WRITTEN TESTIMONY

OF

PROFESSOR GRAHAM S. PEARSON

VISITING PROFESSOR OF INTERNATIONAL SECURITY

DEPARTMENT OF PEACE STUDIES

UNIVERSITY OF BRADFORD

BRADFORD, WEST YORKSHIRE, UNITED KINGDOM

AND PREVIOUSLY

DIRECTOR GENERAL AND CHIEF EXECUTIVE

CHEMICAL AND BIOLOGICAL DEFENCE ESTABLISHMENT

MINISTRY OF DEFENCE

PORTON DOWN, SALISBURY, WILTSHIRE, UNITED KINGDOM

TO THE SUBCOMMITTEE ON NATIONAL SECURITY,

VETERAN AFFAIRS & INTERNATIONAL RELATIONS

OF THE COMMITTEE ON GOVERNMENT REFORM

Washington, D.C.

10 July 2001

EXECUTIVE SUMMARY

*********

This testimony starts by examining the development of the Protocol showing how it has developed from the Confidence-Building Measures agreed at the Second Review Conference in 1986 and extended at the Third Review Conference in 1991 through the considerations by VEREX in 1992 and 1993 leading to the establishment of the Ad Hoc Group in 1994 and its subsequent negotiations.

It goes on to address the value of the composite Protocol text by making comparisons, first between the Biological and Toxin Weapons Convention (BTWC) with its Protocol regime and the BTWC alone, and then between the BTWC with its Protocol regime and the Chemical Weapons Convention (CWC) regime, given that both Conventions overlap -- and rightly so -- in the areas of toxins, bioregulators and peptides. The comparison with the BTWC alone shows that the Protocol brings significant and worthwhile benefits to all States Parties whilst the comparison with the CWC shows that in respect of the monitoring of dual-purpose materials and facilities, the two regimes are very comparable, with the Protocol regime imposing a less onerous but more focussed burden in respect of declarations and visits whilst the international cooperation provisions are much more extensive than those of the CWC.

Attention is then paid to a number of key issues:

a. The Effectiveness of the Protocol

b. Export Controls

c. The Burden of the Protocol

d. Industry Concerns

e. Additional Mechanisms under Discussion

f. Other International Monitoring Systems

g. More time needed?

In the final section, a tabular comparison is made between the costs and gains of signing the composite Protocol text and rejecting the composite Protocol. This leads to the conclusions that:

a. In signing the composite Protocol text, the US will be seen to have continued in its leadership role and having taken all possible multilateral steps to prevent biological weapons.

b. Signing the composite Protocol text will reduce the risk of biological weapons proliferation and use. Rejection of the Protocol would send the opposite signal and it can be argued that the risk of biological weapons proliferation and use will be increased.

c. Overall, signing the composite Protocol text enhances US security. It provides a net gain to US security. Rejection of the Protocol misses this opportunity and decreases US security.

Mr Chairman and members of the Subcommittee. It is an honour and a pleasure to be invited to submit written testimony on the “Biological Weapons Convention Protocol: Status and Implications”.

I am Dr Graham S. Pearson, a Visiting Professor of International Security in the Department of Peace Studies of the University of Bradford in the United Kingdom. I was previously, from 1984 to 1995 when I reached the mandatory retirement age in the British Civil Service, the Director General and Chief Executive of the Chemical and Biological Defence Establishment of the United Kingdom Ministry of Defence at Porton Down, the oldest chemical and biological defence establishment in the world established in 1916.

During my time as Director-General at Porton Down, I was responsible for changing the name of the establishment from the Chemical Defence Establishment to the Chemical and Biological Defence Establishment reflecting the increased attention and effort paid to biological defence from 1986 onwards. I was responsible for the contributions of the Chemical and Biological Defence Establishment during the Gulf War of 1990/91 to ensuring that the Armed Forces of the United Kingdom were protected against the threat that Saddam Hussein might use chemical or biological weapons against them.

I was also a member of the UK delegation to the VEREX group identifying and evaluating potential verification measures in Geneva in 1992 and 1993: I served as the rapporteur to VEREX for “measures in combination”. I was also a member of the UK delegation to the Ad Hoc Group prior to my retirement in 1995 and for a short period in 1995, I served as the Assistant Chief Scientific Adviser (Non-Proliferation) in the headquarters of the United Kingdom Ministry of Defence.

Since my retirement from the Ministry of Defence in 1995, I sought and was awarded a John D. and Catherine T. MacArthur Foundation grant for Research and Writing which enabled me to write a book “The UNSCOM Saga: Chemical and Biological Non-Proliferation” published in May 2000 by St. Martin’s Press. In this I have examined the work of UNSCOM in respect of chemical and biological weapons in order to extract the lessons for chemical and biological weapons non-proliferation.

My principal activity over the past five years, which is currently financed by a grant from the Carnegie Corporation of New York, has, however, been to closely follow the negotiations in the Ad Hoc Group of a Protocol to strengthen the effectiveness and improve the implementation of the Biological and Toxin Weapons Convention. In this context, I have written or edited over 30 Briefing Papers and 20 Evaluation Papers which have been presented and distributed to the delegations engaged in the Ad Hoc Group negotiations in Geneva. I have visited Geneva to make these presentations to each session of the Ad Hoc Group and also to discuss with representatives of delegations the progress of the negotiations. I have consequently followed the negotiations and the developments in the Ad Hoc Group more closely than anyone else who is not a member of a delegation. I have written quarterly progress reports over the past four years on the negotiations which have been published in The CBW Conventions Bulletin.

In my written testimony to the Subcommittee, I am therefore drawing upon my experience as Director General and Chief Executive of the Chemical and Biological Defence Establishment, Porton Down where I was responsible for over ten years for the United Kingdom research and development programme in chemical and biological defence, my detailed study and analysis of the work of UNSCOM in uncovering the Iraqi chemical and biological weapons programmes and my close involvement over the past decade, both within government and then outside government, in the negotiations first in VEREX and then in the Ad Hoc Group to strengthen the regime to prevent biological weapons.

The Development of the Protocol

The Biological and Toxin Weapons Convention (BTWC) was opened for signature in 1972 and entered into force in 1975. This totally prohibits the development, production, storage or acquisition of biological weapons and was the first international treaty to totally ban an entire class of weapons. This Convention has established an international norm that biological weapons are totally prohibited to which over 160 States have bound themselves -- 143 States Parties and 18 Signatory States. The United States together with the United Kingdom and the then Soviet Union are the co-Depositaries of the Convention which reflected an initiative by both the United States and the United Kingdom to ensure that biological weapons are totally banned.

It has, however, become increasingly clear over the past 25 years that the absence of an organization and of measures to demonstrate compliance and address non-compliance concerns is resulting in an erosion of confidence in the effectiveness of the Convention. This was highlighted by the admission in 1992 that the former Soviet Union, despite being a co-Depositary, had continued a massive offensive biological weapons programme until at least 1992. Further concerns about the Convention were underlined when the United States at the Fourth Review Conference in 1996 stated that twice as many states were currently seeking or had already obtained biological weapons than when the Convention entered into force in 1975.

The Convention, however, has no provisions for verification -- other than to take compliance concerns to the Security Council (which has not happened during the past 26 years) or for the monitoring of compliance. The developments in the 1970s and 1980s including the release of anthrax at Sverdlovsk (now Ekatinerburg) in 1980 and the advances in genetic engineering and biotechnology led the States Parties to the Biological and Toxin Weapons Convention at the Second Review Conference in 1986 to agree four politically binding Confidence Building Measures. These were extended and a further three Confidence Building Measures agreed at the Third Review Conference in 1991. As these Confidence Building Measures were not amended at the Fourth Review Conference in 1996, they have since 1991 been as follows:

* A simplified proforma on which to indicate "Nothing to declare" or "Nothing new to declare"

1. The exchange of data on research centres and laboratories (CBM A, Part 1 & Part 2), extended to include information on biological defence programmes and activities

2. The exchange of information on outbreaks of disease and similar occurrences caused by toxins (CBM B)

3. The encouragement of publication of results and promotion of use of knowledge (CBM C)

4. The active promotion of contacts (CBM D)together with the three new confidence-building measures added in 1991:

5. Declaration of legislation, regulations and other measures (CBM E),

6. Declaration of past activities in offensive and/or defensive biological research and development programmes (CBM F), and

7. Declaration of vaccine production facilities (CBM G).

It has, however, become apparent that these Confidence Building Measures are of strictly limited value as the data submitted by the States Parties has been patchy and variable. Just over one half of all the States Parties have made a single submission and only about 11 have made the required annual submissions. The submissions are simply collated as and when they are received and circulated to the States Parties. They are not translated into the UN languages and there is no analysis of the information provided. In sum, they do not achieve their objective of building confidence because of the variability between States Parties as to what is considered appropriate to be submitted and the absence of any means of either seeking missing submissions or clarifying any uncertainties or ambiguities in the submissions.

At the Third Review Conference in 1991 following the Gulf War of 1990/91 and the changes in the Soviet Union and the Warsaw pact, the States Parties agreed to establish an Ad Hoc Group of Governmental Experts (known as VEREX) “to identify and examine potential verification measures from a scientific and technical viewpoint”. VEREX met twice in both 1992 and 1993 producing a Final Report evaluating 21 off-site and on-site measures. This report was considered by a Special Conference in September 1994 which established an Ad Hoc Group to consider appropriate measures, including possible verification measures, and draft proposals to strengthen the Convention, to be included, as appropriate, in a legally binding instrument.

The Ad Hoc Group first met in January 1995 and by the time of the last Ad Hoc Group session in April/May 2001 had held 23 sessions. Initially, Friends of the Chair (FOCs) examined issues such as compliance measures, definitions and objective criteria, confidence building measures and measures related to Article X of the Convention on international cooperation and technical exchange. It is worth recalling now precisely what the mandate of the Ad Hoc Group said about compliance measures:

- A system of measures to promote compliance with the Convention, including, as appropriate, measures identified, examined and evaluated in the VEREX Report. Such measures should apply to all relevant facilities and activities, be reliable, cost effective, non-discriminatory and as non-intrusive as possible, consistent with the effective implementation of the system and should not lead to abuse;

It is thus clear that the mandate agreed by all States Parties is for a system of measures to promote compliance with the Convention. During the initial Ad Hoc Group sessions, the FOCs chaired sessions addressing their particular areas of responsibility and produced papers that reflected the discussions that had taken place yet were without prejudice to the positions of delegations on the issues under consideration in the AHG and did not imply agreement on the scope or content of the paper. However, these FOC papers were considered by the Ad Hoc Group in plenary session and amended as requested by delegations so that they reflect the views expressed before they are accepted for attachment to the procedural reports of the meetings. It is also clear from the reports of the meetings that some FOC papers have gone through several iterations and have thus been refined and improved.

In July 1997, the Ad Hoc Group successfully transitioned to consideration of a rolling text of a draft Protocol in which square brackets were used to indicate alternative forms of language. This has now reached its sixteenth version. As might be expected, the number of square brackets has passed through a peak and has subsequently decreased as the language for a number of Articles satisfactorily met the requirements of States Parties and became free from square brackets. The remaining issues were, however, ones which could not be resolved in meetings chaired by individual Friends of the Chair and by mid 2000, the reduction in the number of square brackets had reached stagnation.

This led the Chairman, Ambassador Tibor Tóth, in mid 2000 to commence a series of extensive and intensive bilateral consultations with delegations and with Friends of the Chair in order to explore conceptual solutions to the outstanding issues. Following these consultations the Chairman provided written elements in a stripped down form of text which contained some ideas which might form the basis of a compromise in some of the areas where there were differing views. By the end of the February 2001 Ad Hoc Group session written elements had been provided for almost the whole of the Protocol. The stripped down text used in these written elements could not be readily compared with the rolling text and therefore forced a de novo consideration of the conceptual solutions identified by Ambassador Tóth in his bilateral consultations. This led in the February 2001 Ad Hoc Group session to calls by a number of States Parties for the provision of a complete text.

On 30th March 2001, in capitals as well as in Geneva, Ambassador Tóth provided the States Parties with the Chairman’s composite Protocol text that is in its entirety based on language in the rolling text and incorporating compromises where necessary to strike a balance in those parts of the text where differing views still remained. It is important to stress that this composite text was based in very large measure on text that had already been agreed by all delegations during the negotiations, including the United States. At the 23rd session of the Ad Hoc Group in April/May 2001, Ambassador Tibor Tóth provided detailed explanations on an Article by Article basis of the compromises which were significant for delegations.

Ambassador Tóth in his press conference at the end of the 23rd Ad Hoc Group session on 11 May 2001 said that the States Parties at the Ad Hoc Group had welcomed the provision of the Chairman’s composite Protocol text. In their view it demonstrated that it was possible to meet the mandate of the Ad Hoc group to complete the Protocol by the Fifth Review Conference in November/December 2001. He went on to say that quite a number of delegations had welcomed the balance of compromises although, as might be expected from the nature of compromises, there were delegations who were unhappy with the compromises. He said that:

“What was emerging as a climate in the negotiations was that the delegations which used to form a silent majority in the negotiations had spoken massively in the course of the session. They spoke in favour of the fulfilment of the mandate and concluding the negotiations in the next session. … the question was whether delegations and capitals participating in these negotiations for practically seven plus three years would say yes or no to a Protocol, which in his judgement, would respect legitimate bio-defense, industrial and non-proliferation interests while providing for efficient, additional tools to strengthen the Biological Weapons Convention.”

The Value of the Protocol

The Chairman’s composite Protocol text is firmly based on the rolling text – indeed over 99% is identical to language in the rolling text – in which compromises have been adopted where necessary. . A detailed evaluation[1], Article by Article, of the Chairman’s composite Protocol text prepared by Graham Pearson, Malcolm Dando[2] and Nicholas Sims[3] and distributed to the delegations to the Ad Hoc Group in April 2001 concluded that "Whilst these compromises will not satisfy the aspirations of all the delegations to the Ad Hoc Group, they do, in our view, successfully ensure that the composite Protocol text achieves its mandate of strengthening the effectiveness and improving the implementation of the Convention. The composite Protocol text has successfully retained all the essential elements for an effective Protocol ranging from definitions and objective criteria, through compliance measures to measures for scientific and technological exchange for peaceful purposes and technical cooperation." [Emphasis added]

It is critically important to consider what is actually in the Chairman’s composite text and not to comment, as several testimonies have, on misperceptions based on incorrect or dated appreciations; the terminology used in several testimonies indicates a failure to read or study the Chairman’s composite Protocol text. It has also to be recognized that the Protocol negotiations have seen the evolution of a text that reflects the inputs of the negotiators and the strengths and validity of the arguments put forward. It is, however, true that the elements identified in the first version of the rolling text in mid-1997 are all still there in the Chairman’s composite Protocol text. It is the detail that has been developed and refined in the light of the negotiations.

It is now timely and necessary after years of detailed negotiation about words and paragraphs in the Articles to stand back and examine the Chairman’s composite Protocol text as a whole in order to consider its value. It is also necessary to recognize that what has been negotiated is a Protocol to strengthen the effectiveness and improve the implementation of the Convention – it is not and never has been a “verification” Protocol. Rather its whole thrust has been to focus on compliance – to increase transparency as well as the quantity and quality of information about activities and facilities within States Parties of particular relevance to the Convention. Over time this transparency will help to build confidence between States Parties that they are in compliance with the Convention. Whilst the Protocol could have been stronger, it has to be recognized that stronger measures would not have attracted wide support and that the composite Protocol text is the best that can be negotiated at this time. A further period of negotiation would not strengthen the composite Protocol text and could well lead to unravelling of what is already a good Protocol. In standing back to examine the Protocol, a useful analogy is to a tree where the Ad Hoc Group have been considering which way the branches will go and what the shape of the leaves should be. It is now time to consider the whole tree.

In considering the Chairman’s composite Protocol text, it is important to remember that the BTWC with its basic prohibitions and obligations has been in force for over 25 years and that the Protocol is to strengthen the effectiveness and improve the implementation of the Convention. The Protocol makes no changes to the basic prohibitions and obligations. The Protocol regime is supplementary and additional to the Convention. It does not undermine the prohibitions in Article I, but rather the Protocol safeguards Article I -- a long standing objective of the United States and other delegations.

The key comparison is thus between the BTWC Protocol regime and the BTWC alone (including the procedures devolved from its provisions). A tabulation of the principal measures in the regime, compared with the procedures of the BTWC alone, clearly brings out the significant benefits from the Protocol.

Table 1. Comparison of the Convention and its Protocol Regime with the Convention alone

BTWC and its Protocol Regime	BTWC alone
Mandatory declarations -- measures to ensure submission	Confidence-Building Measures -- patchy and variable (if made)
Declaration follow-up procedures -- analysis of declarations -- randomly-selected transparency visits	None -- none -- none
Declaration clarification procedures -- clarification visits	None -- none
Voluntary assistance visits	None
Non-compliance concerns -- Consultations >>> Investigations	Art V consultation procedures Art VI complaint to UN Security Council
Field investigation	Possible UN Secretary-General investigation if invited by State Party concerned
Facility investigation	None
Transfer procedures	None
Assistance -- provisions detailed	Art VII assistance if UN Security Council decides a Party has been exposed to danger
International Cooperation -- elaborated in detail -- Cooperation Committee	Art X provisions -- no implementation procedures -- none
Organization -- CoSP, ExC & Technical Secretariat	None
National implementation -- Penal legislation required -- National Authority	Art IV National implementation -- No penal legislation requirement -- None

Considering all the elements that make up the BTWC Protocol regime as a whole, it is clear that there are overall three particularly significant benefits that will accrue from the BTWC Protocol regime and which are not available with the Convention alone:

Table 2: Principal benefits from the BTWC and its Protocol Regime compared to the BTWC alone.

BTWC and its Protocol Regime	BTWC alone
Measures to increase transparency and build confidence	Suspicions not addressed -- and over time reduce international confidence in the regime
Procedures to address non-compliance concerns	Art V consultations (no teeth) Art VI complaints to UN SC (not used)
International cooperation and assistance provisions enhancing infrastructure, transparency and building confidence	No action despite aspirations at successive Review Conferences

The above comparisons show that the Protocol regime brings significant and worthwhile benefits to all States Parties -- both developed and developing -- over and above the provisions to uphold the basic prohibitions and obligations of the BTWC, which remain unchanged. In addition, the Protocol will be effective, over time, in building confidence between States Parties that other States Parties are indeed in compliance with the Convention, thereby reinforcing the norm that work on biological weapons, whether directed against humans, animals or plants, is totally prohibited. The international cooperation and assistance provisions address a genuine need to counter outbreaks of disease and through improvements in infrastructure in areas such as biosafety and good manufacturing practice to meet internationally accepted standards bring benefits for health and safety as well as for prosperity. The Protocol as a whole thus brings improved health, safety, security and prosperity to all States Parties.

It is also appropriate to compare the BTWC Protocol regime with the CWC regime -- both Conventions address toxins, bioregulators and peptides and thus rightly have a significant area of overlap, both have general purpose criteria which embrace all possible agents, past, present and future, and both address dual use materials and technology.

The CWC regime is the one of greatest relevance to the BTWC Protocol regime and it is already evident that National Authorities for the two regimes are likely to be colocated in a number of countries.

It is hardly surprising that the BTWC Protocol regime has adopted some concepts where appropriate from the CWC regime. The Protocol is, however, much more elaborated than the CWC and has been finely tailored to address the fundamental difference in the nature of biological agents as well as to capture the facilities of greatest relevance to the Convention. If we ignore the chemical weapon and chemical weapon production facility elements[4] of the CWC, then the basic architecture of the BTWC Protocol regime and the CWC regime is the same. The qualitative differences between the regimes are in the detail: the BTWC Protocol regime has built on the confidence-building measures agreed by the States Parties including the United States at the Second Review Conference in 1986 and extended at the Third Review Conference in 1991. In respect of the monitoring of dual-purpose materials and facilities, the two regimes are very comparable, with the Protocol regime imposing a less onerous but more focussed burden in respect of declarations and visits whilst the international cooperation provisions are much more extensive than those of the CWC.

Table 3. Comparison of the BTWC and its Protocol Regime with that of the CWC

BTWC and its Protocol Regime	CWC Regime
Mandatory declarations -- range of facilities (BL-4, BL-3*, work with listed agents*, production, …) -- requires declaration of biological defence -- measures to ensure submission	Mandatory declarations -- focussed on chemical production facilities -- no declarations yet of chemical defence -- no measures to ensure submission
Declaration follow-up procedures -- explicit and structured -- analysis of declarations -- randomly-selected transparency visits	Declaration follow-up procedures --implicit and unstructured -- routine inspections of production facilities for scheduled chemicals and DOCs (discrete organic chemical)
Declaration clarification procedures -- clarification visits	No declaration clarification procedures -- implicit not elaborated
Voluntary assistance visits	No provision for voluntary assistance visits -- implicit not elaborated
Non-compliance concerns -- Consultations >>> Investigations	Non-compliance concerns -- Consultations >>> Investigations

BTWC and its Protocol Regime	CWC Regime
Field investigation -- includes investigation of releases	Investigation of alleged use -- no investigation of other releases
Facility investigation -- team size and duration limited	Challenge inspection -- duration limited
Transfer procedures	Transfer controls
Assistance -- provisions similar to CWC	Assistance
International Cooperation -- elaborated in detail -- Cooperation Committee --targeted on genuine need to counter disease -- real benefits over time >>health, prosperity	International Cooperation -- not elaborated in detail -- no provision for Cooperation Committee
Organization -- CoSP, ExC & Technical Secretariat -- TS has role to analyse epidemiological info	Organization -- CoSP, ExC & Technical Secretariat -- no parallel role
Confidentiality Provisions -- elaborated in detail in Article and Annex	Confidentiality Provisions -- no Article but an Annex -- not as elaborated
National implementation -- Penal legislation required -- National Authority	National implementation -- Penal legislation required -- National Authority

* Indicates that only selected facilities meeting certain combinations of conditions, not all such facilities are to be declared.

This comparison demonstrates that the two regimes are indeed comparable and effective. Indeed, the quality of the Protocol regime is certainly as good as, if not better than, that of the CWC. Both address dual purpose materials and technologies. Lessons have been learned from the CWC implementation experience. The Protocol text has successfully been crafted so that it will achieve the requirement for an effective and reliable regime which, in accordance with the AHG mandate, will strengthen the effectiveness and improve the implementation of the BTWC and thereby strengthen the norm against biological weapons. There is no doubt that the value of the Protocol will be of immense value to all States Parties -- both developed and developing – bringing improved health, safety, security and prosperity. Indeed it should be noted that there is a relationship between the co-operative measures and international security: improving the international community’s ability to deal with the consequences of infectious disease will help make it easier to identify deliberate outbreaks of disease that are the result of the use of biological weapons. National improvements in biosafety, good manufacturing practice and the regulations covering the handling, transportation and use of biological agents and toxins through the Protocol cooperation measures will improve national infrastructure as well as transparency and over time will contribute to building confidence.

The Protocol is also important for its contribution to the web of deterrence which comprises:

• A strong international and national prohibition regime reinforcing the norm that biological weapons are totally prohibited

• Broad international and national controls on the handling, storage, use and transfer of dangerous pathogens

• Preparedness including both active and passive protective measures and response plans that have been exercised

• Determined national and international response to any use or threat of use of biological weapons ranging from diplomatic sanctions through to armed intervention,

which are together mutually reinforcing and lead a would-be possessor, whether a "rogue State" or a non-State actor to judge that acquisition and use of BW would not be valuable, would be detected and incur an unacceptable penalty. Any single element of the web of deterrence alone is insufficient -- all elements are vital and all need to be strengthened as they thereby reinforce the deterrent effect. The Protocol through its strengthening of the international prohibition regime not only reinforces the norm that biological weapons are totally prohibited. Its requirements also strengthen the international and national controls on the handling, storage, use and transfer of dangerous pathogens and the determined international response to any use or threat of use of biological weapons.

The States Parties to the Protocol will over time gain confidence in the compliance of the other States Parties and any State Party contemplating breaching the Convention will be deterred through the prospect that such a breach will be detected by the measures in the Protocol. Increasingly, States not Party to the Protocol will be isolated and will effectively be declaring themselves as rogue states -- who can be countered better by the multilateral body of the States Parties to the Protocol.

The Issues

The Effectiveness of the Protocol

The aim of the Protocol throughout has been to create a package of measures that will increase transparency and build confidence between States Parties that they are in compliance with the Convention. It is a compliance Protocol not a verification Protocol – it is misleading to suggest otherwise. The heart of the Protocol is thus made up of mandatory declarations, the declaration follow-up procedures and the provisions for investigations. A balance has necessarily to be struck as to which facilities are to be declared: the Protocol declaration triggers embrace a wide range of the facilities and activities of most relevance to the Convention:

a. Biodefence programmes and facilities.

b. Maximum biological containment facilities

c. High biological containment facilities engaged in certain specified production or genetic modification activities

d. Plant pathogen containment facilities over a particular floor area

e. Work with listed agents and/or toxins of a particular character: production above a certain capacity; genetic modification activities; and intentional aerosolisation

f. Production facilities in excess of certain capacities or producing human or animal vaccines.

The scope of the facilities to be declared is thus much broader than those required to be declared under the comparable elements of the CWC. The CWC declarations primarily address chemical production facilities and have yet to include agreed modalities, as required under Article X of the CWC, for declarations of chemical defence programmes or facilities required under Article X of the CWC. Furthermore, the Protocol has provisions to help ensure submissions of declarations – provisions that have no parallels in the CWC, with a variety of tiered penalties, some automatic and some after consideration – should declarations fail to be submitted.

Those who argue that the CWC regime is not relevant to considerations of the BTWC Protocol regime are ignoring the fact that both regimes address dual-use materials and technology, both have general purpose criteria in the basic prohibition which ensures that past, present and future agents are all covered and both cover the prohibition of toxins, bioregulators and peptides. It is evident that the Protocol regime has been developed from that of the CWC and had been tailored to address the particular nature of biological agents and toxins.

The declaration follow-up procedures comprising the randomly-selected transparency visits and the carefully tiered provisions for clarification of any ambiguity, uncertainty, anomaly or omission in a declaration made by a State Party are vital for ensuring the consistency of declarations. No State Party would make inaccurate or incomplete declarations if they recognize that the deficiencies in their declaration will be exposed either by the randomly-selected transparency visits or by the declaration clarification procedures. The Protocol provisions enable either the future Organization or individual States Parties to initiate the declaration clarification procedures. Consequently, a State Party to the Protocol contemplating violation of the Convention would have either to carry out its activities in a declared facility -- and risk exposure both through the Organization or through another State Party seeking clarification -- or to use an undeclared facility and again risk exposure both through the Organization or through another State Party seeking clarification of the omission of that facility from the declarations. A useful analogy in considering the necessity of backing up mandatory declarations with follow-up procedures comes from self assessment under the US (and the UK) tax systems – how accurate would self assessment be if there were to be no follow up by the IRS?

In considering the numbers of randomly-selected transparency visits carried out each year under the Protocol – limited to greater than 60 and less than 90 – their duration of no more than 2 days involving no more than 4 members in the visiting team. It has to be recognised that this is a remarkably effective way of enhancing transparency and generating confidence in the consistency of declarations. Remember that the purpose is to demonstrate compliance and to deter would-be violators rather than to find cheaters or catch out States Parties. In building compliance, there is indeed a bonus in that a State Party would be highly unlikely to carry out prohibited activities at declared facilities because of the risk that inconsistencies would be detected. If such prohibited activities were to be carried out at undeclared facilities, then again there would be a risk that inconsistencies would lead to clarification being sought about ambiguities, uncertainties, anomalies or omissions – and such clarification can be sought directly by a State Party and is not dependent on the future Organization. Regular visits to States Parties means that the inspectorate will develop an appreciation of how regulatory frameworks apply in specific States parties, the national standards that apply and improve understanding of national processes. All this will be indispensable knowledge in the event of an investigation. If a facility investigation were ever called in the United States, would it not better if the inspectorate had some prior knowledge or the regulatory frameworks (FDA and EPA for example), norms, practices and degree of sophistication that applied? Such understandings will go a long way in preventing investigation teams misinterpreting what they see and reduce the risk that they might draw the wrong conclusion.

The investigation provisions are for both field and facility investigations of non-compliance concerns. The Protocol includes within field investigations provisions for the investigation of releases of biological agents or toxins.

In sum, the Protocol regime of declarations, follow-up procedures and investigations provides a structured and elaborated framework for the provision of accurate information about the activities and facilities of the most relevance to the Convention. This brings immense benefits as was noted by Dr John Gee, Deputy Director General of the OPCW when he spoke about the success of the declarations made under the CWC when he said that:

What is significant is the fact that declarations have been made and the key parts of each State Party’s declarations are available to all other States Parties….This has been a considerable confidence-building measure….This process has answered a lot of questions that were out there prior to entry into force….all the other countries had to go on were press reports and intelligence estimates and so forth. The whole process of having declarations available to other States Parties has been a great success and a very substantial confidence-building measure.

If the situation with the Protocol in place is compared with the alternative of simply continuing with the Convention, it is impossible to see how the conclusion -- in other testimony to your Committee -- can reached that “a Protocol would not improve our ability to effectively verify compliance with the BWC either in terms of certifying that a country is in compliance with, or in violation of, its obligation”. Without the Protocol all that any country has to go on are press reports, intelligence estimates and so on; intelligence estimates have necessarily to be worst case assumptions and may well give undue credence to rumour and innuendo or simply fail to recognise perfectly legal reasons for an activity. However, with the Protocol in place, there will also be mandatory declarations from States Parties with the means to clarify any ambiguities, uncertainties, anomalies or uncertainties, providing hard evidence as to activities and facilities within the State Party. Any inconsistencies between parts of declarations can be addressed by States Parties as well as by the future Organization leading to a more comprehensive and soundly based appreciation of the activities and facilities within the State Party.

Export Controls

It is widely recognised that the provisions in the Protocol relating to controls of transfers of biological agents or equipment have been one of the most controversial issues. It is, however, essential to examine the issue in perspective and not to get carried away by unsound arguments. First of all, it has to be recognised that the formula adopted in the CWC in the early 1990s in its Article XI that the States Parties shall:

c. Not maintain among themselves any restrictions, including those in any international agreements, incompatible with the obligations undertaken with the Convention, which would restrict or impede trade and the development and promotion of scientific and technological knowledge in the field of chemistry for industrial, agricultural, research, medical, pharmaceutical or other peaceful purpose.

would not be acceptable some 10 years later for the Protocol. To think that time has stopped and the same language would be acceptable would be naïve. However, it is equally naïve to think that the world has moved to a situation in which controls of transfers are no longer required and can be dismantled. The facts are that governments around the world, especially in the developing countries, are increasingly requiring prior notification of the imports of any potentially harmful materials – whether these be banned and severely restricted chemicals under the Rotterdam Prior Informed Consent Convention, genetically modified organisms under the Cartagena Protocol on Biosafety, narcotic drugs and psychotropic chemicals and their precursors under the various UN Drug Conventions or chemical and biological materials relevant to chemical and biological weapons under the CWC and the Biological and Toxin Weapons Convention.

The obligation under Article III of the BTWC is very clear:

Each State Party to this Convention undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in article I of this Convention.

The mandate of the Ad Hoc Group – to strengthen the effectiveness and improve the implementation of the Convention -- is also clear. The language in the Chairman’s composite Protocol text does precisely that – it seeks to improve the implementation of Article III of the Convention – by requiring Each State Party…to review and, if necessary, amend or establish any legislation, regulatory or administrative provisions to regulate the transfer of agents, toxins, equipment and technologies relevant to Article III of the Convention…. There are thus clear benefits – both in countering proliferation and the availability of materials and equipment for bioterrorism – for the international community from this requirement for all States Parties to establish the regulation of such transfers.

The Burden of the Protocol

The mandate for the Ad Hoc Group required that consideration be given to:

A system of measures to promote compliance with the Convention, including, as appropriate, measures identified, examined and evaluated in the VEREX Report. Such measures should apply to all relevant facilities and activities, be reliable, cost effective, non-discriminatory and as non-intrusive as possible, consistent with the effective implementation of the system and should not lead to abuse;