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.
The Protocol, in
Article 16, requires Parties to adopt measures and strategies for preventing adverse effects and for managing and controlling risks identified by risk assessments (Articles 16.1 and 16.2). Parties are also required to take measures to prevent unintentional transboundary movements (Article 16.3); to ensure that LMOs undergo appropriate periods of observation prior to use (Article 16.4); and to cooperate in identifying LMOs and their traits that may pose risks, and in taking appropriate management measures (Article 16.5).
At its second meeting, COP-MOP considered risk assessment and risk management for the first time and adopted
decision BS-II/9. In that decision, the Executive Secretary was requested to convene, prior to the fourth meeting of the COP-MOP and subject to availability of financial resources, regional workshops on capacity-building and exchange of experiences on risk assessment risk management of LMOs. In addition, the COP-MOP decided to establish an
Ad Hoc Technical Expert Group on Risk Assessment was established to further consider the nature and scope of existing approaches to risk assessment, evaluate such approaches and identify any gaps, and identify capacity-building needs.
At its third meeting, COP-MOP further considered risk assessment and risk management on the basis of the report of the expert group, information received in interim national reports under the Protocol, and submissions and guidance materials that were compiled in advance of the second meeting of the COP-MOP. In
decision BS-III/11, COP-MOP examined further measures for enhancing capacity-building in risk assessment and risk management and outlined the process for collecting and sharing available information and guidance documents in order to facilitate the consideration, at the fourth meeting, of the need for further guidance on specific aspects of risk assessment and risk management.
