Towards achieving a modern science-based paradigm for agrochemical carcinogenicity assessment

The rodent cancer bioassay has been the standard approach to fulfill regulatory requirements for assessing human carcinogenic potential of agrochemicals, food additives, industrial chemicals, and pharmaceuticals. De-cades of research have described the limitations of the rodent cancer bioassay leading to international initiatives to seek alternatives and establish approaches that modernize carcinogenicity assessment. Biologically relevant approaches can provide mechanistic information and increased efficiency for evaluating hazard and risk of chemical carcinogenicity to humans. The application of human-relevant mechanistic understanding to support new approaches to carcinogenicity assessment will be invaluable for regulatory decision-making. The present work outlines the challenges and opportunities that authorities should consider as they come together to build a roadmap that leads to global acceptance and incorporation of fit-for-purpose, scientifically defensible new ap-proaches for human-relevant carcinogenicity assessment of agrochemicals.

Automated summary

The rodent cancer bioassay is the standard method for assessing the human carcinogenic potential of various chemicals. However, it has limitations, leading to international initiatives to find alternatives. Biologically relevant approaches can provide mechanistic information and improve efficiency in evaluating chemical carcinogenicity. This work outlines the challenges and opportunities in developing new, scientifically defensible approaches for human-relevant carcinogenicity assessment of agrochemicals.