Document QkYYgwOyJVJoxbxY7KKD5J4qk

L30p ARRA6 -- [297 OFTNCIC Tomer Resch Progam Mest Fru 3.100 WIAR2Y PY 2:45 [wwe [onowvewnov [weemoves | ewanaoomes | z I ae orion Tremor| wos | rr] gad r r r T ] r r T r ] r rr r ] Er E r EO A ] r r r r ] r r r r ] r rt r ] o -- EE ------------------ TRP Telomer Research Program 9 = Clariant 3 February 2003 kes Presentation to U.S. EPA - sos OPPT -. ... DAKIN 3g yV : : 3 TRP Presentation Outline : Introduction Information Sharing * Product & Article Analysis Telomer Manufacturing In-Use Mass Balance * Issues for Discussion * Metabolism & Degradation * Closure & Path Forward - + | eo Expectations e Alignment o Path Forward EE---------- | Information Sharing e TRP has a database for collecting and sharing scientific information eo Types of Information we have = Member Company Information = TRP Study Reports = Public Literature = Relevant Unpublished Reports (non TRP) e We are prepared to provide this information to you. We want to understand what you would like to have and would like to develop a process and mechanism. Who is contact point? I | A Information : Submissions to Date e TRP Presentations: 2000-2002 = TRP organization & structure = Work Plans, Timelines = Study Protocol Overview = 8-2 Telomer B Alcohol Selection Criteria = Updates of 15 Studies and Results Shared e Study Reports (8-2 TBA): January 2003 = Acute Oral Toxicity | = In-vivo Rat micronucleus Assay = Reverse Mutation Assay 7 NarrI) _ Information : Study Report Timeline RCCENT February 2003 Acute Aquatic Studies : Fish, Daphnia, Algae Respiration Inhibition + Hydrolytic Stability ] METI BCF Study Univ. of Toronto Progress Report:TRP funded research March 2003 + Physical - Chemical Properties + Atmospheric Indirect Photolysis + 90-Day Subchronic Oral Toxicity + Terrestrial Effects : Earthworm, Nematode, Plants May/June 2003 + OECD 301 Ready Biodegradation with transformation products and mass balance I 2 Workplan Commitments and Discussion January 10, 2003 TRP Letter + Proposed Workstreams for 2003 Ey A 7 Tr Product & Article Analysis Tier I- Product & Article Analysis Direct Analysis : Workstream A (4 - 6 months post approval) + Products : polymeric | + Articles : carpet, textile, paper - need EPA protocol review & approval - who & how Aging : Workstream B method & protocol development with EPA + timing dependent upon methods & protocols I to Product & Article Analysis : Direct Analysis : Workstream A + Develop and demonstrate sampling and analysis methods for Products & Articles Isotopically enriched (M+2) PFOA standard C4F,5'CF,'*COOH will be used to help ensure quantitation accuracy Treated Products & Articles (12-15 Items) - Products | + are the principal products sold by TRP members worldwide + all are polymeric: the fluorotelomer group is linked to a polymer backbone + Article Types : Carpet, Textile, Paper + Specific sample information will be company confidential I " Product & Article Analysis Tier Il - Potential for Human Exposure via Articles | conditional - dependent upon Tie|r results, review and discussion with EPA 12 Err Telomer Manufacturing and End Uses Processes : Intermediates to Finished Products Potential PFOA Releases & Occupational Exposure Industry Mass Balance and Production Data Major Consumer Uses ae eu [op Telomer2Man=ufacturing Process : A CHE AU luor ) "Building Blocks" TeFlomFeArFodd F(CF,CF),CH,CH,! Telomer B lodide F(CF,CF,),CH=CH, Telomer B Olefin * Actual Process Be cproamcptiacneyvaries by + Do not use or add PFOA in the process + Generally, these processes are closed and PFOA creation minimus &/or emissions are expected to be de- FICFLloOmFe)rBCHOAlcHohOolH G" all Products * aMacntuifvaecstuorcicnugring within the U.S. will be arate FGF L0F),CHLCH,0GOCH-CH, onerial; b`ycionmdmiuvniidcuaatled to EPA es `companies under I -- I Telomer Manufacturing Process Process = TRP member companies will meet with you individually to describe their U.S. Telomer manufacturing processes and exposure / release information = Initial discussions within one month | o Need EPA contact to set meeting date/time Telomer Mass Balance : In-Use | e Develop a Telomer industry view of the product trails for Textiles, Carpet and Paper and a mass balance for each = Generic process for article treatment = Identify potential release points = Develop Predicted Environmental Concentrations from this work = 4-6 months post agreement on work plan = mass balance computation e Environmental Releases = 8-2 alcohol atmospheric degradation pathway(s); report in 2 | months | I Telomer Production Data - Draft o Global Telomer A equivalents produced in 2000-2002 = approximately 5- 6.5 Million kg/yr * Regional Product Distribution : North America - 40% Europe -30% Asia Pacific -30% eo Polymers : 80% of total product manufacture Preliminary Data Analysis 85% of 8-Fluorinated Carbon based products are polymeric oo : 17 Issues for Discussion Feedback and Alignment : 8-2 Telomer B Alcohol Workstreams - 2003 | Pharmacokinetics | Further mammalian toxicology tests (i.e.multi-gen) | Environmental Fate Studies Environmental Effects Studies Screening Studies Blood data - Biodegradation me yn Metabolism & Degradation | 8-2 Telomer B Alcohol-'"C Metabolism = pharmacokinetics studies (18 months) = interim reports when sections are completed Degradation = ready biodegradation study = further studies to follow = welcome protocol review and dialog on environmental relevance Feedback and Alignment I 7 | TRP Approaches to Study Biodegradation a CEUER BLETCA TEFT L * Modified OECD 301D Closed Bottle Test - a Mass Balance Investigation with Radiolabled Substance C,F,;'`CF,CH,CH,0H = Test design + inoculum from domestic sewage sludge + no headspace to avoid volatilisation losses sorption to test system is taken into account ion selective electrode to monitor the formation of fluoride putative metabolites such as F(CF,),CH,COOH, F(CF,),CF=CFCOOH, F(CF,),COOH will be quantified Analytical methods will meet FDA & EPA data accuracy andprecision guidelines = Results from preliminary investigations with cold material loss of parent compound was monitored by GC-MS no fluoride was detected up to LOQ of 1 ug/L after 28d of test duration results show no PFOA I 20 TRP Approaches to Study Biodegradation | Lab InvestigaotnRieoandsy Biodegradation e Modified OECD 301D Closed Bottle Test - a Mass Balance Investigation with Radiolabled Substance (cont.) = Timing with Radiolabeled study material + Investigation will start at the beginning of March 2003 + Duration about 6-8 weeks = Results + Results should be available at the beginning of May 2003 Draft report should be available in June 2003 2/ ; Metabolism & Degradation Telomer-Containing Polymeric Products = Develop a framework and test strategy to evaluate abiotic and biotic transformation of telomercontaining polymers = Discussion and Alignment for Path Forward = Available Immediately For Discussion Ty 22 Closure & Path Forward . Program and workstreams agreements between EPA and TRP Mechanism and timing for resolution Identification of spokespersons and contact points for EPA and TRP + Meeting Open Items -Resolution path forward Next Steps and Meeting