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.

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.

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.

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.

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 ultimate aim of Cleverbio has been to build a normative model that incorporates: