Select Committee on European Communities Minutes of Evidence


Examination of Witness (Questions 200 - 222)

WEDNESDAY 17 JUNE 1998

MISS JULIE HILL

  200.  May I move on to my question which looks at the question of monitoring, particularly the monitoring of GM crops after commercial consent. This is something that you argue for. How do you see this actually happening in practice? What would you be monitoring, measuring? How would you set the standards of measurement that allowed you to decide that it was a good thing or a bad thing?

  A.  The key principle of monitoring is that we should be able to revisit the key assumptions made in risk assessments when a crop is given commercial consent. At the moment, the few crops which have been given commercial consent are going ahead on the basis that we have a certain level of confidence that they will only cross-hybridise with wild relatives at a certain rate, or the genes will only persist in volunteer populations of the crop at a certain level. Now, all of those are assumptions based on a body of scientific knowledge about natural selection and the movement of genes. They are not judgments based on any kind of empirical data on the large-scale growing of this kind of crop, precisely because they have not been cleared for commercial use before. So we are assuming certain things will hold true when these crops are grown on a large scale, based on key scientific assumptions and a small set of empirical data from field trials. Now, it seems to me sensible that when crops are grown on a commercial scale, to revisit those assumptions to see if they hold true. Things like hybridisation with wild relatives and persistence of genes are measurable. It is difficult to set up the experimental protocols which would do that measuring accurately and to people's satisfaction but it is not impossible, in my view. We should be able to come to an agreement between the scientific community, the industrial community and the organisations who have an interest in the environmental impacts, on actually what we should measure: what is important and how to do it. I do not have ready answers to that as yet. The Green Alliance is organising a workshop later on this year with scientists and with non-government groups to discuss precisely that: what could be feasibly and usefully measured? We must make some effort to check our assumptions. Otherwise, it is like conducting a huge uncontrolled experiment without any means of checking the result.

  201.  Who do you think would be responsible for doing this and where would the cost fall?

  A.  That is also a matter for considerable debate. I think there is probably a mixture of responsibility for Government, for the industrial interests, and possibly also for the farming community. When I say "responsibility" I do not just mean cost responsibility but broad responsibility. I do not want to prejudge that. I hope we can find some feasible agreement on that; about what is the right allocation of responsibility.

Lord Gisborough

  202.  Is there a role for Government in requiring or assisting the segregation of GM products down the food chain?

  A.  I should stress that our primary interest is environmental rather than food and consumer choice. Nonetheless, I do believe in consumer choice. I am not sure our Government could unilaterally require segregation of crops coming in from abroad but I think it should certainly encourage it. On a United Kingdom basis, our Government should at least require traceability which is a first step towards segregation. What I mean by that is that it should be a requirement to record where GM crops are grown. That kind of traceability would enable segregation by growers and processors and retailers, if they wanted it, but would also enable environmental traceability, if you like. If we are going to go in for any meaningful monitoring, at least we have to know where GM crops are being grown.

Chairman

  203.  Is that feasible internationally or only within a single country?

  A.  I think it is only feasible internationally if individual countries are prepared to require it, or if agreement can be gained at a European level to ensure monitoring. Obviously, ideally, in most of my comments it is implied that we would be doing this across Europe. We would be improving the control of the technology across Europe, but in the absence of agreement in Europe I am sure the United Kingdom Government can take steps here.

Lord Rathcavan

  204.  Miss Hill, you appear to be satisfied with the transparency of the operation of United Kingdom regulation, although not with the degree of public awareness. In your note, in paragraph 13, you welcome some of the new moves made in Europe, but you indicate that in Europe also you would like to see greater transparency. What further changes would you like to see?

  A.  The draft revision of the Directive does put in place some better provisions for public access to information. Previously, it only required a very small set of information to be released by each Member State and, therefore, the extent to which Member States did provide information varied enormously from quite a lot in the United Kingdom and Netherlands, to almost none in some other countries. The recent revision allows for the Commission itself to provide summaries of applications for marketing consents, which are clearly the ones that tend to attract the most interest, but they are only proposing to allow 30 days for comment which is probably, on the United Kingdom experience, not long enough. Something like 60 days would be more realistic. There is also a new provision for assessment reports, which is a kind of summary evaluation of an application for marketing made by the Member State competent authority to which the application is first made. Our disappointment about that is that the Commission is only proposing to release the assessment reports after a decision has been made, which I think is definitely unhelpful. In fact, it is almost less helpful than not releasing any information at all, for people to feel that they can only get something once a judgment is finalised. My other anxiety about the Brussels system is the increasing use of central scientific advice. There are now committees set up in Brussels, under the auspices of DG XXIV, which have been called upon, in effect, to be the final arbiters on applications for marketing consents, where there have been disputes between Member States as to whether they should go ahead. This to me is damaging to the democratic accountability of the EU system, because each application goes through a scientific evaluation process in the Member State which is, at least to some extent, (certainly in the United Kingdom), accessible in the sense that one can see when the application is coming up for discussion. This is because agendas are published now. One would be able to get reports of the meetings and obtain copies of the dossiers from the Public Register. It seems to me, for the Brussels-based committees, that this is much further removed. One could pay a lot of attention to the scientific judgment process in the United Kingdom, for instance, and then a completely different judgment is made in Brussels. It seems, as yet, very unclear whether those committees are designed simply to resolve disputes and are, therefore, somehow meant to be the final port of call for an application; or whether they are actually going to re-rehearse all the evidence and have a completely different scientific judgment, (and a completely different scientific discussion possibly). In that sense, it seems unclear to me how accountable that system is. It is actually reasonably transparent, to some extent, because you can find out what the committee's deliberations were on the web site after the meeting—in some cases, I gather, even before the members themselves have seen it or have cleared the minutes, which again is slightly worrying. However, in terms of its accountability—the access to those committees, who is on them, how are they formed, what kind of job are they doing—I have anxieties as to whether this is operating in the public interest of the citizens of Europe.

Chairman

  205.  The composition is not transparent? Is that one of your criticisms?

  A.  The members of the committees are appointed, it seems, simply by their volunteering to sit on the committee. But it is very difficult for outside parties to influence an essentially Brussels-based committee. It is certainly less easy to influence or to understand its operation and to put views into it than it is if you have a committee sitting in your own country, where you can begin to build up at least some kind of familiarity with how the committee is working.

  206.  But how otherwise should the Commission deal with failure to reach agreement in council?

  A.  I think there should be every effort to resolve it between the Member States. If the problems are predominantly political, which is what they are; they are disputes about the acceptability of certain risks and not the scale of certain risks. That has been the nature of the disputes. Therefore, recourse to another body of scientists is not in our case going to solve that kind of problem. It simply adds up to a yes/no judgment which, anyone who has objected to beforehand, is unlikely to have confidence in.

  207.  But at least if it results in a decision, if you did not have them there would be even fewer decisions.

  A.  I am sorry?

  208.  If it results in a decision which you might otherwise not get.

  A.  Certainly the present system has not succeeded in resolving disputes, largely because the interpretation of the Directive, as we were discussing earlier, has been different in different Member States. The reason for the disputes is that some Member States object to applications because they feel the right things have not been taken into account. Those problems are only resolvable by expanding the scope, or at least thrashing out an agreement as to what the scope of the Directive should be. They are, if you like, a protest about the nature of the decision-making process, as much as they are about objections to an individual application. It seems to me that recourse to another set of scientific committees, without clearly the job to resolve that kind of problem, is not going to improve the situation.

Lord Gallacher

  209.  Is there any body at the European Union level, operating with similar aspirations and organisation functions to your own, which could represent the opinions you hold when matters of dispute appear simply to be about to be resolved on a yes or no basis in Brussels?

  A.  There is, and I am sure they do. There is the international organisation of Friends of the Earth which is called CEAT, which is a French acronym, which operates in Brussels for international NGOs. They do, of course, monitor the way that the scientific committees are working.

  210.  Would you say that it is fully active in this area?

  A.  It is hard to say what "fully" means. As I was saying, I feel that the problem is not just the inability to access those committees if they were doing the right kind of job. It is that they are not doing the right kind of job.

Lord Wade of Chorlton

  211.  I am still rather confused by this. Basically what you are saying, as I understand it, is that the views on these issues are very diverse. A lot of them are based on emotion rather than upon scientific fact. It is where people come from and how they see these issues, which is dramatically differently. We are aware of that. You are saying that because of this, the present system is not satisfactory. Whatever system you have, how do you actually deal with that issue, when the scientists can say, "These are the actual facts of the case and we see it from a scientific point of view"; but other groups in society can see it from an entirely different point of view. I do not quite see how you say that is a problem with the present system of decision making. How do you resolve any other system of decision making that takes those two extremes, (or may well turn to extremes)? The point I was talking to you about earlier, that clearly there is a view on the economic issue. Many groups in society put the economic needs before certain environmental needs. You said to me, in answer to that question, that this is a political decision and has to be taken from a political point of view. Are you saying then that we set up political committees, which ultimately make the decisions, yes or no, because decisions have to be taken?

  A.  Let me be clear about what I was saying about the possible inadequacy of the scientific committees in the situation of dispute between Member States on applications. The two things going on there are the nature of the scientific advice on the possible effects of each application, and whether that is accessible and accountable, and the fact that some Member States want different kinds of environmental impact taken into account. So it is not even about those broader issues you were talking about, about where the social or economic benefits are judged. It is simply a dispute about what is the interpretation of environmental harm in this context. Some Member States, notably Denmark, Austria—and Norway when there was a time when they were likely to join the European Community—when the first application for commercial consent went through, the PGS oil seed rape, there were very strong representations by those countries that part of the evaluation should be the effects of the herbicide used in conjunction with the crop. That was the root cause of the very long dispute within the Community about whether that particular crop should be allowed through. That seems to me the kind of dispute you can only resolve by talking to countries about it: is there a resolution in terms of taking those effects into account, or will they agree to drop that consideration for this particular application but have it brought in for future ones? Do you see what I mean? That particular point of contention is not something you can solve by going to another scientific committee and saying, "Is this a good thing or not?"

  212.  I accept that. What I am asking is, what decision-making process do you establish if you accept that there are different views, different priorities, in coming to the right decision? Ultimately, decisions have to be made. What I am asking you is what kind of process do you believe could make decisions and be seen to be effective and people would respect the decision?

  A.  The process should come out of the revision of the present Directive—which I think should seek to expand the scope of the Directive so that it clearly takes into account all the possible environmental effects of growing GM crops—I am not proposing that the regulatory system embraces issues of need and benefit at this stage. I personally think it is very difficult to do that. All I am asking is that it embraces all relevant environmental considerations. At the moment, there is serious dispute amongst European countries as to whether that is the case.

Lord Willoughby de Broke

  213.  Are you concerned at all, that the length of time of regulation of these matters which we have been talking about, is putting European companies to a disadvantage in relation to American companies—it is perhaps not your concern but you are aware of that—where the regulatory process seems to be much shorter?

  A.  The first comment I would make is that the regulatory process in America, in its principles, is surprisingly similar to Europe. Although people try to make them look as if they are very different, in practice I think in the way they seek to operate is very similar. The delays in Europe, as I was saying just now, have been due to the fact that Member States have not been able to agree upon how we should judge the adverse effects of some of these products. Therefore, the delays have not been endemic to the structure of the regulation. They have been a consequence of its aspiration, or rather the failure to spell out clearly what the aspiration is of the Directive; what the role is of the Directive; and how it should seek to protect the environment. It is not a failure of the fact that it has to go to each Member State, be cleared, and then sent back to the Commission or whatever. It is that in that process, people have found more and more issues which they feel they cannot deal with adequately, or that there is not agreement; or that when each Member State gets an application, they find they look at it in a very different frame. That is where the delays and disputes have arisen. So, in that sense, the resolution has to be a political one through a process of revising the Directive to a more satisfactory state, where it more clearly and adequately deals with all these environmental issues. If that can be achieved, then things will be seen to be proceeding more smoothly. It may mean that some things do not get clearance. That has to be accepted. I hope we have the capability to say no to some of these developments. In that sense, I am sure our European industry will argue that it is a disadvantage, but I am afraid our primary interest is that there should not be environmental damage and that if we have to say no, we have to say no.

Lord Jopling

  214.  I confess I am a bit confused because you made various answers in which you were very critical of the centralised system of decision-making, yet I heard you say earlier with regard to segregation that you did not think the United Kingdom could do it alone, which implied to me that you felt that there should be a centralised arrangement. That brings me to the question: do you believe that the jurisdictions are about right as they are, or do you think there is a case for giving individual Member States greater latitude to go their own way, when it comes to the question of granting commercial consents?

  A.  The issue of segregation is a difficult one. If we are talking about segregation of what are globally traded commodity crops, it implies requiring American farmers or Canadian farmers or Brazilian farmers to segregate their crops before they are bulked up and shipped to this country. That is what I meant, I am not sure that our Government can require that. I do not see what the legal basis could be for doing that, other than banning the import of anything mixed. I cannot imagine that being acceptable under trade rules as they stand. There is a strong argument for looking at trade rules and the extent to which they could be developed to allow countries to say no to particular genetically modified foodstuffs or crops if they were felt to have a human or environmental threat. That actually should be possible under trade rules, at the moment, but you have to show a very clear and immediate threat as opposed to a less clear and possible long-term threat, so there is probably room for looking at trade rules. This is what I meant about the difficulty of unilateral action on globally traded commodities. In terms of jurisdiction over environmental impacts, there ought to be a lot more room for the United Kingdom Government to act. So that the United Kingdom Government can, for instance, put conditions on the way that crops are grown or the way they are managed in this country, to protect the environment. I think we have certainly got to look at doing that if we feel there is not satisfactory resolution in Europe. Ideally, there should be resolution of these environmental issues across Europe. This is because part of the reason why we have European environmental law is because the environment does not stop at political boundaries. We perhaps tend to forget that in our geographical position, but for Continental Europe it seems a nonsense to have different environmental standards for countries who share basically the same landscape. For that reason, I think having a European Directive for environmental protection in this field is highly desirable. It is highly desirable that we get it to operate properly.

Lord Moran

  215.  As you will know, English Nature have called, with the support of the other statutory agencies, for a five-year moratorium on the growing of genetically modified crops, to allow time for the subject to be better researched and the regulatory system overhauled; possibly by increasing the remit and membership of the Advisory Committee on Releases into the Environment, in order to take a more comprehensive view on environmental effects. Do you support that call and do you think it is necessary to have this pause?

  A.  I think I am right in saying that they have only called for a moratorium on one crop, which is the PGS oil seed rape, but I cannot be absolutely confident about that. I think it would be a very good thing to have a pause. I personally voted against the commercial approval for the PGS oil seed rape in the ACRE Committee and that is a matter of public record. This is because I felt we could not be clear enough about the long-term potential of the crop to hybridise with wild relatives and what the long-term fate of the genes would be.

Lord Willoughby de Broke

  216.  Could you explain the problems which you have with current risk assessment and what differences there are between Member States. Is it wise that these risk assessments are conducted by the applicant and not by the competent authority?

  A.  The problems with risk assessment: the essential problem is the inability at present to look at indirect effects, which we have already discussed, so that the risk assessments tend to concentrate on the ecological impact of the possible movement of genes from a crop to volunteer populations of the crop, or to wild relatives. There is attraction to things like the possible impact of engineering insect resistant directly into a crop and how that may affect the surrounding environment. However, the wider knock-on effects, particularly the effects of chemical usage in conjunction with herbicide-tolerant crops, are at present left outside the risk assessments and that is a major failure. Another problem is the limitations of the case-by-case practice of risk assessment. I mentioned just now that risk assessment would look at something like an insecticide engineered directly into a plant, where the plant is expressing the toxin. A risk assessment would try to look at which insects that might affect; for instance, would there be non-target as well as target species affected? One of the problems of a case-by-case approach is trying to get a view of those effects on a cumulative and additive scale. You can maybe do it on one crop, in one particular management context, but it is very difficult to ask the question: what happens when a large range of crops, in a large range of situations, have that kind of engineered toxin? What might be the overall impacts on the insect populations? It is a question of the cumulative impacts of using that crop as part of agricultural strategy. It may well be that this is not something you can deal with in individual risk assessments, but individual risk assessments should certainly give us the clue to look at it on a much broader basis. So it is the ability to look forward and be strategic that we lack, I think. You can do an individual risk assessment in the light of what has gone before, but it is very hard to do it in the light of what will come ahead. Another problem for the risk assessment system, as we have it, is that we do not have a clear interpretation of what is harm to the environment. The Act deliberately avoids it, to avoid pinning something down to which one could then see exceptions. It is deliberately broad. The problem with that is that it has tended to be narrowly construed and we do not have a clear view of what is an acceptable impact on the environment. The example we had just now of the PGS oil seed rape, the risk assessment on that, when it was given approval for commercial use it was assumed that there would be some hybridisation with wild relatives, but the judgment was made that it would be on a scale which was not a problem. I do not think that is the kind of judgment which commands widespread acceptance at the moment. A lot of people find that prospect alarming, or would say it is unmeasurable and contains too large a degree of uncertainty, really to base a definitive judgment of risk on the kind of data we have. So that is another problem. We have contention about what is an appropriate interpretation of environmental damage from this kind of technology. Your question about what is the difference between Member States: as I mentioned earlier, one of the primary differences has tended to be the extent to which indirect effects are taken into account. There is a quite helpful document that was produced for the Science and Technology Options Assessments Panel of the European Parliament, which is called An Appraisal of the Working and Practice of Directive 90/220/EEC, on deliberate release of GMOs, by Rene von Shomberg. That sets out, in some very helpful tables, the different views and disputes between some of the Member States about the operation of the Directive. Your point about: is it a problem if the risk assessment is undertaken by the applicant? I do not think it is a problem if the competent authority which judges that risk assessment is in a position to challenge the data submitted and the conclusions drawn from it. My impression of the way the process works in this country is that the officials who prepare the applications for the ACRE Committee consideration, go through them in extremely thorough detail and check that all the relevant questions have been addressed and that the right information is there. Also, they check that the conclusions are supported by the data and that nothing has been claimed as commercial in confidence if the applicant cannot justify that. A great deal of work is done to make sure that the applications are thorough. All that correspondence goes on the Public Register so it is possible to see what kind of backwards and forwards process has been undertaken. What is more important is that we are asking the right questions and making the right judgments. As I said earlier, one of the problems is that there are large degrees of uncertainties built in, in any judgments, about the environmental impact of genetic technology. It is very important, in looking at risk assessments, that we are clear where those areas of uncertainty lie and what we are judging to be an acceptable level of uncertainty. That is what a lot of outside commentators have a problem with. There seems to be an end result that makes it look as if lack of evidence of risk is actually evidence of safety. Those are not the same things. We have to be explicit about uncertainty. This is one of my major concerns about our system of having an applicant do a risk assessment and then having that judged by the committee. Perhaps both parties know what the uncertainties are but they are not drawn out very explicitly.

Lord Grantchester

  217.  Do you want the companies to take the decision themselves on assessing these risks within the committees? Do you think the committees could actually test these risks and have a legitimate extension of the regulatory framework? Could they actually test these risks if you are then assessing them as being beyond the scope?

  A.  I am sorry, would you mind repeating the question. I did not quite catch it.

  A.  You talked a lot about risk assessment and undertaking risk assessment before things go ahead. The question is whether the company wanting to undertake any genetic experiment can actually test the risk you are assessing. You say this is an unacceptable risk. Can the company then go out and test that risk?

  A.  So can there be adequate data on whether something is dangerous or not? Is that what you are saying?

  218.  You are making a risk assessment to say that we think this is an unwise experiment or test because of X,Y or Z. I am asking you, could the company challenge your risk assessment and do the test, as to whether there will, for example, be cross-pollenisation into the wild environment?

  A.  The problem is that a lot of the issues, which are being put forward as possible risks and being judged, are ones which it is almost impossible to empirically test. To give you an example of hybridisation with wild relatives of an oil seed rape crop. Most risk assessment tends to be based on whether it has been possible to almost forcibly cross oil seed rape with possibly compatible species in laboratory conditions. To begin with, it was said that this had hardly ever been observed in the field. As time has gone on, various researchers have observed particular hybridisations in the field, and some have been quite surprised by the fact that they have been able to observe them and observe them at a greater rate than was thought possible. That is the sort of thing which is only possible when the experiments or the commercial growing is done on a very fairly large scale. This is the point about what scale of release do you sanction, in order to get that kind of data before it presents itself as an unacceptable risk? This is my point about looking at the issues after commercialisation. With some crops it would be impossible to come to any very definitive answers about how far things like cross- hybridisation are going to occur. It may well be quite proper to judge that it is unlikely that they will occur at a scale that causes us real problem. Certainly, it will not happen quickly but we should be monitoring to make sure that is the case. In a way, you have an on-going risk assessment on that kind of issue. There are other issues to which you might quite properly say we do not have enough information and, therefore, nothing should go ahead. Under that category you possibly have things like work with virus resistance, where we have very little information about the possibility of recombination of viruses, for instance. That may be the kind of work which is too risky to take to a commercial scale. It is very hard to quantify the extent to which it might be possible to create a new plant virus. I really think it differs with the crop which is under consideration and the scale at which it is being used at the time.

Chairman

  219.  You call, in your paper, for clarification on the subject of liability of damage caused by GM crops. Does your Alliance have views on that subject as to what the liability should be?

  A.  Yes. Personally, I think there should be strict and retrospective liability for damage from GMOs. We have advocated that for other forms of environmental damage. It is even more important in this field.

Lord Grantchester

  220.  How far should the risk assessment come after the experiment, which was the point I was trying to bring out in my question. Obviously there is the fact that you do not really learn a lot unless you are prepared to take risks. If you say "de-risk", companies are not really going to make great strides forward in learning. This brings me on to the question of responsibility of companies. What, in your view, are the responsibilities of companies developing genetically modified crops, and should they have a wider responsibility other than just trying to find out scientifically the effects of the experiment?

  A.  Yes, I think they should. I would say they have responsibility to consult stakeholders. For this technology there is a very wide range and very large number of stakeholders. Companies developing these crops are effectively asking the entire consuming population to eat the food that results from them. They are also asking all of us, possibly, to bear a certain degree of environmental risk. In that sense, the earlier they address those kinds of concerns and talk to interested parties about the concerns and the priorities people have, the more chance they have of developing products which do have clear benefits and do not present risks.

Lord Redesdale

  221.  There is a growing body of concern about the risks that GM food is putting forward, but most GM food is grown in the United States at the moment. Why has there been such a different reaction between European consumers and American consumers?

  A.  I do not know in detail. I do not think anyone can know really. I can make two conjectures. One is that the United States has not suffered the same crises of confidence about the handling of food risk that we have in Europe. Everyone hates the analogy with BSE but let me make it clear what the analogy is. The analogy is not one of a similar type of risk necessarily. It is an analogy about the political handling of risks that are hard to quantify. The fact that the politicians were willing to say "it is safe" when they had no basis for doing so. The fact that they were prepared to attribute responsibility for the problems to their scientific advisers, which I think is entirely unfair. In that sense there is an analogy with GMOs. Consumers are wondering, "Well, they told us it was safe last time, does this apply here? How can we be confident that the right relationship is established between the scientific advice and political judgments on that scientific advice?" So maybe the United States has not suffered quite that kind of crisis of confidence on that level. The other conjecture is that the United States has rather more natural environment left than we do. Most of the United Kingdom environment is either semi-agricultural or, in fact, fully agricultural. A lot of our remaining precious landscapes and small pockets of biodiversity are embedded in that agricultural and semi-agricultural landscape. In that sense it is possible that GMO crops could have a disproportionate effect on what is left of our biological diversity. That is not true in the United States because they very sensibly fenced off large areas of wilderness so that they are untouchable. They are, however, engineering native species to be genetically modified and I think that is a huge risk. I do not know why American consumers are not more concerned about that.

Chairman

  222.  On that provocative note I think we will have to end. Thank you very much indeed for coming to give us your evidence.

  A.  You are welcome. Thank you, my Lord Chairman.

  


 
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