Introduction to the U.S. Regulatory Regime for GMOs

Presently, it is questionable whether the genetically engineered foods are adequately controlled and/or regulated under U.S. law. There is no single federal statute or federal agency that governs the subject matter.[1] Three federal agencies are primarily responsible for the regulation of genetically engineered foods[2] – the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA). Each federal agency is assigned certain regulatory responsibilities. FDA provides voluntary pre-market consultations with food companies, seed companies, and plant developers to ensure that biotechnology derived foods meet regulatory standards for safety. USDA’s Animal and Plant Health Inspection Service (APHIS) licenses field testing of crops prior to commercial release of newly developed plant strains. EPA registers pesticides in U.S. commerce (including plants engineered to produce pesticides) and establishes levels at which pesticides in foods are permitted. The White House outlined this multi-agency approach to regulating the products of biotechnology in a 1986 document entitled Coordinated Framework for Regulation of Biotechnology.

There are many critics of the U.S. regulatory regime. For example, many say that the U.S. regulatory regime only confronts a few aspects of the issue, and then only in a piecemeal, haphazard fashion.[3] In the next couple of posts, I will explore each agency’s role in the regulation and control of genetically modified foods.

[1] See John Charles Kunich, Mother Frankenstein, Doctor Nature, and the Environmental Law of Genetic Engineering, 74 S. Cal. L. Rev. 807, 823 (2001).

[2] Donna U. Vogt and Mickey Parish, Food Biotechnology in the United States: Science, Regulation, and Issues, (United Stated Dept of State), available at (last visited on August 1, 2009).

[3] Kunich, supra note 1, at 823.