At the UK Food Standards Agency (FSA) board meeting on September 20, 2023, decisions were made about certain aspects of the new process to regulate the use of precision-bred organisms (PBOs) intended for food and feed. A detailed proposal will be published for public consultation once agreement is reached among the board on its approach to PBO regulation, before FSA delivers official advice to UK ministers.
Precision breeding covers plants and animals developed using modern biotechnology, such as gene editing, but where the genetic changes could have occurred through traditional breeding methods.
FSA’s science Advisory Committee on Novel Foods and Processes do not believe that PBOs present new risks when compared to traditionally bred organisms used in food and feed. However, because the technology is new and constantly developing, FSA finds it necessary to introduce regulation to provide oversight and safeguards for public health. The board and FSA Chair wish to see an authorization process that could accommodate the types of applications that may come through the system in the future, and is flexible enough to respond to future scientific developments and keep pace with innovation.
The vision for the approach to regulation is two-tiered, encompassing Tier 1 applications with minor changes that might mirror those from traditional breeding and Tier 2 applications where the changes could significantly alter the nature or composition of the consumed product. The board agreed that Tier 1 applications should be notified to FSA so they can be included on the public register, however, there was debate on the extent of data that would be required as part of the notification process.
Additionally, the board agreed that food businesses should be responsible for understanding their legal obligations and ensuring that products are submitted for authorization under the correct process. For FSA to authorize Tier 1 PBOs, businesses must notify FSA if their product is a lower-risk PBO befitting Tier 1 using criteria set by FSA. 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 FSA can check that businesses fully consider the evidence to correctly identify Tier 1 products.
The board also supported proposals for an enhanced public register of PBOs to provide information to consumers, to aid external scrutiny, and to allow monitoring of the evolution of PBOs in the market.
The board emphasized that businesses must be able to keep track of PBOs used in their products, encouraging discussion with stakeholders who express concerns. The chair noted specific questions raised by the organic sector and recommended that officials have additional conversations with these stakeholders. Some members raised concerns about enforcement, specifically, that criminal sanctions are not available under the act.The act is relevant to England only, but is expected to affect the rest of the UK devolved nations. 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.