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TSE Advisory Committee Transcripts 10/25-26/01

November 26, 2001 http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm

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Until recently captive bolt stunning that injects compressed air into the cranium was commonly used to disrupt the brain structure and induce total and prolonged unconsciousness, which is intended to insure that cattle are slaughtered in a humane manner. However, air injection stunning has been shown to force large pieces of brain, micro-emboli, into the circulatory system of stunned cattle. These brain micro-emboli lodge in edible tissues, for example the liver. Studies have shown that when correctly used, captive bolt stunning without air injection also induces total and prolonged unconsciousness and can be used to effectively slaughter cattle humanely without creating the micro-emboli in the circulatory system. The industry is aware of this and an informal survey of common stunning practices by the industry has revealed that virtually all plants have stopped using air injection stunning at this time. I say virtually all, I won't say absolutely all. This is a large country and we have a lot of plants. Let's talk for a moment about dehorning. FSIS requires that the horns of horned cattle be removed. This is primarily a sanitation feature. Sometimes this process unintentionally exposes the brains of the animals when a mechanical device is used to remove the horns. This doesn't happen routinely, but it happens on occasion. And although the potential for contamination of head meat with brain material in this way is considered slight, it need not occur if care is taken when horns are removed. When the horns are normally removed it will expose the frontal sinus of the cattle skull. It will not expose the brain unless a wider area of skull is removed when the horn is removed. Now in rare instances the skulls of cattle are intentionally split to remove materials contained within the cranial cavity, such as pituitary gland, and this is for non-human food purposes. However, in these instances the head meat is removed before the skull is split, so the head meat would not be contaminated by this route. Carcass splitting, we are moving down the line now, the animal is being subjected to continuing processes in the overall process of changing animals into edible product. Carcass splitting, on the slaughter line the vertebral column is split using a power saw, something like a band saw. Spinal cord tissue can be transferred to meat during this process. During this process the saw must be effectively rinsed between carcasses and the saws do have a built in rinsing mechanism. If they were not rinsed between carcasses you would run the risk of transferring spinal cord tissue between carcasses, from one carcass to the next. Now I am using the term transfer here rather than contamination, although you might hear me say the word contamination again, because I need to illustrate this fact. CNS is edible material and to date, historically, we have not had a reason prior to the introduction of BSE to consider it to be inedible material. Some people like CNS material. They go out of their way to find it so they can eat it. Brains and spinal cord, when collected in a sanitary fashion from inspected and passed carcasses, are wholesome and they may be sold for human consumption if properly labeled.

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DR. BOLTON: I want to welcome our former Chair, Dr. Brown. I saw that he has a question. Paul? Wake up over there Paul (laughter). DR. BROWN: Believe it or not I am awake. Granted the U.S. has close to a zero likelihood of seeing BSE if precautions are followed, other European countries of course felt the same way before they had BSE, and i there any reason for example why the slaughter houses in this country could not, as they do in Europe, although they don't in England, remove the spinal column, that is make two cuts and not one cut. Not the spinal column, I should say the vertebral column. There's no way, even with advanced meat recovery, that central nervous system tissue and its para-spinal ganglia can be guaranteed to be removed from a carcass short of not using the vertebral tissue, the vertebral column. is no And in this press that is used to squish out recovered meat there possibility to guarantee, short of removing the vertebral column, that some component of either residual spinal cord or para-spinal ganglia can find its way into mechanically recovered meat. So it would seem to me that if it were not terribly difficult to do, and apparently it is not because most of the European Union countries are doing it, that this would not be a bad thing for the slaughter house business to do. And the second thing of course is simply to stop using any kind of meat pudding which goes under the legal definition of meat, which was certainly the villain in Europe, and if we ever got BSE, would almost certainly be the villain in this country as well.

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Agenda Item: Committee Discussion and Votes DR. BOLTON: Thank you Dr. Brackett. I think we could fairly quickly deal with the first two questions before we again begin to broaden our discussion. The first question, what is the public health risk to consumers that would warrant consideration of prohibiting the sale of bovine brain and products containing brain for human use. I would suggest that the presence of undiagnosed or pre-clinical BSE in U.S. cattle could certainly be the public health risk to consumers that would warrant that. It is a big step and perhaps a large and controversial statement to move down that road. However, I guess I view this in two ways. I am very comfortable with our freedoms in this country, that if somebody wants to go out and knowingly purchase bovine brain and eat it, I guess that is their business. I'm uncomfortable with somebody buying hamburger thinking it is meat and finding out that it has some CNS tissue in it, and I'm uncomfortable with somebody buying a dietary supplement unknowingly that contains brain or CNS material that may or may not be labeled so that the consumer would understand the risks that they are taking. So I would open that up for discussion, and secondly, the question is there a consistent and appreciable difference in infectivity in various sections or areas of bovine brain, I believe that the studies indicate yes, that there are differences, but I'm not sure how good the quantification is, so somebody else may have to remind me of that. Steve, you may know, or Paul you may remember. So I think those two questions are not particularly controversial, but let's open these up to committee discussion. DR. GAMBETTI: I think a very important point to be able really to discuss the first question is to discuss an issue that at least has not been discussed so far with Dr. James. That is the surveillance. In other words, how, in order to really assess the risk on consuming certain ruminant product, I would like to know what is the current state of surveillance on BSE in the United States.

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DR. STRONCEK: You know I guess we, the country tends to regulate cigarettes as saying that there are certain risks and consumers can take that risk if they choose, but blood we don't really regulate it that way. We test it extremely well and we make it, we really make sure it is very safe. I think people would expect food to be the same way. They want food regulated as blood, not cigarettes, saying oh sure you can go ahead and eat brain, but you may get, you know, some disease from it. I think they would expect that it is very safe or it is tested to insure it is safe. And I'm not sure doing this surveillance, even if we do a lot of surveillance, cultures of cattle brain at the time of slaughter, it might be too late by the time we pick up that BSE is in the country. So it may be more prudent just not, to ban the use of brain from food products.

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DR. ROOS: I think Paul is right that what is relevant here, or at least one of the important relevant issues, has to do with dietary supplements, and I think he is also right that we've kind of talked about this several times over the last year, and I think we can forget it and just kind of answer this question, or we could deal with it a little bit more. I'm disturbed by the response, by the last comments of the individual from the FDA, as I have been disturbed each time I hear about the dietary supplements, because there is a question in my mind whether at the moment we have dietary supplements with bovine derived products from BSE countries. And I think that we should take this opportunity to take a stand on that. I mean that is at the top of our concern here with respect to protecting the United States from BSE and variant Creutzfeldt-Jakob, and I get the distinct impression that there is uncertainty at present whether in fact today on shelves there are dietary supplements that have bovine derived material from BSE countries. Now maybe the FDA can reassure me about this, but I didn't hear that. In fact what I heard was there was uncertainty at present in the system and that to me is very disquieting and I think we need to address this and maybe this is the appropriate time to do that. DR. EWENSTEIN: Well I make a couple of points. First of all, you know, I've gotten less and less confident with this distinction between BSE negative and BSE positive countries, because I could have had a pill, you know, your gram of brain, from Japan last month, and now suddenly it is not acceptable, and tomorrow it will be the pill from somewhere else in Asia. So you know, yes if you could specify the herd and you could really do the whole provenance of the drug it would be great, but you can't.

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DR. BROWN: Yes. There are two or three important points that were just made. First that we cannot, if we look at a map of countries of the world and look at the countries that imported meat and bone meal and a lot of cattle during the 1980s, it is almost worldwide, and Japan is a wonderful example. Now they have turned up a couple of cases of BSE, they will probably have a handful more, who knows what they will have. So the previous comfort in distinguishing between BSE free and BSE non-free countries is disappearing. That's point one. Point two is we can never be totally sure that mistakes won't be made at ports of entry. The example was given several months ago of a large shipment that came into an eastern port that was labeled pesticide, and it was suspiciously large. The Immigration Service decided to open it and discovered it was meat and bone meal from a European country. It was labeled pesticide because it was going to be spread on fields to prevent deer from grazing. Deer don't like meat and bone meal. So that was a leak, that was a hole in the dike, and that can happen anytime. So it seems to me that given what I think is a virtual total absence of any utility of brain, nervous system tissue, eye tissue, and distal ileum, which are the only tissues that have so far been shown to be infectious from BSE infected cattle, it wouldn't be a bad idea for this committee to simply flat out say nothing containing these products should be used by Americans. DR. BOLTON: No products containing those tissues, right. Dr. Brackett? DR. BRACKETT: Yes, I just wanted to respond to Dr. Roos and make it clear that dietary supplements currently allowed legally in this country may not contain meat products from BSE positive countries. Now that doesn't, you know, that doesn't answer the possibility for mistakes or illegal smuggling of those products in, but they are not allowed. DR. BOLTON: But given the problem, an example of the type of problem that I think was just brought up, and that is a brain coming from a known BSE country, being imported into a third non-BSE country that may or may not have strict import regulations, being then transformed into a dietary supplement and shipped from that country which is BSE free to the U.S., I believe would not be picked up by current surveillance and regulatory mechanisms. Is that correct? DR. BRACKETT: I think that is correct.

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