The UK parliament has signed into law rules for its Precision Breeding Act (2023), bringing the sale of gene-edited products to consumers closer. However, the new law applies to England only.
Precision breeding refers to altering an animal’s or plant’s DNA using specialised enzymes to change its genome at specific points; the modification must be possible using traditional breeding to qualify. They do not apply in cases where genes are transferred from unrelated species – deemed genetically modified organisms (GMO).
The regulations, approved in May, had been put before the parliament in February to bring into operation the Genetic Technology (Precision Breeding) Act, which had been passed by the last government in March 2023, for plants. ‘We had been waiting some time for this secondary legislation. It was probably slowed because we had a change of government,’ says Cathie Martin, a plant scientist at the John Innes Centre, UK.
New rules
The new rules make it easier for researchers to develop and commercialise genetically-edited plants. They should clear a path to crops with enhanced resistance to diseases and pests or greater resilience to drought or waterlogging.
Martin is hoping that it will speed up the approval of tomatoes for UK supermarket shelves that she edited to be enriched in vitamin D. UK crop scientists such as Peter Eastmond at Rothamsted Research, who developed a barley with high lipid content to cut down greenhouse gas emission from cattle, welcomed the enabling legislation, noting that it is set to be in place by the end of 2025.
Animals are covered by the 2023 act, but were not included in the legislation passed in May. The act itself explicitly states that animal welfare aspects need to be addressed and Defra has commissioned reports on this issue.
‘The technology itself will not cause a new welfare condition or a welfare concern,’ says Bruce Whitelaw, an animal geneticist at the University of Edinburgh. Whitelaw’s team altered a gene in pigs to make them resistant to a virus and the US Food and Drug Administration approved animals with these edits earlier this year.
Researchers suspect that animals came behind crops in the enabling law partly to avoid public opposition and give time for debate on gene-edited livestock. ‘Perhaps equally important from the plant side, there was an immediate demand,’ says Whitelaw. ‘In the animal world, we don’t have that pipeline of products ready for approval.’
Precision-bred crops that are approved in England can be sold in Scotland and Wales, the government has confirmed. However, they cannot be grown or significantly processed in those nations without new legislation from their devolved governments. These products will need to comply with EU law as it applies in Northern Ireland in order to be sold there.
Other countries have also moved forward with updated rules around gene-edited crops. In April, Switzerland released a proposal that would ease barriers on plants developed by newer genome-modifying techniques such as Crispr-Cas9. This would create a distinction between gene editing and genetic engineering using DNA foreign to the plant – such as herbicide resistance genes from bacteria put into some early GMO crops.
EU quagmire
Meanwhile, the EU remains mired in decades-old legislation on this topic. This is the result of a European Court of Justice ruling in 2018 that gene-edited crops are subject to the same 2001 legislation as GMOs. The European Commission has since pushed for a radical rethink of how the EU regulates such crops, concluding that current EU legislation is not fit for purpose and proposing substantial changes.
EU regulations proved extremely onerous for GMOs, and academics and companies in Europe are still reluctant to develop new traits using Crispr-Cas gene editing. ‘European industry cannot plan for the EU market and – more importantly – they cannot do field experiments,’ says Stefan Jansson, a plant researcher at Umea University in Sweden. ‘Europe has now fallen very much behind [in using gene editing for commercial crops].’
The commission subsequently proposed changes to gene-edited plant regulations. The European parliament then voted in February 2024 to have two separate categories for crops obtained using new genomic techniques (NGTs) and GMOs and to begin negotiations with EU member states on introducing new legislation.
This requires a qualified majority from the 27 EU member states. ‘In general, countries to the south are more negative than those in the north,’ says Jansson. Countries such as Hungary and Austria are generally against NGTs; countries such as the Netherlands and the Nordics support new rules; and countries such as Germany and France face strong domestic forces in opposing directions. Getting enough member states, with their own domestic political pressures, onboard is challenging.
There was a fly in the ointment, however. ‘The biggest problem in the text, as amended by parliament, is that they added that NGT plants must be excluded from patentability,’ says Sven Jean Bostyn, a law professor at the University of Copenhagen, Denmark. ‘That came out of the blue and we already have a law that allows for patents on plants, so that poses a legal issue.’
There is, however, now a new parliament with a stronger contingent of populist right-wing parties. Most have not staked out a political position on this issue, notes Bostyn. In May, negotiations were set to begin between the parliament and the Council of the European Union, which has proposed a text without the exclusion of patents for NGTs. It remains to be seen if a new law can be negotiated.
Opposition
There is a push by industry, scientists and the commission to improve the situation for NGTs, although updating the regulations is opposed by European green parties and some environmental groups. ‘Research on NGT plants is disappearing in Europe,’ says Bostyn. ‘China is investing an awful lot of money in NGT techniques and the US has been moving forward too.’
Yet it will be tough for Europe to isolate itself from advances in NGT crops. It could be technically challenging to regulate their import, for example, because distinguishing gene editing from that achieved through regular breeding is almost impossible. ‘If we miss the boat and don’t allow this research, then Europe will become takers of the technology,’ says Bostyn. Previously, the EU compromised in allowing the import of GMO soybean for animal feed.
Ironically, as the commission attempts to move the EU closer to the UK on this issue, negotiations with the UK over trade access could pause the country’s progress on gene-edited crops. Senior EU figures were concerned that any deal ‘does not give UK farmers a competitive or technological advantage’ over their EU counterparts, according to a report in The Times.
A UK parliamentary group on science and technology in agriculture recently sought assurances that the act’s implementation would be exempt from any deal with the EU. ‘It is not yet clear how the exemption might work, or on what terms, particularly as we do not know for certain when the EU will implement its own regulations for new genomic techniques,’ notes Daniel Pearsall, the group coordinator of the parliamentary group.
Mario Caccamo, head of the National Institute of Agriculture Botany, is hopeful that an agreement can be reached with the UK that will allow precision breeding, so long as three concerns can be satisfied: it doesn’t prevent the EU commercialising products in the UK, it doesn’t lower standards and unapproved products will not cross into the EU.
‘I’m optimistic since we don’t have any products yet,’ says Caccamo, ‘and in the early days we will be working with fresh produce that tends to be consumed within a few days of harvesting. That can be managed with the tracking systems we have in place.’
If the European parliament and the council cannot agree a position on NGTs, then the commission can withdraw its proposal and gene-edited crops would remain tied to the 2001 GMO legislation. That could leave countries such as the UK and Switzerland with the unenviable choice of falling further behind the US and China in crop biotech or losing EU market access for some agricultural produce.
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