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As we look at our needs in this area, we need to ask ourselves: What is an appropriate level of sensitivity and specificity for these tests? How often can we be wrong at the expense of being right?
There's a need to validate these assays, make sure that they're reproducible. And in many ways, the parallels between good diagnosis and good prevention and treatment show us that there is a substantial amount of work to be done in both of these areas of the development of medical countermeasures.
I'd like to touch on certain issues in food security because they are so closely--they're similar to what we have seen with the development of clinical diagnostic assays, and that is, we need to understand how to detect these biological agents in various food matrices which are numerous and varied. How well do these pathogens survive in a given food matrix? Can such a pathogen cause human disease following oral ingestion in this food matrix? What's the relevant inoculum causing clinical disease?
Again, these are questions that are currently of great interest and the subject of a fair amount of activity that we need to develop.
Lastly, I'd like to touch on some issues in radiation safety. This is a little bit different because this is an area where, as a public health community and as a government, we have decades of experience. In fact, decades ago, this was an issue of tremendous interest and tremendous public health preparedness.
In FDA, we maintain expertise in radiological public health. We have experience with population dosimetry studies from one of the largest sources of radiation to the general population, that is, medical X-rays, and as I mentioned earlier, we have a role in radiation response.
The maintenance of a workforce with these kind of skills requires a combination of scientific credentials and on-the-job training. There is some recognition that these kinds of individuals who were very much in demand decades ago are starting to retire. It's not clear that we have identified the sources and the means for maintaining this workforce. And we need to start looking at where this kind of resource is being trained, what are the programs out there, how are we going to identify our next generation of radiation safety workers.
The expertise that the country has had in nuclear and in radiological events may serve us very well, and at the same time we need to be positioned to think very broadly about how radiation exposure might come about when the element of the human imagination is introduced into these kind of risks. What we had traditionally thought were the categories of risk to think about may need to be expanded depending upon what someone might think is an appropriate medium in which to slip a radiation-emitting material.
So, again, we are looking at a strong regulatory precedent, but a need to maintain that and stay light on our feet when we try to understand the breadth of problems conveyed by new risks associated with terrorism.
By way of conclusion, I think what I'd like to show is the balance we seek to strike in our efforts in counterterrorism. As an agency, we have a mandate to see that any of our regulated products meet a standard of purity, of safety and effectiveness, and are available when they're needed. In a public health emergency, such as would be presented by a terrorist attack, it's imperative that there be a rapid availability of these regulated products for large-scale use.
The agency's role in counterterrorism is to see that this availability need is met for pure, safe, and effective products consistent with our legal responsibilities as a regulatory agency.
Thank you very much, and I will be happy to take any questions.
DR. LANGER: Would you like to do questions now or after Joe Levitt? What's your preference?
DR. MEYERHOFF: I am happy to wait if that--
DR. LANGER: Anything is fine. So we'll wait. Good. Thank you very much.
So Joe Levitt will talk about food safety and the counterterrorism initiatives.
MR. LEVITT: Thank you very much. A pleasure to be here. Let me begin by thanking the Chair for your distinguished service as Chair of this panel and welcoming the new Chair. We look forward to the seamless continuity that we know will occur.
I reflect back to the first time I addressed this Board several years ago following the Science Board's review of our Foods Program. We provided a lot of good suggestions, and today we are well on our way to making a lot of progress there.
Understandably, that review did not really address counterterrorism, that not being broadly on our agenda at the time, and so we have a lot of new information this year.
I think probably my first main point is that today, about a year after the terrorist attacks, while a lot has been done--and you'll see a lot has been done--we also now have enough distance to really see how massive an undertaking this really is and needs to be.
Interestingly, in today's Washington Post, for those of us that had time to get past the detailed description of the sniper apprehension and so on and so forth, on the front page there is a report of a major bipartisan panel on counterterrorism. This panel, for those that didn't see the article--and I didn't know anything about it until I saw the article, so don't worry, you're forgiven--was chaired by former Senators Gary Hart and Warren Rudman. It had such distinguished membership as George Shultz and Warren Christopher, former Secretaries of State; former Chairman of the Joint Chiefs of Staff, William Webster, former FBI and CIA Director; and Harold Varmus, former NIH Director. And the major conclusion from that report is that, "The task of protecting the nation is so complicated and expensive that the government's multi-billion-dollar efforts will barely dent the problem."
That's kind of a staggering statement and a sobering statement, but I can tell you, for somebody who has lived it from a inside-the-FDA standpoint, it rings true.
My third point is that--and I will periodically come back to this only because I can't help myself. While we have done a lot of planning, a lot of exercises, a lot of laboratory work, we had our own little version of on-the-job training during the anthrax episode of a year ago, not because of the fact that food was affected but the fact that our building was affected. And when we were downtown at FDA--we've since moved up to College Park. Because of our proximity to the Brentwood mail facility and the triage of testing mailrooms, we were among the first mailrooms in Washington to be found to be called "presumptively positive" for anthrax. That was on a Sunday night. Because that was the front end of what we're now calling the need for surge capacity, it took almost an entire week before we found out on Saturday, confirmed from the Centers for Disease Control that, in fact, it was negative. But it was one hellacious week, and during that week, in retrospect, I can tell you, we learned a lot about what it feels like to be a victim as opposed to just somebody on the scientific end, learned a lot about risk communication, and in retrospect, I think it's been a valuable part of our emergency preparedness.
With that, let me go to what I want to talk about. I'll describe some of our general main messages, the activities we've undertaken, some areas of special attention, and some conclusions.
I think, first of all--and this was one of our first insights about a year ago--was that we're not starting from zero; that, in fact, we have a good start; that the systems that have been put in place to reduce foodborne illness, those systems being the surveillance system through CDC, the FoodNet and so forth, the prevention systems we've put in place, HACCP, good agricultural practices, the emergency response system that's been drastically improved, including the advent of the PulseNet and the DNA fingerprinting--those are the same systems that will help us preventing and responding to a terrorist attack.
Indeed, when you think about it, if there is an outbreak of foodborne illness, you don't know in the beginning whether or not it is accidental or intentional. We've always assumed that it's accidental, but now we realize it could be intentional as well. But in the beginning, you're not going to know, and those same systems are going to be the ones that we're going to need to depend on.
We've already realized that especially critical is we need to do what we do best. We need to continue to rely on science-based approaches to solving these problems. And if we do that, we do feel we can make a lot of progress.
Now, let me describe what we've done. We very quickly put together what we call a short-term, medium-term, long-term plan that divided our activities into three simple notions. One is anticipation. To what extent can we do risk assessments, threat assessments, to anticipate what is the highest areas of likelihood that food could be used as a terrorist vehicle? You know, nothing is for sure, but to the extent that we can anticipate, we should.
Second, we know we can't anticipate everything, and we're going to have to be sure if something happens we can respond effectively and immediately. But over the long haul, just as with food safety generally, the more we can put in place prevention/deterrence systems, the better off we will be in the long run. And so we have gone through and tried to flesh these out, so let me do that for you here.
Starting with anticipation, one of the first things we found out--it's interesting, the things you learn in times of unexpected occurrences. While Dr. Meyerhoff is right we're dealing here with a lot of exotic agents that we've not been talking a lot about recently, nevertheless, we have a lot of people with a lot of experience. And all of a sudden you hear, you know: I worked on anthrax 20 years ago; people told me stop working on its because it wasn't relevant. But we found we have people with a lot of experience, a lot of expertise, and we put together special teams to do a series of risk or threat assessments across the food supply.
We used a model that we obtained from the Air Force, you know, under the good slogan, "Good luck beats good planning any day." In the Air Force Reserves is a gentleman named Larry Barrett, who also is in the Department of Public Health in California. He got called up in the Air Force to put together a food security plan for the Air Force. Pilots eat, too, and they want to have safe food. And immediately because of his civilian work, he realized that the applicability of what he was putting together would have direct applicability to us. So he immediately went to his Surgeon General and his superiors and figured out how to declassify or sanitize, whatever the right verbiage is, and shared with us the system known as operational risk management, which basically looks at a combination of severity and probability and tries to match where is the greatest chance for the greatest harm and really focus there.
We used that system, and we used a three-part process looking at the food, the agents, and the place in the food chain.
Now, it sounds kind of silly, I will confess, but the way we all remember is to think back to the board game Clue. Everybody remember Clue? Colonel Mustard with a wrench in the kitchen? Well, you got to know your food. Are you you're dealing with mustard or plums? You need to know your weapon. Are you dealing with anthrax or are you dealing with smallpox or what? And you need to know the place, especially in the food chain with so much food processing, what agents are going to be killed by pasteurization and which aren't. What happens at the end of the system is different from what happens at the beginning.
And what we found is that it's also a good triage system, because almost any food can be tied to some agent, and almost any agent can do some harm somewhere. But once you start putting all those three together, you can start refining what are the greatest likelihoods.
And we put together a panel of experts from FDA, from the Center and from the field, and we came up with a series of threat assessments internally. That process is now being validated externally by a group through IFT.
Interestingly, one of the things we've learned--there's also reference in this news article--and that we're not used to is the fact that a lot of this information, while really sought after, also needs to be really carefully protected. The watch word is don't give the terrorists a road map. And so those threat assessments, no sooner were they written and we presented them to the department leadership, they were immediately classified. And you know what that meant? The people who wrote them could no longer read them. But don't worry, the safe had them, and they were safe. They were safe from the terrorists and safe from all who could use them, beneficially or un-beneficially. I saw that obviously sarcastically. It was an area of major internal debate and frustration.
A year later, I can tell you we've put a lot of people through the clearance process, and so now the people who wrote them can read them and can use them to our benefit. But one of the things that is new that we are not used to is the notion of secrecy versus the need for openness. And it presents major challenges, I can assure you.
At the same time, or actually before--and we actually had this going before September 11th, although not by much--we had a contract scheduled Battelle to do a similar kind of threat assessment from the outside. We got a progress report on that in the spring. We made some additions and adjustments, added our own experiences, and that final report is due out in December. And so we'll have the benefit of that.
Also under the area of anticipation is better intelligence gathering. You know, I now say all the time, because it just seems so odd to me, that, you know, as CFSAN Director, I never thought I'd stand up before a group and say we need a closer working relationship with the CIA. I mean, who can imagine such a thing? And yet obviously that's now true. FDA is fortunate, through our Office of Criminal Investigations, we do have very close ties through to the intelligence community, the FBI, and, again, once you get the right security clearances, we can get that kind of information. And yet I can tell you even from the intelligence community, this is not the kind of information they're used to collecting. And so this is some new areas for them as well.
So, number one, anticipate what we can.
Number two, respond to what we must. This is probably where FDA historically is at its best. We have a lot of history of responding to emergencies of all kinds. In this area, I'm thinking back to the Tylenol tamperings. We have applied that. We have conducted under Alan Morrison's leadership a number of emergency exercises, and some the FDA leads, some the department leads, some USDA leads. But there is a lot of effort going into it. I can tell you they are sobering exercises. Each time you learn a lot, but you also realize how many things can happen.
One thing that we learned from the anthrax episode, I can tell you both internally and just watching, is the laser-like focus by the media. You know, when you have a foodborne illness outbreak, while, as I said and it is correct, we're responding quicker than ever, nevertheless, it takes time to do the epidemiology. By and large, these things are, you know, subterranean. Nobody knows they're really going on, and only at the end when we announce the recall, ah, you know, the government did its job.
Well, if the media were following us hour by hour, like they were during anthrax, like they were during the sniper episode the last three weeks, you know, it's an entirely different story. And so when you go through these exercises, it is a sobering experience of how much there is to do and how important the work is. But we benefit each time.
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