2015 SOT FDA Colloquium: Contemporary Issues in Risk Assessment—June 17, 2015

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 June 17, 2015, SOT and US FDA co-hosted a colloquium focused on recent improvements in the practice of human health assessments. Exciting advances in the methods and best practices, consistent with the advice from the National Academies, have been made in the recent years and implemented by a number of stakeholders. Specifically, this session covered the lessons learned from (1) problem formulation and protocol development in chemical-specific human health assessments; (2) evidence identification and transparent criteria for inclusion and exclusion of the individual studies in the assessment; (3) harmonization of the cancer and non-cancer dose-response assessments; and (4) the use of the mechanistic data in support of human health assessments. Overall, the learning objective for this session was to demonstrate tangible examples of the implementation of the best practices in risk assessment to illustrate how the field is evolving to meet the needs of various stakeholders.

The National Academies of Sciences committee that produced a report “Science and Decisions: Advancing Risk Assessment” (NRC, 2009) recommended that “risk assessment should be viewed as a method for evaluating the relative merits of various options for managing risk rather than an end in itself.” How can the federal government best accomplish this goal?