GRACE- study: The EU-Commission needs to take action

15 December 2014 / Testbiotech has sent a letter to EU Commissioner Vytenis Andriukaitis re-stating its criticism of the Zeljenkova et al. (2014) publication on the outcome of a feeding trial with rats, conducted under the GRACE project funded by the EU Commission. The rats were fed over a period of 90 days with genetically engineered maize MON810, which produces an insecticidal protein, and the results were published in October 2014 in the journal Archives of Toxicology. Testbiotech is requesting that this publication be withdrawn for the following reasons:

• The conclusion of the study is not based on a sufficiently thorough assessment of the data that was obtained. In particular, it is unacceptable to dismiss the decrease of statistically significant, dose-dependent effects on total serum protein and relative pancreas weight, the latter accompanied by an increase in blood glucose levels, as toxicologically irrelevant. In terms of determining a dose with no toxic effects (no-observed-effect level) the study must be considered invalid.
• In addition to the concerns regarding the scientific content of the publication, Testbiotech found very serious problems with regard to conflicts of interest and the credibility of editors at the Archives of Toxicology.

The EU Commission was informed about these concerns more than a month ago, but has not responded so far. In the meantime, Testbiotech has received open letters from the coordinator of the GRACE project, Professer Joachim Schiemann and the editor-in-chief of Archives of Toxicology, Professor Jan G. Hengstler. They defended the publication and requested that Testbiotech send written comments to the journal.

However, Testbiotech does not believe that it should be left up to the journal to make decisions on the publication in question. The journal and the publication were exposed for a lack of credibility and for not meeting necessary scientific standards, which leaves them in a difficult position to defend. Due to the two-fold nature of the problem, scientific deficiencies and lack of procedural integrity of the Zeljenkova et al. (2014) paper, Testbiotech is urging the sponsor of the study, the EU-Commission, to seek ways of resolving this problem.

Testbiotech is also warning that other projects funded by the EU Commission have similar deficiencies. In a GRACE feeding study maize MON810 is being fed for one year to rats, whilst a further feeding study using maize NK603, which is resistant to glyphosate, is being conducted within a project called G-Twyst. This project led by Pablo Steinberg has already been heavily critisised for his role in the publication process of Zeljenkova et al. (2014). In future, both studies might be of relevance for setting future standards in the EU risk assessment of genetically engineered plants. Testbiotech therefore requests that all these studies are conducted with highest standards for scientific quality and independence of experts.