Document O3Dzq9nkoRB2Dg7e8ko4842R1

3M SpecialtyMaterials 3M Center St.Paul,MN 55144-1000 651733 1 tOO VIA OVERNIGHT DELIVERY December 22, 2000 Document Processing Center (7407) Officeof PollutionPrevention and Toxics U.S. Environmental ProtectionAgency 401 M StreetSW Washington, D.C. 20460 Attention:For Your InformationDocket - Docket No. AR-226 Re: Informationon Perfluorooctane Sulfonates and Related Compounds Dear Siror Madam: This continues 3M's voluntarysubmissions of data on perfluorooctane sulfonatesand relatedcompounds, as partof our ongoing dialogwith EPA regarding fluorochemistry. Contents of this Submission Inthissubmission, we are enclosing some new informationand some olderdocuments thathave only recentlybeen located.Allof the informationin thissubmission relatesto healtheffectsresearch. We expect to providean environmental submission, along with additionalnew healtheffectsresearch information,withinthe next few months. AnalyticalData forPreviouslySubmitted Studies This submission includesrecentfinalanalyticalreportsprovidingliverand serum values forthe PFOS monkey study and the N-ethylFOSE twogenerationratstudy. The PFOS monkey study reportupdates an interim analyticalreportsubmitted May 4, 2000. The analyticadlata forthe N-ethyl FOSE two-generationstudy had not previouslybeen submitted. As indicated inthe draftInitiaAlssessment Report,the laboratoryiscontinuingto update the serum and livervalues forvariousstudies.Additionalrevisedvalues for other studieswillbe forthcoming infuturesubmissions. December 22, 2000 Page 2 This submission also includesanalyticavlalues on liverand serum from 1978/79 monkey studieswith PFOS and N-ethylFOSE. We have only recentlylocatedthese old analyticalreports. AdditionalCopies of InformationSubmitted to TSCA Section 8(e) Docket For convenience, we have includedinthispackage copies of three recent submissions under TSCA Section8(e). The firstrelatesto an update of the mortalitystudy at the Decatur plant where fluorochemicalsare produced, showing a statisticalsliygnificant excess of urinarybladdercancer (based on threecases). Based on allof the availabletoxicologyinformation,we do not believeitisbiologically plausiblethatthe observed excess relatesto fluorochemicalexposure. We are continuingto investigatethisfinding,and as indicatedinthe Section 8(e) lettert,he reportisstililn preparation. The second Section 8(e) submission reproduced here forconvenience pertainsto findingsfrom the 104-week bioassay using N-ethylFOSE. That study resultedina statisticalsliygnificanetxcess of benign hepatocellularadenomas, and one hepatocellularcarcinoma, infemale ratsonly,and only at the high dose. The finalreporton thatstudy willbe delayed. Given the recentfindingof an excess of bladder cancer in the Decatur mortalitystudy,we have asked the laboratoryto review urinary bladder tissueof allanimals inthe study. The laboratoryhad already examined the urinarybladders of high-dose and controlanimals,with no findingsof note. However, we have asked forthe additionalwork to ensure thatthere isno abnormal pathology present inthe urinarybladders at any dose. We expect thiswork may delay issuance of the finalreport on the chronicN-ethylFOSE study by severalmonths. We have therefore includedthe Section 8(e) lettercontainingthe significanitnformationfrom the chronicbioassay inthispackage. (We have not yet receivedthe resultsof the chronicPFOS study. We have made the same request regarding additionaltissueexamination inthatstudy,and accordingly,also expect thatstudy to be delayed pending completion of additionalwork.) We have also includeda reporton a 13-week dietarystudy of N-Methyl PerfluorooctanesulfonamidoEthanol (N-Methyl FOSE) submittedto the TSCA docket by lettedrated July24, 2000. December 22, 2000 Page 3 Mixtures Our seriesof data submissions have provided to you studiesadministering specifiedfluorochemicals(13 chemicals,countingPFOS acid and itsvarious saltsas one, were covered inthe document submissions). We also provided a submission inJune 2000 regardingmixtures inwhich PFOS ispresent as an intentionailngredient.That mixturesubmission essentiallcyovered our AFFF product,known as Lightwater@,which containssmall amounts of PFOS. As Idiscussed ina recenttelephone conversationwith Dr. Oscar Hernandez of EPA, the utilitoyfthese mixturestudiesfortoxicological evaluationand riskassessment islimited.Accordingly,although 3M has locateda few additionalsuch studies,we agreed thatthese need not be submitted. Dermal or intravenousabsorptionstudiesthatadministered a covered fluorochemicalto testanimals have alreadybeen suppliedinour previous submissions. We note thatthere also existstudiesthatadministereda mixtureto the testspecies,and then measured the presence of a covered chemical such as PFOS inthe animal. The data from these studiesisof limitedutilithyo,wever. The studieswere intended to be only a screeninglevelsurvey of exposure potential.They do not indicatethe rateof absorption or whether the presence of any fluorochemicalresultedfrom absorption versus metabolism. Many of the products administeredto the animals were experimental ratherthan commercial products,and insome cases only limitedinformationisavailableas to the composition of the testmaterial.As with the AFFF studieson mixtures,and particularlgyiven the limited usefulness of these mixturestudies,we are not providingcopies of these studies. Compact Discs We have previouslyprovided you with a compact disc containingour April and earlyMay submissions. We are now enclosingtwo additionalCDs: Disc 2 covers the submissions dated May 23, 2000 through June 2000. Disc 3 covers the August submission and thissubmission. Thus, you willnow have allof the data submissions in electronicformat. Note thateach of the document submissions may includeinformationon multiple chemicals. As with the firsCtD, the enclosed CDs includea copy of the cover letter and index foreach submission,followed by the data. Also as with the firsCtD, these electronicdocuments are forread-onlypurposes and are not to be December 22,2000 Page 4 modified. 3M willmaintain paper copies, and inthe event of any discrepancy, the 3M paper copieswillbe consideredcontrollingT.he CDs includeonlythe public versionof any confidentiailnformationE;PA should refertothe paper copies for any informationsubmittedunder claimof confidentiality. We willcontinuetoprovideinformationon a regularbasisas itbecomes available.Iwillbe retirinfgrom 3M effectivJeanuary 10,2001. You may feel freetocontactme untitlhen,or afterthat,please contactmy successor Michael Santoro (atthe same phone number shown below)with any questions. Very trulyyours, WilliamA. Weppner, Ph.D. Directorof Environmental,Health Safetyand RegulatoryAffairs SpecialtyMaterialsMarkets 3M Building236-1 B-1 0 3M Center St.Paul,MN 55144 651-733-6374 (phone) 651-733-1958 (fax) E-mail:waweppner@mmm.com cc: Dr.CharlesAuer Dr.Oscar Hernandez (withindexbutwithoutotherenclosures) ATTACHMENT TO LETTER OF DECEMBER SUPPLEMENTAL SUBMISSION 22,2000 TOXICOLOGY AND MEDICAL SURVEILLANCE PFOS Perfluorooctane sulfonate Medical Surveillance 1. Lettersubmittedunder TSCA SectionS(e)regardingupdateof Decatur plant mortalitystudy,December 15,2000. Repeat Dose I. AnalyticalLaboratoryReport,September 19,2000, "26-Week Capsule ToxicityStudy with PerfluorooctanSeulfonicAcid Potassium Salt(T-6295) inCynomolgus Monkeys, Determinationof the Presence and Concentration ofPerfluorooctanesulfonat(ePFOS) in Liverand Serum Samples,"to accompany Covance LaboratoriesInc.,Study No. 6329-223, 3M Medical Department Study No. T-6295.7,ReportNo. FACT TOX-030 [unaudited draftof in-lifreeportand interimreportof preliminaryanalyticadlatawere submittedMay 4,2000]. [Note:This reportcontainsrevisedanalyticadlataupdatingthatinthe October 2000 draftInitiaAlssessment Report. The draftInitial Assessment Report containeddataavailableas of July2000 and noted thatrevisionswould be forthcoming.] 2. TechnicalReport Summary and CentralAnalyticalLaboratoryReport No. 6967,providinganalyticadlataforNinety-Day Subacute Rhesus Monkey ToxicityStudy,with Fluoradg FluorochemicalSurfactantFC-95, InternationaRlesearch and Development Corporation,ProjectNo. 137-092, 3M ReferenceNo. T-335 1,August 4, 1978 [finalin-lifreeportwas submittedMay 4,2000]. ATTACHMENT TO LETTER OF DECEMBER SUPPLEMENTAL SUBMISSION 22,2000 N-ETFOSE alcohol- NF-ethylperfluorooctanseulfonamidoethanol Genotoxicit 1. FinalReport,L5178Y TK +/-Mouse Lymphoma Forward Mutation Assay with a ConfirmatoryAssay with N-ETFOSE T-6316, Covance Laboratories, Inc.,Study No. 20785-0-431 ICH, 3M Reference No. T-6316.12,September 5,2000 [Note:This isa repeatof FinalReport,Evaluationof the Mutagenic Activityof T-6906 in an In VitroMammalian CellGene Mutation Test with L5178Y Mouse Lymphoma Cells,NOTOX Study No. 223458, 3M ReferenceNo. FM-3923, December 22, 1998,submittedMay 18,2000, with a lettefrrom Covance Laboratorie(sreviewingtheNOTOX study and concludingitwas technicallyinadequateand should be repeated)]. Repeat Dose I. Lettersubmittedunder TSCA Section8(e)regardingresultsof 104-week chronicstudy,December 4,2000. 2. TechnicalReport Summary and CentralAnalyticalLaboratoryReport No. 6995, providinganalyticadlatato accompany Ninety Day Subacute Rhesus Monkey ToxicityStudy on FM-3422, InternationaRlesearch and Development Corporation,Study No. 137-088,August 16, 1978 [finalinlifereportsubmittedMay 18,2000]. Teratolo,u@&y Reproductive 1. Combined Oral (Gavage) FertilitDye,velopmental and Pen'natal/Postnatal ReproductionToxicityStudy ofN-ETFOSE inRats,3M Reference No. T6316.5,Argus ProtocolNo. 418-009, FACT-TOX-013, June 30, 1999 ["twogenerationstudy"previouslyreportedto TSCA 8e docket] a. Report Amendment 1,October 12,2000, amending figure. b. AnalyticalLaboratoryReport,October 9,2000, "Determination of the Presence and Concentrationof PFOS, M556, PFOSAA, and PFOSA inthe Liverand PFOS, M556, PFOSA, and ETFOSE-OH intheSera of Crl:CDOBR VAF/Plusg) Rats Exposed to Et-FOSE-OH" ATTACHMENT TO LETTER OF DECEMBER SUPPLEMENTAL SUBMISSION 22,2000 N-MEFOSE alcohol-TN-methyl perfluorooetanseulfonamidoethanol RepeatDose 1. Covance Laboratory,13-Week DietaryStudyofN-Methyl PerfluorooctansulfonamiEdtehanol(N-MeFOSE) inRats,and 4-week Range-FindingStudy,3M ReferenceNo. T-6314,alongwith lettedrated July24,2000 submittingreportstoTSCA Section8(e)docket. PFOA Perfluorooctanoicacid .Genotoxicity 1. Reportto3M Company, ReverseMutationStudieswith T-1485 inFive SalmonellaStrainsand One.Saccharomyces StrainI,ndustriaBlio-Test LaboratoriesI,nc.,IBT No. 8540-09238,August 10,1976. PublishedLiteratur(eBibliographOynly) I. Olsen,GW, Bum*s,JM, Burlew,MM, and Mandel, JH, Plasma Cholecystokininand HepaticEnzymes, Cholesteroland Lipoproteinsin Ammonium PerfluorooctanoatPeroductionWorkers,Drug and Chemical Toxicology23(4):603-620 (2000). 2. Reo, NV, Adinehzadeh,NMR SpectroscopicAnalysesofLiver Phosphatidylcholinaend PhosphatidylethaminBelosynthesisinRats Exposed to Peroxisome Proliferato-rsA Classof Nongenotoxic HepatocarcinogensT,oxicologyand AppliedPharmacology 2000; 164:113126. 3