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Experts tackle some of the toughest topics of the day and unpack their arguments in this three-round format. Each author writes one essay per round.

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Development and Disarmament Roundtable

The expanding range of biowarfare threats

Scientists are developing new substances at the cross section of biology and chemistry--such as peptide bioregulators--that could be used to incapacitate and kill. These substances defy the typical biochemical threat spectrum that includes microbial pathogens such as the anthrax bacterium and toxins such as botulinum.

Round 1

03/06/2008 - 07:00

What's the difference between prohibited and permitted chemical agents?

Ralf Trapp
03/12/2008 - 07:00

Producing new bioweapons isn't easy

Pal Aas
03/18/2008 - 07:00

Could incapacitating weapons become "everyday" weapons?

Alan Pearson
03/26/2008 - 07:00

The bioweapons threat is broader and closer than commonly thought

Jonathan B. Tucker

Round 2

04/14/2008 - 22:00

We may not have the right tools to control the emerging threat

Ralf Trapp
04/16/2008 - 11:19

The need to quickly define law-enforcement agents

Pal Aas
04/28/2008 - 09:56

The core issues underlying the threat of incapacitants

Alan Pearson
04/30/2008 - 13:20

Doing what is possible to limit incapacitants, what about truth serums?

Jonathan B. Tucker

Round 3

05/09/2008 - 13:42

When states fail to address incapacitants

Ralf Trapp
05/16/2008 - 15:27

Priorities for improving the chemical weapons treaty

Pal Aas
05/23/2008 - 09:04

Broader issues than incapacitants are at stake

Alan Pearson
05/28/2008 - 22:23

Managing biorisks: The need for international solutions

Jonathan B. Tucker
06/03/2008 - 11:31

Defining legal boundaries for incapacitating weapons

Ralf Trapp
06/17/2008 - 09:53

A new international biorisks organization is needed to ensure security

Pal Aas
06/24/2008 - 09:58

Biosecurity networks are lacking compared to multilateral institutions

Alan Pearson
07/02/2008 - 10:42

Biosecurity solutions beyond the BWC

Ralf Trapp

Round 1

03/06/2008 - 07:00

What's the difference between prohibited and permitted chemical agents?

The title of Jonathan Tucker's article could easily have been "the body's own chemical weapons." I'm making this point to highlight the convergence between biology and chemistry--a development whose implications for arms control needs further study. The emergence of new chemicals that interfere with brain functions or other regulatory processes in humans (such as bioregulators and neuroactive peptides) is a key feature of this crossover.

Military interest in this type of toxic chemicals is not new; what is new is the scientific potential opened up by the biological revolution, combined with advances in engineering and information technology. Scientists' expanding understanding of biological systems combines with advances in particle engineering and the promises of nanotechnology for the development of "smart" delivery systems to carry biologically active chemicals to specific target organs or receptors. The synthesis of complex molecules of biological origin including peptides has also become much easier than in the past.

At the same time, the demand side is evolving, with military requirements adapting to the changing nature of warfare. So-called nonlethal weapons are drawing attention, and scientists are assessing incapacitating chemicals that interfere with human body functions and should have pharmacological safety margins sufficient to avoid killing the target population. To be clear, scientists debate whether it is possible to develop chemical or biological agents that can satisfy the requirement of "non-lethality." (See this recent British Medical Association report). But this discussion misses an important point: The mere fact that there may be an agent that may satisfy the requirements to an extent that may be judged acceptable could suffice to stimulate research and development of new incapacitating agents.

The implications for the Biological and Toxin Weapons Convention (BWC) and the Chemical Weapons Convention (CWC) could be serious. Both treaties approach the weapons they ban in a comprehensive manner, defining the purpose (intent) of using an agent for weapons purposes as the criterion for deciding whether a chemical or biological material is a prohibited weapon or a legitimate material. That consideration also applies to incapacitants. Contrary to Tucker's argument, the status of incapacitants under the CWC is far from ambiguous; or rather, if their status was ambiguous, the status of any toxic chemical, whether lethal or incapacitating, would be, too.

The CWC has some contradictions, though. It allows toxic chemicals to be used for law enforcement purposes, including domestic riot control. Yet, it unequivocally bans the development, acquisition, stockpiling, and use of chemical weapons. Is it possible to distinguish whether a toxic chemical or a delivery system are intended solely for law enforcement purposes and not as a new chemical weapon? What features, characteristics, and parameters would be consistent with law enforcement, and which stipulate chemical weapons? Neither question has a simple answer. Restrictive interpretations of the convention limit the law-enforcement clause to a state's rights to use certain toxic chemicals for domestic riot control; liberal interpretations accept a range of possible uses of any toxic chemical under a state's jurisdiction but call for voluntary declarations to enhance transparency.

Tucker suggests that States Parties should limit the types and quantities of toxic chemicals that they stockpile for law enforcement purposes. He also proposes ways to modify the CWC's verification system to take account of the risks associated with bioregulators. In my view, before one can address the second proposal, there needs to be a common answer to the first one. CWC States Parties have so far failed to discuss the use of incapacitants for law enforcement purposes--this question was in the "too-difficult" category. Expecting the upcoming CWC Review Conference to resolve this issue would be setting it up for failure.

Scientists and policy makers have publicly debated many of the issues related to the use of incapacitants for law enforcement purposes, and States Parties should initiate a thorough discussion of the matter at the state level. This discussion should aim to clarify the demarcations between legitimate developments and prohibited activities. Such a discussion would also help to understand possible verification requirements for the crossover between chemistry and biology. In Julian Perry Robinson's words, the creeping legitimization of incapacitants would lead to a new generation of psychochemical weapons. If ignored, this issue could weaken the fabric of the CWC and open the door for a resurgence of chemical warfare of a new kind.

03/12/2008 - 07:00

Producing new bioweapons isn't easy

"The Body's Own Bioweapons" is an informative and well-balanced presentation of the possible threats posed by mid-spectrum agents, such as bioactive molecules derived from the human body.

Security experts and members of the arms control community identify bioterrorism and the production of bioweapons on a small and large scale as one of the most challenging threats to national and international security. There are reasons to argue against such statements.

First of all, the development and production of bioweapons is a difficult and sophisticated task. It is not an exercise in which individual terrorists will engage but is more likely the terrain of states or industries with a high-level of scientific and technological knowledge. The steps--production, dissemination, aerosolization, spray-drying, microencapsulation, etc.--necessary to weaponize large volumes of materials are complex. If terrorist organizations developed these capabilities it would be a serious challenge.

In particular, the development of lethal agents or agents that impair brain function, emotion, or cognition constitutes a serious threat to individuals. However, Tucker hits on an important point when referencing examples of what Soviet scientists achieved on this front during the Cold War. They were all frightening examples of possible threats from large state bioweapons programs. Thus, the international community should be making more efforts to force signatory states and nonsignatory states to ratify the Chemical Weapons Convention (CWC) and the Biological and Toxin Weapons Convention (BWC). In addition, states should negotiate a verification protocol for the BWC. Increased commercial interest in bioregulators and the rapid development of production technologies have additional implications for these treaties.

In addition, the various interpretations of the term "law-enforcement" in the CWC are problematic. If states accept a broad interpretation of the law-enforcement exemption in the CWC, they should specify and limit the types and production-volumes of agents. Furthermore, necessary verification measures should be introduced that cover the "law enforcement" use of "bio-chemicals." These points should be addressed at the upcoming CWC review conference.

It will be difficult to change the CWC or amend its lists of chemicals, so other options must be considered. I agree with Jonathan Tucker’s idea of modifying the provisions in the CWC Verification Annex that cover "other chemical production facilities." This approach would increase the international control of the production of such possible threat agents.

More generally, the next biothreat could be chemicals derived from the human body, but this would take time. In the wide spectrum of biochemical agents available as terrorist weapons, other agents are probably of greater interest today and during the next decade. In my opinion, conventional explosives will continue to be the primary weapon for most terrorist groups. The next option will probably be classical chemical warfare and/or biological warfare agents and radiological agents. Toxic industrial chemicals are another possible and realistic alternative, as these chemicals are easily available.

03/18/2008 - 07:00

Could incapacitating weapons become "everyday" weapons?

All of the participants in this roundtable have identified states and their interest in incapacitating chemical weapons as the primary cause of concern regarding bioregulators and their chemical analogs. This may seem strange to readers in the United States where discussions of biological and chemical weapons overwhelmingly focus on terrorism. But my colleagues are right. Not only are states expressing interest in the developments Jonathan Tucker describes, which they believe will provide the basis for "usable" (i.e. useful and politically acceptable) chemical weapons, but only states have the capabilities needed to see the development of such weapons through from agent discovery to weapons deployment.

As Ralf Trapp points out, interest in incapacitating chemical weapons is not new. In fact, for nearly 60 years, advocates for such weapons have been able to convince funders that, because of advances in science and technology, "usable" incapacitating weapons are just around the corner. Yet somehow the promised incapacitants never seem to arrive. That today's scientific advances are enabling new ways of manipulating human physiology and brain function does not necessarily mean that new chemical incapacitants are any more likely to be "successful" than the old.

That said, Trapp's point that the mere possibility of "success" could suffice to stimulate research and development of new incapacitating chemical weapons has repeatedly been proven. Even more, the belief that researchers have developed an "acceptable" weapon could lead its use, as occurred in Moscow in 2002. For now, I am more concerned about these beliefs than I am about the possibility that a truly nonlethal incapacitating chemical weapon could be developed. The reason lies in the malleability of the concept of acceptability, which varies according to time, place, and context. I'm concerned that increased interest in incapacitants will generate pressures that lead to the use and proliferation of weapons that are deemed "good enough." In other words, if and when "success" comes, it may be due more to a redefinition of acceptability than to advances in science and technology. Then, the institutionalization, conventionalization, and marketization of the new chemical weapons (whereby they become more like small arms sold in the global market than like strategic weapons held by a restricted number of states) may well lead to an ever-expanding definition of acceptability, ever-broader range of uses, and a more powerful array of new and improved agents. (As a corollary, scientific debates about the likelihood that researchers can develop truly nonlethal chemical weapons will play a larger role in determining whether incapacitating weapons are developed and, especially, used than Trapp may grant.)

My colleagues also appear to agree that the States Parties to the Chemical Weapons Convention (CWC) must somehow set limits on the types and quantities of toxic chemicals that can be used for law enforcement, and ultimately must establish measures for monitoring and verifying compliance with these limits. But what limits, and how to set them?

Tucker proposes a "modest" first step--that States Parties declare their stocks of law enforcement chemicals and delivery systems. This could be useful if the declaration mechanism includes a specific definition of "law enforcement chemicals." Without a specific definition, States Parties could use the declaration mechanism to try to legitimize a wide and potentially open-ended range of chemicals for law enforcement purposes. An agreement to develop such a mechanism would provide a focal point for efforts to develop criteria, standards, and methods for determining whether a toxic chemical or delivery system is consistent with law enforcement purposes.

States Parties would have to address the central question raised by Trapp--what is the difference between prohibited and permitted chemicals? This question is really two questions: What actions qualify as law enforcement purposes under the CWC, and what characteristics of toxic chemicals are and are not consistent with such purposes? The first question relates to the hotly contested boundary between law enforcement and armed conflict, an issue that extends beyond the CWC. In the context of the CWC, the term clearly means more than domestic riot control. I believe that it means less than counterinsurgency operations, and that it excludes mixed combatant/noncombatant situations.

While complete resolution of this question within the CWC seems unlikely, even partial agreement would inform discussions of the second question, which falls squarely within the CWC. Nothing in the convention prevents States Parties from setting whatever criteria they collectively agree on, except that chemicals listed in Schedule 1 of the Verification Annex (like mustard and nerve gases) are definitely prohibited for law enforcement purposes. Some observers suggest that law enforcement chemicals be limited to those which meet the definition of riot control agents ("any chemical not listed in a Schedule, which can produce rapidly in humans sensory irritation or disabling physical effects which disappear within a short time following termination of exposure"). However, powerful States Parties, including the United States and Russia, are not inclined to agree.

Perhaps there is another approach. Law Professor David Fidler argues that, based on international human rights law, the more toxic a chemical is and the more difficult it is to control the effects of its use (i.e. to control the individual dosage received and/or the exposure conditions), the less likely that the chemical is of a type consistent with a legitimate law enforcement purpose. Might it be useful to incorporate the concept of controllability into the definition of law enforcement chemicals? For example, could they be defined as chemicals that produce "reliably controllable and temporary incapacitation which disappears within a short time following termination of exposure?"

Tucker proposes that the States Parties establish an advisory panel to explore the full range of relevant issues and provide a menu of policy options for regulating incapacitants. Such a panel could be the focal point for discussions leading to a declaration mechanism. Julian Robinson has suggested establishing an open-ended working group [PDF] with a mandate to develop guidelines for interpreting the law enforcement exemption, but not pursuing a declaration mechanism at this time. Whatever States Parties decide, they should begin a joint process of thoroughly examining Trapp's question. And whatever the outcome of this process, it should result in criteria, standards, and methods for determining whether a toxic chemical or delivery system is consistent with law enforcement purposes.

03/26/2008 - 07:00

The bioweapons threat is broader and closer than commonly thought

I don't disagree with most of my colleagues' points, particularly with respect to the debate over the use of incapacitating chemicals for law enforcement purposes. I differ slightly, however, with Pal Aas's contention that any bioterrorist threat associated with the misuse of bioregulators lies in the distant future.

For the near term, it's clear that the primary risk lies with states seeking novel incapacitating agents for counterterrorism operations. Looking ahead 10 or 20 years, however, one cannot be confident that terrorists will stick to guns, explosives, and "classical" agents such as Sarin or anthrax. Given the global diffusion of biotechnology, it seems likely that these capabilities will trickle down to extremist groups and brilliant but sociopathic loners such as the Unabomber. Indeed, the current preoccupation with "dual-use research of concern" in the life sciences is based on the belief that terrorists will eventually exploit cutting-edge advances for hostile purposes.

Take the case of synthetic genomics. Within the past decade, the advent of automated, high-throughput DNA synthesizers has made it possible to synthesize genes and even entire genomes from scratch. Since 2002, molecular biologists have assembled the genomes of three functional viruses in the laboratory--poliovirus, the phiX174 bacteriophage (a virus that is parasitic on bacteria), and the 1918 pandemic strain of the influenza virus. In January 2008, researchers at the J. Craig Venter Institute in Rockville, Maryland, announced that they had synthesized a simplified version of the genome of the bacterium Mycoplasma genitalium containing all of the genes needed to sustain independent life. This "minimal genome," made up of 582,970 DNA base pairs, is 10 times larger than any piece of DNA previously synthesized.

These remarkable achievements have resulted in a shift from materials-based risks to knowledge-based risks. High-throughput synthesizers can rapidly convert a DNA sequence stored in computer memory into the physical reality of a pathogenic gene or an infectious virus. Moreover, companies that synthesize custom pieces of DNA to order for corporate or scientific clients are springing up around the world, even in cities such as Beijing, Mumbai, and Tehran. Some of these firms, called "gene foundries," are capable of making gene-length DNA strands that can be ordered over the Internet. Access to this capability could eventually enable technically skilled individuals to construct deadly viruses such as Ebola in the laboratory, circumventing governmental controls on "select agents" of bioterrorism concern.

Given the existence today of thousands of "black-hatted" software hackers who create and disseminate destructive computer viruses for their own personal gratification, it does not seem far-fetched to worry about the possible emergence of a new generation of hobbyists or "biohackers" who exploit biotechnology for malicious purposes. The pool of individuals with relevant technical know-how is expanding rapidly as the field of synthetic biology attracts established researchers, graduate students, and even undergraduates. For example, MIT sponsors an annual International Genetically Engineered Machines competition in which student teams manipulate advanced genetic components and technologies. This event has grown from five teams in 2004 to 54 teams (750 students) from 19 countries in 2007.

Although scientists and engineers tend to be skeptics who are not usually attracted to religious cults or extremist groups, there are exceptions to this rule. During the 1990s, for example, the Japanese doomsday cult Aum Shinrikyo successfully recruited university-trained chemists and biologists, suggesting that smart but alienated people suffering from a spiritual vacuum in their lives may be susceptible to a charismatic leader who provides a sense of meaning and belonging. Motivations for a scientist to develop an advanced bioweapon could be religious, ideological, or strictly personal, such as a bitter grudge against a former employer or an ex-lover.

An unknown variable is the skill set needed to carry out a high-end bioterrorist attack. Kathleen Vogel of Cornell University has argued that in addition to "explicit knowledge," such as recipes for producing and formulating pathogens or toxins, a bioterrorist would have to acquire two types of "tacit knowledge" that cannot be reduced to writing. Personal tacit knowledge refers to hands-on laboratory skills developed by working with biological agents and specialized equipment, while communal tacit knowledge derives from close working relationships with specialists from various disciplines. According to Vogel, such knowledge can be acquired through person-to-person transfer ("learning by example") and trial-and-error problem-solving ("learning by doing").

The need for tacit as well as explicit knowledge to weaponize and deliver biowarfare agents may limit the ability of ordinary scientists to exploit advanced biotechnology for hostile ends, reducing the risk of high-end bioterrorism. Given current technological trends, however, it would be unwise to rule it out entirely.

Round 2

04/14/2008 - 22:00

We may not have the right tools to control the emerging threat

The potential misuse of advances in the life sciences by terrorists cannot be ignored--there is evidence both of intent and rudimentary capability. But I agree with Pal Aas that these threats can be exaggerated. Even if terrorists could manage aspects of the development, testing, and production of a novel agent, weaponization remains a challenge. Therefore, opportunistic approaches, such as the diversion of toxic or infectious materials from available sources, are far more likely.

I agree with Jonathan Tucker that we need to worry about scientists being recruited by terrorist organizations, as well as "biohackers." I also agree that they would need both explicit and tacit knowledge to transform a candidate novel agent into an effective weapon. I nevertheless feel that the threat is limited and the potential impact more local than it is sometimes portrayed. Tucker's point that the current preoccupation with "dual-use research of concern" in the life sciences is based on the belief that terrorists will eventually exploit cutting-edge advances for hostile purposes, however, is too narrow a view--what about the potential "siphoning-off" of new discoveries by states, inadvertent discoveries, or lab accidents. Plus, it does not take new life science research for terrorists to acquire a chemical or biological weapons capability--just think of the animal diseases, plant diseases, and materials and wastes that are all around us.

Additionally, neither the Biological and Toxin Weapons Convention (BWC) nor the Chemical Weapons Convention (CWC) is truly universal, and some states outside these treaties have the scientific capacity to pursue chemical or biological weapons and perceive their security to be threatened enough that they could be tempted to do so. The historical record, furthermore, shows that some States Parties to these treaties might try to exploit grey areas in the margins of their legal undertakings. This is why we need to resolve the incapacitants issue.

In regard to incapacitants, I agree with Pearson that the problem is more one of a redefinition of acceptability than of advances in science and technology. Thus, CWC States Parties may need to discuss ways to rework declarations and perhaps verification protocols. But first they need to agree where to draw a line between chemical weapons, and chemicals and delivery systems acceptable for law enforcement use. Tucker's proposal for an advisory panel on this matter is therefore important. It could draw on the recent academic debate, but it must also commit States Parties to resolve the issue in full appreciation of the long-term impact of their decision on the CWC. Pearson suggests that this process should result in criteria, standards, and methods for determining whether a toxic chemical or delivery system is consistent with law enforcement purposes. This seems to presuppose that states have discarded the "narrow" interpretation of the law enforcement clause that only riot control agents are allowed, and I am not sure that this is indeed so.

On the broader question of what to do about the growing cross-over between chemistry and biology, the "other chemical production facilities" regime would likely be involved, as both Tucker and Aas point out. This regime is the only tool in the CWC that could meet demands for transparency and control in this evolving field of science and technology.

I'm concerned, however, that the CWC was never designed to deal with the types of facilities and activities that would need to be covered. Tucker acknowledges this when he proposes a new subcategory for peptides with a declaration subthreshold high enough to exclude university and research facilities but low enough to capture commercial peptide production plants that could support a state-level biochemical weapons program. Even with a high threshold, however, it may not be easy to marshal the necessary political support from States Parties and acceptance from industry. States Parties, relevant companies, and industry associations need to explore more thoroughly what can, and what cannot, be done. The persistent lack of agreement on a verification scheme under the BWC demonstrates that there are limits to the acceptability of international verification at advanced biotech facilities. At the same time, the progress in national BWC implementation (including a closer association of security and safety issues) and the work toward codes of conduct and other self-regulatory measures in industry, research, and academia point to avenues that should be further explored by the Second CWC Review Conference.

04/16/2008 - 11:19

The need to quickly define law-enforcement agents

I wonder why my colleagues in the United States seem to focus on the threat of terrorism when discussions of bioweapons surface? I suggest that we turn our attention to states with advanced industrial capabilities--the greatest concern when discussing the possible production, proliferation, and use of novel agents such as "the body's own bioweapons." Terrorists will likely continue to make use of more readily available options: explosives, toxic industrial chemicals, or classical chemical warfare agents.

This does not imply that scientists should neglect research on future bio-threat agents or on their countermeasures. This research is essential for obvious reasons. The broad group of potential bioweapons presented by Jonathan Tucker consists of many possible new agents, including bioregulators, psychoactive agents, and substances that can affect the human immune, cardiovascular, or gastrointestinal system. These agents fall into several categories of chemicals, and scientists will need to develop countermeasures to such agents, to decrease human vulnerability and increase survivability.

According to Alan Pearson, increased interest in incapacitants will generate pressures that lead to the use and proliferation of weapons deemed good enough; a redefinition of acceptability will follow. I agree, and for this reason such developments should be addressed within the Chemical Weapons Convention (CWC). The further this discussion is delayed, the more complicated and difficult it will become. But is it possible to distinguish between chemicals and delivery systems for use in law enforcement and those that are to be used as chemical weapons? Before we enter into a discussion on verification measures, and limits in general, States Parties need to define law enforcement substances. Otherwise they could seek to legitimize the use of a wide range of substances or, as Ralf Trapp suggests, try to exploit gray areas in the margins of their legal undertakings. Tucker's proposal to establish an advisory panel to decide what chemicals and equipment is acceptable for use in law enforcement is a reasonable suggestion. It is also time to ask if law enforcement substances--a broad term--should be treated differently than riot control agents.

Once these questions have been resolved, then we can consider developing a verification system that accounts for the risks of bioweapons such as bioregulators. This will be challenging since some States Parties as well as advanced biotech companies oppose a comprehensive verification scheme. The objective would be to establish limits on the types and quantities of toxic chemicals, such as law enforcement agents, and internationally acceptable measures for monitoring and verifying these limits. The rapid development of new technologies should enhance the focus on solving these important matters, because it will take time to introduce control measures. If we ignore the potential of incapacitants as described by Tucker, then we will weaken the fabric of the CWC and possibly open the door for a resurgence of chemical weapons.

04/28/2008 - 09:56

The core issues underlying the threat of incapacitants

On the issue of incapacitants, my colleagues and I are pretty much in agreement--States Parties to the Chemical Weapons Convention (CWC) should establish clear boundaries between prohibited chemical weapons and toxic chemicals and delivery systems that are permitted for law enforcement purposes. Then they should develop mechanisms to ensure that states abide by their agreements.

Ralf Trapp is concerned that my proposal--that States Parties pursue agreed criteria, standards, and methods to determine whether a toxic chemical or delivery system is consistent with law enforcement purposes--appears to presuppose that states have agreed to discard the "narrow" interpretation of the CWC's law enforcement clause that only riot control agents are allowed. I disagree. Fifteen years of experience has shown that framing the discussion in terms of whether or not law enforcement agents include more than riot control agents has been unproductive. It has enmeshed debates about what agents might be permitted for law enforcement purposes with debates about whether riot control agents are toxic chemicals. These two issues are related, but it would be more productive to put aside the second issue for now in order to focus on the first.

This framing also fails to recognize how advances in science and technology increase the potential for states to seek opportunities within the CWC's definition of a riot control agent. For example, the powerful anesthetic remifentanil, related to the agent used to resolve the Moscow theatre hostage crisis, might well qualify as a riot control agent if one narrowly interprets the CWC. Yet common sense tells us that such an agent would be qualitatively different from the tear gasses and pepper spray that comprise present stockpiles of riot control agents.

For these reasons, it's time to move away from the question of whether law enforcement agents are limited to riot control agents and toward addressing the core principles underlying the CWC. The end result can't be predicted, but such an exercise could find that only agents that are more or less like today's riot control agents meet the agreed criteria and standards. Other outcomes are also possible. But at least the findings would be built on the foundations of the CWC, and all states would be better positioned to control the resulting situation than if they continue to avoid discussion and let developments happen state-by-state.

Tucker suggests that to address incapacitants, States Parties should create a new subcategory for declaring "other chemical production facilities" that manufacture peptides in quantities exceeding a certain threshold. This proposal is intriguing but inadequate, because most of the incapacitating agents of concern are unlikely to be peptides. For example, most of the more than two dozen potential incapacitating agents identified in the Applied Research Laboratory report Tucker initially refers to are non-peptide chemicals.

Both Aas and Trapp point out that developing a verification system for addressing the convergence of chemistry and biology will be extremely challenging. Indeed, the convergence is rendering the chemical weapons problem increasingly like the biological weapons problem, with the number of potential threat agents expanding to the point that traditional means of agent-specific control are becoming inadequate. States need to develop mechanisms to verify compliance with basic CWC prohibitions rather than simply verifying that adherents don't possess a specified list of chemicals. This is a more difficult task, and I agree with Trapp that the CWC was not designed to deal with this situation. Thus states will need to explore other avenues for verification. The central goal must be to find ways of increasing transparency and reporting about chemical activities and holdings, both to other states parties and to the public. The greater the transparency, the more likely non-transparent states will stand out.

A final thought: Even though the Biological and Toxin Weapons Convention does not directly involve incapacitants, biology and biologists certainly will be involved in their development. Researching new incapacitating chemical weapons will require using the latest in biological knowledge and technologies. Life scientists have generally been able to avoid the arms control implications of their fields because the biological weapons problem has largely been perceived as far removed from their work. If states opt to develop incapacitants, scientists will no longer be able to avoid the issue. Then, life scientists individually and as a community will either allow themselves to become enamored with visions of "humane" chemical weapons, as scientists have in the past, or will have to resolutely resist their development.

04/30/2008 - 13:20

Doing what is possible to limit incapacitants, what about truth serums?

Alan Pearson's latest comment criticizes my proposal to establish a new subcategory in the Chemical Weapons Convention (CWC) for declaring "other chemical production facilities" that manufacture peptides in quantities above a specified threshold because this approach would not cover all incapacitating agents, many of which are not peptides.

In response, I would argue that my proposal, while not a panacea, is still worth doing. Several bioactive peptides have been identified that act on neural circuits in the brain to induce confusion or placidity, making them (or their analogues) of considerable interest as incapacitants or calmatives. Thus, while a technical amendment to the CWC verification annex requiring the declaration and inspection of facilities that manufacture peptides in significant quantities would not capture all incapacitating agents, it would be fairly easy to do and would address an important part of the problem. I agree with Pearson that additional transparency measures, such as the voluntary submission by member states of more detailed information on "other chemical production facilities," would help to build confidence in compliance with the General Purpose Criterion.

On another matter, Seth Carus at the National Defense University has called to my attention the fact that bioregulators need not be delivered in chemical form. According to the memoirs of former Soviet bioweaponeer Ken Alibek, the Soviet Union developed genetically engineered bacteria containing inserted genes coding for bioactive peptides, which would be expressed only after the bacteria infected a human host. This delivery method offers operational advantages over the dispersal of bioregulators as pure chemicals. Because the genetically engineered bacteria would replicate in the infected individuals, the quantity of agent that would have to be disseminated to cause incapacitating or lethal effects over a large area would be significantly less than if pure bioregulators were used.

Employing genetically engineered bacteria as a delivery vehicle for bioregulators also has implications for arms control. A bioactive peptide (either purified from a natural source or synthesized chemically) that is acquired or used for hostile purposes clearly meets the treaty definition of a "toxin" or "toxic chemical" and hence would be banned under both the Biological and Toxin Weapons Convention (BWC) and the CWC. In contrast, a genetically engineered bacterium containing a bioregulator gene that is expressed only after infection would escape the control mechanisms of the CWC. To give an analogy, the CWC's General Purpose Criterion bans the development, production, stockpiling, or use of botulinum toxin as a weapon. Yet the prohibitions of the CWC do not apply to Clostridium botulinum, the bacterium that produces and releases botulinum toxin only after infecting a host. For this reason, bacteria containing bioregulator genes would be covered by the BWC but not by the CWC, and hence could not be subject to enhanced verification measures under the latter treaty.

Another issue that has yet to be addressed in this roundtable is the potential use of drugs based on bioactive peptides to enhance the interrogation of alleged criminals or terrorists. For decades, a holy grail of the U.S. intelligence and law-enforcement communities has been the development of a "truth serum" that causes a suspect to divulge information against his will. Drugs that have been used in the past for this purpose include sodium pentothal, sodium amytal, and scopolamine, none of which are considered 100 percent effective at obtaining truthful information. During the Cold War, the U.S. military and the CIA also experimented with hallucinogenic drugs as interrogation aids. For example, the CIA's Project MK-ULTRA, which began in 1953, involved the administration of LSD to unwitting subjects.

The ethical abuses of Project MK-ULTRA led the U.S. government to end its search for a truth serum in the late 1960s, at least officially. Since 9/11, however, some observers have advocated for the renewed use of such drugs. In April 2002, for example, former CIA and FBI director William Webster said that the United States should consider administering "truth drugs" to uncooperative suspects held at Guantánamo Bay and elsewhere to obtain details about terrorist operations. Webster asserted that the use of a short-acting drug would not constitute physical abuse.

Although existing truth serums are all flawed, ongoing academic and pharmaceutical research on bioactive peptides that regulate neural circuits in the brain involved in emotion and cognition may eventually produce new drugs that could enhance interrogation in a reliable and predictable manner. Oxytocin, for example, has been found to promote trust in situations characterized by risk and uncertainty. I would be interested in the views of my colleagues with respect to the feasibility of developing a bioregulator-based truth serum, and whether the use of such a drug for interrogation purposes would be permitted under the law-enforcement exemption of the CWC.

Round 3

05/09/2008 - 13:42

When states fail to address incapacitants

Discussions of security risks will eventually have to take account of the readiness of governments to address them and agree on practical solutions. The Second Review Conference of the Chemical Weapons Convention (CWC), which included representatives from 114 national governments, has just completed its work--how did it deal with the issues identified in this roundtable?

Several countries raised the possible implications of using incapacitants for law enforcement purposes, but the conference took no action. And it did not set up a mechanism, such as the advisory panel suggested by Jonathan Tucker, to further evaluate the matter. This inaction does not preclude future discussions within the Organisation for the Prohibition of Chemical Weapons (OPCW), which is responsible for implementing the convention, but it may make those discussions more difficult. I would be skeptical about pursuing the debate further through the OPCW's Scientific Advisory Board. Some representatives at the recent review conference attempted to create a "filter" between the advisory board and the OPCW's political organs. In the end, it requested the OPCW's director-general to provide advice on how governmental experts can be involved in the interaction between the advisory board and the policy making organs of the OPCW. In any event, the issue of incapacitants is not primarily about new science, which is the domain of the advisory board, but about legal boundaries.

I agree with Alan Pearson that any further debate needs to start by evaluating the core principles underlying the CWC. The question is whether states can agree on criteria to determine when types and quantities of toxic chemicals are no longer consistent with law enforcement. I doubt whether debating the toxicity of chemicals in itself is of much use as Fidler seems to suggest (see Pearson's first posting in this roundtable). The other idea suggested, namely that one can control the effects of agents (and use controllability to establish which agents are legitimate) is at odds with the complexity and diversity of human beings and the unpredictability of operational conditions under which such weapons would be used. States may need to address other factors such as dissemination methods, delivery systems, tactics, and how to ensure transparency in activities that may well be perceived by others as the beginning of an offensive chemical program.

In general, the delineation of legitimate uses would have to be set in the context of the broader undertaking not to develop, produce, stockpile, or use chemical weapons. This is the crux of the problem. If one accepts that toxic chemicals can be weaponized for law enforcement purposes, how does one draw that line?

I cannot predict the outcome of this larger discussion, but the solution needs to be practical, scientifically sound, and consistent with the core principles of the CWC. I am skeptical about that solution taking the form of agreed criteria, standards, and methods to determine whether a toxic chemical or delivery system is consistent with law enforcement purposes. That would suggest an essentially open-ended approach where compliance would rest on how individual states interpret and apply these criteria.

On the related question of how the industry verification regime of the CWC should evolve further, the Review Conference gave some general guidance but failed to conceal significant disagreements between States Parties about which types of activities and facilities pose a risk to the CWC. New initiatives, along the lines suggested by Tucker, were given little room for discussion.

One piece of good news did come from the conference. In the context of reviewing the verification of "other chemical production facilities," the conference noted "the desirability of directing inspections towards facilities of greater relevance to the object and purpose of the Convention and of removing irrelevant facilities from the declarations and inspections," and asked the OPCW's director-general to explore options on the issue. This process could create an opportunity to further the discussion of risks associated with bioregulators and peptides. But I'm not overly optimistic, as proposals must be consistent with the present set of provisions for other chemical production facilities, meaning there will be no new declaration requirements or verification provisions.

In his latest comment, Tucker raised the issue of genetically engineered bacteria as a delivery vehicle for bioregulators. I agree that this belongs in the realm of the Biological and Toxin Weapons Convention. I would argue that the common understandings developed by its States Parties over the years ensure that such bioengineered delivery systems are covered under its prohibitions, but of course there is no international routine system to verify treaty compliance.

Finally, Tucker raised the potential use of bioactive peptides in interrogations of alleged criminals or terrorists and asked whether ongoing academic and pharmaceutical research on bioactive peptides that regulate neural circuits in the brain may produce new drugs that could enhance interrogation in a reliable and predictable manner. I don't want to speculate how likely that is from a scientific point of view, but whether the use of such compounds would be legitimate under the CWC is only half the question. Even if it was considered lawful within the CWC framework, legitimacy should involve a broader examination of medical risks as well as ethical questions related to interfering with the personality and cognition of individuals for law enforcement purposes.

05/16/2008 - 15:27

Priorities for improving the chemical weapons treaty

Some States Parties to the Chemical Weapons Convention (CWC) are concerned about limiting the development and possible use of incapacitants for law enforcement. This was clear during the negotiations of the CWC. Other countries would like to have the right to produce any chemical, drug, or other agent for law enforcement purposes. Such agents could have several effects on humans, including altering brain function. Discussions between these groups about whether riot control agents are the only law enforcement agent allowed under the CWC have not resulted in further agreement. But it is time to close this potential loophole. It was disappointing that the CWC's Second Review Conference failed to address this issue, but this failure should result in the involvement of more scientists, nongovernmental institutions, and others, and increase their engagement in the years before the next review conference in 2013. It is not too late--a more effective strategy must, however, be developed.

It is essential to take account of the potential effects on humans of existing and new agents as described by Jonathan Tucker. Scientists have identified several bioactive peptides, proteins, and other synthetic and naturally occurring chemicals that affect the human nervous system and cause a wide range of symptoms. If, to guard against the illicit production of these agents, states institute a verification annex that requires declarations and inspections of facilities producing and using significant quantities of these agents, then all such production facilities should be included and not just the few that produce limited types of agents. Rapid developments in the life sciences will result in new means of incapacitation, and most of the incapacitating agents are unlikely to be peptides, as Alan Pearson argues.

Tucker raises another important issue: new and potentially harmful delivery methods that weren't even considered possible while the CWC was being negotiated, such as using bacteria or other living cells to deliver agents. Toxins and agents developed under the cover of "law enforcement" can be delivered in bacteria and are not subject to enhanced verification measures under the CWC. This is an excellent example of the type of new developments that should be monitored by scientific advisory boards.

Tucker also addresses the issue of truth serums. Eventually such serums will be developed and be available for interrogations. But are they a violation of the CWC? Their use would probably be legitimate under the CWC framework, but only as a domestic law enforcement agent. Interfering with the personality and behavior of humans will raise ethical issues, however, and such agents could be prohibited as a result. The use of toxic chemicals as law enforcement agents, as raised by Ralf Trapp, is out of the question but serves to emphasize the necessity of addressing and clarifying the law enforcement issue.

Ralf, can you clarify what you mean when you say, "The issue of incapacitants is not primarily about new science . . . but about legal boundaries." From what I have read during the past few months and years, the development of incapacitants is closely linked to scientific developments. Regardless, I agree with Tucker that the implications of using incapacitants for law enforcement purposes needs to be addressed, sooner rather than later. The Organisation for the Prohibition of Chemical Weapons's Scientific Advisory Board could help advance this debate.

On the issue of verifying "other chemical production facilities," I agree with the Second Review Conference's support for "directing inspections towards facilities of greater relevance to the object and purpose of the Convention." I share Trapp's concerns, however, that this position limits new declaration requirements or verification provisions.

05/23/2008 - 09:04

Broader issues than incapacitants are at stake

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.

05/28/2008 - 22:23

Managing biorisks: The need for international solutions

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.

06/03/2008 - 11:31

Defining legal boundaries for incapacitating weapons

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.

06/17/2008 - 09:53

A new international biorisks organization is needed to ensure security

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.

06/24/2008 - 09:58

Biosecurity networks are lacking compared to multilateral institutions

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.

07/02/2008 - 10:42

Biosecurity solutions beyond the BWC

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.