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From: TSS ()
Subject: Identification and Characterization of the First U.S. Bovine Spongiform Encephalopathy Case
Date: July 31, 2005 at 9:00 am PST


Research

Title: Identification and Characterization of the First U.S. Bovine Spongiform Encephalopathy Case

Authors

Richt, Juergen
Kluge, John - NVSL, APHIS, AMES, IA
Alt, David
Kunkle, Robert - bob
Hamir, Amirali
Czub, Stefanie - NATL BSE REF LAB, CANADA
Davis, Arthur - NVSL, APHIS, AMES, IA
Hall, S Mark - NVSL, APHIS, AMES, IA


Submitted to: Meeting Abstract
Publication Acceptance Date: January 2, 2004
Publication Date: January 4, 2004
Citation: Richt, J.A., Kluge, J.P., Alt, D.P., Kunkle, R.A., Hamir, A.N., Czub, S., Davis, A.J., Hall, S. 2004. Identification And Characterization Of The First U.S. Bovine Spongiform Encephalopathy Case. Poster Created For Use By The USDA At A Meeting With The Office Of International Epizootics.

Technical Abstract: Bovine spongiform encephalopathy (BSE) is a transmissible spongiform encephalopathy of cattle, first detected in 1986 in the U.K. and subsequently in other countries. BSE may have arisen either from the infectious agent scrapie, which causes a similar disease in sheep and goats, or from a germline mutation in the protein-coding region of the prion protein (PrP) gene of affected cattle. Here, we report on the prion protein polypeptide profile and genotype from the first identified case of BSE in the State of Washington in the United States. The six-year old Holstein cow was nonambulatory at slaughter and the formalin-fixed obex area of the brainstem was found to contain spongiform changes and vacuolated neurons by histopathology and the abnormal form of the prion protein, PrPBSE, by immunohistochemistry. Species determination was made on the formalin-fixed tissue. Extensive PrPBSE deposition in the obex was confirmed by Western blot analyses and enzyme-linked immunosorbent assay using brainstem and cerebellum derived from fresh tissue from the suspect animal. The PrPBSE polypeptide profile from the U.S. BSE case was characterized by (i) a lower molecular mass of the unglycosylated PrPBSE polypeptide fragment compared to samples from sheep with scrapie and deer with chronic wasting disease, (ii) good immunoreactivity with monoclonal antibody 6H4 directed against the central region of the PrP, but a lack of staining with monoclonal antibody P4, which recognizes the protease-resistant N-terminal end of the PrP; and (iii) a glycoform profile with a high proportion of the diglycosylated PrPBSE isoform. Comparison of the U.S. BSE isolate to the recent Canadian and European BSE isolates revealed similar sized PrPBSE polypeptide fragments using anti-PrP antibody 6H4. The PrP gene from the U.S. BSE case was amplified from both, fresh and formalin-fixed brain material and found to be of bovine origin with a normal, rather unremarkable cattle PrP sequence. This cow had a synonymous polymorphism at codon 192, and both alleles contained the six-copy octapeptide repeat region. We conclude from these studies that (i) the PrPBSE profile from the first U.S. BSE case showed similar molecular properties to the typical PrPBSE pattern described for the Canadian and European BSE isolates, and (ii) a germline mutation in the bovine PrP gene is not likely the etiological cause in this case. This information is consistent with the hypothesis that the U.S. BSE case - similar to the one in Canada - was most likely exposed to contaminated feed.


http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=160998

>>>Comparison of the U.S. BSE isolate to the recent Canadian and European BSE isolates revealed similar sized PrPBSE polypeptide fragments using anti-PrP antibody 6H4.<<<


Greetings,


IT would be interesting to know, if the anti-PrP antibody 6H4
was used on the Texas mad cow (#2), and on the 3rd cow, where ever that cow might be from. is this standard antibody for all BSE/TSE test on cattle in USA? if we have a unique situation as i predected of more virolent strains of TSE in the USA due to the many different strains in the many different species, and then rendered and fed back to animals for human and animal consumption for decades (amplification), would the 'anti-PrP antibody 6H4' pick up a postive reading? i find it very disturbing not knowing where these cows are coming from and that the media is playing down the issue and not demanding answers via whatever route and means necessary.

ALSO i am curious again about suspect rabies cases that test negative. HOW many of those rabies suspect ''negative'' cases
in USA bovine, how many are then tested for a TSE???

Subject: U.S. Emergency Bovine Spongiform Encephalopathy Response Plan
Summary
Date: Tue, 4 May 1999 18:25:12 -0500
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

snip...

NVSL also examines
samples from neurologically ill cattle and nonambulatory ("DOWNER")
cattle identified on the farm or at slaughter and from rabies-negative
cattle submitted to veterinary diagnostic laboratories and teaching
hospitals.

snip...

WHERE are those records for the last 10 to 15 years?...TSS

snip...

If additional tests do suggest a presumptive diagnosis of BSE, an NVSL
pathologist will hand carry the sample to the United Kingdom for
confirmation. It is at this critical point, when NVSL suggests a
diagnosis of BSE and is preparing to send the sample to the United
Kingdom, that this BSE Response Plan is initiated. The Plan begins the
preliminary notification from NVSL to APHIS.

snip...

NOT anymore, Johanns et al have now got the FONG SYNDROME...TSS

snip...

Prelimanary Notification

The director of NVSL is responsible for immediately notifying the APHIS,
Veterinary Services (VS) deputy administrator when tests suggest a
presumptive diagnosis of BSE.
Once NVSL has made a presumptive diagnosis of BSE, APHIS and FSIS field
activities will also be initiated. APHIS will receive notification
(either confirming or not confirming NVSL's diagnosis) from the United
Kingdom anywhere between 24 and 96 hours. (The international animal
health community has recognized the United Kingdom's Central Veterinary
Laboratory {CVL} as the world's reference laboratory for diagnosing BSE.
Other countries, including Belgium, France, Ireland, Luxembourg, the
Netherlands, Portugal, and Switzerland, have all sent samples to this
lab to confirm their first case of BSE).

snip...

WELL, except in TEXAS, home where we send some suspect mad cows straight to the render without any testing at all, home where other cows that test postive, time and time again, where these same postive cows takes 7+ months to get to the public domain, home also where we feed our TEXAS MAD COWS 5.5 grams of suspect ruminant feed, and the FDA says it's O.K....TSS

snip...END

BSE Red Book 2.1-26 1998

5.0 Response to Disease Outbreak

snip...

A quarantine zone or buffer zone is not necessary in case of a BSE
outbreak, but the area must be geographically identified if the BSE
cases were domestic cases; similar feeding practices in the area may be
a risk factor.

snip...

BSE Red Book 2.1-39

7.6 Depopulation Procedures

7.6.1 Factors and Considerations
If the owner is agreeable, a humane method of euthanasia of BSE suspects
will be necessary to facilitate the accurate diagnosis of the disease
problem, to ensure that the suspect animal is not slaughtered or
rendered, and to terminate the animal's suffering. Under no
circumstances may BSE suspects be sent fo slaughhter or rendering.

snip...

October 1998

BSE Red Book 2.1-40

7.7 Disposal
Under no circumstances may BSE suspects be sent to slaughter or
rendering.

snip...

FAST FORWARD TEXAS 2004

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.

####

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

BACK TO 1998 BSE RED BOOK

7.10.113 Producer Defense---The most effective way to prevent an
intruduction of BSE into a herd is not to feed ruminant byproducts to
ruminants. As of August 4, 1997, the FDA has a ban in place which
prohibits the feeding of most mammlian proteins to ruminants...

snip...

FAST FORWARD JUNE 2005

From: TSS ()
Subject: MAD COW FEED BAN WARNING LETTER USA June 9, 2005
Date: July 5, 2005 at 8:46 am PST

Department of Health and Human Services Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7119
FAX: (612) 334-4142


June 9, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-15

Michael J. Langenhorst
President
Anamax Corporation
P.O. Box 10067
Green Bay, WI 54307

Dear Mr. Langenhorst:

Our inspection of your rendering plant located at 505 Hardman Avenue South, South St. Paul, Minnesota, from January 12-20, 2005, revealed significant deviations from the requirements set forth in Title 21, Code of Federal Regulations , Part 589 .2000 (21 CFR 589 .2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE). Because you failed to follow the requirements of this regulation, products being manufactured and distributed by your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(a)(4)], and misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)].

Our investigation found that you failed to provide for measures to prevent commingling or cross-contamination and to maintain sufficient written procedures [21 CFR 589.2000(e)] in that:

1. You failed to use clean-out procedures or other means adequate to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

2. You failed to maintain written procedures specifying the clean-out procedures or other means to prevent carryover of protein derived from mammalian tissues into feeds that may be used for ruminants.

Our investigation also found that you failed to label products that may contain protein derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants." For example, your Feather Meal and Stabilized Poultry By-Product Meal lack this statement, even though the absence of sufficient measures to avoid commingling or cross-contamination may result in these products containing protein derived from mammalian tissues. Because your products do not bear this caution statement, they are misbranded under Section 403(a)(1) of the Act [21 U.S .C. 343(a)(1)).

The above is not intended as an all-inclusive list of violations. As a manufacturer of materials intended for animal feed use, you are responsible for ensuring that your overall operation and the products you manufacture and distribute are in compliance with the law.

You should acknowledge this letter within 15 working days of receiving and include any additional corrective actions concerning your facility. We have received your letter dated January 31, 2005, which replies to the Form FDA-483 issued on January 20, 2005, and your letter dated February 25, 2005, that states all corrections have been implemented. The corrections you have reported appear to be adequate but will be evaluated further during our follow-up inspection.

Your response should be directed to Compliance Officer Jane E . Nelson at the address on the letterhead. If you have any questions regarding this letter, you may phone Ms. Nelson at (612) 758-7119.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


http://www.fda.gov/foi/warning_letters/g5373d.pdf

snip...back to BSE RED BOOK 1998

7.11 Records Maintenance in a Foreign Animal Disease Outbreak

The APHIS FEDS will be used by the READEO to record information. FEDS a
computerized network designed to transmit accurate information rapidly
during any emergency disease outbreak. The use of FEDS will allow the
READEO to direct its attention to the minute-to-minute business of
containing and eradicating the disease.
For an accurate record of the activities, all field supervisors in a
READEO task force should maintain a diary. Activities and observations
should be recorded in the diary when they occur. Date all documents and
enter events by time and date to show a correct chronology.
Enter events as they occur in the diary as well. An accurate history is
of considerable value in developing policies and plans for future
disease-eradication

October 1998

BSE Red book 2.1-45

programs, and it may be important if there is litigation. A diary will
be helpful for day-to-day administration of funds, personnel, and
equipment. It is also useful as a later reference in preparing reports
and summaries of activities. ...

snip...

FAST FORWARD JULY 2005

FONG SYNDROME STRIKES USA

Testing options are limited in this case. Because the farm was remote, the private veterinarian who removed the brain sample used a substance to preserve the tissue. That means that only one type of testing, immunohistochemistry, or IHC, can be done.

The animal died in April, but the veterinarian forgot to send the sample to USDA until this month, Mr. Clifford said. "While that time lag is not optimal, it has no implications in terms of the risk to human health," he said.

snip...

BSE RED BOOK 1998

7.11.1 Daily Reporls
Submit daily reports of significant activities to the READEO Director
and the VS, Emergency Programs staff Riverdale, MD. (Refer to appendix F
for current telephone listings.)
Include the following as part of the historical file of an outbreak:

*Maps showing premises where BSE-infected animals were found;
*Inventory of feeds and feed sources;
*Origin of BSE-suspeet and confirmed animals;
*Public information material distributed, newspaper clippings; and,
Administrative reports to support the expenditure of funds, utilization
of personnel and equipment, and disposition of excess materials and
equip­ment at the end of the program.

snip...

FAST FORWARD 2005 ON THE TEXAS MAD COWS COVER-UP ;

>>>DEFRA's Matthew said that USDA's different results from its BSE tests may
have more to do with the quality of the samples being studied than the
effectiveness of the tests.<<<


>>>That situation, he said, isn't uncommon. "There can be variations in the
amount of abnormal prions in the brain stem and you could take one sample
that's got enough in it and another sample that hasn't got enough.... If you
can't confirm your initial result by applying a second test then it's good
practice to try a third." <<<


SO, seems this would mean that the June 2004 Enhanced BSE cover-up and the
testing of those 388,309 head of cattle to date, were terribly flawed,
therefore were meaningless and should ALL be retested with proper TSE
protocol. IF USDA changes testing protocol again, would this not mean these
test were flawed and meaningless?


ANOTHER reason is by only looking at one portion of the brain, you miss the
rest of the brain that could be potentally infected. kinda like a 1 in 10
chance of finding something. but this is par for the course with these
folks....TSS


USDA 2003

We have to be careful that we don't get so set in the way we do things that
we forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.
Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip.............


Dr. Detwiler: It seems a good idea, but I'm not aware of it.
Another important thing to get across to the public is that the negatives
do not guarantee absence of infectivity. The animal could be early in the
disease and the incubation period. Even sample collection is so important.
If you're not collecting the right area of the brain in sheep, or if
collecting lymphoreticular tissue, and you don't get a good biopsy, you
could miss the area with the PRP in it and come up with a negative test.
There's a new, unusual form of Scrapie that's been detected in Norway. We
have to be careful that we don't get so set in the way we do things that we
forget to look for different emerging variations of disease. We've gotten
away from collecting the whole brain in our systems. We're using the brain
stem and we're looking in only one area. In Norway, they were doing a
project and looking at cases of Scrapie, and they found this where they did
not find lesions or PRP in the area of the obex. They found it in the
cerebellum and the cerebrum. It's a good lesson for us. Ames had to go
back and change the procedure for looking at Scrapie samples. In the USDA,
we had routinely looked at all the sections of the brain, and then we got
away from it. They've recently gone back.

Dr. Keller: Tissues are routinely tested, based on which tissue provides an
'official' test result as recognized by APHIS
.

Dr. Detwiler: That's on the slaughter. But on the clinical cases, aren't
they still asking for the brain? But even on the slaughter, they're looking
only at the brainstem. We may be missing certain things if we confine
ourselves to one area.


snip...


FULL TEXT;


Completely Edited Version
PRION ROUNDTABLE


Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado


snip...

BSE RED BOOK 1998

7.11.2 Distribution
The VS, Emergency Programs staff will distribute reports of significant
activities to all AVIC's, State cooperators, and industry cooperators at
least weekly. As soon as significant events occur, Emergency Programs
will inform all APHIS

will inform all APHIS headquarters units through normal reporting
channels. Emergency Programs also will immediately report any
significant events to the Deputy Administrator, VS, who will immediately
advise the APHIS Administrator, especially of legal or politically
important events. A weekly summary report of control and eradication
activities will be provided to the APHIS Administrator and the Deputy
Administrator, VS. See BSE Response Plan, communications section.

7.11.3 Disposition
Records should be maintained until a historical account of the program
has been prepared and all pertinent information has been gleaned from
the records.
Furthermore, all records should be maintained if there may be legal
action pending as a result of the program activities. Usually,
administrative records are maintained a minimum of 3 years for audit
purposes...END...TSS


Greetings again,

i think the media is not doing there job by not using any means necessary to find the location of the 2nd confirmed mad cow in TEXAS and the 3 suspect cow now. by the USDA refusing to give the exact location to the public, only further supports a cover-up in the USA of mad cow diseases of all strains...

TSS



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