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Human data debate

US environment agency considers ethics and utility of toxics tests on human volunteers.

Hannah Kamenetsky(hkamenetsky@mindspring.com)

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...

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