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Washington, DC — The U.S. Environmental Protection Agency is still struggling with deciding what ethical safeguards are needed in its experiments testing pesticides and other chemicals on human beings. EPA’s latest effort pointedly avoids laying out concrete rules on acceptable risk to human subjects, particularly children, use of prisoners, the mentally ill and other vulnerable populations, economic inducements for poor people to join experiments, and a host of other controversies, according to public comments filed today by Public Employees for Environmental Responsibility (PEER).

EPA formally legalized human subject experimentation on February 6, 2007, but prior to that, the Bush administration conducted and encouraged human subject studies on a case-by-case basis. The most notorious case involved the Children’s Environmental Exposure Research Study (bearing the anomalous acronym CHEERS) in which Florida parents would have been paid to spray pesticides in the rooms of their children under age three. EPA designed the study with funding from the American Chemistry Council, which represents 135 companies including pesticide manufacturers.

The outcry over CHEERS forced EPA to grudgingly cancel the experiment in April 2005 during the confirmation hearing of EPA Administrator Stephen Johnson, the agency’s biggest advocate for using human experiments as the basis for official decisions about exposure levels and related topics.

This Monday, November 19, 2007, the public comment period will end on EPA’s newest attempt to allay public concerns about the ethics of using human guinea pigs for experiments that bring only risk and no benefits to participants. This latest draft, entitled Scientific and Ethical Approaches for Observational Exposure Studies, was written by the EPA principal investigator for CHEERS but does not once mention that now infamous study. In fact, the document does not provide any formal guidance on an array of ethical quandaries, including use of children or vulnerable populations, conflicts-of-interest by scientists and reviewers, and other thorny issues.

“What EPA does not want to say is that its rules actually endorse CHEERS, so that similar experiments with babies crawling across puddles of pesticide are considered legitimate,” stated PEER Executive Director Jeff Ruch, noting that the purpose of CHEERS was to measure pesticide absorption in the infants’ systems through urine testing. “Rather than impose strict guidelines against abuse, EPA is trying to sidle its way into a posture of moral flexibility – where harm to human subjects can be overlooked.”

Following public comment, the draft EPA paper will be distributed to staff scientists as a “resource” to aid “observational exposure studies.” In the meantime, EPA is accepting submissions from industry which have even looser ethical restrictions than those that apply to agency-funded work. Industry-conducted human experimentation has few ethical limits and those few rules are enforced only by EPA’s refusal to consider human test results in making regulatory decisions.

“EPA has opened the door for a repetition of the sort of abusive human experiments witnessed in the first half of the 20th century,” Ruch added. “This is just the latest instance of the Bush administration shrinking from calls by Congress and scientific bodies to set forth clear ethical rules governing human experiments undertaken for economic reasons.”


Read the PEER comments

See EPA’s Scientific and Ethical Approaches for Observational Exposure Studies

Revisit the infamous, now-cancelled CHEERS experiment

Look at the gaps in EPA ethics rules for human subject studies

View the Federal Register notice

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