Air Date: Week of December 7, 2001

Under the Clinton Administration, the Environmental Protection Agency refused to consider results of pesticide testing done on humans. Now, the Bush Administration is taking a second look at this restriction. Living on Earth's Anna Solomon-Greenbaum reports on the controversy.

Transcript

CURWOOD: This is Living on Earth. I'm Steve Curwood. The U.S. Environmental Protection Agency is expected soon to approve the testing of pesticides on humans. The move would reverse rules adopted under the Clinton Administration. The EPA had been refusing to accept data from human studies conducted by the pesticide industry, citing ethical concerns. But chemical manufacturers say, in some cases, carefully monitored human tests can safely provide the most accurate assessment of toxicity. Living on Earth's Anna Solomon-Greenbaum has our story from Washington.

SOLOMON-GREENBAUM: In 1998, the Environmental Protection Agency convened a special panel of scientists. Their directive: to advise the agency on whether and how it should use data from pesticide testing done on human subjects. The panel concluded that such data could be permitted if the results could not be obtained through any other methods, such as animal testing, and if stringent ethical guidelines were followed, and, of course, the science must be sound. Dr. Art Caplan directs the Center for Bioethics at the University of Pennsylvania. He was one of the scientists on the panel. He and his colleagues reviewed a handful of human pesticide studies submitted to the EPA by pesticide companies. What they found, says Caplan, was simply bad science.

CAPLAN: For one very simple reason: there aren't a lot of subjects. Even if you pay a lot of money, there are not a lot of people who are going to step forward and say, "Okay, for 50 dollars, you can slightly poison me."

SOLOMON-GREENBAUM: Caplan says the statistical validity of such tests is further undermined by the fact that they almost never use pregnant women or children, the populations considered most vulnerable to pesticide exposure. Conventional medical studies have the potential to benefit the test subjects or others with the same disease. Pesticide testing in which people swallow pills containing a toxin offer no such promise. Those who volunteer, says Caplan, do so under pressure.

CAPLAN: Let's face it: the people involved in pesticide testing are either poor and vulnerable, or students who are desperate for money. Once in a while, there are people who come out of the companies who are the employees. In every case, their ability to give informed consent and their ability to kind of protect their own interests is somewhat suspect.

SOLOMON-GREENBAUM: Many environmental groups would go further. They condemn human testing of pesticides under any circumstance, and warn that allowing the considering of human data will open up a floodgate and encourage the chemical industry to do more human tests. Two members of the EPA science panel also denounced any sort of human testing of pesticides. Dr. Caplan was not a member of that minority but he recalls the panel's deliberations as some of the most difficult of his career.

CAPLAN: I know we hear about cloning and stem cells and many, many other controversial issues, but this one was really rough, really divided the members, and came under extraordinary pressure from industry and environmental groups--everybody kind of watching what this panel was going to do.

SOLOMON-GREENBAUM: In 1996, the Food Quality Protection Act required the EPA to reassess safety levels for over 9,000 pesticide uses. Most tests are performed on animals, then the EPA applies an extra 10 fold safety factor to those results to arrive at a safe dose--that is, the maximum amount which does not produce a measurable chemical change in the body. But, when pesticides are tested directly on humans, the safe dose is generally found to be higher. So, going by those results would usually increase the amount of allowable pesticides.

As the EPA undertook its sweeping pesticide review, officials saw a significant increase in the number of human studies sent in by pesticide companies. Jay Vroom, president of the American Crop Protection Association, the leading pesticide trade group, explains why.

VROOM: Now, under the tougher scrutiny that our industry products are facing in review and new product approvals, we need more and more science, including, on occasion, the ability to use and reference human clinical trials done in an ethical manner, to refine and be more precise about what we know about the safety of these products.

SOLOMON-GREENBAUM: Vroom says it's not just industry interests at stake. Without human testing, he says the limits on certain pesticide uses could be set too low. That would hurt farmers, and the public, as well.

VROOM: We could lose a massive amount of the entire class of insecticide products that farmers depend on, and, if we're doing that for no real scientific risk elimination, then we're hurting our economy.

SOLOMON-GREENBAUM: Meaning, the U.S. Government may unnecessarily deny American farmers the ability to compete with foreign growers who are allowed the use of these chemicals. Along with other industry lobbyists, Vroom has met to discuss human testing with senior EPA officials on several occasions. Those officials refused requests to be interviewed for this story. The agency has not yet issued a formal policy on whether and how it will use human testing results in its pesticides review, but it has used data from three human studies this year. The EPA expects to come out with a policy proposal on human testing of pesticides in January. A public comment period will follow. It's sure to be contentious, but those familiar with the human testing debate say it's not simply about ethics or statistical validity as it appears. The broader political issue looming over this dispute is a more basic one, about the safety of using any pesticides on our crops. For Living on Earth, I'm Anna Solomon-Greenbaum, in Washington.