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AR226-1910 13p Ongoing PFOA Worker Study Ammonium Perfluorooctonoate: Cross-Sectional Surveillance of Clinical Measures of General Health Status Related to a Serum Biomarker of Exposure and Retrospective Cohort Analyses in a Polymer Production Plant 1 What... An occupational health study that uses two approaches-- - Cross-sectional survey of health-related endpoints and a serum biomarker of exposure (PFOA) - Retrospective cohort mortality analyses of all workers at the plant from 1948-2002. Reference populations include U.S. DuPont; U.S. general; Wood Cty, WV; state of WV; and Washington Cty, Ohio 2 Who... ... are the subjects? - 1025 volunteer current active workers (males and females) at the DuPont Washington Works site ... are the investigators? - DuPont Epidemiology Program staff - Haskell Laboratory toxicologists and statisticians, analytical chemists, information services staff - Professional Health Services (occupational clinical services provider) ...provides oversight and review? - Epidemiology Review Board Dr. David Wegman, Chairman - West Virginia Univ. Institutional Review Board Dr. Robert Craig, Chairman 3 Why? Primary objectives : - Develop statistical models that describe the relationship of serum PFOA to health outcome variables suggested by previous animal and worker studies, taking into account potential confounders and effect modifiers. - Conduct retrospective cohort mortality analyses using appropriate stratification based on job/task descriptions and estimated past exposures to PFOA. 4 Why? Secondary objectives: - Develop a statistical model that describes the variability in the biomarker of exposure (serum PFOA) in terms of the traditional occupational epidemiological descriptors, e.g., job, task, duration of work in PFOA areas, etc. in order to stratify historical cohorts by potential exposure to PFOA for mortality analyses. - Identify appropriate markers of effect (if any) to allow proper follow-up through continued improved surveillance. 5 Where... ...is the plant? 6 Where... ...are the laboratories doing the analyses? - Haskell Laboratory, Newark, DE - Professional Health Services, Havertown, PA - Exygen Laboratories, State College, PA - Quest Diagnostics, PA 7 When? Epidemiology Study Timeline Design, identification of contractors, approvals from review boards Operations and logistics planning, employee communications Clinical examinations, blood draw 2004 A MJ J A S pauuue r ynl gp ONDJ c oea t vcn Electronic data capture/transfer/QA Initiate statistical analyses, draft methods, outline results section, meet with ERB Draft Final Report 8 Participation 1,863 letters of invitation sent to all current active DuPont employees at the site (no contractors) 1,147 volunteer forms returned 1,025 workers kept clinical exam appointments 9 Num ber Proportion of Work Areas Volunteering 1200 1000 800 600 400 83% 200 0 63% Teflon Non-Teflon Work Areas Volunteers Total eligible 10 Number of Individuals Distribution of Males, Females among Active Employees 500 400 300 M 200 F 100 0 20- 25- 30- 35- 40- 45- 50- 55- 60- 6524 29 34 39 44 49 54 59 64 69 5-Year Age Groups 11 Number Distribution of 5_year Hire Groups 600 500 400 M 300 200 F 100 0 964 969 974 979 984 989 994 999 004 -1 65-1 70-1 75-1 80-1 85-1 90-1 95-1 00-2 1960 19 19 19 19 19 19 19 20 Years Hired 12 Distribution of Serum PFOA Levels By Current Work Assignment Serum PFOA (ppm) Work Assignment Teflon Number in Group 259 Median 0.494 Min Max 0.0174 9.55 Research/Technical 160 0.176 0.0081 2.07 Never assigned to Teflon Assigned to Teflon at some point Total Participants 342 264 1025 0.114 0.195 0.0046 0.963 0.0086 2.59 13