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
(2 years ago)
Lords ChamberMy Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for raising the question of exogenous DNA, which I mentioned at Second Reading, as did she. I am sorry to say that, on this occasion, I disagree with the noble Baroness. I think her amendment goes too far, since, as she explained so clearly, the current techniques of gene editing require the use of exogenous DNA not only for the CRISPR-Cas9 construct but for the insertion mechanism—for instance, Agrobacterium—and for the antibiotic resistance filter used to check that the changes one intended to achieve have been achieved. Furthermore, at the end of the gene-editing process, there could be tiny fragments of this exogenous DNA left in the gene-edited organism. As I mentioned at Second Reading, although there are new techniques being developed that will obviate the need for gene editing with exogenous DNA, they are not yet ready for mainstream use. Hence, in my view, Amendment 11, if accepted, would in effect kill off gene editing for the near future.
Should we be worried about exogenous DNA? The noble Baroness, Lady Bennett, clearly thinks we should. The Bill deals with the issue of exogenous DNA by stating in Clause 1(6) that any remaining exogenous DNA must not code for a protein if the precision-bred organism is to be considered as having been produced by a process equivalent to traditional breeding. Does that provide us with sufficient reassurance?
I am most grateful to Professor Wendy Harwood and her colleagues at the John Innes Centre, in Norwich, for their further advice. My initial thought in considering this problem was that the wording in the Bill could be tightened to say in Clause 1(6) that the exogenous DNA, if there is any left, should have no effect on the phenotype of the precision-bred organism; in other words, no effect on the appearance or biological properties of the edited organism. This would be a more stringent criterion than that requiring that the fragment of DNA could not code for a protein.
As the noble Lord, Lord Winston, so clearly explained to us in his excellent introduction, the principal way in which DNA is expressed in the phenotype is by genes coding for proteins that are the building blocks of life. However, there are also other ways in which nucleic acids can affect the phenotype; I am sorry if this is a bit technical. One example is RNA interference, a molecular process in which short strands of RNA can act to silence a gene. There are other examples of gene regulation by RNA strands that are not transcribed to produce a protein.
There are mechanisms not covered by Clause 1(6) by which exogenous DNA could affect the functioning of the precision-bred or gene-edited organism. Does this justify a change in the wording of the Bill? The view from the John Innes Centre is that it is unlikely that non-coding DNA could exert a phenotypic effect, although this is both theoretically and practically possible. It argues that these possibilities should be tested for in any gene-editing strategy before a product is developed. If this is the case, it would not be necessary to require it by regulation. Furthermore, the scientists at the John Innes Centre argue that the requirement of “no phenotypic effect” might lead to the conclusion that there has to be exhaustive testing for this in an unspecified range of environmental conditions.
I can see both sides of the argument. On the one hand, there is an argument for ensuring that any remaining exogenous DNA has no discernible effect on the phenotype of the precision-bred organism. That would be a more stringent criterion than Clause 1(6). On the other hand, one does not want disproportionate regulation that stifles innovation.
I do not expect the Minister to answer on the technical issues right now but could he—if not right now, before Report—put down in writing an explanation of why making the requirement in Clause 1(6) that any exogenous DNA should have no phenotypic effect would be disproportionate and, if it is disproportionate, whether other steps could be taken to manage the risk of non-coding effects on the phenotype of gene-edited organisms?
My Lords, I thank my noble friend Lord Winston for introducing these amendments. This group explores why “genome editing” has been changed to “Precision Breeding” in the Title of the Bill and throughout it, when, as my noble friend pointed out, it has no scientific meaning. As he said, there is no such thing as precision in biology. He clearly, and in some detail, expressed his concerns about the implications of the Bill. As he also said, as yet there has been no detailed debate during the Bill’s passage around the science. I am sure that we will have that debate in your Lordships’ House, as there are some very eminent people here who know far more about the science than I could ever hope to learn.
My noble friend’s amendments quite rightly probe the Government’s thinking around the terminology. Importantly, he raised the fact that what we need as an outcome of the Bill is the breeding of plants and animals that are free of risk. Again, he talked about the implications of hereditary traits and the fact that the Bill’s focus is on releasing organisms. We need to think much more about how that is happening, and what the implications are as we put the Bill through into becoming an Act.
We know that in the Bill and during the debates—
I am sorry to interrupt the noble Baroness, but I want to make the point that when we talk about “free of risk”, we have to get things in perspective. In so-called conventional breeding, the parent seeds or germline are often irradiated to create a large number of random mutations and then a new cross-bred strain is produced. That often involves shuffling maybe 20% or 30% of the genome and is not regulated at all. When we say “risk free”, we know that conventional breeding is not risk free. The Braeburn apple was introduced 30 or 40 years ago as a new variety—a hybrid of two earlier varieties—without any testing, and that could have had detrimental consequences for human health or the environment. Nothing is risk free, so let us get risk in proportion.
My Lords, I have added my name to Amendment 31 in the name of the noble Baroness, Lady Jones of Whitchurch; I thank her for introducing both this amendment and the other one in this group so eloquently. Amendment 31 makes a modest and perfectly reasonable request. As I said at Second Reading and intend to go on in boring detail about, precision breeding has the potential to be an important tool in the toolbox for creating a doubly green revolution, producing more food with less impact on the environment. If we accept that proposition, we should be in favour of taking into account the wider effects of gene editing.
I do not need to repeat what the noble Baroness said so clearly, but we know without doubt that many of the changes in agriculture that arose during the green revolution were bad for their environments. Loss of habitats, overextraction of water, water and air pollution, greenhouse gas emissions, loss of soil health, loss of biodiversity—those are just a few of the adverse effects of the agricultural revolution that we have enjoyed over the past 60 years or so. Amendment 31 makes the modest request that the advisory committee should take into account these kinds of effects so that, when we create precision-bred organisms, we do not inadvertently make things worse for the environment rather than better. I look forward to the Minister’s response.
My Lords, I support Amendment 31. First, for the purposes of this Committee, 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 for Ecology & Hydrology; and I am the president of the Royal Association of British Dairy Farmers.
Amendment 31 is similar to the two amendments that I put down in a later group on animal welfare, stressing the importance of following new strains of wheat, grass and maize—in my case, cows, pigs, sheep and dogs—down through many generations on to the farm, even into the home. As has already been said, the point is that we need to watch for the good effects, hopefully, but we must also look out for the possible unintended consequences that might arise. To be honest, I would hope that this already happens because, obviously, unintended consequences were even more likely to happen in the past under the random mutations of traditional breeding; if not, such measures should certainly be introduced now. It would be good to be reassured of that by the Minister.
My Lords, I join my noble friend Lord Trees in welcoming the inclusion of animals in this Bill, but I have added my name to Amendment 6, which would restrict the animals in question in the first instance to those involved in agriculture. My main reason for proceeding cautiously relates to the point just raised by the noble Baroness, Lady Jones of Whitchurch, of public acceptance. There is a risk that, if the net is cast too wide with the inclusion of animals, there could be a backlash, which would undermine the whole endeavour.
As the noble Baroness, Lady Bennett of Manor Castle, has said, Amendment 5, which excludes companion animals, is a helpful start. I agree with her that many people would be horrified at the thought that we might breed dogs with further flattened noses through gene editing and that they would suffer the consequences of that.
One can also ask: would the public be happy to see gene-edited wild animals? We discussed that in relation to plants a few minutes ago. One could conjure up examples where the answer might be yes. For instance, if we could gene-edit herring gulls to stop them stealing ice creams and chips at the seaside, that might perhaps be a popular move; but I suspect that, on the whole, people would not be happy to see our native animals gene edited outside the context of agriculture. As it is most likely that the early applications of gene editing in animals will be for agriculture, why not acknowledge this, start here and progress step-wise to widen the range of animals at a later stage if that is deemed advantageous?
The advantage of Amendment 6 over Amendment 8, which refers to farmed animals, is that Amendment 6 would allow for the gene editing of, for instance, a pest or parasite of an agricultural species while Amendment 8 would not. I defer to the noble Lord, Lord Trees, for his expertise on this, but it may in some circumstances be easier to reduce the burden of disease on farm animals by altering the genome of the disease-causing organism rather than the genome of the farmed animal itself.
So, while I am in favour of including animals in the Bill, I think there is a case for proceeding cautiously and, in the first instance, restricting that to agricultural contexts.
My Lords, Amendment 9 is in my name. I will be very brief about that, but I agree that we should be extremely cautious generally about animals at this stage. There is a lot of concern. From the example of dealing with pigs in a genome environment, I know that they are very different from some of the other mammals that we have been experimenting with. We may come to that issue later on when it comes to licensing.
With regard to Amendment 9, there is a strong case as well for limiting this to farm animals, if we go ahead at all—and if we do I would like to see equines excluded, for pretty obvious reasons. Some time ago, when I was working with an anaesthetist who was looking at equine metabolism, it was amazing how suspiciously the horse-breeding industry looked at our work—so much so that we could not share our data on their metabolism. It was very clear that we would have great difficulty with the restrictions that are proposed on that industry.
With regard to the great apes, it would be wrong to consider them in the same way as other mammals. It seems to me that these sapient creatures are so close to humans that they ought not to be included in the Bill. There are restrictions, of course, on the use of rhesus monkeys in research. I have worked with rhesus monkeys, not in Britain but in the United States. As a research worker, I always found that extremely distressing because I saw their response to even just a visit from us, when they knew we were going to do something which they thought would be unpleasant. I feel strongly that there has to be a very strong case for modifying sapient creatures, perhaps even to make them less sapient—so I propose Amendment 9 on that basis.
My Lords, I will speak to Amendment 74 in this group. I thank the noble Baroness, Lady Bennett, for crediting me with knowledge of international law on IP, but in fact I am not very well informed on that. I will raise some questions that were put to me by the Royal Society, which suggested an amendment of this nature. I am also grateful to the noble Baroness, Lady Hayman of Ullock, and my noble friend Lord Patel for putting their names to the amendment. My noble friend Lord Patel sends his apologies; he is stranded in Scotland, as are many other noble Lords, I suspect.
My amendment merely asks the Government to review and publish guidance on the implications of the Bill for the law of intellectual property. This is important because all those involved in the development and marketing of precision-bred organisms need to know where they stand. Are these organisms to be treated, from the point of view of IP, like transgenic organisms or like conventionally bred organisms? GMOs currently enjoy greater intellectual property protection than new plant and animal varieties produced using other breeding technologies, which is justified in part by the greater expense of securing regulatory approval for the cultivation of varieties carrying GM traits.
But intellectual property protections significantly reduce the accessibility of the benefits of genetic technologies, and they also contribute to public concerns about the commercial use of technologies. As we heard at Second Reading, the fact that Monsanto and other companies had patent rights for GMOs and had inserted terminator genes into the plants was a major objection to transgenic crops 20-odd years ago.
If genome-edited products are not treated as GMOs, they should enjoy no greater intellectual property protection than the products of traditional breeding technologies, such as plant breeders’ rights—the noble Baroness, Lady Bennett, also made this point. Members of the plant breeding industry need to be able to breed from each other’s varieties, and it would not be in the public interest if the adoption of genome editing for crop improvement were to compromise the ability of plant breeders to make crosses with each other’s varieties.
Plant breeders may argue that they should benefit from patent protection in the same way as for GMOs in order to recover their costs, including the royalties to which the noble Baroness, Lady Bennett, referred on the CRISPR technology. However, I suggest that the public interest overrides this argument. Therefore, I very much hope that the Minister will confirm that, since precision-bred organisms are defined in the Bill as equivalent to organisms that could have been produced by conventional breeding, they will not enjoy greater IP protection than conventional varieties. Surely this is the logical conclusion.
My Lords, the noble Baroness, Lady Bennett of Manor Castle, and the noble Lord, Lord Krebs, have spoken eloquently to this small group of amendments. The technical aspects of the Bill are complex and he has already mentioned the matter raised by the Royal Society. If a new seed variety is developed using GMOs, as he said, it has greater intellectual property rights than one that is developed using other breeding technologies. If some genome-edited products are not treated as GMOs, they should enjoy no greater intellectual property protection than the products of traditional breeding technologies, such as plant breeders’ rights.
The whole issue of novel foods is affected by the Bill and these amendments. The Royal Society believes that those in the plant breeding industry need to be able to breed from each other’s varieties, and it would not be in the public interest if the adoption of genome editing for crop improvement were to compromise the ability of plant breeders to make crosses with each other’s varieties. I am really sorry that the noble Lord, Lord Taylor of Holbeach, is not here because I feel he would be interested in this section. The ownership of intellectual property needs to be addressed before the Bill moves forward to Report. I agree completely with the noble Lord, Lord Krebs, and I look forward to the response of the Minister.
I do not know who drafted this response but it is a masterpiece of obscurantism, in my view. I do not blame the Minister; he is simply reading out what his civil servants have given him. I could not understand—maybe because I am falling asleep or something, but I do not think I am—whether the answer is that PBOs are equivalent to the plants or animals that could be produced by conventional breeding, and therefore enjoy the same protections, or whether they are different. Will he just nail that point down, with a very simple yes or no? Is his answer that precision-bred organisms are treated as equivalent to those that could be produced by conventional breeding, and therefore they enjoy the same patent protections?
I apologise to the noble Lord if I am sending him to sleep, but this is a complex area. Patent lawyers will dance on the head of a pin on some of these issues. As I said, we have worked with the Intellectual Property Office to get this exactly right and to address precisely the point he made earlier about some of the difficulties that were faced, with large international companies owning the rights to seed entitlements. That caused great difficulty in the past.
I shall just read one bit to him again, and if the noble Lord could try to stay awake, it will be an achievement that I will rejoice in. The Bill does not make any changes to laws associated with obtaining a patent; nor does it alter the process by which an applicant would apply for patent protections. Breeders wishing to patent their precision-bred plant or animal should therefore undertake this process in the same manner as for all other inventions and under the guidance of the Intellectual Property Office.
The Bill is also an attempt to provide precisely the balance that the noble Baroness, Lady Wilcox, stressed. We want to secure the rights of those who are investing enormous amounts of money in the development of these technologies, while also not making it impossible for farmers—precisely the people we want to have access to these technologies—to have access. That is the balance we are seeking to achieve.
I can work only on the best legal advice I am given. There are noble Lords in this Committee whose speciality is intellectual property law, and I am sure they could dance much more dextrously on the head of that particular pin than I.
My Lords, my Amendment 19 would require that a precision-bred organism has been developed to provide a public benefit if it is to be released into the environment. The benefits that are listed in my amendment include, but are not limited to, producing food in a way that protects the natural environment and managing crops or livestock in a manner that mitigates or adapts to climate change. Amendment 21 in this group prevents the release of a precision-bred organism unless its genome has been sequenced and the features that have resulted from the use of modern biotechnology have been recorded. I am looking forward to hearing more about that as well.
Earlier, we talked briefly about climate change and how plants in particular can be adapted to support the future needs that we will have in producing sufficient food. It is important that we find ways to maintain and improve the efficiency, security and safety of our food system while we are developing new legislation and that at the same time we address the environmental and health damage that our modern food system has sometimes created. This Bill gives us an opportunity to look at that and see what we can do to improve those areas alongside the other benefits that people have talked about and to mitigate any adverse impacts that could counteract that.
This Bill presents us the opportunity to create a world-leading regulatory framework that other countries could follow as they develop these kinds of technologies that would provide a clear public good. We recognise that our laws need to be updated to match current scientific understanding. We talked about that earlier in the debate. We want our scientists to succeed, but we also want them to use their skills for good here in the UK. I know that is broad terminology, but I hope noble Lords understand what I mean by this.
To get the legislation right, the Government have to balance certain risks and benefits. We need to have consumer confidence and business confidence; otherwise, all the benefits that could come from the Bill may not happen in the way that we would like. It could mean that we get improvements to environmental sustainability and better food security. A lot of this Bill is obviously around food, but how does it fit in with the much bigger picture that the Government have debated alongside the food strategy, which we all saw—was it last year? I am trying to remember how long ago it was. We talked earlier about different legislations interacting. How will this Bill work with the food strategy? Many of the recommendations were about how our modern food system could be improved and what public benefit could come from the way we farm in future.
The Nuffield Council has made recommendations in its document. One part of that is around aspirations for the UK’s future food system—something that is in the minds of a lot of people who have real influence over the way this technology could be looked at and developed in the future. I was also particularly struck by the evidence given to the Commons Public Bill Committee by Bill Angus, who is a wheat consultant. He noted that the motivations behind the work that he does as a wheat breeder and as vice-chair of the International Maize and Wheat Improvement Center in Mexico can be quite different; there are strong passions that drive both ways of working.
We also know that the Crop Science Centre in Cambridge has done interesting work focused on improving the sustainability of our farming systems—in particular, removing the need for inorganic fertilisers. To me, these are the kinds of areas where gene editing could bring significant benefits for the environment, the sustainability of our food systems, and reducing food insecurity across the world. The noble Lord, Lord Cameron, mentioned these issues in his earlier speech.
It is important that we look at how gene editing could be used for good, because we also know that it can be used for ends that, to many of us, would not be so desirable. Evidence from Compassion in World Farming was very interesting in this area. It talked about some of the harms that traditional breeding has caused—I will not go into detail, as we have heard about that today and at Second Reading. It is important that we work for the public benefit and that the Bill is not used to breed animals in a way that would mean they suffer more or be made to tolerate harsher conditions; the Minister mentioned this earlier. It is important that those questions posed in my amendments are taken account of. How can we ensure that the technology is used for good here in the UK?
There is also the question: who decides what that good might be? We will come on to debate that more to some extent in group 8, where we look at the animal welfare tests, for example. There are also questions around the development of herbicide-resistant crops. Do they allow more herbicide to be used? Is that a good thing? There need perhaps to be more tests in the Bill to make sure that some of the roads that we do not want to go down are not roads that we can go down.
My amendment would create a public benefit test before precision-bred organisms could be authorised and released. It is important that the governance is correct to manage that. Professor Sarah Hartley of the University of Exeter said in evidence:
“The Bill enables science to develop in this area, but it does not enable us to direct the science and technology towards doing any good.”—[Official Report, Commons, Genetic Technology (Precision Breeding) Bill Committee, 30/6/22; col. 123.]
That is the area that I am trying to look at and ask noble Lords to consider. How would we achieve that? At the moment, it is driven too much by market forces. In making legislation, we have to ensure that we guard against those who are, perhaps, not so interested in the good—the public benefit—that can come out of it but looking just at the market forces. We believe that the Bill could be strengthened through this amendment, and the Government’s stated aims, which the Minister has said he wants to achieve, could be encoded within the legislation itself. I beg to move.
My Lords, I thank the noble Baroness, Lady Hayman of Ullock, for introducing this amendment so eloquently. I have added my name to it. In fact, I felt that the amendment was almost unnecessary because, earlier this evening, the Minister referred to precision breeding as being used to create public good—I think I am right in saying that. The amendment tries to flesh that out and ask what is meant by “public good”.
It goes without saying that one objective of farming is to produce food or other farm products. Precision breeding will be used to increase the efficiency, and maybe the productivity, of farming in this country. My noble friend Lord Curry of Kirkharle, who is not in his place, made a useful comment earlier about what is meant by productivity in farming.
It goes without saying that one objective is to increase efficiency and productivity: that is the “more” bit of “more with less”. Equally important, and what the amendment is about, is enshrining the “less”: less harm to the environment and to people. We have been through many times the kind of harms to the environment that intensive agriculture has delivered, and we hope that precision breeding will be used to reverse those harms rather than augment them.
The noble Baroness, Lady Hayman of Ullock, also raised the important point of how bits of the jigsaw fit together. She referred to Henry Dimbleby’s national food strategy. I would be interested in knowing from the Minister whether some of the recommendations that Henry Dimbleby made will be implementable or, indeed, supported by the Bill if it goes through—as I hope it will, possibly with some modifications.
In a way, this is almost uncontroversial. We all accept that there have to be public goods that are supported by precision breeding; that has to be balanced with increasing productivity and efficiency of agriculture; and what we are trying to do here is spell out what those public goods are and should look like. I very much look forward to the Minister’s response.
My Lords, I want to say how much I support this amendment, which has been introduced by the noble Baroness, Lady Hayman. I agree with the noble Lord, Lord Krebs, that it was a very eloquent introduction. It should indeed be uncontroversial, for two reasons.
This Government have committed themselves to a number of welcome targets on climate change. We have not quite got there yet on the environmental targets, but the Secretary of State says that we will perhaps have them by next week. We also have the food strategy. If not set targets, we have a clear direction of travel. If the Government are committed to those targets, be it in the social, environmental or climate sphere, then they have to will the means to deliver it. Whether we are talking about a procurement Bill or this Bill, the Government have all these levers to pull to deliver the outcomes.
It would be almost a dereliction of duty not to will the means in a Bill like this to deliver the environmental, climate and food targets which the Government have so welcomely committed themselves to on the record in other places. If the Government were to miss the golden opportunity to embed this commitment to a public benefit in this Bill, I feel it would leave Members around the Committee worried that some of those commitments were perhaps not as deep as we all were hoping.
Moreover, in the way that the Agriculture Act did, there is an opportunity to shape the market by saying that we will rightly give farmers funding to produce the public goods that we want. The mirror approach here is saying that we will provide this new regulatory framework to regulate the benefits and risks of this new procedure. We will allow companies the investment and growth opportunities if it is clear that they are delivering public goods. It is about shaping the market in a way that delivers those public goods.
My Lords, I am grateful for Amendment 19, which raises the importance of ensuring that what we do has a public benefit. Across government we are undertaking a range of what I believe is really exciting work to deliver public good and we want to see precision-breeding technologies complement this work to improve our food system and the environment.
On my phone I keep some crucial lines from the Agriculture Act, because when I meet farmers and they say that this Government no longer mind about food production I remind them that right at the front of the Agriculture Act, in Clause 1, it says:
“In framing any financial assistance scheme, the Secretary of State must have regard to the need to encourage the production of food by producers in England and its production by them in an environmentally sustainable way.”
That is a declaratory statement right at the front of the Act. What we are seeking to do in terms of environmental land management goes through the heart of that piece of legislation and this piece of legislation fits very firmly within that.
As noble Lords are aware, the UK is privileged in its scientific position and researchers across the country are already delivering exciting research that contributes towards public good in the field of precision breeding. In the other place, the John Innes Centre gave evidence about the vitamin D tomatoes that its research group is developing, striving towards improving the food we eat for the benefit of our health. Another notable example is from researchers at Rothamsted who are exploring ways to increase the lipid content of grasses. This could help improve the quality of animal feed and has the potential to reduce methane emissions in livestock. I think we are all proud of the work taking place in this country and I am sure that the noble Baroness, Lady Jones, is particularly proud of Rothamsted.
This amendment, I fear, might hinder the important research in this area by placing restrictions on and creating significant uncertainty for critical field trials for researchers and breeders attempting to make new varieties of precision-bred crops. While I understand the intention of this amendment—and it is an intention I applaud—it would not be appropriate to restrict technologies used in breeding, nor do we have any evidence that suggests developers are doing anything other than creating better and improved varieties or breeds.
Of course, it is important to note that these technologies are not a silver bullet, and we want them to be part of our innovation toolkit to improve our food system. Delivering public good is what I did say earlier, and I am very glad I did—and it has been underlined by other noble Lords. It is what we strive for across government and we are fully committed to developing a more sustainable, resilient and productive food system.
Noble Lords quite rightly referenced the Government’s food strategy and, building on Henry Dimbleby’s extraordinary, in-depth piece of work, we have set out a plan to transform our food system and ensure that it is fit for the future. The noble Baroness, Lady Bennett, mentioned sugar beet. This is a crop where there is an application which might be of huge benefit, and not just in terms of the food that we produce. Being able to develop a strain resistant to virus yellows would mean that we would not have to seek noble Lords’ permission through secondary legislation for a derogation to allow the use of neonicotinoids to control virus yellows. More importantly, we could have a crop that was not only able to produce more sugar for our producers here but would require us to import less sugar from abroad, thereby lowering the carbon impact of that crop.
There are counterfactuals in everything. Trying to improve the home-grown element of our food, while reducing the impact that failing to produce it at home would create by having to import that food, sometimes from far away, needs to be factored in. It is fundamental to our food strategy.
I thank the noble Lord, Lord Winston, for his Amendment 21, which would require the genomes of precision-bred organisms to be sequenced before they can be released into the environment, regardless of whether or not an organism with the same genetic changes had previously been assessed and classified as precision bred. It also stipulates that the genomic changes resulting from the use of modern biotechnology have to be recorded, that no unprecedented changes can be present in the plant or animal, and that this must be reported to the Secretary of State.
I assure noble Lords that the criteria for defining a precision-bred organism, as set out in Clause 1, consider both intended and unintended changes to the genome. This means that any changes resulting from the use of modern biotechnology, whether intended or unintended, must be able to occur through traditional breeding or natural transformation for a plant or animal to be considered precision bred. It also means that unintended changes will already need to be assessed as meeting these criteria before any precision-bred organism is released.
The noble Lord’s amendment would mean that plants and animals could not be classed as precision bred if they contain unintended genomic changes. Unintended genetic changes occur during the traditional breeding process. Some of these may be removed during that process and others not, as will be the case with precision-bred organisms. As I expect the noble Lord is aware, many recent gene-editing studies about animals have reported no incidences of unintended genomic changes when using CRISPR-Cas9. Having assessed this evidence our expert advisory committee, ACRE, has also advised that unintended genomic changes occur significantly more often during the course of traditional breeding than they do as a result of precision breeding. This is also the view of the European Food Safety Authority, which advises the EU. Consequently, while we expect developers to ensure that any unintended changes are within the range of what can occur naturally, the scientific advice we have received suggests that it is not appropriate to prevent plants or animals with unintended genetic changes from being classed as precision-bred organisms.
We are committed to taking a proportionate approach, requiring only the information that fulfils the regulatory requirement at the appropriate time. It is for this reason that the Bill distinguishes between requirements for research trials and marketing applications of precision-bred organisms. This amendment is likely to add regulatory burden, without adding value to the process. For example, developers would be required to submit a release notice to Defra, confirming that the founder organism they intend to release for research trials meets the criteria in the Bill. They would have generated genomic data to confirm that this is the case.
However, requiring whole-genome sequencing would be disproportionate, given the specific, targeted nature of changes being made. I assure the noble Lord that breeders who release an organism modified using modern biotechnology that does not meet the criteria outlined would be subjected to sanctions under existing GMO legislation. This is a strong deterrent against releasing organisms that do not qualify as precision bred. That also goes some way to answering the point that the noble and right reverend Lord tried to pick up from the previous group, which was not moved. However, we are clear about the sanctions that we want implemented.
Developers will have to submit an additional notification to Defra should they wish to market their precision-bred organism. Breeders will need to provide fit-for-purpose information to demonstrate that they have met the requirements that I have outlined. The technical details will be developed with the advisory committee appointed to advise the Secretary of State on the regulatory status of these organisms.
For marketing approvals, assessments will be carried out on a case-by-case basis. The full genomic sequence of an organism may not be required in addition to information on intended and unintended genomic changes to determine similarity to traditional breeding or natural transformation. As a result, we do not feel it necessary to include a provision that specifically requires whole-genome sequencing.
Finally, to address the noble Lord’s point that the DNA of all progeny of a precision-bred organism should be sequenced before release, if a “founder” organism has met the criteria laid out in the Bill—specifically, that the genetic changes made by modern biotechnology are stable and could have arisen naturally or through traditional breeding—we have been advised that the regulatory status of its progeny does not have to be assessed. This is because the changes made are stable and in line with those that occur naturally.
To address the noble and right reverend Lord’s point about this being a public good, I hope I have set out why the Bill fits in with the Government’s food strategy and how environmental sustainability will be enhanced by it if we get it right. Perhaps the greatest public good will be if we are able to adapt to and tackle elements of climate change that affect not just these islands but countries all around the world. It could benefit some very challenged environments, so we owe it to them to make sure that we are regulating this correctly, making it accessible not just to large multinational companies but to smaller businesses and—to use the rather pompous word I used earlier—democratising it, ensuring that its benefits can be felt far and wide. I hope this provides the assurance that noble Lords need not to press their amendments.
I thank the Minister, but I have one question of clarification, just to check that I have understood what he said—namely, while accepting that it is important that public goods are delivered by precision breeding, that it would in some way stifle innovation if one defined too precisely what one meant by “public goods”. Can the Minister give an example of where saying what one means stifles innovation?