European risk assessor perspective on the quality of in vivo bioassays

As described in Regulation (EC) No. 1829/2003 on genetically modified food and feed, in the European Union (EU) the evaluation of risk/safety assessment of applications for cultivation of GM plants is carried out by a member state of the EU on mandate of the European Food Safety Authority (EFSA). Since the Regulation has come into force, Belgium has been involved in the evaluation of several cultivation dossiers on insect-resistant GM crops expressing cry genes derived from Bacillus thuringiensis. The lion’s share of the evaluations lay within the appraisal of the in vivo laboratory studies provided to assess potential impacts on non-target invertebrates. In particular, questions on the design of the laboratory studies and the interpretation of the data were raised. We will present an overview of the scientific questions raised in order to be able to include the laboratory studies as confirmatory evidence in the risk/safety assessment of impacts on non-target invertebrates from the exposure to insect-resistant GM crops.