Considerations for reduced animal testing for environmental risk assessments of pharmaceuticals

SETAC NA 2023 -- Environmental risk assessments (ERAs) for chemical, crop protection products and pharmaceuticals are necessary to fulfil global registration requirements. The data needed to describe environmental fate and aquatic or terrestrial hazards can lead to large testing programs and potentially high vertebrate usage. In consideration of the global goal of 3R (replacement, reduction, refinement) testing approaches, we have been working on strategies to provide the data required to fulfil the needs of an ERA while minimizing animal use. We demonstrate these strategies through a series of case studies that industry partners and regulators can explore to reduce the use of vertebrates and expedite their ERA submissions.