Pesticide testing in humans: ethics and public policy.

Abstract

Pesticide manufacturers have tested pesticides increasingly in human volunteers over the past decade. The apparent goal of these human studies is to establish threshold levels for symptoms, termed "no observed effect levels." Data from these studies have been submitted to the U.S. Environmental Protection Agency (EPA) for consideration in standard setting. There are no required ethical guidelines for studies of pesticides toxicity conducted in humans, no governmental oversight is exercised, and no procedures have been put in place for the protection of human subjects. To examine ethical and policy issues involved in the testing of pesticides in humans and the use of human data in standard setting, in February 2002 the Center for Children's Health and the Environment of the Mount Sinai School of Medicine convened an expert workshop for ethicists, physicians, toxicologists, and policy analysts. After a peer consensus process, participants developed a number of ethical and public policy recommendations regarding the testing of pesticides in humans. Participants also strongly encouraged active biomonitoring of every pesticide currently in use to track human exposure, particularly in vulnerable populations, and to assess adverse effects on health.

Basic Elements of Toxicology

“…At an expert workshop held during 2002 in New York it was noted that even at that time there were no general ethical guidelines for studies of pesticide toxicity conducted in humans and no governmental oversight. The participants developed several ethical and public policy recommendations regarding human testing of pesticides (Oleskey et al, 2004).…”

Safety in Human Research: Past Problems and Current Challenges from a Canadian Perspective

“…There currently are no formal guidelines and requirements for ethical conduct in research carried out by private companies. Such companies can provide data to the Environmental Protection Agency (EPA) without adherence to the established ethical standards of research (Oleskey, 2004).…”

Scientific Judgment and the Limits of Conflict-of-Interest Policies

“…All these strategies are designed to minimize false positive results while increasing false negatives. For example, in an analysis of ethical and scientific issues associated with industry studies of pesticides on human subjects, the EPA Science Advisory Board found that the industry studies invariably involved sample sizes that were dramatically too small, allowing for huge rates of false negatives (Oleskey et al, 2004).…”