UNIDO Biosafety Manual

The UNIDO ‘South – South Biosafety Networking Programme’ entails several components, such as a distant-learning biosafety programme (e-Biosafety), which is a network that comprises universities from all over the world. As part of this programme, UNIDO also coordinating the preparation of a Biosafety Manual with practical guidance for the development of national biosafety regulations.

An important point of reference of this Manual is the Cartagena Protocol on Biosafety (CPB). Building on the recognition in the Preamble of the CPB that “modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health”, the overall objective of the CPB is: ” ... to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.”

In order to achieve its objective, the CPB has a number of important functions:
  1. It gives countries that do not yet have domestic biosafety regulations in place a legal basis and a methodology to make informed decisions on import of Living Modified Organisms (LMOs).
  2. It contributes to international harmonisation of national biosafety regulations by international agreement on some of the key elements of domestic biosafety regulations such as definitions, information requirements, principles and methodology on risk assessment, treatment of confidential information etc.
  3. It contains a crucially important mechanism for international information exchange on biosafety through its Biosafety Clearing House (BCH3).

In this context, this Manual provides practical guidance for national authorities that are in the process of developing national biosafety regulations:
  • Part I contains an overview of the broader international context relevant to biosafety.
  • Part II contains guidance on what is needed to establish adequate regulatory oversight capacities for the development and/or trade of LMOs.
  • Part III contains guidance on some practical aspects when applying the procedures of the CPB for the import of LMOs for intentional releases.

This version of the Manual, which is currently being used in UNIDO the distant learning biosafety programme, contains Part I and Part III. In the Autumn of 2010 Part II will be completed and be published on the UNIDO website together with updates of Part I and Part II.

Please click here to download a PDF file of the Manual