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Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
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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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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?

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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);

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×
  • 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,

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

 

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.

 

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

 

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.

 

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

weapons, equipment, or means of delivery specified in Article I of this Convention.

Article IV obliges all States parties to take national measures to fully implement these obligations and responsibilities, which means that all States parties must enact national legislation containing the prohibitions of the BWC and penalties for noncompliance:

Each State Party to this Convention shall, in accordance with its constitutional practices, take any necessary measures to prohibit and prevent 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.

A question was raised about the fact that these articles and the counter-terrorist spin-offs of the follow-up process apply only to the 151 States parties to the Convention. What about the other 40 states that have not signed or joined the BWC? These 40 states are under no obligation to the BWC, are not obliged to have national laws in place regarding BWC prohibitions, and are not obliged not to assist other states or terrorist groups in acquiring the equipment, know-how, or materials to make biological weapons. This creates a major international gap in terms of preventing bioterrorists from obtaining the materials they need to construct a biological weapon or device. Moreover, although the BWC has been operational for almost 30 years, less than half of the States parties have national laws in place as required by the Convention and it is unlikely to have any influence on non-State sponsored activities.

Cooperative commitment

The difficulties that BWC states parties have experienced with regards to adopting a verification protocol and implementation norms highlight the reality that, in order to be effective, a non-proliferation regime must contain a clear cooperative commitment on the part of all those involved. Otherwise, the ensuing lack of trust makes it very difficult to meet the regime’s needs for things like data exchange; a peaceful conflict resolution mechanism; a feedback loop in order to discuss problems constructively while also allowing discussions to move forward; agreement on a sufficient level of transparency with regards to particular types of activities, such as on-site inspections; and information on capabilities and facilities. This last issue is particularly difficult for the biological regime, since the science and capabilities have already been established and it is not clear what “baseline” is.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

Several factors probably contribute to the lack of cooperative commitment to the BWC. Perhaps most importantly, partly because of the unpredictable and variable nature of the threat, there is a lack of common ground and no specific goal or weapons system. Traditionally, states voluntarily join non-proliferation regimes because it is in their best interest to cooperate, and cooperation tends to be specific, for example with regards to a specific goal or specific weapons system (i.e., one that they want to dismantle, control, or eliminate).

Voluntary commitment of states parties also reflects a shared sense of norms and standards and the willingness to create short-term sacrifices, for example by giving up some sovereignty or permitting more intrusiveness, for the sake of longer-term stability and security. As one participant noted, “It may be that, with biological weapons, countries and individuals just aren’t quite there yet.”

However, it was argued that the ultimately central role of a shared sense of norms does not mean that the BWC and biological regime cannot move forward until such norms are formally in place. After all, the international initiative to control nuclear non-proliferation occurred before shared international norms were established. In particular, the International Atomic Energy Agency (IAEA) was formed in 1957, more than a decade before the Treaty on the Non-Proliferation of Nuclear Weapons (NPT) opened for signature. Rather than because of any shared sense of what the norms should be regarding prohibiting weapons from proliferating, the IAEA was formed because of a general sense that there was a need for some sort of control. Later, the activities of IAEA were integrated with implementation of the NPT. So the IAEA created the context for the eventual establishment of a set of shared international norms.

Upholding norms

When the United States decided to withdraw from the BWC compliance and verification negotiations in 2001, there was neither enough knowledge nor broadly based political will to react strongly by either finishing the job or revising the process in a dynamic way. In September 2002, the International Committee of the Red Cross (ICRC)—seeing the implications of many recent developments in the life sciences coupled with the inability of the international community to agree on a compliance and verification protocol for the BWC—launched a very public appeal to put the dual-use dilemma and BWC issues on the political agenda. The purpose of the appeal was to raise the awareness of decision makers, and call on all actors—including industry, science, government, and the military—to recognize the risks, be aware of the existing norms, and assume their own responsibilities. Details of this public appeal are

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

included in an ICRC document entitled “Biotechnology, Weapons, and Humanity.”6

The biological prohibition regime encompasses more than law. It is also based on unspoken norms and ancient taboos stemming from the public abhorrence to poison and the deliberate spread of disease. Millennia ago, the Hindu, Greeks, Romans, and Muslim all prohibited the use of poisons, declaring their use below the dignity of any warrior. In fact, these norms are so engrained in society that one workshop participant expressed disbelief that they would ever be overwhelmed by technological advancements.

But others argue that reaffirming and upholding BWC norms will be critically important to minimizing the threats of the dual-use risk of advancing technologies, particularly since the nature of these threats changes. However, given that reaffirmation is a slow process that may not have immediate effects, it was suggested that one of the most important measure to be taken may be educational efforts to heighten awareness about the BWC and scientists’ responsibilities under the convention.

Bioregulators

Neither the BWC nor the Chemical Weapons Convention (CWC) are clear about the use of bioregulators in armed conflict. Although the BWC is very clear about not using biological agents, including bioregulators, for hostile purposes, there is some question as to exactly what a hostile purpose entails. The CWC allows bioregulators for riot control purposes but does not address their use on the battlefield. Given this vagueness and the dual-use threat posed by bioregulators, there were comments regarding the importance of clarifying these conventions.

The point was raised that many military research institutes are conducting research on bioregulators for the enhancement of soldier performance, for example by using adrenaline capsules to keep soldiers awake for several days. In fact, research on bioregulators is an accepted component of military physiological research.

Verification

The BWC has no verification protocol, an issue that has stirred up considerable controversy. There are a range of opinions about whether and how such a protocol would truly strengthen the BWC and biological

6  

International Committee of the Red Cross. Biotechnology, Weapons, and Humanity Initiative, Geneva, 2002.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

regime; and whether and how biological verification can be modeled after either nuclear or chemical verification. This section summarizes discussion on this issue.

As one participant illustrated, arms control can be viewed as a spectrum, with nuclear at one end and cyber weapons at the other. The nuclear regime is a nearly-global verification regime, carried out in large part by the International Atomic Energy Agency (IAEA) and with the Nuclear Non-Proliferation Treaty (NPT) as its pivot point. The goal of this regime is to prevent the diversion of fissile material from civilian use to weapons programs. It has enjoyed considerable success because the 1100 or so nuclear weapons facilities and installations worldwide are large and easy to find and inspect. On the other, cyber extreme, however, a comparable non-proliferation regime would be impossible since verification would require the monitoring or unannounced inspections of hundreds of millions (perhaps eventually billions) of residences and businesses.

Biological weapons (and chemical weapons) fall between these two extremes. The international verification regime for chemical weapons is more challenging than that for nuclear weapons because of the larger number of facilities and dual-use materials (there are over 5000 facilities and an entire industrial sector). Biological weapons pose an even greater challenge (although not as great as cyberweapons), since many of the relevant materials, technologies, and knowledge are far more widespread and are rapidly becoming even more so. Biological agents can be acquired from naturally occurring disease outbreaks and the course of legitimate scientific research; and producing biological agents in large quantities makes use of fermenters that are widespread in the pharmaceutical, biotechnology, and beer and wine industries.

Largely because of this challenge, the BWC lacks an inspection and monitoring regime and an agency analogous to IAEA or OPCW (the Organization for the Prohibition of Chemical Weapons; it is responsible for verification). The lack of a formal means of monitoring country compliance with BWC makes it very difficult to determine what level of defensive efforts are legitimate and which serve as camouflage for illicit weapons programs. There is concern that verification problems will become even more overwhelming in the future, as new technologies create more complicated verification needs.

It was suggested that there may be lessons to be learned from the nuclear regime, despite the very different proliferation potentials of nuclear versus biological weapons. Specifically, verification measures were integrated into the nuclear regime as a means of protection against cheating. By implementing activities ranging from data exchange to expensive, intrusive on-site inspections, verification is a way to deal with the gaps in a “worse-case-scenario” system. The rationale is that, although

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

100 percent verification may not be possible, it is possible to detect and deter cheaters as much as is necessary to avoid significant military action. During the Cold War, the United States primarily focused on its bilateral nuclear agreements and since then has focused its nuclear non-proliferation activities on keeping developing countries from developing a nuclear weapons capability. The nuclear regime has always required very detailed verifiability and accountability. The nuclear non-proliferation regime is now moving entirely away from verification and is adopting an approach that looks to how states are implementing their treaty obligations.

It was noted that one of stumbling blocks to the BWC adoption of a verification protocol appears to be that each state needs to first determine what its own standard of evidence would be and what sort of system it needs in place to collect this evidence (e.g., some states want to adopt a multilateral approach, whereas others just want a multilateral system to fill their gaps).

One workshop participant raised the possibility of a bio-safety clearing-house (either in lieu of verification or as a way to facilitate verification), whereby information is shared and stored on a voluntary basis by states parties. Some pessimism was expressed, however, with regards to whether this type of endeavor would be possible in the near future and thus whether energy should be focused toward it now.

Importantly, verification is only one of many aspects of arms control. In the nuclear regimen, it represents only about one-third of IAEA activities. Given the absolute and relative dangers of biological weapons, coupled with the fact that the same trends that alerted people in the 1990s still exist today (although the specific nature of the threats may be different), a comment was made along the lines of how difficult it is to comprehend why the nuclear and biological regime efforts have been so drastically different in terms of volume of activity. An interesting exercise for bioscientists would be to take all of the IAEA documents on nuclear safety, nuclear security, and nuclear terrorism and see to what extent those documents would be applicable to the biological arena if the word “nuclear” was deleted. In one expert’s opinion, a high proportion of those documents would be applicable, as the similarities between the two regimes in terms of soft, non-binding measures are striking.

Lessons to be Learned from the Nuclear Regime7

Many analysts are quick to look for strategic clues from the younger but more developed nuclear arms regime. With a 40 to 50 year history,

7  

Based on presentations byAmy Sands and Tibor Toth and comments by many individuals.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

beginning with the Atoms for Peace proposal in 1953, the cornerstone of the nuclear non-proliferation efforts is the Treaty on Non-Proliferation of Nuclear Weapons (NPT), which opened for signature in 1968. The UN-affiliated International Atomic Energy Agency (IAEA) was established in 1957 to reduce the risk of nuclear war and the spread of nuclear weapons to non-weapon states, as well as assisting in the use of nuclear materials for peaceful purposes. In addition to the NPT and other relevant treaties, the nuclear regime has relied on the strength of a range of other activities, including unilateral actions, supplier control, cooperative threat reduction and, most recently, the proliferation security initiative.

An important topic of workshop discussion was whether and how biological arms control can be compared to the nuclear regime and what, if any, lessons can be learned from the latter. On the one hand, some experts claim that there is a fundamental disconnect between the nuclear and biological regimes, which makes it difficult to compare them. Moreover, as the technological trajectories for nuclear and biological weapons potential diverge in the future, it will become even more difficult to compare the two. But other workshop participants argued that the parallels between the two regimes are more important than the differences and that there is a great deal to be learned from the “nuclear paradigm.”

The most important lessons to be learned from the nuclear regime may be those derived from the manner in which the regime developed through a slow, step-wise arms control process, involving various treaties and efforts. Two lessons in particular were highlighted during the workshop discussion. First, its incremental history gave rise to what has become a very flexible regime with the capacity to readily adapt to new and changing circumstances. This, despite slow improvements in the effectiveness of verification efforts (i.e., weapons inspections) and in efforts to secure universal adherence to this protocol. The same flexibility will be even more critically important for the biological prohibition regime, as the advancing technology landscape continues to change in unpredictable ways.

As a second lesson to be learned, most of the treaties and activities associated with the nuclear regime were meant to facilitate discussion in recognition of the fact that it was very difficult to otherwise constructively assemble all the relevant groups of people, including military and national security representatives. Only through such discussion could previously destabilizing, crises-driven approaches make way for peaceful, conflict-resolution approaches, while also recognizing that actions taken to reduce or eliminate threats would impact military capabilities. The early accomplishments of the BWC follow-up process seem to similarly demonstrate the value of engaging in activities that facilitate this vitally important type of discussion.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

One workshop participant pointed out that the flurry of activity in the nuclear non-proliferation regime has only been in the past five to six years, after the United States starting providing leadership and money. Given this, is U.S. leadership the missing component in the biological prohibition regime? The response was that, yes, in the wake of 2001, a new era of nuclear terrorism began, but the regime has a longer history than just these past few years. Work in the areas of nuclear safety, nuclear security, nuclear terrorism, and other areas is historically very strong, especially over the course of the last couple of decades (i.e., after the Chernobyl disaster in 1986).

Along the same lines, a question was raised about the extent to which the use of nuclear weapons on Hiroshima and Nagasaki demonstrated to the world what nuclear weapons “really mean” and catalyzed the development of a strong nuclear non-proliferation regime. Given this, again, is this what might be missing in the biological prohibition regime: an encounter with the horrific damage that a biological attack could do?

In response, it was argued that, yes, these events did play a historical role in how the scientific community thinks about the dangers of nuclear technology and why differences exist between those thoughts and perceptions of the biological dual-use threat. However, very importantly, the differences between the nuclear and biological regimes are much more complicated than by virtue of their historic past and will become increasingly complicated in the future. So the one hand, yes, perhaps these events have led to a certain expectation with regards to nuclear technology and thus a much greater level of bureaucratic involvement. On the other hand, there is really no need to demonstrate the potentially devastating consequences of biological weapons, because naturally occurring diseases clearly illustrate what could happen. Indeed, if we do not take seriously the World Health Organization’s projection that 6 million to 7 million people could potentially become victims of a flu pandemic, then we will have dozens of demonstrations of what a bioweapon could do.

The nature of biological weapons proliferation

This section summarizes discussion on how differences in the nature of nuclear versus biological threats bear on lessons to be learned from the nuclear regime. It was argued that using the term “biological arms race” connotes a meaningless analogy to the Cold War nuclear arms race, since the natures of the races are so different. Although there is legitimate concern that defensive research undertaken in one country’s program could be misperceived as offensive and could drive other nations to pursue offensive research in response, the biological arms race is not a competition between states. More accurately, it is a race against the global

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

proliferation of technology and the increasing opportunity for non-state actor access and misuse of such technology. Biological agents and technology are much less expensive and much more dispersed than nuclear weaponry and effect a much lower entry barrier.

Another way to interpret the biological arms race (to the extent that it is occurring) is as an offensive-defensive race. Again, because of the proliferative nature of biological agents and technology, the defensive challenges are great. Unlike with the nuclear regime, retaliation is not necessarily an effective defensive measure against a bioweapon attack, since a prolonged incubation time may create difficulties in tracing an attack back to its perpetrators; and non-state terrorists may not be concerned with retaliation or may not even be identifiable. The situation is further complicated by the fact that multiple offensive-defensive races are occurring. Over the last 10 years, the United States has increased defense funding more than two orders of magnitude. Other countries have similarly increased defense spending although on a lesser scale. But there’s no single, unified global mindset with respect to which agents or technologies pose the greatest risk. If one country or set of countries or set of terrorist groups is moving in one particular direction, then defensive measures and deterrent actions will be based on that regional or sub-regional mindset.

Lessons to Be Learned from the Chemical Regime8

The Chemical Weapons Convention (CWC) entered into force in April 1997.9 It is the only multilateral treaty that seeks to eliminate an entire category of weapons of mass destruction within an established time frame (by 2007, with possible extensions to 2012) and verify their destruction through inspections and monitoring by the Organization for the Prohibition of Chemical Weapons (OPCW). Although the CWC has helped reduce chemical weapons risks, CWC member states are experiencing delays in meeting CWC requirements. For example, neither Russia nor the United States is expected to have completed destruction of its stockpiles until after 2012, and less than 40 percent of member states have adopted national legislation to criminalize CWC-prohibited activities. Moreover,

8  

Based on comments by workshop participants.

9  

The treaty was the product of 23 years of negotiation and drew heavily (perhaps too much) on the IAEA experience for its routine inspection system. Its most significant advance on the nuclear inspection system was having a single verification protocol instead of the complex series of bi-lateral agreements between the inspection agency and individual governments. In this regard the CWC arrangements represents a step forward that was impossible to achieve in the period of the Cold War.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

although as of March 2004, the OPCW had conducted nearly 1600 inspections in 58 member states over the previous seven years, the organization does not have enough resources to conduct as many inspections as are needed.10

During the workshop, it was suggested that, despite apparently greater similarities between biological and chemical weapons than between the former and nuclear weapons (e.g., with respect to verification), the slower, step-wise approach to building and strengthening the nuclear regime may be the only practical option—in lieu of a “legally binding instrument” to strengthen the BWC—for managing the dual-use risk of advancing technologies.

NON-BWC TOOLS11

The lack of universality of the BWC and weak national implementation of the BWC among states parties have created “safe haven” states for terrorists. The Australia Group (AG) and the UN Security Council Resolution 1540 represent non-BWC efforts to close this “safe haven” gap. This section summarizes workshop presentations and discussions revolving around these efforts, as well as other non-BWC tools that could help inform general efforts to strengthen the biological weapons regime.

The Australia Group and Export Control12

The “Australia Group” (AG) is an informal consultative group of nations (38 countries plus the European Commission) that meet annually with the objective “to ensure, through licensing measures on the export of certain chemicals, biological agents, and dual-use chemical and biological manufacturing facilities and equipment, that exports of these items from their countries do not contribute to the spread of CBW.”13 The group formed in 1985, in response to evidence that Iraq had used chemical weapons in the Iran-Iraq war and that Iraq had obtained many of the materials for its CW program from the international chemical industry. In 1990, the AG group expanded its efforts to address the increasing spread of bioweapons materials and technology.

10  

”Delays in Implementing the Chemical Weapons Convention Raise Concerns about Proliferation,” Report to the Chairman, Committee on Armed Services, House of Representatives, http://www.gao.gov/new.items/d04361.pdf. Accessed on November 16, 2004.

11  

This section is based on the workshop presentation of Robert Mathews and comments made by individual workshop participants.

12  

Based on the presentation of Robert Mathews.

13  

Available at http://www.australiagroup.net.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

The AG’s primary activities revolve around national export licensing procedures based on the Group’s common control lists of pathogens, toxins, and equipment. All countries participating in the AG are States parties to the BWC (and CWC). The AG considers export control measures an essential means to ensure that participating countries are fully meeting their non-proliferation agreements under Article III of the BWC. The lists were first agreed upon in 1993 and have been reviewed and adjusted since then. Although the lists are not (cannot be) comprehensive, given the impossibility of controlling every pathogen, toxin, or dual-use item that can potentially be misused, a “catch-all” category is designed to serve as a safety net.

Since the early 1990s, there has been considerable debate about whether the export licensing system of the AG is a legitimate means of assisting BWC States parties in fulfilling their non-proliferation agreements (in accordance with Article III) and whether the AG system hinders free trade. However, following September 11 and the anthrax attack, a number of these previously critical countries have recognized that the AG national licensing measures are an effective means to implement non-proliferation obligations and that they do raise the barrier to biological terrorism. In fact, AG measures now serve as an international benchmark in relation to export controls, and a number of non-AG countries are adopting their own similar national licensing export systems and/or have implemented domestic monitoring procedures based on the AG dual-use lists.

A question was raised regarding whether export control, AG-implemented or otherwise, limits the capacity to rapidly response to a global infectious disease emergency. In the event of a naturally occurring emerging infectious disease outbreak, an effective response would require the rapid exchange of pathogenic strains, information, and sometimes scientists themselves. In response, it was pointed out that export controls, at least those implemented by AG states, do not ban the export of any particular materials unless there is a particular concern about possible diversion for bioweapons purposes. Listed commodities merely require an export license (because of their potential for misuse); the AG export control measures in and of themselves should not cause undue delays in terms of getting approval to export a particular strain, particularly if there is an urgent medical reason to do so.

Another question was raised about the actual extent to which export controls and other national boundary control measures are effective with respect to countering terrorism, particularly given that dual-use biological agents, knowledge, and technology are already well dispersed throughout the world. A story was told about a South African scientist who injected himself with a nonpathogenic strain of his study organism so that

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

he could “download” it and continue his vaccine research when he arrived in the United States, demonstrating the ease of circumventing the national boundary security system. In response, it was argued that export controls were not originally developed to prevent non-state terrorists from importing materials, since terrorists historically have obtained most of their materials on the domestic market. Rather, they were designed to prevent rogue states from developing weapons programs, whether nuclear, chemical, or biological.

It was then suggested that because of the limitations of export control, perhaps strengthening domestic monitoring would be a more effective counter-terrorist defense. It was also suggested that the role of a people-oriented legal framework be considered. After all, regulation is about people as much as it is about agents and materials.

UN Security Council Resolution 154014

UN Security Council Resolution 1540 (2004) represents another, more recently implemented mechanism for dealing with the same “safe haven” gaps that the AG dual-use lists are intended to close. The actual measures in place under Resolution 1540 are effectively identical to the measures to which all BWC states parties are obliged under Articles III and IV of the BWC. But unlike the BWC, Resolution 1540 applies to all UN member states, so it overcomes BWC’s problem with universality, at least with respect to counter-terrorism. All UN member states are under the same obligations as BWC states parties: all member states are obliged to have national laws in place to prohibit the proliferation of terrorism with biological materials; all member states must adopt concrete national measures to fulfill these obligations; and all member states must report to a Security Council committee. The first report was due October 2004.

Since Resolution 1540 does not provide a list of pathogens, toxins, or equipment (although it does define “related materials”), many UN member states have indicated informally that they consider the AG dual-use lists as starting points for meeting their Resolution 1540 obligations.

Environmental Treaties15

It was suggested that environmental treaties may serve as a model for managing biological dual-use threats. In particular, rather than focusing on violations and compliance and whether to sanction certain countries, environmental treaties deal with how well certain standards are being

14  

Based on the presentation of Robert Mathews.

15  

Based on workshop participant comments.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

met and whether those standards should be strengthened or enhanced. Even industry has bought into some of these treaties. For example, in order to purchase maritime insurance and conduct certain types of shipping, for example, a customer must abide by certain environmental regulations. The notion of creating incentives to do the right thing, rather than imposing sanctions for doing the wrong thing, is very different than what traditional arms control regimes have done.

South African 1993 Non-Proliferation of Weapons of Mass Destruction Act16

It was suggested that there may be lessons to be learned from South Africa’s 1993 Non-Proliferation of Weapons of Mass Destruction Act.17 The Act is successful in large part because it brings all weapons of mass destruction under one controlling regime. The Act includes a code of conduct (see below for detailed discussion on issues surrounding the need for a code of conduct for scientists). Also of note with regards to verification is how the Act provides for the protection of commercial confidentiality (so that not even the committee itself is privy to certain information that might be gleaned, for example, from an inspector); and the provision for a board of inquiry with the power to subpoena.

INFORMAL STRATEGIES18

This section summarizes workshop presentations and discussion that revolved around the many somewhat informal tools being used or considered as useful means of reconciling the dilemma posed by the bright and dark sides of the global spread of dual-use agents, information, materials, and technology. These include a code of conduct for scientists; research oversight; education and awareness-raising efforts; the unclear role of industry; and risk assessment.

Codes of Conduct19

A prominent theme of much workshop discussion was the role of the individual scientist in the misuse of biotechnology, the need to develop

16  

Based on workshop participant comments.

17  

Available at http://www.info.gov.za/gazette/acts/1993/a87-93.pdf. Accessed on October 30, 2004.

18  

This section is based on lengthy workshop discussion and the presentations of Peter Herby, Terence Taylor, Decio Ripandelli, and Abdallah Daar.

19  

Based on presentations of Peter Herby, Terence Taylor, Decio Ripandelli, and multiple workshop participant comments.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

awareness-raising strategies for scientists, and the potential role of a code of conduct for life scientists. The conduct of individual scientists is considered vitally important to successful dual-use management, as the dispersed nature of dual-use agents and materials places more responsibility on individual scientists in knowing what is happening in their sphere of influence.

However, a major challenge to developing a useful code for biological dual-use agents, knowledge, and technology is the lack of exemplary model codes. Most codes of conducts do little but gather dust.

Moreover, there are concerns that a code of conduct is useless if it cannot be implemented. It is one thing to charter a code but quite another to make it operational. This raises several questions. Who will enforce the code? What sanctions should be in place in case of non-enforcement? Can and should employment of research funding be conditional on the evidence of having followed whatever code(s) of conduct is in place? Several workshop participants agreed that, ultimately, both private and public funding organizations will play a central role in assuming ethical responsibility and monitoring research conduct. This is how most funding institutions seem to currently operate, for example with regards to the ethical use of animals.

Another potential problem is that scientists may not be willing to participate if they do not feel a sense of ownership with respect to the process. This raises the question, who would draft the code? Scientist would need to be involved, and a dialogue among scientists, bioethicists, and bureaucrats would need to be moderated and an effective means of communication developed so that scientists are involved as much as possible from the beginning.

Given the religious and cultural nature of many militant terrorist groups, an international code of conduct must reflect worldwide participation and will need to draw upon global values. If it is perceived as Western-driven, it may not be widely accepted. Indeed, this is why the working group responsible for drafting ICGEB’s code of conduct (see below) involves scientists from several different countries (the United States, Italy, Nigeria, China, and Cuba).

There are varying opinions about the extent to which a code of conduct can and should address specific needs of different fields of study and different sectors of life sciences research. Some experts suggest that any code adopted should be very specific with respect to addressing the needs of different groups of researchers. Others think that the code should be broad enough to include all fields of study and sectors of research, since the problems are the same across the board: there is a general lack of awareness regarding the law, ethic responsibilities, and how potential work could be misused by terrorists.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

A comment was made about whether it might be helpful to think of a code of conduct as an enabling platform for education and other activities. In other words, if it were considered the beginning and as something to build upon, rather than an end in and of itself, the code might stand a better chance of being implemented and proving useful. For example, although an ethics code would not prevent a determined, disgruntled scientist with malicious intent from making a bioweapon, it could create an enabling environment for voluntary reporting by people who notice unusual behavior.

Several international forums are dedicated to this debate and are making efforts to develop a biotechnological dual-use code of conduct for life scientists. For example, in 2002 the UN General Assembly and Security Council endorsed a report by the Policy Work Group on the United Nations and Terrorism recommending the establishment of codes of conduct for scientists related to weapons technologies. The 2005 BWC intersessional meeting will be dedicated partly to debating the design, promulgation, and adoption of an international code. The International Centre for Genetic Engineering and Biotechnology (ICGEB) is in the process of developing a draft code of conduct (see below), and the International Institute for Strategic Studies (IISS) has already drafted a relevant charter.

Lying mid-way between the hard norms of the BWC and the softer norms of a code of conduct, the International Committee of the Red Cross (ICRC) has been investigating the potential for a “principles of practice.” In 2002, the ICRC issued its “Public Appeal of the ICRC on Biotechnology, Weapons, and Humanity.” Directed toward all political and military authorities, scientific and medical communities, industry, and civil society, the ICRC appeal calls on all actors in the life sciences to recognize the potential risks, be aware of the existing rule and norms, and assume their responsibilities (see Box 5-2). The idea is that these principles could serve as the life sciences equivalent to the Hippocratic Oath. A comment was made that this middle ground position might address some of the challenges that a code of conduct would face but, importantly, reinforcement would still be a problem. Who would enforce these principles, and who would be responsible for taking action in the case of non-compliance?

The ICGEB draft code of conduct

In 2001, the International Centre for Genetic Engineering and Biotechnology (ICGEB; see Chapter 3 for more information on this organization) signed an agreement with the United Nations Secretariat to “cooperate in activities related to the sustainable and safe use of genetic engineering and biotechnology, as well as in the implementation of the international

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

BOX 5-2
Public Appeal (2002) of the ICRC on Biotechnology, Weapons, and Humanity

  • To all political and military authorities

  • To scientific and medical communities

  • To industry

  • To civil society

General support from States Parties to the Geneva Conventionsl 28th International Conference (2003)

In 2002, the ICRC issued its “Public Appeal of the ICRC on Biotechnology, Weapons, and Humanity.” Directed toward all political and military authorities, scientific and medical communities, industry, and civil society, the ICRC appeal calls on all actors in the life sciences to recognize the potential risks, be aware of the existing rule and norms, and assume their responsibilities.

NOTE: Adapted from Peter Herby’s PowerPoint presentation, September 21, 2004.

cooperation programmes foreseen by the convention on biological diversity and its Cartagena Protocol on Biosafety and to foster international cooperation in the exchange of information in the field of peaceful use of biotechnology, in accordance with the Biological Weapons Convention.”

Based on this agreement, in 2003, the ICGEB was called upon to “assist the UN Secretariat in fulfilling the mandate received from the Security Council to reinforce ethical norms and the creation of codes of conduct for scientists through international and national scientific societies and institutions that teach sciences or engineering skills related to weapons technologies.”

The ICGEB then received approval to establish an operational committee—composed of members of ICGEB and the National Academies of Sciences of China, Cuba, Italy, Nigeria, and the United States—to draft a code of conduct. The operational group met for the first time on May 11, 2004, in Trieste, and then again on September 27, 2004, in Rome. In April 2005, the draft code of conduct was presented to the Secretary-General of the United Nations and, in August 2005, transmitted as a working document to the BWC.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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-

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

“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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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,

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×

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.

Suggested Citation:"5 Models for Managing Change." Institute of Medicine and National Research Council. 2005. An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks: Report of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/11301.
×
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×
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