20: Clause 3, page 3, line 35, at end insert—
“and unless the organism appears to be phenotypically healthy and has no defect likely to cause suffering.”
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.
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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I think the noble Lord suggested a third criterion: that the whole genome of any organism should be sequenced before it is then released into the environment as a precision-bred organism. That, to me, also carries a difficulty because there could have been spontaneous mutations during the process of precision breeding which have nothing to do with precision breeding per se; it is just the way the nucleic acid changes. Therefore, one has to ask with whole genome sequencing: what would you actually be looking for? What would be your reference genome? I am just wondering whether my proposition, of no visible effect on the phenotype, would be a suitable halfway house.
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.
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,
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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We are trying to set out some of the processes and frameworks that we think the Government should be setting out in the Bill. My Amendment 34 would require the welfare advisory body to undertake its own assessment of the potential impact of a precision-bred trait on the health and welfare of an animal and its qualifying progeny. Part of the problem here is that without knowing much about what the body will be and what resources are going to be available to it, there is a concern that all it is doing is taking a proposal written by the applicant and making a judgment on the basis of what it has just been told. So perhaps we should be checking some of the evidence that has been presented to it, rather than just taking it in good faith. Our concern is that some people, understandably, will want to get their application through, so it is going to be presented in the best possible light; we believe that the new body should be able to interrogate that thoroughly and properly. We have to ask whether we can be entirely sure that any evidence presented to the committee can be taken at face value. If we did want to interrogate it more thoroughly, how do we do that? The Bill does not answer that question, so it is important that we draw attention to that.
My Amendment 37 requires the advisory body to assess the welfare impact on animals where a precision-bred trait is developed with the aim of achieving fast growth, high yields or other increases in productivity. We have heard in previous debates in this Committee about traditional selective breeding producing animals that are highly efficient and effective in terms of food production, but there have been concerns about the welfare characteristics of some animals resulting from this. So the question is, if we can take this further, how far do we go? We think it reasonable that the body be able to assess welfare impacts as well, and it is not clear in the Bill how this would be part of the process. I am sure the Minister will reassure your Lordships that safeguards are in place that will allow that to happen, but we think it would be better if that was clear in the Bill itself. Amendments 36 and 38 add to that by requiring the welfare advisory body to consider welfare impacts on breeding stock.
Through these amendments we are trying to draw attention to any potentially unforeseen and possibly unintended consequences, which we think need to be addressed properly through the way the body is set up. The welfare advisory body should be able to consider direct and indirect, and intended and unintended impacts in all circumstances. Compassion in World Farming produced a very good briefing on this issue which I am sure noble Lords have seen; we should take its concerns very seriously. It highlighted that the Bill considers the impacts on the health and welfare of only the precision-bred animal and its progeny, arguing that the experience of selective breeding shows that altering an animal’s traits might have an unexpected impact on the health and welfare of the breeding stocks that produce future generations. In its view, we should be looking at how we safeguard those too.
In addition, many of the effects of selective breeding have been unintended. We have heard about this previously so I will not go into any detail, but what we are saying, as has been borne out by the Nuffield Council on Bioethics, is that the system we have created through traditional selective breeding poses a range of problems and challenges. This technology could exacerbate those issues and therefore needs to be looked at extremely carefully.
Clause 13 deals with precision-bred animal marketing authorisation. We believe the Bill could be amended to tidy that up, so we have tabled Amendment 39, which specifies that a Secretary of State can issue precision-bred marketing authorisation only if they are satisfied that there will be no adverse health or welfare impacts on the animal.
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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.
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.
“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.