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 xvList of Figures xviiList of Tables xviiiList of Contributors xixForeword xxiAcknowledgements xxvAcronyms xxvii1 Biological Security After the Pandemic 1Lijun Shang, Weiwen Zhang, and Malcolm Dando1.1 The Objective of the Book 21.2 The Structure of the Book 71.3 Overview of the Chapters 7Author Biography 8References 92 Falling Between the Cracks and by the Sides: Can Disarmament Treaties Respond to Scientific and Technological Developments? 11Jean Pascal Zanders2.1 Introduction 122.2 Concepts of Disease and Toxicants in Relationship to CBW 132.2.1 The Impact of Germ Theory on the ‘Poison’ Concept 142.2.2 The Impact of Chemistry on the ‘Poison’ Concept 152.3 Capturing Evolving Concepts of Disease and Toxicants in Restraining Warfare 162.4 Further Development of the Control of Toxic Weapons 172.4.1 Confirming the Semantic Bifurcation 182.4.2 Of Humanitarian Foundations and a Dual-Use Quandary 202.5 Implications of Evolving Concepts and S&T Developments for Disarmament Law 212.5.1 Institutional Interests 222.5.2 Semantic Shifts as Indicators of Scientific and Technological Advancements 222.5.3 The Future Dimension of Disarmament 232.6 Conclusions: Responding to S&T Developments 25Author Biography 28References 283 A Multifaceted Threat 31Gemma Bowsher3.1 Introduction 323.2 Assessing the Utility and Scope of Biological Weapons at Various Scales 333.3 Diverse Objectives of Bioweapon Use: Past and Present 343.4 Evolving Biotechnologies 363.5 Changing Biothreat Landscapes 373.5.1 Cyber-Dependency 383.5.2 Disinformation 383.6 Conclusion 39Author Biography 40References 404 Biological Weapons from the Ancient World to 1945 43Brett Edwards4.1 Introduction 444.2 Map of the Literature 454.3 Historical Review 464.3.1 Pre-history (72,000–500 BCE) 464.3.2 Ancient History (500 BCE–1000 AD) 474.3.3 Medieval and Early Modern (1000–1750 AD) 484.3.4 Late Modern (1750–1915 AD) 494.3.5 World War I (1914–1918 AD) 494.3.6 Inter-War Years (1918–1939 AD) 504.3.7 World War II 514.4 Conclusions 52Author Biography 53References 535 Biological Weapons from 1946 to 2000 57Brian Balmer5.1 Introduction 575.2 Overview of State BW Programmes 585.3 Offensive Aspects of BW Programmes 615.3.1 Human Exposure and Experimentation 625.4 Non-state Actors 635.5 Drivers and Inhibitors of State BW Programmes 655.6 Conclusions 66Author Biography 67References 676 The Problem of Dual Use in the Twenty-first Century 69Kathryn Nixdorff6.1 Relationship of the Advances in Science and Technology to the BTWC 706.2 Evolution of the Dual-Use Dilemma 716.2.1 Example 1. The Mousepox Experiment (2001) 736.2.2 Example 2. Synthesis of the Poliovirus Genome and Recovery of Infectious Virus (2002) 746.2.3 Example 3. Reconstruction of the ‘Spanish Flu’ Influenza Virus of 1918 (2005) 746.2.4 Example 4. Alteration of the Host Range and Increase in the Transmissibility of the H5N1 Avian Influenza Virus (2012) 756.3 DURC Criteria with Examples in Each Case of Published Research Reports of Work That Has DURC Character 756.4 Problems in Dealing with Dual Use: Debates About What Should Be Done 78Author Biography 80References 807 Key Cutting-Edge Biotechnologies Today 83Xinyu Song and Weiwen Zhang7.1 Introduction 847.2 Development and Application of Synthetic Biology 847.2.1 Landmark Achievement in Synthetic Biology 847.2.2 Opportunities for Medical Application 857.2.3 Benefits to Agricultural Development 857.2.4 Changing the Future of Foods 867.2.5 Creation of Sustainable Energy 867.2.6 Approaches for New Materials 877.3 Development and Application of Genome Editing 887.3.1 Landmark Progress in Genome Editing 887.3.2 Potential in Curing Diseases 887.3.3 Supporting Sustainable Agriculture 897.4 Main Biosafety and Biosecurity Concerns Associated with Key Cutting-Edge Biotechnologies 907.4.1 The Increasing Accessibility of Biotechnology Tools and Techniques Exacerbates Safety and Security Risks 907.4.2 Emerging/Re-emerging Infectious Diseases Aggravate the Misuse and Abuse Risk of Cutting-Edge Biotechnologies 907.4.3 Integration and Innovation in the Field of Cutting-Edge Technologies Aggravate Safety and Security Risk 917.5 Conclusions 91Author Biography 92References 928 Convergence of Science and Technology 95Ralf Trapp8.1 Introduction 968.2 Convergence of Science and Technology in the Life Sciences 968.3 Convergence and Arms Control and Security 988.4 Technologies of Particular Relevance for Possible Misuse of Biology for Nefarious Purposes 1008.5 Mitigation of the Evolving Misuse Potential Resulting from Convergence 103Author Biography 105References 1069 Role of the Life Science Community in Strengthening the Web of Prevention for Biosafety and Biosecurity 107Tatyana Novossiolova9.1 Introduction 1089.2 Integrating Biosafety with Biosecurity: The Web of Prevention as a Model Concept 1099.3 Addressing the Threat of Deliberate Biological Events and Life Science Misuse 1109.3.1 Multi-layered Framework for Response to Deliberate Biological Events 1119.3.2 An Integrated Approach for Biological Risk Management in Life Science Research and Innovation 1149.3.3 Biosecurity Risk Communication and Public Engagement 1159.4 Implications for the Governance of Biotechnology in the Twenty-first Century 117Author Biography 118References 11810 The 1925 Geneva Protocol and the BTWC 121Jez Littlewood10.1 Introduction 12210.2 The Origins and Evolution of the 1925 Geneva Protocol and the BTWC 12310.3 The Review Conferences of the BTWC and Their Outcomes: 1980–2022 12510.4 Biological Disarmament as It Is: Strengths and Weakness of the BTWC and the Geneva Protocol in the Twenty-first Century 12710.5 The BTWC Beyond 50 and the Geneva Protocol Beyond 100: Can They Prevent Biological Warfare? 12810.6 Conclusion 130Author Biography 130References 13011 Constraining the Weaponisation of Pathogens and Toxic Chemicals Through International Human Rights Law and International Humanitarian Law 133Michael Crowley11.1 Introduction 13411.2 International Humanitarian Law 13511.2.1 Introduction 13511.2.2 Over-arching IHL Obligations Constraining Weaponisation of Toxic Chemicals and Pathogens 13511.2.2.1 The Prohibition of Deliberate Attacks on Civilians, the Prohibition of Indiscriminate Weapons and of Attacks That Do Not Discriminate Between Civilians and Military Objectives 13611.2.2.2 The Prohibition of the Employment of Means and Methods of Warfare of a Nature to Cause Superfluous Injury or Unnecessary Suffering (SIRUS) 13611.2.2.3 The Protection of Persons Considered Hors de Combat 13711.2.2.4 Requirement to Respect and Ensure Respect of International Humanitarian Law 13711.2.2.5 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 13711.2.2.6 Obligations to Review ‘New’ Weapons Under International Humanitarian Law 13811.3 International Human Rights Law 13811.3.1 Introduction 13811.3.2 Protection of the Right to Life and Restrictions on the Use of Force 13911.3.2.1 Application to Riot Control Agents (RCAs) 14011.3.2.2 Application to CNS-Acting Chemical Agent Weapons 14011.3.3 Prohibition Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment 14111.3.3.1 Application to Psychoactive (CNS)-Acting Chemical Agents 14111.3.3.2 Application to Riot Control Agents 14211.3.4 Obligations to Review and Monitor the Use of ‘Less Lethal’ Weapons 14211.4 Conclusions 142Author Biography 144References 14412 The Role of International Organisations in Biosecurity and the Prevention of Biological Warfare 147Louison Mazeaud, James Revill, Jaroslav Krasny, and Vivienne Zhang12.1 Introduction 14812.2 The Role of IOs in Fostering the Norm Against Biological Weapons 14912.3 IOs in the Genesis of the Biological and Toxin Weapons Convention 15012.3.1 Conference of the Eighteen-Nation Committee on Disarmament 15012.3.2 The UN Secretary-General’s CBW Report 15012.3.3 The WHO Report on Health Aspects of CBW 15112.4 IOs and the Evolution of Biosecurity Governance 15112.4.1 UNSC Resolution 1540 15112.4.2 UN Secretary General’s Mechanism (Authoritative and Objective Assessment) 15212.4.3 Tending the BWC: The Implementation Support Unit (ISU) and the Work of Unoda 15312.4.4 WHO, Biosecurity and the Governance of Dual-Use Research 15312.4.5 Combatting Biological Crimes: United Nations Interregional Crime and Justice Research Institute (UNICRI) 15312.4.6 Unidir 15412.5 The Strengths of IOs in Biosecurity and Prevention of Biological Warfare 15512.6 The Limits of IOs in Biosecurity and Prevention of Biological Warfare 15512.7 Conclusions 156Author Biography 156References 15713 Laboratory Biorisk Management as a Key Tool for Scientists to Understand Future Biological Threats and Strengthen the Biological Weapons Convention 161Mayra Ameneiros13.1 History, Context and Current International Guidance 16213.2 Biosafety and Biosecurity Awareness 16513.3 The Role of Scientists: Tailored Biorisk Management Practices 16713.4 Case Scenarios: Practical Examples 16813.5 An Ongoing Cycle to Strengthen the Biological Weapons Convention 170Author Biography 170References 17014 Examples of Biorisk Management National Regulatory Frameworks 173Dana Perkins and Lela Bakanidze14.1 Introduction 17414.2 Laboratory Biosafety and Biosecurity in the US 17514.3 Import–Export and Transportation of Infectious Substances in the US 17914.4 Genetic Engineering and Dual-Use Oversight in the US 18014.5 The Culture of Biosafety, Biosecurity and Responsible Conduct in the US 18114.6 The Biorisk Management National Regulatory Framework of Georgia 18214.7 Conclusion 185Author Biography 186References 18615 Lessons from ePPP Research and the COVID-19 Pandemic 189Nariyoshi Shinomiya15.1 Advances in Life Science and Technology and the Emergence of ‘So-Called GOF Studies’ to Create ePPPs 19015.2 Controversy Surrounding GOF Studies on H5N1 Highly Pathogenic Avian Influenza Virus 19215.3 COVID-19 and GOF Studies on SARS-like Viruses 19515.4 Ongoing Discussions at the NSABB and Governance by HHS 19615.5 Future Governance of GOF Research and Prospects 198Author Biography 199References 19916 The Hague Ethical Guidelines and the Tianjin Biosecurity Guidelines 201Yang Xue16.1 Relations Between the Hague Ethical Guidelines and the Tianjin Biosecurity Guidelines 20216.1.1 Commonality in International Soft Law 20216.1.2 Commonality in Global Public Goods 20316.1.3 Effective Multilateralism 20316.2 BTWC Advances the Formulation of the Tianjin Biosecurity Guidelines for Responsible Scientific Research 20416.2.1 Institutional Basis of BTWC for Responsible Scientific Research 20416.2.2 BTWC Advances the Development of the Code of Conduct for Responsible Scientific Research 20516.3 Constitution of the Tianjin Biosecurity Guidelines: Ideas, Principles, Elements and Path Formation 20716.3.1 Ideas 20716.3.2 Principles 20816.3.3 Path Formation 20916.4 Future Discussion 210Author Biography 211References 21117 Engaging Scientists in Biorisk Management 213Yuhan Bao and Alonso Flores17.1 Introduction: Scientists Engagement and Biorisk Management 21417.2 Engaging Scientists in Biorisk Management at International Level: Case from IWG Assessment Framework 21517.2.1 Building the Culture of Responsibility: The Key Elements and Approaches of Engaging Scientist in Biorisk Management 21517.2.2 Improving the Culture of Responsibility: Engaging Scientist in the Assessment of Biorisk Management Systems 21817.3 Engaging Scientists in Biorisk Management in National Institutional Oversight: Case from the Netherlands 21917.4 Engaging Scientists in Biorisk Management in Community: Case from iGEM 22017.4.1 Engaging Scientists Through iGEM Safety Rules Checklist and Safety Screening System 22117.4.2 Engaging Scientists Through iGEM Human Practices Programme 22217.5 Conclusion: How to Engage Scientists in Management of Biorisk and Other Emerging Fields 223Author Biography 223References 22418 The Role of Ethics in Dealing with Dual Use 225Leifan Wang18.1 The Dual-Use Concept and Concerns 22618.2 Ethics as an Instrument on Dual-Use Governance 22718.2.1 Ethics Promote Responsible Practices on Dual Use 22718.2.2 Limitation of Ethics in Dealing with Dual Use 22918.3 Existing and Complementary Ethical Guidelines on Dual Use 23018.4 Recent Dual-Use Scenarios 23118.4.1 Synthetic Biology 23118.4.2 Gene Editing 23218.4.3 Neuroscience 23218.4.4 Digital Biological Data 23318.5 Ethical Education for Future Dual Use 233Author Biography 234References 23419 Where Is the Governance of Dual-Use Science Going? 237Nancy Connell and Gigi Gronvall19.1 Background: Genetic Technologies and Their Applications 23819.2 Dual-Use Science: Evolving Story of a Dualistic Term 23919.3 Begin with the Experts: Models of Self-regulation 24019.3.1 From Asilomar to Napa 24019.3.2 Tools for Self-regulation: Risk and Benefit Analyses: Useful Frameworks 24119.3.3 A Patchwork of Layered Oversight, from Global to Local 24119.3.4 Self-regulation: The Basis of Scientific Enterprise 24319.3.5 Oversight Along the Life Cycle of Research: Universities Are Sites of Layered Governance 24319.3.6 Toward an International Model: International Collaboration in Science and Technology (ICST) 24419.3.7 International Standards for Biosafety and Biosecurity 24519.4 Alternative Governance Structures 24519.4.1 Hybrid Governance Models 24519.4.2 Network-Based Governance 24619.4.3 Transnational Governance 24619.5 Conclusion 247Author Biography 247References 24820 Towards an International Biosecurity Education Network (IBSEN) 251Kathryn Millett and Lijun Shang20.1 Introduction 25220.2 The Need for Biosecurity Education, Awareness-Raising and a Culture of Responsibility in the Life Sciences 25220.3 Past Efforts in Educating Life Scientists and Establishing a Culture of Responsibility 25320.4 Challenges Faced by Biosecurity Education and Awareness-Raising 25820.5 Comparable Approaches Implemented in Analogous Frameworks in the Nuclear and Chemistry Fields 25920.5.1 IAEA Nuclear Security Culture and the International Nuclear Security Education Network (INSEN) 26020.5.2 Chemical Weapons Convention and the Advisory Board on Education and Outreach (ABEO) 26220.5.3 Key Lessons from the INSEN and ABEO for an International Biosecurity Educational Network (IBSEN) 26420.5.3.1 Comprehensive Understanding Learned from Related Initiatives 26420.5.3.2 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) 26420.5.3.3 Sustained Financial Support Observed and Maintained 26420.5.3.4 Strategic Vision and Clear Pathways Are Required for Communication and Collaboration Between a Network and Treaty Bodies/States 26520.5.3.5 Diversity of Memberships and Engagement with a Wide Range of Stakeholders 26520.6 Conclusion 266Author Biography 267References 268Appendix A: The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists 269Index 273