?EFSA Is Neither Pro Nor Anti GMO?
25 Jul, 2007 12:06 pm
The European Food Safety Authority (EFSA) is the keystone of the EU risk assessment regarding food and feed safety. Interview with Suzy Renckens, head of the GMO panel.
EFSA GMO Panel provides the scientific advice that underpins EU authorization procedures on GMOs but it is the European Union Member States and the European Commission who take the decisions whether or not to approve a given GMO. EFSA does not decide on market approval for GMOs.
EFSA’s role is to evaluate the safety and environmental impact of GMO. Individual GMO applications are assessed by EFSA’s GMO Panel which also provides scientific advice to the European Institutions and Member States on GMO issues. EFSA’s role in the risk assessment of GMOs is defined within the European regulatory framework for GMOs. EFSA exercises its responsibilities upon two distinct legal bases: Regulation (EC) No. 1829/2003 on genetically modified food and feed, and Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. Under the Directive, environmental risk assessments are initially carried out by Member States and EFSA only becomes involved if Member States have diverging views on the risk assessment of the Member State that conducted the initial risk assessment. Under the GM food/feed regulation EFSA has a more central role in the regulatory process following a consultation with the EU MS.
What are the conclusions of EFSA so far on the risk assessment of GMO?
EFSA’s GMO Panel scrutinizes each and every application according to established detailed guidance and extensive criteria. Overall, the GMO applications received by EFSA to date provide data of scientific quality that allow the risk assessment of the GMO in accordance with the EFSA guidance. Nevertheless in each GMO dossier that EFSA has evaluated EFSA has taken a cautious and conservative approach and requested further data or studies wherever it has doubts concerning the application or the data package was not comprehensive enough. On each occasion the applicant has come back with the data lacking or further studies or clarifications requested by EFSA. In the applications presented to EFSA for evaluation to date, the scientific experts on EFSA’s GMO Panel have not identified adverse effects of a specific GMO that would require a negative opinion.
The French scientific research institute CRIIGEN and Greenpeace recently published a study that points to 60 significant differences between rats that were fed GM maize produced by biotech firm Monsanto and already approved in Europe and rats that were fed normal maize. What impact may this report have as far as EFSA is concerned?
At the request of the European Commission (EC), EFSA has examined a paper by Séralini et al. on the statistical evaluation of a 90-day feeding study in animals with genetically modified maize MON 863, to identify any consequences for EFSA’s risk assessment of the safety of MON 863. The paper presents an alternative statistical analysis of the 90-day rat study that was considered in the original risk assessment. Following a detailed statistical review and analysis by an EFSA Task Force, EFSA’s GMO Panel has concluded that this re-analysis of the data does not raise any new safety concerns.
The main conclusions of the Panel were:
- The statistical analysis made by the authors of the paper did not take into account certain important statistical considerations. The assumptions underlying the statistical methodology employed by the authors led to misleading results.
- EFSA considers that the paper does not present a sound scientific justification in order to question the safety of MON 863 maize.
- Observed statistically significant differences reported by Monsanto, Séralini et al., and EFSA, were considered not to be biologically relevant. In the absence of any indications that the observed differences are indicative of adverse effects, the GMO Panel does not consider that this paper raises new issues with respect to the safety of MON 863 maize. Therefore, the GMO Panel sees no reason to revise its previous Opinions that the MON 863 maize would not have an adverse effect in the context of its proposed use.
Germany recently suspended the commercialization of one type of genetically modified Maize produced by Monsanto (Maize Mon 810) while France finally decided to carry it on. Were you requested an opinion on this issue and what was it?
We understand that Germany has raised specific issues with regard to the post-market monitoring of this maize. Recently, the applicant has submitted a renewal application to request the continued placing on the market of MON 810. That application also contains a post-market environmental monitoring plan therefore this issue will be considered by the GMO Panel and the risk managers.
EFSA is also responsible for communication to the general public. What do you recommend to improve public information on the GMO issue?
EFSA is committed to ensuring that all interested parties and the public at large receive timely, reliable, objective and meaningful information based on the risk assessments and scientific expertise of its Panels. All EFSA scientific opinions are published on our website, along with other information including fact sheets and background documents.
EFSA is neither pro nor anti GMO and we are conscious that debates around GMO issues often go beyond the scientific risk assessment work of EFSA and are often for risk managers and other decision makers. Public information comes from many different groups with an interest in the issues. It is important that EFSA is clear in our communications on our expert scientific opinions, addressing the evidence and reasons behind the independent advice that we give. Public understanding is always better informed when all parties adopt such an approach, so that the public can understand an issue and reach informed judgments.
Dr Suzy Renckens is head of the European Food Safety Authority's GMO Unit and Scientific coordinator of the scientific expert panel dealing with GMOs.
Interview by: Clementine Fullias