Essentials of Biological Security
A Global Perspective
1. Edition April 2024
320 Pages, Hardcover
Wiley & Sons Ltd
ISBN:
978-1-394-18901-4
John Wiley & Sons
Essentials of Biological Security
A guide to minimizing the threat of misusing benignly intended and dual-use biological research
In Essentials of Biological Security: A Global Perspective, a team of distinguished researchers delivers a fundamental resource designed to raise awareness and understanding of biological security as it pertains to the malign manipulation of benignly intended scientific research.
Written by experts who have spent decades involved in biological security issues, the book is systematically organized to make it accessible to a wide range of life scientists likely to encounter dangerous opportunities for the deliberate misuse of their research. Readers will also find:
* A thorough introduction to biological security and the chemical and biological weapons (CBW) threat spectrum
* Comprehensive explorations of the history of biological weapons from antiquity to modern day
* Practical discussions of dual-use technologies and how to minimize their risk
* Expert analyses of the Biological and Toxin Weapons Convention and other relevant international agreements and organizations
Perfect for professionals working in life sciences, medicine, global health, biosafety, and biosecurity, Essentials of Biological Security: A Global Perspective will also benefit anyone with an interest in and being responsible for biological security.
Endorsement xv
List of Figures xvii
List of Tables xviii
List of Contributors xix
Foreword xxi
Acknowledgements xxv
Acronyms xxvii
1 Biological Security After the Pandemic 1
Lijun Shang, Weiwen Zhang, and Malcolm Dando
1.1 The Objective of the Book 2
1.2 The Structure of the Book 7
1.3 Overview of the Chapters 7
Author Biography 8
References 9
2 Falling Between the Cracks and by the Sides: Can Disarmament Treaties Respond to Scientific and Technological Developments? 11
Jean Pascal Zanders
2.1 Introduction 12
2.2 Concepts of Disease and Toxicants in Relationship to CBW 13
2.2.1 The Impact of Germ Theory on the 'Poison' Concept 14
2.2.2 The Impact of Chemistry on the 'Poison' Concept 15
2.3 Capturing Evolving Concepts of Disease and Toxicants in Restraining Warfare 16
2.4 Further Development of the Control of Toxic Weapons 17
2.4.1 Confirming the Semantic Bifurcation 18
2.4.2 Of Humanitarian Foundations and a Dual-Use Quandary 20
2.5 Implications of Evolving Concepts and S&T Developments for Disarmament Law 21
2.5.1 Institutional Interests 22
2.5.2 Semantic Shifts as Indicators of Scientific and Technological Advancements 22
2.5.3 The Future Dimension of Disarmament 23
2.6 Conclusions: Responding to S&T Developments 25
Author Biography 28
References 28
3 A Multifaceted Threat 31
Gemma Bowsher
3.1 Introduction 32
3.2 Assessing the Utility and Scope of Biological Weapons at Various Scales 33
3.3 Diverse Objectives of Bioweapon Use: Past and Present 34
3.4 Evolving Biotechnologies 36
3.5 Changing Biothreat Landscapes 37
3.5.1 Cyber-Dependency 38
3.5.2 Disinformation 38
3.6 Conclusion 39
Author Biography 40
References 40
4 Biological Weapons from the Ancient World to 1945 43
Brett Edwards
4.1 Introduction 44
4.2 Map of the Literature 45
4.3 Historical Review 46
4.3.1 Pre-history (72,000-500 BCE) 46
4.3.2 Ancient History (500 BCE-1000 AD) 47
4.3.3 Medieval and Early Modern (1000-1750 AD) 48
4.3.4 Late Modern (1750-1915 AD) 49
4.3.5 World War I (1914-1918 AD) 49
4.3.6 Inter-War Years (1918-1939 AD) 50
4.3.7 World War II 51
4.4 Conclusions 52
Author Biography 53
References 53
5 Biological Weapons from 1946 to 2000 57
Brian Balmer
5.1 Introduction 57
5.2 Overview of State BW Programmes 58
5.3 Offensive Aspects of BW Programmes 61
5.3.1 Human Exposure and Experimentation 62
5.4 Non-state Actors 63
5.5 Drivers and Inhibitors of State BW Programmes 65
5.6 Conclusions 66
Author Biography 67
References 67
6 The Problem of Dual Use in the Twenty-first Century 69
Kathryn Nixdorff
6.1 Relationship of the Advances in Science and Technology to the BTWC 70
6.2 Evolution of the Dual-Use Dilemma 71
6.2.1 Example 1. The Mousepox Experiment (2001) 73
6.2.2 Example 2. Synthesis of the Poliovirus Genome and Recovery of Infectious Virus (2002) 74
6.2.3 Example 3. Reconstruction of the 'Spanish Flu' Influenza Virus of 1918 (2005) 74
6.2.4 Example 4. Alteration of the Host Range and Increase in the Transmissibility of the H5N1 Avian Influenza Virus (2012) 75
6.3 DURC Criteria with Examples in Each Case of Published Research Reports of Work That Has DURC Character 75
6.4 Problems in Dealing with Dual Use: Debates About What Should Be Done 78
Author Biography 80
References 80
7 Key Cutting-Edge Biotechnologies Today 83
Xinyu Song and Weiwen Zhang
7.1 Introduction 84
7.2 Development and Application of Synthetic Biology 84
7.2.1 Landmark Achievement in Synthetic Biology 84
7.2.2 Opportunities for Medical Application 85
7.2.3 Benefits to Agricultural Development 85
7.2.4 Changing the Future of Foods 86
7.2.5 Creation of Sustainable Energy 86
7.2.6 Approaches for New Materials 87
7.3 Development and Application of Genome Editing 88
7.3.1 Landmark Progress in Genome Editing 88
7.3.2 Potential in Curing Diseases 88
7.3.3 Supporting Sustainable Agriculture 89
7.4 Main Biosafety and Biosecurity Concerns Associated with Key Cutting-Edge Biotechnologies 90
7.4.1 The Increasing Accessibility of Biotechnology Tools and Techniques Exacerbates Safety and Security Risks 90
7.4.2 Emerging/Re-emerging Infectious Diseases Aggravate the Misuse and Abuse Risk of Cutting-Edge Biotechnologies 90
7.4.3 Integration and Innovation in the Field of Cutting-Edge Technologies Aggravate Safety and Security Risk 91
7.5 Conclusions 91
Author Biography 92
References 92
8 Convergence of Science and Technology 95
Ralf Trapp
8.1 Introduction 96
8.2 Convergence of Science and Technology in the Life Sciences 96
8.3 Convergence and Arms Control and Security 98
8.4 Technologies of Particular Relevance for Possible Misuse of Biology for Nefarious Purposes 100
8.5 Mitigation of the Evolving Misuse Potential Resulting from Convergence 103
Author Biography 105
References 106
9 Role of the Life Science Community in Strengthening the Web of Prevention for Biosafety and Biosecurity 107
Tatyana Novossiolova
9.1 Introduction 108
9.2 Integrating Biosafety with Biosecurity: The Web of Prevention as a Model Concept 109
9.3 Addressing the Threat of Deliberate Biological Events and Life Science Misuse 110
9.3.1 Multi-layered Framework for Response to Deliberate Biological Events 111
9.3.2 An Integrated Approach for Biological Risk Management in Life Science Research and Innovation 114
9.3.3 Biosecurity Risk Communication and Public Engagement 115
9.4 Implications for the Governance of Biotechnology in the Twenty-first Century 117
Author Biography 118
References 118
10 The 1925 Geneva Protocol and the BTWC 121
Jez Littlewood
10.1 Introduction 122
10.2 The Origins and Evolution of the 1925 Geneva Protocol and the BTWC 123
10.3 The Review Conferences of the BTWC and Their Outcomes: 1980-2022 125
10.4 Biological Disarmament as It Is: Strengths and Weakness of the BTWC and the Geneva Protocol in the Twenty-first Century 127
10.5 The BTWC Beyond 50 and the Geneva Protocol Beyond 100: Can They Prevent Biological Warfare? 128
10.6 Conclusion 130
Author Biography 130
References 130
11 Constraining the Weaponisation of Pathogens and Toxic Chemicals Through International Human Rights Law and International Humanitarian Law 133
Michael Crowley
11.1 Introduction 134
11.2 International Humanitarian Law 135
11.2.1 Introduction 135
11.2.2 Over-arching IHL Obligations Constraining Weaponisation of Toxic Chemicals and Pathogens 135
11.2.2.1 The Prohibition of Deliberate Attacks on Civilians, the Prohibition of Indiscriminate Weapons and of Attacks That Do Not Discriminate Between Civilians and Military Objectives 136
11.2.2.2 The Prohibition of the Employment of Means and Methods of Warfare of a Nature to Cause Superfluous Injury or Unnecessary Suffering (SIRUS) 136
11.2.2.3 The Protection of Persons Considered Hors de Combat 137
11.2.2.4 Requirement to Respect and Ensure Respect of International Humanitarian Law 137
11.2.2.5 Prohibition of Methods or Means of Warfare Intended to Cause Widespread, Long-term and Severe Damage to the Natural Environment; Prohibition on the Deliberate Destruction of the Natural Environment as a Form of Weapon 137
11.2.2.6 Obligations to Review 'New' Weapons Under International Humanitarian Law 138
11.3 International Human Rights Law 138
11.3.1 Introduction 138
11.3.2 Protection of the Right to Life and Restrictions on the Use of Force 139
11.3.2.1 Application to Riot Control Agents (RCAs) 140
11.3.2.2 Application to CNS-Acting Chemical Agent Weapons 140
11.3.3 Prohibition Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment 141
11.3.3.1 Application to Psychoactive (CNS)-Acting Chemical Agents 141
11.3.3.2 Application to Riot Control Agents 142
11.3.4 Obligations to Review and Monitor the Use of 'Less Lethal' Weapons 142
11.4 Conclusions 142
Author Biography 144
References 144
12 The Role of International Organisations in Biosecurity and the Prevention of Biological Warfare 147
Louison Mazeaud, James Revill, Jaroslav Krasny, and Vivienne Zhang
12.1 Introduction 148
12.2 The Role of IOs in Fostering the Norm Against Biological Weapons 149
12.3 IOs in the Genesis of the Biological and Toxin Weapons Convention 150
12.3.1 Conference of the Eighteen-Nation Committee on Disarmament 150
12.3.2 The UN Secretary-General's CBW Report 150
12.3.3 The WHO Report on Health Aspects of CBW 151
12.4 IOs and the Evolution of Biosecurity Governance 151
12.4.1 UNSC Resolution 1540 151
12.4.2 UN Secretary General's Mechanism (Authoritative and Objective Assessment) 152
12.4.3 Tending the BWC: The Implementation Support Unit (ISU) and the Work of Unoda 153
12.4.4 WHO, Biosecurity and the Governance of Dual-Use Research 153
12.4.5 Combatting Biological Crimes: United Nations Interregional Crime and Justice Research Institute (UNICRI) 153
12.4.6 Unidir 154
12.5 The Strengths of IOs in Biosecurity and Prevention of Biological Warfare 155
12.6 The Limits of IOs in Biosecurity and Prevention of Biological Warfare 155
12.7 Conclusions 156
Author Biography 156
References 157
13 Laboratory Biorisk Management as a Key Tool for Scientists to Understand Future Biological Threats and Strengthen the Biological Weapons Convention 161
Mayra Ameneiros
13.1 History, Context and Current International Guidance 162
13.2 Biosafety and Biosecurity Awareness 165
13.3 The Role of Scientists: Tailored Biorisk Management Practices 167
13.4 Case Scenarios: Practical Examples 168
13.5 An Ongoing Cycle to Strengthen the Biological Weapons Convention 170
Author Biography 170
References 170
14 Examples of Biorisk Management National Regulatory Frameworks 173
Dana Perkins and Lela Bakanidze
14.1 Introduction 174
14.2 Laboratory Biosafety and Biosecurity in the US 175
14.3 Import-Export and Transportation of Infectious Substances in the US 179
14.4 Genetic Engineering and Dual-Use Oversight in the US 180
14.5 The Culture of Biosafety, Biosecurity and Responsible Conduct in the US 181
14.6 The Biorisk Management National Regulatory Framework of Georgia 182
14.7 Conclusion 185
Author Biography 186
References 186
15 Lessons from ePPP Research and the COVID-19 Pandemic 189
Nariyoshi Shinomiya
15.1 Advances in Life Science and Technology and the Emergence of 'So-Called GOF Studies' to Create ePPPs 190
15.2 Controversy Surrounding GOF Studies on H5N1 Highly Pathogenic Avian Influenza Virus 192
15.3 COVID-19 and GOF Studies on SARS-like Viruses 195
15.4 Ongoing Discussions at the NSABB and Governance by HHS 196
15.5 Future Governance of GOF Research and Prospects 198
Author Biography 199
References 199
16 The Hague Ethical Guidelines and the Tianjin Biosecurity Guidelines 201
Yang Xue
16.1 Relations Between the Hague Ethical Guidelines and the Tianjin Biosecurity Guidelines 202
16.1.1 Commonality in International Soft Law 202
16.1.2 Commonality in Global Public Goods 203
16.1.3 Effective Multilateralism 203
16.2 BTWC Advances the Formulation of the Tianjin Biosecurity Guidelines for Responsible Scientific Research 204
16.2.1 Institutional Basis of BTWC for Responsible Scientific Research 204
16.2.2 BTWC Advances the Development of the Code of Conduct for Responsible Scientific Research 205
16.3 Constitution of the Tianjin Biosecurity Guidelines: Ideas, Principles, Elements and Path Formation 207
16.3.1 Ideas 207
16.3.2 Principles 208
16.3.3 Path Formation 209
16.4 Future Discussion 210
Author Biography 211
References 211
17 Engaging Scientists in Biorisk Management 213
Yuhan Bao and Alonso Flores
17.1 Introduction: Scientists Engagement and Biorisk Management 214
17.2 Engaging Scientists in Biorisk Management at International Level: Case from IWG Assessment Framework 215
17.2.1 Building the Culture of Responsibility: The Key Elements and Approaches of Engaging Scientist in Biorisk Management 215
17.2.2 Improving the Culture of Responsibility: Engaging Scientist in the Assessment of Biorisk Management Systems 218
17.3 Engaging Scientists in Biorisk Management in National Institutional Oversight: Case from the Netherlands 219
17.4 Engaging Scientists in Biorisk Management in Community: Case from iGEM 220
17.4.1 Engaging Scientists Through iGEM Safety Rules Checklist and Safety Screening System 221
17.4.2 Engaging Scientists Through iGEM Human Practices Programme 222
17.5 Conclusion: How to Engage Scientists in Management of Biorisk and Other Emerging Fields 223
Author Biography 223
References 224
18 The Role of Ethics in Dealing with Dual Use 225
Leifan Wang
18.1 The Dual-Use Concept and Concerns 226
18.2 Ethics as an Instrument on Dual-Use Governance 227
18.2.1 Ethics Promote Responsible Practices on Dual Use 227
18.2.2 Limitation of Ethics in Dealing with Dual Use 229
18.3 Existing and Complementary Ethical Guidelines on Dual Use 230
18.4 Recent Dual-Use Scenarios 231
18.4.1 Synthetic Biology 231
18.4.2 Gene Editing 232
18.4.3 Neuroscience 232
18.4.4 Digital Biological Data 233
18.5 Ethical Education for Future Dual Use 233
Author Biography 234
References 234
19 Where Is the Governance of Dual-Use Science Going? 237
Nancy Connell and Gigi Gronvall
19.1 Background: Genetic Technologies and Their Applications 238
19.2 Dual-Use Science: Evolving Story of a Dualistic Term 239
19.3 Begin with the Experts: Models of Self-regulation 240
19.3.1 From Asilomar to Napa 240
19.3.2 Tools for Self-regulation: Risk and Benefit Analyses: Useful Frameworks 241
19.3.3 A Patchwork of Layered Oversight, from Global to Local 241
19.3.4 Self-regulation: The Basis of Scientific Enterprise 243
19.3.5 Oversight Along the Life Cycle of Research: Universities Are Sites of Layered Governance 243
19.3.6 Toward an International Model: International Collaboration in Science and Technology (ICST) 244
19.3.7 International Standards for Biosafety and Biosecurity 245
19.4 Alternative Governance Structures 245
19.4.1 Hybrid Governance Models 245
19.4.2 Network-Based Governance 246
19.4.3 Transnational Governance 246
19.5 Conclusion 247
Author Biography 247
References 248
20 Towards an International Biosecurity Education Network (IBSEN) 251
Kathryn Millett and Lijun Shang
20.1 Introduction 252
20.2 The Need for Biosecurity Education, Awareness-Raising and a Culture of Responsibility in the Life Sciences 252
20.3 Past Efforts in Educating Life Scientists and Establishing a Culture of Responsibility 253
20.4 Challenges Faced by Biosecurity Education and Awareness-Raising 258
20.5 Comparable Approaches Implemented in Analogous Frameworks in the Nuclear and Chemistry Fields 259
20.5.1 IAEA Nuclear Security Culture and the International Nuclear Security Education Network (INSEN) 260
20.5.2 Chemical Weapons Convention and the Advisory Board on Education and Outreach (ABEO) 262
20.5.3 Key Lessons from the INSEN and ABEO for an International Biosecurity Educational Network (IBSEN) 264
20.5.3.1 Comprehensive Understanding Learned from Related Initiatives 264
20.5.3.2 A Biosecurity Education Network Must Be Underpinned by Firm and Sustained Commitment from States and the Future Network's Host Body (Such as the Biological and Toxin Weapons Convention) 264
20.5.3.3 Sustained Financial Support Observed and Maintained 264
20.5.3.4 Strategic Vision and Clear Pathways Are Required for Communication and Collaboration Between a Network and Treaty Bodies/States 265
20.5.3.5 Diversity of Memberships and Engagement with a Wide Range of Stakeholders 265
20.6 Conclusion 266
Author Biography 267
References 268
Appendix A: The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists 269
Index 273
List of Figures xvii
List of Tables xviii
List of Contributors xix
Foreword xxi
Acknowledgements xxv
Acronyms xxvii
1 Biological Security After the Pandemic 1
Lijun Shang, Weiwen Zhang, and Malcolm Dando
1.1 The Objective of the Book 2
1.2 The Structure of the Book 7
1.3 Overview of the Chapters 7
Author Biography 8
References 9
2 Falling Between the Cracks and by the Sides: Can Disarmament Treaties Respond to Scientific and Technological Developments? 11
Jean Pascal Zanders
2.1 Introduction 12
2.2 Concepts of Disease and Toxicants in Relationship to CBW 13
2.2.1 The Impact of Germ Theory on the 'Poison' Concept 14
2.2.2 The Impact of Chemistry on the 'Poison' Concept 15
2.3 Capturing Evolving Concepts of Disease and Toxicants in Restraining Warfare 16
2.4 Further Development of the Control of Toxic Weapons 17
2.4.1 Confirming the Semantic Bifurcation 18
2.4.2 Of Humanitarian Foundations and a Dual-Use Quandary 20
2.5 Implications of Evolving Concepts and S&T Developments for Disarmament Law 21
2.5.1 Institutional Interests 22
2.5.2 Semantic Shifts as Indicators of Scientific and Technological Advancements 22
2.5.3 The Future Dimension of Disarmament 23
2.6 Conclusions: Responding to S&T Developments 25
Author Biography 28
References 28
3 A Multifaceted Threat 31
Gemma Bowsher
3.1 Introduction 32
3.2 Assessing the Utility and Scope of Biological Weapons at Various Scales 33
3.3 Diverse Objectives of Bioweapon Use: Past and Present 34
3.4 Evolving Biotechnologies 36
3.5 Changing Biothreat Landscapes 37
3.5.1 Cyber-Dependency 38
3.5.2 Disinformation 38
3.6 Conclusion 39
Author Biography 40
References 40
4 Biological Weapons from the Ancient World to 1945 43
Brett Edwards
4.1 Introduction 44
4.2 Map of the Literature 45
4.3 Historical Review 46
4.3.1 Pre-history (72,000-500 BCE) 46
4.3.2 Ancient History (500 BCE-1000 AD) 47
4.3.3 Medieval and Early Modern (1000-1750 AD) 48
4.3.4 Late Modern (1750-1915 AD) 49
4.3.5 World War I (1914-1918 AD) 49
4.3.6 Inter-War Years (1918-1939 AD) 50
4.3.7 World War II 51
4.4 Conclusions 52
Author Biography 53
References 53
5 Biological Weapons from 1946 to 2000 57
Brian Balmer
5.1 Introduction 57
5.2 Overview of State BW Programmes 58
5.3 Offensive Aspects of BW Programmes 61
5.3.1 Human Exposure and Experimentation 62
5.4 Non-state Actors 63
5.5 Drivers and Inhibitors of State BW Programmes 65
5.6 Conclusions 66
Author Biography 67
References 67
6 The Problem of Dual Use in the Twenty-first Century 69
Kathryn Nixdorff
6.1 Relationship of the Advances in Science and Technology to the BTWC 70
6.2 Evolution of the Dual-Use Dilemma 71
6.2.1 Example 1. The Mousepox Experiment (2001) 73
6.2.2 Example 2. Synthesis of the Poliovirus Genome and Recovery of Infectious Virus (2002) 74
6.2.3 Example 3. Reconstruction of the 'Spanish Flu' Influenza Virus of 1918 (2005) 74
6.2.4 Example 4. Alteration of the Host Range and Increase in the Transmissibility of the H5N1 Avian Influenza Virus (2012) 75
6.3 DURC Criteria with Examples in Each Case of Published Research Reports of Work That Has DURC Character 75
6.4 Problems in Dealing with Dual Use: Debates About What Should Be Done 78
Author Biography 80
References 80
7 Key Cutting-Edge Biotechnologies Today 83
Xinyu Song and Weiwen Zhang
7.1 Introduction 84
7.2 Development and Application of Synthetic Biology 84
7.2.1 Landmark Achievement in Synthetic Biology 84
7.2.2 Opportunities for Medical Application 85
7.2.3 Benefits to Agricultural Development 85
7.2.4 Changing the Future of Foods 86
7.2.5 Creation of Sustainable Energy 86
7.2.6 Approaches for New Materials 87
7.3 Development and Application of Genome Editing 88
7.3.1 Landmark Progress in Genome Editing 88
7.3.2 Potential in Curing Diseases 88
7.3.3 Supporting Sustainable Agriculture 89
7.4 Main Biosafety and Biosecurity Concerns Associated with Key Cutting-Edge Biotechnologies 90
7.4.1 The Increasing Accessibility of Biotechnology Tools and Techniques Exacerbates Safety and Security Risks 90
7.4.2 Emerging/Re-emerging Infectious Diseases Aggravate the Misuse and Abuse Risk of Cutting-Edge Biotechnologies 90
7.4.3 Integration and Innovation in the Field of Cutting-Edge Technologies Aggravate Safety and Security Risk 91
7.5 Conclusions 91
Author Biography 92
References 92
8 Convergence of Science and Technology 95
Ralf Trapp
8.1 Introduction 96
8.2 Convergence of Science and Technology in the Life Sciences 96
8.3 Convergence and Arms Control and Security 98
8.4 Technologies of Particular Relevance for Possible Misuse of Biology for Nefarious Purposes 100
8.5 Mitigation of the Evolving Misuse Potential Resulting from Convergence 103
Author Biography 105
References 106
9 Role of the Life Science Community in Strengthening the Web of Prevention for Biosafety and Biosecurity 107
Tatyana Novossiolova
9.1 Introduction 108
9.2 Integrating Biosafety with Biosecurity: The Web of Prevention as a Model Concept 109
9.3 Addressing the Threat of Deliberate Biological Events and Life Science Misuse 110
9.3.1 Multi-layered Framework for Response to Deliberate Biological Events 111
9.3.2 An Integrated Approach for Biological Risk Management in Life Science Research and Innovation 114
9.3.3 Biosecurity Risk Communication and Public Engagement 115
9.4 Implications for the Governance of Biotechnology in the Twenty-first Century 117
Author Biography 118
References 118
10 The 1925 Geneva Protocol and the BTWC 121
Jez Littlewood
10.1 Introduction 122
10.2 The Origins and Evolution of the 1925 Geneva Protocol and the BTWC 123
10.3 The Review Conferences of the BTWC and Their Outcomes: 1980-2022 125
10.4 Biological Disarmament as It Is: Strengths and Weakness of the BTWC and the Geneva Protocol in the Twenty-first Century 127
10.5 The BTWC Beyond 50 and the Geneva Protocol Beyond 100: Can They Prevent Biological Warfare? 128
10.6 Conclusion 130
Author Biography 130
References 130
11 Constraining the Weaponisation of Pathogens and Toxic Chemicals Through International Human Rights Law and International Humanitarian Law 133
Michael Crowley
11.1 Introduction 134
11.2 International Humanitarian Law 135
11.2.1 Introduction 135
11.2.2 Over-arching IHL Obligations Constraining Weaponisation of Toxic Chemicals and Pathogens 135
11.2.2.1 The Prohibition of Deliberate Attacks on Civilians, the Prohibition of Indiscriminate Weapons and of Attacks That Do Not Discriminate Between Civilians and Military Objectives 136
11.2.2.2 The Prohibition of the Employment of Means and Methods of Warfare of a Nature to Cause Superfluous Injury or Unnecessary Suffering (SIRUS) 136
11.2.2.3 The Protection of Persons Considered Hors de Combat 137
11.2.2.4 Requirement to Respect and Ensure Respect of International Humanitarian Law 137
11.2.2.5 Prohibition of Methods or Means of Warfare Intended to Cause Widespread, Long-term and Severe Damage to the Natural Environment; Prohibition on the Deliberate Destruction of the Natural Environment as a Form of Weapon 137
11.2.2.6 Obligations to Review 'New' Weapons Under International Humanitarian Law 138
11.3 International Human Rights Law 138
11.3.1 Introduction 138
11.3.2 Protection of the Right to Life and Restrictions on the Use of Force 139
11.3.2.1 Application to Riot Control Agents (RCAs) 140
11.3.2.2 Application to CNS-Acting Chemical Agent Weapons 140
11.3.3 Prohibition Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment 141
11.3.3.1 Application to Psychoactive (CNS)-Acting Chemical Agents 141
11.3.3.2 Application to Riot Control Agents 142
11.3.4 Obligations to Review and Monitor the Use of 'Less Lethal' Weapons 142
11.4 Conclusions 142
Author Biography 144
References 144
12 The Role of International Organisations in Biosecurity and the Prevention of Biological Warfare 147
Louison Mazeaud, James Revill, Jaroslav Krasny, and Vivienne Zhang
12.1 Introduction 148
12.2 The Role of IOs in Fostering the Norm Against Biological Weapons 149
12.3 IOs in the Genesis of the Biological and Toxin Weapons Convention 150
12.3.1 Conference of the Eighteen-Nation Committee on Disarmament 150
12.3.2 The UN Secretary-General's CBW Report 150
12.3.3 The WHO Report on Health Aspects of CBW 151
12.4 IOs and the Evolution of Biosecurity Governance 151
12.4.1 UNSC Resolution 1540 151
12.4.2 UN Secretary General's Mechanism (Authoritative and Objective Assessment) 152
12.4.3 Tending the BWC: The Implementation Support Unit (ISU) and the Work of Unoda 153
12.4.4 WHO, Biosecurity and the Governance of Dual-Use Research 153
12.4.5 Combatting Biological Crimes: United Nations Interregional Crime and Justice Research Institute (UNICRI) 153
12.4.6 Unidir 154
12.5 The Strengths of IOs in Biosecurity and Prevention of Biological Warfare 155
12.6 The Limits of IOs in Biosecurity and Prevention of Biological Warfare 155
12.7 Conclusions 156
Author Biography 156
References 157
13 Laboratory Biorisk Management as a Key Tool for Scientists to Understand Future Biological Threats and Strengthen the Biological Weapons Convention 161
Mayra Ameneiros
13.1 History, Context and Current International Guidance 162
13.2 Biosafety and Biosecurity Awareness 165
13.3 The Role of Scientists: Tailored Biorisk Management Practices 167
13.4 Case Scenarios: Practical Examples 168
13.5 An Ongoing Cycle to Strengthen the Biological Weapons Convention 170
Author Biography 170
References 170
14 Examples of Biorisk Management National Regulatory Frameworks 173
Dana Perkins and Lela Bakanidze
14.1 Introduction 174
14.2 Laboratory Biosafety and Biosecurity in the US 175
14.3 Import-Export and Transportation of Infectious Substances in the US 179
14.4 Genetic Engineering and Dual-Use Oversight in the US 180
14.5 The Culture of Biosafety, Biosecurity and Responsible Conduct in the US 181
14.6 The Biorisk Management National Regulatory Framework of Georgia 182
14.7 Conclusion 185
Author Biography 186
References 186
15 Lessons from ePPP Research and the COVID-19 Pandemic 189
Nariyoshi Shinomiya
15.1 Advances in Life Science and Technology and the Emergence of 'So-Called GOF Studies' to Create ePPPs 190
15.2 Controversy Surrounding GOF Studies on H5N1 Highly Pathogenic Avian Influenza Virus 192
15.3 COVID-19 and GOF Studies on SARS-like Viruses 195
15.4 Ongoing Discussions at the NSABB and Governance by HHS 196
15.5 Future Governance of GOF Research and Prospects 198
Author Biography 199
References 199
16 The Hague Ethical Guidelines and the Tianjin Biosecurity Guidelines 201
Yang Xue
16.1 Relations Between the Hague Ethical Guidelines and the Tianjin Biosecurity Guidelines 202
16.1.1 Commonality in International Soft Law 202
16.1.2 Commonality in Global Public Goods 203
16.1.3 Effective Multilateralism 203
16.2 BTWC Advances the Formulation of the Tianjin Biosecurity Guidelines for Responsible Scientific Research 204
16.2.1 Institutional Basis of BTWC for Responsible Scientific Research 204
16.2.2 BTWC Advances the Development of the Code of Conduct for Responsible Scientific Research 205
16.3 Constitution of the Tianjin Biosecurity Guidelines: Ideas, Principles, Elements and Path Formation 207
16.3.1 Ideas 207
16.3.2 Principles 208
16.3.3 Path Formation 209
16.4 Future Discussion 210
Author Biography 211
References 211
17 Engaging Scientists in Biorisk Management 213
Yuhan Bao and Alonso Flores
17.1 Introduction: Scientists Engagement and Biorisk Management 214
17.2 Engaging Scientists in Biorisk Management at International Level: Case from IWG Assessment Framework 215
17.2.1 Building the Culture of Responsibility: The Key Elements and Approaches of Engaging Scientist in Biorisk Management 215
17.2.2 Improving the Culture of Responsibility: Engaging Scientist in the Assessment of Biorisk Management Systems 218
17.3 Engaging Scientists in Biorisk Management in National Institutional Oversight: Case from the Netherlands 219
17.4 Engaging Scientists in Biorisk Management in Community: Case from iGEM 220
17.4.1 Engaging Scientists Through iGEM Safety Rules Checklist and Safety Screening System 221
17.4.2 Engaging Scientists Through iGEM Human Practices Programme 222
17.5 Conclusion: How to Engage Scientists in Management of Biorisk and Other Emerging Fields 223
Author Biography 223
References 224
18 The Role of Ethics in Dealing with Dual Use 225
Leifan Wang
18.1 The Dual-Use Concept and Concerns 226
18.2 Ethics as an Instrument on Dual-Use Governance 227
18.2.1 Ethics Promote Responsible Practices on Dual Use 227
18.2.2 Limitation of Ethics in Dealing with Dual Use 229
18.3 Existing and Complementary Ethical Guidelines on Dual Use 230
18.4 Recent Dual-Use Scenarios 231
18.4.1 Synthetic Biology 231
18.4.2 Gene Editing 232
18.4.3 Neuroscience 232
18.4.4 Digital Biological Data 233
18.5 Ethical Education for Future Dual Use 233
Author Biography 234
References 234
19 Where Is the Governance of Dual-Use Science Going? 237
Nancy Connell and Gigi Gronvall
19.1 Background: Genetic Technologies and Their Applications 238
19.2 Dual-Use Science: Evolving Story of a Dualistic Term 239
19.3 Begin with the Experts: Models of Self-regulation 240
19.3.1 From Asilomar to Napa 240
19.3.2 Tools for Self-regulation: Risk and Benefit Analyses: Useful Frameworks 241
19.3.3 A Patchwork of Layered Oversight, from Global to Local 241
19.3.4 Self-regulation: The Basis of Scientific Enterprise 243
19.3.5 Oversight Along the Life Cycle of Research: Universities Are Sites of Layered Governance 243
19.3.6 Toward an International Model: International Collaboration in Science and Technology (ICST) 244
19.3.7 International Standards for Biosafety and Biosecurity 245
19.4 Alternative Governance Structures 245
19.4.1 Hybrid Governance Models 245
19.4.2 Network-Based Governance 246
19.4.3 Transnational Governance 246
19.5 Conclusion 247
Author Biography 247
References 248
20 Towards an International Biosecurity Education Network (IBSEN) 251
Kathryn Millett and Lijun Shang
20.1 Introduction 252
20.2 The Need for Biosecurity Education, Awareness-Raising and a Culture of Responsibility in the Life Sciences 252
20.3 Past Efforts in Educating Life Scientists and Establishing a Culture of Responsibility 253
20.4 Challenges Faced by Biosecurity Education and Awareness-Raising 258
20.5 Comparable Approaches Implemented in Analogous Frameworks in the Nuclear and Chemistry Fields 259
20.5.1 IAEA Nuclear Security Culture and the International Nuclear Security Education Network (INSEN) 260
20.5.2 Chemical Weapons Convention and the Advisory Board on Education and Outreach (ABEO) 262
20.5.3 Key Lessons from the INSEN and ABEO for an International Biosecurity Educational Network (IBSEN) 264
20.5.3.1 Comprehensive Understanding Learned from Related Initiatives 264
20.5.3.2 A Biosecurity Education Network Must Be Underpinned by Firm and Sustained Commitment from States and the Future Network's Host Body (Such as the Biological and Toxin Weapons Convention) 264
20.5.3.3 Sustained Financial Support Observed and Maintained 264
20.5.3.4 Strategic Vision and Clear Pathways Are Required for Communication and Collaboration Between a Network and Treaty Bodies/States 265
20.5.3.5 Diversity of Memberships and Engagement with a Wide Range of Stakeholders 265
20.6 Conclusion 266
Author Biography 267
References 268
Appendix A: The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists 269
Index 273
Lijun Shang, PhD, is Professor of Biomedical Sciences in the School of Human Sciences at London Metropolitan University, UK. He is the founding Director of the Biological Security Research Centre. His research focuses primarily on ion channels in the fields of health and disease.
Weiwen Zhang, PhD, is Baiyang Chair Professor of Microbiology and Biochemical Engineering at Tianjin University of China, China. His recent research is focused on synthetic biology and governance of dual-use issues, and he currently serves as Chief Scientist of the National Key Research and Development Program of Synthetic Biology in China.
Malcolm Dando, PhD, is a Fellow of the UK Royal Society of Biology. He is Emeritus Professor at the University of Bradford, UK and is the author of Neuroscience and the Problem of Dual Use: Neuroethics in New Brain Projects.
Weiwen Zhang, PhD, is Baiyang Chair Professor of Microbiology and Biochemical Engineering at Tianjin University of China, China. His recent research is focused on synthetic biology and governance of dual-use issues, and he currently serves as Chief Scientist of the National Key Research and Development Program of Synthetic Biology in China.
Malcolm Dando, PhD, is a Fellow of the UK Royal Society of Biology. He is Emeritus Professor at the University of Bradford, UK and is the author of Neuroscience and the Problem of Dual Use: Neuroethics in New Brain Projects.
