Three years ago, in response to mounting criticism from environmentalists and physicians, the Clinton administration stopped using information from industry studies conducted on humans to determine the amount of pesticides that could be applied to fruits, vegetables and other crops.
This is related to the problem that physicians have had since World War II, when deciding whether or not to use the test results from Nazi doctors testing Jewish subjects in concentration camps. Since these tests cannot be duplicated, this is the only data available in many cases about the reaction of the human body to things like extreme cold.
Now the Bush administration has told the pesticide industry it will use data from such tests, in which volunteers were paid swallow small doses of the products. This is not the first time the U.S. government has engaged in human testing. Eileen Welsome, author of ?The Plutonium Files,? described a study on Dreamland in which hospital patients were unknowingly given plutonium to determine how humans would react to a nuclear attack.
A panel of doctors, bioethicists and clinical scientists have urged the EPA to adopt a clear policy on human testing, one that would require adherence to rigorous standards and pre-approval by an independent review board. ?The force of the report was, in general, that it shouldn?t be done,? says panel member Samuel Gorovitz, a professor of philosophy and public administration at Syracuse University.
The new policy could have a significant impact because it comes as the government is beginning to reassess the safety levels of about 9,000 pesticides to reflect their impact on children. In general, children can tolerate smaller amounts of pesticides than adults. Too much exposure can result in neurological damage, cancer or other serious illnesses.
Without human tests, the government uses the results of animal testing and multiplies that exposure level by 10 to establish an exposure level considered safe for humans. Manufacturers say that human tests provide more accurate results, allowing pesticides to be applied to crops in larger quantities, closer to harvest time.
Without human tests, regulations ?end up being more conservative and more restrictive than they need to be,? says Ray McAllister, vice president for science and regulatory affairs for the pesticide trade association. If human subjects are not used, ?you may be denying benefits not only to the grower producing the crop but also to society that needs the food at a reasonable price. There are secondary public health consequences if you don?t have good crop protection.? Industry officials note that human volunteers are regularly used to test the effects of air pollution.
The majority of human studies considered by the EPA in the past were conducted in other countries. But in 1999, 60 volunteers in Nebraska participated in a test of a pesticide called chlorpyrifos, which is marketed as Lorsban or Dursban. It has been used for 30 years to keep insects off most major crops grown in the United States.
The volunteers were paid $460. Some of them swallowed chlorpyrifos-laced tablets, while others took placebos. Some members of both groups experienced headaches or vomiting. Garry Hamlin, spokesman for chlorpyrifos manufacturer Dow AgroSciences, said the results of his company?s tests showed no signs of toxicity from the pesticide.
?The clinical test was a way of bridging the gap from a considerable amount of existing data that would help us understand how this product functioned in the human body, how the body metabolized it and how quickly it excreted it,? he says.
But the EPA panel of scientists says that human testing is almost never needed for pesticides already in use because studies are already available of agriculture workers and fruit and vegetable eaters who have been exposed to the pesticides. Human studies could be appropriate for new pesticides, the panel concluded, if there was no way to protect human health by testing on rats, dogs and other laboratory animals.
Lynn Goldman, who headed the pesticide program at the EPA for five years during the Clinton administration, says she is ?very troubled? by the use of human testing for pesticides, because there is no possible healthful effect from taking a pesticide-laced tablet, as there usually is for testing a drug. The only justification for conducting the tests is to make more money for big business. She also finds it disturbing that test subjects are given money to take the pesticide tablets, because that encourages students and low-income individuals to participate.
?If they were doing something to benefit us you might look at it differently,? says Goldman. ?For industry, there is an enormous amount of money in the balance; one study could make the difference of tens of millions of dollars. That?s one of the troubling ethical issues.?
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