The MDCH and ATSDR are pleased to provide our consensus process comments on the "Michigan Dioxin Exposure Study." We encourage UM and Dow to consider accepting these comments to enable a collaborative approach between UM, MDCH, NCEH/ATSDR Dow, and the affected community. NCEH/ATSDR and MDCH will separately provide our initial technical comments on the proposal by March 12, 2004.

1) Science Advisory Panel (SAP)

A SAP should be developed to provide expert advice on the conduct of any exposure investigations in Midland and Saginaw Counties. Dow should provide funds for the SAP. However, MDCH/ATSDR are concerned that there may be perceived conflicts of interest if the UM, under contract with Dow, retains oversight of the SAP. We therefore recommend that:

• Dow should provide funding to the Michigan Public Health Institute (MPHI) to facilitate recruitment, review, selection, and retention of participants in the SAP. MPHI will also be responsible for facilitation of SAP meetings, correspondence, reports and other activities. MPHI has been approached by the MDCH and is willing to serve in this capacity.
• The 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 SAP.
• MPHI will facilitate the development of selection criteria prior to any nominations based on independence and scientific expertise. Individuals selected for the SAP should be independent and free of any conflicts of interest or financial ties to the Dow Chemical Company.
• Various stakeholder groups (e.g., Dow, UM, the involved State of Michigan agencies, NCEH/ATSDR, local Health Departments, environmental groups, and private citizens) and professional organizations (e.g., The International Society for Environmental Epidemiology, the International Society for Exposure Assessment) will be consulted to make nominations for the SAP.
• SAP meetings should be open to the public and held in Michigan.
• Ex officio (non-voting) members should include NCEH/ATSDR, UM, MDCH, MDEQ
• The SAP should convene to comment and approve: 1) the study protocol; 2) the analysis plan prior to data analysis; 3) provide needed expert advice while the study is on-going; and, 4) review study reports before they are made final and released to the public.
• A liaison from the SAP to the Community Advisory Panel (CAP) should be identified. The liaison will attend CAP meetings, will communicate SAP findings and reports, and will convey technical questions and answers between the CAP and the SAP.

2) Independent Data Center

To ensure that study results will be secure and maintained confidential, MDCH/ATSDR recommend that a Data Center separate from UM or Dow, be established.

• Dow should provide funding to the MPHI to develop (or contract with) a qualified data

• The data center will collect, archive, collate, prepare, and release data sets for analyses.
• Data collected by UM from questionnaires will be sent to the data center.
• Data from environmental samples and blood collection will be sent directly from laboratories to the data center.
• UM will be provided with all data, however the original files will be maintained by MPHI for reanalysis if questions arise concerning data results.

3) Certificate of Confidentiality

To assure the protection of individuals who participate in the UM study, we recommend that the UM Study Principal Investigator(s) apply to the Secretary of HHS for a Certificate of Confidentiality. Such a Certificate would prevent the compelled disclosure of the study subjects’ identities through any "Federal, state, or local civil, criminal, administrative, legislative, or other proceedings", for example through subpoena. Such Certificates are issued when the data collected are sensitive and the issuance of the Certificate would likely increase study participation. See http://grants.nih.gov/grants/policy/coc/ for further information.

4) Comparison of UM results with MDCH’s Pilot Exposure Investigation (PEI)

MDCH/ATSDR strongly recommend against any statistical comparisons of data obtained from the PEI with results of any phase of the UM study proposal. Comparison of the PEI to the results obtained from people who live in Midland and Saginaw counties, but outside the flood plain, will not yield informative data to help interpret the levels found by MDCH in the PEI. UM should make comparisons across the data sets it collects for the populations included in its phased approach.

In order to augment the available background data, MDCH/ATSDR recommend that testing on the population living outside Midland and Saginaw counties be collected as the first phase of the proposed UM study. These control data could be useful to interpret each of the 25 flood plain residents dioxin body burden in relationship to serum dioxin levels in people with no known exposure beyond "background." This comparison would benefit the individual and not make a statement for the group or community as a whole. 

 5) Community Advisory Panel (CAP)

The UM has indicated they will form a CAP and will choose its membership based on independence, representation of community groups, and stature and respect in the community. MDCH/ATSDR are concerned that there will be a perceived bias in choosing the members of the CAP. We recommend that a CAP be formed under the oversight of the MPHI to ensure meaningful participation of the community and reduce any perceived bias.

• Dow should fund the CAP through the MPHI.
• The CAP should meet prior to the first field investigations.
• The CAP should include a liaison from both the UM and the SAP. The liaisons will be ex officio (non-voting) members of the CAP. The liaisons will attend CAP meetings, and will convey reports, findings, comments, and technical questions and answers between the CAP, SAP and the UM.
• Ex officio (non-voting) members should include the SAP liaison, NCEH/ATSDR, UM, MDCH, MDEQ.
• The CAP should review and provide comment on study reports and will convey study information back to the larger community.

6) Communications Plan

MDCH/ATSDR recommend that a communications plan be developed to ensure that information conveyed to the public (e.g., press releases, op ed pieces, and other mass media communications) is accurate and timely. The plan will also ensure that Dow, the UM, the MDCH, the ATSDR, and the local health departments are made aware of developing events so that they can better serve the public.

• Dow should provide funding to the MPHI to facilitate communications.
• Dow, UM, MDCH, NDEH/ATSDR, and the local health departments of the affected communities will be invited to participate on a communications working group.
• Press releases, op ed pieces, or any other information that will be submitted for publication in mass media outlets including newspapers, and radio or television, should be conveyed first to the MPHI facilitator.
• The MPHI facilitator will distribute the information via the working group and will request comments in a timely manner. The facilitator will convey comments to the originator of information.