Genetic Engineering in the United States: Regulation of Crops and Their Food Products

Abstract

In the United States, federal administrative agencies, including the US Department of Agriculture (USDA), implement statutes and regulations that govern genetically engineered plants and their products. US regulatory measures were developed in light of genetic modification using rDNA, before the advent of new technologies, including gene editing, that offer simple, elegant paths to genetic improvement in plants. After a brief review of global and US production of GE crops, this Chapter analyzes US policy and regulation of these crops and their food products, with emphasis on the role of USDA. The Chapter addresses significant issues raised by GE crops: coexistence of GE and non-GE crops, low-level presence, tort liability, and the new US labeling law for bioengineered foods. Recent policy statements encourage modernized science-based regulation, but some uncertainty applies to regulation of crops developed with new genetic technologies. The Chapter analyzes USDA’s governance of new crop varieties with a focus on the “Am I Regulated?” process, which determines whether new organisms are subject to USDA regulation. The USDA has declined regulatory jurisdiction for a number of products of gene editing and has indicated its intention not to regulate crops developed with certain new technologies. Finally, the Chapter outlines some regulatory challenges posed by advances in biotechnology.