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Volume 7 of the Series compiles the OECD consensus documents for use in environmental risk assessment of transgenic organisms (biosafety) issued in 2016 and 2017.
The first two chapters cover the biology of plant species (sorghum and tomato) and include elements of taxonomy, centres of origin, reproductive biology, genetics, outcrossing, crop production and cultivation practices, interactions with other organisms, main pests and pathogens, and biotechnological developments.
The third chapter relates to Atlantic salmon, the first OECD biosafety publication to address an animal species. It describes the biology and ecology of wild salmon (including classification, life stages, reproduction, centres of origin, geographical distribution, population dynamics, interaction with other organisms) and of the farmed form (domestication, aquaculture rearing practices, biocontainment, interactions with the external environment). It also provides elements of genetics, research on genetically engineered salmon and resources for its risk assessment.
This OECD database allows regulatory officials and stakeholders to share information on products derived from the use of modern biotechnology, as well as some products with novel traits acquired by the use of conventional breeding or mutagenesis, that have been approved for commercial application in at least one country, in terms of food, feed or environmental safety.
Most OECD countries and many non-members have a system of regulatory oversight for products of modern biotechnology (genetically-engineered /transgenic organisms) which are intended for release to the environment. The OECD biosafety work programme aims to consider all types of organisms (plants, trees, animals, micro-organisms) and to promote international harmonisation.
The OECD developed the BioTrack Product Database which accommodates Unique Identifiers to each transgenic (or genetically engineered) plant that is approved for commercial use, including planting and food/feed use. These Unique Identifiers are intended to be used as "keys" to access information of each transgenic product in this database and to ensure the safety of modern biotechnology products
These documents focus on the biology of organisms (such as plants, trees or micro-organisms) or introduced novel traits.
These documents contain elements for use during the regulatory assessment of a particular food/feed product such as those derived from transgenic organisms.
This work aims to assist countries evaluating the potential risks of transgenic products, ensure high safety standards, and foster mutual understanding of relevant regulations.
The document addresses compositional considerations for new varieties of rice by identifying the key food and feed nutrients, anti-nutrients, and other constituents. A general description of these components is provided including background material on the cultivated rice species, production, consumption, processing and uses of rice, and considerations to be taken into account when assessing new varieties of this crop.
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).