In March 2023, the Genetic Technology (Precision Breeding) Act became law in England. The legislation provides for the creation of a new regulatory framework in England for the premarket authorization of PBOs for use in food and animal feed and its enforcement.

FSA has set out proposals for the new framework in the recently launched public consultation, and is seeking feedback from stakeholders. The Precision Breeding Act applies to England only, as will all secondary legislation. However, responses from interested parties across the entire UK are welcomed, as there are implications for the other UK nations as set out in the consultation due to the operation of the UK Internal Market Act 2020 and the Windsor Framework.

The Proposed Framework

The newly proposed regulatory framework for premarket authorization of PBOs for food and feed comprises:

• A premarket authorization system, based on independent scientific advice, designed around the classification of PBOs into two tiers
• A public register of PBOs for food and feed that have received marketing authorizations
• Provisions for enforcement of requirements under the new framework.

A PBO for food or feed will only be considered under the proposed framework if its PBO status has already been determined by the UK Department for Environment, Food, and Rural Affairs (Defra) Secretary of State, informed by the advice of the Advisory Committee on Releases to the Environment (ACRE), or if it is the qualifying progeny of a marketable PBO.

FSA commissioned its Advisory Committee on Novel Foods and Processes (ACNFP) to provide advice on the current scientific understanding of the technologies used in precision breeding to support the development of a regulatory approach. ACNFP advised that it did not find any evidence that PBOs are intrinsically more hazardous than traditionally bred organisms (TBOs), while at the same time recognizing that a range of outcomes are possible from the rapidly developing technology. Therefore, the committee recommended a two-tier approach to allow for a proportionate review of PBOs where food or feed safety could be impacted. The two tiers are as follows:

1. Tier 1: PBOs that are very similar to TBOs, for which potential safety risks are understood, do not warrant a bespoke safety assessment and will be allowed a simpler route to market.
2. Tier 2: PBOs with traits where further analysis of the data is required, specifically including novel goods or PBOs that have compositional changes that could affect toxicity, allergenicity, nutritional quality or other safety concerns where potential food and feed safety risks need further consideration. Tier 2 PBOs will require be a bespoke safety assessment process, including a more detailed examination of the characteristics of the PBO.

ACNFP also recommended two different models for data requirements requested by FSA when conducting safety assessments of PBOs for food and feed. Both Model 1 and Model 2 would require information about:

• The nature and purpose of the genetic change
• The methods used to make the change
• The analysis or procedures undertaken to minimize the potential for unintended alteration of the organism’s genetic material (also called “off-target effects”)
• Identification of parts intended for use as food and feed and intended uses
• The history of safe use for food and feed of the relevant species
• The predicted impact of change on composition and allergenicity
• Consideration of known hazards for the species that are managed by developers as part of due diligence, for example, anti-nutritional factors, toxins, and allergens.

The main difference between Model 1 and Model 2 relates to the amount of compositional data considered to determine tier status. Model 1 would require a largely descriptive assessment of potential safety risks associated with the intended genetic change, including initial data to ensure the intended compositional change (where relevant to the quality or safety of food/feed) has been achieved. Information on how the intended change has occurred and the likely occurrence of food/feed safety concerns would also need to be provided. In addition to the information and data required in Model 1, Model 2 would require additional routine data on composition would also be required (e.g., for nutrients/anti-nutrients, toxicology, and allergenicity as necessary), providing a higher level of safety assurance.

FSA proposes to adopt the data requirements and criteria for determining the tier status of PBOs at triage stage of ACNFP’s proposed Model 1.

Tier 1 PBOs for food and feed would require notification to FSA. At the triage stage, developers would apply ACNFP criteria and notify the FSA of PBOs for food and feed falling within Tier 1, according to the criteria. FSA would acknowledge receipt of the notification and recommend to the Secretary of State that the PBO be authorized for use in food and feed, after which developers of a Tier 1 PBO granted a food and feed marketing authorization would receive a communication from FSA and FSA would place the PBO on the public register.

Tier 2 PBOs for food and feed would require an application to FSA as with other regulated products. At the triage stage, developers would apply ACNFP criteria and would be required to submit an application with:

• Data as required by ACNFP’s proposed Model 1 demonstrating how Tier 2 status was determined
• Any additionally identified data that may be required for bespoke risk assessment relevant to the factors determining the PBO as Tier 2 (i.e., novelty, composition, or other concerns).

FSA would then carry out a bespoke risk assessment followed by risk management in accordance with its risk analysis process. Following completion of this process FSA would recommend to the Secretary of State that the PBO should be authorized (with or without conditions of use) or not authorized for use in food/feed. Developers of a Tier 2 PBO granted a food/feed marketing authorization would receive a communication from the FSA about the decision and FSA would place the PBO on the public register if approved.