Safety Assessment of Transgenic Organisms, Volume 4

OECD Consensus Documents

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The books on “Safety Assessment of Transgenic Organisms” constitute a compilation of the OECD Biosafety Consensus Documents. When published, Volume 1 and 2 contained the documents issued before 2006; Volume 3 and 4 are a continuation of the compilation up to 2010.

The OECD Biosafety Consensus Documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries and some non members associated with the work. This is intended to encourage information sharing, promote harmonised practices, and prevent duplication of effort among countries.

These books offer ready access to those consensus documents which have been issued on the website thus far. As such, it should be of value to applicants for commercial uses of transgenic organisms (crops, trees, microorganisms), to regulators and risk assessors in national authorities, as well as the wider scientific community.

More information on the OECD's work related to the biosafety of transgenic organisms is found at BioTrack Online (http://www.oecd.org/biotrack).



Genetically engineered crops (also known as transgenic crops) have been approved for commercial release in an increasing number of countries, for planting or for use as commodities. Genetically engineered varieties of over a dozen different plant species have received regulatory approval in several OECD and non-OECD countries from all regions of the world, the large majority of plantings being for soybean, maize, cotton and rapeseed (canola), as outlined in The Bioeconomy to 2030: Designing a Policy Agenda (OECD, 2009). During the period from 1996 to 2009, for example, there was an almost eighty-fold increase in the area grown with transgenic crops worldwide, reaching 134 million hectares in 2009, as mentioned in Global Status of Commercialized Biotech/GM Crops (James, 2009). Such approvals usually follow a science-based risk/safety assessment.


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