Two-day training  /  11/27/2019  -  11/29/2019

Training no. 4: Principles of genotoxicity in scientific assessment

Training topic

This training course will give guidance to participants on how to evaluate study data on genotoxicity and how to integrate corresponding testing results in risk assessment. Although genotoxicity testing of compounds used intentionally in food and feed or being natural and environmental contaminants has been routine for many years, the strategies/recommended testing batteries have changed and developed in points of detail in the course of time. 

The EFSA opinions of 2011 ("Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment") and of 2017 ("Clarification of some aspects related to genotoxicity assessment") will hold a central position in the training course, and their main issues will be elucidated and discussed in detail. After introductory lectures on biological backgrounds, participants will get an overview of the mechanisms of genotoxicity, relevant testing endpoints and systems, as well as the most important genotoxicity testing batteries and alternative in-vitro and in-vivo testing methods. Based on these, the strengths and weaknesses of single in-vitro and in-vivo test systems will be discussed and quality and reliability criteria for genotoxicity studies will be explained. The relevant genotoxicity testing guidelines [OECD, ICH S2(R1)] will also be illustrated and the basic principles of "Good Laboratory Practice" (GLP) will be introduced. The training course will furthermore be supplemented by an introduction to theoretical methods such as weight of evidence approaches and QSAR models.

This course module consists of four half-day sessions and will present a mixture of lectures, discussions and practical (hands-on) sessions. As an outcome of this training unit participants should be able to understand, handle and implement the different requirements on genotoxicity testing and the various recommendations given by EFSA for building up a step-wise testing strategy. Throughout the training, participants will be challenged to make links between what they have learned and their own work within EFSA.

 

Organizational details

EFSA staff is kindly asked to registered via the EFSA workflow, not via this website. EFSA reserves the right to select the participants of this two-day training course from all registered persons. Shortly after the registration deadline, all registrants will be informed whether they can actually attend the selected training.

Training materials will be sent to all participants a few days prior to the training.