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ARa2e -1229 12pf Frenne . APFN Work Group ~ - Presentation to EPA January 16, 2003 IAS } "COMPANY SANITIZED. DOES NOT CONTAIN TSCA CBI" Agenda Background What is the APFN Work Group? Relationship with FMG What is APFN and what is it used for? Analytical Methods Development Toxicology and Environmental Program Current Knowledge of APFN Ongoing toxicology/ecotoxicology program Summary 2 Fluoropolymer Manufacturers Group (FMG The mission of the FMG is to promote the continued safe manufacture and use of fluoropolymers made using fluoropolymer polymerization aids (FPA) while establishing and supporting responsible use of fluoropolymer products and minimizing the impact on the environment 3 What is the APFN Work Group? Separate SPI Work Group Formed to evaluate APFN as compared to APFO Members are producers and users of APFN Limited number of participants complicates the sharing of some information 4 APEN Work Group Members Asahi Glass Co. Ltd. Atofina Chemicals, Inc. Solvay Solexis, Inc. (Ausimont) < What is APFN? APFN is one of the FPAs used by the FMG member companies to produce fluoro- polymers as reported in the FMG mass balance update in Sept. 2002 FPA -- Fluoropolymer polymerization aide commercially available perfluoroalkyl carboxylate surfactant 6 Commercially Available APFN CAS number 72968-3-88 7 Use of Commercial APFN PVDF Applications Handled only in industrial processes Highly weatherable architectural coatings Ultrapure water systems in semiconductor and pharmaceutical industries + Handling of corrosive chemicals -- pipes, filter media, tanks, etc. + Fire resistant electrical insulation Lithium ion batteries No direct consumer applications q Fluoropolymer Manufacturing Group Point Source Emissions Include APFN Voluntary worldwide commitment to contain Global minimum emissions reduction of 50% + Base year "99 or '00 Goal years 2004 - 2006 Emissions reduction forecast completed + 49% Reduction by 2004 67% Reduction by 2006 10 Analytical Methods Development Method development and validation underway at CRO Selected laboratory experienced with this family of chemistry Provide quantitation at ppb - ppt levels Three matrices: Water (LC/MS/MS) | -Serum (LC/MS/MS) -Air (LC/MS) i" Analytical Methods Development Methods developed Validation in progress Timing of validation Water: completed November 2002 to coincide with toxicology testing Serum: completed December 2002 + Air: January 2003 | I APFN Toxicology Data Acute Animal toxicity data in literature < LC50 4 hr. inhalation --rat: 820 mg/m3 < ALDoral --rat: 187 mg/kg Repeated dose oral toxicity -- mouse Dietary exposure -- 14 days Increased liver weight -- + males > 1 ppm; females > 3 ppm Lethality > 300 ppm females; > 3000 ppm males Commercial APFN LD50 oral -- mouse: 500 -- 2000 mg/kg (15% aq. soln Ames Test - Negative 13 CpuormimfeierdciAaPlFOand LD50540 mg/kg sm ww [atoCraatirorn,|hrocsroosmsm0agmeanrer. Target organs Sermons a vesLiver, pancreas, (oecr aon. 2000 CpuormimfeierdciAaPlFNand | ALD 187 mg/kg ALD 96 mg/kg (mouse)(15% aq soln) | Riessmmamsgmenaer' ] T| rotm| an] Liver (limited data) Ya eYesre Liver, testes, Ma essotaei Tr proliferator [[ os orogfiee i" APEN Testing Strategy Determine differences and similarities of commercial APFN and APFO Use screening approach to begin 3 Proposed studies Chemical/physical properties Health effects + Environmental effects | i$ | APFN Studies Planned Physical/chemical properties Vapor pressure Water solubility Stability in water (hydrolysis as a function of pH) Health effects + Acute oral toxicity in rats + 28 day oral study with reproduction screen (rats) Environmental effects Acute studies in fish, daphnia, algae 16 APEN Testing Status Water method completed Nov. 2002 28 day oral study started at TNO in 4th Quarter 2002 Doses selected are 0.1, 0.5, and 2 mg/kg Anticipate results 2nd quarter 2003 + Preliminary range finding results were reported to TSCA 8(e) office Dec 20, 2002 Environmental effects and phys/chem properties testing initiated 1 Summary APFN not widely used Limited mostly to PVDF manufacturing Primarily industrial applications; No direct consumer applications Significant reduction in potential exposure sources planned + Emissions at fluoropolymer plants Toxicity and environmental effects work progressing on schedule 8