Select Committee on European Communities Minutes of Evidence

Examination of witnesses (Questions 480 - 485)



  480.  Was there a requirement for such consultation in this case?
  (Dr Smith)  Unless the company applied for consent to release the fish ACRE would not have been consulted. However, my department is free to consult ACRE about any matter of concern. In this case the level of containment was considered to be satisfactory to prevent release.

Lord Wade of Chorlton

  481.  In the event, the containment proved to be satisfactory and there was no release. Your assessment as to the safety of the containment proved to be correct?
  (Dr Smith)  Indeed.

Lord Jopling

  482.  The European system for granting marketing consents has been extraordinarily slow. We understand that that has been due largely to political considerations and the variety of opinions among Member States. We have been told that this has had a harmful effect on the European scientific industry and on its agriculture. Are you concerned about what is happening in Europe? Are there any ways in which changes can be made to ensure that the process achieves what I regard as almost the impossible; namely, a more open, transparent, safe and speedy system?
  (Dr Smith)  There have been extremely long delays in the European Union in relation to marketing matters. If one takes experimental releases, they have all been considered within the United Kingdom statutory timescale. For marketing consent the timetable in the directive places a very tight time constraint on the countries that have to make the initial assessment: 90 days. The time for other Member States to consider the dossier is 60 days. If there is not agreement among Member States to allow the product to be given marketing approval it then goes into the Commission procedure. That is where the greatest delay takes place. The delay has been as great as several years. Ministers have been extremely concerned about this. My Minister wrote as recently as last autumn to the Commissioner of DGXI to complain about the time taken. The European Commission has started to move products forward. The impasse was resolved by the use of the European scientific committees. They are proposed to be brought into the system under the amended directive. As to those marketing cases that gave rise to the backlog, the dossiers were submitted to the scientific committees who were able to give their opinion. Some of the products have moved through. The United Kingdom gave approval for marketing two products on 9 June of this years. That was concerned with the import of grain from North America. Under the existing directive we hope that matters are moving forward. The Commission's proposals for the revision of the directive will place a very strict timetable on the Commission for the following stages if Member States cannot agree. If and when the amended directive is adopted the situation should improve. In answer to your question as to how we can ensure that there is an open, transparent and quick process, this is a very difficult issue. As to openness, the Government have public registers for all the applications for marketing consents. We also make available the whole dossier to the public, although we keep confidential any commercially sensitive material. Usually once the product has come onto the market the question of intellectual property rights has been settled. The advisory committee's advice is made public. We are taking further steps to ensure that is made transparent. But the decision process within the European Union perhaps needs to be made more transparent. That is one of the matters that will be addressed in the amendment of the directive. This is an extremely controversial area. Certainly, there is not full agreement among the public as to whether these products should be put onto the market. At present the authorities are assessing the safety for human health and the environment. Whether people want these products is a different issue which is outside the regulatory process.

Lord Gisborough

  483.  Due to objections to this technology by a number of Member States, might subsidiarity be used to take the heat out of the problem, perhaps for growing if not for marketing? Would it be more practical for Member States to opt out after EC approval or for Member States to be allowed to give their own commercial consents?
  (Dr Bell)  The plain fact is that under EU treaty rules there are no grounds for Member States to be allowed to grant their own consents. That would conflict with the single market arrangements for trade within the Union. That option is not therefore currently open to us. However the Government see no reason to stop the cultivation or use of GMOs where they have been approved for sale following a full safety assessment. They would not wish to operate on any other basis. A ban on non-safety grounds would be very likely to be open to challenge under the rules of the World Trade Organization because a ban on cultivation effectively amounts to a ban on trade in the seed. The Government are aware of the very wide range of public opinion in relation to genetic modification. For that reason they have initiated a public consultation exercise that is about to get under way, the preliminary work having now been completed. This aims to explore people's views in more detail and is being organised by the Office of Science and Technology which comes under the control of Mr Battle. The intention is to get behind the media headlines and find out what the public are concerned about and, more importantly, why. We do not understand fully at this stage the principal concerns. We hear a lot about a wide range of concerns, but it is necessary to carry out a more detailed analysis to discover exactly what the concerns are and the basis of those concerns. As far as the farming community is concerned, we are very well aware that it has raised concerns about not being able to have access to the technology within the same timescale as others. That must also be weighed in the balance. The general view is that it is difficult to see how policies requiring farmers to grow less cost-effective varieties than those being used elsewhere can be sustained beyond the short term in a world trade situation. A number of factors therefore have to be taken into account. Our room for manoeuvre is fairly limited because of European Union and, more particularly, world trade agreements.

Lord Grantchester

  484.  Turning to the pattern of international trade, we have already seen problems arising from different attitudes and speeds of development of this technology notably in Europe and North America. The European position in relation to GMOs is constrained by the Convention on Biological Diversity and the World Trade Organization. What do you see as the detrimental aspects of the current restraints of these agreements? What international developments are most necessary in the near future?
  (Dr Smith)  To start with the Convention on Biological Diversity, that convention requires the contracting parties to establish means of regulating or controlling the risks associated with the use and release of what are called living modified organisms which are likely to have adverse environmental and human health impacts. The EC legislation covering GMOs serves to implement this requirement under the convention. The Government do not see the obligation as a constraint but as a welcome measure that will foster the safe use of biotechnology worldwide through the exchange of information. The current major constraint of WTO rules is their lack of clarity as to how parties can invoke general exceptions under Article 20 of GATT which is concerned with human, animal or plant health. The developing case law is helping but it will take time to establish clear ground rules. The international development most necessary in this area is the conclusion of the negotiations on the bio safety protocol which has been worked on under the Convention on Biological Diversity. The final meeting on the protocol is planned for February of next year. This was agreed by the contracting parties to the convention in May of this year. We hope that there will be rapid implementation of that. That will help to promote safety and avoid the creation of trade barriers.
  (Dr Bell)  Referring to the World Trade Organization rules, the SPS agreement is currently being reviewed. The present position of the Government is that they do not expect a significant change in the way that that operates in terms of its dependence on scientific information. That is still considered to be the most effective way in which the agreement can work on a worldwide basis. Constraints are built into that to take other matters into consideration. Having said that the rules are based on science they do embody the right of countries to set their own level of protection, provided that that can be justified scientifically. It also allows for precautionary action to be taken. It is considered to be a reasonable basis on which to operate. No particular changes are likely to be sought in that respect.

  485.  Do you think that it will lead to a greater degree of compatibility between the two regulatory systems?
  (Dr Bell)  One would like to think so but it may be optimistic to make that assumption, certainly in the short term. We have not seen a great deal of that so far in this particular area, but it may be that as experience develops and GMO technology matures there will be an easier passage of products between the various trading blocs and more agreement as to how they should be assessed. A good deal of the problems so far have arisen because it is a new technology and one particular trading bloc has embraced it more enthusiastically than others. We wish to take a cautionary approach. But in the fullness of time it may be that the two sides will move closer on how the technology should be developed. Whether or not that will be spurred on by agreements of this nature is another matter. I am inclined to believe that that will happen independently of these agreements, although obviously all countries are expected to abide by them. The Government are determined that the United Kingdom will abide by the agreements to which it has signed up.

Chairman]  That brings us to the end of the questions that we have time for this morning. Perhaps you would be so kind as to supply us with written answers to the outstanding questions which we will supply and would have asked given time. You also said that you would be willing to provide some additional material. There are a couple of subjects on which it would be helpful to have the text of ACRE's advice: one is the story of the lacewing and the other is the proximity of the organic farm in Devon to a GM crop. Thank you very much for coming here and giving us extremely useful evidence.


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