Does the feeding of GM crop or derived products lead to alterations in health parameters indicative for a general toxicity or carcinogenicity as specified in OECD Test Guidelines 407, 408, 451, 452 and 453 in rats or mice? A systematic review protocol
Background: Rodent feeding trials are frequently applied to assess the safety of genetically modified plants. Even though their added value is controversially discussed within the scientific community, the Implementing Regulation (EU) No 503/2013 requests their mandatory conduct during the approval process of genetically modified plants for being placed on the European market. This systematic review aims at providing a comprehensive synthesis and critical appraisal of results from rodent feeding trials with whole genetically modified food/feed being performed to determine their potential to cause general signs of toxicity and/or carcinogenicity in the test animals. Methods: This study follows the systematic review approach to identify, select, appraise and synthesis data from included studies. The selection and critical appraisal process will be done by two reviewers independently from each other, whereas data will be extracted by one reviewer and rechecked by a second one. This review aims at providing a quantitative synthesis of results, whereas in any case a narrative synthesis will be provided. The review protocol was evaluated by external stakeholders with expertise in toxicology and systematic review methodology and their comments were considered during its finalization. In order to increase the efficiency of the review process, the online tool CADIMA will be used during the evidence synthesis process. Discussion: This systematic review aims at contributing to the controversial scientific debate being associated with the safety assessment of genetically modified plants and may support the clarification of potential uncertainties being accompanied with the conduct of rodent feeding trials, using whole genetically modified food/feed as test material.