Department of Defense Briefing by Deputy Secretary Work and Under Secretary of Defense Frank Kendall, Commander Jones, and Dr. Redd on the DOD Lab Review and Anthrax Shipment Investigation in the Pentagon Press Briefing Room

DEPUTY SECRETARY OF DEFENSE BOB WORK: Good afternoon, everybody.

 

Thank you for joining us today. I want to give you an update on our DOD laboratory review and on the inadvertent shipment of very low concentration samples of live anthrax to labs in the United States and three foreign countries. I'll then open it up for a couple of questions and turn it over to the experts who you can dive in and ask any particular follow up questions that you might have.

 

For the past 10 years now, the department has regularly shipped inactivated or killed biological material to other federal and private partner labs for development of biological countermeasures.

 

So for example, if we wanted to have a field detector kit that would tell us that anthrax was in the area, what we do is we work with labs and we work with partners who we then provide these killed spores with so that they would be able to develop a detector that would help our men and women if they encounter such an organism on the battlefield.

 

Now on May 22nd, the Department of Defense was notified by the Center[s] for Disease Control (CDC), and we have a member of CDC here so that you would be able to ask any questions that you might have for them.

 

But CDC told us that a private lab that had been working with the Department of Defense detected the growth of live anthrax from a sample that was supposedly inactivated by the department.

 

We felt that it was an inactivated and safe shipment, a collection of spores. But it turned out not to be the case.

 

Now that immediately started the wheels turning within the department so that we could try to characterize the problem. Now as of right now, this minute, 1409 [2:09 p.m.] this afternoon, there are 51 laboratories in 17 states, one in the District of Columbia, and three foreign countries that we believe have received suspect samples.

 

I would like to tell you that we are going, and we'll say more about this today, we expect this number may rise because the scope of the investigation is going on. And we will update these numbers daily until all the investigation is complete.

 

Now, I'd like to emphasize to everyone here and to everyone watching this that there are no suspected or confirmed cases of anthrax infection among any workers in any of the labs that have received these samples over the last 10 years. And we continue to work with the CDC to ensure that all possible safeguards are taken to prevent exposure at the labs in question, and that any worker that might have had the risk of exposure, even to these low concentrated samples, they are closely monitored.

 

We know of no risk to the general public from these samples. To provide context, the concentration of these samples are too low to infect the average healthy individual. As a precautionary measure however, the department advised any laboratory that may have received any shipment of inactivated anthrax from DOD should stop working on that blot until further instructions are received from the Department of Defense and the Center[s] for Disease Control.

 

The department also directed the four DOD laboratories that maintain the repository for these samples, these anthrax samples, to test every previously inactivated anthrax sample that we have to ensure that it is in fact killed, and that is why the numbers may rise. We have a number -- a number of lots that we need to inspect and verify and it takes some time to grow -- I mean to actually do the test. I think it takes 10 days to actually do the test, and we're in the midst of some of these tests, and that's why the number may grow.

 

Furthermore, after consulting with Secretary Carter, I ordered a review of all DOD laboratory procedures, and that's why the number may grow. Furthermore, after consulting with Secretary Carter, I ordered a review of all DOD laboratory procedures, processes, and protocols associated with irradiating or killing the live anthrax. [It goes] through the same thing as irradiating cancer cells.

 

It's use -- we use radiation to actually kill the live spores.

 

Frank Kendall, our under secretary of defense for acquisition, technology, and logistics, who will have more to share with you in just a moment, is leading the department's review on my behalf and will report the preliminary results to me and the secretary no later than 30 days from now.

 

Now, we're going to look at five things in this review. One, we want to find out what is the root cause for the complete -- incomplete inactivation of the anthrax samples in DOD laboratories? Why didn't we kill the spores when we put them through what we consider to be a protocol that would.

 

Second, after you inactivate the samples, after you kill the live spores, we do sterility testing to verify that we killed all of the spores. Those sterility tests did not detect the presence of live anthrax. We need to know why.

 

We're going to review all existing DOD laboratory biohazard safety protocols and procedures. We're going to ensure and inspect and make sure that every DOD laboratory adheres to the established procedures and protocols, and we're going to identify any systemic problems and take whatever steps necessary to fix them.

 

Now, this review is separate from the ongoing CDC on-site investigation of DOD labs, which we are assisting, and is expected to last several weeks. After the CDC investigation is complete, the department is going to conduct its own investigation with respect to any apparent lapses in performance and to assure appropriate accountability.

 

Secretary Carter, myself, Frank (Under Secretary of Defense for Acquisition, Technology and Logistics), everyone in the Department of Defense takes this issue very seriously because it is a matter of public health and also the health of all of the members of our department.

 

We are acting with urgency, I would say, on this matter. I've directed that all of the testing of the spores are day on stay on. We're going to do it until we get every single one complete, and this is not going to be a nine to five endeavor. We are going after it very, very -- or as fast as we can.

 

And we took the need to identify the initial scope of the issue, to understand what we are dealing with, and to conduct an initial analysis, and as of 1400 [2 p.m.] today, we will have a live website that is activated that will update you on any new information as we go through this investigation. Public safety is paramount. That's the number one thing on our minds.

 

Two, we have to get to the bottom of what caused this issue, and we are doing this. I pledge to you total transparency. This is the first step. We will keep you updated every day, and if necessary, we'll come back and talk with you.

 

And finally, accountability. Those are the four things in my mind that are central to this effort. Public safety, trying to find out what is wrong, transparency, and accountability.

Now with that, I'll take a couple questions. Bob?

Q: Mr. Secretary, you mentioned early on that you know of no risks to the public, health risk. And you mentioned that concentrations of the items were too low to be a health risk. Is that -- could you elaborate on that point? Are there other reasons, or is that it?

And also, is there any evidence thus far of any deliberate human action, any sabotage of any kind of action like that at the lab?

MR. WORK: Let me take the second one first, if I can. There is absolutely no indication that this was -- this happened as a result of somebody deliberately doing this at this point.

Again, we will continue the investigation. But as of this point, there is absolutely nothing to indicate that this would be somebody who is trying to do this deliberately.

This has been going on for 10 years. We have followed these protocols for 10 years. And this is the first time that this has been brought to our attention. So we obviously need to get after it.

First part of the question?

Q: Public health.

MR. WORK: The public health.

As of right now, the only thing we don't like to assign percentages to this. These -- the concentrations of the spores, they're in liquid form,
not in dry form. In liquid form, I mean, the dry form is more you can be infected more easily with the dry form, which -- but these are liquid samples, and I'm going to let the -- I'm going to let the experts talk to you. But normally, all we say is the best as we know is these concentrations are so low as they would be below the level that would normally we would expect to cause any infection in a healthy individual, but we don't like to assign any percentages or anything like that.

Maybe the CDC will want to -- you could follow up with the CDC or Cmdr. Franca Jones when they get to that point.

Barbara?

Q: If the department is so concerned about public health or -- or communicating its concerns about this effort, why did it take the Pentagon more than a week to come out publicly and talk about this matter for the first time, given the level of public concern? Why so many days before you talked about it?

My second question is more than a week later, several days, more than a week later, how concerned are you that you still don't know the full scope of the problem? And is it still correct that you only have one live confirmed sample from the lab in Maryland that reported it to you? Have you come up with any other live? Because the latest CDC count is that there are more than 30 people on protected medical care.

So let's start with why it took so long for you to come out.

MR. WORK: Well, I think it actually happened very quickly as it -- first of all, it was reported from the CDC and the first thing that was happened was an initial investigation.

Okay, what is this, where did this come from, what laboratory did it originate from, where did it go? And as soon as that happened, we came -- it was briefed to me -- well, I knew on the second day, I believe. I was told that we had an investigation ongoing. And then after we met last [week], I ordered the review after talking it over with Secretary Carter.

So --

Q: Why not publicly and talk with the American people about it? It's more than a week. Now this is -- (inaudible) -- the department with respect sir, so long to come out and talk to the American people about this?

MR. WORK: You mean today?

Okay, I ordered the review on Friday and we actually had a debate on whether or not we should go out immediately on Friday. And at that time, the numbers were bouncing a little all over the place. I made the decision to say let me get a little bit more understanding of what the issue is. We had already notified everybody in the labs. We put out a blanket call and said everyone who has these things stopped working on them. Find out where you sent them to.

We believed that we had it very well contained within the DOD laboratory issue, and so I made the decision to take a couple days so that we could -- and the numbers have gone up. Each day until now we have a total of 51 labs.

Q: It has to be a concern to you that the numbers keep going up. How concerned are you that you can't -- you cannot -- nobody can give you a fix on the scope of this problem? Is it still just one live sample?

MR. WORK: Right now, there's two different samples that are involved. Four batches, two different samples. And what we're doing though is I ordered a test on every single spore producing anthrax sample that we have in all of four laboratories. These are possibly hundreds of different lots. So that's why I do believe the numbers may go up. I don't know how many.

But again, they're very, very concentrated in DOD laboratory areas or areas that work in a biohazard facility, so the risk to the public I believe is extremely low. If I had thought that there was a chance that there would have been a broader problem with the public.

I would have immediately come out, but working with CDC, essentially because it was in DOD laboratories or laboratories that work with this on this on a constant basis and because they forward it to laboratories that work in biohazard areas, we were trying -- we thought it was very well contained within there, and we had no reason to believe that there was any health to the broader public.

So when I say public safety, right now I am focused on the public safety of all those people who work with us on these -- on these spores. I have no reason to believe that there's any danger of this causing any type of a[n] outbreak outside the laboratories. And I don't believe that we will have anybody infected that we are waiting to find out.

I'm going to turn it over to the folks who really understand the science of this issue. I'm here to indicate that Secretary Carter and I are being personally informed on the progress in the investigation. We will continue to do so.

Let me just say again Barbara, I want to re-emphasize this, there's -- as far as we are concerned, as of this point, we see absolutely no danger to the broader American public. But for the people who work on these samples, obviously we want to make sure that there's no problem with the people who are working on the samples in the labs and the labs that work with them.

Q: (off-mic) how many people are we talking about (off-mic)

MR. WORK: I would say.

CMDR. FRANCA JONES: We can't answer.

MR. WORK: I can get that answer for you, and I'll have Lieutenant Commander Courtney Hillson get it to you, Bob. I just don't have that number right in front of me.

But we work with a large number of laboratories, and they have subs that they have laboratories, but again, all these laboratories are labs where people really understand how to work with these dangerous subjects.

I mean dangerous substances. And the CDC works with them to establish protocols et cetera.

Q: Did these samples go to all 50 states? Do you know?

UNDER SECRETARY OF DEFENSE FRANK KENDALL: Well, virtually. I'm not sure every single one, but I think they do go to all 50 states.

MR. WORK: Right now, you know, again, I -- we'll verify that for you.

Q: You know we started -- we started with nine states. Now we're up to 17 states, the District of Columbia, and three countries. Why does it take so long to figure out where a supposedly tightly controlled substance like anthrax was actually shipped?

MR. WORK: This is a -- I want Cmdr. Franca Jones to explain you know, the -- once you inactivate them, how they're sent will explain how they are shipped, where they go to, where they can actually send them on. And right now, what's causing the problem is we just -- it takes days in some cases to determine if any of the lots that we are testing have any live anthrax in them.

So that's why I believe that the numbers may go up. But I just don't know at this time how many that might be.

I'd like to thank you all again for being here this afternoon.

Q: There were some conflicting reports yesterday. Was anthrax, potentially live anthrax brought on to the Pentagon reservation or into the Pentagon building? And if so, where exactly was it taken? And if so, why would it be brought anywhere near the Pentagon?

MR. WORK: It was given to the Pentagon Force Protection Agency (PFPA). They obviously do the protection of the Pentagon reservation. They tested - -they would be the ones who would do some testing for it. That testing did not occur inside the Pentagon. And I'll allow Cmdr. Franca Jones to give you any follow up.

Thank you very much this afternoon.

Q: Can you give us a list of states and locations? Can you make that public? And how many people in this population you're concerned about are undergoing protective medical treatment?

We have a real lack of information, as you can tell.

MR. WORK: Right now, my understanding is we can give you all of the states. The individual states, the individual locations, I will defer to our experts here.

Thank you.

[crosstalk]

Yeah, I really have to go. And again, most of these questions are going to be better answered by the people who are dealing with this and understand the mechanisms going on in the investigations.

They've been working this essentially around the clock since last week.

Q: (off-mic) foreign country or South Korea?

MR. WORK: Well, the three countries --

Q: (off-mic) air base?

MR. WORK: Yes, and there are -- there are some of the people who are on the air base are under precautionary measures, but right now we know of three countries.

Thank you very much.

STAFF: So before we get into some more questions, Under Secretary Kendall as well as our subject matter expert here can help frame this for us, and then we can get into some more extensive questions if you have that. So with that, Under Secretary Kendall?

MR. KENDALL: Thanks, Bryan.

As the deputy secretary stated, he has asked me to conduct a comprehensive review of DOD laboratory procedures, processes, and protocols associated with deactivating the anthrax samples used in countermeasure development by the department.

I'm assembling a team of experts from the government and private sector to examine the inactivation processes. They will report preliminary findings and recommendations by the end of June.

The final report depends upon the completion of the CDC's investigation. It will focus on the things that the deputy secretary mentioned: the root cause for the incomplete inactivation of anthrax samples at DOD laboratories, why post-inactivation sterility testing did not detect the presence of live anthrax, existing DOD laboratory biohazard safety protocols and procedures, DOD laboratory adherence to established procedures and protocols, and identification, and what steps should be taken to fix those problems.

I've also been in close consultation with the director of the Center for Disease Control and prevention, Dr. Tom Frieden, regarding their investigation. The CDC is leading the public health response and the investigation of what we believe are the two key technical questions surrounding our review.

Why was there an incomplete inactivation of the spore-forming anthrax samples? And why testing mechanisms to ensure the procedures to inactivate the anthrax failed?

Rear Admiral Steve Redd, director of the Office of Public Health, Preparedness, and Response at the CDC is with us today in case of our questions for the CDC. And we talk a little bit about the context here and amplify on what the deputy secretary said. And when I'm finished with that, I'll ask Commander Jones, who is a PhD in microbiology and is our medical director of chemical and biological defense programs to give you some more background.

First, a little bit of context. Shipments of small anthrax samples are frequent in the government and commercial research space. As part of the process used by the department's chemical and biological defense program to develop capabilities to detect and protect the public and our servicemen and women from chemical and biological threats.

Across the country, there are hundreds of labs that work with anthrax. As part of this mission, DOD ships inactivated or dead anthrax samples to laboratories as well as to industry, academia, and other federal laboratories to help develop countermeasures and for other purposes. The inactivation process requires the samples to be irradiated with gamma rays, then checked to make sure they are dead. The CDC investigation is carefully examining why those two steps failed.

As part of DOD's review of these processes, we are testing over 400 lots or batches to determine how many lots were in fact not completely inactivated.

So far, at least four batches or lots have been found to have live spores present. Because it takes about 10 days, as was said earlier, to be certain that there are no live spores are present, we cannot quite eliminate the other batches yet. We have to wait until the time to be sure that there are not additional live spores.

And the expectation is, given what we've found so far, that there probably will be more live spores. The department has for many years worked with over 100 labs around the country and international. As we identify lots that were not fully inactivated, they are identifying labs that receive samples from those lots. This process takes time.

So the numbers are likely to change and grow as we know more, as was indicated by the deputy.

So again, we are still in the discovery phase of this activity. The numbers of recipients will likely change until we understand the entire scope of the problem. I want to conclude by repeating that our top priority is the safety of all workers and the public. We are committed to total transparency of information as it emerges over the course of our review.

Now, Commander Jones is going to provide some more background and give you a feel for how these are actually shipped. I want to make one more comment before she does that. Basically, we have a very tight number of layered controls on these lab samples, and two of those layers seem to have failed in at least some cases.

There are other layers: the way they are shipped, the way they are in a liquid form instead of an in aerosol form, the low concentrations all mitigate against this being a public health hazard. So there are a number of other layers. And that's the reason that we're not worried about a public health problem at this time.

Commander Jones?

COMMANDER FRANCA JONES: Good afternoon.

I'm Commander Franca Jones, and I'm the director of medical programs for the Department of Defense's chemical and biological defense program. Our program develops medical and physical countermeasures to protect the warfighter and the nation from chemical and biological threats, as part of an integrated, layered defense.

Specifically, we developed vaccines, drugs, diagnostics for medical use and personnel protective equipment such as masks, suits, gloves, and decontamination equipment and detectors. Our office also serves as Mr. Kendall's lead for biosecurity policy for the department.

In order for the DOD and other parts of the federal government to achieve its goals to protect warfighters and civilians from biological threats, it's critical that we work with the commercial and academic sector to get the best technologies for our national security.

The DOD was instrumental in the U.S. government's Ebola response efforts, making diagnostic tests that we developed and made available throughout the nation's hospitals and in West Africa. Many of our vaccines and drugs for Ebola were transitioned into clinical trials in West Africa. Further, the DOD developed the anthrax vaccine, which is currently part of the strategic national stockpile and available to civilians and military in the case of an anthrax bioterrorism attack.

So in order to achieve these goals, the DOD and other government agencies regularly ship both live and dead biological materials for countermeasure development by industry, academia, and other federal laboratories. We have been shipping an activated anthrax as part of our program for at least 10 years.

So what I'd like to do is walk you through the process of an activation of anthrax and the testing that is completed to determine if the agent is killed. I believe we have a slide that's going to be projected.

So first, we start with a bacterial sample that's on a petri dish like you might find in a hospital. And we -- and I want to make the point that as was mentioned earlier, there are over 300 laboratories in the United States that are authorized to use the organism anthrax in research and development processes. The DOD only has nine of those laboratories.

That -- those organisms are irradiated, as you've heard, with a gamma irradiator, and each organism is special. Each organism needs to have a certain dose of irradiation, as well as needs to be irradiated for a certain amount of time depending on its properties.

So after those organisms are irradiated, they are cultured once again to make sure that the process was successful.

Those organisms are grown for at least 10 days in an incubator and are secured just to make sure that nothing grows after that period of time. And if nothing grows, we actually issue a death certificate that says "this organism is now dead." It provides the parameters under which the inactivation was performed, and it's signed to ensure that by multiple individuals, that the process was successful.

Then and only then would a sample be put into a shipping container and sent anywhere to any lab throughout the country. So, now that you've seen the box on the television, what I'd like to do is give you a demonstration of the packaging and shipping process. And the reason why I'd like to do this is I think there's been a lot of confusion in the -- the media and in the public with regards to how we ship inactivated materials throughout the -- the transportation process.

So, let's start with a one milliliter vial. Most of the -- the companies and partners that we worked with received a vial this size with one milliliter of liquid. That's about a fifth of a teaspoon.

I'd like to show you that this -- this vial has a rubber seal on it to ensure that nothing in this vial can leak out. But just to make sure, we put it in a Ziploc bag and close it up as another layer of protection for anything that leaks. As another layer of protection, we provide absorbent material that would be just sufficient to capture the amount of liquid if it were all to leak out of the vial. We wrap it up and we put into another container, again, as you see, another seal to make sure nothing could leak. I'm going to close that up.

And this container is actually a polycarbonate container. It's not going to break.

And then I'll show you, we have our simulant for dry ice. We put it in another box.

So I think you're getting the point that one milliliter of liquid is going to have a hard time getting out of this container. We must ship it on dry ice because the material is frozen, and we want to make sure that it's intact when it gets to its location so our developers of technologies can have intact material. We close it up with the dry ice, then we close it up in the box.

Okay, so that's what we do for live agent and dead agent. There's nothing different there.

The one difference is in the labeling. Whether it's live or dead, we have to label according to the hazardous materials because we have dry ice in this box. If it's inactivated, we will not have the label that says "infectious substance."

So the only difference is in the infectious substance label.

So when we talk about risk to the public and what's happening with this box and workers who might have handled this box in the transportation chain, we believe that the risk is zero for the general public as well as for the people who have handled this box. One
milliliter of liquid is not going to come out of this box.

Where we believe the risk to -- to be potential but extremely low is at the initiation of the packaging or at the individual who has received it. And I know your concerns are most focused on the laboratory workers who may have handled this material. And we can talk about that in a little bit.

So finally, we understand that there's public concern around the incident. I want to assure you that samples in question were tested using an approved protocol and shipped by the method that I had just described.

No live anthrax should have been in those boxes at all, but as the -- as Mr. Work and Mr. Kendall have already described, we are investigating with the CDC's help to understand how that could've happened. So, I look forward to answering your questions.

MR. KENDALL: Okay, start right here.

Q: Yes, were all of the samples that have been -- live samples sent from Dugway? Also, is there a two-person rule as far as working in labs at Dugway and is there video monitoring inside of the labs?

MR. KENDALL: I'll answer part of that, and I'll turn it over to Commander Jones for part of it. There are four labs involved here. The only one that we have identified -- four DOD labs. The only one we've identified any samples that still contain live or active spores was from Dugway. The other labs are Fort Detrick, Edgewood, and the Navy's medical center.

So, we're checking everything. We're checking all of our labs and all of the batches we've made to make sure we don't have a problem anywhere. But so far, the only confirmed live cases are from Dugway.

Do you want to take the other part of that?

CDR. JONES: Sure thing. All of the labs in the United States have to adhere to the select agent regulations for handling of this kind of material. All of the labs that are part of that program must have a personnel and a physical security plan that's based on a site-specific risk assessment.

So each and every site must develop those protocols. Some of those protocols may include video monitoring. Some of those protocols may include a two person rule.

Q: Do they at Dugway?

CDR. JONES: I cannot comment on the specific protocol at Dugway.

MR. KENDALL: One of the things we're going to be looking at through my review is the protocols are in place at various places and why they're different and whether they're adequate or not.

So that's definitely going to be subject of my review.

Q: We've been told, so as you've described this, the first alarm bell on this came when the laboratory in Maryland produced live spores from the sample that they had received. And you've described how the -- these samples are used in you know, developing biodetection. What was the lab doing in Maryland that prompted it to culture the sample to produce the live spores when --

MR. KENDALL: What happened in that case was these are supposed to be dead spores. So they're used for the purposes for which one uses dead spores, which is often to verify detection capability and so on.

For some reason, a subcontractor of one of the labs we shipped to in that case cultured some of the supposedly dead spores and found out they're not.

Normally there'd be no reason to culture, because the expectation is for there to be no result. Why they did that at this point I don't know.

Franca, do you have any more information on that?

CDR. JONES: No sir, that -- that's exactly --

Q: So one of the things I'm just trying to understand is, when we're talking about -- you talked about the reasons that this poses the very small risk because of the -- the liquid form and the low concentration. But is it also -- help me understand that -- if you haven't taken this process in the laboratory where you actually culture and produce a live spore -- is it -- is there also a minimum risk in this form where it's supposedly dead but apparently not totally dead?

Is there a risk to -- I guess what I'm saying is, unless you culture it, is there really a risk to this material that's not fully inactive?

MR. KENDALL: Because of the low concentration, it's generally not a sample that's large enough to place an individual at risk. And Commander Jones can amplify on this, too, and Admiral Redd may as well.

But for a person who has a healthy immune system, it takes a certain level or number of spores, basically, for them to contract anthrax, and this sample's well below that level. That's one of the things that mitigates against it.

We -- one of the things we're trying to find out is how -- what the history of this, in terms of whether we have an isolated incidence here -- we've now found out numerous batches, so we know it's not just one batch -- whether it's other places than Dugway, how long this has been going on, to a number of things, and that's really at the heart of what CDC is investigating as well.

So we still have a lot to learn about the root causes of this particular incident.

Q: (off-mic) if the danger comes after it's been cultured -- so for instance, the Pentagon Force Protection Service, who received a sample, presumably used it to calibrate equipment or whatever they would've it for, they wouldn't have put it in a petri dish and grown it for 10 days.

I'm just trying to understand if that's where the danger part comes.

CDR. JONES: I understand your question, but the material inside the vial is -- is still alive, and so whether you're culturing it or not, it's still alive.

Culturing, however, gives you the ability to grow more, so certainly, your risk increases if you grow more of the material than is just in the vial.

I think importantly, to get at your question, is that we've already reported here today that we have found batches of material dating 10 years back. People have been working with this material for 10 years, and nobody has contracted anthrax from the material, which gives us more confidence that -- that the risk is really low, as we are stating.

MR. KENDALL: If I could just add to that, we ought to be careful as we speak about this. We're trying to do that, to not maximize or minimize the degree of concern here, okay.

We think there is a minimal degree of concern, virtually none, for public health. There is some degree of concern for our lab workers, and that's why we have -- I think it's 31 people now that are in a prophylaxic program, because of possible exposure.

So we're going to work through this very carefully. It's a serious matter, but it's not a matter for widespread alarm.

Q: But you say going back to 2005, at least, that -- that these live samples were -- were --

CDR. JONES: We have -- we have lots back to 2005, and I will have to get the actual number, but I believe the first shipment may have been done in 2006.

Q: How many -- how many overseas military bases and U.S. defense facilities receive anthrax as part of these bio-protection programs?

MR. KENDALL: We'd have to get that information for you. I don't think we have that right now.

Q: Don't even have a ballpark estimate? More than one?

MR. KENDALL: No, I'd rather give you accurate data. I believe it is more than one. I know of one for sure. It's one of the ones we've found some material at.

Right here in the front?

Q: The four batches that have tested positive, can you give us -- (inaudible) -- that's over 10 years. How many total batches did Dugway produce during that time? Like, what's the percentage that ended up being positive here?

MR. KENDALL: The total number we're testing, I think is 400, isn't it?

CDR. JONES: At -- at all four laboratories, we're testing at least 400, probably over 400. Dugway has some portion of that 400.

Q: But -- so -- so -- but what I'm trying to figure out is how many of the four batches that you know so far are positive, how many total batches there were that were produced during that same period of time at Dugway. Do we know that? Is it one percent?

(CROSSTALK)

CDR. JONES: Right. So as was stated earlier, it takes at least 10 days to determine that something is negative. So we can only tell you what so far has grown positive, but we can't tell you the percentage of all of them, because until we can determine how many are negative, we cannot give you the denominator.

MR. KENDALL: Of the 400, only a few have been through the full protocol testing, so it's very early to talk about numbers that are -- that have active spores at this point.

And we -- we can probably get you the number for how many of those -- those batches came from Dugway, but I don't have that right now.

Q: And then also --

MR. KENDALL: I'm going to give somebody else a chance. Sorry.

Q: Can I just get one clarification, because Secretary Work brought it up?

The -- the -- the -- he said the 51 labs, 17 states -- (inaudible) -- those -- those are all ones that are from those four batches, correct? That's -- that's not some other batch? Because he -- he used the word "suspect" samples. There's not --

CDR. JONES: Those are the numbers from -- from those four batches.

MR. KENDALL: Right there.

Q: Yes. I was looking for some additional explanation on the international side of this. It's Australia, Canada and South Korea, correct?

MR. KENDALL: Yes --

Q: Is there any indication or belief that those -- that suspected samples may be in other countries or has been sent to other countries, military bases or otherwise?

CDR. JONES: We do not have answers on that now. Over the weekend, our individuals at the labs were doing inventories to track down where all of those were sent. But we do not have information on that now.

Q: Are you testing batches that were sent up -- sent outside the --

CDR. JONES: We don't have information on where things were shipped yet, because we're still trying to identify all of the samples that exist.

MR. KENDALL: We are testing all the batches.

CDR. JONES: We are testing all the batches regardless of where they went.

MR. KENDALL: Way in the back?

Q: I was wondering if you could give me more specifics on the -- the eradication process.

The aliquot that you -- that you take, what percentage are you taking?

CDR. JONES: In which --

Q: You -- you use an aliquot of a sample to determine whether it's been eradicated or not, and if so, what percentage are you using?

CDR. JONES: Yeah, so we have protocols that we're reviewing as part of the undersecretary's review now. My understanding is that we take five percent of the solution, and that's based on scientific literature.

What I can't answer for you right now is what the total solution is.

Q: You mentioned that it's based on scientific literature, but most usually put it somewhere between 10 and 20 percent.

Do you know who made the determination that five percent was an adequate number, and could that be a factor in why some of them came out not being eradicated?

CDR. JONES: I can't answer specifically your question, but that is an area that's being looked at.

MR. KENDALL: That's an area that I know the CDC's looking at, too. And it's kind of early, I think.

Admiral, do you have any comments on that, or --

REAR ADMIRAL STEPHEN REDD: Really, I think -- I think that the information that you're reporting is what I have as well.

Q: And Mr. Secretary, can you clarify something?

One of the things that Secretary Work talked about was the need for transparency, and yet you're not saying where these labs are that were affected. And I've talked to people in a number of areas who are hearing their states listed and don't know if it's their labs who are affected.

So can you help me understand why the labs themselves cannot be publicized, given that it's cause for concern for people in some of these labs who don't know if they're affected or not?

MR. KENDALL: I -- I don't have a good answer to your question. I don't know why we couldn't publicize that. We don't want to spread alarm about this, because we don't think there's a general cause for concern.

We'll take -- we'll take that one to look into and see if we can publish the labs.

CDR. JONES: We -- we can -- we can tell you that all of the labs that we know to have received these samples have been notified directly by the CDC and by the Department of Defense. So the lab leadership should be sharing that information within -- within the lab.

MR. KENDALL: If we thought there was a public-health risk, we would certainly be sharing that information.

Q: Have those countries been notified, host countries, if it's in a military lab or in a military base? Has the host country been notified?

CDR. JONES: Yes.

MR. KENDALL: Right here in the front? You had one?

Q: Yes. You had mentioned that were 400 batches, the four that have tested with live samples. Out of how many have gone through -- as of now, how many have gone through the testing?

CDR. JONES: Those four had gone through the full 10 days of testing. We do not have any --

Q: (off-mic).

CDR. JONES: Right. We have not done any others at this time.

(CROSSTALK)

CDR. JONES: Four have gone through the testing. There are others that have not completed the full testing, so I don't have the number for you today.

(CROSSTALK)

CDR. JONES: There have been negatives, but they are maybe at day four or day six or day eight.

So the way that this works, and just for clarity, if you have a positive sample, you will know in 24 to 48 hours if it's positive.

In order to really say that it's negative, we want to wait for 10 days to make sure that anything that was irradiated isn't able to somehow regenerate itself and ultimately result in growth at a 10-day mark.

Q: So just to clarify, 400 are currently being tested at this time?

MR. KENDALL: 400 batches.

Q: 400 are being tested. Four have come back positive. The others have not given a positive yet, but you have to complete the full 10 days to know for sure.

Also, a follow-up, there was mention that two samples. We know of the one in Maryland. What's the other live sample that's -- that's come back?

CDR. JONES: So let me clarify that. The one sample from Maryland was the initiating sample. The CDC requested that all of the labs that had received the sample send it to the CDC.

So each one who received an aliquot sent it back to the CDC, and the CDC did testing, and what we know is that nine of the nine that they received back from that original sample have tested positive.

So from nine of the labs in that initial -- from the initial investigation have come back from the source material at Dugway, the laboratory that reported the positive on May 22nd, and nine additional laboratories had all received the same sample, have sent those to the CDC and those have tested positive.

Q: So what did Secretary -- Undersecretary Work mean when he said four batches, two samples, possibly hundreds of different lots? What was he referring to when he said two samples?

CDR. JONES: I'm not sure what the two samples were. There are four lots that tested positive. There was one sample that tested -- was the initiating sample on May 22nd, and the CDC is collecting -- I believe that's altogether 19 samples from the labs that received that initial material. Nine thus far of those have tested positive. The other 10 will be tested here in the next couple of weeks.

Q: (off-mic).

CDR. JONES: So remember, there were -- in the initial reporting, we reported 19 -- 19 -- I don't remember, excuse me, if -- (inaudible) -- 19 or 24, but we reported an initial tranche of -- of laboratories.

So there are 19 that are sending samples to the CDC. Nine have been received by the CDC. Nine have been tested and are positive.

The other 10 from that initial 19 are going to be received. They have not yet been received at the CDC. They will be received at the CDC. They will do the testing, and they will determine whether those 10 are positive.

Altogether, 19.

(CROSSTALK)

MR. KENDALL: Let me give somebody else a chance. I'm sorry. Let me get somebody else here.

(inaudible )?

Q: Just to get the number right, does that nine include Maryland, or not? Is that nine plus Maryland --

 

Q: Was it 10 or nine?.

MR. KENDALL: Let us check that for you.

CDR. JONES: I'll have to check. It's -- because there are several -- there are several samples coming from different places. Let me -- let us check.

MR. KENDALL: Okay.

Q: Then more labs, with revelations yesterday, but now I'm confused. Are you saying 19 labs?

MR. KENDALL: You have to accept that these numbers are in flux and they are changing constantly as we get more results. I wouldn't obsess about the numbers at this point. Okay, they're going to change.

One of the reasons we put up the website, we're going to be posting daily updates is because of that fact. So we'll have accurate numbers as they come in on that website, but they're going to change every day as we go through more testimony.

Q: Nine labs from different states? Are we talking additional states beyond Maryland that tested positive?

CDR. JONES: So, remember we had the May 22nd event, and that caused us to look to see what additional labs may have received the sample, so the original sample and information came out of Maryland, and then there were additional states that were identified that have received that material from Dugway, and we went and found those, and then we found more. So we did a complete trace forward of the labs that received that original sample, and I believe when we came out with our initial reports, that was the first, and as I'm calling them, tranche of samples to include the number of labs, number of states.

We then initiated culturing of other lots, and so you also have to understand that this 'has happened in waves. So we also then started culturing other lots from Dugway, and that's how the numbers have continued to change over time.

Now that we're going to be culturing lots, more lots from Dugway and more lots from our other laboratories, then these numbers will continue to change. Again, why -- why Mr. Kendall said what we reported today with the number of labs, the number of states, the number of personnel on prophylaxis, is the accurate number for today and we can move forward daily with updates to you.

MR. KENDALL: At (inaudible).

Q: (off-mic) for the last 10 years, there have been samples that have sent out. Are we talking thousands of samples at labs across the U.S.? Are we talking hundreds? Just to give us a better understanding of what is the scope size we're looking at.

CDR. JONES: We reported today that we're culturing at least 400 and that is the bottom --

MR. KENDALL: 400 lots.

CDR. JONES: Lots.

MR. KENDALL: And each lot is many samples, I believe, right?

CDR. JONES: That's correct.

Q: Each lot, you're sending samples out to labs in those vials. So how many boxes of vials are we talking over 10 years?

CDR. JONES: Right, so I can't give you the number today. That is part of the investigation looking into how many lots there are, how many samples were shipped, and to who.

Let me make one more point if I can, sir. There are a limited number of laboratories in the world that do this kind of work, and some of what we're finding is that while we may have made multiple shipments of different strains, we're finding that many times, these are going to the same labs because they are the ones developing these kinds of technologies.

So, I don't believe that we'll find that there will be 1,000 labs out there that will have received this material. We will -- we will -- we have found we went from 24 to 51 because we found one lot but many of those were -- were a repeat.

So I think we just want to make the point that we will find more labs, we will find more lots, but we will -- we have an understanding of the community of interest here, and I think we will have a boundary on that.

STAFF: Okay, now let's go ahead right here.

Q: Two quick questions. These batches that tested positive, are they all from the AG-1 batch? That's what we were told initially.

CDR. JONES: No, they are not. So the original, again, when we talk about tranches, the original tranche was all from AG-1. And when we worked on culturing more material, we found new batches of new strains, so we have, you know, we have different -- we have a Canadian strain in our repository. We have a Jamaican strain in our repository. We have what's termed the Ames strain in the repository.

So, AG-1 was the Bacillus anthracis Ames strain. So as we culture these other lots of Bacillus anthracis, we will have multiple different strains in the repository and we will know who that strain was sent to as part of our trace forward protocol.

Q: And one more thing. What's the difference between the test off to the -- the irradiation before the death certificate and the tests that you're doing now to determine that they are in fact active or not?

CDR. JONES: Yeah, that's a -- that's a very good question. There is no difference in the test.

MR. KENDALL: That's one of the questions we have is why didn't that test work properly the first time?

Q: (off-mic)

Q: Mr. Kendall, the question number one is you said the protocol changed about 10 years ago, but you don't know -- do you know any details about how the protocol to irradiate these changed at all in terms of what might have worked in the past and doesn't work now?

MR. KENDALL: One of the questions, and CDC may want to comment on this, is that the protocols are not always the same in every lab. There is no one defined, say national protocol that everybody follows. There's general guidance from the CDC about how to do this. To answer the question that you asked earlier, in fact.

So one of the things we've got to look into is exactly what protocol was followed in this case, and how might that differ from what it's done in other cases.

Do you want to amplify that, or --

Q: Military to military?

REAR ADM. REDD: I would just agree with what you're saying, that the tests that are -- the methods that are used to inactivate these specimens in general, there are several different methods. The laboratories can pick the method that they wish to use. They developed the method based on the scientific literature, and then there was a check to make sure that the method was effective. And what we know now is that both the irradiation method and the method to check that the irradiation had been effective failed.

And that's really, in terms of the long-term questions, those are the things that are being investigated.

Q: Admiral, one while you're up here, are civilian labs able to further distribute these samples? Mr. Kendall mentioned the subcontractor that worked with it within one of these labs. And two, is the CDC closer to release -- making a decision for that agency to release the list of labs?

REAR ADM. REDD: Well, the -- we -- the information that we have is from DOD, so it's -- the -- in other words, the question is these laboratories that received the specimens received them from DOD. Because they are presumed to be dead, inactivated, they're not regulated, and so they are able to be sent further down. And that -- that's part of the trace forward that Commander Jones described.

Q: So, do you have any idea what the failure rate we're dealing with here? Because, you can see what we're grappling with here. On the one hand, you had four positive out of 400. That's just one percent. But on the other hand, you also had, from this one batch, -- essentially -- 100 percent so far have come back testing positive.

We know the failure rate's not 100 percent. It's probably not one percent either. Do you have any idea where we are on that scale?

MR. KENDALL: Well, I'll let you answer that, but that's one of the things we're trying to determine: how widespread this is and what the root causes are. Is it isolated to Dugway and their radiation and maybe their quality control over things that were going out, or is it wider spread than that?

That's one of the things we're trying to (off-mic).

Q: You don't have a sense of it, even at this point?

MR. KENDALL: I don't think we do at this point. Do you want to?

REAR ADM. REDD: I think that's -- that is really the work that Commander Jones described to do cultures of all these lots to be able to answer that question.

MR. KENDALL: We're waiting for those cultures to go through the full protocol period that the commander described.

I know it's hard for you to be patient about this, but I don't think the time frame to have much better data is what, days to a week perhaps?

REAR ADM. REDD: I think it's going to depend on the number of lots that -- you know, how long it basically takes to culture those 400 lots.

MR. KENDALL: All right.

Q: (off-mic) labs are that can ship inactive samples around and what the rate is, like an average rate for them to actually be sending live samples?

REAR ADM. REDD: I don't have that information. We can -- we can try to follow up with you on that.

Q: Can you help me understand what percent are you using now in the testing now? Are you still using five percent, or are you using more?

MR. KENDALL: No, we're not doing anything --

CDR. JONES: I really -- right. So, so I can't comment, but I'll have to get back to you on that.

MR. KENDALL: We have basically stopped this work while the investigation is up.

Q: But you're testing the samples now, the lots, to determine if they're positive or not. What percentage are you using?

REAR ADM. REDD: I don't know the answer to that question yet.

Q: Can I ask about -- a question about the people who are taking the prophylaxis? Are they -- are we talking civilian lab workers? Are they active duty lab workers in the United States? Are they at Osan Air Force Base? What -- what's going on with those folks? And if it's such a small risk, why are they on prophylaxis?

MR. KENDALL: It's a mix of DOD employees and civilians. I think there are a few that are -- I don't know if they're active duty. I know there are DOD employees. Do you want to say more about that?

CDR. JONES: Yeah, so --

Q: How many labs you work with in Canada?

Q: Can I get my answer to my question answered first?

CDR. JONES: Yes. So there are 22 people at Osan Air Base that are on post-exposure prophylaxis. There are some active duty. I don't have the exact number in front of me right now, but some of them are DOD civilians and some are DOD contractors.

There -- were -- were -- what was one individual in Maryland at a DOD lab who requested post-exposure prophylaxis, and we have provided that as per their request. And then there are seven others in the United States on the civilian -- in the civilian labs that four of -- excuse me, four of those were recommended by the CDC and their state public health officers to be on post-exposure prophylaxis, and one of the states determined that some others within their state and their laboratory should go on post-exposure prophylaxis.

So it's 31.

MR. KENDALL: We'll take one more question.

Q: (off mic) Contain the four positive samples?

The four positive batches.

CDR. JONES: So, the four positive batches originate at Dugway and are at the 51 laboratories that we have briefed earlier.

(CROSSTALK)

MR. KENDALL: Okay, that's going to be it. Thank you. Thank you very much, everybody.

COL. WARREN: I appreciate it. Thank you guys. I know there's a lot of questions. We'll try to do better, but we've already been here an
hour. You all are stepping on each other.