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http://www.nytimes.com/2003/01/09/national/09TOXI.html

Debate Erupts Over Testing Pesticides on Humans

By DENISE GRADY

ASHINGTON, Jan. 8 — Pesticide makers sparred with health and environmental advocates here today over a contentious subject, whether the Environmental Protection Agency should accept figures from studies in which researchers have had people drink pesticides or other chemicals to determine toxicity.

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Such studies have been conducted in the United States and overseas with volunteers who are paid from a few hundred dollars to more than $1,000. The studies are not common, a spokesman for the E.P.A. said, noting that in the last four years 15 had been submitted to the agency.

In 1998, citing ethical and scientific concerns, the agency declared a moratorium on using such information. In December 2001, it asked the National Academy of Sciences to convene an expert panel to provide advice. The panel, which met today at the academy headquarters to hear public comments, is to issue its report in December. An earlier advisory panel, not from the academy, struggled with the same subject but did not reach a consensus.

Dr. Lynn Goldman, a former E.P.A. official who is a professor at Johns Hopkins University and the chairwoman of the board of the Children's Environmental Health Network, said pesticide makers had renewed their interest in human studies. Dr. Goldman said such studies had been used in the past but declined in the 1980's, probably because it became more difficult to obtain ethicists' approval.
One reason pesticide makers want the studies, Dr. Goldman and other participants said, is the Food Quality Protection Act of 1996. The law sharply reduced the levels of many pesticides allowed in food, to protect younger children. The levels permitted vary among substances, depending on toxicity tests in animals.

Pesticide makers say although animal studies are often valid, they can be misleading, because animals may be much more or much less sensitive than humans to certain chemicals. In some cases, companies say, human studies are indispensable.

CropLife, a trade group for pesticide manufacturers and distributors, sued in federal court last year to require the E.P.A. to consider information from toxicity studies in humans. The senior vice president and general counsel, Douglas T. Nelson, said the agency's refusal to use the studies violated several laws, including a statute that compels it to consider all relevant and reliable data.

At the meeting today, scientists and consultants who work for pesticide and chemical companies said that their human studies were carried out with high scientific and ethical standards and that subjects were not harmed. A spokesman for CropLife likened pesticide studies to pharmaceutical studies and referred to the pesticide tests as clinical trials, the name given to medical experiments on people.

Asked by a panel member whether they knew of any cases with adverse effects that were not reported, four researchers who had just described chemical tests in humans said no.

But environmental and health advocates said the pesticide makers really wanted to create studies that would help them lower the standards in the Food Quality Protection Act.

Dr. Alan H. Lockwood, a professor of neurology and nuclear medicine at the State University at Buffalo, spoke on behalf of Physicians for Social Responsibility, a 23,000-member group that opposes using people to study the toxicity of pesticides or other chemicals. One basis for the objection, Dr. Lockwood said, is the position that the studies violate the doctor's oath to "do no harm."

He quoted a consent form for participants in a study of a pesticide, chlorpyrifos, that said, "Low doses of these agents have been shown to improve performance on numerous tests of mental function."

Dr. Lockwood said, "This makes it sound like chlorpyrifos is good for you and may make you smarter, a clear deception."

Dr. Jennifer Sass, a senior scientist at the Natural Resources Defense Council, said industry studies often included too few subjects to be scientifically reliable, stated conclusions that did not match the data and often went unpublished.

Industry representatives disputed her comments. A statistician working for pesticide makers said the studies being questioned were sound.

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