TR Transcript of meeting Vol 11/26

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 PANEL MEMBERS: Dr. Murray Lumpkin (Presiding Officer) Dr. Kathleen Akin, Dr. Delia Parham, Dr. Stephen Sundlof, Dr. Stephen Solomon, Dr. Dan Machesney TRANSCRIPT OF PROCEEDINGS OF PUBLIC HEARING The Public Hearing concerning Substances Prohibited From Use in Animal Food or Feed and Animal Proteins Prohibited in Ruminant Feed commenced at 9:00 a.m. on the 30th day of October, 2001, at the Century Ballroom, Westin Crown Center Hotel, One Pershing Road, Kansas City, Missouri. Substances Prohibited From Use in Animal Food or Feed Animal Proteins Prohibited in Ruminant Feed FOOD AND DRUG ADMINISTRATION PUBLIC HEARING 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Dr. Michael K. Hansen Mr. David Miller Dr. J. P. Fontenot Mr. James H. Hodges Mr. Michael Langenhorst Dr. Don A. Franco Mr. Robert A. Frish Mr. Kevin Custer Mr. Dennis Griffin Mr. David Kaluzney Mr. Gerald F. Smith Dr. Gary G. Pearl Mr. Richard Sellers Mr. Joseph M. Garber Mr. Brad Gottula Mr. Ben Jones Mr. Randall C. Gordon Mr. Mark L. Hohnbaum Mr. Michael F. Malecha Mr. Steven Roach Mr. Chuck Massengill INDEX OF SPEAKERS Page 14 27 37 46 52 59 65 83 85 88 96 102 108 119 128, 154 133 149 165 169 176 189 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 up. DR. LUMPKIN: I would like to call this Part 15 hearing to order, if I could. Everyone who wishes to be part of the audience, please be in their places. I am Murray Lumpkin. I'm the acting deputy commissioner of the FDA, and I will be the presiding officer at this particular public hearing. I would first like to thank each and every one of you for taking time out of your schedules to be with us today to have this opportunity for us and our colleagues from the Department of Agriculture to hear your comments, to hear your concerns, to hear your thoughts on this issue that is obviously of extreme importance to all of us. I'd also like to take a moment and especially thank three people who really did all of the hard work for getting this particular meeting set up. Those people are Tywanna Paul from the FDA Kansas City district office, who really, as far as I understand, did all the logistical work. And Tywanna, could you stand 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 We appreciate it. This is the person, if you have any questions about logistics or about what's happening here today, please feel free to ask her, because she's the one who has all the logistical answers. Thank you very much, Tywanna. I'd also like to thank Bill Sedgwick, who's the deputy district director here in Kansas City, and all of his staff, whom you met outside, who were working so hard to get you checked in and try to meet your various needs while you're here. I'd also like to thank Linda Grassie from the Center for Veterinary Medicine from Washington. She has been the person from CVM who's been working with our Kansas City colleagues to get this particular meeting organized and get all the logistical work done. So all the praise for this particular meeting in this room and everything that went into it clearly goes to those three individuals. you. For those ever you who might And a special thank you to all of 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 not have ever been to or taken part in what we call a Part 15 hearing, let me take just a couple of minutes to try to review for you what the purpose of this meeting is and how these hearings are conducted. These are general public hearings that the FDA conducts under our regulations. They are simply to provide a forum that, when there are issues that are of extreme importance to the FDA, when we are beginning to look at how we do certain things in our business, when we're beginning to look at our rules and regulations, when people are raising issues about the adequacy of rules, regulations, procedures, it gives us an opportunity to put that information out and to tell the public that these are the kinds of things we're hearing, these are the kinds of things that we have questions about and concerns about, and, before we get into any kind of formal rule-making, to hear from the public what they think about these issues and where they think we need to go -- or perhaps don't need to go -- on a given issue. And that's really what the purpose of this meeting here today is. 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 As we said in the Federal Register that went out announcing this meeting, there were a whole host of issues relative to our present feed-back rule that we have some questions about. I think as all of you are aware, this particular rule was promulgated back in 1997. We've had a four-year, four-and-a- half-year experience with it now, and in that period of time much new has been learned about BSE and CJD and variant CJD. We've seen BSE spread now into continental Europe, we've seen it spread into Japan, and because of these things I think we felt like it was an appropriate time to look back and to ask ourselves whether our present feed rule is, indeed, adequate. could be yes. The answer It could be that it's perfectly adequate, that it does what it's intended to do, and that no changes in it are needed. It could be that, indeed, it needs to be tweaked, that there are things that we've learned, there are things that we haven't done as well as a larger community as we thought we could when that rule was promulgated, and so we need to know that. As all of you know, the process 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 for looking at that rule begins with this Part 15 hearing. We'll get a lot of different That's the viewpoints today, and that's okay. purpose of this. If the decision is that, indeed, perhaps some changes in the rule are necessary, we would go forward with a proposed -- with what's called a Notice of Proposed Rule-Making where any changes in the rule would be specifically outlined and any new wording for a revised rule would be printed for public comment. After that public comment came in, then the process is such that we would go forward with issuing a final rule that would, indeed, promulgate any changes, if, indeed, any changes were needed as we go along. So this is not the end of a process today; this is clearly just the beginning of a longer process if, as I said, the consensus or the idea at the end of the day is that our present rule needs to be tweaked to meet the new knowledge and the new contingencies that we have. In a Part 15 hearing, as I said, the purpose of a Part 15 hearing is for us 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 up here on the panel, representing different parts of the federal government, to listen to what you all have to say. This is not a forum for us to announce new policies, to say this is where we think we're going or where we don't think we're going. This is really a chance for you to tell us what you think we need to be doing relative to the issues that are germane to the topic today. One of the rules of Part 15 hearings is that when your colleagues get up to speak, you cannot cross-examine them. This not a time to have he said/she said/they said and have it go back and forth in the audience. And I think in the many Part 15 hearings that I've been part of, people have been very respectful of that. They've noted that there are people And, indeed, this who have different opinions. is one of the glories of our system, that we have an opportunity to come forward and give those opinions, knowing that everyone who gives their opinion will be shown the respect they deserve. And I will assure you that will be the way this particular hearing is conducted. After a person speaks and gives 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 his or her opinion, people in the panel here are free to ask clarifying questions to follow up, that kind of thing. But I am going to try to do As you can the best I can to keep us on time. tell from the agenda, we have a fairly full agenda. People have been limited to a maximum As you get close to that of fifteen minutes. fifteen minutes, I will -- we don't have any red lights or anything like that, but once your fifteen minutes is up, I will interrupt people and ask them at that time to start to bring their presentation to a close. I hope all of you will be respectful of each other. I hate for us to go over early in the morning such that people who are scheduled later in the afternoon feel rushed or feel like they're not going to have the time that they deserve to have. By law one of the things that we have to do with these hearings is to provide at least an hour where people who have not registered to talk have the opportunity to talk. In the Federal Register we announced that that hour would be the hour between 4:00 and 5:00. So we will be in session at least until 4:00 in 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 case someone read that the public session for people who were not registered begins at 4:00 and shows up at that time. If, indeed, we have no one at 4:00 who wishes to speak as an unregistered speaker, then I will close the session at that point in time. But we will be in session until 4:00 to meet that contingency of our procedure here. Having said that, let me take a few minutes here and just introduce my fellow panel members. I think most of you probably know these individuals, but for those of you who don't, starting on my far right here is Dr. Kathleen Akin. She is from the USDA from She is a member of the And she is the area the APHIS part of USDA. TSE working group at USDA. veterinarian in charge at the Lincoln, Nebraska, post of USDA. And she will be the APHIS representative on the panel today. The lady sitting directly to my right is Dr. Delia Parham. She's from the Office of Public Health and Science at the Food Safety Inspection Service in Washington, D.C. So she'll be the FSIS representative here today. And these are my two USDA 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 colleagues who are part of this federal government panel. The gentleman sitting to my He left -- to my far left is Dr. Steve Solomon. is the deputy director of FDA's Office of Regional Operations in Rockville, Maryland. And to my immediate left is Dr. Steve Sundlof, who is the director for FDA Center for Veterinary Medicine. So Dr. Solomon, Dr. Sundlof and I are the HHS/FDA representatives to this panel. There is also a group of individuals who are in the audience with whom we at FDA meet on a quarterly basis. These are representatives from AAFCO, the American Association of Feed Control Officials, and also NASDA, the National Association of State Departments of Agriculture. And we'll be meeting with them tomorrow morning in a closed session, a session between state and federal government officials. And they are here with us today to listen and also to hear what you have to say, because, as you know, they play a crucial role in this particular regulation and enforcement of this regulation. And so I'm going to introduce 11 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the ones that I know who are supposed to be here. If they're here, I'd like to ask them to stand when I call their names so you know who they are, and you can speak to them if you wish. First is Fred Daley, who's the director of the Ohio Department of Agriculture in the far back. Second is Benjamin Jones, Ben Jones, who's with the Texas Feed and Fertilizer Control Services. Ben is over here. Ali Kashani from the State of Washington Department of Agriculture. there's Ali over there. Steve Martin from the Michigan Department of Agriculture. Steve is up here. Ali -- Eric Nelson from the Wisconsin Department of Agriculture, right there. James Watson, who is the State Veterinarian with the Mississippi Department of Agriculture and Commerce. And finally Steven Wong from the California Department of Food and Agriculture. Thank you all. And we also have one 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 international member of our group, Linda Morrison, from the Canadian Feed Inspection Agency. And Linda's back there. So if you all have issues or concerns you would like to express to them relative to their national or state responsibilities, by all means do that. Are there any logistical questions or anything that people have about how we're going to proceed today before we get started? (No response.) DR. LUMPKIN: Okay. According to my watch -- which I did set on Central time this morning -- it is 9:15, and according to our agenda we should be ready for our first spokesperson. So I'd like to call Dr. Michael Hansen, who is a research associate for Consumer's Union. And let me say to Dr. Hansen coming forward, if I misrepresent your title or mispronounce your name, I apologize. At this point, please do correct it for the record. As all of you know, on these hearings we do make a verbatim transcript. Our 13 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 transcriptionist, the court reporter, is up here. Please do speak up and only speak into a microphone so that she can indeed hear what you have to say. Thanks very much. the floor over now to Dr. Hansen. Thank you for being with us. DR. HANSEN: much. Thank you very And I turn I'm glad to be here, and I actually would like to -- Consumers Union would like to thank the FDA for holding this hearing. I also would like to say that we are going to submit written comments to the docket, so I don't have any prepared testimony that I will hand out. But we do think that the FDA needs to dramatically -- well, needs to change the rule and to actually expand it. I am going to go through a little bit of some of the old science and new science which raises concerns for us, and then try to go through a number of these questions and give our responses to them. For some of the old science that I think we have to look at, in our mind, the rule is too restrictive by just dealing with 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 BSE and new variant CJD. We, in fact, think that the agencies here should be concerned with pretty much all forms of TSEs and other forms of CJD besides the new variant. there should be concern over. And here's some of the science behind why we have those concerns. First for some of the old science, there's something called the Gibbs Hypothesis after Clarence Gibbs at NIH. pointed out that probably the TSE that we understand the best is Creutzfeldt-Jakob disease in humans. It's been studies for quite a while, And he All forms of CJD and we know that it occurs supposedly at the rate of one death per million population per year. Now, it's been pointed out in the United States that about fifteen percent of all the cases of Creutzfeldt-Jakob disease are so-called familial cases. And what those are is those are people that have quaint mutations in the prion gene. And as we all know, the prion protein that which is thought responsible for this disease -- that is, the mouth form version of that prion protein -- the normal version is found on the surface of all nerve and many 15 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 lymphocyte cells within all mammals. So we know that in humans if you have a point mutation at a given amino acid on that prion protein, it somehow changes it to make it appear to spontaneously flip over, so that people with those mutant genotypes, they spontaneously come down with CJD and they pass it on to their offspring as though it were a dominant trait. So since that happens with humans, there's no reason to suspect -- since all mammals and all animals have these prion proteins, there's no reason to suspect that similar mutations can't also happen at random. That's why Dr. Gibbs always said that he actually expected that at a very low rate, one in a million, one in two million, one in three million, they would expect to see TSEs in virtually all mammals. And he thought that the reason that that wasn't -- that we don't have evidence of that is because who would notice a slightly ataxic wild animal once it has subtle symptoms? So I think there's -- because of the fact that you can have mutations in the prion gene that we know lead to disease, 16 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 regardless of any kind of outside input in terms of what the organisms, what the humans, are eating, that that suggests that the same thing could happen in other mammals. We should be concerned, for example, in cattle in the U.S., not just about BSE coming from Britain, but there might be a TSE already existing in cattle in this country. In fact if you look, there is indirect evidence of a native TSE in cattle in the U.S. sources: And the evidence comes from two One from the transmissible meat That's TSE that encephalopathy outbreaks. occurs in meat. There's been a number of The first one outbreaks in the United States. which really raised concern of scientists was in -- well, two of them. In 1961, there was an They were outbreak on five farms in Wisconsin. able to -- and they were in adjoining counties. All the farms with affected animals used a ready-mix feed ration which came from the same feed plant, so the scientists assumed that the feed source was the source of this infection agent, but there was many things in this ready-mixed feed, so they couldn't tell. 17 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Two years later, in 1963, there were two more cases of TME outbreaks on mink ranges in Wisconsin. This occurred on two farms And when that were about two counties apart. they went and looked, they found the one surprising thing was that, quote, "Beef carcasses unfit for human consumption" or so-called downer cows, that came from Farm A were fed to minks both on Farm A and Farm B. the scientists noted -- this is Dr. Gary Hartzog, Diedra Berger, they said, quote, "Since mink on both farms developed the disease almost simultaneously, we believe this feed component has to be incriminated." In fact, the following As year, in 1964, at the NIH-sponsored meetings on TSEs and scrapie, Drs. Berger and Hartzog were there hypothesizing that there were sporadic cases of a bovine TSE occurring in the U.S. under the clinical picture of downer cows. We flash forward to the next case that happened in Stetsonville, Wisconsin 22 years later, in 1985. Dr. Richard Marsh In that case, 95 He did a investigated those cases. percent of the diet was downer cows. lot of experiments in the lab and was able to 18 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 show that you could take brains from these animals and just feed them to mink, the mink would come down with the disease. For the people that thought that TME was coming from scrapie, he tried to get scans on every scrapie strain he could find, and he could never transmit it orally to mink. successful with this cattle. So there was the evidence from TME, and then also there's been evidence from the scrapie-infested cattle studies. The first But they were one that took place in Mission, Texas, where they injected scrapie into ten cattle in the '70s, what happened is two to four years later three of the animals died, but they didn't show -- there wasn't classic spongiform damage in the brain. So at the time, some of the scientists said, "No, we don't think this is TSE." Ten years later, in the late '80s, when they finally had the antibodies, they were able to go in, check the brain cells of ten animals, and, sure enough, the three that died, they tested positive. And actually Gibbs was able to take brain material from those animals 19 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and transmit them to mice in the lab, showing that they indeed were TSE. The clinical symptoms were very different than TSE in Britain, and, in fact, since then, there have been further passages of mink from Stetsonville. There have also been passages from Caterburg, Wisconsin, and from North -- Dakota Springs have all been successful. So therefore that suggests that there might be a TSE that's occurring in the U.S. Now, if you look at some of the new science that is out there, that is pretty frightening. In the last four years, NIH, the lab in Montana, has been able to show with studies with scrapie that was done in hamsters, they found that some animals could be silent carriers. They could appear perfectly healthy; that is, you put scrapie into hamsters, they get diseased. You inject the mice with hamster They scrapie, they live perfectly normal lives. are fine. When those mice die, you inject them into other mice, nothing happens; but if you inject them back into hamsters, the hamsters come down with hamster scrapie with a longer incubation period, which suggests that now you 20 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 can have silent carriers. So that means you can have this indirectly; that is, if you feed potentially contaminated, say, meat from a cow that has a TSE, you can legally feed it to pigs, grind up the pigs and feed the pigs back to the cattle. So there's an indirect loop there that raised a lot of concern at the time when these studies came out, particularly in Europe. some new studies that were also done in Hamilton. DCN Petro conversion studies have Also been able to demonstrate that BSE does convert to human prion protein in the lab, and furthermore it converts to prion protein -that's methionated code on 129 -- three times more efficiently than it is failing at 129. know that that fits with what we see because met-met -- if you have -- if you're a met-met homozygote at code on 129 prion protein for humans, you're over-representing -- you have a higher chance of getting so-called sporadic CJD, while recent studies have also demonstrated chronic wasting disease which occurs -- also converts to prion, and it does it at about the same rate that BSE does. Finally, they were able to show We 21 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that scrapie did some converting at its human prion proteins. Now, people would say scrapie There's has been around for hundreds of years. no evidence that it can cause any problems. However, just last year, 2000, Corrine Lasniecess's (phonetics) lab in France, doing some strain type work, which is considered the gold standard -- and that's where you take the TSE posivan and inject it into the brain, certain genotypes of mice and then you look at eight different areas of the brain and do a score for the damage -- they were able to show with the strain typing that they've been able to differentiate many strains of scrapie, and, in fact, this was what the final link that convinced people that new variant CJD was BSE in humans, because when you do the strain typing, the new variant CJD caused one signature, so-called sporadic CJD caused another one; but new variant CJD looked exactly like BSE. When they passed the BSE into mice, into felines or wild ungulus in zoos, the strains all looked identical. So what the French did was they had a bunch of growth hormone cases. They 22 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 decided to use some strain typing and try to figure out maybe where some of those growth hormone cases came from. And what shocked them is one of the French cases, when they strain-typed it, it didn't look at all like variant CJD, but to their amazement, it looked exactly like a French scrapie strain. Now, they looked at a French scrapie strain, sporadic CJD and variant CJD, and what amazed them is now the strain-typing evidence from this one athogenic case where it strain-types out to a French scrapie strain -not a U.S. scrapie strain, but a French strain. This was a French person that died of CJD from growth hormone injections. So that does suggest that strain-typing, that, in fact, that came originally from sheep. And I know scientists in Europe are very concerned about this. There's also been four case-controlled epidemiology studies which have linked sporadic CJD to the consumption of brains and other materials. So because of this, we think the present rule should be expanded; that is, the additional objectives should be that we want 23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to minimize GSEs and new variant CJD. So we think that the present day ban on mammalian proteins in ruminant feed should be broadened and the new parameters should be that all mammalian proteins should be considered -should be banned, and none of those should be permitted to be in the food fed to food animals. So that is all mammalian proteins, with no exceptions, and you broaden it to not just ruminant feeds, but all food animals. That includes fish and fowl now, of course, this fowl protein and fish protein to be able to feed the animals. And as for the exemptions, I'll go through those now. Therefore, we think this exemption of pure porcine and equine protein in your definition of "mammal," that should be revoked; that is, you should not be able to feed the porcine, because the way it stands now, again, there's an indirect route. You can feed material from the cattle to pigs, grind up the pigs and feed it back to the cows. So we think the porcine and pure equine portion should be revoked. is fine. The milk and dairy products, we think, The blood and blood-clotted exemption 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 needs to be revoked because there is a -- we know that the TSE agent can be found in the blood, and we also know that there is increasing use of blood plasma and blood clot instances, that weaning calves, that we don't think that's a good idea. And finally the gelatin should be revoked as well. Now, there's also another provision in that Section 589.2000 that we are concerned with, and that was this provision that says if you had a foolproof test for testing for the presence of TSE -- one doesn't exist yet, but if you have it, if something tested negative, then you would be exempt from their requirements. But if something tested positive, what we do with something that tests positive, and under the present regulation, something that tests positive can go into the animal feed supply, it just needs to be labeled "Do not feed to cattle or other ruminants." We think that that is crazy, and that any TSE-positive animal should not be permitted into any food chain, human or animal. We point out that that was the first recommendation from the WHO expert consultation that was held in 1996 on public 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 health impacts. DR. LUMPKIN: Dr. Hansen, can I Your fifteen ask you to wrap your comments up? minutes are up. DR. HANSEN: Yes. Very quickly, we do think the -- because of problems with cross-contamination that the FDA should require dedicated facilities for the production of animal feeds. transport. And then finally, one more thing. For the recordkeeping requirements, they That's inadequate. They should require dedicated presently stand at one year. We believe it needs to be ten years, because the average incubation period, for example, for BSE is five years. So you need to keep these records so that if something happens you'll be able to potentially trace the feed back to the source. And given that BSE has an incubation period between three and eight years, that there are some forms of scrapie that are even longer, we think we should account for ten years. Finally, for the label requirements, we agree with the FDA that we think that the label should be simplified and 26 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 say, "Not to be fed to cattle or other ruminants," that that should all be spelled out. And again, we'll do very detailed comments to the entire group. Thank you. DR. LUMPKIN: much. The next person who is scheduled to speak is Mr. David Miller, the director of the commodity services at the Iowa Farm Bureau Federation. As he is coming forward, as we pointed out, people are encouraged to submit written comments. The docket will remain open Thank you very for the reception of the comments until November 21st if you wish to get them into the docket. Also, if you happen to have either a written or electronic copy of your presentation, Linda Grassie, who is sitting at the end of the first table here, is collecting those to have them put into the docket. Thank you very much. Mr. Miller, please. MR. MILLER: Thank you. The Iowa Farm Bureau Federation 27 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 appreciates the opportunity to provide oral comments to the Food and Drug Administration in regards to the rules governing animal feed and regulations and the issues that FDA has raised in the Federal Register. Iowa Farm Bureau believes that the current rule is generally sufficient to provide necessary public health protection. We believe that farmers and ranchers are taking the appropriate steps to comply with the ruminant feeding ban. As with any new rule that radically changes production practices and requires significant alterations in recordkeeping and other management practices, complete compliance was not instantaneous with its implementation. We believe that compliance with the ruminant feeding ban is at a high level and increasing. However, it would be appropriate for FDA, in cooperation with state inspection programs, to maintain surveillance of compliance through spot checks and records review of regulated firms. The ruminant feed ban rule was part of a three-pronged approach to reduction of risk as it pertains to introduction and spread 28 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of BSE in the United States food supply. We believe that the rule is adequate to meet its objectives. Government studies have indicated that the risk for introduction and/or spread of BSE through cattle feed is near zero, especially if we can achieve complete compliance. The FDA arguments that were put forth at the time of the adoption of the 1997 final rule were compelling. Those arguments were based on sound science and a review of industry practices. The basic risk factors that the final rule aims to reduce are essentially the same as in 1997, thus the regulations that were deemed to be based on sound knowledge and scientific fact should continue to provide the level of risk reduction being sought. To date, we are not aware of any scientific basis for broadening the ban on the use of specified mammalian proteins in ruminant feeds. In the preamble to the 1997 rule, FDA provided scientific justification for the exemptions offered in the rule. We believe those exemptions are still scientifically justified. The safety of blood products has We been reconfirmed by scientific tests. 29 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 recommend that FDA continue to monitor the science and consider changes when there is compelling scientific justification and evidence. We do believe that the feeding of poultry litter and other recycled poultry waste to cattle could present a means for the spread of BSE, if the disease were ever found in the United States. We recommend that FDA and other appropriate agencies conduct the necessary research to quantify the actual risks associated with feeding of poultry litter and other poultry wastes to cattle. If the risks are as minimal as they appear to be, then no additional action should be taken. If the risks are determined to be significant, then the Iowa Farm Bureau would consider supporting a modification to the prohibited materials list to include poultry litter and other poultry wastes. We believe that "road kill" and all ruminant wildlife should be eliminated from all rendering. Such animals should be buried or incinerated, but should not be allowed to enter the feed supply chain. Domesticated deer, elk and other such animals should be treated as any 30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 other livestock species. Imports of feed and animal protein products should be restricted from those countries with BSE or which are not actively performing surveillance in accordance with the Office of International Epizootics. We support the regionalization of certain areas like the European Union because of the free flow of goods within and among member countries. We are concerned, however, that insufficient attention is being paid to transshipment of animal products from restricted countries or areas through third-party countries. We are also concerned that such products may be mislabeled when being transshipped. We urge the FDA to strengthen the port inspection program and to increase its surveillance of transshipments. We believe that imported feed products pose the greatest threat of introduction of BSE into the United States. We urge FDA to increase its efforts in this area, giving it more attention and funding. We believe FDA should consider making some modifications in labeling requirements. It is becoming standard industry 31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 practice for producers to be required to certify to those purchasing their cattle that they have not been fed proteins derived from either ruminant or mammalian sources. Many producers have indicated that this is difficult if the label does not at least distinguish whether the protein in the feed is derived from ruminant or non-ruminant sources. Currently producers do not have sufficient information to really make this certification. Feeds containing animal proteins often only indicate that the feed contains animal proteins. The producer must assume what type of animal protein from the presence or lack of a warning statement. believe this is insufficient. We Producers should have the necessary information to make the certifications that the marketplace is requiring. Producers in Iowa are concerned that the lack of specific information with respect to the type of mammalian protein sources could lead to producers making inaccurate certifications. We believe broader classifications of protein sources such as "non-ruminant-derived animal proteins" and 32 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ruminant derived animal proteins" may be sufficient, rather than species-specific classifications. We do not believe it is necessary for the label to list specific species that a feed should be fed to. The current label warning is understood by producers. Previously, FDA has indicated that the cautionary statement serves no useful purpose on pet food and feed for non-ruminant laboratory animals and cited this as one of the bases for the current exclusion. Iowa Farm Bureau is unaware of any changes in industry practices or risks to food safety that have been introduced because of this exclusion. We see no need to remove the exemption and believe that FDA's justifications of this labeling exemption remain valid. We believe that the imposition of a requirement that dedicated facilities be used for the production of animal feed containing mammalian protein would provide little, if any, reduction in risk, given the extremely small number of commingling incidents and the very low level of commingling. Similarly, we believe that 33 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 imposition of a requirement that dedicated facilities be used for the transportation and delivery of animal feed containing mammalian protein would provide little reduction in risk given the extremely small number of commingling incidents and the very low level of commingling. Such a requirement, however, would impose significant costs on the industry and would reduce the number of feed manufacturers, thus needlessly raising costs to producers. We believe it would be very counterproductive to initiate rules that could be construed to prevent carrying a bag of dog food on the deck of a feed truck hauling cattle feed to a farm. We believe the current authorities, penalties and other compliance mechanisms available to state and federal authorities are sufficiently adequate and severe. No new penalties are necessary. If additional resources are avilable to FDA for compliance work, such resources should be directed at inspection of facilities using restricted-use protein products and for improvement of overall surveillance. Imposition of additional regulatory burden and paperwork on 34 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the feed industry to implement a licensing program would not be a wise use of agency funds. We believe the federal commitment to a full and ongoing inspection program is vital to the success of the ruminant feed ban as a risk mitigation tool in the fight to keep the United States free of BSE. We believe that we must have 100 percent compliance and 100 percent inspections. This will require state and federal agency cooperation as well as industry action. We urge FDA to do a review of the third-party certification programs that have been developed by the industry. If, upon review, these third-party certification programs are deemed reliable and responsible, then we would urge FDA to officially recognize and cooperate with such programs. In summary, we believe the current rule governing the use of animal proteins in ruminant feeds is, in general, working well. Areas that might be considered for modification to further reduce any potential risks are restrictions on feeding of poultry litter to ruminants and more extensive monitoring of imported ruminant feeds. We urge 35 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 strong enforcement of current regulations, but do not believe that additional regulations are necessary to increase compliance. We believe a federal commitment to a full and ongoing inspection program supplemented with industry certification programs are essential elements of this effort to reduce the potential for introduction of BSE and minimize the potential for spread of the disease vector should it ever occur in the United States. We appreciate the opportunity to provide these comments regarding the prohibition of specified proteins from ruminant feeds. DR. LUMPKIN: Miller, for joining us. Are there any questions of the panel for Mr. Miller? (No response.) DR. LUMPKIN: the panel: And I didn't ask I Thank you, Mr. Any questions of Dr. Hansen? forgot about that. (No response.) DR. LUMPKIN: Okay. Fine. The next speaker is Dr. J.P. 36 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Fontenot, who is the John W. Hancock, Jr. professor of animal science at Virginia Polytechnic Institute and State University. Dr. Fontenot. DR. FONTENOT: much, sir. Thank you very And I appreciate the opportunity to appear here to talk about the feeding of poultry litter. The main reason I requested to appear is that I had heard that there had been some objections raised in terms of feeding poultry litter in relation to BSE. I'll have to crank up the machine here. while. This is what we're talking about. In other words, here's where the poultry We have many of those Just a minute. It takes a little litter is produced. throughout the U.S., especially in poultry-producing states. I'll give an outline of the presentation. I'll talk a little bit about the history of the poultry industry, the class of cattle that are fed poultry litter, quality of animal products, safety of feeding poultry litter, and also look at regulations and 37 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 practical feeding. These are the amounts of waste that are produced per year. You'll notice that somewhat over five million tons of poultry litter are produced per year. In terms of feeding poultry litter, it is fed mainly to beef cows and stocker cattle. to fattening cattle. Little, if any, is fed Substantial amounts are In Virginia it fed in broiler producing states. is estimated that 20 to 25 percent of the litter that is produced is fed, which would amount to somewhat over 100,000 tons. In the U.S. about 5.6 million tons of broiler litter are produced. It would amount to -- if we say twenty percent is fed, that would amount to about one billion tons per year. So it is a substantial amount. Description of the poultry litter. Poultry litter is an accumulation of excreta, some wasted feed, feathers and bedding material. Bedding material is usually wood shavings, sawdust, peanut hulls or other fibrous materials. Options for utilizing animal wastes. It's been applied to the soil for It can be used also as a substrate centuries. 38 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 for methane generation from microbial and insect protein hydrant. The most economically feasible is one of feeding farm animals. Nutritional value of poultry litter. It is quite nutritious. It has 25 to 30 percent protein on a dry matter basis, fifty-five to sixty percent TDN. minerals. It is rich in If you want to compare it to, say, feeds -- feedstuffs, it would be at least equivalent to good quality alfalfa hay or higher; in other words, it's higher in protein, it's higher in energy and it's higher in some of the minerals, and the performance of animals fed poultry litter has been equal to animals fed traditional feeds if the nutrients were equalized. About the quality of animal products from animals fed poultry litter. has been very extensive research. There There have been no differences, no deleterious effects on the carcass quality. Furthermore, in cooking and taste tests with animals fed poultry litter, there has been no harmful affect on feeding the litter on the taste of the meat. Let's look at the safety, then, 39 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of feeding poultry litter, which is one of the things that we need to be concerned with. young lady here is cooking steaks for her family, wants to make sure that it is safe. The history of the poultry litter feeding -- this is a little bit out of order. Poultry litter has been fed to beef The research on We This cattle for at least 40 years. feeding poultry litter started in the 1950s. started doing our work in 1963. In residues -- this is the slide I was getting to -- there have been no accumulation of pesticide residues after a one-day withdrawal, we found that there was no accumulation of heavy metals, and after a five-day withdrawal, although there were medicinal drugs in the litter, there were no medicinal drugs found in the meat or the litter. So the meat has been found to be safe. In terms of were pathogenic organisms, there are potential pathogens. The litter should be processed; however, there is no information concerning BSE on poultry litter. Processes that are effective to process poultry litter: Dehydration, ensiling 40 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and deep-stacking. I think you are all familiar Deep-stacking with ensiling and dehydration. would look something like on the next slide. This is a large structure, and many of those in the poultry-producing units such as Virginia, where we have deep-stacking of litter, it's stacked several feet high. undergoes the heat and does destroy the pathogens. Although poultry litter is a potential source of pathogens, in a recent Georgia report, they found no salmonella. E.coli was isolated from 86 samples. Some of It that had been processed and had not been processed. However the litter should be processed to destroy any potential pathogens. Clostridia problem, I would like to address. In some countries there have been outbreaks of botulism occurring in cattle fed poultry litter. In all cases this was due from Clostridium botulinum arising from poultry carcasses in the litter. cases reported in the U.S. There have been no I have followed the cases very carefully in all other countries -I'm not going to name them -- but there's none 41 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in the U.S. However, it is important to remove the carcasses from the poultry house. In terms of animal health in the U.S., we have observed copper toxicity in sheep and poultry litter. This is not a serious problem in cases of cattle because they are not nearly as sensitive as sheep to copper. As a matter of fact, over a seventy-year period we fed high-copper poultry litter to beef females every winter for seven years, and we observed no symptoms of copper toxicity. The liver copper levels were up in the spring, but then after they went to pasture the next fall, they were back down. Okay. In terms of regulation, most states follow the Association of Feed Control Officials in terms of their model regulation, which means the waste must be free of pathogens. If the waste does not contain drug residues, no withdrawal period is required and can be fed to any class of animal. If the waste does contain objectionable residue, a fifteen-day withdrawal is required. Feeding poultry litter and BSE. This question was addressed by FDA in 1998. The 42 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 code is given here. raised was: The question that was Can chicken litter be fed to cattle if poultry might have been fed prohibited material? And the FDA's answer is yes. The FDA has no evidence that the agent that causes BSE would survive the chicken intestinal tract. FDA expects the states to require recycled animal waste to conform to the definitions promulgated by AAFCO's publication, which is described in the model regulation. Practical feeding. As I said earlier it is fed primarily to beef cows and stocker cattle and is usually mixed with corn or other palatable materials. or straw is usually fed. The value of poultry litter, about a hundred dollars a ton, based on its nutritional value as a replacement for hay. many times it is. It's worth about sixty to Soil application, it's And Small amounts of hay eighty dollars per ton. worth about $25 per ton, about four times as much as a feed than a soil application. Okay. One of the advantages in the feeding of poultry litter to beef cattle. For the meat producer it's an economical feed 43 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and it's an alternative feed for such things as during a drought. In some parts of the southeast we are running into a serious drought, and a lot of poultry litter is being fed as a substitute for hay, because hay is becoming short. From the poultry producer, it provides From an environmental excess soil application. standpoint, if we can transport litter further from the production areas because of its value and also keep the high level of nitrogen phosphorous from going to the water supply due to high excess levels of soil application. In summary, then, we feel that poultry litter can be used as a feed stuff if processed properly. It is a safe feed. Performance of cattle fed the waste is similar to that of cattle fed traditional feeds. With good management and appropriate withdrawal, the litter does not result in harmful residues in animal tissue. The higher value of litter as a feed than fertilizer would justify transportation of the waste outside of the areas where it's produced. We feel there is no reason to change the regulation, and we feel that FDA 44 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 should stay with its original statements published in 1998. Again, thank you very much for the opportunity to appear in this hearing. DR. LUMPKIN: Professor Fontenot. Are there any questions of the panel? I have one, just since we've got a little bit of time. You mentioned the Thank you composition of what we generically call poultry litter. One of the things is spilled feed. Do you have any idea quantitatively how much of poultry litter consists of spilled feed? DR. FONTENOT: at all on that. I have no data But my impression is that with the controlled conditions used, you know, by the poultry industry today, we still do that -- we still say that. But the fact of the matter is that when we made this statement, this was more like thirty or forty years ago. I think with the modern technology, it's -- although I have no measurements at all, I think it's very minimal. DR. LUMPKIN: Thank you, sir. 45 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Thanks very much. We appreciate it. The next person on our schedule to speak is James Hodges. He is president of the American Meat Institute and the AMI Foundation in Arlington, Virginia. MR. HODGES: Dr. Lumpkin. Today I am representing the American Meat Institute. We are the nation's Thank you, oldest and largest meat packing and processing industry association. Our members slaughter and process over ninety percent of the nation's beef, pork, lamb, veal and turkey products, and we produce more than sixty percent of the rendered by-products that are manufactured for animal feed in the United States. We appreciate the opportunity to comment on the FDA animal feeding regulations that were put in place to help prevent the establishment and amplification of BSE in the U.S. cattle herd. AMI has and continues to support the scientifically based regulations that restrict the use of animal protein derived from mammalian tissues for use in ruminant feed. 46 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 A careful analysis of the facts suggests no regulatory changes are warranted at this time. I have three messages to leave with you today: First, we do not have BSE in this country; second, we have taken prudent steps to prevent BSE from entering country; and, third, if BSE were to find its way into this country, we can diagnose it, isolate it, and prevent it from reaching consumers in a swift and decisive way. Our risk of BSE from domestic But our cattle is not zero, nor can it ever be. risk today is the lowest it has ever been since the disease was first recognized as a threat to the U.S. cattle population. Any changes contemplated in the regulations must take that into account. Let me focus for a moment on my first message. country. We do not have BSE in this That fact bears repeating because it tends to get lost in the emotional reactions that often surround a public debate on ways to reduce the risk from BSE. Hysterical and speculating news reporting that often accompanies that debate further obscures the 47 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 successful track record that we have established. The BSE crisis in Europe, and now Japan, has provided strong incentives for the U.S. government and the U.S. beef industry to take aggressive actions to prevent this devastating disease. In fact, we took action so early that some people now seem to question why we aren't announcing new major efforts today. The answer? We took swift, science-based actions early on that have protected our livestock and given us the coveted distinction of being a BSE-free nation. The purpose of this hearing is to solicit information and views on FDA's animal feeding regulation. isolation. But that cannot be done in It is important to remember that BSE prevention in the U.S. involves multiple programs that can best be described as a triple firewall strategy. This includes: One, a ban on the importation of cattle and beef products from countries with BSE; two, a statistically sound and comprehensive animal surveillance program to continually monitor for the presence of the disease; and, three, ruminant feeding 48 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 restrictions to prevent the amplification and spread of the infective agent in the unlikely event BSE occurs in our domestic cattle. Taken together, these efforts provide the best reasonable assurance that U.S. cattle will remain BSE-free, and that U.S. consumers will not be exposed to any related health risk. That is not to say we should rest We must continually evaluate on our laurels. and improve our preventative control measures if warranted, and we must assure our regulatory agencies are provided with the necessary resources to do their job. AMI believes the present FDA animal feeding regulations are appropriate, given the low level of risk that BSE will occur in this country. Our goal is not to change the regulation but to achieve 100 percent compliance with the existing regulation. AMI's worked with several trade associations to supplement FDA's compliance activities by establishing a program to certify that animals sold for slaughter have not been fed any feed containing protein derived from mammalian tissues that is prohibited by FDA regulations. The program was implemented 49 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 earlier this year, and our internal surveys indicate that a vast majority of the animals that come to slaughter are marketed under these types of certification programs. A copy of the program details will be provided for the public record. Finally, it is important to remember that BSE has been diagnosed only in Europe and Japan. More than 99 percent of the diagnosed BSE cases have occurred in Great Britain, where the incidence rate has dropped dramatically after animal feeding restrictions were implemented. The U.S. has very different risk factors. Our livestock populations are very different, as are our rendering, feeding and production practices. In addition, these countries are in the midst of a crisis, and crises warranted strong and dramatic actions. In contrast, we do not have a BSE crisis in the U.S. It is critical that our BSE prevention policies reflect that fact and that our policies are supported by the best available science. Again, I appreciate the opportunity to present the views of the American 50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Meat Institute. I'll be happy to answer any questions the panel may have, and I will leave copies of my prepared testimony for anyone in the audience as well as for the public record. DR. LUMPKIN: Mr. Hodges. Any questions from the panel? DR. SUNDLOF: Jim, you Thank you, mentioned that the significant percentage of the cattle going to slaughter now are covered by the certification programs. statistics on that? MR. HODGES: We don't have firm Do you have any kind of statistics, but if you just survey our major members, all of them are using -- all of them are using some type of certification program -if nothing else, to meet customer needs. So I would stand by my statement that it's the vast majority rather than put a particular number on it at this point. DR. LUMPKIN: questions? (No response.) DR. LUMPKIN: Again, thank you Any other 51 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Mr. Hodges. The next speaker is Michael Langenhorst. He's the past president of the National Renderers Association, Alexandria, Virginia. MR. LANGENHORST: Dr. Lumpkin. Thank you, I'm also the president of the Adamex Group of Companies in Green Bay, Wisconsin. We are a renderer in Wisdonsin, so the first eight minutes of my clock or discussion will be on National Renderers Association and the last two minutes will be on behalf of myself and my company. National Renderers Association is the international trade association for the industry that safely and efficiently recycles animal and poultry by-products into valuable ingredients for the livestock, pet food, chemical and cosmetic industries. The NRA represents 43 member companies operating more than 160 rendering plants. We are very familiar with the issues we're discussing here today. Since the first case of BSE was reported in 1986 and through all the stages of the situation, we've 52 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 been proactive and have worked closely with the FDA and other government departments as well as affiliated industries to produce and promote safe feed. In fact, I believe that the support of the National Renderers Association and our TSE committee has been instrumental in the success of the surveillance program as well as the original rule itself. There are seventeen questions we've been asked to respond to, but I would just like to comment publicly on a few of them. Written comments will be submitted by our industry before November 21st. The main question is: What additional enforcement activities, if any, regarding the present rule are needed to provide adequate public health controls? Are there any suggestions for ways to improve compliance with the rule? The NRA believes that the current rule provides adequate protection for public health and has accomplished its intended goals as laid out in 1997. We realize that there are big concerns expressed with certain aspects of the rule, but feel that these 53 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 concerns can be addressed by providing proper resources for inspections and data management. There have been very few noncompliance events since the rule has been implemented. The majority of noncompliance issues come from incorrect inspection interpretation or incorrect data compilation. In fact, the recent APPI third-party certification program has shown a 98 percent compliance with the rule in the rendering industry. The other two percent have not been determined not compliant, but, rather, have not undergone third-party certification. The NRA strongly supports and would participate in any effort to attain 100 percent compliance of our industry. We would not be opposed to licensing a rendering facility as it relates to compliance with the rule if this would help with enforcement so long as it does not become a bureaucratic nightmare. anyone is not complying with the rule, appropriate action needs to be taken by the agency. Much time and energy went into developing the final rule in 1997. It was felt If 54 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 very strongly at that time that appropriate controls had been implemented to protect public health in the United States. The rule is based on scientific risk assessment and was deemed to satisfy the risk at that time. It must also be remembered that the rule at that time was thought of as a firewall for the meat industry. We all know that the U.S. really has many firewalls in place relative to the BSE: The ban on imports since 1989, the surveillance program which exceeds OIE recommendations, mammalian feed ban of 1997 and now thirty-party certification. We're at the lowest level of risk that we have ever been as a country. There's no need to reopen the rule, but rather we must strive for 100 percent inspection and compliance with the current rule. The NRA strongly supports appropriate restrictions on the importation of feed and animal products. These restrictions should be based on a risk analysis and on a country's BSE incidence. The U.S. could accomplish this by establishing a category classification as practiced in other parts of 55 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the world. The resulting import restrictions and policies would be based on the systemic classification category. Coordination of programs and appropriate financial resources must be put in place to accomplish this initiative. The NRA thanks you for this opportunity to address these issues. We are committed to protecting our public health and continue to be available to work with the FDA. As stated earlier, our common goal is to attain 100 percent compliance. I would also like to present to the panel a third-party report that we have just had done for the rendering industry by the Sparks Company. And this is an economic impact for three scenarios. Scenario 1 is a total animal protein ban -- feed ban to all ruminant animals. The total reduction in revenue to industry -- now, this is not a rendering issue, this is an animal agriculture issue. And I'm standing here as a renderer, but we all have to keep in mind that I'm not here trying to protect the rendering industry. What we're talking 56 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 about here is animal agriculture. The total affect of an animal protein feed ban in all ruminant animals is over $100 million a year. Scenario 2 is a total ban on feeding of ruminant protein to all farm animals, including ruminant meat and bone meal to swine and poultry and ruminant blood meal and plasma to dairy, beef, swine and poultry. The total net reduction to animal agriculture of value would be about $636 million. Scenario 3 is a total animal protein ban for all farmed animals. There's a lot more involved with these things than just a dollar impact, but also the environmental impact. As much as 47 billion pounds of slaughter by-products could accumulate each year, or 64,000 tons each day. That means the rendering is going to continue. The product will probably be rendered and then still have to be dispossessed of. The effect on the economic impact of animal agriculture under that scenario is about 1.519 or 1.52 billion dollars year. So that will also be submitted as part of our report. Let me change my hats very 57 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 quickly now and talk as a director of his own business and his own company to be concerned about. Even though I have been speaking on behalf of the rendering industry, it's not a rendering issue; it's an animal agriculture, public health and a common sense issue. really it's an animal agriculture issue. It must be remembered that meat and bone meal are the not the product of BSE, but rather was involved in the transmission of BSE. The feed ban in '97 eliminated that Meat and bone meal is still a safe But threat. feed. I'd just like to make the comment that animals are not ground up to affect other animals, as we heard earlier. processed under time and temperature requirements and is considered that it is turned to protein meal, much like soybean meal. could be safely fed to other food animals. was safe before '97 and it is safe today. only thing that's changed is that we're no longer feeding mammalian protein to ruminants. This was done as a precaution, not because meat and bone meal was considered a poison, a toxin It It The Material is 58 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 or a carcinogen, even though people treated it as a poison, a toxin or a carcinogen. This needs to be kept in mind as the technology continues to improve. needs to be attention paid to this in the future. Zero tolerance for a safe feed product We've been taught to work from We There is unwarranted. history, and the rendering industry has. will not go down the slippery slope of the Europeans, trying to separate so-called good product from bad product. We are not Europe, We do not have but rather we're North America. BSE. Thank you. DR. LUMPKIN: Mr. Langenhorst. Thank you, Are there questions? (No response.) DR. LUMPKIN: Thank you, sir. The final speaker before our break this morning is Dr. Don Franco. He is president of the Animal Protein Producers Industry from Lakewood, Florida. DR. FRANCO: Mr. Chairman. Thank you, 59 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 The Animal Protein Producers Industry is the association of the United States rendering industry that is responsible for biosecurity, and, as a result, the establishment of programs to ensure feed ingredient safety, including animal proteins that are used as ingredients in livestock, poultry, agriculture and pet foods. In this capacity, the organization has followed the subject of bovine spongiform encephalopathy from the report of the initial outbreak in the United Kingdom in 1986. APPI is conscious of the complexity of the group of diseases collectively defined as the transmissible spongiform encephalopathies and fully recognizes the tentative nature of the science and the fact that BSE is the first disease in the annals of regulatory medicine, animal or human; that a rule was written with all the finite determination and affirmation of the cause of the disease. While this was unusual, APPI recognized at the time that the uncertainty of the circumstances mandated a necessity to establish a series of flexible controls that are in the best long-term 60 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 interests of animal and human health, and as a result, supported the agency in the quest to format a rule that would preclude any likelihood of the transmission or amplification of the infectious agent of BSE and ultimately the protection of the country's public health. About 16 years after the initial report of BSE, we are still discussing the varied nuances of the diseases, including the current questions posed by the agency in their consideration of options, including aspects/concepts for modification, if applicable, of the existing rule. While the complex issues and unanswered concerns of BSE mandate caution, the record clearly indicates that instituted controls in the United States started in 1986, immediately after the confirmatory diagnosis and continuing today in a constant manner by recently promulgated import restrictions are effective. Cumulatively, governmental policies are working and provide ample assurances that adequate constructive measures and controls are in place to ensure the safety of animal protein feed ingredients destined for 61 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the feed food chain. This assurance analogy is best exemplified by the final rule that became effective on June 5, 1997, and commonly referred to as the "animal feeding regulation." This comprehensive rule has addressed the potential hazard/risks associated with the disease and thus establish a visionary protocol to prevent the likely transmission and amplification of this infectious agent. The rule was an excellent proactive response for public health protection at the time it was written. And in the absence of any changes in the risk factors of this country, remains so today. The regulatory agency developed a systematic method for education, inspection, for compliance, and enforcement, and collaborated with the states to assure success of the spirit and intent of the rule. APPI, therefore, as an organization, sees no need for any modification or reopening of the objectives or contents of the rule. Retrospectively, the risk factors in the United States for a BSE incident are actually the lowest since the associated 62 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 links to the outbreak was first described in 1987-88 by epidemiologists in the United Kingdom. This has been affirmed in the peer review professional journals by APHIS, USDA officials, and in the Service's own brochures and publications. The epidemiological case definition for the BSE outbreak in the United Kingdom has been clearly articulated by the following postulates. For an indigenous case of BSE to occur, a simultaneous -- and I say simultaneous -- presence of three factors is required: One, a large sheep population in relation to that of cattle, with a significant level of endemic scrapie; two, conditions of rendering that allow the survival of significant amounts of infectivity and; three, the use of substantial quantities of meat and bone meal from affected sheep or cattle in cattle feed. The addition of a fourth factor applies to countries without the disease and has obvious relevance to the United States. Countries without BSE may also acquire it by the importation of live animals that could be incubating the infectious agent of the disease 63 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 or the importation of contaminated meat and bone meal that could be subsequently fed to susceptible cattle. Fortunately, our established rules in the last fifteen years have addressed the potential risk from a worst-case assessment and thus creating an impenetrable firewall to prevent, again, the likely transmission or amplification of the infectious agent, and, as a result, the protection of animal and human health in the United States. APPI, then, is committed to the success and compliance with rules that advance the principles of our security, sustainable animal agriculture, food safety and the protection of human health. We pledge our resources to make this commitment a reality by working with FDA to achieving that objective. We treasure the opportunity to be here and will provide further statements comprehensively in writing. In closing, I reflect on historical debate that has been taking place in this country for the past 72 years. Although the disease differs dramatically from BSE, there were groups that have indicated since 1929 that 64 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 one day we are going to have a outbreak of foot-and-mouth disease in this country. that is likely. The message is that our regulatory agencies are apparently doing some things right. This applies to BSE. Not Again, everything that should happen in life will happen. Applied to the science of disease transmission, unless the risk factors are present, cause and effect, Mr. Chairman, will not be realized. I thank you. DR. LUMPKIN: Dr. Franco. Are there any questions for Dr. Franco? DR. SUNDLOF: Yes, have I one. Thank you, Don, you and, I think, two or three other speakers have said that the risk at this time is at an all time low for the introduction of BSE to this country. Can you list some of the factors that account for that? I mean, the rule is in place. We have import Are there bans, we have our three firewalls. other things based on the epidemiology of the 65 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 disease or other contributing factors that have led you to the conclusion that the risk is lower than it has been? DR. FRANCO: Well, I did start off by looking at the complexity of the diseases, and I am very conscious of that. However, if you look at the things that first, by the industry, voluntary controls. In 1989, at Lonnie King's office, the rendering industry committed not to process sheep. And we went out and did just that, because that was the only available knowledge at the time. voluntary, and we did it. It was We then went out and We we looked at other aspects of our security. looked again at what was happening in Europe. We have been to Europe. many times. We have been to Europe But these We looked at research. diseases are, by nature, very, very complex. The answers don't come readily. So what we did, we looked at the rule, what you imposed on us. Some of the suggestions were hazard analysis, use of pathogen food safety. And I don't know I mean, what else we could do as an industry. we also looked at what was not done in Europe and did a comparative analysis of what we did. 66 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 And I think, again, without being repetitious or in any way redundant, that we have done what we need to do, both as an industry and as a government. Thank you. DR. LUMPKIN: Dr. Franco. We have reached the time for our break. the back. There is coffee and other things in Please avail yourselves of it. And Thank you again, we will restart at a quarter till. restart the hearing at 10:45. So we'll Thank you. (A recess was taken.) DR. LUMPKIN: If I could ask you to take your seats, we'll get started here. Before we get started with the next group of presenters, Dr. Sundlof asked to make a few comments, so I am going to turn the meeting over to Dr. Sundlof for a few minutes. DR. SUNDLOF: Thank you, Mac. I just wanted to say that the reason that I think we kept BSE out of this country is thanks to a lot of the folks in this room who have been very active and supportive of the feed rule and trying to do the best job that 67 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 you possibly can in making sure that it has been enforced and that folks are complying with it. So I know you don't get enough credit for the things you do, and I just wanted to pass that along, that we couldn't do this without the help of the states, without the help of the various agricultural industries who play a major role in this. We will be releasing today a CVM update which contains the latest compliance figures for the feed rule, and they have improved from the report that we issued in July. In July we had an overall compliance, when we considered all the industries, the renderers, the licensed feed mills and unlicensed feed mills and some miscellaneous others, like ruminant feeders and et cetera, we had an overall compliance rate of about -- well, about 22 percent of the firms were not in compliance. You see the update that will show that about thirteen percent of the firms are not in compliance. percent compliance rate. So we're up to 87 Again, most of those are the unlicensed feed mills that seem to still have the highest rate of noncompliance. In 68 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 those firms that were found to be out of compliance on one inspection, on reinspection only six percent of them are continuing to remain out of compliance. So the numbers are I think that's going in the right direction. very good. As has been said a number of times this morning we still need to get that compliance rate up to a hundred percent. like we're on the right trajectory. DR. LUMPKIN: Thank you, Steve. Looks Our next speaker is Mr. Robert A. Frish, who is corporate counsel for Darling International, Incorporated, of Irving, Texas. MR. FRISH: Good morning Mr. Chairman. I am Robert Frish, corporate counsel for Darling International, Incorporated, a rendering company with its corporate offices located in Irving, Texas. I'd like to thank you for opportunity to comment on behalf of Darling International on the status of the FDA's prohibition on the use of mammalian proteins in ruminant animal feeds. Please be advised that Darling International will be submitting written comments supplementing today's presentation that more thoroughly responds to the agency's notice. 69 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Ensuring biosecurity and the safety of the food supply is an overriding concern for Darling International. Every year the American rendering industry provides a vital societal service in protecting animal and human health, effectively controlling or preventing the spread of diseases associated with animal tissues by removing and processing close to 50 billion pounds of animal and poultry by-products generated by the livestock, meat and poultry industries. As one of the largest independent rendering companies in the United States, Darling safely collects and processes more than seven percent of the total volume of these raw materials through its facilities located in 22 states. In 1997, the FDA prohibited the use of mammalian tissues in ruminant animal feeds as a precautionary measure in order to prevent the transmission of TSE diseases to ruminant animals, such as BSE, despite the fact that BSE has never been detected and remains undetected in the United States. Even while acknowledging the abundant scientific uncertainty that existed as to the origin and 70 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 transmissibility of the disease, the FDA nonetheless adopted the rule as a measure to prevent, quote, "The establishment and amplification of the disease should it ever occur in this country," unquote. The agency further determined that the absence of compelling scientific evidence did not warrant any other protein feed ingredients other than specified proteins derived from mammalian tissues in ruminant animal feeds. Darling International believes that the scope of the current rule sufficiently meets its stated objectives. Experts agree that feed safety must be built on risk-based scientific expertise. There is currently no compelling risk-based scientific evidence to support expanding the current feed ban to include other rendered materials, eliminating the exemptions for certain ruminant proteins previously determined to present no risk, such as blood and blood products, or to prohibit the feeding of rendered proteins provided by ruminant animals to other animal species. current rule, surveillance program, import restrictions and marked differences in animal The 71 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 production and feeding practices between the United States and European countries collectively make the likelihood of BSE occurring in the United States negligible. There is therefore no need to reopen the rule, and to do so is not scientifically justified nor warranted. Rather than altering the current scope of the rule, the agency should consider addressing the way in which they follow and enforce the rule's parameters. Much in the current surveillance system could have been avoided had the FDA initially mandated the licensing of rendering facilities. At the time of the rule's inception, the agency would have known who the renderers were and what materials were handled and produced by each facility. The agency would have also been able to distinguish transfer stations that handle commingled materials for a processing facility and nonrendering plants, such as those handling used cooking oils to produce yellow grease and feed fats, and would have disregarded them from unnecessary inspection criteria. Many states currently issue state rendering licenses and 72 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 permits to operate. So additional federal licensing requirements would not have presented an undue burden provided clear guidelines were established. Licensing could also assist in advancing the rendering industry's credibility. It is up to the rendering facility to determine what type of facility it will be, depending not only on the raw materials handled but the type of finished proteins it seeks to produce. Just because a facility handles exempt raw materials such as porcine or poultry meal does not mean that it is going to sell exempt material. Once the facility declares whether it will handle exempt raw material only, exempt and non-exempt raw materials in a manner consistent with the rule or commingled raw materials as restricted-use proteins, guidelines could be created to delineate the compliance parameters that must be adhered to. At the same time, FDA compliance inspectors should be trained to be familiar with rendering facility operations and how such operations are performed under the rule. Too often the inspectors are unfamiliar 73 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 with how the facility operates or inspect for issues that are not covered by the rule, resulting in erroneous notations of noncompliance for that facility. FDA, APHIS and members of the rendering industry should consider jointly developing training and educational program that would set forth the rendering plant compliance inspection guidance for federal inspectors. Properly trained inspectors would further eliminate erroneous noncompliance citations and yield more accurate inspection data. Penalties for noncompliance could be created ranging from warnings, monetary sanctions, injunctions and criminal penalties based on the particular licensing criteria that the FDA would establish. When the FDA established the rule, it was noted that it would implement the vigorous enforcement program designed to prevent use of proteins derived from mammalian tissues in ruminant animal feed. It was the agency's intent to create a mechanism designed to limit the ability of the BSE to develop in this country. The rule provides this agency with the 74 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ability to issue injunctions and post criminal penalties and seize, adulterated or misbranded product. However, to date enforcement activities for noncompliance with the rule has amounted to little than the issuance of warning letters. Moreover, the agency's compliance and inspection reports reflect inconsistent enforcement of the regulations established by the rule. In order to ensure that the rule measures up to the FDA's intended goal, the FDA must be willing to diligently enforce compliance with the tenets of the rule in a consistent fashion. Instead of expanding the scope of the current rule to include more items subject to inconsistent surveillance and enforcement programs, the FDA should develop and adhere to a strong enforcement policy that not only mandates compliant behavior but also penalizes noncompliance accordingly. Clear and concise enforcement guidelines providing for monetary penalties for noncompliance must be established, along with provisions for other actions, such as mandatory recalls, cease-and-desist orders and suspension of 75 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 operations until noncompliant actions are corrected or abated. If you're going to have inspectors out there, it is important that they be thoroughly and properly trained in all nuances of the regulatory requirements to ensure consistency and credibility in inspection activities. Matters that are not governed by the rule should not be part of the scope of the investigations unless there is a direct impact on compliance, such as the measures in place to prevent commingling of materials. Special attention should focus on familiarizing inspectors with the rendering process to avoid inconsistent inspections and the subsequent dissemination of misinformation related to the industry compliance to the rule. There's a problem with sending out field staff to conduct inspections who view their role as simply information gatherers and they don't know the boundaries of what to inspect. The inspectors openly acknowledge that they know nothing about the rendering industry or the facilities that they inspect. They conduct the inspection of a company for 76 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 compliance to a rule that they themselves are uncertain how that operation is supposed to behave in order to be in compliance. The inspectors are fact-finders who ask questions with an investigatory slant that may or may not be germane to the issues of compliance to the rule. All of the information generated by their investigation is sent up the line for someone else to interpret. This often includes the information gleaned that has no direct bearing on compliance. This type of information, otherwise irrelevant to compliance, is posted by the agency without proper interpretation and stimulates unnecessary and otherwise unwarranted public concern. The inspection data posted by the FDA on their web site most show compliance or noncompliance for inspected facilities and disregard information that does not have any relevance to compliance. If the published inspection reports indicate whether or not a facility is compliant with the rule, the public's perception of compliance will improve. It would also be extremely worthwhile for the agency to provide prompt 77 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 feedback to the managers of inspected facilities. Regarding their compliance status to the rule, currently many managers do not know the inspection results until after the agency has posted its findings on the internet. Increased communication with regulated parties will increase likelihood of compliance with the rules. One issue of paramount concern that is outside the scope of the current rule is the status of the raw material itself. When the rule was first promulgated, dead ruminant animals and unprocessed ruminant-derived viscera, bone, fat trim, meat trim, blood and other animal products and by-products that are deemed to be inedible or unsuitable for human consumption were mainly handled and processed by the rendering industry. Yet over the years economic conditions and unforeseen marketing changes have negatively impacted the rendering industry, precipitated in part by the rule, coupled with rising international concern about BSE and pressure from Europe on the international community to adopt E.U. food safety principles and policies. As a result, 78 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 rendering facilities now charge for their services. This has prompted an increasing number of animal producers, locker plant operators, meat processors, and retail food chains to utilize alternative methods for the disposal of these raw materials. In short, the percentage of these raw materials that are collected and processed by the rendering industry is steadily declining. If it doesn't go to a rendering facility, do you know where this material will end up? The origin and ultimate disposition of raw materials are not traceable when methods other than rendering are used. Rendering companies already possess the necessary infrastructure to allow for trace-back of raw materials and trace-forward of finished products. Only rendering companies are held accountable and required to document and maintain written records suitable for governmental agencies to trace raw materials back to their source and the finished products forward to the end user. The current rule only prohibits the intended inclusion of proteins derived from 79 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 mammalian tissues in ruminant feeds. materials that are disposed of through Ruminant nonrendering means such as composting, landfill or on-site burial can still enter the food chain by a variety of means. The spread of composted materials of ruminant animal origin on land that is used for livestock grazing and/or hay production is permissible under the current rule. Domestic and wild animals, including ruminants, may have direct exposure to unprocessed ruminant raw materials that have been improperly buried, composted or placed in landfills. This is of particular concern because scientists believe that chronic wasting disease, a TSE affecting deer and elk, is transmitted when healthy animals are exposed to soil contaminated by the remains of an infected animal. It is believed that the soil can remain The unregulated use contaminated for decades. of nonrendering alternatives could lead to the amplification of the disease that the rule was implemented to prevent in the first place. While incineration is a viable option for disposal of these raw materials, it is both costly and environmentally unsuitable. 80 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Other alternatives to rendering for the disposal of raw materials, such as composting, on-site burial or landfills, do not provide adequate biosecurity with respect to BSE as well as other infectious diseases. The best means of attaining and maintaining biosecurity is to regulate the disposition of all raw materials of ruminant origin by having licensed rendering facilities collect, transport and process them in order to limit exposure of domestic and wild ruminant animals to these raw materials. regulation of these raw materials can be established independent of and in addition to the present feed rule. In conclusion, before the FDA expands the scope of the rule and/or removes any exempt products from the list, in the absence of compelling scientific evidence, to do otherwise the agency should make certain that it has done everything it can do under the current terms of the existing rule. The agency should focus on how to improve performance and compliance under the present rule parameters. There should be The better-developed and concise surveillance and 81 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 enforcement guidelines established by the agency, including the development and implementation of an appropriate penalty schedule that would mandate compliance. Federal compliance inspectors must be properly trained both in nuances of the rule and how the rule applies to the industry that they inspect. Establishment of federal licensing guidelines would further assist the agency in this direction. Most of all, the agency must address the need to regulate the raw materials from the outside by requiring that only licensed renderers collect, transport and process the materials. To permit continued disposal of these materials through nonrendering means undermines the intent of the rule; that is, to prevent the establishment and amplification of the disease should it ever occur in this country. Thank you. DR. LUMPKIN: Mr. Frish. Are there questions? (No response.) Thank you, 82 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Custer. DR. LUMPKIN: Thank you again. The next speaker is Mr. Kevin He vice president of technical services for American Proteins, Incorporated, in Cumming, Georgia. MR. CUSTER: I'd like to thank the agency for the opportunity to make comments on this issue. Today I am representing American Proteins, a renderer in Georgia and Alabama, processed poultry by-products. I have a brief statement which I will read and will present for the record. The final rule established at Section 589.2000 has the stated objective to prevent the establishment and amplification of the agents of bovine spongiform encephalopathy in the United States cattle through feed and thereby help minimize any risks from such agents to animal or human health. been and is being met. In addition to the rule, other safeguards are in place to meet the objective of the rule. APHIS/USDA introduced import The objective has restrictions very soon after the initial Great Britain diagnosis, and over the years has added 83 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to those restrictions as warranted. FSIS/USDA has submitted over 12,000 cattle from nearly every state and Puerto Rico for examination with no evidence of BSE or TSE found. In addition to government initiatives, several industry programs have been initiated, most notably third-party certification administered by Cooke and Thurber for rendering and animal protein blending facilities. A compliance rate of 98 percent was noted, two percent difference from a hundred percent. It's reported there are facilities yet to be inspected. In summary BSE does not exist in the United States. Broadening the list of animal proteins prohibited is not warranted by scientific scrutiny. And I would again like to thank the agency for this opportunity. If there's any questions, I'd be happy to answer them. DR. LUMPKIN: Mr. Custer. Are there any questions from the panel? (No response.) Thank you, 84 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Griffin. DR. LUMPKIN: Thank you, sir. The next speaker is Mr. Dennis He is chairman of the Griffin Industries, Incorporated, in Cold Spring, Kentucky. MR. GRIFFIN: Thank you. Ladies and gentlemen, I'm here to submit my testimony today in response to your agency's request for comments on the possibility of opening up the regulation that was then listed in Federal Register on October 5th, 2001. I'm speaking today on behalf of our family business, Griffin Industries, which has been in the rendering business for over 58 years. We are based in northern Kentucky and serve many animal agricultural members throughout the midwest, the southeast and the southwest part of our country. Our company is in full compliance of the ruminant-to-ruminant food regulation and HACCP programs in all its processing facilities, and it is participating in the Animal Protein Producers third-party certification program, which, with increased plant and procedure inspections, has helped bolster FDA's inspection program. 85 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 I wish to begin my comments by saying that BSE has not been detected in the United States. It has been over fifteen years since the first known case of BSE was discovered in the United Kingdom, with many thousands of confirmed cases throughout Europe. The disease has been a European-domiciled disease, with only one other case reported in other sections of the world, but it had ties with European suppliers. We strongly support the existing action taken by your agency in June of 1997 to build a firewall against BSE and see no reason to change or modify CFR 589.2000. We as Americans have a good program in place, and, with continued awareness and enforcement by your agency, will provide our consumers the continued confidence they need in U.S. meat products. The highest awareness level in food safety history has been created by actions taken by the agency and by industry such as the ruminant-to-ruminant feed ban, the ongoing testing of suspect animal brain, which is currently approaching sixteen thousand animals that have been tested. The industry's 86 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 third-party inspection program has our industry participation of over 98 percent -- unheard of in past practices. Being in this industry for over 40 years, I've never experienced such an effort on the part of animal agriculture, and especially our industry, and working so closely with your agency in this precautionary program against this foreign disease. Since the discovery of the first BSE case in 1986, scientists still do not have clear evidence for the cause of BSE or the new version in humans, or that BSE has ever crossed species boundaries. There are new theories and hypotheses developing throughout the world as more research takes place. And with that, I'm sure that there will be a true cause of BSE discovered in the near distant future. In closing, we support working with the current regulation and increased effort for enforcing it. Changing the rules sends a wrong message to consumers and protein users domestically as well as internationally that something is wrong with our current efforts. 87 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 And this is clearly not the case. broken, don't try to fix it. If it isn't Remember, we have not discovered any BSE in the United States, and with fifteen years behind us without any detection, further changes to our safety measures are unwarranted. Thank you for giving us the opportunity to respond. questions... DR. LUMPKIN: Mr. Griffin. Any questions from the panel? (No response.) DR LUMPKIN: Thank you, sir. Thank you, And if you all have any The next speaker this morning is Mr. David Kaluzny from Kaluzny Brothers, Incorporated, Joliet, Illinois. MR. KALUZNY: Mr. Chairman. Kaluzny Brothers is a 55-year-old independent rendering firm serving the northern half of Illinois, Southern Wisconsin and Northwest Indiana. We process Thank you, bones, fat, offal and hides from both ruminant and nonruminant animals, as well as various 88 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 greases. I will refer to my questions as they were numbered within the request for data. Number 1. We do not see any need to change the enforcement activities of the agency. Rather, more importantly, we see a need to improve the accuracy and completeness of the reporting of the agency's inspections. We feel this reporting has done more to cause concern amongst the public than any actual noncompliance with the rule that has actually occurred. Number 2. asked: This question really And we feel Is the rule doing its job? yes, it is. Its intent was to create an additional firewall around our beef industry. As we sit here now, we do not have BSE in this country. I dare say we never will. This disease first emerged fifteen years ago and has never been found in this country. And today 99.999 percent of all cases have been confined to Europe; 99.9 percent in England, the other 0.99 percent in the rest of Europe and only one case in Japan. Furthermore, as a country we've been vigorously looking for signs of this disease by examining thousands of cattle breeds 89 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 every year. We have never found BSE. It seems to me, again, the rule is working. The ban should not be broadened in any way either. It works now, and, more importantly, there is no new scientific evidence that has come forth in the past four years that in any way would suggest that we make any changes. Number 4. The FDA should not require dedicated facilities for the production of animal feeds containing mammalian proteins. The current rule already addresses the issue of prevention of commingling quite adequately. Procedures and controls are already in place and being used to prevent commingling and contamination in rendering facilities. Number 5. The agency should not require dedicated transportation for animal feed containing mammalian proteins. This issue as it relates to commingling or crosscontamination is, again, already addressed within the rule and, at the same time, is currently not a problem. To require such at this time would only needlessly add to costs while not adding to any further protection of 90 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 animal feed. Number 6. We would not oppose FDA licensing of renderers as it relates to the current rule in effect, CFR 589.2000. Number 7, the FDA should not revoke or change any of the current exclusions allowed for in the rule. There is, again, no new scientific evidence that has come forth that would even remotely justify any such move. Number 8. The FDA does not need to add to the list of prohibited materials and language relating to poultry litter. The rule addresses protein from mammalian tissue, and, as such, already addresses this issue. Further elaboration or definition would only serve to confuse. Number 9. No, the exemption It should not be removed for pet food either. is not normally fed to animals for human consumption. Number 10. The current recordkeeping requirement, in light of annual and sometimes biannual inspections, seems adequate at one year. If, however, the agency can see a need for further data beyond a year, 91 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 we would support such a move if it makes the rule any better. Number 11. The FDA should not change the rule to require labeling of the specific type of mammal used in the production of a specific protein. Such a need is nonexistent in light of the requirement to label "Do not feed to cattle or other ruminants." Beyond that, this would only serve to confuse feeders, feed mills, blenders, cattlemen and nutritionists who already have a fully understood list of feed ingredients they work with and that are used nationwide. Number 12. The current It is It was cautionary statement should stand as is. clear, to the point and well understood. designed that way. If, however, the agency knows of individuals feeding deer, elk or bison with prohibited proteins, I would support such a change. However, I don't know of any with such animals feeding them any animal proteins, and I know of no such commercially available feed for that purpose either. As far as I know, number 13, there is no currently available accurate and 92 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 efficient analytical method for detecting prohibited mammalian protein in feeds. Number 14. I see no need here for any more enforcement authority; rather, an assurance that all inspectors, state and federal, are working, quote, unquote, out of the same songbook, so to speak would help keep uniform assessment across the country. Number 15. Private certification programs have worked tremendously in the rendering industry. Through APPI we have engaged the use of Cooke & Thurber of Madison, Wisconsin, to certify, plant by plant, renderer compliance with the rule, and therefore intent and actual manufacture of safe feed ingredients. We had the honor of being the first plant to go through the compliance audit, and we were proud to do so. Just as important, third-party audits also give the agency the ability to point to an outside entity that can verify compliance with the rule. Number 16. Regarding the importation of feed ingredients, the restrictions should be based on the incidence or non-incidence of BSE in the country of origin. 93 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Number 17. Regarding what additional measures could be taken to further guard against BSE, I offer the following. I will not offer any views on preventing CJD or variant CJD as there is still no known cause for such, and as recent as two weeks ago scientists in Great Britain are claiming that variant CJD could not be caused by eating BSE-tainted beef. But with regards to BSE itself, four and a half years ago, in offering comments before the agency on the then proposed rule, I called for an all-out effort to eliminate our country's only known farm animal TSE: Scrapie. Quote, "Therefore, let us make an all-out effort to eliminate all scrapie, our only known TSE, from the U.S. Let us start with an immediate destruction of all scrapie flocks and a total indemnification program for the owners. And if TSE elimination is that important, let us complete that phase in 12 months. Let us rid ourselves of that agent all together. "Australia and New Zealand did it years ago and they have far more sheep than we have in the U.S. Why haven't we?" That was four and a half years 94 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ago I said that. To that, today I would add that we could certainly import enough scrapie-free sheep from both Australia and New Zealand to aid in the indemnification process at the same time. Secondly, with regard to additional measures, I would like to point out to the agency a growing tendency within various states to allow for nonrendering disposal of animal by-products. and landfilling. Here I refer to composting These methods serve to remove this material from biosecure rendering and at the same time remove it from the traceability offered by the rendering industry in conjunction with the rule. In summary, the current rule as it stands is good, and even more importantly, it is working. There is no scientific reason to change any of the parameters of the rule in any way. No new scientific elements have come to light in the past four years. Furthermore, we do not have BSE in this country. never will. And again, I dare say, we Our cattle are now even more protected than we have ever had them before from 95 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 contracting BSE. Let's concentrate on eliminating our TSE of scrapie and eliminate people's fears of our cattle succumbing to BSE through scrapie, as unfounded as that may be. Thank you for your time and consideration. DR. LUMPKIN: Mr. Kaluzny. Any questions? (No response.) DR. LUMPKIN: Thank you, sir. Thank you, Our next speaker is Mr. Gerald Smith. He is president of Value Proteins, Incorporated, in Winchester, Virginia. MR. SMITH: Good morning. I'm Gerald F. Smith, Jr., president of Valley Proteins, Incorporated, Winchester, Virginia. Founded in 1949, Valley Proteins and its subsidiary, Carolina By-Products, is one of the four largest independent recyclers of animal by-products and waste cooking oils in the United States. Our firm operates 22 total facilities, including 14 manufacturing plants for recycling animal by-products located along the eastern seaboard 96 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and southwest region of the United States. We employ over 1300 individuals and operate a fleet of 450 trucks. In the year 2000 we recycled over 3.4 billion pounds of waste materials which was collected from over 65,000 restaurants, supermarkets, farmers and animal and poultry processing facilities located in 17 states. Our organization fully supports FDA Regulation Section 589.2000 enacted in 1997. The U.S. rendering industry took a leadership role in promoting the fire walls around the U.S. cattle industry which resulted from this regulation. In fact, our industry forfeited marketplace for twelve to eighteen percent of our animal protein products when this regulation was enacted. When enacted in 1997, this regulation was based on the best scientific data then available and on the recommendations of the World Health Organization. All exemptions to this regulation are also based on the best scientific data available in 1997. Since 1997, BSE has declined significantly in the United Kingdom, but new cases and increased incidences of BSE have occurred throughout the remainder, 97 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and most recently in Japan. What has not changed since 1997 is that the U.S. remains BSE-free. These new and increased cases outside the U.K. can be attributed to the export of infected animals from the U.K. and to meat and bone meal which was produced from such infected animals. While it is not scientifically conclusive that the spread of BSE was caused by meat and bone meal derived from infected animals, there certainly has been a strong correlation to the consumption of this product. First, I believe that if BSE were to occur in the United States, it would almost certainly be through the importation of infected animals, animal products or animal by-products. The U.S. government has a duty to increase funding which will allow the FDA, the USDA to protect our country where this disease will almost certainly enter our country: ports or borders. At our With our current concerns over bioterrorism, it is more important than ever that the U.S. be extremely vigilant to make certain that diseases and substances which can harm our human and livestock populations are detected and stopped before they enter our 98 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 country. Second, I believe we have an adequate program of surveillance for BSE, and if this disease were to occur in the United States that it would be detected at the earliest possible time. Our USDA is and has been doing We an excellent job of surveillance for BSE. have tested a greater population of animal brains than that suggested by the World Health Organization for the size of our livestock population. Even more important is that USDA has stepped up surveillance at facilities that receive downer cattle, since this is by far the most likely point for an infected animal to enter our food and/or our food chain. Third, while I believe we have very adequate firewalls to prevent BSE from entering our food and feed chain and prevent amplification of this disease should an infected animal be found in our country, these regulations are only effective if thoroughly enforced. Our company has entered into a voluntary third-party certification because we believe that 100 percent of our facilities must be in compliance with this regulation. I 99 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 support additional funding which would allow FDA each year to inspect an adequate number of dairy farms, cattle feeding establishments, feed compounding facilities and rendering facilities to assure compliance with this regulation. E.U. and especially the U.K. had adequate regulations. What the Europeans did was fairly The to adequately enforce these regulations, and as a result, the European consumers lost faith in both their food industry and their governments. Let us make sure we don't follow their example. In conclusion, I fully support the FDA's regulation Section 589.2000 which restricts the feeding of ruminant derived by-products to ruminants. I am, however, opposed to reopening this rule, to expanding this rule, or to revoking the exemption for any products which are not exempted by this rule, since I believe any change to this regulation should be based on sound scientific data. Such scientific data has not changed since this rule was enacted in 1997. I believe surveillance for BSE within the United States is adequate but must be a made a priority for funding so that USDA may 100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 continue to provide our overseas customers with the assurance that U.S. agricultural products are safe and free from BSE. I'm very concerned about the enforcement of this regulation with our surveillance at our ports and our borders, and I believe that most important -- excuse me, and I believe that more effort and resources must be provided toward making certain that the firewalls can prevent feeding ruminant proteins to ruminants and which would prevent the entry of BSE into our food chain were BSE to occur must be supported by significantly improved oversight by the FDA. On behalf of our employees, I take this opportunity to thank you for the opportunity to provide this statement today and for the FDA's efforts to keep the United States BSE-free. DR. LUMPKIN: Mr. Smith. Any questions from members of the panel? (No response.) DR. LUMPKIN: Thank you again. Thank you, 101 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Pearl. The next speaker is Dr. Gary He is president and director of technical services with the Fats and Proteins Research Foundation of Bloomington, Illinois. DR. PEARL: Thank you. This opportunity to offer comments to the Food and Drug Administration solicitation of information pertaining to its animal feeding regulation as referenced in the Federal Register October 5, 2001, Volume 66, Number 194, is very much appreciated. These comments are being made on behalf of the Fats and Proteins Research Foundation. FPRS is organized to serve the rendering and its associated industries. The rendering function is that of recycling the co-products resulting from food animal production. The rendering and its ancillary support industry has ecologically, economically and via the most biosecure procedure processed the more than 50 billion pounds of inedible animal tissue generated annually into products of value for a variety of useful purposes. Rendering represents the collection of animal raw materials from 102 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 slaughter, from packing, from processing, food preparation and fallen animal sites for transport to process controlled facilities, heated to a temperature higher than that required for sterilization and removes the moisture, a process not afforded by any other permissible alternative. The fat is extracted from the protein and the fat and protein are then used as animal feed ingredients or for other important industrial uses. FPRF was organized in 1962 to provide an institution which will direct and manage a research process that results in an enhanced current usage and the development of new uses for rendered animal products in a biosecure methodology. FPRF is a nonprofit, nonlobbying organization, as defined by Illinois statutes. Approximately 100 industry members voluntarily support and contribute in a cooperative effort to focus research resources to the individual research projects. Over 125 projects have been assigned and completed since 1994, and all of these projects and their researchers are strongly encouraged to publish the results in peer reviewed journals with 103 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 nearly 90 percent of the projects resulting in published or for public knowledge usage. Though there were 17 specific questions posed in the October 5th, 2001, document. These comments will not address each question directly, but such will be supplied within the written comment period to follow. The 21 CFR 589.2000 regulation has functioned within its objectives to prevent the establishment or the amplification of the infectious agent, the bovine spongiform encephalopathy, to the U.S. cattle population. Thus, in a composite review of the questions, there is little need to duplicate the process initiated 1996 and resulting in the August 1997 prohibition of specified animal proteins in ruminant feed. The specifics of that prohibition incorporated the best scientific information available, but it interpreted that information by instilling a degree of cautionary principle as added safety, even while knowing of the BSE-free status in the U.S. as validated by extensive testing. The intensive compliance accompanying the establishment of the rule has 104 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 now been supplemented with the development and implementation of third-party certification programs. Of importance are those of the APPI organization supervised or completed by Cooke and Thurber directed at the rendering industry, and the facility certification institute at the feed manufacturing industry. Both have resulted in validation of facilities that produce a very high percentage of all animal proteins and feed manufacturers producing a significant tonnage of all the mixed feeds. These and other voluntary actions have been taken to ensure compliance with government regulations, while demonstrating an active commitment to the feed and food safety in the animal health, public health sector. Surveillance initiatives and numerous associative regulations initiated in 1986 and enhanced throughout this subsequent 15-year period have provided no evidence that an enhanced risk for the emergence of BSE has been altered. This foundation has been promoting the research attention to the identified priorities established by the agency and referenced in the August 1997 regulation. Among those were inactivation of the causative agent, 105 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 transmission among inter and intra species, diagnosis with emphasis on preclinical procedures, detection procedures for individual species protein in meat and ingredients and feed, and the epidemiology of the respective TSEs. With the recognition of fragmentary research contributions filling a few voids, in composite most of the outlying priorities still remain. conclusive answers. They remain without These priorities were essentially restated in the summary comments resulting from a USDA/ARS BSE workshop held March 15, 2001. There is not sufficient scientific evidence to alter the regulatory plan that was established, initiated and validated for compliance as outlined in the final rule of August 1997. Additionally, this foundation has, since its inception, retained a focus on the biosecurity principles provided by the rendering procedures. Recent validation that proper time/temperature processing inactivates viral and primary foodborne pathogens -- and I name in specific Salmonella species, Listeria 106 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 monocytogenesis, Clostridium perfringens and Campylobacteria jejuni -- in by-products derived from slaughter of animals for food purposes. This assurance is not available for the other alternatives for rendering and certainly becomes increasingly important as we face new biosecurity challenges of today. Animal agriculture has, and now more than ever, depends upon the sanitary, biological secure, ecological and environmental processing and the infrastructure of the rendering industry as a vital synergistic means of utilizing approximately one-half of all livestock and poultry tonnage produced in the U.S. each year. In summary, the 21 CFR 589.2000 rule instituted as a firewall regulatory adjunct to a series of precautionary practices is not in need of any extensive modifications or changes until which time science and research findings dictate. Thank you again for this opportunity. DR. LUMPKIN: Thank you, Dr. Pearl. 107 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Dr. Lumpkin. Any questions? (No response.) DR. LUMPKIN: Thank you, sir. The final speaker of the morning before we take our lunch break will be Richard Sellers. He is vice president of feed control and nutrition of the American Feed Industry Association in Arlington, Virginia. MR. SELLERS: Thank you The American Feed Industry Association is the national feed trade association representing feed manufacturers, ingredient suppliers, equipment manufacturers, pet food manufacturers, animal health manufacturers, and distributors and other suppliers to the feed industry. AFIA members manufacture 75 percent of the primary commercial feed in the United States. Therefore, our members are affected by these regulations, and I present these comments on their behalf. More thorough comments will be provided to the docket prior to November 21st. We appreciate the agency offering this opportunity to review the rule and 108 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 make comments on the current issue, state of science of transmissible spongiform encephalopathies, or TSEs. Only by collecting comments and information can the U.S. have the best prevention program. In fact, AFIA believes the risk of BSE in the United States is near zero and that the vigilance and attention to detail by our government and the industry have resulted in keeping the U.S. BSE-free for over 16 years. The three firewalls mentioned by speakers today are very important. And AFIA pledges its continued commitment for compliance to the second firewall, which is the feed rule. We continue to support the FDA's hundred percent inspections and believe our continued efforts to educate the industry about compliance with this rule is the best risk reduction effort we can take. In fact, the Facility Certification Institute, which was created by AFIA as an independent third-party inspection system, is very much an educational program designed to certify facilities' compliance with this rule. AFIA believes the top enforcement priority of the agency should be 109 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 education, followed by aggressive action against any firm or individual knowingly feeding prohibited protein to ruminants or distributing such material for that use. The final rule is basically a labeling and recordkeeping rule, and compliance in the latter area of recordkeeping has been nearly perfect. We believe the labeling compliance is more complicated than the inspection numbers released by the agency. We have met with agency officials to express our concerns about the inspection form and inspection reporting. We fully support CVM's effort to fully clarify the compliance issues in its efforts to reduce subjectivity in the inspection form. AFIA has taken an active role in promoting inspection and compliance with the states and seeking funding for them where appropriate. We believe all states should be, and many are, active partners in achieving full compliance with this rule. We urge FDA to fully fund these state inspections where appropriate. With respect to the adequacy of the current rule, AFIA believes the rule is 110 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 adequate and further education and compliance efforts are the most important effective way of reducing risk of BSE coming to the United States. Such a continued, sustained effort would likely be far more effective in reducing risk than any changes to the current rule. We believe the exemptions in the rule are still scientifically justified; however, there needs to be a regular revisiting of the rule to strengthen it if new risks are identified or to remove restrictions if no longer justified by the scientific assessment of risk. AFIA believes that neither dedicated facilities nor vehicles will preclude all risk. We need full compliance with the current rule, which is dependent on continued extensive education and appropriate enforcement actions. AFIA acknowledges that commingling incidents have occurred in the United States. They have been small in number and many are of minor consequence. This low incidence is evidence of the industry's commitment to maintaining a BSE-free United States. Regarding licensing of firms to utilize prohibited protein, AFIA believes this 111 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 would detract from the already limited funds to enforce the current rule. Licensing firms would rob the resources for the more important activities of education and compliance. AFIA strongly supports the current cautionary labeling statement and does not believe that pet foods, except salvage pet foods, should be labeled with the statement. This would confuse consumers, as FDA agreed in the 1997 rules preamble. Again, FDA should place its efforts in educating the salvage dealers in gaining compliance using measured enforcement. The recordkeeping provisions in the current rule are required to document compliance with the rule. The long latency period for this disease would require considerable record retention for investigatory purposes. The cost benefit of such a longer time is very high, as little is gained from maintaining records for five to ten years. Again, education and compliance with the rule should be the principal way of reducing risk. The agency's rationale for one-year record retention is as valid now as it was in 1997. 112 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Some might request the agency change the ingredient listing to require species-specific listings. This is a very costly undertaking and would be a reverse step to the 30 years of acceptance and use of collective terms. And I might add as nutritionist, there are no requirements for ingredients; there requirements for nutrients that may be supplied by a number of ingredients. A much easier tasks is to look for the cautionary statement required for products containing restricted use protein products. The statement should be a clear and prominent one, and one that assists the producer in assuring compliance. As indicated earlier, the current cautionary statement is adequate. We believe farmers have a clear understanding of the term "ruminant." AFAI is clearly in favor of a continued education campaign which will likely prove more effective in accomplishing the intended protection than expanding the cautionary statement. AFIA believes the industry definitely needs test methodology that is both 113 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 sensitive and specific in order to ensure compliance and investigate illegal activities. Also we believe false positive tests increase the perception of violations. So we support the continued effort for research in this area. As mentioned earlier, AFIA created the Facility Certification Institute to further educate the industry and certify compliance with this rule. AFIA and FCI believe the agency should demonstrate strong support for this effort. The Facility Certification Institute filed a draft partnership agreement with FDA yesterday to further enhance FCI's efforts and to recognize the unique nature of a potential formal relationship of the two organizations. This partnership would allow recognition of FCI certification by FDA and would encourage FDA to shift inspection resources from certified facilities to other compliance and educational efforts designed to reduce the risk of BSE in the United States. AFIA is concerned about the potential for the introduction of BSE into the U.S. via imports. The current inspection process for imports is not adequate, and more 114 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 funds should be directed to preclude the entry of restricted products. There is a real need for the agency to further strengthen this first important firewall. AFI believes, finally, that the agency has been diligent in carrying out its responsibilities commensurate with reducing the risk of BSE being established and amplified in the United States. However, the Administration's support lagged during the two-year period of 1999 to 2000 as states were unable to secure complete funding for investigation and the number of inspections were reduced from the first two years. Only after a series of negative media articles appeared earlier in this year did more funds and resources materialize to finish with a new commitment to finish all the inspections. commitment was made 1997 to finish the inspections within the first two years, but resources appear to have been moved to cover other hot agency topics. The see-saw commitment to the inspection program is unfortunate and unwarranted for an industry which has cooperated This 115 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 with the agency on an ongoing, constant basis for four years. resources. We need these inspection The American people deserve nothing less than the agency's full commitment to preventing this devastating disease from entering the U.S. We pledge our continuing commitment to a goal of 100 percent inspections, 100 percent compliance, and assuring the federal/state agencies have the necessary resources to make that happen. I thank you for the opportunity to submit these comments, and I look forward to continuing our education and compliance efforts. DR. LUMPKIN: Mr. Sellers. Are any questions? DR. SUNDLOF: Richard, you Thank you, mentioned that enforcement of those that knowingly violate the regulations. Do you think that continued effort is necessary to maintain education for those that are not fully aware of the regulations in place? MR. SELLERS: I do believe that 116 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 there is a continuing education effort that's needed in light of the hundreds of millions of dollars of regulations that we have to deal with from other federal and state agencies. And it's important on an ongoing basis to keep this issue in front. We try to do that with our industry, but there are other -- biosecurity, other pressing things that keep coming out. We sent a number of our videotapes and a number of your compliance guides and our compliance guides when requested. And one of the actions of AFIA is an educational effort to provide those compliance documents actually on a different inspection level, on a higher inspection level than the agency practices. DR. SUNDLOF: DR. LUMPKIN: Thank you. Thank you. One quick announcement before lunch. As many of you are aware, Billy Ray Smith is the Commissioner of Agriculture of the Commonwealth of Kentucky. occurrence NASDA president. He is also the Unfortunately, he could not be with us today but he did send a representative, a Dr. Chris Young, as one of the state representatives. He is standing in the 117 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 back. I introduced the other state representatives earlier, and he joined us at later this morning. So I wanted to make sure I had a chance to introduce him and thank him for being here and representing Commissioner Smith. With that, let us adjourn for lunch. And as per the agenda, we will reconvene at 1:15 in this room. Thanks much. (The luncheon recess was taken.) DR. LUMPKIN: It's now 1:15. I'd like to reopen the afternoon session of this public hearing. I have one announcement. If there's is Mr. Ernie Parker in the audience, he needs to call his office. That's Ernie Parker. He needs to call his office. The first group of speakers that will be speaking are going to be representing the National Grain and Feed Association. It's my understanding there's going to be a tag team approach here between 1:15 and 1:30. The speakers will be Mr. Joseph Garber from Wenger's Feed Mill, Inc., in Rheems, 118 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Pennsylvania, and Brad Gottula from the Land O' Lakes Feed in Fort Dodge, Iowa. I think this is Mr. Garber; is that right? MR. GARBER: Good afternoon. The National Grain and Feed Association welcomes this opportunity to provide its thoughts to the Food and Drug Administration's current animal feeding regulations designed to keep the United States free of BSE. I am Joe Garber, chairman of the NGFA's feed industry committee. I am the That's right. nutrition and research coordinator for Wenger's Feed Mill, Inc., in Rheems, Pennsylvania. Also presenting a portion of this testimony will be Brad Gottula, chairman of the NGFA Feed Industry Committee's Legislative and Regulatory Affairs Subcommittee, as well as chairman of our Animal Protein Transportation Task Force. Mr. Gottula is the director of quality assurance and regulatory compliance for the Land O' Lakes Farmland Feed, LLC, in Fort Dodge, Iowa. Established in 1986, the NGFA 119 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 is a nonprofit trade association of more than 1,000 grain, feed and processing facilities and other grain-related firms. Our members operate more than 5,000 facilities and handle more than two-thirds of U.S. grain and oilseeds. In addition to our oral statement, we also will be submitting a written statement for the official record for this rulemaking. We commend FDA for initiating this rulemaking to review its current BSE prevention regulations. As it does so, we believe it is of paramount importance for FDA to continue to base its decisionmaking on the best available science and prudent risk assessment. The entire world is looking to FDA as a model agency for prudent science-based risk assessment. To deviate from that sound course would undermine the agency's moral authority for regulating food and feed safety. Were that to occur, we would likely see the emergence of a hodgepodge of different state laws and regulations to address BSE and an undermining of consumer confidence. We also believe FDA should review its rule from the perspective that not a 120 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 single case of BSE has been detected in the United States. Since 1990 that is viewed as the most extensive of any country in the world, with the exception of Europe, where the BSE agent does exist. This is attributable in large part to an effective and science-based triple firewall strategy implemented by the government that the NGFA strongly supports. Those firewalls consist of import bans, a prohibition on feeding specified mammalian proteins to cattle and other ruminant animals and active surveillance and inspection programs. The NGFA has adopted a BSA prevention policy that pledges our firm commitment to science-based BSE prevention measures. We recognize that science is not static and that the agency and industry have a responsibility to base future decisions on the best available facts that exist. But based on our understanding of the current science related to BSE, the NGFA fully supports the FDA's existing regulations and does not believe that the current ban on feeding certain mammalian proteins to ruminant 121 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 animals should be expanded beyond the restrictions now in place. We support the continued use of ruminant-derived protein as a safe, nutritious and wholesome feed ingredient for species for which it is legally approved. With this groundwork laid, we now would like to respond to several of the major questions posed by FDA in its October 5 Federal Register notice. We have organized our responses to FDA's questions into three broad areas: The scope of the feeding restrictions, enforcement and compliance-related issues, and, as Mr. Gottula will address, operational issues. First concerning the scope of the feeding restrictions. We believe the current FDA rule is adequate to meet the stated objective of preventing the spread through feed of the BSE agent if it were ever to enter the United States. Rather than broadening the rule's objectives, we believe the first order of business is to achieve as close to 100 percent compliance with the existing rule, particularly among multi-species feed mills that manufacture ruminant feed and handle prohibited mammalian 122 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 protein. The NGFA does not believe FDA feeding restrictions should be broadened to include other mammalian proteins unless there's compelling scientific evidence that the ingredient is a vector of the BSE agent. For the same science-based reasoning, we also do not believe FDA should revoke or change the exclusions for certain products allowed in the current rule, nor should the agency add to the list of mammalian proteins that are restricted from being used in feed for cattle or other ruminants. Second, FDA poses several enforcement and compliance-related questions. The NGFA believes that the existing authorities at both the federal and state level, including the states' authorities, to issue stop-sale orders, are strong and effective tools to ensure compliance. We believe a visible surveillance presence by FDA and states is more important to encouraging compliance than additional enforcement authorities. Concerning future enforcement activities, the NGFA recommends strongly that if FDA and state partners adopt a more targeted 123 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 inspection and enforcement plan in the future. We believe the central component of such a plan will be a trace-forward approach in which the movement and use of ruminant-prohibited mammalian protein is tracked from the source to subsequent receivers. We recommend this be accomplished through the development of a statistically valid, random inspection program. We believe this should be augmented by states conducting BSE rule compliance inspections as part of their routine feed mill inspections and commend the Association of American Feed Control officials for including that component in its BSE policy statement. In joint meetings with other animal industry, feed and rendering organizations, we believe it is an emerging consensus that a traceable approach makes sense from a risk assessment and resource allocation basis. As part of such an approach, the NGFA recommends that FDA develop an overall strategic plan to guide its future BSE prevention surveillance and inspection efforts. From an inspection standpoint, 124 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 we believe FDA's first priority should be facilities that manufacture feeds for ruminants and other species and which handle prohibited mammalian protein. Surveillance should also be focused on direct purchasers of prohibited mammalian protein as well as salvage feed or pet food to ensure that the product is being inspected and sold to the appropriate channels. Of secondary importance should be multi-species facilities that utilize prohibited mammalian protein but do not manufacture ruminant feed. As part of the strategic approach we also recommend that FDA and states enhance their coordination of inspections and interpretation of inspection results. In this regard, the recent modification to FDA's BSE inspection checklist are a positive step and should lead to improved uniformity of inspection interpretations and results. FDA also asks what role, if any, that public or private certification programs should play. The NGFA strongly supports government-based inspections by FDA and states as providing the integrity and 125 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 impartiality that's essential to maintaining consumer confidence. The feed manufacturing sector, the NGFA believes that the decision on whether to participate in a public or private certification program should be an individual company decision based upon the perceived value of such a certification vis-a-vis customer preference and/or market demand. The NGFA believes in the integrity of our industry to truthfully attest to their use or nonuse of prohibited mammalian protein and has worked to facilitate marketplace acceptance of individual company-to-company assurances, including contractual guarantees, company affidavits and other self-certification mechanisms such as those that may be requested by certain customers which are responsive to customer needs. The NGFA's feed trade rules and arbitration system as well as the courts provide a time-honored mechanism for enforcing such assurances. Given the breadth and scope of the feed manufacturing industry, the NGFA believes that government actions to mandate or endorse a private sector feed-based 126 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 certification program are neither feasible nor appropriate. While we do not oppose FDA providing oversight of the integrity of private sector feed-based certification programs if they are requested to do so, we caution the agency to secure the necessary assurances so that its role is not misused to create winners or losers in the marketplace. Simply put, we do not believe a feed manufacturer's voluntary business decision on whether or not to participate in such a certification scheme should imply that its feed products are any safer or less safe than those who do not. The FDA also asked about the use of analytical tests capable of detecting mammalian protein in ruminant feed. The NGFA believes such tests should be employed by FDA as an enforcement tool only if they have been demonstrated to accurately, repeatedly differentiate between prohibited and non-prohibited mammalian material, including blood, milk and gelatin products, without resulting in false positives. Such tests also should also be compatible with existing FDA-approved equipment clean-out and sequencing 127 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 procedures that have been the hallmark of the medicated feed current for manufacturing practice regulations. To conclude our statement, I'll now ask Mr. Gottula to present our thoughts on operation-related questions posed by the FDA. MR. GOTTULA: Thank you. FDA asked several questions concerning whether it should amend its BSE prevention rule to require dedicated facilities or transportation equipment. The NGFA believes strongly that the decision of whether to utilize dedicated facilities to manufacture ruminant feed is a decision that should be made by individual companies based on the practicalities of doing so, given the types of feed they manufacture and customer preferences. In this regard the NGFA, as part of its BSE prevention policy, has recommended as a best management practice that feed mills that manufacture ruminant feeds voluntarily discontinue using prohibited mammalian protein unless they have separate and distinct mixing, handling and storage systems to prevent accidental commingling or cross- 128 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 contamination. It is our understanding that many feed manufacturers have made such a business decision, either because they believed it was the best way for them to comply with the FDA rule or because of preferences from customers or insurance carriers. But for some feed manufacturers, using dedicated plants or equipment may be impractical given the lines of feed they manufacture. For this reason we believe it would be inadvisable and costly for FDA to mandate such a requirement. The NGFA also does not believe FDA should require dedicated transportation equipment for hauling feed or feed ingredients containing prohibited mammalian protein. Doing so would increase delivery costs and disrupt operating efficiency, which, in fact, has occurred under just such a requirement imposed in South Dakota. The NGFA is taking proactive steps to address transportation-related issues associated with the FDA rule. Earlier this year the NGFA established an animal protein transportation task force, which I chair, that 129 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 has drafted a set of best management practices for transporting animal and plant protein in compliance with the FDA rule. The task force consists of representatives from the animal feed, rendering, rail and truck and soy processing industries. The draft best management practices which are under review by the task force identify procedures for using dedicated transportation fleets, customer-assigned equipment and clean procedures if hauling both prohibited and nonprofit mammalian material in the same conveyance. also cover loading and receiving procedures applicable to the transportation providers, plant and animal protein suppliers and the feed manufacturers. Once finalized later this year, They we'll be disseminating these procedures widely to companies within the relevant industries as well as through FDA and states and encourage that they be adopted. FDA also posed two questions on labeling. One asks whether the agency should require labels to identify the specific mammalian species from which the protein source was derived and the other asks whether to amend 130 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 the BSE caution statement to identify specific ruminant species that are banned from being fed products containing prohibited mammalian protein. The NGFA strongly opposes changing either of these labeling requirements. We believe that one of the strengths of the current rule is that the labeling and caution statements are well understood by feed manufacturers and feeder customers. Changing them could well create new confusion as well as result in excessive costs for the feed manufacturing industry as a result of the labeling changes with little offsetting benefit. Concerning the identification of species-specific mammalian protein on labels of all feed, the NGFA strongly supports use on feed labels of the "animal protein products" collective term as recognized by AAFCO. Collective terms are extremely useful and cost-effective for feed manufacturers because they allow various ingredient sources that have a similar function to be interchanged based upon these cost formulations, without having to change the list of individual ingredients that 131 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 are preprinted on feed bags or tags. The NGFA is unaware of any misuse of the "animal protein product" collective term that would justify a change to species-specific ingredient labeling. In terms of ensuring compliance with the BSE prevention rule, it is the presence or absence of the caution statement that feeders and feed manufacturers look for to determine if the feed is prohibited for ruminant species. We also have not seen how such a change would improve the efficiency of the inspection process, as inspectors still would be expected to review records to verify the source of animal or plant proteins being used in feed. If a customer requests such clarification, there are other less costly methods, including written and oral communication, to provide such information. We also believe that a requirement to change the caution statement to identify each type of ruminant is unnecessary and, again, would impose labeling costs on feed manufacturers and their customers. Commercial feeding of sheep, goats, bison, elk and deer are 132 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 relatively niche specialty markets whose feeders fully understand they are feeding ruminant animals. The NGFA appreciates the opportunity to provide its views on this important matter and pledges its continued efforts to achieve our mutual objective of keeping the United States free of BSE. Thank you. DR. LUMPKIN: of you. Are there any questions of either of these gentlemen? (No response.) DR. LUMPKIN: you. The next speaker is Mr. Ben Jones, who is a board member of AAFCO, the Association of American Feed Control Officials. Mr. Jones is with the Texas Feed and Fertilizer Control Service. MR. JONES: Dr. Lumpkin. I do currently serve on the board of directors for the Association of Thank you, All right. Thank Thank you to both 133 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 American Feed Control Officials. On behalf of AAFCO I wish to comment on the current rule, 21 Code of Federal Regulations Part 589.2000 to help prevent the establishment and amplification of BSE in the United States cattle herd. AAFCO is an international association with membership consisting largely of state and federal feed control officials responsible for administration of state laws, rules and portions of the U.S. Food and Drug cosmetic act pertaining to the distribution of commercial feed and feed ingredients for livestock, poultry and other animals, including pets. Currently all fifty states, Puerto Rico, Canada, Costa Rica, United States Department of Agriculture and the U.S. Food and Drug Administration are members of AAFCO. AAFCO recognizes that BSE is a serious health threat to ruminant animals in North America. BSE has had devastating effects in Europe on animal and human health as well as the livestock industries and economies of those countries. AAFCO is committed to achieving 134 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 100 percent compliance with the federal rule prohibiting the feeding of certain animal protein products to cattle and other ruminants. State members of our association have conducted approximately eighty percent of the inspections reported by the Food and Drug Administration since the adoption of the above regulations. AAFCO presents the following responses, specifically to the questions listed in the Federal Register: One, what additional enforcement activities, if any, regarding the present rule are needed to provide adequate public health control? We believe that to improve compliance with the rule, more frequent inspection and coordinated reinspection is recommended for the feed manufacturing sector. Inspection and compliance with the current rule should be expanded to include all industries. The agency must expand compliance inspections to the livestock producer level. This could be accomplished in the assistance and coordination of the state animal health officials. Border inspections need to be strengthened to prevent the importation of feeds or feed ingredients not 135 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 complying with the rule. Although it is important to continue to educate, it is time to start increasing enforcement activities. and federal application of enforcement activities using the AAFCO enforcement guidelines should be considered. Infraction State severity and associated regulatory action should be evaluated and applied consistently. 2. Is the present rule adequate to meet its intended objectives and are there additional objectives that this rule should now address? We believe that the current rule is a labeling and recordkeeping regulation. The agency should consider adopting good manufacturing practices that could encompass all of potential contaminants, including BSE agents, for all animal feed and feed ingredients. The rule should provide adequate guidance to all involved parties and accommodate other potential contaminants. T. Should the present FDA ban on the use of certain mammalian proteins in ruminant feed be broadened? AAFCO feels this is a science that -- requires a science-based response. Some of the current exclusions 136 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 deserve further scientific review. There is still considerable debate concerning blood products, plate wastes, tallow and poultry litter. 4. Should FDA require dedicated facilities for the production of animal feed containing mammalian protein? The intent and objectives of the rule are better achieved when dedicated facilities or dedicated mixing and conveyance equipment within the facilities are used. When a facility making ruminant feed does not handle prohibited material, the chance of commingling, contamination and accidental mixing or human errors are minimized. The above statement is based on our facility inspection experience. The current rule specifies that materials containing any amount of prohibited mammalian protein must be labeled with the cautionary statement. At this time it is difficult to assure that current flushing and sequencing procedures are adequate to eliminate with 100 percent certainty any amount of the BSE causative agents. We're not aware that the agency has established an 137 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 acceptable tolerance for prohibited protein in ruminant feed. The potential for accidental mixing warrants the consideration that ruminant feeds and ingredients intended for ruminant feeds be processed and assembled in a facility or by equipment within a facility dedicated to only handling nonprofit materials for ruminant feed production. This requirement is viewed as a positive step in preventing the occurrence and amplification of BSE in the United States. 5. Should the FDA require dedicated transportation of animal feed containing mammalian protein? We believe that requiring dedicated transportation of animal feed containing prohibited mammalian protein is viewed as another positive step in preventing the occurrence and amplification of BSE in the U.S. State feed regulatory agencies have very limited authority over the transportation system. The cleaning of transportation equipment between delivery of various commodities and feed ingredients appears to get limited attention at this time. Feed production facilities do advise sequencing loads of animal feed when 138 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 distributing within reason. In addition, the manufacturers flush their distribution equipment when sequencing is not possible. This could be a prohibitive, resource-intensive activity to observe and determine if distribution equipment was actually being cleaned to eliminate any amount of BSE causative agents. The agency should consider the development of GMPs for the transportation sector to provide regulatory authority, not only for the BSE issue, but also for all potential contaminants in animal feed. At a minimum, the agency should develop and mandate a validated clean method and recordkeeping system for the transportation industry to use. If feed manufacturers use dedicated facilities to manufacture ruminant feed, many of the trucks operated by the feed manufacturers will essentially become dedicated. However, trucks and rail cars used by the commercial transportation industry that haul many ingredients to the manufacturers may not be dedicated. Transportation providers, their equipment and employees may be difficult to find, educate and regulate and will require a coordinated effort with the federal Department 139 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of Transportation. 6. Should FDA require FDA licensing of renderers and other facilities engaged in the production of animal feed containing mammalian proteins? If the intent of a licensing requirement is to utilize the license as an enforcement tool subject to withdrawal of the license for violation of the rule and this additional enforcement tool will be used in a timely and appropriate manner, then we feel this issue may have merit. Without adequate regulatory tools and resources, the agency may provision. However, we are not aware of specific examples where this requirement would provide assurance for the prevention and amplification of BSE in the United States. Amendment of the rule to require FDA licensing of renderers and other facilities may not be necessary since most, if not all, firms are licensed by a state of federal agency. Many, if not most, of the states currently require licensing or facility -- registration of facilities engaged not be able to enforce this 140 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in the production of animal feeds. Many states also require licensing or permits for rendering establishments. It would appear that with continued cooperation between FDA and the states that these facilities are identified. However, if the FDA could identify renderers and feed facilities that are not currently licensed and inspected by a governmental agency with the BSE rule for compliance, we would support FDA licensing those firms. 7. Should FDA revoke or change any of the current exclusions for certain products allowed in the current rule? This As question requires a science-based response. previously mentioned, blood products, plate wastes, tallow and poultry litter deserve further scientific review. 8. Should FDA add to the list of prohibited material in ruminant feed, that being the term poultry litter and other recycled poultry waste products? Again, this question The concerns requires a science-based response. we have of poultry litter is not only the prohibited protein that goes through the digestive tract of the bird, but also the 141 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 unconsumed feed containing prohibited protein that is found in the latter through feed spillage. 9. Should FDA remove the exemption for pet foods from labeling with the precautionary statement? The exemption of the caution statement on pet food products can and does lead to confusion and misunderstanding in certain segments of the feed and feeding industry. This statement is made based on The first concern was in several concerns. regard to the use of salvaged pet food products. Broken bag product is being picked up from establishments handling pet products. This product is being further processed and may be used in other animal diets. Although much of this product is making its way into swine feed, on occasion there is some concern that product is being converted for distribution to ruminant animals. The second concern is in regard to the storage of packaged dry pet food at feed manufacturing establishments and on-farm. Animal producers, employees of the feed manufacturing establishments and purchasers of 142 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 animal feed have been educated to recognize protein material on the basis of the labeled caution statement. Since packaged pet food is not required to contain the caution statement established in the rule, there is concern that material from broken bags, leftover materials, or even intact pet food containers are not being recognized as prohibited material and could be incorporated into ruminant feed. In addition, pet food may be a source of imported animal proteins. Preferably the agency should reconsider the current exemption for pet food to be labeled with the caution statement. 10. Should FDA extend its present recordkeeping requirements beyond one year? At the current time, the one-year recordkeeping requirement appears to be adequate to do trace-forward and trace-back inspections. However, should there be a reported case of BSE in the United States, the one-year recordkeeping requirement may be inadequate to determine the source of the causative agent. 11. Should FDA change its rule to require labeling of protein-containing feed 143 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to specify what types of mammal was used in the production of the protein? We believe yes, requiring the listing of the type of mammal, along with the specific ingredient, would be of value in preventing the occurrence and amplification of BSE in the United States. This requirement would assist the purchaser to know clearly what ingredients and sources are contained in a feed ingredient or mixed feed product. The current use of the collective "animal protein products" also creates unclear situations and inadequate label information for the purchaser. 12. Should the required cautionary statement be changed to read "Do not feed to cattle, sheep, goats, bison, elk or deer?" We believe it should not read as such, but feel that in order to make the statement more clear and still be comprehensive, we suggest changing the cautionary statement to read, "Do not feed to cattle, sheep, goats, deer or other ruminants." This statement would list the common ruminants and would still leave it open to include other ruminants as well. 13. What new information is 144 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 available on potential efficient, accurate analytical methods that may be used in detecting mammalian proteins, and what should the sampling parameters of such a program be? comment at this time. AAFCO has no We think that is a question that will need to be addressed by the scientific community and experts that are currently working in this area. 14. Regarding enforcing compliance with the rule, what further authorities, if any, would be desirable in order to enforce the rule adequately? We believe that in general the states have adequate authorities available to enforce the rule. It appears that the agency could use additional enforcement authority and tools. We suggest that the agency may be interested in reviewing the AAFCO enforcement guidelines and craft their enforcement authorities to parallel those stated. Civil penalties and withdrawals from distribution should be considered for adoption at the federal level. 15. Regarding helping to increase compliance with the rule, what role, if any, should public or private certification 145 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 programs play? AAFCO believes that public agencies and private entities should continue to be a leader in providing education pertaining to the requirements of the rule to their members and the public. We do not believe that public or private certification programs should be utilized to judge compliance of a firm. Adequate state and federal resources are available to make a determination of a firm's compliance with the rule. State and federal inspection conclusions should be shared with inspected establishments to demonstrate that the establishment is operating within or outside of compliance with the rule. This will enable the industry the ability to provide the necessary assurances to their customers. Compliance with the rule is mandatory and should not be a component of a marketing program. 16. Regarding the import of feed, what should the restrictions on such import be? The restrictions should be country specific and a determination should be made that the country has in place restrictions that are equal to or greater than those in the United 146 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 States. And finally, are there any other additional measures that are necessary to guard against BSE and new variant CJD in the United States? We bode the question that if all state and federal feed regulatory agencies achieved 100 percent compliance from all sectors of the animal feed industry and allied industries and other involved federal agencies achieved their objectives to prevent BSE from occurring in the U.S., would this prevent the likelihood of an occurrence of BSE in this country? We know that TSEs are naturally occurring diseases in many animal species and are occurring in some populations, including our own. We must attempt to minimize the potential The intent of impact of an occurrence of BSE. the current BSE rule is to prevent the spread and amplification of the disease. The FDA must attempt to minimize the potential impact of an occurrence of BSE on the agricultural community and consuming public. The agency and states must have an enforcement rule and provide adequate resources to enforce it. Reaction to mishaps 147 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 that have already occurred must be dealt with; however, proactive approaches must be reviewed and then implemented. Enforcement tools must be in place and used at the federal level that are of significant consequences to the parties involved which are not in compliance with the rule. The agency should encourage and support all state feed control officials to incorporate a BSE inspection component into their routine feed inspection programs. The results of those state inspections should be shared with FDA to be entered into a national database tracking compliance with the BSE rule. On behalf of the Association of American Feed Control Officials, I would thank the Food and Drug Administration for the opportunity to provide these comments. DR. LUMPKIN: Thank you, Mr. Jones. Any questions? (No response.) DR. LUMPKIN: Thanks again. Our next speaker is Randall Gordon. Mr. Gordon is the vice president of 148 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 communications and government relations for the National Grain and Feed Association. My understanding is that he's been authorized by the Pet Food Institute to speak on their behalf at this time, and he will be doing that and not speaking on behalf of the NGFA. MR. GORDON: Lumpkin. I am speaking today on behalf of the Pet Food Institute, the trade association that represents the manufacturers of 95 percent of the dog and cat food sold in the United States. The Pet Food Institute was unable to have a representative here today because it is conducting its annual board of directors and annual industry meeting in Chicago. The National Grain and Feed Association and Pet Food Institute have developed a strategic alliance to work together on issues of mutual interest between our different industries. It is under that Thank you, Dr. arrangement that I offer the following comments on behalf of the Pet Food Institute in response 149 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to the agency's questions that are under consideration here today. The Pet Food Institute and pet food industry has and continues to support the government's efforts to prevent the introduction of BSE into the United States and the safeguards that are currently in place. We agree that the need for a cautionary statement on pet food sold at retail has already been addressed by the agency in its 1997 rule-making and does not need to be considered again. In January 1997, the FDA proposed a cautionary label on pet food sold at the retail level as part of its efforts to prevent the amplification of the BSE disease-causing agent, should it ever be found in the United States. FDA, in its final Federal Register notice later that year, agreed that a label on pet food sold at retail was not needed. The agency noted, quote, "FDA agrees that the cautionary statement serves no useful purpose on pet food. .These products typically cost substantially more per ton than most complete feeds intended for food-producing animals. Therefore, there is little, if any, risk that 150 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 pet foods...will be purchased at full price for use in ruminant rations," unquote. As was the case in 1997, under a cautionary labeling scheme, pet foods would be the only retail products to carry a precautionary statement on the label. As the research conducted by the Pet Food Institute previously presented to the FDA indicated, such a label would not only have a negative effect on pet food by unnecessarily alarming consumers, it would also have a negative impact on human foods. PFI's research has found that 71 percent of consumers would buy something else if they saw such a label on pet food; 68 percent would be very concerned about the safety of the pet food if it carried such a label; and 40 percent of the respondents would be very concerned about consuming beef and lamb because of the label on pet food products sold at retail. Since, as the agency correctly points out, dog and cat food sold at retail is neither designed nor priced to serve as ruminant feed, the necessity for such a label at the retail level is further decreased. Salvage and distressed pet food, as is currently required, 151 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 should continue to carry the label "Do not feed to cattle or other ruminants," and the industry recognizes its responsibility to ensure such materials are handled in compliance with the regulation when used in animal feed. The Pet Food Institute has taken a number of steps to remind its members, other organizations and state government officials of the importance of complying with the salvage and distressed pet food labeling requirements and will continue its efforts to prevent these products from being included in ruminant feed. PFI believes the proper enforcement of the current labeling regulation is the best method to prevent the inclusion of salvage and distressed pet food in ruminant feed. In conclusion, the Pet Food Institute, on behalf of its member companies, believes the agency was correct in 1997 that a cautionary statement on retail pet food products was not necessary. The efforts to prevent BSE from entering the United States have been successful since 1997 in the rule that was issued. A cautionary statement on pet food 152 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 products is not warranted and the current regulation should not be amended. Thank you. DR. LUMPKIN: Thank you. Are there questions? DR. SUNDLOF: DR. LUMPKIN: DR. SUNDLOF: Yes. Steven. Randy, it says Is here in the PFI statement, numbered steps. there official guidance out for that? MR. GORDON: Steve, I am going to have PFI respond to this in writing, if you don't mind. They have had some communication with some of the dairy industry and some of the state directors of agriculture on this issue, and I think I can ask them to make that available and respond to that question. DR. SUNDLOFF: The other thing, the research is that a 71 percent of consumers would buy something else if that was on the label. What's "something else"? MR. GORDON: Again, if I could, I'll ask them to respond in writing to that. DR. LUMPKIN: Thank you again. Our next speaker is Brad 153 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Gottula, director of quality assurance, Land O' Lakes Farmland Feed in Fort Dodge, Iowa. will be speaking on his own behalf at this point. MR. GOTTULA: Thank you. He As was mentioned, I'm the director of quality assurance and regulatory affairs for Land O' Lakes Farmland Feed. Our company operates 95 feed manufacturing plants in 29 states in the U.S. and in the province of Ontario, Canada. In addition, our grain and feed products are manufactured at over 200 locally owned cooperatives in North America. Our company supports the efforts by the FDA and other governmental agencies to prevent BSE from ever becoming a threat in this country. We appreciate the opportunity to respond and give our insight to several of the thought-provoking questions that are the focus of this important hearing. In regards to Question 1, what additional enforcement activities, if any, are needed regarding the present rule to improve public health controls and what suggestions would those be? We do not believe additional 154 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 enforcement tools or measures are needed to enforce 21 CFR 589.2000 that ultimately would provide improved safety and public health. overall educational efforts that have been ongoing for the last four years need to remain a primary focus in order to make sure all feed manufacturers and animal producers are adequately informed and educated about this important rule. One of the biggest areas of confusion or inadequacy that is existent with this rule is that some feeders, small feed dealerships and non-FDA licensed feed manufacturers to not seem to understand all the rule requirements and exemptions. This The ultimately leads to noncompliance issues and misinformation as well as confusion in the marketplace. Continued efforts to educate all entities that are the subject of this rule must be undertaken to improve understanding and compliance. An approach of using targeted inspections of firms who have not consistently proven to be adequately informed and in compliance or of those firms who are actually rendering or using prohibited mammalian proteins 155 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 may be an effective method to improve compliance with the requirements of this rule. In regards to Question 3, Should the present FDA ban on the use of certain mammalian proteins in ruminant feed be broadened? The present rule that bans the use of certain mammalian proteins in ruminant feed should only be broadened if compelling scientific evidence supports the fact that an ingredient or product may be a carrier of the BSE agent. Banning products based on anything other than scientific evidence leaves the feed industry and our customers prey to the emotion and speculation that ultimately damages the credibility of our nation's animal feed and food supply. Suggestions to ban approved feed ingredients such as blood products, gelatin and milk products should be halted as scientific evidence from extensive studies done in Europe in the past by the World Health Organization as recently as mid to late '90s have proven that blood products do not carry the BSE agent. Any revocation of an exemption or excluded product currently allowed under 21 CFR 589.2000 should and must be based on sound science. If 156 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 compelling scientific evidence does not prove a product is a carrier of the BSE agent, it should be allowed or continued to be allowed as an approved feed ingredient for specific species of animals. Question 4, Should the FDA require dedicated facilities for the production of animal feed containing mammalian protein to decrease as much as possible the possibility of commingling during production? Many feed companies, including Land O' Lakes, Farmland and Purina Mills have voluntarily made this decision either soon after the publication of the rule in 1997 or more recently. The voluntary stance many companies have adopted and Land O' Lakes Farmland Feed supports regarding not manufacturing ruminant feeds in facilities that utilize prohibited mammalian proteins or to simply not utilize prohibited mammalian proteins in their feed mills is working, and there is little added benefit foreseen in making this a mandatory requirement with the absence of BSE in this country. Regarding Question 5, Should FDA require dedicated transportation of animal 157 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 feed containing mammalian protein to decrease as much as possible the possibility of commingling? From an efficiency standpoint, this will increase delivery costs and the operational challenges to effectively transport feed and feed ingredients. The recent enactment in South Dakota of specific transportation and handing regulations for delivery vehicles transporting ruminant feeds and feeds that may contain mammalian proteins will increase the costs for feed manufacturers, dealers and customers because it is removing transportation efficiencies that feed manufacturers have utilized in a safe and efficient manner for many years. Today in South Dakota two delivery vehicles may now be required to deliver a feed shipment depending on the type of feed that, in the past, was usually taken care of by one vehicle. At $1.40 per gallon for fuel for delivery vehicles that typically average six to seven miles per gallon, this is very expensive for feed manufacturers and haulers, and these costs will be passed on to customers. 158 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 In the case of prohibited mammalian protein ingredients that are delivered to feed manufacturing sites, we believe there may be some inherent benefit in having dedicated trailers and rail cars for these products, as this will likely reduce cross-contamination issues. However, additional costs will be incurred and likely passed on to manufacturers, dealers and customers. Regards to Question 11, Should FDA change its rule requiring labeling of protein-containing feed to specify what types of mammal was used in the production of the protein? AAFCO has utilized and the FDA has endorsed the use of the collective feed term concept in 35 states since the early 1970s. concept is based on the sound nutritional principle that animals do not require any specific feed ingredient but need nutrients that can be provided by a wide range of ingredients. The benefits of these terms are many, but primarily result in lower cost to the producer/customer without any sacrifice in safety or nutrition. No other labeling concept The has been nearly so successful in the feed 159 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 industry. Of the seven collective terms acting legally as definitions on feed labels, the one with the most concern is "animal protein products." In 1998 AAFCO asterisked all the feed definitions within this term which are prohibited/restricted in ruminant feeds as per 21 CFR 289.2000. The feed industry strongly supported this effort. FDA requires firms to place the caution statement, "Do not feed to cattle or other ruminants" on any label or label containing or likely to contain any substances prohibited in ruminant feed. This statement is the sole indicator that if feed is likely to contain a restricted-use protein product from the list of asterisked products in the AAFCO and protein product collective term. If a firm does not use the cautionary statement, it indicates that the feed does not contain restricted food products. Some regulatory officials believe that doing away with the "animal protein products" collective term would simplify regulatory obligations. This view is not 160 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 necessarily correct, as verification of the ingredients actually used in a feed formula requires review of formula records, regardless of whether a collective term is used. For example, if a firm were to use the term "meat and bone meal" only on a label without the collective term, verification would still be required in order to document the actual ingredient used is indeed the one on the label. If AAFCO or FDA were to change the protein ingredient names to require species names, as is already voluntarily allowed, the names can be porcine or pork meat and bone meal and bovine or beef meat and bone meal. If a firm chooses to use one of these names on a label with or without the cautionary statement, investigators would still be required to examine formulas and ingredient records to verify if, in fact, the correct product and ingredient name were used. Any changes made to collective term or ingredient listings on feed labels must be based on a sound understanding that the changes will result in better compliance, better regulation or better prevention of BSE. Moreover, a review of the inspection data 161 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 collected by FDA should clearly reveal that either there is widespread abuse of the term or serious misbranding to justify changing these ingredient names. exist at this time. Regulatory changes regarding use of collective feed labeling terms will result in substantial costs to change feed labels, and feed manufacturers and regulatory agencies must justify the costs for any benefits derived. Regulatory changes regarding changes That justification does not in accepted feed labeling practices moves our industry further from having uniform feed labeling guidelines across state lines and further hampers effective and efficient business practices, as mentioned earlier with the example in South Dakota and the additional regulations they have not implemented regarding feed labeling, handling and transportation. As the U.S. does not have BSE, it is difficult to justify this major change to feed labeling regulations. In regards to Question 12, In order to make the statement clearer, should the required cautionary statement on the label of 162 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 products that contain protein derived from mammalian tissues and that are intended for use in animal feed be changed to read, "Do not feed to cattle, sheep, goats, bison, elk or deer."? We do not believe changes are needed in the caution statement, as the statement is adequate to communicate the intended information, provided people using the product look for the statement and read and follow the product label. A change in the caution statement wording would be quite costly to the feed industry, and would provide little, if any, added benefit to the feed customer and consumer who ultimately must pay for these changes. In regards to Question 15, regarding helping to increase compliance with the rule, What role, if any, should public or private certification programs play? Certification programs can exist in a variety of forms. Affidavits and self-certification forms are and should be widely accepted, as many companies are in compliance with this rule and have excellent documentation, and their quality assurance and regulatory programs that prove this. FDA has recently updated their BSE 163 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 inspection form to include an inspection finding summary section in which, when the inspection finding or inspection report is eventually shared with the firm that's been inspected, compliance or noncompliance with the BSE rule is documented. This should be ample proof to any feed customer or livestock buyer that the firm in question is in compliance with 21 CFR 589.2000. Fee-based third-party certification programs may be of interest to some companies, but our view is that FDA must be cautious in whether or not it endorses such certification programs as this may open the door to unfair competition in the marketplace by companies who would possibly leverage livestock buyers and food companies to only purchase animals fed by third-party certified feed manufacturers. firm belief is that state and federal BSE inspection programs are working and should continue to be the compliance indicator for the regulated industry. Funding should continue to Our be directed toward this end. Land O' Lakes Farmland Feed appreciates the opportunity to share our views on this important feed regulation. We have 164 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 worked diligently to inform our employees and customers of this rule's requirements and pledge to continue to do all we can to prevent BSE from threatening our nation's feed and food supply. We would like to commend the FDA for its scientific view of this important issue and urge that they continue to foster open dialogue and reason regarding this rule as it is evaluated as to its effectiveness. DR. LUMPKIN: Mr. Gottula. Thank you. Any other questions? (No response.) DR. LUMPKIN: Thank you, sir. I'd like to ask now Mr. Mark Hohnbaum to come to the podium. Mr. Hohnbaum is with H.J. Baker & Brother, Inc., in Little Rock, Arkansas. MR. HOHNBAUM: My name is Mark Hohnbaum, and I am the representative of H.J. Baker & Brother, Inc. H.J. Baker & Brother has served the feed food industries for 151 years. One of our largest businesses is animal and marine protein formulate. We have four domestic plants for this application. As one of the largest consumers 165 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 of rendered animal proteins in the United States, we have a unique perspective on the rendering industry. We purchase material that runs the gamut from fish to fowl and beef to pork. Our suppliers range in scale from the fully integrated multi-nationals to the mid-size independent renderers and finally down to the tiny one-plant operators. From this view some things are apparent that may not be obvious from the outside looking in. Education about what our industry really is started more than thirty years ago with an isolated few. It has accelerated through the past five years to a point where all rendering industry employees now know we are in the food business. This understanding lends a certain gravity to all activities undertaken. In the late 1980s, when the first reports of a causal link between meat and bone meal from scrapie-infected sheep being fed to cattle was postulated as the source of BSE, our company, with the majority of U.S. rendering and feed industry companies, voluntarily removed 166 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 this risk material from our plants. amazing variety in this industry. We see But we see total unanimity in the knowledge that total compliance and complete adherence to feed ban rule is vital to public health and our industry's future. This is a responsive and responsible industry manned by smart people. not only see the fruits of our labor but sit down at mealtime with our families and consume its ultimate products. We value food safety. We We also value valid science. The best science today suggests that TSEs are a complex and vexing category of diseases. However, working from today's generally accepted postulates, the transmission agent is prion. This prion from the sheep with scrapie infected cattle in the U.S. and started the BSE epidemic that they are fighting today. Many factors that were present in the U.K. beef food industry in the early 1980s have been and are dramatically different here in the U.S. High versus low sheep/cattle ratio, low versus high temperature rendering systems, high versus low cattle herd age, and high versus low -- now no -- 167 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ruminant-derived protein in ruminant feed rations. These obvious differences could go a long way toward explaining why the disease didn't spontaneously generate here. When coupled with the USDA's ban on imported cattle from suspect countries and subsequent bans on meat and bone meal from these same countries, then our risk at that time was very, very low. Add to these factors FDA-CVM's well conceived and comprehensive rule based on the best science available, coupled with strict enforcement, and it has reduced the risk to the limits of detectability. Safeguards are in place and working. FDA-CVM's mandate to protect human/animal health has been well served by this regulation. Reopening the rule would increase Let the public anxiety, not public safety. regulation stand. Do not reopen the rule. Thank you very much. DR. LUMPKIN: Thank you, sir. Any questions. (No response.) DR. LUMPKIN: Thank you again. I'd like to now call on 168 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Mr. Michael Malecha, who is president of AG Innovations in Madison, Wisconsin. MR. MALECHA: Dr. Lumpkin. Thank you, I'm Mike Malecha, and I am president of AG Innovations in Madison, Wisconsin. As consultants to the food, feed and industrial agricultural industry, our main focus is to work with client companies to effectively manage their co-products to greater value, both economically and environmentally. Maintaining feed and food safety is paramount in the fulfillment of our responsibilities. As an active member of the feed industry, I currently serve on the board of directors, chair the feed trade rule subcommittee and serve on the feed and industry committee of the National Grain and Feed Association. I recently served as a member of During the liquid feed committee of the AFIA. my 26 years in the food and feed industry, I most recently spent eleven years at Kraft foods North America as manager of by-products and feed ingredients, and prior to that for nearly ten years at Ralston Purina Company managing feed 169 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 ingredient purchasing in their pet food and grain divisions. To start out, it's important to reiterate: There's not been a single case of Due to BSE found in the United States today. active surveillance by the FDA and USDA and strong industry support by feed manufacturers, livestock producers, meat processors, transportation industry, food manufacturers and purveyors, veterinarians and trade groups, the science-based regulations currently in force have facilitated the goal of keeping BSE from entering our country. The FDA should be commended for their leadership in preventing BSE, and for being the linchpin in the protection of our food and feed supply. The establishment and enforcement of the three firewalls has provided a sound strategy in that effort. We strongly believe that the FDA must continue to base its position on sound science as we move forward. As new scientific information is confirmed, the strategy should be adjusted to accommodate it. It is vitally important that FDA maintains its high standards 170 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 and its reputation as the lead agency in food safety in the United States and in the entire world. Because of that leadership and the support of the entire food industry, the public will continue to enjoy the safest food supply available. To continue in those efforts I recommend that the FDA should maintain the program of direct inspection by providing the necessary resources and enlisting the support of the state feed control agencies to inspect meat facilities and transportation concerns. regulatory task can be accomplished. The It is our view that affidavits of compliance and bona fide third-party inspections as APPI has undertaken are effective measures as long as there's definite periodic inspection by the FDA or their state counterparts. To endorse or recommend certification by not-so-independent arms or organizations as a means to reduce FDA inspections would undermine the confidence and support of the food industry and the public at large and would damage the reputation of the FDA that it currently enjoys. These latter certifications, while certainly providing augmentation to company best practices, are 171 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 viewed by much of the food industry as not independent enough and as possibly anti-competitive due to their nature when foods produced from these products may be certified as beneficial and superior. We stand behind the A strong FDA and the BSE prevention effort. science-based FDA adds credibility to the food and feed industry in the global economy as well. To improve compliance with the rule we'd recommend that the FDA and state agencies forge a strong inspection and compliance program that is driven by a tracking system from the initial source to an ultimate user. By using a trace-forward approach, a targeted inspection program can be implemented in an effective and efficient manner to best deliver the necessary feed safety. It is vitally important that adequate funding be provided by congress to carry out the strategies to meet full compliance with the rule. Regarding the present rule and its objective, we believe the current rule is satisfactory as written. The issue of dedicated facilities should be left to the individual 172 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 companies to decide based on their ability to manage the process. As a recommended best practice, separate facilities or fully separate systems would be preferred; but the ultimate decision should left to the individual business. To require separate facilities would be anti-competitive and could be financially detrimental to some concerns. The transportation method should be left up to the shipper and receiver to decide, provided best management practices are employed to comply with the rule. To restrict shipment to dedicated conveyances would be extremely costly and lead to unnecessary overcapacity and/or significant delays in service. We do not believe that the FDA should change or revoke any of the exclusions to the current rule, nor should the agency add to the list of prohibited materials unless there is compelling science-based evidence to do so. Unless new scientific evidence is available, the feeding of plate waste, which includes previously USDA-inspected cooked meats, should continue. Reverting that product to landfill or 173 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 other destruction would add to groundwater issues or things that are governed by EPA and increase cost to the restaurant and food industry. Unless science supports the addition of dairy or gelatin to the prohibited list, we do not support that for convenience, as it would send a negative message to consumers who regularly purchase those foods for their own use. We would recommend that FDA continue to exempt pet foods from labeling in the precautionary statement. Salvage pet food should be properly noted with a precautionary statement on the shipping documents, however. Present use of mammalian feeds where packaging is destroyed in the process, and having it on the label would add no value. I want to thank the FDA today for scheduling this hearing and for the opportunity to provide these remarks. DR. LUMPKIN: much. Are there any questions of Mr. Malecha? Thank you very 174 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 I have one question, and perhaps it's a bit rhetorical. I thought it was interesting, you made the point that you had a concern that if certain products were now said to be unable to be used in animal feed, that that might have a negative effect on consumers because they would misinterpret this. MR. MALECHA: DR. LUMPKIN: Yes, sir. Is there any other evidence that that happened when the original ban went into effect and we said you can't feed beef to cattle? Did that have a negative effect on the consumers' view that beef was safe in this country? MR. MALECHA: I'm not sure we saw a measured response to that very specifically. What happened in the biotech area in relation to -- well, not only organic but any biotech concerns in products and the relationship is pretty close, especially as we've seen in the press and everything else. Bringing other diseases and linking them with BSE, we see that that potential does exist. Also it's subject, obviously, to mismarketing, and you're never totally safe 175 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 in that process. DR. LUMPKIN: Thank you, sir. Our last speaker before the afternoon break is Steven Roach with the Food Animal Concerns Trust out of Chicago, Illinois. MR. ROACH: Yes. I would like Fair enough. to thank the FDA for providing us the opportunity to present these comments. Food Animal Concerns Trust is a nonprofit organization that advocates better farming practices to improve the safety of meat, milk and eggs. FACT was at the table when the federal strategy to keep U.S. cattle free from bovine spongiform encephalopathy, BSE, was fashioned several years ago, and FACT worked on the drafting of the FDA rule to prohibit certain types of mammalian protein from ruminant feed, which we are reexamining today. FACT's position on BSE is based on an awareness of the real risks of transmissible spongiform encephalopathies, TSEs, to human and animal health, combined with an acute sensitivity to the current scientific uncertainties on how this class of diseases is transmitted both within and 176 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 between species. FDA has requested public comments on several aspects of the existing role to limit the spread of BSE through the regulation of animal feed. FACT commends the FDA for the work they have done so far in creating the original role and enforcing its provisions, but we feel that the time is right for a re-evaluation of the regulation. Since 1997 we have seen the disease spread throughout Europe, and it has now been found in Asia. The profile of the disease in Europe indicates how easily the disease can spread when controls on feeding are not stringently enforced. So the evidence in Europe is that they did have effective rules and regulations, but that enforcement of the regulations failed, and that's why they've been getting more new cases. So what it looked like in Europe happened was we had the disease got to a country, and then the people started enforcing the regulations, and we fear there's a risk of that scenario happening here as well. The unexpected appearance of BSE in Japan suggests that other countries outside of Europe may have 177 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 undetected cases, and there is a real risk that feedstuffs containing the disease or the affected material will be imported into the U.S. It is important to note that we did not have restrictions on importing feed from Japan during the period when the disease was present but undetected. And I wasn't able to get the exact figures on it, but I think in the last year we imported 10,000 metric tons of feed from Japan. So's not a lot of feed, but it is some. And it's not clear how much of that might have had meat and bone meal in it. Because BSE is currently developing into a worldwide problem, spreading from its appearance in a single nation, the United Kingdom, FACT calls on the FDA to broaden the scope of the FDA ban and to more rigorously enforce the current provisions. I will now discuss the questions on which the FDA has requested comments. For Question No. 1, FDA needs to respond quickly to operations that are out of compliance with the rule. In a recent report provided by the FDA's Center for Veterinary 178 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Medicine, CVM, over 500 businesses were found to be out of compliance. Almost 400 of these firms that were out of compliance handled both ruminant and nonruminant feed. Perhaps even more disturbing is the fact ten firms that handle both ruminant and non-ruminant feeds met none of the requirements of the rule and have not been reinspected since the end of 1998. We accept that the compliance inspection process is an arduous task, but here we have a clear case of rule violations with no follow-up in over two years. According to the rule, these businesses are clearly in violation of the Act and are marketing the illegally adulterated animal feed. If after a prompt follow-up inspection the business is still not in compliance with the law, the FDA should use its authority to confiscate and condemn any illegally adulterated feed. This would obviously include any feed intended for sale as ruminant feed by the out-of-compliance entity. Okay. For Question No. 2. FACT believes that the current rule is too narrow in its scope and focus. The aim of the rule should be expanded to reduce potential 179 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 amplification of all TSEs and not focus so narrowly on BSE. The first way in which it should be modified is that there are too many exclusions on the types of protein that are regulated. The second area where the rule fails is that it does not sufficiently address the potential for the transmission across species barriers. These two failures will be addressed below in response to Question 3. Okay. So Question 3. TSEs have been found to affect humans, goats, sheep, mink, deer, elk, cattle, domestic and wild cats, zoo ruminants and zoo primates. Experimentally, TSEs have been transmitted to mice, and it has also has been transmitted experiment to swine. The transmissible agent for all TSEs is believed to be an altered form of naturally occurring protein -- prion -- that builds up in central nervous tissue, leading to neurological disorder and death. In addition to being found in the central nervous system, the transmissible agent is also found in the lymphatic tissue, intestines and blood. For each of the known 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 TSEs, as FACT understands it, there is still uncertainty about how the infectious agent is transmitted and about how the disease develops during incubation. When interspecies transmission is included, the picture becomes even murkier. In the case of BSE, there is evidence of transfer between cattle and many other species, including felines, ruminants and humans. And in these cases, this is natural transfer through the world and not an experimental route. While it is clear that there exit barriers to the transmissions of TSEs between species, the nature of these barriers is little understood. Therefore, FACT urges the FDA to limit the exclusion on mammalian proteins allowed for feeding to ruminants to milk and milk products and to products made exclusively of horse and/or equine protein. The current exclusion of blood products is unacceptable, given the clear evidence of infectivity in blood. Similarly, there is no justifiable reason to exclude food offered for human consumption, such as plate waste. This is 181 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 particularly important given the potential for unspecified material of foreign origin in plate waste such as was implicated in the outbreak of foot-and-mouth disease in the United Kingdom. Because of the continuing evidence regarding the potential to transfer TSEs between species, FACT recommends that the FDA review whether or not restrictions should be replaced on any animals with neurologic disorders as feed for any livestock, including poultry, equines and swine. The use of materials from bovine central nervous system should be banned, along with the use of bovine materials from any countries with a high risk for BSE for any animal feeding purposes. In relation to Questions 4 and 5 on dedicated facilities or dedicated transportation, FACT believes that dedicated transportation and facilities are important, given the very difficult task it would be to enforce compliance or have inspection, on a daily basis, of facilities. So you may come once a year and look at the facilities and they clean out very well; but cleaning out on a day-to-day basis is going to be something that 182 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 there will always be -- hides enough to cut corners on that. So one way to get around that strong incentive to cut corners on clean-out is to just have dedicated facilities. Okay. For Question 6. Where FDA does not currently license feed preparation, licensing other establishments would be an excellent tool for increasing compliance with the rule. If it is not feasible to license all facilities, a subset of facilities could be licensed. Facilities that produce feed for ruminants could be licensed, or facilities that handle both ruminant and non-ruminant feeds could be licensed. Licensing would need to be combined with enforcement to make it an effective tool. Licensing combined with monitoring using analytical methods that distinguish between prohibited and non-prohibited materials could provide a much higher level of compliance than our current system with its less than annual checks. I'll skip down to Question 10. Should FDA extend its present recordkeeping? Records should be kept for a minimum of five years. FACT pushed for this provision when the 183 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 rule was first considered, and FACT still believes it is an important provision. Because the incubation period for BSE is four to five years, FACT urges FDA to require that records be kept for a minimum five years, providing the information necessary to trace the source of infection in case of an outbreak. I am going to skip to Question 14. Regarding enforcing compliance with the rule, what further authorities, if any, would be desirable? FDA should use its existing authority to condemn adulterated product as defined in the rule in the case of repeated consistent noncompliance. FDA should seek to extend its authority to investigate potential violations that occur where feed is mixed on-farm. So FACT is concerned that there may be mixing of ruminant proteins back on-farm that's not inspected or monitored in any way whatsoever. So we think there needs to be some system to look at what's actually occurring on-farm. Regarding public and private certification programs, our position basically is that certification programs are fine as 184 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 educational tools and to help businesses develop their internal control systems, but they should not be used by the FDA as a justification for lessening its own compliance monitoring program. On the importers of feed, FACT urges the FDA to follow the official International Des Epizooties standards and conduct risk assessments on individual countries. Given the risk of importing BSE infected feed into the U.S., imported feed containing animal proteins should not be used in feeding ruminants unless the country of origin has demonstrated effective rules for the segregation and labeling of feed that are equivalent to U.S. rules. So at this point, since we don't have those risk assessments done, I think we should be real cautious about any imported feed for ruminants in the U.S. a job that needs to be done. Okay. Are there any other FACT believes That's additional measures necessary? that much more work needs to be carried out on basic research on BSE and other TSEs. One area that is absolutely essential is the development of a diagnostic test that can be used on live 185 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 animals. More research also needs to be done on the nature of the species barriers between the different TSEs. Right now we don't see any evidence of there being a risk for a swine, but I think that's something that we need to constantly, in our minds, be alert for. We have to remember that before BSE we didn't think there was risk in bovines. Things change, so we need to be very alert and careful. In summary, FACT urges FDA to continue its current efforts to control the potential spread and amplification of BSE. In addition, FACT calls on FDA to strengthen its efforts by broadening the range of prohibited products to include all ruminant proteins and by taking further precautions with the most at-risk materials, such as proteins from animals with neurological disorders. In the area of monitoring of compliance, FDA needs to step up reinspection of noncompliant firms and, if necessary, to use its authority to condemn feed that is adulterated by definition of the rule. And again, I'd like to thank FDA for providing us the opportunity to present 186 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 these comments. DR. LUMPKIN: Thank you, Mr. Roach. Are there any questions from the panel? I wasn't sure if you said this. I apologize for having missed it. But does FACT You have any views on the poultry litter issue? talked about some of the exclusions. sure. MR. ROACH: concern there. I wasn't Yes, we do have a I mean, our organization does not believe that feeding litter is a good idea for other issues. We think there's a big BSEs, problem with the drugs that pass through. we do think there's a risk, particularly from spilled feed; but we think that there's the other issues in terms of the feeding of blood meal, and that is a much higher priority for our organization. DR. LUMPKIN: clarifying that. We have now reached the point in our agenda where we're supposed to have a break until 3:00 when we will begin the time for Thanks for 187 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 individuals who did not register to talk. aware of one individual who has expressed a desire to present to the panel, so I will recognize that person at 3:00. I'm If there are others who are in the audience who wish to speak, obviously they will be given an opportunity following that individual. So I will say, let's go for a break, and we will reconvene at 3:00. very much. (A recess was taken.) DR. LUMPKIN: It's a little Thanks after 3:00, and to be fair to people who were given time to talk, I would like to call us back into session, please. Before we get started, I would simply like to point out for the record that Dr. Dan Machesney has joined the panel as the representative of the Center for Veterinary Medicine at FDA. Dr. Sundlof had to return to Washington early this afternoon and had to leave. As I mentioned before we took our break, this is the time in the program that it's been dedicated for testimony from other 188 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 interested parties who did not register to speak earlier today. I'm aware of one individual and I'll call on that person now. Chuck Massengill from the National Cattlemen's Association. MR. MASSENGILL: I'm Chuck Massengill, a cattle producer from California, Missouri. I'm on the National Cattlemen's Beef Association, cattle health and well being committee. I want to thank the agency for the We will have opportunity to respond verbally. detailed written response addressing each individual item which will come prior to the November 21st deadline. much. We asked for this time -- the Cattleman's Beef Association asked for this time to respond. We want to provide a very short Thank you all very response, but we wanted to clearly reiterate the basic position of the National Cattlemen's Beef Association is that we feel that the rule as it currently exists, with enforcement, is adequate to continue to achieve the goal of preventing the establishment and amplification of BSE in the United States. We feel that any changes in 189 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 this rule must be science-based, they must be well documented, they must be well researched. As so many people have repeated, there is so much -- there are so many people with so much at stake that it's just absolutely crucial that it be a science-based program and continue that way. We see BSE as a foreign animal disease. It's certainly one of several foreign We feel animal diseases that causes concern. specifically if the disease status of a country is in question, we should stop trade with that country and then ask questions and determine what the actual risk is. We don't feel that we should tarry in our decision to protect our economy and our animal industry. We encourage the agency to continue to support research on means to exclude BSE from the U.S. That concludes my short comments, sir. DR. LUMPKIN: much. Are there any questions for Mr. Massengill? Thank you very 190 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 to clarify that. is he here? (No response.) THE COURT REPORTER: Excuse me. Would you spell your name for me, please? MR. MASSENGILL: M-a-s-s-e-n-g-i-l-l. DR. LUMPKIN: The question was, just for the record, for Mr. Massengill to spell his name, since we didn't have it in writing for the record. I know there was some confusion apparently earlier this morning about a comment one of the speakers made, and so I will ask Dr. Solomon to raise that question and the speaker, my understanding is, will answer it. DR. SOLOMON: Richard Sellers, The question that came up with the comments you made about a submission of a partnership agreement to the agency and whether -- there was some confusion about the status of that. If you'd clear that up. MR. SELLERS: Sure, I'm happy Yesterday we filed our partnership agreement, and unless the acting commissioner signed it yesterday, it's not been 191 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 signed. It's a draft, and we expect to have So it was filed yesterday. It was a some negotiations. DR. SOLOMON: petition, or how was that -MR. SELLERS: It was a draft partnership agreement with a letter accompanying it asking the agency's participation. DR. LUMPKIN: Thank you. Is there anyone else at this time who would like to speak before the panel who did not register to do so? (No response.) DR. LUMPKIN: twice. As I mentioned this morning, in the Federal Register notice that announced this meeting, we announced that the hour between four and five would be held for public testimony if people did not register to do so and wished to do it. Under our rules of engagement, we indeed Going once, going have to be here at the beginning of that hour in case someone looked at that in the register and said "Oh, I need to be there at four in order to say what I wanted to say before the panel." what I will do now is spend this meeting from So 192 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 now until four. We will reconvene at four to check to see if, indeed, anyone is available, anyone who wanted to talk at the appointed hour in the FR notice. If there is no one here at four, I will conclude the meeting at that point. So for right now the meeting is suspended and we'll reconvene at four to make that check. (A recess was taken.) DR. LUMPKIN: Ladies and I'm calling gentlemen, it's 4:00 by my watch. this hearing back into session. The purpose of the hearing at this point is to ask if there are any others who did not register this morning who would like to make comments before the panel. please come forward now. (No response.) DR. LUMPKIN: Going twice. Sold. Okay. Thank you. Going once. If they do, Before we close, I would like to again thank our colleagues here in Kansas City for the wonderful work they did to make 193 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 this happen, to thank all of you who are still here and have stayed with us all day and those who chose to leave earlier for their comments. With that, I declare this Part 15 hearing closed. home. (The proceedings concluded at 4:03 p.m.) Everybody have a safe trip 194 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 C E R T I F I C A T E I, LINDA R. BURT, a Certified Shorthand Reporter of the State of Kansas, do hereby certify: That said foregoing testimony was taken down by me in shorthand at the time and place hereinbefore stated and was thereafter reduced to typewriting under my direction; That the foregoing transcript is a true record of the testimony given by said witness; That I am not a relative or employee or attorney or counsel of any of the parties or a relative or employee of such attorney or counsel or financially interested in the action. WITNESS my hand and seal this _____ day of _______________________, 2001. __________________________ LINDA R. BURT, C.S.R. Certified Shorthand Reporter State of Kansas 195