Department of Defense Press Briefing by Deputy Secretary Work, Under Secretary Kendall, Dr. Jones, and Dr. Majidi on the DOD Comprehensive Anthrax Lab Review findings in the Pentagon Briefing Room

Presenters: Deputy Secretary of Defense Bob Work, Under Secretary of Defense for Acquisition, Technology and Logistics Frank Kendall, Biological Defense Program's Chief Medical Officer, Dr. Franca Jones, and Chairman of the Comprehensive Review Com


            STAFF:  We're going to be hearing first from Deputy Secretary Work.  He has some opening comments, and will then take some questions.  He's then going to -- he has to leave us, and then we'll be turning it over to Under Secretary Kendall and his team for follow-ons after that.

 

            DEPUTY SECRETARY OF DEFENSE BOB WORK:  Well, good afternoon, everybody.

 

            Today, I want to give you an update on the Department of Defense's investigation into the shipment of live anthrax spores to both DOD and commercial laboratories inside the continental United States, as well as overseas.  And after that, as was just said, I'll take a couple question and then turn it over to the experts.

 

            Since 2003, the Department has periodically shipped what it thought was inactivated or killed samples of Bacillus Anthracis, or anthrax, spores to selected laboratories. 

 

            Now, we do this to create medical and physical countermeasures to protect our troops, our allies and partners, and the American public from the threat of biological attack.  We do this because we know that in the past some nations have pursued biological weapons, and we can't be certain that they will not be used in the future.

 

            On May 22nd of this year, the Center[s] for Disease Control and Prevention, CDC, notified DOD that a commercial research facilities had received supposedly inactivated samples that contained live anthrax spores.  We quickly determined that the sample originated from Dugway Proving Ground in Utah, and it was shipped through the Army's Edgewood Chemical Biological Center in Maryland.

 

            Two days later, after consultation with the CDC, all shipments of inactivated biological agents or what we thought were inactivated, from Dugway [Proving Ground] and the Edgewood facility, were halted.  And the very next day, we expanded that to include a moratorium on all shipments of inactivated anthrax material to and from all DOD laboratories. 

 

            On 26 May, CDC began an investigation into what happened at Dugway [Proving Ground] and Edgewood, and three days later, I initiated a broader review of DOD laboratory procedures, processes, and protocols associated with inactivated anthrax spores to determine if this was a one time procedural failure at Dugway Proving Ground, or if it was a more systematic problem in the department's biohazard safety procedures.

 

            I direct[ed] to Frank Kendall, our under secretary of defense for acquisition, technology, and logistics to oversee this procedural review.

 

            Frank assembled a team.  The bios are actually are in the report.  This was an expert team that included representatives from the Department of Agriculture, Energy, Defense, Homeland Security, the Federal Bureau of Investigation, academia, and industry.

 

            They conducted a comprehensive review of all procedures, processes, and protocols on the four laboratories, at the four laboratories that work with inactivated anthrax spores.  And particularly, those procedures that were associated with the inactivation of what -- of live spores, and then the viability testing to determine if they were indeed killed.

 

            While this review [was] underway, the department and CDC worked together to test and then retest every single inactivated anthrax batch that we retained in our inventory.

 

            Now, the review team reported their findings and recommendations to Frank on the 13th of July, 10 days ago.  And after his thorough review, and I have to say thorough review, I received his forward endorsement yesterday.

 

            In the meantime, Secretary Carter and I discussed the findings of the report, its implications, and what we might be doing, and I'd like to share with you some of the findings and recommendations of the review.

 

            The review showed that since 2003, our four DOD laboratories irradiated a total of 149 batches of live anthrax spores and reported them as inactivated and safe for subsequent testing.

 

            Every one of those batches have been accounted for and either tested or destroyed.

 

            Fifty three of the 149 batches are no longer in DOD inventory.  Again, we've been doing this since 2003.  And they were [sic] not available for testing.

 

            Any recipients of those batches who still have any samples on hand were told to destroy them.  Now, that left us with 96 samples or batches to test.  Seventeen of those 96 tested positive for the regrowth or presence of live anthrax, and every one originated from Dugway Proving Ground.

 

            Of the total batches in Dugway's inventory, more than half tested positive.  Seventeen of 33 batches at Dugway [Proving Ground] were tested positive.  Now obviously, when over half of those anthrax batches that were presumed to be inactivated instead proved to contain live spores.  We have a major problem.  And the numbers confirm this judgment.  At this point, we know that over the last 12 years, 86 laboratories in 20 states, the District of Columbia, and seven foreign countries ultimately received what was supposedly inactivated spores that were live.

 

            And all originated, as I said, from Dugway Proving Ground.

 

            I expect those numbers to increase.  The 86 labs that we are reporting today include all inactivated anthrax samples that were received directly from Dugway Proving Ground laboratory.

 

            However, these receiving labs could in turn send samples to other laboratories to help them in their procedures or testing.  And CDC is responsible for tracking those secondary and tertiary shipments.  And we expect to hear the results of their work very, very soon.  Those will increase our numbers.

 

            We will continue to work with CDC and update our website to reflect CDC's findings as soon as they become available. 

 

            Now, we are extremely fortunate that the live anthrax samples came in liquid form.  Anthrax has spores, and is therefore generally transmitted through spores in the air and that you breathe, come in liquid form in extremely small amounts, vials maybe about this size.  They were handled in laboratory environments by technicians and workers that were used to handling hazardous material, and there was extremely low concentrations of spores in these samples.

 

            This helps explain to us why over a 12 year period, there has never been a single incident of infection.  And we are very, very confident that because of these unique circumstances, there were no known risks to the broader public.  A healthy person would have to purposely ingest, drink the sample, or inject it, and would have to do it several times for them to become infected.

 

            Now Secretary Carter, myself and the senior leadership of the department, take absolutely no comfort in this fact.  By any measure, by any measure, this was a massive institutional failure with a potentially dangerous biotoxin.  So the first thing we had to know was why did it happen?

 

            The review concluded that there were three main causes to this failure.  The first and the most broadest one, and the one that surprised me perhaps the most is there is no national standard at all for -- or any standard to guide us for the development of protocols, processes, and quality assurance measures in the preparation of inactivated anthrax spores.  They just do not exist, even though laboratories across the country do this routinely.

 

            Said another way, as I said, there's no national standard.  So each of the labs had to make their own protocols and test them for their viability.  Now obviously, in the other labs, it seemed to work.  Dugway [Proving Ground] it did not.  We believe we know why.

 

            There's a combination of large production volume, low sampling volume on the testing for inactivation material for viability testing, and there was a very short period of time between the time Dugway [Proving Ground] irradiated the sample and declared it dead, and then the viability test to conclude that it was.

 

            So we think that is why there was a very high -- higher likelihood at Dugway [Proving Ground]for a problem to occur and the numbers seem to bear this out.

 

            Third, there are no biosafety protocols and procedures that are standardized across DOD.  That's another thing that surprised me a lot.  And this is partly due to the fact that the laboratories are under different chains of command.  So this is something that we have to take care of.

 

            So given these findings, we obviously as a department have a lot of work to do.  A lot of work is cut out.  I mean, we have a lot of work cut out for us.  The American public expects more from the Department of Defense, and we expect much more of ourselves also.

 

            Secretary Carter has made plain to me and all the senior leadership of the department that he expects these issues to be dealt with swiftly and comprehensively to ensure that a failure of this sort never happens again.

 

            Accordingly, I am taking the following actions.  I have directed Under Secretary Kendall to first work with DOD stakeholders and the CDC and all other relevant departments and agencies in the U.S. government to develop standardized irradiation and viability testing protocols for all Department of Defense labs that work with spore producing organisms like anthrax.

 

            I told him to ensure that there is efficient funding available through the chemical and biological defense program to support the research and development of these standardized irradiation and viability testing protocols.  If he feels there is not enough money, he can bring it to me and the vice chairman of the joint chiefs of staff through the deputy's management action group, and we will take action to make sure that those funds are made available.

 

            I've also asked him to review and revise as necessary all DOD biosafety and biosecurity policies to ensure consistent application across our four laboratories, and to oversee the military department of service implementation of the review of committee's recommendations.

 

            In addition, I've directed the secretary of the Army to conduct a full accountability assessment of those responsible at Dugway Proving Ground, to include initiating a formal investigation of the specific actions that contributed to the unintended shipment of live anthrax spores. 

 

            Within 30 days, the secretary of the Army in coordination with the secretary of the Navy, three of the labs report under the Army and one of the labs report under the Navy, developed an implementation plan for addressing the specific recommendations of this report, particularly on quality assurance, pier review, and program management and to provide quarterly updates on the progress to me.

 

            Review laboratory missions and chains of command and provide policy and organizational recommendations to ensure that there is a consistent application.  As I said, one of the things is that they're across two different military departments and across four different chains of command.  So we need to address that so that we have standardization across all four. 

 

            I've also asked the secretary of the Army to assess the optimal distribution of research, development, and production activities in DOD laboratories that support the chemical and biological defense program mission.

 

            Finally, I designated the secretary of the Army as the DOD executive agent for the biological select agent and toxin, or what we call BSAT, biosafety program.  As the DOD's executive agent, the secretary of the Army will be responsible for the technical review inspection and establishment of these common biosafety protocols and procedures and he will have the authority to ensure their strict implementation.

 

            I've asked the Army to designate a certified biological safety officer to execute this responsibility for him.

 

            Now, until all of these recommendations are addressed, in place, and Under Secretary Kendall has told me that they have been addressed, I've directed a moratorium on -- a continued moratorium on the production handling, testing, and shipment of inactivated anthrax.  That will continue except as required for development of these standardized, peer reviewed, validated protocols for the inactivation and viability testing of the spores.

 

            Now this review taught us lessons we needed to learn.  We were quite frankly surprised by them.  They identified institutional and procedural failures we urgently need to address.  We are shocked by these failures.

 

            I want to stress to you that DOD takes full responsibility for these failures.  We are implementing changes and recommending the establishment of procedures, processes, and protocols that will prevent such a biohazard safety failure from ever happening again.

 

            In fact, we hope that the lessons learned that we are learning will encourage the development and establishment of a national inactivation viability testing standard for every lab in the United States to follow.

 

            Before closing, I just want to reiterate that there is no known risk to the general public or to our allies and partners or to our servicemen and women.  There have been zero cases of anthrax infection over the last 12 years.  And we continue to partner with CDC to ensure safeguards are instituted.  Once again, however, this statement in no way is meant to minimize the severity of this failure.  It was absolutely inexcusable.

 

            In closing, let me say that Secretary Carter, myself, and the senior leadership of the department want to commend the laboratory that first notified CDC of this problem and set this review in motion.  It was because of their notification that the department was able to take immediate action and to stop all shipping of inactivated anthrax to assess our procedures, processes, and protocols, and to begin to institute the needed changes that were so obviously needed.

 

            In doing so, they helped to ensure no one was affected by anthrax. 

 

            With that, I'd like to open it up for a few questions.  Barbara?

 

            Q:  A couple of things.

 

            I think I heard you mention the FBI.  And I have not heard that the FBI was involved in this until today.  Can you tell us number one, why did you bring the FBI into it? 

 

            Number two, although you have this accountability review, it is an Army review if I understood you correctly -- if this has gone on for years with no one noticing, what makes you believe the Army can adequately investigate itself?  Why are you not doing an independent review?

 

            Who do you think is responsible?  You must have some idea.  It can't be just the bureaucracy.

 

            And my third question is, how can you be certain standing here today, that there are no other germ biological chemical hazardous agents that the Defense Department deals with in ships, that aren't facing the same problem?

 

            How do you know it's just anthrax?

 

            MR. WORK:  Those were -- there were a lot of questions in that one, Barbara. 

 

            Let me -- Okay.  Let me start.

 

            The FBI, obviously we wanted to make sure that this wasn't the result of a bad actor who was doing this on purpose and we were able to determine that that was not the case.

 

            Second thing, responsibility.  This first review was designed primarily -- when I asked the question on the 29th, I said how in the world could this happen?

 

            I was more interested in finding out what was the cause of the problem. And that was the focus of the review.  After doing the review, Frank made the recommendation that said "look, although we didn't have the under -- although we didn't know the viability standards were false, we need to get to this, but still, there were things that were happening in Dugway [Proving Ground] that obviously we should review more closely.

 

            That's why we then ask the secretary of the Army, who was responsible for the Dugway  [Proving Ground] chain of command, to execute the accountability and the investigation into exactly what happened.

 

            Q:  Why do you think there doesn't need to be an independent review since Dugway[Proving Ground] has had known problems in the past, that for some reason the Army hasn't noticed in years.

 

            Why not an independent review to reassure yourself of full independent investigation?

 

            MR. WORK:  I have full confidence in Secretary McHugh and I expect him to be able to review this in very great detail and provide recommendations to us on exactly if there is and who is responsible for these lapses at Dugway [Proving Ground].

 

            Q:  And how are you sure there weren't other agents out there with the same -- facing the same problem.  How do you know it's just anthrax?

 

            MR. WORK:  Well, I might ask Frank to do this.  We were looking at all spore-producing  -- all spore-producing organisms, but we were focused obviously on anthrax.  We have very high confidence in the shipment of these materials.  We have very confidence it's being  handled within laboratories by trained people.  We feel that our protocols that are established are being followed.

 

            The problem that was showing up in this review is we have to look at the protocols themselves and make better standards.  So I have a very, very high confidence at least at this point that there are no other issues that we are unaware of.

 

            Jim.

 

            Q:  Mr. Secretary, what was so different about the protocols and procedures at Dugway  [Proving Ground], than the other four installations that could have caused this problem and -- and in this investigation, did you find any evidence of malfeasance, negligence, among those who are responsible for that testing. 

 

            MR. WORK:  Let me take the second one first, Jim.  There was no findings of malfeasance or wanton you know, misuse of protocols.  That was the protocols themselves that were at fault.  Now the protocols at Dugway [Proving Ground] were particularly problematic.  It is a production facility, so 86 of the 149 batches were created in Dugway[Proving Ground]. It is our primary production facility.

 

            They would make large concentrations.  I mean, large batch sizes.  So the sizes of the batches were larger than the other three laboratories that generally worked with smaller samples.  Then their irradiation procedures obviously didn't work.  And the time between the time they irradiated the samples and then they tested it for viability was too short.

 

            So as a combination of these factors, we believe where this is the reason why as high as 50 percent of their batches ultimately proved to be live.

 

            Q:  But who was ultimately responsible for that?

 

            MR. WORK:  The technical director.

 

            UNDER SECRETARY OF DEFENSE FRANK KENDALL:  This is unfortunately a very complicated situation.  Anthrax is a very unique organism,  It is the only organism like it that is considered a biological agent.

 

            Because it exists in this spore situation, a spore form, it is harder than a bacteria of ours, for example, to kill and know exactly where you are in that process.

 

            The processes at -- at Dugway were not as rigorous as processes at some other places, but not by an enormous margin.  The team that Vahid led that looked at this found differences there that were indicators of factors that either individually or in combination could've contributed to the fact that they weren't as successful at killing the anthrax.

 

            But the thing that stood out for us at Dugway was that a fairly large proportion of the samples that they had irradiated turned out to be positive in their testing, about 20 percent, when we looked at the records.

 

            That should have been a clear indication to people at Dugway that something was wrong.  That number should have been much, much, much lower than that.  There are some other things that are kind of unique to Dugway, including some things that happened in their history.

 

            There was enough evidence for me in the report from the review group that individual accountability should be assessed, but it should be assessed by a formal investigation by an appropriate investigating body.  And the Army has bodies that can do that for us.  Now, the inspector general of the Army, for example.

 

            People deserve due process.  We didn't want to leap to judgment.  The review that we did was a 30 day review.  It was not an in-depth detailed investigative review of the kind you want to have before you -- before you find somebody culpable and take corrective action.

 

            That's what the Army will do now.

 

            MR. WORK:  And so I -- I think you all understand the concept of undue command influence.  It's not appropriate for any of us to -- to speculate on who might be responsible, or even if there is a single person responsible, we will leave that to the investigation to inform us, and then we will take action as necessary.

 

            Q:  Sir, we have time for one more question.

 

            MR. WORK:  Yes sir?

 

            Q:  Yes sir.

 

            What kind of deadlines are under secretary -- is Under Secretary Kendall dealing with now with the new work that you've given him?  And there must be some doubt that no one is at fault, otherwise, why conduct the internal investigation?

 

            And you said though, with -- you said the protocols were at fault and not the employees up here at the podium.

 

            So you slightly contradicted yourself just now by saying that we don't know if personnel are -- it's the fault of personnel or not.  Can you just expand on that, please?

 

            MR. WORK:  Dugway followed the procedures that were in place in Dugway as far as we know, after -- based on just a 30 day review.

 

            As Frank said, what happened were the procedures were the primary culprit.  We believe there were indicators that people should have known there was a problem.  So that is why there was no -- we can say that there was nobody who was doing it on purpose.  They were following what they considered to be the correct protocol, that it was the responsibility of the laboratory to figure out whether those protocols were correct.

 

            That is what the investigation will tell us.  So I don't see there's any -- I don't see there's any contradiction in our position here.

 

            Q:  Things are different at Dugway than they were at the other facilities?

 

            MR. WORK:  Yes they were.  As I said...

 

            Q:  But how could that happen?

 

            MR. WORK:  As I said, there were different procedures in each of the facilities.  They were all in different chains of command.  And one of the findings was -- was that we need to establish a DOD standard as -- standardized inactivation protocol across all four of the laboratories, and that is what Secretary Kendall will have to do.

 

            Now to your point, there is no deadline.  Frank Kendall has as much time to do this and the moratorium will stay in place as long as is needed, with one slight caveat.  At some point, if it becomes clear that it is interfering with our chemical and biological and defense program, then Secretary Kendall will take that into account and make adjustments as necessary.

 

            But his first requirement is to establish these standardized protocols, implement them across the department, tell me that they are scientifically sound, and are very, very high confidence that they will identify problems like this in the future and we'll prevent them from happening again. 

 

            In the meantime, the moratorium will continue.  We will work with the CDC.  Everything is contained inside laboratories.  There was no more shipment of this sample sizes.  There are no more working on it.  So in the meantime, Frank's job is to make sure that these are implemented across the service -- I mean across the department. 

 

            Q:  Implemented without your approval? 

 

            MR. WORK:  No, he will come to me, and he will make a recommendation on when the moratorium should be lifted, and it will be based on science, and it will be based on the best scientific knowledge that we have, using CDC and all of the experts in the Department of Defense to tell us which way they will go.

 

            I will turn this over now to the people who actually conducted the review.

 

            Frank is intimately aware of all of the details.  Dr. Majidi was the actual author of the report.  So if you have any specific questions here, you can ask them.

 

            Thank you very much.

 

            Q:  Can you tell us why Dugway would remain open, given the systematic failure?  Doesn't this suggest that they should not be involved in anthrax? 

 

            These standards that you talk about, they were minimal standards that they applied.  They were using unusually large batches of anthrax, minimal aliquots, minimal radiation levels, minimal testing viability.  And these aren't just arbitrary standards.  They are standards that can be done through math.

 

            You know, how many approximate spores are in a batch.  You know how much radiation needs to be used.

 

            So I don't under -- when we've all asked repeatedly, where was that decision made that you would use unusually high batches and unusually low standards?  And we're not giving an answer on how that decision was made.  And what I don't understand is, who made that decision?  And if Dugway was in the business of doing this systematically for a decade, even though there were warning signs that it was not working, why should Dugway still be in the business of -- of producing anthrax at all?

 

            MR. WORK:  Well, Dugway is not producing any anthrax right now.  They're not shipping any anthrax.  They have stopped.  The moratorium applies to them as well as the other ones.

 

            And I will turn this over to Frank so he can answer your specific questions.

 

            As I said, this was a failure that the Department of Defense is taking full responsibility for, and we need to understand and to establish procedures that will make sure this won't happen again.  I'm confident that Frank is going to be able to lead us to a point where we will be able to tell you and the American public that we have solved this problem, and it will not happen again.

 

            Thank you.

 

            MR. KENDALL:  I'm going to ask Commander Franca Jones to join me up here.

 

            Franca is the chief medical officer for the biodefense program.

 

            And Vahid Majidi, who has been mentioned earlier, led the comprehensive review that the deputy secretary asked me to organize and conduct.

 

            I want to say a couple of things that may clarify this a little bit.  It's about Dugway and about the procedures there.

 

            Dugway did not depart dramatically from what others were doing.  It used the same level of radiation, roughly: lower than some other laboratories, but roughly at the same level.  And there was -- in the report that's available to you now, there are the details of what each laboratory did in all of these areas.  They used a smaller sample size for their testing to verify that the inactivation was successful.

 

            That by itself might not have been enough to -- to -- to cause them to miss at least on the -- with the frequency that they did miss, apparently, the fact that there was still live anthrax in the samples that were irradiated.

 

            They did testing more quickly, probably because of the process they were doing.  They were doing more work in this area than other labs were because of the purpose for which they were doing it.  Also, their samples were contaminated more with other things -- other organisms in other ways than others were, which were more pure, which were being used for research instead of field testing, if you will in laboratories.

 

            So there are some differences that are understandable.  They were -- they existed for a reason.  In general, Dugway's protocols were lower in some areas, and their processes were a little bit different, but they weren't dramatically so.  The group did not find that there was any recklessness on the part of anybody at Dugway.  They did not find that there was any negligence or any gross negligence.

 

            So this is a deeper problem than that.  When I read the report of the review group, what struck me though was that there were indicators that I think that the technical leadership at Dugway should have seen and understood, indicated to the -- and should have indicated to them, that something was wrong, that they need to look more closely at their procedures.  Too high a percentage of -- of their batches were tested positive when they went through the verification test.

 

            And when the review team asked them what that number was, the original answer they got was two or three percent.  But the review team checked the records, and the records show that it was more like 20 percent.  That's a significant difference.  And one of the fundamental characteristics about anthrax and spores and these treatments for spores is that it's a statistical process.  And what you're doing is you're sampling a statistical process.  The technical leadership at Dugway should've fully understood that, and because of that, the implications of having a higher failure rate.  That's what caught my attention when I read the report.  And that's why I recommended a more formal investigation.  What I recommended to the secretary was that the technical leadership and the organizations that are responsible for this, the microbiology organization and the life sciences division, as well as the chain of command at Dugway, be -- be essentially investigated in a more formal investigation.

 

            So hopefully that'll help you a little bit to understand where we are.

 

            Right here.

 

            Q:  Thank you.

 

            Can you explain the moratorium process, how that will affect business going forward, and -- and what it would take, I guess, to lift it even as this process continues?

 

            MR. KENDALL:  In the short term, it will not have much of an effect.  Basically, it -- this is closing down some research for a short period of time.  And some of the testing that we do to verify that laboratories have the capability to test for anthrax successfully.

 

            There is still work going on.  There is still research going on with live anthrax with proper protections for live anthrax.  So this special category of inactivated anthrax, that work is going to cease until we get this sorted out.

 

            There's going to need to be a -- a scientific body of research to more fully characterize and understand how anthrax responds to radiation and how the test to verify that anthrax had been inactivated will be successful in a higher percentage.  That's what we need to do the research on to establish a standard.

 

            I can't -- I won't hesitate to guess as to how long that research will take, but it will not be done instantaneously.  It will take a body of time.

 

            Q:  Thanks.

 

            You mentioned a verification test.  Can you explain what that verification test was?  And can you explain the discrepancy between the two percent and the 20 percent?  Was the two percent something that they had -- the lab said to you, but then you know, was that a -- a lie?  Or was this just a mistake?

 

            MR. KENDALL:  It was a mistake.  I would not call it a lie at this point.

 

            And Vahid, you may want to comment on that.

 

            The team was asked the question, "how often do your samples fail the verification test?"  And the answer was two or three percent.  They went and checked the records, and found it to be much higher than that.

 

            Do you want to say anything more?

 

            DR. VAHID MAJIDI:  That's true.

 

            And the entire dialog that we have at every facility is actually one of the appendices in the report.  So you can see what the actual dialog was.

 

            But it was -- it was a simple misunderstanding on their part, what the actual failure rate was, and when we asked for specific data to support that failure rate, the data showed that it was significantly higher.

 

            MR. KENDALL:  There was also an incident a few years earlier at Dugway in which a -- a -- apparently a live sample had -- had gone through their -- their process, and not been detected.  So they had some earlier indications that they might have a problem as well.

 

            Q:  I'm sorry, and what is -- what is the verification test?

 

            MR. KENDALL:  Basically, after you do the irradiation,  you take a sample from the irradiation and you attempt to grow it.  And if it's alive, and it hasn't been -- hasn't been inactivated, then -- then it will grow and you'll be able to detect that -- that growth.  You put it in a medium.  And one of the differences in procedures was the -- the -- how the degree of nutrition or the type of solution or material that you put the spores in after they've been irradiated, some of the labs used a broth, which is -- has more nutrients, and others use agar, which is a more commonly used substance in -- in work like this.

 

            Out here?

 

            Q:  Hi.  James Rosen with McClatchy.

 

            Deputy Secretary Work praised the Maryland lab that first brought this problem to the attention of the CDC.

 

            My understanding, correct me if I'm wrong, is that it was a contract lab.  And my understanding also from previous reporting and statements out of here is that when it tried to grow anthrax, it was surprised that culture anthrax perhaps, it was surprised that the anthrax grew.  Why would a lab getting what it has been told are dead anthrax spores, why would any lab try to grow anthrax?

 

            MR. KENDALL:  I'll ask Vahid to confirm this, but I think what happened in this case was that when Anthrax is shipped in an inactivated form like we have been doing, it's accompanied by a certificate that indicates that it's not live anthrax.  I think in this case, this lab received it without that certificate.

 

            And because they did not have the certificate, they went ahead and did the test.  Is that clear?

 

            DR. MAJIDI:  That's true.  And this was -- as a part of an acquisition process, so to test the laboratories to see if their systems worked against the anthrax, they were sent blind, inactivated samples.  So they didn't know what the identity of the sample was. 

 

            So in this particular case, they didn't receive the death certificate.  In an abundance of caution, because they hadn't received death certificate, they assumed it was live.  So they sent out to be cultured, and in fact, the culture came out as positive.

 

            Q:  Do we know how many other cases the death certificate was not issued with the sample that was sent?

 

            DR. MAJIDI:  This was not issued on purpose as a blind study for an acquisition process.

 

            MR. KENDALL:  In this case.

 

            DR. MAJIDI:  Yeah.  So it was not...

 

            MR. KENDALL:  Part of a competition.

 

            DR. MAJIDI:  Yes.

 

            Q:  Can you repeat that?

 

            So it was should have had a death certificate, or it should not have had a death certificate?

 

            MR. KENDALL:  Not in this case.

 

            DR. MAJIDI:  No, because it was a part of a blind testing for an acquisition, it didn't have the death certificate, to test the -- the test equipment, are they working appropriately or not?  Can they identify, this is in fact, Bacillus anthracis?

 

            MR. KENDALL:  Right here.

 

            Q:  So it was said at the beginning that these samples went to something like 86 select labs, and I'm just wondering, how select is this process with that many labs?  And are you kind of examining the wisdom of creating this apparatus of labs where you're shipping dangerous pathogens to?  You set up a whole network of these things.

 

            MR. KENDALL:  This was part of a broader program that is designed to protect the country.

 

            We had the anthrax incident that everybody knows about here in the capital of course, but throughout the country, if people are concerned about the possibility of anthrax being used, and if an incident happens anywhere people want to be able to test as quickly as possible to determine if a substance is suspected as anthrax or not.

 

            So a large number of labs would like to have this capability.

 

            You want to add something to this?

 

            DR. FRANCA JONES:  Sure, if I can add -- add one thing, many -- because this was believed to be inactivated, we were not intending to actually use laboratories that may already be registered with the select agent program.  We're trying to grow new partners and technology.

 

            And so for that reason, they were in many cases trying to show that new technologies for detection and diagnostics against anthrax worked, and thus we were sending them an activated material to show us that their technologies would work.  So in fact, we weren't trying to grow the body of laboratories that we use dangerous pathogens.  We are in fact trying to grow the technology basis for our national security.

 

            Q:  Secretary Work said with some of these samples were sent on to second and third laboratories.  Is that correct?

 

            How confident are you that you're going to eventually gather all of these things together?  Are they just going to be missing forever?

 

            MR. KENDALL:  CDC is completing that work.  I think we are fairly confident the laboratories have already been notified to treat all this as live, and that we will get to all the laboratories where we have received a sample.  It's just going to take some time. 

 

            Part of the problem is that this program goes back a decade and more, 12 years.  Some of the records are on paper, believe it or not.  And we're actually still going through some paper records to try to make sure we've caught everybody.

 

            I think we will catch all of the labs.  We're -- I can't absolutely guarantee that, and I'd just refer you to the CDC, who's conducting the secondary and tertiary lab reviews.

 

            Right here.

 

            Q:  I'm a correspondent from Korea -- (inaudible)

 

            I am just wondering about how did it happen?  Failure, delivery failure to -- for example, anthrax was shipped to the South Korea Osan base in the U.S. Osan base.  And so, I'm just wondering about how did it happen?

 

            And second question is, do you have any measures to prevent the delivery failure again?

 

            MR. KENDALL:  It was an unintended delivery.  And it was anthrax that was believed to be inactivated and not live and not able to be grown. 

 

            It went to an Air Force base in Korea to a laboratory on that base for testing  there, and I don't think it ever went and would have gone anywhere else.

 

            So this was a mistake.  As the secretary said, it was a serious mistake.  It should never have happened.  It's an inexcusable mistake.  We're taking the actions to correct it.

 

            Q:  I was -- I'm also a Korean correspondent, of Penang Daily News.

 

            I understand it was a mistake.  Everybody can make mistakes.  But what would you say to those people raised that it was a possible act of violation of international treaty, like the biological weapons convention or status of forces agreement, SOFA agreement?

 

            MR. KENDALL:  I am not aware that there was a violation of any agreement.

 

            There was certainly no intentional violation of any agreement.

 

            I am -- I am not a lawyer in that area, and I can't tell you what exactly the agreement says, or how this would have been affected by it.  But I can assure you that this was an error that happened for a variety of reasons that we have talked about.

 

            And it was done for the best of reasons, to ensure that we are in a position to protect people in the case of an anthrax attack in Korea or anywhere else that we shipped it.

 

            Q:  Did you see any imminent anthrax threat in Korean peninsula?  Is that why you sent it to South Korea?

 

            MR. KENDALL:  Yeah, the concern is about biological attack by others, obviously.  Either terrorist groups or a nation state.  And the threat, unfortunately, of biological attack exists globally for a variety of reasons.

 

            Q:  Last question is are you going to resume the shipments to South Korea once the moratorium is lifted?

 

            MR. KENDALL:  Of right now, there's no intent to do that, and I can't speculate about what would happen in the future.  Anything that we did do, I can assure you though, would be done in consultation with the Korean government.

 

            And there is a -- a task force now working with the Korean government to investigate the specific events that happened at Osan.

 

            STAFF:  Sir, we have time for one more.

 

            MR. KENDALL:  One more.

 

            Go ahead.

 

            Q:  Recently, North Korea announced that they will bring these anthrax issues to the U.N. Security Council.

 

            What is your comment on that?

 

            MR. KENDALL:  I'm sorry, I didn't understand the question.

 

            Q:  Recently, North Korea announced that they will bring this anthrax issue to the U.N. Security Council.

 

            STAFF:  U.N. Security Council.

 

            MR. KENDALL:  I can't comment on North Korean actions or what they're going to do.

 

            I can say that this was brought -- this believed to be inactivated anthrax was brought there for defensive reasons to test our ability to defend against an attack by others.  That's the only reason it was brought there.

 

            Thank you very much.