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U.S. Will Use Once-Banned Human Tests

Pesticides: EPA says it will accept industry data gathered by giving paid subjects chemical doses.


WASHINGTON — Three years ago, in response to mounting criticism from environmentalists and physicians, the Clinton administration stopped using information from industry studies conducted on humans to determine the amount of pesticides that could be applied to fruits, vegetables and other crops.

Now the Bush administration, siding with manufacturers on whether such studies are ethical and scientifically valid, has told the pesticide industry it will use data from such tests, in which paid volunteers swallow small doses of the products.

The new policy, which the Environmental Protection Agency has not announced, also appears to disregard the recommendations of a scientific panel the agency assembled in late 1998.

Two panel members called for a ban on human testing of pesticides, while the 16 others said such tests must be very limited. The panel of doctors, bioethicists and clinical scientists urged the EPA to adopt a clear policy on human testing, one that would require adherence to rigorous standards and pre-approval by an independent review board.

"The force of the report was, in general, that it shouldn't be done. There should be a very high threshold," said panel member Samuel Gorovitz, a professor of philosophy and public administration at Syracuse University.

The new policy could have a significant impact because it comes as the government is beginning to reassess about 9,000 pesticide safety levels to reflect their impact on children. In general, children can tolerate smaller amounts of pesticides, medicines and other substances than adults.

Federal regulators determine the amount of certain pesticides that people can tolerate on foods, in water and in agricultural jobs without harming their health. Too much exposure can result in neurological damage, cancer or other serious illnesses.

Though details of the new policy are unclear, industry officials welcome the shift. Without human tests, the government uses the results of animal testing and multiplies that exposure level by 10 to establish an exposure level considered safe for humans. The companies argue that human tests provide more accurate results, allowing pesticides to be applied to crops in larger quantities and closer to delivery to supermarkets.

Without human tests, regulations "end up being more conservative and more restrictive than they need to be," said Ray McAllister, vice president for science and regulatory affairs for the pesticide trade association.

If human subjects are not used, "you may be denying benefits not only to the grower producing the crop but also to society that needs the food at a reasonable price," he said. "There are secondary public health consequences if you don't have good crop protection."

Industry officials also noted that human volunteers are regularly used to test the effects of air pollution.

The administration first signaled the policy switch last month, when a top EPA official told the annual meeting of the American Crop Protection Assn. that the agency would consider the results of clinical tests on humans.

Assistant Administrator Stephen L. Johnson "indicated the agency would be looking at the human data that were submitted," McAllister said.

Also, documents on at least three pesticides submitted to the EPA in recent weeks for re-registration plainly state that the agency is considering data from tests on humans. The re-registration is mandated by the 1996 Food Quality Protection Act, which requires the EPA to reassess 9,000 currently registered pesticides for their impact on children.

An EPA official, speaking on the condition of anonymity, confirmed Johnson's remarks to the trade group, and other EPA officials acknowledged that the administration is developing a new policy on human testing of pesticides. But officials said they did not have approval from top political appointees to talk about it.

In its 10-month tenure, the Bush administration has weakened an array of Clinton administration environmental regulations and proposals, agreeing with industry and angering environmentalists. The rollbacks range from loosening energy efficiency standards for air conditioners to erasing a provision that would have allowed federal land managers to reject certain types of mines if they would cause irreparable damage to public land.

The administration also halted the implementation of new, stricter standards for arsenic in drinking water. After conducting its own tests, and under pressure from Congress, the EPA announced last month that it would adopt the Clinton administration standard.

In the decade before 1996, when the law requiring retesting of pesticides was passed, the EPA received only a handful of human tests. In the three years that followed, the agency received 14 new, unsolicited human subject studies on 10 pesticides.

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