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EU Directive 2001/18/EC (which is currently under review) prohibits a GMO(1) being placed on the market in the EU unless it has been tested and authorised pursuant to detailed scientific assessments that measure the associated risks to human health and the environment.
Further to such assessments, authorisation was granted in 2003 to Monsanto for the sale in the EU of "NK603". NK603 is a genetically modified maize which was modified in such a way as to be resistant to glyphosate, the active ingredient of Monsanto's pesticide product Round-up. Such resistance was intended to enable farmers to spray fields with Round-up in one go, thereby incurring significant cost benefits.
The Séralini et al paper
On 19 September 2012, the scientific journal Food and Chemical Toxicology published a research paper, prepared by molecular biologist Gilles-Eric Séralini of the University of Caen, France. The Séralini et al paper reports on a two-year study which concluded that NK603 maize and low levels of glyphosate pesticide induced severe adverse health effects in rats. In particular, the study monitored a sample of Sprague-Dawley rats which were fed NK603 (treated both with and without Round-up) and found that those rats developed tumours at a higher rate than the control group.
Criticism of study
However, the Séralini et al paper has been heavily criticised by many industry stakeholders who believe that Séralini, a widely known opponent of GMOs, is merely manipulating public opinion by spreading unsubstantiated concerns.
A number of significant issues with the study have been identified. For instance, Sprague-Dawley rats are in fact prone to developing tumours during their two-year life span, and whether NK603 was responsible for inducing those tumours is therefore inconclusive. Furthermore, the study does not comply with internationally-recognised protocols for conducting such experiments and the authors omitted to state any objectives for the study which failed to employ a commonly-used statistical analysis method.
Amongst those rubbishing the Séralini et al study are EuropaBio (the European voice for the biotech industry), the BfR (the German Federal Institute for Risk Assessment) and the European Food Safety Authority (EFSA), which was responsible for the previous safety assessments of NK603.
EFSA received a formal request from the European Commission to carry out a scientific review of the paper and to advise whether it contains any elements that should lead EFSA to reconsider its previous safety assessments of Monsanto's GM-maize.
In addition, Germany has been asked by the European Commission to carry out the assessment of the study in relation to glyphosate, since it is the Member State with responsibility for the evaluation of this particular active substance. Accordingly, BfR has asked the authors to provide the complete study report including the individual animal data and to provide answers to specific questions so as to allow further evaluation to be made.
EFSA, having conducted its preliminary review which it published on 4 October, described Séralini's study as being "of insufficient scientific quality to be considered as valid for risk assessment". EFSA is now ready to engage in the final part of the two-stage process which involves taking into account additional information sought from the authors.
However, despite repeated requests made by EFSA and BfR to Séralini et al for the provision of their research data, this information continues to be withheld.
Over 700 scientists and academics have since signed a petition urging Séralini to provide the data necessary for evaluating the study, and the Food and Chemical Toxicology journal has confirmed it will publish letters criticising the study in its forthcoming edition. Nevertheless, Séralini et al remain reluctant to furnish this information.
Further calls to ban GM-maize
In spite of the controversy surrounding the validity of Séralini's study, there have been separate calls by campaigners to ban NK603.
Member States are obliged, under Directive 2001/18/EC, to act in accordance with the "precautionary principle" to ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the release or placing on the market of GMOs. Accordingly, anti-GMO campaigners including Testbiotech, Greenpeace and Friends of the Earth Europe (FoEE) argue that, since severe doubts about the safety of these products have not yet been eliminated, there is an urgent need for the industry to conduct further investigations and to ban these products in the meantime.
FoEE has criticised EFSA for putting public safety before the interests of agribusiness, maintaining that "for the past decade, EFSA has consistently sided with the biotech industry and disregarded health or environment concerns about genetically modified crops" and has called for the European Commission to suspend all new GMO approvals. However, others disagree and the UK shadow environment secretary, Mary Creagh, has said that the UK must "keep an open mind" in relation to GMOs and the potential contributions they can make towards tackling food poverty.
This is clearly an area of much controversy, but in the absence of any strong evidence to support claims such as those made by Seralini, GMOs look set to remain. Just recently (further to Implementing Decision 2012/8651/EU) the European Commission authorised the placing on the EU market of a new GM-maize product, "MIR162", following a favourable opinion given by EFSA who concluded it was as safe as its non-genetically modified counterpart with respect to potential effects on human health and the environment.
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(1) Genetically modified organisms (GMOs) are organisms in which the genetic material has been altered in such a way that does not occur naturally. The release of GMOs into the environment, and the placing of them onto the EU market, is currently regulated by Directive 2001/18/EC, as well as Regulation 1829/2003 on genetically modified food and Regulation 1830/2003 on the traceability and labelling of GMOs.
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