Petitions

Developers may file a petition for the determination of nonregulated status to demonstrate their modified plant is not a plant pest and should no longer be regulated by USDA. Depending on the product, reviews by FDA and EPA may also be required. 

In the petition process, BRS evaluates interactions between the modified plant and plant pests, potential effects on non-target organisms, changes to weediness, and effects on other organisms which may acquire the modification from the modified plant. BRS also analyzes potential environmental effects following to the National Environmental Policy Act. 

When BRS reaches the conclusion that a modified plant presents no greater risk than the non-modified version of the plant, BRS designates it as nonregulated. Although developers often seek nonregulated status to produce a modified product commercially, a designation of nonregulated status does not necessarily mean it is produced commercially, and APHIS does not track a product’s commercial status after it is granted nonregulated status.