Kerstin Schmidt
BioMath GmbH, Germany
Title: Proposed criteria for the evaluation of the scientific quality of mandatory rat and mouse feeding trials with whole food/feed derived from genetically modified plants
Biography
Biography: Kerstin Schmidt
Abstract
In recent years, animal feeding trials conducted with whole food/feed have been a focal issue in the controversy on the safety assessment of genetically modifi ed (GM) plants and derived food/feed. Within the scientifi c community and among stakeholders, quite diff erent views have been expressed on how these studies should be conducted, analysed and interpreted, what they might add in terms of information relevant to safety and whether 90-day rodent feeding trials should be mandatory. In the context of the ongoing debate on GMO risk assessment in Europe, it is crucial to investigate: Criteria for evaluating the scientific quality of subchronic, chronic toxicity and carcinogenicity studies with whole food/feed in rats and mice. This will
help risk assessors in evaluating this type of studies when provided in the course of a pre-market risk assessment and will create a basis for further general debate. Th is talk specifi cally addresses the question on how to evaluate whole GM food/feed feeding trials. It does so by proposing a list of key quality criteria for the evaluation of 90-day and extended feeding trials with whole food/feed derived from GM plants. Th e proposed quality criteria should be taken into account when evaluating a feeding trial in the frame of an application to regulatory bodies and are not intended to be applied in other cases in which a feeding trial is performed to answer a specifi c open question in basic research.