September 29, 1992

ADDRESS BY DR. EDWARD J. LACEY, ACTING ASSISTANT DIRECTOR
BUREAU OF VERIFICATION AND IMPLEMENTATION, UNITED STATES
ARMS CONTROL & DISARMAMENT AGENCY TO THE FALL MEETING OF THE
BIOLOGICAL AND BIOTECHNOLOGY SECTION OF THE PHARMACEUTICAL
MANUFACTURERS ASSOCIATION, BALTIMORE, MARYLAND

It is a pleasure to be here to address the biotechnology section of the Pharmaceutical Manufacturers Association. Your group represents scientific endeavors that are on the cutting edge in developing medicines and other products for improving human welfare. I commend you for the progress you have achieved thus far on behalf of mankind, and I look forward to working together to ensure that United States and international arms control activities will not unduly burden your efforts to maintain America's preeminent position as a world leader in pharmaceuticals.

I am here today to discuss some developments in the international diplomatic arena that have relevance to the American biotechnology industry, which of course includes but is not limited to pharmaceutical production. As you know, the "Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction" (the Biological Weapons Convention, or "BWC") prohibits the development, production, stockpiling and acquisition of "biological agents or toxins of types and in quantities that have no justification for prophylactic, protective and other peaceful purposes," and "weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes." The BWC was opened for signature at Washington, D.C., London, and Moscow in April 1972, and entered into force in 1975. Today, if one includes some of the states that succeeded the former Soviet Union, there are about 120 signatories to the Convention.

The United States unilaterally renounced all methods of biological warfare in 1969, three years before the BWC was signed. The United States ratified the BWC in 1975 when it ratified the 1925 Geneva Protocol which prohibits the use of biological weapons. The United States has maintained only a defensive biological program since 1969. The relevance and importance of this continuing program was underscored during the Gulf War.

Article XII of the BWC provides that if a majority of parties agrees, conferences to review the operation of the Convention may be held every five years. There have been three such review conferences (known as "Revcons") since the Convention entered into force in 1975. These conferences have reviewed the operation of the convention and considered proposals to improve its effectiveness.

The principal outcome of the BWC review conference process has been a series of confidence building measures (known as "CBMs"). These CBMs have consisted primarily of voluntary pledges to provide data on national activities. The purpose of such data declarations is to foster a climate of openness and transparency. For example, one of the confidence building measures proposed by the United States and subsequently adopted by the September 1991 Revcon was a declaration of vaccine production plants under the jurisdiction of States Parties. The United States declaration was simply a summary of publicly available information from the Food and Drug Administration on domestic vaccine production plants -- their names, locations, and the human diseases they address.

The last review conference followed in the wake of the Gulf War, when legitimate concerns were newly raised about the threat of biological weapons use and the development of advanced weapons using genetic engineering techniques. Since the Gulf War, governments the world over have renewed their efforts to deal with these heinous instruments of mass destruction. Many governments, especially in the West, have seized upon the fact that the 1972 BWC has no specific verification provisions; their thinking is that adding verification provisions might help detect or discourage clandestine biological weapons production. Thus, at the last review conference, in addition to approving confidence building measures, many countries wanted to amend the BWC by adding more restrictive, intrusive measures. For reasons I will discuss presently, the United States delegation opposed these measures. However, the United States did agree to formation of a working group of experts whose mission is to evaluate any verification measures proposed by States Parties from a scientific and technical standpoint.

The importance of verification to successful arms control is universally recognized. United Nations Resolution A/RES/43/81 (B) of December 7, 1988 states as its first principle that "Adequate and effective verification is an essential element of all arms limitation and disarmament agreements."

Verification measures are included as part of an arms control agreement to enhance the national capability of parties to monitor compliance and to detect violations in a timely fashion. In addition, verification measures are included to deter violations of an arms control agreement. Of course, judgments about compliance are a national prerogative, and each party must rely on all the information it has available to assess the compliance of the other parties.

The United States draws a clear distinction between confidence building and verification. Confidence building measures provide participants with access to information that encourages a climate of openness and transparency. They also allow participants to demonstrate how their activities should not be considered threatening to others.

Effective verification measures, singly or in combination, should:

Given this understanding of verification, our own analyses indicate that the BWC cannot be made more effective by adding verification measures known to us. The small size and complex structure of microorganisms, and the dual-purpose nature of many items used in biological production, make verification of a ban on biological weapons problemmatic, to say the least. Our concerns about the verifiability of the BWC are the primary reason the United States delegation opposed the proposals for specific verification regimes made at the September 1991 review conference. But it should also be noted that the United States opposes any measure that would limit our ability to pursue a biological defense program or unduly burden American industry.

In sum, let me make our position clear: The United States believes that the community of nations cannot and must not tolerate the development, production, and stockpiling of biological and toxin weapons. The United States strongly supports the 1972 Biological Weapons Convention as a significant international norm. We attach great importance to its prohibitions and to making those prohibitions as universal and effective as possible. However, the United States opposes the adoption of ineffective verification provisions that could create a false sense of security with respect to compliance with the BWC and that could adversely affect legitimate defensive and commercial activities in this area.

THE AD HOC GROUP OF EXPERTS (OR STUDY GROUP)

Despite the inherent problems we believe are associated with establishing a verification regime for the BWC, the United States agreed to participate with an open mind in the international experts study designed to examine potential verification measures from a scientific and technical standpoint.

According to the final declaration of the September 1991 review conference, the charge of the study group (also known as the Ad Hoc Group of Experts) is to seek to identify measures which would determine:

The mandate also asks the Ad Hoc Group of Experts to examine potential verification measures in terms of the following main criteria:

All of the criteria -- including the last, which deals with the potential impact of possible verification measures on legitimate commercial endeavors -- were required for United States acceptance of the final declaration. The last criterion represents an area of study in which the United States Government most needs industry support.

At this point, I would like to describe the work of the study group to date. The first meeting of the Ad Hoc Group took place from March 30 to April 10 of this year. The most important result of the meeting was agreement on a list of potential measures for evaluation against the mandate criteria. Participating States Parties also agreed to evaluate the measures in the context of the three general types of activity prohibited by the Convention. These are development; production and acquisition; and stockpiling of biological weapons. The potential measures themselves include information monitoring, remote sensing, inspections, and continuous monitoring proposals.

The United States envisions about three more meetings: one to analyze the technologies that would be associated with proposed measures on the list, one to evaluate proposed measures according to the agreed criteria, and one to compile a final report for States Parties. The final report will be an analysis, not a draft verification regime. The participants in the study group consist of a mixture of experts in the fields of arms control, verification, microbiology, biological defense, and biotechnology. Any decision-making would take place at the policy level after States Parties receive the final report of the experts. The final report is expected at the end of 1993.

The next meeting will be held from November 23 to December 4. The United States will be prepared at this meeting to discuss the capabilities and limitations of technologies that might be employed in carrying out the proposed measures.

MEASURES PROPOSED FOR STUDY

Let me review some of the measures proposed for study and how they have the potential to affect industry if adopted.

The measures identified by the study group at the first meeting in April were subdivided into two categories: "off-site" and "on-site" measures. "Off-site" measures include remote sensing and various types of information monitoring. "On-site" measures comprise inspections, exchange visits and continuous monitoring.

In brief, the information monitoring and data exchange proposals are envisioned as mechanisms by which States Parties could individually or collectively gather information that is available from open sources such as technical journals, compilations of national legislation, and reports on national regulatory activities. Data exchange measures could involve either individual or collective gathering of reports on various national activities of interest.

Remote sensing encompasses surveillance by satellite or aircraft, or the stationing of sensors on the ground at a distance from areas of interest. Products of remote sensing could be visual imagery such as photographs, or "printouts" of the chemical composition of the air or water at a given point. Remote sensing, of course, would not involve penetration by inspectors or equipment into any facility.

Perhaps of greater interest to this audience are the "on site" measures proposed for study. On-site inspections could entail interviewing staff at a particular facility, visually examining equipment, and taking samples from the facility. If a proposed verification regime contained provisions to confirm the presence of certain equipment such as fermenters or centrifuges, this equipment would be identified by inspectors. Safety, quality control, and manufacturing records might be reviewed. If a sampling regime were agreed, samples might be taken from a facility's process or waste streams, or the surfaces of work areas. A more intrusive regime also could feature the taking of blood and tissue samples from personnel at the facility.

Continuous monitoring on site could involve the stationing of various instruments that conduct automated sampling, or that gauge a variety of process parameters (such as concentrations of dissolved oxygen), or that simply take video recordings of ongoing operations. Continuous monitoring also could take place in the form of human inspectors that operate in round-the-clock shifts to monitor facility activities. Clearly, an international regime incorporating any of the elements I have just described would have an impact on industry.

Differing views have been expressed as to what would be accomplished by inspections and other measures. Debate also has occurred with respect to categorizing such variables as the intrusiveness of possible inspections, and the ease of establishing continuous monitoring systems. In addition, some discussion has taken place as to the type and number of facilities which could be affected by any possible regime.

At this point, the experts are in the study phase. The report of the technical experts, due at the end of 1993, will be forwarded to the governments of States Parties. It is our view that the best way to prepare for any future decisions is to provide an experts report that reflects the technical and scientific realities that challenge any efforts to elaborate a viable and effective verification regime for the BWC. It is also our view that any proposed regime must not have an unacceptable impact on United States industry.

The United States Government has not made any verification proposals, nor does it expect to make any. However, we are willing to examine for their technical merits any ideas advanced by others. In this effort, we would be grateful for any industry views on the measures I have described.

CONCLUSION

There are approximately 1,100 companies in the United States engaged in some aspect of biotechnology. About 70,000 people are employed by these companies. In light of the fact that there is a growing BW proliferation problem, the United States has supported confidence building measures; however, we feel strongly that such CBMs should not pose an undue burden on these workers or harm the competitiveness of American companies. At the same time, our recent experience in the Gulf War has added a sense of urgency to efforts to combat the proliferation of biological and other weapons of mass destruction. It is obvious that a number of States Parties are determined to add "verification measures" to the BWC regardless of their potential costs or effectiveness. Our goal will be to focus the discussion on the mandate criteria and to adhere to a technical and scientific evaluation of any proposals that may be advocated.

At the next meeting, the United States delegation will insist that political decisions about particular verification measures or complete verification regimes should not be made until after the experts study is complete and circulated to States Parties. Only after all participating countries have an understanding of the technical merits of various proposals will they be able to make appropriate decisions about them in the future. It is my hope that as the United States prepares for the next meeting in Geneva, we can rely on industry to provide us with insights and information that would help us to understand the impact of any proposed measures on our industry here at home.