Advancing Human health Risk Assessment: The Role of New Approach Methodology

DEEPIKA DEEPIKA¹Kanchan Bharti¹Shubh Sharma¹Saurav Kumar^1,2Rajesh Kumar Pathak¹Judit Biosca Brull³Oscar Sabuz³Silvia García Vilana⁴Vikas Kumar^1,2*

• ¹Pere Virgili Health Research Institute (IISPV), Tarragona, Spain
• ²German Federal Institute for Risk Assessment (BfR), Berlin, Germany
• ³Universitat Rovira i Virgili, Center of Environmental, Food and Toxicological Technology (TECNATOX),, Tarragona, Spain
• ⁴Escola Politècnica d’Enginyeria de Vilanova i la Geltrú (EPSEVG-GiES), Universitat Politècnica de Catalunya, Víctor Balaguer, 1, 08800, Vilanova i la Geltrú, Spain

New Approach Methodologies (NAMs) hold great potential to fill data gaps for chemicals and 2 modernisation of chemical risk assessment practices. Current toxicity testing is based on 3 conventional approaches with high reliability on in-vivo studies, but with time, regulators are 4 trying to move towards in-vitro and in-silico tools enabling efficient risk assessment 5 strategies. Herein, we discuss about different emerging techniques which are or can become 6 a NAM including both in-vitro and in-silico models with particular focus on reducing animal 7 studies and improving decision-making for hazard and exposure assessment. We also 8 discussed about the way to strengthen the regulatory and public confidence in different 9 NAMs and automation of these approaches. Some of these NAMs can help in identifying 10 biochemical mechanisms for toxicity, calculate the point of departure (PoD), develop 11 adverse outcome pathways (AOP), translate risk to multiple species and quantify 12 uncertainty from predictions for multiple chemicals. Scientists and regulators can work 13 together to frame robust guidelines for the practical application of these tools and ensure 14 reproducible results.