EPA Told to Weigh Human Pesticide Test Data

A federal appeals court Tuesday directed the government to resume considering the results of tests on human subjects as it determines acceptable exposure levels to toxic pesticides.

The U.S. Court of Appeals for the District of Columbia ruled that the Environmental Protection Agency had used flawed procedures when, in December 2001, it imposed a moratorium on using the data from human tests to determine allowable pesticide levels.

At that time, EPA Administrator Christie Whitman declared that the agency would not consider data from human clinical studies while it examined the ethical and scientific acceptability of the tests.

The pesticide industry sued, arguing that the EPA broke the law by setting the moratorium without first issuing a notice of its plans and then collecting public comment.

The court agreed, and directed the agency to accept data from human tests on a case-by-case basis, using high ethical standards, at least until it establishes a new regulation.

EPA spokesman Joe Martyak said the agency was disappointed in the ruling and was evaluating its options.

When announcing the ban, the agency sought the advice of the National Academy of Sciences on whether it was appropriate to intentionally expose human subjects to small amounts of toxic pesticides. The agency expects a report from an academy panel this year.

The EPA also announced last month that it planned to propose new testing regulations. Martyak said it was not known how long it would take to develop the rules.

Environmental groups criticized the court for effectively sanctioning the practice of exposing people to toxic chemicals to help the pesticide industry win approval for some of its riskiest products.

“We are very concerned it will unleash a tidal wave of industry tests on people that are unethical and unscientific,” said Erik Olson, a senior attorney for the Natural Resources Defense Council.

The pesticide industry applauded the decision, saying that it could help keep some pesticides on the market the EPA might have regulated so aggressively that they could no longer be used effectively.

The EPA determines how much of a particular pesticide can be applied to crops and how close to harvest time it can be applied. Too much exposure to some pesticides can result in neurological damage, cancer or other serious illnesses.

Jay Vroom, the president of CropLife America, the industry group that brought the suit, said he did not expect the ruling to result in a proliferation of clinical tests on human subjects because these tests are necessary only when human data are “essential to the continued use of the product.”

“I don’t think that means there will be any significant increase in the number of these kinds of trial studies,” Vroom said.

Most of the data that the industry supplies to the EPA for its pesticide regulations come from tests on laboratory animals. Regulators determine an exposure level for humans that is 10 times more protective than what they regard as safe for animals.

Pesticide companies sponsor clinical tests on volunteers in an effort to prove to regulators that pesticides are no more harmful to humans than they are to laboratory animals. The goal is to persuade the EPA to reduce or eliminate the 10-fold safety cushion.

Environmentalist have criticized human tests on grounds that they generally involve groups statistically too small to prove the pesticides are safe for people who might be susceptible. The size of the test groups ranges from a few people to several dozen.

But Vroom said the small human test groups are adequate because the pesticide companies already have done extensive testing on animals.

“We’re only trying to validate clear questions that have been established by animal testing that has gone ahead of it for years,” he said.

Critics also say that the tests cannot predict the impact of pesticides on children or the elderly because they are not included in the studies.

Whitman announced the ban just weeks after press accounts revealed that Bush administration officials -- soon after taking office -- had told the industry human test results would be considered, reversing an informal ban on such tests set by the Clinton administration.

Whitman said then: “Our paramount concern in developing our policy on these studies must be the protection of human health and adherence to the most rigorous ethical and scientific standards.”

With Whitman leaving the EPA this month, environmentalists have expressed concern that her successor may not have her commitment.

“We are wary that, especially with Administrator Whitman leaving, the Bush administration might try to use this court decision as an excuse to accept industry’s human tests,” said Olson, whose environmental group intervened in the suit on behalf of the EPA.

The court decision comes at a time when the EPA is reassessing 9,000 pesticide safety levels to reflect their effect on children. In general, children can tolerate smaller amounts of pesticides than adults.