UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 248-i House of COMMONS MINUTES OF EVIDENCE TAKEN BEFORE ENVIRONMENT, FOOD AND RURAL AFFAIRS COMMITTEE TOXINS IN SHELLFISH SUB-COMMITTEE
Monday 19 January 2004 DR PETER HUNT, DR CLIVE ASKEW, DR GODFREY HOWARD, MR DAVID KERSHAW and MR ANDREW RATTLEY DR JOHN BELL and DR ANDREW WADGE Evidence heard in Public Questions 1 - 117
USE OF THE TRANSCRIPT
Oral Evidence Taken before the Environment, Food and Rural Affairs Committee, Toxins in Shellfish Sub-Committee, on Monday 19 January 2004 Members present Mr Austin Mitchell, in the Chair Ms Candy Atherton Mr Colin Breed Mr David Drew Alan Simpson ________________ Examination of Witnesses Witnesses: Dr Peter Hunt, Director, Dr Clive Askew, Assistant Director, and Dr Godfrey Howard, Shellfish Biologist, Shellfish Association of Great Britain; and Mr David Kershaw, Director, and Mr Andrew Rattley, Operations Manager, Kershaws Frozen Food, examined. Q1 Chairman: Gentlemen, welcome. The hilarity you heard from the Committee as you came in was not the scale of the audience, it is the fact that we have just discovered we are being televised, not for Mouse Vision but for the BBC committee programme. So, let me welcome and point that out to you. We have Dr Peter Hunt, the Director of the Shellfish Association of Great Britain and Dr Clive Askew, who is the Assistant Director; we also have Mr David Kershaw, the Director of Kershaw Frozen Foods, and Mr Andrew Rattley who is the Operations Manager of Kershaw Frozen Foods. We also have Dr Godfrey Howard from Aberdeen who was responsible for the previous series of tests done by the laboratory in Aberdeen; is that correct? Dr Howard: I was responsible for monitoring the level of toxins previously to 2000 when it split between England and Wales, and Scotland. Currently, I am here today as an adviser to the Shellfish Association. Q2 Chairman: I think this is a fascinating but fairly strictly defined inquiry and therefore, if we move at some speed, I hope you will forgive us. Can you tell us first of all what the current situation is regarding what the Food Standards Agency calls atypical DSP results and what you call in your evidence just atypical result. What is the present situation? Dr Hunt: The current situation is that, following the work that was done in the mid-summer which identified that various solvents and water from the cockle matrix was transferring across in the methodology, the Home Office identified that the levels were above those levels permitted and that would certainly cause the symptoms that had previously been identified and, as such, asked or demanded that such solvents be removed from the methodology. So, two major changes in methodology have occurred: one in June of this year and the final in November of this year. As a result of those changes which were designed to remove the solvent carryover, albeit not fully address the transfer of the matrix from the cockle, as far as we understand, there have been no atypical results since the tests were modified. It is very complex but essentially it indicates that, if a test is conducted properly, then these atypical occurrences do not happen. Q3 Chairman: Dr Askew, it is your contention from the evidence that, when the tests were transferred from Aberdeen to CEFAS, the methodology was different and there were a series of changes which, in your view, resulted in killing the mice and producing not only a mouse massacre but atypical results. What were those changes that were made? Dr Askew: Since we have had the two reports, particularly Professor Makin's report, we have become aware that there were actually five changes made. Three of those were admitted or were presented by the FSA. It does appear that those were moves towards the original Japanese method, which is known as the Yasumoto method. It does appear that previously Aberdeen had been using a method that was really quite divergent from Yasumoto's. The one adopted at Weymouth was closer in three respects: they increased the number of acetone extractions from one to two; the ether separation, the next stage, from two to three; and the other change was in the way the ether was extracted at the end of the process: Aberdeen had had an overnight stand. What was not immediately apparent and only became clear once we had looked at Professor Makin's report very closely was that two other changes took place. One was that, at Aberdeen, they carried out the extraction by a gentle swirling in a round-bottom flask. If you can liken it to a brandy glass and you have your two layers of liquid there and this is a very appropriate way to do it; you have to be careful not to create an emulsion. One of the changes at CEFAS was that they took from doing it in this round-bottom flask to do it in a conical shaped separating funnel, more akin to a champagne flute, and the only way of making the mix in that is by shaking from side to side and, in doing that, they risked creating emulsions. Q4 Chairman: It was shaken, not stirred! Dr Askew: Yes. I think it is maybe as simple as that. Also, in increasing the number of ether washes without increasing the volume of water at the final stage because the final stage is a water backwash to remove water-soluble compounds which are not supposed to be there, we have identified that, in the UK, we use by far the least volume of water of any country in Europe. We use five millilitres at each of those washes. If you look back in detail to the original Japanese method, he recommends that the volume of water should be the same as the weight of the sample which, for the 100 gram sample we are using, should be 100 millilitres of water. So, we are only using five. A lot of the time that may work but it means that our method is very, very sensitive to any slight errors and one shake too much of the hand --- Q5 Chairman: Is it your view that these changes were responsible for killing the mice? Dr Askew: I believe so and, in creating those emulsions, they carried over cockle juice, they carried over the water from the cockles, the water soluble compounds from cockles, many of which are likely to be toxic if injected into mice. Some of these are neuro-active substances. That does not mean that they are a human health risk. Q6 Chairman: Why do you only kill mice with cockles? Dr Askew: There is clearly a cockle factor; cockles are different in some way from other shellfish. Cockles are very sensitive when they are removed from the water. They do not survive well out of water. Cockles are fished and are cooked more or less immediately simply because, if cockles are out of water, they quickly gape and they quickly become stressed. Some of these water-soluble compounds which we believe are being carried over are actually stress substance; compounds are released by all animals when they are stressed; they are actually hormones in invertebrates. So, cockles are more stressed than other species when they are out of water. That is one likely cockle factor. There may be other differences which mean that cockles are more likely to create an emulsion, we do not know, but there is a cockle factor which has not been investigated. Page 42 of the Macauley report seems to be the answer to everything; they got that much right. Q7 Chairman: What does that say? Dr Askew: They put forward the hypothesis that solvents and water were being carried over together and they recommended that the extraction procedure be examined in detail and that has never been done. So, that is their own hypothesis and that has never been investigated. Q8 Chairman: Dr Howard, these changes were different to the procedures used in Aberdeen, which I assume did not stress the cockles as much. Dr Howard: Well, as I understand it, when CEFAS were awarded the FSA contract for the monitoring of algal toxins in England and Wales, they did change the methodology of the Yasumoto method but the Yasumoto method is a variable method, there is no precise recipe for it. There are slight variations anyway. What we are talking about here is a specific atypical DSP response in cockles. You get a normal, if I can call it that, DSP response in other shellfish such as mussels and you do get it in cockles as well. When DSP as we would define it under the terms of the directive containing okadaic acid and dinophysistoxins, known toxins, you get a typical response when the extract you have from this process is injected inter-peritoneally in mice. You get a typical response; you can examine the symptoms that the mice show and normally it is followed by death within two to five or six hours. That is the normal DSP response. What was being found here in these cockles was a so-called atypical response in which death was occurring very rapidly, within a few minutes, not at all typical of a normal DSP response but something that we had previously found in Aberdeen and specifically with cockles because, as Dr Askew was saying, the cockle matrix can produce these artefacts, but we had found it in Aberdeen and our predecessors, in Aberdeen, the Torre Research Station, which did some of the work as well prior to 1995, found this artefact in cockles and it was found to be a result of solvent carryover and this very rapid death is, according to veterinarians, typical of a central nervous system response to a solvent overdose. Q9 Chairman: Are you saying that the problem was known about in 1995 and that, in Aberdeen, the practices which produced this atypical result were avoided? Dr Askew: We worked to eliminate these, what we termed then, false positives, yes. Q10 Chairman: Let us move on. I have taken the first question but my colleagues are eager to come in on the consequences of this. The consequences of this were that grounds were closed. Mr Kershaw, you have given us evidence about the impact of this on the industry but Defra seem somewhat doubtful because their view is that most of the total allowable catch has in fact been taken despite the closures. So, how can you attribute a downturn in the industry to the closures which resulted from these atypical results? Mr Kershaw: First of all, the impact in Wales, where the beds were closed for 14 months - they were totally closed and only reopened after that - was that we lost a very, very good market in Spain which we had built up through attending exhibitions in Spain arranged with the DTI and Food from Britain. We were selling live cockles to Spain on a daily basis. We had six 40 foot articulated lorries, three on the road at any one time taking between 10, 15 and 20 tons of cockles from South Wales to Spain. That business started in April 2001 and, by August 2001, we had lost it. So, there was a main impact there as well as for all the other cockle producers in South Wales. The beds were closed. There was an impact also when the beds in South Wales were zoned. It is all very well having one of the zones open, for example, but, if the cockles are inferior or smaller cockles, then you get less price for them, you have more people working in smaller areas, so the stocks deplete and basically a worse cockle is produced, so your trade goes down. Q11 Chairman: What is the effect of the closure on the beds? We had some evidence that the dead cockles litter the beds and limit the productivity of the beds. What is the effect on the beds? Mr Kershaw: If you take too many cockles, you will strip the bed down. Mr Rattley: It is basically the same as an agricultural farm. If you do not continue to harvest beds correctly, the cockles, as they go through the year classes, will die and that has happened severely in the Burry Inlet and on the Thames Estuary as well as in the Wash. The older cockles are smothering the young juvenile cockles and killing them and that then chokes the beds. We probably will not see the true effects of that for another two to three years. Just expanding a little further on your original question to David, that Defra were under the impression that 91 per cent of the stocks were fishable. It has been very cleverly read from the Chief Fishery Officer's reports from the Thames Estuary and the Burry Inlet where it says that 91 per cent of the catch was achieved in the years 2001 and 2002. However, they very cleverly disguise the fact that it also states that the fishery officers were forced to change management opinion allowing the industry to fish on juvenile stocks to keep the industry alive rather than the true management structure of conserving stocks. Defra and the Food Standards Agency have very cleverly managed not to include that in the information that they forwarded to you and that is available through Defra's own sites. Q12 Chairman: So, the figures were spun? Mr Rattley: Yes. Q13 Chairman: What was the effect of the closure of beds in this country on imports? Mr Kershaw: We have been importing cockles from Holland in order to keep our English markets supplied. We supply supermarkets within the United Kingdom whereby we have to keep continuity of supply. All that has really resulted is that you replace one cockle with another. Q14 Chairman: Were the cockles coming in from Holland mouse tested in the same way? Mr Kershaw: No, they are not. Dr Hunt: They are certainly not tested in the same way. In fact, quite the converse. In Holland, the mouse test has been abandoned; they use an oral test of rats which does not kill the rats and, once that product is cleared by rat oral testing, that product has been free to come into the United Kingdom. If there ever was a toxin or anything that could have affected the cockles in the Wash, the Thames and the Burry Inlet simultaneously on the same day that the testing regime changed, then there is no doubt that it would have applied to Holland which is only 60 miles away. So, there is a total disparity in the regulations pertaining to imports. Of course, it must be remembered that 90 per cent of the cockles caught in this country are exported mainly to Spain. Q15 Chairman: So, export markets were lost? Mr Kershaw: Yes. I would like to add that, when the beds were closed in England and Wales because of the testing at CEFAS, some of the cockle beds were actually open in Scotland because the cockles were tested at FRS and the beds were open. So, we were allowed to take cockles from Scotland and sell them in England, which seemed a ludicrous notion. The impact on ourselves, taking the fact that we have been unable to fish, fish right sizes, and been pushed into areas where the cockles are just not fit to fish, it has resulted in my company closing down my centre in South Wales by December 2001. In December 2001, I closed my factor in Leigh on Sea and, in June 2003, this last year, I made a further 32 people redundant and closed down my shellfish operations in Southport, Merseyside, which had been in operation since my mother and father had started that in 1946. The impact on other processors have been similar. It is not just ourselves. My company has only been able to survive because we have a very successful business supplying supermarkets with other products/other frozen products, not just seafood, and we have been able to keep our cockle firm going purely by the money we have been able to earn from our other side of the company. With other processors, Rory Parsons, for example in particular, a very large processor in South Wales, has only been able to keep going because (a) he has been taking cockles from Holland and (b) he belongs to a larger Dutch group. We have found that only the larger producers have been able to stay in business purely because they are either owned by a larger group or, in my case, been able to be propped up by my other successful side of the business. Q16 Mr Drew: Can I just establish one thing before we go on to look at the arguments over the evidence for a new toxin and that is the degree to which this is a national problem or a European problem or is it a world problem, not that there are not different gradations in different parts of the world but I just think that we need a feel for how much this is really a United Kingdom problem. Dr Hunt: We did not have a problem until June 2001. Cockles were tested at Aberdeen and the tests had been adjusted such that it gave the right results so far. In actual fact, clearly there is a broader problem in that the European methodology for testing for these toxins is not satisfactory. That is the first point. That is why most countries in Europe and around the world have moved away from the European Union methodologies. Germany refuses to use it, Holland does not use it, Ireland has gone to LCMS. If we look around the world, New Zealand and Canada have moved away from the methodology because of falsehoods. However, that does not mean we can escape from the principal reason for this happening and that is the totally flawed methodology that was used after June 2001 that resulted in this. The mouse test has no status if it is not carried out properly. If the solvents and the matrix of the mouse which are wholly designed not to come across in this operation do come across, then it is totally invalidated and has no meaning whatsoever. So, even though there is a basic overriding problem about the methodology which is recognised worldwide and many countries have resolved it, essentially what we are talking about today is a flawed methodology problem. It is an interpretation. In our opinion, it is extremely poor science, a total lack of scientific objectivity in how it has been handled. Throughout, industry has invested an awful lot of money in consultancies in seeking advice from around the world and it has been totally ignored by the authorities. Right from the beginning, we recommended methodologies whereby we could get at least to distinguish whether it is a procedural or an artefactual or something that is just affecting mice or something that could affect humans and that was totally ignored. The reason for that was that it had gone on for a year before it really became acknowledged that the problem existed as it did, by which time it seemed that the authorities were embedded in their own vision and were not in a position to turn around. Q17 Mr Drew: Can I move on to look at the evidence for a new toxin. What level of discussion was there in advance of this change in policy with the industry in terms of looking at a new research approach? Obviously, the centres where this research was being carried out, the testing and so on, was altered. Were you fully au fait with what was going on or did this come as a complete bolt out of the blue? Dr Hunt: We certainly were not fully au fait with what was going on. We had put through our proposals as to what we thought should be done, but that was substantially ignored, albeit the work that was done could not camouflage the results that eventually did come out and they clearly showed that there was a multiple solvent carryover and carryover from the cockle matrix. We believe a combination of those things is resulting. I think there is a totally different approach to that which is taken by other countries. For instance, samples taken around the British Isles are put in a little polythene bag in a little polythene box and put in the post. These animals are very sensitive; they are the most delicate of mollusc and shellfish and the New Zealand authorities have totally modified it to make sure that the temperature never goes above ten degrees and that the cockles are in a good condition when they arrive, a totally different approach. As to the research that has been done to identify the actual toxin itself, we were asking from day one from the first meeting on 15 January 2003 with Sir John Krebs, to be involved in the drawing up of such research proposals and to be involved in what experimentation was to be done. We were told on 23 December some detail of the research that was being done to identify the toxin. This was fully nine or ten months after we should have been told and, when we looked at what was being done, they have a clear methodological problem there in that the basis for the research that is being done is certainly not scientific, it is unsound, and we have yet to go back substantively on that issue to them because, as I say, we received it on 23 December. Q18 Mr Drew: So, can I be absolutely clear that all five of you are ruling out the notion that there is a new toxin because you believe that there is no scientific rationale to support that proposition as advanced by the FSA? Dr Hunt: Absolutely. Dr Askew: At this moment in time, there is no evidence whatsoever. I have said that in my written report. At this moment in time, there is simply no evidence for it. Q19 Mr Drew: That is on the record. Presumably relationships with the FSA, notwithstanding the argument over the research disagreement, cannot be very good at the moment. In what way are you trying to rebuild a relationship whereby there is some attempt to come to an agreed position on the science or are things completely broken down? Mr Kershaw: I think it is impossible when they have ignored the science that we presented to them. We have employed and paid for a lot of scientific advisers. We have simply said to them, "Find the toxin. Find out what the problem is." All those reports which are mentioned in our submissions point to the fact that it is not a toxin. Yet, when we present this to the FSA, they totally ignore us. When we have attempted to work with our local EHAs, we have been blocked at every turn. So, we feel that the atmosphere has never been really there from the FSA for us to ever work with them. They have taken a very highhanded approach to us and we feel that we are getting nowhere. They told us as early as December 2001 that they had found a new toxin. Since that date, in two-and-a-half years, they have never presented to us any evidence that they have found the toxin, yet we have produced over and over again evidence, which we presented here and we can present more evidence if you wish it, that it is a matrix cockle mush, whatever it is, of solvent carryover and they have ignored it at every turn. Yet we have said to them, "If it is a toxin, show us, please." Dr Askew: About a year ago, we thought we were working very closely with the FSA. Our own consultant drew up a very detailed schedule and operating procedures specifically to identify the problem, to identify whether or not there was a toxin problem and to eliminate everything that was not causing a problem. This was very, very detailed: I think it was a 16-lay matrix. This was to be carried out at oral testing with rats. It was agreed when the FSA came to Fishmongers Hall to the Association in May of last year that, if there were any problems with Home Office approval in the UK, we could get it done in Holland. We approach the Dutch national laboratory and they agreed they would do it. The FSA said that they were not then happy with the end points used for experiments in Holland and we went back to Holland and the laboratory there agreed that they would carry out rat oral testing to any protocol which the FSA chose. So, that piece of work could have been put together very, very quickly at that moment in time. Since then, relationships have really deteriorated. There have not been constructive relationships since that time. Q20 Mr Drew: Has there been a legal challenge advanced by the industry and does that also relate to the decision of the FSA, according to the precautionary principle, to actually shut down the beds? Where are we in the legalities of this? Dr Hunt: I am not involved in any legal action but certainly Kershaws are proposing to take legal action and that has been deferred pending this inquiry. There is no doubt that we are looking or industry is looking for a route whereby it can finally get this matter resolved. Q21 Mr Drew: So, there is no current legal action, not even in terms of the beds? Presumably, you voluntarily chose not to carry on? Mr Kershaw: Yes. It has never been our intent from the beginning. We have tried and attempted in every way to sort this out and put some commonsense into this whole mess, but it is a final, final resort by us. Mr Rattley: With the fact that we have put on hold the legal challenge, currently all of the cockle beds are open. Amazingly, just going back on where you asked if we could rebuild relationships with the Food Standards Agency, it is very difficult to rebuild a relationship when they have totally ignored the multiple solvent carryovers and will not admit that their methodology is flawed. It begs the question that, since 17 November, when they changed the methodology within the laboratories again, there have been no atypical responses whatsoever. So, it just begs that question. How, if there has been a methodology change and there have been no atypical responses since that date, can they still say that there is an unknown toxin within when it points clearly to what all of our scientific advisers have said, that it was methodology in the first place including multiple solvents? Q22 Mr Drew: What discussions have you had with the FSA in terms of presumably their main concern which is the impact on human health? Is there any evidence at all that human beings have been affected by what they have eaten, not necessarily in this country but internationally, which caused the FSA to enact the precautionary principle? Dr Askew: Since the problem began in June 2001, we have had a large number of closures. It did occur to me to sit down and try to extract how many new closures there had been. When I say "new closures", ones that were not preceded by previous weeks' closures. Each of those closures should have been accompanied by a product recall because in fact the cockles are normally collected on a Monday and the results are available on a Thursday or Friday. So, you have normally the best part of a week's product going on to the market. So, something like 50 per cent, possibly, of cockles harvested have actually gone on to the market prior to this testing procedure. I think there have only been one or two product recalls. If the FSA believed in this toxin, they would certainly, on a precautionary principle, carry out product recalls. There is no evidence of illness throughout that time. Q23 Mr Breed: Perhaps I could move on to the whole area of the evidence of the methodological flaws which is at the heart of all this in a way. You have made it quite clear that you believe that there was very poor scientific methodology in this and that is why we had the atypical results. CEFAS says that they used the same method in other shellfish and that does not give lots of atypical results. So, there must be something clearly very specific about cockles. You said that it was perhaps to do with the way in which they carry out the test or the way that the cockle is looked after because it is very delicate and that sort of thing. Is that the principle area of dispute in terms of the evidence for this methodological flaw or is there other clear evidence that you would present to say that the way CEFAS carries out the tests or rather the way in which it administers the tests is flawed? Dr Askew: In my written evidence, I have provided a table where I have tried to simplify it showing the differences between the methods used in Great Britain and the original method. The directives that we all operate to requires us to operate to a customary bioassay. I believe that the word "customary" has to mean something. It seems to have been completely ignored. The word "customary" must mean something. There are two aspects of that. Firstly, it is the question of which version of the original test was the customary method and I have presented in my annex the method published by the International Oceanographic Commission which is Yasumoto's method but it actually gives more detail than the paper nominally referred to as "Yasumoto 1984." So, that shows how divergent we are and particularly in regard to this volume of water which is used at the last stage and, if we have that table to hand, you will see that we are anything up to 20-fold too small in the quantity of water we use at that final backwash stage. I would argue that the methods - and this goes for all the methods used in the UK - are not the customary method. The other aspect of that word "customary" is that it must presumably restrict the extent to which laboratories can undertake new bioassays, to which they can modify bioassays, and what happened here was clearly that CEFAS and DARD in Northern Ireland developed their own versions. We know that, certainly in the case of Northern Ireland, the version that has finally been more or less adopted as the national standard was developed even without reference to the original International Oceanographic commissioned work. So, they have started to use a new method. We maintain that that is not the "customary" method. So, the UK today is not using a customary method as required by the directive. Q24 Mr Breed: So, the evidence revolves around what is customary and what they have been using, two different ways of tackling it, producing therefore, you would say, different results. Dr Askew: Yes. Q25 Mr Breed: What is your response to CEFAS's suggestion that atypical results are found more often by the CEFAS and DARD laboratories than FRS because the protocols that they have used in those labs might be more sensitive? That is their counter to your view. Dr Askew: I have thought a lot about this. I think that possibly when CEFAS made their changes, when they modified the method, when they took responsibility for it, three of those changes were moved towards the original Yasumoto method. They increased the number of acetone and ether extractions. They saw those as making it more sensitive. At the same time, they happened to make these other changes which Professor Makin's report has made clear. Professor Makin more or less refers to it on page 26 where he refers to the rather vigorous shaking carried out at CEFAS Weymouth. He suggests himself that that is what was taking place. When we look at page 42 of the Macauley report, they hypothesise the same thing. When I first read this and put them together, I could not believe that scientists like this would not have realised what was happening. In fact, in only recent days it has occurred to me that actually the Macauley Institute at that time would not have had access to Professor Makin's report, so they would not have seen Professor Makin's report at Weymouth and dirty extract at Weymouth. Likewise, presumably Professor Makin would not have seen the Macauley Institute's hypothesis that the water and solvents were being carried over together. Once you have those two things together, it is really quite clear what is happening: they are producing an emulsion; once you have little spheres in emulsion - it is like vinaigrette dressing - there are no amount of statistics --- Q26 Chairman: So, it is not in fact sensitivity, it is crudity. Dr Askew: You are then injecting cockle juice into mice. Q27 Mr Breed: So, it is nothing to do with sensitivity at all in terms of the methodology. So, what is the response when you say that the same methods are used in other shellfish without producing substantial numbers of atypical results? What is so special therefore about a cockle? Dr Askew: We know that cockles are more stressed. Q28 Mr Breed: And that is all? Dr Askew: Yes and there may be something in cockles which makes them more liable to form emulsions. The Macauley Institute's recommendation on page 42 was that the extraction method is to be investigated in detail - that is what the Macauley Institute was advising them to do. Q29 Mr Breed: And they have not done it as yet? Dr Askew: No, not that. Q30 Ms Atherton: We have talked about mice, we have talked about cockles and I want to talk about CIVITs, namely the Cockle Industry Initiative on Toxin Testing, and I think the acronym of CIVIT is much more helpful. Can you tell us how your proposal would actually improve matters. Mr Rattley: With regard to CIVIT, it is an industry initiative for the testing for toxins within shellfish. It does not purely cover the cockle shellfish, it will cover the whole range of shellfish. We produced, along with our scientific advisers, our proposals back in October of last year. That was submitted to the Food Standards Agency on 13 November for them to peer review and place comments along with the local enforcement officers and, as of today, we have still not received any response from the Food Standards Agency and we are led to believe from the environmental health officers that they are not in a position to actually give us a response to CIVIT because they have to take advice from the Food Standards Agency. CIVIT will give a far greater consumer protection than is currently in place in the UK with the MBA. It has been designed to grow as science grows. LCMS can be incorporated along with the other biological assays that are incorporated in it. It would be a quantitative test whereas the MBA is not quantitative. What we did suggest to the Food Standards Agency is that they should run both systems because where the MBA has been known to give false negatives as well as false positives throughout its history, Ireland and New Zealand have looked at using other methods which have given them a quantitative decision as to whether to close beds or not and run the mouse bioassay in background screening, which is what it was originally designed for, it was never designed for routine monitoring. The European Commission decision does allow for LCMS and other assays. The Food Standards Agency have taken it in their interpretation that the mouse bioassay is the only method to be used and, yes, it comes down to which way you read it and interpret it because, if you are in France, you interpret it in one way, in Italy another way and, certainly in the United Kingdom, the Food Standards Agency way. The CIVIT document does not give rise to full methodology. It gives rise to quantitative measures throughout and it is very difficult to actually go through the whole of our document without one of our scientists actually presenting it for you. Given the overall benefits, it would give a far greater consumer protection that the Food Standards Agency currently offer. Q31 Ms Atherton: I can see where you are coming from but would you not agree that, if you had the two regimes running side by side, one the statutory one and then your voluntary one, it is even more of a recipe for argument and dispute? Mr Rattley: That is debatable because, at the moment, Ireland use the MBA for background screening and the assays and the LCMS for the main monitoring. If they then have a problem, they will refer back to the mouse bioassay. That is what we have asked with the Food Standards Agency. If the CIVIT is proposed and used for normal routine monitoring and you then get a blip where it shows that you have quantitative okadaic acid or one of the other groups, the mouse bioassay can be run in conjunction and it would give a true picture whereas the mouse bioassay is a crude test that does not quantify what any of the toxins are. Q32 Ms Atherton: Can they screen for unknown toxins? Are they as reliable? That is what the public are going to ask, is it not? That is the lynchpin question. Are the public going to buy this? Dr Howard: Perhaps I can come in here. There is an onus on the industry to conduct what is called end product standard tests. The Food Standards Agency, through its various laboratories under the EU and national legislation, run the required statutory monitoring screen but there is also an onus on the producers of shellfish to do what is called an end product standard test. Now, this is extremely difficult for them at the moment with sole reliance on the mouse bioassay because there are relatively few laboratories in the country that are licensed to do that sort of test. So, a chemical assay would be much more advantageous to the industry. In answer to your question, yes, there are in the main now standards that would allow an LCMS or an HPLC analysis to be carried out on most known toxins. If there were an unknown toxin that came in, you would be likely to get an unidentifiable peak in the analysis trace from which, although you would not know what it was, you could hypothesise that there was a toxin there and then act on the precautionary principle. Q33 Chairman: What range of tests are available? I take it that there is mouse testing, there is chemical testing and there is chromatography. Dr Howard: There is a mouse bioassay and there are various different chemical tests. The main ones used in toxin analysis would be HPLC, high performance liquid chromatography, which is currently used as the required test for one shellfish toxin, ASP, amnesic shellfish poisoning. It can be used and so can LCMS, liquid chromatography mass spectrometry. They can both be used to identify the DSP toxin group, okadaic acid and the others. There is also what is called a missed kit, a missed alert kit, which is produced by an American company which can identify PSP, paralytic shellfish poison toxins. So, there are ways to certainly reduce the requirements on the mouse test. Q34 Chairman: And these are all permitted under EU regulations? Dr Howard: These would be permitted. Mr Kershaw: The mouse test does not test for all unknown toxins and, if you wish to have further clarification from any scientific person, then we are more than willing to supply that information to you. The mouse test does not test for all unknown toxins. Mr Rattley: You asked, would it give confusion? I think we have to look at it in two ways. The New Zealand food authorities only use the chemical methods now and we allow food imported into this country, particularly the mussels, from New Zealand without them going through a further mouse bioassay. Surely, if the Food Standards Agency had that much doubt that there was a risk to public health, they would not allow the product into this country. Q35 Alan Simpson: Although food authorities are the third party in this relationship, it is quite clear that the major part of this relationship is between yourselves and the FSA. Just reading through some of your comments, they are pretty robust comments, that the precautionary principle has been misapplied, that the Agency now believes its own spin, it seeks to camouflage extremely poor science, it is paranoid about the release of information. I think if we were in a RELATE session, we might take the view that we have reached the stage where we were arguing about who had the fridge and who had the CD player. Is there any basis of a working relationship between yourselves and the FSA at the moment? Dr Hunt: Of course there has to be and we wish there to be. We are seeking one single thing and that is security of our product. We have, it is relatively small, probably around a £20 million industry, principally export, and we are seeking only to protect that industry. Of course, we would welcome the opportunity to work with the Food Standards Agency. The attitudes that have been put to us have been quite insulting at times where we have had quite complex meetings and the minutes that come out sometimes do not reflect the discussions that we have had. The meeting that we had in January 2003, we thought we had moved a long way in getting towards a solution and then it all stopped and it just was not continued. Under the precautionary principle, there has to be some proportionality to risk. There has to be. Really, none has been identified at all. There is no chemical identification of any toxin, there is no clear policy of product recall, there has been no illness, there has been just no evidence. Also, any such precautionary approach has to be non-discriminatory. Certainly we are discriminating against UK producers versus other European producers because they have free access to our market. We are actually discriminating between England and Scottish producers. Scottish cockles are not subjected to this test and of course can place the product on the market and the English producers cannot. There is also an obligation to produce cost benefit analysis, which has to be continually applied. The cost of this has grown. There has to be some sort of cost benefit now to see where this risk or supposed risk is. What is the value of it? What is it doing? The decisions that have been taken have to be reviewed and they are not being reviewed. The industry has not been involved in those discussions. When we first started on this, if we had followed the empirical approach to identification of essentially whether it was a procedural, an artefactual, a response purely in mice or a human response, it would have taken, we estimate, six weeks for any reputable drug company to do that and it would have been finished in mid-February 2003. I am not of the school of which some of my side are where some people in the industry believe that it is right to withdraw a product immediately in June 2001. I believe that with such testing, when it is transferred from one laboratory to another and then suddenly all the results change, there is an obligation to check that the methodology being used is correct and that was never done. In fact, for the first six months, it was totally camouflaged; it was called a true DSP and, for six months, we believed it was proper DSP. The industry cannot afford to have true DSPs. We lose the business completely if we are going into real toxins. For six months it was declared as real DSP and then it was admitted that it was this very rapid CNS reaction. All along, right from July 2001, the Food Standards Agency and CEFAS were being advised that this was a solvent problem, because it has applied all around the world. Everyone has had the problem since the famous Torre Institute that was closed down in 1995 picked this up in 1990. If you read the protocol in Italy, it specifies exactly how you get round it. In June 2003, the New Zealand Government Authority sent to the Food Standards Agencies what they did, how they dried up the final extract to ensure that there was no solvent in the final product that was injected into the mice. It has all been on the table. Q36 Alan Simpson: Have we learned anything out of this? Dr Hunt: We have learned what it took Ireland a long time to learn. Exactly the same situation arose in Ireland some four years ago. In Ireland, their Food Standards Agency took a similar approach. It was a battle. As soon as industry got together with the Food Standards Agency here they established committees that worked closely together on the risk of each individual case of any positive result. They solved the problem. They have had no closures in Ireland since. It was forced upon the Irish Food Standards Agency by politicians and that is why we are hopeful that, by coming here, somebody can force them to work together with us to solve the problem. Q37 Alan Simpson: Would you accept that the food authorities were the minor, third part of this relationship and they are perhaps the kids in the equation? Some of their submissions have been saying that the industry itself has also been pretty poor at sharing information. Would you accept that there is any validity in that? Dr Hunt: Absolutely not, no. We called a meeting on 15 October, where we wished to present to everybody what our consultants had prepared for peer review. All the environmental health authorities came and the Food Standards Agency en bloc refused to come saying it was not possible because of other engagements, but there was more than a month's notice of that meeting. Q38 Alan Simpson: Carmarthenshire County Council have said that the shellfish industry received information which would have benefited local authorities; yet it was not shared. They go on to be equally critical of the FSA, but it is very easy to 100 per cent this and I was wondering whether the industry accepted that there were any down sides in its role in sharing information with food authorities. Dr Hunt: I do not think there is, except that of course none of us is a great expert. All of us are feeling our way through what is a very difficult problem. We have had to invest an awful lot of money into trying to find out the answers. Even at the end of it, we cannot see how we have such a different view to other people. Q39 Alan Simpson: In terms of the lessons to be learned, your view is that the whole industry, the sales and the FSA, has to be made by politicians to work together? Dr Hunt: Yes. Q40 Alan Simpson: That is the bottom line and why we are all sitting here? Dr Hunt: We do feel that the science has to be properly investigated. We believe that in some areas it is so poor that it justifies an investigation by the Office of Science and Technology. We will be recommending that. We believe that industry has been treated very poorly and should be compensated fully. Q41 Chairman: You want compensation? Dr Hunt: We do indeed. We believe there is only one single body which thinks the way it does. This problem has been bandied around the world. Everyone is interested in it and we have not met any other government or anyone else who has had the same problem and not resolved it, certainly not the way we are going. Q42 Chairman: Thank you. The evidence you have given us is very powerful and interesting. I end the session with you by saying that if there is anything else you want to add please drop us a note as quickly as possible because we hope for a fairly quick report. Alan said it was like Relate marriage guidance counselling. It would be fairly difficult if it were. Dr Hunt, could you sit at the front and if there is anything you want us to put or you think we are ignoring when we come to the Food Standards Agency wave a note and my colleague will fetch it over. That is a fairly unusual situation but it is frustrating for a Committee like this where we hear one set of evidence and another set and there might be grounds for bringing people together in a Relate fashion or for putting issues that we are dealing with inadequately from the Committee point of view. Mr Kershaw: After this session, if there are any further details you require, will you be calling us back, writing to us or what? Chairman: I will ask the clerk to have a word after the meeting. Thank you very much.
Examination of Witnesses Witnesses: Dr Jon Bell, Chief Executive, and Dr Andrew Wadge, Director of Food Safety Policy, Food Standards Agency, examined. Chairman: Welcome to the Committee. You have heard the industry side of the story. We want now to explore the Food Standards Agency's side of this argument, which I must say is fascinating for us to hear about. Q43 Mr Drew: Can we start with the science because obviously where the breakdown in relationship comes from is on a scientific rationale. I think it would be useful if someone could say when you first suspected there was a problem, why you acted in the way you did and how the science that you believe is in place backs up the actions that you have taken. Dr Bell: The problem first came to our attention as the laboratories in Northern Ireland and CEFAS began to see these unusual reactions in the mice that they were using for their standard DSP test. The mice tended to get into distress and die in a number of cases very much quicker than had been traditionally observed when using that type of test. This seemed to point to some possible new phenomenon which had to be taken seriously as it might point to the emergence of a new toxin. Q44 Mr Drew: What is the hypothesis which you believe to be the case which is showing that there are these atypical reactions? Dr Bell: The difficulty is that we have no firm hypothesis on what is causing this. Using the definitive test that is laid down in EU law, where there is any doubt between the various tests that are available, we are seeing reactions which suggest the possibility of a toxin. There can be other possible explanations as well but the difficulty at this stage is that we cannot rule out anything, including the fact that it may be a toxin. Q45 Alan Simpson: It sounds a bit like bovine TB to me but we will not go along that path. This Committee spent long enough on that. Are you absolutely convinced that there is a novel toxin in existence? Dr Bell: No. We do not know. Q46 Chairman: Were you then convinced there was a novel toxin? Dr Bell: No. We have never been convinced it is a novel toxin because we have never had the definitive evidence that one would need to say that it was. Q47 Chairman: Did you think it was a new toxin at the time? Dr Bell: We thought it was a possibility. We took advice from Professor Yasumoto and from Canadian experts. They had seen a range of various toxins over the years. We described the position to Professor Yasumoto and we sent him an extract. He reproduced in his own laboratory the same reaction with mice. We sent a video of the mice to the Canadian experts and they both said, "This looks like a neurotoxin." Q48 Mr Drew: Can I be clear about what determined the sequence of actions? You persuaded the industry that it needed to shut down its beds? Dr Bell: No. Q49 Mr Drew: Can you take me through it? I am very unclear what actions you took. Dr Bell: We are required to take certain actions under EU law if we believe that there is a potential threat to human health arising from shellfish. The test gives you certain results and you are required to take those as positive or negative. Once one gets what are classed as positive results - and this looked like a very firm positive, but in unusual circumstances; it certainly fitted the requirements for positive in that which was laid down - we can then communicate that with the local authorities whose job it is to take action locally to protect human health. That is the sequence. That is their decision but obviously it would be difficult to make any other decision than the one that they have customarily made to close the beds until such times as negatives start coming through on repeat tests. Q50 Mr Drew: What is the overall picture in terms of people being poisoned by eating shellfish? Is this a common problem? Dr Bell: No. Thankfully, it is a very uncommon problem. We have had very little of it in this country over the years but there have been some very marked outbreaks in some other countries. As a result of the toxin that the Irish discovered in recent times, there was a number of people made quite ill and the Canadians had a very severe outbreak a few years ago. It is certainly a possibility. You could argue that the reason we have not had it in this country is because we have been very careful about how we have operated the protection regime that we have, but I cannot be certain of that one way or another. We certainly have not experienced thankfully what others have experienced in this area. Q51 Mr Drew: In terms of the evidence of the previous people, we could be importing this material from the Netherlands. If there was an incident of poisoning, we could act but we could not take a precautionary principle stand against those importing. Dr Bell: Unfortunately, the position is difficult in that regard because we are working within the Community on this, as you know, and the rules supposedly apply across the whole Community in an even handed way. The position we have taken on this is that we want to protect human health of course. That has to be our primary role but we also want to be proportionate in the way that we are doing this, as far as we are able. We have taken the view that these sorts of issues can have chronic effects as well as acute effects and small amounts over a short period of time are not likely to be the issue here. It is likely to be longer term effects over an extended period of time. Provided one acts reasonably swiftly on closing beds and provided we are not talking about similar problems elsewhere that would involve consumption of large quantities, we think we have the proportionality principle about right. It is a matter of judgment. Q52 Mr Drew: What is the minimum period of time that you think you have to enact the precautionary principle? Dr Bell: Usually, we try to do all the testing from the collection through to the testing within one week, with the collection and the despatch occurring in the early part of the week from Monday onwards, arriving at the laboratories by Wednesday and results by Friday, temporary prohibition orders being put on at that time if necessary. Q53 Mr Drew: How do you respond to the view that the industry has advanced that may result in legal action - we hope not - that you do not have the powers to impose closure, notwithstanding you do not do that, but you are making a strong recommendation? Do you feel confident you have the powers? Dr Bell: The legal powers are most certainly there. Further than that, we are required to act in a certain way as laid down by EU law. You do the test. If you get what is classed as a positive and therefore there is a concern that there may be an effect on human health, you are required to take the necessary steps to ensure that you control that risk and that means closure of beds. Q54 Chairman: There was a change in the laboratory doing it from Aberdeen to CEFAS. Why was that? Was it as a result of a competitive bid? Dr Bell: Yes. It was two fold. Firstly, we had a visit from the Food and Veterinary Office in 1999 to look at the way we were applying the EU regulations and they made a number of criticisms, the principal one of which was that we were not doing enough sampling, by a long way in their view. The levels needed to be stepped up considerably. Q55 Chairman: Who visited you? Dr Bell: The Food and Veterinary Office is the European policeman, if you like. They are the European local authority. They check that you are applying the law in the correct way and they report their findings back to the Commission and the Commission could at the extreme take you to the European Court. Q56 Chairman: They put the fear of God into you? Dr Bell: They are obviously a very powerful body and one takes careful note of what they say. You do not always accept everything they say but in this case they said that they thought that the extent and the timing of the collection and testing of samples were not adequate to cover the risk. Q57 Chairman: That is not an argument about the methodology, is it? Dr Bell: This was nothing about the methodology. This was to do with how frequently and how much sampling and testing were being carried out. We took the view that we should increase the amount of testing and that it was not at a very high level at that time. It became appropriate also, since there had never been any competitive tendering and these are fairly large contracts, to put the work out generally for tendering. Q58 Chairman: This was a cheaper bid? Dr Bell: No, not necessarily. It was judged against a whole range of criteria by an independent group. Q59 Chairman: Was it cheaper? Dr Bell: I cannot say. That certainly was not the deciding factor. It was to do with their ability to deliver and the timeliness. Q60 Chairman: In asking people to frame bids, did you set out a standard operating procedure for what they should do? Dr Bell: Not in the way that we now talk about the standard operating procedure. Certainly it was made clear what was required. It had to be done in line with EU legislation and that meant effectively following the Yasumoto approach. That was understood. Q61 Chairman: You had a competitive bid. In comes this bid from CEFAS. They start doing the tests. It is argued in a different way to the way it had been done in Aberdeen and all of a sudden you find yourself massacring mice. Did a bell not ring that it could have been due to a change in the lab, a change in the methodology or the climate? Dr Bell: The story is not quite as straightforward as that. You might well have drawn that sort of conclusion, quite rightly, if it had been straightforward. Although there was a change in England and Wales as to who was doing the testing, there was not a change in Northern Ireland. The Northern Ireland testing had always been done for very many years by the Department of Agriculture's laboratory there and they carried on doing it. They started to get exactly the same results at about the same time. Q62 Chairman: Did they change their methods? Dr Bell: They did not. They had been operating at that time for a while, certainly some time, using the mouse test and they began to see quite independently much the same sort of results. Q63 Chairman: There was no change in Scotland. Dr Bell: No. They were using a rather different approach in Scotland. You have heard some of the detail of that in terms of the amount of extractions they were doing, over what period and whether they stood their extractions overnight. There were some differences in the way that they were doing the work. There is no real evidence for this one way or another but you could argue they might not have been as vigorous in the extraction of material. That is a possible interpretation. I am not saying it is the only one. We were not clear why these differences should appear. Q64 Chairman: At what stage did you begin to think, "This is not a new toxin", a killer toxin or whatever; "This is a change in the way it is done"? Dr Bell: We never thought that. We never have thought that. We took the view that we did not know what was causing this effect. We still do not know clearly what is causing this effect. What we had to ask ourselves was: "Are we certain this is not a new toxin?" If we are certain of that, we can proceed as normal but if we think that one possible explanation here is a new toxin and we cannot rule it out what position should we take in terms of protecting human health? We were very mindful of the lessons that have been learned since the days of BSE about what one does in the face of uncertainty in a situation and that is that you take reasonable precautionary action to ensure that you do not learn after the event that it might have been a toxin. Q65 Alan Simpson: When you talk about not knowing what caused the effect, is it correct that when you changed the procedures, since doing that, there has not been an effect? Dr Bell: There have been no atypical results in the last two or three months. When we plotted out what had been happening previously, it is clear that there had been a drop in the number found before the changes were made. One could not necessarily draw the conclusion that it was as a result of making further changes to the methodology that it has now dropped down effectively to zero. Two positives were found immediately after CEFAS made the changes and then it dropped away after that. Positives were being found in Northern Ireland consistently because it was effectively their methodology that was transferred across to CEFAS and the Aberdeen laboratory with some changes. Q66 Chairman: You were taking reassurance from Northern Ireland but Northern Ireland changed from feeding it to rats in 2000 to using the mouse tests. They did not have the experience that the Aberdeen laboratory had in using mice, so you were both going down the same track. Dr Bell: That is true, but they had been doing it some while before these atypical results started to turn up. You would think, if it was their inexperience with the methodology, you would see it almost immediately that they moved away from the rat and that was not the case. The other factor we have to take account of here is that not every cockle result turns up positive. Far from it. A good 60 per cent over the three years we are talking about have turned out negative. Q67 Chairman: You have just said to us you did not think and you do not think now it is the methodology. Dr Bell: We do not say that at all. We are not clear what it is. Q68 Chairman: You must have been suspicious because you then commissioned studies of the methodology. Dr Bell: We have been looking at all the facets of it, which is what you would expect us to do. If we had been clear it was a toxin and we had good evidence for that, it would not have been necessary to have done anything else on that, except perhaps to try to characterise what that toxin was. Because we were not clear and there was a range of possible explanations, we thought it necessary to do work right across the spectrum. We have done quite a lot of work looking at the methodology and we are doing some toxicological work to look at the possible threat to human health as well. We are under way with that now. Q69 Chairman: Somebody said tests are done on Monday and Tuesday and you have the results by Thursday or Friday. By that stage a lot of the stuff can have been eaten, can it not? Dr Bell: Yes. We are trying to work in the most realistic way we can. We are trying to be as proportionate as we can. Our main concern here with toxins of this type is about consistent consumption over a period. We took the view - you may say it was a wrong view to take - that consumption over a period of a few days would not be an issue in itself and we should act as soon as we definitely had positive results that we felt we could act on. Q70 Chairman: You had positive results and people did not die or fall ill. Dr Bell: No, they have not, so perhaps we are not looking at an acute effect here. The difficulty with all this is that these toxins do not only manifest themselves in that way. We have had discussions with Professor Yasumoto and he has been able to produce evidence that shows that some animals on which he has done toxicological studies appear healthy until he opens them up. Q71 Mr Breed: Can we look at the way in which differing laboratories came up with differing results, differently interpreted by different people? Why was there no standard operating procedure put in place right at the beginning so that at least there was some comparability between the laboratories involved? Dr Bell: I take the point. With hindsight, we should have taken steps to do that. This general shellfish testing has a long history and it had never been considered necessary to do it up to then. As long as you followed the Yasumoto approach - and there were variations that scientists made around the general core of that approach - nobody thought it necessary to have an absolutely standardised method in every regard. That had never been negotiated and agreed in Brussels. As far as I know, no Member State had taken any action to do that. Once we got into this position, it became very clear very quickly that we needed to do some standardisation because obviously laboratories testing within the UK around the same waters who should, one would presume, have been obtaining the same sorts of results, had variation. Q72 Mr Breed: In the bid process, there was no laid down procedure that you required of them in order to fulfil the contract for the testing? They could do what they liked? Dr Bell: No, not to that extent, not fine detail laid down, as every step would be laid down as you would in the standard operating procedure, but making it quite clear that the procedure had to follow the EU requirements which are the Yasumoto method. Q73 Mr Breed: That is then; this is now. Do all laboratories now operate under an SOP? Dr Bell: Yes. Q74 Mr Breed: Which was laid down by? Dr Bell: We drew the laboratories together following Hugh Makin's report where he had found discrepancies between the various laboratories he thought ought to be addressed. He did not consider these materially affected the results but nevertheless he thought it sensible that we should take action to tighten these up so that is what we did. We called a meeting of the laboratories together and we collectively agreed that the methodology which should be followed would be the Northern Ireland methodology with some small tweaks. Q75 Mr Breed: The Northern Ireland one is now being carried out in the other two laboratories? Dr Bell: Yes. Q76 Mr Breed: What effect has that had on the test results? Dr Bell: At the moment we are in this period - long may it last - where we are not getting positives. Q77 Mr Breed: From anyone? Dr Bell: From anyone. Whether that is as a result of the change to the standard operating procedure or whether it just happens that we have fallen into a period when the problem has gone away for the time being, it is not possible to say. We have looked at what was happening immediately before this and sure enough the number of positives was falling away anyway before we made this change. We do not feel confident that we can make the decision, at this stage anyway, on only a few months of negatives. Either the toxin has gone away or the change in the methodology resulted in the change. Q78 Mr Breed: If everything carries on as it is at the moment, when would you expect to be able to say that everything is okay? Dr Bell: The principal thing we have to do is to complete the toxicology. If this toxicology comes out negative, I think we will be pretty confident that we do not have a threat to human health here and that is assuming that the toxicological experts on the independent committees agree with that. Then we will be fairly confident that whatever the background to this was there was not a threat to human health and we can take action accordingly. Q79 Ms Atherton: You appointed Professor Hugh Makin to come in and independently audit the testing. What was your response to Dr Askew's assertion from the Shellfish Association that Professor Makin could not say that ether did not cause the atypical results? Dr Bell: Professor Makin did say quite clearly in his report he did not consider the carry over of solvent was giving rise to the observed results. That was his professional view. Obviously, one combines that with other information but we did not take that as an absolute, definitive answer to that and we have done quite a lot of work since to make sure that solvent levels are kept absolutely as low as possible. Q80 Ms Atherton: Earlier we heard a suggestion that the transportation issues in this country are very different perhaps to New Zealand. What is your reaction to that? Do you think that might have been a contributory factor and have you taken that into account? Dr Bell: I do not know whether that is a contributory factor. I am not sure that we have done any particular work on that. The National Reference Laboratory lays down the requirements for transportation and the way that the samples should be treated on receipt. One would hope that they have taken account of that but I cannot answer that definitively at this time. Q81 Ms Atherton: You talked a little bit about testing the methodology. Can you tell us a little more about how you reacted and what your response was to the Shellfish Association's suggestion that poor scientific methodology at CEFAS is responsible for the atypical results? Dr Bell: We considered it very carefully. We could not see any immediate grounds for that. Although the shellfish interests said that they considered that solvent carry over was a serious problem, working off what Professor Yasumoto informed us when he reproduced the results himself in his own laboratory, the fact that he came over and witnessed the work being done over here and took a similar view that a novel toxin could not be ruled out, taking into account that Professor Makin did not think the solvent was the issue, we saw no immediate reason to suppose that was the answer and to alter policy on the basis of it. Having said that, obviously we recognise that this could be an issue. We have done quite a lot of work. We have published quite a lot of work on trying to get to the bottom of whether solvent carry over or other factors of this nature might have been the reason for this, but that is as much as one could say. We certainly did not immediately draw conclusions. Q82 Ms Atherton: Since the current assay was introduced, I gather there have been numerous insufficient sample and operator error reports in the results. Is that true? How could you explain that? Dr Bell: I do not think any of us are aware of that. Q83 Ms Atherton: Perhaps you would be kind enough to come back to us with the extra information if that is the case? Dr Bell: Yes, certainly. Q84 Ms Atherton: What is your response to the Shellfish Association's assertion that other laboratories have been unable to replicate the CEFAS results? Dr Bell: I am not aware that other laboratories have been asked to do that sort of thing. Q85 Ms Atherton: Would it not have been a sensible thing to do? Dr Bell: Yes, but it is difficult. You have to recognise that you have to use the same material. You are dealing with very small amounts of material in most cases in this sort of issue, so trying to reproduce across laboratories is quite a difficult process in these cases. We have seen a lot of similarity in the way that at least two laboratories have turned up these results and it is fairly clear that the third laboratory would not necessarily turn up the same results with the methodology they were using. There may be a variety of reasons associated with that, including the method of extraction. Q86 Ms Atherton: I understand some other countries such as Holland have tried to replicate the results and have been unable to do so. Dr Bell: I do not have the information at my finger tips. We will look into that and write to you if that is the case. Q87 Chairman: We are quoting Professor Makin who said that there was no evidence that the atypical result was due to the presence of ether, but Dr Askew tells us in his evidence that he also agreed that he could have said there was no evidence that it was not caused by ether. In relying on his endorsement either way, we are going to fall down because that is not really saying one thing or the other. Dr Bell: I do not think we did rely on his opinion in that regard. We took note of it and that was his considered, professional view. That is what he said, but we did not rule out the possibility that ---- Q88 Chairman: He also said it is not caused by ether; there was no evidence that it was not. Dr Bell: His considered view was that he did not think that solvent carry over was the reason for the effects. Nor, come to that, did a number of other experts including Professor Yasumoto. We did not rule out that possibility. We have done work to see what we are dealing with in the way of solvent carry over and the amounts that have been found are far below those that are known to cause toxic effects in laboratory animals. It is very difficult to prove negatives with these things. Q89 Chairman: Surely the cases Professor Yasumoto dealt with when he came over would be based on samples which were produced by the methodology which the Shellfish Association is saying was flawed and you are saying was not, so he was working on the same material? Dr Bell: Yes. He witnessed this methodology when he came over. He did not think it was seriously flawed, but he did not do it himself at the bed. He witnessed it being done. He did work on those extracts. I do not have the detail at my finger tips but I would imagine, since he is somebody who has been immersed in this area of work for very many decades, that he would not just have taken a sample and tested it in animals without having a look at things like whether it had a large amount of solvent in it. Q90 Alan Simpson: A number of the people who have made submissions to the Committee have made their own references to the difficulties about having an independent laboratory assessment of the evidence and the conclusions that you are drawing. Would you accept that there is a perception of the non-independence of the National Reference Laboratory? Dr Bell: The difficulty is that the National Reference Laboratory is embedded within the laboratory in Aberdeen. We are assured by Aberdeen that they work independently of each other and we have no reason to suppose that is not the case, but from a perception point of view I agree it is difficult to be able to demonstrate that conclusively when they are part of the same organisation. That is something we need to look at for the future, but we certainly would not take the view that we consider they operate other than in an independent fashion in this matter. Q91 Alan Simpson: Would you accept there is a case to be made for something that was genuinely independent and seen to be independent? Dr Bell: Yes, I think there is a case to be made for that simply because of where they are housed and which organisation they are part of. It has inevitably to be a case of Chinese walls in that situation. It depends what faith one puts in that arrangement but I agree that to be absolutely certain one would want to have it perhaps based somewhere else or clearly divided away from the rest of the organisation. I would add that we have no reason to believe that they have not acted independently in this matter. We have seen no evidence that they have not, as I said before. Q92 Alan Simpson: Without going down the path of saying that, if that was the case, who should it be, if I could focus on the principles of this, would you accept that if we are to address the communications issue - and clearly there is a problem to be addressed - there would have to be a commitment that the science that underpins that reference laboratory would be rigorous and open? Dr Bell: Yes, absolutely. Q93 Alan Simpson: One of the points that really rankled with me was in this reference to the suggestion that the FSA has banned communication, going so far as to threaten officers under the Official Secrets Act. How do you justify that? Dr Bell: I have no idea what that refers to at all. Certainly we do not operate in that way. As you know, we have prided ourselves since our establishment in 2000 as being an open organisation and hopefully a constructive organisation in those we deal with. Q94 Alan Simpson: Are you saying that the FSA would refute that allegation? Dr Bell: Yes, absolutely. Q95 Alan Simpson: If we were to turn that back to the industry and say that that is a pretty robust accusation to make ---- Dr Bell: If there is evidence of it, I will look into it. Q96 Alan Simpson: We can ask the industry to come back on that? Dr Bell: If they have firm evidence on that, I will look into it. Q97 Alan Simpson: Whether the FSA come out of this well or the industry comes out of it well, it is quite clear that the mouse comes out of it pretty badly. I want to raise questions about the validity of the mouse bioassay and whether you regard this as an adequate, acceptable form of testing, because we have had disputes about the methodology and the consistency of application of that methodology. I just wanted to get your thoughts on the adequacy of the test itself. Dr Bell: I think the test inevitably has a number of drawbacks. There is no doubt that we would ideally like to move, where we could, to a more precise chemical test, but there are a number of difficulties associated with this. One is that you have to have good standards on which you can base your chemical test. They do exist for some of the toxins. We are talking now about ones we know about. They do not exist for all of them. You have to have a chemical test validated. We are pressing within the Community to move in this direction as fast as possible and we are pressing for the European Reference Laboratory to take a lead on this. I am glad to say they are now getting a grip on the matter. You can only really use chemical tests where you know what the toxin is; it is characterised, you know how to recognise it and you know where the peaks are in the chromatogram. Where the difficulty comes is that it is very hard to see how you can avoid using a biological test at all because the only way you can pick up new toxins is by using a biological system by definition. It is very difficult to see how else you can do it. What we would like to see is the mouse test used, if you like, to support the rest of the tests and not be the definitive test. We would like chemical tests to be the definitive tests wherever possible but with the mouse test as the back-up to pick up anything that may suddenly appear, as with this Irish toxin that they found a few years ago which had not been known before and which you would miss with a chemical test because you simply would not see something you were not expecting. Q98 Alan Simpson: Can I ask whether you have taken a view on the appropriateness of the New Zealand regime, the fully validated chemical testing regime? Dr Bell: I think that is certainly a step in the right direction. I do not think that brings all the answers for the reasons I have described, but there is a lot of work going on round the world now to develop good, robust chemical tests for the known toxins. What we would like to see is this being brought forward into Community law so that we get definitive tests for the toxins we know about. Q99 Alan Simpson: Have you made formal submissions to the EU about your preferred chemical testing regime to replace the MBA? Dr Bell: We have written on a number of occasions and made formal representations on the need to move to a chemical based system where at all possible. Q100 Alan Simpson: Have you done the work that made the submissions? The Committee receives evidence in all sorts of circumstances where people are saying to us that someone else should do the work. Have you done the work? Have you put any proposition up at a European level that would allow that moving on process to be driven by us? Dr Bell: Yes. We think this has to be something that we work across the Community on but we are doing work at the laboratory chemist, developing these methods. We have asked them and they have been looking to see if they can find a chemical profile for what might be in the samples that are giving the atypical results. They are seeing a lot of material there but they cannot be certain which of that might be giving rise to these results, if at all, so there is work to be done there, but we are doing work in this area and we are urging the European reference laboratory to coordinate action across Europe. We are now beginning to get some action on this and there is a working party coming up very shortly that we shall certainly be taking a strong lead in. Q101 Alan Simpson: We have not got to a point of putting any counter or replacement proposals on the table for consideration about this different European approach that you say we need? Dr Bell: We have not put down definitive methods on the table and said, "That is what we should go with." Such methods do exist in some cases and we would certainly support those but we have not got that far because we have been trying to raise enough interest to get the matter properly discussed so that we can move in that direction as swiftly as possible. I think it is a matter of degree. It is certainly not a lack of intent. Q102 Alan Simpson: If we were trying to wrap all of this up, it seems to me that from the industry perspective and from an ethical perspective we have serious doubts raised both about the validity of this form of testing and the consistency and rigour of the testing process. The biggest criticism, I suppose, that has been levelled at the door of the FSA is that you have used the precautionary principle not to protect the public but to protect your own perineum. I wonder whether you can justify the size of the outcomes of the tests that you are now conducting to say, "We have a case for a ban." Dr Bell: That really is the nub of the matter. The principal difference between the position we have taken and the one that the industry has taken, as we have heard today, is that we are not ruling out a whole range of possible explanations for this, including the presence of a possible toxin. If that was to be the case, it would obviously be our responsibility to try and protect public health as much as we can from the presence of that toxin. We do not know for certain there is a toxin there. We are doing work to try and be clear about that, but while we do not know we are very much minded to take the advice that was presented by Lord Phillips in his report that one should take precautionary action to protect public health in areas of uncertainty of this type. We think there is a range of possible explanations. That is one of them. The way I see it from the industry point of view is that they seem to have firmly ruled that out and I cannot see the evidence for firmly ruling that out. Q103 Chairman: Why was the Scottish Food Standards Agency more accommodating than you? When the Aberdeen laboratory began to test in the same way as CEFAS was testing, they too started killing mice and then they reverted back to their former procedure, with the consent of the Scottish Food Standards Agency. Dr Bell: They certainly were. They are part of us as a whole because we are a UK body and the director of Scotland reports to me. The position there was that, in the hands of the people in the Aberdeen laboratory, using the standardised method that was brought in in June - this was before we resolved all the issues and brought in a better one later in the year - it was felt that there was likely to be more solvent in there than they thought was appropriate. They felt they could smell it in the final extract. Clearly, to use that on animals was contrary to their Home Office licence. If they felt there was a risk they might be killing the animals through having too much solvent present, they should not do it, so they paused at that point, consulted FSA Scotland and said, "Should we carry on or not?" and clearly the advice was, "No, you should not carry on until you have satisfied yourself that you are preparing the samples as rigorously as possible with minimisation of solvent." Further work has been done to ensure that we have reached that stage now, where everybody is content they can operate the method effectively in their own laboratories to achieve that. Q104 Chairman: Has there been a report by the government chemist on the procedures? It is my understanding that there has been. Can we have that report? Dr Bell: The work that has been carried out at the government chemist, which we commissioned, has been looking to see whether we could chemically identify a new toxin in the extracts. They have done quite a lot of work looking at the chromatographic profiles that they are finding, comparing those with other profiles they have had, to see whether they can find something new in there that may then warrant further investigation. Q105 Chairman: Have they? Dr Bell: They have found a whole range of unexplained peaks and they need to do further work now to see whether any one of those may be the reason for this effect and then whether this amounts to a new toxin. They have done quite a lot of work but they need to do more. That is the work they have been concentrating on doing. Clearly, if they were to identify a peak as being the cause and it was a toxin, they would not only demonstrate a new toxin but simultaneously they would provide a chemical method for it, so it would be a very powerful outcome if it could be achieved. We are too early on in the process to be able to draw any conclusions, I think. Q106 Chairman: Alan mentioned people being silenced. This is a scientific argument, is it not? You need the exchange of information between scientists and specialists so that you can get a common ground of understanding. I have had passed to me a letter which was from Dr Wadge which says, "Godfrey Howard", who has given evidence, "has been involved with the Scottish monitoring programme for shellfish toxins." If, as you suggest, he has been keeping you informed of progress on FSA funded contracts, he has been breaching the confidentiality clause of the FRS contract with the FSA in releasing early preliminary results to third parties. That seems to me totally undesirable. This is an argument between scientists in which you need the exchange of information. Dr Bell: The position is always the same. It depends what work is being done. If the work is just being overseen to see that it is being done correctly, that seems perfectly in order and is a matter between the contractor and the laboratory doing the work. Once results start to appear and they are properly checked and they are robust, I think it is absolutely right that everybody should have access to them and discuss them. It is a matter of argument as to what stage of the process that is. If you release results literally as they come off the beds, you are prone to finding that you have errors in there and starting all manner of hares running unnecessarily. It is the way that scientists normally work. They like to have their results looked at. They like to go over them themselves and they like to be reasonably satisfied with them before they expose them to the gaze of their peers. I think that is perfectly in order. My argument is that you do not release them absolutely at day one but you release them as quickly as you can, the necessary people having satisfied themselves that they do not contain errors. Q107 Alan Simpson: Is not that one of the big criticisms that runs through the allegations made against the FSA that, by and large, you had to be dragged into openness in terms of inconsistencies in the methodology? Whether it is backed up with the formal threat that it is a breach of the confidentiality clause or not, both the timescale and the processes that you work to have been much more focused around defending that original decision that you made than checking the rigours of the scientific method. Dr Bell: No. It has been very much focused on protecting public health. That is where we have come from all along and that obviously has been our driver. I make no apology for that. To that extent, we had to take note of what was coming out of here, even if other people quite rightly had doubts about various aspects of it. We had to say, "We will look at what the other aspects are but in the meantime we have to continue to go down this path because we cannot just pause and put the whole thing on ice while we investigate methodologies and all the rest of it." We are being faced with positive results in accordance with the tests that the EU require and we have to decide what to do with those positive results. We decided we had to take precautionary action on the basis of them, but we have always acknowledged that the methodologies are not ideal. We know the biological test is not ideal in itself. We know that standard operating procedures did not exist, so there have always been areas that needed further investigation and we have tried to run all these investigations in parallel. It takes time as the Irish demonstrated when they did it. It took them a number of years and I know we have heard that to some extent there might have been some foot dragging there but from what we found out, in discussing it with the scientists, these really are difficult problems to crack and they do take time to get to the bottom of. Q108 Chairman: You have been accused by the Shellfish Association of being heavy handed, grudging with information, secretive and of a persistent reluctance to admit that you might have been wrong. What is your assessment of the way the Food Standards Agency has handled this issue? Dr Bell: I am bound to say that we have handled it in what I would consider to be the correct manner, but I can understand the sensitivities attached to this. I think we have a lot of sympathy for the position the shellfish industry has found itself in. We have zoned the beds as far as we were able to, to enable as much fishing as possible to continue. Despite what you have heard today, I would argue that we have had frequent and repeated conversations on both sides. We have had many letters. We have written many explanation letters back. We have exposed all the work we have done. We have published the results and we shall carry on doing that. Naturally, people see it from different points of view. We see it very much from the point of view that we do not feel we can ignore what could be pointing to a new toxin. We do not know whether that is the case yet. Others whose livelihoods are at stake here I quite understand might think that that was being too precautionary and there will be a difference of opinion on that but that does not mean to say we cannot continue to talk together and try and work to a common solution, I hope. Q109 Chairman: Is not there an argument here for rebuilding working relations with the industry and with the local food authorities? Dr Bell: Yes. I would certainly hope things have not got to the point where we do not have a working relationship. I have heard what is said today. I think we need to redouble our efforts, I might say on both sides, to ensure that we work together to get a solution as quickly as we can. I can understand the frustration at the time this takes and we are doing all we can to get things moving and make sure we get to an end as quickly as we can. No purpose is served by being at war. I hope that is not the position we are at. I do not recognise that position and we would want to continue to talk and work with all the parties that are involved in this. Q110 Alan Simpson: Is not the logic of what you are saying that, if we are to believe that the risk element that you are concerned about justified the application of the precautionary principle, should we not be saying as a government that that has to apply to the importation of all mussels? If we are talking about a common European position and the protection of the public, when you buy stuff from the shops, you are not saying, "I am buying this because it has come from the UK", I suppose, or because it has come from Germany or the Netherlands. You are buying the product. You are making a judgment that says, "We do not believe it is safe to sell this product." If that is so, surely in terms of protecting the public it is not origin determined; it is determined on the basis of whether precisely the same tests that you are insisting we go by as the measurement of risk to public health are applied to every part of that industry. Dr Bell: Yes, that is absolutely right. We are looking for a level playing field and quite rightly so. A lot has been made of the fact that other European countries use other variants of this, the rat or whatever. We have written to the Commission and we have had it definitively from them. We have also spoken to the Dutch and we know it is the case. You can use other tests but you are required to demonstrate their equivalent, which is very difficult. However, in the case of doubt where you get a different answer with the mouse test to the rat test, the mouse test is the definitive test. That has clearly been laid down by the Commission to us in writing and in other ways. What we are looking for is to move as quickly as possible to more robust forms of test right across the Community. This is what we are talking about within a week now, round the table. We want to get chemical tests in where we can and we want to be much clearer about what the standard operating procedure ought to be across the whole of Europe, not just the one we might operate or the one the French or the Dutch might operate. I think that is the way we have to go. I do not think it is an ideal situation but we have to operate within the framework that we have and we have to move as quickly as possible to resolve these differences. Q111 Alan Simpson: If we are going to apply that principle and say that we are concerned about something that we do not know, to a point at which we are prepared to ban it, that has to apply to the importation of the same products from different countries who do not use precisely the same testing methodology that you use, because it would fail at that first test. Do we know? The answer is no. I am pushing you on this because we either have to have a position that is tenable across the food sector or no position at all. Dr Bell: I accept what you say. I think there is a case for what you do about imports. There is equally a case for what you do about your own production. We have heard most of it is exported and it is an important industry, which we accept. We have to protect our own population. We have to decide what we are doing about the results we are getting from shellfish from our waters. That is what we are doing, but I equally agree with you that we need to make sure that, across the Community, we are on a level playing field and that testing is being done in a similar way to protect public health. I have no evidence that the shellfish that are coming from outside the UK waters have this problem. You can say that is because people have not looked in the right way. You can make that argument certainly. The rat test may not pick this up. We are not clear about that. It has a mouse test at the back of it. At the moment, I am trying to work with the problem we have but not ignoring the fact that we need to work in the Community to get everything properly set up so that everybody gets the same answers across the Community. Q112 Chairman: I have a couple of other questions which relate to farm salmon, not part of our agenda, but since you are the chief executive of the FSA and since it is so topical I put them to you because I think they are important. We may need to look at this as a Committee at some other stage but since we can get some preliminary answers from you now I would like to put these questions. It relates to the material published in Science by researchers from Indiana. The FSA effectively pooh-poohed them, emphasising the known benefits of eating oily fish. I am a great advocate of everybody eating as much fish as possible, particularly fish that is caught by the Grimsby fleet which is not a very large quantity now. Should we continue to eat farm salmon? Dr Wadge: The evidence produced on the levels of dioxins in salmon was nothing new. It matched the types of levels that we reported ourselves a few years ago. This was a much more extensive study and it looked at Pacific salmon and compared them with the farmed salmon from Scotland. It did not compare like with like. It did not compare farmed salmon with Atlantic salmon. The big difference in this particular study was the approach that the researchers used to assess the risks to health. They took a model developed in 1991 published in draft form, which incidentally has never been finalised by the United States Environmental Protection Agency, which assumes that whatever exposure of dioxins someone receives there will be some level of cancer risk. That is making an assumption that dioxins at whatever level carry with them a risk of cancer. An awful lot of work has been done on the toxicology of dioxins. It is probably one of the most well studied environmental contaminants since 1991. The World Health Organisation, the United States Food and Drug Administration, our own Committee on Toxicity and the Scientific Committee for Food which advises the European Commission have all looked at this subsequently and have said that dioxins do not operate in this manner. There is a threshold below which there is not thought to be any harmful effect over a lifetime of exposure. We have taken that more recent, what we consider to be more appropriate, risk assessment that is widely accepted internationally by the World Health Organisation and compared the sort of exposure that you would get if you consumed salmon as part of your healthy, balanced diet. We have said the levels are within those accepted guideline values. Set against what is really a theoretical risk are some very clear, known benefits of eating oily fish as part of a healthy, balanced diet, such as protecting people from cardiovascular disease, one of the biggest killers. That hopefully explains the difference of approach that has been taken. Q113 Chairman: How are the safety limits for toxins and PCBs and dioxins determined for farm salmon? Who fixed them and how do you enforce them? What are they? Dr Wadge: There are independent, expert committees that advise the World Health Organisation in this case, which will look at the toxicity of a particular compound such as dioxins and work out, not in relation specifically to salmon, but how much a human being can ingest over a lifetime without any adverse effects. Having established that guideline value, you will then look at dietary intake information. We carry out surveys as to what food people consume and you look at the total dietary intake, of which salmon will be one part, and you compare that with the guidelines established by the independent experts. That is the basis on which we are able to say that the UK diet and the salmon intake do not present a risk from dioxins. There are now quite tight controls on the levels of dioxins permitted within the fish feed. Those are controlled at a European level. Q114 Chairman: Does it accumulate in salmon? Dr Wadge: Dioxins do accumulate. Dioxins are essentially there as a legacy of past industrial activity, so they will accumulate in the environment, probably in the sediment, and gradually accumulate in the food chain. The good news that we have from our quite comprehensive dietary surveys shows that the levels of intake that people are exposed to have dropped by at least 50 per cent in recent years. That reflects the controls on industrial emissions. Q115 Chairman: The limits used by the FSA in determining the safety limits for toxins differ from those in this study because you are saying yours are more up to date? Dr Wadge: We have taken advice from the World Health Organisation and our own Committee on Toxicity, who have looked at the recent evidence on the toxicity of dioxins. These researchers from the University of Illinois did not carry out, as I understand it, their own risk assessment. They used the USEPA model which assumed that, whatever exposure occurs, there is some risk of cancer. We think that the new scientific information on the toxicity of dioxins does not support that approach. We think it is inappropriate. Q116 Chairman: You do not see a need for invoking the same precautionary principle that you invoked for shellfish? Dr Wadge: We would always take a precautionary approach and we would look at the exposure against the risk assessment carried out by independent scientists. In this case, the big difference is we know what the toxin is. We know what the effects are. We know what the levels are in the food and we know what the exposure is, so it is quite easy to make that comparison. The shellfish situation is very different because we simply do not know what is causing these atypical effects. Q117 Mr Drew: I wonder how much resource you are putting into studying some of the issues to do with fish. Give us a feel for the sort of work comparison that it might be possible to draw compared to meat, where we are, dare I say, hopefully at the end of a lot of various scare stories and have done some invaluable work, if nothing else, to be able to tell the rest of the world how to try and avoid BSE and how not to do some of the things that we got wrong. Could you give us a feel for the research in this area? Are you under-powered in terms of being able to pull together? As Austin said, we go into salmon; we have looked at shellfish and some of the other problems which affect this industry pretty drastically. Dr Bell: I cannot give you a figure off the top of my head that covers all the research spend on fish per se. On shellfish we have spent around 300,000 on research in the last couple of years, trying to get to the bottom of this issue. We spend nearly £1 million a year on paying for the testing and all the aspects that go with that. If you want to compare it with what has been spent in the meat area in the last few years, obviously there is little comparison there because, we you well know, the expenditure on BSE has been simply huge over that period of time. One might argue, I hope, that because of that huge expenditure and what we have learned in the process we can get a grip on things at rather less expense in the future. A lot of that was done with hindsight and maybe more could be done at the beginning. I do not know, but there is not really a comparison in that way to be made. The sums are quite different. If you are interested, I am certainly prepared to look out the figures we are spending on fish generally across the board and write you with some breakdowns on that. Chairman: Can I thank both of you particularly for your patience in dealing with these last, extra questions and for your evidence. If you have anything which occurs to you which you think would be helpful to us, please do not hesitate to send it to us in writing as quickly as possible. I hope a bit of marriage guidance can come out of it and Relate can bring the parties in this dispute together, but we are dealing with the story of the divorce and the acrimonious dispute when we write the report. Thank you and thanks to the other parties for giving evidence today. |