The scientific organizers of the symposium put much emphasis on the identification and definition of hazard and the potential consequences thereof and three full sessions with a total of 13 presentations encompassing a wide range of related themes were planned for this topic. Unfortunately, one talk had to be cancelled because of illness of the speaker (BM Khadi, India). Some presentations covered conceptual approaches for environmental risk assessment (ERA) of GM plants (problem formulation in the risk assessment framework, familiarity approach, tiered and methodological frameworks, non-target risk assessment) and the use of models in assessing invasiveness and weediness of GM plants. Other presentations highlighted the lessons learned for future ERA from case studies and commercialized GM crops, and from monitoring of unintended releases to the environment. When the moderators of the three sessions came together after the presentations to align their summaries, there was an obvious need to restructure the 12 presentations in a way that allowed for a consistent summarizing discussion. The following new organization of the 12 talks was chosen: (1) Concepts for problem formulation and non-target risk assessment (2) Modeling as a tool for predicting invasiveness of GM plants (3) Case-studies of ERA of large-scale release (4) Lessons learned for ERA from a commercialized GM plant (5) Monitoring of unintended release of Bt maize in Mexico. The new thematic structure facilitates a more in-depth discussion of the presentations related to a specific topic, and the conclusions to be drawn are thus more consistent. Each moderator agreed to take responsibility for summarizing one or more themes and to prepare the respective report.

Biosafety regulatory frameworks are intended to serve 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. In several regulatory systems GMO risk assessment has been separated from GMO risk management. As a consequence, risk assessment can be performed on a purely scientific basis, whereas risk management can take additional aspects (e.g. socio-economic or ethical) into consideration. For instance, the European Food Safety Authority (EFSA), the keystone of European Union risk assessment regarding food and feed safety, provides independent scientific advice and clear communication on existing and emerging risks in close collaboration with national authorities and in open consultation with its stakeholders. Risk management measures are not within the remit of EFSA, and remain the responsibility of the European Commission and Member States.

The role of OECD in the development of national and international risk/safety assessment frameworks is presented and discussed. The most relevant OECD bodies in this context have contributed a lot to the development of international biosafety frameworks, inter alia by organizing international conferences in the areas of food/feed and environmental safety of GMOs, focusing on practical and current scientific issues. The OECD Consensus Documents as well as the OECD Product Database have provided a good basis for risk/safety assessment frameworks and their implementation. The relevance for the OECD work in the international area is discussed, in particular, with respect to the work undertaken under the Cartagena Protocol on Biosafety, the Codex Alimentarius Commission and its work in biotechnology, as well as under the International Plant Protection Convention. An outlook and suggestions for future directions of OECD work in this area are presented.

The OECD Blue Book, "Recombinant DNA: Safety Considerations" was published in 1986. The developed principles and concepts on the stepwise and case-by-case approach for risk assessment in the Blue Book have been used as a foundation for building national biosafety frameworks and international instruments for the regulation of the products of modern biotechnology. Twenty years after the Blue Book was published, OECD continues its activities on unique identifier systems, information-sharing, consensus documents for the biology of crops, trees and microorganisms with respect to harmonization of regulatory oversight and those of novel food and feed safety. These activities benefit, without any doubt, the international community at large, including OECD non-member countries. In order to strengthen its position in the international arena and to better respond to the needs of the changing world, OECD would be encouraged to participate in a more active manner in the technology transfer process and co-existence debate, together with continuing the organization's efforts on information-sharing and harmonization in the field of biotechnology and biosafety.

Biosafety regulatory frameworks are intended to serve 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. The OECD Blue Book on "Recombinant DNA Safety Considerations", setting out principles and concepts for handling genetically modified organisms safely outside of contained laboratory conditions, was a milestone in the history of biotechnology. The "Recombinant DNA Safety Considerations" definitively became the major resource for the formulation of national regulatory frameworks and international regulations, including the Cartagena Protocol. 


The Blue Book made a big contribution to the development of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) guidelines established in 1991 for almost all of the basic issues. However, the MAFF guidelines could not sufficiently cover some important areas that the Blue Book addressed well, such as potential consequences. This gap has been recovered substantially by a new law established in 2003. Japan still faces several important issues, including assessment of stacked products, potential consequences, comparative assessment, assessment of imported GM commodities and movement of concerned groups.


The Organization for Economic Cooperation and Development's (OECD) Working Group for the Harmonization of Regulatory Oversight (Working Group) has taken the opportunity over the last several years to identify the challenges to environmental risk assessment of transgenic organisms, particularly plants. These initiatives have included most importantly, a report to the G8, the Rapporteur's Report from the OECD international symposium on LMOs and the Environment; and an internal workshop on Review of Consensus Documents and Future Work in Harmonization that emphasized priority setting. The outcome of these endeavors has informed the development of subsequent programs of work adopted by the Working Group. This paper identifies points raised at these conferences and meetings that relate to the science underpinning risk/safety assessment. Many of the points are similar over the timeframe of these endeavors and are still of current importance. The discussions at the OECD workshop on risk assessment held in Korea during the 9th International Symposium on the Biosafety of Genetically Modified Organisms will also influence the subsequent projects and priorities of the Working Group.