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A National Academy of Sciences (NAS) committee listened to heated comments Wednesday at an open forum on the question of whether the Environmental Protection Agency (EPA) should use data from tests of pesticides and other toxic chemicals on human volunteers in its regulatory decision making.
Since 1998, EPA has observed an informal self-imposed moratorium on considering such human toxicity tests during the regulatory process. But in December 2001, EPA asked NAS to examine the issue and offer advice on whether to revise the policy.
"The task to be undertaken by this committee … is to offer the EPA advice on when, if ever, it is legitimate scientifically and/or ethically to conduct studies on human volunteers who are exposed to substances from which they derive no therapeutic benefit," explained Michael Taylor, co-chair of the NAS Committee on Use of Third-Party Toxicity Research with Human Participants.
The committee, which is expected to produce its final report by the end of this year, heard from a range of chemical and pesticide companies as well as health experts Wednesday.
Environmentalists and public health activists said they strongly oppose the idea of the EPA considering the data from tests in which paid volunteers ingest toxic substances.
"This is not research designed to find a cure for a disease or to generate a new scientific advance," said Richard Wiles, vice president for research, Environmental Working Group, Washington, DC. "This is research designed to further the goals of those who pay for it. And those goals are to relax pollution limits, relax drinking water contaminant limits, and to allow more pesticides in or on food."
Chemical industry representatives argued that tests on animals are no substitute for measuring the toxicity of pesticides and other industrial chemicals in humans.
"We believe it's irresponsible not to use available human data to assess the risk of pesticide exposure," said Ray McAllister, vice president for science and regulatory affairs for CropLife America, Washington, DC, a pesticide industry trade association.
CropLife America, along with several pesticide companies, filed suit against the EPA last year to force it to include human toxicity tests in its decision-making. The tests, which are contracted out to private labs, involve volunteers paid for their participation. Oral argument in the suit is scheduled for March.
At the forum, the NAS committee focused on data about four toxic chemicals: Aldicarb, a pesticide that has been found to contaminate groundwater; Malathion, a pesticide in wide use in Florida, Texas and California; Dichlorvos, an insecticide that has been used for more than 50 years; and Perchlorate, a primary ingredient in solid rocket fuel.
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