Biosecurity: Understanding, Assessing, and Preventing the Threat

Learn how to assess and prevent biosecurity threats to protect public health and national security With contributions from experts in all facets of biosecurity, this book explains the fundamental elements of biosecurity as well as the related concepts of biosafety and biosurety, detailing how all three concepts fit within the framework of biodefense. Readers are then given the tools needed to assess and prevent biosecurity threats and vulnerabilities. The book explores the nature of biosecurity threats to research laboratories as well as to agriculture, food, and mass transit. Moreover, readers will learn how to apply principles of biosecurity to assess epidemics and protect public health. Biosecurity takes a detailed look at today's biosecurity policy, explaining how it is likely to evolve given current and potential threats to national security. The authors stress the importance of education and advocacy, helping readers develop effective programs to build public awareness and preparedness. The book also presents a novel tool to assess the effectiveness of laboratory biosafety and biosecurity programs. Biosecurity is divided into four parts: Part I: An Introduction to Biosecurity Part II: Elements of Biosecurity Part III: Biosecurity in Various Sectors Part IV: Biosecurity Policy, Bioterrorism, and the Future This book will instill a deep understanding of what biosecurity is and what it is not. It urges readers to think about the importance of biosecurity as it relates to national security, safety, and health. By exposing major flaws in global biosecurity thinking, Biosecurity sets forth a clear pathway to correct those errors and build stronger biosecurity programs.

Preface ix Author Affiliation xi Acknowledgments xv About the Author xix PART I An Introduction to Biosecurity 1 Chapter 1 Defining Biosecurity and Related Concepts 3 Ryan Burnette, Jenna Hess, Joseph Kozlovac, and Jonathan Richmond What is Biosecurity? 3 Related Concepts 4 Risk Management and Prioritization in Biosecurity 12 Basic Components of Biosecurity 13 Conclusion 14 Chapter 2 Biosecurity as a Function of Biosafety Microbiological Laboratories 17 Jonathan Y. Richmond, Ryan Burnette, Gigi Kwik Gronvall Introduction 17 Evolving Steps towards Biosecurity 18 Biosecurity is Embedded in Biosafety Programs 20 Control Access to High–Consequence Pathogens and Toxins 22 Accountability 22 Occupational Health Programs 23 Biosafety Culture 23 Conclusion 24 Chapter 3 A Perspective of Biosecurity: Past to Present 27 Robert J. Hawley and Joseph P. Kozlovac Introduction 27 Biological Warfare 28 Bioterrorism 30 Biocrime 34 Bioaccidents 37 Conclusion 41 PART II E LEMENTS OF BIOSECURITY 49 Chapter 4 Physical Elements of Biosecurity 51 Jeff Slayton, Daniel N. Apple, and Ben Perman Introduction 51 Protecting and Securing Biological Materials 51 Breaking Down the Program: The Six Security Capabilities 58 Architecture, Engineering and Work Practice Considerations 63 Operations and Sustainment 67 Conclusion 70 Chapter 5 Operational Elements of Biosecurity 71 J. Craig Reed, and Debra C. Sharpe Introduction 71 The Biosecurity Process 72 Biosecurity Challenges Associated with Different Institutions 82 New Regulatory Requirements 84 Conclusion 87 Chapter 6 Basic Principles of Threat Assessment 89 Ben Perman, Lindsay T. Odell, Jason Griffeth, and Daniel N. Apple Introduction 89 A Comprehensive Approach to Biosecurity 89 Safety versus Security: Risk vesus Threat 90 The Purposes and Requirements of Basic Suitability and Threat Assessment Programs 102 Conclusion 108 PART III BIOSECURITY IN VARIOUS SECTORS 111 Chapter 7 Biosecurity in Research Laboratories 113 Kavita M. Berger Introduction 113 Laboratory Biosecurity 114 The Select Agent Program 115 Conclusion 122 Chapter 8 Biosecurity in the Food and Agricultural Industries 129 Henry S. Parker Introduction 129 The U.S. Food and Agriculture Infrastructure 129 Food Defense 132 Food Defense: Protecting U.S. Food and Agriculture from Intentional Disruption 145 Conclusion 150 Chapter 9 Biosecurity in Mass Transportation Networks 155 Brian K. George Introduction 155 Mass Transit Systems and Vulnerabilities 155 Federal, State, and Local Biosecurity Activities and Planning 157 Conclusion 164 Chapter 10 Utilizing Biosecurity Principles to Combat Naturally Occurring Epidemics 167 J. Craig Reed, Robert A. Heckert, Patricia Delarosa, and Vera Ettenger Introduction 167 Separating Deliberate Outbreaks from Naturally Occurring Epidemics 168 The Need for Biosafety and Biosecurity in the Response to a Naturally Occurring Outbreak 169 Assessing Biosafety and Biosecurity Risks in Public Health: The Science of Biosecurity 172 Increasing Security Functions through the Application of Biosecurity to Public Health 174 Challenges Associated with the International Coordination of Outbreak Response 175 Biosecurity Impediments to International Health Programs 178 Conclusion 180 PART IV BIOSECURITY POLICY, BIOTERRORIS M AND THE FUTURE 185 Chapter 11 Current Efforts to Fortify Biosecurity Policy in the U.S. 187 Gigi Kwik Gronvall Introduction 187 Emerging Policies Limiting Access to Pathogens and Enhancing Laboratory Security 188 Policies that Focus on Dual–Use Research of Concern 191 Evolving Oversight of Synthetic Biology 192 Conclusion 194 Chapter 12 The Link between Biosecurity and Bioterrorism 197 Daniel N. Apple and Benjamin A. Perman Introduction 197 Bioterrorism Attack Cycle 197 The Bioterrorism–Biosecurity Nexus 202 The Biological Criminal Continuum 204 Conclusion 206 Chapter 13 The Importance of Engagement and Education for Effective Biosecurity 209 James Revill and Catherine Jefferson Introduction 209 Overview of Engagement and Education 209 Other Intervention Points and Actors 213 Challenges Moving Forward 215 Why Bother with Biosecurity–Related Education and Engagement? 216 Moving Biosecurity Engagement and Education Forward 218 Conclusion 221 Chapter 14 Monitoring and Evaluating Laboratory Biosafety Programs 225 Heather N. Meeks, Betiel H. Haile, Ngozi Erondu, Lisa Ferland, Meeyoung Park, Affan Shaikh, and Scott J.N. McNabb Introduction 225 Need for a Laboratory Biosafety Program Framework 227 Major Concepts and Definitions 230 Conceptual Framework 239 Laboratory Biosafety Indicators 241 Anticipated Benefits of the Indicator Database 242 Analytic Processes to Refine Indicators 242 Limitations 254 Conclusion 254 Chapter 15 The Future of Biosecurity: A Global Context 259 Ryan N. Burnette, J. Craig Reed, and Patricia Delarosa Introduction 259 Biosecurity Summarized 259 A One World/One Health Model for Biosecurity 262 Future of Biosecurity 266 Conclusion 267 APPENDIX 1 U.S. Food Defense since 9/11: Public Sector Initiatives and Programs 271 Henry S. Parker APPENDIX 2 Timeline of Selected Events in Biosecurity Policy 289 Gigi Kwik Gronvall Index 299

RYAN BURNETTE, PhD, is Director of Alliance Biosciences, a consulting firm with expertise in laboratory design, operational management, and biorisk management. He lectures and conducts training on biorisk management, biosafety, and biosecurity in the United States and around the world. Dr. Burnette has held positions at Virginia Tech and Vanderbilt University School of Medicine.