Oak Ridge Reservation: Public Health Assessment Work Group
Public Health Assessment Work Group
October 15, 2001 - Meeting Minutes
- Approve minutes of PHA WG meetings on 9/17/01 and 10/01/01 - Bill
Pardue (Draft minutes have been sent out for 9/17 and will be sent out
for 10/01 next week; please review before the meeting.)
- Discuss draft letter to Dr. Koplan, Administrator, ATSDR, regarding
environmental sampling in Scarboro - Kowetha Davidson (Draft letter
and recommendation will be sent out for review before the meeting.)
- Discuss draft letter to ATSDR on need for secretarial support for
ORRHES activities - Bill Pardue (Draft letter and recommendation will
be sent out for review before the meeting.)
- Take action on draft resolution on the Mangano report for presentation
to ORRHES - Al Brooks (Draft resolution will be sent out for review
before the meeting.)
- Prioritization of issues for I-131 - Bill Pardue
Michael Grayson, ATSDR
Jack Hanley, ATSDR
Bill Murray, ATSDR
The meeting was called to order by Bill Pardue, PHAWG Chair, at ~5:30 p.m., and introductions were made around the room.
Announcement: Al Brooks resigned both the Work Group and the ORRHES, effective October 9, 2001, because of health reasons. Dr. Brooks has worked diligently on these issues for many years, and his presence will be missed. However, he has agreed to help out occasionally, when possible.
Motion was made for approval of the Agenda for tonight's meeting. All in favor, none opposed.
Bob Craig moved to approve the draft minutes of the 10/01/2001 PHAWG Meeting, correcting the spelling of George Gartseff's name. Susan Kaplan seconded.
Draft Letter to Dr. Koplan: Minutes of the 10/01/2001 meeting did not reflect changes discussed in the meeting, but the recorder did mark up the draft of the letter handed out. Everyone did not come away with the same recollection about changes agreed upon. The recorder will append the marked-up draft of the letter to Dr. Koplan to the 10-01-2001 minutes.
Page 10, 3rd paragraph, last sentence: Bob Eklund said this sentence should read: "He also commented that some people said that the medical community . . ." (Karen check tapes, then Pardue will check tapes, then Bob said leave as is.)
All in favor of approving 10-01-2001 PHAWG Meeting Minutes (with above-mentioned changes), none opposed.
- Unfinished Business
- Matrix on Mangano Report (James Lewis)
James Lewis handed out a draft copy of the Matrix. This copy represents all efforts performed on Mangano report. The way to close an item is to document it on a worksheet.The 1st column represents the questions raised by Lucy Peipins in the 08/28/2001 Workshop (i.e., the basic set of questions anyone should ask to evaluate any epidemiology study).The 2nd column represents the statements found within the Mangano Report in answer to the set of questions in 1st column.The 3rd column represents the discussion and issues considered by the PHAWG members in order to make a finding about each question.The 4th column represents the Work Group's findings about each question. By documenting in logical sequence the thought process and discussion points related to each question, we hope to put to rest issues concerning PHAWG's evaluation of the Mangano Report. Prior to Lucy Peipins' Workshop, most PHAWG members did feel that that the Mangano Report did warrant further review; after we went through Lucy's process of logical evaluation, the consensus was that no further time or consideration should be expended on this report.This Matrix should support the Resolution being presented. We all thought Lucy Peipins' Part II Presentation would have taken place (at the September 11 ORRHES Meeting which was abbreviated because of the "Attack on America") before PHAWG presented a Resolution to the Subcommittee. But that part will not change the Resolution.Bill Pardue thanked James Lewis for all his work on this Matrix. It will help PHAWG's efforts enormously in reviewing this and other epidemiology studies in a defensible manner.Kowetha Davidson stated that there were also discussions on each hypothesis (within the Mangano report), and they should be all documented in the Matrix because a key issue is whether or not Mangano proved his hypotheses.James Lewis stated that he put the Matrix together working from the 08/28/2001 PHAWG Meeting Minutes (which were not detailed enough to include these discussions); he has not yet reviewed the tapes of that meeting for more detail.Kowetha Davidson said she will provide that information for James to include in the Matrix.
Bill Pardue said it appears we're not ready to approve the Matrix at this time. Lucy Peipins is on the 12/04-05/2001 ORRHES Meeting Agenda (to give Part II of her presentation). James Lewis should finish the Matrix with Kowetha's input; the final form should be ready by the next PHAWG Meeting (11/05/2001).
- Resolution on Mangano Report (Bill Pardue)
- Draft Letter to Dr. Koplan (Kowetha Davidson)
- Draft Letter on Technical Support for Field Office
- Prioritization of Issues for I-131
The Resolution has been prepared. It's a Recommendation for Subcommittee action at next ORRHES meeting (12/04-05/2001). The Resolution will be sent out in the package for the upcoming December ORRHES Meeting 2 weeks prior to the meeting. Kowetha did comment that Lucy Peipins' presentation should be (on the Agenda of the 12/04-05/2001 ORRHES Meeting) BEFORE this Resolution. Reminder: We've discussed this for two or three meetings, viewed the video of Mr. Mangano being interviewed about his paper, and Al has made changes that we requested at the last PHAWG Meeting.
Kowetha had revised this letter incorporating most of the changes mentioned in the October 1 meeting.
Linda Gass asked about the "lead agency," which was mentioned several times. In the past, she has attended several community meetings where EPA stated emphatically that DOE is the lead agency in this effort. DOE has the money, and and does the work. However, others feel that EPA is the lead agency because they developed the plan, carried out the plan, and have accountability for it. Kowetha Davidson stated that she asked that very question of EPA (who is the lead agency), and did not get an answer.
Bill Pardue asked for a motion to approve this so we can discuss it as far as a motion. Bob Eklund moved that we approve it. David Johnson seconded.
There was a little more discussion about who is the lead agency. In the end, it was generally agreed that it is not appropriate to name a lead agency in this letter.
James Lewis wanted a statement included verbatim from Item 6 from Core Values about Practice of Public Participation (whether it was or was not utilized) that we discussed and agreed upon at the last meeting. It was agreed that this statement would be included in the revised draft.
James Lewis made a motion to amend the main motion so that the 3rd sentence of the 1st paragraph should read as follows: "These plans were finalized by the EPA without communicating to the public participants how their input was or was not utilized and why." David Johnson seconded. All in favor; none opposed.
James stated the reason why he wants to see this wording in the letter is because EPA has not met the requirements of Item 6 of their own Core Values (responding to community concerns). Linda Gass disagreed. She said EPA has stated in lots of cases that community members/groups have contacted them (some not necessarily wanting to be identified). In fact, the EPA representative at the presentation asked for direction on which group represents "this community" - is it ORRHES, SOCUM, ORJEC, etc., or is it the little lady who calls and wants her soil checked because 2 or 3 generations have been sick. So it is apparent that EPA has responded to community input.
Bill Pardue agreed and said that there were two meetings to review the Draft Scarboro Sampling Plan which were broadly attended by the most of those segments of the community just mentioned by Ms. Gass. The disappointment of attendees was not that their suggestions were not accepted; it was that they got no response at all.
L.C. Manley commented that at those meetings, Mr. Gibson expressed himself very well about the testing in Scarboro; Mr. Gibson and many others who share his views were totally ignored by EPA. People on the opposite side of the issue from Mr. Gibson were the only ones who got a response from EPA. He felt the reason may have been that the NAACP was put out front. CJOC Head was the Head of NAACP; that puts pressure on EPA.
James Lewis added that he has a documented copy of positions of the various environmental groups which were submitted to John Johnson in writing with his underling present. Each of the groups did their own summaries of their positions and submitted them to the SSAB; the SSAB submitted to John Johnson. When Mr. Johnson was asked for a response to the group's positions, he stated he hadn't seen the letter, but they had it right in front of him. Mr. Lewis said if he didn't know about this organized effort first-hand, he would agree with Mrs. Gass about EPA's response to the community. Mrs. Gass was not aware of this and expressed her desire to look at this documentation. James will provide her a copy.
Bill Pardue asked for a vote on the Main Motion of submitting this letter to the full Subcommittee as a Recommendation as amended by the one change one change (3rd sentence of 1st paragraph), and allowing Kowetha Davidson some editorial freedom. Nine (9) votes in favor, 1 opposed (Linda Gass); motion passes.
On the copy list (or distribution list), someone still needs to determine who at the Tennessee Department of Health should receive this letter. (There was a mix-up in the pages of the hand-outs between this letter to Dr. Koplan and the letter on technical support for the Oak Ridge Field Office. The mix-up only pertained to the pages subsequent to the cover pages. Therefore we didn't realize the mistake until we addressed the next agenda item.)
Bill Pardue asked and Linda Gass volunteered to run this portion of the meeting because Bill Pardue is making this motion.
Pardue had an revised draft which reflected comments received in the 10-01-2001 PHAWG Meeting. He tried to be more complimentary of ATSDR for providing the support we currently have.
Bill Pardue made a motion that PHAWG approve this letter to be submitted to the full Subcommittee for their action. Bob Craig seconded.
The consensus was that this letter should be directed to Dr. Faulk and copied to Jerry Perrari, Jack Hanley, Bert Cooper, Bob Williams, Sandy Isaacs, and Lafreta Dalton at ATSDR. If it's sent to all ORRHES members, it should also be sent to the non-voting members (e.g., Brenda Vowell, Elmer Aiken, etc.), and it would be up to them whether or not to take it to their management within their own agencies.
Bill Pardue said that another major item that he changed was to emphasize administrative support instead of clerical. We need someone who can interact with the public and contribute, not just a file clerk/typist.
James Lewis said we have to look at the needs of the position - some clerical needs, some secretarial, some technical. The administrative function of running this office in order to meet the needs of the community is key. ATSDR needs to come in a look at operation and identify the needs. Work groups need administrative support similar to what's provided for the Subcommittee (but not to that level).
Bill Pardue: In his experience in dealing with agencies, it's best that you don't ask the agency to define the type of support you need. We need state exactly what type and level of support we need. We won't get the same diversity of support as the Subcommittee gets. We just need basic things we're not getting now. We've addressed everything in the letter (office hours, etc.).
Pete Malmquist said that the letter talks about Oak Ridge, but does not address surrounding area . Actually, two of the Oak Ridge plants are in the City of Oak Ridge, but in a different county. Bill Murray suggessted that we describe the area served as "the Oak Ridge area, as reflected by your own Health Needs Assessment." The area served by this office regarding these health issues encompasses parts of 8 counties; that would reinforce our position.
James Lewis thought we should lead with paragraph #2 instead of paragraph #1. But Bill Pardue said if he did that, he'd have to rewrite most of both paragraphs because the letter would not flow well then. He opted to leave it as is.
Linda Gass stated that Oak Ridge issues pale in comparison to other needed uses of ATSDR's resources since September 11, 2001. ATSDR is 400-person agency to serve the whole United States. Point well taken. Pardue agrees that ATSDR has more important things at this time also. James Lewis agreed also, and emphasized that we might work more effectively (taking up less ATSDR resources) if we were better organized.
Bill Pardue's Amendment to the Main Motion: "This need is exacerbated by the fact that citizens of 8 counties are affected by our activities, as acknowledged by the scope of the Public Health Needs Assessment." (This will go at the end of 2nd paragraph.)
Restating of Main Motion: I recommend that we approve this letter for submission to the full Subcommittee for their action, with the added statement (above).
Nine (9) votes in favor, 1 opposed (Gass). Motion passes.
At our 09/17/2001 meeting, we came up with a list of I-131 issues without any prioritization. We now need to prioritize them. We invited Michael here to help us with this. We hope to get presentation from ATSDR on these things to decide what recommendation to make.
Linda Gass suggested that some issues on the list do not greatly change outcome. She believes the most important item on the list is getting all the sources (source terms). Bob Peele said probably lots of small releases that weren't identified. Altogether, those small releases could form a substantial amount of iodine. The second most important item on the list as she sees it is the transfer coefficient factors. She said this effort is rehashing the same discussions that have gone on for the last 9 years - a waste of money and resources.
Bob Craig said the real question we will address is indeed whether all the small releases together form a substantial amount of iodine when compared to the releases from RaLa. The first run-through this said no: it appeared releases from RaLa were much larger than everything else, therefore everything else was "noise." What was found upon closer examination (by Bob Peele) of the RaLa operations was that they were better controlled than was first thought. So in comparison to the size of smaller releases from RaLa, a combination of smaller releases might be more significant. He still believes if we can address the RaLa releases, that addresses the most significant exposure to the affected area.
Bill Pardue: Let's assume the RaLa numbers were in ballpark of "real." Assume you do add in Nevada fallout (we've not decided this). Assume lot of other sources are added in. It still appears that all these other sources combined will not exceed the RaLa releases. Then we're probably still talking >150 health effects over a 70-year period. Even if we identified some major source term, thte likelihood is that ATSDR will say they cannot afford the time or money to go through another dose reconstruction on that. Maybe we should do best case and worst case (100-150 potential health effects) and say to ourselves that we will never know exactly how many, even if we had good data. Therefore, the most time- and cost-effective measure we can take is to make a Recommendstion to ATSDR for their Public Health Assessment to say something like if you're female, if your born between years ~1935 and ~1960, if you lived in affected area, and/or if you drank backyard cows milk, goats milk, etc., get to your doctor and get checked for thyroid cancer and ATSDR will pay for it. In the end, it will be quicker, cheaper, etc. If you go through all these dose reconstructions, we still don't know who the individuals are so there is still going to have to be this recommendation made for them to get to their doctor and be checked.
ATSDR should make information well known to the medical community as well as the general public.
This is the approach that Charlie Miller suggested he would take if he had a daughter with any of these risk factors - he would make sure she sought her physician to do thyroid screenings routinely (in response to a question by Susan Kaplan at the 09/11/2001 ORRHES Meeting). Susan Kaplan feels that this is a very practical and logical way to deal with the problem. Kowetha Davidson said it will boil down to that anyway - people being checked by physicians.
James Lewis: My problem is that if we don't "close" this issue and leave a documented trail to close it, we're not going to solve this. Mrs. Gass said she had reviewed the minutes of all these meetings for last 9 years and found that we're duplicating efforts of lots of work done in the past; how much time did it take her to review documents to allow her to think we're duplicating efforts. I assume a lot of time. Closure and documentation eliminates much work. She mentioned various other sources: Where do I go back and look for organized summaries (of all these efforts)? If I can see documentation of why the findings of all these other studies don't need to be considered, then I could move to your position (ATSDR put Recommendation in PHA that women between ages . . . go to their physicians and be checked for thyroid cancer) as the solution to this issue.
Kowetha Davidson asked Linda Gass if she has a guesstimate in her mind, including all the other sources, as to what percent RaLa process would have contributed. If so, does she think it would affect he bottom-line conclusion? Mrs. Gass said she doesn't know and doesn't think she's going to know. As she pointed out before, she does not think we should devote more time and resources to this effort for something we're not going to know. There's a disconnect between information coming to ORRHES (about 8-county area) and the information being given at the Labor Department compensation program (about workers). We need to know information about workers in order to make assumptions on wider 8-county area.
Bill Pardue: It doesn't make any difference. RaLa did expose people to iodine, and there probably are health effects. People still have to be advised to go to their doctors and be checked for thyroid cancer. Kowetha Davidson added that workers were no the most sensitive population to radioactiv iodine - children residing in the affected area outside the gates were the most sensitive population. Bob Eklund commented that we owe some explanation to the public: a paragraph about the uncertainties, specifically that we don't know what percent RaLa and other sources contribute. Susan Kaplan said, however, that we do know the category of people at risk so maybe it really it just an outreach issue.
Bill Pardue addressed James' earlier point: If we go with this approach (or some variation of it), we do indeed need to make documented connection showing how we got to this approach, document uncertainties, etc. James stated that because there are volumes of documentation on previous efforts, ATSDR make summary information available to us which can be used to make the connection between the previously considered approaches and the one we're considering now.
Michael Grayson was asked if ATSDR can do this for us (an "executive summary" of the conclusions of dose reconstruction as it relates to the work of PHAWG that shows what were sources, large or small; something that helps us look at the big picture relating to iodine-131). James Lewis said if they can provide these summaries, he could feel comfortable that we have a good basis for our conclusion.
Susan Kaplan: Needs to go one step further because there has been a lot of discussion about things that may have been missed. So maybe we need to identify things we think may have been missed. But we also need to say that none of that may be important, because none of this affects bottom line (bottom line again being - go to your doctor and be checked if you are in the potentially impacted group). Even if we spent $100M on additional dose reconstructions, it wouldn't change the final recommendation.
Bob Eklund: In addition to stating why it's not important, it should also be stated why this information is impossible to get at this time.
Kowetha Davidson: Exposure scenario and exposure dose should be covered.
Michael Grayson stated that as a general rule, he doesn't spend much
time on background. When he works on a team, the lead health assessor
(Jack Hanley) writes background. Grayson is the technical person.
Grayson begins PHAs by writing Exposure Scenarios (already done in
Bill Pardue: You're talking about writing the PHA; we're talking about recommendation that we make before the PHA is written that gives ATSDR advice on what we think should be addressed in the PHA.
It was indicated to Michael Grayson what we feel PHAWG needs is a brief introduction of general pathways of how someone gets exposed specific to the Oak Ridge site, and that he should deal with controversial issues not addressed in dose reconstruction.
Michael Grayson reiterated his original position that he takes dose estimates from the dose reconstruction and introduces them into the PHA.
A heated discussion ensued. Bill Pardue asked Jack (who will be in Oak Ridge this Friday) if he would get together with small group of volunteers and summarize what we'd like to see in a background document.
Michael Grayson stated that we've had these types of discussions in Atlanta and that Jack cannot tell us what he will do.
L.C. Manley spoke up to say if the Work Group doesn't want to listen to Michael, why to invite him here. Mr. Manley asked why exactly Michael was invited to the meeting; Bill Pardue said he was invited to help us with the prioritization of the list of issues related to iodine-131, but now what we're exploring is the chance of not even having to address the prioritization. L.C. was concerned that we're talking down to Michael. Bill Pardue said he doesn't think so, but if we did, he apologized. Mr. Pardue said we're not trying to make Michael feel bad, but the Work Group just wants something different.
James Lewis: Mike said consistently he is not responsible for reviewing or generating any summaries of dose reconstruction.
Jack Hanley: To address something Susan Kaplan said earlier, there may be outstanding issues people in communities may be concerned about. One thing we do in a health assessment is address community health concerns. If there are community concerns, we'll list them in a document and prepare a paragraph to explain that issue. If it's related to the Public Health Assessment, we address it; if not, we'll tell them who to go to in order to get an answer.
Bill Pardue: What we're looking for is a document to back up our PHAWG's approach that goes into the record. We are asking help from ATSDR.
James Lewis: To summarize, I don't think we can make that "leap of faith" without having some underpinning; in other words, I'm not just going to jump straight to the final document that he's talking about for the health assessment without having something that makes the connection for me (doesn't have to be a "solid bridge").
Susan: Michael's comments relate to an effort independent from what we're asking for; they're related and they should match, but basically what we need is a summary that helps us lay out the rationale that will be discussed in detail in your document.
Jack Hanley: We need a few more specifics than that. Suggest that the Work Group work up something to explain more fully what you want. I see you have these 12 items . . .
Bill Pardue: We're trying to work on a solution whereby we can set aside these 12 items and not addressing them. That was part of the motivation of my proposal.
Jack Hanley: OK, I'm still trying to grasp - a summary about what?
Kowetha: What want is with the outstanding issues we have (source term, uncertainty, confidence interval, central value, adding other sources (like NTS), use of thyroid vs. total body dose) how do these things impact the final assessment. What effect would it have if we have other source terms? Uncertainty analysis - will that have an impact? what type of impact? Whether to use the confidence interval or central value - what would be the difference in the estimate between the two? When you come to the final conclusion, will any of this matter in the Recommendation? If you add other sources to ORNL releases, what impact will this have on assessment - will it increase the number of expected cancers? Does it make a difference as far as what the final Recommendation will be because you'll still have to go to the doctor and get checked? Will each of these make a difference? If so, how big?
Linda Gass: What we've heard for 10 or 15 minutes is detailed explanations of why not to do a standard PHA. The standard product that ATSDR does is not appropriate for Oak Ridge. Twenty or 30 pages of explanation is what I'm hearing that being asked for of why not to do a standard PHA. This is basically a waste of time and money; these issues have ben studied. This Committee has spent 10 months; others have spent years on it.
Jack Hanley: ATSDR is not going to redo all work. What trying to do is present what has previously been done to the Subcommittee.
Pete Malmquist: Michael (Grayson), would your report that you'll write answer Kowetha's questions?
Michael Grayson: It wouldn't answer it in terms of if a lot more exposure occurred, if the doses were much higher . . .
Pete Malmquist: Not the "what if," you're going to take the dose reconstruction that you have. In your report, using those figures, would that answer Kowetha's questions?
Michael Grayson: Sure. Yes. What we need to do is document community health concerns people have. This diagram (Process Flow Sheet for the Oak Ridge Reservation Public Health Assessment, Draft, 8/24/01) reflects starting from scratch to do a health assessment. But because we already have a dose reconstruction, a lot of this material up here is not applicable. We need Public Availability Sessions and document community concerns people have. One thing the Work Group or Subcommittee can do is put together a list of specific questions they would like addressed, and I think you've already come up with some very good questions. When get those questions, yes we can address those concerns in the PHA along with any other community health concerns. One problem: we already have doses and exposures scenarios, but we haven't had Public Availability Sessions. We have answers and we're trying to rush to the end. Charlie (Miller) is right on the money: it doesn't matter what the dose is; the Recommendation will be same. The problem is: if we want to go through all steps (of the process) . . .
Susan Kaplan: The ball is rolling; they're going to do this study. We need something similar to the workflow sheet. We have outstanding issues of exposure; we need potential impacts to persons. I would like to see a chart like that for every contaminant of concern.
Jack Hanley: What you're talking about is exactly what we do in a Public Health Assessment.
Bob Eklund: What Michael did was to point out how the process is important. One important step is getting communities' concerns addressed. We were concerned earlier that we got no response from EPA. We would have been more satisfied if they would have responded by saying, "these are the reasons why we didn't use this or didn't use that." By giving the public chance to give their concerns and having someone responding to those is an important part of the process.
James Lewis: Agrees with Bob Eklund. It is crucial. Some type of summary needs to be done because people have raised these issues.
Pardue: We need an acceptable summary of these 12 issues we have
here (handout attached to the minutes). We have not been able to resolve
them to our satisfaction. Even being able to resolve them, the bottom
line is still: go see your family physician if you met these criteria.
Linda Gass: I would like to make a motion that the Subcommittee consider writing an explanation which would address these issues in lieu of a conventional PHA. Bob Eklund seconded the motion. As you (Michael) said, you've already got things, and it's based on doses; we don't know those doses, and we don't know many parts of the puzzle.
Michael Grayson: We have dose estimates, and we have probabilities associated with each dose estimate. Dose estimates typically look like log-normal curves. Demonstrating, Michael showed PHAWG where central tendencies, upper bounds and lower bounds of subjective confidence intervals lie. What I'm trying to do is to get probabilities associated with each of these values. And in our writeup for exposure doses, I will considering providing three values: the lower level of the subjective confidence interval with its associated probability of being the correct actual dose estimate, the central tendency value with its associated probability of being the correct actual dose estimate, and the upper level of the subjective confidence interval with its associated probability of being correct the dose estimate. That would go in here in terms of exposure dose. As for health implications, towards the end of this dose discussion, ATSDR would have to say which one of these values we think we have the most confidence in. What ATSDR would like to do is use whichever one of these has the highest probability is the value we would like to use in this area describing public health implications.
Bill Pardue: What's the probably that your analysis will be different than ORHASP analysis?
Michael Grayson: It's value. Upper bound of the subjective confidence interval and when we get a look at the output of the uncertainty analysis, what I see in this community and other communities is people begin to focus on these values (those 10, those 12, those 8).
Bill Pardue: That's not really my question. I appreciate what you're saying, but my question is: Just as a professional, I think you should be able to make some judgment of what the difference between the dose reconstruction and the health effects that came out of ORHASP and the health effects predicted out of this one. Is it 10%? 100%?
Michael Grayson: In general, our values will be 10 times to sometimes maybe 50 times lower than ORHASP because we're not using largest values, using values with largest probability of being correct.
Bob Eklund: If that's based on the ORHASP dose estimate, that is not going to include what we've been talking about. So we may decide that even if the central value is the most probable for ORHASP, it might not be what we want to include to support our conclusion. We might want to use the upper limit. We might also want to use a range instead of one value.
Michael Grayson: These are the problems I face. I can talk about ranges here, but eventually I have to make a conclusion and a Recommendation. Problem is range is too wide - in some cases it's 1000X, sometimes it's only 100X. We have to make a conclusion . ATSDR does not like numerical ?risks?, they like qualitative descriptions. So after I calculate doses, I have to calculate risk and I have to describe them qualitatively. The breakdown of qualitative descriptors are in increments of 10 (e.g., 10-1, 10-2, 10-3). It's hard to make a conclusion if the range goes from 10-1 to 10-3 because 10-1 means urgent public health threat and we have to ?move? people immediately; but with 10-3, we don't have to take those kinds of actions. This is why I have problems writing about entire range. I can write about an entire range here, but what we have to do in public health is first we have to identify the problem, then study and research the problem, then make a finding about the problem. That finding cannot be a range of 10X to 1000X. In public health, we can't do this. However, if the range was 6.8 × 10-4 to 9.8 × 10-4, I could do that. When I look at my table and I have to come up with a qualitative description of this range, I can do that because it's all within an order of magnitude.
Bob Eklund: Isn't this within a very low order of magnitude already, even if you use the upper limit?
Linda Gass: Mr. Grayson, thank you. You have spoken most eloquently in support of my motion. Everything you said was a wonderful explanation in support of my motion. The fact is that you're doing violence to the science in the orders of magnitude if you try to cut through and come to the standard way of ATSDR doing this. It doesn't apply here. We have this very wide range of uncertainty. My Masters research was in hyper___conductivity, and it doesn't matter if it's 6.8 or 9.8, if you're off by orders of magnitude. I taught in science orders of magnitude. It really doesn't matter - if you're doing violence to the science, don't do it, PLEASE!.
James Lewis: Regarding the first bullet: Combining I-131 Doses - Michael, what is ATSDR's position on that first bullet?
Michael Grayson: As the health physicist writing that portion of the document, my response is to look at the I-131 Report put out by the National Academy of Sciences; it says doses from NTS are so uncertain that they would not recommend using those doses at county or individual level. They're OK to use as a national indicator of the types of exposures people have on a national level. However, there are seven places around the U.S. where there are monitoring stations, but they're not there to specifically measure I-131. One area might have had one way of looking at some type of radioactive material and they're able to determine from their measurements what contribution I-131 had. Another area of the country may have had a totally different way of measuring radioactivity in the atmosphere, and they came up with their crude estimates of how much I-131 contributed to their measurements. The folks that looked at all the doses around the U.S. said because the crude measuring stations were not set up to measure I-131, they would not recommend using NTS dose estimates at state, county, or individual level. My recommendation would be not to combine doses. If you go back and look at Charlie Miller's handouts at beginning of his presentation, it says "Should We Combine?" In the middle of his presentation he said "Yes, We Can Combine" (technically, we can), but at the end of his presentation he asked again "Should We Combine?" The problem is that those estimates are so uncertain that we should not combine NTS doses with other doses around the country. Charlie didn't say that explicitly because he didn't ever answer the question. I guess he was hoping that we would get this out of the presentation. He asked us at the beginning; he said in the middle that we can technically, but he asked us again at the end.
James Lewis: We as a Subcommittee or Work Group have not made that decision yet. Let's make the assumption that we vote to combine doses; what impact does that have on what you have to do? What happens then?
L.C. Manley: We were asked to study health effects from the ORR. That's our primary objective. So we're being asked to add something to our task
James Lewis: I agree with you, but if we decide after listening to this presentation that we want to add that, what does that do to you? The same as what you just said?.
Michael Grayson: No, within the Agency the process is already set up for the National Center for Environmental Health (NCH) to do it. Charlie (Miller) said if they have resources and they get the task, they can do it. I'm just giving you my professional opinion on adding doses. But if you as a Work Group want recommend to the Subcommittee, and the Subcommittee votes to add doses, ATSDR would say there's already a group that adds doses and they would refer it over to NCH.
James Lewis: If we were to get a detailed summary similar to that, then I could put that issue to bed in my mind.
Kowetha Davidson: You wanted a rationale for combining or not combining from the ATSDR. If we decide not to combine, are you asking them to provide a rationale for not doing it?
James Lewis: No, my point is if we as a Work Group or Subcommittee decide to combine doses, or even if we don't, I think we need some type of summary similar to what we just heard that states the position.
Kowetha Davidson: But he just said if we do decide to combine he would do something different; he would send it off.
Bob Eklund: If you're trying to do a PHA and give people a reasonable idea of what their health risks are, if there's I-131 both from ORR and NTS, it's in this area and affecting the public heath. If you ignore the NTS part of it, you won't get accurate health assessment unless unless our data is so uncertain and we're so conservative on our conclusions that it covers it anyway. Before I would want to approve not adding NTS data in, I'd want to know if would have any affect in the end.
Bill Pardue: The basic question is do we add sources. Iodine-131 from ORNL/Oak Ridge has to be in the assessment - no question about that. But then you look at the NTS and iodine; if you carry that logic to the extreme, you also must include Chernobyl, and on and on. You could add at least a dozen sources of I-131, many of them so small that they're not going to impact at all. Follow on: if we accept that we add other sources to Oak Ridge sources, then what about lead, Gasoline from automobiles, fallout from TVA because they emit uranium and thorium, etc..
Bob Craig: I think L.C. (Manley) made our case. Our job is to look at what is the impact at from ORR on top of whatever else is there. Everybody gets fallout from Chernobyl, everybody gets NTS. But our job is to look at what we got from Oak Ridge, and through some very exhaustive studies, we have good dose reconstruction.
Linda Gass: My motion is pending. I do believe all the earlier discussions are n explanation of exactly why coming out with numbers with so much uncertainty in there (in the dose reconstruction) supports doing lengthy explanations rather than numbers. The experts were very subjective about the confidence in various aspects about input - they didn't have any hard input.
Bill Murray: The correct term is not adding doses,' it's combining doses.' That makes it much more difficult. Charlie (Miller) said there's no way we can do it without developing a methodology, and I don't believe that's something the Agency would do. We would take the Recommendation from the Subcommittee over to NCH and say "Here it is, guys; figure it out. This is what the Subcommitee wants." The other point we've got to keep going back to is one that you and Charlie Miller made. Someone specifically asked him, "If it were your daughter, what would you do?" He said I'd get her to the doctor. It all comes down to the same thing.
James Lewis: What Bob and Bill (and Charlie) said makes sense to me, in this particular case, we've got a situation where we can close the report and focus on what our charter is. At the same time, there is a process NCI is looking at to evaluate this. But it has all pieces for closure as far as our effort, and an open-ended line to handle if someone sees fit. My question is, "What do we do with the others (if we forego process).
Bob Eklund: Regarding the question on others: if we set example by including the iodine at the NTS, then yes we would be more likely to add lead, arsenic, etc. But to me, that's just as or maybe more important. About a year ago in ____ Environmental Weekly, they had a series of 3 scientific descriptions entitled, "Dumbing Down the Children," explaining how lead is really lowering the IQ of children in this country in certain social-economic groups across borders, not just poor people. So I think lead is more of a health concern, not from Oak Ridge, but it's an issue in this Public Health Assessment. Look at arsenic: we've heard from one woman who grew up in this community who is being chelated for arsenic. Where did she get the arsenic? She probably got some from Oak Ridge, but probably got a lot from TVA. Nevertheless, it's a big health risk for a member of our community who grew up in her situation. It's part of our Public Health Assessment. (Bill Pardue agreed with Bob.)
L.C. Manley: Back in the 1950s and 1960s when they were doing a lot of testing, strontium was big worry. I'd never heard of I-131. Everyone was concerned then about health effects from strontium. Now all this talk about I-131. All of this was from same fallout (I-131 and strontium). Strontium pathway is basically the same as iodine.
James Lewis: I recently watched C-SPAN when the new Secretary (Head of EPA) was on there. They're still arguing about acceptable levels of arsenic. This is something she is trying to get established. If it can't be established at the highest levels in the land, as long as you know something else is in place in general, I think that we should devert toward the process the country has in place to address that issue. We can only address is assigned to us to deal with.
Bob Eklund: In the Public Concerns, we will hear these questions over and over: Why am I sick? Why are heavy metals in my blood? If we just say "the Oak Ridge weapons factory has only put out this much, so you could not have gotten that from Oak Ridge Reservation, that won't address the public health issue.
Bill Pardue: Why are we writing this PHA? In my understanding, it is because we are a Superfund Site and we're to evaluation the effects of the Reservation (if that's true - don't know for sure).
Linda Gass: Jack Hanley, it has been waived on other Superfund Sites; Congress has waived that requirement that we do PHAs on all Superfund Sites, is that correct?
Jack Hanley: No, it is mandated.
Linda Gass: Mandated, but it has been waived a number of times, hasn't it?
Jack Hanley: No, we do health assessments on all National Priority List sites. There's a lot of flexibility in doing a health assessment. To address Bill's question, for Oak Ridge, I think there is a clear rationale for doing PHA in Oak Ridge. The health assessment is going to take all this previous information and studies looking at all these issues and bring it all together. For ATSDR, the health assessment is the first thing; it's a triage to figure out who was exposed, what they were exposed to, if they have a health problem, and what we should do to address that problem. Then you have the Recommendations to followup so that it's a prerequisite to doing other public health actions. By identifying exposures, determining if it's a problem, and determining what needs to be done, that leads to the Recommendation. And we're trying to bring this community along with us through this process to go through it. If there's other ways that we can communicate this and bring it up, we're willing to listen to some of that. And exactly how the document is written there's flexibility in there and we're able to work with you on that. The main thing is to communicate to the public what the overall implications are and what they need to do, and what can we do for them; and should there be a more definitive investigation or is this enough? More educational/informational?
Susan Kaplan: Jack raised a good point. The PHA will have a Recommendation section so all these other issues are confounding issues. If our mission is only to address ORR issues, all the other issues need at least to be mentioned as possible future actions before a final decision is made. But what is the bottom line? Is the goal for each person who ends up getting sick to come up with a number to petition the government for benefits? Or is this strictly a qualitative thing where we say, "you need to go see your own doctor." That's two very different issues.
Jack Hanley: Excellent point. This is very key. The health assessment deals with the general population. If you remember what Lucy says, public health/epidemiologic studies deal with general population. We're here to make public health decisions. We're not here to make legal or compensation issues. Remember Owen's presentation: He said dose reconstruction on iodine in the source term were good enough to make qualitative public health decisions. However, he said if we wanted to go back and do compensation/probability of causation number crunching, then we'd have to sharpen our pencils back on those source terms. He basically said that source terms are good enough to make practical public health decisions. This is about making public health decisions and followup recommendations.
Susan Kaplen: We're setting the stage for all future decisions like this. It's real important for us not to make decisions that are going to prevent it in the future where we're going to have to come back and totally redo things. If we're there, and can make some recommendations to make it easier to take that next step for compensation, maybe we need to just look at that and keep that in your mind. When we make a decision, should we weight it toward quantification (which is what you're going to need from a benefits standpoint).
Kowetha Davidson: Only if you have confidence in your numbers. You can't put a number out there if you don't know what that number means.
Susan Kaplan: That's exactly correct. That's why you have to put down all the confounding issues and discuss source terms you've not addressed, and lay out the whole uncertainty issue.
Bob Eklund: One more comment about Oak Ridge sources vs. other sources of all contaminants as it relates to the PHA: If we base our conclusions only on information about the Oak Ridge Reservation without considering any other public health sources, that's a very isolated thing. If we want a real and good assessment and real conclusions, we need as a base the health effects from base of contaminants (besides Oak Ridge) either layered on or combined from other sites. Contaminants, wherever they came from, affect health (whether its arsenic or lead or iodine or whatever).
James Lewis: Regarding Jack's comments, Owen made that position (source term good only for public health decisions) as related to the public. But Owen and Charlie also indicted there's a calculator out here, and if you want to go add up your own doses (estimates), you can go do that. That's double messages - you give one message to the public, then you give individuals something so they can decide what they want to do. That's where I think we're running into a problem. You have two options on the table: one was to make a call, but he also gave you something you could use so you could determine where you were in the sequence, then take it to your doctor and say "based on this, you need to do something." Does that exist for anything else out there?
Michael Grayson: I want to tie in conversations we're having. Bob is looking at the Vision Statement proposed for the Work Group and it says "To promote the health and well being of all the residents in the communities surrounding the ORR." He's talking about health and well being. I have worked on sites where ATSDR has looked at site-specific contaminants, their exposures, and their doses. We've also looked at other issues, other contaminants, that they wanted to look at. But we stayed very focused on the Mission that ATSDR had in terms of producing a PHA. We had a Work Group and we had Sub Work Groups. There were 6 issues from community members, 3 of which ATSDR had direct responsibility for. We brought in other agencies that had direct responsibilities for the other issues. Remember when ?Zolickman? and a lot of the other government agencies came to Oak Ridge, he used the term COMMUNICATIN FORUM. He didn't say FACA, he didn't say site-specific work, he said Communication Forum. I thought if I want to fall in the spirit in which we came to you all, when I look at this Vision Statement, I think it's possible that we can be very specific about the impact Oak Ridge has had on the community. I also think we can also begin to look at, at least in a broad sense, other contributing factors. If you think that arsenic is a concern in this area in terms of exposure and potential health effects, then the Work Group and Subcommittee can have presentations on it, get informed about it, and at least make Recommendations about it. But if you look down at Objectives, it says you all are going to make recommendations limited to health education and health promotion. You have to wonder if you're going to look at arsenic as a general contaminant that truly adversely affects the health of folks around here, what type of recommendation will you make if you limit yourselves to health education and promotion? This says what you all are about. I personally think ATSDR should be able to put up a complimentary mission statement so that when you get to a certain point, say for instance in the Vision Statement, you want to look at arsenic - there's a contribution that comes from Oak Ridge from other sources - if we have a complimentary Vision Statement, we're obligated to look at that and say "yes, we need to look at that as well, not just at a site-specific level, but in the general sense." We may not be able to calculate total dose (from all contributing sources), but we can say this is the Oak Ridge contribution, and we think it is a significant health threat for the general region (or not).
Bill Pardue: Michael, I like what you're saying, but I'm not sure I've seen that.
James Lewis: It came from reviewing some ATSDR Documents.
Susan Kaplan: It was supposed to have been discussed at the last Subcommittee meeting (but it was abbreviated, so it didn't happen).
Karen Galloway: I worked on the Ad Hoc Committee that is trying to
develop a Mission Statement for our Subcommittee. We met a few times
and came up with that piece of paper, and it was to be discussed at
the last Subcommittee meeting, but the meeting was abbreviated. It
was put on a table for people to pick up as they left and so they
could review it before the next Subcommittee meeting.
Bill Pardue: We have a motion (50 minutes ago). Karen, please read it back.
Karen Galloway: Linda Gass made a motion that the Subcommittee consider writing an explanation which would address these issues in lieu of a conventional PHA. Motion was seconded and discussed.
Kowetha Davidson: Point of clarification: When you say "in lieu of PHA," that means they won't do a PHA.
Bill Pardue: But ATSDR's going to do one anyway. If the motion passes (and I think I'm going to speak and vote in favor of it, quite frankly), then we've got to decide the mechanism of who is going to write that.
Kowetha: Yeah, that's what I get out of this motion - that we're recommending that ATSDR not do a Public Health Assessment.
<BREAK IN TAPE; ATTEMPT TO RE-WORD AND WRITE THE MOTION.>
Linda Gass: Not do their conventional product that they have done. But as you've explained, you've explained why we need to get a number. Not only do we not need it, but we really can't come up with a scientific number that's defensible because of too much uncertainty.
Bob Craig: ATSDR does PHAs at all CIRCLA sites. They do dozens of them; they do hundreds of them; they can do a fact-based, meaningful analysis right here in Oak Ridge that will add great value to the people and help us make public health decisions in this area relative to the ORR. We, as a group, if we say that isn't so, we are just speaking rediculously. These people can do this assessment, they have the data to do this assessment, and they can carry it out and it will be very helpful to this community.
Linda Gass: I'm not speaking rediculously, Sir.
Bob Craig: No, I'm sorry, that wasn't it at all; but as this group, if we think we can tell they can't do it, we're not speaking wisely.
Kowetha Davidson: What about "in addition to" rather than "in lieu of."
Linda Gass: Understanding that most of the PHA is already done, and I heard Jack and Mr. Lewis talking months ago saying most of the health assessment was already done, but I do believe we need these explanations about why - there is a lot of uncertainty in there and coming up with a single number is not appropriate.
Jack Hanley: That's a whole different question than if you should do a health assessment.
Susan Kaplan: Yes, that's a whole different thing than just not doing it - they're going to do it, but the key is to guide them enough to get something meaningful because A NUMBER is not going to be meaningful.
Jack Hanley: That's why we have a Subcommittee - to get input so that what we do IS meaningful.
Bob Eklund: Let's not forget about obtaining public health concerns - that is part of the public health assessment and it may be the most important part.
Susan Kaplan: That is not the document we've been talking about. It's almost a separate prelude to his document.
Linda Gass: The report precedes the availability sessions?
Michael Grayson: Availability sessions are supposed to occur as we do the data collection base. The reason I haven't written it is I know that we have not gone out and collected community health concerns. I don't like to begin to write and get invested in what I've written, and have to turn back and then come to you all and say, "I don't know the answer just yet" when I've already written it. I can look at the data and tell you pretty much the general direction we're headed; I've read a few books, but have not written. I don't like to write anything until we've talked with the community and found out what their concerns are. You all represent a portion of the community and you can give us some issues to work on, but I feel very strongly that we need to have public availability sessions because there are people who don't come to Work Group or Subcommittee Meetings whose issues you may not know. We don't write document until we do that.
Bill Pardue: There is a motion on the floor. Only option on motion is to postpone or amend to add language to it.
Bob Craig: I think the language Kowetha pointed out was "in lieu of" language, but Michael is going to do a qualitative analysis based on the information that he has and it will be extremely valuable. I don't think we do something in lieu of what he's going to do.
James Lewis: She said "conventional approach." I don't think she intended for everything to be thrown out.
Bill Pardue: Linda, would you accept this as an amendment to your motion?
Pete Malmquist: I move that we amend Linda Gass's motion to read "in addition to" to replace the words "in lieu of." Bob Eklund seconded the motion.
Linda Gass: My motion is to NOT DO a PHA that comes up with one number and explain why. My motion is to recommend that ATSDR not do a standard public health assessment that comes up with single number on iodine-131, and explain why (confounding issues, source term, uncertainties, etc. -- at least a 20- or 30-page detailed explanation).
Jack Hanley: When you say standard health assessment, sounds like you don't want to base a health assessment on a single point. There's a lot of flexibility in PHAs. If you don't want to use single point, let him know that.
Susan Kaplan: Not just the "single point." He's wanting to base it on the dose reconstruction that has left out several key points. It sounds like he's made up his mind that he's going to go calculate a number based on the dose reconstruction, and a number of us disagree with this.
Bill Pardue called for a vote on Pete Malmquist's amendment to Linda Gass's original motion. Eight (8) in favor, 2 opposed.
Bill Pardue called for a vote on Linda Gass's main motion as amended (ATSDR will prepare their traditional PHA; in addition to that, the Subcommittee we will prepare a summary of all the issues and explanation of them). Is that what everybody has agreed to? (Yes) Seven (7) in favor, 3 opposed, 1 abstained.
- Next meeting will be November 5, 2001, at 5:30 p.m.
- Meeting adjourned at 8:45 p.m.
1st and 3rd Monday