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.
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."
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
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."