Essentials of Biological Security

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.

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