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This book is published on the responsibility of the Working Group on Harmonisation of Regulatory Oversight in Biotechnology, u;hich is a subsidiary group of the Chemicals Committee and Working Party on Chemicals, Pesticide and Biotechnology of the OECD.

© OECD 2006 No reproduction, copy, transmission or translation of this publication may be made without written permission.

The published Consensus Documents are also available individually from OECD's website ( at no cost. Clive James (2005), International Service for the Acquisition of Agri-biotech Applications ( 3 Copyfighled material Copyfighled material Table of Contents TABLE OF CONTENTS (Please note that this table of contents is only for Volume 1 of this publication. It could lead to countries recognising or even accepting information from one anothers' assessments. It increases mutual understanding among member countries, which avoids duplication, saves on scarce resources and increases the efficiency of the risk/safety assessment process.

A second volume is also available) FORRWOR n ^ TNTROn TTCTTON TO THF. This in turn improves safety, while reducing unnecessary barriers to trade (OECD 2000).

To date, 25 Biosafety Consensus Documents have been published.

They include documents which address the biology of crops, trees and micro- organisms as well as those which address specific traits which are used in transgenic crops. Q Section 1 Points to Consider for Consensus Documents on the Biology of Cultivated Plants 30 Section 2 Soybean (Glycine max (L.) Marr.) 40 Section 3 Maize (Zea mays subsp.

Safety Assessment of Transgenic Organisms OECD CONSENSUS DOCUMENTS Volume 1 and 2 Safety Assessment of Transgenic Organisms OECD CONSENSUS DOCUMENTS Volume 1 OECD ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT The OECD is a unique forum where the governments of 30 democracies work together to address the economic, social and environmental challenges of globalisation.

The OECD is also at the forefront of efforts to understand and to help governments respond to new developments and concerns, such as corporate governance, the information economy and the challenges of an ageing population.

As such, it should be of value to applicants for commercial uses of transgenic crops, regulators in national authorities as well as the wider scientific community. They include: Argentina; Russia; Slovenia; the United Nations Environment Programme (UNEP); the Secretariat of the Convention on Biological Diversity (SCBD); the United Nations Industrial Development Organisation (UNIDO); and the Business and Industry Advisory Committee to OECD (BIAC). Regulatory Harmonisation The Working Group was established in 1995^ at a time when the first commercial transgenic crops were being considered for regulatory approval in a number of OECD Member countries.

(A summary of this extensive body of work is found in Annex I.) 4.

Key Background Concepts and Principles The Ad Hoc Group took into account (amongst other things) previous work on risk analysis that is summarised in Safety Considerations for Biotechnology: Scale-up of Crop Plants (OECD 1993a). Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY.

It also describes the process by which the documents are drafted using a "lead country" approach. 351 Section 3 The Genes and Their Enzymes that Confer Tolerance to Phosphinothricin Herbicide 360 Section 4 Herbicide Biochemistry, Herbicide Metabolism and the Residues in (Phosphinothricin) - Tolerant Transgenic Plants 370 5 Copyrighled malerial Table of Contents Tables Table 1.1 Consumption of maize per capita by country 48 Table 1.2 Classification of the genus Zea within the tribe Maydeae of the Western Hemisphere, and the genus Tripsacum 51 Table 1.3 Sexually obtained interspecific and intergeneric crosses with B. Environmental parameters for fruiting of oyster mushroom 284 Table 1.78 Estimated chromosome size of Pleurotus spp 285 Table 1.29 Classification of Capsicum annuum 294 Table 1.30 The species of Capsicum and their known or apparently natural distributions. Table 1.31 296 Morphological characters that generally differentiate the domesticated species of Capsicum 297 Table 1.32 Crossability of Capsicum annuum with other Capsicum in the three complexes of domesticated species 303 Table 2.1 Reported Viral Synergisms 340 6 Table of Contents Figures Figure 1 .

The second text is a Points to Consider for Consensus Documents on the Biology of Cultivated Plants. Napus 84 Table 1.4 Species belonging to the genus Oryza 95 Table 1.5 Comparison of main characters of domesticated cultivars of O. glaberrima 98 Table 1.6 Outcrossing rates estimated in wild and cultivated rice species by different methods 104 Table 1.7 Taxonomic position of S. 1 Maize production worldwide 48 Figure 1 .2 Evolutionary pathway of the two cultivated species of rice 96 Figure 1.3 Rice RFLP linkage map constrructed with 1,383 DNA markers 100 Figure 1.4 An overview of the diploid einkorn lineage 146 Figure 1 .5 Macroscopic feature of P. ostreatus 279 Figure 1.7 Life cycle of the Pleurotus ostreatus 283 Figure 2.1 Glyphosate Structure 352 Figure 2.2 L-isomer of phosphinothricin (left) compared to glutamate (right) 362 Figure 2.3 Metabolism of Glufosinate-Ammonium in Non-Transgenic and in Transgenic, Tolerant Crop Plants (Corn, Oilseed rape, Tomato, Soybean, Sugar beet) 373 7 Copyfighled material INTRODUCTION TO THE BIOSAFETY CONSENSUS DOCUMENTS 9 Copyfighled material Introduction to Biosafety Consensus Documents 1.

This is a structured checklist of "points to consider" for authors when drafting or for those evaluating a consensus document. About OECD's Working Group OECD's Working Group comprises delegates from the 30 Member countries of OECD and the European Commission.



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