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U.S. EPA to Allow Human Pesticide Tests
December 14, 2001
The U.S. Environmental Protection Agency (EPA) will accept data from pesticide tests that use human subjects, an EPA administrator announced in late November. The announcement--made at a meeting of the nation's largest pesticide industry lobbying group, the American Crop Protection Association--reverses a moratorium on human tests established during the Clinton administration. Although the administrator said that a formal EPA policy for accepting such tests has not been finalized, he admitted that the EPA has recently reviewed data from studies involving human subjects carried out by pesticide companies.
In 1998, a scientific advisory panel of doctors, ethicists and scientists brought together by the EPA concluded that human testing of pesticides "to facilitate the interests of industry or of agriculture" is unjustifiable. Human testing is acceptable only if it "promise[s] reasonable health benefits to the individual or society at large," says the panel's February 2000 report.
Critics also argue that human testing for pesticide safety violates the Nuremburg Code, an outline of the rights of medical research subjects established by U.S. judges at the Nazi war crimes tribunals in 1947. The Code states that human tests are justified only if they are likely "to yield fruitful results for the good of society, unprovable by other methods or means of study." The pesticide industry tests recently accepted by the EPA, which would lead only to increased application of the pesticides tested and which could be carried out on animals, do not appear to meet these criteria. According to Lynn Goldman, former EPA pesticide program director, the only reason such tests are being conducted is to make more money for pesticide companies.
Between 1986 and 1996, only a handful of human tests were submitted to the EPA. With the passage of the Food Quality Protection Act (FQPA) in 1996, however, the number of human tests increased dramatically. The FQPA requires that 9,000 pesticides be reassessed for their potential impact on children. Pesticide manufacturers are required to multiply the safe exposure level from animal studies by 10 to ensure safety for human children. These strengthened regulations have led the pesticide industry to pursue human testing, arguing that such testing allows them to more accurately assess the safe exposure threshold. "The dreadful irony," says Nancy Myers, communications director at the Science and Environmental Health Network, "is that this human data, which the manufacturers are so eager to provide, is not as helpful as the animal data that they have been ordered, and failed, to produce." The human tests are carried out on adults, leaving the question of establishing safety thresholds for children unresolved, Myers notes.
The design of the human tests is both scientifically and ethically flawed, critics say. Dr. Herbert Needleman, a pediatrician and psychiatrist at the University of Pittsburgh School of Medicine, and one of the members of the Clinton administration scientific advisory panel, says that the human tests "have very small numbers of subjects and look at very crude outcomes and come to the conclusion that no health effects were seen." Myers explains that "good science would mean getting more people to swallow more pesticide pills over a longer period of time. To conduct really good scientific experiments and get the best data, you'd have to kill people. That's the fallacy of trying to keep this controversy in the realm of 'science' rather than ethics."
Most of the human studies considered by the EPA in recent years were conducted abroad. In 1999, however, Dow AgroSciences paid 60 volunteers in Nebraska to swallow tablets, half of which were placebos and half of which were laced with the pesticide chlorpyrifos (trade names Dursban and Lorsban). Each volunteer was paid US$460. Dow said that the tests showed no signs of toxicity. Similar tests will likely be undertaken on a wider scale now that the EPA has given its approval. The scientific advisory committee had urged the EPA to establish rigorous standards for human testing and to require pre-approval of proposed studies by an independent review board. No such restrictions have been published to date.
Dr. Needleman believes that the legitimation of human studies "is a power move on the part of pesticide manufacturers, and the EPA administrator and others rolled over." Goldman, who is now a professor of environmental sciences at Johns Hopkins University, points out that "for industry, there is an enormous amount of money in the balance; one study can make the difference of tens of millions of dollars."
UPDATE: Less than three weeks after EPA's decision to accept human pesticide tests, the agency announced a temporary moratorium on human testing pending recommendations of an ethical and scientific review by the National Academy of Sciences. While critics of human testing welcomed the moratorium, the president of the American Crop Protection Association said that some pesticide companies may sue the EPA to force them to consider human tests.
Sources: Los Angeles Times, November 27, 2001; Associated Press, November 27, 2001; New York Times, November 28, 2001, December 15, 2001; Washington Post, November 29, 2001, December 15, 2001; Trials of War Criminals Before the Nuremburg Military Tribunals under Control Council Law, No. 10, Vol. 2. Nancy Myers, personal communication, December 12, 2001.
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