Genetic Technology (Precision Breeding) Bill (First sitting)

Daniel Zeichner Excerpts

Committee stage
Tuesday 28th June 2022 Public Bill Committees

[Daniel Zeichner (Cambridge) (Lab)]

Q Good morning, everyone, and welcome to our witnesses. I would like to go straight into a real-world example. One example cited of a possible real benefit is in the sugar beet sector. I come from the east of England; I am sure you are familiar with the issues in that region about neonicotinoids, virus yellows and so on. Could you talk us through the potential there, but also comment on the issues that might arise in trade terms if our friends, our European partners, take a different view and what the risks might be?

David Exwood: Virus yellows in beet is something carried by aphids into the sugar beet crop in the spring and it can have a dramatic effect on yield. We saw two years ago reductions of up to 80% in the beet yield in affected fields. So that is a real-life example of a pest that can dramatically affect the productivity of a crop. We produce about 1 million tonnes of sugar beet in this country each year, and that can be dramatically reduced through virus yellows.

Through precision breeding, we have the ability to breed in genes resistant to virus yellows so that the plant just will not be impacted and all the issues of neonicotinoids and using synthetic insecticides to try to control the aphids and control the impact of virus yellows will disappear. That is a real gain in an industry that clearly needs support and could be really impacted. That is the really clear gain and potential of this technology that the Bill will allow. And there is the point about the sustainability of that business. It is such a concentrated business in a certain area of the country.

To move on to the trade environment, this technology absolutely has to be one that is used widely. I am really clear that the EU is moving on gene editing and precision breeding; it is very clear about that. Actually, my greatest worry is that the UK gets left behind on this technology. The rest of the world is moving, and we need to move with it. We absolutely live, work and trade in a European environment and a world environment, but, given that the EU is moving, my concern is more that we get left behind, rather than us moving ahead of them and nobody coming with us.

Dr Ferrier: Obviously, it is very difficult to predict, but the indications from companies are that, should this legislative change happen, it would be at least five years before products start come on to the market for farmers and growers to use. Clearly, the international trade impacts will depend on the harmonisation across trading partners in terms of the legislation in their jurisdictions. I believe that within the period necessary for those products to come on stream commercially, there will be much more harmonisation. As David said, that will also happen in the EU, which plans a legislative proposal by quarter 2 of 2023. We are not concerned about imminent trade issues, because no products are available for us to use at the moment.

[The Chair]

Thank you. I call the SNP spokesperson, Deidre Brock.

--- Later in debate ---

[Jo Churchill]

Q Good morning, Professor Henderson. Are you content that this Bill is based on the best available science? Would you like to explain the input you have had into the Bill?

Professor Henderson: Yes, I would. I think I can reassure the Committee on both those questions. I have been involved since the very early stages of the preparation of this Bill in consulting widely with the scientific community, advising Ministers and officials in my Department and others, and talking to stakeholder groups about the science and its implications. The Bill has taken into account the science and the most expert views of it in a very diverse way. I am personally content that it is fit for purpose and will ensure the continued safety of the environment and food.

[Daniel Zeichner]

Q Good morning, professor. It is very good to see you. You will appreciate that one of the big discussions about this Bill is likely to be about definitions. I want to go into some of them, because you will be aware that some of the learned societies—the Royal Society of Biology, for instance—have questioned the very existence of the concept of a precision bred organism. Can a precision bred organism contain exogenous genetic material? If so, can you explain how that is different from a genetically modified organism?

Professor Henderson: There is an interesting question about how far deregulation into genetic technologies ought to go in one step. Some groups of scientists would certainly favour a model in which you relax the regulation much more widely and base all the outcomes on the traits that are produced through that technology—the outcome in the product—rather than having any view about the technology or the process by which the product is made. That is certainly a view that some scientists would hold.

The view of Government—this has played out in a number of stakeholder groups— has been that moving more cautiously to deregulate or lower the regulation of some aspects of genetic technologies first is a cautious and stepwise way to move. That takes account of the science, enables us to be aware of the issues as they arise, and most importantly builds the confidence of the public as those technologies are used more widely in food production. That is the justification for moving first into the use of technologies only to mimic breeding processes through precision breeding, as described in the Bill.

There is a difficulty in describing the limits of what is possible with breeding. It is clear that some things that are possible—we know they are possible because we have done them—are very similar to things that have been done, and they are therefore clearly in scope. There are other examples that are clearly not possible through breeding. In between those, there is something of a grey area. There is now detailed advice from an expert group—the Advisory Committee on Releases to the Environment—that lays out the definition of the circumstances in which something would be considered possible through breeding, and therefore would be considered a precision bred organism, to define the line within that grey area.

You also asked about exogenous material, by which I take it you mean material from another species. That sort of material can occur entirely naturally, and it can occur during breeding processes as well, but in general it does not lead to any functional change or any phenotypic change. The Bill is designed not to allow exogenous material, if it has any functional or phenotypic outcome in the product. In that way, it does mimic the action of traditional breeding. I hope that answers your question.

[Daniel Zeichner]

Q It starts to answer it, yes. I have the technical guidance from ACRE in front of me, which I will pursue with a subsequent witness. Most of us have understood that the Bill has been brought forward in order to preclude the inclusion of exogenous material. However, I think from what you are telling us that the Bill, as drafted, does not do that.

Professor Henderson: The Bill is designed to exclude the intentional inclusion of exogenous material, or the residual accidental inclusion that has any outcome that matters. That is probably the shortest way of summarising it. If there happens to be a bit of exogenous material in there that is similar to what might happen through the natural breeding process, or entirely naturally, but it has no functional outcome—no phenotypic change on the crop or the livestock—that is not considered an issue. Any intentional or accidental change that leads to a phenotypic outcome—the crop being different in a way that could not have been possible through traditional breeding—is not allowed under the terms of the Bill.

[Daniel Zeichner]

Q I think we will probably be coming back to that as we discuss the Bill line by line. Finally, what is your definition of the difference between what you have just described and a GMO?

Professor Henderson: GMO is a broad church of definition. A thing that is clearly outside of the terms of the Bill is the intentional insertion of a transgene—genes from another species—in order to create the effect that you wanted. That would be in order to make the product different in some way by bringing in an—[Inaudible.]

[Daniel Zeichner]

Q It is beginning to sound to me like the difference will come down to whether it is intentional or unintentional.

Professor Henderson: It is to do with intentionality, but it is also to do with the outcome—[Inaudible.]

[Daniel Zeichner]

We are losing you, but I get the drift. I will leave it there.

[The Chair]

Professor Henderson, I do not know if you can hear me, but you are frozen on our screen.

--- Later in debate ---

[Jo Churchill]

Q Good morning, Professor May. I will start with a broad question. Why is it necessary to create a new regulatory framework for precision bred food and feed products, and how will the FSA balance safety in doing so?

Professor May: There are probably two answers to why this is necessary. Currently, precision bred foods and feeds will be encapsulated within the existing GM framework. If they are moving out of that framework, it is important to be sure that those products are safe. The key difference here with traditional breeding is one of pace. The entire point of this technology is to do things that could have been achieved through traditional breeding, but much faster. It is important that we have safety checks along that pathway.

On your question about balance, I think the key balance to strike here is between supporting innovation and ensuring safety. At the moment, our thinking around this is to have a two-streamed process for regulation, where there is a very light-touch process for anything where there is unlikely to be a substantive change in the food and more scrutiny of anything where the final food product is different. I think that is quite appropriate for this blend of technology.

[Daniel Zeichner]

Q Good morning and welcome. You may have heard some of the previous discussion around labelling. Indeed, it is something the Food Standards Agency has looked into. Could you tell us what work the Food Standards Agency has done on assessing the public view on labelling and what conclusions you have come to?

Professor May: We have undertaken quite a lot of consumer research in this area, as have many others. There are various take-home messages from that. The first is that there has been a perceptible shift in public views over the last 10 or 20 years, and there has been more interest in the potential benefits of this technology. That is mirrored by a really strong view that the public want some level of regulation and safeguards in this and other genetic technologies.

Specifically around labelling, there is a very strong majority of the public that we have polled, and that others have seen, who would like labelling of these products. There is some difference of views about what that labelling should entail, but there is a strong feeling around it. From an FSA perspective, we would in principle support that, because we stand very strongly for transparency. The problem, sitting here as a scientist, is that this is not really achievable for this particular group of foods, because the entire nature of the precision breeding legislation is to consider things that could have been produced traditionally.

Consequently, you may end up in the future with two apples, for instance, and one was produced by precision breeding that involves gene editing and the other was produced by traditional methods. It would be scientifically impossible—at least, at the moment—to tell those two apart.

Then, from my perspective, my view is that a label that is not enforceable and that might be misleading is actually worse than no label at all, because you then start to spread doubt about the validity of other labels in the food system: allergen labels, nutritional labels. While in principle I think labelling would be a good thing, the fact that we cannot enforce it makes me feel that this is not appropriate for this type of food.

[Daniel Zeichner]

Q Could you say a little bit more about distinctions between the new nutritional labelling and the other labelling? I think that is important for the Committee to understand.

Professor May: Labelling in the UK is quite a complex system. There are different legislative responsibilities in the different devolved Administrations, for instance. Broadly speaking, there are a whole variety of things, as we know, on a food label. The most obvious that most of us look at are things such as calories, fat content and salt content. There are very tight legal guidelines around what must be present on the label and that it must be accurate. Clearly, if you say that it contains 6 grams of salt and it contains 7 grams, that is not legal.

That holds also for other aspects. There are safety aspects of labelling, such as allergen information, which is critical for many of us, and country of origin. Then there are a raft of labels that may not have a legal framework, but which have recognition under guidelines—Red Tractor and animal welfare standards, those kinds of things. There is quite a lot on the label already. Under the current legislation, any food that is approved as a genetically modified food is labelled as such.

[Daniel Zeichner]

Q May I press you on one final example that has been brought to my attention? It is one of a tomato that could be genetically edited to boost vitamin D content, for instance, and then the cases where some people sadly have an issue with vitamin D. Is there a danger that we could end up not alerting those people to those problems if we do not label properly?

Professor May: That is a good example of somewhere where I think we would have a different approach. Just to go back on the approach we are currently proposing—I stress that there is nothing set in stone yet. This is an approach that we are working quite closely on with our advisory committee on novel foods and processes to develop firm guidelines. At the moment, our thinking is around this two-tier process. Tier 1, for instance, would be foods where there is no compositional change in the thing you eat. A strawberry with a different root system, but the strawberry itself is identical, would not need substantial regulation. In contrast, with the vitamin D tomato that you mentioned, the thing you eat is now different; there is vitamin D in there. Those would be risk assessed and under that risk assessment the key issue there would be one of safety.

In an example such as that one, where there may be a subset of the population for whom this is dangerous, absolutely, we would incorporate that into the risk assessment and our guidance to Ministers then would be that it would be entirely right and appropriate to label that food, possibly with a label that says, “Not suitable for certain groups.” You could imagine a scenario where a food is not suitable for pregnant women, for example, and we would certainly stand strong on the fact that the bottom line is that the food needs to be as safe as it is today. Anything that might compromise safety should clearly be labelled as such.

[Daniel Zeichner]

Q All that is very interesting and very good, but I do not actually see that this is covered in the Bill as it stands. This is all going to have to follow through secondary legislation, is it not?

Professor May: That is correct. At the moment, part 3 of the Bill encompasses the direction of travel, but not the details. That is something we are working on at the moment.

[Deidre Brock]

Q Food Standards Scotland produced a paper in March of this year that pointed out potential for regulatory divergence between the four nations of the UK and that the Bill could result in Ministers in England taking decisions on the approval of genome-edited food and food products with little or no involvement from Food Standards Scotland or, indeed, Ministers in Scotland. It is an independent authority, as you know. Can you tell us how that relationship will be approached and managed, if the Bill becomes an Act?

Professor May: Happily, I am here as a scientist, so I can say that, scientifically, we have an extremely close working relationship with FSS and other regulators around the world, but the closest is with FSS.

If I give an example, at the moment, risk assessments that we might do in FSA are shared very closely with FSS. All that process is done together. Often we are using the same sets of experts—for example, to provide information. Once the risk assessment is done, it passes to a risk management process. I cannot think of an example where there is a difference in the risk assessment part between nations, because the science is the science.

Where there are sometimes differences is in the risk management area. A current example is raw drinking milk, because the science around the risks of drinking such milk is the same, but England and Scotland have different views on how much risk is acceptable. Under this framework, I would fully intend that we would share all the science around the risk assessments of a precision-bred product. Ultimately, though, the decision on a risk management basis and whether to authorise it would fall to Ministers in each of the individual countries.

--- Later in debate ---

[Kate Green]

Q To what extent would it be your responsibility to intervene in the event of misinformation? We are particularly concerned now about online misinformation.

Professor May: That depends very much on the type of misinformation. Local authorities usually enforce in that area. When a product is not what it says it is, for instance, it gets seized or withdrawn from retailers at local authority level. We issue alerts, and we have a national food crime unit that is very actively involved in looking at deliberate crime in the food sector, including people selling things that should not be sold or that are misrepresented. We also do quite a lot in the detection and enforcement of large-scale issues, including supply chain problems, incorrect labelling and so on.

In the case of precision breeding, it will clearly depend on what Parliament decides, but if there were a regulation on labelling, we would need to look carefully at how that responsibility goes out to the different regulators. We would undoubtedly have a view, and we would issue information for local authorities to enforce on what should and should not be on a label.

[Daniel Zeichner]

Q I have two sets of questions. First, I want to go back to labelling, because I have been mulling over your response. Is the objection to labelling the two apples that you cannot, at the moment, have a test to tell them apart? Is that, in principle, the reason for not labelling, or is there another reason?

Professor May: That is exactly right. As the legislation stands, you might introduce what is called a single base pair chain—a tiny, one letter change in the DNA code of that apple. Those single letter changes happen all the time. If you have a field of apple trees, they will all be slightly different, even if you cloned them all initially, so we would not be able to take that apple, sequence the DNA and definitively say, “This one was created by someone using genome editing, and this one just turned up by chance in the field.” As you cannot tell those two apples apart, if there were a label on one saying “Precision bred” and a label on the other saying “Not precision bred”, I could not, as a scientist, say that that was true. That therefore raises questions in my head about why you would have a label if you cannot be sure, in the first place, that what it says is true.

[Daniel Zeichner]

Q I get that, but if there were a genetic marker that you could identify, would that give you a mechanism for doing that?

Professor May: In principle. There are ways that you might do that. One way that some developers are thinking of—in the context of protecting their intellectual property—is to make that single letter change in a background of lots and lots of other single letter changes that you already know, as a kind of barcode. Then, the concept would be to mount a defence, so that if someone steals my apple, I would be able to say, “But this apple that you are selling has that single letter change, and the other 15, all of which were in my original stock apple, so this is my apple, not yours.”

That is a reasonably good way of protecting intellectual property if you are trying to claim that something is yours. It is very difficult to use that the other way around and say, “That is definitely precision bred.” I could be growing my apples and say that those 15 changes occurred spontaneously. Again, it is not currently possible to say definitively that they cannot have appeared naturally.

[Daniel Zeichner]

Q Thank you, that is helpful. My second question is about the register established by the Bill, which the Food Standards Agency is required to maintain. The Bill is fairly light on explanation as to the purpose of the register. Could you explain what you think its purpose is and who is likely to use it?

Professor May: The idea behind the register is to have a public awareness of the products that are going through this pathway and are ultimately out on the market, in a similar way to the public registration of foods at the moment. To take a current example, if you applied to us with a novel food, you would apply with a dossier of data that says, “This is the food. This is how I produced it. Here is how I have considered safety risks.” At the point that we say the dossier is complete and sufficient for us to consider, we publish and say, “This company has put its proposal in. We are now considering that product.” In the fullness of time, we will either recommend approval or not for that product. If we recommend approval, that will get registered publicly as well, so people can see what this novel food is and where it came from, and be reassured that there has been a due process behind it.

My view as a scientist is that this should be the same for precision breeding. We should have a register that says, “Here is a product that has been considered. We have looked at it; it hasn’t rocked up without any kind of due diligence around it.” It is there in the public domain for people to see what process it has gone through and be reassured that those products have had some level of scrutiny.

[Daniel Zeichner]

Q I am slightly sceptical here. I imagine one of my constituents going into a garage and buying a chocolate bar that was produced with some genetically edited sugar grown in eastern England. I am not convinced that they would check the public register to find out whether that product had been produced in this kind of way. Is the register really aimed at consumers?

Professor May: It is aimed at some consumers, and that is true now. On average, most of us spend less than six seconds considering each food item we purchase in the supermarket, which is not enough time to consider the label. Some consumers, depending on their concerns, spend more time looking at labels. If you are an allergen sufferer, you spend a lot of time looking for allergens. If you are a vegetarian, you check that the label says it is vegetarian. We know most consumers are a bit uninterested in some of these issues, so they probably will not stop in that garage and check whether the product is on the register or not, but there will be some consumers who have strong views on this, and they may or may not wish to purchase something accordingly. It is important that the information is available for them, so that they can pause if they want to and find out. Even if most people do not, it is available, should they wish to do so.

[Daniel Zeichner]

Q But that is the difference between having it on a label and on a register, isn’t it? A register requires a bigger effort to check, frankly.

Professor May: There is a slight threshold—yes, that is true. That is not unique to precision breeding. People are quite rightly demanding more and more information about their food. The labels are not getting any bigger, and certainly my eyesight is getting worse, so there is already a shift, and we see that. Many of us are doing more and more of our purchasing online. We actually never look at the sticky label on the food item because it is on a webpage instead. People are getting more used to looking elsewhere for information, so it is not the hurdle it used to be. You are quite right: there is a limit on how much we can fit on a physical label, and it is jostling for space with allergen, nutritional and the country of origin information, so there is limited real estate on the back of the label to get this information across.

[Daniel Zeichner]

Q But as far as you understand it, the purpose of the register is to give that public reassurance. It is a public information issue.

Professor May: That is correct, yes.

[Jo Churchill]

Q What learnings have you taken from looking at countries that already have taken this technology forward? I am thinking in particular of Canada, Japan and Argentina—places where we holiday and are very comfortable with eating foods there. What have we learned from looking at other countries across the world, and how have you referenced that learning in the proposal you have put forward?

Professor May: There is a range of approaches across the world. It is probably true to say that no two countries have exactly the same approach at the moment. Perhaps I may give some examples.

At one end of the scale, you would have the current approach in the European Union, where all genetic modification, even genome editing that would fall within precision breeding, is regulated as GM and goes through a full risk assessment, often involving toxicology and quite a lot of analytics. At the other end of the scale, you have the US, for example, which has a default setting: if it is similar to something that was traditionally bred, there is no regulation.

Perhaps in between, the Canadian example is an interesting one. In Canada, they regulate the product and not the technology that has created it. They ask—let us go for an apple—“If you have created this apple, is it different from an apple I can buy currently?” If it is not different, it is not a novel food and it is not regulated; if it is different, it is a novel food and it gets assessed, regardless of how you made it. If I made that apple by precision breeding and it is different, it would be regulated; if I made it by crossing two apples in my orchard and creating a new apple tree that was different, it would still be regulated through that process. Scientifically, that is a very valid approach, but it means that you encompass within it all of traditional breeding and all the things that are done but not regulated in that way in this country.

--- Later in debate ---

[Jo Churchill]

Q I hope the Committee will indulge me as I ask my final question. Is this a good time to be bringing this legislation forward, given that you have highlighted to the Committee that we perhaps needed to look at our regulation a decade ago?

Professor Dunwell: I think it is very appropriate. Obviously, it follows on from our removal from the EU. As for the legal case that created this, I suppose, concern, most scientists in the UK and the EU realised that it was a sort of perverse judgment when it comes to traditional so-called mutagenesis, where you apply chemicals or radiation—that is considered a traditional method and has been for 50 years. If you go back to the ’50s, there was a society of atomic gardening. That was when atomic energy was “good”. There was a very popular and interesting character who set up the atomic gardening group. She used to demonstrate her plants at Chelsea; she used to have dinner parties and carry round irradiated peanuts to offer to people. It was considered a good thing, but it was a complete unknown. But there was no evidence of any problems relating to it. We can now make particular small genetic changes in a much more precise way, and I think it is a good time for the UK to take a lead and apply the best scientific principles that we have at our disposal.

[Daniel Zeichner]

Q Welcome and good morning, Professor Dunwell. I am going to try to pursue some of the vexed issues of definition at the start of the Bill, and I will ask you first the question that I asked Professor Henderson earlier. Can a precision bred organism contain exogenous genetic material, and if so, how is it different from a genetically modified organism?

Professor Dunwell: I think this comes back to our understanding of genomes. Some of the wording in here comes out of the discussions that we have had within ACRE and the recognition that, probably 20 or 30 years ago, we assumed that one crop had one genome and that was it, but we now know, because you can sequence genomes very easily and quickly, that in fact there is an enormous underlying diversity of genetic material. The number of genes in one variety of maize or corn is different from the number of genes in another. There are also structural rearrangements. You can have great pieces of chromosomes interchanged or moved; it is still a maize plant. These so-called structural variations are an intrinsic part of plant breeding—and also animal breeding. The more we see the diversity of this variation, the more we pick up the fact that many, many plants have DNA that has come from other organisms throughout their evolution; it is the same with animals. Plants have segments of DNA from, say, virus infections hundreds or thousands of years ago perhaps. They have been incorporated into the genome and so, in old-fashioned definitions of GM, those organisms would be considered genetically modified organisms, because they have material from another organism in them. But we accept now that that is the baseline—that many, many organisms have small parts of DNA from many, many organisms. We have nematodes that have plant DNA. We have insects that have plant DNA. These have been moved around during evolution. They do not change the purity of the species. In evolutionary terms, they create the diversity that enables evolution to take place.

That is the background in which the term “natural transformation” has been created. The simple presence of a small fragment or a bit of DNA from another species, which might have been there anyway, is not something that has any impact on hazard or risk.

[Daniel Zeichner]

Q That is helpful. The problem that I and others have with the Bill is that it was explained to us at the outset as addressing a particular issue—allowing gene editing within one specific species. The assurance given was that it would not open the door to transgenic material being introduced, but I have to say that from hearing the evidence of you and others this morning, and from looking at the Bill, I am not entirely sure that is what it does.

I want to press you a bit further on some of these vexed issues of definition. We have “precision bred organism”, “qualifying higher plant”, and the EU now has “new genetic techniques”. We have three new definitions, which the learned societies have suggested in their evidence do not really mean very much. I may be being slightly unkind, but they are not very precise in their definition. The evidence that your committee, ACRE, produced to give guidance, which unfortunately came after the statutory instrument a few months ago, makes for very interesting reading. I will not read it all out—I assure you, Mr Stringer—but it is a very nuanced account of how you might go about coming to conclusions about what any of these things are, but it lacks precision and certainty. As legislators, we are trying to put into a Bill some fairly precise definitions. Am I wrong about that?

Professor Dunwell: No, it is a nuanced approach. It is nuanced because it takes account of the developing science. That is something that our committee does; part of the responsibility of all committees is horizon scanning. We want to see where techniques that we think of as traditional now are in a few years. There will be even better means of changing not just bits of DNA, but perhaps epigenetic effects, which is where you change not the sequence of the DNA but whether the DNA is expressed in a particular cell. That can also have an advantage.

What you see in these definitions is something that takes account of the advance in science. As I said, it takes account of the background genetic variation that exists. There were a couple of papers recently in Nature, for which something like 50 potato genomes were sequenced, and something like half a million quite big genetic variations were identified, in terms of the position of genes. It is against that background that this definition is pitched. That is where we have to take account of the variation. You cannot say now that one particular fragment of DNA is going to produce any particular risk.

[Daniel Zeichner]

Thank you. I will leave it there for the moment.

[Deidre Brock]

Q The Scottish and Welsh Governments have clearly stated their intention at present for precision bred organisms to be regulated as GMOs. How will ACRE’s advice on releases to the environment take account of the fact that the Welsh and Scottish Governments currently have a different approach from Westminster on this?

Professor Dunwell: Well, we realise that the jurisdiction is different. We have observers at ACRE meetings from the devolved authorities—not at every meeting, but they are clearly invited to attend, and some of them do. They can add their own input into the discussions, even though it will not apply within their jurisdiction. Then of course we have the fact that much of the good science goes on at the James Hutton Institute, the Roslin Institute and elsewhere. Those are world-class centres of science doing this type of research. I am sure that among those scientists there is an intrinsic frustration about the political environment that exists, but I am not going to comment on the policy at that level. ACRE as a committee had sessions in Edinburgh some three or four years ago, and we have spoken to the relevant committees directly. I was part of those discussions.