The new EPA regulations on protecting human subjects: haste makes waste.

• Author: Resnick, David B.
• Position: Reprint

HASTINGS CENTER REP., Jan./Feb. 2007, at 17.

The Environmental Protection Agency's new regulations for research on human subjects, adopted in 2006, mark the culmination of a vociferous, eight-year debate between environmental and industry groups concerning pesticide testing on human subjects. The storm began in 1998 with the publication of a report titled "The English Patients" by the Environmental Working Group, which described privately funded studies on the effects of intentionally exposing human subjects to pesticides. Pesticide companies were sponsoring the studies in response to the Food Qualifty Protection Act (FQPA), which Congress had passed in 1996. Prior to 1996, the EPA determined the allowable human exposure to pesticides found on foods by performing a simple mathematical calculation on the "no observable adverse effect level" (NOAEL), which applies to rodents and is established by research. First, the EPA divided the NOAEL by a "safety factor" of ten, which it called the "rodent-human safety factor," so that the average human would get only one-tenth the exposure to pesticides that rodents can tolerate. Then it divided this result by ten again--a "human variation safety factor"--on the theory that some humans might be much more sensitive to pesticides than others, so that the actual human exposure would only be one-tenth that which the average human should be able to tolerate. The FQPA then required the EPA to divide this result by ten once more--the "adult-child safety factor"--to provide yet another layer of protection for children. Ultimately, then, the allowable human exposure would be one-one thousandth of the level that had been shown not to have any observable effects in rodents.

The pesticide companies planned to submit their data on human pesticide exposure to the EPA as part of an effort to avoid the more stringent restrictions imposed by the FQPA. The Environmental Working Group argued, however, that the studies were scientifically and ethically flawed and that the EPA did not have any detailed regulations concerning human research conducted by private companies. Instead, it had a policy that human exposure experiments conducted by third parties would be evaluated on a case-by-case basis, by applying the federal Common Rule and other statutory and ethical requirements. The agency had already adopted the Common Rule for EPA research and EPA-sponsored research, but had not formally adopted it for third party research...