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NEWS OF THE WEEK
HEALTH & SAFETY
December 24, 2001
Volume 79, Number 52
CENEAR 79 52 p. 8
ISSN 0009-2347
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HUMAN TRIALS OF PESTICIDES
EPA issues a moratorium, asks NAS to review scientific and ethical issues

BETTE HILEMAN

The Environmental Protection Agency has announced a moratorium on considering human test results for purposes of assessing pesticide safety.

"Our paramount concern in developing our policy on these studies must be protection of human health and adherence to the most rigorous ethical and scientific standards."

Christine Todd Whitman, EPA administrator

Earlier this year, the Bush Administration decided to consider the results of trials in which human volunteers are fed pesticides to identify or quantify any adverse effects. This was a reversal of the Clinton Administration's policy.

EPA was given the results from tests of the pesticides azinphos methyl, chlorpyrifos, and phosmet in which human volunteers were given pesticide doses hundreds of times higher than levels considered safe for the general population. If such data are available, EPA does not have to impose the 10-fold safety factor required under the Food Quality & Protection Act when extrapolating from animal data to human exposure.

Now, EPA has asked the National Academy of Sciences to review the complex scientific and ethical issues surrounding the use of human studies conducted by outside parties, such as pesticide makers.The results of the NAS review will weigh heavily on EPA policy regarding human trials.

Specifically, NAS will consider whether the Common Rule, an internationally accepted protocol that federal agencies must follow in conducting human trials, should be applied to studies conducted by pesticide registrants.

Richard Wiles, senior vice president of the Environmental Working Group, says EPA's moratorium should be permanent. Human studies are bad science, he says, because the exposed groups are too small to detect harmful effects that might occur in a small fraction of the population.

"We disagree with EPA's moratorium," says Jay J. Vroom, president of the American Crop Protection Association. "EPA is required to consider all available and reliable data in evaluating pesticides. That's what the law says," he explains.

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