The principal goal of the 2010 workshop was to draw on the expertise of the international scientific community to provide a broad, independent picture of the state of science and technology (S&T) research and development relevant to the Biological and Toxin Weapons Convention (BWC). In Chapters 2-4, the committee examined three key trends that emerged from the meeting: the rapid pace of developments, the increasing diffusion of research capacity and applications, and the integration of multiple disciplines that characterizes many areas of life sciences research. This chapter focuses on how the insights gained through processes like the workshop can be analyzed and applied.
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. Taking account of developments in S&T in ways that are useful to the BWC will require States Parties and experts in Geneva to have a reasonable grasp of the state of the science as it evolves, including a sense of the forces that drive different areas at different rates and the inevitable roadblocks that hamper progress. Input from experts from the broader scientific community, in conjunction with government technical experts, who often are also practicing scientists, may be particularly suited to the task of understanding these factors. Although there is a role for the scientific community in helping to assess the implications of S&T for the treaty, this is clearly also a matter for discussion among government technical experts, and
ultimately by States Parties when discussions surrounding S&T move into the realm of policy options and potential action.
This chapter has three major sections. The first section examines the forces mentioned above that broadly affect how S&T trends develop, including the differential impact of drivers such as commercial interests, some of the barriers to the distribution of scientific knowledge and capacity, and other factors that may present current roadblocks to progress. Tracking and analyzing the impact of these factors could be considered areas of potential interest for future monitoring of S&T trends. In the second section, the committee draws on the workshop results to highlight the relevance of S&T to the BWC’s provisions. The final section discusses possible roles for the scientific community in contributing to future BWC discussions of S&T. The chapter ends with the committee’s overall findings and conclusions.
The difficulty of attempting to predict future trends and developments is well recognized, and it was noted during the workshop that one should always prepare to be surprised. With this caveat in mind, the committee did not attempt to forecast the state of life sciences knowledge in the years ahead. However, the committee did discuss some of the common drivers of life sciences research, and these are illustrated with brief examples, below. S&T areas that are being pushed forward strongly by these drivers would be expected to continue to rapidly advance. The more general impetus for S&T advances arising from investments as part of broader national development strategies was discussed in Chapter 3 (see Section 3.1.2). Investments are important, but the amount of money invested is not necessarily a sign that one field will advance more rapidly than another. To date, for example, the substantial investments in systems and synthetic biology have yielded only limited commercial products.
Commercial markets are a powerful driver of life sciences research, in the healthcare and pharmaceutical industries as well as in sectors such as agriculture and energy. Several of the S&T areas discussed during the workshop appear to have commercial drivers for further development. These include diagnostic biosensors, advanced delivery technologies for controlled release and targeted delivery of biological molecules, protein production technology, and the potential applications derived from omics knowledge in areas such as personalized medicine. Fields such as synthetic biology, which likely have future medical applications, are also expected to have valuable applications in areas such as bioenergy and food production (Lee et al., 2008; NRC, 2009e). Developments in
neuroscience, particularly advances in the mind-machine interface, may clearly benefit patients with medical disabilities such as paralysis or loss of limbs. However, an interesting commercial driver in this field may also be the entertainment industry. The ability to remotely control computer interfaces and to produce sensations such as motion could be integrated into videogames to heighten the experience. The entertainment company Sony, for example, has reportedly filed a patent application for a device that emits ultrasound pulses to influence brain waves (Hogan and Fox, 2005). Many technologies that underpin and enable modern life sciences research, such as powerful computer networks and mobile and Internet-based communications systems, are broadly applicable far beyond the life sciences. Advances in these areas are driven by numerous markets and applications, appear to have moved forward especially rapidly, and would be expected to continue advancing.
Other areas of S&T lack strong commercial drivers and therefore rely on government investments to move forward. In at least some countries, government investments in defense-related research can be strong drivers for some areas of basic and applied research. The most dramatic case may be the United States’ investments in biodefense; by one estimate, the government has spent $19 billion on research out of a total biodefense budget of $60 billion (Kaiser, 2011:1214).
Another arena where government and also philanthropic investments are critical is public health. Public health applications in general, including the development of new vaccines and antibiotics, typically exhibit market cost/benefit conditions that make them less attractive to the pharmaceutical industry absent government incentives. These challenges include the cost of R&D expenses compared to likely market size and profits and regulatory and liability issues, among others (Jarvis, 2008; Kieny et al., 2004; Smith et al., 2009). These same market challenges affect the development of vaccines and medical countermeasures against biothreat agents, because diseases of concern as potential bioweapons are often not endemic in the United States or Europe, the immune correlates of protection may not be well known, suitable nonhuman animal models may not exist, and there is no guarantee that a particular product would be needed given the hypothetical nature of a future bioweapons attack. Therefore, developing a licensable product with no clear end market may be challenging from both scientific and regulatory standpoints. As a result, incentives such as guaranteed government purchase orders or vouchers for priority regulatory review of another (usually more lucrative) company product have been used to help stimulate this field. Public health disease surveillance networks are another area with limited commercial markets but clear national and international benefits and that also rely on government and nonprofit investments.
Overall, areas of technology with strong commercial drivers seem likely to develop particularly rapidly, although the committee noted
that the optimum combination of variables for a particular commercial application may not be the same as that for a dedicated public health or biosecurity application. In these cases, government investments may be required to adapt technologies to meet the specific combinations of needed operating conditions. For areas that do not appear to have strong commercial market drivers, government investments may also be particularly important in advancing the field.
Discussions of advances in science and technology can create the impression of a dynamic process characterized by uninterrupted progress, sometimes at daunting speed. As anyone engaged in research appreciates all too well, there can be many failures on the way to eventual success, and the path is not always predictable. Entire fields may face particular technical challenges that, until surmounted, represent significant roadblocks to progress. Once overcome, however, progress may be rapid (see Box 5.1 for some well-known examples). A number of current roadblocks were discussed in Chapter 2 and could be useful focal points for efforts to monitor areas of S&T relevant to the BWC. Other challenges may reside in the nature of how science is done or used, and as they change there can be impacts on how easily science is used and applied, whether for beneficial or malicious purposes. That is the subject of the next section.
184.108.40.206 The Process of Knowledge Creation
and Barriers to Knowledge Transfer
From Data to Knowledge
As discussed in Chapter 2, advancing technologies within the omics fields, for example, generate large amounts of raw, discrete data (e.g., the results of nucleotide or amino acid sequencing, DNA and protein microarray results, nuclear magnetic resonance [NMR] and mass spectra, x-ray crystallographic images). These streams of data need to be managed, analyzed, and put in context in order to be converted to useful information. This process of converting data to information might include processing and representing data as graphs and charts to reveal patterns, for example. Because of the enormous volumes of data currently being generated, however, life scientists increasingly rely on information science (bioinformatics) and computer science expertise to create the databases, theories, and algorithms needed to analyze and transform these large data sets into information. A third and critical component is the organization, analysis, and conversion of biological information into knowledge, which involves a human dimension. This process of knowledge creation draws
FIGURE 5.1 The process of knowledge creation.
on multiple pieces of information as well as previously acquired knowledge and experience to enable a scientist to interpret the information, give it meaning, and make it usable for a specific purpose.
Another distinction that can be drawn is between the two forms of knowledge referred to as “explicit” and “tacit.” Explicit knowledge, which is frequently factual in nature, can be expressed in a relatively straightforward fashion and transmitted to another person. Tacit knowledge, on the other hand, resides within individuals, is based on experience and learning through doing, and is more difficult to convey. It has been stated that “practical knowledge has two dimensions—a visible, codified component that resembles the tip of an iceberg. The larger but crucial tacit component which lies submerged consists of values, procedures and tricks of the trade and cannot be easily documented or codified” (Rangachari, 2008).1 Figure 5.1 depicts this process of conversion from data to information, incorporation of multiple sources of information and experience into tacit knowledge, and then externalization of that knowledge into new, explicit knowledge that can be communicated to others. The understanding and appreciation of the role of tacit knowledge draws on contributions from the social and behavioral sciences, particularly the field of science and technology studies (Hackett et al., 2007).
Scientific Communication and Tacit Knowledge
Scientists attempt to convert the knowledge they possess into explicit forms to be shared with others, for example through conference presentations and the publication of journal articles. Not all aspects of tacit knowledge are easy to express and convey explicitly, however, and scientific training still makes use of an interactive apprenticeship process that draws on personal interactions with advisors and other experts in com-
1 In some cases, possessors of such tacit knowledge (either corporate or individuals) may not want to document or codify their knowledge, or in the case of the government employee, may be directed not to provide such information in a public report.
munities of practice to convey both forms of knowledge to new trainees. A large body of literature exists on the study of knowledge creation and conversion (Bathelt et al., 2004; Cross et al., 2001; Nonaka, 1994; Roberts, 2000), and it is not the committee’s purpose to summarize the entire field here. However, the committee noted two points especially relevant to trends in S&T:
• Data does not equal information does not equal knowledge. There is a significant time and processing component in the conversion of data from scientific experiments to usable knowledge, as well as a human dimension to this transformation. Although modern life sciences are rapidly generating large amounts of data, these data do not immediately or directly advance understanding of biological processes or provide the ability to accomplish a specific task.
• Challenges and bottlenecks can exist in the conversion process from data to knowledge. The complexity of biological systems, complications in distinguishing data from background noise, and other similar factors, create significant challenges in developing algorithms and models that help convert data to usable information, a point also highlighted by the workshop presentations (Pitt, 2010a). The difficulty in rendering certain aspects of tacit knowledge explicit and conveying it to others can create a bottleneck in the second step of the pathway, that is, the conversion of information to knowledge.
The extent to which tacit knowledge as described in the second bullet might help to prevent the misuse of S&T is briefly discussed in the next section.
Tacit Knowledge as a Potential Roadblock to Misuse of Life Sciences Research
Several authors have highlighted the roles of tacit knowledge and of social and organizational factors in achieving research success, including the creation of biological weapons (Ben Ouagrham-Gormley and Vogel, 2010; Suk et al., 2011; Vogel, 2006). A subset of tacit knowledge, for example, deemed “intangible technology,” is subject to export controls by a number of countries and international groups.2
It has also been suggested that tacit knowledge could serve as a roadblock to gaining weapons-relevant capabilities (Vogel, 2006). The study
2 The relationship between tacit knowledge and intangible technology is somewhat complicated because for export control purposes—where the term “intangible technology” is most relevant for BWC implementation—intangible technology also includes documentation, plans, etc., that are not part of most understandings of tacit knowledge.
of the research that led to the chemical synthesis of polio virus DNA and use of this DNA to create viral polio particles (Cello et al., 2002), which drew the attention of the biosecurity community and aroused concerns that the method could be harnessed by persons seeking to create harmful viruses, concluded that it could not be duplicated because of the tacit knowledge required to prepare the virus. Understanding the influence of barriers beyond extrinsic scientific knowledge on success in bioweapons-related research emerged from historical studies of the Soviet biological weapons program, where different facilities had different outcomes that correlated with differences in organizational style and research culture (Ben Ouagrham-Gormley and Vogel, 2010). Similarly, a study of scientists in biotechnology and pharmaceutical companies suggested that teams of scientists contributing different types of human capital were important for success (Hess and Rothaermel, 2010). The authors observed that “star” scientists served as important sources of intellectual capital, including tacit and exploratory knowledge and networks of connectedness. However, the authors also reported that the importance of these star scientists decreased “as the knowledge associated with biotechnology was disseminated through the scientific community” (Hess and Rothaermel, 2010:10), suggesting that the significance of different types of tacit knowledge may change as S&T areas mature and develop.
Multiple factors appear to be important to the success of high-tech research, and thus “technology is much more than the sum of its material and informational aspects. Social contingencies and tacit knowledge, serendipity and unpredictability, institutional memory, and many other factors are essential to the successful design and deployment of any given technology” (Suk et al., 2011). Explicit forms of scientific information are now readily available through open access journal articles and databases, and individual and group communication and collaboration have been made easier by the Internet, social media platforms, and mobile devices. Furthermore, small communities of amateur biologists have been established around the world. As these new developments continue to shape the culture of science, consideration of the extent to which tacit biological knowledge and other factors continue to create roadblocks to the potential misuse of biology or creation of a biological weapon may be useful.
Both the business and online learning communities have studied ways to convey tacit knowledge effectively within organizations and to students online (Anderson, 2008; Cummings and Teng, 2003; Nonaka, 1994). Lessons drawn from these groups’ experiences may help in assessing the significance of knowledge transfer barriers. If specific social media or other tools have proven particularly effective at conveying tacit knowledge or at integrating multiple streams of knowledge to tackle complex problems in the business or education communities, then monitoring whether these types of tools become commonly used within the scientific
community may provide a sense of when roadblocks related to scientific knowledge transfer are being overcome.
The increasing numbers and availability of kits and other tools to carry out laboratory procedures that were traditionally acquired as part of the hands-on learning described above (see Sections 3.1.2 on kits and services and 3.4 on how this is enabling the development of research communities outside traditional institutions) is a phenomenon that may affect the role of tacit knowledge. An increasing number of online resources provide step-by-step training, such as the Journal of Visualized Experiments (JoVE), which seeks to take
advantage of video technology to capture and transmit the multiple facets and intricacies of life science research. Visualization greatly facilitates the understanding and efficient reproduction of both basic and complex experimental techniques, thereby addressing two of the biggest challenges faced by today’s life science research community: i) low transparency and poor reproducibility of biological experiments and ii) time and labor-intensive nature of learning new experimental techniques. … Research progress and the translation of findings from the bench to clinical therapies relies on the rapid transfer of knowledge both within the research community and the general public. Written word and static picture-based traditional print journals are no longer sufficient to accurately transmit the intricacies of modern research. (JoVE website, http://www.jove.com/About.php?sectionid=-1)
This trend has led to discussions of the “de-skilling” of biology research (Mukunda et al., 2009; Schmidt, 2008; Tucker, 2011a). By permitting less skilled individuals to carry out more procedures, such materials and resources could reduce the importance of some forms of tacit knowledge and hence its role in limiting misuse. But there are also questions about the level of sophistication that could actually be achieved by practitioners without the deeper biological or mechanistic understanding that enables experienced researchers to respond to difficulties in the course of an experiment or effort to develop a weapons capability.3
The committee does not have an answer to the implications of the changes in the roadblocks provided by tacit knowledge to the potential misuses of life sciences research. The discussion is intended to highlight an area that could be the subject of future study and consideration as part of broader efforts to monitor S&T trends. It also notes the important role
3 For an example of the possible difficulties, see the report from the Center for a New American Security on the efforts by Aum Shimrikyo to acquire both biological and chemical weapons capabilities (Danzig et al., 2011).
that understanding how to propagate norms about responsible conduct of science would play in the development of any response.
220.127.116.11 Overcoming Roadblocks: Serendipitous Discoveries and
Those Enabled by Simultaneous Progress in Multiple Fields
Advances in technology that enable a deeper understanding of the processes and links between molecules, cells, organisms, and ecosystems have resulted in more detailed and thorough models of biological response and behavior than ever available before. However, these new technologies have also revealed a greater complexity within biological systems than previously known, and this complexity presents significant challenges to those modeling efforts. As a result, although our theoretical understanding has improved, the capacity to predict, ab initio, organism responses to changes in the molecular and biochemical structures within its cells remains largely out of reach. Biology remains at its core an empirical science and serendipitous discovery is still relatively common. A frequently cited example from an area of science with dual use potential is RNA interference (RNAi), whose initial discovery grew out of efforts by plant researchers to find ways to give petunias a deeper purple color (Chamberlin and Kwik Gronvall, 2007; Gilbert, 2010).
More and more researchers are crossing disciplinary and geographic boundaries and identifying new ways to tackle biological questions. It is probable that major advances in understanding and fine control of biological systems will be rapid relative to the past 5-10 years but one can expect that a number of them will come as surprises.
Major leaps in scientific understanding and the emergence of new fields of research often occur because multiple, parallel technologies have advanced concurrently to a stage where they can be drawn upon to create something new. For example, early efforts in synthetic biology drew upon x-ray crystallography; DNA sequencing and recombination techniques; the development of sensitive, small-scale analytical methods; and advances in modeling techniques and computing power. Today, there is a general sense within the life sciences community that many parallel tracks and fields of research are developing simultaneously. When advances in multiple fields reach a stage where they can be successfully combined to build upon each other, there will be the potential for the emergence of new fields of discovery and the development of new, powerful techniques for
manipulating and understanding biological systems. As just one possible example, combining the development of an aerosol delivery system able to effectively cross the blood brain barrier and deliver controlled quantities of a biologically active peptide drug to specific, targeted cells; more precise physiological understanding of how regulatory molecules affect the central nervous system and how such effects can be controlled; and cost-effective and scalable production of both the peptide and the delivery vector would significantly expand options for using peptide bioregulators to influence human systems. The emergence of new fields and new advances building on parallel developments will likely occur most often around applications and issues that are affected by the drivers described above, i.e., those that have strong economic and public health impacts, although they may also appear in other areas. The pace of research today suggests that new developments will be swept up very quickly into the general practice of biology and related fields.
5.1.3 Discussion and Implications
Certain scientific and technical roadblocks may impede future progress, but when they are overcome they will enable particularly rapid development to follow. Two examples from 20th-century life sciences are presented in Box 5.1.
The workshop and committee discussions highlighted several current roadblocks in the life sciences that could be subjects for future monitoring and assessments of S&T trends. These include:
• Advances in mathematical and computational modeling that are able to better account for biological complexity and to render the models more accurately predictive of biological behavior. To achieve this goal, sophisticated mathematics may be required to more accurately express biological systems as equations, given that biological systems do not always behave in precisely defined ways but instead exhibit variability and ranges of responses. In addition, increased computational power may be required to simultaneously solve the very large numbers of equations needed to describe a biological system.
• Developments in the understanding of immunology and the relationships of the immune system with other biological systems that would allow for controlled and predictive immune system modulation.
• The design and creation of more and more complex synthetic biological pathways.
• The development of more effective methods of targeted and controlled delivery, able to deliver high levels of a protein or drug
Overcoming Scientific Roadblocks: PCR and Penicillin
The dramatic explosion of research and application that can follow from overcoming a scientific roadblock is demonstrated by two well-known examples from 20th-century life sciences.
Polymerase Chain Reaction (PCR)
Scientists knew that the primary genetic material of life was encoded in DNA but were limited in their abilities to analyze and manipulate specific genes because any particular sample contained such a small quantity mixed among other genetic material. In the 1980s, Dr. Kary Mullis described a technique to amplify a specific DNA sequence multiple fold. PCR exploits key aspects of DNA replication: double-stranded pieces of DNA are separated at high temperature; short DNA primers flanking and complementary to the target DNA sequence are annealed at lower temperature; and the enzyme DNA polymerase synthesizes new DNA to copy the target sequence. These cycles of heating and cooling are repeated, doubling the amount of target DNA each time. Starting from a single DNA copy, 32 cycles of PCR will yield more than 1 million copies of the target sequence. This technique revolutionized molecular biology and paved the way for a subsequent explosion in genetic research. The ability to amplify individual DNA sequences greatly expanded the ability to detect and analyze gene mutations, to associate genetic changes with particular diseases, and to enable medical diagnosis and genetic screening. PCR is one of the fundamental techniques that underpin modern biotechnology.
In 1928, Alexander Fleming at St. Mary’s Hospital in London identified a mold from the genus Penicillium on a culture plate of Staphylococcus bacteria he had left on a lab bench. A substance released by the mold had killed the bacteria, leaving a plaque—he subsequently named this substance penicillin and tested its efficacy against various types of bacteria. Early studies on the potential disease-fighting properties of penicillin were severely hampered by difficulty isolating and producing it. In the late 1930s, Ernst Chain, Howard Florey, and Norman Heatley at the University of Oxford became interested in penicillin, studying its chemistry and working in collaboration with Andrew Moyer of the U.S. Department of Agriculture’s (USDA’s) Northern Regional Research Laboratory to significantly improve the ability to purify and produce it in larger quantities. The subsequent medical studies this enabled established penicillin as a “miracle drug” that dramatically improved treatment for bacterial diseases and started the age of antibiotic therapeutics. The discovery of penicillin also highlights the long-standing interdisciplinary nature of life sciences research—the combination of Fleming’s biological observations with the Oxford and USDA researchers’ chemical and production work, as well as the determination by Dorothy Hodgkin of penicillin’s molecular structure using x-ray crystallography, brought penicillin to the point that it could feasibly be tested and used clinically and helped facilitate the development of new antibiotics.
to a target cell or to express high levels of a gene within that cell, while minimizing destruction of the delivery vector and its drug or gene payload within the body and minimizing its uptake into non-specific cells and tissues.
• More accurate and detailed understanding of the nervous system and its relationship to other physiological systems, as well as mechanisms to effectively deliver a range of biologically relevant molecules to targeted nervous system cells.
• The development of real-time biosensors that can rapidly distinguish signal from noise for multiple substances under real-world conditions in small size and at reasonable cost.
The committee presents the research areas above as examples of significant current challenges based on the workshop discussions. If or when life sciences achieve one or more of these goals, further rapid developments in the field may follow. Continued tracking of trends and developments in S&T to identify when key scientific roadblocks have been overcome may be particularly helpful, and the scientific community can play a useful role in monitoring the state of the science in relevant areas.
In addition to these S&T challenges, the availability of web-based technologies can enable the transfer of tacit knowledge through the creation of formal or informal learning communities or from individual to individual. These technologies are used to reduce the barriers to S&T knowledge for responsible, educational purposes, but they may also potentially be used to provide access to tacit knowledge that acts as a barrier 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.
One of the primary themes to emerge from the workshop is the continuing relevance of S&T to the BWC. This relevance extends beyond concerns over the misuse of microbiology for the creation of pathogen weapons to include multiple areas of the life sciences and intersecting disciplines. The impact of the advances in S&T also affect the implementation of the treaty.
5.2.1 Article I: S&T and the Scope of the BWC
Many areas of S&T discussed at the workshop are potentially relevant to both the BWC’s scope and its implementation. Perhaps the most com-
mon motivation for regularly reviewing advances in S&T is to determine whether any new developments appear to fall outside of the current scope of the treaty, as articulated in Article I, which prohibits States Parties from undertaking to “develop, produce, stockpile or otherwise acquire or retain” both biological agents and their means of delivery “whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes” (United Nations, 2011). This has been an issue from the treaty’s earliest days; the treaty’s entry into force in 1975 coincided with the development of the technology to create recombinant DNA (rDNA). Among the concerns raised at the time was that “the technology might deliberately or inadvertently be used to create organisms with increased virulence or novel characteristics” (NRC, 2004:30). The First Review Conference in 1981 agreed that the prohibitions in Article I covered recent developments in S&T, including efforts to genetically engineer biological warfare agents (Sims, 1988). Subsequent review conferences reaffirmed the comprehensive coverage provided by Article I:
The Second, Third and Fourth Review Conferences, conscious of apprehensions arising from relevant scientific and technological developments, inter alia, in the fields of microbiology, genetic engineering and biotechnology, and the possibilities of their use for purposes inconsistent with the objectives and the provisions of the Convention, reaffirmed that the undertaking given by the States Parties in Article I applies to all such developments. The Fourth Review Conference supplemented the list of scientific and technological developments with molecular biology… and any applications resulting from genome studies [IV.I.6, III.I.3, II.I.4] (United Nations, 2007:4).
The report of the 2006 workshop at the Royal Society, which looked at trends in the early part of the decade, noted that the misapplication of any of the S&T developments it discussed would be covered by the general-purpose nature of the Article I prohibitions (Royal Society, 2006b). For example, the malign creation of a pathogen entirely through chemical synthetic techniques, the use of understandings gained through computer modeling and systems biology to manipulate biological pathways for harm, or the delivery as a bioweapon of DNA encoding a pathogen toxin so that the resulting toxin protein is produced within a host’s own cells, could all be addressed by the Article I prohibitions on agents of types and quantities having no peaceful purpose “whatever their origin or mechanism of production.” Similarly, the misuse of materials science to encapsulate drugs and genes into bioweapons consisting of nanoparticles or “artificial viruses” for improved biological targeting and uptake could be covered through the inclusion of delivery systems as part of the treaty’s prohibitions. “The Sixth Review Conference reaffirmed that
Article I applies to all scientific and technological developments in the life sciences and in other fields of science relevant to the Convention [VI.I.2]” (United Nations, 2007:5).
5.2.2 S&T and Implementation of the BWC
S&T developments are also relevant to the BWC beyond the issue of scope and the general prohibitions contained in Article I. S&T developments lend themselves particularly well to supporting articles that address States Parties’ implementation of BWC provisions (such as Article IV) and that emphasize international collaboration (such as Articles V and X). Table 5.1 sets out selected ways that developments in the life sciences might be relevant to the provisions of the BWC.
The potential dual use nature of multiple areas of life sciences research, coupled with the rapid progress in the fields described in Chapters 2 through 4, underscore the need for the scientific community to be aware of the legal prohibitions enshrined in the BWC and translated into domestic criminal legislation.4 Scientists also need to be engaged in helping policy makers understand the ways that scientific advances might affect such agreements. The role of the scientific community in providing factual information about S&T developments and in contributing to stakeholder discussions about their potential implications for international security in general and weapons of mass destruction in particular has been recognized for many years.5 As discussed in Chapter 1, international scientific organizations have been contributing to the BWC and the Chemical Weapons Convention (CWC) for almost a decade. Although it was not part of the formal mandate for the project, in anticipation of the likely discussions at the Seventh Review Conference, the workshop included consideration of the contributions of the scientific community to the BWC.
4 Article IV requires States Parties to enact measures to prohibit and prevent—therefore it is implicit on States Parties not only to enact domestic law, but also to undertake other measures to ensure its citizens (including the scientific community) do not violate the basic prohibitions of the BWC (a cooperative activity between the governments and the scientific communities).
5 Pioneering nuclear physicists, for example, recognized the potential implications of their research and were involved in promoting nonproliferation. This and other examples are discussed in Finney and Slaus (2010).
TABLE 5.1 Relevance of Trends in Science and Technology to the BWC: An Article-byArticle Summary
|BWC Article||Relationship to Selected S&T Developments|
I. Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain:
(1) 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;
(2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.
|The general prohibitions embodied in Article I apply to the misapplication of any of the S&T developments discussed at the workshop. This includes the use of synthetic techniques (e.g., chemical synthesis of nucleic acids and synthetic biology) as well as materials science and nanoscience technologies that could be used to develop targeted toxin and gene delivery systems.|
|II. Each State Party to this Convention undertakes to destroy, or to divert to peaceful purposes, as soon as possible but not later than nine months after entry into force of the Convention, all agents, toxins, weapons, equipment and means of delivery specified in Article I of the Convention, which are in its possession or under its jurisdiction or control. In implementing the provisions of this article all necessary safety precautions shall be observed to protect populations and the environment.||If destruction were ever needed, S&T advances in areas such as detection and surveillance technologies such as biosensors could also help States Parties monitor the process. Advances in vaccine and medical countermeasures development have the potential to contribute to appropriate safety precautions during destruction.|
|III. Each State Party to this Convention undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of this Convention.||Norms of responsible conduct within the scientific community can assist in establishing an environment that does not support misuse. The importance of enabling technologies and services in the life sciences and a partnership with the industries that supply the research community also contribute, for example in developing ways to evaluate gene synthesis requests against pathogen sequences.a The research community and industry can also be partners with the policy and legal communities in striking the appropriate balance between regulation and scientific progress.|
|IV. Each State Party to this Convention shall, in accordance with its constitutional processes, take any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition, or retention of the agents, toxins, weapons, equipment and means of delivery specified in Article I of the Convention, within the territory of such State, under its jurisdiction or under its control anywhere.||
Clarifications with regard to the coverage of advances in S&T under Article I could require additional legislative or regulatory steps by the States Parties under Article IV to embed them into national laws and regulations.
The increased power of and access to S&T could make it easier (subject to all the roadblocks discussed earlier) for terrorist and other non-state groups to develop and produce biological weapons, and thus trends in S&T are changing states’ ability to counter/prevent/respond to bioterrorism.
Awareness within the S&T community of the broad set of ethical norms and legal obligations that prohibit misuse, along with engagement in relevant discussions, is valuable in supporting the treaty.
|V. The States Parties to this Convention undertake to consult one another and to cooperate in solving any problems which may arise in relation to the objective of, or in the application of the provisions of, the Convention. Consultation and Cooperation pursuant to this article may also be undertaken through appropriate international procedures within the framework of the United Nations and in accordance with its Charter.||S&T developments can help support States Parties’ national efforts to implement the provisions of the BWC. In particular, developments in biosensors, plant and animal disease surveillance systems, and microbial forensics could contribute to monitoring and investigating potential instances of the development, acquisition, or use of a biological agent. International collaborations that help support other aspects of BWC implementation—global cooperation in scientific research, in systems for disease surveillance and identification, and in development and manufacture of vaccines and medical therapeutics—also foster transparency and contribute to the creation of conditions under which any concerns about possible risks can be discussed in a cooperative manner.|
VI. (1) Any State Party to this convention which finds that any other State Party is acting in breach of obligations deriving from the provisions of the Convention may lodge a complaint with the Security Council of the United Nations. Such a complaint should include all possible evidence confirming its validity, as well as a request for its consideration by the Security Council.
(2) Each State Party to this Convention undertakes to cooperate in carrying out any investigation which the Security Council may initiate, in accordance with the provisions of the Charter of the United Nations, on the basis of the complaint received by the Council. The Security Council shall inform the States Parties to the Convention of the results of the investigation.
|S&T can contribute to investigations of instances of alleged misuse of biological materials. Genomics and other “omics” fields provide information that can help characterize a potential agent. Creating international capacity in the field of microbial forensics, which is built on these areas of sciences, may also help identify the origins of a microbial pathogen, and this is one area of particular relevance to the BWC. Other detection and surveillance systems (e.g., biosensors, disease surveillance networks) may also help provide evidence of the occurrence of an event and assist in determining whether it is likely to be a natural outbreak, an accidental release, or an intentional act.|
|VII. Each State Party to this Convention undertakes to provide or support assistance, in accordance with the United Nations Charter, to any Party to the Convention which so requests, if the Security Council decides that such Party has been exposed to danger as a result of violation of the Convention.||S&T can contribute to the provision of assistance through the sharing of scientific information and capabilities in areas like microbial forensics, disease surveillance, vaccine development, improved treatments and prophylaxis, as well as other advances that improve biodefense and domestic response capabilities.|
|IX. Each State Party to this Convention affirms the recognized objective of effective prohibition of chemical weapons and, to this end, undertakes to continue negotiations in good faith with a view to reaching early agreement on effective measures for the prohibition of their development, production and stockpiling and for their destruction, and on appropriate measures concerning equipment and means of delivery specifically designed for the production or use of chemical agents for weapons purposes.||The use of chemical techniques to synthesize biological molecules and the use of engineered biological systems to produce chemicals highlight areas of convergence between chemistry and biology and the value of dialogue between the BWC and Chemical Weapons Convention (CWC). S&T developments discussed during the workshop (e.g., sensors, countermeasures) can also contribute to addressing potential chemical weapons threats.|
X. (1) The States Parties to this Convention undertake to facilitate, and have the right to participate in, the fullest possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes. Parties to the Convention in a position to do so shall also cooperate in contributing individually or together with other States or international organizations to the further development and application of scientific discoveries in the field of bacteriology (biology) for prevention of disease, or for other peaceful purposes.
(2) This Convention shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention or international cooperation in the field of peaceful bacteriological (biological) activities, including the international exchange of bacteriological (biological) and toxins and equipment for the processing, use or production of bacteriological (biological) agents and toxins for peaceful purposes in accordance with the provisions of the Convention.
S&T developments contribute directly to the effective use of science for peaceful and beneficial purposes. Enabling technologies such as the Internet enhance scientific collaboration and information sharing. Cooperative efforts in areas like genome sequencing, understanding human variation, vaccine development, and disease surveillance all support the goals expressed in Article X.
The scientific community can also support national and international efforts by fostering a culture of awareness, self-governance, and responsible conduct and by engaging in stakeholder discussions to achieve security goals while not unduly restricting legitimate and beneficial research.
The growing S&T capacity in many parts of the world can also enable more States Parties to participate actively in the implementation of the convention.
a In recent years the five largest (the International Gene Synthesis Consortium (IGSC), http://www.genesynthesisconsortium.org/Home.html) and a number of smaller gene synthesis companies (the International Association Synthetic Biology (IASB), http://www.ia-sb.eu/go/synthetic-biology/) have created consortia to promote adherence to different voluntary protocols to screen orders (IGSC’s emphasis) and vet customers (IASB’s) to check that transactions are legitimate. An account of this and other approaches to self-governance may be found in Smithson (2010).
SOURCE: United Nations (2011) for text of the BWC Articles.
5.3.1 Promoting Norms of Responsible
Conduct within the Scientific Community
The BWC is a formal international legal agreement, but it is also an expression of an international norm. As Ambassador Masood Khan, the chair of the BWC’s Sixth Review Conference, told the United Nations:
The BWC has had marked success in defining a clear and unambiguous global norm, completely prohibiting the acquisition and use of biological and toxin weapons under any circumstances. The preamble to the Convention so forcefully states: the use of disease as a weapon would be “repugnant to the conscience of mankind.” It captures the solemn undertaking of the states parties “never in any circumstances to develop, produce, stockpile or otherwise acquire or retain” such weapons. With 155 states parties, the treaty is not universal, but no country dares argue that biological weapons can ever have a legitimate role in national defense. Such is the force of the treaty.” (Khan, 2006)
Thus, in addition to any obligations that may fall on scientists through the legal requirements of national laws to implement the Convention, the BWC also suggests responsibilities on the part of the scientific community to help mitigate the risks that their discoveries could be misused. Two of the intersessional meetings—2005 and 2008—dealt with topics that reflect on promoting awareness and a sense of responsibility among scientists.6 Both meetings also served as major vehicles for engaging the scientific community; a number of international scientific organizations held events to prepare for and took part in the intersessional meetings themselves (NRC, 2009a, 2011a). This engagement helps encourage scientists to take part in other activities that assist with the BWC’s implementation, such as helping States Parties understand current developments in science. Efforts to engage the scientific community by emphasizing responsibilities in addition to legal requirements may also benefit from larger discussions currently taking place in various international settings about science ethics, the social responsibility of science, and specific issues related to research integrity.7
5.3.2 Monitoring and Assessing Scientific Developments
The preparations for the Seventh Review Conference have highlighted the potential for adopting a more systematic process to monitoring and assessing developments in S&T (see, for example, China, Canada, and BWC ISU  and Indonesia, Norway, and BWC ISU ). A project
6 The topic in 2005 was “content, promulgation, and adoption of codes of conduct for scientists,” and the topic in 2008 was “oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bioscience and biotechnology research with the potential of use for purposes prohibited by the convention” (Bansak, 2011).
7 Two examples of efforts that include some consideration of security issues are the 2nd World Congress on Research Integrity (http://www.wcri2010.org/index.asp) and the 2010 Draft Report on Science Ethics from the UNESCO World Commission on the Ethics of Knowledge and Technology (http://unesdoc.unesco.org/images/0018/001884/188498e.pdf).
of the Harvard Sussex Program on Chemical and Biological Weapons, “Examining the role of Science and Technology reviews in the Biological Weapons Convention,” is currently assembling an extensive list of options for taking account of S&T in the BWC’s future program.8 A detailed explanation and analysis of these options is expected to be available in the autumn of 2011 (McLeish and Revill, 2011). The committee has not attempted to duplicate the list of possible options here, but offers some general thoughts on processes that might be employed.
18.104.22.168 Employing a Formal Scientific Advisory Mechanism
As biology and chemistry increasingly interact across life sciences research, some BWC States Parties have suggested that the experiences of the CWC provide useful lessons for how the BWC could address S&T trends (China, Canada, and BWC ISU, 2010; Indonesia, Norway, and BWC ISU, 2011). The CWC includes a formal Scientific Advisory Board (SAB) appointed by the Director General of the Organization for the Prevention of Chemical Weapons (OPCW), with mechanisms for appointments, member rotation, geographical balance, and formal tasking. Substantive work within the CWC SAB is carried out at its regular meetings and also through Temporary Working Groups with formal reporting processes. Much of the SAB’s work is in developing improved verification procedures and providing S&T advice and guidance related to treaty implementation. However, such a SAB mechanism also needs institutional support (i.e., by the CWC Technical Secretariat) and has the potential to become politicized. The SAB was never intended to be the only source for reviews of S&T developments, and OPCW has found it valuable to receive input on developments in S&T from the wider scientific community. The relationship of OPCW with the International Union of Pure and Applied Chemistry described in Chapter 1, which has twice convened workshops on relevant developments in the chemical sciences and technology, reflects this broader engagement.
22.214.171.124 Making Use of Flexible Mechanisms to Address S&T
The current approach for BWC review conferences is to rely on contributions from States Parties and from experts within the relevant scientific and technical communities in a more ad hoc fashion. This approach is more flexible than appointing a formal advisory board and might more easily draw on the specific experts needed to review individual areas of
science or to answer particular scientific questions posed by the States Parties to the BWC. Another option under consideration for a future intersessional process is to create working groups or experts meetings that could be established as semi-formal arrangements between the BWC and external organizations, such as the IAP and scientific unions. The workshops in 2006 and 2010 have demonstrated the interest of these groups in the BWC and their willingness to contribute. Such groups offer potential advantages because they:
• Bring a reputation for scientific quality and independence to the discussions and provide “champions” who can act at the interface between S&T and policy communities.
• Provide access to scientists working at the cutting edge, as well as to educators, science historians, and publishers, all of whom can contribute to understanding developments.
• Provide access to scientific meetings, symposia, and journals as windows on the research community and also some access to industry.
The groups are also currently limited by budgetary constraints, minimal support staff, and organizational agendas and priorities that do not necessarily include the BWC. All four of the workshops described in Chapter 1 experienced difficulty in finding funding and staff support in time to complete their contributions to the review conference process. A somewhat more regular process for engaging the scientific community would require the provision of resources but could help ensure useful and timely contributions.
126.96.36.199 Advising Activities
Whatever sort of mechanism is selected would depend on how the States Parties define their objectives for reviewing S&T areas 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 the objectives:
• Broad Reviews of S&T Trends
At present, assessments of S&T relevant to the BWC are undertaken every five years as part of the regular review conference process. The workshops held in 2006 and 2010 reflect independent contributions from the scientific community to this process; individual States Parties and the BWC Implementation Support Unit also submit contributions on S&T. These types of workshops and contributions can provide a very broad-based overview of the state
of life sciences but are not able to delve into great detail in any one area. It has been suggested that more frequent assessments are needed, but whether they are comprehensive or focus on one or more topics of particular interest will have to be discussed and debated.
• Focused Assessments of Specific Areas of S&T
States Parties may be interested in specific areas of S&T, such as synthetic biology or microbial forensics. Activities that bring together experts in more specific fields could address developments, needs, opportunities, and implications in greater detail, or could help inform States Parties based on specific questions. New topics could be chosen yearly or on some other timeframe. Activities could include workshops, papers, and briefings of expert scientists with government technical experts or with States Parties, or other options.
Another question for States Parties to consider is how they wish to be informed about relevant S&T. As the 2006 and 2010 workshops demonstrated, scientists sometimes disagree about the state of a particular line of research, how feasible certain tasks or developments may be to accomplish, and certainly about what the potential implications of advances might be for the BWC or security more generally.9 A broad consensus may mask considerable complexity in scientific interactions. This complexity and disagreement is essential for understanding the pace and prospects for S&T developments. For policy makers, however, the messages on S&T implications may need to be presented in less complicated or more easily digestible form. This suggests an important role for government technical experts in bridging the gap between scientists from academia and industry and diplomats. The four workshops for the CWC and BWC on S&T have included technical experts for this reason and for the assistance they provide to researchers in understanding the potential implications of their work.
Discussions of a wide range of scientific and technological developments, along with their implications, are found throughout the report. This section brings together the threads of these discussions to present the committee’s overall findings and conclusions. Because of the diversity of
9 An example is the debate over the past decade about the risks posed by the publication of various research results. Some early examples of “contentious research” (Epstein, 2001) are discussed in a report from the National Research Council (2004).
research in the life sciences, the report does not cover all areas of S&T in depth. Rather, the report seeks to provide an overview of developments that the committee believes are potentially relevant to the future of the BWC, identify areas that suggest useful opportunities for further exploration and analysis, and discuss options for continued monitoring and assessing. The report is organized around three trends commonly noted in discussions of S&T: the rapid pace of life sciences developments, the increasing diffusion of research capacity, and the integration of additional disciplines beyond biology in current life sciences research.
Pace of S&T Developments
As was clear from the workshop presentations and discussions, life sciences research continues to advance rapidly and is expected to do so for the foreseeable future. Research in areas such as omics, systems biology, immunology, neuroscience, and many other fields is improving the understanding of complex biological processes. At the same time, the power and availability of many of the enabling technologies that support life sciences research continue to grow.
Diffusion of Research Capacity
The workshop highlighted global research capacity and the growing number of international collaborations in S&T. Examples in areas such as disease surveillance and microbial forensics provide clear illustrations of how international collaboration can support the BWC’s goals. The engagement of students in hands-on research through efforts like the International Genetically Engineered Machine competition (iGEM) and the expanding interest in do-it-yourself biology represent yet other forms of this diffusion. The report considers several factors that may enhance or impede developments in relevant areas of S&T and the continuing spread of research capacity, while noting the value of efforts to continue assessing and understanding the implications of these for the BWC.
Integration of Life Sciences with Other Disciplines
Life sciences research draws on the expertise not only of biologists but increasingly also on scientists from multiple disciplines in the physical sciences, engineering, and computational sciences. As a result, efforts to monitor and assess S&T developments draw on a growing range of expertise. The scientific community may have roles to play as part of this process, for example by exploring and clarifying scientific issues in areas of overlap between chemistry and biology that might have potential implications for the BWC and CWC.
The committee reached the following nine findings:
Finding 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.
Finding II: There has been particularly rapid progress in the power of, and access to, enabling technologies, especially those depending upon increased computing power. These include high throughput laboratory technologies and computational and communication resources. This has the following consequences:
• Collaborations between individual investigators, global networks of researchers, and the formation of “virtual laboratories” are growing trends in the life sciences.
• Increasing access to sophisticated reagents such as standardized DNA “parts” and easy-to-use commercial kits and services has placed some hitherto advanced technologies within the reach of less highly trained practitioners, and has expanded the global spread of life sciences research and its industrial applications.
• Although first class research continues to rely heavily upon tacit knowledge, 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.
• These technologies reduce the barriers to the spread of S&T knowledge for responsible, educational purposes, thus creating more favorable conditions for international cooperation in the peaceful application of the life sciences.
• At the same time, we must recognize that these same barriers also serve 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.
Finding III: Multiple disciplines, including the life, chemical, physical, mathematical, 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.
Finding IV: The field of bioreactor research and the use of transgenic organisms to produce commercially or medically important proteins have seen impressive 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.
Finding V: The development of microbial forensics illustrates one way that life sciences research from around the world can support the BWC and create better tools to investigate and discriminate between natural and deliberate disease outbreaks.
Finding VI: Notable technical advances have been made at the level of individual-use biosensor detector systems, although there are limitations to what can be achieved given that sensor development must balance factors such as specificity, sensitivity, range of target molecules analyzed, and type of use.
Finding VII: The combination of approaches including improved biosensors, epidemiological monitoring, vaccine research, forensics, and other laboratory investigations can contribute to effective disease detection, investigation, and response systems worldwide.
Finding VIII: These advances underscore the potential for more States Parties to contribute 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.
Finding IX: Certain scientific and technical roadblocks (e.g., drug delivery technologies) 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.
Many of the committee’s findings about developments 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 currently 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.
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 organization 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 developments 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 functions 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.