Workshop on EFSA’s updated Guidance on the use of the benchmark dose approach in risk assessment

In 2009, EFSA’s Scientific Committee developed guidance on the use of the benchmark dose (BMD) approach in EFSA’s risk assessments as an alternative to the traditional No-Observed-Adverse-Effect-Level (NOAEL) approach. EFSA updated the guidance in 2017 introducing model averaging to account for model uncertainty, including as well instructions on  how to apply the BMD approach in practice.

EFSA’s Scientific Committee decided to update the guidance again, following a workshop held in March 2017 to discuss commonalities and divergences in the various approaches for BMD analysis worldwide, and the update of Chapter 5 (dose-response assessment) of the WHO/IPCS environmental health criteria 240 that was released in 2020. The decision for this further update comes amid the need to align the Guidance document with internationally agreed concepts related to BMD, introducing Bayesian model averaging as well as a harmonised set of dose-response models for continuous and quantal responses.

In this context, EFSA held a workshop to disseminate the revised methodology for benchmark dose (BMD) analysis in EFSA’s updated Guidance document and to support its implementation in the R4EU BMD analysis platform.

The event took place on 15 and 16 February and was attended by around 80 on-site participants as well as 150 online participants for the plenary session.

The event was divided into two parts:

1. Presentation of the new guidance, changes to the previous version, and EFSA’s recommended approach for BMD analysis.
2. Illustration of the new approach, using the EFSA BMD analysis platform with pesticides-related case studies.

During the event, the in-person participants asked questions and interacted with the speakers. The participants provided very positive feedback about the workshop and acknowledged its usefulness. A recommendation was made to organise additional trainings for experts in and outside of Europe. EFSA informed participants about ongoing and upcoming follow up activities:

1. Creation of a BMR repository
2. Creation of a repositor of priors for different endpoints and test species
3. Development of guidance for BMD approach for epidemiological data.

Data for exercises Day 2

• Hatchling
• RatStudy
• Viable embryos

Instruction and solutions

Exercises & Solutions

Event recording

Contact

Do not hesitate to contact us at mese [at] efsa.europa.eu (mese[at]efsa[dot]europa[dot]eu) for more information.