Andrea V.

A t ^ 3-6 "McCrea, Deborah" <mccrea@taftlaw.com> 06/12/2009 03:54 PM To NCIC OPPT@EPA cc "Bilott, Robert A."

P-1 "McCrea, Deborah" < m ccrea@ taftlaw .com > 12/14/2009 03:38 PM To NCIC O PPT@ EPA cc "Bilott, Robert A." < bilott@taftlaw.com> bcc Subject 12/14/2009 Letter To EPA Docket Center f i / L Z I G ' 3> 9 x l Taft/ Deborah McCrea / Legal Assistant Taft Stettinius & Hollister LLP 425 Walnut Street, Suite 1800 Cincinnati, Ohio 45202-3957 Tel: 513.381.2838 Fax: 513.381.0205 www.taftlaw.com / mccrea@taftlaw.com Internal Revenue Service Circular 230 Disclosure: As provided for in Treasury regulations, advice (if any) relating to federal taxes that is contained in this communication (including attachments) is not intended or written to be used, and cannot be used, for the purpose of (1) avoiding penalties under the Internal Revenue Code or (2) promoting, marketing or recommending to another party any transaction or matter addressed herein.

INTERIM REPORT #3 - Analysis of Fish and Clam Samples STUDY TITLE Analysis of Perfluorobutanesulfonate (PFBS), Perfluorohexanesulfonate (PFHS), and Perfluorooctanesulfonate (PFOS) in Water, Soil, Sediment, Fish, and Clams Using LC/MS/MS for the 3M Decatur Monitoring Program DATA REQUIREMENTS EPA TSCA Good Laboratory Practice Standards 40 CFR 792 STUDY DIRECTOR Jaisimha Kesari P.E., DEE Weston Solutions, Inc. 1400 Weston Way West Chester, PA 19380 Phone: 610-701-3761 INTERIM REPORT COMPLETION DATE June 17, 2008 TESTING FACILITY MPI Research, Inc. 3058 Research Drive State College, PA 16801 Phone: 814-272-1039 STUDY SPONSOR 3M Company 3M Building 0236-01-B-10 St.

\P NAME ORGANIZATION ^VoCTJsnI l^ JU r "T jW\ '^>iaAuaQ/A ------------- 1---------\-------------1 - ^ S .

3M ENVIRONMENTAL LABORATORY REPORT NO.

SEVERN TRENT LABORATORIES ANALYTICAL REPORT JOB NUMBER: 244963 Prepared For: Weston Solutions, Inc. 1400 Weston Way Building 5-2 West Chester, PA 19380-1499 Project: Confidential Decatur - FC Investigation Attention: Sue Stefanosky Date: 03/23/2006 Signature Name: Richard C.

SEVERN TRENT LABORATORIES ANALYTICAL REPORT JOB NUMBER: 244964 Prepared For: Weston Solutions, Inc. 1400 Weston Way Building 5-2 West Chester, PA 19380-1499 Project: Confidential Decatur - FC Investigation Attention: Jai Kesari Date: 03/23/2006 Signature Name: Richard C.

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mi 3M 3.V1 C.eneral Ottices 3M Center St.

AR226-1030A035 BACK TO MAIN Study Title Microbial Metabolism (Biodegradation) Studies of Perfluorooctane Sulfonate (PFOS) II.

BACK TO MAIN Focus Environmental, Inc.

BACK TO MAIN BIODEGRADATION (Anaerobic Sludge) TEST SUBSTANCE___________ Identity: Perfluorooctanesulfonate; may also be referred to as PFOS or FC-95. (1-Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8heptadecafluoro-, potassium salt, CAS # 2795-39-3) Remarks: The 3M production lot number was 217 (TN-A-2130).

3M General Offices 3M Center St.

New Datatiff AR.&3.6-062.5 Completion of two generation reproductive studies for perfluorooctane sulfonate and EpetFrfOluSoEro, oacntdancerossusl-ffoonsatetreinstgufdoyllow up to Pharmacokinetics during pregnancy studies Second species (rabbit) teratology study Completion of 180 day repeat dose study in primates with one year recovery 3M Medical Department March 7,2000 I Pending Two-year feeding studies EtFOSE - In-life done 4/2000 Perfluorooctane sulfonate - In-life done 4/2000 6 month and one year recovery after 180 day feeding study in primates ADME study in primates 3M Medical Department March 7,2000 Pending Human sera studies Health claims study Update mortality study Mechanistic and metabolic studies 3M Medical Department March 7,2000 3 ResultsFo- sRteerpirnogdSutcutidoines/Cross- N0.O4 EmLg/fkogr/dreopfrpoedruflcutiovreoeonctdapnoeinstuslfonate is Perinatal mortality is predominantly a pup effect rather than a maternal effect Effect on cholesterol metabolism is hypothesized mechanism - studies planned to test hypothesis 3M Medical Department March 7,2000 ResultsD-oPseriSmtuatdeyRepeat 0.15 mg/kg/d well tolerated for 6 months (apparent NOEL) Cholesterol level decreased at perfluorooctane sulfonate serum concentrations greater than 100 ppm (in the high dose group) 2 deaths in males at 0.75 mg/kg/d that were apparently compound relateyd At the high dose (0.75 mg/kg/d) body weight liver weight and liver morphology were affected 3M Medical Department March 7,2000 r Results - Sera Concentrations Perfluorooctane sulfonate serum concentrations increase linearly with dose in l8o3w-1a0n7dpmpmid) dose groups (16-20 ppm and Perfluorooctane sulfonate serum tchoencheinghtradtoisoengs rfooullpows, ewditahbmipahxaimsicumcurvvaeluiens at 250-300 ppm 3M Medical Department March 7,2000 Background "19O6r8ganic fluorine" reported in human sera in 3M medical surveillance from 1976 to present Aconmalpyosuesndfosrdsopseecaiffitcerflu19o9ro2o-rdgeatneicction limit less than 50 ppb in 1997 Mcoocncuutltepimpaltpeiooanrnaaarlllyyysseiesxrpfaroossamemd)hpfilsientsodr(nipcoeanrfn-ludorooctane sulfonate at less than 50 ppb 3M Medical Department March 7,2000 7 Background Various studies, including medical surveillance, done over the last 25 years In the last two years have used outside experts to identify needs and help define studies Have created Scientific Advisory Panel for additional review 3M Medical Department March 7,2000 2 Review - Data in Health Effects Paper ADME Metabolic precursors to perfluorooctane sulfonate Repeat dose feeding studies - rat and primate Genotoxicity Teratology 3M Medical Department March 7,2000 Review - Data in Health Effects Paper (Continued) Cross-sectional study of exposed employees Mortality study at production plant site Irnepterroidmucdtaivtae fsrtoumdy2-generation Interim data from new repeat dose primate study 3M Medical Department March 7,2000 10 Results The additional data does not suggest a health risk associated with the levels of perfluor loctane sulfonate found in the sera of occupationally or non-occupationally exposed employees, blood bank samples or commercially available serum. 3M Medical Department March 7,2000 //