Food Safety Counterterrorism Initiatives

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A second point that is getting a lot of attention now, as it should, is the whole area of lab capacity and what we're calling surge capacity. Again, going back to the anthrax episode, it boggles my mind that during those several weeks across the country there were over 100,000 samples taken and tested and screened for anthrax. You think back to that time, everybody saw white powder. Everybody collected it, called the hazmat team, sent it in. But the labs couldn't handle it, and, of course, the labs also, as we found out later, didn't have the right test for it. And that was a big problem.

And so the CDC has worked hard through their laboratory response network, through clinical laboratories, to learn from that experience and build on it. And we're also realizing that those labs are not really equipped to deal with foods, to deal with testing of the food matrix. They don't have the methods, don't have the experience, don't necessarily have the know-how, and that is presenting a major, major challenge for us.

Finally, informing the public. As I've referenced a couple of times, these are the kind of events that will get attention like we have never seen before, and the importance of good communication, of constant communication, of knowing who your spokespeople are, I can tell you what we learned internally from just dealing with our own employees. And if you go back to your risk communication manuals it's all there. It just doesn't sing out to you until you've really experienced it as such. You know, especially a scientific agency like ours, we want to have the facts. We want to know the answer. We want to be up there standing--we know Listeria in this product, and these people shouldn't eat it, and we're recalling it, and the thing is taken care of. That's what we like to say. But the problem here is we're not going to know. For a long time we're not going to know. And at that time, it's not about conveying information. It's about building trust. It's about building trust with the public, that you'll be open with them, that you'll be honest with them, that you'll tell them where there is a problem, because basically they think we will not.

You know, think back to alar in apples. All the government people said they're safe, apples are safe, apples are safe. Meryl Streep stood up, took an apple out of the refrigerator, threw it in the basket, and everybody in the country did the same thing. And so the importance of the right kind of public communications is critical.

Finally, most importantly, but also most long term, is the whole issue of prevention and deterrence. Imports is an area that all government agencies involved with that are critically worried about. Interestingly, it's highlighted in the report I just referenced this morning, across the board, not focused on foods at all. And a major part of the resources FDA provided are geared to strengthening our role at the borders, and that's needed. There's also increased emphasis on laboratory testing, but really an important area that is only starting to receive--I can't say enough attention; it's starting to receive some attention--is the whole need for broad research agenda. And Dr. Meyerhoff covered a number of the points, but as a lot of things, we don't know basic stuff. We don't really know what the--in anthrax, for example, what GI anthrax really is, you know, what its likelihood is, what its severity is. We know more about inhalation, more about cutaneous. We kind of jump through quickly to GI anthrax, but when, in fact, in a survey of the literature, not as much is known as people thought.

We need to know more about how these agents act, what diseases they cause, how to detect them, what medical countermeasures are needed to respond to them. This is a whole enormous area. In our kind of smaller world of FDA and laboratories is the area of methods development. There is a massive task to be done, and, unfortunately, in the world of research, it's boring stuff. You know, methods development is not where the Nobel Prize is won, but we need to be able to devote enough of the research dollars and interest so we can do our job, so that if there is an event we don't have presumptive positive on Monday that the milk supply is unsafe, only to find out six days later that it was all a mistake and all for nothing, didn't have a good test. That is not going to wash, I can assure you.

The areas of special attention. Number one, we have been fortunate. During this time it was quickly recognized that large parts of FDA, but especially the food section, the chronic under funding that has been circulating in Congress, really came to the fore. People understood why we should be worried, and as Dr. Meyerhoff pointed out in her slides, roughly two-thirds of the supplemental appropriation went to the food area. Almost all of that, appropriately again, went to the field, and most of that has gone to the border. We now have more people at more borders. We doubled the exams at the border this year. We're doubling again this year. The Office of Regulatory Affairs is truly to be congratulated for being able to hire over 600 people in just a few months, get them trained, up and running, working productively. It's really something of historic nature in the FDA.

In the food area and in the field, not since the early 1970s and bon vivant have we seen this kind of hiring and new blood brought into the FDA. Obviously, not only will it help us for this immediate issue, but the leaders 20 years from now will be from the class that was hired this past year. And they are a good class and we are very proud of them.

Second, legislative authorities. We received the benefit of new legislation, and I'll go over a little more of that in a minute. We also devised a guidance for the industry, what steps they can be taking in their own establishments to reduce the risk. And finally, strengthening communication and coordination of other federal agencies. That's always an issue. Even an article like this that doesn't mention our Department or the FDA, does manage to say there is not a single food agency. And so we're used to seeing that and reading that everywhere, but I do want to assure you, we do talk regularly, we meet regularly. There was a lot of coordination among the federal agencies, but like so many issues, it does take work and it does need constant nurturing.

Let me focus a little on the new legislation. The areas, while there are five major title areas of the legislation, only one of which deals with food, and in the food area there are over a dozen provisions. The four areas that are getting the most attention because they need new regulations from the FDA have to do with these four areas. Number one, registration of food facilities. Many people are surprised. "You mean that didn't always occur?" In a drug area you have to register with the government. In many other areas you have to register. Not in the food area, so that's new. And that covers all the products we regulate, food, animal feed, dietary supplements, the whole shebang, and also includes for establishments. The challenge is for a place that didn't have any registration, now we're looking at registration of upward to 300,000 facilities. And so that itself is a major challenge, not just the right regulations, but to have the IT systems in place so we can pull that off.

Second is the establishment and maintenance of records. This has always been a major bone of contention with the food industry. Again, in the drug industry it's relatively accepted because it's been part of the law for so many years. In the food industry they're my records. They're my records, they're not yours. And you know, basically when you get a criminal search warrant, you're going to get it and see records.

But recognition, the time for that has come and gone. If we are to have rapid containment of an outbreak, we need to quickly be able to trace back where the food came from, and if it's a problem at a facility we need to be able to trace forward where it went to. And so there is new legislation to require a step-wise maintenance of records, of what they--it's basically described as one up, one down. You need to keep a record where you bought it from, where you sold it to. And then the next person along the chain has to do the same thing, so that there ought to be a chain back and forth. It will not be foolproof. There are lots of areas that are not so susceptible, where products are commingled. You may know where you see it, but at the end you're not going to know which one started from where, and ingredients are commingled at manufacturing sites. So it is not a foolproof system, but it is a system that will be significantly improved over what we have now.

Third, imports. Again, major interest in imports, a system for prior notice of imported food and shipments. We're getting now, what, John, 5 million, 6 million entries a year. That's a lot of food coming across the border. And the notion is if we had prior notice we could better triage and decide what we really need to look at, and finally be able to detain goods, an administrative detention mechanism, so that if there is a problem--and this is largely domestic, because we do have that authority at the border, that we could, instead of running to the state officials, which we do now, and say, "Can you put a hold on this while we go to court," We would be able to do that ourselves. We have that authority in the medical device area, so FDA has some experience with how to do that. All of these regulations are on a--for lack of a better phrase, a really fast track. The reason is not just because the law tells us to do them, for better or for worse, there's a long history of statutory deadlines. Some get met, some don't. But the ones that get met, I can assure you, are the ones that have a hammer, meaning if you don't meet it, something even worse happens. And under registration, if we don't have regs out on how to register, they still have to register or the food can't be sold or imported, and that's a pretty heavy hammer. So we will have a registration system in place I can assure you.

Same with prior notice. There will be a prior notice system. Both of those December 12th, 2003. That's only a little more than a year away from now. There will be one in place because they are required by law, where they may not import their goods. So I sure hope, since they can't import them, and we don't want to have a line at the Mexican border all the way down to Argentina, which is where it would be in about 5 hours I think. We are going to have to be sure we have that in place. So a lot of effort is going on into that.

Guidance to the industry. I reference this quickly. This is one of the things we're able to do early on, and have gotten a lot of positive feedback on. We have guidance both for domestic producers as well as for importers. They are designed to be preventive measures. One of the areas we got a lot of feedback on was retail area is really different in many ways from a manufacturing establishment, the most obvious of which is, when you think of intentional contamination, the most important thing is access, who can get in. Well, in a food manufacturing plant, you want to keep out people you don't know. But think about your local food store. You want people you don't know coming in. How else are you going to sell your products? And so there are some significant differences, and so as we go through the next round of guidance, we'll be doing something specific with year two, the retail community, and we've had a lot of meetings with them on that.

I want to pause here, and let my energy level go down a little bit. When we first started, I guess the first presentation of this type I gave last December, and that was--I mean last fall was such crunch time, I can't even describe it because I don't think my mind would be clear enough to be able to try and describe it. It was just constant overload. And you know, the period it looked like, when you start seeing how much there is to do, the food system is so wide open, it is not geared to protection of this type, that it almost feels, I mean, it almost felt overwhelming, and you wonder, should I just give up? Should I just say we can't do this. Go and create and Department of Homeland Security, staff them up, let them do the right thing.

And so we kind of paused and took an inventory, if you will, what are our assets or what do we have going for us? And we realized we actually have a fair amount. Number one, we have a lot of capability and know-how, as I mentioned earlier. Not only do we have a lot of good microbiologists and toxicologists and chemists, but we have people that have varying backgrounds. You find the people that have been to the military, people that have gone parts of their career through CDC, infectious disease areas, and when you take that, you add what's known in academic institutions, you add what's known in the industry. There's a lot of capability and know-how in this country. And realizing that, I think was positive point number one.

Positive point number two is that we do have nurtured and believe we have a positive relationship with the industry we deal with. To be honest, I was a little worried that the legislation would become so acrimonious that might pull away. We're able to keep that under control. But by and large, this is an area you have to be able to work with the industry on. This is something we have a joint problem, a joint enemy, and indeed they had joint resolutions, and we feel good about that.

Third, the FDA has a long history of successfully responding to challenges. Part of our culture, part of who we are, part of why we work here, part of our heritage, if you will, is we do rise to the occasion. There's lots of examples of that dating back to 1906, most recently successes on food safety that I ascribed earlier.

And finally, there is a lot of public trust in the FDA. I talked before about credibility and public communication. The public does believe the FDA and we'll need that, and the FDA does have a very strong esprit d'corps and ability to rise to challenges. So this is a little bit of true confessions, but once we kind of catalogued these, we said, "Well, wait a minute. We can do this. We can do this too."

In conclusion then how do we kind of reflect on this? I think number one, food safety and food security, while there are differences certainly, they are closely related. As I said, the same kinds of systems and approaches that have worked well in food safety are going to help us here too. Number two, FDA is certainly increasing its vigilance. I think that by now that's an understatement. Three, this is under-anticipation. We need to be prepared for what is reasonably foreseeable, and we spend a lot of time trying to understand what might be reasonably foreseeable. But, four, we can't figure everything out in advance. We have to recognize that unexpected things happen, and the way I think of it is, you know, you have your forward sight for what you're looking at, but you also have peripheral vision. And when something happens out of peripheral vision, you need to turn to it, and now that's in your central sight. We need to realize unexpected stuff is going to happen, and that's when you rely back to what are your assets, what are your tools, what are your underlying capabilities. And then finally that means is we need to have the flexibility to respond swiftly and effectively to anything that does occur. God forbid that it does.

With that I am happy to, I guess, welcome Dr. Meyerhoff back up here with me to help answer questions across the spectrum of our issues. Thank you very much.

DR. LANGER: Thank you. Why don't we open it up for questions, comments?

MR. DOYLE: Thank you very much. I really appreciate the comments. I thought that whole presentation was very well done.

Mr. Levitt, for you, I continually hear and agree that imports are probably one of the our real soft spots. Is the Agency taking a holistic size-based approach to inspection of imports? Are we profiling, based on science, the greatest foods of risk? Are we determining, based n science, the best sampling methods, as well as the best testing methods and taking advantage of science to do all this?
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