UK FSA Plans for Simplified Regulation of Gene Edited Crops
On 20 September, the UK Food Standards Agency (FSA) presented its recommendations to the FSA Board for a simplified approach to regulating the placing on the market of food and feed products developed using precision breeding techniques such as gene editing, under the terms of the Genetic Technology (Precision Breeding) Act 2023. Please see this press release from the FSA on the matter.
FSA is planning 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 PBOs contain genetic changes which could have occurred in nature or through conventional breeding.
Under arrangements set to be presented to the UK Parliament in the summer of 2024, and entering into force at the end of 2024, the simplified 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. Under the FSA’s revised proposals, 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, applicants would be required to notify FSA of the Tier 1 determination, alongside information such as a description 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.