New approach methods in chemicals safety decision-making – Are we on the brink of transformative policy-making and regulatory change?

Decision-making on the use and management of chemicals in society is on the brink of a scientific and technological revolution. At the same time world politics is focusing more on chemicals, waste and pollution prevention, alongside climate change and biodiversity loss. To enable effective decision-making, policy makers and regulators will need to draw upon the best scientific evidence available on the real-life causation and consequences of adverse effects of chemical and waste exposures affecting humans, wildlife and the environment. New Approach Method (NAM) data from modern day multidisciplinary science and technology is becoming more available using cheminformatics, computational prediction algorithms using AI, transcriptomics, genomics, proteomics, mathematical modelling, epidemiology, biological monitoring, and clinical science. Current chemical regulation has been shaped by the animal models of the 20th century. NAMs and Next Generation Risk Assessment (NGRA) have the potential to better support innovations in chemicals and materials through science-informed decision making that is more species-relevant and protective of adverse outcomes; this will require future-proofed regulatory transformation. Capacity building and skills development in computational and in vitro NAMs will be key to this transformation.