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"No one can solve this problem alone, but together we can change things for the better." 

– Setsuko Thurlow
Hiroshima Survivor
June 6, 2016
The Protocol to the Biological Weapons Convention Is Within Reach
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June 2000

By Graham S. Pearson

The Biological Weapons Convention (BWC) prohibits all use of disease as a weapon of war to attack humans, animals, or plants.The convention, which opened for signature in 1972 and entered into forcein March 1975, currently has 143 states-parties and 18 signatories. However, it lacks any provisions for monitoring compliance, and concern about biological weapons has increased since it entered into force.

Fears about biological weapons programs in so-called rogue states were magnified when the United Nations Special Commission on Iraq (UNSCOM) gradually uncovered significant elements of the Iraqi biologicalweapons program, which had succeeded in filling missile warheads and aircraftbombs with biological agents. These weapons were deployed during the Persian Gulf War with predelegated authority for use had allied coalition forces attacked Iraq with nuclear weapons. Putting global biological weapons development in perspective, John Holum, then director of the U.S. Arms Control and Disarmament Agency, noted in a statement to the 1996 fourth BWC review conference that twice as many states had or were seeking biological weapons as in 1975.

At the second BWC review conference in 1986, states-parties took the first steps to strengthen the BWC by agreeing on politically binding confidence-building measures, which were then extended and enhanced in 1991. These measures require states-parties to annually declare their maximum containment facilities, biodefense programs, past offensive and defensive programs, human vaccine facilities, information related to the outbreakof disease, and information on national legislation and regulations implementingthe BWC. However, only about one-half of all states-parties have made a single declaration and only 11 have made annual declarations. Moreover, the information provided in these declarations has been patchy and has not contributed to building confidence in compliance.

At the third BWC review conference in 1991, the BWC states-parties,"determined to strengthen the effectiveness and improve the implementation of the Convention and recognising that effective verification could reinforce the Convention," decided to establish an Ad Hoc Group of Governmental Experts (known as VEREX) to identify and examine potential verification measuresfrom a scientific and technical standpoint. Under the leadership of Ambassador Tibor Tóth of Hungary, VEREX met twice in 1992 and twice in 1993 and produced a final report evaluating 21 off-site and on-site verification measures. A special conference in September 1994 considered this final report and established another Ad Hoc Group to negotiate a legally binding protocol "to strengthen the effectiveness and improve the implementation of the Convention." This Ad Hoc Group, also chaired by Tóth, firstmet in January 1995. Now, over five years later, it has held 19 sessions and has met for about 50 weeks.

In July 1997, the Ad Hoc Group successfully transitioned to negotiation of a rolling text of the draft protocol, the 12th version of which was issued in April 2000. This text contains a preamble and 23 articles, together with annexes and appendices. Although the draft protocol is approaching its final form and many of its key provisions are agreed upon, some important outstanding issues remain. It is possible, however, to reach compromise on these issues while accounting for different states-parties'concerns and still meeting the group's mandate to strengthen the BWC.2What remains is the need for a display of political will, which appears to be present, as evidenced by recent statements from a wide range of countries.

 

The Protocol Regime

To ensure compliance with the BWC, the draft protocolrelies on a three-pillar architecture, consisting of mandatory declarations,declaration follow-up procedures, and investigations of non-complianceconcerns. In addition, the protocol contains measures to promote scientificand technological exchange and international collaboration.

The first pillar requires states-parties to submit declarationson activities or facilities of relevance to the BWC. These declarationsare built largely upon the same requirements that were agreed to in earlierconfidence-building measures, although much effort has been put into makingthe requirements unambiguous and into determining which items the declarationsshould include.

The BWC protocol's declaration follow-up procedures arebased on a package of measures that include infrequent randomly selected/transparencyvisits to declared facilities, declaration clarification procedures, andvoluntary assistance visits. Randomly selected/transparency visits willbe infrequent and are intended to ensure that declarations are consistentwith requirements. The protocol also enables these visits to provide adviceand technical assistance to states-parties, furnishing a useful bonus.The second set of measures, procedures to clear up "ambiguities, uncertainties,anomalies or omissions" in declarations, can range from written correspondencethrough a consultative meeting to, if necessary, a clarification visit.Finally, voluntary assistance visits will help requesting states implementthe protocol or participate in technical cooperation for peaceful purposes.

Both the randomly selected/transparency visits and theclarification visits have evolved from the experience gained in implementingthe Chemical Weapons Convention (CWC), in which routine inspections aremade to declared facilities engaged in producing chemicals identified in"schedules." These visits should ensure that the protocol regime is morereliable. The facilities declared under the protocol will only be thoseof the greatest relevance to the BWC. And unlike routine CWC inspections,which are limited to the production plant declared within the facility,the protocol does not limit visits to specific elements of declared facilities.

The investigation of non-compliance concerns is dividedinto two categories: field investigations and facility investigations. The former measure covers instances in which exposure of humans, animals,or plants to biological agents has given rise to concern about possiblenon-compliance or alleged use of biological weapons—in other words, whenthere has been an unusual outbreak of disease that appears not to have been caused naturally. This measure would investigate cases such as the1979 anthrax outbreak at Sverdlovsk in the Soviet Union. Facility investigations can be conducted if a state-party has a non-compliance concern about aparticular facility. These measures, which are confrontational and comparableto challenge inspections under the CWC, are highly political in natureand will be extremely rare events. They are, however, vital elements ofthe overall regime.

If, after an investigation, the Executive Council of theprotocol's implementing organization judges that a state-party is non-compliant,it may then recommend that the protocol organization's Conference of theStates Parties take appropriate measures, such as suspending the state-party'srights and privileges under the protocol or bringing the issue to the attention of the United Nations General Assembly or Security Council. It may also recommend other measures that are in accordance with international law and designed to fulfill the convention's object and purpose.

Other elements in the protocol include significant provisionsin Article VII for measures promoting international scientific and technicalcooperation for peaceful purposes, such as monitoring and controlling infectious disease and improving biosafety. Developing countries have long been pressuring developed countries to elaborate such specific measures in order to improve the implementation of BWC Article X, which obliges states-parties to cooperate on peaceful activities. Article VII has grown significantly during the negotiations to its current length of 13 pages, which can be compared tothe one-page article on cooperation in the CWC. There is a general appreciation that the measures under Article VII will bring benefits, particularly tot he developing countries. Over time, such measures will promote the protocol's universality and help build much-needed infrastructure within these states.They will also increase transparency and build confidence in compliance with the convention.

 

The Devil Lies in the Details

While the Ad Hoc Group has successfully elaborated the protocol's main provisions, negotiators have yet to agree upon some key details. This point was addressed during the last Ad Hoc Group session, held March 13 to 31, by a number of states-parties, who stressed that the group must now focus its attention on resolving these issues in order to conclude the negotiations.

Transfer/Export Control Regimes

The principal transfer issue now is what export controlregime should be established under the protocol and how it would regulate transfers between protocol states-parties and transfers from protocol states-parties to protocol non-states-parties (both those that belong to the BWC and thosethat do not). Developed countries are concerned that such a regime might require them to lower their export control that they may have to lower their standards to a point that interfereswith their obligations under the Australia Group—an informal multilateral export control body that harmonizes its member-states' export controls. However, developing countries want to ensure that the regime will not establish such a stringent transfer control regime that it precludes their access to biotechnology.

Declaration Triggers

The delegations broadly agree that states-parties should declare facilities and activities that are most relevant to the convention. However, negotiation continues as to precisely what criteria would trigger a declaration. That is, what conditions would require a state-party to declare a certain facility or activity? These requirements must be unambiguous so that all states declare comparable facilities and activities. Negotiators generally agree on the need to declare past offensive and defensive biologicalwarfare programs, current biological defense programs, maximum containmentfacilities, vaccine production facilities, and facilities working withlisted agents. However, other triggers such as high containment facilities,"other production facilities," and outbreaks of disease are still being debated.

The tension in this aspect of the negotiations is again between the developed and developing countries. The developed countries are aiming for the triggers to strike the right balance so that the most relevant facilities are declared in all countries without placing a disproportionate burden on themselves. For example, if the triggers were to include high-containment facilities, a very large number of facilities would need to be declared. However, the vast majority of these facilities would be solely in developed countries and would include facilities that present little risk to theconvention. The developing countries, however, want to see the burden placed primarily on the developed countries, who have the most facilities of concernto the BWC, and therefore advocate triggers that would accomplish such a result.

Studies by a number of states-parties have shown that under the protocol's current provisions, a developed European country would have to declare only tens of facilities, significantly fewer than the number declared under the CWC. The CWC requires facilities to submit declarations if they deal with any significant quantity of scheduled chemicals or produce discrete organic chemicals. However, the BWC protocol declaration net is structured differently, designed to focus on the most relevant facilities.Under the protocol, not all facilities dealing with agents listed in the protocol have to submit declarations. Only those dealing with listed agents under certain conditions must provide declarations. Furthermore, the negotiators have been careful to make sure that facilities will not have to declareany commercial proprietary information or national security information. Such a design should be welcomed, as pharmaceutical trade associations have been very concerned about the protection of commercial proprietary information because of the industry's major investments in research and development.

Declaration Follow-Up Procedures

The negotiators generally agree that the protocol should include a package of declaration follow-up procedures, including infrequent randomly selected/transparency visits to declared facilities, declaration clarification procedures, and voluntary assistance visits. However, they disagree on some of these arrangements' details. Some non-aligned states suggest that only biodefense and maximum containment facilities should receive randomly selected/transparency visits—effectively ensuring thatonly facilities in developed countries would be subject to these visits. However, the Western Group—comprised of the European states, Argentina, Australia, Canada, Japan, New Zealand, South Korea, and the United States—argues that all declared facilities should be subject to these infrequent visits, which would not number more than two or four a year per country.

The Ad Hoc Group is also divided over whether clarification visits should be voluntary or mandatory and whether they should apply to facilities that appear to meet the declaration requirements but have not been declared. The conflict is once again between some of the non-aligned states and the Western Group. The non-aligned states argue that clarification visits should be voluntary and should not apply to undeclared facilities. This strategy seeks to limit the number of facilities that this type ofvisit could cover. However, the Western Group, seeking an effective declaration regime with consistent requirements for all states-parties, favors mandatory clarification visits and application of clarification procedures to facilities that should have been declared but were not.

Investigations

The process for initiating investigations is another key issue that is not yet resolved. European states and most others in the Western Group, though not the United States, favor a strong regimein which a requested investigation would take place unless a majority of the Executive Council votes to stop it (the so-called red-light procedure). This procedure is similar to the way challenge inspections are initiated under the CWC. However, some of the non-aligned countries and the UnitedStates argue for a much weaker regime in which a requested investigation would not take place unless a majority of the Executive Council votes fori to take place (the so-called green-light procedure). These states fear that misuse of the red-light system by other states-parties might force them to receive frivolous or abusive inspections.

The United States' reluctance to support a strong regimeis surprising and worrying, as in the past it has generally been a leaderin developing strong regimes to counter the proliferation of weapons ofmass destruction. This reluctance appears to parallel the U.S. positionon the CWC. As a consequence of conditions in the Senate's advice and consent to ratification, the United States issued CWC implementing legislationi n 1998 that refused to allow samples obtained during a challenge inspection to leave the United States and granted the president the right to veto a challenge inspection on national security grounds. These positions are totally at variance with presidential statements calling for strong measures to counter weapons of mass destruction in general and the use of disease as a weapon of war in particular.

Prohibitions, Definitions, and Thresholds

During the negotiations, most states have argued that when defining terms in the protocol care must be taken not to amend the scope of the convention—a task for which the Ad Hoc Group has no mandate. However, this has not prevented some states, notably Russia and Ukraine, from proposing definitions that would effectively modify basic prohibitions laid out in Article I of the convention—terms such as "biological weapons," "biological agents," and "hostile purposes." These states contend that including these definitions in the protocol would not aim to revise theBWC's scope, but would enhance the accuracy of what the protocol should verify.

The role of thresholds for agents listed in the protocol has also been debated throughout the negotiations. Some delegations have sought to establish quantitative thresholds below which listed agents are permitted in certain quantities. They argue this would permit the retention of agents for peaceful purposes and establish universal guidelines for what is a permissible amount of agent. However, most delegations have argued against establishing any thresholds below which retention of an agent is automatically accepted. They argue that the nature of biological agents would allow a state to retain a quantity below the threshold limit but to rapidly grow the agent to levels above the threshold. They further contend that a particular quantity of agent may be entirely justified for peaceful purposes in one state but not in another.

The Way Forward

It is important to recognize that in negotiating the protocol BWC states-parties have had different aims and aspirations regarding the details of what should be incorporated into the protocol. However, during the Ad Hoc Group's sessions, the states-parties have gained an understanding of these different aims and aspirations and have identified compromise measures and language in many areas that a great majority, if not all,of the states-parties find acceptable. While some observers are pessimistic about the early conclusion of the protocol, it is worth recalling the Brazilian statement in March: "Pessimism is often expressed under the noble disguise of realism. But pessimism, however intelligent and reasonable it might sometimes sound, is always a self-fulfilling prophecy."

It is far better to focus on the widely shared appreciationamong the delegations that they should complete the protocol now. During the group's last session, India asserted, "The shared objective of concludinga viable protocol of universal acceptability can be achieved before the next review conference in 2001." The three codepositaries stated, "Successful achievement of an effective protocol within the agreed time frame must be the objective of all states-parties," while the United States added that it considered the group's work "to be of the utmost importance." Along these lines, Hungary said, "There is a need to act upon the 1996 consensus expectation, which mandates you to conclude the negotiations at any time before the 2001 review conference." In addition, Australia contended, "We have reached the stage where there is not much more to do, except turn our minds to resolving the fundamental differences which stand between us and a completed protocol."

The Ad Hoc Group will meet again for four weeks in July and has made provisions for further two-week sessions later in the year. All that remains is to reach final consensus on certain substantive issues.How then can the outstanding key issues be resolved? It has to be recognized that in the endgame of the negotiations the remaining issues are all interlinked and the scope for individual resolution is limited. It is therefore necessary to consider the outstanding issues in the round. The two most contentious issues relate to transfer/export controls and the initiation of investigations under the protocol.

Transfer/Export Controls

When deciding whether to permit a transfer to another state-party to the protocol, many states have indicated that, in accordance with their obligations under BWC Article III on transfers, they would need confidence that the transfer would only be used for permitted purposes. Furthermore, they would want assurance that the receiving state-party would not retransfer the export internally or externally without approval. The three requirements are thus that there should be transparency regarding the end-use of transferred materials and equipment, national controls onfacilities handling particular agents and transfers between such facilities, and national controls on transfers between states-parties.

To realize these requirements, the protocol regime should establish minimum standards for transfers. It will then be a matter for individual states to decide whether they need to adopt and implement more stringent regulations, thereby meeting developed countries' concerns about maintaining export control standards. The protocol should also contain provisions to increase exporting state-parties' understanding of and confidence in importing states-parties' activities. Such measures should increase confidence that the importer has appropriate internal and interstate controls. Over time, this heightened understanding between states-parties should increase the likelihood that states-parties will approve transfers to eachother. Thus, increased transparency and confidence should lower barriers to trade and placate developing states-parties' concerns on trade barriers while developed countries' export control standards are still met.

As with the CWC, it is possible that the protocol mayalso include requirements for the states-parties to review whether to tightenrestrictions on or prohibit exports to non-states-parties. It is evidentfrom the CWC's implementation that when transfers to non-states-partiesbecome increasingly controlled and prohibited, the safety and securityof states-parties is enhanced and non-states-parties are given a strongincentive to join the regime.

Therefore, negotiators need to develop provisions in the draft protocol requiring states-parties to introduce transparent nationaland interstate controls on transfers. Provisions already in Article VIIof the protocol for scientific and technological exchange and international cooperation will enable assistance to states-parties to establish the necessary national infrastructure and capabilities.

Investigations

Investigations are the ultimate compliance measure in the protocol. As discussed, some states, because of concerns about abuse, are wary of a robust regime that would allow investigations to go forth without an Executive Council vote. However, provisions to protect against abuse already in the text, which are at least as strong as those in theCWC, will suffice—measures such as the Executive Council voting to stop an investigation or deciding on redress should it conclude that there has been abuse. Furthermore, experience with the CWC shows that frivolous and abusive requests for challenge inspections are not being made and are unlikelyt o be made.

It is not correct, as argued by some states, that a simple green-light procedure is equivalent to a simple red-light procedure. The basic presumption under a green- light procedure is that an investigation will not take place unless a majority of states explicitly vote in favor. This results in a much weaker regime than one in which states-parties are confident that protocol provisions and organization procedures can handle serious requests for investigation while filtering out frivolous or abusive requests.

The political resolution of this issue requires recognition of the importance of a strong regime ensuring that the Biological WeaponsConvention is effectively strengthened and implemented. Failure to do so runs the risk that enforcement of the protocol could be subjected to unrelated political conflicts, which would rapidly undermine the regime.

Other Issues

The other outstanding issues—prohibitions, definitions,and thresholds; declaration triggers; and declaration follow-up procedures—areless contentious. While the Ad Hoc Group remains divided on these matters,their resolution is also achievable.

Insofar as definitions are concerned, most negotiators agree on the need to define terms only when necessary to avoid ambiguity—termslike "facility." However, some states want to define terms that would result in the expansion the BWC's scope. The solution is to limit definitions to only those necessary for an unambiguous and effective protocol while noting the existing provision for states-parties to broaden the scope ofthe convention at BWC review conferences.

Regarding thresholds, because of the nature of microorganisms and the relative ease with which they can be grown, there is less technical justification for thresholds in the BWC protocol than in the Chemical Weapons Convention. Including thresholds that allow biological agent in any particular quantity runs the risk that a state-party can possess a quantity below the threshold on the day of a visit or investigation, but grow this agent into a quantity greatly in excess of the threshold within days. Using thresholds to establish guidelines for the amount of agent permitted for peaceful purposes, as suggested by some states, is therefore inappropriate.

Rather than having guidelines for what is permitted, states-parties should provide quantitative information about the production capacities of their facilities and about the quantities of agent they produce. Any judgment as to whether retaining a quantity of agent is justified under the convention would depend on the purpose and would be made at another time, such as during an investigation.

For declaration triggers and declaration follow-up procedures, the outstanding differences relate to which facilities states-parties should declare. The debate focuses on high-containment facilities, "other production facilities," and precisely which facilities working on listed agents shouldbe declared. In each of these categories, the problem is how to avoid requiring declarations for less relevant facilities. Requiring the declaration ofsuch facilities would result in an increase in the declaration burden with relatively little real gain in transparency and confidence.

The solution is to use combination triggers. For example,a combination trigger would not require a declaration from a high-containment facility per se but would require a declaration if that facility were working on a listed agent and had a certain production-scale capability.

With respect to visits, the sensitivity in the negotiations relates to the frequency with which declared facilities would be visited and what the visits would do. Since the Conference of the States Parties will directly control the frequency of visits through its annual scrutiny and approval of the protocol organization's program and budget, it is unnecessary in the protocol, as in the CWC, to specify an overall limit on the number of visits, of whatever type. Indeed, specification of such a limit in theprotocol's articles would be unwise as it would reduce flexibility and efficiency by removing any incentive for the future organization to optimize its operations.

The director-general could provide additional assurance to states-parties regarding planned visits by notifying the Executive Council every three months of the overall plans for visits for the forth comingthree months. However, the plan should not include sufficient detail to enable states-parties to identify which states-parties would receive a visit in the next quarter.

It is evident from the Chemical Weapons Convention's implementation that there are numerous occasions on which clarification is needed on information provided in states-parties' declarations. Correspondence or consultation with the state-party concerned will resolve the vast majority of these instances. However, visits to facilities or activities of concern may well be the most efficient and effective way of resolving the problems. The contention within the negotiations is whether clarification visits should only be made at the invitation of the state-party concerned or whether the protocol should require such visits. The solution would be to enable a state-party to refuse the proposed clarification visit if it considers that it has taken all reasonable steps to clarify the issue. Such a refusal should then be reported to the Executive Council, which could then factor in the refusal if deciding whether to approve a request by another state-partyfor an investigation.

Another point of contention is whether declaration clarificationprocedures should apply both to declared facilities and to facilities thatthe protocol organization or states-parties believe should have been declared.A solution would be to permit declaration clarification procedures to addressboth declared facilities and those that the organization or other states-partiesbelieve should have been declared. The protocol should also make provisionfor the state-party concerned to refuse clarification procedures with such refusals being reported to the Executive Council. Overall, these measureswould significantly increase confidence that the declaration requirementsare being consistently applied to all states-parties and thus enhance confidence in compliance with the protocol.

 

The Importance of the Protocol

Taken as a whole, it is evident that such outstanding issues are indeed soluble in such a way that different states-parties'concerns can be met while still achieving the goal of a protocol that strengthensthe convention. It is simply a display of political will that is neededto go the final distance, and the window of opportunity for completionis indeed now. Already, the protocol is showing signs of being overelaborated and is becoming unnecessarily detailed in some areas, thereby removing flexibility from the future protocol organization. If the negotiationsare not completed within the coming year, there is a real danger that the protocol's provisions will become so corrupted that the resulting regime will be ineffective and inefficient and will fail to meet the objective of strengthening the convention. As Australia noted in March, "Never havethe reasons for concluding the protocol been so acute. Ultimately, thechoice is about the kind of world that we want to live in. ...The wrong choice, or even the right choice made too late, too grudgingly, could bedevastating."

More to the point, a failure to complete the protocol now would send a message to all those contemplating the acquisition of biological weapons that the international community does not care about these weapons. This would reinforce the already confused message providedby the Security Council's failure to take firm action against Iraq's retention of biological weapons-related components. Moreover, given that the 21st century is indeed the age of biotechnology, transfers of biotechnology will bring benefits to states worldwide, but if misused, could cause devastating harm and damage. There is great need for a protocol that can provide substantial transparency in this crucial area. It would be tragic if the world hasto wait until there has been a dramatic demonstration of the damage that biological weapons can achieve for the BWC to be effectively strengthened.


NOTES

1. United Nations SecurityCouncil, "Eighth report of the Secretary-General on the status of the implementationof the plan for the ongoing monitoring and verification of Iraq's compliancewith relevant parts of Section C of Security Council Resolution 687 (1991),"S-1995/864, October 11, 1995, paragraph. 28.

2. A complete protocol textfree from alternative language that sought to introduce realism and tostrike a balance between the different aspirations so as to achieve a worthwhileand valuable protocol that will be acceptable to all states-parties wasdistributed in Geneva in March 2000. Graham S. Pearson, Nicholas A. Sims,Malcolm R. Dando, and Ian R. Kenyon, The BTWC Protocol: Proposed CompleteText for an Integrated Regime. Evaluation Paper No. 17, Universityof Bradford, March 2000. Available on the Web at www.brad.ac.uk/acad/sbtwc.

3. The United Kingdom's 1997annual report on implementation of the CWC shows that 577 plants in 157sites have been declared. Department of Trade and Industry, 1997 AnnualReport on the Operation of the Chemical Weapons Act 1996 by the Secretaryof State for Trade and Industry, Department of Trade and Industry,February 1998.

4. Measures to improve theimplementation of Article III of the BWC are addressed in Graham S. Pearson,The BTWC Protocol: Improving the Implementation of Article III of theConvention, Briefing Paper No. 28, University of Bradford, January2000.

5. See, for example, "TheCWC at the Two-Year Mark: An Interview with Dr. John Gee," Arms ControlToday, April/May 1999; and the Organization for the Prohibition ofChemical Weapons, OPCW Annual Report 1998.


Graham S. Pearson is VisitingProfessor of International Security in the Department of Peace Studiesat the University of Bradford in the United Kingdom. He is author of TheUNSCOM Saga: Chemical and Biological Weapons Non-Proliferation.