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.'

In 1980, the World Health Organization (WHO) officially declared that smallpox had been eradicated. In 1986, WHO's international Ad Hoc Committee on Orthopox Virus Infections unanimously recommended destruction of the two remaining official stocks of variola virus, one at the Centers for Disease Control and Prevention and the other at the VECTOR laboratory in Siberia. In June 1999, WHO decided to delay the destruction of these stocks. Informing that decision was Assessment of Future Scientific Needs for Variola Virus, which examines: Whether the sequenced variola genome, vaccinia, and monkey pox virus are adequate for future research or whether the live variola virus itself is needed to assist in the development of antiviral therapies. What further benefits, if any, would likely be gained through the use of variola in research and development efforts related to agent detection, diagnosis, prevention, and treatment. What unique potential benefits, if any, the study of variola would have in increasing our fundamental understanding of the biology, host-agent interactions, pathogenesis, and immune mechanisms of viral diseases.

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.

Megaplasmids are extrachromosomal genetic elements in the size range of 100 kb and larger. They are found in physiologically and phylogenetically diverse groups of bacteria and archaea. By definition, megaplasmids are not essential for the viability of their hosts under all growth conditions, but paradoxically many megaplasmids carry the genetic information for the defining and characteristic traits of the organism in which they reside. Microbial Megaplasmids reviews our knowledge of the extensively studied representatives, such as the catabolic plasmids of the pseudomonads, the rhizobial Sym plasmids, the Ti plasmids of the genus Agrobacterium and the giant enterobacterial virulence plasmids. It also presents snapshots of more recently discovered megaplasmids. The contribution of megaplasmids to the biology of their hosts is described, highlighting the interactions between megaplasmid and chromosomal genes.

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

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.

Microbial Forensics is a rapidly evolving scientific discipline. In the last decade, and particularly due to the anthrax letter attacks in the United States, microbial forensics has become more formalized and has played an increasingly greater role in crime investigations. This has brought renewed interest, development and application of new technologies, and new rules of forensic and policy engagement. It has many applications ranging from biodefense, criminal investigations, providing intelligence information, making society more secure, and helping protect precious resources, particularly human life. A combination of diverse areas is investigated, including the major disciplines of biology, microbiology, medicine, chemistry, physics, statistics, population genetics, and computer science. Microbial Forensics, Second Edition is fully revised and updated and serves as a complete reference of the discipline. It describes the advances, as well as the challenges and opportunities ahead, and will be integral in applying science to help solve future biocrimes. - A collection of microbiology, virology, toxicology and mycology as it relates to forensics, in one reference - New and expanded content to include statistical analysis of forensic data and legal admissibility and the standards of evidence, to name a few - Includes research information and application of that research to crime scene analysis, which will allow practitioners to understand and apply the knowledge to their practice with ease

Reflecting the critical threat posed by biological warfare and terrorism in a post 9-11 world, Medical Aspects of Biological Warfare, 2e, addresses the weaponization of biological agents, categorizing potential agents as food, waterborne, or agricultural agents or toxins, and discusses their respective epidemiology. Recent advances in biomedical knowledge are presented that include descriptions of individual agents and the illnesses induced. Authors discuss biotoxins and explain methods for early identification for anthrax, plague, smallpox, alphaviruses, and staphylococcal enterotoxins. Case studies and research on successful management practices, treatments, and antidotes are also included. Contains updated and revised material since previous, 2007 edition.(Previous Print Hardcover ISBN: 9780160797316; eBook: 9780160872389) Related products: More published products by The Borden Institute, U.S. Army Medical Department (AMEDD) are here: https://bookstore.gpo.gov/agency/army-medical-department-amedd Arms & Weapons collection is available here: https://bookstore.gpo.gov/catalog/arms-weapons Click here to find resources about Hazardous Materials (HAZMAT & CBRNE). Find more Physician References and Medical Handbooks here: https://bookstore.gpo.gov/catalog/physician-references-medical-handbooks

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.