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From: TSS ()
Subject: Re: Transcript of conference with media of Johann et al on the latest BSe in USA Release No. 0233.05
Date: June 25, 2005 at 2:13 pm PST

Greetings,

A few comments please;

>>>REPORTER: "Mr. Secretary, Dr. Clifford in the Friday teleconference we all remember so well mentioned (unclear) in general about the possibility of atypical case. Is there anything to suggest that would be the case here or is this a case of something kind of sticking out -- <<<

>>>SEC. JOHANNS: "Go ahead.<<<

>>>DR. CLIFFORD: "The molecular protein patterns of this particular BSE case were very much like some that have been found in France, not those found typically in the UK. However, there's a lot to be learned about the phenotypic expression of BSE that's unknown. So for the purposes of internationally, this is a case of BSE.<<<

>>>"We would describe this as a case of BSE with a molecular pattern that differs from those that you would see classically from the UK. <<<


Greetings again,


THE molecular protein patterns of the cattle at Mission Texas were much different too. so, i would be curious if there is any comparison;


>> Differences in tissue distribution could require new regulations
>> regarding specific risk material (SRM) removal.

snip...end

full text ;

http://www.bseinquiry.gov.uk/files/mb/m11b/tab01.pdf


It was, however, performed in the USA in 1979, when it was shown that cattle inoculated with the scrapie agent endemic in the flock of Suffolk sheep at the United States Department of Agriculture in Mission, Texas, developed a TSE quite unlike BSE. 32

http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm#820543


The findings of the initial transmission, though not of the clinical or neurohistological examination, were communicated in October 1988 to Dr Watson, Director of the CVL, following a visit by Dr Wrathall, one of the project leaders in the Pathology Department of the CVL, to the United States Department of Agriculture. 33


http://www.bseinquiry.gov.uk/report/volume2/chaptea3.htm#820546


The results were not published at this point, since the attempted transmission to mice from the experimental cow brain had been inconclusive. The results of the clinical and histological differences between scrapie-affected sheep and cattle were published in 1995. Similar studies in which cattle were inoculated intracerebrally with scrapie inocula derived from a number of scrapie-affected sheep of different breeds and from different States, were carried out at the US National Animal Disease Centre. 34

Greetings again,


> The results were not published at this point, since the attempted transmission

> to mice from the experimental cow brain had been inconclusive

> The results, published in 1994, showed that this source of scrapie agent,


> though pathogenic for cattle, did not produce the same clinical signs of brain lesions characteristic of BSE.

http://www.bseinquiry.gov.uk/

OR, what about Japan atypical cases. here we have a case where they find the BSE/TSE agent in the

WHY is USA insisting _now_ not to use WB, when on the 1st _confirmed_ case Dec. 23, 2003
USA mad cow, WB was used ???

maybe this is the reason ;

JAPAN BSE # 8 & 9 cow

8. 6/10/2003 Holstein Steer 13/10/2001 23 mths
No clinical signs WB+, IHC-, HP-


9. 4/11/2003 Holstein Steer 13/1/2002
21 mths No clinical signs WB+, IHC-, HP-

===========

More information on the first 11 Japanese BSE-cases can be found on the website of the Japanese Embassy in the US:

http://www.us.emb-japan.go.jp/english/html/fafacts/bse/bse.htm


ORAL 8

Bovine spongiform encephalopathy (BSE) in Japan

Takashi Yokoyama, Kumiko M. Kimura, Morikazu Shinagawa
Prion Disease Research Center, National Institute of Animal Health, Japan

Bovine spongiform encephalopathy (BSE) has become an important problem
not only for animal industry, but
also for public health. In Japan, BSE was first recognized in September
2001 by fallen stock surveillance.
Since October 2001, BSE examination for all cattle slaughtered at
abattoirs has started. In April 2004, all dead
cattle examination (over 24 months) has been conducted at livestock
hygiene service center. Samples positive
in enzyme linked immunosorbent assay (ELISA) are further subjected to
western blot (WB) and
immunohistochemistry (IHC). Thirteen BSE cases have been reported by
September 2004. Twelve cases
were classified as typical BSE, and the remained one was an atypical
BSE. Variant forms of BSE with atypical
histopathological and/or biochemical phenotype were reported in Italy
and France. Further study is required
for BSE prion characteristics.
To characterize BSE prion properties, brain homogenates of Japanese BSE
cases were intracerebrally
inoculated into wild-type mice. The first case (BSE/Chiba) was
successfully transmitted to rodents. The mean
incubation periods (409.0 days) in this experiment was preferably longer
than that of previously reported.
PrPSc distribution, prion titer, mice susceptibility and/or storage
condition of sample might be influenced the
result. Recently, we introduced transgenic mice that overexpress a
bovine PrP gene to overcome the species
barrier problem. These mice are expected to accelerate the transmission
experiment of BSE prion.
Transmission of atypical BSE case is undergoing by using these
transgenic mice.

Department of Prion Research
Tohoku University School of Medicine
2-1 Seiryo-cho Aoba-ku, Sendai 980-8575, JAPAN
Tel: +81-22-717-8233
Fax: +81-22-717-8148


In Reply to: Re: Detection of prion in peripheral nerve (11th BSE case of Japan) posted by TSS on November 8, 2004 at 8:16 am:

Japan Consumer Press online
Nippon shouhisha shinbun
http://www.jc-press.com/eg.htm
http://www.jc-press.com/En/Latest%20News/200411/20041109BSE%20death%20cow%27s%20anomalous%20prion.htm
Last modified, 11/09/2004 13:42:49
BSE death cow's anomalous prion detected from peripheral nerve tissue,
suprarenal gland
First time from non-Specified Risk Material, or SRM
By JCPRESS
National Institute of Animal Health Animal announced on November 1 that it had detected the anomalous prion protein that was the etiologic agent of the mad cow disease, or BSE, or bovine spongiform encephaalopathy, from the peripheral nerve tissue and the suprarenal gland of the cow of the age in the mad cow disease for the dying infection 94 months on March 9 this year.
Japan is obligating the removal of the Specified Risk Material, or SRM such as the head, the spinal cord, the vertebral columns, and the small
intestines that accumulate the anomalous prion protein easily as a BSE
(bovine spongiform encephaalopathy) measures.
Because the mad cow disease etiologic agent was detected from a tissue
different from the Specified Risk Material, or SRM, the review of the
Specified Risk Material, or SRM might be urged on the Japanese Government.
International Symposium of PRION DISEASES for food and drug safety
http://www.knt.co.jp/ec/2004/prion/
national institute of animal health(only in Japanese)
http://niah.naro.affrc.go.jp/index-j.html
The statement of the Ministry of Health, Labour and Welfare
(only in Japanese)
http://www.maff.go.jp/www/press/cont2/20041101press_7.htm
Yomiuri on line (only in Japanese)
http://www.yomiuri.co.jp/science/news/20041102i503.htm
Asahi on line(only in Japanese)
http://www.asahi.com/special/bse/TKY200411010291.html
Mainichi on line(only in Japanese)
http://www.mainichi-msn.co.jp/shakai/jiken/disease/news/20041102ddm041040128000c.html

>>>SEC. JOHANNS: "We're just not going to confirm anything about the animal until we get the epidemiological work done. And I hope you understand we want to be very, very careful about that.

REPORTER: "Why? <<<


I AGREE, why not, you have had 7 or 8 months already. Incinerated the complete cow (or so you claim) so there is
is no evidence or other tissue samples to be sent around the world to study this supposedly atypical BSE case. then froze the few grams of tissue sample you did have so as to destroy further evidence, when proper BSE protocol calls for it NOT to be frozen and ample material taken for further testing if inconclusive is the case, were never followed. were they ever intended to be followed? YOU fumbled the ball again USDA/APHIS/FDA. YOU move the goal posts any time you wish, does not matter what quarter of the game we are in. YOU have lost all credibility with the world. All this, and you blame Phylis Fong and the GAO? Simply not so. You only have to look in the mirror, but while contiplating, consider the millions and millions you are responsible for exposing this deadly agent too via a multitude of routes and sources.

>>>DR. CLIFFORD: "As far as the case of spontaneous, that's a theory. It's one that has not been proven. It may or may not be correct or accurate.<<<

>>>"As far as how much bad feed may be gone out there undetected, we have tested over 388,000 samples from a high-risk population. If there was large numbers of BSE cases in the United States, we would have detected them.<<<

>>>"The IHC test here has been used on three samples. That biorad or rapid screening test detected the sample. The biorad test is widely used internationally and has a high degree of sensitivity." <<<


THOSE 388,000 TEST ARE MEANINGLESS. they must be retested properly.
THE Bio-Rad test is only as good and as sensitive as the one giving the test and as bad as this testing was flubbed, one only wonders about the rest of those 388,000 head of cattle. for goodness sake, if they cant follow proper protocol about freezing tissue sample and taking enough sample material, then i wonder very seriously about the rest of the testing protocols. with this
unreported 3 POSITIVE test on this cow out of Ames, just makes one ponder even further about those other 388,000 rapid tests with those crappy weak antibodies. these weak antibodies were there assurance that Bio-Rad would never confirm a case of BSE/TSE in the USA.


AS Sentor Waxman stated, there must be an investgation into the failer of this BSE/TSE testing protocol.
HEADS SHOULD ROLL. enough is enough.


>>>And here a year later I can stand in front of people and say, this is what we've found. Now, those questions I think were great questions a year ago, but we have irrefutable scientific proof that we've done all these tests and this is really what we've come down to. <<<

>>>"The science very, very clearly is on our side here. There just isn't any doubt about it, and that's what we try to urge people to do is focus on the science, the testing process, the removal of the SRMs, the ruminant-to-ruminant feed ban. <<<


I hate to be the one that tells Johann, but the USA is still feeding ruminants to ruminants in 2005. THE Aug. 4, 1997 runimant to ruminant feed ban was nothing more than ink on paper that was not enforceable. it was voluntary and partial.

NONE of this would have been done without GAO and OIG investigations and repremands and then USDA/APHIS et al insist on not going by sound science. INSTEAD they wish to go by the OIE guidelines, which by the way, all other documented BSE countries went by those same guidelines. These guidelines are terribly flawed and are designed on NOT finding BSE/TSE. These OIE BSE/TSE guidelines were designed for the legal trading of all animal TSEs. There is no sound BSE/TSE science there.


>>>"Our scientists agree that the freezing did not compromise the integrity of the sample. The IG does not dispute that conclusion, but because freezing can compromise the sample and our protocol indicates samples should not be frozen, I am dispatching USDA's staff to go over the protocols at the locations where samples are collected to ensure that the samples are not frozen.<<<

>>>"The second concern the IG expressed and the last one on my list relates to inadequate paperwork. When the IHC test was conducted in November, no formal report was completed. The results were relayed as you know, but the paperwork was not finished. Clearly, documentation is an important component of sensitive scientific activity. Completing the paperwork is necessary. I've stressed the importance of complete and accurate documentation, and I've directed our administrators to spot-check lab activity to make sure that the reports are completed in the future.<<<

>>>"Now if I might just wrap up my comments with a little bit of perspective. We can discuss the differing test results, we can debate the best use of antibodies two years ago, now, and in the future, but we must remember that we are talking about a single case, one sample, and it has been subject now to a tremendous amount of testing.<<<

>>>"In fact in my meeting with the Inspector General and her staff I was assured that the protocols were followed in the cases they examined except this one.<<<


FDA Statement
FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow with central nervous system symptoms had been killed and shipped to a processor for rendering into animal protein for use in animal feed.

FDA, which is responsible for the safety of animal feed, immediately began an investigation. On Friday and throughout the weekend, FDA investigators inspected the slaughterhouse, the rendering facility, the farm where the animal came from, and the processor that initially received the cow from the slaughterhouse.

FDA's investigation showed that the animal in question had already been rendered into "meat and bone meal" (a type of protein animal feed). Over the weekend FDA was able to track down all the implicated material. That material is being held by the firm, which is cooperating fully with FDA.

Cattle with central nervous system symptoms are of particular interest because cattle with bovine spongiform encephalopathy or BSE, also known as "mad cow disease," can exhibit such symptoms. In this case, there is no way now to test for BSE. But even if the cow had BSE, FDA's animal feed rule would prohibit the feeding of its rendered protein to other ruminant animals (e.g., cows, goats, sheep, bison).

FDA is sending a letter to the firm summarizing its findings and informing the firm that FDA will not object to use of this material in swine feed only. If it is not used in swine feed, this material will be destroyed. Pigs have been shown not to be susceptible to BSE. If the firm agrees to use the material for swine feed only, FDA will track the material all the way through the supply chain from the processor to the farm to ensure that the feed is properly monitored and used only as feed for pigs.

To protect the U.S. against BSE, FDA works to keep certain mammalian protein out of animal feed for cattle and other ruminant animals. FDA established its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that the disease spreads by feeding infected ruminant protein to cattle.

Under the current regulation, the material from this Texas cow is not allowed in feed for cattle or other ruminant animals. FDA's action specifying that the material go only into swine feed means also that it will not be fed to poultry.

FDA is committed to protecting the U.S. from BSE and collaborates closely with the U.S. Department of Agriculture on all BSE issues. The animal feed rule provides crucial protection against the spread of BSE, but it is only one of several such firewalls. FDA will soon be improving the animal feed rule, to make this strong system even stronger.

####


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

>>>"And animals in the United States move all across the country. They might be born in one state; they might be fed to a certain weight in another state. They might be fed out in another state and slaughtered yet in a fourth state. And that would not be an unusual situation with our beef industry.<<<


NO need for traceability either, right! all in all, i would give the USDA/APHIS et al a F- in there June 2004 Enhanced BSe cover-up plan. They would make the 3 stooges or Laural and Hardy look like real scientist. ...


TSS


Terry S. Singeltary Sr.
Bacliff, Texas USA 77518


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Friday, June 24, 2005 10:03 PM
Subject: Transcript of conference with media of Johann et al on the latest BSe in USA Release No. 0233.05


##################### Bovine Spongiform Encephalopathy #####################

Transcript
Release No. 0233.05
Contact:
USDA Press Office (202) 720-4623


TRANSCRIPT OF MEDIA CONFERENCE WITH REMARKS MADE BY AGRICULTURE SECRETARY MIKE JOHANNS, DR. JOHN CLIFFORD, CHIEF VETERINARY OFFICER, ANIMAL PLANT HEALTH INSPECTION SERVICE, AND DR. DANNY MATTHEWS, TSE PROGRAM MANAGER, VETERINARY LABORATORIES AGENCY, WEYBRIDGE, ENGLAND - WASHINGTON D.C. - JUNE 24, 2005
SEC. JOHANNS: "Thank you everyone for your patience. I appreciate it immensely. I am joined for today's news conference by Dr. John Clifford, our chief veterinarian at APHIS; and by also on the telephone Dr. Danny Matthews who is an internationally respected scientist from the Veterinary Laboratories Agency in Weybridge, England. And as I said, he joins us on the line.

"I asked Dr. Matthews to join me for a couple of reasons-- first to ensure that I accurately relay the test results and information he has provided and then, secondly, because he is recognized worldwide as an expert in this area, so he brings independent perspective to our discussion. And again, I thank you for being here.

"Today I do have quite a bit of information to share with you including the test results from England and some changes to USDA protocols for BSE testing. So I'll just get started.

"Let me say at the outset that the USDA has spent a tremendous amount of time on this issue. Secretary Veneman did before me, and I have, and certainly our scientists have, and today I'm going to share what I've learned, the concerns that I've raised and the steps that I intend to address those concerns.

"So let me start first with the test results. As you are aware, last November we had an inconclusive report from a rapid screening test. USDA then conducted two IHC confirmatory tests, and both came out negative. A few weeks ago an additional confirmatory test was conducted, and that test is referred to as the Western blot test.

"On June 10 I learned that test was reactive and shared those results at that time.

"We now have the test results from the lab in Weybridge, England, as well as the results from additional testing in our own lab, and again I am here today to share those results with you.

"The results confirm the presence of BSE in this animal, an animal that was blocked from entering the food supply thanks to the firewalls that are in place. It is critically important to note that this animal was identified as a high risk animal. A sample was taken, and the carcass was incinerated.

"These steps ensured that it would never impact human health or animal health.

"It is also important to remember that we are currently testing about 1,000 cattle per day. That's nearly 400,000 total to date, as a part of a BSE enhanced surveillance program. Frankly we have said all along that we expected additional positive test results. One positive result out of 388,000 tests in our enhanced surveillance program indicates that the presence of the disease is extremely, extremely low in the United States.

"The fact that this animal was blocked from entering the food supply tells us that our safeguards are working exactly as they should.

"I'd like to talk to you for a moment about some details of the test results if I might. All of the tests came out positive except a rapid Western blot test. Among the tests conducted at the Weybridge lab was an additional IHC confirmatory test that came back positive.

"As you will recall as I mentioned in my opening comments, our IHC confirmatory tests came back negative. I bring this to your attention because the experts tell me that the differing results do not necessarily mean error. There are a lot of factors involved.

"We are working with Dr. Matthews and his team to develop a fact sheet that explains those factors in detail -- which we will make available on our website if it's not there already. For now, bear with me as I try to walk through this in laymen's terms.

"The Weybridge lab indicates that this animal has a very low level of abnormal prion protein in the brain, making them more difficult to detect. Additionally, the abnormalities were isolated-- in other words, not consistent throughout the brain -- making it possible for one sample to test negative while another sample might test positive.

"Here's another point that I found very interesting. This isn't a test where a scientist can just open up a catalog and purchase the IHC test. It's not a standardized test as such. The tests are assembled, for lack of a better term again using laymen's words here, at a local laboratory. In the United States, that laboratory here is in Ames, Iowa.

"There are variables which include different types of antibodies which can be used under OIE guidelines, international guidelines. The antibody is what detects the abnormalities in the brain. The fact that USDA used a different antibody than that used at Weybridge could also account for differing results.

"Hopefully that helps you to understand how and why IHC tests can sometimes produce varying results. It is important for you to know that the Weybridge experts reviewed USDA's November IHC confirmatory test, and they reached the same conclusion.

"As I mentioned, the other internationally accepted confirmatory test, the SAF Western blot, also detected BSE in this animal. That's why after careful consideration and consultation with scientists I am calling for a change in our testing. I have directed our scientists to work with international experts to develop protocol for simultaneously performing the IHC and the Western blot test in the event of another inconclusive screening test.

"I have also called for a careful analysis of the antibodies we are using to conduct the IHC test to make sure that we're using the most current and the best option.

"I must admit that when I first heard that the antibody we use is different from the antibody used at the Weybridge lab, I wondered about whether that was a flaw in the IHC testing. But I am told that it is not. Dr. Matthews assures me that even at their world-renowned lab they conduct periodic reviews of the variants used in the IHC test including the antibodies. In fact we're talking about having USDA scientists participate in those reviews to ensure our tests are in line with the very latest science.

"In other words, the protocol we developed just a few years ago to conduct the test, including the type of antibody used, might not be the best option today. Likewise, the protocol we develop as a result of this testing might not be the best option in 2007.

"Science is ever evolving. It is not static. And as we learn more we apply the knowledge. Having said all of that about the IHC, perhaps the most important thing to remember is that we've only needed this test three times since our enhanced surveillance began. Three times out of 388,309 tests, three times that we have had inconclusive screening results. And I'm told that the reliability of the screening test is very sound.

"We use something called the biorad ELISA test in our enhanced surveillance program. Dr. Matthews has indicated that he agrees with USDA scientists who believe biorad ELISA is a very effective screening test.

"Now if I might take a few moments to broaden the discussion. As you know, I was confirmed in January so I was not a part of the USDA team when this case started out in November. Because of that and the more recent testing, I asked for a comprehensive review of the events and activities since the inconclusive November test. I have reviewed the reports and conducted several meetings with the Inspector General as well as our scientists, and I've identified four areas of concern for me.

"I'm going to be very straightforward in discussing them and in my response to those issues. The first relates to the way parts of the carcass were identified and stored while the testing was being conducted in November. Parts of this animal were stored with those of four other animals, making it difficult to isolate the parts of the animal.

"The right steps were taken to address the concern. The five carcasses were all incinerated; ensuring that there was absolutely no risk of this animal entering the human food or animal feed supplies. Additionally a corrective action plan was developed and carried out to tighten the controls at the facility.

"I want to make sure that quality controls are equally tight at the other locations where samples are being taken and tested, so I'm directing APHIS to conduct an analysis of the sampling and segregation procedures so we can ensure accuracy. While the problem was appropriately addressed in this case, it's important that we be precise.

"My second concern relates to an experimental test that was run on this sample back in November in addition to the standard test. A sample this sensitive should not be subjected to additional tests for research purposes without specific protocol to guide that action.

"To address the issue I have directed our scientists to again work with international experts to develop protocol that ensures tremendous thought is given to the appropriate handling of a sample once it has generated an inconclusive result.

"I also want to mention that the experimental test revealed abnormalities. Because the test was not validated and because it followed the two approved IHC tests that came out negative, the results were not reported out of the lab. Again, appropriate protocols relating to additional testing for research will prevent a similar situation in the future.

"During the course of my review I met several times with the Inspector General and her staff, and they've boiled it down to two additional concerns relating to protocols. One concern is the freezing of this sample, because it's not consistent with guidelines.

"Our scientists agree that the freezing did not compromise the integrity of the sample. The IG does not dispute that conclusion, but because freezing can compromise the sample and our protocol indicates samples should not be frozen, I am dispatching USDA's staff to go over the protocols at the locations where samples are collected to ensure that the samples are not frozen.

"The second concern the IG expressed and the last one on my list relates to inadequate paperwork. When the IHC test was conducted in November, no formal report was completed. The results were relayed as you know, but the paperwork was not finished. Clearly, documentation is an important component of sensitive scientific activity. Completing the paperwork is necessary. I've stressed the importance of complete and accurate documentation, and I've directed our administrators to spot-check lab activity to make sure that the reports are completed in the future.

"Now if I might just wrap up my comments with a little bit of perspective. We can discuss the differing test results, we can debate the best use of antibodies two years ago, now, and in the future, but we must remember that we are talking about a single case, one sample, and it has been subject now to a tremendous amount of testing.

"In fact in my meeting with the Inspector General and her staff I was assured that the protocols were followed in the cases they examined except this one. I have already outlined their concerns and mine about this issue. Remarkably after conducting 388,000 tests under our enhanced surveillance program we have only had three inconclusive tests. Only three times have we needed to engage the protocols for confirmatory testing, extremely rare. And only one of those has come back positive, one out of 388,000.

"U.S. beef is safe, plain and simple. Nothing about the events of the past few weeks nor today's announcement should change in any way the confidence we have in our beef supply. I enjoyed beef this noon for lunch. It is the safest in the world, and I will continue to enjoy beef. As many of you have come to understand, I tend to tell it like it is.

"This is as straightforward as I can get it. The BSE threat to humans in this country is so remote that there's a better chance you'll get hurt crossing the street to get to the grocery store than by the beef you buy in the grocery store.

"Frankly, it is a remarkable testimony to the effectiveness of the interlocking safeguards that one case of BSE is discovered among 388,000 samples collected in the past year. All the necessary steps were also taken to protect public health.

"None of the concerns I have outlined impacted public health, which of course is our top priority. So there is absolutely no question in my mind that Americans can and should continue to be very confident in their beef supply.

"And the same is true for our international friends. I appreciate the calm, the very thoughtful reactions we've heard from many of our trading partners including Japan and Canada. At a time when some countries are dealing with dozens or even hundreds of cases of BSE, the international community recognizes that the key issue is whether the food supply is protected, and ours clearly is.

"They are basing their decisions on science, the international language, and that's exactly what we have asked them to do because science clearly indicates that the safety of our beef is there. This case supports that conclusion, recognizing that this animal was blocked from both the human food supply and the animal feed supply.

"The carcass was incinerated to ensure it did not and could not pose any kind of threat to public health. I was very reassured when Dr. Matthews told me that in the international community our credibility is enhanced by this testing.

"We also have our firewalls, and they are always worth mentioning. They include our ban on specified risk materials from the food supply, our ruminant-to-ruminant feed ban that has been in place now for many years, our strict slaughter guidelines.

"Now with that, ladies and gentlemen, what I would like to do is ask Dr. Danny Matthews from the Veterinary Laboratories Agency in Weybridge, England, to chime in. I might mention that Dr. Matthews and I have shared some of the things that we have discussed today. And again, he will be very, very helpful in terms of bringing perspective to this issue.

"Regarding the different IHC test results, what I would like to do is have the doctor start with that and then talk about and quantify the human health risk relative to BSE, not only in this country but for that matter worldwide, if he can.

"So Dr. Matthews, we would like you to go ahead and get started.

DR. DANNY MATTHEWS: "Thank you. The line is breaking up intermittently, so I'm hoping I've picked up on the key issues that you wanted me to contribute on, one being the differences in IHC protocols.

SEC. JOHANNS: "Doctor, go ahead.

OPERATOR: "Go ahead, Mr. Matthews.

DR. MATTHEWS: "Okay. Sorry. Firstly, the different IHC protocols and then try and quantify the human health risks.

"Now, there are no two laboratories around the world that are using identical IHC methods and not a single test that you can take off the shelf. And in fact there's been quite a lot of resistance in Europe when there was an attempt to see if there was any scope for having a common protocol. In some cases just variations in water content can actually mean that your test does not perform equally. So it really is appropriate for each laboratory to develop the test that works best for them.

"The key to this is that you're able to compare it with the performance of other laboratories against some standard reference material. So the fact that Ames has got a different protocol to ours does not suggest --

SEC. JOHANNS: "The line is breaking up. Go ahead.

OPERATOR: "Go ahead, Mr. Matthews.

DR. MATTHEWS: "I think what one needs to do is obviously look at what went wrong. Firstly the different IHC protocols identify (unclear) human health --

"I'm getting some feedback here. I'm afraid I'm hearing myself. Conducting an IHC test is a bit like baking a cake. The antibody is critical --

OPERATOR: "Excuse me. Sorry, I do apologize. If you could please continue to stand by. One moment. If all participants could please continue to hold, we're working out some technical issues with the audio. Thank you. Please continue holding.

SEC. JOHANNS: "Why don't we start with the doctor, and then if we can't get a clear voice from Dr. Matthews we'll go ahead and take your questions. Go ahead.

DR. CLIFFORD: "Thank you, Mr. Secretary. I would like to reiterate what was stated earlier by the Secretary. This result is not an unexpected occurrence in a testing program of this magnitude. Again we are currently testing nearly 1,000 animals a day as part of our surveillance effort. It's not surprising that we would find additional cases of the disease in a targeted program of this size.

"In fact that's what this program is designed to do. Our goal is to get the data we need to make meaningful estimates about the rate of prevalence in the United States. By any measure, that prevalence is extremely low. The goal of our program is to find out just how low and we are very encouraged by what we found so far.

"In regard to the overall nature of the testing protocol we've had in place, I would just like to say that it's normal for testing protocols for diseases to evolve along with knowledge about those diseases and how they affect the population.

"There are several different sound protocols used around the world for BSE, and one of them is the one we have been using in the U.S. as the IHC is the preferred confirmatory test as BSE.

"The question then becomes though, is a different protocol fit for the U.S.? As Secretary Johanns has stated, we'll now be running the Western blot alongside the IHC as part of our testing protocol. This is not to say that the IHC isn't a good test. It is a good test, an internationally accepted one, and we will continue to use it. But the use of the Western blot alongside it will provide an additional level of assurance to our efforts.

"We'll also be working with Weybridge scientists on proficiency testing to ensure that our testing protocol and laboratory procedures remain robust as they can be.

"As to the epidemiological work, we are quite certain we have identified the herd of origin of this animal but we want to be sure. So we're doing DNA testing. And the reason is, it's important not because we would just expect to find one more BSE animal associated with this herd. On the contrary, experience worldwide has shown that it is highly unusual to find more than one BSE animal in a herd.

"The value of identifying the herd lies in looking at the type of sources of feed the herd would have been exposed to and any other possible explanations for how the animal would have gotten BSE.

"With that, I will turn it back to you, Mr. Secretary.

SEC. JOHANNS: "Dr. Matthews? Any chance he's on? No. Okay. I'll start with you.

REPORTER: "Mr. Secretary, Randy Fabi with Reuters.

SEC. JOHANNS: "Hi, Randy.

REPORTER: "You haven't said anything about the animal itself. Can you tell us where it was born (unclear)?

SEC. JOHANNS: "The animal as you know is -- well not the animal but we're now going through the process of some DNA testing. And until we complete that we just aren't going to have anything new to offer. As the doctor indicated, we want to be as sure as we can about the animal and we are putting together information. The doctor did indicate when we made the first announcement that at least at this point we don't have any evidence that this was an imported animal. And we can repeat that.

"Yes?

REPORTER: (off-mike)

SEC. JOHANNS: "It shouldn't. This is a very aged animal. We have been working with Japan, as you know on beef supplies under 20 months, from animals under 20 months. There is a world of difference between the negotiations with Japan on animals at that age and the fact that this animal was, we have indicated born before the feed ban. So it's at least eight years old.

"The other thing I would offer is that the comments from Japan have been very measured and very much appreciated. Japan as you know has now recorded its 20th case of BSE. Japan has a good understanding of BSE. They also have a good understanding of protecting the food supply.

"Unfortunately Dr. Matthews wasn't able to, we weren't able to get a clear signal, but I'll quote something he said to me as we visited within a half an hour of this news conference. He said something to the effect that finding BSE now is like finding a needle in a haystack. It's just literally becoming difficult to find BSE.

"The reason for that is the ruminant-to-ruminant feed ban, and then when you get into the human health issue it's the removal of the SRMs.

"So very, very clearly I don't think our discussions with Japan will be impacted-- again because we have a huge difference just in the age of the animal.

"Yes.

REPORTER: (off-mike)

SEC. JOHANNS: "The first case was the Washington case, and then this would be the second.

"Yes?

REPORTER: "Mr. Secretary, Dr. Clifford in the Friday teleconference we all remember so well mentioned (unclear) in general about the possibility of atypical case. Is there anything to suggest that would be the case here or is this a case of something kind of sticking out --

SEC. JOHANNS: "Go ahead.

DR. CLIFFORD: "The molecular protein patterns of this particular BSE case were very much like some that have been found in France, not those found typically in the UK. However, there's a lot to be learned about the phenotypic expression of BSE that's unknown. So for the purposes of internationally, this is a case of BSE.

"We would describe this as a case of BSE with a molecular pattern that differs from those that you would see classically from the UK.

SEC. JOHANNS: "Yes, sir?

REPORTER: "Was the cow found (unclear)?

SEC. JOHANNS: "We haven't confirmed where -- it came to a slaughter, a 4D plant in --

DR. CLIFFORD: "It came to a 3D, 4D facility, and that's a facility that would take animals not for human consumption. These are facilities where deads, dyings, diseased or downers would come. And that's all the information we've provided other than the fact that the animal was born prior to the feed ban. It was at least eight-plus years of age, and was a beef animal.

REPORTER: (off-mike)

SEC. JOHANNS: "We're just not going to confirm anything about the animal until we get the epidemiological work done. And I hope you understand we want to be very, very careful about that.

REPORTER: "Why?

SEC. JOHANNS: "Because it's important to everybody. It is. It's an important piece of information, and so we're going to be very, very cautious, and I hope you would understand that.

"Yes?

REPORTER: (inaudible)

SEC. JOHANNS: "This does not change the USDA's position at all referenced to reopening the border with Canada. I continue to believe very, very strongly that the normalization of beef trade worldwide is not only something that the OIE has called for and provided for in terms of its standards, but in our case we are doing everything we can to work with Japan. And again I've said so many times, equal treatment of our trading partners I believe is enormously important. So I don't see that this simply does not change our position relative to reopening the border. We're going to continue to aggressively pursue that litigation to a successful result.

"Yes, sir?

REPORTER: "Can you talk a little bit more about (audio break) especially track down the sibling of the animal, track the food chain?"

DR. CLIFFORD: "Just like the case in Washington state. We would follow the same protocol we did with that particular case. We would like at siblings, cohorts, animals born the same year. Because this is an aged animal, obviously it's less likely you're going to find many of those cohorts in the herd.

"We would also look at offspring within two years of this animal, for the last two years."

REPORTER: "Bill Thomson, Dow Jones. I just want to go back to that last question. You said it wasn't, it didn't appear as the same as cases classically do or normally do in England. But the previous case that we had, the first case, was that the case there? And would this suggest that they were infected in different places or different ways?"

DR. CLIFFORD: "I don't think we can speak to the process of infectivity. It's my understanding the Washington state case, while I haven't discussed this with anyone with regards to molecular banding on the original Washington state, it was my understanding that molecular banding pattern is typical of what you would have found in the cases in the UK."

SEC. JOHANNS: "Yes, ma'am?"

REPORTER: "Mr. Secretary, would you speak a little bit about moving toward (unclear)? First, (unclear) this case when you're hoping to get some more specifics on the breed of the animal, the sex, whether or not it was slaughtered or not. And also, you spoke about the difference between when you came into office and the information in November. Where are you? What safeguards are you hoping to change there?"

SEC. JOHANNS: "A couple of things I would mention. One in reference to your observation about slaughter, again it's very important to emphasize this animal because of our safeguards that the USDA actually put in place before I arrived, this animal did not get anywhere near the human food chain or the feed chain. So there really is no human health risk here.

"What we are pursuing here is I believe a better understanding of what we were dealing with this animal. Where do we go from here? As I mentioned and as we have mentioned in the information that we have put out today, I think there's always an opportunity to improve protocols and improve science. The IHC protocols in place relative to antibodies may make absolute sense two years ago. And they may not make as much sense today. And two years from now the protocols may be different.

"I believe what we have to do to continue to work in this area is to continue to advance that and improve those protocols. How we handle the animals to avoid that confusion of five carcasses literally being there -- and again I emphasize that wasn't a food safety issue because all of the animals were kept out of the food supply -- but again how we treat the samples is a very, very important issue.

"And then there is scientific research going on, and we need protocols in terms of how do you handle these sensitive samples-- very, very important. So from the standpoint of human safety, the safeguards work. These animals never got near the food supply. But I do believe that just in terms of how we handle this there's a real need for improvement.

"Yes."

REPORTER: "(off-mike) -- talk a little bit about if it's so hard to find BSE, should more animals be tested daily?"

SEC. JOHANNS: "Go ahead."

DR. CLIFFORD: "The animal according to the initial report that I received was mentioned in that report as being a downer-- actually heavily soiled with manure."

SEC. JOHANNS: "Then in reference to the question, again using terminology that Dr. Matthews shared this is now getting to a point where it's like looking for a needle in a haystack. BSE because of the ruminant-to-ruminant feed ban is just becoming increasingly rare. We've tested like I said 388,000 animals here, and this is what we come down to.

"Our goal here with the surveillance program is to get a good notion of what the U.S. herd looks like and we're starting to see that picture unfold. What we are going to do is work with the Inspector General to make sure that we're touching the bases we need to touch, that there isn't a part of the country we've overlooked.

"All of those things are things that I want to factor in, but again searching for a needling in a haystack is about where we're at today with BSE. It's just becoming very rare.

"I was at the Ames Laboratory recently, and we're doing some construction of a facility there and I had a long discussion with the scientists about that. They said, You know we're just finding it hard to find cases of BSE. Ruminant-to-ruminant feed ban has made a huge difference worldwide, and that's why you're seeing the decrease worldwide of BSE discovery in animals.

"Yes. Oh, we do have Danny Matthews. I'll take one more question."

DR. CLIFFORD: "He won't be able to hear us. He'll just talk."

SEC. JOHANNS: "He'll just talk. Okay. He won't be able to hear you. He'll talk. I'll go way back there."

REPORTER: (off-mike)

DR. CLIFFORD: "As far as the case of spontaneous, that's a theory. It's one that has not been proven. It may or may not be correct or accurate.

"As far as how much bad feed may be gone out there undetected, we have tested over 388,000 samples from a high-risk population. If there was large numbers of BSE cases in the United States, we would have detected them.

"The IHC test here has been used on three samples. That biorad or rapid screening test detected the sample. The biorad test is widely used internationally and has a high degree of sensitivity."

SEC. JOHANNS: "If I might just address your question, and then I'm going to invite Dr. Matthews to speak.

"We have a body of information today that even a year ago the world didn't possess, Secretary Veneman did not possess, the USDA did not possess. We all agree that our biorad rapid test is working. It's doing exactly what we wanted it to do. There isn't any disagreement on that.

"And here a year later I can stand in front of people and say, this is what we've found. Now, those questions I think were great questions a year ago, but we have irrefutable scientific proof that we've done all these tests and this is really what we've come down to.

"The science very, very clearly is on our side here. There just isn't any doubt about it, and that's what we try to urge people to do is focus on the science, the testing process, the removal of the SRMs, the ruminant-to-ruminant feed ban.

"Those things beyond a shadow of a doubt have made a difference worldwide relative to BSE. And that's why the OIE now recognizes we can trade with each other. We can trade with Japan, we can trade with other countries in the world, and they can trade with us if they have the proper risk mitigation tools in place in what is becoming a really very rare situation when you can even find this disease.

"With that hopefully Dr. Matthews is queued up."

DR. MATTHEWS: "I apologize if anyone has heard some of this earlier, but I touched mostly on the issue of the standardization of IHC methods. There is no single commercially available off-the-shelf IHC method at the moment. I don't think there's any two laboratories for example that use identical methods. Attempts have been made to do so, but even variations in quality of reagents such as water can make a difference in the performance of the tests.

"So we have moved away from trying to standardize the method just to make sure that the outcome is equivalent.

"So what we try to do is issue a panel of reference materials to compare and contrast the performance of the different laboratories to make sure that they can detect all of the positives and they don't come up with any false positives.

"Now as far as the Ames method is concerned, we have been able to confirm the diagnose made at Ames both on new sections that we have cut and stained ourselves but also on one of the sections that was provided to us that was produced by the experimental method.

"I can understand why there was caution in confirming it by using an experimental method at the time, and I'm sure there would have been equal hesitation in this country.

"I can't explain how the standard method at Ames did not detect this particular case at the time. I think it will be necessary to look at the process as a whole. It isn't just an issue of antibodies because essentially this is a bit like baking a cake. You need all of the ingredients blurred together to produce the finished product, and it can be compromised if there is a slight deficiency in one part of the process.

"We've certainly provided our protocols to Ames to look at, and we would look to their information so we can identify what might have gone wrong.

"Now as far as your surveillance is concerned, it's naturally assuring that most if not all of your cattle have been tested using the biorad ELISA. In particular this has been thoroughly road-tested now around the world and possibly the market leader. It has shown itself to be robust and if the biorad ELISA is actually coming up with a positive that can be repeated, then it's actually telling you something significant.

"So in that sense I would agree that reconsidering the spaces of this particular sample has probably enhanced the outcome of your surveillance. Otherwise if you had come to the wider world with data on 400,000 animals that you'd tested but you still had this unresolved in the background, those people who have experience with the biorad ELISA would have challenged that interpretation and possibly accused you of suppressing that information.

"So now you have a positive outcome actually because this piece of information will be very important to your epidemiologists in actually quantifying how much BSE is actually existing in the United States. And I'm pretty confident that it's very little indeed.

"Inevitably just like Europe you are going to have to consider at some point whether you maintain this level of surveillance or you actually reduce the number of samples that you're collecting.

"I think it's important to remember, and it's often forgotten, that this balance is actually done especially for surveillance purposes to define quantify how much BSE if any is actually there. It is not there as a primary consumer protection tool only in the sense that you may detect BSE and thereby enforce new controls. But the primary measure that protects consumers is the SRM rule. The second measure is the feed ban, which hopefully prevents cattle from becoming infected. And then some years down the line we'd make sure those cattle come to the food chain without ever having been exposed.

"So I think one has to eventually realize that testing regimes will have to relax; plus, they are very expensive. It's not just a case of how much the test itself costs. That is only a fraction of the cost. You have to consider the collection, the transportation and disposal arrangements, all of which cost considerably more than the test itself. And at the end of the day one has to wonder how much money one spends on this.

"If we can come to a point where we can learn to live with extremely low risk worldwide from BSE without necessarily having to find every last case that exists in any country, realistically that is simply not possible.

"I think I'd better stop at that point unless there are further questions."

SEC. JOHANNS: "No, I think that's good. All right. Any other questions? I'll get him and then I'll go here."

REPORTER: (off-mike)

SEC. JOHANNS: "It was a beef cow. I think we had mentioned that previously. Again as we get the background information we'll put that out there.

"The other thing I would mention in terms of quarantine again, the firewalls worked. The safeguards that we have in place kept the animal out of the food chain and the animal feed chain.

"And I'll go right next to you."

REPORTER: (off-mike)

SEC. JOHANNS: "I don't believe they were all from the same herd. Or were they?

DR. CLIFFORD: "No, sir. No. All five were not from the same herd. We have a high degree of confidence we know the actual herd, but we need to verify that through DNA testing.

REPORTER: (off-mike)

DR. CLIFFORD: "To my knowledge, no, because we have not verified the index herd, and until we do that --"

SEC. JOHANNS: "Yes."

REPORTER: (off-mike) "-- timetable or timeline for (unclear)?"

SEC. JOHANNS: "Do you have any idea?"

DR. CLIFFORD: "We're trying to do that as expeditiously as possible, and soon as we have that we'll be providing that for the Secretary for release."

SEC. JOHANNS: "If I might address your question about quarantine and this and that, one thought I would offer here, this is a very, very dynamic industry. And we've had our feed ban in place now I believe eight years.

"And animals in the United States move all across the country. They might be born in one state; they might be fed to a certain weight in another state. They might be fed out in another state and slaughtered yet in a fourth state. And that would not be an unusual situation with our beef industry.

"I think some people want to take this notion that there's a herd involved, and that's going to answer all the questions. It doesn't answer. That's not the point here.

"The point here is that after doing 388,000 tests we're just simply getting to the point where as the doctor indicated to me it's a needle-in-a-haystack endeavor. It's just so rare in this country that we run into BSE.

"And that's the value of the information that I possess today as Secretary that did not exist a year ago. I can stand here and say, this is what we found. And I think at the USDA it's been a rather remarkable finding, because when it was kicked off people said, well there's bound to be more found, bound to be more found.

"And they were trying to quantify will it be this many or that many. The reality is, after all this testing we come down to finding one animal through the enhanced surveillance-- because I believe the Washington animal was under the very much smaller amount of surveillance that was being done.

"Any other questions?"

REPORTER: (off-mike)

SEC. JOHANNS: "Oh, I didn't have an emotion like surprise or anything like that. You know, my attitude is, for me this has been an incredible experience to get an understanding of what we're dealing with here. And when I have one of the world's renowned scientists tell me, there is so little risk here and use the terminology like "needle in a haystack," it tends to confirm what I've seen from our testing.

"And his last observation you know that we spend across the world millions and millions and millions of dollars on this and we need to do that if you want to finish the surveillance program as we will, but boy there's a point at which we're just not finding BSE. It's just a rather remarkable phenomena.

"One cow in this enhanced surveillance program so far out of 388,000 of the most high-risk population. Of the most high-risk population."

REPORTER: (off-mike)

SEC. JOHANNS: "Do you know?"

DR. CLIFFORD: "As I've indicated just a few moments ago, we're working as quickly as we can. It requires us to draw samples on animals and run the samples for DNA testing. As soon as we have those results we'll provide them."

SEC. JOHANNS: "Okay. Thank you everybody."


Last Modified: 06/24/2005

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