Harmonisation of Regulatory Oversight in Biotechnology

English
ISSN: 
2311-4622 (online)
ISSN: 
2414-6854 (print)
http://dx.doi.org/10.1787/23114622
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This Series represents a compilation of the science-based consensus documents developed by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology since 1995. The consensus documents are prepared by authorities of OECD members and other economies associated with this work. They contain information for use during the regulatory assessment of organisms produced from modern biotechnology - transgenic crops, trees, animals and micro-organisms - intended for release in the environment for agriculture, animal farming, forestry or other purposes. Information relevant to environmental risk assessment (biosafety) includes biology, reproduction, genetics, ecology, and other elements. Knowledge of the traits introduced in the organisms, and their biotechnological developments, is also critical. These documents are of value to applicants for commercial uses of transgenic organisms, to regulators and risk assessors in charge of granting approvals to their environmental release, as well as to the wider scientific community.

 
Safety Assessment of Transgenic Organisms in the Environment, Volume 5

Safety Assessment of Transgenic Organisms in the Environment, Volume 5

OECD Consensus Documents You or your institution have access to this content

English
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Author(s):
OECD
05 Apr 2016
Pages:
296
ISBN:
9789264253018 (PDF) ;9789264250444(print)
http://dx.doi.org/10.1787/9789264253018-en

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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).

 

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  • Foreword and Acknowledgements

    From their first commercialisation in the mid-1990s, genetically engineered crops (also known as "transgenic" or "genetically modified" plants) have been approved for commercial release in an increasing number of countries, for planting or for entering in the composition of foods and feeds, or use in industrial processing. Up to now, the large majority of these agricultural productions remain for soybean, maize, cotton and rapeseed (canola), as outlined in The Bioeconomy to 2030: Designing a Policy Agenda (OECD, 2009). Despite some differences in total estimates, all analyses and statistics concur in underlining the general increasing trend in volumes produced and traded, number of countries involved and growth potential. For instance, James reports in the Global Status of Commercialized Biotech/GM Crops: 2014, ISAAA Brief No. 49 that the surface area of transgenic crops worldwide constantly increased over the 19-year-period from 1996 to 2014, to reach 181.5 million hectares grown in 28 countries. To date, genetically engineered varieties of over 25 different plant species (including crops, flowers and trees) have received regulatory approval in OECD and non-OECD countries from all regions of the world. Such approvals for release in the environment usually follow a science-based risk/safety assessment before being granted.

  • Executive summary

    This document constitutes the fifth volume of the OECD Series on Harmonisation of Regulatory Oversight in Biotechnology, which relates to the environmental risk/safety assessment of transgenic organisms, also called "biosafety". It is a compendium collating in a single volume the individual "consensus documents" published by the Working Group on the Harmonisation of Regulatory Oversight in Biotechnology. The four previous volumes of the series covered the documents issued during the 1996- 2010 period. This volume contains the consensus documents issued in 2011 and 2012, while Volume 6 will collate those published in 2013, 2014 and 2015.

  • Introduction to the biosafety consensus documents

    The OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology (the "Working Group") comprises delegates from the 34 member countries of the 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), 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).

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  • Expand / Collapse Hide / Show all Abstracts Micro-organisms

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    • Bacteria

      This chapter provides guidance on topics and issues relevant to the risk/safety assessment of commercial environmental applications involving genetically engineered micro-organisms, especially bacteria. It explores the important aspects in bacteria for causing adverse human health effects, and how this knowledge can be used in biosafety regulatory assessment. It contains information on bacterial pathogenicity (general considerations, factors and determinants, genetics and molecular biology), and also elements on assessing potential for bacteria-mediated adverse human health effects.

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  • Expand / Collapse Hide / Show all Abstracts Biology of crops

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    • Squashes, pumkins, zucchinis and gourds (Cucurbita species)

      This chapter deals with the biology of squashes, pumkins, zucchinis and gourds (Cucurbita species). It contains information for use during the risk/safety regulatory assessment of genetically engineered varieties intended to be grown in the environment (biosafety). It includes elements of taxonomy, centres of origin and distribution, morphological characters, reproductive biology, genetics, hybridisation and introgression, crop production and cultivation practices, interactions with other organisms, pests and pathogens, and biotechnological developments.

    • Brassica crops (Brassica species)

      This chapter deals with the biology of Brassica species which comprise oilseed rape, turnip rape, mustards, cabbages and other oilseed crops. The chapter contains information for use during the risk/safety regulatory assessment of genetically engineered varieties intended to be grown in the environment (biosafety). It includes elements of taxonomy for a range of Brassica species, their centres of origin and distribution, reproductive biology, genetics, hybridisation and introgression, crop production, interactions with other organisms, pests and pathogens, breeding methods and biotechnological developments, and an annex on common pathogens and pests.

    • List of OECD consensus documents on environmental safety assessment, 1996-2015
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