Safety assessment of foods and feeds derived from transgenic crops. 2 ...

274 Pages·2015·4.662 MB·English

by  OECD

Novel Food and Feed Safety N
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Safety Assessment of Foods and Feeds Derived l F Novel Food and Feed Safety
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from Transgenic Crops o
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n Safety Assessment
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d of Foods and Feeds Derived
Volume II of this series compiles the science-based consensus documents of the OECD Task Force for the S
Safety of Novel Foods and Feeds from 2009 to 2014. They contain information for use during the regulatory a
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assessment of food/feed products of modern biotechnology, i.e. developed from transgenic crops. Relevant ty from Transgenic Crops
information includes compositional considerations (nutrients, anti-nutrients, toxicants, allergens), use of the
plant species as food/feed, key products and components suggested for analysis of new varieties for food use
and for feed use, and other elements. These documents should be of value to applicants for commercial uses Volume 2
of novel foods and feeds, regulators and risk assessors in national authorities for their comparative approach,
as well as the wider scientific community.
S
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Contents fe
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Part I. Towards harmonised assessments of food and feed safety A
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Chapter 1. Molecular characterisation of plants derived from modern biotechnology e
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Part II. Compositional considerations for transgenic crops m
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Chapter 2. Cotton (Gossypium hirsutum and G. barbadense) n
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Chapter 3. Cassava (Manihot esculenta) f
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Chapter 4. Grain sorghum (Sorghum bicolor) o
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Chapter 5. Sweet potato (Ipomoea batatas) s
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Chapter 6. Papaya (Carica papaya) n
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Chapter 7. Sugarcane (Saccharum ssp. hybrids) F
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Chapter 8. Low erucic acid rapeseed (canola) d
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Chapter 9. Soybean (Glycine max) D
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Chapter 10. Oyster mushroom (Pleurotus ostreatus) r
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Consult this publication on line at http://dx.doi.org/10.1787/9789264180338-en.
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ISbN 978-92-64-18032-1
9HSTCQE*biadcb+
97 2012 12 1 P

Novel Food and Feed Safety
Safety Assessment of
Foods and Feeds Derived
from Transgenic Crops,
Volume 2
ThisworkispublishedundertheresponsibilityoftheSecretary-GeneraloftheOECD.The
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Pleasecitethispublicationas:
OECD(2015),SafetyAssessmentofFoodsandFeedsDerivedfromTransgenicCrops,Volume2,NovelFood
andFeedSafety,OECDPublishing,Paris.
http://dx.doi.org/10.1787/9789264180338-en
ISBN978-92-64-18032-1(print)
ISBN978-92-64-18033-8(PDF)
Series:NovelFoodandFeedSafety
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ISSN2304-9502(online)
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3
FOREWORD –

Foreword
From their first commercialisation in the mid-1990s, genetically engineered crops
(also known as transgenic crops) have been increasingly approved for cultivation, and
for entering in the composition of foods or feeds, by a number of countries. To date,
genetically engineered varieties of over 25 different plant species (including agricultural
crops, flowers and trees) have received regulatory approvals in OECD and non-OECD
countries from all regions of the world. Up to now, the large majority of plantings remain
for soybean, maize, cotton and rapeseed (canola), as outlined in the OECD’s
The Bioeconomy to 2030: Designing a Policy Agenda. Over the 19-year period from 1996
to 2014, the surface area grown with transgenic crops worldwide has constantly raised,
resulting in a significant increase of their harvested commodities used in foods and feeds
(often designated as “novel” foods and feeds). This is highlighted in analyses and
statistics from several sources which, despite some differences in total estimates,
all concur in underlining the general increasing trend in volumes produced, number of
countries involved and growth potential.
For instance, James reports in the Global Status of Commercialized Biotech/GM
Crops: 2014 a record 181.5 million hectares of genetically engineered plants grown,
representing an annual growth rate of more than 3.5% from 2013. According to this
study, the five main producers 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 transgenic 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. However, an additional group of countries does not produce
transgenic crops but imports 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 of these transgenic crops which have been approved for commercial
release in at least one country (for planting and/or for use in 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, as well as information on
approvals in countries.
In parallel to the expansion of genetically engineered crops developed for their
resistance to pests and diseases, varieties are being developed by breeders for new types
of traits: adaption to climate change, improved composition (biofortification), enhanced
meat productivity, easier processing and many other applications. The range of
biotechnology applications to agricultural plant breeding is widening, and it seems that
the trend will continue. Consequently, the volume of novel foods and feeds available
on the market and exchanged internationally is expected to increase in the coming years.
SAFETY ASSESSMENT OF FOODS AND FEEDS DERIVED FROM TRANSGENIC CROPS, VOLUME II © OECD 2015
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– FOREWORD

Consumers from all over the world are requiring a high level of safety and
full confidence in the products they eat. This is particularly important for the products of
modern biotechnology, which are sometimes questioned and subject to diverse levels of
acceptation among countries. The approvals of transgenic crops follow a science-based
risk/safety assessment regarding their potential release in the environment (biosafety)
and their use in foods or feeds (novel food and feed safety). The OECD has undertaken
activities related to environmental safety aspects since the mid-1980s, while
the development of scientific principles for food safety assessment was initiated in 1990.
The OECD helps countries in their risk/safety assessment of transgenic organisms
by offering national authorities a platform to exchange experience on these issues,
identify emerging needs, collate solid information and data, and develop useful tools
for risk assessors and evaluators.
To date, 26 consensus documents relating to the safety of novel foods and feeds
have been published; 2 have been revised 10 years later. Most of these publications
address compositional considerations of crops subject to plant breeding improvement
with modern biotechnologies. These consensus documents are focused on key food and
feed nutrients, anti-nutrients, toxicants and other constituents as relevant. They provide
solid information commonly recognised by experts and collate the reliable range of data
available in the scientific literature at the time of the publication. They can be used
in the comparative approach to safety assessment. In addition, documents of a broader
nature aiming to facilitate harmonisation have been developed: animal feedstuffs derived
from transgenic commodities (2003), designation of an OECD “Unique Identifier”
for transgenic plants (2002, revised in 2006) and molecular characterisation of transgenic
plants (2010).
Volumes I and II of this series compile the consensus documents of the OECD Series
on Safety of Novel Foods and Feeds issued since 2002 (Volume I covers 2002-08,
Volume II covers 2009-14). The presentation of the OECD work, originally published
in 2006, was used as a basis for the introduction section that explains the purpose of
the consensus documents, their relevance to risk/safety assessment and their preparation
by the relevant OECD task force. The present compendium offers ready access
to those documents which have been published thus far. As such, it should be of value to
applicants for uses of transgenic crop commodities in foods and feeds, regulators and
risk/safety assessors in national authorities, as well as to the wider scientific community.
Each of the consensus documents may be updated in the future as new knowledge
becomes available. Users of this book are therefore encouraged to provide information or
an opinion regarding the contents of the consensus documents or any of 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.
SAFETY ASSESSMENT OF FOODS AND FEEDS DERIVED FROM TRANSGENIC CROPS, VOLUME II © OECD 2015
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ACKNOWLEDGEMENTS –

Acknowledgements
This book results from the common effort of the participants in the OECD’s
Task Force for the Safety of Novel Foods and Feeds. Each chapter is composed of
a “consensus document” which was prepared under the leadership of a participating
country or several countries, as listed at the end of this volume. During their successive
drafting, valuable inputs and suggestions for the documents were provided by a number
of delegates and experts in the Task Force, 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 for declassification, by the OECD Environment, Health and Safety Division
in the Series on Safety of Novel Foods and Feeds. The manuscripts of Volumes I and II
of this publication, containing the 2002-14 consensus documents, were prepared
by Elisabeth Huggard, Arely Badillo, Carolina Tronco-Valencia and Jennifer Allain.
They were edited by Bertrand Dagallier, under the supervision of Peter Kearns,
at the Environment, Health and Safety Division of the OECD Environment Directorate.
SAFETY ASSESSMENT OF FOODS AND FEEDS DERIVED FROM TRANSGENIC CROPS, VOLUME II © OECD 2015

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TABLE OF CONTENTS –

Table of contents
Executive summary ...................................................................................................................... 13
Introduction .................................................................................................................................. 15
Part I Towards harmonised assessments of food and feed safety ............................................ 21
Chapter 1 Molecular characterisation of plants derived from modern biotechnology .......... 23
Introduction ................................................................................................................................ 24
Background ................................................................................................................................ 24
Transformation methods ............................................................................................................ 27
Inserted DNA, the insertion site and expressed material ........................................................... 29
Inheritance and genetic stability ................................................................................................. 32
Summary .................................................................................................................................... 34
Notes .......................................................................................................................................... 34
References .................................................................................................................................. 35
Part II Compositional considerations for transgenic crops ..................................................... 37
Chapter 2 Cotton (Gossypium hirsutum and G. barbadense) .................................................... 39
Introduction ................................................................................................................................ 40
Background ................................................................................................................................ 40
Nutrients in whole cottonseed and cottonseed products ............................................................. 43
Anti-nutrients in cotton .............................................................................................................. 49
Food use ..................................................................................................................................... 50
Feed use ...................................................................................................................................... 51
References .................................................................................................................................. 53
Chapter 3 Cassava (Manihot esculenta) ...................................................................................... 57
Background ................................................................................................................................ 58
Nutrients ..................................................................................................................................... 66
Other constituents ....................................................................................................................... 77
Suggested constituents to be analysed related to food use ......................................................... 81
Suggested constituents to be analysed related to feed use ......................................................... 83
Note ............................................................................................................................................ 85
References .................................................................................................................................. 86
Chapter 4 Grain sorghum (Sorghum bicolor) ............................................................................ 93
Background ................................................................................................................................ 94
Nutrients ................................................................................................................................... 100
Anti-nutrients ........................................................................................................................... 105
Suggested constituents to be analysed related to food use ....................................................... 107
SAFETY ASSESSMENT OF FOODS AND FEEDS DERIVED FROM TRANSGENIC CROPS, VOLUME II © OECD 2015
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– TABLE OF CONTENTS

Suggested constituents to be analysed related to feed use ....................................................... 109
Note .......................................................................................................................................... 111
References ................................................................................................................................ 111
Chapter 5 Sweet potato (Ipomoea batatas) ............................................................................... 115
Background .............................................................................................................................. 116
Nutrients ................................................................................................................................... 121
Other constituents ..................................................................................................................... 126
Suggested constituents to be analysed related to food use ....................................................... 128
Suggested constituents to be analysed related to feed use ....................................................... 130
Notes ........................................................................................................................................ 131
References ................................................................................................................................ 131
Chapter 6 Papaya (Carica papaya) ............................................................................................ 135
Background .............................................................................................................................. 136
Nutrients ................................................................................................................................... 142
Other constituents ..................................................................................................................... 149
Suggested constituents to be analysed related to food use ....................................................... 151
Suggested constituents to be analysed related to feed use ....................................................... 152
Note .......................................................................................................................................... 153
References ................................................................................................................................ 153
Chapter 7 Sugarcane (Saccharum ssp. hybrids) ...................................................................... 159
Background .............................................................................................................................. 160
Nutrients ................................................................................................................................... 168
Other constituents ..................................................................................................................... 174
Suggested constituents to be analysed related to food use ....................................................... 175
Suggested constituents to be analysed related to feed use ....................................................... 176
Notes ........................................................................................................................................ 178
References ................................................................................................................................ 178
Chapter 8 Low erucic acid rapeseed (canola) .......................................................................... 183
Background .............................................................................................................................. 184
Nutrients ................................................................................................................................... 192
Other constituents ..................................................................................................................... 198
Suggested constituents to be analysed related to food use ....................................................... 200
Suggested constituents to be analysed related to feed use ....................................................... 202
Notes ........................................................................................................................................ 203
References ................................................................................................................................ 204
Chapter 9 Soybean (Glycine max) ............................................................................................. 209
Background .............................................................................................................................. 210
Nutrients ................................................................................................................................... 213
Other constituents ..................................................................................................................... 222
Suggested constituents to be analysed related to food use ....................................................... 228
Suggested constituents to be analysed related to feed use ....................................................... 230
Notes ........................................................................................................................................ 232
References ................................................................................................................................ 233

SAFETY ASSESSMENT OF FOODS AND FEEDS DERIVED FROM TRANSGENIC CROPS, VOLUME II © OECD 2015