Extended Interview: FDA Food Protection Head Discusses Food Safety

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 many 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.