Safety Assessment of Transgenic Organisms in the Environment, Volume 5
OECD Consensus Documents
This series represents a compilation of the biosafety consensus documents developed by the OECD Working Group on Harmonisation of Regulatory Oversight in Biotechnology over the periods 2011-12 (Volume 5) and 2013-15 (Volume 6). Volumes 5 and 6 describe the biology, centres of origin, genetics, hybridisation, production and use, and ecology elements of several crops (sugarcane, cassava, sorghum, common bean, cucurbits) and trees (eucalyptus species). They also provide considerations on pathogenicity factors in assessing the potential adverse health effects of bacteria, and the low level presence of transgenic plants in seed and grain commodities.
The consensus documents contain information for use during the regulatory assessment of products of modern biotechnology, i.e. transgenic organisms (plants, animals, micro-organisms), when intended for release in the environment. As such, it should be of value to applicants for use of genetically-engineered organisms in agriculture mainly, to regulators and risk assessors in national authorities for their biosafety assessments, as well as the wider scientific community. More information on this OECD programme is found at BioTrack online (www.oecd.org/biotrack).
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Foreword and Acknowledgements
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.
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