The Health and Environmental Sciences Institute (HESI) Risk Assessment in the 21<sup>st</sup> Century (RISK21) framework<b> </b>was developed via active collaboration of members of academia, government and industry. The aim was to establish a transparent, science-based, and efficient risk assessment framework, and the effort resulted in an integrated and systematic strategy for risk-based evaluation that is problem-formulation based and exposure driven. With this approach, an initial problem formulation phase guides the development of a conceptual model to articulate the needs of the assessment. Exposure and hazard information are acquired and evaluated in a tiered manner, allowing an informed decision to be made when sufficient evidence is available. Visual representation of hazard and exposure data on the RISK21 two-dimensional matrix allows for transparent communication of risk-based decisions, whether for screening and prioritization purposes or a definitive risk assessment. Ultimately, this methodology optimizes the use of resources by ensuring the risk assessment is fit-for-purpose. The approach can and has been used for multiple purposes such as chemical prioritization and screening, data gap identification, study design and communication. This presentation will provide an overview of the RISK21 framework and its potential applications.

RISK21: Overview of a transparent, exposure-driven, and fit-for-purpose risk assessment framework

2019 Fall National Meeting

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