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:
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.
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.
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.