- February 10, 2022
About the Speaker
Andrew N. Miglino, Ph.D.
Environmental Team 2
Division of Scientific Support (DSS)
Office of New Animal Drug Evaluation (ONADE)
Center for Veterinary Medicine (CVM)
U.S. Food and Drug Administration (FDA)
Dr. Andrew Miglino is a physical scientist on the FDA Center for Veterinary Medicine’s Environmental Team. Dr. Miglino has conducted environmental reviews of difficult to test substances, steroid hormones, and aquaculture drugs among other veterinary medical products, and is the primary developer of a computer model that estimates concentrations of animal drugs in the soil and water environment, known as VETPEC. Dr. Miglino received his Ph.D. in Environmental Engineering from the University of Delaware and specializes in environmental fate modeling.
About the Presentation
As part of the environmental review process under the National Environmental Policy Act (NEPA), the Center for Veterinary Medicine (CVM) determines the exposure concentration for proposed new animal drugs in the environment. Due to the complexity of estimating these concentrations for the various environmental conditions in the United States, CVM has developed an environmental fate model, VETPEC, which uses animal characteristics, spatially and temporally variable data, and modern scientific principles to calculate daily environmental concentrations of animal drugs. This seminar will highlight CVM's environmental review process with a focus on the exposure assessment.
After completion of this activity, the participant will be able to:
- Identify the methods CVM uses to evaluate the potential for environmental impacts.
- Describe the challenges of estimating concentrations of animal drugs in the varying United States environments.
- Examine the tools developed to estimate environmental concentrations of new animal drugs.
|Activity Outline FDA Grand Rounds: February 10, 2022
|pdf (1.85 MB)