Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022
(Limited Text - Ministerial Extracts only)
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Lord Benyon
That the draft Regulations laid before the House on 20 January be approved.
Relevant document: 29th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument).
The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Benyon) (Con)
My Lords, this instrument before us today seeks to use 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 the resulting genetic changes could have been developed using traditional breeding methods.
Over the past 30 years advancements in genetic technologies have been rapid and have led to the development of a range of beneficial outcomes such as disease resistance. But the regulation has not kept pace with our better understanding of the risks and is now seen by scientists as restrictive and outdated. Genetic technologies such as gene editing include a range of breakthrough approaches that provide a precise way of introducing genetic changes such as disease resistance, making the whole breeding process more efficient and responsive. Field trials do currently take place; however, uptake has been low, with estimates suggesting that no more than two field trials for plants happen in England each year. Leaving the EU has provided us with the opportunity to adopt a new, science-based, proportionate regulatory approach.
This instrument, in practice, will remove certain technical barriers for research and development such as processing applications, advertising and post-trial monitoring of genetically modified plants that could have been produced by traditional breeding. It will simplify the need for the Secretary of State to give consent on an individual basis before propagating plant material is placed into the soil.
I hope it will be useful to provide noble Lords with an example of how gene editing could be used. Virus yellows are a group of viruses spread by aphids affecting major crops such as sugar beet. These viruses can cause yield losses of up to 50%. They are currently controlled using a range of pesticides. Over the past four years, a study funded by UK Research and Innovation has identified several promising sources of genetic resistance against virus yellows. Using gene editing to give resistance to virus yellows would reduce the need for pesticides and help protect crops against the virus, helping to protect the environment, increase food production and reduce costs to farmers.
Last year, we ran a consultation on the regulation of genetic technologies and received nearly 6,500 responses. We considered all the consultation responses carefully and sought advice from the independent scientific experts, the Advisory Committee on Releases to the Environment, which concluded that gene-edited organisms do not pose any greater risk than organisms produced through traditional breeding methods.
In the government response to the consultation, we set out how we will clear a path for genetic technologies such as gene editing through the implementation of a step-by-step approach on how we govern the use of organisms developed using genetic technologies. This SI is the first small and proportionate step in our approach, unlocking science and innovation in an area which holds great potential to help improve the sustainability and productivity of agricultural systems.
Our approach with this SI follows international practice. Other countries, including some of our major trading partners, have already begun delineating regulations between organisms produced by genetic modification and those of genetic editing. For example, the United States passed the SECURE rule in 2020. This means that any GM crop that could have been developed through traditional breeding and which has a history of safe plant-pest use is exempt from the need for regulatory approval.
Across the world, other countries are moving forward in their take-up of gene editing. We are internationally renowned for our scientific excellence in genetics and genomics, yet we cannot fully explore what this technology has to offer. This instrument will help us adopt a more proportionate approach, based on science, to the regulation of gene editing, allowing our bioscience sector to test the benefits and safety of new products by simplifying the current system while ensuring checks and balances are still in place.
Turning to enforcement and monitoring of the SI, I would like to reassure the House that this instrument is for non-marketing, research and development purposes only. The checks and balances I am referring to are existing, robust regulatory frameworks on GMOs and field trials. Any commercial cultivation of these plants will still need to be regulated in accordance with 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 those enabled in this SI. I want to be clear that the gene-edited organisms captured by the SI will not contain functional DNA from different species but will have targeted changes to their existing DNA.
We are pursuing this change with secondary legislation as there are existing powers conferred on the Secretary of State, through the Environmental Protection Act 1990, which enable him to remove certain requirements on GM plants in particular circumstances. This amendment is limited in its scope, revising only the regulatory burden for non-marketing purposes of a small category of GM plants. It does not change the GM status of these plants, as the definition of a GMO is not changed by the SI.
We are committed to pursuing these changes in an open and transparent way. As part of this, guidance is being written by ACRE that will allow developers to determine whether a plant could have occurred naturally or been produced by traditional breeding techniques. It will also cover the process by which notifications must be made to Defra concerning non-marketing uses of “qualifying higher plants”. The territorial application of the SI is England only. Collaboration between researchers in different parts of the UK is unlikely to be affected by the change introduced by this SI.
In conclusion, gene editing has the potential to help improve the sustainability and productivity of agricultural systems by helping farmers to grow plants that are more nutritious, more resilient to climate change and less reliant on pesticides or fertilisers. We are committed to proportionate, science-based regulation that protects people, animals and the environment. Together with other innovation approaches, this instrument will help us adapt to the impacts of climate change, reduce emissions and meet our ambitions in the Government’s 25-year environment plan. I beg to move.
Amendment to the Motion
Lord Benyon (Con)
I am very grateful to your Lordships for a very good debate. I have that difficult balance to achieve of recognising the lateness of the hour and the business to which we must attend, while also answering the very many important questions which have been asked. I will respond to them in no particular order. I am grateful to the noble Baroness, Lady Bennett, for giving us this opportunity to address some of the concerns which she has raised. I am not sure that I am going to win her round, but I always live in hope.
A number of noble Lords raised the issue of different views from different scientific organisations. In the consultation, we received scientific evidence from a range of scientific and research institutes, such as the Royal Society, the Royal Society of Biology, the Roslin Institute, the John Innes Centre and many others. Many responses were nuanced, with some discussing the complexity in defining gene-edited organisms, suggesting that regulation should follow a product or characteristic-based approach where the end product determines the level of risk, rather than the process used. However, in their responses, many institutions pointed to the various benefits which gene editing can provide and supported the Government’s direction to regulate gene-edited organisms differently to GMOs. For example, the Royal Society of Biology said:
“Genome editing is a tool which holds promise and, if appropriately managed, offers a route to achieving many potential and much needed benefits to society … Creating a regulatory framework in which products of genome editing are not regulated in the way that GMOs currently are, is key to realising these benefits.”
The noble Baroness, Lady Bennett, and a number of others, also raised issues of the credentials of ACRE members. This is the one area of this debate by which I have been disappointed. Ministers in Defra appoint the committee members for ACRE, together with Ministers in the devolved Administrations and in accordance with the requirements of the Office of the Commissioner for Public Appointments. In ACRE’s framework agreement, their commitments on openness and transparency are outlined, including recording any actual or potential conflicts of interest arising in meetings, and the action taken to handle them, as per the Nolan principles. If we want to get the best people in this field, it is very likely that, at some point, they have done a piece of work for an academic institution or company—it is very hard to find someone who has not. Frankly, I would want people with real expertise and who are governed by very strict rules, as the outlined by the Nolan principles.
A number of noble Lords and Baronesses raised the issue of divergence with the devolved Administrations. The regulation of GMOs is a devolved matter. We wrote to devolved Administration Ministers after the release of the Government’s response, stating our intention to bring forward an SI on gene-editing plant research and development.
To address the point made by the noble Lord, Lord Krebs, the devolved Assemblies will not be making an equivalent regulatory change in their jurisdictions, as he said. Consequently, the territorial application of this SI is England only. This means that for any field trials being conducted in Scotland and Wales, scientists will have to continue risk assessments and seek formal consent before trials can commence. That regulatory divergence should not cause any issues for researchers, developers or the public. However, we are aware of leading research on gene editing that is being conducted in devolved Administrations, such as at the Roslin Institute and the James Hutton Institute in Scotland. We are aware that the NFU is supportive, including NFU Scotland.
As a number of noble Lords have pointed out, the EU is moving in the same direction as us, although not quite as fast as we are. Scotland has legislation that says that where possible it will mirror changes in policy in this area in the EU, so it could be that Scotland will pursue a similar route in time. That is up to Scotland. Our English institutions will work closely with the institutions that I listed because there is enormous interest north of the border and in Wales in getting this right.
The issue of guidance was raised, rightly. ACRE is in the process of developing guidance that will help developers wishing to undertake field trials with plants made using genetic technologies such as gene editing, and it will be finalised before Easter. If I may give a hint, developers will need to know whether their plants are exempt from GMO restrictions on the basis that they meet the criteria of a “qualifying higher plant”, which is defined in the SI. The guidance makes it clear that notification is required in all cases and that it is not necessary to seek formal confirmation from Defra regarding its qualifying status. The guidance demonstrates which types of genetic changes can result in a qualifying higher plant, and highlights examples to illustrate how key criteria relating to natural processes and traditional methods and selection might be applied. Further detail is provided for cases that do not fit these precise descriptions, and we make clear that developers can always seek a view from Defra if they are unsure. As I say, that will be available in detail before Easter.
Reflecting some of the concerns of the Secondary Legislation Scrutiny Committee, there has been a question about why this is being done as secondary legislation. We believe that the SI is limited in its scope—that is reflected in points made by the noble Baroness who leads for the Labour Party—revising only the regulatory burden for non-marketing purposes. On the question from the noble Baroness, Lady Parminter, about retail, there will be no retail; any produce from these trials will be destroyed. However, I think her point is wider than that, and if it then goes on to be licensed then of course transparency and labelling are issues that will be debated vigorously at that time. We have existing powers through the Environmental Protection Act 1990 that enable the Secretary of State to remove certain requirements on GM plants in particular circumstances, and that is why we think this is the right mechanism for bringing this to your Lordships.
A number of people have asked about off-target effects and the issue relating to organics. A number of noble Lords have referred to their entries on the register of interests. I did not. I am a farmer—I used to be an organic farmer. I did not think I had to declare an interest because this is nothing to do with farming; it is simply about trials. However, I am happy to declare my interest on the record. The advantage of gene editing over traditional breeding methods is that the genetic changes that it makes are more targeted, which makes the breeding process more efficient and responsive. Using gene-editing techniques means that off-target effects become more noticeable and in some cases predictable, allowing us to manage and control those off-target effects.
Points were also raised about the safeguards and containment measures of the plant field trials, including the risk, as I say, of the cross-pollination of the organic sector. I make this very clear: some of the information put out by campaign groups in their advice as to how to respond to our consultation wrongly hinted that this was some sort of deregulatory splurge that the Government were undergoing. I can assure noble Lords that that is not the context at all. This is a small, proportionate, science-based change to allow the right sort of research to take place. We are not deregulating.
We have more than 30 years’ experience of GM field trials in England which have not caused environmental damage. There has been no evidence thus far that pollen seed or other plant material capable of reproduction from GM field trials has affected businesses in the organic sector in the UK. The off-target effects occurrence rate can be below 0.01% in some cases and techniques such as CRISPR, which some noble Lords will be aware of, mean that we can detect and control them efficiently. Of course, the GM Inspectorate, run by the Animal and Plant Health Agency, will be monitoring this very closely.
This SI amends only the regulatory requirements for non-marketing purposes—a point I made earlier. The commercial cultivation of these plants and any food products derived from them will still need to be authorised in accordance with existing GM rules.
Another issue raised was public perceptions of this. Our social scientists undertook a detailed analysis according to established approaches which took account of all the responses and aimed to transparently report the findings of the consultation. We also consulted the independent scientific experts, ACRE, which concluded that gene-edited organisms do not pose any greater risks. After taking all responses and evidence into account, we decided to adopt a step-by-step approach to the regulation of gene-edited organisms that is science-based and proportionate. On the comments about public perception, other sources of public insight give a different, rather more informed view, I believe, of this type of technology, with 57% of participants not at all or not very concerned about it. A BEIS survey from 2019 found that 63% of participants supported the use of this kind of technology for disease-resistant crops, 65% supported it for crops resistant to adverse weather and 56% supported it for increasing the health benefits of fruit and veg.
The noble Baroness, Lady Parminter, raised the Aarhus convention. The Government consider that the approach being taken through this SI, further to the recent consultation exercise, is consistent with the UK’s international obligations. On public access to environmental information, under these regulations, researchers intending to release a qualifying higher plant for the purposes of a field trial must provide information about the project and this must be published on the register, which will be housed on GOV.UK.
I am conscious of time so I will rattle through two or three more quick points. The precautionary principle is key. The qualifying GM plants covered by this SI do not pose a greater risk to human health or the environment than their traditionally bred counterparts. Therefore, this is not a move away from the precautionary principle. We are committed to proportionate, science-based regulation that protects people, animals and the environment. I have read the EU Commission’s guidance on the precautionary principle, but that is a debate for another day. It is quite clear that we have veered away from the original intentions of the precautionary principle and that can very often be damaging.
I want to thank other noble Lords for raising a number of different points. We benefit from the wisdom and experience of my noble friend Lord Jopling, which goes back many decades. He is right to point out the wider benefits of this type of technology. The noble Baroness, Lady Bakewell, was right to plead the case for an open and transparent process, and I hope we have that.
I conclude by reminding noble Lords that, on almost anything I have ever dealt with at Defra, you can find science which supports a contrary view. I believe that the weight of scientific opinion on this is clear that this is a proportionate approach that will benefit society and allow this country to remain at the forefront of this kind of technological research. I commend the instrument to the House.