PFOA 2005
July 10, 2005. DuPont proposed, dropped ’81 study of C8, birth defects
Ken Ward Jr. The Charleston Gazette (West Virginia).

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July 10, 2005

The Charleston Gazette (West Virginia)

DuPont proposed, dropped ’81 study of C8, birth defects

By Ken Ward Jr.
Staff writer

More than 20 years ago, the DuPont Co. found similar birth defects in two of eight children born to women who worked at the company’s Parkersburg chemical plant.

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 C8 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.
Dr. Bruce Karrh, DuPont’s former medical director, revealed the company’s actions in a sworn statement in April 2004.

“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.

Karrh was questioned for two days by lawyers for Wood County residents who sued DuPont over the contamination of their drinking water with C8.

C8 is another name for ammonium perfluorooctanoate, or PFOA. DuPont has used the chemical since 1951 at its Washington Works plant south of Parkersburg to make Teflon and similar products.

Since that time, C8 — and DuPont’s emissions of it — essentially have been unregulated by state and federal agencies.

An EPA science advisory panel has urged the agency, in a draft report, to list C8 as a “likely human carcinogen.”

Last August, DuPont agreed to pay more than $107 million to settle a class-action lawsuit on behalf of more than 50,000 current and former plant neighbors whose water was tainted with C8.

Much of the money will fund a detailed review by private scientists of C8’s dangers and a landmark community health study in the Parkersburg area. Town meetings to explain the health study are scheduled to kick off Monday night in Parkersburg.

Under the settlement, DuPont could be on the hook for another $235 million in future medical monitoring if the studies find that C8 can make people sick. On top of that, the company also might face additional lawsuits if residents actually get sick from C8 exposure.

DuPont said again last week that it continues to believe that “the weight of evidence indicates that PFOA exposure does not pose a risk to the general public.”

“To date, no human health effects are known to be caused by PFOA, even in workers who have significantly higher exposure levels than the general public,” said Robert Rickard, DuPont’s chief toxicologist.

Fueled in large part by internal corporate records uncovered by the residents’ lawyers, the EPA in April 2003 launched a high-priority investigation of C8’s dangers.

In July 2004, the EPA sued DuPont for hiding important information about the chemical’s health effects. DuPont has announced that it has reached a tentative settlement with the EPA, but neither side has disclosed the terms of the deal.

At the same time, DuPont is facing a criminal investigation of its actions related to C8.

Late last year, EPA officials subpoenaed thousands of pages of documents from the residents’ lawyers. The records included sworn statements by residents and DuPont officials, and previously undisclosed corporate records.

As part of their lawsuit against the EPA, agency lawyers filed some of these records with an administrative law judge that is hearing the case. Those records are part of a public case file, but EPA officials would not release them without a formal Freedom of Information Act request.

Karrh’s discussion of the DuPont birth-defect data appears to be the biggest revelation in the previously undisclosed documents.

In his deposition, Karrh reported that a DuPont epidemiologist named Bill Fayerweather had proposed in April 1981 to do a detailed study of a potential link between C8 exposure and facial birth defects.

Fayerweather estimated that the rate of such birth defects in the general population was about two in every 1,000 people. If DuPont found two such problems in 10 children of plant workers, the rate would be “significantly higher” than that of the general population, Fayerweather found.

When he examined Washington Works employees, Fayerweather found two birth defects out of eight live births.

One child was born with an “unconfirmed eye and tear duct defect,” the DuPont study found. The other was born with “one nostril and eye defect,” the study said.

During a deposition, Rob Bilott, a lawyer for Wood County residents, showed Karrh photos of the children and asked him to describe them.

“The child has only one nostril,” Karrh said of one of the children. “Apparently, the right nostril is absent and it looks like there’s some growth on the inner surface of the right eye, on the medial surface.”

Karrh said that when he learned of the children years ago, he asked another DuPont doctor to look into the matter.

“He went back and did the evaluations that were asked of him, that I asked for him to make,” Karrh testified. “He came back to me and he was satisfied that it was not workplace related.”

The other doctor never prepared a written report, and Karrh said he “didn’t recall speaking with him about how he made that decision.”

“He satisfied me, and we moved on to other things that we were doing,” Karrh said.

Just a month before Fayerweather proposed his study, 3M told DuPont that it had found facial birth defects in baby rats exposed to C8.

For years, 3M had supplied DuPont with the C8 it used. In 2000, 3M stopped making the product, citing safety and environmental concerns.

The DuPont birth-defect data has been made public before. But details of DuPont’s decision not to continue its study have not previously been disclosed.

In April 2003, the Washington-based Environmental Working Group wrote to the EPA to demand an investigation by the agency of DuPont’s handling of C8 issues.

Among other things, the organization cited a 1981 internal company study that found similar facial birth defects in two of eight women studied by DuPont. In a letter, group President Ken Cook complained that DuPont wrongly did not report the study results to the EPA.

Under the Toxic Substances Control Act, or TSCA, companies must tell the EPA when they find information “that reasonably supports the conclusion that [a chemical] presents a substantial risk of injury to health.”

In its lawsuit against DuPont, the EPA cited the same 1981 study document.

But the agency did not mention the birth-defects findings. Instead, the EPA focused on blood sampling that showed that C8 was able to move from mothers to babies through the umbilical cord. Agency lawyers noted that, a year later, in March 1982, DuPont did tell the EPA about similar movement of C8 from mother to baby in rat studies.

The EPA said that if it had known DuPont found C8 being transferred from mother to baby in humans sooner, federal officials could have moved more quickly to study the issue and perhaps take steps to protect the public.

DuPont has said, “there is no legal basis for the EPA’s allegations.”

“The company contends that it has fully complied with statutory reporting requirements and disputes any association between PFOA and harmful effects on human health or the environment,” DuPont officials said in a prepared statement.

In March 1982, 3M and DuPont met with EPA officials to discuss 3M’s rat study. No one from DuPont mentioned the human birth-defects data.

“We did not see that there was evidence that there was a substantial risk in those two possible cases of birth defects that could be related to C8 exposure,” Karrh testified. “So, therefore, we made the conclusion that there was not a reporting requirement on that.”

But it turned out that DuPont never really did the study that might have turned up that evidence.

By July 1981 — just three months after it was proposed — the C8 birth-defects study was listed in company documents as being “on hold.”

“There were so many other things going on,” Karrh testified. “There was no reason to do this study at that point in time, so, therefore, it was decided to put it on hold until we got the results from these other studies and then we could always go back and do it if we felt an indication for it.”

In 1978, Karrh wrote a scientific journal article that advised companies to always report potential health threats from their chemicals to regulators.

“When it comes to such intensely emotional subjects as occupationally related cancer and chronic illness caused by workplace conditions, a company cannot risk the possibility of being placed in the compromising position of withholding information or making a false judgment about who should know what,” he wrote. “It is the duty of every company’s management to discover and reveal the unvarnished facts about health hazards.”

Why then, Bilott asked, did Karrh not tell the EPA about DuPont’s human birth-defects data?

“If you reported every little thing because it wasn’t — just because it very possibly a thousand years from now could be, then you’d lose the whole purpose of it.”

To contact staff writer Ken Ward Jr., use e-mail or call 348-1702.

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