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U.S. Department of Health and Human Services

Animal & Veterinary

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Introduction

Dr. Keith Sterner

DR. STERNER: Good morning. I am Keith Sterner. A couple of ground rules if we could. Yesterday, I noticed a number of cell phones going off. Those of you who have cell phones, if you would switch them to vibrator mode or some other form of notification other than distracting from the proceedings, it will help for an orderly proceedings this morning.

I would like to welcome you to the FDA Center of Veterinary Medicine Workshop. I always look forward to Fridays because my favorite radio program is "Science Friday" on NPR. And I think yesterday and today have been and will be about science. Not perfect in everyone's eyes, but this workshop is everybody's opportunity to contribute to the dialogue.

I want to echo Dr. Sundlof's comments that it is of paramount importance to keep differences of opinion to an objective criterion and not to those of a personal nature. Yesterday, we listened to numerous eloquent presentations on the risk assessment. And there appeared to be general agreement from the presenters as well as the panel that the model was workable within the parameters of the given assumptions.

Today we have a very full agenda. And I intend to be relentless in keeping us on task. Given the intellectual prowess and the large volume of information our speakers wish to convey to us today, my task is somewhat akin to that of trying herd cats.

We all have to eat. As biological entities, it is not an option to opt-out. We do as individuals, however, have choices. Our deliberations here will have significant and far-reaching impact on many individuals and industries not only in the Untied States, but also in the rest of the world.

These workshops that the CVM is sponsoring will help to set policy that will hopefully emphasize and ensure a meaningful, positive public health impact while not creating too great a barrier to the animal, agriculture and pharmaceutical industries that will most directly be affected.

It should be apparent to almost everyone that it is entirely possible that the human health problems discussed yesterday could be far more easily impacted through food processing technology that would render foods of animal origin sterile, at least as far as the point of purchase and that removal of fluoroquinolones entirely or for that matter all antimicrobials would not ensure that human illness would not or could not occur.

That fact has long been recognized in one food of animal origin. That is milk. Indeed, pasteurization has helped to ensure that a nutritious food product that was safe for human consumption.

Food production and processing, however, are not the subject or the focus of this workshop. We are here to comment on the current state of knowledge as it would apply to the veterinary antimicrobial drug approval process.

If by some small miracle we complete our dialogue on the risk assessment model, we may even broach the subject of thresholds. That may prove to be at best an illusory promise. Speaking as the moderator of this session, I do intend, however, to try and attain that goal. I will remind the speakers to try very hard to stay on time so that we can stay on schedule.

With that, our first speaker this morning is Dr. Alan Rulis. He is with the FDA since 1977. He holds a B.A. in chemistry from Logastana College in Illinois and a Ph.D. in 1972 in chemistry from the University of Wisconsin. Prior to joining the FDA, he did post-doctoral research in chemistry in the Netherlands and Canada and taught chemistry at the University of Toronto in Canada. He will be under assessment of risk looking at food additives. Alan.