Document jg9qdRa97DNqoXqQ09eKwJyq9

pf AR 226 -- 114] Telomer Research Program (TRP) Update Presented to U.S. EPA - OPPT ~ 25 November 2002 ia Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 TRP Presentation Outline Introductions, Agenda, Timeline Review Telomer Production Mass Balance - Draft 8-2 Alcohol Studies : Toxicology, Environmental Fate & Effects PFOA Potential Consumer Exposure Route Industry Study Conclusions, Discussion & Questions Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 2 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomer Research Program (TRP) : 2002 Key Events - January 2002 : METI - April 18-19, 2002 : TRP Meeting, Wilmington - May 9, 2002 : U.K. DEFRA - June 13, 2002 : Environment & Health Canada - July 2002 : Joint FMG-TRP Meeting - Sept. 2002 : TRP Meeting, Tokyo - Oct. 2002 : TRP-EFE Work Team Meeting, Frankfurt - Nov. 2002 : U.S. EPA Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 3 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomer Production Mass Balance - Draft 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% Polymers : 80% of total product manufacture Preliminary Data Analysis % of Telomer Production Polymer Non-Polymer C4 C6 C8 C > 10 4% 16% 46% 33% 99% 45% 85% 88% 1% 55% 15% 12% Telomer A = F(CF2CF2)nI (n=2-8) Telomer Research Program (TRP) Asahi Glass, Clariant, Daikin, DuPont Company Sanitized Does not contain TSCA CBI 25 Nov. 2002 Total 100% 80% 20% 4 TRP8P-2reAslecnohtaotl iSotnudOieustline Rationale Radiolabel Study Material Update Toxicology & Descriptive Biology - Overall Plan & Timeline - 90 Day Subchronic Oral Study results - Developmental Study Plan - Pharmacokinetics Study Plans and Timeline - Reproduction Environmental Fate & Effects - P-C Properties (8-2 TBA) - Effects Studies - Fate Studies - Environmental Risk Assessment - EUSES Modeling - Broader Research Plan Overview Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 5 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI n-C8F17CH2CH2OH Selection Rationale Selection Rationale Included: Simple, Single, Pure, Representative, and Readily Characterized Most Common and Representative from Each of the 4 Major Producers - Includes Both Type and Chain Length Telomer 8-2 Alcohol Was Chosen To - Be Able to Characterize a Single Compound versus a Complex Product Mixture - Enable the Research Team to Study Metabolites in the Pharmacokinetics Work (ADME) - Study the Degradation Products and Locations in the Environmental Fate Studies - Enable the Team to Measure Critical Physical Property Data - Enable the Team to Radio-label a Single Key Compound for the Toxicology and Environmental Fate Studies Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 6 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Radiolabeled 8-2 Telomer B Alcohol F(CF 2) 1 7 4C F 2 -CH 2CH 2- O H Needed for Pharmacokinetics & Environmental Fate Studies Status Critical Marker Synthesis successfully demonstrated : Delivery December 2002 Confirming all is in place for safe handling & use F(CF2)814CH214CH2-OH Status Synthetic Route Demonstrated Synthesis complete Delivery pending specific packaging instructions For Adsorption-Desorption Studies Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 7 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomers Research Program Toxicology and Descriptive Biology Studies: Timeline* Telomer 8-2 Alcohol = F(CF2)8 CH2CH2OH 2001 2002 2003 Test Material 8-2 Alcohol TRP Work Work 1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q Acute Oral Range-Finding Oral Toxicity Subchronic 90 Day Gavage (Rat) w/ recovery Multigeneration Reproduction (Rat) Developmental Toxicity (Rat) Bacterial Reverse Mutation Bone Marrow Erythrocyte Micronucleus Test (Rat) Work Complete Work Underway Proposed Work * This is a proposed timeline and subject to change. Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 8 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Acute Oral Toxicity - Fixed Dose Method Dosing: 5 Male/5 Female rats, 2,000 mg/kg Results - No clinical signs - No mortality - Lethal dose >2,000 mg/kg Conclusion: - Does not present a significant acute toxic risk Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 9 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Genetic Toxicology Testing In vivo rat micronucleus assay - (Covance 22900-0-454 OECD, 1/25/02) Dosing: Single dose, male rats, 500, 1000, 2000 mg/kg Results - No clinical signs of toxicity - Not cytotoxic to bone marrow - No increase in micronucleated PCE's Conclusion: Negative results in test system Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 10 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Genetic Toxicology Testing Salmonella/E. coli Reverse Mutation Assay - (Covance 22900-0-409 OECD, 2/11/02) Strains: S. typhimurium, TA98, TA100, TA1535, TA1537, E. coli, WP2uvrA - With and without S9 activation Results - No toxicity to 5,000 g/plate - No increase in revertants Conclusion: Negative results in test system Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 11 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Oral Range-Finder Study : Summary Male rats at 125 mg/kg/day Test Day 81 - Decreased final body weight (86% of control) - Increased relative liver weight (149% of control) - Increased incidence of striated teeth (70%) Test Day 159 (Day 75 of recovery) - Increased relative kidney weight (114% of control) Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 12 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Range-Finder Study Summary Female rats at 125 mg/kg/day Test Day 81 - Increased incidence of striated teeth (70%) Test Day 159 (Day 75 of recovery) - Increased absolute kidney weight (123% of control) - Increased relative kidney weight (111% of control) - Increased relative liver weight (113% of control) Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 13 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Range-Finder Study Substances Identified in Blood Plasma - C8F17CH2CH2OH = Test Substance - C7F15COOH - C8F17COOH - C8F17CH2COOH - Note: These are the only species which were looked for. Total fluorine analysis shows that these do not account for all fluorinated species in plasma. Radiolabel pharmacokinetic studies are expected to identify and quantitate all species. Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 14 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol 90-Day Subchronic Study w/Recovery Study Overview Start : February 2002; In-life complete : 8/21/02 Control + 4 dose groups (1, 5, 25, 125 mg/kg/day) - Parameters: In-life (body weights, clinical signs, etc.), clinical pathology (hematology, clinical chemistry, urinalysis), neurotox (extended clinical observations, FOBs, and motor activity), hepatic -oxidation, and pathology (gross and histopathology), 90-day recovery - Kinetics subset - 5/sex/group Blood, liver & fat (day 175 only) Report Issue date - March 2003 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 15 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol 90-Day Subchronic Study w/Recovery Study Findings 125 mg/kg/day - Body weight gain decreased (M), liver & kidney weight increased (M&F) - Degeneration/disorganization of tooth enamel ameloblasts in male rats (not reversible) - Focal hepatic necrosis in males (not reversible) - Hepatocellular hypertrophy in males (reversible) - Renal tubular hypertrophy in males (reversible) - Chronic progressive nephropathy in females (not reversible) - Increased B-oxidation 25 mg/kg/day - Liver & kidney weight increased (M&F) - Focal hepatic necrosis in males (reversible) - Hepatic necrosis in males - No effects in females 5 mg/kg/day and 1 mg/kg/day - No adverse effects observed in males or females Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 16 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 90-Day Subchronic Study w/Recovery 8-2 Telomer B Alcohol vs. DuPont Telomer B Alcohol Product Observed in Both Studies Teeth effects At High Doses (>100mg/kg/day) - Increased hepatic oxidation - Increased liver weight - Increased kidney weight Increased plasma and urine fluoride Only Observed for 8-2 Telomer B Alcohol Increased incidence of focal liver necrosis at 25 and 125 mg/kg/day Increased incidence of chronic progressive nephropathy in 125 mg/kg/day females Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 17 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Developmental Toxicity Study DuPont Telomer B Alcohol Mixture Maternal findings - Decreased body weight at 500 mg/kg/day Fetal findings - Increased fetal variations at 500 mg/kg/day Maternal and Developmental NOEL = 200 mg/kg/day Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 18 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Developmental Toxicity Study Developmental Toxicity in Rodents (25/sex/dose; 4 groups) - Dosing: oral gavage (OPPTS 870.3800) Days 6-20 of gestation Proposed dose levels of 25, 125, and 250 mg/kg/day - Parameters In-life (body weights, clinical signs, etc.) Dams at euthanasia: visceral evaluation, uterine weight, CL counts, implantation sites Pups: sex, numbers, weight, visceral & skeletal evaluations, etc. Tentative start date - February 2003 Tentative issue date ~10 months from study start Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 19 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Radiolabeled 8-2 Telomer B Alcohol Pharmacokinetics Studies Radiolabeled Test Substance - [3-14C]8-2 Telomer B Alcohol : F(CF2)714CF2CH2CH2OH Exposure routes: oral and dermal - IV dosing for bioavailability Dose levels: 5 and 125 mg/kg - Match 90-day oral subchronic toxicity study Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 20 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Radiolabeled 8-2 Telomer B Alcohol Pharmacokinetics Studies Outline of Experiments - Analytical Methods & Material Handling (underway) - Pilot Studies (Start date February 2003) - Main Studies Absorption experiments (non-radiolabeled) Distribution experiments at plasma Tmax and Tmax/2 (radiolabeled) Elimination and metabolism experiments (radiolabeled) - Supplemental Experiments Biliary elimination experiments (radiolabeled), if >20% of dose is eliminated in feces following oral dosing In vitro metabolism experiments using rat microsomes and hepatocytes Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 21 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomer B Alcohol Kinetic Studies Timeline Radiolabeled Telomer 8-2 Alcohol = F(CF2)714CF2CH2CH2OH Method Development & Material Handling Issue Protocol Pilot Experiments Review Pilot Data with Sponsors Main Study : Absorption Main Study : Distribution Main Study : Excretion Supplemental Experiment, Bilary Elimination (if required) Supplemental Experiment, in-vitro metabolism (if required) DRAFT REPORT 2002 2003 2004 D JFMA MJ JA SONDJFMA MJJA SOND * metabolism included in main study line items Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 22 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Pharmacokinetic Studies Flowchart Mass Balance Studies ADME Studies In Vivo Evaluate Kinetic/Toxicity Literature Develop Preliminary Kinetic Model Refine Kinetic Model In Vitro Validate Kinetic Model Microsomal Metabolism Studies Hepatocyte Metabolism Studies Distribution Coefficient Determination Protein/Tissue Binding Properties Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 23 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomers Research Program Environmental Fate & Effects Work Plan Telomer 8-2 Alcohol = F(CF2)8 CH2CH2OH Tier I Water X Solubility X Sorption X UV/Vis Vapor X Volatility Pressure HLC, KOA X Hydrolysis Tier II Aerobic Biodeg. Act. Sludge 14C Aging / Sequester 14C Anaerobic Biodeg. Act. Sludge 14C Adsorption / Desorption 14C Indirect Photolysis in Air Radiolabel Study Material X Acute Ecotox Studies Fish, Daphnia Chronic Nematode Ecotox OECD 207 Acute Ecotox Earthworm OECD 208 Acute Ecotox Plant Seedling Tier III WaterSediment Biodeg. 14C OECD 303 WWTP Simulation Incineration Chronic Ecotox Daphnia X Bioconcen. Factor - Fish X Chronic Ecotox Algae Chronic Ecotox Fish Sediment Repro C. ripanus Sediment Repro L. variegatus BSAF X = Work Complete ; = Work Ongoing / Underway Fate Effects Physical Telomer Research Program (TRP) Company Sanitized Properties 24 25 Nov. 2002 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Physical - Chemical Properties n-C8F17CH2CH2OH UV / Visible Spectrum Vapor Pressure Sorption Water Solubility Henry's Law Constant (KH) - Complete - Complete - Still Learning - Complete - pursuing T dependent determination Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 25 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Physical-Chemical Properties Analytical Challenges The unique characteristics of the 8-2 Telomer B Alcohol (taken in total) make it challenging to work in complex environmental fate test systems. Taken separately, each aspect can be dealt with using simple controls. When all physical aspects are considered, it is difficult to design a system in which analytical measurements can be reliably performed. Considerations : - Solubility - Sorption - Volatility - Transformation and Mass Balance Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 26 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Acute Tests Results In Saturated Aqueous Solution Acute tests for fish, daphnia and algae carried out in saturated aqueous solution are complete Details on guidelines and test organisms - OECD 203, Danio rerio (30 fish according US EPA in test and control) - OECD 202, Daphnia magna Strauss - OECD 201, Scenedesmus subspicatus Ecotoxicity results in saturated aqueous solution Organism Fish Daphnia Algae Exposure 96h 48 h 72h Result type NOEC & LC0 NOEC NOECb & NOECr Result 0,18 mg/L 0,16 mg/L 0,20 mg/L No toxicity observed at the limit of water solubility Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 27 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Activated Sludge Respiration Inhibition Test An Activated Sludge, Respiration Inhibition Test according OECD 209 was carried out - with mostly municipal sewage sludge (minor industrial input) - at different concentrations, highest nominal concentration was 1000 mg/L - no respiration inhibition was observed at highest concentration Organism Exposure Result type Result Activated Sludge / Bacteria 3h NOEC 1000 mg/L No inhibition observed Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 28 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol 21 Day Daphnia Chronic Test 8-2 Telomer B Alcohol Test Substance Test type - flow through test at solubility limit approx. 150 ppb - 4 replicates with 5 animals Time schedule - working through test details, especially water concentration measurements - study to begin when details are worked out (est. 1Q2003) Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 29 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Earthworm, Nematode & Plant Studies Spiking of Sediment & Soil - dissolve 8-2 Telomer B Alcohol in a solvent (MTBE), mix with primary substrate (quartz sand); evaporation of MTBE in a ventilated hood; 24 Hr. equilibration Potential test substance loss due to evaporation was not observed; recovery was 96% when test substance was re-extracted Potential substance loss during the earthworm and plant tests (test period 14 & 21d) will be monitored by a total fluorine analysis at the highest concentration of 1000 mg/kg dw Range Finding tests were carried out to decide whether limit or dose response tests are necessary in the definitive tests Definitive Studies to begin Nov. 2002 with preliminary reports Jan. 2003 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 30 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol OECD 207 : Acute Earthworm Study Tested concentration in Pre-test - 10, 100 & 1000 mg/kd dw Pre-test Results - mortality at 10 & 100 mg/kg dw no mortality was observed at 1000 mg/kg dw some mortality was found - loss of body weight of surving worms was effects observed at 100 mg/kg dw. (statistically relevant) - pathological effects were observed at 100 and 1000 mg/kg dw Definitive test - 5 concentration dose response - from 10, 32, 100, 320, 1000 mg/kg dw. Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 31 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Acute Nematode Study 3d Reproduction Test - carried out according Hoess et al. Pre-Test concentration - 10, 100 & 1000 mg/kd dw Results of the Pre-test - body length & egg production no statistically relevant differences to the control group was observed Definitive test - Limit test at 1000 mg/kg dw Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 32 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol OECD 208 : Plant Seedling Emergence species : oat, rape & soybean Tested concentration in Pre-test - 10, 100 & 1000 mg/kd dw Pre-test Results - phytotoxicity no phytoxicity at 10, 100 & 1000 mg/kg dw. - rate of emergence not reduce at 10, 100 & 1000 mg/kg dw. - Inhibition of Biomass Growth no inhibiton for oat and soybean inhibition observed for rape Definitive Test - 5 concentration dose response - Oat & Sybean : from 10 mg/kg dw. to 1000 mg/kg dw. (geometric factor 10) - Rape : 6.25, 12.5, 25, 50, 100 mg/kg dw Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 33 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Bioconcentration Factor Conducted by METI, Japan on 98% Telomer 8-2 Alcohol Acute Study - Orange-red killifish (Oryzias Lapites) - 96Hr LC50 >125 mg/L Bioconcentration Study - Carp (Cyprinus Carpio) - 60 Days, Continuous Flow, GC/MS Analysis - Report being reviewed by TRP experts High Exposure conc. 10 g/L BCF 200 -1100 Low Exposure 1 g/L 87 - 310 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 34 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Aqueous Stability 8-2TBA, g L-1 water Hydrolytic reactions are one of 300 the most common means of non-biological degradation of substances in the environment. 200 150 g 8-2TBA L-1, sterile conditions Day 0 Day 5 pH 4, 7, 9 @ 50C pH 1.2 @ 37C 100 Sealed glass vials with Al-foil liners 4 replicates at 0 and 5 days - Extracted with MTBE - Analyzed with GC/MS 0 pH 1.2, 37C pH 4, 50C pH 7, 50C pH 9, 50C Telomer Research Program (TRP) Asahi Glass, Clariant, Daikin, DuPont Difference % -6.7 Company Sanitized Does not contain TSCA CBI 8.7 9.6 -3.8 25 Nov. 2002 mean + std dev.35 8-2 Telomer B Alcohol Aqueous Stability: Summary 8-2 Telomer B Alcohol is hydrolytically (abiotically) stable - <10% change in concentration after 5 days compared to day 0 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 36 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Adsorption-Desorption Study Objective: Provide data for determining the leaching and runoff potential of the test substance in soil and determine the Freundlich adsorption isotherm 8-2 TBA Methods: OECD 106: Adsorption - Desorption using a Batch Equilibrium Method; Developing analytical capability to extract and quantify test substance Non-GLP Start Date : Aug 02 End Date: Feb. 03 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 37 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI OECD 106: Adsorption/Desorption using a Batch Equilibrium Method Prerequisite Studies Set up of a suitable analytical method(s) Preliminary study: 2 or more soils Tier 1 Studies Selection of optimal solid/solution ratio Determination of equilibrium time Check for adsorption to vessel Equilibrium plateau achieved? YES Mass balance to check stability >90% Tier 2 Studies Adsorption kinetics to calculate Kd 5 soils, as appropriate Tier 3 Studies Telomer Research Program (TRP) Asahi Glass, Clariant, Daikin, DuPont Adsorption isotherms Company Sanitized Does not contain TSCA CBI Desorption kinetics Desorption 25 Nov. 200is2otherms 38 8-2 Telomer B Alcohol Soil/Water Partitioning Studies 200 "Cold" study material for method development Two materials - Keyport silt loam 150 Sand 17%, Silt 62%, Clay 21%, pH 5.3, OM 4.0% 8-2TBA, g/L - White Clay Creek sand Sand 98%, Silt 2%, pH 7.2, 100 OM 0.4% Mix for 15 m and 46 h, separate phases Extracted with hexane from 50 solid and water phases, SPE to clean, analyzed Low recoveries - need radiolabel study material Telomer Research Program (TRP) Asahi Glass, Clariant, Daikin, DuPont 0 Keyport WhiteClay Company Sanitized Does not contain TSCA CBI 25 Nov. 2002 Mean + Std dev 15 min 46 hours Control 39 8-2 Telomer B Alcohol Soil/Water Partitioning Studies: Summary At 15 min - Good recovery (>90% of expected) of 8-2 TBA from both soils Recovered primarily from solid phase, except for <4% in solution of White Clay - Poor recovery from control with no soil Recovered from both solution and tube At 46 hrs - Poor recovery from both soils White Clay <25% of expected Keyport <75% of expected - Improved recovery from control with no soil - 62% vs. 45% after 15 m Need to improve recovery to achieve mass balance Test procedure and analytical method development continues Radiolabeled test material C8F1714CH214CH2OH studies to begin Dec. 2002 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 40 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI 8-2 Telomer B Alcohol Biodegradation Studies 28 Day "Ready" Biodegradation Screening Study - Cold Test Material C8F17CH2CH2OH - Test Systems Non-acclimated municipal sludge Acclimated industrial sludge - No yeast for co-metabolism - Endpoints monitored : parent loss, fluoride Begin Dec. 2002 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 41 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomer Research Program Environmental Risk Assessment (ERA) EUSES Evaluation TRP is utilizing EUSES and the inputs required for this model to help shape and guide its environmental research plans and data generation for 8-2 Telomer B Alcohol Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 42 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI EU ERA Approach with EUSES Parameters used in EUSES which influence results most - tonnage produced and used - release fractions during production & use - number of use days - elimination & distribution in stp (biodegradation, volatilisation, sorption to sewage sludge) - partitioning coefficients for all compartments (water/air, water/sludge, water/suspended solids, water/soil, water/sediment) - half-lives in water, sediment & soil Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 43 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomer Research Program Environmental Fate & Effects : Broader Research Plan Develop a Telomer industry view of the product trails for Textiles, Carpet and Paper and a mass balance for each Gather existing physical-chemical property and toxicology data from the Telomer Producers on : - 6-2 and 10-2 telomer alcohols [F(CF2)nCH2CH2OH, n = 6, 10] - telomer olefins [F(CF2)nCH2=CH2, n = 6, 8, 10] to determine whether and where additional data may be needed Develop a framework and test strategy to evaluate abiotic and biotic transformation of telomer-containing polymers Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 44 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Telomers Research Program Environmental Fate & Effects Studies : Timeline* Telomer 8-2 Alcohol = F(CF2)8 CH2CH2OH F = Fate Study ; E = Effects Study P = Physical Property Study 2001 2002 2003 Work 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q F Hydrolytic Stability F Adsorption / Desorption (14C) F Aging / Sequestration (14C) F Aerobic Biodegradation (14C) F Anaerobic Biodegradation (14C) F Indirect Photolysis in Air CNRS E Acute Fish : Fathead Minnow done E Acute Invertebrate : Daphnia magna done E Biological Concentration Factor (BCF) (14C) complete E 90 Day Rainbow Trout Chronic E 21 Day Daphnia Magna Chronic E 72 Hr Algae Acute & Chronic done E Acute Earthworm (14 Day) E Acute Plant Seedling (21 Day) E Chronic Nematode (3 Day) P Water Solubility, UV/Vis, Vp, Sorption done P Temperature-Dependent Henry's Law Constant * This is a proposed timeline and subject to change. Work Complete Work Underway Work Planned Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 45 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI PFOA Potential Consumer Exposure Study The TRP will focus in two principal areas in an effort to determine whether PFOA may arise from consumer articles treated with telomer-based products. Consumer Articles Treated with Telomer-based Products Textile, Carpet, Paper Telomer-based Products used to "treat" the Consumer Articles Acrylic Polymeric products are used most commonly in these applications The "Telomer" functionality is introduced via an acrylic monomer bearing the Telomeric, F(CF2CF2)nCH2CH2-, group Other relevant Telomer product types are Urethane Polymers and Phosphates Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 46 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI PFOA Potential Consumer Exposure Study Action Plan Overview Samples : Actual Consumer Articles : representative textile, carpet and paper articles from each TRP member company Product : the actual products that were used to treat the above consumer articles Analytical Methodology: A specific method will need to be developed for each substrate (textile, carpet, paper) and product matrix Method development will establish LOD and LOQ May need isotopically enriched (13C) and other chemical standards Analysis to be done by third-party laboratories - will need to find and "qualify" labs Timing: Goal is to have the majority of data analysis and interpretation by April 2003 Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 47 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI Conclusions, Discussion, & Questions Telomer Research Program (TRP) Company Sanitized 25 Nov. 2002 48 Asahi Glass, Clariant, Daikin, DuPont Does not contain TSCA CBI