Since publication of the 2007 NAS report on “Toxicity Testing in the 21st Century: A Vision and a Strategy”, there have been significant multi-sector efforts to develop models and platforms aligned to turning this vision into a reality. What once seemed like an apparent mirage grows closer to reality as the research community explores combination in silico and in vitro approaches to advance our toxicity testing methodologies. As efforts have been underway to develop tools for prioritization of chemicals or in vitro acute alternative approaches as part of regulatory toxicology assessments, parallel efforts within industry have been underway to design predictive toxicology platforms to develop products of the future with more favorable environmental and human health profiles. Layered on top of these challenges is the global regulatory landscape, which is rapidly evolving, often in divergent ways, and can lead to throwing out the proverbial 'baby with the bathwater'. In this talk, we will provide case studies of the challenges that can arise when developing de novo approaches to novel molecule design, including interdependencies that must be balanced between key molecule characteristics. Discussion of validation of assays across chemistries with different physical chemical domains, main drivers for molecule selection, prioritization and weighting of end points, and case examples of various in silico and in vitro tools utilized within the crop protection product development field will be the focus on this presentation. Finally, a proposal will be presented on how to integrate various data streams into a semi-quantitative assessment scheme for the purposes of molecule design with an eye to providing science-driven decision making to global regulatory agencies and stakeholders.

Navigating the global regulatory landscape for crop protection products: Lessons learning and opportunities for the future

256th National Meeting (2018)

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