The use of NAMs and omics data in risk assessment

Abstract

The animal-centric approach so far predominantly employed in risk assessment has been questioned in recent years due to a number of shortcomings regarding performance, consistency, transferability of results, sustainability, costs and ethical reasons. Alternatives to animal testing, collectively termed NAMs, may have the potential to deliver sound, cost-effective, prompt and reliable information, but their regulatory acceptance has not been established yet. The main reasons behind this are mostly related to actual methodological obstacles, with particular reference to addressing complex endpoints such as repeated-dose toxicity, the issue of translating the concept of adversity to NAMs, and doubts of stakeholders about the level of chemical safety ensured by NAMs. With the aim of providing an updated view on major conceptual and methodological developments in the field of toxicology, a symposium and a workshop were organised by the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) and Helmholtz Centre for Environmental Research on 15–17 November 2021 in Berlin. The conference, entitled ‘Challenges in Public Health Protection in the 21st Century: New Methods, Omics and Novel Concepts in Toxicology’ brought together eminent scientists with representatives from industry and regulatory authorities. The organisation, day-to-day operations and the reporting of the event main outcomes in a position paper were the main focus of the present EFSA EU-FORA work programme. Tasks pertaining to ‘The use of NAMs and omics data in risk assessment’ were implemented under the shared supervision of units ‘Testing and Assessment Strategies Pesticides’ and ‘Effect-based Analytics and Toxicogenomics’ of the German Federal Institute for Risk Assessment.