All Times EDT
Keywords: environmental fate, animal drugs, farm, environmental concentration
The United States (US) Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) conducts prospective environmental risk assessments to evaluate the potential for significant environmental impacts to occur from the approval of new animal drugs. In this presentation, the Veterinary Environmental Transport and Fate Models for Predicting Environmental Concentrations (VETPEC) environmental fate model will be shown. This model was developed by CVM, in collaboration with the US Environmental Protection Agency (EPA). VETPEC calculates predicted environmental concentration (PEC) values for animal drugs in manure (PECmanure), soil (PECsoil), and water (PECwater), provides a singular framework that offers the potential to address the regulatory needs described in US FDA/CVM Guidance for Industry 89 and 166 (Phase I and Phase II Environmental Assessments, respectively), and has the potential to enable CVM and drug sponsors to easily and consistently estimate exposure concentrations for use in exposure and risk assessments. The VETPEC suite accounts for differences in soil, weather, and industry practices, by leveraging EPA crop scenarios for model farms throughout the US to predict daily and summary PEC values for a 50-year simulation.
Interpretation of data resulting from simulations using the VETPEC suite is key to properly evaluating the potential risk. Over each 50-year simulation, approximately 18,000 daily PECsoil and PECwater values are generated for each scenario simulated. These results are summarized based on a statistical framework to allow CVM to evaluate the significance of impacts from the drug to the environment. Appropriate selection of the method used to summarize these data is critical to evaluating the risk.
This presentation will discuss the data needs that were instrumental to the development of the VETPEC suite, the environmental pathways evaluated, and the interpretation of the data generated from the simulations.