Oak Ridge Reservation: Public Health Assessment Work Group

Public Health Assessment Work Group

October 1, 2001 - Meeting Minutes

Agenda

1. Approve minutes of PHA WG meeting on 9/17/01 - Bill Pardue
   Draft minutes will be sent out early next week; please review before the meeting.)
   
2. Take action on draft resolution on the Mangano report for presentation to ORRHES - Al Brooks
   (Read attached draft resolution before the meeting.)
   
3. Discuss draft letter to Dr. Koplan, Administrator, ATSDR, regarding environmental sampling in Scarboro - Kowetha Davidson
   (Read attached draft letter before the meeting.)
   
4. Discuss draft letter to ATSDR on need for secretarial support for ORRHES activities - Bill Pardue
   (Read attached draft letter and recommendation before the meeting.)
   
5. Discussion of where the PHA WG goes from here, including discussion of uncertainty analysis and other issues raised in the past.

Attendees

Al Brooks
Kowetha Davidson
Bob Eklund
Karen Galloway
George Gartseff
Michael Grayson, ATSDR
Jack Hanley, ATSDR
Dave Johnson
Susan Kaplan
Jackie Kittrell
James Lewis
Pete Malmquist
L.C. Manley
Bill Murray, ATSDR
Bill Pardue
Paul Parsons, The Oak Ridger
Barbara Sonnenburg

Summary

The meeting was called to order by Bill Pardue, PHAWG Chair, at ~5:30 p.m., and introductions were made around the room.

1. Approval of September 17, 2001, PHAWG Meeting Minutes (Bill Pardue)

Almost everyone had problems downloading the file of the minutes from e?mail, so no one had time to review them properly. Bill Pardue will review the file and make changes, and send them for corrections by ~October 3. They will be approved in the next PHAWG meeting.

2. Status of Action Items (Bill Pardue)

Bill Pardue stated that he would like this agenda item (Status of Action Items) to be a standard tool to be used at all future PHAWG meetings to structure the meetings.

3. Approval of Agenda (Bill Pardue)

Regarding the Agenda for tonight's meeting (10/1/2001), it was agreed that Item #7 should end with the word "Reports." With that, the Agenda was approved.

4. Reports (Bill Pardue)

Work is not yet complete on the matrix (to document the process of PHAWG's reviews of epidemiological studies). James Lewis and Susan Kaplan will report on it at a future meeting.

5. Unfinished Business (Bill Pardue)
   
1. Draft resolution on Mangano Report

Al Brooks moved to make his resolution (passed out at the 9/17/2001 PHAWG meeting) a Recommendation to ORRHES. Pete Malmquist seconded.

Discussion:

Concern was expressed about making a Recommendation regarding the Mangano Report before the matrix that James Lewis and Susan Kaplan are working on is complete because the two are so closely related. However, it is not believed that the outcome of the matrix (on the Mangano Report) will be significantly different than what came out of the Work Group Meeting (08/28/2001). It was generally agreed that the matrix form would be the best way of presenting the topic to ORRHES; therefore, the matrix should be a part of PHAWG's Recommendation to ORRHES.

A question was raised about how PHAWG's evaluation of the Mangano report can be useful in the Public Health Assessment, since the Mangano Report does not deal with I-131. However, the Mangano Report pertains to general releases of radiation from the Oak Ridge Reservation and the health of the nearby citizens. The exercise (evaluation/critique of ANY epidemiological paper) that PHAWG went through during its 08/28/2001 meeting with Lucy Peipins, ATSDR epidemiologist) was meant to provide PHAWG members with a useful tool (i.e., the ability to evaluate basic epidemiological studies they may encounter as they try to perform the Public Health Assessment).

Some people asked if PHAWG had afforded Mr. Mangano any opportunity to respond to criticisms of his report. The consensus was that any paper published in open literature must be able to stand on its own merits. PHAWG did view the videotape where Dr. Gould interviewed Mr. Mangano about the report, and that did not change the Work Group's conclusions about the report.

The full ORRHES Subcommittee was scheduled to hear Part II of Lucy Peipins' Epidemiology Workshop, "Discussion of the Mangano Report," on September 11, 2001. Because of the "Attack on America," her presentation was rescheduled to the upcoming December 2001 ORRHES Meeting. There was discussion regarding whether PHAWG should prepare a Recommendation to the Subcommittee on this topic before or after we have had the opportunity to hear Lucy's presentation.

Amendments to the Al Brooks Resolution:

1. Bob Eklund moved that we amend the Al's resolution to split Item 1) in the second paragraph to put a period after the word "population," then continue with the rest and footnote the last part with a reference. David Johnson seconded. All in favor. None opposed.


2. Kowetha Davidson moved that we amend the resolution to include the following 3 items:
   

• Second paragraph, first line: ". . . the paper was rated low . . ." should be changed to ". . . the paper was inadequate . . ."
• Third paragraph, first line: "the paper also received a low rating in . . ." should be changed to " . . . the paper was also inadequate in . . ."
• Fifth paragraph, second line: ". . . establish that airborne radioactive wastes . . ." should be changed to ". . . establish that radiation exposures . . ."

David Johnson seconded. All in favor. None opposed.

Al Brooks moved that the matrix be added to his resolution as an attachment. Bob Eklund moved to amend Al Brooks' motion, subject to the approval of PHAWG. (Mr. Brooks accepted this.) All in favor. None opposed.

Bill Pardue called for a vote on Al Brooks' main motion with above amendments. Seven (7) PHAWG members voted in favor of the motion, 1 opposed, and 1 abstained. Motion to make a Recommendation to ORRHES passed.

Draft Letter to Dr. Koplan on Scarboro Environmental Sampling

At the 09/11/2001 meeting of ORRHES, a representative of EPA made a presentation on environmental sampling of the Scarboro. Should ORRHES have been involved? Kowetha Davidson feels that ORRHES should be involved because the current sampling effort will expand to Oak Ridge area-wide sampling (not just Scarboro).

Kowetha drafted the letter to Dr. Koplan, but the Copy (cc) List is incomplete. She wants to copy the people at the various agencies that have the authority to act. She asked for and received input about who in the various agencies should be copied on this letter.

Although public participation has indeed occurred over the many years of this effort, everyone feels it is important to find a way for continued public interaction in this process. Although the work now is done within an interagency working group (closed to the public), we would at least like to have an ORRHES member participate in the planning sessions. In this way, we hope to bring more public confidence into the process. Also, ORRHES may invite representatives from this interagency working group to come to ORRHES meetings and update us.

There were several suggestions on how to frame the letter to get the responses we want. Bill Pardue asked Kowetha to edit it and bring a revised draft back to the next PHAWG meeting.

Draft Letter to ATSDR on Secretarial Support

On the positive side, ATSDR did open an office to support the work of ORRHES (something they have not done for any of the other Health Effects Subcommittee sites). We really appreciate having this facility and the support we do receive. However, the level of support is not sufficient if we are to accomplish our mission.

The office should be open to those Subcommittee members willing to spend numerous hours of their personal time working on ORRHES issues. Some Subcommittee members (as well as members of the public who would like to have access to the information in the ATSDR Office) work or have other obligations during the day, and need access to the ATSDR office at night. Bill Murray cannot be there all hours of the day. But if he had full-time secretarial support, that person and Bill could stagger their hours as needed to provide extended office hours for those who need them. Also, the ATSDR Office should create and maintain much better records for ORRHES members and for the public at large. Bill Murray should be afforded sufficient administrative support so that he could provide us ORRHES his technical expertise.

Secretarial support should type major documents, create and maintain files, produce meeting minutes, etc. Additional duties are more clearly defined in the draft letter to ATSDR that Mr. Pardue passed out in the 09/17/2001 meeting. This would make the ATSDR Office and ORRHES function much more effectively.

Bill Pardue made a motion to send this Recommendation to ATSDR. Susan Kaplan seconded.

Discussion:

We need to ask for exactly what we need. A set of "core hours" that the office must be open should be addressed. Reference materials are very important in our work. They need to be available. We've been given the facility - we really need to work with ATSDR to make the best use of it and make it a functioning office. There was discussion about how high in ATSDR's management chain to send this Recommendation. The method of delivery was also discussed (sending a letter in the mail vs. hand-carry the letter and present our case in person). PHAWG is aware of logistical problems for ATSDR in trying to get a method in place to provide office support.

PHAWG members feel that there is a great deal of support of all kinds at the ORRHES level, but the bulk of the work is done at work group level and the individual level. The Oak Ridge ATSDR Office needs to be able to support all work.

Bill Pardue got the sense that everyone likes the idea, but the draft letter needs to be strengthened.

Bill Pardue moved that this draft letter be referred to a small subcommittee to be word smithed. James Lewis seconded the motion. Seven PHAWG members voted in favor of the motion. None against.

PHAWG members interested in volunteering to work on the letter should do that and bring revised draft back to next meeting.

Discussion of Future Direction of the Work Group Activities (Bill Pardue)

Were do we go from here? There are several issues we need to address. Bill Pardue wants honest and free conversation and ideas about these topics:

• What is function of this Committee?
• Are we rubber-stamping ATSDR's plans or are we having input?
• We have been told by ATSDR that they will not deviate from their long-standing process of developing a Public Health Assessment (PHA).
• If we have sincere concerns, do we have ability to change or question? Most of the group feels we should have original input.
• Is the issue about Confidence Levels already decided?

Bill Pardue had this discussion with ATSDR people recently, and they said they're not going to change their process (for developing a PHA). **?[There is a CIRCLA process of superfund sites that this community has substantially changed for the better.]?** If we're not going to be listened to, why bother?

We need an extremely well thought-out Mission Statement for the Work Group. Are we going to look at additive sources: ORR impacts on the world, or impacts of other sites on the world?

Do we look only at health effects (what PHAs are about) or are we looking at probable cause? Are we trying to address public health issues, or are we laying out the basis for lawsuits?

Free and Open Discussion:

Bob Eklund's comment on rubber stamping: The Work Group should put forth a very good Recommendation and see whether or not ORRHES adopts it.

Kowetha Davidson: As chair of ORRHES, she does not think the Subcommittee should consider itself a rubber stamp of ATSDR. High-caliber work should be done by the Subcommittee such that ATSDR cannot ignore our Recommendations. They have to respond (by law). The ATSDR has a process in place to do this work; but that should not be an influence on what Recommendations the Subcommittee provides.

James Lewis: We are an advisory committee; ATSDR can do what they want. Some in ATSDR listen and work with us; others have canned processes. They are required to give us response.

Susan Kaplan has never seen Recommendations from other Subcommittees to be able to determine whether ATSDR utilized them or whether they were blown off. Jack Hanley said he provided that information in the 2^nd or 3^rd ORRHES meeting, but he will provide another copy.

Al Brooks: We as ORRHES members have to express what we believe. How much we can modify certain things is open to question. Public Health Assessments do follow a certain procedure; it's unavoidable. ATSDR has outlined a procedure to deal with ALL contaminants of concern. We had input. We have to make a case for what we consider to be appropriate parameters to be used. We have to present logical arguments. If they reject our reasoning, they must explain why.

Bill Pardue: What do we do beyond the Public Health Assessment? ATSDR does not run clinics. We'll hear from a presentation from someone talking about setting up clinics at one of the future ORRHES meetings. If we recommend that, it could go to Congress; they'll have to change the Charter of some agencies. Again, we are ADVISORY - they don't have to accept any of our Recommendations.

James Lewis: Oak Ridge is different from other DOE sites. We have a field office. We have a different process. Will ATSDR utilize the talent they have here?

Jackie Kittrell: What is reaction of ORRHES to PHAWG's work? Do they rubber-stamp our work? Consensus: ORRHES is required by FACA to discuss Recommendations. A lot depends also on how effective the presentation is to the full Subcommittee. Also, there are some ?internal alliances? within the Subcommittee that influences votes as well.

Al Brooks said ORRHES was set up so that work group members do all the work.

Susan Kaplan: There was never a project plan or flow chart for any other Subcommittee.

Bob Eklund: How interactive have we been when ATSDR needs us to work with them? If we want them to interact with us, we should interact with them.

Al Brooks : They come in with experts that are no more expert than some of us.

James Lewis has been generally impressed with the quality of the presentations by experts at ORRHES Meetings. Examples: Lucy Peipins and Michael Grayson have given presentations to both the full Subcommittee and our Work Group. As presenters, Charlie Miller and Lucy Peipins especially broke down very technical information to layman's level.

Kowetha Davidson: We now have to extract the information that we can use from all those presentations. If there are additional questions, we need to get those answers. Now we need to use the information we've been given

Jack Hanley: If you look at the flowchart, Phase II, we (ATSDR) presented information about iodine. Any outstanding issues and concerns should be fed back to us through the Subcommittee. We're open to hear issues. We know the Work Group has outstanding issues on iodine. Those were outlined those a few meetings ago. Please provide a little more feedback. The same thing applies on screening of past exposures that the State conducted. There has to be more give and take. Communication issues need to be ironed out. This whole process is totally new. Typically a report is written, we put it out for comment for 2 months, and that's it.

Michael Grayson, on the other hand, does not believe what they are doing in Oak Ridge, in terms of involving the community, is extremely new. But at other sites, public gives input which is not extremely substantive. He understands Bill Pardue's comment on rubber-stamping. At Oak Ridge, he got down to community members' level walked them through the process; he also met with some of the PHAWG members individually. Some people in ATSDR had problems with our concerns. He sent some of that information back to PHAWG, but we didn't see it. He sent it to Bill Pardue to refine and send out to the Work Group members. LaFreda advised Michael not to send the information to the rest of the Work Group without Bill first having ?blessed it.? There was some apparent miscommunication because Bill did not realize he was supposed to do that. The Work Group and Bill Pardue asked Michael to send this information directly to the entire Work Group.

Michael Grayson stated the ?doses are already calculated? (using the ATSDR Public Health Assessment Guidance Document, or the ?big blue book?). ?We have to decide how to use them.?

There was another discussion specifically about Confidence Intervals. Some very technical information on the topic was faxed to Bill Murray today, but it is not good reading for the average person.

Michael Grayson wants PHAWG to make him a list of things we want to know about uncertainty analysis. Does PHAWG want ATSDR to use a certain percentile? Grayson's focus is: ?what does the outcome mean??

Brooks: Grayson has the list of PHAWG's concerns about I-131, but the list has not been prioritized.. We owe him a Recommendation in writing.

James Lewis: As a lay person, I have weaknesses in trying to understand this issue. Somebody out there has had experience giving understanding to lay people on uncertainty analysis. We need to find the right presenter.

Bill Pardue: There's an argument that can be made that we don't need to do much at all about uncertainty analysis. Owen and other who have looked at health effects from RaLa project estimate 20 to 30 probable cancers. If other factors are added, we would estimate an additional 20 to 30 cancers. A total of 100-120 cancers over 70-year period is likely. We may accept 100. We might make suggestion that any female of a certain age who drank backyard cows milk go to her doctor and be screened for thyroid disease. Use the worst-case scenario.

Al Brooks: Public will interpret that differently. If that's the approach, we may indeed be laying foundations for lawsuits.

Bill Pardue: Owen Hoffman said no matter what percentile is used, it would not dramatically change number of health effects. We could vary between two extremes and see what come up with. Or we could vary between the central value and the maximum.

Kowetha Davidson: In toxicology, we learn to keep the range reasonable. She advises keeping it between central and maximum.

There is a lot of interest in non-cancerous health effects (e.g., thyroid disease). Michael has a National Academy of Sciences document on the range where the threshold takes place (cancerous vs. non-cancerous health effects), and he wants to go over that information with the Work Group.

Charlie Miller said at the ORRHES Meeting that if he had a daughter that fit most of the categories of concern (time period, geographic area, drank backyard cow or goat milk, etc.), he would make sure she were periodically checked by her doctor.

Bob Eklund reiterated that whatever we decide on as numbers, that's not as important as knowing you fall into this category get yourself checked by your physician. He also commented that the medical community won't respond if there is fear that results would lay blame on the Oak Ridge Reservation.

Jack Hanley followed up by saying that ATSDR can have experts come in and inform doctors how they might better identify people who fall into potential risk categories based on what they may have been exposed to in certain populations, certain years, etc.

L.C. Manley said we should be careful not to infer (again) that Oak Ridge physicians are afraid to diagnose diseases correctly for fear of reprisal. Those accusations have been made before, and were not substantiated.

David Johnson: Everyone can't afford the medicine they need (but we are not in a position to do anything about some issues - like this one).

There was some further discussion about medical treatment in general, the part insurance/HMOs play, particulars such as PACE's state-of-the-art Catscan in a trailer, etc.

Bill Pardue: It's getting late and we need to adjourn. The main thrust of our next meeting will be to prioritize those 10 bullets from 2 meetings ago. Pardue will put together items for the next agenda.

The meeting was adjourned at ~8:45 p.m.