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John Dalli

Commissioner for Health and Consumer Policy

GMOs : towards a better, more informed decision-making process

Debate on GMO Risk Assessment and Management

Brussels, 17th March 2011

Ladies and Gentlemen,

Honourable Members of the European Parliament,

Dear Colleagues,

It is my pleasure to welcome you today to this debate on the risk assessment and risk management of GMOs.

Our objective is to bring everybody concerned to the same table – Members of the European Parliament, NGOs, industry, scientists, policy makers, from one standpoint to the opposite – to debate openly. We want to listen to your questions or concerns.

My intention is to take duly into consideration the outcome of today’s debate towards better, more informed, decision-making.

Why do we need a debate?

Since I took up the duties as a Commissioner about a year ago, I made it clear that I am not in favour or against GMOs and that my approach is to follow science-based decision-making with thorough risk assessment in line with the legislation as its cornerstone.

The EU is generally considered to have the world’s strictest authorisation system of GMOs and we in the Commission are constantly seeking to further improve this system.

Despite these efforts, the authorisation procedure and the science behind it continue to be the subject of a lively and often controversial debate in the EU.

This, in my view, shows it is also critical for science, policy and society, to engage in constructive dialogue.

Two fundamental questions towards building trust into the EU authorisation procedure relate

  • To the independence of the risk assessment and

  • to the confidentiality of scientific tests carried out by companies.

Let me first make a few remarks to the "independence of the risk assessment": The legislation provides for companies to build a detailed dossier that is the stepping-stone for the assessment of risks by Member States and by the European Food Safety Authority (EFSA), and on which the risk management decision will be based.

The fact that the starting point of the risk assessment process is a set of scientific tests carried out by companies raises questions among members of the public about the reliability of these tests.

This risk assessment process does not only need to be independent and beyond reproach. It also needs to be perceived as such.

Let me explain how we try to achieve this objective:

  • EFSA has in place a whole set of procedures aiming to prevent conflict of interest that are systematically reviewed and, if needed, reinforced. I personally attach great importance to this element!

  • I have requested the Federation of the Biotech Industry "Europabio" to ensure that GM seeds are made easily available for researchers to repeat any tests that are part of the risk assessment; and

  • The Commission plans to finance independent studies that would repeat tests provided by companies for some GMOs.

As to the second issue concerning "confidentiality", there is also the false perception that companies keep an important amount of data secret by claiming it is confidential business information.

The rules regarding confidentiality of authorisation files limit to the absolute minimum the information that can be regarded as confidential.

This means that only names of people and the detailed genetic sequence may be kept confidential. All the rest, such as –for instance–tests on animals, cannot be confidential – it is provided to anyone upon request.

The risk assessors and risk managers of the 27 Member States have obviously access to the whole dossier (confidential and non-confidential information) from the very beginning of the risk assessment phase.

Companies, of course, need to continue proactively improving transparency and access to their data, and doing their utmost to provide, from the beginning, complete dossiers in line with the requirements of the legislation.

But the fundamental question is: How can we subsequently build up a risk assessment process that fully delivers the stringent requirements of the legislation and duly acknowledges the different scientific views? I see three main tracks to be pursued:

First, the science behind the risk assessment needs to be made more credible and inclusive.

This means that concepts and approaches need to be openly discussed and well explained. We should of course question them constructively, if a better alternative exists.

Let me draw an example with the strategy for risk assessment, which is often somewhat confusingly termed “substantial equivalence.”

I am convinced that there are a lot of misunderstandings, not least semantic ones, which lead some to wrongly believe that the potential risks of GMOs to health and to the environment are not adequately assessed!

In actual fact, the comparative approach followed in the risk assessment strategy is exactly the opposite.

A thorough comparison between a GMO and a conventional safe counterpart allows the identification of all the differences created by the genetic modification.

This, in fact, is the starting point of risk assessment. All these differences are then investigated in detail with respect to possible toxicological, environmental, allergenic or nutritional aspects.

This is a sound scientific strategy that is followed by all authorities throughout the world. It underpins our strict, differentiated system for assessing the risk of GMOs. There is no stricter alternative available to this comparative approach.

The second track concerns, the ongoing update to technical progress and reinforcement of the risk assessment guidelines. This requires the early engagement of scientists, stakeholders and the public through open consultation.

We have gone through this process for the food and feed guidelines, and have just launched it for the environmental risk assessment guidelines.

As I explained at a workshop organised in the European Parliament in January, we identified a number of key aspects during the process for the food and feed guidelines, listening to the views and concerns of Member States and stakeholders.

One such aspect, for example, concerns the 90-day studies with rats currently performed on a case-by-case basis. Work is ongoing to reinforce these studies through a specific protocol. I have asked my services to reflect on the whether there is a need to have such studies done in all cases.

We now want to listen to your views on these and any other issues, both for the food and feed guidelines and for the environmental risk assessment guidelines.

The third priority track, from a regulatory point of view, concerns policy makers.

For this purpose, after EFSA’s scientific revision, the Commission in close cooperation with the Member States transforms the guidelines into a draft legal document.

In the case of the food and feed guidelines, the proposal for a Regulation will be examined in the light of today’s debate and be adopted in the coming months.

The environmental risk assessment guidelines will also go through this two-stage process, first the scientific revision led by EFSA and then the transformation into a legal text.

EFSA carried out an extensive consultation in two rounds, involving NGOs, industry and other stakeholders, as well as Member States. The Commission will also demand stakeholders’ input once a draft legal text is ready. These, of course, include Members of the European Parliament.

Let me finally stress the importance of monitoring. We have to undertake effective monitoring of GMO cultivation by companies and by Member States to ensure the accuracy of scientific assessments and to refine our techniques for future assessments.

EFSA is revising its guidelines for post-market monitoring, which will be ready in July 2011. This updated chapter on monitoring will be subsequently integrated into the environmental risk assessment guidelines.

Experience with the food and feed guidelines indicates that transforming scientific guidelines into a legal text is a long and technically complex process.

We count on your active and constructive input with a view to achieving the swift adoption of these guidelines.

Ladies and gentlemen,

It is important that we tone down the debate on GMOs to the rational level, separating (where possible) identified risks from potential risks and facts from perceptions, and tackling them separately.

I am convinced that the engagement of scientists and policy makers from the initial stage of the risk assessment process will help us build trust in both the science and the policy process.

Upon taking office and responsibility for this dossier I recognized the need for a further re-enforcement of our actions to ensure that we leave no stone unturned to guarantee the safety of our system.

I would like to underline that underpinning resolute safety, efforts must be made to improve transparency and dialogue by all of us.

I am personally committed to active and better dialogue and look forward to a fruitful discussion, not only today, but also in future debates.

Thank you very much.

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