Brigadier General Malcolm Frost: All right, good afternoon, ladies and gentlemen. Thanks for attending today's press conference.
I'm Brigadier General Malcolm Frost, chief of Army Public Affairs. I will be the moderator for today's briefing on the results of the an Army regulation, 15-6, Investigation into the Inadvertent Shipment of Live Anthrax Spores to a Number of Laboratory and Abroad From Dugway Proving Ground.
This will be approximately a 30-minute on the record press conference. Please state your name and affiliation when asking your question. I will allow one follow-up to each question, and that assumes that your first question was not a three or four-parter question.
Joining us today for the briefing are: Lieutenant General Thomas W. Spoehr, director of the Army Office of Business Transformation, and lead for the Biological Select Agents and Toxins Task Force.
His team included over 80 individuals from over two dozen organizations and agencies within the Department of Defense.
Major General Paul A. Ostrowski, to his left, deputy for Acquisition and Systems Management, Office of the Assistant Secretary of the Army. Acquisition, Logistics and Technology was the 15-6 investigating officer.
And lastly, to General Spoehr's right, is Major General Brian Lein, commanding general of the United States Army Medical Research and Material Command, and he will address components of the way ahead.
Now, Lieutenant General Spoehr will begin with opening remarks.
Over to you, sir.
Lieutenant General Thomas Spoehr: Great. Thank you very much, General Frost. Well, ladies and gentlemen, good afternoon.
In response to direction from the deputy secretary Of defense, and the secretary of the Army, the Army stood up a bio-safety task force to look at biological select agents and toxins from the anthrax incident.
Although that was the impetus for this task force, the task force ultimately made a number of wide-ranging and comprehensive recommendations, which were approved by the secretary of the Army, which will have a general benefit to the entire program as we go forward.
As General Frost mentioned, we set up a biological task force. We had members from all services, so, although you see Army people up at the podium today, we had members of the Navy and the Air Force on our panels.
We began in August, and we will finish this month and transition the remaining work to the Army surgeon general, represented here by General Lein.
Our recommendations, which have been approved by the secretary of the Army include the establishment of the Department of Defense executive agent, who will perform technical review, harmonization of procedures and integrate the inspections for this program. And the Secretary of the Army delegated that responsibility of the executive agent to the Army's surgeon general.
We will establish a standing DOD biological safety review panel, consisting of prominent scientists from both within and outside of the Department of Defense, and that review panel will review and validate procedures for working with biological select agents and toxins.
We have -- we'll put in place -- a process to screen and validate all requests for biological products from outside DOD to see if they are valid and to see if we can substitute a less dangerous product for what has been requested.
We will put in place a central process to track and monitor all requests and transfers, and that includes a new I.T. system, so it will not be at the local level. All these requests will be maintained in a central I.T. repository.
We have disestablished the office known as the critical reagents program, or CRP, and in its place, formed an office called the Defense Biological Product Assurance Office.
We have and are in the process of developing new DOD procedures for the inactivation and testing of bacillus anthracis, which, when the underlying scientific research is completed, and we expect it'll take at least a year, will serve as our single DOD and Centers for Disease Control validated procedure for this procedure.
We have transferred control of the biological laboratory at Dugway Proving Ground, from the Army Test and Evaluation Command to the Research, Development and Engineering Command, and eliminated their mission of producing biological agents for export across our customers. So that production mission will no longer be conducted at Dugway Proving Ground, it will be done at other laboratories within the DOD.
And finally, we've put in place a new DOD biological inspection program in favor of a central program. Previous to this, we had at least eight separate inspection teams. Now, we will have one DOD inspection team, which will partner with the Centers for Disease Control to provide a much more -- less variability in our standards and increased integration.
The totality of all these decisions will greatly improve the safety in this critically important program for both U.S. government workers and the American public. Thank you very much.
Major General Paul Ostrowski: Good afternoon ladies, and gentlemen. My name is Paul Ostrowski, as introduced earlier, and I was the 15-6 investigating officer. The preponderance of evidence with respect to the investigation yielded the fact that no single event, no single individual, no groups of individuals are directly responsible for the inadvertent shipment of a small amount of active anthrax or bacillus anthracis.
We did find, through evidence, that a combination of events, including gaps in science, institutional issues and personal accountability when taken together each contributed to this event.
Let me be perfectly clear. There was no evidence to suggest in any way, shape or form that lab technicians or the American public were at any time at risk. I wanted to be specifically clear on that point. At no time were lab technicians, nor the American public, at risk based on these inadvertent shipments.
With respect to the gaps in science, we have a lot to do. We must investigate the irradiation process, which is the preferred method of inactivating anthrax. We are lacking in terms of the amount of information we've had on spore counts and how that affects irradiation, purity and the type of spore itself, the species, if you will.
With respect to the irradiation process, we are also needing to do additional research with respect to the way that we test for whether or not our spore is active, or was – is not active. Okay, so our testing.
There are numerous different protocols used by the different labs over time that we must get together and conduct additional testing to determine whether or not we have the right process in place to ensure that our spores are truly inactivated, based on the irradiation process.
Finally, we have to take time and investigate a theory with respect to spore healing. There is belief out there that in order for a spore to grow it must first heal. Traditionally, we have taken spores from irradiation right into growth in order to test for viability.
In the future, the intent is to spend time and investigate spore healing, which is a process by either a freeze/thaw cycle, potentially, or allowing the spore, at a certain temperature, to heal, or any other time or other method that will allow a healing process to occur, because a spore will not grow unless it heals. So more time is necessary, and more research is necessary, in that particular area.
Institutionally, we have to take a look at how we inspect our facilities. Right now, there's one standard protocol. There are three types of inspections: federal inspections, which are run by the CDC; Army biosurety ... inspections, which are run by the DAIG -- Department of the Army Inspector General; and then also Army safety inspections.
Specifically with respect to Dugway, since it was a producer of inactivated antigens, we have to take a look at specifically inspecting that process.
In a production process, we want repeatable results, documented over time. We need to make sure that our inspections live up to that. Our inspections should be not announced so that we ensure that we go into a scenario where we see the lab working as it does on a daily basis.
Finally, with respect to individual accountability, we saw failures to take action. We saw best practices by lab technicians not being used, and so the intent is to ensure that the Secretary of the Army and the leadership of the Army has an opportunity to adjudicate that.
Pending your questions, ladies and gentlemen, that's my opening remarks.
Gen. Frost: Okay. With that, we'll go to the first question, and we'll go to Reuters for this one.
Q: Sure. I had a question about the accountability. So the report says several individuals, including, now, Brigadier General King, should be held accountable. What does that exactly mean? Specifically, how would they be, or how should they be held accountable?
Gen. Ostrowski: It is beyond the scope of the 15-6 officer and the 15-6 investigation to delegate, or I'm sorry, to decide, what happens to the individuals that should be held accountable. The 15-6's responsibility is to clearly point out who should be held responsible, who should be held accountable and who should not be.
It is then up to the Army's chain of command to invoke any kind of retraining, counseling, or any other type of accountability for those particular individuals. And again, let me be very clear -- when we say held accountable, it doesn't necessarily mean remove and replace. If we have a situation where we have an individual that needs to be retrained, I will say he needs to be held accountable for retraining, okay? So the point is, is that it runs the full gamut, and that's why we have a chain of command who will take a look at the actions of these individuals and adjudicate same.
Gen. Frost: (off-mic.) Next question?
Q: So is Army leadership looking at this now then? Has it been passed along and what level is that? Is that executive of the chief, or?
Gen. Ostrowski: It goes to the Secretary of the Army and that he has the opportunity to act or delegate.
Q: And can I ask you something about your -- in your opening statement you said there were no workers or individuals ever in danger. How, can you explain how you can be so confident that no one was ever in danger?
Gen. Ostrowski: Sure, number one, it was in a Biosafety Level III laboratory so the personnel used their proper protective equipment with respect to that laboratory at all times. And so from an individual technician perspective, they were not risk. So, that's again, working in those particular environments, our personnel are equipped with personnel equipment to deal with those kinds of bombs. And that's why I can be assured and history has shown, through the fact that none of our workers ended up sick as a result of this, that there was little chance, or no chance, that there was a risk to those particular individuals, those lab technicians.
Q: So it not because they weren't exposed to anything. It was that they were prepared in case they would have been exposed in advance?
Gen. Ostrowski: That is correct. In each one of our labs and Dr. Lein will certainly jump on this, our personnel are always equipped for the particular biosafety level, and adhere to those policies to ensure that there is as little risk as possible with respect to their health.
Q: And you're certain that no one was exposed outside of the labs because of the way that the manner in which the samples were shipped, or?
Gen. Ostrowski: That's correct. They -- this is not again, this is not powder. It was, number one, shipped by a very secure means as secure as we can for an invirulent or inactive strain, first of all; second of all, it was shipped in a liquid vial. Okay? So again, not aerosol. Anthrax or bacillus anthracis, is mostly placed in an aerosol venue.
These were shipped in containers that had liquid.
Gen. Frost: Next question.
Richard.
Q: General Spoehr, can you say that basically, that this is over? I think the last count that we got was something like 100 live spores or questionable samples went to 184 labs, all 50 states, nine overseas countries. Is that the final count or are you still looking for more places where this may have gone?
Gen. Spoehr: We have a very high degree of confidence that we have identified all the recipients. I don't know if that there is ever the potential to achieve certainty, because what we have found in some cases, people that received shipments chose to separate a little bit of that and send it to a third-party if you will. But we are -- we have tracked down all the primary recipients and we have done everything we believe possible to notify the entire community of what is occurred here, so we believe with a very high level of confidence we have found all of these samples and they have been destroyed.
Q: And sir, if I could, Dugway -- he spoke about eliminating the mission. Is the idea to get that started up again? Is the idea what happens to all the personnel there? What was going on?
Yes, that happened. A good question. If I said eliminate the mission, I misspoke. There -- what is being eliminated is their production mission, and what that means is they are producing more than what they need for their own internal use.
They will still be testing and they will still be testing materials against some of these biological organisms. But they will just be doing that further internal Dugway use and not shipping organisms or materials anywhere else other than for use of Dugway. And we need that capability. This is a capability that our nation needs to keep testing these materials.
Q: A capability that the nations needs. So at some point or another, it's been shut down now, right? You're not shipping.
Gen. Spoehr: We're not shipping, nor are they even working with biological agents today.
Q: Okay. But the intent is to start this up again. And the purpose being what?
Gen. Spoehr: Yes, so again, they will only be using -- they will be only working with materials for their own internal use, but they will be making, storing biological organisms to test U.S. equipment again. So for example, a detector, which we believe detects against anthrax, it's shipped to Dugway and they under the proper precautions, test it using the actual agent. You can only do so much with a simulate or a surrogate. It's -- by -- at some point, you have to test the equipment with the actual agents to make sure it protects soldiers and service members.
Q: (inaudible) -- with the (inaudible). Do you have any -- (inaudible) -- investigation of Osan Air Base in South Korea about the anthrax issue?
Lt. Gen. Spoehr: I did not look at that, ma'am. I don't know if General Ostrowski did.
Gen. Ostrowski: No, ma'am. I did not look at that either. That's beyond the scope of my investigation. My investigation was focused directly on Dugway Proving Grounds and Dugway Proving Grounds only.
Q: (off-mic.)
Lt. Gen. Spoehr: What we have done is put a number of procedures in place for how we deal with customers outside of the DOD, or even within the DOD, and so there we have totally revamped the processes and the procedures for which we will deal with customer requests and to make sure that we have a high degree of certainty that what they asked for is what they need and what they need is what they actually get. So we're putting a whole suite of procedures in to ensure those type of things take place.
GEN. FROST: Any other questions? Yes?
Q: Thank you. Carla Babb, Voice of America. I was interest in -- you said that the -- the science off a little bit and I was reading how it says that only way to guarantee a sample is to test 100 percent of it to make sure it's not viable. What other ideas, what other tests are you guys looking into using if this test is not accurate anymore? And how long was the Army using this test?
Maj. Gen. Lein: So that's something that we are going to be looking at that as we assume the responsibility for the executive agency over the biologic select agents and toxins, and certain generals are responsible official for that.
We have to look at the science based upon the newer capabilities and the newer technologies and how to test. If you irradiate something so much it destroys the cell, it destroys the proteins, it destroys the markers, so then if you try and test for that live agent, it's not there. If you use it too little, then you have agents that could potentially come up.
And so what we've got to do is determine what's the -- what is the risk associated with certain levels of irradiation to the cell? Can we replicate and use those specimens in testing for medical countermeasures, for vaccination, for vaccine production and all the rest of that stuff? How do we do that, and then how do we risk stratify? And are there other, newer tools that are out there that perhaps freezing -- super freezing or using different types of radiation rather than gamma radiation? That's going to all be part of this in-depth research that we are doing in conjunction with the CDC to develop a national standard of what is determined inactivation of anthrax and still be allowed to use. And we're not going to do this with just anthrax. Obviously, anthrax is the focus of this, but the requirement on us is to do all of our biologic select agents and toxins, anything that we're going to be shipping out we've got to validate and determine is the mechanism that we're using actually inactivating it to a level of surety that we can provide to the public and to everybody else that what we're shipping is safe and is not going to cause a challenge if it either gets into the wrong hands, inadvertently spilled, or the specimen is lost. That's our requirement is to ensure the safety and transparency of this process.
Q: Are you working with the CDC on this research now? Or is it something that's going to be started in a few weeks?
Maj. Gen. Lein: Yes. So, I've already met with the CDC twice. I've been down there personally twice. And then later next week, our scientists are going down to CDC to start laying the groundwork of what this is going to have to do with -- with anthrax. And then as the -- as we stand up this review panel, this peer review panel, the priority focus areas are going to be those select agents and toxins that we are going to be using to ship to other places, that we have got the surety that those that we are shipping are inactivated. And then we'll look next at the ones that we're producing internal, and then finally those non-biologic select agents and toxins to make sure that they are actually non-biologic select agents and toxins.
Q: And just to follow up on the second part of my last question. How long had the Army been using that testing when shipping and working with anthrax? Can you say whether or not it was active or inactive?
Lt. Gen. Spoehr: We can see it at least as far back as 10 years. And our dilemma was that each lab's procedures were just a little bit different, all within the range of what scientists believe was reasonable, but all a little bit different as well.
Gen. Frost: Let's go to Jennifer -- (inaudible).
Q: In the process of your investigation, did you find that any other agents, dangerous toxins had been shipped inadvertently in a live state? Did you find that this was happening with agents other than anthrax?
Gen. Ostrowski : I had not found any evidence of that to be the case. I will tell you that my investigation was narrowly focused on Dugway and bacillus anthracis with this particular event, with lot 1667. We were made aware obviously, you all know -- with 194 labs received bacillus anthracis that was live. That did not come from lot 1667. That came from lots that had -- we went back in history. We went to the archives, into the freezers of everything that we had at Dugway. And what we were able to find is 33 separate lots since 2004 that we had thought had been inactivated. We pulled all of those 33 lots. And we tested them. When we tested them, 17 of those lots were able to grow, which shows, again, that the type of procedures that we were using were flawed in some way.
Now, let me be extremely clear here. As Dr. Lein talked about just a few minutes ago, there is a very fine line of what it is that we're trying to do. If you can -- what you're trying to accomplish is a death to the DNA within the spore. But you have to be able to save the antigens and proteins, otherwise that spore is worthless with respect to our ability to work with it in a B.S. Level Two lab, i.e. a downgrade from a B.S. Level Three. So that we can have accredited and registered and certified labs work with it at a much lower level.
The problem is if you radiate it too much, you kill all the antigens and all the proteins. And so that spore is worthless. At the same time, if you don't irradiate it enough, you have live spores. And we're talking billions of spores irradiated at the same time. So that gets into that strain that I was talking about. That gets into the spore count and the purity issues that we need to go back and get that science done in order to better inform of us whether we're doing things right.
Q: Hi. (inaudible).
This question's for Major General Ostrowski. Were you -- so you're focused strictly on safety of Dugway. But, can you say that no scientists that were working with spores in foreign bases in all of the bases that accepted spores in the U.S. were possibly in danger being in contact with a live spore?
Gen. Ostrowski: I certainly can't say that based on the very narrow focus of what I was asked to do by the Army. Again, I think that the -- the labs within the Department of Defense and the labs that we work with throughout the commercial marketplace and everywhere else -- okay, they are registered and certified for a reason.
They have shown the credentials necessary in order to be able to work with this type of material, and Dr. Lein can speak to it probably better than I, but there's a reason why these labs are accredited and they're certified and they have to follow the procedures associated with that accreditation and certification process. So to say that we are, that we may or may not be working with -- with agents that could be infectious -- we absolutely are, okay? But the intent is to work with agents that are infectious at the right biosafety level -- i.e., level 3 or higher -- whereas if you're working with inactivated or invirulent strains of spores, then it can be worked at a much lower level -- BS level 2 lab, for instance. I hope that answers your question.
Gen. Frost: Okay. Last question, please.
Q: Thank you.
My name is Hiroaki Wada. I'm with Japan's Mainichi Newspaper.
My question is about whether you informed the governments of the countries that received these spores about the result, and what kind of reaction did you get from them? And, if you haven't done that, do you plan to do that?
Gen. Ostrowski: With respect to this particular investigation, we just rolled this out, as you all know, within the last 24 hours, and so the intent is to ensure that those that want this information obtain this information.
That's why we've hung it on the Department of Defense FOIA website. It is out there for all to see, and the intent is to ensure that we are completely transparent with our findings and that we show that we have done the due diligence.
I had a 10-man team. We interviewed over 69 personnel throughout six months' worth of time, and there's been a huge investment on behalf of the Army. Let me make it clear: the reason that the Army does 15-6s is to make our Army better. We see a problem, we do an investigation in order to determine what -- what happened, and then we get better because of it. And that's the reason why we do these 15-6s, and that's our intent to ensure that what happened in this event doesn't happen again.
Gen. Frost: And if I could say any notifications would not be made by the Army. That's something we would defer, bring up to OSD, and they would work it through appropriate channels, and -- and so that's where I would refer you to for that.
Okay, ladies and gentlemen. Thank you very much. Appreciate it.
I just want to let you know that you do have the media release on your chair. The redacted 15-6 has been hung and is available through the Media Relations Division of the Office of the Chief of Public Affairs of the Army.
And also, if you have any queries -- any follow-on queries or follow-ups, then I'd ask you to come see Army -- see OCPA media relations division. Lieutenant Colonel Jesse Stalder is the point of contact. Do not, please, go to Dugway. Don't go to ATEC.