United Kingdom - Discussion on Precision Breeding at the FSA Board meeting on 20 September 2023

The Food Standards Agency Board met on 20 September 2023 to discuss and decide on aspects of the new process to regulate the use of precision bred organisms (PBOs) for use in food and feed. Following agreement on the Board's preferred approach, detailed proposals will be subject to public consultation before the FSA formally provides advice to Ministers.

Speaking on the paper, Professor Susan Jebb, Chair of the FSA said:

″We are developing a system which will allow us to provide sufficient scrutiny, so we can be confident that precision bred products that make it through the authorisation process are safe for people to eat.″   

Professor Jebb explained that advice from the FSA’s science Advisory Committee on Novel Foods and Processes (ACNFP) suggested that PBOs present no inherent additional risk when compared to traditionally bred organisms. However, because the technology is new and constantly developing, the FSA believes it necessary to introduce regulation to provide oversight and safeguards for public health.

The Board were keen to see an authorisation process that could accommodate the types of applications that may come through the system in the future. The Chair noted that the new system should be sufficiently flexible to respond to future scientific developments and agile enough to keep pace with innovation.

The two-tiered approach to regulation would encompass applications with minor changes that might mirror those from traditional breeding (Tier 1), and those where the changes could significantly alter the nature or composition of the consumed product (Tier 2).   

The Board considered the proposed approach and agreed that Tier 1 applications should be notified to the FSA so they can be included on the public register. There was some debate on the extent of data that would need to be provided as part of the notification process and the Board asked for further work on this aspect.  

It was agreed that, just as for other food authorisation regimes, the food business should be responsible for understanding their legal obligations and ensuring that products are submitted for authorisation under the correct process.  For PBOs, businesses must notify the FSA if their product is a lower-risk, Tier 1 PBO, using criteria set by the FSA. The FSA will then authorise the product.  Tier 2 PBOs, which may be higher risk, must go through an FSA risk assessment. In all cases, businesses must have the necessary information and evidence to understand any safety risks. The Board asked officials to provide more detail about how the FSA can check that businesses have correctly identified Tier 1 products and properly considered the evidence.  

The Board also supported proposals for an enhanced public register of PBOs to provide as much information as is reasonable and useful to consumers, to aid external scrutiny and allow monitoring of the evolution of PBOs in the market.

They emphasised that businesses need to be able to keep track of the PBOs that they were using in their products, encouraging discussion with stakeholders who had expressed concerns. The Chair noted specific questions raised by the organic sector on this subject and recommended that officials have additional conversations with these stakeholders. Some members raised concerns about enforcement, in particular that civil sanctions may not be adequate to deter businesses from breaching food law in this area, noting that criminal sanctions are not available under this Act.

Professor Susan Jebb said:

″This topic has attracted considerable external interest and we will continue to engage formally and informally with stakeholders so that we really try to understand perspectives, and that will inform the way this process develops.

This is an England only act, but it will impact the devolved countries and we continue to maintain regular dialogue across the four nations.″   

Reflecting on the discussion, the Chair concluded:

″This is a complex area and an important moment for the FSA in thinking about our role and responsibilities in the food system. We need to develop a proportionate way of authorising precision bred organisms in food and feed that is both responsive to developments in science technology and that protects consumers.″

The FSA expects to launch a formal public consultation in November, to give consumers, enforcement authorities, and industry the chance to provide written comments on draft proposals and legislation.

All Board papers from this week's meeting can be viewed on the FSA website. You can also watch the full video recording of the meeting by visiting the FSA's YouTube channel.

The next FSA Board meeting will take place in Bristol on 13 December 2023.

BSPB: Plant Breeders welcome positive progress towards precision bred food and feed approval process

The British Society of Plant Breeders (BSPB) has welcomed proposals considered by the Food Standards Agency Board on 20 September for a streamlined approach to the regulation of precision bred food and feed products under the Genetic Technology (Precision Breeding) Act 2023.

BSPB said the approach recommended by the FSA follows the science and could unlock significant investment and economic activity in the use of precision breeding techniques. By accelerating the development of improved crop varieties, more precise breeding technologies such as CRISPR/Cas gene editing will help plant breeders keep pace with demands for increased agricultural productivity, resource-use efficiency, more durable pest and disease resistance, improved nutrition and resilience to climate change.

Mirroring the regulatory process already adopted in Canada, and the approach recently proposed in the EU, the FSA is recommending a move away from the lengthy regulated products process currently applied to GMOs, novel foods and irradiated foods, opting instead for a more streamlined process for Precision Bred Organisms (PBOs), more proportionate to the scientific evidence of risk.

This is in line with expert scientific advice from the Advisory Committee on Novel Foods and Processes (ACNFP) that there is ‘no evidence that PBOs are intrinsically more hazardous than traditionally bred organisms (TBOs)’and is consistent with the definition set out in the Precision Breeding Act that confirmed PBOs contain genetic changes which could have occurred in nature or through conventional breeding.

Commenting on the FSA recommendations, BSPB chairman Robin Wood said:

″The plans unveiled at today’s Board meeting confirm the adoption of a more proportionate, science-based approach to approving precision bred products for marketing as food and feed. Until very recently, there were serious concerns that the FSA was planning to require separate risk assessment, expert committee scrutiny, public consultation, approval by both Houses of Parliament and Secretary of State sign off for each and every precision bred product. This would have been entirely disproportionate to the scientific evidence of risk, and out of line with the underpinning rationale of the Act that precision bred products are no different from conventionally bred. This more streamlined approach is likely to encourage interest and investment from plant breeding businesses of all sizes, across a wide range of crops and traits, which is fantastic news.″

Under arrangements currently planned to be presented to Parliament in summer 2024, and entering into force at the end of 2024, the streamlined FSA approach would give applicants responsibility for undertaking initial triage and determining whether a PBO should be regulated as Tier 1 or Tier 2, subject to technical guidance.

Tier 1 products are defined by FSA as very similar to traditionally bred products, which consumers are familiar with and for which potential safety risks are understood. Tier 2 products are defined by FSA as novel foods or PBOs with compositional changes which could affect toxicity or allergenicity, or other potential safety concerns. These PBO products would be subject to case-by-case risk assessment.

The vast majority of PBOs are expected to be classified as Tier 1. For these PBOs, the FSA’s recommended approach would require applicants to notify FSA of the Tier 1 determination, providing details of the nature and purpose of the genetic change(s) introduced using precision breeding. A public register would be maintained by FSA providing information about notified PBOs.

Once authorised for food and feed marketing, precision bred crop varieties would continue to be subject to existing statutory variety registration and seed certification requirements prior to marketing as seed or propagating material.

Mr Wood reiterated BSPB’s commitment to transparency through the development of a public register of precision-bred varieties:

″Plant breeders fully support transparency. Last year BSPB wrote to the Defra Minister responsible, Rt Hon Mark Spencer MP, to reiterate the Society’s commitment to maintain a public register of all precision-bred plant varieties approved for sale in the UK, so enabling choice and openness of information within the supply chain. We recognise that this will be an important resource for farmers who do not wish to grow precision bred varieties, such as registered organic farmers who are currently prohibited by law from doing so.″

Mr Wood also called for clarity from the devolved administrations in Scotland and Wales over UK-wide regulation of precision bred products:

″The recommendations considered at today’s FSA Board indicate that regulatory arrangements in England will be very similar those proposed in the EU, with no separate requirements for food and feed marketing of precision bred products considered to be equivalent to their conventionally bred counterparts. While the Scottish and Welsh governments have previously opposed the Precision Breeding Act, indicating their preference to remain aligned with the EU, they have remained tight-lipped over their plans since the EU’s deregulatory proposals were published in July. To deliver a harmonised UK-wide approach, we would urge both devolved administrations to provide clarity sooner rather than later on how they plan to move forward on this issue.″

NIAB: New approach to regulating precision bred products could unlock investment in crop genetic research and innovation

NIAB welcomes the progress made at the Food Standards Agency (FSA) Board meeting, which paves the way for a more streamlined and evidence-based approach to regulating food and feed products developed using new precision breeding techniques such as gene editing.

As a result, England could be on course to adopt one of the most progressive and enabling regulatory systems for gene edited products in the world, opening up significant potential for increased inward investment and international research collaboration.

The proposals discussed by the FSA Board on 20 September, which are intended to be brought forward as secondary legislation under the Genetic Technology (Precision Breeding) Act, are similar to the regulatory approach adopted earlier this year by Canada, and recently proposed by the European Union, in not requiring separate risk assessment, traceability or labelling of precision bred products considered to be equivalent to their conventionally bred counterparts.    

Commenting on the plans discussed at the FSA Board meeting, NIAB chief executive Professor Mario Caccamo said:

″It is difficult to over-state the significance of these technologies for crop genetic research and innovation in this country. By adopting one of the most progressive and enabling regulatory systems for gene edited products in the world, and with such an internationally recognised research base in plant genetic science, England could genuinely be on course to become one of the best places globally to invest in agri-food research and innovation."

"NIAB is already in discissions with a number of gene editing companies and scientific partners internationally regarding potential research collaborations. The positive direction of travel considered at the FSA Board meeting can only serve to strengthen those opportunities.″

Professor Caccamo pointed to the advances already made in precision breeding research since simplified arrangements for experimental field trials were introduced in March 2022:

″Since new, simplified arrangements were introduced in March last year for outdoor trials of gene edited plants, nine new field trials have been notified in England, twice as many as for the whole of the EU over the same period. The focus in each case is on using new precision breeding techniques to make our farming systems more sustainable, whether in terms of reducing food waste (pod-shatter resistant oilseed rape, non-browning potatoes), reducing pesticide use (late blight resistance in potatoes), healthier eating (Omega-3 enriched camelina, tomatoes higher in provitamin B3), or safer food (low-asparagine wheat).″   

″As each of these examples demonstrate, precision breeding techniques such as gene editing open up major opportunities to improve our food system through scientific innovation. It is encouraging that the Food Standards Agency are listening to the science, and recognise the enormous potential to deliver on their policy aims to make our food supply healthier, safer and more sustainable,″ said Professor Caccamo.