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So far, we have received comments on the proposed scientific quality criteria from the Federal Office of Consumer Protection and Food Safety, Germany (BVL) on October 5th, 2016. The comments can be downloaded here.

 

The G-TwYST research team responded to the BVL comments on November 28th, 2016. The response can be downloaded here.

 

 

Members from the GRACE and G-TwYST research teams recently published “Proposed criteria for the evaluation of the scientific quality of rat and mouse feeding trials with whole food/feed derived from genetically modified plants” in Archives of Toxicology. We cordially invite all stakeholders to contribute to further developing these criteria by sending comments.

 

As one of its tasks G-TwYST developed and proposes criteria to evaluate the scientific quality of 2-year feeding trials. These criteria are now being published in order to trigger a broader discussion in the scientific community an among GMO risk assessment stakeholders. These quality criteria have been developed based on the experience and standards in other toxicity assessment contexts.

 

The proposed quality criteria are:

  1. The design of the feeding trial is based on internationally recognized test guidelines, but adapted for specific needs of whole food/feed studies and non-targeted testing.
  2. An analysis of the plant materials and diets including, among others, macro- and micronutrients, biological and chemical contaminants as well as the identification and quantification of the event, is performed.
  3. The highest level of the plant material that can be incorporated in the animal diets without leading to a nutritional imbalance is tested.
  4. A non-GM line with a comparable genetic background is used as a control.
  5. Specific aspects regarding the choice and housing of the laboratory animals used in the feeding trials are considered.
  6. Appropriate randomization techniques are applied.
  7. A reliable and appropriate sample collection and processing strategy is implemented.
  8. The staff performing the feeding trial and the analysis of the plant materials, diets and animal samples is “blind” with respect to the identity of the diets.
  9. Appropriate statistical methods are applied to evaluate the power of the study and to analyse the obtained results.

 

 

Comments to this and other recently published GRACE papers (http://link.springer.com/article/10.1007/s00204-016-1798-4, http://link.springer.com/article/10.1007/s00204-014-1374-8) can be sent either:

  • to for publication on the GRACE/G-TwYST website. These comments will be put without further peer-review or editorial polishing on our websites. Depending on the nature of the comment, The GRACE and G-TwYST teams will opt for a response at the project website, if deemed necessary. Offending or discrediting comments will not be accepted for publication,
  • directly to Archives of Toxicology. These comments will be answered by the respective project team in form of a Letter to the Editor, if deemed necessary and according to the publication policy of the journal.

 

Schmidt, K., Döhring, J., Kohl, C. et al. Arch Toxicol (2016) 90: 2287. doi:10.1007/s00204-016-1762-3, http://link.springer.com/article/10.1007/s00204-016-1762-3

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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.