Lectures and seminars IMM Seminar: The use of New Approach Methodologies in regulatory toxicology and health risk assessment
George Kass, Professor, University of Galway, College of Medicine, Nursing and Health Sciences
In Europe, food safety with respect to chemical contaminants and chemicals intentionally added mostly rests on the assessment of data derived from in vivo animal toxicity data and using traditional endpoint measurements. Over the past decade substantial efforts have been made both at political level and through major research initiatives to move away from animal studies and to replace them with new types of studies that use in vitro, in silico and in chemico approaches. These are now collectively referred to as New Approach Methodologies or NAMs. NAM-based approaches should allow for a more precise risk assessment as they can be conducted on human-relevant cells and take advantage of contemporary knowledge of mechanisms of chemical-induced cell injury and of the pathology of human diseases. However, the uptake of NAMs in regulatory chemical risk assessment has so far been rather limited in Europe, even though risk assessment agencies such as EFSA have pledged that over the coming years, new data request should mainly be of NAM origin. The presentation will provide an overview of the challenges faced by regulators in the implementation of NAMs for regulatory decision making.
About George Kass
Georges Kass received his PhD in biochemical toxicology from Karolinska Institutet in 1990. After completing a post-doc at the Swiss Federal Institute of Technology in Zurich, he returned to the Karolinska Institutet as an Assistant Professor. In 1994, he moved to the University of Surrey in the UK where he became Professor of Toxicology. In 2009, he moved to the European Food Safety Authority in Parma, Italy, where he was Lead Expert in toxicology until his retirement in 2025. He was appointed Adjunct Professor at the University of Galway in Ireland in 2024. Professor Kass has published over 150 papers in the field of toxicology and chemical risk assessment. A substantial part of his research has focused on the molecular mechanisms of drug toxicity and on liver injury. He serves as the Associate Editor of Toxicology and Applied Pharmacology and the Chief Editor of Frontiers in Toxicology. In 2020, he was elected to the Académie d’Agriculture de France. He is also Honorary Member of EUROTOX and a Fellow of the US Academy of Toxicological Sciences (ATS).
Host: Anna Beronius, Institute of Environmental Medicine