Select Committee on European Communities Minutes of Evidence


Examination of witnesses (Questions 673 - 699)

WEDNESDAY 4 NOVEMBER 1998

PROFESSOR JANET BAINBRIDGE

  Chairman:  Good morning, Professor Bainbridge. Welcome to Sub-Committee D which, as you know, is conducting an inquiry into the EC regulation of genetic modification in agriculture and you are our last witness. We are very grateful to you for coming to help us and give us the benefit of your expert opinion and experience.

Lord Jopling

  673.  Professor, I wonder if you would explain how your Committee considers applications to market a GM food under the terms of the Novel Foods Regulation and whether in particular you assess every GM food or only those which are substantially different from those which have already had an approval?
  (Professor Bainbridge)  Certainly, my Lords. This question is actually the crux of the work that we do in the Committee so, with your permission, I will answer the question in some detail. Please interrupt if I am talking too much. Quite clearly all novel foods are assessed in accordance with the Commission guidelines which accompany novel food regulation. These guidelines follow a very detailed decision tree approach and are very much modelled on the guidelines that were developed way back in 1994 by the Advisory Committee which I chair. I do have a hard copy that I can leave for your Lordships of the 1994 annual report which has copy within it of that decision tree. I have to say at this stage that I have only taken over the chairmanship of the Committee some 15 months ago and have to acknowledge a tremendous debt of gratitude to my predecessor, Professor Derek Burke, who was very much involved in the work which led to the publication of those guidelines. Those guidelines were developed after a great deal of public consultation which took on board consumer groups and a whole range of consultation activities. For genetically modified foods the safety assessment, as your Lordships know, is based on substantial equivalence. That really means that we recognise that traditional food safety assessment techniques which tend to be based very much on toxicological data may not necessarily be applicable in the case of foods that are produced by biotechnology. This problem was highlighted by the FAO and the WHO way back in 1990 and they held a consultation and identified the so-called comparative principle whereby foods assessed are compared with another that has an accepted level of safety. In 1991 the OECD expanded on that principle and formulated the idea of substantial equivalence which is very much part of our every day language today and a concept that we use very much. The concept of substantial equivalence codifies the idea that if a food or ingredient under consideration can be shown to be essentially equivalent in composition to an existing food or food ingredient then it can be assumed that the new food is safe. In other words, as I say, we are comparing directly a GM food with a conventional equivalent. The concept has been refined over the years since 1991. There was a major European conference in 1996 in Rome. The report of that conference quite clearly identified substantial equivalence as being established by a demonstration of the characteristics assessed for the GM organism or a specific food product derived therefrom (and I think that is very important) being equivalent to the same characteristics in the conventional comparator. The levels and variation for characteristics in a GM organism must obviously be within the natural range of variation (because there always is a range within natural organisms) for those characteristics which are being considered and based on appropriate and accurate and true analysis of the data. To move on somewhat, we are now working under the new European Regulation 258/97 and, under that food regulation, for applications submitted by the UK to the competent authority (or any other competent authority within Europe) the competent authority has 90 days to provide the initial safety assessment. This assessment obviously includes that the food is safe for consumption. It may conclude that more data is required. It may be that the food is not approved. Obviously the submission is at the same time copied to the Member States and the remaining Member States have a further 60 days to comment or object to the competent authority (the UK in our case). I should stress to your Lordships that all GM foods are assessed, including those such as refined oil from oil seed rape, which in composition are totally (100 per cent) identical to the non-GM food. The ACNFP as I have said has developed guidelines for deciding which if any of the food could be considered under the novel regulation for the so-called fast track procedure, the 60-day procedure. We have decided in committee that the only foods that can go through the so-called rapid route, the fast track procedure, are those in which there is neither novel protein nor novel DNA present. I should stress to your Lordships that we are erring constantly on the side of caution; that is very important. Perhaps I could give your Lordships one example that is in the public domain and is actually in the 1997 annual report. In there you will see evidence that we looked at five lines from a genetically modified potato where the company was asking for the fast track approval route through substantial equivalence. The argument that was made was that the product was highly refined and in fact was being developed to be used for French fries and crisp manufacture, and that any DNA that was present would be degraded. In committee we discussed this at some length and after our deliberations we concluded that there would be DNA, possibly degraded, possibly not, there certainly would be denatured protein present in the product and therefore we did not approve those particular five lines as suitable for substantial equivalence. I cite that example to your Lordships just to emphasise the way the Committee's deliberations err if anything entirely on the side of caution. I apologise for such a long answer but I think it is a very important subject.

Lord Grantchester

  674.  I wonder if you would please enumerate the direct and indirect effects that ACNFP takes into account when considering the safety of a food or feed. Perhaps you would elaborate on the cross references or databases you use to build up a picture of the individual application.

  A.  The safety assessment takes into account not only intentional changes that result from modification but any other unintentional changes that may occur, for instance, changes in levels of key nutrients, natural toxicants, and in particular—and I know this is very important—the level of potential allergens, the allergenic potential, of any new proteins. Obviously, in consideration of these things it is very important to draw on any information that we have available. There are databases. For instance, if we are looking at the source of the gene and the protein sequence we can compare against one database for example, SwissProt, which is a database of known allergens. We make substantial use of that. Again I should stress to your Lordships that in some cases the data simply is not available and therefore we have to extrapolate from the data and we have to look within our experience, and I should emphasise that within the 15 members of the Committee plus myself as Chair there is a vast range of different scientific experience to draw upon to look at these issues in detail. Sometimes the expected changes are deemed to be unpredictable but in fact they have been discussed in committee. If I can give you an example, one of the things about which there is very little controversy is genetically modified tomato purée. I will not at this point in time go through the advantages of that and the reasons why that product came into being and on to the shelves, but as a result of that one unexpected effect was that the tomato absorbs during its growth less water, and obviously there are knock-on advantages in terms of cultivation and range of climatic conditions and so on, but I have seen it reported in the literature that it was a surprise (it was certainly no surprise to myself, because I am very much involved at the processing end, being a biochemical engineer) that, in fact, during the processing of that product (which is a process whereby water has to be removed; it is almost a condensation to make the purée) less energy was required because there was less water there in the first place. That is not a health effect I know but that is just an example of perhaps an unintentional change. I am sure it was not in the minds of the developers at the initial laboratory stage to produce a product that would be less energy intensive in terms of its processing but that was just a simple example of a knock-on effect.

Lord Gallacher

  675.  Professor Bainbridge, are you satisfied that GM foods are as safe as foods already on the market? How confident are you that GM foods will not have an unforeseen effect in the longer term?

  A.  This is obviously a crucial question and one which we must address with some competence if we are ever going to reassure the public and allay many of the fears that we hear about. Certainly in terms of the deliberations of the Committee it is absolutely crucial that we give very detailed consideration to the nature of the gene insert, its level, its location and expression, and, as I have already said, to the nutritional profile of the food, the composition of key toxicants. I have to say that our agricultural system is based on crops that over centuries in some cases (decades in others) are a result of natural mutations, strain selection, hybridisation, and in some cases we know very little about the genetic composition and stability—we are learning more all the time—of some of these key nutritional crops, so I am content that for the GM foods that have been approved not only do we have a much greater knowledge base but they are as safe as their non-GM counterparts. If I could address that question and to help to allay some of the public fears, the ACNFP is looking into the practicality of setting up a post market monitoring system. I should stress that this is not because we do not believe that what we are doing is stringent and rigorous and it is not because we do not believe in our results. It is because we are very well aware of the need to provide added consumer reassurance and in the unlikely event of any unforeseen effects being seen in the longer term then hopefully with that system in place we will be in a position to identify them and react accordingly. We have held some open meetings. We held one in March and we now have an agenda date in December of this year where we are going to make final recommendations that we will obviously pass on to Ministers in terms of setting up post market monitoring. I should add, because I think it is very important that your Lordships should be aware of this, that those meetings will be attended not only by the scientific experts but also by an invited audience from a range of interests representing consumer interests, retail interests and indeed the pressure group interests.

Lord Wade of Chorlton

  676.  Listening to how you have answered the questions so far, I get the impression from what you are saying that there is nothing inherently within the genetically modified structure that in itself can add any possible danger to a foodstuff.

  A.  Our principle is to err on the side of caution. We have only approved four types of GM product, as your Lordships know, that is, the chymosin, the tomato purée, soya and maize. We have received many applications that have not actually been given final clearance and I have to say that a great deal of concern is addressed at developments that are still very much at the laboratory stage. If these are developments that are food related they in due course will come to the Committee and be considered with due diligence and care and consideration, and there are obviously other aspects of concern that are being addressed. If your Lordships were to ask, "Can you give a 100 per cent guarantee of the safety of these foods?", I would be being deceitful and betraying science if I were to say "Yes, I can," because no food, conventional or GM, can be 100 per cent safe. Something that I quote quite frequently when I am talking to consumer groups is that if our common standard potato, totally non-GM—your King Edward or whatever variety it might be—were to come to the Committee today as a novel food (For we do deal with other novel foods apart from genetically modified foods.), given our regulations it would not be approved because, as your Lordships know, it goes green and it does produce certain toxins and we would look at that and would probably look at the level of those toxins and say "No, this is unacceptable." We err very much on the side of caution but we never can say, given the understanding that we have of risk and risk assessment, that any food is 100 per cent safe. If you talk about allergens, milk for instance, one of our staple foods, no-one would ever think about banning milk or saying milk is unsafe, but there are some people who are quite seriously affected by a milk allergy.

  677.  Does the GM element of a food that has a non-GM comparable food add any risk whatsoever that is not there in the inherent food? That is what I have been trying to get a feel for, how you respond to that concept, because some of the comments you have made have suggested that there is no difference at all, that you cannot find a difference between a GM product and a non-GM product when they are similar in other regards. How much added risk do you think a product acquires when it has a GM element compared to a similar product that does not have a GM element, or do you think there is any at all?

  A.  What you would need to do is to say, "What is added?" You would look at the genes that are added that are not natural genes to that food, ie the novel gene, and you would say, "That might be a gene that is present elsewhere but it is novel to this particular food product", and then you would look at it in the context of the total genome of the food, you would look at how that gene is expressed, in other words what that gene actually does, and if that gene for instance is producing a protein you would look at the structure of that protein and you would look at that protein and say, "Does it match anything that is in any database for allergens? Does it confer upon that particular food the ability to produce a new toxin? Does it confer anything upon that particular food that could have some environmental effect?" and so on, and then you would look at that insert each time on a case by case basis.

Lord Gisborough

  678.  Professor, have you so far had any foods through you where you have not said that you want more time but have actually said, "No, no, no; do not come back"?

  A.  In my short experience, no. Things that we have not approved have been not approved because we have said, "No, it is not suitable for the fast track; provide more data", or because we have asked further questions. If you were to say are there some things where I could sit here and say, "No, no, no", I could. Certainly I have heard of things that are going on in the laboratory, perhaps not in the UK, and I would say no. I do not at this point in time see that there is any advantage in some reported gene transfers, but that is me talking as a layman. That is not me talking as the Chair of the Committee.

Lord Grantchester

  679.  We have received evidence from some plant breeders and they have seen developments in plant breeding as a continuum with genetic modification at the extreme end. I wonder if you would like to comment on that view of plant breeding because what was expressed to us was that there were several technologies, such as hybridisation, that could lead to novel foods, and that genetic modification was by no means the only way to produce a novel food. Could any more orthodox plant breeding technologies theoretically escape the net because they do not come under the banner of genetic modification?

  A.  First of all I would perhaps refute the statement that genetic modification is the extreme end because it is simply an intervention but the final product is not doing anything that could not happen anyway naturally. As I have said before, it is controlled in that it is deliberate and we understand which genes are being transferred, how they are being transferred, how they are being inserted, and we know a lot about their behaviour once they are inserted. The beauty of that as a technology is that it is directed and it is much more rapid. I do have some concerns about techniques whereby chemical mutogenesis for instance is used and there is no mechanism for controlling what goes on in the genome. I also have some concerns about some technologies not to produce GM foods necessarily but for instance there was an article today in The Times, about the so-called "terminator" technology, and again that could be seen to be applicable only for commercial gain. There still are a great number of issues that are not really the remit of the Committee but they are issues that in the broader sense are very necessary in terms of this technology and indeed all plant breeding technologies which are connected with intellectual property rights, patenting etc. There needs to be a great deal of clarification of many of these issues. I hope that has answered the question.

  680.  In your Committee you are confident that there are not any other technologies which perhaps avoid coming before your Committee. Would the fact that they are novel foods by itself mean that they would come before your Committee?

  A.  The technology might not come before the Committee if it is not to produce a novel food but if the technology produces a novel food, it does not matter how it is produced, be it GM or any other technology, it would come before the Committee. Indeed, a food which has been part of the food chain elsewhere in the world—there are very few of them left—not the type of food supply chain that we have but something that had not been a substantial part of the UK diet or the European diet, should I say, would have to go before the Committee. We are not just looking at foods for new purposes, we are not just looking at GM foods. We are looking at a range of foods that are novel to the UK. A novel technology, as indeed you speculate about, producing a food product: we would look at that food product and obviously part of that examination would be to look back at how the technology obtains that, at how the product was derived from the laboratory bench through the field through to the food product.

Lord Jopling

  681.  Professor, I wonder if I might illustrate the point I want to make by quoting a short bit from the current New Scientist which says, talking about genetic modification: This is not an extension of classical breeding. In classical breeding it is possible to cross relatives to create hybrids. You can cross a donkey and a horse and get a mule. But you cannot cross a donkey and an oak tree. With genetic engineering technology can cross all the biological boundaries. You can make mice with human growth genes and you can have firefly genes lighting up tobacco plants. The question I want to ask is: do you think there is something that gives inherently added danger if you step beyond the limits of classical breeding? Do you think, once you have stepped over that and started crossing donkeys and oak trees, there is some new inherent factor in that process which ought to make us more cautious?

  A.  First, there are a thousand and one articles where this very issue is raised and they usually start by quoting animal examples which are obviously very emotive. Having said that, when we are talking for instance about pharmaceutical use the technology is much more accepted, so there really are two issues anyway. I will try and answer the question with reference to food. It does not matter in one sense where the gene comes from. It is how the gene behaves when it is inserted into the product that is going to hit the market place. What we have to look at is how can we protect the consumer? As I tried to articulate, by going through the decision tree approach and by analysing the data step by step all possible scenarios—what if, what if, could this happen, and so on—we try and ensure that we have got as close as we can be to absolute safety. As I have already said to your Lordships I cannot sit here and say I am happy or confident that there is 100 per cent safety because I could not say that about any food product. There are however inherent dangers in taking the technology too far. There are issues again that are outside the remit of the Committee that should perhaps be within the remit of a much broader biotechnology committee, about approval of the experiments in the first place, is it wise to go along this route? There is a great deal of controversy, if I could give you an example, about taking fish genes (fish, because they are cold-blooded and they have particular genes that give them the propensity to survive in cold climates) and introducing those into plants so that you can increase the agronomic practice and plants effectively become frost resistant when they were not before and so on. There is a great deal of concern because the technology would be seen to be transporting an allergen into a plant. Therein lies the message. We have to look at each example on the case by case basis, look from where the gene comes, where it is going and how it will be expressed and what it will do. I have to say that again what is or what is not approved on a laboratory scale is not really the remit of the Committee. As a scientist and as someone who is active in biotechnology in the much more generic sense I have very clear opinions but I would not like to confuse your Lordships in the sense that I am trying to clarify when I am speaking as Chair of ACNFP and when I am giving you my personal opinion. You are right: there is a great deal of concern and we do need to reassure the public at all stages through the regulatory process.

  682.  Speaking for myself, I would be most intrigued to hear your personal opinion.

  A.  There is a great deal of commonality in the genome. We all have our own individual genes. There is a great deal of basic commonality in nature. The genetic code applies from the simplest prokaryotic organism right through to man, if we can indeed put ourselves at the top of the evolutionary tree. I sometimes have my doubts. There is a commonality in genes so it is sometimes not so spectacular to say we will take this gene from A to B, could this be terrible?

Lord Wade of Chorlton

  683.  What you are saying is that although a donkey and an oak tree are different, it is the combination of genes that make the difference and not the individual genes in either a donkey or an oak tree. Is that it?

  A.  Yes. It is more than just the combination. It is how the gene is expressed and what it does when it is in its new location if you like. Through the medium of genetic modification we can in the laboratory do things that would not happen because of the laws of nature in terms of breeding that would not happen naturally.

Lord Moran

  684.  I was not clear about one aspect of your original answer to Lord Jopling because at the beginning you said that it did not matter where the gene came from. What mattered was how it behaved in the organism you put it into. Then later on in your answer you said there was a great deal of concern about various things including where the gene came from. I was not clear whether in fact your view that it does not matter covers all aspects.

  A.  No, it certainly does not. Perhaps again I can illustrate that by giving you an example of something which your Lordships may refer to later. It does matter in a sense not so much where it comes from but what it actually does when it is inserted. Obviously we have paid a great deal of attention to genes that confer antibiotic resistance for instance. In a sense perhaps it is not accurate to say it does not matter. It would be much more precise to say that we must look at everything on a case by case basis and the crucial thing is how the gene behaves, in our case, talking of novel foods, in the food or food product used for its intended use.

  685.  I would like to ask a question about what I think are known as "new genes". How sure are you that you can predict a gene's activity when it does not have a proven history of food use? Do genes without that history of food use present particular problems to you? Have any products containing such genes been presented to your Committee?

  A.  Most of the genes that are being inserted into food crops at present already have a history of food use. Obviously, in making an assessment of safety of proteins as they are expressed by novel genes it is very important for us to consider what previous human exposure there has been to such proteins. All such considerations are set out in detail in the guidelines that accompany the Novel Food Regulations and I do have (and again will leave for your Lordships) copies of the guidelines and also copies of the electronic database that your Lordships can refer to. Indeed that is provided to all potential applicants as well, so we try to make the process extremely transparent and as user friendly as we can. To answer your detailed question, a if a gene product (and I stress "gene product" rather than "gene" per se) does not have a history of consumption, then obviously we require the appropriate information. This will include toxicological studies, studies on mutogenicity, information on stability, and so on, on a case by case basis. At the moment we have not been presented with anything at committee where there are non-food genes incorporated into the food. We are at the moment looking much more at genes that exist being transferred from a prokaryote into a food or from elsewhere. The crucial thing therein is that as we get experience of working with the Novel Food Regulation, as indeed we get more experience as more and more GM foods come to market in Europe and indeed around the world, it is crucial that the appropriate databases are set up where they do not exist and are accessed where they do exist. This is absolutely crucial because it is impractical and unrealistic if and when the technology picks up in speed and advances for every single case to re-invent the wheel as it were and where the data is out there we must make sure that we access that data and use it and apply it to the particular food product that is under consideration.

  686.  What precisely is a gene product as opposed to a gene?

  A.  The gene is the DNA. It is the sequence of bases. The gene product is the protein that that gene would express. That could be an enzyme, it could be a food protein or whatever.

Lord Gisborough

  687.  Just as you can mix two soft metals and get a hard one as a result, to what extent would it be possible to have two benign genes which collectively then became toxic?

  A.  That indeed is a possibility and this is why we look at toxicity very carefully. There is a gene that is naturally in the non-manipulated product and a new gene comes in, a novel gene is inserted into it, and those two together (you do not necessarily have to transfer two genes) could have a toxicological effect, so it is very important that we do look at toxicological data very carefully. In that context, as your Lordships know, there is the COT, the Committee on Toxicity, and there is cross-membership. The Chair of that Committee is a member of ACNFP and we do occasionally, when we are not satisfied with the explanation in terms of the toxicological data or where we require more, would refer a submission from ACNFP to that Committee. We each have a quite clear remit: and theirs is to look at this or that toxicological aspect.

Lord Rathcavan

  688.  Professor, you mentioned fish genes being used in plants. Could you develop that and explain to us what role you think this might have in the future?

  A.  I will develop that. These things have not come to Committee so I will not develop it in the sense of speaking on behalf of the Committee. As a scientist I will try and develop those arguments. It is quite crucial if we are going to feed the growing world population that we can extend the range of crops, not only the one that I referred to previously but being able to grow crops with an extra harvest a year or increase the latitude at which a crop can grow because it becomes frost resistant, but it is also crucial that we can grow for instance crops in arid regions of the world and so on. This is very much in the minds and eyes of those companies that are developing the technology and very much, I should say, involved in the sense of the blue skies research that is being done in academic establishments. That research is not being done in a haphazard way. Those experiments are all conducted after thorough scrutiny and approval through the appropriate sources. I think that work will continue. I think much of the work is blue skies and much of it will never see commercial fruition. As and when that particular product that has been developed in that way with one of these genes comes to the Committee it will come with a very detailed dossier of information and we will look at it, as we do now, on a case by case basis. When I said it does not matter where the genes come from, I do not mean that and I will not reiterate that but in a sense it is not so much the origin of the gene. It is how that gene is expressed and what happens. It is not the remit of the Committee to take on board the whole gamut of the ethics and the whole range of genetic manipulation. I have to say however that we never lose sight of ethical considerations. We do have on the Committee an ethicist. At the moment it is Dr Michael Rice who is also a scientist but very much involved in the ethical debate. Certainly in terms of the Committee's deliberations it is not a question of our having our scientific debate and then saying, "Over to you, Mr Ethicist", or, "Over to you, consumer adviser. What have you got to say?" Our ethicist and our consumer representative take a very active role in the Committee's deliberations. To that end it is quite difficult when we are appointing people to those posts in the Committee to find someone appropriate because we have to have someone that can participate in the scientific debate but also, as I say, represent the ethical viewpoint and we always are very aware of that. At the end of the day it is only with this attention to detail, this stringency of debate, that we are going to win consumer confidence.

Lord Wade of Chorlton

  689.  You have already mentioned allergenetics. Is more research needed on allergenicity as suggested by the recent Royal Society statement? Is this the only area which requires further research, or are there others which you believe may be problematic?

  A.  It is not the only area that needs further research and I will come back to some of the others. I will answer the question in terms of allergenicity first. The issue of allergenic potential is one that the Committee takes extremely seriously. It is a fascinating issue. I am confident that the procedures we follow as far as we can enable us to identify potent allergens. However, and this is very important, we have to recognise that there is always going to be someone somewhere that is allergic to something in food and maybe that allergy might arise for no apparent reason in that individual. There is a need to further refine the tools if you like that are available for identifying allergens. As an aside, there is also a need to further carry out the medical side of allergy, why do people become allergic. MAFF is funding work in this area to underpin the safety assessment procedures. The issue was raised for instance when we had one of our joint meetings with COMA, the Committee on Medical Aspects, and Dr Stephen Strobel, who is an expert on allergenicity, pointed out to that meeting that 50 years ago when peanuts were not part of the food chain there were no peanut allergies, at least not recorded. Ten years ago when the kiwi was not part of the European food chain there were no allergies to the kiwi. We are now very concerned for instance as a nation about peanut allergy. It is interesting that in Korea the weaning diet for infants is actually mashed peanuts and in that country there is no known recorded peanut allergy. I am trying to give your Lordships a feel for the importance of the work and it is a fascinating area and a crucial one that we always try to address. The problem—and we have to be very sure that we can address this in any way we can—is that the allergenic potential (and I have tried to bring this out in the case of peanuts for instance) may only be apparent after several years. We have to estimate whether it is a one-off case because, as I say, there always will be people allergic to the other thing, or whether it is becoming a serious problem that ultimately will affect the health of individuals and perhaps in a wider sense. The only answer to that are the mechanisms that we are involved in now in setting up in terms of long term monitoring, long term surveillance of these foods. As part of the research that MAFF is commissioning they are developing an animal model for allergic response and allergenicity. I have to say that the research is not easy; it is not straightforward. I could perhaps quote an example of a test being developed. If a test were developed and 14 test sera were developed for potential allergens (much like the serum test that we do when people do have an allergic response) and if all 14 prove to be negative, it is still not possible within the laws of binomial statistics and the laws of mathematics to say that that is 100 per cent guarantee that there will be no allergenicity. That still only gives 95 per cent confidence limits. The problems are very difficult. Obviously, if you happen to be the individual that has an allergy to peanuts for instance, peanuts not being a GM food—I do not want to muddle the debate but an allergy that people are well aware of—it is absolutely crucial. You do not want a 95 per cent confidence limit. You want to be 100 per cent sure of the safety, in the case of peanuts, that peanuts are absent. There is something else that I often say in terms of public interface and trying to explain things to consumers. When the public sometimes has to grasp, why bother with GM for food use, is it actually necessary, I often say that one of the things that will make the technology come of age (this is still very much at the laboratory developmental stage) is developing a peanut genetically that is non-allergenic. That is in the laboratory. I do not know; it is impossible to say. Some people say five years, some people say 10 years before that would be developed, so it would come to the Committee before it hit the market place. That I think will go some way to turn the whole debate around in terms of GM food.

  690.  That would imply then that you must know what it is in the peanut that causes the allergy amongst certain people who eat it.

  A.  They are starting to identify it, and I am saying that if we knew that, the technology would not be five or 10 years around the corner; it would be maybe a year or 18 months around the corner.

  691.  At this stage you do not know?

  A.  At this stage that is part of the process that we are doing. I also have to say that the famous case, the Brazil nut case, is a clear example where the problem was identified early on, and it was not a UK issue anyway, but that is something that would be identified and we have learned a great deal from that. For instance, once you have identified gene sequences that produce proteins that are allergenic, there are a lot of sophisticated things that can be done. You cannot remove the sequence because you would remove the protein entirely but you could turn the genes round back to front so that they are not translated and that might remove the allergenic potential. There is a lot that can be done. I agree with the Royal Society report. There is more research that needs to be done, and indeed MAFF is at the moment commissioning some research. I do not think that is the full story. There is an awful lot, not only the genetic type of research but also a vast amount of medical research, that needs to be done in terms of the human physiology and allergies.

  692.  You mentioned that you might have some thoughts on the other issues that might be problems that you might look at. Are there issues other than allergenic issues which you feel need more research?

  A.  Issues that need more research are mainly concerned with surveillance. There are a great number of issues—and again I am speaking outside my remit in one sense—which have been identified by DETR concerned with the growing of many of these plants in the field, issues of herbicide resistance, separation distances. Many of those issues are requiring more research and indeed that research is being undertaken. Many of these issues emphasise the importance of perhaps I could say a holistic approach. We have the range of food advisory committees. I have already mentioned COMA fairly extensively. I have already mentioned the Committee on Toxicity. I have mentioned ACRE. There is a wide range. What is absolutely crucial is to step back and I would like to step back. It is useful in a sense being a part-time Chair of a Committee. It is not my paid job because I go back to a much wider view of biotechnology. Indeed, I run a faculty that covers just about every aspect of science and engineering that a university faculty could cover. I would like to step back and say, "Look; there are broad issues" and I know there is some concern about those broader issues later on.

Lord Willoughby de Broke

  693.  Professor Bainbridge, earlier on you mentioned antibiotic resistance. I would like to ask about that if I may. Your Committee in 1996 recommended that, in general, antibiotic resistance genes should not be used and, in particular, those with bacterial regulatory sequences were considered inadvisable. Has your Committee modified its views in the light of the EC Scientific Committee's decision to approve the release of the ampicillin-resistance maize?

  A.  The short answer to that is emphatically no, it has not. If I could elaborate on that, the ACNFP stands by the guidance that it issued and indeed published in 1994 and 1996 in the case of antibiotic resistance markers where it looks at the toxicity of the gene product. Obviously the clinical, including the veterinary, importance of the gene and the likelihood of transfer are the crucial issues. That is the likelihood of the transfer of the marker gene and its expression in gut organisms. Perhaps the next stage, whether it is then expressed into human cells, is an issue that is so remote but we still consider that. I see no reason why the Committee should alter its guidelines in the light of the EC Scientific Committee's decision on the Ciba-Geigy maize. In this instance the ACNFP was of the view that the risk, in this case it was an ampicillin gene and its associated regulatory sequence transferring to the gut bacterium, was very small but it was finite and we stand by that. Indeed, the European Committee accepted that the risk was small and finite, so in one sense we agreed totally. Where we disagreed was how we would implement that. I think it is evidence to your Lordships again that if we have to make a judgement, as we do (and we have to try and base that judgement on the best scientific evidence that we have available where that evidence simply is not there because we have to learn from experience and we are learning all the time), we would always err on the side of caution. I personally have some concern—this is speaking generically, not as a committee member; we all do, the public does—about the very widespread use of antibiotics in medicine and in agronomic practice which I know is controlled and controlled very carefully: another whole area of argument. If I could finish by referring to the technology, not the applications—we are focusing today obviously on the applications of the technology—the genetic modification, gene transfer techniques, that technology is moving on extremely rapidly. It is quite amazing, the pace of change. Issues that were discussed in 1994 and in 1996, even issues—and as I have said before I have only been the Chair for 15 months—that were pertinent 15 months ago are becoming less relevant, and I quote one member of my Committee who, when we were looking at a particular product with an ampicillin gene, said, "Why is it there? It is sloppy genetics." The practical techniques that allow us to transfer and to manipulate genes in a controlled way where we had to use in many cases in the past antibiotic resistance markers have improved, the science has moved on, and it is possible now either to use that marker and to excise it, to chop that bit and its product out of the modified gene, or indeed use a different technique to transfer the DNA. It is becoming less of a problem whilst all around us antibiotic resistance is becoming a major problem. We must in committee continue to re-focus on this and always apply our very precautionary approach in this context.

  694.  Are you aware at all—perhaps not in your Committee—that companies are aware of the concerns that there are different methods now which they would use in preference to using antibiotic marker genes?

  A.  Absolutely. We do not have the responsibility of ensuring that the research and development arms of major multinational companies are up to date but it is obviously in their commercial interests that they are and in my experience they are very much and work very closely hand in hand with the universities. In some parts of this technology it is impossible to say who is further afield: the leading universities or the companies. Certainly the company that put a submission to the Committee (and, as I say, one of my colleagues referred to it as "sloppy genetics") are in no way unaware of the need to remove that gene because the submission simply was not approved and it went back worded in a somewhat more technical way than that but with a recommendation that things could be done with that particular product and should be done. Certainly part of the public exercise that I am very proactive in, in publicising the work of the Committee and the openness and the transparency approach, is to refer to antibiotic resistance and refer to the precautions that we do take and the way that this particular issue, if I were to put a hierarchy of issues, would be very close to the top at one point, is dropping now, not because of less importance but because of the way the technology is developing.

  695.  Are there any other genes or groups of genes which ACNFP would think it inadvisable to release?

  A.  There could be but again I have to say that what we would do is look at them on a case by case basis. I have mentioned mutogenicity and we would look at genes that might infer mutogenicity. I have mentioned stability, I have mentioned toxicity, I have mentioned allergenicity, so I think they are the key areas.

Lord Rathcavan

  696.  Are you saying that with the less sloppy genetics now available you should produce a maize without the disadvantages of this particular Bt maize?

  A.  That will come.

  697.  When is that going to come along?

  A.  The techniques are very complex and it is not possible at this point in time to say that it is impossible not to use any antibiotic resistance marker. It depends on the type of insert and the length and how it has been transferred. There is a whole range of technical issues there. Sometimes it is not possible to excise it without excising part of an express protein, but ultimately there is no reason why. Again it is in the future. We are not in a position to say, "This maize that has been approved should be withdrawn and now you can produce this one because it can be produced without an antibiotic resistance marker." We are not at that stage yet. It is not possible to do that. As the technology advances the companies are looking for new modifications, new inserts, for a whole host of reasons and I am sure in the future if I were asked, this would be one of the ways in which the technology and the means to producing the product would actually go.

Lord Redesdale

  698.  What is the relationship between ACRE and ACNFP?

  A.  Very good. We meet regularly. In fact, I met with John Beringer yesterday morning. We do have common membership and the secretariats work very closely together, which is very important given that they are reporting to two different Government departments, but they do. There is a great deal of interface and day to day exchange between the two secretariats. One other example of working together is that we are looking at arranging meetings of advisory committee chairs. I think it was last week or the week before that many of the advisory committee chairs met with Sir Robert May to see how we could best bring about this. There have also been joint meetings between ACNFP and ACRE but not in the past 15 months. I think relationships are very very good. With the emphasis that is placed at the moment upon the changing of the remit of ACRE somewhat and the current press releases from Michael Meacher, etcetera, I am sure that that good working relationship will continue and indeed be strengthened.

  699.  What environmental assessments are being conducted on GM foods in developing countries? Do you have any control over the multi-nationals?

  A.  For all viable GMOs used as food that come into the European system there is obviously a requirement to provide an environmental risk assessment similar to that required under Article 90/220. Where a crop is intended to be grown in Europe this risk assessment will be undertaken as part of the procedure for issuing marketing consent. If the crop is grown in America then there is the American FDA with their systems that are different but very much parallel to ours, but the control that we have over crops that are grown in developing countries really starts when the crop is imported into Europe and then it would come under the European regulation.


 
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