[House Hearing, 107 Congress] [From the U.S. Government Publishing Office] BIOLOGICAL WEAPONS CONVENTION PROTOCOL: STATUS AND IMPLICATIONS ======================================================================= HEARING before the SUBCOMMITTEE ON NATIONAL SECURITY, VETERANS AFFAIRS AND INTERNATIONAL RELATIONS of the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SEVENTH CONGRESS FIRST SESSION __________ JUNE 5, 2001 __________ Serial No. 107-71 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform U. S. GOVERNMENT PRINTING OFFICE 80-137 WASHINGTON : 2002 ___________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania STEPHEN HORN, California PATSY T. MINK, Hawaii JOHN L. MICA, Florida CAROLYN B. MALONEY, New York THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington, MARK E. SOUDER, Indiana DC JOE SCARBOROUGH, Florida ELIJAH E. CUMMINGS, Maryland STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois DAN MILLER, Florida DANNY K. DAVIS, Illinois DOUG OSE, California JOHN F. TIERNEY, Massachusetts RON LEWIS, Kentucky JIM TURNER, Texas JO ANN DAVIS, Virginia THOMAS H. ALLEN, Maine TODD RUSSELL PLATTS, Pennsylvania JANICE D. SCHAKOWSKY, Illinois DAVE WELDON, Florida WM. LACY CLAY, Missouri CHRIS CANNON, Utah ------ ------ ADAM H. PUTNAM, Florida ------ ------ C.L. ``BUTCH'' OTTER, Idaho ------ EDWARD L. SCHROCK, Virginia BERNARD SANDERS, Vermont ------ ------ (Independent) Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director James C. Wilson, Chief Counsel Robert A. Briggs, Chief Clerk Phil Schiliro, Minority Staff Director Subcommittee on National Security, Veterans Affairs and International Relations CHRISTOPHER SHAYS, Connecticut, Chairman ADAM H. PUTNAM, Florida DENNIS J. KUCINICH, Ohio BENJAMIN A. GILMAN, New York BERNARD SANDERS, Vermont ILEANA ROS-LEHTINEN, Florida THOMAS H. ALLEN, Maine JOHN M. McHUGH, New York TOM LANTOS, California STEVEN C. LaTOURETTE, Ohio JOHN F. TIERNEY, Massachusetts RON LEWIS, Kentucky JANICE D. SCHAKOWSKY, Illinois TODD RUSSELL PLATTS, Pennsylvania WM. LACY CLAY, Missouri DAVE WELDON, Florida ------ ------ C.L. ``BUTCH'' OTTER, Idaho ------ ------ EDWARD L. SCHROCK, Virginia Ex Officio DAN BURTON, Indiana HENRY A. WAXMAN, California Lawrence J. Halloran, Staff Director and Counsel R. Nicholas Palarino, Senior Policy Advisor Jason M. Chung, Clerk David Rapallo, Minority Counsel C O N T E N T S ---------- Page Hearing held on June 5, 2001..................................... 1 Statement of: Zelicoff, Alan, senior scientist, nonproliferation initiatives, Sandia National Laboratories; Amy Smithson, senior associate, Henry L. Stimson Center; Barbara Hatch Rosenberg, project director, Chemical/Biological Arms Control, Federation of American Scientists; Gillian R. Woollett, associate vice president, biological and biotechnology, Pharmaceutical Research and Manufacturers of America; and Colonel Robert P. Kadlec, professor of military strategy and operations, National War College..... 6 Letters, statements, etc., submitted for the record by: Kadlec, Colonel Robert P., professor of military strategy and operations, National War College, prepared statement of.... 57 Rosenberg, Barbara Hatch, project director, Chemical/ Biological Arms Control, Federation of American Scientists, prepared statement of...................................... 29 Shays, Hon. Christopher, a Representative in Congress from the State of Connecticut: Letter dated June 1, 2001................................ 90 Prepared statement of.................................... 3 Smithson, Amy, senior associate, Henry L. Stimson Center, prepared statement of...................................... 18 Tierney, Hon. John F., a Representative in Congress from the State of Massachusetts, prepared statements of Ambassador Sheaks and Ambassador Mahley............................... 73 Woollett, Gillian R., associate vice president, biological and biotechnology, Pharmaceutical Research and Manufacturers of America, prepared statement of............ 45 Zelicoff, Alan, senior scientist, nonproliferation initiatives, Sandia National Laboratories, prepared statement of............................................... 10 BIOLOGICAL WEAPONS CONVENTION PROTOCOL: STATUS AND IMPLICATIONS ---------- TUESDAY, JUNE 5, 2001 House of Representatives, Subcommittee on National Security, Veterans Affairs and International Relations, Committee on Government Reform, Washington, DC. The subcommittee met, pursuant to notice, at 2:05 p.m., in room 2154, Rayburn House Office Building, Hon. Christopher Shays (chairman of the subcommittee) presiding. Present: Representatives Shays, Putnam, Gilman, Shrock, and Tierney. Staff present: Larry Halloran, staff director and counsel; R. Nicholas Palarino, senior policy advisor; Jason M. Chung, clerk; Kristin Taylor, intern; and David Rapallo, minority counsel. Mr. Shays. A quorum being present, the Subcommittee on National Security, Veterans Affairs and International Relations hearing, entitled, ``Biological Convention Weapons Protocol: Status and Implications,'' is called to order. In 1969, the United States unilaterally renounced the use of biological weapons and foreswore all aspects of an offensive bioweapons program. The Soviet Union also claimed no active interest in germ warfare. Based in part on those mutual assurances, rare in the bipolar cold war strategy environment, drafters of the 1972 Biological Weapons Convention [BWC], did not attempt to include verification or enforcement provisions. But the disclosure of a vast biological arsenal, of a vast Soviet biological arsenal, Iraq's use of prohibited toxic agents against Iran, and the emergence of terrorists eager to inflict mass casualties generated calls to strengthen the BWC. For almost a decade, discussions have been underway among the 159 BWC signatory nations on ways to verify compliance and deter violations. Consensus on a workable addendum or protocol to the BWC has proven elusive. Negotiators have been frustrated by the inherent difficulty, some would say utter impossibility, of policing the proliferation of nationally occurring organisms and dual-use technologies so easily converted from lawful to lethal purposes. Many doubt arms control principles and regimes--regimens designed to stop missiles will work against microbes. Some believe the proposed protocol will provide little benefit in the fight against biological weapons, while placing an unjustifiable burden solely on those already committed to wage that fight. Working toward a target, not a deadline, of next November to present a complete protocol to the BWC Review Conference, the ad hoc group of negotiators in Geneva recently began considering proposals to resolve critical and controversial issues: expert controls, facility declaration thresholds, inspection triggers, the extent of onsite activities, and role of enhanced disease surveillance in detecting violations. As the negotiating intensifies, pressure will build to adopt a protocol, almost any protocol, if only as a symbol of that political will to do something about biological weapons. But against so insidious a threat, against a class of warfare, the BWC itself declares, ``repugnant to the conscience of mankind,'' a symbolic step is no substitute for substantive progress. Settling for symbolism could in fact undermine the political consensus and technical support needed to achieve tangible results. The previous administration said as much last September in testimony before this subcommittee. Ambassador Donald Mahley, special negotiator for chemical and biological arms control, told us, ``the United States will not accept a protocol that undermines rather than strengthens national and international efforts to address the BW threat.'' Continuing our oversight of the U.S. approach to this critical issue, we invited the new administration and the panel of distinguished experts to assess the status and implications to the BWC protocol. We ask them to address how the U.S. negotiating position was formulated, how national security data and private property can be protected in any intrusive declaration and inspection regimen, and what additional steps might be proposed to improve BWC implementation. Yesterday the White House requested more time to finalize a response to our questions. I regretfully in some ways acceded to that request but felt that I would do that. But we will hear testimony from witnesses who bring a breadth of experience and depth of insight to this discussion. We appreciate their time and their expertise, and we look forward to their testimony. And I will say that when the administration made the request to defer testifying before this committee, we were going to cancel, and then we realized, certainly we acknowledged the fact that we have an excellent panel. We know that some of you came here to testify, and we thought that it is important that we proceed. So we are happy you are here. We are delighted to have this hearing, very unhappy the administration has once again requested a deferment before this committee. [The prepared statement of Hon. Christopher Shays follows:] [GRAPHIC] [TIFF OMITTED] T0137.001 [GRAPHIC] [TIFF OMITTED] T0137.002 Mr. Shays. At this time I'd invite Mr. Putnam, if he has any statement to make, the vice chairman of the committee. Mr. Putnam. Thank you, Mr. Chairman. I appreciate your putting together this hearing and I appreciate the panel that you have assembled coming here today, and eagerly await the White House's response to your request. Mr. Shays. Thank you. Mr. Schrock. Mr. Schrock. Mr. Chairman, I have no formal statement, but I welcome you as well. Mr. Shays. Great. Well, we are about to proceed, and let me just get rid of some technical requirements here. I ask unanimous consent that all members of the subcommittee be permitted to place an opening statement in the record and that the record remain open for 3 days for that purpose. Without objection, so ordered. I ask further unanimous consent that all witnesses be permitted to include their written statement in the record, and, without objection, so ordered. We have a panel of five people, and we have been looking forward to hearing from this panel. We have Mr. Alan Zelicoff, senior scientist, Nonproliferations Initiative, Sandia National Laboratories. Did I say that right? Mr. Zelicoff. You did, sir. Mr. Shays. And we have Dr. Amy Smithson, senior associate, Henry L. Stimson Center. Where is that? Ms. Smithson. It is here in Washington, DC, sir, at Dupont Circle. Mr. Shays. And Dr. Barbara Hatch Rosenberg, a project director, Chemical/Biological Arms Control, Federation of American Scientists. And we have Dr. Gillian R. Woollett? Ms. Woollett. It's Gillian Woollett. Mr. Shays. Gillian Woollett, thank you--with a nice accent. Associate vice president, biological and biotechnology, Pharmaceutical Research and Manufacturers of America. And Colonel Robert P. Kadlec, professor of military strategy and operations, National War College. This is our only panel. We have 5 minutes. We are going to roll over. So you have 10 minutes if you need it. Somewhere between 5 and 10 we would like you to finish, and we are ready to go, except we have to swear you in. You can still see I am unhappy we have one panel instead of two. If you would stand up and raise your right hands, please. [Witnesses sworn.] Mr. Shays. Note for the record everyone has responded in the affirmative. We need a little oil for this thing here. You are on. STATEMENTS OF ALAN ZELICOFF, SENIOR SCIENTIST, NONPROLIFERATION INITIATIVES, SANDIA NATIONAL LABORATORIES; AMY SMITHSON, SENIOR ASSOCIATE, HENRY L. STIMSON CENTER; BARBARA HATCH ROSENBERG, PROJECT DIRECTOR, CHEMICAL/BIOLOGICAL ARMS CONTROL, FEDERATION OF AMERICAN SCIENTISTS; GILLIAN R. WOOLLETT, ASSOCIATE VICE PRESIDENT, BIOLOGICAL AND BIOTECHNOLOGY, PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA; AND COLONEL ROBERT P. KADLEC, PROFESSOR OF MILITARY STRATEGY AND OPERATIONS, NATIONAL WAR COLLEGE Mr. Zelicoff. Thank you, Mr. Chairman. Mr. Shays. Thank you. Mr. Zelicoff. I am honored for this opportunity to address you today, and since your time is precious, I'll briefly fill you in on my background and then get right to the items that you have asked me to address. My name is Alan Zelicoff. I am a physician and physicist, and I work in the Center for National Security and Arms Control at Sandia National Laboratories, which is one of the three Department of Energy weapons labs, but we're charged with a broad array of tasks addressing national security outside the nuclear realm. My center, in which I am one of two senior scientists, has had considerable experience in the primary research and development in a wide array of verification technologies for use in most of the existing multilateral and bilateral arms control treaties to which the United States is a signatory. We're also deeply involved in the day-to-day analysis of data of relevance to these treaties, and provide technical support to both the international and national bodies responsible for implementation and monitoring of these treaties. In particular, Sandia designed and carried out the most extensive of all mock trial inspections for the Biological Weapons Convention, both in the United States and internationally, following its participation in very similar studies that predated the final negotiations and signatures on the Chemical Weapons Convention. Now, the committee has heard before from Mr. Mahley and others of the very--of the many problematic differences between verification of the Chemical Weapons Convention and putative verification of the Biological Weapons Convention. I'm not going to repeat those very important distinctions as I respond to the committee's charge, but in so doing, I will try to provide you with a technical as opposed to political reference point and I will refer to some of those distinctions that have been made previously. And, again, I will try to be technical, as I'm quite sure you get more than enough politicized information up here on the Hill, and as a scientist I'll try to endeavor to highlight some objective data and observations that I hope will assist you in your work. First, the committee asked how the United States developed verification policy for the Biological Weapons Convention. Well, we began well enough and I believe in a highly credible way with a series of surveys of experts to identify the potential unique and problematic aspects of inspections in support of the BWC, followed then by increasingly sophisticated mock inspection exercises based on questions raised during those surveys. These exercises were conducted in a variety of facilities, including the manufacturing facility at Department of Defense biological weapons defense laboratory, a university medical school and the most advanced aerosol-biology facility in the United States, and finally at an explosives testing facility, all of which are of potential relevance to the BWC. And this constitutes the entirety of the United States' experience in testing measures such as challenge inspections, compliance assurance, and familiarization visits; in other words, more or less the compendium of all of the approaches that have been advocated for strengthening the BWC. In my technical opinion, these trial inspections constitute as well the entirety of scientifically designed, well-controlled investigations into the utility of various measures done anywhere by anyone. And here I would like to issue an important caution to the members of the committee. When you hear claims that other trial inspections for the BWC resulted in successful demonstration of such items as managed access, compliance checking, protection of proprietary information, or validation of declarations under the treaty, be just a bit skeptical. To the best of my knowledge, none--and I mean none--of the other mock inspections that have been conducted meet any of those scientific requirements for trial inspections; and none save those--none in the United States, have been published with their methodologies, hypotheses and analyses for all to see. Trial inspections are very difficult. They are expensive to execute properly, and it is all too easy to conduct a trial and populate it with hand-picked participants to get the answers that one wishes to hear. We can do, and we did do much better than this. The U.S. trial outcomes, Mr. Chairman, were clear. Only two measures that have been proposed for the BWC, challenge inspections and disease outbreak surveillance and investigation, resulted in information that was useful for monitoring the BWC. The other oft-touted measures, such as declarations checking, resulted in so much ambiguous data that the inspection teams left the sites, convinced that legitimate activities were covers for biological weapons activities. There is no mystery in this. Most of the activities in the daily work of pharmaceutical and biodefense facilities are indistinguishable from activities that could be prohibited by the BWC. Conversely, illicit work might be done in similar places and is very easily hidden. And our technology, regrettably, at the moment does not provide us with the diagnostic tests that can separate evil intent from legal and perfectly permissible activities. To be concrete, a random visit to a modern pharmaceutical facility, for example, would be unlikely to uncover prohibited activities, even if they existed, because of the size and multiplicity of processes taking place. Rather, the very acts of genetic engineering, large-scale fermentation, and the entire array of standard operating procedures will meet any expectations in the pre-formed eye of the beholder. On the other hand, if a specific allegation were to be leveled, for example, production of large quantities of anthrax at a specific time and place, there is a reasonable chance that the illegal activity would be unveiled, assuming that access was granted in a timely fashion. Despite these valuable results, the process of policy development within the U.S. Government, protocol negotiations soon faltered. It is, Mr. Chairman, a not very well-kept secret that there was intense friction between the National Security Council and the entirety of the Interagency Working Group on Biological Weapons Control throughout the past 8 years while policy was under development. Essentially, nothing in the way of tangible policy was put forward during this time because one, or at most a few, low-level staffers within the NSC sought to suppress the results of the mock inspections, break interagency consensus on negotiating strategy, and impose an extraordinarily ill-suited vision for the BWC protocol, which was to make it like the chemical weapons protocol. Nothing could be more wrong-headed, for all of the reasons you heard in last September's testimony, and nothing could be more destructive for the future of the BWC. There is no question that there was a complete absence of serious administration attention to the negotiations taking place in Geneva. Otherwise these grating questions about goals and tactics that haunted all members of the delegation for the past 8 years would have been resolved. That low-level NSC functionaries were able to force gridlock speaks volumes about the lack of leadership for and periodic review of the U.S. negotiating stance. Now, this brings me to the second question raised by the committee, which is what was the ability--what is the ability of the chairman's text to detect and deter rogue nations' BW activity? The answer is very little, and the reasons are very simple. The vast majority of effort in the chairman's text is directed at routine random visits--primarily in the West, the plurality in the United States--for purposes of checking on declarations of items and stocks which are in and of themselves very fluid. And it was these very types of visits that were simulated in the U.S. trials and that were the source of so much confusion and actual undermining of confidence in compliance during those trials. Once again, the NSC broke consensus on even the utility of disease monitoring, which was also demonstrated to be an effective measure, which was a most unusual state of affairs, because there was interagency consensus on the utility of disease monitoring and, sadly, abrogation of the usual understanding of the way interagency politics works cost the U.S. delegation any chance of unifying to significantly influence the outcome of debates in Geneva, including in the western group. Let me be clear. We were forbidden--and I mean forbidden-- to present the results of U.S. trial inspections, even after other countries introduced data from scientifically very flawed trials, and a leadership vacuum resulted. Mr. Chairman, I do not suggest that the U.S. trial inspection work constitutes a significantly large experience to draw final conclusions about measures that may, with further work, be crafted in a way to strengthen the BWC, but the design of these experiments done in the United States is far superior to those done in other countries that reported them in Geneva. Rather, Mr. Chairman, when combined with the reports of the U.N. Special Commission on inspections of Iraqi BW sites, the analysis of all of this information leads me to question the standard tenets of arms control in the context of biological weapons. Frequent visits to check declarations are not necessarily better than challenge inspections alone. Declaring collections of microorganisms, whose functionality can easily be changed from a predetermined list, is arguably worse than no information at all. Doing something should never be confused with doing something useful. Verification advocates, especially those in the scientific community such as the Federation of American Scientists, have a responsibility to carefully test these assertions. It is noteworthy that the Congress had sufficient insight to mandate several years ago more trial inspections, yet the administration just past ignored this requirement, almost certainly because BWC verification proponents within the NSC did not want to learn any lessons from those inspections. But the end result need not be tragic. There are at least two areas where I do believe substantive support to the treaty can be garnered, as well as meet the interests of all States Parties, and that would be technical cooperation in the identification and mitigation of infectious diseases and swift punishment for countries that employ biological weapons resulting in those diseases or support terrorist groups who acquire them. On rare but important occasions, a network, which I believe would cost only in the range of about $100 million over an entire decade, of disease reporting stations could identify the emergence of unusual symptoms and signs that would raise questions of violation of the biological weapons treaty. There is little doubt that the techniques of modern epidemiology could identify the source of the disease and distinguish between naturally occurring diseases and intentionally introduced diseases. To conclude, Mr. Chairman, negotiations on a protocol for the BWC have failed to produce a document that strengthens the convention or increases the security of its member States Parties. We must await new technologies in order to verify nonproliferation of biological weapons. Only a political sea change will permit the elimination of some of the controls that currently exist, such as export controls, and I would never advocate that. The current turmoil in Russia makes it unlikely that the largest biological weapons program in the world cannot come under control, protocol or not. But nations of goodwill can immediately address the pervasive problems of infectious disease, which is of concern to all of us, and the BWC provides the best possible forum for meeting that need. Thank you for your patience, Mr. Chairman. Mr. Shays. Thank you for your very provocative statement. [The prepared statement of Mr. Zelicoff follows:] [GRAPHIC] [TIFF OMITTED] T0137.003 [GRAPHIC] [TIFF OMITTED] T0137.004 [GRAPHIC] [TIFF OMITTED] T0137.005 [GRAPHIC] [TIFF OMITTED] T0137.006 [GRAPHIC] [TIFF OMITTED] T0137.007 [GRAPHIC] [TIFF OMITTED] T0137.008 Mr. Shays. Ms. Smithson. Ms. Smithson. Given Al's summary of the missteps that have occurred over the past several years--am I not on? Mr. Shays. Yes, you are on. I need you to put the mic in front of you and down a little lower, and you'll be great. Ms. Smithson. Given Al's summary of the missteps over the past few years, what I'd like to do is concentrate for the next few moments on constructive steps forward for the United States. My statement is based largely on the views of over 30 nongovernmental experts as presented in a recent Stimson Center report, ``House of Cards.'' Concerned about the wayward direction of the BWC negotiations and the U.S. Government's rather lackadaisical approach to these talks, the Stimson Center recruited stellar experts from the three types of facilities likely to be monitored by the BWC; namely, research institutes and universities, pharmaceutical and biotechnology companies and defense contracting firms. We asked these experts to brainstorm the vexing technical challenges of BWC monitoring and assembled a fourth group, nicknamed ``Inspection Veterans,'' to cull the technical lessons they that learned from several BWC inspection-like activities, such as the two U.S. BWC trials and the 1992 trilateral agreement inspections, which were aimed at confirming the closure of former Soviet biowarfare facilities. The academic and industry group experts separately devised their own monitoring strategies that they believed would work reliably and effectively in their respective settings. However, they differed on several important inspection parameters with what is known as the chairman's text. For example, the chairman's text stipulates a four-member team for nonchallenge visits, but academic experts asked for five to seven inspectors; and industry experts, for an even larger team of six to eight. Whereas the chairman's text would authorize just 2 days for nonchallenge visits, the academic group believed that 3 days would probably be needed for large laboratories, and the industry group thought that 5 days would be required at commercial sites. When addressing the BWC protocol, negotiators in Geneva on May 7th, during the event releasing House of Cards, one of our industry brainstormers, Dr. Steve Projan, who is the Director of Antibacterial Research at Wyeth-Ayerst Research, summed up the inadequacy of the draft protocol's nonchallenge inspection provisions by saying, ``four inspectors for 2 days couldn't even get around all the bathrooms at my facility.'' Quite frankly, the industry and academic experts were not very impressed with the draft BWC protocol. The chairman's text appears to have bent over backward to minimize the inconvenience and intrusiveness of inspections. While it is important to hold down the burden of inspections, skimping on manpower and time onsite could yield poor results. These experts repeatedly pointed out that while BWC inspectors must be able to detect noncompliance, they must also know compliance when they see it at legitimate facilities. BWC inspections, they said, should not erroneously tar all university laboratories, research institutes, and industry facilities with suspicion that they are somehow operating outside of the law when inspectors are not present. This can't leave question marks hanging over everyone's head. Asked to give the draft BWC protocol a grade, another one of our industry experts explained why the industry groups settled on a grade of D. That is really about the worst grade you can get, said Dr. George Pierce, formerly the manager of technology development and engineering for Cytec Industries. He continued to explain that sometimes an F shows a little innovation. Aside from a BWC protocol that can reliably produce meaningful monitoring results, other programs necessary to grapple with a problem as complex as biological weapons proliferation include, as Dr. Zelicoff has recommended, enhanced global disease surveillance as well as the maintenance of robust intelligence capabilities and defenses, and wisely designed and well-implemented export controls. I would add to that list cooperative threat reduction program activities to reduce the leakage of weapons know-how and ingredients from the former Soviet Union, over 50 biowarfare facilities involved. These so-called brain-drain prevention programs are particularly important if former--because if former Soviet bioweaponeers were to succumb to job offers from terrorists or from governments, they could accelerate rudimentary weapons programs into ones capable of mass casualty attacks. An ounce of prevention, via a hefty budget increase for collaborative research grants, could help cut this proliferation problem off at its source. As for the BWC protocol, the nongovernmental experts that participated in the Stimson Center's brainstorming series would advise the U.S. Government to reject the chairman's text. Any deal is not better than no deal in this case. But they would certainly not advise the U.S. Government to abandon the negotiating process. All four groups of experts recommended additional technical research and field trials to identify and refine the best monitoring procedures for the BWC. For its part, the Pharmaceutical Research and Manufacturers of America long ago offered its expert technical assistance to help with the BWC protocol. But years later, this statement rings empty, since no industry field trials have been held. Therefore, it is incumbent upon the U.S. industry and the U.S. Government to mount good-faith efforts to test BWC monitoring technologies and strategies fully, inviting international observers into this process to inspire confidence that the United States will not desert the negotiations. Congress should redirect both the executive branch and U.S. industry to waste no time in initiating an earnest search for meaningful, feasible and cost-effective monitoring approaches to the BWC. Thank you for the invitation, your time, and I look forward to your questions. Mr. Shays. Thank you, Ms. Smithson. [The prepared statement of Ms. Smithson follows:] [GRAPHIC] [TIFF OMITTED] T0137.009 [GRAPHIC] [TIFF OMITTED] T0137.010 [GRAPHIC] [TIFF OMITTED] T0137.011 [GRAPHIC] [TIFF OMITTED] T0137.012 [GRAPHIC] [TIFF OMITTED] T0137.013 [GRAPHIC] [TIFF OMITTED] T0137.014 [GRAPHIC] [TIFF OMITTED] T0137.015 [GRAPHIC] [TIFF OMITTED] T0137.016 Mr. Shays. Dr. Rosenberg. Ms. Rosenberg. I want to thank you for the opportunity to speak here for the many experts outside of government who support the rapid completion of a protocol to strengthen the Biological Weapons Convention. I chair the Federation of American Scientists Working Group on Biological Weapons, a group of professionals who have broad expertise, who volunteer their 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 bioscience and technology. My working group has monitored the course of the Biological Weapons Convention and contributed to every effort to strengthen it for more than 12 years. We have conducted trial inspections and held in-depth discussions with inspectors and inspection agencies. We've contributed nearly 50 reports and working papers on technical issues to the protocol negotiations and have organized many seminars for negotiators in Geneva. We've always worked closely with industry and have issued two joint papers with representatives of the Pharmaceutical Research and Manufacturers of America. I want to start by making sure that a central point is absolutely clear. We are not here to debate whether the chairman's text for the protocol can be relied upon to detect violations of the Biological Weapons Convention. In a situation like this one, where there are similarities between legitimate and illegitimate activities, no protocol or any other mechanism can do that. Finding smoking guns is not what the protocol is about and not what negotiators have ever aimed for. The United States and all the other parties knew this before the negotiations started--it started. They knew it when they studied the feasibility of verifying the convention and issued a positive report. It would be disingenuous to beat that dead horse now. Rather, the objective of the protocol is confidence building and transparency. Let me explain for a moment what transparency means in this context. Novices tend to suppose that it would require divulging exactly what is going on at an installation. That is nonsense. Experienced technical experts can judge from the scale, the layout, the type of equipment present, the ability to prevent the escape of dangerous agents and such factors, that can judge from these whether these capabilities match the alleged peaceful purpose of an installation and its role, if any, in civil society. Rapid cleanup of an installation before the arrival of inspectors is almost irrelevant. It might even provide a clue in itself. Factors like these were the ones that allowed UNSCOM inspectors in Iraq to recognize questionable situations almost at first glance. Getting publicizable proof was the difficult part, but I emphasize again, that is not the role of the protocol. 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 regime would effectively complement national intelligence, military power and diplomacy. In a serious situation, the protocol would provide bases broader than we now have for international action. To achieve adequate transparency, the chairman's text of the protocol requires annual declaration of the sites of greatest potential threat, plus a variety of onsite measures: first, mandatory, randomly selected visits to declared facilities; second, visits to clarify any remaining questions if clarification consultations should fail; and third, mandatory challenge investigations anywhere. It's ironic that while we suspect Iraq of continuing its biological weapons program and we decry its refusal to allow U.N. inspections, the United States is poised to turn down an international agreement that would provide three different means for probing suspicious installations. Even a refusal to allow access in violation of the protocol would provide information. A former Deputy Director of the CIA, Doug MacEachin, has made a persuasive case for the deterrent effect of the protocol regime. In a recent article, he explains why the regime would prevent proliferators from using ostensibly legitimate facilities for illicit programs. To avoid raising suspicions, they would have to conduct bioweapons activities clandestinely, with all the attendant difficulties and risks. International steps to strengthen the Biological Weapons Convention began in 1986 during the Reagan administration. They continued with the positive feasibility study I mentioned during the first Bush administration and then proceeded into the protocol negotiations 6 years ago. Throughout, there was vocal bipartisan support from the United States. We've led the chorus in citing the need for action. Now with the goal almost within our grasp, rejection of the protocol will send a message to potential proliferators that will tell them that there is no international will to enforce the ban on biological weapons. Americans will pay the price as the prime target. Military and nongovernment experts agree that bioterrorists are highly unlikely to be able to launch a mass attack without state support. It would be foolhardy not to do all we can to cutoff the source by monitoring the compliance of states with the biological weapons ban. But this is not something the United States can do unilaterally. The protocol is the available tool, and that's why our European and other allies are so angered and dismayed by the U.S. stance. Had the United States stood with its allies and presented a united front at the negotiations, the chairman's protocol text would be stronger now. Had the United States not demanded many weakening concessions, the text would be better. But one thing is clear. The protocol does not suffer from any lack of technical information. The problems are political, not technical. Although the United States submitted no reports on trial onsite activities, 12 trials have been reported by other countries, most of them U.S. allies. And some of the trials took place at facilities belonging to the very same corporations that are major players in the United States. I have a table which may be projected here, but I believe the Members have copies, and you can't read it anyway, but you have copies. It's a 3-page table which shows the trial visits that have been carried out. I will just point out that many of the trials involved more than one country or included foreign observers, and no U.S. trial will have any credibility that doesn't do the same. All the trials that have been carried out concluded that the visits would be effective in strengthening the convention and increasing confidence in compliance, and that confidential information could be protected at the same time. In addition to the trials, there are copious data from the many different national and international inspections that are carried out routinely at sites relevant to the protocol, both here and in many other countries. The chairman's text meets all the essential demands of U.S. industry. It provides more safeguards for confidential information than the Chemical Weapons Convention, which covers many of the same facilities and to which we are already a party. As for export controls, the rhetoric of the text may please the critics of the Australian Group. The Australian Group is a cooperative mechanism for controlling dual-use chemical and biological exports. But the substance of the chairman's text is fully in line with the western position. There are only guidelines, no hard obligations regarding exports. Each state party has full discretion over every measure suggested in the text. In closing, I'd like to point to several additional actions that need to be taken to supplement the protocol in controlling biological weapons. These are described in my written testimony, and there's no time here now. One of these actions is a program for effective global surveillance of emerging diseases. This program, proposed by an alliance of the World Health Organization and several other health groups, known as AllAID, Would fulfill the obligations of parties to the convention to ``cooperate for the prevention of disease,'' to use the words of the convention. To do this, the proposed program addresses the specific goals already agreed by the protocol negotiators, but there is little hope of funding this necessarily multilateral program without the incentives that the protocol would provide. And I hope in the question period we will have a greater opportunity to discuss this program. Thank you very much. Mr. Shays. Thank you very much, Dr. Rosenberg. [The prepared statement of Ms. Rosenberg follows:] [GRAPHIC] [TIFF OMITTED] T0137.017 [GRAPHIC] [TIFF OMITTED] T0137.018 [GRAPHIC] [TIFF OMITTED] T0137.019 [GRAPHIC] [TIFF OMITTED] T0137.020 [GRAPHIC] [TIFF OMITTED] T0137.021 [GRAPHIC] [TIFF OMITTED] T0137.022 [GRAPHIC] [TIFF OMITTED] T0137.023 [GRAPHIC] [TIFF OMITTED] T0137.024 [GRAPHIC] [TIFF OMITTED] T0137.025 [GRAPHIC] [TIFF OMITTED] T0137.026 [GRAPHIC] [TIFF OMITTED] T0137.055 [GRAPHIC] [TIFF OMITTED] T0137.056 [GRAPHIC] [TIFF OMITTED] T0137.057 [GRAPHIC] [TIFF OMITTED] T0137.058 Mr. Shays. Dr. Woollett. Ms. Woollett. Good afternoon. My name is Dr. Gillian Woollett. I'm the associate vice president for biologics and biotechnology at PhRMA, the trade association for research- based pharmaceutical and biotechnology industries in the United States. We are pleased to have the opportunity to share with this subcommittee our industry's views on the development of a protocol to the Biological Weapons Convention. PhRMA appreciates the very complicated challenge that the signatories to the BWC face in trying to assemble a protocol that provides any level of confidence for either compliance or verification of the BWC. We welcome the opportunity to work with the subcommittee---- Mr. Shays. Doctor, you can just move yours. I rarely have the occasion to ask someone to move it away. Just step it 2 inches away. Ms. Woollett. We welcome the opportunity to work with the subcommittee as you explore and deliberate these very important issues. PhRMA concurs with the goals and objectives of the BWC and has been actively supporting efforts to strengthen this convention by the inclusion of effective measures to help enhanced compliance with its objectives and to reduce the threat of biological warfare. Indeed, the global pharmaceutical, chemical and biotechnological industries join others in their belief that biological weapons represent a serious and increasing danger to people around the world. Since very similar microorganisms to those used for legitimate purposes could be misused as weapons of mass destruction, we accept that a protocol strengthening the BWC cannot exempt private industry. However, the pharmaceutical and biotechnology industry does not make biological weapons. Our very purpose is the opposite. We make products to counter unmet medical need, of which a substantial proportion continues to be infectious disease. To compromise our ability to develop medicines or to undermine patients' confidence in those medicines without a definable level of confidence in the proposed protocol would be a tragedy for public health. The chairman's text unduly targets vaccines and culminates in requirements that not only compromise our industry's ability to research and manufacture medicines but also establishes mechanisms to expose confidential business information. Measures strengthening the BWC should ensure the inhibition of any misuse of microbiology without impairing its legitimate lifesaving uses. We should encourage development in areas such as health care, agriculture, nutrition and the environment. Our concerns with the protocol include the scope of declarations and onsite activities and the degree to which the burden is balanced by its value for arms control purposes. Declaration formats must be simple and without requirement for disclosure of any confidential business information, and their use must be apparent in impeding biological weapons creation. Unfortunately, these criteria are not met in the current chairman's text. The current triggers in the chairman's text are ambiguous and the focus is on those facilities with greatest legitimate capabilities. Furthermore, the declarations are extensive. The format is confusing, and they will require inclusion of confidential business information. PhRMA urges that clarification procedures between the International Secretariat and the state party be established in anticipation of questions about declarations. However, we believe these procedures should not require any additional onsite activities. Since the nature of microbiology is such that it is often easy to remove traces of any development, manufacture, or storage of a biological weapons agent, any routine onsite activity is not a useful concept under the protocol. However, our industries are sympathetic to the concept of nonroutine, nonrandom familiarization or educational visits, provided they are voluntary and under full control of the company visited. In the event of alleged serious violations, it may be appropriate for the international community to conduct a challenge inspection, but malicious or frivolous claims of violations must not precipitate intrusive onsite activities. Challenge inspections must be conducted according to an established due process that is evidence based. Strict managed access must be employed, and the inspected site must have the final determination of what is proprietary information. If no evidence of a violation is found, this fact must ultimately be reported by the International Secretariat. The global pharmaceutical, biotechnology and chemical industries have tried to participate actively to reduce the threat of biological weapons. Working globally with our respective governments and international negotiators, our companies believe that our industry can help strengthen the BWC and reduce the serious threat to people around the world. Unfortunately, the chairman's text, as proposed, strongly suggests that our input to date has fallen on deaf ears. As you deliberate this difficult topic, we urge that you include the needs of patients and their intimate relationship and confidence in our companies in the equation. More and better medicines are dependent on the ongoing research and manufacturing capabilities of the U.S. pharmaceutical and biotechnology industries. A global leadership is a credit to the United States and not something to be intruded upon in the search for biological weapons, which are clearly an anathema to our industry. One of our industry's greatest contributions to public health has been human vaccines, and yet vaccines find themselves in the bull's-eye of this protocol. How can that help global security? Thank you. Mr. Shays. Thank you, Dr. Woollett. [The prepared statement of Ms. Woollett follows:] [GRAPHIC] [TIFF OMITTED] T0137.027 [GRAPHIC] [TIFF OMITTED] T0137.028 [GRAPHIC] [TIFF OMITTED] T0137.029 [GRAPHIC] [TIFF OMITTED] T0137.030 [GRAPHIC] [TIFF OMITTED] T0137.031 [GRAPHIC] [TIFF OMITTED] T0137.032 [GRAPHIC] [TIFF OMITTED] T0137.033 [GRAPHIC] [TIFF OMITTED] T0137.034 [GRAPHIC] [TIFF OMITTED] T0137.035 Mr. Shays. Colonel Kadlec. Colonel Kadlec. Thank you, Mr. Chairman, members of the subcommittee. It is a great pleasure to be here today, and it looks like I am the cleanup batter for today's panel. But before I begin my formal remarks, I'd like to remind you that I am here on my personal auspices, and my views are solely my own, not of the U.S. Government, Department of Defense, National Defense University, or the U.S. Air Force. To give you a little background in terms of my reason to be here is that I served on the U.S. Delegation to the Biological Weapons Convention from 1993 to 1996, participated in several of the aforementioned U.S. department-sponsored trial inspections, and also served as a U.N. Special Commission inspector in Iraq in 1994, 1996 and 1998. Mr. Shays. And, Colonel, right now you are a professor at the War College? Colonel Kadlec. That's correct, sir. Mr. Shays. So you are coming as a professor from the War College with your own views? Fine. Thank you. Colonel Kadlec. Thank you. To maybe address specifically the issues that you raised in the letter that I received to attend today's panel discussion, the first and foremost was how did the United States develop a verification policy for the U.S. BWC protocol? I think Dr. Zelicoff's comments touched on maybe some of the more finer points, but I think in quick summation, the fact is we really didn't have a clear articulated strategy or approach for the negotiations, and that clearly had a partial paralysis on the events on the ground in Geneva. It clearly hamstrung the delegation to either accept or reject positions that were being offered. It certainly limited our ability to project positions in that--into national fora. And more significantly, I think it had an impact on limiting the kinds of things we could be doing back in the States, particularly national trial visits, that would have helped us understand the implications and consequences of some of these measures as being proposed. I think it's just worthy to note that the Department--or Department trial visits that were conducted were sponsored by specific government departments rather than the U.S. Government at large, principally because there was no consensus, and certainly there was no endorsement of those trial visits and the reports and subsequent findings that came out of those. So in the end I think, simply put, we were very limited in what we could do. As far as the current draft protocol and whether it would be possible or whether it would be able to detect or deter rogue nations or terrorist biological weapons activity, I would judge that to be a low probability. Two principal reasons, and one is inherent in the protocol and the other one is inherent in, if you will, the nature of biological arms. First, the protocol is certainly not comprehensive in its inclusion or coverage of facilities of concern. I think it's noteworthy that universities and many other facilities, food processing facilities, are not included in that, and that there are certain, if you will, arbitrary distinctions or criteria that exclude R&D facilities or even small possible production facilities. It's still a matter of concern but would not be necessarily a matter of disclosure--voluntary disclosure through this protocol. The second part is, it's certainly the ambiguities that are inherent in these activities. I always remind myself that the original drafters of this convention back in the mid-seventies, essentially seventies, did not include verification measures, not because they didn't want to, but because it wasn't easy, and certainly not clear then. And I would suggest that in some ways it is less clear today because of the advances in biotechnology that really provide great efficiencies and great capabilities in facilities that were not considered, or even unheard of back in the 1970's. So with that as a backdrop, I would suggest that at least for detection purposes, we may be better off, as Dr. Rosenberg, to rely on our national capabilities within the intelligence community. And maybe that's where we would be better served to make investments to strengthen those capabilities that could detect those proliferators pursuing these weapons, particularly in the human intelligence side. The issue of deterrence is a little more complicated, principally because, as you well know, deterrence is based on not only a capability but also a credibility of whatever tool you have, particularly in this case the protocol, and that would be the specific measures that it offers and the procedures that it offers as well. It goes without saying, it would probably--if it's unlikely to detect a cheater, it's probably unlikely, or very low probability, to deter a cheater. In that sense, I think, again, we may look to other investments to see if we can bolster our capabilities. And, again, if you look at this protocol as part of a larger national strategy, the technical side of this is such that I would probably defer to other means to give us confidence in whether or not the treaty is being complied to. Your issue about the extent to which the protocol will improve verifiability of the BWC, I think it's a--I would say it would be bold to advocate, and I think it is the consensus here that it's probably not verifiable, but I would point out that there also may be an unintended consequence of this effort. And that is principally in if a state's party complies with the protocol, does that necessarily mean that they comply with the treaty? And that is a potential sleight of hand that could be used by countries that are certainly suspected of those intentions. Clearly in the course of negotiations, Iran was one country that tried to make a case--and it will be unclear until the end game whether they went out on this--that they could somehow trade, if you will, their compliance with the protocol with the abolition of multilateral export controls. And that is just one possible outcome that needs to be considered. Finally, your last point is related; specifically, what additional mechanisms could be used to strengthen the effectiveness and improve implementation of the Biological Weapons Convention. And there are two. I would like to endorse the comments made earlier by Dr. Zelicoff and Dr. Rosenberg on the fact that it seems like an odd paradox that the treaty that is entirely devoted to the deliberative use of disease as a weapon does not have any provisions to either create, expand, or mandate systems to monitor disease occurrence. And this is clearly one area that probably deserves more consideration and certainly would be one that would--could objectively not only strengthen our nonproliferation goals, but certainly strengthen our national and international public health objectives as well. My last comment is directed to an issue that has been touched on lightly here, but certainly where my experience weighs heavily, and that is through the United Nations Special Commission. I would just like to point out that the verification of experts exercise that was conducted in the early nineties, that basically produced the foundation for the draft protocol and identified 21 possible measures both onsite and offsite that could be used to strengthen the compliance with the treaty, were actually all employed during the experience in Iraq. What is interesting to note, and I guess in part it's maybe part of the cognitive distance that was existing in the U.S. Government, but certainly the fact that chronological experience was that they were parallel events that sometimes operated, I won't say completely independently, but certainly sometimes detached, and that is a systematic comprehensive review of the UNSCOM lessons: clearly what worked, what didn't work, and clearly making that as a benchmark to assess whether or not a future protocol--whether this protocol or any protocol could address these purposes. Until, I think, we assess that and certainly conduct more government-sponsored trial visits, it will be very difficult, I believe personally, to negotiate or commit to any protocol that is both sensible or effective. Thank you, gentlemen. Mr. Shays. Thank you, Colonel. [The prepared statement of Colonel Kadlec follows:] [GRAPHIC] [TIFF OMITTED] T0137.036 [GRAPHIC] [TIFF OMITTED] T0137.037 [GRAPHIC] [TIFF OMITTED] T0137.038 [GRAPHIC] [TIFF OMITTED] T0137.039 [GRAPHIC] [TIFF OMITTED] T0137.040 [GRAPHIC] [TIFF OMITTED] T0137.041 Mr. Shays. Mr. Schrock. Mr. Schrock. Thank you, Mr. Chairman. Again, thank you all for being here. This is a frightening subject to me, and it's something I had not thought much about until I came to Congress. I was privileged to serve in the Navy for 24 years, and what we worried about in Vietnam were the Viet Cong; we didn't worry about chemicals and biological-type things. But I think the real enemy we're going to have now is that, and I don't know how the devil we get our hands around it, and I am concerned by that. I have a comment for the Colonel, but I wanted to start with Dr. Zelicoff. When the administration officials last appeared before this subcommittee, one of the witnesses--I believe it was Ambassador Mahley--said, ``the United States has never judged that the protocol would produce what is to us an effectively verifiable BWC.'' In other words BWC is not verifiable. Help me understand what the technical meaning of ``effectively verifiable'' is and to what extent is it verifiable? Mr. Zelicoff. You will never get a U.S. Government agency to define what ``verifiability'' means. I have tried. Mr. Schrock. I'm sure. Mr. Zelicoff. But I do believe that there is consensus, and I would hazard a guess there is even a consensus on this panel that verifiability has a certain minimalist standard, and that is that it's more likely than not to catch a cheater before he's able to do something disastrous with his biological weapons and--and this is equally important and always ignored-- more probable than not, to not accuse somebody of violating the treaty when in fact no violation has taken place. Now, as a scientist, we refer to those things as--we have terms for them. We call it the sensitivity and the specificity, but you can think of it as the likelihood that you miss something and the likelihood that you make a mistake by falsely accusing somebody. With that minimalist definition--that is, both being able to have a more probable than not standard for finding a cheater before he's able to do something significant--I don't think that there is any question that the treaty does not--or the protocol does not meet that verifiability standard. With regard to the more problematic issue, that is, falsely accusing somebody, what we learned very clearly in the U.S. trial inspections--which I have to say were conducted in a scientifically credible way, meaning that they were blinded, meaning that no one who participated as an inspector knew anybody who was at the inspected facilities, and other such reasonable precautions to prevent bias--what we learned clearly from those was that the probability of coming up with an ambiguous result--that is, walking away with less confidence that the site was in compliance--was actually the biggest problem. In other words, it is highly likely that if a properly, or improperly I should say, politically motivated inspection team came to a U.S. pharmaceutical facility they could see anything they want to see and make a story that is completely in their view credible for biological weapons violation even when no such violation is taking place. That was precisely what happened to us when the U.S. trial inspections took place at a small vaccine facility in Michigan, a very modest facility by comparison to the average pharmaceutical facility in the United States, and indeed the report of the team, which we were not allowed to release in Geneva, was that the team was less confident that the facility was in compliance after than before visiting. So on those two standards of verifiability I think the trial inspection experience is clear, false positives and false negatives are very, very likely. Thank you. Mr. Schrock. If it isn't verifiable, why have a protocol? Mr. Zelicoff. That is not for me, I assume. Mr. Schrock. It will stop shortly. Mr. Zelicoff. It depends on what your goals are of course. If your goal is verifiability, then you should not believe or sign up to a protocol like this because it doesn't deliver the goods. If the goal is something less than verifiability; for example, improving confidence, then one can select among the measures that are available that I think over time would generate an increased belief of the credibility of the enforcement of the treaty. But now we start to get into judgments that as a scientist I am not prepared to make. Mr. Schrock. Colonel, I am probably going to paraphrase here and I like a comment I think you made, you said rogue nations are likely not to use chemical-biological warfare. Did I misread you? I thought I would sleep better tonight because of that. Colonel Kadlec. No, sir, I did not say that and I wouldn't endorse that at all. My apologies if I left you with that impression. Mr. Schrock. Well, I'm glad you cleared that up, but I'm sorry it's not true. That's all, Mr. Chairman. Mr. Shays. We have had two visits to Geneva, we have had one other hearing and we have had a lot of research done and we have had the GAO and others report to us on this issue, and I am left with a feeling myself after this brief kind of introduction to this issue, I don't honestly know how you verify. And as we start to go through the panel I got the feeling, Dr. Zelicoff, that you don't like the BWC protocol as written and that you wonder whether you can verify. Dr. Smithson, I get the feeling you don't like the protocol as written but you think something needs to happen. Dr. Rosenberg, I get the feeling that you are very strongly supportive of the protocol and you think it is clearly the way to go. And Dr. Woollett, I get the sense that you don't want verification inspections. That's the general sense I get. And Colonel, I get the sense that you don't think the BWC protocol will work. That is the general sense. So it is kind of like in a scale here, panel, three against one--kind of against but something needs to happen, and one and four. Ms. Rosenberg. Can I correct what you said about me? It is not exactly correct. Mr. Shays. I understand. It may be that all of them aren't correct. By the way, any question that I ask one any of you are more than welcome to respond to. Before you take that, maybe any comments that any of you wanted to make to the previous questions that were asked, if you wanted to jump in to respond to the questions that my colleague asked. Why don't we start there and then we will deal with my summation of where you stand. Anybody want to jump in on anything that was asked? Ms. Rosenberg. On the question he asked? Mr. Shays. Yes. Ms. Rosenberg. Yes, you asked why--if verification is impossible why bother with the protocol? Because the protocol does something else, as I tried to point out. It can raise suspicion or it can allay suspicion, it can increase confidence. It increases transparency, and this is something that is not verification in the strict sense, where you prove that there is no violation or full compliance, but it adds to all the other national capabilities that we have. It is an additional tool. It has been pointed out there is a web of deterrence that involves a series of different things like export control and national intelligence, military preparedness, defense, and the protocol is another tool in that web which gives us additional capabilities and feeds in so that it helps us to focus our intelligence on the facilities that might not have been recognized as being a problem but that something might come up, or to eliminate bothering with some that we feel convinced are OK as a result of protocol procedures. Ms. Smithson. I would like to address the question about whether or not we can go forward and should we go forward with this. At present we are dealing with from the U.S. perspective really two data points. The two trials that the United States has conducted I think are certainly the most robust ones that have been conducted internationally. And what worries me is we have incorrect data points in that we seem to be throwing up our hands at this juncture. When you can't figure out something, quite frankly you try harder to figure it out. And the technical experts who sat at our table were certainly very familiar with what inspections were all about, especially those from industry. Those are individuals who have inspectors in their plants all the time. They get no-notice inspections. They get inspectors there for weeks at a time and they know how to make things work for the host facilities and for the inspectors. And I'll take their advice on this. They are encouraging the U.S. Government and industry to actually get out there and do the grunt work required to figure this out, conduct the field trials, work harder. Ms. Woollett. I think I have to make a comment at this point that PhRMA has expressed a willingness over a number of years. But what are we actually modeling? If we have to model some method by which we prove ourselves innocent for the reasons that Al Zelicoff has discussed earlier, that is simply not doable. Our capabilities, should we be so inclined, are so much more than would be needed. There is no way we can prove that we haven't ever made a BW. We can affirmatively show what we do indeed do. We can show we can make medicines but we can't show that we haven't used the facilities for illicit purposes. So the moment you have a lack of presumption of innocence, no facility, however capable, can prove it hasn't made BW. So I think this is the fundamental quandary as to what actually inspections are for. That's what the text doesn't resolve, particularly in terms of its routine inspections. Mr. Shays. Dr. Rosenberg, you wanted to respond to my characterization. Ms. Rosenberg. Yes. You said that I, and I presume my group, are strong supporters. We are supporters of a protocol. The chairman's text is a good deal weaker than we would like to see, much weaker. We know there could be a much better protocol out there, there could have been. The problem though is not technical. It is political. This is the best protocol we can get at this time and for some time to come, and it is better to have something than nothing because otherwise we are telling proliferators that they can go ahead with impunity. Mr. Shays. I am going to use Dr. Zelicoff's comments to generate dialog with the four of you. It doesn't mean, Dr. Zelicoff, you can't comment either. First I am going to read: You said, doing something should never be confused with doing something useful. But--this is a long paragraph but I would like you to listen to it and then I would like you to comment on it. You were referring, I am on page--no pages, doctor; you automatically drop from an A to a B if I were grading you. I have no pages on this. But at any rate, despite these valuable results the process of policy development with U.S. Government protocol negotiations soon faltered. You say it is not a very well kept secret that there was intense friction between the Security Council by the entirety of the Interagency Working Group on Biological Weapons Control through the past 8 years while the policy was under development. Then you say essentially nothing in the way of tangible policy was put forward during this time because one or at most a few low level staffers within the NSC sought to suppress the results of the mock inspections, break interagency consensus on negotiating strategy and impose an extraordinarily ill-suited vision for the BWC protocol which was make it like the Chemical Weapons Convention. I'm still going to read on. Nothing could be more wrong- headed for all the reasons that you have heard in last September's testimony; nothing could be more destructive for the future of the BWC. There is no question that there was a complete absence of serious administration attention to the negotiations taking place in Geneva. Otherwise, the grating questions about goals and tactics that haunted all members of the delegation for all of the last 8 years would have been resolved. That low level NFC functionaries were able to force gridlock speaks volumes about the lack of leadership for and periodic review of the U.S. negotiating stance throughout most of the 1990's. I will just tell you this summarizes my feeling about my observation of the negotiations that have taken place during the time that I followed, and I have no sense ultimately of what we hope we can achieve, frankly. But let me ask you to comment on this, all of you. First, Dr. Zelicoff, do you still believe this? Mr. Zelicoff. I do, sir. Ms. Smithson. I would applaud Dr. Zelicoff's candor, as someone who spends a great deal of time watching the U.S. Government attempt to make decisions and often bumbling what they do. His description here I believe is right on target, so I will agree with it in total. Ms. Rosenberg. I did talk about this in my written testimony. I agree. I think we all recognize that there was no high level leadership during the course of these 6 years of negotiations, that although President Clinton issued several statements in support of the goal, no one at the top levels pushed it. It was left in the hands always of lower level officials. And in the interagency group each one had his own turf to protect and nobody took the common interest as an overview, and I think that is a very sad commentary on our government. Mr. Shays. Dr. Woollett. Ms. Woollett. I think your question of what do you achieve is absolutely critical because this will be a balance of what is put at risk, what is the burden, what is the cost on whomever verus what you achieve. We're able as industry to assess the risk to our patients, to our products. What we don't understand is the arms control aspects. What would this do for global confidence that we wouldn't have if we were left with just the treaty, which, remember, is those people who've agreed not to do this stuff in the first place. So we are only talking about a subset of the world anyway. So our question is fundamentally the same as yours: What would you achieve with this protocol that you wouldn't have otherwise? Colonel Kadlec. Sir, I would concur with Dr. Zelicoff's assessment. I would add, and again to expound on the point of the chemicals weapons inspection, that there seem to be, and again this is one of the cultural-technical differences between the two communities of chemical versus biological processes that seem to get often blurred, which is somehow you can take it by direct extension and extrapolate it to the biological processes, which I think is fallacious, and I think Dr. Zelicoff pointed that out. I would also add that there was a certain level of idealism here that somehow you can go much further than you could with this. And I would like to go back and address the point made earlier, the question asked earlier about why have a protocol and certainly Dr. Smithson's point about specifics as it relates to doing national trial visits. You may or may not recall a place called Al Hakam, but that was a facility that the Iraqis declared in 1991 after the Gulf war. It was the site of intense scrutiny by the U.N. Special Commission over a number of years, thought to be very suspicious because of the nature of the layout, physical features. It was dispersed, there were unground bunkers, there were anti-aircraft sites around it. But it was not until 1995, despite numerous challenge, routine monitoring inspections of that facility that truly the clear intent behind that was known based on Hussein Kamel's defection. And I just highlight that as one of those key points, that if you use traditional arms control approaches, as we do in other disciplines, I think you will come up short. And in fact in some ways you may wish to reserve those capabilities. And when you look at a protocol it would seem the challenge mechanisms that allow you to get to the kind of situations that were encountered in Sverdlovsk in Russia in 1979 or certainly if there were an equivalent occurrence of the use of chemical weapons in Iraq or against Iranians, that there would be a mechanism outside the U.N. Security Council to ensure that those things could be promptly and fully investigated. Mr. Shays. You made reference to an individual. Was that one of Saddam Hussein's son-in-laws? Colonel Kadlec. Son-in-laws. Mr. Shays. And what we learned from both of them coming forth was that there was a site that was not disclosed? Colonel Kadlec. Well, sir, Al Hakam was disclosed. It was declared by the Iraqis, but the true intent and purpose behind that site was never known. I left out one important piece of the story because during the course of the 4-year, if you will, monitoring by UNSCOM the Iraqis actually were building a new site on that facility that gave it an incredible fermentation capacity of 50,000 liters and this was done under the watchful eyes of UNSCOM. It was given a nominal cover, if you will, of being a single cell protein facility to make cattle feed, for which everyone suspected that was not indeed the case but the smoking gun was elusive, and even under the most stringent provisions that were ever created for arms control through the UNSCOM and through the U.N. Security Council Resolution 687, that was not really appreciated until someone from the inside came out to basically disclose what the purpose of that facility and site was. Mr. Shays. We do have a clock on now, but Mr. Tierney has joined us and I am eager to have my colleagues jump in. But let me make sure that I am not, that we are spelling it out. Is it your testimony before us that without an insider you could basically disguise the use of the facility even with the inspections? Colonel Kadlec. Sir, again that's the practical experience that came out of that episode. I think again Dr. Zelicoff touched on the point of intent, that it is very difficult to look at a fermentation kettle that is used for vaccines that may well be used in 7 days or 7 hours after the inspection team leaves to produce something other than a benign vaccine, and again it is the dual use nature of the problem. Ms. Rosenberg. I have talked with some of the inspectors who entered that single cell protein plant, so called, and who said they only had to step inside to recognize that this was something much more than a single cell protein plant. They didn't know exactly what it was and we did not find that out until after the defection. But the point I would like to make is that we knew Iraq was up to something. We knew we had to keep our eye on them. And that is the kind of thing that the protocol can do. It will not give us the full answer, but the important thing is that we watch them so they don't go beyond. Mr. Shays. Dr. Smithson, did you have a response? Dr. Rosenberg, I am sorry, I am going to ask you to repeat your last point. I got distracted. Ms. Rosenberg. I said that I have spoken with inspectors with UNSCOM who entered that single cell protein plant that Bob mentioned and they could tell immediately that plant was something more. Mr. Shays. I got that part but then you made another point. Ms. Rosenberg. Yes, and even though they did not know exactly what it was for they knew that the Iraqis were lying. They knew they were up to something and they knew enough to keep their eye on it and to keep looking and to focus on preventing them from using that plant for some illicit purpose, which they succeeded in doing. So I think this is a good example of what the protocol can do. It may not give us the full answer but it raises suspicions that will allow us to keep our attention on possible trouble points. Mr. Shays. I will let both of you respond, but I have an observation, that I am wondering if only the human intelligence can detect the wrongful intent of violating the BWC. In other words, there are building signatures and you can't determine intent, say, from a satellite photo or hear intent on an e-mail interception. It seems to me that you almost need an insider to say bad things are happening here. Without that insider you are going to have a problem. Ms. Rosenberg. An insider or an inspector from a regime like the protocol would set up. Mr. Shays. Because I think that an inspector, they close down the operation. Ms. Rosenberg. But that doesn't matter, you see. We are not doing anything I believe at this plant that Bob mentioned. You don't have to see it operating. It's capabilities that count. It was much too, what's the word, it had capability that wouldn't be needed to make single cell protein. It was much too elaborate for that. And the inspectors immediately recognized that this could be used for something other than what they said it was. Mr. Shays. I am going to jump both of you for a second, but the bottom line is isn't that the problem. My limited understanding of this issue is if you have dual uses it can be used for something other than a legitimate use. Ms. Rosenberg. That's right, but the point is you have to declare in a regime--like the protocols, you have to declare what is the use and there's evidence. If you say you're making a pharmaceutical you can find out what's on the market that is coming out of that place, you see. So you have a lot of other evidence with which to compare the capabilities and if they are beyond what are needed that raises suspicions. So all right, you don't bomb them, but you keep an eye on them. Mr. Shays. Mr. Tierney. Mr. Tierney. I just want to followup on that. You go on. I am looking at some of the comments that Ambassador Mahley made not too long ago. There is a real value in increasing the transparency associated with biological activity. This could in our view complicate the efforts of countries to cheat on their Biological Weapons Convention obligations. The United States believes investigations are one of the most essential elements of a BWC transparency regime. Actually talking to scientists and production workers on the ground as well as observing the atmospherics at a facility are ways for experienced observers to detect anomalies. One can never discount either the whistleblower prospect of an employee or the ineptitude or a coverup of an illicit activity. While there is no likely way to judge the likelihood of such an outcome, the deterrence component is useful since it complicates the life of a potential proliferator. I see in that what you are talking about, but I also wonder what has changed in the Bush administration to all of a sudden back off these comments made by the Ambassador. What's happened in the interim on that? Why is that still useful? We understand that they are not fool proof and they're not absolute, but there are advantages in moving in this direction. And what has changed on that and why would they pull their witnesses today, who would be able to expand on that? And Ambassador Mahley might be able to tell us if in fact he has had a change of heart there. Ms. Rosenberg. Well, I think we have to consider the possibility that this administration's policy here is not determined by the logic of this particular situation but by an ideological view of arms control in general, particularly multilateral. Mr. Shays. Dr. Rosenberg, in all fairness before Mr. Tierney came here you acknowledged that for the last so many years there has been no movement forward. Ms. Rosenberg. I did, yes. Mr. Shays. Let me just finish this one question. Ms. Rosenberg. Let me say a pox on both your parties. I think the common interest calls for doing something on biological weapons and I don't think either party is pushing appropriately. I am not standing behind either one. Mr. Shays. Mr. Tierney asked if I was happy now. Let me have both of you respond. Ms. Smithson. I too have spent a fair amount of time in the company of individuals who served on the United Nations Special Commission inspections. One of the things they told me time and again, as well as the individual who went into Soviet facilities, is that literally the minute they walked in the door they knew they were in the midst of something that didn't walk and quack like a duck. In other words, they were in the middle of biological warfare facilities, and that is one of the most important things that these inspections may be able to tell us if we actually figure out the right way to do them. As for the application of the satellite assets and SIGINT and MAZINT and other types of capabilities, I fear your suspicions are probably correct. We may not be able to tell as much from those capabilities as we might have been for other types of weapons of mass destruction. And in terms of work that was done in our brainstorming sessions, one of the things that all groups of experts that sat around our table consistently pointed out is that if inspectors went in the door one of the things they would look for would be inconsistencies with a stated purpose. This would be waste treatment capabilities beyond the needs of the facility, containment capacities beyond the needs of the facilities or less than what they stated they needed, or other types of activities or capabilities at a site that simply didn't fit with what they said they were doing, in their multiple ways that these experts from industry, from research institutions believed that this could be tracked through monitoring procedures. We just need to work harder to figure that out. Mr. Shays. Dr. Zelicoff, do you want to make a comment? Did you forget what it was that you wanted to make? It was a while ago. Mr. Zelicoff. I don't think so. I have to respond to several things that Barbara said because I think we are going down a path---- Mr. Shays. You have to use last names. I am not on a first name basis, so I am forgetting who Barbara is. Mr. Zelicoff. Dr. Rosenberg. Mr. Shays. I'm sorry, I would like to be on a first name basis with the doctor, but not yet. Mr. Zelicoff. We are going down a path that I don't think is particularly useful for the work of the committee. When I was practicing medicine we had a diagnostic tool that was 100 percent likely to find a disease, and it was called the 20-20 retrospectroscope. We would practice it all the time, and I am afraid that is what we are hearing right now with regard to the Iraqi UNSCOM program. Let's be clear, but for the defection of Kamel Hassan we would not have had any idea of where to look and what to look for. Mr. Shays. I might say he was a whistleblower that had his head chopped off. Disincentive to whistleblowers. Mr. Zelicoff. That is correct. But even if it were true that we could go into a facility and smell something rotten, I want you to consider that biotechnology has advanced enormously in just the past 5 years. I suspect that if the Iraqis are carrying out a biological weapons program or if the Russians are carrying out a biological weapons program, they are not doing it like they did it even 5 years ago. Large scale fermenters, facilities for waste treatment, all of that is passe. It is completely irrelevant and this is simply because of the advances in the modern tools of biotechnology which require no large scale facility, don't require any special kind of equipment and could easily be done in a laboratory that would be a tenth the size of this room. Indeed, the Russians in particular have adopted what they call a just in time philosophy for biological weapons. They no longer brew up large batches of anthrax in enormous fermentation facilities. Rather, if the need should arise, the Russians plan to make their biological weapons en route to the front on rail cars. Small facilities can take tiny amounts of biological material, a few organisms, and have hundreds of pounds of organisms like anthrax in just a number of days. Now let me return to something Mr. Schrock said because I think this is the way the committee ought to look at the utility of a measure being proposed in the current chairman's text. Whenever a measure takes place, it is very much like a medical diagnostic test. So I will give you an analogy that I think is apropos here. That is to imagine doing a cardiac stress test on everybody sitting up there. I will lay you dollars to doughnuts, and that would include the people sitting along the wall, that at least one of you will have a positive cardiac stress test. Does that mean that person has coronary disease? Absolutely not, because the test has about a 5 percent false positive test. So if you do it 10 or 20 times it is improbable that you not get a positive even though the person does not have a coronary disease. I state this to emphasize an important point. When you carry out a measure or combination of measures and call those measures a protocol, there are three possible outcomes. The protocol could make the treaty better. The protocol could have no effect whatsoever on the treaty. The protocol could make the treaty worse. How could it make the treaty worse? By generating numerous false positives that both undermine the political consensus for the treaty as well as undermine the technical validity of those tests. This is precisely why Ambassador Mahley referred to certain measures that could be useful for increasing confidence but they do not meet the standards that we associate at least minimally with verification. In particular, I think I want to summarize the one point that I think everybody on the panel agrees on. We can make the Biological Weapons Convention and the world a much better place if we can somehow enhance disease monitoring. I think that is obvious how that will help public health. But to address Mr. Schrock's point, will it verify the convention? No. However, on those rare occasions, like what happened in Sverdlovsk in 1979, when there is an accident or an experiment gone awry, or even a potential test of a biological weapon, should disease take place in either animals, human or even in plants, I am as confident as I can be about anything in science in saying that I am quite certain that the tools of modern epidemiology can separate a naturally occurring event from a man-made or intentional event. Will that verify the treaty? No, because those episodes are rare. In fact to the best of my knowledge, we have only had one. However, what it will do is set us down the path of enhancing disease monitoring, which will indeed complicate the activities of someone who wants to violate the treaty because ultimately they will have to test. Mr. Shays. Interesting point, but if we are disease monitoring then the disease has already taken root. Mr. Zelicoff. Correct. Mr. Shays. Mr. Tierney, you have the floor for as much time as you want. Mr. Tierney. Thank you, Mr. Chairman. Thank you for having these hearings. I will just ask the chairman one question. I am a little late in getting here and I apologize for that. First of all, have the testimonies of Ambassador Sheaks and Ambassador Mahley that were submitted for the panel that did not occur, have they been put on the record yet and, if not, may we by unanimous consent put them on the record? Mr. Shays. Sure, we will put them on the record; just note that they weren't put under oath but the testimony is obviously submitted by them and they will be put on the record. Without objection, so ordered. [The prepared statements of Ambassador Sheaks and Ambassador Mahley follow:] [GRAPHIC] [TIFF OMITTED] T0137.042 [GRAPHIC] [TIFF OMITTED] T0137.043 [GRAPHIC] [TIFF OMITTED] T0137.044 [GRAPHIC] [TIFF OMITTED] T0137.045 [GRAPHIC] [TIFF OMITTED] T0137.046 [GRAPHIC] [TIFF OMITTED] T0137.047 [GRAPHIC] [TIFF OMITTED] T0137.048 [GRAPHIC] [TIFF OMITTED] T0137.049 [GRAPHIC] [TIFF OMITTED] T0137.050 [GRAPHIC] [TIFF OMITTED] T0137.051 Mr. Tierney. Thank you. Is there some indication that the Ambassadors will be with us soon so they can testify before the committee? Mr. Shays. Yes, they asked for a postponement until the administration is totally certain in what direction they want to head and they feel that will happen in the next few weeks. And let me say to the gentleman, we will call them before the committee. Mr. Tierney. Thank you. My concern is of course this will be at least the third instance of when this administration has unilaterally pulled back from an international commitment that people in other countries thought they had some right to rely would at least be consulted and have the issue discussed with them before such action was taken. You have the Kyoto Accords and the national missile defense situation and now this. I would like to see us have a more cooperative attitude and relationship with people in dealing with an international respect for our own credibility and for the sake of trying to move forward on some of these. I get the sense, Mr. Zelicoff, that you don't feel that any protocol is useful in this or am I overstating the case? Mr. Zelicoff. Yes, I'm sorry you weren't here earlier. You are overstating the case. I do believe that a protocol that focuses on challenge inspections for specific cause as opposed to routine random inspections for no cause at all. Mr. Shays. Could I ask you to defer? Don't be offended by someone. A Member is in many places and I don't want to discourage a Member from asking any question if they weren't here. I just want to say to all the panelists this gentleman works very hard and he may ask a question and we'll just repeat it. And frankly it takes me three times to understand it, so it is good reinforcement for me. Mr. Zelicoff. Thank you. And the second item, Mr. Tierney, was enhanced disease surveillance, and I believe that would make a very credible protocol. Mr. Tierney. As that was just discussed--while you are saying that, I have the same thought the chairman had and that is sort of after the horse is out of barn and a little bit tough in doing as much good collectively in that. Going back to your first issue, how do--is the only way I'm going to know to challenge it--how am I going to make a challenge if I don't have any information from inspections or other activities? Mr. Zelicoff. Through the usual means, which tend to be national technical means or some sort of evidence that an accident has taken place. It is a tough problem. Mr. Tierney. Again, a situation would have to occur, an accident or something like that, to give us an indication. Mr. Zelicoff. I wouldn't rule out the possibility of intelligence identifying a site that is high probability for violation. Mr. Tierney. Dr. Smithson, do you agree? Is that your position also? Do you have other reasons or other ways that you think we might move forward on this? Ms. Smithson. The groups of experts that sat around the Stimson Center's table from industry, from research institutes, from academia, from defense contractors and also veterans from various types of inspection activities would all advise that this chairman's text be rejected simply because it's not strong enough to do what we would like for it to do. However, they would also ask that the U.S. Government and U.S. industry go forward with rigorous field trials and additional technical research to ascertain what can be done. And two of those groups, those from academia and from industry, strongly believe, in fact laid out their monitoring strategies for how inspectors could differentiate between legitimate facilities and those that might be cheating and to do this on a reliable basis. Mr. Tierney. Would they rely on inspections for this? Ms. Smithson. Absolutely. Mr. Tierney. Would it just be inspections for cause or interim inspections, periodic inspections? Ms. Smithson. It would be both types, challenge inspections if cause were demonstrated or if intelligence indicated there were cheating taking place as well as a more routine type of inspection. In fact, the defense contractors, academics and the industry groups all did not want this to rely solely on challenge inspections. They believe that routine inspections are needed. Mr. Tierney. For your own personal opinion on that, is there any way that this protocol could be saved if we extended out the date beyond November? Is it something that could be worked with and have a result that was more in line with things that would be acceptable for the group she talked about? Ms. Smithson. If I had a nickel for every time I heard someone say if we don't seize this window of opportunity all chance will be lost and we will lose the agreement, well, I would be a very wealthy woman. I don't believe that we need to hurry this thing and get it done by November. I would rather have us get it right than get it fast. And unfortunately, to do so will take more time and effort on the part of the U.S. Government and U.S. industry so, yes, this can be salvaged but not necessarily with the formulas that are currently on the table or the technologies that are currently being discussed. Mr. Tierney. Dr. Rosenberg, what do you feel about postponement versus moving forward with what is on the table now? Ms. Rosenberg. I would like to see the negotiations continue, but what I would like isn't the point. Mr. Tierney. No, but it is interesting and it helps. Ms. Rosenberg. I am familiar with the negotiators. I spend a lot of time over there and I know our allies are fed up with the whole process. They feel that they have been foiled at every turn by the United States. They have tried to make a strong protocol. The United States has insisted on weakening it. Now the United States says it is too weak. They just don't see any point in continuing this charade. So whether it is going to be possible to continue I have very strong doubts at this stage, and that is why I think we should take what we can get now if possible. I also want to comment on what Dr. Zelicoff said, at least if I understood him correctly, that a good protocol would be one that would concentrate on challenge inspections. I know this is widespread thinking in the government right now. I want to point out that challenge inspections are a very political mechanism, that there have been no challenge inspections under the chemical weapons inspections that has been enforced over some years and there is thought that maybe there never will be because the longer it is put off, it's also likely the more fear there is to bring a challenge. Second, there is also a mechanism for investigation of an alleged use of biological weapons. Under the United Nations there is a general resolution that gives the Secretary General the power to assemble experts and investigate a possible allegation. If it is not done that way, the only better way is to have a standing inspector and you can't have a standing inspector to do challenge inspections that doesn't do anything else. They would soon lose their expertise because they are going to happen once in 10 years, if ever. Therefore, for that reason alone you have to have what Amy called routine, but which is really a dirty word in negotiations. Never call biological weapons inspections routine. They are random inspections but not routine. Mr. Tierney. Could you just expand a little bit on what some of the demands that the United States made were that weakened this to the point where now it is in a difficult situation? Ms. Rosenberg. Well, one of them was the trigger, the criteria for declaring defense facilities. Our allies would have liked to have had all defense facilities declared, just at least they exist. But the United States objected to that. The chairman's text therefore requires only declaration of a certain kind of defense facilities and only those that have more than 15 full-time employees. There are a lot of outputs built into the chairman's text at the insistence of the United States. I still think that the chairman's text concentrates on the most important sites, but it leaves out others that I think should be declared, and I don't see any way in which that is going to happen in the foreseeable future. Mr. Tierney. Are there others? Ms. Rosenberg. There are other aspects, too. Our allies the British, who have been the prime movers here as friends of the Chair on compliance measures, have wanted a declaration of production facilities. The United States was pretty much going along with that until just the last couple of months in which we pulled our support of that. And that is what has left vaccine facilities hanging out there. As Dr. Woollett pointed out, they are being singled out. We would agree with PhRMS that it would be much better to have to require declaration of all the production facilities, including vaccine, without singling them out as some special case and of course have this kind of declaration be a broad but shallow declaration which at least covers all the kinds of facilities without delving too deeply into their possibly confidential information. We would support that. But the question is what about other parties. The chairman has tried to make a compromise text that he can sell to everyone. There is the problem. Mr. Tierney. Thank you. Dr. Woollett, is this the type of a protocol that we should enter into now and then look for a second round of negotiations? Ms. Woollett. No, I don't believe it is. I think there is an undue focus on capability and we shouldn't question at all the vast majority of the worldwide capability in pharmaceutical and biotechnology is in the United States. And we don't believe that legitimate capability should be put on trial, particularly when we are having discussions along the lines of the experiences in Iraq. We knew they were up to something. Our facilities are undoubtedly the most capable in the world. If someone was going to accuse us of being up to something, there is no way we can overcome the lack of a presumption of innocence and prove to somebody so inclined that we weren't up to something. And I think this is why we are adverse to any form of nonchallenge inspection. We don't know what we have got to show in order to be off the hook. We can show what we do, but apparently that is not enough if somebody thinks there is something wrong in what they see in our facility, and this is the quandary we face. How do we avoid the false positives of any such inspection, and how do we avoid them slipping in some allegation that compromises that facility's ability to make life-saving medicines and those patients' confidence in those medicines that they are taking to keep them alive? Mr. Tierney. Colonel, do you want to make a comment on this? Colonel Kadlec. Sir, I have to put myself in the camp that believes it is better to get it right than something that is not right and basically may in the long term undermine what the original treaty was trying to do. I mentioned earlier that it was by no accident that the original drafters of convention could not put together verification measures, not because they did not want to but because it's hard. I am suggesting it is not any easier today. And clearly Dr. Rosenberg pointed out that there are certain exemptions and it clearly puts out the possibility that the proliferator would have a road map to, if you will, circumvent the measure of a protocol to pursue a biological weapons program. The other thing I would like to point out, and it gets back to the routine side of the house, which is we have a very capable military today and we don't go to war every day. We don't have routine wars, thank God. It would seem odd to me to say that we have to have routine inspections to maintain the proficiency of the inspectors. It seems like exercises could be done to maintain their proficiency, particularly in the realm of challenge inspections where it really does require a very expert cadre of people to look at it, look at a circumstance. So I would kind of suggest that routine again because of--to have routine inspections just because we need to train inspectors doesn't make sense, particularly as it was pointed out earlier that their likelihood of detecting or even deterring someone's prohibited activities is probably very low. The last point I would like to make and, again to capture something mentioned earlier, it goes back to--I think Dr. Smithson mentioned that you know it when you see it when you walk into a facility. I have had that experience on several occasions, certainly at Al Hakam in Iraq, and a couple of other places there. But one of the ones where I had a similar one was a large production facility that had an earthen covered bunker, that had high security, that had an explosive handling facility, that had within its culture collection pathogens of concern and also had special handling of waste, all what I would call certainly indicators of suspicious activity. But that facility wasn't in Iraq. It wasn't in Russia. It happened to be in Michigan. And clearly from my experience on the ground, there is a pretext probability here. I always kind of joke around with the idea that people are not ghost chasers because they don't believe in ghosts. It is because they believe in them. Certainly in these dual use facilities you can find yourself in a situation because of in this case where historically the production facility occupied an area that was formerly a state police facility and had all these unusual features about it, just because that is what was made available to them back in the 1950's. So I am cautious to sign up to the camp that says, well, we can tell it completely and it clearly gets back to this issue of intent that is extremely difficult. And I would like to maybe comment on a comment that Dr. Zelicoff made, which suggests that national technical means may be the way at this problem. I would suggest it is probably human intelligence because you do hope, as the chairman has said, a whistleblower or maybe an informer inside can provide you that kind of information that gives you the probability that facility or activity is certainly doing something nefarious. Mr. Tierney. Isn't that more likely to happen if you have some sort of regularized inspections as opposed to just challenge inspections? Colonel Kadlec. Well, sir, and again I will not use the Iraqi experience but certainly my experience in the department trial visits I participated in, that the facilities that we went to did an inordinate amount of preparation, both physical and, if you will, personnel preparation. So I doubt, and this was just for a routine visit, this was not for a challenge scenario. This was at a facility that was doing all legitimate work. So I can't help but believe that if a proliferator has a facility that would come up for a routine inspection, that they would probably go through a similar preparation phase that would probably involve more than just simple preparation, but active denial and deception methods that I think would if not fluster, confuse even the most experienced inspector. Mr. Tierney. On the whistleblower aspect of it, a whistleblower is going to need an opportunity to talk to somebody that they are not going to necessarily get if it is just on a challenge basis, but if it was on a periodic inspection basis then the opportunity that otherwise wouldn't exist it would be there. Colonel Kadlec. Well, that would be his first and last time to blow that whistle. I can guarantee you, as experienced in Iraq in the cases where an individual or others have kind of raised their hand and said something is wrong there, they haven't been seen again. Mr. Tierney. I think I understand pretty much what the issues are on that, but I would like to give Dr. Rosenberg a last crack at this to respond to anything you might have heard that you think you can enlighten us on. Ms. Rosenberg. On that question of whistleblowers, actually you don't have to have a whistleblower. In a random visit there will be interviewing of various workers in a facility, and one of the important--in fact a very important tool used by UNSCOM in Iraq was interviews in which they were able to pick up inconsistencies between things that different people said. This is the kind of thing you don't get a chance to do unless you have some kind of random type visit. What else can I say? Mr. Tierney. What do you say about the false positive argument? I get the feeling that you might be inclined--and correct me if I'm putting words in your mouth--you might be inclined to say go with what we have here and then if we can improve it, improve it later. Do you see harm coming from what is being proposed now and as part of that harm this concept that it might be a false positive? Ms. Rosenberg. I think when you get 143 countries together to set up a regime that they are all going to be subject to the chances of its being dangerous for any of them are vanishingly small. There are going to be false positives that will end up as accusations for some country, maybe the Netherlands let's say, is just not a credible argument. The problem is to have tight enough measures to get anything at all, when you are trying to get a consensus agreement on a treaty with all of these countries involved. So I think it is a red herring, the false positive. Mr. Tierney. You think that the document, at least as I understand it to be at this point in time, does not create that kind of a concern? Ms. Rosenberg. It has very strong restrictions on when you can actually go in to do a challenge. There has to be a vote by the executive council and the most--the easiest vote is a 50 percent vote of those present and voting saying that the inspection can take place. That would be for any facility inspection would have to go through that. My group has done a study on looking at past votes in the Security Council and the General Assembly and so on and what the different blocs would do and we determined that a 50 percent vote of this type would essentially never end up with any challenge inspection in the United States. It is impossible given the allies that we have. So it is--we opted for that as the best possible formula because it will allow inspections in the places that we might be concerned about but will not subject our industry or others to inspections that are really not meaningful or don't have a basis that's significant. Mr. Tierney. Thank you. I was intending to give you last word, but at the expense of Mr. Zelicoff not passing the cardiogram he was talking about earlier, I would let him to speak up. Mr. Zelicoff. I did pass the poly--the cardiogram. Did you, sir, is the question. Dr. Rosenberg can assert whatever she wishes, of course, but the science does not support her. In her last statement she slipped from talking about routine inspections into challenge inspections and the issue about false positives is not with regard to challenge inspections. In fact our national trial experience shows that with the properly phrased challenge inspection the probability of a false positive is routinely small. It is rather during routine inspections that false positives are a problem, and indeed in all of the U.S. national trial inspections a false positive was generated, which is to say two things: The team was either unable to convince itself that no illicit activity was taking place or if there were perfectly legitimate activities taking place the inconsistencies that normally occur in interviewing people who work at any site raise ambiguities. So it was interesting in the lessons learned in the U.S. national trial inspection experience, which I would be happy to submit for the record, what we learned from the people at each of these facilities, and these were disparate facilities, separated both in time and space, had nothing to do with each other. What we learned from each of the facilities was were a routine inspection to take place under the Biological Weapons Convention, they would send their staff members home and they would have a rehearsed set of statements to make delivered by one or at most a few administrators to avoid the ambiguities that took place, and that would be a perfectly legitimate response on the part of the facility. So in the routine inspections, as distinct from challenge inspections, the probability of a false positive, while Dr. Rosenberg may assert it is a red herring, in our national trial experience was almost a certainty. Mr. Tierney. Do you want to leave it at that, Doctor? Ms. Rosenberg. No, I won't leave it at that because I suspect that he didn't carry out his little trial according to the rules in the chairman's text at present, which gives all access to the discretion of the host government during a visit and prohibits the inspectors even from mentioning whether or not they were turned down for requested access in a visit. So there is hardly any way that I can imagine that any false allegations could come out of such a visit. Mr. Tierney. Well, thank you all very, very much. Mr. Shays. We will get the responses to this. This disagreement among panelist keeps us awake, so I thank you. I would like to ask unanimous consent that the following article from the Chemical Weapons Convention Bulletin, Issue No. 39, March 1998, provided by Professor Matthew Meselson, co- director of the Harvard-Sussex Program on Chemical and Biological Weapons, Armament and Arms Limitation, be included in the record. And this is at the request of the minority. I think we had asked him and he couldn't make it. So we will do that without objection. I ask further unanimous consent to include in the record a letter to the subcommittee received from the Centers of Disease Control on the subject of global disease surveillance and the BWC. Thanks. [The information referred to follows:] [GRAPHIC] [TIFF OMITTED] T0137.052 [GRAPHIC] [TIFF OMITTED] T0137.053 [GRAPHIC] [TIFF OMITTED] T0137.054 Mr. Shays. Did you want to make a comment? We are going to have some disagreement and I just want to make clear what the disagreement is, not that we will solve the disagreement. Mr. Zelicoff. I simply want to state our little trial inspections, as Dr. Rosenberg pejoratively referred to them---- Mr. Shays. You're getting kind of uppity. You've got to loosen up here. Mr. Zelicoff. I get uppity when the truth of science is demeaned. Mr. Shays. I know, but then she gets uppity and I get uppity and we all get uppity. Mr. Zelicoff. Well, science is what science is and in the case of our little trial inspections, they occurred over 5 days involving 30 inspectors as well as dozens of people at facilities, and I think it discounts the efforts of all of the interagency participants to characterize them as little, insignificant. These are by far the most extensive trial inspections that have ever been done. Thank you. Mr. Shays. Thank you. I would like to know what is the extent of the disease monitoring vision under the Chairman's Text. Anybody want to jump in? Ms. Rosenberg. Yes, can I say something about that? That section of the Chairman's Text comes directly from the rolling text and it is totally unbracketed; that is to say, it has been totally agreed upon by the negotiators. Mr. Shays. Define rolling text. Ms. Rosenberg. It is the draft text which keeps getting updated. So at some point the draft text was taken which the chairman--and he tried to resolve all of the unresolved parts of it, but he didn't have to do anything with that section because it was already fully agreed. And the whole section on cooperative scientific and technological activities is focused on infectious activities, on surveillance, diagnosis, recognition, control, prophylaxis, and so on of infectious diseases. It sort of repeats itself over and over about supporting and promoting all of these activities. And the interesting thing is that not only does it say that countries should promote, that the parties of the treaty should promote these activities, but they have to declare annually what they have done to promote them, and there will be a cooperation committee that will read these annual declarations and be empowered to make comments or suggestions. Mr. Shays. I need a translation. The bottom line is, is there extensive monitoring in surveillance in the rolling text or are we basically ignoring this issue? And I open that up to you and then to others. Ms. Rosenberg. Well, the first point I think I should make is to clarify, the treaty itself is not proposing to monitor diseases and that no treaty should try to do that because infectious disease---- Mr. Shays. Am I mixing the word ``monitor'' and ``surveillance''? Ms. Rosenberg. No, I don't mean to make that distinction. I am saying it shouldn't be done under an arms treaty. I am saying it is a public health issue. If you try to carry out a public health measure under an arms treaty you will not find cooperation from all the groups and governments that you need it from. Mr. Shays. Let me respond to that. Whether or not you find cooperation, the issue is, is that necessary and helpful to have a good treaty? Ms. Rosenberg. It is very important and that is why the treaty has this section which calls upon its parties to do something on these problems and to report on what they have done. But the activities will not be carried out directly under the treaty organization, but will be left to the parties to work with the international organizations outside the treaty, but to meet the ends that are specified under the treaty, and I think everybody in the field recognizes that this is the only way to handle this if you want to get public health cooperation. That is why the World Health Organization and others have gotten together to make a proposal about how to carry out those goals that are specified in the treaty, and the parties who are negotiating have found--have welcomed this---- Mr. Shays. Are you making an assumption that others would agree with? And then am I hearing you correctly? Are you saying that to make it part of the treaty means that information of health statistics will be less readily available? Ms. Rosenberg. Oh, absolutely. The World Health Organization is always willing to make information like that available. Mr. Shays. No. Listen to my question. What I was hearing you say, and I want to just make sure I heard you properly, was that the reason health information, health surveillance is not part of a treaty is that it might distort the type of information you get---- Ms. Rosenberg. Yes. Mr. Shays [continuing]. On health statistics, and so I hear you saying health statistics. You don't want to bring it into a treaty because you want accurate health statistics. Are you saying that? Ms. Rosenberg. Right. Mr. Shays. Are you saying that? Ms. Rosenberg. I am saying that. Because you have to remember that when there is a serious outbreak in a country, it cuts off tourism, trade. India had a big problem when it had the plague break out a few years ago. It lost--millions of dollars in economic loss. So countries are not--especially if it might suggest that they perhaps violated an arms treaty. Perhaps there is an epidemic that somebody might think was due to a biological weapon. Mr. Shays. But, Doctor, what you are reinforcing in my own bias, and I admit it's a bias, there are all these reasons why we can't write a treaty that will really do the job. That's kind of where I am coming from. And I didn't start out that way. And you're making an argument that you can't--if you really want a treaty that works, it would strike me--and I realize, you know, and I acknowledge, you know, that something is out of the barn, but, still, that is going to be one basis for knowing if we have got a gigantic problem. You know, we see a distortion in health in a certain area, and we try to assess it, and we come to some conclusions. It's natural or not natural. But we want that information. Let me ask you this. First, let me let others comment to what you said, and then I'll ask the next question. Yes, Dr. Woollett. Ms. Woollett. It's an interesting parallel to transparency. We want people to be transparent. And what I'm noticing in what you've said is de facto is part of an arms control treaty, you're dissuading them, because it is in a context that has a certain supposition to it. And I think that's where the U.S. pharmaceutical biotech industry has a problem, because routine inspections become part of us being somehow checked up on for what we shouldn't be doing, rather than us affirmatively showing what we are doing, which is the true meaning of transparency. So there is actually a parallel in the surveillance side. The disease surveillance indeed should be done. We are not adverse to the world knowing what we do, but in the context of arms control, there is a context that can be very difficult to overcome. Mr. Shays. Any other comment, and then I'll---- Ms. Rosenberg. So the advantage of the protocol is that it requires this to be done, but it doesn't actually do it. It allows countries to do it outside and then report on what they've done. That's why an organization like the World Health Organization is essential to carry out something like this, because it's the only health organization that every country feels they have some part in, they are members of and they can trust it to have their interests at heart. Mr. Shays. Dr. Woollett, do you want to make--anybody maybe a comment? Yes. Colonel Kadlec. Sir, I would like to, because it kind of gets back to maybe a point I made earlier but also I think is consistent with the theme here with regard to this protocol, that some of the more significant measures to strengthen, if you will, our ability to either detect or respond to these events, a possible event of use or even development, are going to exist outside the protocol and that they deal with global disease monitoring that is outside, if you will, the text of the protocol but certainly a very important supplement part, if not a foundation piece, to build a protocol on. And the same thing with intelligence. I mean, that's, again, one of these kind of just odd kind of situations. And, again, it runs counter to maybe some of the other experiences in some of the more conventional elements of arms control to date that you do look for more ancillary, outside the formal text kind of capabilities to help you pursue nonproliferation. Mr. Shays. That would argue, though, for not having to make a challenge, because they're not part of the protocol, so you couldn't count it as a challenge. That would argue for just being able to do it at will based on all of this ancillary information that you get. In a sense, it's a challenge, but you can't use it as a challenge. Am I speaking in tongues here? Colonel Kadlec. Well, no, sir. I think the point I would like to make is that outside information is what helps you go to a challenge scenario. Mr. Shays. I know, but it's--we're hearing one point, is that you don't need a challenge, and you shouldn't operate based on a challenge. And the other argument is there should be probable cause. Now, if it's not a part of the treaty--let's just deal with this issue of probable cause. If it's not part of the treaty, this ancillary information, could you use it as a probable cause? And it would strike me you can't, because it's not part of the treaty process. And maybe that's an assumption I'm making that's incorrect. Colonel Kadlec. I would suggest otherwise. Ms. Woollett. Yeah. My understanding is that any evidence that you have that you're willing to declare is a basis for the due process, a bona fide allegation you can indeed use. Now, of course, in declaring it, there may be other concomitant liabilities to where you got it from, but the basis of knowing that there is a reason to go for a challenge, putting the evidence on the table and going ahead with the challenge, you're not limited at all to where you got the information from. Mr. Shays. You raised the question of capability and--and versus intent. Tell me, the United States potentially has what world's capability? Is it 40 percent, 50? Ms. Woollett. It's into the 90's, depending on where you do the cutoff in terms of sophistication. But of the most--I mean, for instance, if we look at pharmaceutical R&D anticipated for this year by our companies alone, something like $30 billion is the total expense, of which the high 20's are in the United States. The vast majority of the most sophisticated capability unquestionably is in this country. Mr. Shays. With the gross domestic product of Europe being larger than the United States, I mean, the whole union, you're saying that our capability would dwarf Europe's? Ms. Woollett. In terms of R&D and where the pharmaceutical and biotechnological industries are doing their investments. Now, the three principal markets are Europe, United States, and Japan. Mr. Shays. OK. But then let me--so should--is R&D more important than production in terms of---- Ms. Woollett. Well, it depends where the cutoff comes. R&D is critically important in terms of confidential business information. That's your future products. Production is the high volume end, if that's where you do the cutoff in terms of the largest amount of---- Mr. Shays. OK. Let's just do production. Is production 50/ 50? I mean---- Ms. Woollett. I would have to double-check. It's still the majority is the United States, but---- Mr. Shays. But with the rest of the world, then, we still are 50 percent plus? Ms. Woollett. I would say that Europe, United States, and Japan have the vast majority. Mr. Shays. Take--so is Europe equal to the United States? And the reason is---- Ms. Woollett. Not equal, but it's going to be high, too. It would be targeted, but--certainly on terms of vaccine manufacturer, there's four principal companies, two in the United States, one in France and one in Belgium. Mr. Shays. Dr. Rosenberg, my visits, obviously, have been guided by the previous administration, but either administration--so I've met with some of our allies, and I have not heard the--and I'm sure it exists. So it's--the point you made about our allies' feeling that we've been dragging our feet in saying we're weakening the protocol and then we criticize it for being so weak, I know there's some who feel that way, but it's not your testimony that all our allies feel that way? I mean, there is---- Ms. Rosenberg. Oh, yes. I can testify that they all do. Mr. Shays. OK. Ms. Rosenberg. I---- Mr. Shays. You leave no one out? Australia you put in there? Ms. Rosenberg. I would--oh, no. They are definitely in there. Yes. Australia, Canada, New Zealand, all of Europe, the EUs, the strongest group. Mr. Shays. And it would be your testimony before this committee that they feel the United States has consistently over the past few years weakened the protocol? Ms. Rosenberg. Yes. You know, worse than U.S. demands for specific weakening points is the fact that the United States has not stood together with the rest of the western group, which means that the western group was perceived to be split by other countries such as China. We now stand with China, Libya, Iran, Cuba and Pakistan. Those are the five dissidents with the United States. Mr. Shays. Yeah, but for different reasons. Ms. Rosenberg. Well, no, not for different reasons. For objecting to the protocol. Pretty much for the same reasons. And the problem is that if the western group had been together they could have pushed through certain points that would have made a stronger protocol, but because everyone saw that the United States was not with them, it was not possible to do that and other points of view carried the day in many cases. So the United States has weakened the protocol in a number of different ways. Mr. Shays. If anyone wants to jump in, I just want to ask a few more questions. Is there any--yes? Mr. Zelicoff. I was a member of the U.S. delegation from 1992 through 1999. I sat in on every western group meeting, and there was not quite an unanimity of opinion, sans the United States, that we were the treaty busters. The Japanese have violent disagreements with the rest of the western group as well, and I think it goes largely to where pharmaceutical capabilities are located as well as advanced R&D. Mr. Tierney. Dr. Rosenberg, where would you say most objection comes from, the commercial end or the national security end of things? Ms. Rosenberg. In the United States? Mr. Tierney. Yes, ma'am. Ms. Rosenberg. National security, although they love to hide behind industry. We know that--I mean, the classical case was the negotiation of the Chemical Weapons Convention, where the industry was very pro-treaty, and the United States was still blaming some of its positions on industry, when industry was saying, oh, no, we disagree with you. We want these measures. They've continued to do that with the pharmaceutical industry, and I've been very happy whenever there's been any resistance on the part of industry. But I don't believe that's where the real problem lies. Mr. Tierney. Thank you. Mr. Shays. Dr. Rosenberg, you talked about our allies and where they stand. Who represents the greatest threat in terms of the production and use of biological agents? Ms. Rosenberg. Which countries? None of our allies. Mr. Shays. None of our allies. Correct. So who are they? Ms. Rosenberg. Well, you know, there's the usual 10 or 12 that are always cited. Mr. Shays. And why don't you cite them for me. Who---- Ms. Rosenberg. Which of the countries are? Mr. Shays. Yeah. Ms. Rosenberg. North Korea, Syria, China, Israel, maybe Libya. I'm not sure whether Libya is in there right now. Well, India and Pakistan have occasionally been mentioned. I think they're pretty uncertain. It's the usual suspects, in other words. Mr. Shays. We've left out one or two. Ms. Rosenberg. Right. Mr. Shays. But the bottom line to it is that they are all-- the irony is that I don't think you fear the United States using---- Ms. Rosenberg. Absolutely not. Mr. Shays [continuing]. Biological--and I didn't mean it to sound facetious. You don't. The irony is that we're negotiating with--in the treaty with people that we know for a fact produce it, and some have used it, and it's wild to be in an environment where I hear them speak and--frankly, very sanctimoniously--and yet we know that they're, as we speak, are involved in the production of biological agents and believe they would use them. So what I wrestle with, knowing what I know as a Member of Congress--and there is more that we could put on the table that we can't. I mean, there is more that we know that we could put on the table, but we can't--we are dealing with people who we know have the capability and the interest and potentially the inclination to use biological agents. Those are the groups that I'm most concerned with, and yet I'm wondering if we have the capability with a treaty to prevent them from debating it, you know, research, doing the production and so on, because I side on the equation that says it's not the gigantic plant, but it is--you could do it in trucks. You can move trucks. You can do it in tents. So get me beyond that. If I can get beyond that, then I would be a lot more receptive to your eagerness to see this treaty move forward. Ms. Rosenberg. Well, first of all, it's interesting that many of these countries that are suspected are involved in the negotiations, and I think that's a big advantage, because they obviously don't want to admit their interest in biological weapons---- Mr. Shays. Could I---- Ms. Rosenberg [continuing]. And they therefore are not going to block the treaty because---- Mr. Shays. But that to me is the hypocrisy of it all. Ms. Rosenberg. Hypocrisy, who cares, as long as we are able to get onsite or, you know, as long as we're---- Mr. Shays. What good does it do to get onsite if they move the truck, if they move the tents, if they shut down the--see, because my--this is sincerely asked. It's right--and it's maybe my ignorance, but I can see the capability--if you were trying to put out incredible amounts of this, you would build a big facility, and it would have a signature to it, and you would all know. But a country that simply has more interest in terrorist use, in production over years but low output but over time it adds up, they have the capability, and the treaty in my judgment would be a joke---- Ms. Rosenberg. Well, you don't---- Mr. Shays [continuing]. For preventing those. Ms. Rosenberg. Excuse me. You don't add up biological weapons, because they don't--most of them don't have that long a shelf life. Mr. Shays. That's true. Ms. Rosenberg. And to do any---- Mr. Shays. Other than something like anthrax. Ms. Rosenberg. Right. Mr. Shays. Well, but--no. With all due respect, we---- Ms. Rosenberg. Yes. Mr. Shays [continuing]. Are having all our military have vaccines on that, so it's not a minimal concern. Anthrax seems to be the one that most have the biggest concern about. But, at any rate, your point is, some are, some aren't---- Ms. Rosenberg. Well, my point is that I think there has been a lot of hype about the terrorist possibilities of bathtub production and that kind of thing. I think that producing--that developing and producing biological weapons is not an easy task. You might be able to produce it in a boxcar, but you have to have tested it somewhere before. You've got to have a lot of knowledge about it. You have to know how to deliver it. You have to know that it's going to stay viable as an aerosol. There is an awful lot of information you need. It's not simple. And, you know, Russia, which was a problem--I mean, the Soviet Union, had tens--dozens of tons of smallpox and other agents stockpiled. Those are the problems that we have--we want to know about, and we didn't. So---- Mr. Shays. Yeah. I---- Ms. Rosenberg [continuing]. You know, the boxcar that hasn't bothered to do testing somewhere, that hasn't gone through a whole process of development, you know, is--it may be a little--has a little bit of danger involved, but it's minor compared to the big time. Mr. Shays. OK. I will--I see some hands going up. Mr. Gilman is here, and I would call on him if he would like to be recognized. But I do want to say to you, it may be only a few years that I've been involved, this committee and me in particular, in the whole issue of this protocol, but it has been years and years that I've been involved in the issue of terrorism. And I can't emphasize enough my concern. I believe there will be a biological, chemical or nuclear attack on the United States. I have no reluctance in saying it. It's not a question of if it will happen. It's a question of when and where and, obviously, the magnitude. And, you know, this kind of treaty, in my judgment, will not stop any of the kind of concern that I particularly have. And--but it's not to say we shouldn't be trying to make a good treaty. I just have not yet in my own mind seen how I would--if I were President of the United States, whether it was Bill Clinton or Mr. Bush--since I said Bill Clinton, I should say George Bush--President Clinton, President Bush--I don't know what I would be directing my people. Let me just let you all make some comments, and we're ready to kind of draw it to a conclusion here. But, yes? Colonel Kadlec. Sir, I just wanted to capture the point that you made earlier, that it is one of the paradoxes of a potential protocol to a--a protocol to the BWC that if you comply with the protocol, it somehow confers legitimacy to you potentially as a proliferator and, again, may obviate some of the other things that we are using today, some of the other tools that we have in our toolbox in terms of multilateral export controls that help us put a cap on this or delay it. The second issue is the issue of whether or not there has been, as Dr. Rosenberg put out, a reluctance on the basis of national security or the industry--the pharmaceutical industry and their resistance to a protocol. And I'd just point out that it's very hard to divide the two today because of the role of economics in our national security, but more significantly to the point you just made about when you look at the role of terrorism and domestic response, how much we rely upon the pharmaceutical industry to provide those products that we need to use to either defend or treat our populace, should something happen. And I just throw that word of caution out. Mr. Shays. Any other comment? Mr. Zelicoff. We have a very bad problem with biological weapons, and it's certainly possible to take the biological weapons proliferation problem and make it worse. Dr. Rosenberg is correct when she states that it's necessary to test biological materials to see if they will work as weapons, but that depends on the scenario. But, more to the point, that testing has already been done. Stockpiling is no longer necessary, because the parameters for growing materials into pound or ton quantities are also very well known and can take place in a matter of a few days or a few weeks. And then, finally, whenever you think you've got your hands around the biological weapons problem and think that things like onsite inspections, routine visits are going to solve the problem, always consider the case of smallpox. Here is an agent that spreads perfectly well from person to person. So all of the criteria that Dr. Rosenberg laid out earlier, such as large quantities, aerosolization, need to know whether it infects, none of those things obtain in the case of smallpox. Were a country to desire to undertake a terrorist event with biological weapons, smallpox is arguably the way that they would do it, and the facility necessary to produce it would be an Erlenmeyer flask that looks something like this or certainly about that size. And you can create enough material to infect a dozen or two dozen people, and then they will do the chain of dispersal for you. And so this is what the American Federation of Scientists is putting out. The technologies of the 1950's that required large fermentation vats have been supplanted by the modern tools of biotechnology and a recognition that we have infectious agents that undermine all of the tenets that are put down in the treaty as signatures or markers of something adverse taking place. None of that would obtain in the real world. Thank you. Mr. Shays. Thank you. Yes, Dr. Woollett. Ms. Woollett. I would just like to comment that if there is the prevailing assumption, which seems to be fairly broadly held, that we have signatories to the existing Biological Weapons Convention who don't comply with it, are we actually expecting them to comply with the protocol either? What are the checks? Are there any checks? It seems to be a real leap of faith that if they don't play cricket on one treaty they certainly will on another. Thank you. Mr. Shays. I'm ready to close. I know, Mr. Gilman, that you have a deep interest in this issue, but you're kind of coming at the conclusion. I don't know if you want to say hello or good-bye or hello and ask your question. Mr. Gilman. Well, Mr. Chairman, I want to thank you for conducting what I consider to be a very important issue as we address all aspects of terrorism. I just would like to question the panelists. Is there any central authority in our government that is reviewing the possibility of biological and chemical weapons? Who is in charge of this in our government? Is there any--we found in exploring terrorism that we had a great deal of--a proliferation of responsibilities, and there was really no central--good central issue, and the chairman that had been conducting hearings, I think we found some 40 different agencies that had responsibilities. What about the biological and chemical weapons' situation? Is there any central authority? I'm asking the entire panelists. Mr. Shays. Four are smiling. One is putting his hand over his nose. And three are smiling, one is smirking. Which one do you want to pick? Mr. Gilman. I'll go right down the line, starting here with our Mr.---- Mr. Shays. Let me just say it is an interesting question for you all outside of--directly outside of government now to tell us who you think would be responding. Mr. Gilman. Mr. Zelicoff, do you want to respond? Mr. Zelicoff. Is your question with regard to who is developing policy or who responds in the case of an attack? Mr. Gilman. Who is in charge? Mr. Zelicoff. I am not the person to answer that question. Mr. Gilman. Implementation, is there anyone in our government in charge of this? Mr. Zelicoff. The last time I looked, there was a chart that had a whole bunch of agencies connected with various strings of higher--but I don't know who is in charge now. Mr. Gilman. Ms. Smithson. Ms. Smithson. Volunteering has its risks. I'm not sure I'm volunteering here, but it's fairly new in the Bush administration, but I think it's accurate and traditional to say that the National Security Council would be in charge of policymaking here, Bob Joseph and Rich Falkenrath being the two individuals that have this portfolio principally at the NSC. The Ambassador to the U.S. negotiations is Don Mahley. He works out of the State Department. The intelligence community, the Department of Defense and the Commerce Department also have very important roles to play in policy formulation here, as does the Department of Energy, because they have a number of assets and have had members on our delegation for quite some time. So, in a certain sense, it's somewhat similar to the organization to address terrorist problems. There are a lot of agencies at the table here. Mr. Gilman. But would you say it would be important to have some central authority to produce overview of all of these problems? Ms. Smithson. I'd always advocate having central authority in our government, but find as a student and observer of our government's policymaking process that the individual who has the title for having central authority sometimes doesn't necessarily find himself or herself able to fulfill that role, because everybody is grappling for power. Mr. Gilman. Thank you. Dr. Rosenberg. Ms. Rosenberg. Well, this is not an area that I've specialized in, but I do read some of the literature on it, and I observe that all the experts outside of government have complained rather bitterly that the program is much too diffuse, there is no central authority, and there is a desperate need to do something about that if we are going to have a meaningful response to bio or chemical terrorism. Mr. Gilman. Thank you. Dr. Woollett. Ms. Woollett. I think it has been fairly conspicuous that there is no central authority. We within the industry have worked with whomever is available whenever they are available, but one very apparent deficit is those agencies with the most technical expertise are the very few that are absent. For us, that would be the U.S. Food and Drug Administration and also those players at USDA that have expertise in the infectious diseases. Even CDC hasn't been actually very conspicuous at all. So it's been sort of policy devoid of the science and the technical, which ultimately will be the limitations on this protocol. Thank you. Mr. Gilman. Colonel Kadlec. Colonel Kadlec. Sir, I don't think I have much more to add than what has been offered here today. I think clearly that it seems like the group senses that there doesn't seem to be a focal point for this issue. Mr. Gilman. And, Mr. Chairman, just one other question. If we were to have some administration of people come before us on this issue, what questions should we ask the administration witnesses about the U.S. position on the BWC protocol when they do appear before our subcommittee? Can anybody---- Mr. Shays. One or two choices. What would be the questions we should ask? Mr. Gilman. We'll start again right down the line. Mr. Zelicoff. Mr. Zelicoff. If you had just one or two questions, I think the questions that I would ask are, should we move ahead with the current protocol as it is, or should we try to negotiate something that might be either more effective or more responsive to the needs of the United States? And, second, I would specifically ask whether or not the administration has a position on strengthening, either directly or indirectly, the limited capability worldwide for disease monitoring. Mr. Gilman. Dr. Smithson. Thank you, Mr. Zelicoff. Ms. Smithson. Actually, the questions you posed to this panel and the other witnesses I think were quite good ones. Perhaps I could add to that list. Given the widespread expectation that the Bush administration will reject the chairman's texts, what steps forward do they have to--in mind to keep this process going guard constructively? And, second to that list, how will they turn the sour relationship with industry into a constructive one that helps create workable, meaningful monitoring procedures for this treaty similar to the relationship that existed between the U.S. Government and the chemical industry for working on the Chemical Weapons Convention? Mr. Gilman. Thank you, Dr. Smithson. Dr. Rosenberg. Ms. Rosenberg. In Geneva, the negotiations--the U.S. delegation has talked rather freely about its dislike of the present negotiating mandate and how they prefer a different one. I would find out what kind of a mandate exactly they would like to have and what kind of a treaty protocol might come out of such a mandate and how would they--how do they propose to keep our allies involved and participating in such an endeavor. Mr. Gilman. Thank you, Dr. Rosenberg. Dr. Woollett. Ms. Woollett. I think something along the lines of how will this protocol help global security and then in particular, commensurate with its costs with the United States, it will be undoubtedly focused on the United States. If it's not this protocol, what are the options they see for proceeding with a time line? I think a time line is critical. Thank you. Mr. Gilman. Thank you, Dr. Woollett. Colonel Kadlec. Colonel Kadlec. Sir, I would just offer one, and that is specifically one that is I think touched on by your subcommittee today, and that is, has the deterrence value of a protocol--of this particular protocol--this particular draft protocol. Mr. Gilman. Thank you. Thank you, Mr. Chairman. I want to thank our panelists. Mr. Shays. I want to thank the gentleman for coming, because I'm happy he asked the questions he did. Before we actually hit the gavel, is there any closing comment that any of you would like to make? We'd be happy to have that. Yes. Ms. Rosenberg. I just would like to encourage you to continue to pursue the question of surveillance for infectious diseases, although we didn't really get into it today. I think it's a terribly important issue from the point of view of biological weapons and public health in general. Mr. Shays. The two times I've gone to Geneva I've met with the World Health Organization, because I happen to agree with you. I fear the spread of disease in a way that I didn't a few years ago, both natural and man-made. You all were five excellent witnesses. This was a fascinating panel, and I liked a bit of disagreement that you had, and I learned from all of you. So--and I think the rest of the committee did, and we will be transcribing this in 3 days, and you will actually be looking at the text of it. It will help us with our next hearing. So thank you so much. This hearing is adjourned. [Note.--``Procedures for Investigating Suspicious Outbreaks of Infectious Disease in a Noncooperative Environment,'' by Jonathan B. Tucker may be found in subcommittee files.] [Whereupon, at 4:30 p.m., the subcommittee was adjourned.]