FDA, OSHA, and EPA Regulation of the Recombinant DNA Technology

Abstract

The extent of existing federal authority over commercial applications of the recombinant DNA method is an important question, since this biotechnology increasingly becomes the subject of industrialization. This article examines the statutory authority of three agencies—the Food and Drug Administration, the Occupational Safety and Health Administration, and the Environmental Protection Agency—to regulate the recombinant DNA method both in the workplace and as a new method of manufacture of chemicals, particularly drugs. These agencies have extensive powers to regulate the manufacture and distribution of products made by the recombinant DNA technique under the Federal Food, Drug, and Cosmetic Act, the Occupational Safety and Health Act, and the Toxic Substances Control Act.