However, an EPA spokesman did say the agency will be developing a proposal on incorporating data from human clinical trials in regulatory decisions on pesticides and soliciting comments on it over the next few months.

This is a reversal of an informal policy established during the Clinton Administration, under which EPA refused to accept new data from clinical trials in which people were deliberately exposed to pesticides. According to a 1998 policy statement: "EPA is deeply concerned that some pesticide manufacturers seem to be engaging in health effects studies on human subjects as a way to avoid more protective results from animal tests under the new Food Quality Protection Act." The purpose of human tests is to avoid the 10-fold safety factor that must be used when extrapolating from animal data to human exposure.

"In our opinion, human clinical trials with pesticides are unethical, immoral, and unscientific," says Elliot Negin of the Natural Resources Defense Council. They are unethical, he says, "because often the subjects are financially strapped, not very bright, and don't necessarily know what they are getting themselves into." The tests are unscientific, he explains, because the exposure groups cannot be large enough to detect responses that would occur in only a small fraction (3 to 4%) of the population.

However, Jay J. Vroom, president of the American Crop Protection Association, says human test data can be collected in an ethical manner and that such data should be used to strengthen regulatory decisions. It is scientifically valid to use data from a small number of subjects--10 or 20--he says, because the goals are narrow. "You are basically testing to see whether the human response to the pesticide parallels the animal response," he says.

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