The Environmental Protection Agency launched April 14 an unusual, expedited review of a chemical used to make fluoropolymers. The agency said recent studies raise concerns both that it could be toxic and that the general public is mysteriously exposed at low levels.
As part of the EPA review of perfluorooctanoic acid, which is used as a processing aide in making fluoropolymers, the Fluoropolymers Manufacturers Group and other industry associations said they will work with EPA to reduce emissions and do more research.
Industry officials said they consider PFOA safe. EPA officials said they are not recommending at this point that the chemical be restricted, but said there's much they need to know before they can make a decision either way.
An EPA study, for example, noted that animal tests show that exposure levels in children and women of childbearing age might be outside the margins of safety that regulators demand.
The chemical has not been regulated widely by EPA, and definitive knowledge is elusive - those exposure levels in women and children could be well within safe levels, for example. EPA officials said they do not understand fully how people are exposed to PFOA, whether from manufacturing emissions or the breakdown of telomers, small fluorinated polymers, in the environment.
``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 Johnson, assistant administrator of the EPA Office of Prevention, Pesticides, and Toxic Substances.
The various industry groups, including FMG, expect to enter into binding, enforceable consent agreements with EPA about steps they will take.
FMG, for example, said in an April 14 letter to EPA that it will cut PFOA emissions by 50 percent by 2006, from 2002 levels. Fluoropolymer maker DuPont Co. said it welcomes government regulation, and FMG officials praised the EPA involvement.
``This has been a good process, with an outcome that will assure continued protection of human health and the environment without disrupting the supply of essential materials and causing undue adverse impact on an industry that is of vital importance to the U.S. economy,'' said Don Duncan, president of the Society of the Plastics Industry Inc. in Washington. FMG is a business unit of SPI.
About 95 percent of fluoropolymers are used in critical applications in industries like defense, aerospace and telecommunications, while a small amount is used in nonstick cookware like DuPont's Teflon. EPA said alternatives do not exist to PFOA in many applications.
PFOA, which does not occur naturally, is key to making fluoropolymers but it does not become part of the polymer. That leaves regulators and scientists guessing about how the general public is exposed. The wide exposure suggests to EPA that there are other sources beyond manufacturing plants. Some research indicates PFOA forms during the degradation of telomers, which are used in fire-fighting foams and water-repellent coatings, EPA said.
EPA also is investigating allegations from the Washington-based Environmental Working Group that fluoropolymer manufacturer DuPont broke the law by withholding PFOA studies from EPA.
In one case, EWG said, DuPont did not disclose test results that showed PFOA in the umbilical cord blood of two women who worked in the fluoropolymer plant in Parkersburg, W.Va. The company also failed to disclose studies of PFOA contamination in drinking water around Parkersburg, EWG said.
Wilmington, Del.-based DuPont said in a statement that the tests did not have to be reported because federal law requires reporting information that ``reasonably supports the conclusion'' that a chemical ``presents a substantial risk of injury to health.''
DuPont said that there is no evidence that demonstrates that PFOA harms human health, and that the data it had did not relate exposure to human health and therefore did not require disclosure.
There were some early red flags with PFOA, however. DuPont said it was told in 1981 by 3M Co., which made PFOA at the time, that preliminary tests showed PFOA might cause birth defects in lab animals.
DuPont said it immediately withdrew women of childbearing age from possible exposure to PFOA as a precaution, but further testing showed that the initial 3M test was not valid.
Women were allowed to return to those parts of the plant in 1982, and employees were fully notified, the company said. One of the women monitored had a child with a birth defect, but ``there is no indication it was caused by PFOA,'' DuPont said.
EWG said in its petition that two of the women had babies with birth defects.
Some of the documentation in the EWG petition has become public as a result of a class-action lawsuit in West Virginia contending that PFOA harms human health. But DuPont said its use of PFOA for 50 years has not harmed people and said it was not trying to hide information.
SPI's Duncan spent more than 30 years with DuPont before heading SPI in 2000. He joined DuPont in 1963 at the Parkersburg plant, and held senior positions with many DuPont units, including the fluoro-products unit, along with the firm's engineering plastics, industrial polymers, packaging and elastomers units.
He said he did not have any involvement with the PFOA studies and he declined to say when he worked at the fluoro-products unit because he said it was not relevant.