Harmonisation of Regulatory Oversight in Biotechnology

This Series represents a compilation of the science-based consensus documents developed by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology since 1995. The consensus documents are prepared by authorities of OECD members and other economies associated with this work. They contain information for use during the regulatory assessment of organisms produced from modern biotechnology - transgenic crops, trees, animals and micro-organisms - intended for release in the environment for agriculture, animal farming, forestry or other purposes. Information relevant to environmental risk assessment (biosafety) includes biology, reproduction, genetics, ecology, and other elements. Knowledge of the traits introduced in the organisms, and their biotechnological developments, is also critical. These documents are of value to applicants for commercial uses of transgenic organisms, to regulators and risk assessors in charge of granting approvals to their environmental release, as well as to the wider scientific community.