Table of Contents

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

About the Author

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.