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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues
cultural pesticides, for example, contribute to our abundant, safe, and relatively inexpensive food supply. Chemicals are used to produce a vast array of other consumer products from which people directly benefit. They also enter the environment as by-products of activities people value, such as the burning of gasoline and other fuels for transportation and the production of electricity for heating and lighting our homes. No one wants the chemical by-products that can pollute the air and water and contaminate food, but few are prepared to do without the relatively low-cost energy that makes life comfortable and convenient. The controversy that stems from the two-sided nature of the use of most chemicals often is intensified by disputes among commercial interests, environmental groups, and others with diverse points of view about the proper assessment, balancing, and allocation of the associated risks and benefits. EPA’s chemical regulatory programs operate at the intersection of these competing interests and values. The agency administers a series of congressional enactments that establish basic standards and procedures for assessing and balancing the risks and benefits of the use of chemicals through the regulatory process. These statutes resolve some of the broader questions about how particular categories of chemicals are to be regulated, but they leave many controversial issues unresolved. Some of the most important issues with which EPA must grapple on a continuing basis involve the nature of the scientific evidence that will serve as the basis for regulatory decision making.
EPA commissioned this study to help address a particularly vexing issue concerning the acceptability and usefulness of scientific evidence. The issue is whether and under what circumstances EPA should accept from outside parties, and consider in its regulatory decision making, studies that involve the intentional dosing of research volunteers in order to gather evidence relating to the risks of using a chemical or the conditions under which exposure to it could be judged safe.
This issue is one that is multifaceted and difficult. It involves the complex interplay between important ethical concerns and scientific questions regarding the validity and usefulness of human studies for EPA’s regulatory purposes. Like chemical regulation in general, the issue of human testing involves competing interests and values. And the issue has an emotional component. For many, the idea of testing pesticides and other industrial chemicals and chemical contaminants in humans is, on its face, repugnant. It is natural and appropriate to question whether and why such testing should be conducted and considered by EPA, especially when the study participants gain little or no direct benefit.3
This report uses the terms “participant” and “subject” to refer to persons who participate in research. The term “subject” has been widely used for decades and appears in the federal