Human Testing Lawsuit Update

In February, PAN joined a coalition of health and environmental advocates, farm workers and doctors, in filing suit in the U.S. Court of Appeals for the Second Circuit against U.S. EPA over its new rule on intentional dosing of human beings with pesticides.* We are arguing that EPA’s new rule violates a law passed by Congress in 2005 mandating strict ethical and scientific protections for research subjects.

Although the EPA rule prohibits certain kinds of testing and limits others, it is riddled with loopholes and ultimately encourages more human testing. For example, the rule restricts experiments on pregnant women and children only where the researcher “intended” to submit the research to EPA; research not covered by this intent requirement is not barred. The rule also fails to ensure that pesticide testing on human subjects meets the most stringent standards recommended by a 2004 National Academy of Sciences report and outlined in the Nuremberg Code after World War II. Unions representing EPA staff scientists oppose the rule, and have charged pesticide industry influence in creating the rule.

Pesticide manufacturers—who are the advocates for human testing—concede that their interests are to weaken safety standards by circumventing EPA’s current margin of safety based on animal studies, which is used to estimate a “safe” human exposure level of pesticides. Human testing studies considered by EPA in recent years have presented serious violations of ethical and scientific standards. For example, one company misinformed participants in a test, telling them they were eating vitamins, not toxic pesticides. In many other tests, companies were irresponsible in not providing any long-term follow-up to protect participants’ health, despite the fact that long-term health effects of pesticide exposure can be very serious.

In a scathing June 2005 report, entitled “Human Pesticide Experiments,” Senator Barbara Boxer and Representative Henry A. Waxman showed that twenty-two pesticide experiments submitted to EPA for possible use in regulatory decision-making were in violation of ethical standards—including failure to obtain consent and the dismissal of adverse outcomes.

EPA’s initial response to the suit was to seek dismissal from the U.S. Court of Appeals, arguing that the groups filing the suit were not legitimate representatives of those affected by pesticide testing. Yet the groups are nationally known organizations representing farmworkers, public health and environmental concerns and hence are appropriate representatives for the potential victims of human testing of pesticides. Victims of pesticide testing, often not informed about the chemicals being tested on them and sometimes led to believe that they were participating in drug trials, are rarely in a position to challenge EPA over allowing such practices.

In mid-September 2006 the Federal Court ruled that the case could move forward. However, we expect that EPA will once again attempt to have the case dismissed. As we went to press, the following members of Congress had signed a petition in opposition to the rule allowing intentional dosing of pregnant women and children—Senator Barbara Boxer (D-CA), Senator Bill Nelson (D-FL), and Representative Hilda Solis (D-CA).