Washington -- 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 drinking water.

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 Virginia.

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 science.

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 environmental group.

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

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