With little progress now expected on the stalled gene editing file at EU level until 2026 at the earliest, plant breeder Nigel Moore says Britain has a golden opportunity to steal a march on our European counterparts, and to deliver on the Government’s vision to make the UK a science and technology superpower. The Precision Breeding Act has attracted strong interest from potential investors and innovators at home and overseas, supported by a trebling of Government funding for translational plant science. But he warns that this precision breeding opportunity could be at risk, due to concerns that provisions in the secondary legislation needed to implement the Act might lead to restrictive GM-style risk assessments and data requirements for precision bred products, and that the timetable for adopting the implementing regulations could be running out of road before a General Election is called. He urges MPs and Peers on all sides to recognise the risks of consigning British agriculture to the slow lane of science and technology, and to press Defra and FSA for fast and effective secondary legislation. Britain can take a genuinely world-leading position in the development and commercialisation of these transformational technologies. As the EU stalls, we must not let that opportunity slip, he argues.  

    

After a genuine sense of optimism that the European Union was moving at pace to adopt a more science-based and enabling approach to the regulation of new genomic techniques (NGT) such as CRISPR gene editing, the political process has seemingly hit the buffers.

 

Last July, the European Commission tabled proposals to treat NGT plants more like conventionally bred plants than GMOs, mirroring the regulatory approach already adopted in many other countries around the world, including Canada, Japan, Australia, USA, Argentina and Brazil.

 

The Commission’s proposals recognised that NGTs could help plant breeders accelerate the development of higher-yielding crop varieties, with improved resistance to pests and diseases, and better able to cope with greater extremes of climate.

 

The urgent need for such innovation was underlined by food security concerns following Russia’s invasion of Ukraine, and the impact of severe drought in southern Europe. Alongside the opportunity to develop hardier crops requiring fewer pesticides (a key objective of the EU’s Farm to Fork Strategy), the political momentum behind a positive resolution on NGTs appeared irresistible.      

  

But hopes of a three-way agreement between the Commission, Council and Parliament are now fading after the Council of Ministers has repeatedly failed to reach a common position on the Commission’s proposals, while MEPs voted in February to ban the use of patenting in gene edited plants – effectively torpedoing the incentive for innovators to invest. 

 

With the European Parliament elections fast approaching (6-9 June 2024), and the Belgian presidency of the EU Council shortly due to hand over to Hungary (1 July 2024), it is unlikely that any progress on the NGT dossier will be made in the foreseeable future. The Hungarian government is staunchly opposed to both GMOs and NGTs, and their six-month presidency will be followed in January 2025 by Poland, another member state openly hostile to the Commission’s NGT proposals.

 

By the time Denmark takes over the EU presidency in mid-2025, it is widely anticipated that any further progress on the NGT dossier will be put on hold until a Commission study into the patenting issue, due to report on its findings ‘by 2026’, is published.

 

These delays in the EU process, likely to be complicated by the need to reach political agreement with a new intake of MEPs, present a golden opportunity for Britain to steal a march on our European counterparts, and for the Government to deliver on its vision to make the UK a science and technology superpower by 2030. 

 

The ingredients to achieve this are falling into place, at least in relation to England.

 

Primary legislation giving Ministers the powers to remove precision bred (PB) crops from the scope of restrictive GMO legislation was enacted in March 2023. The Genetic Technology (Precision Breeding) Act 2023 passed smoothly through both Houses of Parliament virtually without amendment. And Ministers have certainly not been slow to cite the Precision Breeding Act as a flagship example of the UK using its new regulatory freedoms outside the EU to pursue a more progressive, science-based approach.

 

Defra has also established a new Ministerial working group – bringing together plant breeders, farmers, food manufacturers and retailers – with a remit to get PB products from farms to the supermarket shelves.

 

As a result, there is already strong interest in Britain as a target market for PB products, not only for UK-based research and plant breeding innovation, but also for inward investment. For example, three US companies, J R Simplot Co., Pairwise and Cibus, have all discussed plans to bring gene edited crops to the market in England. Potential applications range from longer-flowering strawberry plants which yield five times as much fruit as their non-edited counterparts, to baby potatoes with ‘bunched’ root architecture which allow almost three times as many tubers to be produced from the same area of farmland, and pod-shatter resistant oilseed rape varieties which help minimise harvest losses and reduce the need for volunteer weed control in subsequent seasons.

         

Ministers also deserve credit for more than trebling Government funding for the Genetic Improvement Networks (GINs), as a key mechanism for translating new genetic knowledge into traits and breeding material suitable for commercial application. This follows longstanding calls from UK scientists and breeders for more joined up R&D policies to bridge a long-recognised gap between early-stage genetic research and its application in commercial breeding programmes. The increase in funding of the GINs from £4.5m to £15m over five years is still not enough, but it is a step in the right direction, and signals a welcome recognition that genetic innovation is a key driver of productivity and sustainability gains in agriculture.

 

But there is a potential blot on the landscape.

 

As it stands, the Precision Breeding Act only provides a framework of ministerial powers. Without more detailed implementing regulations, it remains an empty shell. The Government has signalled its intention ‘in 2024’ to bring forward the secondary legislation needed to implement the Act and allow the development and sale of precision bred products, but concerns over this are mounting on two fronts. 

 

Firstly, the draft implementing regulations already notified to the World Trade Organisation (WTO) in April have reignited fears among prospective developers and investors that despite the underpinning scientific rationale of the Precision Breeding Act that PB products could equally have been created using conventional breeding methods, and therefore pose no greater risks, the draft text as it currently stands could still pave the way for additional, potentially open-ended risk assessments and data requirements for the authorisation of PB food and feed products.

 

The requirements for the Secretary of State to be satisfied that PB products “will not have adverse effects on animal or human health” or that the production of any such food or feed “will not have adverse effects on the environment” are frighteningly absolute – indeed worse than the precautionary principle because it is impossible for the Secretary of State to conclude that any product is 100% safe for all consumers. How might a conventional wheat variety fare against such a requirement, given its known gluten content and the potential ill-effects for coeliac sufferers? Or potentially toxic glycoalkaloids in potatoes, or lectins in red kidney beans?

 

No responsible regulator should entertain such absolute language without proper contextualisation, for example to make clear that the Secretary of State should be satisfied that PB products will pose no greater risks to human or animal health or the environment than their conventionally bred counterparts, or alternatively simply by inserting the term ‘unreasonable’ before adverse effects to qualify the requirement.    

 

Despite the Food Standards Agency’s assurances that it plans to operate a light-touch notification process for Tier 1 precision bred products, the draft implementing rules as they stand open the door to legal challenge by opponents, and to the possible introduction of GMO-style risk assessments under a future administration. This will certainly be focusing the minds of potential applicants.  

         

Secondly, there are serious concerns that the current Government’s precision breeding journey may simply be running out of road. The WTO notification referred to above indicates that the UK Government plans to lay the implementing regulations in July 2024. The average time required for ‘affirmative procedure’ secondary legislation such as this, according to the UK Parliament website, is six to seven weeks. Taking into account the summer recess starting on 23 July, and amid expectations that the Prime Minister will call a General Election at some point in the autumn – with Parliament dissolved six weeks beforehand – this leaves precious little time for the secondary legislation to complete its Parliamentary scrutiny. It is certainly an incredibly tight timetable for such a flagship piece of legislation.

 

This runs a serious risk that the secondary legislation could fail, and the task of bringing forward new implementing regulations will fall to the next administration.

 

This in turn could mean further uncertainty. A prospective Labour Government may instinctively seek greater alignment with the EU timetable and process, bringing further delays.                

 

And many of us remember with some trepidation the final words of shadow farming minister, Daniel Zeichner MP, as the Precision Breeding Bill completed its passage through the House of Commons. Having pressed for mandatory labelling and traceability, additional risk assessments and public good criteria, and the creation of an over-arching Genetic Technology Authority, he signed off ominously: “That is unfinished business, and it is for another day.”

 

I very much hope that was rather a political remark for the purposes of opposition than a statement of intent, but I would urge MPs and Peers on all sides to recognise the risks of consigning Britain to the slow lane of science and technology where food, agriculture and the environment are concerned, and to press Defra and FSA for fast and effective secondary legislation.

 

Britain can take a genuinely world-leading position in the development and commercialisation of these transformational technologies. As the EU stalls, we must not let that opportunity slip. 

 

Nigel Moore is a plant scientist with formal education in plant physiology, genetics and agronomy. He has worked in private sector plant breeding research and seeds for over 35 years.  Nigel is employed by the seed company KWS as global head of business development and strategy for cereals crops. He is a former chair of the British Society of Plant Breeders (BSPB) and past President of Euroseeds, the European plant breeding and seeds organisation. He is a member of the Science for Sustainable Agriculture advisory group.