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  • 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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    The OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology (the Working Group) comprises delegates from the 33 member countries of OECD and the European Commission. Typically, delegates are from those government ministries and agencies, which have responsibility for the environmental risk/safety assessment of products of modern biotechnology. The Working Group also includes a number of observer delegations and invited experts who participate in its work, such as Argentina; the Russian Federation; the United Nations Environment Programme (UNEP) and; the Secretariat of the Convention on Biological Diversity (SCBD); the Food and Agriculture Organization of the United Nations (FAO), the United Nations Industrial Development Organisation (UNIDO); and the Business and Industry Advisory Committee to the OECD (BIAC). In recent years, with the increasing use of biotech products in many regions of the world together with the development of activities relating to tropical and subtropical species, there has been increased participation of non-member economies including Brazil, Cameroon, China, Estonia, India, the Philippines and South Africa.

  • 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.