WEDNESDAY 3 JUNE 1998

DR NIGEL J POOLE, DR DAVID A EVANS and DR SIMON W J BRIGHT

  58.  Good morning. May I welcome you to the Committee and thank you very much for coming to assist us with our enquiry into genetic modification in agriculture. Could I ask you first of all to introduce yourselves and say what your different responsibilities are?
  (Dr Evans)  Good morning. My name is David Evans. I am the Research and Development Director of Zeneca's agricultural businesses. On my left here is Nigel Poole who is responsible for regulatory affairs and public affairs for our biotechnology business. On my right we have Simon Bright who has led much of our biotechnology research in recent times and presently is responsible for technology collaborations. Nigel and Simon have spent just about all of their careers in biotechnology and have worldwide reputations in this field. Indeed, both are honorary professors at universities. In addition, Nigel is a member of the Advisory Committee on Release into the Environment.

Chairman]  Thank you very much. We have your written evidence, for which the Committee is grateful. Perhaps we can go straight into questions and ask Lord Gallacher to start.

  59.  Dr Evans, what are the most important implications of this technology for agriculture, consumers and the environment?
  (Dr Evans)  Essentially as an international company Zeneca operates in over 146 countries. Indeed, 96 per cent of our sales are generated outside the United Kingdom. We take a worldwide perspective on this issue. Of course our headquarters and our research are based in the United Kingdom. Biotechnology is absolutely critical to our research programmes, in future product offers and in the integration of crop management technologies. We believe that biotechnology provides distinct consumer benefits in three major areas: first, productivity, then quality, and then variety. In terms of productivity, in my lifetime it has been necessary for the world to increase its food production three-fold and, given current population trends, that is bound to continue and we shall need to optimise the inputs from technology to meet those targets. In addition to population growth, food security is also impacted by the requirement, the desire, for quality and variety in food, particularly in developing countries, so we have a major job to do and we require the technology there. Within this biotechnology plays a vital role. Biotechnology regulation is our contract with society to allow us to develop safe products to present to this integration of crop management technologies. From my viewpoint what is necessary for Zeneca is that my job is about investing in research and development plans. We require a framework of regulatory clarity to allow us to make optimal choices in what and where and how we pursue our research and development aimed at these ends.

  60.  What crops are being worked on at the present time? Is the focus still on herbicide and pest resistance or has it moved to developments of more direct benefit to the consumer?
  (Dr Bright)  Biotechnology techniques are being applied essentially to the full range of crops which are being improved through breeding and selection means, so this is another tool to the armoury for crop improvement. The initial focus is on single gene traits such as modification for herbicide selectivity or insect resistance. The new crop protection genes and technologies which are going to come will do things which are more difficult than the first generation products, such as controlling fungal diseases and controlling difficult-to-get-at beasts such as things which attack roots. As well as improving crop protection and crop productivity, there is an increasing amount of research going on around the world and in our company on things to do with understanding what is the genetic basis of quality and then doing something about it. If I could give a couple of examples, we are interested in how the genetic basis of flavour works and how that can be improved. We all know in principle that eating vegetables is good for you. We can now begin to get at the underlying science, the genes that control the production of nutrients so that you can then have programmes to improve the nutritional qualities of fruit and vegetables. That is an example of a direct quality attribute. We also have work going on which has its primary benefit in environmental improvement. For instance, we have got a research programme where, by expressing a particular enzyme in a plant that goes into chicken food, you can then reduce the amount of phosphate pollution that comes out of intensive chicken farming practices. There is a whole range of activities both within our company and in other companies and to my mind this is something that is going to be very pervasive technology which will provide extra choices on how you do things in agriculture, both for productivity and for quality improvements.

  61.  You mentioned, Dr Evans, that you operate in 146 countries, I think, and you said that your developments were of particular relevance in developing countries. Perhaps you could enlarge on that and tell us something about what crops you are working on in less developed countries' agriculture.
  (Dr Evans)  The first point to make is that by means of enhanced crop protection technology does allow countries to grow crops which hitherto were not possible. One good example would be bananas which suffer from a very debilitating disease which is presently not well controlled by current technology. Providing solutions to this problem (it is a disease called black sigatoka) is one of our research objectives. In addition to crop productivity it is clear that our technology worldwide provides benefits to the productivity of food, in other words the yield enhancement of food, in many countries. The technology is applicable to crops in general.

  62.  What percentage of your research or expenditure is going in less developed countries' agriculture as opposed to that of developed countries?
  (Dr Evans)  We have a crop list which is relevant worldwide. Essentially we operate worldwide so I find it difficult to give an exact answer to that. Our perspective is entirely global. The United Kingdom is actually a rather small percentage of our market and we have to operate globally. For example, in crop protection we are certainly number one or number two in Asia. In the world we would be number three, so our perspective is entirely international.

  63.  I can remember being told 10 years or so ago by Lord Rothschild that one of the things that would have the biggest effect on the agriculture of less developed countries would be if you could create a wheat which had a capacity for fixing nitrogen from the atmosphere. Could you tell us what you are doing about that and what prospects you see for that sort of wheat being produced?
  (Dr Bright)  Ten years ago I had that on my list of things which were impossible and I have now moved it on to my list of things which are just very difficult. The underlying science about what is required to make that productive symbiosis is coming along. It is quite clear that this could have a benefit. As a research manager I am still dubious about advertising when we can crack that problem. It is certainly very difficult, but I think it is one of the things if you like that you can put out there as an aspirational target to say, "I would like to understand how that works", and by doing that you can either replace or supplement fertiliser application. I would not hold my breath and say that within the next 10 years there will be a product like that. I think it is very difficult.

  64.  Can I move on from the speculation area into an area where you have achieved a product in the market and ask you at what stage is your application for growing GM tomatoes in the European Community?
  (Dr Poole)  I think a bit of history might help first of all. This was an invention in Europe but we did most of the development in the States. We then wanted to try and bring it into Europe because the process in this kind of technology suits our invention much better in Europe. We decided to bring it to the United Kingdom first of all and there were several reasons for that. One of the most important reasons was that at that time the United Kingdom already had some very well respected regulations and, apart from the Netherlands, no other European country had those regulations, so we were able to get that comfort. We have to have a regulatory framework before we can bring a product on to the market and that was in place. It was a United Kingdom invention, the United Kingdom is our base, and I suppose we were also getting rather fed up with being told that Europeans are Luddites and would not dream of eating modified food. We wanted to test that and we also wanted to test whether our approach to the market and working partnerships would actually work. As you know, we brought it in in 1996. To date we have sold well in excess of 1.6 million cans in Safeway and Sainsbury. All that is sourced from California, it is processed in California and it is shipped over here. It is sold side by side with tomato puree produced in Italy. I suppose if you like we are putting Italian farmers out of jobs. We have now asked the European Union if we can grow and process this in Europe—it will grow in the southern states. That application we deliberately held back for 17 months in the hope that there would be some clarity in the European regulatory system. We submitted it via Spain and it is now 17 or 19 months since we had it submitted. Spain approved it, it has gone to Brussels, it has gone out to the Member States. It was considered by the Scientific Committee of Plants a month ago, which we believe is a favourable report. We are now waiting to go through the next steps. In our written evidence we have given the timescale of going through US, Canada, Mexico as well, so you can judge the timescales.

  65.  So it will not be until 1999 at the earliest?
  (Dr Poole)  We will not be planting and growing commercially until 1999. This is the growing season. The tomatoes are in the ground already. It is too late this year.

  66.  Is there any particular reason why it is being held up as far as you know?
  (Dr Poole)  No; I think it is going quite fast through the European system compared with other products. There were two objections. One was from Austria on the presence of kanomycin, and one was from France on a general issue about genetic modification, but both those were considered by the Scientific Committee and we are waiting for their official report now.

  67.  As far as animals and fish are concerned are you doing any work in the genetic modification of either?
  (Dr Evans)  No, we are not.

  68.  First I ought to declare an interest as a farmer and as a non-executive director of a company which deals in international trade on meat products, fish and milk products. I would like to ask you about the difference between the EC and the US. Would you comment first on the differences between the EC and the US approval processes from the point of view of the applicant, both in theory and in practice? Then I would like you to comment on your experience of bringing GM food crops from the US to the EC.
  (Dr Poole)  We have worked in many countries. If you look not just at the US but Canada, Mexico, Australia, you actually find the questions you are asked are very similar to the ones you are asked in Europe and that is not surprising because all those countries are using a risk assessment system to evaluate the risk and make a decision. That is a scientifically based system and is a worldwide approach. The questions are the same. The amount of detail in Europe is slightly more but the difference we find comes in the next phase. It is actually deciding on those answers we have offered. That is where we seem to be hitting problems. This lack of transparency about the whole process and who makes the decisions is a real problem to industry at the moment. We need a route map, as Dr Evans said. Our most important criterion for a decision to develop a product is a clear regulatory route map and at the moment it is very difficult to get that in Europe.

  69.  Could you tell us about your experience of moving GM crops from the US into the EC?
  (Dr Poole)  As a company we were the first to bring into Europe a product which was approved in the States and sold in the States. Frankly we had no problems with those tomatoes.

  70.  Lord Chairman, I am afraid I neglected to declare an interest in the last question I put. I am a farmer. I also have some shares in your company. We have had a document from our specialist adviser on "The Gaps in the Regulatory Oversight of Biotechnology in the United States". You have not seen this. There was a briefing for the Committee. I will read to you two sentences at the beginning. It was a briefing for this Committee. He says: "There is no regulatory system for ensuring the safe use of biotechnology in laboratory or factory use where the organism is not to be released into the environment." He goes on to say a little later: "The United States Government decided there should not be special legislation to assess the safety of the products of biotechnology." I find that in rather startling contrast to the comment in your paper, paragraph 11, at the end, and again I quote: "Meanwhile, the USA has in place a regulatory process which is widely respected by both industry and consumer." I do not know if you would like to make a brief comment but what I think would be helpful is if you could take Dr Kinderlerer's paper away with you and let this Committee have your comments on it because there seems a very clear contradiction between what you are saying and what he is saying.
  (Dr Poole)  There is actually not a contradiction. May I develop it? First of all, in our presentation we are talking about a deliberate release into the environment and not laboratory work. Way back at the end of the eighties both the United States and Europe were considering how to frame their regulations, and we have to go back right into history. The Americans said they could actually, under their law (which is a different legal system from ours in Europe) fit in the biotechnology regulations under products' legislation. To get approval for example for the tomatoes we had to get approval from the United States Department of Agriculture to grow them, to transport them and to process them at the federal level. We also had to get state level approval if we crossed state lines. The US GM law is under plant protection legislation they have already got in place, and to consume it you have to ask the FDA if they can see any reason why this product should not go on the market, which is again a catch-all phrase they use in their legislation. That regulatory legislation did not exist in Europe. At that time, remember, we were still individual European States. We were moving towards a European environmental process in 1992, and therefore Europe decided to set up its own legislation. I come back to my original comment that when you get down to it the scientific questions we have to answer in both lots are virtually identical.

  71.  Could I ask you whether you would send us a report on this?
  (Dr Poole)  Yes, of course.

  72.  You have already told us quite a lot about your experience of the EEC regulatory system on the tomato issue. On other issues, or indeed on the tomato issue, have you had a different sort of experience depending on the EEC country you have applied to for approval?
  (Dr Poole)  We have worked in the Netherlands, France, Spain, Greece and Portugal. I think as a general statement we are extremely impressed with the regulators, the people who have to carry out the regulations, in all those countries. We find them very professional. I suppose you would expect us to say it, but we are very impressed with the United Kingdom regulatory system in place. We think it works very well for the United Kingdom. The problem in the other countries is that you get buffeted by political issues which can cause confusion and that is where the delay comes in. The track is actually better in the United Kingdom than in most other countries. It is pretty good in the Netherlands as well. Once you go into countries with less experience, naturally they are trying to build their experience and you start being asked about issues which are not part of the risk assessment.

  73.  And these are being asked by the regulators?
  (Dr Poole)  They come through the regulators because that is who we are communicating with. I am not au fait enough with the political system in those countries to say who is actually originating it. You are asked questions about public acceptance, or "Will our farmers accept it?", which are not part of risk assessment. You are asked, "Is there a need for it?", which is not part of the risk assessment process which is concerned with safety.

  74.  If I could apologise, I should have declared an interest before I began my questioning. Perhaps I may do that now. As Chairman of English Nature, the Government's statutory adviser on biodiversity, I have an interest in biodiversity, and I am also a member of the Minister of Agriculture's advisory group. Can we move on to the issue of company responsibility, or indeed anybody's responsibility, in this field. Do you think the company should have a responsibility, for example for consulting stakeholders?
  (Dr Poole)  I would like to take that back again to the tomatoes because it does show the way we like to work. You need many other things to come together, not just to bring the product out but to make a commercial success. The stakeholders are an essential part of that. When we started the launch of the tomatoes we communicated—and, I want to emphasise, we listened to—many different parts of society from the media to civil servants, to Members of Parliament, Lords, members of the European Parliament, local people and consumers. We tried our best to build their thinking and their thoughts into the way we behaved. When we came forward we thought this would be the first such product in Europe. It is easy for us: it is our culture, but we wanted to make sure that there was choice. That was never a question. The reason we labelled our tomato puree was not for safety reasons at all. It was simply because we wanted to give information to the consumer. If you went round the stores you would find leaflets, and very well written leaflets, if I may say so, by Sainsbury and Safeway, actually explaining what biotechnology was and how it was done. That is how we approached our case. The answer is yes, our stakeholders must be involved.

  75.  What you have described sounds like a communication process. Do you think that consultation with stakeholders should be part of the regulatory regime?
  (Dr Poole)  One of the problems we have in Europe is actually working out which box you belong in. They are all equally important. Our concern at the moment is that the risk assessment system is based on very well tried, very well respected scientific principles and that is the basis of our risk assessment process. That is determining safety. Issues such as, for example, is it needed or does society want it, belong in this building at the end of the day. There are other issues which are equally important. I think biotechnology in Europe has become a lightning rod for all these other debates which are going on and I think we will need to separate risk assessment. The rule on that is to determine safety. That is advice given to a minister who then decides. Other issues are just as important and we do not decry them. They do not belong in the risk assessment process.

  76.  But would you see them as part of the overall regulatory process?
  (Dr Poole)  I believe in a democracy, yes.

  77.  In the event of something going wrong with a GM crop, who would be liable?
  (Dr Evans)  GM crops are no different from other crops or indeed other products. The producer would be liable.

  78.  The grower?
  (Dr Evans)  The producer can be defined as anything from the grower right through to the importer.

  79.  In your opinion do consumers accept a share of the risk and the liability if, when they purchase food, it has been labelled as containing GM material?
  (Dr Evans)  Our policy of course is to market products that are safe so in reality we do not believe that consumers think in that way and I certainly do not. Our policy is to make safe products and to ensure the excellent testing of those products. I can tell you, and I think it will not be disputed by many, that we have one of the world's best industrial toxicology laboratories based on decades of experience of course with agri-chemicals, and we also have one of the largest environmental laboratories in the United Kingdom. Our policy is to produce safe products which have passed all the regulatory hurdles, and that is our stance on this.