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Discussion
Chairman BOEHLERT. Thank you very much. What we have now is a series of three votes. So—and we still have nine minutes and 46 seconds on the clock. So we will start with the questions and then we will have about a 20-minute recess. And I am sorry to inconvenience you, but the call of the House and the will of the people have to be served.
R&D Role in Homeland Security
Dr. Marburger, the R&D position in Homeland Security is technically vacant. And I understand you are filling that position right now, which may be a good idea. But do you have any sense in how we are going to go with that vacant R&D position in Homeland Security?
Dr. MARBURGER. You would have to ask Director Ridge that question. For the time being, he is relying on OSTP to marshal the necessary technical support. That is an efficient way to do it at this point because the structures of interagency coordination do already exist. And, as you have heard, we are in good communication with the necessary technical agencies. I am satisfied that we will continue to be able to provide the technical support through these mechanisms for as long as it is necessary to do so.
Coordination of Bioterrorism Response Efforts in the FY 03 Budget
Chairman BOEHLERT. All of you are going through the exercise right now with OMB for the '03 budget. How is bioterrorism fitting in, in your discussions? And I will ask each of you, starting with Dr. Henderson. I assume we have their attention.
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Dr. HENDERSON. Yes, Mr. Chairman, we certainly do. And there are very active discussions going on at this point in time. And I think it is probably out of order for me to be commenting more specifically than that at the moment. But clearly we are very actively engaged in this every day at the present time.
Chairman BOEHLERT. But what I am really driving at is the coordination issue. I would think that OMB is not going to treat each of you in isolation, not factoring in what the other might be doing. And so the coordination part is so vital as we look at this. So I would hope that there are extensive conversations, not just individually, on what HHS might need, but what HHS and DOD and EPA and—the coordination issue is what I am really driving at, Dr. Henderson.
Dr. HENDERSON. I have not been involved in those discussions if they have taken place. I think they are—the budgets at this moment are still being looked at pretty much independently. We do have a lot of discussions with our colleagues in the different departments. And—but I do think there is a place for more of the discussions you are talking about to better coordinate these efforts.
Chairman BOEHLERT. Shortly we will give you the opportunity to have a little conversation as we go for 20 minutes and you might put your heads together right here.
Dr. HENDERSON. Right.
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Chairman BOEHLERT. Dr. Johnson-Winegar.
Dr. JOHNSON-WINEGAR. Yes. I would certainly agree that the level of coordination and communication between our departments has seen a significant increase. I would particularly like to comment on the Department of Energy, who is not represented here today, as well as the Department of Health and Human Services, who, at the moment, I would characterize as the primary coordinators with DOD in our research efforts on the bioterrorism effort.
Chairman BOEHLERT. Ms. Fisher.
Ms. FISHER. Yes. Mr. Chairman, our '03 budget actually went to OMB on September 10, and it didn't reflect very much bioterrorism, although there was a small part. Since then, obviously, we have done a couple of things. One is, both as part of the '02 supplemental process, work with OMB, as well as shape an '03 add-on that dealt with bioterrorism. The Office of Homeland Security is—has also received the information that we supplied to OMB and they are playing a role, I think, that you described, which is to look across the Agency's budget requests and be sure that they can be read together. And I think Governor Ridge sees for himself a significant role in working with OMB to develop a comprehensive Administration budget that deals with bioterrorism.
Chairman BOEHLERT. Dr. Marburger, I should imagine your conversations with Governor Ridge are most interesting. Would you care to comment on that question?
Dr. MARBURGER. Governor Ridge does have the responsibility for coordinating the requests from various agencies for funds in support of bioterrorism activities. And he has taken that responsibility very seriously and worked closely with OMB to clarify the requests and to make sure that the money is there that is required to respond.
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President Bush has an enormous commitment to homeland defense and the war against terrorism, and has obviously made it clear that he expects necessary financial support to be made available to do what is necessary to protect American citizens and the world against global terrorism.
I have been fortunate enough to be involved and to be present during discussions of the cross-cutting budget on bioterrorism. I heard Governor Ridge's presentation to the OMB examiners, and I can assure you that this is going forward in accordance with the wishes of President Bush.
Chairman BOEHLERT. Thank you very much. We have four minutes to go for a vote, so we will go into a temporary recess and we will get over and back as soon as we possibly can. Please take advantage—if you would like to use our lounge, the four of you, for continuing discussions on the '03 budget and the necessity for coordinating, we will make that available to you.
[Recess]
Chairman BOEHLERT. Let us try to get the Committee reconvened. The Chair recognizes the gentleman from Texas, Mr. Hall.
Threat From Anthrax Spores
Mr. HALL. Thank you. Dr. Marburger, maybe I ought to ask you this. Why don't we start off with 1A for the record and to lead into the questions I have. Just put it on the record as to what a spore is.
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Dr. MARBURGER. A spore is like a living bacteria that has gone into suspended animation. It kind of draws into itself. It is like—it is more or less like a seed. And under the right conditions, when nutrients are around, it gets moist, and it kind of unfolds and becomes alive again. So you often see spore-forming organisms when there are hostile environmental conditions and it has to survive a period of drought or being without nutrients for a while. And then it sort of draws into itself and looks like a seed—so its metabolism goes to zero basically and doesn't wake up again until conditions are right. So the spores typically are harder to kill. They are smaller, tougher.
Mr. HALL. How small are they?
Dr. MARBURGER. The——
Mr. HALL. Or how are—are they varied sizes?
Dr. MARBURGER. They are various sizes. They——
Mr. HALL. If so, from what to what?
Dr. MARBURGER [continuing]. Just tend to be on the order of 10 microns or less. They are very small. But they can be filtered. I think Ms. Fisher has indicated support for the HEPA filter technology as one of the ways that we can reduce our risks in buildings and open, and enclosed, spaces.
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Mr. HALL. Is it a fair question to say how many spores are required to infect a person?
Dr. MARBURGER. It is a fair question. I would refer it to Dr. Henderson to answer. He has a lot more expertise than I do on this.
Mr. HALL. And anytime you want to turn around and ask your staff, I have found that my staff knows a lot more than I know about what I am talking about—feel free to do so.
Dr. HENDERSON. I am happy to respond to that. And I think there are figures that have been quoted as to the number of spores that is commonly called an LD–50 or an infectious disease 50 dose. That is, the number of spores necessary to infect 50 percent of a group of monkeys. And this is usually quoted in the order of 6,000 to 10,000, or 12,000 spores. But that means 50 percent of them have less than that. And how few can they have(see footnote 3) has been a question we have been asking ourselves. Is it possible that one spore actually could generate an infection? It seems unlikely, but then is it possible? And I think the answer we would have to say is, maybe. We would like to—could—either is there some science we could do to evaluate this more thoroughly, and we are trying to figure that out at the present time.
Mr. HALL. Nations have agreements that go all the way from our agreements to limit the use of nuclear weapons and on back to World War I when they were afraid of mustard gas, and a lot of people coughed and wheezed their way through life after that war. Do you see—do you envision a time when we will push this off to one side like that and expect that nations won't use it? You know, they didn't really use it on a wholesale thrust in the war since that time, but we have always had the fear of it. Are we going to let the fear push us into over-search or over-precaution, or is there any such thing?
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Dr. HENDERSON. One would hope that somehow or other we could put the biological weapons genie back in the bottle and be done with it.
Mr. HALL. If you had an honorable enemy that can happen. And that—we are having problems with that right now.
Dr. HENDERSON. And we have the capacity to work in microbiology to grow organisms and to put different organism—pieces of different organisms together, and there are techniques in laboratories which are far more numerous now and growing more numerous all the time. But I am afraid we have and will have to live with a threat that is out there.
Mr. HALL. Dr. Henderson, most things I have read and that have been advised about is that as few as a thousand spores, a number that emerged from the old TA studies. Is that—do you agree with that—could cause the—well, say, the problem that the 94-year-old lady had. I guess, do you really believe that she was exposed to as much as a thousand spores? If that is kind of the minimum—or are you saying the minimum is one or do you—you just don't know?
Dr. HENDERSON. No. I think we don't know, however, there is a fair amount of experience in the past from the 1950's and '60's. For example, we had the epidemic in Russia of Sverdlovsk. And looking at all of this example, in Sverdlovsk, there were probably on the order of about several hundred cases. The cases came down between 2 and 46 days after exposure. There were obviously spores that went into the ground and were around all over the place. They did not clean that up very well at all. And yet, we had no more cases after the 46 persons infected. In other words, the spores that were there were adherent to the surface of the ground and whatever else there was and did not come back up again in what we would call a secondary aerosolized infectious form.
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Mr. HALL. I guess it is as baffling as the old—as the elderly ladies when they didn't—I am told, didn't find a single spore in her home and her mail and her garbage and just found traces of it at the local postal facility there and maybe at a neighbor's home, just a trace of it.
Dr. HENDERSON. But it is——
Mr. HALL. But nothing like a thousand spores.
Dr. HENDERSON. Yes. This is right. And we—it does not—her infection, if it was derived from an envelope or what have you as sort of a secondary contaminant there, does not make any sense from what we know scientifically.
Directions for Anthrax Research
Mr. HALL. One last question—and I know my time is up. What is the answer—what—direct us research-wise, because that is what this hearing is all about.
Dr. HENDERSON. I think we would like to know a great deal more about the behavior of anthrax, especially its capacity to infect other people with subclinical infections. Do we have some sort of background of anthrax infections? We don't think so. I think there is a lot of practical in-house laboratory work that is needed. I think we need to move quickly to get a better vaccine than we have now. I think we would do well to—particularly to develop something which would permit us to treat a case of anthrax after it occurs. That is, to neutralize the toxic effects that the organism produces. There are a number of different avenues that I think we need to pursue.
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Mr. HALL. I have many more questions, Mr. Chairman, but I yield back at this time.
Chairman BOEHLERT. Thank you very much. Dr. Ehlers.
The Public Health System and Anthrax Vaccines
Mr. EHLERS. Thank you, Mr. Chairman. I have a specific question for Dr. Henderson and then a more general question for everyone. Following up on a comment you made and on Ranking Member Hall's question. You commented that—you decried the deterioration of the public health infrastructure. I totally agree with you. When I served in the Michigan Senate, I chaired the Appropriations Committee on Public Health and tried to make some changes there, but it is very difficult. The public support is not there, political support is not there. Maybe it will be after this.
My own theory is that once antibiotics were developed, people said, oh, we don't need public health anymore. We just take medicines. But following up on that, when I chaired that Public Health Committee in Michigan, we were the only source of anthrax vaccine in this country. In fact, I think, in the entire world. And that has fallen on hard times for various reasons. I am a very—I have been very concerned about that for some years. I spoke to the Pentagon last year to the person in charge. He said, well, don't worry about it because those vaccines wouldn't do much good anyway, because the Russians have developed variants on spore and the bacterium that can't—this vaccine doesn't prevent.
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I thought that was not a particularly helpful attitude. And I understand HHS is now talking about producing a lot of vaccine for anthrax. Is this going to be the same vaccine? Are they talking about producing something that will deal with the variants in the anthrax spores? Can you tell us what is coming down the pike on that, and is it worth our time and energy just to do a vaccine if it is not effective?
Dr. HENDERSON. The Russians did develop an organism which was a variant and which resisted the immunity that was conveyed by their vaccine. But theirs is a very different vaccine than our vaccine. It is a live vaccine. Ours is an inactivated vaccine with quite different characteristics. We don't really know what the nature of that organism is. We would like to be able to test it.
However, we do feel that there is a very good way to go in developing a vaccine because the vaccine really is acting against the toxins that are being produced. And it is the toxin—the specific toxin which is a real problem. I am optimistic that we will be able to develop a—what we call a second generation vaccine, something that would be easier to quantify in terms of the production level, and, secondly, might be able to be given with two doses, possibly three doses, but very few doses, and would have very few reactions.
Mr. EHLERS. A related question is the rush to produce smallpox vaccine now. And I understand that it is a long-term process and it may take five years, but yet we are being told that we can come up to snuff within a couple of years. Am I—do I misunderstand the process or are we really talking about a longer term agreement?
Dr. HENDERSON. No. We have had extensive discussions with the manufacturers about how one proceeds and might proceed and we have looked at timelines and there are some very good scientists out there. We are convinced that we will have that vaccine available by a year from now, 12 months from now—the full amount—the 280 million doses.
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Mr. EHLERS. And then we have the tough ethical question—should everyone take it when some people will suffer from it. But we won't get into that here.
Dr. HENDERSON. Okay.
Threat Assessment and Risk Assessment
Mr. EHLERS. All right. I do have a question—a general question for everyone. And it seems to me that one of our big problems is the lack of research or the—and also, therefore, the lack of knowledge about threat assessment and risk assessment. And I was appalled when we had the first anthrax case and we, in our office, as essentially lay people, were talking about what this risk might be, what the threat might be. And it appears that the people who were involved weren't having those discussions, particularly with the answers that were given to the postal officials when they asked about the threat or about the risk.
What is being done, in each of your agencies, to deal with both the threat assessment of the likelihood of various types of things occurring and also in the risk assessment? How do you deal with it? I don't understand the CDC, in particular, saying now we have to have zero contamination—we have to clean up to zero contamination. When—and I am wondering if that is their overreaction because they were, in part, responsible for saying the postal authorities didn't have to worry about it. I would appreciate a response from each of you on what we are doing to analyze the threat and the risk. And can you identify, in any way, the likely threats in terms of types of bioterrorism?
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Dr. MARBURGER. Everyone is looking at me.
Mr. EHLERS. That is because you are the new kid on the block.
Dr. MARBURGER. There was, as I mentioned in my testimony—and I don't know if it was in the part that I read or not—there has been a cross-cutting committee on Prevention of Weapons of Mass Destruction which has an R&D subcommittee. That Committee was originally formed under the National Security Council structure. There was an R&D subcommittee that included working groups, including bioterrorism. That committee, in the aftermath of 9/11, is being transitioned to a committee on bioterrorism under the NSTC structure and continues to meet and discuss issues like this. I am not prepared to describe in any detail the functioning of that committee and the extent to which it has considered threat assessments. But that is one of the cross-cutting mechanisms that we have.
Of course, I am aware of activities under the aegis of homeland security and the Department of Defense intelligence agencies that are directed toward threat assessments. I make a distinction between threat assessment and risk assessment.
Mr. EHLERS. Yeah.
Dr. MARBURGER. Threat assessment is extremely difficult. You have to imagine a scenario and then you can analyze the scenario and attempt to understand the various dimensions, including response and the extent to which it poses a risk economically, to public health, food supply, etcetera. So these are questions of enormous complexity that we are just, I think, beginning to grapple with in a systematic way, although there have been—there obviously has been a long history of trying to understand bioterrorism.
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Again, Dr. Henderson has led an institute that has considered some of these issues—many think tanks, the RAND Corporation itself. And the urgency now is to assemble this work and try to find out where—what is of value for homeland security and fill in the holes with research proposals. And this drawing together of these threads is one of the responsibilities of homeland security and that is the locus or the focus of activities, although we will all be providing technical support for those activities.
Chairman BOEHLERT. The gentleman's time has expired. Mr. Etheridge.
Military Focus
Mr. ETHERIDGE. Thank you, Mr. Chairman. And let me thank you for convening this hearing and, for the witnesses, for your testimony thus far. I appreciate it very much. Let me take a little bit different road, but it is all connected. I had a whole host of questions I wanted to ask, and I am sitting here listening and all of a sudden I realize that, as I think about this, the reason this is so different than anything we have dealt with before in bioterrorism and the issues is, historically, it has been a military focus. We have not had this issue as it relates to the total civilian population. I think that is something that we are grappling with, that we have never dealt with in this country before.
So let me ask the question this way, and I may want to go to Dr. Winegar first—Dr. Winegar—and then we will spread it out. Because historically, when the Cold War—we were involved in the Cold War, and the military, by and large, took the lead through civil defense. We set up civil defense with a whole host of things because the major concern dealt with the military apparatus. That is still a part of it today.
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In this whole issue of bioterrorism, what is the military doing? Because it seems to me that as you relate to that—this time it was in Washington and in the post offices—but there are—in my district, I happen to have Fort Bragg and Pope, or close to it. We are adjacent to it. There is a large civilian complex adjacent to that and it is true all over this country, as well as populations, such as Washington, the one it hit. What is being done in that area as it relates to the research? It is important that we protect our warriors who are out there, but we have got to also look at their families who are back home who are now are probably more vulnerable ever in history?
Dr. JOHNSON-WINEGAR. You are exactly right. And the military focus has been on the war fighter and we have tended to think of that war fighter in an overseas situation, fighting in a setting that may not be the most likely one in which we will encounter biological agents. As I mentioned before, I think a lot of the technologies and material that we have developed primarily for use by the war fighter can easily transition to the civilian setting. Some not so easily and some otherwise.
We, in the Department of Defense, have identified an initiative to look at protection of all of our military bases, which would include things such as provisioning them with the biodetectors, that I showed you earlier, additional protective gear, masks, suits, etcetera, as well as medical countermeasures. And that proposal is under review within the Department of Defense right now.
As I am sure you are all aware, there are over 500 military bases alone, some small, some large, and that extends to quite a number of people. And then, of course, we have to remember what the role is for the Department of Defense in the civilian sector because biothreat agents don't recognize boundaries between countries or between where the edge of a military base is and the surrounding community. So it is obviously a problem for us.
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We are making a significant increase in our research programs in what we call modeling a simulation. There is an awful lot of work that needs to be done to help us understand the transport and diffusion of biological agents. While the military has done a lot of work in the past, we have traditionally looked at more or less open spaces. And now, when we try to think about things in an urban environment or even just inside one particular building, those are some areas where a lot more research needs to be done.
In getting back to some things that Dr. Henderson pointed out earlier, I think we need to have a better understanding of how we can predict the lethal dose or the infective dose of many of these biothreat agents. We are using extrapolations from animal data. Much of that data was done in previous years when we weren't as good at quantifying, for example, the number of spores that it might take to infect an individual. So there are a lot of areas that are ripe for research.
Disseminating Information
Mr. ETHERIDGE. Thank you. Let me ask each one of you because my time is running out, because I think you have touched on something that is critical. I think we are very—we are woefully short in R&D in those areas. We are finding that out now as we try to decontaminate buildings. We really don't have the information we need. How are we working across agencies with the data we do have to share that data in an educational aspect rather than—because people are frightened, and that is the issue we need to get beyond, an educational process, so we have data that is accurate that we know we can decontaminate if it happens, but, more importantly, prevent or have whatever kind of antibiotics we need. Start with you, Dr. Henderson.
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Dr. HENDERSON. Yeah. I think, as Dr. Fisher has noted, there is a great deal of work going on with the CDC and HHS, in particular, with regard to the decontamination issues. And I think DOD is also involved with this. There is a lot of valuable information coming from their work in the 1950's and '60's. I think you hit on an important point, and that is, that we really need a major educational campaign to get the facts out to the people. And we intend to pursue this particularly aggressively. Because I think we have got to get to our physicians, to our health care deliverers, the people in the public health sector, and the public with a common message. And certainly, we will be working with our colleagues in the other departments to try and make sure we have got a proper message out there that does mesh.
Mr. ETHERIDGE. Let me add one thing, and that is, we do it—we did that with children who had civil defense. We do it with tornado drills, hurricane drills. We really need the information to get out so folks understand what we are dealing with, the severity of it. Because I think people just have no understanding right now.
Chairman BOEHLERT. The gentleman's time has expired.
Mr. ETHERIDGE. Thank you, Mr. Chairman.
Chairman BOEHLERT. But you hit on a very good point. And DOD, for example, is so far ahead in the R&D effort in a number of these areas. But past experience tells us so often what we spend taxpayer's money by the ton in developing for DOD purposes we don't share with the civilian agencies. And that is where Dr. Marburger and his team, and also Governor Ridge and his team, are so vitally important to make sure the left hand knows what the right hand is doing, and we are not unnecessarily duplicating costly research, but we are not missing anything, any opportunities. The Chair recognizes the Vice Chairman of the Committee, Mr. Gutknecht.
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Mr. GUTKNECHT. Thank you, Mr. Chairman. And first of all, Dr. Johnson-Winegar, I want to thank you for using, I think, essentially the same picture that appears in one of these brochures talking about the technology. And I do want to congratulate DOD. I think you have done a marvelous job since the Gulf War of working with private contractors to come up with ways that we can detect this. To follow up with the line of questioning, you know, it is one thing in terms of a tornado or other event. I mean, that is pretty—at least we, in the Midwest, have a pretty good idea when the chances are good for a tornado. But it is much more difficult when you are dealing with agents that are colorless, odorless, and tasteless. And at some point, we do have to do more in terms of the detection side. Now, I want to thank you for what you have done.
I really didn't have a question for you. I do want to turn to Dr. Henderson. I want to thank you because you have been a very valuable resource to this Committee and to Congress and you have been up here before visiting with us. And, frankly, I would like to essentially get on the record some things you told us not too long ago. Because I think there is a tendency, I think we need to be concerned, but we don't want to create panic. And that is a very difficult line to walk with the general public. So, Dr. Henderson, I would just ask you publicly, do you keep Cipro in your medicine cabinet?
Dr. HENDERSON. No. We do not.
Mr. GUTKNECHT. Have you had a smallpox booster shot?
Dr. HENDERSON. I haven't had. I probably have had in the hundreds of vaccinations during the time of the campaign. And I was consistently being vaccinated when some dignitary was being vaccinated and there was a good photo op. But—so I am probably hyper-immune at this time.
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Mr. GUTKNECHT. And do you keep a gas mask in your home?
Dr. HENDERSON. We do not keep a gas mask at home at all.
Mr. GUTKNECHT. And I wonder if you would just share with the Committee and others who might be interested some of your reasoning behind those decisions.
Dr. HENDERSON. Well, I think the reasoning that we have had on this is that, first of all, that the likelihood of, for example, a smallpox release is very, very small. And the probability of somebody getting the organism, doing all the work to grow it up and disseminate it, I think, it is not a very likely event. The problem is that if it did occur, it could be a catastrophe. And so to be prepared to respond quickly is the answer here.
If we move on to anthrax, I think it is easier to get—for someone to get hold of it. I think if we are, indeed, again, prepared to respond quickly and do our—have our people mobilized at local levels and hospitals doing the planning, that we will be in a much better position to deal not just with bioterrorism, but, let us say, a new strain of influenza or a new disease. We are seeing many more new diseases.
So that I think the preparation that we are going through has identified a problem that we have. It is a generic problem. Our hospitals are not able to accept a lot more patients. The health structure is weak. And these things need strengthening, both in the interest of bioterrorism, but for our own good, for other organisms.
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Mr. GUTKNECHT. So you are satisfied with the strategy which, I think, we are essentially adopting here at the Federal level, in how we would deal if there were an outbreak of smallpox—to encircle it, to vaccinate the people who had immediate contact, and then work outwards.
Dr. HENDERSON. Absolutely. And I think that is the best way to go.
Mr. GUTKNECHT. Going back to you, Dr. Johnson-Winegar, I did have a question for you. And that is, can you quantify for us how many questions or contacts you have had from other agencies about the expertise that you and the DOD have developed over the last number of years?
Dr. JOHNSON-WINEGAR. Well, I can't give you a specific number because I would have to categorize that as the contacts come in at a number of different levels. And as I talked earlier with the Committee, quite a few people make those contacts at the personal professional level. And I certainly encourage and think that that is a very strong way of doing things. So while an individual scientist at EPA or HHS or DOD may call a scientist in DOD, I have no way of tracking that particular number. I would certainly be willing to say that it is extensive.
Mr. GUTKNECHT. Good.
Dr. JOHNSON-WINEGAR. It is large. It is ongoing. And it is a very efficient way of spreading information.
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Food Supply Security
Mr. GUTKNECHT. In the last seconds that I have remaining, perhaps, Dr. Marburger, you could talk just a minute about our food supply. We have been fortunate, for example, in this country, we have not had the outbreak of what is referred to as Mad Cow Disease. And I am not sure I like that term. But what are we, and what can we do, to ensure that the food supply here in the United States is secure?
Dr. MARBURGER. That is a big question and it would require a long answer. But briefly, the same kinds of cross-cutting agency activities that have occurred in the past with respect to bioterrorism are also occurring with respect to food safety. It has been a topic of discussion at all the interagency meetings I have had. And during those meetings I have learned about activities that are taking place. It is being taken very seriously.
I had the good fortune, over the weekend, to meet with science ministers from other countries. And, at that time, I met David King, who is responsible for the UK response to the outbreak of foot-and-mouth disease. And I believe that we have lessons that we can learn from countries that have had these outbreaks and coped successfully with them. We hope to be able to learn from others as well.
Mr. GUTKNECHT. Thank you.
Chairman BOEHLERT. Thank you very much. Mr. Lampson.
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Mr. LAMPSON. Thank you, Mr. Chairman. And I, too, would like to commend you for the quality of this hearing and how much we appreciate all of the ladies and gentlemen coming. I am extremely concerned about agency coordination. And according to the General Accounting Office, there are more than 20 Federal agencies and departments that have a role in responding to bioterrorism.
And the issue of coordination is particularly important to me in my district. A company located in my district has recently announced that they have entered into discussions with the Federal Government and private remediation companies to dispose of anthrax-related waste from contaminated sites on the east coast. And I have been told by the company that this material will be transported by truck on interstate highways, the some 1,400 miles or so, from the east coast to Port Arthur, Texas, for treatment. And I wrote the Administration on November 21 and I have yet to hear back and I am most anxious to do so.
Disposal of Contaminated Material
And let me start with my questions, and I hope that I can get all of these in as I go through them. Are any of you familiar with a written plan that is in place to dispose of this material?
Ms. FISHER. Congressman, we—EPA is actively involved with the states as we look at how to dispose of any anthrax contaminated waste. We don't have a comprehensive Federal plan, if that is what you are asking. We are—but we are working with the different states and the facilities in those states about whether they are appropriate ones to accept the waste.
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Supervision of Cleanup
Mr. LAMPSON. Okay. Are there Federal agencies that are supervising all of the cleanups—all of the cleanups across the country, including those on private property, such as the NBC studios in New York, and American Media in Florida?
Ms. FISHER. EPA has been involved at different levels at different sites. We were not at all involved at the NBC or the ABC cleanup. They took care of that themselves through private contractors. At many of the other sites, particularly at the Postal Service facilities, we have been onsite and acting as a technical consultant to the Postal Service as they have approached those. At the other end of the spectrum, up here on Capitol Hill, we have been very involved with the incident commander here in the Capitol to help structure the remedy. So our involvement at sites has varied widely.
Mr. LAMPSON. Very——
Ms. FISHER. Varied widely.
Mr. LAMPSON. Oh. Varied widely. Okay. The lead agency—who would be or who is the lead governmental agency that will certify that any of these materials is, indeed, decontaminated before it is transported any distance, particularly that distance?
Ms. FISHER. Well, the material that is shipped has to be shipped in accordance with DOT infectious materials regulations. So in terms of its transportation, like the transportation of other, you know, hazmat materials, DOT has responsibility for the transportation end of it.
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In terms of the disposal sites, the EPA or the state licensing agency has responsibility to be sure that the sites that are going to receive the waste are technically capable of receiving it.
Mr. LAMPSON. Well, if DOT takes this on, are they going to assume the responsibility of anything that could potentially happen in the event that it is not completely decontaminated? Would they have that—would they assume the responsibility when they take control?
Ms. FISHER. Well, I don't think DOT is taking control. The waste would have to be shipped according to their regulations. But I don't——
Mr. LAMPSON. Okay.
Ms. FISHER [continuing]. Mean to suggest that——
Mr. LAMPSON. That I understand.
Ms. FISHER [continuing]. DOT was actually taking control.
Mr. LAMPSON. Who is the government contracting with to prepare to box this stuff up and to transport the material?
Ms. FISHER. Where EPA is involved in the sites, we have response action contractors who would have to be—would—who would be responsible for being sure the waste is properly packaged.
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Mr. LAMPSON. Okay. Will it be guarded and escorted?
Ms. FISHER. Not to my knowledge.
Mr. LAMPSON. Okay. Are there other sites that have been at least explored that could potentially be closer to the contaminated sites that might be better able to dispose of this than the one 1,400 miles away?
Ms. FISHER. I would have to get back to you on what kind of analysis has been done. To date, a lot of the waste has been incinerated. And so I would have to get back to you about what we know in terms of the analysis that has been done.
Mr. LAMPSON. Thank you. What concerns me is that we have heard experts testify before this very Committee on November the 7th that there was a lack of consensus about what exactly constitutes a safe environment following decontamination. And even EPA Administrator Christine Todd Whitman testified before a Senate Appropriations Committee last week that, as you have here somewhat, we are writing the book as we go along. I believe it is the responsibility of elected officials to avoid any action that increases public anxiety.
And I want to know what steps are being taken to certify that this material is safe and decontaminated before it is transported halfway across the country for treatment, and I want to know the chain of custody from the absolute beginning to end. And if you would provide additional information for me, for the record, I would most appreciate it.
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Ms. FISHER. Congressman, we would be happy to come up and talk to you about everything that we are doing in terms of the managing or the handling of the waste that comes off these sites. Obviously, it is all different kinds of waste and we might be treating them—some of them differently. But we would be happy to come up and work with you and your staff.
Mr. LAMPSON. I would appreciate that. My big concern is that we haven't sat down and thought out a plan before acting. And if something happens later, then we are going to have to be thinking on a fly, and that is what we are trying to avoid. Thank you very much.
Chairman BOEHLERT. The gentleman's time has expired. And, Ms. Fisher, I would appreciate it if you would provide the Committee with a response in writing. And that does not preclude a personal briefing for Mr. Lampson. And very——
Ms. FISHER. We would be glad to do both.
Chairman BOEHLERT. All right. Thank you so very much. And we will share it with the Full Committee. The Chair recognizes Dr. Bartlett.
Production of Doxycycline
Mr. BARTLETT. Thank you very much. I have been told that approximately 1.5 billion capsules of Doxycycline are being acquired to increase the national pharmaceutical stockpile. Are these capsules or capsule materials made in China? Who can speak to that?
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Dr. HENDERSON. I don't—the capsules themselves—my understanding is that they are not, but that the basic materials, the first level of synthesis of these, is carried out in China and in India. I think there are plants, I have been told, in both places. I don't know this terribly well. And that is that material which then is processed further in the United States and made into capsules or tablets.
Mr. BARTLETT. Does this violate the Buy America Act?
Dr. HENDERSON. I have no idea, sir. I really don't know.
Mr. BARTLETT. I wonder if we investigated to determine if there might be a U.S. company that manufactures all of the ingredients or capsules that are needed in this acquisition.
Dr. HENDERSON. And I have—again, I can't answer that question at all. I—and what I am giving you is a—information that I was given rather casually. We have not gone into an investigation of where and how they are made. But we can——
Mr. BARTLETT. Could you, for the record, provide us information——
Dr. HENDERSON. We can get that.
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Mr. BARTLETT [continuing]. As to what parts of it are made in China and also tell us whether or not we determined that it was, in fact, impossible to have this made in America?
Dr. HENDERSON. We can do that.
Vaccines vs. Antitoxins
Mr. BARTLETT. I thank you very much. Earlier testimony before this Committee contained recommendations not to rely on specific vaccinations as a protective measure. Rather, to develop stockpiles of effective antitoxins to be deployed right before or during or right after an outbreak. We do this, of course, with tetanus antitoxin. Would you comment about the present thinking as to the best way to protect our citizens? Is it through vaccinations or is it through antitoxins?
Dr. HENDERSON. I think, in general, we would prefer to give vaccines as a protective rather than to be reliant on treatment afterwards. But this very much depends on the type of organism we are talking about. With smallpox, we are talking about getting a vaccine, but not using it unless the threat is greater than we now perceive it to be. And thus to have it ready to use. But there is no antitoxin available for that.
We do have botulinum organisms which produce a toxin, which can cause paralysis. And for that, we treat that with antitoxin. We—the question is should we be developing a vaccine, and this may be the disease you are thinking of, or the organism, because it is a unique one among the ones we are worried about. There is the possibility of developing vaccines, but there are, I think, five different types that one would have to develop the vaccine for. And this we are looking at the question of how do we deal with botulinum cases and what is the cost of doing so? What are the problems in doing so? And, again, what is the risk that this organism poses because it is not easy to make either the antitoxin nor the vaccines. They are complex, costly, and is the risk that great? And we—this we need to look at.
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Mr. BARTLETT. Is it true that antitoxins are less strain-specific and, therefore, better protect against possible mutant agents that might be developed by an enemy?
Dr. HENDERSON. I would suspect that that may be true, that you probably have less likelihood of having a mutant organism that would be involved. The toxin is probably more likely to be the same no matter what. But the difficulty is, is treatment with an antitoxin is very difficult. If you have any number of cases, this would be a difficult project to deal with. I think that botulinum is a particularly difficult problem that we really don't have a simple answer for.
Mr. BARTLETT. But for those agents where a mutant is possible, wouldn't we be advantaged by developing both the vaccine and the antitoxin so that we would have two courses of protection?
Dr. HENDERSON. I think that would depend very much on the organism. We are dealing with some viruses, some bacteria. With botulinum, we are dealing with a toxin. So that the different organisms are affecting people in different ways. And I think one has to look at each one of these separately to try to decide what is the best approach.
Mr. BARTLETT. We are plowing new ground, of course. I thank you very much, Mr. Chairman.
Chairman BOEHLERT. Thank you very much. Mr. Matheson.
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Coordinating Federal Response to an Attack
Mr. MATHESON. Thank you, Mr. Chairman. I appreciate your holding this hearing. I have a series of questions I would like to ask. I will try to be brief in my asking of the questions. Dr. Marburger, I would like to ask you the following. In a couple of months, the Winter Olympics are going to be held in my district and a great deal of public concern has been generated over the potential terrorist risks. In preparation for this event, I have talked with many individuals from different agencies who are going to be involved in security at the Olympics. I know the FBI has been designated as the lead and the Secret Service and the National Guard are going to assist local police in providing security. I know that DOE's Basis Program will be tested there with involvement of the CDC. But in the end, I am still curious, if a bioterrorist attack were to occur, who will make the final decisions in terms of coordinating the response with Federal agencies and local responders? And is that a function of Homeland Security in your mind?
Dr. MARBURGER. Yes. That is a function of Homeland Security.
Mr. MATHESON. And is that going to be who coordinates the response, do you think, if something does occur in that circumstance?
Dr. MARBURGER. I am sure that Homeland Security will reach out to organizations like FEMA and others according to the plans that they have for their response, which is part of the planning for the Olympics event.
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Mr. MATHESON. But perhaps a more relevant question that the country in general is public attention is going to be focused on the Olympics during those 2b weeks in February—how would the Federal response be coordinated if an attack were to occur in a different location, be it a small town in southern Utah, like Moab, or someplace else in the country? Would Federal agents be deployed there and would the FBI still be responsible?
Dr. MARBURGER. I can't answer that question specifically, but my assumption is that we would respond in the normal way, taking advantage of the existing first-responder plans that we have now.
Priorities for Detection Capabilities
Mr. MATHESON. Let me shift to a different set of questions. In terms of setting priorities, there are so many different toxins that we could be looking for in terms of biological attack. What are the goals in terms of setting priorities for detection capabilities, in terms of numbers of toxins that you would like to have that capability in hand, the time in which the detection activity could be shrunk into something? Obviously, smaller times are better than larger times to do so. Do you have a sense of what the goals would be or should be?
Dr. MARBURGER. I don't. Those are technical questions that have been considered in the context of the DOD programs, and I will refer to Dr. Johnson-Winegar.
Mr. MATHESON. Right.
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Dr. JOHNSON-WINEGAR. Well, you are absolutely right. The list is large of toxins, bacteria, viruses, etcetera, that could be a bioterror threat for us. Within the Department of Defense, our goals are to develop the appropriate reagents for all of those things which are on the validated threat list. And if you are not familiar with the validated threat list, that is developed for us by the Defense Intelligence Agency and identifies those things that adversaries are working on or are capable of delivering to us. So that is our goal. Again, with regard to the type——
Mr. MATHESON. And how many are on that list? Can you tell me? Do you have a sense?
Dr. JOHNSON-WINEGAR. Without giving you the specifics, it is more than 20. If the Committee is interested, we can certainly provide a copy of—it is a classified document, but we can provide a copy of the threat list that the—that Department of Defense is working against, which is not necessarily the same list of threats that HHS or other organizations would use.
With regard to your question on time, our goal is certainly to get something which would provide a response in less than five minutes with the appropriate degree of sensitivity that we are looking for.
Mr. MATHESON. Do you have a sense of the resources, the resource requirements of pursuing those goals of completing that list that you have mentioned, whatever the number may be, and trying to reach a test that can be done in as short as five minutes as you suggested, a test that is reliable, that doesn't have a lot of false positives? Do you have a sense if the adequate resources are being provided now or what the cost might be to achieve those goals?
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Dr. JOHNSON-WINEGAR. Well, that is a good question. The objective is, is obviously to have the specific reagents required for each of the things on the list. And some of those are easier to work with than others and some are a higher priority than others. So within the resources that the Department of Defense has, we have allocated our work toward looking at those which are the highest threat and those which we think are the most important. And as we continue to work our way down the list, some of the technologies are pretty similar. So that if you have related viruses or related bacteria, it should get a little easier to develop the specific reagents.
However, once each set of those is prepared, you have to do all the necessary testing for sensitivity and specificity so that you don't get false positives and false negatives and look for cross-reacting material. So it is an iterative process. And then, of course, there is always the possibility that some new threat agent will be added to the list and we have to go back and do that. But clearly, it is a matter of months to years to develop the specific either antigen, antibody, reagent sets, or the primers that will be used in a PCR type of technology.
Mr. MATHESON. Thank you, Mr. Chairman.
Chairman BOEHLERT. Thank you very much. Mr. Grucci.
Technologies to Combat Bioterrorism
Mr. GRUCCI. Thank you, Mr. Chairman. And I also want to thank you for bringing this panel together and enabling these discussions to take place. Mr. Chairman, you and I have had the privilege of visiting the Brookhaven National Laboratory while it was under the direction of Dr. Marburger and we were able to see some pretty incredible things there. But bioterrorism is the least understood of the weapons of mass destruction. And because of its mystery, it is important that the scientific and technology capabilities throughout the United States be mobilized to help provide tools to anticipate, detect, and respond to the bioterrorism.
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I know that there is some work that is still proceeding, work that was undertaken when you were there, doctor, and things like the serial analysis of signature tags, practical molecule fingerprinting, which deals with detection and characteristics in the field, settings and buildings, as well as in battlefield conditions, the presence and types of biological agents. There is also a 3–D modeling of particle behavior in buildings with HVAC systems.
And I was just wondering if you—I know that you are no longer there, doctor, but if you could comment on these programs, their usefulness in what we are now experiencing, and how we might be able to integrate them into the battle on bioterrorism. I think the Committee would be better off for hearing that.
Dr. MARBURGER. Mr. Congressman, these are examples of technologies that have been developed in our national laboratories that can be brought to bear in current situations. And it is precisely programs like these that we all have a responsibility to evaluate and assess in connection with specific threat scenarios. And I am very proud of Brookhaven National Laboratory's capabilities in this area. It is part of a larger capability that the Department of Energy represents.
Shortly after the events of 9/11, that agency, the Department of Energy, moved quickly to assess its capabilities, asking every laboratory to make an inventory of what capabilities it might bring to bear, and that Department has made that list of capabilities widely available within the Federal agencies. And I am sure that all of these projects will get a good hearing if they receive wide exposure. The Department of Energy reached out, had an event in Washington here, where many examples of its products were displayed. And this is a kind of activity that I like to see, and I think will give us the best possible responses to the problems that we have.
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Mr. GRUCCI. Thank you, doctor. I know that the country is in good hands with you in the position that you are in. We miss you at the Brookhaven National Laboratory. One of the other programs that were started at the lab is the Urban Antiterrorist Technical Support Organization. Maybe you might be able to enlighten us as to what its responsibilities are to be and how we might be able to integrate that.
Dr. MARBURGER. Since I switched hats, I have forgotten a lot of the details of things like this, Mr. Congressman. I think I would prefer to say that that type of activity continues to be encouraged in the context of critical infrastructure protection and general programs of building protection.
It is significant that the State of New York and New York City, particularly, have attempted to increase the robustness of their systems, their public systems and so forth, and after the 1993 World Trade Center attack and have worked closely with higher education institutions and Federal laboratories, including Brookhaven, in the state, to develop more effective responses. I would like to think that the hideous events of September 11, perhaps, had consequences less than they might have as a result of this foresight by the State of New York.
Mr. GRUCCI. I appreciate your response to the questions, doctor, and I welcome you here as always. And it was a great privilege for me to be at your confirmation hearing and to present you to our Senate colleagues on the other side for confirmation.
I guess my questions really are complete except for perhaps one. Dr. Winegar, do you see any application in any of these technological advances that are happening at our laboratories, like what is happening at the Brookhaven Laboratory integrated into this battle that we are now undertaking?
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Dr. JOHNSON-WINEGAR. I see a tremendous opportunity to integrate advances from a number of different laboratories, both from those ongoing at Department of Energy, from our own Department of Defense labs, from those at HHS, as well as from academia and industry. And it is just a matter of going through the process and sorting them out with regard to their specific applications. But clearly, there is a tremendous opportunity in front of us at the moment.
Mr. GRUCCI. Thank you. And I would encourage you to speak to the good doctor here because he could probably help you understand the work that is happening at those laboratories. Thank you and I yield back the remainder of my time.
Chairman BOEHLERT. Thank you very much. You don't have any time to yield back. Ms. Jackson Lee.
Ms. JACKSON LEE. I thank the Chairman very much. Congress sometimes can be a good indicator relating to the concerns of the American people. And I thank the Chairman and the Ranking Member for listening to those concerns, which, at this point in time, are either regarding the terroristic fight, war, in Afghanistan, or their own particular and individual security. And so this hearing is enormously important, giving us guidance on what are our next steps. And that is the focus of my line of reasoning and line of questioning.
And I would like to start—and I want to also thank all of you for your presentations, but also for your work. Because I imagine many of you have sort of changed hats or elevated other expertise in order to respond to this global concern about homeland security, no matter where the world citizen may live.
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Agency Interaction With the Homeland Security Office
Tell me—if each of you would just answer briefly your interaction with Governor Ridge and the Homeland Security team. If each of you would answer—how do you interact? Is it yourself directly or is it someone you work with, and is it a day-to-day interaction? Dr. Marburger?
Dr. MARBURGER. Yes. I interact directly with Governor Ridge. I see him at senior staff meetings, which are held every day at the White House. And I also have a number of members on my staff that interact with his staff at the appropriate levels.
Ms. JACKSON LEE. Ms. Fisher.
Ms. FISHER. Yes. Thank you. Governor Whitman interacts directly with Governor Ridge, frequently throughout the week, on issues. Governor Ridge has established a Deputy's Committee on which sit the deputies of many of the departments and agencies that are involved in homeland security, and I sit on that. And we have been meeting somewhere between once a week and maybe three times a week. In fact, I am leaving here to go over there today. And the range of topics is very broad, but all obviously dealing with the homeland security issues.
And then he has broken up his council into a number of subcommittees. And EPA participates in a few of those that are targeted at areas for which we have expertise and responsibility.
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Ms. JACKSON LEE. Thank you. Dr. Johnson-Winegar.
Dr. JOHNSON-WINEGAR. Yes. From the Department of Defense, I have participated in two of the sublevel working groups that come under the purview of Governor Ridge's office. Our primary representative and interface is Secretary White, who is currently Secretary of the Army, but has also been designated as the Department of Defense's point of contact for homeland security. And in addition, Deputy Secretary Wolfowitz participates in the Deputy's Committee, as described by the Honorable Fisher.
Ms. JACKSON LEE. Thank you. Dr. Henderson.
Dr. HENDERSON. Yeah. The contacts are frequent between the Secretary and Governor Ridge, and we have two people from HHS on loan to that group to facilitate coordination. We regularly interact with General Bruce Lawlor, and I would say the contacts are often several a day.
Ms. JACKSON LEE. The reason I asked that question—and I thank you very much—but I am going to go into a series of questions and try to do those so that you can then respond—is obviously the first visit to the Hill by Governor Ridge was an organization one. He was in an organizational posture. I think it is absolutely crucial that the American people get a sense that we have gotten our hands around what is a very large set of issues that we have to address.
And I think you are well aware that the GAO indicated that one of our Achilles' heels is the lack of coordination between Federal agencies. You have at least indicated that there is dialogue and meetings more often now than there previously was. And, Mr. Chairman, I hope that even our Committee could have Governor Ridge back again to at least inform us of the organization structure as it relates to parts of our Committee's jurisdiction, bioterrorism, and the issues that we are dealing with, because I was very concerned about that.
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Public Health and How Clean Is Clean?
Let me indicate my focus will be the local security and the connection to the Federal agencies. Right after September 11, many of us met with our first responders and the meetings were full and they were very vibrant, vocal, and questioning. But one thing we knew is that we had to engage them, rely upon them, and provide them with resources. I would like you to answer the point about our public health system—whether it is teetering, whether we have been able to or are strengthening it, in particular, to be prepared for any onslaught that may occur.
I would also, Dr. Henderson, like to know, do we have enough science in our public and local hospitals to address—we have health—do we have science? Do we have individuals there who have an understanding of what we may be confronting? And then I would like to find out how safe is safe with respect to biowarfare and cleaning up the Hart building? How safe is—how do we know we can go in? And also, how can we really confirm that any random person cannot get anthrax or any sort of bioterrorist type of bacteria? How do we—how can we say for sure that you can't have accesses since we know that some foreign countries have simply called up on the Internet and got it from American companies without any questions and concerns?
Public health, how clean is clean, and how can we make a pronouncement that you cannot get anthrax or any of these others randomly to do danger to our communities?
Chairman BOEHLERT. Dr. Henderson, you will be able to try. The gentlelady's time has expired, but it is a very important question, so we will go to it.
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Dr. HENDERSON. Very good.
Ms. JACKSON LEE. Thank you.
Dr. HENDERSON. With regard to public health, we have let our public health infrastructure lag for a long time. And building it back is going to take time and it is going to take resources. And actually, resources going to state and local health departments have only begun to flow. Really, within the last 18 months, has anything been put in? And actually, the amount that has been provided has been very limited—very limited amounts of money. So I think we have a long way to go and I think we have got to do more and put more in the way of resources in there than we are now because this really is our basic group that is going to respond and orchestrate whatever we want to do with regard to drugs or vaccines, the discovery of the outbreak, or what have you.
Chairman BOEHLERT. Thank you very much.
Ms. JACKSON LEE. Mr. Chairman, would you indulge me. I asked a question about science—in the hospitals, what kind of science professionals we have. And I also asked how safe is safe?
Dr. HENDERSON. Let me take the science. I think you are referring probably to how well equipped the people are to, let us say, diagnose cases and know how to respond. Not very well yet. We have got a—I think a significant educational effort that has to be mounted. We will be developing, I think, a very comprehensive educational package right after the first of the year, and that is a target group that we have, the emergency room people and those who would be seeing patients.
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Ms. JACKSON LEE. If I could get the other questions, Mr. Chairman, answered in writing, I would greatly appreciate it. I know that the time is short.
Chairman BOEHLERT. We will all have an——
Ms. JACKSON LEE. So I would appreciate that very much.
Chairman BOEHLERT [continuing]. Opportunity to ask the distinguished Panel questions in writing and we would——
Ms. JACKSON LEE. Thank you, Mr. Chairman.
Chairman BOEHLERT [continuing]. Appreciate a timely response. And I must admire the skill of the gentlelady from Texas in getting 38 questions into a very brief period of time.
Ms. JACKSON LEE. Such a powerful hearing, Mr. Chairman, and we thank you for your leadership on this.
Chairman BOEHLERT. Yeah. The Chair recognizes Mr. Smith.
Accountability for Anthrax Produced in the U.S.
Mr. SMITH OF MICHIGAN. Thank you, Mr. Chairman. Thanks for the hearing. I hope to acquire some of those talents to expand the questioning time. I might have missed some of your answers earlier. The International Relations Committee is holding a hearing right now on the sources of some of the biological and chemical weapons, and those sources are absolutely Russia and absolutely Iraq, but looking at other sources also.
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To the extent that an ounce of prevention is worth a pound of cure, I have a couple of questions on the ounce part of it. There has been a debate whether the anthrax, for example, was weaponized. But as we analyze the inhalation that came to Capitol Hill and some other areas, the inhalation form of that anthrax, it is easy to conclude that because of the concentration of those anthrax spores that it did have some degree of weaponized sophistication. So that is one question.
But the number of those spores in—the number of those spores that were evident is not as much consistent with our knowledge of what has been produced in Iraq or Russia as it is consistent with the concentration that has been used for weapon development in the United States. So one of my—maybe my first question really is to you, Dr. Johnson-Winegar, that how much do we know in terms of accountability for all our weapons-grades anthrax that has been developed by DOD in the United States?
Dr. JOHNSON-WINEGAR. Sir, in accordance with the treaty and the BWC, the United States has destroyed all of our weapons-grade anthrax material, and we only have small amounts of anthrax that are used for defensive purposes, specifically things, for example, testing new vaccines, testing therapies, or other things like that.
Mr. SMITH OF MICHIGAN. Well, so back up to the destruction—is it true that the concentration—the extraordinary high concentration of the deadly spores is only consistent with the weaponized anthrax that was developed in the United States?
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Dr. JOHNSON-WINEGAR. Sir, I have——
Mr. SMITH OF MICHIGAN. And I don't know who to ask that question to, but I mean, it should concern us. It should maybe stimulate us to really do an investigation of how was it destroyed, how accountable was that destruction, and what is left. Is that—does anybody know the answer, that the concentration of those deadly spores is only consistent with the weaponized production in the United States?
Dr. HENDERSON. Well, let me suggest here, I think the—it is a concentrated product. To say weaponized, I think anybody that is producing anthrax in this form, it is a weapon. There is no question about that. And it——
Mr. SMITH OF MICHIGAN. No. No. But we are talking about the people who can. CIA Director——
Dr. HENDERSON. Right.
Mr. SMITH OF MICHIGAN [continuing]. Testified that though—that bin Laden and his associates have either tried to buy it, including anthrax and other forms of bio and chemical weapons, or they have started developing facilities to develop it themselves.
Dr. HENDERSON. Correct. And the question is, is this domestically produced or is it necessarily international? And I think your question, if I am getting to it, maybe I am not——
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Mr. SMITH OF MICHIGAN. My understanding is that the sophistication and the concentration of the deadly spores is a—it would have to be a weaponized——
Dr. HENDERSON. Yes.
Mr. SMITH OF MICHIGAN [continuing]. System. I mean, developed specifically with the sophistication and scientific knowledge to develop that kind of inhalation anthrax that was evidenced. Is that right?
Dr. HENDERSON. Whoever did it had to know what they were doing. They had to run through not one, but several batches of this to get it to the stage where it is. And could it have been done in the United States? There—it would be difficult, but I think the estimation is it could be done in the United States. Could it be done abroad? Could it come from abroad? The answer is, yes, it could. And I think there are arguments on both sides as to whether it would—which way it could go, and I don't think we really can say for certain at this point in time.
Mr. SMITH OF MICHIGAN. Is DOD re-evaluating, or should we be re-evaluating the destruction and the possible loss of some of that weaponized grade of anthrax that was developed in this country?
Dr. JOHNSON-WINEGAR. I don't believe that we have any efforts ongoing to review those records. But certainly, we are being very vigilant about any of the small amounts of anthrax material that we have available now for our research programs.
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Mr. SMITH OF MICHIGAN. I mean, what concerned me—and I guess that is what I am also trying to ask you—is that a correct analysis that the concentration of those spores that were evidence, that we know about in that mailing, is consistent more with the weaponized grade of anthrax that was developed in this country than other countries? And should that lead us to be more concerned and wary of the disposing of our products?
Dr. JOHNSON-WINEGAR. To the best of my knowledge, the United States did not have the Ames strain of anthrax weaponized. The Ames strain was essentially isolated after the United States destroyed our stockpiles of weaponized anthrax. So to make the leap that it came from a pre-existing stock, I don't believe is a correct assumption.
With regard to the concentration factor, I believe that a number of possibilities exist to improve or increase the concentration. And, as been stated before, there are clearly a number of different countries in which that type of capability exists.
Mr. SMITH OF MICHIGAN. Well——
Chairman BOEHLERT. The gentleman's time has expired.
Mr. SMITH OF MICHIGAN. Yeah.
Chairman BOEHLERT. The patient Mr. Larson.
Mr. LARSON. Thank you very much, Mr. Chairman. And let me join in the chorus of applauding you and Mr. Hall for putting this hearing together, and thank our panelists as well. I do have questions that I would like to submit for the record, along with testimony. But let me start by saying I think Thomas Friedman said it best about September the 11th, that it was a failure of imagination on the part of this Nation to think outside the box.
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And since September 11, as we examine and hear testimony, I was struck by what Dr. Smithson said when she noted before this Committee that of the $8.7 billion currently appropriated to deal with terrorism and the related consequence, 8.4 of it stays within the beltway and only 300 million gets out to our first responders, to the states.
Funding For and Coordination With Local Responders
Dr. Henderson, you have already, in answering Representative Jackson Lee's question, indicated that we need more. These have direct budgetary consequences. And my question to all of you with regard to thinking outside of the box—where do we stand vis-á-vis what is in the budget and what is currently being requested with respect to risk assessment, equipment, training, supplies, all of which have been mentioned, and the kind of—whether or not it is a question of funding, manpower, and coordination, or all three?
It has become clear to us that it wasn't the FBI, the CIA, the FAA, or any Federal agency that responds first to any of these catastrophes. It is our local responders. And in terms of thinking outside of the box, how are you integrating response with our local and state officials?
Dr. HENDERSON. I think the need to develop a close working relationship with state and local officials is absolutely critical. It is—this is really a difficult problem to deal with because we are dealing with a number of health groups who ordinarily don't work that closely together. And I am thinking of private hospitals, for example, and building coalitions and developing plans, the problem of working with FBI, with different needs, in terms of making information available. So that there is a great deal of work to be done here.
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And in terms of manpower, there certainly is a lack of manpower. As I mentioned before, we have had very little of—in knowledge in—and let us say programs in our academic institutions because we are just really beginning now to try to do some training, to get people up to speed, to try to get information out. And there is a lot, a lot to do because there just has not been that body of academic expertise for training and for development for research.
Where the funding has been a problem, I think, in a significant way, in the budget, 2002 budget, which you have acted upon. You have addressed this very significantly. But it is not something we can turn around in just a year. It is going to have to—we are going to have to keep at this year after year to bring, I think, the various resources locally up to speed and move ahead.
Mr. LARSON. I guess that is my question, Dr. Henderson. I understand the need to get after it year after year, but is this death by incrementalism or is this something that the wake-up call of not thinking outside the box should ring loud and clear to all of us—that we haven't made adequate investments in R&D, that we are not prepared. I mean, the whole call of this hearing is, are we prepared? And I think most people in Congress think that we are more aware, but we are not more prepared. And where is that—you know, is this an incremental step or is this something where we need to step up in a big way in terms of the kind of funding that is needed or manpower or coordination?
Dr. HENDERSON. Well, there is a substantial amount of money identified for the 2002 budget. The discussions that are going on now with regard to the 2003 budget are very intensive, indeed, with General Ridge—or Governor Ridge and his group, the Office of Management and Budget. And there really is, I think, a general recognition that resources are a problem that we are going to have to address.
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I think there are problems in how fast you can increase because I think you increase too rapidly, you really can't—you don't spend your money well. And it is the balance of how rapidly can we move and do it well. And I think we are very cognizant of that and trying to see what the balance really is.
Mr. LARSON. The rest of the panelists?
Dr. JOHNSON-WINEGAR. With regard to working with the state and local groups, I totally agree with your comment. As you may or may not be aware, the Department of Defense is currently the co-chair of a group called the Interagency Board where we, along with our Federal partner, the Department of Justice and the FBI, work with a national group of local responders. And that is fire, police, emergency medical technicians, etcetera. And I think that that is certainly a forum for us to provide avenues for looking at ways to transfer some of the technologies, for example, that we have developed in the Department of Defense to them.
And the other point that I would like to mention is that the Department of Defense is working with the civil support teams, which are also the National Guard groups that the Congress directed that we have set up, and they are prepared to interface with the local first responders, again, to facilitate the best exchange of information and technologies.
And the final point that I wanted to make is that we have a number of web-based types of training, which gets to the point that was made earlier, about providing information to people that are in need of it. Clearly, all of those things are ongoing efforts and we are looking at ways to accelerate them and, again, to increase the funding support from the Department of Defense in those areas.
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Mr. LARSON. Ms. Fisher.
Ms. FISHER. Congressman, I would add to that part of the supplemental request that EPA has up here is to provide additional training for the first responders that are going to be on the scene first, as you noted. And, secondly, under the Office of Homeland Security, FEMA has taken the lead on doing an analysis of where the strengths and weaknesses are throughout the country on focusing primarily at first responders and what kind of gaps there are in training. And as part of that, they will be looking at how to address those.
Mr. LARSON. What kind of——
Ms. FISHER. So I think that——
Mr. LARSON. What kind of monies are they going to require for that, do you know?
Ms. FISHER. To do the study or coming out of the study? To do the study——
Mr. LARSON. Both.
Ms. FISHER. Well, to do the study, they are drafting all of us from the Federal agencies that have a role and a responsibility in first response. And dealing, I believe, also with state and local governments. I mean, the people that are involved in that network. And I think from that analysis, they will have an idea of what the budget requirements are.
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Conclusion
Chairman BOEHLERT. Thank you very much. I think it should be obvious to all of you that the number one concern here is coordination. And we want to make certain that there is a coordinated effort and a focal point—and I suppose it is the Office of Homeland Security and your office, Dr. Marburger—so that we know—we have a compilation of all the questions that arise.
Take the anthrax example with the Hart building. We need to collect all the research questions that arise out of those attacks. We need to assign a priority to them. As I said in my opening statement, we need to assign Federal agencies to study them and provide a budget for that activity. And it is important that EPA know what DOD is doing and vice versa. It is important that we get, from the Administration, a request for the resources necessary to make certain this coordinated effort is going forward.
And I think there has been tremendous progress thus far, but we have got a long way to go. This is something we have not experienced before in our history. And I am so pleased to see Dr. Henderson back in the saddle. And, Dr. Marburger, I couldn't be happier that you are where you are. And, Dr. Johnson-Winegar, and, Linda Fisher, two very valuable resources. We are comforted by the fact that you are here as a Panel. We are comforted by the fact that you are all indicating the highest sense of priority of the work you are going about. We just want to make certain you are doing it collectively, there is coordination, there is the focal point. And, quite frankly, this is time when we don't so much concern ourselves with the cost, but we have to concentrate on the cause. And we have to go forward.
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So I thank you all very much for lending us your time and giving generously of your talent. And we will follow up with written submissions to each of you and would ask that you be as timely as you can in your response, which we will share with the entire Committee. With that, let me thank you all very much for your service to the Nation. The hearing is adjourned.
[Whereupon, at 12:50 p.m., the Committee was adjourned.]
Appendix 1:
Answers to Post-Hearing Questions
76416t.eps
ANSWERS TO POST-HEARING QUESTIONS
Responses by Dr. John H. Marburger, III, Director, Office of Science and Technology, Executive Office of the President
Republican Questions for the Record
1. Adequacy of Funding for Bioterrorism R&D:
Q. In your testimony at the December 5 hearing, you estimated that the budget for bioterrorism R&D has been close to $400 million over the past several years.
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a) In deriving this figure, how did you define bioterrorism R&D? Has this definition been used before and will this definition be used in determining bioterrorism R&D funding for the FY03 budget?
The number comes from the OMB database on combating terrorism. The agencies are given a Budget Data Request (BDR) in which all terms are defined, including bioterrorism.
b) GAO has reported (GAO–01–915) that Congress appropriated $150 million to Federal agencies for bioterrorism- and terrorism-related research for fiscal year 2000. Allowing for the fact that GAO did not include in this total any funding allocated to the Department of Defense or the Department of Transportation is your estimate of $400 million consistent with that of GAO? If not, how do you account for the difference?
Yes it is consistent. DOD accounts for roughly half of the bioterrorism R&D.
c) How does the Administration determine the appropriate level of funding for bioterrorism R&D? What role did OSTP play in developing the bioterrorism R&D budget for fiscal year 2003?
The Office of Homeland Security requested that the Federal Agencies and Departments submit proposals for R&D programs addressing the issues posed by the September 11th attacks and subsequent Anthrax mailings. Keeping in mind the need to prioritize those areas for which the U.S. was least well prepared (specifically, bioterrorism), OHS in consultation with OSTP (for judgments on technical issues) and OMB prepared a recommendation for the FY03 Budget.
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With regard to FY04, OSTP has under the NSTC constituted working groups in a variety of anti-terrorism areas. One of these, the Biological and Chemical Preparedness working group, focuses on issues related to bioterrorism. OSTP, in coordination with OMB and the Office of Homeland Security, has been tasked to provide a research agenda for the President in anti-terrorism that will assist the agencies as they prepare their FY 2004 budget submissions. Following that, OSTP will provide advice to OMB throughout the FY 2004 budgeting process to assure consistency between the final budget and the President's guidance.
2. Helping the Private Sector Navigate the Federal Bureaucracy:
Q. You said in your testimony that you are attempting to ''shape a Federal interface'' with the private sector to take advantage of the avalanche of ideas and suggestions that businesses and individuals have offered in the wake of September 11.
a) What specific steps is OSTP taking to help the private sector navigate through the Federal bureaucracy? Is OSTP coordinating or tracking the efforts individual Federal agencies have made in this regard?
b) Will the private sector be provided with a single point of entry into the Federal system? When and by whom?
c) What is the relationship between OSTP and the Technical Support Working Group in efforts to evaluate ideas submitted to the government to combat terrorism?
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(answer a through c) Following the September 11th attacks and subsequent anthrax mailings, virtually every agency in the Federal Government began receiving ideas from individuals, small businesses, and large corporations to assist in the war. OSTP alone received about 70 proposals. The Department of Defense issued a request for such ideas by putting out a Broad Agency Announcement (BAA), which was widely publicized in the press. This BAA garnered approximately 12,500 responses in the form of 1 page descriptions. The review process is being managed by the Technical Support Working Group (TSWG), a multi-agency group dedicated to providing innovative tools for combating terrorism, and co-chaired by the Department of State and Department of Defense. Several of the Federal agencies forwarded proposals they had received to the TSWG where they were cross-referenced for duplication. Those concepts that were not duplicative of papers that the TSWG received in response to the BAA are being evaluated as well.
This process is still evolving; for example, HHS is providing a point of entry for ideas to ensure public health preparedness. OSTP, both internally and in conjunction with other agencies including TSWG, is working to formulate a process whereby citizens can access a single point of entry into the Federal Government (perhaps through a web site) to determine who to contact. OSTP has no funding authority and is not evaluating nor recommending funding for individual proposals.
3. How Clean Is Safe:
Q. During a November 7 Science Committee hearing on decontamination, it became clear that there was no scientific consensus as to how clean after decontamination a building must be before the public could be allowed to safely return. In briefings for staff prior to the December 5 hearing, representatives from Environmental Protection Agency and Centers for Disease Control and Prevention each said that the other agency had primary responsibility for determining the level of decontamination necessary to make a building safe. Recently, however, EPA and CDC apparently shared responsibility in determining that the Senate Hart Office Building was safe.
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a) What role, if any, did OSTP play in determining when it was safe to reopen the Hart building?
b) What steps is OSTP taking to ensure that a clear standard of safety exists in the future?
(answer a, b) OSTP did not play a role in determining when it was safe to reopen the Hart building, other than being briefed on the decontamination process. OSTP is convening interagency meetings to develop protocols for assessing the efficacy a variety of decontamination technologies.
4. Answering Newly Identified Scientific Questions:
Q.: The anthrax attacks exposed many gaps in our knowledge related to bioterrorism. For example, we did not know the minimum number of anthrax spores to which a person had to be exposed to become infected, whether antibiotics or vaccines were the most effective way to treat anthrax victims, and when a decontaminated building was safe.
a) What is OSTP doing to systematically identify gaps in our knowledge and ensure that research to fill those gaps is assigned to specific Federal agencies and adequately funded?
It is certainly true that the anthrax attacks helped to pinpoint gaps in our knowledge base related to detection and identification of infectious agents and highlighted the need for protocols that can be used in the future, whether outbreaks are due to natural causes or deliberate exposure. OSTP is working with Federal research agencies to establish research priorities and to ensure that critical areas are covered. These efforts will facilitate interagency coordination, allowing us to leverage resources and share results.
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b) Is OSTP examining whether research to answer questions related to bioterrorism might conflict with the Nation's obligations under the international bioweapons convention?
The following answer was provided by the Deputy Assistant to the Secretary of Defense (Chemical/Biological Defense). The 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (BWC) states that States Parties are ''never, in any circumstances, to develop, produce, stockpile or otherwise acquire or retain: 1. Microbial or other biological agents or toxins. . .of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.''
The prohibition in the BWC, such as they are, are based on the intent of the user. There are no specific restrictions on research, or production of biological agents. A study in animals to determine a minimum infectious dose of anthrax is not prohibited by the treaty. Such studies are frequently performed during the development of experimental models which are used to test the efficacy of vaccine candidates and therapies. Likewise, preparation of anthrax with which to test protective equipment or other protective measures is not prohibited by the BWC.
5. Identification and Establishment of Research Priorities:
Q.: Dr. Anna Johnson-Winegar testified at the December 5 hearing that the Department of Defense establishes its research and development priorities according to the rankings of biological agents on its ''validated threat list'' compiled by the Defense Intelligence Agency. Dr. Henderson stated at the hearing that HHS also operates from a similar list.
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a) Should civilian agencies share and set priorities according to a single list of biological threats ranked by a civilian agency such as the FBI?
There are a number of human, plant and animal pathogen lists that were constructed for a variety of purposes. Factors considered in placement of pathogens on a list include disease-causing potential; availability of drugs or vaccines to mitigate effects; ability to survive outside a laboratory setting; and, in the case of a ''threat list,'' ease of use of the organism to serve as a bio-warfare agent. One of the most commonly used lists is the ''CDC Select Agent list.'' Its function is to define procedures for handling such organisms so as to maximize public health safety and laboratory security, not to dictate research priorities. However, because inclusion on the list may be the result of absence of satisfactory means to treat or prevent infection with these agents, it follows that such organisms may also be priority targets for research and development efforts.
b) How high a research priority for the Federal Government are biological agents that threaten agriculture, such as foot-and-mouth disease? What steps is OSTP taking to ensure counter-terrorism research at the Department of Agriculture is coordinated with other Federal agencies?
Research to improve rapid and accurate detection, and control emerging or exotic pathogen threats is a high priority for the Federal Government. Recent outbreaks of the highly virulent Newcastle disease of poultry in Australia and Mexico and the recent foot-and-mouth disease outbreak in the United Kingdom have required destruction of high numbers of animals to control these diseases. Immense economic losses due to domestic and international trade embargoes have resulted.
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Disease outbreaks from the malicious introduction of a pathogen like FMD could have profound impacts on the national infrastructure, the domestic economy, and export markets. It would negatively affect consumer confidence in the safety of U.S. products and the government's ability to handle national agricultural disease or toxin emergencies.
OSTP is coordinating research in this area through the NSTC Anti-Terrorism R&D Task Force's Biological and Chemical Preparedness Working Group. In addition, OSTP is a member of the Office of Homeland Security's Food and Agriculture Working Group under the Medical and Public Health Preparedness Policy Coordinating Committee.
6. Effect of Counter-Terrorism Legislation on University Research:
Q.: You attended a session at the National Academy of Sciences on the possibility that recently enacted legislation intended to prevent the misuse of biological agents could hamper important research.
What steps are OSTP taking to determine whether and to what extent research is being constrained by efforts to combat terrorism?
OSTP does not believe that compliance with the provisions of the Patriot Act will impede research and no scientific organization has notified us of such concerns. However, OSTP is mindful of the potential harm that might be caused by measures that unnecessarily restrict the free flow of scientific information or exchange of biological materials. OSTP is engaged in discussion of this important issue with groups in and outside the government, including research funding agencies and scientific societies, including the National Academies.
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Democratic Questions for the Record
1. Adequacy of Agency Budgets for Bioterrorism
a) Do you believe that the Administration's request of $1.5 billion in FY 2002 for bioterrorism is sufficient?
b) The Director of the CDC (Dr. Jeffrey Koplan) and the Director of NIH's Institute of Allergy and Infectious Diseases (Dr. Anthony Fauci) testified to the Senate last week that they believe the figure should be at least $2.8 billion. Do you endorse their estimate of the actual needs? If you do not, please specify what elements of their effort you would not fund at the levels they recommend.
c) Have you had any input into the ongoing negotiations between the Administration and the Congress about the appropriate level of funding for bioterrorism?
(answer a through c) Although I was not yet on board at OSTP when the FY 2002 budget request was developed, I believe it was reasonable, given our perception of risk at that time. It did represent a significant increase over FY 2001. I fully supported the three fold increase requested in the FY 2002 Supplemental request, which was informed by the tragic events of the Fall. It is my expectation that as time goes on, both definitions, and estimates of need, will continue to be refined as vulnerabilities are identified and the costs for addressing them are calculated more precisely.
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The process for developing the FY 2003 request was as follows. The Office of Homeland Security requested that the Federal Agencies and Departments submit proposals for R&D programs that addressed the issues posed by the September 11th attacks and subsequent Anthrax mailings. Keeping in mind the need to prioritize those areas for which the U.S. was least well prepared (specifically bioterrorism), OHS in consultation with OSTP (for judgments on technical issues) and OMB prepared a recommendation for the FY 2003 Budget.
With regard to FY 2004, OSTP has under the NSTC constituted working groups in a variety of anti-terrorism areas. One of these, the Biological and Chemical Preparedness working group, focuses on issues related to bioterrorism. OSTP, in coordination with OMB and the Office of Homeland Security, has been tasked to provide a research agenda for the President in anti-terrorism that will assist the agencies as they prepare their FY 2004 budget submissions. Following that, OSTP will provide advice to OMB throughout the FY 2004 budgeting process to assure consistency between the final budget and the President's guidance.
2. Adequacy of Agency Budgets for Bioterrorism R&D
Q.: Since September 11, there have been many proposals for additional emergency funding to counter bioterrorism. The Administration has a proposal, as do Congressman Obey, the House Democratic Caucus, Chairman Tauzin, and Senator Byrd.
a) You have commissioned the RAND Corporation to provide you with an analysis of Federal R&D programs and budgets related to bioterrorism R&D. Is it fair to say that OSTP is the place to go in the Administration for analysis of the Federal bioterrorism R&D budget?
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RAND has been tasked by OSTP to survey agency R&D activities in the combating terrorism arena; although it is expected that this activity will not provide a complete list of those activities, nor an accurate picture of the budget, it nevertheless should provide insight into the major efforts.
Compare for us the Administration proposal and the various Congressional proposals in terms of the enhancements that they contain in FY 2002 for bioterrorism R&D. To put the question another way, of the $40 billion in supplemental funding allocated in response to 9/11, how much would the President allocate for bioterrorism R&D?
Materials attached describe the allocation of the FY 2002 supplemental appropriation.
b) After 9/11, the various Federal agencies involved in bioterrorism R&D developed lists of R&D projects to be funded as part of the $40 billion supplemental funding. Did you receive and/or review the lists produced by the agencies? Did you push for these proposals with Mitch Daniels, Director of OMB? Did you talk to Daniels about these proposals?
We did not fund R&D projects with the $40 billion because the $40 billion was an ''Emergency Response Fund.'' We tried to fund the high priority projects and programs that either were relief due to the attacks, part of the response to the attacks, or immediate protection against another possible imminent attack.
3. Test-Beds for Promising Technologies
Q.: There are many individuals in the private sector and in Federal labs who probably feel that they have an idea or a technology that could help in some way in the fight against bioterrorism.
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a) Is there a single-point-of-contact in the Federal Government for these individuals?
As outlined in answers to similar Republican question:
Following the September 11th attacks and subsequent anthrax mailings, virtually every agency in the Federal Government began receiving ideas from individuals, small businesses, and large corporations to assist in the war. OSTP alone has received about 70. The Department of Defense issued a request for such ideas by putting out a Broad Agency Announcement (BAA), which was widely publicized in the press. This BAA garnered approximately 12,500 responses in the form of 1 page descriptions. The review process is being managed by the Technical Support Working Group (TSWG), a multi-agency group dedicated to providing innovative tools for combating terrorism, and co-chaired by the Department of State and Department of Defense. Several of the Federal agencies forwarded proposals they had received to the TSWG, where they were cross-referenced for duplication. Those concepts that were not duplicative of papers that the TSWG received in response to the BAA are being evaluated as well.
This process is still evolving; for example, HHS is providing a point of entry for ideas to ensure public health preparedness. OSTP, both internally and in conjunction with other agencies including TSWG is working to formulate a process whereby citizens can through a single point of entry into the Federal Government (perhaps a web site) determine who to contact. OSTP has no funding authority and is not evaluating nor recommending funding for individual proposals.
b) EPA has facilities that enable inventors to test environmental technologies. NIST has many programs to certify both products and other testing labs. Is there a need for a Federal funded facility at which inventors or companies could test and/or certify promising anti-terrorism technologies?
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Anti-terrorism technologies are required to seek approval via customary regulatory channels. Once approved, however, there is likely to be a variety of options available to address specific problems. We hope that attention given to these challenges will result in research and development leading to innovative new technologies, particularly where satisfactory methods do not yet exist. These technologies cover a wide spectrum of applications from sanitization of personal items such as clothing, to detection of unknown biological agents in urban or rural settings, to drug and vaccine development. It is certainly conceivable that the Federal Government would have a role in the evaluation and certification of new anti-terrorism devices and methodologies, whether in a government facility, or other possible mechanisms. This is one of several avenues that merit consideration in order to ensure the availability of successful measures for prevention and mitigation of the effects of terrorist acts.
c) As a more general matter, which agency(s) is in charge of certifying contractors involved in cleanup of bioterrorism hazards? We know that various technologies are being used by private contractors to clean up hot-spots in both House and Senate Office Buildings. Are these technologies formally ''certified'' as safe and effective? If so, by whom? How are contractors selected in these clean-up jobs? Technical qualifications? Lowest bid?
OSTP has convened expert groups to assess the adequacy of technologies that have been applied to novel problems, such as sterilization of personal effects removed from the Hart Senate Office Building. In this case, agency officials responsible for regulation of sterilization methods for other purposes pooled expertise to establish conditions appropriate to this task. These conditions were set to meet a high confidence level that may be more stringent than necessary. These conditions will be tested and reviewed, leading to better refinement over time.
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The Environmental Protection Agency, at the request of the Sergeant-At-Arms, took charge of the decontamination procedures, employing procurement mechanisms available to the agency, including contracts. I would refer you to EPA for more detailed responses about its procurement practices.
4. How Many Spores Are Required to Infect a Person?
Q.: At the December 5 hearing, Dr. Henderson addressed the question of how many anthrax spores it takes to cause inhalation anthrax.
a) How would do you determine how many spores are needed to cause illness?
Customarily, animal studies and historical evidence would be used to make such a determination. In the case of anthrax, specialized containment facilities are necessary to conduct new studies and this is under consideration. However, even with such studies, a degree of uncertainty with respect to extrapolation to a broad human population would remain.
b) Have their been any discussions of conducting animal studies (the most reliable method for establishing dose exposure rates) to better understand this question?
Yes.
c) We have heard that animal research could be construed as being part of an offensive biological weapons program. Do you agree? Would DOD be able to conduct animal studies to answer these critical questions? Would HHS? Would the State Department and other Federal Departments need to be consulted?
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The following answer was provided by the Deputy Assistant to the Secretary of Defense (Chemical/Biological Defense). The 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (BWC) states that States Parties are ''never, in any circumstances, to develop, produce, stockpile or otherwise acquire or retain: 1. Microbial or other biological agents or toxins of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.''
The prohibition in the BWC, such as they are, are based on the intent of the user. There are no specific restrictions on research, or production of biological agents. A study in animals to determine a minimum infectious dose of anthrax is not prohibited by the treaty. Such studies are frequently performed during the development of experimental models which are used to test the efficacy of vaccine candidates and therapies. Likewise, preparation of anthrax with which to test protective equipment or other protective measures is not prohibited by the BWC.
5. DNA Fingerprinting Pathogens and National Sequencing Priorities
Q.: DNA fingerprinting is being used to identify anthrax strains. Is it a goal of the USG to use this technology to determine definitively the source of the anthrax used in the recent attacks?
Several technologies, including DNA fingerprinting and genome sequencing, will provide information useful to law enforcement officials in identifying the source of the bacteria used in the recent attacks through the postal system. It is our express intent to identify and obtain the best foundation of knowledge about human, animal and plant pathogens to support the development of diagnostics, detectors, decontaminating methods, drugs and vaccines needed to ensure public health and safety.
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Q.: Last year, the Congress provided significant funding for anti-terrorism R&D, mostly in the area of bioterrorism countermeasures. Can you comment on how that funding is being spent today?
Agencies across the government are engaged in research to bolster our ability to detect and mitigate the effects of disease-causing microorganisms, whether they are produced as a result of a natural outbreak or an act of bioterrorism. For example, USDA research includes measures to identify and prevent infectious diseases among species of economic significance, as well as food supply contamination. The principal loci for human infectious diseases are DOD and HHS DOD's R&D efforts are focused on methods for rapid detection of biological agents, outbreak surveillance systems, technology and tactics of bioterrorists, and countermeasures to the use of biological agents. HHS funds basic research on human, plant and animal pathogens; their structure and mechanisms of action; and targets for diagnostics, drugs and vaccines to prevent and treat infections. More applied research includes advancing the field of vaccine development. HHS also supports research and procedures to enhance the safety of the food supply. DOE has played a significant role in development of biosensor technology, as well as microbial genome sequencing.
Q.: DOE has done significant work on sequencing the anthrax genome. Late last year NSF let a sole source contract to do the same thing. NIH is also doing gene sequencing on the Ames strain of Anthrax. Please address the apparent redundancy in sequencing efforts and the need for it. Also, given the increased threat of biological terrorist attacks, should the national DNA sequencing priorities be reevaluated?
There is no single Bacillus anthracis genome. There are over a hundred strains of B. anthracis, including Ames. Even within a strain, each new isolate has subtle differences in its genome. Sequencing can be done for different purposes, each having different requirements for accuracy or completion. A sequence-based diagnostic or biosensor can be used to identify B. anthracis but gives no information that could be used for forensic purposes. For example, when B. anthracis appeared in the mail, it was possible to determine that it was Ames, based on existing sequence information, as well as other analytical methods. However, even though B. anthracis seems to have little genetic variation compared to some microorganisms, further sequencing is necessary to provide definitive linkage to a source.
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Discussion of microbial pathogen genome sequencing needs and priorities is under way using the resources of an interagency group that operates under the aegis of the National Science and Technology Council. The B. anthracis experience is useful in reflecting on what sequence data need to be in place to support development of countermeasures, and what would need to be carried out in the event of another bioterrorist attack. Agencies are coordinating their efforts to fill gaps identified through this process and to avoid unnecessary duplication.
Based on recommendations from the NSTC Microbe Project, NSF awarded a merit-based grant to The Institute for Genomic Research to sequence the Ames strain of B. anthracis found to have contaminated the building in Florida in October. Sequencing the Florida isolate was important from a law enforcement perspective, to get information that would, hopefully, identify its source. This was a virulent strain that was not the same as the sample sequenced previously by TIGR, funded by DOE. The sample sequenced earlier had been ''cured'' of the plasmids conferring virulence.
Q.: NIH, DOE, DOD, NSF, and USDA all fund DNA sequencing projects. Should a broad multi-agency sequencing group be created to plan the sequencing and derivation of genetic markers for potential bio-warfare pathogens? If so, who would coordinate and lead this group? OSTP?
The NSTC Microbe Project is assisting in the development of priorities for pathogen genome sequencing. Other groups, such as law enforcement and intelligence community representatives, as well as the broader scientific community, will contribute to the establishment of these priorities.
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a) The anthrax genome apparently had been available to the public through GenBank or another DNA sequence database. Is that correct? Is it still available?
In 1999, NIH, DOE and the DOD Office of Naval Research, provided funding to the Institute for Genomic Research to sequence the genome of one strain of Bacillus anthracis. This is nearly complete and is not posted on GenBank. Other efforts have produced the sequence of specific genes or regions of the genome of various B. anthracis isolates. Some of these are posted on GenBank.
b) Discuss the tradeoffs involved in making genetic information widely available through a public database. We refer to the possible use of such information by our enemies versus the vital research (on tools to combat the pathogen) that broad disclosure may enable.
It is the policy of NIH and other government agencies to require grantees to post sequence data on GenBank or other publicly available databases. Whether sequence data, in the absence of further analysis, offers significant information that might be used against us is an open question. How to draw the line that both protects against the loss of sensitive information while allowing vital research to proceed is a delicate balancing act. One element that should be considered is the relative ease of obtaining certain data, including sequence, in the context of the need to make such data available to legitimate researchers. OSTP is soliciting the views of the broad scientific community, including the National Academies, to determine the best way to draw this line. It is a serious question that demands our most focused attention.
6. Questions on Status and Reorganization of OSTP
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a) You took your job with the title of ''Director'' of OSTP. You did not get the traditional title of ''Special Assistant to the President.'' Why didn't you insist on keeping the title of ''Special Assistant'' or take ''Assistant to the President'' as Dr. Rice has?
I have never been fixated on titles, and I accepted the position here as Director of OSTP. The difference in the title has had absolutely no bearing on my ability to carry out the functions of this office.
b) Do you have direct, unimpeded access to the President?
The President calls on me to provide scientific input for decisions where he feels independent advice based on sound science principles will help him make better policy decisions. I have had direct access to the President for such situations.
c) Can you speak for the President with agencies in the same way that Governor Ridge or Dr. Rice can?
Yes.
d) Your predecessor had four Assistant Directors: science, technology, environment, and national security & international affairs. You do not intend to have assistants for environment or national security. The decision not to fill the national security slot has struck many as particularly odd in light of the war against terrorism. Please explain this organizational decision?
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I have organized the office with the goal of reducing stove pipes and enhancing core-disciplinary interaction. Included in the top priorities of this office are global climate change research and anti-terrorism research and development. These have my personal attention and I have a number of top caliber scientists in the office working on these issues. I am confident these issues will receive high priority under the current organization.
7. Lab Security Changes
a) Historically, our great concern with labs that work on materials that could become biological agents in a terrorist attack has been with safety in the lab, not security. Since September 11, CDC has posted a list of steps that labs should take to make themselves more secure. What do we need to do to make sure that we know who has access to these labs and secure the materials worked on in these labs?
It is clear that steps must be taken to enhance laboratory security, thus enabling research that is critical to public health to proceed. Certain steps such as prohibiting access to select agents by restricted persons were included in the Patriot Act, but additional protections, such as those in pending legislation, are needed.
b) Are the voluntary guidelines posted by CDC adequate? When it comes to public safety we have stringent regulatory requirements. What steps should HHS contemplate to turn these recommendations into requirements? Does OSTP have a view on this?
Education about and adherence to the CDC guidelines are a valuable means for ensuring both the safe and secure handling of microorganisms, so that research and development of means to counter infectious disease may advance. This issue is under discussion in a number of fora, including professional and scientific societies and OSTP is involved in the consideration of a variety of options for enhancing laboratory security and safety practices.
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c) Many of the students who work in labs around the country are foreign students on one kind of visa or another. Should we track students' enrollment more carefully, conduct greater background checks, and/or limit the scope of their research?
d) What sort of records are currently kept in the typical university lab working with potential bioweapons materials and for how long are those records kept? For example, if a researcher at a major state University did work on a strain of anthrax 15 years ago, what do we know about what happened to the samples? Do we have a rigorous accounting for that material? Do we have a good record of who worked in those labs? Do we know that only graduate students or fellows assisting the researcher had access to the materials or is it possible others might have wandered in and out of the lab doing other duties?
e) All that being said, how can we make labs secure without losing the free exchange of information that stimulates creativity and breakthroughs?
(answer to c, d and e) These are important questions whose solutions carry serious ramifications for the conduct of research that is vital to homeland security. OSTP has engaged the scientific community, via professional societies including the National Academies, and will continue to pursue policy options that offer benefits in excess of the risks posed by the traditional open culture of science that has served us so well. Certain aspects are likely to be resolved through legislation currently working its way through Congress. We look forward to a dialogue on these points, with Congress, as well as with the scientific community to achieve a result that offers the greatest protection over the long term.
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8. Threat Assessment and Research Priorities
a) Discuss the process by which the Federal Government assesses bioterrorism threats and explain how this analysis feeds back into civilian agency research priorities.
b) What role does OSTP play in coordinating threat assessment information with cross-agency research initiatives?
(answer a, b) The Biological and Chemical Preparedness Working Group under the NSTC Anti-terrorism R&D Task Force is comprised of representatives from civilian and defense agencies. This offers the opportunity to incorporate threat assessments into the development of a research and development agenda for all relevant federal agencies.
Questions for the Record From Representative Jackson Lee
1. How Clean Is Safe?
Q.: After a bio-contaminated building has been disinfected. . .
a) How is it determined that the building is safe to re-enter?
b) Who makes this determination? Is it EPA or CDC? What effort has your office made to understand this dispute and resolve it?
c) Governor Whitman has testified that EPA's cleanup goal is ''zero spores.'' Some believe that zero is an impossible goal because it is unverifiable. Do you agree?
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d) What should the goal be? What should the standard be?
(answer to a through d) Because anthrax does occur in nature, meeting the goal of ''zero spores'' is somewhat unrealistic and would be difficult to verify, as you suggest. However, because we do not know the minimum infectious dose, and it could, in theory, be one spore, it is prudent to use decontamination methods that are known to be effective under the specified conditions, that is, able to penetrate materials present in the contaminated area, that the area can be sealed so as to reach specified levels of humidity, temperature and concentration of decontaminating agent.
It is up to the regulatory agencies, probably CDC, to identify the goal and EPA to implement it. But this will have to be worked out, based on their respective regulatory authorities. Historically, the two agencies share jurisdiction over agent identification, hazard detection and reduction, and decontamination. Otherwise, the agency responsibilities diverge, with HHS focusing on health and medical support issues and EPA given the responsibility of environmental cleanup and long-term site restoration.
e) There will clearly be a need to monitor building occupants after they reenter a previously contaminated building. How should the monitoring be done, and who should be responsible for doing it?
This is customarily the responsibility of NIOSH and OSHA to establish and oversee standards of workplace health and safety.
2. Access to Anthrax and Other Potential Bio-warfare Agents
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Q.: There have been reports in the Washington Post regarding access to anthrax and plague through the American Type Culture Collection (ATCC). The ATCC is a biological resource center that provides microorganisms of all kinds to researchers worldwide—including (at least historically) dangerous pathogens. Apparently, Iraq was able to obtain seven strains of Anthrax from the ATCC in 1988.
a) What has been done to tighten restrictions on the ATCC since those 1988 anthrax shipments to Iraq?
ATCC stopped shipping select agents in 1997, with very limited exceptions for specific government agencies. When ATCC moved to its current location in 1998, its facilities were designed so as to maximize security. In addition, ATCC has had in place a program of continuous security audits by state, local and federal authorities that have judged the facilities their standards.
b) Is there any chance that ''researchers'' may have obtained access to smallpox in the past in a similar fashion?
It is my understanding that smallpox is maintained only at CDC and not ATCC so this scenario appears to be unlikely. ATCC transferred its smallpox to CDC in 1979. In 1994, ATCC transferred to CDC all biological agents whose handling requires Biosafety Level 4 facilities and procedures.
c) Have any additional limits or security checks been put in place since October?
Yes: Initial handling of incoming mail was relocated outside the facility; the building ventilation system was enhanced; the periphery security was increased; criminal background checks were enhanced to include all ATCC employees; and ATCC underwent external inspections by government agencies.
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Can the American public be assured that dangerous pathogens are not freely available and that efforts are made to verify that those who seek samples have a legitimate purpose?
In 1996, the CDC issued a Notice of Proposed Rule Making to implement P.L. 104–132, ''The Anti-terrorism and Effective Death Penalty Act of 1996,'' which requires the Secretary, DHHS to regulate the transfer of select agents. These regulations went into effect in April 1997, requiring facilities that transfer or receive specified pathogens to be registered and to handle these agents in a prescribed manner. The Patriot Act prohibits restricted persons from possession of select agents. I think this system has provided a needed measure of security in terms of registering facilities but that more needs to be done to cover possession of specific pathogens and toxins. We look forward to seeing the legislation covering these important issues when it comes out of conference.
Questions for the Record to Dr. Johnson-Winegar (a & b) and Dr. Marburger (c, d & e), Ms. Fisher (c, d & e) from Representative Rivers
Q.: I represent Ann Arbor, Michigan, home to NanoBio Corporation. With the support of DARPA, they have developed a nano-emulsion decontaminant that is effective for a variety of bioterrorist agents, including anthrax. When they approached the DOD to offer their product as a resource during the anthrax attacks of last month, NanoBio was told that, while their product appears to be an effective decontaminant against biological agents, since it was not also effective against chemical ones they were not interested. I am troubled by this conclusion, as it would seem they're throwing out the baby with the bathwater.
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a) Why is the DOD willing to turn away what could be promising, ''off the shelf'' technologies at a time when there's no set guidelines to follow and when it's clear that we're writing the book on anthrax decontamination as we go?
b) Why is this ''dual purpose'' requirement a reasonable expectation?
c) Again, regarding NanoBio's nano-emulsion, what resources are available to help private companies develop promising technologies that can be of assistance in our nation's escalating focus on bioterrorism?
(answer to a through c) Following the September 11th attacks and subsequent anthrax mailings, virtually every agency in the Federal Government began receiving ideas from individuals, small businesses, and large corporations to assist in the war. OSTP alone has received about 70. The Department of Defense issued a request for such ideas by putting out a Broad Agency Announcement (BAA), which was widely publicized in the press. This BAA garnered approximately 12,500 responses in the form of 1 page descriptions. The review process is being managed by the Technical Support Working Group (TSWG), a multi-agency group dedicated to providing innovative tools for combating terrorism, and co-chaired by the Department of State and Department of Defense. Several of the Federal agencies forwarded proposals they had received to the TSWG where they were cross-referenced for duplication. Those concepts that were not duplicative of papers that the TSWG received in response to the BAA are being evaluated as well.
This process is still evolving; for example, HHS is providing a point of entry for ideas to ensure public health preparedness. OSTP, both internally and in conjunction with other agencies including TSWG is working to formulate a process whereby citizens can through a single point of entry into the Federal Government (perhaps a web site) determine who to contact. OSTP has no funding authority and is not evaluating nor recommending funding for individual proposals.
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d) Are there avenues available for expedited testing and approval of such products?
Discussion of possible options for expedited testing and approval is under way, as well as exploration of existing authorities for conducting expedited regulatory review.
e) In NanoBio's case, upon presenting their product to the EPA, they were told that they needed to reconfigure the product using substances in the EPA's formulary. Are there loans or other forms of financing available to help these companies in the short-term to meet the regulatory requirements?
(answer to d and e) OSTP is not in a position to know about financing tools to help companies meet regulatory requirements. We would encourage such companies to pursue funding for research and development through the mechanisms described earlier, including TSWG.
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ANSWERS TO POST-HEARING QUESTIONS
Responses by Dr. Anna Johnson-Winegar, Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense, Department of Defense; questions posed by Representative Rivers.
Question 1
LIMITATIONS OF THE BIOWEAPONS TREATY ON RESEARCH
Q.: In a briefing for Committee staff prior to the December 5 hearing, you said that the 1972 Biological Weapons Treaty prevented the DOD from conducting research to determine the minimum number of spores of anthrax necessary to cause infection. Yet the New York Times reported on December 13 that U.S. Army scientists admitted to having made gram-quantities of anthrax in the last several years in a powdered form that could be used as a weapon.
Can you clarify what kinds of experiments and activities that 1972 treaty allows and prohibits and why experiments to determine a minimum infectious dose for anthrax might be construed to violate the treaty while making gram-quantities of powdered anthrax would not?
The 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (BWC) states that States Parties are ''never, in any circumstances, to develop, produce, stockpile or otherwise acquire or retain: 1. Microbial or other biological agents or toxins of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes.''
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The prohibitions in the BWC, such as they are, are based on the intent of the user. There are no specific restrictions on research, or production of biological agents. A study in animals to determine a minimum infectious dose of anthrax is not prohibited by the treaty. Such studies are frequently performed during the development of experimental models which are used to test the efficacy of vaccine candidates and therapies. Likewise, preparation of anthrax with which to test protective equipment or other protective measures is not prohibited by the BWC.
Question 2a &b
PROTECTION OF PEOPLE REENTERING DECONTAMINATED BUILDINGS
Q.: You mentioned that personnel who work in areas of Ft. Detrick in which biological agents are handled participate in a voluntary immunization program.
Are personnel who choose not to participate in the immunization program allowed to work in areas where biological agents might be present? Are they allowed to work in areas where biological agents might be present? Are they allowed to work in research areas that may have been contaminated but were later cleaned up?
No. Although the receipt of an investigational vaccine is voluntary, research personnel may not work routinely in research facilities where such vaccines are recommended if they chose to not participate in the voluntary Special Immunization Program. Periodically, biocontainment laboratories are decontaminated using approved procedures with formaldehyde gas in order to perform routine maintenance. Decontamination is verified using microbiological testing. Following such decontamination, it is safe for anyone, immunized or not, to enter these laboratories.
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Q.: In cases in which DOD personnel have returned to work in previously contaminated areas that have been decontaminated does DOD conduct any type of special or more frequent medical monitoring for signs of sickness?
All employees are subject to monitoring under the routine occupational health program, which tailors assessments to the employee's work situation. Because decontamination of a work area is verified by microbiological testing, once an area has been decontaminated, there is no need for any special or additional surveillance of employees who work in that area.
Question 3
NanoBio Corporation—''Off-the-Shelf'' Technologies
Q.: I represent Ann Arbor, Michigan, home to NanoBio Corporation. With the support of DARPA, they have developed a nano-emulsion decontaminant that is effective for a variety of bioterrorist agents, including anthrax. When they approached the DOD to offer their product as a resource during the anthrax attacks of last month, NanoBio was told that, while their product appears to be an effective decontaminant against biological agents, since it was not also effective against chemical ones they were not interested. I am troubled by this conclusion, as it would seem they're throwing out the baby with the bathwater.
Why is the DOD willing to turn away what could be promising, ''off-the-shelf'' technologies at a time when there's no set guidelines to follow and when it's clear that we're writing the book on anthrax decontamination as we go?
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The DOD Chemical-Biological Defense Program (CBDP) has set guidelines and objectives to evaluate technologies to meet the warfighter operational needs and requirements on the battlefield. These requirements are defined in Joint Operational Requirements Documents and in the Joint Future Operational Capability statements. These documents provide insight into the performance specifications that are required to have a product of military utility and, consequently, provide requirements as to the targets of action for decontaminants. The CB Defense Program continues to review and evaluate emerging technologies and off-the-shelf systems to fulfill capability shortfalls. There is an existing process for inserting a commercial/off-the-shelf item directly into a developmental program. Usually during each phase of the acquisition process a Request for Proposal is released to identify systems that will potentially fulfill specific requirements. Incorporating an off-the-shelf item into an acquisition program is actually preferred in order to reduce developmental costs and logistics.
Again, the military is focused upon returning their equipment to operational use to continue the warfighting mission. As such, new technologies and off-the-shelf systems are evaluated against battlefield requirements. Nano-emulsion systems have been evaluated by DOD but have not been inserted into the CB Defense Program due to the extended contact time needed to reduce the military challenge level of spore concentration to a better than acceptable level of residual. Its contact time exceeds all currently documented military requirements. The technology down select process for the Restoration of Operations (RestOps) Advanced Concept Technology Demonstration also required a decontaminate that could effectively neutralize and remove chemical contamination as well as biological contaminants. The nano-emulsion decontaminant has possible utility as a skin and wound decontaminant. Nano-emulsion systems continue to be a potential candidate for the Joint Service Family of Decontaminant Systems (JSFDS) Block III acquisition for personnel decontaminants. Details of the JSFDS RFP for a decontaminant can be found on the U.S. Marine Corp website at: www.marcorsyscom.usmc.mil/Doing Business with Syscom/Opportunities/Joint Family of Decontamination Systems. Both the non-medical and medical programs are aware of the nano-emulsion system and it's potential uses.
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The nano-emulsion approach appears to have more utility as a post-conflict or remediation decontaminant for BW particularly in the clean up of facilities such as the Hart Senate Building. The decontamination of the Senate office suite which contained sensitive equipment, papers and cultural artifacts was a first time event. As such, the Federal Government was ''writing the book on anthrax decontamination as we go.'' However, the decontamination requirements for DOD military operations are better defined. Current versions of DOD CB military requirement documents do not include a requirement to perform decontamination of buildings and facilities.
In light of the events of September, requirements are being re-examined and new mission requirements may be added or become even better defined. As the technology matures nano-emulsion systems may continue to be evaluated against medical and nonmedical biological warfare decontamination needs.
Question 4
NanoBio Corporation—''Dual Purpose'' Requirement
Q.: I represent Ann Arbor, Michigan, home to NanoBio Corporation. With the support of DARPA, they have developed a nano-emulsion decontaminant that is effective for a variety of bioterrorist agents, including anthrax. When they approached the DOD to offer their product as a resource during the anthrax attacks of last month, NanoBio was told that, while their product appears to be an effective decontaminant against biological agents, since it was not also effective against chemical ones they were not interested. I am troubled by this conclusion, as it would seem they're throwing out the baby with the bathwater.
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Why is this ''dual purpose'' requirement a reasonable expectation?
The dual-purpose requirement is a reasonable expectation. The requirement reflects the need of the warfighter to respond while on the move to either a chemical or biological incident. In a tactical military context, the dual purpose requirement is desired to minimize logistics and costs. There are commercial and military products available that effectively perform both chemical and biological decontamination. Currently fielded decontaminants, especially the bleach-based systems, are effective. Systems based on peroxides also can be effective on both chemical and biological agents. These approaches have the benefit of being very rapid in action.
ANSWERS TO POST-HEARING QUESTIONS
Responses by Linda Fisher, Deputy Administrator of the U.S. Environmental Protection Agency
Q. 1. In the wake of September 11, numerous agencies have been flooded with ideas from the private sector to help our nation fight terrorism. In your testimony at the December 5 hearing, you stated that EPA was attempting to provide user friendly interface with the private sector to deal with the influx of these ideas.
a) What steps has EPA taken to deal systematically with these calls?
Answer: EPA's Technology Innovation Office is leading an effort to collect and disseminate information about technologies to detect and decontaminate biological agents. We have established a website — ''Technology for Biological Threats'' http://EPATechBiT.org as a clearinghouse for information about these technologies and their vendors, and links to other resources pertaining to the detection and decontamination of biological agents. This website also helps vendors start the application process to have their antimicrobial pesticide product reviewed and registered in accordance with the Federal Insecticide, Fungicide and Rodenticide Act. We are operating a vendor helpline at (703) 390–0701 and an e-mail address at EPATechBiT@ttemi.com to field inquiries from vendors of detection, decontamination, and measurement technologies. EPA's on-scene coordinators, emergency response personnel, and their contractors who are responding to incidents involving biological agents receive up to date information on new products and vendors collected by the hotline on a weekly basis.
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b) To what degree does EPA coordinate with other agencies of the Federal Government dealing with the private sector? How does EPA handle calls that should be referred to other agencies?
Answer: EPA is working closely with the Interagency Group on Terrorism's Technical Support Working Group (TSWG), jointly chaired by the Departments of State, Defense and Justice, to develop a formal process for selecting and approving new technologies for dealing with terrorism. The Department of Defense recently issued a Broad Agency Announcement for technologies that support the Federal Government's counter-terrorism efforts, to help identify promising new approaches for decontamination, and detection of biological threats. In addition, EPA is working directly with TSWG to review promising new antimicrobial devices and detection technologies from vendors that have contacted EPA's Vendor Helpline. Much of the expertise to evaluate these innovative technical approaches resides in other agencies. TSWG is providing access to national experts to review and assess vendor claims. When calls come in to our hotlines or employees that are best answered by other Agencies, we routinely refer them to contacts or hotlines in the other agencies.
Q. 2. During a November 7, 2001, Science Committee hearing on decontamination, it became clear that there was no scientific consensus as to how clean after decontamination a building must be before the public could be allowed to safely return. In briefings for staff prior to the December 5 hearing, representatives from Environmental Protection Agency and Centers for Disease Control and Prevention each said that the other agency had primary responsibility for determining the level of decontamination necessary to make a building safe. Recently, however, EPA and CDC apparently shared responsibility in determining that the Senate Hart Office Building was safe.
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a) Has a safety level for anthrax been determined? If not, how did EPA and CDC determine that the Hart building was safe to reopen?
Answer: The goal set by CDC and concurred with by EPA was zero detectable viable Bacillus anthracis (Ba) spores for the response at the Capitol Hill Anthrax Site. Using the best available technology to detect Ba, EPA adhered to this goal during the clean-up of the site. The National Institute of Occupational Safety and Health (NIOSH), EPA, the U.S. Army Center for Health Promotion and Preventive Medicine (CHPPM), and other federal agencies convened a special peer group to review the assessment sampling, clean-up and subsequent confirmation sampling. When this group was satisfied that the most comprehensive and appropriate clean-up effort had been performed and all analytical data indicated that no detectable Ba spores could be found, the group signed a release document issued to the Capitol Police Board attesting to the aforementioned condition. In addition, to assure that no Ba spores would remain in areas where they were detected, all fabric and porous like materials were removed for disposal.
b) What was each agency's role in this decision, and were these roles codified in any kind of written agreement between the two agencies?
Answer: As described above, CDC's primary role was to establish the safety level, and EPA's primary role was to oversee the clean-up. The only written agreement is the above mentioned release document issued to the Capitol Police Board.
c) Is it EPA's intent that CDC and EPA will continue to share responsibility in the future for making determinations regarding the safety of decontaminated buildings?
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Answer: Determining the criteria for safe re-occupancy of previously contaminated environments should be a collaborative effort among all the agencies who have expertise in this area, as well as the entity managing the structure and its occupants. For example, EPA is part of a National Coordination Council to assist the U.S. Postal Service (USPS) in their continuing assessment and remediation efforts. This interagency group provides a forum for EPA, USPS, CDC, OSHA and the U.S. Coast Guard to stay current on any progress made in understanding how to deal with anthrax contaminated sites. In addition, the National Response Team has assembled a Technical Assistance Document, which is now undergoing final interagency review. This document will be regularly updated as new technology and research improves our ability to manage the consequences of bioterrorism.
ANSWERS TO POST-HEARING QUESTIONS
Responses by Dr. Donald A. Henderson, Director, Office of Public Health Preparedness, Department of Health and Human Services
1) Has a safety level for anthrax been determined? If not, how did EPA & CDC determine that the Hart building was safe to reopen?
A safe level for anthrax has not been determined for many reasons. First, we do not know how many spores are needed to cause infection in humans. In addition, we are still learning about the behavior of spores in indoor environments (e.g., ability to be re-aerosolized) and about the effectiveness of different ways to detect these spores.
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For these reasons, CDC/ATSDR and EPA jointly concluded that the only feasible approach to evaluate the Capitol office buildings was to use a criterion of no viable spores detected (i.e., zero detectable). To verify that no viable spores were present, a thorough and comprehensive post-remediation sampling protocol was used that included surface sampling and, when deemed appropriate, air sampling (in some instances ''aggressive''). To implement this approach, EPA and CDC/ATSDR worked together via a ''Review Working Group'' (RWG) to review the available environmental data and develop an approach for making an objective determination, based on the above criterion, that the building could be released for re-occupancy. For example, surface samples were taken on all previously contaminated and remediated surfaces to verify that they were acceptably clean. If rooms were contaminated by factors other than secondary (cross) contamination alone, they were tested further using aggressive air sampling. Finally, once these rooms were cleared, additional air samples were taken during start-up of a contaminated and remediated heating, ventilating and air conditioning (HVAC) system. Air samples were taken across all suites serviced by this particular HVAC system, followed by final surface sampling of the HVAC filters to identify any B. anthrax spores. Upon passing this sequence of tests, the workgroup concluded that the building was successfully remediated and recommended that it be turned over to the Architect of the Capitol to ready it for re-occupancy.
2) What was each agency's role in this decision, and were these roles codified in any written agreement between the two agencies?
These were joint decisions involving staff scientists (members of the RWG) from each agency reviewing the cleanup strategies and all sampling data collected both before and after cleanup. These scientists were backed by additional support and review from senior staff at their respective agencies. There was no explicit demarcation of roles by agency, and no written agreement that formalized such. In practice, EPA took a lead role on technical issues describing the various approaches used in the remediation project, and describing and performing characterization sampling (determining the extent of contamination to guide clean-up) and verification sampling (determining whether remediation was effective) done in conjunction with the clean-up. CDC/ATSDR provided a lead role on health issues, on criteria for determining the types of areas needing air sampling and how best to perform it, and provided engineering input on testing of the HVAC system. The roles and decisions reached jointly by the group were codified in the respective Office Building Release Recommendations signed in January 2002. These recommendations accompanied a letter signed jointly by senior EPA and CDC/ATSDR officials.
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3) Is it the intent HHS that CDC and EPA will continue to share responsibility in the future for making determinations regarding the safety of decontaminated buildings?
While it is likely that CDC/ATSDR and EPA will participate jointly in future determinations regarding the safety of decontaminated buildings, their participation may not always be necessary or exclusive. Note that the EPA has primary responsibility for environmental sampling and cleanup, but the HHS has the responsibility to identify, evaluate and control health risks. (see response to question #4)
4) Is it the CDCs responsibility to set a safety standard for clean buildings? If you do not believe it is their responsibility, please point to the authorities in writing that clarify the CDC's roles versus EPA's roles.
Neither agency has a clear and unique responsibility, to set safety standards for clean buildings. They are supposed to consult with each other while carrying out complementary response roles. The responsibilities of EPA and HHS are described in the Federal Response Plan Terrorism Incident Annex (April 1999).
For HHS:
''The HHS plan response may include threat assessment, consultation, agent identification, epidemiological investigation; hazard detection and reduction, decontamination, public health support, medical support, and pharmaceutical support operations.''
For EPA:
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''The NCP [National Contingency Plan] response may include threat assessment, consultation, agent identification, hazard detection and reduction, environmental monitoring, decontamination, and long-term site restoration (environmental cleanup) operations.''
This suggests that the two agencies share jurisdiction over agent identification, hazard detection and reduction, and decontamination, (although the intent may have been for HHS to oversee decontamination of humans and EPA that of property). Otherwise, the agency responsibilities diverge, with HHS focusing on health and medical support issues and EPA given the responsibility of environmental cleanup and long-term site restoration.
5) In the event of a widespread bioterrorist attack, how would the NPS be divided? Would the federal agencies be able to subsidize resources (i.e., linens, tongue depressors, IV fluids) in an area lacking an emergency response plan? Combine all of these comments into 1 paragraph so that it is consistent with the formatting on the rest of the document.
CDC will deliver and transfer NPS materiel to the state and/or local authorities. State and/or local authorities will then distribute the materiel in accordance to their state biological and chemical terrorism contingency plan.
The NPS materiel can be divided by need or category. Oral medications can be pulled and sent to dispensing sites, while medical-surgical supplies and be pulled to go directly to hospitals or treatment facilities.
The NPS can utilize its existing acquisition system to deliver items that are not normally part of the NPS formulary if they are available.
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6) Your agencies met together to discuss bioterrorism preparedness. Have these meetings involved any state or local agencies? Have there been any communications between your agencies and state offices of emergency management or hospitals?
The new HHS Bioterrorism Preparedness program is a rapidly developing work in process, which requires frequent communication among Federal, state and local partners. In January we received 2.9 billion dollars in supplemental funding for public health preparedness. On February 18, we awarded 20 percent of the funds for state and local public health preparedness, and issued instructional guidelines for how to develop their bioterrorism preparedness work plans.
On February 25, during the National Governor's Association Meeting, we invited Governor's staffers, as well as state and local health department officials, to HHS headquarters. During this meeting information about emergency preparedness programs was presented by FEMA, and the Department of Justice. OHS presented the new bioterrorism preparedness initiatives ongoing at the CDC, HRSA and the OEP.
The Office of Public Health Preparedness (OPHP) has sponsored four regional workshops between Feb. 27–Mar. 7 to address questions and issues from state and local health officials and hospital associations. These meetings were designed to clarify supplemental funding guidelines and to provide technical assistance as needed. Since these workshops, OPHP has held two teleconferences organized by the National Association of City and County Health Officials (NACCHO) and the Association of State and territorial Health Organization.
During the next 4 weeks, we plan to organize weekly teleconferences with state and local health officials, and hospitals, as well as with our agencies that are managing the cooperative agreements. OPHP plans to aggressively work with state and local health officials to ensure that preparedness initiatives are initiated in a timely manner.
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7) What steps has HHS taken to deal systematically with these calls from the private sector? To what degree do HHS agencies coordinate with each other and with other agencies of the Federal Government dealing with the private sector? How does HHS handle calls that should be referred to other agencies?
Secretary Thompson has established the Council on Private Sector Initiatives to Improve the Security, Safety, and Quality of Health Care for the purpose of providing the private sector with a single Department of Health and Human Services point of contact. The Council is triaging requests from individuals and firms seeking review of their ideas or products and forwarding information to the appropriate agencies and offices. This system ensures that DHHS responds systematically and consistently to private sector requests. The acting Chair of the council is Lisa Simpson, from HHS's Agency for Healthcare Research and Quality.
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to be infectious