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europa    seventh

 In the context of the ongoing debate on the risk assessment of GM food/feed in Europe, it is crucial to put the findings of the 2-year feeding study in a perspective that also covers not only normative dimensions.

 

Normative dimensions regarding whole-food animal toxicity studies for GMO risk assessment will be identified and characterised. In a second step an analysis on how they relate to the scientific aspects will follow. The overall approach is to compare the controversy on animal toxicity studies in GMO risk assessment to (i) other science-policy conflicts related to animal toxicity studies in food safety, which will be elaborated as case studies, e.g. radiated food (historical case study), aspartame (food additive), EHEC contamination (food contamination) and (ii) to routine toxicity assessment practice.

 

The draft analytical framework for the comparative analysis and the selection of case studies will be discussed and refined in a mini workshop with external experts. The draft analysis and conclusions will be summarised in a journal manuscript to be discussed and revised based on a combined expert/stakeholder workshop.


In the course of the above-mentioned expert/stakeholder workshop, the results from the analysis of normative dimensions will be brought together and the role of normative dimensions for the justification of long-term studies will be discussed.
 

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1-year feeding study with MON810 on ARTE

In October 2016 ARTE broadcasted "OGM - Mensonges et vérités" (GMOs - Lies and truths) on French and German Television. In this 100 minutes long documentary Frédéric Castaignède sheds light on genetically modified crops, the impact on farmers, biodiversity and human health. We have selected and translated a fragment in which G-TwYST project leader Prof Pablo Steinberg presents the results of the 1-year feeding study with MON810 maize in the GRACE project.

 

The documentary provides a ‘snapshot’ of the GRACE final Conference which took place on November 9-10 2015 in Potsdam, Germany. We refer to videos on the GRACE Youtube channel  for a full account.

 

Paper published describing the statistical approach for equivalence testing in G-TwYST

An open access paper describing the statistical approach for equivalence testing in G-TwYST has now been published in Food and Chemical Toxicology. The method was tested on data from the GRACE project, as described in this paper. We will now progress by applying the method in the statistical analyses of the G-TwYST feeding trials, to be reported first in the statistical reports as project deliverables.

Highlights

  • An equivalence testing method is proposed to assess the safety of regulated products
  • We combine data from a current study with test and control, and historical studies with assumedly safe reference products
  • The method is illustrated with animal feeding studies using genetically modified and reference maize varieties
  • A high statistical power of the equivalence test is the basis for the equivalence criterion
  • Generalized fiducial inference is used to integrate uncertainties from the historical and the current data

 

van der Voet H, Goedhart PW, Schmidt K (2017). Equivalence testing using existing reference data:  an example with genetically modified and conventional crops in animal feeding studies. Food and Chemical Toxicology, 109: 472-485. https://doi.org/10.1016/j.fct.2017.09.044

G-TwYST Interim Report available

15 February 2017

 

The G-TwSYT team completed a publicly available Interim report with information about the progress that has been made in the first 1.5 years of the project. The report can be downloaded here.