Risk assessment should be the basic operating principle for regulatory decision-making. An exposure-driven assessment for chemicals proposes a paradigm shift in support of global, harmonized, risk assessment-based regulatory decision-making. Application of best available science creates tailored exposure-driven risk assessments. The Health and Environmental Sciences Institute (HESI) Risk Assessment in the 21st Century (RISK21; www.RISK21.org) project is a scientific, transparent, and efficient approach to inform human health risk assessment. This systematic approach evaluates and integrates mechanism-based knowledge with exposure consideration allows for hazard characterization that is scientifically defensible and appropriate for regulatory decision-making of crop protection products. Using the RISK21 problem formulation based and exposure driven evaluation strategy enables public health protective decisions to be made without unnecessary use of animals in large scale and redundant studies. Using the knowledge accumulated from the intended use and class of chemistry of the proposed pesticide will focus the questions that need to be answered to protect human populations from cancer risk. Investigation of the metabolic profile and basic hazard knowledge such as genetic toxicity, hormonal activity, immune suppression, target organ toxicity, and cell proliferation measures are sufficient to screen for the known drivers of human cancer. A weight of evidence approach using kinetic, in vitro, and short-term in vivo studies can inform a health protective chronic risk assessment of crop protection products without the need for a cancer bioassay. This transparent, systematic approach enables an improved process to efficiently achieve innovative solutions for crop protection with confidence in protecting public health.

Application of an integrated approach for chemical evaluation of human cancer risk

2019 Fall National Meeting

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