Document kJYw5jDyG4ZLLLyvBN4gb8kB
3M General Oflrices
3M Center St.Paul,MN 55144-1000 6127331110
May 4,2000
VIA FEDERAL EXPRESS
Dr.CharlesAuer Director Chemical ControlDivision OfficeOf PollutioPnreventionAnd To)Cics UnitedStatesEnvironmentalProtectioAngency. 401 M Street,Southwest Room 403 EastTower (MailCode 7405) Washington,D. C. 20460
Re: Information On Perfluorooctane Suffonates
Dear Charlie:
Pursuanttoourrecentcommunications,3M isenclosingadditional informatioonn perfluorooctanseulfonates.The enclosedinformatiosnupplements informatiosnubmittedtoyou previouslyunder cover ofourApril21,2000 letterA.gain, we are providingthisinformatioonn a voluntarybasisas partofour continuing discussionswithEPA regardingfluorochemistry.
The enclosedinformatiocnoversperfluorooctanseuffonatesi,ncluding CAS numbers 1763-23-1(acid)2;9081-56-9(ammonium salt)7;0225-14-8(DEA salt); 2795-39-3(potass7ium-sal2t9)4;57-72-5(lithiusmalt).Itconsistsof thefollowing:
Copiesof post-1975studiesand certainotherinformatiornelatintgothefollowing environmentaslcienceareas:(i)physicaland chemicalproperties(;ii) environmentaflateand transport(;iiein)vironmentalmonitoringa;nd (iv) ecotoxicityF.or each study,3M has prepareda summary inthe HPV mrobust summaryn format.An executivesummary alsohas been includedforeach area.
Copies ofpost-I975 studiesand certainotherinformatiornelatintgothefollowing healtheffectasreas:(i)acutetoxicit(yi;ig)enotoxicit(yi;irie)peated-dosetoxicity;
Chades Auer May 4, 2000 Page 2
(iv)pharmacokinefic(sv;)teratologayn;d (vim)edicalsurveillancaend epidemiology.3M has incjudeda detaileidndexofthisinformation.
A lisotfallstudiesinprogressand plannedstudiesa,longwithstudyprotocolsor studyplans,where availableW.ith regardto thehealtheffectsarea,thislist supplementsthelisptrovidedunder coverof ourApril21,2000 lettetro you.
A bibliographoyf pre-1976studiesintheenvironmentalscienceand health effectsareas on perfluorooctanseulfonates.
A bibliographoyfacutetoxicitsytudieson perfluorooctanseulfonatese,xceptthat we are providingcopiesofkey acutestudies(withreferencetotheHPV guidance).
A bibliographoyfpublishedstudieson theperfluorooctanseuffonatesin3M's possession.
=> An indexofsubmissionsmade by 3M totheTSCA Section8(e)docket.This indexhas been subdividedby EPA docketnumber. Ratherthan attemptto segment theindexforperfluorooctanseulfonatesonly,we have includedother fluorochemicaslubmissionson theindex,as severalof3M's submissionshave dealtwithmultiplfeluorochemicals.
3M iscontinuingourfilereviewand Villsupplementtheenclosed informatioans appropriateA.s you reviewthisinformationw,e ask thatyou bear severalpointsinmind:
The enc4osedinformatiosnpans severalboxes. We have organizedthe informatioinneach box vathlabeledfilfeoldersand indicesto aidEPNs review. To ensurethatyou and your staffareabletoaccessthe most pertinent informationw,e alsoareattachingtothiscoverlettetrheexecutivesummaries for theenvironmentalscienceareas and theindicescoveringstudiesand other information.
Insome cases,theenclosedinformatiorneflectrsecentdevelopmentsthatmay supplementstudiesand otherinformatiopnreviouslpyrovidedto you. As just one example,3M's previouslsyubmitteddocument entitle"dFluorochemicalUse,' DistributiAonnd Release OvervieW (5126/99)containsa qualitativaessessment based on the assumptionthatallotherfluorochemicalcsouldbreakdown to perfluorooctanseuffonatesA.notherdocument submittedby 3M entitled NSulfonatedPerfluorochemicalisnthe Environment:Sources,DispersionF,ate and Effectsa'lsoprovidedestimatesof potentiaelxposure and waste generation based on such an assumption. Recent informatioinntheenvironmentalfateand transporatrea suggests,however, thatthisassumptionmay reflecatn unrealistic
ChadesAuer May 4,2000 Page3
u worstcase'whichsignificaonvtelrystateexsposurpeotentitaoplerfluorooctane sulfonateIsnp.articutlhairis,nformat(iwohnicihsenclosedi)ndicattehsat perfluorooctsaunlefonatmeasy notbe a degradatipornoducotfmany fluorochemicaanldtshathighmoleculawreighftluorochemipcoallymerasnd fluorochemipchaolsphateester'sarreelativsetlayblientheenvironment.
=> The encloseidnformatinocnludessomestudieasndotheirnformatoinon mixturecsontainipnegrfluoroocstualnfeonatAessw.e havediscusse3dM,will beprovidiynoguwithfurthienrformatoinoonthefrluorochemiwciatlhsitnhenext severawleeks.We wililncludaedditiosntauldieasndotheirnformatoinon mixturecsontainipnegrfluorooctsaunlefonataettshattime.
3M hasnotprovideydouwithalalnalyticchaelmistreyporotns perfluorooctane sulfonateRsa.therw,e haveenclosecdertaainalyticchaelmistreyportwshich may proveusefutloEPA ininterprecteirntgasitnudieusn;derstandtihnegdetails ofanalyticchaelmistmreythodso;rve(ifyihnugmanandbiomonitordiantga.
3M iscontinuiintgwsorktorefinteheanalyticchaalracterizaotftihoen perfluoroocstualnfeonatteessmtateribaelingusedforourcurrenst udy programW.e wilkleepyouinformeodfanypertinednetvelopments.
Finallpyl,easneotethastomeofthiisnformatqiuoanlifaisecsonfidential businesisnformat(iCoBnI)C;BIinformathiaosnbeenplaceidna separate, labeleednvelopeA.lsoi,ncorrecatplpylieldegendrselatitnoglegaplrivileges andproprietparroytectihoanvsebeenremovedfromcertadioncuments.
CharlesAuer May 4,2000 Page 4
3M looksforwardtodiscussingtheenclosedinformatiownithyou and otherEPA staff.Inthemeantime,pleasedo nothesitatteo contactme withany questions.
Very trulyours,
Enclosures
WilliamA. Weppner, Ph.D Directoorf EnvironmentalH,ealth,Safety And RegulatoryAffairs SpecialtyMaterialsMarkets 3M Bldg 236-1 B-10 3M Center St.Paul,MN 55144 E-mail:wAwWpnerAmmm.com
Attachment to Lefterto C. Auer Dated May 4,2000: Environmental Studies on Perfluorooctanesulfonate(sPost-1975)
PhysicallchemiPcraolperties
Title
Determination of the Metting PoinVMetting Range Point(Not Conducted)
of PFOS;
Boiling
Laboratoryor Author Wildlife
InternationalL,td.
DeterminatioonftheVapor Pressure ofPFOS Using the Spinning
Rotor Guage Method
Wildlife InternationalL,td.
PFOS: Determination ofthe n-Octanol/Water PartitioCnoefficient
Wildlife
by the Shake Flask Method - A Non-GLP FeasibilitSytudy in
InternationalL,td.
SupportofWildlifIenternationaLlt,d.ProjectNumber 454C-108
Completion Date
2/24/99
Type
RobustSwnmari", FinalReport Protocol
5/5/99
Robust Summary, Fr@W Report Proto=l
2/11/()o RobustSwnmary, F"sibUitySbxly
TestingResults:Air-WaterPartitioCnoefficien(tKAw)forPFOS
3M/Wildlife
InternationaLlt,d.,U
ofTrent
DeterminatioonftheWater SolubilitoyfPFOS by theShake Flask
Wildlife
Method
InternationaLlt,d.
TechnicalReport.SolubiliMteyasurements on FC-95
3M Env. Lab
SolubiliEtsytimateofFC-95 by use ofXertexTOC Analyzer Xertex,3M Env. Lab
3/19/99
Robust Summary, LetterReport
4126100 2/6181
6129/82
RobustSmrrZ7FinalReport Protocol
BrW Robust Summary, O*Lie from EndwinTucker (311193)F,inalReport
BrW robustsummary, wwropw
EnvironmentFaalteandTransport
Title
AdsorptionofFC 95 and FC 143 on Soil(Note:the3M Env.Lab summary istdied:Summary ofthe SoilAdsorptionstudyofthe Potassium SaltofPerfluorooctanesulfoanciicd,7/22/98)
FC-95/PhotolysiS;-tudyUsingSimulatedSunlight(.Note:the3M Env.Lab summary istitleds:ummary ofPhotolysisStudy Using SimulatedSunlighton the Potassium Saftof Perfluorooctanesutfoanciicd) BiodegradatioSntudiesofFluorocarbons(8/12f76r)eportand BiodegradatioSntudiesof Fluorocarbons- III(7119f78)report. (Note:bothreportsummarized withone robustsummary) BODICOD resultfsorFC-94-X (LisaltofPFOS)
BODICOD resultfsorFC-99 (DEA saftofPFOS)
Transportbetween environmentalcompartments (fugacdy modeling)incjudedinlettefrrom Don Mackay on the airtwater partitionicnogefficiecnatlculations AnalysisforfluorochemicalisnBluegilflish.
Laboratoryor Author
3M Env.Lab
3M Env.Lab
Completion Date
2/27/78
Type
RobustSwnmoy, 3M Env. Lab Summary, Comments fromStol~ A Boyd from MSU, Final Report
It9f79
Robust Summary, 3M Eiw. Lab Summary, FinalReport
3M Env.Lab Pace Analytical 3M Env.Lab
B/12/1976, ww Robust 7/19178 SLffnmwy.2 Final
Repons
3/30194 618179
CompuW-genw*W
Summary ofTes" Results
Robust Summary U-4 fmi Reports
DMER
No date
Robust Summary.
law report
3M Env. Lab
5/17179
Robust SLxnmwy, TechnicalReport
EcotoxiciEtlyements
Title
PFOS: A 96-HouSrtatAicuteToxiciTteystwiththeFathead Minno(wPimspheplreosmoiss) PFOS:A 96-HouTroxicTietsytwitthheFreshwatAelrga (Selenastrumcapricomutum)
PFOS: A 48-Hour StaticAcute ToxicityTest withtheCladoceran (Daphnia magna) PFOS: A 96-Hour ShellDepositionTest with the Eastern Oyster (Crassostreavirginica)
Laboratoryor Author
Completion TYPO Date
VVildlife
4t26/0()
InternatiLotnda.l,
RobustSLwnmwy. FinaRleportP. I
Wildlife InternationaLlt,d.
4/26/00
Robust Summary, FirW Report Protocol
Wildlife InternationalL,td.
4/26100
Robust Summary. Final Report Protocol
Wildlife InternationaLlt,d.
4/26/00
Robust Surnmwy, FinalRepoM Protocol
PFOS: A 96-Hour StaticAcute ToxicityTest withtheFreshwater
Wildlife
Mussel (Unio complamatus)
InternationalL,td.
4/26/DO
Robust Summery, FkwlRepoM
PFOS: An ActivatedSludge, RespirationInhibitioTnest
Wildlife lntemafionLatld,.
PFOS: A 96-HourStatiAccuteToxiciTteystwiththeSaltwater
Wildlife
Mysid(Mysidopsibsehia)
lntemabonalL,td.
PFOS: An EarlyLife-StaTgoexicitTyestwiththeFatheadMinnow
Widlife
(Pimephales promelas)
InternationaLlt,d.
PFOS: A Semi-StaticLife-CycleToxicitTyest withthe Cladoceran
Wildlife
((Daphniamagne)
lntemauanal,Ltd.
PFOS: A Flow-throughLife-CycleToxicityTest withtheSaltwater
Wildlife
Mysid (Mysidopsibsehis)
InternationLatld,.
PFOS: A DietaryLC50 StudywiththeMallard
Wildlife InternationalL,td.
PFOS: A DietaryLC50 Study with the Northam Bobwhite
Wildlife InternationaLlt,d.
4f28=
RobustSLKnrnwy, FinalReport Protocol
4/26/()o Robust summary.
FinalRepoM Protocol
4/26/00
Robust Summary, Fw%alRopor4 Pmtocei
4/26/00
Robust Summary. FinalRepoM Protocol
4/261()o Robust Summary,
FinalReport Protocol
4126/00
Robust Summary, Final Report Protocol
4/26/00
Robust Summary, Fhal RepoM Prot=W
Mufti-PhaseExposure/RecoveryAlgalAssay Test Method
3M Env. Lab
The Effectsof Continuous Aqueous Exposure to 14C-78.02 on EG&G HatchabiliotfyEggs and Growth and SurvivalofFryofFathead Minnow (Pimephalespromelas) and Summary ofhistopathological Examinations of Fathead Minnow (Pimephales promelas) Exposed to78.02for30 Days
Bionomics
EffectofPotassium PerfluorooctanesulfonaatneSurvivale,tc. (Daphnidreproduction)
3M Env. Lab
Pimephales pmmelas 96-hourToxicityTest Data Summary. Sample FC-94-X (Lisaftof PFOS)
3M Env. Lab
48-HR Acute Toxicityto Daphnia, Dephnia magna. FC-94-X (Li saltofPFOS) MicrobiesMicrotoxToxicityTest. Sample: FC-94-X (Lisaftof PFOS) EvaluationofFC-94-X by OECD ActivatedSludge Respiration InhibitiToenst #209, Review ofOECD 209 and BOD/COD Test ResultsforFC-94-X,testdata sheets (LisaftofPFOS) 96-HourAcute ToxicitTyeston BluegilSlunfish(FC-99,DEA saft ofPFOS)
Acute ToxicittyoActivatedSludge(FC-99,DEA saftofPFOS)
3M Env. Lab
3M Env. Lab
3M Env. Lab
Analytical BioChemistry LaboratoriesI.nc. 3M Env. Lab
Microtoxdata forFM-3820 (28% PFOS)
3M Env. Lab
12/16/81 August,1978 December,
1978
2/13/84 3/25194 2/10/94 2[7/94 7/22/98
7/13f7g
6/4179 7/24/91
Brief Robuo SLAMMWY, Fomm Report BrW Robust Summary, FhW Reports
Snof Robust Summary, F!nW Report Robust Summary,
SummaryPap,
copies d data Robust Summary,
Coosaof dW
Robust Sumrnwy.
wmmwy ofresults,
cwi- of deM.
Robusstummary, SummaryPago.
copies of doW
Robust Summary NW FhalRepon
Robust Summary a-4 Copies of data Robust Summary daW summary
Acute ToxicitytoDaphnia magna FoFr-M-3820 (28% PFOS)
Toxicityto Algae (Selenastrum CaPricOmutum) PFOS)
for FM-3820
(28%
EnviroSystems of
Resource Analysts.
Inc.)
EnviroSystems of Resource Analysts,
Inc.)
3/26191
June, 1991
ROWM Sumrnary ww FinalReport
Rao- s-mary ww FinaRleport
Summary Reports
Title Final Comprehensive Report: FC 95
Laboratory or Author
3M Env. Lab
Completion Date
3/15/79
Type
PmbustSmmary. Oommwft hA., swom k 800 ftm MSU &W FinalReW
Environmental Monitoring Part 1: Multi-City Study
Title
Design and Structure of Mufti-City Study
Low Level Drinking Water Analytical Method Fluorochemical Characterization of Drinking Water Samples. Columbus, GA (W2336)
Fluomchemical Characterization of Drinking Water Samples. Pensacola, FL (W2176)
Fluomchemical Characterization of Drinking Water Samples. Pon
St.LucieF,L (W2363)
Fluorochemical Characterization of Drinking Water Samples. Decatur,Alabama (WI979)
Fluorochemical Characterization of Drinking Water Samples.
MobileA,labama (W2151)
Fluorochemical Characterizatioonf DrinkingWater Samples.
Cleveland, Tennessee (Wl973)
Draft Drinking
r Health Advisory (DWHA) - PFOS
BattelleField Sampling Procedures Review. Columbus Georgia
City Survey regarding Empirical Human
Multi-CitSytudy
Exposure Assessment.
'gufti-CityStudy. Field Report for Cleveland Tennessee and Decatur Alabama - Battelle Duxbury Activities
Mufti-CityStudy. Field Repprt for Columbus Lucie Florida - Battelle Duxbury AEfivities
Georgia and Port St.
Final Multi-CityStudy. Field Report for Mobile Alabama and Pensacola Florida - Battelle Duxbury Activities
Quality assurance Project Plan for Empirical Human Assessment. Multi-Cky Study Sampling Task
Exposure
Amendment I to the Quality Assurance Project Plan and Associated SOP's
Laboratory or
Author
Battelle Memorial Institute
Completion
Date
511/00
3M Env. Lab Centre Analytical Laboratories, Inc. Centre Analytical Laboratories, Inc. Centre Analytical
Laboratories,Inc.
Centre Analytical Laboratories, Inc. Centre Analytical
Laboratories,Inc. Centre Analytical
Laboratories, Inc. 3M Corporate
Toxicology
3M Env. Lab
4/2&W 2/29/00 2/28/00 2/28/00 2/28/()o 2/28/00
2/28/00
717/99 8/3199
Battelle Memorial Institute
Battelle Memorial Institute
Battelle Memorial Institute
Battelle Memorial Institute
Battelle Memorial Institute
7/g/99 10126199 9/29/99 5114/99 6/16199
Type Report Medvd FinaRlepon FinalReport FinalReport FinaRleport FinalReport FinalReport Report FinalReport
FOW Report FinalReport FinaRleport
AmmorKknwvt
Part2: BlosphereStudies
Title
LCMSMS Analysis of ExtractsReported in: "PreliminaryReport Analysis of Perfluodnated Compounds inEnvironmental Samples"
Laboratoryor Author
Michigan State University(P. Jones
and K. Kannan)
Completion Date
4/7/99
Type Repon
,AnalysisoCFiuo-rochemical3inWild Bird Livers
[ScreenionfgPFOS levelisnEagle-anAdlbatross
3M Env.Lab
3M Env. Lab
4/2&99
S/SM
FkmiRepod
Repon
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctaSnuelfonatSetudies
AcuteToxicity
1) An Acute bmation ToxicityStudyof T-2306 CoC intheRat,Bio/dynamicsI,nc., ProjectNo. 78-7185,December 31, 1979. (FC-95,PerfluorooctanSeulfonate potassiumsalt)
2) Acute OralToxicity(LD50) StudyinRatswithFluoradgFluorocheniicaSlurfactant FC-95, InternationRaelsearchand Development Corporation,ProjectNo. 137-083, May 31, 1978. (Note:3M filesindicatseamplestakenduringthestudywere not analyzed.)
3) Eye and SkinIrritatioSntudiesReport on Sample T-1166 (FC-98,Potassium PerfluoroediylcyclohexSyullfonatep,resumed 100 Warf InstitutIenc.,Project No. 5011023, January28, 1975.
a) Combined Eye and SkinIrritatiSotnudiesReport
b) Eye IrritatiSotnudy(withwashoutprocedure)Report
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctaSnuelfonatgetudies
Genotoxicity
1) MutagenicityEvaluationof T-2014 CoC intheAmes Salmonena/Microsome Plate TestFinalReport,LittonBioneticsProjectNo. 20838,ProtocolNo. DMT-100, February20, 1978.
2) Memorandum Reportfrom S. R. RohfingtoA. N. Welter,datedMarch 31 1977, on Resultsof theAmes Spot TestforMutagenicityscreeningof variousFCs, includingSample 12-583which isFC-95, Notebook Reference45867-24,25.
3) MutageniciTteystonT-6295inaninvivoMouseMicronucleAusssay,Final Report,Coming Hazleton,Inc.(CHV), CIFIStudyNo. 17403-0-455,May 23, 1996, and protocoland amended protocol.
4) FinalReport,Chromosomal AberrationsinHuman Whole Blood Lymphocytes with .PFOS,Covance LaboratoriesI,nc.,Covance StudyNo. 20784-0-449,3M ReferenceNo. T-6295.18,October25, 1999.
5) FinalReport,UnscheduledDNA SynthesisinRat LiverPrimaryCellCultureswith PFOS, Covance LaboratoriesI,nc.,Covance StudyNo. 20784-0-447,3M ReferenceNo. T-6295.19,November 9, 1999,and protocol.
6) FinalReportS,almonella-Eschefcioclhii/aMammalian-MicroRseovmeerse MutationAssay with PFOS, Covance LaboratoriesI,nc.,Covance StudyNo. 20784-0-409,3M ReferenceNo. T-6295.17,November 5, 1999,and protocol.
7) FinaRleportI,nVitrMoicrobiologiMcuatlageniciAtsysayosf3M Company Compounds T-2247.CoC and T-2248 CoC, SRI InternationaSlR,I ProjectNo. LSC-4442-016,3M Refemece No. T-2247.1 (FC-99 Old Formula,L-4299 which is 50 % ofthediethanolaminesaltofperfluorooctanesulfoniantweater),September5, 1978.
8) Prof.NicolaLoprieno,"Evaluationof MutagenicityStadiesDeveloped on (PFOS) PerfluorooctanSeulfonate",preparedattherequestof John L. Butenhoff,Ph.D., 3M CorporateToxicology,January,2000.
9) FinaRlepor-t BacteriRaelversMeutatioAnssayOf T-1, HitaResearch LaboratoriesC,hemical BiotestinCgenter,Study Code K01-1802, 3M Reference No. T-6667.1 (FC-98,PotassiumPerfluoroethylcyclohexSyulfonate)S,eptember, 1996.
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluorodanSeulfonatSetudies
Repeated-DoTsoexicity
1) Ninety-DaySubacuteRhesus Monkey ToxicityStudy,withFluorad's FluorochemicalSurfactantFC-95, InternationaRlesearchand Development Corporation,ProjectNo. 137-092,December 18, 1978.
a) StudyReport
b) AbortedStudy:Ninety-DaySubacuteRhesusMonkey ToxicityStudy,with FluoradgFluorochemicalSurfactanFtC-95, InternationRaelsearchand Development Corporation,ProjectNo. 137-087,January2, 1979.
2) Ninety-DaySubacuteRat ToxicityStudy,withFluorad*FluorochemicalSurfactant FC-95, InternationRaelsearchand Development Corporation,ProjectNo. 137-085, November, 1978.
3) 104-week DietaryChronicStudy and CarcinogenicitSytudy withPerfluorooctane SulfonicAcid PotassiumSalt(PFOS: T-6295)inRats,Covance LaboratorieIsnc., StudyNumber 6329-183. Inprogress.
a) Summary Report- Week 53 undated
b) "LiverSlideReview," Marvin Case toJohn Butenhoffand Andrew Seacat datedApril5, 2000 relayingtheresultsof an independenthistopathologic reviewof liverslidesfrom thestudy.
c) Second DraftCellProliferatioRneport,PathologyAssociatesInternational, August24, 1999. [fmalinterimreport,tobe incorporateidnfmalreport]
d) StudyReportofDeterminationofCyanide InsensitivPealmitoyl-CoAoxidation in samplesfrom 3M EnvironmentalLaboratory- Covance Studies6329-183 and 6329-212,CentreFor XenobioticResearch,Universityof Dundee, Biomedical ResearchCenter,Study Number XR0108, February 18, 1999.
4) Range-finder4:-Week CapsuleToxicityStudywithPerfluorooctanSeulfonicAcid PotassiumSalt(PFOS; T-6295)inCynomolgus Monkeys, Covance Laboratories Inc.,StudyNumber 6329-222
a) UnauditedDraftFinalReport,4-Week CapsuleToxicityStudywith PerfluorooctanSeulfonicAcid PotassiumSalt(PFOS; T-6295) inCynomolgus Monkeys Covance LaboratoriesInc.,StudyNumber 6329-222(draftnot complete).
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctSaunlefonatSetudies
b) CellProliferatiRoenport,4-Week Capsule ToxicityStudywithPerfluorooctane SulfonicAcid PotassiumSalt(PFOS; T-6295) inCynomolgus Monkeys, Covance LaboratorieIsnc.,StudyNumber 6329-222 (draftobe incorporated infmalreport)
c) Protocol- AnalyticaSltudy,QuantitativAenalysisofPerfluorooctanSeulfonic Acid PotassiumSalt(PFOS; T-6295)inCynomolgus Monkeys Following Administratioonf a 4-Week CapsuleToxicityStudy,3M Environmental Laboratory,AMDT-041598.1
d) Memorandum from Marvin Case,regardinghistopathologryeviewof liver tissueinCovance Study 6329-222,July27, 1998
5) 26-Week CapsuleToxicityStudy withPerfluorooctanSeulfonicAcid PotassiumSalt (PFOS: T-6295) inCynomolgus Monkeys, Covance LaboratorieIsnc.,Study Number 6329-223. Inprogress.
a) Undated reportcoveringthe26-week dosingphaseand one yearof recovery.
b) JohnButenhoff,"Dose-SettinRgationaleforSix-MonthChronicOralStudyin Cynomolgus Monkeys," datedJuly29, 1998 and foflowupAug. 3, 1998.
c) FecalUrobilinogenAnalysis,Mayo ClinicP,orphyrinsand Nutritional ChemistryGroup, TestCode: 8308.
i) Summary Reportfrom Dr. JosephP. McConnell,datedMarch 16,1999.
ii)Generalinformatiofnrom Mayo ClinicP,orphyrinsand Nutritional ChemistryGroup on UrobilinogenAnalysis,datedJanuary14, 1999.
iiiI)ndividuaalniinaulrobilinogelnabreports(rawdata)from Mayo Clinic, Porphyrinsand NutritionaClhemistryGroup.
d) PathologyReport(AncillarSytudy),ElectronMicroscopicEvaluationofLiver in Cynomolgus Monkeys, PathologyAssociatesInternationaSlt,udy No. EM99.76, July13, 1999.
e) PathologyReview, Marv Case to Andrew Seacat,datedJuly22, 1999 relaying theresultosf a histopathologryeview of slides.
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctSaunlefonatSetudies
f) LaboratoRreyportI,nteriRmeportofPreliminaDraytafor26Week Capsule ToxicologyStudy withPFOS inCynomolgus Monkeys, 3M Environmental Laboratory,ReportNo. FACT-TOX-030, datedMarch 29, 1999.
6) Two Week OralRangefmding ToxicityStudyofT-2509CoC inRats, Safety EvaluationLaboratory,RikerLaboratoriesI,nc.,ExperimentNo. 179RRO23, 3M Referencen-o. T-2509.3 (FC-99 New Formula, L-4509,25 % diethanolaniinsealt .ofperfluorooctanesulfoniantweater),February25, 1980.
7) [Submitteudnder claimof Confidentiality]
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctaSnuelfonatSetudies
PharmacokineSttiucdies
1) SkinAbsorptionStudieson Surfactant(s1983)
a) Reportfrom W. C. McCormick toD. R. Ricker,datedSeptember26, 1983 summarizing data
b) 28 Day PercutaneousAbsorptionStudyin Rabbitswith FC-95, Safety EvaluationLaboratory,RikerLaboratoriesI,nc.,ExperimentNo. 0979ABO632 (FC-95)
c) 28 Day PercutaneousAbsorptionStudy inRabbitswithFC-99, Safety EvaluationLaboratory,RikerLaboratoriesI,nc.,ExperimentNo. 0979ABO633, 3M ReferenceNo. T-3988.1(FC-99, diethanolaminsealtof perfluorooctanesulfonaatses,umed to be 25 % in water)
2) Single-DoseIntravenousPharinacokinetiSctudyofT-6053 inRabbits,3M EnvironmentalLaboratory(FC-99,dieflmolaminesaltof perfluorooctanesulfonate m waterLot 130,Unit 177.0.04 % FC solidsinwater),November 16,1995. FinalReport- AnalyticaSltudy,which includescopy of invivoStudyNo. AMDT010495.1,HazletonWisconsin,Inc.,ProjectNo. HWI 6329-136,3M Reference No. T-6053.1
3) Single-DoseDermal Absorption/ToxicityStudyofT-6053 inRabbits,3M EnvironmentalLaboratory,Study No. AMDT-022195. 1,(FC-99,diethanolamine saltofperfluorooctanesulfoniantweaterLot 130,Unit 177.0.04 % FC solidsin water),November 22, 1995. FinalReport - AnalyticaSltudy,includesinvivo Study HazletonWisconsin,Inc.,ProjectNo. HWI 6329'-1373,M ReferenceNo. T6053.2
4) Fluorochemical(FC) LevelsinNaYve Rats,3M MedicalDepartment,Toxciology ServicesS,tudy No. T-6316.9,DT21, DraftReportforObjective3,May 14, 1999.
5) AnalyticaDlata submittedtoDr. JenniferSeed,USEPA, by lettedratedMay 3, 2000, includingsenun measurementsfrom two in-lifsetudies:
a) Analyticadlatafrom Advanced BioanalyticaSlervicesStudyNo. FACT-TOX111,with respecttoOral (Gavage)PharmacokineticRecovery Study of PerfluorooctanSeulfomte in Rats,Argus LaboratoriePsrotocolNo. 418-015, 3M ReferenceT-6295.14.
AttachmenttsoLettetroC.Auer datedMay 4,2000 PerfluoroctSaunlefonatSetudies
b) AnalyticdaaltafromAdvancedBioanalytiScearlviceSstudyNo.FACT-TOX110.,withrespecttoOral (Gavage)PharmacoldneticStudy ofPerfluorooctane SulfonateinRats,Argus LaboratoriePsrotocolNo. 418-013,3M ReferenceT6295.12.
6) InVitroComparativeMetabolism StudyinRat and Human Hepatocyteswith VariousFluorochemicals3,M ReferenceT-6295.1,studyof T-6292 (N-ethyl FOSE), T-6293 (N-ethylFOSE monophosphate ester)T,-6294 (N-ethyl perfluorooctanseulfonamide)a,nd T-6295 (PerfluorooctaSnuelfomte)
a) Range-findingCytotocitAyssay,SRI InternationTaolxicologyLaboratory, Study No. B01 0-95 - protocoland faxedresultsdatedOct.26, 1995,Dec.12, 1995, and Jan.16, 1996
b) MetabolismofT-6292,T-6293 ,T-6294, T-6295 by Rat and Human Hepatocytes,SRI InternationTaolxicologyLaboratory,StudyNo. BO 11-95
c) Advanced BioanalyticaSlervicesI,nc.,AnalyticaRleport,Additional Characterizationf Metabolitesof T-6292,T-6293 and T-6294 from Rat and Human Hepatocytesby TurboIonSprayLC/MS and LC/MS/MS. SemiQuantitativAenalysisof T-6295 inRat and Human HepatocytesIncubatedwith T-6292,T-6293 and T-6294 by LC/MS/MS, January28, 1998,Report 98AGKPO1.3M
d) Working InterpretatiofnResults,chartentitlePderfluorosulfonamide Metabolism inRat vs.Human Hepatocytes,updatedFeb. 5, 1998 based on ABS Jan.1998 report
AttachmenttsoLettetroC.Auer datedMay 4,2000 PerfluoroctSaunlefonatSetudies
Mechanistic
1) Reportsfrom UniversityofMinnesotaDuluthResearch(KendallWallace):
a) KendallB. Wallace,Biochemicaland MolecularMechanisticStudiesofN-Alkyl PerfluorosulfonamideRse,searchProposal,April8, 1997,and Updated ProposalMay 7, 1998
b) KendallB. Wallace and AnatoliStarkov,The EffectofPerfluorinated Arylalkylsulfonamidoens BioenergetiscofRat LiverMitochondria,Feb. 4, 1998
c) Report on Covance Studies,assessmentofmitochondrialbioenergeticsu,ndated
d) Summary oftheEffectsof PFC's [PerfluorinatCeodmpounds] on Mitochondrial BioenergeticIsn Vitro,undated
e) Report,Effectsof SelectedPerfluoro-compoundson MitochondrialBetaOxidation,Dec. 20, 1999
f)Report,Effectof Acute FC Administratioonn Catalaseand acylCoA Oxidase Expression,January27, 2000
2) Nabbefeld,etal.,Displacementofa FluorescentlLyabeledFattyAcid Analogue fromfattyAcid CarrierProteinsby Wyeth - 14,643,Ammonium PerfluorooctanotatPeo,tassiumPerfluorooctanSeulfonateand Other Known PeroxisomeProliferatorAsb,stract,SocietyofToxicology,1998 Annual Meeting
Attachments toLetterto C. Auer datedMay 4,2000 PerfluoroctaneSulfonateStudies
Teratology PilotTeratologyStudy inRats,T-3551 FinalReport,May 13, 1983,3M ReferenceT3551.12
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctSaunlefonatSetudies
Human Sera/MedicSaulrveillance/Epidemiology
Memorandum from D.E. Roach and S.D. Sorenson,1983 DecaturBlood Fluoride Review, January20, 1984
Antwerp Blood TestingResultsfrom June 1995,by JeffreyH. Mandel, M.D., M.P.H., and JeanBurris,R.N., O.H.N., M.P.H., November 6, 1995
Analysisof Serum ValuesinDecaturWorkers, preparedby Michel Burlew forLarry Zobel,M.D. andJeffreyMandel, M.D., April2, 1998
LaboratoryReport,AnalysisofFCs inSamples ofChildren'Ssera,LaboratoryReport No. FACT-GEN-011, 3M EnvironmentalLaboratory,May 21, 1999
LaboratoryCompositeReport,AnalyticaRleportsofData forFluorochemicalAnalysis inHuman Sera,IJMS No. 1623,3M EnvironmentalLaboratory,April28, 2000
ATTACIUAENT TO LETTER TO C.AUER DATED MAY 4,2000:ONGOING ENVIRONMENTAL STUDIES ON PERFLUOROOCTANESULFONATES
P@ysical/ChemPircoaplerties
PotentiaFlluorochemicalCombustion By-Products(involvesreviewof resultosf literature searchregardingpotentiaflorformationof florindateddioxinsand furans)3,M Environmental Laboratory.Expectedcompletion:Sept.2000. Studypaperinprogress.
FluorochemicalDecompositionProcess:Quantificatioannd Assessment(involves computationalchemistrycalculationosf bond-breakingstrengthosf sulfonated perfluorochemicalsB)a,ttellMeemorial InstituteE.xpectedcompletion:Aug. 2000. Study paperinprogress.
EnvironmentalFateand Transpo
AbioticDegradationStudies(hydrolysiasnd indirecpthotolysis3)M, Envirom-nentaLlaboratory. Expectedcompletion:June2000 (hydrolysisA)u;g. 2000 (indirecpthotolysis)(.Summary study planand screeningresultsummary beingprovidedtoEPA)
BiodegradationStudies(aerobicacclimatedclosedbottlebiodegradationa,erobicsoil/sediment biodegradationp,ure cultureaerobica,nd fluorochemicadlecompositionprocess,stabilitiyn water,photodegradation)S,pringbom LaboratoriesI,nc.Expectedcompletion:Aug. 2000. (Summary studyplanbeingprovidedtoEPA)
EcotoxicitEylements
PFOS: A 96-Hour ToxicityTestwiththeFreshwaterAlga (Anabaenaflos-aquae)W,ildlife InternationaLlt,d. Expectedcompletion:July2000. (ProtocobleingprovidedtoEPA)
PFOS: A 96-HourToxicityTestwiththeFreshwater
Diatom (Naviculapelliculosa),
Wildlife
InternationaLlt,d. Expectedcompletion:*July2000. (ProtocobleingprovidedtoEPA)
PFOS: A 96-HourToxicityTestwiththeMarineDiatom (Skeletonemacostatum)W,ildlife InternationaLlt,d. Expectedcompletion:July2000.(ProtocobleingprovidedtoEPA)
PFOS: A 7-Day ToxicityTestwithDuckweed (Lemna gibba),WildlifeInternationaLlt,d. Expectedcompletion:July2000. (ProtocobleingprovidedtoEPA)
Phytotoxicit-ySeedlingEmergence,WildlifeInternationaLlt,d. Expectedcompletion:July 2000. Protocolin progress.
Envirom-nentaMtonitoring
GlobalEnvironmentalSamplingPlan,Michigan StateUniversityE.xpectedcompletion:Dec. 2000. (Summary beingprovidedtoEPA)
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctaSnuelfonatSetudies
OngoingResearch/StPurdoytocols
1) 104-week DietaryChronicStudy and CarcinogenicitSytudywithPerfluorooctane SulfonicAcid PotassiumSalt(PFOS: T-6295)inRats,Covance LaboratoriesInc., Study Number 6329-183. Inprogress.Interimdataprovided.
2) 26-Week CapsuleToxicityStudy withPerfluorooctanSeulfonicAcid PotassiumSalt (PFOS: T-6295)inCynomolgus Monkeys, Covance LaboratorieIsnc.,Study Number 6329-223. Inprogress.Interimdataprovided.
3) ProtocolforStudy: Low LevelPFOS Dose versusRat Serum and LiverPFOS, 3M MedicalDepartment,CorporateToxicology,StudyNo. T-6295.16DT3 1,October 29, 1998.(Studyinprogress.)
4) ProtocolforStudy: PharmacokineticStudy ofPOSF inRats,3M Medical Department,CorporateToxicology,ProtocolforStudyNo. T-7098.1,January7, 1999.(Studyin Progress).
5) StudyPlan,ST-43:StandardProcedureforLiverSubellulaFrractiomtionu,ndated, 3M ToxicologyLaboratory
6) Plan for Study Nos. T-6295.23;ST-46,ExploratoryIn-VitroPervutaneous AbsorptionStudy of TheophyflineS,alicyliAccid,Perfluorooctylsulfomtaen,d Ammonium PerfluorooctanoatienSkinEthicReconstituteEdpidermisModel, May 4,2000,3M ToxicologyLaboratory
7) StudyPlan,Luebker,PerfluorooctanSeulfonicAcid InducedHMG-COA Reductase InhibitioinnPregnantRats and Rat Pups, January21, 2000
ATTACHM[ENT TO LETTER TO C. AUER DATED MAY 4,2000:PLANNED ENVIRONMENTAL STUDIES ON PERFLUOROOCTANESULFONATES
EnvirorunentFaalteandTranspo
SoilAdsorption/Desorption3,M EnvironmentalLaboratory.Startdate:May 2000. Protocolin progress.
Multi-MediaModeling ofPFOS DistributioMna,ckay, D. (TrentUniversity)Startdate:June 2000. Protocolinprogress.
BioconcentratioFnactor,WildlifeInternationaLlt,d. Startdate:Sept.2000. Protocolin progress.
EcotoxicityElements
Acute Toxicityto BluegillSunfish,WildlifeInternationaLlt,d. Startdate:July2000. Protocol inprogress.
Acute Toxicityto Sheepshead Minnow, WildlifeInternationaLlt,d.,Startdate:July2000. Protocolin progress.
Phytotoxicit-y VegativeVigor and Plan Uptake, WildlifeInternationaLlt,d. Startdate:June 2000. Protocolinprogress.
Acute ToxicitytoEiseiniafoetid(aEarthworms),WildlifeInternationaLlt,d. Startdate:June 2000. Protocolinprogress.
FETAX (FrogEmbryo Teratogenesis)W,ildlifeInternationaLlt,d. Startdate:June 2000. Protocolinprogress.
MallardDuck Reproduction(Dietary)W,ildlifeInternationaLlt,d. Startdate:July2000. Protocolin progress.
Bobwhite Qu-ailRepr6duction(Dietary)W,ildlifeInternationaLlt,d. Startdate:July2000. Protocolin progress.
EnvironmentalMonitoring(EnvironmentalSampling & ReleaseEstimation)
EstimationofPFOS inLife-CycleWaste Streams,BattelleMemorial. Startdate:May 2000. Protocolin progress.
Estimationof Life-CycleReleases,BattelleMemorial InstituteS.tartdate:January2001. Protocolin progress.
CarpetReleaseStudy,BattellMeemorial InstituteS.tartdate:June2000. Protocolinprogress. Multi-CityStudy,CentreAnalyticaLlaboratoriesI,nc.;3M EnvirorunentaLlaboratory.Start date:June2000. (StudyplanbeingprovidedtoEPA)
Multi-CityStudy- Analysesof Sediments.Startdate:June 2000. Multi-CityStudy - AnalysesofWater Colurims.StartDate: Sept.2000. Multi-CityStudy- AnalysesofSurfaceWater Film. Startdate:Sept.2000. Multi-CityStudy- AnalysesofPOTW Effluenm Startdate:Sept.2000. Multi-CityStudy- AnalysesofPOTW Sludge.Startdate:June2000. Multi-CityStudy - AnalysesofLandfilLleachates.Startdate:Sept.2000. Multi-CityStudy- AnalysesofFish.Startdate:June2000. Multi-CityStudy- Analysesof"Market Baskets."Startdate:June2000.
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctSaunlefonatSetudies
PlanneSdtudies
1) PreliminaryStudy Outline,One GenerationReproductionStudy ofPFOS inRats, PharmacokineticAnalysis,May 3,2000
2) PreliminaryStudy Outline,One GenerationReproductionStudy of PFOS in Rats, MevalonicAcid/CholesteroClhallengeand NOEL InvestigatioinRats,April27, 2000
ATTACEMNT TO LETTER TO C.AUER DATED MAY 4,2000: PRE-1976ENVIRONNENTAL STUDIES ON PERFLUOROOCTANESULFONATES
Data from FatheadMinnow Study on FC-93 (25% NH4 saltofPFOS inIPA and water),3M EnvirorunentaLlaboratory,Aug. 2, 1974. (Robustsummary, MSDS and copiesofdatabeing providedto EPA)
Data from FatheadMinnow Study on FC-93 (25% NH4 saltofPFOS inIPA and water),3M EnvirorunentaLlaboratory,Oct. 19,1974. (Robustsummary, MSDS and copiesof databeing providedtoEPA)
BOD/COD resultfsorFC-93 (25% NH4 saltofPFOS inIPA and water),3M Environmental Laboratory.Completiondate:July 18,1974. (Robustsummary and copy ofresultbseing providedto EPA)
ATTACHM[ENT TO LETTER TO C. AUER DATED MAY 4,2000: PRE-1976 TOXICOLOGY STUDIES ON PERFLUOROOCTANESULFONATES
Eye and Skin IrritatiSotnudiesReporton Sample T- 1117,Warf InstitutIenc.,ProjectNo. 410287 1,November 7, 1974,and explanatorycorrespondenceindicatinmgaterialisFC-95 (PerfluorooctanSeulfonatepotassiumsalt)
Eye, Skin and Acute Dermal LD50 StudyReporton Sample T-991 (FC-93,L-3356,Ammonium SaltofPerfluorooctanSeulfonate2,5% in20% IsopropylAlcoholand 55% Water),Warf InstitutIenc.P,rojectNo. 4053862, June 25, 1974
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctSaunlefonatSetudies
BibliograpohfAycuteToxicitSytudieNsotSubmitted
1) Acute OralToxicity-Ratosn Sample T-1389,BiosearchInc.,March 4, 1976 (FC95, PerfluorooctanSeulfonate'potassiusmalt).
2) Acute Oral Toxicity-Ratosn Sample T-1390,BiosearchInc.,March 4, 1976. [FC98]
3) Acute Oral Toxicity-Ratosn Sample T-2297 CoC (Ammonium Perfluorooctane SulfonateF,C-93 Solids)B,iosearch,Inc.October13, 1978.
4).Acute Oral Toxicity-Ratosn Sample T-2275 CoC (FC-99 Old Formula,L-4299, NB 48490, which is50 % oftheDiedmolamine Saltof PerfluorooctanSeulfonate inwater),Biosearch,Inc.,September25, 1978.
5) Primary SldnIrritatiToenstwith T-2509CoC inAlbinoRabbits,SafetyEvaluation Laboratory,RikerLaboratoriesI,nc.,ExperimentNo. 479EB0332, 3M Reference no.T-2509.4(FC-99New Formula,L4509, 25 % Diedmolamine Saltof PerfluorooctanSeulfonatein water),June 28, 1979.
6) Acute OcularIrritatiSotnudywith T-2509CoC inAlbinoRabbits,SafetyEvaluation Laboratory,RikerLaboratoriesI,nc.,ExperimentNo. 479EB0333, 3M Reference no.T-2509.1(FC-99New Formula,L-4509,25 % DiethanolamineSaltof PerfluorooctanSeulfonateinwater),July13, 1979.
7) Acute InhalatioTnoxicityStudy ofT-2308 CoC intheRat,Bio/dynamics,Inc., ProjectNo. 78-7187,3M ReferenceNo. T-2308 (FC-98,Potassium PerfluoroethylcyclohexSyulfonatep,resumed 100 %), April12, 1979.
8) Acute OcularIrritatiToenstwithT-2960CoC inAlbinoRabbits,SafetyEvaluation Laboratory,RikerLaboratoriesI,nc.,ExperimentNo. 0880EB0598, 3M Reference No. T-2960.2 (FC-90,L-4649, DiethanolamineSaltofPerfluoroethylcyclohexyl Sulfonate2,5 % inwater),February18, 1981.
9) Acute Demul ToxicityStudywith T-296OCoC inAlbinoRabbits,SafetyEvaluation Laboratory,RikerLaboratoriesI,nc.,ExperimentNo. 0880ABO599, 3M Reference No. T-2960.1(FC-90,L-4649, DiethanolamineSaltofPerfluoroethylcyclohexyl Sulfonate2,5 % inwater),January15, 1981.
10)PrimarySkin IrritatiToenstwithT-296OCoC inAlbinoRabbits,SafetyEvaluation Laboratory,RikerLaboratoriesI,nc.,ExperimentNo. 0880EB0597, 3M Reference
AttachmenttsoLettetroC. AuerdatedMay 4,2000 PerfluoroctaSnuelfonatSetudies
No.T-2960.(4FC-90L,-4649D,iethanolamSianletofPerfluoroethylcyclohexyl Sulfonate2,5 % inwater),January15, 1981.
11)Acute Oral ToxicityStudywithT-296OCoC inAlbinoRabbits,SafetyEvaluation Laboratory,RikerLaboratoriesI,nc.,ExperimentNo. 0980AR0600, 3M Reference No. T-2960.3(FC-90,L-4649,DiethanolamineSaltofPerfluoroethylcyclohexyl Sulfonate2,5 % inwater),February18, 1981.
12)Acute OralToxicity- Rats,Biosearch,Inc.,3M ReferenceNo. T-2296 (FC-93, Ammonium PefluorooctanSeulfonate2,5 % in20 % IsopropylAlcoholand 55 % Water),October 19, 1978.
ATRACEMNT TO LETTER TO C.AUER DATED MAY 4,2000:PUBLISHIED STUDIES ON PERFLUOROOCTANESULFONATES
EnvironmentSatludies
Key,B.L.H;owellR,.D.;CriddlCe.,S."FluorinaOtregdanicisnthej3iospherEen,v"i'romSci. Technol1,997,31:2445-2454
Key, B.L.;Howell,R.D.;Criddle,C.S."DefluorinatioonfOrganofluorinSeulfurCompounds by Pseudomonas Sp.StrainD2," Fnvirom Sci.Techngl,1998,32:2283-2287
ToxicologyStudies
BelisleJ,Hagan DF (1978).Anal Biochem. 87,545 (NoteError:Inthisreportheblankwas erroneouslryeportedas 0.02mg; itshouldbe 0.02pg.)
BelisleJ,(1981).Science212,pp. 1509-1510.
Guy, WS (1972).Ph.D.Thesis,UniversitoyfRochester,RochesterN,Y.
Guy, WS, Taves,DR, Brey,Jr.,WS (1976).Organicfluorocompoundsinhuman plasma: prevalenceand characterizatio(nI.n)BiochemistryInvolvingCarbon-FluorinBeond, pages 117134.
Haughorn, B. and Spydevold,0. 1992. The mechanism underlyingthehypolipemiceffectof perfluorooctanoaiccid(PFOA), perfluorooctanseulphonicacid(PFOSA) and clofibriacid. Biochim. Biophys.Acta.1128,65-72.
Ikeda,T.,Fukuda,K.,Mori,I.,Enomoto, M., Komai, T. and Suga,T. 1987. Inductionof cytochromeP-450 and peroxisomeproliferatiionratliverby perfluorinateodctanesulfonic acid.In:PeroxisomesinBioloSyandme&cine, RD. Fahimiand H. Sies,Eds. SpringerVerlag, New York 304-308.
Johnson,J.D.-Gibsor@S.J.and Ober, R.E. 1984. Cholestramine-enhancedfecaleliminationof carbon-14in;a;safteradministratioonf ammonium (14C]perfluorooctanoaotrepotassium [14C]perfluorooetanesulfonaFtuen.d AppL Toxicol4, 972-976.
NabbefeldD.,ButenhoffJ.,Bass N. and SeacatA- 1998.Displacementof a fluorescentllyabeled fattyacidanaloguefrom fattyacidcarrieprroteinsby wyeth-14,643,ammonium perfluorooctanoatpeo,tassiumperfluorooctanseulfonateand otherknown peroxisome proliferator(sS.OT AbstractA.ccepted, Toxicologis1t998).
Olsen,GW, Burris,JK Mandel, JH and Zobel,LR (1999). Serum perfluorooctanseulfonateand hepaticand lipidclinicaclhemistrytestsinfluorochemicaplroductionemployees. JOEM 41:799-805.
PothapragadaV, (1975).Determinationoftotalfluorinienserum and otherbiologicamlaterials by oxygen bomb and reverseextractiotnechniques.AnalyticaBliochem 68:512-521.
PothapragadaV, Singer1;@Armostrong WD (1971).Determinationofionic(plusionizable) fluorideinbiologicaflluids.Procedurebasedon adsorbptionof fluorideionon calcium phosphate.Anal Biochem 42:350-359.
SingerL and Armstrong WD (1959).Determinationoffluoridienbloodserum. Analytical Chem 31:105-109..
SingerL and Ophaug RH (1979).Concentrationosfionic,totala,nd bound fluoridienplasma. ClinChem 25:523-525.
Sohlenius,A-K.,Eriksson,A-M., Hbgstrbrn,C.,Yjmland,M. and DePieffe,J.W. 1993. Perfluorooctanseulfonicacidisa potentinducerofperoxisomalfattyacidB-oxidationand other activitikensown to be affectedby peroxisomeproeferatorisnmouse liver.Pharmacol. Toxicol. 72,90-93.
Taves D (1968a).Evidencethattherearetwo formsoffluoridienhuman serum. Nature 217;1050-105 1.
TavesD (1968b).Electrophoretmiocbilityofserum fluorideN.ature220:582-583.
Taves D, Guy W, Brey W (1976).Organicfluorocarbonisnhuman plasma: Prevalenceand characterizatioInn.: FilleRr, eds.BiochemistryInvolvingCarbon-FluorinBeonds. Washington,DC:American Chemical Society,pages 117-134.
Ubel FA, Sorenson SD, Roach DE (1980).Healthstatusofplantworkersexposedto fluorochemicalsa,preliminarryeport.Am IndHyg Assoc J. 41;584-589.
Yamamoto G, YoshitakeY.,SatoT,Kimura T and Ando T (1989).Distributioannd forms of fluorinienwhole blood ofhuman male. AnalyticaBliochem 182:371-376.
PHYSICAL - CHEMICAL PROPERTI[E
A Robust Summary, FinalReport, and Protocolon the physical-chemicaplropertiesof perfluorooctanesulfonataere includedforeach of the followingparameters:
PARAMETER
DATE OF REPORT
Melting Point/MeltingPointRange Vapor Pressure
n-Octanol/Water PartitionCoefTicient Air-Water PartitionCoefficient Solubilitiyn pure water SolubilitMyeasurements on FC-95
2/24/99 5/5/99 2/11/00 3/19/00 5/3/99 2/6/81
RESULTS
4000C 3.31x 10'P@200C Not calculable;three phases 0(<2xlO-) 570mg/i 1080mg/i
The data presentedin thestudy "SolubilitMyeasurements on FC-95," was determined by indirectmeasurement, not by actualanalysis.Therefore,the data isnot reliable.
Pleasenote thatthe March 1,2000 submittalto EPA entitled"Sulfonated Perfluorochemicalsin the Environment Sources,Dispersion,Fate and Effects"included solubilitdyata on water otherthan pure (:ie.f,reshwater; filteresdea water; unfilteredsea water).These data were developed,however, in support ofother studiesand not produced using GLP Standards.For thisreason,Robust Summaries, FinalReports,or protocolsfor thisspecificdata are not being provided.
ENVIRONMENTAL
FATE AND TRANSPORT
This sectionpresentsinformationand testresultsfrom abiotic,and bioticdegradation and soiladsorptionstudies.Degradation studiesincludehydrolysisp,hotolysisa,nd biodegradation.Much of thiswork isin progresswith rinalreportsscheduledforthe June toAugust, 2000 timeframe.
As these studiesprogress,thereare certainkey rindingsthat can be presentedas preliminaryresults:
1.There has been no indicationthatperfluorooctanesulfonatuendergoes any degradationfrom hydrolysis,photolysiso,r biodegradationmechanisms.
2. In allhydrolysisand photolysisstudies,perfluorooctanesulfonatheas not been detectedas a degradation product in any conclusiveexperiment.This preliminary rindingcallsintoquestionthe assumption of expect.-degrada*.ionof other fluorochemicalsto.perfluoroctanesulfonate.
3. In the studiesfocusedon hydrolysisof fluorochemicalpolymers thatform the structureof the specificindustrialand consumer products,ithas been determined thatthesematerialsare relativelsytablein the environment. For example, the followinghalf-liveasre estimatedforvarious polymers:
POLYMER
HALF-LIFE
Acrylateand ester
1-5 years
Polyethyleneglycolbased
3-50 years
Urethane
>500 years
For hydrolysisto occur,polymers must be subjectedto an aqueous environment, which isnot expectedto occur in a municipal or industrialandfill.
4.Relativet-ophotolysis,the current data suggestsa hypothesisthat thesematerials willphotolyzeto carboxylatestructuresT.hese structureshave much different propertiesthen sulfonatesin thatthey are much lessbioaccumulativein ecological species.
Additionaldiscussionofthese resultsand ongoing studieswillbe presentedin subsequent submissions and reports.
ECOTOXICITY ELEMENTS
This sectionpresentsinformationand testresultsfrom a seriesof ecotoxicitsytudieson perfluorooctanesulfonateTsh.e informationispresentedas Robust Summaries, Final Report and Protocolforeach ecotoxiciteylement.
The studiesperformed during 1999 and in early2000 were carriedout using GLP Standards.In contrast,ecotoxicitsytudiesperformed during the period 1974 to 1998 were conducted usingprotocolsand analyticalmethodologiesavailableatthe time of thestudy. In addition,intheseoldertestst,he sulfonatedperfluorochemicalproductswere variable mixturesand contained more impurities.Severaltestswere hampered by the insolubilitoyf the perfluorochemicaland resultsare expressedas "greaterthan" the measured solubility. Therefore,the data presentedin thesehistoricarleportsmay not be reliable.
ENVERONMENTAL
MONITORING:
PART ONE - MULTI-Crff STUDY
The multi-citystudywas designedto obtainpreliminarydata about dispersionof fluorochemicalsin the environment, uptake intofoodsand presencein drinking water to understand the potentialsourcesof human and environmental exposures thatmight resultfrom thistype of dispersion.The multi-citsytudy paireda city having manufacturing or commercial use of fluorochemicalproducts based on customer saleswith a citythatdoes not. Initiallsyixcities(,threepairs)are being examined. The study may be expanded depending on furtherresults.
The multi-citystudywillyieldenvironmental distributiodnata as wen as data on potentialsourcesof human exposure. The citiewsere selectedto representurban locationswith variouslevelsoffluorochemicalreleasesand varioustypesof municipal water supplies.The samples to be obtained,where possible,include: urban air,surfacewater column and surfacemicrolayer,sediment,riverrish, drinkingwater intake,treateddrinkingwater,tap water,the influento and effluentfrom publicly-ownedwaste treatmentworks, sludge,and municipal landfill leachate.Additionallya, "market basket" ofseveralfood productswillbe sampled. These include: beef,pork, chicken,hot dogs, catrishe,ggs,milk,bread,green beans, applesfrom grocery storesand, ifpossible,produce from localfarmers' markets.
The attachedmaterialdata providesmore detailon the designand structureof the study and representsthe firstresultsfrom the multi-citystudy. Includedare reportson the qualityassurance plan and fieldsampling procedures used and the resultsof the drinkingwater samples taken from the sixcitiesT.he resultsindicate thatdrinkingwater in four citie(sDecatur,Alabama; Cleveland,Tennessee;Mobile, Alabama; and Port St.Lucie,Florida)did not containdetectablelevelsof fluorochemicals.Only two citie(sColumbus, Georgia,and Pensacola,Florida) contained detectablelevelsofsulfonatedfluorochemicalsin thedrinkingwater.The resultsshow thatthe levelsare in the range of 40-60 partsper trillioonf perfluoroctanesulfonate.Only one city,Columbus, Georgia,showed very low detectablelevelsof perfluorooctanoate.
Also includedisa copy of a draft"lifetime"drinkingwater healthadvisory developed forPFOS. This advisoryreflectas very conservativeapproach based on applicationof "safetyfactors."The advisorylevelof I part per billiosnhould not be misconstrued as thresholdfor danger or concern,but only a referencepointbased on applicationof conservativemethods and the informationavailableto date. A comparison of the drinkingwater data from the multi-citystudy indicatesthatthere are two orders of magnitude ofsafetybetween the draftdrinkingwater advisory and the resultsfrom thesetwo citieisn the multi-citsytudy.
ENVI[RONMMNTAL MONITORING: PART TWO - BIOSPHERE SAMPLING
AND ANALYSIS
A plantoassesspotentialenvironmentalexposuretoperfluorooctanesulfonaatned other fluorochemicalsubstanceshas been developedby 3M and outsideexperts.One component ofthisplan involvescharacterizatioonfthegeographicdistributioonffluorochemicalisn bioticand abioticreceptorsT.wo studiesare inprogress,one focusedinthevicinitoyfthe 3M Decatur,Alabama manufacturingfacilitayn,d theothera much more comprehensive globalbiospheremonitoringprogram. The preliminaryresultosbtainedtodatehave been reportedinthe3M Environmental White Paper entitle"dSulfonatedPerfluorochemicalisn the Environment: Sources,Dispersion,Fate and Effects."
The study intheDecatur,Alabama areaisbeingdesignedtounderstandtheimpact,ifany, of productionoperationsinthelocalenvironment.Samples ofthegroundwater,surface water,sedimentsand fishand birdspecieswillbe collecteidnMay and June,2000 for analyses.This data willbe used toevaluatetheenvironmentalpresenceoffluorochemicals and toassessthe potentialofany effectsusingecotoxicologictaelstresults.
The Biospheremonitoringprogram was designedinconsultatiownith Dr.John Geisy of Michigan StateUniversityT.his plan isbeing viewed asan iterativperocessto assessglobal distributioonffluorochemicalsA.s resultsareobtainedfrom theglobalenvironment,the plan istoconcentrateon thoseareaswhere fluorochemicalsare detectedinsamples and focuson additionalsampling and analysesinthosespecif'lioccations.
Initiallsya,mples oftissuesand blood plasma arebeingcollectefdrom archivedspecimens coveringdifferenstpeciesand locationsA.reas offocusincludeNorth America (Great Lakes and coastalmarine locations)t,he arcticregion,and Europe.Speciestobe studied includelaketrout,walleye,salmon,catrisha,nd brown trout;cormorants,eaglesand albatrossm;usselsand shellrtshm;arine mammals; and otherspeciesT.hissampling plan is inprogressand as data isobtainedand reportsgenerated,additionalsubmissionswillbe made toEPA.
Included inthissectionare the followingdocuments:
1. LCMSMS AnalysisofExtractsreportedin:"PreliminaryReport Analysis ofPerfluorinatedCompounds inEnvironmentalSamples" by P.Jones and K. Kannan - 4/7/99
2. FinalLaboratory3M Reportson AnalysisofFluorochemicalsinWild Bird Livers- 4/28/99
3. ScreeningofPFOS levelsinEagle and Albatross- 5/8/98