Testimony of Barbara Hatch Rosenberg, PhD


Before the Subcommittee on National Security, Veterans Affairs and

International Relations, House Committee on Government Reform


Hearing on The Biological Weapons Convention Protocol:  Status and Implications

June 5, 2001


My thanks to Representative Shays and the Subcommittee for giving me the opportunity to speak for the many expert non-governmental organizations and individuals in this country and elsewhere, the vast majority of whom support the rapid completion of a Protocol to strengthen the Biological Weapons Convention (BWC).


I am Dr. Barbara Hatch Rosenberg, a molecular biologist formerly of Cornell Medical College and now Research Professor at the State University of New York.  I chair the Federation of American Scientists’ (FAS) Working Group on Biological Weapons, a core group of ten professionals with expertise ranging from technical to medical to legal to political, and, in addition, dozens of collaborating consultants on specialized issues.  All of us volunteer our efforts in the hope of contributing to the control of a looming, long-term global threat that is increasing every day along with the explosive growth of knowledge in the biological sciences and technology.


The FAS Working Group has monitored the course of the BWC and contributed to every effort to strengthen it for more than twelve years.  Until quite recently we were the only NGO involved.  Our institutional memory and technical expertise surpasses that of nearly all the Protocol negotiators, who come and go while we stay on with our focus fixed on biological weapons issues.  Our verification credentials derive from a series of trial inspections carried out in the early ‘90s, numerous in-depth discussions with inspectors and inspection agencies such as FDA and UNSCOM, constant research, and a broad acquaintance with most of the actors in the field, including the negotiating teams from many countries.  We have contributed nearly 50 Reports and Working Papers on technical issues to the negotiations and sponsored many seminars and workshops in Geneva for the negotiators.  We have always worked closely with representatives of the pharmaceutical and biotechnology industries and have issued two joint papers with PhRMA representatives.


US Policy and the BWC Protocol


Ever since President Nixon unilaterally renounced biological weapons, there has been bipartisan support for the BWC and, under Ronald Reagan, George Bush (Sr.) and Bill Clinton, vocal US support for strengthening it.  Under the previous Bush Administration, the United States participated in a verification feasibility study known as VEREX (carried out by Verification Experts from the BWC parties), which issued a positive report.  A series of international steps, begun in 1986, have brought us close to the goal of a legally-binding compliance regime for the BWC.


Throughout the six years of Protocol negotiations, however, virtual deadlock in the inter-agency process prevented United States leadership and greatly limited US contributions.  With each agency most interested in protecting its own turf, there has been no participant who has had both the vision and the power to insist on the public interest.  It is one of the weaknesses of our government that these short-sighted bureaucrats have endured and will continue to do so regardless of the Party in power.  Only high-level determination, like that of George Bush (Sr.) to complete and sign the Chemical Weapons Convention, will override these narrow interests.  Informed oversight by the legislative branch could also play an important role.


Consequently, at the Protocol negotiations the ball has been carried by our allies, particularly the United Kingdom, which served as Friend of the Chair for Compliance Measures.  The UK has devoted great effort to research and develop an effective compliance regime.  Their proposals have been applauded by many outside experts.  If the Western Group had stood solidly behind the original British contributions to the rolling text we would have a much stronger Protocol text now.  But US objections forced continual weakening of the text, and the obvious split in the Western Group prevented the West from negotiating from strength with other Blocks.  Countries like China have been able to use the United States as a shield for their views.  Rejection of the Chairman’s Text for the Protocol puts the United States in a position more extreme than that of the radical fringe--China, Libya, Cuba, Iran and Pakistan--which have expressed significant objections but not outright rejection of the text.


The Politics of the Chairman’s Protocol Text


US objections to the strong Protocol measures originally advocated by our allies centered around the declaration of Biological Defense facilities.  This year, new objections were added, including opposition to declaration of non-governmental production facilities.  Once US objections were voiced, it became essentially impossible to reach consensus on anything stronger.  The US positions embolden the likes of China or Cuba to behave similarly.  Incorporation of US demands in his compromise text left the Chairman in a weakened position to deal with the demands of other countries.  Our allies consider the Chairman’s text to be the best that can now be achieved.  At the same time, they consider it the bottom line and want no further compromises.


Moreover, the negotiators are close to the end of their patience and our allies see no point in continuing to spar unproductively with the United States.  We are within reach of the goal.  If consensus cannot be reached soon with minor adjustment of the Chairman’s text, it means that there is no political will to strengthen the BWC.


Endangering the International Norm against Biological Weapons


Unless it can be seen by the end of the remaining four weeks of negotiation that agreement is near, there is sure to be a contentious row at the fifth BWC Review Conference in November, with quite likely a lack of agreement on what to do next.  The United States is certain to receive most of the blame.  We led the chorus in citing the danger; if we turn down an international step toward prevention that is almost within our grasp, it will tell potential proliferators that the international community is not prepared to enforce the ban on biological weapons.  As citizens of the lone superpower, Americans would be a prime target if these weapons were used either strategically or as an instrument of terror. Even without use, the proliferation of biological weapons entails a serious risk of escape and the possible establishment of new and uncontrollable diseases in the biosphere.  There are no military weapons that can “take out” an emerging disease.


Bioterrorism Requires State Sponsorship


US military experts, and studies by many non-governmental experts, agree that, at present and for some time to come, terrorist groups are highly unlikely to have sufficient expertise and resources to succeed in a mass attack with biological weapons.  Aum Shinrikyo, the Japanese terrorist group, had plenty of both but failed in nine attempts to mount a biological attack.  Although the United States has so far concentrated on preparations for mopping up after a bioterrorist disaster, it would be foolhardy to ignore the more important goal of cutting off the source by preventing the proliferation of biological weapons.  That is not something the United States can do unilaterally.  The first step must be international, and strengthening the BWC is the available tool.  That is why our European and other allies are so angered and dismayed by the US stance.


What the Protocol Could Do


A verification regime that can be relied upon to detect violations of the BWC is impossible.  That is not what the Protocol is about, and not what the negotiators have ever tried to do.  Too much of what is needed to develop biological weapons also has peaceful uses.  In such “dual-use” situations, the objective is transparency with regard to relevant capabilities.[1]  This was an intrinsic premise in the VEREX feasibility study and its positive outcome.


Sufficient transparency can be achieved by requiring declaration of relevant installations and providing means for clarifying any questions that may arise regarding the declarations, including whether or not relevant sites have NOT been declared.  The Chairman’s text does this.  It requires declaration of the sites of greatest potential threat, and it provides several different means for getting on site (which, if blocked by the party in question, would also yield information). 


The intrinsic tension between transparency and confidentiality means that, in any biological weapons regime, no smoking guns are likely to be found.  Although inspectors’ on-site activities have to be subject to limits in order to protect confidential information, that doesn’t mean that nothing will be learned.  In Iraq, UNSCOM inspectors met with great difficulties in obtaining hard proof, but they were adept at spotting inconsistencies with the stated purpose of a site and they quickly recognized what questions needed to be answered.  Raising suspicions, or resolving them, is what the Protocol is about.  National means can then be focused on the sites or questions of concern.  The Protocol’s compliance regime would effectively complement national intelligence, military power and diplomacy.  In serious situations the Protocol would provide a basis, broader than we now have, for international action.


The Chairman's text provides a variety of on-site measures:


Douglas MacEachin, former Deputy Director of the CIA, has made a persuasive case for the deterrent effect of non-challenge visits.  In a recent article he points out that, ideally, a proliferator would use a commercial plant as a cover for a biological weapons program, thereby facilitating operations and the procurement of dual-use equipment and materials.  But if the plant had to be declared, he would not take the chance that inspectors might obtain enough information during a visit to raise new suspicions.  Instead, the illicit activity would be forced into undeclared, clandestine operation, with all the attendant risks.  Any evidence of suspicious activity at an undeclared site could lead to intense surveillance, a clarification process under the Protocol or a challenge investigation. 


The Chairman's Protocol text calls for a 50% vote of Executive Council members present and voting to authorize a challenge investigation at a suspected facility.  An FAS study recommended this formula as the best means for preventing ill-founded investigations without unduly inhibiting the use of this important measure or impeding its deterrent effect.  Although challenge investigations have political costs and will not be used often, it is likely that, had the Protocol been in existence, the political situations would have permitted the invocation of challenge investigations in past cases where allegations eventually proved to be true, such as the anthrax outbreak at Sverdlovsk in 1979.  A challenge at that time would have forced the Soviet Union to flout the terms of the treaty and refuse access.  That might have had a dampening effect on their subsequent biological weapons build-up. 


It is ironic that, while suspecting Iraq of continuing its biological weapons program and decrying its refusal to allow UN inspections, the United States is poised to turn down a treaty that would provide a variety of means for probing suspicious installations by going on site.


The US Critique of the Protocol


The US policy review has rejected the Chairman's text on the grounds that

a)  it is too weak,

b)  it would threaten national security and commercial proprietary information, and

c) it threatens the Australia Group and its “dual use” export control regime.


a)  Weakness: 

With regard to weakness of the text,  the old argument of not being able to detect violations (meaning always, and with certainty) is frequently invoked.  As discussed already, this is not and could not possibly be the purpose of the Protocol.  If this were the only criterion of interest to the United States, we should never have participated in the negotiations in the first place.


Furthermore, the US delegation has made it known in Geneva that they will not support any Protocol based on the present negotiation mandate, but would prefer a much more limited mandate—which would inevitably lead to a more limited Protocol.  A more limited Protocol--say, containing only challenge investigations--would be weaker, not stronger.


Finally, the weaknesses in the text are largely there in compliance with past US demands, including the following:

--The text does not require declaration of all biodefense facilities; only those conducting certain activities, and only those above a certain size.  There are ample loopholes to satisfy DoD specifications.

--The text requires no significant information about production facilities for pharmaceuticals (other than licensed vaccines), and exempts them from visits!  No problem there for American pharmaceutical companies.

--All on-site activities of inspectors during visits are at the discretion of the host government, and all procedures during challenge investigations are subject to managed access.

--All visits require at least two weeks notice.


FAS has advocated stronger measures than these, but we recognize the necessity for compromise and the role played by the United States in shaping those compromises.  Any American who criticizes the Chairman's text for being too weak has to be either disingenuous or ignorant of the political situation.


b)  Confidentiality: 

The Chairman's text possesses more safeguards for confidential information than the Chemical Weapons Convention of 1993 (CWC), to which we are already a party and which covers most of the same facilities:  those handling toxins (including the US biodefense program), for example, fall under both treaties; most pharmaceuticals are manufactured chemically, and therefore are "discrete organic chemicals" covered by the CWC.   And challenge inspections under the CWC can take place "anytime, anywhere," as President George Bush (senior) insisted. 


Unlike the CWC, for example, the Protocol text allows no sampling and analysis in non-challenge visits, and  gives control of access to the host country.  These aspects of the Protocol text comply with the wishes of US bioindustry, which is particularly concerned about protecting its proprietary microbial strains.  There are, in addition, all the protections for confidentiality that were developed for the CWC with the help of the chemical industry.  The exemption of certain defense facilities and of most pharmaceutical facilities from declaration under the Protocol, discussed above, provides additional protections for confidential information.


The Chairman's text more than meets all the essential confidentiality concerns of the pharmaceutical and biotech industries.  Further safeguards for industry could be incorporated into US Protocol implementing legislation, and, when the time comes, we and our industry colleagues will be happy to work with the members of this Subcommittee to help develop appropriate implementation measures.


c)  Export Controls

One only need read Article 7 of the Chairman’s text to realize that its rhetoric is meant to please the critics of the Australia Group but its substance tilts heavily toward the West.  The text contains only guidelines,with no hard obligations regarding exports; each State Party has full discretion over implementation of the suggestions in the text.


On-site Trials as a Basis for the Protocol


One thing is certain:  any weaknesses in the Protocol do not stem from inadequate technical information.  Although the United States has submitted no reports on trial visits or investigations to the Protocol negotiations, twelve trial visits have been reported by other countries, most of them US allies (See appended table).  Half of these trials involved more than one country, or included foreign observers.  All of them concluded that non-challenge visits would be effective in  strengthening the BWC and increasing confidence in compliance.  They also concluded that confidential information could be protected at the same time.  Americans should be aware that protection of their defense establishments and bio-industry is of great importance to our allies, as it is to us.  In formulating their policies our allies have worked productively with the same multinational corporations that are the major players in the United States.


In addition, copious amounts of information were available from trial inspections conducted by the United States and many other countries not so long ago during negotiation of the CWC, from the UNSCOM experience in Iraq, and from the experience of multiple types of national and international inspections carried out routinely at sites relevant to the Protocol by many countries. 


It would be desirable for the United States to carry out on-site trials of its own in order to allay the fears of those potentially affected, but to be credible at this stage, such trials would have to be multilateral and would have to make a special effort to demonstrate the absence of bias. 


Additional Mechanisms for Controlling Biological Weapons


1.  Global Surveillance and Control of Emerging Diseases

Article X of the BWC requires scientific/technological cooperation for the prevention of disease and other peaceful purposes.  The negotiators of the Protocol recognize that this promise must be implemented in a specific way in the Protocol.  A set of goals has been fully agreed by the negotiators and is contained in the Chairman's text;  most of these concern surveillance, detection, diagnosis, and control of infectious diseases.  The World Health Organization and several other health organizations have formed an Alliance Against Infectious Diseases (AllAID) that has proposed a specific mechanism for accomplishing the cooperative aims of the Protocol.  The proposed program, to be funded by Protocol parties, would establish a network of about ten regional epidemiological/diagnostic Centers, strategically located in  the developing world.   Each Center  would establish its own regional network and provide  training in outbreak recognition and control.  Advanced training and research on regional disease problems would also be supported.  The program has a two-fold aim:  regional self-sufficiency in handling infectious diseases, and global early warning of emerging diseases.  This program would serve as an important incentive for adherence to the Protocol, while at the same time providing a means for speeding the recognition and control of any use or escape of biological weapons.  When the program is in full force it will have the effect of deterring the use or testing of biological weapons by strengthening the capacity of all regions, especially those that are now the weakest, to recognize or diagnose unusual outbreaks.


2. Ethical Education of Biological Scientists

Few bioscientists anywhere now emerge from their formal academic training with an understanding of the dilemmas their future work may pose.  Subsequent immersion in their professional specialties often leads to a bias against considering any potential negative aspects, lest research be restricted in some way.  There is little or no awareness of international concerns and prohibitions on the misuse of biology.  The development of appropriate courses and educational materials that could be widely used is desperately needed.


The Federation of American Scientists has initiated a collaborative project to develop a collection of cutting-edge web-based materials that could stand alone as a course or be incorporated in existing courses at universities around the world.  The project, entitled “The Biological Sciences:  Risks, Responses and Responsibilities,” will involve contributors from many countries.


3.  International Self-Monitoring of Bioscience

A number of organizations are now studying possible non-governmental means for ensuring transparency and establishing some form of oversight on work with pathogens and other biologically-active materials.  It is too early to discuss or predict the outcome of these efforts.

Trial Visits


Official Reports to the Ad Hoc Group


*  Working Paper concludes visit is potentially useful

#  Working Paper concludes confidential information can be protected




Working Paper

Submitted by

Type of Facility

Inspectors and Observers

Session 21 Working Papers (BWC/AD HOC GROUP 54)

Practice randomly-selected transparency visit to a biodefence facility



13 December 2000

* #


Biodefence Facility

Australian team

Session 19 Working Papers (BWC/AD HOC GROUP 51)

Report on a trial transparency visit to a biological defensive facility



17 March 2000

* #


Biodefence Facility

Spanish team (Ministries of Foreign Affairs, Health Education and Defence)

Session 16 Working Papers (BWC/AD HOC GROUP 47)

Report on two trial visits based on a transparency visit concept



24 August 1999

* #


Industrial Production Facility

German team and a visiting team consisting of three people from three other States Parties

Session 15 Working Papers (BWC/AD HOC GROUP 46)

Report on a Trial Inspection (Random visit)



10 June 1999

* #


Industrial Production Facility

Swiss team and a representative of the Ministry of Defence in Austria

Session 13 Working Papers (BWC/AD HOC GROUP 44)

Report of a National Trial Visit to a Vaccine and Serum Production Facility



14 January 1999

* #

Islamic Republic of Iran

Vaccine and Serum Production Facility

Iranian team

Session 12 Working Papers (BWC/AD HOC GROUP 43)

Report on an international trial random visit



23 September 1998

* #


Pharmaceutical Facility

Austrian team and visiting team consisting of four representatives from Japan, Germany and Switzerland

Session 12 Working Papers (BWC/AD HOC GROUP 43)

Report of a trial random visit to a biopharmaceutical production facility



21 August 1998

* #

Denmark, Finland, Iceland, Norway and Sweden

Biopharmaceutical Production Facility

Home team (government representatives, technical experts and representatives of the facility) and a visiting team consisting of five persons from three other countries

Session 9 Working Papers (BWC/AD HOC GROUP 39)

Report of a visit to a Pharmaceutical Research Facility



09 January 1998

* #

United Kingdom

Pharmaceutical Research Facility

Home team

Session 9 Working Papers (BWC/AD HOC GROUP 39)

Use of a simulated declaration format in a practice visit



17 December 1997


United Kingdom

Industrial Facility

Home team

Session 4 Working Papers (BWC/AD HOC GROUP 31)

Trial inspection of a biological production facility



18 July 1996

* #


Biological Production Facility

Australian inspection team

Session 4 Working Papers (BWC/AD HOC GROUP 31)

Report of a joint UK/Brazil practice non-challenge visit



18 July 1996

* #

Brazil and the United Kingdom

Vaccine and Serum Production Facility

Brazilian and UK teams and an additional representative of PAHO (Pan American Health Organization)









[1] Novices often assume that "transparency" means divulging exactly what is going on in a facility.  That is not the case.  It is the facility's capabilities that must be revealed.   Experienced inspectors can then judge whether those capabilities make sense for peaceful purposes and are consistent with the alleged purpose of the facility.