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The experimental test groups chosen and the minimum number of animals per group to be used are shown in the following table:

Group

% of daily dietary intake (w/w)

No. of animals

Isogenic non-
GM (NK603)

NK603

NK603 +
Roundup

Males

Females

1

33

0

0

16

16

2

22

11

0

16

16

3

0

33

0

16

16

4

22

0

11

16

16

5

0

0

33

16

16

Total

 

80

80

 

The number of animals per group has been chosen based on the OECD Test Guideline 408 and as recommended by the EFSA Guidance (2011).

 

A statistical analysis will be performed prior to the beginning of the feeding trial to determine whether the number of animals per group chosen is adequate, and, if necessary, it will be adjusted. The data to be obtained will be compared with background data on variations in endpoint values for Wistar Han Rcc rats fed a standard lab chow from Harlan Inc. present in the public domain (http://webapps.harlan.com/wistarhannover).

 

A statistical analysis of the data obtained will be performed by WP4 by taking into account, among other documents, the EFSA Guidance (2011) and will be accompanied by an analysis report. A specific chapter on assumptions and uncertainties will be included in the study report.

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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.