Relevant documents: 19th Report from the Delegated Powers Committee and 8th Report from the Constitution Committee
Clause 1: Precision bred organism
1: Clause 1, page 1, line 4, leave out “or a precision bred animal”
Member's explanatory statement
This amendment is intended to remove animals from the scope of the Bill.
My Lords, in moving Amendment 1, I will speak also to Amendment 2 in my name and briefly comment on the other amendments in this group.
Many Peers will no doubt have received overnight the joint briefing on the Bill from Friends of the Earth England, Wales and Northern Ireland; the Landworkers’ Alliance; the Consortium for Labelling for the Environment, Animal Welfare, and Regenerative Farming —known as CLEAR; the Soil Association; GM Freeze; Organic Farmers and Growers; and the Organic Research Centre. The tone of that briefing reflects what I hear from academics and campaigners: they feel let down by your Lordships’ House. In Committee, we had a detailed, informed and productive debate on the contents of this Bill and the science behind it, and I single out the noble Lord, Lord Winston, for his rich and expert contributions and many amendments. Then they saw the list of amendments for Report, before I had tabled the amendments in my name, and it seemed as though all that debate and all the issues raised in Committee—not satisfactorily answered by the Government—had dissolved into a puff of smoke, or perhaps a puff of gene-edited pollen.
Many Members of your Lordships’ House attended a very informative online briefing on Friday and heard from an academic expert, Dr Michael Antoniou from King’s College London, about his concerns, and I think most noble Lords were copied into the subsequent detailed written exchanges that continued that debate. With that in mind, since Hansard does not yet allow footnotes in speeches, I put on the record two articles that I urge every noble Lord and civil servant who will be involved in this Bill and subsequent regulations to read and ponder: in Nature, on 12 January 2022, “Mutation bias reflects natural selection in Arabidopsis thaliana”; and, in Elementa: Science of the Anthropocene in March 2021, “Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies”.
In short, the first is a substantial debunking of the claim that the mutations occurring in nature are random. This is a subject of continuing scientific debate and a claim relied on heavily by the supporters of the Bill, but it is increasingly evidently incorrect. The second makes the point that even if you were to concede that similar detrimental changes take place through natural means, they are not transmitted around the world at the scale of our globalised industrial agricultural systems, which can spread mistakes before they are recognised. Your Lordships will note the date of those articles. The understanding of genetics and particularly epigenetics is changing fast and the Bill is stuck in the understandings of the 20th century.
All the amendments I have tabled, with one exception, offer a final chance: different routes by which your Lordships’ House could take a pause and allow reflection for the science and the understanding to catch up. I think it is telling that in the last few weeks I have had three major groups of scientists from different fields reach out to me to ask for advice on how they can get through to the Government—in the words of one, “to get the Government to understand our issues”.
There is further evidence for that and I will comment further in the next group on government Amendments 3, 5, 6, 9 and 10. These are amendments to foundational elements of the Bill. This is not mere tidying up—crossing the “t”s and the odd dotting of the “i”s. It is reminiscent of the mess we encountered in Committee on the Procurement Bill and the now gutted and apparently defunct Schools Bill. But here we are at the final stage, the last detailed consideration of the Bill, and the Government are still trying to play around with what it is actually all about.
As I said, my amendments—apart from Amendment 12, which is somewhat different—focus on giving us the chance to go slower, to pause, to look at this somewhat differently. In Committee and in the other place, there was much debate about whether animals should be included in the Bill—to draw a parallel, something that, as far as I am aware, is not even being considered in the yet to be settled debate on gene editing in the European Union. It is an issue of great interest to farmers, growers and food manufacturers in the UK—those who are still managing to export there even after Brexit. Noble Lords will see from the briefings that organic growers and farmers in the UK are very concerned about the Bill.
Amendment 27 in the names of the noble Baronesses, Lady Hayman and Lady Parminter, and the noble Lord, Lord Winston—and its associated amendments that make up the rest of this group—sets out a very fast timetable of 2026 for farm animals and 2028 for other animals. The best I can say about it is that it is better than nothing. Should it be put to a vote I will support it, but that is still a very short timetable in view of the time it takes for science to get from the lab bench to the peer-reviewed publication, let alone the time it takes to then reach government understanding.
Amendment 1 excludes animals and Amendment 2 in my name would exclude animals and plants not used for food production. We are told again and again by the Government that they want this Bill for food security—they want to be able to produce food—even though it looks a lot like a Bill designed for and by the multinational-dominated biotech sector. But if it is for food, why allow companion animals—or, indeed, as the noble Lord, Lord Winston, said in Committee, and the Minister admitted, the gene editing of great apes, the species whose closeness to us has been highlighted only this week by research showing we have an embedded understanding of their gestural language?
So, what I have done with my Amendments 1 and 2 is offer the House a final chance to deliver the changes to the Bill that many were expecting. It is not my intention at this point to call a vote on either, unless the House should signal that it does want to reflect, pause and at least proceed more slowly on a major change in our relationship with the natural world—in the natural world—as human animals in an immensely complex system that has developed over hundreds of millions of years.
I have a final thought on the damage we have done in the past century or so. Instead of relying on and working with natural systems—what we now call agroecology—when crop yields have fallen, we have thrown NPK fertiliser at the fields, produced often at massive carbon cost and with huge environmental impacts. When a field has pests or diseases, we have thrown a pesticide at it, a poison. “It’s safe”, they say—until it is shown that that pesticide is not; the most recent, of course, being neonicotinoid pesticides, whose use the Government have again just approved, despite weekly new reports of their dangers. That reductionist, silver-bullet approach to managing our world has got us where we are today, with the world’s soils in a parlous state, the planet’s capacity of geochemical flows exceeded, biodiversity in a state of collapse and public health exceedingly poor even, or especially, in the wealthiest nations.
HL Mencken said something along the lines of, “Every complex problem has a solution which is simple, direct, plausible and wrong”. We really have to stop reaching for the wrong solutions, which is what this Bill does. My Amendments 1 and 2 at least slow down that outreach. I beg to move Amendment 1.
My Lords, I shall introduce my amendments in this group, Amendments 11, 27, 29 and 30. I thank the noble Baroness, Lady Parminter, and my noble friend Lord Winston for their support. I declare my interest as laid out in the register as president of the Rare Breeds Survival Trust.
During our Committee debate, the Minister stated that the Government’s intention was to take a step-by-step approach, particularly around the introduction of animals, and that the Bill had the ability to do so. Our concern is that we have heard no clarification as to how this will actually work. By what means do the Government intend to introduce provisions related to distinct species, rather than the “relevant animals” as a class, under the Bill as currently drafted? Despite the Minister’s assurances, we still have no guarantee that this step-by-step approach will actually happen.
My Amendment 11 would set this expectation on the face of the Bill. Combined with my Amendments 27, 29 and 30, the effect would be to prevent a precision-bred animal being released until it had met the date condition provided by my new clause, which would follow Clause 47. This proposes that, for farm animals, the date is no earlier than 1 January 2026, and for other animals, no earlier than 1 January 2028. Also scientific evidence must support this extension: if it does not, the date could be put back further. I just say to the noble Baroness, Lady Bennett, that this is not an automatic introduction at that date; it is just putting the step-by-step approach on the face of the Bill.
The reason I have tabled these amendments is that, whether we agree that animals should be included or not, clear concerns were expressed during our Committee debates as to when they should be included, how quickly they should be included, and whether all animals should be included at the same time. We believe there is insufficient detail in the Bill regarding concrete provisions around timeframes: many of them are vague and noncommittal. Much of the preparation that we believe is necessary for a regulatory framework for animals has not yet been properly carried out.
When this issue was debated in Committee, the noble Lord the Minister said:
“All I can do is assure noble Lords that nothing will happen before we are in the right position to do it … The priority will be to try to do this for farmed animals first, and we want to make sure that we are operating a step-by-step approach. If we put it in the Bill, it may be too prescriptive, because we are in a fast-moving area of science, and it may constrain the ability of the scientific community to progress this if we do it in the wrong way.”—[Official Report, 12/12/22; col.503.]
We listened to the Minister’s words and, in order not to tie the Government’s hands or constrain the scientific community if there is clear evidence, for example, of a scientific breakthrough in tackling bird flu, the amendment allows for flexibility. An accelerated timetable should come in only if scientific opinion supported this. So we have not set these dates in stone in either direction.
I hope the Minister can see that we are taking a constructive approach to trying to put step-by-step on the face of the Bill. However, if he is not prepared to accept our amendments, I intend to seek the opinion of the House.
I thank the noble Baroness, Lady Parminter, for her courtesy in giving way. I will make only two brief comments. The first addresses the point that the noble Baroness, Lady Bennett of Manor Castle, raised, particularly the reference to the workshop that I helped to organise last Friday, where we had a number of experts giving us their take on the science. It is very often—in fact, usually—the case that scientists do not absolutely agree on everything; that is just the way that science is. When you go as a scientist to a conference, you do not expect everybody to say, “Fantastic, your research is absolutely superb”. People criticise it and challenge you and say, “Why are you doing that in this way and not some other way?” But there is sometimes a centre of gravity of opinion. Science goes through different phases. There may be no agreed position and gradually over time it is possible that a position consolidates in a particular way.
I think it is fair to say that Dr Michael Antoniou, to whom the noble Baroness, Lady Bennett, referred, is probably not in the centre of gravity of current opinion on the safety issues and other technical aspects of gene editing. So while I absolutely applaud the noble Baroness’s point which raised the diversity of opinions in the scientific community, I do not think your Lordships should be too swayed by a particular individual’s point of view, because I do not think it is the centre of gravity of scientific opinion.
My second, very brief point concerns timescales and is related to the amendment in the name of the noble Baroness, Lady Hayman of Ullock. One can see this in two ways, as her introduction to her amendments implied. You could see it as putting the brakes on—do not rush too quickly before you are sure—as the noble Baroness, Lady Bennett, would wish us to do. On the other hand, towards the end of her speech, the noble Baroness, Lady Hayman, said, “We don’t want to hold things back”. On the one hand we do not want to rush, and on the other hand we do not want to have the brakes applied too sharply.
I am trying to anchor that in a bit of reality. As far as I am aware—I was told this at the meeting last Friday by Professor Bruce Whitelaw, director of the Roslin Institute in Edinburgh, which is the UK’s leading centre for this sort of technology in animals—in the US, the Food and Drug Administration is already reviewing a licence application for gene-edited pigs. The animal genetics company, Genus, in collaboration with the University of Missouri, has developed a pig that is totally resistant to the virus that causes porcine reproductive and respiratory syndrome—PRRS for short. So the question in assessing the amendment proposed by the noble Baroness, Lady Hayman of Ullock, is, would that amendment hold up the commercialisation of this pig, if the FDA and the relevant bodies in the UK approved it?
Given that it would improve pig welfare, because PRRS is not a pleasant disease, and save the pig industry a very large amount of money—an estimated $2.5 billion a year in Europe and the US alone—do we want accidentally to place a barrier on that kind of development through timescale limits? I do not land on one side or the other; I just think it is useful to have a real-life example of what is going on. My question to the noble Baroness, Lady Hayman of Ullock, is this: if this PRRS-resistant pig came to market before 2026, would that count as an example of where the 2026 hurdle should be removed, because it is ready to go, or would she want to keep it in place? The question on the other side is whether it will realistically go from FDA approval to commercialisation in about three years. I am not trying to land on one side or the other, just to anchor this in a specific example which may help us think through our response to the proposed amendments.
Just to come back on that, proposed new subsection (4) in my amendment says:
“The Secretary of State may, by regulations, amend the dates listed in subsection (2)”—
the dates I read out—
“if the requirement under subsection (3)”,
which is the evidence condition the noble Lord is talking about,
“is met before the dates”.
There is flexibility in the amendment to bring those dates forward if that scientific evidence is there.
My Lords, I will intervene briefly on a point of information. I do not think the noble Lord, Lord Krebs, has helped his cause, although he is very knowledgeable in this area and I pay tribute to him in that regard, in mentioning that a particular academic is not deemed to be at the centre of gravity on these issues. Who are we to judge? This is a fast-moving and complicated field. We are leaving what has been a highly regulated area, where our farm products have moved very freely between here and the European Union; if we go down this path of very light regulation in the Bill, how do we know that the EU will accept our food products? I shall listen very carefully to my noble friend’s response, in particular to the amendments from the Opposition Front Bench.
I feel that there is an uneasiness and lack of understanding among the public about this, which I share. I am in awe of the Roslin Institute in Edinburgh; it is my alma mater, although I studied law rather than science or veterinary science. I realise that cloning is different, but the very fact that we do not seem to be going down that path, which was first brought up with Dolly the sheep, raises issues. I am very uneasy about moving to light-touch regulation when the science is not at one on this issue.
If I could just interrupt the noble Baroness, I think it is wrong to bring up Dolly the sheep in this conversation, because this has nothing to do with cloning. It is a completely different technology.
While I am on my feet, I will respond to her point about how we know where the centre of gravity of scientific opinion is, who is to judge it and whether it will change. I appreciate her kind words about me; I am a scientist but I am no expert in genetics or gene editing. However, I know from my general experience of a lifetime as a scientific researcher that, when there is a centre of gravity of opinion, there are always outliers. Sometimes those outliers turn out to be right and there are transformations, but I have seen no evidence at this stage that the outliers are right and the centre of gravity is about to shift. That is all I want to say.
My Lords, I remind my noble friend Lord Krebs—and I call him my friend because I have huge respect for him as a scientist, a Peer and a contributor to the House—that one of the great outliers was Dr Oppenheimer at the time of the Manhattan Project, who afterwards recognised what had been released as a result of that. We know very well that every single piece of technology that humans have ever produced has a downside we do not expect, and do not recognise and predict at the time. I would argue that this is one of those examples of a technology, which we have a duty, as a House in Parliament, to examine extremely carefully. I am not sure we have done that yet, and I am not sure how we can do it very well.
One of the problems with the Bill was that I was told that a number of my amendments were not within its scope because it was about the release of the organisms but not the science, and so many of those arguments went before they were even tabled. That is a real problem. In my view, we are embarking on a massive experiment which could have global repercussions—I put it at that serious level. When we start to introduce animals with a particular lack of diversity, or even with diversity, or different species in different areas, we have no proper data to analyse to make certain that we are not doing things that may be harmful to the planet, the environment or human health, or harmful to microorganisms and viruses, or perhaps even promote viruses.
It seems to me the Bill has been produced for one main reason: the notion that we would take back control from the European Union—this was originally part of the legislation which was prevented for us going forward. It seems to me that the Bill has been fairly rapidly produced to take back control. But in taking back control, we may actually lose control, because we might affect the environment in ways that are not certain, and I put that to you with all modesty. I do not know the answer to it.
I pay my respects to the Minister; he has listened very carefully, and clearly recognises his duty to working out how we deal with this Bill. One of the questions that comes up is the very thing that the noble Lord, Lord Krebs, has mentioned, which is the notion of the centre of the argument. I do not accept at all that the Roslin Institute, or the evidence we heard last Friday from the John Innes Centre, represent scientific opinion. I think it was extremely narrow and, unlike the noble Lord, Lord Krebs, I was deeply unconvinced by the arguments I heard.
I must pay tribute to Michael Antoniou, who has just been mentioned; he is a senior gene therapist at King’s College Hospital, and is extremely worried by the Bill. He knows more about modifying genes than many of the people who have been talking about it. He was also at that meeting and, like me, was very concerned about what he heard. A series of letters were written to various people, including to Bruce Whitelaw, and we have not had satisfactory answers to the questions we raised. This is something that we need to understand, because this is an extremely complex process.
One issue raised in the arguments is that the genes of plants and animals—plants in particular—are so complex that we cannot understand them, that they mutate all the time, and that all sorts of doubt occurs with plants; we hear this again and again. If there is so much uncertainty, this is a very good reason to do more research before we promote the experiment into real life. Unlike some of my colleagues, I argue that, although my noble friend Baroness Hayman is going to introduce an amendment which will try to delay the implementation with animals, in many ways the modification of plants is more dangerous. If something is so complex, we need to understand that complexity a bit better than we do at the moment. Plants propagate in a way that animals do not; you cannot corral plants as you can most animals. That represents a very serious issue: they propagate through birds, insects and the wind, and in all sorts of ways that we do not have sufficient means of controlling. I am very concerned about that.
Let us come down to the complexity of this matter. It is very clear from what we heard about genes from our so-called experts—I do not mean to be in any way rude to them because these are matters of opinion—is that it is not true that there are genes for the expression of a particular aspect of the genome. Genes vary depending on what happens around them. They are influenced by other genes. So if one carries out a modification just by editing a genome, that does not necessarily prevent all sorts of other genes changing the way in which they express afterwards. That is one of the big problems in nature.
Epigenetics was mentioned by, I think, my noble friend Lady Hayman. We are understanding more and more about it. Let me explain what it is. Epigenetics is, essentially, the response of genes to environmental influence. Genes are not just there based in stone but depend on the changes in the environment as regards how they express. We now know that they can be inheritable and that we can sometimes change that inheritance. However, the full understanding of epigenetics —certainly in human biology, which has been studied far more than it has in most farm animals—is very far from being clear. It is no question that we have known that epigenetics has been an issue in plants since the 1700s, from the time of Linnaeus, who was the first person to understand how plants modify their shape, flowers and leaves in all sorts of ways in response to the environment. That process is, in fact, heritable. That interesting point suggests that we still have not grasped fully exactly what is happening with the genome or how it might be changed. We therefore must understand that gene function is extremely complicated.
The interaction of genes is also complicated, and when we start to meddle with things we do not necessarily find what we expect, and sometimes they are markedly different. Although gene therapy has been carried out since as early as about 1990, we are limited in how we can do it in humans because we do not know the outcome. Gene therapy uses techniques such as CRISPR, the current method. Changes to genes during development also change. One issue here is that this technology is far from precise. We must understand that it is imprecise.
During the discussions on the Bill, a couple of matters that we have not gone into have worried me and affect all the amendments today. One issue is ethics. We have talked a little about the ethics of our responsibility to animal health, but we have not considered ethics on a wider basis regarding the protection of human life—making sure that we protect the environment to be certain that we do things that are not damaging, and at the present time we do not know.
We are faced with one of the greatest problems that have arisen as a result of technology, and that is climate change. That started with the Industrial Revolution, but we are only now beginning to understand it. We still debate how far humans have been involved in that problem. That is one of the downsides we must face.
One of the issues as regards ethics is if we start to change diversity. I should mention that last Wednesday, when the noble Lord, Lord Benyon, at the Dispatch Box rightly pointed out the importance of diversity, his answers to questions on avian flu and wild birds were admirable because he mentioned the need to be cautious. He said repeatedly how important it was for the Government to follow the science. That is the problem here because the science will vary, depending on who one is dealing with. I am just one person, but I have been trying to modify genes in animal models for at least 40 years, a long time. I have therefore seen how unpredictable these sorts of activities remain, even now.
I do not want to go on at great length, but one of the things that also concerns me with regard to the delay is how the criticism we made to the scientists—we said, “We need more data”; they said “Well, we can’t do the data, as it’s too complex to get the data”—is not true. Of course, nowadays, we do all sorts of computing and have other ways of getting massive data. This is an area where that data is essential. One of the amendments we tried to put down in Committee suggested that we look at the genomics, look at the whole function of other aspects of the genome and the phenotype—that is, the visible appearance of an organism —and have those things computed in. Of course, at the present time, we do not have the data. As far as I can see, in this Bill, there is no mandatory requirement for that data to be made available. The question of whether it should be secret is in a different amendment; we will probably come on to it. I would argue that we are standing on a cliff. The problem here is a key one.
I end with just one point. The Minister, the noble Lord, Lord Benyon, referred to that what we are trying to do is simply imitate nature—I am paraphrasing, of course, but noble Lords understand that I mean we are trying to use natural processes. However, we are not. We cannot do that because one of the differences is that there is evolution in nature. Evolution takes time. It takes decades, even hundreds or thousands of years. Homo sapiens has evolved over at least 100,000 years, probably a bit longer. The real issue here is that, during evolution, the genes have a chance to respond to their environment. Our human qualities now represent a response to our environment; that has changed, of course, so we have gradually changed with it. What we are doing here with gene editing is changing suddenly and sharply. That is not evolution; it is in fact a forced change in the genome. This is risky and certainly something that has not been looked at in terms of general populations of animals and plants in enough detail for us to be confident that we will not do damage.
I say to all of us in this House, because I really feel it, that I certainly support the amendments we have heard about so far. I do not think that they are ideal but they are perhaps the best we can achieve in the time available to us. We must understand that, when we vote, we have a grave responsibility to understand that we could do great harm. The question then is this: what is the good of what we are doing? We are not going to change the feeding of the world’s population with genetically modified crops; actually, that could have been done already had we had the sense to look at how to protect cereals, for example, so many of which are destroyed during storage for all sorts of reasons. One of our responsibilities is to look at how and why these measures are needed. Unfortunately, at the moment, there is a risk that this could be something that is of commercial value for a time but is not necessary for human, planetary, animal or plant value.
My Lords, I hope the Minister will see that these amendments in the name of the noble Baroness, Lady Hayman of Ullock, are helpful because they give expression to what he said in Committee: that the Government will move forward on a step-by-step basis.
Why do I think that is important? First, again in Committee, the Minister made it absolutely clear that there were no institutions or research bodies—nobody—making a claim that they wanted to do any form of gene editing on anything other than farm animals, and that the only reason why animals beyond farm animals were in the Bill was, to quote the Minister, to “future-proof the Bill”. That is fine, but let us give expression to that future-proofing by ensuring that there is a degree of phasing.
Secondly—this is the point that the noble Baroness, Lady McIntosh, touched on—the consultation that the Government did on the statutory instrument in advance of this Bill indicated that there was no support from either consumers or retailers for the sale of animal products into the market. The public appetite is therefore limited. Those of you in this Chamber who are strong proponents of gene editing could very well argue that this phasing amendment would allow time to bring the public along with us.
The third argument, as I think the noble Baroness, Lady Bennett, mentioned, is that while Europe is looking at gene editing, it is not looking at animals at all, and it is a major trading partner. The Welsh have opposed this legislation and, if my timing is correct, the Scottish are voting at this very moment to turn it down as well. Therefore, key partners of ours are moving at a slower pace than ours and therefore there is a strong argument for moving at a measured pace.
However, the strongest argument, which I think will find favour with the noble Lord, Lord Krebs, and others, is for doing this based on the evidence of the science. Yes, we need a proportionate regulatory framework, but we must ensure that we are learning the lessons at every stage and monitoring the adverse effects. We will come to an amendment about this later. Then, going forward, animal welfare is guaranteed, and public benefits are maintained. An argument that allows this in a phased way is the right regulatory approach. If the noble Baroness takes this to a vote, she will have the support of these Benches.
My Lords, I will make one or two points, particularly with respect to the comments made by the noble Lord, Lord Winston.
Regarding imprecision, conventional breeding is totally imprecise. Mankind has been breeding animals for thousands of years, just looking grossly at the phenotype, the way animals look and so on. Recent research on pigs has shown that if you breed two pigs —a boar and a sow—and do whole-genome on sequencing on all their progeny, there will be at least 100 mutations in the DNA of each of those progenies which are not represented in either parent. Every time we breed every animal now, on every farm, in every house, in every stable, we have a very imprecise system which is constantly throwing up genetic variation.
Applying this more precise breeding will be done under very controlled conditions in research establishments which will be thoroughly looking at the changes in the genomes of the animals long before they are released. Remember that when we market animals for breeding, we control the breeding. We have had assurances that mechanisms such as gene drive will not be included in this legislation. Every precision-bred animal that is genetically edited and put on the market will be bred by humans controlling that breeding.
Lastly, regarding ethics, there are counter-ethics, and the bus has already left the station on this. The noble Lord, Lord Krebs, mentioned the work on PRRS. There is some very encouraging work coming through which indicates that we may be able to create poultry with a degree of resistance to avian influenza. An Israeli research group has published information on being able to produce only female chicks from layer breeder flocks, thus preventing the unnecessary destruction of half the chicks born for laying purposes because they are male. When we have the potential to reduce the burden of disease in animals which are under our control, is it ethical not to take up that opportunity?
My Lords, I declare an interest as a dairy farmer and as an investor in a number of agriculture-related businesses around the world. I also declare negligible scientific credentials, unlike many noble Lords who have spoken.
However, I believe that it is essential that farmed animals are included in the Bill without undue delay, and I am very much against any amendment which delays or removes these animals. I have previously mentioned in this House that I could raise the output of my herd by 23% were all my cows blessed with the same genetics as my best cow. As noble Lords have already mentioned, there are disease benefits. Another example is the Roslin Institute’s engagement in gene editing of salmon, which improves resistance to infectious pancreatic necrosis viruses. These are meaningful benefits and I agree that they also improve animal welfare.
I would also add that I do not entirely recognise the world that was described by the noble Baroness, Lady Bennett, earlier. Agricultural productivity continues to increase globally, powered largely by ongoing plant and animal selective breeding. I believe that we have an obligation to unleash this technology of precision breeding to further increase production globally and support a growing global population.
Before the noble Lord sits down, I wonder if he might be kind enough to comment on this, seeing as he wanted to breed his best cow with all the other cows to reduce genetic diversity. Can he tell me what happens if a virus comes along to which that herd is susceptible? What do you do then? That is the problem.
I think my noble friend is quite right: we will depend on increasing productivity and will be able to do that only by breeding. The whole point of the Bill is selective breeding; actually, it is precision breeding. The noble Lord may well have this nightmare that we are releasing something ghastly into the world; I do not believe that is true at all. It is done because of objectives in the breeding programme, which is precise. This is just the sort of thing that I do—and I declare my interest as a horticulturalist, as the House well knows—when we are breeding bulbs and daffodils. But this is more serious; this is not about domestic gardening but is about feeding the world and making it possible for the diversity that exists in gene stock to be harnessed for greater productivity.
I do not want to argue with the noble Lord about this too much but, actually, I have to say that there is good evidence. For example, with gene editing and the operation called i-GONAD where you can change embryos, most of those animals look perfectly normal and would pass without their gene being changed, but it turns out, of course, that they do not actually fulfil the requirements that you eventually have for the gene. That is one of the problems. That is a serious issue because you change other genes; not as a result of editing them, but by having those other genes edited. That is a big problem.
My Lords, I will briefly respond to the noble Lord, Lord Winston, on that point. It is a fair question, which we do need to respond to: what happens if we narrow the gene pool and expose animals to genetic risk? There has been evidence in the past that by narrowing the gene pool in dairy cows, we have had lameness problems; there has been an issue in other species. That is because we have not properly understood; indeed, random breeding, as the noble Lord, Lord Trees, has said, has resulted in that kind of action. Through better understanding of the genes, and through ensuring that we retain as wide a gene pool as possible from which to choose, but being selective and more careful and intelligent about the use of those genes, we should avoid that consequence.
My Lords, I start by reminding noble Lords of my entry in the register. This has been a fascinating opener for this afternoon’s proceedings. I know that this is an area of great importance to this House. I want to take account of the concerns raised in the debate and more clearly show our intention on this issue. Perhaps I should start by saying that, having been in, then out and now back in Defra over about a decade or more—and not being a scientist—I absolutely do take the point made by the noble Lord, Lord Krebs. I try never to use the words that the noble Lord, Lord Winston, attributed to me, which was that I was following the science. The science is imprecise, and what we have to do as policy- makers is take a view, listen to reputable people who advise us and organisations both here and around the world, and hope we get it right.
I shall say just two things at this stage of the proceedings on what my involvement in the Bill is not about. First, to tackle what the noble Baroness, Lady Bennett of Manor Castle, said—that this is somehow to satisfy the demands of the global agricultural corporations—no, it is not that. As far as I know, we have had no lobbying from any of those organisations, and this is about something else which I shall come to. Secondly, it is not about taking back control. For me, it is about looking at crops that I see frying in heatwaves that we never had when I was younger. It is about talking to farmers who have Belgian Blue cattle that can give birth to calves only by Caesarean section because they have been bred through traditional breeding methods in a way that makes natural calving impossible. It is about correcting some of those aberrations that have existed, as well pointed out by the noble Lord, Lord Trees. We can tie ourselves down with negativity about this, but the opportunities for this legislation, what it offers for animal welfare and for tackling issues such as climate change, are immense.
On the amendment to remove animals from the Bill completely, as was highlighted in Committee and in today’s debate, I say that it is vital that animals remain part of the Bill. We focused on farmed animals in debate because there is already research in the UK and abroad showing the exciting potential of precision breeding to help tackle some of the most pressing challenges to our food system, the environment and animal welfare. These challenges are significant, and while these technologies are not a silver bullet, they can work alongside other approaches to help us to improve animal health and welfare, enhance the sustainability of farming, and strengthen food security and resilience. It is vital that we create an enabling regulatory environment to translate the research that we have already highlighted in debates into practical, tangible benefits.
It is equally vital that these technologies are used responsibly. That is why we have included specific measures in the Bill to safeguard animal welfare. These go beyond what is required for traditional breeding and under current GMO requirements. We therefore do not see this legislation as a route to lowering welfare standards. Instead, we see it as a real opportunity to improve animal welfare and our food system.
The debate about outliers was fascinating. As a policymaker, I quite like challenging Defra scientists and those who advise us by pushing an outlying piece of science, something that may not even be peer-reviewed. It is one of my criticisms of the scientific lobby that, to get peer-reviewed papers, you have to be in the centre. In this case, I have looked at the broad range of views in the scientific community. I entirely endorse the sentiments put forward by the noble Lord, Lord Krebs. However, I understand concerns raised in the debate about the use of precision-breeding technologies in certain groups of animals, such as companion animals, and I recognise and agree with noble Lords on the importance of building confidence in the regulatory system.
There is a case for prioritising where there is the greatest research interest and where there are greatest potential benefits for animal welfare in our food system. That is why I want to make a commitment on the Floor of this House that we will adopt a phased approach to commencing the measures in the Bill in relation to animals. In other words, we will commence the measures in the Bill for only a select group of animal species in the first instance before commencing them in relation to other species. For example, in the first phase it is likely to be animals typically used in agriculture or aquaculture.
As indicated during Committee, we intend to use the commencement powers within the Bill to achieve that. These powers allow us to bring the provisions in the Bill into force in relation to a specific list of species or group of animals; for example, we can apply the provisions to cattle by stating the species name as Bos taurus—domestic cows. That means that until the relevant commencement regulations applicable to them are made, some species or groups of animals, such as companion animals, will not be affected by changes in the Bill. Likewise, GMO rules would continue to apply to them if they are produced using precision-breeding technology. Taking this approach allows us to limit the practical effect of the Bill for a time, while retaining the flexibility and durability needed to capture the potential benefits in other species in the future.
I question the point raised by my noble friend Lady McIntosh that there seems to be great opposition to this. Of course, it depends on the question asked, but we know that public levels of understanding are low, and that public sentiment is more in favour particularly if the use is associated with a benefit. For example, FSA research last year found that 54% of people think it would be acceptable to use the precision breeding of plants in food production, while just 16% say that it would be unacceptable. A BEIS survey from 2019 found that 63% of participants supported the use of precision breeding for disease-resistant crops, 65% for crops resistant to adverse weather, and a similar number for an increase in health benefits in fruit and veg. I know that we are talking about animals, but it is worth pointing out that there is public acceptance of much of what we are talking about.
As I said, the priority for the first phase would be animal species that are typically used in agriculture and aquaculture. We would like to gather and consider further evidence and continue our engagement with key experts before we define the full list of species we intend to introduce first.
If it helps the noble Baroness, Lady Hayman, I think that this answers her point: if the Bill passes, plant commencement regulations would come forward in 2024, but I do not foresee, unless science moves at a particularly rapid rate, that plants would be ready for market for four to five years from Royal Assent. I suspect animals to be two to three years after that, so significantly beyond—if I got it right—the date that she mentioned. I do not want to restrict this or future Governments; I do not want to restrict the benefits that could accrue from this technology if suddenly, as the noble Lord, Lord Krebs, mentioned, a particular area of work could be brought forward that would be of huge benefit.
Before the measures in the Bill are introduced to other species, such as companion animals, we will gather and consider further evidence. We will include monitoring of research and commercial developments, and consideration of animal welfare assessments in such species. The research we are undertaking with Scotland’s Rural College is the first step but, again, this will involve engagement with key stakeholders and experts. I entirely endorse the point made by the noble Lord, Lord Trees, about PRRS—that has to be in our minds when we are talking about this.
I could listen to the noble Lord, Lord Winston, for ever; apart from his having the most mellifluous voice, he is a fantastic communicator—I have watched him on television—but I question his belief that Britain is somehow an outlier. We are aligning with many international partners—for example, the US, Canada, Japan, Argentina and Australia. The EU, as he knows, is also intending to introduce a more proportionate regulatory framework, and we follow that with interest. I hope that he sees that we are part of a wider group of countries that are gently moving forward in a way that accepts high levels of regulation, but also the benefits that this technology could accrue.
It is encouraging to think that the Minister would pick one genus of defined animal such as Bos taurus, but how long would it remain the only race being investigated? Moreover, they are only about half of the cattle beasts; there are also all the beasts descended from Bos indicus that occupy tropical areas.
I understand the point that my noble friend is making. I cited Bos taurus as perhaps the greatest priority in our minds, but I have also mentioned the benefits that would accrue if we could tackle conditions such as PRRS in pigs. He is right that there are other genuses across farm animal species that we must consider.
As I said, we also intend to produce guidance on the animal marketing authorisation process outlined in the Bill. That will include guidance on the evidence that regulations will require to be submitted alongside the animal welfare declaration by the breeder and, if necessary, more specific guidance relevant to particular species. Through that consideration of evidence and clear guidance, we will ensure that the regulatory system works effectively for different species of animals. I hope that the Government’s intended approach, our commitment to phase the introduction of animals under this legislation and the words that I have said from this Dispatch Box are clear and reassuring for noble Lords. I ask noble Lords to consider not pressing their amendments.
My Lords, I thank the Minister for his answer. I thank everyone who has participated in, as he said, this fascinating, detailed and high-quality debate.
I will start with the small bombshell that the Minister that just dropped. We appear to have had a new outline for the way in which the Bill is to be implemented presented to us at the final stage of Report on the Floor of the House—and, as the noble Duke, the Duke of Montrose, pointed out, with some very unclear elements where we suddenly appear to be covering half the cattle but not the other half. I question whether this is the way in which we should be making legislation.
I want to raise a point on something the Minister said which has not been raised before: why is aquaculture here? As the noble Lord, Lord Winston, said, the reality of land animals is that at least you can keep control of them and muster them fairly well. If we include aquaculture in the early stages, we have to realise that once you release something into the sea, as we know from farmed salmon, there will of course be escapes. We have not had a chance to debate all the things the Minister just said.
I want to go back to first principles. I return to the immensely powerful and important speech by the noble Lord, Lord Winston. As he said, he has 40 years’ experience of working with genes. He is your Lordships’ House’s absolute expert. The noble Lord said that we are embarking on a massive experiment with potential global repercussions, but we do not understand what we are doing. Before I go further, I want to put those words to the Minister. My understanding is that the precautionary principle is part of government policy. How does this Bill fit with that principle?
Let me address some of the points that the noble Baroness has made. The Government have always said that our priority for the rollout of this technology will be plants, then animals. I have added to that the reassurance, in frequent meetings that I have held with noble Lords before today, that we can phase that part of it as well. So I do not consider that to be a bombshell.
ACRE, the body that advises the Government on releases into the environment, has recommended that precision-bred organisms pose no greater risk than their traditionally-bred counterparts. Its advice is supported by the Royal Society, the Royal Society of Biology and the Roslin Institute. As for food and feed, consumer safety will be ensured through a case-by-case assessment by the FSA to ensure that products are safe for consumption.
So I hope the noble Baroness feels that his is not a bombshell, that clear processes are involved and that we have been, in every way, precautionary about how we do this. I put it to her that surely it is being precautionary to tackle some of the problems we face. The greatest challenge ever for humanity is to adapt to climate change and to produce food in a way that a modern society, a civilised society, wants—to make sure we address issues such as animal welfare. That is the opportunity of this Bill.
I thank the Minister for his answer. I will pick up that point about animal welfare, and indeed pick up the points made by the noble Lord, Lord Krebs, about pigs in the US that have been gene-engineered—or, rather, gene-disrupted— to make them resistant to porcine reproductive and respiratory syndrome.
This is a case of knocking out one gene in these pigs. We know that any given strain of a virus mutates at a rapid rate—we only need to look at Covid-19. Where we have pigs held in the kind of crowded, dangerous conditions in which we know pigs are held in the US, the virus will mutate very quickly. We have been through this many times. We had it with resistance to pesticides: we got rid of a single disease with one gene and then, of course, it goes. This is the way that biology works, as the noble Lord, Lord Winston, said. We hold those pigs in the kind of crowded, dangerous conditions where PRRS is a concern. Let us remember that this genetic change is only against that one disease. When swine flu arrives, there is nothing in those pigs that will protect them against it, or prevent it becoming a zoonosis and crossing the species barrier into humans. Yet we continue those farming practices.
I pick up the point from the Minister and the noble Lord, Lord Taylor of Holbeach, who said that this is the only way we will feed the world and the only way to get more production. That is what we were saying in the 20th century. The discussion on Friday that I referred is only a preprint, but it reflects the direction of the new biology. The noble Lord, Lord Krebs, said that there is a centre of gravity, but we also know there are tipping points. The new biology acknowledges that a wheat plant and every other complex organism is a holobiont; it operates as a complex of what we think of as the plant, bacteria and fungi that work together. The preprint showed that when a wheat crop is dealing with drought, the epigenetic changes—the kind of changes that the noble Lord, Lord Winston, was talking about, where the plant adapts to circumstances and has its genes expressed in different ways—were happening overwhelmingly in the bacteria and fungi. It is not the genetics of the wheat plant at all. I do not accept that this is the way to feed the world, without tackling the issues of poverty, inequality, food waste and feeding perfectly good food to animals. We need good management of soils and crop diversity—that is how we feed the world.
I feel a sense of despair at this point; I have no alternative but to withdraw my amendment with great reluctance. I really hope that your Lordships’ House has listened, particularly to the speech by the noble Lord, Lord Winston, and that the Government listen to this as we go forward from here.
Amendment 1 withdrawn.
Amendment 2 not moved.
3: Clause 1, page 1, line 11, leave out from “genome” to end of line 14 and insert “that results from the application of modern biotechnology could have resulted from traditional processes, whether or not in conjunction with selection techniques, alone,”
Member’s explanatory statement
This amendment would limit the test in Clause 1(2)(c) to features of a precision bred organism’s genome that result from the application of modern biotechnology and would require them to be capable of resulting just from traditional processes (whether or not in conjunction with selection techniques).
My Lords, I will begin by speaking to the amendments tabled by the noble Lord, Lord Krebs, whom I thank for his amendments and his ongoing support for the Bill. I will come on to the government amendments in due course.
The noble Lord’s amendment highlights some of the challenges in maximising the potential of plant and animal genomes using traditional breeding methods. The crucial issue is whether the types of genetic features under discussion could, in principle, occur in the genome of the organism by traditional processes. In other places in the Bill, where we intended to refer to outcomes that
“could reasonably be expected to result”
from a process, rather than outcomes that could in principle so result, we have expressly said so. This means that it is unnecessary to add further descriptions to the word “could” in Clause 1. Consequently, the existing wording—“could” have resulted from traditional breeding —already achieves the Government’s intended ambition, without the need for further descriptors in the definition. I believe that it achieves the outcome that the noble Lord wants it to.
Turning to Amendment 7, I understand that the noble Lord tabled it to ensure that fragments of exogenous DNA, such as those that may remain behind after precision editing, do not affect the phenotype of the organism in order for that organism to qualify as precision-bred. I am grateful to the noble Lord for his amendment. However, we have tabled a set of government amendments that would prevent from remaining in the organism any exogenous DNA that was outside the range that can be seen in the existing gene pool. This would ensure that precision-bred organisms contain only changes produced through modern biotechnology that already exist in the genome or could arise through traditional processes. I hope the government amendments that I will now turn to will provide some assurance to the noble Lord and enable him not to press his amendments.
Amendments 3, 5, 6, 8 and 10 aim to clarify which kinds of genetic features are permissible in a precision-bred organism, and the techniques by which they may be introduced. The amendments in this group achieve this by removing references to “natural transformation” in relation to the criteria that determine whether an organism may be considered precision-bred. They also focus the test for a precision-bred organism on the features that result from the application of modern biotechnology, while ensuring that artificial modification techniques that are considered to produce a GMO cannot result in the production of a precision-bred organism.
One of the ways that genomes can be altered naturally is through the process of “natural transformation”—a term that includes the transfer of genetic material from bacteria and viruses to plants and animals through natural infections. It is included in the GMO legislation in a list of techniques that do not constitute artificial modification and so do not result in GMOs. We have included it in the Bill to be clear that natural processes can introduce exogenous DNA into plants and animals and to show how this has been taken into account in defining a precision-bred organism.
Our intention is to strictly limit the type of features that can be present in precision-bred organisms as a result of the application of modern biotechnology. This is done specifically by ruling out some of the changes that occur through natural transformation. This is because natural transformation can introduce longer stretches of functional, exogenous DNA into an organism. An inserted DNA sequence of this type would not be similar to a DNA sequence already present in the organism, or to a sequence that could arise through variation within its gene pool, and, as such, it should not result in a precision-bred organism.
If these kinds of changes are made through the use of modern biotechnology, the resulting organism should be considered a GMO. This is consistent with the advice from the Advisory Committee on Releases to the Environment—ACRE—which says that, for the risk to be considered equivalent to traditionally bred organisms, the genetic change must also be consistent with the type of features that could occur through the use of traditional breeding processes. These are listed in Clause 1(7) of the Bill.
I recognise that the approach we have used to achieve this has caused confusion about which genetic features will be permissible in precision-bred organisms, and has raised concerns that the current text could be misinterpreted. The amendment from the noble Lord, Lord Krebs, which would restrict permissible genetic features with similarity to natural transformation, is designed to better describe these criteria, and I am grateful to the noble Lord for his help and advice in making sure that this clause sets out the desired regulatory test more effectively.
The solution we have reached, with our scientific advisors in ACRE, meets the same aim and, ultimately, achieves the same outcome as the noble Lord, Lord Krebs, intended through his amendment to Clause 1(6). The government amendment removes the term “natural transformation” from the Bill entirely. It takes out Clauses 1(2)(c)(ii) and 1(6). This achieves the desired effect, because the types of features capable of resulting from natural transformation which are acceptable in precision-bred organisms are already captured by the features resulting from the list of traditional processes in Clause 1(7). The kinds of features capable of resulting from natural transformation that are not acceptable would not be covered by this list.
For example, if any DNA remains in the genome of an animal as a consequence of gene editing, it must be similar to the kinds of genetic features that occur in the existing gene pool of the animal, for example as a result of spontaneous mutation. The same would apply to plants. Many plants already contain genetic features that are similar to the short pieces of DNA that are transferred into them as a result of a technique of modern biotechnology called cisgenesis. Again, in these cases, the plant would be classed as a precision-bred organism.
I would like to assure noble Lords that precision-bred organisms will contain only features resulting from the application of modern biotechnology that are similar to those that exist in the gene pool already, or which could arise through the use of traditional processes. In line with advice from ACRE, these features that result from the application of modern biotechnology would not pose a greater risk than those resulting from traditional breeding.
After removing reference to natural transformation from the Bill, the test of whether a plant or animal is classed as a precision-bred organism depends on whether its genetic features that were produced by modern biotechnology are stable and could have resulted from traditional processes. As this test focuses on genetic features that were produced by modern biotechnology, we are also requiring that the organism’s genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology. This ensures that organisms containing genetic features produced through the kinds of genetic modification techniques that cannot constitute precision breeding—in other words, what we would consider classic GMOs—cannot be classed as precision-bred organisms under this Bill.
Through this amendment, we are maintaining our intention for precision-bred organisms to contain only changes that could also have arisen in the gene pool through natural variation or through the kinds of directed breeding programmes already in use today. I am confident that the changes we have introduced are more effective in delivering the scientific approach we have committed to when defining a precision-bred organism.
I will speak quickly to Amendment 9, which the Government have tabled. This amendment is a technical amendment that ensures that subsection (8) reflects the language around the definition of “artificially modified” inserted into Part 6 of the Environmental Protection Act 1990 by the Genetically Modified Organisms (Deliberate Release) Regulations 2002, which is expressed in relation to genes or other genetic material rather than organisms. It would make no substantial change to the Bill.
I hope noble Lords are confident about accepting these amendments.
My Lords, I thank the noble Lord, Lord Benyon, and his officials for the very productive conversations that we have had and thank the Government for tabling amendments that, as he just explained, meet the essential request of my Amendments 4 and 7 in this group. I do not think that there is further debate to be had about the purpose of my amendments, but I thought that I might spend a few minutes, if noble Lords do not mind, explaining what I was talking about with a couple of simple examples. Although he gave a very correct and detailed response, I could see the eyes of one or two of your Lordships beginning to glaze over. I will therefore try to give an illustration.
The logic of my Amendment 4 was that the Bill says —and the noble Lord, Lord Benyon, has just repeated—that a precision-bred organism could have been produced by traditional breeding. My amendment says that while this is true in principle, in practice it may be very difficult to achieve these changes by traditional breeding. The Government’s amendment, in slightly different words, acknowledges that point. I will illustrate why I tabled my amendment with two examples.
Noble Lords will know that cystic fibrosis is an incurable and often fatal disease caused by a single gene mutation. That gene is extremely bad for you, yet one in 25 of us carries that gene, which is extraordinary. After 10,000 generations or more of human evolution since Homo sapiens first emerged, why is that gene still around? If it is so disadvantageous—indeed, fatal—why has it not disappeared? The answer is very simple: traditional breeding—what we do—and natural selection over 10,000 generations has been unable to remove that gene because it is recessive. In other words, most of us who carry the gene—we do not know which ones of us do—show no manifestation of it. If two carriers have children then, statistically speaking, one-quarter of those children will manifest the disease but the others will not. That is the law of Mendelian genetics. Although, in theory, selection and traditional breeding could eliminate the cystic fibrosis gene, the fact is that it does not. But precision breeding could, if we applied it to that example.
My other illustration is on linkage. Genes that live together also travel together, which means that they are passed down through the generations as joined-up twins. One example might be hair colour and eye colour. In general, blond hair and blue eyes go together and brown hair and brown eyes go together, although not always, because those genes for hair colour and eye colour are linked together on the same chromosome but not incredibly closely linked. If they were absolute neighbours, it would be very hard, in the normal process of the reshuffling of chromosomes that occurs during traditional breeding, to separate them. Yet, with precision breeding, you could separate them at a stroke using molecular scissors.
That is what the amendment is about, and I believe that the Government’s amendment has addressed those points with slightly different wording from mine. When I asked Defra officials whether they agreed with the logic of my amendments, they said, “Yes, but our lawyers don’t like your wording.” I defer to the Defra lawyers and accept that they have come up with an alternative form of wording.
Briefly, I move on to my Amendment 7 which, as explained by the noble Lord, Lord Benyon, is about whether having any small fragments of exogenous DNA—probably bacterial DNA—left over after gene editing is a bad thing. The first thing that I need to say to noble Lords in case they are not aware of it is that there is nothing wrong with exogenous DNA. None of us would be alive today were it not for our exogenous DNA. In fact, no multicellular organism on the planet would be alive today were it not for their exogenous DNA. The reason is that, in every cell of our body, there are tiny little organelles called mitochondria, which started life as bacteria. They are not our own DNA; they got into multicellular organisms long before we appeared on the planet 1.5 billion years ago and have been accepted by the host—and, in fact, used by the host to generate energy. The energy that fuels your body and keeps you going is created, second by second in every cell of your body, by these little inclusions that are controlled by exogenous DNA.
Nevertheless quite rightly—echoing the points made earlier by the noble Lord, Lord Winston—we should be very cautious about exogenous DNA that arises from gene editing. The Government had phrasing in the original wording of the Bill that said that this DNA should not code for a protein, which is the normal way that DNA exerts its influence on the body. I said in Committee that DNA can exert its influence on the appearance and functioning of the body in ways other than coding for a protein, so let us take into account a broader definition. Any feature of the organism could have arisen by traditional breeding, to quote the Minister’s words a few minutes ago. I think that meets the purpose of both my amendments, so I do not intend to take things any further.
However, when I asked Jonathan Jones at the Sainsbury Laboratory and Wendy Harwood at the John Innes Centre whether they agreed with my analysis, they said “Yes, John, but the government amendments introduce a new term which could be a hostage to fortune”. That term is “modern biotechnology”. What is modern? I want noble Lords to cast their minds back to the 1990s. When mobile phones first appeared, the ultimate in modernity was to have this thing the size of a house brick in your hand, and with your head bent over because of the strain of holding it you could make a phone call if you were lucky. That was modern technology in the 1990s; just as transgenics was a modern technology in the 1990s, now we consider it a bit old-fashioned. We all have smartphones and think transgenics has been superseded by gene editing. Is it a hostage to fortune to talk about “modern biotechnology” if we roll the clock forward 10 or 20 years and people say, “Gene editing? God, that’s old hat—we’ve got a much more modern system”? Will the Bill still be fit for purpose? I am interested in the Minister’s response to that.
There was another potential hostage to fortune which I think the Minister has dealt with, namely the phrase “artificial modification technique”. As Jonathan Jones and Wendy Harwood pointed out to me, selective breeding by human beings since the dawn of agriculture 10,000 years ago is an artificial technique. It would not have happened naturally; it happened because of the intervention of man. I think that the Minister addressed that on the previous amendment by defining what he meant by artificial technique, but I hope when he comes to respond he will define what he means by “modern biotechnology”.
My Lords, having spoken a great deal on the last group, I will be extremely brief now. What we have is the Government still trying to define what the Bill is about at this incredibly late stage. We have been through Committee, Report and the other stages in the other place and here, and here we are still trying to find the wording. Neither the science nor the law is stable enough for this to become an Act and we have just seen a very useful demonstration in this short debate of how this is very likely to be a field day for lawyers, so the lawyers in your Lordships’ House can get ready.
My Lords, I thank both noble Lords for their contributions to this debate. I particularly thank the noble Lord, Lord Krebs, for his continuing help in trying to get this right. I hope the eyes of not too many noble Lords glazed over. I had to get on the record, about what is undoubtedly a very technical piece of legislation, what we were seeking to do by the changes that we were putting in.
The noble Lord makes a very good point about “modern biotechnology” as a term. I am at great pains not to throw in new definitions that could one day come back to bite us, but “modern technology” is widely recognised to cover a specific set of technologies for regulatory purposes. In particular, it is used in the UN’s Cartagena Protocol on Biosafety. The definition of modern biotechnology can be updated—to be probably even more modern technology—subject to the affirmative procedure under powers in the Bill if required.
I hope that the government amendments, which aim to clarify which kinds of genetic features are permissible in a precision-bred organism and the techniques by which they may be introduced, will provide assurance to the noble Lord not to press his amendments. I hope that noble Lords are confident in accepting these government amendments.
Amendment 3 agreed.
Amendment 4 not moved.
Amendments 5 and 6
5: Clause 1, page 1, line 14, at end insert “and
(d) its genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology.”Member’s explanatory statement
This amendment would introduce a new requirement to ensure that the genome of a precision bred organism could not contain features that result from artificial modification techniques that are not modern biotechnology within the meaning of the Bill.
6: Clause 1, page 2, line 3, leave out subsection (6)
Member’s explanatory statement
This amendment would omit Clause 1(6), which defines “natural transformation”. It is consequential on the Minister’s first amendment to Clause 1 which would remove Clause 1(2)(c)(ii).
Amendments 5 and 6 agreed.
Amendment 7 not moved.
Amendments 8 to 10
8: Clause 1, page 2, line 25, at end insert—
“(7A) An “artificial modification technique” means any technique by which genes or other genetic material can be artificially modified within the meaning of Part 6 of the Environmental Protection Act 1990 (as it has effect from time to time).”Member’s explanatory statement
This amendment would define artificial modification techniques in line with Part 6 of the Environmental Protection Act 1990 (which deals with genetically modified organisms).
9: Clause 1, page 2, line 26, leave out “an organism is” and insert “genes or other genetic material are”
Member’s explanatory statement
This amendment is a technical amendment so that subsection (8) reflects the language of the definition of “artificially modified” in the Genetically Modified Organisms (Deliberate Release) Regulations 2002, which is expressed in relation to genes or other genetic material, rather than the organisms. It would not make a substantive change.
10: Clause 1, page 2, line 35, at end insert—
“(10) An organism to which subsection (11) applies does not fail to be precision bred merely because it does not meet the condition in subsection (2)(d).(11) This subsection applies to an organism which, for the purposes of Part 6 of the Environmental Protection Act 1990, is to be taken not to be a genetically modified organism by virtue of—(a) paragraph (3) of the regulation referred to in subsection (8)(a), or(b) regulations under subsection (4C) of section 106 of that Act.”Member’s explanatory statement
This amendment would ensure that an organism will not fail to be a precision bred organism by reason only of the new test introduced by the Minister’s second amendment to Clause 1 if it is to be taken not to be a genetically modified organism by virtue of the provisions referred to in subsection (11)(a) and (b).
Amendments 8 to 10 agreed.
Clause 3: Restrictions on release of precision bred organism in England
11: Clause 3, page 3, line 24, after “unless” insert “, in relation to a precision bred animal, the date condition in section (Entry into force of provisions relating to animals) has been met, and unless”
Member’s explanatory statement
This amendment would prevent a precision bred animal from being released unless the date condition in a later Clause in the name of Baroness Hayman of Ullock has been met. Taken collectively, these amendments would ensure a phasing in of the animal provisions in the Bill.
I thank the Minister for his response to my amendment and I am pleased that he reaffirmed the Government’s ambition to phase in different species. The problem is that it is not actually in the Bill, so there is no guarantee that it will happen. I would also like to come back to him on this: the amendment is not designed to restrict. If scientific evidence supports this application, it will not restrict it. I thought I had made that clear. Also, if the Minister believes that the introduction of animals is likely to be later than the date in my amendment, I really do not understand the reluctance to accept this and have it in the Bill. On that note, I would like to test the opinion of the House on my Amendment 11.
12: Clause 3, page 3, line 30, at end insert—
“(iv) the details of the gene editing event, and the record of the whole genome sequence of the qualifying organism, are recorded in a publicly available register established by regulations,”
My Lords, in moving Amendment 12, I will speak also to Amendment 13 in my name. This is an adaptation and development of the work done by the noble Lord, Lord Winston, in Committee—he is not currently in his place; I hope he will be back in a second—when he put forward the idea of a register. This is my attempt to write that register into the Bill, to establish full transparency and traceability around gene editing.
The drafting is my own, although I thank the Table Office for its help. I will not claim that this is the perfect way to set this in the legislation, but in this legislation it absolutely should be, for the sake of transparency and traceability. We are giving commercial companies the right to mess around with the basis of life on earth. Showing their working and allowing the knowledge to be available to others is a small price to pay.
The noble Lord, Lord Krebs, and I had a detailed debate in Committee about whether it is possible to identify gene-edited organisms; some aspects of that debate remain in dispute, but we heard on Friday’s call that, should the nature of the gene-editing event be recorded, as Amendment 12 calls for, there is absolutely no doubt that any gene-edited organism can be identified.
This amendment goes further in calling for the record of the whole-genome sequence of the qualifying organism to be recorded. For the House’s information, I think it is worth going a little further into that, and into an explanation of why the regulations should be covered by the affirmative procedure.
Whole-genome sequencing can accurately identify the full spectrum of unintended mutations at both off-target and on-target editing sites, including the inadvertent insertion of foreign DNA. Given what we heard from the Minister in the last group, I am not sure how we can be sure than an organism is legal if we do not have this. Multiple-reference genomes derived from the whole-genome sequencing of major crop plants are available already in the public domain. That has yielded important information about the unintended effects of gene editing on the genome. For example, in a study on gene-edited rice using CRISPR-Cas, whole-genome sequencing was used to investigate unintended mutations arising from several aspects of the gene-editing procedure. The procedure, which taken as a whole includes tissue culture and Agrobacterium-mediated cell transformation, resulted in several times more unintended mutations than were found in rice propagated through natural pollination. If you do not do the whole-genome sequencing, you simply cannot know that to be the case.
We are sometimes told that this is too complicated, difficult and expensive. We have been talking about how fast this field is moving, and one recent innovation is what is known as long-read DNA sequencing. Unlike many things in this area, its meaning is pretty clear-cut from its self-description. It provides a continuous sequence that reads up to 1.5 million DNA base units and would provide unequivocal understanding of the placement of long stretches of repeat sequences, which some of the older methods that break up the DNA strand do not do so easily. Several companies offer a long-read genome sequencing service, making this technology readily available.
I did not write this into the Bill, and it is another reason why I put in the affirmative procedure, but this register could also include requirements for molecular compositional profiling methods: gene expression-profiling transcriptomics, protein-profiling proteomics and small biochemical molecule-profiling metabolomics—let us call them “omics”. These are now used by thousands of research groups around the world to gain a more comprehensive and deeper insight, not just into the genome but into how an organism functions. It is crucial to understanding the health and disease implications of the genome to see how that genome plays out in the proteins in the cells.
A 2016 research paper published in the extremely prestigious journal Nature used a multi-omics approach to demonstrate that a glyphosate-tolerant GM maize was not substantially equivalent to its non-GM relative. The large-scale protein and metabolite alterations that were detected were unintended consequences of the GM transformation process, with potential downstream health consequences for the consumer in terms of the introduction of toxins and allergens.
I see that the noble Lord, Lord Winston, is here and I refer Members of your Lordships’ House to his speech in this area and our discussion in Committee. To know what is going on is scientifically and practically essential. That is why I have tabled these amendments. I do not intend to move to a vote, but this is a matter that the Government should commit to. It is interesting that in our discussion on Friday with all the experts one of them said to me, “Yes, there is a public register. At least that’s how it’s going to work”. I do not know whether the Minister can explain this, but my understanding is that there is nothing in the legislation that provides for a public register. If I am wrong, I am happy to be corrected. However, these people are proponents of the Bill and this procedure, and they believe that there will be a public register. If that is what the experts are trusting in and want to be able to use—it is a public resource—and if it is not already there, the Government certainly should introduce it. I beg to move.
I thank the noble Baroness, Lady Bennett, for introducing the amendment because it gives me a chance to say two things quickly. One, which she alluded to, is our discussion in Committee about detectability by analytical methods. I asked Wendy Harwood from the John Innes Centre to give me an exact form of words about that, which I shall repeat with her permission. It confirms, in a way, what the noble Baroness has just been saying. Wendy Harwood said:
“If you had details of the exact edit made, then you could detect”
the PBO by polymerase chain reaction,
“followed by sequencing of the PCR product. If you were just presented with a plant, and no audit trail and asked whether it was genome edited, you could not determine whether it was or not.”
One therefore needs an audit trail in order to be able to tell. She continued:
“If exactly the same change had been made by precision breeding as had been made by traditional breeding, and you tested by looking for that precise change, then you would not be able to tell which was which. Again an audit trail would be required. You might however have a case where both PB and traditional breeding had made changes to the same gene, giving the same trait, but these changes were not identical at the DNA level, in this case you could tell the difference.”
That emphasises that if one is serious about knowing which products on the shelves are produced by PB, there needs to be an audit trail.
On whether whole-genome sequencing is of value, one angle is that so much mutation in the genome is going on all the time that it is hard to know what one’s reference material would be. The Royal Society produced in its evidence to the Defra consultation a calculation that in a hectare of wheat there would be at least one mutation for every base pair in the wheat genome. There are 10 billion base pairs in a wheat genome. In a one-hectare field of wheat, there would be a mutation somewhere in every one of those base pairs. So the difficulty with using whole-genome sequencing is what one makes of the information one gets. There will be huge variation and one does not quite know what the value of the information is.
I think we have agreement that some parts of the genome are functionally relevant and have a particular functional significance. We perhaps have points of disagreement about how relatively protected some of those may be from natural mutations. There are lots of mutations that happen naturally in areas that may be beneficial to the plant but only in certain parts of the genome and with certain sorts of functional effects. The parts of the genome that are particularly crucial to the function of the organism are the structural, basic ones, where there are far fewer natural effects. If you read the complete list of the genome, you are going to look at certain bits to see which changes are significant, which ones may be deleterious and which ones are less significant. Does the noble Lord agree?
Obviously, I agree that the different parts of the genome serve different functions. As the noble Baroness said in Committee, when we were students, we learned about junk DNA. However, it is not junk DNA; it can play an important part in regulating the expression of other genes. I take the point.
I love the idea of the noble Lord’s field of wheat waving gently in the breeze and the sunlight, but does he not agree that certain genes in those wheat seeds are rather well conserved and, in fact, do not change? Indeed, certain genes are protected from mutation. Therefore, there is nothing to prevent us looking at analysis to see the frequency of certain mutations within the genome; perhaps we need to be doing that. The data there could be very useful in all sorts of ways.
My Lords, this group of amendments deals with technical scientific issues and moving whole or parts of clauses from the negative procedure to the affirmative. Your Lordships will know that I am not a scientist so I shall, I hope, avoid digging a hole for myself or getting caught in the crossfire.
Amendment 12, in the name of the noble Baroness, Lady Bennett of Manor Castle, would require the details of genome sequencing to be recorded in a publicly available register. If the processes outlined in this Bill are to be carried forward successfully, it will be necessary for farmers, producers and the public especially to have confidence in the process. Ensuring that there is transparency and visibility through a publicly available register can only help this process. The DPRRC was strongly in favour of such a register in its report of 2 December.
Amendment 13, also from the noble Baroness, Lady Bennett, seeks to make the whole regulation in Clause 3 affirmative. Currently, the Bill is silent on whether Clause 3 is affirmative or negative. I suspect that, as it currently stands, Clause 4(6) applies to the whole of the section headed “Release”.
I am grateful to the Minister for his amendments in this group. At Second Reading and in Committee, concerns were raised at the number of negative procedures in the Bill. The Minister has tabled government Amendments 14 and 15 to Clause 4, which would qualify the section on marketing and keep subsection (1)(b) as negative while the rest of this clause will be moved to the affirmative procedure. This is welcome and gives the opportunity for debate on the notification requirements if necessary. Perhaps the Minister can clarify in his response whether Clauses 3 and 4 are covered by his Amendments 14 and 15. If not, can he say what process is applied for Clause 3? I am sorry; I may have misunderstood what this is all about.
Amendment 16, to Clause 6(4), moves regulations on the precision bred confirmation from negative to affirmative. We welcome the Minister’s movement on this point. This is a sensible way forward and, again, gives the opportunity for further debate.
Government Amendments 24 and 25 are somewhat confusing. Amendment 24 indicates that the regulations under Clause 18(1) are to be affirmative, and Amendment 25 deletes “this section” and inserts “subsection (6)”. I think this means that Clause 18(1) is affirmative while the rest of the clause is negative, as Clause 18(7) has not been amended. I would be grateful for the Minister’s clarification. It is important for when we come to debate these things later to know whether it is affirmative or negative. Although these are technical amendments, they are very important and provide transparency in the Bill, which is to be welcomed.
My Lords, the noble Baroness, Lady Bennett, has tabled two amendments. Amendment 12 concerns the publicly available register. Clearly, transparency and information for the public will be important if we are to carry people with us, so we need to look at how we develop registers and information to reassure people and to give them the information that they need to have confidence in the legislation.
In Committee, my noble friend Lord Winston and the noble Baroness, Lady Parminter, drew 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 the positive and the adverse outcomes, on individuals used under the terms of that Act. The noble Lord, Lord Krebs, read out an opinion which emphasised the importance of an audit trail, so there is a general feeling in this House that information and a public register are important.
Amendment 13 is also in the name of the noble Baroness, Lady Bennett. I thank the Delegated Powers and Regulatory Reform Committee for its report on the Bill, which was very helpful. I reassure the Minister, who knows that we support the Bill, that what concerns us is that so much is left to an unknown number of SIs over an unspecified timescale. If the regulations in Clause 3 are under the affirmative procedure, Parliament will rightly have a formal role in improving the finer details of the release and marketing notices, crucially ensuring that we have proper political consensus on this. As the noble Baroness, Lady Bakewell, said, the Government have moved a number of clauses from the negative to the affirmative procedure. I will not go into all the detail, as she covered everything that I was going to ask about on this, since some of it is not crystal clear. We know that the Government can see that there is merit in moving from the negative to affirmative. Can the Minister clarify why not this clause as well if that is not the case, as this is important?
My Lords, I thank the noble Baroness, Lady Bennett, for her Amendment 12, which would require details of the specific gene editing event and the whole-genome sequence of a qualifying precision-bred organism to be made publicly available for its release into the environment. The noble Baroness’s Amendment 13 to Clause 3 would require that regulations made under this clause to establish a public register containing this information are subject to the affirmative procedure.
It is not our intention to require breeders to include sequence data as part of their release or marketing notices. I have discussed this previously following an amendment tabled by the noble Lord, Lord Winston, in Committee. We have since had a very useful meeting with the noble Lord and our scientific advisors, ACRE, to explore why whole- genome sequencing information has limited value in most cases, and the noble Lord has not retabled his amendment on Report.
This type of information has limited value because there is a significant degree of genetic variation between individual plants and animals within a species, which is more or less the point that the noble Lord, Lord Krebs, was making. This amount of background noise means that the value in requiring whole-genome sequences is limited in terms of addressing regulatory questions; for example, questions about the precision-bred status of a plant or animal. Additionally, the release notice that researchers are required to submit to Defra will be in line with the requirements of the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022, which were agreed by the affirmative procedure.
Our intention is that information provided in release notices will be published on the precision breeding register and will include the relevant and necessary information about the precision-bred organism in it. We also intend to require developers to confirm that the organisms that they intend to release in research trials meet the criteria in the Bill. The technical details of this notice will be prescribed by regulations, prepared with input from the advisory committee appointed to advise the Secretary of State on the regulatory status of these organisms and, in accordance with the amendments to Clause 4 that I have tabled, our intention is that such regulations will be scrutinised using the affirmative procedure before they are made.
I hope that this reassures noble Lords and that the noble Baroness, Lady Bennett, is persuaded to withdraw this amendment and not move her additional amendment to Clause 3, which would specify the parliamentary procedure for the delegated power that her substantive amendment would insert.
I always pay particular attention to points raised on secondary legislation by the noble Baroness, Lady Bakewell. As a member of the Secondary Legislation Scrutiny Committee, she is very good at holding me to account on these. I did not quite understand her point about Clause 3 because there are no regulations in Clause 3 and therefore no requirement for it to be affirmative or negative.
We remain of the belief that the matters to be set out in the regulations under the powers in Clauses 4(3) and 6(2) are administrative in nature. However, the Government acknowledge that these provisions are of significant public interest. We have heard this previously in the House and the Delegated Powers and Regulatory Reform Committee has raised this as well. We have considered these matters closely and have decided to change the procedure from negative to affirmative for both powers. These changes will increase the scrutiny when these powers are used to prescribe the information which must be provided to the Secretary of State by a person who wishes to release or market a precision-bred organism. I hope that noble Lords feel that I was serious in Committee when I said that I had listened to them. I hope that they feel that this improves the Bill. Regulations under Clause 4(1)(b) would be administrative in nature, not of significant public interest, and will remain subject to the negative procedure. I hope that this reassures noble Lords.
Amendments 24 and 25 will increase the level of scrutiny when powers are used to prescribe information that must be included in the precision breeding register. The Government acknowledge that these provisions are of significant public interest. We accept noble Lords’ concerns about the level of scrutiny for such provisions. Therefore, we will change the parliamentary procedure from negative to affirmative for the power in Clause 18(1). Regulations under Clause 18(6) regarding the keeping of the register, which is an administrative matter and, again, not of significant public interest, will remain under the negative procedure.
My Lords, I thank the Minister for what he has just said, but can he answer this question about whole-genome sequencing?
When we first started genome sequencing, it was laborious, expensive, time-consuming, and so on. It is now a pretty rapid process and can be done without huge expense. Does the Minister not agree that one of the reasons for doing this is not just marketing—because of course there are different issues there, which is how we are addressing this—but the advantage of getting more knowledge about what we are doing? The advantage there would be seeing where things are moving within the organisms that we are trying to edit. That is important as a research tool because, ultimately, we are doing something that—admittedly—we do not fully understand, and this would greatly increase knowledge. Does he feel that this is a relevant point?
It is entirely a relevant point, and was much on our minds when we debated some months ago a research measure in secondary legislation to allow the development of plant precision editing but not for it to be taken forward to market. The noble Lord is absolutely right that this is fast-moving and that we therefore need to be clear about how we regulate: that we are regulating a research process and a process to take products to market. Ministers will have to be clear about the intention of the organisation taking that forward. I hope, through the changes that we made, that there will be greater parliamentary scrutiny, that people with real knowledge, particularly in this place, will be able to scrutinise that, and that the Secretary of State of the day will have the best available information about what is being taken forward and why—whether it is just for research. The point made by the noble Lord about the value of research of products that will never go to market, that it is just to understand a particular aspect of genomic sequencing, is crucial.
My Lords, I thank the Minister for his answer, and everyone who contributed to this debate. Once again, the noble Lord, Lord Winston, gave us the expert nailing of the issues. I thank particularly the noble Baronesses, Lady Bakewell of Hardington Mandeville and Lady Hayman of Ullock, for stressing the importance of transparency, both for scientific and public confidence reasons.
The Minister went over some of the same ground that the noble Lord, Lord Krebs, and I circulated back and forth on in terms of saying “Oh, there are lots of mutations” is not a reason not to do whole-genome sequencing. What we see are the mutations that are of greater importance in particular areas of the genome, et cetera, so the claim that “Oh, there are lots of mutations, so it doesn’t matter” does not scientifically stack up.
We are in a situation of regulations. The Minister said that the regulations will specify that the release notices contain “relevant and necessary” information. I think it is already clear that the detail of what “relevant and necessary” actually means is going to be crucial. We all know the problem with regulation and the way in which we are given it on a take it or leave it basis. Again, I feel great reluctance: I feel that we really should have whole-genome sequencing, and indeed broader omics testing. But I see no option at the present moment but to withdraw the amendment, with great reluctance.
Amendment 12 withdrawn.
Amendment 13 not moved.
Clause 4: Release of precision bred organism: notification requirements
Amendments 14 and 15
14: Clause 4, page 4, line 24, leave out “this section” and insert “subsection (1)(b)”
Member's explanatory statement
This amendment is consequential on the Minister’s next amendment to Clause 4.
15: Clause 4, page 4, line 24, at end insert—
“(7) Regulations under subsection (3) are subject to the affirmative procedure.”Member's explanatory statement
This amendment would provide for regulations under Clause 4(3) to be subject to the affirmative procedure.
Amendments 14 and 15 agreed.
Clause 6: Application for precision bred confirmation
16: Clause 6, page 5, line 31, leave out “negative” and insert “affirmative”
Member's explanatory statement
This amendment would provide for regulations under Clause 6(2) to be subject to the affirmative procedure.
Amendment 16 agreed.
Clause 11: Application for precision bred animal marketing authorisation
17: Clause 11, page 8, line 24, at end insert—
“(9A) Regulations under subsection (5) are subject to the affirmative procedure.”Member's explanatory statement
This amendment would provide for regulations under Clause 11(5) to be subject to the affirmative procedure.
My Lords, I thank the noble Baroness, Lady Jones of Whitchurch, for her amendments, to which the noble Baroness, Lady Bakewell of Hardington Mandeville, and—in the case of the first of the amendments—the noble Lord, Lord Cameron of Dillington, have added their names.
The amendments require the animal welfare advisory body, when assessing precision-bred animal marketing authorisation applications, to also consider and report on the notifier’s history of compliance with relevant provisions of the Human Fertilisation and Embryology Act 1990, the Animal Welfare Act 2006 and other legislation it deems relevant. However, the purpose of the animal welfare declaration process is not to vet notifiers themselves, but to assess their applications for marketing authorisations. The role of the welfare advisory body is to use its scientific expertise to evaluate the notifier’s animal welfare declaration. It would not be an appropriate body to assess compliance history.
We expect notifiers, as with any other keepers of animals, to ensure they are in full compliance with all applicable animal welfare laws. The Animal Welfare Act, as mentioned in the noble Baroness’s amendment, will continue to apply to all vertebrate animals subject to precision breeding. Under the Act, it is already an offence either to cause any captive animal unnecessary suffering or to fail to provide for the welfare needs of the animal. Persons found to have committed certain serious offences under the Animal Welfare Act may be disqualified from keeping animals. Such persons would therefore be unable to keep animals that have been precision-bred.
Similarly, other animal welfare legislation provides for appropriate sanctions for non-compliance. For example, notifiers may also be licence holders for research under the Animals (Scientific Procedures) Act, known as ASPA. It is in the interest of such notifiers to ensure that any research involving animals carried out in the UK complies with the requirements of the ASPA licences relating to that research; these licences may be revoked or suspended if their conditions are not complied with.
Furthermore, the Bill provides powers under Clause 15 for regulations to enable the Secretary of State to suspend or revoke a precision-bred animal marketing authorisation if new information about the health or welfare of the animal or, crucially, its qualifying progeny comes to light, or if the notifier fails to comply with a legal requirement to report information about a relevant animal’s health and welfare under Clause 14. Regulations will describe the procedures to be followed when a marketing authorisation is suspended or revoked, and the consequences of such suspension or revocation.
Amendment 21 reflects ones put forward during previous stages, in this House and the other place. We intend to explore these matters further as we develop the technical details underpinning the animal welfare declaration process. The Government agree that safeguarding animal welfare is crucial, and I acknowledge the high level of interest in this topic. That is why, as I mentioned previously, we have commissioned an external research project to gather the evidence required to develop the health and welfare assessment that underpins the declaration process. This will enable us to set out, in regulations and guidance, the information that a notifier must provide to support their declaration that the health and welfare of a precision-bred vertebrate animal is not expected to be adversely affected.
Furthermore, Clause 13 already ensures that the Secretary of State will need to be satisfied with the animal welfare declaration before issuing a marketing authorisation. That is why we do not consider the amendment to be necessary. In addition, as I mentioned before, the power in Clause 25 allows us to set out in regulations what constitutes an adverse effect on health or welfare. This includes any parameters needed for assessing that and could include consideration of any known health and welfare issues in selectively bred animals.
Finally, the welfare declaration and the welfare advisory body’s assessment will be based on the principle that relevant precision-bred animals will need to be kept in conditions which satisfy existing requirements in the Animal Welfare Act 2006 and, where relevant, the Welfare of Farmed Animals (England) Regulations 2007. I fully understand the noble Baroness’s concerns. None the less, existing animal welfare legislation is in place and the Bill is intended to work alongside that to enable responsible innovation.
I will now address Amendments 17, 18 and 26 in my name. It is essential that the animal welfare protections under this Bill command strong public and stakeholder confidence. To that end, we have listened carefully to the points raised by the Opposition and stakeholders about the need for strong animal welfare protections. We understand that noble Lords feel that there should be more opportunity for parliamentary oversight of these vital elements of the legislation. Consequently, we are tabling these amendments so that regulations made under the powers in Clauses 11(5) and 22(3) will need to be debated and actively approved by both Houses of Parliament through the affirmative resolution procedure before they come into effect.
Amendment 17 relates to Clause 11(5). The amendment provides an increased opportunity for parliamentary scrutiny when powers are used to lay out the form and content of the animal welfare declaration and accompanying documents, and the information that must accompany the declaration.
Regulations under Clause 11(9) regarding provisions for an application for a precision-bred marketing authorisation to be made by a person other than the notifier are a technical and administrative matter and not of significant public interest. They will therefore remain subject to negative procedure.
Amendment 26 relates to Clause 22(3). This amendment will provide Parliament with an increased opportunity to scrutinise and debate the body which is to be designated as the animal welfare advisory body, while retaining the flexibility the Bill provides on how the advisory body can be established. We expect there to be strong public interest in the requirements set out in the animal welfare declarations, and we want to come to Parliament with a robust set of proposals informed by expert advice. Indeed, that is why we have already commissioned in Scotland’s Rural College to run an independent research project to set criteria for the animal welfare assessment and the evidence that will be required to accompany it.
The research will involve experts from the Animal Welfare Committee and a wide range of organisations with expertise in animal welfare, genetics and industry practice. This is a growing, innovative sector, and the regulatory system that oversees it is likely to need to evolve over time. Establishing the regulations in secondary legislation subject to the affirmative procedure will allow the Government to ensure that the regulatory system continues to achieve its goals in the long run, while maintaining proportionate parliamentary oversight of its design and future development. I hope noble Lords will be content to accept these amendments.
My Lords, I should first declare an interest through my involvement at Rothamsted, as in the register. I have tabled Amendments 19, 20 and 21 in this group. They all focus on the welfare advisory body in protecting animal welfare. I am grateful to the noble Baroness, Lady Bakewell, and the noble Lord, Lord Cameron, for their support.
Amendments 19 and 20 would require the welfare advisory body to look beyond the information provided by applicants to ensure that they have a consistent record of meeting animal welfare standards, as set out in previous legislation. Amendment 21 would require the welfare advisory body or the Secretary of State to consider wider health and welfare issues before granting a marketing authorisation. These factors, set out in the new clause, include the direct and indirect effects on the health of the animal or its offspring, whether there might be pain or suffering arising from increased yields or faster growth, and whether the precision-bred traits may result in the animal being kept in worse conditions. These amendments reflect the widespread concern raised in Committee about the consequences for animal welfare of extending precision-breeding techniques from plants to animals, and they also express the concerns of many animal welfare organisations, including the RSPCA and Compassion in World Farming, as well as the report from the Nuffield Council on Bioethics.
As we discussed before, British farming and traditional breeding techniques have not always had a great record on considering animal welfare. Without going back over all the arguments raised in Committee, I will say that there remains a fundamental concern that the genetic editing of animals will be used for the wrong purpose. Once we understand that there could be benefits from improved disease resistance in animals, we need better guarantees that this will not result in animals being kept in more crowded, stressful conditions, which in turn could result in the spread of new and emerging pathogens. Similarly, we need better guarantees that precision-breeding techniques will not be used to speed up selective breeding for fast growth, high yields and large litters, when they have historically caused a great deal of suffering to farm animals, despite the animal welfare legislation already in place.
All these concerns are raised against the backdrop that so much of the detail in this Bill is left to secondary legislation, so we do not know how its provisions will work in practice. I hope the Minister will understand why we are trying to spell out in more detail the specific animal welfare protections in this Bill. I shall make a further point: this is specifically about animal welfare. It is not a criticism of the whole Bill. It is about the specifics and our widespread concern about wanting to get animal welfare protections right.
In his response in Committee, the Minister talked about getting the right balance of information between the welfare advisory body and the notifier requesting the marketing authorisation, but we do not believe that what is set out in the Bill is the right balance. It does not allow the welfare advisory body to make the wider checks on the past record of the notifier that our amendment would allow, and the Minister had just said that he does not think that it is the role of the welfare advisory body to do that vetting. We argue very much that it is its role.
The Minister also argued that it is important to balance innovation with animal welfare. He argued this in Committee. He said that setting out parameters in more detail in the Bill could limit the implementation of more detailed measures that will follow—but this is precisely our concern. Moving from genetic plants to genetic animals is a huge ethical and environmental step, and it is right that the protections are spelled out in the Bill, where Parliament can have some control.
In Committee, the Minister referred to Clause 11, which requires applicants to make a declaration that they do not expect the health or welfare of an animal to be adversely affected. Well, in the words of a well- known quote, “They would say that, wouldn’t they?” The Minister also referred to Clause 14, which provides for further information to be required on animal health and welfare, but the clause states only that regulations may be made. There is no guarantee that they will be produced or what the additional information will be. The Minister also said that the Bill is intended to work alongside existing animal welfare legislation, but as it stands it does not empower the welfare advisory committee to cross-reference the notifier’s compliance with those regulations. In fact, the whole emphasis of Clause 12 is for the welfare advisory committee simply to scrutinise the information provided by the notifier rather than make any wider checks.
The Minister also sought to reassure us that the Government have an ambitious reform agenda for animal welfare, but I remind him that we are still awaiting legislation on many of the reforms promised in the manifesto.
So we believe that these amendments are proportionate and necessary. As the Bill stands, there is too much left to chance. There is nothing to ensure that the welfare advisory committee will be proactive and inquiring. In fact, the Minister, in his call for balance, does not want it to be too proactive in case it holds things up. There is far too much left to future regulation that may or may not happen. All these amendments do is ensure that the welfare advisory committee looks at the background of applicants to check that they are complying with existing animal welfare legislation and give the committee greater powers to investigate the impact of precision-bred techniques on the consequent pain, suffering and lasting harm to animals and the conditions in which they are kept.
We believe these additional protections will have broad public support, as well as being in the interests of the animals involved. We welcome the fact that the Minister has set up this external body to give further advice. That does not go against the amendments that we have tabled. It may be that there are further regulations that need to come after this Bill goes through. That is fine, but it does not militate against our amendments at this time. I therefore give notice that, depending on the Minister’s response, I may be minded to test the opinion of the House.
My Lords, I thank the Minister for tabling Amendments 17, 18 and 26. The Government have responded well to the concerns expressed in Committee about the number of negative procedures on some critical issues. Amendments 17 and 18 relate to Clause 11, “Application for precision bred animal marketing authorisation”, which is a key element of the Bill. Regulations under subsection (5) are moved to affirmative, and only subsection (9), which deals with regulations for precision-bred animal marketing authorisations for a relevant animal, are negative and reserved to the Secretary of State. While it would have been preferable for all that clause to be affirmative, we are pleased with this movement, as the change allows more debate on these issues in future.
I turn now to Amendments 19 and 20 in the name of the noble Baroness, Lady Jones of Whitchurch, to which I have added my name—she introduced them fully, as always. The Government have been trying for a long time to introduce gene editing of plants and animals. Changing the name of this process to “precision engineering” has somewhat helped their case. At the heart of previous and current objections which have been raised over time against precision engineering is animal welfare.
Whenever a man, woman or child is to undergo a surgical or medical procedure, numerous forms have to be completed, and a consent form signed; in the case of a child, a parent or guardian signs. Animals undergoing genetic change have no such individual guardian, and they certainly cannot speak for themselves. It is therefore necessary for those of us in this Chamber to ensure that safeguards and trust are in place which will be robust. This trust is placed in the welfare advisory body. The noble Lord, Lord Winston, referred to ethics in his comments on the first group of amendments, and the issue runs all through the Bill. The process is that the notifier applies to the Secretary of State for an authorisation in relation to an animal, and the Secretary of State then refers the application to the welfare advisory body, which in turn provides a report for the Secretary of State. Amendment 19 requires the welfare advisory body to ensure that the notifier has a record which provides the necessary reassurance that animal welfare will not be compromised in any way. Precision engineering can take place, but not at the expense of the animal’s suffering. Amendment 20 is consequential on Amendment 19.
The noble Baroness, Lady Jones of Whitchurch, has also spoken to her Amendment 21, which proposes a new clause. This lists some additional factors which the welfare advisory body or the Secretary of State must consider before granting a marketing authorisation. The Minister has said that he does not feel that this is necessary, but such is the interest in the Bill and the consequences which flow from it that we believe a belt-and-braces approach is necessary.
We on these Benches do not wish to interrupt the passage of the Bill, but we support all efforts to ensure that animal safety and welfare are protected. This is not the stage of the Bill at which to relate cases of experimentation on animals which have gone horribly wrong and ended with considerable suffering to the animals concerned. Animal welfare is our prime concern, and I look forward to the Minister’s response, but if the noble Baroness, Lady Jones, is not satisfied with it and decides to divide the House, we will support her.
My Lords, for the purposes of Report, I declare my interests: I am still involved in a family farming enterprise growing crops and rearing livestock, I chair the board of the UK Centre of Ecology & Hydrology, and I am president of the Royal Association of British Dairy Farmers.
As the House knows, I am a very strong supporter of the Bill and everything it stands for. It is only to strengthen the Bill that I have added my name to Amendment 19 tabled by the noble Baronesses, Lady Jones and Lady Bakewell, because here again we touch on the same weakness in the Bill that I referred to at earlier stages—notably, the oversight of the ongoing welfare of animals and their ensuing progeny affected by these processes. As I said at Second Reading:
“To my mind, however, there is too much responsibility, certainly in the latter stages of the proposed development process, for the notifiers themselves to keep the welfare advisory body informed. It appears that the notifiers are in the driving seat.”—[Official Report, 21/11/22; col. 1218.]
These notifiers will be the ones who have probably invested millions of pounds, and almost certainly years of man-hours and academic endeavour in the process, and will therefore be very strongly motivated to ensure that the results give them some sort of positive return. I am not saying that they will necessarily falsify the evidence, although that may not be beyond the realm of possibility, but they will surely be sorely tempted to slant the results—if only for the sake of their commitment to what they see as the greater good. For instance, one person’s definition of bovine, ovine or avian distress might be another person’s idea of, say, satisfactory close family living. Therefore, it is essential that the welfare advisory body has the duty to audit and check up on these notifiers.
I know that the Government—any Government—have a priority to repel all boarders when it comes to amendments to their legislation, but I cannot see how or why they would want to tell the public that their new welfare advisory body would not have an obligation to check up on and satisfy itself that the notifier is conforming to the codes of practice set out in existing legislation. I am sure that the Government will tell us that this is not necessary—in fact, they have already done so—that there are other bodies involved, and that the notifiers already have an obligation. However, unless the welfare advisory body has a specific duty to check on and audit the notifier, it is quite possible that such persons or bodies could slip through the Met. Oh! That is not necessarily a Freudian slip—I mean “the net”, of course, but after last week’s revelations about rogue policemen I expect you can see how my mind is working. The welfare advisory body needs a specific duty spelled out in the legislation to ensure that there are no rogue notifiers.
I hope that the Government will see fit to accept this amendment, or undertake to discuss a positively worded government replacement amendment to be introduced at Third Reading, either for Amendment 19, to which I put my name, or Amendment 21, or indeed Amendment 22 in the next grouping. There has to be some give here on their part to persuade me, and I would like to think to persuade the House, that a vote on this matter of animal welfare is not necessary.
My Lords, during the proceedings on the Bill—I spoke at Second Reading—it has been clear that some people, both inside and outside the House, do not want anything to do with genetics in terms of food production, and think that its application is anathema. I understand that and I do not blame them in the least, although I do not agree with it, but I have been looking at Amendment 21 in the name of the noble Baroness, Lady Jones of Whitchurch, and I ask her whether she thinks that the provision in proposed new subsection (3)(b) might well give an opportunity for one of those people. Its wording is about progeny being
“likely to experience … lasting harm”
resulting from “faster growth” If you take that to its logical conclusion and encourage faster growth in an animal used in the meat trade, it is fairly clear that the animal will become suitable for slaughter at an earlier stage than if it had not had the influence of genetics. If you create faster growth by the application of genetics that ends up with the animal having a shorter life, is that not lasting harm? Some people could argue that, and I ask the noble Baroness if she would like to comment on that question.
I am not sure if this is the right moment to speak, but, in answer to the noble Lord’s specific question, the amendment is saying only that the welfare advisory body should take that into account. If there were other overriding reasons why we would want to have faster growth, for example, then that would be a balanced decision that it would make. However, if the faster growth were indeed leading to more pain, we hope it would take that into account. That is what the animal welfare role ought to be about. In Committee we heard lots of examples of new breeding techniques causing considerable pain, but I hope we are moving away from that now and can have a more generous attitude towards both conventional breeding and, potentially, the genetic breeding of animals where it does not have that effect. So it is all about the balance, and this is just one factor that the welfare advisory body will take into account.
My Lords, I declare my interests as a tenant farmer and as chairman of the Rock review into England’s agricultural tenancies.
The Government’s procedural amendments will increase parliamentary oversight of the design and future development of the animal welfare provisions. The Government recognise that there is a need to safeguard animal welfare, and that is why we need a step-by-step approach by bringing legislation into effect for precision-bred plants first and then for animals. Research in farmed animals is already leading to the development of animals that have increased resistance to some devastating diseases that, as farmers, we all see, and it thereby enhances the health and welfare of animals.
My Lords, I welcome the government amendments that move the regulations to the affirmative procedure; they are extremely welcome.
I thank my noble friend Lady Jones of Whitchurch for her thorough introduction to her Amendments 19 to 21. I am sure noble Lords will remember that in Committee I tabled a number of amendments relating to the welfare advisory body, so we are very pleased to see my noble friend Lady Jones tabling similar amendments today. I spoke at length on this issue in Committee, my noble friend has introduced her concerns and we have heard from across the House, so I shall be brief.
Amendment 19 makes it clear that, in addition to considering information submitted by the notifier, the welfare advisory body should satisfy itself that the notifier has a record of acting in a manner that is consistent with research and animal welfare requirements across other Acts of Parliament. That really should be part of the body’s role. We do not want any confusion or different decision-making across different bodies.
I may have this recollection wrong, but I thought that in an earlier meeting a flow chart was mentioned showing how different animal welfare bodies, in Defra and the Home Office, would interact. I had been hoping to receive a copy of that to get some clarification about precedence and how this was all going to work together. It may have gone into my spam folder and I may have missed it, but if the Minister could check on that, that would be very helpful.
Currently, the Bill states that the welfare advisory body has to determine whether in the animal welfare declaration the notifier has paid regard to the risks to an animal. One of my concerns has always been that it is the notifier who is driving the process and is in the driving seat, rather than the welfare advisory body, which is why we were all very concerned about more checks and balances. We know the Bill says that the notifier has to take reasonable steps to assess those risks, but we do not believe that is a strong enough protection for animals in the Bill.
My noble friend’s amendment would mean that the welfare advisory body had to assess the impact on animals where a precision-bred trait was developed, with the aim, as she said, of achieving fast growth, high yields or other increases in productivity. As we have heard, we have seen that too often in traditional breeding methods, so we need to bring in these protections. We have heard many examples of traditional selective breeding producing animals that were highly efficient but this was often at the expense of animal welfare, and we need to ensure that that is not an unfortunate consequence of the Bill. The RSPCA and Compassion in World Farming have raised serious concerns about the lack of safeguards in the Bill to prevent that happening. In addition, the Nuffield Council on Bioethics has drawn our attention to the fact that many of the effects of selective breeding have been unintended.
We agree with our noble friend that it is reasonable that welfare impacts should be assessed here. Without the amendment, it is not clear exactly how that would be part of that process with the advisory body, particularly in relation to other bodies that already exist. So we strongly support my noble friend and believe that her amendments should be in the Bill.
My Lords, I am grateful for another useful debate. I assure the noble Baroness that we sent her a copy of my flow chart, so it must have ended up in her spam folder. I hope none of my other correspondence to her will be rejected into the ether. It sets out in five clear steps the process of taking something through to authorisation.
I say to the noble Lord, Lord Cameron, that I am not one of those people who repel all boarders when it comes to amendments; we have actually moved considerably on the scrutiny of the Bill, and we want to ensure that there is as much agreement as possible. I concede that we might have a problem on Amendment 19, but I will come on to that.
I repeat that the welfare declaration and the welfare advisory body’s assessment will be based on the principle that precision-bred relevant animals will need to be kept in conditions that satisfy existing requirements in the Animal Welfare Act 2006 and, where relevant, the Welfare of Farmed Animals (England) Regulations 2007. So existing animal welfare legislation is in place, and the Bill is intended to work alongside it to enable responsible innovation.
An accusation was made, although I cannot remember who by, that this was an enabling Bill and was somehow a forest of Henry VIII clauses. I reject that. It is not a skeleton Bill. We have set out our substantive policy proposals in the Bill and have included appropriate delegated powers to supplement those provisions. Delegated powers serve a valuable purpose and it is always important to assess them in context. Simply counting up the number of powers in a given Bill is not necessarily always meaningful, but I hope we have shifted the balance in terms of those that are affirmative and those that are negative.
There has been talk of belt and braces. I think you can overdo caution in these circumstances, and you can clog up the system. I really feel it would be difficult to accept Amendment 19 as it would pre-empt the Scottish royal college research project. The Bill already outlines a regulatory framework to safeguard animal welfare that goes beyond existing requirements in traditional breeding.
I hope that my words, and the government amendments to increase the degree of parliamentary scrutiny on the animal welfare provisions in the Bill, provide noble Lords with sufficient reassurance not to press their amendments.
Amendment 17 agreed.
18: Clause 11, page 8, line 25, leave out “this section” and insert “subsection (9)”
Member's explanatory statement
This amendment is consequential on the Minister’s previous amendment to Clause 11.
Amendment 18 agreed.
Clause 12: Report by welfare advisory body
Amendments 19 and 20 not moved.
21: After Clause 12, insert the following new Clause—
“Additional factors to be considered in relation to a precision bred animal marketing authorisation(1) When producing a report under section 12, the welfare advisory body may choose to consider the factors listed in subsection (3).(2) In the event that a report of the welfare advisory body does not consider the factors listed in subsection (3), the Secretary of State must do so prior to making a decision under section 13(1) regarding the issuing of a precision bred animal marketing authorisation.(3) The additional factors to be considered in relation to a precision bred animal marketing authorisation are—(a) whether the precision bred traits will have a direct or indirect adverse effect on the health or welfare of the relevant animal or its qualifying progeny,(b) whether the relevant animal or its qualifying progeny are likely to experience pain, suffering or lasting harm arising from or connected with precision bred traits that aim to produce increased yields, faster growth or any other increase in productivity, and(c) whether the precision bred traits may facilitate the keeping of the relevant animal or its qualifying progeny in conditions that are likely to have an adverse effect on animal health or welfare.”Member's explanatory statement
This new Clause would introduce a small number of additional animal welfare factors to be considered by the welfare advisory body or Secretary of State prior to the granting of a precision bred animal marketing authorisation.
My Lords, I want to pursue Amendment 21. I thank all noble Lords who have spoken and I have listened very carefully to what the Minister has said. My amendments are fundamental to animal welfare issues and, as a number of noble Lords have said, they already have huge public support externally—not only in this House.
I still feel that we are being asked to take far too much on trust. The Minister said that it is not a skeleton Bill and he tried to reassure us on that. I would say on the animal welfare protections it is skeleton and it is sketchy, for the very good reasons that he has outlined in the past, which is that the Government have not decided what they want to do about animal welfare legislation going forward. So, we are being asked to take a great deal on trust. That is why we feel there need to be some minimum protections built into the Bill.
My Amendment 21 is not comprehensive, and I do not pretend it is, but it is the beginning of some basic protections on animal welfare, which in the absence of any other legislation we feel is absolutely necessary. I am very grateful to the noble Lord, Lord Cameron, and my noble friend Lady Hayman, who both made the correct point that at the moment the notifier is in the driving seat on all this. They are providing the information, and they have considerable vested interests in providing a selective range of information to the animal welfare body. There is not an external role for audit and check on the information they provide. We would not get this with any other regulator. Any other regulator the Government set up would be expected to have a wide-ranging role, not just to accept the information they were given. I think the logic of what we are proposing is common sense and it fundamentally addresses animal welfare legislation. I therefore beg to move.
Clause 14: Precision bred animal marketing authorisations: reporting obligations
22: Leave out Clause 14 and insert the following new Clause—
“Precision bred animal marketing authorisations: reporting obligations(1) Before issuing a precision bred marketing authorisation for the first time, the Secretary of State must establish a monitoring system for the reporting of potential adverse effects on the health or welfare of such animals or their progeny which must enable—(a) the voluntary reporting to the Secretary of State by keepers of animals, animal health and veterinary professionals, or others, of adverse effects,(b) the mandatory reporting to the Secretary of State by the marketing authorisation holder of adverse effects, and(c) relevant information to be available to support future research.(2) Regulations under subsection (1) may—(a) define what is meant by adverse effects on health and welfare,(b) prescribe information to be required from the notifier for reporting adverse effects to the Secretary of State,(c) make provision for requiring the recipient of marketing authorisation to take prescribed steps, in connection with supplying such an animal to another person, to secure that prescribed information about the subsequent health and welfare of that animal or its progeny, is provided by, or can be collected from that other person, and(d) determine the period after marketing authorisation that such reporting of adverse effects on the health and welfare of animals or their progeny of a given precision bred technique is to be required.(3) Regulations under this section are subject to the affirmative procedure.”Member’s explanatory statement
This amendment requires that, before precision bred animals are marketed, there be mechanisms established for reporting possible adverse effects on the animals’ health and welfare or that of their progeny. Regulations shall define adverse effects, details of the information required, and the time period over which it is required for any given precision breeding technique and application.
My Lords, Amendments 22 and 23 are in my name and that of the noble Lord, Lord Trees. My name is at the head, but they are really joint amendments, and we grateful for the support of the noble Baroness, Lady Hayman, on the Labour Front Bench and my noble friend Lady Bakewell of Hardington Mandeville from the Liberal Democrats. The aim of the amendments is to ensure that a very clear monitoring system is set up in advance of when gene-edited animals are marketed. This is to ensure that the lessons can be learned about any adverse, or indeed positive, effects on animal welfare so that, throughout the process, we can make those learnings available to others so that animals can benefit in the future.
The provisions in Clause 14, which we are proposing this amendment as a replacement for, say that the Government “may” do this—but this is a fundamental issue about whether or not we are ensuring that a proper surveillance and monitoring system is in place right from the beginning. We would certainly concede that it is appropriate that the regulations to implement such a provision were in secondary legislation, but that is not what Clause 14 says: it basically says that the principle of undertaking a monitoring system is only a “may”, not a “must”. As was referred to earlier this evening, in comparable legislation—the Human Fertilisation and Embryology Act—the principle of having a surveillance and monitoring system in the Act and the regulations for how to deliver it are in secondary legislation. This seems to be a reasonable position.
The Minister talked on a number of occasions this evening about the research project with a Scottish university on how these regulations might work in practice. If you have the provisions on how they will be delivered in secondary legislation, that seems to be appropriate. But our amendment would put in the Bill a provision that the Government will introduce a surveillance and monitoring system and that the information will be recorded and available to inform decisions in the future to guarantee animal welfare— which is a common theme that we have covered this evening.
I am grateful to the Minister and the Bill team for their meetings with me, the noble Lord, Lord Trees, and others on this matter between Committee and Report. I do not wish to put words into the Minister’s mouth, but I can guess what he will say in response to our amendment, given the email that the noble Lord, Lord Trees, and I received from the Bill team on 13 January. The objections were that what was in the Bill was proportionate and what we were asking for was not a proportionate form of regulation. The exact words were that our amendment
“could be seen as being too burdensome a requirement for industry and would remove our ability to scale back reporting requirements in the future if we have a scientific basis for doing so”.
To be clear, our amendment is about putting in the Bill a requirement that there is scientific monitoring; we are not saying that the regulations need to go in the Bill. But the Bill team basically says that making it effectively something that the Government must do— putting it in the Bill—is too “burdensome” a requirement for industry. That does not seem a proportionate approach to a regulatory process, where you are balancing the rightful requirements of people going into this new industry against public benefit and animal welfare. This gets the scales wrong.
This is compounded when the email goes on to say:
“Introducing a requirement on the face of the bill to require and publish data from clinical outcomes from research would also curtail our flexibility and could lead to issues with commercial sensitivity”.
Again, it is not beyond the wit of man for Governments to produce regulations in secondary legislation that ensure that legitimate issues of commercial sensitivity are handled—but that should not preclude the duty on companies to supply that information so that lessons can be learned for the benefit of both animal welfare and public confidence, which is an issue that I think the noble Lord, Lord Trees, will address in some detail.
So I look forward to what other noble Lords will say and how the Minister will respond to both our amendments. I reserve our position on moving to a vote. But we think that this is a really important way of doing what the Government say they want to do: move ahead with this in a step-by-step way, while ensuring that the evidence is retained from the relevant companies and available to inform future research.
I am grateful for the excellent introduction of the noble Baroness, Lady Parminter, which carries my name and those of two other noble Baronesses. I am also very grateful to the Minister for our meetings. As he and others in the House will be aware, I strongly support the Bill, and I commend the Government on including animals in it. Alongside existing animal welfare legislation, the new breeding technologies promise great benefits to animal health and welfare by reducing the burden of disease, thereby maintaining food production with potentially fewer animals, and reducing land use, the use of drugs and chemicals, the carbon dioxide footprint and greenhouse gas emissions.
I will expand on the productivity issue. Productivity goes both ways: you improve productivity by producing the same amount from fewer animals. Reducing the disease burden will enable us to produce the same amount with fewer animals, with concomitant advantages.
I thank the Minister for the amendments he introduced earlier. Although I have great enthusiasm for the modern technologies and for this Bill, which will facilitate the uptake of those technologies, this enthusiasm—and I note that in Committee the noble Baroness, Lady Hayman, referred to mine as “gung-ho”, which I take as a compliment—is not shared by everyone. If we want these technologies to be applied and the benefits to be realised, it is going to be essential to take the public with us and ensure public confidence so that they take them up and accept them. This amendment, as the noble Baroness, Lady Parminter, has elegantly said, basically makes it mandatory in the Bill that there shall be a reporting process for potential adverse effects post marketing. So it differs in that respect from Clause 14, but much of the rest of our amendment is copied from Clause 14.
What we are suggesting is also a two-tier reporting system. The first tier is a voluntary system, proposed for individuals such as farmers, keepers of animals, veterinary surgeons and animal health professionals. But for the commercial bodies that hold a marketing authorisation, there should be a mandatory requirement to collect data about the possible adverse effects on PB animals’ health and welfare and to submit that data at periodic intervals.
I will make a number of key points on the amendments. First, they mirror precisely current regulations with regard to possible adverse effects of drugs marketed for veterinary use, and indeed for human use, both of which have voluntary as well as mandatory reporting systems in place.
Secondly, we submit—and I reinforce the points the noble Baroness, Lady Parminter, made—that we do not feel that what we are asking is disproportionate, in that only the commercial sellers of these animals, the people making money, have the legal obligation to collect adverse effects reports and notify of them. But there is a provision for others to do so voluntarily, which could be a sort of check that the notifiers are not ignoring potential problems.
Thirdly, surely it is in the interests of the developers of a new product to safeguard the reputation of that product by seeking and surveying and monitoring the possible outcomes of the development when used in the real world.
Fourthly, the definition of an adverse effect can be made in regulations, and indeed that is already provided for in Clause 25. But I suggest it should refer to issues over and above the expected health issues that might affect any conventionally bred animals but might reasonably be associated with a particular breeding technology. But this requirement can be time-limited under regulation for any given precision-breeding method.
Fifthly, this can be quite a light-touch system. For example, the reporting of adverse effects of veterinary medicines requires an online pro forma which can be sent in digitally to the Veterinary Medicines Directorate, which assesses it. That directorate, of course, already exists. The marketing authorisation holders could also submit their reports in the first place to something like the VMD, which could triage them and then pass them to the Secretary of State for consideration by the animal welfare advisory body, which is already set up —we are not asking for new bodies to be set up.
Sixthly, and perhaps most importantly, the public acceptance of precision-bred animals is hugely important if the Bill is ultimately to be of value, and I submit that it will be a considerable reassurance for the public to know that the sale and commercial breeding of precision-bred animals will be monitored for unforeseen negative effects post-marketing to complement the pre-marketing reporting requirements under Clause 12.
Seventhly, such post-marketing monitoring will also provide both the animal welfare advisory body and the marketeers with essential feedback on the robustness, validity and safety of their pre-marketing assessments. That would be important to inform them and help them develop, if necessary, better systems.
Eighthly and finally, the Minister has assured us that the use in animals will be phased in. Surely, if one is phasing in, one would want to monitor what was happening to the first group in the real world when it is being sold and used by farmers. Only then, by collecting that information, could you be assured, at the end of whatever length of time that phase is, that it is safe and appropriate to proceed to subsequent phases. I would argue that phasing in automatically suggests that one needs to be monitoring what is happening in that first phase, which will involve thousands of animals but will be a real-world experiment to prove or disprove the safety of the system. I do not expect there to be major problems, but it will give assurance to the public. On these collective grounds, I support Amendments 22 and 23.
My Lords, I thank the noble Baroness, Lady Parminter, for her thorough introduction to her two amendments, to which I am very pleased to have added my name. We strongly support what she is trying to achieve. We believe that there does need to be a reporting process for the adverse effects on the health and welfare of animals and, of course, their progeny. The noble Baroness, Lady Parminter, talked about the importance of evidence being retained to inform future research, as did the noble Lord, Lord Trees. This is also about public benefit; we discussed public benefit a lot in Committee, and it does need to be central to the Bill.
As the noble Baroness also said, we need to understand any lessons that can be learned. The noble Lord, Lord Trees, put it very clearly and succinctly when he talked about “robust” feedback. When we look at the first tranche of animals, we need to have the confidence that the industry is acting appropriately, that the outcomes are what we would hope to see and that we can catch anything that perhaps is not what we hoped for.
The noble Lord, Lord Trees, talked, importantly, about public confidence, as did the noble Baroness, Lady Parminter. If we are to carry the public with us, the future monitoring of animal health and welfare, consequences and outcomes is really important. Understanding adverse events is therefore terribly important. The noble Lord talked about drug introductions in the veterinary field, and we should have the same principles here, I believe, if we are to carry the public with us.
It does not seem to me that this amendment is disproportionate in any way. Instead, it would bring in some really important checks and balances and underpin what the Government are trying to achieve. I urge the Minister to consider very carefully what noble Lords have said. If the noble Baroness wishes to test the opinion of the House, she will have our support.
My Lords, I repeat, again, that I am a very strong supporter of this Bill and everything it stands for. However, again, as I have said at every stage and indeed a moment ago on the previous grouping, the one weakness of the Bill is around animal welfare. Anyone reading the Hansard of the passage of this Bill through the Commons will note that it was the greatest concern of MPs too, but they failed to make even a dent in the Government’s protective carapace on this issue.
In Committee, many noble Lords from all sides of the House—myself included—put down amendments to try to minimise the possibility of any genetic change being proposed or implemented that could result in the future suffering or discomfort of, or distress to, animals or their progeny involved in the process. However, none of these amendments was put to the vote. We now have a well-thought-out amendment—or two—which precisely covers the worries that we all had and attempts to avoid them. The Government should think seriously before they reject them.
I thank noble Lords for their engagement on this important issue. I am grateful for the meetings that I have had with noble Lords from across the House on this and for them taking the time to share their thoughts with me and with the House on this occasion. I have found it constructive and enlightening.
We recognise that there is a need to safeguard animal welfare in the new regulatory regime; we are all united on this. That is why we are taking a step-by-step approach with regulatory changes for plants first, followed by animals. The measures in this Bill in relation to precision-bred animals will come into force, as I said before, only when safeguards for animal welfare are in place. This will include a monitoring and reporting system for the precision-bred animals once they are placed on the market.
The Bill will give us the ability to place a time-limited and proportionate duty on breeders and developers to monitor for significant health and welfare outcomes in animals that could be linked to their new traits and to report such outcomes to Defra. This monitoring and reporting system will be informed by research that we intend to carry out—which I have already spoken about—to help us identify the specific outcomes that must be reported, as well as appropriate timeframes and numbers of generations that must be monitored for each species or type of animal.
We believe that the powers in the Bill are sufficient to enable us to put this monitoring system in place. Clause 14 sets out that regulations may require the notifier, or any other person specified, to provide information to the Secretary of State about the welfare of the relevant animal and its qualifying progeny. The regulations may set requirements on the information that must be collected, and they allow the Secretary of State to apply reporting requirements in a bespoke manner. This flexibility is essential to ensure that any obligations placed on businesses are proportionate to risk—this is the key point that I hope I may be successful in getting across.
For example, proposed subsection (1)(c) of the alternative clause proposed by the noble Baroness, Lady Parminter, and the noble Lord, Lord Trees, would require the Secretary of State to mandate developers to share additional information for the benefit of other developers and researchers. It may be difficult to reconcile these requirements with the right of businesses to keep commercially sensitive information out of the public domain. I understand that there is a difference of opinion here, but I am led to believe, by people who understand the legal parameters within which we operate, that this really is important.
Clause 18 already provides adequate powers to share relevant information about marketing authorisations as required, while making sure that sensitive information is suitably protected. These powers will work alongside the powers under Clause 15, which enable the Secretary of State to make regulations setting out the circumstances in which an animal marketing authorisation should be suspended or revoked, such as on health and welfare grounds.
I turn now to Amendment 23, for which I thank the noble Baronesses, Lady Parminter, Lady Hayman of Ullock and Lady Bakewell of Hardington Mandeville, and the noble Lord, Lord Trees. This amendment would allow regulations under Clause 18 to require records of clinical outcomes, and any adverse effects and outcomes, of precision-bred animals and their qualifying progeny to be published on the register of precision-bred organisms. I think that this is there in the Bill—Clause 18(1)(j) already allows for regulations to prescribe additional matters relating to this Act to be included on the register.
I just reiterate that, before applying for a precision-bred animal marketing authorisation, the notifier will need to carry out an assessment of whether the health and welfare of a precision-bred vertebrate animal and its qualifying progeny are expected to be adversely affected by any trait resulting from a feature of the animal’s genome that results from precision breeding. This part of the application is not intended to be a tick-box exercise but, rather, a substantive assessment of risks to animal health and welfare that may result from the precision-bred trait. It will require a substantive assessment backed by a submission of data to show how a range of relevant criteria have been assessed.
I hope that, in the light of these points, I can persuade the noble Baroness and the noble Lord to consider not pressing their amendments.
I thank the Minister for that reply. Sadly, it is quite clear, in the almost immortal words of the noble Lord, Lord Cameron, this evening, that we have not yet managed to make a dent in the Government’s protective carapace on this Bill—it is a great phrase—which is a disappointment, as a number of other amendments earlier in the evening led up to this amendment.
I do not want to spend much time. I just want to make two points to the Minister. He did not answer the fundamental question that Clause 14 says only that regulations “may” make provision. There is absolutely nothing to stop a future Government—and I do not wish to impugn the Minister’s character or motives—not doing anything at all. It is not about the regulations in future; they do not need to introduce a surveillance monitoring system in the future because all that is in the Bill is that regulations “may” make provision. If it was regulations “must” make provision, that might have made a difference, but the Minster was not prepared to concede that.
Secondly, we have a difference of opinion on the issue of commercial sensitivity. I referred to other legislation in comparable fields of human research where this issue has been overcome, and the noble Lord, Lord Trees, outlined other legislation in the veterinary field where this commercial sensitivity issue has been addressed with wording in legislation to that effect.
So I am not content with what the Minister has said. I have seen where we have been heading this evening, but I think it is a matter of principle. For those of us who feel strongly about this, this was a solid amendment seeking to do a good job to help this Bill from both sides of the House, and I wish to press it to a vote.
Clause 18: Precision breeding register
Amendment 23 not moved.
Amendments 24 and 25
24: Clause 18, page 13, line 16, at end insert—
“(6A) Regulations under subsection (1) are subject to the affirmative procedure.”Member’s explanatory statement
This amendment would provide for regulations under Clause 18(1) to be subject to the affirmative procedure.
25: Clause 18, page 13, line 17, leave out “this section” and insert “subsection (6)”
Member’s explanatory statement
This amendment is consequential on the Minister’s previous amendment to Clause 18.
Amendments 24 and 25 agreed.
Clause 22: Advisory bodies
26: Clause 22, page 15, line 27, leave out “negative” and insert “affirmative”
Member’s explanatory statement
This amendment would provide for regulations under Clause 22(3) to be subject to the affirmative procedure.
Amendment 26 agreed.
Amendment 27 not moved.
Clause 48: Short title and commencement
28: Clause 48, page 30, line 22, leave out subsections (2) to (5) and insert—
“(2) This section comes into force on the day on which this Act is passed.(3) The rest of this Act comes into force on such day as regulations may appoint.(4) Regulations under this section may not be made until the Secretary of State has laid a Priority Setting Partnership Report before both Houses of Parliament.(5) The Priority Setting Partnership Report shall be drafted by a Priority Setting Partnership established and funded by the Secretary of State, and include a response from the Secretary of State.(6) The Priority Setting Partnership shall—(a) identify evidence uncertainties in relation to precision breeding which cannot be answered by existing research,(b) produce a list of research priorities in relation to precision breeding, and(c) make comments on this Act in relation to issues identified in respect of paragraphs (a) and (b).(7) The Priority Setting Partnership shall have a membership comprising—(a) scientists and academics with expertise in the field of genetics, agriculture, and ecology,(b) lay members of the public,(c) representatives of animal welfare organisations, and(d) other interested parties.”Member’s explanatory statement
This amendment would require a report to be published identifying gaps in scientific evidence relating to precision breeding before the Act can come into force.
My Lords, I am aware of the time but I have attempted, through this amendment, to find a creative new way of tackling some of the issues that have come up in the Bill. The noble Baroness, Lady McIntosh, said quite some time ago, early on, that we have to reassure the public. The noble Lord, Lord Trees, said in the last debate that it is essential to take the public with us. The Minister said that it is essential to build confidence. This amendment seeks a positive way forward. For anyone still worrying about their dinner break, I am not intending to put this to a vote, for the avoidance of doubt, but I want to suggest a way forward for what has clearly been a very difficult Bill with a lot of issues that remain of great concern in your Lordships’ House and more broadly.
On the first group, I spoke about the number of people whom I know are watching the debate at this very moment and feeling very disappointed about what has happened—or rather, not happened. I also refer back to what I said at the start about the scientists who were coming to me saying, “How do we get our knowledge through to the Government? We feel we are just not being heard”, and these are experts in a range of different fields. This is a creative suggestion. I might have included the word “consultation” but, as we have heard in debates on various amendments today, the Government did consult the public and stakeholders and then entirely ignored what they said. It might be said with some justice that what result you will get depends on how you ask the question. Indeed, I think the Minister at some stage referred to a survey saying, “If we can get drought-proof wheat with gene editing, should we go ahead with it?” If you phrase the question that way, you will get a positive result; however, that is not listening to the academic—a proponent of the technology—who said to me this week, “You cannot drought-proof wheat with one genetic change. That is a fact.”
What I am suggesting here is a process of deliberative democracy. This is something that has really taken hold in government departments—not, that I know of, in Defra, but in others—and indeed across the world. Some of the classic examples of deliberative democracy are in Ireland, on equal marriage and on abortion, where the public, when allowed a chance to deliberate and carefully consider the issues, showed themselves to be significantly in front of the politicians. We have seen climate assemblies in the UK— that may have been under Defra; I am not sure what department they were under. We have seen a very effective climate assembly in France. Lots of local government organisations have been having climate assemblies. It is a way of getting people together and getting themselves informed, both the general public and stakeholders.
I borrowed the term “priority setting partnerships” from an organisation called the James Lind Alliance; I did not ask first. I have spoken to people who have been involved in this process, and it is of particular relevance here because it has been used in a significant number of cases to look at how to set priorities and make decisions about ways forward in healthcare. It brings together clinicians, patients and carers in those healthcare settings. My Amendment 28 is a commencement amendment, but I am not going to push it on that basis. My constructive suggestion to the Minister is that, to find a way forward among many of the issues that have really not been resolved in your Lordships’ House, and have not been resolved among scientists, the Government should seek a deliberative process looking at how the regulations are constructed for the Bill. That process could actually get public involvement and engagement, because I guarantee him that there will be a great deal of public concern and public anger about where we have got to today, and public resistance to the products.
That issue is particularly going to arise around whether gene-edited products will be labelled. I could very easily have tabled amendments on this; lots of people asked me to. We debated it extensively in Committee, but I could not see a different way forward and I did not simply want to revisit the Committee debate. However, if we are going to talk to the public about labelling and about what is happening to their food, we know how deep the public’s concern is about food safety, the nature of their food and the way it is produced. I do not need to list all the scandals and the concerns, including genuine health concerns, that have arisen in recent years. This is an area of public concern, so I am suggesting that on regulations, issues such as labelling and many of the things that remain unresolved, the Government should bring together scientists, government officials, experts and the public and seek a way forward that works.
While I remain gravely concerned, for all the reasons I have set out previously about the Bill and what it could unleash, I think there is a very significant chance that this will go nowhere, both because of the legal tangles and the public resistance. If the Government want to find a constructive way forward, I have set out here a way in which they could co-create a model with the public and the experts. That is my genuinely constructive suggestion, and I beg to move.
My Lords, if Amendment 28 is agreed to, I cannot call Amendments 29 and 30 for reasons of pre-emption.
My Lords, I rise to speak briefly to Amendment 28 in the name of the noble Baroness, Lady Bennett of Manor Castle, who has spoken at length on why she feels it is necessary to delay the implementation of the Bill. The Bill sets in train a considerable step towards precision engineering and a move away from traditional practices. Great care is needed to ensure that all unintended consequences are avoided. The extra protections that the noble Baroness proposes are therefore necessary and I look forward to the Minister’s response and reassurance on this matter.
My Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for her thorough introduction to her amendment. I completely understand why she is bringing it forward. There are areas of the Bill around implementation, oversight and the step-by-step process that we have discussed time and time again that people are still concerned about. The requirement of the amendment for a report to be published that identifies any gaps in scientific evidence is an interesting one. It will be good to hear the Minister’s thoughts on this.
My Lords, I thank the noble Baroness, Lady Bennett, for this amendment. I am keen to have a much wider conversation with people. My learning curve has been incredibly steep as I have gone through this—the noble Baroness, Lady Hayman, is nodding as well. It is an area of science which is not understood by an awful lot of people. While I have sought to bring in as many safeguards as possible, there is a continuing job to do for all sorts of parties, not just the Government, to explain the benefits of this technology and the safeguards that the Government are introducing. However, I do not think that a priority setting partnership should be established in or under this Bill.
The Bill places science at its core. ACRE advised that precision-bred organisms pose no greater risk than traditionally-bred counterparts. As I said earlier, its advice is supported by the Royal Society, the Royal Society of Biology, the Roslin Institute and a wealth of peer-reviewed literature. The Royal Society stated that
“these are no more likely to pose a risk to human health or the environment than non-editing derived mutations, which occur spontaneously in each new generation”.
In earlier debates, I have sought to make it clear that if we inserted regulatory measures or language into the Bill that somehow elevated this technology beyond where it is, we risk misleading the public and we have to be really careful about that.
ACRE’s expertise in precision-breeding technologies is considerable, having first advised on them in 2013. We used this as a basis for our intervention in a pivotal European Court of Justice case in 2018 and for our consultation on genetic technologies in 2021.
The Secretary of State will be required to make decisions based on the advice of expert committees. As part of its current role as adviser on genetically modified organisms, ACRE will also advise the Secretary of State on whether an organism is precision bred. A comprehensive understanding of the underlying science is essential for this process and ACRE members have a wealth of experience in the regulation of genetic technologies. Moreover, this Bill will sit alongside existing legislation that deals with human, animal, and environmental health.
I understand the noble Baroness’s reservations. However, where we have identified evidence is incomplete, we have taken steps to address this. The regulations under the Bill will not come forward until the relevant measures are in place, and Parliament will have the opportunity to further scrutinise them.
As I have already mentioned, we have commissioned Scotland’s Rural College to gather the evidence required to develop the health and welfare assessment underpinning the animal welfare declaration. The research will involve experts from the Animal Welfare Committee and a wide range of organisations with expertise in animal welfare, genetics and industry practice.
The Advisory Committee on Novel Foods and Processes is providing advice to the Food Standards Agency for the development of a regulatory framework to provide assurances on consumer safety for precision-bred organisms to be used for food and feed. The committee has a long history of providing independent scientific advice to the Food Standards Agency on matters relating to the safety of food products, including GMOs and precision-bred organisms. Furthermore, we have been continuously engaging with national and international stakeholders and regulators to develop the best regulatory regime for precision-bred organisms.
Noble Lords can be certain that Defra will ensure that the provisions of this Bill are effective and reflect scientific progress. We will continue to be aligned with the wider governmental priorities, making farming greener and more productive while helping to grow the economy, create jobs and improve food security. I give the noble Baroness the assurance that I will be open to any suggestions that will provide a forum or fora for a wider conversation with the public. It is the job of agencies of government, such as the FSA, to continue in a vital social science role to inform people about the quality of the food they eat, where it comes from, and what is involved in its production.
I thank the noble Baroness for her detailed consideration of this topic, but I hope I have convinced her that this amendment is not needed. I hope that she is reassured and is able to withdraw it.
I thank the Minister for his answer. I will certainly look to take up his offer in the final section of his response. I also thank the noble Baronesses, Lady Bakewell of Hardington Mandeville and Lady Hayman of Ullock, for acknowledging the reasons why I brought forward the amendment and the continuing issues around the Bill, that, I think, the Minister also acknowledged to some degree.
I make one comment on the Minister’s reliance on ACRE, which has an extremely narrow scientific focus that lacks the sociological and ecological approaches that would give the Government a much broader view. The noble Lord, Lord Krebs, and I were playing with metaphors around centres of gravity and shifting balance. ACRE reflects one part of the scientific community and views, but not perhaps the more, dare I say, modern and newer forms of biology, which are not represented in its membership.
However, we are where we are, and I feel the next debates pressing in on us. We have had a good debate today. I do not think we have got to where we need to go, but I do not think we are finished on this issue by any means. In the meantime, I beg leave to withdraw my amendment.
Amendment 28 withdrawn.
Amendments 29 and 30 not moved.