Transforming the Evaluation of Agrochemicals: A Conceptual Model

Abstract

Globally, regulatory authorities face the challenge of integrating advances in science and technology into existing frameworks for agrochemical risk assessment. Addressing this challenge is critical to meeting the demands of food safety and quality for a growing population. To support this shift, the Health and Environmental Sciences Institute (HESI) convened a multi-stakeholder committee of international scientists. Through a problem formulation-led strategy, the committee developed the Transforming the Evaluation of Agrochemicals (TEA) conceptual model to guide the adoption of new methods, best practices, and technologies into regulatory practice for agrochemical safety. The core of the model incorporates the well-established tiered approach routinely used for identifying and characterizing hazards and assessing exposures; however, the model strategically identifies three sequential elements: exposure-led, adaptability, and inclusion of new science. The central core is then surrounded by layers with additional elements, namely: fit-for-purpose over time, adapt to global need, adapt to local need, create incentives, data sharing and transparency, and build trust. Collectively, these ten elements and their intersections result in a novel, TEA conceptual model with elements that have not been simultaneously implemented in any regulatory data package to date. In providing guiding principles, two examples of regulatory applications, and a concise summary of how this model supports an opportunity to go beyond next generation risk assessments focused primarily on alternative approaches to animal testing, we demonstrate the utility of the TEA conceptual model as a tool and mechanism supporting a structured and systematic application towards the intended transformation of agrochemical evaluations.