Document 70Rd8ZyadyQMzj7v2Q8ygjYp6

BACK TO MAIN 3M Company EPI-0015 Page I of 6 FINAL REPORT Epidemiology, 220-3W-05 Medical Department 3M Company St. Paul, MN 55144 Date: March 19,2001 Title: Descriptive Summary of Serum Fluorochemical Levels among 236 Building Employees Study Start Date: September 20,2000 IRB Approval Date: (not applicable) Protocol Number EPI-0015 IRB Approval Exempt Expedited X Principal Investigator: Geary W. Olsen, D.V.M., Ph.D.' Co-investigators Study Director: Diane C. Madsen, M..A.' Jean M. Burris, R.N., M.P.H.' Jeffrey H. Mandel, M.D., M.P.H.' Jeffrey H. Mandel, M.D., M.P.H. * 1. 3M Medical Department, 220-3W-05, St. Paul, MN 55144-1000 Page I BACK TO MAIN ABSTRACT 3M Company EPI-OO 15 Page 2 of 6 Through communicationefforts by their supervisorsand Corporate Occupational Medicine, Building 236 employees engaged in fluorochemical research and Specialty Materials Markets Division (SMMD) Environmental Health Safety and Regulatory (EHSR) activities were offered the voluntary opportunityto have their blood tested for seven fluorochemicals.A total of 45 employees participated. Geometric mean serum levels for perfluorooctanesulfonate (PFOS), perfluorooctanoate (PFOA) and , perfluorohexanesulfonate(PFHS) were (95% confidenceinterval in parenthesis): 0.116 ppm (0.008-0.152);0.053 ppm (0.027-0.076);and 0.018 ppm (0.013-0.024). The majority of the employees tested for the remaining four fluorochemicalshad values that were below the lower limit of quantitation. Page 2 BACK TO MAIN INTRODUCTION 3M Company EPI-00 15 Page 3 of 6 Through communication efforts by their supervisorsand Corporate Occupational Medicine, Building 236 employeesengaged in fluorochemical research and Specialty Materials Markets Division (SMMD) Environmental Health Safety and Regulatory (EHSR) activities were offered the voluntary opportunity to have their blood tested for seven fluorochemicals. Met hods Blood collection was performed by a medical technician (DCM) in Building 236 on September20,22 and October4,2000. A signed consent form was required from each participating employee. A total of 45 employeesparticipated. Accordmg to human resource records, the 45 employeeswere assigned to several SpecialtyMaterials ManufacturingDivision laboratoriesincluding: Internal Chemicals (Specialty Coatings Group), Analytical (Methods Group, Physical Properties Group), Commercial Process TechnologyDevelopment (TechnologyDevelopment,Process Development and Factory Support),Process DevelopmentInternal Chemicals and the FluorochemicalMaterials Research Group. Also tested were some employeesfrom the ChemicalEHSR function. Sera samples were extracted using an ion-pairing extraction procedure. The extracts were quantitatively analyzedfor PFOS (perfluorooctanesulfonate),PFOA (perfluorooctanoate, which is also known as C8 acid or POAA), PFHS (perlluorohexanesulfonate),PFOSAA (N-ethyl perfluorooctanesulfonamidoacetate), M570 (Naethyl perfluorooctanesulfonamidoacetate), PFOSA (perfluorooctanesulfonateamide)and M556 (peffluorooctanesulfonamidoacetate) using Page 3 BACK TO MAIN 3M Company EPI-0015 Page 4 of 6 high-pressure liquid chromatography/electrospray tandem mass spectrometry (HPLC/ESMSMS)and evaluated versus an extracted curve from human sera. Endogenous levels of certain fluorochemical were determined in the standard matrix and additional fluorochemical was spiked into the matrix. The total amount of each specific fluorochemical (endogenous + spiked) was used to construct an extracted standard curve. All serum fluorochemical analyses were determined by Northwest Bioanaltyical Laboratory Inc. (Salt Lake City, UT). All employee serum values for PFOA and PFHS were above their respective lower limit of quantitations(LLOQ). There was 1employee who was determined to be below the LLOQ for PFOS (0.0368 pprn). There were 34 (76%) employees who were below the LLOQ for PFOSAA (0.0042 ppm); 15 (33%) employees were below the LLOQ for M570 (0.0037 ppm); 43 (96%) employees were below the LLOQ for PFOSA (0.001 ppm) and 40 (89%) employees were below the LLOQ for M556 (0.0038 ppm). Measures of central tendency were not calculated for PFOSAA, M570, PFOSA and M556 because of the many employees who were below the LLOQ. For PFOS, the midpoint between zero and the LLOQ was assigned for the one individual who had a value recorded below the LLOQ (0.037 ppm). Stratified analysis of the data by laboratory departments was likely considered to be non-representative due to the low voluntary participation rates. Therefore, only summary findings are presented for these 45 individuals. Page 4 BACK TO MAIN RESULTS 3M Company EPI-0015 Page 5 of 6 Presented in Table 1 (below) are the summary findings in parts per million (ppm) for the seven fluorochemicals measured. Table 1 Arithmetic Mean, Range, Geometric Mean and 95%Confidence Interval of Serum Fluorochemical Levels, 236 Building Employees (N = 45) PFOS PFOA PFHS PFOSAA M570 PFOSAA M556 Arithmetic Mean bum) 0.182 0.106 0.027 - - Range bDm) ~0.0368-1.036 Geometric Mean (ppm) 0.1 16 0.008-0.668 0.053 0.002-0.103 co.0042-0.010 4.0037-0.195 4 . 0 01-0.001 4.0038-0.052 0.018 - - - 95%Confidence Interval bum) 0.008-0.152 0.037-0.076 0.013-0.024 - DISCUSSION The serum fluorochemical levels of Building 236 laboratory and EHSR employees were, on average, one order of magnitude lower (or more) than those reported fer production workers at Antwerp, Cottage Grove and Decatur. Building 236 laboratory workers may have, on average, 2- to 4-fold higher serum PFOS levels than those reported in the general (non-occupational)population. r' All employees who participated in this voluntary serum fluorochemical examination were sent a letter to their home address which provided their individual Page 5 BACK TO MAIN 3M Company PI-0015 Page 6 of 6 results. Employees were informed that the serum levels observed among Building 236 employees have not been associated with adverse health findings based on medical surveillance exams of 3Ms production employees. Employees were encouraged to discuss their results with a Corporate Occupational Medicine physician (JHM) should they have additional questions. Page 6