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3M
Larry R. Zobel, MD, MPH ' Staff Vice President and MedicaJ Director
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3M Center, Building 0220-02-E-02 PO Box 33220 St. Paul, MN 55133-3220 651 733 5181 Office 651 733 5152 Fax
March 19, 2002
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2002 APR 16 PH 2:21
Document Processing Center (7407) ATTN: Section 8(e) Coordinator Office of Pollution, Prevention and Toxics US Environmental Protection Agency 401 M Street, SW Washington, D.C. 20460
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Re: TSCA 8(e) Supplemental Notice for Sulfonate-based and Carboxylic-based Fluorochemicals - Docket Numbers 8EHQ-1180-373; 8EHQ-1180-374; 8EHQ-03810394; 8EHQ-0598-373
Dear Docket Coordinator:
With this letter, 3M is providing final reports and other supplemental information related to previous TSCA Section 8(e) notifications. All of the enclosed items are already in EPA's possession and available in TSCA Docket AR-226. We believe, however, that placing these items in the 8(e) docket may allow for more convenient access to information directly related to previous 8(e) notifications by 3M.
The reports enclosed are as follows:
1. Final Report, Identification of Fluorochemicals in Human Sera. I. American Red Cross Adult Blood Donors, February 25, 2002.
2. Final Report, Identification of Fluorochemicals in Human Sera. II. Elderly Participants of the Adult Changes in Thought Study, Seattle, Washington, February 25, 2002.
3. Final Report, Identification of Fluorochemicals in Human Sera. III. Pediatric Participants in a Group A Streptococci Clinical Trial Investigation, March 15. 2002.
4. Interim Report #2, Determination of Serum Half-Lives of Several Fluorochemicals, January 11. 2002.
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March 19, 2002 Page 2
5. Final Report, A Longitudinal Analysis of Serum Perfluorooctanesulfonate (PFOS) and Perfluorooctanoate (PFOA) in Relation to Clinical Chemistry, Thyroid Hormone, Hematology and Urinalysis Results from Male and Female Employee Participants of the 2000 Antwerp and Decatur Fluorochemical Medical Surveillance Program, October 11, 2001.
6. Final Report, A Longitudinal Analysis of Serum Perfluorooctanesulfonate (PFOS) and Perfluorooctanoate (PFOA) Levels in Relation to Lipid and Hepatic Clinical Chemistry Test Results from Male Employee Participants of the 1994/95, 1997 and 2000 Fluorochemical Medical Surveillance Program, October 11,2001.
In addition, 3M contracted with Dr. David Gaylor of Sciences International, Inc. to calculate benchmark doses for low-dose cancer risk assessment based on the results from the cancer bioassays in rats with N-EtFOSE and PFOS. These two-year bioassay reports were submitted on February 8, 2002. Dr.Gaylor's reports provide values for the lower 95thpercent confidence limit of the benchmark dose (BMDLio) in terms of dietary concentration of N-EtFOSE or PFOS, respective to the test compound used in the study, and serum PFOS concentration, as measured at 14-weeks of dosing.
7. Benchmark Doses for Tumor in Sprague Dawley Rats fed N-Ethyl Perfluorooctanesulfonamido Ethanol (N-EtFOSE), January 31, 2002.
8. Benchmark Doses for Liver Tumors in Sprague Dawley Rats fed Perfluorooctane Sulfonic Acid Potassium Salt (PFOS), January 24, 2002.
Please contact Dr. John Butenhoff., 651-733-1962, or Dr. Geary Olsen, 651-737-8569, for further information on these studies.
Regards,
Larry R. Zobel, MD MPH Staff Vice President & Medical Director
cc: J.L. Butenhoff - 220-2E-02 G.W. O lse n -220-3W-05
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