NR ASFV
AU Wykoff,R.
TI Opening Remarks
QU Workshop on TSE Risks in Relation to Source Material, Processing, and End-Product Use. June 8-9, 1998, College Park, MD
IA http://www.life.umd.edu/jifsan/tse/program.htm
PT Workshop
VT
RANDY WYKOFF:
Good morning. It is my pleasure to welcome you on behalf of the Acting Commissioner, Michael Friedman, as well as all of my colleagues and co-workers at the FDA.
This is an extremely important meeting for the Food and Drug Administration and it's important for two reasons. First of all, it's important because of the venue where it is taking place. As you have heard, this is the first meeting to be sponsored by JIFSAN. JIFSAN brings together the unique resources and capabilities of academia and government. And it presents both the academic world and the government world with opportunities that would be otherwise inaccessible. The second reason this meeting is important to the FDA is because of the topic that's being discussed. Transmissible Spongiform Encephalopathies (TSEs) pose tremendous regulatory challenges to the FDA.
The public expects and demands to be protected from preventable risks in consumer products. To meet our part of that challenge, FDA has taken a number of actions related to TSEs. As you have heard, we have put together an internal working group. We have convened an outside advisory committee of outside experts to provide us advice on what steps we can take to protect the public health. We have communicated regularly with regulated industry to outline steps that they can take to help reduce the risks of TSEs in certain products. We have developed and disseminated specific guidance in such areas as the use of animal protein and animal feed in sourcing and so on.
But for all of the actions that we have taken, certain realities remain. And among these realities is the fact that we have been forced to take very important public health actions in the absence of complete scientific information. We have been asked to make very important decisions to protect the public from TSEs while at the same time recognizing that we lack the complete information that we need. We have been asked to make these decisions without knowing for example precisely how TSEs are transmitted, how they are activated, whether they are species specific, what the natural history of disease is and so on.
The bottom line is that we at the regulatory agencies have been asked to make very important public health decisions with incomplete information. What this means is that we have an absolute obligation to continually review what is known and what is being learned about TSEs, to reevaluate the steps that we've taken in the past, and to ask what additional steps, if any, need to be taken in the future. To those ends, this workshop is exceptionally important. If this workshop meet its objectives, it would be invaluable not only to the FDA, but to our sister agencies both in the United States and internationally. I think there are two things that everyone in this room will agree with. The first, I think everyone will agree that it is time for a workshop like this. And secondly, I think everyone will agree that it's time for me to stop talking and to turn the podium over to the scientific portion of the agenda. Let me close by thanking those people who spent so many hours putting this workshop together, and everyone who volunteered to speak, and, again, welcome all of you here. Thank you.
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SP englisch