Biography

Angela N. H. Creager is the Thomas M. Siebel Professor in the History of Science at Princeton University, where she writes and teaches on the history of biology and biomedical research. She has published two monographs and is currently working on a third on science and regulation in the 1960s through the 1980s. She is the coeditor of four volumes, most recently Risk on the Table: Food Production, Health, and the Environment (2021), with Jean-Paul Gaudillière.

Abstract

"Forms of Life or Chemicals?  Microbes and the US Regulation of Biotechnology"      

In the 1970s and 1980s, microbes played a key role in the development of genetic engineering and its commercialization in biotechnology. In fact, microbes were also being used to produce various drugs and supplements, such as antibiotics and vitamins, so recombinant DNA technologies represented a change in scale and possibility for harnessing the productive power of single-celled organisms. The Diamond vs. Chakrabarty ruling by the US Supreme Court in 1980 permitted the patenting of organisms, beginning with bacteria. At the regulatory level, too, genetically modified organisms were subjected to existing laws for insuring safety of products. This paper examines how the Toxic Substances Control Act of 1976, which regulated commercial chemicals, was extended to include new strains of microbes being developed to produce drugs and other materials. Although it seems counterintuitive to regard genetically engineered bacteria as chemicals, oversight of their safety was intended to support the American biotech industry.