This Risk Analysis Framework (RAF) is a key explanatory document that provides guidance on how the Australian Gene Technology Regulator approaches risk analysis of genetically modified organisms (GMOs). The purpose of this document is to: a) provide a guide to the rationale and approach to risk analysis used by the Regulator; b) enable the application of a consistent risk analysis approach to evaluating license applications; c) provide a clear guide to the provisions of the legislation that relate to risk assessment and risk management; and d) ensure that the risk analysis and decision-making processes are transparent to both applicants and the broader community.