Abstract:

During the period 2002-10, FAO undertook an intense activity of biosafety capacity development, largely centred on enhancing the capacities of regulators and other technical staff involved in the implementation of biosafety frameworks, along with other components. The training programme was tailored to meet the needs of a very specific audience: biosafety regulators, policy-makers and members of national biosafety committees, with diverse educational backgrounds, not necessarily well versed in all the biosafety-related fields. The training courses therefore aimed to: i) offer background knowledge critical in the process of reviewing biosafety dossiers and biosafety-related decision-making; ii) provide acquaintance with concepts and methodologies relevant to risk analysis of genetically modified organism (GMO) release and biosafety management.

The training programme consisted of the following modules:

Module A: Introduction to molecular biology and genetic engineering. This reviews the very basic scientific concepts and principles employed in producing GMOs, and provides a brief description of current and emerging uses of biotechnology in crops, livestock and fisheries.

Module B: Ecological aspects. This provides the necessary background information on ecology and evolution needed to analyse and understand the consequences of introducing GMOs into the environment.

Module C: Risk analysis. This provides basic information on biological risks, concepts, principles, and methodologies of risk assessment, risk management and risk communication. It focuses on crop biotechnology and environmental risk assessment of GM crops since these are of immediate interest to most countries.

Module D: Test and post-release monitoring of GMOs. This addresses the use and monitoring of GMOs under containment, confinement and limited field trials, as well as the monitoring of commercially released GMOs. It also covers surveillance and emergency planning.

Module E: Legal aspects. This provides an overview of the existing legal tools and frameworks on biotechnology and biosafety, and offers a thorough description of the international instruments that regulate biosafety and their interactions.

This Biosafety Resource Book stems from experience gained in biosafety capacity development projects and is based on the materials developed by the lecturers who have taught in the FAO training courses organized to date. It has been prepared in response to an expressed need, with the purpose of being used as a training tool in future activities. It also aims at providing biosafety regulators, policy-makers and members of national biosafety committees with reference materials that can be readily consulted beyond the training events, when the need arises. Special attention has been paid to avoid technical jargon and to keep the modules scientifically accurate as well as accessible to non-specialists.