Environmental risk assessment: Similarities and differences between crop protection chemistry and plant-incorporated protectants

Environmental risk assessments are conducted as part of the registration process for crop protection chemicals and plant-incorporated protectants. For both chemicals and seeds, several Tier 1 laboratory toxicity studies are conducted using non-target organisms to determine the intrinsic toxicity of a chemical or trait. Risk assessments are then conducted using the laboratory hazard data, and the expected environmental exposure information for the product for registration. Additional laboratory or field studies may be required to refine the risk assessment for registration. While both processes ultimately result in protection of non-target organisms in the environment, there are similarities as well as differences between the two processes. For example, the process for crop protection products is long-established, uses codified guidance for study conduct and risk assessment calculations, and has solid threshold of concern values driving decision making. While for plant-incorporated protectants, the studies conducted and risk assessment exposure calculations are more fluid as they develop further. Both are assessed in the United States by the Environmental Protection Agency (EPA), while the Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) have a coordinated framework with the EPA for registration decisions on each genetically-modified crop. We will present an overview of the risk assessment frameworks for crop protection products and genetically-modified seeds.