The Impact of Toxicological Standards on Governance

Harvard University, Cambridge MA

Investigators

Abstract

This historical study examines how toxicologists and regulators developed Good Laboratory Practice (GLP) regulations to ensure the reliability of toxicology data supporting drug and chemical regulation and trade. The study?s central goal is to understand how toxicological data have traveled out of the laboratory and across political jurisdictions. The study traces how GLP rules that initially crafted to resolve a crisis in toxicology were used to regulate domestic and international chemical testing and trade. This study will contribute to our understanding of the interaction of trade and public health regulations. This study will help to evaluate impacts on public health and develop more effective policies. This study seeks to understand how and why GLP was developed in the U.S., and why GLP appeared to OECD states to be a good solution to the problem of regulatory harmonization and facilitation of international trade. It asks how a particular way of doing laboratory work was rendered authoritative, and what consequences this has had in governmental efforts to control chemicals. The investigators will analyze archival records and published documents from regulatory agencies, toxicologists, and international standard-setting bodies, and conduct oral histories with participants. Findings from the study will inform the literature in the field of STS on the history of toxicology and risk analysis, the development of regulatory policies, and values in science.