This publication results from the common effort of the participants of the OECD Working Party on the Harmonisation of Regulatory Oversight in Biotechnology (WP-HROB), concluding a long-standing project achieved in 2023. It contains the OECD Consensus Document on Environmental Considerations for Risk/safety Assessment for the Release of Transgenic Plants, a document of major importance dealing with the ‘core’ of the biosafety work, justifying its publication as a stand-alone Volume 10 of the series of compendium publications.
Canada served as the lead of the Steering Group that drove the development of this document, followed by the Bureau of the WP-HROB from 2020 onward. The various parts of the document were each drafted by a sub-group of relevant experts and authorities, under the leadership of Canada (main body); Australia (Annex A); Mexico and then the United States (Annex B); Belgium (Annex C); the Netherlands (Annex D); United States (Annex E); Canada (Annex F); and Finland (Annex G). The draft document also benefitted from successive inputs from other WP-HROB delegates and experts, whether from OECD member countries, non-member economies and observer organisations.
Philip Mcdonald (Canada) was instrumental in the original idea for this document and that it could be framed around a set of common ‘environmental considerations’. The contribution of the late Dr Alan Raybould (BIAC) regarding the use of the ‘problem formulation approach’ is also acknowledged.
This volume 10 was prepared by Akihiro Kagoshima under the supervision of Bertrand Dagallier, at the EHS Division of the OECD Environment Directorate. The OECD is grateful to the scientists, regulators and authorities who participated in the development of the body text and the seven Environmental Considerations, and wishes to thank each of them.