From their first commercialisation in the mid-1990s, genetically engineered crops (also known as “transgenic” or “genetically modified” plants) have been approved for commercial release in an increasing number of countries, for planting or for entering in the composition of foods and feeds, or use in industrial processing. Up to now, the large majority of these agricultural productions remain for soybean, maize, cotton and rapeseed (canola), as outlined in The Bioeconomy to 2030: Designing a Policy Agenda (OECD, 2009). Despite some differences in total estimates, all analyses and statistics concur in underlining the general increasing trend in volumes produced and traded, number of countries involved and growth potential. For instance, James reports in the Global Status of Commercialized Biotech/GM Crops: 2014, ISAAA Brief No. 49 that the surface area of transgenic crops worldwide constantly increased over the 19-year-period from 1996 to 2014, to reach 181.5 million hectares grown in 28 countries. To date, genetically engineered varieties of over 25 different plant species (including crops, flowers and trees) have received regulatory approval in OECD and non-OECD countries from all regions of the world. Such approvals for release in the environment usually follow a science-based risk/safety assessment before being granted.

This document constitutes the fifth volume of the OECD Series on Harmonisation of Regulatory Oversight in Biotechnology, which relates to the environmental risk/safety assessment of transgenic organisms, also called “biosafety”. It is a compendium collating in a single volume the individual “consensus documents” published by the Working Group on the Harmonisation of Regulatory Oversight in Biotechnology. The four previous volumes of the series covered the documents issued during the 1996- 2010 period. This volume contains the consensus documents issued in 2011 and 2012, while Volume 6 will collate those published in 2013, 2014 and 2015.

The OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology (the “Working Group”) comprises delegates from the 34 member countries of the OECD and the European Commission. Typically, delegates are from those government ministries and agencies which have responsibility for the environmental risk/safety assessment of products of modern biotechnology. The Working Group also includes a number of observer delegations and invited experts who participate in its work, such as Argentina, the Russian Federation, the United Nations Environment Programme (UNEP), the Secretariat of the Convention on Biological Diversity (SCBD), the Food and Agriculture Organization of the United Nations (FAO), the United Nations Industrial Development Organisation (UNIDO) and the Business and Industry Advisory Committee to the OECD (BIAC).