Document YLdgdkkwaQ7vx5ER5y1Bv90E

3ff ARL26 1094 MR 54 376 The Society of the Plastics Industry, Inc. Suite 600K 1801K Street, N.W. `Washington, D.C. 20006 AlExleecnutCi.vWe eDiirdecmtoarn Friday, AprilApri26,2002 CMsh.emMiacarlyCDoonmtrionliDkivision (7405M) RUoSoEmnv4i4r1o0nm-eMntal Protection Agency W1a2s0h1iCnogntsotni,tuDtiCon2A0v4e6n0ue, N.W. Subject: Fluoropolymer Manufacturers Group Presentation Slides Dear Ms. Dominiak: ZEEom 3 28 23 5 =5 > cOonpbieehsaolfftohfe tphreesFelnutaotrioopnoslgyimveernMtaonduafyacbtyurDearvsidGRruoruapk(aFnMdG)Geraalmd sKeenndniendgy,you the original and redacted Some CBI notes: a R226 = 21:. TtTohhiersecpllaeaptcyeerotifhsetnhCoeBtsICaBnrIie.tdiazcetdevdesrlsiidoesn.of the presentation i so marked and three blank sides were inserted 3 TmhaerkceadpyonoftthheeenpvreesleonptaetiaonndctohnetatiilneinpgagTeSoCfAthCeBpIreissecnotnattiaoinn.ed in the inter encvelope and s so EPhPaoAcpeeindtthohaitnsottihimhspeosirinttfaaotnretmatmotaitcotoennrt.iascstutihieeSnoctieftoryoyfouPrlanseteidcss Ianduhsitsryt.imeW,eIafrtehceroemamriettaendy otothweorrqkuiensgtiwonish, the Sincerely, vo : = 8Zz ox . == 3=7F /U breaeccoo | S-- 5 2at a 1 RECEIVED MR oe FMG Presentation to EPA April 26, 2002 oF Sanitized Copy i Three Blank Slides w/CBI Redacted > FMG A Special Purpose Committee of the SPI The mission of the FMG is to promote the continued safe manufacture & use of fluoropolymers made using fluorinated polymerization aids (FPA) while establishing & supporting responsible care in the use of fluoropolymer products & minimizing the impact on the environment. 3 Agenda Risk Assessment Approach APFO Environmental Distribution - Potential Exposure Routes Reductions in Environmental Releases - Industry Efforts Future Activity Wt Question? Are PFOA Serum Concentrations from Rat Toxicological Studies Useful in HumanHealth Risk Characterization? s Relevant Facts in the Rat Model Serum PFOA does not correlate to cumulative dose in rats Female rats rapidly absorb and excrete PFOA such that the concentration in serum is dependent on time of sample relative to the time of last dose. & Illustrative Clearance Curve c 2i g81 s s 3E . & Hours 7 Other Examples (Females) 100 % of an oral dose of "C-PFOA in pregnant rats was recovered in urine within two days. Female rats excreted essentially 100% of an i.v. dose of "C-PFOA after 24 hours. After single oral doses of 2.5 to 150 mg/kg PFOA to female rats, blood [PFOA] was 3 to 162 ppm at 30 minutes and 0.12 to 18 ppm at 24 hours. & Serum [PFOA] is not proportional to dose in male rats (and monkeys) after repeated oral doses. 7 Examples (Males) Mean male rat serum [PFOA] at the end of dosing for 106 days at 10 and 30 mg/kg/day were 50 and 45 ppm, respectively. Mean serum concentrations in male cynomolgus monkeys after six months of dosing at 3, 10 and 30/20 mg/kg/day were 77, 86 and 158 ppm, respectively. 10 Answer Serum [PFOA] in female (and male) rats after dosing is not a reliable indication of cumulative internal dose for use in human- health risk characterization. " Recommendation Use of standard EPA risk-characterization procedures, e.g., going from external dose in the animal model and application of appropriate uncertainty factors appears to be more appropriate for human-health risk characterization with PFOA. 12 Question? How is PFOA distributed to the US population? (Auer, 1/30/02) 3 Possible Sources of Exposure ManuFfPaActure Non-Fluoropolymer Products - Fluoropolymer Manufacture Dispersion Fluoropolymers. - Exposure i i i i i i i i i i PEON Impurities in POSF Related Materials Trans- formation 10 PFOA_| Telomer Based Materials [Sulfonate Based Materials Population Exposure ---- Material Flow -- " FPA Manufacturing Point Source Emissions New Capacity in US After 3M Phase Out + Significant Reduction in Capacity/Production * Significant Reduction in Emissions + Significant Reduction in Alternative Uses is U.S. APFO Manufacturing Summary Significant Reduction in Capacity 3M Production 227 tonnes (500,000 Ibs)/yr New US Capacity < 136 tonnes (300,000 Ibs)/yr + 40% Reduction in Capacity vs. Actual 3M Production Significant Reduction in Emissions + 3M Emissions < 21 tonnes (46,950 Ibs)/yr New US Capacity Emissions < 0.5 tonnes (1000 Ibs)/yr + 98% Reduction Significant Reduction in Alternative Uses * 3M non-Fluoropolymer industry global sales -- 6 tonnes (12,500 Ibs )/yr New US Capacity non-Fluoropolymer industry sales - Zero 1e Possible Sources of Exposure FPA Manufacture Non-Fluoropolymer Products Fluoropolymer Manufacture Dispe--r_--sion Fluoropolymers E . i Evxiproosnumreent i i i i| | } i |i! PFOA Impurities in POSF Related Materials Trans- formation 10 PFOA_| TeBlaosemder Materials [HShuilofsonnatte Point Source Emissions Population Exposure ~~ ------. Material Flow et 1 Non-Fluoropolymer Products 3M exiting production and marketing Dyneon will not market APFO Dupont and Daikin announced they will only sell APFO to "experienced and responsible users" in the Fluoropolymers industry. 6 tonnes (12,500 Lbs)/yr (3M global sales) ------> ZERO 8 Possible Sources of Exposure FPA Manufacture Nom-FPlruoodruoctpsolymel Fluoropolymer Manufacture Dispersion Fluoropolymers PPooipnutlaStoiuornceExEpmoissusrieons ----Material Flow = T i i i i i i i }i i General PEoxppuolastuiroen 9 Pron impuries in POSF Related Materials [etomer | Based | Materials Trans- formation PFOA_| [SBulafsoenadte Materials Blank Slide CBI Redacted Blank Slide CBI Redacted Possible Sources of Exposure FPA Manufacture Non Fuorapolymer Products Fluoropolymer Manufacture FiluDoirsoppeorsliyomners uoropolys } Exposure I i i i i 3 i i |i i i ry Impurities in POSF Related Materials Trans- formation 10 PFOA Tetomer Based Materials Sulfonate Based [Materials Point Source Emissions. MPaotpeurliaatlioFnloEwxposure ------_---- General Population Exposure 22 Dispersion Fluoropolymers Voluntary material balance request did not provide adequate information Will facilitate material balance + Developing communications package Developing testing protocol Goal to complete material balance by December 2002 23 Blank Slide CBI Redacted Possible Sources of Exposure RFA PA Non-Fluoropolymer Products Fluoropolymer | Manufacture Dispersion Fluoropolymers EnEvxiproosnumreent 1i } i i i i i i i i PFOA PIOmSpFu:riRteilesatiend Materials Trans- formation 10 PFOA Tetomer Based Materials Sulfonate Based Materials Point Source Emissions . PMoaptuelraitailoFnloEwxposure --= -- as PFOA Impurities in POSF Related Materials Some POSF related products had PFOA impurities at low levels Recent 3M study shows correlation between PFOS and PFOA levels in human blood 26 Possible Sources of Exposure FPA Manufacture Non-Fluoropalymer Products Fluoropolymer Manufacture Dispersion Fluoropolymers Pn T Impurities in i POSF Related } Materials } Tetomer | Based i Materials i Trans- i formation !| Moiee i 0 PEOA| [Sulfonate Material Flow -- Point Source Emissions. . Population Exposure ------ 21 Potential Transformation to PFOA Sulfonate based - 3M stops production + 3M study shows perfluorosulfonamide derivatives may be transformed abiotically to PFOA Telomer based - TRP plan previously communicated to EPA a8 Possible Sources of Exposure N S T Fa E= 98% Reduction, Ce) | Exposure Ei QRD) >50% Reduction Fluoropolymer | Manufacture J Dispersion} |Fuoropolymers | Tetome|r Based > oof Trans. 1f0orPmaFtOioAn RN a \ pmb Point Source Emissions ---- (EPopWulati)on | Sasnifcaunt Rerductieons [s[]7] 29 Question? How is PFOA distributed to the US population? (Auer, 1/30/02) 30 Future Activity Review and evaluate 3M U.S. population blood data + Sampling + Distribution of samples + Procedures for obtaining samples + Analytical procedures + Procedures specific for PFOA * Peer reviewed 31 Future Activity Assure appropriate sampling and appropriate and validated analytical procedures Continue to investigate the toxicology of APFO and the impact on the kinetic modeling Understand the potential for Telomer contribution ---->Evaluate the need to monitor blood 32 On-Going Activity Toxicity and Environmental Fate and Effect work to continue as planned Significant reduction in emissions and | distribution from the fluoropolymer manufacturing industry + FMG to provide forecast for emissions reduction FMG to provide periodic emissions summary Studies planned or scheduled for other potential contributors FMG will facilitate dispersion processors material balance TRP to communicate on Telomer issues 35 Summary Risk Assessment should continue via normal procedures No known adverse human health effects Significant reduction in potential exposure sources + emissions at fluoropolymer plants + emissions from new US FPA capacity + elimination of sales outside the fluoropolymer industry phase out of POSF related materials Toxicity and Environmental Fate and Effect work continues on schedule w