Document mmNoJg7dZXgoDB8e66b13ad1g

3M General Offices 3M Center St. Paul, MN 55144-1000 612 733 1110 r -frlUZ - 103F September 5, 2001 g & t i-o e o i _ 0 373 OEPA-OTS 000943245R OOOTHaSHSR Document Processing Center (7407) Office o f Toxic Substances U.S. Environmental Protection Agency 401 M Street, SW Washington, DC 20460 Attn: TSCA Section 8(e) Coordinator Dear Section 8(e) Docket Coordinator: Re: TSCA 8(e) Supplemental Notice on Sulfonate-based Fluorochemicals With this letter, 3M is providing final reports and other supplemental information related to previous TSCA Section 8(e) notifications. Many o f the enclosed items are analytical reports providing blood serum and liver levels o f test materials for which the in-life report referring to administered doses has already been submitted to the 8(e) docket. In other cases where the 8(e) notification consisted o f preliminary data, we are submitting a final study report. All o f 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 table below lists the enclosed items and references the study or data which already has been the subject o f an 8(e) notification by 3M: Attached Submission Related Study/Data Already Filed Under 8(e) 1. Amended Analytical Study, 2(N-Ethylperfluorooctane Combined Oral (Gavage) Fertility, sulfonamido)-ethanol in Two Generation Rat Reproduction, Developmental and Perinatal/Postnatal Determination of the Presence and Concentration of PFOS, Reproduction Toxicity Study of N- M556, PFOSAA, and PFOSA in the Liver and PFOS, EtFOSE in Rats, 3M Reference No. T- M556, PFOSAA, PFOSA and EtFOSE-OH in the Sera of 6316.5, June 30, 1999, full report CrkCDBR VAF/Plus Rats Exposed to EtFOSE-OH, 3M submitted February 15, 2000 to r-o Reference No. T-6316.5, Analytical Report TOX-013, LRN-U2095, June 11, 2001. supplement earlier filing S ---------------------------------------------- (m3jO0- ro cn 0 70 -O pri X Ii mo Contain NO CBI 3?* J* o O CO ro or TSCA Section 8(e) Docket Coordinator Page 2 Attached Submission Related Study/Data Already Filed Under 8(e) 2. Analytical Laboratory Report, Determination of the Presence and Concentration of Potassium Perfluorooctanesulfonate (CAS Number: 2759-39-3) in the Serum and Liver of Sprague-Dawley Rats Exposed to PFOS via Gavage, Laboratory Report No. U2006, Requestor Project No. 3M TOX 6295.9, October 27, 1999. 3. Report Amendment 1, Combined Oral (Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of PFOS in Rats, Argus Research Laboratories, Inc., Protocol 418-008, Sponsor's Study No. 6295.9, April 13, 2000. Combined Oral (Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of PFOS in Rats, Argus Research Laboratories, Inc., Sponsor's Study No. 6295.9, June 10, 1999, full report submitted February 15, 2000 supplementing earlier filing 4. Analytical Report, Determination of the Presence and Concentration of Perfluorooctanesulfonate, Perfluorooctanesulfonylamide, M556, and M570 in the Liver and Sera Samples, 3M Environmental Laboratory Ref. No. U2636, TOX-028, February 23, 2001 13-Week Dietary Study of N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats, 3M Ref. No. T6314.1, Covance Study No. 6329-225, dated June 30, 2000, Section 8(e) filing July 24, 2000 5. Analytical Laboratory Report, Determination of the Concentration of PFOS, PFOSA, PFOSAA, and EtFOSEOH in the Sera and Liver of CrhCDBR VAF/Plus Rats Exposed to N-EtFOSE, 3M Environmental Laboratory Report No. TOX-098, Laboratory Request No. U2402, 3M Ref. No. T-6316.7, February 6, 2001. Final Report, Oral (Gavage) Developmental Toxicity Study of 2(NEthylperfluorooctanesulfonamido)ethanol in Rats, 3M Reference No. T6316.7, December 17, 1998, submitted to Section 8(e) docket per letter of August 21, 2000 6. Analytical Laboratory Report on the Determination of the Presence and Concentration of Potassium Perfluorooctanesulfonate (PFOS) or another metabolite of 2(N-ethylperfluorooctanesulfonamido)-ethanol (NEtFOSE) in Liver and Serum Specimens, 3M Environmental Laboratory Report No. TOX-097, Laboratory Request No. U2452, 3M Ref. No. T-6316.8, February 8, 2001 Final Report, Oral (Stomach Tube) Developmental Toxicity Study of NEtFOSE in Rabbits, 3M Reference No. T-6316.8, January 11, 1999, submitted to Section 8(e) docket per letter of August 21, 2000 7. Final Report, Alexander, B., Mortality Studies of Workers Employed at the 3M Decatur Facility, University of Minnesota, April 26, 2001. Preliminary data submitted to Section 8(e) docket in letter of December 15, 2000 TSCA Section 8(e) Docket Coordinator Page 3 Attached Submission Related Study/Data Already Filed Under 8(e) 8. Final Report, Acute Oral Toxicity Screen with T-3290CoC in Albino Rats, Safety Evaluation Laboratory, Riker Laboratories, Inc., Project No. 0882AR0362, 3M Reference No. T-3290 (40 % K+PFOSAA in 3 % EtOH, 17 % IPA and 40 % H2O, L-6778, F-6873, Lot 501), November 5, 1982 [Bibliography entry in Docket AR-226, fin a l report was to be moved to TSCA 8(e) docket] Acute Oral Toxicity Screen with T3290CoC in Albino Rats, Safety Evaluation Laboratory, Riker Laboratories, Inc., Project No. 0882AR0362, 3M Reference No. T3290 (40 % K+PFOSAA in 3 % EtOH, 17 % IPA and 40 % H20, L-6778, F6873, Lot 501), November 5, 1982, submitted to Section 8(e) docket in August 21, 2000 self-audit letter (which erroneously refers to rabbits rather than rats) 9. Giesy, J.P., and K. Kannan, Accumulation of Perfluorooctanesulfonate and Related Fluorochemicals in Fish Tissue, Michigan State University, June 20, 2001. Preliminary data submitted to Section 8(e) docket May 26, 1999 10. Giesy, J.P., and K. Kannan, Accumulation of Perfluorooctanesulfonate and Related Fluorochemicals in Mink and River Otters, Michigan State University, June 20, 2001. 11. Giesy, J.P., and K. Kannan, Perfluorooctanesulfonate and Related Fluorochemicals in Oyster, Crassostrea Virginica, From the Gulf of Mexico and Chesapeake Bay, Michigan State University, June 20, 2001. 12. Giesy, J.P. and K. Kannan, Perfluorooctanesulfonate and Related Fluorochemicals in Fish-Eating Water Birds, Michigan State University, June 20, 2001. 13. Giesy, J.P. and K. Kannan, Accumulation of Perfluorooctanesulfonate and Related Fluorochemicals in Marine Mammals, Michigan State University, June 20, 2001. If you have any questions about this submission, please contact me at (651)737-4795. Sincerely, Enclosures Georjean Adams Manager, 3M Corporate Product Responsibility