NR ASML
AU Hueston,W.D.
TI Evaluating TSE Risks: Sourcing, Processing and End-Product Use
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 (existiert nicht mehr)
PT Workshop
VT
WILLIAM D. HUESTON:
As well as having worked in Government, I've worked in academia, I've worked in industry and I've also worked in private practice. And that gives me, if nothing else, a unique perspective to bring to consideration of theTransmissible Spongiform Encephalopathies (TSE's). Welcome to the challenge of protecting and improving animal and human health. TSE provides us a wonderful opportunity or a wonderful example of the challenge of a new and emerging diseases and the complexity of prevention strategies. This international forum evolved out of a shared need by government agencies, by academia, by a number of countries, and by industry groups to develop a rational basis and a shared basis for evaluating TSE risks. Now for my personal experience, I've had the opportunity to serve on Spongiform Encephalopathy Advisory Committees in the United Stated and in the United Kingdom to participate in scientific consultations for the International Organization of Animal Health as well as the World Health Organization to provide updates, advice and consultation to consumers, to cattle producers, to agribusiness, to pharmaceutical companies and to professional organizations. That gives me an opportunity to address a question that may be burning for some of you. Why is this meeting different? Why hold this meeting? In fact, some of the concepts that will be discussed in this meeting you can also find in consultations of the World Health Organization, or the OIE, or company reports, or statements by national governments. A major reason is that these consultations and the previous meetings that have been held all share some tremendous public perception challenges. Number one (1), the question of openness or closed. The majority of the advisory committees and consultations in which I've participated have been closed. Closed to the public, limited participation. If there's one thing I've learned is that public meetings may be uniquely North American. But in the wake of a closed meeting, there creates in minds of the public the idea that something happened in the secrecy of that meeting that the organizers of the meeting are afraid to tell. That there is some undercurrent, there is some hidden message about dangerous information because if it weren't so dangerous, then everyone would be able to hear it and talk about it. Secondly, we have achieved a wonderful standard in much of the world that says, seek first to identify the bias. Maintain that healthy skepticism that discounts meetings by identifying the host. So if the scientific consultation is held in the United Kingdom, we look skeptically because the United Kingdom has Bovine Spongiform Encephalopathy and after all, if they have the disease, how can we trust what they might say? If the meeting is held or sponsored by an industry organization, well heaven help us, because they have a native conflict of interest, because it is in their best interest to put forth that for their product, there is no risk. If the meeting is hosted by a professional organization, say a veterinary organization, then it is held up as having that limited perspective of an animal doctor and obviously does not have implications as it affects human products and human applications. So, we have tried using this University of Maryland initiative and the JIFSAN sponsorship to set up a meeting that is first and foremost, public, and, secondly, that pulls together a broad range of sponsorship from governments, from industry, from professional organizations. Finally, the meeting is open to anyone that would wish to come and hear and discuss and learn about the science underlying the evaluation of risks. So to reiterate the comment that was made by Dr. Mazzocchi, the University offers a natural ground for sharing ideas. An open forum where in fact academic freedom is often sighted as a justification that anyone can stand up and say anything they want in the name of academic freedom. Let me go back then to talk about the unique characteristics of this meeting that it is collectively sponsored by a group of organizations covering government, industry and academia. We are focusing on a very complex set or class of diseases. The Transmissible Spongiform Encephalopathy's (TSEs) affect a number of animal species and man. In most cases, these diseases appear to be unrelated. We have the added challenge that detection of the agent in the live animal or the live human is very difficult. Thirdly, that there is no treatment or protective vaccination that currently exists. And lastly, that the agent is very resistant to destruction. Further complicating these discussions of the evaluation of risks are the complexity of the use of human and animal materials in our day and age for medical purposes and for a wide variety of other uses. So, if we look at animal tissues and fluids, these find their way into food products, animal feed products, cosmetics, dietary supplements, pharmaceuticals, and medical devices as Randy Wykoff just stressed. And the complexity of the paths that they follow, they influence the daily lives of each of us in this room. But the complexity of these processes and these pathways is not understood by a great number of people. And that complexity can be overwhelming and lend itself to misunderstanding and apprehension. In light of these complexities, risk analysis has emerged as a valuable, albeit, misunderstood set of tools for supporting rational decision making in the face of uncertainty. Rather than get into the semantic argument about what is risk assessment versus hazard identification, I'd like to present to you a series of questions. Risk analysis is basically what can go wrong and how would it happen. Secondly, how likely are things to go wrong and what would be the implications? So, what can go wrong, and how likely is it to go wrong? What are the implications? Then we address our options to reduce the likelihood that things go wrong or to reduce or minimize the implications should they go wrong? And lastly and probably most importantly, how do we keep all of the potentially affected parties involved in this process? There's nothing magical about this whole field of risk analysis. Now for a fact, all of us do risk analysis on a daily basis. You've done risk analysis in coming to this meeting. You have evaluated in walking into this auditorium, all be it unlikely that it's conscious, you have set out or somewhere in your past experience have then laid out a series of what can go wrong. The roof could collapse, we could be hit by an asteroid, there could be a terrorist event, you could be caught in a compromising position, one can go on and on. And my guess is that everyone in this room could add to the discussion the things that could go wrong in this room. I am going to assume that each of you went for the risk assessment process and said the likelihood of things going wrong is sufficiently small, that I chose to come to this meeting rather than stay away. So the likelihood of the roof collapsing or their being a terrorist event or my being caught in a compromising position is sufficiently small that I chosen to come to this meeting. Now mind you, you've implemented some risk management strategies along the way. Many of you checked your bearings, perhaps you checked out the room before you came in. You have some prior evidence that of knowing about the building structure, knowing about how buildings are put together. I see several of you now, reexamining the ceiling. But suffice is to say, you have applied the concepts of risk analysis, and each of us do that on a daily basis. So the idea of this meeting and applying the tools of risk analysis is to begin and go through that process. To say what can go wrong and what would have happened. Knowing the pathways, knowing the opportunities for things to go wrong is the first step in assessing the likelihood that they'd go wrong. The greatest hazard or danger about which we're concerned, in this meeting, is the transmission of Transmissible Spongiform Encephalopathy's (TSEs) from animal to animal, from human to human, from animal to human or from human to animal. That's our goal. We will be discussing over the course of the day how might this transmission occur. And recognizing, and I want to remind you of the important caveat. That talking about possibilities, potentials and hypotheticals does not mean that those things actually occur at a high likelihood. But unless we systematically approach laying out those options, we cannot do a complete job of evaluating existing information toward our decisions. So we are promoting and encouraging the use of a systems engineering approach. A systems approach which looks at inputs, processes and outputs. Inputs in this case are the raw materials, processes are those procedures and practices that transform a raw material into an end product. And in the end product, we're looking at the uses for these end products, the ways in which they're used and the amount of exposure. Again recommendations relating to sourcing, processing and end use have emerged from a number of different advisory groups and committees and meetings around the world in a variety of settings. This to the best of my knowledge is the first meeting that has focused exclusively on sourcing, processing and use as a systematic approach to set the foundation for the TSE risk evaluation. We are attempting to pool knowledge of physicians, of veterinarians, of animal scientists, of engineers and microbiologists and a number of other disciplines in order that we might address in some systematic way the evaluation of risks. For the benefit of you as a representative of your organization or your country and also as an individual. The goal of this meeting is not to generate a risk assessment. It is not at the end of the day to say this is the only way that one can evaluate risks and this is a formula that you can take home crank through your data and come up with a yes/no answer as to whether or not a sufficient risk exists to take additional action. But rather to set the stage for a common language has a basis of a evaluation of TSE risks. We're looking at identifying shared interests, looking at interests rather than positions and using robust tools for evaluating TSE risks, as we struggle to make rational decisions in the face of uncertainty to protect and promote animal and human health. With that, I welcome you to refill your refreshments, we'll have about a ten (10) minute break. The refreshments are out in the hallway, as I said there are restrooms if you turn right going out of the auditorium. And we will convene promptly at 10:00 to begin our first session on raw material sourcing.
DR. WILLIAM D. HUESTON:
Move towards your seats, please. In the interest of keeping on-time. Our first session on raw material sourcing will begin momentarily. As a preamble, I would like to welcome Dr. Stuart MacDiarmid, who is now the National Manager for Agriculture Security with the Ministry of Agriculture and Forestry's regulatory authority in New Zealand. And you have a brief biosketch about each of the speakers, in fact in your program, and Stuart's is on page fifteen (15). I would provide my personal introduction to say that Stu MacDiarmid has been involved in both the fields of risk analysis and in attempting to evaluate risks of TSE's for now approximately six (6) years, seven (7) years. Yes, from the late 1980's, so close to ten (10) years. And I am absolutely thrilled that he's been able to join us today to set the stage as we talk about raw material sourcing. Stuart, I'll turn it to you.
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SP englisch