U.S. Will Use Once-Banned Human Tests

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.

Now the Bush administration, siding with manufacturers on whether such studies are ethical and scientifically valid, has told the pesticide industry it will use data from such tests, in which paid volunteers swallow small doses of the products.

The new policy, which the Environmental Protection Agency has not announced, also appears to disregard the recommendations of a scientific panel the agency assembled in late 1998.

Two panel members called for a ban on human testing of pesticides, while the 16 others said such tests must be very limited. The panel of doctors, bioethicists and clinical scientists 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. There should be a very high threshold,” said 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 about 9,000 pesticide safety levels to reflect their impact on children. In general, children can tolerate smaller amounts of pesticides, medicines and other substances than adults.

Federal regulators determine the amount of certain pesticides that people can tolerate on foods, in water and in agricultural jobs without harming their health. Too much exposure can result in neurological damage, cancer or other serious illnesses.

Though details of the new policy are unclear, industry officials welcome the shift. 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. The companies argue that human tests provide more accurate results, allowing pesticides to be applied to crops in larger quantities and closer to delivery to supermarkets.

Without human tests, regulations “end up being more conservative and more restrictive than they need to be,” said 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,” he said. “There are secondary public health consequences if you don’t have good crop protection.”

Industry officials also noted that human volunteers are regularly used to test the effects of air pollution.

The administration first signaled the policy switch last month, when a top EPA official told the annual meeting of the American Crop Protection Assn. that the agency would consider the results of clinical tests on humans.

Assistant Administrator Stephen L. Johnson “indicated the agency would be looking at the human data that were submitted,” McAllister said.

Also, documents on at least three pesticides submitted to the EPA in recent weeks for re-registration plainly state that the agency is considering data from tests on humans. The re-registration is mandated by the 1996 Food Quality Protection Act, which requires the EPA to reassess 9,000 currently registered pesticides for their impact on children.

An EPA official, speaking on the condition of anonymity, confirmed Johnson’s remarks to the trade group, and other EPA officials acknowledged that the administration is developing a new policy on human testing of pesticides. But officials said they did not have approval from top political appointees to talk about it.

In its 10-month tenure, the Bush administration has weakened an array of Clinton administration environmental regulations and proposals, agreeing with industry and angering environmentalists. The rollbacks range from loosening energy efficiency standards for air conditioners to erasing a provision that would have allowed federal land managers to reject certain types of mines if they would cause irreparable damage to public land.

The administration also halted the implementation of new, stricter standards for arsenic in drinking water. After conducting its own tests, and under pressure from Congress, the EPA announced last month that it would adopt the Clinton administration standard.

In the decade before 1996, when the law requiring retesting of pesticides was passed, the EPA received only a handful of human tests. In the three years that followed, the agency received 14 new, unsolicited human subject studies on 10 pesticides.

The controversy over human testing of pesticides erupted in 1998, when Environmental Working Group, a Washington-based investigative environmental organization, published a report on the plethora of human test results arriving at the EPA for pesticide evaluations.

Then-EPA Administrator Carol Browner harshly criticized the practice, launched the study and temporarily halted the use of such data. The moratorium deterred companies from sponsoring and submitting results from such tests. But because the Clinton administration never formalized the policy, Bush administration regulators could change their practices without a new formal policy.

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 said.

But the EPA panel of scientists found 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.

The panel suggested that at least some human subject tests used by the EPA in the past had not met the demands of good science, saying that “bad science is always unethical.” Panel members were concerned, for example, that previous human tests were too small to assess the risks of pesticide exposure to the broader population or to more vulnerable individuals.

Human testing of pesticides cannot be justified “to facilitate the interests of industry or of agriculture,” the panel concluded in its final report, delivered in February 2000. Such studies are acceptable only if they “promise reasonable health benefits to the individual or society at large,” it said.

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.

Panel members were concerned that human testing of pesticides could become widespread, especially because the 1996 law required the EPA to give closer scrutiny to pesticides originally registered before 1984.

Recent documents regarding the pesticides phosmet, azinphos-methyl and chlorpyrifos--insecticides used on a wide variety of fruits and vegetables--show that the EPA is evaluating data from human tests as well as a variety of tests on laboratory animals to determine exposure levels.

Pesticide manufacturers want to use human tests to reduce or eliminate regulators’ current assessment method: determining safe exposure levels for laboratory animals and then multiplying that risk factor by 10 to ensure safety for humans.

In the midst of the dispute over federal policy, California’s Department of Pesticide Regulation drafted its own policy on human testing. The state agency considers human test data if the tests were conducted under specific ethical and scientific guidelines.

The state agency has considered two or three human-subject tests over the last five years, according to Glenn Brank, spokesman for California’s Department of Pesticide Regulation. One such test, for the azinphos-methyl, persuaded regulators that humans and animals respond in the same way to the toxins in the pesticide.

As a result, the agency allowed growers of apricots and other pitted fruits to apply the pesticide closer to harvest time, Brank said.

Lynn Goldman, who headed the pesticide program at EPA for five years during the Clinton administration, opposes the use of human subject tests and strongly believes that EPA can safely regulate pesticides with tests on animals.

She said 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 pharmaceutical. The only justification for conducting the tests is to make more money for the pharmaceutical companies, she said.

“If they were doing something to benefit us you might look at it differently,” said Goldman, now a professor of environmental sciences at Johns Hopkins University. “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.”

Goldman also finds it disturbing that test subjects are given money to take the pesticide tablets, saying that encourages students and low-income individuals to participate.

Goldman said she believed that pressure from the industry prevented the Clinton administration from finalizing a policy governing human testing.

“When it came to new regulations or new policies like this one--and especially around the Food Quality Protection Act that had such a major impact on the world--we had a whole lot of push-back through the White House from industry, and a lot of it would come at us from Congress,” she said.