Risk assessment of genetically engineered plants deemed insufficient

The EU Parliament has in recent years adopted around 40 resolutions against further approvals for the import of genetically engineered (GE) plants. One of the criticisms was a lack of adequate and sufficient risk assessment. Experts of several member states raised similar criticisms. Nevertheless, the EU Commission gave the green light to all these imports. The results of the international research project RAGES now show that the concerns of EU Parliament are fully justified.

The RAGES project (Risk Assessment of Genetically Engineered Organisms in the EU and Switzerland) was carried out between 2016 and 2019. It critically evaluated risk assessment practice of genetically engineered (GE) food plants at the European Food Safety Authority (EFSA) and its Swiss counterpart. RAGES focused on the risks of transgenic plants intended for food production and also took some new methods of genetic engineering (genome ‘editing’) into account. The European Network of Scientists for Social and Environmental Responsibility (ENSSER), its Swiss branch CSS (Critical Scientists Switzerland), GeneWatch UK and Testbiotech participated. The project was funded by the Mercator Foundation, Switzerland and was completely independent of the interests of the biotech industry.

Currently, discussions on the risks are largely dominated by the perspective of the agbiotech-industry. These companies fund and control most research projects on transgenic plants and also generate data for the approval process. In addition, they have considerable influence on regulatory authorities. At the same time, they are trying to create the impression that all risks associated with GE organisms can be strictly managed and controlled, and that the safety of their marketed products has been demonstrated. Consequently, there is a high probability that risks are disregarded and/or relevant findings are overlooked by the current regulatory system. In this context, RAGES provides an urgently needed counter-perspective, giving priority to the protection of health and the environment.

Currently, more than 70 genetically engineered plants have approval for import into the EU. Most of these genetically engineered plants have more than one genetically engineered trait. One typical example is “SmartStax” maize, developed and marketed by Monsanto (Bayer) and DowDupont (Corteva): it produces six insecticidal Bt toxins and is tolerant to several herbicides. The gaps in current risk assessment can be exemplified by the fact that this maize was allowed for import into the EU without a single feeding study with the whole food and feed to assess its potential health effects.

The outcomes of the RAGES project show how risk assessors in the EU and Switzerland are actually failing to deal with the real and more recent problems. In many cases, they are following a ‘don´t look, don´t find’ approach that does not take the limits of knowledge into account; neither does it identify crucially important uncertainties or knowledge gaps. EFSA assessment does not by a long way look at all the relevant risks; it is mainly concerned with the risks than can be examined most easily.

Consequently, current standards of risk assessment are not sufficient to fulfill the legal requirements determining the safety of genetically engineered organisms or the food and feed derived thereof. This has to be “adequately and sufficiently demonstrated” by applying the “highest possible standard” of “any risks which they present”.

The results of RAGES project were presented at a conference on 29 October in Switzerland in which the EU Commission, EFSA and Swiss authorities participated. The final project reports will be published in early 2020.