Scientific analysis finds that EFSA's opinion on Monsanto's MON810 Bt maize was unsound and concludes EU Commission should withdraw cultivation permit
In a new peer-reviewed paper, the GMO Panel of the European Food Safety Authority (EFSA) stands accused of giving "low-quality scientific advice" in its favourable opinion on the cultivation in the European Union of Monsanto/Bayer's GM Bt insecticidal maize variety MON810.
The maize is the only GMO approved for cultivation in the EU. Based on EFSA's opinion, the European Commission has decided to renew the authorisation for cultivation, in spite of the fact that 19 Member States have banned it from their territories and the European Parliament has demanded that the Commission withdraw its decision.
EFSA issued an opinion in 2009 stating that MON810 was as safe as non-GM maize regarding potential effects on human and animal health and posed a "very low" risk of adverse effects on non-target organisms and the environment.
But those conclusions are challenged in the new paper, published in Environmental Sciences Europe by the scientist Veronika Chvátalová of Masaryk University in the Czech Republic.
Chvátalová looked at EFSA's risk assessment of MON810, focusing on two non-target organisms, honeybees and earthworms.
Chvátalová found that "EFSA omits relevant available studies, selectively cites information, misquotes studies, fails to acknowledge uncertainties, fails to call for further research where needed, and fails to critically interpret studies and their findings".
GMWatch observes that while such failures could hypothetically be the result of simple incompetence, in the case of EFSA's opinion on MON810, they all tend in one direction: to claim, in the face of evidence to the contrary, that MON810 is safe. This suggests that EFSA's performance is not driven just by incompetence but by an intent to mislead the public and take industry's side on the safety of this GMO.
In one example from EFSA's honeybees risk assessment, Chvátalová found that the authority selectively used scientific information in a biased way. It only mentioned parameters that were not affected by exposure to the GM insecticidal protein in MON810, while it omitted one that was negatively affected.
In the risk assessment for earthworms, Chvátalová found that EFSA used double standards, only applying criticism to a study that reported an adverse effect and not to other studies that reported no adverse effects. EFSA also adopted the opinion of a review in which the study's method was criticised, even though the critique was irrelevant. This use of double standards, according to Chvátalová, "does not inspire confidence in the scientific rigour of the EFSA".
Chvátalová found that contrary to EFSA's reassuring conclusion on MON810, "the body of referenced evidence is insufficient to draw conclusions on risk" and that the authority's environmental risk assessment was "incomplete". She concluded, "Overall, the findings indicate that the reliability of scientific information and particularly its use by the EFSA GMO Panel produces low-quality scientific advice, which is inconsistent with the Authority Mission Statement."
Chvátalová also took aim at EFSA's record on conflicts of interest: "The GMO Panel that was responsible for issuing the favourable report on GM maize MON810 has been criticised for more than half of its members having a conflict of interests."
Chvátalová is not the first scientist to accuse EFSA of operating unscientific double standards in the context of studies on GMOs. In 2012 Dr Angelika Hilbeck and Dr Hartmut Meyer accused EFSA of double standards when it rejected the study led by Prof GE Séralini, which found adverse effects in rats fed a GM maize and very low levels of Roundup herbicide, while uncritically accepting at face value Monsanto's own studies on the same maize, which concluded that it was safe.
Yet when EFSA's own criteria for judging Séralini's study were applied equally to Monsanto's studies, all the studies were found to satisfy or fail to satisfy EFSA's criteria to a comparable extent. Drs Hilbeck and Meyer concluded, "The rejection of only one of the papers is, thus, not scientifically justified."
MON810: A history
MON810 maize was first permitted to be grown in the EU in 1998 for a 10-year period. In 2007 Monsanto applied for renewal of the cultivation authorisation, but a qualified majority of Member States could not agree to grant the renewal. The row dragged on until 2016, when the European Commission unilaterally issued a decision renewing the authorisation of the cultivation of MON810 maize.
However, later the same year, the European Parliament passed a resolution calling on the Commission to withdraw its decision. A group of NGOs agreed.
Chvátalová states in her paper that her research led her to support the Parliament's and NGOs' demand: "These results would support the call on the EC [Commission] to withdraw its draft implementing decision to renew the authorisation of MON810 cultivation voiced by the European Parliament and NGOs."
Nineteen EU Member States have made use of the EU's "opt-out" rule to pre-emptively ban the cultivation of MON810 maize on their territories. Spain is the only country that continues to grow it on any significant scale, with a small area in Portugal.
The new paper:
A critical evaluation of EFSA’s environmental risk assessment of genetically modified maize MON810 for honeybees and earthworms
Environmental Sciences Europevolume 31, Article number: 52 (2019)
In the European Union (EU), genetically modified (GM) crops are permitted for cultivation only after a thorough risk assessment and a decision by the European Commission (EC). The central scientific body assessing food-related risks is the European Food Safety Authority (EFSA). It aims to provide high-quality scientific advice for EU decision-makers. However, both the way EFSA performs risk assessment and the independence of its panel members have been subjected to consistent criticism. In this paper, I examine part of the environmental risk assessment in the Scientific Opinion issued by the EFSA GMO Panel, specifically, the impacts of GM maize MON810 on honeybees and earthworms. The evaluated EFSA document forms the scientific basis of the pending EC Draft implementing decision to renew the authorisation for the lawful cultivation of MON810. I assess the reliability of scientific information cited in the Opinion, the use of this information by EFSA, and the safety conclusions drawn in a form of an extended peer review.
My research indicates that the scientific studies cited in the EFSA Opinion in the sections concerning the possible impacts of GM maize on honeybees and earthworms stem predominantly from reliable sources in terms of authorship, financial support, and status of the study. However, the reliability of the studies varies significantly concerning the ecological relevance of the experiments. Moreover, the body of referenced evidence is insufficient to draw conclusions on risk. Relevantly, several types of shortcomings in the use of scientific information in the risk assessment were identified as prevalent, namely: EFSA omits relevant available studies, selectively cites information, misquotes studies, fails to acknowledge uncertainties, fails to call for further research where needed, and fails to critically interpret studies and their findings.
Overall, the findings indicate that the reliability of scientific information and particularly its use by the EFSA GMO Panel produces low-quality scientific advice, which is inconsistent with the Authority Mission Statement. My research would support the call by the European Parliament and NGOs on the EC to withdraw its Draft implementing decision intended to renew the authorisation of MON810 cultivation.