White House announces planned revision of federal GMO regulatory standards.
- For decades, the United States government has regulated genetically modified organisms (GMOs) under a regulatory framework called the “Coordinated Framework for the Regulation of Biotechnology” (Coordinated Framework). The Coordinated Framework explains the different roles played by the three major agencies involved in the regulation of GMOs:
- The Food and Drug Administration (FDA) regulates GMOs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and ensures the safety and proper labeling of GMO-derived foods and feed.
- The Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) — a type of pesticide that is bioengineered into crops — under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and sets tolerance limits or exemptions from tolerance for pesticide residues on or in food and animal feed. EPA also regulates certain biological control organisms under the Toxic Control Substances Act (TSCA).
- The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) regulates GMOs under the Plant Pest Act. APHIS reviews GM crops to determine whether they meet the definition of a “plant pest” and may pose risks to domestic agriculture.
- The White House recently announced that FDA, EPA, and USDA will update the Coordinated Framework to reflect advances in science and technology that have occurred since the framework was last revised in 1992. In a memorandum to the heads of the responsible agencies, the White House indicated that the existing GMO regulatory framework has created “unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes….” The White House urged the Agencies to update and modernize their rules to continue to protect the public health while facilitating innovation in a transparent manner.
- GMO regulation continues to be a topic of heated discussion and legislative/regulatory activity among federal, state, and local regulatory officials, as well as stakeholders in the agricultural industry and the consumer safety sphere. The White House’s memo classifies the “development of an updated [Coordinated Framework]” as a “one-year objective,” although the actual implementation time frame remains to be seen. It will be interesting to see whether and how a potentially comprehensive (and long-overdue) update to the Coordinated Framework will influence national regulatory policy with respect to the safety and labeling of GMOs and GMO-derived food and feed products in the future.