Safety of Monsanto’s Synthetic-Toxin maize to be re-examined

The non-profit organisations Testbiotech (Germany) and GeneWatch UK have submitted a formal request to the European Commission re-examine market authorisation of a genetically engineered maize produced by Monsanto sold under brand Genuity VT Triple PRO Corn (event MON89034 x MON 88017) that produces a synthetic toxin, intended to kill insect pests. This maize was approved for usage in food and feed by the EU Commission on 17th of June. It produces a combination of three different insecticidal toxins, one of which is synthesised artificially. Further, the plants are made tolerant to the herbicide glyphosate (known as Roundup).

The organisations are filing a formal request for internal review of the EU Commission´s decision according Article 10 of Regulation (EC) No. 1367/2006 because the legally required high level of protection for consumers, farm animals and the environment are not met and legal requirements for monitoring of health effects have been ignored completely. They argue that the authorisation should be withdrawn.

"This maize produces a unique combination of insecticidal proteins. In the parts of this plant, a synthetic Bt toxin is produced. Its toxicity might affect a much wider spectrum of species than expected. Further combined effects have to be expected with the other toxins and the residues from spraying with the herbicide. These risks can impact both on health and the environment,” said Helen Wallace from GeneWatch UK. “But none of these risks were properly examined before approval was granted.”

The plants were not tested for health effects in feeding studies. Only a short term trial for its nutritional quality was performed in poultry. The residues from spraying with glyphosate formulations were also not considered by the European Food Safety Authority EFSA. There are further legal requirements for monitoring of potential health effects that were ignored by the EU Commission:

“No plan for monitoring as required by European regulation was made available that would allow identification of particular health impacts that might be related to the use of these genetically engineered plants in food and feed. There is not even a reliable method to measure the level of toxins produced in the maize and to trace the products within the market,” said Christoph Then from Testbiotech.

According the request prepared by the two organisations, this case is also of general relevance for the setting of risk assessment standards by EFSA that are currently under discussion before being adopted as EU regulations. This case shows that in general much more effort is needed to ensure the high level of protection for human health and the environment required by the framework of the EU regulations. Since this case is a precedent, the NGOs have the option of considering further legal steps such as a case at the European Court of Justice if the EU Commission reject their request for internal review

Currently, genetically engineered crops mainly enter the EU from North and South America as soya or maize for use in animal feed. Maize containing a single Bt toxin is also grown for use in animal feed in Spain. Numerous “stacked events” containing multiple Bt toxins and/or resistence to one or more herbicides are awaiting regulatory approval in the EU. Herbicide resistant “superweeds” are becoming a major problem for American farmers growing herbicide tolerant GM crops and pests are also developing resistance to the Bt toxins included in many GM crops. A recent Canadian study suggested that the assumption made by regulators that Bt toxins do not survive in the human gut may be incorrect.