WEDNESDAY 1 JULY 1998

DR KENNETH BAKER, MISS ANN FOSTER and DR STEPHEN WATERS

  340.  May I now ask my next question. Would you like to comment on your experience of bringing GM crops from the US to the EC, and what is the EC indecision and unpredictability that you referred to costing Monsanto?
  (Dr Baker)  In terms of the relationships between the United States and Europe, the regulatory system that we have here is somewhat more complicated in terms of the way it operates than that in the United States. I would characterise it as less efficient I think overall. The regulatory stringency in terms of the evaluation of the data is, I would say, roughly equivalent in both places. What that is leading to in particular with these crops which are globally traded is an imbalance in the approvals for these products around the world. As commodities in particular are widely traded, that impacts on the trade of those products because if they are not approved in one place then they cannot be imported, or if they are produced in one place and not approved in another place then there are problems with importing them. In terms of what does it cost Monsanto, that is a difficult thing to put a figure on. I can tell you that the delays that we experience here, which are to a large extent due to paper pushing, are not a question of the evaluation of the product which is all done very well scientifically. It is a question of working out what the regulation really means in terms of its operation and bureaucracy and so forth, which means that we need to keep people employed while all this is going on, so that we are ready to answer questions. Those delays can be several years and we are using people sitting around waiting to answer questions about the bureaucracy, not about the scientific nature of the products. I cannot put a figure on the cost, but it is actually costing us a lot in people in a non-productive mode.

  341.  So in terms of the safety precautions taken both in the EC and in America they would be about equal. It is not a question that any system is different from another in terms of the certainty that it gives about the product being safe. It is merely about the way that the system is administered that you would say is less efficient in Europe than it is in America?
  (Dr Baker)  I would say that is the prime difference. In terms of safety evaluation, maybe my regulatory colleague can comment.
  (Dr Waters)  I think if one looks at the data which is provided and the safety assessment which is submitted in Europe and one compares that to the safety assessment which is submitted in the United States and even in Canada, Japan and Australia, you will find a high degree of commonality in the type of information which is required to come to a conclusion on safety. Where Europe differs, as Dr Baker said, is in the procedures which are much more complex in Europe because it involves a review by 15 Member States rather than a single centralised authority. Obviously 15 countries means a range of cultures, different perceptions of risk, and so in a European framework it is difficult to come to an agreement on what is an acceptable or unacceptable risk. Those sorts of discussions are essentially what have slowed down the decision making process in Europe.
  (Dr Baker)  Some of those are unavoidable. Let me give you one example: the translation of any material into all of the different languages of the Community and making sure that each translation means the same can lead to extensive delays and problems. I am not suggesting that we should do away with the languages but there is an issue.

  342.  Has your experience of the EC regulatory system differed depending to which Member State you apply?
  (Dr Waters)  The answer can be divided into two parts. The first part concerns research and development and the second part concerns applications to market products throughout the EU. As far as research and development is concerned, we have been testing products across Europe since 1990. We have experience in about 12 different countries now. I would say that the situation today is relatively consistent. In the earlier years after the adoption of the European Directive there were much more divergent approaches because it was a learning process for both notifiers as well as regulatory authorities. Over time, because of dialogue between the various competent authorities, there is now a much more consistent approach to dealing with risk assessment for Research and Development purposes. Obviously there are still differences between countries. We spend a lot of time filling out different application forms in different languages to test the same plant material. For the moment there is no procedure for having an EU-wide authorisation which allows you to test plant material in multiple countries. It is still very much a direct contact with the regulatory authorities on a country by country basis. As far as marketing is concerned, we have had experience with four different countries in Europe with 10 different products. Our experiences have differed. As we discussed a few moments ago, those differences really have not been at the scientific level. The type of data which is expected by the different countries is quite consistent and our experience has been that the review process has been science based and has been quite timely. The difficulties have come once the application has been forwarded to the rest of the Community so, therefore, to respond to your question I think that our experience across those four countries where we do have experience is quite consistent. It is only at the later stages of the process that we start to run into procedural difficulties.

  343.  Could I ask you what you think about the Commission's proposed amendments to the Directive 90/220? You are very critical in the paper that you have kindly sent us about Directive 90/220 as it exists. Could you say a bit more about what you think of the proposed revisions to 90/220? Are there any major problems with the existing Directive not addressed by the Commission?
  (Dr Waters)  Perhaps rather than go into all the details that are outlined in the written evidence I will respond by outlining the key aspects of the regulations as far as industry is concerned.

  344.  Of the proposed amendment.
  (Dr Waters)  Yes. I think in general terms the way we would define a workable regulation is a regulation which is firstly based on sound science; secondly that the approvals are given in a timely manner and there is a degree of predictability about the procedure and the amount of time that it takes to complete the safety assessments. Thirdly, we think regulation should be consistent with international regulations, and fourthly, the administrative procedures should be proportional to the amount of risk. If one applies those basic criteria to the Directive, as it stands today, it clearly falls down in each of those areas. With respect to the revision, I think it does go some way to correcting the inadequacies of the current Directive. To give you some examples, there is a genuine effort to try and bring clarity to how one goes about risk assessment. The current Directive does not provide clear indications on what one does with the information which is provided, how one processes that information and how one comes to a conclusion about whether a product provides a threat to the environment or to human health. The new revision proposes a standardised approach to conducting the risk assessment, so that is certainly a positive aspect. Another positive aspect is the inclusion of referral to the European Commission's Scientific Committees. This should strengthen the scientific approach to the safety assessment. Another positive aspect is improvements in transparency of the process. There are now provisions for public consultation during the review which we consider to be positive. On the other hand there are certain weaknesses which the Commission itself pointed out when it reviewed the Directive at the end of 1996, and some of those recommendations have been taken into account. Others have not.

  345.  Could you say something about the ones that have not in your view?
  (Dr Waters)  An example would be the timeliness of decisions. One of the major barriers to approvals has been delays which have taken place particularly in the phase of drafting of the Commission decision, and voting by the Member States. Time limits have been introduced but not for every stage of that process, so there is still a reasonably high degree of uncertainty about the procedure itself and how long that procedure will last. Other concerns are that the complexity of the Directive has actually been increased by placing time limits on the authorisations. It is now proposed that any authorisations must be renewed every seven years. This adds to the lack of predictability and the uncertainty in the procedure from the point of view of companies who are investing in the development of products. There is only the certainty that products will be authorised for seven-year periods and it is not assured that the authorisation will be renewed. Also I mentioned risk and administrative procedures being linked. The new proposals for the Directive, although they categorise products in the Research and Development part of the Directive, they do not do that under the marketing part of the Directive. For example, products which are imported for processing purposes but which are not intended for planting in the EU must undergo a similar safety assessment to products which are to be planted here. There is no attempt to try and introduce simplified procedures for products where the risk is considered to be lower than it is for products which are planted in the EU.

  346.  In the paper you kindly sent us, in paragraph 21 you say: "... some Member States are using national variety registration procedures to add further conditions to the marketing of GM varieties. These conditions are, in some respects, contrary to Community (90/220/EEC) decisions, are not science-based and are an additional burden to industry, which decreases the competitiveness of European agriculture without providing additional safeguards." Can you expand on that statement and can you tell us which are the Member States you are referring to in the evidence you put before this Committee?
  (Dr Waters)  Perhaps as a word of clarification first of all, before a genetically modified variety can be marketed in the European Union it requires clearance under a number of pieces of regulation. It requires authorisation under the 90/220 Directive, it requires authorisation under the Novel Foods Regulation and it also requires that the variety enters national variety registration procedures which are usually administered by national Ministries of Agriculture. The purpose of those variety registration procedures is to ensure that the product provides agronomic advantages for farmers and also to characterise the identity of a particular variety. The example that I was referring to was not a Monsanto product but it is the first product which has been grown in the European Union, which is the insect protected maize. This product went through the 90/220 review process. It was subjected to a thorough environmental risk assessment, where all the possible questions that one could ask about interactions with the environment were addressed and the product was approved for planting throughout the European Union without any specific conditions attached to that with respect to monitoring for interactions with, for example, microbial populations in the soil and in the gut of the animals which are fed with the maize. In light of this 90/220 decision the varieties were then registered under national variety procedures in both Spain and France and in both cases the variety approval was given on the condition that further studies were carried out to investigate interactions with micro-organisms and other organisms in the environment. The concern there is that these interactions were considered under the European procedures, and they were considered to represent no adverse risk for the environment, yet because varieties had to go through this additional regulatory step these Member States used this as an opportunity to attach additional conditions, relating to risk which had previously been considered to be negligible.

  347.  Do you know of any other countries besides Spain and France who have been resorting to these tactics?
  (Dr Waters)  To my knowledge these are the only two countries where genetically modified varieties have been approved for cultivation in the EU.

  348.  In the evidence you gave, in paragraph 16 you said that many considerations should be out of scope. Could you give us some indication of what considerations you think should be out of scope for the regulators?
  (Dr Waters)  In the written evidence a number of examples were given. Some of them date back several years but they illustrate the way in which the Directive is being interpreted differently by different Member States, and perhaps part of the problem lies in the lack of clarity in the scope of the Directive itself. To give you a couple of examples, the first one concerns criteria which have no relation to protection of the environment or human health, which is the objective of the Directive. An example of this is objections which were raised by Member States concerning the labelling of seed bags as well as food products derived from the genetically modified grains. Clearly this labelling is a criterion which is not related to the safety of the product, but Member States raised objections to the marketing of products on the ground that the labelling proposals were inadequate. That is one example of a non-scientific criterion being used as part of the safety assessment. Another example, which does relate to scientific criteria which would be covered by other legislation, is the example of the presence of pesticide residues in the genetically modified grain. These aspects are covered by the Plant Protection Directive 91/414, yet these questions were raised in the context of the 90/220 Directive and should have been considered to be out of the scope of 90/220, but within the scope of another piece of legislation.

  349.  Going back to the labelling question, what might be considered out of scope then would perhaps raise its head in a different area in the issue of segregation. You would not know how to segregate certain types of foodstuff. You talk about very strict guidelines and constraints on what should be regulated. Do you not think those could actually be counter productive in the long term?
  (Dr Baker)  In terms of the labelling under the 90/220 Directive, as Dr Waters was saying, it concerns the product, in other words in that case the seeds which are being sold. They would be labelled anyway. We in fact put that in our submission. In response, it was the Commission which was arguing that labelling was out of scope to be included in the regulation, even though de facto you would sell those seeds labelled. In other words, this question of out of scope is in fact more to do with the lack of clarity in the regulation itself as to what is included and what is not included. We have no problem with it, but it must be clear in terms of what we are supposed to provide in terms of evidence and data and that is where the debate comes from to a large extent.
  (Dr Waters)  As a follow-up to the discussion on labelling, the response of the Commission to this impasse was to actually go back and modify the Directive to require labelling of the seed bags even in the absence of any environmental or human health concerns. Therefore, while the Directive was being modified, all of the product approvals were put on hold and companies initially volunteered to label seed bags as containing genetically modified seeds; it is now mandatory to do so. This was an example of an out of scope objection but it nevertheless blocked the approval process and in order to remove that blockage the Commission resorted to modifying the Directive to make this an acceptable objection.

  350.  On labelling for information, at paragraphs 19 and 37 of the Monsanto evidence there is reference to labelling for information being a barrier to trade. Would you like to elaborate on that?
  (Dr Baker)  I think first of all one should say that this is a comment rather than a point of criticism. Labelling for information can always be instituted by any community for whatever reason. Generally speaking, labelling is information which relates to some type of safety or health consideration about a particular product but, as has recently been done here in Europe, labelling can be required for informational purposes, and also to tell the population what is in the product. However, in this particular instance with commodity crops which we mentioned earlier on, they are traded internationally and, of course, there are derived food products from them. Then there are requirements in that trade as to how you label products from other nations and therefore one gets into an argument about whose labelling regulation is the best and what is consistent with the international trade rules. So there is an area here which needs to be looked at in terms of the effect of labelling on international trade and on other third countries. It is not to say that there is not a trade issue here, but one needs to be a little careful as to how this is all implemented.

  351.  In the evidence which the Sub-Committee has been having on this subject, I think it would be fair to say that most of it has signified that consumer acceptability is enhanced if labelling is adequate. Do you agree with that?
  (Dr Baker)  I think we have said that earlier on. If we take the example of the potato, in fact even though they were higher priced, they were labelled and there was increased consumer uptake of that particular product, so, generally speaking, yes, I think we would agree with that.

  352.  Could I just ask a further question on labelling. Do you think then that there should be some international labelling standards that would help with these international products and who might do it?
  (Dr Baker)  I would say there should be some consistency in international standards.

  353.  Would you see it as something that the WTO might be asked to look at?
  (Dr Baker)  Undoubtedly it would be.
  (Miss Foster)  These issues are also addressed by Codex's evidence.

  354.  You have been involved in marketing GM crops now, as you have just explained, in several countries. What lessons in allaying public concern have you derived from these experiences and what response has there been so far to your new advertising campaign?
  (Miss Foster)  One of the lessons that we have learned is that we were marketing GM soya in Europe before there was any agreement at EU level on labelling requirements. In the United Kingdom the situation was helped vastly by the fact that we did have a voluntary code of labelling devised by the food industry. One lesson to be learned is that it really does help if all these provisions are in place before the food is marketed, otherwise people have this sense that it is there by stealth and that is not the intention. In the United Kingdom we are lucky in that the IGD, the Institute of Grocery Distribution, has devised a voluntary code of labelling which is being followed by the United Kingdom food industry and that has been very helpful. We welcome the fact that we do now have an agreement at EU level on labelling provisions. The importance of giving consumers information has been a very important lesson and that means information before, during and after the introduction onto the market. Again we have to acknowledge all of the activity by the United Kingdom food industry, both manufacturers and retailers and the Government, in terms of giving consumers more information. As a company, we were of course so far removed from the ultimate market that we did not initially become involved in this process, but we very much welcome the efforts by those who were much closer to their consumers and who knew the kind of information and reassurances that people required. One of the areas that people are still unsure about is the degree of regulation that this food goes through before it is permitted on to the market and I would certainly like to think that we would be able to reassure consumers more in terms of the regulatory process. We have to bear in mind that in the United Kingdom we have been introducing this food against an overall background of consumer concern about food safety, about risk assessment and about confidence in the regulatory authorities. I hope that a lot of these concerns will be addressed by the creation of the Food Standards Agency. As to the response to the new advertising campaign, we are encouraged by this. It has been running now for almost four weeks. The feeling was very much that it was time for us to come out and support the rest of the food industry and not put the entire burden on them, but to take responsibility ourselves for providing more information, so there has been a public information campaign where, as you know, we have acknowledged quite openly that there are differences of opinion. We believe that it is important that people understand this and they have access to the range of opinion about genetic modification in the hope that people will read the available information and make up their own minds. We publicise a call centre and our website address. So far, we have had over 2,000 calls to the call centre and 700 of those people have wanted to speak to our live operators, and mostly they have been questions from the everyday consumer wanting to know more about the science, the regulatory system, and the products in which these foods appear as food ingredients. We have sent out over 1,000 information packs and these information packs contain information from a variety of sources. We have been careful to include information from a range of different sources, from the Food & Drink Federation, from the IGD (Institute of Grocery Distribution)—the survey they did on consumer attitudes—and from the Institute of Food Research giving more information and in very straightforward and simple language about genetically modified soya. We have had about 7,000 visits to our website, so we are very encouraged by the response. Yes, there has been some criticism of the campaign, but in acknowledging that it is a controversial issue, we expected that there would be some criticism. Our overall reaction is that it has been a very positive exercise and we have received a lot of support from other parts of the industry. We have no regrets at all about embarking on this course of action.

  355.  It would appear that GM crops have been much more accepted by the consumers in the United States than they have in the EC countries. Why might this, do you think, be the case?
  (Miss Foster)  There have been a range of suggestions put forward for this. United Kingdom consumers are quite suspicious about the application of science and technology to the food supply, whereas in the United States consumers there are much more ready to accept scientific progress. There is also a distinction in the degree of confidence people have in the regulatory agencies. The Food & Drug Administration has developed over the years a degree of confidence that is not shared by United Kingdom consumers in our regulatory process for reasons that I think have been well rehearsed and we all understand. I think these are the two main reasons and there are certainly distinctions that we do have to take on board. It has also been suggested that in the United States consumers are much more relaxed about the argument that this brings benefits to the US agricultural industry, whereas again in the United Kingdom people do not appear to be as persuaded by arguments that GM technology could bring benefits for farmers.

  356.  Do you not sometimes feel that the reassurances that you give the public are somewhat over-comforting? I notice in the current campaign that you have, and I quote from it, you say that "rigorous tests have been undertaken throughout Monsanto's 20-year biotech history to ensure our food crops are safe and nutritious as a standard alternative". Dr Waters, I wrote down what you said a few moments ago with regard to maize and you said that it had been introduced, "...where all the possible questions...were addressed...", yet since that has happened, there has been a good deal of publicity, as an example, with regard to genetically modified maize with regard to possible impacts on lace-wing insects. Now, I do not want to get into the particular case of the lace-wing because that work, I understand, was done in a laboratory and in practical terms it seems extremely doubtful whether the lace-wing can get at the larvae of the corn borer. I do not want to get into the detail of that, but it is the principle. Can I ask Dr Waters, when all possible questions were addressed with regard to that type of maize, was that particular possibility addressed at that time or was the impact on the lace-wing a surprise to you when this scare story appeared from the laboratory work in Switzerland? I think it probably was a scare story. What I am getting at is, is there not a whole raft of secondary impacts of introducing genetically modified organisms which cannot possibly be covered in the initial stage of certification when you tell us, and I quote again, I rub your nose in it, as it were, "all possible questions were addressed"? It is impossible in scientific terms to address all possible questions when you are introducing something because there are so many other issues, like a different type of lace-wing problem, that could exist. Is there not a whole range of these things under the surface which could appear and does this not alarm you because it alarms the public?
  (Dr Waters)  I will certainly choose my words more carefully next time, and I should not have been so emphatic or so black and white. Clearly there is always a degree of uncertainty about any new product introduction. I think what the safety assessment tries to do is to establish beyond any reasonable doubt that the products are safe for the environment and for human health. One can imagine all sorts of questions, and the most obvious ones are certainly addressed as part of the safety assessment. Clearly one cannot address every imaginable question. Having said that, there are provisions in the Directive that once new scientific information does become available, such as the information you were citing, clearly this information would have to be referred to the regulatory authorities who would reconsider the assessment that they had done previously in the light of this information. In the specific example you cited, this clearly was addressed in the safety assessment, although this experiment that you referred to related to a product from a competitor company, but, generally speaking, the question of the effects of these plants on beneficial insects, such as lace-wings, has been examined in the course of the safety assessments. For example, in the case of Monsanto's insect-protected maize, we actually measured the levels of beneficial insects in the field during our research and development programmes, prior to submitting the marker applications. The results of these studies, which are field studies and which we consider to be more relevant than the results from a laboratory study, although we should not dismiss that because it is clearly important information and we should take that into account, but the question was asked and the question was addressed under the field conditions and the results of those field studies demonstrated that there was no impact of the Bt protein in the maize plants on the populations of the lace-wings. On the contrary, the levels of beneficial insects in the transgenic plots was actually higher than it was in those plots which had been treated with insecticides, so there were positive indications on the impact on beneficial insects. To go back to your point, clearly there is no absolute answer. One can conduct all of the safety assessments to prove, with reasonable certainty, that the product is not going to present a risk and one has to move forward on that basis, but leaving open of course the possibility to gather new information after the product has been commercialised and to continue to evaluate the safety of the products which have been marketed.

  357.  I think, if I may say so, that is one of the most revealing answers we have had in this enquiry. Just let me try a little further. You agree in that answer that the introduction of crops like this is in a way a leap in the dark, but so is the introduction also, I would agree, of new pesticides, new chemical applications to crops. I think the key question the public want to know is, is this leap. the extent to which it is a leap in the dark which we seem to agree about, a bigger leap in the dark with genetically modified crops than anything else we have known in the past in terms of agricultural development?
  (Dr Waters)  I would respond to that by saying that we would have a great deal of information prior to launching one of these products commercially. For example, in the case of soya beans, they have been cultivated and consumed for centuries, so we have a tremendous amount of information about the interactions between soya beans and the environment and also in nutritional terms, so one has to start the safety assessment from that platform. We are not talking about the introduction of completely exotic species or completely new molecules; rather we have a high level of understanding about the crop that we start with, and the genetic modification is a simple modification in terms of the number of genes which one introduces relative to the number that are already present in the soya bean plant. We are talking about tens of thousands of genes which are already present and, in most cases, we are adding only one or two genes, and because of the minor changes, one can focus the characterisation on the changes which are made. Before a product can be authorised for marketing one has to characterise the changes which have been made and one has to demonstrate that those changes are stable both over time and also in different genetic backgrounds and so that demonstration of stability allows us, at least to some extent, to project forwards and extend our conclusion of safety from the present to the future. That is the sort of assessment which needs to be done up-front, but that is not to say that these products are then put on to the market without any follow-up. On the contrary, certainly it is in our interests to make sure that the products that we market maintain the properties that we have demonstrated prior to launching them and we need to ensure that our customers are satisfied that the product is working as they would expect, so there is a whole system of product stewardship in place which allows ourselves, the distribution chain and our customers to follow the product under a commercial setting, and this network provides a mechanism for feedback on the product performance and any adverse effects, should any appear, subsequent to commercialisation. That sort of information will be quickly fed back to Monsanto and we would respond accordingly.

  358.  Could I just follow on from that question because it is a very interesting point that Lord Jopling has raised. I seem to remember that when Professor Klausen developed the landrace pig in Denmark in the 1950s, which he did with traditional breeding methods, and there was no use in those days of biotechnology, it was a long time before he bred out all the throwbacks that came as a result of his change in breeding patterns. The outcome of this new pig was enormous because consumers had a different type of the product which they wanted. Would you agree that in fact that system of developing new breeds or new products as a result of traditional breeding methods is just as likely or in fact is probably more likely to produce something where you do not know what might come out of it than the GM produced new products? Would that be your view?
  (Dr Baker)  I think it is certainly true to say that the regulatory stringencies for what you might call traditional products are not at an equivalent level, which is I think really what you are asking, and it comes back to Lord Jopling's point.

  359.  But, as a science, that is the issue. Here we are in the position where for a long, long time it has been the economic need and pressure to improve continually the products that we are dealing with in the agricultural world and there are plenty of examples of how this has happened in the past, but we have used traditional systems. Those traditional systems are not in themselves necessarily simple or straightforward, as I know from experience, and they create all kinds of side-effects unless and until it becomes pure. Would you argue from a scientific point of view that the present methods, using GM and biotechnology, to produce new products and breeds is a cleaner, a more precise system of doing it than the old system of breeding and developing new products and new species?
  (Dr Waters)  It is a new tool for breeders. Breeders will continue to hybridise existing varieties and select out those offspring which provide the best performance. The introduction of genetic engineering allows the breeder to be more specific in what he does. For example, using traditional breeding methods, he may be able to produce progeny which have improved resistance to disease, for example, but there may be associated with that a decrease in the yield potential, simply because one is dealing with multiple genes and multiple interactions. In the case of biotechnology, the breeder is now able to introduce a specific gene for disease resistance into a high-yielding variety without having to be concerned, or certainly not to the same extent, about interactions, so it is a much more precise tool and it allows the breeder to gain in efficiencies.