News Coverage
Pesticide Industry Fights for Human Testing
Lawsuit challenges moratorium set by EPA
Published March 3, 2003
WASHINGTON -- Should the chemical industry be allowed to use human volunteers to test the toxicity of its pesticides?
That question is at the heart of a lawsuit to be argued this month in Washington. The industry seeks to overturn a government moratorium on human test data to evaluate the safety of chemicals used on crops to kill insects, rodents and other pests.
"It is unethical and immoral for the Environmental Protection Agency not to consider valid human testing ... when that data can contribute to improving certainty in assessing pesticide safety," said Jay Vroom, head of the CropLife America, the industry trade group that filed the federal lawsuit. "Pesticides are as beneficial to humans as are pharmaceuticals."
Environmental groups support the EPA moratorium, maintaining that human testing is unethical. They liken the industry studies to Nazi medical experiments, in which prisoners were fed doses of toxic chemicals.
"The pesticide industry and others have a long and often troubling history of dosing humans with toxic substances in flawed studies that may cause significant harm but result in no scientific gain," the Natural Resources Defense Counsel said in a legal brief. "Industry human tests promote profit over public health."
The EPA imposed the moratorium on using humans in pesticide tests in June 2000 during the final months of the Clinton administration. The ban was lifted under pressure from industry in early 2001 by Christie Whitman, President Bush's environmental administrator.
A backlash from environmental and health advocates led Whitman to reimpose the ban in December 2001 and ask the National Academy of Sciences to review the scientific and ethical implications of the human studies. That review is still in progress.
The controversy had its genesis with the 1996 passage of the Food Quality Protection Act, a law designed to protect children from harmful pesticide residues. The law called on the government to reconsider existing pesticide safety levels to reflect their impact on children. Studies have shown that pesticides cause birth defects, nerve damage, cancer and other health problems, and that children are at greater risk of harm than adults.
Under the previous pesticide law, the safety level for humans was calculated by determining the safe dose for a lab animal and then reducing it 100 times. The 1996 law required the EPA to set the safety level at one one-thousandth of the dose that a rat or dog could withstand.
The result was to reduce the levels of pesticides allowed for use on crops, or detected in foods, water and in the air. The government has since banned or restricted some of the uses of five of the most toxic pesticides. The chemical industry worries that many of its most profitable products could be threatened as the EPA continues its reassessment.
After passage of the 1996 law, some companies responded with a controversial strategy: They would feed low doses of pesticides to human volunteers to prove their chemicals are safe and can continue to be used at their pre-1996 safety levels.
Although human tests have been used periodically in the past and considered
in some pesticide evaluations by the EPA, environmental groups charged the law had led to an unexpected increase in such studies. The EPA said 20 human studies were conducted between the time the 1996 law was approved and the moratorium was imposed.
The Environmental Working Group, a nonprofit research organization that tracks pesticide issues, sparked the current debate with a report in the summer of 1998 providing details about some of the human testing of pesticide.
The report focused in part on Amvac Corp., a California company that hired a laboratory in England in 1997 to conduct three human studies on the insecticide DDVP, or dichlorvos, a nerve agent used to kills flies, mosquitoes, caterpillars and other insects.
The lab paid a small number of adult males about $600 each to ingest the insecticide over several weeks to test its acute effects, with the company maintaining that the lab fully informed the volunteers of the risks and followed all medical ethics.
Similar human tests on other pesticides were conducted in Scotland by Bayer Life Sciences in 1998 and in Nebraska in 1999 by Dow Agrosciences Ltd.
In the various studies, subjects were dosed with pesticides at various intervals either by taking a pill, by drinking fruit juice containing the toxin or through a dermal patch. The subjects then had periodic blood tests and were monitored for ill effects such as involuntary muscle twitching, vomiting, diarrhea, abdominal pain or blurred vision.
The Clinton administration responded to the reports of those tests by imposing the moratorium. Whitman lifted and then reinstituted the ban, prompting CorpLife America and a other companies, including Bayer and Amvac to file their lawsuit in the U.S. Court of Appeals for the District of Columbia. The case will be argued on March 17.
In his legal brief, CropLife attorney Kenneth Weinstein argues the EPA's moratorium was "a change in policy by fiat" that is procedurally flawed, illegal and must therefore be vacated.
Weinstein also said the refusal by the EPA to consider relevant and scientifically valid human data in re-evaluating pesticides, including studies done years ago, has "caused the agency to overstate dramatically the risks posed to humans by these pesticides." He said this has had "an enormous impact on the commercial viability of the products."
The EPA maintains the moratorium is not a formal regulation or a definitive policy that can be legally challenged or that is causing any immediate injury to pesticide manufacturers.
Instead, the agency said the moratorium is an interim step pending a scientific review. It argued in court papers that the law does not require it to consider, use or rely on any human studies of pesticide toxicity.
The NRDC went further, offering affidavits from scientists challenging the validity of some of the industry studies submitted to the EPA.
Those affidavits by expert witnesses claim volunteers in some cases were not fully informed of the risks, that the studies involved samples too small to be scientifically valid, and that adverse reactions to volunteers including "serious side effects demonstrating neurological harm" were improperly discounted by the companies.
