David H. Garabrant, M.D., M.P.H.
Professor of Occupational Medicine and Epidemiology
The University of Michigan School of Public Health
1420 Washington Heights, Room 6529
Ann Arbor, Michigan 48109-2029
Mr. John Phillips
Dow Chemical Company
Midland, Michigan 48667
Thank you for participating in the telephone conference call on March 23, 2004, when you and our staff discussed the "process comments" we had provided you on March 10, 2004, regarding the University of Michigan’s proposed study. We hope these continued deliberations will establish a collaborative relationship in which your study provides meaningful information to the affected community, the Michigan Department of Community Health (MDCH), the Agency for Toxic Substances and Disease Registry (ATSDR), Dow Chemical Company (DOW), and the University of Michigan (UM). The primary objective for MDCH and ATSDR is for your study to answer critical questions about dioxin exposure in the affected communities in a manner that is both scientifically rigorous and without any perceived influence from Dow.
The remainder of this letter highlights our current recommendations based on our last conference call, suggests how additional deliberations can be made, and establishes several next steps for moving our collaboration forward.
AREAS OF AGREEMENT:
- Data Center - MDCH and ATSDR concur with the UM responses regarding a separate data management center. We agree that UM is highly capable, and responsible for data management and data security. ATSDR will identify a data auditor who will have access to the data. We recommend that the auditor review how the data files will be blinded so that the analysts will be unaware of the exposure and
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outcome data of individuals. We also recommend that an audit plan be developed with the analysis plan that should be reviewed by the Scientific Advisory Board (SAB).
- Certificate of Confidentiality - MDCH and ATSDR concur with the UM decision to obtain a certificate of confidentiality for this study.
- Communications Plan – as discussed on the conference call, the primary intent of a communications plan is to inform each other, on a timely basis, of activities and communications with the affected community. Specifically, we understand that DOW, UM, and MDCH agree to provide each other with advance notice of press releases and community meetings by either party. By affording one another this courtesy, we will each be able to respond to critical site/study developments in a thoughtful, proactive manner. This should assist us all in providing the best possible service to the community.
AREAS REQUIRING FURTHER DISCUSSION:
- Scientific Advisory Board (SAB)
- MDCH and ATSDR appreciate the offer by the UM to allow ATSDR veto power on members selected by UM to serve on a UM SAB. MDCH and ATSDR are confident that UM is capable of establishing and managing the SAB. However, we understand that members representing the affected community perceive the possibility that the SAB members could be influenced by DOW under such an arrangement. ATSDR and MDCH believe that the SAB should be managed by the Michigan Public Health Institute (MPHI) which will add neutrality and credibility of your work in the eyes of the public. We are seeking a letter of support of this proposal from the Lone Tree Council and the Tittabawassee River Watch. The issue is not whether MPHI is an independent agency, but that the Institute provides a legitimate balance between the interests of the UM and the MDCH. To allay any concerns UM may have about individuals selected for the SAB, MDCH and ATSDR propose that UM have veto power over any nominee.
- Dow should provide funding to MPHI to facilitate recruitment, review, selection, and retention of participants in the SAB. MPHI will also be responsible for facilitation of SAB meetings, correspondence, reports and other activities. MPHI has been approached by MDCH and is willing to serve in this capacity.
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- MDCH will provide oversight for the contract with MPHI. Dow should not be involved with the conduct of the contract beyond provision of funds except to provide nominations to the SAB.
- MPHI will facilitate the development of selection criteria prior to any nominations based on independence and scientific expertise. Individuals selected for the SAB should be independent and free of any conflicts of interest or financial ties to Dow. UM, MDCH, ATSDR, and the affected community should all have the opportunity to nominate SAB members. UM will have veto power over any nominee.
- Comparison of UM study results with MDCH’s Pilot Exposure Investigation (PEI)
- ATSDR/MDCH will not provide UM a data file with the results from the PEI for statistical comparisons with the UM study because such a comparison is inappropriate. The objectives of the PEI are: 1) to provide information on the levels of dioxins in soil, indoor dust, and blood samples for 25 residents of the flood plain, and 2) to test the sampling criteria and methodology prior to the design of a larger representative exposure assessment study. ATSDR/MDCH conducts exposure investigations when data are missing that are needed to determine if the public is exposed to environmental contaminants. Typically, the expected worst-case exposure scenarios are selected as a first cut measure to determine if exposures are occurring. As such, selection of the PEI participants is intentionally biased and not comparable to the random selection proposed by UM.
- ATSDR/MDCH encourage UM to conduct a representative study of persons in Michigan with no known source of dioxin exposure either before or concurrently with studies conducted in Midland and Saginaw counties. These data would help the MDCH interpret the results of the PEI and the proposed studies UM is planning in Midland and Saginaw counties.
- ATSDR/MDCH recommend that residents living on properties in the flood plain of the Tittabawassee River and in other areas of Saginaw and Midland counties outside the flood plain be recognized as a single population rather than two distinct populations and that the UM study sample the entire population in a single phase. As the results of the most recent Michigan Department of Environmental Quality (MDEQ) soil sampling efforts indicate, it is not possible to definitively predict if property is contaminated based on whether it lies within or outside of the flood plain. Detected concentrations of dioxins are not elevated on all properties within the flood plain. We are just beginning to understand the depositional characteristics of the river and other factors that determine if contaminated sediments have been deposited on upland areas.
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- Conversely, properties that were not expected to be impacted have shown elevated soil dioxin concentrations, most likely due to soil movements unrelated to flood waters. Predictions of exposure to soil contamination within the city of Midland based on plume modeling may be similarly difficult. UM is encouraged to view the level of dioxins in soil as the appropriate variable under study, rather than whether or not the property lies within the flood plain or within the predicted area of depositional impact within the city of Midland. This recommendation also permits the UM to make valid within-study comparisons between potential exposure factors and serum dioxin levels.
- ATSDR and MDCH recommend that soil and blood samples from the UM study be analyzed concurrently.
- Community Advisory Panel (CAP)
- Instead of forming a new CAP, MDCH and ATSDR recommend that the current CAP that is chaired by MDEQ be utilized. This current CAP is already ongoing, and is accepted by the community as a group with a broad representation and working history. Using the existing CAP will also eliminate the delay in soliciting community input on the study design. MDCH is willing to propose to the current CAP that its focus be amended to include discussions about the UM study.
- Given that time is short and that we need to conclude these deliberations before your protocol is finalized, we suggest you review our comments and call either Mark Johnson or Alan Yarbrough to arrange a follow-up phone call if necessary.
- UM will finalize its study protocol for submission to the UM Institutional Review Board (IRB) in April 2004.
- UM will provide MDCH and ATSDR with a copy of the final study protocol for review.
- The SAB will be established and review the final study protocol.
- UM will respond to review comments, make needed chances, and resubmit if necessary to the UM IRB.
- Once MDCH and ATSDR have reached a process agreement with UM and the representatives of the affected communities indicate their acceptance, UM may
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negotiate the analysis of serum dioxin samples with the Division of Laboratory Sciences, National Center for Environmental Health.
We look forward to a copy of the draft protocol in April 2004. If we can be of any further assistance, please do not hesitate to contact us.
Michigan Department of Community Health
Henry Falk, M.D., M.P.H.
Director, National Center for Environmental
Health/Agency for Toxic Substances and
Rear Admiral, U.S.P.H.S. (Retired)
Peter Adriaens, UM
Grant Baldwin, ATSDR
Matthew Boulton, MDCH
Brendan Boyle, MDCH
Lorri Cameron, MDCH
Mike Carson, Dow
Jim Collins, Dow
Linda Dykema, MDCH
Tracey Easthope, Ecology Center
Roberta Erlwein, ATSDR
Al Franzblau, UM
Tina Forrester, ATSDR
Brenda Gillespie, UM
Rick Gillig, ATSDR
Alden Henderson, ATSDR
Libby Howze, ATSDR
Michelle Hurd-Riddick, Lone Tree Council
Mark Johnson, ATSDR
Mike Krecek, Midland County Health Dept.
Robin Lee, ATSDR
Deborah Mackenzie-Taylor, MDEQ
Susan Metcalf, ATSDR
Larry Needham, ATSDR
Tom Sinks, ATSDR
Neil D. Varner, Saginaw County Health Dept.
David Wade, MDCH
Richard Weston, ATSDR
Sharon Williams-Fleetwood, ATSDR
Krishna Winfrey, UM
Lynn Zwica, UM
Word Doc: MDCHATSDRresponsecoverletter0408041.doc