Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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FSA News Item, 21 September 2023
A summary of the Board's discussion on the regulation of precision breeding.
Note: For a copy of the paper under discussion, see the previous news item on this topic: 7 September 2023
The Food Standards Agency Board met yesterday 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.
Further information
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.
