Statement of the ACNFP on Precision Bred Organisms - July 2023

4. Final considerations

Statement of the Advisory Committee on Novel Foods and Processes (ACNFP) on Precision Bred Organisms (PBOs) - Model options and data requirements for triage and Tier assignment of PBOs - July 2023

Last updated: 07 September 2023

50. The ACNFP is presenting two models of data requirement for triage based on differing interpretations of proportionality required in the Genetic Technology (Precision Breeding) Act 2023. There is a choice to be made by risk managers on balancing the level of safety assurance required with the need to deliver on wider policy goals. This will take account of a range of other legitimate factors. The Models are intended to provide an explanation of the current scientific understanding of the technology and how this could inform the decisions of policymakers.

51. It should be noted that most Members of the ACNFP are content with the two Models 1 and 2 proposed in this statement and consider them to offer a realistic choice of data requirements. However, it should be noted a few would prefer still higher levels of technical data for triage (a Model 3 approach) and a few would tolerate no pre-market assessment (a Model 0 approach). All acknowledged that safety assessment can be undertaken, and risk-based decisions can be made even if there are uncertainties and gaps in data and evidence. It is challenging to achieve a consensus on the data requirements in this new area of science and policymaking. New oversight models like those proposed here are required precisely because there is no definitive international consensus on technical guidance for PBO regulation that could be applied here. The context of the policy goals defined in the 2023 Act of Parliament adds another layer of complexity and such goals are likely to vary from nation to nation. This is a rapidly evolving area in the regulation of food safety that warrants ongoing attention.