Double standards in the safety assessment of genetically engineered soybeans

Transgenic plants are not being tested according to current EU regulations

29 May 2020 / In December 2019, the EU Commission decided to renew two market approvals for genetically engineered (GE) soybeans produced by Bayer. The soybeans (MON89788 and A2704-12) are resistant to applications of the herbicides glyphosate resp. glufosinate. The soybeans were first allowed for EU import more than ten years ago. Testbiotech has asked the Commission to withdraw the decision extending market approval. The reason: the risks associated with the GE soybeans were not assessed in accordance with current EU standards.

Higher standards in the EU risk assessment of GE plants came into force at the end of 2013. Amongst other things, 90-day feeding studies with whole food and feed have been a requirement since then. Further, field trials with the plants have to be carried out under conditions representative of real agricultural conditions. Neither of the above criteria were fulfilled in the data provided by Bayer. No feeding trials were performed at all for one of the GE soybeans (A2704-12). The other GE soybeans (MON89788) were tested in feeding trials, but these had substantial methodological flaws. No data were made available for either of the soybean varieties from field trials representative of the actual practice of herbicide application, or climatic conditions under which the plants are cultivated.

In their reply, the Commission does not deny these data gaps. However, the Commission does claim that the higher standards in risk assessment only apply to new authorisations. For decisions on renewals, normally taken ten years after the first authorisation, lower standards can be applied. This legal opinion seems to contradict the wording of the respective Regulation (Commission Implementing Regulation 503/2013) which states: “To ensure that applications for renewal meet the same standards as regards tests methods, it is appropriate that these requirements also apply to application for renewal of authorisation of GM food and feed.”

If the legal opinion of the EU Commission is correct, GE plants that are re-approved will never have to be tested according to the current regulations. Consequently, double standards would be allowed in the EU safety assessment of transgenic plants. Testbiotech has now exposed this unacceptable situation in a new letter to the EU Commission.

In this context, Testbiotech is once again calling attention to another major gap in recent EU risk assessment practice: if GE plants are crossed to produce plants that have been genetically engineered in several parts of their genome, they will, in many cases, be resistant to several herbicides and might, in addition, produce insecticides. However, no testing of the combinatorial effects is required. This problem is highly relevant: many more than half of the 80 types of GE plants currently allowed for import into the EU inherit such a combination of transgenes.

These gaps and other flaws in current risk assessment practice were recently highlighted in the findings of the RAGES research project. Upon request of the EU Commission, the European Food Safety Authority (EFSA) is supposed to draw up a report on the RAGES findings by the end of June. Testbiotech demands that the EU Commission carries out its own independent analysis, since EFSA has, so far, always shown that its priority lies in defending its own standards.

Christoph Then, Tel +49 151 54638040,