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Safety Assessment of Transgenic Organisms, Volume 3

OECD Consensus Documents

image of Safety Assessment of Transgenic Organisms, Volume 3

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).

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Points to consider for consensus documents on the biology of cultivated plants

Most environmental risk/safety assessments of transformed (genetically modified or engineered) plants are based upon a broad body of knowledge and experience with the untransformed species based on familiarity with the crop plant. The intent of the biology consensus documents is to describe portions of this body of knowledge directly relevant to risk/safety assessment in a format readily accessible to regulators. The document is not an environmental risk/safety assessment of the species. Rather, the consensus document provides an overview of pertinent biological information on the untransformed species to help define the baseline and scope (the comparator against which transformed organisms will be compared), in the risk/safety assessment of the transformed organism. Consensus documents are not detailed crop handbooks or manuals of agricultural or silvicultural practice or economic botany, but rather focus on the biological information and data that may be clearly relevant to the assessment of newly transformed plants.

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