SOT FDA Colloquium: Integrated Approaches to Testing and Assessment: The Future of Regulatory Toxicology Assessment

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees.

On May 28, 2020 SOT and US FDA hosted a colloquium that featured an emerging flexible approach to evaluating and generating information to meet different regulatory purposes by means of Integrated Approaches to Testing and Assessment (IATA). This session introduced the concept, process, and components that comprise an IATA and present several case studies demonstrating different applications of this decision tool. Issues, challenges, and prospects of adopting IATAs in regulatory risk assessment were discussed.

IATAs are pragmatic, science-based frameworks for chemical hazard or risk characterization, which follow an iterative, integrative approach to answer a defined question with the required certainty in a specific regulatory context. Development of an IATA begins with problem formulation: the context of the decision and taking into account the overall risk management goals. Different types of information from existing sources, new testing (e.g., in chemico, in vitro, and in vivo), and non-testing (e.g., in silico), can be considered as needed, potentially using Integrated or Sequential Testing Strategies (ITS/STS) and evaluated using Weight of Evidence in an iterative process. IATA can be supported by Adverse Outcome Pathways (AOPs) that can inform hypothesis generation, weight of evidence analysis, and choice of assays for integrated assessment.