ORRHES Meeting Minutes
December 2, 2003
Presentation by Dr. William Taylor
DR. WILLIAM TAYLOR: Good afternoon. Can you hear? Good. The focus of today’s meeting is primarily on the Y-12 Uranium Releases Public Health Assessment and you all will be hearing a lot more about that. I’m going to give you a very brief introduction to conclusion categories of public health assessments. The reason for this talk is that you have before you today resolutions to consider on concurring with the conclusions of the public health assessment, the Y-12 assessment. My talk is more generic and I want to give you a little background so you understand what that means, what the conclusions are. And as a little background I will tell you that when the agency first started doing health assessments in the 1980's there was a lot of variety in those reports and it became very clear to the staff that worked at that time that they needed to standardize what they were doing. And as a part of that process quite a few people got together and put out this text which is Public Health Assessment Guidance Manual. This was released and final in 1992 and it’s really quite a remarkable document. It not only takes you through the steps of conducting a health assessment but also there’s a lot of information to draw on that helps the health assessors to complete that job. After close to ten years of using this document the agency staff and others who were using it realized that there was room for improvement and some updating and so, in the late 1990's they began updating it and right now there is a newer version of it that is not yet final. But what is final is that the agency has adopted the conclusion categories from the revised version of the guidance manual, and that’s what I’m going to be talking from today is the newer version; the one that’s in use in the agency. So, whereas the updated Public Health Assessment Guidance Manual is not yet final the conclusion categories are. I have about eleven slides. I’m going to go through some of them very rapidly. I just want to point out some things to you and I’m going to try to keep this talk fairly short. I’m going to be talking about conclusions, recommendations, and the public health action plan, but I’m generally going to concentrate on conclusions. Oh, you have a handout in front of you with most of my slides on it by the way, and you can follow along. There’s one that’s out of order from the selection but it’s the set with the lines on it if you want to take notes. That’s just the way it was printed. Public health assessment conclusions are intended to characterize the degree of public health hazard at a site based on these three principle bullets here. The existence of past, current, or potential future exposures to site-specific contaminants including radionuclides or physical or safety hazards. Secondly, the susceptibility of the potentially exposed population; and finally, the likelihood of exposures resulting in adverse health effects. That’s what the conclusions are about. There are three conclusions and five conclusion categories. Basically, the conclusions are that the conditions pose a hazard, do not pose a hazard, or pose an unknown hazard. The five conclusion categories are listed here.
DR. HERMAN CEMBER: Where it says: pose an unknown hazard. Does that mean
that there is a hazard but you don’t know what it is or is it that
you don’t know whether or not a hazard exists?
DR. TAYLOR: It means that we do not know whether a hazard exists. Good question, thanks. The five conclusion categories are as listed. You can read them. Urgent, public health hazard, public health hazard indeterminate, no apparent, and no public health hazard. Now, when I write conditions up here at the top I might be referring to a particular contaminant of concern, a particular pathway such as breathing air or drinking water. I may be referring to the site as a whole or I may be referring to past, present, or future exposures. The specific meaning is framed by the particular public health assessment and we usually, sometimes there are different choices that we can make as public health assessors. We pick a frame work that works best for the particular instance that we’re talking about and Jack and Paul will tell you more about the frame work for the Y-12 public health assessment. So, conditions can have different meanings depending on the specific document. This is an overhead right out of the guidance manual and it shows you the relationship between three conclusions and five categories. And this is a graphic way of presenting it. The Categories 1 and 2 fall under the hazard and Categories 4 and 5 under no hazard. I think it’s pretty obvious. I think the point I’m making here is that the public health assessor does not make up the language for the conclusion. The language is selected out of the guidance manual and we use those terms and those categories. This is the menu that we choose from when we make our decision.
MR. WASHINGTON: What’s the difference between no apparent public health hazard and no public health hazard?
DR. TAYLOR: That’s a good question. My next slide is on the definitions of the categories so I will address that. You may not have this in your handouts. Ok, you’ve got it, good. ‘No apparent’ applies to sites where exposure might have occurred in the past or is still occurring but the exposures are not at levels likely to cause adverse health effects. With ‘no public health hazard’ Category 5 applies to sites where no exposure exists. So, with number four exposures may have or probably do exists, but the levels of exposure are not likely to cause adverse health effects. And in number five no exposures as best as we can tell. The difference between Categories 1 and 2 is a difference between timing. Number 1, urgent public health hazard, applies to sites that have certain public physical hazards or evidence of short-term, less than one year site- related exposures, which could result in adverse health effects and require quick intervention to stop people from being exposed. With our second category, public health hazard, applies to sites that have certain physical hazards or evidence of chronic more than one year site-related exposures that could result in adverse health effects. And finally, the indeterminate public health hazard is where critical information is lacking, missing, or have not yet been gathered to support a judgment. So, this is the menu and these are the definitions that we’re working from and this will be the foundation for our discussions later today when we talk about the Y-12 Uranium releases. What does it mean to select a category? This is wording I’ve taken out of the guidance manual: It means to arrive at an answer to the question based on available exposure data, toxicological data, epidemiologic data, medical data, and site-specific health outcome data. Are adverse health effects expected in the community including impacts to any uniquely vulnerable populations. For example, children and the elderly in the community.
MR. LEWIS: I guess you’ve got a listing of all sorts of data there. Are we expected to have an evaluation of all quote available date in those areas if it is considered legitimate or validated prior to selecting a category?
DR. TAYLOR: Yes.
MR. BOB CRAIG: James said ‘are we to’, and in fact we are not to, ATSDR is. We advise ATSDR but they make the conclusion.
DR. TAYLOR: That’s true. The health assessor and the agency that puts out the document, that is us.
MR. LEWIS: And if for any reason they don’t utilize some of that should we expect an explanation that’s laid out in the body of the document that clarifies why that is not being used or what the expectations are around that issue?
DR. TAYLOR: I think the answer is not necessarily. It’s up to the health assessor to do that evaluation and determine what data are pertinent.
MR. WASHINGTON: Do you really have a lot of data for the toxicological data on the various contaminants?
DR. TAYLOR: I think it varies quite a bit. We usually have some and over the period of years, the last few decades, we’ve accumulated quite a lot for different contaminants. This is not only at a single site. This would be animal studies and human studies when those studies are available.
MR. WASHINGTON: What about the combination of the contaminants?
DR. TAYLOR: That’s a difficult issue, but it’s one that’s been taken up by the EPA, as well as other organizations for, I would say, a good ten years and there’s research going on in that area. So, there is some information that’s available.
MR. WASHINGTON: Of those that are listed, which one would you say is most credible?
DR. TAYLOR: Credible in what sense?
MR. WASHINGTON: Which one has the most reliability and therefore validity?
DR. TAYLOR: Well, the data are, let me hold that question please and I think I’ll answer it or attempt to address it in a moment, and if I don’t let me know. Yes?
MS. BARBARA SONNENBURG: How would you define health outcome data? Give examples.
DR. TAYLOR: These are, for example, cancer incidents data are health outcome data. These are the data that the state is collecting and is in a registry. Those are public data or data on populations that are available about people’s health.
MS. SONNENBURG: How about children and maybe some kind of educational defects? Would that be health outcome data?
DR. TAYLOR: If it’s available.
MS. SONNENBURG: And if it can be compared?
MR. TAYLOR: Yes. So, for example, somebody’s private medical records are not health outcome data for our purposes because we don’t have access to that. But if it’s collected in a manner that we can examine then it’s health outcome data. CDC, for example, keeps databases on mortality all around the country, all across the country. So, those are health outcome data as well. If there are particular health studies that look at the health of a particular community those might be available; those could be health outcome data.
MR. WASHINGTON: What about the uncorroborated data we got on iodine when we had a meeting some five or six months ago? There were about four or five individuals who came to that meeting and said that they had had that problem and they at least said to us that there were more people in Oak Ridge that had a similar problem?
DR. TAYLOR: I would say the health assessors take into account anecdotal data, which is how I would describe what you’re saying, and there’s not any particular kind of analysis we can do with that, but it’s taken into consideration.
MR. WASHINGTON: But we didn’t do a follow up, right, with those individuals?
DR. TAYLOR: I’m not aware of what we did.
MR. WASHINGTON: Does anybody else remember that? What we did at that meeting? Does anybody else remember the meeting where we had about four or five different individuals who at the time when we were discussing the iodine data came to us and said that many of their classmate had had problems? Did we ever do a follow up on that? Does anybody else on the Board remember that?
MS. PEGGY ADKINS: I remember one person in particular coming and saying that at Kingston the Kinser Drug or Kingston Drug had a very unusual amount of thyroid medication that they issued every month that it was totally out of balance with what other drug stores they compared themselves to administer.
MR. JACK HANLEY: Those concerns were likely to have been captured, and we can validate that, but I’m sure they were captured into the community concerns of database we have. And if it’s an iodine or thyroid issue in discussion that will likely be discussed in the iodine public health assessment and we would hold off that discussion until we get to the iodine where that becomes, where thyroid becomes an issue.
DR. DAVIDSON: I have a question on the relationship of the health outcome data and I guess in the other data too, when it comes to categories in which there’s no exposure. So, if the health outcome data is this data related to the particular contaminant that’s being studied or is this just kind of a general thing? For instance, cancer outcome data would not be related to chemicals that are not carcinogens that have not shown to be carcinogens in either human or animal studies? Would that type of data be discussed for those particular contaminants or would you focus on it for contaminants in which you have said there’s no exposure? Because if there’s no exposure then there shouldn’t be any health outcome related to that particular contaminant.
DR. TAYLOR: I have a couple answers to that. One is that it might depend in part on how strong the exposure assessment is. If our data for our exposure assessment is very strong there may be little need for a discussion of health outcome data. If the exposure assessment indicates that there were not exposures at levels of health concern. On the other the hand, health outcome data still could be included and still could be discussed if there is a strong enough interest in that based on concerns in the community. So, all of these things have to be considered by the team in Atlanta by the health assessors in deciding what’s appropriate to have in the document.
MR. DON BOX: I have a question on Category 3 here that you might clarify for me. In our lives everything seems to be tightening down more and more all the time. If you have a Category 3 and it’s judged as really not a hazard and then new regs come out making it a hazard, do you grandfather this Category 3 or do you go back and reassess everything on it? Category 4, actually.
DR. TAYLOR: Category 4?
MR. BOX: Yes. Where it says–
DR. TAYLOR: We do not re-evaluate our public health assessments unless there is significant and compelling reason to do that, and it may be because new toxicological data appear that are overwhelming and suggest to us that we were not safe enough or we were overly protective. But it depends on the quality of the information that become available and not regulations.
DR. CEMBER: I have a comment with regard to the items for which there’s no exposure but a possible health outcome. If people are concerned and they’re worried about it, we know, everybody knows, all the scientists and I think most people know there’s a strong relationship between body and mind. And if people are fearful about it and we do know there’s real data that show it influences the immune system, for example. So, if people are concerned about the possibility, if some rumor spreads around that there’s contaminant A in there and there really isn’t any or at least you haven’t been able to find it but people are very much concerned about it, this might lead to some mental effects. Does the agency consider mental effects as a medical outcome or a health outcome?
DR. TAYLOR: I don’t know the answer to that. I think, I’m not aware that that has occurred although it might have. One problem may be that mental effects are something that aren’t collected in databases as much.
DR. CEMBER: The mental attitude of the concern have physiological effects; that’s what I was thinking of, and there is a relationship.
DR. PAUL CHARP: In response to Dr. Cember’s question, in some of the assessments I have done on radiological issues where the category was Category 1, an urgent public health concern, we’ve taken into account the psychological effects that people have being exposed to high levels of radiation. So, that’s not the direct answer to your question but we have evaluated that and I’ve told people that they should either see a physician or be evaluated for some type of psychiatric or whatever. So, it has been thought about for the radiation sites and there has actually been quite a few discussions within CDC and ATSDR dealing with weapons of mass destruction; the psychological impacts.
DR. TAYLOR: Are there more questions here?
MR. WASHINGTON: You said that you had told some people if they thought they had some problem with this that they ought to see, what did you say, a psychiatrist?
DR. CHARP: Well, they should seek medical help. We can’t tell people they need to go see a psychiatrist.
MR. WASHINGTON: And this is actually in the database, the statements that you’re making are really a part of–
DR. CHARP: They will be somewhere within the ATSDR record of activity for that site. It wouldn’t necessarily be for Oak Ridge but we’ve had five sites across the country that were contaminated with radioactive material that we considered sufficient hazard where we told EPA put these on the national priority list, and that’s the ones they’ve been evaluated for.
MS. KAPLAN: I don’t think that exactly addressed the question that Herman asked though because, no, it did not. Because he was commenting about the psychological impact on the physical body that results in tangible physical problems, not to go see a shrink because you’re crazy. You know, that was kind of the implication I got there but he’s talking about actual physical effects because your immune system goes down because you’re worried all the time.
DR. CHARP: Well, I know, and I skirted the issue and I said this didn’t answer his question exactly but it was, I knew the question he was asking and, have we ever evaluated that way, no. But we have suggested people go seek medical help if they need it.
DR. TAYLOR: Probably the answer is no we’ve not looked at physical effects as a result of stress or concerns and fear.
MS. ADKINS: Since this has been brought up I just want to clarify for the record that in the fifties and sixties it was just the opposite; everyone was assured unquestionably that there was no harm, that everything was safe, and everybody felt that everything was safe and that it was a joke to think otherwise. That was until they died from cancer and all these other diseases. So, I want to counteract, I just want that to be on the record that scientists would come to the classrooms and in just general conversation it was laughable that there was any possibility that there was harm from the plants.
MR. LEWIS: I want to get back to the statement I heard Kowetha made and correct me if I’m wrong. Kowetha indicated if there was no exposure, you know whether or not you would have to use the health outcome data as a part of your evaluation. I listened to that very closely because I guess when we get to the place there has been some exposure, whether it’s enough to create a hazard is something different. But along with what Herman is saying, we’re talking about the community at large. The community at large has a quote perception, they lack the same technical knowledge that some of the experts in this room have, and they have a deep-seated feeling which was brought out via a good assessment of what the community’s concerns were which is what we did not have, which indicated that cancer was the number one issue. And as a part of that effort I’m sort of silly enough to always read not only your current manual but your old manual, and when I compare those two when you go like from one rev to another you always compare the sections to see what happens. A lot of times you can de-emphasize something. You go from over here where you have a category that says you will address health outcome data. You come over here and it’s a little vague. But if you read deep enough into the body of the text it says there shall be a discussion in that area. I guess the point I’m getting at is that because cancer was such a high item and if it falls under the area of quote health outcome data, is it standard practice when you get information of this nature that that is always taken into account and evaluated as it relates to the health of the, the mental health of the public who is very concerned about something over thirty or forty years. Do you weigh that in as part of the evidence that determines whether or not to address that as a part of your health assessment?
DR. TAYLOR: I think the answer is yes. I want to return to that issue and Mr. Washington’s question and some comments that various people have raised in this overhead. I’m not going to read these. The title here is what factor influence the selection of a conclusion category and you see here at the bottom, I’m going to move this up so you can see it. Community health concern and community specific health outcome data are part of that, and what I want to say to you again is that the health assessor has to determine where is the most compelling information and we call it a weight of evidence approach in the new guidance manual and it’s a subjective professional opinion. So, there’s not one answer for every public health assessment. The data have to be looked at for how good they are and how adequate they are, data of all different kinds. So, I hope that helps you understand. Many times, I would say most of the time, the conclusion falls out pretty easily, usually from the exposure assessment and evaluation. Sometimes it’s not so clear but the health assessor is compelled by the guidance manual and the way we’ve been doing things over the course of the agency to take into consideration all of the available information.
DR. CEMBER: I don’t see in there a category on the magnitude of the exposure. We talked about the exposures there, potential and actual, but I’m sure you do consider the magnitude of the exposure, but it’s not listed explicitly in there.
DR. TAYLOR: Yeah, when I hear the term exposure assessment myself I think it actually can mean a couple of things. It can mean a pathways assessment of whether or not there were exposures. And secondly, if there were exposures, what were the magnitudes and what are the health implications of those. So, you look at the exposures and ATSDR puts its exposures in terms of doses. So, that’s our unit of measure of exposure that we evaluate and then we look at the toxicological information and what health information is available. So, that is part of the work. Alright, I’m going to switch now and tell you very quickly about recommendations. I’m going to keep this fairly general because again they’re going to be, they could be vastly different from one public health assessment and from one site to another. So, recommendations are made to identify practical ways to stop, reduce, or prevent exposure; activities to further characterize the site and possible exposure; and health activities that are service or research oriented, such as medical monitoring, health education, health studies, health surveillance, or a substance specific research. Those are wide categories so it means the recommendations can cover a lot of territory. And in the next slide I have some examples of these and I’m not going to read them all except to point out again that the headings are: actions to cease or reduce exposures; actions for site characterization; and at the bottom here health activities, which may include education or conducting other types of research. Now, there are many more examples and I didn’t bring lists of those for you. I just wanted to touch on the fact that recommendations can cover a wide variety of issues. Next, I want to tell you what a public health action plan is. It’s a part of the public health assessment, and this is wording I took right out of the guidance manual. Public health assessment must include a plan that clearly describes the implementation and timing of recommended public health actions. Public health action plans outline actions or activities that have already been taken to protect public health, activities that are currently under way, and activities that will be conducted in the future. And the footnote reads: If the site poses no public health hazard that is conclusion Category Number 5 a public health action plan may not be necessary. Now, what this all says is that it’s a way of framing the recommendations. It’s an elaboration. It’s a little bit more than just sticking recommendations with no explanation; it’s a little bit of background and it specifies the timing of any intended activities. The recommendations can be made to different organizations and agencies. They may go to EPA, for example, and they may be for other parts of ATSDR or other local health authorities.
MR. WASHINGTON: It was brought to our attention some time ago that at one time during the distant past near K-25 there was a very viable community there, two or three hundred people. And that community no longer exists, but we had some people come to the committee and tell us that various people died of all kinds of illnesses. Would that be instructive to include in this study? Could we look for some of those people who lived in that community? Would that shed some light on what we are doing or would it just confuse the issue?
DR. TAYLOR: It may be important. We have a separate public health assessment for the K-25 releases and the communities that were impacted by those releases will be looked at separately from the public health assessment for the Y-12 Uranium releases. That’s part of the work that’s coming. This is my last slide. I’ve listed some possible factors to consider when developing the recommendations and the public health action plan. You have these in front of you and I won’t read them to you. It’s just a variety of issues that we, as public health assessors, take into consideration. That’s all I have. Are there any more questions? Mr. Lewis?
MR. LEWIS: I have a comment. I’d like to thank you for a presentation that, in my opinion, is very late. I really feel that I sort of pushed to have this done. The whole concept of what’s captured in this guidance manual I think would be beneficial to us if we had a good preview of what they do and how they do it. I’ve taken time to try to read these things and study it. I hope this has been helpful. I would like to see us look at having some real presentation given to us so that we’ll all be aware of what we’re trying to do or at least what we’re looking at. I think it would be helpful to the community and to the subcommittee. I hope that could be taken into consideration at a later date.
DR. DAVIDSON: Thanks, Bill.