U.S. Environmental Protection Agency


Date of this Version



C.A. Wozniak and A. McHughen (eds.), Regulation of Agricultural Biotechnology: 1 The United States and Canada, DOI 10.1007/978-94-007-2156-2_1


This article is a U.S. government work, and is not subject to copyright in the United States.


The regulation of agricultural plant and microbial biotechnology products in the United States of America has a rich history that re fl ects the challenges the federal government has faced in the development of appropriate rules and standards needed to determine their safety to humans and the environment. Several factors – the insuf fi cient global food supply, loss or curtailment of the use of older chemistries to control pests due to risks and environmental persistence, the rising demand for safer food commodities, and the uncertainty surrounding the sustainability of agriculture in this and other countries – have added to these challenges. The chapter introduces the U.S. Coordinated Framework for the Regulation of Biotechnology (“Framework”), and the roles of its members: the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) in regulating agricultural biotechnology in accordance with U.S. federal statutes. The Framework agencies use scienti fi c, risk-based approaches in carrying out their regulatory responsibilities for the products of biotechnology. Relying on their experiences with risk assessment and risk management policies and principles for more conventional products, the Framework agencies have adapted new risk and exposure scenarios into their evaluations to ensure the safe use of these products in agriculture.