Chronic Toxicity (1 year) Study on Rodents
The objective of this study is to determine the added scientific value of chronic toxicity studies with whole food/feed compared to 90-day feeding studies and comparative compositional analyses in the risk assessment of GM food/feed. The study design is based on the OECD Test Guideline 452 for Testing of Chemicals (chronic toxicity studies). Such chronic toxicity study shall provide information on the possible health hazards likely to arise from repeated exposure over a considerable part of the entire lifespan of the test animals. This study can provide information on the toxic effects of the test substance, indicate target organs and the possibility of accumulation.
In the proposed GRACE study (see also the draft study plan) the tested crop is Monsanto MON810 maize (variety DKC6667-YG). Controls are non-GM near-isogenic maize variety DKC666 and the conventional maize variety SY-NEPAL.
Based on the results, WP1 will draw conclusions and advise on
- the need for 1-year feeding trials (in comparison with 90-day feeding trials) for the assessment of GMO impacts on human health (by means of the ability of such animal feeding trials to detect changes in GM crops that may raise health concerns) and on
- the appropriate design of such studies on the basis of whole GM food or feed.
The related draft study plan has been subject of a written stakeholder consultation procedure (started on 6 Dec 2013, closed on 20 December 2014). The animal study will be conducted based on the revised plan. Once the results of these studies will be available, another stakeholder consultation will be organized in 2015 in order to discuss results and draft interpretations.
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