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



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Tallow and grease production and uses in the United States: these figures are just somewhat of an average taken by the US Census Bureau. They don't change a lot from one year to the next. Production of inedible tallow, as you can see, is 3.5 billion pounds per year. Inedible grease is 2.8 billion pounds per year, for a total of 6.3 billion pounds. The reason we take it together is because of the uses. It's not broken out into tallow and grease, so we have to sum them together.

Consumption in soap is about 250 million pounds per year. That has stayed somewhat steady I think mainly because they have been using a lot of edible tallow. Most of that is tallow and a small percentage of all hog choice white grease. Feed, our largest consumer is 2.2 billion pounds per year. A good portion of that is choice white grease. Lubricants, 85 million pounds per year and that would be for the rolling oil industry for steel manufacturing. Fatty acids, 625 million pounds per year. That has been steady for about the last four or five years also, mainly because they also are utilizing more edible tallow. Other products would be approximately 790 million pounds per year and some of that would also be pet food. Ending stocks are approximately 350 million pounds per year. Exports which are about two billion pounds per year contribute about a half-a-million dollars to this country's trade surplus.

The typical bleachable fancy tallow specification for sale to the fatty acid industry is as follows: titre of 40.5 degrees Celsius minimum; free fatty acid of four percent max; FAC color of 19; refine and bleach, as Mike was saying, is another indication of the color of the fat. It's mostly a soap specification. Moisture is 0.50 percent, and an impurities of 0.25 percent. Anything out of those last two specifications is rejected if it gets there and it's above those levels.

I know everybody is concerned about the imports of edible and inedible tallow. These come from the Trade News Service which gets them from the US Census Bureau. As you can see, edible tallow imports -- this is metric tons. A metric ton is 2 million, 404.6 pounds per metric ton. As you can see, when compared to the total production in the United States, it's a very small percent that's coming into this country and it's all from Canada.

U.S. imports of inedible tallow in metric tons on a yearly basis. As you can see, Canada is the largest exporter of tallow into the United States. Once again, when compared to our total production, it's very small. I think a lot of these other smaller ones like Germany and Sweden -- I think it's material that's coming into the country that's probably just mis-marked as far as the tariff considerations are concerned. New Zealand could be mutton tallow for the pet food industry also.

Exports of tallow and grease from the US. On that previous slide, we had Mexico on there just to show you we don't get anything in from Mexico. Our largest export market, I think at this time, is Mexico. We probably export, I think, 150,000 to 180,000 metric tons of tallow and grease to Mexico per year. The average figure there is about two billion pounds. Like I said, it represents about a half-a-billion dollars to this country's trade surplus.

As long as we continue to produce animals in this country and feed the world, we're going to have an excess in this country of tallow and grease, and we're going to continue to have exports of these levels. I would expect the 1998 figure to still be up there -- back up to around that two billion pound figure.

Insofar as prices are concerned, we are a cash commodity which makes our job just a little bit tougher. We fluctuate with supply and demand. These are our prices. We have about two or three different market sheets. One is the USDA, Jacobsen Publishing, and also the National Provisioner. These are prices as taken from Jacobsen Publishing which are very close to the USDA sheet. As you can see, our prices do fluctuate quite a bit.

Bleachable fancy tallow prices move in pretty much a direct relationship with edible tallow since they are related. The next slide would be a monthly average. Prices at this time are around 14½ to 15 cents. So, you can see our prices do go up and down with supply and demand.

That's about all I have for my presentation. If anybody has any questions, I'd be happy to answer them.

CHAIRMAN BROWN: Does anyone on the Committee have a question? Yes?

DR. BURKE: I'm having difficulty going back and forth between metric tons and millions of pounds.

MR. KILANOWSKI: You take metric ton as 2 million, 204.6. So, if you've got 29,000 metric tons, you've got approximately 61, 62 million pounds.

DR. BURKE: Okay. Can you help me just in terms of the relative proportion of the total tallow which is domestically produced to the amount which is exported and the amount which is imported with some common denominator?

MR. KILANOWSKI: Okay. You've got about 6.5 billion pounds produced in the US. Two billion pounds of that is exported.

CHAIRMAN BROWN: Again, so about a third?

MR. KILANOWSKI: About 30 percent.

CHAIRMAN BROWN: Twenty percent, about 30 percent is exported?

MR. KILANOWSKI: Yes, is exported.

CHAIRMAN BROWN: And what proportion of --

MR. KILANOWSKI: Now, that's total tallow -- 6.5 billion pounds is tallow and grease, choice white grease.

CHAIRMAN BROWN: Right. And about 30 percent of that total is exported?

MR. KILANOWSKI: Is exported, correct.

CHAIRMAN BROWN: In view of that -- and maybe this was your question, what is the purpose of any imports?

MR. KILANOWSKI: Well, it's coming in -- as you can see, the imports that were coming in are coming in from Canada.

CHAIRMAN BROWN: Yes, why?

MR. KILANOWSKI: Their markets are -- well, we also send tallow to Canada, part of NAFTA.

CHAIRMAN BROWN: Yes, so this is just a kind of a historical quirk and a market phenomenon where even though the total amount of tallow and grease that we produce is more than enough for ourselves, we still find ourselves importing for various reasons, a small amount from Canada and even less from other countries.

MR. KILANOWSKI: Right.

CHAIRMAN BROWN: Okay.

DR. BURKE: Again, can you put some number on that? I still haven't made the calculation myself. What percentage of the total tallow production in the United States is from imports?

MR. KILANOWSKI: I don't have a calculator with me, but approximately, I think, total imports are about 60 million pounds.

DR. BURKE: Sixty million out of 6.3 billion?

MR. KILANOWSKI: Yes, out of 6.5 billion pounds.

DR. BURKE: So, of the total tallow, we're talking about less than a half-a-percent or a 10th of a percent, roughly?

MR. KILANOWSKI: Right.

DR. OLANDER: One last question.

CHAIRMAN BROWN: Oh, I'm sorry. Yes, go ahead. Why don't you go ahead?

DR. OLANDER: Is there any trans-shipment through Canada from other countries?

MR. KILANOWSKI: Not that I know of because Canada also exports to other countries, also. Canada exports quite a bit to Korea, China, Germany -- where else? Quite a few different countries. The only reason it probably comes in here is because those markets like Southeast Asia has been hurt so bad. So, some of that has been coming into this country because our domestic usage over the past -- oh, since about May or June of '94, our domestic use has just been very good and exports have been on the decline here for the last two or three years. But that is going back up again.

DR. OLANDER: But you're not sure as to whether there is or isn't trans-shipment into Canada?

MR. KILANOWSKI: I'm not sure. I can't tell you that for sure.

DR. OLANDER: Okay, that's fine.

MR. KILANOWSKI: I doubt it though.

CHAIRMAN BROWN: Anybody in the audience know the answer to that question?

Ray?


DR. ROOS: On this overhead, it lists feed?

MR. KILANOWSKI: Yes.

DR. ROOS: So, that's animal feed in this country and what kind of animals?

MR. KILANOWSKI: Mostly poultry.

DR. ROOS: Cattle as well?

MR. KILANOWSKI: Poultry, cattle -- yes.

DR. ROOS: Okay. And that's still allowed? I thought there was some restriction on --

MR. KILANOWSKI: Just on the meat and bone meal.

DR. ROOS: Just on the meat and bone.

CHAIRMAN BROWN: What form is that? I mean, you don't obviously ladle out pure grease to an animal to eat, I would think. What kind of a product is that feed, I mean when tallow ends up as a feed?

MR. KILANOWSKI: It's an additive. It's an additive to the feed.

CHAIRMAN BROWN: Mixed in with everything else, meat and bone meal and whatever else they're getting.

MR. KILANOWSKI: Right.

CHAIRMAN BROWN: Yes?

DR. BURKE: Can you say something again -- a little bit more. You said that maybe these really weren't from Germany or from Sweden?

MR. KILANOWSKI: Well, what I'm saying is that I think it's not really tallow that's imported into this country. It's probably some sort of a derivative but it comes in under a tallow tariff. Because I think it's kind of silly when you have imports of one ton.

CHAIRMAN BROWN: Thank you.

Now, we will move to the next speaker who is David Taylor. Who I guess, to the best of my knowledge, has performed the only published experiments on inactivation of the TSE agents that imitates or tries to duplicate, or is a scale-down process of rendering itself as opposed to a number of other kinds of inactivation studies which have not tried to duplicate rendering. So, David Taylor is from the Institute of Animal Health in the neuropathogenesis unit in Edinborough, Scotland.

Welcome, David.

DR. TAYLOR: Thank you very much, Paul. Thank you to the FDA for the invitation to come and speak to you.

Could somebody switch the projector on for me, please? Thank you.

Well, we see here the epidemic curve of BSE within the UK. We see that it was a down turn in 1993. This down turn was a direct cause of intervention in 1988 where there was a ban on feeding ruminants with ruminant derived protein. This was on the back of epidemiological studies carried out by John Wilesmith at the Central Veterinary Laboratory in England who, having surveyed a whole manner of potential risk factors, concluded that the only risk factor he could find for BSE was the feeding of meat and bone meal. So, we had the ruminant to ruminant feed ban introduced in 1988. The delayed effect is simply a reflection of the fact that the average incubation period for this disease is around five years.

Now, although we had the feed ban in 1988, we still have had a significant number of cases of BSE in animals born after that feed ban. In the case of those born in the period relatively soon after the feed ban, this was understandable because the ban had not included any measures to seize and destroy food already in existence. On the other hand, there were a disturbing number of animals came down with BSE that were born some considerable time after the ban.

By May 1997, I don't know the count figures -- we had 106 SI and we had 32,000 odd cases born after the ban. As I said, many were born just after the ban. But what was discovered later was that the social infectivity for a number of these animals was cross contamination of ruminants by poultry and pig diets being manufactured in the same factories. Now, this should not have mattered because at that time, there was in place the specified bovine offal ban which should have removed all risky tissues and abattoirs. But what was discovered was that that regulation was not being very well policed at all. So, theoretically, BSE contaminated tissues could be getting into pig and poultry diet and then cross contaminating cattle feed.

Under the nice bit of information that John Wilesmith put together on this was that if you divide the UK up into different geographical locations and look over the period from the late '80s into the '90s, you can see that in this region and in this region here, the incidence of BSE was actually accelerating. Whereas in most other areas, it was either relatively static or was, in fact, declining. It turns out that the north and the east are the areas within the UK where there's the most intensive pig and poultry farming. So, we've fairly good evidence that although the feed ban had a major effect and should have been more effective, there was some leakage into the system.

Now, in addition to John Wilesmith's theory about meat and bone meal, quite adequately confirmed by the down turn in the epidemic, it was decided around 1990 that we should conduct validation studies on the rendering systems used throughout the European Union. Surveys were carried out to determine what range of procedures were in existence, to define the time/temperature characteristics, to define particle size parameters, et cetera. A fairly major task, but after a fairly hefty effort by a large number of people meeting in Brussels on many occasions, we found that the processes could be defined, as you see, under these genetic headings. From traditional batch systems to the newer continuous systems which operated either in atmospheric pressure or under vacuum, systems called wet rendering cooking either in the natural fat content or adding pre-heated tallow at the beginning of the process, and batch pressure systems.

I should say that of these batch pressure systems, the only one that was actually being operated in Europe was this one here. The other two were included as fall-back options in case everything else should fail. And so, using actual rendering equipment, albeit pilot scale equipment but genuine rendering equipment, we spiked large volumes of abattoir waste, in one case, with BSE infectivity, and in another series of experiments with scrapie infectivity.

I won't go into all the fine detail of the different processes. I would just comment at this stage, as a follow-up to comments made earlier on, that my understanding is that the range of techniques used throughout Europe are not that dissimilar to those practiced in the United States. Indeed, the equipment used to carry out these types of processes in many cases, again I understand, were probably imported from the United States. This does not, of course, mean to say that the equipment would be used in identical fashion, but I think that is likely. Somebody may wish to comment on this later.

So, we carried out these experiments. The experiments were actually done, apart from this one, in pairs where we, on the basis of the genetic grippings for these processes, we defined minimum and average conditions, minimum average -- the exception the batch on the steam under pressure system. In the case of the BSE spiked experiments, when we studied the meat and bone meal output samples by assay in mice, with the BSE spiked material we found infectivity in four of these samples. Now, the BSE run was the first one to be done. As a mentor measure, when these results were submitted to Brussels, they put in place an interim decision which was to first of all, outlaw this system here. Because when we did titration of the infectivity titres, we found that there was, in fact, very little inactivation of infectivity at all in these meat and bone meal samples. And they redefined some of the time/temperature conditions applying to the other processes.

When we completed the scrapie spiked studies, we found that, in fact, all of the output meat and bone meal samples were positive except for those produced by these systems using steam under pressure. Now, I should say that this is not evidence that scrapie infectivity is more thermostable than BSE infectivity because I would draw your attention to the fact that the amount of infectivity per gram of spike material that we managed to get in in the BSE run was just less than two logs per gram. Whereas, in the scrapie run, we might see it over three logs. So, the loads were different. One is not entitled to conclude, make any comments about thermostability between BSE and scrapie on the basis of this.

We did look at a limited number of tallow samples which I'll just mention briefly. The reason that the number of tallow samples was limited was because John Wilesmith, again in his 1988 paper, had already concluded that the nature and use of tallow in cattle feed did not equate with its known distribution, its commercial distribution in the UK. So, he, in 1988, he had looked at and excluded the possibility that feeding tallow was linked to the BSE problem.

As a result of the scrapie data, the EU issued this decision which, in essence, said as from April steer, countries within the EU that were manufacturing meat and bone meal for use in any animal diets -- and be reminded, there had already been a ruminant protein ban placed in Europe since 1994. But people manufacturing meat and bone meal for inclusion into other species would thereafter have to use the process that I described here as the under 33 degrees process using steam under pressure for 20 minutes.

Just one anecdotal little bit of information that came from the rendering experiments. In one study where we ran the process at 72 degrees Centigrade -- and I should say that this is not normal rendering. I don't need to explain the background,b ut we did run one process at 72 degrees Centigrade under vacuum. With scrapie, we lost 2.3 logs of infectivity. Now, traditional studies in the past using these temperatures at the atmospheric pressure would suggest that the loss of infectivity within this temperature range is actually much less than that. In contrast, when we used the same equipment at atmospheric pressure and allowed the temperature to rise to 120-ish degrees Centigrade, the infectivity titre was reduced by a significantly smaller amount.

I would just say that this data actually fit in with a number of other bits and pieces that we're collecting now, suggesting that things which aggressively and rapidly heat fix the disease specific form of the PRP protein, are likely to protect that from inactivation by heat processes and this in fact would -- this being under vacuum in a boiling of water here at temperatures below 100 degrees Centigrade. So, that's just an anecdotal side issue here.

Now, although the studies suggested at the 133 degrees Centigrade steam sterilization process was effective, the reasons for saying that in every day rendering, that might not be the case in worst case conditions. The reason I say this is that within the experimental rendering studies, we made every attempt to make sure that the brain material that we were adding to the bone and offal, et cetera, was thoroughly mixed in with that material. The reason being that we, of course, at subsequent stages wanted to take sub-samples and test for the level of infectivity. Of course, if it had been just distributed unevenly throughout the batch, these measurements wouldn't have meant much.

These red dots speculate on the distribution on the infected bits of tissue with the large dark pieces of raw material in experimental rendering. I would venture to suggest to you that in every day rendering, as an infected brain enters the crushing and then the rendering process, that infectivity in that brain or the brain tissue, by the end of that process, is not going to be distributed in that fashion throughout the raw materials, but will be much more like this. In that case, if that is the case, one has to worry about the fact that the scrapie certainly -- for example, Bill Hadlow's study showed that over a complete scrapie infected brain, the infectivity titre could be 106 logs, and in some discreet parts of brain, you could get levels of infectivity up to 108 logs per gram.

The fact that I'm suggesting that infectivity is distributed like this in real life as opposed to this, to my mind is also borne out by the fact that the field evidence would suggest that meat and bone meal was not homogeneously infected, but you had clumps of infectivity, explaining why we have quite a number of herds with only one, two, or three cases. This would all fit with this idea of non-homogeneity. There's also data already in the literature which shows survival infectivity and ten percent being homogenates infected with scrapie after 132 degrees Centigrade, steam under pressure for an hour from Maurizio Pocchaiari and also from Ernst & Race here at the Rocky Mountain lab. And I have data showing survival after 132 for an hour, or 134 for an hour with undiluted brain tissue.

Now, on to another aspect of rendering which was mentioned earlier on. Unlike the United States, the UK did use for quite considerable time, solvent extraction as an adjunct to rendering. In other words, already rendered material was then exposed to solvent extraction process, both to enhance the yield of tallow and to produce, at one stage, a low fat meat and bone meal which attracted premium prices.

What was observed was that during the late '70s and into the early '80s, the percentage of meat and bone meal produced using solvent extraction in the UK had declined pretty rapidly. It was thought that perhaps this had some association with BSE emerging in the mid-1980s, bearing in mind the five year average incubation period. The hypothesis was that since solvent extraction involves exposure to hot solvent, then dry heat and moist heat to drive off the residual solvent -- these processes added to the rendering process that had already gone on beforehand may have collectively provided sufficient inactivation of these agents to at least keep them below the levels that would represent a meaningful challenge for cattle. Within the context of the rendering study that is -- we had only a rather limited capacity to do so with extraction studies out there in the field. But on the one occasion when we did, we saw an extraction as putting greaves through hot solvents. You drain off the fat laden solvent and then the solids are treated with dry heat and usually wet heat, and then pulverized to produce meat and bone meal.

In the one instance where we were able to do field studies in the natural solvent extraction plant, although the input level of scrapie infectivity here was rather low, the same level was detected, surprisingly, after exposure to hot heptane and then exposing the solid materials to dry heat at 100 degrees Centigrade and steam at 100 degrees Centigrade. However, recognizing that we were going to only have the limited capacity to look at solvent extraction in an actual commercial plant, we designed some simple lab studies to try and tell us a bit more about solvent extraction.

We knew from discussions with the renderers that these are the sorts of solvents that had been used in the UK. The last two surviving solvent plants in the UK used hexane and heptane respectively. It is those shown in yellow which we actually tested. The methodology was really high tech as you can see, test tubes -- we used bits of infected mouse spleen. This was mouse spleen infected with either the 22 A strain of scrapie agent, or the 301 V strain of BSE agent, added appropriate volume of solvent, heated to the appropriate temperature, and then followed up with the draining of the solvent and heating the solid materials with dry heat and wet heat.

Now, we recognized that one criticism that might be made of this study is that it in no way mimicking commercial solvent extraction because during commercial solvent extraction, it would be customary to percolate solvent through the raw materials, drain this off, distill it, to remove the tallow, and then recirculate that solvent. So, if infectivity was being removed in the tallow in the commercial process, we wouldn't be mimicking this here. However, two comments.

One is that the fat content of spleen is way below the three percent level of fat that would customarily be in the meat and bone meal produced by solvent extraction. Furthermore, as I said, although limited, we did do some studies on tallow and the rendering experiments. Protocol I in both the BSE and the scrapie run happens to represent the protocols which were the least inactivating. In this case, in the BSE run, we got almost as much infectivity in meat and bone meal as we could in the beginning. And yet, under these conditions, we found nothing in the tallow.

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