EPA Drafts Policy on Human Experimentation

EPA has drafted a new policy for accepting industry-submitted data from experiments using human subjects. In a notice to be published in the Federal Register, probably in January, EPA says it will not promulgate rules to prevent unethical practices at this time, but it will instead make decisions "concerning ethically problematic studies on a case-by-case basis." Under the new policy, the agency will accept human experimental data "unless there is clear evidence" of "fundamentally unethical" conduct, such as harm to the participants or "some form of undue coercion." Earlier this year, a National Research Council report recommended that EPA establish an independent human studies review panel to examine all studies involving exposure of human subjects to pesticides or other chemicals. But instead of creating a separate panel, senior officials in EPA's National Center for Environmental Assessment will decide on an individual case basis whether to accept the experimental data. Near the end of the Clinton Administration, EPA stopped accepting data from human studies, but after President George W. Bush took office, it resumed considering such data. "By this sleazy move, EPA abdicates its moral responsibility to ensure that the data submitted by industry do not use human beings as chemical guinea pigs," says Jeff Ruch, executive director of Public Employees for Environmental Responsibility, a whistleblower advocacy group that released the EPA draft policy prior to publication.