Applying problem formulation and plant pest risk assessment during USDA's regulatory status review of insect resistant genetically modified plants

According to the USDA's updated biotechnology regulations, developers can ask for a regulatory status review (RSR) of a genetically engineered plant to determine if it falls under the rules described in 7 CFR § 340.4. This talk will discuss how the USDA's problem formulation and plant pest risk assessment is applied to plants that have been modified to produce pesticidal products for insect resistance. It will focus on examples of RSR requests that have cleared the initial review process without proceeding to Step 2 and those that have not. In Step 2, the USDA considers whether the modified traits affect beneficial organisms (non-target organisms) in the agroecosystem as part of its plant pest risk assessment.