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August 2013,?No. 2? Vol. L, Security

¡°¸éing farewell to the century of physics, the one in which we split the atom and turned silicon into computing power. It's time to ring in the century of biotechnology.¡±¹

This article summarizes the results of a qualitative risk assessment project on the biosecurity implications of developments in synthetic biology and nanobiotechnology carried out by the United Nations Interregional Crime and Justice Research Institute (UNICRI).²

Since the anthrax letter scare in the aftermath of 11 September 2001, attention in security policy discussions has shifted away from biological weapons and bioterrorism. It became increasingly clear that the acquisition of the necessary expertise and resources, as well as the successful execution of a biological attack, are far more complex than previously thought. Future advances in the field of biotechnology, however, might have the potential to change that. Even though the possible features and true potential of the coming biological revolution heralded by many observers is still a matter of controversy, it seems prudent to assess the security policy challenges of progress in biotechnology at an early stage, while allowing for the unhindered development of beneficial applications.

Forecasts for our future suggest that the revolution in biotechnology will bring about a transformation of society with the potential to yield enormous benefits. Nowhere is this development more visible than in the cutting-edge fields of synthetic biology and nanobiotechnology. The stated aim of these disciplines is both ambitious and controversial¡ªthe transformation of biology from a natural science into an applied engineering discipline.

ENGINEERING BIOLOGY

Largely owed to the development and ongoing advancement of automated machines that can sequence (i.e., read) and synthesize (i.e., write) genetic material such as DNA from chemical precursor substances, synthetic biology promises to enable the modification or creation of microorganisms for the production of pharmaceuticals, the remediation of polluted sites and the generation of biofuels. Although there is no single, agreed upon definition of ¡°synthetic biology¡±, it can be broadly understood as ¡°the deliberate design of biological systems and living organisms using engineering principles¡±.³

Within synthetic biology, a number of approaches can be distinguished. One basic possibility is to synthesize the entire genome, or parts thereof, of a known microorganism. Today, many scientists order DNA fragments via the Internet from commercial DNA synthesis providers. In another approach, attempts are made to construct a minimal genome reduced to the essential genes required for life in order to serve as the chassis for mounting genetic modules. At the same time, there is intense research into the development of such standardized genetic modules or biological circuits that can be added to the minimal genome in order to carry out predefined tasks¡ªa long the lines of modular construction in many industries. That would allow the chassis organism to generate specific metabolic pathways or other desired characteristics.

Should synthetic biology evolve into a full biological engineering discipline, it could prompt a qualitative shift in capacity compared to standard recombinant DNA approaches. Of particular note would be the dramatic increase in the number of potential users, significant improvements in the reliability of biology-based technology, a substantive reduction in the time taken to translate science into application, as well as distinctly lower resource requirements. Correspondingly, there is already a growing community of amateur biologists or biohackers in context of modern day biology who conduct biological work outside of conventional research institutions, similar to the beginnings of the information technology industry. The potential of synthetic biology to deskill the art of genetic engineering, by making the design and construction of living systems easier and more widely accessible, is deemed to pose new opportunities and risks. Whether or not synthetic biology will achieve its stated aims and become a true engineering discipline remains to be seen.

Nanotechnology can be described as an array of fundamental knowledge and enabling technologies resulting from efforts to understand and control the properties and function of matter at the nanoscale. Nanotechnology is not a specific determinate homogenous entity, but a collection of diverse capabilities and applications. Nanobiotechnology, as the name suggests, refers to the interface between, and convergence of, nano- and bio-technology. Nanobiotechnology can be broadly described as ¡°a field that applies the nanoscale principles and techniques to understand and transform biosystems and which uses biological principles and materials to create new devices and systems integrated from the nanoscale¡±. ⁴

Nanobiotechnology is expected to provide new and improved systems for medical diagnostics, targeted drug delivery, as well as enhanced therapeutics and pharmaceuticals.? In particular, therapies are researched that facilitate the targeted delivery and controlled release of drugs and genes to affected cells, where the impact is most effective and precise, without harming neighbouring cells or tissue. Another application includes so-called ¡° lab-on-a-chip¡± technologies that could be used for the real-time detection and analysis of diseases, cells, and microorganisms, including the detection of pathogens used in a bio- weapons attack.

THE DUAL- USE DILEMMA

As with every new technology, predictable and unforeseeable risks for society are created, ranging from unintended consequences that are harmful to human health and the environment (biosafety) to the deliberate misuse to cause harm (biosecurity). The same advances that could bring so many benefits could also enable the development of new and improved biological weapons. The so-called dual-use problem in synthetic biology and nanobiotechnology, as in biotechnology in general, is virtually universal. Almost every potential security risk can be derived from completely legitimate research endeavours and developments. Every major breakthrough in science has been applied for malign ends and the life sciences are no exception.

The application of synthetic biology and nanobiotechnology for nefarious purposes is unlikely in the short to medium term. As the stated aim of synthetic biology is to make biological technology more reliable, easier, cheaper and faster, there could be a significant risk for hostile application in the longer term, should its potential be realized. The risk or threat posed by a malign actor with access to a full-fledged biological engineering capacity would be quite different from that which we face today.

As an enabling tool, and in addition to assisting in many beneficial applications, synthetic biology could, in the future, facilitate the work of those attempting to acquire and use biological weapons. More dangerous and controllable pathogens could be engineered t hat lead to novel possibilities in designing bioweapons. Metabolic pathway engineering might confer new qualities and attributes upon biological agents and offer options for new types of weapons. The ability to manipulate pathogens systematically for specific ends could also assist in overcoming current operational hurdles to an effective attack, such as detection modalities, challenges to effective release, and environmental instability. This could have t he negative effect of making bioweapons cheaper and easier to acquire, eventually making their use more likely; more reliable and controllable, making them more desirable; and more effective thereby increasing their potential impact.

Such misuse of applications does not inherently depend on specific developments in synthetic biology and could also be achieved by way of alternative biotechnology options. Advances in synthetic biology might, however, make them available sooner, and facilitate acquisition of the necessary capabilities.

Nanobiotechnology also offers a multitude of potential risk scenarios of varying likelihood and potential consequence. In particular, nanocarrier and nanoencapsulation technologies, which are being developed in t he pharmaceutical industry for the efficient and targeted delivery of medicines, might be misused for the development of improved bioweapons by loading the carriers or capsules with a biological agent instead of beneficial drugs. Nanomaterials might facilitate the weaponization of pathogens by enhancing their environmental stability; they may be used to transport and/or target a pathogen to specific cells or organs; they may help to avoid the timely detection of a pathogen release or its rapid identification; and they could considerably improve the efficacy of delivery systems. Many of these possibilities would remove previous operational obstacles to biological weapons attacks and could make an attack more controllable, harder to detect, and hence more attractive.

However, it is important to keep in mind that the ability to respond to an attack is also a function of risk. Synthetic biology and nanobiotechnology will offer just as many, if not more, opportunities to develop prophylactics and therapeutics as it will with regard to weapons. It is too early to establish t heir net effect with regard to compounding as well as mitigating biological risks and threats.

In addition, both disciplines are still in their infancy, and the majority of work that is being done is on the level of basic research. The technical hurdles are considerable, and the required know-how is still concentrated in a relatively small scientific community. While it is theoretically possible for non-state actors to develop a synthetic biology or nanobiotechnology-based approach to acquire or use biological weapons, such a scenario is highly unlikely for the foreseeable future. Alternative acquisition routes and weapons systems will likely remain prevalent. While they currently would likely resort to easier and cruder means of developing and employing a biological weapon, technical progress in the coming decades might actually reverse this situation, and the vast field of biology might become more accessible to non-experts.

Nonetheless, the tools, techniques and approaches that currently lie outside the grasp of small groups are within the capabilities of states and large organizations, should they choose to invest sufficient time, resources and money. They would likely be in a position to use synthetic biology and nanobiotechnology to facilitate their acquisition or use of biological weapons. Over the longer term, synthetic biology and nanobiotechnology could significantly lower the hurdles such actors face. In this context, however, it is important to note that any application of synthetic biology and nanobiotechnology for acquiring or using biological weapons would be covered under the terms of the Biological Weapons Convention (BWC). Many would fall under the Chemical Weapons Convention as well and, therefore, be inconsistent with international law.

TOWARDS A CULTURE OF AWARENESS IN RESPONSIBLE BIOTECHNOLOGY

The nature of progress in biotechnology will, if it has not already, negate the ability to control the technology with traditional means. Synthetic biology and nanobiotechnology might constitute initial steps towards a qualitative and quantitative paradigm shift in biotechnology and may revolutionize the manner in and scale at which biological work will be conducted in the future. Unlike the case of nuclear technology, expertise, materials and equipment are already available in varying degrees around the globe and, accordingly, the proliferation of knowledge and expertise, although not necessarily weapons-related, has already taken place. Due to the problem of dual use, it is nearly impossible to even identify, let alone control bioweapons-related activities.

While international arms control agreements and norms such as BWC should be strengthened in order to continue to play an important role, the increasing penetration of society by biotechnology clearly warrants a broader policy response to tackle the wider societal impacts. In addition to controlling access through international arms control measures and strengthening established norms against bioweapons development and use, the international community should complement traditional approaches with innovative concepts. The focus should be shifted towards creating a web of prevention based on the shared responsibility of politics, industry, science and society to reinforce a culture of safety and security in biotechnology and minimize the risks by engaging relevant communities and empowering various actors to detect and report abuses. This requires fostering a worldwide culture of awareness and responsibility in biotechnology as well as building a network of relevant public and private actors, top-down and bottom-up measures, initiatives and checks on the national and international levels covering relevant activities and linking all levels of society in a systematic way.

The views expressed in this article are those of the author and not those of FDFA or UNICRI.

Notes

1??? Isaacson, W. ¡°The Biotech Century¡±, Time magazine, 11 January 1999.

2?? UNICRI, Turin, Italy. Security Implications of Synthetic Biology and Nanobiotechnology ¨C A Risk and Response Assessment of Advances in Biotechnology (2012).?See . (sic)

3??? Balmer, A. and Martin, P., Synthetic Biology: Social and Ethical Challenges. Institute for Science and Society (University of Nottingham, 2008), p. 3.

4?? ?Roco, M.C., ¡°Nanotechnology: convergence with modern biology and medicine¡±, Current Opinion in Biotechnology, vol. 14 (2003) p. 337.