Subject: OIE REPORT ON BOVINE SPONGIFORM ENCEPHALOPATHY IN THE UNITED STATES OF AMERICA
Date: March 18, 2006 at 11:50 am PST
BOVINE SPONGIFORM ENCEPHALOPATHY IN THE UNITED STATES OF AMERICA
See also: 1 July 2005
(Date of previous outbreak of bovine spongiform encephalopathy in the United States of America reported to the OIE: November 2004 and confirmed: June 2005).
Immediate notification report
Information received on 15 March 2006 from Dr Peter Fernandez, Associate Administrator, Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA), Washington, DC:
Report date: 13 March 2006.
Reason for immediate notification: re-occurrence of a listed disease or infection in a country following a report declaring the outbreak(s) ended.
Date of first confirmation of the event: 13 March 2006.
Date of start of the event: 27 February 2006.
Clinical disease: yes.
Nature of diagnosis: clinical and laboratory.
Details of outbreak:
First administrative division (State) Type of epide-miolo-gical unit Date of start of the outbreak Spe-cies Number of animals in the outbreak
susceptible cases deaths destroyed slaugh-tered
Alabama farm 27 Feb. 2006 bov 50 1 0 1 0
Description of affected population: a beef cow (aged at least 10 years) in a herd of approximately 50 beef cows and calves.
Diagnosis: the affected cow was examined and then culled because it was a non-ambulatory animal.
Laboratory where diagnostic tests were performed Species examined Diagnostic tests used Date Results
National Veterinary Services Laboratory, Ames, Iowa bov Western blot 11 March 2006 positive
immunohistochemistry pending
Source of outbreak or origin of infection: unknown or inconclusive.
Control measures undertaken: quarantine.
Other details/comments:
- This is the second confirmed case of indigenous bovine spongiform encephalopathy to be reported in the United States of America.
- The animal was culled, sampled, buried on the farm, and did not enter the animal and human food chains.
- Federal and Alabama State animal health officials are currently conducting an epidemiological investigation to gather further information on the herd of origin.
- Federal officials are also working to determine if there is any relevant feed history associated with this case.
Final report: no.
http://www.oie.int/eng/info/hebdo/A_CURRENT.HTM#Sec8
*
* *
BOVINE SPONGIFORM ENCEPHALOPATHY IN THE UNITED STATES OF AMERICA
See also: 16 March 2006
(Date of previous case of bovine spongiform encephalopathy in the United States of America reported to the OIE: December 2003 [in an imported animal]).
Immediate notification report
Information received on 27 June 2005 from Dr Peter Fernandez, Associate Administrator, Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA), Washington, DC:
Report date: 27 June 2005.
Reason for immediate notification: re-occurrence of a listed disease or infection in a country or zone/compartment following a report declaring the outbreak(s) ended.
Date of first confirmation of the event: 23 December 2004.
Date of start of the event: November 2004.
Nature of diagnosis: clinical and laboratory.
Description of affected population: the affected cow was born before the United States instituted a ruminant-to-ruminant feed ban, which was placed in August 1997. The USDA has initiated an investigation to determine the animal's herd of origin.
Diagnosis:
This particular animal was identified for testing because, as a non-ambulatory animal, it was considered to be at higher risk for bovine spongiform encephalopathy (BSE).
The initial rapid screening test on the animal in November 2004 yielded an inconclusive result - this triggered the USDA to conduct the internationally accepted confirmatory immunohistochemical (IHC) test. The IHC test was negative, and thus the animal was considered negative.
As a result of an internal review by the USDA's Office of Inspector General (OIG), the OIG recommended that additional tests (using Western blot techniques) be conducted on the three samples that had yielded inconclusive results, but had tested negative on the confirmatory IHC test.
Two of these samples were further confirmed negative, but one sample yielded a positive result using the Western blot technique. This sample was also sent to the OIE Reference Laboratory for BSE in Weybridge, United Kingdom, where the Western blot test and an additional IHC test also yielded a positive result.
Laboratories where diagnosis was made Diagnostic tests used Date Results
National Veterinary Services Laboratory, Ames, Iowa rapid screening test November 2004 inconclusive
immunohistochemistry November 2004 negative
Western blot June 2005 positive
VLA Weybridge, United Kingdom - immunohistochemistry
- Western blot
June 2005 positive
Source of outbreak or origin of infection: unknown or inconclusive.
Control measures: as a non-ambulatory or "downer" animal, the cow had been prohibited from entering the human food supply. The carcass of the animal was incinerated.
Other details/comments:
- The first detection of BSE in the United States was made in December 2003 (see Disease Information, 16 (52), 280, dated 26 December 2003, and Disease Information, 17 (1), 1, dated 2 January 2004). The animal was determined and shown to have been imported from Canada (See Disease Information, 17 (2), 3, dated 9 January 2004). This case confirms a second detection in the United States.
- Given the variation in test results for this case, the USDA has changed its testing protocol. If another BSE rapid screening test results in inconclusive findings, the United States will run both the IHC and the Western blot confirmatory tests.
*
* *
http://www.oie.int/eng/info/hebdo/AIS_64.HTM#Sec4
PRION ROUNDTABLE
Accomplished this day, Wednesday, December 11, 2003, Denver, Colorado
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
http://www.vegsource.com/talk/madcow/messages/94513.html
HISTORY OF THIS COW AND TESTING OF IT;
http://www.vegsource.com/talk/madcow/messages/94622.html
Aguzzi Letter
http://www.vegsource.com/talk/madcow/messages/94620.html
Markus Moser Prionics BSE-L
http://www.vegsource.com/talk/madcow/messages/94621.html
Q&A Dr. Jean-Philippe Deslys
snip...
> Date: Fri, 22 Apr 2005 11:53:47 -0500
> > From: "Terry S. Singeltary Sr."
> > Reply-To: Bovine Spongiform Encephalopathy
> > To:
[email protected]
> >
> >
> > ##################### Bovine Spongiform Encephalopathy
> > #####################
> >
> > Q&A Dr. Jean-Philippe Deslys
> >
> > 1. What is the standard regime for testing of suspect animals in the EU?
> >
> > The regime is an initial screening by a high-output test, the Bio-Rad
> > test. If a result raises suspicion, a confirmatory test is conducted
> > with the Western blot test.
> >
> > 2. How long has this been the case?
> >
> > Its a fairly recent development. Only recently has the Western blot
> > test become sensitive enough, with the addition of phospohtungstic acid
> > precipitation step. The Bio-Rad test (which Deslys helped develop) is
> > extremely sensitive, and the standard Western blot is extremely reliable
> > with high-signal test results. However, it had to be made more sensitive
> > for low-signal (samples with low density of malformed prions) samples.
> > It has been made more sensitive.
> >
> > Reproducibility is the problem with the IHC test. It is not
> > standardized; depending on the lab and its protocols, or even on the
> > technician involved in the test, one can get conflicting results.
> >
> > 3. Is there a way to measure the three tests in sensitivity, accuracy
> > and objectivity?
> >
> > Historically, yes. The IHC was the gold standard at one point, but we
> > have shifted to the Western blot. It requires less work, it is more
> > sensitive and its results are reproducible. IHC relies on localization.
> > If you have a weak signal case, you may get lucky and test a spot with a
> > high concentration of prions. But the opposite it true too; you can miss
> > an infection by testing a sample with low concentrations. Western blot
> > is much better for low signal situations.
> >
> > 4. The USDA in 2003 used the Western blot to confirm the BSE case in
> > Washington state, and it sent samples to the U.K. for independent
> > testing. In the case this November, which it announced was negative, it
> > instead used the IHC test and did not send samples to the U.K. Is this
> > good science?
> >
> > Its not logical. If you have two consecutive questionable screenings,
> > you do another test. I can only advise, its managements duty at USDA
> > to make the decisions. But when you have a discrepancy between the rapid
> > test and the IHC, it is only logical to confirm it with another test.
> >
> > 5. We are hearing now about a new strain of BSE, atypical BSE or aBSE.
> > Or BaSE. We have heard that IHC, the so-called gold standard, cannot
> > detect the variant. Is this true?
> >
> > Yes. There have been a few cases, one in Italy, one in Belgium, one here
> > in France. It seems to only affect very old animals. The distribution in
> > the brain is very different than we see with BSE, it looks very
> > different. The IHC test will come back negative.
> >
> > This his a very recent phenomenon. I have no opinion on its virulence.
> > We do not know where it comes from. It could be a version of sporadic
> > infection. Western blot caught them, but we would not even know it
> > existed if we werent running systematic testing in the EU.
> >
> > BSE was around for a long time before we caught it and by then, it was
> > everywhere. It had become highly infectious. It probably amplified due
> > to low-temperature rendering. The disease was recycled through the food
> > chain, and was given time to amplify. By the time it was identified,
> > even good cooking couldnt eliminate it.
> >
> > I cant stress enough that systematic testing is necessary. Withdrawing
> > all positives from the food chain is the best way to break the cycle.
> >
> > What can happen with testing of only cattle that are clearly at risk is
> > that several can remain undetected. Canada has tested about 30,000 head
> > of cattle and has three positives. That would indicate that there are
> > probably undiscovered cases. And what happens then is that the disease
> > is allowed to amplify. You have to maintain testing.
> >
> > When people choose to protect their economic interests over public
> > health, it can have a boomerang effect. It happened all through Europe.
> > They always deny; its not OUR problem, it is our neighbors problem.
> > And then a single case is discovered and the public reacts. The economic
> > results are devastating. It would be better to just assume BSE is
> > present and use systematic testing as protection. That way, the public
> > is reassured that it is not entering the food supply.
> >
> > By systematic testing, I mean doing as we do in the EU, which is to test
> > every animal over 30 months of age when it is slaughtered. In Europe,
> > three times as many cases of BSE have been caught by systematic testing
> > as by clinical testing (of clearly sick animals). In 2004, eight
> > clinical cases were discovered, 29 were discovered at rendering plants,
> > and 17 at slaughter. We should be using these tests as a weapon to
> > protect the public and to give them assurance that the food supply is
> > being protected.
> >
> > 6. USDAs list of specified risk materials excludes some products, like
> > blood and bone meal, that are banned in the EU and UK. Is our feed
> > supply safe?
> >
> > With SRMs, where do you stop? Tests have found prions in meat, nerves
> > travel through meat, and so on. The main infectivity is in the brain and
> > the spinal cord. A blood and bone meal ban in animal feed is not really
> > necessary, because except in cases of highly infective animals, it is
> > unlikely that they are dangerous in themselves. If you combine
> > systematic testing and targeted SRM removal, the brain and the spinal
> > column in cattle over 30 months, you can have a compromise that is both
> > safer and less costly than expanded feed bans.
> >
> > Certainly, you can stop the spread of BSE with a total ban on offal. But
> > it has to be a total ban. It cant be given to sheep or swine or
> > poultry. It would be very expensive and virtually impossible to
> > accomplish. You can have farmers using the wrong feed or transportation
> > errors.
> >
> > Systematic testing makes far more sense. I think of it as a thermometer.
> > It not only allows us to catch the disease, it also allows us to monitor
> > its progress. We can watch the levels of infectivity and if they start
> > going up instead of down, we can take measures.
> >
> > To an extent, our environment is contaminated. About 10 percent of wild
> > animals test positive for TSEs. If you recycle these agents, they can
> > evolve and get more dangerous. This is probably what happened with
> > BSE. It wasnt very dangerous until it evolved to the disease we know
> > today.
> >
> > People complain that testing is very expensive. It is much more
> > expensive to kill and test whole herds.
> >
> > 7. In your opinion, is infected feed the sole method of transmission of
> > BSE, apart from the very rare maternal transmission?
> >
> > Feed is the main problem. However, we are seeing some other
> > possibilities, including through fat and greases. Calves are fed milk
> > extracts, with the cream removed. To make it nutritious, they are using
> > fat and grease from cattle.
> >
> > (FOLLOW QUESTION: Would that allow BSE to develop into an infective
> > level in cattle younger than 30 months, assuming they might be getting
> > infected at a younger age?)
> >
> > 8. You were involved in a study that tested two primates who were fed
> > infected brain tissue. One eventually died of TSE; the other survived.
> > The press reported that the main finding was that it would take
> > something on the order of 1.5 kilograms of infected matter to create an
> > infection, but that seems to be an oversimplification. Could you explain
> > it further?
> >
> > The findings suggest that as little as five grams is enough to infect.
> > The 1.5 kilo figure is the amount of infected tissue that would have to
> > be ingested from an animal that would be below the threshold of
> > infection, and would test negative. In other words, even though a
> > younger animal may be developing the disease, it would take a
> > considerable amount of tissue to transmit the disease.
> >
> > An animal could be just below the testing level, and not be particularly
> > dangerous. But that is why you have to keep testing. Once it reaches the
> > threshold, it can become highly infective.
> >
> > 9. BSE is a pretty horrifying disease, but overall, it has killed less
> > than 200 humans, and only a handful in recent years. Listeria, by
> > comparison, kills thousands every year. Overall, how do you rate the
> > threat from BSE?
> >
> >
> > The overall risk is not particularly high. Over two million infected
> > animals went into the food chain in Europe, 400,000 of them before the
> > SRMs, the brains and spinal column, were removed from the carcass. Less
> > than 200 died, and less than 4,000 are at risk of developing the
> > disease. What we know now is that one particle is not going to kill you.
> > There has to be condensation of the prions to be truly dangerous.
> >
> > This is not a sterile world. But the danger is that now that the crisis
> > appears to be over, attention will turn elsewhere and that will allow
> > the disease to amplify again. Just as we stopped paying attention to
> > AIDS when medication seemed to control it, then were surprised when a
> > new and more infectious and aggressive strain appeared, we could be
> > surprised by a more serious strain of BSE. That is why I support
> > systematic testing for the long term. The object is to keep levels of
> > BSE low, and to recognize the danger if it suddenly pops back up. ...END
> >
> > TSS
> >
> > ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
> > ##########
> >
> >
> > -------- Original Message --------
> > Subject: Re: Q&A Dr. Jean-Philippe Deslys USDA REFUSAL TO USE WB ON
> > TEXAS COW WITH BSE SYMPTOMS (FULL TEXT)
> > Date: Fri, 22 Apr 2005 12:14:14 -0500
> > From: "Terry S. Singeltary Sr."
> > Reply-To: Bovine Spongiform Encephalopathy
> > To:
[email protected]
> > References:
[email protected].
snip...end...full...text;
http://www.vegsource.com/talk/madcow/messages/94629.html
BIO-RAD
> > -------- Original Message --------
> > Subject: USA BIO-RADs INCONCLUSIVEs
> > Date: Fri, 17 Dec 2004 15:37:28 -0600
> > From: "Terry S. Singeltary Sr."
> > To:
[email protected]
> >
> >
> >
> > Hello Susan and Bio-Rad,
> >
> > Happy Holidays!
> >
> > I wish to ask a question about Bio-Rad and USDA BSE/TSE testing
> > and there inconclusive. IS the Bio-Rad test for BSE/TSE that
complicated,
> > or is there most likely some human error we are seeing here?
> >
> > HOW can Japan have 2 positive cows with
> > No clinical signs WB+, IHC-, HP- ,
> > BUT in the USA, these cows are considered 'negative'?
> >
> > IS there more politics working here than science in the USA?
> >
> > What am I missing?
> >
> >
> >
> > -------- Original Message --------
> > Subject: Re: USDA: More mad cow testing will demonstrate beef's safety
> > Date: Fri, 17 Dec 2004 09:26:19 -0600
> > From: "Terry S. Singeltary Sr."
> > snip...end
> >
> >
> > Experts doubt USDA's mad cow results
>
>
>
> snip...END
>
> WELL, someone did call me from Bio-Rad about this,
> however it was not Susan Berg.
> but i had to just about take a blood oath not to reveal
> there name. IN fact they did not want me to even mention
> this, but i feel it is much much to important. I have omitted
> any I.D. of this person, but thought I must document this ;
>
> Bio-Rad, TSS phone conversation 12/28/04
>
> Finally spoke with ;
>
>
> Bio-Rad Laboratories
> 2000 Alfred Nobel Drive
> Hercules, CA 94547
> Ph: 510-741-6720
> Fax: 510-741-5630
> Email: XXXXXXXXXXXXXXXXXX
>
> at approx. 14:00 hours 12/28/04, I had a very pleasant
> phone conversation with XXXX XXXXX about the USDA
> and the inconclusive BSE testing problems they seem
> to keep having. X was very very cautious as to speak
> directly about USDA and it's policy of not using WB.
> X was very concerned as a Bio-Rad official of retaliation
> of some sort. X would only speak of what other countries
> do, and that i should take that as an answer. I told X
> I understood that it was a very loaded question and X
> agreed several times over and even said a political one.
>
> my question;
>
> Does Bio-Rad believe USDA's final determination of False positive,
> without WB, and considering the new
> atypical TSEs not showing positive with -IHC and -HP ???
>
> ask if i was a reporter. i said no, i was with CJD Watch
> and that i had lost my mother to hvCJD. X did not
> want any of this recorded or repeated.
>
> again, very nervous, will not answer directly about USDA for fear of
> retaliation, but again said X tell
> me what other countries are doing and finding, and that
> i should take it from there.
> "very difficult to answer"
>
> "very political"
>
> "very loaded question"
>
> outside USA and Canada, they use many different confirmatory tech. in
> house WB, SAF, along with
> IHC, HP, several times etc. you should see at several
> talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS
> NEGATIVE. again, look what
> the rest of the world is doing.
> said something about Dr. Houston stating;
> any screening assay, always a chance for human
> error. but with so many errors (i am assuming
> X meant inconclusive), why are there no investigations, just false
> positives?
> said something about ''just look at the sheep that tested IHC- but were
> positive''. ...
>
>
> TSS
>
> -------- Original Message --------
> Subject: Your questions
> Date: Mon, 27 Dec 2004 15:58:11 -0800
> From: To:
[email protected]
>
>
>
> Hi Terry:
>
> ............................................snip Let me know your phone
> number so I can talk to you about the Bio-Rad BSE test.
> Thank you
>
> Regards
>
>
>
> Bio-Rad Laboratories
> 2000 Alfred Nobel Drive
> Hercules, CA 94547
> Ph: 510-741-6720
> Fax: 510-741-5630
> Email: =================================
>
>
> END...TSS
>
>
> ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
##########
>
> =====================================================
> =====================================================
>
> END....TSS
>
FULL TEXT;
http://www.vegsource.com/talk/madcow/messages/94627.html
Effect of Tissue Deterioration on Postmortem BSE Diagnosis by
Immunobiochemical Detection of an Abnormal Isoform of Prion Protein
Hiroko HAYASHI1), Masuhiro TAKATA1), Yoshifumi IWAMARU1), Yuko USHIKI1)2),
Kumiko M. KIMURA1), Yuichi TAGAWA1), Morikazu SHINAGAWA1) and Takashi
YOKOYAMA1)
1) Prion Disease Research Center, National Institute of Animal Health
2) Nippi Research Institute of Biomatrix
(Received 25-Aug-2003)
(Accepted 14-Jan-2004)
ABSTRACT. Surveillance for bovine spongiform encephalopathy (BSE) in fallen
stock in Japan is conducted with a commercial enzyme-linked immunosorbent
assay (ELISA) for mass screening, with Western blotting (WB) and
immunohistochemistry performed for confirmation of the ELISA. All tests are
based on immunological detection of an abnormal isoform of the prion protein
(PrPSc) in brain tissues, which have sometimes deteriorated by the time
samples from fallen stock reach a diagnostic laboratory. To evaluate BSE
surveillance procedures for fallen stock, we examined PrPSc detection from
artificially deteriorated BSE-affected bovine brain tissues with a
commercial ELISA kit and compared the results with those of WB. The optical
density (OD) values of the ELISA decreased with advancing deterioration of
the tissues, whereas no reduction in the signal for PrPSc was observed in
WB, even when performed after 4 days of incubation at 37°C. The progressive
decrease in the OD values in the ELISA appear to be caused by a partial loss
of the N-terminal moiety of PrPSc due to digestion by endogeneous and/or
contaminated microbial enzymes, and by the presence of ELISA inhibitors that
are generated in deteriorated tissues. These results suggest that WB is the
most reliable test for fallen stock, especially for cattle brains within
decaying carcasses.
KEY WORDS: BSE, ELISA, PrPSc, Western blot
[PDF (96K)] [References]
To cite this article:
Hiroko HAYASHI, Masuhiro TAKATA, Yoshifumi IWAMARU, Yuko USHIKI, Kumiko M.
KIMURA, Yuichi TAGAWA, Morikazu SHINAGAWA and Takashi YOKOYAMA "Effect of
Tissue Deterioration on Postmortem BSE Diagnosis by Immunobiochemical
Detection of an Abnormal Isoform of Prion Protein". J. Vet. Med. Sci.. Vol.
66: 515-520. (2004) .
http://www.jstage.jst.go.jp/article/jvms/66/5/66_515/_article
FULL TEXT PDF;
Another problem in testing fallen stock for BSE may arise from unequal
distribution of PrPSc in BSE-affected brains. Spongiform changes and
accumulation of PrPSc are most frequently observed in the obex region [15,
18], but, it could be quite difficult to collect the obex region precisely
from extensively deteriorated and liquefied brain tissue. Furthermore, in
such cases it would be difficult to perform IHC as a confirmation test.
It has been shown that sample autolysis does not affect detection of PrPSc
by means of WB [3, 5, 13]. Our WB results also demonstrated no reduction in
the PrPSc signal as a result of deterioration at 30*C or 37*C for up to 4
days, as so far examined (Figs. 2A and 3A). In this study, we showed that
several problems undermine the utility of the ELISA with deteriorated
samples, whereas WB remains very dependable. Therefore, WB might be the only
reliable procedure to detect PrPSc in severely damaged samples from fallen
stock...
FULL TEXT 6 PAGES;
http://www.jstage.jst.go.jp/article/jvms/66/5/515/_pdf
From: Terry S. Singeltary Sr. [
[email protected]]
Sent: Tuesday, July 29, 2003 1:03 PM
To:
[email protected]
Cc:
[email protected];
[email protected].; BSE-L
Subject: Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION
TO DOCKET 2003N-0312]
Greetings FDA,
snip...
PLUS, if the USA continues to flagrantly ignore the _documented_ science to
date about the known TSEs in the USA (let alone the undocumented TSEs in
cattle), it is my opinion, every other Country that is dealing with BSE/TSE
should boycott the USA and demand that the SSC reclassify the USA BSE GBR II
risk assessment to BSE/TSE GBR III 'IMMEDIATELY'. for the SSC to _flounder_
any longer on this issue, should also be regarded with great suspicion as
well. NOT to leave out the OIE and it's terribly flawed system of disease
surveillance. the OIE should make a move on CWD in the USA, and make a risk
assessment on this as a threat to human health. the OIE should also change
the mathematical formula for testing of disease. this (in my opinion and
others) is terribly flawed as well. to think that a sample survey of 400 or
so cattle in a population of 100 million, to think this will find anything,
especially after seeing how many TSE tests it took Italy and other Countries
to find 1 case of BSE (1 million rapid TSE test in less than 2 years, to
find 102 BSE cases), should be proof enough to make drastic changes of this
system. the OIE criteria for BSE Country classification and it's
interpretation is very problematic. a text that is suppose to give
guidelines, but is not understandable, cannot be considered satisfactory.
the OIE told me 2 years ago that they were concerned with CWD, but said any
changes might take years. well, two years have come and gone, and no change
in relations with CWD as a human health risk. if we wait for politics and
science to finally make this connection, we very well may die before any
decisions
or changes are made. this is not acceptable. we must take the politics and
the industry out of any final decisions of the Scientific community. this
has been the problem from day one with this environmental man made death
sentence. some of you may think i am exaggerating, but you only have to see
it once, you only have to watch a loved one die from this one time, and you
will never forget, OR forgive...yes, i am still very angry... but the
transmission studies DO NOT lie, only the politicians and the industry do...
and they are still lying to this day...TSS
http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt
still disgusted in Bacliff, Texas...TSS