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 studies met high ethical and scientific standards.
The Bush administration sought advice from the panel of scientists and ethicists after it reversed, in a controversial move, a Clinton-era moratorium on the use of paid volunteers in tests that aid the Environmental Protection Agency in determining safe exposure levels for pesticides used on fruits, vegetables and other crops.
The EPA is not bound by the panel’s recommendations, but it is expected to give them much weight as it establishes a new test 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 consider 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 used.
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 studies of toxic chemicals or pollutants, such as in-house tests the EPA does to set health-based standards for air pollution, or outside ones done to establish the risk caused by perchlorate, or rocket fuel, in drinking water.
The panel emphasized that a human test could be acceptable only if several stiff criteria were met, such as ensuring that the study addressed important regulatory questions that could not be answered without it and that the possible benefits to society outweighed 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 F. Childress, co-chairman of the panel and director of the Institute for Practical Ethics & Public Life at the University of Virginia.
He said the panel had decided not to advocate banning human tests because it had determined that there was 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. Firms started conducting the tests to show that the standards were stricter than necessary to protect human health.
Some neurologists and environmental activists criticized the panel for giving firms a green light to conduct the tests, which they say serve no purpose besides relaxing regulations on chemicals. They were especially critical of the panel for potentially allowing the use of children as test subjects.
“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 D. Olson, a senior lawyer for the Natural Resources Defense Council, an environmental group.
Representatives of the pesticide industry emphasized that the report would enable the industry to conduct the tests on humans that are necessary to show that the EPA does not need to be overly restrictive when it sets pesticide-exposure levels. This way, they said, farmers will still have the use of pesticides that they need to supply food to American families.
“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.
He said consumers had no need to be concerned about the integrity of the tests or their implications for pesticide regulations.