WEDNESDAY 28 OCTOBER 1998

PROFESSOR PHILIP JAMES and DR ANDREW CHESSON

  636.  Can I welcome you both, Professor James and Dr Chesson, to this Committee and for coming to give us evidence on genetic modification. Thank you very much for having taken the trouble to come down from Aberdeen to help us in our inquiry. Could I perhaps start by asking you to introduce both yourselves and your Institute and say what your Institute does in this field and what your separate responsibilities are in the Institute?
  (Professor James)  Thank you. I am Professor Philip James. I am Director of the Rowett Research Institute, which is an institute predominantly funded by the Scottish Office and currently by the Department of Agriculture. This is an institute with 300 staff, but with visitors and students it goes up to about 400. We have a responsibility for essentially undertaking nutritional research throughout the food chain. We now describe it as a reverse food chain approach so that in relation to genetic modification of foods and plants we become involved because we are used to assessing industrial issues in relation to animal feed and we also have to consider increasingly the impact of agricultural developments through the food chain on human health. So we have both human studies and animal studies going together. I have other duties, of course, and I am asked to take part in UK Committees. Until recently I was a member of the Novel Foods Committee and I currently am still a member of the Committee on Medical Aspects of Food Policy of the Department of Health and am Chairman of the Nutritional Aspects of Novel Foods for COMA. I am also on the European Scientific Steering Committee, but perhaps we can come to that later. Dr Chesson is a senior member of staff with special responsibilities and perhaps he can introduce himself.
  (Dr Chesson)  I am responsible for the part of the research work in the Institute primarily concerned with events that occur in the digestive tract and the impact of foods, including novel foods and feeds on the events that occur within the digestive tract. In addition, I am a member of one of the scientific committees of the European Commission that operate out of DG XXIV, the DG that, as you will be aware, is concerned with consumer health and welfare. As a member of the Scientific Committee for Animal Nutrition (SCAN) I was seconded to a working group set up to look at all genetically modified material which is being considered for release in Europe under Directive 90/220/EEC of the European Union. I am there to look primarily at the animal feed aspects, but clearly this is only one part of what the whole working group considers.

  637.  Thank you very much. We are extremely interested in your membership of the European advisory committees and many of the questions we want to ask relate to that. It will be helpful to us to hear about these matters ahead of a visit which we are making to Brussels next week. Could I start by referring to a matter which recently brought your Institute into the news, namely a World in Action programme which presented dangers concerning lectins in a potato and were purportedly based on data that was made available by your Institute. Could you explain exactly what happened in this case and why the misunderstanding arose, if that is what it was?
  (Professor James)  Thank you for the opportunity to make a brief comment on this. We regard this as a very unfortunate development because the Institute has been involved with a whole range of different analyses of GMOs and new developments in both the feed and food business. This particular issue of lectins is the interest of one of our most renowned scientists, Dr Pusztai, who for 35 years has been doing research on lectins, a natural constituent of plants with pest resisting properties and therefore of great interest to the plant breeding industry because of the natural attributes that lectins have. He has been studying the impact of these lectins in animals and man and has identified the fact that these lectins have varying effects depending upon their detailed structure. He alerted me about three years ago to the fact that he was becoming concerned that some of the lectins that might have been used were in fact those lectins which he already knew could have an impact on the animal gut and therefore presumably on the human gut. Of course some of these lectins that have been studied are very well known to us, for example in red beans that have to be boiled. You are boiling them before you eat them simply to destroy this lectin which otherwise has a major impact on the intestine. His concern was that with the joys of being able to identify a particular molecule with pesticide properties there is a tendency to say, "Ah, it will destroy the insect gut, let's put it into a plant". That could be done without considering what the potential impact might be on other animals and indeed on man. As a result of this concern, which was published and which he has been discussing in scientific meetings over many years, I took the concern to the Novel Foods Committee in Britain when we were considering one of the plants being manipulated with a new insecticide insert. As a result of looking at the process whereby we assess novel foods we came to the conclusion that we needed an additional track so that we would have an early alert on the broader impact of some of these lectins. Therefore, the UK system for assessing novel foods already has that additional safeguard incorporated into the process as a result of Pusztai's concern. We also arranged for that to be in the European system. What happened with World in Action was that they heard of two or three of our programmes, one of which was funded by the Ministry of Agriculture, the other a special extra programme by the Scottish Office. This one that was referred to was asking the question, "If you do use different lectins and transfer them as a GMO into a plant, should we be developing new tests to try to assess other impacts that these lectins might have as an additional safeguard which could be put into the regulatory assessment process?" Dr Pusztai had been concerned to get this right and as a result of the World in Action team going to see him I had a discussion with him and believed that his concerns were legitimate. We therefore had an agreement that he could take part (because this is a publicly funded research programme done collaboratively). I also felt it was important to show that we were operating in the public as well as industrial and other interests, and that we were doing work on this topic. We agreed, however, that we should not release any unpublished data. In the event, as a result of the intensity of the interviewing, and despite all the attempts that we made to distinguish between unpublished data and published theories, unpublished data were presented in such a way as to give grounds for great concern in that they implied that there were very substantive adverse effects from genetic manipulation which we would have to assess. There was a bit of a muddle as to what experiments had been done so I immediately at that stage, having been led to understand that particular experiments were being discussed freely in the media, tried to put a stop to any release of unpublished data beyond the minimum. The plants used and these particular studies did not have anything to do with their putative release into the food chain. They were purely a theoretical construct where we are trying to look at how to go about testing the concepts, i.e. could we think of new ways of looking at this problem? So it was not a practical issue: it was a theoretical background piece of research. When it became clear that we were having to answer the question, with all the intense media interest in what exactly was done, I immediately invoked a system which I was familiar with in the Medical Research Council. In other words I suddenly had to say, "Hang on, there is confusion here. We must not allow confusion to occur in something of such enormous public interest. Therefore, please, Dr Pusztai, stand aside. I will appoint people with great authority and independent of me or the Scottish Office or anybody else to assess all the data that seemed to have been talked about." I appointed Dr Chesson, because of his background in GMOs and so on, and three other individuals, two of whom were from outside the Institute. They conducted an independent report and we are happy to provide that to you today. In summary, after they had looked at the data made available to them, they concluded that for the present there were no grounds for concern on the basis of the studies that they had looked at. The immune studies, which made such an impact in the news, were very preliminary studies which were added as an extra to the original study which was an attempt to see whether there were anti-nutritional effects and impacts on digestibility and growth and so on. Therefore, from our point of view, we are happy to clarify the issues. There is no question of any malpractice. Of course, we did not expect that remotely with a man, Dr. Pusztai, of such prestige and known to be so scientifically rigorous. We confirmed that a series of experiments had been done and at present we believe that this background research should be published in a proper way—it should be evaluated by experts. That does not lead us at present—future research may—to the view that there is a need for major change in the way in which we assess GMOs. This is public research done in the public domain. We may in due course, as a result of new data, come to different conclusions, but I thought it important, particularly since we were coming today, to make these analyses available to your Committee and indeed to the world at large. We are doing that in two tranches: first, giving an overview but then reserving for expert people who wish to examine the data the details so that we do not prejudice, formally speaking, the proper publication and evaluation of the detailed experiments. I hope that that will be seen to be the proper way of conducting the process, my Lord Chairman.

  638.  I understand that a formal audit of Dr Pusztai's findings has been carried out by an expert panel containing representatives from outwith the Rowett Institute and that a copy of their report has been sent to the Scottish Office. Is the report that you very kindly said that you would be giving to us that audit?
  (Professor James)  Correct, it is precisely so. I should say that this report—and Dr Chesson would be happy, I am sure, to talk about it—did of course properly go to the Scottish Office. It also went to the collaborating institutions who are not directly involved in the particular experiments that were being conducted on the nutritional and immunological reactions. What we are producing today has been seen by the Scottish Office and it has been seen and agreed by the collaborators. I have also now presented it to Dr Pusztai. I received on Friday evening some new data and new analyses from Dr Pusztai and they are going to the Scottish Office and to the members of the audit committee. His report has new data and further interpretations and that is part of the normal scientific process. So what we are releasing today is the audit report and a general overview that I hope the public can understand. We are then going to look in more detail at this new information that comes from Dr Pusztai and if there is a need to make a public state thereafter we will do so, but we would like to seal off the audit issue because the water got very muddied as to whether there was interference or misconstruction of the data. It is very clear that there were experiments undertaken and Dr Chesson can talk to that if you so wish.

  639.  In your Annual Report for 1997, in relation to one of your research items, it was said that "a significant finding is that plasma DNA can persist for appreciable periods in human saliva." Can you tell us what the results of the research which has now been completed are and what the implications of its findings are for eating genetically modified foods?
  (Professor James)  I could. I think Dr Chesson might answer it with greater specificity.
  (Dr Chesson)  We have a series of experiments on-going at the moment looking at the survival of DNA in the digestive tract because I think the assumption until fairly recently has been that DNA is very rapidly degraded and therefore poses no problems. In some preliminary work we did we found that isolated DNA from plant material would survive for periods of up to 20 minutes in the mouth, the implication being that this would allow time for uptake by the micro-organisms which exist within the mouth. The periods of survival are far less when the DNA moves further down the digestive tract to the point that when we enter the stomach we are talking about a few seconds. The interesting thing is that this work has not been taking place in isolation. There have been a number of studies which have shown that DNA does survive to a remarkable extent in the digestive tract and not only that, it is actually taken up by the host cells and you can detect it systemically in the body. We have to assume that DNA, which in some way enters the digestive tract either through food or micro-organisms, has always been taken up by the human body, but there is very little evidence that that DNA has been incorporated. We have had to re-think considerably our thoughts on the survival of DNA, and the assumption that it is automatically degraded and therefore not taken up by human tissue is palpably false, but there is no evidence to suggest that this is anything other than a perfectly natural event which has been occurring throughout human history.

  640.  You do not think it has any implications therefore?
  (Professor James)  There is no evidence that suggests otherwise at this point in time. On the other hand I do not think we can make blasé conclusions about the poor survival of DNA any more.

  641.  Could I just ask another question about a piece of research that I think you were involved in and that is the MAFF commissioned work on the potential for gene transfer between manipulated bacteria and resident micro-flora of the human gut. I understand this is now complete and I wondered what it was demonstrating and when we were going to see publication?
  (Dr Chesson)  That work is actually still on-going in a series of MAFF grants and there are a number of publications which have already come out from that looking at particular resistance genes and their survival. In the first part of that work the work was done in the context of the ruminant animal and the rumen and looked at their resistance to a very common antibiotic, tetracycline. Yes, we do have evidence of gene transfer between organisms.

  642.  And can you indicate overall the successive stages of these studies even though they are not yet published?
  (Dr Chesson)  Some of them have been published. Some of the work is still on-going.
  (Professor James)  Could I just come in and say that this is Dr Harry Flint's work and this is part of an on-going programme where it is becoming very clear that if one looks at the bacteria in the intestine, in fact there is far more plasticity than some might imagine. It is only by using new molecular techniques, which we have established within the Institute, that you are able to demonstrate the specificity of flow of particular components of DNA between different organisms. So what we first dealt with was the capacity of a plant piece of DNA to get into an organism. The other issue is whether you can become antibiotic resistant, for example, and will that resistance transfer. The evidence is that there is substantive transfer between different groups of organisms.
  (Dr Chesson)  The evidence is certainly that that transfer is possible and it almost certainly occurs on a regular basis. Having said that, you would then have to put that into context, of course, whether that transfer has any significance at all.

  643.  Are you prepared to say whether you find that of concern or not?
  (Dr Chesson)  I find it of limited concern where there is very extensive inherent resistance to a particular antibiotic. A number of the antibiotics that are used as selection markers in the production of genetically manipulated plants for instance make use of antibiotics to which there is very extensive resistance already in the organisms of the human gut, notably neomycin resistance where perhaps 20 or 30 per cent of the organisms carry that resistance. I believe that the transfer of resistance is a fairly common event. It is questionable whether the 1,000 or the 2,000 or the 3,000 events that may occur at any point of time in the gut has any significance against the millions and billions of organisms that are already resistant to that antibiotic.
  (Professor James)  Could I come in on that in terms of general questions because your concern is about the broader implications and Andy Chesson has brought up the question of antibiotic resistance. This is of great concern both in the UK and indeed in Europe. In the Scientific Steering Committee we established a new group to look at antibiotic resistance right across the animal kingdom and indeed the plant kingdom because in the Animal Nutrition Committee with which Andy Chesson is involved they are concerned with what should be in the animal feed. Then the question is what are the veterinarians doing with antibiotics and what are clinicians doing with them. That is why we are so concerned to get a grip on this problem. So there are many different dimensions to the story and the free flow of DNA between particular bacterial groups needs to be taken into that analysis. So we recognise that things are not rigid compartments. That is why it is to important to look in an integrated way at the food chain.

  644.  Professor, two questions. First of all, I understand that Dr Pusztai was suspended. Could you say what his status is now with the Rowett and whether he has a future in the Rowett? The second point is that I have a note from Friends of the Earth who say that a certain amount of confusion has arisen because on one occasion you said directly to the media, and I do not have the reference of when, that the potato experiments did not use GM potatoes, whilst I understand a press release which was put out stated that experimental studies were on "GNA transgenic potatoes". I wonder if you could explain this confusion.
  (Professor James)  I apologise for that confusion. It was that confusion that we found so embarrassing because we were led to believe that in fact the studies that were of great importance, and that were being talked about in the media, much to my horror, before the television programme transmission, related to transgenic potatoes containing one of the lectins, Con A. What we discovered, and this is confirmed by the Audit Committee report, was that although the Con A transgenic potatoes had actually been produced (and we were just at the point where the nutritional evaluations have been done and the adjustments made ready for feeding studies) the feeding studies not been conducted with that particular lectin. We then, as a result of the audit, confirmed that a full set of experiments were just nearing completion on the snowdrop lectin GNA. So it is true, the transgenic potato studies were done with GNAs. It is also true that they were not done with the other lectin, the Con A, which was the subject of such intense media pressure on the first day. It was that first Con A problem that led to all the confusion and the statements that things were happening with transgenic Con A potatoes when in practice they could not have been happening because the Con A transgenic potatoes had not been fed. As to Dr Pusztai's status, I think it is terribly important that you understand that under the rules of the proper audit process we made no judgments as to what Dr Pusztai had or had not done. We then saw the transcript of the television programme where there was evidence that for a variety of reasons he had implied or stated things that were essentially unpublished. I regret that that emerged, contrary to what we had expected in the media. Dr Pusztai is a very distinguished 68-year old academic within this Institute. He was suspended. He is no longer suspended because the audit is complete. He is engaged in a series of major European, industrial and Scottish Office studies, most of which are either coming to an end or going into a new phase of development. We have decided, because of the muddle, as I put it, that occurred with Dr Pusztai's work that these data and the set of studies be published in the normal proper way. This will involve Dr Pusztai in the normal way. When it came to the renewal of his contract at the end of December of this year—we have been doing that for eight years on an annual basis—we had to face the challenge that if we had to have an audit on this piece of work, how could we know that in another new study we will not suddenly have demanded of us, particularly if it is controversial work, a further audit? So I came to the conclusion that he should not be the prime investigator in future studies but that if different groups within the Institute sought to use him as a consultant then that was entirely proper. So Dr Pusztai has come out of this audit review exonerated and to be seen as we all knew him as an intense investigative scientist with an international reputation. There was a muddle in what was being said in that first 24 hours which I regret. We have now clarified the issue and the detail of what in fact will emerge from all these studies will be put through the proper process of evaluation by peer review and I will be discussing with Dr Pusztai his latest data. There is no way in which as a Director I will suppress, manipulate or manoeuvre anything in relation to these studies. It is important that what is produced experimentally is published and put into the public domain.

Chairman:  Thank you very much, Professor James. We will read the audit with interest. I think we ought to try and press on now.

  645.  Professor James, in this inquiry we have encountered many more risks in relation to the environment than to human health. What is your opinion on the safety and risk of genetically modified foods?
  (Professor James)  My Lord, that is a very general question. I am very familiar on a European basis with the increasing concern about the general environmental issues. What we have been concerned with predominantly in our Institute is the animal and human impact. I think there is much more emphasis on the environmental, but I think it might be helpful if Dr Chesson gave you an indication of the categories of safety that have to be considered with GM foods because I think it is very difficult to get a generic yes or no response to that particular question.
  (Dr Chesson)  I think I would agree with that. I think there is a tendency to use GM plants, GM foods as a catchall phrase. It is very evident that when you actually look at each of these individual genetically modified plants you really have to consider them on an individual basis from the viewpoint of safety aspects because each is quite different, each contains different populations of introduced genes, each has different characteristics, each has different potential uses and potential dangers for the environment and for human and animal health. I think looking at the 11 or so genetically modified crops which my working group has actually agreed are safe for release in Europe, then I think probably the greatest debate was about the potential effects on the environment and the horizontal transfer of genes, particularly herbicide resistants into other crops and particularly those involving oil seed rape. I think this is going to change in the future. If you look at the sorts of products which are currently undergoing trials and the sorts of products which are being considered at a laboratory level, I think we are going to see some quite novel constructs which are going to ask and raise a whole series of quite novel questions and certainly questions which have not been raised to date. So I think it is very difficult on a generic basis to comment on the safety of GM foods. I think you can only really do so on a case by case basis. Perhaps you would allow me one minute just to exemplify this. One of the crops which has recently been considered for release is the genetically modified tomato, the products of which have been in the market in the UK for the last two or three years. This genetically modified tomato is genetically modified by introducing exactly the same gene that the tomato already produces, it is almost identical. It seems to me that the risks posed by that as a piece of genetic engineering are relatively small compared to the risks introduced by, say, one of the lectin genes that have been considered previously, which opens up a lot of other questions. Curiously enough, there is one lectin gene which is already used in European agriculture and that is the Btk toxin, the toxin which is used to confer insect resistance, but the Btk toxin is unique. It is the only isolated toxin we have used for 35 years as an insecticide. It has already been added to plants which have entered the human food chain. So unlike other lectins, we have a considerable amount of historical support for the suggestion that that gene product is inherently safe within the human food chain. You cannot say the same about novel lectins for which we do not have the same body of historical evidence. So I think the whole point of risk assessment is that it does have to be on a case by case basis and you really cannot make any generic conclusions about the safety of GM crops as a whole.

  646.  What is your view of the current EC assessment process for novel foods and its implementation in the UK?
  (Professor James)  I was involved originally in the Scientific Committee for Food and the sub-committee that was involved in developing the proposals for novel foods regulations. I am not now on the Novel Food Committee in the UK, nor indeed now on the E.U. Scientific Committee for Food so I may be slightly out of touch with the precise state of affairs, but there is quite a complex process involved. I think that there has been an attempt to speed the process by which novel foods can be assessed such that there are time limits put on, first of all, a national assessment that then goes into Europe for distribution to other national groups who have to make a response. This is quite a complex process. I believe—I could easily be wrong—that that has not yet been tested properly. Certainly I am Chairman of the nutritional group of COMA, i.e. the Committee on Medical Aspects of Food Policy, and we have had to generate an extensive list of consultant colleagues so that we can turn round a view, should we be asked for it, very rapidly. In the old days we came together and looked at it very carefully. Now we have to respond after 60 or 90 days—I always forget what the time limit is in this process. That is a scheme which may have to change, but I think it will have to change on the basis of experience. At the moment there is an attempt being made to have an open process that allows every country to make a response and allows every expert group to look at it, but the speed is such that many national committees are worried as to how they are going to cope. I think it is fair to say that.

  647.  Do you think the assessment of genes which do not have proven track records for food use is adequate at the moment? Is further research needed in any area, for example in allergenicity?
  (Professor James)  Dr Chesson and I were discussing that a couple of days ago and he may wish to comment on this. I think that is a very difficult topic to assess, how do you know what level of "allergenicity" we normally have with a range of foods? There is a big dispute about that. If one is going to introduce a particular protein genetically one can look at the structure of the protein and ask if we know that this type of structure causes allergies. But if you say the structure may be slightly modified in this particular plant, how on earth are we going to assess whether that is going to induce in a very small subsection of the population an unknown allergenic response? I am not sure how we are going to cope with that yet. Perhaps I can just call on Andy Chesson to put me right if I have misled the Committee on that.
  (Dr Chesson)  I think I agree, allergenicity is a particular example of some of the issues that are facing regulatory bodies. As Professor James said, the standard technique at the moment is to compare the structure of the unknown protein with that of known allergens. There is an assumption which may not be warranted, which is that if there is no strong similarity then it is probable that that protein is not allergenic. That is not always done in isolation because there are also toxicity studies that are made on all of these plant materials when one might expect these sorts of problems to be visible.

  648.  This is a subject I suspect near to your heart, Professor James, the whole business of trust in food safety and measures needed to try and improve that trust. Do you think the Food Standards Agency is going to do that in the area of GM foods?
  (Professor James)  When I proposed the formation of the Food Standards Agency and its structure, which seem to be accepted by the Government, it seemed to me that this business of trust is one of the most difficult ones to achieve. It was because of the complete lack of trust in the current process at the time that I proposed that there should be a very new process in British assessment procedures. We needed to open the debate not only to the technical experts but also to have consumer representatives involved and have everything done in a very open way. That seems to have been accepted essentially by pretty well everybody. Last week I was in Paris discussing with the French, the Dutch, the Danes and United States groups exactly this issue and we all came to the same conclusion. If you are going to establish trust in the public mind it is quite difficult because everybody will complain that the media gets it wrong, but I think you have to have a mechanism in play where you need consumer representatives, however they are chosen, actually challenging and being involved in a major way. These individuals, who themselves have the trust of consumer organisations, come to recognise or challenge and change the assessment processes so that you begin to build confidence that nobody is playing games with the process of assessment. That is what I believe should be developed in the United Kingdom. If it does not come I think we are going to run into trouble. I think we have to get away from our, may I say, traditional British view that I am the expert and you do not know anything about the problem so why do you not listen to what I say? Furthermore why should you bother to question me because I am sure I am right. That is a crazy way of doing it. On the Novel Foods Committee, we had consumer representatives and Professor Burke, who was the Chairman, and I had, as well as others, come to the view that the consumer representative was enormously valuable because she made us realise that our judgments were being put in a context which just would not be understood by somebody who had a legitimate concern. So we changed our assessment process and the way in which we reported it. After the Food Standards Agency report which I produced at the time of the election I was then asked by President Santer's office in Europe to go and talk to them about the same problem. We are currently in the Scientific Steering Committee, the Chairman and myself and two others, trying to put together a new view of how we should begin to build European trust in a new way and considering specifically the GMOs as well as other risks. At the moment there is a European Parliament in one corner, the Commission in another and then there are national governments in another corner with Ministers. There is a disjunction and a failure to interact with the public. I think we need a new mechanism on a European basis and that is something that we agreed on Friday last in the Scientific Steering Committee that we would begin to look at. I do not have the answers. I think we have got to explore this. I am quite sure we are going to have to keep changing the system until the public, the European Parliament and this Parliament are convinced that we are beginning to engage the public, the industry, the scientists and the technocrats in an appropriate way. I do not think we have got it right at the moment.

  649.  Is there anywhere that has got it right that we could learn from? There does not seem to be quite the same degree of distrust in the United States. Is that by chance or is the process better there?
  (Professor James)  In the United States, following our report, they have been re-evaluating what they are doing. There are now proposals for the USDA dealing with the agricultural animal side of food safety, to come closer to the FDA. They have a much more open public assessment system in the United States. There is a much greater freedom of information. There are objections to committees meeting in public, I understand, but they have very public discussions. When you talk, as we did last week, with the US experts, they just assume that experts have to justify their every opinion to anybody who comes along. I do not think that we have that determination in our culture and I think that that in part is why in the United States you have less of a frenzy, compared with our going into a great spiral on one of these GMO issues.

  650.  What are your thoughts on the potential delay in setting up the Food Standards Agency?
  (Professor James)  I recognised before the Election, talking to the Independent Constitution Unit, that the potentially incoming Labour government had a huge legislative load and so my original proposals pre-supposed that the Food Standards Agency would be going through in the next session of Parliament. I therefore proposed, because I knew the question of trust was important, an intermediate solution where you had, if you like, a shadow commission for this agency. That was deemed to be "unconstitutional" in that it presupposed, despite my having checked it with the Constitution Unit and with Cabinet Office officials, that Parliament would agree that a Food Standards Agency should be appointed. If a Food Standards Bill does not go through this next session of Parliament then there is a real danger, with all the heat, debate and concern about GMOs, about BSE and about at least a dozen big issues—that we are going to delay the building of trust in our food system. So I think that some mechanism may need to be devised whereby the public interest is brought in now and in a more overt way. How that should be done I think is a matter for debate.

  651.  Is that something along the lines of the Stakeholders' Forum which the Government announced they were considering last week? Would that fit the bill from your point of view?
  (Professor James)  Yes. I do not know the details of that, but I think we need a process which effectively begins to allow the challenge and debates to be operating in a much more public way. That is not going to solve the problem because quite clearly everything that I have learned since I produced my report amplifies the need to have a coherent integrated approach to the assessment and safety checking process. I think that throughout the world other governments and other organisations are coming to the same conclusion. So I do not think it is a novel idea at all. I think it is now considered to be routine and the question is how to do it properly.

  652.  On that very point, Professor James, Ministers came to this Committee last week. After having read the transcript of what Mr Rooker said on the matter of the FSA, it is clear that they are not going to have a Bill for primary legislation in the coming session because it is very clear that they are going to produce a draft Bill and spend the next year doing a form of consultation, which is the new Parliamentary process which the Procedure Committee in the other House have devised, and therefore we shall not get the legislation until the session beginning a year from now and it will take probably most of the year to go through, which means it will not be on the Statute Book for another two years, so that means three and a half years from the Election. Would you just point out some of the dangers you think there are in addition to what you have said already as a result of this very long delay?
  (Professor James)  In my original report I believed that it would take between three and five years from the establishment of the Food Standards Agency to get to the point where one would build trust and begin to see the impact of new developments associated with that Agency.

  653.  If I might interrupt you, if you say it is three to five years after it is set up, that is 6.5 to 8.5 years from the first suggestion.
  (Professor James)  That would be my concern, my Lord. The issue is what could currently be done to begin to anticipate the Agency and how is one going to begin to engage the public and all the stakeholders. I believe there is cross-party agreement on the general structure of this Food Standards Agency. I think that we now need to legitimately address how some of these issues could be developed and I would have thought a provisional Commission would be a sensible approach. I stand corrected if this is unconstitutional.

Chairman:  We now come to questions to do with the EC advisory committees.

  654.  Professor, the proposed revision of Directive 90/220 will introduce the consultation of the European Community's scientific advisory committees when there is a dispute between Member States. This Committee is going to Brussels next week to talk about this whole area and I think we shall go with a feeling that there is a certain muddle in the way that these committees are appointed. I would like you to tell us how you see the structure of the committees, how you see the membership of the committees. Are they balanced with regard to scientific expertise or between representations of Member States? What do you think needs to be done to improve what to some of us seems a real muddle, to use the word you used earlier on in the hearing, over this situation?
  (Professor James)  I think that I should respond by saying that I found myself suddenly appointed to the Scientific Steering Committee as one of eight independents from Europe and therefore was promptly involved in the appointment process. It was interesting that the Commission asked us to go at break neck speed. We find that the Commission want to involve us usually at one to two or three weeks notice, whereas, like you, we are booked normally a year ahead with commitments. In those appointment groups I discovered that in fact the Commission had put out a call for other groups to propose particular individuals to be considered for an expert committee. I found myself in an expert committee where I personally had no expertise but where I was operating as the Chairman. The process was one where different Commission officials with experience across the range, including, for example, DG V from Luxembourg on public health, DG III on industry, DG VI on agriculture and so on, all had representatives and we looked at the portfolio of scientists. There might have been 150 portfolios to look at in this one area. My particular area was cosmetics. We looked at these portfolios and we were asked to produce the best experts without having regard to nationality, on the basis of their experience, range of involvement, scientific expertise and so on. We were asked to produce, if I remember correctly, about 30 experts and they would choose 15 to 25. It was made clear that they would choose 15 to 25 from our group taking account of geographical distribution. After we had chosen our 30 we then met in quorum because each of the eight of us on the Scientific Steering Committee had actually chosen with officials 30 or so experts for each committee. We then discovered there was an overlap of experts on different committees. We had to resolve their problems and we were then told that the Commission would have to make the final decision taking account of geographical expertise. I think it is not breaking confidences if I say that one of the messages that came through powerfully to every one of us—I was the only UK person amongst these eight—was that they always had a huge number of British experts who came up at the top of the pecking order on the basis of international analysis. The plea was made that if possible we should not have more than five UK people out of the top ten because if they produced a scientific committee that was stuffed with the British in every particular committee it would be seen by the European Parliament and the public as unbalanced. Therefore, we chose, taking account of expertise, about four or five British to put in our top 20 and therefore there was an element of geographical pressure, but we had started off on the basis just of scientific expertise. Does that help?

  655.  I wonder if you could answer the last part of my question which was how you feel the whole system could be improved and particularly the interlocking of the various committees. I think there is also an argument that there is a muddle there too.
  (Professor James)  Thank you. I should have addressed that. That is one of our principal concerns on the Scientific Steering Committee. Several of us are involved each time in wondering about the interplay. You have just heard about Dr Chesson's secondment from the Animal Nutrition Committee to the GMO Working Party. That was what we perceived to be important. When GMOs came up it was the steering committee that looked at this and said, "You cannot just deal with this in narrow constructs, we are dealing with a broader set of issues." Therefore, we finally agreed to have a working group working predominantly with the plant committee on plant GMOs because that is where most of the work was coming through, but we then inserted membership from other committees. We are still not convinced on the Scientific Steering Committee that we have got it right. We are not criticising the GMO Committee, but there are very broad issues of enormous public concern and one of the big issues for the Scientific Steering Committee is to try to tackle precisely your concern, i.e. how are we going to ensure that we do not have a narrow focused yes or no answer to a very specific question from the Commission about a GMO and whether or not we agree that this or this construct is or is not safe on the grounds of X only. How do we get the proposed genetic manipulation into proper perspective? It is this sort of issue that we are concerned with and we are on the point of trying to think through the problem. You must also know that there is a discussion about the re-organisation of the European Commission as a whole and the question is, on the basis of our year or so's experience, can we do things better. I would not like to give an instant answer but I think you have to understand that we have been in an amazingly rapidly evolving process where, when I walked in last September, a year ago, there were practically no staff in DG XXIV. It was incredible. I wrote all the papers on BSE for those committees, and Dr Chesson operates similarly. We will come later to the question of the time involved, but the substructure, the organisation, is only now being put into place, so you can run rings around them in terms of the proper process and how it should be done. I think they are improving. DG XXIV are very conscious that they have to get it right and they distance us from a lot of pressure that comes in from other directorates general, but I would not for a minute say that the process compares with, dare I say, the efficiency with which the secretariat administrators and scientific people within the British Government service their committees here. The contrast is really quite startling, not because you do not have very talented people in Brussels but they are absolutely frantic trying to cope with a highly complex interplay of nations and special interests.

  656.  I wanted to follow up Lord Jopling's question by asking about the operation. You have already said something about this and I wondered if you could tell us more about how, in fact, committees operate, whether you think they are well organised, whether they meet frequently and, in your view, frequently enough, and how much of your time they take up? You have told us you have to write the reports. It sounds as though it is a very considerable commitment?
  (Professor James)  I would be happy to answer that. Perhaps I should let Dr Chesson come in first, because I never see him at the Institute any more and I believe that he spends all his time in Brussels which he denies!
  (Dr Chesson)  I will make a specific answer to your question but I would like to emphasise one thing that Professor James said before I answer your question, and that is to make the point that these committees are very much in a process of transition. Up to a year ago, or just over a year ago, all of them operated out of completely different DGs and to a completely different remit. One of their major concerns was actually assessing efficacy of products, for instance, which is no longer a concern of these committees. So the way in which the committees operate has undergone a radical change and is changing even now as we talk. We are evolving the way in which we operate. The relationship to the other DGs is quite important because a lot of the DGs are still trying to operate on a historical basis, are trying to demand answers to questions which are no longer really the remit of the committees, the scientific committees operating out of DG XXIV. The primary remit of the committees operating out of DG XXIV is in terms of safety assessment, risk assessment. The time commitment is actually quite demanding. It depends very much on the nature of the scientific committees. Some have a very heavy workload, an extremely heavy workload. The Scientific Committee for Animal Nutrition is probably one of the heaviest. It will meet in plenary session virtually monthly, at least ten to eleven times a year for a two-day session, but, like any organisation, the majority of its work is actually done in small working groups. Those working groups may have a lifespan of a few months dealing with a fairly tightly defined question or they may have a lifespan which is likely to be considerably longer than my own. In the case of genetically modified plants, for instance, one cannot see that working group ending its activities for many years to come because these questions are not going to go away. So there would be at least as much time spent in Brussels in working groups, so I think you are talking of something in the region of four days minimum a month for anyone concerned with one of the more active scientific committees and that, of course, excludes the work that needs to be done in preparation for those committees.
  (Professor James)  And that is enormous. When Dr Chesson took over his work on animal nutrition, a previous expert from the United Kingdom actually used a lorry to transfer the Committee documents to his office. I personally, on the Scientific Steering Committee, have been heavily involved in BSE and was responsible for producing the BSE analysis of how we should look at BSE on a European. Therefore, I am now on a BSE ad-hoc group and on two of their sub-groups and two other sub-groups of the Scientific Steering Committee. I reckon that we are very unusual in Britain in that the British are seen as totally independent experts and it is seen that we produce our own reports miraculously out of thin air. On Friday we discovered that several British experts have resigned from sub-committees because they cannot cope with the demands of the workload. Colleagues on my same Scientific Steering Committee have ten people supporting them, paid by national governments, to integrate and sift and generate the background information. I am trying to find a means of supporting Dr Chesson more effectively. I am very fortunate in that I have at the moment one person, for whom I am trying to get funds, to help me. Without her I could not have helped with the Bone Report that was passed last Friday on BSE or the Sheep BSE Report which I helped to develop last month and so on. The original BSE report to deal with the US/European trade war threat I produced over two weekends, curiously enough with my wife working flat out with me to get it through by three o'clock in the morning on the Monday morning deadline. That is the "ad-hocry" that is being demanded of us. I have done an analysis of the amount of support in Europe compared with the United Kingdom and have checked with several other governments, and I calculate that the committees in Europe are supported by between a tenth and a quarter of the staff that we have in any major national government committees in Europe. If you have an expert committee here you may have one or two experts and administrators and secretaries. But the poor officials in Brussels operate as a single expert across three committees as well as ad-hoc sub-committees, and only now is he acquiring a secretary. It is a nightmare problem. The Brussels staff are working 12-15 hours a day and they work remarkably well. But the structure of organisation for the long term future of Europe is in my judgment inappropriate: I am in the process of telling the European Parliament just that.

  657.  I was just wondering, fundamentally what do you think needs to be done to make it more sensible and effective?
  (Professor James)  There needs to be a very substantial increase in the secretariat with scientific competence enhanced with administrative back-up. I think it should not be required that we produce chapter and verse on every document that is produced, often with demands that we produce it for public release with, quite often, every decision involving hundreds of millions of dollars in trade. We are expected to produce that at a day's notice and approve it in a session with ten other items on the agenda. That can only be done if you have got UK experts with proper back-up here in the United Kingdom. It needs to be specifically recognised that these experts do play a role for Britain by acting independently in the European context so that the European system is developed in a coherent way and so that we begin to get a proper interaction and national interflow of discussion. The alternative is to go back to a subsidiarity process where the United Kingdom does everything. The danger of that, particularly as Europe expands, is that you presuppose that another country can do things as effectively as the United Kingdom and my judgment is that it would be unwise to go down the subsidiarity route because there will be a political necessity to spread the load around the countries. I think we would be better off to have as effective representation in Europe by British experts as we can with an effective European system and the capacity to monitor from a United Kingdom base what Europe does.

  658.  How do you rate the quality of the advice that these committees give? Does the Commission tend to accept your advice? Is consulting these committees the best way of resolving inter-Member State disputes?
  (Professor James)  I am biased in response to your first point. If we have actually chosen supposedly the best experts in Europe to go on to those committees then you would expect that the advice is good. The advice is pretty good. Dr Chesson thinks so too. I believe that the pressure of the last year has been too intense to get really very well balanced, beautiful judgments that are explicit and clear in all aspects. I think that is where secretariats and so on could help. I have forgotten the second question.

  659.  Does the Commission accept your advice?
  (Professor James)  The Commission accepts our advice in the sense that you can see DG XXIV takes our advice as independent and certainly our steering committee, and I think the GMO committee have very substantial impact. But do not forget that there is a Standing Committee of governmental officials who essentially are negotiating with the Commission on the basis of our advice. It is quite a complex process. We are independent. We quite often have no knowledge of what goes on in those Standing Committees. We are suddenly asked questions by the Commission and we have to have it explained to us why we are getting that question. Quite often the question has emerged from a battle between one national delegate and another not in our view on a scientific basis at all but as part of, dare I say, political manoeuvre and trade-offs of different views. To answer your third point, the Commission then promptly comes back to us because they want to be seen, if at all possible, to be independently operating for the benefit of Europe. They, curiously enough now, are seeing DG XXIV as having the independent group that at long last, thank goodness, is giving the Commission advice as they struggle to try to make sense of the battles in the standing committees. I hope that is clear.