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

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There's one other process. It's a waste heat dewatering system and it's really a combination of the continuous cooker with an evaporator. The way that this system works is raw material is ground and subjected to a pre-heater at about 180 degrees. The material then goes through a twin screw press where a lot of the liquid is removed from the raw material. The press cake or the solid goes directly to the cooker, and the liquid goes to an evaporator that's using waste heat from the cooker to do some primary evaporation of moisture. The concentrated liquid is also then mixed with the press cake and goes to the cooker where it's processed. Temperatures are the same as the continuous cooker, roughly 240 to 270, and retention time in this system is about 20 minutes. But there's also some retention time of the tallow in the evaporator. This is also under a vacuum, so the temperatures in here are reaching over boiling, probably 220 to 230. After the material is processed, the free fat goes to the work tank and the slurry goes to the press. Again, where the fat goes to the work tank and the press cake is ground for meat and bone meal. The tallow that's produced here is centrifuged and filtered also and is then ready for sale on the open market.

So, in summary, we've seen the different processes, the different raw materials that make up the renderers' trade. This slide really shows the different finished products that are produced from the process. The dewatering, cooking and processing produce bleachable tallow. About 30½ percent of the raw material ends up as bleachable tallow. Special and choice white grease is about 2½ percent. Yellow grease and poultry fat is about 19 percent; meat and bone meal about 34½, brown grease one percent, blood meal one percent, feather meal 3½, poultry meal 4.7. Then hides are about three percent of the raw materials. They are not processed through the rendering process, but that's one of the finished products that some renderers also handle.

The largest volume of product manufactured in a rendering process is waste water. It's about 52 percent of the raw material. So, only about 48 percent end up as the meal and the protein. That's usually about 20 percent tallow and 25 to 28 percent protein is an average production out of the total.

Next, I'd like to take a couple of minutes just to talk about the concept of HACCP as it applies to our industry.

CHAIRMAN BROWN: Mike, could I interpret you just a second? What happens to the waste water?

MR. LANGENHORST: The waste water?


MR. LANGENHORST: It depends on the process and the system. Many plants have primary treatment in the plant where there are one or two systems that the waste water would go through. There's a mechanical separation: dissolved air floatation systems or flocculants that are added and a large percentage of the product is recovered before the flocculants are added. They can be processed into lower grade tallows or greases. The solids also could be recovered in the first stage at that point. After flocculation and processing, the waste water either goes to the municipal sewer treatment plant at that point.

Or a lot of us also have secondary treatment right at our facility, whether that be a biological system, aerobic or anaerobic. From there, it is sent to the local municipality. Or third, other facilities have waste water treatment lagoons and do a land spreading of that product. So, those are probably the three different options that happen.

Next, I'd like to take a few minutes to talk about the concept of HACCP as it applies to our industry. Although this magazine cover represents the implementation of HACCP for the meat industry, it could very well be on Render Magazine in the near future. About four years ago, Dr. Franco put together a guideline for the industry to use for the implementation of HACCP. In 1995 our company, as well as many others in our industry, went through the process of developing and implementing our own HACCP program. We are still not required to do this, but I would say roughly 70 to 80 renderers in the United States out of the 292, have already started working under HACCP programs or implemented them. So, I think it's something that our industry is definitely aware of and is in favor of working.

I've taken a few excerpts from our HACCP program and I'd like to just outline these a little bit and give you a brief overview of the program that we did adopt ourselves. Traditional quality assurance programs at our company, as well as most renderers, were generally based on what management believed to be a good program. But at times it lacked uniformity as to what constitutes an effective program. Also, many of these programs were measurements of end product quality rather than proactive preventative systems of process control. HACCP introduces the principle of a preventative system of quality control. It outlines measures for extensive evaluations and control over raw materials, process, environment, personnel, storage, distribution, monitoring and traceability. So, it's really from start to finish that we're involved. The concept is simple, logical and a highly specialized system of controls to prevent the occurrence of hazardous or critical situations during the process of rendering.

Additionally, the HACCP program has -- inventory officials that we assume responsibility to develop a voluntary program to ensure regulatory compliance. To be effective, the HACCP program requires a commitment from our entire work force to work as a team to achieve the goals of planned prevention.

What I've done here is just outlined very briefly the critical control points that we identified in the rendering process. There are really three different areas. One is raw material, one of the critical control points. We have a multiple death policy, sheep or goat policy and CNS suspect cattle and foreign material. We do have letters and documents that go to all of our raw material suppliers. We go through our process and our qualifications with them. They all understand our requirements and sign sheets individually. We've also trained our drivers and our people in the plant to look for different things in the raw material.

The second critical control point is really the process itself. That's residence time and temperature. We monitor that daily, hourly, by the minute and make sure that we are abiding by the time and temperature requirements that we've set up. On the meat and bone meal protein side, we have one critical control point and that's salmonella sampling program. The rendering industry, I believe 97 or 98 percent, belong to the API salmonella program. A very high percentage of compliance with that and that is a critical control point that the majority of the rendering industry is doing at this point in time.

On the tallow side, one critical control point is the pesticide check. As I said, that's not really a quality term that's used as a finished product quality of the tallow, however, it's very important that we check every batch or production for pesticides. If there would be any, it would show up in the fat and we would also be able to find it then in the other products that would be there. But before we ship any product, pesticides are checked.

Management must reassess TASA plans at least once a year or whenever one of the following occurs. Potential new hazards are identified. New ingredients could be added to your products. Processing steps or procedures are changed or new or different equipment are added to the manufacturing process. As I stated earlier, this is one of the letters that we use with our raw material suppliers. You can see, the reason for this letter is to remind our suppliers of rendering raw materials, of our policy of accepting no sheep or goat material or CNS suspect animals from dead stock collectors or slaughtering operations. We have them read this letter and then they also have a sign-off sheet that you comply, as well as with the other areas of the raw materials.

So, in summary, we've covered a lot of information. The history of the rendering industry, we went through a little bit of a rendering school. And we've also discussed TASA. Our industry does provide many major services. We provide safe feed. We provide disease control. We contribute to the environmental health of our planet and we are definitely the original recycler.

Our industry, like many others, is always studying the past and looking to the future. In that light, I'd like to end with these three slides. Yesterday is but a dream and tomorrow is only a vision -- there's no bans, there's no BSE, HACCP is in place, there's no Asian crisis -- but today is a real bitch. So, on that note, I'd like to thank you for your time and your attention. If there's any questions, I'd be happy to address them.

Thank you.


CHAIRMAN BROWN: Thank you very much, Mike, for both an instructive and entertaining presentation.

It is now quarter to 10:00 and I think we can entertain, in fact, questions from the Committee members to Mike at this point.


MR. FAITEK: Do you, as a matter of routine, exclude CNS materials from your raw materials?

MR. LANGENHORST: Yes. You saw that is our policy. We exclude CNS suspects as well as sheep and goats.

MR. FAITEK: All CNS material?

MR. LANGENHORST: Yes. CNS suspect, yes.

MR. FAITEK: How about unsuspected?

MR. LANGENHORST: Could you define what you're saying?

MR. FAITEK: Do you use any CNS materials in your raw materials at all, brain, heads, spinal cord?

MR. LANGENHORST: Oh, sure, sure.

MR. FAITEK: You do?



DR. ROOS: You mentioned that there were 220 or so renderers and it wasn't clear to me, in a way, who you're speaking for. And whether, you know, there may be a small renderer in one state or another or maybe many which, in fact, might use CNS material or have a purification system that's different from the one that you're speaking about here?

MR. LANGENHORST: I'm speaking on behalf of the National Renderers Association and API, probably representing the industry. The processes that I showed you are the processes that are used in our industry. There are no other processes that I'm aware of except maybe slight derivations from these generic slides that I showed. All renderers process -- you keep going back to the term "CNS."

There's no BSE in the United States and all renderers process all raw materials. The ban that was implemented this past year precluding the feeding of any of the ruminant material to ruminants or any of the mammalian material to ruminants has eliminated or put up the so-called fire wall of any concern of cross contamination being fed back into the food chain. So, all renderers process the heads, spinal columns, or whatever materials there might be.

DR. ROOS: And all renderers are members of your group of Renderers Association, is that --

MR. LANGENHORST: Not all, not all.



DR. ROOS: So, there may be someone who has practices different from what you're describing here? Is that --

MR. LANGENHORST: No, I wouldn't say that.

DR. ROOS: Paul, are we going to hear from European renderers as well? In other words --

MR. LANGENHORST: Are you getting at a specific question? Are you talking about the rendering systems in the EU -- in Europe versus the United States?

DR. ROOS: That was one of the questions I raised. I didn't know whether we were going to hear with respect to the European renderers, just in the sense that we're going to be talking about tallow and safety of tallow and purification of tallow?

CHAIRMAN BROWN: Well, we have two speakers who probably know more than I would imagine on even the details of European, or at least United Kingdom rendering and they are Ray Bradley and David Taylor. Maybe we'll wait until we hear what they have to say and then if you still have questions, we can address them.

I have a couple of questions. For those who haven't done the arithmetic, 240 degrees Fahrenheit is the same as 115 degrees Centigrade and 270 degrees Fahrenheit is the same is 130 degrees Centigrade. Those of you who operate with titres are more interested in the Fahrenheit. Those of us who operate with titres are more interested in the Centigrade. Most of the work which has been done by us titre folks has been done at temperatures of about 121 or 132, 133, 134 and so forth. How much of a bother would it be to up the anti on the achieved temperatures in the rendering process from 240 to 270, say, to 270 to 300?

In other words, can you increment the operating temperature in the steam extractors, these cooking ovens, without undue sacrifice?

MR. LANGENHORST: There would be dramatic degradation to the finished product.


MR. LANGENHORST: You would burn the tallow and the protein would be degraded.

CHAIRMAN BROWN: What's the maximum temperature that you can achieve and still have usable tallow?

MR. LANGENHORST: It depends on the raw material, and that's why I said there are ranges from 240 to 270.

CHAIRMAN BROWN: Yes, 270 would be about as high as you would want to go?

MR. LANGENHORST: Probably as high, yes.

CHAIRMAN BROWN: Is there any reason why the FDA hasn't included grease in this consideration, or is this understood when we're talking tallow we're also talking low titre grease? Is that right? Grease is up for grabs as well? Okay.

Other questions? Leon?

MR. FAITEK: What percentage of your product is imported? What percentage of your raw materials?


MR. FAITEK: From out of the country.

MR. LANGENHORST: There might be a little bit from Canada that the packing houses would use as raw material, but we're going to be talking about finished product importation in the next speaker.

MR. FAITEK: But all of your raw materials come from domestic sources?

MR. LANGENHORST: We collect them from domestic sources, yes.

CHAIRMAN BROWN: Yes, go ahead.

DR. HUESTON: Mike, can you clarify? You talked about this edible rendering system and just for my curiosity --

MR. LANGENHORST: Okay, well --

DR. HUESTON: -- so that crude fats coming into the surge tank and there's a disintegrator step, is there heat associated with either the surge tank or the disintegrator?

MR. LANGENHORST: There is heat in the first part. After the raw material is ground, it goes into the melt tank and that's at about 120 degrees Fahrenheit.

DR. HUESTON: 120 degrees Fahrenheit.

MR. LANGENHORST: So that it liquifies the product to a degree and then it goes through the disintegrator where it's further ground for the separation step. The reason it stays at 120 or less is because the tissue that comes out is considered edible tissue. So, they don't want the temperature above the 120. The fat after it comes out past that point then goes through the other process of further steam injection and centrifuging. That's where the tallow itself is heated up to about 220 or 225.

DR. HUESTON: Great, thank you.


Oh, yes, Barbara?

MS. HARRELL: I'd like to know how long has the process that you described been utilized? Number two, are these processes utilized to reduce infectivity or to ensure that you capture all of the tallow and that it is of high quality?

MR. LANGENHORST: First question was how long these processes have been used? Batch cooking has been around for 60 years probably.

MS. HARRELL: The entire process. The entire process that you talked about, the screening, the -- I mean, the entire process that you described, not just one part of it.

MR. LANGENHORST: There were different cooking processes that came about at different times. The batch cooking process has been around roughly since 60 years ago. The centrifuging and filtering probably started 30 to 35 years ago. As I said in my discussion, the continuous processes started in the '60s also.

MS. HARRELL: So, this was not in response to BSE or anything, or TSE --

MR. LANGENHORST: No, this was not in response to the outbreak.

MS. HARRELL: Just trying to increase the capture of the tallow and the quality of it?

MR. LANGENHORST: Yes, improved quality and improved efficiencies.


DR. LURIE: Could I just ask one follow-up question?


DR. LURIE: Just to follow up on the question about the importation of raw material, you told us about sort of yesterday, today and tomorrow. Where do you see the future trend in this? Is there really enough raw material around for you to satisfy your needs, or do you anticipate in the future, the need for more importation of raw material?

MR. LANGENHORST: The question has to do with raw material sourcing. The total amount of raw material will decrease a little bit, but as population increases, people are going to continue to eat. What the trend shows is that the independent renderer produces less and there's less raw material for him, but there's more for the packer renderer.

What will happen is, there will be continued consolidation of the independent renderer and those numbers will decline in the future. You can only reach out roughly 150 to 200 miles for raw materials because of the concern of degradation to the raw materials. So, as far as importing raw material, that's not an option. You have to be located in proximity to where the materials are sourced in order to have a viable operation.

CHAIRMAN BROWN: Mike, you seem to be the right person to ask this. If you're not, maybe you could hoist it on somebody else. We read that the BSE epidemic probably, almost certainly, originated as a result of changed rendering processes in the United Kingdom that occurred around the late 1970s and involved, among others -- perhaps crucially -- the dropping from rendering plant processes of a hydrocarbon solvent step.

Was that step ever used in rendering in this country? If so, was it stopped at about the same period?

MR. LANGENHORST: Hydrocarbon extraction was used back in the '40s and '50s. Maybe some plants into the early '60s, but has not been a part of our industry for probably 40 years. And while it was not a common practice in the industry, it was used by a few people to get a higher percentage of tallow out of the protein. It was stopped for a couple of reasons. One, it was a major safety concern. Then also, the advent of new pressing systems precluded the reason to continue using solvent extraction.

The hypothesis of change in rendering systems between the UK and the United States, there's a lot of different facets. It's not just difference of solvent extraction. Raw material composition was a major component of that. You look at the population of sheep versus cattle --

CHAIRMAN BROWN: No, no, we're aware of the different features.

MR. LANGENHORST: -- you know, you can go through all those different things.

CHAIRMAN BROWN: But the specific feature I asked about was the one you answered.



DR. OLANDER: A question about headless animals. No headless animals are going into the system for inedible?

MR. LANGENHORST: That's our company's policy.

DR. OLANDER: Your company's policy.

MR. LANGENHORST: I don't know how the total industry is handling it. You can ask Mitch --

MR. KILANOWSKI: We've got the same policy.

MR. LANGENHORST: And a lot of the companies do. So, I don't want to represent the total industry on that, but a lot of companies are taking that approach.


DR. ROOS: I just wanted to make certain I understood these purification systems. You described a number of them with respect to inedible fat processing and you have 220 renderers. Is there one system that's primarily used at the moment or did they all kind of use different variations? Maybe I'm wrong and -- my comments, getting back to the temperature issue here. If that's going to be an important one with respect to inactivation of the BSE agent, what does best with respect to temperature here? That is, the highest temperature for the longest time with respect to the purification scheme.

MR. LANGENHORST: The first answer would be that there is a combination of all of these different systems used. There's nothing that's predominant in the industry. They'll accomplish the same thing with different reasons for running different systems.

The second part of it is, we don't have BSE in the United States. And as far as anyone that's done work with that, I think Dr. Taylor is going to go through a lot of discussion as to where they found inactivation with different rendering processes.

DR. ROOS: My question was which one of these systems would have the highest temperatures for the longest time?

MR. LANGENHORST: Probably the batch cooking system.

CHAIRMAN BROWN: If there are no further questions, we will take a break. It's exactly 10:00, and we will reconvene at 10:15.

Thank you.

(Whereupon, off the record at 9:55 a.m., until 10:14 a.m.)

CHAIRMAN BROWN: Would the various Committee members who are not seated please take their seats around the table so that we can begin the pre-prandial session?

What will happen now is that we will hear from Mitch Kilanowski, David Taylor, and Raymond Bradley. Because tallow and tallow derivatives have been presented to us as subsets of the topic, the appropriate breaking point would be after Dr. Bradley. That would bring us to an earlier lunch than was planned and I think I will plan on doing that. We will have the three stipulated presentations and then break for lunch which is likely to be closer to noon than to 1:00. We will then continue on a little ahead of schedule.

The only other point is that in view of our European representatives being, at the moment, on the sidelines after their presentations -- that is to say, the presentations of Drs. Taylor and Bradley -- we will invite them to take a seat around the table to facilitate the discussion which may involve them heavily.

Now the presentation about market dynamics data from Mitch Kilanowski.

MR. KILANOWSKI: Thank you, Dr. Brown. Thanks for pronouncing my name right because usually it gets slaughtered more than the cattle that we're talking about.

First of all, happy tax day. I guess that's an oxymoron. Thank you for inviting us to make this presentation. My name is Mitch Kilanowski with Darling International, and I'm going to speak to you about edible and inedible tallow production in markets on behalf of the National Renderers Association. We do have some redundancy here, so I will not mention some things.

Edible tallow in the US production and uses. First of all, let me clarify something about edible tallow. Edible tallow when produced does not contain heads or spinal cords. That goes to the inedible part. Our production is approximately 1.45 billion pounds per year. Consumption and edible products, which is baking and frying fats, is approximately 350 million pounds per year. Consumption in edible products which would also be other disappearance is approximately 800 million pounds. Much of that goes for soap, pet food and fatty acids. Exports of approximately 250 million pounds per year, but actually, I think that figure is much larger than that mainly because it gets exported out as tap white tallow mainly for soap manufacturing. Ending stocks are about 15 million pounds per year.

Edible tallow specification, as Mike went over, titre or titre -- whichever one we want to say -- is 41 degrees Celsius, minimum. Free fatty acid of 0.75 percent. FAC color which measures the color of the fat was a three max, which would be basically a pure white tallow. Moisture, 0.20 percent and impurities of 0.05 percent. Anything out of those specifications if shipped as edible tallow and it gets there and it's not in that specification, is rejected.

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