- 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.
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- 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.
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- 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.
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- 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.
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- 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."
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- 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.
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- 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."
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- Sources
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- Los Angeles Times, November 27, 2001 Associated Press,
November 27, 2001 New York Times, November 28, 2001 Washington Post, November
29, 2001
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- 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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