Draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022
(2 years, 8 months ago)
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The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs (Jo Churchill)
I beg to move,
That the Committee has considered the draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022.
It is a pleasure to serve under your chairmanship, Sir Gary. The draft regulations were laid before the House on 20 January 2022. The Government’s 25-year environment plan sets out our continued commitment to protecting and restoring natural resources and to supporting sustainable agriculture. This statutory instrument will help to ensure that we have the regulations that we need to address that.
As a country, we are internationally renowned for our scientific excellence in genetics and genomics. We want our scientists and researchers to be at the forefront of exploring what technology has to offer. The draft instrument uses existing powers under the Environmental Protection Act 1990 to simplify the process of research and development in plants that have been produced by genetic technologies, such as gene editing, where genetic changes could have been developed using traditional breeding methods. It will help us to adopt a more scientific and proportionate approach to the regulation of gene editing, allowing our bioscience sector to test the benefits and safety of new products by simplifying the system, while ensuring that checks and balances are still in place.
Gene editing can improve sustainability and productivity in agriculture by helping farmers to grow plants that are more nutritious and need less fertiliser. The existing regulations are more than 30 years old, and are outdated and restrictive. Over the past decades, advances in genetic technologies have been rapid, but the regulations have not kept sufficient pace to allow us to benefit from advances.
Last year, we ran a consultation on the regulation of genetic technologies, receiving nearly 6,500 responses. All were considered carefully. We sought advice from independent scientific experts, the Advisory Committee on Releases to the Environment, ACRE, which concluded that gene-edited organisms do not pose any greater risk than organisms produced through traditional breeding methods.
The draft instrument will remove certain technical barriers to research and development, such as processing applications, advertising and post-trial monitoring. It will simplify the need for the Secretary of State to give consent on an individual basis. The territorial extent of the instrument is England and Wales, but the application of the SI will be England only. We conducted an impact assessment that is available on legislation.gov.uk.
To be clear, the draft instrument is for non-marketing research and development purposes only. We want to ensure that we are moving forward carefully. The change operates within our existing robust regulatory framework on GMOs and field trials. Any commercial cultivation of such plants will still need to be regulated in accordance with our existing GMO rules. In addition, our established GM inspectorate, run by the Animal and Plant Health Agency, will continue to act as an inspecting body of GM field trials, including the ones enabled by this SI.
I am most grateful to the Lords Secondary Legislation Scrutiny Committee for its consideration of and report on the draft instrument, to which we have responded. I want to be absolutely clear that the gene-edited plants captured by the SI will not contain DNA from different species; they will have precise targeted changes made to their existing DNA. That means that they are considered gene edited, rather than genetically modified. Traditional breeding methods could be used to develop the same plants, but with less efficiency. This will allow us to optimise the benefits faster and with greater ease.
Across the world, other countries are surging forward. We need our scientists and growers to be part of this future. The draft instrument is the first step in our scientific but cautious, step-by-step approach to enable the benefits of gene editing to be realised and to help us to adapt to the impact of climate change, to reduce emissions and to help meet our ambitions in the 25-year environment plan. Indeed, Professor Dale Sanders from the John Innes Centre said that
“Defra’s announcement today is a step in the right direction”,
as
“Gene editing offers an opportunity to revolutionize our food systems.”
In a second step, we will be seeking primary powers to review the regulatory definitions of a GMO to exclude certain organisms produced by gene editing and other genetic technologies from GMO regulations. That will be followed by a review of our approach to GMO regulation more broadly.
Unlocking innovation in genetic technologies will help to harness nature’s genetic resources to make our farming systems productive, sustainable and resilient. We have seen first hand how useful technologies such as CRISPRs—clustered regularly interspaced short palindromic repeats—can be in the medical field, particularly in the rapid roll-out of vaccines and the treatment of cancer. This first step will help to emulate the success of those benefits in agriculture, and will take us a step further towards the goal set out by the Prime Minister of our becoming a science superpower. As such, I commend the draft regulations to the Committee.
Daniel Zeichner (Cambridge) (Lab)
It is a pleasure to serve with you in the Chair, Sir Gary, and I am grateful to the Minister, not just for her helpful introductory remarks but for the pre-meeting discussion we had a few days ago. She has set out clearly the Government’s view on this important piece of legislation. I will make Labour’s position very clear from the outset. We are not going to oppose this SI, but we are not satisfied that the Government have yet set out the clear and strong regulatory framework that is needed to provide the certainty that investors need, the reassurance that the public need, or the protection that the environment needs. All those things are important, but they are also interrelated, because investor confidence does not come without public confidence.
Labour is pro-science and pro-innovation. We want our scientists to succeed and use their skills for good here in the UK, and we know that crop development and innovation has brought us all huge gains. As Henry Dimbleby observed in the opening comments to the national food strategy—to which, of course, we still await a Government response—
“The food system we have today is both a miracle and a disaster”
providing
“enough calories (albeit unevenly distributed) to feed 7.8 billion of us…But the food we eat—and the way we produce it—is doing terrible damage to our planet and to our health.”
We agree, and it shows that we need to find ways to maintain and improve that efficiency, but also address the environmental and health damage that the modern food system has caused.
Some will say that more innovation just brings more problems, risks and dangers. We do not take that view, but we strongly believe that it is right to be careful, because this is about balancing risks, knowing that alongside the benefits—which absolutely should include significant environmental gains, such as reduced use of pesticides—there may be the danger that either mistakes are made, or there are things we simply do not know. That cannot paralyse us from action, because every intervention has risks attached, but we need a system that allows us to manage those trade-offs and those risks, and I am afraid that this SI does not do any of those things.
I am sure the Minister would say that it is not trying to do them: that this is a small step and, as she has indicated, that more will follow. That may be the case, and we agree that this is a relatively small step. It is important to be clear that this SI is about research, not products that reach consumers. However, I am afraid that the failure to provide the necessary structures and reassurances could turn a small step into a much bigger mistake if it fails to provide the necessary public reassurance.
Graham Stuart (Beverley and Holderness) (Con)
It is fantastic to hear the hon. Member for Cambridge speaking enthusiastically in favour of one of the benefits of Brexit. Does he agree that the EU got this wrong and that, with the right provisions in place—I note that he is not opposing this SI—this is a journey to a better place, and one that the EU turned its face against?
Daniel Zeichner
I am grateful to have the opportunity to point out that this has nothing to do with Brexit, because of course the EU has embarked on much the same kind of path. It is already consulting on where it is likely to get to, and it is quite likely that we are going to get to a similar place at a similar time, as I will come on to later in my speech.
It is not just the Opposition who have concerns. The Lords Secondary Legislation Scrutiny Committee has made a series of strong criticisms that Ministers should take seriously, and that I hope Committee members have had the opportunity to consider. Committees in the other place often have comments about statutory instruments, but these are much more substantial than normal. The issue made it into the national print media, and on to national radio. When that level of public interest is generated by a report on the inner workings of this place, it should give the Government pause for thought. As the Secondary Legislation Scrutiny Committee says in its report, the regulations
“are politically or legally important and give rise to issues of public policy likely to be of interest to the House.”
I will briefly outline its concerns.
The Committee quotes the Government’s impact assessment, which makes interesting reading itself, and which I have looked at closely. The Committee cites the view widely held in the industry that the 2018 European Court of Justice judgment has held back research in the UK and the EU. The Committee says—this mirrors comments made elsewhere in the Government’s documentation—that
“the Government now intend to change the law…to allow GM plants that could have occurred naturally or through traditional breeding methods for release for non-marketing purposes. This is to enable the bioscience sector to test the benefits and safety of relevant new products ‘without the burden of unnecessary regulatory processes’.”
That is what this statutory instrument sets out to do, but the act of deregulation does not always lead to innovation; frankly, that is an ideological assertion. Page 1 of the impact assessment says that there is “some evidence” for the Government’s claim, but it does not say what that evidence is. The Minister may have it, and may be prepared to offer it, but others, myself included, would argue that in general it is good regulation, not a lack of regulation, that spurs innovation.
The Lords Secondary Legislation Scrutiny Committee says:
“Regrettably, the EM”—
the explanatory memorandum—
“does not provide any further information on the Government’s plans for wider reform.”
The Minister said in her opening comments, which I welcome, that primary legislation will be forthcoming, and I think she has confirmed that. Perhaps she can tell us a little more, because she mentioned that in our meeting earlier this week. The crucial question is what that primary legislation is designed to do—whether it will deregulate further, as I suspect it will, or whether it will set up, as I would much rather it did, a proper, fit-for-purpose regulatory system. Perhaps she can clarify that.
I am sure that the Minister has read the submission from the Royal Society of Biology to the consultation run by the Department for Environment, Food and Rural Affairs. It is lengthy, substantial and raises a number of interesting suggestions—it is in my pile of papers. It includes ways in which short-term improvements could have been made under existing legislation. Will the Minister tell us whether those suggestions were considered? It also sets out ideas for a future regulatory framework. Again, I would be grateful if the Minister commented on those.
The Secondary Legislation Scrutiny Committee also highlighted points made strongly by organisations such as Beyond GM and GM Freeze about the introduction of the term, “qualifying higher plant”, which is introduced in the SI. The Organic Farmers & Growers group described it as a term it does not “recognise in any way”. This is clearly a thorny issue, as a number of the submissions to the consultation confirm—as far as we can find out, I should say. I do not think that the Government chose to publish the submissions; I am not sure why. Most of the ones I have were found by going back to the organisations that submitted them. Let me give some examples. The Roslin Institute says:
“it is exceptionally challenging to define which changes to the genome could have been produced by ‘traditional’ breeding.”
The Royal Society says:
“this question is problematic as there is a difference between what could be produced by traditional breeding in theory and in practice”.
The Royal Society of Biology says:
“No clear criteria can be described that would determine whether an organism produced by genome editing or other genetic technologies could have been produced by traditional breeding. This means no clarity can be achieved using this principle, and it is not appropriate as the basis of regulation.”
That is a strong statement from experts in the field. I will read out that last sentence again:
“it is not appropriate as the basis of regulation”,
but that is how the Government are proceeding.
DEFRA’s response when pressed by the Secondary Legislation Scrutiny Committee was that the Advisory Committee on Releases to the Environment
“is in the process of developing guidance”
that
“will be available shortly.”
What is “shortly”? The response from the Lords was:
“We regret that the guidance has not yet been published, especially as the Department would have been aware of the concerns which were raised during consultation. The House may wish to press the Minister for an explanation why the guidance has not been made available in time for it to be taken into account by Parliament in its consideration of these draft Regulations. We urge the Department to ensure that the guidance is published in good time before the new rules come into effect and that this guidance is communicated effectively, in order to provide clarity to researchers and those who have concerns about the new policy.”
Well, quite. The guidance should have been ready when the draft SI was laid. Why was it not, and when will it be?
ACRE might be struggling to do something that the Royal Society of Biology and others say is simply not possible. Given that much of this is about retaining public confidence, I took a look at ACRE, on whose advice so much of the draft SI depends. They are seven very eminent and experienced people, and I am sure they do an excellent job, but in the declaration of interests, six of the seven record very direct links with companies that might well benefit from the technology—no fewer than three of them quote Syngenta. I simply say to the Minister: if or when the public look at this, I suspect we know what they are likely to think. Is there sufficient balance and independence? Is she sure that the regulatory framework is right?
The Lords Secondary Legislation Scrutiny Committee’s next concern follows from that uncertainty about the definition of qualifying higher plants, in that GMO developers in effect self-declare whether their product is in that category. Question 5 in the Committee’s list of questions to DEFRA queries that. The answer is that the advice from ACRE is that the risk from genetic technologies is no greater than traditional breeding—well, frankly, they would say that, and that is the nub of the argument. Will the Minister explain why she believes the public will have confidence in that approach, given that there is no way of anyone knowing or being able to find out whether something is being developed with the technology unless those developers choose to declare it? Frankly, with this draft SI, it is just down to trust.
Organic farmers are particularly concerned, given that the new notification measures do not include location, scale or details of containment measures. The DEFRA answer puts the onus on researchers, again relying on trust, which is not enough to reassure organic growers who risk loss of certification. When asked about who would be liable if something went wrong, DEFRA’s answer is, in essence, that it does not believe that that will happen.
Once again, I find myself with the Lords Secondary Legislation Scrutiny Committee on this. Its sensible conclusion was that
“the Department should consider conducting and publishing an evaluation of…new rules and of any environmental or economic damage, to inform the wider reforms that the Government intend to take forward in this area.”
Will the Minister agree to do that, and if not, why not? I appreciate that she may not have an immediate answer to hand on all or many of my questions, but if she committed to writing to me, that would be helpful.
The Lords Secondary Legislation Scrutiny Committee also points out the devolution issues: the draft SI applies to England, as the Minister said, while the Scottish and Welsh Governments have expressed concerns and are not pursuing equivalent changes. That may not be an issue now but, given the discussion about the UK internal market rules—some of us will remember them from some months ago—it is worth noting that there may well be challenges ahead as different parts of the UK take different approaches.
Finally—you will be pleased to hear, Sir Gary—from the Lords Secondary Legislation Scrutiny Committee came the bigger constitutional question of whether this is the right way to proceed on an issue of considerable public interest. The Committee makes a strong case that this should have been done through primary rather than secondary legislation, not least because there is no opportunity for amendment. Within this SI alone, it is clear that there are provisions ripe for amendment and debate, which cannot be done in Committee today.
Let me conclude by returning to the wider argument. The Government’s case, as I understand it, is that the existing safeguards mean that GE research is going elsewhere, not just from the UK but from the EU. As I said, the EU takes the same view and is consulting on similar changes. I suspect it will get to a similar place, but possibly—this is a risk for us—with a better overall regulatory structure. We need to be mindful of that.
If the aim is to allow small and medium-sized enterprises and start-ups to compete against much better-funded bigger players—and that is to be welcomed—they would be making a judgment about which regulatory regime will give them the best future. The Royal Society of Biology makes that point in its submission. That is why we need the right regulation; not only is no or limited regulation dangerous in itself, but it will not be attractive to those who want to take their research further, with regulatory approval from a much larger entity that serves a much bigger market. We want to know if and when that broader regulatory architecture will be available. When is the primary legislation going to be laid? How advanced is the thinking on it? What does the Minister have in mind? These are all reasonable questions that should have been answered before, not after, this initial step.
Will the Minister commit to ensuring that the guidance to be published clearly lays out how the current architecture works and explains precisely who does what and what the roles of ACRE, the Genetic Modification Inspectorate—which is, as the Minister said, a part of the Animal and Plant Health Agency—and the Food Standards Agency are? It is not obvious to many people how those fit together so it would be helpful to have it clearly laid out.
This relatively short SI raises many complicated, important and substantial questions, which will no doubt be returned to when we have primary legislation. As I said at the outset, Labour wants this technology to work. We want our scientists to be at the forefront, but that will happen only if everyone has confidence in the regulatory framework in which they operate. That is the way to get ahead—for consumers, producers and the environment. Get the framework right and we are on to a winner.
The Chair
Jo Churchill
I thank the hon. Member for Cambridge and my hon. Friend the Member for Beverley and Holderness for their contributions. I hope to canter through the questions from the hon. Member for Cambridge, but if I have not fully covered them, I will write to him. I set out in my opening speech that we will seek primary powers as we go forward. I urge him to have a little patience and wait for the Queen’s Speech, when he should be availed of more information as to the timings we hope to have. I am, though, grateful that, through his myriad questions, he showed his underlying support for our industry and for allowing farming to be unleashed.
Many countries around the world have taken the investment of those who are looking into this technology area and flown with it. That is why we have less than 5%—I think it is 4.8%—of the investment in CRISPR technology in agriculture in this country. We should make sure we can drive that investment forward for the 400 researchers who work in this area and for the 20% of capital investment that is spent on research into our seeds and agriculture, so that we can benefit from our advances in this area. That is exceedingly important.
Gene editing can help us to grow crops that are more nutritious, beneficial to the environment and resistant to climate change, disease and pests, which the hon. Member for Cambridge said he appreciated. We also need to support our international reputation of scientific excellence in genetics. This statutory instrument is a cautious first step in our new approach to gene editing. It will help us to take steps towards building international collaboration in science and technology.
Graham Stuart
Is it not so important that, first, we get this right—the hon. Member for Cambridge was right to highlight questions in that respect—and secondly, that we send a signal to the industry, which is going to be so important in tackling the issues my hon. Friend has raised on the future of humanity, that the UK is open for business, is going to be led by science and will have a regulatory regime that is friendly to business and will allow us to be a major centre for tackling some of the biggest threats facing mankind?
Jo Churchill
I thank my hon. Friend for the vast experience he brings as a former Trade Minister. Having recently been on a trip to the Dubai Expo, where I talked about some of our agri-innovation opportunities and we looked at how different societies around the world can beat some of the challenges of ensuring food security, I could not agree with him more.
I wish to reassure the hon. Member for Cambridge, who took some time to articulate how he was not satisfied with the framework in respect of both guidance and investors. The rest of the GMO framework remains unchanged and will do so until we consult in the future, as I set out.
Let me turn to the scientific criterion for the “higher plant” equivalent to plants that could have been produced by traditional breeding methods. The composition of genetic material in individual plants of the same species is subject to high levels of natural variation and selection, which plant breeders have exploited for centuries. Our understanding of plant genomes and the accompanying advances in technology have increased significantly since the previous legislation and enabled scientists to utilise variation more efficiently by making precise changes to the plant’s DNA. Such changes are equivalent to those that could have been achieved by traditional breeding methods. That is what we mean by the classification of a “higher plant” in the provision.
Daniel Zeichner
I hear what the Minister says, but the submissions from a range of learned organisations suggested that it is rather a difficult distinction to make. That is the nub of the argument, which is why the ACRE guidance is so important. Will she address that?
Jo Churchill
Yes, I will indeed. The guidance will help those who conduct the field trials. ACRE is currently in the process of developing the guidance that will help developers who use genetic technologies such as gene editing to make the plants that they want to grow and test in the field for research purposes.
I can provide a summary of the guidance, if that will help. Developers will need to know whether their plants are exempt from GMO restrictions on the basis that they meet the criteria for qualifying higher plants, as defined in the SI. The guidance makes it clear that notification is required in all cases, so I push back at the hon. Gentleman’s suggestion that it is not required. The guidance demonstrates which type of genetic changes can result in higher qualifying plants and highlights examples to illustrate how key criteria on natural processes and traditional methods and selection might be applied. The guidance provides further detail for cases that do not fit into that precise description. We make it clear that developers can always seek a view from DEFRA if they are unsure. As the hon. Gentleman said, if the EU is not currently consulting, it will be shortly, and will move along a similar trajectory.
I think I have covered investment, other than to say that the legislation will unlock private investment because we have some of the greatest scientists and they have been leading some of this work. It is important that we do not hamstring them. Argentina began to regulate GE more proportionately to risk in 2015 and approved 22 new products for research and development purposes—we are only talking about research and development—between 2016 and 2019. We have had only three come forward since 2017. This SI is all about enabling our developers and scientists to move forward.
The hon. Gentleman asked about protection against cross-pollination and the potential impacts on the organic sector. I refer him to the fact that we have 30 years of experience of genetically modified field trials and thus far there has been no evidence that pollen, seed or other plant materials capable of reproduction from GM field trials have affected businesses in the UK organic sector. When researchers notify DEFRA of a field trial, they have to confirm that they will put in place measures to minimise the possibility of reproductive material from the qualifying higher plant that they are to trial affecting commercial crops. The scientists involved are keen to ensure that they are looking only at the results of that trial. Arguably, it is as important to them as to those who surround them that the trial is done in a competent scientific way so that they can rely on the data it gives them.
Daniel Zeichner
I quite accept the point that the Minister is making, but of course the difference is that for the past 30 years people have known where those things have been happening, there have been containment measures and they could make necessary adjustments. The key difference now is that they will not know.
Jo Churchill
There will still have to be a notification of where the trials are ongoing. Arguably, we are talking about looking at traditional breeding methods. We go back to what I know the hon. Gentleman and I will disagree on; however, this is about proportionate risk, and the fact is that we have been doing this for some 30 years. That adds to the bank of knowledge to reassure us that we are safe in the knowledge of moving forward with this very proportionate small step to ensure that we can optimise in the marketplace what we are trying to do, which is to support the plant-breeding sector. As I said, it spends 20% of annual turnover on R&D activities, and it is incumbent on all of us, given the positives that can come out of this, to support it.
In the past three years, we have approved through DEFRA three field trials involving GM or GE crops: camelina plants to produce omega-3 oil; a brassica to lower the level of sulphur-containing compounds, which although beneficial, at higher levels can cause adverse effects in livestock, such as reduced feeding and growth; and a wheat that, when used in food production, results in lower acrylamide, which has been found to be carcinogenic.
Development of GE products can take up to 10 years. In my opening speech, I laid out that we are progressing at a measured and proportionate pace in order to get this right. My intention is to get this right. That is why I can assure the hon. Member for Cambridge that, as we move forward, the consultations into the broader GMO framework will take place. We propose to come forward with primary legislation; that will give him and others the ability to challenge, as we do in this place, to ensure scrutiny.
Moving forward with the broader approach to the regulation of technologies such as gene editing, we recognise the strong public interest to which the hon. Gentleman alluded, but we also recognise that there are gains to be made. He mentioned many of the submissions but he did not mention the one from the John Innes Centre in Norwich, which alluded to the benefits. Many others also highlighted the benefits. We will be taking this step by step. Our approach to regulatory reform will be measured. We want a proportionate, science-based regulation that protects people, animals and the environment.
The UK agriculture sector now faces a situation in which it must do more with less. We must provide nutritionally high-quality food while reducing our use of water and energy, all in the context of a changing climate that makes food production through existing methods more difficult. As I outlined, the changes introduced by the statutory instrument will help researchers and scientists to harness the benefits of genetic technologies with greater ease. I therefore commend the draft regulations to the Committee.
Question put and agreed to.
Resolved,
That the Committee has considered the draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022.