The expanding range of biowarfare threats

I agree with the other panelists that an international institution is needed to manage biorisks. The current mechanism under the Biological and Toxin Weapons Convention (BWC), which combines a work program with annual meetings of the States Parties, at expert as well as diplomatic levels, and which is supported by a small Implementation Support Unit (ISU) set up in 2007 at the U.N. Secretariat, cannot provide the necessary institutional structure to seriously address these risks at the international level.

Some in the U.S. will disagree. As Alan Pearson rightly observes, the segment of the U.S. foreign policy community that aims to prevent the use of the life sciences for hostile purposes views multilateral institutions as passé and instead sees the solution to the problem of biorisks in global networks. But such networks are temporary and aim at specific, often short-term objectives. They are useful when new issues emerge and the international community needs to react swiftly–in that context they can be effective and flexible. But they do not ensure the sustainable, long-term, and broad engagement of the international community.

The benefits of institutionalization can be seen in the efforts to improve national implementation of the BWC and the Chemical Weapons Convention (CWC). These efforts ensure the disarmament and nonproliferation objectives of both treaties and complement the requirements of Security Council Resolution 1540 to prevent proliferation of weapons of mass destruction and related materials to non-state actors.

In the case of the CWC, this has taken the form of an Action Plan of the Organization for the Prohibition of Chemical Weapons (OPCW). In the case of the BWC, national implementation is on the agenda of the intersessional process, and States Parties have reported on their status, as well as plans to enhance national implementation. The European Union, the United States, and other states have offered to help other countries develop national implementing legislation.

But there is a fundamental difference between the two processes: with the CWC, an international agency ensures consistency through common criteria and has developed the capacity to implement a sustainable assistance program to help States Parties improve their national implementation systems. The OPCW Secretariat regularly reports on the status of each State Party's national implementation. The political organs of the OPCW monitor progress and encourage states that are lagging behind to take additional action. As a consequence, assistance, both from the OPCW Secretariat and on a bilateral basis, is both sought-for and forthcoming. No comparable institutional processes exist with the BWC, and requests for assistance remain sporadic. Coordination between assistance providers is difficult, and there is little follow-up after assistance missions. The lack of institutional structure hampers efforts to improve national implementation of the BWC.

Perhaps the BWC needs a new model, as it has proved difficult to set up an international control regime based on regular declarations and inspections. It is also unrealistic to extend the scope of the routine verification system of the CWC further into the area of biotechnology, beyond the terms of the CWC's regime for other chemical production facilities. Additionally, routine verification in the field of biology would be technically difficult and ill-suited to address proliferation concerns related to non-state actors. It would require the support of bioindustries and the backing of states around the globe. I fear that there is not enough global support for a routine verification mechanism under the BWC, and that current verification concepts don't fully address the proliferation concerns emanating from advances in the life sciences.

I agree with Jonathan Tucker that the current range of international and nongovernmental initiatives will not fill the institutional deficit at the heart of the biological disarmament regime. The world needs an international agency that provides structure and institutional support for the implementation of the BWC. In my view, this agency should build on the current mandate of the ISU (which includes administrative support for BWC States Parties, universalization of the BWC, national implementation, and the implementation of confidence-building measures), and also include a mechanism to investigate allegations of breaches of the treaty. A new administration in Washington may offer an opportunity to revitalize efforts to set up such an international organization. It would be important to involve from the outset not only policy makers and security experts but also other stakeholders, including scientists and the industrial community, when defining realistic mandates and setting up effective institutional mechanisms.

Both Jonathan Tucker and Pal Aas argue that we need an international organization devoted to managing the risks associated with biotechnology. According to Tucker, the organization would act to coordinate global action to mitigate biological risks, including establishing and enforcing minimum global standards for the safe and secure handling of dangerous pathogens and the oversight of dual-use research, assisting developing countries in building capacity to implement these standards, and more generally, bolstering the norm against the hostile use of biology. According to Aas, the organization would have to work closely with other organizations, such as the World Health Organization, which have important and relevant roles to play in mitigating the risk of accidental or deliberate disease outbreaks.

These are commonsense proposals, and I hope that they will find a commonsense champion in the next U.S. administration–regardless of who wins the election this November. Unfortunately, the dominant theme today within the segment of the U.S. foreign policy community that aims to prevent the use of the life sciences for hostile purposes seems to be that multilateral institutions are passé for dealing with this problem and that what we now need are global networks. Network approaches can certainly play an important role in bringing together diverse constituencies for joint action to reduce biological risks. But how can these networks be created and maintained for the long term without active and sustained support from governments? On the other hand, institutions provide a mechanism for sustained action and support.

It's time to move beyond the either-or terms of the current debate and the failed policies of the George W. Bush administration, which prioritizes nebulous networks and coalitions of the willing while denigrating institutions and sustained multilateral efforts to address global threats and risks. Both networks and institutions have an important role to play in mitigating biological risks, and the next administration should explore how both can best be built and reinforce one another. Preventing the use of biotechnology for hostile purposes is fundamentally in the global public good, and therefore a responsibility of governments around the world.

Ralf Trapp clarified my concerns and points to the core of the problem: determining what chemicals are for law enforcement and which legal interpretations States Parties to the Chemical Weapons Convention (CWC) will accept?

Recent advances in biotechnology are outstripping legal and normative safeguards designed to protect us from the misuse of new technologies. This is why governments should introduce new international regulatory structures to ensure that terrorists and proliferators do not use the bio-sciences to acquire pathogenic materials. Most governments seem to lack the ability to address more than one risk at a time. Nuclear proliferation has for a long time held politicians' and the mainstream media's focus, but it is time to broaden that focus to include emerging bio-risks. An example of a trend that warrants attention is the mail-order "biofab" companies described by Jonathan Tucker. These labs are possible sources of new pieces of genetic information, and they are accessible to anyone.

An international control regime is the only option for covering the large area of biotechnology. Trusting such a regime might at first glance seem naive because of the difficult task of comprehensively verifying activities. But there are few alternatives other than international inspection and verification based on regular declarations. The international community needs an institutional framework to manage biorisks in broad terms, similarly to the way the Organisation for the Prohibition of Chemical Weapons controls chemical agents and non-living toxic chemicals. Therefore, I endorse Tucker's proposal for a new international body that has as its highest priority to coordinate biosecurity in broad terms. Such a body would work closely with other organizations such as the World Health Organization, which has established international standards for the safe and secure handling of pathogens.

No state or states can tackle this challenge on their own–not the European Union, the United States, or the Russian Federation. And the threat is too diverse for solutions to be carried out on an ad hoc basis. Scientists from across the globe need to be involved in the development process at an early stage and the intersessional Biological Weapons and Toxins Convention meetings are a good place to start.

On the issue of "chemicals for law-enforcement," Alan Pearson worries that declarations would not cover all incapacitating agents or that they would not even cover most of them. Clear definitions, rules, and criteria will have to be negotiated and agreed-upon. There are many issues of concern, but two are particularly important: the definition of the words "toxic chemicals" and "weaponization." In my mind, chemicals for law enforcement purposes are not weaponized according to the obligations and definitions of the CWC; these agents do, however, use a delivery or dispersion system. To me, only chemical warfare agents are weaponized. Permitted law-enforcement chemicals have to follow agreed-upon criteria. Such criteria probably will permit States Parties to use a broader range of chemical agents for law enforcement purposes than they presently do. This is why an international group should define the permitted types, numbers, and quantities, and why the stockpiles should be subject to international control.

Pal Aas queried my statement that the issue of incapacitants is not primarily about new science but about legal boundaries. Let me clarify what I meant:

Attempts to develop incapacitating agents with predictable effect and a sufficiently wide safety margin (i.e. a low incapacitating dose and a high lethal dose) are not new. What is new is that advances in the life sciences make it more likely that researchers will find new candidates for such chemical agents. This list of new candidates may include compounds that interact more selectively with specific receptor sites or those that deliver agents more selectively to their targets.

The problem posed by these possible agents is not the underlying science–any such new agent would be covered under the prohibitions of the Chemical Weapons Convention (CWC) if it were used as a chemical weapon. But can these agents be weaponized for law enforcement purposes? The answer has little to do with the chemical itself, or the science behind it. Instead, it is a matter of legal interpretation and of acceptance by the States Parties of the CWC: What does the law enforcement clause allow them to do? This question needs to be answered, even without new scientific discoveries.

This isn't to diminish the role science plays. Science is important, if only because it appears to promise the discovery of more, better candidate chemicals that could be developed into law enforcement weapons.

It's clear from this roundtable discussion that recent advances in biotechnology are outstripping the legal and normative bulwarks designed to prevent the misuse of the life sciences for hostile purposes. The challenge of managing biorisks is complicated by the fact that the relevant technologies are diffusing globally and are driven primarily by innovation in the private sector. For example, dozens of mail-order companies called "biofabs," which synthesize customized pieces of DNA for scientific and corporate clients, have emerged in locations around the world, such as China, India, Iran, Russia, and South Korea. (Examples of biofabs include Blue Heron Biotechnology in Bothel, Washington, Codon Devices in Cambridge, Massachussetts, Bioneer in Daejeon, South Korea, CinnaGen in Tehran, Evrogen in Moscow, and Tech Dragon in Hong Kong.) Yet no international regulatory structures are in place to ensure that proliferators and terrorists do not use these firms to acquire pathogenic genes and lethal viruses.

One problem is that governments lack the political will to address the risks associated with emerging biotechnologies in a concerted manner. Not only has renewed concern over nuclear weapons proliferation overshadowed biological and chemical threats in the eyes of policy makers, but they also tend to believe that the dual-use challenges posed by biotechnology fall into the "too-hard" category.

At the international level, the lack of an institutional framework has hampered efforts to manage biorisks. Ever since the collapse in 2001 of negotiations to develop an inspection protocol for the Biological and Toxin Weapons Convention (BWC), which would have established a new international organization to oversee the treaty's implementation, efforts to prevent the misuse of biotechnology for weapons purposes have proceeded on an ad hoc basis. BWC member states have agreed to gather each year until the next review conference in 2011 to discuss various topics related to the treaty, but these meetings are confined to exchanges of information, with no decision-making. Moreover, in contrast to the International Atomic Energy Agency in Vienna and the Organization for the Prohibition of Chemical Weapons (OPCW) in The Hague, no international organization has the mandate to bolster the norm against the hostile uses of biology, establish and enforce minimum global standards for the safe and secure handling of dangerous pathogens and the oversight of dual-use research, and assist developing countries to build capacity in these areas.

Seeking to fill this institutional deficit, a number of international bodies have launched initiatives in the biosecurity field, including the World Health Organization, the Organization for Economic Cooperation and Development, and the International Criminal Police Organization (Interpol), as well as nongovernmental organizations such as the International Committee of the Red Cross and the Verification Research, Training and Information Centre. These efforts, while individually useful, remain scattered and poorly coordinated.

Another proposed approach to remedy the deficits in the biological disarmament regime is to draw on the verification mechanisms of the Chemical Weapons Convention (CWC) where they overlap with the BWC, namely with respect to non-living toxic chemicals produced by living organisms (toxins and bioregulators). Yet little progress has been made on this track. Although the OPCW has a Scientific Advisory Board that monitors scientific and technological developments with implications for the CWC, the board lacks credibility and political weight, and none of its recommendations has been approved by member states. Moreover, the Second Review Conference of the CWC this past April was characterized by disruptive North-South tensions that blocked consensus on major steps to adapt the CWC verification regime to the changing nature of the global chemical industry and the growing convergence of chemistry and biology, as Ralf Trapp noted earlier. The international community appears deadlocked about how to manage the dual-use risks associated with the galloping advances in biological science and technology.

One new initiative offers a possible way forward. In November 2006, shortly before completing his second term, U.N. Secretary-General Kofi Annan gave a speech at the University of St. Gallen in Switzerland in which he warned that as advanced biotechnologies become increasingly available, their safety and security risks will increase exponentially. "When used negligently, or misused deliberately, biotechnology could inflict the most profound human suffering–ranging from the accidental release of disease agents into the environment to intentional disease outbreaks caused by state or non-state actors," he said. To address this danger, Annan proposed that the United Nations coordinate a global forum to discuss how to make the benefits of biotechnology available to all, while managing and mitigating its potentially catastrophic risks. The forum would not be a new U.N. organization but rather a series of high-level meetings involving world leaders from government, industry, science, public health, and law enforcement.

Annan's successor Ban Ki-Moon did not assign a high priority to the St. Gallen initiative, which has since received little public mention. Nevertheless, a small group of champions has met quietly during the past 18 months to flesh out the proposal, which is likely to be unveiled in the fall. The U.N. global forum on biotechnology should play a valuable role by helping to educate government policy makers and the general public. Even so, it will not fill the institutional deficit at the heart of the biological disarmament regime. Managing the dual-use risks associated with biotechnology requires coordinated global action that only an international organization can muster. There is simply no way that the United States can tackle this thorny problem on its own.

My concern with Jonathan Tucker's proposal to establish a new subcategory for declaring "other chemical production facilities" that manufacture peptides is not that it would not cover all incapacitating agents; it is that it would not even cover most. This would make it an easy target for those who oppose efforts to address the incapacitants issue, and those with vested interests in the broader issue of inspections of "other chemical production facilities." Given the challenges surrounding both of these issues, Tucker's proposal strikes me as not the best path forward at this time.

As Ralf Trapp so clearly explains, the crux of the problem is how one draws the line between toxic chemicals that can be weaponized for law enforcement purpose and toxic chemicals that are weaponized for use as chemical weapons. Trapp is concerned that my proposal for States Parties to pursue agreed criteria, standards, and methods to determine whether a toxic chemical or delivery system is consistent with law enforcement purposes would result in an open-ended approach where compliance would depend on how individual states interpret and apply the criteria. I'm not sure how this differs from the present situation, except insofar as it may provide some agreed-upon rules. Yes, some states might see such rules as permission to engage in activities that today are viewed as legally ambiguous–and in this case Trapp's concerns are justified. I'm not sure I see another way forward, however, but would be interested in hearing other ideas for moving us beyond the current stalemate.

Tucker raises two new and interesting points. Regarding the possibility that genetically engineered microbes could be used as delivery vehicles for incapacitants, I agree with Trapp that this belongs in the realm of the Biological and Toxin Weapons Convention (BWC). However, the CWC will remain the central forum for resolving the debate on incapacitants, because, unlike the CWC, the BWC does not provide an explicit exception for law enforcement purposes, and thus states are unlikely to pursue biological incapacitants as long as the issue of chemical incapacitants remains unresolved. If states do end up deeming chemical incapacitants as acceptable under the CWC, then pressure may well arise to allow for biological incapacitants under the BWC. (It also may not, as infectious agents would have longer onset times and be even less predictable than chemical agents in terms of their effect, making them less useful for the types of applications that have been discussed for incapacitants.)

With regard to truth serums, I agree with both Aas and Trapp that this issue goes beyond the CWC to include ethical issues. In fact, the use of a chemical agent for purposes of interrogation probably would not fall under the remit of the CWC. But more than just ethical issues are involved. The use of chemical agents for interrogation would also clearly bring international human rights law into play.

Finally, Aas makes the point that the failure of the CWC's Second Review Conference to set up a mechanism to further address the incapacitants issue means that more scientists, nongovernmental institutions, and others should increase their engagement in the years before the next Review Conference. But engagement requires financial support. Unfortunately, as those of us involved in both biological and chemical weapons nonproliferation efforts know only too well, such financial support is rapidly drying up. If Aas is correct, and I believe that he is, then the future does not look promising. More than the relatively narrow issue of incapacitants is at stake.