Safety assessment of transgenic organisms : OECD consensus documents.

448 Pages·2006·2.889 MB·English

by  OECD

Safety Assessment of Transgenic Organisms
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Safety Assessment
The goal of the OECD Biosafety Consensus Documents is to identify elements of scientific
information used in the environmental safety and risk assessment of transgenic organisms which
are common to OECD member countries. This is intended to encourage information sharing and of Transgenic
prevent duplication of effort among countries.
This book offers ready access to those consensus documents which have been published Organisms
thus far. 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.
OECD CONSENSUS DOCUMENTS
More information on the OECD’s work related to the biosafety of transgenic organisms is found
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at BioTrack Online (www.oecd.org/biotrack).
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The full text of this book is available on line via these links: A
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http://www.sourceoecd.org/scienceIT/9264022589 S
http://www.sourceoecd.org/agriculture/9264022589 E
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http://www.sourceoecd.org/environment/9264022589
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Those with access to all OECD books on line should use this link: E
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http://www.sourceoecd.org/9264022589
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Safety Assessment
of Transgenic Organisms
OECD CONSENSUS DOCUMENTS
Volume 2
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. The Organisation provides a setting where governments can compare policy
experiences, seek answers to common problems, identify good practice and work to co-ordinate
domestic and international policies.
The OECD member countries are: Australia, Austria, Belgium, Canada, the Czech Republic,
Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Korea,
Luxembourg, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal, the Slovak Republic,
Spain, Sweden, Switzerland, Turkey, the United Kingdom and the United States. The Commission of
the European Communities takes part in the work of the OECD.
OECD Publishing disseminates widely the results of the Organisation’s statistics gathering and
research on economic, social and environmental issues, as well as the conventions, guidelines and
standards agreed by its members.
This book is published on the responsibility of the Working Group on Harmonisation of
Regulatory Oversight in Biotechnology, which 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. Applications should be sent to
OECD Publishing: [email protected] or by fax [phone]. Permission to photocopy a portion of this work should be addressed to the Centre
français d'exploitation du droit de copie, 20, rue des Grands-Augustins, 75006 Paris, France ([email protected]).
Foreword
FOREWORD
Genetically engineered crops (also known as transgenic crops) such as maize, soybean, rapeseed and
cotton have been approved for commercial use in an increasing number of countries. During the period
from 1996 to 2005, for example, there was more than fifty-fold increase in the area grown with transgenic
crops worldwide, reaching 90 million hectares in 20051. Such approvals usually follows a science-based
risk/ safety assessment.
The environmental safety/ risks of a transgenic organism have been assessed based on the information
on the characteristics of the host organism, the introduced traits, the environment into which the organism
is introduced, the interaction between these, and the intended application. The OECD’s Working Group on
Harmonisation of Regulatory Oversight in Biotechnology decided at its first session, in June 1995, to focus
its work on identifying parts of this information, which could be commonly used in countries for
environmental safety/ risk assessment to encourage information sharing and prevent duplication of effort
among countries. Biosafety Consensus Documents are one of the major outputs of its work.
Biosafety Consensus Documents are intended to be a “snapshot” of current information on a specific
host organism or trait, for use during regulatory assessments. They are not intended to be a comprehensive
source of information on everything that is known about a specific host or trait; but they do address the key
or core set of issues that member countries believe are relevant to risk/ safety assessment. This information
is said to be mutually acceptable among member countries. 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.
This book is a compilation of those Biosafety Consensus Documents published before February 2006.
It also includes two recently published texts: the first, entitled An Introduction to the Biosafety Consensus
Document of OECD’s Working Group for Harmonisation in Biotechnology, explains the purpose of the
consensus documents and how they are relevant to risk/ safety assessment. It also describes the process by
which the documents are drafted using a “lead country” approach. The second text is a Points to Consider
for Consensus Documents on the Biology of Cultivated Plants. This is a structured checklist of “points to
consider” for authors when drafting or for those evaluating a consensus document. Amongst other things,
this text describes how each point is relevant to risk/ safety assessment.
This book offers ready access to those consensus documents which have been published thus far. 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. As each of the documents may be updated in the
future as new knowledge becomes available, users of this book are encouraged to provide any information
or opinions regarding the contents of this book or indeed, OECD’s other harmonisation activities. If
needed, a short pre-addressed questionnaire is attached at the end of this book that can be used to provide
such comments.
The published Consensus Documents are also available individually from OECD’s website
(http://www.oecd.org/biotrack) at no cost.

1. Clive James (2005), International Service for the Acquisition of Agri-biotech Applications
(http://www.isaaa.org/)
3

Table of Contents
TABLE OF CONTENTS
CONSENSUS DOCUMENTS ON THE BIOLOGY OF TREES................................................9
Section 1 Eastern White Pine (Pinus strobus L.).....................................................................10
Section 2 European White Birch (Betula pendula Roth).........................................................45
Section 3 Norway Spruce (Picea abies (L.) Karst)..................................................................75
Section 4 Poplar (Populus L.)................................................................................................100
Section 5 Sitka Spruce (Picea Sitchensis (Bong.) Carr.).......................................................136
Section 6 Stone Fruits (Prunus spp.)......................................................................................175
Section 7 White Spruce (Picea glauca (Moench) Voss)........................................................204
CONSENSUS DOCUMENTS ON MICRO-ORGANISM.......................................................237
Section 1 Baculoviruses.........................................................................................................238
Section 2 Pseudomonas..........................................................................................................312
Section 3 Acidithiobacillus....................................................................................................394
LEAD COUNTRY AND PUBLISHED YEAR OF EACH CONSENSUS DOCUMENT......442
QUESTIONNAIRE TO RETURN TO THE OECD.................................................................443
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Table of Contents
Tables
Table 3.1 Summary of successful crosses with P. strobus..................................................15
Table 3.2 Species Interactions with Eastern White Pine....................................................20
Table 3.3 The taxonomy and distribution of the 44 species in the genus Betula.................46
Table 3.4 A summary of the results on seed germination in different crosses betwwen Betula
species .............................................................................................................................57
Table 3.5 Suggested classification, nomenclature and occurrence of Populus species and
synonyms given by an earlier classification...........................................................................104
Table 3.6 Nomenclature of naturally occurring Populus Hybrids.....................................106
Table 3.7 Species cross compatibility with Sitka spruce...................................................142
Table 3.8 Species Interactions with Sitka Spruce..............................................................148
Table 3.9 Stone fruit production, 1989-1999.....................................................................176
Table 3.10 Interspecific hybrids with Prunuspersica.........................................................190
Table 3.11 Hybrids of the sand cherries with other species................................................191
Table 3.12 Prunus species reported as hybrids between peach and peach species..............192
Table 3.13 Species cross compatibility with White Spruce.................................................216
Table 4.1 List of assigned baculovirus species..................................................................239
Table 4.2 Restriction maps of different nucleopolyhedroviruses and granuloviruses244Error!
Bookmark not defined.
Table 4.3 Insect host transposons found in baculovirus....................................................266
Table 4.4 Phylogeny and current classification of the pseudomonads316Error! Bookmark not
defined.
Table 4.5 Examples of plasmids responsible for the metabolism of organic compounds or
resistance to heavy metals in fluorescent Pseudomonas species...........................................319
Table 4.6 Examples of fluorescent species of Pseudomonas reported to have been used, or to have
potential use, for bioremediation............................................................................................327
Table 4.7 Examples of plasmids encoding for drug resistances in P. aeruginosa.............338
Table 4.8 Range of plant species susceptible to infection with P. syringue......................347
Table 4.9 Some toxins produced by phytopathogenic Pseudomonas spp.........................348
Table 4.10 Phytopathogenic strains of P. syringae containing plasmids352Error! Bookmark not
defined.
Table 4.11 Examples of identification and detection techniques.........................................356
Table 4.12 Acidithiobacillus : Characters used in classification.........................................396
Table 4.13 Genes in Acidithiobacillusferrooxidans............................................................405
Table 4.14 Comparative % solubilisation of heavy metals in sludge..................................411
Table 4.15 Usage and environmental impacts of Acidithiobacillus416Error! Bookmark not
defined.
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Table of Contents
Figures
Figure 3.1 The natural range of Eastern White Pine.........................................................12
Figure 3.2 The leaf, scale, seed, stem, buds and female and male catkins of Betula pendula
.........................................................................................................................47
Figure 3.3 The natural distribution of Betula pendula......................................................52
Figure 3.4 Crossability of Populus species.....................................................................112
Figure 3.5 The natural range of Sitka spruce..................................................................138
Figure 3.6 The natural range of White Spruce................................................................208
Figure 3.7 The reproductive cycle of White Spruce.......................................................210
Figure 4.1 Morphological characteristics of nucleopolyhedroviruses and granuloviruses...
.......................................................................................................................241
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