5 June 2003
Told to Weigh Human Pesticide Test Data
* The industry prevails against the agency, which had imposed a
ban while it sought to determine acceptable toxic exposure levels.
— A federal appeals court Tuesday directed the government
to resume considering the results of tests on human subjects as
it determines acceptable exposure levels to toxic pesticides.
U.S. Court of Appeals for the District of Columbia ruled that the
Environmental Protection Agency had used flawed procedures when,
in December 2001, it imposed a moratorium on using the data from
human tests to determine allowable pesticide levels.
that time, EPA Administrator Christie Whitman declared that the
agency would not consider data from human clinical studies while
it examined the ethical and scientific acceptability of the tests.
pesticide industry sued, arguing that the EPA broke the law by setting
the moratorium without first issuing a notice of its plans and then
collecting public comment.
court agreed, and directed the agency to accept data from human
tests on a case-by-case basis, using high ethical standards, at
least until it establishes a new regulation.
spokesman Joe Martyak said the agency was disappointed in the ruling
and was evaluating its options.
announcing the ban, the agency sought the advice of the National
Academy of Sciences on whether it was appropriate to intentionally
expose human subjects to small amounts of toxic pesticides. The
agency expects a report from an academy panel this year.
EPA also announced last month that it planned to propose new testing
regulations. Martyak said it was not known how long it would take
to develop the rules.
groups criticized the court for effectively sanctioning the practice
of exposing people to toxic chemicals to help the pesticide industry
win approval for some of its riskiest products.
are very concerned it will unleash a tidal wave of industry tests
on people that are unethical and unscientific," said Erik Olson,
a senior attorney for the Natural Resources Defense Council.
pesticide industry applauded the decision, saying that it could
help keep some pesticides on the market the EPA might have regulated
so aggressively that they could no longer be used effectively.
EPA determines how much of a particular pesticide can be applied
to crops and how close to harvest time it can be applied. Too much
exposure to some pesticides can result in neurological damage, cancer
or other serious illnesses.
Vroom, the president of CropLife America, the industry group that
brought the suit, said he did not expect the ruling to result in
a proliferation of clinical tests on human subjects because these
tests are necessary only when human data are "essential to
the continued use of the product."
don't think that means there will be any significant increase in
the number of these kinds of trial studies," Vroom said.
of the data that the industry supplies to the EPA for its pesticide
regulations come from tests on laboratory animals. Regulators determine
an exposure level for humans that is 10 times more protective than
what they regard as safe for animals.
companies sponsor clinical tests on volunteers in an effort to prove
to regulators that pesticides are no more harmful to humans than
they are to laboratory animals. The goal is to persuade the EPA
to reduce or eliminate the 10-fold safety cushion.
have criticized human tests on grounds that they generally involve
groups statistically too small to prove the pesticides are safe
for people who might be susceptible. The size of the test groups
ranges from a few people to several dozen.
Vroom said the small human test groups are adequate because the
pesticide companies already have done extensive testing on animals.
only trying to validate clear questions that have been established
by animal testing that has gone ahead of it for years," he
also say that the tests cannot predict the impact of pesticides
on children or the elderly because they are not included in the
announced the ban just weeks after press accounts revealed that
Bush administration officials — soon after taking office —
had told the industry human test results would be considered, reversing
an informal ban on such tests set by the Clinton administration.
said then: "Our paramount concern in developing our policy
on these studies must be the protection of human health and adherence
to the most rigorous ethical and scientific standards."
Whitman leaving the EPA this month, environmentalists have expressed
concern that her successor may not have her commitment.
are wary that, especially with Administrator Whitman leaving, the
Bush administration might try to use this court decision as an excuse
to accept industry's human tests," said Olson, whose environmental
group intervened in the suit on behalf of the EPA.
court decision comes at a time when the EPA is reassessing 9,000
pesticide safety levels to reflect their effect on children. In
general, children can tolerate smaller amounts of pesticides than