Recommendations Regarding Ethics of Pesticide Testing in Humans

Newswise — The recommendations address any research that the U.S. Environmental Protection Agency (EPA) sponsors, conducts, and/or accepts in pesticide registration applications. Pesticide manufacturers have tested pesticides in small groups of human volunteers over the past decade and submitted the results to the U.S. EPA for consideration in standard setting.

The expert panel gathered in February 2002 at the Mount Sinai School of Medicine and continued their dialogue for six months afterwards, resulting in today's recommendations.

The authors note that federal health agencies such as the National Institutes of Health and the U.S. Food and Drug Administration have rules governing the ethics and scientific quality of studies submitted for research purposes—the so called Common Rule—but that the U.S. EPA has no such guidelines.

Under the panel's 12 recommendations, any study involving the administration of pesticides to humans must be supervised by a qualified physician; studies must include a sufficient number of subjects to provide statistically valid answers to the questions under investigation; research on animals must precede research on humans; and any human study involving risks that would be unacceptable in a developed nation may not be conducted in a developing nation. Also, under no circumstances are pesticides to be administered to children.

The lead author of the study was Christopher Oleskey of the Mount Sinai School of Medicine. Other authors were Alan Fleischman, Lynn Goldman, Kurt Hirschhorn, Philip J. Landrigan, Marc Lappé, Mary Faith Marshall, Herbert Needleman, Rosamond Rhodes, and Michael McCally.

EHP is published by the National Institute of Environmental Health Sciences, part of the U.S. Department of Health and Human Services. More information, including the full report and the complete list of expert panelists, is available online at http://www.ehponline.org/.