Copyright 2001 Federal News Service, Inc.  
Federal News Service
November 6, 2001, Tuesday
LENGTH: 9485 words

HEADLINE: PANEL II OF A HEARING OF THE TECHNOLOGY, TERRORISM AND GOVERNMENT INFORMATION SUBCOMMITTEE OF THE SENATE JUDICIARY COMMITTEE
 
SUBJECT: GERMS, TOXINS, AND TERROR: THE NEW THREAT TO AMERICA
 
CHAIRED BY: SENATOR DIANNE FEINSTEIN (D-CA)
 
PANEL II LOCATION: 226 DIRKSEN SENATE OFFICE BUILDING, WASHINGTON, D.C.

WITNESSES: JOHN PARACCINI, RAND CORPORATION; MICHAEL DRAKE, CALIFORNIA TASK FORCE ON BIOTERRORISM; AND RONALD ATLAS, AMERICAN SOCIETY OF MICROBIOLOGY
 


BODY:
SEN. FEINSTEIN: Senator McConnell. I'd like to defer to you. We will now be introducing our second panel. It's my understanding that you have a very distinguished constituent that you would like to introduce.

SEN. MCCONNELL: Well, thank you, Madam Chairman. I congratulate you on holding these hearings on probably the most timely subject in America today, and take particular pleasure in being here as a member of the subcommittee to introduce a constituent of mine, Dr. Ron Atlas. Dr. Atlas is here representing the American Society for Microbiology, where he serves as the organization's incoming president and co-chair of its task force on biological weapons. The American Society for Microbiology is the single largest life science society, representing more than 40,000 scientists. As we know, microbiologists are on the front lines in our efforts to detect biological agents in the environment, and treat those who have been exposed to them.

I have had the pleasure of working with Dr. Atlas in his capacity as the dean of the University of Louisville graduate school, and the director of U of L's Center for the Deterrence of Bio-Warfare and Bio- Terrorism. With Dr. Atlas and U of L's assistance, my hometown of Louisville is at the forefront of communities developing plans to respond to biological attacks. Through the course of this year, I've worked with Dr. Atlas and U of L to secure funds for the center's initiatives in the fiscal 2002 Labor/Health and Human Services appropriations bill.

In recent weeks, Dr. Atlas has shared his expertise with the White House, the Centers for Disease Control and Prevention, and various news outlets. And I'm grateful that he's able to join us today and offer his insight to our panel and thank him for all of the leadership he has demonstrated during this trying time. We're very, very proud of him at home, and grateful that he's here today.

SEN. FEINSTEIN: Thank you very much for that introduction, Senator McConnell. And why don't you proceed, since you've had that wonderful introduction, and go ahead, and then we will introduce the remaining panelists.

DR. RONALD ATLAS: First, thank you, Senator McConnell, for that very kind introduction. And thank you, Senator Feinstein, for inviting me to testify today on behalf of the American Society for Microbiology. And that you, Senator McConnell, for your role in helping us combat terrorism. I would like to just summarize some of my comments and ask that the full testimony be added to the record.

And what I'd like to say is that this misuse or micro-organisms has shocked the more than 42,000 members of the ASM. The criminal and deliberate spread of anthrax is completely contrary to the ends of science and the principles for which ASM stands. And to minimize the risks of bio-terrorism, the ASM has consistently advocated appropriate government oversight and monitoring. ASM's view is that legislation and regulations can, should and must ensure protection of public safety, but that they should do so without encumbering legitimate scientific and medical research, or the clinical and diagnostic medicine needed for the detection and treatment of diseases. In 1999, I testified before the House that the ASM strongly supported the registration for possession of all facilities that had select agents, so that we very much support the position that you have advocated that registration is necessary. In our view, though, registration through appropriate federal regulatory mechanisms is tantamount to certification and that those regulations can and should control who has access to the agents and the bio-safety and bio-security measures that in fact need to be in place.

Concerning who should be responsible for that oversight, the ASM feels that this should be in the hands of the Centers for Disease Control and Prevention. That is the organization that understands public health, that has a relationship with the scientific community, and can best provide the necessary oversight. And we think that the CDC should have the resources to do this, and that they should specifically periodically revise the list of select agents so that we have those true bio-threat agents at the top of our list, that they should promulgate additional regulatory measures that ensure bio- safety and bio-security, and that they should notify the Department of Justice with any concerns that they may have about who is in fact possessing these agents. We think the CDC has a long history of regulatory oversight concerning bio-safety, and that their bio-safety manual outlines both bio-safety and bio-security measures that in fact should be in place. We need to recognize, though, that bio-terrorists are not going to follow the bio-safety manual. They're not likely to register, and that it really is only the bio-security and shipping aspects of those regulations that may help us identify where agents have come from.

Regarding who should be entitled to work with select agents, we support the concept of setting reasonable limits upon persons who may possess those select agents. We fully support the restrictions that preclude individuals who are disqualified from purchasing firearms from possessing select agents. We well recognize that some care needs to be exercised when we extend this, for example, to cover aliens. We support the provisions of the USA Patriot Act, which restricted possession for aliens from those countries that are designated as supporting terrorism. But we are concerned about an extension of this to all aliens -- to Canadians, to other allies who in fact join us in our fight against infectious disease. This is a global fight. Infectious disease occurs all over the world. It is a national security threat when it occurs naturally, and we have to enlist the aid of people from around the world. And in that regard, we have to ensure that we do not take actions that will form roadblocks between us and the international community in our effort to in fact combat infectious disease.

In that regard, we have some concern with the USA Patriot Act, concerning the fact that it did not provide any ability for an exemption. If the secretary of HHS and the attorney general feel that someone should work with pathogens that are on the select agent list, even if they're from one of the countries that supports terrorism, we think that the appropriate government officials should have been able to propose such an exemption. So, that is, you know, a concern of ours.

With regard to criminal penalties, we think these really have to be specific, and that they can and should be enacted in a way that does not turn all of us legitimate scientists into potential criminals, where we run away from doing the necessary work of developing diagnostics, and vaccines, and pharmaceuticals that combat infectious disease, including those that threaten us, like anthrax, in cases of bio-terrorism. So, we urge extraordinary specificity in those very clear rules of the road so we know what we're doing and we follow those rules.

In conclusion, we feel that legislative acts to enhance national security should add protection, that there are criminal acts of bio- terrorism that should be dealt with, and that we need to act in ways that improve the health of Americans and those beyond our shores with the development of new pharmaceuticals and vaccines and diagnostic capabilities that will protect the health of all Americans from both natural diseases and those that may come from criminal bio-terrorist attacks.

In closing, I want to thank you, Senator Feinstein, for holding this hearing, and allowing me to address the subcommittee. This is a very important topic.

And finally, I would just like to express the view that working together, the government, and the scientific, and medical communities can defeat the future threats of bio-terrorism.

Thank you very much.

SEN. FEINSTEIN: Thank you very much. And I certainly hope you're correct. Thank you. Next, I'd like to introduce Michael V. Drake, M.D., vice president of health affairs for the University of California Office of the President. Dr. Drake was appointed University of California system- wide vice president for health affairs in March of 2000. he oversees education and research activities at the University of California's 15 health sciences schools -- that's medicine, dentistry, nursing, pharmacy, public health, optometry, veterinary medicine, including academic medical centers, UC Davis, UC Irvine, UCLA, UC San Diego and UC San Francisco. The university is the largest single producer of trained physicians in the United States. He's a member of several scientific and scholarly societies, and we're -- and he's also the principal investigator on active grants and contracts totaling more than $11 million, and is a practicing ophthalmologist. We're delighted to have you with us, Dr. Drake.

DR. DRAKE: Thank you very much, Senator Feinstein. Madam Chair, distinguished members of the committee, I'd like to request that my written testimony be submitted for the record.

SEN. FEINSTEIN: So ordered.

DR. DRAKE: I've been asked to speak on our responses to the events of the last several weeks. In response to the unfortunate case of inhalation anthrax in Florida in early October, California Governor Gray Davis contacted the University of California and other institutions with questions regarding our state's ability to respond to such an attack. He followed this contact with an executive order establishing, under the auspices of the state's Strategic Committee on Terrorism, a series of subcommittees, including the Subcommittee on the Protection of the Public Health.

I co-chaired this committee along with Dr. Diana Bonta, director of the California Department of Health Services. The committee met on October 19th and submitted its confidential report to the governor on October 25th. The committee includes, and I quote, "representatives from the University of California, medical and health-care associations, public-health organizations and state agencies and departments."

While the specific recommendations to the governor remain confidential due to the sensitive nature of the information, I'm pleased to share with you today a general sense of the committee on several important issues related to bioterrorism.

First and foremost, our committee found that there is a great need to improve the communication between and training of personnel in the continuum of public-health services from the initial response teams to the treating physicians and nurses. This involves improving information services directed at both public-health professionals and the general public, improving coordination among local, state and federal agencies, and doing all of this in ways that will strengthen the public-health system even in the hopeful event that no further terrorist attacks occur.

Several efforts in this regard have been initiated by the CDC, and obviously the events of the past several weeks teach us that we should accelerate our efforts to make these programs fully operational and to expand their reach.

In all cases, it is crucial to make certain that our crisis management infrastructure and protocols enhance our ability to manage the ubiquitous chronic problems that affect the public's health on a daily basis. There's a common aphorism used on the wards of our teaching hospitals that states, "When you hear hoof beats, it's more likely to be a herd of horses than a stampede of zebras."

Stated differently, common diseases occur in uncommon ways more often than uncommon diseases occur. In preparing for attacks of bioterrorism, we are guarding against the uncommon, but we must not lose sight of the myriad problems that we were dealing with on September 10th. We were very engaged in issues of great importance to the health of the public on a daily basis. But those problems did not disappear on September 11th.

Our public-health system is understaffed and underfunded. Many Americans are vulnerable to disease and injury in ways that we could avoid. We should seek solutions that not only enhance our national security but that also improve the public safety. In demographically diverse states like California, it is very important to provide public information in a culturally competent manner and in multiple languages.

In addition to the public-health response, university faculty are actively pursuing solutions to problems that may affect us in the future. For example, researchers working in the field of biofiltration are investigating ways of removing highly toxic materials from the air, as well as novel detection techniques and methods for degrading toxic pollutants. Researchers in the environmental energy technical division at the Lawrence Berkeley National Laboratory are developing building management strategies to reduce occupant exposures to an unexpected release of toxic aerosol or gas.

Although much of our country's attention over the past month has been appropriately focused on bioterrorism, we remain cognizant of the possibilities of other threats as well. And two of our newly-funded state initiatives, the California Institutes for Science and Innovation, are also conducting research in ways to defend critical infrastructures such as telecommunications, the power grid, air traffic control system and financial markets.

Our research scientists are critical to this endeavor in another way. At a recent meeting hosted by the Association of Academic Medical Centers, Tara O'Toole from the Center for Civilian Biodefense Studies at Johns Hopkins observed that biology is on the precipice of losing its innocence in the 21st century the way that physics lost its innocence in the 20th century.

But unlike weapons of mass destruction arising from the realm of physics, biological weapons do not necessarily require a state- supported program. They can be developed by a few individuals with fairly modest resources. We will be increasingly dependent on the scientific community to work with law enforcement and other branches of government to develop effective measures for ensuring the public safety.

My colleagues at the University of California -- and I'm certain I speak for the faculty at other academic institutions as well -- would welcome the opportunity to work with you in developing policies that increase laboratory security without compromising laboratory research.

Our fundamental mission, of course, is education. We have added new courses for our students and our broader constituency to learn more about the potential causes, effects and repercussions of terrorism on our shores. For example, 50 new courses were added at UCLA. And at UCSF, the noon lecture series open to the public has begun a series featuring discussions of topics ranging from bioterrorism to religious intolerance.

The Association of American Medical Colleges last week announced an initiative to help educate and prepare the nation's physician workforce to respond appropriately to terrorist attacks. And one component of this project will focus on integrating bioterrorism education into the medical-school curriculum. I know that when I was in medical school in the early '70s, we learned about smallpox, and then that was removed from the curriculum because this was a disease that had been eliminated. This year it was re-added to the curriculum.

Universities take seriously their public-service responsibility to respond to threats to our health and security. This is particularly clear to us at the University of California because of our half-century of management of the national labs in Berkeley, Livermore and Los Alamos.

The marriage between academic, scientific and -- (inaudible) -- national security has been sound and mutually beneficial. And we, along with our sister institutions, stand ready to address prevention and response to attacks and natural disasters. We are actively pursuing these issues at the present time and look forward to working with you as we refine and improve our programs that address the reality of terrorism in the future.

Senator, on behalf of the University of California, we applaud your leadership in this issue and we look forward to working with you and your colleagues as you continue to work on the many difficult issues facing the nation. Thank you for your time and attention.

SEN. FEINSTEIN: Thank you very much, Dr. Drake. I'd like to say that the record will remain open till the end of the day to receive statements. And I'd like to add to that record the statement of the chairman of the committee, Senator Patrick Leahy.

I'd now like to introduce John Paraccini. Mr. Paraccini is a policy analyst at RAND. Previously he served as executive director of the Washington office of the Monterey Institute of International Studies and the Center for Non-Proliferation Studies. He's editing a volume of case studies analyzing terrorist motivations and behavioral patterns involving the use of radiological, biological and chemical weapons.

Prior to assuming duties at the Monterey institute, Mr. Paraccini was a senior associate at the Henry L. Stimson Center. He has taught at the University of Southern California and Baruch College of the City University of New York. He's had short assignments at the U.S. State Department's operations center, Bureau of Political-Military Affairs, Intelligence and Research, and (Ocean Sand?) International Environmental & Scientific Affairs. He holds an MBA from Georgetown, an MA from Johns Hopkins and a BA from Haverford College.

Welcome, Mr. Paraccini.

MR. PARACCINI: Thank you. Thank you, Madam Chair, for the privilege and the opportunity to testify on this topic. I, too, would like to request that my written statement be entered into the record.

SEN. FEINSTEIN: So ordered.

MR. PARACCINI: I'd like to focus on the recent anthrax attacks as a case study. A paradigm shift, I think, has occurred in the whole field of biological-weapons terrorism. The sophisticated quality of the material sent to Senator Daschle here at the Senate really has called into question assumptions about three possible perpetrators. Heretofore, we've not thought that states would attack us in peacetime. And indeed, the quality of the material that arrived here was of that level, state-level quality.

Heretofore, we've not thought that a state would give this type of material to a terrorist group or to an individual, and yet that is a possible perpetrator here. Heretofore, we have really not thought that a terrorist group or an individual could, by themselves, culture and develop material of the sophisticated quality that we saw here in the Senate.

So something is happening that's fundamentally different than it was before these incidents occurred. They're serious. But we should maintain some perspective on the nature of the threat. They're serious, and there has been some tragic loss of life, and indeed some exposures, but it does not compare in any way to what happened on September the 11th, in which approximately 5,000 people died in short order.

So while we're troubled by these anthrax attacks, we need to keep in perspective what did occur on September the 11th and how, in a very short period of time, terrorists turned an ordinary means of modern transportation into a fuel-laden cruise missile that destroyed major buildings both in New York and over at the Pentagon.

We've not been able to identify any link between what happened on September 11th and the anthrax attacks or between the September 11th terrorists and the Iraqi government, but there are suspicious (moments?) of connection between all three. But I think at this time -- (inaudible) -- we ought to keep our mind open to what the possibilities might be.

The historical record on the use of weapons of mass destruction for terrorism is remarkably small, given how vulnerable we are as an open society. So we have to ask ourselves, fortunately, why is that record so small? It's both small in terms of terrorist use but also in terms of nation-state use. Nation-states certainly have the ability to assemble the people and the industrial capabilities to make these types of weapons. And yet, on the battlefield, fortunately they're a comparatively small data set when they've actually been used.

But in the last 15 years, there have been some disquieting developments. There's been a change in how terrorists have operated. In contrast to the terrorists who used to strike at symbolic targets and then issue long turgid manifestos articulating their point of view, we now are in a period in which terrorists strike indiscriminately and kill lots of people and never claim credit, or at least never claim credit until they've been captured, tried and imprisoned.

So are we at a fundamental historical disjuncture? And I think that's a question we need to ask ourselves. The historical data suggests that this is comparatively rare that this happens, but indeed there's some disquieting new trends.

I think we want to also bear in mind that while we are unusually vulnerable and there are capabilities out there -- and I thought the questioning with some of the government witnesses was very revealing about some of the possibilities that are out there that we should be concerned about -- but we need to balance those concerns about possibilities with what are some of the obstacles, and indeed disincentives, for terrorists and individuals to use these type of weapons. Otherwise it would be occurring much more often than it is.

And perhaps if we examined in some detail some of the obstacles and disincentives, we can, in a broad effort, try and augment those disincentives and those obstacles to make it less likely. We're never going to eliminate the problem of terrorism. We may never eliminate the problem of proliferation. But we can certainly narrow the possibilities.

Technical and operational barriers are important, and they have heretofore made a significant difference in the nature of this threat that we've faced. We should examine those technical and operational difficulties in greater detail and try and augment them. There also are readily-available alternatives, unfortunately; that is, more terrorists have used explosives, high explosives, and killed more people than have died in all of the terrorist attacks using unconventional weapons.

So there are these alternatives that a determined terrorist will turn to as opposed to sort of going through the elaborate process of trying to develop very sophisticated heretofore thought to be just military-grade weapons. With biological agents, there is not the psychic gratification of immediate response that the bomber gets. Biological agents require delayed gratification, and there's not the immediate response. They occur over time. There may be a psychic difference here that we ought to understand as well.

Finally, the fear of retaliation is something that gives people pause, even determined killers.

Let me conclude by pointing out that in this new phase, there are some contradictory indications. One is we have seen a paradigm shift. But I think the response of Congress, the executive branch, local responders, is help ensuring that we can manage a limited biological- weapons attack. This may prove in the end that these are not as effective weapons, if indeed your design is really to kill lots of people.

But the enormous attention on these attacks is likely to stimulate interest in others. So we should proceed with great caution and great concern. I think we should re-energize our efforts to find preventive tools, to add to our tool kits, to stop the proliferation of these materials to individuals and sub-national groups, and indeed states way out in front, long before they ever come to our shores.

Finally, it's hard to maintain perspective on relative dangers in the moment of a crisis, but I think that's the challenge of leadership and that's what we need to do. And on September 11th lots of people died, and the task that we have now is to address what is a serious biological attack, but on a different scale and magnitude.

Let me conclude there and thank you once again, Madame Chair, for the opportunity to testify, and I look forward to your questions and the questions of the other senators.

SEN. FEINSTEIN: Thank you very much. I appreciate this. Thank you. I have in front of me a current CDC list of biological pathogens and toxins -- viruses, bacteria, fungi and toxins. And there are about 40 of them, and I'm just reading what they do and they are absolutely devastating.

Mr. Atlas, let me begin with you. In your estimation, how many labs in the United States currently possess or work with these select biological agents?

MR. ATLAS: I guess the answer to that is probably a few hundred, 250-plus laboratories. That's based on a survey that we did at the University of Louisville under subcontract from the Department of Energy, where we surveyed all universities in the United States, all 2,500 institutions, and came up with that sort of estimate in terms of universities, anyway, having select agents.

SEN. FEINSTEIN: And they would work with one or some of this list of 40?

MR. ATLAS: That's correct. One or some. We've gone back, Madame Chairman, and looked at anthrax in particular, and the estimate there is probably 20 to 30 laboratories having anthrax at universities; not necessarily all having virulent forms. Some could be vaccine strains. We did not differentiate b between whether it was a pathogen or not and, in fact, the CDC list, unless it's a licensed vaccine, does not differentiate between the real disease-causing forms and those that are not capable of causing disease. The only exemptions in that shipment list are for the strains of particular organisms like the bacterium that causes anthrax if it's licensed as a vaccine strain.

SEN. FEINSTEIN: What is the significance of that?

MR. ATLAS: It means that of the numbers I'm giving you, in fact, fewer labs probably have virulent strains; those strains of these agents that could cause disease or be used by bioterrorists.

SEN. FEINSTEIN: Okay. Do you believe that anyone not affiliated with a legitimate health or research institution should be able to possess his or her own personal supply of anthrax?

MR. ATLAS: Absolutely not. These agents should be restricted to legitimate facilities, and the workers there must be pursuing research or diagnostic activities that are for the public good.

SEN. FEINSTEIN: Well, I happen to strongly agree with you. Then why do universities oppose this? Why -- why is there this -- it's all sub rosa, but as soon as you begin to surface with really a strict certification system and make possession of these, you know, death-producing toxins illegal, there is a reaction to it. And I don't understand it, because I don't understand why anybody should have to have these things unless you're part of a legitimate, certified research lab.

MR. ATLAS: I think -- I agree with you. The ASM has agreed with that basic tenet. I think there is a sense, in part, among universities of regulations, of how we are able to deal with regulations, that will cause some heartburn for some administrators. But there also has been some concern that we could cause people to destroy legitimate cultures; that legitimate researchers would walk away. I think as long as --

SEN. FEINSTEIN: Well, what's wrong with that? If all these things produce death and can be misused, why would we worry if they destroyed them?

MR. ATLAS: Because we need the researchers to find the vaccines and the pharmaceuticals. If we destroy the cultures and we do not have legitimate researchers doing research on anthrax, we will not have the drugs and the vaccines in the future to combat any bioterrorist attack. Much of that research goes on at our universities, as well as in the federal labs and other industrial laboratories. That's absolutely critical to the welfare of the nation.

SEN. FEINSTEIN: Is the toxin or the virus or the pathogen in the possession of the individual or the lab, when you work for a lab?

MR. ATLAS: I think it ought to be in the possession of the laboratory, and then we need to look at who has access to that within the laboratory. But it never should be removed from that laboratory setting. It is in that setting where the appropriate biosafety and biosecurity measures are in place and where the CDC can ensure to oversee them.

SEN. FEINSTEIN: And today they are removed from the lab?

MR. ATLAS: Not that I know of. I mean, obviously, someone has taken an agent now from somewhere and spread it, but to my knowledge, legitimate researchers do not take these agents home; they do not remove them from the laboratory setting. They would not endanger the public that way.

SEN. FEINSTEIN: The USA Patriot Act signed into law by President Bush prohibits certain restricted individuals, such as dishonorably discharged veterans, felons, fugitives, illegal aliens and drug users, from possessing or transferring any select agents. Do you believe these restrictions are appropriate? Are there any classes of individuals who should be on the restricted list who are not?

MR. ATLAS: I think we think that that list is appropriate. I think, as I indicated in the testimony, the only thing that we might have liked to have seen was the authority resting with the attorney general to grant an exemption, if it was in the national interest.

SEN. FEINSTEIN: Let me just be clear. The attorney would essentially have a waiver of these things -- be able to appoint, to give a prior felon --

MR. ATLAS: It was the recommendation of the ASM, as this was being developed, that the secretary of HHS be able to make a recommendation to the attorney general on an individual basis to grant an exemption if, indeed, it was in the interest of the United States to have such an individual have possession. Now, that may never have occurred, but we do think that at that level, it's appropriate for government officials to be able to say we need an expert.

Let's say that we had someone come from Iraq who could provide expertise, who currently would be, under the U.S. Patriot Act, excluded. If the secretary of HHS and attorney general said we really need this person, we think we should provide that ability.

SEN. FEINSTEIN: All right. My red light is on, but in the next round I do want to ask you about the current registration requirements.

So I'll defer to Senator Kyl.

SEN. KYL: Thank you. Is it Mr. or Dr. Atlas?

MR. ATLAS: Dr. Atlas.

SEN. KYL: Dr. Atlas, I'm sorry. You testified there are about 250 university-related, or university, labs that would have access to these materials, but you were not identifying the number of non- university labs, is that correct?

MR. ATLAS: That's correct. We did not do our own survey of that. There have been publications from --

SEN. KYL: Do you have an estimate -- do you have any estimate based on other publications about how many other labs might also --

MR. ATLAS: From the total number that we've seen in the list, there's about 550 within the United States.

SEN. KYL: Okay, thank you.

SEN. FEINSTEIN: In addition to 250?

SEN. KYL: No, total.

MR. ATLAS: No, total 550. So --

SEN. KYL: Half university, half other?

MR. ATLAS: Yeah.

SEN. KYL: Okay. Now, with respect to the equipment, let me just understand how sophisticated this equipment has to be. Let's take the kind of anthrax spores that were mailed in the Daschle letter, because there's at least some information about the quality of those spores. Can you give us some sense of the kind of equipment that would be necessary to produce that, and how ubiquitous that equipment might be and how sophisticated it might be, and whether there is any point in trying to regulate somehow the possession of that particular equipment?

MR. ATLAS: Let me divide that into two, part of which I can answer. It is easy to grow the organism; it's easy to isolate the organism, even from nature, if we do not get it from a laboratory, and that equipment is very widely dispersed. I couldn't begin to count how many laboratories have that capability and how many of us who have been trained as microbiologists have the expertise to isolate and grow, up to a point where you could create a biocrime, but not the bioterrorist sort of event that we're seeing.

Beyond that, frankly, I can't answer the question because I don't have the knowledge of how to go from that state to creating a true bioweapon as has been described as the spores in the Daschle letter. That's more an engineering phenomenon of milling or other technology to bring it into a form where the electrostatic charges have been diminished, where it can be come aerosolized. So not knowing sort of that step, I can't answer the question as to how many individuals would have that.

Given the ubiquity of the microbiological side of the equipment, if I was going to look at equipment to regulate, I would look at that engineering side of the milling equipment, and that's sort of been also discussions that I've had in negotiations on the Biological Weapons Convention, where equipment has been at the fore of what we might in fact look at.

SEN. KYL: We'll need to define more precisely, if we're going to identify any equipment, what that might be, and I look forward to working with you.

I have a question for you, Mr. Paraccini, but do you have any addition to that last question?

MR. PARACCINI: I guess the only thing that I would add is -- and I know that the scope of the jurisdiction of this committee is largely domestic -- we should also keep in mind that there are lots of foreign universities and laboratories, and we should get a handle on our own problem first. We should be aware that other places, there's not near the accountability as we have in this country, and this problem may be global in scope; indeed, the Ames strain of anthrax has been sent around the world for years. So even if we get our own house in order, which is not an easy task, we've got another sort of circle of challenge before us.

SEN. KYL: Excellent -- excellent point. Now, in the introduction of your background, there was mention of your work in radiological as well as biological threats. Could you comment, on discussing this new paradigm, how you would fold in the radiological threat with the kind of legislation that you hear us talking about here today, or anything else that you would recommend? And by this, I'm distinguishing between the nuclear weapon and the infusion of radiation-producing materials into some other kind of weapon which could then disperse them in a widespread way.

MR. PARACCINI: I think your line of questioning, Senator, is very good and we, I think, focused too much in the last six years on sort of weapons-grade or military-like weapons falling into the hands of terrorists. That's important and a concern, but the probability of that is low; albeit the consequences could be quite high, but the probability is low.

What's much more likely is industrial chemicals and hazardous waste being used inventively as weapons, because they're much more present and the regulations on them are not near that which there are on nuclear power plants or, indeed, on nuclear weapons. So much more attention needs to be paid to this more readily available material that could be used as a weapon. After all, we saw a group of people turn a passenger aircraft into an incredible weapon. It's not that difficult to go the next step and turn a truck of hazardous waste -- that are being shipped around for legitimate industrial purposes all the time in our country -- turning that into a weapon as well.

SEN. KYL: Well, do any of you have a comment specifically with respect to radioactive materials that could be used in this fashion? Or should we --I mean, we can talk to other people about that; I just wanted to see if any of you did. No? Okay, that's fine.

We appreciate very much the expertise that you've brought to bear here and, as we develop legislation, we'll want to make sure that we cover all of the bases in terms of registration and certification that's required, but also realize there are some new trends taking place and that bad guys won't follow the law and, therefore, to balance the legitimate needs of science, the realization that there are certain kinds of people who, however finely we draft this, aren't going to comply, and therefore try to balance the way that we legislate in a way that will do the most good to protect our people and do the least damage to the scientific inquiry that we all support.

Thank you, Madame Chairman.

SEN. FEINSTEIN: Thanks, Senator Kyl.

Senator McConnell?

SEN. MCCONNELL: Thank you, Madame Chairman. Dr. Atlas, did I hear you correctly, in response to one of Senator Kyl's questions, that it's beyond your area of expertise to know whether there is equipment that is specific to the production and so-called "weaponization" of biological agents?

MR. ATLAS: Yes, that's correct. I think that goes outside of the realm of microbiology. Microbiologists would take something to a point, but then, at least my understanding of how one would weaponize anthrax spores, is more an engineering feat of getting the right particle size in the two-micron range, the uniformity, the charges. That's not something that we train microbiologists to do or that I would know how to do.

SEN. MCCONNELL: I'm assuming there's somebody out there who could answer that question, which we may need answered in order to decide what, if anything, to regulate in order to reduce the threat of bioterrorism. That is a question we do need answered by someone, right?

MR. ATLAS: I would think, sir, that when we turn to USAMRIID, that has some --

SEN. MCCONNELL: Would you pull the mike a little closer to you?

MR. ATLAS: Hm?

SEN. MCCONNELL: Will you pull the mike a little closer to you?

MR. ATLAS: I certainly can.

SEN. MCCONNELL: What were you just saying?

MR. ATLAS: I was saying I would turn that question over to USAMRIID. who had experience with the U.S. military operation prior to '69, who has a great understanding of what is in fact required to go from having spores to having a weaponized type of spore.

SEN. MCCONNELL: We've spent a lot of time discussing the measures that Congress ought to take to safeguard U.S. labs from potential terrorists. Obviously all of our best efforts might be moot if would-be terrorists are able to acquire biological agents overseas. As we move forward with these legislative initiatives, what in your judgment should we be doing internationally?

MR. ATLAS: I think we have to work for an international agreement that would criminalize bioterrorism. A number members of the scientific community has opposed such an act. We also need to harmonize the rules by which agents are exchanged and maintained. It does us I think little good to know who posses agents within the United States if we don't similarly know who possesses those agents around the world. It doesn't do us a lot of good to tighten our national regulations over the exchange or possession of agents, if one can go to another country and simply obtain them.

SEN. MCCONNELL: You estimated there were 500 or so labs in this country. I gather we have no idea how many there might be worldwide.

MR. ATLAS: Somewhere probably 1,250, 1,500 labs around the world would possess the select agents. It's a crude estimates --

SEN. MCCONNELL: Including the 500?

MR. ATLAS: Including the 500 -- so a thousand outside the United States would be a quick estimate of that. But that's a lot of places then who are not following the rules we currently do under CDC shipment regulations.

SEN. MCCONNELL: How might the various legislative initiatives we are considering here to control access to dangerous pathogens impact different types of laboratories? I think you touched on it earlier, but specifically how might they impact clinical laboratories for example differently from research laboratories?

MR. ATLAS: I think that there is a real difference between the research laboratory and the clinical laboratory. The research laboratory that is trying to develop a vaccine or a pharmaceutical is in true possession -- they know what they have, it's there, they're working with it -- it's easy to register those facilities. The clinical laboratories don't know when a patient comes in what they are going to isolate. They are not necessarily pre-registered to tell you, We are going to be in possession of anthrax. And in fact under the national laboratory network that we have established for laboratories, the local clinical lab doesn't really accomplish the identification -- that goes on to a public health lab or to the CDC to do. So the clinical lab may in fact be in possession, never know they have the agent.

Now, Senator Feinstein asked earlier about the CLIA exemptions under the current select agent rule. And in fact that's a necessary part, because we don't want to delay the shipment of the diagnostic specimen on up. As in the case of Boca Raton, for example, we had to get rid of that sample and not send it on, because they had not preregistered for potential possession of anthrax. We would have had a serious problem in knowing in fact that we were under a terrorist attack.

Now, those clinical labs need to follow a different set of rules. They need to destroy the agents once it's moved on. And that is in fact what the current select agent rule does. But there are tens of thousands of CLIA-certified laboratories -- probably something like 150,000 diagnostic laboratories in the United States. If we begin registering all of those who don't really possess the agents, then I think we have a mammoth bureaucratic nightmare ahead of us that doesn't allow us to focus the attention where it needs to be focused.

SEN. MCCONNELL: Thank you, Dr. Atlas. Thank you, Madam Chairwoman.

SEN. FEINSTEIN: Thanks very much, senator. Dr. Atlas and gentlemen, my staff has just handed me a copy of a list of categories of equipment that would be covered by the bill we are putting together involving this equipment. It includes things like sophisticated fermentation equipment, large temperature-controlled high-speed differential centrifuges, cross-filtration equipment, freeze-drying equipment, aerosol inhalation chambers, and certain modifications with respect to airplanes, trucks, et cetera. Would you take a look at this before you leave? And also, there's some bill language attached -- perhaps you would take a copy with you and give us your input on that, because I am sure there are things that we have missed.

The Anti-terrorism and Effective Death Penalty Act of '96 set up a registration system for laboratories that transfer and receive dangerous biological agents. The registration system that the CDC has a number of exemptions. In light of this new threat, I would like to ask you about the appropriateness of these exemptions. A, samples used for diagnostic verification and reference purposes: What is the American Society of Microbiologists' view of exemptions for diagnostic, verification and reference purposes? Why shouldn't a lab have to register if it keeps a reference sample of anthrax or smallpox permanently at the lab?

MR. ATLAS: I think the answer is if they keep a specimen beyond 48 hours they have to register, and should have to register. The only question on the exemption is the initial 48 hours during which a sample is being processed and sent on to be identified, after which they have to destroy it. So it's not that they should be able to maintain it. If they do, they have to register like any other laboratory under the select agent rule. The question, as I indicated a few minutes ago, is in the case of Boca Raton, don't we want that laboratory to be able to possess it long enough to move it onward for the proper diagnosis? But, no, senator --

SEN. FEINSTEIN: But it's also a loophole for mischief.

MR. ATLAS: I don't know that there's any way of closing that loophole when we are dealing with agents that occur naturally. In the senator's home state of California, where I lived before coming to Kentucky, we see several cases of plague occurring each year. The agent is present in various animal populations in the state. We need to be able to allow both the veterinary and the clinical diagnostic laboratories to make appropriate diagnoses. Then we must demand that they either register, transfer them to registered laboratories and destroy the agents within the set time limit. But, again, I would not want to prevent someone from making the right diagnosis that is going to save lives.

SEN. FEINSTEIN: All right now, let me ask all of you this question: Why do you think the FBI and the Justice Department are having such a difficult time determining the source of this? I mean, we know certain things about it that limits it to very few sources of production. So why is it so difficult?

MR. ATLAS: I mean, they are not here, and I don't want to comment -- but they have a culture that focuses on the crime and works backwards. And you might ask, So why haven't they worked backwards this far? Well, I think they followed the particular crime, and go back how that leads them, as opposed to sort of asking the question, What's the full realm of possibility here? -- and let's identify all the laboratories and all the workers, which would be one of the things one would want to do to have a complete baseline of what is the potential out there. But I think it's their cultural approach about how they pursue an investigation, which might be different -- or they might be aided by more regulation in this area that started with a clear baseline of what is out there and who has access to the facilities.

SEN. FEINSTEIN: So you are saying go immediately to these 500 sources?

MR. PARACCINI: Or whatever the number might be, because it could be a good deal more than that. I am sure that Dr. Atlas's laboratory is different, but you know people work with things in their laboratory, and then they move on to other places, and they forget what the bios are in the place where they worked, or people get sick and then die, and their laboratories still have the material in there. You know, mistakes happen.

A clear accounting of all of what is out there is probably a good place at some point for us to get to.

SEN. FEINSTEIN: Dr. Atlas?

MR. ATLAS: Senator, there also is an inherent difference between biological weapons and other sorts of weapons of mass destruction. If I fill this glass with water and it's a chemical, and someone takes half of it, you know it's gone. But if it's a biological agent, and I fill it with water, I need to take only a pinpoint out of there that you would never notice, and then I can grow tons of it elsewhere.

The other aspect that's different is with the exception of smallpox, all of the other agents occur naturally. One assumes right now that someone has gone into some laboratory or culture collection and obtained the strain of anthrax that is being spread maliciously through the mails. Reality is that that same strain undoubtedly also exists in nature and is killing animals, and one could have found it out there. Unless we eradicate these infectious diseases, terrorists will have sources of anthrax and plague, and any number of other agents in nature. And so while we definitely should tighten the regulations, from a biosafety and a biosecurity standpoint on our research and even our clinical labs, that does not eliminate the threat of a bioterrorist acquiring agents that can cause mass casualties.

MR. PARACCINI: And in fact, senator, I might add that it's worth remembering that Aum, the Japanese cult group, actually did go to Zaire thinking that they could acquire some Ebola virus. Now, they went in a period where there were not actually outbreaks. But they thought about it. So they did exactly that. And it may be more difficult to actually monitor who is going in and out of hot zones where there are emerging infectious diseases, as opposed to laboratories, where we know where they are -- for example in the former Soviet Union -- and can focus our attention in improving the security. We should do that. But we should also be aware of this more elusive source that pops up around the world according to its own design, and that it's hard to anticipate where it is.

SEN. FEINSTEIN: But, as everyone has said, this was highly purified. This -- and there was a substantial amount of it -- two grams in the envelope. And there was some kind of coding on it, as yet undefined as I understand it, which indicates to I think everybody that's looked at it a process took place that was a sophisticated process. So to me that has to come from somewhere. It didn't likely come from someone in their bathroom cooking this stuff up. It had to have come from somewhere. And then you get to the point -- Well, if it's two grams, why was it only two grams? Is there more? Is it three grams or four grams or five grams? And I guess if it takes certain equipment in certain labs to get that, it seems to me that no way no how in this country should individuals be able to possess that outside of the lab setting, which I gather right now our laws do not guarantee.

MR. ATLAS: If we could identify that equipment that went from A to B -- that is, that took the agent and refined it and treated it that way, and there is specific equipment, then I think I would agree with you, that we should not possess that. The other sort of equipment though, sort of going from just a cell of bacillus anthraces to two grams of material -- not weaponized, not purified. That, Iraq showed this could be done in very small containers, in very non-sophisticated ways, and that we would not be able to sort of capture or prevent individuals even from having the sort of jars and jugs at home that one could do that in.

SEN. FEINSTEIN: Well, now I am confused. You can't go to the level of this anthrax at home, right?

MR. ATLAS: In my opinion, you are correct. But it's after you have grown it. In other words, I think at the early part of being able to culture the bacteria, to grow two grams of bacteria, that is not a very sophisticated technology. Going from there to reducing the charge or the engineering aspects -- once you go out of my area of expertise of microbiology to someone else's area, in my view that becomes far more sophisticated, and it really is where the issue of equipment and a different sort of expertise that tells you how to make a biological weapon exists.

SEN. FEINSTEIN: Well, let me -- what do your microbiologists say? Speculate just for a moment. Now, this is pure speculation. Where do they think this kind of thing came from?

MR. ATLAS: I don't think we know. I think we really are looking and waiting, and we really don't know. And I'd say every day I get a phone call telling me it came from somewhere else -- "I know where it came from" -- and that night it changes. So I really wish I had a clue as to where it came from, who was responsible. I don't know.

SEN. FEINSTEIN: One last question. In the CLIA labs, the ones that are not required to register with CDC -- I trust you believe they should be?

MR. ATLAS: No. Again, those are the laboratories that are the diagnostic laboratories. They are required to destroy their cultures. Those are the laboratories like the hospital in Boca Raton that had the unfortunate experience of isolating bacteria from a patient who is dying of anthrax; and where they then transferred that and destroyed the culture, and did not actually register then as a laboratory that had been in possession, technically I guess, of anthrax during the time of the 48 hours when they had isolated it until it was transferred and destroyed.

Now, had they maintained it -- had they gone beyond that, then they are required -- they are not exempt -- then they are required to register. And that should in fact be done.

SEN. FEINSTEIN: You don't think it's worthwhile having CDC know? I mean --

MR. ATLAS: Oh, I think the CDC --

SEN. FEINSTEIN: Well, they do know. But --

MR. ATLAS: -- does know. I think that because there's a requirement that it move from that laboratory to a public health laboratory, that that is a requirement, that the public health laboratory needs to notify the CDC that there's no question that there's a record of where it came from.

SEN. FEINSTEIN: Okay. Okay. And what is the verification process when it's destroyed that it has been destroyed?

MR. ATLAS: I don't know that there is a verification process. And that is something that could be looked at in my view in terms of the regulatory oversight. As the secretary of HHS presumably in the near future, depending on which regulations we see come forward, will be charged with a new set of regulations. I think that is a very appropriate question of how that laboratory disposes of it and how we verify that it has been appropriately disposed. There is a requirement that it be either incinerated or autoclayed (ph) on site, but that verification --

SEN. FEINSTEIN: Right, we should add that --

MR. ATLAS: -- I think is a good point, senator.

SEN. FEINSTEIN: Right. Thank you very much.

Does anybody have a last comment they'd like to make?

MR. PARACCINI: I just have a comment about --

SEN. FEINSTEIN: Mr. Drake?

MR. DRAKE: -- you mentioned universities and the interest that people or the reaction that people have when they hear new regulations are coming down, and I just would like to echo what Dr. Atlas was saying. If they are participating in the process of defining what those rules and regulations are going to be, and having people working in the field who can say, Gosh, this is something that is likely to confer protection; or, This is something that is likely to be an unusual burden -- or what people are concerned about. So I just think that having an opportunity to participate in the development of what the regulations are so that they enhance our security, but don't then curtail the legitimate and beneficial purposes that are going on in the laboratories. I think that's one thing that's important.

Another comment I have in the concept of excluding categories of individuals with exception -- I think that that -- I would find that to be limiting in many ways. And I'll use an example of -- not necessarily good examples, but let's say someone who may have been dishonorably discharged from the military for sexual preference decades ago, or some other things like that -- there might be people who have had wonderful careers in research and other things that are really contributing to the national good, and by exempting or excluding entire categories of individuals without an opportunity for exception, I think that could be again limiting our ability to do legitimate quality work.

SEN. FEINSTEIN: Well, as was pointed out, there would be a waiver so that it could be waived. But at least the case would have to be looked at. One of the problems now is anybody can possess it. And I have a real problem with that. So --

MR. PARACCINI: Senator, I would just add --

SEN. FEINSTEIN: Mr. Paraccini?

MR. PARACCINI: -- that it's important that the committee and you and your colleagues look at not only the technology and sort of baselining what we have at our laboratories, but it's not just a matter of the material and the equipment, but there's also the know- how, and we have to be creative about how we secure the know-how of doing this, because as Dr. Atlas mentioned, the moving from developing a culture to actually making the sophisticated material that showed up in the Senate is an understanding about how you work with that material that really weapons scientists have had. And so there is the knowledge of weapons scientists and then there is the skill of doing that. So we need to be creative in thinking about how we control that or how we know where that is -- that is, the know-how and the skill, which are different. I realize that takes us into other committees' jurisdictions, but I think this is a problem that has many facets, and to look at only one part of it in isolation of the other, we may miss useful connections.

SEN. FEINSTEIN: Well, if you have some suggestions, we'd be happy to hear them.

Well, let me say thank you very much. It's been a very interesting hearing. I appreciate your expertise and the information that you have added for our consideration. So thank you, and the hearing is adjourned. (Sounds gavel.)

SEN. FEINSTEIN: Oh. Some senators have indicated they would like to submit written questions, and have requested that the record remain open until next Tuesday. And that will be the order. Thank you very much.

END

LOAD-DATE: November 7, 2001