Considerable public debate has emerged over the perceived benefits and risks of genetically modified organisms (GMOs), which in many countries is leading to increased government regulation of R&D and trade in GMOs. Under terms of the Convention on Biological Diversity, negotiations began in 1995 to develop a protocol on biosafety. In January 2000, over 130 governments reached agreement on the legally binding Protocol, which will regulate the safe transfer, handling, and use of GMOs. The ultimate goal of the agreement is to ensure an adequate level of protection against potential adverse effects on the conservation and sustainable use of biological diversity. Biosafety is achieved by assessing and managing environmental and health risks of new technologies, evaluating the potential ecological and health consequences, and weighing these against potential benefits. During the past decade, national biosafety systems have gained importance as mechanisms for ensuring the safe use of biotechnology products without imposing unacceptable risk to human health or the environment, or unintended constraints to technology transfer. This country report presents an analysis of the development and present status of the biosafety system in Argentina and its impact on the commercialization of genetically modified organisms. The specific objectives of the report are:1. to assess the efficacy of biosafety policies and procedures associated with the introduction of biotechnology development in Argentina;2. to develop recommendations for enhancing the operation of Argentina's biosafety system and minimizing potential constraints to technology transfer;3. to identify areas where ISNAR and other international providers can provide further assistance.The study focused on the human and organizational aspects of the Argentine biosafety system. Major points of interest were (1) the organization, membership, and operations of the government agencies involved in regulating GMOs; (2) the nature and availability of information on biosafety procedures and requirements; (3) the path of regulatory review and approval leading to commercial release; and (4) the personal experiences of applicants and reviewers in dealing with the biosafety system. Findings and recommendations in the report may serve as the basis for discussions to strengthen and adapt the biosafety system to the changing context for biotechnology products in Argentina. They may also serve to advance efforts in the areas of public acceptance, technology transfer and regulatory harmonization.