Regulation of genetically engineered microorganisms under FIFRA, FFDCA and TSCA

Abstract

Since the dawn of civilization, humans have utilized microbial organisms of various sorts for food and agricultural production. More recently, microbes have been used for pesticidal, and environmental management purposes. With the advent of the development of recombinant DNA technology to genetically alter microbes, it became necessary for Federal regulators to assess the appropriate level, format, and application of their regulatory authorities. In 1986, the Office of Science and Technology Policy issued the Coordinated Framework for Regulation of Biotechnology. The Coordinated Framework constituted a comprehensive regulatory policy for biotechnology that, in essence, concluded that no new statutory authorities were necessary to effectuate a robust and efficient regulatory program for the products of biotechnology. The Framework articulated a division of regulatory responsibilities for the various agencies then involved with agricultural, food, and pesticidal products. Thus, in accordance with the Framework, USDA APHIS regulates microbes that are plant pests under the Plant Protection Act (PPA) and the National Environmental Policy Act (NEPA); the U.S. Environmental Protection Agency (U.S. EPA) regulates microorganisms and other genetically engineered constructs intended for pesticidal purposes and subject to the Federal Insecticide Fungicide and Rodenticide Act (FIFRA) and the Federal Food Drug and Cosmetic Act (FFDCA). The U.S. EPA also regulates certain genetically engineered microorganisms used as biofertilizers, bioremediation agents, and for the production of various industrial compounds including biofuels under the Toxic Substances Control Act (TSCA). The focus of this chapter is the regulatory process for approval of the use of genetically engineered microbes under the oversight of the U.S. EPA. We will also consider instances where organisms may be exempted from oversight and the outlook for the application of GE microbes in the future. This chapter does not seek to serve as a guidebook for navigating the details of the regulatory process, but rather as an overview of key considerations in risk assessment and risk management.