The Biological Threat Reduction Program of the Department of Defense


Book Description

This Congressionally-mandated report identifies areas for further cooperation with Russia and other states of the former Soviet Union under the Cooperative Threat Reduction (CTR) program of the Department of Defense in the specific area of prevention of proliferation of biological weapons. The report reviews relevant U.S. government programs, and particularly the CTR program, and identifies approaches for overcoming obstacles to cooperation and for increasing the long-term impact of the program. It recommends strong support for continuation of the CTR program.




Responsible Research with Biological Select Agents and Toxins


Book Description

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.




Giving Full Measure to Countermeasures


Book Description

In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.




Department of Defense Biological Safety and Security Program


Book Description

DoD is developing defensive capability against biological agents and toxins. This study addresses these themes: Are current and proposed policies in DoD biological safety, security and biological personnel reliability programs adequate to safeguard against accidental or intentional loss/misuse of Biological Select Agents and Toxins (BSAT)? Are current DoD assoc. labs. that use or store BSAT meeting stringent standards for safety, security and personnel reliability? How do DoD programs compare with other gov¿t. agency, academic, and industry programs? How can DoD usefully employ experience in other areas requiring the utmost safety and reliability when handling dangerous material for biosurety policy dev¿t. and implementation?




Applied Biosecurity: Global Health, Biodefense, and Developing Technologies


Book Description

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.




Enhancing Food Safety


Book Description

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.




Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories


Book Description

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.




Laboratory Biorisk Management


Book Description

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.




Science and Security in a Post 9/11 World


Book Description

Based on a series of regional meetings on university campuses with officials from the national security community and academic research institutions, this report identifies specific actions that should be taken to maintain a thriving scientific research environment in an era of heightened security concerns. Actions include maintaining the open exchange of scientific information, fostering a productive environment for international scholars in the U.S., reexamining federal definitions of sensitive but unclassified research, and reviewing policies on deemed export controls. The federal government should establish a standing entity, preferably a Science and Security Commission, that would review policies regarding the exchange of information and the participation of foreign-born scientists and students in research.




Dual Use Research of Concern in the Life Sciences


Book Description

The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.