Thursday, February 21, 2008

TRANSCRIPT: Technical Briefing - Hallmark/Westland Meat Packing Company - (02/21/08)

Thursday, February 21, 2008 TRANSCRIPT: Technical Briefing - Hallmark/Westland Meat Packing Company - (02/21/08) Release No. 0054.08 Contact: Office of Communications (202)720-4623

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TRANSCRIPT: Technical Briefing - Hallmark/Westland Meat Packing Company - (02/21/08)

AUDIO: Technical Briefing

MODERATOR (Corry Schiermeyer): Hello, everyone. Thank you for joining us again. Today we will have, and I'll go through the list of names that we have here in the room that can answer some of your questions –

We're not going to start with any opening remarks or anything. I'll go through the list, and then we'll just go directly to questions.

So we have Dr. Scott Hurd, USDA deputy under secretary for Food Safety; Dr. Kenneth Petersen, assistant administrator, Office of Field Operations for USDA Food Safety and Inspection Service; Bruce Knight, USDA under secretary for Marketing and Regulatory Programs; Bill Sessions, associate deputy administrator for Livestock and Feed Programs, USDA Ag Marketing Service; Dr. John Clifford, USDA chief veterinarian officer; Eric Steiner, associate administrator for Special Nutrition Programs, USDA Food and Nutrition Service; and Ron Vogel, associate deputy administrator for Special Nutrition Programs, USDA Food and Nutrition Service.

And at this time, we will open up to questions from the media. Thank you.

OPERATOR: At this time if you would like to ask a question, please press *1. You will be announced prior to asking your question. To withdraw your question, *2. Our first question comes from Elizabeth Williamson, Wall Street Journal.

REPORTER: So if you could, I know you don't have any opening remarks, but what's the status of this recall, and what efforts are you pursuing to round up this 143 million pounds of meat?

DR. PETERSEN: Hi, this is Dr. Petersen. While we are initiating this recall, really consistent with how we would do other recalls, other than the size of it, but we have rather defined procedures. We have a recall direction board, where my folks follow certain prescribed procedures. That directive is available on our home page for those who want to get into any of the details of that. But basically the way it works is, the recalling firm, obviously in this case Hallmark, identifies their initial primary customers, who they sent products to. And that could be either other producing facilities—obviously in this case some of them were facilities that produced for the School Lunch Program. They could be facilities that produced for commercial markets or also in the School Lunch Program. And then those locations typically distribute further down the distribution chain.

And so we start out going to those locations, find out what they made and who else they distribute to. And as part of that initial notification that Hallmark would do, they would tell them, "Here's the products you receive," and tell them what they would do with it, which is in this case obviously control it, and then to destroy the product by either landfill, incineration or inedible rendering.

And we work our way down the distribution chain until we develop basically all points of distribution down to the point of purchase for consumption. And once we have that, then we go randomly to various locations. Again this is a Class II recall, so I would go to a certain prescribed number of locations—that's based again on my directive—and make sure that folks throughout the distribution chain were notified that they had the products, they knew what to do with it, and that they took the appropriate action. And if we get to a location where that didn't occur, then we will cite them for failing to follow the provisions of a recall.

So we've already begun that practice. We really began it over the weekend. I mean certainly on the commercial side the folks in Marketing Regulatory Programs, because of the School Lunch contracts and tracking, have a slightly different nuance on it. So we're starting to track it through the chain.

But sitting here today, I cannot tell you how many locations in aggregate the product has gone to. And obviously we'll go to them and gather the information and really proceed from there. So our focus is on identifying the locations, the locations we go to make sure the products are under control and that they have notified their further customers if any that they received product. And that's standard practice for any recall that we do.

MODERATOR: Before we go to more questions, I'm going to just have Eric Steiner from Food and Nutrition Service kind of update you on their side of things.

MR. ERIC STEINER: Hi, Elizabeth. This is Eric Steiner from the Food and Nutrition Service. Regarding the federal nutrition programs, we do have some updated numbers. I would caution to say that these numbers are still a little fluid, but this is the latest we have at this time.

Of the 143 million pounds involved with the recall, we have about 50.3 million pounds that went to federal nutrition programs. Of that 50.3 million pounds, we have 19.6 million pounds were consumed. We know that 15.2 million pounds are currently on hold. And we know that 15.5 million pounds are actively being traced. And these numbers will be updated as states are able to ascertain the location of the remainder of these products.

REPORTER: Thanks. Will these products be destroyed at all levels of the distribution chain?

DR. PETERSEN: Yes. Because of the nature of the regulatory violation, meaning that the products are unfit, there's no way to make them fit. And so the only option is terminal destruction.

REPORTER: So no matter where this appears, no matter how if it's mixed into I don't know a product or some prepared food or even if it's mixed with meat from other plants or other processors, if that Hallmark/Westland meat is present, that product must be destroyed?

DR. PETERSEN: Correct. I guess theoretically to get to some infinitesimal, immeasurable level even very small fractions – let's make a number up, a half of 1 percent – if a product had half of 1 percent of Hallmark, then that product will have to be removed from commerce and destroyed.


MODERATOR: Thanks, Elizabeth. Jon Rockoff Baltimore Sun.

REPORTER: Hi. Thanks for taking my call. I was wondering how many inspectors you have in the plants and whether you think that's enough.

DR. PETERSEN: Well, we cover about 6,200 plants in the federal system. About 5,300 or so of those are slaughter and processing type establishments, and the other 1,000 are types of warehouses and other distribution points. Covering all of those, my in-plant workforce is currently over 7,500 people. And the last year and a half or so we've been really rather aggressively hiring. In fact I probably have 200 more people on-board today than I did last year at this time. And that's more people than I've had on board since really any time since 2002 or so. That's despite the fact that the number of establishments has gone down a little bit due to some consolidation over time.

So we're always looking to hire. My current staffing level, my current vacancy rates are certainly something that we think is manageable. And we do our hiring in concert with our appropriation. In slaughter plant, I typically have a lower vacancy rate; that's because of the demands that's on the slaughter system. But even if I get an assignment that's vacant, I still cover that with relief people and through other mechanisms. So that's kind of the high level I think of where we are in the staffing.

REPORTER: How many vacancies do you have?

DR. PETERSEN: Overall vacancy rate is about 9 percent. It varies by location. For example, New York City would be a difficult place for me to continually find people and keep them. Other parts of the country are easier to find and keep people, but in aggregate 9 percent is about our current vacancy rate, balancing both slaughter and processing vacancies.

REPORTER: So what if there was no vacancy rate? What would your staffing level be?

DR. PETERSEN: If I had 100 percent full employment it would be certainly somewhere north of 8,000.


DR. PETERSEN: Right. Which is an employment level that we've never had.

REPORTER: One last thing. Do you think the way things are set up now that there's enough inspectors assigned to plants to keep track of all the different areas of the plants and make sure that while they are in the slaughter area something untoward isn't happening in the pens, that sort of thing?

DR. PETERSEN: Well, in the slaughter plant, which is obviously of recent interest, inside a slaughter plant whatever carcasses are going down the line we have 100 percent continuous presence. Somebody is in there every minute. Outside in the ante mortem pens, because dealing with live animals, we as folks have some sense of by now, we inspect them. The plant has to tell us, these are the animals we're going to slaughter; we go out and inspect them, and then at some random basis we go out and make sure that they are being handled humanely.

So in the ante mortem pen, I don't have somebody obviously standing next to every employee every minute of every time of the day of operation. So that's kind of the state of the art we are today. As far as coverage, of course the nature of the food production system today is quite a bit different than it was 100 years ago. And so we want to make sure we focused our inspection based on 21st century hazards and not necessarily based on how we did things 100 years ago.

MR. SCOTT HURD: Jon, this is Scott Hurd. Just to clarify, in the slaughter plant as Dr. Petersen was saying, when they turn on the switch there is no vacancy; it's fully staffed. Is that correct, Ken? Everybody is there on-line when a slaughter plant turns on running. So the vacancy rate that he's talking about is nationwide for all the workforce. But everybody's there, and everybody's ready to go when the plant starts operation, or it can't run.

MODERATOR: Thanks. If we can go on to the next person, please?

OPERATOR: Andrew Martin, New York Times.

REPORTER: I just had a quick question, and that is, do you plan to release the places where this meat went? And if not, why not?

DR. PETERSEN: Okay, it's Dr. Petersen. As some of the folks know, I think you've tracked some of the things we do in FSIS, beginning a couple years ago, it really started with a petition but also through some other external interests in initiated rulemaking to provide for that, meaning notification to the public of locations of distribution as we talked about the beginning, throughout the distribution chain. Store by store.

Currently, and that was really the basis for the rulemaking, that information was considered proprietary information. That is, the customers of the businesses was considered proprietary. That's the regulation that's on our books today.

And so we've done a proposed rule, we've gotten comments on the proposed rule, and we're ready to issue a final rule. I can't give you a date on that. It's intended to be sometime this year. Our intent is to final that rule. So it kind of depends on in this particular recall when that rule goes final. And that's not something I personally would have any influence over.

But technically today I would not post them. If the rule was issued next week, then theoretically we could post them. That's the rules we're living with today.

REPORTER: Thank you.

OPERATOR: Ben Goad, Press Enterprise.

REPORTER: Hi. Is there any plan to test the meat that's being recalled right now?

DR. PETERSEN: This is Dr. Petersen. No. Really as a matter of course no mater what recall I do, even if it's Class I recall for a real food safety hazard, once we initiate the recall we've really made our decision. And meaning that we at some level the product has to be either removed from product, removed from commerce which is the case here, or in say an e-coli situation you could potentially cook it to deliver the value.

So any additional testing isn't going to really tell me anything. In this particular case it's an unfit situation, meaning these animals didn't receive the follow-up ante mortem inspection after they had already been inspected that should have happened. So there's no way to test or correct that error, so given the remote risk, given that I've already made my decision to recall, and given that frankly there's no test that's going to tell me anything and even if there was it wouldn't change the actions we're taking—

If we're destroying all of these products, I don't need a test to inform me that I'm going to do anything different. So that's how we're going to proceed.

REPORTER: What about the people that have already consumed the meat?

DR. PETERSEN: Well, I'd have to, you know, maybe go back over the facts here. And the facts are, you know, we had some animals that were presented on ante mortem, they were found healthy. And on a rare occasion through our investigation we learned that an animal would occasionally go down and the plant was expected to notify us so that we could, my veterinarian could reexamine that animal. But that's all predicated on a whole, you know, broad strategy of both food safety controls but, more importantly in this case, BSE controls in the United States going back to surveillance that began in the 1990s, the FDA feed ban that began in '97, aggressive surveillance by the department that began in 2004 in which we did upwards of 800,000 tests of animals, cattle, focused those tests on high risk end of the spectrum. Only 2 of those roughly 800,000 animals were positive. Both of those were born before the feed ban.

Then we get to a slaughter plant. We have a downer ban, which the Harvard Risk Assessment tells us controls roughly 3 percent of the risk. And most importantly at the slaughter plant we have removal of specified risk material, which the Harvard Risk Assessment tells us is slanted toward mitigating upwards of 99 percent of any possible risk.

So given all of that, what we tell the public and what we have been saying is, this is a Class II recall. The reason we call it a very, very remote probability of any adverse illness is because of everything I just said.

REPORTER: Finally, we understand that there's folks from the USDA and the FDA out at the plant today. Do you know what's going on there, if that's the case?

DR. PETERSEN: Well, as we've been saying, I haven't been tracking the comings and goings of investigators. But the investigation still going on as folks have been tuning in obviously are well aware. So I wouldn't be surprised that we're doing additional investigation as we would with any investigation, not just in the government, any investigation by any law enforcement personnel. They get information, they circle back, they talk to other people, cross-check facts, so if they are there today or yesterday none of that would surprise me.

MODERATOR: Next question please.

OPERATOR: Dana Walker, ABC News.

REPORTER: Thank you. I'm wondering if anyone has gotten sick from the meat or if there's anymore concern or any further recalls.

DR. PETERSEN: This is Dr. Petersen. Actually there has been no reported illness, and this is certainly a recall that goes back two years. Given the nature of what I'd said in response to the previous reporter and the decisions we made on this particular recall, we really don't envision there to be any illnesses. But the facts are, there have not been any that have been reported.

REPORTER: So there won't be any further recalls?

DR. PETERSEN: Well, I hate to, I've learned I never say never. We took a rather aggressive approach with this recall based on the facts we learned in the investigation; 143 million pounds is aggressive. It goes back over two years. And so I think in the absence of some rather sweeping new facts, I don't see the need for any additional recall because we've recalled everything basically on the beef side of this produced over the last two years.

REPORTER: Thank you.

OPERATOR: Sally Schuff, Feedstuffs.

REPORTER: Hi. Thank you for taking my call. I'm sorry if I'm repeating something that was asked earlier. I came on the call a little bit late. I was wondering, how many cows or animals do you have evidence of that went into the plant without being properly reinspected when they went down? Dr. Raymond said on the last call that you had evidence of the practice going on for two years. Can you say how many cows it was?

DR. PETERSEN: I know the information but it's part of the investigation. I'm unable to share it with you. The way we've explained it, which is the best way we're able to explain it and preserve the investigation is, we know that it was a very rare occurrence. But obviously, given that we went back two years, we obviously have some reason to believe that it occurred at some frequency going back two years. So I'm going to have to leave it there on that particular question.

REPORTER: Okay. I have a follow-up on that. The question was asked on a call, not a USDA call but it was asked, what are the reimbursement issues on the USDA food programs? Was it 50 million pounds you said that went to USDA food programs? Who pays?

MR. BILL SESSIONS: This is Bill Sessions with the Agricultural Marketing Service. USDA will pursue every avenue available to us to reimburse the states for the cost of replacing the products that have to be destroyed as well as the transportation of the product to the disposal sites, disposal fees, and that sort of thing. So essentially, and we'll do that, the primary way will be through, we will take a warranty action against Westland to try to recover some of these costs. But essentially it's USDA's responsibility to pursue this through these actions to reimburse the states for these designated costs.

REPORTER: Thank you so much.

OPERATOR: Victoria Kim, Los Angeles Times.

REPORTER: Hi. I'm wondering if Hallmark/Westland has submitted a corrective action plan yet? And my understanding is that the initial suspension of inspection was because of mean handling practices. Are there going to be any additional measures now that you've determined that there were other failures at the plant?

DR. PETERSEN: This is Dr. Petersen. No, they've not submitted any corrective action. I think as we've indicated before, that's strictly up to them, the timing of it. My guess is they would want to tell me what they have done rather than what they intend to do. So that's just a guess. We did, you're correct, the initial suspension on I guess it was February 4 was targeted to regulatory violations associated with the humane handling situation. When we identified over the weekend that the regulatory violations were not giving us a chance to reexamine animals that had already been inspected, I did amend the suspension to put that additional concern in front of them. That's part of any normal due process. I put them on notice of what we're concerned about so that they can appropriately respond to it.

So we amended the suspension, but it's just another thing they would need to respond to in their response whenever they get around to it.

REPORTER: And once they submit that response and if that's approved by the USDA, are they allowed to open immediately? Is that how it works?

DR. PETERSEN: Yeah. I mean, a little term of art. I don't really approve them; I just need to be quite confident that what they're proposing identifies what happened, give some rationale for why they believe it happened, and then most importantly identify significant, and in this case multilayered, corrective actions that give us some level of confidence that it's not going to occur in the future. And then we verify their corrective actions over a multi-month period of time.

So that could, that turnaround could be, depends on the quality of what they submit. Just telling you how it usually works, it's rare I get a submittal and say thank you, it looks wonderful." There's always some back and forth, clarification or additional expectations by the agency. But the short answer is, consistent with due process if they give us a sufficient response we would allow them to operate. And then we've also made it clear I think in other calls, the administrative action on the suspension is totally separate from anything that the Office of Inspector General is doing on their investigation.

REPORTER: Can I just ask one follow-up? Can you describe the details of the warranty action against Westland?

MR. BILL SESSIONS: This is Bill Sessions with the Agricultural Marketing Service. Our contractual provisions are very specific, and states that if there is a food safety recall of any of the products that are provided by a contractor then the contractor is responsible for paying for all the costs associated with that recall and the destruction of the product. So we will be, in the days to come we've already notified Westland that we intend to initiate a warranty action. And we will be going through the legal process to do that over the coming days and months.

REPORTER: Thank you.

OPERATOR: Patrick Temple West, the Medill News Service.

REPORTER: Good afternoon. Is there anything more known about the inspector at the Westland plant or how these infractions slipped past?

DR. PETERSEN: Well, of course there is some more known, but that's still wrapped up in the middle of the investigation, and as we've suggested the investigation, as with any investigation, some back and forth. You go here, you go there, you get some information, and maybe go back and talk to people. So that's wrapped up still in I think a variety of interviews with a whole variety of parties. And so it's premature for me to reach any conclusion on where they are with that.

REPORTER: Okay, thank you.

OPERATOR: Stewart Doan, AgriPulse.

REPORTER: Yes. Thank you for taking my call. A question for Dr. Petersen. I need a clarification on a quote that was attributed to you earlier this week, USA Today that USDA said Monday it would step up oversight at 900 slaughter facilities, and you're quoted as saying, "The extra checks will give us a better handle on that." Did you make that statement, number one? Number two, can you clarify what you meant by "extra checks?" How much more oversight are you envisioning here?

DR. PETERSEN: Well, what we discussed in that particular interview was related to the ante mortem inspection and obviously humane handling. We've had some past practices, we have a lot of data that shows that I believe the activities that we're doing have been sufficient, and we know that we have suspended plants in the last year or so for egregious inhumane handling errors. So my inspectors are identifying egregious errors. We know that we identify what we call "nonegregious humane handling violations," such as not having water in the pens and that kind of thing. We have cited the plants upwards of 600 or 700 times last year for those kind of less-egregious violations, which is a relatively small number given the scope of everything we looked at.

But all that aside, and just given everything we know with this particular situation, given some of the facts we're finding in the investigation, considering options on how I want to perhaps reaffirm what our data is already telling us, and we're pulling together some options on that. It's still something we're considering, and that was the nature of the conversation. And I think in the coming days we'll be most likely giving you all some clarity on how we might proceed with that.

REPORTER: So this was not a, it's not being implemented yet, and second part of that question: How did you come up with 900?

DR. PETERSEN: Oh, I'm sorry. Okay. Yeah, it hasn't been implemented yet with any national strategy. I want to make sure we've looked at all the options and then selected the right strategy before we ask folks to go about and do the work.

Nine hundred is, in the federal system, the universe of livestock slaughter plants, all livestock, and roughly 600 of those plus or minus would be plants that slaughter cattle. And so 900 is all livestock, meaning plants that are subjected to the Humane Methods of Slaughter Act.

REPORTER: Thank you.

OPERATOR: Gillian Flaccus, Associated Press.

REPORTER: Can you hear me?


REPORTER: Hello: Can you hear me?

REPORTER: Okay. Sorry. My question is, first of all, what percentage, do you know what percentage of school meat was provided by the Hallmark plant in the overall program?

MR. BILL SESSIONS: This is Bill Sessions with Agricultural Marketing Service. Over the past few years you could say that roughly 20 percent of the ground beef that was purchased by AMS and it was provided to federal food and nutrition programs was provided by Westland Meat Company.

REPORTER: Okay. Thank you. And a follow-up question, can you just describe quickly how plants are selected for the school meat program, how that process works, and how many of them there are that provide meat to the School Meat Program nationwide?

MR. BILL SESSIONS: Sure. We have an eligibility process for suppliers that they must go through to be eligible to supply. And this is in course with the federal acquisition regulations. First they have to demonstrate financial solvency and their ability to be financially independent. They have to have the technology and the means as far as the equipment and the personnel to perform the task. They then have to submit what we call a technical proposal, and that outlines all of how they, all the specific processes they will go through to meet the requirements that are contained in our specification and contracts. And then once they submit that technical proposal, it is subject to a desk audit by our scientific staff back here in Washington. Then if it passes that, then they are subjected to an in-plant audit, and that means that they have to be doing what they say they're doing and what they are doing meets the requirements contained in our specification and contractual requirements.

After that, they then become what was known as an "eligible supplier," and they then have to compete on a low-bid basis for the right to supply product. Once they are awarded a contract, we have an in-plant grader that is there monitoring the actual preparation and grinding process, and they oversee all aspects of that. In addition to that, we have monthly audits that they come in and look at all aspects of what was going on there. And additionally – I should say the plant would be operating under a federal grant of inspection; that's the foundation that we build on. We are really no different than any other large commercial purchaser of ground beef items. We rely on our colleagues at FSIS to provide that foundation of safety; then we build on that with other specific requirements that meet the end needs of our users.

REPORTER: Thank you. And the second part; of that question was, do you know how many plants there are that do provide meat that have gone through all those steps and currently provide meat for the federal school lunches?

MR. BILL SESSIONS: Currently we have 10 suppliers that are eligible. These are grinders that actually produce, manufacture the end items that we purchase. And those 10 grinders are supplied by 23 approved su8ppliers of boneless beef. These are the harvest facilities that actually slaughter the cattle and prepare the boneless beef and then provide those to our 10 eligible grinders.

REPORTER: Well, Hallmark would have been one of the 23 suppliers, not one of the grinders, right?

MR. SESSIONS: Hallmark and Westland was – they are two operations side by side, and Hallmark was the slaughter operation; Westland was the grinding operation. And we, for our purposes of contracts we considered those one operation.

REPORTER: And you said over the past few years about roughly 20 percent of the ground beef in the School Lunch Program had come from Hallmark Westland?

MR. SESSIONS: That's on average. I can, you know if you need specifics we have all that out there on our website. But roughly a good rule of thumb is about 20 percent.

REPORTER: Thank you.

OPERATOR: Sara Rosenfeld, NBC News.

REPORTER: Hi. Thank you for taking my question. I was wondering if you could go into the inspection process in general a little more in depth. And since the Humane Society had gotten this video under cover, what other means do you have besides direct surveillance to ensure the integrity of the process?

DR. PETERSEN: Okay, this is Dr. Petersen. The inspection process at ante mortem is, you know, animals arrive on trucks, and then they're unloaded. They can be unloaded any time of day or night. And they are held in pens, and then when the plant is ready to have them slaughtered, they notify FSIS that we have animals, you know, to be inspected. And depending on the facility that can be from a few to just hundreds and hundreds, if not thousands. And we go out and look at those animals, talking about livestock now, at rest and in motion.

And then any animals that say are in this case nonambulatory we would condemn them. And no matter what the – well, that's what we would do certainly for cattle.

Then other animals can have other, you know, maladies, various infections, eye infections, mastitis, that kind of thing. Some of those animals may be eligible for slaughter but we want to track them more closely, so we separate them and designate them what we call a "U.S. Suspect." Those are basically animals that have some kind of disease malady but the veterinarian doesn't think it's sufficient to condemn them on ante mortem.

The bulk of the population, normal animals once we pass ante mortem inspection, then they go to slaughter, and then they are humanely stunned when they enter the facility.

The U.S. Suspects as I said are slaughtered separately, and the veterinarian examines them separately. And then the veterinarian correlates their ante mortem findings with any findings they have on that specific animal on post mortem, and then make the decision on whether that animal can proceed to slaughter.

So that's it, at least on the ante mortem side.

Now post mortem, livestock going to the plant, they're humanely stunned, rendered insensible. And then they're shackled and raised and they are exanguinated, bled out, and then we begin the dressing process which depending on the species you know say in cattle involves sanitary removal of the hide. Many facilities have a variety of interventions to minimize (unclear) from microbial contamination such as things such as applying steam at various points or some acid rinses to reduce bacteria. And then somewhere in the slaughter process they present the animal for post mortem inspection by federal inspectors. And federal inspectors look at each carcass and each part, and then they make a decision on whether the part, for example the liver, is acceptable for food. And if not, they condemn it.

Then they inspect obviously the balance of the carcass to make sure it's fit for food. And then we apply the market inspection if they are acceptable, the plant then typically at the end of a cattle slaughter line will apply a terminal intervention such as hot water or steam to reduce any chance of pathogen contamination. Many of these plants do extensive microbial testing. Certainly FSIS does a variety of microbial testing. So that may be a little more than you want, but that's kind of how we do it.

And then I think you had another question in there that I may not have gotten to?

REPORTER: Yes. Beyond inspectors actually inspecting the meat or surveilling the process, do you have other means of knowing?

DR. PETERSEN: There has been of course there's been some recent discussion on it also but over the last few years there's certainly been this discussion of this, say, shall we have video surveillance in livestock pens? That came up initially a couple years ago, and what the agency did at the time was we wanted to initiate some routine surveillance. And the routine surveillance we were doing was this humane handling random checks that we've been talking about in the last few calls.

And so that's what we put in place then. And so obviously it's part of this investigation. We're going to take a closer look at are we getting everything out of that that we envisioned?

And if not, are there different techniques we should be doing for that kind of random audits? For example, coming into pens at different areas am I doing that? Am I truly doing it randomly throughout the day?

So we've been doing that. We're going to assess it. And then there are certainly some of these old ideas will invariably come back up such as: should I have video cameras, should I maintain video tapes, and is that something the government should set up and fund? Is that something that we should require industry to set up and manage? Those are all open questions.

And I think we'd get a little farther into the investigation when we get closer to the conclusion point before we'd make a recommendation on whether that's something that we think is appropriate.

And then you'd obviously look at the type of facility. Should you do the same thing in all facilities? Do they have the same risks in a plant that slaughters young animals such as market house? Or do I focus that kind of activity of plants that slaughter cull animals such as diary cattle? So there's a lot of different ways to think about it.

But at the end of all this, or even in the middle of all this, we want to assess what we've been doing throughout the board. We want to assess what industry is doing, and then we want to learn anything that needs to be learned from the investigation, obviously get new ideas from the general public and put the best program in place.

REPORTER: Thank you.

OPERATOR: Miriam Falco, CNN Medical News.

REPORTER: Hi. Thanks for taking the questions. I've got a couple questions. First of all, Mr. Steiner, could you go over those numbers again for the 50.3 million pounds that went into the federal nutrition program?

MR. ERIC STEINER: Yes. This is Eric Steiner with the Food and Nutrition Service. Of the 143 million pounds involved with this recall, 50.3 million pounds were distributed through the federal nutrition programs. Of that 50.3, 19.6 million pounds have been consumed, 15.2 million pounds are on hold, and 15.5 million pounds are being actively traced. And again, these numbers are still a bit fluid, and we'll update the numbers as states are able to ascertain the location of the remainder of these products.

REPORTER: Thank you. And for Dr. Petersen, you say you consider these rare occurrences at this particular plant, but if you look at the video tape there are at least three or four or more different cows. So what do you consider rare occurrences at this particular plant? And then you also answered earlier that there was no indication of illness. I'm not sure how you're answering that question. Are you talking about e-coli or salmonella, because obviously if there were any chance that any of these cows might have had BSE, we wouldn't know if anyone got sick for 10 or 15 years. Correct?

DR. PETERSEN: Okay. A couple questions in there. The rare situation refers to the fact that we inspected them first and then between inspection and where they enter the actual slaughter facility they went down. So there were, can't further clarify this today, but as a result of the investigation we know there were rare situations where animals we first inspected when down. So that's the rare piece.

And we say they are healthy because we looked at them first on ante mortem. And so for animals to appear healthy, obviously these are mature animals, and we looked at them at rest and in motion. It would be rather inconsistent with a lot of disease conditions for them to go down, you know, right off the bat.

Then the key – I mean there are several keys. But even on the rare ones that went down, we mentioned earlier about removal of specified risk materials inside the facility. That is the single key mitigation strategy. And we know from our inspection records and from plant records that that was being effectively implemented every single day.

And that's removal of things like the brain and spinal cord and that kind of thing.

The animals you saw in the video are not animals that would have passed ante mortem inspection. Those animals are down. And some of the animals that you saw down were so severely distressed that they're just not going to get up. And so we've got to be careful you know what facts we're kind of looking at.

Yes, there was egregious, completely unacceptable movement of those animals. But animals in that condition, you know based on a lot of experience here, don't just kind of get up and start moving around. And if they do, they are certainly not going to be the kind of animal that's going to be readily passed by inspection personnel.

REPORTER: But then how did your inspectors – if I understand it properly, you're saying once they got into the facility where your people are 100 percent of the time while slaughter is going on, even if they're not outside where they're being pushed into this facility, it would have come up? What I don't understand is, how you're parsing this out. You're saying that those never would have passed inspection anyway. But we see video of them going into the facility. So at what point does your inspection pick up on this?

DR. PETERSEN: Well, I guess I would, I'd have to maybe have a disagreement here. I don't see evidence of those animals going into the facility. I see evidence of certainly inhumane handling. But those animals I don't see being forcibly forklifted up into the establishment, much less killed and brought into the establishment. So that's video. So I just don't see that.

We do have evidence obviously that some apparently healthy animals then went down, but apparently healthy animals are not what you observed in the video, and those animals are not the kind of thing that would have again passed ante mortem inspection.

REPORTER: What about your comments about, Nobody got sick?

DR. PETERSEN: Well, we go back to the rather I think exhaustive discourse we had earlier on, you've got to look at the facts of BSE in this country, and the facts here are wildly different than they were certainly in the European Union. And the facts on surveillance activity that we found, the extremely low prevalence in the U.S., it's not zero but it is extremely low, mitigations that were put in place over a decade ago for feed ban to mitigate exposure, and then activities at the slaughter plants, downer plant, banning, and the key is the SRM removal.

Then certainly any stressed animal can exhibit – shed pathogens at a more readily rate. But the plant processes as we mentioned earlier are designed to address logarithmic reductions in pathogens. And in this facility we did extensive testing, we the Department, and much of that testing was done by Agriculture Marketing Service, and we know in the last year upwards of 500 samples of finished product was collected, and they were all negative for e-coli 0157H7.

So you know, I don't want to suggest that any of this is okay, certainly not the handling and letting animals go into the plant without calling us back out to inspection. But there are other multi-hurdle strategies in place, and the reason that it's important to have a multi-hurdle strategy is so that you don't hang your hat on any single control point.

MODERATOR: Thank you. Next question.

OPERATOR: Janet Wilson, LA Times.

REPORTER: Hi. Kind of going way back to near the beginning, I'm trying to understand fully the production and distribution chain. How many sources, facilities or cows or whatever can a single lot of ground beef come from? I mean was the processing side of this business just getting meat from the slaughtering side, or is it coming from all different kinds of places? And is there adequate trace-back? I mean, you were talking about how you can have even an infinitesimal amount or half a percent. I mean how is it possible to adequately trace back where all of the meat came from?

And kind of a related last question, I don't believe you guys currently have mandatory animal ID, and I'm wondering why that is.

DR. PETERSEN: Okay. This is Dr. Petersen will start. In this particular facility the vast preponderance and to my information it's well over 98 percent of the products they distribute were slaughtered at that facility. They didn't happen to bring in other products from other facilities. But federal establishments are required by law, Federal Meat Inspection Act but also by regulation, to maintain certain records. And so this plant would have records of everybody they distributed to going back the last year or two.

So I know right off the bat who those folks are.

Then I go to, say, Plant B, and they are required to keep records, both of receipt of product and then if they mix this product with product from another facility their production records need to show me that. And we've done enough recalls – the record, the tracing forward of products because of the required recordkeeping has never been an issue for us. Establishments know, and it's really required business practices, that these are the records you have to keep. And it's customer records and that kind of thing.

So we know who they are, so we have to go location by location to find out: what did you receive, when did you receive it? Did you make it into one product or 10 products? And we would still know that information and we'd track it down the chain to find their further customers.

And then I think we have Dr. Clifford with us who can touch on the animal ID piece.

DR. CLIFFORD: Hi. This is Dr. Clifford with APHIS Veterinary Services. Let me just mention animal ID. First and foremost, animal ID within APHIS Veterinary Service is for animal health purposes. Having said that, a lot of people do not recognize the fact that there's multiple ID systems out there. In fact a lot of our disease eradication and control programs have mandatory ID requirements for those specific programs.

Now with regards to the National Animal Identification System, that's a system that's been in cooperation with the industry and the states that we've been developing and implementing. It is a voluntary program with regards to producer participation. We felt it was better to address this program from a voluntary nature in getting the cooperation of the industry sector within that.

Also though as that program has been developed and implemented, we've been incorporating those standards into a single system over time. And that's not a short term. So that as we move toward one system we will eventually go away from other ID systems that were specific to a disease in a specific species program.

So that's our goal.

REPORTER: That's helpful. I'm a little bit confused just in terms of then for this particular type of product, ground beef and for the School Lunch Program let's say, is it possible to trace back to which farms and which cows it would have come from at this point through those specific programs that has a whole myriad regulation?

MR. BILL SESSIONS: This is Bill Sessions with the Ag Marketing Service. We do have in addition to the trace-back and trace-forward requirements of Food Safety Inspection Service we have even more stringent requirements relative to trace-back and trace-forward right down to the chub of meat. If it goes forward into commerce, we can pick up any of our food nutrition programs we can pick up a chub of the meat and be able to almost instantaneously know what plant it came from, on what day it was produced, what hour, and so forth. And then within that we can tie it back to a number of carcasses. But we cannot trace it back to the farm.

REPORTER: Do you think you should be able to? Would that be an additional safeguard you'd recommend for instance for a school lunch program that uses a lot of ground beef as I understand it?

MR. BILL SESSIONS: Well, our specification and contractual requirements are continuously under review and we look at the best science and best industry practices, and again if that's something that we need to do as an agency we will certainly consider that.

REPORTER: Okay. But do you think you need to do it as an agency is my question.

MR. BILL SESSIONS: At this point we don't think that necessarily needs to be done. We have a lot of requirements in place such as all of our beef is of domestic origin. That means they have to come from cattle that are originate that are U.S. produced. We pull all the, we make sure that the spinal cords and other excluded materials are removed. We require that the vendor have pathogen intervention steps in their slaughter process such as steam pasteurization. We require the routine testing of carcasses for e-coli 0157H7 to verify that the interventions that the harvest facility are using are effective. We require that the quality control cram be documented with a technical proposal and that this is constantly reviewed. We again, the boneless beef is traceable to a number of carcasses there back to the source, to the harvest facility.

REPORTER: When you say a number of carcasses, how many could it be from?

MODERATOR: Janet, we're going to need to move on. I'm so sorry, but we have a few more that we need to get to, and we're running out of time. But if you want to just follow up with us, feel free to give us a call.

REPORTER: Okay. Thank you very much.

MODERATOR: All right. Thanks.

OPERATOR: Eric Weiner, TBS.

REPORTER: Yeah. Thanks for taking my call. I wanted to know how this recall, how you think it's going to affect trading partners such as Japan. I know you seem to be sticking that the recall is going to fix the problem, but things like this I know from past experiences at least, that really makes trading partners nervous. Do you expect any negative backlash from this? Thanks.

DR. PETERSEN: Okay, it's Dr. Petersen. Actually this particular firm was not, as I understand it, a big exporter. So we engage with our trading partners obviously in an ongoing basis. It's bilateral, multilevel activities. They depend on the execution of our system. I don't think we're suggesting that this recall kind of takes care of everything, just we think a recall is obviously a failure. There is a problem. But it's really in the food safety arena it's all about ongoing effectiveness of processes. That's what we demonstrate through our laboratory sampling. It's certainly OIE related activities. And understandably our trading partners are quite interested in what's going on. But they also recognize kind of what's happening in the broader arena of food safety in the U.S. and the fact that we have generally effective constructive trade with them I think indicates that they think we have a reliable system.

UND. SEC. BRUCE KNIGHT: This is Under Secretary Knight. If I could supplement what Ken had stated, this particular plant was not in the export market. As we look back over the last two years there were only two countries to which it had sent any export products. One was the Ivory Coast and the other one was another African nation. The kinds of products that go to the major markets like that you're talking about in Japan are traditionally coming from young, fat animals from which you derive steaks, roasts, premium cuts such as what we send to Japan. And this was one, this plant was dedicated primarily towards lean animals that would be just primarily for hamburger use.

DR. PETERSEN: So in this recall again, kind of underpinning all of this, is that it is really not a health-related issue, it is a Class II recall, a very, very remote probability. That's quite different than I think other things that our trading partners would be more concerned with. So we're not even on that same level with this recall.

OPERATOR: Clarissa Kell-Holland, Land Line Magazine.

REPORTER: Hello. Does USDA have a plan in place right now to pick up the product that is currently on hold in the school cafeterias around the country? And has any of the recalled product been destroyed yet?

RON VOGEL: This is Ron Vogel from Food Nutrition Service. The answer to that is yes, we do have a plan to recover and destroy this product in accordance with FSIS requirements. None of that product has been destroyed yet, but we will require documentation from state agencies and schools that the product has been in fact destroyed in accordance with FSIS requirements.

REPORTER: Have any disposal sites been set up yet for the recalled meat?

RON VOGEL: Those sites will be determined in conjunction with state and local health officials. That's a process that will be handled –

REPORTER: Okay, thanks.

MODERATOR: We have time for one more question. Thank you.

OPERATOR: Bob Crower (sp), Capital Press.

REPORTER: Yes, thank you. I'm just wondering if you had any – it's kind of a two-part question – whether you've had any discussions with the Humane Society about their investigation and anything that they found either on this video or any other things that they might have that might help you in your investigation.

And then secondly, maybe what your message might be to groups like that to come forward more expeditiously with their allegations?

DR. PETERSEN: This is Dr. Petersen. As far as discussions we have or haven't had with any parties, that would be part of the investigation. I wouldn't be able to comment on that. I think our view on how this information came to light was certainly initially put forward by Agriculture Secretary Ed Schafer in his initial release that we were rather disappointed that apparently this information was known at least to them for some period of months, upwards of three to four months. And the agency was provided this information really concurrent with when everybody else was provided this information.

For me, that, it's up to them to of course decide how they want to proceed with their investigations. But for me, that's quite different than information, sharing I get from other related groups. One in particular does a lot of undercover kind of work, typically they will share that information with me or other agency in advance. We don't have the slightest qualms with anybody going public with anything. But sometimes if some of this information is shared at least somewhat in advance the agency initiates its investigation at a time when nobody really knows what it is we're investigating. And sometimes that can give you a little different quality of investigation than it does when everybody else has the information.

So but that's how it rolled out, and once we had the information as the Secretary charged us we aggressively began doing the investigation. And so we're going to move forward now that we have the information.

MODERATOR: Thank you. And thank you everyone that joined us today. If we did not get to your questions or if you have follow-up questions, please let us know here at USDA Communications. Our number is 202-720-4623. And also please continue to look at our website, WWW.USDA.GOV/ACTIONS is where we continue to update.

But again, if you have any questions, please let us know. Thank you.

usda spin machine, in high spin cycle;

Release No. 0048.08 Contact: Office of Communications (202)720-4623

Printable version Email this page


February 17, 2008

USDA Actions

Sunday, February 17, 2008

Release No. 0046.08 Statement by Secretary of Agriculture Ed Schafer Regarding Hallmark/Westland Meat Packing Company Two Year Product Recall

Release No. 0046.08


USDA Press Office (202) 720-4623

Concerning this beef recall and any potential link to Transmissible Spongiform Encephalopathy i.e. BSE and or h-BASE. the last two cases of mad cow disease in the USA i.e. Texas and Alabama were NOT of the UK BSE strain, but a new strain that is much more virulent to humans than the UK BSE.

due to the incubation period of TSE, these kids and their parents will not know for years, or decades IF they have been exposed and go clinical and die. TSE are 100% fatal, once clinical.

prion disease seem to vary among people depending on the prion gene variant they have, and incubation period could be one aspect in which the variants differ. as with route and source of agent, and titre of infectivity i.e. DOSE. Experts have said CJD is known to have a long incubation period, perhaps as long as 50 years.

the fda feed ban (the OTHER safe guard), was and is nothing but ink on paper.

Statement by Secretary of Agriculture Ed Schafer Regarding Hallmark/Westland Meat Packing Company Two Year Product Recall

February 17, 2008

"Today, USDA is announcing additional actions as a result of the ongoing investigation at Hallmark/Westland Meat Packing Company. USDA's Food Safety and Inspection Service (FSIS) has evidence that Hallmark/Westland did not consistently contact the FSIS public health veterinarian in situations in which cattle became non-ambulatory after passing ante-mortem inspection, which is not compliant with FSIS regulations. ...

>>>It also includes the removal of specified risk materials-those tissues demonstrated to contain the bovine spongiform encephalopathy agent in infected cattle-from the human food chain, along with the U.S. Food and Drug Administration's 1997 ruminant to ruminant feed ban. The prohibition of non-ambulatory cattle from the food supply is an additional safeguard against bovine spongiform encephalopathy. <<<


Date: March 21, 2007 at 2:27 pm PST




Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried, Recall # V-024-2007


Cattle feed delivered between 01/12/2007 and 01/26/2007


Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.

Firm initiated recall is ongoing.


Blood meal used to make cattle feed was recalled because it was cross- contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.


42,090 lbs.







The firm does not utilize a code - only shipping documentation with commodity and weights identified.


Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.


Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.


9,997,976 lbs.


ID and NV




and that is but one of many since the infamous 8/4/97 partial and voluntary mad cow feed ban. 2006 was a banner year for MAD COW PROTEIN IN COMMERCE ; PLEASE SEE LAUNDRY LIST OF MAD COW PROTEIN IN COMMERCE HERE ; SRM SPECIFIED RISK MATERIALS RUMINANT TO RUMINANT ANIMAL PROTEIN IN COMMERCE 2006-2007

Geographical BSE Risk (GBR) assessments covering 2000-2006 Date : 01.08.2006


[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk Materials for Human Food and Requirement for the Disposition of Non-Ambulatory Disabled Cattle 03-025IFA 03-025IFA-2 Terry S. Singeltary Page 1 of 17 9/13/2005

Sunday, February 17, 2008 Release No. 0046.08 Statement by Secretary of Agriculture Ed Schafer Regarding Hallmark/Westland Meat Packing Company Two Year Product Recall Release No. 0046.08 Contact: USDA Press Office (202) 720-4623

Subject: USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half (bogus BSE sampling FROM HEALTHY USDA CATTLE) Date: June 21, 2007 at 2:49 pm PST Owner and Corporation Plead Guilty to Defrauding Bovine Spongiform Encephalopathy (BSE) Surveillance Program An Arizona meat processing company and its owner pled guilty in February 2007 to charges of theft of Government funds, mail fraud, and wire fraud. The owner and his company defrauded the BSE Surveillance Program when they falsified BSE Surveillance Data Collection Forms and then submitted payment requests to USDA for the services. In addition to the targeted sample population (those cattle that were more than 30 months old or had other risk factors for BSE), the owner submitted to USDA, or caused to be submitted, BSE obex (brain stem) samples from healthy USDA-inspected cattle. As a result, the owner fraudulently received approximately $390,000. Sentencing is scheduled for May 2007. snip... Topics that will be covered in ongoing or planned reviews under Goal 1 include: soundness of BSE maintenance sampling (APHIS), implementation of Performance-Based Inspection System enhancements for specified risk material (SRM) violations and improved inspection controls over SRMs (FSIS and APHIS), snip... The findings and recommendations from these efforts will be covered in future semiannual reports as the relevant audits and investigations are completed. 4 USDA OIG SEMIANNUAL REPORT TO CONGRESS FY 2007 1st Half

FSIS STATES ; Bovine Spongiform Encephalopathy - "Mad Cow Disease" In addition, on December 30, 2003, Agriculture Secretary Ann Veneman announced new policies that would further strengthen an existing solid food safety system against BSE. On that date, an immediate ban was enacted to prevent all non-ambulatory disabled cattle from being used in the human food supply. This group contains the HIGHEST risk population of cattle that could possibly have BSE. However, even before this ban, FSIS inspectors at slaughterhouses were condemning all cattle they suspected of showing central nervous system disorders. snip... Are meats used in the National School Lunch Program safe? Yes. USDA's Agricultural Marketing Service (AMS), by specification, does not allow beef that is mechanically separated from bone with automatic deboning systems, advanced lean (meat) recovery (AMR) systems, or powered knives for any commodity programs. USDA procurement specifications for beef specifically prohibit the use of meat from downer animals - animals too sick or injured to walk.

In December 2003, USDA announced the first confirmed case in the United States of bovine spongiform encephalopathy (BSE). On January 12, 2004, FSIS published interim rules, effective immediately, banning HIGH BSE-risk, non-ambulatory (“downer”) cattle from slaughtering facilities; imposing new disposal requirements for certain potentially hazardous animal parts and organs; prohibiting the labeling as “meat” of mechanically removed muscle tissue; and banning a form of pre-slaughter stunning that can potentially spread infective brain and nervous system tissue into the meat.

Emergency Management and Information NetworkPennsylvania Department of Agriculture Bureau of Animal Health and Diagnostic Services John I. Enck, Jr., V.M.D., Director Telephone No: 717-783-6677 Fax No: 717-787-1868 BSE Talking Points January 2, 2004 United States for signs of central nervous system impairment. All animals exhibiting neurological signs during this inspection are condemned, and the meat is not permitted for use as human food. The brains from these animals are submitted to USDA's National Veterinary Services Laboratories for analysis. (The cow implicated in the recent case was not considered to be showing signs consistent with neurological disease, but was originally diagnosed with a traumatic injury as a result of a difficult calving). • In fiscal year 2002, USDA tested 19,990 cattle for BSE using a targeted surveillance approach designed to test the highest risk animals, including downer animals (animals that are non-ambulatory at slaughter), animals that die on the farm, older animals and animals exhibiting signs of neurological distress.


Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).

Audit Report Animal and Plant Health Inspection Service Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II and Food Safety and Inspection Service Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III Report No. 50601-10-KC January 2006

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain Our prior report identified a number of inherent problems in identifying and testing high-risk cattle. We reported that the challenges in identifying the universe of high-risk cattle, as well as the need to design procedures to obtain an appropriate representation of samples, was critical to the success of the BSE surveillance program. The surveillance program was designed to target nonambulatory cattle, cattle showing signs of CNS disease (including cattle testing negative for rabies), cattle showing signs not inconsistent with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS condemned cattle were sampled and made a concerted effort for outreach to obtain targeted samples, industry practices not considered in the design of the surveillance program reduced assurance that targeted animals were tested for BSE. USDA/OIG-A/50601-10-KC Page 27 observe these animals ante mortem when possible to assure the animals from the target population are ultimately sampled and the clinical signs evaluated. snip...

Bovine Spongiform Encephalopathy in a Dairy Cow—Washington State, 2003 JAMA. 2004;291:553-555. On December 30, USDA announced additional safeguards to further minimize the risk for human exposure to BSE in the United States (see box). Beginning immediately, FSIS has prohibited the use of downer cattle for food for human consumption. Through its emergency rule-making powers, FSIS will take additional actions that will become effective on their publication. Planned actions include the required removal of "specified risk materials" (i.e., high-risk materials) from animals aged >30 months at the time of slaughter and withholding the USDA "inspected and passed" mark until negative BSE test results are received for any animal tested. To enhance the speed and accuracy of the response to animal health threats such as BSE, APHIS is working to implement a national identification system to track animals of various species through the livestock marketing chain. USDA also will appoint an international panel of scientists with BSE expertise to provide an objective review of the response to the identification of the BSE-positive cow described in this report and to identify areas for potential improvement of current BSE safeguards. .......

see full text ;


kinda reminds you of these mad cows ;


Prepared by National Center for Animal Health Programs Ruminant Health Programs Team November 15, 2007


Infected and Source Flocks

During FY 2007, there were a total of 76 new infected or source flocks identified. Of those new flocks identified, 30 were infected flocks and 46 were source flocks (Figure 2). As of September 30, 2007, there were 38 scrapie infected and source flocks with open statuses (Figure 3). ...


In FY 2007, 331 scrapie cases have been confirmed and reported by the National Veterinary Services Laboratories (NVSL), including 59* Regulatory Scrapie Slaughter Surveillance (RSSS) cases (Figure 5 and Slide 16). In FY 2007, two field cases, one validation case, and two RSSS cases were consistent with Nor-98 scrapie. The Nor98-like cases originated from flocks in California, Minnesota, Colorado, Wyoming and Indiana respectively. Nineteen cases of scrapie in goats have been reported since 1990 (Figure 6). The last goat case was reported in September 2007.


see full report here ;

Like lambs to the slaughter

31 March 2001 Debora MacKenzie Magazine issue 2284

FOUR years ago, Terry Singeltary watched his mother die horribly from a degenerative brain disease. Doctors told him it was Alzheimer's, but Singeltary was suspicious. The diagnosis didn't fit her violent symptoms, and he demanded an autopsy. It showed she had died of sporadic Creutzfeldt-Jakob disease.

Most doctors believe that sCJD is caused by a prion protein deforming by chance into a killer. But Singeltary thinks otherwise. He is one of a number of campaigners who say that some sCJD, like the variant CJD related to BSE, is caused by eating meat from infected animals. Their suspicions have focused on sheep carrying scrapie, a BSE-like disease that is widespread in flocks across Europe and North America.

Now scientists in France have stumbled across new evidence that adds weight to the campaigners' fears. To their complete surprise, the researchers found that one strain of scrapie causes the same brain damage in mice as sCJD.

"This means we cannot rule out that at least some sCJD may be caused by some strains of scrapie," says team member Jean-Philippe Deslys of the French Atomic Energy Commission's medical research laboratory in Fontenay-aux-Roses, south-west of Paris.

Hans Kretschmar of the University of Göttingen, who coordinates CJD surveillance in Germany, is so concerned by the findings that he now wants to trawl back through past sCJD cases to see if any might have been caused by eating infected mutton or lamb. ...

Tissue distribution. For atypical scrapie, what is PrPres and infectivity distribution within sheep of different genotypes, particularly with respect to SRM removal? For classical scrapie and experimental BSE in sheep, tissue distribution of infectivity is widespread. Thus, even with SRM controls in place, an infected sheep poses around 1000 times the risk to human health than does an infected cow22. Does the distribution depend on whether infection is by the oral or 21 Gubbins S. Prevalence of BSE in sheep: interpreting the results of retrospective and prospective testing of sheep TSE cases. SEAC 84 open meeting 22 paper presented to Food Standards Agency board on 9 December 2004.

Also see paper SEAC/84/2 Annex 2: McLean, A. Page 13 © SEAC 27 February 2006

intracerebral route? Are some VRQ sheep carriers with no neurological symptoms?




Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Singeltary, Sr et al. JAMA.2001; 285: 733-734.

Diagnosis and Reporting of Creutzfeldt-Jakob Disease

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

To the Editor: In their Research Letter, Dr Gibbons and colleagues1 reported that the annual US death rate due to Creutzfeldt-Jakob disease (CJD) has been stable since 1985. These estimates, however, are based only on reported cases, and do not include misdiagnosed or preclinical cases. It seems to me that misdiagnosis alone would drastically change these figures. An unknown number of persons with a diagnosis of Alzheimer disease in fact may have CJD, although only a small number of these patients receive the postmortem examination necessary to make this diagnosis. Furthermore, only a few states have made CJD reportable. Human and animal transmissible spongiform encephalopathies should be reportable nationwide and internationally.

Terry S. Singeltary, Sr Bacliff, Tex

1. Gibbons RV, Holman RC, Belay ED, Schonberger LB. Creutzfeldt-Jakob disease in the United States: 1979-1998. JAMA. 2000;284:2322-2323. FREE FULL TEXT

APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006

[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

PRION DISEASE UPDATE 2008 (03) ****************************** A ProMED-mail post

ProMED-mail is a program of the International Society for Infectious Diseases

[With the continuing decline of the number of cases of variant Creutzfeldt-Jacob disease (abbreviated previously as vCJD or CJD (new var.) in ProMED-mail) in the human population, it has been decided to broaden the scope of the occasional ProMED mail reports to include other prion-related diseases. Data on vCJD cases from any part of the world are now included in these updates where appropriate, and other forms of CJD (sporadic, iatrogenic, familial, and GSS (Gerstmann-Straussler-Scheinker disease) are included also when they have some relevance to the incidence and etiology of vCJD. - Mod.CP]

In this update: [1] UK: National CJD Surveillance Unit -- monthly statistics [2] UK: SEAC 99th meeting report [3] BASE transmission risk

****** [1] UK: National CJD Surveillance Unit -- monthly statistics Date: Fri 1 Feb 2008 Source: UK National CJD Surveillance Unit, monthly statistics [edited]

Monthly Creutzfeldt-Jakob disease statistics -- as of 1 Feb 2008 ---------------------------------------------------------------- These following figures show the number of suspect cases of CJD referred to the CJD surveillance unit in Edinburgh and the number of deaths of definite and probable variant Creutzfeldt-Jakob disease [abbreviated in ProMED-mail as CJD (new var.) or vCJD], the form of the disease thought to be linked to BSE (bovine spongiform encephalopathy).

Definite and probable vCJD cases in the UK as of 1 Feb 2008 ----------------------------------------------------------- Summary of vCJD cases -- deaths ------------------------------------------- Deaths from definite vCJD (confirmed): 114 Deaths from probable vCJD (without neuropathological confirmation): 48 Deaths from probable vCJD (neuropathological confirmation pending): 1 Number of deaths from definite or probable vCJD (as above): 163

Summary of vCJD cases -- alive ------------------------------ Number of probable vCJD cases still alive: 3

Total ----- Number of definite or probable vCJD (dead and alive): 166

These data indicate that there have been no new cases diagnosed during the past month, and the number of patients alive is unchanged.

These data are still consistent with the view that the vCJD outbreak in the UK is in decline (although the incidence curve may be developing a tail). The peak number of deaths was 28 in the year 2000, followed by 20 in 2001, 17 in 2002, 18 in 2003, 9 in 2004, 5 in 2005, 5 in 2006, 5 in 2007, and so far none in 2008

Totals for all types of CJD cases in the year 2008 -------------------------------------------------- As of 1 Feb 2008 in the UK in the year 2008 so far there have been 9 referrals, 6 deaths from sporadic CJD, one death from iatrogenic CJD, none from familial CJD, none from GSS, and none from vCJD.

-- Communicated by: ProMED-mail

****** [2] UK: SEAC 99th meeting report Date: Thu 31 Jan 2008R (SEAC) Source: Spongiform Encephalopathy Advisory Committee (SEAC), 99th meeting, 14 Dec 2007 [edited]

Update on vCJD and sCJD epidemiology ------------------------------------ Dr Richard Knight (NCJDSU-National CJD Surveillance Unit) presented an update on the epidemiology of cases of sporadic CJD (sCJD) and vCJD in the UK and elsewhere. Between May 1990 and October 2007, 944 cases of sCJD had been identified in the UK with a mean age at onset of 66 (range 15-94) years and mean age of death of 67 (range 20-95) years. There is no significant gender difference in sCJD incidence. There had been a trend towards an increasing number of cases over time to almost 80 cases per year in 2003; this increased trend had also been observed in other countries and was considered to be a result of better surveillance and diagnosis of disease. There has been a decline in number since 2003, but this may not be of significance. The post mortem rate for sCJD referral is about 60 percent. The genotype distribution of sCJD cases was 64 percent MM, 18 percent MV and 18 percent VV at codon 129 of the prion protein gene.

Dr Knight explained that the total number of definite and probable vCJD cases in the UK up to November 2007 was 166, with 4 cases still alive. 3 out of 4 vCJD cases treated with pentosan polysulphate (PPS) had appreciably longer survival times, but it is not proven that this is the result of treatment. No statistically significant gender difference had been observed in vCJD cases. The age distribution of vCJD had not altered over the course of the UK epidemic, with the median age of death of 30 (range 14-75) years. Statistical analysis of the UK incidence of deaths from vCJD suggested the epidemic had peaked in 2000 with 28 deaths. There are 3 cases identified with onset in 2006 and four deaths in 2007. Geographical distribution of vCJD cases in the UK shows higher incidence in the North than South. All 146 vCJD cases tested to date are of the MM genotype [but see ProMED-mail Prion disease update 2008 (02) 20080107.0087 for a recent exception. - Mod.CP]

Dr Knight explained that elsewhere in the world up to November 2007, 39 vCJD cases have been reported with 23 in France, 4 in the Republic of Ireland (RoI), 3 in the USA, 2 in the Netherlands, 2 in Portugal and single cases in Italy, Canada, Japan, Saudi Arabia, and Spain.

Infection is considered likely to have occurred in the UK in 2 Ireland cases, 2 USA cases, and the single French, Japanese & Canadian cases. One of the French cases had a history of possibly significant residence in the UK. One USA case is thought likely to have been exposed to infection in Saudi Arabia, rather than the USA.

Dr Knight explained that the Transfusion Medicine Epidemiology Review study had identified 4 instances of vCJD infection resulting from receipt of non-leucodepleted [white cell reduced] red blood cells donated by individuals who had subsequently developed vCJD. The donors developed clinical vCJD ranging from 17 months to 3.5 years after blood donation and this indicates that blood can be infective 3.5 years before the development of clinical disease. Clinical vCJD was identified in 3 recipients (all of MM genotype) between 6.5 and 8.3 years after receipt of blood. The 4th recipient, who died of non-neurological disease, with only lymphoreticular evidence of vCJD infection, was of MV genotype.

In response to a question about the neuropathology of the vCJD case that died after receiving PPS, Dr Knight explained that no autopsy was undertaken.

A member asked about the reason for the increase in sCJD detection in the years up to 2003. Dr Knight replied that it was probably due to better awareness of the disease and the availability of better diagnostic methods such as cerebrospinal fluid testing and magnetic resonance imaging.

Mr Mark Noterman (Department of Health [DH]) asked whether the neuropathological referrals rate had increased after the Chief Medical Officer's letter to clinicians earlier in the year to remain vigilant about cases of neurological disease that could be related to prion disease. Dr Knight replied that there had been no subsequent significant increase in referral rate.

-- Communicated by: Terry S. Singeltary Sr.

****** [3] BASE transmission risk Date: Wed 30 Jan 2008 Source: Journal of Virology, Wed 20 Jan 2008 [edited]

Evaluation of the human transmission risk of an atypical bovine spongiform encephalopathy prion strain --------------------------------------------------------------- The following is the Abstract of a paper published in the Journal of Virology by Qingzhong Kong and colleagues at the Department of Pathology, Case Western Reserve University, Cleveland, Ohio 44106, USA; CEA [Centro di Referenza per le Encefalopatie Animali], and the Istituto Zooprofilattico Sperimentale, 10154 Torino, Italy; Department of Neurological and Visual Sciences, University of Verona, 37134 Verona, Italy.

"Bovine spongiform encephalopathy (BSE), the prion disease in cattle, was widely believed to have only one strain (BSE-C). BSE-C causes the fatal prion disease named new variant Creutzfeldt-Jacob [vCJD] disease in humans. Since 2004, 2 atypical BSE strains, BASE [bovine amyloidotic spongiform encephalopathy] (or BSE-L) and BSE-H, have been discovered in several countries ; their transmissibility and phenotypes in humans are unknown. We investigated the infectivity and human phenotype of BASE by inoculating transgenic (Tg) mice expressing the human prion protein with brain homogenates from 2 BASE-affected cattle. 60 percent of the inoculated Tg mice became infected after 20-22 months incubation, a transmission rate higher than those reported for BSE-C. A quarter of BASE-infected Tg mice, but none of the Tg mice infected with a sporadic human prion disease, showed presence of pathogenic prion protein isoforms in the spleen, indicating that the BASE prion is intrinsically lymphotropic. The pathological prion protein isoforms in BASE-infected humanized Tg mouse brains are different from those of the original cattle BASE or sporadic human prion disease. Minimal brain spongiosis and long incubation time are observed in the BASE-infected Tg mice. These results suggest that, in humans, BASE is a more virulent BSE strain and likely lymphotropic."

-- Communicated by: Terry S. Singeltary Sr.

[see also: Prion disease update 2008 (02) 20080107.0087 Prion disease update 2008 (01): correction 20080104.0046 Prion disease update 2008 (01) 20080102.0014 2007 ---- Prion disease update 2007 (08) 20071205.3923 Prion disease update 2007 (07) 20071105.3602 Prion disease update 2007 (06) 20071003.3269 Prion disease update 2007 (05) 20070901.2879 Prion disease update 2007 (04) 20070806.2560 Prion disease update 2007 (03) 20070702.2112 Prion disease update 2007 (02) 20070604.1812 Prion disease update 2007 20070514.1542 CJD (new var.) update 2007 (05) 20070403.1130 CJD (new var.) update 2007 (04) 20070305.0780 CJD (new var.) update 2007 (03) 20070205.0455 CJD (new var.) update 2007 (02): South Korea, susp 20070115.0199 2006 ---- CJD (new var.), blood transfusion risk 20061208.3468 CJD, transmission risk - Canada (ON) 20061207.3457 CJD (new var.) update 2006 (12) 20061205.3431 CJD (new var.) update 2006 (11) 20061106.3190 CJD (new var.) update 2006 (10) 20061002.2820 CJD (new var.) - Netherlands: 2nd case 20060623.1741 CJD (new var.) - UK: 3rd transfusion-related case 20060209.0432 CJD (new var.) update 2006 (02) 20060206.0386 CJD (new var.) update 2006 20060111.0101 2005 ---- CJD (new var.) update 2005 (12) 20051209.3547 CJD (new var.) update 2005 (11) 20051108.3270 CJD (new var.) update 2005 (10) 20051006.2916 CJD (new var.) update 2005 (02) 20050211.0467 CJD (new var.) - UK: update 2005 (01) 20050111.0095 2004 ---- CJD, genetic susceptibility 20041112.3064 CJD (new var.) - UK: update 2004 (14) 20041206.3242 CJD (new var.) - UK: update 2004 (10) 20040909.2518 CJD (new var.) - UK: update 2004 (02) 20040202.0400 CJD (new var.) - UK: update 2004 (01) 20040106.0064 CJD (new var.) - France: 8th case 20041022.2864 CJD (new var.) - France: 9th case 20041123.3138 CJD (new var.), blood supply - UK 20040318.0758 CJD (new var.), carrier frequency study - UK 20040521.1365 2003 ---- CJD (new var.) - UK: update 2003 (13) 20031216.3072 CJD (new var.) - UK: update 2003 (01) 20030108.0057 2002 ---- CJD (new var.) - UK: update Dec 2002 20021207.5997 CJD (new var.) - UK: update Jan 2002 20020111.3223 2001 ---- CJD (new var.), incidence & trends - UK (02) 20011124.2875 CJD (new var.), incidence & trends - UK 20011115.2816 CJD (new var.) - UK: reassessment 20011029.2671 CJD (new var.) - UK: update Oct 2001 20011005.2419 CJD (new var.) - UK: regional variation (02) 20010907.2145 CJD (new var.) - UK: update Sep 2001 20010906.2134 CJD (new var.) - UK: update Aug 2001 20010808.1872 CJD (new var.) - UK: 9th Annual Report 20010628.1231 CJD (new var.) - UK: update June 2001 20010622.1188 CJD (new var.) - UK: update 3 Jan 2001 20010104.0025] ........................................cp/mj/jw *##########################################################* ************************************************************ ProMED-mail makes every effort to verify the reports that are posted, but the accuracy and completeness of the information, and of any statements or opinions based thereon, are not guaranteed. The reader assumes all risks in using information posted or archived by ProMED-mail. ISID and its associated service providers shall not be held responsible for errors or omissions or held liable for any damages incurred as a result of use or reliance upon posted or archived material. ************************************************************ Become a ProMED-mail Premium Subscriber at

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[2] USA: National Prion Disease Pathology Surveillance Center Date: June 2007 Source: National Prion Disease Pathology Surveillance Center (USA) [edited]

CJD Cases examined ---------------------- Year / Referrals / Prion disease / Sporadic / Familial / Iatrogenic / vCJD

1996 / 42 / 32 / 26 / 4 / 0 / 0 1997 / 115 / 68 / 57 / 9 / 0 / 0 1998 / 93 / 53 / 45 / 7 / 1 / 0 1999 / 114 / 69 / 61 / 8 / 0 / 0 2000 / 151 / 103 / 89 / 14 / 0 / 0 2001 / 208 / 116 / 106 / 9 / 0 / 0 2002 / 255 / 143 / 118 / 23 / 2 / 0 2003 / 272 / 174 / 132 / 41 / 0 / 0 2004 / 334 / 183 / 157 / 21 / 0 / 1* 2005 / 352 / 195 / 152 / 37 / 1 / 0 2006 / 372 / 186 / 143 / 30 / 0 / 1** 2007 / 120 / 68 / 35 / 7 / 0 / 0 TOTAL / 2428*** / 1390**** / 1121 / 210 / 4 / 2

*Acquired in UK ** Acquired in Saudi Arabia *** Includes 17 inconclusive and 9 pending (1 from 2006, 8 from 2007. **** Includes 17 non-vCJD type unknown (2 from 1996, 2 from 1997, 1 from 2001, 1 from 2003, 4 from 2004, 3 from 2005, 4 from 2006) and 36 type pending (2 from 2005, 8 from 2006, 26 from 2007).


-- Cases are listed based on the year of death when available. If the year of death is not available, the year of sample receipt is used.

-- Referrals: Cases with possible or probable prion disease from which brain tissue or blood in the case of familial disease were submitted.

-- Inconclusive: Cases in which the samples were not sufficient to make a diagnosis.

-- Non-vCJD type unknown are cases in which the tissue submitted was adequate to establish the presence but not the type; in all cases, vCJD could be excluded.

-- Communicated by: Terry S. Singeltary Sr.

[In submitting these data, Terry S. Singeltary Sr. draws attention to the steady increase in the "type unknown" category, which, according to their definition, comprises cases in which vCJD could be excluded. The total of 26 cases for the current year (2007) is disturbing, possibly symptomatic of the circulation of novel agents. Characterization of these agents should be given a high priority. - Mod.CP],F2400_P1001_PUB_MAIL_ID:1010,39963

There is a growing number of human CJD cases, and they were presented last week in San Francisco by Luigi Gambatti(?) from his CJD surveillance collection.

He estimates that it may be up to 14 or 15 persons which display selectively SPRPSC and practically no detected RPRPSC proteins.

Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program - Phase II


Food Safety and Inspection Service

Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat Recovery Products - Phase III

Report No. 50601-10-KC January 2006

Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle Still Remain

Our prior report identified a number of inherent problems in identifying and testing high-risk cattle. We reported that the challenges in identifying the universe of high-risk cattle, as well as the need to design procedures to obtain an appropriate representation of samples, was critical to the success of the BSE surveillance program. The surveillance program was designed to target nonambulatory cattle, cattle showing signs of CNS disease (including cattle testing negative for rabies), cattle showing signs not inconsistent with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS condemned cattle were sampled and made a concerted effort for outreach to obtain targeted samples, industry practices not considered in the design of the surveillance program reduced assurance that targeted animals were tested for BSE.

In our prior report, we recommended that APHIS work with public health and State diagnostic laboratories to develop and test rabies-negative samples for BSE. This target group is important for determining the prevalence of BSE in the United States because rabies cases exhibit clinical signs not inconsistent with BSE; a negative rabies test means the cause of the clinical signs has not been diagnosed.

APHIS agreed with our recommendation and initiated an outreach program with the American Association of Veterinary Laboratory Diagnosticians, as well as State laboratories. APHIS also agreed to do ongoing monitoring to ensure samples were obtained from this target population.

Although APHIS increased the samples tested from this target group as compared to prior years, we found that conflicting APHIS instructions on the ages of cattle to test resulted in inconsistencies in what samples were submitted for BSE testing. Therefore, some laboratories did not refer their rabies negative samples to APHIS in order to maximize the number tested for this critical target population. In addition, APHIS did not monitor the number of submissions of rabies negative samples for BSE testing from specific laboratories.


An NVSL official stated that APHIS is not concerned with rabies negatives samples from cattle less than 30 months of age. This position, however, is contrary to APHIS' published target population.

Our prior audit recognized the significant challenge for APHIS to obtain samples from some high-risk populations because of the inherent problems with obtaining voluntary compliance and transporting the carcasses for testing. USDA issued rules to prohibit nonambulatory animals (downers) from entering the food supply at inspected slaughterhouses. OIG recommended, and the International Review Subcommittee33 emphasized, that USDA should take additional steps to assure that facilitated pathways exist for dead and nonambulatory cattle to allow for the collection of samples and proper disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS database documents 27,617 samples were collected showing a reason for submission of nonambulatory and 325,225 samples were collected with reason of submission showing "dead."

APHIS made extensive outreach efforts to notify producers and private veterinarians of the need to submit and have tested animals from these target groups. They also entered into financial arrangements with 123 renderers and other collection sites to reimburse them for costs associated with storing, transporting, and collecting samples. However, as shown in exhibit F, APHIS was not always successful in establishing agreements with non-slaughter collection sites in some States. APHIS stated that agreements do not necessarily reflect the entire universe of collection sites and that the presentation in exhibit F was incomplete because there were many collection sites without a payment involved or without a formal agreement. We note that over 90 percent of the samples collected were obtained from the 123 collection sites with agreements and; therefore, we believe agreements offer the best source to increase targeted samples in underrepresented areas.

We found that APHIS did not consider industry practices in the design of its surveillance effort to provide reasonable assurance that cattle exhibiting possible clinical signs consistent with BSE were tested. Slaughter facilities do not always accept all cattle arriving for slaughter because of their business requirements. We found that, in one State visited, slaughter facilities pre-screened and rejected cattle (sick/down/dead/others not meeting business

Downers and Cattle that Died on the Farm standards) before presentation for slaughter in areas immediately adjacent or contiguous to the official slaughter establishment. These animals were not inspected and/or observed by either FSIS or APHIS officials located at the slaughter facilities.

FSIS procedures state that they have no authority to inspect cattle not presented for slaughter. Further, APHIS officials stated they did not believe that they had the authority to go into these sorting and/or screening areas and require that the rejected animals be provided to APHIS for BSE sampling. Neither APHIS nor FSIS had any process to assure that animals left on transport vehicles and/or rejected for slaughter arrived at a collection site for BSE testing. FSIS allows slaughter facilities to designate the area of their establishment where federal inspection is performed; this is designated as the official slaughter establishment.34

We observed animals that were down or dead in pens outside the official premises that were to be picked up by renderers. Animals that were rejected by plant personnel were transported off the premises on the same vehicles that brought them to the plant.35

A policy statement36 regarding BSE sampling of condemned cattle at slaughter plants provided that effective June 1, 2004, FSIS would collect BSE samples for testing: 1) from all cattle regardless of age condemned by FSIS upon ante mortem inspection for CNS impairment, and 2) from all cattle, with the exception of veal calves, condemned by FSIS upon ante mortem inspection for any other reason.

FSIS Notice 28-04, dated May 20, 2004, informed FSIS personnel that, "FSIS will be collecting brain samples from cattle at federally-inspected establishments for the purpose of BSE testing." The notice further states that, "Cattle off-loaded from the transport vehicle onto the premises of the federally-inspected establishment (emphasis added), whether dead or alive, will be sampled by the FSIS Public Health Veterinarian (PHV) for BSE after the cattle have been condemned during ante mortem inspection. In addition, cattle passing ante mortem inspection but later found dead prior to slaughter will be condemned and be sampled by the FSIS PHV."

APHIS has the responsibility for sampling dead cattle off-loaded onto plant-owned property that is adjoining to, but not considered part of, the "official premises.37 FSIS procedures38 provide that "Dead cattle that are off-loaded to facilitate the off-loading of live animals, but that will be re-loaded onto the transport vehicle, are not subject to sampling by FSIS.

While performing our review in one State, we reviewed the circumstances at two slaughter facilities in the State that inspected and rejected unsuitable cattle before the animals entered the official receiving areas of the plants. This pre-screening activity was conducted in areas not designated by the facility as official premises of the establishment and not under the review or supervision of FSIS inspectors. The plant rejected all nonambulatory and dead/dying/sick animals delivered to the establishment. Plant personnel refused to offload any dead or downer animals to facilitate the offloading of ambulatory animals. Plant personnel said that the driver was responsible for ensuring nonambulatory animals were humanely euthanized and disposing of the carcasses of the dead animals. Plant personnel informed us that they did not want to jeopardize contracts with business partners by allowing unsuitable animals on their slaughter premises.

In the second case, one family member owned a slaughter facility while another operated a livestock sale barn adjacent to the slaughter facility. The slaughter facility was under FSIS' supervision while the sale barn was not. Cattle sometimes arrived at the sale barn that were sick/down/dead or would die or go down while at the sale barn. According to personnel at the sale barn, these animals were left for the renderer to collect. The healthy ambulatory animals that remained were marketed to many buyers including the adjacent slaughter facility. When the slaughter facility was ready to accept the ambulatory animals for processing, the cattle would be moved from the sale barn to the slaughter facility where they were subject to FSIS' inspection.

We requested the slaughter facilities to estimate the number of cattle rejected on a daily basis (there were no records to confirm the estimates). We visited a renderer in the area and found that the renderer had a contract with APHIS to collect samples for BSE testing. In this case, although we could not obtain assurance that all rejected cattle were sampled, the renderer processed a significant number of animals, as compared to the slaughter plants' estimates of those rejected. Due to the close proximity (less than 5 miles) of the renderer to the slaughter facilities, and the premium it paid for dead cattle that were in good condition, there was a financial incentive for transport drivers to dispose of their dead animals at this renderer.

USDA/OIG-A/50601-10-KC Page 25

In our discussions with APHIS officials in Wisconsin and Iowa, they confirmed that there were plants in their States that also used pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to provide a list of all slaughter facilities that pre-screened cattle for slaughter in locations away from the area designated as the official slaughter facility. Along with this request, we asked for information to demonstrate that either APHIS or FSIS confirmed there was a high likelihood that high-risk animals were sampled at other collection sites.

In response to our request, the APHIS BSE Program Manager stated that APHIS did not have information on slaughter plants that pre-screen or screen their animals for slaughter suitability off their official plant premises. To their knowledge, every company or producer that submits animals for slaughter pre-sorts or screens them for suitability at various locations away from the slaughter facility. For this reason, USDA focused its BSE sample collection efforts at other types of facilities such as renderers, pet food companies, landfills, and dead stock haulers. Further, in a letter to OIG on June 14, 2005, the administrators of APHIS and FSIS noted the following:

".we believe that no specific actions are necessary or appropriate to obtain reasonable assurance that animals not presented for slaughter are being tested for BSE. There are several reasons for our position. First, we do not believe that the practice is in fact causing us to not test a significant enough number of animals in our enhanced surveillance program to invalidate the overall results. Second, OIG has concluded that because of the geographical proximity and business relationships of the various entities involved in the case investigated, there is reasonable assurance that a majority of the rejected cattle had been sampled. Third, it is also important to remember that the goal of the enhanced surveillance program is to test a sufficient number of animals to allow us to draw conclusions about the level of BSE (if any) in the American herd.We believe that the number we may be not testing because of the "pre-sorting" practice does not rise to a significant level. The number of animals tested to date has far exceeded expectations, so it is reasonable to infer that there are few of the animals in question, or that we are testing them at some other point in the process.APHIS estimated.there were approximately 446,000 high risk cattle.[and APHIS has].tested over 375,000 animals in less than 1 year. This indicated that we are missing few animals in the high-risk population, including those that might be pre-sorted before entering a slaughter facility's property."


APHIS notes that for the current surveillance program, it had established regional goals and APHIS was not trying to meet particular sampling levels in particular States. However, we believe that it would be advantageous for APHIS to monitor collection data and increase outreach when large geographical areas such as the above States do not provide samples in proportion to the numbers and types of cattle in the population.

We also disagree with APHIS/FSIS' contention that because they have tested over 375,000 of their 446,000 estimate of high risk cattle, few in the high-risk population are being missed, including those that might be pre-screened before entering a slaughter facility's property. In our prior audit, we reported that APHIS underestimated the high-risk population; we found that this estimate should have been closer to 1 million animals (see Finding 1). We recognize that BSE samples are provided on a voluntary basis; however, APHIS should consider industry practice in any further maintenance surveillance effort. Animals unsuitable for slaughter exhibiting symptoms not inconsistent with BSE should be sampled and their clinical signs recorded. However, this cited industry practice results in rejected animals not being made available to either APHIS or FSIS veterinarians for their observation and identification of clinical signs exhibited ante mortem. Although these animals may be sampled later at other collection sites, the animals are provided post mortem without information as to relevant clinical signs exhibited ante mortem. For these reasons, we believe APHIS needs to

USDA/OIG-A/50601-10-KC Page 27

observe these animals ante mortem when possible to assure the animals from the target population are ultimately sampled and the clinical signs evaluated.


[Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE)

APHIS-2006-0041-0006 TSE advisory committee for the meeting December 15, 2006

Attachment to Singeltary comment

January 28, 2007

Greetings APHIS,

I would kindly like to submit the following to ;


[Federal Register: January 9, 2007 (Volume 72, Number 5)] [Proposed Rules] [Page 1101-1129] From the Federal Register Online via GPO Access [] [DOCID:fr09ja07-21]


Thursday, January 31, 2008

Evaluation of the Human Transmission Risk of an Atypical Bovine Spongiform Encephalopathy Prion Strain

J. Virol. doi:10.1128/JVI.02561-07 Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Evaluation of the Human Transmission Risk of an Atypical Bovine Spongiform Encephalopathy Prion Strain

Qingzhong Kong*, Mengjie Zheng, Cristina Casalone, Liuting Qing, Shenghai Huang, Bikram Chakraborty, Ping Wang, Fusong Chen, Ignazio Cali, Cristiano Corona, Francesca Martucci, Barbara Iulini, Pierluigi Acutis, Lan Wang, Jingjing Liang, Meiling Wang, Xinyi Li, Salvatore Monaco, Gianluigi Zanusso, Wen-Quan Zou, Maria Caramelli, and Pierluigi Gambetti* Department of Pathology, Case Western Reserve University, Cleveland, OH 44106, USA; CEA, Istituto Zooprofilattico Sperimentale, 10154 Torino, Italy; Department of Neurological and Visual Sciences, University of Verona, 37134 Verona, Italy

* To whom correspondence should be addressed. Email:



These results suggest that, in humans, BASE is a more virulent BSE strain and likely lymphotropic.



Thursday, January 31, 2008

SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE Draft minutes of the 99th meeting held on 14th December 2007



40. The Chair explained that the purpose of the question and answer session was to give members of the public an opportunity to ask questions related to the work of SEAC. Mr Terry Singeltary (Texas, USA) had submitted a question prior to the meeting, asking: "With the Nor-98 now documented in five different states so far in the USA in 2007, and with the two atypical BSE H-base

13 © SEAC 2007

cases in Texas and Alabama, with both scrapie and chronic wasting disease (CWD) running rampant in the USA, is there any concern from SEAC with the rise of sporadic CJD in the USA from ''unknown phenotype'', and what concerns if any, in relations to blood donations, surgery, optical, and dental treatment, do you have with these unknown atypical phenotypes in both humans and animals in the USA? Does it concern SEAC, or is it of no concern to SEAC? Should it concern USA animal and human health officials?"

41. A member considered that this question ............

snip... please see full text, sources, and comments here ;


Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States

Creutzfeldt Jakob Disease

Creutzfeldt-Jakob Disease, Prion Protein Gene Codon 129VV, and a Novel PrPSc Type in a Young British Woman




Friday, January 11, 2008


Friday, January 25, 2008 January 2008 Update on Feed Enforcement Activities to Limit the Spread of BSE




MARCH 26, 2003

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States

Email Terry S. Singeltary:

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009

August 10, 2009


I would like to submit a review of past CJD surveillance in the USA, and the urgent need to make all human TSE in the USA a reportable disease, in every state, of every age group, and to make this mandatory immediately without further delay. The ramifications of not doing so will only allow this agent to spread further in the medical, dental, surgical arena's. North America seems to have the most species with documented Transmissible Spongiform Encephalopathy's, most all of which have been rendered and fed back to food producing animals and to humans for years. If you look at the statistics, sporadic CJD seems to be rising in the USA, and has been, with atypical cases of the sCJD. I find deeply disturbing in the year of 2009, that Human Transmissible Spongiform Encephalopathy of any strain and or phenotype, of all age groups, and I stress all age groups, because human TSE's do not know age, and they do not know borders. someone 56 years old, that has a human TSE, that has surgery, can pass this TSE agent on i.e. friendly fire, and or passing it forward, and there have been documented nvCJD in a 74 year old. Remembering also that only sporadic CJD has been documented to transmit via iatrogenic routes, until recently with the 4 cases of blood related transmission, of which the origin is thought to be nvCJD donors. However most Iatrogenic CJD cases are nothing more than sporadic CJD, until the source is proven, then it becomes Iatrogenic. An oxymoron of sorts, because all sporadic CJD is, are multiple forms, or strains, or phenotypes of Creutzfeldt Jakob Disease, that the route and source and species have not been confirmed and or documented. When will the myth of the UKBSEnvCJD only theory be put to bed for good. This theory in my opinion, and the following there from, as the GOLD STANDARD, has done nothing more than help spread this agent around the globe. Politics and money have caused the terrible consequences to date, and the fact that TSEs are a slow incubating death, but a death that is 100% certain for those that are exposed and live long enough to go clinical. once clinical, there is no recourse, to date. But, while sub-clinical, how many can one exposed human infect? Can humans exposed to CWD and scrapie strains pass it forward as some form of sporadic CJD in the surgical and medical arenas? why must we wait decades and decades to prove this point, only to expose millions needlessly, only for the sake of the industries involved? would it not have been prudent from the beginning to just include all TSE's, and rule them out from there with transmission studies and change policies there from, as opposed to doing just the opposite? The science of TSE's have been nothing more than a political circus since the beginning, and for anyone to still believe in this one strain, one group of bovines, in one geographical location, with only one age group of human TSE i.e. nvCJD myth, for anyone to believe this today only enhances to spreading of these human and animal TSE's. This is exactly why we have been in this quagmire.

The ones that believe that there is a spontaneous CJD in 85%+ of all cases of human TSE, and the ones that do not believe that cattle can have this same phenomenon, are two of the same, the industry, and so goes the political science aspect of this tobacco and or asbestos scenario i.e. follow the money. I could go into all angles of this man made nightmare, the real facts and science, for instance, the continuing rendering technology and slow cooking with low temps that brewed this stew up, and the fact that THE USA HAD THIS TECHNOLOGY FIRST AND SHIPPED IT TO THE U.K. SOME 5 YEARS BEFORE THE U.S. STARTED USING THE SAME TECHNOLOGY, to save on fuel cost. This is what supposedly amplified the TSE agent via sheep scrapie, and spread via feed in the U.K. bovine, and other countries exporting the tainted product. BUT most everyone ignores this fact, and the fact that the U.S. has been recycling more TSE, from more species with TSEs, than any other country documented, but yet, it's all spontaneous, and the rise in sporadic CJD in the U.S. is a happenstance of bad luck ??? I respectfully disagree. To top that all off, the infamous BSE-FIREWALL that the USDA always brags about was nothing more than ink on paper, and I can prove this. YOU can ignore it, but this is FACT (see source, as late as 2007, in one recall alone, some 10,000,000 MILLION POUNDS OF BANNED MAD COW FEED WENT OUT INTO COMMERCE TO BE FED OUT, and most was never recovered. This was banned blood laced, meat and bone meal. 2006 was a banner year for banned mad cow protein going into commerce in the U.S. (see source of FDA feed ban warning letter below). I stress that the August 4, 1997 USA mad cow feed ban and this infamous BSE firewall, was nothing more than ink on paper, it was never enforceable.

I propose that the current diagnostic criteria for human TSEs only enhances and helps the spreading of human TSE from the continued belief of the UKBSEnvCJD only theory in 2009. With all the science to date refuting it, to continue to validate this old myth, will only spread this TSE agent through a multitude of potential routes and sources i.e. consumption, medical i.e., surgical, blood, dental, endoscopy, optical, nutritional supplements, cosmetics etc. I propose as with Aguzzi, Asante, Collinge, Caughey, Deslys, Dormont, Gibbs, Gajdusek, Ironside, Manuelidis, Marsh, et al and many more, that the world of TSE Transmissible Spongiform Encephalopathy is far from an exact science, but there is enough proven science to date that this myth should be put to rest once and for all, and that we move forward with a new classification for human and animal TSE that would properly identify the infected species, the source species, and then the route. This would further have to be broken down to strain of species and then the route of transmission would further have to be broken down. Accumulation and Transmission are key to the threshold from sub- clinical to clinical disease, and key to all this, is to stop the amplification and transmission of this agent, the spreading of, no matter what strain. In my opinion, to continue with this myth that the U.K. strain of BSE one strain TSE in cows, and the nv/v CJD one strain TSE humans, and the one geographical location source i.e. U.K., and that all the rest of human TSE are just one single strain i.e. sporadic CJD, a happenstance of bad luck that just happens due to a twisted protein that just twisted the wrong way, IN 85%+ OF ALL HUMAN TSEs, when to date there are 6 different phenotypes of sCJD, and growing per Gambetti et al, and that no other animal TSE transmits to humans ??? With all due respect to all Scientist that believe this, I beg to differ. To continue with this masquerade will only continue to spread, expose, and kill, who knows how many more in the years and decades to come. ONE was enough for me, My Mom, hvCJD i.e. Heidenhain Variant CJD, DOD 12/14/97 confirmed, which is nothing more than another mans name added to CJD, like CJD itself, Jakob and Creutzfeldt, or Gerstmann-Straussler-Scheinker syndrome, just another CJD or human TSE, named after another human. WE are only kidding ourselves with the current diagnostic criteria for human and animal TSE, especially differentiating between the nvCJD vs the sporadic CJD strains and then the GSS strains and also the FFI fatal familial insomnia strains or the ones that mimics one or the other of those TSE? Tissue infectivity and strain typing of the many variants of the human and animal TSEs are paramount in all variants of all TSE. There must be a proper classification that will differentiate between all these human TSE in order to do this. With the CDI and other more sensitive testing coming about, I only hope that my proposal will some day be taken seriously. ...

please see history, and the ever evolving TSE science to date ;

Saturday, June 13, 2009

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009

Thursday, November 05, 2009

Incidence and spectrum of sporadic Creutzfeldt-Jakob disease variants with mixed phenotype and co-occurrence of PrPSc types: an updated classification

Tuesday, August 11, 2009

Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants

Brian S. Appleby, MD; Kristin K. Appleby, MD; Barbara J. Crain, MD, PhD; Chiadi U. Onyike, MD, MHS; Mitchell T. Wallin, MD, MPH; Peter V. Rabins, MD, MPH

Background: The classic Creutzfeldt-Jakob disease (CJD), Heidenhain, and Oppenheimer-Brownell variants are sporadic CJD (sCJD) phenotypes frequently described in the literature, but many cases present with neuropsychiatric symptoms, suggesting that there may be additional sCJD phenotypes.

Objective: To characterize clinical, diagnostic, and molecular features of 5 sCJD variants.

Design: Retrospective analysis.

Setting: The Johns Hopkins and Veterans Administration health care systems.

Participants: Eighty-eight patients with definite or probable sCJD.

Main Outcome Measures: Differences in age at onset, illness progression, diagnostic test results, and molecular subtype.

Results: The age at onset differed among sCJD variants (P=.03); the affective variant had the youngest mean age at onset (59.7 years). Survival time (P.001) and the time to clinical presentation (P=.003) differed among groups. Patients with the classic CJD phenotype had the shortest median survival time from symptom onset (66 days) and those who met criteria for the affective sCJD variant had the longest (421 days) and presented to clinicians significantly later (median time from onset to presentation, 92 days; P=.004). Cerebrospinal fluid analyses were positive for 14-3-3 protein in all of the affective variants, regardless of illness duration. Periodic sharp-wave complexes were not detected on any of the electroencephalography tracings in the Oppenheimer-Brownell group; basal ganglia hyperintensity was not detected on brain magnetic resonance imaging in this group either. All of the Heidenhain variants were of the methionine/ methionine type 1 molecular subtype.

Conclusions: The classic CJD phenotype and the Heidenhain, Oppenheimer-Brownell, cognitive, and affective sCJD variants differ by age at disease onset, survival time, and diagnostic test results. Characteristics of these 5 phenotypes are provided to facilitate further clinicopathologic investigation that may lead to more reliable and timely diagnoses of sCJD.

Arch Neurol. 2009;66(2):208-215



snip...see full text ;


Hardcover, 304 pages plus photos and illustrations. ISBN 0-387-95508-9

June 2003

BY Philip Yam


Answering critics like Terry Singeltary, who feels that the U.S. under- counts CJD, Schonberger conceded that the current surveillance system has errors but stated that most of the errors will be confined to the older population.

doi:10.1016/S1473-3099(03)00715-1 Copyright © 2003 Published by Elsevier Ltd. Newsdesk

Tracking spongiform encephalopathies in North America

Xavier Bosch

Available online 29 July 2003. Volume 3, Issue 8, August 2003, Page 463

"My name is Terry S Singeltary Sr, and I live in Bacliff, Texas. I lost my mom to hvCJD (Heidenhain variant CJD) and have been searching for answers ever since. What I have found is that we have not been told the truth. CWD in deer and elk is a small portion of a much bigger problem." ...

vCJD transfusion-associated Fourth Case UK

risk factors for sporadic CJD

Prominent and Persistent Extraneural Infection in Human PrP Transgenic Mice Infected with Variant CJD

PDF]Freas, William TSS SUBMISSION File Format: PDF/Adobe Acrobat -Page 1. J Freas, William From: Sent: To: Subject: Terry S. SingeltarySr. [] Monday, January 08,200l 3:03 PM freas ...

Asante/Collinge et al, that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest _sporadic_ CJD;

DER SPIEGEL (9/2001) - 24.02.2001 (9397 Zeichen)USA: Loch in der MauerDie BSE-Angst erreicht Amerika: Trotz strikter Auflagen gelangte in Texas verbotenes Tiermehl ins Rinderfutter - die Kontrollen der Aufsichtsbehördensind lax.Link auf diesen Artikel im Archiv:

"Its as full of holes as Swiss Cheese" says Terry Singeltary of the FDA regulations. ...

Thu Dec 6, 2007 11:38



2 January 2000

British Medical Journal

U.S. Scientist should be concerned with a CJD epidemic in the U.S., as well

15 November 1999

British Medical Journal

vCJD in the USA * BSE in U.S.


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Friday, September 4, 2009

FOIA REQUEST ON FEED RECALL PRODUCT 429,128 lbs. feed for ruminant animals may have been contaminated with prohibited material Recall # V-258-2009

Saturday, August 29, 2009

FOIA REQUEST FEED RECALL 2009 Product may have contained prohibited materials Bulk Whole Barley, Recall # V-256-2009

----- Original Message ----- From: "Terry S. Singeltary Sr." To: Sent: Thursday, November 05, 2009 9:25 PM Subject: [BSE-L] re-FOIA REQUEST ON FEED RECALL PRODUCT contaminated with prohibited material Recall # V-258-2009 and Recall # V-256-2009

thank you,

kindest regards,

I am sincerely,

Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518

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