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DuPont Haskell Laboratory for Health and Environmental Sciences Elkton Road, P .O . Box 5 0 Newark, DE 19714-0050
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Via Federal Express
Document Processing Center (Mail Code 7407M)
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Attention : 8(e) Coordinator e al Office of Pollution Prevention and Toxic s
U .S . Environmental Protection Agency
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1201 Constitution Ave ., NW
Washington, DC 20460 a ~ ~
Dear 8(e) Coordinator :
8EHQ-03 81-03 94 Perfluorooctanoate (PFOA) Phase I Study Supplement
This letter is submitted as a supplement to our January 10, 2005 and August 4, 2005 submissions to the above-identified file . These submissions specifically pertain to an ongoing study referenced as "Ammonium Perfluorooctanoate : Cross-Sectional Surveillance Of Clinical Measures of General Health Status Related to a Serum Biomarker of Exposure and Retrospective Cohort Mortality Analyses in a Polymer Production Plant", which involves over 1,000 employees at the DuPont Washington Works, West Virginia plant.
In the January 10, 2005 letter, we reported on our analysis, to date, of the comparison between serum PFOA level results and blood/urine medical analysis results . At the time of the submission, data analysis was not complete and analysis of over 60 parameters was in progress . This additional data analysis has been completed and this submission supplements information previously reported with respect to this study .
As a result of the additional analysis, it was noted that serum PFOA was positively associated with serum lactate dehydrogenase (LDH), calcium and potassium ; however, the magnitude of the effect indicated that they are unlikely to have any clinical significance . In males, estradiol and testosterone were also positively associated with serum PFOA . However, it is difficult to interpret this positive association because various factors were not considered . For example, reproductive hormone levels are known to have circadian variations, and this factor was not taken into consideration when these hormones were analyzed since blood draws occurred at varying times of the day based on workers' shifts and free periods, and times of sampling were recorded for some but not all participants .
While DuPont does not believe this information is substantial risk information reportable under TSCA 8(e), DuPont is submitting the information to the TSCA 8(e) office in view of the Agency's continued interest in perfluorinated substances .
Sinc ely ,
A . Michael Kaplan, Ph . .
AMK/RWR/RCL : clp (302) 366-5260
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TSCA 8(e) Submission : 8EHQ-0381-039 4 Per fl uorooctanoate Washington Works Phase I
bcc : L .J . Fisher M .L . Rees A .V . Malinowski D . Chas e A .M . Kaplan R .W . Rickard K .K . McCord D .W . Boothe S .E . Sax S .J . DeCarli G .L . Kennedy R .C . Leonard C .J . Sakr Technical Fil e
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