##################### Bovine Spongiform Encephalopathy #####################
Name: TSS 2005
E-Mail:
[email protected]
Subject: FSIS Notices 54-05, Policy on Use of Results from Third Party Laboratories (Fong Effect)
Body of Message:
FSIS NOTICE
54-05
8/29/05
POLICY ON USE OF RESULTS FROM THIRD PARTY LABORATORIES
NOTE: This notice reissues the contents of FSIS Notice 52-03 in its entirety.
PURPOSE
FSIS is periodically presented with positive results from a laboratory analysis conducted by a third party laboratory that indicate an adulterant is present in FSIS inspected and passed product. A third party laboratory is one not owned by, nor under contract with, the establishment providing the sample. Under very limited circumstances, FSIS may rely on a third party laboratory's positive result to take action on the product (e.g., request a recall or take regulatory action). This notice describes the circumstances in which FSIS considers it appropriate to rely on results from a third party laboratory.
POLICY ON THIRD PARTY LABORATORY RESULTS
In deciding whether to rely on third party laboratory results, FSIS will consider the following questions (also see attached flowchart (PDF only)):
Were the procedures used to collect, handle, and transport the sample equivalent to FSIS procedures? FSIS will request documentation of the procedures used and will assess whether the integrity of the sample or specimen could have been compromised during collection or transportation.
Was the sample or specimen handled using a documented chain of custody establishing that the integrity of the sample or specimen was not compromised during transport from the point of collection to the laboratory or within the laboratory? FSIS will assess the documentation of the chain of custody to determine whether the people who handled the sample kept it intact and properly maintained throughout the process.
Was there assurance that the results obtained by the third party laboratory are reliable and accurate for the analysis in question? FSIS will assess the available information about the laboratory (e.g., whether the laboratory is accredited under the International Organization for Standardization Standard 17025 (ISO 17025) and whether the analysis was performed in accordance with that accreditation) to determine whether the Agency can confidently rely on the laboratory's results.
Was the sample or specimen analyzed in accordance with documented analytical methodology that has a sensitivity and specificity that are determined by FSIS to be equivalent to the FSIS laboratory methodology in question?
If the Agency finds that the answers to the four questions listed are "yes", FSIS would consider that there is an appropriate basis to rely on the results of the analysis by the third party laboratory. Thus, FSIS would be prepared to take action (e.g., request a recall or institute a regulatory action) on the basis of the results obtained by the third party laboratory.
If the Agency finds that the answer to number 1 or number 2 is "no" or "inconclusive", then the sample result is disregarded. If the answer to number 1 and number 2 is "yes", then FSIS considers the laboratory's results in the following manner:
If the answer to number 3 is "yes" and the answer to number 4 is "no", then FSIS will take a verification sample;
If the answer to number 3 is "no" and the answer to number 4 is "no" then FSIS will disregard the sample results; and,
If the answer to number 3 is "no" and the answer to number 4 is "yes" then FSIS will take a verification sample.
When taking verification samples, FSIS will make an effort, whenever possible, to collect an intact sample of the same exact product and lot code(s) from the same location at which the third party sample was collected.
NOTE: Even without reliable laboratory results, FSIS may decide on the basis of the available epidemiological and other evidence that there is reason to find that product is adulterated and, thus, to act against that product.
Philip S. Derfler /s/
http://www.fsis.usda.gov/regulations_&_policies/Notice_54-05/index.asp
FSIS NOTICE 54-05
Decision Tree on Third Party Laboratory
Results FSIS receives lab result and
contacts the laboratory for the
following information
Is sample collection procedure documented,
followed and equivalent to FSIS?
Yes No
Is sample chain of custody OK? Disregard Results No
Yes
party laboratory are reliable and accurate for the analysis
in question?
Yes No
Are the sample analysis
procedures and performance
characteristics documented and
equivalent to FSIS?
Are the sample analysis
procedures and performance
characteristics documented and
equivalent to FSIS?
Yes No Yes No
Treat the sample result
as if it were an FSIS
laboratory sample result
Disregard Results
Collect a verification
sample for the FSIS
laboratory
Was there assurance that the results obtained by the third
http://www.fsis.usda.gov/oppde/rdad/fsisnotices/54-05_flowchart.pdf
Release No. 0280.05
Contact:
Office of Communications (202)720-4623
Technical Briefing With Dr. John Clifford, USDA Chief Veterinary Officer, Animal and Plant Health Inspection Service Update On BSE Surveillance Testing Washington, DC--July 27, 2005
OPERATOR: "Good afternoon, and thank you, all parties, for holding. Your lines have been placed on listen-only until the question and answer session. At the time of the questions please press *1. You'll be asked to state your name and affiliation. Please limit your questions to one only please. I'll now turn the call over to Mr. Jim Rogers. You may begin, sir."
JIM ROGERS: "Hello, everyone. This is Jim Rogers of APHIS, USDA. I just want to thank you all for joining us today on a regular weekday during normal business hours, unlike some of the other ones that we tend to do.
"I have with me today USDA Chief Veterinarian Dr. John Clifford. He is going to be reading a brief statement, after which we will do a brief question and answer period.
"Dr. Clifford?"
DR. JOHN CLIFFORD: "Thank you, Jim. And thanks again for joining us this afternoon.
"Late yesterday we received non-definitive test results on an animal sampled as part of our voluntary extension of our enhanced BSE surveillance program. USDA is conducting further testing at our National Veterinary Services Laboratory in Ames, Iowa, in consultation with experts from the International Reference Laboratory in Weybridge, England. We are also sending samples from this animal to the Weybridge Laboratory for further testing. It is important to note that this animal poses no threat to our food supply because it did not enter the human food or animal feed chains.
"The sample was submitted to us by a private veterinarian. As an extension of our enhanced surveillance program, accredited private veterinarians who often visit farms in remote areas collect samples when warranted. The sample in question today was taken from a cow that was at least 12 years of age and experienced complications during calving.
"The veterinarian treated the sample with a preservative which readies it for testing using the immunohistochemistry test, an internationally recognized confirmatory test for BSE.
"Neither the rapid screening test nor the Western blot confirmatory test can be conducted on a sample that has been preserved. Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing.
"As we have previously experienced, it is possible for an IHC test to yield differing results, depending on the slice of tissue that is tested. Therefore scientists at our laboratory and at Weybridge will run the IHC test on additional slices of tissue from this animal to determine whether or not it was infected with BSE.
"We will announce results as soon as they are compiled, which we expect to occur by next week.
"I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used. The sample was not submitted to us until last week because the veterinarian set aside the sample after preserving it and simply forgot to send it in.
"On that point I would like to emphasize, while that time lag is not optimal it has no implications in terms of the risk to human health. The carcass of this animal was destroyed. Therefore there is absolutely no risk to human or animal health from this animal.
"Regardless of the outcome of further testing, I want to emphasize that human and animal health in the United States are protected by a system of interlocking safeguards. The most important of these is the ban on specified risk materials from food supply. And by any measure the incidence of BSE in this country is extremely low.
"Our enhanced surveillance program is designed to provide information about the level of prevalence of BSE in the United States. We are extremely gratified that to date all sectors of the cattle industry have cooperated in this program by submitting samples from more than 419,000 animals from the highest-risk population.
"To date only one animal has tested positive for the disease as part of the surveillance program.
"The interlocking safeguards continue to protect our food supply. Those safeguards include most notably the removal of specified risk materials from animals entering the food supply and FDA's feed ban."
JIM ROGERS: "All right, Dr. Clifford. Thank you very much. At this point we're going to open it up to questions. Operator?"
OPERATOR: "Yes. At this time we will take questions. To ask a question, please press *1. You will be asked to state your name and affiliation. Please limit your question to one only. Thank you.
"First question, Daniel Goldstein. Go ahead."
REPORTER: "Yeah. Hi, Dr. Clifford. Dan Goldstein, Bloomberg News. If this test-- there was no testing being done on the Western blot or the confirmatory sample--what are you going to do if the sample basically comes up also inconclusive in Weybridge? Will it be resampled again?
"And also, why was it not sent in by the veterinarian?"
DR. CLIFFORD: "It was a private practitioner, and as we indicated the private practitioner just forgot to submit that sample to us, and we just recently received that sample. As far as the testing of this, we're taking the first particular sample that we looked at on IHC was not definitive. We're looking at other portions of the brain stem. As we'd indicated before, you know you can have differing results in different parts of the brain stem.
"We are taking those samples, preparing them today, and we'll be sending those to Weybridge as well, so they'll be doing this in concert with us as well, running their IHC as well as us running ours.
"Just to add to that, after both of those laboratories are completed with their testing then we'll be reporting out the results to you."
JIM ROGERS: "Next question, please."
OPERATOR: "The next question is from Monica Conrad. Please state your affiliation."
REPORTER: "ABC News. Can you--I just kind of want to make sure I've got this clear. You said the vet added a preservative to this sample. Did the preservative then make it impossible to run a Western blot test on it, or are you planning a Western blot, or why not?"
DR. CLIFFORD: "The preservative is formalin, and formalin-fixed tissues cannot be used to run Western blots or, for that matter, other tests such as the screening tests that are used like the ELISA screening test. You cannot run those tests on the sample."
JIM ROGERS: "Next question, please?"
OPERATOR: "Next question from Scott Killman. Please state your affiliation."
REPORTER: "Wall Street Journal. Dr. Clifford, from your position is it most likely that this is just a sampling error, that--when you say 'non-definitive result' I'm not quite clear what you mean by that. Does that suggest there's a problem with the wrong part of the brain was collected, or --"
DR. CLIFFORD: "No, absolutely not. The correct part of the brain was sampled. One part of an IHC that makes that test a good test and a good confirmatory test and a test that's used worldwide for that purpose is being able to look at that under a microscope and being able to definitively say you're in the right portion of the brain. And that's the case here.
"We have a good sample from the standpoint we know the location of the brain. If you'll recall the last case, it was a very weak positive. It had focal points of prions in that brain. And in fact both the Western blot and the IHC had samples that were negative on that last case, as well as samples that were positive.
"So the same thing could be true here. That's why we're looking at different sections of the brain. And then we will be using also, Weybridge will use their IHC.
"As we'd indicated throughout this last case the IHC-- it's not a test that you can just buy off the shelf. And so there's little variations between laboratories, and so what one may not detect another one might. So we may have luck there.
"As far as this sample, as we said it was not definitive. Basically what that means is, is looking at that slide they would not be able to determine, or the slides determine that BSE, or be able to diagnose BSE in this case. And that's simply what it means."
JIM ROGERS: "Next question, please?"
OPERATOR: "Next question, Chris Clayton, please state your affiliation?"
REPORTER: "Omaha World-Herald. Dr. Clifford, I guess now it's been known in terms of the farm where this animal was, and can you give an idea of the size of the herd of the animal and the breed that was involved?"
DR. CLIFFORD: "I think at this point in time we would refrain from doing that until a point in time in which we--if we call this positive then we'd release that type of information. I am willing to tell you, we know exactly where this animal came from and we know that the animal was destroyed.
"Again, I'd like to reiterate, this animal was at least 12 years of age, born well prior to the feed ban."
OPERATOR: "The next question is from Philip Brasher. Please state your affiliation."
REPORTER: "Hi. Yes. The Des Moines Register. I just wanted to ask, could I 'tease out' this non-definitive test result. When you all determine something is non-definitive, does that mean see some of the effects of possibly BSE but it's not clear? What makes it non-definitive, or can you be specific about why you use that term?"
DR. CLIFFORD: "Basically the IHC test, besides looking at location of the brain stem you're also doing a staining technique to identify abnormal prion proteins. In this case they had some staining, but the staining did not match up with what they would typically see in a BSE case. It didn't have the normal distribution it would see within the samples. So basically that's why the request for doing additional testing, and that's why we're sending it to Weybridge as well."
JIM ROGERS: "Next question, please."
OPERATOR: "Next question from Beth Gorham. Please state your affiliation."
REPORTER: "Canadian Press Wire Service. Dr. Clifford, can you tell me if this was a homegrown cow or whether it was from Canada?"
DR. CLIFFORD: "From all indications that we have at this point in time, this is a domestic animal."
JIM ROGERS: "Next question, please?"
OPERATOR: "Next question from Randy Fabi. Please state your affiliation?"
REPORTER: "Reuters. Yes. Hi. I was wondering if you could tell me whether there's any quarantines being done and a traceback for the offspring and any herd-mates, and also whether this will have any impact on trade negotiations with Japan and South Korea."
DR. CLIFFORD: "We do not have a hold order on the location at this time. We have not called this a case of BSE. At the time we would do that, then it would be appropriate for us to put a hold order only in for a length of time for us to look at other animals of interest that may still be in that herd.
"As far as the negotiations with Japan and Korea, you know I think basically what I would say relative to Japan is, Japan's had 20 cases of BSE. I would hope this would not have any impact on our negotiations there. Both of these animals were born prior to the feed ban, so therefore I would hope it would not have any effect or impact upon negotiations with either of those countries."
JIM ROGERS: "Next question, please."
OPERATOR: "The next question is from Pete Salento. Please state your company name."
REPORTER: "FoodMarket.com. Dr. Clifford?"
DR. CLIFFORD: "Go ahead."
REPORTER: "Okay. You said the animal was a 12-year-old animal and it was flagged during calving complications in April. My question is, why was it not flagged for the biorad rapid screening test before it was preserved as part of the high-risk program?"
DR. CLIFFORD: "In remote locations and in some cases where veterinarians were out on the farm, at that point in time we allowed for those samples to be submitted in some cases in a formalin tissue to make sure that the sample got to us in a state that would allow for testing for immunohistochemistry. So therefore that's why we did that.
"Recently based upon this most recent case we changed our protocol to require those samples to be sent to us fresh, and the only time they could send them in fresh is if we were not able to receive those samples within 48 hours.
"Basically if you know the heat that we're having in Washington, DC and across much of the country, those samples can degrade pretty rapidly. So therefore we require that receipt of those to be shipped on ice within 48 hours. If it's beyond 48 hours and only then, and if and only then, can they ship it frozen if they can't get it to us in a timely fashion.
"I'd just like to reiterate that while that last sample was frozen and the Secretary made it specific not to ship frozen samples--and our points of collection where we have personnel there, none of those samples are to be shipped frozen under the same conditions. Basically they have to be shipped within 48 hours. And it's only under a rare circumstance would we allow frozen samples to be shipped.
"Now I want to also point out that frozen samples can be run against the Western blot, against the biorad test, and including the IHC."
JIM ROGERS: "Next question, please?
OPERATOR: "The next question is from Sandy Dutton. Please state your affiliation."
REPORTER: "My question was answered. Thank you."
OPERATOR: "Next question is from Bill Tomson. Please state your affiliation."
REPORTER: "Dow Jones. Hello, Dr. Clifford. I just want to--and maybe I'm beating a dead horse here--but there was some staining under the IHC, and that staining, as I understand, would suggest the possible infection of BSE. But because the staining is not what you'd normally see, it can't be confirmed this is a case of BSE? Am I understanding it right?"
DR. CLIFFORD: "Yes. You are."
REPORTER: "Okay."
DR. CLIFFORD: "There was some staining present. But it did not match a normal pattern, and we're taking through that to do additional tests in additional parts of the brain stem to try to see if we can find a normal staining pattern as well as sending that sample to Weybridge to run against their IHC."
JIM ROGERS: "Operator, at this time we have time for two more questions, please."
OPERATOR: "All right. The next question is from Jeremy Russell. Please state your affiliation."
REPORTER: "National Meat Association. Dr. Clifford, I was just wondering with the sample like this that's been around since April, what are you doing to verify chain of custody on that sample?"
DR. CLIFFORD: "Well, at this point in time we've received the sample at our National Veterinary Services Lab on July 19th. You know, we have talked to the veterinarian with regards to the location where he collected the sample, he or she actually collected the sample. And you know we have no reason to question that."
JIM ROGERS: "Next question, please?"
OPERATOR: "The last question comes from Beth Gorham. Your affiliation, please?"
REPORTER: "Canadian Press. One other question, Dr. Clifford. Does this have any implications for trade with Canada in cattle? And secondly, I wanted to ask you a little bit off-topic about the fact that Montana is encouraging all other states to impose their own increased tests on Canadian cattle--whether that was necessary?"
DR. CLIFFORD: "I didn't catch the last question, but as far as the trade issue with Canada this should not have any effect on trade with Canada. We as well as Canada have very similar safeguards and surveillance approaches to this disease. We've had longstanding relationships, and we would not anticipate any trade issues with Canada.
"Could you repeat that question about the states?"
OPERATOR: "If you'd press *1 again? Beth, your line is open again."
REPORTER: "Hello? Okay. Montana officials said today that they were going to encourage--later this week they were sending out a letter to all the other states to encourage them to do their own testing, for a fee, of Canadian cows that cross the border. And I know the Department has already said the Montana plan wasn't necessary. So I was wondering what USDA can do about this."
DR. CLIFFORD: "Specifically to our knowledge there's no state that's requiring any additional testing. I think what Montana had indicated is verification of what written mitigations we had. And we have no knowledge of other states applying additional mitigations within their state."
JIM ROGERS: "All right, Operator. That concludes the call for today. I'd like to thank everyone who listened in. And in case you missed it, today's call was done by USDA Chief Veterinarian Dr. John Clifford. Dr. Clifford is the Deputy Administrator for Veterinary Services with the Animal and Plant Health Inspection Service and part of the United States Department of Agriculture.
"The statement should be posted on the website shortly at WWW.APHIS.USDA.GOV
"Have a nice day, everybody."
Last Modified: 07/28/2005
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml
Release No. 0235.05
Contact:
Jim Rogers (202) 670-4755
TRANSCRIPT OF TELE-NEWS CONFERENCE WITH DR. JOHN CLIFFORD, CHIEF VETERINARY OFFICER, ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DR. STEPHEN SUNDLOF, DIRECTOR, CENTER FOR VETERINARY MEDICINE, FOOD AND DRUG ADMINISTRATION AND DR. BOB HILLMAN, EXECUTIVE DIRECTOR, TEXAS ANIMAL HEALTH COMMISSION IN WASHINGTON, DC ON JUNE 29, 2005
OPERATOR: Good afternoon, and good evening, and thank you all for holding. I'd like to remind all parties that your lines have been placed on a listen-only mode until the question-and-answer session. If anyone needs assistance, press "*" "0." And I would now like to turn the call over to Mr. Jim Rogers. Thank you, sir, you may begin.
MR. ROGERS: Hi, everyone. Thank you for calling, and thanks for your patience. We're starting a little late here tonight. This is Jim Rogers with the Animal and Plant Health Inspection Service, an agency of the U.S. Department of Agriculture.
We have for you tonight Dr. John Clifford -- he's our chief veterinarian here at APHIS -- and he's going to provide you with some updated information on our epidemiological investigation into the second case of BSE in the United States. We also have on the line Dr. Bob Hillman -- he's the executive director of the Texas Animal Health Commission; and Dr. Steve Sundlof -- he is the director of the Food and Drug Administration's Center for Veterinary Sciences.
So I'm going to turn the call over to Dr. Clifford. You're going to hear some statements made, and then we're going to go to Q and As, at which time we would ask that you identify yourself and your affiliation when you ask your question.
Dr. Clifford?
DR. CLIFFORD: " Thanks, Jim. And thanks everyone for joining us this evening.
"I'd like to begin with a statement and, as Jim had indicated, then we'll have maybe an additional statement and Q and As.
"DNA test results have confirmed that we have identified the source herd of the animal determined last week to be positive for BSE. Based on information we have received from the owner, the cow was born and raised in a herd in Texas and was approximately 12 years old. It was sent to a 3D/4D pet food plant in Texas and was selected for sampling on arrival.
"The source herd is now under a hold order as we identify animals of interest within the herd. Animals of interest would include any other animals that were born the same year as this animal, as well as any born the same year as this animal, as well as any born the year before and the year after. If the age of the animal cannot be pinpointed, then we may expand our inquiry to include all animals in this herd before the feed ban went into place in 1997. We are also interested in any of this animal's offspring that were born within the last 2 years.
"Experience worldwide has shown us that it is highly unusual to find BSE in more than one animal in a herd or in an affected animal's offspring. Nevertheless, all animals of interest will be tested for BSE.
"We are also working with the Food and Drug Administration in an effort to determine the feed history in this herd. Given the animal's age, we believe it was most likely infected by consuming feed prior to the implementation of the ruminant-to-ruminant feed ban in 1997.
"I emphasize that this animal did not enter the human food chain. The plant at which this animal was sampled is a 3D/4D pet food plant that does not handle animals for human consumption and, in this case, did not use the animal in the production of pet food. The remains were incinerated.
"The testing and traceback efforts may yield further information as to how this animal became infected. The safety of our food supply is not in question. I am very confident that our interlocking safeguards are effective, and this case is evidence of that. USDA bans nonambulatory cattle from the food supply. USDA bans animal parts that could carry BSE from the food supply. USDA bans slaughter techniques that could introduce BSE into the food supply. These safeguards ensure that American beef is among the safest in the world."
MR. ROGERS: "All right. At this time I was going to ask Dr. Bob Hillman if he had any statement he'd like to make."
DR. HILLMAN: " Thank you, Jim, just a very brief statement. While it does not give us pleasure to have a BSE-positive cow identified in the United States, and even more so in the state of Texas, we are dedicated to working with our animal health partners from USDA, and also with the food safety folks from FDA, in completing our response to this event, and we will work to get it completed as quickly as possible."
MR. ROGERS: " Thank you, Dr. Hillman. We do appreciate your cooperation.
A this point, operator, I'd like to open the floor to questions. And if everybody would please state their name and their affiliation, we can begin."
OPERATOR: Thank you. At this time, if anyone has a question, press "*" "1" on your touchtone phone. If you'd like to withdraw your question, press "*" "2." Once again, if anyone has a question, please press "*" "1" at this time.
Thank you. Our first question is from Andy Dworkin, and please state your affiliation.
QUESTION: Yes, hi. I'm with the Oregonian in Portland, Oregon. I was wondering a little bit more about what was done to trace. You mentioned some DNA testing. What exactly were you looking for with DNA, or what did that show?
And also, I know back in November, when you first announced the earliest tests on this animal, you mentioned that APHIS had already started the tracebacks. So I'm wondering why it seems to have taken a long time it seems in this case to confirm the herd?
DR. CLIFFORD: "Thanks, Andy. Basically the way this animal was traced -- actually, from initially we felt that we had the correct herd; we wanted to identify that appropriately with DNA. We did DNA analysis on the sample itself, and we went back to the herd and pulled blood samples on the animals from the herd to see if there was a direct relationship with animals in the herd to this animal. And, in fact, with the DNA testing that we have done thus far, we have identified two animals that are definitely related to the animal that was incinerated and determined to be BSE -- or to have BSE. Those animals would have been either an offspring or a dam to this animal.
"And as far as the information with regards to the trace, initially in November, when we reported this as an inconclusive, we began the 'epi' [epidemiological] and the tracing of this animal and herd. Once that sample was identified as being negative on our IHC tests, we stopped that trace. We recently began that trace again based upon the positive results from Weybridge and actually -- and then my determination -- had determined pretty quickly -- and verified that herd."
MR. ROGERS: Next question, please?
OPERATOR: Peter Shinn you may ask your question. And please state your affiliation.
QUESTION: Yes, thank you, and good evening. This is Peter Shinn with the National Association of Farm Broadcasters. Until all of the animals in question, herd mates, are identified, will the herd in question be quarantined? That's the first question. And then, secondly, why wait to say that this animal was from Texas until this period of time when that information was almost virtually publicly available.
DR. CLIFFORD: I didn't hear the last part of the question.
QUESTION: "Well, we'll start with the first one again, if I don't -- the first one is more important to me, which is the issue of quarantine. Will the herd in question be quarantined until all traceback efforts have been completed?"
DR. CLIFFORD: " The state of Texas, yes, has applied a hold order on this herd. As far as the second part of the question, I didn't understand."
QUESTION: I'm just asking why did you wait to confirm that this animal in question was from Texas, when it's been published that it was from Texas for some time. It seems like you're trying to clear up confusion and minimize questions and market disruption. And it seems like disclosing all information that you have, like for example that this animal was slaughtered at a facility in Texas might be useful in calling some of that market disruption.
DR. CLIFFORD: " Basically, if you go back to the original announcement we made last Friday, we indicated we need to verify this herd -- and we've done that through DNA analysis. We did not want to release information on the whereabouts of the herd until we had verified it."
MR. ROGERS: Next question, please.
DR. HILLMAN: "Dr. Clifford, if I may add one comment to that. It's also important to note that our cooperative lab in Texas tests animals from more than one state. So it is important to verify, as Dr. Clifford has indicated."
OPERATOR: Thank you. Sally Schuff you may ask your question, and please state your affiliation.
QUESTION: Thank you. This is Sally Schuff from FeedsStuffs. My question is for Dr. Clifford. Dr. Clifford, in the Friday announcement you said that the molecular protein banding pattern on this animal was more similar to French cases than the U.K. My question is: Does that indicate that this case is more similar to the bovine amloid spongiform encephalopathy than diagnosed in some few cases in Europe?
DR. CLIFFORD: "I don't think we can basically make that determination at this point. I think what we need to say is that from standpoints and regulatory purposes, this is a case of BSE. The molecular weight pattern on this animal was reported out as being a higher molecular weight, which is very similar to a few cases they found in France, and I think that's really at this point all we can say."
MR. ROGERS: Next question, please.
OPERATOR: Steve Kay, your line is open. Please state your affiliation.
QUESTION: Steve Kay of Cattle Buyers Weekly. Dr. Clifford, can you pinpoint or give us more details about the farm or ranch the cow came from? Did the cow remain on the farm its entire life? And you talked about some of the cohorts. My files show me that at least 205 animals were euthanized in the Washington State case. Do you have any notion at this point as to how many animals will be euthanized in this case?
DR. CLIFFORD: "No, we actually do not. The animal was, according to the owner, was born on this farm and raised on this farm its entire life -- owned by this owner. And so we really can't determine how many animals at this point in time we would be looking at as animals of interest. We would need to complete our epidemiology on that. But we would keep you updated relative to that information."
MR. ROGERS: Next question, please.
OPERATOR: Scott Kilman your line is open. Please state your affiliation.
QUESTION: Wall Street Journal. I'll follow up on Steve Kay's question and ask another one. One is: Can you identify -- can you tell us what town in Texas this ranch is located, the birth herd, is located?
Number two: Has the owner explained to you folks what made the animal a downer, or whether it was injured somehow or if it looked like it was suffering from some kind of sickness?
DR. CLIFFORD: " Basically the information that we have thus far is that we know that the animal was in poor condition at that time. So the -- any other specific information as far as the condition we'll be wanting to verify with the owner. The animal was reported to us in our initial investigation by the plant as being a downer at that facility. The -- was there another question there, sir?"
OPERATOR: I've already moved to the next question, sir.
DR. CLIFFORD: "As far as the location of the herd, we're not releasing that information. With regards to our programs, we feel that that's protected information, and we don't typically release that -- for this case, or for any of our programs for that matter."
MR. ROGERS: Next question, please.
OPERATOR: Thank you. Steve Vetter your line is open. Please state your affiliation.
QUESTION: Yes, Steve Vetter, Western Livestock Journal. Is this a registered herd, purebred herd, commercial herd? And then, also, when you were talking about the mislabeling of the sample from a breed standpoint, is this a cross-bred kind of cow, or is this actually of a certain breed makeup -- one specific breed?
DR. CLIFFORD: "As far as whether this particular owner has purebred animals or just all cross-breds, I'm not sure at this point in time. That's something that we would have to determine through our investigation. I can tell you that this particular animal was identified by the owner as a brahma-cross."
MR. ROGERS: Next question, please.
OPERATOR: Thank you. Chris Clayton, you may ask your question. And please state your affiliation.
QUESTION: This is Chris Clayton, with the Omaha World Herald. I was curious -- I guess this might be for Mr. Sundlof -- if -- are you concentrating on looking at feed for this animal prior to 1997, or are you also looking at the possibility that this animal may have received some contaminated feed after that? Can you say whether this animal was mostly on a grassfed operation? I mean, did it graze most of its life, or can you give us a little more on the feeding background that you know on this animal?
DR. SUNDLOF: "Okay, this is Steve Sundlof with the Food and Drug Administration Center for Veterinary Medicine. We don't know the answer to that. We're just learning of the origin of the animal.
What we will be doing is we'll be working very closely with the USDA. They will be doing the epidemiology work, investigation, trying to trace back the animal and any herds that the animal may have come from or cohorts may have gone to. And in all those cases we will be doing a traceback of the feed to try and find out what the history of the feed was. We will be looking at the compliance records for all of the firms that may have processed meat and bonemeal from cohorts of this animal, to determine whether or not they have been in compliance with the feed regulation since it's been in effect in 1997. Obviously before that time there was no feed regulation, so there is no compliance records for those firms before that. But we will do our best to trace back the records as far back as we can possibly go for any animals that USDA identifies in their epidemiological study."
DR. CLIFFORD: "And if I may, I'd just like to add one little point to that as well. And if you look at this disease worldwide, we know -- and from the research and information -- that the animals definitely are most likely to get this disease by eating contaminated feed at a very young age."
MR. ROGERS: Next question please.
OPERATOR: Shakar Vidantim (ph), your line is open. Please state your affiliation.
QUESTION: The Washington Post. Could you please spell the name of the pet store in detail and also confirm whether it was also in Texas? And, secondly, could you tell us why this animal was not used for pet food?
DR. CLIFFORD: "Basically let me begin by stating this. You know, at USDA, at APHIS here, we're really reluctant to identify the location of this facility. And let me explain why before we go on with the final answer with that. This facility, and other facilities, across the entire U.S., are helping us with this enhanced BSE surveillance program. And in reality this particular location did exactly what they needed to do with this facility and the animals and in holding these animals in an appropriate manner and having all these animals incinerated based upon our knowledge and guidance in this situation. And really from a traceback standpoint, they're out of the loop here. They have no additional value from a standpoint of the traceability and follow-up with this herd. So we really don't feel that this type of information has any additional value to the follow-up and epidemiology of this case.
However, to be transparent with you, what we're willing to say is this was a pet food facility. The pet food facility was located in Waco, Texas. But we certainly hope by releasing this information it doesn't affect those who are doing a good job and assisting us with this program nationally, because we want them to continue to do that. So we appreciate very much -- we recognize their efforts in this."
OPERATOR: Thank you. Jim Massey, you may ask your question. And please state your affiliation.
QUESTION: Yes, Jim Massey, from the Country Today Newspaper in Wisconsin. Why is the location of the animal protected information if information on the Washington State herd wasn't in December of '03?
DR. CLIFFORD: "We didn't release the information on the owner in '03. I think that was determined by others."
MR. ROGERS: Next question, please.
OPERATOR: Ted Oberg, you may ask your question. And please state your affiliation.
QUESTION: Hi, gentlemen, I'm from KTRK-Television in Houston. I guess two questions. One, can you tell us when this DNA information was confirmed? And, second, maybe for Dr. Hillman, how concerned are you this will put sort of a "Scarlet Letter" on Texas beef?
DR. CLIFFORD: "First off, the actuals -- I got the final formal report at approximately 5:00 today -- it was somewhere in that neighborhood -- this evening on the final DNA analysis on those two animals. And we actually have more animals still being tested, but as far as the initial analysis goes, it enabled us on this particular group of blood samples -- it enabled us to identify this herd. And I know Dr. Hillman wants to respond to your second question, but just let me say that this should not put any taint on any Texas beef, or for that matter U.S. beef. Our products U.S.-wide are safe. This disease is one that needs to be put in proper perspective. It's one case out of 388,000-plus samples that are found to be negative for this disease. The prevalence we know based on that would be extremely low in this country. And this is a surveillance program to estimate prevalence to determine that our safeguards are working, and they are working. And those safeguards have to do with the specified risk material removal to protect human health, and the feed bans to protect animal health."
And with that, Bob, if you'd like to add anything?"
DR. HILLMAN: " John, I think you've answered it very well. I don't have anything to add. Thank you."
MR. ROGERS: Next question, please.
OPERATOR: Sandy Doughten (ph), your line is open. Please state your affiliation.
QUESTION: I'm from the Seattle Times. Can you tell us why this animal was selected for testing and why the carcass was incinerated?
DR. CLIFFORD: "This animal was presented at 3D/4D facility, and at that time actually there were five animals presented that fit the categories for us. This animal was listed by the facility as a downer. And the animal was incinerated because of the inconclusive results. And based on those inconclusive results, we not only incinerated this animal; we incinerated the entire group of all five animals."
MR. ROGERS: Next question, please.
OPERATOR: Joe Palca, your line is open. Please state your affiliation.
QUESTION: I'm from National Public Radio. You said that you were going to be looking at animals born within a year or two, or at least one year to begin with, of the animal in question. And I'm wondering if you have any idea how many animals you're talking about there.
And the other question is for someone who's not familiar with cattle practices all that much, is it uncommon to find a lot of 12-year-old animals in a herd of cattle?
DR. CLIFFORD: "As far as our plans, I can't give you an exact number until we actually get into the investigation itself, and we'll be glad to provide you all that type of information and details when we have it.
"As far as the age, you know, it's probably less common to find that old an animal in the dairy industry. But within the beef industry you can certainly find older, aged animals within the industry, as long as those animals are still productive."
OPERATOR: Jerry Hagstrom, you may ask your question. Please state your affiliation.
QUESTION: Yes, this is Jerry Hagstrom from Congress Daily. I'd also like to ask about the statement last Friday that the brain pattern was that of cows in France that had mad cow disease. I'm wondering if this would indicate that the type of feed that this cow would have had would probably have been different from the kind of feed that had been used in Canada? Or do you have any other explanation as to why this cow in Texas would have a different brain pattern than the one up in Washington State?
DR. CLIFFORD: " I think we really couldn't respond to that, and I wouldn't want to speculate whether it has any relationship with feed or the source of that feed. I think that that's something -- a question that would have to be answered, or attempted answered later on, after there would be more understanding with regards to the different types of BSE and the way it expresses itself. So that's something that's going to have to be answered with time and research."
MR. ROGERS: Operator, at this time we have just enough time for two more questions please.
OPERATOR: Karen Jacobs, your line is open. Please state your affiliation.
QUESTION: Karen Jacobs, Dallas Morning News. Can you give us any idea of the size of the herd? And also in terms of the breeding, how recently was this cow, animal, still breeding? Do we know?
DR. CLIFFORD: "Based on the size of the herd, I would probably need to get those results or actual numbers. You know, I really don't want to release that until I have good numbers to go with, and so we are waiting on that information. I think also we would be interested in the last two years of birth and I think we need to confirm some information there with the owner with regards to the most recent offspring. So that's additional information we'll be glad to release when we have that nailed down on the epi."
MR. ROGERS: Final question, please, operator.
OPERATOR: Yes, our final question comes from Don Wall. Your line is open. Please state your affiliation.
QUESTION: Yes, thank you. I'm Don Wall from WFAA-TV in Dallas, and I wanted to know if other animals from that herd in Texas have been or will be euthanized. And I wanted to know if, because of this information, if there will be any bans on exports of Texas cattle to either other states or nations?
DR. CLIFFORD: "As we go through the epidemiology and we find what we call animals of interest that we have identified -- that would be animals that were born in that herd in the same year that this particular animal was born, or within one year before to one year after, to the last two offspring this particular cow had -- within the last two years, I should say, specifically -- those animals, if found or located, those animals would be indicated as -- or identified as animals of interest and would be tested.
"As far as bans, I would certainly hope that no state in the United States would ban beef products from the state of Texas. It wouldn't make sense, scientifically with the safeguards in place. And I think as everybody well knows, USDA is working very hard to reopen markets, and as well as trying to maintain those that are still currently open."
MR. ROGERS: All right, thank you. I'd like to thank everyone for being on the call tonight. Before you all go, I'd just like to give you everyone's name and title again. From the USDA we have Dr. John Clifford -- that's C-L-I-F-F-O-R-D -- he's the chief veterinarian with the Animal and Plant Health Inspection Service. We have Dr. Steve Sundlof -- S-U-N-D-L-O-F. He is the director of FDA's Center for Veterinary Medicine, as opposed to "Sciences," as I said earlier. And we also have with us Dr. Bob Hillman -- H-I-L-L-M-A-N, executive director of the Texas Animal Health Commission. Thank you, gentlemen, for participating in the call. And I'd like to thank the reporters for attending. Please feel free to call us at APHIS if you have further questions in the future. Operator, this concludes the call.
OPERATOR: Thank you. You may disconnect at this time.
Last Modified: 06/30/2005
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/06/0235.xml
FDA Statement
FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.
FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.
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).
FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.
####
ooops!
http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
cattle on feed in Texas
FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
--------------------------------------------------------------------------------
Note: On Dec. 23, 2003, the U.S. Department of Agriculture reported that a cow in Washington state had tested positive for bovine spongiform encephalopathy (BSE, or mad cow disease). As a result, information on this Web page stating that no BSE cases had been found in the United States is now incorrect. However, because other information on this page continues to have value, the page will remain available for viewing.
FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
Today the Food and Drug Administration announced the results of tests taken on feed used at a Texas feedlot that was suspected of containing meat and bone meal from other domestic cattle -- a violation of FDA's 1997 prohibition on using ruminant material in feed for other ruminants. Results indicate that a very low level of prohibited material was found in the feed fed to cattle.
FDA has determined that each animal could have consumed, at most and in total, five-and-one-half grams - approximately a quarter ounce -- of prohibited material. These animals weigh approximately 600 pounds.
It is important to note that the prohibited material was domestic in origin (therefore not likely to contain infected material because there is no evidence of BSE in U.S. cattle), fed at a very low level, and fed only once. The potential risk of BSE to such cattle is therefore exceedingly low, even if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy Commissioner, "The challenge to regulators and industry is to keep this disease out of the United States. One important defense is to prohibit the use of any ruminant animal materials in feed for other ruminant animals. Combined with other steps, like U.S. Department of Agriculture's (USDA) ban on the importation of live ruminant animals from affected countries, these steps represent a series of protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., is nonetheless announcing that it is voluntarily purchasing all 1,222 of the animals held in Texas and mistakenly fed the animal feed containing the prohibited material. Therefore, meat from those animals will not enter the human food supply. FDA believes any cattle that did not consume feed containing the prohibited material are unaffected by this incident, and should be handled in the beef supply clearance process as usual.
FDA believes that Purina Mills has behaved responsibly by first reporting the human error that resulted in the misformulation of the animal feed supplement and then by working closely with State and Federal authorities.
This episode indicates that the multi-layered safeguard system put into place is essential for protecting the food supply and that continued vigilance needs to be taken, by all concerned, to ensure these rules are followed routinely.
FDA will continue working with USDA as well as State and local officials to ensure that companies and individuals comply with all laws and regulations designed to protect the U.S. food supply.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
Risk of oral infection with bovine spongiform encephalopathy agent in primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog, Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe Deslys
Summary The uncertain extent of human exposure to bovine spongiform encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease (vCJD)--is compounded by incomplete knowledge about the efficiency of oral infection and the magnitude of any bovine-to-human biological barrier to transmission. We therefore investigated oral transmission of BSE to non-human primates. We gave two macaques a 5 g oral dose of brain homogenate from a BSE-infected cow. One macaque developed vCJD-like neurological disease 60 months after exposure, whereas the other remained free of disease at 76 months. On the basis of these findings and data from other studies, we made a preliminary estimate of the food exposure risk for man, which provides additional assurance that existing public health measures can prevent transmission of BSE to man.
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley's surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
6. It also appears to me that Mr Bradley's answer (that it would take less than say 100
grams) was probably given with the benefit of hindsight; particularly if one
considers that later in the same answer Mr Bradley expresses his surprise that it
could take as little of 1 gram of brain to cause BSE by the oral route within the
same species. This information did not become available until the "attack rate"
experiment had been completed in 1995/96. This was a titration experiment
designed to ascertain the infective dose. A range of dosages was used to ensure
that the actual result was within both a lower and an upper limit within the study
and the designing scientists would not have expected all the dose levels to trigger
infection. The dose ranges chosen by the most informed scientists at that time
ranged from 1 gram to three times one hundred grams. It is clear that the designing
scientists must have also shared Mr Bradley's surprise at the results because all the
dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts
[BBC radio 4 FARM news]
http://www.maddeer.org/audio/BBC4farmingtoday2_1_03.ram
http://www.fda.gov/ohrms/dockets/ac/03/slides/3923s1_OPH.htm
2) Infectious dose:
To cattle: 1 gram of infected brain material (by oral ingestion)
http://www.inspection.gc.ca/english/sci/bio/bseesbe.shtml
NEW MAD COW STRAIN CALLED BASE, VERY SIMILAR TO SPORADIC CJD IN HUMANS;
Medical Sciences
Identification of a second bovine amyloidotic spongiform encephalopathy: Molecular similarities with sporadic Creutzfeldt-Jakob disease
Cristina Casalone *, Gianluigi Zanusso , Pierluigi Acutis *, Sergio Ferrari , Lorenzo Capucci , Fabrizio Tagliavini ¶, Salvatore Monaco ||, and Maria Caramelli *
*Centro di Referenza Nazionale per le Encefalopatie Animali, Istituto Zooprofilattico Sperimentale del Piemonte, Liguria e Valle d'Aosta, Via Bologna, 148, 10195 Turin, Italy; Department of Neurological and Visual Science, Section of Clinical Neurology, Policlinico G.B. Rossi, Piazzale L.A. Scuro, 10, 37134 Verona, Italy; Istituto Zooprofilattico Sperimentale della Lombardia ed Emilia Romagna, Via Bianchi, 9, 25124 Brescia, Italy; and ¶Istituto Nazionale Neurologico "Carlo Besta," Via Celoria 11, 20133 Milan, Italy
Edited by Stanley B. Prusiner, University of California, San Francisco, CA, and approved December 23, 2003 (received for review September 9, 2003)
Transmissible spongiform encephalopathies (TSEs), or prion diseases, are mammalian neurodegenerative disorders characterized by a posttranslational conversion and brain accumulation of an insoluble, protease-resistant isoform (PrPSc) of the host-encoded cellular prion protein (PrPC). Human and animal TSE agents exist as different phenotypes that can be biochemically differentiated on the basis of the molecular mass of the protease-resistant PrPSc fragments and the degree of glycosylation. Epidemiological, molecular, and transmission studies strongly suggest that the single strain of agent responsible for bovine spongiform encephalopathy (BSE) has infected humans, causing variant Creutzfeldt-Jakob disease. The unprecedented biological properties of the BSE agent, which circumvents the so-called "species barrier" between cattle and humans and adapts to different mammalian species, has raised considerable concern for human health. To date, it is unknown whether more than one strain might be responsible for cattle TSE or whether the BSE agent undergoes phenotypic variation after natural transmission. Here we provide evidence of a second cattle TSE. The disorder was pathologically characterized by the presence of PrP-immunopositive amyloid plaques, as opposed to the lack of amyloid deposition in typical BSE cases, and by a different pattern of regional distribution and topology of brain PrPSc accumulation. In addition, Western blot analysis showed a PrPSc type with predominance of the low molecular mass glycoform and a protease-resistant fragment of lower molecular mass than BSE-PrPSc. Strikingly, the molecular signature of this previously undescribed bovine PrPSc was similar to that encountered in a distinct subtype of sporadic Creutzfeldt-Jakob disease.
--------------------------------------------------------------------------------
C.C. and G.Z. contributed equally to this work.
||To whom correspondence should be addressed.
E-mail:
[email protected]. .
www.pnas.org/cgi/doi/10.1073/pnas.0305777101
http://www.pnas.org/cgi/content/abstract/0305777101v1
1: J Infect Dis 1980 Aug;142(2):205-8
Oral transmission of kuru, Creutzfeldt-Jakob disease, and scrapie to nonhuman primates.
Gibbs CJ Jr, Amyx HL, Bacote A, Masters CL, Gajdusek DC.
Kuru and Creutzfeldt-Jakob disease of humans and scrapie disease of sheep and goats were transmitted to squirrel monkeys (Saimiri sciureus) that were exposed to the infectious agents only by their nonforced consumption of known infectious tissues. The asymptomatic incubation period in the one monkey exposed to the virus of kuru was 36 months; that in the two monkeys exposed to the virus of Creutzfeldt-Jakob disease was 23 and 27 months, respectively; and that in the two monkeys exposed to the virus of scrapie was 25 and 32 months, respectively. Careful physical examination of the buccal cavities of all of the monkeys failed to reveal signs or oral lesions. One additional monkey similarly exposed to kuru has remained asymptomatic during the 39 months that it has been under observation.
PMID: 6997404
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=6997404&dopt=Abstract
TSS
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