Document 068QJBYbe5gX6ey4jXdd9bqax

& AR2222G6_ 1304 DonalKdP.reDsuindceannt iTrnedy 26 if March 14, 2003 "A"TTshhseeisUHtnoainntoterAdadbSmltieantiSesstterEpanhtveoinrroL.n Johnson mental Protection Agency, Headquarters O1f2f0i0cePoefnPnrseyvlevnatniioanA,vPeensutiecides and Toxic Substances WRaosohmin7gi1o0n1,MDC 20460 g3 22 3s 35 =- ZB5o3 2 28 b=d = Dear Mr. Johnson: IDnytnenetondeOsLncLrCib;bieannghdtoahEf.ltiIh.fneidtuiAastPaiovhneits GdhleaatsNstehmFeolsueuorcrsoompaponaldnyiCmeoesrmsphaaUnvSyeA,f,awIkenecn.arteoDaatisrskainissntmiAEtmPteiArnigicnaa,iLtesItnacts.esreosfsment auofnmpdmeeorrfnwliauuyormtooopdceteravfnleoulioorepoaoiccnitfdaonracmanatteiiosinnstaahnsed. mdaaTnthuaifsnaecLteeudtreeedr,tdpoersaocscrseiusbrseeisntghi,ne ascnoodnmteuisndeueotefadillsautfoheerouaspcetoilovyiftmieerss "The Soci1etyyooufthhaevePlaansytiqcuseIsntdiuosntsrya,boIunct.t(hSePLTe)tatter20o2f-I9n7t4en-t5,2p3l3e.ase contact Lynne R. Harris, of Enclosure cei MChaarrgleasrMeN.t.ASucehrneider A on Don Duncan mitted, WT1ah6se0h1iSnoKgctiSoetnte,yero,DfCNthWe2,0P0lSa0ust6tei1c3s600I10ndKustry, Inc. d1i6nt1pc3m02e.s9o74c.pp5li2a5as2sicourntsodxus2t0r2y9o3rg.0300 OONTAIN NC CRI J March 14,2003 Regular Mail The Honorable Stephen L. Johnson Assistant Administrator `The United States Environmental Protection Agency, Headquarters Office of Prevention, Pesticides and Toxic Substances 1200 Pennsylvania Avenue Room 7101M Washington, DC 20460 Re: Voluntary Actions to Evaluate and Control Emissions of Ammonium Perfluorooctanoate (APFO) Dear Mr. Johnson Asahi Glass Fluoropolymers USA, Inc.; Daikin America, Inc. (Daikin); E. I. du Pont de Nemours and Company (du Pont), and Dyneon LLC (Dyneon) (the "APFO Users") each use aUSmSm.onFliuuomroppeorlfylmueorrosoacrteanpolaatsteic(ApProFdOu)c'tstowhpirloedufcleuofrloueolraosptoolmeyrmserasreanrdubbfelru-olriokeelapsrtoodmuecrtss,inbothteh. of which provide highly desirable and unique properties that make the end-use products created from them useful. Allof these companies are membersofThe Societyofthe Plastics Industry, Inc. (SPI) Fluoropolymers Manufacturers Group (FMG) and its Fluoropolymers Division (FFD). Together, they and/or their parent companies represent, both globally and in the U.S. most of known use of APFO for productionoffluoropolymers. high-peArfPoFrmOanisceesaspepnltiiaclatiinonmsakinincrgitciecratlaiinndfuslturoireospsoluycmhearss,d?efwehnisceh,,aeinrotsupma,cea,reseumsiecdonindumcatnorys, telecommunications, and pollution control. A listofcommercial fluoropolymers is provided in Addendum Io thisdocument. Many gradesof these fluoropolymers can be made only with APFO. understTanhdeaAnPdFaOsseUsssertshesthoaxriecitthyeofgoaanlodfetxhpeosUu.rS.esEtnovtihreonAmPeFntOalusPerdotbeycttihoenfAlgueonrcopyo(lEymPeAr) to hinadvuestmrya,deansdpetcoifsiacfecgoumamridthmuemnatns thoeaplrtohvainded atdhdeietinovniarlonimnefnotr.matTioonthaantdenrde,setahrechAPtoFEOPAU.serTshese p1entadecaTflhueorAoP-,FaOmUmsoenrsiuusmesaaltc,omCmAeSrc3i8a2l5l.y2a6v.a1ilable formofthe compound, technically known as octanoic acid, 2distinctioFnotrhapturnpeoesdesstooftbheimsadleet.ter,wewill use luoropolymers to include floroclastomers, unless there is a 2X The Honorable Stephen L. Johnson March 14, 2003 Page20f 15 commitments are: (1) to reduce emissions of APFO from fluoropolymer and APFO mmaanduefafcrtoumritnhgesfeacrielsiitniess;to(2d)etteorcmoinndeuicftasntyudeixepsoosnurbeottoh tfhienigsehneedrraelsipnospualnadtifoinnicsahnedbperroedluacttesd to the fluoropolymer industry; (3) to conduct studies on emissions from fluoropolymer processing facilities to determine the levelofcurrent emissions; and (4) to develop additional toxicological data on APFO. This Letter of Intent includes timetables for completionofvarious studies and research, including additional studies on the toxicity and environmental fateofthe substance. The timetables are the best estimates available at this time. The APFO Users will promptly provide EPA with the information as it is developed so that it can be made available to the public generally. Addendum 11 describes the history of APFO use in the fluoropolymer industry, the reasons for the recent interest in APFO, and the extensive activities that the APFO Users in the industry have completed, and continue to conduct, to protect human health and the environment while society retains the substantial benefitsoffluoropolymers. Current Activities of Fluoropolymer Manufacturers The APFO Users believe that fluoropolymers and products made from them are safe for their intended use. Nevertheless, the companies are examining the use of APFO more closely. Initially, the APFO Users, in conjunction with the FMG, determined that they needed to find out how much APFO was used and how much was emitted to the environment, as well as to rcexamine work practices in their own plants. Thus, the FMG prepared a global materials balance including APFO used in manufacturing fluoropolymers. `The information developed from the materials balance was provided to EPA in 2001; it was updated in 2002, and will be revised in the future as described below. The global materials balance was and is based on the best available evidence that the companies have regarding the use of APFO in making fluoropolymers and the fateofthese substances in the fluoropolymer industry. Based on these estimates and the method used, the companies have accounted for essentially all the APFO used in the fluoropolymer manufacturing industry. As responsible manufacturers, the APFO Users are committed to reducing APFO emissions. Based on that global materials balance, and as described below, FMG members have voluntarily begun to modify their processes to reduce AFPO emissions, on a global, individual `company-wide basis, by a minimumof50% for calendar year 2006. This reduction will be compared to baseline data submitted to EPA in September 2002. This initial commitment was based on the best information available to the companies at the time of the decision and what the `companies believed could be achieved, even with some difficulty, given the available technology, the characteristics and usesofthe surfactants and the nature ofprocesses involved. 3 `The Honorable Stephen L. Johnson March 14, 2003 Page3 of 15 Using data collected from the materials balance and such environmental monitoring and other studies as they become available, the companies will continue to use appropriate criteria, including such standards, limits or parameters as the West Virginia air and water screening levels and water quality guidelines, to evaluate operations and emissions. continueTtoofpacriolviitadtee ttoheFcMoGmmciotmmpeanntietso rwehdeurceeneemeidsesdi,onist,s "dcuapPtounrtehfaosr pdersotvriudcetdi,oann"dtewcilhlnology, license-free. In addition, Dyneon and du Pont each have offered to license their respective. `company's "capture for recycle" technologies. All of the companies are evaluating the applicabilityofavailable technologies to their processes and continue to track APFO emissions Becauseofthe differences in the manufacturing processes and the kindsofproducts `manufactured, it is not possible to know whether these technologies will be effective, or if they are, what `minimum the final reductions 50% reduction and will be. Nevertheless, the companies are committed to taking additional steps as described below. to the `The APFO Users, through the FMG, also continue to support research on the toxicology, ccotoxicology, and environmental fate of APFO, as such research relates to the safe use of APFO as surfactants in the manufacture and use of fluoropolymers. Collectively and individually, the FMG members have worked with customers to help them safely manage the processing of fluoropolymer products, and to help them adopt practices and procedures to control employee exposures. These activities are essential parts of long-standing product stewardship programs and are ongoing, as described below. In addition, the APFO Users have, and are, committed to working to identify the possible routes, related to the manufacture, processing, and use of fluoropolymers, by which the general population could be exposed to APFO. The APFO Users have begun to examine their products, embarking on the difficult analytical processofdetermining any residual levels. The frst step in this effort was to evaluate methods for analysisof APFO. The method evaluation work is under way, which is necessary to meet EPA's QA/QC criteria and is difficult and time-consuming. As partof that effort, the FMG published in January 2003 Detecting and Quantifying Low Levels of Fluoropolymer Polymerization Aids ~ A Guidance Document. A copy of this document was provided to EPA's technical staff for inclusion in the docket under separate cover. `*governmeTnth,e itnoxdiecpoelnodgeinsttshaindd spcairetnytiesxtpserwths,oapnardtiicndiupsattreyd.intThheeasorsgeasnsimzaetnitonisncrleupdreesdernetperdesiennctlautdiedv:esWfeisotm Virginia DEnevpiarrotnmmeennttoaflEnrvoitreoctnimoenntAaglenPcryo,teRcteigoino;nTIoxicUoSl.ogAygEexncceyllfeonrcTeofxoircRSiusbksAtsasnecsessmaenndt,DiCsienacsiennRaetg,isOthriyo;;EUPSA. National office inWashington;and EPA's Cincinnati Laboratory. 4 `The Honorable Stephen L. Johnson March 14, 2003 Paged of 15 Further Industry Commitments A. General Commitment to Product Stewardship Principles and Practices The APFO Users will continue to follow the principles of product stewardship similar to MthaonsuefadcetsucrriebresdAbsysoAcmieartiiconasn (ChSeOmCiMstAr)y CRoeusnpcoinls'isbl(eACCaCr)eorpSryongtrheatmisciOnrtghaeniirccfCfhoretmsitcoalsupport the toxicological research, control occupational exposures in their own facilities, monitor employee health, assist customers in protecting their employees, and meet the general commitment to reduce emissions to the environment. For example, as has been done in the past, through the semi-annual SPI FPD meetings, an update on information about APFO, including the results of toxicology studies, coordination efforts with EPA, and other activities, will be provided to processor membersofthe fluoropolymer industry. High on the list of topics will be an emphasis for fluoropolymer users on the need for care in handling and processing the raw fluoropolymer products, and the need to follow recommended procedures to protect their employees. Special attention will be given to address the practices and proceduresof those who use dispersions and coatings made from dispersions on the safe handling ofproducts that contain APFO. In addition, as part of their `workplace product stewardship efforts described below, the APFO Users, working with the FMG, will continue to update and distribute the manuals and information documents described. Further industry efforts on product stewardship programs directed to customers will focus on technical support and assistance to fluoropolymer processors to help them keep their occupational safety and health programs current. While APFO Users recognize their responsibilities as suppliersoffluoropolymers, each processor and customer, as an employer, has an independent and non-delegable duty to take reasonable steps to comply with OSHA standards, and where there is a recognized hazard that is not addressed by specific OSHA standards, to assure that their employees are protected from safety and health hazards. Accordingly, the fluoropolymer manufacturer's product stewardship role is to provide the necessary information, assist in the understandingofit and provide support to processors using the fluoropolymers so they can meet their statutory obligations. Specific steps and studies are described below that demonstrate how the APFO Users will meet their obligations under product stewardship principles. `The APFO Users generally will submit information to and work with EPA through the SPIFMG. Such information and studies may be conducted under the auspicesof industry groups such as the Association ofPlastics Manufacturers in Europe (APME). The APFO Users will share the information we develop with EPA. As described below, the FMG continues to work on additional studies that will provide useful information to assess any potential OefnvEiPrAon'mseenftfaolrtasnadndheianlttehnedffteoctasssoufreAtPhFatOEuPsAedhians faldueoqruoaptoelyimnefrosr.maAtiPoFn OtoUusnedresrsatraensdupthpeortive benefits, and any risks, of APFO use in fluoropolymers. :5 `The Honorable Stephen L. Johnson March 14, 2003 Page Sof 15 B. Data Quality APFO Users recognize the importance of assuring good data quality. EPA's recently issued QA/QC Guidelines* information made available describe EPA's to the public in efforts to maximize termsofquality, int the egri qualityofenvironmental ty, reliability and validity of the data disseminated. APFO Users will incorporate the guidance contained in EPA's QA/QC guidelines into their research and monitoring programs to assure that sound scientific information is available to EPA and the public. C. Specific Commitments 1. Supporting EPA Efforts to Involve CDC in Testing Programs `The APFO Users support adding APFO to the CDC NHANES process. To facilitate that step, work is underway to confirm the validityofthe analytical method and sampling protocol for analyzing human blood for the presence ofAPFO, and the results will be shared with CDC. Efforts will be made to have the analytical methodology published in a peer-reviewed journal so it will be widely available. In addition, and in the further interest of adding transparency to the process, there will be support and assistance for one or more independent laboratories to become qualified to perform the validated method. 2. Toxicology Research Under the auspicesof the APME, the following additional studies will be completed on the schedule noted: Chronic toxicity in daphnia "Adsorptionidzsorption soll SHES "ADE mass balance in rats Protein binding; ravhuman Anticipated Report Dat May 2003 May 2003 JJuulny e22000033 November 2003 June 2003 August 2003 Di#ssemina"tGeudibdeyltihneesEfnovriErnosnumreinntgalanPdroMtaexctiimoinzAignegntchye.Q"uaalnintoyu,nOcbjeedctiniv6i7tyF,RU.til6i3t6y,57a,ndOcItnotebgerrit1y5o.f20I0nf2o.rmQautiaolni f7"ssurancBeafsoerdDoantacoCmolmlietcmtieonnt;s5f3r60o.m1c/oAn2trMacatyin2g0a0b0oratoris, we believe thse dates can be met. EPA wil be advised ofany changes in the reporting schedule. `The Honorable Stephen L. Johnson March 14, 2003 Page 6 of 15 Study Description Physiologically based kinetic modeling Mechanistic studiesof pancreatic tumor induction in rats. `Anticipated Report Date October 2003 October 2003 Iexntdruasptorlyaptliaonns(otroaclotnodiunchtalaantiaodnd)i,tiaonndalthsetpurdoyttoocodletwearsmidniescpuasrsaemdetweirtsh fEoPrArosuctiee-nttios-trso.utTeiming for the anticipated report date will be communicated when the final bid for the projectisaccepted. Copiesofthe final reports for these studies will be submitted to EPA promptly upon riencfeoirpmt.atiEoPnAdewvielllobpesaapsparirseesdulit mofmtehedriesaetiarfecalhnyyprosugbrsatmanstciaolnlsyisnteenwt awnidthuncaunrtrienctipraetqeudirements; the above schedule does not,ofcourse, supersede any statutory reporting obligations. Following EPA's QA/QC guidelines, the reports will include documentation to allow EPA to evaluate the validityof the studies. This validation will enable EPA to assure that the information provided by the companies can be disseminated to the public consistent with EPA's odfatthaeqsuealsittuydgiueisdteoliEnePsA. aTnhdrcooungshultthewiFtMhGE,PtAheonAPwhFaOtUasdedirtsiwoinlall pstruodmipetslwyosuulbdmibte bfiennaelfirceipaolr.ts 3. Understanding Routes of Exposure Although there is no known evidenceofadverse human health or environmental effects to date related to APFO, the APFO Users agree with EPA that it is useful to examine the potential for human and environmental exposure to APFO to determine where potential exposures may have occurred or currently occur. Such research will include, but may not be limited to (a) sites where APFO is manufactured; (b) sites that use APFO to make fluoropolymers; () sites that use fluoropolymer dispersions containing APFO; and (d) articles of ccooamtmeedrpcreodcuocntst,aitnhiantgmfilguhotrolpeoaldytmoergse,neirnacllpudoipnugladtriyonfleuxoproospuorleymreelraptredodtuoctthseafnlduodrisoppeorlsyimoenr industry. D. Specific Product Stewardship Activities by Site 1. Product Stewardship at Sites Where APFO Is Manufactured in the U.S. `manufacCtounrseisAtPenFtOwiftohr ctohemmperirncciiaplleusosfeRienstphoenUsniibtleed CSatraetdes,(ianncyluAdPinFgOcuUrsreerntwmhaonudfeaccitduersertso) will first notify EPA and will review its product stewardship program with EPA covering the provisions listed in Addendum 111 to this letter, which applies only to APFO manufacturing. United SAtsaotfesthfoerduasteeionfftlhuisorloepteorl,ymoenrlymaonnuefaccotmurpianngy. haTshadtecciodmepdatnoymaisnudfuaPcotnutr,ewAhPicFhOalinretahdey has committed to adopting the steps in Addendum 111 as partofits operating practices. Because `The Honorable Stephen L. Johnson March 14, 2003 Page 7of 15 o`gfraonutpitsraunscttcioonnsaigdaeirnasttioansf,utAurPeFUO.SU.semrasnuafraeclteugraelrlythbaatrdreodesfrnootm asdeoepktinAgdtdoeenndfourmceIIaI nays kpiarntdooffits eopnefroartcienmgepnrtacatgiecnecs.ieTshaesyaanltsio-ccoampnentoittitvaek.e aHnoywesvteerps,tEhaPtAmiwgohutldbeacpopnesatrrtuoedhabvyetahdeeUq.uSa.teantitrust authority to assure that future in Addendum III and commit U.S. manufacturers to adequate product osfteAwParFdOsh,iipf.any, follow the provisions outlined 2. Product Stewardship at Sites in the U.S. That Use APFO To Make Fluoropolymers As noted above, the APFO Userscarly on made a specific and substantial voluntary Emissions Reduction Commitment regarding the amounts ofAPFO emitted from their `manufacturing facilities. Based on the baseline data from global materials balance submitted to EPA in September 2002, as described above, APFO Users, as FMG members, have committed to `modifying their processes to reduce AFPO emissions, on a global, individual company-wide basis, by a minimumof 50% for calendar year 2006. This reduction will be achieved by reducing the use, recycling a greater proportion, or by capturing and destroying it. In addition, at eachof the fluoropolymer manufacturing sites listed below, the APFO Users will: 1) Develop site-specific plans to assess or model levels of APFO in air and water around their manufacturing sites; developmentofthe plans will begin not later than 30 days after the dateofthis letter; 2) Conduct site-specific air dispersion modeling, using the EPA approved Industrial Source Complex Short Term 3 (ISCSTS) model, as described in EPA's Guideline on Air QausaselsistythMeordeeslulsts(4u0siCn.gF.tRh.e aPiarrtsc5r1e,enAipnpgelnedviexlsWe)st,abalnidshed in West Virginia; 3) Asnecessary to implement a site-specific plan, conduct ground and surface water analysis, and assess the results using the water screening levels established in West Virginia; and 4) Use the West Virginia screening levels to determine what additional actions,ifany, may need to be taken, after reviewing the information with EPA. `These commitments will be undertaken at the following sites: hip epa.goviscram00) guidance/guidelappe_OLpdf 8 `The Honorable Stephen L. Johnson March 14, 2003 Page8 of 15 a) duPont `Washington Works Plant Rt. 892 South Washington, WV 26181 b) Dyneon ) Daikin 1400 State Docks Road Decatur Alabama 35609-2206 905 State Docks Road Decatur, AL 35601 Six months after this Letter is signed, reports will be submitted by each company for each site on progress made with regard to environmental assessments. In addition, the APFO Users will: 1) Within 30 daysof this letter, providea list of cach site in the United States where APFO is used to make fluoropolymers and which fluoropolymers, including CAS numbers, are produced at that site; 2) For each listed site, beginning in 2004 for the 2003 calendar year and continuing through the 2008 calendar year, provide EPA with a biennial report, describing total emissionsof APFO at each site, on a calendar year basis. The reports will be submitted to EPA within 180 daysof the endof each reporting period and will include CAS numbers for the substances reported; 3) For cach listed site that uses APFO, continue to conduct industrial hygiene `monitoring in the workplaceoftheir employees, measuring exposure to APFO and providing results to exposed employees. The results will be used to assure that employee exposures are controlled and to protect employees" health. The companies, as they have in the past, will assure that appropriate protective `equipment and proper handling practices are used. They also will continue to provide employees with training on any hazards to which they are exposed, the signs and symptomsofoverexposure and methodsofproper handling, updating as new information becomes available, as part oftheir ongoing employee Occupational Safety and Health Administration Hazard Communication Standard programs. As further evidenceoftheir ongoing commitment, the APFO Users will provide EPA with timely reportsoftheir collective progress in reducing emissions and meeting the target goals so that the information can be made partof the public record. The reports will be based on estimates of annual emissions, derived from available sampling data and supplemented by best estimates when actual data are not available, compared to the original estimates provided to EPA. `The Honorable Stephen L. Johnson March 14, 2003 Page 9 of 15 The APFO Users long have followed American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) recommendations in assessing their occupational exposures to APFO, and they will continue to do so. As other recommendations tbheecpoamset,awvoairlkabtloe,entshuerAePthFaOt tUhseierrsemwpillloyienecosraproeraatdeetquhaetmeliyntportohteeicrtpedrobgarsaemdsoanndt,heasbetshteayvhaialvaeblien scientific evidence. `The APFO Users can provide EPA with details about their individual occupational safety and health and environmental compliance programs. If asked, each APFO User will review its environmental and occupational health data and will describe and provide the rationaleof its `monitoring programs going forward. 3. Product Stewardship at Sites in the U.S. That Use Fluoropolymer Dispersions Containing APFO `The APFO Usersarecommitted to continuing their Product Stewardship programs for their customers. To assist in assessing the potential routes ofexposure at selected sitesoftheir customers, the APFO Users, under the auspices of the FMG, will: 1) Engage a third-party consultant to develop a representative material balance for the fate of APFO contained in these dispersions. Similar to the information provided to EPA on fluoropolymer manufacturing, address in the representative. `material balance how the dispersion is used at the customer site and potential emissions ofAPFO to the environment; 2) Submit the material balance to EPA and work cooperatively to identify and cruesctoommmeernsditeasp.propriate product stewardship elements to control emissions at 3) Target completion ofthe material balance by the endof 2003. `This project is under way and the contractor is being selected. We expect that the results ofthe materials balance will suggest what actual monitoring maybe necessary. After the initial survey is complete, the companies will review the information to determineiffurther research or `monitoring is required, and,ifso, will work through SPI to help customers conduct their necessary studies. Among the tasks that need to be completed are: validating air sampling `methods applied to customer sites; providing analytical methods; and identifying consultants and laboratories with experience in collecting and analyzing workplace air samples for APFO. The /APFO Users will discuss plans for additional work in this area with EPA. Finally, consistent with the product stewardship principles to which APFO Users firmly adhere and whicharediscussed above, the APFO Users will continue to update information provided to customers and usersoffluoropolymers, make the information widely available and work with customers to assure that the information is disseminated downstream as appropriate. Industry meetings such as the semi-annual FPD meeting and other venues where fluoropolymer lo `The Honorable Stephen L. Johnson March 14, 2003 Page 100f 15 users participate will be used to communicate the need to be knowledgeable about fluoropolymers and APFO, and the need to take the recommended steps to reduce emissions from processor facilities and minimize potential processor employee exposures. 4. Product Stewardship for Articles of Commerce Made with Fluoropolymers Fluoropolymer products made with APFO are sold in eithear dry resin formoras a liquid dispersion. It is the intent of the APFO Users that APFO not be carried through the manufacturing and processing ofarticlesof commerce. To document that this is the case, the APFO Users, under the auspicesof the FMG, will: 1) Analyze representative articlesofcommerce containing or made with dry fluoropolymer resins for the presence of APFO and report the resuls to EPA. 2) For products coated or manufactured with liquid dispersions, analyze representative articles of commerce for the presenceof APFO and report the results to EPA. 3) As appropriate, develop and disseminate information along with recommendations to processors for reducing the potential for exposure to APFO from articlesof commerce. 4) Target completionof the analysisofarticlesof commerce by the endof 2003. These studies will be conducted by contract laboratories or in company laboratories using. validated methods. The products selected for analysis will be: (1) those most likely to have widespread consumer use; and (2) a representative samplingofindustrial and commercial products. `The articlesofcommerce being tested will be selected from products made with fluoropolymers supplied by APFO Users. There are some articles of commerce made from imported fluoropolymers that are not produced by APFO Users and also some articles of commerce made outside the US. from fluoropolymers not supplied by APFO Users. Based on preliminary data obtained using preliminary methods, it is our expectation that articlesofcommerce made from dry fluoropolymers will have no significant amounts ofAPFO present, and that most coated products will show similar results. An example can be found in the recent submission by du Pont to EPA showing that cookware coated with products made with fluoropolymer resins demonstrated no detectable level of APFO with current methods accepted by the U.S. Food and Drug Administration for analysis of food contact products. Based on these analyses, the APFO Users will provide EPA with potential exposure source and route information for public dissemination as it is developed. These data will be used to determine whether those sources contribute to potential exposure to the general population and to develop appropriate practices, methods, and measures to reduce and control the emissions of APFO. Again, these will be discussed with EPA as they are being developed. I `The Honorable Stephen L. Johnson March 14, 2003 Page 11 of 1S `The APFO Users appreciate the opportunity to work with EPA on this matter and agree that close coordinationof our efforts and sharing of information is important. Accordingly, we will continue to communicate with EPA as important relevant information arises and would appreciate similar consideration. ~As new information becomes available, the APFO Users are committed to work with EPA to take appropriate further actions in light of the information that is developed. In closing, we would like to emphasize that the fluoropolymer industry is committed to the continued safe manufacture, processing and use of fluoropolymers and to working with EPA. Respectfully Submited, APFO Users, attached Atiachments Addendum I: Fluoropolymers and Fluoroelastomers That May Be Made With APFO Addendum II: Background and Voluntary Activities Appendix I: Partial List of Studies on APFO in EPA's Docket `Addendum Ill: ManufactureofAPFO 12 The Honorable Stephen L. Johnson PMaagrech1214o,f210503 Opal NToimlee:: PCreosiedesntD.Allen Asahi Glass Fluoropolymers USA, Inc. 13 `The Honorable Stephen L. Johnson March 14, 2003 NameTEs -- Tite: Resident Daikin America, Inc. 14 `The Honorable Stephen L. Johnson March 14, 2003 Pa14gofe 15 rHsfhCaEl Nam#{JamesE. feGrdgory 1S `The Honorable Stephen L. Johnson March 14, 2003 Page 15 of 15 Name: ZL z Title: Vice resident General Manager E. I du Pont de Nemours and Company. 16 `Addendum 1 March 14, 2003 Page 1 of1 Addendum I [Pobymerfamily |CASNumber| Monomers | ep bsosrala fem JI E -- bsseoles [FERRE | (T Copolymers p-- oii-i7S 0 [EEVORA-- | [--Fepol--ymer-- s --ps1o0[T-EAF8P,VD5E .0| promises ore 127029-05-6 hme E,P | C I r TIri -- opes se -- -- ] 17 Addendum II Background and Voluntary Activities Background A. APFO Use in Fluoropolymers Ammonium perfluorooctanoate, or APFO, is a surfactant that acts as a polymerization aid to make certain base fluoropolymer resins. APFO is currently the most widely used surfactant for fluoropolymer manufacture and isessential in these processes. APFO typically is used in low `concentrations (less than 1%) in the fluoropolymer manufacturing process and ina few, very limited industrial applications. Because of its use as a polymerization aid, it is substantially removed in finishing steps in dry fluoropolymer manufacturing. In water-borne dispersions, `which are used to make various coatings, i allows applicationof the dispersion, but it is not intended to be partofthe fluoropolymer or the finished, end-use product. tis critical to understand the role of APFO in the fluoropolymer industry. The surfactant properties of APFO facilitate the manufacture of fluoropolymers and fluoroelastomers, but it does not contribute to the performanceof the end-use product. Therefore, it is not intendedtobe: ~or needed ~ in the end-use products made with it. In fact, mostofthe products made from fluoropolymers require heat treatment that removes or destroys the majorityof the APFO in the fluoropolymer resin before the products made with luoropolymers leave the manufacturing facility or are used. Therefore, fluoropolymer products do not normally present a routeofexposure to APFO once they leave the handsof the end-use product manufacturer. Further, APFO Users have long recognized their obligation to responsible use of chemicals such as APFO in their processes and products and long ago voluntarily committed themselves to establishing and supporting responsible health and environmental practices in the manufacture and useoffluoropolymers. This has been done to minimize the potential effect, if any, these activities have on human health and the environment, and to support the continued safe manufacture and useoffluoropolymers made using APFO. Those commitments continue today, and are exemplified by the additional commitments the APFO Users describe in this letter. Also important to understand is that, despite more than 30 years of intensive research into alternatives, none has been found, as was presented by du Pont representatives on behoaflThfe Societyofthe Plastics Industry, Inc. (SPI) Fluoropolymers Manufacturing Group to the U.S. Environmental Protection Agency (EPA) on April 23, 2001. Driving the research were considerations regarding persistence, the existenceofonly one supplier, and the need for more effective, cheaper alternatives. Indeed, fluoropolymer manufacturers have tested literally dozens of compounds, and all have been rejected due to technical problems or potential safety concerns that made them unsuitable for such use. 8 Addendum 11 Background and Voluntary Activities March 14, 2003 Page2 of B. The Roleof Fluoropolymers in Society Fluoropolymers are essential to a varietyof technologies and products that enhance `human life and promote environmental improvements. Ranging from power generation to emission controls on vehicles, to semiconductor chip manufacturing and aerospace applications, fluoropolymers provide superior performance in products that contribute to increased safety in our offices, homes, businesses, and communities. Fluoropolymers provide unique and critical performance properties in "system eriticalTM applications that protect and benefit people and the environment. Fluoropolymers arc among the few plastic materials that can withstand the temperatures inside the engine compartments of aircraft. They also have high resistance to a broad range of fuels, solvents and corrosive chemicals, as well as excellent electrical insulating properties. These unique properties provide critical performance characteristics needed to prevent fire, fluid emission, electrical overloading or similar emergencies in many high-performance applications. And, for virtually al these applications, fluoropolymers are the only materials that meet system performance needs in high temperatures and harsh chemical environments. C. 50 Years of Experienceof Safe APFO Use APFO has been used safely and without apparent adverse effects on human health for `more than 50 years, in part becauseofthe workplace safety programs the APFO Users had in place. This conclusion is supported by epidemiology and other human health studies (contained in EPA' public record and published in the scientific literature) on employees both at APFO production and fluoropolymer manufacturing facilities. Multiple studies, the first ofwhich was published in 1980, have examined the healthrelated experienceof employees in the APFO manufacturing process. These studies looked for health effects similar to the effects observed in animal studies. This effort continues even now. No studiesofthe employees who have direct exposure showed any unusual or unexpected pattemofillnesses or deaths from any disease, including cancer. Based on this experience, and the ongoing health and safety research they have supported `and that has been published over the years, APFO Users do not believe that current levels of exposure to APFO cause adverse effects to human health or the environment D. Recent Events Triggering Interest in APFO In May 2000, 3M announced that it would be "phasing outofthe perfluorooctanyl chemistry used to produce certain repellents and surfactant products." Subsequent to the 3M announcement, EPA broadened their interest in a series of fluorochemicals that they considered 10 be persistent in the environment. This interest has been heightened recently by the discovery that certainofthese fluorochemicals are found at trace levels in the bloodof the US population. 17 Addendum 11 Background and Voluntary Activities MarcPhag1e4,32o00f83 Voluntary Activities of APFO Users and Manufacturers "The users and manufacturersofAPFO have, both individually and collectively, supported research into the potential effects on human health and the environmen, and have adopted in their own workplaces health and safety practices to minimize employee exposure. They have funded research on the toxicology, both for animal and environmental effects and, as noted above, conducted epidemiology studies to be sure that human health has not been affected by the use of APFO. In addition, they have developed control recommendations for the safe use and handling of fluoropolymers and, specifically, for dispersions containing APFO. These recommendations have been disseminated to customers through publications and meetings of the SPI Fluoropolymers Division and the AssociationofPlastics Manufacturers in Europe (APME), in addition to the information provided individually by the APFO Users through Material Safety Data Sheets (MSDS) and other technical information sources. `The studies the APFO Users and manufacturers have funded were conducted on APFO aanndd daruelPaotnetdhcahveemiscuablm,itpteerdfltuoorEoPoAc.tanTohiec ancuimdb(ePrFoOfA)re.s"eaTrhchessetusdtiuedsieosn aArePFamOoinngcltuhdoesde itnhat 3M EPA's docket is large. Abrieflistofsome of the studies, including studies on human health assessments, is included in Appendix 1ofthis Addendum To coordinatetheirefforts to assess and respond to EPA's concerns, the manufacturers of fluoropolymer resins, who are also membersof SPP's Fluoropolymers Division, formed the FMG. The missionof the FMG is to promote the continued safe manufacture and use of fluoropolymers made using fluoropolymer polymerization aids such as APFO while establishing and supporting responsible use of fluoropolymer products and promoting environmental stewardship. The APFO Users, working with others in the FMG, will continue to support the safe use of APFO, will work with EPA to understand the information that exists and to develop. research programs to fil in the gaps `The APFO Users, as membersof the FMG, first presented information about the FMG's work to EPA in September 2000. Since then, the APFO Users, through the FMG and the APME, have continued to provide information on manufacturing, distribution and use of APFO, as well as the available data on systemic toxicity and environmental fate of APFO. APFO Users have reviewed EPA's preliminary assessmentofthe potential hazards to human health and the environment associated with exposure to APFO, entitled "Revised Draft Hazard Assessment of Perfluorooctanoic Acid and its Salts," dated November 4, 2002. The FMG has also provided but not alWl,htihleeeAnvPiFrOonmisentthealpranoducbtlouosdedsaimnpflleosrtohpaotlhyamveersb,eePnFeOsAteids.thPeFsOubAstiasnaclesoththaehcahsembieceanlftohutndhsin suosmuea,ly abseseingnteesdtOedPiPnTaSniDmoalcksettudNieusm,bbeercaAuRse22A6PFfoOr adlilsssoucbimaitsessiionnswaotnerpeirntfoloPrFinOaAteadnsdubasmtamnocensi.umARio2ns2.6 aElPsAo choanstains cdoonccuemrennitnsgpAePrtFaOinianrge dtoifoftehreerntpefrrfolmuotrhionsaeteadsscohceimaitceadlwsiutbhstthaneceost.hrTchheemAiPcaFlOsuUbssetrasnbceelsieivnecltuhdaetdthien EmiPlAteOrsPPTS Docket Number AR226. 0 Addendum 11 Background and Voluntary Activities March 14, 2003 Page dof EPA with a number of new documents and information about the useof APFO in fluoropolymers. A. Fluoropolymer Manufacturers' Product Stewardship Commitment The APFO Users specifically concur with and subscribe to the product stewardship principles similar to those described by American Chemistry Council's (ACC) and Synthetic: Organic Chemical Manufacturers Association's (SOCMA) Responsible Care programs. The APFO Users' product stewardship programs incorporate provisions (1) addressing the development and disseminationof health, safety, and environmental information; (2) adopting safe practices to limit risks to the community, customers, and employees from manufacturing and processing of fluoropolymer-based products; (3) establishing proper practices for effective health and safety management; and (4) instituting risk management approaches. These ongoing programs represent a substantial commitmentofresources and efforts, and the activities described below are evidenceof that commitment. B. Toxicology Research A numberofthe toxicology studies relevant to APFO that have been submitted to EPA, someof which were conducted in the carly 1970s, were funded by fluoropolymer industry `members, including the users and manufacturers of APFO. More recently, the studies conducted were organized and coordinated by the Toxicology Working Groupofthe Fluoropolymer Committee of APME. These studies, contained in AR226, examine acute and chronic health effects and include two carcinogenicity studies, a two-generation developmental and reproductive study, and studiesofeffects on tissues and organs, including in the liver, pancreas and reproductive organs, in laboratory animals. Other studies have provided information on the physical and chemical characteristics of APFO and its potential effects in a variety of species, including fish, microorganisms and other species. The APFO Users' commitment to support EPA's efforts is demonstrated through the FMG and the APME research programs. C. Workplace Product Stewardship Activities Directed Toward Protecting Fluoropolymer Manufacturing Employees As a matterof good industrial hygiene practice, the APFO Users have occupational health and safety programtso protect their employees, including those who handle APFO in fluoropolymer manufacturing. Over the years, as more information has become available, 3M has provided information on APFO to the fluoropolymer manufacturers, along with recommendations for proper handling and use. Among the most significant changes in handling was the decision to sell the substance in a wet form to reduce dusting and thereby employee exposure. Additional precautions to prevent skin contact and otherwise limit exposure include: the useofprotective clothing, gloves, face shields, and respirators, disposable garments, installation ofgeneral mechanical and local exhaust ventilation systems, and other handling practices as recommended in the manufacturer's MSDS. These precautions, the effects of 2/ Addendum 11 Background and Voluntary Activities March 14, 2003 Page 5 of8 APFO, and other important information are discussed with employees as part of ongoing Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) programs and on MSDS and product labels. All the companies adopted these various practices to keep employee exposures below the current American Conferenceof Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV)ofan eight-hour time-weighted-average (TWA) of 0.01 milligram per cubic meter (mg/n'). The companies have used industrial hygiene monitoring to document the efficacy of control measures and employee exposures as needed. The companies remain committed to meeting the occupational standards and guidelines recommended by organizations such as ACGIH as they are updated. D. Existing Product Stewardship Activities Directed Toward Customers APFO Users have long-standing product stewardship programs that incorporate the principles and practices similar to thoseofthe Responsible Care program as it applies to obligations to customers. They have worked collectively and individually to provide health, safety and environmental information to customers and distributors. Commensurate with product risk, they select and periodically review customers and distributors to foster proper use, handling, recycling and disposal as well as the transmittalof appropriate information to downstream users. Ifimproper practices involving aproduct are identified, the APFO Users work with the customer or distributor to improve those practices. Each of the companies evaluates its business relationships in light of these principles. `The APFO Users, with other FMG members, have worked for many years to assure that people who work with fluoropolymers have sufficient information to use them safely. As required under the OSHA HCS, the FMG companies have routinely included information about safe handlingoftheir products on MSDS, including information about toxicity, protective: equipment, and safe methods and practices. In addition, the companies have collectively worked to disseminate widely safety and health information using additional methods and documents, `going beyond what current law requires. One of the first collective efforts in this regard was the creationof a Guide (0 the Safe HandlingofFluoropolymer Resins (Safe Handling Guide) in 1992. A 3" Edition was published in 1998, incorporating the recommendations from all the manufacturers of fluoropolymer resins, and a copy already has been provided to EPA. Those recommendations included chapters on Potential Health Effects, Regulations, Safety Measures, Waste Disposal, and Emergency Measures. Although focused on fluoropolymer resins, the Guide includes information on some ingredients, including surfactants, used in fluoropolymer resins. Health effectsofsome byproducts also were included. `The Chapter on Safety Measures has extensive discussionsofsteps to take to avoid exposure to hazardous chemicals that might be present when processing fluoropolymers. Specific emphasis was placed on using local exhaust ventilation because of the by-products of thermal degradation, and information was provided on specific processing activities and their RW Addendum 11 Background and Voluntary Activities MarcPhag1e4,62o0f03 unique associated hazards. Recommendations included required protective clothing and equipment, such as respirators and gloves, as well as other garments to prevent skin contact. Finally, an extensive education effort was conducted through SPI FPD's semi-annual meetings. and seminars on the Safe Handling Guide and its updates. "The effort to update the Safe Handling Guide, now in its 3rd Edition, and other documents is an ongoing process that normally involves processor members of the FPD. Information on APFO will be included and highlighted. In addition, the FMG prepared and published its Guide to the Safe Handlionfg Fluoropolymer Dispersions in October 2001 that describes APFO and related compounds and their use in fluoropolymer dispersions in detail. This document is currently being updated and a revised copy will be provided as soon as itis available. 23 Addendum 11 Background and Voluntary Activities March 14, 2003 Page 7 of Appendix 1 Partial Listof Studies on APFO in EPA's Docket Studies funded by APFO Users and manufacturers: 1) Fayerweather, "Liver Study of Washington Works Employees Exposed to C8: Resultsof Blood Biochemistry Testing," January 15, 1981; 2) Gortner, E.G. (1981). "Oral Teratology Studyof T-2998CoC in Rats." Safety Evaluation Laboratory and Riker Laboratories, Inc. Experiment No. 0681TRO110, December 1981; 3) Gortner, E.G. (1982). "Oral Teratology Study of T-3141CoC in Rabbits." Safety Evaluation Laboratory and Riker Laboratories, February 1982; Inc. Experiment No. 0681TB0398, 4) Riker (1983). "Two-Year Oral (Diet) Toxicity/carcinogenicity StudyofFluorochemical FC-143 in Rats." Riker Laboratories, Inc., Experiment No. 0281CRO0012, May 1983; 5) Staples, R.E., Burgess, B.A., and Kems, W.D. (1984). "The embryo-fetal toxicity and teratogenic potential of ammonium perfluorooctanoate (PFOA) in the rat." Fundamental and Applied Toxicology, vol. 4, pp. 429-440; 6) York, RG. (2002). "Oral (Gavage) Two-generation (One Litter per Generation) Reproduction Study ofAmmonium Perfluorooctanoic Acid (PFOA) in Rats." Argus Research laboratories, Inc. Protocol Number 418-020, March 26, 2002; Studies funded by APFO Manufacturers: 7) Gilliland, F.D>. (1992). "Fluorocarbons and Human Health: Studies in an Occupational Cohort." Doctoral dissertation. Minneapolis (MN), University ofMinnesota; 8) Gilliland, F.D. and Mandel, JS. (1993). "Mortality among employees ofa perfluorooctanoic acid production plant." Journal of Occupational Medicine, vol. 35, pp. 950-954; 9) Gilliland, F.D. and Mandel, J.S. (1996). "Serum perfluorooctanoic acid and hepatic enzymes, lipoproteins and cholesterol: a studyofoccupationally exposed men." American Journal of Industrial Medicine, vol. 29, pp. 560-568; 10)Olsen, G.W., Gilliland, F.D., Burlew, M.M., Burris, J.M., Mandel, 1S. and Mandel, JH. (1998). "An epidemiologic investigationofreproductive hormones in men with occupational exposure to perfluorooctanoic acid." Journal ofOccupational and Environmental Medicine, vol. 40, pp. 614-622; 11)Olsen, G.W., Burris, J.M., Burlew, M.M., and Mandel, 1H. (2000). "Plasma cholecystokinin and hepatic enzymes, cholesterol and lipoproteins in ammonium perfluorooctanoate production workers." Drug and Chemical Toxicology, vol. 23, pp. 603-620; 12) Alexander, B.H. (20012). "Mortality Study of Workers Employed at the 3M Cottage Grove Facility." Minneapolis (MN), Universityof Minnesota; 13) Alexander, B.H. (2001b). "Mortality Studyof Workers Employed at the 3M Decatur Facility." Minneapolis (MN), University of Minnesota; 2h Addendum 11 Background and Voluntary Activities March 14, 2003 Page8 of8 14)Olsen, G.W., Logan, P.W., Simpson, C.A., Burris JM, Burlew, M.M., Lundberg, J.K., and Mandel, J.H. (20012). "Descriptive Summary of Serum Fluorochemical Levels among Employee Participantsofthe Year 2000 Decatur Fluorochemical Medical Surveillance Program." St. Paul (MN). 3M Company. U.S. EPA Docket AR-226-1030a020a; 15)Olsen, G.W., Burlew, M.M., Hocking, B.B., Skratt, J.C., Burris JM., and Mandel, J.H. (2001b). "An Epidemiologic Analysis of Episodes of Care of 3M Decatur Chemical and Film Plant Employees," 1993-1998. St. Paul (MN), 3M Company. U.S. EPA Docket AR-226-1030202; 16)Olsen, G.W., Burris, J.M., Burlew, M.M., and Mandel, J.H. (2003). "Epidemiologic assessmentofworker serum perfluorooctanesulfonate (PFOS) and perfluorooctanoic acid (PFOA) concentrations and medical surveillance examinations." JournalofOccupational and Environmental Medicine, in press; Recent toxicological reviews funded by APFO Users and APME: 17)An assessment prepared for the AssociationofPlastics Manufacturers in Europe and SPI entitled "Genotoxicity, Carcinogenicity, Developmental Effects and Reproductive Effects of Perfluorooctanoate: A Perspective from Available Animal and Human Studies," December 19, 2002; and 18) Environmental Health Research Foundation, "Summary and Analysoifs Health Data on Periluorooctanoic Acid (PFOA)," March 5, 2003. LS Addendum 111 Manufacture ofAPFO Responsible manufacturing of APFO requires that the parties undertaking that manufacture meet certain environmental, health and safety standards. Accordingly, when manufacturing APFO for a commercial use in the United States, a responsible manufacturer will first notify EPA, and will review their product stewardship program with EPA covering the provisions listed below. For purposes of this addendum, manufacture means to make or produce for commercial use ata facility in the United States; importation of APFO for use in manufacturing or processing fluoropolymers is not included. 1). Limit total annual emissions in the US from each site where manufacturing of APFO occurs, using technology reasonably available that reduces APFO emissions to less than S00 pounds per year (a 99% reduction compared to prior `manufacturing technology as reported in the documents contained in EPA's docket); and 2) Sell or resell APFO in accordance with ACC or SOCMA good product stewardship codes; and 3) Offer voluntary blood testing for employees, conduct industrial hygiene `monitoring in the work areas where APFO is made or processed, and, based on the results, take steps to control the exposures 10 levels at least as low as the ACGIH TLV, by assuring that appropriate protective equipment and safe `handling practices are used, and continue to provide and update employee training on safe handling; and 4) Monitor groundwater and surface water for APFO in the vicinityof the facility, conduct air modeling studies based on available technology for air monitoring for APFO at the facility; maintain off-site exposure below the West Virginia screening levels; and 5) Beginning in the year after production commences, and continuing for five consecutive years following, for the prior calendar year, report to EPA biennially, ona calendar year basis (unless otherwise provided in individual agreements with EPA and state regulatory agencies), within 10 daysofthe endofthe reporting period, annual production volume of APFO, their emissions per facility (air, `water, waste), summary reports on groundwater and surface water monitoring results, workplace industrial hygiene monitoring, and summary data on employee blood monitoring results (taking steps to preserve employee confidentiality). 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