TOPICS > Health

Extended Interview: FDA Food Protection Head Discusses Food Safety

June 8, 2007 at 11:45 AM EDT


BETTY ANN BOWSER: Let’s start with what the [melamine] alert is that’s out there, and what does it mean? What are the implications in terms of protecting Americans with food safety?

DAVID ACHESON: The melamine situation evolved initially with sick pets, with the identification of melamine and melamine-type compounds in wheat gluten that had gone into pet food.

Several weeks after that started, we then learned of a similar problem with melamine and melamine-type compounds in rice protein concentrate, completely unrelated to the wheat gluten. What that did for us was to make us realize that this problem looked like it could be broader than just a single product.

The first instance was just one product, it was one company, and it looked like it could be isolated. When you start to see it in an unrelated compound…clearly that raises other questions. So what we did as soon as we determined that, we decided that the best thing to do, because all these products had come from China, was to put what we call an import alert out.

Now, what that means is that no vegetable-based protein concentrate — so this is a protein concentrate like wheat or rice or soy — that comes from China can enter the US market until we have proof that it is safe. It gets stopped at the border, and it has to go through a series of testing — not by FDA, but by the company. What that does is it puts the onus on the company to prove to us that it’s safe, and they have to use a validated test, it has to be reviewed, and it goes through a fairly rigorous process on our part.

BETTY ANN BOWSER: So it’s not FDA government employees that are doing the testing, it’s the companies themselves.

DAVID ACHESON: Not for the import alert, that’s correct.

BETTY ANN BOWSER: How do you know you’re getting all of it?

DAVID ACHESON: What we do is use the records — I mean, obviously, if somebody decides that they’re going to import something into this country labeled as one thing but it is actually something completely different, they could get it in here by doing that, because we’re basing it on how it’s labeled.

There is also, above and beyond how it’s labeled, all imports have to go through what we call our prior notice center. The prior notice center is a system that was set up after 9/11. It was initially focused on bioterrorism issues. Nobody can import a food product into the United States without it coming through the prior notice center. What that means is they have to submit paperwork ahead of time. That gets reviewed for the type of food, the country of origin, and any information that we may have related to the importers or the manufacturers, or anything about it. It gets run through a series of classified and high security systems, so that if something flags as a problem, it can be pulled out, inspected, and tested.

So we do have that as a backdrop for people who may be trying to bring things in that are mislabeled, so if they’ve done it before and been found, then we’re keyed into it. But the vast majority of importers, I mean, they’re not going to be bringing stuff in labeled as one thing because ultimately they want to sell it to a U.S. manufacturer who is bona fide, and they’re going to say “well, you know, why is this wheat gluten that you’re shipping to me labeled as chicken feed” — to pick a crazy example.

So we have a fairly high degree of confidence that virtually all of it is getting stopped.

BETTY ANN BOWSER: And you have confidence in the company’s ability to produce results that prove to you that they’re safe?

DAVID ACHESON: They have to. They have to. And if they don’t, if we’re not completely satisfied, it’s going nowhere. And that’s FDA taking that role.

What that does for us is it basically shifts the burden because our responsibility is to make sure that the product is safe. And if we can shift the burden of the testing away from our systems, it simply — it’s not using our resources to do all the testing. But we’re using our resources to focus on the result of that test and say is it okay, was the method that they used, was it validated? It’s got to be done by a certified lab.

There are┬ámany things in place that are going to prevent just somebody coming up with a piece of paper and saying, “Well, here you go, FDA. It’s cleared, right?” No, not right. We go through a lot of steps to make sure that the result on that piece of paper is real and it’s come from a certified lab.

BETTY ANN BOWSER: I’ve heard some people, some critics, say that the FDA ought to be doing that testing, not the companies.

DAVID ACHESON: It’s certainly an argument. We have to — FDA has got to focus its resources where we can get most benefit. I mean, clearly, if we had unlimited resources and unlimited lab capacity, you might say that’s a reasonable suggestion. It chews up an enormous amount of resources. And at the end of the day, FDA cannot test every item of food that ever comes in the United States. It’s not practical to do that. We have to focus on where the risk is, and manufacturers have to take responsibility for the production of the safe product.

It’s our goal to make sure that they’re doing that, but we can’t have an FDA inspector looking over every manufacturing facility throughout the world.

In order to import into the United States, you have to be registered. That’s a part of the bioterrorism act. You have to be registered with us, with the United States to do that.

We have approximately 150,000 foreign manufactures registered right now, and there is no way ever we could get an FDA inspector in every one of those manufacturing facilities on a regular basis. The resources required would be enormous. So you’ve got to come up with systems that will ensure that they are doing the right thing, and I think looking to the future, that’s an area that we need to pay a lot more attention to.

Food safety and globalization

BETTY ANN BOWSER: How would you describe FDA's resources to deal with this kind of problem, given the fact that the rules have really changed in the last 10 years in terms of the globalization of food products, all the different additives and so forth, some of which used to be made here that are now coming in from other parts of the world. Are your resources adequate to meet this changing market?

DAVID ACHESON: You're correct, there have been enormous changes in the food system, and I think that what that has led to, it's led to some of the things that you've just mentioned -- globalization of the food supply, the whole concept of just-in-time in the food industry. Let's take spinach as an example that we were dealing with in the fall.

BETTY ANN BOWSER: What do you mean, just-in-time?

DAVID ACHESON: I'll explain. That spinach that's grown in a field on Monday is in the processing facility by Wednesday. You know, it's packaged, it's on trucks, it's out the door, and a week later it's in supermarkets. Now, obviously, it's a fresh product. It needs to move through quickly. But the days where there used to be massive warehouses stocked full of all kinds of food for months at a time ahead of time, they're not there nearly as much as they used to be. So manufacturers operate on a -- essentially because it costs money to hold things, they want a quick timeline between production, distribution, getting into retail, and to consumers.

So the whole system has gotten faster. That's what I mean by just-in-time. We're dealing with changes in consumer demand. We, all of us, expect everything on the grocery shelves, 24/7, 365 days a year. It doesn't matter what it is. It doesn't matter if you grow it in the US. You know, if you're used to eating some particular exotic fruit and you go to your local supermarket, you're not happy when it's not there. So it's got to come from some part of the world where you can produce it year-around.

So all of these changes have happened. What the FDA needs to do is to look at all these changes and come up with a strategy as to how to make shifts in the way we do things to address those changes, and in order to make those shifts, we're going to need more resources to do it.

There's no doubt in my mind that we cannot meet that challenge with the current level of resources. What we can do with the current level of resources is, I believe, respond effectively to the current emergencies, the current crises. We did it with spinach, we did it with peanut butter, we did it when we had issues with the tacos, and we're doing it with melamine.

Is it as rapid as I would like? No. Is it still efficient? Yes. And I think we need to be looking to make our response system even more robust.

BETTY ANN BOWSER: Do you think the FDA has been aggressive enough in seeking federal funding for these issues, given the fact that the market is changing?

DAVID ACHESON: Where FDA has been up to this point is really -- that's not for me to say because I've not been in this position more than 10 days. My goal is to get aggressive with this, and, you know, I have a passion to try to make this system work better. You know, I have a background as a physician and a research scientist in food-borne infections. I know what these things can do to people. It's nasty, and we need to take care of that.

So part of doing that is trying to obtain the resources, the expertise, the infrastructure, the changes that are necessary to get to that point. Clearly, if we had got all of that in the past, I probably wouldn't be in this position.

BETTY ANN BOWSER: Are you saying there's going to be a new day, that the buck is going to stop here from now on?

DAVID ACHESON: I wish I could say the bug was going to stop. I think we all have to acknowledge that we are never, ever going to get zero-risk food. You take a food like spinach or lettuce, something that's grown out in the dirt, in the open, it's going to have bacteria on it. The goal here is to reduce the likelihood to the lowest extent possible, based on all the technology and science that we have to do that.

I don't think in our lifetime we will ever get to zero risk, but the goal is to keep pushing that back, and not be complacent when we say well, it hasn't got any worse. We must be doing okay. We need to try to make it better.

So not bug-free, but philosophically I think what we need to do is get out of reaction and into prevention.

BETTY ANN BOWSER: Actually, I was using the old expression, "the buck stops here."

DAVID ACHESON: I thought you said the bug.

BETTY ANN BOWSER: I beg your pardon. So you may want to re-answer[...]So are you saying now that you've taken over this position, there's going to be a new day? I mean, one of the criticisms you hear a lot is that well, the culture is so firmly engrained at the FDA, they're not aggressive enough about seeking funding. Are things going to be different under your watch?

DAVID ACHESON: I think the commissioner, Dr. [Andrew] von Eschenbach, has created this position and invited me to be the first assistant commissioner for food protection, to take on that role. He's very clearly given me the charge to figure out what needs to get done, and to set about achieving it. And he's certainly been fully supportive of where we're trying to go with this, and is doing everything within his capacity to further this.

Using science to assess risk

BETTY ANN BOWSER: What is your biggest challenge?

DAVID ACHESON: Orchestrating all the multiple components that comprise the food system.

BETTY ANN BOWSER: What do you mean?

DAVID ACHESON: It's imports, it's domestic, it's farms, it's producers, it's manufacturers, it's distributors, it's transport, it's retail, it's hundreds of countries. It's many state, local, and federal partners, and I'm not taking on the role of leading food safety for the nation. I'm taking on the role of doing that for the Food and Drug Administration.

Having said that, we do regulate 80 percent of the food supply, everything except meat, poultry and egg products. So those I don't worry about. They're under the jurisdiction of the Department of Agriculture. Everything else is ours.

BETTY ANN BOWSER: That's still a lot of stuff.

DAVID ACHESON: It is a lot of stuff.

BETTY ANN BOWSER: And is it true that you only are able to inspect one percent of everything that comes into the country?

DAVID ACHESON: Currently we're inspecting about one percent of imports, but I would like to just add the caveat to that. We will never have the resources to inspect 100 percent. So where do you draw the line? Two percent? Five percent? 50 percent? 75 percent? I don't know. You don't know.

So the only logical approach is to say we need to draw a line based on risk. We need to do the inspections where we see the risks, and those risks need to be determined by looking at what are we getting in, where are we getting it from, is it coming from a part of the world, or a manufacturer, or a time of the year where we have concerns?

Again, another little example, one of the things that we've noticed in the past is if you import fresh produce from a country that's just had heavy rainstorms, it seems to increase the burden of salmonella on the produce.

Now, that's a little clue that you could use to say well, when these cantaloupes are coming in, and if the tracking systems are such that you know they were harvested two days after a heavy rainstorm, those cantaloupes should be targeted as opposed to in a dry season.

It's a silly little example, but what it does is it -- I mean, I'm talking about sophisticated targeting here based on risk. It's the only way that this is ultimately going to work because you're never going to have the resources to inspect it all.

BETTY ANN BOWSER: But if you're only inspecting 1 percent, how do you know that you're even in the ballpark at understanding what the risks are?

DAVID ACHESON: The inspections don't determine the risks. What determines the risk is doing a scientific risk analysis: which products are riskier, which places are they coming from are riskier, which times of year are riskier? I mean, supposing you were stuck with one percent? You want to use that one percent in as smart a way as you possibly can. I mean, worst case is that you stop one box out of every 100, or one container ship coming out of Iran, irrespective of what it is. I mean, that's not a risk-based approach at all. That's just sort of saying okay, the first 99 go, you stay, we're going to test you. The next 99 go, you stay, we're testing you. That's crazy.

What you want to do is you want to let through all the stuff that you think is lower risk and focus on the products that you think are higher risk.

BETTY ANN BOWSER: And how do you determine that?

DAVID ACHESON: Through scientific expertise. That's why you've got to have the scientific infrastructure.

BETTY ANN BOWSER: What does that mean?

DAVID ACHESON: What it means is that you need to understand how do bacteria, chemicals get into foods at the fundamental level, because in most instances that we deal with here, these foods get contaminated fairly early on. I mean, that's not an absolute. Certainly you can have problems right at retail in restaurants. Things can get contaminated.

But let's take spinach as another example. That most likely got contaminated on the farm, so that was very early in the chain. So you would say that products like that have a high likelihood of being contaminated. You get a sense as to what they're likely to be contaminated with. So products grown out in a field are likely to be contaminated with bacteria, not chemicals, some level of pesticides potentially, but we do have controls in place, and we do do random testing for pesticides.

So that's beginning to focus you down a little bit. And again, as you get more information, you could say well, you know, we know that at certain times of year we're almost never going to see salmonella on this stuff, but at other times of year, we're much more likely to. So again, that focuses you a little further.

It's all about understanding what technically you'd call microbial ecology. It's like where do bugs live, how do they move around from the environment into a food, when's a chemical likely to get into a food? Now, then you're dealing with the unknowns. You're dealing with the situations where the human element comes in.

BETTY ANN BOWSER: And that's more the case with the latest scare, is it not?

DAVID ACHESON: Yes, it's obviously not a microbial.

BETTY ANN BOWSER: I mean, it's not -- spinach is pretty obvious. People get sick, it gets reported, you go look, where did the spinach come from. This particular problem that we've had lately is much more of a detective mystery kind of a problem, is it not?

DAVID ACHESON: Well, they all are actually.

BETTY ANN BOWSER: Yes, you're right. But this is more of a different kind of a thing than just -

DAVID ACHESON: Yes, it is.

'We need to shift with the times'

BETTY ANN BOWSER: The spinach, it was domestically grown, or came from Mexico, close to home. This is China we're talking about. And then when the people got there to inspect, the plants were closed down. Does that give you pause as to what's going on and whether companies should be doing business with these companies in China?

DAVID ACHESON: Sure it gives me pause. One of the things, the activities that we've got going on right now is part of the melamine situation, because we are going out right now with our state partners to domestic U.S. companies that use protein concentrates, particularly if they use them from China, and we're doing two things. Number one, we're raising awareness with these people about the importance of knowing all there is to know about their supplier.

Don't just assume that just because it's five bucks a bag cheaper you should go with it. I'm just picking an example there. But why do you use that supplier? Do you know him? Do the company that it's coming from?

BETTY ANN BOWSER: And what do they say most of the time? Do they know anything about them?

DAVID ACHESON: I don't think they know as much about them as I would like them to know about them. And I think that that's something that needs to change. It needs to change in the context of both food safety as well as food defense.

BETTY ANN BOWSER: Who's going to make them change?

DAVID ACHESON: Most of them that I've spoken with, once you sort of say well, wouldn't this be a good thing to do, they'll say, "You know, you're right. We'll do that." And I have been in contact with a company just in the last couple of weeks over melamine, and talking to the president of that company and pointing this out. And he said, "Well, you're absolutely right. We've changed our practices. Based on this we're doing things differently."

So, you know, responsible companies, first of all, they don't want to make people sick, or animals sick. I mean, that's fundamental that I've learned in this job working with industry, and whatever people may say, they don't want to make people sick for all kinds of reasons -- because it damages the name, it damages the product, you get cost of the recalls. That's not what they're about. But sometimes they need a little help in terms of well, what can we do to maximize prevention strategies? And you and I talking about it today may think well, that's obvious. Know about your supplier.

But it's not necessarily obvious to everybody, so there's a big education process going on there to get people to ask that question.

BETTY ANN BOWSER: Is it possible that the FDA really does need to be given a stronger mandate, more resources, more money, given that the world has changed in terms of how food comes to the table?

DAVID ACHESON: We need to shift with the times. More resources is definitely part of it, and part of the exercise that I'm starting to go through right now in this new position is to look at what current authorities do we need to tweak a little bit? Things that we already have authority to do, but maybe we need to do it just slightly differently.

And then secondly, what new authorities do we need to get the job done properly?

BETTY ANN BOWSER: What would you say to the public about how safe our food supply is, particularly things that we eat that are made involving products that are imported from Asia?

DAVID ACHESON: I think consumers have a lot of concern right now about the safety of the food that they're eating. But we all need to put this in the context of how much food we eat and how rarely we get sick from it. Most of us eat at least three meals a day. Rarely in that context do we get sick when you consider the pounds and pounds and pounds of food that we consume on an annual basis.

But people do get sick, and that's not acceptable. We want to try to minimize illness, reduce the likelihood of people getting sick.

At the end of the day, I feel confident that the food supply in the United States is still one of the safest in the world, despite the recent outbreaks. We haven't seen a huge jump in the number of illnesses based on data from CDC. Yes, it varies a little bit, but we haven't sort of seen any major increase in overall food-borne illness in the last decade.

But the goal is to continually strive for improvement, is to make it better and better and better, and the challenges get larger because of the globalization, and the consumer perceptions, and the consumer demands. But consumers shouldn't feel that it's dangerous to eat food. There's vast quantities of food consumed that are perfectly safe, including fresh produce.

How much will it cost?

BETTY ANN BOWSER: When Tommy Thompson stepped down from his job, one of the last things he said was he expressed - and I'm not quoting him, I just remember - I'm paraphrasing him. He expressed really grave concern about the food in this country in terms of bioterrorism. How easy would it be for bad guys to do something like that?

DAVID ACHESON: We've put an awful lot in place in terms of deliberate attacks on the food supply since 9/11. We don't talk a lot about it because one of the things that you don't want with regard to that sort of thing is to tell the world exactly what you're doing, because what they'll do is they'll say well, we'll go in an area where they're not - they're not doing something. They'll look for the holes.

But we have devoted significant resources and significant systems towards preventative strategies, raising awareness. We've done a lot of work with industry, particularly the manufacturing and processing industry in the United States, to raise awareness, work with them on understanding where their vulnerabilities are, work with them on potential protective strategies, build a response system that is better than it used to be.

We have the prior notice center that is in place since 9/11. That requires all foreign importers to be registered with us and to submit notice prior to importing something into the United States. That didn't exist before 9/11 in the form that it's in now.

So a lot has been done. Is the system still vulnerable to somebody doing something? I'd have to say yes, of course it is. We couldn't make it 100 percent tight. And an example of that is, for example, at retail. You have to have a retail environment where people can come and go freely to buy the products that they want. If somebody decided to do something at retail that was bad, and we do see that from time to time with tampering - little low-level problems, it's going to be very difficult to prevent.

Raising awareness is important, and it's not just with industry, but with consumers also. Consumers have a role to play in all of this, especially from the food safety side, keeping the food safe once it comes under their control in terms of cooking it properly, making sure it's refrigerated, avoiding cross-contamination where you've got your poultry and your salad on the same cutting board, making sure things are cleaned up properly.

So consumers can do a lot as well, and also being just aware of, you know, food is a potential target, and if you see something that you think isn't right, you know, bring it to somebody's attention.

BETTY ANN BOWSER: If you could wave a magic wand and you could have three wishes tomorrow, what would they be?

DAVID ACHESON: Oh, boy. More time to solve the problem. I think there is this public perception of urgency, and I share that. But life has taught me that if you make decisions a little too fast, you can make the wrong decision. And clearly, we need to make decisions, we need to make them quickly, but we need to remain nimble enough and open enough that if that initial decision isn't quite right, we can tweak it a little bit.

So having the luxury of a little more time to be more deliberative would be nice. It's not realistic.

I think the other desires would be simply to be able to expediate the development of the systems once you've decided what it is that you want is going to work. It just takes a while to rebuild the infrastructure and the technology that I believe we need.

You know, we've lost scientists over the years. You can't simply say okay, here's five million dollars, go out and hire yourself a whole cadre of excellent scientists, and I want them in by next Monday. It doesn't work that way.

So again, if I was waving my magic wand, it would be, again, once the decisions are made, let's get them operating as fast as we possibly can.

But the agency is very committed to food safety. I mean, there's no question about that. It's made up of very dedicated, hard-working individuals. So the will is there.

BETTY ANN BOWSER: And the money?

DAVID ACHESON: Money will be, I hope, forthcoming.





BETTY ANN BOWSER: But, I mean, you must have thought about it in terms of what kind of a financial commitment - I mean, the world's changing. The needs of the American public are changing, and what FDA has to do about it is going to change. It has to change.

DAVID ACHESON: Yes. It has to change.

BETTY ANN BOWSER: So how would you characterize what needs to be done in a general sort of way, in terms of financial commitment?

DAVID ACHESON: There needs to be an initial financial commitment, in my opinion, to get the ball rolling, to do what we can do right now with the tweaks and the fixes and the changes that we can make right now, given that we can't make an instant fix to the problem.

Then I believe there needs to be a longer term commitment to building on what we can do in 2007 to 2008. Moving forward, building off what we have done, to get to where we need to go and then to stay ahead of the curve and not be playing catch-up. I feel right now that we're playing catch-up, and I want to get to the point where we've caught up and we're moving ahead, and we're being proactive, and we're finding stuff that we haven't yet thought about.

But that's for the future. That's - you know, in terms of what is it going to cost, it's not going to be cheap. This is not an inexpensive operation to get it right with what I'm talking about, or the types of infrastructure and the types of changes. But in terms of numbers, I don't know, I'm just not there yet.

BETTY ANN BOWSER: If consumers do have questions - I mean, not everybody gets to sit down like I have and talk to you, right from the horse's mouth. Where can consumers go for information?

DAVID ACHESON: We have a lot of information on our web site about food safety. That's on If you go onto and check out the foods over on the left-hand side of that page, it will take you to the Center for Food Safety and Applied Nutrition.

There's a lot of information on that and on other federal web sites that will help consumers understand what they can do in terms of how to cook something properly, how to chill something properly, how to avoid cross-contamination, what's the best way to keep things clean. And there are many things that consumers can do at home to help themselves, and a lot of that information is available at