Evaluation of animal feeding trials and alternative in vitro studies for the assessment of GMO impacts on human health
Work packages 1&2:
The safety of GM plants is subject to an intense political and societal debate, characterized by diverging positions in different EU Member States. There is, for example, an ongoing debate about whether 90-day animal feeding studies are needed to assess the safety of genetically modified (GM) plants.
Recently, a new EU Implementing Regulation came into force that makes 90-day feeding studies with whole food/feed mandatory in the safety assessment of GM plants and derived products. This move is the result of a long-lasting discussion between the Member States and the European Commission aiming to incorporate the European Food Safety Authority (EFSA) Guidance for the GMO risk assessment into a legal text.
Before the Implementing Regulation became effective, 90-day animal feeding studies have only been requested by the EFSA in indicated cases (see EFSA 2011 Food/Feed Guideline). Given the now mandatory nature of the 90-day study, the challenge is now to determine the scientific value and limitations of such studies and how they should be interpreted within toxicological risk assessment.
It is for this reason that the EU Commission has assigned the EU project GRACE with the examination of the validity of 90-day feeding trials (WP1) already before the adoption of the new Implementing Regulation and to compare the outcomes and performance with alternative in vitro methods (WP2).
In collaboration with international universities and research institutions, GRACE will design and conduct laboratory experiments to further refine the current test guidelines for 90-day feeding studies established by international organisations. GRACE will also evaluate and identify relevant in vitro approaches based on cell lines, and in silico methodologies that may be used as alternatives or complements to animal experiments.
Additionally, WP1 will also determine the added scientific value of 1-year animal feeding studies with whole food/feed compared to 90-day feeding studies in the risk assessment of GM food/feed.
The results of these studies will provide guidance for the use and improvement of existing methods for GM food and feed safety evaluations in the EU. The Implementing Regulation already determines a review of the requirement for a mandatory 90-day feeding study by end of 2015. The Commission will perform this review based on new scientific information such as the outcome of GRACE and other credible scientific knowledge.
GRACE involves stakeholders in research planning and drawing of conclusions. Read here for more information.
New Stakeholder Consultation Reports:
Consultation on Good Review Practice in GMO Impact Assessment
The database CADIMA (Central Access Database for Impact Assessment of Crop Genetic Improvement Technologies) will contain quality assessed studies and conclusions on the health effects, socio-economic consequences and environmental impacts of GM plants as well as raw data of animal feeding studies and alternative in vitro approaches.
It is currently under development and covers the projects GRACE and PreSto ERA-Net.