Food Safety Counterterrorism Initiatives

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MR. LEVITT: Obviously a good question. The answer is, that's a work in progress. That's certainly our goal. And you need to also add in there what you know in terms of triaging from where the food is coming from in terms of what are hot spots. This goes back a little to the threat assessments that I described that we did that were actually designed to do that. When we locked them in the safe, it became harder to do it. We now have more access to the safe, and so you're going to see more of that rolling out. And because even though we have increased--this will be confidence inspiring--we've increased the sampling from 1 percent to 2 percent. That's why we say we doubled and doubled again. It does sound better.


MR. LEVITT: But we're never going to have high percentages. That's why targeting, triaging, stratifying is the key to be able to do this. I think in its first phase, to be honest, more effort has been gone just getting more people out there, getting them trained to know how to do this. As we gear up there will be more triaging. As more intelligence information comes in, we'll feed that into the system. Part of the new IT systems I describe for registration and prior notice are really part of an ongoing upgrade across FDA through ORA, through Regulatory Affairs, to upgrade our OASIS system, which is the historical import system we've had that itself tries to triage our internal, our domestic information that we have. We're trying to get that all brought in together so we have, if you will, a centralized, computerized brain of information that can help triage.

In terms of the laboratories, the ability to follow up on the threat assessments will depend on having the right methods, the right laboratories, the right capabilities. So we will phase that in based on what we do have. But it will be some time before we have all really the right tools so that the work at the border--that's really the bigger picture. I think last year while we were putting together the appropriations, during that time of enormous intensity, I guess what I learned in retrospect, in times of enormous intensity, you get one message. And the one message that got out was FDA doesn't have enough people at the border.

The concomitant, which were I to do it over again, I would have found a way to package two halves of one message, is you've got to have the people, you've got to give them the tools. And the scientific tools, which is what you're referring to, is something that the funding was, you know, not proportionate by any means, and something that we're really trying to focus on in coming areas.

There is some opportunity, assuming the 2003 budget goes through. The National Institutes of Health have received, from an FDA perspective, an enormous amount of increased bioterrorism funding. Some of that may be an opportunity for us, because they do have an area--we were just briefed a couple weeks ago--they have an area for diagnostics. And while they were thinking originally human diagnostics, as we talk to them, they understand the point that you need to be able to have the diagnostic for the food as well as for the person. And so those of you from academic institutions, the FDA cannot apply for those grants, but it's something we'll be working on getting the word out that that is an area to try and tap into.


DR. DAVIS: You mentioned Category A agents in particular, but of course, as far as the food supply and certainly for things by the oral route, Category B and C have the agents that are actually of far more concern perhaps than even Category A if you're going to swallow things. Can you comment on where you are in terms of the full spectrum of those categories?

DR. MEYERHOFF: Sure. I would say two things. First of all, the entries on Categories B and C are lengthy, and as you very appropriately point out, are often more of a threat to food than some of the really high visibility organisms I put in Category A on the slide. And truly what we know historically about what has been introduced into food intentionally in this country has been the more garden variety good pathogens. I think particularly of an event each with salmonella and shigella.

The second comment I would make is currently we in the federal public health agencies that are looking at this, are starting to work through Lists B and C, and they are getting a lot of attention right now, both in what belongs on the select agents lists and how we're going to approach dealing with those bugs. So they haven't been neglected, but rather left off of my presentation more for the sake of showing what are some of the highest threat agents.

MR. LEVITT: If I could just add to that. From the food perspective, what we're calling the traditional agents like salmonella, E. coli, listeria and so forth, we're more comfortable simply because we have more experience, we have the tools, and we're more just better prepared to deal with that. But one area, now that we think back to the food safety activities over the last several years, one of the areas that was really missing was medical countermeasures. There really was not a lot of interest or attention to medical treatments for food poisoning, and I think that may be one positive side effect of this now that people are thinking of medical countermeasures. Before it was simply find it, bring them in, give them antibiotics and go home. Now there may be more interest in dealing with some of the medical countermeasures that weren't really in the medical arsenal before.

DR. DAVIS: That's somewhat, you answered one of the questions that I was going to pose. $159 million didn't seem like a lot of money as you listed out all of the things that FDA was going to be involved in, et cetera. It seemed like a drop in the bucket. And even though NIH may be getting a lot of money that you say you may be able to piggyback off of. Obviously, when it's other people's money they get to drive the program, and their interest and yours may not lie along the same length. So that was one thing.

But the other thing that was mentioned about the availability of nonhuman primates to potentially do some work, clearly, that takes a lot of money. My business in drug development, we're always scuffling now with the availability of primates to do normal drug development. So to have someone like FDA out there using those same resources, that's not something that's going to be doable in a quick fix kind of thing. And so you'd have to be a sustained user in order to increase the supply, and that again will take I think a lot of money. And so my concern was that 159 million, sounds like most of it is going over to people to do the border work, which I'm sure is necessary, but how do you get the rest of that done, and what do you sacrifice? What else isn't being done in order to do this new work? It just sounds like there are a lot of activities that you have been engaged in in the last year, so what hasn't been done?

MR. LEVITT: Well, let me kind of go back to, for better, for worse, the world of the federal budget. And I guess one I've learned is that it is very difficult to break out of historical norms. The FDA is, by federal agencies, is a small agency. And a lot of budget talk is in percentages. And so while we joke and say we'll just take 1 percent of the NIH budget, we're not allowed to talk in those terms. You know, a 10 percent increase in the FDA budget is like what more could you possibly want? And so the FDA, that's part of our world. As a second part of that world, in the food area, there was a GAO report, by now a couple years ago, that pointed out that the FDA has 80 percent of the responsibility in food regulation, but 20 percent of the resources. So along comes the Bioterrorism Bill. They do appropriations. The FDA got $100 million for foods. My gosh, you broke out of that mold. Well, USDA got 400 million. You know what that is? 80/20.

And so somehow the system does not break out of traditional modes. We constantly fight against that. If you have any ideas, but I would just tell you, that is a nature of the system. I was--I guess even I took a step back when I heard a presentation from NIAID, where a lot of bioterrorism money has gone, appropriately. Their increase, increase at one institute, a big institute for '03 if it's passed in the President's budget, is 1.75 billion. The FDA budget, not the increase, the FDA budget for everything we do is less than that, a little less than that. It's the same ballpark. What are we at now, 1.6 maybe, 1.6 billion. So an increase is greater than our entire? What that tells us is that one, we have to keep making the case, but we also have to realize we have to really go to leveraging. We have to be good at working with programs that are elsewhere. We cannot think of it simply as the FDA is an isolated island. And a lot of our work is based on working with USDA, with the research that's done internally at ARS over there, extramurally through CRES [?] and tapping into NIH funding and working with universities. That is part of who we are and how we work, because I think the other, if we think we can do it all by ourselves, I don't think we'll ever get there. In terms of what is not getting done, we worry about that all the time. I can tell you that we all feel that the food safety work that had increased for several years, has--I would say that momentum has paused. We haven't lost the momentum, but it has not continued to accelerate as it might otherwise have done. We do need to respond and are doing incrementally more work in areas like food allergens. The TSEs is an area that is getting more attention.

But you are absolutely correct, at some point there is only so much in that box to give. And what we keep looking for are areas that we get a two-for out of. When we put somebody at the border, they're not just looking for anthrax. They're looking for additional agents. They're looking for the same work we've also looked for, so a lot of it does go for both, but you raise important points

DR. MEYERHOFF: I'd just like to add a couple of things to Mr. Levitt's remarks. On the issue of leveraging on the medical countermeasures side, I think recognizing that NIAID has been very well recognized as a place where the research dollars are going to go for the development of research and new products, we work very closely with them developing criteria for animal models and looking at what needs to happen to study these new products, vaccines, immunoglobulins, drugs.

Yesterday I was listening to some remarks from Dr. Fauci, and was very interested to hear what a large proportion of their efforts are going to go towards product development. They are looking for deliverables that I think we, as the regulatory agency, will be deeply involved in.

Your comments about the primates I think are very well taken. One point I want to make explicitly because I'm not sure I did in my remarks, is that we are not so much seeking to have animals on which to work in our laboratories, although we do do some of that, but rather, I think because we think see the breadth of product development, we understand how many different products are going to need primates. And I think we need to collaborate with the academic community, with industry, with the other federal agencies that are working on this to recognize we have a limited resource, we need to figure out what comes first and what comes next, and make sure that we deploy it in a way that serves all of these needs. So, yes, there's a shortage of those animals and it's going to take a lot of organization to figure out how to use them best.


DR. RIVIERE: Mr. Levitt, following up on this increased vigilance at the border, did you find out anything with that? I'm curious because the sampling has always been so low and now that you have an increased presence for non-bioterrorism type of problems, have you come up with anything that was a surprise or--

MR. LEVITT: I guess I'll ask John to see if he has more specifics on that.

MR. MARZILLI: Yes. The first thing I want to mention about the increased vigilance on the borders, I know a lot of people probably came in through National Airport or Dulles Airport this morning when they arrived here, and they were greeted by folks from the TSA. That's not the kind of employee that we have at the border.

First of all, the folks that we hired in the counterterrorism hiring and in our additional hiring, are all folks with science degrees. Most of them have experience. Just f.y.i, the average age of these 600 employees that came in was 36, so we have a lot of people with a lot of experience. These folks are not strictly deployed at the borders. That is their home station. That's their home office. But these folks will and are also conducting domestic inspections at the plants where these products are further manufactured in the United States, and going overseas. So they will be going overseas to do inspections at overseas that manufacture products for here.

Yes, we have had a number of very interesting cases this year in terms of folks that were familiar with products, and just having hundreds more people on the border as a border presence, looking at these products come across, could be things as simple as the person conducted an inspection at pharmaceutical plant X and new what the raw ingredients were that were going into that firm. Yet, they saw an entry coming into the country that didn't look anything like the drums of raw materials that were destined for that firm. That makes a completely well rounded investigator that we have there on the border. And as I said, all of these folks are folks with science degrees, and we have had a number of interesting cases this year, and even things as bizarre as crates of product coming in with something sprawled on the side that says "Osama is our hero." I mean things like that, having people there has made the difference, and having product testing done at the border is additional work that we're doing as well.

DR. RIVIERE: Well, I guess the question is, is the sampling before was relatively sparse, and I'm wondering if that's increased now because there's increased testing going on pretty much to those predictions that were holding before as to incidents that carry through. In other words, were there any surprises? Were you all of a sudden finding an increased level because of more people looking in say a specially specific commodity area, an increased presence of either bacterial contaminant or chemical contaminant? Are there increases again of chlorine pesticides coming in?

MR. MARZILLI: Actually, that is a very good point because we have--as Joe has pointed out, these efforts are dovetailed with our domestic efforts, so we have had more, quote, "hits" in terms of some of the pesticide problems that we've found and some of the pathogens, not only natural pathogens but the foodborne pathogens that we traditionally look at. So we are getting a lot more surveillance. As we're implementing these counterterrorism efforts we're getting a lot more surveillance on the front in terms of food safety and safety of other products as well.

So, yes, we are finding--we're getting more information. We're honing in on more products. We're able to do more blitzes as a result of it, just because of the intelligence that we're gathering.

But, yes, we have had increases in pesticide residues, increases in finding products with some contamination from heavy metals that we may not have had a chance to look at before because we simply didn't have people out there collecting the samples.

Our sample examinations this year, as we cranked out the numbers, went from about 10 or 12,000 last year to I think it was 34,000 sample exams at the border this year. So, obviously, what that is helping us to do is to better target products as well as things are progressing along. And we have a system for doing that through importer lists, et cetera. So it has given us a lot more information.
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