three different letters of intent (LOIs)

4 The Plastics Indtistry Ic I (Ic Associd lion Donald K. Duncan President March 14, 2003 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 Dear Mr. Johnson: On behalf of the Asahi Glass Fluoropolymers USA, Inc.; Daikin America, Inc.; Dyneon LLC; and E. I. du Pont de Nemours and Company, we are transmitting a Letter of Intent describing the initiatives that these companies have taken to assist EPA in its assessment of perfluorooctanoic acid and its salts. This Letter describes in some detail the activities underway to develop information and data needed to assure the continued safe use of ammonium perfluorooctanoate in the manufacture, processing, and use of fluoropolymers If you have any questions about the Letter of Intent, please contact Lynne R. Harris, of The Society of the Plastics Industry, Inc. (SPI) atRes ctfu 202-974-5233. fltm:, Don Duncan Enclosure cc: Charles M. Auer Margaret N. Schneider The Society of the P~astics lndus&y, tnc. 1801 K Street, NW, Suite 600K Washington, DC 20006-1 301 tel 202.974.5222 • fax 202.293.0309 dduncan@socpias.org http://www.plasticsindustry.org 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 ammonium perfluorooctanoate (APFO)’ to produce fluoropolymers and fluoroelastomers in the U.S. Fluoropolymers are plastic products while fluoroelastomers are rubber-like products, both of which provide highly desirable and unique properties that make the end-use products created from them useful. All of these companies are members of The Society of the Plastics Industry, Inc. (SPI) Fluoropolymers Manufacturers Group (FMG) and its Fluoropolymers Division (FPD). Together, they and/or their parent companies represent, both globally and in the U.S., most of known use of APFO for production of fluoropolymers. APFO is essential in making certain fluoropolymers,-2 which, in turn, are used in many high-performance applications in critical industries such as defense, aerospace, semiconductors, telecommunications, and pollution control. A list ofcommercial fluoropolymers is provided in Addendum Ito this document. Many grades of these fluoropolymers can be made only with APFO. The APFO Users share the goal of the U.S. Environmental Protection Agency (EPA) to understand and assess the toxicity of and exposures to the APFO usedby the fluoropolymer industry, and to safeguard human health and the environment. To that end, the APFO Users have made specific commitments to provide additional information and research to EPA. These The APFO Users use a commercially available form ofthe compound, technically known as octanoic acid, pentadecafluoro-, ammonium salt, CAS 3825-26-1. For purposes of this letter, we will use fluoropolymers to include fluoroelastomers, unless there is a distinction that needs to be made. The Honorable Stephen L. Johnson March 14, 2003 Page 2 of 15 commitments are: (1) to reduce emissions of APFO from fluoropolymer and APFO manufacturing facilities; (2) to conduct studies on both finished resins and finished products made from these resins to determine if any exposure to the general population can be related to the fluoropolymer industry; (3) to conduct studies on emissions from fluoropolymer processing facilities to determine the level of current emissions; and (4) to develop additional toxicological data on APFO. This Letter of Intent includes timetables for completion of various studies and research, including additional studies on the toxicity and environmental fate of the 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 II 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 benefits of fluoropolymers. 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 reexamine work practices in their own plants. Thus, the FMG prepared a global materials balance including APPO 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 fate ofthese 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 minimum of 50% 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 uses of the surfactants and the nature ofprocesses involved. The Honorable Stephen L. Johnson March 14,2003 Page 3 oflS 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.~ To facilitate the commitment to reduce emissions, du Pont has provided, and will continue to provide to FMG companies where needed, its “capture for destruction” technology, 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 applicability of available technologies to their processes and continue to track APFO emissions. Because of the differences in the manufacturing processes and the kinds of products manufactured, it is not possible to know whether these technologies will be effective, or if they are, what the final reductions will be. Nevertheless, the companies are committed to the minimum 50% reduction and to taking additional steps as describedbelow. The APFO Users, through the FMG, also continue to support research on the toxicology, ecotoxicology, and environmental fate of APFO, as suchresearch 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 process of determining any residual levels. The first step in this effort was to evaluate methods for analysis of APFO. The method evaluation work is under way, which is necessary to meet EPA’s QAJQC criteria and is difficult and time-consuming. As part of that effort, the FMG published in January 2003 Detecting and Quan4}5’ing 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. — The toxicologists and scientists who participated in the assessment included representatives from government, independent third party experts, and industry. The organizations represented included: West Virginia Department of Environmental Protection; Toxicology Excellence for Risk Assessment, Cincinnati, Ohio; U.S. Environmental Protection Agency, Region III; U.S. Agency for Toxic Substances and Disease Registry; EPA National office in Washington; and EPA’s Cincinnati Laboratory. The Honorable Stephen L. Johnson March 14, 2003 Page 4 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 those described by American Chemistry Council’s (ACC) or Synthetic Organic Chemical Manufacturers Assodiation’s (SOCMA) Responsible Care® programs in their efforts to support 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 AYFO, including the results oftoxicology studies, coordination efforts with EPA, and other activities, will be provided to processormembers of the 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 procedures of those who use dispersions and coatings made from dispersions on the safe handling of products that contain APFO. In addition, as part of their workplace product stewardship efforts described below, the APPO 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 suppliers of fluoropolymers, 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 assurethat 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 understanding of it 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 SPI FMG. Such information and studies may be conducted under the auspices of industry groups such as the Association of Plastics 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 environmental and health effects of APFO used in fluoropolymers. APFO Users are supportive of EPA’s efforts and intend to assure that EPA has adequate information to understand the benefits, and any risks, of APFO use in fluoropolymers. The Honorable Stephen L. Johnson March 14, 2003 Page 5 of 15 B. Data Quality APFO Users recognize the importance of assuring good data quality. EPA’s recently issued QAIQC Guidelines4 describe EPA’s efforts to maximize the quality of environmental information made available to the public in terms of quality, integrity, 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 I. Supporting EPA Efforts to Involve CDC in Testing Programs The APFO Users support adding APFO to the CDC N}IANES process. To facilitate that step, work is underway to confirm the validity of the 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 auspices of the APME, the following additional studies will be completed on the schedule noted: Study Description Acute toxicity in daphnia Acute toxicity in trout Algal growth Anticipated Report Date~ May 2003 May 2003 July 2003 Chronic toxicity in daphnia Chronic toxicity in trout Adsorptionldesorption soil studies ADE mass balance in rats Protein binding; rat/human June 2003 November 2003 June 2003 June 2003 August 2003 “Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency,” announced in 67 F.R. 63657, October 15, 2002. Quality Assurance for Data Collection; 5360.1/A2 May 2000. Based on commitments from contracting laboratories, we believe these dates can be met. EPA will be advised of any changes in the reporting schedule. The Honorable Stephen L. Johnson March 14, 2003 Page 6 of 15 Study Description Physiologically based kinetic modeling Mechanistic studies of pancreatic tumor induction in rats. Anticipated Report Dates October 2003 October 2003 Industry plans to conduct an additional study to determine parameters forroute-to-route extrapolation (oral to inhalation), and the protocol was discussed with EPA scientists. Timing for the anticipated report date will be communicated when the final bid for the project is accepted. Copies of the final reports for these studies will be submitted to EPA promptly upon receipt. EPA will be apprised immediately if any substantially new and unanticipated information develops as a result of the research programs consistent with current requirements; the above schedule does not, of course, supersede any statutory reporting obligations. Following EPA’s QA/QC guidelines, the reports will include documentation to allow EPA to evaluate the validity of 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 data quality guidelines. Through the FMG, the APFO Users will promptly submit final reports of these studies to EPA and consult with EPA on what additional studies would be beneficial. 3. Understanding Routes of Exposure Although there is no known evidence of adverse 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; (c) sites that use fluoropolymer dispersions containing APFO; and (d) articles of commerce containing fluoropolymers, including dry fluoropolymer products and dispersion coated products, that might lead to general population exposure related to the fluoropolymer industry. D. Specific Product Stewardship Activities by Site 1. Product Stewardship at Sites Where APFO Is Manufactured in the U.S. Consistent with the principles of Responsible Care®, any APFO User who decides to manufacture APFO for commercial use in the United States (including current manufacturers) will first notify EPA and will review its product stewardship program with EPA covering the provisions listed in Addendum III to this letter, which applies only to APFO manufacturing. As of the date of this letter, only one company has decided to manufacture APFO in the United States for use in fluoropolymer manufacturing. That company is du Pont, which already has committed to adopting the steps in Addendum III as part of its operating practices. Because The Honorable Stephen L. Johnson March 14, 2003 Page 7 of 15 of antitrust considerations, APFO Users are legally barred from seeking to enforce any kind of group sanction against a future U.S. manufacturer that does not adopt Addendum III as part of its operating practices. They also cannot take any steps that might be construed by the U.S. antitrust enforcement agencies as anti-competitive. However, EPA would appear to have adequate authority to assure that future U.S. manufacturers of APFO, if any, follow the provisions outlined in Addendum III and commit to adequate product stewardship. 2. Product Stewardship at Sites in the U.S. That Use APFO To Make Fluoropolymers As noted above, the APFO Users earlyon 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 minimum of 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 each ofthe 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 theirmanufacturing sites; development of the plans will begin not later than 30 days after the date of this letter; 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 2) Ouality Models (40 C.F.R. Part 51, Appendix W),0 and 3) assess the results using the air screening levels established in West Virginia; As necessary to implement a site-specific plan, conduct ground and surface water analysis, and assess the results using the water screening levels established in West 4) Virginia; and Use the West Virginia screening levels to determine what additional actions, if any, may need to be taken, after reviewing the information with EPA. These commitments will be undertaken at the following sites: http://www.epa.gov/scramo0 l/guidance/guide/ayyw 01 .pdf The Honorable Stephen L. Johnson March 14, 2003 Page 8 of 15 a) duPont Washington Works Plant Rt. 892 South Washington, WV 26181 b) Dyneon 1400 State Docks Road Decatur Alabama 3 5609-2206 c) Daikin 905 State Docks Road Decatur, AL 35601 Six months afler 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 days ofthis letter, provide a list of each 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 emissions of APFO at each site, on a calendar year basis. The reports will be submitted to EPA within 180 days of the end of each reporting period and will include CAS numbers for the substances reported; 3) For each listed site that uses APFO, continue to conduct industrial hygiene monitoring in the workplace of their 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 symptoms of overexposure and methods of proper handling, updating as new information becomes available, as part of their ongoing employee Occupational Safety and Health Administration Hazard Communication Standard programs. As further evidence of their ongoing commitment, the APFO Users will provide EPA with timely reports of their collective progress in reducing emissions and meeting the target goals so that the information can be made part of 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 h~dustrial Hygienists (ACGIIH) Threshold Limit Value (TLV) recommendations in assessing their occupational exposures to APFO, and they will continue to do so. As other recommendations become available, the APFO Users will incorporate them into theirprograms and, as they have in the past, work to ensure that their employees are adequately protected based on the best available 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 rationale of its monitoring programs going forward. 3. Product Stewardship at Sites in the U.S. That Use Fluoropolymer Dispersions Containing APFO The APFO Users are committed to continuing their Product Stewardship programs for their customers. To assist in assessing the potential routes of exposure at selected sites of their customers, the APFO Users, under the auspices ofthe 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 of APFO to the environment; 2) Submit the material balance to EPA and work cooperatively to identify and recommend appropriate product stewardship elements to control emissions at customer sites. 3) Target completion of the material balance by the end of 2003. This project is under way and the contractor is being selected. We expect that the results of the materials balance will suggest what actual monitoring maybe necessary. After the initial survey is complete, the companies will review the information to determine if further research or monitoring is required, and, if so, 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 which are discussed above, the APFO Users will continue to update information provided to customers and users of fluoropolymers, 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 The Honorable Stephen L. Johnson March 14, 2003 Page 10 of 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 either a dry resin form or as a liquid dispersion. It is the intent of the APFO Users that APFO not be carried through the manufacturing and processing of articles of commerce. To document that this is the case, the APFO Users, under the auspices of the FMG, will: 1) Analyze representative articles of commerce containing or made with dry fluoropolymer resins for the presence of APFO and report the results to EPA. 2) For products coated or manufactured with liquid dispersions, analyze representative articles of commerce for the presence of 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 articles of commerce. 4) Target completion of the analysis of articles of commerce by the end of2003. 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 sampling of industrial and commercial products. The articles of commerce 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 U.S. from fluoropolymers not supplied by APFO Users. Based on preliminary data obtained using preliminary methods, it is our expectation that articles of commerce made from dry fluoropolymers will have no significant amounts of APFO 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. The Honorable Stephen L. Johnson March 14, 2003 Page 11 of 15 * * * * * The APFO Users appreciate the opportunity to work with EPA on this matter and agree that close coordination ofour 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 withEPA. Respectfully Submitted, APFO Users, attached Attachments 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 III: Manufacture of APFO The Honorable StephenL. Johnson March 14, 2003 Page 12 of 15 Name: ‘Charles D. Allen Title: President Asahi Ola~s luoropolymers USA, inc, F The Honorable Stephen L. Johnson March 14,2003 ~a.ge13 o15 NameT~ ~ Title: FL~4t4 Daikin America, Inc. 7 _____ The Honorable Stephen L. Johnson March 14, 2003 Page 14 of 15 Nan~amesE. ~f D nLLC T~4resident 4~7 The Honorable Stephen L Johnson March 14, 2003 Page 15 oflS Name: Ric~J. Ang4o Title: ViccPresident ~‘Genera1Manager E. I. dii Pont de Nemours and Company Addendum I March 14, 2003 Page 1 of I Addendum I fiiii~opolymersand Fluoroelasfomers Which May Be Made With APFO Monomers Polymer family CAS Number FhuoropolynTlers ~TFE 9002-84-0 TFE FE!’ 25067-11-2 ft1F1~~ ~FA 26655-00-5 TFE, PPVE THV 25 190-89-0 TFE, HFP, VDF ~TFE 68258-85-5 TFE,.E___________________ THE 35560-16-8 TFE, HFP, E Pluoroelastomers Copolymers ferpolymers___________ tBase resistant elastomers 9011-i ~r9 VDF, HFP 25190-89~0t~FE,1iPP,‘VDF 54675-89-7, TTFE, VDF, ~ 27029-05-6 JTf~L__________________ Perfluoroelastomers 26425-79-6 J~~y_PVE CTFE elastomers 90 10-75-7 CTFE, VFD TFE, PMVE ~!~‘_temperature elastomers 26425-79-6 Acronym CTFE______ TFE HFP VDF PMVE PPVE P Monomers Used in Fluorop~y~rs Monomer name Chlorotrifluoroethylene Tetrafluoroethylene Hexafluoropropylene Vinylidene fluoride Periluoromethyl vinyl ether Perfluoropropyl vinyl ether Ethylene Propylene CAS Number 79-38-9 116-14-3 116-15-4 75-38-7 1187-93-5 1623-05-8 74-85-1 115-07-1 Addendum H Background and Voluntary Activities Background A. APFO Use in Fluoropolymers Ammonium perfluorooctanoate, orAPFO, 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 is essential in these processes. APFO typically is used in low concentrations (less than 1%) in the fluoropolymer manufacturing process and in a 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, it allows application of the dispersion, but it is not intended to be part of the fluoropolymer or the finished, end-use product. It is critical to understand the role of APFO in the fluoropolymer industry. The surfactant properties of AYFO facilitate the manufacture of fluoropolymers and fluoroelastomers, but it does not contribute to the performance of the end-use product. Therefore, it is not intended to be or needed in the end-use products made with it. — — In fact, most of the products made from fluoropolymers require heat treatment that removes or destroys the majority ofthe APFO in the fluoropolymer resin before the products made with fluoropolymers leave the manufacturing facility or are used. Therefore, fluoropolymer products do not normally present a route of exposure to APFO once-they--leave-the hands of 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 use of fluoropolymers. 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 use of fluoropolymers 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 behalf of The Society ofthe 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 existence of only one supplier, and the need formore 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. Addendum II Background and Voluntary Activities B. The Role of Fluoropolymers in Society March 14, 2003 Page 2 of 8 Fluoropolymers are essential to a variety oftechnologies 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 critical” applications that protect and benefit people and the environment. Fluoropolymers a~e 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 all these applications, fluoropolymers are the only materials that meet system performance needs in high temperatures and harsh chemical environments. C. 50 Years of Experience of Safe APFO Use APFO has been used safely and without apparent adverse effects on human health for more than 50 years, in part because of the workplace safety programs the APFO Users had in place. This conclusion is supported by epidemiology and other human health studies (contained in EPA’s 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 experience of 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 studies of the employees who have direct exposure showed any unusual or unexpected pattern of illnesses 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 out of the perfluorooctanyl chemistry used to produce certain repeflents and surfactant products.” Subsequent to the 3M announcement, EPA broadened their interest in a series of fluorochemicals that they considered to be persistent in the environment. This interest has been heightened recently by the discovery that certain of these fluorochemicals are found at trace levels in the blood ofthe US population. Addendum II Background and Voluntary Activities Voluntary Activities of APFO Users and Manufacturers March 14, 2003 Page 3 of 8 The users and manufacturers of APFO have, both individually and collectively, supported research into the potential effects on human health and the environment, 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 ofAPFO. 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 Association of Plastics 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 and a related chemical, perfluorooctanoic acid (PFOA).2 These studies are among those that 3M and du Pont have submitted to EPA. The number of research studies on APFO included in EPA’s docket is large. A brief list of some of the studies, including studies on human health assessments, is included in Appendix 1 of this Addendum. To coordinate their efforts to assess and respond to EPA’s concerns, the manufacturers of fluoropolymer resins, who are also members of SPI’s Fluoropolymers Division, formed the FMG. The mission of 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 fill in the gaps. The APFO Users, as members of 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 ofAPFO. APFO Users have reviewed EPA’s preliminary assessment of the 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 While APFO is the product used in fluoropolymers, PFOA is the substance that has been found in some, but not all, the environmental and blood samples that have been tested. PFOA is also the chemical that has usually been tested in animal studies, because APFO dissociates in water into PFOA and ammonium ions. EPA has I assigned OPPTS Docket Number AR226 for all submissions on perfluorinated substances. AR226 also contains documents pertaining to other perfluorinated chemical substances. The APFO Users believe that the matters concerning APFO are different from those associated with the other chemical substances included in EPA OPPTS Docket Number AR226. Addendum II March 14, 2003 Background and Voluntary Activities EPA with a number of new documents and information about the use of APFO in fluoropolymers. A. Fluoropolymer Manufacturers’ Product Stewardship Commitment Page 4 of 8 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 dissemination of 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 commitment of resources and efforts, and the activities described below are evidence ofthat commitment. B. Toxicology Research A number of the toxicology studies relevant to APFO that have been submitted to EPA, some of which were conducted in the early 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 Group of the 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 studies of effects 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 matter of good industrial hygiene practice, the APFO Users have occupational health and safety programs to 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 use of protective clothing, gloves, face shields, and respirators, disposable garments, installation of general mechanical and local exhaust ventilation systems, and other handling practices as recommended in the manufacturer’s MSDS. These precautions, the effects of Addendum II Background and Voluntary Activities March 14, 2003 Page 5 of 8 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 Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) of an eight-hour time-weighted-average (TWA) of 0.01 milligram per cubic meter (mg/rn3). 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 those of the 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 transmittal of appropriate information to downstream users. If improper practices involving a product 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 AFFO 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 handling of their 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 creation of a Guide to the Safe Handling of Fluoropolymer 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 effects of some byproducts also were included. The Chapter on Safety Measures has extensive discussions of steps 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 Addendum II Background and Voluntary Activities March 14, 2003 Page 6 of 8 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 Handling of 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 it is available. Addendum II Background and Voluntary Activities Appendix 1 Partial List of Studies on APFO in EPA’s Docket Studies funded by APFO Users and manufacturers: March 14, 2003 Page 7 of 8 1) Fayerweather, “Liver Study of Washington Works Employees Exposed to CS: Results of Blood Biochemistry Testing,” January 15, 1981; 2) Gortner, E.G. (1981). “Oral Teratology Study of T-2998CoC in Rats.” Safety Evaluation Laboratory and Riker Laboratories, Inc. Experiment No. 0681 TRO 110, December 1981; 3) Gortner, E.G. (1982). “Oral Teratology Study ofT-3l4lCoC in Rabbits.” Safety Evaluation Laboratory and Riker Laboratories, Inc. Experiment No. 068 1TB0398, February 1982; 4) Biker (1983). “Two-Year Oral (Diet) Toxicity/carcinogenicity Study of Fluorochemical FC-l43 in Rats.” Riker Laboratories, Inc., ExperimentNo. 0281CR0012, May 1983; 5) Staples, R.E., Burgess, B.A., and Kerns, 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, R.G. (2002). “Oral (Gavage) Two-generation (One Litter per Generation) Reproduction Study of Ammonium 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 of Minnesota; 8) Gilliland, F.D. and Mandel, J.S. (1993). “Mortality among employees of a 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 study of occupationally 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, J.S. and Mandel, J.H. (1998). “An epidemiologic investigation ofreproductive hormones in men with occupational exposure to perfluorooctanoic acid.” Journal of Occupational and Environmental Medicine, vol. 40, pp. 614-622; 11) Olsen, G.W., Burr, J.M., Burlew, M.M., and Mandel, J.H. (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. (2001 a). “Mortality Study of Workers Employed at the 3M Cottage Grove Facility.” Minneapolis (MN), University of Minnesota; 13) Alexander, B.H. (2001b). “Mortality Study of Workers Employed at the 3M Decatur Facility.” Minneapolis (MN), University ofMinnesota; Addendum II Background and Voluntary Activities March 14,2003 Page 8 of 8 14) Olsen, G.W., Logan, P.W., Simpson, C.A., Burris J.M., Burlew, M.M., Lundberg, J.K., and Mandel, J.H. (2001a). “Descriptive Summary of Serum Fluorochemical Levels among Employee Participants of the 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., Burns J.M., 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-226-1030a02; 16) Olsen, G.W., Burns, J.M., Burlew, M.M., and Mandel, J.H. (2003). “Epidemiologic assessment of worker serum perfluorooctanesulfonate (PFOS) and perfluorooctanoic acid (PFOA) concentrations and medical surveillance examinations.” Journal of Occupational and Environmental Medicine, in press; Recent toxicological reviews funded by APFO Users and APME: 17) An assessment prepared forthe Association of Plastics 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 Analysis ofHealth Data on Perfluorooctanoic Acid (PFOA),” March 5, 2003. Addendum III Manufacture ofAFFO Responsible manufabtuning 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 at a 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 500 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 to 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 vicinity of the facility, conduct air modeling studies based on available technology for air monitoringfbr 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, on a calendar year basis (unless otherwise provided in individual agreements with EPA and state regulatory agencies), within 180 days of the end of the reporting period, annual production volume ofAPFO, 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). Page 1 of 1 March 14. 2003 3M General Offices 3M Center St. Paul, MN 551444000 651 733 1110 31V1 March 13, 2003 Stephen L. Johnson Assistant Administrator Office Of Prevention, Pesticides And Toxic Substances United States Environmental Protection Agency 1200 Pennsylvania Avenue, N. W. Washington, D. C. 20004 Re: Environmental, Health And Safety Measures Relating To Pertluorooctanoic Acid And Its Salts (PFOA) Dear Assistant Administrator Johnson: 3M Company (3M) understands that your office has been evaluating perfluorooctanoic acid and its salts (‘PFOA”), which are perfluorinated, 8 carbon carboxylate surfactants used primarily as fluorinated polymerization aids (FPAs) in the manufacture of fluoropolymers.’ This letter confirms 3M’s intent to continue ongoing environmental, health and safety (EHS) measures relating to PFOA. In particular, this letter documents past EHS measures by 3M to characterize exposure to PFOA; to conduct health and environmental fate and effects research for PFOA; and to reduce PFOA exposure through a production phase-out and other measures. This letter also summarizes 3M’s plans for ongoing and future EHS measures to develop additional data characterizing exposure to PFOA; to continue to monitor possible PFOA presence in the environment near 3M’s former manufacturing facilities; to characterize possible PFOA exposure pathways from 3M’s former manufacturing and commercial activities; and to fund additional health and environmental fate and effects research for PFOA. I. PERTINENT BACKGROUND 3M production records reflect that PFOA was produced at various facilities from 1969 to 2002 using electrochemical fluorination (ECF) technology. Between 1992 and 2002, 3M’s total PFOA production averaged 250,000 pounds per year. Chemical Name: Perfluorooctanoic Acid (FFOA). Molecular formula: C3 H F15 02. CAS Number: Various, including: 335-67-1 (free acid); 3825-26-1 (ammonium salt); 335-95-5 (sodium salt); and 2395-00-8 (potassium salt). The perfluorooctanoate anion has no specific cAS number. Stephen L. Johnson March 23, 2003 Page 2 Approximately 97 percent of the PFOA produced by 3M was used by its industrial customers and in its own processes as a fluoropolymer processing aid. The remaining 3 percent totaled roughly 8,000 pounds per year and was used in a medical film coating application and in electronics applications involving printed circuit boards and precision bearings. Between 1998 and 2002, 3M submitted to EPA serum analyses of the U.S. population and certain U.S. population subgroups. These analyses indicated the presence in individual and pooled human serum samples of the PFOA anion at very low mean levels of 4-6 parts per billion (ppb). Wildlife sampling also occurred during this period and indicated the presence of the PFOA anion only in limited circumstances. Toxicological and epidemiology studies on PFOA have been sponsored by 3M as well as other members of industry addressing a range of health end-points. These studies are available to the public along with other information through a public docket maintained by EPA OPPTS AR-226. -- 3M does not believe that the PFOA levels measured in workers, the U.S. population or the environment cause adverse effects in humans, but is acting on a voluntary basis to develop additional PFOA health and environmental fate and effects data; to provide additional characterization of potential PFOA routes of exposure; and to agree to undertake additional measures to reduce or prevent PFOA exposure whenever practicable. The details ofthese EHS commitments by 3M are described in Section II. below. II. EHS COMMITMENTS BY 3M A. Past 3M EHS Measures For PFOA Over the years, 3M has undertaken a wide range of measures to assess the exposure and toxicological profile of PFOA. The elements below describe 3M’s major past actions, but are not an exhaustive list of 3M’s past EHS measures. 1. 3M has monitored the health of fluorochemical production workers dating back to 1978. More recently, this monitoring program has involved periodically measuring PFOA levels in serum, tracking clinical chemistries and communicating with workers regarding these results; undertaking industrial hygiene measures to monitor and reduce workplace exposures; and conducting medical surveillance, epidemiological and other forms of pertinent study. 2. 3M has both engaged in and supported toxicological research to address whether PFOA has the potential to cause any health effects for a range of endpoints, including developmental toxicity, mutagenicity, chronic toxicity, reproductive effects and cancer. These data are available to the public, along with other information, through the EPA-maintained OPPTS AR-226 docket. Stephen L. Johnson Merch 13,2003 Page 3 3. 3M has performed extensive analytical work to determine PFOA exposure levels in the U.S. population and the environment. For this work, 3M engaged in state-of-the art methods development and refinement to lower limits of detection and quantification. 3M also qualified independent laboratories to apply these methods. Analyses were performed of pooled blood samples from U.S. blood banks as well as of individual blood samples from various population subgroups. A study also examined liver tissue. With respect to environmental monitoring, 3M conducted monitoring in the vicinity of its now former PFOA production facilities; analyzed serum and liver samples from fish, birds and other wildlife for the presence of PFOA; and sponsored a Multi-City Study in which a variety of environmental compartments were analyzed. These data also are available to the public through the OPPTS AR-226 docket. 4. Over the years, 3M also has undertaken steps to limit PFOA exposures in the workplace. These steps have included implementation of industrial hygiene controls at 3M fluorochemical production facilities, including adoption of exposure guidelines. 3M also has taken various actions to reduce environmental releases of PFOA at these facilities, including capture and incineration of PFOAcontaining waste streams and the implementation in 1998 of activated carbon systems to improve the removal of PFOA from wastewaters. 5. In 1997, 3M obtained new analytical data on PFOA and periluorooctane sulfonate (PFOS) serum levels in the general population and promptly shared these data with EPA. Thereafter, 3M shared additional data and exposure information with EPA on perfluorooctanyl chemicals, including PFOA, and cooperated with EPA in evaluating hazard and exposure issues associated with these chemicals. 6. Subsequent to obtaining the new analytical data on PFOA and PFOS serum levels in the general population, 3M decided to phase-out its perIluorooctanyl chemistry substantially by the end of 2000. This phase-out included terminatin9 all PFOA production for commercial sale by the end of 2002. 3M’s Dyneon subsidiary2 continues to manufacture small quantities of PFOA at its facility in Gendorf, Germany for its own internal use as a fluoropolymer manufacturing aid at its two facilities. In this connection, Dyneon has made process changes that reduce the quantity of PFOA required and has developed a “capture for recycle” technology that reduces the need for new PFOA. As described in Section Il.C.6. below, Dyneon will be engaging in its own EHS measures in connection with this limited production and use, including further reduction of PFOA use. 2 Dyneon engages in the manufacture of fluoropolymers and fluoroelastomers and operatestwo facilities one in the United States and one in Germany. Formerly a joint venture between 3M and Hoechst AG, Dyneon now is a wholly-owned subsidiary of 3M. -- Stephen L. Johnson March 13, 2003 Page 4 B. Characterization Of Other Potential Routes Of Exposure A qualitative discussion more fully characterizing possible exposure routes related to non-fluoropolymer PFOA uses and discontinued perfluorooctanesulfonyl fluoride (POSF)-based products follows below. This discussion reflects two key points: (i) 3M’s commercial PFOA production for non-fluoropolymer uses occurred on a limited basis at a level of only 8000 pounds per year for medical film and electronics applications with low exposure potential; and (ii) POSF-based products did not likely pcov~de route of measurab~e a PFOA exposure. 1. Production Of PFOA For Non-Fluoropolvmer Uses -- 3M produced limited quantities of PFOA approximately 8,000 pounds per year in recent years for non-fluoropolymer uses. The principal non-fluoropolymer use occurred in a medical film application where PFOA served as an antistatic additive in coatings sandwiched between multi-layer medical films. No consumer or medical patient exposure would be expected from this application. Worker exposure should have been minimal given that the PFOA sold for this application in recent years was in a 30 percent aqueous solution and the MSDS advised protective measures during handling and use. -- A small amount of PFOA less than 500 pounds per year-- was derivatized as an ester to form a methacrylate co-polymer coating used in electronics applications to provide a humidity barrier on printed circuit boards and to secure silicone oil on precision bearings, for example, in gyroscopes and telecommunications switching stations. These applications involved PFOA derivatized into a stable polymer, making PFOA exposure to workers, the consumer or the environment highly unlikely. -- 2. Transformation Of POSF-Based Substances 3M has submitted two biodegradation studies to EPA on N-Et FOSE 3 N-Et FOSE alcohol was both a building block intermediate used in the alcohol. production of many POSF-based products and one of the prevalent fluorochemical residuals found in POSF-based products. The biodegredation studies were performed in accordance with EPA OPPTS Guidelines at 40 C.F.R. 835.3200—3210 & -5045. Both studies indicate that PFOS would be generated through the biotic degradation of N-Et-FOSE alcohol, but that PFOA could be formed instead of PFOS only under an abiotic or hydrolytic condition during the last step of the degradation pathway. The diagram below depicts the degradation pathway indicated by these studies. 3M E01-0415 dated February 23, 2001; 3M E0O-2252 dated October 1,2000, available in OPPTS AR-226 docket. Stephen L. Johnson March 13, 2003 Page 5 N-Et FOSE Alcohol Biodegradation Pathway N-ETFOSE ALCOHOL (STARTING SUBSTANCE) + + 4 N-ETFOSE ALDEHYDE N-ETFOSAA N-ETFOSA N-(2) HYDROXYETHYL PERFLU ROOCTANE SULFONAMIDE PERFLUOR000TANE SULFONAMIDE ACETALDEHYDE M556 FOSA PFOSulfinate Biotic Mechanism 4 4 + 4 PFOS / Only Under \~iot1c Conditions PFOA Stephen L. Johnson March 13, 2003 Page 6 As the diagram depicts, these studies indicate that under biotic conditions, the N-Et FOSE alcohol will follow a stepwise degradation pathway that results in PFOS as the ultimate degradation product. Prior to the final degradation step to PFOS, the penultimate intermediate degradation step involves degradation to a compound known as periluorooctane sulfinate. The protocol for these studies requires a degradation control test to be run under abiotic conditions for each step in the pathway. In this control test, the perfluorooctane sulfinate did show some degradation to PFOA. My such degradation to PFOA, however, did not occur under biotic conditions, but instead only in the abiotic control test mode and only during the last step. Several factors indicate that PFOA is not the expected biological degradation end-product of the other fluorochemical residuals present in POSF-based products. First, while some degree of abiotic degradation can occur in a biotic system, the particular biodegradation pathway described above suggests that PFOS formation would be the expected degradation route. Hence, even if the other fluorochemical residuals present in POSF-based products were absorbed by humans or wildlife, PFOA is unlikely to be formed as a metabolite. Second, to the extent PFOA could be formed in an abiotic environmental compartment, no PFOA uptake from that compartment would be expected because, as studies have shown, PFOA does not bioconcentrate.4 Third, in the highly specialized and limited circumstances where PFOA could form and transfer from an abiotic environmental compartment to water, the PFOA should be immediately diluted due to its water solubility (>100,000 mg/L or 10 percent by weight for ammoniurn perfluorooctanoate),5 and hence, should remain present in the water, if at all, at miniscule levels. Finally, although studies have been done only on the N-Et FOSE alcohol, this degradation pathway should be representative of the other major building blocks for POSF-based products.6 3. PFOA As An Impurity In POSF-Based Products 3M analytical studies of eight POSF-based product samples have identified the presence of PFOA at very low concentrations ranging from 200-1600 ppm as a manufacturing impurity. Based on 1997 production information, the estimated See Kurume Laboratory, 2001. Bioaccumulation Test of Perfluoroalkylcarboxylic acid (c=7-1 3), Test No. 51519., chemicals Evaluation and Research Institute, Japan (Dec. 18, 2001), at 1-26 (the carp exposed to 5 * gIL resulted in a BCF of 3.1, while carp exposed to 50 * gIL showed a BCF of <5.1-9.1); see also Revised Draft Hazard Assessment Of Perfluorooctanoic Acid And Its Salts, U.S. EPA (Nov. 4,2002), at 1, 14. See characterization Study of PFOA (Lot #332) Primary Standard Test control Reference # TCR-99030-030 Phase: Solubility Determination, available in OPPTS Docket AR-226. The N-Et FOSE alcohol served as the key building block for the vast majority of 3M’s POSFbased products. The other key alcohol building block, N-Me FOSE alcohol, would be expected to have a comparable degradation pathway due to its structural similarity to the N-Et FOSEalcohol. Moreover, N-Et FOSE alcohol was a precursor to the other key building block compounds for 3M’s POSF-based products, and hence, degradation pathways for these building blocks already are captured by the N-Et FOSE alcohol degradation studies. — 6 Stephen L. Johnson March 13,2003 page 1 annual levels of PFOA residual present in POSF-based products would not have exceeded 6000 pounds. Nearly 95 percent of POSF-based products and hence nearly all of the 6000 annual pounds of PFOA residual present in such products were commercialized into industrial applications.7 A number of these applications involved use of high molecular weight polymers or other formulated POSF-based products for surface treatment of carpets and fabrics or for coating on paper and packaging. Due to the nature of these applications, only a minute amount of the PFOA residual, at most, would have ended up in the finished article. Moreover, a number of the industrial applications br POSF-based products involved the use of aqueous washing or finishing steps. In view of PFOA’s water solubility, a washing or finishing step most likely removed the very small amount of PFOA residual present in such product. Any industrial release of PFOA residual into the environment from these sources would likely have resulted in extremely low concentrations in localized aquatic systems and would not have provided a source of measurable PFOA exposure. -— C. Future EElS Measures In addition to the PFOA production phase-out and the numerous other measures undertaken to date as detailed above, 3M plans to engage in ongoing and future EHS measures itemized below. 3M plans to undertake these measures in an expeditious manner and may undertake additional EHS measures not described in this letter, as warranted, under 3M’s existing safety, health and environmental programs. 1. 3M will not resume the manufacture of PFOP.. for comiwerdat sale. 2. 3M will continue with its medical monitoring efforts for fluorochemical production workers and will provide reports to EPA on a bi-annual basis on the results of this program. These efforts will continue to include monitoring for the presence of PFOA. In addition, 3M will continue to track the mortality experience of the fluorochemical production worker cohort and will submit updated epidemiologicâl study reports to EPA every five years. 3M will continue to monitor in the vicinity of its former PFOA production facilities. This monitoring will include groundwater, surface water and other environmental media and will be part of ongoing requirements and/or voluntary commitments established with local regulatory agencies. 3M will provide an initial summary report to EPA for this monitoring within two years of the date ofthis letter and periodic additional reports at appropriate intervals thereafter. 3. 4. 3M will work with other members of industry to conduct additional validation of the PFOA serum analytical method and sampling protocol; publish the analytical method in a peer reviewed journal; and continue to qualify independent See Fluorochemical Use, Distribution Arid Release Overview (May 26, 1999), available in OPPTS Docket AR-226. Stephen L. Johnson March 13, 2003 Page 8 laboratories to perform the validated method. 3M will support the efforts of the Centers For Disease Control (CDC) and EPA to develop a more complete understanding of the PFOA levels present in the general population and the environment. 3M will continue to assess the appropriateness of undertaking additional research and other actions in coordination with CDC and EPA. 5. 3M will participate in certain human health and environmental fate and effects studies of PFOA. These studies will occur under the auspices of the Association of Plastics Manufacturers of Europe (APME) and will include the following: (i) chronic toxicity in daphnia; (ii) chronic toxicity in trout; (iii) ADE mass balance in rats; (iv) protein binding rat/human; (v) physiologically based kinetic modeling; (vi) adsorption/desorption studies; (vii) acute toxicity in daphnia; (viii) acute toxicity in trout; (ix) algal growth; and (x) mechanistic studies of pancreatic tumor induction in rats. The results of these studies, and any additional studies, will be promptly communicated to EPA in the form of final reports. The industry participants will consult with EPA on what additional studies would be beneficial. -- 6. As discussed above, Dyneon will continue to produce small amounts of PFOA for internal use and will continue to use PFOA in fluoropolymer production. In connection with this production and use, Dyneon will engage in various EHS measures, including: a. Dyneon will continue to reduce further the now small use at its facility in the United States of PFOA imported from Dyneon’s Gendorf, Germany facility. b. Dyneon has developed and is using a “capture for recycle’ technology for PFOA and has made that technology available for license by other PFOA users. This technology, which allows for a recapture and reuse of PFOA, has and will continue to result in a significant reduction of PFOA emissions and production demands for Dyneon. c. Dyneon’s employees in the United States will continue to be part of the 3M program for medical monitoring of fluorochemical production workers and will be included in the above-referenced reports to be submitted by 3M on the results of this program. This program will continue to include monitoring for the presence of PFOA. Dyneon’s employees at the Gendorf, Germany facility have been and will continue to be subject to an equivalent program that follows 3M’s monitoring protocols. d. Dyneon’s fluoropolymer manufacturing facility in the United States will continue to be part of the above-referenced 3M environmental monitoring program. This monitoring will include groundwater, surface water and other environmental media and will be part of ongoing requirements and/or voluntary commitments established with local regulatory agencies. Periodic reporting of the results of this monitoring program will begin within two years from the date of this letter and occur at appropriate intervals thereafter. Stephen L. Johnson March 13, 2003 Page 9 e. Dyneon will commit, as a signatory to the separate letter of intent among PFOA users in the fluoropolymer industry, to perform the exposure assessment and testing specified therein. In connection with the foregoing EHS measures, 3M recognizes the importance of EPA’s recently-issued guidelines pursuant to the Data Quality Act.8 We will continue as we have in the past to employ scientific practices, protocols and procedures designed to ensure that data meeting reasonably appropriatwbenctimarksfor objectivity, utility and integrity are developed and provided to the Agency. --- * * * 3M appreciates this opportunity to memorialize our prior, ongoing and future EHS measures for PFOA. We look forward tp dialogue with EPA regarding the content of this letter. Very truly yours, Dr. Larry Wbndling Vice President Performance Materials Division 3M Company cc: Charles Auer, Director Office Of Pollution Prevention And Toxics DC\571981.4 See Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency; Public Law 106.554itR. 5658, § 515(a) (2001); Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 0MB, 67 Fed. Reg. 8452•f2-002);--sse also EPA Order 5360.1A2 ‘Policy And Program Requirements For Agency-Wide Quality System” (May 5, 2000); EPA Quality Manual For Environmental Programs, 5360A1 (May 5, 2000). March 3~, 003 2 Regular Mail The Honorable Stephen L. Johnson Assistant Administrator United States Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 1200 Pennsylvania Avenue N.W. (Room 7101M) Washington, DC 20460 Dear Mr. Johnson: This letter reaffirms the commitment of the companies identified below to assist the Environmental Protection Agency (EPA) in its investigation of pcrfluorooctanoie acid(PEOA) and ammonium perfluorooctanoate (APFO).1 1) APFO Users: Asahi Glass Fluoropolymers USA, Inc., Daikin America, inc.. Dyneon, LLC, and El. du Pont de Nemours and Company. These companies use AFFO as a polymerization aid to manufacture fluoropolymers and fluoroelastorners. DuPont aso manufactures APFO in the United States for use in Iluoropolymer manufacturing. 2) Telomer Companies: AGA Chemicals, Inc.. Clariant GmbH, Daikin America, Inc., and E.I. du Pont de Nemours and Company. These companies produce or import fluorotelomerbased products, which are used as fluorosurfactants and surfacc protection chemicals. 3) The 3M Company, the former U.S. manufacturer of AFFO. All signatories share and support the goals ofsafeguarding human health and the environment. By means of this letter and separate Letters of Intent, the signatories affirm their commitment to work on a comprehensive program to develop additional data on potentiaflicalth or environmental effects of PFOA, to better characterize exposure pathways, to reduce or prevent such exposure, and to examine and, as necessary, strengthen product stewardship and ristc communication practices. While the APFO Users utilize APFO as a polymerization aid to manufacture cen~ntluoropolymcrs and fluoroelastomers, PFOA is the substance that has been found in some, but not all, the environmental and blood samples that have been tested. PFOA is also the chemical that has usually been tested in animal studies, because APFO dissociates in water into PFOA and ammonia. EPA has assigned Docket Number AR.226 for all submissions on periluorinated substances. AR226 also contains documents pertaining to other periluorinated chemical substances. The APFO Users believe that the matters concerning APFO are different from those associated with the other chemicai substances included in EPA Docket Number AR226. Mr. Stephen L. Johnson March 31, 2003 Page2 of 10 The APFO Users are committed to reducing emissions of APFO from fluoropolymer manufacturing facilitics. The APFO Users have committed to developing information to support a better understanding of exposure to APFO through conducting studies on finished resins and finished products, and on emissions and discharges from fluoropolymer processing facilities. They are also committed to further studies of the toxicology of APFO. Through the Society of the Plastics Industry (SPI), the APFO Users will submit information on work with EPA as this process moves forward. SPI is signing this agreement only to signify its willingness to act as a facilitator and conduit for information and communications between EPA and the fluoropolymer manufacturers and other members of the fluoropolymer industry, including fluoropolymer processors. Its participation is not an indication that SPI has any obligations addressed by separate agreements or Letters of Intent submitted by the APFO Users, the Telomer Companies, or 3M. The Telomer Companies do not use PFOA or APFO in their manufacturing processes. These companies have committed to investigating whether and how telomer products can transform or break down into PFOA, and if so, to support a better understanding of those processes. The 3M Company has I) provided a summary of previous activity taken by the company including the phase-out of the production for sale of PFOA at the end of 2002, and 2) committed to a plan to continue a monitoring program for its former manufacturing sites. The APFO Users, the Telomer Companies and 3M will each keep the EPA apprised of progress in conducting the research under their respective Letters of Intent. They will provide status reports to EPA and individually share the results from all studies, surveys or other investigations, as specified in the Letters of Intent. The signatories of this letter appreciate the opportunity to work with EPA on this matter and agree that close coordination of our efforts and sharing ofinformation is important. Accorthngly, we will continue to communicate with EPA as information becomes available. Respectfully Submitted, APFO Users Telomcr Companies The 3M Company Mr. Stephen L. Johnson March 31, 2003 Page 3 of 10 Name ,~l’A’)’/) ~ Title: V/~~ s,~Jr The 3M Company Mr. Stephen L. Johnson March31, 2003 Page 4 of 10 aine Title: ç~ Cc~~~Q AGA Chemicals,lnc 6~2~ c~ Mr. Stephen I Johnson March 31, 2003 ~ag~.5 oE 10 ~. Charh~s . Allen U PiesI den I. Asahi (‘ilass .t”tuoropolyme.rs USA, Inc. Mr. Stephen L. Johnson March 31, 2003 Page 6 of 10 // 2 . b. ~-H . Name —~ Title: .Uc~~flc~L~ rc~_Lc~~ cL.xj ClariantGmbH tie c,~cL~c ~ ~Q (77 2.e;~ AQr’c?/ ICi !/Lj Mr. Stephen L. Johnson March 31,2003 Page 7 of 10 7 Name Title: Daikin America, Inc. ~ T4~4F~1~O ~A~A,kJCc,f~ Mr. Stephen L. Johnson March31, 2003 PageS of 10 Naii~arnesE~~ Titi resident Dyneon LLC Mr. StepJien L.. Johnsoi~ i~b 2003 31, Page 9 of 10 Name Rie~~dJ. 4ullo Tit1e~ vi6e President 6~ Gene~a1I~1anage~ E. L thi. Pop~ Nemours and Company d~ Mr. Stephen L. Johnson March 31, 2003 Page 10 of 10 Name P.ti DVPQc4#) Title: Pp’e ctc3 4J— The Society of the Plastics Industry, Inc. March 14, 2003 Mr. Stephen L. Johnson Assistant Administrator for Prevention, Pesticides and Toxic Substances US Environmental Protection Agency (7101M) 1200 Pennsylvania Avenue NW Washington, DC 20460 Re: Letter ofIntent for the Telomer Research Program Dear Mr. Johnson: The parties to this letter, as members of the Telomer Research Program (TRP)1 which comprise the major telomer producers, have prepared this Letter ofIntent (LOl) to address questions raised by the US Environmental Protection Agency (EPA) about the possible association of perfluorooctanoic acid (PFOA) with telomer-based products. The purpose of this letter is to affirm our commitment to responding to the concerns ofthe EPA and to provide a summary of (i) the actions the parties are pursuing in 2003, (ii) additional product stewardship measures that the TRP members will implement, (iii) information that the TRP will provide the EPA, and (iv) work conducted to date. The TRP is evaluating telomer products sold in the United States to determine whether they contribute to significant human or environmental exposure to PFOA. Our evaluation has six key components. 1. 2. 3. 4. 5. 6. Analysis of products and articles Analysis of “aged” products and “in use” articles Characterization ofpotential release of PFOA from telomer-based product manufacture Characterization ofpotential release of PFOA from telomer-treated article manufacture Analysis of possible biodegradation of telomer-based polymeric products Evaluation of the ultimate fate and disposal routes for telomer-treated articles in the United States EPA has expressed a concern to our industry about reports oflow but widespread levels of PFOA in human blood. We recognize that, although there is no evidence of a health effect at the levels found, the presence of PFOA in blood is a concern for EPA. Telomers are not made from PFOA, nor is PPOA added during the manufacture or use oftelomer products. Questions have arisen about the potential for telomers to transform to PFOA under various conditions. We believe the potential for such transformation is small, any PFOA levels that may result from this potential conversion would be small, and the overall contribution oftelomer products to human exposure to PFOA consequently would be negligible. However, the TRP members commit to ‘The companies participating in the TRP include Asahi Glass, Clariant GmbIl, Daikin Industries and E.I. duPont de Nemours & Company. Mr. Stephen L. Johnson March 14, 2003 Page 2 verifying that these assumptions are true and have set forth below a program of research to meet this responsibility. Fluorotelomers are used in a number of specialized products including: water and oil repellents and barriers for carpets, clothing, upholstery, and paper; mold releases forplastic and rubber molding; aqueous film forming foams (AFFF firefighting agents); and wetting agents for floor polish, inks and a range of similar applications. There is only one TRP member company (DuPont) that manufactures both the basic telomer chemicals and end-use products in the United States. One additional TRP member (Daikin) is a manufacturer who imports the basic telomer chemicals and processes them into end-use products in the United States. The other TRP companies (Asahi Glass and Clamant) are importing end-use telomer products to the United States. Approximately 90% of the volume of telomer products goes to industrial users, who apply them to carpets, textiles and paper at the mill sites, coat them on various surfaces (e.g., molding machines), or mix them into polishes, inks and other products. As supplied to those industrial users, telomer-based products may contain PFOA as an impurity in trace amounts. Given the known worldwide production of telomers, the levels of PFOA that would be placed in commerce per year, based on this understanding, is expected to be relatively small. We are not sure how that amount ofPFOA is formed, but this information may suggest that there is some potential for telomers to transform to PFOA. We are now trying to determine whether there are relevant routes by which telomers may, in fact, transform to PFOA and to what degree these transformations take place. An important element of this LOl is our evaluation of this question. Investigating the amount of PFOA from telomer products is made more challengingby direct inputs of PFOA from other sources into the environment and by environmental loadings from legacies attributable to widespread use ofdiscontinued surfactants and oil- and waterrepellent chemistries. In all of the projects described in the commitment section of this LOT, the TRP members intend to deliver data that will meet EPA’s guidelines forinformation quality.2 Even where we are conducting relatively short-term screening analyses, we intend to meet appropriate EPA standards. Our commitment to data quality will not compromise our efforts to supply the -EPA with information in an expeditious manner. The TRP is committed to conducting a proactive program to develop additional data on environmental fate of our products, better characterize routes ofexposure, strengthenproduct stewardship and risk communication practices, and take additional measures to reduce or prevent exposure wherever new data suggest that such changes are needed. 2 EPA has issued Information Quality Guidelines, in conformance with the Data Quality Act and guidance issued by the Office of Management and Budget. TRP also will consider EPA Order #5360.1 I 82 (Quality System) for further guidance on how to document QAIQC measures. Mr. Stephen L. Johnson March 14, 2003 Page 3 TRP Voluntary Commitment The members of the TRP are working together to complete the assessments described below related to telomer products. TRP will provide periodic briefings to EPA staff to summarize recent results from these telomer-related studies. These briefings are expected to occur at least monthly in 2003. In addition, the TRP will provide new documents, other materials and final study reports to EPA as soon as they become available. 1. Product and Article Analysis The TRP has contracted with an outside research laboratory to analyze for the presence of PFOA in the major end-use telomer products in commerce and articles treated with those products. TRP will provide EPA with a description of the scope and rationale for analysis of PFOA in telomer-based polymeric products and telomer-treated articles during March 2003. TRP analytical experts have developed the appropriate sampling and analysis-plans-as well as analytical standards for the work. Draft plans for the “Product and Article Analysis” study and “Sampling Guidance” were provided to the EPA on February 14, 2003 for review and comment. The screening study will begin in March 2003; the final report is expected by June / July 2003. The results will be provided to EPA as soon as they are available. This analysis will address three major use categories: carpets, textiles and paper. The primary products that our members market for these applications are polymer&(approximately 85% ofwhat the TRP members manufacture and sell). The products to be tested are those that the respective TRP member companies manufacture as actual items of commerce. While there are many potential telomer polymeric products, a relatively small number represent the primary product classes in commerce (12 products). As a result, the TRP will provide EPA with a comprehensive initial picture of exposure potential by focusing on these major end-use polymers and the corresponding articles of commerce. The treated articles to be tested are actual carpet, textile, and paper substrates treated under representative mill conditions with the subject telomerbased polymeric products. The chemical identities of these particular polymers, volumes, and their relative market share, are Confidential Business Information (CBI). The TRP members intend to provide the Agency with specifics about each polymer to be tested, such as its structure, CAS number,~ chemical name, 2002 use and volume in commerce, through company-specific submissions. This information will be supplied to the EPA by March 24, 2003. TRP companies will also provide EPA (under CBI) specifics such as structures, CAS numbers, chemical names, 2002 uses and volumes in commerce of all other telomer products used in the United States (including nonpolymeric products) by May 2003. 2. Analysis of “Aged” Products and “In Use” Articles The TRP members will examine transformation of end-use telomer products for potential PFOA generation that might occur through storage ofthe product over time or through normal use of treated articles. TRP will develop a plan by April 2003for conducting PFOA “aging” and “in use” analyses ofthe specific products and treated articles that are the subject oftheTRPsponsored work in Item 1 above. For these analyses, “aged” means the likely conditions our Mr. Stephen L. Johnson March 14, 2003 Page 4 products will see under normal storage and distribution. “Tn-use” means the conditions treated articles will see under normal distribution and use. Study protocols, analytical methods and appropriate test conditions will be developed for this work during the second quarter 2003 as this reflects a new area of research for the TRP. Results of this study are expected to be complete in the third quarter 2003. The study protocols will be designed to achieve expeditious results while determining whether or not PFOA releases arise from real-world conditions, consistent with EPA’s quality guidelines I procedures. 3. Characterizing Potential Release ofPFOA from Telomer-Based Product Manufacture In February 2003, the TRP presented to EPA a general description of the process chemistry employed in telomer manufacturing and processing operations. As a follow up, the TRP will prepare and submit a generalized process schematic and description to the EPA by end of March 2003. However, each TRP member company uses unique processes in its manufacturing operations. Each member company will provide the location of each US-based TRP member telomer processing and manufacturing facility by March 24, 2003 and meet separately with the Agency to explain its overall individual process, focusing on its operations in the United States. Each member company will also share information about potential release of PFOA or exposure points from its US-based processes by the end of April 20Q3~The companies will define action plans by the end of May 2003 to investigate the potential forPFOA release and exposure. The members of TRP are available to begin discussions immediately and will call individually to schedule these briefings. In addition to the TRP-sponsored studies described above, DuPont, which is the only fully integrated US telomer producer, makes the commitments set forth in Appendix I. 4. Characterizing Potential Release of PFOAfrom Telomer-Treated Article Manufacture The TRP members will examine the potential for PFOA releases or occupational exposures at US facilities that manufacture telomer-treated articles. In order to conduct research on articles of commerce efficiently, we believe this information is best assembled through a release estimate model analysis directed at manufacture of the three primary telomer-treated article types carpet, textiles and paper that are addressed in other TRP workstreams. The TRP will conduct a study to determine the estimates of potential release ofPFOA. In this — — analysis we will attempt to identify potential release points, exposure pathways, and ultimate environmental compartments (air, land, water) for potential PFOA emissions from telomertreated article manufacturing processes. It is our expectation that this analysis will be complete by June I July 2003. The final reports from this analysis will be provided to the EPA no later than August / September 2003. While the release estimate studies are underway, the TRP will proceed to develop and demonstrate the required sampling and analytical methods for PFOA in the mill simulations described below. We expect this work to be completed in the third quarter 2003. The release estimate analysis will be used to first design and then conduct mill simulations ofthe potential release of PFOA from telomer-treated article manufacturing operations. A contract laboratory capable of simulating the actual mill environment under defined and known conditions will be used to verify the data generated in the above release estimate study. The mill simulations are Mr. Stephen L. Johnson March 14, 2003 Page 5 expected to begin during the third quarter 2003. The results from the analysis and simulations will be used to estimate the potential occupational and environmental exposure to PFOA from the specified telomer-treated article manufacturing processes. This work, along with the Product and Article Analysis in Item 1 of this letter, is expected to provide a more comprehensive picture to aid in the understanding of the potential occupational and environmental exposure to PFOA from telomer-treated article manufacturing processes. S. Biodegradation Analysis The TRP will gather information about whether and how telomers might degrade to PFOA through biodegradation under environmentally relevant conditions. The TRP will conduct further biodegradation studies; see “Continuation of TRP Research Activities” for method development studies with the 8-2 Telomer Alcohol to test for the potential generation of PFOA. These studies will follow appropriate OECD protocols for the telomer-based polymeric products used in the Product and Article Analysis (Itemi). These screening tests will provide useful data on the potential for biodegradation to PFOA from major end-use telomer-based polymeric products. TRP will develop the study approach, protocols and rationale, and submit these to the US EPA by April 2003 for review and comment. Then in the second/third quarter 2003, we will conduct the biodegradation analysis of the telomer-basedpolymeric products selected forthe study above. Initial results are expected beginning in July 2003. Final reports will be submitted to EPA as soon as they become avallable. 6. Analysis of Incineration The TRP has begun to compile information on the ultimate fate and disposal routes (incineration versus landfill) of the telomer-based polymeric products and articles treated in the United States. The results ofthis study will be provided to EPA by July 2003. Concurrently, TRP will examine information available on types of incineration tests that may be applicable and will provide this information to EPA by the end ofthe second quarter 2003. Related Activities Information Exchange Over the last several years the TRP member companies have prepared and collected numerous studies and reports about telomers. Many ofthese documents are drawn from the public literature, but some represent unpublished reports. In addition, we have unpublished reports that have been produced for the TRP. Both the published and unpublished documents include summaries from TRP and non-TRP studies on physical-chemical properties, toxicology, pharmacokinetics, and environmental fate and effects. To expedite the flow of information, TRP will provide the EPA with a listing of the documents in the TRP database by March 24, 2003. Copies of the documents will follow as soon as they can be compiled but no later than April 15, 2003. If EPA requests companyspecific information, the company will supply the information to EPA with appropriate confidential business information claims, as provided for under EPA regulations. Mr. Stephen L. Johnson March 14, 2003 Page 6 In addition, TRP will provide new documents, other materials and final study reports to EPA as soon as they become available. Individual companies will also submit documents, information, and final study reports to EPA related to their own studies on products sold in the US market as soon as they become available. Tn addition, TRP will continue to provide periodic briefings to EPA staff to summarize recent results from these telomer-relatcd studies. These briefings are expected to occur at least monthly in 2003. TRP will also provide EPA advance notice of upcoming studies and reports. Product Stewardship for Customers The TRP members are committed to the continued safe manufacture and use of telomerbased products. The TRP acknowledges that it is equally important to continue to establish and support responsible occupational health and environmental practices in the use of telomer products. TRP member companies have in place product stewardship practices with their customers related to the application, use and occupational exposure to telomer-based products, and have each adopted workplace health and safety practices to minimize occupational exposure. These activities are essential parts of long-standing product stewardship programs and are ongoing. Further efforts on occupational product stewardship programs will focus on technical support and assistance to telomer-based product users (customers) to assist them in keeping their occupational safety and health programs current. Accordingly, the TRP members’ product stewardship role is to provide the necessary information, assist in the understanding of the information, and provide support to customers using telomer-based products. The TRP has no single unified product stewardship program. As a result, the TRP member companies plan to have additional product stewardship programs in place by July 2003. These programs will be developed with reference to the Responsible Care guidelines outlined in SOCMA Management Practices / Product Stewardship Code. Each member company will provide documented evidence for their respective programs to EPA by July 2003. In addition, the TRP believes the development and distribution of a “Safe Handling and Use” handbook would be a valuable tool for our customers. This handbook would amplify the basic information contained in MSDS to provide additional information about telomers and suggestions for overall occupational exposure reduction measures for our customers’ consideration. In developing such a product, we would focus on ways to make it userfriendly and practical. This TRP handbook will be developed for customer review by August 2003. Continuation of TRP Research Activities The TRP has had a research program underway for two years, which has focused primarily on the 8-2 Telomer Alcohol. Many of these efforts will be producing important results in 2003. In light of EPA’s expressed interest in the potential formation of PFOA from telomer-based products, the TRP is reconsidering the priority of new work on the 8-2 Telomer Alcohol. The TRP intends to complete the majority of the projects that are already underway. Mr. Stephen L. Johnson March 14, 2003 Page 7 Relative to some of our current work efforts, we very clearly understand there is concern within the EPA that it has taken too long to clarify whether there is biodegradation of our products to PFOA. Much of this time is attributable to our efforts to develop ‘4C-labeled material that could be used in the biodegradation studies. TRP now has a supply of this material. We anticipate the quality and significance of the data we obtain with this ‘4C-labeled material will provide information valuable enough to justify the time and effort spent. Appendix 2 describes the 8-2 Telomer Alcohol workstreams the TRP has completed to date as well as those underway. The results from the completed studies either have been submitted to the US EPA’s Administrative Record 226 (AR-226) or will be submitted as soon as the final report is completed. Appendix 3 contains a list and schedule of the reports from the TRP work on the 8-2 Telomer Alcohol, including those reports that will be provided to EPA during the remainder of 2003. Final study reports from TRP-sponsored studies will be submitted to EPA as soon as they become available. We believe the actions described in this letter represent a responsive and responsible commitment by the TRP member companies to help address EPA’s expressed interest in the potential for PFOA exposure from telomer-based products. We have made these commitments as tangible as possible, including specific timelines. For convenience, we have summarized these commitments and timelines in Appendices 4 and 5. The TRP members appreciate the opportunity to work with EPA on this important matter and agree that communicating the progress on our efforts and sharing of information is important. Accordingly, we will continue to communicate with EPA when important information arises. In closing, we would like to emphasize that the TRP is committed to the continued safe manufacture, processing and use of telomer chemistry. We look forward to working with EPA in the future to achieve these goals. Respectfully submitted, TRP Member Companies Mr. Stephen L. Johnson March 14, 2003 Page Sc&- Signature: Name: Title: (24&frnr )-1- okus.o I%’? _______________________ AGA Chemicals, Inc. Signature: Name: Title: _________________________ Signature: Name: Title: ____ ________ ___________________________________________ ____________ Clariant Gnibll Clariant GmbIl Signature: Title: ________________________ Name: __________________________________ _______________________________ Daikin America, Inc. Signature: Title: ___________________________ Name: _______________________________________ ______________________________ E.L duPont de Neniours & Company HELEIYEU U3/I’f ~z:’iq 1903 AT 703q130111 PAGE 2 (PRINTED PAGE 2) MAR 14 ‘03 15~@0FR CLARIANT LEGAL 704 331 7131 TO 917034138111 P. 02/02 Mr. Stephen L. Johnson March 14, 2003 Page Bb Signature: Name: Title: AGA Chemicals, Inc. Signature: fL~ L~4ia Name: pn.~c Lo Title: /Y)si. .(~2j~ —r~ Signature: Name: ‘Rttnb~re1TtT~nc~ ca (a Title: RP~np~o4d 7~&~ Clariant CmbH Clariant GmbU Signatu’e: Name: _____________ Title: Daikin America, Inc. Signature: Name: Title: E.I. duPont de Neniours & Company ** TOTAL PAGE.02 ‘K* RECEIVED 03/fl 23:06 1903 AT 703’f 139111 03/14/03 FRI 15:20 FAX 256 30~ 5598 PAGE 2 (PRINTED PARE DAIKIN AMERICA 2) J kt 002 Mr. Stephen U Johnscrn Mar’~h 2003 14, Page Sc Sigtatunx Name: Title: AGA Chemicals, Inc. Sign~ture: Signature: Nnme: Title: CJ?Iciant Gnibll Name: Title: Clariaitt Gmbjj Signature: Name: Title: 7~ - .4tc~i~.&~i)F Da~kin America, Inc. Signature: Name: Title: ______ _________________ _________ _______________ _______________ El. duPont tie Nemours & Compauy -d SI IGtSi’9S2 SLWIOd ~if1fll Co tt ae~ 4 RECEIVED fl/l’f 21:35 1903 AT 703’1138111 MAR. 14’2003 14:54 PAGE 2 (PRINTED PAGE 2) #1052 P.002/002 Mr. Stephen L. Johnson. March, 14, 2003 Page Sd Signature: Name: Title: _________ _______________ _______________ AGA Cbemkal.s, Inc. Signature: _____ SignaiBre: ____ Nsnte: Title: _________ Name: Title: ________ __________ __________ Clariant GmbtJ Clariant GmbH Signature: ______ Name: rifle: ______________ ______________ flaikin America, Inc. Signature: Name: ________________________ Title: \\ ~nD4ton ~ El. duPont de Nemours & Company Mr. Stephen L. Johnson March 14, 2003 Page 9 APPENDIX 1 E.I. duPont de Nemours Company (DuPont) Telomer Manufacturing Facility Commitment DuPont manufactures telomers in the United States at the following sites: • • Chambers Works in Deepwater, New Jersey Washington Works in Parkersburg, West Virginia DuPont Commits to the following with respect to manufacturing operations at these sites: 1) Develop site specific plans to assess levels ofPFOA in air and water from manufacturing operations around each site; development of plans will begin not later than 30 days after the date ofthis letter. Conduct site-specific air dispersion modeling for applicable manufacturing operations, using the EPA approved Industrial Source Complex Short Term 3 (ISCSTS) model, as described in EPA’s Guideline on Air Ouality Models (40 C.F.R. Part 51, Appendix W), and assess the results using the air screening levels established in West Virginia. Conduct ground and surface water analyses at each site, and assess the results using the water screening levels established in West Virginia. Use the West Virginia screening levels to determine what additional actions, if any, may need to be taken, after reviewing the information with EPA. 2) 3) 4) Six months after this Letter is submitted, reports will be submitted foreach site on progress made with respect to environmental assessments. In addition to the environmental assessment comniitments made above, DuPont will, by April 1, 2003, provide EPA with applicable existing industrial hygiene air monitoring data forPFOA from DuPont operations at Chambers Works. Also by April 1, 2003, the DuPont telomers business will provide EPA with summary data on existing employee blood monitoring results (taking steps to preserve confidentiality) from telomer manufacturing operations and PFOA recycle operations at Chambers Works. Mr. Stephen L. Johnson March 14, 2003 Page 10 APPENDIX 2 Summary of TRP Research Activities on 8-2 Telomer Alcohol 8-2 Telomer Alcohol Studies StudyDescription ** Work Complete I STATUS complete complete complete Complete complete Work Underway 2001 I 2002 j 2003 I1Qj2QI3QI4OI1Q~2Q~3Qj4QI1QI2QI3QI4QI ~.cute ral Toxicity O Repeated-Dose Range-Finding Oral Toxicity Study Subchronic 90 Day Oral Gavage (Rat) with 90-Day Recovery Bacterial Reverse Mutation Bone Marrow Erythrocyte Micronucleus Test (Rat) I I Hydrolytic ~ cy ~.dsorption-Desorption: Method Analytical ~dsorptionDesorption: Soil, Sediment & Sludge (14C) ~erobic Biodegradation (cold material, screening, method ~evelopment standards preparation) & ~erobic Biodegradation (14C) ~tmospheric egradation! Indirect Photolysis in Air D Long-Range Transport Properties (Air / Water) O.cute Fish: Fathead Minnow ~.cute Invertebrate: Daphn!a magna ~.cute Chronic Algae (72 Hour) & ~.cute Earthworm (14 Day~ ~cutePlant Seedling (21 Day) Chronic Nematode (3 Day) Chronic Daphnia Magna (21 Day) Hater Solubility & Water Analytical Method UVNisible Absorption Spectrum vapor Pressure Sorption Properties rat.’ complete complete in progress complete in progress complete in progress complete complete complete complete complete complete in progress complete complete complete complete III I Method Development & Material Handling Pilot Experiments! Interim Results complete in prc~ress Chemical Synthesis Development & Demonstration (cold) Develop. Demonstrate & Document Analytical Methods Prepare Cold Standards for Synthesis Route Prepare “C Material as Standard Cold Synthesis Demonstration complete complete complete complete — — complete 14C Synthesis and Preparation of Study Material complete — — ____________ — — — ** The results from the completed studies either have been submitted to EPA’s Administrative Record 226 (AR-226) or will be submitted as soon as the final report is completed. Mr. Stephen L. Johnson March 14, 2003 Page 11 APPENDIX 3 TRP Final Report Schedule (8-2 Telomer Alcohol Studies) The Telomer Research Program (TRP) plans to submit final study reports to the US EVA, according to the schedule below. TRP will be keep EPA apprised of any modifications to the reporting schedule. [Note: Most of the TRP studies listed below were focused on 8-2 Telomer Alcohol (C8F17CH2CH2OH; CAS #678-39-7), a primary fluorotelomer intermediate.] January 2003 (submitted) — — — Acute Oral Toxicity Fixed Dose Method In vivo Rat Micronucleus Assay Salmonella-K coli/Mammalian-Microsome Reverse Mutation Assay — March 2003 Submitted Acute Aquatic Toxicity Tests: Fish (Zebrafish), Daphnia magna, Algae (Scenedesmus subspicatus) o Limit Test with the Saturated Solution o Limit Test with the Water Accommodated Fraction (WAF) Microbial Respiration Inhibition Test with Activated Sludge — — Forthcoming Physical-Chemical Properties of 8-2 Telomer Alcohol: Ultraviolet / Visible Absorption Spectrum, Vapor Pressure, Water Solubility and Sorption Properties Hydrolytic Stability of 8-2 Telomer Alcohol as a Function of pH Atmospheric Degradation ofthe Fluorinated Alcohol, C8F17C112CH2011 Terrestrial Toxicity Studies: Earthworm, Nematode, Plants Repeated Dose Oral Toxicity Gavage Range Finding Study in Rats Subehronic Toxicity 90-day Oral Gavage Study in Rats Bioconcentration in Carp [Note: This study was conducted for Japan METI and provided to the TRP. TRP did not fund the study directly but arranged for the translation into English.] University ofToronto Year 1 Progress Report on Fluorotelomer Alcohols — — — — — — — — May / June 2003 — — Aerobic Ready Biodegradation of 14C-Labeled 8-2 Telomer Alcohol (Modified OECD 301D) with transformation products and mass balance Chronic Toxicity Study (21-day Daphnia) -- Future Submissions in 2003 (studies not yet underway) — — Adsorption / Desorption of 8-2 Telomer Alcohol using a Batch Equilibrium Method 2003 Long-Range Transport Properties (Air!Water) Qtr 4 / 2003 — — Qtr 3 I Mr. Stephen L. Johnson March 14, 2003 Page 12 APPENDIX 4 TRP Conunitment Summary In this Letter ofIntent to the US EPA, the Telomer Research Program (TRP) outlines six areas of commitment and agrees to provide EPA with documents / submissions on specific plans and activities to follow through on these items. The commitment items and dates are summarized below. 1. Product and Article Analysis Note: The products to be tested are those that the respective TRP member companies manufacture as actual items of commerce. The treated articles to be tested are actual carpet, textile, and papersubstrates treated under representative mill conditions with the subject telomer-based polymericproducts. Description ofscope and rationale for analyzing for PFOA in telomer-based polymeric products and telomer-treated articles. This study will cover representative polymeric products in commerce and the major end-use applications (carpet, textiles, and paper). Complete in March 2003. Information from individual companies under CBI about each telomer-based polymeric product to be tested in this study (CAS number, chemical name or structural representation if no CAS number, product, 2002 use and volume) to EPA by March 24, 2003. Description of other telomer-based products (including non-polymeric products) and applications in the United States not included in the Product and Article Analysis, including CAS number, chemical name or structural representation if no CAS number, product and 2002 use and volume in commerce to be provided by individual companies under CBI by May 2003. Submit draft study plans for Product and Article Analysis and Sampling Guidance to EPA forreview and comment completed on February 14, 2003. Conduct analytical and sample method development by March / April 2003; conduct product and article analysis by MayI June 2003. Submit final report from screening study on Product and Article Analysis by June / July 2003. — — — — — — — — — — — — 2. Analysis of “Aged” Products and “In Use”Articles Note: For these analyses, “aged” means the storage and distribution ofproducts. “In-use” means the distribution and use of the treated articles. Develop plan for conducting PFOA “aging” and “in use” analytical studies in initial enduse segments of carpet, textiles, and paper by April 2003. Address specific issues such as residual monomers, leaching, degradation, “walk off,” volatilization, and light exposure. Develop appropriate study protocols, analytical methods and appropriate test conditions to conductthese tests during Qtr 2 I 2003. Conduct “aging” and “in use” analyses of the specific products and treated articles (carpet, textiles, paper) in the TRP-sponsored work under Item 1 above, once protocols and methods are available expected to be completed by Qtr 3 / 2003. — — — — Mr. Stephen L. Johnson March 14, 2003 Page 13 3. Characterizing Potential Release ofPFOA from Telom er-Based Product Manufacture Prepare general description of the process chemistry employed in telomer manufacturing and processing operations —by end of March 2003. Provide the location of each US TRP member telomer manufacturing and processing facility by March 24, 2003. Describe specific telomer manufacturing process chemistry by member companies and information about potential releases of PFOA and exposure routes from these processes (US operations) by end ofApril 2003. Develop action plans (by TRP member companies) to investigate the potential for PFOA release and exposure by end of May 2003. — — — — — — — 4. Characterizing Potential Release ofPFOA from Telomer-Treated Article Manufacture Develop estimates of potential release ofPFOA related to manufacture of the primary article types (carpet, textiles and paper) by June I July 2003. The release scenarios to be developed will cover potential occupational and environmental exposure related to the potential release of PFOA from article manufacture. Provide EPA with results of release estimations of PFOA by August / September 2003. Develop and demonstrate required sampling and analytical methods for PFOA determination in the mill simulations in Qtr 3 / 2003. Conduct mill simulations of the potential releases of PFOA from telomer-treated article manufacture to quantify the potential occupational and environmental exposure related to PFOA from article manufacture begin during Qtr 3 / 2003. — — — — — — — — 5. Biodegradation Analysis Develop study approach, protocols and rationale for conducting biodegradation analyses oftelomer-based polymeric products used in the Product and Article Analysis (Item 1 above) provide to EPA by April 2003 for review and Comment. Conduct biodegradation studies for potential generation ofPFOA from polymeric products used in the Product and Article Analysis during Qtr 2-3 / 2003. Submit results of polymer biodegradation analyses as they become available expected to begin in July 2003. — — — — — — 6. Analysis ofIncineration Compile information on telomer-based polymeric products and uses to understand the ultimate fate and disposal routes (landfill versus incineration) fortelomer-treated articles in the United States provide to EPA by July 2003. Review information on types ofincineration tests that may be applicable and provide this information to EPA by end of Qtr 2 / 2003. — — — Mr. Stephen L. Johnson March 14, 2003 Page 14 Related Activities Information Exchange Listing of documents in the TRP database submit list to EPA by March 24, 2003. The documents will follow as soon as they can be compiled, but no later than April 15, 2003. The documents are TRP and non-TRP reports on physical-chemical properties, toxicology, pharmacokinetics, and environmental fate and effects. TRP will provide new documents, other materials, and final study reports to EPA as soon they become available. Individual companies will also submit documents, information, and final study reports to EPA related to their own studies on products sold in the US — — — — market, as soon as they become available. TRP will continue to provide periodic briefings to EPA staff to summarize current results from these telomer-related studies. These briefings are expected to occur at least monthly in 2003. TRP will provide EPA advance notice for upcoming studies and report timing. Product Stewardship for Customers TRP member companies will have additional product stewardship programs in place by July 2003 developed with reference to the Responsible Care guidelines outlined in the SOCMA Management Practices / Product Stewardship Code. Each company will provide documented evidence for their respective programs by July 2003. Develop TRP Safe Handling and Use Handbook for customer review by August 2003. — — — — Continuation of TRP Research Activities — Proceed with studies on 8-2 Telomer Alcohol in areas of physical-chemical properties, toxicity, pharmacokinetics, and environmental fate and effects (see Appendix 2). — — Describe the method development and preliminary biodegradation studies conducted on 8-2 Telomer Alcohol (types ofstudies and rationale) by March 2003. Submit results from biodegradation analysis of 8-2 Telomer Alcohol with both cold and ‘4C-labelecl material by March 21, 2003 (DuPont preliminary screening cold study) and June / July 2003 (TRP 14C-labeled study). — — — Submit final study reports from all TRP-sponsored studies to EPA as soon as they become available. — A schedule ofTRP final report submissions for the 8-2 Telomer Alcohol studies is provided in the LOl Appendix 3. An updated list will be provided to EPA monthly in 2003. Mr. Stephen L. Johnson March 14, 2003 Page 15 APPENDIX 5 TRP Commitment Summary (Chronological Order) March 2003 1. Product and Article Analysis: Description of scope and rationale for analyzing for PFOA in telomer-based polymeric products and telomer-treated consumer articles. This initial study covers representative polymeric products in commerce and the major end-use applications (carpet, textiles, paper). Draft study plans were provided to EPA in February 2003 for review. 2. Product and Article Analysis: Information from individual companies under CBI about each telomer-based polymeric product to be tested in this study (CAS number, chemical name or structural representation if no CAS number, product, 2002 use and volume in commerce). 3. Characterize Potential Release of PFOA from Telomer-Based Product Manufacture: Provide general description of the process chemistry employed in telomer manufacturing and processing operations. Provide Location of each US TRP member telomer manufacturing and processing facility. 4. Biodegradation Studies (8-2 Telomer Alcohol): Description ofthe method development and preliminary biodegradation studies conducted on 8-2 Telomer Alcohol (types of studies and rationale). 5. Biodegradation Studies (8-2 Telomer Alcohol): Deliver results from biodegradation analysis of 8-2 Telomer Alcohol with cold material (DuPont preliminary screening study). 6. Information Exchange: Submit list of documents, other materials and final study reports contained in the TRP database; documents to follow when compiled (April). April 2003 1. Product and Article Analysis: Conduct analytical and sample method development. 2. Analysis of “Aged” Products and “In Use” Articles: Submit plan forconducting PFOA “aging” and “in use” analytical studies in initial end-use segments of carpet, textiles, and paper. Address specific issues such as residual monomers, leaching, degradation, “walk off,” volatilization, and light exposure. 3. Characterize Potential Release of PFOA from Telomer-Based Product Manufacture: Description of specific telomer manufacturing process chemistry by member companies and information about potential releases ofPFOA and exposure routes from these processes (US operations). 4. Biodegradation Analysis (Polymeric Products): Provide for EPA review the study approach, protocols and rationale forbiodegradation analysis of polymeric products in the Product and Article Analysis (Item 1). 5. Information Exchange: Provide copies ofdocuments and other materials from the TRP database. Mr. Stephen L. Johnson March 14, 2003 Page 16 May 2003 1. Product and Article Analysis: Description of other telomer-based products (including nonpolymeric products) and applications in the United States not included in the Product and Article Analysis, including CAS number, chemical name or structural representation if no CAS number, product, 2002 use and volume in commerce to be provided by individual companies under CBI. 2. Product and Article Analysis: Conduct product and article analyses and compile results. 3. Characterize Potential Release of PFOA from Telomer-Based Product Manufacture: TRP member companies will develop action plans to investigate the potential for PF&A release and exposure. — June 2003 1. Analysis of “Aged” Products and “In Use” Articles: Develop appropriate analytical methods and study protocols to conduct these analyses. TRP will need to define appropriate “aging” and “in use” conditions to conduct these tests. 2. Characterize Potential Release of PFOA from Telomer-Treated Article Manufacture: Develop estimates of potential release of PFOA related to the manufacture oLthree primary article types (carpet, textiles and paper). The release scenarios to be developed will cover occupational and environmental exposure related to potential release of PFOA from article manufacture. 3. Analysis of Incineration: Review information on types of incineration tests that may be applicable and provide a summary to EPA. July 2003 1. Product and Article Analysis: Submit final report from screening study on Product and Article Analysis 2. Characterize Potential Release of PFOA from Telomer-Treated Article Manufacture: Develop and demonstrate required sampling and analytical methods for PFOA determination in the mill simulations. 3. Biodegradation Studies (8-2 Telomer Alcohol): Deliver results from biodegradation analysis of 8-2 Telomer Alcohol with 14C-labeled material (TRP study). 4. Biodegradation Analysis (Polymeric Products): Conduct biodegradation analysis for PFOA ofpolymeric products used in the Product and Article Analysis under Item 1. 5. Analysis of Incineration: Compile information on telomer-based polymeric products and uses to understand the ultimate fate and disposal routes (landfill versus incineration) for telomer-treated articles in the United States. 6. Product Stewardship for Customers: TRP member companies will have additional product stewardship programs in place developed with reference to for ResponsibleCare guidelines outlined in the SOCMA Management Practices / Product Stewardship Code. August 2003 1. Characterize Potential Release of PFOA from Telomer-Treated Article Manufacture: Submit results of release estimations of PFOA from article manufacture. Mr. Stephen L. Johnson March 14, 2003 Page 17 2. Biodegradation Analysis (Polymeric Products): Submit results of biodegradation analyses for PFOA in polymeric products. 3. Product Stewardship for Customers: Provide TRP Safe Handling and Use Handbook to customers for review. September 2003 1. Analysis of “Aged” Products and “In Use” Articles: Conduct “aging” and “in use” analyses of the specific products and treated articles (carpet, textiles, paper) in TRPsponsored work under Item 1, once methods and protocols are available study conducted. 2. Characterize Potential Release of PFOA from Telomer-Treated Article Manufacture: Initiate mill simulations of the potential release of PFOA from telomer-treated article manufacture to estimate the potential occupational and environmental exposure of PFOA from article manufacture. Continue mill simulations into Qtr 4 / 2003.