Biosafety and Biosecurity

• Astuto-Gribble LM, Gaudioso JM, Caskey SA, et al. (2009). A Survey of Bioscience Research and Biosafety and Biosecurity Practices in Asia, Eastern Europe, Latin America, and the Middle East. Applied Biosafety, 14(4), 181-96.
  • In the past decade, the United States has enacted extensive federal legislation to regulate the possession, use, and transfer of dangerous microorganisms and toxins. Yet, few international laboratories have implemented similar safeguards. Limited data are available concerning the types of biological agents researched in non-U.S. laboratories and the biosafety and biosecurity practices employed to maintain those agents. This study reports on a survey that was administered to address these knowledge gaps. Analysis of the data revealed several interesting findings; these findings are summarized into three major themes: biosafety is more prevalent than biosecurity, simple practices and techniques predominate, and perceptions of risk vary regionally.

• Atlas RM, Reppy J. (2005). Globalizing Biosecurity. Biosecurity and Bioterrorism, 3(1), 51-60.
  • A harmonized international regime that enhances biosecurity is needed to reduce the risk of bioterrorism. Like other security regimes, this will entail mutually reinforcing strands, which need to include: enactment of legally binding control of access to dangerous pathogens, transparency for sanctioned biodefense programs, technology transfer and assistance to developing countries to jointly advance biosafety and biosecurity, global awareness of the dual-use dilemma and the potential misuse of science by terrorists, and development of a global ethic of compliance. To work, this effort must be undertaken collectively, utilizing the international and regional institutions that already have a role to play in providing safety and security. Notably, it must grow in a top-down manner from the Biological Weapons Convention accord, in which States Parties have agreed to ban the development of biological weapons, and in a bottom-up manner from the scientific and health communities, which are engaged in the research and public health efforts that must be protected against misuse—especially involving the World Health Organization.

• Berns KI, Casadevall A, Cohen ML, et al. (2012). Adaptations of Avian Flu Virus Are a Cause for Concern. Science, 335 (6069), 660–61.
  • We are in the midst of a revolutionary period in the life sciences – technological capabilities have dramatically expanded, we have a much-improved understanding of the complex biology of selected microorganisms, and we have an increased ability to manipulate microbial genomes. With this has come unprecedented potential for better control of infectious diseases and significant societal benefit. However, there is also a growing risk that the same science will be deliberately misused and that the consequences could be catastrophic. This article discusses potential dual-use and biosecurity implications of publishing on avian influenza experiments in detail.

• Bielecka A, Mohammadi AA. (2014). State-of-the-Art in Biosafety and Biosecurity in European Countries. Archivum immunologiae et therapiae experimentalis, 62(3), 169-78.
  • The terms biosafety and biosecurity are widely used in different concepts and refer not only to protection of human beings and their surrounding environment against a hazardous biological agent, but also to the global disarmament of weapons of mass destruction. As a result, the biosafety and biosecurity issues should be considered interdisciplinary based on multilateral agreements against the proliferation of biological weapons, public health, and environmental protection. This publication presents information on both, international and national biosafety and biosecurity legislation.

• Blaine JW. (2012). Establishing a National Biological Laboratory Safety and Security Monitoring Program. Biosecurity and Bioterrorism, 10 (4), 396-400.

  • The growing concern over the potential use of biological agents as weapons and the continuing work of the Biological Weapons Convention has promoted an interest in establishing national biological laboratory biosafety and biosecurity monitoring programs. The challenges, issues, and key questions that should be considered by governments, or organizations, embarking on the creation of a biological laboratory biosafety and biosecurity monitoring program are discussed in this article.

• Centers for Disease Control and Prevention. (2011). Guidelines for Biosafety and Laboratory Competency. Morbidity and Mortality Weekly Report, 15(60), 1-23.
  • These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels (BSLs) (levels 2, 3, and 4). The competencies are tiered to a worker’s experience at three levels: entry-, mid-, and senior-level. These guidelines were developed on behalf of CDC and the Association of Public Health Laboratories by an expert panel. The guidelines are intended for laboratorians working with hazardous biologic agents, obtained from either samples or specimens that are maintained and manipulated in clinical, environmental, public health, academic, and research laboratories.

• Chosewood LC, Wilson DE. (1999). Biosafety in Microbiological and Biomedical Laboratories, 5ed. HHS Publication No. (CDC) 21-1112. Washington: U.S. Department of Health and Human Services.

  • Biosafety in Microbiological and Biomedical Laboratories quickly became the cornerstone of biosafety practice and policy in the United States upon first publication in 1984. This edition of the BMBL includes additional sections, expanded sections on the principles and practices of biosafety and risk assessment; and revised agent summary statements and appendices. The document is an advisory resource recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective

• Cook DC, Liu S, Murphy B, et al. (2010). Adaptive approaches to biosecurity governance. Risk Analysis, 30(9), 1303-14.
  • This article discusses institutional changes that may facilitate an adaptive approach to biosecurity risk management where governance is viewed as a multidisciplinary, interactive experiment acknowledging uncertainty. Using the principles of adaptive governance, evolved from institutional theory, we explore how the concepts of lateral information flows, incentive alignment, and policy experimentation might shape Australia’s invasive species defense mechanisms. The authors suggest design principles for biosecurity policies emphasizing overlapping complementary response capabilities and the sharing of invasive species risks via a polycentric system of governance.

• Dickmann P, Apfel F, Biedenkopf N, et al. (2015). Marburg Biosafety and Biosecurity Scale (MBBS), A Framework for Risk Assessment and Risk Communication. Health Security, 13(2), 88-95.
  • Current risk assessment and risk communication of biosafety and biosecurity concerns lack a convenient metric and conceptual framework. The absence of such a systematic tool makes communication more difficult and can lead to an ambiguous public perception of and response to laboratory biosafety incidents and biosecurity threats. These authors propose a new 7-category scoring scale is proposed for incidents and situations in laboratories related to the handling of human and animal pathogens. The scale aims to help clarify risk categories, facilitate coordination and communication, and improve public understanding of risk related to biosafety and biosecurity.

• Dickmann P, Sheeley H, Lightfoot N. (2015). Biosafety and biosecurity: a relative risk-based framework for safer, more secure, and sustainable laboratory capacity building. Frontiers in Public Health, 3, 241-47.
  • Laboratory capacity building is characterized by a paradox between endemicity and resources: countries with high endemicity of pathogenic agents often have low and intermittent resources and capacities. Meanwhile, countries with low endemicity of pathogenic agents often have high-containment facilities with costly infrastructure and maintenance governed by regulations. These authors developed a conceptual framework for safer, more secure, and sustainable laboratory capacity building.

• Donaldson A. (2008). Biosecurity after the Event: Risk Politics and Animal Disease. Environmental and Planning. 40(7), 1552-67.
  • This paper examines the politics of agricultural biosecurity in the UK, following the 2001 epidemic of foot and mouth disease. Biosecurity politics epitomize the ‘risk politics’ of animal disease, which acts antipolitically by focusing on problem-solving mechanisms and shutting down spaces for debate and dissent. By following biosecurity through three sites, various inconsistencies of these politics are described.

• Faden RR, Karron RA. (2012). The Obligation to Prevent the Next Dual-Use Controversy. Science, 335(6070), 802-04.
  • For the first time, the U.S. National Science Advisory Board for Biosecurity (NSABB) has recommended that research done by two separate groups be redacted, an unprecedented caution that has unleashed debate over the proper balance of global security, public health, and the integrity of science. Although Science and Nature agreed to redact the research for publication to help prevent the misuse of this science by hostile actors, they made that agreement contingent on the establishment of a mechanism to allow appropriate researchers and public health officials access to the complete information. This article discusses the ethical dimensions behind this decision.

• Fearnley L. (2008). Signals Come and Go: Syndromic Surveillance and Styles of Biosecurity. Environmental and Planning, 40(7), 1615–32.
  • This paper follows the development of a novel biosecurity technology known as ‘syndromic surveillance’. By monitoring new sources of nondiagnostic health information, syndromic surveillance produces new ‘territories of intelligibility’. But the implemention of syndromic systems poses a problem of interpretation. What is significant in nondiagnostic data flows? This article discusses a disjuncture between two interpretative frameworks of governing biosecurity: public health and preparedness.

• Garfinkle M, Knowles L. (2014). Synthetic Biology, Biosecurity, and Biosafety. In: Sandler RL (eds) Ethics and Emerging Technologies. London: Palgrave Macmillan.
  • The primary extrinsic concerns regarding synthetic organisms are to do with their human health and environmental risks. One reason for this is that they are microorganisms that can cause illnesses and ecological disruption. Another reason is the growth of DIY (do-it-yourself) biotech and garage biotechnology. In this chapter, the authors present and evaluate governance strategies – both hard and soft law – for managing the risks associated with synthetic genomics, while also fostering innovation and realizing its potential benefits.

• Gaudioso J, Salerno RM. (2004). Biosecurity and Research: Minimizing Adverse Impacts. Science, 304(5671), 687-90.
  • Because of concerns about bioterrorism and biological weapons, the United States instituted security regulations governing a list of pathogens and toxins. The regulations seem daunting, and this is causing researchers to decide whether or not they want to possess a listed agent. These authors believe a workable balance between security and research can and must be achieved and discuss how that balance could be realized.

• Gaudioso J, Gribble LA, Salerno RM. (2009). Biosecurity: Progress and Challenges. Journal of the Association for Laboratory Automation, 14(3), 141-47.
  • Bioscience facilities are essential to the efforts to combat both naturally occurring infectious diseases and bioterrorism. But both the general public and policymakers are questioning how bioscience institutions address the safety and security risks of handling infectious disease-causing organisms. This paper aims to give readers an overview of the evolving norms for biosafety, and, especially, the dynamic field of biosecurity. The overview provides a foundation for an examination of significant biosecurity challenges that policymakers and bioscience institutions face in the coming years and demonstrates the need for partnerships between the technical and policy communities to address these challenges.

• Gaudioso J, Rivera SB, Caskey S, et al. (2006). Laboratory Biosecurity: A Survey of the U.S. Bioscience Community. Applied Biosafety, 11(3), 138-43.
  • Laboratory biosecurity practices, or measures to prevent the theft or sabotage of biological research materials, must coexist with biosafety. This study reports on a survey administered to assess the extent biosecurity is implemented in laboratories and the relationship between biosecurity and biosafety and good laboratory practices in regulated select and non-select agent laboratories.

• Gostin LO, Phelan A. (2014). The Global Health Security Agenda in an Age of Biosecurity. JAMA, 312(1), 27-28.
  • The United States launched the Global Health Initiative in 2009 with ambitious goals of reforming foreign assistance, expanding programs, and coordinating agencies. Five years later, the White House launched another bold initiative—the Global Health Security Agenda (GHSA), a US-led diplomatic collaboration with 30 countries, international organizations, nongovernmental organizations, and public/private entities. This opinion piece explores if the GHSA’s policy shift toward securitization represents a positive step for global health?

• Gronvall GK. (2014). National-level biosafety norms needed for dual-use research. Frontiers in Public Health, 2, 84–86.
  • Dual-use concerns – that legitimate research has the potential to be misused – are inherent in life sciences research. In the past 15 years, numerous scientific papers have raised security questions, and split opinions of scientists, ethicists, and policymakers on whether the research should have been performed or published. This article discusses the biosafety and biosecurity policies needed given the increasing ease of manipulating and synthesizing genetic material, and the continued expansion of global biological research.

• Gronvall GK, Rozo M. (2015) Addressing the Gap in International Norms for Biosafety Trends in Microbiology. Trends in Microbiology, 23(12), 743-44.

  • There is currently a lack of national-level norms for biosafety. Considering that a laboratory accident involving a contagious pathogen could have long-term consequences that extend beyond an individual incident into the practice of science more broadly, it is in the interests of scientists everywhere that international norms are developed. This article discusses the need for biosafety experts, scientists, and their professional associations to determine what are the reasonable combinations of standard biosafety activities and oversight mechanisms.

• Gronvall GK, Boddie C, Knuttson R, et al. (2014). One Health Security: An Important Component of the Global Health Security Agenda. Biosecurity and Bioterrorism, 12(5), 221-24.
  • The objectives of the Global Health Security Agenda (GHSA) will require not only a One Health approach to counter natural disease threats against humans, animals, and the environment, but also a security focus to counter deliberate threats to human, animal, and agricultural health and to nations’ economies. The authors term this merged approach One Health Security and discuss the requirements of professionals with expertise in security, law enforcement, and intelligence to join the veterinary, agricultural, environmental, and human health experts essential to One Health and the GHSA.

• Hastein T, Binde M, Hine M, et al. (2008). National biosecurity approaches, plans and programmes in response to diseases in farmed aquatic animals: evolution, effectiveness and the way forward. Revue Scientifique Et Technique-Office International Des Epizooties, 27(1), 125-45.
  • The rapid increase in aquaculture production and trade, and increased attention to the negative effects of disease, are becoming stimuli for developing national biosecurity strategies for farmed fisheries, for which the World Organisation for Animal Health (OIE) Aquatic Animal Health Code and Manual of Diagnostic Tests for Aquatic Animals serve as an excellent framework. Using examples from a few countries and selected diseases, this paper provides a general overview of the development of approaches to implementing biosecurity strategies, including those emerging in the national legislation and regulations of some countries, and those being initiated by industries themselves. The determination of disease status in different epidemiological units (from a farm to a nation), appropriate approaches for preventing the introduction of disease and developing contingencies for disease control and eradication are also discussed. Important to the effectiveness of such strategies are the provision of financial, personnel and other resources to implement them, including incentives such as indemnification or compensation in eradication programmes, and practical linkage to regulatory or government policy initiatives.

• Heffernan C, Nielsen L, Thomson K, et al. (2008). An exploration of the drivers to bio-security collective action among a sample of UK cattle and sheep farmers. Preventative Veterinary Medicine, 87(3-4), 358-72.
  • At present, collective action regarding bio-security among UK cattle and sheep farmers is rare. Despite the occurrence of catastrophic livestock diseases such as bovine spongiform encephalopathy (BSE) and foot and mouth disease (FMD), within recent decades, there are few national or local farmer-led animal health schemes. To explore the reasons for this apparent lack of interest, these authors utilize a socio-psychological approach to disaggregate the cognitive, emotive and contextual factors driving bio-security behavior among cattle and sheep farmers in the United Kingdom.

• Homer LC, Alderman TS, Blair HA, et al. (2013). Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories. Biosecurity and Bioterrorism, 11(1), 10-19.
  • The Guidelines for Biosafety Training Programs for Workers Assigned to BSL-3 Research Laboratories were developed by biosafety professionals who oversee training programs for the 2 national biocontainment laboratories (NBLs) and the 13 regional biocontainment laboratories. These guidelines provide a general training framework for biosafety level 3 (BSL-3) high-containment laboratories, identify key training concepts, and outline training methodologies designed to standardize base knowledge, understanding, and technical competence of laboratory personnel working in high-containment laboratories. These guidelines may be of value to other institutions and academic research laboratories that are developing biosafety training programs for BSL-3 research.

• Jin Y, McCarl B, Elbakidze L. (2009). Risk assessment and management of animal disease-related biosecurity. International Journal of Risk Assessment and Management, 12(2-4), 186-203.
  • Animal agriculture is vulnerable to both intentional and unintentional biological threats. Outbreaks, especially intentional attacks, could cause enormous consequences extending well beyond agriculture. This article presents a literature review discussing vulnerability and mitigation strategies and issues of relevance to agricultural security and then presents strategic recommendations based on economic analyses. These recommendations address (i) what categories of mitigation strategies are likely to be most effective, (ii) what implementation obstacles exist and how these implementation challenges could be managed or overcome, and (iii) what leverages can be done on technology, scientific advancement and education.

• Jonsson CB, Cole KS, Roy CJ, et al. (2013). Challenges and Practices in Building and Implementing Biosafety and Biosecurity Programs to Enable Basic and Translational Research with Select Agents. Journal of Bioterrorism & Biodefense, 3(15), 12634-53.

  • Select agent research in the United States must meet federally-mandated biological guidelines and rules which are comprised of two main components: biosecurity and biosafety. Biosecurity is the process employed for ensuring biological agents are properly safeguarded against theft, loss, diversion, unauthorized access or use/release. Biosafety is those processes that ensure that operations with such agents are conducted in a safe, secure and reliable manner. This article discusses the requirements and the various activities that the laboratory programs have implemented to achieve metrics set forth by various agencies within the U.S. Federal government.

• Kelle A. (2009). Synthetic biology and biosecurity. EMBO Reports, 10(1S), S23-27.
  • Synthetic biology has become one of the most dynamic research fields in the life sciences. In reality, though, the term is used to cover a host of different approaches rather than a single defined discipline; these range from the large‐scale assembly of DNA segments to the development of new tools and technology platforms, and to the search for the minimal cell and the origins of life. The evolution of the field has also been accompanied by the recognition that the concomitant shift in biology from a descriptive to a predictive science, and the technologies that will ensue, bring with them a range of potential societal implications and dangers. This article discusses the biosecurity implications of synthetic biology,

• Kennedy SB, Wasunna CL, Dogba JB, et al. (2016). The laboratory health system and its response to the Ebola virus disease outbreak in Liberia. African Journal of Laboratory Medicine, 5(3), 1-5.
  • This article briefly describes the pre-Ebola virus disease (EVD) laboratory capability in Liberia. The authors then extensively explore the post-2014 EVD strengthening initiatives to enhance capacity, mobilize resources and coordinate disaster response with international partners to rebuild the laboratory infrastructure in the country – all efforts to directly or indirectly improve national biosafety and biosecurity.

• Koblentz GD. (2010). Biosecurity Reconsidered: Calibrating Biological Threats and Responses. International Security, 34(4), 96-132.
  • Advances in science and technology, the rise of globalization, the emergence of new diseases, and the changing nature of conflict have increased the risks posed by naturally occurring and man-made biological threats. A growing acceptance of a broader definition of security since the end of the Cold War has facilitated the rise of biosecurity issues on the international security agenda. This paper advocates for a taxonomy of biological threats based on a levels-of-analysis approach that identifies which types of actors are potential sources of biological threats and the groups most at risk from these threats. A biosecurity taxonomy can provide a common framework for the multidisciplinary research and analysis necessary to assess and manage these risks. It also has implications for how to prevent and respond to biological threats, as well as for the future of biosecurity research.

• Kruger H, Thompson L, Clarke R, et al. (2010). Engaging in Biosecurity. Canberra:  Commonwealth of Australia.
  • Risks to Australia’s biosecurity are increasing as the mobility of people, plants, animals and trade increases within Australia and across international borders. The purpose of this document is to review the current activities, approaches, and relationships between government, industry representatives and community, including landholders, relevant to Australian biosecurity engagement.

• Kuhlau F, Eriksson S, Evers K, et al. (2008). Taking Due Care: Moral Obligations in Dual Use Research. Bioethics, 22(9), 477-87.
  • In the past decade, the perception of a bioterrorist threat has increased and created a demand on life scientists to consider the potential security implications of dual-use research. This article examines a selection of proposed moral obligations for life scientists that have emerged to meet these concerns and the extent to which they can be considered reasonable. It also describes the underlying reasons for the concerns, how they are managed, and their implications for scientific values.

• Kwik G, Fitzgerald J, Inglesby TV, et al. (2003). Biosecurity: Responsible Stewardship of Bioscience in an Age of Catastrophic Terrorism. Biosecurity and Bioterrorism, 1(1), 27-35.

  • Biological research has undergone tremendous growth and transformation. This expansion of knowledge and the powers it brings shows no signs of slowing, and will undoubtedly bring vast benefits in diagnosing, preventing, and curing disease, and in improving agriculture. However, a plentiful array of the same tools, techniques, and knowledge that have beneficent uses could, if misapplied, be used to destroy human life or agriculture on a mass scale. This article discusses regulations, incentives, cultural expectations and practices that encourage and enable scientific progress.

• Lipsitch M, Plotkin JB, Simonsen L, et al. (2012). Evolution, Safety, and Highly Pathogenic Influenza Viruses. Science, 336(6088), 1529-31.
  • Experience with influenza has shown that predictions of virus phenotype or fitness from nucleotide sequences are imperfect and that predicting the timing and course of evolution is extremely difficult. Such uncertainty means that the risk of experiments with mammalian-transmissible, possibly highly virulent influenza viruses remains high even if some aspects of their laboratory biology are reassuring; it also implies limitations on the ability of laboratory observations to guide interpretation of surveillance of strains in the field. These authors propose that future experiments with virulent pathogens whose release could lead to the extensive spread in human populations should be limited by explicit risk-benefit considerations.

• Litaay T. (2011). Policy and Legal Framework for Managing Biosecurity. In: Falk I, Wallace R, Ndoen M. (eds) Managing Biosecurity Across Borders. Dordrecht: Springer.
  • Advancements in transport technologies have increased the movement of people and goods from one region to another. This movement brings along with it positive outcomes, such as trading in or sharing goods, information and services, but also negative outcomes such as the introduction of pests and diseases. The latter designates the focus of this chapter, which is on the policy and legal frameworks in which biosecurity currently rests.

• McLeish C, Nightingale P. (2007). Biosecurity, bioterrorism and the governance of science: The increasing convergence of science and security policy. Research Policy, 36(10), 1635-54.
  • Science and security policy are increasingly overlapping because of concerns that legitimate research might be misapplied to develop biological weapons. This has led to an expansion of security policy to cover broad areas of research and scientific practice, including funding, publishing, peer-review, employment, materials transfer, post-graduate teaching and academics’ ability to design and perform experiments and disseminate research. This paper explores recent changes in the governance of science and technology and contributes to future policymaking by assessing the relative merits of understanding the development of dual-use policy in terms of either technology transfer or technology convergence.

• Meyerson LA, Reaser JK. (2003). Bioinvasions, bioterrorism, and biosecurity. Frontiers in Ecology and the Environment, 1(6), 307-14.
  • Despite their high profile and potentially devastating consequences, bioterrorist acts are relatively unpredictable, rare, and thus far small-scale events. In contrast, biological invasions are occurring daily in the US and have significant impacts on human health, agriculture, infrastructure, and the environment, yet they receive far less attention and fewer resources. This paper argues for collaborations between scientists and governments to implement a comprehensive approach to biosecurity that addresses not only bioterrorism, but also the more common incursions of invasive alien species. This approach should also address the potential for the deliberate use of invasive alien species as agents of bioterrorism.

• Meyerson LA, Reaser JK. (2002). Biosecurity: Moving toward a Comprehensive Approach. Bioscience. 52(7), 593–600.
  • The purpose of this article is to illustrate the need for the governments to adopt a comprehensive biosecurity approach to minimize the risk of harm caused by foreign (nonnative) organisms to the economy, the environment, and human health.

• Nisii C, Castilletti C, Di Caro A, et al. (2009). The European network of Biosafety-Level-4 laboratories: enhancing European preparedness for new health threats. Clinical Microbiology and Infection, 15(8), 720-26.
  • Established in 2005, the European Community (EC)-funded European Network of Biosafety-Level-4 laboratories (Euronet-P4)  brings together the laboratories in Porton Down, London, Hamburg, Marburg, Solna, Lyon and Rome to increase international collaboration in the areas of high containment laboratory biosafety and viral diagnostic capability, to strengthen Europe’s capacity to respond to an infectious disease emergency, and to offer assistance to countries not equipped with such costly facilities. This paper describes the current state of and future prospects for the Euronet-P4.

• Nordmann BD. (2010). Issues in biosecurity and biosafety. International Journal of Antimicrobial Agents, 36, S66-69.
  • The role of non-governmental organizations and other interested observers has long been neglected by governments in the quest for a world secure from the threat of biological weapons or bioterrorism. New trends illustrate a greater appreciation of a strong need for a cooperative partnership. Governments need to accept and embrace some of these new trends and new technologies. This paper attempts to present an overview of selected issues in the biosecurity dialogue.

• Pritt S, Hankenson FC, Wagner T, et al. (2007). The basics of animal biosafety and biocontainment training. Lab Animal, 36(6), 31-39.
  • The threat of biocontamination in an animal facility is best subdued by training. ‘Training’ is an ambiguous designation that may not be adequately appreciated in all animal facilities. These authors propose concrete training topics and provide practical advice on incorporating the basic principles of facility biosafety training—as well as the precautions and procedures that employees must know in case of accident or emergency—into various training models. They also discuss the current biosafety publications and guidelines and their relationship to biosafety training.

• Rao JE. (2011). United States Department of State’s Biosecurity Engagement Program: Bio Threat Reduction Through International Partnerships. In: Pilch RF, Zilinskas RA (eds). Encyclopedia of Bioterrorism Defense. Hoboken: John Wiley & Sons, Inc.
  • The rise of transnational terrorist networks, emerging infectious diseases and rapid growth of bioscience capacities around the globe have dramatically changed the landscape of biological threats to the United States, and the world. This chapter describes the Biosecurity Engagement Program (BEP), which was launched to help meet these threats and to extend the spirit of Nunn-Lugar partnership toward combating emerging biological threats.

• Richmond JY, Nesby-ODell SL. (2003). Biosecurity for Animal Facilities and Associated Laboratories. Lab Animal, 32(1), 32-35.
  • Although working with human pathogens and zoonotic agents has always carried a certain degree of danger, current events have resulted in an increased focus on the subject, including new regulations. This paper discusses several of risk assessment and management activities that animal research facilities can use to evaluate and strengthen their current programs.

• Shahi GS, Nadershahi AH. (2009). Method and system for assessing and managing biosafety and biosecurity risks. U.S. Patent Application No. 12/038,643.
  • These methods and systems establish biosafety and biosecurity risk management procedures and systems, and facilitate auditing of facilities and testing individuals and companies to evaluate compliance with such procedures and systems. Systems and business methods for establishing procedures and systems, auditing and certifying companies, facilities, systems and individuals for compliance, and analyzing biosafety and biosecurity risks for making investment decisions and for pricing and underwriting such risks in the insurance industry.

• Shea DA. (2006). Oversight of Dual-Use Biological Research: The National Science Advisory Board for Biosecurity. CRS Report for Congress. Washington: Congressional Research Service.
  • Policymakers have addressed the threat of biological weapons and biosecurity issues for many years. An issue garnering increased attention is the potential for life sciences research intended to enhance scientific understanding and public health to generate results that could be misused to advance biological weapon effectiveness. Such research has been called dual-use research because of its applicability to both biological countermeasures and biological weapons. This report was prepared for the Congress of the United States to inform on the current state of dual-use governance.

• Sture J, Whitby S, Perkins D. (2013). Biosafety, biosecurity and internationally mandated regulatory regimes: compliance mechanisms for education and global health security. Medicine, Conflict and Survival, 29(4), 289-321.
  • This paper highlights the biosafety and biosecurity training obligations that three international regulatory regimes place upon states parties. The duty to report upon the existence of such provisions as evidence of compliance is discussed in relation to each regime. The authors argue that such mechanisms can be regarded as building blocks for the development and delivery of complementary biosafety and biosecurity teaching and training materials.

• Tucker JB. (2009). Strategies to Prevent Bioterrorism: Biosecurity Policies in the United States and Germany. In: Rappert B, Gould C. (eds) Biosecurity. New Security Challenges Series. London: Palgrave Macmillan.
  • The mailing of letters contaminated with anthrax spores through the US postal system in September–October 2001 resulted in the infection of 22 people, five of whom died, and caused expanding ripples of fear, social disruption, and economic damage. This crime called attention to the need for ‘biosecurity’ measures to prevent terrorists from acquiring the materials and know-how required to carry out biological attacks. This chapter discusses measures to limit the threat of dual-use technology and improve biosecurity.

• Tucker JB. (2003). Preventing the misuse of pathogens: The need for global biosecurity standards. Arms Control Today, 33(5), 1-12.

  • Efforts to counter bioterrorism have focused on the medical and public health response to an attack rather than on prevention. Although improved disease surveillance and therapeutic countermeasures are needed, it is also critical to impede biological attacks by making it more difficult for terrorists to obtain deadly pathogens and toxins. This author advocates for new global biosecurity standards to address this gap.

• Van Aken J. (2006). When risk outweighs benefit: Dual-use research needs a scientifically sound risk–benefit analysis and legally binding biosecurity measures. EMBO Reports, 7, S10–13.
  • In 2005, a team of US scientists published the full sequence of the highly virulent strain of influenza virus that caused the Spanish influenza pandemic in the winter of 1918–1919 and killed up to 50 million people worldwide. Further work based on the sequence led to the synthesis of an influenza strain containing all eight gene segments from the 1918 pandemic virus, which showed a high virulence and mortality rate when tested in mice. This article discusses the need for ethical and biosecurity considerations regarding this and similar research.

• Wolinetz CD. (2012). Implementing the New U.S. Dual-Use Policy. Science, 336(6088), 1525–27.
  • After a decade of intensive policy discussions on the topic of dual-use research of concern (DURC) in the life sciences, there has been a lack of consensus on how to practically define DURC; whether it is feasible to identify and regulate DURC experiments; how to address the risks associated with DURC; and how to balance this risk with the necessity of fostering life sciences research for public health and biodefense. This article seeks to provide answers to these critical questions.

• World Health Organization. (2004). Laboratory Biosafety Manual: Third Edition. Geneva: World Health Organization.
  • Since it was first published in 1983, the Laboratory Biosafety Manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. This edition has been edited to now cover risk assessment and safe use of recombinant DNA technology, and provides guidelines for the comissioning and cetification of laboratories. Laboratory biosecurity concepts are introduced, and the latest regulations for the transport of infectious substances are reflected. Materials on safety in health-care laboratories, previously published elsewhere by WHO, has also been incorporated.

• World Health Organization. (2006). Biorisk Management: Laboratory Biosecurity Guidance. Geneva: World Health Organization.
  • The Laboratory biosafety manual (LBM3), first published in 2004, has provided guidance to laboratory workers on how to perform laboratory work safely, to laboratory managers on how to set up a managerial approach to biosafety and to regulatory authorities, to help them consider necessary aspects for the development of adequate national biosafety regulations. This edition of the document aims to expand the laboratory biosecurity concepts introduced in LBM3, and to strike a balance between the long-known biosafety procedures and practices described in LBM3 and the more recently introduced and broader biosecurity concepts.

• World Health Organization. (2012). Laboratory Biorisk Management: Strategic Framework for Action 2012-2016. Geneva: World Health Organization.
  • At present there is no overarching framework or global strategy in this area to provide strategic direction to ensure that investments are planned and implemented appropriately to meet these needs. Without such strategic planning, biorisk management runs the danger of failing to meet the objective of delivering solutions that allow countries to build stand-alone capacity and capability. This plan sets out a basis and rationale for WHO’s role in supporting the measures and mechanisms required to move towards the objective of supporting safe and secure environments in and around every laboratory in the world.

• World Health Organization. (2013). Guidance on Regulations for the Transport of Infectious Substances 2013-2014. Geneva: World Health Organization.
  • In order to make appropriate decisions, shippers must understand their need and obligation to be familiar with regulatory requirements. Dangerous goods regulations require all personnel involved in transport to undergo appropriate training. Appropriate training and education, commensurate with the shipper’s responsibilities, will provide the shipper with the necessary degree of familiarity with applicable requirements, addressing identification, classification, packaging, marking, labelling, refrigeration and required documentation for the transport of infectious substances. This document will familiarize the reader with current international and modal requirements for the shipment of infectious substances.

• Zaki AN. (2010). Biosafety and biosecurity measures: management of biosafety level 3 facilities. International Journal of Antimicrobial Agents, 36, S70-74.
  • With the increasing biological threat from emerging infectious diseases and bioterrorism, it has become essential for governments around the globe to increase awareness and preparedness for identifying and containing those agents. This article introduces the basic concepts of laboratory management, laboratory biosafety and laboratory biosecurity.