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Enforceable Consent Agreement (ECA) Process
To Generate Additional Information

EPA began a public process based on legally enforceable consent agreements to identify and generate additional information to strengthen the PFOA draft risk assessment with a Federal Register Notice dated April 14, 2003.

In response, in March of 2003, three different letters of intent (LOIs) (PDF) (65pp 2431K) About PDF were submitted by the industry:

EPA also invited interested parties to monitor or participate in negotiations on one or more ECA. The first public meeting took place on June 6, 2003, and the last public meeting took place on February 9, 2005. The PFOA ECA process concluded on November 16, 2006. No further meetings are scheduled.

All materials used and generated at the PFOA ECA development meetings, including meeting agendas, attendance lists, meeting handouts, meeting presentations, meeting summaries, and workgroup products are available in docket EPA-HQ-OPPT-2003-0012.

Overview of ECA

An ECA is a negotiated agreement among EPA, industry, and interested parties that requires certain signing parties to generate data and submit those data to EPA on a specified schedule. Test rules can take few years to complete, while typical ECAs can often be concluded in less than a year. ECAs that require new test protocols or adapted test methods can take longer to negotiate than standard ECAs. ECAs are enforceable, meaning that EPA can compel the submission of information agreed to under the ECA. Because they are negotiated in public, all parties who are interested in the data have the opportunity to participate.

Fluoropolymer Incineration ECA

PFOA is used in the manufacture of fluoropolymers. Fluoropolymers are used in a wide variety of industrial and consumer products, including non-stick cookware, chemical and fire-resistant cables and tubing, and waterproof, breathable clothing. The ECA incineration testing of fluoropolymers will help determine whether the chemicals used in these items may break down to release PFOA if they are disposed of in municipal incinerators.

On July 8, 2005, the Agency published a Federal Register Notice on an ECA for laboratory-scale incineration testing on fluoropolymers. The ECA will produce data that will assist the Agency in determining whether the end-of-life incineration of fluoropolymer products that may be a source of PFOA in the environment.

The ECA testing will be performed by the companies that signed the agreements with the Agency. The terms of the agreements were negotiated in public meetings among EPA, industry, and other registered interested parties participating in the PFOA ECA process, including the Food and Drug Administration, the Consumer Product Safety Commission, local water utilities, and public health and environmental groups.

The principal test sponsor for the fluoropolymer incineration testing ECA is the FMG. The companies within FMG that signed the ECA and committed to the testing are AGC Chemicals Americas, Inc., Daikin America, Inc., Dyneon, LLC, and E.I. DuPont de Nemours and Company. The sponsors and signatory companies pay for the testing. The laboratory hired to conduct the testing must comply with the test standards specified in the ECA and conduct the testing in accordance with the EPA Good Laboratory Practice Standards (GLPS) found at 40 CFR part 792.

All data generated under that testing program is available on the EPA's electronic docket website in docket EPA-HQ-OPPT-2003-0071.

Fluorotelomer Incineration ECA

PFOA may also be a breakdown product of some fluorotelomers. Fluorotelomers are used as surface application treatments on carpets, textiles, paper, leather, and construction materials to provide water, stain, grease, and soil resistance properties, and may be used as surfactants in cleaning and coating products. The ECA incineration testing of fluorotelomers will help determine whether the chemicals used in these items may break down to release PFOA if they are disposed of in municipal incinerators.

On July 8, 2005, the Agency published a Federal Register Notice on an ECA for laboratory-scale incineration testing on fluorotelomers. This ECA will produce data that will assist the Agency in determining whether the end-of-life incineration of fluorotelomer-treated products may be a source of PFOA in the environment.

The ECA testing will be performed by the companies that signed the agreements with the Agency. The terms of the agreements were negotiated in public meetings among EPA, industry, and other registered Interested Parties participating in the PFOA ECA process, including the Food and Drug Administration, the Consumer Product Safety Commission, local water utilities, and public health and environmental groups.

The principal test sponsor for the fluorotelomer incineration ECA is the TRP. The TRP companies that signed the ECA and committed to the testing are AGC Chemicals Americas, Inc., Clariant GmbH, Daikin America, Inc., and E.I. DuPont de Nemours and Company. The sponsors and signatory companies pay for the testing. The laboratory hired to conduct the testing must comply with the test standards specified in the ECA and conduct the testing in accordance with the EPA Good Laboratory Practice Standards (GLPS) found at 40 CFR part 792.

All data generated under that testing program is available on the EPA's electronic docket website in docket EPA-HQ-OPPT-2004-0001. The docket also contains the Final Report for Fluoropolymer Incineration ECA.

Memoranda of Understanding (MOUs)

An MOU is a publicly negotiated agreement among EPA, industry, and interested parties that requires certain signing parties to generate data and submit those data to EPA on a specified schedule. It is very similar to the ECA except for the fact that it is non-enforceable.

These MOUs are expected to characterize potential releases from manufacturing facilities to evaluate the potential presence of PFOA and PFOA precursors in air, water, soils, sediments, and biota.

EPA signed an MOU with 3M and Dyneon LLC on October 25, 2004 for monitoring in the vicinity of a fluoropolymer manufacture facility in Decatur, Alabama. All information relevant to this MOU can be found in Docket OPPT-2004-0112.

EPA also signed on MOU with DuPont on August 2005, concerning monitoring at the Washington Works facility in Parkersburg, WV. All information relevant to this MOU can be found in Docket OPPT-2004-0113.

Aged Articles of Commerce Testing

Generation testing ECAs were expected to determine potential presence of PFOA emitted from fluoropolymer-treated products and articles as they age during use. EPA and the FMG spent almost two years working towards developing new methods to find whether PFOA is generated when fluoropolymers, such as nonstick coatings for cookware and stain and grease repellant coatings, are heated to temperatures near their melting point. In 2006, EPA and the FMG ended their discussions on aged articles of commerce testing under the terms of the ECA.

The FMG and EPA's National Risk Management Research Laboratory (NRMRL) will develop testing protocols for aged article testing to find whether consumer articles are a source of human exposure to PFOA, which is one part of a wider effort to understand and reduce sources and pathways by which the persistent substance has become widespread in the environment. Read more information on ORD's AAOC testing here (PDF) (50pp, KB).

Biodegradation Testing

The parties were unable to reach an ECA on conducting fluorotelomer biodegradation testing under the terms of the ECA, but industry and Office of Research and Development's (ORD) National Exposure Research Laboratory (NERL) and NRMRL have embarked on separate, independent testing programs to determine whether the telomer polymer backbone may break down to produce PFOA. NERL has developed methods for detecting the presence of PFOA in soils, and NRMRL has developed methods for detecting the presence of PFOA in wastewater systems.

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