UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE
To be published as HC 692 -i

House of COMMONS

Oral EVIDENCE

TAKEN BEFORE the

Environment Food and Rural Affairs Committee

the use of CLONED ANIMALS AND THEIR OFFSPRING in agriculture

Wednesday 15 December 2010

Mr James Paice MP, Lord Rooker and Mr Tim Smith

Evidence heard in Public Questions 1 - 84

USE OF THE TRANSCRIPT

Oral Evidence

Taken before the Environment Food and Rural Affairs Committee

on Wednesday 15 December 2010

Members present:

Miss Anne McIntosh (Chair)

Tom Blenkinsop

Richard Drax

George Eustice

Mrs Mary Glindon

Neil Parish

Amber Rudd

________________

Examination of Witnesses

Witnesses: Mr James Paice MP, Minister of State for Agriculture and Food, Department for Environment, Food and Rural Affairs, Lord Rooker, Chairman, the Food Standards Agency, and Mr Tim Smith, Chief Executive, the Food Standards Agency, gave evidence.

Q1 Chair : Good afternoon. May I welcome you most warmly? Thank you for your patience. We were slightly delayed, owing to our private business, but may I welcome you most warmly, starting off with the Minister, Mr Paice. Could I also extend a very warm welcome to Lord Rooker on his first visit in this Session? Would you like to introduce Mr Smith for the record, Lord Rooker?

Lord Rooker: Yes, I’m Jeff Rooker, member of the other place and Chair of the Food Standards Agency nonexecutive board. I’m accompanied by Tim Smith, who’s Chief Executive and Accounting Officer.

Q2 Chair : Thank you very much indeed. We’re particularly probing the use of animal cloning in agriculture, after the events of the summer. I’m wondering, if I address this question to both the Minister and you, Lord Rooker: what is the relationship of the FSA to both DEFRA and to the Department of Health?

Lord Rooker: The relationship? We’re a Government Department. You’ve got two Government Departments represented here. We’re not the agency of any other Government Department. We were set up as a nonministerial Department in the legislation from 1999. Our relationship with Health: because we’re a UKwide body, we answer to the four Parliaments through the four Health Ministers. The Health Ministers are our post box only. We don’t answer to them; we answer through them. We’re no different from the other 20 nonministerial Departments; we’re not unique in that respect. We may be called "Agency", but we’re not the agency of a Government Department.

Our relationship with DEFRA is the same as it would be with the Treasury, except that the Treasury gives us money and DEFRA doesn’t. They’re another Government Department, and our relationship is very much working in cooperation or partnership simply because we’re responsible for surveillance and enforcement in the meat industry, regarding the abattoirs and cutting plants. Some of the work we do there, in effect, is contract work for DEFRA, such as the animal welfare side of things. We are the food safety regulator; we’re the UK competent authority for food safety, but legally we’re constituted as a nonministerial Government Department.

James Paice: Lord Rooker has described the formal relationship, which I could say informally is a good working relationship. In terms of responsibilities, which may be behind your question, Miss McIntosh, the Food Standards Agency deals with, as its name implies, the safety of food. In the context of cloning, obviously it is about the safety of food from clones or their descendants. The role of DEFRA in this context and in relationship to this, as a result of recent Government changes, is that food labelling relative to welfare is a DEFRA responsibility, and obviously animal welfare is entirely a DEFRA responsibility. I hope that’s helpful.

Q3 Chair : Which website would the farmer normally be directed to in terms of cloning and the procedures to be followed for spinoff products from cloned animals?

James Paice: It depends what he wants to do. If he’s trying to look up what the rules are about the sale of food products from clones, then it would obviously be the FSA.

Tim Smith: We know that the links, if I might, between the FSA and DEFRA websites in relation to cloned food, meat and milk work very nicely.

Q4 Chair : You think it was sufficiently clear.

Tim Smith: When we’ve talked to the farmer in question, specifically the gentleman from Nairn, it was obvious that he’d talked to the National Farmers Union in Scotland and other trade representatives, and they pointed him in the direction of both DEFRA and the FSA. He’d sought their advice and obtained it very clearly.

Lord Rooker: Can I just add: that’s been the situation since 2007/08. There’s nothing new about this.

Q5 Chair : Could I just ask a broad question? What’s the relationship between the FSA and the European food standards agency?

Lord Rooker: The same as it would be for any of the food safety competent authorities in any of the Member States. EFSA was set up after the Food Standards Agency. In fact, the first Chief Executive of EFSA was the first Chief Executive of the Food Standards Agency, Geoffrey Podger, who currently is Chief Executive of the Health and Safety Executive. Tim is probably better placed to answer this than me, because I’ve not been over there, but they were set up as the European competent authority. They will do some work and issue edicts, and we will feed into that, and we will get advice from them, as indeed we would feed in to them constructing their advice. Particularly in some of their early work about the methods of regulation, for a start, the way we operate in this country is quite different and has been followed by many others.

Tim Smith: The difference between EFSA, the European Food Safety Authority, and the Agency, is that they are solely connected with food risk assessment. They’re doing risk assessment, which we and other Member States do rely on. As Jeff would have said in introducing the Agency, we have 10 independent science and evidencebased committees, and one of those committees actually is responsible in the UK for providing advice to the Agency, which then in itself feeds into the work of the European Food Safety Authority.

Q6 Chair : Thank you. In terms of the ethics of using cloning for food production, which Department or body oversees the consideration of the British public’s interest, where there’s evidence that the public may oppose the use of food production techniques such as cloning? Which body would be responsible, Minister?

Lord Rooker: That would be DEFRA.

James Paice: Yes, it is DEFRA in as much as the issue, frankly, is a Government responsibility. Obviously the FSA’s responsibility is on food safety; ours is on issues to do with welfare, but the Government’s overall approach is, after that, there’s no formal role for Government.

Lord Rooker: We have a statutory duty under the Food Standards Act 1999 to put consumer interests first, above and beyond all else. From that point of view, we are very interested in the way consumers are dealt with in terms of whether they’re misled and issues like that. We work in cooperation. For each issue, there has to be a lead Department. We lead on the safety of the food. In terms of animal welfare and the ethics, then the lead would be DEFRA, but we would be working in cooperation with them because we’re interested in the consumer angle.

Tim Smith: We can’t have a conversation with consumers about cloning without welfare and ethics featuring very strongly. Even as we, as Jeff says, are very interested in what consumers think about food safety, you can’t do that in the absence of conversations with consumers about ethics and welfare at the same time.

Q7 Amber Rudd: Could I just ask on that point, because it’s so interesting: do you think that the public are more in fact interested in their own health and the health of the consumer, or is it in fact an issue of ethics when they think about cloning?

Tim Smith: We did a very substantial piece of research in 2007 and 2008 on using deliberative consumer panels, so bringing people back and asking them how they’d changed their opinion once they’d had some information fed into them. In essence, food safety dropped down the list of things that consumers were interested in. They were more interested in the ethics of animals being required effectively to produce progeny from clones. They were more interested in the welfare of animals that would be born as the progeny of clones than they were about their own food safety. They were particularly concerned about whether big organisations, including Governments, could be trusted to give them advice on that, which is where our particular reference point is, because we have that consumer trust.

Q8 Chair : My particular concern is that one moment we were told that the FSA was going to be abolished, then we were told it would be retained with a focus on food safety, and that DEFRA would take on the nonsafetyrelated food labelling and the Department of Health would be responsible for nutrition policy. What the Committee is anxious to understand is that we’re not falling between three stools of Government-the FSA, Health and DEFRA.

James Paice: I’m sorry, Miss McIntosh; it was never stated that the FSA was going to be abolished. You can believe what you like if you read newspapers, but the Government never made a statement to that effect and it was never policy.

Lord Rooker: That is the case; I can confirm that as well.

Tim Smith: I think the clarity of purpose of the two organisations in respect of cloning is absolutely clear, and when we talk to the farming unions and farming representatives, they’re very clear on who is interested in embryos, who’s interested in imports of meat, who’s interested in food safety, and the clarity that we now have is probably better than it was prior to the election.

Q9 Neil Parish: On a general point, the mortality rates of clones, especially in pigs and what have you, is high. Is that, Mr Paice, an interest of DEFRA? Is it of any interest to the FSA? This is very much an animal welfare issue and something I feel quite strongly about. How do we deal with that?

James Paice: Mr Parish, you’re absolutely right that welfare is of course our concern. Frankly, DEFRA’s only real concern on the issue of cloning is the welfare of the cloned animal or, indeed, its surrogate parent, because cloning involves a surrogacy. I think we need to recall that the technology is developing very, very fast and, therefore, the welfare aspects are improving or the problems are diminishing all the time. In legislative terms, existing welfare regulations are sufficient. We’ve got the overarching Animal Welfare Act 2006, which the previous Government passed with allparty support. Then you also have the Welfare of Farmed Animals (England) Regulations 2007, which are based on the European Framework Directive 1998/58/EC. That deals with the whole issue of the welfare of what it calls artificial or breeding procedures of livestock, and it prohibits any of those procedures that cause or are likely to cause suffering or injury to any of the animals concerned, and says they must not be practised. I won’t detain the Committee unless you wish me to, but there are a number of other legislative aspects, including the work from the Royal College of Veterinary Surgeons, the bovine embryo regulations, and so on, all of which have an impact on this, but we believe that, within that overall framework of legislation, there is the necessary protection to address any welfare issues arising from cloning.

Q10 Neil Parish: I think the mortality rates in piglets can be up to 30% or 40%. Hopefully, as you quite rightly say, it’s getting better, but don’t you think that is too high?

James Paice: Yes, I do think 30% to 40% is high but, as I say, it is improving all the time, and we’re not aware of any pig cloning in this country, at any rate, happening at all. I must stress, Miss McIntosh, that as far as we’re aware, the only cloning animals-cloned or offspring of animals in this country-are the ones that gave rise to the story of whenever it was: eight offspring of cloned and 85 or something like that subsequent offspring.

Q11 Neil Parish: Would you necessarily know whether pigs or cattle or whatever are being cloned?

James Paice: No, we wouldn’t, and that’s the nub of the problem when you come to the whole issue, which I’m sure the Committee will want to consider, which is labelling and therefore consumer choice. Firstly, we don’t know if animals have been cloned or cloned offspring have been imported. Secondly, there is absolutely no way of telling whether the meat or the milk is genetically identical and safe. That’s a job for the FSA; we believe it to be safe. You could not enforce any form of traceability. That’s the fundamental problem.

Q12 Amber Rudd: Lord Rooker, could I ask you, are you convinced that there are no food safety concerns arising from eating cloned livestock or their offspring?

Lord Rooker: The way you pose the question, I’d qualify it by our advice is only related to cattle and pigs. To make that absolutely clear, we don’t have sufficient evidence on other species. First of all, I have to make this clear: in respect of cloning itself, the cloned animal, legally, is a novel food. There’s no question about that, the actual clone.

Q13 Amber Rudd: It’s a what, sorry?

Lord Rooker: It’s a novel process. In other words, it wasn’t used before 1997. That’s the definition. There’s nothing unsafe about it being novel; it’s just that that has a different set of regulations. The board of the FSA in September requested our scientific advisory committee take a hypothetical application-we’d not had an application from a food producer seeking approval under the Novel Food Regulations-so we put it through hypothetically. The evidence they have, which they’ve assessed-they’ve got the EFSA information as well as other papers-really only relates to cattle and pigs. They made it quite clear, in so far as the current evidence is available, the food-the meat and the milk-is identical.

Tim Smith: Two further qualifications, if I might. The first is that they’re only reflecting on the current form of cloning methodology, socalled SCNT. If they were to use pluripotency, which is a Japanese method of cloning, they’d have to have another look. Secondly, and probably more relevant to today’s discussion, they continue to monitor and want to monitor, in different environments, as animals are brought through the food chain, assuming they are, the effect that the environment has on the progeny of cloned animals, on their meat and milk. Emphatically this is cattle and pigs only.

Q14 Amber Rudd: I think that DEFRA previously accepted this from you, is that correct? Regarding cattle and pigs, it is in fact safe?

James Paice: It’s not for DEFRA to judge on food safety; it’s entirely for the FSA.

Tim Smith: Our advice to Ministers-all four Ministers in the devolved countries as well as here-has not really shifted in relation to the safety of meat and milk from the progeny of cloned animals, as we just defined.

Q15 Amber Rudd: What assessment did you make of the risks of cloned animals being more susceptible to disease and therefore being more likely to transmit disease to humans?

Lord Rooker: It’s in our own documents. At all times, we do not allow unhealthy animals into the food chain. There’s a prerequisite where, by definition, we’re talking about healthy animals as they’re presented for slaughter. These are early days, as Jim said in answer to Neil. First of all, the efficiency of cloning-I’m a layperson-is incredibly low. As a new technology, I’ve been astonished at how low it actually is. You can see why it hasn’t taken off in the way that people might have thought it would. Presenting unhealthy animals for slaughter is not acceptable, and we wouldn’t allow them into the food chain. The advice we have on the best available, most uptodate evidence is that, on the hypothetical application that our committee looked at on the evidence that they had of the meat and food products from cloned animals, if the animals are healthy, the food is safe. If the animals are not healthy, we wouldn’t allow them into the food chain.

Q16 Amber Rudd: This issue of the lower immunocompetence, which has been suggested might affect some cloned animals, did you consider that?

Tim Smith: No, but EFSA did. In their 2008 and 2010 stateofplay paper, they talk about the effect on the animal itself, and effectively say what the Minister and Jeff have already said, which is that animals are being checked throughout their lifecycle, so there is no risk to human health from food safety risks arising from those cloned animals or their progeny, simply because of the other checks and balances that are already there.

Q17 Chair : Could I just ask a point of information? Dolly the sheep was the first cloned animal. What is peculiar to cattle and pigs that you say that is not peculiar to other animals?

Lord Rooker: I asked about this the other day. This is another classic case. I thought, "The Brits invented cloning. How come we’re not leading the world on it?" We’re not. Apparently, Dolly the sheep was cloned for medical purposes; it was nothing to do with food production. Therefore, there hasn’t been any cloning, as far as we know, of sheep for food production. The cloning that’s taken in food production animals has been in cattle and pigs.

Q18 Chair : Could pigs not be used? I know a farmer in my own constituency was producing pigs for this purpose. Could cloned pigs not be used for heart valves for human heart surgery? Is there not a possibility there?

James Paice: That’s different, with respect, Miss McIntosh. That’s transgenics; that’s not cloning. A lot of that work is done in my constituency at the Babraham research institute just outside Cambridge. Transgenics takes genes from one species into another, which is very different from simply creating a cloned image of another.

Chair : We won’t go there today. Thank you very much indeed.

Q19 George Eustice: I want to ask you about the report that you commissioned in 2008 looking at public perceptions on this issue. One of the conclusions is that the public felt there should be more rigorous testing methods, rather similar to clinical trials that you might get for drugs and medicines. Do you think that’s something that should be considered to try to reassure public opinion?

Tim Smith: One of the things that consumers say to us most often is that they would like the same rigour to be applied to foodstuffs that is applicable to medical products, medicines and so on. What we found in doing the consumer research is that they know, when we press them, that that’s unrealistic. We know that it’s not riskbased and it’s not proportionate. When we do deliberative consumer research, we’re able to give reassurance to consumers that that isn’t necessarily going to give them any better protection when it comes to food safety, because we’re starting from a position when there isn’t a risk. It’s a different sort of risk, and it does take that deliberative consumer research to get that message across, which is why they then regard labelling as a surrogate for that testing having been done. It’s why labelling becomes more important.

Q20 George Eustice: You mean labelling for what purpose?

Tim Smith: Labelling to give them a choice; not labelling to say something’s been done, but labelling to give them a clear choice.

Q21 George Eustice: Do you not think though, if you could have a much tougher clinical testing and trial, it would make it easier to reassure the public?

Tim Smith: It might do, but there’s a law of diminishing returns. We would not gain any better information with which to advise consumers of the safety of food that arises from the progeny of clones.

Q22 George Eustice: My next question is linked to this issue of public perception. How challenging is it to get the facts that you’ve identified into the public media realm in particular? Do you find this difficulty that basically people’s instinctive reaction is that this can’t be a good thing?

Tim Smith: No, I think what happened when the research was done-and there’s a phrase that I find quite compelling-is participants felt animal cloning represents a quantum leap from "giving mother nature a helping hand" to "interfering with mother nature". Now, we think that’s interesting and relevant to the work that the Agency does, but the retailers, who have looked at the research, in the response to our materials on the website, which have been there, as you’ve said, since 2007, have taken a pretty much unilateral view that they will have nothing to do with food from cloned animals and progeny, if they’ve got a choice. That’s another surrogate for consumer behaviour and attitudes to cloning.

Q23 Richard Drax: Have you formally engaged the public about the welfare of cloned livestock and the ethics of cloning for food production? What are you doing in so far as informing the public and engaging the public on those two points?

James Paice: Our role is very much one of ensuring and recognising at the moment that there are absolutely minimal numbers, that we know of, of cloned livestock in this country, which we quoted earlier. The challenge is to inform the consumer of existing welfare legislation. Don’t forget all the furore about those ones we’ve got has been about food safety, not about their welfare, although obviously it’s given rise to the sort of questions that Mr Parish was rightly raising. As I say, our view is that the existing portfolio of legislation on animal welfare is sufficient to deal with all the welfare issues that might arise from the cloning technology, if people want to practise that technology in this country. We’re not aware of anybody in Europe practising the technology. All these animals have been imported, the originals, from the United States.

Lord Rooker: I repeat there has been no application from any food producer in the United Kingdom to get approval, under the novel food regulations, for cloned animals, either the first clone or the progeny. Industry, farmers, producers-nobody has made an application.

Q24 Richard Drax: We’ve tinkered with animals before, haven’t we, and we paid a heavy price? Is there any concern that tinkering with nature, as we’re trying to do potentially, could be the wrong road to follow?

Tim Smith: We have to rely on the evidence that’s presented to us. From the small number of animals that have been cloned in the States-there are probably about 550 cows out of a huge 100 million or so population-there might be 4,000plus animals that have been cloned, and their progeny, of course, are widely disseminated across the globe. There’s no emerging evidence or evidence of any sort that hints at a food safety risk or any sort of zoonotic impact of those animals or their progeny.

Q25 Amber Rudd: What’s that word, "zoonotic"?

Tim Smith: It’s the transfer of a disease from an animal to humans.

Q26 Neil Parish: Hopefully cloning won’t become a huge issue regarding the number of clones actually going into the food chain, because I just don’t like their mortality rates. If it were to become a real issue, would you, Minister, consider actually labelling as such? At the moment, I don’t think we are anywhere near it because of the numbers but, if we were, would you consider that?

James Paice: Mr Parish, obviously the present Government feel very strongly about consumer power, consumer information and the right to choose. However, as I stressed to you earlier, legislation and regulation have to be enforceable. The fact that you cannot detect whether the meat or milk is from a cloned animal or not, in my view, makes such a proposition impossible to implement effectively.

Lord Rooker: We said we can’t regulate what we can’t measure as the Food Standards Agency. That applies equally, as I said, to our role for consumers not being misled. DEFRA’s responsible for labelling as such, in terms of consumers first. If you can’t measure something-it’s a bit like the importation of materials as well-it’s very difficult to regulate. What we can do from the food safety point of view is take the best available scientific evidence we’ve got that the meat and the milk is-"substantially" I think is the technical term-substantially equivalent to that from ordinary animals.

Neil Parish: I would agree from a food safety point of view. That’s not my argument. From an animal welfare point of view, and I think this is targeted at Mr Paice, surely it is an issue for the public. If the mortality rate of the clones is high in young at birth and at young age, then surely the public should at least know that when they’re buying anything that could possibly be cloned.

Chair : We’re coming on to that.

Q27 Tom Blenkinsop: Minister, your comments now do reiterate what DEFRA said in October that it "would be very difficult to apply" and that "introducing a traceability system would be hugely expensive". If you compare that with the fact that Tesco, Asda and Marks & Spencer have said they won’t stock cloned products, is it possible therefore to identify for sure whether a cow or pig in the UK is the offspring of a clone? If not, is there scope for consumers to make an informed choice?

James Paice: To the best of my knowledge, the answer is no, it is not possible to identify whether meat or milk is from a clone, let alone the offspring of a clone. Therefore, it is actually impossible to have an enforceable system that would enable the consumer to make that choice. I’m very happy that supermarkets have said what they have but, to go back to our earlier point, it’s a pretty easy statement to make because it doesn’t really apply at the moment. Apart from that small number that we’ve already talked about, it doesn’t actually occur. If, at some stage in the future, we see cloning becoming a much more common practice, and therefore choice becomes a reality, clearly we might have to look at the matter again. Unless we can find a technical way of crosschecking that it’s enforceable, I find it very difficult to conceive a value to it.

Q28 Tom Blenkinsop: The European Commission states that a tracing scheme for reproductive material could be implemented, with a limited administrative burden, by noting whether the animal is a clone on existing certificates.

James Paice: Pigs don’t have certificates, for a start.

Q29 Tom Blenkinsop: Are you saying you don’t agree with the Commission’s point of view?

James Paice: I am. I’m not aware of substantive work behind the Commission’s statement that would enable that to happen. Yes, it is conceivable you could do it to a cattle passport, but my point is that’s the certificate that goes with the animal. Actually, when you’ve got a lump of meat on the butcher’s shelf, you really need to be able to detect it and trace back whether that’s been properly labelled, and that’s the point I’m trying to make: it is identical to any other equivalent chunk of meat.

Q30 Tom Blenkinsop: Is organic meat guaranteed not to be derived from a clone?

James Paice: Organic standards are a matter for the three validating certificating bodies within the overall EU standards. I’m afraid I don’t actually know whether the overall EU standards have even addressed the issue. I suspect they haven’t yet. It would be a matter for them to decide whether or not cloning should be acceptable within their standards.

Q31 Chair : Could I just ask, what is the status of the Commission communication in which they have set out three courses of action? The Commission communication normally, from my memories of EU law, is really something for Member States to take note of. They’ve set out three potential options: the status quo, total prohibition, or a mix of measures, which Mr Blenkinsop just referred to. If we’re saying that the consumer has the right to know, but we’re also saying that it’s impossible to give that information to the consumer, how are we going to proceed?

James Paice: As I was suggesting earlier, the first point about the status of the document is very much as you suggest; it’s a matter for discussion at Council of Ministers meetings. I presume both Agriculture and Food or Health Ministers will discuss it, but also it’s a matter for the European Parliament under the Lisbon Treaty, so they will all discuss it. It will not, as you rightly say, necessarily precipitate any new regulation or directive, but it’s open to the Commission to bring one forward, if they wish, at some stage in the future. That’s the issue of status.

As for your question about how we proceed on labelling, as I said, my view is that we have a conundrum that’s irresolvable, because we can’t actually produce a traceability that is watertight and you could enforce in order to support labelling. Voluntary labelling is fine. If supermarkets or any retailer wishes to say, "We will not stock any product from a clone or at any generation," or whatever choice they make, or any other form of husbandry, they’re all free to make those choices. They have to be sure they can establish a traceability system.

Q32 Chair : "They"?

James Paice: The retailer has to establish its own traceability system to be able to validate that claim. That’s a voluntary matter for them.

Q33 Chair : Are we talking about homeproduced clones in this country, produced clones in the rest of the EU or, as Mr Blenkinsop was perhaps questioning, those imported from third countries? I think you mentioned, Mr Smith, from the States.

James Paice: I’m talking about all clones, because the principles apply. Obviously the issue of traceability is slightly different, depending on where they’ve come from, as you suggest, but the principles of whether the traceability is enforceable apply to any source of clones. My point is that supermarkets or retailers have themselves to decide whether or not they can have a genuine traceability system to validate their claim of not selling cloned meat. That is different from a Government approach, which has to stand up in court.

Tim Smith: The due diligence defence for not misleading consumers is going to be incredibly difficult for them to stand up, given that we’ve already explained why tracing these animals and their progeny is impossible.

Chair : We’ll come on to that in more detail in a moment.

Q34 Mrs Glindon: The minutes from the FSA September board meeting noted that "the development of cloning technology…had outstripped the development of a regulatory framework and traceability systems." Does this not raise concerns about the efficacy of our system for monitoring the safety of new food production technologies?

Tim Smith: The first point to make is that all producers of food in this country and the rest of the Member States are aware of the Novel Food Regulations. It should be very clear to all those people engaged in food manufacture, whether as primary producers or as manufacturers, that if they’ve got a novel food, whether it’s a new sugar, whether it’s a new additive for softening margarine, whatever it is, they must put it through the normal food regulation process. We would not be having the same conversation today about cloning of animals for meat and milk manufacture, had the farmer concerned in Scotland applied for authorisation under the Novel Food Regulations in order to secure an approval through ourselves and through the Commission. That means that for every novel food, and our committee has probably considered 90 or so applications since it was first formed-typically six or seven a year at least-each one of those is dedicated to proving beyond reasonable doubt, to the extent that they can, that that food is safe for human consumption. While the minutes may reflect the conversation that was going on, the truth is that our independent scientific evidence base is set up deliberately to act as a filter for those activities. If people choose to sit off and not put their foodstuff, their new novel food, through that process, then they cannot market it; it cannot go on to the food market.

Q35 Mrs Glindon: If it emerges that there are significant human health risks from clones and their offspring, what would you do in relation to identifying food from clones?

Lord Rooker: What’s the premise of the question? The fact is all our evidence is based on scientific evidence; there are no hunches involved here. If the evidence changes, as we’ve always said, our advice to Ministers would change. Our current advice and the most uptodate evidence we’ve got from the scientists is that the food is safe and the food products are safe-the meat and the milk. You seem to be asking about dangers to human health.

Q36 Chair : It comes back to what you were saying about novel foods. I think there are procedures to be followed, so we have to identify the fact that the food has come from a cloned animal. That’s what we’re trying to establish.

Tim Smith: Can we be clear that food from cloned animals cannot enter the food chain? Food from the progeny of cloned animals is the subject matter, because no cloned animal has ever been authorised for sale, nor is it ever likely to be. If you follow the track of what the Commission, EFSA, and the FDA in the States and others are saying, it’s very unlikely that food will be derived directly from clones-there’s a moratorium in the States right now that prevents cloned animals themselves entering the food chain.

Q37 Chair : I’m not quite clear. You’re not responsible for the States but, if they’re not allowed to put cloned animal foodstuffs into the food chain, why-I’m not saying it’s unsafe-should there not be a moratorium on food from the progeny of cloned animals?

Tim Smith: The progeny of clones derive from a clone and traditional breeding methods. The discussion between the UK, other Member States and the Commission surrounds this very simple point: is an animal, once it’s been produced by traditional breeding methods involving a cloned and a noncloned animal, then a novel food? That’s the discussion that is still going on and is still the subject of legal deliberations. I don’t think there are any jurisdictions that allow food directly from clones to enter the food chain. What we’re always talking about is food that comes from the progeny of clones.

Q38 Mrs Glindon: The FSA noted that the responsibility of developing a traceability system lies with Agriculture Departments. Would this issue of tracing of the offspring of clones been dealt with earlier, before it became impractical to do so, if the FSA had been better integrated with DEFRA?

Lord Rooker: The answer to that is no, because there is no scientific method of actually checking and tracing. It doesn’t arise. First of all, and I repeat this to the industry, no application has ever been made for cloned animals, under the Novel Food Regulations. All the farmers are food business operators. They are legally responsible for the food they produce. The question of being integrated doesn’t apply because, first of all, the materials that are coming into the UK, whether they’re embryos, semen or animals, you cannot tell whether they have come from, two generations back, a cloned animal. It’s not possible to do so.

That being the case, there is no way you can set up a surveillance procedure. It’s just impossible to do. I know the implications of this are somehow these animals are born with a passport in their ear and a stamp on their backside saying how they were created. If artificial insemination had not been used before 1997, then artificial insemination would be a novel procedure. That’s the reality as far as the public’s concerned. It’s the simplest example I have ever come across, because it’s one you can understand.

There’s nothing wrong about a novel procedure; there’s nothing unsafe about a novel food. As Tim said, some 90 applications have been made in the past few years. A lot of novel foods have been approved by ourselves and other European Member States. There’s nothing wrong in being a novel food; it just happens to be the term for a food that was not generally used, or a technique generally used, before 15 May 1997. It’s a date I remember for some reason. It wouldn’t have been possible to have a surveillance procedure. No one would have known about it. As Tim said, the farmer concerned had never made any application anyway along the lines of, "I’ve got some possible novel food here. Would you like to check it out?" With respect, it wouldn’t have made any difference because you can’t track them.

James Paice: Miss McIntosh, I wonder if it would be helpful just to make a point, which perhaps the Committee hasn’t fully taken on board and is inherent in your question, of the difference between a cloned animal and the offspring of clones. There are no cloned animals in this country and there never have been, unless they’ve been illegally imported, because the import of a clone, as an adult or even as an embryo, would need to be licensed through the Importation of Embryos, Ova and Semen Order 1980. All the animals on which stories have emerged are the offspring of clones.

Chair : That’s helpful.

James Paice: We do have controls over clones themselves. Therefore, were one to be imported and licensed to be imported, we could impose the ban on that particular animal going into the food chain.

Q39 Chair : If you knew it was happening but, if they’re not traceable, how would you know?

James Paice: The answer is you can never be absolutely sure. They would actually be required-the animal or its embryo-to be licensed before it could come into this country.

Q40 Chair : In the case in Scotland, was that offspring?

James Paice: That was offspring; it was not a clone.

Q41 Chair : They didn’t apply for a licence.

James Paice: They didn’t need it.

Tim Smith: They didn’t need to.

Q42 Chair : They weren’t proposing to put the food in the food chain.

James Paice: You need a licence, permission under that order that I’ve just quoted, to import a clone into this country; in other words, something that has been created in a laboratory and then either imported into this country as an embryo, or implanted into a surrogate mother and that animal, as a result of that embryo, has been imported. You need to have our consent. Nobody to my knowledge has applied; certainly nobody’s got it. That animal can be clearly identified, and steps taken to prevent that animal entering the food chain. That’s clear. The animals that the debate has been about-the ones that have been imported-were firstgeneration offspring. In other words, a cloned animal was mated conventionally, probably by AI but relatively conventionally, with an uncloned animal, and its offspring came into his country. Then we have something like 85 nextgeneration.

Tim Smith: One generation on.

Lord Rooker: Can I just elucidate that, because it is important to have clarity here? Originally in 2007, DG SANCO said that the clones and the progeny should come under novel foods. That goes right back to EU 2007; that’s what DG SANCO said. That position is almost impossible to put into practice for the reasons we’ve explained. As Tim said, there are still legal m’learned friends, as it were, around Whitehall looking at it. The fact is the board has said that you don’t need a licence for the progeny of the clones to go into the food chain, but no one’s asked for one anyway, so you’ve got to distinguish. One of the papers-I don’t know if it’s one from Europe-talks about banning the clone in the first generation, as it’s like a buffer. That may or may not come about. You’ve still got to have a method of being absolutely certain what the first generation is, because at the moment we couldn’t tell.

Q43 Richard Drax: What concerns everybody instinctively is, to quote you, Minister, the phrase, "created in a laboratory". That’s the bit that really gets to the nub of it all.

James Paice: I appreciate that.

Q44 Richard Drax: You have these images of these fantastic pigs stomping around and their offspring, or whatever it is, are imported over here and then they breed from that and what that’s going to lead to. I think it’s really more of a statement than a question. What you’ve said is, if it goes wrong-if it does, like BSE and any other thing that happens in the food chain-we will not be able to tell which animal or which meat we’re eating is not healthy; correct?

James Paice: Whether it goes wrong or right, Mr Drax, the principles are the same. The issue is that the cloned animal itself, however it was derived, can be identified at the moment.

Richard Drax: I understand that.

James Paice: At the moment, they would have to be imported. That animal, you can pretty well guarantee, you can prevent from entering the food chain. The issue comes then with the subsequent offspring. The food safety aspect, which is the FSA’s responsibility, and you’ve heard their position on the animal welfare side and the food labelling side, is that is where it becomes very, very difficult, nay impossible, to identify verifiably that the meat or the milk has come from the offspring of a cloned animal.

Q45 Richard Drax: The answer to my statement is yes, effectively; we cannot tell, if it goes wrong, where the meat is, where it’s come from or what meat we’re eating is cloned, not cloned or whatever. There’s no way.

James Paice: No you can’t, but you would not be eating cloned meat if you mean meat from a cloned animal-a clone.

Q46 Richard Drax: From the offspring of a clone?

James Paice: From the offspring, the answer’s no.

Q47 Amber Rudd: Can you tell me what your rationale is for opposing the European Commission’s proposals for a fiveyear suspension of the use of cloning in agriculture and marketing of food products from clones? I understand that you have a different view from the European Commission.

James Paice: Yes, because we don’t see the evidence to justify that. We don’t believe EFSA has come forward with adequate evidence. As I said earlier to the Committee, we believe that, on the welfare grounds, the existing portfolio of legislation is adequate to address the welfare issues. On the food safety issue, EFSA itself says there’s nothing wrong with the food that is the progeny of clones.

Tim Smith: It does actually go against the evidence provided, which was requested by the Commission, from EFSA, in both 2008 and 2010.

Q48 Amber Rudd: The Commission’s view goes against this?

James Paice: Yes.

Tim Smith: The moratorium as a concept contravenes, effectively, the scientific evidence. It would be odd if our board took the view that the food needed to be banned on the basis of the science. Equally it’s odd that the Commission makes this recommendation of a moratorium based on EFSA’s opinion.

James Paice: Sorry, I should have made it clear that that’s the Commission’s proposals that we oppose. We don’t believe EFSA’s come up. The evidence is from EFSA’s report.

Q49 Chair : The European Food Standards Agency?

Lord Rooker: It’s the view of the FSA that that aspect of it is impractical anyway. They will have to come up with better scientific evidence, completely different scientific evidence from what they’ve got at the present time, so there’s no basis for that discussion. That’s why the Government have taken the view that they have. We advise in the sense of the food safety aspect, and the rest of the Government take a collective view, which we are part of at Brussels.

Q50 Amber Rudd: Would it be correct to say that your view was formed on the scientific evidence, rather than on the public feeling, so that’s why you might not have done a public consultation before forming your decision?

Lord Rooker: Yes, exclusively on the safety, but because of our statutory remit to put consumers first, which is in section 1 of the legislation, that’s why before our time at the FSA, the public consultation work was done. The board had not discussed this until September this year, but the board, of course, had done a private briefing of this Committee in 2008 and sent a paper to your predecessor Committee. It wasn’t as though nothing was happening or being discussed.

Tim Smith: Consumers, when we asked them the question about cloning, in much the same way as GM, said, "What’s in it for us? What are the consumer benefits? What can I derive from this? What happens as a consequence of cloning?" That doesn’t distract us from doing a proper risk assessment to give advice to consumers who want to know if it’s safe to eat this food. The only conclusion that we’ve been able to reach on the evidence we’ve got is it’s as safe as food that comes from traditionally bred animals and their progeny.

Q51 George Eustice: I just wanted to push a bit on this point about traceability. I know you explained in some detail that it’s potentially the progeny from embryos, rather than the embryos themselves, that is hard to track. When it comes to traceability, don’t you have this problem with everything, whether it’s freedom pork or free range eggs? There always has to be an element of trust in the farmer concerned. I don’t see why it’s necessarily more difficult than, say, the position for have a pedigree breeder of a particular herd of cattle who has to keep breeding records. Given that this is a very, very small section of the industry at the moment, is it not something that you could do to require those who produce embryos to keep those types of records in much the same way as a pedigree cattle breeder would need to?

Lord Rooker: Jim’s more involved in aspects of this, and Tim’s better qualified than me, but the examples you give are not very good. On free range eggs, you can technically check whether those eggs are free range or not. That’s why people are now in prison, because they’ve manipulated the market. In other words, you can technically tell whether an egg is free range or not. I won’t go into the details, but I’ve seen it done. In our case, the scientists can’t tell us whether the meat is from the progeny of cloned animals, although they could tell us what chemicals might be in it: we do 40,000 samples a year of meat, checking for veterinary residues and things like that, just as we do pesticide residues. All those checks are done anyway, as part of the policing of the food chain. If you get two sides of beef, you can’t tell whether one is derived from a descendant two or three times removed from a clone.

Q52 George Eustice: You could require the farmer to keep records.

Lord Rooker: I’ll give you an example. Even cattle passports, as Jim says, can’t be used, but there are no passports for pigs. There are no passports for sheep. We know we’ve got sheep in the food chain anyway, but there are no passports for individual animals.

Q53 George Eustice: To use another example, you picked eggs, okay, so there’s a technical one there, but for organic pork, for instance, you wouldn’t be able to check that against traditionally produced pork through a scientific test in a lab.

Lord Rooker: There’s a certification process for that.

Tim Smith: The accreditation process kicks in there.

Q54 George Eustice: Is it just not possible to have an accreditation process on embryos?

Tim Smith: It’s effectively an assertion, which is the same point that the Minister was making about retailers, that they must do their due diligence to be able to convince consumers-their customers-that they’re not being misled. Those retailers who are embarking on a clonefree or progenyofclonefree campaign need to be very careful. If we take the example from the August incident, as we refer to it, we know that we caught that at a particular moment in time when, as the Minister says, there are now 85 live cows, which could come into milk some time-probably in a year’s time. The next generation on from that would be impossible for all of us to track and trace. There would be no mechanism other than people telling us what had happened to the progeny of those animals. As you can imagine, that pyramid starts to expand pretty much exponentially. That’s the point at which we find it impossible to be able to give assurance to anybody, and there’s no need to, from a food safety point of view or an animal welfare perspective. There’s no point in doing it and there’s no way of doing it.

Q55 Chair : You did say, at the end of your board meeting, in the press notice that the FSA issued, "The board also noted the…Advisory Committee on Novel Foods and Processes’ view that it would be helpful to have further evidence on how the rearing of clones and their descendants in different environments may affect the meat and milk." Presumably you’re keeping this under review.

Tim Smith: Yes.

Lord Rooker: Yes, absolutely.

Tim Smith: The committee has a standing order now to review this on a regular basis.

Q56 Chair : You will update the advice on your website.

Tim Smith: When the advice that we get from the committee changes, then we change the advice we give to consumers and Ministers.

Q57 Neil Parish: I understand that with pigs there are no passports but, with cattle, if my memory serves me correctly, you put the sire in when you register the birth of the calf.

James Paice: It’s not compulsory. My recollection is that naming the sire is not compulsory.

Q58 Neil Parish: Very often, it would be the sire, because it would be the semen basically that was derived from a clone. You’re likely to clone a bull rather than a cow, very often, because you can use that semen. Surely it wouldn’t be beyond the wit of man to ask to have that registered when the sire is a clone, then you would know that was an offspring. I know it wouldn’t cover pigs but it would cover cattle.

James Paice: It is technically possible that the whole cattle traceability system could be adapted in that way, but I have to stress that the purpose of the cattle tracing system, which is based on European rules, as you well know, Mr Parish, was designed to protect human and animal health. As I think we’ve just explained very strongly, there is no justification to extend it beyond that. It also begs the question: how far do you go, how many generations? You put on the passport the firstgeneration sons of a bull. There’s nowhere on the passport to enter the grandsire or the granddam. I think there are some real practical issues here that have to be addressed.

Neil Parish: I have another question and I’ll pursue this, because there’s a sort of gene pool, but that’s a different issue. I’ll talk about that in a minute.

Q59 Chair : Before we leave the EU position-and you have robustly shared with us your views-presumably it’s you, Minister, who is making these points in the Council to the Commission and the European Parliament.

James Paice: Yes, on the Agriculture Council, but I suspect it will also go to the head Council.

Q60 Chair : Presumably the Department of Health will be making it on health or you at the FSA.

Tim Smith: Yes, exactly right.

Q61 Chair : What support are we getting from other Member States on our position?

James Paice: We haven’t yet engaged any.

Q62 Chair : Perhaps you’d be good enough to keep the Committee informed.

James Paice: Yes, of course.

Q63 Richard Drax: This is all very new, but do you agree that your previous stance for farmers to gain authorisation before selling food from the descendants of clones was illthoughtthrough?

Lord Rooker: No. As you can imagine, I’ve checked the background of this, being new in the Chair, and realising that the board, while it had had papers since 2007, had never actually had a discussion. The fact of the matter is we’d planned in June/July to have a discussion on cloning at our September meeting, before this incident we’re all aware of. We had given advice to new Ministers. We’d prepared the briefs: the red, the blue, the yellow. We didn’t do a blueyellow one, by the way, even though I did ask about that as a joke two weeks before the election. We put details about cloning into our big brief, which went to Health Ministers, because that’s how it went through to Parliament. We then produced a submission towards the end of June, which I saw and thought that the board ought to have a discussion about. At our September meeting, we had the Chair of the Advisory Committee on Novel Foods and Processes present at the board meeting to discuss this, on the grounds that they’d never had an application so had not looked at the process. You’ve seen our minutes of our September meeting. They went away and did a hypothetical application at the request of the board.

In the meantime, the second EFSA note came out. By the time we got to December, for our board meeting last Tuesday, the scientific evidence had changed, in the sense that we’d now got from our own Advisory Committee an issue relating to novel foods-the safety of the meat from the progeny of cloned animals. Because that evidence changed, because it was new, our stance changed. This is what happened last Tuesday, and the board made a rational decision. I know the lawyers in Whitehall are still looking around these issues, because, as I say originally, DG SANCO in 2007 said all the food down the chain ought to be classed under the Novel Food Regulations, and the FSA took that view. It was a commonsense view in the sense that the animal had been created, as Jim said, in the lab, and all the rest of them wouldn’t have been there if that animal hadn’t been there. The reality of the substantial normality of the food is such that, having got new scientific evidence between September and December, our stance changed. I don’t see the earlier decision as being a wrong one. Frankly, if we get new evidence, our advice to Ministers will change again. We will base it on the scientific evidence.

Q64 Richard Drax: Lord Rooker, you have said frequently that it’s not possible to trace the progeny of clones. That has been repeated. The FSA’s previous position, prior to 7 December, would require a farmer to get authorisation to sell food derived from the progeny of clones. What new evidence was presented to the board causing them to change their position?

Lord Rooker: First of all in September, as I said, we had a discussion about this for the September paper with the Chair of the Advisory Committee on Novel Foods. Because we’d never had an application, there’d never been an assessment, in terms of checking on this. The board put to Professor Gregory the need to do a hypothetical application, if you like. By the time we’d got to September, we’d had an assessment for the first time from the Advisory Committee on Novel Foods, and we’d had the second EFSA one as well. I make this absolutely clear: on the grounds that we could not trace and that we’d now got an assessment from our own independent scientific committee about the safety of the food and of the other products, basically food and milk, the board took the view that, as we couldn’t trace and that it was safe, therefore we would not, from our point of view, have the Novel Food Regulations cover the descendants of the clones. In effect, the reason, between September and December, was that we’d got new scientific evidence that we had not had previously.

Tim Smith: There were three ways in which our stance could have changed any time before the December board meeting. The courts could have been asked by a farmer or producer to say the UK was out of line with the rest of the EU. Any farmer or processor could have made an application to the committee for authorisation, and that evidence would have probably been sufficient to convince the board. Thirdly, and this is really important for the Committee to understand, we had made frequent applications, formally, to Europe through the Standing Committee on the Food Chain and Animal Health, to have this raised as an agenda item. While we felt it was unclear, and we were uncertain as to whether or not food from the progeny of cloned animals was a novel food, other Member States were taking positions entirely on their own. The Commission itself, as Jeff’s already hinted, had shifted its position sometime between 2007 and 2008. We found ourselves alone but with no evidence base. That’s why any one of those three methods would have caused us to pose a question to the committee. As it happened, the incident allowed us to pose the question to the committee, and they were able to give us a robust answer, which is now the subject of legal opinion around Whitehall as to whether we can actually shift.

Q65 Richard Drax: Can I ask you to come back to the farmer who did let this food product from the offspring of clones get through the system? He says, if I recall correctly, he didn’t know he’d done something wrong. Has information to inform farmers been disseminated downwards to ensure that everyone knows exactly what the rules are?

Lord Rooker: This goes back to this issue of the food business operators, which farmers are. They’re businesspeople running a commercial operation in the food chain; very important people, a very important operation. Let’s get that clear. It’s their responsibility to know what the law is. There is loads of law. I fully accept that it’s complicated, by the way. I’m not arguing this is a simple issue, but the fact of the matter is it was clear and upfront since 2007, on the FSA website, that cloning and the issue of clones would require novel foods, therefore it was known out there. He knew what he’d got, I presume. I’ve not talked to him; Tim’s actually met him. He knew what he’d got, so he knew he’d got something that was slightly different from the rest of the animal kingdom in the country. He could have applied at any time.

I want to repeat, by the way: it’s very important for those who are watching proceedings, there’s nothing wrong with someone having a novel food. It’s just the term given to a new product or a process. There’s nothing inherently unsafe about it or dangerous about it, but it does require, under EU legislation and UK legislation, that it be assessed, in the interests of food safety and other matters. That’s quite right for the protection of the public. It’s open to anybody. We’ve never had an application. The board had to take a view, having discussed it with Tim and the Chief Scientist, about what do we do about this. We put it to the chairman of the committee: can you do a hypothetical application, imagining there was a farmer, in general on cloning. That’s why we’ve restricted it, and been precise about this in terms of cattle and pigs, because that’s where the only evidence is in terms of food animals. It was open to the farmer to check. He could have asked through his trade association, trade union or whatever. They could have asked us and we’d have said, "Put an application in and we’ll do an assessment." Nobody did that.

The timescale of how the thing turned up in the International Herald Tribune is something I’m not really certain about. It was a bit weird. The fact is no harm was done in that sense. As I say, by the time that happened, the board in July-you can check this, it’s on the record-had discussed very briefly the fact that, in September, we wanted to discuss a paper on novel foods. We had to brief new Ministers on what the current situation is as opposed to Europe. As Tim said, the FSA has been pressing Europe since 2007 to get this definition sorted, because they’d changed, and we took the line of DG SANCO from January 2007. We’d been on the case that long. I can assure you, having gone through the files, all the papers, everything else and everything that’s available to you, it had not been a case of us being slow to come forward in that sense. It was all there on the website.

Q66 Chair : In this particular instance, I know ignorance of the law is no excuse, but the farmer didn’t think he’d done anything wrong, as Mr Drax suggested, and he did suffer a substantial loss. Presumably the cost of all the animals would not be recoverable.

Tim Smith: Why does he incur a loss?

Q67 Chair : I thought he had to slaughter all the animals.

Tim Smith: No. He has sold three bulls for the meat. One of those was not allowed into the food chain. That would be the only loss he’s crystallised in any form so far. What he chooses to do with the cows now they could be brought into milk is his next decision and that’s why we pressed him, when we met him before the September board meeting, to put an authorisation request in, because that would have allowed him to market that milk safely, in the knowledge it was legal.

Q68 Chair : Has he done so?

Tim Smith: No.

Q69 Neil Parish: Carrying on the discussion about animals other than pigs and cattle to be cloned, what assessment have you made of this? I noted that the EFSA update on animal cloning had limited data for animals other than pigs or cattle. What are you doing in order to look for that data or to check that it doesn’t become widespread in other animals, so you’re ready in case there is a lot of cloning of sheep or whatever?

Tim Smith: Both EFSA and our own Advisory Committee have noted that there is insufficient data to allow a hypothetical authorisation to proceed on other animals, particularly sheep and chickens. If there was to be an authorisation request from any producer, then there isn’t the scientific data, they say, at this stage, to allow us to make an opinion that would fall on the side of the food being as safe as that from traditionally reared animals. It’s only when you’ve got that evidence base that the food can go forward into the food chain. There hasn’t been an application here or anywhere else that I’m aware of for those foods to be considered under the Novel Food Regulations.

Q70 Chair : If there were an application, it would be perfectly legal.

Tim Smith: It would be legal to ask the question obviously. I suspect that, without going to back to our committee or to the European Food Safety Authority and asking them a direct question, they would say there is not enough evidence to support that food being approved. The absence of evidence wouldn’t simply allow that food to go through; they’d want to build an evidence base that said, under the following conditions, whatever the cloning technique, whatever the animal species, this food is now as safe as that from traditionally bred animals. There isn’t the evidence for animals other than cattle and pigs.

Lord Rooker: By definition, on that, there cannot be at the moment many generations of cattle and pigs from when the technique actually started, if one thinks about it. There can’t be many; certainly single figures, I would think.

Q71 Neil Parish: Probably pigs more than cattle, because they breed a lot quicker. Can I go on then to our other areas, for example the effect of the environmental conditions in which animals are raised, where the Advisory Council on Novel Foods and Processes said there was limited data on which to base their view. What assessment have you made of the data that you need to address their concerns, and what steps are you taking to commission any studies?

Tim Smith: They didn’t so much note that there were concerns. They were really reflecting the fact the data set that they’ve got is full enough to allow them to make a decision that the food is as safe as that from traditionally reared animals, but they would ideally have had a larger data set of different environmental conditions, I think specifically thinking about the way that pigs are reared in this country, to allow them to say that it makes no difference. Their assessment is, without any evidence to the contrary, that they’re satisfied to allow the approval to go forward.

Q72 Neil Parish: It was just the environmental conditions they were questioning, not the welfare conditions?

Tim Smith: Yes, exactly right.

Q73 Chair : Having listened to the arguments and the debate, what are the benefits to UK agriculture of allowing cloning to be used commercially?

James Paice: I’m very glad you’ve asked that question, Miss McIntosh, because I wanted to try to balance the argument. The Government do not have a particular pro or anti view. We have to be led by scientific evidence, but there are clear perceived advantages, because cloning has been developed in agriculture as a way of speeding up the movement of the best genetics through the livestock sector. In that way, it’s a further significant advance on AI, which was developed to do just that.

Those genetics could be very valuable: they could be about better welfare; they could be about animals’ resistance to diseases; they could be about significant reduction in lameness-a big problem in dairy cows; they could be about tolerance to particular diseases. The other benefit, which I don’t think we should exclude, is with regard to the rare breeds, because clearly it allows not just the spread of genetics but, in a perverse sort of way, it actually allows you to recover genetics, because the animal being cloned does not have to be fertile. It could be a castrated steer; it could be a female that is unable to breed, but you could still use its DNA through cloning. There are very clear potential benefits if this technology becomes sufficiently sophisticated to be used for it.

Q74 Chair : Would you agree with the NFU, which said that in its memorandum to yourselves that it was "unacceptable" that Britain could import products from countries where cloning technology was widely used, when this same use was prohibited domestically?

James Paice: As a general statement, the Government believes that it’s unfair to expect our producers to compete with producers from overseas who are allowed to use techniques, husbandry systems, chemicals or whatever that our farmers are not allowed to use. There are problems to do with WTO and EU rules that prevent you from banning some of those products. It’s quite clear to us as a Government that, if we were to ban the import of the offspring of clones, we would be entering almost certainly into a WTO challenge, which might be difficult to defend. I think in principle I agree. I haven’t seen the NFU’s submission, so I don’t want to give you absolute affirmation without seeing the whole thing, but I’m sympathetic to that point of view.

Q75 Chair : Did you indicate, in your last answer, that the benefits will be greater if we can develop the technology?

James Paice: What I was trying to get at was that, as we said in the earlier part of the discussions, the technology is developing all the time. It is, as somebody said, extremely expensive, so that in itself makes it a very selective technology, and the success rate is still quite low. If those problems are overcome, and we know that with all sorts of scientific advances these things are likely to be overcome, and therefore the technology could be more widely available, obviously the ability to use it for more purposes becomes more widely available. That’s all I’m suggesting.

Tim Smith: Can I just add, Miss McIntosh, that the Agency is entirely neutral on the subject of economics, because food safety has absolutely no bearing? We’re not influenced in any way on the success or failure of economic enterprises. We do not in any way sponsor the food industry; we’re there to protect consumers. We say that as often as we need to in order to remind people that we’re there to protect them and not to act on behalf of industry.

James Paice: Could I also add something, Miss McIntosh, just for clarity? I think I said earlier, when I referred to the issue of the legislation about the import of embryos, ova and semen, that I was not aware of any that had been imported. I should have added "from outside the EU". There has been a small amount of trade within the EU, from France, of cloned embryos for research purposes only.

Q76 Chair : Do you think the benefits will only percolate down if UK producers are able to sell the food from clones or the offspring of clones in the UK or EU supermarkets?

James Paice: If they were not allowed to sell the food product, I cannot see the purpose, other than possibly, as I’ve discussed, rare breeds. It would have to be a commercial judgment by the individual farmer, but I’m not sure they’d want to take it if they then couldn’t sell the milk or the meat.

Q77 Chair : If you’re successful in opposing the European Commission’s proposals, are you able to estimate how many UK producers would wish to use this cloned technique commercially?

James Paice: No, I’m not in the business of speculation like that.

Q78 Chair : Do you think, just from the answers that you’ve given, that the development of agriculture in this country is being hampered by the European Commission’s stricter line on food safety and animal welfare, or do you think we just have to wait for the evidence?

Tim Smith: Why did you think the European Commission was stricter on food safety?

Q79 Chair : I’m not saying on food safety. Are you saying the European Commission is saying it’s safe?

James Paice: You’ve just said it.

Tim Smith: You just said that.

Lord Rooker: You said that.

Q80 Chair : Right, but if the Commission was to get through these proposals or a mix of measures, they’re actually going to shut down any movement and any production.

Tim Smith: No, they’re proposing a moratorium, which only impacts on the clones themselves and the whole cloning process. It doesn’t impact on the progeny of clones. Say our farmer in Scotland wanted to market his milk and we’ve said it’s safe and DEFRA has given their opinion on welfare, the moratorium would not cover those food products.

Q81 Chair : Just to be clear, Mr Smith and Lord Rooker, earlier you said that if the Scottish farmer made an application, the milk or the product could only be sold under certain conditions where it was deemed to be safe. Do we know what those conditions are?

Tim Smith: No, I think the situation’s changed between the September and December board meetings. In September, we asked our Advisory Committee to go away and do a hypothetical assessment, because the farmer had not submitted an application. We’ve effectively done that on his behalf, and the board has changed its stance now to suggest that, assuming we can get through the legal situation that we’re in now, that food will be deemed to be outside the Novel Food Regulations, because we’ll effectively be coming into line with what is assumed to be the case around the rest of the world.

Q82 Chair : So it wouldn’t be safe?

Tim Smith: It has always been safe. It has never been a question of safe; it’s always been a question of legality.

Q83 Chair : So it could be sold?

Tim Smith: Assuming that the lawyers can agree that this is our new position, we’ll recommend to Ministers, as we have in our letter from Jeff to them following the board meeting, that subject to that legal opinion, milk and meat from the progeny of cloned animals be allowed to be marketed without going through that authorisation process. That’s new.

Lord Rooker: In other words, by the time those cows are into milk, which they’re not now, he can sell the milk without applying under the Novel Foods, providing there’s a willing buyer. That’s nothing to do with us.

Q84 Neil Parish: This is very much a question for Mr Paice really, and it’s one that is a pet subject of mine: the gene pool. If you take HolsteinFriesians, I think it’s probably argued now, even with using AI over the years, that the gene pool in HolsteinFriesians is almost plenty close enough, because you’re always breeding from the very best and of course you’re tightening that all the time. You always clone basically from your best cow or whatever, and it’s usually a bull, so that semen passes on. You have a cloned bull; you serve heifers with that semen; and then you decide to take the offspring of those heifers and put that semen of that cloned bull back on to that next lot of heifers. You’re actually bringing together a hugely close gene pool. Don’t you think that’s dangerous?

James Paice: Yes, I do, but I think you’ve answered your question yourself, if I may say so, Mr Parish, because it’s already happening under AI.

Q85 Neil Parish: It happens quicker under cloning in a way, doesn’t it?

James Paice: It may do, but I think the problem is already identified, and therefore with a lot of Holstein breeders-I can’t speak for them-my understanding is that a great deal of outcrossing is now taking place. People are bringing in bloodlines from different breeds- the British Friesian, Danish Red, Brown Swiss, Montbeliarde and various others; a number of different breeds are being brought in and crossed with Holsteins to get the hybrid vigour that we all learned about at agricultural college a long while ago. I think it’s happening anyway. I agree with you: in any breed, you mustn’t narrow down the gene pool too much, but that really is a commercial judgment that breeders have to take, and I think they’re waking up to it.

Q86 Neil Parish: None of us are against commercialisation, but some farmers may well take the view that the commercial benefit of keeping a gene pool extremely tight will get higher and higher, while producing cow that could cause lots of other problems with disease and other things, because of the tightness of that gene pool. While your answer to me was you recognise that, is there any need, I don’t say for rules, but at least for DEFRA to perhaps flag that up? Let’s be blunt about it, you can’t rely on everybody taking the same commercial decision. You’ve only got to see what they’ve been doing in the breeding of dogs and other things to know that you can get it really tight, and that’s what worries me.

James Paice: I agree with you that there’s an issue. I’m not sure, Mr Parish, that there is a role for Government in trying seriously to resolve the problem. My knowledge of what’s going on is that a lot of breeders are waking up to the problem, as I said. If somebody narrows down their gene pool or decides to use a very narrow bit of the gene pool, so that they have, for example, to cull half their cows each year-and there have been examples of that-that has a serious financial consequence for them, and that is why they are taking other steps. You referred to the issue of flagging it up. Perhaps this very discussion is doing that, but I don’t think it’s for Government to step in and say, "You can’t do this," simply to protect the gene pool of what is a commercial activity.

Neil Parish: No, I’m not suggesting that Government should act, but I’m just suggesting that perhaps Government can advise, can it not? It’s just something I feel very strongly about; that’s all.

Q87 Richard Drax: Are we justifying this on the grounds that the technology is there, or on the grounds that we have more people to feed in the world? What’s the justification for tinkering with Mother Nature?

James Paice: To be fair, Mr Drax, I’m not sure we are trying to justify. We are saying that we have to judge it on the role of Government and the powers and authority that different Government Departments have. From DEFRA’s perspective, the issue of welfare is the main one. Labelling comes into it, and we’ve debated that. Food safety is for the FSA. I don’t think it is for us to justify or unjustify. What I would say is that the Government are determined to be led by science and the evidence of science, and I think that’s come through in most of our comments this afternoon. If scientific evidence comes forward to give us a different picture on welfare, food safety or any other aspects of cloning, clearly the Government will have to react to it but, at the moment, all the scientific evidence is that there is no need for us to particularly intervene, other than in the way the FSA has described. I think that’s the right place for Government to be. I certainly don’t think Government should be snuffing out scientific advances unless there is very good reason to do so.

Chair : Thank you very much indeed. Can I thank the Minister, Lord Rooker and Mr Smith? Thank you very much indeed for being with us. If I can thank all the witnesses who have appeared before us through the year, and wish you all a very merry Christmas, a very big thank you to our excellent secretariat and my colleagues for their support, and a very happy Christmas to you all. We stand adjourned until 11 January.