The module is broken up into 4 sections; Firstly a brief discussion of the techniques used in modern biotechnology; This will be followed by a detailed description of how to set the context and scope of a risk assessment; a description of the concept of a case-by-case assessment; and finally how to conduct the risk assessment.

Risk assessment is a process intended to calculate or estimate the risk to a given target organism, system, or (sub)population, including the identification of uncertainties, following exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system (WHO, 2004).

The risk assessment process involves a critical review of available data for the purpose of identifying and possibly quantifying the risks resulting from, for example, natural events (flooding, extreme weather events, etc.), technology, agricultural practices, processes, products, agents (chemical, biological, radiological, etc.) and any activity that may pose threats to ecosystems, animals and/or people.

The objective of a risk assessment under the Cartagena Protocol “is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health” (Annex III).

The results of risk assessments of living modified organisms (LMOs) are typically used by decision-makers to make informed decisions regarding the approval, with or without conditions (e.g. requirements for risk management and monitoring strategies) or prohibition of a certain use of the LMO.

This module provides an introduction to risk assessment and considerations that may assist risk assessors in conducting risk assessments of LMOs that are consistent with Article 15 and Annex III of the Protocol.