Pesticides Now Being Tested
On Human Volunteers
By Brent Walth
Newhouse News Service

Not too long ago it looked as if the growing battle over pesticides in the United States would be turned with help from 50 people in Scotland. The Scots earlier this summer were subjects in the growing, and highly controversial, field of human pesticide tests. Where mice and rats once stood in for people, human subjects increasingly are being used to establish just how big a pesticide dose they can withstand without harm.
The Scottish test, conducted last fall for Bayer Corp., a major pesticide manufacturer, involved volunteers who were paid about $750 to swallow Guthion, an insecticide used heavily on fruit crops. Bayer officials say the study showed no serious side effects in the subjects.
The test is one of many that chemical companies want the U.S. Environmental Protection Agency to rely on as it enforces a new federal law that raises standards protecting children from pesticides.
By using the tests, EPA officials would fundamentally alter the way safe levels of pesticides are set in the United States. Companies say the human testing will give the EPA an accurate look at how people react to pesticide exposures and guarantee that their products are not erroneously restricted.
But opponents say the tests are unethical and could undercut the protections for children the new law intends to introduce.
A special science advisory panel convened by the EPA to help decide the issue has drafted a report that could open the door to routine use of human lab tests in calculating pesticide risks to people, according to EPA records obtained by The Oregonian of Portland, Ore.
But in recent weeks, researchers and ethicists on the panel with grave concerns about the tests have sparked an uproar over the unreleased report. Half of the panel,s 16 members may call for a decision that places severe limits or prohibitions on the EPA,s use of the tests.
The verdict from the panel of toxicologists, statisticians, pediatricians and ethicists is critical to thousands of farmers and fruit growers, who fear the pesticides they rely on could be greatly restricted or canceled. "This is one of the most important questions we have faced on this issue, said Marcia Mulkey, director of the EPA,s Office of Pesticide Programs.
"We have not required these tests nor believe they are necessary. But if companies submit these tests anyway, you,re faced with the issue about what to do with them. We need an approach to evaluate both their validity and their ethics.
Opponents say the science behind the human pesticide tests falls far short of establishing safe pesticide levels.
"The new law could restrict many pesticides, and these tests are one way to undo the new safety margins, said Ken Cook, president of the Environmental Working Group, an advocacy organization that first drew attention to the tests last year.
"There,s no reason to believe we can make assumptions about the safety of these compounds, especially for children, because they have been tested on a few people in a lab.
But chemical companies and agriculture groups think the EPA,s endorsement of carefully constructed tests could eliminate the guesswork about how people react to certain pesticides.
Some researchers agree.
"If done in an ethical way, pesticides could be tested with human volunteers like any other chemical, said Dr. Ernest E. McConnell, a veterinary pathologist and toxicologist from Raleigh, N.C., and co-chairman of the EPA,s special panel. "If there are any chemicals that deserve to be studied in humans, it's pesticides. However, McConnell said opposition from environmental and consumer groups could sway EPA officials to look beyond the hard facts of the lab tests. "It should be science that drives the decision on human tests, not emotion, McConnell said. "What we're seeing now is some political science. Seeking guidance, EPA officials in December convened the special scientific panel of medical researchers and ethicists. It was originally scheduled to release a report in March. However, the panel,s inability to reach a consensus has delayed the EPA,s efforts to write a policy governing the tests.
CONCERNS EXPRESSED Some members hope the panel,s work expresses their concerns.
"There was a lot of alarm expressed on this panel about how these tests could be used, said Dr. Herb Needleman, a pediatrician at the University of Pittsburgh and a leading researcher on the effects of lead on children.
"There was widespread feeling these kinds of human studies should be done only in the most compelling of situations.
The focus on pesticides comes from the 1996 Food Quality Protection Act, passed unanimously by Congress and aimed at making sure the diets of children younger than 12 are better protected from pesticide residues.
The EPA measures the risk by weighing eating habits and pesticide residues on foods against the pesticide levels considered safe for human consumption.
Currently, these "safe levels are set through tests on animals. Researchers try to find how small an amount of pesticide can be ingested by lab animals such as mice, rats and dogs without showing ill effects.
If chemical companies can show people and animals do not react differently when exposed to pesticides, they could be allowed to increase the "safe dose by 10 times.
This change " effectively allowing 10 times more residue to remain on food " could be enough to pull some pesticides out of regulatory trouble.
"We do these tests as confirmatory studies after we have spent millions in animal testing, said Monty Eberhart, manager of product safety at Bayer,s agriculture division. "it's all leading us toward making the best decision we can possibly make to ensure people are kept safe.
But Dr. Chris Portier, a panel member from the National Institute of Environmental Health Sciences, said, "You could argue the only real benefit goes to the companies who are conducting them for the sole purpose of making money, not to any advancement of science.