Committee stage in the Lords
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Lord Winston (Lab)Labour- Quote
- My Lords, I will speak to Amendments 20, 22 and 23 in this group, with reference to Amendment 21. I am afraid that, much as I dislike it, I have a difference of opinion with the Minister. I want to make it clear at the start that this is not in any case an attack on his probity. I think he is completely honourable and honest, and is trying to do the same job that I am: to protect the environment and make certain that we do not release organisms that might be harmful to the environment. Noble Lords will remember that, when we finished on Monday night—it seems so long ago—unfortunately the Minister had to rush through a statement rather hurriedly and we did not complete our discussion of that statement. Since then, I have had a chance to go through the literature that I am concerned about. The first thing to say very clearly is that, in spite of the assertions in the advice that the Minister has been given, those assertions are not correct. In fact, there is a serious issue around the introduction of foreign DNA into an organism using gene-editing technology, particularly CRISPR and particularly CRISPR-Cas9, which is the commonest one that has been used in plants. Let me make it very clear that I do not in any way hold shame or blame toward the noble Lord, Lord Benyon. He is doing his absolute best in a very difficult area. As someone who has been practising genetics for over 40 years and doing modification of genes in various animal species, I find some of these concepts still complex myself. But from the publications on CRISPR technology—I will table a number of recently published papers, many of them not from Britain admittedly but from across the world—we can very clearly see that CRISPR leaves the organism vulnerable to the introduction of foreign technology. This has been particularly shown not only in the sort of animals I deal with, which are laboratory animals, but in the animals that we are most interested in in the Bill—farm animals, which are livestock. There are a number of publications that I could quote from, but noble Lords will have to forgive me because, although my notes are written in large print, I had an injection in my eye today so I cannot really see what I am doing. However, I can see with pleasure the Minister across the Chamber, smiling at me. I am smiling at him too, because it is not sensible to have an aggressive argument on this; this is something that we have to come to agreement on because we both agree that this whole business is for the public good. There were relevant publications from Crispo et al. in 2015, Kim et al. in 2015, Tsai et al. in 2015, Wang X et al. in 2015, Carey in 2019, Zou in 2019, Musser in 2020, and Zuccaro in the last year or so. Zuccaro is particularly interesting, having been working in a field that I am interested in, the human embryo, but this is a model for all mammalian embryos. There is no fundamental difference between those embryos and what we are saying about humans. Previous studies have found thousands of off-target mutations in gene-edited cells, embryos and animals. They raise the importance of investigating in-depth the gene-editing process and what it leaves behind. As the Bill stands at the present time, we would be at risk of releasing into the environment animals with changes in their genes which might be fundamentally different and in some ways damaging. For example—and this may sound ridiculous but I do not think it is at all—for the last two or three years, humans have been threatened by one of the most difficult viruses that we have come across: the coronavirus. We know that the virus was transmitted through animals—pangolins, probably, through the bat. Having been transferred through animals, it then changed significantly and damaged human health. This is a genuine and understated serious threat to human health. I do not think that it is likely, but it is possible and, at the very least, we must consider this very seriously and do everything that we can concerning the risks involved with the technology. As I described on Monday, there is no doubt that we might have problems with regard to making a herd that seems immune to one disease but, in consequence, is susceptible to another. That is seen very clearly in human health. For example, we know that, in places such as Sardinia and Cyprus, blood dyscrasia causes massive numbers of children to die, usually in their teens, from beta thalassemia. We could probably control this by gene therapy: we could change that gene to make people immune but, if we did so, they would then be vulnerable to another disease, malaria, which is likely to hit Sardinia with climate change and which kills over a million people a year. There is a real issue around how, if we change the balance of nature with these gene-edited animals, we might do things which we cannot calculate with any proper basis. I suggest that I table those papers for the Minister to look at, but I will refer to one particularly significant paper, Improvements in Gene Editing Technology: Boost Its Applications in Livestock. It is entirely on his side. I have chosen it because it is by authors who, like the Minister—and me, to some extent—favour this sort of work in livestock. I can leave this paper on the table, but I know I am not allowed to wave it—that is out of order in the House of Lords, but I am waving it anyway, because nobody is shouting “Order!” This paper is from a group of authors who are in favour of this technology, like we are, but who are also very concerned about the risks. They argue that more research needs to be done before we start to implement this, particularly in animals, in my case—I have insufficient knowledge about plant biology; I think I did S-level botany at school, but I was not a great botanist. I do not pretend to be a botanist, but I know more about animals, having worked with them for so long. I know that this is clearly something we can see in the mouse model we use, but also in another animal. I have chosen the pig, because it is one animal whose genes I have tried to change, using more conventional methods, and I know how unreliable that is. The same problems arise again and again. Let me try to explain the difficulty biologically. One of the problems is that CRISPR-Cas9 and various other technologies, in order to make the genome or animal more vulnerable to change, have to cause a double-stranded split in the DNA—a so-called DSB. That is how we insert or change the DNA that then becomes attached. That was one of the reasons why, on Monday, I asked the Minister whether he was concerned about the use of radiation and CRISPR together. One of the ways that mutations occur in humans, as we know from examples such as Hiroshima, is that X-radiation and gamma radiation cause these cuts in the DNA, which later cause cancer and other genetic abnormalities. It improves the chances of CRISPR working, but it may also result in making not only the advantages but also the disadvantages more likely to occur. I am saying with these amendments, in simple terms, that as responsible humans, politicians, scientists and revisers, we have to argue the delay of this technology until we have more data. This group of amendments clearly suggest to the Government that we would be derelict in our duty if we did not make certain that the animals we are releasing into the environment have the genome that we think they have but which we have not checked. My argument is that, to do this, we have to go through the laborious process of sequencing the genome of these animals before they are introduced. We also have to look at their phenotype. Of course, their phenotype may look normal, but underneath there might be things that are seriously threatening to the planet. That is our responsibility. The noble Lord is absolutely right—and I am grateful to him for saying this—that this is one area that we really understand in Britain. After all, we were ahead of the game when it came to sequencing the human genome and on the structure of genes. For example, Watson and Crick were at Cambridge. We have to recognise that this is a long tradition in our science. We can go on talking about Argentina, and the Argentinians have a very good reason for wanting to do this, as the noble Lord implied; not unreasonably, they want the commercial advantages. Correct me if I am wrong; there have certainly been some Nobel Prize winners from Argentina, but none in this field of molecular biology, unlike Watson and Crick, which is applicable. We have to recognise that this is something we work on very seriously in British universities, in a way that is not easily done in many other places. There is a great deal of expertise here.
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Lord Krebs (CB)Crossbench- Quote
- I thank the noble Lord, Lord Winston, for giving way. I also thank him for sending me a paper by Claire Robinson which makes many of the points he has just alluded to. I would like to ask the noble Lord a question. I offered the suggestion on Monday evening that the criterion for describing an organism as precision bred in terms of the Bill should not be that any exogenous DNA—which is what the noble Lord is talking about—should not code for a protein. That is what the Bill says in Clause 1(6). I offered an alternative, more stringent, criterion: that it should not have any effect on the phenotype. That is more stringent than saying that it should not code for protein because exogenous DNA could work on the phenotype in ways other than coding protein; for example, I mentioned gene suppression.
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- Lord Winston (Lab)Labour
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- I am very grateful to the noble Lord, Lord Krebs. As he knows, I have genuine respect for him, and rightly so; he is very distinguished in biology, and no one doubts that for a moment. His contribution has been, and continues to be, particularly important, as is his interest in the environment and its protection. But the phenotype can mean many things. The animals might be, apparently, phenotypically normal. However, for example, plants might turn out to produce as a result of gene editing some allergen—or possibly some toxin—that is completely unexpected but occurs in plants. Both of these could be damaging to human health even though the phenotype of that organism is normal. That is essentially the problem. It still means that that we have to be looking, as far as we can, for data. This is the key thing that we both want to see—I know that the noble Lord, Lord Krebs, is in favour of this because we have talked many times in different environments, particularly in the Science and Technology Select Committee, about how important it is. We have the ability to amass that data. The advantage of these amendments would be that this country would be supreme in doing this really well. We would be able to build up a databank of extraordinary importance. I do not think that answers his question in any way as, of course, there may be bits of DNA we miss. If you are doing CRISPR in a laboratory on a farm and are not using stringent precautions as we try to do in a human laboratory—in laboratory conditions under the Animals (Scientific Procedures) Act, for example, with a licence for the premises and person—you run a risk. For example, somebody coughing 30 metres away from a dish where CRISPR is being done could introduce human DNA. That human DNA would be completely random—off the skin or off the cough. It is a real issue which has happened. It happened when we were trying to do our original work deciding whether somebody had a fatal genetic defect way back in 1988. Therefore, we had to be very scrupulous. Again, the same problem arises; you could pick up those markers and see not what you would expect to see in a genome. I do not think it fundamentally changes the risk of introducing either organisms or bits—we talked about plasmids and other bits as well—of DNA which might arise. They are not simple; some of these are quite big chunks which can go in. Once you have taken the double-stranded break—which is what happens during CRISPR—the DNA is vulnerable to the introduction of foreign DNA that you do not expect or want and might express. That is one of the problems. Off-target mutations are another issue entirely, which is very clear from the literature. I spent a long time reading last night before going to bed to make certain I was sure of this. There are dozens of publications looking at mammalian DNA which show that off-target mutations, which are unwanted and may cover abnormal effects, would result in a fairly normal looking animal producing something we would not expect. That brings me to the next part of these amendments. I am afraid this is difficult with farm animals, because we are looking at long gestation periods. It is not like mice. With mice, we can do this within a month; in two months, we get two generations; in three months, we probably get three, more or less, because they have to get to sexual maturity. With mouse work, you can have several generations and you can get the same results. Actually, what we have to see is whether what happens with mice happens with farm animals, which seems highly probable. Their progeny, of course, are what is key to the success of this technology, ultimately—whether or not you can safely produce a herd. That is a fundamental difficulty with the Bill as it stands. This is not necessarily a bad Bill. I hope that we can help. In fact the noble Lord, Lord Krebs, and I have discussed this privately. Neither of us wants to delay useful technology that might help at a critical stage in our development as nations when we are looking at a big threat to the planet, but we could actually make that threat worse if we got this wrong. That is why I tabled Amendments 20, 22 and 23. I beg to move.
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Baroness Parminter (LD)Liberal Democrat- Quote
- My Lords, I rise with some trepidation to follow such an expert, but there is a reason why I am speaking on this: I have six amendments in the group. Three of them deal with one issue that follows on quite neatly from what the noble Lord, Lord Winston, has just been talking about: to ensure that the Bill deals with the necessity of data banks, storing the necessary information about the clinical outcomes for both the animals used in the gene editing and their progeny. I will therefore speak first to my Amendments 24, 44 and 45, which all deal—probably in quite a clumsy way, but nevertheless a way to put this on the face of the Bill—with a requirement for a continuing record of clinical outcomes for the adverse and other effects on both the animals used by gene editing and their progeny. I am grateful for the support that I have had in tabling this amendment from the British Veterinary Association, particularly Professor Madeleine Campbell, who has been invaluable. I draw noble Lords’ attention to the parallel piece of legislation, the Human Fertilisation and Embryology Act, in which there is a requirement for the surrender of ongoing records containing the information about the impacts—both positive and adverse outcomes—on those individuals used under the terms of that Act. Indeed, there are stringent requirements in the Bill, subsequently set out in regulations, that make it clear that those have to be ongoing records for 50 years, because of the potential length of impacts on the progeny of the people involved in those medical interventions. Given the importance of this new field of gene editing, we should ask for a similar requirement—certainly mentioning on the face of the Bill that an application to undertake gene editing must include plans to submit to the Secretary of State a continuing record of those outcomes. In the case that I just mentioned, the Secretary of State can make that information available for medical research. I argue that there needs to be a similar requirement for the Secretary of State to do so in this case. That is why, in my Amendment 24, I use the words, “supply such records and other required information to the Secretary of State”. This is specifically on that point, so that the information can be made available publicly for further medical research by veterinarians and others, to ensure that we get the benefits for the welfare of future animals. I do not want to say too much more at this stage, because I have a number of other amendments, but I thank the noble Baroness, Lady Hayman, for supporting me on this. Sadly, the noble Lord, Lord Trees, is not able to be here today, but he has indicated to me that he is supportive of such an amendment, and if I were to bring it back on Report he would indeed support it. I therefore move on swiftly, so as not to detain the Committee too long, to my Amendment 50, which deals with the equally critical issue of the animal welfare advisory body. This is somewhat scantily referred to in Clause 22, which gives the Government the power under the negative procedure to say through regulations what this advisory body will do. This is a fundamentally important body, particularly for those of us concerned about the use of animals in gene editing. I seek to set out in this amendment some clarity about the role and membership of the body. I have tried to include experts beyond just those who have expertise in gene editing, to ensure that it is transparent and has some purchase with the general public with the inclusion of a lay member, and to ensure that it has sufficient budget and resources to do its job. I was pleased that the Constitution Committee raised significant concerns about the scantiness of the information available about the animal welfare body and the need for greater transparency on this front. During the passage of the then Animal Welfare (Sentience) Bill, there was a similar degree of scantiness—I think that is the right word—about the committee that was meant to oversee that area. This House was able to persuade the Government of the case for putting more information about the sentience committee in that Bill. There is a parallel case for doing so here. It would give Members of this House, and, more importantly, the general public, far greater confidence about this important body. Again, I am grateful to the noble Baroness, Lady Jones of Whitchurch, for supporting me with this issue. I move swiftly to my remaining two amendments, which follow on. Amendment 36 deals with the scope of the welfare advisory body. At the moment, the scope seems to suggest that this body can focus only on issues that have been raised by the notifier on the potential impacts on the welfare of the animals, not that it can go beyond those parameters to look at the wider risks that might reasonably be expected to be possible issues that might come up for the animals and their future progeny. With Amendment 36, I seek to say that the scope of the welfare advisory body’s concern should be broadened so that it can focus on issues that would “reasonably be expected”, rather than just on the issues that the notifier has given. I am sorry for detaining the Committee for so long. As a follow-on to that amendment, my final amendment again picks up the point about the issues that ought reasonably to be thought about in terms of their effect on animals. I have noted those areas that ought to be in the Bill for the Secretary of State to think about, given that they are commonly adverse effects from selective breeding. It is therefore a reasonable expectation that this would be the case in gene editing as well. However, I make it clear that I am not proposing that the amendment should limit the scope of the factors; they are just some of the ones that should be included. It does not preclude the Secretary of State’s right to go broader than that. The Delegated Powers and Regulatory Reform Committee was critical of this issue—how loose Clause 25 was in leaving matters to regulation that should be in the Bill. With that, I will sit down and be quiet.
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Baroness Hayman of Ullock (Lab)Labour- Quote
- I have a number of amendments about the animal welfare advisory body, so it probably makes sense if I introduce mine next, if noble Lords are happy with that. I thank the noble Baroness, Lady Parminter, for that introduction. I was very pleased to support her amendments. I have a number of amendments in this group relating to Clause 12, which lays out details on the reports that the welfare advisory body will be required to make in its consideration of an application for a precision-bred animal marketing authorisation. It states that the welfare advisory body will have to determine whether the notifier, in its animal welfare declaration, has paid regard to the risks to an animal due to a precision-bred trait and whether the notifier has taken “reasonable steps” to assess those risks. That is fine, but our concern is that it does not have enough detail. That is why I tabled my amendments.
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Lord Cameron of Dillington (CB)Crossbench- Quote
- My Lords, my Amendments 35 and 40 follow on neatly from the remarks of the noble Baroness, Lady Hayman. As I mentioned at Second Reading, there is no doubt that the gene editing of animals will allow us to do some real good in the animal kingdom, in a way that would otherwise take decades of trial and error, through random mutations and with hundreds of field experiments having to be eliminated. Equally, it is just possible that some breeders might see this as an opportunity to breed animals that can better tolerate the cheap and inhumane conditions these breeders might see as a shortcut to greater profit. In my view, it goes without saying that no real farmers think like this. There is no reason to suppose that gene editing should lead to bad breeding more than the random mutations that have gone before. However, as I said at Second Reading, if we are making it easier to make changes in breeding practices, let us take this opportunity to ensure that we promote only the best traits and that our animals and their progeny do not suffer in any way as a result of either them or their descendants being bred to survive poor husbandry. The same applies to companion animals. We do not, for example, have a very good record on what we have done to the wolf: breeding ever smaller dogs; dogs that can hardly breathe because of their squashed noses; dogs whose eyes sometimes fall out of their sockets; and dogs who are bred for their bad tempers and fighting ability. All are not good examples, which, to my mind, we can well do without. So we want to make sure that this welfare advisory body, whoever it may be, has specific responsibilities to examine the future quality of life of any relevant animal and its future progeny in the long term—both in the home and on the farm—and not to issue a licence if there is any risk at all that the genetic changes being proposed could result in future discomfort or distress to the relevant animal or its progeny. I hope that my two amendments, ensuring the broadening of the remit of the welfare advisory body on the face of the Bill, will be sufficient to prevent the possibility of a blinkered approach by this so-called welfare advisory body. While I am on my feet, I want to touch on Amendment 50 in the name of the noble Baronesses, Lady Parminter and Lady Jones. It very much goes along with my thinking, because it seems to me that the clauses relating to the treatment and breeding of animals do not aspire to be effective legislation. The noble Baroness, Lady Parminter, used the word “scanty” or “scantiness”; “wishy-washy” was the adjective that came to my mind. In particular, the make-up and role of this welfare advisory body leave a lot to be desired. There are no real details as to who might be on it, what its budget might be or the full extent of its powers. In thanking the noble Baronesses, I hope that, even if he does not like the details of this amendment, the Minister will agree to meet a few of us before Report to thrash out some sort of government commitment to getting more detail about this welfare advisory body in the Bill.
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- Lord Winston (Lab)Labour
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- Before the noble Lord sits down after his useful contribution on animal health, I want to ask him this: does he agree that one of the problems with many animals is that, in the same species, you often have some animals that are docile and happy with their environment and some that are quite aggressive and difficult to manage? That is one of the problems with simply having regard to the pheno- type of the animal—how it looks and so on. These things are sometimes quite difficult to gauge. It seems probable to me—this is almost certainly true in human genetics—that the temperament of an animal is part of what the noble Lord is talking about and is therefore one of the issues we must take into account when considering the effects of the Bill. I do not know whether the noble Lord wishes to comment on that.
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- Lord Cameron of Dillington (CB)Crossbench
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- The comment I would make is that I am asking for long-term surveillance of the results of gene editing, in the same way that we should have had long-term surveillance of the random mutations in the ordinary, traditional basic breeding that goes on at the moment. To pick up on what the noble Lord seemed to be hinting at a few minutes ago in some of his remarks, I do not think anyone is suggesting that any gene editing goes on in any farming environment. No gene editing is going to go on except in a laboratory under really strict conditions, as I see it. If you talk to the gene editors and breeders who are already doing this sort of science, they will tell you that no animal is released from a laboratory or from laboratory conditions for at least two or three generations down the line before it goes on a farm. I noted what the noble Lord said about that, and I do not think there is a danger of someone coughing 50 yards away, as he mentioned, on a farm—but maybe that happens in a laboratory as well.
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- Lord Winston (Lab)Labour
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- I wish that were true of human in vitro fertilisation sometimes—although of course the HFEA as a regulatory authority has done a great deal to improve that. Early on, there were people who used to boast about being able to do in vitro fertilisation in a broom cupboard. That is quite an interesting issue.
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Lord Rooker (Lab)Labour- Quote
- My Lords, I shall say a few words about Amendment 54 in my name. Basically, all the amendments in my name are a result of the report on the Bill from the Delegated Powers and Regulatory Reform Committee. Amendment 54 relates to the fact that in Clause 25(1), there is a power to “prescribe circumstances in which the health or welfare of a relevant animal … is … to be regarded … as being adversely affected by any precision bred trait.” The amendment questions what “adversely affected” is all about, because the Bill is not clear. Clauses 11 and 15 use this phrase when the applicant is applying to the Secretary of State and the Secretary of State can make the decisions. The report on the Bill from the Delegated Powers Committee accepts that the affirmative procedure is involved and the memorandum provides the justification for the power of the Secretary of State to decide whether an animal is “adversely affected by any precision bred trait.” But the committee called the memorandum “vague and inadequate. Where the Government propose that an important term used in a Bill is not to be defined in the Bill itself but is instead to be defined subsequently in ministerial regulations, we expect a convincing justification for this. In our view, what is meant by the health or welfare of an animal being ‘adversely affected by precision bred traits’ for the purposes of the Bill is not a ‘technical issue’—and the Government themselves acknowledge this in the Memorandum.” In short, the committee’s report states in paragraph 29 that “defining the circumstances in which the health or welfare of an animal is to be regarded as ‘adversely affected by any precision bred trait’ for the purposes of the Bill is significant in policy terms and is a matter of public interest; it is therefore important that any such definition is subject to an appropriate level of parliamentary scrutiny; leaving the definition entirely to ministerial regulations (albeit subject to the affirmative procedure) therefore demands a convincing justification; the Government have failed to provide this; and accordingly, unless the Minister can provide the House with a convincing justification for it, the power in clause 25(1) is inappropriate.” This amendment gives the Minister an opportunity to tell us what is meant by “adversely affected by any precision bred trait.” It must not be kept a secret. It has got to be open and transparent so that people understand it.
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Baroness Jones of Whitchurch (Lab)Labour- Quote
- My Lords, I will rise very briefly because I have added my name to Amendments 50 and 87. I very much support the comments that have already been made by the noble Baroness, Lady Parminter, and my noble friend Lady Hayman, in proposing those amendments. I do think that—this has been a bit of a running theme, really—the lack of information about the composition and functions of the welfare advisory committee, which was flagged up at Second Reading and has again been flagged up quite widely today, is important. It is also important for us to really understand how the functions of that body will relate to other committees that are already in existence or envisaged in other bits of legislation. They will not stand alone in isolation: we need to know how they will interrelate.
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Baroness Bennett of Manor Castle (GP)Green Party- Quote
- My Lords, we have already had a full, detailed and rich explanation of this rather large and very important group. I will make a couple of short points. I would not presume to seek to add anything to the master class we had from the noble Lord, Lord Winston, covering his early amendments in this group. All I would suggest is to cross-reference; this is a debate we started on Monday, and I think it would be useful if we looked at the two debates together, because they address different parts of the Bill but the same crucial issue of exogenous DNA. As for the broom cupboard or farmyard question, just because a technology is widely available—and the reality is that a lot of this technology is now becoming widely available and relatively cheap—does not mean it should be used widely and by people in broom cupboards, for example. The amendment from the noble Baroness, Lady Parminter, about appropriate records is crucial. As the noble Baroness was speaking, I was thinking about the recent, grave concern about large amounts of peer-reviewed research, for which a condition of publication from the journals is that the data and the raw data have to be deposited in places where people have access to it. The data is there, but when people go and look for it, they find it is not available. If people cannot get access to that raw data, there are immediately grave concerns about the final conclusion being presented without that data. So it is crucial that it is available. The noble Baroness, Lady Hayman, spoke about the animal welfare advisory body. The amendment here says that the body should rely not just on the evidence presented to it but think independently about what other problems might arise. In other contexts, we have been talking about the green revolution and the problems it has caused, and the state of our soils, water and health now. We have seen what happens when commercial interests are able to set the direction in which our agriculture and science go. It has got us to the point we are at today. That critical, independent assessment is crucial.
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The Minister of State, Department for Environment, Food and Rural Affairs (Lord Benyon) (Con)Crossbench- Quote
- My Lords, I am grateful for what has been a fascinating debate. I am conscious that there is in this Room a fellow of the Academy of Medical Sciences, who is also a fellow of the Royal College of Physicians, and the Royal College of Obstetricians and Gynaecologists, and others who are fellows of the Royal Society and winners of the Frink Medal—and that is just two of them—and that my attempt at a biology A-level sits me down at the other end of the spectrum. I will endeavour to answer the points that were raised. The noble Lord, Lord Winston, made an important contribution to this debate. First, I say to him that the references to CRISPR Cas-9 are not relevant to this legislation. I know that he knows this, but he makes an analogy to that. Important though it is, it is specifically outside this legislation. Independent scientific advice from ACRE, the Advisory Committee on Releases to the Environment, is that precision-bred organisms pose no greater risk to the environment and health than traditionally bred organisms. That advice is supported by the Royal Society, the Royal Society of Biology and the Roslin Institute. Professor Lovell-Badge from the Crick Institute reminded us that: “Generally, on the risk of a random mutation versus a genome-edited one, you are actually better off with a genome-edited one because you know what you are doing.”—[Official Report, Commons, Genetic Technology (Precision Breeding) Bill Committee, 28/6/22; col. 37.] This was supported by Professor Houston, director of innovation at Benchmark Genetics, who told us that it is now getting very good data from research experiments showing that off-target effects are very rare. In summary, our advice has been that there is no increased risk to health and the environment. My commitment today is absolutely to study the papers that the noble Lord mentioned and to assure the Committee, including the noble Lord, Lord Cameron, who made a very important intervention, that we would be happy to meet. I repeat that invitation; some noble Lords have already met me, the Bill team and others who are advising us to make sure that we are addressing their concerns and that we reflect that in any changes that we want to see to make sure that this works. In my response to the amendments in group 8 I will cover our thinking on the provisions for release into the environment and the marketing of precision-bred animals, including animal marketing authorisations. I will start with the amendments on the interplay between this Bill and the Animals (Scientific Procedures) Act 1986, commonly known as ASPA. I reassure noble Lords that ASPA will apply during the first stages of developing a breeding line using precision-breeding techniques in animals. ASPA rightly places rigorous requirements on the use of animals in scientific procedures, including precision breeding. ASPA requires that animals may be used in science only where there are no alternatives, where the number of animals used is the minimum needed to achieve the scientific benefit, and where the potential harm to animals is limited to that needed to achieve that benefit. I know that they are the values and priorities that the noble Lord, Lord Winston, will have operated under through many decades of research. We will of course continue to work closely with the Home Office, which regulates these matters, as we develop guidance on this issue. As I said on Monday, we have also commissioned Scotland’s Rural College to carry out research which will provide further information on how breeding lines are developed using precision breeding, including the stages which would be covered by ASPA and this legislation. This research is due to complete next summer and will be important in helping us produce guidance outlining when and how these two pieces of legislation will apply in the process of placing a precision-bred animal on the market. I reiterate what I said on Monday: our priority is to develop these new technologies in plants first and then, as we get the structure, framework and architecture right, we can proceed with animals. In relation to Amendments 23 and 72A, I reiterate that ASPA licences will be needed for scientific procedures for precision breeding in animals, as defined in ASPA. Under ASPA, three licences are required: a personal licence for each person carrying out procedures on animals, a project licence for the programme of work, and an establishment licence for the place at which the work is carried out. I hope that addresses the concerns about broom cupboards—we want to make sure that this is taking place in registered, agreed, regulated premises. Furthermore, the Bill will not make changes to the way precision-bred animals are regulated under the existing Genetically Modified Organisms (Contained Use) Regulations. This means, among other things, that facilities where precision breeding takes place must be registered with the Health and Safety Executive and comply with the requirements to apply appropriate containment and control measures. Both of these regimes work effectively to ensure precision breeding is conducted in a known premises or laboratory, under suitably regulated conditions. I turn now to Amendments 20 and 22. Clause 3 applies to the release of plants and animals which will be primarily for research purposes. The ASPA regime already works effectively to protect animals used in science and research, so although I understand the intention, I do not think it would be appropriate to insert this further requirement here. Furthermore, developers will already be required to submit a release notice to Defra confirming that the “founder” organism they intend to release for research trials meets the criteria set out in the Bill. They will have generated genomic data in order to confirm that this is the case. However, requiring the information set out in the amendment, including epigenetic data, would be disproportionate.
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- Baroness Bennett of Manor Castle (GP)Green Party
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- The Minister addressed the point about changing the traits of animals through gene editing to make them perhaps more tolerant of crowding and more able to cope with disease, filthier conditions and conditions that do not meet their behavioural needs. He said that in the UK there is the protection of all our animal welfare legislation. I will park to one side whether I think that is adequate or not. Does he acknowledge that, while the Government talk about developing a British biotechnology industry, so-called precision-bred animals produced under this legislation are very likely to be exported and then farmed in conditions that are not covered by UK welfare law—and, indeed, often under far worse welfare law and in far worse conditions?
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- Lord Benyon (Con)Crossbench
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- Animals are bred in this country through traditional means, and some of those traits may make them more resilient to higher stocking rates than we would allow here. We have no sovereign ability to control what other countries do, but we can put pressure on them in a variety of different ways. I do not see any philosophical, moral difference between what the noble Baroness says and what exists today. We are talking about similar means of improving the quality of animals and plants as we are doing through traditional processes. So the noble Baroness’s point, although valid, is absolutely not one that we can consider in terms of legislation in this country. If I have understood her right, that is the situation in which we live.
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Baroness Browning (Con)Conservative- Quote
- Conversely, following on from what the noble Baroness, Lady Bennett, has just said, what about imported animals? How will they be assessed in terms of the legislation before us?
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- Lord Benyon (Con)Crossbench
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- Currently, the importing into this country of animals that are subject to this kind of technology has to be done through our GMO regulations and laws, and that is what we are seeking to change. The other point is that we may be breeding things that will be of huge advantage to other countries. We may well be giving people in countries that are developing, and particularly vulnerable to climate change, the ability to survive and prosper in ways that they could not have done without the technologies that we will be giving them. So I think it is a glass-half-empty approach to look at it in terms of what other countries could do with animals that are improved because of what we do, rather than thinking of what the benefits could be for other communities around the world.
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- Lord Winston (Lab)Labour
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- Well, it has been an interesting debate. As I promised on Monday, I will not have an exaggerated summing-up on this issue. One cannot deny from the literature that there is still a huge amount of unpredictability and uncertainty about some of the mutations, particularly the off-target ones, and the vulnerability of the CRISPR technique, which is still probably the best one that we have; TALENs and zinc finger nucleases are not as effective. However, that efficiency should not prevent us understanding that there are mistakes that occur during the technique. We need to discuss that and look at it in detail. A difficulty that I have, and I think probably we all have, in this debate is that the rules of what we do in this House depend on the scope of the Bill. We have a very tricky issue here because, according to the Bill and how it is seen by many of the people running it, the scope of the Bill is the release of organisms. But, without looking at the science as well, what happens before the release of the organisms is critical to this. For that reason, I think both the Minister and I are at something of a disadvantage, because we cannot table sensible amendments that really cover that—and it is of course a Defra Bill. I do not intend at this stage to discuss some of the points that the Minister has made in detail. I just think that there is enough uncertainty, as shown in so much of what I have said, that we need to have that discussion and work out who is advising us. He mentioned a number of authorities, such as some of the royal colleges—noble institutions, of which of course I am also a member—which argue that these positions are safe. I am not quite sure on what basis they are saying that or who advises the people who give out that information, because many of them will not necessarily be involved in this technology, which is so specialised. That is not to rubbish the people who are advising anybody, but I think it shows that there is a cloud around some of the issues that we are getting through. What is undeniable is the wealth of publications that we have. For example, this publication by Carey, which incidentally seems to be funded and supported by the State of Virginia in the United States, is clearly in favour of trying to genetically modify pigs. One of the issues we always had with pigs when we did a bit of work on them in my laboratory was how difficult it was to manage a lot of the manipulations that we were doing. It is very clear that with pigs, for example, there is still considerable unpredictability in which part of which GMO is sometimes affected by the way the CRISPR is constructed. So we need to talk through a lot of issues to make this a sensible and safe procedure. Nobody in this Chamber, unless they are very foolish, wants to try to strangle an important technology—people like me would not be working in it. Obviously, ultimately, we want to see it used in human science as well, not in modifying humans, but certainly in doing things in human medicine; not in the germ line, but certainly in the somatic cell line where you have much more control. There is clearly a very big difference there. We are not looking to make super-races, or anything like that, but it is an issue that needs to be looked at. For the moment, I beg leave to withdraw my amendment.
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- Lord Benyon (Con)Crossbench
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- I just reaffirm the point I made right at the beginning, which is that I would very much like to get the noble Lord, Lord Winston, and any other noble Lords together with the scientists and others who are advising us and to drill down on some of these issues before we get to Report. I have a Defra scientist’s voice in my head saying, “I see your scientific paper and raise you mine”. There are many coming from lots of different directions. Not all scientists agree, as noble Lords will know, but there has to be a body of opinion on which lay men like me—like most Ministers—have to take a balanced view. I assure him and others that there are no state secrets here. We need to make sure that we are working on this, and I make that offer.
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- Lord Rooker (Lab)Labour
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- My Lords, I shall take Amendments 25 and 30 together and also speak to Amendment 43. I am raising tonight only the issues in the 19th report of the Delegated Powers and Regulatory Reform Committee. I will not go into detail, but Clauses 4 and 6 give powers to prescribe information that must be provided to the Secretary of State by a person who wishes to release or market a precision-bred organism. Clauses 3 and 4 impose conditions restricting the release, including the requirement to give a release notice to the Secretary of State accompanied by any required information. Paragraph 10 of the committee’s report states: “The ‘form and content’ of release notices and marketing notices and the ‘required information’ that must accompany them is to be prescribed in regulations made by the Secretary of State”. Paragraph 11 of the report states: “By way of justification for these powers, the Memorandum simply asserts that each power ‘allows the Secretary of State to deal with administrative matters’”. The committee said: “We accept that the form that release notices and marketing notices are required to take might fairly be described as an ‘administrative matter’ but the same cannot be said about the content of such notices and the ‘required information’ that must be submitted with them.” It went on to say in paragraph 13: “Accordingly, we find it surprising that the Bill itself says nothing at all about what that information should comprise and instead leaves it entirely to ministers to decide—and in regulations subject only to the negative procedure.” The conclusion of the committee was set out in paragraph 14: “We consider that: the information that those who propose to release or market precision bred organisms are to be required to provide to the Secretary of State about this in a notice under clause 4 or 6 is a matter of significant public interest given that decisions about whether to permit such release or marketing will be based on that information”. The committee felt that, so far, “the Government have failed to justify the inclusion in those clauses of powers that leave it entirely to ministers to determine what that information must comprise—and by regulations subject only to the negative procedure”. The committee is really asking the Minister to the provide this Committee with a convincing justification for the delegation of power in Clauses 4(3) and 6(2). I will make a few brief points about Amendment 43, which relates to Clause 18(1) on the power to prescribe information that must be included in the precision-breeding register. The matters about which the register must contain information are release notices under Clause 4, marketing notices under Clause 6, reports provided to the Secretary of State by the advisory committee under Clause 7, reports provided to the Secretary of State by the welfare advisory body under Clause 12, notices given by the Secretary of State under Clauses 8 and 13, and enforcement notices. Paragraph 20 of the committee report states: “However, the information that the register must contain about these matters is left to be prescribed by the Secretary of State by regulations subject to the negative procedure.” The delegated powers memorandum supplied with the Bill by the Government attempts to provide some of the information but, at paragraph 22, the committee found “this an unconvincing explanation for there being nothing at all on the face of the Bill about the information that the register must contain about the matters in question and for this instead to be left entirely to ministers”. The committee therefore concluded that “the substance of the obligation that is to be imposed on the Government to keep a public ‘precision breeding register’ as a means of delivering transparency … is an important matter of public interest; a key aspect of the substance of that obligation is the information that the register will be required to contain about the matters specified in clause 18; it is therefore important that provision prescribing that information is subject to an appropriate level of parliamentary scrutiny”. The committee felt that “leaving it entirely to ministers to prescribe that information by regulations therefore demands a convincing justification”. So far, “the Government have failed to provide this; and … unless the Minister can provide the House with a convincing justification for it, the power in clause 18(1) is inappropriate.” That is basically the submission of the Delegated Powers Committee on these three points, which I am happy to put to the Committee and to the Minister.
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Baroness Bakewell of Hardington Mandeville (LD)Liberal Democrat- Quote
- My Lords, the noble Lord, Lord Rooker, made a powerful speech far more eloquently than I could emulate. Unlike other contributors to the debate, I have inadequate experience in this field. The public register is an important element of moving forward on genetic technology. Last time this was debated, there was wholesale opposition from the public and some local authorities. I remember the demonstrations in Somerset against GMO crops being grown in undisclosed locations and the fear that organic crops would be contaminated. Having a readily available public register of what licences have been granted and where they are is key to keeping the public on board.
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Baroness Wilcox of Newport (Lab)Labour- Quote
- My Lords, we are grateful to the Delegated Powers and Regulatory Reform Committee for its report on the proposed powers in the Bill, and to my noble friend Lord Rooker for tabling and introducing this first batch of amendments reflecting that committee’s concerns. Almost every Bill brought forward by this Government appears to be framework legislation, with only the bare minimum included in primary legislation and almost all the detail left for an ever-increasing body of regulations. It is neither efficient nor practical, and could give rise to a crochet blanket of loopholes in our legislative framework. This House’s Constitution Committee and Delegated Powers Committee have been fighting the good fight for many years, pushing back on this practice, but Ministers unfortunately do not seem willing to listen or act upon wise counsel. We understand that the Government wish to legislate in this area, ensuring that the UK remains competitive as other countries explore the development of these new technologies or regulate for their rollout. The Minister knows that we support the passage of the Bill, but that does not mean that we think it acceptable to leave so many parts of it essentially unfinished. On Monday, the Minister sought to reassure colleagues that nothing will happen before we are in the right position to do it. Yet here we are, considering skeleton legislation that will require an unknown number of SIs, over an unspecified timescale. The powers flagged by the noble Lord, Lord Rooker, would all be exercisable under the negative procedure, but if we are to ensure political consensus and public buy-in, should Parliament not have a formal role in approving the finer details of release and marketing notices? At the very least, is Defra able to publish additional information ahead of Report? This could be a more detailed policy statement, or indicative regulations reflecting the department’s current thinking. It would certainly give reassurance that the devil is indeed in the detail.
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- Lord Benyon (Con)Crossbench
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- My Lords, like other noble Lords, I thank the noble Lord, Lord Rooker, and other members of the Delegated Powers and Regulatory Reform Committee, for their work on this report. I entirely support the noble Baroness, Lady Wilcox, in her assertion that we must, wherever possible, try to achieve political consensus and public buy-in, as she put it. I am grateful for the generally positive views across the Chamber on this Bill and our attempts to ensure that we are getting this right. I have listened very carefully to what noble Lords have said. We are considering the committee’s recommendations. The Government are drafting a response to the DPRRC report, and we will publish our full response, in the usual way, way ahead of Report. In the meantime, I will take this opportunity to set out some more detail around taking these powers and how we intend to use them. We expect that, when Clause 4 is brought substantively into force, the content and information required in a release notice would be the same as that in the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022, which Parliament agreed under the affirmative procedure earlier this year. However, precision breeding is a rapidly developing area. Indeed, we hope that the Bill will stimulate domestic research and development in this field. It is therefore important that we can adjust our requirements for the form and content of the notice and any accompanying information. Any updates to requirements are likely to be technical or administrative and are needed, for instance, to keep pace with technological developments. The regulations I mentioned, which enabled qualifying higher plants to be released provided the requisite notice has been given to the Secretary of State, have been in place since April 2022. Various research institutes have already taken advantage of this legislation to inform the Secretary of State of their qualifying higher plant releases. For the marketing of a precision-bred product, a different notification would be required, as this will need to contain detailed technical information that enables the advisory committee to provide a report to the Secretary of State on whether it considers the organism to be precision bred. The criteria for this assessment are already laid out in Part 1 of the Bill. For example, descriptions of any genetic features resulting from the application of modern biotechnology and their stability will need to be provided. As with the release notice, we will need to be able to make technical and administrative adjustments to reflect technological developments. I turn now to the amendment to Clause 18. This amendment would remove the provision on setting up a register, so there would be no requirement for a public register of precision-bred organisms, as well as the delegated power to prescribe the information that must be published on such a register. I want to assure noble Lords that a list of matters which could be included on the register is set out in the Bill. This list includes, but is not limited to, information relating to the release and marketing notices, reports from advisory committees and enforcement notices. In the interest of transparency and public reassurance, this clause enables information concerning a wide range of matters relating to precision-bred organisms to be made public. We consider that specific details of the information to be entered on to the register are an administrative matter, though we will reflect on the comments made in the DPRRC report on this clause and respond to the committee’s concerns in our full response in due course. This clause is similar to the power in Section 122 of the Environmental Protection Act 1990, which enables the Secretary of State to prescribe by regulations the information to be entered on to the GM register. Therefore, the level of scrutiny we have provided for in relation to the information to be entered on to the public register regarding precision-bred organisms would be comparable to the equivalent provision for GMOs. I hope this provides noble Lords with the assurance they need ahead of our written response to the DPRRC report.
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- Lord Rooker (Lab)Labour
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- I beg leave to withdraw the amendment.
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- Baroness Bakewell of Hardington Mandeville (LD)Liberal Democrat
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- My Lords, I have four amendments in this group, and I have added my name to the amendment in the name of the noble Baroness, Lady Bennett of Manor Castle. When I first read the Bill, I made a note of the number of affirmative and negative procedures listed; there were 15 affirmative and 13 negative. The first time the Agriculture Bill came forward, it was berated because of the number of negative procedures and Henry VIII powers it contained. As we all know, the original Bill was paused and then amended, before being resubmitted for debate. The second iteration had far fewer negative procedures and received a far warmer welcome as a result. I have chosen carefully those negative instruments that I believe ought to be affirmative. The first is Amendment 26 to Clause 4, which is headed “Release of precision bred organism: notification requirements”. Although it is of course important that the Secretary of State decides on this, it is also vital that Parliament debates and understands the implications of what this considerable step forward—the release of gene-edited plants and crops—will be. This will be especially important if and when the science has progressed to such an extent that animals are included because, as the Bill stands, there is no mechanism for Parliament to be involved when this step does occur. As the noble Lords, Lord Winston and Lord Krebs, have demonstrated this afternoon, this is a fiendishly technical Bill that deserves close scrutiny. Next is Amendment 33 to Clause 11, which would give the Secretary of State the ability to include animals in the authorisation process. On Monday, we debated the efficacy of including animals in the Bill. Although there were arguments on both sides for this to happen, it was clear from the Minister’s response that the Government are determined for this to happen. It is therefore vital that, when this happens and the Secretary of State is ready to sign his or her authorisation, Parliament should have the ability to debate this addition in the Chamber or, more likely, in Grand Committee. Then there is Amendment 46 to Clause 18, on the precision breeding register. The noble Lord, Lord Rooker, has already detailed his objections to subsection (1) being included in the Bill. The clause gives extraordinary power to the Secretary of State. Although the Secretary of State must make the register accessible electronically, the public will have no say over how any of the subsections in the clause are implemented. As has already been stated, both on Monday and this afternoon, we are keen not to have a repeat of the previous GM abortive attempts to get legislation passed. This previous failure could be driving the Bill’s use of negative procedures for key elements. This is a mistake. You do not take the public or Parliament with you if you shut them out from the discussion and debate around decision-making. Moving to the affirmative procedure would ensure that Parliament had a say on the vital issue of the precision breeding register. My last amendment in this group is Amendment 52 to Clause 22, on the advisory bodies. Again, the objection to this clause being implemented under the negative procedure by the Secretary of State is one of public confidence. The welfare advisory body will be the gatekeepers to whom the public will look for reassurance that all is well with the progress of precision-engineered crops and, later, animals. To have this body appointed by the Secretary of State and paid for by the taxpayer without any parliamentary scrutiny is definitely not going to foster confidence in Parliament, certainly not among the public. Other noble Lords have referred to ACRE and the level of expertise of the people sitting on the welfare advisory body’s board. The interests of those appointed should be made available to the public and interested NGOs. Independence is vital. I have added my name to the notice by the noble Baroness, Lady Bennett of Manor Castle, about whether Clause 42 should stand part of the Bill. Again, this clause gives unlimited power to the Secretary of State to modify the Act in any way that he or she chooses without any scrutiny by Parliament. I support her on this amendment. I feel passionately about the role of the negative procedure. It does have its place, but not in the amendments I have listed. I trust that the Minister will have encouraging words. I beg to move.
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Lord Harlech (Con)Conservative- Quote
- My Lords, I beg to move that the debate on this amendment be adjourned, to resume the House to take questions on an Oral Statement.
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