Document DaYmG5zGaewJ7GX1rZq80124

M .3.6- 1099 ^5^37^ The Society of the Plastics Industry, Inc. Suite 600K 1801K Street, N.W. Washington, D.C. 20006 AEllxeencuCti.vWe Deiirdemctoarn Friday, April 26, 2002 Ms. Mary Dominiak Chemical Control Division (7405M) US Environmental Protection Agency Room 4410-M 1201 Constitution Avenue, N.W. Washington, DC 20460 25ZrXvo3O ~oo crVro~>.r2C.2 CP Subject: Fluoropolymer Manufacturers Group Presentation Slides Dear Ms. Dominiak: On behalf of the Fluoropolymer Manufacturers Group (FMG) I am sending you the original and redacted copies of the presentations given today by David Rurak and Gerald Kennedy. Some CBI notes: 1. This letter is not CBI. 2. The copy of the sanitized version of the presentation is so marked and three blank slides were inserted to replace the CBI redacted slides. 3. The copy of the presentation containing TSCA CBI is contained in the inter enevelope and is so marked on the enevelope and the title page of the presentation. I hope that this information is sufficient for your needs as this time. If there are any other questions, pElPeaAseindtohinsoitmhpeosirttaatnettmo actotnert.act the Society of Plastics Industry. We are committed to working with the Sincerely, 9& 5 c3 to o o ( S ' 5 = --. o----a>oiponr"i 3C Oo C kD cn er> I Company Sanitized RECEIVED OPPT C3IC FMG Presentation to EPA April 26, 2002 Sanitized Copy Three Blank Slides w/CBI Redacted 9* 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. Agenda Risk Assessment Approach APFO Environmental Distribution - Potentia Exposure Routes Reductions in Environmental Releases Industry Efforts Future Activity Question? Are PFOA Serum Concentrations from Rat Toxicological Studies Useful in HumanHealth Risk Characterization? 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. Serum Concentration Illustrative Clearance Curve 7 Other Examples (Females) 100 % of an oral dose of 14C-PFOA in pregnant rats was recovered in urine within two days. Female rats excreted essentially 100% of an i.v. dose of 14C-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. 8 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 humanhealth risk characterization. il 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. U Question? How is PFOA distributed to the US population? (Auer, 1/30/02) Possible Sources of Exposure 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 /r U.S. APFO Manufacturing Summary Significant Reduction in Capacity 3M Production 227 tonnes (500,000 lbs)/yr New US Capacity < 136 tonnes (300,000 lbs)/yr 40% Reduction in Capacity vs. Actual 3M Production Significant Reduction in Emissions 3M Emissions < 21 tonnes (46,950 lbs)/yr New US Capacity Emissions < 0.5 tonnes (1000 lbs)/yr ' 98% Reduction Significant Reduction in Alternative Uses 3M non-Fluoropolymer industry global sales - 6 tonnes (12,500 lbs )/yr New US Capacity non-Fluoropolymer industry sales - Zero Possible Sources of Exposure 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 Possible Sources of Exposure Blank Slide CBI Redacted Blank Slide CBI Redacted Possible Sources of Exposure 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 12> Blank Slide CBI Redacted Possible Sources of Exposure 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 Possible Sources of Exposure 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 Possible Sources of Exposure 98% Reduction EnEvxiproonsumreent OA liOmpSf^aFt^etriae!es <mi >50% Reduction FMluoanroupfaoclytumreer Dispersion \/ Telomer y MBataesreidals \ / ftooTrmPraFanOtsi-oAn W PMPooapitnuetrlaiSatoilouFnrlcoEewxEpmosisusrieons PEoGxpepunoleasrutairolen Significant Reductions More Study Planned Question? How is PFOA distributed to the US population? (Auer, 1/30/02) 3o 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 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 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