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.
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.
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.
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.
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.
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.
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.
Finally, I hope the Minister has listened very carefully to my noble friend Lord Winston, and that he and his officials will take the time to look at the concerns he has raised.
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.
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.
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.
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.
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.
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.
We have made it clear that the measures relating to the animal welfare elements of the Bill are simply not well developed. As we heard in the previous debate on Monday, a number of us felt that on that basis they should be taken out of the Bill altogether until more detail was available. But, moving on from that finite position, we are now trying to make more constructive proposals about alternative ways of addressing this.
Amendment 50, which is in the name of the noble Baroness, Lady Parminter, focuses on the composition of the welfare advisory body itself. As the Bill stands, given that there is very little information, the functions of the welfare advisory committee could go to any number of existing welfare bodies, or indeed to one set up for this purpose. There is a proposal that the functions could be absorbed by the Animal Sentience Committee. In the Commons debate in July, the Minister reported:
“Applications to the committee have now closed … We very much hope to have the committee up and running by the end of this year.”—[Official Report, Commons, 7/7/22; cols. 261-62.]
So I am genuinely interested to know from the Minister whether he could update us on this. Is this committee in existence now, and is it being prepared to take on these duties? Six months have passed, so presumably the Government’s thinking has become more advanced on that.
So far, we have had very little reassurance about the expertise or competence of those that the Secretary of State is thinking of appointing to this role. But if they are there, and are people that we trust, we may take a different view. The amendment of the noble Baroness, Lady Parminter, makes it clear that we expect members of the committee to have a broad range of backgrounds and knowledge, which would enable them to come to a full and rounded view of the welfare implications of their decision. It also, as she said, provides for a lay member. I do think that that is important, because a lot of this discussion, as we have said before, is about public reassurance, and having a lay member there will provide some of that reassurance. It will also reassure the public that any decisions are not based on a narrow set of interests.
I only say this in relation to the other committee that we have referenced several times now—the ACRE committee. That committee is, I fully acknowledge, made up of people with a particular scientific expertise in their field, but six out of the seven scientists on the board of ACRE have links to commercial companies as well, and three of them quote Syngenta as an interest. My point is that we do not want to replicate this, or have a different body where there are those potential conflicts of interest that could cause members of the public to perhaps not have as much confidence in the committee’s decision-making as they should. I am sure that those people mean well and that they have scientific knowledge, but they also have to operate on an independent basis.
I think that my noble friend Lady Hayman has made the case very well for Amendment 87. It just makes it clear that the commencement date should not be enacted until we do understand more about the welfare advisory committee. As she says, it needs to have a remit which goes beyond the specifics and is able to deal with the direct and indirect impacts, and also unforeseen consequences —so, again, her arguments and the amendment are well made.
Finally, I will pick up on the masterclass from my noble friend Lord Winston. I would not even begin to try and argue with him; I sit in awe of everything that he is saying. I do hope that the Minister will meet him and talk some of these things through, because I do think that he has genuine expertise that he can share which will improve the substance of the Bill. I hope that the Minister will work with him on that basis.
I will pick up on the discussion about whether the research was taking place in a farmyard or a broom cupboard. I did note that Amendment 72A, the latest amendment from my noble friend Lord Winston, puts a specific requirement on participants in the research to have the appropriate scientific qualifications before they go anywhere near a petri dish. It would be reassuring to know that those people will have that expertise. I thought that was a helpful amendment as well.
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.
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.
I turn to Amendments 34, 35, 36, 38, 50 and 87, particularly on the points raised by the noble Baroness, Lady Parminter. These amendments are in relation to the welfare advisory body. I appreciate the concerns and reassure noble Lords that the powers in these clauses already allow the welfare advisory body to carry out proper assessment and report the results to the Secretary of State. Clause 12 sets out that the advisory body’s report must consider whether the notifier has taken reasonable steps to identify the animal’s precision-bred traits, and the risks to the health or welfare of the animal or its qualifying progeny that could reasonably be expected to result from those traits. The Bill enables the advisory body to request further information from the notifier.
Moreover, if the welfare advisory body considers that the notifier has not made an appropriate assessment, this would be reflected in its report to the Secretary of State, who can reject the application. We consider that this provides the right balance, ensuring that the Secretary of State has the necessary information to assess a marketing application without long delays and unnecessary duplication.
I will now speak to the form and function of the welfare advisory body. Clause 22 will ensure that we can designate the most suitable body to this vital role. As noble Lords will know, we intend to bring the provisions of the Bill concerning precision-bred animals into force once the regulatory system to safeguard animal welfare is established. The power in Clause 22(3) provides the flexibility to use whatever committee or other public body is most suited to the role when the time comes, or to create a new one if needed. I repeat: a new one may be created if needed. This gives future Governments the ability to reflect this area of fast-moving technological change.
Clause 22(4) establishes that the welfare advisory body will be a public body and therefore subject to the rules, principles and scrutiny which apply to public bodies generally. That addresses some of the comments of the noble Baroness, Lady Jones; I will come on to some of her other concerns in a minute. The members of the welfare advisory body will have sufficient scientific experience on the health and welfare of animals to be able to assess whether the notifier has correctly identified the precision-bred traits and the health and welfare risks.
The amendment suggests placing an additional function on the welfare advisory body in the Bill. I think that goes substantially beyond its core role of providing independent scientific advice on individual animal welfare declarations, and would require it to take on a role in policy and regulation which properly belongs to the Secretary of State. The amendment would, in effect, give the welfare advisory body the power to require the Secretary of State to set aside regulations that the Secretary of State had already made and had been scrutinised by Parliament.
The Bill’s powers will enable the Secretary of State to appoint an existing committee to this new role or, as I say, to create a new one if needed. Defra already has access to independent expertise on animal welfare, principally through the Animal Welfare Committee. We have been engaging with that committee and other expert bodies as the Bill has developed. The Animal Welfare Committee is also represented on the Scotland’s Rural College project steering group.
The noble Baroness, Lady Jones, asked about the sentience committee. As the Government explained when we took what is now the Animal Welfare (Sentience) Act through—it received Royal Assent in April—it required us to get actively working to establish the animal sentience committee. I am pleased to say that the chair, Michael Seals, has already been appointed. He is well known to Defra and has proved himself to be a very good adviser. We expect it to be some years before precision-bred animals are brought to market, so de facto the animal sentience committee will be established for more than 12 months prior to the first precision-bred animals coming on to the market, which addresses points in other parts of our debates today.
I turn now to Amendments 37, 39, 40, 54 and 55, which noble Lords have tabled in relation to the technical details on which the animal welfare declaration should be based. The Bill is intended to work alongside the existing animal welfare legislation to enable responsible innovation and protect animal welfare. Let me reassure noble Lords that the Government share the public’s high regard for animal welfare. We have set out our ambitious reform agenda in the action plan for animal welfare. As part of our plans for future farming, we launched the animal health and welfare pathway this year and will push forward to support continued improvement in farm animal health and welfare.
I will address the points made by the noble Baroness, Lady Hayman. While this Bill is not the place to address the conditions in which animals are kept, I remind noble Lords that animals in England are already protected by the Animal Welfare Act 2006, as well as by more specific requirements for farmed animals in the Welfare of Farmed Animals (England) Regulations 2007. Alongside these regulations, there are also statutory welfare codes for the main kept species. I raise this, more perhaps in response to some points made by the noble Baroness, Lady Bennett, and others when we were talking about this on Monday, to address the fear that this might be some sort of Trojan horse to allow overstocking or densities of animals. Issues such as stocking densities of farmed livestock are, as I say, regulated in legislation and in regulation. These include detailed requirements for the use of enriched cages for laying hens, farrowing crates for pigs, and pens for calves. The Bill is very much intended to go alongside existing animal health and welfare legislation. Keepers of precision-bred animals will be subject to the same legislative requirements concerning protecting and promoting good welfare as those of traditionally bred animals.
Moving forward with this legislation, we recognise that it is important to balance innovation with ensuring the introduction of appropriate safeguards to protect the welfare of precision-bred animals and their qualifying progeny. To set out the parameters in more detail in the Bill would limit the scope of this development and could prevent the implementation of the most appropriate, detailed measures, as developed through collaborative work with technical experts. Further, the power in Clause 25 allows us to set out in regulations what constitutes an adverse effect on health or welfare, including any parameters needed for assessing this. This could include consideration of any known health and welfare issues in selectively bred animals.
As mentioned before, the research we have commissioned from Scotland’s Rural College will help us to develop the criteria for assessment and evidence that must support the notifier’s application, which the welfare advisory body will then assess and report on to the Secretary of State. These details will be set out in secondary legislation and guidance. I confirm that the welfare declaration process will require notifiers to submit health and welfare information in response to prescribed questions and metrics. I believe that our framework is already capable of adequately addressing concerns about any health and welfare risks to a precision-bred animal and its qualifying progeny from any precision-bred traits. Adding a requirement to provide a wider evaluation of the quality of life for future generations of a relevant animal will lead to considerable uncertainty as to the overall basis on which a notifier’s animal welfare declaration will be assessed. I hope that this addresses the point that the noble Lord, Lord Cameron, raised.
Clause 14 will provide for the ability to make regulations requiring the notifier or any other person to monitor for significant adverse health and welfare outcomes in precision-bred animals which are authorised for marketing under the Bill, and their qualifying progeny, and report such outcomes to the Secretary of State. This addresses the ongoing requirement which the noble Lord rightly raised for the monitoring of these animals in future. This requirement is intended to pick up on the health and welfare problems that might arise after a marketing authorisation has been granted and the animals are being commercially produced. It is linked to the powers under Clause 15, enabling the Secretary of State to make regulations covering the suspension or revocation of a precision-bred animal’s marketing authorisation, in cases where new information shows that the health or welfare of the animal or its qualifying progeny is adversely affected by precision-bred traits.
The marketing authorisation will consider the whole life of the animal, and its qualifying progeny, in assessing whether any health and welfare risks arise from any precision-bred traits. I reassure noble Lords that I am confident that the most effective and proportionate means of keeping the requirements relating to animal welfare up to date is to set them out in regulations to be approved by Parliament rather than requiring amendments to primary legislation.
I turn to Amendments 24, 44 and 45, which seek to ensure that the Bill provides sufficient transparency. Clause 18(1)(j) already allows for these regulations to prescribe additional matters relating to this legislation to be published on the register of precision-bred organisms. I hope that that addresses the point that the noble Baroness, Lady Parminter, and the noble Lord, Lord Rooker, raised. I can therefore assure noble Lords that including the specific details set out in this amendment is not necessary, and I hope that this gives them enough information for the amendment not to be pressed.
On Amendment 24, I recognise that the noble Baroness is seeking to ensure that the Bill provides sufficient reporting requirements on the health and welfare of precision-bred animals and their progeny. During the stage before marketing, we expect that researchers or breeders will be collecting data for the animal welfare assessment that must be passed before precision-bred animals can be marketed. We also expect that any research involving precision breeding in animals in England will be covered by the ASPA regime, which is already effective and robust. Therefore, we do not consider it necessary to apply additional requirements. However, I reassure the noble Baroness that the type of information suggested will need to be collected before the animal can be marketed.
Before an authorisation can be granted to market a precision-bred relevant animal, Clause 11 requires a declaration that the notifier does not expect the health or welfare of the relevant animal or its qualifying progeny to be adversely affected by any precision-bred trait. Clause 11 also sets out that the application will have to be accompanied by an assessment of risks to the health and welfare of the relevant animal and its qualifying progeny that could reasonably be expected to result from a precision-bred trait, and an explanation of the steps required to identify these risks. We are trying to create a more proportionate regulatory system to enable research to take place, and much of the information will be collected as part of the marketing authorisation process.
With regard to Amendment 45, I reassure the noble Baroness that, in the interest of transparency and public reassurance, the Government are committed to maintaining a comprehensive, accurate and up-to-date register, because this information concerns a wide range of matters that she and the noble Baroness, Lady Bennett, rightly say that the public are very interested in. The register will be accessible by electronic means in real time on GOV.UK. Any interested parties are able to access the GMO register and can view all the applications for, and consents to release, GMOs, as well as notifications concerning release of qualifying higher plants. The precision-breeding register will follow the same regime.
I hope that my words have provided the assurance required for these amendments not to be pressed.
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?
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.
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?
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.
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.
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.
Amendment 20 withdrawn.
Amendments 21 to 23 not moved.
Clause 3 agreed.
Clause 4: Release of precision bred organism: notification requirements
Amendment 24 not moved.