WEDNESDAY 1 JULY 1998

DR KENNETH BAKER, MISS ANN FOSTER and DR STEPHEN WATERS

  360.  From disease resistance to antibiotic resistance. One of the public concerns of potential damage to health from GM crops has been the use of antibiotic resistant marker genes. Is this antibiotic resistance in GM foods a genuine cause for concern? Is it your aim to phase out the use of such antibiotic resistance marker genes and, if so, by when?
  (Dr Waters)  Perhaps just to put antibiotic resistance markers into a broader context, the marker genes are an essential tool for the molecular biologist because they allow him to select out individual plants which have received the gene of interest—so that the marker genes are actually just a tag to allow the molecular biologist to quickly identify those plants which have acquired the trait of interest. Currently there is a very restrictive number of marker genes which are available. Antibiotic resistance marker genes are one example. Herbicide resistance is another example of a marker gene which could be used for this selection process, but the number of alternatives beyond those two examples is very limited indeed, and so companies have habitually been faced with the choice between antibiotic resistance markers and herbicide resistance markers. This, we recognise, has raised public concerns about the possibility that this could contribute to the important problem of antibiotic resistance in the broader sense. However, having said that, if one looks at it from a purely scientific point of view now, this question has been addressed by a lot of experts both in Europe and internationally. The question has been addressed by the FAO, the WHO, and it has been examined by the European Union scientific committees. It has been examined by regulatory authorities in Switzerland, the United States, Canada and Japan, and the overwhelming conclusion has been that, at least for those products which have been reviewed to date, the use of these antibiotic resistance markers does not represent significant risk either to human health or to the environment. These authorities came to this conclusion after consideration of the likelihood of the transfer of the gene from plant material into microbes, specifically in the gut, and the conclusion was that the likelihood of that happening is negligible. The assessment then went on to look at the possibility or the likelihood that this could somehow compromise the therapeutic value of antibiotics and the conclusion there again was that the likelihood was negligible on the grounds that these genes are already present in high frequencies in natural populations and, indeed, the genes were taken from natural populations in the first place.

  361.  Nevertheless, the concern persists. Is there any prospect of any marker genes being developed that would not have these disadvantages in the future or any possibility of removing the marker genes before they come to the commercial release stage?
  (Dr Waters)  We have recognised the public concern and we have accelerated our efforts, at least internally in Monsanto, to develop alternative methods. There are methods which have worked under experimental conditions, such as the Cre/lox system which, in theory at least, is able to remove genes once they have been inserted into the plants. There are also alternative selective marker systems which have been developed, but they are not yet at the point where they are a viable alternative to antibiotic resistance markers. Our intent is to move towards these alternative systems as much as possible, once they have been developed to the point where they are a viable alternative and we would de-emphasise the use of antibiotic resistance markers as these alternatives become available.

  362.  You have said that the opportunity for antibiotic resistance to enter the food chain is not impossible, you said it is negligible, so there is a very remote possibility for that to happen, if I interpret what you were saying correctly.
  (Dr Waters)  The experts who have looked at this have used classical risk analysis, which involves assessing the likelihood of an event occurring and then, secondly, if it were to occur, what the consequences would be, and in both cases the conclusion was that the risk would be negligible and, therefore, the combination of the two unlikely events is an extremely unlikely event. One can never say, though, that the risk is zero, but certainly taking into account all of the available scientific information, the risk is considered to be negligible.
  (Dr Baker)  Or vanishingly small, I think is the term used in the United Kingdom, whatever that means.

  363.  Can I ask your views about the problem of the genes escaping from crops to relatives of the crop in the wild, and how big a problem is it, in your view. How big a risk is it and how should it best be dealt with? Is it dealt with best by segregation and refuge areas or is there a possibility of producing crops that do not reproduce with a male sterile or only female crops? Is that the best solution? Also what happens if gene stacking takes place, that is to say, weeds build up a resistance to more than one herbicide as a result of out-crossing or back-crossing? Is that a big problem and how should that be dealt with, as you see it? Finally, do you have any products under development currently which are resistant to more than one herbicide?
  (Dr Waters)  There is a series of questions there and I will try and cover them in my response. The notion of genes escaping is probably a misunderstanding of what actually occurs today, because genes are never contained within a plant, but genes are flowing as part of pollen grains in nature right now, so every time a pollen grain is shed from a plant, then tens of thousands of genes are shed into nature. Gene movement is a natural phenomenon and, therefore, one has to focus in, on a case-by-case basis, looking at each particular crop and each particular trait which is introduced into the crop to try and assess whether that gene movement has any consequences or not. Taking oil-seed rape as an example; oil-seed rape is known to be an out-crossing crop. Its pollen is shed and pollen can move to nearby crops or it can move to a related species and hybridisation can take place, and this has been happening for centuries, so the more critical question is whether the fact that you have introduced a new trait does somehow confer a selective advantage to those species which receive the gene through cross-pollination. In the case of a herbicide resistance trait, perhaps to use the Roundup Ready trait as an example, we have looked at the possibility of whether by acquiring the trait, related species and indeed related plants from the crop itself would have some selective advantage which would allow them to prosper at the expense of surrounding plants. The conclusion from those studies is that the trait itself does not change the morphological characteristics or the fitness characteristics of the plants, or of any plants receiving the trait through cross-pollination, in the absence of a treatment with the herbicide and there is no change in the fitness characteristics of these plants. However, if one applies the selective agent, in this case Roundup herbicide, then clearly those plants would survive at the expense of those surrounding plants which do not have the herbicide tolerance characteristic. Clearly in a natural situation, one would not be spraying a herbicide in that situation. The area of interest is more in the agricultural fields where farmers may have to deal with plants which have acquired the herbicide resistance gene through hybridisation. We have examined the consequences of this and, in most cases, the conclusion has been that the current methods of control would be adequate to control those plants. For instance, what farmers do today to control weeds is essentially to use cultivation methods or selective specific herbicides, and both of these techniques would be equally effective on plants with and without the herbicide resistance trait. That would also be valid for plants which have acquired two herbicide resistance traits through hybridisation, so having acquired two traits would not affect their ability to be controlled by cultivation, or the use of selective herbicides. So in that specific case of oil-seed rape, containing a herbicide tolerance trait, we do not believe that out-crossing is going to result in adverse environmental effects. It may change the way that farmers control weeds today and so there may be some agricultural implications, but, as I have said, in most cases there would not be a change in agricultural practices, but in certain specific cases, farmers may have to change, for example, their rotation practices or their weed control practices in order to accommodate the transfer of the gene to a related species.

  364.  And male-sterile or all-female crops?
  (Dr Waters)  There has been some work on chloroplast transformation so that genes would be inherited by the maternal part of the plant rather than the paternal part, which would prevent transfer of the gene through pollen flow, but would still leave open the possibility of hybridisation in the other direction, that is, pollination by a related species so that the progeny could also contain the gene which has been introduced. I am not particularly familiar with these techniques, but that is something which one could perhaps explore as a means of at least reducing the flow of transgenes away from the crop.

  365.  Are you developing products which are resistant to more than one herbicide?
  (Dr Waters)  We are developing products where different traits are combined; for instance, insect-protected traits and herbicide resistance traits, but, to my knowledge, we have not developed products which combine two different herbicide resistance traits.

  366.  We seem to be moving towards an ever-diminishing number of large seed companies and given the fact that they are likely to have very few GM varieties available, it means that there could be an ever-decreasing variety of crops used in agriculture. Are you concerned about this and moves towards monoculture? Are you concerned about the effect of a crop failure and to what extent are you covered by insurance as a company for some horror situation which might emerge from the introduction of genetically manipulated varieties?
  (Dr Baker)  You have suggested that there would be a movement towards monoculture, but I think in the last few years there has been a focus on a certain number of crops already with or without biotechnology. Obviously one of the reasons for that is because, as breeders select varieties, they are selected for certain traits which are better than others. Again this is somewhat peering into the future, referring to your earlier question, but we can imagine that some of those older varieties which have been used, if they are given these newer traits through biotechnology, will come back into use again. So in many ways it is possible that we would get a trend away from the existing trend towards monocultures, which answers your second question about crop failures. In terms of insurance against crop failure, we, as most other companies, accept civil liability in any case with respect to what may go wrong with our crops and we are required to take full responsibility for that. In terms of special insurance, to my knowledge, we do not have any special insurance in the sense that we already take responsibility and coverage for anything we do as a company.

  367.  So if something went wrong with a GM variety and you got sued, you would be covered by your existing insurance?
  (Dr Baker)  We have coverage, yes.

  368.  And you believe you would be fully covered, do you?
  (Dr Baker)  This I would have to put to our lawyers, but we believe that we are adequately covered.

  369.  Your second paper sets out the very considerable input savings that appear to be made as a result of growing GM crops, but there is a very wide degree of scepticism in this country regarding those claims insofar as what we have heard from the evidence we have taken, and I would like to quote to you something from a paper which has been produced in evidence to us by English Nature, which is a statutory body which advises the Government. They say here, "There is no evidence that the new crop management system associated with growing genetically modified herbicide tolerant crops will reduce overall herbicide use in the countryside. Even though GMHT crops may require fewer herbicide applications, there will probably be a large increase in the total area being sprayed because certain broad spectrum herbicides would be used for the first time on growing crops, like sugar beet and oil-seed rape, which were previously damaged by herbicides", and they end by arguing that, "There would be an increase in the use of broad spectrum herbicides". What do you say to that argument?
  (Dr Baker)  Let me start with an answer and I think maybe there is a technical response also. The first thing to say to that comment is that, based on our customers' experience, that is to say farmers mainly in the Americas, North and South America and Australia, purchase these products because of a benefit for the farmer. Now, where does the benefit come from? It comes from, amongst other things, a reduction in the input costs and a reduction in chemical use. Let me put it another way: that if there were an increase in costs for the use of herbicides or indeed any other products such as insecticides, we would probably not sell the seeds. Therefore, I think the evidence from the farmer is that he buys them primarily because of the reduced overall cost. That is one of the things we document in our second submission. In terms of the overall increase in herbicide use, maybe, Dr Waters, you can comment on that. I think the same argument goes, that there is no logic in a product which increases the amount of chemical use on a more expensive seed as there would be no reason to buy the product in the first place.
  (Dr Waters)  I think the comment was that there would be an increase in herbicide use and I think they ( English Nature) mention that, as an example, there would be an increase in the use of broad spectrum herbicides in sugar beet. The latter statement is true, since we would be promoting the substitution of the herbicides which are used currently by Roundup which is a broad spectrum herbicide. If one looks at weed control practices today in sugar beet, virtually every sugar beet farmer applies herbicides because competition from weeds early on in the development of the crop has a significant effect on yields and, therefore, farmers are currently making (usually) three trips across the fields and applying a mixture of different non-selective herbicides. In the case of tolerance to a broad spectrum herbicide, farmers can now substitute that mixture of selective herbicides by one single broad spectrum herbicide, so there will be an increase in the amount of broad spectrum herbicide used, but it will be at the expense of the herbicides which are used currently. In this specific example, this new approach provides considerable benefits in terms of the reduction in the amount of active ingredient which is applied to the sugar beet fields, but also as well as from the benefits which spin off from that, such as the characteristics of the products which are used and other potential benefits, like the possibilities to move to conservation tillage practices, so one has to look at the current systems in comparison with these new systems in a broader context.

  370.  On the question of monitoring, can we return to the proposed draft revision of Directive 90/220 where in that draft revision of the Directive, the Commission raise the question of monitoring for environmental impact after commercial approval has been given. What is your view of the feasibility of such a programme and, secondly, the desirability of such monitoring?
  (Dr Waters)  I think to some extent we have addressed this question previously, but perhaps just to summarise that, I think post-marketing monitoring is certainly no substitute for a thorough risk assessment prior to the launching of the products. That risk assessment involves addressing, to the extent that it is possible, future developments and future generations. Secondly, we are certainly supportive of post-marketing surveillance programmes. This would be part of the standard product stewardship programme that we have for all new products. In fact, for the products which are currently going through the regulatory process prior to the introduction of the 90/220 revisions, we are actually including surveillance proposals in our regulatory submissions, so we are voluntarily taking the step of ensuring that correct surveillance networks are in place which would allow feedback in the event of an adverse effect. Monitoring, in my mind, has a different connotation. Monitoring is more active; it is actually going out and measuring things. I am certainly supportive of that in the event that a specific risk has been identified and it is clear what the objectives of such monitoring should be. If a potential risk has been identified, then one should develop scientific protocols to understand what that risk could be, how that risk would be manifested and how one could measure the risk. So my response on monitoring would be that this should be restricted to those products where a specific risk has been identified rather than monitoring for the sake of collecting information.

  371.  Whilst I would not wish to put your company in the same league as the tobacco companies whose monitoring of the effect of tobacco on human health gives rise to certain questions, would you not agree that it would be better that monitoring be done by an outside body and not by the companies themselves?
  (Dr Waters)  Well, one example I can think of is in France, where a committee has been set up as well as at the European level; a group of experts has been established to look at the question of insect resistance management in insect-protected maize, for example, and that committee is composed of national experts. Those experts have devised the monitoring protocols and they supervise the implementation of those protocols. Certainly when it comes to monitoring, there is something to be said for having independent scientists doing that. In the case of the surveillance, clearly companies who develop the products are best placed to collect information on any unexpected events which take place in the marketplace, simply because we have the connections to our customers and to the distribution chain, although, having said that, there are technical institutes in most countries which are also a part of that network, so there is also a means for independent feedback as part of the surveillance programmes.
  (Miss Foster)  In terms of food safety, you will probably be aware that the Advisory Committee on Novel Foods and Processes has already begun to address the issue of monitoring and I think in terms of public perception, it would be preferable for it to be done by a respected independent expert body, but of course we would wish to co-operate in whatever way was thought necessary.

  372.  Could I raise briefly the question of segregation. Can European consumers expect in future to be able to source non-GM soya from the United States or not? What, as you see it, is the likely progress of segregation in the United States in that area? Are we correct to assume that originally you were not in favour of the United States soya producers segregating GM from their non-GM crops?
  (Dr Baker)  Maybe I will answer the second question first as to whether we were in favour of something or not. I do not think we are in a position to be in favour of segregation because we have no control over that; we sell the seeds to the farmers. It is probably true to say that we underestimated the emotional impact here of the fact that it was not able to be done. Nevertheless, your first question was whether it will be available in the future. My understanding is that segregated crops are available now, provided one places an order for them. They are on the market and, I would suggest, always have been, but of course it depends on the company requiring the product actually placing the order for the crop itself.
  (Miss Foster)  What we are seeing in the United Kingdom, though, is that the market is now working where consumer demand for non-GM sources has developed, and this is something that the retailers and the manufacturers are seeking to satisfy and they are doing this by identity preserved sources. If we look at, for example, the recent announcement by Iceland Frozen Foods that their own-brand products from the 1st May will not contain GM sources, that does illustrate that the market mechanisms can and do work if there is consumer demand. Also there has to be a determination to work this all the way through the chain from the harvest right through to the final product.

  373.  Well, thank you very much. I think that is probably all we have time for. The Committee is extremely grateful to you for having come to give evidence to us. It has been quite a long session for us, but then of course you are an exceptionally important company in this area. Do you appreciate your significance in this area and the significant impact that you can have on whether genetic modification in agriculture is accepted broadly in this country and in Europe and that much may depend on how you conduct yourselves?
  (Dr Baker)  We accept fully that responsibility as a company and we appreciate your interest in hearing our views on many of the subjects which you have raised which relate to questions of public concern. In terms of our importance, I think we think of it slightly differently in that we have many competitors in the field and I do not think we necessarily regard ourselves as being in the lead, but we do appreciate our role in this new developing area of what is called life sciences and being one of the key players in it.

  374.  Well, thank you, Dr Baker, Dr Waters and Miss Foster, very much indeed for having come here.
  (Dr Baker)  Thank you, my Lord Chairman.