European Conference: EFSA and GMO Risk Assessment for Human and Animal Health and the Environment, Brussels

Catherine Geslain-Lanéelle

Distinguished guests, colleagues, ladies and gentlemen

Introduction
I would like to welcome you to Brussels for this European conference on the risk assessment of GMOs. Today’s event provides a valuable opportunity to bring together a broad range of expertise and a wide representation of interests in GMOs and I must say it is very encouraging to see that so many of you have accepted our invitation to what I hope will be a stimulating and informative event. We are very honoured and privileged to have such a strong panel of speakers for the next two days. They bring a wide range of perspectives and experiences from across the sector which will no doubt enrich our understanding of the issues we face.

Similarly, it is very pleasing to that we have such a full and representative audience here today. I thank you very much for taking the time to participate, particularly our non-European guests who have travelled a long way to be here. A special word of thanks also to the two Directors-General of the European Commission: Robert Madelin, Director-General Health and Consumers, for his opening address, and Karl Falkenberg, Director-General Environment, who will address us tomorrow.

Background
EFSA was established as the EU’s independent risk assessor in 2002. In relation to GMOs, our role is laid down by the EU regulatory framework and in particular in our Founding Regulation. EFSA’s core task is to independently assess any possible risks of GMOs to human and animal health and the environment. Like all fields in which we operate, we are guided by the principles of independence, transparency and scientific excellence and we are committed to operating in the most open and inclusive manner that we can practically achieve. In relation to EFSA’s role in this field, we should bear in mind that we cannot take decisions on authorisation. That is the remit of the risk manager.
Our experts act in an independent capacity to deliver our core mission of providing scientific advice to the risk managers. EFSA is neither pro- nor anti-GMO; our role is strictly limited to transparently providing scientific opinions on the basis of the scientific evidence.

Why are we here
Let me focus for a moment on our purpose here today and tomorrow. The field of GMOs is characterised by significant divergence in opinion among the various actors, low social acceptability and differing views on the potential benefits and beneficiaries of the technology. Like in other fields of EFSA's work there are remaining areas of scientific uncertainty which risk managers must take into account when taking their decisions. Our role is to clearly identify where the uncertainties lie, explain their significance and together with all interested parties, including the broader scientific community, work towards reducing these over time.

Frequently, we also find there is confusion on the role of EFSA in the authorisation process.

So first and foremost, this conference was conceived to clarify EFSA’s role in the risk assessment of GMOs and I am joined today by a number of colleagues who will describe our processes and approaches in detail. We are also very pleased to have several members of our GMO Panel who will give their perspectives on risk assessment methodologies.

But we are here not only to inform but also to listen and learn. We want to get as wide a range of views and experiences as possible. We are aware that our published opinions in this field are not as accepted as in others and we are sensitive to the differing views in this complex field. That is why we continue to strengthen our engagement with all stakeholders. The process of authorisation of GMOs highlights the need for openness and inclusiveness both for risk assessors and risk managers and in EFSA we have taken several initiatives to address this.

Member States are intimately involved in the risk assessment process and their comments are addressed in a special annex to EFSA’s scientific opinions. When a safeguard clause is invoked by a Member State, we meet with the Member State and their experts to discuss the scientific issues.

In May this year we convened a technical meeting with national experts to discuss scientific aspects of the risk assessment of maize MON810 and their input was very informative in the risk assessment of that particular GMO.

In recent years we have scheduled meetings with non-governmental organisations in Parma and these have proved to be a very useful platform to exchange views on scientific and procedural issues and the next one is scheduled for October 2. We also meet with applicants – industry – on an annual basis to ensure that they understand the guidance for preparing dossiers for GMO applications and to exchange views on procedural issues. We continually review and update our guidance for applicants to ensure that it reflects the latest scientific developments.

Another important tool that we use to engage stakeholders is public consultation. We have consulted with you on several GMO-related issues, for example recently in the context of the updates of our guidance document for the risk assessment of genetically modified plants and derived food and feed and also on guidance for statistical models for the analysis of the data from field trials, to mention but two examples.

The outcomes of those consultations have been taken into account during the finalisation of the scientific opinions.

Programme
The conference programme has been drawn up in the spirit of cooperation and dialogue. The first session has been designed to ensure that the key EFSA staff members involved in GMO risk assessment have an opportunity to provide a detailed description of their work. In addition, three members of the GMO Panel will give us their first-hand experience in GMO risk assessment. The first session provides two other crucial perspectives – that of a Member State – Austria, presenting its views on how to perform environmental risk assessment, and that of a risk manager, DG Environment, which will address the post-market environmental monitoring of GMOs.

The second session is devoted to environmental impact and we have striven to ensure broad representation from those with an interest in this field.

We are delighted to have speakers from the Organisation for Economic Cooperation and Development, the Joint Research Centre of the European Commission, Friends of the Earth, the European farmers association, Copa-Cocega, the biotech industry and finally we will hear the views of a Member State – Spain – in relation to GM crop cultivation. At the end of each session, we have devoted time for discussion and I am confident that the debate will be lively and stimulating.

Conclusion
In conclusion, I would like to thank you once again for participating in this conference and I trust that we will all benefit from it. We in EFSA will certainly be mindful that we use the outcomes to guide our future initiatives.

I would now like to hand over to Robert Madelin for the opening address.

Thank you.