Rule Proposed for Human Testing

EPA has finally proposed regulations to govern the use of humans to test the toxicity of pesticides. Unlike an earlier draft rule leaked last month, the completed proposal prohibits the intentional dosing of pregnant women and children to set pesticide standards. It also requires that an independent oversight panel--a Human Studies Review Board--be set up to ensure that any human exposure studies submitted to EPA are conducted ethically. The rule requires that all potential risks be disclosed to study participants. For new intentional dosing studies, researchers must comply with the so-called Common Rule--current ethical standards for research conducted by the federal government--and submit detailed study protocols to EPA before a test is begun. There are several loopholes in the new rule, however. The proposal would allow researchers to use data from everyday or unintentional exposure of pregnant women and children. And it does not prohibit EPA from looking at the results of earlier studies that do not meet the new standards. After a 90-day public comment period, the rule is scheduled to take effect on Jan. 29, 2006. More information is available at www.epa.gov/oppfead1/guidance/human-test.htm.