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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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Section 1 - Safety information on transgenic plants expressing Bacillus thuringiensis - Derived insect control protein

This section summarises the information available on the source of Bacillus thuringiensis ..-endotoxin genes, the structure and properties of the toxins they encode, unique mechanisms of action, use in plants, toxicity and exposure data, and assessment methods. Some information on Bacillus thuringiensis, the bacterial source of these traits, is included as background and where relevant to the risk assessment of the ..-endotoxins in plants, however this section does not attempt to address the vast amount of information available on the micro-organism. In addition to the scientific literature, which grew substantially over the last few years, this section also contains data submitted by registration applicants for the US-registered plant pesticide products (called plant-incorporated protectants in US pesticide regulations). These studies are required to be performed according to good laboratory practices regulations (US Code of Federal Regulations 40 CFR 160) and have been peer reviewed by USEPA scientists for acceptability for use in an environmental assessment. In the US, data from these studies may be released to the public and are available from the companies on request by other regulatory bodies. Some of these data were submitted for products that are no longer registered; however, the data are still valid to illustrate ..-endotoxin properties. Where it is necessary to illustrate assessments unique to these toxin genes, plant expression data are discussed. However, the intent of this section is not to address gene transfer or other issues unique to specific plants that have been transformed to express these toxins. Such information is outside the scope of this section. It is intended that this section should be used in conjunction with specific plant species biology consensus documents when a biosafety assessment is made of plants with Bacillus thuringiensis ..-endotoxin-mediated insect protection. It was also agreed that this section would not address the issue of insect resistance management, designed to prevent or delay the onset of resistance to specific ..-endotoxins in insects exposed to these transgenic crops.

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