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Teflon Lawsuit Attorney: Teflon PFOA (Perfluorooctanoic Acid) Frequently Asked Questions
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 is concluding a similar MOU with DuPont, which we anticipate signing in July 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 OPPT-2004-0112, beginning in January 2005. Preliminary reports from the incineration testing ECAs will be submitted beginning in late 2005 to docket numbers OPPT-2003-0071 and 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, 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 OPPT-2003-0012 and Administrative Record AR-226.
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 comments from the SAB reviewers until Summer 2005. 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 administrative actions against DuPont for failing to report information concerning PFOA to the Agency as required by section 8(e) of the Toxic Substances Control Act. Information concerning the complaints can be found on the EPA Civil Enforcement website.
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