Conceptual Framework for a Modern Approach to assess Human Health and Ecological Risk from Agrochemicals using Read-across to Reduce Vertebrate Testing

Assessing the potential risk from exposure to agrochemicals, including non-food use pesticides, is a global regulatory requirement. By using an exposure-first approach to risk assessment, where the potential for exposure is determined before the potential for hazard, the toxicological data developed will be fit for purpose and address the exposures from the intended use and applications of the agrochemical. The conceptual framework is intended for the predictive risk assessment of non-genotoxic agrochemicals and encourages reliance on existing toxicological data, with new toxicity data supplemented only as necessary to refine risk. The iterative process allows for flexibility and refinement using new approach methods to fill data gaps and improve confidence in the assessment. An example of this conceptual framework will be presented showing the integrated approach of several lines of evidence including the estimated exposures and read-across analysis. Overall, taking a read-across approach to supporting the human health and environmental risk assessment for the target chemical can reduce the use of vertebrate testing, while maintaining protection levels for agrochemical safety evaluation. This example will demonstrate how this conceptual framework can be used to refine chemical risk assessments by developing testing strategies that are fit for purpose. Beyond this example, the conceptual framework may be utilized to meet global regulatory needs for agrochemical registration and is applicable for assessing other types of chemistries such as industrial chemicals, metabolites, and degradates.