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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 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.
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.
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.
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.
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.
Ensuring National Biosecurity: Institutional Biosafety Committees reviews the various responsibilities and associated challenges Institutional Biosafety Committees (IBCs) face and proposes changes that may help improve this system and increase national biosecurity and worker safety. In recent years IBCs in academic and other institutions have been tasked with increasing levels of responsibility, overseeing work with recombinant genetic material and hazardous agents. IBC members often lack the training to effectively ensure that the work performed is truly safe for scientists and the general community, and so increasingly rely upon the expertise of the researchers themselves. With the proposed US dual-use research policies soon to be implemented, this strain may increase. This book provides readers with the necessary information to be able to enhance national biosecurity within the US, EU, Australia, New Zealand, Japan and more. Ensuring National Biosecurity is as an invaluable reference for biosafety professionals or for researchers who need to understand the regulatory landscape that impacts their research. - Examines and assesses the current state of Institutional Biosafety Committees (IBCs) - Collates contributions from world-renowned experts in fields as diverse as research compliance, law and astrobiology - Reflects an international perspective on regulatory biosecurity and biosafety
This volume focuses on Global Catastrophic Biological Risks (GCBRs), a special class of infectious disease outbreaks or pandemics in which the combined capacity of the world’s private and government resources becomes severely strained. These events, of which the 1918 influenza pandemic is emblematic, cause severe disruptions in the normal functioning of the world, exact heavy tolls in terms of morbidity and mortality, and lead to major economic losses. GCBRs can be caused by any type of microorganism, and myriad contextual factors can influence their impact. Additionally, there are cascading questions that arise in connection with GCBR prediction, preparation, and response. This book gathers contributions from thought leaders who discuss the multi-faceted approaches needed in order to address this problem. From understanding the special characteristics of various microbes to financing challenges, the volume provides an essential primer on a neglected but highly relevant topic. Physicians, scientists, policymakers, public health practitioners and anyone with an interest in the field of pandemics, emerging infectious disease, biosecurity, and global health security will find it a valuable and insightful resource.
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.
This is the third edition of this manual which contains updated practical guidance on biosafety techniques in laboratories at all levels. It is organised into nine sections and issues covered include: microbiological risk assessment; lab design and facilities; biosecurity concepts; safety equipment; contingency planning; disinfection and sterilisation; the transport of infectious substances; biosafety and the safe use of recombinant DNA technology; chemical, fire and electrical safety aspects; safety organisation and training programmes; and the safety checklist.