The Biosafety Protocol requires Parties to make decisions on import of LMOs for intentional introduction into the environment in accordance with scientifically sound risk assessments (
Article 15). It sets out, in
Annex III general principles, methodological steps, and points to consider in the conduct of risk assessment.
The general principles include, among others, the following concepts: Risk assessment should be carried out in a scientifically sound and transparent manner; Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk; Risks should be considered in the context of risks posed by the non-modified recipients or parental organisms; and that Risks should be assessed on a case-by-base basis.
The methodology described in Annex III of the Protocol follows the conventional risk assessment paradigm, beginning with identification of a potential hazard, such as characteristics of an LMO, which may have an adverse effect on biodiversity. Risks are then characterized based on combined evaluation of the likelihood of adverse effects, and the consequences should those effects be realized.
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