Guidance on risk assessment of living modified organisms and monitoring in the context of risk assessment

This document was developed by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, with input from the Open-ended Online Expert Forum, in accordance with terms of reference set out by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) in its decisions BS-IV/11 and BSV/12 in response to an identified need for further guidance on risk assessment of LMOs. 4 It is intended to be a “living document” that may be updated and improved as appropriate and when mandated by the Parties to the Cartagena Protocol on Biosafety. The objective of this Guidance is “to provide a reference that may assist Parties and other Governments in implementing the provisions of the Protocol with regards to risk assessment, in particular its Annex III and, as such, this Guidance is not prescriptive and does not impose any obligations upon the Parties”.5 It may be used by any stakeholder involved in the risk assessment process, including risk assessors who work at or advise national competent authorities and risk assessors representing the applicant or developer of the LMO. This Guidance focuses on LMOs that result from the application of modern biotechnology as per definition in Article 3(i)(a) of the Protocol. It consists of three parts: Part I containing a Roadmap for Risk Assessment of LMOs, Part II containing guidance for the risk assessment of specific types of LMOs or traits, and Part III containing guidance for monitoring of LMOs released into the environment. The topics contained in Parts II and III were identified and prioritized by the Open-ended Online Expert Forum and the AHTEG in accordance with the terms of reference in decisions BS-IV/11 and BS-V/12, taking into account the need of Parties for additional guidance.

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