Pesticide Companies Using Humans in Lab Studies
A New Strategy to Gain U.S. Approval for Insecticides
Washington, D.C., July 27, 1998 -- For decades, U.S. and foreign pesticide manufacturers have been feeding their products to rats, rabbits, mice, and guinea pigs in thousands of controlled laboratory studies, all designed to satisfy government regulatory requirements for chemicals that kill weeds, insects, rodents and other pests.
Studies on lab animals are still routinely conducted for pesticides today. But in recent years, in a growing number of experiments that are raising ethical and scientific questions inside and outside government, the test animals are people.
And for reasons neither U.S. nor British environmental officials can explain, most of the recent human pesticide experiments are being performed in England and Scotland. Four have been submitted to the U.S. Environmental Protection Agency (EPA) since 1992, and EPA regulators believe that more are underway in the U.K.
Just last year, Amvac Chemical Corporation, a California pesticide company, hired a lab in England to conduct three related feeding trials using people to test the toxicity of a bug killer, dichlorvos, a common ingredient in pet collars and pest strips. Also, paid volunteer subjects drank doses of the extremely toxic insecticide aldicarb in a 1992 study in Scotland commissioned by Rhone-Poulenc, the French chemical giant.
Neither EPA nor UK pesticide guidelines require human studies. EPA officials informally discourage such studies on ethical and scientific grounds, refusing even to review study methods beforehand. EPA, in fact, has no policies or oversight system in place to insure that humans involved in such experiments are protected.
But the agency is nonetheless accepting human experimental studies submitted by pesticide companies, several of which have been used in at least two recent cases to soften EPA regulatory decisions.
The growing use of human testing to solve U.S. regulatory problems was revealed in a new report from the Environmental Working Group, entitled "The English Patients: Human Experiments and Pesticide Policy."
In effect, by substituting people for lab rats, pesticide companies have been able to increase the amounts of pesticide that legally could be used on crops, or be detected on foods, in water, or in air. That is why more studies are underway in the U.K., according to EPA scientists, though they do not know how many, where they are being conducted, or for what pesticides.
"Pesticide companies have a huge financial incentive to test people instead of other animals. They know that U.S. regulations on pesticides are finally being tightened. Human tests enable chemical companies to eliminate safety factors that have long been applied when nonhuman animals are used for testing," said EWG president Ken Cook, the report's author. "Some companies have decided to relieve regulatory pressure on their bug killers in the United States by dosing up human subjects in the United Kingdom," Cook said.
"We know from recent experience in medical research that human experimental subjects often do not really understand the implications of their decision to participate and that the oversight system is inadequate," Cook added, referring to a number of studies over the past few years by government inspectors in the United States.
"These pesticide experiments are being conducted on humans abroad, then accepted by the U.S. government in the absence of specific EPA regulations or monitoring capacity for human research. These companies are not testing medicines on people to see if they are therapeutic. They're testing toxic chemicals to see how high exposure can be without causing regulatory problems. No one ever benefits from being exposed to pesticides, " Cook said.
Citing ethical and scientific concerns, EWG said it strongly opposes human experiments that deliberately expose people to pesticides or other environmental toxins for the purpose of determining "safe" or "acceptable" levels of pollution for people.
"Allowing human experiments, such as those conducted recently in the United Kingdom, to serve as the basis for registering pesticides, is ethically indefensible," Cook said.
"Poor science involving humans is itself unethical," he noted. "We question whether short-term feeding studies, conducted on a handful of healthy adults, can form the basis of any assurance that pesticides are safe for tens of millions of infants and children, as U.S. law now requires," Cook added.
EWG is asking EPA to conduct a comprehensive study of the use of human subjects in past and recent environmental research, modeled after the landmark 1995 Presidential Advisory Committee on Human Radiation Experiments. Once the study is completed, EWG says, the EPA should issue policy and guidelines for public comment on the use of humans in environmental research. The rules must provide for thorough monitoring, EWG said, including consideration of special ethical considerations that distinguish human research on toxic contaminants from human research for drugs and medicines.
EWG also recommended an immediate moratorium on human experimentation, of the type conducted for dichlorvos, aldicarb, and perhaps other pesticides, for purposes of pesticide regulation. The group also asked EPA to suspend any pesticide approvals if the agency is unable affirmatively to determine that the studies were conducted according to U.S. ethical standards.