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M a&G- RECEIVED OPPT NC!C Telomer Research Program Meeting, February 3, 2003 NAME ORGANIZATION TELEPHONE # 2003 APR 2 7 ?h 2 :1 ,5 E-MAIL ADDRESS E M / dPPT t?2 5~/y~SV?/ Ze?hZt' *AAa/ t va k#/ *?{k\, ^ tv l't(& yM sVeZ L /M P m j t T i^VAWI^O <a V A 0 0 " 5 I^M2.Vtd\t f } b / Y \ \ G i t t m cL j T C #k ) 6c bb\ f j A (ft m a n Kdtil S o u /tty . 1 ..........Q * \a Ca^ ~t>r"`>*'fti<-- .'Etc Za WaW a,S>T\aW<VS^V\ 0 Cx u ^ A u U K < V ^ rA j{o ^ ( 4,^ ^G ^S n JltA ^^I/L vjf ^v-\. 6a S--c-t? J y U h' f / % . U e ^ j / i ^ i ^ JSTA 'v w X i 16* f / l <fL4 b U o / u a u i i c ^ , , o r c ^ y <p <s }**-.<; ss aO o f* v q q < rf < S 3 3 H i e . , F b\ - bfe? u-s-41 mp7iicc P)/H \o /\j 7 /7 - J ir - v V v o U\HPf&JT & L/H P <& -r- J A/A^J . o/y 4 ffc r/u /AtSiaUf i- c/ ,H/<35^ ) 7 o / - V<E?_ ft?/ PftAo* l \ "UHehVo, , CO iciuV\i<5^v f (2 \S *bl ^ (a rs . r ^ t Z1/.-I /..:. |, a 7 ^ 3iS OS 7 Ca t t i M u a . f l f ) p e e i) <0l l S f l . c k i f r v h hcbijix_, Hinn / i i c u . 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E/A ( o P P T / ccE) G alore p /c g flB -4 .\\n 0 x S U ^nuA-fcliu 6> m o d . ora ja-s'fc^'-Sr/V J o r j P ii - /o y / Oo/ 70 ' 5 6 / ~S/f 5Up?mUiKt'ifie#ftKAru-^j 3/ **OA./ O*i/>\/ c . b ^ c( 1d e (p5 p^ ^ o \J a "^ A f ^j ilr u /^ JrU -Q ^ E fft t C r b ) fj\ E P A 1/ o p Pt V/ ^ A b' fr9/ / /v /* e f f t - h f t r /iti* z-5Vf- SM /w t b l / . c k u s1 A > pt pc, . *r t d / 7/ s j r ^ c/ 'A1- cZV Zu2-5-CV'7^ 3 V S><r<?cA. , -Aa p z^S % 4~~^^3 Z e i- - ' IW *'e- f b i *^ .-f in / ^ L-Q ^4flS , kjej> J O tU s b tL ri? -' /2 & **y ; < f~ / % < G e e ^ ic ttJ ^ Q tH ^ f t h r j --* to p 5f (/ryay // r/ /KDi' P<K J W y & r w t n - tp e w a ^//O ~ 1 /A j rdi-^1JC-f-d iA TSi\f, i,irfv\ / / Telomer Research Program Meeting, February 3, 2003 NAME O R G A N IZ A T IO N Hobt r i 'buck 2)u?otrf Q'itVt KfZti/UCiJSki 2)uPanf' t jo '' //1a (Vnrk r c ifp -r -e m TELEPHONE # E-M AIL ADDRESS 3 Q9. 84$ & 5 6 fobici- . i>u(k@UIa.duporri.CQnt 9- BCf'iZ' siephm. h*KerzenieuiSkt ^ ,M<*LporrK,cQt*> Q o . S - GH ^ 7 obrer* s ) a cg. <-; o* 5 W 3T/0 zSrt'h/ltfV'd-er, fyirt/YZlrs'/ (k?>*2. GcT Y Nj ' J c NO CB T R P Telomer Research Program ^ Clariant 3 February 2003 Presentation to U.S. EPA - OPPT 3 Telomer Research Program g g |ij( TRP Presentation OiLitiine Introduction Information Sharing Product & Article Analysis Telomer Manufacturing In-Use Mass Balance Issues for Discussion Metabolism & Degradation Closure & Path Forward 2003-02-03 , page 2  Expectations Alignment Path Forward 2003-02-03 , page 3 Telomer Research Program TRP has a database for collecting and sharing scientific information Types of Information we have Member Company Information TRP Study Reports Public Literature Relevant Unpublished Reports (non TRP) 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? 2003-02-03, page 4 G Telomer Research Program Information ; Submissions to Date 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 Study Reports (8-2 TBA): January 2003 Acute Oral Toxicity In -vivo Rat micronucleus Assay Reverse Mutation Assay 2003-02-03, page 5 7 Telomer Research Program Information : Study Report Timeline 8-2 Telomer Alcohol February 2003 Acute Aquatic Studies : Fish, Daphnia, Algae Respiration Inhibition Hydrolytic Stability . M E T IB C F Study Univ. of Toronto Progress R eport: 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 2003-02-03, page 7 2 Telomer Research Program January 10,2003 TRP Letter Proposed Workstreams for 2003 2003-02-03 , page 8 1  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 2003-02-03, page 9 to Telomer Research Program Product & Article Analysis : Direct Analysis : Workstream Develop and demonstrate sampling and analysis methods for Products & Articles Isotopically enriched (M+2) PFOA standard C6F1313CF213COOH 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 2003-02-03 , page 10 ll Telomer Research Program Tier II - Potential for Human Exposure via Articles . conditional . dependent upon Tier I results, review and discussion with EPA 2003-02-03 , page 11 Telomer Research Program Processes : Intermediates to Finished Products Potential PFOA Releases & Occupational Exposure Industry Mass Balance and Production Data Major Consumer Uses 2003-02-03 , page 12 13 Telomer Research Program Telomer Manufacturi - y ^ i k s j b I^hsi j i r - f E y J g ii jiSffg ^ I I . m~ u n Tu fj fjyjT i1' j j iif _ i T I 1 1 ifH's' ' **s^-- T * I * c f 2=c f 2 Tetrafluoroethylene) Telomer Intermediate "Building Blocks" F(CF2CF2)nl Telom er A Iodide n = 2 -8 F(CF2CF2)nCH2CH2l Telom er B Iodide F(CFpCFp)nCH=CH2 Telom er B Olefin ! Actual Process practice varies by company Do not use or add PFOA in the process Generally, these processes are closed and PFOA creation &/or emissions are expected to be de minimus Manufacturing activities occurring within the U.S. will be communicated to EPA by individual companies under confidentiality Telomer Research Program 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 Need EPA contact to set meeting date/time 2003-02-03, page 14 JJT  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 Environmental Releases 8-2 alcohol atmospheric degradation pathway(s); report in 2 months 2003-02-03 , page 15 / Telomer Research Program Telomer Production Data - 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 85% of 8-Fluorinated Carbon based products are polymeric 2003-02-03, page 16 /7 Telomer Research Program Issues for Discussion Feedback and Alignm ent: 8-2 Telomer B Alcohol Workstreams - 2003 . Pharmacokinetics . Further mammalian toxicology tests (i.e.muiti-gen) . Environmental Fate Studies . Environmental Effects Studies Screening Studies . Blood data . Biodegradation 2003-02-03 , page 17 IP Telomer Research Program 8-2 Telomer B Alcohol-14C 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 2003-02-03 , page 19 if  Modified OECD 301D Closed Bottle Test - a Mass Balance Investigation with Radiolabled Substance 2c7 f1514cf2 ch2 ch oh 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(CF2)8CH2COOH, F(CF2)7CF=CFCOOH, F(CF2)7COOH will be quantified Analytical methods will meet FDA & EPA data accuracy and precision 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 pg/L after 28d of test duration results show no PFOA 2003-02-03 , page 20 ciO  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 2003-02-03 , page 21 o2/ Telomer Research Program 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 2003-02-03, page 22 AS. Telomer Research Program Proqram and workstreams agreements between EPA andj ' VTRn Pn . 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 2003-02-03 , page 23 <23