5
Models for Managing Change

In a special feature on the 2004 U.S. presidential election, the journal Nature published statements by both candidates regarding the gradual dissemination of knowledge about bioweapons (and other “weapons of mass destruction”). In his response, President Bush correctly and very importantly acknowledged that “stopping the gradual dissemination of knowledge is impractical if not impossible.” But then he claimed that the “the key to stopping the proliferation of weapons of mass destruction is preventing those seeking these weapons from gaining access to their most significant and technically challenging components.”1 The notion that limiting access would be an effective strategy for controlling widely disseminated “dual-use” technologies may not appreciate fully the complexity of the “problem.” If it were possible to gain such tight control, emerging infectious diseases (i.e., naturally occurring outbreaks and epidemics) would not be on the global public health agenda.

But if limiting access is not the solution, what is? What can and should be done? How can scientific knowledge, dual-use biological agents, equipment, and technology be managed such that invoked strategies do not hamper the growth of scientific knowledge and the global spread of beneficial advancing technologies?

This chapter provides a summary of the workshop presentations and discussions that revolved around control strategies currently being used

1  

Macilwain, C. 2004. “Head to head.” Nature 431:239-243.



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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop 5 Models for Managing Change In a special feature on the 2004 U.S. presidential election, the journal Nature published statements by both candidates regarding the gradual dissemination of knowledge about bioweapons (and other “weapons of mass destruction”). In his response, President Bush correctly and very importantly acknowledged that “stopping the gradual dissemination of knowledge is impractical if not impossible.” But then he claimed that the “the key to stopping the proliferation of weapons of mass destruction is preventing those seeking these weapons from gaining access to their most significant and technically challenging components.”1 The notion that limiting access would be an effective strategy for controlling widely disseminated “dual-use” technologies may not appreciate fully the complexity of the “problem.” If it were possible to gain such tight control, emerging infectious diseases (i.e., naturally occurring outbreaks and epidemics) would not be on the global public health agenda. But if limiting access is not the solution, what is? What can and should be done? How can scientific knowledge, dual-use biological agents, equipment, and technology be managed such that invoked strategies do not hamper the growth of scientific knowledge and the global spread of beneficial advancing technologies? This chapter provides a summary of the workshop presentations and discussions that revolved around control strategies currently being used 1   Macilwain, C. 2004. “Head to head.” Nature 431:239-243.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop or pursued worldwide with respect to the dual-use risk posed by extant, emerging, and converging technologies. These strategies can be roughly categorized as one of three types: formal (e.g., state-level arms control agreements, including the Biological and Toxin Weapons Convention, or BWC); limited-membership consensus (e.g., the non-binding Australia Group export control program); and informal (e.g., codes of conduct for scientists). Two important themes emerged from the lengthy dialogue on these various strategic approaches. First, several workshop speakers commented that no single approach will likely be effective by itself. For example, during the discussion on challenges faced by the BWC follow-up process (i.e., annual meetings being conducted as a lead-up to the 2006 Review Conference), it was emphasized that there is a danger in being too restrictive with regards to believing in the omnipotence of any single tool. The workshop participants also suggested that there is a natural tendency to overemphasize the potential contribution of formal arms control. However, the BWC is not the only tool available for managing the dual-use risk of advancing technologies. Second, some workshop speakers emphasized that proposed solutions were dependent upon how one defined the dual-use problem and identified risks. This point is illustrated by the difference in perceptions between Singapore and the United States as to whether the bacterium Burkholderia pseudomallei constitutes a risk. As discussed in previous chapters, B. pseudomallei is on the U.S. select agent list because of its dual-use potential. However, in Singapore, where the bacterium is an endemic soil microorganism, it is viewed as a source of naturally occurring disease. The controversy surrounding the lack of a compliance and verification protocol to the BWC was mentioned several times during the workshop. An important theme to emerge from these discussions is that there are many non-verification related components of the BWC, as well a broad range of non-BWC efforts and accomplishments, that might play important roles in building and strengthening a global effort to minimize the dual-use risks posed by the rapid progress and proliferation of technological knowledge, technology, and materials. A comment was made that even if the BWC compliance and verification protocol had been adopted several years ago, it would not have been sufficient. Given the nature of the threat, particularly the constantly changing and unpredictable future of the global biotechnology landscape, a successful biological weapons control regime will undoubtedly involve a multi-dimensional approach comprising multiple components.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop ARMS CONTROL2 For the past century, the United States has historically been one of the world’s leaders in establishing and promoting norms and regimes to limit the proliferation of nuclear, chemical, and biological weapons and missiles. A “regime” comprises the multitude of cooperative and coercive measures—including international agreements, multilateral organizations, national laws, regulations, and policies—intended to prevent the spread of dangerous weapons and technologies. The fundamental purpose of developing and strengthening any weapons regime is to establish a clear sense of legitimate behavior by virtue of implicit and explicit rules, regulations, and norms. This section summarizes the workshop presentations and discussions that focused on the role of formal arms control measures in managing the dual-use risk of advancing technologies and lessons to be learned from the nuclear and chemical regimes. The Biological Regime3 The biological weapons regime dates back to the 1925 Geneva Protocol, which entered into force in 1928. The Protocol, which was supported by one of the most outspoken and ferocious public appeals the International Committee of the Red Cross has ever made, was drafted in response to the horrific consequences of the extensive use of gas in World War I. It prohibits the wartime use of “asphyxiating, poisonous, or other gases, and of all analogous liquids, materials, or devices” and of “bacteriological methods of warfare.” The most important international step taken to strengthen the biological weapons regime occurred decades later, with the 1972 Biological and Toxin Weapons Convention (BWC), which entered into force in 1975. The BWC prohibits the development, production, stockpiling, or acquisition of biological agents or toxins of any type or quantity that do not have protective, medical, or other peaceful purposes, or any weapons or means of delivery for such agents or toxins. According to the treaty, all such material must be destroyed within nine months of entry into force. As of 2002, there were 164 signatories and 146 ratifying and acceding countries.4 Although much of the workshop dialogue surrounding problems and gaps in the BWC tended to revolve around its lack of a compliance and verification protocol (which is discussed in detail below), some speakers 2   This section is based on the workshop presentations of Tibor Toth, Robert Mathewa, and Amy Sands and lengthy discussion among workshop participants. 3   Based on presentations by Tibor Toth and Amy Sands and comments by many individuals. 4   http://www.stimson.org/cbw/?sn=CB2001121271. Accessed on November 16, 2004.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop and discussants argued that resolving the verification controversy is not necessary for moving forward in other areas and should not be used as an excuse not to take steps that can thwart or minimize the threat of biological terrorism. Challenges to the Biological Regime5 Despite its relatively long history, beginning with the Geneva Protocol, the biological weapons regime and the BWC in particular are fraught with challenge. This section summarizes the nature of some of these challenges, as discussed during the workshop. Recent history of the BWC Several events in the 1990s created an incentive to strengthen the biological weapons prohibition regime. These included the acknowledgment of past bioweapons programs by the former Soviet Union and South Africa; growing suspicions of ongoing bioweapons programs in Iraq and a number of other states; a wave of non-biological terrorist attacks in the mid-1990s, including the Oklahoma bombing and Tokyo sarin attack; and widespread concern that rapidly advancing technological developments were paving the way for the easy means to create and produce novel bioweapons. Although the dangerous reality of non-state bioterrorism has thus far resulted in only limited casualties, it has had a terrible psychological impact. In the one and half months following the 2001 anthrax mailings, which led to 5 deaths and 17 other cases of disease in the United States, there were 10,000 hoaxes, each of which stirred public concern, cost money, and diverted resources and attention away from equally compelling, competing problems. More than U.S. $100 million was spent on the emergency during those first one and a half months, and the complete clean-up and modification of the U.S. postal system is expected to cost more than $5 billion. The anthrax attack demonstrated the blatant breaking of deliberate use rules which had been in place for more than seven decades. That same year, the BWC and all that it entailed, including its annual review conferences and confidence-building measures and negotiations, came under attack. Compliance and verification negotiations, which had been underway since 1995, were suspended, the Fifth Review Conference was postponed (after the United States proposed to terminate the Ad Hoc Group in charge of negotiating a verification protocol to the Convention), and general widespread doubts about BWC compliance were articulated. 5   Based on comments by T. Toth and A. Sands, and comments by many individuals.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop Not only did the BWC fail to adopt a verification protocol, but states parties were also unable to agree on a routine reaffirmation of the objectives, principles, and norms as they had done in every other review conference. Between December 2001 and September 2002, there was a danger of completely shutting down the entire review process until 2006. But in November 2002, a Fifth Review Conference was successfully completed and a follow-up process of activities established as a lead-up to the Sixth Review Conference in 2006. Opportunities and challenges of the BWC follow-up process The BWC follow-up process involves three weeks of meetings per year (i.e., two weeks with experts, one week with States parties) and does not (or will not) produce any legally binding documents. The focus is on five discrete sets of BWC issues, all of which play a direct role in the “health” of the prohibition regime and, importantly, none of which are directly related to treaty compliance: national implementation, biosecurity, disease control, the investigation of deliberate disease, and codes of conduct (see Box 5-1). Thus far, the follow-up process has accomplished several major achievements: There has been a wide exchange of information about activities undertaken by intergovernmental organizations, states parties, and non-State actors. In the past, review conferences have not generally been a useful forum for undertaking such exchange, since they usually focused on drafting provisions about general implementation aspects of the Convention. Moreover, past provisions have been quite generic with respect to the future direction of the activities of states parties. This new widespread exchange of information has led to a greater sharing of best practices with regards to national implementation of disease control and deliberate disease investigation. In 2004, there were about 200 presentations on this topic. The follow-up process provides a forum where countries can identify mutual interests in undertaking corporation-level biomolecular projects, while simultaneously offering a forum for consolidating perspectives. The large number of proposals in 2003 (200 discrete proposals, clustered into 55 groups) and in 2004 (more than 400 proposals, which have yet to be clustered) demonstrate a strong interest by States parties in promoting cooperation in relevant areas. The proposals represent ideas that could readily be converted into executable projects with the necessary budget and infrastructural support.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop BOX 5-1 Areas of BWC Follow-up Process 2003: the adoption of necessary national measures to implement the prohibitions set forth in the Convention, including the enactment of penal legislation 2003: national mechanisms to establish and maintain the security and oversight of pathogenic microorganisms and toxins 2004: enhancing international capabilities for responding to, investigating, and mitigating the effects of cases of alleged use of biological or toxin weapons or suspicious outbreaks of disease 2004: strengthening and broadening national and international institutional efforts and existing mechanisms for the surveillance, detection, diagnosis, and combating of infectious diseases affecting humans, animals, and plants 2005: the content, promulgation, and adoption of codes of conduct for scientists NOTE: Adapted from Tibor Toth’s PowerPoint presentation, September 22, 2004. The 2004 forum was the largest multidisciplinary meeting of the topic under discussion, with about 5000 persons participating and 90 States parties represented. These numbers exceed the attendance numbers at review conferences, including the number of decision-making delegates. However, the follow-up process and, ultimately, the 2006 Sixth Review Conference and BWC still face many important challenges (i.e., verification issues aside). Perhaps most importantly, there is a certain danger in being selective. This selectivity dilemma exists on several levels. First, there may be a danger in selecting one tool—in this case, the BWC—among the many in the toolbox against deliberate disease. For example, within the disarmament constituency, there is a natural tendency to overemphasize the potential contribution of arms control in addressing this threat. In fact, historically, over the past 30 to 40 years, every few years the “flavor” of the period changes, believing in the omnipotence of one or another tool, whether it be the BWC or something else, and ignoring the synergy that results when multiple tools are combined and used appropriately (see Figure 5-1). The question then becomes, under what conditions should certain tools be used?

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop FIGURE 5-1 Weapons of mass destruction toolbox. Within the disarmament constituency, there is a natural tendency to overemphasize the potential contribution of arms control in addressing the dual-use risk of advancing technologies. This chart represents the reality that, for all weapons regimes, disarmament is only one of many tools available. NOTE: Adapted from Tibor Toth’s PowerPoint presentation, September 22, 2004. Second, just as “solving” the dual-use risk of advancing technologies of biotechnology will require developing and relying on a multitude of tools (the BWC being one of them), strengthening the BWC itself will require developing and ultimately relying on several components. Many countries may be suffering from “verification fatigue,” not just because of the BWC controversy but also because of past experience with the intrusive verification protocol of the CWC. But it would be dangerous to put all of one’s eggs into the follow-up process and ignore verification. Likewise, it would be dangerous to ignore the potential of the follow-up process and attempt to put all of one’s eggs into verification (or another basket). There are lessons to be learned about the verification protocol process and how, to some extent, there was a sense of complacency while

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop the negotiations were occurring and a sense that the arms control experts in Geneva would solve the problem. Meanwhile, the problem became more complicated and is still complicated, with no protocol in hand. Extreme thinking on either end would pose a significant challenge to the 2006 Review Conference. A third selectivity dilemma arises from the multiple participatory levels in the BWC (i.e, global, multilateral, national, regional, local, etc.) and questions that arise over who should implement what. There is often a tendency to underestimate or deny the positive contributions that global interstate cooperation could make. On the other hand, there might be a tendency to ignore the extremely important efforts that regional, local, or multilateral parties make. Fourth, by considering biological weapons as weapons of mass destruction, comparable to nuclear, chemical, and radiological weapons, there is a danger in ignoring bioweapons—the “Cinderella” of weapons of mass destruction—and their true threat in both absolute and relative terms. A second major challenge to the BWC, despite early achievements of the follow-up process, is the dilemma between what is necessary and what is feasible. As President Kennedy once said, “Whatever is logical is not realistic and whatever is realistic is not logical.” Although the BWC follow-up process was deemed feasible, in light of the difficulties and controversy surrounding verification at the 2001 Fifth Review Conference and as a lead-up to the 2006 Review Conference, urgent action will be needed beyond 2006. This dilemma will only be solved when the absolute and relative dangers of biological weapons (i.e., relative with respect to nuclear, chemical, and radiological weapons) are realized. Table 5-1 summarizes the differences among these classes of weapons, with respect to weapons characteristics, requirements for weapons production, and sources of diversion. Not only are biological weapons different than other weapons of mass destruction, they are more destructive than they have generally been perceived to be in the past. Steps that will need to be taken beyond 2006, in order to strengthen the BWC once the follow-up process is complete: making the BWC process more sustainable than the 5 to 10 year length of most political cycles (e.g., by identifying sustainable activities); building upon the achievements of the follow-up process by moving from what is feasible to what is needed; acting, as opposed to producing provisions; assisting in the five areas (of the follow-up process) beyond the bilateral framework (as disease and biosecurity will not respect this limited level of cooperation);

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop deepening and widening cooperation between IGOs without endangering their core mission; and consolidating the mechanism of interaction between States Parties. Feasible steps that could be taken now include: consolidate what has been achieved in the new BWC follow-up process so far; assist in further national implementation efforts; promote implementation-related assistance between interested countries; and raise awareness about on-going activities and further needs outside the BWC framework. Non-state actors There is serious concern about whether and how the BWC thwarts or (if strengthened) could thwart or minimize the growing threat of non-state terrorist use of dual-use agents and technology. As one participant said, “arms control really has to be relabeled as ‘counter-terrorism’ because that, in effect, is what’s happening, whether we like it or not.” In light of this, although the BWC accommodates counter-terrorism activities to some extent, one of the major challenges it faces is translating the internationally agreed prohibitions into effective domestic enforcement. In response, it was argued that all five areas of focus for the BWC follow-up process offer possible spin-offs that address non-state terrorist scenarios. In fact, in most BWC discussions over the past 10 years or so, this issue has figured prominently, in terms of both conceptualizing the threats and addressing the problems. It is widely realized that, with regards to national implementation of the BWC, the stronger the national mechanisms (e.g., legal, bureaucratic, etc.), the lesser the potential for misuse of the technology. With regards to disease control and investigation, the need to create a system with the shortest lead time possible and one with the capacity to differentiate natural from deliberate occurrences will strengthen biodefense against state and non-state actors alike. Moreover, articles III and IV of the BWC clearly refer to non-state terrorist groups as well as state actors. Article III creates a very clear obligation not to transfer to any recipient whatsoever any sort of material, equipment, or know-how for making biological weapons: Each State Party to this Convention undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins,

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop   TABLE 5-1 Biological Weapons Weapons Characteristics NW CW BW RW (Dirty Bomb/NF Release) Destruction = 100,000 p =10,000 p =100,000 p =1,000 p or =10,000 p Time seconds =sec/hours =hours/weeks =months/years Area =10 km2 =1 km2 =10 km2 =1 km2 or =1,000 km2 Quantity/Size =1,000 kg (12.5 kt) =1,000 kg (sarin) =100 kg (anthrax) =1,000 kg Manifestation Clear No manifestation during delivery No manifestation during delivery Clear (prior radioactivity) Delivery Bomb Aerosol, liquid, or solid Aerosol, liquid, solid, other Bomb release from facility Diversion Requirements NW CW BW RW Lead Time =10 years =1 year =1 month =1 year or more Size of Effort = 10 km2 (multiple facilities) = 1 km2 =100 m2 = 100 m2 Manpower =100 p =10 p =1 p =1 p or more Financing =$1,000,000,000 =$1,000,000 =$10,000 =$10,000 or more Know-how = Ph.D. =Ph.D. =Ph.D. =Ph.D.  

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop   Diversion Sources (present) NW CW BW RW Weapons =10 states = 10,000 warheads =1,000 storage sites =10 states =10 locations =100,000 t = 10,000,000 munitions = 10 states =10,000 t = 1,000 t Facilities =1,000 =10,000 = 100 biodefense =10,000 industry =1,000 to 100,000 Agents/Materials =1 =10 =100 =10 Experts =1,000,000 =10,000 CWC =10,000 industrial =10,000 BWC =10,000 industrial =1,000 Diversion Sources (2015) NW CW BW RW Weapons =10 states =10,000 warhead = 10 states = 1,000 t = 10 states =10,000 t   Facilities = 1,000 = 10,000 = 10,000 (=10% increase) =100,000 =1,000 Agents/Materials =1 =10 =1,000 =10 Experts =1,000 =10,000 CWC = 10,000 industrial (=1% increase) = 10,000 BWC = 100,000 industrial (=10% increase) = 1,000 NOTE: Adapted from Tibor Toth’s PowerPoint presentation, September 22, 2004.  

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop The draft ICGEB code of conduct will be based on several principles: The code will be based on scientific deontology, addressed to the individual conscience of the scientist (i.e., with no juridicial implications). Focus will be on the individual responsibility of the scientist and on the principle that ethical values shall overcome hierarchy. In contrast to nuclear research programs, which require much larger set-ups, life scientists should have under their control the complete procedure related to the potential misuse of the experiment. The code will not provide a definition of permissible or forbidden experiments, rather the concept of acceptable versus unacceptable intents of research. The code should not be aimed at establishing the principle of self-censorship but should serve as an example of self-governance by the scientific community. A question was raised about the third component listed above and whether a researcher can ever really have a complete vision of the scope of an experiment, from beginning to end, given the fact that so many advances in the life sciences result from unpredictable multidisciplinary interactions. But flying a plane into a building is not a highly technological accomplishment and yet is made possible by other incredibly beneficial accomplishments. It is very difficult for scientists to anticipate how their technologies might be used. Thus the question, how can and will this code of conduct encompass these unforeseen trajectories? One workshop participant questioned whether ICGEB anticipates any sort of international educational program to disseminate the code and integrate it into scientist training programs. In response, it was pointed out that, at least as far as the ICGEB is concerned, the code would likely become a compulsory document for all scientists who even remotely come into contact with ICGEB activities. There was a question about why industry is not currently represented on the ICGEB code of conduct committee. In response, it was noted that the inclusion of industry was viewed as being too complicated at the very beginning of this process; once a straw-person code of conduct has been developed, then industry might be involved in later stages. There are concerns that not involving the private sector early on could seriously hinder further progress down the line. IISS/CBACI charter In contrast to the ICGEB code, the code (or charter) drafted by the International Institute for Strategic Studies (IISS) and the Chemical and

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop Biological Arms Control Institute (CBACI) has relied on extensive consultation with the private sector as well as academia and government. This charter is one of several building blocks that the IISS and CBACI considers important in promoting what it calls a “culture of responsibility.” Other building blocks include an analysis of developments in the life sciences; epidemiological surveillance; and an international leadership forum for young life scientists working in academia, the private sector, and government organizations. A “culture of responsibility” would support an independent International Centre for the Life Sciences (ICLS) and a specific mandate to focus on a safety and security agenda; and it would bring together scientists, technologists, and policy experts in the life sciences and encourage partnerships between private foundations and independent research institutes. The CBACI and IISS charter covers five categories: International and national laws and regulations: “Observe, promote and cooperate to help develop effective national and international laws and regulations in relation to the life sciences.” Personnel: “Exercise the highest standards in the recruitment, training and management of personnel during and after employment, with special attention to those with access to information, materials and technology that could directly affect public safety and security if misused or not operated safely and appropriately.” Information: “Ensure the security of information by observing the relevant international and national laws and regulations in the handling of information that could have a negative impact on public safety and security; and also to contribute to developing, in cooperation with governments, the academic community and commercial sector as appropriate, effective and responsible procedures for the release of such information into the public domain.” Safe and secure operation of facilities: “Observe the highest possible standards for the safe and secure operation of all facilities in the interest of public and environmental safety; and to contribute to the development of more effective international and national laws, regulations, guidelines, and standards in this regard.” Governance of research and development activities: “Take full account of security, safety and ethical concerns when planning and conducting research and development activities and to support and contribute to effective and responsible international and national entities engaged in developing and promoting codes of conduct in this regard.” IISS’s vision for an International Centre for the Life Sciences (ICLS) is of a center that operates independently; has a supervisory board of inter-

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop nationally recognized and highly regarded experts; operates with a small number of highly qualified staff; supports a range of activities, such as annual forums, projects, workshops, and information exchange; and serves as the hub of an international network of organizations, institutions, and individuals. It is believed that an ICLS could be a vital contribution to biological safety and security. Awareness-Raising and Education of Scientists20 As mentioned previously, given the widespread preconceptions about the BWC, its history, the controversy over verification, and indeed its very existence, there seems to be a need for some sort of BWC education program for life scientists. In fact, it was argued that awareness-raising and education may be more valuable than an established code of conduct, particularly if it encompasses not just ethical but also legal norms with regards to dual-use agents, information, and technology. Many scientists are not aware that the BWC applies to both states and individuals and that any individual who engages in the development, production, and stockpiling of biological weapons is subject to criminal legislation. Awareness-raising could occur formally or informally. It would seem relatively straightforward to incorporate the concept of dual-use into the formal training in research ethics that National Institutes of Health (NIH) postdoctoral trainees, for example, are required to undergo. Most bioethics courses focus on human and animal experimental use and other non dual-use issues. Dual-use educational efforts could also be integrated into continuing education courses, licensure courses, or other regular sets of activities such that anybody in the field would be expected to be updated with respect to dual-use risks. It would be important not to normalize the requirement to the extent where it involves simply checking a box. Awareness-raising could also be integrated into other, less formal activities, such as mentoring and role-modeling by leaders in the field. This points to the need for more scientists to become involved in the dual-use challenge by speaking out and assuming leadership roles, rather than waiting or relying on government or industry to take charge. Research Oversight21 The notion of dangerous research, whether it be immune system evasion research or molecular biology research in general, does not neces- 20   Based on multiple workshop participant comments. 21   Based on multiple workshop participant comments.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop sarily imply that prohibitive actions be taken, as it would be counter-productive to do so. Rather, it points to the need for some sort of oversight, perhaps something along the lines of what has been suggested in the recent National Research Council report Biotechnology Research in an Age of Terrorism.22 One of the recommended measures is the recognition by the scientific community that they must pay greater attention to the potential misuse of their research.23 However, even full implementation of this and other recommended measures would leave significant gaps, for example among private laboratories not federally funded and not subject to the federal system of review. At the same time, open-ended or vague definitions for “experiments of concern” will subject vast components of the research enterprise (e.g., in microbial pathogenesis) to unnecessary and counter-productive review. It was also suggested that lessons might be learned from South Africa, where research applications that involve dual-use technology must pass through a first stage of review by a non-proliferation counsel before they can be authorized; the process has been very effective and has resulted in a number of arrests over the years. The purpose of oversight is to instill transparency such that flagged research projects (i.e., flagged by a review committee) create an entirely different level of awareness. As an example of how this might play out, if the Australian scientists who accidentally created a lethal mousepox virus had foreseen some of the consequences of their research (i.e., the effect that IL-4 would have in this model system), or if a review committee had foreseen the consequences, the researchers could have taken a different route to seek the answers they sought. In the United States, just as NIH review committees are obliged to consider work on human subjects and work on animals, they could be obliged to consider dual-use threats. Along the same lines, editors of scientific journals could add an extra layer of oversight during manuscript review. Eventually, some sort of licensing process may be necessary, whereby investigators receive their research license only after meeting certain BWC and ethical decision-making instruction requirements. One participant questioned whether scientists working with dangerous pathogens or dual-use materials or information should be registered. Even hairdressers in most countries must be licensed, so why not scientists who are dealing with dangerous research? In countries with transparent 22   National Research Council. 2004. Biotechnology Research in an Age of Terrorism. Washington, D.C.: The National Academies Press. 23   Chyba, C. F. and A. L. Greninger. 2004. “Biotechnology and bioterrorism: an unprecedented world” Survival 46:143-162.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop registries, this could pose a problem (e.g., UK researchers conducting animal experimentation would not want their names available to the public). In the United States, registration and transparency are not currently linked. A potential problem could arise if registration required of certain sectors (i.e., industry and academia) was not required of others (i.e., governmental biodefense researchers), as exempting the latter would raise suspicions about government activity and intent. Perhaps the greatest challenge would be identifying what qualifies as “dangerous.” Although oversight could be feasible at the national level, a question was raised about how it would be negotiated internationally. Because not all countries, including those of greatest concern, have the capacity to establish comparable oversight systems, one possibility might be a global system of internationally agreed rules for the oversight of high-consequence biological research.24 Challenges to this approach include global implementation (how would such a system be effectively and widely implemented?); the capability, or lack thereof, to identify and stop groups or persons who are not following the rules (although it is believed that most non-state terrorist groups are unlikely to carry out sophisticated research themselves—rather they will track the scientific literature, in which case high-consequence work can be overseen); and complications associated with identifying “high-consequence research.”25 The Role of Industry26 Questions were raised about the role of the pharmaceutical and biotech industries in mitigating the risk of dual-use biological materials, as there has been a blatant lack of involvement by the life sciences industry in the dual-use debate. The ICRC has made a number of efforts to include industry in discussions of these issues, but it has been very difficult to make any sort of connection. As an example of the current lack of awareness among experts outside of the defense sector, a story was told about a bioterrorism panel discussion at an international toxicology meeting several years ago. The audience was comprised largely of pharmaceutical and biotech industry professionals, whose attitude was along the lines of “why are we talking about this?” 24   Steinbruner, J. et al. 2003. “Controlling Dangerous Pathogens: A Prototype Protective Oversight System.” September. http://www.cissm.umd.edu/documents/pathogensmonograph.pdf. Accessed on October 18, 2004. 25   Chyba, C. F. and A. L. Greninger, 2004. “Biotechnology and bioterrorism: an unprecedented world.” Survival 46:143-162. 26   Based on workshop discussion; multiple comments.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop It was noted that many companies seem to paint a rosy picture of the ultimate use of their products and the knowledge generated, without much concern for potential risks and the need to examine those risks in advance of the proliferation of the products and knowledge. Considering that every scientific revolution has been put to hostile use, believing or pretending that hostile consequences will not result in the absence of preventative measures almost constitutes intentional naiveté and practically defies history. Given that the pharmaceutical industry is the most highly regulated industry in the world with a lengthy production process, it is not surprising that it is difficult to generate interest in these public concerns. Industry, for the most part and rightly so, looks after its own commercial strategic interests. However, would it not be in the pharmaceutical industry’s best strategic interest to respond to public anxiety and concerns, whether those concerns be about biodefense, public health safety, or other threats? This complacency may be changing in response to the changing security climate. The private sector has recently expressed greater interest in engaging on this front. But who will be first? Is it not in each company’s best interest to sit back and wait for another company to take the initiative? It was suggested that, since biotech companies are driven largely by innovation, U.S. biodefense spending (i.e., BioShield27) should represent the type of innovation initiative that attracts these companies. It would be interesting to hear from the biotech industry about whether and how it could take advantage of opportunities afforded by the governmental allocation of funds to biodefense in ways that would be useful not just for biodefense but also would serve the companies’ own internal needs. Rather than expecting industry to step forward now, perhaps a more immediate challenge is to mobilize the public and government in order to create a context in which industry can take its cue. It seems that commitment to the idea that industry may have something to gain from being involved needs to be built on a broader front, that is by engaging industry, academia, government, and military sectors in a common interest, with the understanding that industry is as much a part of the solution as anyone else. Approaching the problem from this presumably more feasible and realistic stance represents the building block approach that a global response to the dual-use dilemma is going to require. Rather than waiting for industry to wake up, efforts should be directed toward moving what can be moved in ways that will catalyze others and accelerate the process. 27   Project BioShield Act of 2004 (S.15, HR 2122). Signed by President Bush on July 21, 2004. PL 108-276.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop The World Association of Nuclear Operators was cited as a successful private endeavor to improve nuclear plant operational safety,28 which is a notable achievement for a private enterprise given the political barriers in the nuclear field. It represents the type of private sector self-regulation that, according to one participant, will likely (or should) play a hugely important role in managing the dual-use risk of advancing technologies. Risk Assessment29 It was emphasized that any proposed strategy must avoid promulgating the notion that “science is dangerous,” given the enormous untold benefits of technological progress, while also recognizing the risks associated with the dissemination of scientific knowledge and dual-use biological agents, materials, and technology. This raises the fundamental question, what are those risks? The question is made more complicated by the fact that, as new sciences and technologies emerge, so too do new risks. It is further complicated by the reality that one’s perception of risk changes, depending on how and where in the world one lives and works (e.g., a U.S. defense official would probably perceive certain risks differently than a Singaporean epidemiologist). In order to move forward, common ground must be sought among the diversity of threat perceptions. There is disagreement about which agents are or should be considered dangerous, and questions have been raised about whether the recent U.S. governmental decisions regarding dual-use risks (i.e., the Select Agent Rules and Regulations) and the allocation of biodefense resources (i.e., Project BioShield, which was signed into law in July 200430) may be misguided. It was noted how the number of media references to smallpox changed leading up to, during, and after the Iraq war, despite the lack of any objective measure of the risk whatsoever.31 There was some discussion about whether current efforts run the danger of being too “pathogenocentric” and whether enough focus has been directed toward non-pathogenic agents, let alone dual-use equipment and delivery and dissemination technologies. On the other hand, too many measures may constrain or dissuade beneficial biomedical research and the capacity to respond to a global infectious disease emergency. 28   Available at http://www.wano.org.uk. 29   Based on discussion and multiple comments. 30   Available at http://www.whitehouse.gov/bioshield. Accessed on October 23, 2004. 31   Cohen, H. W. et al. 2004. “The pitfalls of bioterrorism preparedness: the anthrax and smallpox experiences.” American Journal of Public Health 94:1667-1671.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop It was suggested that it would be prudent to have at least some minimal level of objective risk assessment in place before actions are taken, not only to prevent misguided national-level decisions but in order to strengthen the critically important international component of dual-use management. As it currently stands now, varying assessments of risk hamper international cooperation. One participant emphasized that sorting through the diversity of risk perceptions in order to establish an objective, usable framework for action will require the involvement of the scientific community. Because of their first-hand knowledge and experience, scientists need to publicly articulate what the risks are, what preventative measures can be taken, and what policies should be put in place. Another participant commented that risk analyses should involve assessing the entire spectrum of risks, from naturally occurring pandemics to deliberate use. If risk analyses and biodefense/public health preparedness measures fail to consider all possible risks, then it will be very difficult to recruit the type of multi-disciplinary participation that effective biotechnology dual-use management will require further down the line. It was noted that it may be impossible to identify all the risks, given that the plethora of possibilities practically defies definition and that new risks will continually emerge. The Human Security Lens32 It was suggested that it might be helpful to view the dual-use dilemma through a human security lens by asking the question, does the application advance human security? The concept of human security was developed decades ago, in the United Nations Development Programme’s 1949 Human Development Report.33 More recently, in its 2003 report, Human Security Now, the Commission on Human Security, an initiative of the Government of Japan, proposed that a human security framework be used for enhancing and redirecting policies and institutions to address 21st century conditions and threats, including terrorism.34 Most importantly, human security is about people, not states, which makes it very different from the military framework that state and national security operate within. Efforts to strengthen biodefense, clean up the environment, reduce hunger, reduce poverty, and improve human health all lie within the 32   Based on the presentation by Abdullah Daar. 33   United Nations Development Programme. 1949. Human Development Report. 34   Available at http://www.humansecurity-chs.org/finalreport/FinalReport.pdf. Accessed on January 4, 2005.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop “human security” framework. As outlined during the workshop, human security is: shielding people from critical and pervasive threats and empowering them to take charge of their lives; protecting the vital core of all human lives in ways that enhance human freedoms and human fulfillment; protecting fundamental freedoms that are the essence of life; protecting people from critical (severe) and pervasive (widespread) threats and situations; using processes that build on people’s strengths and aspirations; and creating political, social, environmental, economic, military, and cultural systems that together give people the building blocks of survival, livelihood, and dignity. Viewing the dual-use dilemma through a human security lens, for example as the Global Genomics Initiative does, provides what one participant described as a “meta-guiding principle” for balancing the benefits and risks of advancing technologies. It was suggested that only those scientific and technological applications that advance human security be encouraged. On the other hand, it was argued that the very difficult question remains: does the application pose a threat? The most beneficial science could, in principle, also be (or become) the most dangerous. Possible Approaches to Balancing the Benefits and Risks of Advancing Technologies35 Emerging biotechnology trends have the tremendous potential to strengthen the social and economic development of all countries, improve the health and quality of life for billions of people, and alleviate the growing economic and health disparities between industrialized nations and their low- and middle-income neighbors. Technologies once affordable only to the wealthiest nations, including genomics-based applications and pharmaceutical and vaccine manufacturing, have expanded globally. From Mexico to Singapore to South Africa, the world is unabashedly embracing technological growth in the name of national sovereignty, national security, economic growth, and improved health care for all. However, this extraordinary potential creates a challenge with respect to dual-use threats. The challenge is expected to magnify over time, as the 35   Based on comments by many participants.

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop global proliferation and progress of biotechnology continue to accelerate. No amount of national or international legislation, regulation, or control can eliminate the proliferation of dual-use agents, knowledge, and technology. Thus the question, what can be done? The purpose of this workshop was to gather information on the international nature of the dual-use risks of advancing technologies, not formulate conclusions or recommendations for next steps. However, many participants voiced their opinions with regards to how, on a very general level, challenges might be addressed. Importantly, the suggestions summarized below do not reflect a workshop or committee consensus. They reflect individual thoughts expressed during the workshop. Several participants opined that there is no magic bullet. For example, as helpful and relevant as it may be, the traditional approach of relying on arms control is not enough, even if the BWC can evolve to overcome the challenges it faces, including more clearly accommodating the widening range of non-state bioterrorism threats. A multi-dimensional, multi-focused approach will prove more effective and timely. Elements of all measures presented during the workshop—from the BWC to the AG to all of the various informal strategic steps being taken or considered—will be critical to recognizing, anticipating, preventing, and mitigating the destructive potential associated with advancing technologies. The International Committee of the Red Cross (ICRC) refers to this approach as building a “web of prevention.” Each thread of the web may be weak on its own but together can serve the purpose. One workshop participant said that there seems to be little question that the BWC, despite the controversy surrounding a proposed verification protocol, has a definite role in preventing the assistance and propagation of bioterrorism. Perhaps most importantly, it provides a statement of universally accepted ethical norms that are considered vitally important in deterring the use of biological weapons and agents. But strengthening the BWC is only of many steps that can and should be taken. Another participant said that the United States must avoid the trap of the “silver bullet fallacy,” the notion that if a particular step does not magically solve a problem in its entirety, it ought not to be pursued. Instead, the focus should be on the broader range of smaller, feasible steps and on prioritizing these steps. An analogy was made between managing the dual-use risk of advancing technologies and fire prevention. You cannot park fire trucks outside of everyone’s house in an effort to prevent catastrophic fires. But you can take what may seem like small, mundane measures that, over the course of months and years, minimize the risk of fire and provide the means for a rapid response if fire should break out. These mundane measures include building codes, fire sprinklers, fire departments, fire insurance,

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop and the like. Together, they provide a broad-based approach to reducing the risk and consequences of fire. Likewise, a broad-based approach built on an ever-evolving set of measures, or tools, may be the best way to respond to the dual-use risks posed by the global proliferation of advancing technology. It was suggested that the response must be global and must involve international dialogue. It was argued that even if the United States chose to take unilateral action, it would not be enough to eliminate the threat posed by dual-use technology. Even with controls in place, biological materials and small equipment could be readily transported across international borders. This creates the need for very high levels of international cooperation in comparing notes, adopting measures, and meeting regularly. One of the achievements of the BWC follow-up process has been the creation of a new forum for international dialogue. But even this may not be enough, as challenges will persist well beyond 2006, when the follow-up process ends. In light of the continuing need for international dialogue beyond the formal BWC process, it was suggested that a broad-based, multi-sectoral forum be developed so that all key actors can convene and work on these issues in a cooperative way. No detailed suggestions were put forth as to how this forum would be established or what it would look like, but various groups have already planned or conceived of assemblages that could serve as models. For example, as described in Chapter 4, the European High Level Expert Group (HLEG) on “Foresighting the New Technology Wave,” as called upon by the European Commission and Member States, suggested the development of a “societal observatory.” Or, the forum could be modeled after the U.S. National Science Advisory Board for Biosecurity.36 It was pointed out that discussions need to occur at the national level as well, since all too often the multi-disciplinary nature of effective biotechnology dual-use management is underestimated at this level. The ICRC reportedly conducted a national roundtable forum in the United Kingdom on the dual-use dilemma and was told by the governing agency that this was the first time that all actors had sat around the same table to discuss their relevant and complementary roles and responsibilities. Interestingly, the United Kingdom has one of the most advanced response capabilities of any country and yet this type of discussion had not occurred before. It was suggested that the best way to address this practically infinite realm of perspectives is to seek grassroots solutions and build a strategic 36   Available at http://www.biosecurityboard.gov.