EPA and EFSA Benchmark Dose Guidance
Benchmark dose (BMD) modeling has become the preferred approach in the analysis of toxicological dose-response data for the purpose of deriving human health toxicity values. The software packages most often used are Benchmark Dose Software (BMDS, developed by EPA) and PROAST (developed by RIVM). In many ways, both packages are similar, and the resulting BMD confidence intervals are very similar when the same settings are used. However, there are a few differences in the practice of BMD modeling between the United States and European Agencies Additionally, different organizations have released their own technical guidance documents. This presentation will briefly present the U.S. Environmental Protection Agency’s (EPA) and the European Food Safety Authority’s (EFSA) technical guidance for modeling dichotomous and continuous dose-response data. Topics covered will include the models used, model selection criteria applied, the benchmark response levels considered, and alternative modeling approaches (e.g., model averaging). Most importantly, both the differences and similarities of the two guidance frameworks will be covered, with a particular focus on the continued efforts by both agencies for the harmonization of methods.
Disclaimer: The views expressed in this abstract are those of the authors and do not necessarily represent the views or policies of the U.S. Environmental Protection Agency.