Document aJR8RR8KNv6yJbEn7NOJp8Z0a

tomo we R606 . 6St.12P7au3l,1M0N.55144-1000 FYL-0500-1378 00AoFEE... . prea 8 3M AIMIRAAA FYI-08-801378 May 25, 2000 MEF Betll Dr./ACEhXaPrRlEeSsSAuerMALL Q85A0N00H0R0A00R1N4TI ` DiCrheecmtiocral Control Division Office Of Pollution Prevention And Toxics U4n0i1teMd States Street, Environmental Southwest Protection Agency Room 403 East Tower (Mail Code 7405) Washington, D. C. 20460 Re: ISnufpoprlmeamteinotnaOlnInPfeorrfmlautoiroonocOtnanPoeircfAlcuoirdoAonctdane Sulfonates And Related Compounds : o = C5 g 7 S2 3 on & SR 2 25 2 Dear Charlie: Pursuant perfluorooctanoic acid. to our recent We also are ceonmclmousniincgatiinofnorsm,at3iMonisonenpcelrofsiiunogroioncftoarmnaetion on spurlefvoinouastleys uanndderreclaotveedrcoofmopuoruApnrdisl 2w1h,ic2h00s0u,pMplaeyme4,nt2s00in0foarnmdatMiaonys1u8b,m2it0t0e0dlteottyeorsu We are providing this information on a voluntary basis as part of our continuing discussions with EPA regarding fluorochemistry. The enclosed information on perflucrooctanoic acid includes the following: => eCnovpiireosnmofenptoaslt-s1c9i7e5ncsetuadrieeass:an(di) cpehrytsaiicnalotahnedr icnhfeomrimcaatliopnrorpelearttiinegs;to(it)he following environmental fate and transport, (iii) environmental monitoring; and (iv) ecotoxicity. For each study, 3M has prepared a summary in the HPV "robust summary" format. = Copies of post-1975 studies and certain other information relating to the following h(ieva)lpthhaerfmfaeccotksianreetaisc:s;(i()va)ctuetreattoolxoigcyit;y;an(idi) (gvein)omteodxiicciatly;su(iriiv)erilelpaenacteead-nddose toxicity; epidemiology. 3M has included a detailed index of this information subdivided by 0C001 Charles Auer May 25, 2000 Page 2 eaancdhepciodmepmoiuonldo.gyWsteudailessoahnadvehaevneclionsceldudseudmcmoapriieessoffocrertthaeinmepduibclailshseudrvsetiuldliaensce in this area in order to provide appropriate context. = Lists of all studies in progress and planned studies, along with study protocols or study plans, where available. = Abibliography of pre-1976 studies subdivided by each compound. = tAhbaitbwlieogarraepphryovoifdaicnugtceotpoixeicsitoyf skteuydiaecsutseubsdtiuvdiideesd(wbiythearcefhecreonmcpeotuondth,eeHxPceVpt guidance). = Abibliography of published studies in 3M's possession. 3M is continuing its file review and will supplement the enclosed information on perfluorooctanoic acid as appropriate. As you review this information, we ask that you bear several points in mind: = The enclosed information in information spans several boxes. each box with labeledfilefolders We have organized the and indices to aid EPA's review. Tinofoernmsautrioen,thwateyaolusoanardeyaotutracshtaifnfgatroetahbislelettotearctcheesisndtihceesmocsotvepreirntginsetnutdies and other information. = 3maMdperobvyid3eMd ttohethAegeTnScCyAwiStehctaiolinsto8(fea)lldofclkueortoucnhedmeircaclo-vreerlaotfeodusruMbamiyss4,io2n0s00 letter. This list included all submissions on perfluorooctanoic acid. = oTnheaqeuncelooussedanidnlfoorrmsaotlivoenntinscolluudtieosnssotufditehissomnatpeerirafll.uorMoaocntyanoofitchaecisdtuadsiewselrlefaesr to the test substance only by a 3M product identification number with a "T", L", `"wFhMe"reorav"aFiCl"abplree,fiixt.isAolfttheonungoht apnoaslsyisbilseotfotdheetetersmtisnuebfsrtoamnctehehsatsudbyeernepiorntcliutdseeldf, tuhseedid3enMt'istyhoifsttohreictaelstprsoudbuscttanncuem.beTroraescsoirsdtsintoinptreorvpirdeteincgomtphoessittuidoinesi,nfwoermhaatvioen (set.ugd.,y cnoammpoesiotnitohnepienrdceexntaangde/so;r soonlvtehnetsctoundtyenstu;mpmuarriyty.grPaldeea,seetcn.o)tneexthtattoseoamceh formulations contain a small amount of "perflucrochemical inerts" -- a term which creofmeprosnteonatsc.ompFilneatlelly,y iftlsuhooriunladtebdecraercboognniczheadinthwaitthprnoodufcuntcftoiromnualliazteidons have evolved over the years, and thus, someof the test substances do not constitute current products. eCCoR Co BB Charles Auer May 25, 2000 Page 3 = 3M understands that the Agency has requested information on perfluorooctanoic acid from duPont. For this reason, we are not providing copies of studies on perfluorooctanoic acid in 3M's files sponsored or conducted by duPont. = Consistent with the information previously provided on perfluorooctane sulfonates and related compounds, 3M has not provided all analytical chemistry reports on perfluorooctanic acid. Rather, we have enclosed analytical chemistry reports which may prove useful to EPA in interpreting certain studies; understanding the details of analytical chemistry methods; or verifying human and biomonitoring data. = The enclosed information does not include a "Use And Exposure Information Profile" or "UEIP" for perfluorooctanoic acid. Our present intention is to provide you with completed a UEIP form for perfiuorooctanoic acid by June 9, 2000, = The information on perfluorooctane sulfonates under cover of our May 4, 2000 etter included documents relating to ongoing mechanistic research by Dr. Ken Wallace of the University of Minnesota. Please note that this research also encompasses perfluorooctanoic acid. The comparative metabolism research by Dr. Marion Anders of the University of Rochester Medical Center also includes perfluorooctanoic acid; there are not documents yet available relating to this research. COCo3 Charles Auer May 25, 2000 Page 4 3M looks forward to discussing the enclosed information with you and other EPA staff. In the meantime, please do not hesitate to contact me with any questions. Very truly yours Ht OO AH glpprirs William A. Weppner, Ph.D Directorof Environmental, Health, And Regulatory Affairs Specialty Materials Markets 3m Bldg 236-1B-10 3M Center St. Paul, MN 55144 (651) 733-6374 (phone) (651) 733-1958 (fax) E-mail: waweppner@mmm.com Safety Enclosures eeco4 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Acute Toxicity 1) Inhalation Toxicity Studyof T-2305 CoC - Rat 4) Final Report, An Acute Inhalation Toxicity Studyof T-2305 CoC in the Rat, Bio/dynamics, Inc., Study No. 78-7184, May 3, 1979 b) Technical Report Summary, Analysis of rat serum of FC-143, reported in termsoforganic and inorganic fluorine, Central Research Laboratories, June 20,1979 2) FDienvaellRoeppmoernt,t ACcourptoerOatriaolnT,oxSitcuidtyyN(oL.Ds1o3)7-S0t9u1d,y3inMRRatesf,erIenntceemaNtoi.onFalluRoersaedarcFhC-a1n4d3, Lot 340, Mays, 1978 3) Final Report, Acute Oral Toxicity Study of T-6669 in Rats, Coming Hazelton, Inc., Study No. CHW 61001760, 3M Ref. FC-143, January 10, 1997 4) Final Report, Primary Skin Irritation Study - Rabbits, Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 5) Final Report, Primary Eye Iritation Study - Rabbits (Washout Procedure), Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 6) Final Report, Primary Eye Irritation Study - Rabbits (Not Washed), Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 7) Final Report, Primary Skin Imitation Test with T-3371 in Albino Rabbits, Riker Laboratories, Study No. 0883EB0079, 3M Reference FC-26, Lot 389, July 13, 1983 8) Final Report, Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Reference No. T-1585, FC-26 (perfluorooctanoic acid), September 16, 1976 9) Final Report, Primary Eye Irritation Study - Rabbits, Biosearch, Inc., 3M Reference No. T-1585, FC-26 (perfluorooctanoic acid), September 16, 1976 10) Final Report, Acute Dermal Toxicity Studyof T-6342 in Rabbits, Coming Hazelton, Inc., Study No. HWI 50800374, 3M Ref. No. FC-1090, L13364, Lot 1, F11426, sodium perfluorooctanoate solution, October 24, 1995 1 CO00S Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Acute Studies- Bibliography Only 1) Final Report, Acute Oral Toxicity - Rats, Biosearch, Inc., 3M Reference No. T-1395, FC-143, March 4, 1976 2) Final Report, Primary Skin Irritation Stud-y Rabbits, Biosearch, Inc., 3M Reference No. T-1585, FC-26 (perfluorooctanoic acid), September 16, 1976 3) Final Report, Acute Oral Toxicity Study in Rats, Hazelton Laboratories America, Inc., 3M Reference No. T-3974, Lot 390 (FC-126, approximately 88% solid), February 6, 1987 4) Final Report, Primary Dermal Irritation Study in Rabbits - Method, Summary, Raw Data Appendix, Hazelton Laboratories America, Inc., 3M Reference No. T-3974, Lot 390 (FC-126, approximately 88% solid), December 31, 1986 5) Final Report, Primary Eye Irritation Study in Rabbits - Method, Summary, Raw Data Appendix, Hazelton Laboratories America, Inc., 3M Reference No. T-3974, Lot 390 (FC-126, approximately 88% solid), January 14, 1987 6) Final Report, Primary Eye Iritation/Corrosion Studyof T-6564 in Rabbits, Coming Hazelton, Inc., Study No. CHW 60504574, 3M Ref. No. FC-1015, Fluorad fluorochemical emulsifier, L13167, straight-chain APFO solution, September 5, 1996 7) Final Report, Primary Dermal Irritation/Corrosion Studyof T-6564 in Rabbits, Coming Hazelton, Inc., Study No. CHW 60504573, 3M Ref. No. FC-1015, Fluorad& fluorochemical emulsifier, L13167, straight-chain APFO solution, August 15, 1996 8) Final Report, Acute Oral Toxicity StudyofT-6564 in Rats, Coming Hazelton, Inc., Study No. CHW 60504572, 3M Ref. No. FC-1015, Fluorad fluorochemical emulsifier, L13167, straight-chain APFO solution, November 8, 1996 9) Final Report, Acute Oral Toxicity Study ofT-6342 in Rats, Hazelton Wisconsin, Inc. Study No. HWI 50800373, 3M Ref. No. FC-1090, L13364, Lot 1, F11426, sodium perfluorooctanoate solution, November 16, 1995 10) Final Report, Primary Eye Iitation/Corrosion StudyofT-6342 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 50800376, 3M Ref. No. FC-1090, L13364, Lot I, F11426, sodium perfluorooctanoate solution, October 12, 1995 11) Final Report, Primary Dermal Iritation/Corrosion StudyofT-6342 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 50800375, 3M Ref. No. FC-1090, L13364, Lot 1, F11426, sodium perfluorooctanoate solution, September 28, 1995 CC0006 2 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Genotoxicity 1) An Assay of Cell Transformation and Cytotoxicity in the C3H 10T 1/2 Clonal Cell Line for the Test Chemical T-2942 CoC, Environmental Pathology Laboratory, Stone Research Laboratories, University of Minnesota, 3M Ref. No. FC-143 Lot 340, L138679, March 5, 1981 2) Final Report, Mutagenic Evaluation of T-2015 CoC in the Ames Salmonella/Microsome Plate Test, Litton Bionetics, Inc., Study No. 20838, 3M Ref. No. FC-143, February 1978 3) Final Report, Mutagenicity Test on T-6564 in an In Vivo Mouse Micronucleus Assay, Coming Hazelton, Inc., Study No. 17750-0-455, 3M Ref. No. FC-1015, L13167, straight-chain APFO, November 1, 1996 4) Final Report, Mutagenicity Test on T-6564 Measuring Chromosomal Aberrations in CHahrivneesstes,HaCmosmtienrgOHvaazreylt(oCnHIOn)c.,CeSltlsu:dywiNtoh. a1C7o7n5f0i-r0m-a4t3o7rCyOA,s3saMyRweift.hNMou.ltFiCp-l1e015, LI3167, straight-chain APFO, September 16, 1996 5) Final Report, Mutagenicity Test with T-6564 in the Salmonella - Escherichia Coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay, Coming Hazelton Inc. Study No. 17750-0-409R, 3M Ref. No. FC-1015, L13167, straight-chain APFO, September 13, 1996 6) Final Report, Mutagenicity Test on T-6342 Measuring Chromosome Aberrations in Human Whole Blood Lymphocytes with a Confirmatory Assay with Multiple Harvests, Coming Hazelton, Inc., Study No. 17073-0-449C0, 3M Ref. No. FC-1090, L13364, F11426, Lot 1, sodium perfluorooctanoate, November 1, 1996 7) Final Report, Mutagenicity Test on T-6342 Measuring Chromosomal Aberrations in Chinese Hamster Ovary (CHO) Cells: with a Confirmatory Assay with Multiple: Harvests, Coming Hazelton, Inc., Study No. 17073-0-437CO, 3M Ref. No. FC-1090, L13364, F11426, Lot 1, sodium perfluorooctanoate, September 16, 1996 8) Final Report, Mutagenicity Test on T-6342 in an /n Vivo Mouse Micronucleus Assay, Coming Hazelton, Inc., Study No. 17073-0-455, 3M Ref. No. FC-1090, L13364, F11426, Lot 1, sodium perfluorooctanoate, December 14, 1995 9) Final Report, Mutagenicity Test with T-6342 in the Salmonella - Escherichia Coli/Mammalian-Microsome Reverse Mutation Assay, Coming Hazelton, Inc., Study No. 1703073-0-409, 3M Ref. No. FC-1090, L13364, F11426, Lot 1, sodium perfluorooctanoate, December 14, 1995 3 CeCo7? Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Repeated-Dose Toxicity 1) FFilnuaolroRcehpoermti,caVlolFuC-m1e4s31i-n4,RTatwso, RYiekaerrOLraablor(aDtioerti)esT, Ionc.,xS/tiuCdayrccNion.iog0e2tni8c1iyCtRy0S0t1u2d,y of conducted during April 1981 - May 1983, August 29, 1987, with Study Report Amendment No. 1, dated November 2, 1987 2) Ninety Day Subacute Rat Toxicity Study on Fluorad Fluorochemical FC-143 a) FFilnuaolroRcehpeormti,caNlinFeCt-y14D3a,yISntuebrancauttioenRalatReTsoxeiacricthyaSntdudDyevoenlFolpumoernatdCorporation, Study No. 137-089, 3M Reference No. T-3141, November 6, 1978 b) 930M-dIanytesrunbalacCuotrersetsupdoyn,dfernocmeJroenFCBe-l1i4sl3eatnoalJyEsiLsoonfgs,edrautmedsMaamrplcehs2f0,ro1m97ra8ts of ) 3M Intemal Correspondence re FC-143 analysisoffiver samples from rats of 90- day subacute study, from Jon Belisle to JE Long, dated March 31, 1978 3) BFiinoa-lTeRsetpoLratb,or2a8t-orDiaeys,OrInac.l, TSotxuicdiytyNoS.tu8d5y3w2i-t1h06F5C5-,1343MiRneAflebriennoceMiNoc.e,TI-n1d7us4t2rCiaolC, Lot 269, Undated [1977) 4) Final Report, 28-Day Oral Toxicity Study with FC-143 in Albino Rats, Industrial Bio-Test Laboratories, Inc., Study No. 8532-10654, 3M Reference No. T-1742CoC, 01 269, September 29,1977 5) Final Report, Repeat Application 28 Day Percutaneous Absorption Study with T2618CoC in Albino Rabbits, Safety Evaluation Laboratory, Riker Laboratories, Inc., Study No. 09790AB0485, 3M Ref. No. FC-143, March 15, 1981 6) Ninety Day Subacute Rhesus Monkey Toxicity Study 4) Final Report, Ninety Day Subacute Rhesus Monkey Toxicity Study, Intemational Research and Development Corporation, Study No. 137-090, November 10, 1978 b) Analytical data, FC-143 Analysis of IRDC 137-090 Samples [monkey serum and liver samples], 3M Central Research Laboratories, May 16, 1978 7) PFienraflluRoerpooorctt,anVooalt.eI(IC,A1S3N-oW.ee3k82D5i-e2t6a-r1y)TionxiMcailtey SRattusd,yHwaiztehltTo-n51W8i0s,coAnmsmino,nIincu.,m Study No. HWI 6329-10Ma0y, 17, 1993 % 8) CFionmalinRgepHoratz,elStoDna,ilInyc.D,oSsteuOdryaNloT.oxCiHciWty6S3t2u9d-y19w7i,thApTr-i6l63609,(1F9C9-7143) in Rats, 90G608 4 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Ongoing 26-Weck Capsule Toxicity Study with Ammonium Perfluorooctanoate (APFO) in Cynomolgus Monkeys, Covance Laboratories Inc., No. 6329-231, 3M Ref. No. T-6889.3. In progress. Protocol provided. Note: The study is sponsored by the Associationof Plastic ManufacturersofEurope, APFO Toxicology Working Group. 3M has submitted a notice under TSCA Section 8() regarding preliminary data from this study. 3M and other Working Group members have received draft reports on the 4-week range-finding study and the full study, but these drafts are now obsolete. Final reports are in preparation and will be provided to the docket when available. In addition, the Working Group is sill awaiting the hormonal `measurements report covering cholecystokinin data; serum, urine, feces and liver APFO levels; palmitoyl CoA oxidase determinations; cell proliferation evaluations; and bile acid and receptor level determinations. 00009 5 Attachments to Letter to C. Auer dated May 25, 2000 `Toxicology Studies and Other Information on PFOA Pharmacokinetic Studies 1) Final Report, Analytical Study, Single-Dose Intravenous Pharmacokinetic Study of Tte-t6r0a6b7uitnylRaabmbmiotnsi,u3mMsalRtefi.n wNao.terL1a3n4d9i2so(p4r5op%ylpearlfclouhoorlo)o,cSttaunodiycNao.cidAMDT120694.1, November 28, 1995; report includes Final Report, Single-Dose Intravenous Pharmacokinetic Studyof T-6067 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 6329-151, February 1, 1995 2) Final Report, Analytical Study, Single-Dose Absorption/Toxicity StoufTd-60y67 T6068, and T-6069 in Rabbits, 3M Environmental Technology & Services, Study No. AMDT-011095.1, November 28, 1995; report includes Final Report, Single-Dose. Absorption Toxicity Studyof T-6067, T-6068, and T-6069 in Rabbits, Hazelton Wisconsin, Inc., Study No. HWI 6329-152, May 26, 1995; T-6067 is L13492, 45% perfluorooctanoate tetrabutyl ammonium salt in water and isopropyl alcohol; T6068 is fabric treated with high level of L13492, 45% perfluorooctanoate tetrabutyl ammonium salt in water and isopropyl alcohol; T6069 is fabric treated with low level of L13492, 45% perfluorooctanoate tetrabutyl ammonium salt in water and isopropyl alcohol 3) ADME studies with FC-143-1C a) Final Report, Absorption of FC-143-"*C in Rats After a Single Oral Dose, Riker Laboratories, Inc., January 14, 1950 b) CFihneamlicReaplosrtD,ivSiysnitohnesainsdaRnidkeCrhaLraabcotreartiozraiteiso,nIoncf.,FCJ-a1n4u3a-r'y*2C3,,C1o9m8m0ercial ) Final Report, Extent and Routeof Excretion and Tissue Distribution of Total Carbon-14 in Male and Female Rats After a Single IV Dose of FC-143-C, Riker Laboratories, Inc., February 7, 1980 d) Final Report, Extent and Route of ExcretionofTotal Carbon-14 in Pregnant Rats Aftera Single Oral DoseofAmmonium 'C-Perfluorooctanoate, Riker Laboratories,Inc., July 1, 1983 ) CFhinoallesRteyporratm,inEenhTraenactemdenEtl,imRiinkaetrioLnaboofraFtCo-r9i5es-,"*ICnca.,ndMaFrCc-h14133-,"1*9C8i0n Rats with 4) Final Report, Single-Dose Intravenous Pharmacokinetic Studyof T-6564 in Rabbits, Coming Hazelton Inc., Study No. CHW 6329-186, April 18, 1997 5) Final Report, 5-Daily Dose Dermal Absorption/Toxicity Study of T-6364 in Rabbits, Coming Hazelton, Inc., Study No. CHW 6329-185, April 28, 1997 ` 00019 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Teratology 1) Teratology Studyof T-2998CoC in Rats 4) Oral Rangefinder Study ofT-2998CoC in Pregnant Rats, Riker Laboratories, Inc., Study No. 0680RR001S, February 25, 1981 b) Final Report, Oral Teratology Studyof T-2998 CoC in Rats, Riker Laboratories, Inc., Study No. 0681TRO1 10, December 15, 1981, with Amendmentto Final Report, December 22, 1981 and Protocol 2) Teratology Studyof T-3141CoC in Rabbits 4) Oral Rangefinder Study of T-3141 CoC in Pregnant Rabbits, Riker Laboratories, Inc., Study No. 068 IRBO331, November 18, 1981 b) Final Report, Oral Teratology Study of T-3141CoC in Rabbits, Riker Laboratories, Inc., Study No. 0681TB398, February 23, 1982 ) 3M Intemal Correspondence re analytical analysesofT-3141CoC, fiom LD `Winter to DR Ricker, dated February 5, 1982 3) Letter re further testing from E. Marshall Johnson, Jefferson Medical College to Dr. Franklin D. Griffith, dated November 19, 1982 4) 3M Memo re FC 95 and 143 Teratology, from Marv Case to Georjean Adams, dated May 26, 1998, enclosianng analysisofthe eye lens defect C0021 7 Attachments to Letter to C. Auer dated May 25, 2000 `Toxicology Studies and Other Information on PFOA. Human Sera/Medical Surveillance Epidemiology 1) F. A. Ubel, et al. Health Statusof Plant Workers Exposed to Fluorochemicals- A Preliminary Report, 41 Am. Ind. Hyg. Assoc. J. 584-589 (August 1980), with Summary. 2) Leonard M. Schuman & Jack S. Mandel, An Epidemiologic Mortality Study of Employees at the Chemolite Plant (February 1980), with Summaryofstudy. 3) Jack S. Mandel & Leonard M. Schuman, "Mortality Study at the 3M Chemolite Plant" (January 1989), with Summaryofstudy. 4) Frank D. Gilliland & Jack S. Mandel, Mortality Among Employees ofa Perfluorooctanoic Acid Production Plant, 35 JOM 950-954 (September 1993), with Summaryof study. 5) Frank Davis Gilliland, Fluorocarbons and Human Health: Studies in an Occupational Cohort (October 1992)(unpublished Ph.D. thesis, University of Minnesota), with Summary. 6) Geary W. Olsen, etal., An Epidemiological Investigationof Reproductive Hormones in Men with Occupational Exposure to Perfluorooctanoic Acid, 40 JOEM 614-619 (July 1, 1998), with Summaryof study. 7) Frank D. Gilliland & Jack S. Mandel, Serum Perfluorooctanoic Acid and Hepatic Enzymes, Lipoproteins, and Cholesterol: A Studyof Occupationally Exposed Men, 29 American JournalofIndustrial Medicine 560-568 (1996), with Summary of study. 8) Geary W. Olsen, et al. An Epidemiologic InvestigationofPlasma Cholecystokinin and Hepatic Function in Perfluorooctanoic Acid Production Workers, 3M Final Report EPI-0003, (1997), with Summary of study, Protocol, and Manuscript accepted for publication in 2000, Drug & Chemical Toxicology. 9) Physician Plant Summary Reports Regarding Medical Surveillance Program at Cottage Grove (1978-1991) 4) Summaryof Program Reports b) Blood Levels of RF/F in Selected Employees, dated June 20, 1978 ) 3M Internal Correspondence re 1981 Chemical Division Health Evaluations from DE Roach to PF Riehle, dated February 16, 1982 d) 3M Intemal Correspondence re 1981 Chemolite Health Evaluations, from DE. Roach to PF Richle, dated August 12, 1982 8 90012 Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA ) 3M Intemal Correspondence re Inorganic Fluoride Determinations, from DE Roach to PF Riehle, dated April 9, 1984 ) 3M Intemal Correspondence re Organic Fluorine Levels, from DE Roach to PF Richle, dated August 31, 1984 ) 3M Intemal Correspondence re Medical Examinations, from L Zobel to DW Dworak, dated March 20, 1987 h) 3M Intemal Correspondence re Chemolite Evaluations, Fall, 1990, from Larry R Zobel to Clair Murphy, et al., dated May 10, 1991 Previously submitted with April 21, 2000 leter to Charlie Auer, Fluorochemical Exposure (Serum) Assessment of (3M) Decatur Chemical and Film Plant Employees. Ongoing Studies See list of planned studies submitted with letter of April 21,2000, which will address perfluorooctanoic acid as well as perfluorooctane sulfonate 00013 9 Attachments to Letter to C. Auer Dated May 25, 2000 Published Literature in 3M's Possession Abdellatif, A.G., V. Prat, H.S. Taper, and M. Roberfroid. The modulation of rat liver carcinogenesis by perfluorooctanoic acid, a peroxisome proliferator. Toxicology & Applied Pharmacology 111 (1991) 530-537. Abdellatif, AG. V. Prat, J. Vamecq, R. Nilsson, and M. Roberfroid Peroxisome proliferation and modulation of rat liver carcinogenesis by 2,3dichlorophenoxyacetic acid, 24,5-trichlorophenoxyacetic acid, perfluorooctanoic acid and nafenopin. Carcinogenesis 11 (1990) 1899-1902. Belisle, J., and D. Hagen. A method for determination of perfluorooctanoc acid in blood and other biological samples. Analytical Biochemistry 101 (1980) 369376. Biegel, LB, ME. Hunt, and JC. Cook. Effects of ammonium spteurdfilesu.oroTohcetaTnooxaitceol(oCg8i)sto1n3[L1e]y(d1i9g93c)el3l99f.unction: In vivo, ex vivo, and in vitro Biegel, LB. RCM. Liu, ME. Hurt, and J.C. Cook. Effects of ammonium perfluorooctanoate on Leydig cell function: In vivo, ex vivo, and in vitro studies. Toxicology & Applied Pharmacology 134 (1995) 18-25. Borjes, HK. and R.G. Thurman. Peroxisomal proliferators inhibit Acyl CoA synthesis and stimulate protein kinase C in vivo. Toxicology & Applied Pharmacology 126 (1994) 233-239. Clapperton, RM., BT. Ingram, RH. Ottewill, and AR. Rennie. NMR spectroscopic and neutron scattering studies on ammonium decanoate-ammonium perfluorooctanoate mixtures. In: Mixed Surfactant Systems. ACS Symposium Series 501, Eds.: PM. Holland and D.N. Rubingh, American Chemical Society: Washington, DC, 1992, 268-277. Clegg, E.D., J.C. Cook, R.E. Chapin, P. Foster, and G.P. Daston. Leydig cell hyperplasia and adenoma formation: Mechanisms and relevance to. humans (abstract). Reproductive Toxicology 11(1) (1997) 107-121. Cook, J.C, SM. Murray, S.R- Frame, and M.E. Hurtt. Induction of Leydig cell adenomas by ammonium _perfluorooctanoate: A possible endocrine related mechanism. Toxicology & Applied Pharmacology 113 (1991) 209-217. coc14 Cook, J.C., ME. Hurtt, SR. Frame,L.B. Biegel. Effects of Wyeth-14,643 (WY) and ammonium perfluorooctanoate (C8) in Cr:CD BR (CD) rats. The Toxicologist 13(1] (1993) 399. Cook, J.C., ME. Hurtt, SR. Frame, LB. Biegel. Mechanisms ofextrahepatic tumor induction by peroxisome proliferators in Crl:CD BR (CD) rats. The Toxicologist 14111 (1994) 301. Feller, DR. and U. Intrasuksri. Mechanism of peroxisome proliferation by perfluorinated fatty acids in primary cultures of rat hepatocytes (abstract). Toxicologist 13 (1993) 395. Gilliland, F.D. Fluorocarbons and human health: Studies in an occupational cohort. Unpublished Ph.D. Dissertation, University of Minnesota, 1992. Gilliland, F.D. and 1S. Mandel. Mortality among employees of a perfluorooctanoic acid production plant. JOM 35[9] (September 1993) 950-954. Gilliland, F.D. and J.S. Mandel. Serum perfluorooctanoic acid and hepatic enzymes, lipoproteins, and cholesterol: a studyofoccupationally exposed men. American Journalof Industrial Medicine 29 (1996) 560-568. Griffith, F.D., and JE. 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Critical Reviews in Toxicology 28[1] (1998) 1-33. 00022 -9- PFOA and Associated Salts Syronmms:sP2P6,aoa0F,per,FF-o147F0E5 7R A. ar" | conpons [Water, acetone and toluene solubility estimate-s FC-143 Lama| 11/17/81_|copyofdata sheet Environmental Fate and Transport STF GBT [ oroaA-- ySEsT F-- EFrnEe moe po all a TTi omd so[encraamsaanenemany Pramswearyoe I |MTET EB|T m e a (MSy U) s| rs tr reat = i S [oneersa EEERR TI ESE rT EE |(Comell) Cr SF | We vecre|copiesof data rs ose: Rp cts botanic20800100 wens| ones En Pace Analytical, |generated final report, copies of f[E mnameent:ee as report, copy of 00023 TET PFOA and Associated Salts { irir, Ecotoxicity Elements A UT es re [sedF woe Ee E, |96-hour acute static toxicity to bluegill sunfish - FC-143 3M Env. Lab opcf sa sheet |copyofdata sheet |Two reports : "The EffectsofContinuous Aqueous: [Exposure to 78.03 on Hatchability of Eggs and Growth and survival of Fry of Fathead Minnow (Pimephales Examinationsof Fathead Minnow (Pimigphales promelas) Exposed to 78.03 for 30 Days". |Technical Report Summar-y Aquatic Toxicity Testing: F EG&G Bionomics,| and Sept. Wareham, MA 1978 ---- |copiesoftwo final reports. [Robust summary, ry |seme| sn ps recs |Chronic Toxicity of Fluorochemicals to Daphnia magna (Water Flea) - FC-143, and statistical analysisofdata providedby AScl Corp., Duluth, MN 3M Env. Lab [Robust summary, 8/31/1984, |summary report, -| 8/10/98 _ letter report 00024 1 noc ams PFOA and Associated Salts t{ 5 RU -- wena roRevoveamteero ron et 128 meio| aor [Rponoeaos sore sctesto copia mag e120| seman| sons oo varisas arn ottur aot attoety host mow. 128 Roeeoeotom c4t stgrsiato anton (02 2001. emia | oso s o[oeeostoo ne mResoarosnae |teMitcrcsotAoxhcteesatT- FoX-y1pa0ont0sf3 105 ohFas erow, | Ea3morMEpcnieva.rLeneab:s| En 3/7/90 3150 Rf[moshomreeeaatrsnns,ama:: Eco catoauctAscnea RToyrof 1To0r8icoTteosowsicn,noapair||nmtToopsmRaems, trerna, [-- in reser a.Soneeprom ceesrToyoirttes ovFactor, | [aLRnavonorsroe,| anes| 124s |mapon _2400_o[ atapo-- n cunesToyorton vs tics |aarnsonaesr|e, 3756 ossstnsumma, Rosse, heroessc 145 emis | ass [|Recoeoevopfeideratssa : hires st rc 118 vescopoifdeatsa hoorsre 018 ves [Robust summary, copoifedasta 00025 i { . i PFOA and Associated Salts i Ecotoriclty Elements | [ ec Ee pe De ate Robust summary, ctvatedSludgeRespration inionTest FC-1015:X_|_aMEnv.Lab | _4rzsioe c[sohpeieetss of data Acute Toxity of FC-1015 tothe Fathead Minnow, | LabTorRatoWriibesu,ryInc, Robust summary, Fimephales promeias MaTrRbenWiebst.iyMA| 5/15/96 {nalreport GnreoFwrtehshawnadteRerpArogd,uctSieolneTnoasiicuymTceasptriwictohmFuCtu-m1015 and | LMaaborrbaethoeriseds., MInAc, Rnoabursetposrutmmary, = LabTorRatoWriibest,ryInc, Robust summary, cute Toxity ofFC-to1the0Da1phi5nd, Daphniamagna| Marehead. WA nat report rr rr rr r r E[SoSmme Repos I 1 ich isl T [ReportoFc 1m 43 y Fo Corrs | w sMEnv.tab |r 32079_ecty vica report | i | 1 i 00026 |i i i Attachments to Letter to C. Auer dated May 25, 2000 Toxicology Studies and Other Information on PFOA Update to Submission of May 18" 13. PFOS Perfluorooctane Sulfonate 1) Letter from E. Marshall Johnson to William C. McCormick, Il re Hazleton teratology studies, dated December 7, 1983. 2) Letter from E. Marshall Johnson to William C. MeCormick, II re Riker teratology studies on PFOS and ethyl FOSE, dated November 12, 1982. 8. N-E(FOSE alcohol | N-ethyl perfluorooctane sulfonamidoethanol 1). Letter from E. Marshall Johnson to William C. McCormick, Il re Riker teratology studies on PFOS and ethyl FOSE, dated November 12, 1982. 2) Final Report, Biological Phase, Metabolism of N-Ethyl Perfluorooctane Sulfanomido SEitnhgalneolCa(pNsetu-lFeoDsoe;seT,-6C3o1v6a)ncIen,CSytnuodmyoNlog.us63M2o9-n2k2e6y,sJFuonlel9o,wi1n9g99Administration ofa Note: Analytical work associated with this study is ongoing. cQooz? 10 PFOS didecyldimethylammonium salt e -- ---- lm we Wore-------------- 1 1 T 1 o a cL eT rTntenn rE ee a reSSEE =voenn oma [foa=nn=i [AcuteToxicity of P3025Developmental Material to |AScl Corporation,| hoor|[Robustsummary, og [Growth Inhibition of P3025 Green Alga (Selenastrum |ASel Corporation,| oer|[Robust summary. inhibitory Effectosf P3025 on Activated Sludge |ser |r seman.| 00028