Send Add comment

GMO authorisation procedure in the EU: The next reform?

“On paper there is a clear division between science and politics. But the reality is different.”

The EU legal framework and the procedure for authorising genetically modified crops are being criticised and some member states have made various reform proposals. GMO Safety spoke to Maria Weimer, a PhD student at the European University Institute in Florence.

Maria Weimer is a law graduate and has been researching the way the law deals with new technologies, scientific uncertainty and risks for years. She is currently completing her PhD at the European University Institute in Florence in which she is researching the application of the precautionary principle in the EU regulation of GMOs. Her other research areas are public administration law, EU law and governance. In the past she has also worked as a journalist for NDR and Spiegel magazine in Hamburg.

GMO Safety: For several years there has been a binding EU-wide legal framework for the authorisation of genetically modified organisms (GMOs). Some member states are obviously unhappy with it and have announced proposals for a reform. What are the criticisms?

Maria Weimer: The criticism is wide-ranging. First of all, a distinction needs to be made between criticism of the work of the scientific body for food safety (EFSA) and criticisms that relate to risk management, i.e. the work of the Commission and Council. The key points of the criticism concern the independence of EFSA, the insufficient involvement of national experts in risk assessment and the decision-making blockades in the Council.

First of all, we need to be clear about one thing: the procedure that we have today was agreed on in 2001 and 2003 by the then member states. This means that they were the principal authors of the current legal framework along with the European Parliament. Insofar they shared responsibility for the procedure. Today many member states, perhaps even a majority of them, are severely critical of the procedure regulations. Yet the scientific situation has not really changed very much. There are no significantly new scientific findings on risks posed by genetically modified products.

GMO Safety: The current authorisation procedure for GMOs does not inspire confidence. EFSA’s scientific safety assessment is used as a basis for drawing up a decision proposal, but the member states block each other in the Council of Ministers when it comes to a vote. Some of them are in favour while others are against. How can we get out of this situation?

Maria Weimer: By first of all realising what is causing the blockade. From a legal point of view one could say that the majority situation, as currently provided for in the procedure, is not an effective way of arriving at a political decision. The ministers have to achieve a qualified majority if they want to accept or reject the Commission’s decision proposal. Because the risk management procedure states that the Council should not take the final decision on its own, and neither should the Commission. Rather, both should decided together.

One could consider whether the majority situation should be changed in future. However, I think that this problem is only superficial. At the end of the day, what lies behind it is the confusion of the debates and the mixing of political and scientific arguments.

“This mood cannot be changed by scientific expert opinion alone.”

GMO Safety: Political debates about plant genetic engineering often take the form of apparently scientific disputes. Sometimes one has the impression that scientific findings e.g. about the safety of GM plants, are undermined by political decisions. How could one achieve a better, clearer separation between the scientific and political levels?

Maria Weimer: I think that it is a difficult relationship. Firstly, under the current legal situation there is a wonderfully clear separation between science and politics at the procedural level. This was in fact one of the key aims of the last reform: EFSA is exclusively responsible for the scientific risk assessment and the Commission and the Council for risk management, in other words for the decision in favour of authorisation or against it, based of course on the risk assessment. In other words, the separation exists on paper. Unfortunately, the reality is somewhat different, both within the decision-making process and in the debates carried out within the member states.

I think people hope science will give a legitimacy that is otherwise difficult to obtain. At the end of the day, a much more pressing issue than the scientific concerns about environmental and health risks is that of whether EU citizens want GMO products. It seems to me that people do not want them, which is understandable: They don’t see the advantage to them; they don’t see why they should get involved with the uncertainty of this new technology. This mood is reported as something that can be changed by scientific expert opinion. Politicians should really be more open about it and hold a political debate about the advantages and disadvantages of GMOs for society.

GMO Safety: If there are no obvious safety problems, legally the member states have hardly any leeway to object to a GMO product. Yet politically, governments want to take their own decisions taking into account the attitude of the population. Can this area of conflict be resolved?

Maria Weimer: There are no simple solutions here, but it is clear that the harmonised legal framework, and the fact that the member states belong to the World Trade Organization (WTO) mean that the member states can go their own way only if there are new scientific findings. Through the WTO the member states have committed themselves to not allowing any trade restrictions that do not have a scientific justification. This is also the thinking behind the harmonised legal framework that the member states agreed at the time. With it, they surrendered their authority in this area to the EU and submitted to stricter requirements concerning unilateral actions at national level. The aim was in fact to enable free trade in GMO products whilst ensuring a high level of health safety.

“The member states cannot adhere to a harmonised framework and at the same time desire to take their own decisions at local level.”

GMO Safety: The German minister of agriculture, Seehofer, and the CSU want the EU to be responsible only for authorising genetically modified crops. The regions – e.g. German federal states or administrative districts – would then decide whether a plant could be cultivated.

Maria Weimer: Politically that is not unappealing. If the local authorities decide, it looks like subsidiarity. However, from a legal point of view it is more difficult. Subsidiarity means that decisions are taken at local level if they can be taken more effectively at local rather than at central European level. Five to seven years ago it was thought that the EU could do it better, which is why the legislation was created.

There are areas that are not legally harmonised at EU level. In these areas the member states have somewhat greater autonomy and can cite various reasons for limiting the free circulation of goods. However, if you harmonise an area and create a law at European level and a common procedure, as is the case with GMOs, then you submit to stricter requirements. At the moment the situation is that a member state can deviate from the common decision only if there are new scientific findings. However, if the procedure is reformed, it would be possible to consider introducing clearly defined exceptional cases in order to take account of specific local conditions, such as nature conservation areas.

To summarise, the Bavarian proposals contain a very clear legal and logical contradiction. The member states cannot adhere to a harmonised framework and at the same time desire to take their own decisions at local level, e.g. to create ‘GM-free’ zones. That is at odds with the principle of the free circulation of goods for GMOs. In that case, it would be logical to remove this area from the harmonisation, but I don’t think that this in an option either legally or politically.

“Science cannot make all decisions for society.”

GMO Safety: Another proposal is to take account of socioeconomic criteria as well as scientific criteria when taking decisions about the authorisation of GMOs. Wouldn’t there be a risk of such ‘soft’ criteria being used arbitrarily?

Maria Weimer: The way you phrase the question assumes that only decisions with scientific justifications are hard and fast. If something is decided according to other criteria, then it is ‘soft’ and arbitrary. I regard that as something of a simplification. From sociological research we know that the scientific process is also a social process. Scientific research and its findings are not purely objective, but are also shaped by the scientists’ values and beliefs and by the task that the scientists have been commissioned to carry out by politicians. This means that science does not deliver such a hard and fast, objective basis for decision-making as one might like to think.

Including socioeconomic criteria in the authorisation of GMOs, as is currently being demanded by France, is nothing new. According to current law, the Commission can cite other ‘legitimate factors’ when deciding whether to authorise a GMO on the basis of the EFSA assessment. Precisely what these factors are is not clearly defined, but it is clear that they must be non-scientific factors. In practice, I guess, these factors are either not taken into account, or not openly. Socioeconomic aspects – e.g. considering the impacts that the cultivation of GM seed would have on conventional agriculture in a particular territory – are camouflaged under the cloak of scientific factors. If the GMO authorisation procedure is reformed, it is important that people agree openly which considerations can be included in the decision-making process in addition to environmental and health risks and their scientific assessment. Any such factors would have to be clearly formulated and there would have to be procedural guarantees to ensure that they are considered in a transparent manner. One of the reasons this is so important is that science cannot take all decisions for society.

GMO Safety: But what could such ‘legitimate factors’ be? And how does one ensure that they can be assessed in an objective, comprehensible manner? Isn’t there a very real risk of arbitrariness?

Maria Weimer: The factors could be economic, social or ethical considerations, but could also concern social traditions, such as eating habits. One avoids arbitrariness on the part of public administration by instituting control mechanisms. In the case of GMO authorisations these might be the scientific risk assessment or greater public involvement. For instance, the Commission could be obliged to justify in what way it has taken into account public comments when making its authorisation decision. This is not the case at the moment. At the end of the day though, we have to allow the authorities some discretion and trust that they will not use it arbitrarily. And of course we need effective legal protection.

GMO Safety: Is it legally possible to change the GMO authorisation procedure in the short-term? Or would it require time-consuming amendments to the relevant EU regulations?

Maria Weimer: The existing regulations can be changed only through the same channels that were used to create them. The Parliament and the member sates must agree with a majority in favour. In the case of the member states, they actually need a qualified majority. There is no other way.

GMO Safety: Thank you for talking to us.

Discussion / Comments

Comments are being loaded…