Under the Cartagena Protocol on Biosafety - Where is the Roadmap for Risk Assessment Taking Us?

The paper summarizes the history of the development of the guidance on risk assessment, including the roadmap under the Cartagena Protocol on Biosafety since 2008 until now. The aim and the contents of the roadmap for risk assessment of living modified organisms (LMOs) are described, in particular the five steps in the risk assessment process. After several rounds of discussions at the expert and political level, the guidance including the roadmap is currently revised taking into account the results of an in-depth practical testing process by the Parties, Non-Parties, and relevant organizations.

Risk assessment of conventional crop plants in analogy to transgenic plants.

The risk assessment of genetically-modified plants pursuant to Annex II B of EU Directive 94/15/EC assumes that it is possible to infer the environmental impacts of a crop plant from its characteristics, so most of Annex II should also be applicable to conventional plants. To test this, we surveyed reports on the ecological impacts of the cultivation of non-transgenic crop plants with novel or improved traits and, in three cases, investigated whether Annex II B would have been adequate to indicate the effects. Such an assessment appears to be feasible only if the time frame on which it is based is short, so that long-term effects cannot be assessed.

The impact of the OECD on the development of national/international risk/safety assessment frameworks.

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.

Co-existence of agricultural production systems.

Strategies and best practices for the co-existence of GM and non-GM crops need to be developed and implemented with the participation of farmers and other stakeholders. According to the principle of 'subsidiarity', decisions should be made by the lowest authority possible. When applying this concept to the case of GM crops, the affected society should determine their use and management in a regional decision-making process.

Suggestions for the assessment of the allergenic potential of genetically modified organisms.

The prevalence of allergic diseases has been increasing continuously and, accordingly, there is a great desire to evaluate the allergenic potential of components in our daily environment (e.g., food).