Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safetyâ€"and more.

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.

The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.

As an industry, biotechnology may be likened to the Hymn Book, being both ancient and modern. Whereas activities such as baking, brewing, the fermenting of foods date from our earliest attempts to control and utilise the environment, the application of recombinant DNA technology is recognised as being at the forefront of novel industrial development. Perhaps because of its association with processing foodstuffs together with the benefits derived from applications in the early organic chemistry and pharmaceutical industries, biotechnology has been regarded as being inherently safe. Yet unlike other modern industries, such as chemical and nuclear, where regulation has followed from incidents or accidents, modern biotechnology has been subject to close scrutiny and regulation almost from its inception. The process of regulation itself is somewhat unusual in that it was initially self-imposed by the very scientists who developed the fundamental techniques of recombinant DNA technology. They recognised the signific ance of their development but were concerned of the effects on humans and the environment of uncontrolled application of the new, powerful technology. Concern about the possible consequences of genetic manipula tion has undoubtedly been the driving force behind the regulations that are now in place in many parts of the world and which are the subject of this book. Safety issues in the biotechnology industry can be categorised under three headings: worker, environmental and consumer (product) safety.

On June 27-28, 2018, the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) convened an international workshop in Amsterdam, the Netherlands, on developing norms for the provision of laboratories in low-resource contexts. The U.S. Department of State's Biosecurity Engagement Program requested that the National Academies organize this workshop to engage an international group of organizations that provide funding for construction, upgrades, and maintenance of biological laboratories in countries without the means to build such labs themselves. Twenty-one people from 19 organizations participated. The intent was to advance the conversation about the identification and application of guiding principles and common norms for use by these organizations in their grants, partnerships, and aid. This publication summarizes the presentations and discussions from the workshop.

On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the United States government launched a one-year deliberative process to address the continuing controversy surrounding so-called "gain-of-function" (GOF) research on respiratory pathogens with pandemic potential. The gain of function controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next three years. The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GOF experiments with influenza, SARS, and MERS viruses that would inform the development and adoption of a new U.S. Government policy governing the funding and conduct of GOF research. Potential Risks and Benefits of Gain-of-Function Research is the summary of a two-day public symposia on GOF research. Convened in December 2014 by the Institute of Medicine and the National Research Council, the main focus of this event was to discuss principles important for, and key considerations in, the design of risk and benefit assessments of GOF research. Participants examined the underlying scientific and technical questions that are the source of current discussion and debate over GOF research involving pathogens with pandemic potential. This report is a record of the presentations and discussion of the meeting.

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.

AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).