TY - JOUR
KW - Barriers
KW - Chemical regulation
KW - Drivers
KW - new approach methodologies
KW - Next generation risk assessment
KW - Perspectives
KW - Social science
KW - survey
AU - Angela Bearth
AU - Nicolas Roth
AU - Tom Jansen
AU - Laura Holden
AU - Aleksandra Čavoški
AU - Emma Di Consiglio
AU - Ingrid Hauzenberger
AU - Robert Lee
AU - Enrico Mombelli
AU - Olga Tcheremenskaia
AU - Lina Wendt-Rasch
AU - Martin F. Wilks
AB - The traditional approaches to chemical risk assessment for human health are continuously challenged by their limitations, such as validity concerns, societal pressure to use animal-free methods, and resource constraints. New Approach Methodologies (NAMs) are considered a promising avenue toward modernisation of chemical risk assessment practices but their implementation in practice has been slow. This article aims to investigate the perspectives of human health risk assessors on the status quo, barriers and drivers of the acceptance and use of NAMs across different regulatory frameworks. A mixed method design was applied: qualitative interviews (N = 19) and an online survey with human health risk assessors from industry, regulatory agencies/institutions and academia (N = 222). The results show heterogeneity in familiarity and use of specific NAMs (e.g., QSARs as well-known and used vs. −omics approaches that are seldom used), the risk assessors’ background (e.g., industry vs. regulatory agencies and institutions vs. academia) and the application context (e.g., screening/prioritisation vs. hazard identification/characterisation). The identified barriers and drivers offer pointers for the future integration and acceptance of NAMs in regulatory risk assessment. For instance, guidance documents can facilitate the use of NAMs, showcasing successful examples that increase trust in the methods and thus, the risk assessors’ confidence in using these methods. Among other things, the article highlights the importance of considering human health risk assessors’ needs and prerequisites to foster bottom-up coordinated efforts and to ensure the success of top-down legal and institutional change to incorporate NAMs in regulatory risk assessment.
BT - Environment International
DA - 2025-02-01
DO - 10.1016/j.envint.2025.109279
N2 - The traditional approaches to chemical risk assessment for human health are continuously challenged by their limitations, such as validity concerns, societal pressure to use animal-free methods, and resource constraints. New Approach Methodologies (NAMs) are considered a promising avenue toward modernisation of chemical risk assessment practices but their implementation in practice has been slow. This article aims to investigate the perspectives of human health risk assessors on the status quo, barriers and drivers of the acceptance and use of NAMs across different regulatory frameworks. A mixed method design was applied: qualitative interviews (N = 19) and an online survey with human health risk assessors from industry, regulatory agencies/institutions and academia (N = 222). The results show heterogeneity in familiarity and use of specific NAMs (e.g., QSARs as well-known and used vs. −omics approaches that are seldom used), the risk assessors’ background (e.g., industry vs. regulatory agencies and institutions vs. academia) and the application context (e.g., screening/prioritisation vs. hazard identification/characterisation). The identified barriers and drivers offer pointers for the future integration and acceptance of NAMs in regulatory risk assessment. For instance, guidance documents can facilitate the use of NAMs, showcasing successful examples that increase trust in the methods and thus, the risk assessors’ confidence in using these methods. Among other things, the article highlights the importance of considering human health risk assessors’ needs and prerequisites to foster bottom-up coordinated efforts and to ensure the success of top-down legal and institutional change to incorporate NAMs in regulatory risk assessment.
PY - 2025
EP - 109279
ST - New approach methodologies in human health risk assessment across European regulatory frameworks
T2 - Environment International
TI - New approach methodologies in human health risk assessment across European regulatory frameworks: Status quo, barriers and drivers for regulatory acceptance and use
UR - https://www.sciencedirect.com/science/article/pii/S0160412025000303
VL - 196
Y2 - 2025-10-07
SN - 0160-4120
ER -