A panel of the National Research Council said Thursday that human
test subjects could be intentionally given doses of pesticides and other toxic
substances as long as the companies or government agencies conducting the
tests meet high ethical and scientific standards.
The Bush administration sought advice from the panel of scientists and
ethicists after it controversially reversed a Clinton-era moratorium on the
use of paid volunteers in tests that aid Environmental Protection Agency
officials in determining safe exposure levels for pesticides used on fruits,
vegetables and other crops. The agency is not bound by the panel's
recommendations, but it is expected to give them much weight as it establishes
a new policy on human testing.
In these tests, individuals are given doses of pesticides at levels that
are not anticipated to cause harm. The pesticide companies want EPA officials
to consult the results of the tests on humans, in addition to studies on
laboratory animals, when they decide how much of a particular pesticide can be
applied to crops and how close to harvest it can be applied.
Although human tests funded by pesticide companies prompted the report,
the panel said its advice and admonitions extended to the use of human
subjects in any tests of toxic chemicals or pollutants, such as the in-house
tests the EPA does to set health-based standards for air pollution, or outside
tests done to establish the risk caused by perchlorate, or rocket fuel, in
The panel stressed that a human test could be acceptable only if several
stiff criteria were met, such as ensuring that the test addresses important
regulatory questions that cannot be answered without it and that the possible
benefits to society outweigh the anticipated risks for participants. It urged
the EPA to set up a review board to evaluate the tests.
"Human studies involving pesticides, air pollutants or other toxicants -- as opposed to therapeutic agents -- are particularly controversial, and
because of this, EPA should subject these studies to the highest level of
scientific and ethical scrutiny," said James Childress, co-chairman of the
panel and director of the Institute for Practical Ethics at the University of
He said the panel had decided not to advocate banning human tests because
it had determined that there is a public benefit in using the best available
Human testing for pesticides was rare until 1996, when Congress passed
the Food Quality and Protection Act, which tightened safety standards for
pesticides and was particularly aimed at making them safe for children. The
companies started conducting the tests to show that the standards were
stricter than necessary to protect human health.
But after environmentalists, public health advocates and others
complained, the EPA in 1998 halted such tests. In late 2001, the Bush
administration quietly reversed that decision.
A month later, after newspapers reported that the moratorium on human
testing had been lifted, the EPA reinstated it until the National Research
Council study was completed.
Last June, a federal appeals court told the government that the EPA had
broken the law in the way that it established the moratorium and directed the
agency to resume the practice of considering human tests on a case-by-case
basis. Since then, the EPA has not relied on the results of human tests in
making any decision on pesticides, according to Dave Deegan, an EPA spokesman.
Some neurologists and environmental activists criticized the panel for
giving a green light for companies to conduct the tests, which serve no
purpose besides relaxing regulations on chemicals. They were especially
critical of the panel for potentially allowing the use of children as subjects
for such tests.
"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 (its) profits," said Erik
Olson, a senior attorney for the Natural Resources Defense Council, an
But representatives of the pesticide industry stressed that the panel's
report would enable the industry to conduct the tests on human subjects that
are necessary to show that EPA does not need to be overly restrictive when it
sets pesticide exposure levels.
"It's of no benefit to anyone to have products restricted with no basis,"
said Patrick Donnelly, executive vice president of CropLife America, a trade
group for pesticide companies.
Copyright 2004 Los Angeles Times