole population you need in order to detect an effect. And basically what they're saying is that with 10 to 20 cGy is about the limit of epidemiologic detection if you're going to do a study in order to find that there is an association. And I can't remember why I put this in parenthesis but this is some of mine, but I think it may have something to do with low doses of radiation because one of the theories is that all doses of iodine 131 are associated with some risk of cancer and because of genetic damages involved. But The National Academy noted that there is disagreement in the scientific community on this issue. Because the thyroid gland is one of those organs in which you can get cancer by means that are not through genetic damage. So, that's not a 100% conclusive-- accepted by everyone in the scientific community. Quite a large number I think, but not all.

Jack Hanley: But the agencies, The EPA typically uses linear non-threshold -- just for regulatory purposes.

Kowetha Davidson: Yes. They use -- well not for everything.

Jack Hanley: Not all the cancers?

Kowetha Davidson: No. Not for all cancers. Now they use the linear or non-linear model. It all depends. Generally for genetic damage they will use the linear method. But there are also some substances -- I know a little more about chemicals than radiation --

Jack Hanley: That's what I'm talking about.

Kowetha Davidson: There are also some substances that may act by both modes in which you can't specifically say is linear and not non-linear or you can't say is not non-linear and linear. So you can apply both modes of action to it. Both will fit. There are some things in which they do.

Jack Hanley: Karl Markiewicz what is ATSDR's policy on that?

Karl Markiewicz: They follow EPA.

Kowetha Davidson: Basically when you have a non-linear mode this is what they call a threshold. That means that there are some doses in which there is no risk of cancer. And generally what you get is that you get tissue damage. It's not genetic damage. You get tissue damage because if you start killing your cells within an organ then what you get is regenerative proliferation. The organs start proliferating to replace the cells so then you get hypoplasia and then from hypoplasia you make it a net and namonet(ph) and then you get carcinoma which would be cancer.

Jack Hanley: Right.

Kowetha Davidson: Okay. These were other points that Owen (Hoffman) made in his presentation. The one was that releases from the Oak Ridge sources, he is saying, would not change the estimates by more than a factor of 3.

Jack Hanley: Is like the other iodine releases?

Kowetha Davidson: Yes. From other sources. Because I think they mentioned thorax and some other sources.

Susan Kaplan: I think it could be up to 6, right?

Kowetha Davidson: He said 3. I'm getting this from the presentation.

Susan Kaplan: I recently went through those numbers and calculated them with him and I think it was the range of 3 to 6 or something. It's in the iodine write up.

LC Manley: You have to consider what are the sources of the iodine other than -

[static on tape]

Jack Hanley: Yes, there is the Thorax, the reactor -- graphite reactor, the Clinton pile ??..

Susan Kaplan: The table I gave you in the handout on I-131 has Owen Hoffman's comments on those (Thorax and graphite reactors and the Clinton pile) releases.

Kowetha Davidson: But the next statement he made, this was in response to a question that was posed to him by Bill Pardue. And he had made the statement that sharpening the pencil is not necessary he said for general conclusion in a community. He said you don't need to dot all the I's and cross the T's. However probability of causation requires sharpening the pencil because small differences could put a person in eligibility range.

And then this next statement, those estimates encompass a range slightly greater than a factor of 10. Effects cancer -- this is in general. He gave the dose calculations for the different areas and the dose estimates encompass, he said, a range slightly greater than a factor of 10. It's like a ten-fold factor(?). If you are in a factor of 10 then you are in a closer -- you are closer in getting to the target. The excess cancer risk -- the thyroid cancer range is from a few chances in ten thousand to one in a thousand. And this is what you see when you go from dose to risk -- how your range of uncertainty increases when you go from one to the other. And the impact of adding NTS dose estimates to Oak Ridge dose estimates on probability of causation he demonstrated this with the estimates because he showed us several locations in the Oak Ridge area. One was Bradbury, Tennessee, and I think Bradbury is believed to have the greatest impact from I-131 releases. And with this table he showed that this would only be a slight impact by adding the NTS dose for that area because the Oak Ridge releases would be dominant there. But in Wartburg, Tennessee, this is an area believed to be of low impact -- I just selected 2. The highest impact and then just one of low impact as examples. And from the Oak Ridge would be greatly impacted by the NTS doses because the Oak Ridge releases from that were relatively small.

LC Manley: Now where is Bradbury, Tennessee?

Kowetha Davidson: I have no idea.

Jack Hanley: Bradbury is right across -- it's actually where Ms. Galloway is from. She grew up there.

Susan Kaplan: The Jones Island area?

Jack Hanley: Yes. It's right across the river.

Susan Kaplan: You know where the dam is? Melton Hill Dam? If you jump off the dam and go down river there is an island just dead ahead. That's Jones Island.

Kowetha Davidson: Oh. ??... [Deb?] showed us that on the -

Susan Kaplan: And she lived right across from Jones Island.

Jack Hanley: Right. Across the river from exit 10.

Kowetha Davidson: Oh we stopped there on a tour. Didn't they stop there because they stopped there and they showed --

Susan Kaplan: ??...

Kowetha Davidson: Okay. It's off on a private road.

Jack Hanley: Yes. So Bradbury. That's where Ms. Galloway was raised.

Susan Kaplan: Buttermilk Road exit?

Jack Hanley: Yes.

Jack Hanley: That's between I-40 and the river. Right across the river from exit 10. So what they're saying is that the adding of NTS in that general area, even for causation wouldn't add much.

Kowetha Davidson: No. Because the Oak Ridge releases would be the dominant releases there. It would add some but -

Susan Kaplan: If you go back to the hand out I gave you there is another table. I think it was table 4 that actually summarizes the percentage impact of Oak Ridge versus NTS.

LC Manley: When you're thinking of Bradbury (TN), that's basically going west of Exit 10. So the impact is basically southwest of the fact -- to me the it looks that people along the interstate, that area, would have been most susceptible to iodine than Bradbury. But Bradbury would be the most susceptible to some of the stuff dumped in White Oak Creek.

Jack Hanley: Yes. If it came out of the creek, correct. It would have gone there. But the iodine stayed in the valley, went up the valley. The winds in the valley go back and forth. So sometimes it went the other way down to Bradbury (TN) and other times it went over to Gallahar Bend which is a little further. And so that's how it was going. Every now and then it would cross the ridges but it was mainly going up and down the ridges. Between the ridges.

Kowetha Davidson: And my conclusion is -- that I got according to this presentation is that adding the NTS dose estimate to the Oak Ridge dose estimate is not necessarily for general conclusions in the community. And that's for public health. And this other little slide here is on different types of causation. There is epidemiologic causation, there are 9 criteria. It's called The Hill's Criteria. I didn't mention all 9 of those that epidemiologists use if they're going to have -- for identifying the causes of diseases that are associated with exposure.

Jack Hanley: I think Lucy (Peipins) covered those when she gave her presentation.

Kowetha Davidson: Yes. And the other -- legal causation -- and this is a probability of causation and is used in litigation, and it supports a finding of more likely than not. That's a greater than 50% attributable risk. And attributable risk is equal to the relative risk minus one divided by the relative risk. This is a little mathematical formula that is used in calculating this.

Jack Hanley: But as far as ATSDR, we do not get into probability of causation that is outside of what we do. We deal more with the epi-causation criteria than the legal one. The legal is for compensation, lawsuits, insurance, liabilities, that type of thing and we deal in the public health arena.

Susan Kaplan: Who makes the call to take the next step? Isn't that going to rest in your hands?

Jack Hanley: What? On the epidemiology causation of the effects of these things?

Susan Kaplan: Yes. Whether to go to the next step of either the epi or the legal?

Jack Hanley: Yes.

Susan Kaplan: You will make that decision?

Jack Hanley: No. We do not go down the legal route.

Kowetha Davidson: That's an individual's -

Jack Hanley: That's an individual filing lawsuits or insurance or liability.

Susan Kaplan: Yes. But if the data is not there than nobody can do anything.
Jack Hanley: Yes. We focus on public health. We do not get into the probability of causation. You know who gets into probability of causation?

END OF SIDE ONE OF AUDIO CASSETTE

SIDE TWO

Karl Markiewicz: When we're talking about estimates compared to calculations the same thing holds true when we're looking at cancer risks and we're looking at the one in 10 thousand or one in 100 thousand, or one in a million -- whatever the number is. 3.65 times ten to the minus 50, there is an exactness that is implied in that number which isn't there because it is an estimate. It is not an actual calculation of risk and I think we as scientists and agencies and everyone, we need to do a better job of explaining that because I know people will grab that number and say, "I know my -- based on your calculation I have a one in 10 thousand risk of getting, whatever." And that's not the case. It may be, but it's just an estimate and it's a calculation of risk.

I'd like to get a copy of the memo so I can --

Kowetha Davidson: I can e-mail it to you.

David Johnson: Oh that would be great.

Susan Kaplan: Would you e-mail it to all of us? I would like a copy of it.

Kowetha Davidson: Okay. Some of this didn't quite come out. Because I went in and fixed this-

Jack Hanley: You may want to put draft and then when we go final-

Kowetha Davidson: Okay. I'll put draft. It won't look like this because we have this nice little copier we send things to that -

Jack Hanley: You have a copier that did this? Puts 4 on a page? That's neat.

Kowetha Davidson: Our computers are hooked up to it.

LC Manley: She's in a high tech department.

Kowetha Davidson: Instead of using our printers we use our copiers.

LC Manley: ??... [Sharpen your nails ??... you do very little.]

Jack Hanley: This is a lot of -- this is just like Susan Kaplan's work. This is a tremendous effort.

Kowetha Davidson: I don't know if I'm going to be able to do all of this in whatever time I'm allotted. Because of whatever other reports we have or work group reports at the meeting. So I'm going to have to through and pare this down some. Because -

Jack Hanley: Let me ask you a couple of things. Do you think you should present this at the June meeting or do you think the work group should discuss this a little bit more and then bring it back? Or what are your thoughts?

Kowetha Davidson: It would be good to have another meeting with more people here to provide input on the recommendations and if you put it off until the next meeting, then we could just have a presentation of this outside of the work group presentations and there would be more time to do it.

Susan Kaplan: That's what I rather do.

Jack Hanley: Some time in August. We're looking at around August 20^th. We're going to confirm that when we have the next meeting. And then possibly October 8^th, I think it was?

Kowetha Davidson: Yes. It was the next meeting.

Jack Hanley: The one after that.

Kowetha Davidson: We'll only have one more meeting this fiscal year.

Jack Hanley: But we'll continue with the work groups.

Susan Kaplan: That would make me happy if you would delay.

Jack Hanley: So would it -

Kowetha Davidson: That would give me more time to do some more reading because Paul has been sending me some more stuff on this. Well I have some because the National Institute of Environmental Health Sciences (NIEHS), I think has had a conference on thyroid cancer. And one of their publications they had quite a few presentations on thyroid cancer and Chernobyl.

Jack Hanley: But Chernobyl, there are always new things coming out.

Kowetha Davidson: And so he's been sending me stuff on this and I haven't had a chance to even pull it off of my e-mail to read yet.

Jack Hanley: Well this is an excellent working draft, I believe.

David Johnson: Absolutely. I'm just ??... [disappointed(?)] that Glenn wasn't here to really participate.

Those presentations -- back last June, those presentations. I was pretty familiar with the issues. When I listened to (Tom) Widner I knew he was covering some really important stuff but it was so much that I knew you all were being overwhelmed. And then Owen (Hoffman) got on and his was a little more concise. But Owen had tremendous information. A lot of good information. Another thing he talked about was the chances of getting thyroids and then once you start to screen -- he talked about the screening programs. Other things besides this. And then -- so there was a lot discussed. And then when Charlie came -- you know we had 9/11. And Charlie did a good job in that. So there is a lot of information in all of those presentations.

Kowetha Davidson: And I only pulled out information related to adding doses. Because there were a lot of things discussed that they discussed that I did not -- because this is all they asked me to do so I did not do any of the other stuff.

Jack Hanley: We wanted you to cover everything. No!

Kowetha Davidson: Are we going to vote on whether to wait or are we going to just make it an executive decision?

Jack Hanley: It's up to you. You all do it.

Kowetha Davidson: We'll make it an executive decision. We'll -- I'll have this ready for the next work group meeting. At the next work group meeting.

Susan Kaplan: The 17^th?

Kowetha Davidson: I hope we're not going to meet on the 17^th.

Jack Hanley: I don't think he's planning -- I don't remember Bob—

Kowetha Davidson: I hope we're not planning on a work group meeting that day.

Jack Hanley: If we do, but they—

Kowetha Davidson: If we do we won't go through this.

Jack Hanley: This is your third time, right?

Kowetha Davidson: Yes.

Jack Hanley: So we could -- you all could have it some time in July or something and just talk about it.

Kowetha Davidson: Or we could have it at the one after that.

Jack Hanley: Yes. Because maybe a good thing is for people to look at this and then come to you with questions. Then you could just answer questions instead of presenting all over again. Unless you thought you could stream it down.

Kowetha Davidson: It all depends on how much time they give me as to whether -- and how much paring down. Because with all that stuff Paul has been sending me it could end up exploding.

David Johnson: Have him summarize it.

Susan Kaplan: Is there any new business or are we done?

Kowetha Davidson: Is there any new business? I'm asking now. Is there any new business? There is no new business then we are adjourned.