U. S. Department of health and human services public health service food and drug administration

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Linda has another point.

DR. DETWILER: Yes, I can even go one step further. Now in the last year in conjunction with the FSIS and the renderers association and APHIS that the -- well, first, to do the edible. The CNS condemns are kept out of the human food chain and the edible food chain.

Now when they're condemned, the CNS diseases -- and this would be adults, so I'll quality this, adult cattle condemned at slaughter. We have made an effort in the last year to do one of two things with those carcasses. One, have them incinerated right away after the samples were taken for diagnosis, or two, hold them, tag them until CNS disease and the TSE can be ruled out. That's what we're doing now throughout the country to rule out that possibility in cooperation with the renderers and FSIS.

CHAIRMAN BROWN: It might help the Committee tomorrow -- I think it would help me -- if we could get someone from the FDA to just give us a slide with a couple of examples, if they exist, of a situation in parallel between a source of gelatin and a product made from gelatin, and a source of tallow and a product made from tallow. I'm not entirely clear at the moment.

It looks to me as though the FDA currently is dealing with tallow, just as they are dealing with gelatin. That is that there are restrictions from FDA countries. That was our business the last time. We took away the exemption that gelatin enjoyed with respect to BSE countries. It looks as though we're being asked a similar question with respect to tallow. Not an identical question, but a similar one.

DR. ASHER: There's no current exemption for tallow.

CHAIRMAN BROWN: Right. That's what I say, there's no current exemption for tallow. So, tallow currently is just like gelatin which has no exemption.

DR. CHIU: Right now there's no exemption for injectable gelatin because of the --

CHAIRMAN BROWN: Okay, well, this is the sort of thing that's very difficult for me to absorb by a microphone. I'd really like to see a couple of examples on a slide showing me the difference between a tallow and a gelatin product, injectable versus oral versus something else so that I can get a handle on what the situation with gelatin is now. If I were smarter, I'd have it all in my head. But it would help me a lot to see this kind of a comparison with two or three examples, so we know what we're dealing with a little more concretely.

I mean is everybody in the Committee clear on exactly what the situation with gelatin is, injectable, oral, cosmetic versus tallow?

DR. LURIE: I would take it further than that. I don't think we need two or three examples. I'm thinking of a fairly complicated table, really, that lists --

DR. BURKE: That's what I started to do here and that's what got me confused. I couldn't draw the table.

CHAIRMAN BROWN: So, it looks like we're all in the same boat. I'm afraid we're all human. I think the problem here is that the question and the subjects are similar but they're not identical. We're having a little trouble determining the differences. I think we could answer these questions if we didn't have to worry about gelatin lurking in the background ready to slay us if we make a mistake.

Is there a gelatin manufacturer in the audience who wants to make a comment?

MR. SALMONA: Thierry Salmona. I'm president of the GME.

I just wanted to make two comments to answer a question which was asked just one minute ago. First of all, only animals found fit for human consumption having undergone ante and post mortem inspection are allowed to go into the gelatin raw material, okay? So, there is no possibly animal found diseased which can go into the raw material for gelatin, okay? This is true for the gelatin imported into the United States. It's also true for the gelatin made in Europe and sold in Europe, okay? It's a general rule applied by the gelatin industry, okay. That's number one, and it's mandatory in tallow.

CHAIRMAN BROWN: Is this all disease, or -- I'm sorry, was it any diseased animal?

MR. SALMONA: All disease, any disease. It's only animals found fit for human consumption in the slaughterhouse after ante and post mortem inspection by the official veterinarian service which are allowed to go into the gelatin manufacturing raw material.

CHAIRMAN BROWN: Are there any disorders, Will, of cattle which are thought to not compromise human suitability? I mean, does a cow have to be absolutely normal before it is considered fit for human consumption, or can he have a rash?

MR. SALMONA: It's just a cow which is considered good for meat. Then it is considered good for gelatin, the same criteria.

CHAIRMAN BROWN: Right, and that's the point to my question.

DR. HUESTON: So, you're saying only materials from only edible carcasses are going in a gelatin manufacturer in Europe right now?

MR. SALMONA: Absolutely. Absolutely. This has been the case for years. Okay, there is no material which is not coming from an animal from which you can find your meat at the butcher shop which is going into the gelatin raw material. It's the same raw material as meat, except that we take bones and skins for gelatin and meat for meat. It's the same raw material, same animals. If an animal is discarded for meat, it's then discarded for gelatin. You can not use animals which are not considered good for human consumption to manufacture gelatin.

DR. HUESTON: Is there a gelatin industry then for non-edible?

MR. SALMONA: There is -- yes.

DR. HUESTON: And industrial gelatin --

MR. SALMONA: Yes. Yes.

DR. HUESTON: -- is that based from materials coming from non-edible?

MR. SALMONA: Yes, practically yes.

DR. HUESTON: You're saying yes and one of your people in the audience is saying no, so I'm getting two messages.

MR. SALMONA: No, no, no. I'm sorry. The message is as following. There is gelatin which is made for industrial purpose: photographic gelatin, glue, matches, et cetera, et cetera. So, there are some uses which are not edible, okay?

In theory, for this gelatin, you could use different animals. In practice, what is happening is the same manufacturers import the same bones and therefore, also for this use, in the enormous majority of cases, these animals are found fit for human consumption as well.

DR. HUESTON: But the hides, are you telling me also that only hides from animals passed for human consumption are used in making gelatin, soft gelatin --

MR. SALMONA: In Europe, there is a regulation which prevents hides coming from the rendering circuit. So, hides coming from animals not fit for human consumption to go into what we call low risk factory, which are gelatin factories. These hides coming from animals found diseased have to go in special factories in which there are basically not incinerated but transformed according to the rendering practices and then sterilized.

So, in Europe, there is a regulation which prevents these hides to go into the circuit. A tannery in Europe can not possibly accept material which is not coming from animals fit for human consumption. Because a tannery is not a high risk factory and we have this classification, high risk and low risk.

CHAIRMAN BROWN: Do the same guidelines apply to tallow?

MR. SALMONA: I'm sorry. I can not answer for tallow.

CHAIRMAN BROWN: Do the same guidelines apply to tallow?

MR. SALMONA: I can not answer to tallow. I'm not in the tallow business.


MR. SALMONA: I wanted to make a second comment to the question which is, it has always been the usage in industry to use material coming from country with no native case of BSE for parenteral use. Therefore, we have not made any comment in this part of the guidance of the FDA because this has been common practice.



MS. HARRELL: Okay, I would like for you to come back to the microphone, please?

When you said there was a post mortem done, is that done on each animal or a sampling, or a sample post mortem from maybe a herd that's come in? Is that on each animal?

MR. SALMONA: Each animal is inspected, okay, by the Veterinarian Service at the slaughterhouse, okay? Animals which are not found fit for human consumption are discarded and then their product and co-product can not be used for any use including gelatin.

CHAIRMAN BROWN: I'm curious -- I don't guess we have enough time to get into it. We're moving further and further and further back into the guts of the thing, no pun intended. I'm wondering about just what goes on when a veterinarian looks at a dead cow with respect to his suitability, or her suitability for human consumption?

DR. BURKE: Or a confused cow.

CHAIRMAN BROWN: No. Well, I assume that this inspection is, I mean, like a USDA inspection. Or if a European inspection were occurring --

PARTICIPANT: Bob Brewer is here.

CHAIRMAN BROWN: Oh, yes, fine.

Just because we've got a little bit of time to play with, what would a packing house veterinarian be looking for?

DR. BREWER: Maybe I can do tomorrow morning's presentation now.


DR. BREWER: I don't have any slides so that would probably preclude me from doing it, actually.

Anyway, all animals are inspected in an ante mortem inspection in a USDA establishment and that's by the veterinarians, and that's all animals. Those animals are observed in motion and at rest. Then the animals are slaughtered and some of the animals -- 100 percent of the animals are inspected after they're slaughtered. If they pass the ante mortem inspection, 100 percent of them are examined on the post mortem. Now, in some of the large plants you have trained inspectors, lay inspectors under the supervision of the veterinarian making the examinations. If the lay inspectors have a question about an animal, it's railed out and those are examined by a veterinarian. So, they all have 100 percent inspection.

To reiterate what most of you said, anything for edible tallow is from an animal that's been inspected and passed for human consumption. If it's rejected, in no way does it end up in edible tallow.

CHAIRMAN BROWN: Of course you're not, I'm sure, inspecting the brain or maybe you are --

DR. BREWER: No, we do not inspect the brain.

CHAIRMAN BROWN: I didn't think so, or you'd be looking like a pathologist in a hospital. He opens the body, the lungs look okay, the heart looks okay, the visceral look okay, the muscles aren't atrophy.

DR. BREWER: If that animal has any abilities moving around, or if it indicates it has a central nervous system on ante mortem, it is not slaughtered. It is condemned and everybody in the slaughterhouse. As Linda said, heads are now removed and the brains are sent to Ames, Iowa and they're examined histopathologically.

CHAIRMAN BROWN: In your experience, what sorts of things do you miss?

DR. BREWER: Do we miss?


DR. BREWER: I'm sure we miss a lot of things. There are about 33 million cattle slaughtered in the United States each year. We have about 110 million cattle in the United States. The vast majority of the product is coming from animals that are less than 18 months of age. As Don touched on, you've got a number of plants in the country now that are killing 5,000 or 6,000 head of cattle a day. That's a lot of cattle, but those cattle are extremely closely monitored when they're loaded on the trucks.

It's not uncommon to get in some of these big plants -- I know one plant that kills 35,000 head a week and they average one condemnation a week because they won't haul the cattle more than 50 miles to slaughter. They don't want them -- these trucks bring in the cattle all day. They no longer have 1,000, 2,000, and 3,000 head of cattle wandering around in the corral waiting to be slaughtered. Some of these plants only have the capacity to hold 400 head of cattle at a time, so they're killing almost that many an hour. So, the cattle are coming in all day. They're loaded on the trucks in feed lots and brought in.

Now, I'm talking about the bigger plants, of course, obviously. I think by and large, this thing about how many cattle are missed that have the potential for BSE -- for the last ten years, there's been about 300 cattle condemned per year with central nervous disturbance on ante mortem. That's 300 out of 33 million cattle. This fluctuated just around that figure for at least the last few years.

CHAIRMAN BROWN: And you say these would be cattle that would be coming through and you would determine that in spite of the fact that they were sent to you, there was something wrong that might be neurologically related.

DR. BREWER: Right, right.

CHAIRMAN BROWN: So, the first screening, presumably, would be by the rancher himself who would --

DR. BREWER: Hopefully.

CHAIRMAN BROWN: -- yes, hopefully, would cull his staggering cattle. Then some would die, presumably, because they had a disease that killed them before they came to market. And a few, as you say -- 300 out of -- what did you say?

DR. BREWER: Thirty-three million, possibly --

CHAIRMAN BROWN: -- would escape this and come to the attention of the inspectors.

DR. BREWER: And as I say, these animals are examined both in motion and at rest in the corrals prior to --

CHAIRMAN BROWN: Yes, right. Well, in terms of neurologic disease, since you don't examine the brain, it would have to be pre mortem.

DR. BREWER: Yes, exactly.

CHAIRMAN BROWN: Question, Kiki, or comment probably?

DR. HELLMAN: Yes. This has been a very interesting discussion about slaughter practices. I think the question you raised earlier, Paul, on the request of having a charge showing the sourcing and the end product use of some of the products that contained gelatin and tallow is well placed. We'll try to get that tomorrow.

I would just like to bring the Committee back to the task at hand, to clarify and perhaps summarize. At last October's meeting, we dealt with gelatin. In our '93 recommendations and '96 recommendations, vis-a-vis a letter to the industry, we requested that materials from cows that had originated, resided or slaughtered in BSE countries not be used in FDA regulated products. Gelatin was exempt from that. At the meeting in October, we recommended that that exemption be rescinded so that gelatin is now included under those original recommendations. There are certain considerations that are going to be clarified tomorrow.

With regard to tallow, tallow had been included in the initial recommendations both in '93 and '96. So, now what we are asking is that should tallow be -- should the restrictions on tallow be lifted somewhat, vis-a-vis the processing and the other quality control assurances that are being put in place with regard to tallow and tallow derivatives. So, there --

CHAIRMAN BROWN: Yes, they're reversed. Yes, we're going in different directions.

DR. HELLMAN: -- are different questions. They're reversed. They're reversed.

CHAIRMAN BROWN: Yes, gelatin we were asked about the recision --

DR. HELLMAN: Right. That's right.

CHAIRMAN BROWN: -- and sort of talking about it. The focus of this is whether we should loosen it up.

DR. HELLMAN: Exactly. So that I don't think we want to confuse gelatin and tallow because they are different questions.

CHAIRMAN BROWN: Yes. Anybody want to ask a question about dura mater as long as we're --

DR. HELLMAN: While you have me here.

DR. CHIU: I would want to make a further clarification. Even though the question could be lifted the restriction, but the question could also be more restrictive. That would be you would require BSE free country, however the process has to be under certain conditions. So, that would pose additional restraint. So, it could go either way for tallow and tallow derivatives.

CHAIRMAN BROWN: Yes, I think that's a good point. We are not being guided to move in one direction or the other by the FDA. We could, as we've just heard, go in either direction or no direction at all. We could simply remain stable. But the wording is "justify a change". It could be a change to be more strict, less strict, or unchanged at all.


DR. DETWILER: I just have one addition to Dr. Hellman's comments. The USDA does prohibit the importation of gelatin for use in animal feeds from BSE countries, or from high risk countries. So, the exemption is human products.


MR. FAITEK: That was exactly a pivotal point in our discussion in April. The issue then was do we want to treat products for human consumption any differently than we treat products for animal consumption, and the answer was no. No importation of gelatin from BSE countries, period. That was my understanding of the decision that we reached in April.

CHAIRMAN BROWN: Yes, it might have been a little more subtle than that. We didn't say no, no, no. We said put it in the same bag with everything else for FDA consideration.

MR. FAITEK: Well, for example, the example that Dr. Detwiler mentioned.

DR. DETWILER: No, he was just making a comment.


DR. BURKE: The numbers that you gave of Drs. Taylor and Bradley earlier that there had been two million cattle that had been slaughtered. Of those, there were 170,000 were confirmed BSE cases. The others were slaughtered because they were part of herds? That's the first question. The second one is, could you comment on the experience in the UK on the sensitivity and specificity of a clinical diagnosis of BSE in a cow?

DR. BRADLEY: Well, that's quite a lot of questions here. Dealing first with the numbers. I haven't told you everything that's happening on BSE.

After the export ban was placed upon the UK by the member states, subsequently, there was a negotiation for release of the export ban. The first one, which is where the two million cattle came from, was the establishment of animals over 30 months which should be destroyed and their products not used for any purpose. In practice, some are incinerated immediately, but the capacity isn't sufficient to do that for all of them. Those that are not incinerated are first rendered and then they're stored in these big piles I mentioned this morning, pending incineration. That total is two million -- approximately a million a year. That's the rough figure.

On top of that, there were two other sorts of culls, or three actually. One is just being developed at the moment. There was a requirement to cull animals in the birth cohort of cattle where one animal in a herd in that cohort had succumbed to BSE. For example, we know that within herd incidence is relatively low with BSE. Still over 30 percent of herds that have had a case have only ever had one case. So, it's a very low incidence disease within herds in a general way. But in that group of calves that was exposed, which five years later one animal got BSE, there might be another ten or a dozen calves still around on that farm or on other farms.

Now, this is a cohort cull which totally amounts to about 100,000 animals. Of course, the great difficulty is tracing these. But when they're traced, they follow the same route. Basically, they have to be destroyed and not enter any feed chain. So, we're up to about -- I think the figure is something over 50,000 that have been found and actually killed in Great Britain out of an approximate 100,000. But some of those animals that haven't yet been found have been killed for other reasons. Either the farmers killed them anyway or -- and the farmer has gone out of business so you can't trace them anymore, or they've been trapped by the other scheme.

There is a third scheme wherein before the export ban, we were exporting calves from any herd to the continent of Europe, to other member states, about half-a-million a year. The rules were that they must not be offsprings of cattle with BSE and they must be killed in their country of destination before they were six months old. Then they would be for veal, of course, which would be for human consumption. There would be no offals removed from those animals in the importing country.

Because this trade vanished, there's been compensation paid to destroy these as well. I can't remember just the exact number, but we're talking about hundreds of thousands of animals.

Finally on this, because of the potential for maternal transmission, this is a proposal to identify offsprings of cases born after the first of August, born in animals that developed BSE after the first of August 1996. And that's just sort of the beginning to try to find such animals and destroy them. It would remove just a few hundred animals that potentially might come down.

DR. HUESTON: Can I interrupt for one second because I'm afraid you may be expanding the confusion.

CHAIRMAN BROWN: Yes, I think so.

DR. HUESTON: Just let me start by saying the 170,000, that is the total number of confirmed cases of BSE. It has nothing to do with any of these numbers you're hearing now.


DR. HUESTON: It's entirely different.

DR. BURKE: But it does go into the two million numbers?

DR. HUESTON: No, nothing to do with the two million.

DR. BRADLEY: No. No, no, no.

DR. HUESTON: The 170,000 is from the very beginning. From the first case that was identified to today, there have been 170,000 confirmed cases meaning they've examined the brain and confirmed the disease. All of these things that Ray is talking about now are preempted culls of normal, apparently healthy animals as a preemptive measure to speed up the down -- end of the epidemic and restore public confidence.

DR. BRADLEY: Absolutely so. But on top of the 171,000, these are the confirmed cases.

Now, your other question was the specificity of the clinical diagnosis.

DR. BURKE: Actually, I'm more concerned about the sensitivity of the clinical diagnosis.

DR. BRADLEY: Okay. Well, each animal that is suspected to have BSE is compulsorily slaughtered and the brain examined. Throughout the epidemic, the average confirmation rate is 85 percent which is really very good. Of the remaining 15 percent, about 45 percent very roughly -- say almost half -- have an alternative diagnosis. It can be all sorts of different things: cerebral listeriosis, tumors, abscesses, tape worms, et cetera, et cetera. The other 50 percent have no detectable lesions. This number, this percentage, 15 percent, is now declining.

DR. HUESTON: Yes, that's the predict -- that relates to specificities predicted by -- tests is 85 percent.

DR. BURKE: The reason -- I'm sorry for taking as much time on this as we are, but a lot of this goes into whether or not a diseased cow -- whether or not that adds anything at all to the screening value of protecting the overall -- the materials that go into the processing. How sensitive is that for picking up an animal that might go into the pool? Specificity isn't the answer. Sensitivity is one --


DR. HUESTON: And that was part of the justification for the ban on all animals over 30 months of age because based on the pathogenesis study, you could not detect these infected tissues. Well, the ban on specific infected tissues was based on the pathogenesis studies. So, it was to take out all tissues that could, in the extreme case of massive oral exposure, demonstrate infectivity. Those were removed from the whole manufacturing change. Then they carte blanche took everything over 30 months of age, which meant they took animals younger than what they could create the disease experimentally with this massive oral dose. That was the basis around it.

DR. BRADLEY: I think all these extra animals, of course, are not allowed to have any of their tissues used for tallow, gelatin or anything else, and that's the point. It's all a preemptive public health --

CHAIRMAN BROWN: Yes. They're now ashed, is that right?

DR. BRADLEY: Exactly.

CHAIRMAN BROWN: Yes. It occurs to me if you gathered that ash and put it in suitable containers and labeled it as napalm, you could sell it to the US Navy and it could travel around the US incognito by train for the next ten years. I don't know if you know that story or not.

I think we can wrap things up. I'm glad we got some of these knotty problems brought up before the day is out. I'd prefer that they be introduced today than wait until tomorrow when I think, as is usual, we will come to the moment of truth and find ourselves still perhaps on the fence about one thing or another.

It is now 4:30. We will conclude today's proceedings now and convene again at 8:00 tomorrow morning.

DR. HONSTEAD: Paul, can I make one comment?


DR. HONSTEAD: One real brief comment to build on this excitement here. I think you can see how exciting and interesting it is to discuss TSE risk. It's very, very challenging.

I also want you to realize that after this two days, the audience in this room is going to be some of the top experts on TSEs among the world's population of people. So, you will have a great background in this. I challenge each of you to come to the symposium, the workshop on TSE risk at the University of Maryland in June, because you have a great deal to contribute now -- you will go home and think about this for a couple of months and it will even be better.

The organizers of the Committee are both here in the room. It's Dr. Will Hueston from the University of Maryland and Dr. Kiki Hellman from FDA. I think that this risk workshop can only build on these very issues that we're talking about.

CHAIRMAN BROWN: Thank you, John.

John used to be a scientist and he's now a public relations officer.

DR. FREAS: I would like to remind the Committee members that some of the material that was passed out today is confidential. I am required to take all the confidential -- anything left on the table and shred it. So, if you want the material, please take it with you.

(Whereupon, the meeting was adjourned at 4:24 p.m., to be reconvened at 8:00 a.m., the following day.)
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