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.

Table of Contents:
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