The Michigan Dioxin Exposure Study

Transcription

1 The Michigan Dioxin Exposure Study The University of Michigan School of Public Health Institute for Social Research College of Engineering May 10, 2005

2 David Garabrant, MD, MPH Professor of Occupational Medicine and Epidemiology University of Michigan School of Public Health Alfred Franzblau, MD Professor of Occupational Medicine University of Michigan School of Public Health James M. Lepkowski, PhD Senior Research Scientist, Institute for Social Research University of MIchigan Peter Adriaens, PhD Professor, Civil & Environmental Engineering University of Michigan College of Engineering Avery Demond, PhD Professor, Civil & Environmental Engineering University of Michigan College of Engineering Brenda Gillespie, PhD Professor of Biostatistics University of Michigan School of Public Health

3 The University of Michigan Dioxin Exposure Study Goals of this presentation: Present the study background, design, rationale, and schedule. Provide details of the University of Michigan study adequate for you to respond to critical questions. Explain how this study will advance our knowledge of serum dioxin levels in Midland, Saginaw, Jackson, and Calhoun counties, and their sources.

4 The University of Michigan Dioxin Exposure Study The Dow Chemical Company has asked the University of Michigan to design and conduct a study of dioxin exposures in the Midland and Saginaw county area The Univ. of Michigan study will be funded by Dow. The study will be independent. The investigators will not report to Dow. The investigators will report to an independent Scientific Advisory Board (SAB)

5 Dioxin in Midland 1978: Dow Chemical notifies Michigan Department of Community Health that dioxin was found in fish caught from the Tittabawassee River Fish advisory issued 1985: EPA and CDC conclude Midland community soils below federal action standard of 1,000 ppt 1997: Michigan Department of Environmental Quality conducts additional soil testing in Midland Again, levels below federal standard and State action level 2002: State sets new action level of 90 ppt 2003: State issues Dow hazardous waste license requiring handling elevated soil levels in Midland

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8 Recent Controversy : MDEQ and Dow testing reveals properties along the Tittabawassee with soil levels above State standard Properties declared facilities Owners must notify potential purchasers Owners may not spread contamination Law suits filed by several hundred property owners seeking Dow reimbursement for property values, alleging health problems related to dioxins. 2004: City of Midland sponsors public meeting with MDEQ, Dow, Midland County Health Department, others Over 1,500 residents attend; overwhelmingly in favor of no further testing till exposure or health study completed State legislators attempt to cut MDEQ funding

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10 The Questions We Want to Answer Are dioxin levels in blood increased among people who live in the Tittabawassee River flood plain compared to people who live Elsewhere in Midland and Saginaw Counties Elsewhere in Michigan (Jackson/Calhoun counties) What factors explain the variation in serum dioxin levels among the population? Soil dioxins, house dust dioxins Residential proximity to Tittabawassee River Consumption of fish and game Occupations Age, BMI, sex, etc.

11 Study Overview We will collect the following information/samples from each participant: Responses to a 1-hour personal interview Serum (80 ml blood draw) House dust (vacuum filter sample) Soil Blood, house dust, and soil will be analyzed for the WHO 29 list of dioxins, furans, and coplanar PCBs.

12 Study Overview Multiple linear regression will be used to estimate the relationship between serum dioxins (outcome variable) and Soil dioxin concentrations House dust dioxin concentrations Proximity and duration of residence to The Tittabawassee River The Dow facilities in Midland Consumption of fish and game from the Tittabawassee River and floodplain Past occupations Other factors (age, sex, race, diet, etc.)

13 Study Population Random samples of adult residents (and their housing units) from four populations: 175 residents of the Tittabawassee River flood plain (between the Dow facility in Midland and the South Center Road bridge in Saginaw) 175 residents of Census blocks adjacent to the Tittabawassee River flood plain 175 residents of Saginaw County, Midland County, and part of Bay county who do not reside in the flood plains of the Tittabawassee or Saginaw Rivers or the confluence flood plain of the Shiawassee River 175 residents of Jackson and Calhoun counties

14 Tittabawassee River flood plain Other areas of Midland, Saginaw, and Bay counties

15 Jackson and Calhoun counties are demographically similar to Midland and Saginaw counties.

16 Interview Face-to-face interview regarding: Residential history (using event history technique) Activities on the Tittabawassee River, Saginaw River, and Saginaw Bay Activities in the flood plain Work at Dow (self and family) Occupations with exposure to dioxins and PCBs as well as other exposure opportunities Consumption of fish From the Tittabawassee River, Saginaw River, Kalamazoo River, and elsewhere Store bought Consumption of meat Game from the Tittabawassee River, Saginaw River, Kalamazoo River, and elsewhere Store bought

17 Blood Collection and Analyses 80 milliliters of blood will be collected from each respondent at the time of interview Blood samples will be sent to Alta Analytical Laboratory for analysis of the WHO 29 dioxins, furans, and coplanar PCBs

18 What are Dioxins, Furans and PCBs? 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) Dioxins PCBs Furans

19 Congeners and WHO 29 TEF Values Dioxin Congener WHO TEF Value 2,3,7,8-TCDD 1.0 1,2,3,7,8-PnCDD 1.0 1,2,3,4,7,8-HxCDD 0.1 1,2,3,6,7,8-HxCDD 0.1 1,2,3,7,8,9-HxCDD 0.1 1,2,3,4,6,7,8-HpCDD 0.01 OCDD Furan Congener WHO TEF Value 2,3,7,8-TCDF 0.1 1,2,3,7,8-PnCDF ,3,4,7,8-PnCDF 0.5 1,2,3,4,7,8-HxCDF 0.1 1,2,3,6,7,8-HxCDF 0.1 1,2,3,7,8,9-HxCDF 0.1 2,3,4,6,7,8-HxCDF 0.1 1,2,3,4,6,7,8-HpCDF ,2,3,4,7,8,9-HpCDF 0.01 OCDF PCB Congener WHO TEF Value PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB PCB

20 Household Dust Collection and Analyses One indoor household dust sample will be collected from the residence of each respondent using a vacuum collection method All household dust samples will be collected and handled by ENVIRON staff following the protocol developed by the University of Michigan Dioxin Exposure Study team All vacuum samples will be sent to Alta Analytical Laboratory for analysis of the WHO 29 dioxins, furans, and coplanar PCBs

21 Household Dust Collection

22 Soil Collection Soil samples from: around the residence spots where there are soil contact activities the floodplain (if the property is in the floodplain)

23 Soil Collection

24 Soil Collection and Compositing Residence Zone 4 Sampling Stations 3 Cores per Station 3 Strata per Core Soil Contact Zone Up to 2 Sampling Stations 3 Cores per Station 3 Strata per Core Flood Plain Zone 1 Sampling Station 3 Cores per Station 3 Strata per Core Residence Station 4 Residence Station 1 Residence Residence Station 3 Residence Station 2 Soil Contact Station 1 Soil Contact Station 2 Flood Plain Station Compositing Strategy Cores (6 ) are stratified in vegetation, top 1 and bottom 5 Residence zone core strata are composited Soil contact zone strata composited Flood plain zone strata composited

25 Statistical Analysis Analyses will answer the principal hypothesis: Are serum dioxin levels related to soil dioxin levels? These analyses will control for the effects of other factors (age, sex, BMI, fish consumption, meat consumption, residential proximity to Dow, etc.)

26 Communications Plan Communicate with the population of Midland, Saginaw, Jackson, and Calhoun Counties for the purposes of: Soliciting input on their concerns regarding dioxin contamination in their environment Designing a scientific study that will help to address these concerns Providing reliable scientific evidence that is responsive to their concerns Explaining what the scientific evidence means and how it addresses the concerns of the affected population

27 Community Advisory Panel The University of Michigan has formed Community Advisory Panels with membership based on: Independence Representation of community groups Stature and respect in the community The Community Advisory Panels will: Provide feedback to the investigators regarding the concerns of the community Inform the community about the conduct and progress of the study

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29 Scientific Advisory Board The University of Michigan has selected a Scientific Advisory Board, with membership based on: Independence Qualifications in research relevant to the dioxin issues Scientific stature

30 Working Relationships Public SAB CAP University of Michigan Communities

31 Public Perceptions of the Study Independence and integrity are essential to the success of the study The University of Michigan alone has control over the conduct of the study. The University has the right to publish the results of the study as it sees fit. The University researchers will report on the progress, conduct, and results of the study to the SAB. The SAB will report results to the public, including Dow. The Dow Chemical Company has no involvement in the conduct of the study. The University of Michigan has asked ATSDR to audit the data as the study is conducted to assure impartiality.

32 Current Status/Schedule for the UMDES Fall we completed about 40% of the data collection in Midland and Saginaw Counties March Sept Field data collection in Midland/Saginaw Counties We have yet to complete about 60% more (about 315) people with interviews, blood, dust, and soil collections May Sept Field data collection in Jackson/Calhoun Counties Formation of a Community Advisory Panel for Jackson/Calhoun We will complete 175 people with interviews, blood, dust, and soil collections Spring 2005 Winter 2006: All blood, dust and soil will be analyzed for dioxins Fall 2005 Summer 2006: Statistical analyses of data, report writing Fall 2006 Presentation of results to the SAB, then to the community

33 Reporting of Results Individual participants will be given the results of their tests (if they wish to receive them). Aggregate data will be presented in scientific reports which will be peer-reviewed by the SAB. Scientific reports that have been approved by the SAB will be posted to a website which will be publicly available. The investigators will meet with community members to discuss results and answer questions.

34 Communications We set up a toll free telephone number and an address for people to contact us directly with questions Toll Free mdes@umich.edu or umdioxin@umich.edu And we have these magnets for everyone.

35 Communications Our website contain updates and information on the study conduct and progress

36 Website: The website for the UMDES contains: Study protocols Study progress reports/status News about the dioxin situation as it is related to the UMDES Aggregate study results Links to dioxin literature Information for professionals for use in interpreting serum, dust, and soil results.

37 Risks in UMDES Minimal physical risks (e.g., phlebotomy) The major risks are economic, and are related to: Knowledge of dioxins in soil and/or house dust could have negative consequences on property values Knowledge of dioxins in soil and/or house dust could have negative consequences for landlords or other property owners (e.g., condo associations and trailer park owners). Knowledge of levels above the MDEQ standard for soil (90 PPT) may trigger designation as a facility, and other regulatory requirements.

38 Informed Consent Issues Permission to obtain house dust and/or soil samples must be obtained from property owners; consent also will be sought from participants who are non-owner occupants Participants will be given the option of receiving or not receiving their personal test results (blood, house dust and/or soil) if the subject does not have knowledge of soil and house dust results, then there is no economic risk to the subject since the subject would not have knowledge of the results

39 Informed Consent: Authority Measurement/ Ownership Questionnaire & Blood Sample House Dust Soil on Private Property status Owns house & land Sole Consent Sole Consent Sole Consent Owns house, not land (e.g., condo owner) Sole Consent Sole Consent Not collecting samples Does not own house or land (e.g., tenant or adult child of owner) Sole Consent Not collecting samples Not collecting samples

40 Assurance of Confidentiality Usual confidentiality procedures (e.g., do not use names in reports, assign identify codes, keep materials secure, chain of custody of specimens, etc.) Confidentiality pledge to be signed by all investigators and staff Certificate of Confidentiality Based on federal legislation that assures confidentiality in perpetuity (Section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) Issued by NIH ( Protects investigators and institutions from being compelled to release information that could be used to identify research study participants (civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level)

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