The Precision Breeding Act: the next steps for gene-edited foods

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The conference will examine next steps for gene-edited foods in England, with a particular focus on policy and regulation in light of the passing of the Genetic Technology (Precision Breeding) Act in 2023 (the Precision Breeding Act). 

Katrina’s analysis will compare the UK approach against the EU’s proposals, consider the position of Scotland and Wales and assess concerns expressed within the industry.

What is precision breeding?

Precision breeding involves altering the DNA of plants or animals through sophisticated techniques such as gene-editing. These changes to the organism’s DNA must be equivalent to what can be achieved using traditional breeding methods.  This distinguishes precision bred organisms (PBOs) from genetically modified organisms (GMOs), which are altered in a way that would not occur naturally. 

The Precision Breeding Act enables PBOs to be taken outside the scope of existing novel foods regulation, so that PBOs are not classed as novel foods. Rather, the Food Standards Agency has been empowered to create a new regulatory regime for bringing foods containing PBOs to market. On the advice of the Advisory Committee on Novel Foods and Processes (ACNFP), the FSA is proposing to create a series of triage questions loosely based on the novel foods regime which would assign PBOs to a Tier. Tier 1 PBOs would proceed to authorisation and be placed on the public register with minimal additional scrutiny. In contrast, Tier 2 PBOs would be subject to a case-by-case review.

UK vs EU

The EU’s plans are currently under development. As currently drafted, they would structure the regime in a broadly similar way to the Food Standards Agency’s proposals; a two-tier categorised system and a public register are at the centre of both approaches. However, there are differences in the language and detail, and it is important to note that the EU proposals could still change significantly as a result of trilogue negotiations between the EU institutions.

Scotland, Wales and Northern Ireland: the impact of the Internal Market Act

It is important to be aware that the Precision Breeding Act only applies to activity in England as the regulation of genetic technologies for food is a devolved matter. However, the United Kingdom Internal Market Act 2020 potentially means that precision bred products that have been legally marketed in one nation may also be marketed in the other UK nations. There is some legal uncertainty around this, particularly if a food containing PBOs is subject to further processing. 

The Scottish Government has expressed opposition to the Precision Breeding Act, stating in open letters that it is "wholly opposed" to what it means for the exercise of its devolved powers within this policy area. Both the Scottish and Welsh Parliaments have expressed concerns about the prospect of precision bred products not requiring consumer labelling.

The need for clear regulatory pathways

The Precision Breeding Act has the potential to support companies in bringing ground-breaking foods to market. Precision breeding has the potential to make significant leaps forward in relation to food sustainability, achieving net zero and health. For example, this technology could enable crops which are more resistant to climate change to be developed, or bring to market products made from crops designed to be healthier to eat. 

For companies to invest, however, there needs to be a clear regulatory route to market for the resulting foods. So the FSA’s framework for positive regulation of sophisticated gene editing technologies is very welcome, as are the EU proposals setting out a similar pathway. Concerns from the devolved nations and some industry groups, however, currently present difficulties for the smooth implementation of these measures.