Transgenic plants and safety regulation

Summary

Harmonisation of regulatory oversight of transgenic plants does not mean that all regulatory agencies must have identical legislation, information requirements, assessment processes and resulting decisions. Rather, it means that they seek to build consensus on the science that they use to assess the safety of the release of transgenic plants. Even though there may be differences in the outcomes of biosafety assessments because of the different environments into which transgenic plants may be released, there is recognition that much information (data) already available are relevant to transgenic plant biosafety assessment. The Organisation of Economic Cooperation Member countries, through the development of Consensus Documents, present this knowledge in a format that can expedite the safety assessment of transgenic plants. These documents can be considered as “mutual recognition of data,” and are a means of moving towards harmonised regulatory decision making. To date the OECD Member countries are working on three types of Consensus Document: plant species biologies which focus specifically on centres of origin and diversity, and on related plant species with which that species can hybridise; general trait documents which focus on scientific issues arising from the development of such general traits as coat protein mediated virus resistance; and, specific trait documents which focus on the characteristics of specific genes and the resulting gene products that confer the novel trait to the transgenic plant.