Genetic Technology (Precision Breeding) Bill Debate
Full Debate: Read Full DebateLord Krebs
Main Page: Lord Krebs (Crossbench - Life peer)Department Debates - View all Lord Krebs's debates with the Department for Environment, Food and Rural Affairs
(1 year, 11 months ago)
Lords ChamberMy 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.
I have nearly finished my remarks. I have some sympathy with the amendments from the Front Bench opposite and would like to hear a very good reason why my noble friend may be minded not to support them.
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.
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.