A risk assessor may identify the need for a strategy to monitor the receiving environment for adverse effects that may arise after the introduction of the LMO and include it as part of the recommendations for the Competent National Authority(ies). This may happen, for instance, when the level of uncertainty could affect the overall conclusions of the risk assessment. Moreover, some biosafety frameworks may have a policy to request a plan for monitoring as part of the risk assessment of all or particular types of LMOs.
Monitoring after the release of the LMO aims at detecting changes (e.g. in the receiving environment(s) or in the LMO) that could lead to adverse effects.
Monitoring strategies may be designed on the basis of the protection goals identified by national legislation and regulation, if available, and parameters that are relevant to the indication of any increasing risk to the assessment endpoints in a “top-down” approach, or on the basis of specific risks in a “bottom-up” approach.
