Genetic Technology (Precision Breeding) Bill (Fourth sitting)

Katherine Fletcher Excerpts

Committee stage
Thursday 30th June 2022 Public Bill Committees

[Deidre Brock]

Q We received a briefing from GeneWatch UK, in which it talked about its concerns about a potentially significant impact on trade. As you perhaps know, the Scottish Government are waiting for the EU to complete its consultation on gene editing and GM, and the difference between those two, and whether or not it may allow them to be permissible within Europe as well.

GeneWatch UK said that if exempt GMOs are not traceable—because they are considered to be, as we have heard from several witnesses, the same as conventionally bred organisms—manufacturers should be required to publish a validated test for each GMO released. It suggests that all countries that require such organisms to be regulated could potentially refuse all imports of food and other products that contain that exempt GMO. Could you just expand a little on that for us? I would be interested to hear your points of view.

Lawrence Woodward: If I have understood GeneWatch UK’s position, it is pointing out one of the aspects of this situation, namely that if England proceeds by itself —isolated, without regulatory alignment—that would raise all kinds of trade transparency marketing issues, which are not really addressed and which the Regulatory Policy Committee identified as not being really addressed in the impact statement. You then have dysfunction in regulation and alignment, which leads to confusion in the marketplace, and I think that GeneWatch UK was pointing out the fact that England might allow non-labelling and non-traceability of some of these products would not carry a weight in other markets.

There are many different ways of dealing with that situation. What is absolutely clear is that there needs to be in this Bill greater consideration of traceability throughout the supply chains so that the market can function, and both farmers and consumers have choice. There are different ways of doing that.

GeneWatch UK pointed to the need to develop specific analytical tests. Those analytical tests are being developed. Robin May at the Food Standards Agency pointed out—I think he made some comment that labelling is useless if it cannot be verified. In theory that is true but, first, analytical tests do exist, they are being developed and they can be developed faster. Secondly, we already have in a lot of areas geographical identification and source of origin identification—in egg marketing, whether they are free range eggs or barn eggs. We already have marketing verification based on provenance and audit trails. There is no reason why traceability cannot be built up on that, if the right kind of mandatory information is put in the Bill.

There is a separate discussion about labelling. Obviously, we are in favour of labelling. How that would be, where it is and so on—we recognise the difficulties.

Pat Thomas: To add to that, we have heard a lot over these sessions about how it is not possible to trace these organisms and that simply is not true, particularly for a patented organism. There must be something in place to trace that, in order to protect the patent. So, alongside the development of these organisms, there is also the development of the tests to trace them. The question is whether we will put those into effect or not. I would assume that if the developers want to protect their patents they would want to ensure that those tests are there and available.

[Katherine Fletcher (South Ribble) (Con)]

Q There are a number of things that I think we have heard robust evidence on, but you have clearly spent a lot of time looking at this in a global context. Countries such as Canada, Japan and Argentina are forging forward and allowing their scientists to develop new lines and strains to move forward their agriculture. Do you have any comments on how they are doing it? In all candour, I am worried that, to prevent worries and questions such that you are raising, we almost throttle something that has the potential to be genuinely transformative. What assessment have you made of what Canada, Argentina and Japan, who are forging ahead, are doing?

Lawrence Woodward: People often forget in this conversation that European research establishments overall have made an awful lot of research investment into GMO technology and gene editing technology. Some great work is being done in UK research establishments. It is not that we have a block on this. On how much faster would deregulation, in terms of what is envisaged in the Bill, increase that research activity, others can speak more on that. It is not entirely clear to me that that is the case. It might be a benefit in terms of increasing inward investment from multinational companies.

[Katherine Fletcher]

Q I can believe that. It is already happening out there in the world, I just wondered what you thought about what was going on in Canada, Japan or Argentina?

Lawrence Woodward: The impact statement pointed to the development of research in Argentina by pointing to the increase in the number of patents that have been registered in Argentina since it altered its regulation. You might say that is a proxy for research and development activity. It is not necessarily. There is not really that much published information that says how much research is going on, who is funding it and where it is being funded. On the development of traits and the interesting science, it is not clear that it is any greater in Argentina or Japan than it is in Europe and the UK.

[Katherine Fletcher]

Q Sorry, what I meant was, obviously they have stuff in place and they have some sets of regulations in their countries to address your concerns, along with the laws that they have passed to allow gene edited, precision bred products. I wondered whether you have looked at what they have done to protect the safeguards while being able to forge ahead with scientific research.

Pat Thomas: In all those countries, the answer is that it depends. There is a patchwork of regulation throughout the world, with not much in the way of harmonisation. What is very clear is that the media narrative around these countries deregulating gene editing is exaggerated. In some countries such as Argentina there is a much more nuanced type of regulation that looks at things on a case-by-case basis. It is not a wholesale deregulation, which is what we are looking at here. That puts us out of step with those countries. China is the latest one to come on, again, with a much more nuanced approach to regulations. I think you have looked at the Canadian regulations, Lawrence.

Lawrence Woodward: The Canadian regulation is product-based but with a greater analysis of where the end product differs from conventional, so there is a trigger mechanism. I am probably still not understanding what you are asking. In the last five years we have had a lot of discussions with conventional researchers, GMO developers and so on. One of the telling things in our roundtable on the use of genome editing in animals was that the research and development very much depended on the commercial partnerships and roll-out. That very much depended on the markets that those companies could see. That depended on the type of agriculture that they were seeking.

It is not a surprise that most of the development is going into pig disease and those conditions that effect elite breeding lines, because that is where, for the breeding companies, the genetic ownership sees most return. That is not to say there will be no spill-over or benefit to small agroecological farmers and so on, but that is not the thrust. The thrust is about the commercial roll-out.

Pat Thomas: I think what you are asking is whether consumer concerns are being taken into account.

[Katherine Fletcher]

No, I was—

--- Later in debate ---

[Deidre Brock]

Fascinating. Thank you very much.

[Katherine Fletcher]

Q We spoke in a previous evidence session about the difficulty of codifying the beautiful complexity of biology into law, because biology in and of itself is not in a static state. I think the quote was, “Biology is not physics; it’s not a specific number.” So I am sympathetic to some of the comments that you made earlier. What I want to chase with you is what the consequences of the uncertainty in the drafting are. I cannot understand why someone would want to say that something has been genetically edited when it has not been, and I cannot understand why someone would want to say that something has not been genetically edited when it has been—and that is an expensive process. You have much more experience, so what are the consequences of the uncertainty in the drafting?

Dr Edenborough: The long and the short of it is that a single entity can say different things to different people in different contexts and therefore, in essence, confuse and confound people. You can secure rights in a place by saying one thing and then perhaps avoid liability in another place by saying the opposite.

[Katherine Fletcher]

Q But there is no risk to humans, no risk to health. This is about a commercial give and take, in effect. That is the consequence of the uncertainty in the drafting.

Dr Edenborough: No, there might be risk. This is a circular definition, in some senses. You do not need to regulate these matters, because these things can result from a traditional process, or natural transformation. It is because of that that there is a low risk. But that is actually answering the question: you do not actually know whether the thing really could have been—

[Katherine Fletcher]

Q No, it is not—forgive me, Mr Stringer; shout if you want me to stop. The classic example is that Belgian Blue cattle, through a natural genetic mutation, ended up with double-muscle haunches. Everyone thought this was wonderful because you have a cow with a massive bum that is more saleable for the same food. But then there was the discovery of consequences about birthing and ease of birth, and it was dropped out. So I do not think saying, “It could have occurred naturally,” and saying, “It is risk free,” are the same thing.

Dr Edenborough: Perhaps we are talking at cross-purposes. The things that can occur in nature are not always risk free. So that agrees with what you have just said. But one of the underlying justifications, as far as I can ascertain, for this Bill and for removing onerous regulation, is that, because these things are supposed to be potentially capable of resulting from—“could have resulted from”—a natural process, it is likely that they would not be harmful, and that is a fallacy.

[Katherine Fletcher]

Q Biology can make mistakes—some mistakes are positive, and some are deleterious. But gene editing allows us to press fast-forward; it is a speeding up of the opportunity that natures engages in, but within an individual species. That is all true, but it is just happening faster, and with more opportunity and structure behind it, so we can go, “Actually, no, don’t do that—it’s a bad idea.”

Dr Edenborough: It is not just a speeding up, in the sense that the way in which it would occur naturally is probably one step at a time. Here you are allowed to take many steps, so what might have been stopped at step 1, you suddenly get to step 5. Therefore, that could be a fundamentally different thing that you are releasing into nature.

[Katherine Fletcher]

Q That is not my understanding. What you are saying, in effect, is that what we do not want to be doing is creating a plant that is both drought-resistant and has a natural pesticide resistance, and—steps 3 and 4—tastes better and has vitamin D in it. You do not want to do all those in one go. I can see that argument, but surely the regulatory regime in the Bill will allow for people to say, “No, that is just a bit too complicated, when you have to go through the phenotypic analysis at the back of it.” But I want to come back to the core point: what are the consequences of having to accept the biological uncertainty within the way we describe things? What bad is going to happen?

Dr Edenborough: I think it comes back to the point you just mentioned, which is that if you are doing one step at a time, the way in which the Bill will work is that you will probably be allowed to do that, but if many steps are taken, you may not be allowed to do that. The question is on the “may”: who is going to act, in essence, as the gatekeeper on how many steps you are allowed to do at any one go?

[Katherine Fletcher]

Q I presume it would be somewhere between the market and the regulator, and we have heard about the importance of that. If you are going to go far down and take multiple steps, you are going to have to know that you are going to get a commercial return at the end of it, because this is not cheap or easy. So in the other instance you were mentioning earlier, I was thinking, “Okay, that could make it much more expensive to do, but then it is going to get disintermediated by something that is not as expensive.” I hold to the view that law and biology are always going to do this and we have to make sure that we have got ourselves protected against any big negative consequences. That is why I keep pressing you on the “for instance”.

Dr Edenborough: It falls back to the discretionary nature of the way in which the notification process and the control are exercised. If it is discretionary, it could be more or less active. That is the long and the short of it. You are going from a regime that is quite tightly controlled, and therefore every step is controlled, to one where you are allowed to jump through many hoops in one go, because the regulation allows for that in a discretionary sort of way. By having the discretion, you introduce greater uncertainty and therefore greater risk.

[Katherine Fletcher]

Q Okay, but if I flip it the other way and you do not have the discretion, you are effectively closing off avenues to what biology will do naturally. If you want to say, “No, we can only do this, this, this and this”—

Dr Edenborough: No, you are just closing off the pace at which you could do those things.

[Katherine Fletcher]

Right. I am very grateful for the exchange.

[Kerry McCarthy]

Q May I ask about liability? I hope this is within your remit. What happens if an organic farmer finds that there is contamination? Does the Bill provide any mechanisms or safeguards for people who might want to resist going down this path and are affected by it?

Dr Edenborough: Very minimal safeguards. I think you are talking about the potential release of an edited genome. What happens if it breaks out into the wild and then, for example, goes into the field next door?

--- Later in debate ---

[The Chair]

I want to try to get two questions in, very quickly.

[Katherine Fletcher]

Q I will be very brief. There were tanks of fish when I was at university and I have seen the distress that sea lice cause to salmon. It is a problem that has been impenetrable to science, so I can see why that is exciting. My question, as someone who is going to practically implement this, is not necessarily about the technique for inserting the change, but about the thing that is concerning most people. How are we absolutely certain that we have made a very specific change and we have not missed a bit or left a bit of rogue DNA in the wrong place? Can you briefly talk about what you would do within Benchmark Genetics to ensure that, in the nicest possible way, you were getting what you had paid for?

Ross Houston: I see what you mean. Of course CRISPR, the technique we are focusing on, is making a double-stranded cut to the genome and allowing the cells’ natural repair mechanisms to repair the cut and either introduce a small deletion or a small change, or possibly insert a synthetic template of DNA, which would essentially be changing the sequence in a slightly more precise way. There are a couple of parts to that.

In terms of the potential for the CRISPR molecule to make cuts elsewhere in the genome—called off-target effects—we would have to be doing some fairly rigorous DNA sequencing of our animals to ensure that we are not detecting any of those off-target effects. My opinion is that we are now getting very good data from research experiments showing that off-target effects are very rare, and as we learn more about the genomes of our species we are able to design the guide RNAs to take to a specific part of the region that is unique and precise. I see that as a very small risk, but also one that it is important to address.

[Jo Churchill]

Q Did I catch you saying that the Scottish Government are funding precision breeding work within your institute?

Ross Houston: Yes. I moved job recently; I was working for a number of years at the Roslin Institute doing academic research together with industry. The Scottish Government centre, the Sustainable Aquaculture Innovation Centre, is funding projects using precision breeding technologies as a research tool with the goal of—