Human Pesticide Tests Halted

The Bush administration announced Friday a temporary ban on the use of human tests for setting pesticide regulations and asked the National Academy of Sciences to review the scientific and ethical implications of intentionally exposing people to the toxic chemicals.

The moratorium comes as the Environmental Protection Agency is completing its first assessment of the cumulative health effects of certain pesticides and is in the midst of re-registering scores of pesticides to ensure their safety for children.

Pesticide companies have been funding clinical studies that expose paid volunteers to pesticides and then submitting the data to the EPA to persuade regulators not to further restrict applications of the widely used chemicals.

“Our paramount concern in developing our policy on these studies must be the protection of human health and adherence to the most rigorous ethical and scientific standards,” EPA Administrator Christie Whitman said.

As recently as a few weeks ago, the Bush administration had considered data from human tests when it re-registered several pesticides commonly used on a wide range of produce, grain and other crops. The administration told pesticide companies that it would continue to do so.

That reversed the Clinton administration’s informal moratorium on such tests. It also appeared to disregard recommendations of a scientific panel, assembled by the agency in late 1998, that human studies be used only in rare cases, if ever.

Whitman’s announcement came less than three weeks after The Times reported that the Bush administration had quietly abandoned the moratorium.

h the press ferreting this out, it was going to happen,” said Erik Nelson, a senior attorney at the Natural Resources Defense Council. “They recognize that the public is disgusted by these tests, and they recognize that the tests are scientifically severely flawed and have serious ethical problems.”

Environmentalists called the announcement a positive step but said the administration should have banned the practice outright.

“If industry cares so much about understanding the long-term effects and short-term effects of pesticides on humans, they should study farm workers more,” said Richard Wiles, a vice president of the Environmental Research Group, a Washington-based organization. Studies of farm workers and their children, Wiles said, could show what happens when people are exposed to the toxic chemicals.

Pesticide companies instead have been sponsoring clinical tests on volunteers in an effort to prove that the pesticides are no more harmful to humans than they are to laboratory animals. The goal is to persuade regulators not to apply a safety factor--a multiplier that uses the results of animal testing and multiplies that exposure level by 10--to establish an exposure level considered safe for humans.

Most of the human tests are conducted with a small number of healthy volunteers, and critics charge that they show nothing about the real risks of ingesting pesticides, especially for children and other vulnerable populations.

“They don’t really want to know the health effects,” Wiles said.

The pesticide industry blasted the EPA’s decision, saying that it could so restrict the use of pesticides as to hurt the livelihoods of American farmers, who must compete with foreign growers not subject to the same stiff regulations.

“It has the potential of dramatically reducing the number of tools that the farmer has for controlling insects,” said Jay Vroom, president of the American Crop Protection Assn., the trade group for pesticide companies.

Vroom said his industry will likely sue the EPA to end the moratorium, saying the ban would significantly affect the EPA’s cumulative risk assessment of a group of pesticides called organophosphates.

As a result of that assessment, which is scheduled to be completed next year, the EPA could further restrict the use of a number of pesticides now commonly used on a variety of vegetables and fruits.

“To do that without the full scientific body of evidence--including human studies--is likely to cause very serious over statements of the risks” of the pesticides, Vroom said.

But Steve Johnson, the assistant EPA administrator in charge of pesticides, said he is confident that the agency can do its job without the human test data.

“We believe that we have a more than sufficient database, through use of animal studies, to make licensing decisions that meet the standard--to protect the health of the public--without using human studies,” Johnson said.

Congress mandated the study of organophosphates and the reassessment of thousands of pesticides’ exposure levels to ensure safety for children as part of the 1996 Food Quality Protection Act.

Studies show that pesticides can cause birth defects, nerve damage, cancer and other health problems.

Children face a higher risk from pesticides because their brains and bodies are still developing and because, relative to their weight, they often eat more fruits, vegetables and other treated food than adults.