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Lester M. Crawford, Jr., D.V.M., Ph.D. - FDA Public Meeting

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

FDA Public Meeting on Acrylamide
in the U.S. Food Supply

Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,
September 30, 2002
Good morning. We have invited you to this meeting to share with you what we know, what we don't know, and what we need to find out about acrylamide as a potential public health hazard. You will also hear how we plan to conduct the necessary research, and how we want to utilize its results.

We're dealing with a matter of public health significance, because acrylamide may present a dietary risk that, we believe, could be prevented or reduced with the help of the new knowledge that our agency and its partners expect to develop. So the issue before us is not only an intriguing scientific challenge, but it is of primary interest to consumers.

That's why we want to outline for you -- and submit it for public comment -- our plan for characterizing and managing the potential health hazard that might be caused by consumption of food containing acrylamide. My colleagues will have a lot to say about acrylamide and our action plan, but in general, this is the issue before us:

Last spring, researchers at the Swedish National Food Administration and Stockholm University analyzed food samples, including several favorite American products, and found that they contained various levels of acrylamide. Their study suggested that acrylamide formation is particularly associated with carbohydrate-rich foods that are oven-baked or fried at high temperatures.

Since then, scientists in Norway, the United Kingdom and Switzerland have come up with similar findings. For example, a meeting of the Food and Agriculture and World Health Organizations in June reported that acrylamide levels in 39 samples of potato chips ranged from less than 1.4 micrograms to 100 micrograms per ounce, with a mean level of 15 micrograms.

Forty-one samples of soft bread contained acrylamide levels between less than 30 micrograms and 162 micrograms per kilogram, which is little more than two one-pound loaves, with a mean level of 50 micrograms. Our own preliminary analysis appears to be in basic agreement with these results.

These are disturbing findings, not so much because of what we know about the chemical -- which is relatively little -- but rather because of we don't know about it.

We know that acrylamide is an organic chemical that is most widely used as a coagulant in water treatment, but has many other industrial uses, including in the production of organic chemicals, dyes, and plastics. We also know -- and have known for some time -- that acrylamide causes or is associated with cancer in laboratory animals.

What we don't know is the answers to the many public health questions that these new findings raise, the most crucial of which is, of course, to what extent -- if any -- acrylamide in food presents a hazard to human health. Epidemiological studies conducted in the past did not show increased cancer risk in people exposed to certain amounts of acrylamide, but the studies were limited in scope, and did not include ingestion of the chemical in food.

We therefore need to investigate whether acrylamide in food is a potential human carcinogen, and whether it is genotoxic -- whether it can cause mutations of germ cells. We need to know in which foods acrylamide occurs; what is the level of exposure for the general population; what is the bioavailability of acrylamide in food; and what are the biomarkers of acrylamide exposure.

And we need to know more about acrylamide formation so that -- if the chemical does prove to pose a risk to humans -- we can suggest how to modify food processing techniques to prevent or reduce the formation of that chemical. This is a big task, and as you will hear in more detail from my colleagues, we're working on it. We're in the process of assessing our consumers' dietary exposure to acrylamide; we're gathering new information about its toxicology; and we are participating in the investigation of how and under what cooking processes acrylamide is formed in food.

We have already developed a method to determine the levels of the chemical in foods, and we are using it to test scores of different products. But as you will hear later in more detail, a great deal has to be done to find scientific answers to the questions about acrylamide that would enable us to accurately measure the risk that chemical may pose to the public health, and, if necessary, try to devise a way or ways of managing it.

Foods rich in carbohydrates are and have been for centuries a robust basis of human diet, and we must make sure that they enhance, and not imperil, human health. This is the ultimate purpose of our action plan. It's an essential goal for the protection of public health, and I take your presence here as a sign that we can count on your help in our efforts to reach it.

Again, thank you for coming. I hope that you will find our presentations both informative and stimulating.