Document 0Lybzk6G8qQELYYo8oKqk6Q2R

Taft/ Taft Stettinius & Hollister LLP 425 Walnut Street, Suite 18 0 0 / Cincinnati, OH 45202-3957 / Tel: 51 3.38 1.28 38 / Fax: 51 3.38 1.02 05/ www.taftlaw.com Cincinnati / Cleveland / Columbus / Dayton / Indianapolis / Northern Kentucky / Phoenix / Beijing Robert A. Bilott 513.357.9638 bilott@taftlaw. com f y I - o y * \ - odors' 4L3-7.Q -3W 2. March 20, 2009 CD CO TSCA Confidential Business Information Center (7407M) EPA East - Room 6428, Attn: Section 8(e) & FYI U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460-0001 Re: Submission To TSCA 8(e)/FYI Database Re: PFOA/PFOS To TSCA 8(e)/FYI Database: W e are hereby providing the following information for inclusion in the TSCA 8(e)/ FYI databases with respect to PFOA/PFOS: 1. C-8 Science Panel, "Status Report: PFOA and immune biomarkers in adults exposed to PFOA in drinking water in the mid Ohio valley" (March 16, 2009). RAB:mdm Enclosure 11361977.1 Robert A. Bilott III h Contains No CBI CONIMNSNOCBI \lV S \0 0 4 P-2 P-3 t Status Report: PFOA and immune biomarkers in adults exposed to PFOA in drinking water in the mid Ohio valley March 16 C8 Science Panel (Tony Fletcher, Kyle Steenland, David Savitz) This status report summarises the relationship between C8 and several markers of immune status and inflammation in the mid Ohio population exposed to PFOA and studied by the C8 Science Panel as part of its court appointed role. 1 P-4 Status Report: PFOA and immune biomarkers in adults exposed to PFOA in drinking water in the mid Ohio valley Background Perfluorooctanoic acid (PFOA, also known as C8) is a fluorinated compound which is used in several industrial and commercial applications. It is, persistent and ubiquitous in environmental and biological samples. In laboratory toxicity studies, PFOA has been shown to cause damage to the immune system in mice. There is very little information on immune status in relation to PFOA in humans. PFOA has been used in the manufacturing of several chemicals at a chemical plant in Washington, West Virginia since 1951. A survey in a group of residents from the Ohio and West Virginia communities in the vicinity of the plant was conducted in 2005-2006: the C8 Health Project. The current study is an analysis of immune markers in the blood from adults included in that survey. Methods Analyses were carried out on information gathered for 56,315 participants 18 years and older who participated in the C8 Health Project. They had been selected if they had consumed drinking water for at least one year from sources in areas documented to have PFOA contamination. Information on demographic, personal characteristics such as height weight and smoking habits, was collected by questionnaire. Serum was collected and analysed for PFOA and a range of immune markers, including immunoglobulin of several types ( IgG, IgM, IgA, and lgE), total antinuclear antibodies (ANA) and C reactive protein (CRP). Suppression of the immune system can lead to increased susceptibility to disease and a decrease in immunoglobulins can provide an indication o f immune-suppression. For example, a reduction in IgA might be expected to be linked to an increase in upper 2 P-5 respiratory infections. ANA are antibodies which when increased may indicate an increase in the risk of autoimmune diseases. CRP is a marker of inflammation which can be caused by many diseases, a reduction of CRP may indicates an weakness or inhibition o f inflammatory response. Statistical analyses were conducted, to investigate if there was an association between PFOA and these immune markerss, by multivariate statistical models relating the immune marker (after log transformation) to PFOA, with adjustment for age, smoking behaviour, alcohol use, body mass index and ethnic group. Males and females were assessed separately. Results PFOA levels were, as has already been reported for this population, much higher than normal background levels. The range of values for immunoglobulins, ANA, and CPR ranges were largely within normal reference ranges. Several statistically significant associations between levels of immunoglobulins and C8 were found: For IgA the pattern o f association indicated a significant decreasing trend with increasing PFOA; this was also apparent for IgE but only in females. For IgG there was not a consistent trend with PFOA. ANA shows a positive significant relationship with increasing PFOA. CRP showed a strong downward trend with increasing PFOA. Discussion The associations found between this immune biomarkers and PFOA do not necessarily indicate that PFOA is the cause of changes observed. These are cross sectional data with exposure and immune biomarker measured at the same point in time, so we recommend caution in interpretation: one cannot be sure of the time relationships o f changing PFOA concentrations and immunoglobulin levels. Furthermore the magnitude of the changes across the observed exposure range is small and most values remain within normal 3 P-6 ranges. Nonetheless several o f these immune markers show a pattern o f decrease (immunoglobulins A and E, and CRP) or in the case o f ANA an increase, with higher blood levels o f PFOA, suggesting that there may be a relation between immune function and PFOA exposure in exposed persons While this cannot be directly interpreted as indicating an increase in disease risk in this population, it warrants further investigation. Further ongoing work by the Science Panel, will address directly the relationships between PFOA (measured or estimated before disease onset) and some more sensitive indicators o f disturbance in immune function, and the incidence o f diseases whose risks are sensitive to immune-suppression. These include infectious disease, asthma auto immune disease and rheumatoid arthritis. 4