Share this:

EU Members State critiques and leaked industry documents uncover safety questions

Ottawa, June 28, 2011. German group Testbiotech today released a critical new report that exposes unstudied questions in confidential industry documents from Monsanto and Dow AgroSciences on their genetically modified (GM) eight-trait corn called “SmartStax”, approved in Canada in 2009.

The GM SmartStax corn produces six different insecticidal toxins and is tolerant to two herbicides. It was allowed onto the market in Canada without a safety evaluation from Health Canada.

Testbiotech gained access to some confidential science evaluations prepared by Monsanto and Dow AgroSciences and presented to the European Food Safety Authority (EFSA) for risk assessment of the GM corn. The group also examined a series of critiques from EU Member States of the EFSA decision and industry documents. In September 2010, EFSA declared the GM corn safe for human and animal consumption. However, the Testbiotech report concludes that the investigations carried out by industry were inadequate for examining health risks.

“Unlike European regulators, Health Canada didn’t even pretend to assess the safety of this new GM corn. The department just presumed that Monsanto’s SmartStax corn is a harmless amalgam of eight previously approved GM traits,” said Lucy Sharratt of the Canadian Biotechnology Action Network, “The new report exposes the depth of Health Canada’s ignorance on the safety of SmartStax corn. The significant human health and environmental risk questions raised by EU Members States were never asked by Health Canada.”

“The documents show alarming deficiencies in risk evaluations performed by both industry and EU regulators,” said Christoph Then of Testbiotech. “The documents reveal insufficient assessment of risks to human and animal health. For example, the corn was fed to poultry to test nutritional efficiency but there was no investigation of potential health risks.”

Today’s Testbiotech report also states that, “The industry dossiers not only have major defects in study design, they also lack independent quality controls.” In their report, Testbiotech raises the question of possible manipulation of data as one industry document states that, “…oversight ensured that the data were consistent with expectations.” The science submitted by industry is not peer-reviewed.

The data show a tenfold or even twentyfold variation in the content of the insecticidal toxins. The exact range of variation under changing environmental conditions was not determined, leaving questions about the genetic stability of the GM corn plants. There are no evaluated protocols to enable independent measurements of the content of the toxins.

“EFSA based its conclusion of safety to a large extent on data derived from the parental plants. But this approach is highly complicated since SmartStax has many insecticidal toxins, thus more interactions can to be expected. These interactions remain unstudied,” said Then. “Despite this limitation, the results of the risk assessment of parental plants alone show a wide range of uncertainties. For example, in one case even damage in kidneys is under discussion.”

“The critical comments from European countries provide important insights into the limitations of Monsanto’s data and the questions that Health Canada shrugged off,” said Sharratt. “Health Canada needs to immediately remove authorization for SmartStax and begin the human health risk assessment that it never bothered to perform,” said Sharratt.


For more information: Christoph Then, +49 151 54 63 80 40, ; Lucy Sharratt, Canadian Biotechnology Action Network, 613 241 2267 ext 25

Link to the report and the documents:

Background on SmartStax in Canada

Media Backgrounders: