Yesterday (Wednesday 20 September 2023), the Food Standards Agency board decided on their preferred approach for the authorisation route for precision bred food and feed in the UK. This approach marks a change from full GM authorisation for certain precision bred organisms; allowing a ‘notification’ system instead of a full FSA risk assessment for precision bred products that contain minor changes which might mirror those arising from traditional breeding.
The term “precision breeding” is used to encompass technologies such as gene editing using CRISPR/Cas systems that allow targeted genetic changes to the genome of an organism that could have been produced through traditional breeding methods, i.e. without introduction of heterologous genetic material into the host.
In the UK, the Genetic Technology (Precision Breeding) Bill was approved by both Houses of Parliament and became an Act in March 2023. Importantly, this Act sets out that organisms produced by precision breeding will no longer be considered to be genetically modified organisms (GMOs), as they were previously defined under European Union (EU) law. A change in how these organisms are defined may seem somewhat academic, but the practical consequences for plant breeders and the plant biotechnology industry in the UK are significant.
The UK still has some of the strictest regulations on GMOs in the World, borne out of a disproportionate focus on how a plant was produced, rather than the benefits and risks of the traits that it delivers. Until recently, the treatment of precision gene edited crops as GMOs (thereby limiting their planting and sale too), rather than as a technological refinement of traditional mutagenic methods, meant that innovators in the UK were faced with prohibitively stringent regulations to bring a new crop to market which would not have applied if the same crop had been produced by a “conventional” classical breeding approach. Now, providing the resulting crop could have been produced by traditional breeding methods, the regulations applying to GMOs will not apply.
In the UK, the self-determination system will allow applicants to describe why the genetic change was made and any implications to food safety and quality. Products that fall within a species with a history of safe consumption as a food or feed and where no particular safety concerns such as nutritional disadvantage, toxicity or allergenicity are raised, may proceed to authorisation solely on this basis. Detailed proposals will be subject to public consultation in November, however if approved, this streamlined process could benefit innovators by reducing the administrative cost and time associated with approval of new gene-edited products. Hopefully, this will result in greater numbers of new crops coming to market to meet demands such as a rapidly changing climate and will enable innovative SMEs and research institutes to commercialise their new crops.
Things may be changing in Europe too. At present, whilst transgenic plants, plants produced by gene-editing techniques and the biotechnological methods of producing them are patentable (unlike conventionally bred plants), the current European regulatory regime is not conducive to bringing these products to market. However, a recent EU ruling allowing organisms obtained by in-vitro random mutagenesis, which is a less targeted approach than gene-editing, suggests that long-awaited change may be on the horizon and that Europe may finally be catching up with more forward-thinking regulators elsewhere, such as the US Department of Agriculture and others in South America who have chosen to adopt more permissive regulations.
This is good news for consumers and the environment, as plant breeders can utilise precision gene-editing techniques such as CRISPR to develop crops to meeting pressing humanitarian and environmental challenges. It also opens up a new market for gene-edited crops, and highlights the importance of protecting related IP in Europe and the UK.
Ben is a senior associate and patent attorney at Mewburn Ellis. He does patent work in the life sciences sector. This includes drafting and prosecuting UK, European and International patent applications. The majority of Ben's practice is engaged in 'defending' or 'attacking' patents in opposition and appeal proceedings before the EPO. Ben has a first class honours degree from the University of Manchester, where he won the prize for highest-placed student in his year for biological sciences. He won a Sainsbury-sponsored undergraduate scholarship to the University of Cambridge to investigate plant molecular markers for climate change, and completed an undergraduate research placement at the Royal Botanic Gardens, Kew. He has a Sainsbury-sponsored PhD from the University of Cambridge, specialising in plant molecular genetics.
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