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From: TSS ()
Subject: Re: Investigation Results of Texas Cow That Tested Positive for Bovine Spongiform Encephalopathy (BSE) Aug. 30, 2005
Date: August 30, 2005 at 10:52 am PST

In Reply to: Re: Investigation Results of Texas Cow That Tested Positive for Bovine Spongiform Encephalopathy (BSE) Aug. 30, 2005 posted by TSS on August 30, 2005 at 10:49 am:

Name: TSS 2005
Subject: FSIS Notices 54-05, Policy on Use of Results from Third Party
Laboratories (Fong Effect)
Body of Message:



NOTE: This notice reissues the contents of FSIS Notice 52-03 in its

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


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

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/


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


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


Was there assurance that the results obtained by the third

Release No. 0280.05
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

"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

"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

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

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

JIM ROGERS: "Next question, please."

OPERATOR: "The next question is from Pete Salento. Please state your company

REPORTER: " 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

"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

REPORTER: "My question was answered. Thank you."

OPERATOR: "Next question is from Bill Tomson. Please state your

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."


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,

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,

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

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

"The statement should be posted on the website shortly at WWW.APHIS.USDA.GOV

"Have a nice day, everybody."

Last Modified: 07/28/2005

Release No. 0235.05
Jim Rogers (202) 670-4755


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

"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

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

Thank you. Our first question is from Andy Dworkin, and please state your

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

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

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

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

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

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

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

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

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

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

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

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

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

FDA 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

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.



cattle on feed in Texas

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.


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

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.

Risk of oral infection with bovine spongiform encephalopathy agent in

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
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

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.


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

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

that the actual result was within both a lower and an upper limit within the

and the designing scientists would not have expected all the dose levels to

infection. The dose ranges chosen by the most informed scientists at that

ranged from 1 gram to three times one hundred grams. It is clear that the

scientists must have also shared Mr Bradley's surprise at the results
because all the

dose levels right down to 1 gram triggered infection.

Re: BSE .1 GRAM LETHAL NEW STUDY SAYS via W.H.O. Dr Maura Ricketts

[BBC radio 4 FARM news]

2) Infectious dose:

To cattle: 1 gram of infected brain material (by oral ingestion)


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,

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: .

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


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