APHIS, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have regulatory authority over GE organisms. APHIS has the authority to regulate the introduction of certain GE organisms and products under the Plant Protection Act and 7 CFR § 340, but a person may petition APHIS to have a regulated article de-regulated by showing under § 340.6 that the regulated item is unlikely to present a greater plant pest risk than the unmodified organism. To achieve non-regulation status, APHIS must then determine that the GE organism is unlikely to pose a plant pest risk through thorough analysis. In addition, the EPA has the authority to regulate pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 7 U.S.C. 136. Through testing, the EPA determines if the pesticide will cause unreasonable adverse effects on humans, the environment, and non-target species. EPA also sets tolerances for residues of pesticides remaining on food and feed products. Lastly, the FDA regulates GE organisms under the Federal Food Drug and Cosmetic Act (FFDCA) 21 U.S.C. 301. FDA implements voluntary consultations to ensure that food safety issues are resolved before commercial distribution so developers are in compliance with Federal food safety laws prior to marketing.
Bayer petitioned APHIS that FG72 did not pose a plant pest risk in 2009. After considering several environmental, production, socioeconomic and human and animal health issues, as well as public comments, numerous alternatives and cumulative impacts, APHIS granted the non-regulated status to FG72. The FDA concluded in July of 2012 that FG72 is not materially different than comparative soybeans now grown, marketed, and consumed in the U.S. Isoxaflutole is still under review by the EPA, but tolerance of isoxaflutole residues has already been established by final rule in the Federal Register.
For more information about APHIS’s analysis, please visit its website on the Draft Environmental Analysis of FG72.
Written by Sarah L. Doyle - Research Assistant
The Agricultural Law Resource and Reference Center
August 26, 2013