Document 5De2Ljad9aQdq48e0EyEZJOwD

3M Katherine E. Reed, Ph.D. Staff Vice President 3M Environmental, Health and Safety Operations 900 Bush Avenue, Building 42-2E-26 PO Box 33331 St. Paul, MN 55133-3331 651 778 4331 ^_ Certified Mail ov ,* ' - - T O ''\r fo il 3 P "7 / f / June 14, 2005 05JUH2 :25 Jtiq~oo-'iYZ3 7 Document Processing Center EPA East - Room 6428 Attn: Section 8(e) Office o f Pollution Prevention and Toxics US EPA 1200 Pennsylvania Avenue NW Washington DC 20460-0001 NoCBI CONTAIN NO CBI RE: TSCA 8(e) ADDITIONAL INFORMATION SUBMISSION: Docket No. 8EHQ-1200-14837 Dear Sirs: In December o f 2000, 3M submitted a draft report o f a mortality study o f 3M em ployees at a perfluorooctanesulfonyl fluoride (POSF)-based fluorochemical manufacturing facility under the above-referenced docket number. The final report o f that study was submitted in September o f 2001. In April o f 2005 w e submitted a final report on a follow-up incidence study that was conducted to investigate the findings from the prior study. W e are now submitting a poster that was presented at the 44thannual meeting o f the S o ciety ^ o f T oxicology in March o f 2005. The poster, Urinary Bladder Endpoints in Workers and Rdisl Exposed to Perfluoroocatanesulfonvlfluoride (POSF) and Related Compounds, presents dat&_ from the incidence study mentioned above and a rat inhalation study1 looking at urinary p~ bladder endpoints. The data from these two studies indicate that the excess risk o f bladder 1 cancer initially reported was not associated with exposure to POSF-related substances. Please contact John B utenhoff at 651-733-1962 should you have any questions or i f w e can t o provide additional information. Sincerely, -iKv "1 Katherine E. Reed Staff V ice President Environmental, Health and Safety Operations Enclosure 89050000447 1The submission regarding the rat study was submitted to EPA on July 1, 2004 as supplemental to 8EHQ-1180-373. The final report on that study has not been submitted. Urinary Bladder Endpoints in Workers and Rats Exposed to Perfluorooctanesulfonyl Fluoride (POSE) G. Olsen1, B. Alexander2, S. Cohen3, and J. Butenhoff1 *3M Company, St. Paul, MN; JUniv. of Minnesota, Minneapolis, MN; 3Univ. of Nebraska Medical Center, Omaha, NE Abstract_____________________________________________ Worker utA potential Mgb expoeur loP&SF-nJalul cunpoundr, Sidedlog perfluoroeclaiMritUuciife I f f OS), had 3 Madder caacer death! a 4 t!p n -lri (SUB U J ; l i % Cl 2.4- 37.4). Thru* compound have not Aom geooluxkky, and toiicokigy Bodies Ondudlag cancer biosuayt) uiA PEGS and related retfuaamidar hive not A on Madder affect, but repesl- tx poairedau * w t sot mlaiUbte for POST. To further Abdy Aeaiaoctttioaof tapomr to Madder cancer, w InVMtigafed pntonllal Madder effectof POST in raU and Maddar caacer iocldeftca in worker!. Epidemiology. h u t a a of iubtgh rurtburdiip, bring members (N * IfiK) of lb study were contacted by mail toaaewer a guriAmaalr* about bAddm canter, and 74% participated. Validation occurred by m edial record w daalb certificate Kir Ao*e original sueiabertdertsMd luridencari bladder caBear was compared ioaxparttd baud an NCI SEES data. Bacalls 11 Madder c u ra re were idantiflad Ik e Standardise! Incriusc* Balia (SIB) tor Ae entire csdsort eswl.3(M % C 1 0 .5 -3.1). Tba SIB* for aver Marking and working far m oo A sa oas year to a bigb axpUtodJob Kan 1.7 (95% C liU - J.gj ami 1.1 <i. U 0 .2 - 3 J ) , respectively. Bet were aspoaedby inluA to uPOST*brtriay, Sdaya)w>*h for la n d d week*tp B 300pp m and 13 weeks(ti, 10,100, B 100 ppm). Complete urinalysis m dona on overoigbt utinea. S E h W tay Amant analyw tor cryoaidcakuii and immediate pH ear amductad on fresh morning urine. Sagittal fccuonsri urinary bladder vara token tor SEM aaalyji* and atamneni of cab proliferation by prefeferaliug call nuclear antigen (1 cactiwu, | 0*ceBs/eeciion). BtuilK Thera weft no traistraaiUretoiad findings trilh ratpact to unnatyns parameter, tacAdlog pH and solids, nor cheagw of AeorMbritutB, including no eXfuriure-ralatod increaae In call pndtferaUon. T ba ttudiaa do not mppori th* hypoAaris ibat tba tr e e s HA r i Hadder ctnmr butiahy rcpurlad a t due to tspuaurt to POST-niaod auleriab 4 PFOS. Introduction & Objective________________________________ Methods (3)_______________________________________ Tbit epidemiology tody uns approval by the Uniaardty of Mim awta InaitotW ai Re*tir Board. Tba Imtdenceofbiaddar cancar to tb tody poputaUnn mttoreparU to tbaaapected Inddaoca based on rata derived trent Ac Survadlaaca Epidemiology and Bad Basuita(SBBB) at Ae National Cancar iniluta.* Tba age, gandar. alendar-yaar, and qmsura yrrtflc pwaan-lima of A cohort o a t tabulated using Aa Life Tabla Anaiydc System tor A paramal computar developed by Ae NKiSH.' EtUmtlesof biadder anew HA by retoUvv ttu u b ttto eapotun u d iy Aa udy populelion a sa s Internal referent ara asada udng M a a a and togislk ragroaioa. The aaaiyns abo accounted tor Aa Umr4apandan natura dAa PM S qmmra, ai psrtkipaju* accrued PfOS expemra M dtfTaram leveltover tba course of empksycnejU. Results Table 3 Inhalation Study: Results P"--- "<. OrcraO sa sa -- rr------- ---------- U>) eddend w t n U . 4J, IM 4, sud 2M * 141 ppm h r ndernei Aus,A au** amceetrittea mieaed ere dea to leagai wuceulradnae ribb, 1UU,and Iddppto l 'neekde. SEH eadX-Bs aaledariUrte udBleddee I t o , es* r>a PmtBeraAto to fc. OreAUto Notreettoem-reiaud differmu (rem u e u d t- o ^ t e e i t o i c r a a c e p f e Oms uetod far A* kiducyer urtuery bieddar eure antri. Ne oeaootolrelated buemaUdaeriAeureAellal dme wert Aaarvtd, eed bandea dsutficslieu BeAu4dgy` ter mbdt d u p s el the reiertoery bladbar toeu, A Maddar ttouea arid be dewifiri as 1 aal, tadiattogaerimi tiwte.Nakeeraul ucisary trildt -- earHiei AaraaaAgaieOmaaaisri^re^eri uriuery stUmsut Tb<pera a l r i edle Metnleg fer P O * (cab prellbraUaa todeu) to tkc sate aid (Bai luMkdfel ttnua eur et loaeared et Ablae epemr ceuceotretien. 3bb ppm,Aet I ead d eebaupeeutt (Tibie dp TsbAd Perceot Furiliva Ceils (Mean SD. % CebcStoifblg (erFCNA) Exposure Duratimi POSF Etputore IW tA 4 Week* (cam bVcaluma) M 1 MF 2.0 t 2.0 0.5 .J 4 0 a 1. 4.1*10 300 U >23 fti 04 4.4 a 14 4.1 * B.7 Introduction: Tb 1U fedUly in D n a u r, AAfaema tan*sawof two major {Midweek* (Barat parfluotrae-taieHuHmiyi Qmgride {fO SS, C j f ^ d jF i bated pedaiiy cbamicaU Tbeaamreidlty chemicals bava a wide tanga ofapplicatil i , iadadint surface ucalmettu, papar and packaging pttdatt t nii , and performance rbamirel * POSE band ehamimucun degrade or be ntnabniiiad to pertbiortiociananttfnnata (PFOS, C ^ t,SOt'). A cuhmi mortality riudy of entrant and farmer aoploycct of iba 3M Decatur facility trat conduci to avalala iba health of worker--y- --* tu POSF bacd fluorocbentkaU1 The cohort indudtd 2011 workers who sera aployad far a a d u h sa n o fl year aubaDctnturfacUBy. Thetuodatdked morality nU ofShlX )tot bladder cancer tor Iba Mira s o r t(ore* a u 4 J &S% CU I 0-14.11, and Ut SUB fer employri* atto bald high postre Job* a a r 114 (45% C l* li-)J.4 ). However, ih**t refutas n a n baaed on only tbraa cast*. A resita of Iba current and peri uue of known e r rejected Madder carcinogen ai ibi* (ability could not Utibuto rpuMta to a known bkaddtr carcbttigaa. Dna to the larga d&erMca batwuu toHdenca and caorulity rata tor bladder cancar, a n o ru llti body irti not fuMyaseartain Iba bardan of bladder cancar in a ptpulathn Objectiva; Tba goal of Uw budlw repealed bereta war to dciarnina whetbar Iba oteervtd in the mortality eudy a tr rpriaaniniet dibe entire bladder cancer experience of the spinyeesat iba 1M Dacatof fedUty. TU ataccureptitbad ibrosgk a cata findlag attori utiag direct Miad wbb tba population, io ddifion. Maddar and ttrlnalyae endpoints pManHaby tetoxd to iba etkdogy of Madder caarer ware m lualed in raU ctpuud to POST 1^ tabalalion. Of A 2 W original oeaibertof Ae coborl, I t f n r e dstaraUaad lo ha dacmtad at Aa Ana tba gueathmnairt tras n i and 1,400(74%) rty m d e d to tba guamiwtnaira. Tba ranaaitdng d i did bm rayond aiAar baran Aay dacbrtad to particpala or mara aot reackable. Blaven Maddar cncer tamarera Idantifiad. Fieard AeeafMirare ManlifUdee AedeeA castlflcalesoad * oere reportad bb Aaguadkinnatre Tba dAgnodrof tba mlf reponed Madder eanrerr trara cBnfirosed for tu casas, bul feur teif.reportad caerr declinad to siga Aa coman! ton* pemiuiag aiidatiafs. T*t Aa Maddar tancar c u u a m ram ea and itt ara mu SO yaar* of age a l Aa lima of diagnods or daaA. (Tabte 1) T W a* ue citar aeanciation hotucan ampbymeat A PFOS esposad )obs and Maddar cancm (TaMa 2). Similar ram iu trara observad for iba Une-dpendan aspomra am lydf (Tabkt ly An addUiaoM 2 caasof bieddar cancar M uid b t upected in Aa noB-ratpoodicla basad mi Ae SBEJtdaia. The potenliaby tuiind caeosin Aa DatoaapnndaUowiid aMy a ged Aa tteuiU KAa rata Albenon-rugiosidafiis aasblghi Iban AspramiUflg ratos la AepopulaUon. A sandiHity analytU Aonud Aak A oriar to raar* noratoa) attoUcal gidficam* at iba p < JH and p < 41 tovals, Ae a to efMadder cancar Muid need tobe 2. and 14 Untasgraator ibas tba mtoof Aa rMarae poputatton, rupectiveiy. Tbecetoce A< OMitrbHtliee to A erlA eimala from Aa nanreqtondanu ould be marginal unieto Aere ta ca ubaaottaily klgbcr biaddtr cancar ratos Ib Ae nao rvtpondenl group Aaa raiarent uunukUmt TM Subam r nd MttoboiiA Anrivi Analyst! of terina und urina ssntplw rrvmied tb pttmnc*r i PFO&and FFOA, bui ned PSP, suggesting hydrotyOc conferaua at POST to PFOS wtd uptake r i residuai PFA in A* sample Strum and urinary carneanIralions of PFOS were proportional to duet A ecpouri rets (Figura! 1 and 2, roipoclAdy.i. PFOA u p rem a t A ntaA sarua atconcantratian uptoapprorim autr 20 ug/mL liter 13 ks A A t JOS opui dom gtoup. fa additimi, tea$ r i PFOA and P R wat* AisrMd in control rate, pocably from davinanmental andim food morca* Methods (1)__________________________________________ Study Poaulatino Tba IkltiHilSyln Oacalur, Alabama isdivided A lira major ptonic. The Awuical pleoi preduca* peoalty chemical, including Ae POSFUoe of chamicalt. T beoA eruA tfU ni|dam >barea vuriet) of fiimr are preducad, but iiUle or no occupuikeal fluorachoukai t^oeurasoccur. Tba p--j,,uiu-x. .j Mi currant, radrad.and form- Peculur employed aba oara ei^AU for Ae original cohort mortality audy. AOa m e n t emptoyeec ubo w t aei part of A original cutout, Mu<* bind after January 1, IMS, > ir i also tnduded A A t case finding acmira, hut wd a primary focus of A* anaftda us Ibeir esponra bad ocrurrad ao remmtj AM Bs nreilfftruAm to Maddir cuacar U unUbuly. Address krfurmatirm m updated Armagh * variety <d Iraeiag raeourm* outmtawdlabie to Aa UnfearsBy of M b n o u , inctodify T B W ^U a, L eru a Data, and btalionaJ O taageof Add, if a cohort m m ber ns found to b a n Med Acs Ac newlulity toudy Mscomptoiadu copy of IbadaaA mnifiegu ogsobtaAed b u u Aaixalauf tecofd. Bearuitmewof afipremmad bring cohort member as Aaiiaud nub s latter und brochure AM ouiiAad Aa taMtuts fer the fludy, Aa mopa af the dndy, bat Is reguirad uf participant, gad awaranca*of cwtfidamieiiiy. Tba study guestiunneire foitoued Aa recrubnasm letter by approztmaieiy one tm k . Tba primary putpom of tba <tuesUnnaire n s identb) cau of Madder cabcis and ttii jenr~fgtiginirir Tbi qui n l n n ik i ntn n r -n f ill tiiitrry rf -T -k fx : a baevn ctsk factor toe Madder cancar. Nutonspuodtott* erere cseiacud by mad as4 triapbaoe. Peitiripantr reportoig a Madder cancer diagnod ere cun(actad by letter, friA totephune fuUuer- up, to request perrautoon to cuauci Acir pbydclao to verify tba diagnod. Table 1 Methods (2) Discussion & Conclusion Dm spew iieiM iiaitdieaed Ae praitauly deu-ribad an itn4 A Aa atertaliiymidy.*Aspad af dtb upMUCtneoaa.el. acutoWO* aeKeatntom e u o n t n gaeuKtric atea m ai ff>OSterete (71% coaMeuce Aurvallfer Aemtotl fiaat nuptnyaee it ItJ4 ppmlugtoL) (1% Clrii.7-l.U)eadfer At jtceol Anpieal ecupteyeetb.14 ppa (1% C3^6.1t a i(|. Tbe aepeuir u>Am piasi aa^ieyatais d ie n ti to bt Adututed by euweaiatald nginiure treoiyceaaity te the Aentiral plato. Per Aemicai pieut jubi iba bi^Mrigeetodric ateealexi eftom a N W ratoo-md A o d sperile (to pfeelfriluued by tlu ueU peretx (1Appm), d i f l u eperitere(t3 ppuij, eu4 oiMtoeiece e i f t i n j l J pptoi. SupurieiairBHMgarvtk.bppakabisptostonid.fppaigtiigAMrdtb uerktg-4 ppm) ad dtolimradm istoiat tu ppa) bed tueur gaetoeulctu ia acutoPFOCtenta. WIA Ac katm itip *f Aa augurjeh-^actfic aanuuPPUS laude,u eerb u d p it )eb sud dapsitaeut ubtoldea bysataodar Urnepeded A A t uveb hfatoryreeiude were eelegeriaad Atoemef Ae Idtowtog Area toil axpemreat 1. Ne 4irt u mukftac* eepuarre cePOgP-bated dii>r'irtimdrrle(emtop iAb pittogebri Leupsttodal woAflacc upserrt lePOV-baaad duorsAaucaia(AdudcuiA Jobear - |i * -- iguairty aoairid tarbakAou uriraaaieai>1,beai* ad afaty estkcn, adBAltorsUn sadataslsaud aaMgusk . U y t pateutld euckplvesupemire to POSP-baead AaeaeabetoitAa(Adudcs a d penles* (btaulcet uparatoro ssieteuaucs erben, aaiHoperatore, stoteptratorrsedereompervieen). Theee Aree ceugedea A be referred Uer toe een-repfiod,je rrpriie and high apwaia Au adddeual i---------1..----j..... ---ii|nig Al n -t inpiitod 1---- ry-rirr `` tilgh icy~lin Jirbi rd i"-T POkF baatdJab agpemr du r i 1,1 aud 16regredii*!; ban! e s biatoeattoriag data. Tbc yaantpeto A tsA JA weraawlttpUidby At retaUn eetgtncu dentop a mauaialiae yuenUuliraaapetun Beide. BEST COPY AVAILABLE