Risk assessment decision-making transparency

Assessors should base their selection of methods on clearly defined decision criteria, and they need to communicate the results using clear and transparent language. This includes statements on the extrapolation issues that were considered but not addressed, and the magnitude and direction of the bias that may have been introduced by the extrapolation or lack thereof. In lower tiers and prospective risk assessment, this should lead to setting more appropriate UFs and ensure that lower tier approaches are more conservative than higher tier approaches. All this helps assessors to make informed decisions, on one hand, but it also allows the identification of future research needs, on the other hand, especially when methods are not available. 

Uncertainties in risk assessment include considerations related to missing, incomplete and/or incorrect knowledge, as well as those associated with ignorance and/or lack of awareness. Uncertainties should be characterized as transparently as possible to ensure their adequate consideration in decision-making concerning the need for and nature of appropriate risk management and communication. 

Through the review of approaches to explicit qualitative consideration of contributing sources, this section offers a framework to facilitate and promote a qualitative consideration of the impact of uncertainties on exposure assessment where data are very limited and/or as a prelude to more quantitative characterization of uncertainties. Transparency to address uncertainties and specification of those uncertainties that impact most on outcome are essential to effective decision-making in risk management. 

Clearly, uncertainty can be an issue if the limitations of the inputs are not fully transparent or understood in the decision-making process. Therefore, as part of any risk assessment ... 

Lacking explicit regulatory provisions or a transparent decision-making process under TSCA, one can still infer something about the US EPA s assessment of the risk from exposure to a new chemical substance by triangulating from the three published benchmarks described below. 

Transparency is an important hallmark of data quality, one that should be represented in every phase of an exposure assessment. Access to key information is necessary not just for the exposure assessor making some initial decision about how to use particular data, but also for the risk assessor or decision-maker faced with evaluating those choices and their implications. 

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