Challenges and Opportunities in the Global Regulation of Crop Protection Products

Crop protection active ingredients and formulated products are essential tools for modern agriculture that serve to prevent yield loss related to insect, weed, or fungal pest pressure. Prior to commercialization, crop protection products must be authorized or registered across various regulatory jurisdictions globally. Registration decisions are based on the results of comprehensive testing requirements across multiple scientific disciplines. Full characterization of physical/chemical properties must be conducted, and specifications must be put in place for active ingredient purity and impurity levels. Additionally, studies to assess fate, behavior, and transformation in relevant environmental matrices are conducted. Hazard properties are identified by conducting multiple toxicology studies utilizing in vitro test systems as well as relevant invertebrate and vertebrate species. Hazard end points derived from these studies are then assessed relative to the exposure potential of the chemical obtained through empirical measurements or use of well-validated models. Taken together, the hazard and exposure profiles are used ultimately to assess risk to nontarget organisms as well as humans. If necessary, exposure assessments can be refined in several ways, for example, by conducting more comprehensive OECD test guideline studies to provide more refined end points, using sophisticated modeling approaches (e.g., probabilistic models), and implementing mitigation measures to reduce the potential for exposure. Looking forward, new crop protection technologies, including purified stereoisomer products, provide the opportunity to increase specificity against target pests and reduce potential off-target interactions. The rigorous process in place for assessment and registration of crop protection products provides a strong basis to ensure that under appropriate use conditions the benefits of the product can be realized without unacceptable risk to the environment or human health.