EFSA scientific advice to EC on new scientific information in relation to the risk assessment of genetically modified organisms

Question Number
EFSA-Q-2015-00474
Issued
29 October 2015
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Abstract

Following a request of the European Commission, the European Food Safety Authority (EFSA) reviewed a recent publication by Ayyadurai and Deonikar, 2015 (Do GMOs Accumulate Formaldehyde and Disrupt Molecular Systems Equilibria? Systems Biology May Provide Answers). The main arguments presented by the authors were the significant accumulation of formaldehyde and concomitant depletion of glutathione in Roundup Ready soybeans due to the genetic modification when applying computational model simulation of important biological pathways. EFSA considers that the applied computer model is exclusively based on theoretical considerations, and that no empirical evidence is provided to support the model predictions.

EFSA addressed one-by-one the technical issues involved, related to the model chosen, the lack of empirical data, and accumulation of formaldehyde and concomitant depletion of glutathione. Considering that the authors do not provide information on the input data and the algorithm used in the model, that the model is not validated, and that no empirical studies have been presented to support the predictions of the model, EFSA is of the opinion that the author’s conclusions are not supported. Therefore, EFSA considers that its previous risk assessment conclusions on EPSPS-expressing herbicide tolerant GM soybean events remain valid.

Summary

This technical report is the response to a mandate from the European Commission (EC) to evaluate scientific issues raised by a recent publication by Ayyadurai and Deonikar (2015). By applying systems biology and using a computational model, the authors predicted that a significant accumulation of formaldehyde and concomitant depletion of glutathione might occur in Roundup Ready soybeans due to the genetic modification.

The study described in the publication is exclusively based on theoretical considerations and on the use of a combination of literature search together with computational modelling of the C1 metabolism pathway and oxidative stress.

EFSA addressed one-by-one the technical issues involved, related to the model chosen, the lack of empirical data, and accumulation of formaldehyde and concomitant depletion of glutathione. Considering that the authors do not provide information on the input data and the algorithm used in the model, that the model is not validated, and that no empirical studies have been presented to support the predictions of the model, EFSA is of the opinion that the author’s conclusions are not supported. Therefore, EFSA considers that its previous risk assessment conclusions on EPSPS-expressing herbicide tolerant GM soybean events remain valid.

Published
3 November 2015