What you need to know about gene editing in agriculture

NFU specialists have answered questions on this technical subject, following the launch of a Defra consultation on gene editing.

Are there trade implications if the UK starts growing gene-edited crops and the EU doesn't? Could gene-edited crops be grown alongside conventional and organic crops? Why does the NFU support gene editing? How do opinions differ between the devolved nations?

All these questions and more are answered below by NFU specialists following the Defra consultation on the regulation of genetic technologies, which closed on 17 March 2021.

What is the difference between gene modification (GM) and gene editing (GE)?

GM technologies involve inserting new DNA into an organism’s genome, giving the resulting plant or animal desired characteristics. Gene editing is a group of technologies that make the changes within the organism's own DNA by moving, adding or deleting precise pieces of genetic material. Such changes are what happens randomly in conventional breeding, and can also come from mutations induced by chemicals or gamma rays, as with pink grapefruit or the malting barley variety, Golden Promise. Watch wheat geneticist Cristobal Uauy explaining crop breeding and gene editing to the 2019 Oxford Farming Conference. This video from UCDavies explains livestock gene editing in two minutes. You'll find plenty more talks like these on YouTube.

How is gene editing currently used in agriculture and horticulture?

According to available information, there are two crops currently authorised for commercial distribution that use GE technology and are not regulated as GMOs: Calyno, a healthier oil (high oleic, low linolenic resulting in reduced trans-fatty acids associated with cardiovascular disease) is produced from a variety of gene-edited soybean and has been on the US market since 2019. And in December 2020, Japan authorised a genome-edited tomato with higher levels of a blood pressure-lowering compound, with seed distribution planned for spring/summer 2021 and voluntarily labelled as GE. Products in the next few years from technology company Calyxt are likely to include a high-fibre wheat and a reduced-browning potato.

What possible applications are there for gene editing in farming?

There are gene-editing applications in 46 different crop species, with rice, tobacco, tomato, maize, wheat and soybean among the most cited. A very broad range of products with market-oriented traits are being developed, and not only those with agronomic traits - such as yield and disease resistance - but also ones with consumer-facing traits, such as lower allergenicity, high anti-oxidant, longer shelf life, vitamin enhanced. There are also those with climate-resilience traits, such as drought and salt tolerance.

Most recently, scientists at Rothamsted Research and the University of Bristol have used gene editing to develop a type of wheat that is less likely to produce acrylamide when baked. They are applying for a field trial starting in autumn 2021 - the first such trial of gene-edited wheat to be carried out anywhere in Europe.

In livestock, gene-editing applications being developed in research include: porcine reproductive and respiratory syndrome virus (PRRSV) and African swine flu resistance in pigs; bTB resistance in cattle; mastitis resistance; hornless cattle; chickens that cannot spread bird flu; elimination of milk allergen; increase lean muscle.

Why does the NFU support gene editing?

The central principle of NFU biotechnology policy is choice to access the best available tools to farm sustainably and profitably. Biotechnology is not a silver bullet, but the NFU sees great potential in new precision breeding techniques, such as gene editing, to tackle challenges associated with climate change, nutrition and crop and livestock disease. We would therefore like to see more R&D in applications of value to British food and farming; and a well-functioning, fit-for-purpose, evidence-based legislative process to regulate their use.

Much more detail on, and the evidence behind the NFU’s policy position, can be found in our response to the 2021 Defra consultation.

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How are genetically modified organisms (GMO) and gene editing currently regulated?

To protect human health, the environment and ensure consumer choice, there is strict legislation controlling the deliberate release into the environment of GMOs.

There are three main parts to legislation of GMOs at EU level: Deliberate Release; Food and Feed; Traceability and Labelling. For now, the UK is retaining these in domestic law through the Environmental Protection Act, and separate regulations on deliberate release, food, animal feed and traceability and labelling. It is a devolved area of law. The FSA has responsibility for risk analysis in the authorisation of GM food and feed with advice from its Advisory Committee on Novel Foods and Processes (and FSS for Scotland), with Defra and devolved administrations as the competent authorities. Release of a GM organism or import and marketing of a GM product (eg. seed, food, feed, animal, vaccine) requires formal authorisation. The assessment process considers potential safety factors, such as toxicity, allergenicity, and any possible transfer of novel genes to other organisms. Applicants provide a dossier of relevant information and this is scrutinised by Defra’s independent Advisory Committee on Releases to the Environment (ACRE).

It is not yet determined how gene editing will be regulated, here, in the EU and in many countries around the world. Defra is currently considering the responses to its consultation on future domestic regulation of genetic technologies. In July 2018, the European Court ruled that any and all mutagenesis breeding technologies should be regulated as a GMO, except those with long history of safe use (but MS could regulate these as GM too if they wish). At the time, the UK strongly opposed the ruling, as did many organisations and countries within the EU. At the end of 2019, the EU Council asked the EU Commission to review the impact of the ruling, to analyse the link between biotechnology and the Green Deal Farm to Fork Strategy, and recommend how GE should be regulated. The study was published at the end of April 2021, with an initial focus on plants, and the next steps being an impact assessment and further policy action.

Are there differences of opinion between the devolved nations of the UK when it comes to gene editing?

The NFU is aware that regulation in this area is a devolved matter. However, the UK internal movement of goods is determined by the UK Internal Market (UKIM) Act, passed in 2020. In practice, this means that goods produced using methods legal in one part of the UK but not in another can still freely move throughout the UK (but noting that the Northern Ireland Protocol overrides the UKIM). Furthermore, goods legally imported into one part of the UK can then freely move throughout then UK. In terms of gene editing, this means that should England authorise the use of gene editing in agricultural production, but Scotland and Wales do not, then goods produced in England using gene editing techniques can legally be sold in the other nations. This may lead to a competitive disadvantage for Scottish and Welsh businesses.

We also note the Scottish government and Welsh Assembly government have both been clear in their opposition to cultivation of GM crops in their countries. Imminent elections, Defra’s action plan post-consultation and what happens in the EU will all impact whether or not devolved administrations differentiate between GM and GE. ScotGov has said it will wait for the outcome of the EU commission study on future regulation of GE and is expected to align with the EU position, while the SNP is reported as having softened its stance on GE. In Wales, Minister of Environment, Energy and Rural Affairs Lesley Griffiths has also stated that Wales will maintain a precautionary approach to genetic modification, including gene editing. The Northern Ireland position on gene editing is not entirely clear, but in 2015 Stormont decided to not allow GM cultivation, when EU member states were given sovereignty to do so; and the chairman of Stormont’s Committee on Agriculture, Environment and Rural Affairs was cautious in his reaction to the consultation, citing concerns about divergence and disruption.

Why is the change in regulation Defra is proposing needed?

The science of genetic improvement is fast moving and new breeding techniques, such as gene-editing, are now widely used in the research community and are emerging commercially around the world. The way these NBTs should be regulated is the subject of debate and regulatory reform globally driven by the fact that the majority cannot be described as GM as currently defined. There is a recognition of the particular potential value of these techniques to tackle intractable challenges and the important role of legislative frameworks in enabling R&D and access. Experience from Argentina shows that a separate approach for GE has led to a greater diversity of crops and traits and greater access by SMEs and public sector research.

In the EU, the ECJ ruled in July 2018 that any and all mutagenesis breeding technologies should be regulated as a GMO, except those with long history of safe use. There was consternation across EU institutions, member states, industry and the science community at the negative impact on innovation and sustainable agriculture. The EU Council asked the EU Commission to review the impact of the ruling, to analyse the link between biotechnology and the Green Deal Farm to Fork Strategy, and recommend how GE should be regulated. The study was published at the end of April 2021, with an initial focus on plants. The next steps are an impact assessment and further policy action. 

In November 2020, an EFSA assessment concluded that gene editing techniques do not pose more hazards than conventional or GM breeding. It concluded that existing risk assessments are applicable but with fewer data requirements. 

Defra has consulted on a proposal that, for England, it sets aside the 2018 European Court ruling and aligns with other countries such as Argentina, Australia, Brazil and Japan. The government position “follows the science, which says that the safety of an organism is dependent on its characteristics and use rather than on how it was produced” and therefore proposes that legal definitions should say “organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods”.

A statement is expected from government in mid-June 2021, in light of the consultation responses it received.

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Should gene-edited crops and livestock be regulated in the same way?

The underlying principles of fit-for-purpose and science-based regulation that ensure food, feed and environmental safety and animal welfare should be the same. The regulatory status of specific applications should be assessed on a case-by-case basis and in the context of existing legislation on breeding.

There are different rules and systems regulating breeding and production of crops and livestock, into which any new framework for gene editing would have to fit. Discussions are ongoing between government, industry and scientists about how to ensure proportionate protections and requirements are in place in terms of food and environmental safety, animal welfare, intellectual property and economic returns. 

Are there any trade implications if the UK decides to align with international regulatory definitions of GM and gene editing while the EU maintains its current approach on GE?

The continued political nature of trade discussions both within UK and with EU makes it difficult to predict impact on market access and movement of goods. With robust risk management controls in place, ensuring health and environmental safety are not compromised, we believe the UK should continue to be able to trade with the EU on the basis of these rules. Other third countries, including major exporting nations such as Argentina, Brazil, Australia, Canada and the US, already regulate gene editing techniques differently to the EU. Indeed, the EU relies heavily on GM protein feed from these countries.

There are reviews and consultations ongoing by governments around the world looking at how best to regulate gene editing and other new breeding techniques. In practice, commercialisation of gene edited crops and livestock in the UK is many years away, by which time the EU will have set out a clearer and hopefully more pragmatic position based on the technological, commercial and regulatory situation around the world. Some EU-level organisations also responded to the Defra consultation, with a link being made with how the EU will deliver its 'Farm to Fork' strategy and 'Green Deal' if new breeding technologies are strongly discouraged by inappropriate legislation. The EU Commission study published in April 2021 suggests such positive change will come, saying that current legislation is not fit for purpose for some new genetic technologies and their products, and that it must be adapted to keep pace with scientific and technological progress.

Why do we need this in addition to supporting agroecology and integrated pest management (IPM)?

Breeding is an important part of both agroecological approaches and IPM, which are, by their nature, integrated and advocate using a range of different tools and practices. There are no silver bullets in farming. No one technology, system or practice provides all the solutions and the NFU supports R&D and enabling regulations to ensure options are open to all farmers now and in the future.

How could gene-edited crops be grown alongside conventional and organic crops?

If there end up being separate markets for crops and livestock based on the breeding technique used to produce them, this would be managed in the same way as it is currently. Coexistence, identity preservation and sales based on varieties or breeds are an established part of farming now, as well as the separate market for organic produce. The same principles and logistics would apply with gene edited products if the market demands it.

How will supply chains be able to identify and differentiate gene-edited varieties?

Transparency and openness are essential as these new breeding techniques are developed and used. However, there is no scientific basis for statutory segregation or labelling in terms of safety or detection for GE products where genetic changes could have occurred through conventional breeding. Indeed, there is a risk that consumers would be misled if GE was labelled on foods at point of sale.

The NFU is fully supportive of a transparency or notification proposal developed through the cross-party All Party Parliamentary Group on Science and Technology in Agriculture. This would involve declaration by breeders if gene editing has been used, complementing existing registration and verification requirements. It would facilitate choice within supply chains if there was market demand for differentiation in the future. Discussions are ongoing about how this could be implemented in practice.

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