Chemical risk assessment, including in occupational health settings, is currently based primarily on animal models or human data. New Approach Methodologies (NAMs) are being developed as part of next-generation risk assessment, driven in part by their improved relevance to humans and considerations related to animal welfare. These methods are also expected to provide a more efficient way of assessing the health risks posed by chemicals.
This project will investigate whether, and for which health outcomes and regulatory areas, new methodologies are ready for implementation. Through occupational health-relevant case studies, the project will identify challenges and necessary improvements that can enhance the reliability and applicability of NAMs for chemical risk assessment.
STAMI is leading a case study that evaluates whether advanced lung cell models, namely air–liquid interface (ALI) models, are sufficiently applicable and reliable for assessing local lung irritation. This case study is relevant forthe derivation of occupational exposure limits for substances that cause respiratory irritation.
STAMI will also contribute to a case study assessing whether various cell-based NAMs for neurotoxicity can be used in the derivation of occupational exposure limits for neurotoxic substances.
A third case study focuses on the screening of CMR substances (carcinogenic, mutagenic, and reprotoxic substances). Occupational cancer is a complex health outcome, which makes the application of NAMs particularly challenging in the risk assessment of these substances. It is therefore important to investigate whether new methodologies can accurately predict whether a substance possesses CMR properties.
The project has considerable scientific potential and significance. The results may be used in regulatory risk assessment and are highly relevant to national occupational health authorities. By identifying challenges and necessary improvements, the project will support the further development of new approach methodologies for chemical risk assessment. This, in turn, will promote the increased use of such methods in the derivation of occupational exposure limits and other regulatory processes, ultimately benefiting workers’ health.
External partners: The project is part of a PARC-project which is led by RIVM (The Netherlands) and ISS (Italy), in cooperation with 14 other partners from Europe.
External financing sources: Horizon Europe (EU)
More informasjon about the research program: https://www.eu-parc.eu/
PARC-project number: RegulatoryNAMs (P6.4.2.d)
More information is to be found on the Norwegian project page