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Results to Date from the PFOA Worker Health Study
January 11,2005
Paul J. Bossert, Jr., Plant Manager Robert W. Rickard, Ph.D., Science Director
of Haskell Laboratory for Health and Environmental Sciences
Sol E. Sax, M.D., Chief Medical Officer
E X H IB IT 1
Results to Date from the PFOA Worker Health 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
Summary
To date, there are no human health effects known to be caused by PFOA; several statistical observations merit further study.
Statistically significant associations are seen with serum PFOA levels and some serum lipid fractions, uric acid, and iron.
These associations were only seen in those study participants with the highest serum PFOA levels, which were equal to or greater than 1000 ppb.
DuPont, in collaboration with outside experts, is committed to conducting the studies that are necessary to understand the significance of these observations.
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Purpose of Study
Phase 1 Cross- Sectional Survey:
Determine if there is a relationship of serum PFOA levels in current employees with respect to medical test results
Phase 2 Historical Mortality Study:
Determine if there is a relationship of past exposures to PFOA and any changes in frequencies and causes of mortality
General Methods-- Phase 1 Cross-Sectional Survey
Voluntary participation across all areas of the plant
Cross-sectional design, that is, "snapshot" of both the exposure marker and the health outcome variables based on complete physical exam and clinical chemistries
Exposure groups, by deciles, used to compare lowest to highest groups based on serum PFOA levels
Statistical analyses for modeling relationships
Status-- Phase 1 Cross-Sectional Survey
1,024 employees participated in the cross-sectional health survey
All participants have received their individual serum PFOA levels and medical test results.
About 60 parameters have been analyzed to date.
Not all of the questionnaire data have been analyzed, but these analyses are underway.
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General Methods-- Phase 2 Historical Mortality Study
Historical study of all causes of death among employees of Washington Works employees
Covers period of about 50 years Compares frequencies and causes to U.S. national rates,
West Virginia populations and the rest of U.S. DuPont Takes into account estimates of past exposures to PFOA
Study is in progress.
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Serum PFOA Levels By Work Assignment
W ork Assignm ent Works in PFOA areas Previously worked in PFOA areas
Number in Group
259
Serum PFOA (ppb)
Median
Min
Max
490 17
9550
264 200 9
2590
Occasionally works in PFOA areas
160
Never assigned to PFOA areas
342
180 8 110 5
2070 963
Total Participants 1025
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General Findings
Nearly all of the parameters measured were within normal reference ranges and not associated with serum PFOA levels:
- No correlation with liver function tests - No correlation with blood counts - No correlation with any cancer markers m easured-
prostate, leukemia, multiple myeloma
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General Findings
Statistically significant but modest increases in some cholesterol fractions (total, LDL) and triglycerides at the highest concentrations of serum PFOA.
Statistically significant but modest increases in uric acid and iron at the highest concentrations of serum PFOA.
Notably, "good" cholesterol (HDL) was unaffected by serum PFOA levels.
CRP levels (C-reactive protein, a possible risk factor for heart disease) were unaffected by serum PFOA levels.
Mean adjusted lipid values for serum PFOA levels indicate a modest increase in highest decile (>1000 ppb)
C H O LJO TA L by PFQA Quantile
Sex=M, H eartm eds=N , UU 2004
Mean
1381823
Std Dev 32.345
350 "
187.0 28.787
205.623 39.434
199867 31099
6 .3 0 6 37.476
204835 32.836
200.871 30.472
199873 31022
206.097 36.740
214587 36.646
300
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250 *
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LOG Chd Total vs LOGPFOA : WW 2004, Terms = LogPFOA ALC6
Where Sex=M, H eartm eds=8
5.8:
SLOPE P-VALUE=0
5 . 7 : R--SQR=0.02
5.G: 5.5:
Total Cholesterol = 240mg/dl
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4 . 8 j 10thdecile of serum PFOA >1000 ppb
4 . 7 i r i--I--i--I--I--i--I j i--i--i--I--I--I--I--r~i--I--I--I--I--r--f--I--j--I--I--I--I--I--I--I--I--I--i--j--I--j--n --i--i--i--rnr--r*i--|--i--r --i--I--j--I--I--I--i--I--I--I--i--I--I--r 3 4 5 G7 8
LOG PFOA
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Overall Comparison of Male Washington Works Study Participants with the General US Population
30
25
Percentage of U.S. men, 20-70 years 20 .........of age, with total serum cholesterol............
levels greater than 240 mg/dL: 17 .8%
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Summary
To date, there are no human health effects known to be caused by PFOA; several statistical observations merit further study.
Statistically significant associations are seen with serum PFOA levels and some serum lipid fractions, uric acid, and iron.
These associations were only seen in those study participants with the highest serum PFOA levels, which were equal to or greater than 1000 ppb.
DuPont, in collaboration with outside experts, is committed to conducting the studies that are necessary to understand the significance of these observations.
Plans for Further Work
DuPont Medical, Epidemiology and Toxicology will work with medical and other scientific experts to design studies to answer remaining questions: Are these observations reproducible? Are similar associations seen in other worker populations? Is there a cause and effect? Is there a biological basis for these associations?
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Implications of Study Beyond Plant
Not a general public health issue:
Associations were only seen in an occupational setting. PFOA levels in general public extremely low.
Not a consumer health issue:
- DuPont research has demonstrated that no detectable serum PFOA levels would result from the use of consumer articles made with DuPont products
2004 Progress Report Reduction of C8 Emissions
& Discharges at DuPont Washington Works
<30
Emissions Reduction
2004 Progress Report Reduction of C8 Emissions & Discharges at
DuPont Washington Works
..1999 I 2004 YE IReduction IJ
Air Water
jSwaWKaw^s35jwsuesi15waMcwS25Kr^iWM09waf^M9f7.vmKa^I!
185 1542
I 99.4% I 97.2%
Total 86806 1 1727 111 98.0% 1
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Emissions and Exposure Reduction
More than $21.5 million invested since 1988; another $6.2 million planned by 2006.
DuPont is making recovery/recycle technology available to competitors.
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Results to Date from the PFOA Worker Health Study
January 11,2005
Questions and Answers
Paul J. Bossert, Jr., Plant Manager
Robert W. Rickard, Ph.D., Science Director
of Haskell Laboratories for Health and Environmental Sciences
Sol E. Sax, MD, Chief Medical Officer
Mean Std Dev
2.50 -
2.25
1736 0.198
URIC_ACID b y PFOA Quantile
Sex=M, H eartm eds=B , UU 2004
1755 0209
1.822 0.179
1828 0.183
1820 0177
1.805 0.189
1810 0.205
18* 0205
1.777 0 *0
1.875 0.178
2.00 i
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11
150 125
100 -----!--------------- 1---------------- 1----------------1----------------1---------------- 1----------------1----------------1----------------1
i
W 18
W2 67
W3 97
W4 133 W 5 J 6 9 W6 210 W7 _266 W8 967 W9 537 W10 1040
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Mean Std Dev
1410 0213
URIC_ACID b y PFOA Quantile
Sex=F, Heartmeds=B, UU 2004
1.314 0.309
1495 0.285
1486 0.287
1542 0.195
1.533 0.192
1568 0.275
1552 0.242
Mean
1.508
Nobs 243.000
1.594 0.175
1.582 0.222
LO G LI RIC_AQ D vs LO G PFO A : W W 2004, Terms= LogPFOA BMI ALC4
Where Sex=M, Heartmeds=B
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SLOPE P--VALUE= 0
2.5
R--SQR= 0.16
2.4
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1.7
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r j i l- - | l -|- l- l ! i- j- i ,... , , , -, -, i i i i i' [ m
3 .5 4 .0 4 .5 5 .0 5 .5 G.O
'T 'i i i i i | i i i i [ r i i i ) i i r r f r r i i ') i i "i r
G .5 7 .0 7 .5 8 .0 8 .5 9 .0 9 .5
LOG PFOA