updated 2/20/2004 7:20:14 AM ET 2004-02-20T12:20:14

Dosing volunteers with toxic pesticides and pollutants for scientific purposes is justified only under strict conditions and with careful review, a National Academy of Sciences panel said Thursday.

The Environmental Protection Agency should establish a special review board to evaluate any studies that involve intentionally giving people toxic chemicals, the committee said.

“Human studies involving pesticides, air pollutants, or other toxicants — as opposed to therapeutic agents — are particularly controversial, and because of this, EPA should subject these studies to the highest level of scientific and ethical scrutiny,” said committee co-chairman James Childress, a professor of ethics and medical education at the University of Virginia.

Erik Olson of the Natural Resources Defense Council said he was very troubled by the report. “We find it gravely disturbing,” he said, that toxic chemicals could be tested on humans and that the government would use the results of such tests done by industry in the past.

EPA spokeswoman Cynthia Bergman said the agency was still reviewing the report and had no immediate response.

CropLife America, a pesticide industry trade group, welcomed the report, saying it agrees “with the major finding that human testing is ethical, provided there are safeguards and sound science is used.

“Our industry is ethically and legally bound to provide regulators the information they need to determine that products are safe as they set stringent guidelines for their proper use,” the group said in a statement.

The panel convened by the National Research Council, the operating arm of the academy, looked at 19 pesticide studies received by EPA since 1991 involving volunteers.

It said any human testing of chemicals must be approached with the utmost caution and care.

Test children?
Asked about the possibility of testing in children, committee member Ellen Wright Clayton of Vanderbilt University said the panel urged EPA to adopt procedures used by other government agencies that say testing in children must seek to answer a question of enormous importance that can’t be done in another way and must be reviewed by both a local and national review board.

“I suppose it is possible to imagine a study that might meet those criteria,” she said, but the panel didn’t try to come up with an example.

EPA generally assesses human risk by determining the lowest level that is harmful to lab animals and extrapolating from that. But it has sponsored human studies when it considered them necessary to set health-related regulations.

The academy panel said intentional dosing studies in humans should be considered only if all of a set of conditions are met. Those were:

  • The work must address important regulatory questions that cannot be answered with animal studies or other studies that do not involve human testing. They must be designed, conducted, and reported in a scientifically rigorous manner to ensure that they answer a specific research question.
  • The possible benefits to society from the research must outweigh any anticipated risks to participants.
  • Studies to be used only for improving the scientific accuracy of EPA’s established reference doses for humans, but which would not provide health benefits otherwise, would be justified only if there were no identifiable risks to participants, or if investigators could show with reasonable certainty that participants would not be harmed.
  • All recognized ethical standards and procedures for protecting the interests of study participants must be observed, including equitable selection and recruitment of human subjects, the obtaining of informed consent and independent review of the scientific and ethical merits of the study by an institutional review board.

Origin in pesticides tests
EPA turned to the academy for advice after a debate over human studies broke out when pesticide manufacturers — seeking to show that a set of 1996 standards for pesticides in food were too strict — conducted a series of studies on humans and submitted them as evidence.

Those studies were challenged by some scientists, environmentalists and public interest groups on ethical grounds, arguing that people should not be put at risk to establish regulatory standards.

The academy committee concluded that “improving the accuracy of the science employed in regulatory decisions ... constitutes a societal benefit that can justify the conduct of a human dosing study.”

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