Summary

S.1 INTRODUCTION

Over the past decade, national and international scientific organizations have become increasingly engaged in considering how to respond to the biosecurity implications of developments in the life sciences and in assessing trends in science and technology (S&T) relevant to biological and chemical weapons nonproliferation. The latest example is an international workshop, Trends in Science and Technology Relevant to the Biological Weapons Convention, held October 31-November 3, 2010, at the Institute of Biophysics of the Chinese Academy of Sciences in Beijing. The workshop and the subsequent final report are intended to be independent contributions from the international scientific community to the Seventh Review Conference of the Biological and Toxin Weapons Convention (BWC), which will be held in December 2011.

The workshop was planned by an international committee appointed by the National Research Council (NRC) of the National Academy of Sciences and convened in cooperation with IAP—the Global Network of Science Academies, the International Union of Biochemistry and Molecular Biology (IUBMB), the International Union of Microbiological Societies (IUMS), and the Chinese Academy of Sciences. The statement of task for the committee may be found in Box S.1 below; brief biographies of the members of the committee, information about the convening organizations, and the workshop agenda and participant list, may be found in Appendixes A-C of this report.



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Summary S.1 INTRODUCTION O ver the past decade, national and international scientific organi- zations have become increasingly engaged in considering how to respond to the biosecurity implications of developments in the life sciences and in assessing trends in science and technology (S&T) relevant to biological and chemical weapons nonproliferation. The latest example is an international workshop, Trends in Science and Technology Relevant to the Biological Weapons Convention, held October 31-November 3, 2010, at the Institute of Biophysics of the Chinese Academy of Sciences in Beijing. The workshop and the subsequent final report are intended to be independent contributions from the international scientific community to the Seventh Review Conference of the Biological and Toxin Weapons Convention (BWC), which will be held in December 2011. The workshop was planned by an international committee appointed by the National Research Council (NRC) of the National Academy of Sciences and convened in cooperation with IAP—the Global Network of Science Academies, the International Union of Biochemistry and Molecu- lar Biology (IUBMB), the International Union of Microbiological Societies (IUMS), and the Chinese Academy of Sciences. The statement of task for the committee may be found in Box S.1 below; brief biographies of the members of the committee, information about the convening organiza - tions, and the workshop agenda and participant list, may be found in Appendixes A-C of this report. 1

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2 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION BOX S.1 Statement of Task An ad hoc committee with significant international membership will be organized by the NRC to: • Plan an international workshop to survey key trends in areas of science & technology (S&T) that might be potentially relevant to the development of new or more deadly biological weapons and/or to developments in de- tection, diagnostics, therapeutics, or vaccines that could affect potential prevention and response to biological attacks. The developments in science discussed at the workshop are likely to be in areas such as immunol- ogy, neuroscience, synthetic biology, aerosol and other controlled delivery mechanisms, or others; the specific S&T areas and trends to be discussed during the workshop will be selected by the committee. • Prepare a report of the workshop that would provide findings, based on the consensus of the committee, about the state of the science in the topics discussed at the workshop. The report will also explore potential implica- tions for the Biological Weapons Convention as an independent input from the scientific community to the treaty’s Seventh Review Conference in 2011. The report would not make recommendations about actions to address any of the potential implications. • In advance of the final report, a brief, staff-authored summary will be pro- duced as a stand-alone document to provide a factual overview of the technical material presented by the speakers. The workshop provided an opportunity for the scientific community to discuss the implications of recent developments in S&T for multiple aspects of the BWC (a brief description of the key provisions of several relevant BWC articles may be found in Box S.2). For example, a con- tinuing question for the treaty’s review conferences is whether scientific developments yield new or novel types of agents or materials that are not captured by Article I, which defines the scope of the treaty’s prohibitions as “microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.” More broadly, however, developments in S&T also affect the other key articles of the convention that provide for the treaty’s operation, such as the adequacy of national implementation of the convention through national policies and regulatory systems (Article IV), the capabilities to carry out investigations of alleged use of biological weapons (Article VI), and the design of inter- national cooperation to ensure that all States Parties (i.e., those who have signed and ratified the agreement) have access to the benefits of peaceful applications of biology (Article X).

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3 SUMMARY The meeting benefited from being able to draw on the diverse per- spectives and active engagement of the participants through both plenary and breakout discussion sessions. Almost 80 scientists and policy makers from 28 countries and several international organizations took part in the workshop, with a mix of scientists and engineers currently engaged in research and technical experts from government and nongovernmental organizations, many of whom are also practicing scientists, who could help draw out potential implications for the BWC. The speakers for the S&T sessions were asked to focus on the “state of the science” with regard to their topics; in a few cases they also offered additional comments on the implications and applications for the BWC. The subsequent plenary discussions, and particularly the breakout sessions, further explored the implications. The workshop participants also discussed ways in which the BWC and its States Parties could continue to follow trends in S&T, including potential mechanisms for more systematic engagement with the scientific community. Given the immense diversity of current research and development, the report is only able to provide an overview of the areas of science and technology the committee believes are potentially relevant to the future of the BWC, although there is an effort to identify areas that seemed particu- larly ripe for further exploration and analysis. The report offers findings BOX S.2 Key Provisions of Several Relevant BWC Articles • Never under any circumstances to acquire or retain biological weapons (Article I) • To destroy or divert to peaceful purposes biological weapons and associ- ated resources prior to joining (Article II) • Not to transfer, or in any way assist, encourage or induce anyone else to acquire or retain biological weapons (Article III) • To take any national measures necessary to implement the provisions of the BWC domestically (Article IV) • To consult bilaterally and multilaterally to solve any problems with the imple- mentation of the BWC (Article V) • To request the UN Security Council to investigate alleged breaches of the BWC and to comply with its subsequent decisions (Article VI) • To assist States which have been exposed to a danger as a result of a violation of the BWC (Article VII) • To do all of the above in a way that encourages the peaceful uses of biologi- cal science and technology (Article X) SOURCE: BWC ISU, 2011.

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4 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION and conclusions organized around three fundamental and frequently cited trends in S&T that affect the scope and operation of the convention: • The rapid pace of change in the life sciences and related fields; • The increasing diffusion of life sciences research capacity and its applications, both internationally and beyond traditional research institutions; and • The extent to which additional scientific and technical disciplines beyond biology are increasingly involved in life sciences research. The report does not make recommendations about policy options to respond to the implications of the identified trends. The choice of such responses rests with the 164 States Parties to the Convention, who must take into account multiple factors beyond the project’s focus on the state of the science. S.2 PACE OF S&T DEVELOPMENTS Continued progress is being made in a wide variety of S&T areas, although the committee did not identify any game-changing advances since 2006 that fundamentally alter the nature of life sciences research. Life sciences research continues to advance rapidly and is expected to do so for the foreseeable future. Key advances achieved in one field may also combine with developments in others to achieve new opportunities and new applications. One example is the interaction of research in fields such as immunology, neuroscience, and systems biology with develop- ments in “omics” technologies such as genomics and proteomics, which undertake holistic analyses of a set of biological information to achieve a comprehensive understanding of its structure, function, interactions, and other properties. The results are providing scientists with information to better understand biological processes, helping to support a more com - plete understanding of human, animal, and plant variability and its rela - tionship to disease, and identifying and characterizing new microbes and their roles in multiple environments. Scientists actively seek to integrate information at multiple levels in order to support rational engineering and design. Although advances in S&T are increasing the overall under- standing of biological systems, the extraordinary complexity of biology and the challenges this complexity presents to the effective understanding and design of biological systems remain significant barriers; this complex- ity is likely to remain a defining feature of the biological sciences for the foreseeable future. Developments in S&T are also changing the nature of biological production, advancing delivery systems, and underpinning the ongoing development of biosensors and detectors.

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5 SUMMARY There has been particularly rapid progress in both the availability and power of enabling technologies that underpin life sciences research, including computational resources, communication resources, and high throughput laboratory technologies. The computational power available to researchers continues to increase, through specialized stand-alone com- puters and through distributed computing networks. The use of high throughput sample handling and analysis methods has become wide- spread, and these tools increase the speed with which researchers can conduct studies as well as the volume of data they can obtain. At the same time, new methods of communication and information sharing enhance scientific collaboration and support research progress. S.3 DIFFUSION OF RESEARCH AND CAPACITY The increasingly widespread access and ease of use of communica- tions technologies, combined with growing availability of resources to support research, are helping to support the continuing expansion of global research capacity and an ever larger number of international col- laborations in science and technology. The workshop highlighted that international S&T collaborations are occurring not only among research - ers in scientifically developed countries and between researchers in devel- oped and developing countries, but also among regional networks and increasingly among scientists within developing countries. It also under- scored that a growing number of “developing” countries already have impressive scientific sectors. Advanced S&T capacity is far from evenly distributed worldwide, and researchers in developing countries may still face problems in gaining access to resources and knowledge, but these trends are expected to continue and accelerate. The continuing, rapid diffusion of research capacity and knowledge makes the commitments of States Parties in Article III to restrict access to knowledge, materials, and technologies for anything other than purposes permitted by the Convention more challenging. Given that there is little hope of reversing this trend—and multiple reasons beyond the commit - ments in Article X to see the diffusion as positive and beneficial—this argues for at least two important findings. First, it suggests the importance of continuing attention to monitoring and assessing the diffusion to try to anticipate any potential negative consequences and to strengthening the capacity of States Parties to address them, for example through their Arti - cle IV commitments to national implementation. Second, it underscores the potential for a much larger number of States Parties to contribute to the implementation of the Convention, for example by expanding global public health and disease surveillance capabilities, or playing leadership roles in capacity-building in their regions. Two examples, one current—

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6 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION global disease surveillance—and one potential—developing scientific capacity in microbial forensics—illustrate the positive aspects of diffusion. There is also another important form of diffusion: the increasing abil - ity to do life sciences research outside traditional research institutions. In some cases these are trained researchers taking advantage of commercial kits and services, as well as the availability of secondhand equipment, to build their own laboratories and conduct experiments. In others it enables less trained practitioners to perform experiments without having the detailed biological or mechanistic understanding previously required in the life sciences. This is exemplified by innovative approaches to engag - ing students in hands-on research early in their studies and the expand - ing interest in what is frequently called “amateur,” “garage,” or “do-it- yourself” (DIY) biology. There are encouraging examples of initiatives from within and outside these communities to foster cultures of safety, security, and ethics, but it underscores the need to understand how train- ing and know-how are propagated and cultures of safety are developed in such non-institutional environments. However, although commercial life science kits and services and other advances such as standardized DNA parts provide efficiencies and ease of use, successful achievement of experimental goals generally relies on more than these products. Valuable knowledge and skills are also acquired through experience, and the importance of having these additional lev- els of knowledge increases with the complexity of the research projects undertaken. S.4 INTEGRATION OF LIFE SCIENCES WITH OTHER DISCIPLINES Life sciences research draws on the expertise not only of biologists, but also increasingly of scientists from engineering, physics, mathemat- ics, computer science, chemistry, materials science, and many other disci- plines. The multidisciplinary and integrative nature of modern life sciences research and the diversity of fields relevant to the future of the BWC were reflected in the Beijing workshop. The convergence of disciplines, particu- larly between biology and chemistry, may pose challenges to the operation of regimes like the BWC and the Chemical Weapons Convention (CWC). New scientific developments might alter or expand the types of agents that could be of concern as biological or chemical weapons or might alter or expand the definitions of which molecules fall under the purview of both treaties. As science continues to advance, the convergence of multiple disciplines, including the life, chemical, physical, mathematical, compu- tational, and engineering sciences, will continue and the developments

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7 SUMMARY that this convergence enables will be relevant to the BWC. The science community could play a role in exploring the technical understanding of converging S&T areas to help inform further policy discussions. The monitoring of scientific developments that integrate these fields and the assessment of their implications will need to draw on expertise from a range of disciplines. S.5 DRIVERS AND ROADBLOCKS Engaging a range of expertise within the scientific community, from academia, industry, and government, can contribute to efforts both to monitor the state of science and technology and to assess the implications of developments for the scope and operations of the BWC. In addition to tracking advances across diverse fields, the scientific community can contribute to a better appreciation of both the drivers and the roadblocks that broadly affect how S&T actually develops. Examples include the differential distribution of commercial markets for research products and the current challenge of developing mathematical models able to successfully capture the complexity of biological systems. Tracking and analyzing the impact of these forces should also be considered areas of potential interest for future monitoring of S&T trends. The report notes a number of current examples, and also suggests that an area for future in-depth analysis is the changing nature of tacit knowledge, of which intangible technology is a subset, as kits and other resources make it easier for less skilled individuals to carry out work that once required significant training. S.6 LOOKING AHEAD: FUTURE APPROACHES TO MONITORING S&T TRENDS FOR THE BWC The preparations for the Seventh Review Conference have high- lighted the potential for adopting a more systematic process to monitor and assess developments in S&T. Whatever sort of mechanism is selected should depend on how the States Parties define their objectives in review- ing areas of S&T and the desired outcomes of the process. These decisions will impact both the types of activities that are undertaken and the timing of activities in order to most effectively meet these objectives. Interna - tional scientific organizations are one potential resource for gaining access to a wide range of expertise to assist in understanding the “state of the science” and in assessing its implications. Box S.3 presents the committee’s nine findings about the state of sci- ence and technology and their relevance to the BWC.

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8 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION BOX S.3 Findings I. The committee did not identify any discoveries that fundamentally altered the nature of life sciences research since 2006. However, advances in S&T on many fronts have increased our overall understanding and exploitation of biological systems, despite their daunting complexity. II. There has been particularly rapid progress in the power of, and access to, en- abling technologies, especially those depending upon increased computing power. These include high throughput laboratory technologies and computa- tional and communication resources. This has the following consequences: • ollaborations between individual investigators, global networks of re- C searchers, and the formation of ”virtual laboratories” are growing trends in the life sciences. • ncreasing access to sophisticated reagents such as standardized DNA I “parts” and easy-to-use commercial kits and services has placed some hitherto advanced technologies within the reach of less highly trained prac- titioners, and has expanded the global spread of life sciences research and its industrial applications. • lthough first class research continues to rely heavily upon tacit knowledge, A the availability of web-based technologies is facilitating the transfer of tacit knowledge through the creation of worldwide formal or informal learning communities or partnerships. • hese technologies reduce the barriers to the spread of S&T knowledge for T responsible, educational purposes, thus creating more favorable conditions for international cooperation in the peaceful application of the life sciences. • t the same time, we must recognize that these same barriers also serve A as impediments to misuse. This is an area that would benefit from more in- depth analysis to gain a more nuanced understanding of the developments and trends and their impact on the norm against biological weapons. III. ultiple disciplines, including the life, chemical, physical, mathematical, M computational, and engineering sciences, are converging. This trend will continue and is relevant to the BWC as well as the CWC. The impact of this convergence on the existing arms control system must be better understood in order to draw conclusions about whether adaptations in the application of the existing regimes may be required, and if so, what they should be. IV. he field of bioreactor research and the use of transgenic organisms to T produce commercially or medically important proteins have seen impres- sive advances. These have reduced the time needed to produce proteins and have the potential to affect the scale of the facilities required. This has obvious implications for the BWC, for example with regard to the measures States Parties need to take to implement the BWC and to prevent the use of biological or toxin agents for hostile purposes. V. he development of microbial forensics illustrates one way that life sciences T research from around the world can support the BWC and create etter b

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9 SUMMARY tools to investigate and discriminate between natural and deliberate disease outbreaks. VI. otable technical advances have been made at the level of individual-use N biosensor detector systems, although there are limitations to what can be achieved given that sensor development must balance factors such as speci- ficity, sensitivity, range of target molecules analyzed, and type of use. VII. he combination of approaches including improved biosensors, epidemio- T logical monitoring, vaccine research, forensics, and other laboratory inves- tigations can contribute to effective disease detection, investigation, and response systems worldwide. VIII. These advances underscore the potential for more States Parties to contrib- ute to the implementation of the BWC, for example by expanding their global public health and disease surveillance capabilities, or by playing leadership roles in capacity building in their regions. IX. ertain scientific and technical roadblocks (e.g., drug delivery technologies) C impede future progress, but once overcome, would presage a phase of rapid development. The international scientific community can play a useful role in tracking trends and developments in S&T. Its continued engagement with the BWC is essential to identifying these key scientific hurdles and when they have been overcome. S.7 CONCLUSIONS Many of the committee’s individual findings about particular devel - opments in S&T will not surprise those who follow trends in research that are potentially relevant to the BWC. Taken together, they represent the S&T reality in which the Convention is now operating and the challenges and opportunities this reality poses for the Seventh Review Conference. They also lead the committee to four general conclusions: Conclusion 1: None of the trends surveyed for this report cur- rently falls outside the scope of Article I. The language of the treaty, as reinforced by the common understandings reached in prior review conferences, provides a degree of flexibility that has so far allowed it to adapt to progress in the life sciences and related scientific fields. The committee recognizes, however, that as new developments arise, including in fields of research that this report did not assess in depth, there may be surprise discoveries; hence, continued monitoring of advances in the life sciences and evaluation of their relevance for the BWC will be important.

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10 TRENDS RELEVANT TO THE BIOLOGICAL WEAPONS CONVENTION Conclusion 2: Beyond the question of whether these trends pose fundamental challenges to the scope of the treaty, every major article of the treaty will be affected by the developments surveyed. The trends may pose challenges to the implementation of some aspects, but they also offer important opportunities to support the operation of the convention. Conclusion 3: The three broad trends that provided the organiza - tion of the report—the increasing pace, diffusion, and convergence of S&T—will continue for the foreseeable future. The diversity of the fields potentially relevant to the BWC and the potential for surprise discoveries make efforts to predict developments problematic. Within these trends, however, particular fields will be affected in important ways by factors such as commercial interests that drive developments at different rates, as well as roadblocks that impede progress. Gaining a deeper understanding of the drivers and roadblocks would provide a more meaningful picture of how and when continuing S&T develop - ments are likely to affect the convention. Conclusion 4: There are potential roles for the scientific community in helping to monitor trends in S&T and to assess their implications for the BWC, and there are a number of mechanisms by which input and advice could be provided. The most effective starting point for the Seventh Review Conference, therefore, would be to address the func - tions that such advice and analysis will serve for the future operation of the convention, including increasing the capacity of States Parties to participate fully in its implementation.