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From: TSS ()
Subject: TRANSCRIPT: Technical Briefing - Hallmark/Westland Meat Packing Company - (02/21/08)
Date: February 21, 2008 at 6:42 pm PST


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.

REPORTER: Okay.

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.

REPORTER: Okay.

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?

OPERATOR: Yes.

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.



http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2008/02/0054.xml


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.


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. ...

http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2008/02/0046.xml

>>>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. <<<


10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA
2007


Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling's 85% Blood Meal, Flash Dried,
Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI

___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL
Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal,
TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY
Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST
POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI - 8# SPECIAL
DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J - PROTEIN/LACTATION, ROCK
CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC
MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY,
A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with
commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm
initiated recall is complete.
REASON
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.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007


http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html


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


http://madcowspontaneousnot.blogspot.com/2008/02/specified-risk-materials-srm.html

Geographical BSE Risk (GBR) assessments covering 2000-2006

Date : 01.08.2006

http://www.efsa.europa.eu/EFSA/Scientific_Document/GBR_assessments_table_Overview_assessed_countries_2002-2006.pdf


USDA CERTIFIED H-BASE MAD COW SCHOOL LUNCH PROGRAM


http://cjdmadcowbaseoct2007.blogspot.com/2008/02/usda-certified-h-base-mad-cow-school.html


http://tinyurl.com/yul2lw


[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

http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf


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


http://cjdmadcowbaseoct2007.blogspot.com/2008/02/release-no-004608-statement-by.html


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


http://www.usda.gov/oig/webdocs/sarc070619.pdf


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.

http://www.fsis.usda.gov/Fact_Sheets/Bovine_Spongiform_Encephalopathy_Mad_Cow_Disease/index.asp

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.


http://digital.library.unt.edu/govdocs/crs/permalink/meta-crs-10052:1

Emergency Management and Information NetworkPennsylvania Department of
Agriculture Bureau of Animal Health and Diagnostic Services John I. Enck,
Jr., V.M.D., Director c-animalem@state.pa.us 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.


http://ucce.ucdavis.edu/files/filelibrary/1808/12778.pdf

TEXAS SUSPECT MAD COW DOWNER RENDERED WITH NO TEST 2004

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).

http://www.fda.gov/bbs/topics/news/2004/NEW01061.html

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...

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

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 ;

http://jama.ama-assn.org/cgi/content/full/291/5/553?etoc


SEE VIDEO AGAIN OF HIGHLY SUSPECT MAD COW BEEF FOR THAT SCHOOL LUNCH PROGRAM
IN 35+ STATES,

http://tinyurl.com/yul2lw


kinda reminds you of these mad cows ;

http://msnbcmedia2.msn.com/j/msnbc/Components/Video/031231/nn_baz_madcow_031231.300w.jpg

http://www.cbc.ca/gfx/pix/mad_cow_usda_file.jpg

http://blog.erdener.org/archives/images/20031223-madcow.jpg

SCRAPIE PROGRAM FY REPORT 2007


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


snip...


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). ...


snip...


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.


snip...

see full report here ;

http://www.aphis.usda.gov/animal_health/animal_diseases/scrapie/downloads/yearly_report.pps

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. ...


http://www.newscientist.com/article/mg16922840.300-like-lambs-to-the-slaughter.html


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.
http://www.foodstandards.gov.uk/multimedia/pdfs/fsa041204.pdf

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?

SEAC SHEEP SUBGROUP
POSITION STATEMENT


http://www.seac.gov.uk/pdf/positionstatement-sheep-subgroup.pdf


NOR-98 ATYPICAL SCRAPIE USA UPDATE AS AT OCT 2007

http://nor-98.blogspot.com/


SCRAPIE USA

http://scrapie-usa.blogspot.com/


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

http://jama.ama-assn.org/cgi/content/extract/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

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


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8

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

http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


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]
tml>


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
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A ProMED-mail post


snip...

[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).

Notes:

-- 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]


http://www.promedmail.org/pls/askus/f?p=2400:1001:6833194127530602005::NO::F2400_P1001_BACK_PAGE,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.


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/1006-4240t1.htm


http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4240t1.pdf

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.

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.


snip...


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."


snip...


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.

snip...

http://www.usda.gov/oig/webdocs/50601-10-KC.pdf

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


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf


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


http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064801f3413&disposition=attachment&contentType=msw8


Attachment to Singletary comment

January 28, 2007


Greetings APHIS,


I would kindly like to submit the following to ;


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS DERIVED FROM BOVINES
[Docket No. APHIS-2006-0041] RIN 0579-AC01


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


http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f8152


BSE; MRR; IMPORTATION OF LIVE BOVINES AND PRODUCTS
DERIVED FROM BOVINES [Docket No. APHIS-2006-0041] RIN 0579-AC01
Date: January 9, 2007 at 9:08 am PST


http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=09000064801f3412

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: qxk2@case.edu.
pxg13@case.edu.


Abstract


snip...

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

snip...


SEE FULL TEXT ;


http://jvi.asm.org/cgi/content/abstract/JVI.02561-07v1?papetoc

http://cjdmadcowbaseoct2007.blogspot.com/2008/01/evaluation-of-human-transmission-risk.html

http://cjdmadcowbaseoct2007.blogspot.com/

Thursday, January 31, 2008

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


snip...


ITEM 8 - PUBLIC QUESTION AND ANSWER SESSION


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 ;


http://seac992007.blogspot.com/2008/01/spongiform-encephalopathy-advisory.html


CJD TEXAS

http://cjdtexas.blogspot.com/


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

http://cjdusa.blogspot.com/


Creutzfeldt Jakob Disease

http://creutzfeldt-jakob-disease.blogspot.com/


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


http://creutzfeldt-jakob-disease.blogspot.com/2008/01/creutzfeldt-jakob-disease-prion-protein.html


CJD QUESTIONNAIRE

http://cjdquestionnaire.blogspot.com/


ANIMAL HEALTH REPORT 2006 (BSE h-BASE EVENT IN ALABAMA, Scrapie, and CWD)

http://animalhealthreport2006.blogspot.com/


CREUTZFELDT JAKOB DISEASE MAD COW BASE UPDATE USA

http://cjdmadcowbaseoct2007.blogspot.com/


Friday, January 11, 2008

CJD HUMAN TSE REPORT UK, USA, CANADA, and Mexico JANUARY 2008


http://cjdmadcowbaseoct2007.blogspot.com/2008/01/cjd-human-tse-report-uk-usa-canada-and.html


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

http://madcowspontaneousnot.blogspot.com/2008/01/january-2008-update-on-feed-enforcement.html

http://madcowspontaneousnot.blogspot.com/


BSE BASE MAD COW TESTING TEXAS, USA, AND CANADA

http://madcowtesting.blogspot.com/


NOR-98 ATYPICAL SCRAPIE USA UPDATE AS AT OCT 2007

http://nor-98.blogspot.com/

http://scrapie-usa.blogspot.com/


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


http://jama.ama-assn.org/cgi/content/extract/285/6/733?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=singeltary&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT


JOURNAL OF NEUROLOGY

MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob

disease in the United States

Email Terry S. Singeltary:

flounder@wt.net

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?

http://www.neurology.org/cgi/eletters/60/2/176#535


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

June 2003

BY Philip Yam


CHAPTER 14 LAYING ODDS

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.

http://www.thepathologicalprotein.com/


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." ...


http://www.thelancet.com/journals/laninf/article/PIIS1473309903007151/fulltext

http://download.thelancet.com/pdfs/journals/1473-3099/PIIS1473309903007151.pdf


vCJD transfusion-associated Fourth Case UK

http://vcjdtransfusion.blogspot.com/


risk factors for sporadic CJD

http://creutzfeldt-jakob-disease.blogspot.com/2008/01/risk-factors-for-sporadic-creutzfeldt.html


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

http://creutzfeldt-jakob-disease.blogspot.com/2008/01/creutzfeldt-jakob-disease-prion-protein.html


BSE (Mad Cow) Update: Do Reports of sCJD Clusters Matter?

snip... see full text ;

http://cjdtexas.blogspot.com/


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

http://cjdusa.blogspot.com/


Creutzfeldt Jakob Disease

http://creutzfeldt-jakob-disease.blogspot.com/


CJD QUESTIONNAIRE

http://cjdquestionnaire.blogspot.com/


ANIMAL HEALTH REPORT 2006 (BSE h-BASE EVENT IN ALABAMA, Scrapie, and CWD)

http://animalhealthreport2006.blogspot.com/


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

http://cjdmadcowbaseoct2007.blogspot.com/2008/01/prominent-and-persistent-extraneural.html

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

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf


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;

http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm


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:http://service.spiegel.de/digas/find?DID=18578755


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


http://service.spiegel.de/digas/servlet/find/DID=18578755


Thu Dec 6, 2007 11:38

FDA IN CRISIS MODE, AMERICAN LIVES AT RISK


http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html


FDA SCIENCE AND MISSION AT RISK

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

2 January 2000

British Medical Journal

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

http://www.bmj.com/cgi/eletters/320/7226/8/b#6117


15 November 1999

British Medical Journal

vCJD in the USA * BSE in U.S.


http://www.bmj.com/cgi/eletters/319/7220/1312/b#5406

thank you,

kindest regards,

I am sincerely,

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






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