EPA Scientific Advisory Board Unanimously Approves Recommendation Labeling PFOA a Likely CarcinogenicFeb 17, 2006 | Newsinferno News Staff
After years of inaction and equivocating, the Environmental Protection Agency (EPA) now appears to be committed to putting an end to the use of PFOA (also known as C-8) in the manufacture of Teflon and other products.
Back-to-back actions by the agency, while not specifically ordering any outright ban on the chemical, ensure its demise as a component of the manufacturing process used to produce a variety of non-stick and stain-resistant products.
Although it appeared some recent progress was being made with respect to the possibility that PFOA would eventually be banned in the United States, there was no real indication of when the drive to attain that ban would gain enough momentum and government backing to force the issue to a final determination.
Back in December, in the largest settlement involving a civil administrative penalty under any federal environmental statute in agency history, the Environmental Protection Agency (EPA) announced that DuPont agreed to pay $10.25 million in fines and $6.25 to fund environmental projects to settle allegations that the company withheld information about the dangers of the toxic chemical, PFOA.
The settlement resulted from the EPA’s action against DuPont, for allegedly withholding information about the potential health and environmental risks posed by perfluorooctanoic acid, or PFOA (C-8), under provisions of both the Toxic Substances Control Act and the Resource Conservation and Recovery Act.
The EPA charged that the company knowingly withheld information for more than 20 years about the health effects of PFOA and about the pollution of ground water supplies around DuPont’s Washington Works plant near Parkersburg, West Virginia.
As we have previously reported, for the past two years, there has been a growing concern over the safety of the manmade chemical known as C-8 or PFOA which can be found in everything from bread to birds, green beans to ground beef, dolphins to drinking water, and in the blood of up to 96% of the population of the United States.
The acid is used to manufacture Teflon coating for cookware and hundreds of other products like telephone cables, carpets, clothing, computer chips, chemical piping, and automobile fuel systems. Teflon currently nets DuPont a reported $200 million in profit a year.
Because there are no known “natural” sources of C-8, scientists are curious as to how the chemical enters the environment. C-8 has also contaminated the groundwater in areas where Teflon is manufactured.
DuPont, which also pioneered the development of PFOA and continues to dominate its use, claims that the chemical is harmless to humans. It also disputes that C-8 is released during normal cooking (as opposed to overheating).
Others are not so sure that either assertion is true. Studies have concluded that C-8 is one of several toxic gases released by Teflon when it is heated to temperatures which, at their low end, are only slightly above normal cooking temperatures.
C-8 has been shown to cause tumors in rats and fumes from Teflon coated cookware can cause what is known as “polymer fume fever,” a condition which has been shown to kill birds even at low temperatures but which DuPont claims is harmless to humans if the cookware is used at a temperature of up to 500„aF. When Teflon is overheated (above 700 degress F), fatal cases of polymer fume fever in humans have occurred (at 842 degrees F).
Last August, DuPont agreed to pay up to $343 million in settlement of a class action arising out of the contamination of drinking water in Ohio and West Virginia linked to its plant near Parkersburg, West Virginia.
Of that amount, most of the $107 million to be paid for damages to the water supply of some 50,000 people living near the plant will be used to fund a detailed scientific review and a landmark community health study with respect to the dangers posed by C-8 in the six Ohio and West Virginia water districts covered by the settlement.
Up to another $235 million is to be set aside for future medical monitoring if the studies find C-8 can make people sick.
So far, over 43,000 individuals have signed up for the health study with more than 17,000 having been tested since August. There is a waiting list of about 26,000 people. Eventually, up to 60,000 people are expected to take part in the study. Each person who completes the screening will be paid $400.
Beginning this year, a court-appointed panel of three epidemiologists will begin reviewing the results of the screening project. Although DuPont continued to claim that there is no confirmed danger posed by C-8, the company announced that it planned to dramatically decrease the use of PFOA in Teflon coatings by the end of 2006.
Earlier in 2005, however, the EPA stated that tests on laboratory animals linked PFOA to liver, pancreatic, and testicular cancer, reduced birth weight, birth defects, and immune suppression.
The agency also found that elevated cholesterol and triglycerides were a risk of exposure to C-8. As a result, the EPA stated that low-level exposure to PFOA could pose a “potential risk of developmental and other adverse effects” in humans.
The EPA had released a draft assessment of the chemical used in the production of Teflon which, based on animal studies, found “suggestive evidence” that the substance may be a human carcinogen.
In May 2005, the Justice Department issued grand jury subpoenas seeking documents from DuPont with respect to PFOA and related chemical compounds. The suspicion was that DuPont withheld critical information concerning possible health risks posed by PFOA.
A 1961 internal document indicated that DuPont scientists had already warned company executives to avoid human contact with PFOA. DuPont faced more than $300 million in fines if it was found guilty of withholding such information.
In August 2005, a draft report released by an independent EPA scientific advisory board which reviewed the earlier EPA assessment and which will now be submitted to the EPA, concluded that PFOA (C-8) is “likely” to be a human carcinogen and, as a result, the EPA should conduct cancer risk assessments for a variety of tumors found in rats and mice exposed to it.
Another startling revelation was reported in the Charleston Gazette on July 10, 2005. According to an April 2004 sworn statement by Dr. Bruce Karrh, DuPont’s former medical director, the company found similar birth defects in two of eight children born to women who worked at the Parkersburg chemical plant 25 years ago.
The Charleston Gazette also reported that: “A DuPont researcher said the number was ‘significantly greater’ than the expected rate of birth defects in the general population. In April 1981, the researcher proposed that DuPont do a detailed study to determine if exposure to the toxic chemical C-8 was to blame. Three months later, DuPont officials dropped the study, a former top corporate doctor has testified. Dupont officials also decided not to report its preliminary findings to federal regulators, according to the testimony, obtained under the Freedom of Information Act. ‘To my knowledge, it was never reported to EPA, and, to my knowledge, I didn’t ask anybody whether it was reported,’ Karrh said of the birth defects data.”
The study will look for a number of potential links involving C-8; however, cancer and heart disease are of the greatest concern. Those results may take up to four years to report. Each sample taken from the test subjects is tested for the presence of C-8 and for organ function.
While the EPA declared that the settlement "sends a strong message that companies are responsible for promptly giving EPA risk information associated with their chemicals;" DuPont has not admitted liability and continues to take the position that “there (are) no human health effects that we know about that are caused by PFOA, We've seen nothing."
Thus, with strong evidence against it and a downside risk of over $300 million in civil penalties for failing to report the substantial risks posed by PFOA, DuPont made the prudent business decision of settling the entire EPA case for a total of $16.5 million. DuPont’s general counsel summed up the company’s position on the settlement by stating: "Frankly, we could have litigated this thing for several years. We wanted to get this thing behind us so we could move forward."
A federal criminal investigation of DuPont’s actions with respect to PFOA has also been ongoing. Then only last month, in an unexpected move, the EPA requested DuPont and seven other chemical companies to stop using PFOA in their manufacturing processes.
According to the EPA, the program, which at present would be voluntary, would, if fully complied with, by all of the companies and their overseas affiliates lead to a 95% reduction in PFOA use by 2010 and their total elimination by 2015.
DuPont immediately issued a pledge to join the program, stating it had already reduced its PFOA manufacturing emissions by 94% and had developed new technologies that could reduce PFOA content in products by more than 97%.
The seven other chemical companies that are expected to sign on to the program as well are 3M/Dyneon, Arkema, Asahi, Ciba, Clariant, Daikin, and Solvay Solexis.
Now, the draft report too has been acted upon. The scientific advisors on the EPA’s Scientific Advisory Board (SAB) have unanimously approved the recommendation that PFOA be considered a “likely carcinogen.”
Although the SAB members agreed that their findings should not be considered the final word on the PFOA matter, and that it should be updated when and if additional data becomes available, the unanimous vote coupled with the direction in which research studies have been going, leaves little doubt that PFOA should be regarded as a dangerous toxic substance.
The EPA is now free to accept or reject the SAB’s recommendation. According to Oscar Hernandez, director of the EPA’s risk assessment division of the Office of Pollution Prevention and Toxics, the report “as well as all new information that becomes available, to formulate the next steps in our continuing assessment of these chemicals."
(Sources: Environmental Protection Agency and Newsinferno.com Archives)