Table Of ContentHarmonisation of Regulatory Oversight in Biotechnology
Harmonisation of Regulatory Oversight
Safety Assessment of Transgenic Organisms
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information for use during the risk/safety assessment of transgenic organisms to be released in the o
environment, for agriculture, forestry or other purposes. The fi rst chapter deals with the low-level presence of f T in the Environment, Volume 6
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transgenic plants in seed and grain commodities and how this knowledge can be used in biosafety regulatory a
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assessment. The following chapters cover the biology of several crop species (sugarcane, cassava, common s
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bean and cowpea) and include elements of taxonomy, centres of origin, reproductive biology, genetics, e OECD CONSENSUS DOCUMENTS
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hybridisation and introgression, crop production and cultivation practices, interactions with other organisms ic
such as pests and pathogens, and biotechnological developments. The last chapter relates to the biology O
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of eucalyptus tree, focused on those species and hybrids which are planted commercially and might be the g
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subject of genetic modifi cation. This volume should be of value to applicants for commercial uses of transgenic n
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organisms, regulators and risk assessors in national authorities, as well as the wider scientifi c community. m
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Part I. Micro-organisms e
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Chapter 1. Low-level presence of transgenic plants in seed and grain commodities: environmental risk/safety n
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assessment and availability and use of information ir
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Consult this publication on line at http://dx.doi.org/10.1787/9789264253421-en. N
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Harmonisation of Regulatory Oversight in Biotechnology
Safety Assessment
of Transgenic Organisms
in the Environment,
Volume 6
OECD CONSENSUS DOCUMENTS
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FOREWORD –
Foreword
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.
The five main producers of genetically engineered crops in 2014 were the
United States, followed by Brazil, Argentina, India and Canada, covering together almost
90% of the total area. Interestingly, developing countries grew more of global transgenic
crops (53%) than industrial countries, at 47%. Among the 28 countries having planted
those crops in 2014, only 9 of them were OECD countries, listed by decreasing area as
follows: the United States, Canada, Australia, Mexico, Spain, Chile, Portugal, the
Czech Republic and the Slovak Republic. In addition, some countries do not grow
genetically engineered plants but import the produced commodities, for use in their feed
industry in particular, as it is the case in several jurisdictions of Europe as well as some
other economies worldwide.
Information on the transgenic crops which have been approved for commercial
release in at least one country (for use in agriculture and/or foods and feeds processing)
can be found in the OECD Biotrack Product Database (www2.oecd.org/biotech).
Each transgenic product and its Unique Identifier are described, with information on
approvals in countries. To date, this database covers about 240 approved genetically
engineered plant varieties, and will be extended in future years to include additional
species and information from a larger group of countries.
Modern biotechnologies are applied to plants, and also trees, animals and micro-
organisms. The safety of the resulting genetically engineered organisms when released in
the environment for their use in agriculture, food and feed industry, as biofuel or for other
applications represents a challenging issue.
This is already true nowdays with the increasing cultivation of transgenic crops.
It will be even more critical in the future as applications of biotechnologies widen to new
SAFETY ASSESSMENT OF TRANSGENIC ORGANISMS IN THE ENVIRONMENT: OECD CONSENSUS DOCUMENTS, VOLUME 6 © OECD 2016
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– FOREWORD
species and new areas: a growing number of novel organisms will have to be assessed
before their possible use and market release. Among the ongoing developments of
modern biotechnology, crop varieties modified for gaining adaptation features such as the
resistance to certain biotic/abiotic stresses, result in better resilience to climate change.
“Bio-fortification” (applied to rice, tuber crops and other species) develop varieties with
enhanced content in some constituents, e.g. vitamins or minerals. Plants with reduced
lignine or with increased oil content are examples of products sought to facilitate
industrial uses of the commodities and decrease the production costs. As highlighted in
the proceedings of the OECD Conference “Biosafety and the Environmental Uses of
Micro-organisms” held in 2012, a range of new species are contemplated as potential
biofuels to provide renewable energy; among them algaes, with photosynthetic
cyanobacteria, are of special interest as they can be cultivated year round on non-arable
land, alleviating the pressure on agricultural land and freshwater resources that would be
exerted by crops growng for biofuel purposes. Less anticipated, genetically engineered
mosquitos are used in few places since 2014 to control the insect population and fight
tropical diseases transmitted by them. Other biotechnology developments, and in
particular applied to micro-organisms, might lead to other products such biofertilizer
organisms living in symbiosis in crop roots and optimising the nitrogen fixation, or
biocontrol agents acting as plant protection products to control disease and attack by
insects. Other exploratory fields may comprise bioremediation by using of living
organisms for removing contaminants from the environment such as polluted land, or the
development of detergents containing micro-organisms.
Even if it is difficult to predict which of these new biotechnology developments
would lead to large applications in a medium term, it is expected that some of the
products will have important impacts in their respective economic sectors.
A scientifically sound approach to their risk assessment should inform biosafety
regulators and support the national decisions regarding their potential release. Genetically
engineered products are rigorously assessed by their developers during their elaboration,
and by governments when ready for commercial use, to ensure high safety standards for
the environment, human food and animal feed. Such assessments are felt essential for a
healthy and sustainable agriculture, industry and trade.
An environmental safety/risk assessment of transgenic organisms is normally 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 (the “Working Group”) 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 efforts. The biosafety consensus documents are one of
the major outputs of its work.
The biosafety consensus documents constitute 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 OECD
member countries believe are relevant to risk/safety assessment. Several non-member
economies, as well as other international organisations, are associated with the work and
share their expertise. The information collated in the consensus documents is said to be
mutually acceptable among the OECD community and beyond in other juridictions
wishing to use them during their assessment process.
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FOREWORD –
As of December 2015, a total of 53 consensus and guidance documents on biosafety
have been published by the Working Group. They include documents which address the
biology of plants, trees and micro-organisms as well as those dealing with specific traits
that are used in genetically engineered crops. In addition, documents of broader nature
aiming to facilitate harmonisati-on have been developed.
The volumes of this publication published in 2016 contain a compilation of those
biosafety consensus documents issued in 2011 and 2012 (Volume 5), and from 2013
to 2015 (Volume 6). Both of them contain the “Introduction to the biosafety consensus
documents” published earlier (and slightly updated since Volumes 3 and 4 of 2010).
The introduction explains the purpose of the 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.
Along with previous Volumes 1-4 (OECD, 2006a; 2006b; 2010a; 2010b) the present
publication offers ready access to those consensus documents published on the OECD
BioTrack website thus far. As such, Volumes 5 and 6 should be of value to applicants for
commercial uses of transgenic organisms, regulators in national authorities, breeders, risk
assessors as well as the wider scientific community.
This biosafety work is complementary of the activities of the OECD programme on
novel food and feed safety, in particular to the consensus documents developed on the
composition of foods and feeds derived from transgenic organisms, which detail the key
nutrients, anti-nutrients, toxicants and other constituents that can be used in a comparative
approach. More information on this programme can be found in the introduction.
As each of the consensus documents may be updated in the future when new
knowledge becomes available, users of this book are encouraged to provide any
information or opinions regarding the contents of the consensus documents or indeed, the
OECD’s other harmonisation activities. Comments can be provided to:
[email protected].
The published consensus documents are also available individually from the OECD’s
Biotrack website, at no cost (www.oecd.org/biotrack). Some updates have been made to
data and citations in this edition.
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– ACKNOWLEDGEMENTS
Acknowledgements
This book is the result of the common effort of the participants in the OECD’s
Working Group on Harmonisation of Regulatory Oversight in Biotechnology. Each
chapter is composed of a “consensus document” which was prepared under the leadership
of one or several countries and observer delegations, as listed at the end of this volume.
During their successive draftings, valuable inputs and suggestions for the documents were
provided by a number of delegates and experts in the Working Group, whether from
OECD member countries, non-member economies or observer organisations.
Each consensus document was issued individually, as soon as it was finalised and
agreed on declassification, by the OECD Environment, Health and Safety (EHS) Division
in the Series on Harmonisation of Regulatory Oversight in Biotechnology. Volumes 5
and 6 of this publication, containing the 2011-15 consensus documents, were prepared by
Jennifer Allain and edited by Bertrand Dagallier, under the supervision of Peter Kearns,
at the EHS Division, OECD Environment Directorate.
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TABLE OF CONTENTS –
Table of contents
Executive summary ................................................................................................................................. 13
Introduction to the biosafety consensus documents............................................................................. 15
About the OECD’s Working Group for biosafety ................................................................................. 15
Regulatory harmonisation ..................................................................................................................... 15
The need for harmonisation activities at the OECD .............................................................................. 16
Key background concepts and principles .............................................................................................. 16
A common approach to risk/safety assessment ..................................................................................... 16
The emergence of the concept of consensus documents ....................................................................... 17
The purpose of consensus documents ................................................................................................... 17
The process through which consensus documents are initiated and brought to publication ................. 18
Current and future trends in the Working Group .................................................................................. 19
The OECD Task Force for the Safety of Novel Foods and Feeds ........................................................ 20
Notes ..................................................................................................................................................... 21
Annex: OECD biosafety principles and concepts developed prior to the Working Group
on Harmonisation of Regulatory Oversight in Biotechnology (1986-94) .............................. 22
References and additional reading ........................................................................................................ 24
Part I: Facilitating harmonised safety assessments ............................................................................. 27
Chapter 1. Low-level presence of transgenic plants in seed and grain commodities:
Environmental risk/safety assessment and availability and use of information ................ 27
Foreword ............................................................................................................................................... 30
Preamble ................................................................................................................................................ 30
Executive summary ............................................................................................................................... 32
Introduction ........................................................................................................................................... 38
Purpose and scope ................................................................................................................................. 39
Information availability, information use and environmental risk/safety assessment in
low-level presence situations ................................................................................................................ 41
Use of information and an environmental risk/safety assessment for management of
low-level presence situations in seed .................................................................................................... 57
Notes ..................................................................................................................................................... 61
Annex 1.A1. Questionnaire on LLP situations and country responses ................................................. 62
References ............................................................................................................................................. 63
Part II: Biology of crops ......................................................................................................................... 67
Chapter 2. Sugarcane (Saccharum spp.) ................................................................................................ 67
Introduction and uses ............................................................................................................................ 70
Taxonomy of species ............................................................................................................................. 74
Origin and cultivation ............................................................................................................................ 76
Morphology ........................................................................................................................................... 91
Development ......................................................................................................................................... 94
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Genetics ................................................................................................................................................. 98
Abiotic interactions ............................................................................................................................... 98
Biotic interactions ............................................................................................................................... 102
Weediness............................................................................................................................................ 112
Hybridisation ....................................................................................................................................... 113
Health and biosafety ............................................................................................................................ 119
Notes ................................................................................................................................................... 120
Annex 2.A1. Major invertebrate pests of sugarcane and their control ................................................ 121
Annex 2.A2. Major diseases of sugarcane .......................................................................................... 123
References ........................................................................................................................................... 124
Chapter 3. Cassava (Manihot esculenta) .............................................................................................. 155
Species or taxonomic group ................................................................................................................ 156
Geographic distribution, ecosystems and habitats, cultivation and management practices,
centres of origin and diversity ............................................................................................................. 158
Reproductive biology .......................................................................................................................... 165
Genetics ............................................................................................................................................... 169
Hybridisation and introgression .......................................................................................................... 170
Plant developmental stages ................................................................................................................. 172
General interactions with other organisms .......................................................................................... 173
Annex 3.A1. Common pests and pathogens ........................................................................................ 174
Annex 3.A2. Biotechnological developments ..................................................................................... 177
References ........................................................................................................................................... 180
Chapter 4. Common bean (Phaseolus vulgaris) .................................................................................. 187
Species or taxonomic group ................................................................................................................ 188
Reproductive biology .......................................................................................................................... 195
Genetics ............................................................................................................................................... 197
Hybridisation and introgression .......................................................................................................... 197
General interactions with other organisms (ecology) .......................................................................... 198
Human health ...................................................................................................................................... 199
Annex 4.A1. Common pests and pathogens ........................................................................................ 200
Annex 4.A2. Biotechnological developments ..................................................................................... 204
References ........................................................................................................................................... 205
Chapter 5. Cowpea (Vigna unguiculata) .............................................................................................. 211
Introduction ......................................................................................................................................... 212
Species or taxonomic group ................................................................................................................ 212
Geographic distribution, habitats, crop production, centres of origin and diversity ........................... 215
Reproductive biology .......................................................................................................................... 220
Genetics and genome mapping............................................................................................................ 223
Species/subspecies hybridisation and introgression ............................................................................ 223
General interactions with other organisms (ecology) .......................................................................... 224
Human health and biosafety ................................................................................................................ 225
Annex 5.A1. Common pests and pathogens ........................................................................................ 227
Annex 5.A2. Biotechnological developments ..................................................................................... 231
References ........................................................................................................................................... 234
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