GRACE published its final conclusions and recommendations
The conclusions and recommendations of the GRACE project have been discussed with stakeholders in October 2015 in Vienna and at the final conference in November 2015 in Potsdam. The final version is now available.
Part I of this document covers conclusions and recommendations on animal feeding studies and alternative approaches. The task of GRACE was to test the design, execution and interpretation of rodent feeding trials (90-day and extended studies) and alternative studies with whole food/feed in order to provide recommendations on the appropriateness of these tools for the risk assessment of GM crops by considering the scientific strengths and limitations of the different approaches. The outcomes will be reviewed by the Commission by mid 2016 in order to reappraise the requirement to mandatorily perform a 90-day feeding trial with whole GM food/feed as demanded by the Implementing Regulation (EU) No. 503/2013.
MON810 maize was chosen as a test material as several MON810 and near-isogenic varieties could be cultivated in Europe and several data sets from feeding trials with MON810 exist. It has to be underlined that GRACE is not expected to provide data for the reassessment of the safety profile of MON810 maize, but to explore the value of the different approaches for the risk assessment of whole GM food/feed.
One significant result is that GRACE data did not provide any indication that the performance of 90-day feeding studies (following OECD or EFSA guidelines and current practice) with whole food/feed would provide additional information on the safety of maize MON810 when compared to the compositional comparison of the GM line and its closest conventional comparator in terms of an initial comparative safety assessment.
Part II lays down conclusions and recommendations on the use of systematic reviews and evidence maps when summarizing and evaluating GMO impact data. The GRACE project aimed to increase the transparency and traceability of information about the potential risks and benefits associated with the deliberate release of GM crops.
Two evidence synthesis concepts, namely systematic reviews and evidence maps, were applied to identify, analyse and communicate primary research data on potential impacts of GM crops and their products on human and animal health, the environment and socio-economic indicators in a transparent, reproducible and unbiased manner.
Systematic reviews are evidence synthesis approaches which have become well established in medical science to inform evidence-based decision making. Their use is expanding to other disciplines to inform regulatory decision making, including food/feed safety assessment. Systematic reviews are based on a standardized and rigorous methodology to improve precision, minimize bias, and increase transparency – prerequisites for a robust synthesis of existing evidence.
GRACE demonstrated that systematic reviews and evidence maps may provide added value when informing different risk assessment or risk management steps about GMO impacts. Reviews conducted in the course of the project confirmed, for example, the conclusions of previous risk assessments of Bt and HT crops with regard to field impacts on the evaluated groups of organisms.
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