About 60 participants attended a workshop on the updated EFSA guidance on the benchmark dose (BMD) approach, which took place in Brussels on 1-2 March 2017.
Participants included representatives from food safety authorities across the EU, the European Medicines Agency, the European Chemicals Agency, the European Commission, the US Environment Protection Agency, the US Food and Drug Administration, Food Safety Australia New Zealand, the Food Safety Commission Japan and the World Health Organization.
More than 800 people from all over the world followed the workshop via a live video webstream. EFSA presented its updated guidance for using the BMD approach in risk assessment and a new EFSA web tool for performing BMD analysis. There were discussions comparing EFSA’s approach with those of the EPA in the United States and the WHO.
Broad consensus reached
Experts reached a broad consensus on the principles behind the dose-response modelling and benchmark dose analysis. In particular they agreed that:
- The BMD approach is superior to the No Observed Adverse Effect Level approach.
- “Model averaging” should be used instead of “single model” analysis where possible because the former approach accounts for model uncertainty.
- A wide variety of tools are available for performing BMD analysis, among which is a new web-based platform developed by EFSA and the Dutch National Institute for Public Health and the Environment (RIVM).
- Assessors should consider all toxicological information before embarking on modelling and interpret the modelling outcome in the light of the understanding of the toxicology.
- BMD modelling should be reported in a transparent manner.
- Training is needed to further disseminate the use of this methodology.
- There is a need for an international platform to share views on how to perform BMD analysis; such a platform should be opened to the broad modelling community, including microbiologists, to make the best use of existing expertise in dose-response modelling.
The workshop was also an opportunity to discuss a number of issues where further agreement is still needed. These included using constraints on the model parameters to prevent “infinite” slopes at dose zero, and also the need to modify existing test guidelines so that more dose groups are considered (but using the same total number of experimental animals), enhancing dose-response information in the datasets produced.
EFSA’s Scientific Committee is setting up a standing working group on BMD analysis in the coming months. The group will include statisticians, toxicologists and risk assessors who will assist EFSA’s experts in applying the guidance.
- General considerations
- Part 1: Guidance to apply the BMD approach
- Part 2: Fitting Models & Goodness of Fit
- Part 2: Dichotomous Model Averaging
- Part 3: BMD flow chart, Establishing the BMD confidence interval
- Manual for BMD Modeling
- U.S. EPA Benchmark Dose - Modeling Guidance
- Other Approaches for BMD - Analysis - The WHO Approach