Volker Beck
Preventing Biological Proliferation: Strengthening the Biological Weapons Convention

• Risk Assessment
• Efforts to Prevent the Proliferation of Biological Weapons
• The Ad Hoc Group
• Outlook

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Volker Beck
Preventing Biological Proliferation: Strengthening the Biological Weapons Convention


A German Perspective

The development, production, storage, or any other type of possession of biological weapons is prohibited by the Biological and Toxin Weapons Convention (BTWC) of 1972. The term „biological weapon" covers agents in the form of disease-causing microorganisms and toxins as well as means of delivery for these agents. The microorganisms and toxins that can be used as warfare agents are usually not specifically developed or designed for this purpose, but selected from reservoirs occurring in nature. Most of them possess a wide area of legitimate application in the field of medical diagnostics, for the development of vaccines, for testing of newly developed antimicrobial or antiviral drugs, or as a pharmaceutical themselves. They differ from chemical agents not only by their origin and wide area of legitimate use but also by their method of production. As self-replicating organisms they do not require special-agent-designed chemical reaction lines, only multipurpose equipment, which usually does not indicate what type of agent can be produced with this equipment.

The only characteristic that can be used to assess the risk potential of a research, development, or production unit for biological agents is the safety features of a unit, which have to be observed to protect the labor force or the environment or to safeguard production against environmental impacts, according to Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP). It should be kept in mind, however, that generally the production of biological agents is possible without respecting such safety regulations. The use of genetic modification methods to increase the risk potential of biological warfare agents or to produce nonmicrobial toxins by genetically modified microorganisms basically has little influence on the laboratory and production equipment and renders no additional indicator compared to a „normal" biological facility.

Risk Assessment

The number of microorganisms and toxins that have already been weaponized or have been developed for weaponizing in the past consists of a core of about 30 different agents. However, the biotechnological development in improved production methods for viruses and developments in genetic modification have expanded the number of potential risk agents. The impossibility of real-time detection, that is, the detection of an agent the moment it is set out in the environment, the lack of potent antiviral drugs, and the impossibility of developing or using vaccines against the whole set of possible threat agents, in combination with the alarming development of far-reaching missile systems by an increasing number of states, create a higher state of concern today for biological than for chemical agents.

Efforts to Prevent the Proliferation of Biological Weapons

Export Controls

The only practical way to counter the potential misuse of biological agents for the development or production of biological weapons is the execution of export controls. These controls cover microorganisms and toxins of concern as well as key equipment necessary to handle or produce these agents. Today nearly all industrialized states and a number of

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developing countries execute such controls to prevent proliferation. However, the dilemma lies in the dual-use character of all agents and equipment concerned. Even careful case-by-case decisions for export licenses cannot exclude the possibility that export for legitimate use will be denied or that export control agencies will be misled by criminal acts. The complaints that export controls are used by the industrialized countries to cut off developing states from emerging technologies, especially in the areas of health and nutrition, are well known. The second dilemma is that export controls essentially cannot prevent the transfer of technologies to states of concern but can only delay this transfer. To the contrary, examples show that states suffering from export control regimes strengthen their efforts to gain independence from export control sooner rather than later.

Confidence Building Measures

Based on the increasing risk of biological agents and the limited value of export controls, in the middle of the 1980s the states parties to the BTWC started a discussion to improve the convention. In 1986-87 they agreed to a set of confidence building measures (CBMs) to be submitted annually to the United Nations to increase the transparency and confidence between states parties. The number of CBMs was increased once by the 1991 BTWC Review Conference. The CBM regime suffers from two flaws. First, it is politically but not legally binding. Second, the majority of the states parties to the convention did not or do not contribute to the CBMs.

Since 1987, when the first exchange of CBMs started, less than half of the more than 140 states parties to the convention have contributed to the regime. Only 11 states parties have submitted their CBMs annually to the United Nations. Roughly 15 to 20 additional states parties have contributed more or less regularly; about 30 states parties have contributed once or twice in 12 years. It is striking that some of the states parties that play a leading role in the group of the nonaligned member states (NAM) in the Ad Hoc Group in Geneva have never or only rarely submitted their CBMs.

The Ad Hoc Group

The discussion on strengthening the convention with a legally binding verification regime started at the 1991 BTWC Review Conference. At that conference it was agreed to set up a working group, the so-called VEREX Group, which collected basic ideas in 1992 and 1993 for a legally binding regime to strengthen the convention. The VEREX Group was not tasked with working on a regime but only with creating a basis for a decision on whether such a regime might be possible. However, the Group went beyond the pure collection of technically possible elements for such a regime to a discussion on whether these elements could contribute to a real verification regime or a compliance or transparency regime only. The report of the VEREX group was discussed at a Special Conference of the states parties in 1994, which mandated an Ad Hoc Group (AHG) open to all states parties to develop a protocol to the BTWC to strengthen the convention. Five years of AHG negotiations have now produced a clear picture of what a protocol could look like.

The essential elements are compliance measures, including declarations, visits, possibly as a follow-up to declarations, and investigations; scientific and technical exchange; and an organization to execute the regime.

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Common Ground

Before discussing in detail the core elements of a future protocol, it is necessary to address some principles more or less accepted by most of the states parties participating in the AHG negotiations about the underlying charter on which the protocol should be built.

First, the protocol should not amend but strengthen the convention. That means that no regulation in the protocol will replace any general rule of the convention. Even language transferred from the convention to the protocol for practical purposes may not define terms in the protocol when these definitions could possibly be back-tracked to the convention and thus change its substance. However, one partner in the AHG in Geneva still insists that the definitions of such terms should not be excluded.

Second, the convention as well as the future protocol is or will be a treaty between states to prevent the development, production, and storage of biological weapons for military use or state terrorism. For this reason the protocol addresses activities of states parties or activities under the control of states parties. The protocol does not and cannot deal with terrorist aspects of biological weapons in the hands of non-state actors. This will continue to be a case for states parties’ criminal law. The aspects of non-state bioterrorism particularly influenced the discussion in the VEREX Group and in the early stages of the AHG when the technical details of a future regime were under debate.

Third, in substantive technical and scientific parts of the future protocol, the Chemical Weapons Convention (CWC) cannot be a guideline on how to build a regime for controlling microorganisms because of their nature as self-replicating agents. Hence, it does not make sense to schedule agents according to risk assessments and to combine schedules with threshold quantities and to count quantities to be produced and transferred. However, some delegations participating in the discussions in Geneva still believe that thresholds and transfers should be a substantive part of the compliance regime. The reason for this belief is that either they want to protect their own activities, or they lack sufficient expertise to understand the difference between technologies in the chemical and biological fields and thus stick closely to the already existing CWC regime.

Fourth, it is the agreed understanding of all participants in the negotiations that the protocol should represent regulations to strengthen all provisions of the convention, including the provisions of Article III and X. However, there is no agreed understanding on how to shape regulations on transfers of materials, know-how, and technologies and on scientific and technological cooperation. This problem is related to national export control regimes. As mentioned before, some developing countries see export controls as excluding them from progress in science and technology, whereas the countries executing such regimes deem them a necessary instrument to control proliferation for illegitimate use as well as an instrument of domestic criminal law. Solving the problem of these differing opinions will be one of the most crucial parts of reaching a protocol.

Declarations

The compliance regime of the future protocol will be based on declarations of activities and facilities of greatest relevance to the convention. The protocol will not and cannot require the declaration of all activities and facilities of possible relevance to the convention. This would lead to an overburdening of the respective industries and to an information overload that could not be handled by an organization, thus leading to an ineffective regime.

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The core elements of the declarations under discussion will be built on three pillars with one single underlying concept. The concept is not to control agents but to control capabilities in the field of military biological activities, in certain areas of research and development, and in production capabilities. The last two areas include any type of civilian research and development activities like universities and industry as well as industrial production capabilities. Whereas the military pillar is split into past offensive and defensive biological activities and current biodefense activities, the civilian declarations on undertakings and facilities only cover current activities. A second difference is that civilian declarations are all related to declarable facilities that conduct research and development and production activities, whereas in the field of military activities a declaration of the whole program will be required in addition to the facility declarations.

The so-called „rolling text", which reflects the status of the negotiations and is used as the basis for further discussion, contains eight different triggers to cause declarations on programs and facilities. The first substantive discussion of all these triggers took place in the June-July 1999 session of the AHG in Geneva. The triggers cover:

• Past Offensive and/or Defensive Programs (initial declaration only);
• Current Defensive Programs;
• Vaccine Production Facilities;
• Maximum Biological Containment/BL 4 Laboratories/Facilities;
• High Biological Containment/BL 3 Laboratories/Facilities;
• Work with Listed Agents and/or Toxins;
• Other Production Facilities;
• Other Facilities.

All the triggers listed except the first require annual declarations. All triggers include a set of clauses that describe the requirements for the declaration of a facility either by distinctly enumerating activities or by distinct defining technical capabilities and activities. For a production facility, for instance, this can be the availability of fermenters above a certain size or the consumption of culture media above a certain amount per year. The trigger „Work with Listed Agents and/or Toxins" is based on a list of agents and toxins that will be annexed to the protocol and is targeted primarily to declare certain research and development activities with agents and toxins of major concern.

Not all the above-mentioned triggers are estimated to be of equal relevance, and the language of all the triggers is still in some cases far from agreed by all delegations. Disagreement so far exists between the industrialized and the developing countries on whether it is necessary to have a specific trigger on „High Containment/BL 3 Laboratories/Facilities". While the developing countries believe that such a trigger may be useful, the industrialized countries believe that the provision of information on BL 3 safety features is only of interest in combination with other declared activities and/or biotech equipment. In addition the trigger „Other Facilities" is deemed unnecessary by a number of delegations because the information requested here is already fully or partially contained in other triggers or in the questionnaire of declaration formats.

Much work has to be done to achieve consensus on the rest of the above-mentioned triggers. In the area of „Past Offensive and/or Defensive Programs" it is questionable whether the handful of states parties that once conducted offensive biological and toxic weapons (BTW) programs will be ready to accept a declaration of their past activities under a legally binding

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protocol to the same extent as they already have done under the politically binding respective CBMs. In addition, this area includes the problem of how now independent states parties to the convention on whose territories the former Soviet Union conducted parts of its offensive programs have to contribute to such a declaration. For „Current Defensive Programs" during the last 12 years only a handful of states parties contributed to the existing CBMs. From the 1998 CBM declarations it is clear that all contributing countries except for two states parties now belong to the North Atlantic Treaty Organization (NATO). About fifty percent of the declared activities concentrate on one state party, which claims special concerns in the field of bioterrorism with major national security implications. Therefore, this state party’s willingness to contribute in future to a declaration of current biodefense activities as much as in the existing CBMs seems to be decreasing. However, the other CBM-contributing states parties believe that doing less than the contents of the existing CBM on biodefense activities politically will not be sellable to their parliaments when they are going for ratification of the protocol. Finding common ground to solve this problem will not be easy.

Genetic modification is a further problem area to be discussed in the context of the triggers. Clearly the protocol has to cover any upcoming or presently developing technologies, but only to the extent that there is major relevance to the convention. For this reason a widespread technology cannot in itself stand as a single trigger. The present rolling text tries to relate genetic modification activities to work with listed agents. Given the anticipated possibility of using the institutional mechanisms of the future BTWC Organization to revise the „List of Agents and/or Toxins" according to scientific and technical developments, this subject area should be sufficiently covered.

The rolling text includes some further provisions for additional declarations or notification:

• National Legislation and Regulations;
• Transfers;
• Declarations on the Implementation of Article X of the Convention;
• Outbreaks of disease.

The transfer problem has been discussed above. Whether and how far the other declaration proposals will survive remains to be seen. The notification on outbreaks of disease is an area needing further discussion because some of the states parties are highly concerned that this measure is primarily targeted in their direction. The reason is twofold: first, because a number of the diseases under discussion are widely spread in their areas, and second, because the unusual outbreak of a disease may cause an investigation. An acceptable balance between all international institutions such as the World Health Organization or the Food and Agriculture Organization that deal with these types of diseases and the provision of information to the future BTWC Organization must be found. It should be clear that a slim and cost-effective BTWC Organization could never contain the expertise to handle all diseases of concern as professionally as the existing international institutions can do. However, this should not be used as an argument against including the unusual outbreak of a disease as a cause for an investigation.

Visits

Opinions about the appropriate follow-up measures to declarations differ very much. Delegations from the Non-Aligned Movement (NAM) Group sometimes speak of a proliferation of visit concepts in the rolling text and feel overburdened by them. Their reaction is either to accept only one type of visit, which is a voluntary visit offered by a states

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party on an invitational basis, or to move the investigation concept in the direction of the more intrusive visit concepts. This latter idea would decrease the value of the investigations, which are the only real verification element of the protocol.

The rolling text under the headline „Follow-up after Submission of Declarations" includes the following visit concepts:

• Randomly selected Visits;
• Declaration Clarification Procedures and Voluntary Visits;
• Voluntary Visits.

It must be stated that the Declaration Clarification Procedures include the element of a Clarification Visit, which is not voluntary, and that the textual approach was only done for tactical reasons to merge existing concepts as far as already possible.

At the June-July 1999 session of the AHG Germany planned to introduce an additional visit concept, the so-called Transparency Visit. The new concept tries to overcome the problem of the different visit concepts by merging acceptable elements from the existing visit concepts to create a nonintrusive, transparency increasing approach based on a model for random selection of declared facilities to be visited. The basic idea is to leave the information provided by the visited facility to the discretion of the visited state party and the facility, which can show as much transparency as deemed necessary to convince the visiting team that the activities conducted at the facility are for legitimate purposes only. The concept includes no elements of intrusiveness like sampling, accounting, and so forth, which are inspection elements that a great number of non-aligned states parties and some major biotech industry states parties do not want to accept for different reasons. One of the reasons is that by far the majority of the facilities that will have to be declared under the future protocol will be industrial ones, which may raise concerns on confidential proprietary information (CPI) protection.

The new concept was tested recently in Germany at an industrial production facility and at a military biodefense research facility. The invited test visitors from abroad conducted these two trial visits based on the German concept, which includes the use of all the trigger and declaration format concepts in the rolling text. They came to the conclusion that visits according to the new concept reach the planned aim of increasing transparency and obtaining better knowledge of the facility’s capabilities beyond what is contained in the facility declaration. These results could be achieved without compromising CPI or national security information (NSI).

The visit discussion in Geneva is so fluid that no more will be stated here than that the protocol may have a three-tier visit section as a follow-up to declarations consisting of voluntary visits, clarification procedures, including as a last resort a clarification visit, and transparency visits. The total number of all three types of visits executed over a year may, depending on the size of the future BTWC Organization, add up to approximately 100 visits.

Investigations

Investigations will be the only real verification element of the future protocol. Many of the ideas on the investigation part of the rolling text are taken from the inspection sections of the CWC. This may have some advantages as well as some disadvantages. The structure of the whole section as far as facility investigations are concerned more or less follows CWC

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procedures. However, as this is the only real inspection procedure of the BTWC protocol, this tendency shifts the whole procedural away from the more stringent challenge inspection to the less intrusive routine inspection regime regulations of the CWC. Additionally, some states parties want to allow investigations only after executing a procedure of consultation, clarification, and cooperation to solve the outstanding problem before an investigation will be launched. Others expressed concern that unusual outbreaks of disease may be reason for starting an investigation. The decision mechanisms of the Executive Council for launching an investigation - green-light procedures versus red-light procedures - still have to be discussed. Technical issues of great political relevance still have to be resolved. Examples include the rule that samples taken during an investigation can be transferred for analysis outside the territory of the investigated state party, or the maximum size of the site for field investigations, or regulations permitting moving from an already launched field investigation to a facility investigation.

Scientific and Technological Exchange for Peaceful Purposes

The subject of scientific and technological exchange for peaceful purposes is an endless circle. The problem is connected with the linkage of the requirement to increase scientific and technology exchange with the export control question by some of the states parties of the NAM Group. There is a readiness to acknowledge the need of developing countries to have access to developments in bio-sciences and technology to improve their health, hygiene, and nutritional conditions, but as long as the requirement is directly connected with the abolishment of national export controls, the space to move toward consensus seems very limited. The January 1999 idea of establishing a so-called Cooperation Committee in the future organization to solve outstanding issues of cooperation and possible transfers may provide some new momentum toward finding consensus. For the June/July 1999 session this may be the focal point for the so-called Article X/Article VII discussion.

Organization

In principle, agreement exists that the BTWC Protocol needs an organization that takes over the responsibilities of collecting the declarations, conducting visits and clarification procedures, and launching investigations. The organization is planned to be independent; however, if and what political rights the organization will receive to act independently is still under consideration, including the powers and functions of the Executive Council and the Technical Secretariat. For the composition of the Executive Council, it has to be decided if five or six regional groups will be acceptable. The question here is if there will be only one group for Asia or a split in two groups, one for East Asia and the Pacific and one for West and South Asia. Depending on which regional group states parties belong to, there are different opinions. As the number of groups will influence both the composition of the Executive Council and the split of the annual visits, this is an important problem.

Outlook

Compared with the section mentioned above, most of the other issues in the rolling text are already more or less settled, for instance the sections on

• Confidentiality provisions;
• Measures to redress a situation and to ensure compliance;
• Assistance and protection against biological weapons;
• National implementation measures;

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• Review of the Protocol; and
• the procedural sections of the protocol dealing with the status and the procedural handling of the protocol starting from signature to entry into force.

For these sections clean text is already more or less available. Therefore, all efforts to bring the negotiations for the BTWC Protocol to a successful end in the June/July and the September/October 1999 sessions have to concentrate especially on the outstanding unsolved issues in the compliance section. Only if these problems can be solved in this year will it be possible for the AHG to leave the rolling text discussion and continue its work on the basis of a chairman’s draft to start the final round for the conclusion of the protocol up to the middle of the year 2000. Before this can happen some of the opinion-maker states parties in the NAM Group have to be convinced that it is necessary to continue the negotiations with a chairman’s text. If they maintain their present position that the rolling text will be the only basis for the negotiations and that the mandate of the AHG gives a time horizon up to the next BTWC Review Conference in the year 2001 for finishing the discussions, the ambitious goal of having the protocol ready for signature before the next Review Conference will not be achieved.