- 2010/15 PFOA Stewardship Program
- Existing Chemicals Action Plan for Long-Chain Perfluorinated Chemicals (LPFCs)
- Provisional Health Advisories for PFOA and PFOS
- Looking for Alternatives
- Enforceable Consent Agreement (ECA) Process
- Enforcement Actions
- Related PFAS Compounds
- Efforts Proving Successful
- Information on Accessing the Docket and the Administrative Record
Perfluorooctanoic acid (PFOA) is a synthetic (man-made) chemical that does not occur naturally in the environment. PFOA is sometimes called "C8." Companies use PFOA to make fluoropolymers, substances with special properties that have hundreds of important manufacturing and industrial applications. Fluoropolymers impart valuable properties, including fire resistance and oil, stain, grease, and water repellency. They are used to provide non-stick surfaces on cookware and waterproof, breathable membranes for clothing, and are used in many industry segments, including the aerospace, automotive, building/construction, chemical processing, electronics, semiconductors, and textile industries.
PFOA can also be produced by the breakdown of some fluorinated telomers, substances that are used in surface treatment products to impart soil, stain, grease, and water resistance. Some telomers are also used as high performance surfactants in products that must flow evenly, such as paints, coatings, and cleaning products, fire-fighting foams for use on liquid fuel fires, or the engineering coatings used in semiconductor manufacture.
However, consumer products made with fluoropolymers and fluorinated telomers, including Teflon® and other trademark products, are not PFOA. Rather, some of them may contain trace amounts of PFOA and other related perfluorinated chemicals as impurities. The information that EPA has available does not indicate that the routine use of consumer products poses a concern. At present, there are no steps that EPA recommends that consumers take to reduce exposures to PFOA.
In the late 1990's, EPA received information indicating that perfluorooctyl sulfonates (PFOS) were widespread in the blood of the general population and presented concerns for persistence, bioaccumulation and toxicity. Following discussions between EPA and the 3M, the manufacturer of PFOS, the company terminated production of these chemicals.
Findings on PFOS led EPA to review similar chemicals to determine whether they might present similar concerns. The agency began investigating PFOA in 1990s and found that it, too, is very persistent in the environment, is found at very low levels both in the environment and in the blood of the general U.S. population, and causes developmental and other adverse effects in laboratory animals.
As described below, EPA has taken steps to further investigate PFOA and related chemicals as well as to reduce their emissions and use in products. However, given the scientific uncertainties, EPA has not yet made a determination as to whether PFOA poses an unreasonable risk to the public, and there are no steps that EPA recommends that consumers take to reduce exposures to PFOA.
2010/15 PFOA Stewardship Program
In 2006, EPA and the eight major companies in the industry launched the PFOA Stewardship Program, in which companies committed to reduce global facility emissions and product content of PFOA and related chemicals by 95 percent by 2010 and to work toward eliminating emissions and product content by 2015.
Existing Chemicals Action Plan for Long-Chain Perfluorinated Chemicals (LCPFCs):
EPA remains concerned about LCPFCs being produced by companies that are not participating in the stewardship program and intends to take action to address those concerns. On December 30, 2009, EPA posted four action plans, including an action plan on long-chain perfluorinated chemicals (LPFCs). The LCPFCs action plan outlines actions that would further reduce exposure to LCPFCs by addressing their use in products from sources other than the eight companies participating in the stewardship program. As these actions begin, there will be opportunities for public and stakeholder comment and involvement.
Provisional Health Advisories for PFOA and PFOS
On January 9, 2009, EPA's Office of Water (OW) developed Provisional Health Advisories (PHA) for PFOA and PFOS to protect against potential risk from exposure to these chemicals through drinking water. Provisional Health Advisories serve as informal technical guidance to assist Federal, State and local officials in response to an urgent or rapidly developing drinking water contamination. They reflect reasonable, health-based hazard concentrations above which action should be taken to reduce exposure to these contaminants in drinking water. The PHA values are 0.4 µg/L for PFOA and 0.2 µg/L for PFOS. These values may be used to assess contamination and exposure at other sites. Provisional Health Advisories are not to be construed as legally enforceable federal standards and are subject to change as new information becomes available. Read more information on PFOA and PFOS Provisional Health Advisories here.
Looking for Alternatives
EPA is reviewing substitutes for PFOA, PFOS, and other long-chain perfluorinated substances as part of its review process for new chemicals under the Toxic Substances Control Act (TSCA) New Chemicals Program (NCP).
Through end of 2008, over 150 alternatives of various types have been received and reviewed by EPA. EPA reviews the new substances against the range of toxicity, fate and bioaccumulation issues that have caused past concerns with perfluorinated substances, as well as any issues that may be raised by new chemistries.
Enforceable Consent Agreement (ECA) Process
EPA summarized its concerns and identified data gaps and uncertainties about PFOA in the April 16, 2003, Federal Register notice. Beginning in 2003, EPA negotiated with multiple parties to produce missing information on PFOA through enforceable consent agreements, memoranda of understanding, and voluntary commitments.
In 2004, EPA's Office of Enforcement and Compliance Assurance (OECA) took administrative action against DuPont, and filed two complaints under the Toxic Substances Control Act (TSCA) and the Resource Conservation and Recovery Act (RCRA). DuPont's violations consisted of multiple failures to report information to EPA about substantial risk of injury to human health or the environment from PFOA during a period beginning in June of 1981 through March of 2001. Section 8(e) of the TSCA requires U.S. chemical manufacturers, importers, processors and distributors to notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. EPA alleged that DuPont did not submit to the Agency information the company had obtained regarding PFOA. Read more information on EPA's action against DuPont.
In 2005, DuPont paid $10.25 million for violating federal environmental statutes, which is the largest civil administrative penalty EPA has ever obtained. The settlement resolves DuPont's violations related to PFOA under TSCA and RCRA, which includes the eight violations alleged in the Agency's final complaint against DuPont in 2004. The settlement package required DuPont to pay $10.25 million in civil penalties and perform Supplemental Environmental Projects (SEPs) worth $6.25 million. Read more about EPA's Consent Agreement with DuPont (PDF). (118 pp., 3.41 MB, About PDF)
Related PFAS Compounds
Studies have found other related perfluorinated compounds, including perfluoroalkyl sulfonates (PFAS), in very small amounts in the blood of the general human population as well as wildlife. Although most of the health and environmental studies have focused primarily on PFOS, analysis of the structure of the compounds indicates that the results of those studies may be applied to a larger category of PFAS chemicals. EPA believes that the chemical similarity between PFOS and PFAS raises the likelihood that health and environmental concerns are similarly present for PFAS compounds. Following the voluntary phaseout of PFOS by the principal worldwide manufacturer, EPA took prompt regulatory actions in 2002 and 2007 under the TSCA to limit any future manufacture or importation of 271 PFAS chemicals, essentially encompassing all PFAS chemicals on the U.S. market.
EPA Efforts Proving Successful
The success of EPA's voluntary and regulatory efforts are demonstrated in a U.S. Centers for Disease Control study published in 2007 that reported significant reductions in human blood concentrations of PFOS and PFOA, approximately 32 percent and 25 percent respectively, in samples collected 2003-2004 from levels found in samples collected 1999-2000. The report concluded that these reductions were most likely related to changes brought about by EPA efforts on these chemicals and other related efforts by government and industry.
Information on Accessing the Docket and the Administrative Record
All of the "EPA-HQ-OPPT" dockets are available on the Federal Dockets website, www.regulations.gov. Use the "Advanced Search" feature and search on the complete docket number. Please note that the www.regulations.gov website works properly only in Internet Explorer, and that you must disable popup blockers in order to be able to access documents on the site. Administrative Record AR-226 is not currently available online, but copies can be requested on CD-ROM from the EPA Docket Office by calling 202-566-0280 or sending an email request to firstname.lastname@example.org.
EPA has established the following public dockets for the various activities related to PFOA:
- PFOA enforceable consent agreement (ECA) process docket ID number EPA-HQ-OPPT-2003-0012
- Fluoropolymer incineration ECA docket ID number EPA-HQ-OPPT-2003-0071
- Fluorotelomer incineration ECA docket ID number EPA-HQ-OPPT-2004-0001
- 3M PFOA monitoring Memorandum of Understanding (MOU) docket ID number EPA-HQ-OPPT-2004-0112
- DuPont PFOA monitoring MOU docket ID number EPA-HQ-OPPT-2004-0113
- PFOA Stewardship Program docket ID number EPA-HQ-OPPT-2006-0621
- PFOS Significant New Use Rules (SNURs) Docket ID number EPA-HQ-OPPT-2002-0043
- PFAS Significant New Use Rules (SNURs) Docket ID number EPA-HQ-OPPT-2005-0015
- Long-Chain PFCs Docket ID number EPA-HQ- OPPT-2010-0145