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EPA Intensifies Scientific Investigation of a Chemical Processing Aid
Release Date: 04/14/2003
Contact Information:
Contact: David Deegan, 202-564-7839/deegan.dave@epa.gov
(04/14/03) Today EPA is releasing a preliminary risk assessment for the chemical PFOA and is encouraging the public and other interested parties to participate in identifying and generating additional information that will allow the Agency to further develop its risk assessment. PFOA, also known as perfluorooctanoic acid, is used as a processing aid in the manufacture of a wide variety of consumer and industrial products, and may also be formed during the environmental breakdown of related chemicals. Studies recently evaluated by the Agency have raised a number of potential toxicity concerns, and when combined with information that the general U.S. population may be exposed to very low levels of PFOA, has led the Agency to conclude that additional scientific information is needed to determine if new regulatory actions are necessary.
“To ensure consumers are protected from any potential risks, the Agency will be conducting its most extensive scientific assessment ever undertaken on this type of chemical,” said Stephen L. Johnson, Assistant Administrator of EPA’s Office of Prevention, Pesticides, and Toxic Substances. “Today’s announcement puts in place rigorous regulatory and scientific steps that will lead to a better understanding of PFOA. This priority scientific review will guarantee that any future regulatory action on PFOA is protective of public health and supported by the best scientific information.”
To initiate this process, the Agency is releasing its preliminary risk assessment on PFOA for public review. A public docket has been established so interested parties can review the scientific information available to the Agency. Similarly, through public meetings, the Agency is inviting participation in the development of enforceable consent agreements, which will be used to direct the generation of new scientific information critical to understanding the sources and pathways of potential exposures to PFOA. By using enforceable consent agreements, the generation of new data can be accelerated so the data is available quickly. Following receipt of additional scientific information, EPA expects to develop a more comprehensive risk assessment that the incorporates new information. The Agency then plans to seek additional public comments and independent peer review from the Agency’s Science Advisory Board later this year.
The Agency is interested in collecting additional information because a new laboratory studies recently evaluated by the Agency shows that PFOA may cause developmental toxicity and other health effects. Further, the available data indicate that the general U.S. population may be exposed to PFOA at very low levels. The potential sources and exposure pathways of PFOA are not well understood at this time. It may be released during manufacturing or processing, and it may also be formed during the environmental breakdown of certain other fluorinated compounds known as telomers. (Telomers are small fluorinated polymers.) PFOA may also have been a contaminant in certain other fluorinated products that were discontinued by the end of 2002.
Because there remains considerable scientific uncertainty regarding the potential risks from PFOA, it is important to develop additional data to determine if subsequent steps are necessary to protect public health. These data include use and production volume data, information on chemical and product degradation, and additional monitoring of PFOA levels in the environment. The additional data will be used to reduce the scientific uncertainties in the risk assessment, to better understand the potential sources in the environment, and to identify potential exposure pathways.
Given these considerable scientific uncertainties, EPA has not made a determination as to whether PFOA poses an unreasonable risk to the public. This determination will be better informed as new exposure data are factored into the risk assessment. EPA does not believe there is any reason for consumers to stop using any consumer or industrial related products.
As a positive step, companies that manufacture and use PFOA, as well as companies that manufacture telomers, are taking voluntary product stewardship steps, as described in Letters of Intent submitted to the Agency. These letters are available in the public docket. For example, 3M will not resume the manufacture of PFOA, and they will continue medical monitoring efforts for workers and continue monitoring groundwater, surface water, and other environmental media and provide reports to EPA. The members of the Fluoropolymer Manufacturers Group have committed to reduce emissions, to study their products to determine whether they may be a source of PFOA, and to take steps to reduce exposures to workers and the environment. The members of the Telomer Research Program have committed to evaluating products sold in the U.S. to determine whether they contribute to significant human or environmental exposure to PFOA.
By way of background, PFOA is used as an essential processing aid in the manufacture of fluoropolymers. Fluoropolymers are used in a wide variety of consumer and industrial applications, including non-stick surfaces on cookware, but finished products are not expected to contain PFOA. PFOA may also be a degradation product of small polymers called telomers, which are used in a range of commercial products including fire fighting foams, as well as soil, stain and grease resistant coatings on carpets, textiles, paper, and leather.
For further information on EPA preliminary risk assessment of PFOA, including the Federal Register notice, Fact Sheet and Questions & Answers, please visit https://www.epa.gov/oppt/ .
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