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Issues in Biosecurity and Biosafety


Article
Brian Nordmann
Director, Bureau of Arms Control, Verification and Compliance, Office of Verification and Transparency Technologies
Article featured in the International Journal of Antimicrobial Agents
Washington, DC
November 1, 2010

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Abstract

The role of non-governmental organisations and other interested observers – civil society – 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. At least since 2001 and the Amerithrax anthrax letters, the USA has had a significant focus on biosecurity and the related subject of biosafety. Biosecurity has also been raised to a place of prominence in security discussions throughout much of the rest of the globe, largely through the mechanisms of the Biological and Toxin Weapons Convention and related groups, but also through the World Health Organization and the implementation of the International Health Regulations, which is scheduled for 2012. Despite this attention, a clear understanding of the meanings of biosecurity and biosafety has yet to be achieved. Partly because of this lack of definition, and largely because of a broader understanding of the capabilities of the life sciences, many topics have begun to fall under the heading of biosecurity. This paper will not be able to explore all of these new topics but will instead attempt to present an overview of some of the issues at play today in the biosecurity dialogue.

1. One World, One Health

US President Barack Obama, speaking on his Global Health Initiative in May 2009 [1], said:

We cannot wall ourselves off from the world and hope for the best, nor ignore the public health challenges beyond our borders…we cannot simply confront individual preventable illnesses in isolation. The world is interconnected, and that demands an integrated approach to global health.

Governments are slowly beginning to understand and embrace the concept of ‘One World, One Health.’ Of the 1461 diseases now recognised in humans, it is estimated that a full 60% are caused by multihost pathogens that affect several species [2]. The seemingly obvious fact that everything on earth is related, and that which affects one affects all – humans, animals, plants – has not yet been fully accepted, but is slowly being understood. As the One Health Commission has pointed out, ‘the convergence of people, animals, and our environment has created a new dynamic in which the health of each group is inextricably interconnected. The challenges associated with this dynamic are demanding, profound, and unprecedented’ [2].

Infectious disease has had a significant effect on civilisation and nations throughout history. Zinsser described that impact in 1935 [3]:

We are dealing with a phase of man's history on earth which has received too little attention from poets, artists, and historians. Swords and lances, arrows, machine guns, and even high explosive have had far less power over the fates of nations than the typhus louse, the plague flea, and the yellow fever mosquito. Civilizations have retreated from the plasmodium of malaria, and armies have crumbled into rubbles under the onslaught of cholera spirilla, or of dysentery and typhoid bacilli. Huge areas have been devastated by the trypanosome that travels on the wings of the tsetse fly, and generations have been harassed by the syphilis of a courtier. War and conquest and that hard existence which is an accompaniment of what we call civilization have merely set the stage for these more powerful agents of human tragedy.

Unfortunately, as these new concepts are coming to the fore, other concepts such as biosecurity and biosafety are becoming lost as little more than buzzwords or semiotic tools, even whilst the ideas behind the words still have not gained consistent currency in the dialogue of the day.

Whilst the science has evolved and continues to evolve, to the ordinary person there is little philosophically different between the notion of phlogiston and today's concepts of nanotechnology or synthetic genomics. Consequently, the dialogue must remain at a level where the average layperson will be able to understand and respond to security needs and requirements.

This is (or at least should be) a policy imperative at all levels of government, both internationally and domestically – federal, state and local. The traditional divisions of private and public sectors no longer stand. Even concepts of national sovereignty are challenged by the rise of globalisation and multilateralism [4]. Paradoxically, as the world becomes smaller and more intertwined and complex, the role of the individual life scientist becomes more critical, and transparency of actions becomes more essential.

Perhaps even more critical than globalisation is the urbanisation of the world's populations. The move to the cities has a number of factors critical to public and global health. First, more people living closer together, often at or below poverty levels in meagre (at best) living conditions, is a powder keg of potential disease reservoirs waiting to explode. Similarly, the destruction of natural forests and wetlands has created a migration of wildlife and its disease vectors closer to a largely unprotected human population. Finally, the ease and routine nature of international air travel makes a disease appearing in a totally unexpected location a greater international health concern. The old saw: ‘All politics is local’ also applies to health. One World, One Health is not just a slogan; it is a fact of life.

The Institute of Medicine's Committee on the US Commitment to Global Health published its Recommendations for the Public and Private Sectors in 2009 [5]. The committee identified five areas for action by the US global health enterprise. These were: (1) scale up existing interventions to achieve significant health gains, (2) generate and share knowledge to address health problems endemic to the global poor, (3) invest in people, institutions and capacity building with global partners, (4) increase US financial commitments to global health, (5) set the example of engaging in respectful partnerships.

Complicating any focussed global health capacity building by the USA is the bureaucratic hodgepodge that reflects the government's efforts in biosecurity today. Over two dozen agencies would have a role if a bioterrorist attack occurred in the USA [6]. The Obama administration named Gary Samore as its White House WMD Coordinator for the prevention of weapons of mass destruction, proliferation, and terrorism – WMD ‘Czar’ – to help address some of this bureaucracy [7].

2. In search of a definition of biosecurity and biosafety

Biosecurity is a term whose definition has no broad acceptance in the international community. In the USA, for example, the term originally described efforts to prevent infectious disease in crops and livestock [9], particularly poultry. As such it included measures ‘that can or should be taken to keep disease (viruses, bacteria, fungi, protozoa, parasites), from a farm and to prevent the transmission of disease (by humans, insects, rodents, and wild birds/animals) within an infected farm to neighboring farms’ [10].

That is clearly an unacceptable definition for responding to the threat of human infectious disease, whether of natural, accidental or deliberate transmission. In general, biosecurity now has a considerably different definition and means ‘active methods to avert biological terrorism or other disease breakouts’ [11].

Understanding of the meaning of biosafety is only a little better. The American Biological Safety Association attempts a definition by explaining what biosafety encompasses. Thus, biosafety includes ‘containment principles, facility design, practices and procedures to prevent occupational infections in the biomedical environment or release of the organisms to the environment’ [12]. Perhaps a more comprehensible definition is that used by the University of Illinois extension programme for livestock biocontainment: ‘keeping the bad bugs from leaving the farm’ [13].

In other countries, however, the concept of biosafety is enmeshed with the concept of biosecurity and a single word is used for a much broader and less specific definition than in the USA. In Germany, for example, the word for both concepts is bioversicherung; in Spanish-speaking countries the word is bioseguridad. It is, of course, important to understand the degree of granularity being used by the speaker in all forms of communication. Complications in understanding are multiplied when the subject is national or international security.

As we have begun to see the world in terms of a multipolar, multithreat environment, the perception of the biosecurity threat and how to respond to it has also changed. Biorisk and matrices to measure the weighted value of each risk have become the norm, and biosecurity and biosafety have come to encompass the use of proper safety measures and facility specifications, as well as the proper training of employees to ensure not only their own safety but that of the public at large.

3. World at risk

In 2008, US Senators Bob Graham and Jim Talent chaired a committee, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. The commission was asked to assess ‘any and all of the nation's activities, initiatives, and programs to prevent weapons of mass destruction, proliferation and terrorism’ and to provide a roadmap to address the threats. The result of their study was the publication World at risk. The commission interviewed over 250 experts from the US government, military, intelligence and political communities, as well as other experts and counterparts in the USA and other countries [14]. A significant part of the study was devoted to the question of biosecurity and bioterrorism.

The commission's sanguine conclusion was that it was ‘more likely than not’ [15] that a terrorist attack using WMD (nuclear, chemical or biological) would occur somewhere in the world by the end of 2013. The group also concluded that terrorists were more likely to obtain and use a biological weapon than a nuclear weapon. This was based on three facts [16]:

First, developing and dispersing a biological weapon would not be expensive – and it will only get cheaper and easier. Second, the lethality of an effectively dispersed biological weapon could rival or exceed that of an improvised nuclear device. Third, the constraints that a bioterrorist would confront in making an effective bioweapon are significantly fewer than those facing nuclear terrorists. Virtually all pathogens suitable for use in a biological weapon are readily available in nature. The equipment required to produce large quantity from a small seed stock, and then ‘weaponize’ the material – that is, to make it into a form that could be effectively dispersed – are of a dual-use nature and are readily available on the internet. The most effective delivery methods are well known in the pharmaceutical, agricultural, and insect-control industries.

The first recommendation in the report clearly stated:

The United States should undertake a series of mutually reinforcing domestic measures to prevent bioterrorism: 1) conduct a comprehensive review of the domestic program to secure dangerous pathogens, 2) develop a national strategy for advancing bioforensic capabilities, 3) tighten government oversight of high-containment laboratories, 4) promote a culture of security awareness in the life sciences community, and 5) enhance the nation's capabilities for rapid response to prevent biological attacks from inflicting mass casualties [16].

The second recommendation followed the same theme, only now focussing on the international scene:

The United States should undertake a series of mutually reinforcing measures at the international level to prevent biological weapons proliferation and terrorism: 1) press for an international conference of countries with major biotechnology industries to promote biosecurity, 2) conduct a global assessment of biosecurity risks, 3) strengthen global disease surveillance networks, and 4) propose a new action plan for achieving universal adherence to and effective national implementation of the Biological Weapons Convention, for adoption at the next review conference in 2011.

In September 2009 legislation was introduced in Congress by Senators Joe Lieberman and Susan Collins to implement the commission's recommendations, in the guise of The Weapons of Mass Destruction (WMD) Prevention and Preparedness Act of 2009 (S. 1649) [17].

4. The role of the scientist

As the perception of the threat has evolved, so too has the perception of the best way to address it. The threat of terrorists acquiring and using pathogens has become the new paradigm. But few, if any, terrorist leaders have a background in molecular biology or epidemiology. Consequently, the concern is that well-funded terrorist groups may seek to use politicised life scientists or hire otherwise disaffected scientists to create a biological agent for use against the USA or others.

As one response to that concern the field of bioethics has taken a leap to the forefront. Bioethics has been defined as encompassing the debate surrounding the social, cultural, legal and ethical implications of the new breakthroughs in the life sciences that are giving human beings ‘new power to improve our health and control the development processes of all living species’ [18].

It is theorised that if scientists were educated within a culture of responsibility then concern about their joining the terrorists might be attenuated, if not eliminated. This rapidly becomes a philosophical conundrum regarding whether there is a universal morality to which all can subscribe. There are largely two camps in this debate: one believes that despite significant cultural differences there remains a core morality held by most, if not all, human communities. The second group argues that local narratives, the heterogeneity of cultures, and incommensurable moral worlds allow communities to reach radically different understandings of acceptable moral practice [19]. That dichotomy aside, there is strong evidence of groups exploring the bioethics issue from different perspectives. In Libya, for example, there is the First Libyan Pioneers Ethics Awareness Group, which has established a presence on Google Groups. Their intended aim is to develop and construct a new strategic approach to practising medical ethics in daily life as well as during work, and developing a core curriculum to apply from that concept. ‘In other words it means doing the right thing’ [emphasis added].

In 2005, at the 33rd session of the General Conference of the United Nations Educational, Scientific and Cultural Organization (UNESCO), the Universal Declaration on Bioethics and Human Rights was unanimously adopted. The declaration aims to promote the establishment of universal ethical principles for the development and application of new scientific and technological advances, particularly where they will affect humans. Its core principle is that ‘human dignity, human rights and fundamental freedoms are to be fully respected.’ The declaration also includes provisions regarding prior informed consent, confidentiality, non-discrimination, international cooperation and benefit sharing [20].

In order to better understand the new threat environment and to help frame the response to it, the US Department of Health and Human Services established the National Science Advisory Board for Biosecurity (NSABB) in 2006. The board was established to ‘provide advice and guidance to the federal government regarding biological research yielding information and technologies with the potential to be misused to pose a biologic threat to public health or national security’ [21]. The NSABB is charged specifically with guiding the development of: (1) a system of institutional and federal research reviews that allows the fulfilment of important research objectives whilst addressing national security concerns, (2) guidelines for the identification and conduct of research that may require special attention and security surveillance, (3) professional codes of conduct for scientists and laboratory workers that can be adopted by professional organisations and institutions engaged in life science research, (4) materials and resources to educate the research community about effective biosecurity and (5) strategies for fostering international collaboration on the effective oversight of dual-use biological research [22].

The establishment of the NSABB was preceded by a critical report from the National Research Council of the National Academies: Biotechnology research in an age of terrorism: confronting the dual-use dilemma [23], more commonly known as the Fink Report after the committee chair, Gerald Fink. The group succinctly summarised the problem with dual-use research:

The great achievements of molecular biology and genetics over the last 50 years have produced advances in agriculture and industrial process and have revolutionized the practice of medicine. The very technologies that fueled these benefits to society, however, pose a potential risk as well – the possibility that these technologies could also be used to create the next generation of biological weapons.

The Fink Report also identified what it considered to be ‘experiments of concern’, or what are colloquially known as ‘the Seven Deadly Sins’: (1) demonstrating how to render a vaccine ineffective, (2) conferring resistance to therapeutically useful antibiotics or antiviral agents, (3) enhancing the virulence of a pathogen or rendering a non-pathogen virulent, (4) increasing transmissibility of a pathogen, (5) altering the host range of a pathogen, (6) enabling the evasion of diagnostic/detection modalities or (7) enabling the weaponisation of a biological agent or toxin.

A review by researchers at the University of Maryland identified 2500 researchers at 300 institutions who were doing research that would have qualified as experiments of concern between 2001 and mid 2005 [24].

In 2007 the NSABB released its framework for the oversight of dual-use research [25]. The framework identified seven key features of the system: (1) federal guidelines, (2) awareness, (3) ongoing mandatory education, (4) evaluation and review of research for dual-use potential, (5) risk assessment and risk management, (6) periodic evaluation and (7) compliance.

Significantly, despite the top-down appearance of the framework's features, the NSABB believed the process of review began not with the government but with the individual principal investigator. This is as it should be. The responsible principal investigator understands the science, knows the people working in the laboratory and is in the best position to define proper, and improper, conduct and procedures. As was posited earlier, it seems paradoxical that as the world becomes more complicated the role of the individual rises in both stature and importance. How does the individual researcher balance this growth in status with responsibility to both science and biosecurity?

It may be as simple as the solution proposed by Hannah Arendt whilst discussing the war crimes trial of Joseph Eichmann and ‘the banality of evil’. Arendt believed Eichmann's evil came not from premeditated posturing or as a response to the interaction of the individual and the political institutions surrounding him but from a lack of consideration of the ramifications of his actions or, as Arendt called it, his thoughtlessness [26]. Therefore, what Arendt proposed as a solution ‘is very simple: it is nothing more than to think what we are doing’ [27].

Because we have moved into an era of One World, One Health we know that biosecurity and biosafety is not an issue that can be addressed by only some researchers but not others, or in some countries but not others. Similarly, One World, One Health does not mean each person is an individual who must go it alone. Collaborations that will allow all laboratories to be safer and more secure are critical to make the world biosafe and biosecure.

It is exactly for this reason that the Biosecurity Engagement Program (BEP) at the US Department of State was created in 2006. Last year alone, the BEP program spent over US$28 million in countries around the world to make sure laboratory facilities were safe and their employees were well trained in good practice.

Past BEP efforts have involved providing technical consultation and risk assessments, and the development of long-term sustainability and management plans to help safeguard and secure biological laboratories in several countries throughout the Middle East, as well as in Africa, the former Soviet Union, and countries in both South and Southeast Asia. BEP has also helped to launch biosecurity associations to bring scientists together to discuss these issues, like the Egyptian Biosafety Association, launched in Cairo in May 2009. Furthermore, BEP seeks to enhance global health security and foster safe, secure, sustainable bioscience capacity development through joint scientific work, prevention, detection and response to biological threats, and capacity building, to help scientists come together to think more deeply about these ideas and share best practices.

References

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[2]. One Health Commission. One Health – World Health Through Collaboration. http://www.onehealthcommission.org/ [accessed 19 April 2010].

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[4]. Fidler DP. Globalization, international law, and emerging infectious diseases. Emerg Infect Dis. 1996;2:77–84. MEDLINE

[5]. Committee on the US Commitment to Global Health . The US commitment to global health: recommendations for the public and private sectors. Washington, DC: The National Academies Press; 2009;.

[6]. Lockwood JA. Six-legged Soldiers: Using Insects as Weapons of War. Oxford: Oxford University Press; 2009;.

[7]. Rozen L. Gary Samore, WMD Czar. Foreign Policy; 23 January 2009.

[9]. Meyerson LA, Reaser JK. Biosecurity: moving toward a comprehensive approach. Bioscience. 2002;52:593–600. CrossRef

[10]. Hegngi FH. Overview of biosecurity and avian influenza. CDC/NIOSH/OSHA/USDA/Industry AI Symposium, 3 November 2004. http://www.cdc.gov/flu/pp/biosecurity_on_farm_11_2004.pdf [accessed 15 May 2010].

[11]. Matishak M. White House, scientists discuss biological threats, global security. Newswire; 28 August 2009.

[12]. American Biological Safety Association. Membership flyer; 2008.

[13]. Wallace D. ‘Biosecurity’ and ‘biocontainment’ for livestock in 2001. University of Illinois; 2001. http://urbanext.illinois.edu/agupdate/0111_article1.html [accessed 19 April 2010].

[14]. Allison G. World at risk: the report of the commission on the prevention of weapons of mass destruction proliferation and terrorism. Testimony, House Armed Services Committee; 22 January 2009.

[15]. Graham B, Talent J. World at risk: the report of the commission on the prevention of WMD proliferation and terrorism. New York: Vintage Books; 2008;.

[16]. Graham B, Talent J. World at risk: The Weapons of Mass Destruction Prevention and Preparedness Act of 2009. Statement, Senate Homeland Security and Governmental Affairs Committee; 22 September 2009.

[17]. Lieberman, Collins seek to protect US against biological and other terrorist attacks. Senate Committee on Homeland Security and Governmental Affairs news release; 8 September 2009. http://hsgac.senate.gov/public/index.cfm?FuseAction=Press.MajorityNews&ContentRecord_id=9ad52357-5056-8059-76f5-42cfed209956 [accessed 15 May 2010].

[18]. UNESCO. Social and human sciences. Food for thought, thought for action. Bioethics. http://portal.unesco.org/shs/en/ev.php-URL_ID=1372&URL_DO=DO_TOPIC&URL_SECTION=201.html [accessed 16 April 2010].

[19]. Turner L. An anthropological exploration of contemporary bioethics: the varieties of common sense. J Med Ethics. 1998;24:127–133. MEDLINE | CrossRef

[20]. UNESCO. Universal Declaration on Bioethics and Human Rights. Information sheet; 2006.

[21]. National Institutes of Health. National Science Advisory Board for Biosecurity. Frequently asked questions. http://oba.od.nih.gov/biosecurity/nsabb_faq.html [accessed 15 May 2010].

[22]. National Institutes of Health. National Science Advisory Board for Biosecurity. About NSABB. http://oba.od.nih.gov/biosecurity/about_nsabb.html [accessed 15 May 2010].

[23]. Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology . Biotechnology research in an age of terrorism: confronting the dual-use dilemma. Washington: National Research Council of the National Academies; 2003;.

[24]. Maurer SM, Cook-Deegan RM, Davidson M, Harris ED, Vangsnes NM, Steinbruner J, et al. A worldwide ‘experiments of concern’ resource portal: concept, plan, and development trajectory. http://gspp.berkeley.edu/iths/Experiments_of_Concern_Portal.pdf [accessed 16 April 2010].

[25]. National Science Advisory Board for Biosecurity. Proposed framework for the oversight of dual-use life science research: strategies for minimizing the potential misuse of research information; June 2007. http://oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf [accessed 19 April 2010].

[26]. Clarke B. Beyond ‘the banality of evil’. Br J Pol Sci. 1980;10:417–439.

[27]. Arendt H. The human condition. Chicago and London: University of Chicago Press; 1958.



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