The Path to UVCB Ecological Risk Assessment: Grappling with Substance Characterization

Abstract

Substances of unknown or variable composition, complex reaction products, and biological materials (UVCBs) pose a unique challenge to regulators and to product registrants, who are required to characterize their fate, exposure, hazard, and potential risks to human health and the environment. To address these challenges and ensure an efficient and fit-for-purpose process, it is proposed that the ecological risks of UVCBs be assessed following a tiered strategy. The development of this approach required exploring how substance composition ties into hazard and exposure information, and determining the extent to which a UVCB needs to be characterized to ensure a robust risk assessment. This article highlights the key aspects of this new method. It presents how a tiered substance characterization approach can be integrated into broader UVCB risk assessment schemes to encourage an examination of data needs before a full substance characterization is performed. The first tier of the characterization process, Tier 0, is a fundamental step that includes data from basic, lower resolution compositional analyses. Tier 0 assessments can be used to inform hazard and exposure for any substance of interest. The need for more sophisticated, higher tier characterization is determined by the level of uncertainty of the risk assessment. The next step of this work will integrate a tiered exposure assessment into the characterization scheme featured here, to create a more complete risk assessment framework.

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