ORRHES Meeting Minutes
December 2, 2003

Presentation by Mr. Jack Hanley

(Brief recess.)

MR. HANLEY: I wanted to go over real briefly; this is going to be my presentation. First, I want to go through the public health assessment process real quickly, a quick overview of that; present an overview of the public comments. My presentation is on the public comments. Then ATSDR’s responses to all the public’s comments, EPA, and then the public comments, and then we’re going to present the changes that we made in the public health assessment. Just to recap, in November of last year, 2002, EPA completed its sampling in the Scarboro community. Once we got a hold of that data we started our health assessment on the Y-12 uranium releases and we approached the PHAWG at that meeting and presented the data that we were going to use and discussed the data. We wrote up the health assessment and during that time in December we gave a presentation, informal presentation, on our findings, and by December 31st we had a document out to the PHAWG and the subcommittee. We called it a data validation and initial release. We presented at the PHAWG meeting last January, January 21st and 22nd, the work group worked over the next few months into February to compile the comments. Tony led that effort in compiling them, putting the PHAWG comments, community comments, community members participated, and the comments were sent to the subcommittee and at the March meeting last year a subcommittee submitted their comments to ATSDR. At the same time, the document went out to other agencies and we received comments from Region IV during this time period. Then on April 22nd we came out with a public comment version and we received comments from the public. We also received comments again from Region IV EPA and EPA Headquarters, it’s the Office of Radiation and Indoor Air, and I’ll cover those types of comments in a minute. We had a discussion with the subcommittee and then after forty-five days we got comments from the public at this point, and here we are now we’re coming back to the subcommittee; we’ve already been to the PHAWG, and we’re coming back to the subcommittee discussing the comments, our responses, and any changes that we’ve made in the health assessment. That’s what we’re doing right here. We plan to release the final some time this month, later in the month. Brief overview of the comments, as I said, we actually released the document in April but the formal public comment period started May 5th and went through June 20th. We received comments from thirteen individuals representing at least six organizations and their agencies. ATSDR received and responded to over a hundred and seventy comments, very detailed comments, got detailed responses. Comments that were kind of general; they got a kind of general answer back, because it’s hard to respond to some general comments. We had editorial comments which we did not include in our responses and we looked at the comments that questioned the validity of statements made and we corrected and verified those in the document. What I would like to do at this point is to regarding the EPA comments, before I get into the details of the EPA comments we received a letter yesterday and I’ll pass it out. This letter is from Region IV, the Regional Project Manager from Region IV, yeah, Remedial Project Manager, Jeff Crane. I’d like everybody to take a minute and read the letter; we’ll just take our time here. What I’d like to do is address a couple of the issues in here, in the letter. Paul and I will address a few of these issues. We have questions after that and you can ask Paul or I or we can get clarification from Jon Richards at EPA and work this out. But as you read the first paragraph, get down towards the middle or a little towards the bottom it says; for the comments originating from Region IV, I just want to note that Region IV says we conclude that ATSDR has provided adequate responses. We had worked with Region IV, spoke with them, and discussed the issues that they had, provided response to them via e-mail discussions, they saw the responses, and as far as Region IV’s comments, they say we adequately responded to their comments. The next item, the next sentence says that EPA Region IV noted that some of the ATSDR comments responses to the detailed comments provided by ORIA, that’s the Office of Radiation and Indoor Air, may require further consultation between ATSDR and ORIA. On that particular issue, when we consulted with Region IV when they got the responses, Jon forwarded the responses on to ORIA and the staff up there and when we spoke to Jon after that, Jon Richards at Region IV, he mentioned that ORIA had some concerns and suggested we call them. So, we have an ATSDR staffer in the EPA Headquarters office, he’s a liaison, and so we talked to him and he contacted the management in ORIA. ORIA told him that they were not going to have any further comments. So, that is the status of that issue. Now, based on this last sentence here, we encourage your staff to contact ORIA and address any of these concerns, technical comments. They were not going to forward any comments to us in writing, but they’re mentioning here that they still have concerns; we’re going to approach again ORIA to talk to them and to see if we can address their concerns. I know the committee is concerned about this and Kowetha has written, the Chair has written a letter directly to ORIA and what we would like to do is if we could set up this conference call to discuss these issues we would like to offer Kowetha if she could to sit in and participate in that discussion on these comments and responses to the outstanding issues that ORIA may have. We’ll go down to the last paragraph on the first page and I think I’ll have Paul address this issue. It is the comment where it says: EPA does not agree with dose or risk criteria ATSDR used for assessing potential long term chronic cancer risk. It says i.e., five thousand millirem a year over seventy years. And Dr. Cember just mentioned that that’s not what we used; I don’t know if it’s a typo, Jon; can we get clarification on that? Because it’s really five thousand millirem over seventy years and it says in your letter, not your letter but Jeff’s letter, five thousand millirem a year over seventy years.

MR. JON RICHARDS: Five thousand millirem over seventy years.

MR. HANLEY: So, that’s just a typo there?

MR. RICHARDS: Yeah.

MR. HANLEY: Paul, you don’t want to answer this? We have presented this material a number of times in subcommittee prior to including it in our assessment. Jeff brought up some good points. We went back and looked at these issues, about a year and a half to two years ago, but regarding this comment I’ll let Paul answer this. And I have here, and I’ll pass this out right now, this is a, this front page is a summary of EPA Office of Radiation and Indoor Air; this is their summary of their comments, this first page. Following it we have each summary comment, their specific comment, and ATSDR’s response to these summary comments and it also identifies which specific comments in the whole set that you all received that it responds to. So, what I would suggest is when you look at this Paul is going to discuss, respond to, this issue about the five thousand millirem and he will use response to EPA summary comment number six. So, if you could turn to EPA comment number six that’s where Paul, oh, it’s seven, I’m sorry. I apologize, seven.

DR. CHARP: This is from the comments that part of our comments back to EPA, if I remember right, correct?

MR. HANLEY: Yes.

DR. CHARP: Where we discuss the doses and what these doses mean. We used five thousand millirem over seventy years as a cancer comparison value and that was based on our review of the current literature on cancer induction by exposure to ionizing radiation. To give you some indication of how that compares with other recommendations or so on from international and national organizations both the International Commission of Radiological Protection, that’s the ICRP, and the National Council on Radiation Protection and Measurements, the M is silent, the NCRP recommend that the public be exposed to no more than a hundred millirem a year. That equates over seventy years to seven thousand millirem, which is a little bit more than our five thousand. The EPA clean up level that at one time was a directive from the Office of Solid Waste and Emergency Response was fifteen millirem per year for all pathways. That’s correct, Jon?

MR. RICHARDS: Actually, it’s the entire risk range. That’s just the upper risk range.

DR. CHARP: Ok, the upper risk range of fifteen millirem a year equated to ten to the minus four thereabouts. When you carry that out over seventy years that’s a upper risk range of about a thousand millirem over seventy years. Now, what we calculated for Scarboro in the past was a hundred and fifty-five millirem over seventy years. So, that actually is a little bit lower by about, it’s about eighty-five percent lower than the EPA upper risk range of fifteen millirem a year. Let’s see, some other numbers, ATSDR MRL which was for non-cancer was a hundred millilrem a year, that’s seven thousand millirem. Again, the ICRP guidance, NCRP guidance, and so on. So, we think that our five thousand millirem over seventy years is within the realm of other national and international organizations who say that over seventy years your dose limit should not be in excess essentially of seven thousand millirem. And we’re about ten, twenty percent lower than that. So, we think our five thousand is defensible based on other national exposure recommendations and so on. Now, in a case of risk that’s another, let me go ahead and say something about that, Jack. The number I have here at the bottom I’ve written in by hand is the, are the risk numbers, EPA and the nominal risk for exposure to ionized radiation for cancer is on the order of five in ten thousand chances per rem of exposure per year. I converted this to millirem to keep all the units in order. So, it’s a half a chance in a million for a cancer induction per millirem per year. The United Nations in their scientific committee and the effects of atomic radiation say that that risk can vary as much as being two times higher or maybe two times lower. That’s why I have, instead of being plus/minus two it’s multiplied or divided by two. That’s the NSCR estimate. So, when you take into account the seventy-one millirem per year that is somewhat of an elevated risk of about three hundred fifty-five chances in ten thousand or so per millirem. So, it is a higher risk but the risk to background is somewhere on the order of, I think its one chance in a thousand for background exposure, 1.8 per thousand. So, we think our number is defensible and what I want to show you on this is, again, comparing the past exposure to the folks living around Y-12 based on the Task 6 report. If you take the EPA clean up of fifteen millirem a year, multiply it by seventy years, it takes it up to a thousand and then the green line shows the difference between our hundred and fifty-five estimate being about six times lower than EPA’s. So, whether or not it’s five thousand or a hundred and fifty or so we think we have a strong case to support our five thousand in seventy years. Now, the panel, there is something in there about the panel.

MR. HANLEY: Yes, at the end on the second page there’s a comment that based on your response to comment we understand ATSDR is using an external panel of epidemiologists and radiation experts and are willing to change based on their input. We highly recommend that these experts include representatives from EPA’s Office of Radiation and Indoor Air, the Office of Solid Waste and Emergency Response, and EPA’s Science Advisory Board Subcommittee on Radiation.

DR. CHARP: The panel is ATSDR’s response to concerns raised by community members within the Oak Ridge area. The panel was selected by our administrator, Dr. Henry Falk. He selected three epidemiologists and one radiation person to assist us in this panel. We had, we meaning Jack or myself or Sandy, no one from the Oak Ridge Office or associated with the Oak Ridge project had any input into who would be members of this panel. We did, however, and with Dr. Falk’s approval, get some opinions from two outside experts in the field of radiation epidemiology. One is Dr. Charles Land from the National Cancer Institute who actually e-mailed ATSDR some concerns about our five thousand over seventy years. And another one was Dr. John Boyce who many people could argue that is probably the world’s renowned expert on radio epidemiology. And both these folks supplied input to ATSDR. In taking into account all the comments we received, this is the bottom line of the panel and I could probably talk for another fifteen, twenty minutes just on what the panel said and that’s being generous. They said; our comparison value of five thousand millirem over seventy years is appropriate for the work ATSDR does. In fact, one of the commenters said it’s not that ATSDR’s five thousand is too high; it’s that the MRL is too low. I thought that was interesting. The panel also said that in the case of expressing the results as a matter of dose or risk it doesn’t make any difference how you express your results. The main issue is how you communicate those results to the public. Which way does the public understand? Do they understand risk better or do they understand dose better?

MR. HANLEY: Paul, could I interject here?

DR. CHARP: Yeah.

MR. HANLEY: One of the things that when the panel was there they did mention this about communicating to the public and they suggest that we get out. We explained the effort that we made here with the five thousand millirem, working with the work group, coming to the subcommittee on a number of occasions, Paul talking about this issue, and the level of effort of developing the tools to try to communicate this information at least to this subcommittee. They thought that was appropriate but the question was then how do you get that information out to others. And so that is still do we use the same materials or something else. It’s the outreach to other folks that needs to be possibly worked on with regards to Oak Ridge, but the main issue here was communication. And if you notice with the thermometer-graph, if you put risk numbers or you put dose numbers, it’s just going to show that same perspective where things fall. So, if you have risk or dose their basic thing is it’s not going to make any difference. The main thing is effectively communicating with the public.

DR. CEMBER: I just want to make a comment on communicating to the public. I think using the word risk is the incorrect thing; it’s a technical term that really means a probability of getting something. And I think if we present it to the public we should say our criterion is the chance of getting cancer being less than one in ten thousand or something like that. Don’t use the word probability but the chance of getting something rather than the word risk, because I’ve checked with some friends and the word risk conjures up in their minds an immediate threat to life or limb and it doesn’t matter what the number is; it’s just the word that’s so scary.

MR. HANLEY: And as you mentioned, it’s a theoretical risk; it’s not an actuarial risk.

MR. LEWIS: Are we going to use, I’m going to try to quote Herman, risk type information as defined by him or are we going to stick with dose when we go to the lay public? Is ATSDR willing to consider looking at risk type numbers?

DR. CHARP: We are willing to consider whatever makes our message most understood by the public. What Al Brooks said was that some people would prefer risk, some people would prefer dose. Jeff?

MR. JEFF HILL: To me, and I think that I’m public, I’m not private so I must be. If you tell me that my likelihood is I’ll receive two MR, what does that mean? But if you tell me the likelihood that that same dose is one in one million increased in risk, or whatever term we want to use, that has meaning. The dose doesn’t have meaning to me as the public.

DR. DAVIDSON: I think it’s all dependant on how we explain dose, because people say the public don’t understand dose but dose is an everyday part of public’s life. Ask anybody who takes a drug. They can tell you exactly how many milligrams they’re taking every day of a drugs. If you’re taking Cephalexin, somebody says I’m taking five hundred milligrams. You know, I’m taking a thousand milligrams or I take five hundred. And they do, because you see older people with their medicines, I have seen them in my family. They get those little bottles and they put those things in and they know exactly how much of each one of those things they are taking and they are looking at it based on dose. And so dose is an actual part; it’s how you explain it to people what dose means. Even things like, you know, people read labels on foods. You look at, you know, how many milligrams of sodium I am getting. You know, how many grams of carbohydrates I am getting. You know, all of this is dose. I think this all depends on how you explain it to them. They may not know they’re discussing dose, but what they’re actually doing is they’re discussing dose. I have high blood pressure. If I take in so many milligrams of sodium per day I’m putting myself in trouble, but I have to keep my milligrams of sodium down below this particular level. So, what they are discussing is dose. But you don’t explain it to them that they are talking about dose, but it is, its dose.

MR. HANLEY: Only if you understand what that dose means. If I understand that this has five milligrams of fat and this has ten, yeah, the five is better for me. The milligram doesn’t mean anything.

DR. DAVIDSON: But when you’re talking about doses in relation, if you have a therapeutic dose you can have a dose that’s going to cause you problem, it’s a dose that’s going to be an over dose, because when you talk about over dose I have gotten too much, you know, I have taken too much of this so I have over dosed on it. It’s all explained. If you take such and such amount this is going to happen to you if you take this amount. If you don’t take the amount below that it’s not going to cause you harm. So, that’s what I mean.

MR. HILL: You’re back to risk. You’re saying this volume creates–

DR. DAVIDSON: No, when I’m saying it’s going to cause you harm is that they have evidence that if you have this much it’s going to cause you harm.

MR. HILL: So, you’re back to risk.

DR. DAVIDSON: No, it’s actually an adverse dose because it has been shown to cause harm. That’s what I’m talking about. It’s not whether you’re going to have a one in ten thousand chance of having–

MR. HILL: But you’re an epidemiologist, right?

DR. DAVIDSON: No, I’m a toxicologist and we deal in–

MR. HILL: I’m a millwright; I don’t deal in dose. I deal in risk.

DR. CHARP: The key thing is to put it in perspective; risk or dose. It has to have a comparison.

MR. HILL: Dose is going to have to have a lot more explanation. When I read Frank Munger he’s not going to say the dose. It’s going to be risk and that’s what, when I pick up the paper that’s what I understand. There is a risk associated with this; the risk is one in a million if it’s two MR.

DR. DAVIDSON: But what does that actually tell you? It gives you a number. But what is it, when it really gets down to it, what is it–

MR. HILL: It’s an increase in risk per dose.

DR. DAVIDSON: Is one in a million, is it a real increase in risk?

MR. HILL: Yeah, compared to none, yeah, it sure is.

MR. HANLEY: The key is to put it all in perspective, either risk or dose, and you have to have a baseline to compare it to.

MEMBER: Jack, you’re correct in that you have to have a baseline to compare it to but I think a lot of the baselines that you’ve listed there are suspect. And what people really want to know and what they really understand is it safer for me to live where I am as opposed to LA or Richmond, Virginia. That they understand.

MR. HANLEY: We had that on there with Denver.

MEMBER: But put it in terms of how much safer is it to live in one place as opposed to the other. That is in a sense risk but it’s a different terminology.

MR. HANLEY: Maybe we should move this to a COWG meeting. That should be a COWG issue.

MR. WASHINGTON: I agree with Jeff. What we’ve got to keep remembering as James keeps telling us, we aren’t writing this report for us; we’ve been working with this now for more than two years. We are writing it for the general public and let’s do everything we can to make sure that the general public understands it. He has just given you some great information. You know, he is having trouble understanding it and he’s been on it for two years. In relation to, you know, where you’re taking a pill, yeah, people might know the dose that they’re taking but they really in reality they don’t really have an idea of what they are taking. So, let’s make it as simple as we possibly can and don’t forget what James has kept preaching to us. We won’t be around to explain this if they have questions. Let the literature, let the document explain itself.

MR. BOX: Speaking again from not only experience; is each of the exposures that people are received there’s a percentage of a body burden that they receive. In other words, when I received my exposure they told me how many micrograms I received. This really didn’t mean a whole lot to me. I knew what the limit was but they also told me that I had received three body burdens. This really tells me something about what I had received. Now, for minor exposures you could say this is a tenth of a body burden or one percent of a body burden of this type of exposure. This gets right down to what a person can understand. I think this would be a good thing to really translate these things into, what percent of a body burden. In other words, a body burden would be the first place where you would notice health effects, and you can say you’re only receiving one percent or less or whatever it is for a particular type exposure.

DR. DAVIDSON: I have to announce that we are in our public comment period. As I had mentioned earlier that we would have to take a break and find out if there were any members of the public who would like to address the subcommittee. And if so, you step up forward to the microphone please.

MR. BROOKS: I have some comments, but it would be better to wait until the presentation is finished.

MR. LEWIS: I’ll go back to what Charles was talking about. In my opinion, we don’t ever define our audience. What we do is we have tendency to continue to play with ourselves. We miss the point that there’s a larger audience out there and as Jeff indicated what does Munger say even as it relates to the EPA effort. What did Munger say? Have we, if what you said, does that counter act what Munger said? Because that’s where the key is. The bottom line is if you don’t do a good job in exposure and risk we run the risk of us being forced to hire somebody else to come back in and do it again, and that’s what I’m tired of.

DR. CHARP: Last but not least, for the folks who attended several of the health assessment work groups we had some pretty interesting discussions on whether ATSDR should be using organ doses or whole body doses. These were some interesting discussions and when the panel evaluated our methodology and compared our methodology to the methodology of the international organizations they said that the committed effective dose equivalent, the CEDE that ATSDR used, is appropriate for ATSDR’s public health activities. They also said that if ATSDR were doing epidemiologic studies or if ATSDR were doing probability of causation then the CEDE would not be appropriate. What is appropriate, however, is if you’re looking at specific isotopes that you know affect an organ and it’s beyond a shadow of a doubt then you have to look at that isotope deposition in the organ. Where does that come in at? The thyroid. And which I have said in front of this panel and other folks before is when ATSDR evaluates iodine releases we will look only at the thyroid and not the dose to the other parts of the body. So, in essence, the panel, both the internal panel and the folks outside that, John Boyce and Charles Land, everybody agreed with the approach that we were taking, the dose limits we were using and so on. So, that’s the results of the panel. Any questions on that? If not, I’ll turn it back over to Jack.

MR. HANLEY: Back to the EPA letter, Region IV letter, there’s one other thing I’d like to address before then I’ll just open it up. But this is, on the second page, the second full sentence it says: Although EPA risk assessments and ATSDR public health assessments are not equivalent; EPA believes that ATSDR should be consistent with the Superfund risk range for both chemicals and radiation risk. And to respond to that one I would like to make a few statements here. First, if you look at our response to comment number six, we mention the issue is that ATSDR should be doing risk assessment, ATSDR should be discussing why EPA’s risk range for CERCLA sites should or should not be used, why does ATSDR use the dose criteria. Those general concepts of dose and risk, health assessment, risk assessment, comments were made. In response to this, if you look under the health assessments and risk assessments it says here; as explained in our public health assessments guidance manual, also as explained in the EPA risk assessment guidance for Superfund human health evaluations manual. Also, as it is explained in this citizen’s guide on risk assessment and public health assessment. Basically, all these documents state the very similar thing, and that is that there are deliberate differences between ATSDR health assessment and the EPA risk assessment. In the Superfund legislation, in the CERCLA legislation in 1980, and also in 1986 when they amended the Superfund called SARA, Congress charted EPA; if you look at the legislation is very clear, that EPA is a regulatory and clean up agency. They clean up the sites; they regulate and clean up. ATSDR is a public health agency. It’s very clear. And our approaches are different because each agency has a different purpose and goal in their assessments, and this is clearly outlined in this citizen’s guide and also in the answers and the responses, I have detailed responses to compare the health assessment and the risk assessment. I’d suggest that you read these responses. We talk about the description of both, the purpose and the goals and objectives of both, and it’s very clear; one is to set up for, the risk assessment is a baseline risk assessment. It’s used to estimate theoretical risk numbers to help risk managers to decide what remediation activities should take place. The health assessment is designed to provide environmental and public health agencies and the community with a conclusion about the actual existence or level of public health hazard polls by exposures to chemicals released from the site. And it goes down further for the goals and the objectives. The exposures that are evaluated are different. ATSDR evaluates past, current, and future. We look at realistic exposures, site-specific exposures that are likely to have occurred or did occur. And EPA in the risk assessment focuses on current and future. Their model is appropriate for protection as a prevention model. ATSDR’s is appropriate model that focuses on the medical and the health perspective, public health perspective.

DR. CEMBER: Is it accurate to say that your agency is really looking retrospectively to see whether or not past exposure has done any harm?

MR. HANLEY: In some aspects, yes. We also look at the current.

DR. CEMBER: Yes, well, if it’s done harm you would like to do something about it. In contrast to the EPA, who really uses a much finer measure for hazard because they want to set regulatory standards that would essentially assure that nobody would be hurt.

MR. HANLEY: Correct.

DR. CEMBER: So, they have two different purposes.

MR. HANLEY: Yes, and they look at current, future probabilities, theoretical risk, adverse effects that is defined by the regulatory standards and requirements.

DR. CEMBER: But the purposes of the two agencies are different.

MR. HANLEY: Different, yes.

DR. CEMBER: So, it’s not unexpected to see that they would use different criteria for calculating risk.

MR. RICHARDS: A lot of this comment originated from my discussion with Elmer Aiken before he retired, and other toxicologists, and my understanding for chemical carcinogens you were using, at least in screening, ten to minus six, ten to minus five, ten to minus four values. So, that’s where the comment originated from. And, again, I appreciate your responses, Jack and Paul addressed this before, and other issues, but that’s really where that issue started and it was more generic than specific to this Oak Ridge Y-12 site. So, I’ve raised it to my headquarters and said is there any differences here that should be addressed at a national ATSDR EPA level to ensure that the public is not confused when we say arsenic chemical carcinogen is ten minus five probability incidence of cancer risk can we not say the same thing for gamma radiation from uranium? That’s where the issue came from and my understanding there was point blank from Elmer and other toxicologists in our office and other parts within EPA. Yes, for chemical carcinogens, that means for non adverse acute health effects, we do use EPA numbers, at least as a screening number. They may actually bring the number up higher or whatever they do, but that’s where the comment originated from.

MR. HANLEY: If you remember with Karl when he mentioned the screening process and went through that process and in our guidance in the screening analysis internally the agency can use for carcinogens risk numbers to prioritize which ones to focus on. But when we make a public health decision, is this a health problem or not, we don’t use those risk numbers. We look at each, in our guidance manual it says we use each, we evaluate each contaminant on a case by case site-specific basis, we weigh the evidence, as Bill mentioned earlier, we look at the literature, we look at the medical literature, the toxicological literature, we look at the doses, the site-specific doses, and we make a public health determination. And this issue regarding chemicals we will have at the PHAWG meeting on December 15th we are planning to have Dr. Alan Susten. He is the, what is his formal position? Assistant Director for Science within my division. He’s been in the division for a number of quite a few years. He worked with EPA Region IV to develop this citizen’s guide. He will be coming to the PHAWG meeting to get into that issue of ATSDR using the doses to make public health decisions and EPA’s using risk assessment, and he’ll discuss some of those issues at that meeting. So, we could have that discussion in detail at the PHAWG meeting.

MR. BURT COOPER: I think the point Jon is making though is an initial screen for chemical contaminants we often do use EPA numbers or ten to the minus six risk for chemicals to fall out to see if whether we take them to the next level. I think that was the point you were making and yes, we can do that, we often do use the EPA numbers.

MR. HANLEY: You’re talking about right here in the screening.

MR. COOPER: Yes, for an initial chemical screen in these initial areas.

MR. HANLEY: But when we make the public health evaluation, the final determination, we use a toxicological medical epidemiologic and other scientific evidence. We try to put those exposures and the exposure and the health implications of that exposure into perspective. That is the purpose of the health assessment, and we do it in a qualitative discussion, not you’re above a certain range or below it and then if you have a problem or not we try to put it in a more qualitative format so that would try to put it in perspective.

MR. CRAIG: Jack, are we going to get a copy of that slide?

MR. HANLEY: Which one?

MR. CRAIG: The one that–

MR. HANLEY: Paul?

UNIDENTIFIED SPEAKER: I guess it’s been a controversy for so long.

MS. SUSAN KAPLAN: Jack, I have a comment too. Recently, I read something that I think helps me understand the difference in the EPA numbers and the public health numbers and that’s that the EPA has to, by law, clean up to a level that makes it protective for creatures like wrens and that helped me understand that they are more susceptible than a human would be. So, their number has to be more rigid by regulatory mandates or whatever to a more restrictive level and tell me if my understanding of that is correct, but that kind of clicked a light bulb for me.

MR. HANLEY: That could play a part; the ecology side could play a part. They use the risk assessment in making a determination, they have to consider financial costs, and can this be cost effective, the remedial operation. They have to consider the ecology, the birds and the bees you might want to say; and then the human health side. And part of making those determinations and if you look in their guidance and in the legislation they’re supposed to use the health assessment part of their baseline risk assessment. There’s a line item in there in that risk assessment where the health assessment is supposed to come in and provide some advice, additional advice, on the health effects. So, they’re supposed to consider all those things. But the risk assessment is a tool to help risk managers make a determination about clean up levels, or if the site should be cleaned up or if there is not a problem. They standardized the process so that it can be used across the board in a regulatory manner.

DR. DAVIDSON: I think we should also remember too is that whether you selected ten to the minus four, ten to the minus five, ten to the minus six levels, you know, for risk as acceptable for whatever; this is a policy. You know, I have not come up with a scientific basis for that. It’s what we consider policy. If we clean up to this level then we consider it to be safe for now and in the future. So, it’s policy. I think it’s what EPA calls science policy, if I’m not mistaken. They do have science policy.

MR. HANLEY: I guess, James, you have a question or comment.

MR. LEWIS: I’d like to hear from Jon Richards from EPA. I would prefer for him to explain the role of what their agency does versus ATSDR. I’d just like to hear from him.

MR. RICHARDS: I don’t think he’s said anything we would disagree with. Again, we may disagree on the levels used and again, that’s why I’ve addressed it with headquarters because it’s outside my expertise on chemical risk range, but everything he’s described I have no disagreement with. I never had an issue between, or we didn’t have an issue between ATSDR public health assessments and Superfund risk assessments and sometimes I know my comment got confused and it may have got confused between the two but again, I was just going back to my original discussion with Elmer who retired back in the spring when this came out. And we took a survey of other regions to see if ATSDR had applied this consistent that they had. It was my understanding; again, it was a little bit inconsistent between radiation carcinogens and chemical carcinogens. I know they have a basic disagreement with that and I think our headquarters should address as much as their headquarters. So, we don’t have any confusion with the public. Superfund is looking at risk range thirty or lifetime; they’re obviously looking at a seventy year lifetime. So, that has to be clear when you are looking at making sure you’re comparing apples to apples. And the way Paul put those numbers out that was for seventy years but you just extrapolate it from thirty to seventy. But we’re looking at ten to the minus six, risk screens go to ten to the minus four; that’s approximately equal to fifteen millirem for approximately ten or so radionuclide at a common DOE site. It’s not a one to one ratio; for that approximation we had an officer guidance. That was the guide sites and their clean ups so we don’t just go for the upper end of the risk range to clean up; many sites at Oak Ridge, the one I was on this morning at another meeting, this one time ten minus four cumulative risk for both radiation and chemical risk and from there we back calculated the Pico curies per gram and whatever else they calculated.

MR. HANLEY: James, in response and to add a little more to what Jon is saying, this document, as I said before, was prepared by EPA and ATSDR. Elmer was in the middle of working with this document. Also, you had the State of Alabama, Florida, and Georgia state health departments and agencies were involved also. So, this, I think, is a good comparison; it kind of gives you an outline of what the differences are. Also, as we outlined in our responses, we put very detailed responses, and these responses come, this material comes out of our guidance manual, this document and EPA’s risk assessment human health evaluation manual. So you may want to take a look at this to help you see those differences.

DR. DAVIDSON: Al.

MR. BROOKS: This is what I call my de ja vu all over again speech. On lower East Fork Poplar Creek, 1989, December, it was declared a Superfund site and EPA became active in it. We went through a period of several years where the DOE and the public had one point of view on the levels and EPA had another. We got very unhelpful answers. Namely; it’s the law, we have a regulatory policy. Finally, after a lot of pressure, Elmer Aiken explained that technically the Oak Ridge public was correct, but and then he explained the EPA objectives, policies, and the methods which they operated, which served a great deal to clarify the problem. I do not believe that this difference between EPA and DOE and the Oak Ridge public was ever resolved. We more or less went to the mat on the thing with public meetings and public comments in large numbers, and it seems to me that we’re entering into the same situation here with respect to the Uranium levels. EPA has not responded in any definitive manner; their latest response suggests that they concur in the final conclusions but someone up in Washington has some reservations that need further discussion. I’m not going to go into the details of things but these things seem to center around two things; one is ATSDR doesn’t use the same exact methodology that EPA uses and Jack has addressed this question; there is also the Office of Radiation and Indoor Air made it quite a bit about subjective uncertainty analysis and that question has an answer. Presumably these estimates have been made with conservative values and them certainly then should give more conservative answers than uncertainty analysis would come up with. I don’t think this question that EPA has with large segments of the risk analysis world is going to be resolved here in Oak Ridge and I do not think that the ORRHES forum is an appropriate place. As Jon suggested, this should be discussed at a higher level meeting and on general terms, not in terms of specific requirements of a specific site. Let me just ask you to read what I have written and tell you that I believe that ORRHES has to move ahead based upon the evidence that it has, the discussions that they’ve heard, the remarks that they’ve had from EPA, without waiting for a resolution of the differences between EPA and ATSDR. They need to move ahead and make whatever kind of recommendation they see fit with respect to the uranium analysis. Thank you.

DR. DAVIDSON: Thanks, Al.

MR. RICHARDS: If there is anything else regarding EPA now is the time to speak.

DR. DAVIDSON: I would just like to make a comment. It’s that the way EPA has handled the comments for this document has really caused problems in the community and I would like for EPA to assess, you know, what they’re doing. You know, the comments are fine but not in such a way that they’re going to have a negative impact on this subcommittee as well as the community and I think they should take that to mind because, as far as I know, the people from this office and headquarters have not been to Oak Ridge. If they’re going to put this out they need to come to Oak Ridge and feel the heat and see the people whom they are impacting because otherwise I think they should get their act together and do this in a different way so that it does not have the negative impact that this has had. And this is a great concern to me because we have to move on; we’ve got a lot of things that we have to do but if we have to keep back stepping because of EPA then it’s going to cause just more problems in the future.

MR. RICHARDS: I’ll respond to that. First, I have taken a lot of criticism inside, Jeff Crane and I, and obviously outside and never again will we put out comments separately. That’s not been our practice ever within the Superfund Oak Ridge documents that Jeff Crane is in charge of; this is one case it did happen and I take full responsibility for that; it will never happen again based on my own management, based on this committee. Normally, it would have come out all together through my comments. Second, yes, many of ORIA have been to Oak Ridge like all other DOE sites and just because their comments were critical and I think they were just technical comments in nature that Jack has assured me that they are going to get with them to address and there may be a point where they just agree to disagree, and that’s fine. I think that could have happened months ago. There’s always going to be that even when they’re Oak Ridge, Savannah River, Paducah, Maxi Flats, other documents that we have; sometimes it’s criticism, sometimes we disagree with the method, we don’t disagree with the overall that there’s no apparent public health hazard; I have that in my comments in writing. But that doesn’t mean that we agree with every approach that ATSDR does, and I think a lot of that can be worked out, again, with simple contact between the two of them. And, again, I apologize that these comments came out separate than our Region IV comments and I can assure you that will never happen again or I won’t be working at EPA anymore.

DR. DAVIDSON: Ok, I’m not criticizing the comments; I’m just criticizing the way it was handled, because EPA has a right to make their comments. It was just the way it was handled between the two offices; that was my problem, not the comments themselves, but the way it was handled.

MR. RICHARDS: That all goes back to me because their comments were all, didn’t necessarily originate from me but we often use our headquarters whether it’s from Superfund or radiation expertise to either back up, in this case my three pages compared to their thirty pages. Obviously, they went way beyond what I commented on. That’s not unusual for me to encourage them to comment on the document or from Region 10 Seattle to get help on a Hanford document. Again, unfortunately, I did not put these all under one signature and that’s why you can have the criticism as you have.

MR. LEWIS: We have work groups, we have PHAWG work groups, and I think that this was designed primarily because this is a high involvement site, I would like to know or see EPA and the other liaison members, I know Ms. Vowell comes out and Chudy at times, but if you’re not involved in the work groups where issues are being addressed, and we used to talk to Elmer about this, I think it’s hard to stay abreast of what you’re doing. If we put forth all of this effort here, do they provide you with the time to either call in on the work group meetings to stay familiar with this so you’ll know where we’re going before we get to these types of issues?

MR. RICHARDS: When I was taking over this liaison from Elmer I asked very specifically has he ever been involved in the PHAWG groups and he said no. And I said well, there are a lot of these issues, just what you’re saying, it looked like it would be beneficial to be a part of. So, I’m perfectly willing; I’ve been getting the e-mail since I’ve been on the committee since June. Not all the meetings I can obviously get to but some I can; at least I can get to by conference call; I know they’re usually at night, on Monday night. So, in the future, especially with White Oak Creek coming up and other ones I will do my best to be a part of it. Again, I missed the last meeting; this is very high priority but so far I have not been told this is my highest priority. So, when you have two conflicts and this only comes on one date.

MR. LEWIS: Should that be extended to your friends in Washington?

MR. RICHARD: No, they will not comment unless I ask them in the future.

MR. LEWIS: I mean, as far as listening in on the PHAWG, that’s all I’m saying.

DR. DAVIDSON: Thank you, Jon.

MR. HANLEY: If you could review the summary comments and let me know if there is any particular one that the subcommittee is interested in and we can discuss. There was so many, like Jon said, there was thirty something pages, EPA summarized these basic comments, and if there’s any that the subcommittee wants to go over, if not they can review this material at a later date, but instead of covering each one of these.

MR. RICHARDS: I do have to go, I have an urgent meeting back in Atlanta, but any of these that come up I will be having a conference call with Elizabeth Cotsworth tomorrow, Head of ORIA, at 2:30. So, just let me know any of these that in particular the subcommittee would like addressed or if EPA thinks ATSDR has addressed it adequately or any other issue. And I think you were going to have a conference call with them shortly after.

UNIDENTIFIED SPEAKER: Well, we’re going to put in a call to them. Kowetha sent a letter to Elizabeth Cotsworth. Did they have any comments?

MR. RICHARDS: Yes, it went out the 21st. They did not receive it until the 25th when I received mine. Obviously, that was the Tuesday before Thanksgiving. When I finally got a hold of them yesterday and this morning, again, they’re looking through the comments now to see what issues they still think they need to talk to you about, the detail technical issues. But, again, if there is any the subcommittee had from these; again, this was part of my organizing their comments, getting them to summarize the main points.

DR. DAVIDSON: Are they planning on responding to the letter?

MR. RICHARDS: Yes, but again, you sent it out late Friday the 21st.

DR. DAVIDSON: I’m not saying when, I’m just wondering if they’re planning on responding to the letter some time between now and our next subcommittee meeting.

MR. RICHARDS: Yes, it’s in the letter to respond and they plan to respond.

DR. DAVIDSON: Ok, thank you.

MS. KAPLAN: Jack, could you talk about number three and number eight? I think they kind of go together.

MR. HANLEY: Number three and number eight. Here you go, Kowetha. Number three is that they believe that we underestimated the radiation dose for the inhalation pathway. This is primarily with the past exposure. We used, as I mentioned, the State of Tennessee screening evaluation of Y-12 Uranium releases, also K-25 Uranium releases, but we focused on the Y-12 Uranium releases. And just to give you a little perspective on it, the state had those, that dose reconstruction was conducted under the oversight of the ORHASP panel, that’s the Oak Ridge Health Agreement Steering Panel, they had technical experts and community experts. Also, the state oversaw that operation conducted by Chem Risk. The state then had that study evaluated by a peer reviewers and then ATSDR took the final document and had it technically reviewed by some outside experts. And the reason I’m going through all this is that this document was thoroughly reviewed. Our review, we asked the technical reviewers, there were four of them, we asked them to determine if the Task 6 screening evaluation provides a foundation on which ATSDR can make public health decisions and actions, and particularly it would help us support our public health assessment mandated activities. And our expert panel that reviewed this, they found the report to be technically sound and applicable to decision making, it conformed to established and general accepted techniques, and overall they agreed that the screening assessment is adequate for public health decision making. However, they did note that if there was a need to go beyond screening then you would have to do more, a lot more, with uncertainty analysis, more investigation to do a complete dose reconstruction. And that was their basic finding. What I’d like to do here is I have a summary of what the technical reviewers said, who they were, and it describes their basic function.

MS. KAPLAN: But what does EPA say? What is the difference in what you did and what EPA is saying you should do?

MR. HANLEY: EPA’s comments were that we should go back and do a full dose reconstruction using uncertainty analysis, sensitivity analysis, do more research, evaluate the air, redo the air monitoring, check all that out, and do modeling for dispersion and just do a whole new dose reconstruction.

MR. MALINAUSKAS: Let’s see if I understand this correctly. EPA agrees with the bottom line?

MR. HANLEY: Not for past.

MR. MALINAUSKAS: Not for past.

MR. HANLEY: EPA Headquarters does not agree on the past, conclusions on the past.

MR. MALINAUSKAS: But the letter does not specify whether it’s past or–

MS. KAPLAN: That’s where the whole controversy started.

MR. MALINAUSKAS: Now I am confused. But my impression was that EPA’s position was the bottom line is correct except what you say is a high degree of conservatism is not correct.

MR. HANLEY: Yeah, they do say that; they do make those points. But which EPA? That’s headquarter’s comments. Region IV concluded with the findings.

MR. MALINAUSKAS: But I’m still worried about the bottom line. The people in Scarboro have been told by the Nashville Press that it’s unsafe to live there and does EPA concur with ATSDR’s statement that it’s perfectly safe to live there as anywhere else in the area?

DR. DAVIDSON: EPA doesn’t have that information.

MR. LEWIS: What does the letter say? The letter says on this paragraph right here, this is interesting to me, I think it’s the second paragraph. Read that second paragraph. But what do they link it to? They actually link it to the efforts that ATSDR’s public health assessment confirms the conclusion from EPA’s sampling study of Scarboro area that there are no public health concerns to the community. From their efforts when they went over there to take a look they completed their efforts I think they were looking at the current conditions, help me now, they looked at, right, but they were brought in for the purpose of doing what?

MR. HANLEY: Validating.

MR. LEWIS: And FAMU was there for what purpose? To the best of my knowledge, they were there to look at the current conditions and that’s why I was having problems in reading this. I think that’s what they’re saying. I’m not saying I’m right or wrong. That’s what that says to me.

UNIDENTIFIED SPEAKER: Let me again put it in simple terms. Is EPA saying that in the past it was not safe to live in Scarboro but now it is? That’s in terms that the public would understand.

DR. DAVIDSON: I don’t think EPA has the data to draw that conclusion; they just disagree with what ATSDR has done. They don’t have the data to draw the conclusion from; they just disagree with what ATSDR has done.

UNIDENTIFIED SPEAKER: But there’s a better explanation in the next paragraph that says although EPA agrees with ATSDR that there are no apparent adverse health effects as documented in the subject report EPA does not agree with the dose or risk criteria. And that’s, what they say is there is no effect but we just don’t agree with your criteria for how you, I don’t think they’re arguing with the bottom line.
DR. CHARP: Jack, if I could put my two cents in. Just to throw another monkey wrench into everything, when I reviewed the EPA comments from ORIA my thoughts were that they disagreed with the entire modeling process that was used for the past exposures. Therefore, if they don’t agree that the modeling was done correctly and the Uranium deposition was incorrect therefore the doses are incorrect, and that’s what I think EPA, what that comment says is that because we think the model is wrong, the depositions are wrong, and therefore the doses are wrong. It could be high, it could be low. What they did say is that they think Scarboro is not the sentinel community.

MR. HANLEY: Regarding response to summary comment number three, one of the things EPA suggested is that we modify some of the parameters we use and we should use some of their parameters. What we point out in our response is that the ORHASP and the state and the people doing the work, they worked with the local community members to come up site-specific exposure scenarios, parameters, and that type of thing, not to use the standard EPA default handbook assumptions. But even if you use EPA’s default assumptions, the ones they suggested, they estimated a dose of two hundred and forty-two millirems over seventy years, they did. Ours was one fifty-five. That’s still below our comparison value, and if you take their fifteen millirem and you convert it to seventy years that is still below their guidelines for clean up.

UNIDENTIFIED SPEAKER: So, they agree with the bottom line.
MR. HANLEY: That’s what this letter says now, this letter. You’re asking me about their previous comments or are you talking about this letter? We have not received any written comments from EPA Headquarters, from ORIA, regarding our responses. The only thing I received is this letter and I think Bob clarified it when he read although EPA agrees with ATSDR that there are no apparent adverse health effects as documented in the subject report they disagree with our criteria. So, they say it in there; there’s no apparent health effects.

DR. CEMBER: The criteria they disagree with is the five thousand millirems over seventy years?

MR. HANLEY: Yes.

DR. CEMBER: Did they suggest another one? The criteria?

MR. HANLEY: No.

MR. LEWIS: Does your management team expect another response out of EPA before you issue the document or are you satisfied with what’s there? And maybe, you know, looking over at Sandy, do you plan to go ahead and issue this document based upon what you’ve heard as of this date? Do you plan to change anything that’s associated?

MS. SANDRA ISAACS: We stand by our conclusion that there are no apparent health impacts from Y-12; we stand by that. And though they may disagree with our methodology as we’ve heard from Jon and others. We, at headquarters level, approach things different based on our different mandates and what we’re looking at, and though we may not, we may have approached this differently, we stand by our conclusions and I don’t hear them saying that they disagree with our bottom line, just that the method we used is not what they would have used. But we stand by our document and we do plan to issue our document. We will attempt again to call ORIA and see, you know, we love to settle things when we can but we have different approaches.

MR. LEWIS: How do you manage this in the public’s eye? You know, you can have your position, I guess, and we hear a lot of this, but in my opinion there is a major problem in the community. The lay public who has not been involved in this, you still plan to issue it in its present state or do you plan to do something to ensure that the community, the press, and the lay public understands your position?

MS. ISAACS: I believe that I certainly hope that the COWG will work with us to outreach in a way that helps the community understand the different approaches, but basically, the most important thing is to understand what it means to the people, the exposure.

MR. LEWIS: I’m going to say this and I’m going to be real pointed about it, is it COWG or DHEP? You have a health education group there and we do what we can here but what I’m trying to say is your agency has the responsibility, the way I read your manual, to provide the educational material so people will understand this. If they’re not involved they’re not here then we’re going to create another mess for the community.

MS. ISAACS: I believe there’s probably four, at least three functional units within the agency that have a major role as well as a COWG I think as far as outreach that you all provide, you all can help us shape, but yes, DHEP should be involved in this, the Community Involvement Branch should be involved in this. We have an office, OPO, which includes the public affairs people that also have a role in that. I’m certainly not laying this on the PHAWG because you all can’t, together I hope that we do a good job communicating our bottom line and what it really means to the people.

MR. LEWIS: One other comment is that when you get through looking at your document and as we’ve been talking about health outcome data, and I picked up a copy of your Paducah report, I’ve looked at some of your previous reports where you factored that into it. When you combine all of these things with these what I consider are negatives, they may not be technical negatives to the technical world, but when you start putting these things out in the public and you haven’t dotted your i’s and crossed your t’s to the best of your ability, where does that leave us as a community?

MS. ISAACS: Let me clarify. The conversation moved on so I didn’t go on, but let me clarify what the law says about health outcome data. It lays out the components of a health assessment and I think working with the PHAWG you all have helped us very much, given input into areas that we need to evaluate, but components of the health assessment are we look at the nature and extent of contamination; that’s very much where EPA and DOE and others that have data are involved on that. We look at the demographics of the people, especially the susceptible populations, and very much we’ve got a lot of input from ORRHES, from our work groups about the demographics, susceptible populations, different practices, where people go, not just the self assessment but fishing and things like that that may make people exposed or not exposed. And that goes together for a pathway evaluation. And you heard there that that pathway evaluation, you all, I have had very much input on that to determine whether it is a completed pathway or there’s not a completed pathway. The law goes on to say if there’s a completed pathway you look at the public health implications that are plausible at the dose of exposure. It then goes on to say that if that dose is at a level where there is plausible health outcome data, if our conclusion is that there is no completed pathway, by what the law says, we don’t have to have health outcome data. If there’s a completed pathway and it’s not at a level of health concern we stop, we don’t have to look at health outcome data. If there’s a completed pathway at a level of health concern we look at health outcome that has a plausible link to that exposure dose. So, when Bill said there’s a lot of leeway on whether we look at health outcome data some time if we hear what we very much gather health community health concerns that there’s a perception that they have been exposed at a level of health concerns, we include information about that. It may be more toward health education to help put perspective on like the disease incidents or that sort of thing, but we have to be very careful when we do that. Because if we say there’s not a completed pathway or if there is a completed pathway but it’s not at a level where the tox, the epi, the medical shows that there’s a plausible link, then our discussion has to be real clear that we’re giving information about this disease but that we’re not saying it’s linked. So, we have to be real careful when we discuss a health outcome that does not follow the level, the dose, that we have determined people are being exposed with. So, we have to be real careful about that. And those were two comments I started to say when we were having that but that is what the law says. We look at the health outcome data when there’s a plausible link to the level of exposures that our pathway analysis has determined.

MR. LEWIS: Is your law the guidance manual or is it something else?

MS. ISAACS: That is actually in CERCLA.

MR. HANLEY: I have the guidance right here.

MS. ISAACS: But that comes directly from CERCLA. I’m sure it’s reflected in our guidance manual but the elements of the health assessment, those five key elements of the health assessment, are actually listed in the law. And the key of health outcome data is a plausible link. So, when we for a public health service or to address a concern include health outcome data, as you’ve heard Dee say at the last talk, we have to be real careful about making sure that we’re not saying it’s linked to the exposure. We have to be real careful.

MR. LEWIS: Is that what you did in Paducah? I guess when I looked at some of your reports from Paducah that was included in that report?

MS. ISAACS: Right.

MR. LEWIS: And I guess when I read that, help me now, I guess you clearly stated that there was not a, I don’t think there was a link, so my question is are you going to do something similar here or have you decided as a management team that that doesn’t need to be done here based on the data your evaluation –

MR. HANLEY: I decided that. Let me explain.

MR. LEWIS: I’m asking her. Based upon your review of what has been done by the people who work for you, if you made that call, is that your stance?

MS. ISAACS: I believe that particularly because Y-12 has, the contamination from Y-12 has given segments of the Oak Ridge community such a bad reputation that they didn’t deserve, based on our analysis which we stand by, that we have to be real careful if we get into linking the evaluation of health outcome data and this particular document. I believe that it may be more appropriate, we have a summary document that we’re going to do at the end that looks at all the exposures, I think it would probably be more appropriate to do it later on in the process in our series of health assessment than to put it into the Y-12, to be truthful. So, I very much, Jack has determined that we’re not going to link it in here and I think it’s very wise because you have to be very careful, again, when you do analysis of existing health outcome data in a document that says there is no problem that they understand you’re just giving general information or evaluation to kind of put in perspective the incident in an area versus general occurrences. You just have to be very careful on that.

MR. HANLEY: I’d like to respond to James’ comment because this went on earlier and I didn’t say anything, and this also goes back to Ms. Sonnenburg’s question when I got up and I told her I’d get back to it, so this all will link together. This document does include health outcome data, ok, and I’ll explain that. There’s been a lot of public health activities in the past that have occurred. One of them, I’ll just take for example the Scarboro community health investigation due to the community’s concerns, the state of Tennessee and CDC did an investigation of the children. That was a concern and the agencies responded. This is documented on pages 32 through 37 and it’s very clear what their findings were. Basically, the allegations in the paper were not born out by the investigation. Number two, also in this document there is the State of Tennessee did two statistics reviews which was descriptive epidemiology. Those are summarized in Appendix B. In the original draft we had it in the front of the document. Based on comments from the subcommittee, we moved them to the back; we left them in there. Actually, we were told to take them out but we left them in there. And the state conducted, this is on B7 and B9 in the document, they did a statistics review looking at the cancer incidents but they only had two years of data at that time. This was in 1992. And in 1994 the State of Tennessee conducted, they looked at the mortality rates in the Oak Ridge area for ALS and other MS and other outcomes, mortality, and that is summarized in the health assessment. Also, we summarized in the health assessment in the early 1990's there were some clinical laboratory analysis that was provided to ATSDR, there were medical clinical evaluations that were provided to ATSDR, based on comments and concerns raised by a physician. The findings are summarized on page B3 and B4. All that analysis and discussion is in the document. Basically, we didn’t find any, the case series, the documents that were provided was not sufficient to show any low levels of metals associated with the diseases. And then the State of Tennessee also reviewed the same material and came to the same conclusions. Now, that’s historical; all that material is in the health assessment; it is in the appendices. Now, the other issue is the criteria that James is talking about in our health assessment and in the latest version it’s actually called the final draft; it’s still draft; it’s in the final draft. This is the basic guidance that we have. We have to answer these types of questions in our health assessment. As Sandy said, it says losses; we have to consider an evaluation of mortality and morbidity data in all public health assessments. An assessment should include relevant health outcome data analysis when exposure to the site contaminants may have resulted in the development of health effects. So, here’s the criteria: complete an exposure pathway. Here at Y-12, yes, we have that. We identified that. The timeline of exposure; we’ve identified that. Can we quantify the exposed population? The answer is we think for maybe the Scarboro community and some other areas we may be able to come up with some rough quantitative numbers of how many people were exposed. Sufficient exposure level or latency. Latency we have; sufficient exposure levels, no, we do not have. Follow no, no health outcome data. The guidance says, James, that it’s an analysis of site-related health outcome data is not scientifically reasonable unless the quantitative estimates of exposure show that there could be an outcome. It says no further analysis is appropriate.

MR. LEWIS: On what population are you getting your latency data?

MR. HANLEY: The latency would have been the years of exposure that we’ve determined where we have estimates of exposure during the 40's, 50's, 60's, 70's, 80's, and 90's. We have estimates of exposure for all those years by year, those years.

DR. DAVIDSON: I would just like to say is that we are involved in a cancer statistics review. Did I get that right, Pete? And I was going to say, this will provide health outcome data. That is not ready yet and this information will be incorporated and, as Sandy said, I think it would be more appropriate in a summary document because we have other types of contaminants that could be potentially of interest for that particular data and to put it in just one and I think it would probably be misleading. And we are in the midst of this and I think, you know, we should go on and let this study be completed, get the results so we can discuss it and go on.

MR. HANLEY: I’d like to cover a couple more of these, Kowetha, real quick.

MS. SONNENBURG: Put it in a drawer? What did you say?

DR. DAVIDSON: No, a summary document because the Y-12 Uranium may not be the only contaminant of concern that may be of interest for that data, and it would be best to put it into a summary document. Because we have other contaminants. We are in the midst of this; I think we should go on and complete it, you know, the information will be included in our public health assessment and there is no reason for us to keep going on and on and on and on about this one particular thing. It will be included but there is no reason to put it in each one of these to repeat this over and over again for each one of our public heatlh assessments by each contaminant.

MR. LEWIS: I just have a point. I don’t disagree with you; my point is that when you form a conclusion without evaluating that and you make your final call I personally believe you put yourself at risk. That is the real issue that’s on my plate.

MR. HANLEY: We did evaluate it. We did evaluate it.

MR. LEWIS: You haven’t got the information back from Dee so how can you evaluate it? If you have, then share it with us. That’s all I’m asking.

MR. HANLEY: Well, we evaluated this criteria and that’s what I was going through to show you the criteria and I’m not quite finished here. I said the exposure levels were not high enough; the latency, we believe, was long enough; the geographic area we could identify. The question, so we have a no here on the level, but also here we have health outcome data available for outcome of interests. What is the health outcome of interests for Uranium? Kidney disease, nephrology toxicity, but there’s not a database out there that we can use in the geographic area on kidney toxicity. So, what health outcome should we look for?

MR. LEWIS: All I have to say to you is this and this is, I will agree with that, my point of reference has to do with what Charles and I talked about as we relate to this effort. We wind up in the community defending issues and I think if you can focus on the community for an instant all they know is cancer, and what I keep asking is if you can show that and then reflect that you don’t have information on that, state that to them before you make the call, it makes your document, in my opinion, a lot stronger. That’s all I’m trying to say. I’m not trying to get you to redo the things that you’re doing. What I’m trying to get you to say it is important that the lay public be aware of what’s there and what’s out there. I did not read that in the document that you gave me. When I looked at the document from Paducah it was different and what I’m asking is that type of summary that you’re talking about, if it was placed in that document, with those types of explanations, I basically wouldn’t have an issue.

MR. HANLEY: Well, I have on my slide I’ll show you the changes we’re making in the health assessment based on the comments we received from the public.

MR. LEWIS: Well, I haven’t seen it so how do we know?

MR. HANLEY: I’m not saying that; I’m just saying I’ve not finished my presentation. What we’re going to do is present a health outcome data section and explain this right here, explain this criteria, which ones we meet, which ones we don’t meet. In addition, one of the things the guidance does say, James, and you picked up on this earlier, and that is that if there is a high enough concern for a specific outcome and stuff and there’s a database available to go look at it and track it down and there’s high enough concern and the subcommittee would say go out and look at this because it’s a concern, even though we don’t have an exposure and we don’t anticipate exposure, if that’s what they want, then we will do it. And that’s the same thing with your cancer incidence review. A subcommittee has come to that determination through the ad hoc group which we went over all these issues last year, same types of criteria; we discussed all this in the ad hoc group. We brought all this to the PHAWG and this whole discussion came to the subcommittee in April and then also in August you all recommended a cancer incidence review and we’re going to work on that. So, that will be stated in the document that based on the recommendation of the subcommittee we’re going to do a cancer incidence review. So, we’re going to talk about this criteria, we’re doing a cancer incidence review, plus we have the summary of all the other previous activities that were out there in the past and their basic conclusions, they’re all summarized. So, if I can get to my last slide.

DR. DAVIDSON: Did you want to speak? Herman has had his plaques up for about half an hour.

DR. CEMBER: I just wanted to make a comment in the context of what you’re just saying. I think that Mr. T.C. Mitz, who is otherwise known as the common man in the street, really isn’t interested in all these details and the methods of analyses and so on. He only wants to know is it safe or is it not safe, have I been hurt or have I not been hurt. And although the thing that frightened me most about this is it says here; although the EPA agrees that there was no apparent, etc., the EPA does not agree with the dose or risk criteria, and I think it’s utterly completely essential that all the differences between the ATSDR and the EPA be reconciled because if the common man in the street sees that two government agencies, each one of which has scientists on it are disagreeing with something, that’s what will be caught here and that’s what the newspaper reporter will write about. We have to have something that the common man in the street can understand and he can’t understand disagreement among agencies and he can understand agreement. And as long as there’s any disagreement at all no matter, even if the conclusions are the same, it’s how did we arrive at those conclusions then that will lead to confusion and popular–

MR. HANLEY: If you could turn it around to the advantage and that’s what I did in one of the responses. You have two different agencies, two different approaches, two different methodologies, two different goals and purposes; you ended up in the same spot.

DR. CEMBER: That’s right, but this letter says the EPA does not agree with the dose or risk criteria and that’s what the newspaper reporter will write about and that’s what you will see in headlines, disagreement between EPA and ATSDR.

MR. MALMQUIST: Perception is very important and, as Tony said, the bottom line. We have an eight hundred pound gorilla, CDC, who says it may be wrong and nobody knows who you are, nobody knows who ATSDR is. CDC, yes, but perception of the public says EPA says we’re wrong and it doesn’t matter after that. You’ve got to change it. As Herman says, you either have to get rid of that part in the letter or we’re in trouble.

MS. KAREN GALLOWAY: Did I understand you to say that before any health effect can be considered tied to a contaminant that there has to be a database, there has to be a registry on that particular health effect before it can be considered?

MR. HANLEY: For a descriptive epidemiology, a simple health outcome data analysis which we’re doing, we call it a simple, it’s called descriptive epidemiology. You can’t prove anything either way; it just tells you the situation of what you are and how you compare to the state. That’s what we’re doing with the cancer work. In those situations, that’s what you use, you use a database. However, if we found where the exposures were high enough and we thought there was a health effect they would come in and do analytical epidemiology where it would take a tremendous effort but they can still go ahead and do it, but the dose would have to be high enough to show that there would be an effect. But, yes, we could do studies, even though there’s not a database. They can go out, and if need be, they go door to door, they go get individual exposures, individual outcomes, and they evaluate that data. That can be done, yes, but the dose has to be high enough to consider something like that.

MS. GALLOWAY: There’s a registry on cancer. There’s a registry on birth defects. Is that correct?

MR. HANLEY: The birth defects registry is, I don’t know if it’s quite usable, but, yes, there is one in the state that they’ve been developing in the 1990's.

MS. GALLOWAY: Any others?

MR. HANLEY: There is your death certificates, mortality data, but we discussed in the ad hoc group and in the PHAWG and they recommended to the subcommittee and we discussed this previously, I think Dee touched on this before, is that cancer incidence data is much better data than the death certificate data because you can have misclassification and other problems. So, that’s why we’re focusing on cancer incidence because it’s an actual count; they knew exactly what cancer it is; it’s very specific, and the data has quality assurance and quality controls on it. So, it’s very accurate data, the cancer incidence data.

MS. GALLOWAY: It sounds like realistically it can only be one basically.

MR. HANLEY: And that’s the one we’re doing. Now, if we found high enough levels where there’s a concern then we can come in, hypothetically, make sure it’s hypothetically, if they found extreme levels of uranium in Scarboro, and they could define it and all that and they can do tests, biological tests, to test kidney function and all kind of stuff and they could come in and do all kind of studies, that’s hypothetical. They could do that.

MS. GALLOWAY: But you would expect your higher doses would have happened in the past, I’m not just talking uranium, just any PHA that you’re going to look at. Your end result that you have enough data to really back anything up would be cancer, right? You have a cancer registry that you could deal with; chances are you would not find doses high enough in the past, you know, to go do this big epidemiology.

MR. HANLEY: The cancer incidence review is, after we went through this with the group, is right now the best alternative until we find an exposure that would initiate any other further study. So, right now the cancer incidence review is the one that we are working on and we are moving forward on until we get an exposure that indicates there is something else we should go and track down.

MS. GALLOWAY: Thank you.

MR. HANLEY: Do you have any thoughts on comments on the cancer incidence review and what we’re doing in this discussion and the criteria that we discussed?

MR. MALMQUIST: First of all, I’ll update you; the request has gone into the state prior to Thanksgiving. I tried to get a hold of Dee today and she said she would let me know when we had a response back from them about getting the data and I have not heard from her. As far as the other databases, and I talked to Brenda Vowell and I got her to send me a copy of the reportable diseases, and it wasn’t very clear so I couldn’t reproduce it, but mainly what these are is infectious diseases. You have to report, as a physician, influenza, STD’s; that type of information is reported to the state. The basis is not very good anyway, so when you start looking at things like thyroid disease it doesn’t have to be reported. The incidental things like oh, there’s a lot of thyroid disease, we don’t know. The same thing with kidney disease; it does not have to be reported, so there is no database on most of those things that people would like to get. Then you get the problem we want to go and investigate it. Now, you’re talking about patient confidentiality. And it is since HEPA went into effect, and that’s the new thing when you get your drugs at the drug store you have to sign something, you can’t give out anything. As my pharmacist said, if I go in and ask for my wife’s medicine, he is not supposed to give it to me unless she calls. So, we’ve got a whole other level of bureaucracy on top of us now that we will never get that type of information out. So, yes, the cancer stuff is the best thing we can have. Hopefully, we will be able to find it by county and this geographic area and that’s the best we have right now and we aren’t going to find the other stuff out.
MR. BROOKS: I’d like to speak to the point again on reconciliation with EPA. I agree with Tony these statements are not clear. EPA has had a history in Oak Ridge of delivering not very clear statements and when it came up to the end of the EPA sampling at Scarboro some of us attended a meeting with EPA and we had put pressure on them to make definitive statements, and we went to that meeting with two letters. One, giving them hell because they didn’t make clear statements, and the other congratulating them for making clear statements. And after receiving undeniable statements, that they would make clear statements I tore up one letter and read the other. But don’t believe, oh, yes, that’s the only place we’ve ever had clear statements out of EPA, that this community is not dangerous. What you received is typical EPA of yesteryear, the vague statement half agreeing, half disagreeing. Can it get any worse? Believe me, it can get worse. On Lower East Fork Poplar Creek we had a rod, which after ATSDR had done its thing and declared it safe, they declared the land as being accessible without any restrictions. The first RER that came out that EPA got a hold of they change it, now they changed a legally binding document, to read that the land was conditionally accessible, including my farm. That gives you an idea of what EPA and its confusion can do. You may go through a period where you got less agreement than you have now if you pursue this, so again, by the way, we stopped that one. And the people that did it aren’t at EPA anymore either. I think if you pursue this question with EPA you’re going to have severe delays. I think Kowetha said it very well and I would like to reinforce that; this community needs to move ahead and you’ll just have to make your best judgment on what you’ve got, because God only knows when you’ll get anything any better.

DR. DAVIDSON: Thanks, Al. And on that why don’t we take a fifteen minute break. I think everybody here could use a break and then Jack will finish up when we come back.

(Recess)

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