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Contents
Introduction 1
Chapter 1 Molecular Basis of Genetic Engineering 18
1.1 The concept and structure of gene 18
1.2 DNA replication 20
1.3 DNA transcription and its regulation 23
1.4 Post-transcription processing and regulation of RNA 24
1.5 Protein expression and its regulation 28
1.6 Restriction endonuclease 30
Chapter 2 Principles and Applications of Genetic Engineering 32
2.1 Important events in the history of the development of recombination DNA 32
2.2 Isolation of target genes 34
2.3 Recombinant 35
2.4 Vectors for genetic engineering 37
2.5 Plant transformation methods 39
2.6 Methods of developing transgenic animals 42
2.7 General process of GMO research and development 44
Chapter 3 Development of Transgenic Biotechnology 45
3.1 Development of transgenic plants 45
3.2 Studies of transgenic animals 49
3.3 The researches on genetically modified microbes 63
3.4 Genetic engineering vaccine 70
Chapter 4 Potential Health Risks from Genetically Modified Organisms 76
4.1 Commercial production status of genetically modified food 77
4.2 The exposure of DNA 79
4.3 Potential risks of GM food to health 82
4.4 The scheme of risk assessment of genetically modified food 87
Chapter 5 The Potential Ecological Risk of Genetically Modified Organisms 90
5.1 Impact of GMOs on the ecological environment 90
5.2 Horizontal gene flow – biosafety concern for recombinant DNA 95
5.3 Vertical gene flow - theoretical foundation of alien gene escape 98
Chapter 6 Risk Assessment of GMO: Methods and Cases 110
6.1 Principle and methods of genetically modified organisms risk assessment 110
6.2 Risk assessment of the genetically modified crops 113
6.3 Risk assessment of the genetically modified food crops 121
6.4 Risk assessment of the genetically modified forests 126
6.5 Risk assessment of the genetically modified microorganism 128
Chapter 7 Risk Management for GMOs 129
7.1 The defi nition, goals and requirements of risk management 129
7.2 The theoretic foundation on GMOs risk management—Scientifi c Uncertainty 130
7.3 Principle of risk management——Precautionary principle 133
7.4 Practice of GMOs management——take EU as an example 139
Chapter 8 Detection and Monitoring of Transgenes 143
8.1 The signifi cance and necessity of detection and monitoring of transgenes 143
8.2 Detective methods of transgenes 144
8.3 Immunology analysis of the proteins in GMOs 153
8.4 The detection method of transgenic microorganisms 155
8.5 The uniform standards of the GMO detection experiment 156
8.6 Environment monitoring of GMOs 158
Chapter 9 Biosafety International Law: Cartagena Protocol on Biosafety 165
9.1 The background of the Protocol 166
9.2 The basic principles of biosafety protocol 169
9.3 Main contents of biosafety protocol 173
9.4 The negotiation progress after Biosafety Protocol 181
Chapter 10 Biosafety Legislations in Some Countries 192
10.1 Biosafety legislation in European Union 192
10.2 Biosafety legislation in the United States 198
10.3 Biosafety legislation in Japan 201
10.4 Biosafety legislation in India 206
10.5 Biosafety legislation in Brazil 211
10.6 Biosafety legislation in Australia 214
Chapter 11 Framework of China’s Biosafety Policies, Regulations and System 217
11.1 Policy framework of biosafety in China 217
11.2 Current laws and regulations on GMO biosafety in China 224
11.3 Management system and implementation procedures of GMOs 244
Chapter 12 Transboundary Movements and Labeling of Living Modified Organisms (LMOs) 254
12.1 Main contents of transboundary movements of LMOs 255
12.2 Negotiation process of transboundary movements of LMOs in the Protocol 257
12.3 Labeling requirements of LMOs and international tendency 264
12.4 Labeling of GMO in China 271
Chapter 13 Damage Liability and Redress in Biosafety Law 279
13.1 Principles and mechanisms of international environmental damages legislation 279
13.2 International negotiations on biosafety damage liability and redress 281
13.3 Proposed principles of international biosafety damages legislation 286
13.4 Proposed mechanisms in international biosafety damages legislation 288
13.5 Biosafety damages legislation of some countries and regions 291
13.6 China’s legislation on biosafety damages and its impacts 293
Chapter 14 Socio-Economic Impacts of GMOs 298
14.1 Attention by the international society to the socio-economic impacts of GM crops 298
14.2 Types of social—economic impact of GMOs 304
14.3 Relationship between Biosafety Protocol and TWO 311
14.4 Possible Impact of Safety Management on the International Trade 317
Chapter 15 Emergency Management for Biosafety 329
15.1 Theoretical analysis 329
15.2 International law and the management of GMOs 331
15.3 National laws 335
15.4 Emergency management of GMOs safety in China 338
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Introduction
The 21st century is the century of biology, and fruitful achievements and great successes have been gained in various .elds of biological research, development, and application. The rapid progress in biotechnological research and its results have been rapidly applied to all .elds of life sciences. For example, the use of somatic cell cultural and transgenic technology for genetic improvement of crop varieties; the use of bacterial fermentation technology for biology pharmacy; deciphering of important plant and animal genome; and the breakthrough in animal cloning technologies and the resulted clone sheep, clone cows, and clone pigs, etc.; all of the above have brought enormous opportunities for the improvement of human survival and life quality. Especially since early 1970s, the establishment of recombinant DNA technology and the subsequent rapid development of transgenic technology have played, and will continue to play, a key role in .elds of agriculture, forestry, .sheries, medicine, light industry and environmental protection, etc. Many people believe that biotechnology will be one of the ten key-technologies for high-tech development in the next few years. Some even consider the biotechnology, particularly GM technology as key technology to solve the food security problems for developing countries in the 21st century. The great breakthrough and contribution of biotechnology including transgenic technology let people feel that they may solve the problems by themselves, and human have the ability to change the nature!
1. The safety issues of transgenic technology and biosafety conception
1) The safety issues of transgenic technology
As we all know, science is a ruthless “double-edged sword”, while human is immersed in the surprises of a series of biological research and extensive great breakthroughs and achievements in the century of biology, there occurs a series of biosafety problems in biology .eld which alarm human, such as the invasion and madly outburst of alien species; the erosion of biodiversity; the transmission and adverse effects of transnational livestock diseases (such as the avian .u, mad cow disease and aftosa) on human; and the reports on the unsafe possibility of GM crops or GM food, etc. Does biotechnology, especially recombinant DNA and transgenic technology have potential danger? Are genetically modi.ed products safe and reliable? With a variety of lab-research achievements of GM crops released from the laboratory to the environment one after another, conducting .eld experiment and even large-scale environmental release and commercial production, and .nally getting into the commercial markets and onto the family’s table, skeptical or even opposite voices on GM crops are arising increasingly around the world. People in many countries and some non-governmental organizations (e.g. Greenpeace) are extremely dissatis.ed with the research, production and commercialization of biotechnology products, and there arise many protests, marches or boycotts on biotechnology products constantly. People are increasingly concerned at biosafety, and biosafety issues become the focus of international contention for a time. Then, what is biosafety? How do biosafety issues come out? What are the main contents that biosafety involved? What is the meaning of understanding of biosafety? These are all questions that very interesting and worthy of clari.cation.
2) The broad conception of biosafety
Biosafety may be one of the most frequent vocabulary related to biology appeared in the modern media. As the name implies biosafety must be related to biology and safety. Then, what is biosafety? Which subjects are biosafety related to? Only when understanding the de.nition biosafety, we may further understand the content it relates to, and what does it research. Biosafety has broad and narrow de.nitions, broad biosafety refers to “In a certain time and space, exotic species immigrant because of natural or human activities, and thus change and harm the other local species and ecosystems; human-induced intense changes in the environment and its impact and threat on biodiversity; harmful effects on human health, living environment and social life resulted from scienti.c research, development, production and application.” According to the de.nition above, biosafety covers a wide range of content and .elds, including all of the safety problems caused by natural factors and human activities. Therefore, biosafety includes biotechnology, invasion and outbreak of exotics, natural disasters caused by human activities, spread of pandemic diseases and insecurity factors and adverse effects caused by environmental pollution.
3) The narrow conception of biosafety
The biosafety discussed in this book mainly refers to the safety issues related to GM biological engineering technology and products, which is the narrow conception of biosafety. Although the narrow conception has different de.nitions, in g
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