The Secretariat of the Convention on Biological Diversity (CBD) has released 'Guidance on Risk Assessment of Living Modified Organisms (LMOs) and Monitoring in the Context of Risk Assessment'.
This Guidance provides a voluntary, non-prescriptive reference for Parties to the Cartagena Protocol on Biosafey for conducting risk assessments in the context of transboundary movements of LMOs.
The Guidance contains: a general roadmap for risk assessment on all LMOs; specific guidance for LMO plants with stacked genes or traits, LMO plants with tolerance to abiotic stress, LMO trees, and LMO mosquitoes; and guidance on monitoring.
4 December 2016: The Secretariat of the Convention on Biological Diversity (CBD) has released ‘Guidance on Risk Assessment of Living Modified Organisms (LMOs) and Monitoring in the Context of Risk Assessment,’ for Parties to the Cartagena Protocol on Biosafety to the CBD.
The guidance supports the identification and evaluation of potential adverse effects of LMOs on the conservation and sustainable use of biodiversity, taking also into account risks to human health.
The Guidance document, published as No. 4 of the Biosafety Technical Series, contains three parts. A general roadmap for risk assessment of all LMOs introduces the basic concepts and steps of integrated risk assessment, including overarching issues in the risk assessment process, the planning phase of risk assessments and steps in conducting risk assessments. The second part provides guidance for specific types of LMOs and traits, including LMO plants with stacked genes or traits, LMO plants with tolerance to abiotic stress, LMO trees, and LMO mosquitoes species that act as vectors of human and animal diseases. The final part addresses monitoring LMOs released into the environment.
The Guidance on Risk Assessment was developed in response to Article 15 of the Biosafety Protocol, which requires Parties that import LMOs to ensure that risk assessments are carried out for decisions on transboundary movements of LMOs under the Protocol. Annex III to the Protocol lays out the general principles, methodology and points to consider for risk assessments under the Protocol, including the principle that risk assessment should be carried out in a scientifically sound and transparent manner.
The main objective of the guidance is to provide a voluntary, non-prescriptive reference for Parties for conducting risk assessments under the Protocol in line with Annex III. It can be used by any stakeholder involved in risk assessments, including assessors working for national competent authorities and assessors representing the applicant or developer of an LMO.
The document was developed through several rounds of expert group meetings, consideration by the Meeting of the Parties to the Protocol, as well as consultations and testing that stretched over a period of over ten years. The guidance is considered to be a living document that can be updated as mandated by the Conference of the Parties serving as the meeting of the Parties (COP-MOP) to the Protocol. Elements currently under discussion by COP-MOP 8 that may be added to the guidance include specific guidance on LMO fish and LMOs developed through synthetic biology. [Guidance on Risk Assessment of Living Modified Organisms (LMOs) and Monitoring in the Context of Risk Assessment] [Outline of Guidance on Risk Assessment of LMO Fish] [Outline of Guidance on Risk Assessment of LMOs Developed through Synthetic Biology] [IISD RS Coverage of UN Biodiversity Conference inclusive of COP-MOP 8]