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Science Panel Says Pesticide Testing on Humans Is Ethical
(Beyond Pesticides, February 24, 2004)
The National Academy of Sciences released a disconcerting report last week, stating that pesticide research using human test subjects is ethical, and proposed a framework for the Environmental Protection Agency’s (EPA) oversight of such research. The committee that wrote the report includes scientists with close ties to the chemical industry. It was co-chaired by a former pesticide industry executive and lawyer, Michael Taylor, and included at least three chemical industry consultants.

The issue of human testing has been hotly debated in recent years. In 1996, Congress passed the Food Quality and Protection Act, which tightened safety standards on pesticides. Some chemical manufacturers were critical of the new standards and sponsored or conducted clinical trials to assess human risk from exposure to pesticides and submitted the results to the agency for consideration. In response, an outcry arose from public health and environmental advocates, who urged EPA to reject the results.

In 1998, EPA announced that it would not use the human test studies to inform its policy-making until “many ethical and scientific issues had been resolved.” Later, a majority of a joint subcommittee of EPA's Science Advisory Board and the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel concluded that human dosing studies could be ethically and scientifically justified under certain circumstances, subject to stringent conditions and oversight. EPA sought a broader scientific review from the National Academies, whose National Research Council released “Intentional Human Dosing Studies for EPA Regulatory Purposes” on February 19.

There are major discrepancies in the report. "The Academy report calls for the highest ethical and scientific standards, but undermines its own recommendations by making the appalling suggestion that it is okay to experiment with toxins on kids," said Erik D. Olson, a senior attorney at Natural Resources Defense Council (NRDC). "The report also shockingly says that federal agencies should accept the results of old, ethically questionable experiments with toxic chemicals on people unless there is 'clear and convincing evidence' that they were intended to hurt people or were otherwise absurdly unethical. We thought that these issues were resolved 50 years ago after the Nuremberg trials, but the chemical industry continues its campaign to make it acceptable to use human guinea pigs to maximize their profits. Shame on them."

NRDC pointed to specific inconsistencies in the report: “It appropriately calls for the highest ethical and scientific standards for human tests on the one hand (pp. 1-3), but then suggests elsewhere that many of these standards could be discretionary or "not inflexible" (pp. 10, 12), and not applied to industry tests that already have been completed unless there is "clear and convincing evidence" that they were "intended to seriously harm" the subjects or "failed to obtain informed consent" using a flexible definition of that term (p. 16).

It also recommends on the one hand that human studies should only be allowed if there is a "compelling scientific need" to answer questions that "cannot be answered with animal studies or non-dosing human studies" (p. 4), but later says that chemical industry studies intended to weaken health standards, with no human health or environmental benefit, should be allowed in some cases (p.7). Further, it urges that studies used to improve the accuracy of standards pose a "reasonable certainty of no harm" (p.7), but then urges that a compensation scheme be adopted to provide free medical care for human subjects who have been harmed by industry experiments (p. 10). Finally, it recommends a new EPA ethical and scientific review board to review all human studies before and after they are completed (pp. 11-12), but then says that past studies that were not reviewed by EPA beforehand could be accepted (pp. 14-16).”

An example of an older study using human subjects was conducted by Bayer in 1998, and involved human consumption of organophosphate pesticides. Three years later the company behind the tests was accused of breaking the Nuremberg Code -- established as a response to Nazi experimentation on Jews -- and of using the results to boost profits. One of the 50 Scots who were a part of the human testing, Bruce Turnbull, blew the whistle on Bayer. Read more from Beyond Pesticides’ Daily News.

Pesticides are traditionally tested on animals, and safe levels for humans are extrapolated from those to account for children's heightened sensitivity. Many human-tested pesticides use young adults as subjects. In doing so, adjustments for child sensitivity are avoided.

Beyond concerns in extrapolation is the controversial question of the ethicality of testing hazardous substances on humans. Codes of medical ethics were specifically designed to prevent potentially harmful experiments from being performed on humans. Studies using humans as test subjects "do harm" by the nature of the tests. Pesticides are proven poisons used to kill insects, plants diseases, weeds, rodents, and germs, and administering these toxic materials to people, as part of a controlled experiment, is a practice that can only do harm to the test subjects involved. Regardless of the results, participants are dosed with highly toxic chemicals; there are no possible health benefits to the human test subjects from being exposed to specifically designed poisons.

TAKE ACTION: Contact Mr. Michael Leavitt Leavitt, EPA Administrator, by email, phone: 202-564-4711, or fax: 202-501-1470 to urge EPA to reject pesticide testing on humans. For more information, read Beyond Pesticides’ comments to EPA regarding human testing.