Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop

HESI Global’s GTTC Nitrosamines Research Program is pleased to share a new publication in Mutagenesis: “Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop.”

The paper summarizes outcomes from a 2024 workshop co-organized by US FDA and HESI Global to optimize Ames test conditions for the evaluation of nitrosamines.

Key highlights:
• Ames test data generated by HESI GTTC, US FDA/NCTR, and EMA’s Mutamind were reviewed
• Recommendations and consensus points on key conditions that influence sensitivity, including metabolic activation, bacterial strains, solvents, and positive controls
• Results from all three research efforts confirm that Ames test conditions are more sensitive for detecting nitrosamines than the standard Ames test protocol
• Identified areas for continued research to support more harmonized, fit-for-purpose safety assessment approaches

Read the full publication here: Atrakchi et al., 2026. Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop. Mutagenesis.  https://doi.org/10.1093/mutage/geag011

Learn more about the Nitrosamines Research Program here: https://hesiglobal.org/gttc-nitrosamines/