The Environmental Protection Agency (EPA) on Jan. 25 announced a global stewardship program that calls for voluntary withdrawal of use of toxic compound perfluorooctanoic acid (PFOA).

PFOA is the key ingredient used to manufacture Teflon or fluoropolymers, which are used in the manufacture of a wide range of non-stick and stain-resistant surfaces and products.

PFOA, persistent in the environment, has been detected in low levels in wildlife and humans, and animal studies conducted have indicated effects of concern.

Last year, a scientific panel commissioned by the EPA suggested that PFOA or C8 can potentially cause cancer and asked the EPA to take actions on the chemical, which is found in 95 percent of Americans.

"The science is still coming in, but the concern is there so acting now to minimize future releases of PFOA is the right thing to do for our environment and our health," said Susan B. Hazen, acting assistant administrator of EPA's Office of Prevention, Pesticides and Toxic Substances.

"EPA is pleased to provide companies the opportunity to step up to the plate and demonstrate their leadership in protecting our global environment."

In a Jan 25 letter to fluoropolymer and telomer manufacturers inviting them to participate in the program on PFOA and related chemicals, EPA Administrator Stephen L. Johnson indicates that the EPA wants to achieve two goals through the program.

The first goal is to "to commit to achieve, no later than 2010, a 95 % reduction, measured from a year 2000 baseline, in both: facility emissions to all media of PFOA, precursor chemicals that can break down to PFOA, and related higher homologue chemicals, and product content levels of PFOA, precursor chemicals that can break down to PFOA, and related higher homologue chemicals."

The second is "to commit to working toward the elimination of PFOA, PFOA precursors, and related higher homologue chemicals from emissions and products by five years thereafter, or no later than 2015."

DuPont responded quickly to the invitation. In a statement released on Jan 27, the company said it "has committed to virtually eliminate the sources of exposure to PFOA from our manufacturing operations and products by 2015."

Specially, DuPont states its commitment to achieving by 2010 a 95 percent reduction measured from a year 2000 baseline, in both facility emissions and product content levels. It also commits to the "elimination of PFOA, PFOA precursors, and related higher homologue chemicals from emissions and products by five years thereafter, or no later than 2015."

In the meantime, DuPont will continue to use the Teflon(R) brand and support Teflon(R) branded products, which the company believes are safe. It stresses that "cookware made with Teflon(R) non-stick coatings is made from fluoropolymers, not PFOA," suggesting that the material used for cookware is safe.

Other companies invited to the program include 3M/Dyneon, Arkema, Inc., AGC, Chemicals/Asahi Glass, Ciba Specialty Chemicals, Clariant Corporation, Daikin, E.I. DuPont de Nemours and Company, and Solvay Solexis.

Both the EPA and DuPont won praise from the Environmental Working Group, an environmental group that often doses the chemical industry and the federal agency with a lot of evidence-based criticism.


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Most Frequent Asked Questions and Answers (from EPA)


How long has the Agency been looking into PFOA and its potential risks?

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 3M, the manufacturer of PFOS, the company terminated production of these chemicals. Findings on PFOS led EPA to review similar chemicals, including PFOA, starting in 2000, to determine whether they might present concerns similar to those associated with PFOS.

What are the concerns related to PFOA?

PFOA is very persistent in the environment and was being found at very low levels both in the environment and in the blood of the general U.S. population. Studies indicated that PFOA can cause developmental and other adverse effects in laboratory animals. PFOA also appears to remain in the human body for a long time. All of these factors, taken together, prompted the Agency to investigate whether PFOA might pose a risk to human health and the environment at the levels currently being found, or at levels that might be reached in the future as more PFOA continues to be released into the environment.

How are people exposed to PFOA?

EPA does not have a full understanding of how people are exposed to PFOA, which is used an essential processing aid in the manufacture of fluoropolymers, and may also be a breakdown product of other related chemicals, called fluorinated telomers. In April 2003 EPA released a preliminary risk assessment for PFOA, and started a public process to identify and generate additional information to better understand the sources of PFOA and the pathways of human exposure.

What are fluoropolymers and telomers used for?

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. They are employed in hundreds of other uses in almost all industry segments, including the aerospace, automotive, building/construction, chemical processing, electrical and electronics, semiconductor, and textile industries. Telomers are used as surfactants and as surface treatment chemicals in many products, including fire fighting foams; personal care and cleaning products; and oil, stain, grease, and water repellent coatings on carpet, textiles, leather, and paper.

Are there steps that consumers can take to reduce their exposure to PFOA?

At present, there are no steps that EPA recommends that consumers take to reduce exposures to PFOA because the sources of PFOA in the environment and the pathways by which people are exposed are not known. Given the scientific uncertainties, EPA has not yet made a determination as to whether PFOA poses an unreasonable risk to the public. At the present time, EPA does not believe there is any reason for consumers to stop using any consumer or industrial related products that contain PFOA.

What is the status of the agency's on-going process to reduce these scientific uncertainties and to more fully understand the pathways of human exposure and potential risks from PFOA?

EPA identified the need to improve its understanding of the sources and pathways of exposure to PFOA in 2003 and initiated a process to develop needed new date on the issue. This new information will assist the Agency in determining if there are potential risks and what risk management steps may be appropriate. Specifically, EPA is working with industry and other stakeholders to obtain additional monitoring information on PFOA, exposures resulting from incineration or loss from products as they are used over time, and telomer biodegradation as a potential source of PFOA. The Agency is developing formal TSCA Section 4 Enforceable Consent Agreements (ECAs) and Memoranda of Understanding (MOUs) with industry in a public process involving a large number of interested parties, and is cooperating on voluntary research activities.

What is the status of the ECAs?

Two separate ECAs were signed by EPA, Asahi Glass, Clariant Corporation, Daikin America, Inc., DuPont, and Dyneon LLC, and published in the Federal Register on July 8, 2005 for laboratory-scale incineration testing of fluoropolymers and fluorotelomers. These tests will help to determine whether articles made or treated with these chemicals may produce PFOA when they are disposed of in municipal incinerators. More information on the July 2005 ECAs is available here.

Scientists from EPA, the Consumer Product Safety Commission, the Food and Drug Administration, industry and other interested parties are working together to develop protocols for another ECA testing program on fluoropolymer products (including non-stick cookware, membranes for apparel, plumbers' thread sealant tape, and plenum cable) to determine whether these products generate or release PFOA as they age during use.

What is the status of the MOUs?

EPA signed an MOU with 3M and Dyneon LLC on October 25, 2004 for monitoring in the vicinity of a fluoropolymer manufacturing facility in Decatur, AL. The Agency also signed a similar MOU with DuPont on November 3, 2005 concerning monitoring at the Washington Works facility in Parkersburg, WV.

When will the agency begin receiving information from these efforts?

Reports from the 3M/Dyneon monitoring MOU are being submitted quarterly into docket EPA-HQ-OPPT-2004-0112, beginning in January 2005. Quarterly reports on the DuPont MOU will be into docket EPA-HQ-OPPT-2004-0113 in February 2006. Preliminary reports from the incineration testing ECAs will be submitted beginning in 2006 to docket numbers EPA-HQ-OPPT-2003-0071 and EPA-HQ-OPPT-2004-0001. EPA and industry are separately conducting independent fluorinated telomer biodegradation testing to determine whether telomer products may degrade to release PFOA. Some of these studies require a year or more to complete, but preliminary results from some of the industry testing are expected in Summer 2005, and will be placed into the main docket, EPA-HQ-OPPT-2003-0012. Since this investigation began, the Agency has been receiving information on an ongoing basis from the companies that submitted Letters of Intent (LOIs) in March 2003, covering commitments made for data on a range of topics including production volumes, manufacturing processes and releases, chemical uses, and toxicity and pharmacokinetics, among others. This information has been made public to the extent possible through the online docket EPA-HQ-OPPT-2003-0012 and Administrative Record AR-226.

How can I get information from the dockets 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 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 oppt.ncic@epa.gov. Additional information is available on the PFOA Dockets page.

Why did the Agency release a draft risk assessment on PFOA in January 2005?

In order to ensure the most rigorous science is used in the Agency's ongoing evaluation of PFOA, EPA is seeking scientific peer review from an outside panel of scientific experts on the Agency's draft PFOA risk assessment. EPA will use these recommendations as it revises the assessment.

Does this draft assessment provide new conclusions on potential risks?

It is important to note that this draft is preliminary and does not provide any new conclusions regarding potential levels of concern. It does highlight the scientific approaches and critical data that will be used in developing the Agency's revised PFOA risk assessment.

What steps is the Agency taking to ensure the risk assessment contains rigorous science?

The Agency is seeking formal peer review by the Agency's Science Advisory Board at this point in the process to ensure that the approaches used in the assessment are scientifically sound before we proceed to revise the assessment. This draft is preliminary and does not provide conclusions regarding potential levels of concern.

Why did the Agency revise the preliminary draft and does it provide the public with better information about any potential risks?

The preliminary draft risk assessment, released in April 2003, focused only on developmental toxicity and identified considerable uncertainty in the assessment. Since that time, new data have become available that has allowed the Agency to refine our understanding of the potential development toxicity risks and the Agency has broadened the analysis to consider the full range of potential human health effects, including carcinogenicity and systemic toxicity.

What new approaches are included in the draft risk assessment?

Several new approaches are presented in the draft risk assessment, including an analysis of how PFOA can cause liver tumors in rats and its relevance for human health and pharmacokinetic modeling to estimate PFOA blood serum levels in the rat toxicology studies. In addition, the Agency is seeking advice on the use in of approaches comparing PFOA levels in blood serum from experimental animals with measured human blood serum values. This is a novel approach which differs from the more typical approaches which involve a comparison of administered dose for the animals with estimated human exposure.

When will the Agency complete the revised PFOA risk assessment?

We do not anticipate receiving the final report and recommendations from the Science Advisory Board until early 2006. In addition, the Agency continues to consider new information that is being developed so it is not possible at the present time to give a precise estimate for completing a revised risk assessment.

Are there other activities underway concerning PFOA and telomers?

The Centers for Disease Control and Prevention (CDC) will be including PFOS, PFOA, and several other fluorinated chemicals in upcoming National Reports on Human Exposure to Environmental Chemicals. More information on these Reports can be found at http://www.cdc.gov/exposurereport.

The National Toxicology Program will be conducting a class study on multiple perfluorosulfonates and carboxylic acids, including PFOA and telomer derivatives, to better understand the toxicity of these chemicals and their tendency to remain in the human body for a long time. Information on the NTP and its studies can be found at http://ntp.niehs.nih.gov/.

Has the Agency brought an enforcement case against DuPont on PFOA?

EPA brought civil administrative actions against DuPont in 2004 and 2005 for failing to report information concerning PFOA to the Agency as required by section 8(e) of the Toxic Substances Control Act. On December 14, 2005, EPA forwarded to the Environmental Appeals Board (Board) a settlement with DuPont for the largest civil administrative penalty EPA has ever obtained under any federal environmental statute. Information on this case and the settlement can be found on the Civil Enforcement website.

What is the 2010/15 PFOA Stewardship Program, and how does it relate to all the other PFOA activities?

On Wednesday, January 25, 2006, Administrator Johnson invited fluoropolymer and telomer manufacturers doing business in the United States to participate in a global stewardship program on PFOA and related chemicals. Participating companies will commit to reducing PFOA from emissions and product content by 95 percent no later than 2010, and to work toward eliminating PFOA from emissions and product content no later than 2015. Company commitments are requested by March 1, 2006, and companies that participate will report their annual progress on a company-wide basis for both their U.S. and global operations. Commitment to the program is in addition to and does not replace existing commitments to enforceable consent agreements or memoranda of understanding.

More information, including the Administrator's letter, is available on the 2010/15 PFOA Stewardship Program page.

Source: EPA

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