WASHINGTON – The Environmental Protection Agency for the first time is establishing criteria for tests by pesticide makers on human subjects.
Susan Hazen, the EPA’s principal deputy assistant administrator for the Office of Prevention, Pesticides and Toxic Substances, said Monday the new rule for accepting tests won’t allow “intentional pesticide dosing studies of children and pregnant women.”
Last year, President Bush signed a ban on the use of human pesticide test data until the EPA created regulations for accepting them. The agency also was required to ban the use of pregnant women and children as subjects, and to incorporate ethical guidelines from the National Academy of Sciences and the post-World War II Nuremberg Code.
“We have met and exceeded Congress’ direction,” Hazen said.
Three California Democrats, Sen. Barbara Boxer and Reps. Henry Waxman and Hilda Solis, denounced the new rule after obtaining a copy of the final draft. They had led the effort in Congress to require that the EPA outlaw the use of pregnant women and children as subjects and that it meet high ethical standards.
Boxer said the EPA rule is inconsistent with what Congress ordered. She said manufacturers could still conduct testing on pregnant women and children as long as they could convince the EPA that the researchers didn’t intend to submit the results to the agency at the outset of the study.
Hazen said, however, that the only exception to the ban on accepting data involves cases in which the EPA becomes aware that it might need to take additional measures to protect public health.
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