Box 1 ERA of GMOs

ERA involves a technical assessment of biosafety: the safe handling, transport and use of living modified organisms (LMOs, alternatively known as Genetically Modified Organisms (GMOs)) resulting from biotechnology that may have adverse effects on biological diversity, also taking into account risks to human health. ERA is a process to identify significant risks to the environment and health, estimating their magnitude and likelihood and defining any risk management that may be required. The fundamental features of ERA are consistent across different global jurisdictions [7, 8, 11,12,13,14] and consist of four key stages:

I.Problem formulation allows the identification of potential adverse effects (hazards) associated with the GMO. It is a systematic way of structuring the ERA at this first stage by establishing the policy context and scope via the identification of protection goals, aspects of the environment and health that are considered to be of value in the jurisdiction where the intervention is being considered and so are identified from a combination of policy, legislative, regulatory, and community priorities. These protection goals are then used to consider a broad array of potential harms from the intervention in a highly iterative, systematic approach involving a diverse range of expert input. Based on scientific evidence and data specific to the intervention, the plausibility of each potential harm to protection goals is investigated via the development of a pathway to potential harm in which the causal chain of events that would be required for that potential harm to occur is defined. Next, risk hypotheses are developed to interrogate key individual steps in that pathway. Then, an analysis plan is constructed describing the measurement endpoints to test each of the risk hypotheses, as well as other potential sources of data that might reduce aspects of uncertainty in a given pathway

II.Exposure Characterization identifies the likelihood that potential harms occur from identified routes of exposure

III.Hazard Characterization establishes the magnitude and type of harm that might be caused if it were to occur

IV.Risk Characterization allows determination of the overall level of risk, taking into account both exposure and hazard characterization, in order to facilitate decision-making about risk mitigation, risk management and risk communication