Biosecurity E-Book

Ryan Burnette

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 493

Veröffentlichungsjahr: 2013

Beschreibung

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.

Leseprobe

Contents

Cover

Half Title page

Title page

Copyright page

Preface

Author Affiliation

Acknowledgments

About the Author

Part I: An Introduction to Biosecurity

Chapter 1: Defining Biosecurity and Related Concepts

What is Bsosecurity?

Related Concepts

Risk Management and Prioritization in Biosecurity

Basic Components of Biosecurity

Conclusion

References

Chapter 2: Biosecurity as a Function of Biosafety Microbiological Laboratories

Introduction

Evolving Steps Towards Biosecurity

Biosecurity is Embedded in Biosafety Programs

Control Access to High-Consequence Pathogens and Toxins

Accountability

Occupational Health Programs

Biosafety Culture

Conclusion

References

Chapter 3: A Perspective of Biosecurity: Past to Present

Introduction

Biological Warfare

Bioterrorism

Biocrime

Bioaccidents

Conclusion

References

Part II: Elements of Biosecurity

Chapter 4: Physical Elements of Biosecurity

Introduction

Protecting and Securing Biological Materials

Breaking Down the Program: The Six Security Capabilities

Architecture, Engineering, and Work Practice Considerations

Operations and Sustainment

Conclusion

References

Chapter 5: Operational Elements of Biosecurity

Introduction

The Biosecurity Process

New Regulatory Requirements

Conclusion

References

Chapter 6: Basic Principles of Threat Assessment

Introduction

A Comprehensive Approach to Biosecurity

Safety Versus Security: Risk Versus Threat

The Purposes and Requirements of Basic Suitability and Threat Assessment Programs

Conclusion

References

Part III: Biosecurity in Various Sectors

Chapter 7: Biosecurity in Research Laboratories

Introduction

Laboratory Biosecurity

The Select agent Program

Conclusion

References

Chapter 8: Biosecurity in the Food and Agricultural Industries

Introduction

The U.S. Food and Agriculture Infrastructure

Food Defense

Food Defense: Protecting U.S. Food and Agriculture from Intentional Disruption

Conclusion

References

Chapter 9: Biosecurity in Mass Transportation Networks

Introduction

Mass Transit Systems and Vulnerabilities

Federal, State, and Local Biosecurity Activities and Planning

Conclusion

References

Chapter 10: Utilizing Biosecurity Principles to Combat Naturally Occurring Epidemics

Introduction

Separating Deliberate Outbreaks from Naturally Occurring Epidemics

The Need for Biosafety and Biosecurity in the Response to a Naturally Occurring Outbreak

Assessing Biosafety and Biosecurity Risks in Public Health: The Science of Biosecurity

Increasing Security Functions Through the Application of Biosecurity to Public Health

Challenges Associated with the International Coordination of Outbreak Response

Biosecurity Impediments to International Health Programs

Conclusion

References

Part IV: Biosecurity Policy, Bioterrorism, and the Future

Chapter 11: Current Efforts to Fortify Biosecurity Policy in the U.S.

Introduction

Emerging Policies Limiting Access to Pathogens and Enhancing Laboratory Security

Policies that Focus on Dual-Use Research of Concern

Evolving Oversight of Synthetic Biology

Conclusion

References

Chapter 12: The Link between Biosecurity and Bioterrorism

Introduction

Bioterrorism Attack Cycle

The Bioterrorism-Biosecurity Nexus

The Biological Criminal Continuum

Conclusion

References

Chapter 13: The Importance of Engagement and Education for Effective Biosecurity

Introduction

Overview of Engagement and Education

Other Intervention Points and Actors

Challenges Moving Forward

Why Bother with Biosecurity-Related Education and Engagement?

Moving Biosecurity Engagement and Education Forward

Conclusion

References

Chapter 14: Monitoring and Evaluating Laboratory Biosafety Programs

Introduction

Need for a Laboratory Biosafety Program Framework

Major Concepts and Definitions

Conceptual Framework

Laboratory Biosafety Indicators

Anticipated Benefits of the Indicator Database

Analytic Processes to Refine Indicators

Limitations

Conclusion

References

Chapter 15: The Future of Biosecurity: A Global Context

Introduction

Biosecurity Summarized

A One World/One Health Model for Biosecurity

Future of Biosecurity

Conclusion

References

Appendix 1: U.S. Food Defense since 9/11: Public Sector Initiatives and Programs

Regulatory and Policy Framework

Government Initiatives and Actions

Conclusion

References

Appendix 2: Timeline of Selected Events in Biosecurity Policy

References

Index

Biosecurity

Copyright © 2013 by The Institute of Electrical and Electronics Engineers, Inc.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey. All rights reserved.Published simultaneously in Canada.

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Library of Congress Cataloging-in-Publication Data:

Biosecurity: understanding, assessing, and preventing the threat / edited by Ryan Burdette.    pages cm  Includes index.  ISBN 978-0-470-61417-4 (hardback)1. Biosecurity. 2. Bioterrorism—Prevention. 3. Biological weapons—Safety measures. I.Burnette, Ryan, 1977–author, editor of compilation.  JZ5865.B56B58 2013  363.325’3—dc23  2013016290

Preface

The term “biosecurity” remained largely obscure to the public until the events of September 11, 2001, followed by the anthrax letters in the same year. Biosecurity, and the concepts it embodies, however, date back well before those fateful events. Yet those events initiated a wave of awareness and concern in the minds of the public and our legislators. Changes took place more rapidly than they ever had before: a new cabinet-level office, the Department of Homeland Security, was formed. Funding of biodefense programs grew exponentially. Stockpiles of vaccines were created. The hunt for novel vaccines and therapeutics against exotic pathogens increased rapidly. In short, the U.S. and much of the world began to prepare for similar events that were believed to be imminent. Despite this surge in activity and awareness, biosecurity remains poorly understood.

As this book will explore, biosecurity is a complex matrix of terminology, concepts, ideals, practices, and policy. Further complicating the concept of biosecurity is the vast number of related terms: bioterrorism, biodefense, bioweapons, and the like are arguably more common in the modern vernacular than the word “biosecurity.” In response, this book begins by disassembling the tenets of biosecurity, breaking it down into its fundamental pieces. Physical and operational biosecurity will be described and the concepts of assessing threats fully detailed. We will explore how biosecurity impacts and is impacted by a variety of industries distinct from the traditional research laboratory. Many of these industries, such as agriculture, mass transit, and public and global health, will receive new attention under the lens of biosecurity. This book will also take a detailed look at current biosecurity policy and where new policy is likely to develop. Potentially for the first time, this book discusses the importance of education and advocacy for biosecurity in frank terms, which may assist researchers in the integration of biosecurity into the educational process. This book also presents a novel tool developed to quantify the effectiveness of laboratory biosafety and biosecurity programs.

The intent of this book is to provide clarity to the term “biosecurity” and demonstrate its relevance to areas that have historically been given little consideration. Finally, this book challenges the reader to look forward, armed with new information about biosecurity, to how biosecurity as an ideal needs to develop and progress. This is not an easy task, but, as this book demonstrates, it is a necessary task.

It is my sincere hope that this book will do two things: provide the reader with a foundation for everything that biosecurity is and is not and compel the reader to think about the importance of biosecurity as it relates to our collective security, safety, and health.

Ryan N. Burnette, Ph.D.December 21, 2012

Author Affiliation

CHAPTER 1 Defining Biosecurity and Related Concepts

Ryan N. Burnette, Ph.D.,1 Jenna E. Hess, M.S.,1

Joseph P. Kozlovac, M.S., SM (NRCM), CBSP,2

Jonathan Y. Richmond, Ph.D., RBP3

1 Alliance Biosciences

2 Agency Biosafety Officer, USDA Agricultural Research Service (ARS), National Program Staff, Animal Production and Protection

3 Jonathan Richmond & Associates

CHAPTER 2 Biosecurity as a Function of Biosafety for Microbiological Laboratories

Jonathan Y. Richmond, Ph.D., RBP,1 Ryan N. Burnette, Ph.D.,2 Gigi Kwik Gronvall, Ph.D.3

1 Jonathan Richmond & Associates

2 Alliance Biosciences

3 Center for Biosecurity, University of Pittsburgh Medical Center

CHAPTER 3 A Perspective of Biosecurity: Past to Present

Robert J. Hawley, Ph.D., RBP, SM (NRCM), CBSP,1

Joseph P. Kozlovac, M.S., SM (NRCM), CBSP2

1 Alliance Biosciences

2 Agency Biosafety Officer, USDA Agricultural Research Service (ARS), National Program Staff, Animal Production and Protection

CHAPTER 4 Physical Elements of Biosecurity

Jeff Slayton,1 Daniel N. Apple, and Benjamin A. Perman, Ph.D., PPS,2

1 Gregg Protection Services; American Biological Safety Association, Texas Association of Hostage Negotiators

2 Booz Allen Hamilton, Inc.

CHAPTER 5 Operational Elements of Biosecurity

J. Craig Reed, Ph.D., RBP,1 and Debra C. Sharpe, MPH, CCHO, RBP2

1 Alliance Biosciences

2 The Working Buildings Companies, LLC

CHAPTER 6 Basic Principles of Threat Assessment

Benjamin A. Perman, Ph.D., PPS,1 Lindsay T. Odell, Ph.D.,1 Jason Griffeth,1 and Daniel N. Apple

1 Booz Allen Hamilton, Inc.

CHAPTER 7 Biosecurity in Research Laboratories

Kavita M. Berger, Ph.D.1

1 Center for Science, Technology, and Security Policy, American Association for the Advancement of Science

CHAPTER 8 Biosecurity in the Food and Agricultural Industries

Henry S. Parker, Ph.D.1

1 Georgetown University Medical Center, Department of Microbiology and Immunology, Washington, DC

CHAPTER 9 Biosecurity in Mass Transportation Networks

Brian K. George1

1 The Tauri Group, LLC

CHAPTER 10 Biosecurity in Mass Transportation Networks

J. Craig Reed, Ph.D., RBP,1 Robert A. Heckert, BSc(Agr), DVM, Ph.D., CBSP, SM(NRCM),2 Patricia Delarosa, Ph.D., RBP, CBSP,3 and Vera Ettenger, Ph.D., RBP, CBSP3

1 Alliance Biosciences

2 Robert Heckert Consulting

3 Booz Allen Hamilton, Inc.

CHAPTER 11 Current Efforts to Fortify Biosecurity Policy in the U.S.

Gigi Kwik Gronvall, Ph.D.1

1 Center for Biosecurity, University of Pittsburgh Medical Center

CHAPTER 12 The Link between Biosecurity and Bioterrorism

Daniel N. Apple and Benjamin A. Perman, Ph.D., PPS1

1 Booz Allen Hamilton, Inc.

CHAPTER 13 The Importance of Engagement and Education for Effective Biosecurity

James Revill, Ph.D.,1 and Catherine Jefferson, Ph.D.2

1 Harvard Sussex Program, University of Sussex

2 Kings College, London

CHAPTER 14 Monitoring and Evaluating Laboratory Biosafety Programs

Heather N. Meeks, Ph.D.1, Betiel H. Haile, M.P.H.1, Ngozi Erondu, M.P.H.2, Lisa Ferland, M.P.H.2, Meeyoung Park, M.P.H.2, Affan Shaikh, M.P.H.2, and Scott J.N. McNabb, Ph.D., M.S.2,,3

1 Defense Threat Reduction Agency, Basic and Applied Sciences

2 Public Health Practice, LLC

3 Emory University, Rollins School of Public Health

CHAPTER 15 The Future of Biosecurity: A Global Context

Ryan N. Burnette, Ph.D.1, J. Craig Reed, Ph.D., RBP,1 and Patricia Delarosa, Ph.D., RBP, CBSP2

1 Alliance Biosciences

2 Booz Allen Hamilton, Inc.

APPENDIX 1 U.S. Food Defense since 9/11: Public Sector Initiatives and Programs

Henry S. Parker, Ph.D.1

1 Georgetown University Medical Center, Department of Microbiology and Immunology, Washington, DC

APPENDIX 2 Timeline of Selected Events in Biosecurity Policy

Gigi Kwik Gronvall, Ph.D.1

1 Center for Biosecurity, University of Pittsburgh Medical Center

Acknowledgments

It is imperative to stress that nothing about managing and editing a volume such as this one is an independent exercise, and there have been many helpful hands to assist in guiding the process. At the same time as it goes without saying, the overwhelming majority of thanks must be given to the authors of and contributors to this manuscript. They have committed countless hours of their lives to crafting useful information that we all hope will be well received and well utilized. For their commitment to this project, I am eternally grateful. I can safely admit that I am nowhere near expert enough to have drafted the content that was generously contributed.

Jenna E. Hess, M.S., presented as an author and co-editor of this volume, was instrumental in the overall process. Her attention to detail and writing skills have resulted in a much better product than it would have been if left to my own devices. Her instincts are solid and were brought to bear in this project.

J. Craig Reed, Ph.D., RBP, is easily one of the greatest “team players” not only on my company’s staff, but on this project as well. He contributed more content than any other single author, rolled with all the punches, and even provided editorial assistance on several chapters. Craig’s viewpoints helped shape the way many of the topics were presented, even changing my own mind more than once.

Time is always a factor when drafting such a volume, and yet is it something we are all in need of. I was provided the time to manage this effort in a large part thanks to the understanding and patience of the owners of my company. Jim Burnette and Kevin Kokal have been tremendously supportive, both of my time requirements, and of the vision to see the effort to completion. I am grateful to both for many reasons beyond the scope of this book as well. In fact, this effort would not have been possible without their unwavering commitment to me as the company has grown. Had they not had confidence in me years ago, the opportunity to create this book would never have arisen.

My introduction to biosecurity truly began in the field of biosafety, which is discussed at length in this book. I owe a great deal of thanks (and admiration) to the mentors I have had in this field. A single phone call changed my career when Jonathan Y. Richmond, Ph.D., RBP, politely answered. And thus began my career in the world of biosafety and biosecurity. His steady, consistent mentorship has literally made me the professional I am today. I am flattered to be able to call one of the true fathers of the industry a friend. Likewise, Robert (Bob) Hawley, Ph.D., RBP, CBSP, SM(NRCM), and Robert Heckert, DVM, Ph.D., RBP, CBSP, SM(NRCM), have both spent considerable time providing me with education and insight. Marian Downing, RBP, CBSP, SM(NRCM), has been by my side, supporting and guiding me for more years than any one person in this field. She too has rolled with more punches than I ever thought I would throw, yet she is still dedicated and here. Christina Thompson, M.S., RBP, CBSP, SM(NRCM), referred me to Marian and therefore to a large part of who I am today. Chris remains a true team player, consultant, and friend.

Daniel N. Apple and Benjamin A. Perm would like to thank the following individuals for substantive contributions to the development of the materials and ideas presented in Chapter 6: Chuck Tobin; Dr. Ronald Schouten; Dr. Tricia De La Rosa, RBP, CBSP; Dr. Vera Ettenger, RBP, CBSP; Susan Weekly; Dr. Casey Skvorc; Supervisory Special Agent Edward You; and Dr. Nanda Gudderra. The authors also thank John Page for valuable editorial comments on the manuscript. We would also like to thank our friends in the Republics of Azerbaijan, Georgia, Kazakhstan, Ukraine, and Uzbekistan and the Russian Federation, who have taught us more about biosecurity than they may realize.

Virginia (Ginny) Howe has been there through the entire process, carefully answering my questions and guiding the entire process. I owe a great deal of thanks to her and the late Roger Woodson.

For more than one reason, I owe a great deal of thanks to Kady Dudley. She has been supportive of the process and the time involved and has remained by my side to see it through. Likewise, Jim and Melinda Burnette remain the origin of so many opportunities that ultimately led to this book.

Ryan N. Burnette, Ph.D.December 27, 2012

About the Author

Ryan N. Burnette, Ph.D. is the Director of Alliance Biosciences, a laboratory design and biorisk management consulting firm headquartered in Virginia. Alliance provides laboratory design and biorisk management services to private industry, academia and government institutions in the U.S. and more than a dozen countries. In addition to serving as a biosafety and biosecurity consultant, Dr. Burnette has published in the fields of molecular biology, endocrinology and infectious disease. Dr. Burnette previously held positions in the Departments of Biology and Biochemistry at Virginia Tech, and the Department of Molecular Physiology and Biophysics at Vanderbilt University School of Medicine prior to creating Alliance Biosciences. For more information, please visit www.AllianceBiosciences.com.

PART I

AN INTRODUCTION TO BIOSECURITY

CHAPTER 1

Defining Biosecurity and Related Concepts

Ryan N. Burnette, Jenna E. Hess, Joseph P. Kozlovac, and Jonathan Y. Richmond

WHAT IS BIOSECURITY?

Biological security, or “biosecurity,” is not easy to define and elicits a variety of interpretations. Thus, it is important to clearly define the context in which the term is used. In a broad sense, it is a “strategic and integrated approach, encompass[ing] the policy and regulatory frameworks that analyze and manage risks in the sectors of food safety, animal life and health, and plant life and health, including associated environmental risk.”1 However, biosecurity is not limited to policy and regulation, as this book demonstrates. For the purpose of defining biosecurity, this chapter focuses on elements of laboratory biosecurity.

Laboratory biosecurity is a [set of] concepts and practices used to secure sensitive biological materials from persons or entities that should not have access.2 The World Health Organization (WHO) refers to “laboratory biosecurity … [as the] institutional and personal security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens and toxins.”3 Biosecurity is not strictly limited to biological agents or harmful byproducts. It also applies to products having intrinsic value, such as novel vaccines, biological therapeutics, information-technology platforms, synthetic nanoparticles or organisms, and products having high monetary value or related to biological agents. These will be referenced throughout this book as valuable biological material, or VBM.

Biosecurity as a field likely originated from its applications in controlling the release of genetically modified organisms, or GMOs, into indigenous environmental populations.4 As with other condensed “bio” terms, the inclusion of the word “biosecurity” into popular vernacular was firmly established following the attacks of September 11, 2001. The Centers for Disease Control and Prevention (CDC) and the National Institute of Health (NIH) recognize that a robust biosafety program includes many facets of biosecurity and that it assumes many definitions. For example, biosecurity in the animal industry is the protection of animal colonies from microbial contamination.