Federal Register/Vol. 68, No. 73/Wednesday, April 16, 2003/Notices

18626 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Notices

categorically excluded from the ADDRESSES: Submit your comments, regarding the applicability of this action preparation of an environmental identified by docket ID number OPPT– to a particular entity, consult the assessment or an environmental impact 2003–0012, online at http:// technical person listed under FOR statement. www.epa.gov/edocket/ (EPA’s preferred FURTHER INFORMATION CONTACT. method), or by mail to EPA Docket Determination Under Executive Order B. How Can I Get Copies of this Center (7407), Environmental Protection Document and Other Related 12866 Agency, 1200 Pennsylvania Ave., NW., Information? Western has an exemption from Washington, DC 20460–0001. For centralized regulatory review under additional comment submission 1. Docket. EPA has established an Executive Order 12866. This notice is methods and detailed instructions, go to official public docket for this action not required to be cleared by the Office Unit I.C. of the SUPPLEMENTARY under docket identification (ID) number of Management and Budget. INFORMATION. OPPT–2003–0012. The official public Dated: March 27, 2003. Submit your notification for docket consists of the documents ‘‘interested party’’ status separately from specifically referenced in this action, Michael S. Hacskaylo, any comments submitted, identified any public comments received, and Administrator. ‘‘Attention: PFOA ECA Notification’’ by other information related to this action. [FR Doc. 03–9325 Filed 4–15–03; 8:45 am] mail to Brigitte Farren, Chemical Although a part of the official docket, BILLING CODE 6450–01–P Control Division (7405M), Office of the public docket does not include Pollution Prevention and Toxics, Confidential Business Information (CBI) Environmental Protection Agency, 1200 or other information whose disclosure is ENVIRONMENTAL PROTECTION Pennsylvania Ave., NW., Washington, restricted by statute. The official public AGENCY DC 20460–0001. To protect personal docket is the collection of materials that [OPPT–2003–0012; FRL–7303–8] information from disclosure to the is available for public viewing at the public, please submit these notifications EPA Docket Center, Rm. B102–Reading Perfluorooctanoic Acid (PFOA), separately from your comments and do Room, EPA West, 1301 Constitution Fluorinated Telomers; Request for not use any online electronic Ave., NW., Washington, DC. Additional Comment, Solicitation of Interested commenting system to submit this information concerning the topics Parties for Enforceable Consent notification. discussed in this notice can be found in Agreement Development, and Notice of The public meeting to initiate Administrative Record (AR)–226: PFOS, Public Meeting negotiations on ECAs for PFOA and PFOA, Telomers, and Related telomers will be held at the Chemicals, which was established by AGENCY: Environmental Protection Environmental Protection Agency, EPA the Agency in 2000 to receive Agency (EPA). East Bldg., Rm. 1153, 1201 Constitution information on various fluorinated ACTION: Notice. Ave., NW., Washington, DC. chemicals, including PFOA. These FOR FURTHER INFORMATION CONTACT: For materials are also available in the EPA SUMMARY: EPA has identified potential general information contact: Barbara Docket Center. The EPA Docket Center human health concerns from exposure Cunningham, Director, Environmental is open from 8:30 a.m. to 4:30 p.m., to perfluorooctanoic acid (PFOA) and its Assistance Division (7408M), Office of Monday through Friday, excluding legal salts, although there remains Pollution Prevention and Toxics, holidays. The EPA Docket Center considerable scientific uncertainty Environmental Protection Agency, 1200 Reading Room telephone number is regarding potential risks. EPA is Pennsylvania Ave., NW., Washington, (202) 566–1744 and the telephone requesting public comment on pertinent DC 20460–0001; telephone number: number for the OPPT Docket, which is topics of interest, as discussed in this (202) 554–1404; e-mail address: TSCA- located in EPA Docket Center, is (202) document, and the submission of [email protected]. 566–0280. additional data concerning these For technical information contact: 2. Electronic access. You may access chemicals. EPA is also soliciting the Mary Dominiak, Chemical Control this Federal Register document identification of interested parties who Division (7405M), Office of Pollution electronically through the EPA Internet want to monitor or participate in Prevention and Toxics, Environmental under the ‘‘Federal Register’’ listings at negotiations on one or more enforceable Protection Agency, 1200 Pennsylvania http://www.epa.gov/fedrgstr/. consent agreements (ECAs) under Ave., NW., Washington, DC 20460– An electronic version of the public section 4 of the Toxic Substances 0001; telephone number: (202) 564– docket is available through EPA’s Control Act (TSCA) concerning PFOA 8104; e-mail address: electronic public docket and comment and fluorinated telomers which may [email protected]. system, EPA Dockets. You may use EPA metabolize or degrade to PFOA, and is Dockets at http://www.epa.gov/edocket/ announcing the first public meeting for SUPPLEMENTARY INFORMATION: to submit or view public comments, these ECA negotiations. I. General Information access the index listing of the contents DATES: Comments on this notice must be of the official public docket, and to received on or before May 16, 2003. A. Does this Action Apply to Me? access those documents in the public Notify EPA in writing on or before This action is directed to the public docket that are available electronically. May 16, 2003 of your desire to be in general, and may be of particular Although not all docket materials may accorded ‘‘interested party’’ status for interest to manufacturers, importers, be available electronically, you may still the purpose of participating in or processors, exporters, distributors, and access any of the publicly available monitoring the negotiations for users of PFOA, fluoropolymers, docket materials through the docket development of ECAs concerning PFOA fluoroelastomers, and telomer facility identified in Unit I.B.1. Once in and telomers. chemicals. Since other entities may also the system, select ‘‘search,’’ then key in A public meeting has been scheduled be interested, the Agency has not the appropriate docket ID number. to initiate negotiations on an ECA for attempted to describe all the specific Certain types of information will not PFOA and telomers, from 1 p.m. to 5 entities that may be affected by this be placed in the EPA Dockets. p.m., on Friday, June 6, 2003. action. If you have any questions Information claimed as CBI and other

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information whose disclosure is notification should be submitted ‘‘anonymous access’’ system. If you restricted by statute, which is not separately from any comments on this send an e-mail comment directly to the included in the official public docket, document using the specific docket without going through EPA’s will not be available for public viewing instructions provided under ADDRESSES. electronic public docket, EPA’s e-mail in EPA’s electronic public docket. EPA’s Do not use any online electronic system automatically captures your e- policy is that copyrighted material will commenting system to submit this mail address. E-mail addresses that are not be placed in EPA’s electronic public notification.) To ensure proper receipt automatically captured by EPA’s e-mail docket but will be available only in by EPA, identify the appropriate docket system are included as part of the printed, paper form in the official public ID number in the subject line on the first comment that is placed in the official docket. To the extent feasible, publicly page of your comment. Please ensure public docket, and made available in available docket materials will be made that your comments are submitted EPA’s electronic public docket. available in EPA’s electronic public within the specified comment period. iii. Disk or CD ROM. You may submit docket. When a document is selected Comments received after the close of the comments on a disk or CD ROM that from the index list in EPA Dockets, the comment period will be marked ‘‘late.’’ you mail to the mailing address system will identify whether the EPA is not required to consider these identified in Unit I.C.2. These electronic document is available for viewing in late comments. If you wish to submit submissions will be accepted in EPA’s electronic public docket. CBI or information that is otherwise WordPerfect or ASCII file format. Avoid Although not all docket materials may protected by statute, please follow the the use of special characters and any be available electronically, you may still instructions in Unit I.D. Do not use EPA form of encryption. access any of the publicly available Dockets or e-mail to submit CBI or 2. By mail. Send your comments to: docket materials through the docket information protected by statute. Document Control Office (7407M), facility identified in Unit I.B.1. EPA 1. Electronically. If you submit an Office of Pollution Prevention and intends to work towards providing electronic comment as prescribed in this Toxics (OPPT), Environmental electronic access to all of the publicly unit, EPA recommends that you include Protection Agency, 1200 Pennsylvania available docket materials through your name, mailing address, and an e- Ave., NW., Washington, DC 20460– EPA’s electronic public docket. mail address or other contact 0001. For public commenters, it is information in the body of your 3. By hand delivery or courier. Deliver important to note that EPA’s policy is comment. Also include this contact your comments to: OPPT Document that public comments, whether information on the outside of any disk Control Office (DCO) in EPA East Bldg., submitted electronically or in paper, or CD ROM you submit, and in any Rm. 6428, 1201 Constitution Ave., NW., will be made available for public cover letter accompanying the disk or Washington, DC. Attention: Docket ID viewing in EPA’s electronic public CD ROM. This ensures that you can be Number OPPT–2003–0012. The DCO is docket as EPA receives them and identified as the submitter of the open from 8 a.m. to 4 p.m., Monday without change, unless the comment comment and allows EPA to contact you through Friday, excluding legal contains copyrighted material, CBI, or in case EPA cannot read your comment holidays. The telephone number for the other information whose disclosure is due to technical difficulties or needs DCO is (202) 564–8930. restricted by statute. When EPA further information on the substance of D. How Should I Submit CBI To the identifies a comment containing your comment. EPA’s policy is that EPA Agency? copyrighted material, EPA will provide will not edit your comment, and any a reference to that material in the identifying or contact information Do not submit information that you version of the comment that is placed in provided in the body of a comment will consider to be CBI electronically EPA’s electronic public docket. The be included as part of the comment that through EPA’s electronic public docket entire printed comment, including the is placed in the official public docket, or by e-mail. You may claim copyrighted material, will be available and made available in EPA’s electronic information that you submit to EPA as in the public docket. public docket. If EPA cannot read your CBI by marking any part or all of that Public comments submitted on comment due to technical difficulties information as CBI (if you submit CBI computer disks that are mailed or and cannot contact you for clarification, on disk or CD ROM, mark the outside delivered to the docket will be EPA may not be able to consider your of the disk or CD ROM as CBI and then transferred to EPA’s electronic public comment. identify electronically within the disk or docket. Public comments that are i. EPA Dockets. Your use of EPA’s CD ROM the specific information that is mailed or delivered to the docket will be electronic public docket to submit CBI). Information so marked will not be scanned and placed in EPA’s electronic comments to EPA electronically is disclosed except in accordance with public docket. Where practical, physical EPA’s preferred method for receiving procedures set forth in 40 CFR part 2. objects will be photographed, and the comments. Go directly to EPA Dockets In addition to one complete version of photograph will be placed in EPA’s at http://www.epa.gov/edocket/, and the comment that includes any electronic public docket along with a follow the online instructions for information claimed as CBI, a copy of brief description written by the docket submitting comments. Once in the the comment that does not contain the staff. system, select ‘‘search,’’ and then key in information claimed as CBI must be docket ID number OPPT–2003–0012. submitted for inclusion in the public C. How and To Whom Do I Submit The system is an ‘‘anonymous access’’ docket and EPA’s electronic public Comments? system, which means EPA will not docket. If you submit the copy that does You may submit comments know your identity, e-mail address, or not contain CBI on disk or CD ROM, electronically, by mail, or through hand other contact information unless you mark the outside of the disk or CD ROM delivery/courier. (Please note, however, provide it in the body of your comment. clearly that it does not contain CBI. that to protect personal information ii. E-mail. Comments may be sent by Information not marked as CBI will be from disclosure to the public, you e-mail to [email protected], Attention: included in the public docket and EPA’s should not follow the instructions in Docket ID Number OPPT–2003–0012. In electronic public docket without prior this section to submit your notification contrast to EPA’s electronic public notice. If you have any questions about for ‘‘interested party’’ status. Such docket, EPA’s e-mail system is not an CBI or the procedures for claiming CBI,

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please consult the technical person making this preliminary assessment months. However, as explained in this listed under FOR FURTHER INFORMATION public in order to identify the Agency’s notice, there remain substantial CONTACT. concerns, to indicate areas where uncertainties associated with the additional information or investigation preliminary risk assessment. EPA E. What Should I Consider as I Prepare would be useful, and to request the believes these uncertainties may be My Comments for EPA? submission of data addressing these reduced through acquisition of the We invite you to provide your views issues. information described in this notice. on the various options we propose, new EPA is also soliciting the EPA is therefore continuing the priority approaches we have not considered, the identification of parties who would be review in order to acquire this potential impacts of the various options interested in monitoring or participating information and better inform the (including possible unintended in negotiations for the development of Agency’s decisionmaking. consequences), and any data or one or more ECAs under section 4 of A. PFOA Sources and Uses information that you would like the TSCA on PFOA and on fluorinated Agency to consider during the telomers (hereafter ‘‘telomers’’) which PFOA and its salts are fully development of the final action. You may metabolize or degrade to PFOA. fluorinated organic compounds that can may find the following suggestions The intent of the ECAs would be to be produced synthetically and formed helpful for preparing your comments: develop additional information, through the degradation or metabolism 1. Explain your views as clearly as particularly environmental fate and of certain other manmade possible. transport information, to enhance fluorochemical products. PFOA is a 2. Describe any assumptions that you understanding of the sources of PFOA synthetic chemical and is not naturally used. in the environment and the pathways by occurring. Consequently, all PFOA in 3. Provide copies of any technical which human exposure to PFOA is the environment is attributable to information and/or data you used that occurring. human activity. support your views. PFOA is used primarily to produce its 4. If you estimate potential burden or III. Background salts, which are used as essential costs, explain how you arrived at the In 1999, EPA began an investigation processing aids in the production of estimate that you provide. after receiving data on perfluorooctyl fluoropolymers and fluoroelastomers. 5. Provide specific examples to sulfonate (PFOS) indicating that PFOS Although they are made using PFOA, illustrate your concerns. was persistent, unexpectedly toxic, and finished fluoropolymer and 6. Offer alternative ways to improve bioaccumulative. These data also fluoroelastomer products are not the notice or collection activity. showed that PFOS had been found in expected to contain PFOA. In recent 7. Make sure to submit your very low concentrations in the blood of years, less than 600 metric tons per year comments by the deadline in this the general population and in wildlife of PFOA and its salts have been notice. around the world. 3M Company (3M), manufactured or imported in the United 8. To ensure proper receipt by EPA, the sole manufacturer of PFOS in the States (Ref. 6). The major be sure to identify the docket ID number United States and the principal fluoropolymers manufactured using assigned to this action in the subject manufacturer worldwide, announced in PFOA salts are polytetrafluoroethylene line on the first page of your response. May 2000 that it was discontinuing its (PTFE) and polyvinylidine fluoride You may also provide the name, date, perfluorooctanyl chemistries, including (PVDF). PTFE has hundreds of uses in and Federal Register citation. PFOS. EPA followed the voluntary 3M many industrial and consumer phaseout with regulatory action under products, including soil, stain, grease, II. What Action is the Agency Taking? TSCA section 5 to limit any future and water resistant coatings on textiles EPA has prepared a preliminary risk manufacture or importation of PFOS and carpet; uses in the automotive, assessment (Ref. 1) on perfluorooctanoic before EPA has had an opportunity to mechanical, aerospace, chemical, acid (PFOA) (Octanoic acid, review activities and risks associated electrical, medical, and building/ pentadecafluoro-; Chemical Abstracts with the proposed manufacture or construction industries; personal care Service Registry Number (CAS No.) importation (Ref. 2). products; and non-stick coatings on 335–67–1) and its salts, predominantly In June 2000, EPA indicated that it cookware. PVDF is used primarily in ammonium perfluorooctanoate (APFO) was expanding its investigation of PFOS three major industrial sectors: (Octanoic acid, pentadecafluoro-, to encompass other fluorochemicals, Electrical/electronics, building/ ammonium salt (CAS No. 3825–26–1)). including PFOA, in order to determine construction, and chemical processing. This preliminary assessment indicates whether these other fluorochemicals PFOA can be commercially potential nationwide human exposure might present concerns similar to those manufactured by two major alternative to low levels of PFOA. Based on certain found with PFOS. EPA was concerned processes: The Simons Electro-Chemical animal studies, there could be a in part because 3M had also found Fluorination (ECF) process, and a potential risk of developmental and PFOA in human blood during the telomerization process. Releases from other adverse effects associated with studies on PFOS (Ref. 3). manufacturing processes are one source these exposures in humans. However, In September 2002, the Director of of PFOA in the environment. this assessment also reflects substantial OPPT initiated a priority review on Historically, most U.S. production was uncertainty about the interpretation of PFOA because the developmental by 3M using the ECF process. 3M the risk. EPA has identified areas where toxicity data, the carcinogenicity data, discontinued its manufacture of PFOA additional information could be very and the blood monitoring data between 2000 and 2002, and other helpful in allowing the Agency to presented in an interim revised hazard domestic producers are using the develop a more accurate assessment of assessment raised the possibility that telomerization process exclusively. the potential risks posed by PFOA and PFOA might meet the criteria for In the ECF process, an electric current the other compounds addressed in this consideration under TSCA section 4(f) is passed through a solution of notice, and to identify what voluntary or (Refs. 4 and 5). When the priority anhydrous hydrogen fluoride and an regulatory mitigation or other actions, if review commenced, EPA anticipated organic feedstock of octanoic acid or a any, would be appropriate. EPA is completing the review within a few derivative. The ECF process replaces the

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carbon-hydrogen bonds on molecules of not been tested to determine whether the other hormone levels analyzed the organic feedstock with carbon- they may also metabolize or degrade to indicated any adverse effects. fluorine bonds. Perfluorination occurs form PFOA. Telomers are used widely APFO is the most widely used salt of when all the carbon-hydrogen bonds are in a range of commercial products, PFOA, and most animal toxicity studies replaced with carbon-fluorine ones. The including some that are directly have been conducted with APFO. An ECF process yields between 30–45% released into the environment, such as extensive array of animal toxicity straight chain (normal) fire fighting foams, as well as soil, stain, studies have been conducted in rodents perfluorooctanonyl fluoride (PFOF), and grease resistant coatings on carpets, and monkeys. These studies have along with a variable mixture of textiles, paper, and leather. The extent shown that APFO exposure can result in byproducts and impurities. The output to which these telomer-containing a variety of toxic effects in animals of the ECF process consists of a complex products might degrade to release PFOA including liver toxicity, developmental combination of chemical substances is unknown. However, anecdotal toxicity, and immunotoxicity. In with varying molecular weights, evidence of the atmospheric presence of addition, rodent bioassays have shown including higher and lower straight- telomer alcohols in a multi-city North that chronic APFO exposure is chain homologues; branched-chain American survey suggests that telomers associated with a variety of tumor types. perfluoroalkyl fluorides of various chain may be one source of environmental The mechanisms of APFO lengths; straight-chain, branched, and PFOA (Ref. 10). Additional fate tumorigenesis are not clearly cyclic perfluoroalkanes and ethers; and information is necessary to determine understood. At this time, EPA is other byproducts. After disposal or whether and the extent to which evaluating the scientific evidence and recovery of some of the byproducts and telomer product degradation may be a has not reached any conclusions on the impurities, the acid fluoride is base source of PFOA. potential significance to humans of the hydrolyzed in batch reactors to yield EPA is not currently aware of any rodent cancer data. PFOA. The PFOA salts are synthesized other potential sources of PFOA in the There are marked gender differences by base neutralization of the acid to the environment. EPA specifically requests in the elimination of PFOA in rats. In salt in a separate reactor. comment on this issue, and the addition, there are substantial In the telomerization process, submission of any data identifying or differences in the half-life of PFOA in tetrafluoroethylene is reacted with other characterizing PFOA sources. EPA is rats, monkeys, and humans. The gender fluorine-bearing chemicals to yield especially interested in the thermal and species differences are not fluorinated intermediates which are stability and oxidative degradation completely understood and therefore readily converted into PFOA. This products of materials containing PFOA the extent of potential risks to humans process yields predominantly straight- or telomer chemicals which are is uncertain. chain acids with an even number of incinerated. C. Preliminary Risk Assessment carbon atoms. Distillation can be used to B. Hazard and Exposure obtain pure components. Commercial Because TSCA section 4(f) is focused products manufactured through the EPA has conducted a detailed review narrowly on the specific toxicity telomerization process, sometimes of all available hazard and exposure endpoints of cancer, birth defects, and known as telomers, are generally information on PFOA. This review is gene mutation, the preliminary risk mixtures of perfluorinated compounds available in the Agency’s Revised Draft assessment prepared as part of this with even carbon numbers, although the Hazard Assessment on PFOA and Its priority review focused on the potential process can also produce compounds Salts (Ref. 11). This draft hazard risks for developmental toxicity in with odd carbon numbers. assessment has not been formally peer humans. EPA did not include cancer In addition to releases from the reviewed, but has been reviewed risk in this preliminary assessment due deliberate manufacture of PFOA internally by the EPA Office of Research to questions concerning the potential through either the ECF or telomerization and Development (ORD). significance to humans of the rodent processes, and from the use of PFOA PFOA is persistent in the cancer data. Because data indicate that and its salts in the manufacture and environment. It does not hydrolyze, PFOA is not mutagenic, concern for processing of fluoropolymers and photolyze, or biodegrade under gene mutation was not an issue for this fluoroelastomers, PFOA may have environmental conditions. Based on preliminary assessment. entered the environment through other recent human biomonitoring data The preliminary risk assessment used sources. 3M has indicated that PFOA provided by industry, which found a margin of exposure (MOE) approach may have been present as a trace PFOA in the blood of workers and the (Ref. 1). For many risk assessments, the contaminant in some of the general population in all geographic MOE is calculated as the ratio of the fluorochemical products which it regions of the United States, exposure to administered dose from the animal discontinued manufacturing between PFOA is potentially nationwide, toxicology study to the estimated 2000 and 2002 (Ref. 7). Because these although the routes of exposure for the human exposure level. The human products are no longer being general population are unknown. exposure is estimated from a variety of manufactured, they will likely not be a Several epidemiological studies on potential exposure scenarios, each of significant potential future source of the effects of PFOA in humans have which requires a variety of assumptions. PFOA. been conducted on workers. An A more accurate estimate of the MOE EPA has also received data which association with PFOA exposure and can be derived if measures of internal indicate that the 8–2 telomer alcohol (1- prostate cancer was reported in one dose are available for humans and the Decanol, study; however, this result was not animal model. In this preliminary risk 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10- observed in an update to the study in assessment, serum levels of PFOA, heptadecafluoro- (CAS No. 678–39–7)) which the exposure categories were which are a measure of internal dose, although not itself made with PFOA, modified. A non-statistically significant were available for some administered can be metabolized by living organisms increase in the levels of the hormone dose levels in the rat 2-generation or biodegrade under environmental estradiol in workers with high serum reproductive toxicology study and from conditions to produce PFOA (Refs. 8 PFOA levels (>30 parts per million human biomonitoring studies. Thus, and 9). Other telomer chemicals have (ppm)) was also reported, but none of internal dose was used for the

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calculation of MOEs in this assessment. believes that the additional information the limited geographic locations of The actual values of the MOEs derived identified in this notice would better fluorochemical plants making or using must be viewed with caution, however, inform this priority review and Agency the chemical, suggests that there must due to the differences in kinetics decisionmaking with respect to PFOA. be additional sources of PFOA in the between humans and rodents. The range The sources of PFOA in the environment, and exposures beyond of MOEs in the preliminary assessment environment, as described in Unit II.A., those attributable to direct releases from encompasses some values that would are not fully defined or understood. industrial facilities. But whether these indicate potential concern and other Historically, direct PFOA releases exposures are due to PFOA in the air, values that would indicate a low level during the manufacture of PFOA and its the water, on dusts or sediments, in of concern. Due to the uncertainties in use in the manufacture and processing dietary sources, or through some the assessment, and the possibility that of fluoropolymers and fluoroelastomers combination of routes is currently the additional information discussed in have been quantified at some sites. unknown. Data evaluating the this notice might reduce those Industry has identified and environmental presence of PFOA in uncertainties, the Agency has not implemented voluntary control water are very limited and site-specific. attempted further interpretation of these technologies to reduce releases, as well Data on the presence of PFOA in air or MOEs at this time. The interpretation of as to improve PFOA recovery for soil are not currently available. Data on the significance of the MOEs for recycling or destruction, as described in the presence of PFOA in wildlife ascertaining potential levels of concern Unit II.E. The effectiveness of these suggest that animals are not as likely as will necessitate a better understanding programs could be assessed, possibly humans to have PFOA in their blood, of the appropriate dose metric in rats, through the ECA process described in and that PFOA is not found as widely and the relationship of the dose metric Unit V., by monitoring PFOA levels at in animals as PFOS. Whether these to the human serum levels. the respective facilities and determining differences may be due to different As this priority review of PFOA if the release reduction and waste exposure pathways or to differences in progresses, EPA will continue to management programs are reducing the how the chemicals are processed or develop the characterization of hazard PFOA levels in the media surrounding retained by animals and humans is and potential risk associated with the affected facilities. PFOA exposures unknown. The technical difficulties of exposure to PFOA. Because the and releases to the environment may detecting and accurately measuring the scientific interpretation issues in this also come from the distribution of PFOA chemical in all these various media, case are particularly complex, given the in aqueous dispersions of particularly in the low concentrations unusual properties and behavior of fluoropolymers used by processors to that EPA would anticipate, are PFOA and the absence of data on apply coatings to metals and textiles, a considerable. exposure pathways and levels, EPA topic which industry is also attempting The preliminary risk assessment on anticipates that a more comprehensive to resolve. potential developmental toxicity was risk analysis will be taken to the In addition, the question of the based on a comparison of serum levels Agency’s Science Advisory Board for potential contribution to PFOA levels in the 2-generation rat reproductive review and comment in fall 2003. The from telomer manufacture and from study with those found in the human preliminary risk assessment described telomer product degradation remains. population. However, there are in this notice has not been formally peer The universe of specific telomer considerable species differences in the reviewed, but has gone through internal chemicals that may ultimately degrade kinetics of PFOA. Interpretation of the review by multiple EPA offices, or metabolize to PFOA has not been significance of the MOEs for including ORD, the Office of Science fully defined. Preliminary data suggest ascertaining potential levels of concern Coordination and Policy (OSCP), the that only higher perfluorinated will necessitate a better understanding Office of Pesticide Programs (OPP), and homologues (chemicals with carbon of the appropriate dose metric in rats, the Office of Policy, Economics, and chain lengths of eight and higher) would and the relationship of the dose metric Innovation (OPEI). The preliminary risk be converted into PFOA via normal to the human serum levels. assessment has also been the subject of environmental pathways. The 8–2 Finally, there are some uncertainties an external letter peer review. telomer alcohol has been shown to regarding the use of the human biodegrade and metabolize to form biomonitoring data. Although the D. Uncertainties and Data Needs PFOA, but other telomer chemicals, available data include a range of Although EPA has concerns with including telomer iodides and telomer- populations with various demographics respect to the potential nationwide derived polymers, have not yet been in many States and all geographic areas presence of PFOA in blood and with the tested. Determining possible telomer of the country, there may be some potential for developmental and other product sources of PFOA may be populations that are not represented. effects suggested by animal studies, particularly difficult because these Because it is unknown how the human there are significant uncertainties in the fluorochemicals are typically used in exposures are occurring, proximity to a Agency’s quantitative assessment of the products in very low concentrations, manufacturing facility may or may not risks of PFOA. In addition, the indicating that any individual source be a factor in exposure. However, uncertainties discussed in this unit with contribution by specific products could populations living near these facilities respect to the identification of the be very small, widely distributed, and were not sampled. Therefore, it is pathway or pathways that result in difficult to detect. For example, possible that PFOA serum levels may be human exposure to PFOA (air, water, products contaminated with volatile, underestimated for certain portions of food, etc.), and the uncertainties unreacted telomer alcohol residuals the U.S. population. The children’s associated with how PFOA gets into could potentially release those residuals sample was derived from blood those pathways (including the products into the environment where they could collected in 1994/1995; therefore, it may or processes that are responsible for the be subject to biodegradation. not reflect the current status of PFOA in presence of PFOA in the environment) The exposure routes leading to the children’s blood. make it difficult to determine what, if presence of PFOA in human blood are Voluntary activities by industry are any, particular risk mitigation measures not known. The nationwide presence of underway as described in Unit II.E. to would be appropriate. The Agency PFOA in human blood, contrasted with help address some of these uncertainties

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and data gaps. For example, outlining their plans for continuing Responsible Care programs of the pharmacokinetics studies examining the research and product stewardship American Chemistry Council and the biological processing of PFOA in rats activities (Refs. 7, 12, and 13). These Synthetic Organic Chemical are expected to be completed in the letters have been placed in the public Manufacturers Association in their summer and fall of 2003. These studies docket for this notice and can be efforts to support toxicological research, may help to reduce the uncertainty in accessed as described in Unit I.B.2. The control occupational exposures in their the estimation of risk to humans. In letters contain substantial additional own facilities, monitor employee health, addition, EPA has submitted a information concerning the specifics of assist customers in protecting their nomination to the Centers for Disease the voluntary industry actions beyond employees, and meet the general Control and Prevention (CDC) to include what is presented in this notice. commitment to reduce emissions to the PFOS, PFOA, and certain related In its letter, 3M indicated that it environment. The companies stated that fluorochemicals in the next National would not resume the manufacture of they will continue to use appropriate Health and Nutrition Examination PFOA for commercial sale; that it would criteria, including such standards as the Survey (NHANES). This would provide continue its medical monitoring efforts interim air and water screening levels a national baseline of PFOA exposure, for workers and provide biannual and water quality guidelines recently both to indicate whether current data reports to EPA and update its adopted in West Virginia, to evaluate are representative of the U.S. population epidemiological study reports to EPA operations and emissions (Refs. 14 and and to offer a gauge with which to every 5 years; and that it will continue 15). The letter includes a schedule for measure the effectiveness of actions to monitoring groundwater, surface water, the completion of various studies reduce exposures. and other environmental media and already underway. EPA will continue to develop and provide a summary report to EPA The members of the TRP—AGA clarify issues relating to hazard, within 2 years. 3M also stated that it Chemicals (Asahi Glass); Clariant exposure, and risk as the priority review would work with other members of GmbH; Daikin America, Inc.; and E.I. continues and the Agency receives industry to conduct additional duPont de Nemours & Company— additional information that allows validation of PFOA analytical methods indicated that they comprise the major further resolution of the uncertainties and sampling protocols and to telomer producers, and that they are identified in this unit. participate in human health and evaluating telomer products sold in the Additional data beyond EPA’s current environmental fate and effects studies of United States to determine whether they activities and the voluntary efforts PFOA. 3M also indicated that the contribute to significant human or undertaken by the industry may be facilities and employees of its environmental exposure to PFOA. They necessary to resolve the existing subsidiary, Dyneon LLC, would noted that their evaluation has six key uncertainties and fill remaining data continue to be part of the 3M components: Analysis of products and gaps, including gaps not yet identified. monitoring program. articles; analysis of ‘‘aged’’ products and EPA requests comment on these issues, The members of the FMG—Asahi ‘‘in use’’ articles; characterization of and particularly requests that comments Glass Fluoropolymers USA, Inc.; Daikin potential release of PFOA from telomer- include the submission of any America, Inc.; E.I. duPont de Nemours based product manufacture; additional data that may help to fill & Company; and Dyneon LLC— characterization of potential release of these gaps. Certain specific information indicated that they and their parent PFOA from telomer-treated article requests are identified in Unit IV. companies represent most of the known manufacture; analysis of possible use of APFO for the production of E. Ongoing Voluntary Activities biodegradation of telomer-based fluoropolymers both in the United polymeric products; and evaluation of In 2000, EPA opened a non-regulatory States and worldwide. Their letter the ultimate fate and disposal routes for public docket file, Administrative includes commitments to reduce telomer-treated articles in the United Record AR–226, for information on emissions of APFO from fluoropolymer States. The letter includes lists and PFOS, PFOA, telomers, and related and APFO manufacturing facilities on a schedules for these various evaluation fluorinated chemicals, and began to global, individual company-wide basis components, as well as for the express its concerns to the global by a minimum of 50% by 2006; to submission of additional information to fluorochemical industry (Ref. 3). In conduct studies on both finished the Agency. response, the industry began providing polymers and finished products from EPA appreciates the industry information to the Agency, all of which these polymers to determine if any response to the Agency’s concerns has been placed into AR–226. Two exposure to the general population can regarding PFOA and the telomers, and industry groups, the Fluoropolymer be related to the fluoropolymer looks forward to continued cooperation Manufacturing Group (FMG) and the industry; to conduct studies on on assessment and management Telomer Research Program (TRP), emissions from fluoropolymer activities. EPA invites the participation formed and began pursuing voluntary processing facilities to determine the of additional interested persons in these collective actions to address issues level of current emissions; and to efforts. EPA considers that the timely associated with PFOA and the telomers. develop additional toxicological data on submission of the information which 3M continued its ongoing research APFO. The companies noted that they industry has already committed to efforts despite having discontinued the are participating in activities through provide will be essential to developing manufacture of both PFOS and PFOA. the Association of Plastics a better and more complete Much of the information reflected in the Manufacturers in Europe (APME) to understanding of the potential risks of EPA’s revised draft hazard assessment conduct pharmacokinetics studies in PFOA. However, in light of the concerns and preliminary risk assessment on rats and develop a pharmacokinetic identified to date, the Agency will PFOA was provided through these model, and would share those data with continue its ongoing expeditious voluntary activities on the part of EPA as they are developed, beginning in review. industry. spring 2003. The companies indicated While the voluntary industry In March 2003, EPA received letters that they would continue to follow activities as described in the letters will from 3M, FMG, and TRP documenting principles of product stewardship provide substantial additional their ongoing voluntary programs and similar to those described in the information, EPA considers it likely that

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issues will remain even after these this request any existing data not public of such meeting dates in the activities are complete, and that the otherwise provided to EPA concerning electronic public docket for this action. results of some of these programs may the toxicity, pharmacokinetics, and half- The negotiation time schedule for PFOA well identify additional questions that life of PFOA in organisms. and telomers will be established at the first negotiation meeting. It is EPA’s will need to be answered. EPA requests D. Additional Data comment on these issues. current intent to move quickly to Are there other pieces of information attempt to finalize any ECAs, if possible. IV. Specific Requests for Comments, not addressed in Unit IV. A., B., and C., If an ECA is not established in principle Data, and Information that would help EPA more accurately within a reasonable time-frame, EPA specifically requests comments, assess the risks of these chemicals and negotiations will be terminated, and any data, and information on the following determine appropriate further action, if unmet data needs may be pursued via topics. warranted? a test rule promulgated under TSCA A. Use and Production Volume V. Enforceable Consent Agreement section 4. If the data generated from the Information Development ECA do not meet the Agency’s needs, EPA reserves the right to proceed with What are the specific chemical EPA is interested in developing one or rulemaking to obtain the needed data. identities (by Ninth Collective Index more ECAs under TSCA section 4 and EPA also reserves the right to announce name and CAS No., if available) of the 40 CFR part 790 for PFOA and telomers and convene subsequent ECA telomer chemicals, including polymers that focus on identifying environmental negotiations for additional data, if the derived from these telomers, and of the fate and transport information, as well testing from voluntary activities, the fluoropolymers and fluoroelastomers as other relevant information to enhance initial ECA, or from a test rule identify made with PFOA or related chemicals, understanding of the sources of PFOA additional data gaps which must be currently in commerce? In what in the environment and the pathways by filled. volumes and at what locations are these which human exposure to PFOA is chemicals manufactured or imported? occurring. The objective of the ECA B. ECA Process and Public Participation How and in what volumes are these process is to conclude one or more in Negotiations chemicals used? What are the benefits of ECAs that will set in place an industry- EPA will provide the public with an these chemicals and products in their sponsored testing program that will opportunity to comment on and specific uses, and what alternatives to address a number of EPA’s current data participate in the development of any these chemicals may be available for needs for PFOA and telomers. EPA ECAs on PFOA and telomers to ensure specific uses? expects that industry will meet the that the views of interested parties are voluntary testing commitments made in taken into account during the ECA B. Exposure Information their letters of intent, as discussed in process. This process is described How are products containing the Unit III.E. Therefore, EPA anticipates generally in this unit, and is more fully chemicals identified in Unit IV.A. used? that the ECA process will focus addressed in 40 CFR part 790. How are these products disposed of? generally on testing issues beyond or Individuals and groups who respond What environmental releases occur at supplemental to those contained in the to this notice by May 16, 2003 and manufacturing and processing facilities industry letters of intent. request treatment as interested parties where these chemicals are used? What will have the status of interested parties. A. Solicitation of Interested Parties data are available on worker exposures All negotiating meetings for the to these chemicals? What data are EPA is soliciting interested parties to development of this ECA will be open available on exposures to the general monitor or participate in negotiations on to the public and minutes of each population? What data are available on ECAs for PFOA and telomers. As meeting will be prepared by EPA and measured levels of these chemicals in discussed in Unit III.E., 3M; AGA placed in the official public docket for humans and the environment, in all Chemicals; Asahi Glass Fluoropolymers this action. The Agency will advise environmental media? What data are USA, Inc.; Clariant GmbH; Daikin interested parties and the public of available on the biodegradation of these America, Inc.; Dyneon LLC; and E.I. meeting dates and make available chemicals, on releases of these duPont de Nemours & Company, have meeting minutes, testing proposals, chemicals from consumer and industrial been pursuing voluntary collective background documents, and other products, and on their breakdown actions to address issues associated with relevant materials exchanged at or during product biodegradation, PFOA and telomers and have been prepared for negotiating meetings. incineration, and other disposal keeping EPA informed of these Where tentative agreement is reached on practices? activities. Any person who desires an acceptable testing program, a draft treatment as an ‘‘interested party’’ ECA will be made available for C. Monitoring and Related Information during the development of the ECAs comment by interested parties and, if EPA specifically requests that any must respond in writing to this notice necessary, EPA will hold a public persons who have in their possession on or before May 16, 2003 following the meeting to discuss any comments that existing human or environmental instructions in Unit I., and must have been received and determine monitoring data indicating or assessing specifically request that they be given whether revisions to the ECA are the presence of PFOA and related ‘‘interested party’’ status. These appropriate. EPA will not reimburse fluorochemicals in humans, in wildlife, interested parties will not incur any costs incurred by non-EPA participants or in any environmental media, obligations by being so designated. in this ECA negotiation process. including studies conducted in other Negotiations will be conducted in one Enforceable consent agreements will countries, provide those data to the or more meetings, all of which will be only be concluded where an agreement Agency in response to the publication of open to the public. EPA will contact all can be obtained, which is satisfactory to this notice to enhance the interested parties who have expressed a the Agency, manufacturers or processors understanding of PFOA presence in the desire to participate in or monitor the who are potential test sponsors, and environment and of the pathways ECA negotiations and advise them of all other interested parties, concerning the leading to exposures. EPA includes in meeting dates. EPA will also notify the need for and scope of testing. In the

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absence of an ECA, EPA reserves the (67 FR 11014, March 11, 2002) (FRL– USEPA, Region III and Region V. right to proceed with rulemaking. 6823–7); (67 FR 72854, December 9, Philadelphia, PA. March 12, 2002. More specifically, EPA will not enter 2002) (FRL–7279–1). 15. West Virginia Department of into an ECA if either the Agency and 3. (AR226–0639) PFOS Presentation Environmental Protection. Final affected manufacturers or processors to CMA. Auer, Charles M., USEPA. Ammonium Perfluorooctanoate (C8) cannot reach an agreement on the Washington, DC. June 19, 2000. Assessment of Toxicity Team (CATT) 4. (AR226–1127) Revision of PFOA provisions of the ECA, or the draft ECA Report. Charleston, WV. August 2002. is considered inadequate by other Hazard Assessment and Next Steps. interested parties who have submitted Memorandum from Charles M. Auer to List of Subjects timely objections to the draft ECA. Oscar Hernandez, Mary Ellen Weber, However, EPA may reject these and Ward Penberthy. USEPA. Environmental protection, Chemicals, objections if the Agency concludes that: Washington, DC. September 27, 2002. Hazardous substances. 1. They are not made in good faith; 5. Section 4(f) of TSCA (15 U.S.C. 2. They are untimely; 2603 (4)). Dated: April 14, 2003. 3. They are not related to the 6. (AR226–0620) Sulfonated Stephen L. Johnson, adequacy of the proposed testing Perfluorochemicals in the Environment: Assistant Administrator for Prevention, program or other features of the ECA Sources, Dispersion, Fate, and Effects. Pesticides and Toxic Substances. that may affect EPA’s ability to fulfill 3M. St. Paul, MN. March 1, 2000. the goals and purposes of TSCA; or 7. Environmental, Health And Safety [FR Doc. 03–9418 Filed 4–14–03; 1:26 pm] 4. They are not accompanied by a Measures Relating to Perfluorooctanoic BILLING CODE 6560–50–S specific explanation of the grounds on Acid and Its Salts (PFOA). Letter from which the draft ECA is considered Dr. Larry Wendling, 3M, to Stephen L. ENVIRONMENTAL PROTECTION objectionable. Johnson, USEPA. 3M. St. Paul, MN. AGENCY EPA will prepare an explanation of March 13, 2003. the basis for each ECA. That document 8. Characterization of Fluorinated will summarize the agreement Metabolites by a Gas Chromatographic- [OPP–2003–0078; FRL–7299–2] (including the needed data Helium Microwave Plasma Detector; development), explain the objectives of The Biotransformation of 1H, 1H, 2H, Kansas State Plan for Certification of the data collection/development 2H-Perfluorodecanol to Applicators of Restricted Use activity, and outline the chemicals’ use Perfluorooctanoate. Hagen, Donald F.; Pesticides; Notice of Availability and exposure characteristics. That Belisle, John; Johnson, James D.; and AGENCY: document, which will also announce Venkateswarlu, P. Analytical Environmental Protection the availability of the final ECA, will be Biochemistry. 118, 336–343 (1981). Agency (EPA). published in the Federal Register. Upon 9. (AR226–1149). Revision 1, ACTION: Notice of intent. the successful completion of an ECA, Biodegradation Screen Study for export notification under TSCA section Telomer-Type Alcohols. Lange, Cleston SUMMARY: The State of Kansas has 12(b) would be required for all C. Pace Analytical Services, submitted to EPA programmatic signatories to the ECA who export or Minneapolis, MN. November 6, 2002. amendments to its State Plan for intend to export the chemicals subject to 10. Mabury, Scott. Annual Report of Certification and Training of the ECA. A separate action would be Activities for Telomer Research Program Applicators of Restricted Use Pesticides. published in the Federal Register Grant to University of Toronto. The proposed amendment establishes following the announcement of the ECA University of Toronto, Toronto, Canada. new requirements for the recertification to apply the export notification September 2002. of pesticide applicators. Notice is requirement to others by adding the 11. (AR226–1136) Revised Draft hereby given of the intention of the ECA chemicals to the list of chemicals Hazard Assessment of Perfluorooctanoic Regional Administrator, Region VII, to subject to testing consent orders at 40 Acid and Its Salts. USEPA, OPPT, Risk approve the revised Plan for the CFR 799.5000. Assessment Division. Washington, DC. Certification of Applicators of Restricted November 4, 2002. VI. References Use Pesticides. EPA is soliciting 12. Voluntary Actions to Evaluate and comments on the proposed These references have been placed in Control Emissions of Ammonium amendments. the official docket that was established Perfluorooctanoate (APFO). Letter from under docket ID number OPPT–2003– Charles D. Allen, Asahi Glass DATES: Comments, identified by docket 0012 for this action as indicated in Unit Fluoropolymers USA, Inc.; Takahiko ID number OPP–2003–0078, must be I.B.2. Reference documents identified Sakanoue, Daikin America, Inc.; James received on or before May 16, 2003. with an Administrative Record number E. Gregory, Dyneon LLC.; and Richard J. (AR226–XXXX) are available in the Angiullo, E.I. duPont de Nemours & ADDRESSES: Comments may be public version of the official docket Company, to Stephen L. Johnson, submitted electronically, by mail, or maintained in the OPPT Docket. Copies USEPA. March 14, 2003. through hand delivery/courier. Follow of these documents may be obtained as 13. Letter of Intent for the Telomer the detailed instructions as provided in described in Unit I.B.2. Research Program from H. Okuno, AGA Unit I. of the SUPPLEMENTARY 1. USEPA. Preliminary Risk Chemicals, Inc.; Hans Ludwig Panke INFORMATION. Assessment of the Developmental and Reinhard Jung, Clariant GmbH; FOR FURTHER INFORMATION CONTACT: John Toxicity Associated with Exposure to Takahiko Sakanoue, Daikin America, T. Tice, Water, Wetlands and Pesticides Perfluorooctanoic Acid (PFOA) and its Inc.; and Stephen H. Korzeniowski, E.I. Division, WWPD-PEST, 100 Centennial Salts. OPPT, Risk Assessment Division. duPont de Nemours & Company, to Mall N., Room 289, Lincoln, NE 68508; Washington, DC. April 10, 2003. Stephen L. Johnson, USEPA. March 14, telephone number: (402) 437–5080; e- 2. Federal Register. (65 FR 62319, 2003. mail address: [email protected]. October 18, 2000) (FRL–6745–5); (67 FR 14. Order on Consent between E.I. 11008; March 11, 2002) (FRL–6823–6); duPont de Nemours & Company and SUPPLEMENTARY INFORMATION:

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