How Do We Make Cogent Causal Arguments with Adverse Outcome Pathways for Regulatory Risk Assessment?
Wednesday, December 11, 2024
3:00 PM to 4:30 PM (US EST, UTC -5)
Hosted by: The SOT Risk Assessment, Biological Modeling, and Ethical, Legal, Forensics, and Societal Issues Specialty Sections
Registration required for this free webinar.
What’s the objective of regulatory risk assessment? To me, it’s making a science-based argument that a chemical, a material, or a product is safe for use under specific conditions. Knowing that something causes a hazard isn’t enough. We need to really understand when something is safe for the intended use. In other words, we need to suss out under what conditions an exposure does not cause adverse effects (i.e., identifying conditions that cause an adverse effect should not be the goal – we are about safety). That cause-effect relationship, and the argument we use to articulate that relationship is critical because this is what the courts will use to determine whether or not liability exists, or whether or not a regulatory agency acted justly based on the science, rather than being arbitrary and capricious. There’s a lot of talk right now about using Adverse Outcome Pathways (AOPs) to either help formulate these causal arguments or to serve as a scaffolding for a causal weight of evidence determination. Although many do believe AOPs are always causal by their very nature, where they are a chain of key events, from some starting event (the molecular initiating event), that ultimately lead to an adverse outcome, the fact that an AOP is a chain of events does not make it inherently causal. Rather, there must be more to it than that. In this talk, we’ll explore how to make AOPs into causal chains. We won’t be relying upon Sir Austin Bradford Hill’s Conjecture; it is insufficient by his own admission. Rather, we will explore the same concepts for determining causality that are used in philosophy and in courts. By framing truly causal AOPs on causal philosophy, informed by reliable science, where we eschew pseudoscience, we will not only raise the quality bar for AOPs, but we will also begin to move regulatory toxicology and risk assessment arguments into something that will withstand muster in court. If we make weak arguments before the court, our arguments will suffer in court. After all, our goal should be to make cogent causal arguments with AOPs for regulatory safety and risk determinations.
Speaker:
- Lyle D. Burgoon, PhD, President and CEO, Raptor Pharm & Tox, Ltd.
Registration required for this free webinar.