New regulatory framework for precision bred food

8th September 2022

The Genetic Technology (Precision Breeding) Bill (the Bill) is currently progressing through the various stages of Parliamentary scrutiny.  The Bill proposes a change to the legal definition of Genetically Modified Organisms (GMOs) which would remove certain organisms produced by precision breeding techniques, such as gene editing, from the scope of GMOs.

Part 3 of the Bill empowers the Food Standard Agency (FSA) to create a regulatory framework for Precision Bred Organisms (PBOs), that is, plants, animals and food and feed products that have been developed using precision breeding technologies. If approved, this framework will form the basis upon which PBOs are to be authorised to be placed on the market in England.

What might the regulatory framework look like?

According to the FSA, the regulatory framework would contain an authorisation process for food and feed products produced using precision breeding technology and will follow five key principles:.

• Safety – as a food and feed safety regulator, the FSA needs to ensure that the regulatory framework reflects its role to ensure products produced using technologies such as precision breeding are safe.
• Transparency – the regulatory framework must be clearly communicated and accessible to consumers and other stakeholders, with stakeholder participation in the development and operation of the framework, maximising open access to information.
• Proportionality – the regulatory framework should allow specific safety issues associated with PBOs to be adequately assessed without the risk of measures that are too stringent (for example, to ensure foods produced through some conventional breeding methods are not drawn into this category).
• Traceability – some edits that are made by precision breeding are identical to those mutations introduced by natural variation and therefore could not be detected by routine testing.  The inability to definitively identify changes arising from gene editing needs to be considered particularly in relation to labelling and enforcement of PBOs.  Any new framework needs to demonstrate the processes by which the product has been developed.
• Building consumer confidence – the regulatory framework must demonstrate that consumer needs and views have been considered.

The FSA is exploring the possibility of a two-tiered approach to the authorisation process. According to the FSA, a two-tier approach would be proportionate to the broad definition of PBOs contained in the Bill, encompassing both minor changes that might typically result from traditional breeding, and the potential for major changes that, while theoretically possible using traditional breeding, could significantly alter the nature or composition of the consumed product.

How might the two-tier system apply to PBOs?

• Tier 1: All applications for precision breeding food and feed authorisations will be screened for similarity to traditionally bred varieties where the risk is understood and not of concern for consumers. This would include products where the genetic change results in food or feed similar to that produced through traditional breeding. These PBOs would be authorised quickly.
• Tier 2: Applications for precision bred food and feed authorisations where the Tier 1 screening does not allow the risk to be understood, will be subject to an additional step. These applications will require a proportionate risk assessment to determine the level of risk for consumers. This would include a PBO in which there is likely to have been a significant change in the composition of the product that is typically eaten. This process will take longer but in most cases should still be much quicker than authorising a novel food or feed.

PBO public register

As with other categories of regulated products, the FSA would publish a register of PBOs authorised for use in food and feed. The register would be available online, in a searchable format that enabled producers, consumers and enforcement officers to check which products were authorised.

What happens next?

The process set out above is still only in draft form and subject to change, with the FSA due to consult on the process to hear stakeholder views. The eventual process that is put in place will depend on the final content of the Bill, and on the outcome of the consultation. If you need any help preparing for the new regulatory regime or with food regulation in general please get in touch with any of the Food and Drink team.