Safety Assessment of Genetically Modified Foods

262 Pages·2017·2.019 MB·English

by  Kunlun Huang (auth.)

Kunlun Huang
Safety
Assessment
of Genetically
Modifi ed Foods
Safety Assessment of Genetically Modified Foods
Kunlun Huang
Safety Assessment of
Genetically Modified Foods
Kunlun Huang
College of Food Science and Nutritional
Engineering
China Agricultural University
Beijing, Beijing, China
ISBN 978-981-10-3487-9 ISBN 978-981-10-3488-6 (eBook)
DOI 10.1007/978-981-10-3488-6
Library of Congress Control Number: 2017939578
© Springer Nature Singapore Pte Ltd. 2017
This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of
the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation,
broadcasting, reproduction on microfilms or in any other physical way, and transmission or information
storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology
now known or hereafter developed.
The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication
does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
protective laws and regulations and therefore free for general use.
The publisher, the authors and the editors are safe to assume that the advice and information in this book
are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the
editors give a warranty, express or implied, with respect to the material contained herein or for any errors
or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims
in published maps and institutional affiliations.
Printed on acid-free paper
This Springer imprint is published by Springer Nature
The registered company is Springer Nature Singapore Pte Ltd.
The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721,
Singapore
Contents
1 Introduction ............................................................................................... 1
1.1 Generation, Development and Appliance of Genetically
Modified Organisms (GMOs) in the World ....................................... 1
1.2 The Production and Development of GM Crops
and Its Planting Situation Throughout the World .............................. 3
1.2.1 Global Distribution of Genetically Engineered
Crops, by Crop .................................................................... 3
1.2.2 Two Types of Flowers ......................................................... 5
1.2.3 Global Distribution of Genetically Engineered Crops,
by Counties .......................................................................... 5
1.3 T he Main GMOs Cultivate Around the World................................... 6
1.4 The Issues of Safety of GMOs ........................................................... 8
1.5 The Principle and Content of Safety Assessment for Genetically
Modified Food.................................................................................... 9
1.5.1 Scientific Research .............................................................. 10
1.5.2 Concept of Substantial Equivalence .................................... 10
1.5.3 Precaution ............................................................................ 10
1.5.4 Case-by-Case Basis ............................................................. 10
1.5.5 Step-by-Step Evaluation ...................................................... 11
1.6 Concept of Familiarity ....................................................................... 11
Part I
2 Nutrient Assessment of GMOs ................................................................. 15
2.1 Nutritional Components Analysis of GMOs ...................................... 16
2.1.1 Contents of Nutritional Components Analysis of GMOs .... 16
2.1.2 Nutritional Components Analysis of GMOs ....................... 18
2.1.3 Research Review of Nutritional Evaluation of 
Common GM Crops ............................................................ 25
2.2 Anti-nutritional Factors...................................................................... 45
2.2.1 Anti-nutrients in Rice .......................................................... 46
v
vi Contents
2.2.2 Anti-Nutrients in Soybean ................................................... 48
2.2.3 Anti-Nutrients in Other Crops ............................................. 48
2.3 Nutrient Use Efficiency...................................................................... 49
2.3.1 Present Studies on Nutrient Use Efficiency ......................... 50
2.3.2 P rotein Efficiency Ratio, PER ............................................. 51
2.4 Nutritional Evaluation for GMOs Using Animals ............................. 53
2.4.1 Poultry ................................................................................. 54
2.4.2 Pig ........................................................................................ 55
2.4.3 Sheep ................................................................................... 56
2.4.4 Cattle ................................................................................... 56
2.5 Perspective of Nutrient Assessment of GMOs................................... 57
2.5.1 GM Crops with Additional Healthful Nutrients .................. 58
2.5.2 G enetically Modified Crops with Lower Concentrations
of Toxins .............................................................................. 59
2.5.3 Industrial and Pharmaceutical Genetically Modified
Organisms ............................................................................ 61
2.5.4 Future Challenges of Nutrient Assessment for GMOs ........ 61
3 O verviews of Food Allergy and Evaluating Methods Used
in Allergenic Assessment of GMOs with Application
Examples Conducted in Our Laboratory ............................................... 63
3.1 The Background of Food Allergy, Allergenic Worries
in GMOs, and the Decision-Tree Approach to Evaluate
the Allergenicity of Genetically Modified Foods .............................. 63
3.1.1 Food Allergy ........................................................................ 63
3.1.2 Overview of GMOs ............................................................. 64
3.1.3 Decision-Tree Approach to the Evaluation
of the Allergenicity of Genetically Modified Foods............ 65
3.1.4 Standardization of Methodologies....................................... 67
3.2 In Vitro Evaluation Method Used in Allergenic Assessment
of GMOs and Several Application Examples in Different
Aspects Conducted in Our Laboratory .............................................. 69
3.2.1 Bioinformatic Analysis ........................................................ 69
3.2.2 Serum Screening.................................................................. 82
3.2.3 Simulated Gastric Digestion and Heat Stability .................. 87
3.2.4 Cell Models ......................................................................... 93
3.3 In Vivo Evaluation Method Used in Allergenic Assessment
of GMOs and Several Application Examples in Different
Aspects Conducted in Our Lab .......................................................... 100
3.3.1 Animal Models .................................................................... 100
3.3.2 Human Trials ....................................................................... 116
3.4 The Prospect of Allergenic Assessment of GMOs
and the Future Development Trend of Evaluating
Methods Used in Allergenic Assessment of GMOs .......................... 116
Contents vii
4 Toxicology Assessment .............................................................................. 119
4.1 Toxicology Assessment Used in Safety Assessment
of GMOs and the Methods Used in Food Safety
Assessment, with the Advantage and Disadvantage
of Methods In Vivo and In Vitro ........................................................ 119
4.1.1 Toxicology Assessment Used in the Safety
Assessment of GMOs .......................................................... 119
4.1.2 The Methods Used in Food Safety Assessment,
and the Advantages or Disadvantages
of Methods In Vivo and In Vitro ......................................... 120
4.2 Animal Tests Used in the Safety Assessment of GMOs
and the Application of Animal Tests in Toxicology Research .......... 121
4.2.1 Animal Tests Used in the Safety Assessment
of GMOs .............................................................................. 121
4.2.2 Species Selection ................................................................. 122
4.2.3 Dose Selection ..................................................................... 122
4.2.4 Route of Administration ...................................................... 122
4.3 The Expression of Foreign Protein (the Exogenous
Gene in GMOs) and Equality in In Vitro Analysis ............................ 123
4.3.1 The Expression of Foreign Protein ...................................... 123
4.3.2 The Substantial Equivalence of Protein Expression ............ 133
4.4 Acute Oral Toxicity of Foreign Protein ............................................. 135
4.5 Sub-chronic Toxicology Assessment of Whole GM
Food or Feed in Animals In Vivo ...................................................... 141
4.5.1 Materials and Procedure ...................................................... 143
4.5.2 Plant Materials ..................................................................... 143
4.5.3 Diet Formulation and Experimental Design ........................ 143
4.5.4 Animals and Management ................................................... 144
4.5.5 C linical Observation, Body Weight Gain,
and Feed Utilization ............................................................ 144
4.5.6 Hematology ......................................................................... 145
4.5.7 Serum Chemistry ................................................................. 145
4.5.8 Necropsy and Histopathology ............................................. 145
4.5.9 Statistical Analysis .............................................................. 146
4.5.10 Examples ............................................................................. 146
4.6 Chronic Toxicology Study of Whole GM Foods
or Feed in Animals In Vivo ................................................................ 159
4.7 Prospect: Safety Assessment of Toxicology in the Future ................. 163
4.7.1 The Protocols for the Safety Assessment
of GMOs Come from the Protocols for Chemicals:
These Studies Have Limitations for the Testing
of Whole Foods and Feed .................................................... 163
4.7.2 The Development of Alternative Testing to Animal
Experiments ......................................................................... 163
viii Contents
5 Human Trials ............................................................................................. 165
5.1 The Debate on the Necessary of Human Trials on GM Foods .......... 165
5.1.1 C an Animal Tests and In Vitro Cell Tests Reflect
the Safety of GM Foods? ..................................................... 165
5.1.2 The Debate of Human Trials for GM Foods ....................... 166
5.2 The Principles and Requirements of Human Trials ........................... 167
5.2.1 What Is a Science-Based Human Trial? .............................. 167
5.2.2 The Protocol Consideration of a Human Trial .................... 168
5.3 The Application of Human Trials on GM Foods ............................... 169
5.3.1 Food Allergenic Assessment................................................ 169
5.3.2 Nutritional Study on Nutritionally Improved
GM Foods ............................................................................ 171
5.3.3 Horizontal Gene Transfer Study on GM Food .................... 173
5.3.4 Epidemiological Investigation and Post-marketing
Surveillance of GM Foods................................................... 175
5.4 Conclusion ......................................................................................... 177
Part II
6 N ew Technology Used in GMO Safety Assessment ................................ 181
6.1 The Definition of Unintended Effects ................................................ 181
6.2 Why Unintended Effects Happen? .................................................... 183
6.3 Characters of Unintended Effects of Genetically
Modified Organisms .......................................................................... 183
6.3.1 Change of Targeted Phenotypic Characters ........................ 183
6.3.2 Change of Targeted Hereditary Characters ......................... 184
6.3.3 Variations of Nontargeted Characters .................................. 184
6.3.4 Gene Horizontal Transfer .................................................... 184
6.4 Assessment Criteria of Unintended Effects of Genetically
Modified Organisms .......................................................................... 185
6.5 Detection Approaches for Unintended Effects of GMOs .................. 186
6.5.1 Targeted Methods ................................................................ 186
6.5.2 Nontargeted Approaches ..................................................... 191
6.5.3 Functional Genome Detection ............................................. 192
6.5.4 Transcriptome Detection ..................................................... 192
6.5.5 Proteomics Detection .......................................................... 193
6.5.6 Metabolome Detection ........................................................ 195
6.5.7 Gut Health ........................................................................... 199
6.6 Conclusion ......................................................................................... 206
7 S afety Assessment of Transgenic Microbiology ...................................... 207
7.1 Definition of Transgenic Microorganism ........................................... 207
7.2 Outline of Transgenic Microorganism ............................................... 207
7.2.1 Background of the Use of Microorganisms in Food ........... 207
Contents ix
7.3 Transgenic Technology in Microorganisms Used in Food Industry .. 209
7.3.1 Bacterial Starter Cultures .................................................... 209
7.3.2 Yeasts and Filamentous Fungi ............................................. 210
7.4 Potential Impact of Food-Associated GMMs on Human Body ......... 211
7.4.1 Interactions with Human Microbiota .................................. 211
7.4.2 Gene Transfer Between Food-Related
and Intestinal Microbes ....................................................... 213
7.5 Regulatory Aspects ............................................................................ 214
7.6 Methods of Safety Evaluation of Food-Related GMMs .................... 214
7.6.1 General Principles to Determine Risks
and Benefits ......................................................................... 214
7.6.2 Viable GMMs in Foods ....................................................... 215
7.7 Researches on Food Safety of Transgenic Microorganism ............... 216
7.7.1 F ood Safety of Transgenic Microorganism
in Some Laboratories........................................................... 216
7.7.2 Food Safety of Transgenic Microorganism
in Our Laboratory ................................................................ 217
7.8 Prospects ............................................................................................ 227
References ........................................................................................................ 229
Chapter 1
Introduction
1.1 Generation, Development and Appliance of Genetically
Modified Organisms (GMOs) in the World
Nowadays, genetic modification (GM) technology was widely applied into many
biology fields. It provides a method to introduce exogenous DNA into the targeted
creatures such as batteries, yeasts, plants, and animals, ensuring a specific charac-
teristic existed into the targets. Meanwhile, food issues affect the economy and the
livelihood of various countries, and they also affect global development and secu-
rity. GM crops can be a solution of this problem, because they are modified to con-
tain useful characteristics. Some GM crops are being developed in tolerance of
herbicide or insect, and other crops contain new genes that have improved nutri-
tional characteristics for feed or food use. It is no wonder that these modified crops
provide more production and can also save our manpower and material resources.
This is the reason why GM crops are now applied widely in among 30 countries,
making prosperity and development worldwide. Until now, there are many com-
mercial GM crop species including corn, cotton, soybean, canola, and papaya, and
they have been grown in hectarage of nearly more than 1.8 million hectares, which
was a remarkable 100-fold increase since the start of commercialization in the year
of 1996.
However, there also come some notable concerns on the safety of GM crops
which mainly focus on the risk to human health and environment. And the media
and public are often confused by some unreliable reports, which make the spread of
GM crops suffering from a difficult procedure. In fact, before the GM crops will be
put on the market, we must make sure that the crops have passed through the safety
assessment by national authorities.
Even though the safety assessments of the GM crops differ from countries and
authorities, the basic framework and procedure are quite closer to agreements. The
safety assessments of GM crops are known to be complex of the subject, including
the feeding strategies and periods, animal models (fish, chicken, mice, rat, and pig
© Springer Nature Singapore Pte Ltd. 2017 1
K. Huang, Safety Assessment of Genetically Modified Foods,
DOI 10.1007/978-981-10-3488-6_1