Select Agents are defined in regulations through a list of names of particularly dangerous known bacteria, viruses, toxins, and fungi. However, natural variation and intentional genetic modification blur the boundaries of any discrete Select Agent list based on names. Access to technologies that can generate or 'synthesize' any DNA sequence is expanding, making it easier and less expensive for researchers, industry scientists, and amateur users to create organisms without needing to obtain samples of existing stocks or cultures. This has led to growing concerns that these DNA synthesis technologies might be used to synthesize Select Agents, modify such agents by introducing small changes to the genetic sequence, or create entirely new pathogens. Amid these concerns, the National Institutes of Health requested that the Research Council investigate the science and technology needed to replace the current Select Agent list with an oversight system that predicts if a DNA sequence could be used to produce an organism that should be regulated as a Select Agent. A DNA sequence-based system to better define when a pathogen or toxin is subject to Select Agent regulations could be developed. This could be coupled with a 'yellow flag' system that would recognize requests to synthesize suspicious sequences and serve as a reference to anyone with relevant questions, allowing for appropriate follow-up. Sequence-Based Classification of Select Agents finds that replacing the current list of Select Agents with a system that could predict if fragments of DNA sequences could be used to produce novel pathogens with Select Agent characteristics is not feasible. However, it emphasized that for the foreseeable future, any threat from synthetic biology and synthetic genomics is far more likely to come from assembling known Select Agents, or modifications of them, rather than construction of previously unknown agents. Therefore, the book recommends modernizing the regulations to define Select Agents in terms of their gene sequences, not by their names, and called this 'sequence-based classification.'

The effort to understand and combat infectious diseases has, during the centuries, produced many key advances in science and medicine-including the development of vaccines, drugs, and other treatments. A subset of this research is conducted with agents that, like anthrax, not only pose a severe threat to the health of humans, plants, and animals but can also be used for ill-intended purposes. Such agents have been listed by the government as biological select agents and toxins. The 2001 anthrax letter attacks prompted the creation of new regulations aimed at increasing security for research with dangerous pathogens. The outcome of the anthrax letter investigation has raised concern about whether these measures are adequate. Responsible Research with Biological Select Agents and Toxins evaluates both the physical security of select agent laboratories and personnel reliability measures designed to ensure the trustworthiness of those with access to biological select agents and toxins. The book offers a set of guiding principles and recommended changes to minimize security risk and facilitate the productivity of research. The book recommends fostering a culture of trust and responsibility in the laboratory, engaging the community in oversight of the Select Agent Program, and enhancing the operation of the Select Agent Program.

A framework for assessing the security risks of emerging dual-use technologies and devising tailored governance strategies is proposed and applied to contemporary case studies. Recent advances in disciplines such as biotechnology, nanotechnology, and neuropharmacology entail a “dual-use dilemma” because they promise benefits for human health and welfare yet pose the risk of misuse for hostile purposes. The emerging field of synthetic genomics, for example, can produce custom DNA molecules for life-saving drugs but also makes possible the creation of deadly viral agents for biological warfare or terrorism. The challenge for policymakers is to prevent the misuse of these new technologies without forgoing their benefits. Innovation, Dual Use, and Security offers a systematic approach for managing the dual-use dilemma. The book presents a “decision framework” for assessing the security risks of emerging technologies and fashioning governance strategies to manage those risks. This framework is applied to fourteen contemporary case studies, including synthetic genomics, DNA shuffling and directed evolution, combinatorial chemistry, protein engineering, immunological modulation, and aerosol vaccines. The book also draws useful lessons from two historical cases: the development of the V-series nerve agents in Britain and the use and misuse of LSD by the U.S. Army and the CIA. Innovation, Dual Use, and Security offers a comprehensive, multifaceted introduction to the challenges of governing dual-use technologies in an era of rapid innovation. The book will be of interest to government officials and other practitioners as well as to students and scholars in security studies, science and technology studies, biology, and chemistry.

This first volume of a two-volume set describes general aspects, such as the historical view on the topic, the role of information distribution and preparedness of health-care systems and preparedness in emergency cases. Part two describes and discusseses in detail the pathogens and toxins that are potentially used for biological attacks. As such, the book is a valuable resource for faculties engaged in molecular biology, genetic engineering, neurology, biodefense, biosafety & biosecurity, virology, and infectious disease programs, as well as professional medical research organizations.

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.

Synthetic biology is a field of biotechnology that is rapidly growing in various applications, such as in medicine, environmental sustainability, and energy production. However these technologies also have unforeseen risks and applications to humans and the environment. This open access book presents discussions on risks and mitigation strategies for these technologies including biosecurity, or the potential of synthetic biology technologies and processes to be deliberately misused for nefarious purposes. The book presents strategies to prevent, mitigate, and recover from 'dual-use concern' biosecurity challenges that may be raised by individuals, rogue states, or non-state actors. Several key topics are explored including opportunities to develop more coherent and scalable approaches to govern biosecurity from a laboratory perspective up to the international scale and strategies to prevent potential health and environmental hazards posed by deliberate misuse of synthetic biology without stifling innovation. The book brings together the expertise of top scholars in synthetic biology and biotechnology risk assessment, management, and communication to discuss potential biosecurity governing strategies and offer perspectives for collaboration in oversight and future regulatory guidance.

A comprehensive introduction to the history, theory, and policy implications of self-governance in commercial and academic science communities.

The Transformational Medical Technologies (TMT) has been a unique component of the U.S. Department of Defense (DoD) medical biodefense efforts since 2006. Its mission is to advance countermeasure research and development in support of the broader goal of the DoD to protect warfighters from emerging infectious diseases and future genetically engineered biological weapons. The TMT, using advanced science and technology approaches, focused on the development of roadspectrum countermeasures that target common host and pathogen pathways or enhance the host's immune response. Many of these pathogens are lethal or cause such debilitating diseases in humans that it is ethically inappropriate to test the efficacy of these countermeasures in human volunteers. In lieu of human participants, these products may be tested in animals and approved for human use under the provisions of the Food and Drug Administration (FDA)'s 2002 Animal Rule. The reliance on animal models for the development and licensure of medical countermeasures against biothreats is challenging for a number of reasons. The ad hoc Committee on Animal Models for Assessing Countermeasures to Bioterrorism Agents prepared a consensus report that would address the challenges stemming from developing and testing medical countermeasures against biothreat agents in animal models. Animal Models for Assessing Countermeasures to Bioterrorism Agents evaluates how well the existing TMT-employed or candidate animal models reflect the pathophysiology, clinical picture, and treatment of human disease as related to the agents of interest. The report addresses the process and/or feasibility of developing new animal models for critical biodefense research, placing emphasis on the need for a robust and expeditious validation process in terms of the FDA's Animal Rule. The report also evaluates alternatives to the use of animal models based on the premise of the Three Rs.

The United States and India have pledged to deepen the linkages between their people, their businesses, and their governments for the mutual benefit of both countries and for the promotion of global peace, stability, economic growth and prosperity. Both nations are now inclined to improve relations and cooperation, but the nations need specific actions that will yield progress and build confidence and momentum for further cooperation. The Indo-U.S. Workshop on Challenges of Emerging Infections and Global Health Safety, held in November 2014, encouraged scientists from both countries to examine global issues related to emerging and existing infections and global health safety, to share experience and approaches, and to identify opportunities for cooperation to improve practice and research in these areas. This report summarizes the presentations and discussions from the workshop.

This volume is based on a multidisciplinary approach towards biological and chemical threats that can, and have been previously used in bioterrorism attacks around the globe. Current knowledge and evidence-based principles from the fields of synthetic biology, microbiology, plant biology, chemistry, food science, forensics, tactics, infective medicine, psychology and others are compiled to address numerous aspects and the complexity of bioterrorism attacks. The main focus is on biological threats, especially in the context of synthetic biology and its emerging findings that can be observed as possible threat and tool. The book examines microorganisms and their possible use in forensics, i.e. as possible detection tool that could enable fast and precise detection of possible treats. A number of plant derived components are also discussed as possible agents in bioterrorism attacks, and in relation to infectious disease pathology. Another integral part is food safety, especially in terms of large food supply chains, like airline caterings, institutionalized kitchens etc. Food can be observed as a possible mean of delivery of various agents (biological and chemical) for bioterrorism attacks. Steps on how to recognize specific critical points in a food supply chain, along with proposed corrective activities are discussed. Examples from around the globe, along with the methodological approach on how to differentiate bioterrorism attacks from other epidemics are provided. However, epidemics are also discussed in the context of migrations, with the special emphasis on the current refugee migrations that affect not only Europe, but also the United States. The book will be of interest to experts from various fields of science as well as professionals working in the field. The book encompasses examples and tools developed for easier, more specific, and faster detection of possible bioterrorism treats, along with proposed actions for some aspects of a bioterrorism attack.