Risk Assessment

The objective of risk assessment, under the Cartagena Protocol on Biosafety, is to identify and evaluate the potential adverse effects of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. Risk assessment is used by competent authorities to make informed decisions regarding living modified organisms.

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 associated with LMOs should be considered in the context of risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment; and
• Risks assessment should be carried out on a case-by-case basis.

According to the methodology described in Annex III of the Protocol, risk assessment entails the following steps:

• Identification of any novel genotypic and phenotypic characteristics associated with the LMO that may have adverse effects on biological diversity in the likely potential receiving environment (taking also into account risks to human health);
• Evaluation of likelihood of these adverse effects being realized (taking into account the level and kind of exposure of the likely potential receiving environment to the LMO);
• An evaluation of the consequences should these adverse effects be realized;
• An estimation of the overall risk posed by the LMO; and
• A recommendation as to whether or not the risks are acceptable or manageable (including, where necessary, identification of strategies to manage these risks).

Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the LMO in the receiving environment.