Over the past two decades bioscience facilities worldwide have experienced multiple safety and security incidents, including many notable incidents at so-called sophisticated facilities in North America and Western Europe. This demonstrates that a system based solely on biosafety levels and security regulations may not be sufficient. Setting the stage for a substantively different approach for managing the risks of working with biological agents in laboratories, Laboratory Biorisk Management: Biosafety and Biosecurity introduces the concept of biorisk management--a new paradigm that encompasses both laboratory biosafety and biosecurity. The book also provides laboratory managers and directors with the information and technical tools needed for its implementation. The basis for this new paradigm is a three-pronged, multi-disciplinary model of assessment, mitigation, and performance (the AMP model). The application of the methodologies, criteria, and guidance outlined in the book helps to reduce the risk of laboratories becoming the sources of infectious disease outbreaks. This is a valuable resource for those seeking to embrace and implement biorisk management systems in their facilities and operations, including the biological research, clinical diagnostic, and production/manufacturing communities.

Over the past two decades bioscience facilities worldwide have experienced multiple safety and security incidents, including many notable incidents at so-called "sophisticated facilities" in North America and Western Europe. This demonstrates that a system based solely on biosafety levels and security regulations may not be sufficient. Setting the stage for a substantively different approach for managing the risks of working with biological agents in laboratories, Laboratory Biorisk Management: Biosafety and Biosecurity introduces the concept of biorisk management—a new paradigm that encompasses both laboratory biosafety and biosecurity. The book also provides laboratory managers and directors with the information and technical tools needed for its implementation. The basis for this new paradigm is a three-pronged, multi-disciplinary model of assessment, mitigation, and performance (the AMP model). The application of the methodologies, criteria, and guidance outlined in the book helps to reduce the risk of laboratories becoming the sources of infectious disease outbreaks. This is a valuable resource for those seeking to embrace and implement biorisk management systems in their facilities and operations, including the biological research, clinical diagnostic, and production/manufacturing communities.

The increasing risk of naturally occurring and intentionally introduced infectious disease makes the existing approaches to laboratory biosafety and biosecurity no longer adequate. Biorisk management emphasizes the need for a comprehensive, laboratory-specific method to simultaneously reduce both the safety and security risks associated with biological agents in a laboratory. This volume introduces this new field and explains how to implement it. The book sets the stage for a radically different understanding of how to reduce the risks of working with biological agents in laboratories, based on a new paradigm of assessment, mitigation, and performance (the AMP model).

This book describes an adaptable biothreat assessment process to complement overall biorisk management programs, incorporating threat management and the unique natures of biological assets. Further, this book examines the nexus between public health, international security, and developing technologies, building a case for augmenting biosecurity to levels beyond the laboratory constraints. With the face of biological and biomedical sciences changing, this book describes how with proper biosecurity development, these can become assets, rather than liabilities, to secure our world from natural and man-made biological disasters. The world is changing rapidly with respect to developing threats, such as terrorism, and dual-use technologies, such as synthetic biology, that are challenging how we think about biosafety and biosecurity. Further, the fields of public health and international security are colliding, as both of these share the common enemy: intentional or natural biological incidents. To date, biosecurity has been limited to laboratory-level application, and complicating efforts, and lacks credentialed biosecurity professionals skilled in both the biological sciences and threat management techniques. The result is a fragmented field of practice, with tremendous need, from the lab to the outbreak. Underpinning these principles is the SARS-CoV-2 coronavirus pandemic, providing a historic milestone to examine biosecurity through a global lens. This book describes biosecurity as a set of practices and principles to be augmented out of the constrained laboratory environment, and applied to larger efforts, such as international threat reduction and biological incident management.

Biological safety and biosecurity protocols are essential to the reputation and responsibility of every scientific institution, whether research, academic, or production. Every risk—no matter how small—must be considered, assessed, and properly mitigated. If the science isn't safe, it isn't good. Now in its fifth edition, Biological safety: Principles and Practices remains the most comprehensive biosafety reference. Led by editors Karen Byers and Dawn Wooley, a team of expert contributors have outlined the technical nuts and bolts of biosafety and biosecurity within these pages. This book presents the guiding principles of laboratory safety, including: the identification, assessment, and control of the broad variety of risks encountered in the lab; the production facility; and, the classroom. Specifically, Biological Safety covers protection and control elements—from biosafety level cabinets and personal protection systems to strategies and decontamination methods administrative concerns in biorisk management, including regulations, guidelines, and compliance various aspects of risk assessment covering bacterial pathogens, viral agents, mycotic agents, protozoa and helminths, gene transfer vectors, zooonotic agents, allergens, toxins, and molecular agents as well as decontamination, aerobiology, occupational medicine, and training A resource for biosafety professionals, instructors, and those who work with pathogenic agents in any capacity, Biological safety is also a critical reference for laboratory managers, and those responsible for managing biohazards in a range of settings, including basic and agricultural research, clinical laboratories, the vivarium, field study, insectories, and greenhouses.

During July 10-13, 2011, 68 participants from 32 countries gathered in Istanbul, Turkey for a workshop organized by the United States National Research Council on Anticipating Biosecurity Challenges of the Global Expansion of High-containment Biological Laboratories. The United States Department of State's Biosecurity Engagement Program sponsored the workshop, which was held in partnership with the Turkish Academy of Sciences. The international workshop examined biosafety and biosecurity issues related to the design, construction, maintenance, and operation of high-containment biological laboratories- equivalent to United States Centers for Disease Control and Prevention biological safety level 3 or 4 labs. Although these laboratories are needed to characterize highly dangerous human and animal pathogens, assist in disease surveillance, and produce vaccines, they are complex systems with inherent risks. Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories summarizes the workshop discussion, which included the following topics: Technological options to meet diagnostic, research, and other goals; Laboratory construction and commissioning; Operational maintenance to provide sustainable capabilities, safety, and security; and Measures for encouraging a culture of responsible conduct. Workshop attendees described the history and current challenges they face in their individual laboratories. Speakers recounted steps they were taking to improve safety and security, from running training programs to implementing a variety of personnel reliability measures. Many also spoke about physical security, access controls, and monitoring pathogen inventories. Workshop participants also identified tensions in the field and suggested possible areas for action.

What Is the Dual-Use Dilemma? The so-called “dual-use dilemma” arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of sci- tific research sometimes has the potential to be used for harm as well as for good. A dual-use dilemma is an ethical dilemma, and an ethical dilemma for the researcher (and for those who have the power or authority to assist or impede the researcher’s work, e. g. , governments). It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e. g. , the p- motion of health in the context of providing the wherewithal for the killing of in- cents. It is an ethical dilemma for the researcher not because he or she is aiming at anything other than a good outcome; typically, the researcher intends no harm, but only good. Rather, the dilemma arises for the researcher because of the potential actions of others. Malevolent non-researchers might steal dangerous biological agents produced by the researcher; alternatively, other researchers—or at least their governments or leadership—might use the results of the original researcher’s work for malevolent purposes. The malevolent purposes in question include bioterrorism, biowarfare and blackmail for financial gain.