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MAD COW FEED RECALL OVER 1,000,000 lbs. IN COMMERCE WI ID NV

flounder

Well-known member
Subject: MAD COW FEED RECALL containing blood meal cross contaminated with prohibited MBM OVER 1,000,000 lbs. IN COMMERCE WI, ID, AND NV USA
Date: March 21, 2007 at 2:27 pm PST
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II
___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI

___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007


http://www.fda.gov/bbs/topics/enforce/2007/ENF00996.html




Docket No. 2003N-0312 Animal Feed Safety System [TSS SUBMISSION]

http://www.fda.gov/ohrms/dockets/dockets/03n0312/03N-0312_emc-000001.txt




Docket Management Docket: 02N-0273 - Substances Prohibited From Use in

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be07.html




PART 2


http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012403/8004be09.html




Subject: [Docket No. FSIS-2006-0011] FSIS Harvard Risk Assessment of Bovine
Spongiform Encephalopathy (BSE)


http://www.fsis.usda.gov/OPPDE/Comments/2006-0011/2006-0011-1.pdf




Page 1 of 17 9/13/2005 [PDF]
... Page 1 of 17 From: Terry S. Singeltary Sr. [[email protected]] Sent: Thursday,
September 08, 2005 6:17 PM To: [email protected] Subject ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf




http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf



December 19, 2005



Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane

Room 1061
Rockville, MD 20852


Re: Docket No: 2002N-0273 (formerly Docket No. 02N-0273)


Substances Prohibited From Use in Animal Food and Feed


Dear Sir or Madame:

The McDonalds Corporation buys more beef than any other restaurant in the United States. It is essential for our customers and our company that the beef has the highest level of safety. Concerning BSE, the most effective way to insure this is to create a system that processes cattle that are not exposed to the disease. As a company we take numerous precautions via our strict specifications to help and assure this, however we feel that the force of federal regulation is important to ensure that the risk of exposure in the entire production system is reduced to as close to zero as possible. The exemptions in the current ban as well as in the newly proposed rule make this difficult if not impossible, as there are still legal avenues for ruminants to consume potentially contaminated ruminant protein. In addition, the USDA still has not implemented a system of identification and traceability. It is our opinion that the government can take further action to reduce this risk and appreciate the opportunity to submit comments to this very important proposed rule.

After the identification of bovine spongiform encephalopathy (BSE) in indigenous North American cattle, the U.S. Department of Agriculture (USDA) responded rapidly to implement measures to protect public health in regard to food. Our company recognizes and supports the importance of the current feed ban which went into effect in August 1997. However, given what is known about the epidemiology and characteristically long incubation period of BSE, we urge the FDA to act without further delay and implement additional measures which will reduce the risk of BSE recycling in the US cattle herd. We caution against using the 18 month enhanced surveillance as a justification to relax or impede further actions. While this surveillance indicates an epidemic is not underway, it does not clear the US cattle herd from infection. The positive cases indicate probable exposure prior to the 1997 feed ban, a time when BSE appears to have been circulating in animal feed. BSE cases are most likely clustered in time and location, so while enhanced surveillance provides an 18 month snapshot, it does not negate the fact that US and Canadian cattle were exposed to BSE and that the current feed controls contain “leaks”.


We feel that for the FDA to provide a more comprehensive and protective feed ban, specified risk materials (SRMs) and deadstock must be removed from all animal feed and that legal exemptions which allow ruminant protein to be fed back to ruminants (with the exception of milk) should be discontinued.


SRMs, as defined by the USDA, are tissues which, in a BSE infected animal, are known to either harbor BSE infectivity or to be closely associated with infectivity. If SRMs are not removed, they may introduce BSE infectivity and continue to provide a source of animal feed contamination. Rendering will reduce infectivity but it will not totally eliminate it. This is significant, as research in the United Kingdom has shown that a calf may be infected with BSE by the ingestion of as little as .001 gram of untreated brain.


The current proposed rule falls short of this and would still leave a potential source of infectivity in the system. In fact by the FDA’s own statement the exempted tissues which are known to have infectivity (such as distal ileum, DRGs, etc) would cumulatively amount to approximately 10% of the infectivity in an infected animal. Leaving approximately 10% of the infectious tissues in the system is not good enough. The proposed rule still allows the possibility for cattle to be exposed to BSE through:


Feeding of materials currently subject to legal exemptions from the ban (e.g., poultry litter, plate waste)
Cross feeding (the feeding of non-ruminant rations to ruminants) on farms; and
Cross contamination of ruminant and non-ruminant feed


We are most concerned that the FDA has chosen to include a provision that would allow tissues from deadstock into the feed chain. We do not support the provision to allow the removal of brain and spinal cord from down and deadstock over 30 months of age for several reasons. These are the animals with the highest level of infectivity in tissues which include more than brain and spinal cord. Firstly, there are two issues regarding the complex logistics of this option. We do not feel that it is possible to have adequate removal especially during the warmer months. In addition, we do not feel that there are adequate means to enforce complete removal. Unlike slaughterhouses, there are no government inspectors at rendering plants or deadstock collection points.


Most importantly, there is emerging information that at end stage disease (a natural BSE case); infectivity may also be included in additional tissues such as peripheral nerves (Buschmann and Groschup, 2005 – see attached). This published work supports publicly reported studies in Japan where by western blot testing, prions have been found in the peripheral nerves of a naturally infected 94-month-old cow. If this is the case, the amount of infectivity left in the system from an infected bovine would surpass 10% and the full extent is still unknown.


McDonalds has convened it own International Scientific Advisory Committee (ISAC) as well as co-sponsored a symposium of TSE scientists on the issue of tissue distribution. The consensus of both groups was that the pathogenesis of BSE might not be entirely different from TSEs in other species at the point where the animal is showing signs of the disease. These scientists feel that the studies as reported above have merit. The current studies not only re-enforce the risk of down and deadstock but also appear to provide additional information that these animals may be a potential source of greater levels of infectivity into the feed system. Hence, we suggest that the FDA consult with TSE scientists as well.


Leaving the tissues from the highest risk category of cattle in the animal feed chain will effectively nullify the intent of this regulation. This point is illustrated by the 2001 Harvard risk assessment model that demonstrated that eliminating dead and downer, 4D cattle, from the feed stream was a disproportionately effective means of reducing the risk of re-infection.

“The disposition of cattle that die on the farm would also have a substantial influence on the spread of BSE if the disease were introduced.” The base case scenario showed that the mean total number of ID50s (i.e., dosage sufficient to infect 50 percent of exposed cattle) from healthy animals at slaughter presented to the food/feed system was 1500. The mean total number of ID50s from adult cattle deadstock presented to the feed system was 37,000. This illustrates the risk of “4D cattle” (i.e., deadstock).


From the Harvard Risk Assessment, 2001, Appendix 3A Base Case and Harvard Risk Assessment, 2001 Executive Summary

McDonalds also urges agencies of the US government to work with academia and industry on research in the following areas:

· Methods to inactivate TSEs agents which then may allow a product to be used and even fed to animals without risk

· Alternative uses for animal byproducts which would maintain some value

In July 2004, McDonalds in cooperation with others sponsored a meeting at Penn State. The purpose of the meeting was to review work conducted by Dr. Bruce Miller looking at the feasibility of using carcasses and animal byproducts as renewable alternatives to fossil fuels in large energy generating boilers. A number of government representatives were also invited to this meeting. We are aware that Dr. Miller continues this work which shows great promise. We suggest that the FDA explore the possibility of this alternative use that may also have a positive impact on the environment.

The McDonalds Corporation will continue to work with the FDA and other government agencies to implement a strong BSE risk control program. We would like to reiterate our opinion that for the FDA to provide a more comprehensive and protective feed ban, specified risk materials (SRMs) and deadstock must be removed from all animal feed and that legal exemptions which allow ruminant protein to be fed back to ruminants (with the exception of milk) should be discontinued. Thank you for the opportunity to submit these comments to the public record.


Respectfully,

Dick Crawford

Corporate Vice President, Government Relations


630-623-6754 Direct

630-623-3057 Facsimile

630-841-7968 Mobile

630-963-6068 Residence

[email protected]


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC203.htm




http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC205.htm






PAUL BROWN M.D.


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000490-vol40.pdf





9 December 2005
Division of Dockets Management (RFA-305)

SEROLOGICALS CORPORATION
James J. Kramer, Ph.D.
Vice President, Corporate Operations


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02n-0273-c000383-01-vol35.pdf




Embassy of Japan


http://www.fda.gov/ohrms/dockets/dockets/02n0273/02N-0273-EC240.htm




Dockets Entered on December 22, 2005
2005D-0330, Guidance for Industry and FDA Review Staff on Collection of Platelets
by Automated ... EC 203, McDonald's Restaurants Corporation, Vol #:, 34 ...


http://www.fda.gov/ohrms/dockets/dailys/05/Dec05/122205/122205.htm





03-025IF 03-025IF-631 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-631 Linda A. Detwiler Page 2. Page 3. Page 4.
Page 5. Page 6. Page 7. Page 8. Page 9. Page 10. Page 11. Page 12.


http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-631.pdf




03-025IF 03-025IF-634 Linda A. Detwiler [PDF]
Page 1. 03-025IF 03-025IF-634 Linda A. Detwiler Page 2.
Page 3. Page 4. Page 5. Page 6. Page 7. Page 8.


http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-634.pdf




Page 1 of 17 9/13/2005 [PDF]
... 2005 6:17 PM To: [email protected] Subject: [Docket No. 03-025IFA]
FSIS Prohibition of the Use of Specified Risk Materials for Human Food ...
http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-2.pdf

03-025IFA 03-025IFA-6 Jason Frost [PDF]
... Zealand Embassy COMMENTS ON FEDERAL REGISTER 9 CFR Parts 309 et al [Docket No. 03-
025IF] Prohibition of the Use of Specified Risk Materials for Human Food and ...


http://www.fsis.usda.gov/OPPDE/Comments/03-025IFA/03-025IFA-6.pdf




http://www.fsis.usda.gov/Search/Search_Results/Index.asp?q=03-025IF&mode=simple&num=10&as_occt=any&restrict=FSIS_DOCKET_COMMENTS





In its opinion of 7-8 December 2000 (EC 2000), the SSC ... [PDF]
Page 1. Linda A. Detwiler, DVM 225 Hwy 35 Red Bank, New Jersey 07701 Phone: 732-741-2290
Cell: 732-580-9391 Fax: 732-741-7751 June 22, 2005 FSIS Docket Clerk US ...


http://www.fsis.usda.gov/OPPDE/Comments/03-025IF/03-025IF-589.pdf



THE USDA JUNE 2004 ENHANCED BSE SURVEILLANCE PROGRAM WAS TERRIBLY FLAWED ;


CDC DR. PAUL BROWN TSE EXPERT COMMENTS 2006


The U.S. Department of Agriculture was quick to assure the public earlier
this week that the third case of mad cow disease did not pose a risk to
them, but what federal officials have not acknowledged is that this latest
case indicates the deadly disease has been circulating in U.S. herds for at
least a decade.

The second case, which was detected last year in a Texas cow and which USDA
officials were reluctant to verify, was approximately 12 years old.

These two cases (the latest was detected in an Alabama cow) present a
picture of the disease having been here for 10 years or so, since it is
thought that cows usually contract the disease from contaminated feed they
consume as calves. The concern is that humans can contract a fatal,
incurable, brain-wasting illness from consuming beef products contaminated
with the mad cow pathogen.

"The fact the Texas cow showed up fairly clearly implied the existence of
other undetected cases," Dr. Paul Brown, former medical director of the
National Institutes of Health's Laboratory for Central Nervous System
Studies and an expert on mad cow-like diseases, told United Press
International. "The question was, 'How many?' and we still can't answer
that."

Brown, who is preparing a scientific paper based on the latest two mad cow
cases to estimate the maximum number of infected cows that occurred in the
United States, said he has "absolutely no confidence in USDA tests before
one year ago" because of the agency's reluctance to retest the Texas cow
that initially tested positive.

USDA officials finally retested the cow and confirmed it was infected seven
months later, but only at the insistence of the agency's inspector general.

"Everything they did on the Texas cow makes everything USDA did before 2005
suspect," Brown said. ...snip...end


http://www.upi.com/ConsumerHealthDaily/view.php?StoryID=20060315-055557-1284r



CDC - Bovine Spongiform Encephalopathy and Variant Creutzfeldt ...
Dr. Paul Brown is Senior Research Scientist in the Laboratory of Central
Nervous System ... Address for correspondence: Paul Brown, Building 36, Room
4A-05, ...


http://www.cdc.gov/ncidod/eid/vol7no1/brown.htm


TSS
 

PORKER

Well-known member
The firm does not utilize a code - only shipping documentation with commodity and weights identified.

Not good enough for FDA traceback rules, they needed to have ScoringAg ingredient records traceback on every tag.
 

Bill

Well-known member
Where is all the pissing and moaning from Oldtimer and the other R-Klowns about THIS feed infraction like you bombard us with if there is something happening in Canada? How many US cattle will be quarantined and dealt with like there has been in Canada?

HINT: Not a damn one!
 
A

Anonymous

Guest
Bill said:
Where is all the pissing and moaning from Oldtimer and the other R-Klowns about THIS feed infraction like you bombard us with if there is something happening in Canada? How many US cattle will be quarantined and dealt with like there has been in Canada?

HINT: Not a damn one!

The US hasn't found 5 POST feedban infected cattle either!!
 

Bill

Well-known member
Oldtimer said:
Bill said:
Where is all the pissing and moaning from Oldtimer and the other R-Klowns about THIS feed infraction like you bombard us with if there is something happening in Canada? How many US cattle will be quarantined and dealt with like there has been in Canada?

HINT: Not a damn one!

The US hasn't found 5 POST feedban infected cattle either!!

Ummmmm.........would that be FOUND or forced to announce?

When will Phyllis Fong surface again OVI. Next year, next week, tomorrow?

:oops: :oops: :oops:
 

Manitoba_Rancher

Well-known member
Oldtimer said:
Bill said:
Where is all the pissing and moaning from Oldtimer and the other R-Klowns about THIS feed infraction like you bombard us with if there is something happening in Canada? How many US cattle will be quarantined and dealt with like there has been in Canada?

HINT: Not a damn one!

The US hasn't found 5 POST feedban infected cattle either!!


No you havent found them but some poor consumer has probably eaten them. :roll:
 

Tam

Well-known member
Oldtimer said:
Bill said:
Where is all the pissing and moaning from Oldtimer and the other R-Klowns about THIS feed infraction like you bombard us with if there is something happening in Canada? How many US cattle will be quarantined and dealt with like there has been in Canada?

HINT: Not a damn one!

The US hasn't found 5 POST feedban infected cattle either!!

Let's see according to the OIG based on the USDA's 2004 testing goal of testing 268,500 samples for BSE in 12 to 18 months, the State of Montana was to test 5076 head. From June 1, 2004 until May 31 2005 one year into the new testing Montana tested a whopping 182 head. :shock: Some 4,894 short of their sampling goal. Can we all say SHAME ON YOU OLDTIMER!!!!!! :wink:

South Dakota was to test 6,938, actually tested 2,792 short 4,146
North Dakota was to test 3,616, actually tested 174, short 3,442
Wyoming was to test 2,513, actually tested 61, short 2,452
For a total 14,934 animals short in these four states alone based on the quota of 268,500. But in that time frame the US actually tested over 375,000. According to the OIG Montana's numbers should have gone Up to match their percentage of the number actually tested. But 182 Oldtimer only 182 from the Big State of MONTANA. can we say Shoot Shovel and SHUT UP. :wink:

According to the OIG Texas your largest cattle producing state only tested 50% to 74% of their quota in the first year. Can we all say Shame on Haymaker too!!!!!

Funny how the map looks, three BSE positive cattle found and those three regions The Northwest , South Central and Southeast were the ones that were under the 100% mark on their percentage of samples in the first year of testing. :roll:
 

DiamondSCattleCo

Well-known member
Oldtimer said:
The US hasn't found 5 POST feedban infected cattle either!!

Has the US even tested any post feed ban cattle? Given their track record thus far, its doubtful.

"OH look at the cute lil veal steer. LOOK! It tripped! BSE TEST IT!"

Rod
 
A

Anonymous

Guest
Bitch, Moan, Whine, Cry-- but the Canucks are all scared to go to court against USDA....If you really think USDA screwed up you should have fought for it to go to trial and allowed the evidence of USDA's incompetence to come out -- but wait--- you can't do that- because then the truth about Canada's high risk danger comes out :shock: :wink: :lol: ..
And you can't- because you take the chance of ruining the only market that will take your high risk product-- since Canadian cattlemen now live only on the shirttails of the US cattlemen- selling their beef as US product...

Oh what a tangled web Canucks do weave, since they first began to deceive!! :lol: :lol:

Mantoba Rancher
No you havent found them but some poor consumer has probably eaten them.

What happened to all the Canadian cows marketed between 1993 and 2003 (when Canada stepped up its testing)... :???: Or all those that slipped by the testing since you don't test all...There is no way with the number of positives Canada has that some couldn't have/didn't slip into the food chain in Canada.. :shock: :(

Do you ever wonder how many folks ate them and are walking time bombs out there-- and will show up positive in Canada in the next 10-15 years-- and I guarantee you if someone in the US is connected to a BSE caused disease-- the first thing that happens is that it will be blamed on Canada....

Just like the Japanese- the US population trusts its government for its safety- until they screw up- then they overreact in return..
 

Tam

Well-known member
Oldtimer said:
What happened to all the Canadian cows marketed between 1993 and 2003 (when Canada stepped up its testing)... :???: Or all those that slipped by the testing since you don't test all...There is no way with the number of positives Canada has that some couldn't have/didn't slip into the food chain in Canada.. :shock: :(

Do you ever wonder how many folks ate them and are walking time bombs out there-- and will show up positive in Canada in the next 10-15 years-- and I guarantee you if someone in the US is connected to a BSE caused disease-- the first thing that happens is that it will be blamed on Canada....

Just like the Japanese- the US population trusts its government for its safety- until they screw up- then they overreact in return..


Oldtimer do you really think your vCJD is going to be blamed on Canada, first according to you and Sandhusker US consumers don't know they are eating Canadian beef they think it is all US BEEF due to the USDA INSPECTED LABEL. :wink: and SECOND and most important the media is reporting things like this. :roll: :roll:

Concerns raised about 1997 U.S. mad cow tests
Last Updated: Wednesday, April 13, 2005 | 2:30 PM ET
CBC News
The United States did not properly analyze two suspected cases of mad cow disease in 1997, years before it showed up in Canada and devastated this country's beef industry, a CBC News investigation suggests.
Dr. Masuo Doi, the U.S. Department of Agriculture veterinarian who initially investigated both 1997 cases, says he is haunted by fears that the right tests were not done and that his own department did not properly investigate whether the cow had BSE.
Doi is now retired and speaking for the first time about his concerns.

"I don't want to carry on off to my retirement," he told CBC's Investigative Unit. "I want to hand it over to someone to continue, to find out. I think it's very, very important ...
"How many did we miss?"
Doi's concerns are echoed by Dr. Karl Langheindrich, the chief scientist at a U.S. Department of Agriculture lab in Athens, Ga., that ran the early tests on one of the cows.
Documents obtained by CBC show that the samples tested by the department did not contain parts of the animal's brain critical for an accurate diagnosis.
Langheindrich told CBC that the department will never be able to say for sure what was wrong with the cow, though at the time it publicly ruled out bovine spongiform encephalopathy.
"Based on the clinical symptoms and the description given by the veterinarian, you can verify, yes, this animal had CNS, central nervous system disease, but you can't specify it in your findings further than that," he said.

The U.S. Department of Agriculture is refusing to talk about the cases, saying the documents provided to CBC speak for themselves.
1997 video from New York shows stricken cow
The scientists' comments raise new questions about how the U.S. industry has been able to essentially escape BSE when Canada's much smaller industry, observing almost identical safety and testing practices, has had four cases in the past two years.
Part of the answer could be in a slaughterhouse in Oriskany Falls, N.Y., which eight years ago may have become the home of the first American case of mad cow.
Bobby Godfrey, who worked at the plant, remembers a cow that arrived one day in May 1997.
"I thought it was a mad dog, to tell you the truth," he told CBC. "Didn't know what the hell it was. Never seen a cow act like that in all the cows I saw go through there. There was definitely something wrong with it."
The suspect cow was recorded on USDA videotape, which has been obtained by CBC News. It shows the animal trembling, hunching its back and charging plant workers.
"Me and my vet, including our inspector, they thought [the cow] was quite different," Doi told CBC. "They thought it was the BSE."
Key areas of brain not tested: documents
Documents obtained by CBC News show that the U.S. government was preparing for the worst. Initial signs pointed to its first case of mad cow disease, which would have immediate impacts on U.S. beef exports to countries around the world.
But further tests on the animal came back negative, the USDA later reported.
The final conclusion from an independent university lab: The cow had a rare brain disorder never reported in that breed of cattle either before or since – not the dreaded bovine spongiform encephalopathy.
CBC News has now learned that key areas of the brain where signs of BSE would be most noticeable were never tested. The most important samples somehow went missing.
That information was contained in a USDA lab report that was left out of the documents officially released by the department. It proves that the scientist in charge of the case knew his investigation was limited because of the missing brain tissue.
Second suspected case surfaces at same plant
With questions about the first cow still lingering, a second American cow showed up at the same plant three months later with suspicious symptoms. Videotape of that animal shows its head was bobbing and it was unable to rise to its feet, setting off warning bells for mad cow disease.
The second cow's brain was also sent for testing. Officials were later told verbally that the samples had tested negative for BSE.
Doi made repeated requests for documentary proof of the negative tests. To this day, he has seen nothing.
"How many are buried?" he wonders of other possible cases of BSE in the United States. "Can you really trust our inspection [system]?"
For weeks, the USDA told CBC that it had no records for the second cow suspected of having BSE in 1997. Then just a few days ago, it suddenly produced documents that it says proves that a cow was tested and that the tests were negative for mad cow disease.
But the documents also prove, once again, that there were problems with the testing. This time, so much brain tissue was missing that it compromised the examination.
The problems were so severe that one USDA scientist wrote that his own examination was of "questionable validity" because he couldn't tell what part of the cow's brain he was looking at.
Felicia Nestor, a lawyer who represents U.S. government whistle-blowers, says she isn't surprised by what this CBC News investigation uncovered.
"There have been too many times where information or tissues or other evidence has just sort of disappeared, fallen through the cracks," said Nestor, who has been handling USDA-related cases for nearly 10 years.
"There are a lot of holes. There are a lot of holes."

Commons committee hears coverup allegations
The results of the CBC investigation were broadcast on the same day that a former U.S. agriculture inspector, during testimony at a House of Commons committee, accused his own government of covering up suspected cases of BSE.
On Tuesday, Lester Friedlander repeated a claim he has made before – that cases of BSE surfaced in the U.S. long before the disease showed up in Canada.
Friedlander, who was fired from his job as head of inspections at a meat-packing plant in Philadelphia in 1995 after criticizing what he called unsafe practices, says he is willing to take a lie detector test to prove he is telling the truth.
The U.S. government has denied his allegations.
Then add to this report, the fact that the OIG investigated the US system after BSE was found and found the testing you do was faulty. Remember the change in testing protocol after PHYLLIS FOUND the Texas cow. I doubt we are going to be blamed for your BSE problem since Phyllis proved you have it too.

BTW Oldtimer why is Montana only testing a FRACTION of their state quota? less than 5 percent if the OIG was right. 182 out of 5076, shame on you, are you scared of what you will find if Montana actually tests their fair share? :shock:
 
A

Anonymous

Guest
TAM
BTW Oldtimer why is Montana only testing a FRACTION of their state quota? less than 5 percent if the OIG was right. 182 out of 5076, shame on you, are you scared of what you will find if Montana actually tests their fair share?

TAMMY- Good operators don't keep their cows around until they are old/ ancient/crippled and die on the farm...Most around here have a program where they go at age 10-12- when they are worth something for cull value.....Many of the cattle that die around here are never found or found as just bones and hide (if the coyote don't eat the hide)...
I know we never had any die during their testing period- and I doubt if many did (that they were aware of right away)...

Tam- Did you send a letter of opposition in to the CFIA to keep out US cattle/beef? If you have such a problem with our testing program you shouldn't be taking our beef/cattle-- except that could shake up your little gravy train ride on the shirttails of the US cattle industry-eh :wink: :lol:

You whine and moan about the USDA, and the entire US BSE policy, and the US (Montana) cattlemen- except when the USDA's border rule is questioned by US cattlemen and R-CALF, you unwaiveringly support and praise the USDA and their decision making skills-- and cuss the US groups for questioning their competency and motives.... :roll:

And Tam- when/if vCJD appears- I guarantee you every consumer in the country will be made aware of the fraud that has passed off higher risk Canadian beef as US product-- and every politician- bureaucrat- muckymuck in the country will be scrambling to CYA- and point fingers-- and Canada will be the one that is used to do that with, because the extent of the disease up there has been so publicized .....

You don't have to believe me- but just wait until it happens...All Canadians think that getting the Border reopened and back on the status quo of riding the US cattlemans shirttails will be the end of their Mad Cow problems-- but I don't think they've come close to seeing what they will see if/when vCJD is found and/or if BSE is tied to some of the other dementia diseases like it appears it could be.....
 

Tam

Well-known member
Oldtimer said:
TAM
BTW Oldtimer why is Montana only testing a FRACTION of their state quota? less than 5 percent if the OIG was right. 182 out of 5076, shame on you, are you scared of what you will find if Montana actually tests their fair share?

TAMMY- Good operators don't keep their cows around until they are old/ ancient/crippled and die on the farm...Most around here have a program where they go at age 10-12- when they are worth something for cull value.....Many of the cattle that die around here are never found or found as just bones and hide (if the coyote don't eat the hide)...
I know we never had any die during their testing period- and I doubt if many did (that they were aware of right away)....

GEE The USDA estimated the High risk cattle in the US to number about 446,000 in 2004, but the OIG estimated there was a million high risk cattle in the US, according to their Audit findings. High risk are those described as old/crippled, dieing in farm those recommended by the OIE for testing . Where are all these high risk cattle Oldtimer in Rhode Island? :roll:
 
A

Anonymous

Guest
Tam--Ever time a Canuck gets smug and hoity toity about their testing I remember that their socialist government had to pay them to get them to test- in some provinces more than the live cattle were worth.... :roll:

So its not surprising the number tested, as historically its been shown Canucks will do anything for an extra buck- like selling out their industry(s) to foreign interests and supporting lying, fraud, and deception to sell their product. :wink:
 

Kato

Well-known member
Good Grief! :shock: :shock: :shock: :shock: :shock: Now that's just plain rude.

What's an extra buck? The one that buys the groceries? Or the one that pays this month's interest on all the new loans we're living with?

Yup, we're willing to do anything for an extra buck, like try and survive.........

BTW. If you think $75.00 is an extravagent amount to pay for a BSE sample on a farm, then come to Manitoba and become a millionaire like everyone here. :roll: :roll: :roll: :roll: :roll:

As for selling out, I won't even get into the old Yankee Imperialism cliche........
 

flounder

Well-known member
Tam said:
snip...

Then add to this report, the fact that the OIG investigated the US system after BSE was found and found the testing you do was faulty. Remember the change in testing protocol after PHYLLIS FOUND the Texas cow. I doubt we are going to be blamed for your BSE problem since Phyllis proved you have it too.

quote]


hi tam,


don't forget the other mad cow they let slip away, the other tissue samples they let sit up on a shelf, not the usual 7 months before testing, but this tissue sample of a potential mad cow sat on a shelf for 4 months ;



USDA BSE inconclusive MRR policy


BESIDES THE TEXAS MAD COW THAT WAS RENDERED AND NEVER TESTED;


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. ...


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



BESIDES the Texas mad cow that sat on the shelf for 7+ months before the Honorable Phyllis Fong of the OIG finally did the end around Johanns et al and finally had Weybridge bring that negative cow back from the dead to finally being a confirmed mad cow (hint, hint, getting MRR implemented first), was this simply another bumbling of BSE protocol, or just same old same old;


Jim Rogers (202) 690-4755

USDA Press Office (202) 720-4623

Statement by Chief Veterinary Medical Officer John Clifford Animal and Plant Health Inspection Service Regarding Non-Definitive BSE Test Results
July 27, 2005


snip...

Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing. As we have previously experienced, it is possible for an IHC test to yield differing results depending on the “slice” of tissue that is tested. Therefore, scientists at our laboratory and at Weybridge will run the IHC test on additional “slices” of tissue from this animal to determine whether or not it was infected with BSE. We will announce results as soon as they are compiled, which we expect to occur by next week.

I would note that the sample was taken in April, at which time the protocols allowed for a preservative to be used (protocols changed in June 2005). The sample was not submitted to us until last week, because the veterinarian set aside the sample after preserving it and simply forgot to send it in. On that point, I would like to emphasize that while that time lag is not optimal, it has no implications in terms of the risk to human health. The carcass of this animal was destroyed, therefore there is absolutely no risk to human or animal health from this animal.


snip...


http://www.aphis.usda.gov/lpa/news/2005/07/bsestatement_vs.html


"The sample was submitted to us by a private veterinarian. As an extension of our enhanced surveillance program, accredited private veterinarians who often visit farms in remote areas collect samples when warranted. The sample in question today was taken from a cow that was at least 12 years of age and experienced complications during calving.

"The veterinarian treated the sample with a preservative which readies it for testing using the immunohistochemistry test, an internationally recognized confirmatory test for BSE.

"Neither the rapid screening test nor the Western blot confirmatory test can be conducted on a sample that has been preserved. Our laboratory ran the IHC test on the sample and received non-definitive results that suggest the need for further testing.

"As we have previously experienced, it is possible for an IHC test to yield differing results, depending on the slice of tissue that is tested. Therefore scientists at our laboratory and at Weybridge will run the IHC test on additional slices of tissue from this animal to determine whether or not it was infected with BSE.

"We will announce results as soon as they are compiled, which we expect to occur by next week.


snip...


http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml



NOW, all the above announced July 27, 2005. SO, the other 'inconclusive' sample has been sitting on the shelf since April, some 4 months earlier, give or take a few days. NOW, what has been going on while this other inconclusive BSE/BASE mad cow sits on the shelf. Lets look at that BSE MRR COMMODITY time frame ;-)


7/20/05 USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Farm Raised Cervids from Canada PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Camelids from Canada PDF


7/15/05 Importation of Bovines (Cattle or Bison) from Canada for Feeding PDF BSE Minimal-Risk Regions and the Importation of Live Animals Importers, Brokers, and Other Interested Parties PDF BSE Minimal-Risk Regions and the Importation of Live Animals Accredited Veterinarians or Other Interested Parties PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for The Importation of Cattle or Bison for Feeding from Canada PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Cattle, Bison, Sheep and Goats for Immediate Slaughter from Canada PDF USDA, APHIS, Veterinary Services, National Center for Import and Export: Protocol for the Importation of Sheep and Goats for Feeding from Canada PDF Animal Products Implementation: Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities from Canada PDF Johanns Announces Next Steps for Importing Canadian Cattle Transcript of Tele-News Conference with Agriculture Secretary Mike Johanns Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities— FINAL RULE— 9 CFR Parts 93, 94, 95, and 96 [Docket No. 03-080-3] Bovine Spongiform Encephalopathy; Minimal-Risk Regions and Importation of Commodities; Partial Delay of Applicability [Docket No. 03-080-6] — Final rule; partial delay of applicability — 9 CFR Parts 94 and 95
Published March 11, 2005 — 70 FR 12112-12113 Text | PDF • Risk Document PDF • Economic Analysis PDF • Appendices to economic analysis PDF • Final environmental assessment PDF • Final Rule on BSE and Minimal-Risk Regions (Factsheet) • Questions and Answers for Minimal Risk/Canada Rule • Port of Entry for Eligible Ruminants 7/14/05 Secretary Johanns Statement on Ninth Circuit Court Ruling


04/01/05 Canada, Mexico And United States Release Harmonized North American BSE Strategy Harmonization of a BSE Strategy (PDF)


03/17/05 U.S. Government Requests Appeal In Minimal-Risk Rule Case


03/04/05 BSE Minimal-Risk Regions and Importation of Live Animals and Commodities From Canada Delay of Effective Date (Memo)


03/03/05 Statement By Agriculture Secretary Mike Johanns Regarding The Temporary Injunction Issued By The U.S. District Court For The District Of Montana Regarding USDA's Minimal-Risk Rule



KEEP THEM DOGGIES ROLLING, RAWHIDE, ye ha !


NOT to forget ;


It should be noted that since the enhanced surveillance program began, USDA has also conducted approximately 9,200 routine IHC tests on samples that did not first undergo rapid testing. This was done to ensure that samples inappropriate for the rapid screen test were still tested, and also to monitor and improve upon IHC testing protocols. Of those 9,200 routine tests, one test returned a non-definitive result on July 27, 2005. That sample underwent additional testing at NVSL, as well as at the Veterinary Laboratories Agency in Weybridge, England, and results were negative. ......


http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html


r i g h t ............


sounds like a recording ;


Subject: REPORT OF THE COMMITTEE ON SCRAPIE November 9, 2005 USAHA
Date: February 12, 2006 at 1:03 pm PST

REPORT OF THE COMMITTEE ON SCRAPIE

Chair: Dr. Jim Logan, Cheyenne, WY

Vice Chair: Dr. Joe D. Ross, Sonora, TX

Dr. Deborah L. Brennan, MS; Dr. Beth Carlson, ND; Dr. John R. Clifford, DC; Dr. Thomas F. Conner, OH; Dr. Walter E. Cook, WY; Dr. Wayne E. Cunningham, CO; Dr. Jerry W. Diemer, TX; Dr. Anita J. Edmondson, CA; Dr. Dee Ellis, TX; Dr. Lisa A. Ferguson, MD; Dr. Keith R. Forbes, NY; Dr. R. David Glauer, OH; Dr. James R. Grady, CO; Dr. William L. Hartmann, MN; Dr. Carolyn Inch, CAN; Dr. Susan J. Keller, ND; Dr. Allen M. Knowles, TN; Dr. Thomas F. Linfield, MT; Dr. Michael R. Marshall, UT; Dr. Cheryl A. Miller, In; Dr. Brian V. Noland, CO; Dr. Charles Palmer, CA; Dr. Kristine R. Petrini, MN; Mr. Stan Potratz, IA; Mr. Paul E. Rodgers, CO; Dr. Joan D. Rowe, CA; Dr. Pamela L. Smith, IA; Dr. Diane L. Sutton, MD; Dr. Lynn Anne Tesar, SD; Dr. Delwin D. Wilmot, NE; Dr. Nora E. Wineland, CO; Dr. Cindy B. Wolf, MN.

The Committee met on November 9, 2005, from 8:00am until 11:55am, Hershey Lodge and Convention Center, Hershey, Pennsylvania. The meeting was called to order by Dr. Jim Logan, chair, with vice chairman Dr. Joe D. Ross attending. There were 74 people in attendance.

The Scrapie Program Update was provided by Dr. Diane Sutton, National Scrapie Program Coordinator, United States Department of Agriculture (USDA), Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS). The complete text of the Status Report is included in these Proceedings.

Dr. Patricia Meinhardt, USDA-APHIS-VS-National Veterinary Services Laboratory (NVSL) gave the Update on Genotyping Labs and Discrepancies in Results. NVSL conducts investigations into discrepancies on genotype testing results associated with the Scrapie Eradication Program. It is the policy of the Program to conduct a second genotype test at a second laboratory on certain individual animals. Occasionally, there are discrepancies in those results. The NVSL conducts follow-up on these situations through additional testing on additional samples from the field and archive samples from the testing laboratories.

For the period of time from January 1, 2005, until October 15, 2005, there were 23 instances of discrepancies in results from 35 flocks. Of those 23 instances, 14 were caused by laboratory error (paperwork or sample mix-up), 3 results from field error, 5 were not completely resolved, and 1 originated from the use of a non-approved laboratory for the first test. As a result of inconsistencies, one laboratory’s certification was revoked by APHIS-VS.

To reduce/eliminate these problems, the Program has placed additional quality requirements on the testing laboratories: additional review of final reports, additional coding systems for testing operations, strict follow-up and reports to NVSL on corrective actions, dual data entry systems, and more frequent inspections. ........


snip...


http://www.usaha.org/committees/reports/2005/report-scr-2005.pdf





USDA Testing Protocols and Quality Assurance Procedures

In November 2004, USDA announced that its rapid screening test produced an inconclusive BSE test result. A contract laboratory ran its rapid screening test on a brain sample collected for testing and produced three high positive reactive results. As required, the contract laboratory forwarded the inconclusive sample to APHIS’ National Veterinary Services Laboratories (NVSL) for confirmation. NVSL repeated the rapid screening test, which again produced three high positive reactive results. Following established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE.

Faced with conflicting results between the rapid screening and IHC tests, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded that no further testing was necessary since testing protocols were followed and the confirmatory test was negative. In our discussions with APHIS officials, they justified their decision to not do additional testing because the IHC test is internationally recognized as the "gold standard" of testing. Also, they believed that

USDA/OIG-A/50601-10-KC/ Page iv

conducting additional tests would undermine confidence in USDA’s testing protocols.

OIG obtained evidence that indicated additional testing was prudent. We came to this conclusion because the rapid screening tests produced six high positive reactive results, the IHC tests conflicted, and various standard operating procedures were not followed. Also, our review of the relevant scientific literature, other countries’ protocols, and discussions with experts led us to conclude that additional confirmatory testing should be considered in the event of conflicting test results.

To maintain objectivity and independence, we requested that USDA’s Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) immunoblot test. The additional testing produced positive results. To confirm, the Secretary of Agriculture requested that an internationally recognized BSE laboratory in Weybridge, England (Weybridge) perform additional testing. Weybridge conducted various tests, including their own IHC tests and three Western blot tests. The tests confirmed that the cow was infected with BSE. The Secretary immediately directed USDA scientists to work with international experts to develop new protocols that include performing dual confirmatory tests in the event of an inconclusive BSE screening test.

We attribute the failure to identify the BSE positive sample to rigid protocols, as well as the lack of adequate quality assurance controls over its testing program. Details of our concerns are discussed in Findings 3 and 4.


snip...


Section 2. Testing Protocols and Quality Assurance Controls In November 2004, USDA announced that its rapid screening test, Bio-Rad Enzyme Linked Immunosorbent Assay (ELISA), produced an inconclusive BSE test result as part of its enhanced BSE surveillance program. The ELISA rapid screening test performed at a BSE contract laboratory produced three high positive reactive results.40 As required,41 the contract laboratory forwarded the inconclusive sample to the APHIS National Veterinary Services Laboratories (NVSL) for confirmatory testing. NVSL repeated the ELISA testing and again produced three high positive reactive results.42 In accordance with its established protocol, NVSL ran its confirmatory test, an immunohistochemistry (IHC) test, which was interpreted as negative for BSE. In addition, NVSL performed a histological43 examination of the tissue and did not detect lesions44 consistent with BSE. Faced with conflicting results, NVSL scientists recommended additional testing to resolve the discrepancy but APHIS headquarters officials concluded no further testing was necessary because testing protocols were followed. In our discussions with APHIS officials, they justified their decision not to do additional testing because the IHC is internationally recognized as the “gold standard.” Also, they believed that conducting additional tests would undermine confidence in USDA’s established testing protocols. However, OIG obtained evidence that indicated additional testing was prudent to ensure that USDA’s testing protocols were effective in detecting BSE and that confidence in USDA’s testing procedures was maintained. OIG came to this conclusion because the rapid tests produced six high positive reactive results, confirmatory testing conflicted with the rapid test results, and various standard operating procedures were not followed. Also, our review of scientific literature, other country protocols, as well as discussions with internationally recognized experts led us to conclude that confirmatory testing should not be limited when conflicting test results are obtained. To maintain objectivity and independence in our assessment, we requested the USDA Agricultural Research Service (ARS) perform the Office International des Epizooties (OIE) Scrapie-Associated Fibrils (SAF) 40 ELISA test procedures require two additional (duplicate) tests if the initial test is reactive, before final interpretation. If either of the duplicate tests is reactive, the test is deemed inconclusive. 41 Protocol for BSE Contract Laboratories to Receive and Test Bovine Brain Samples and Report Results for BSE Surveillance Standard Operating Procedure (SOP), dated October 26, 2004. 42 The NVSL conducted an ELISA test on the original material tested at the contract laboratory and on two new cuts from the sample tissue. 43 A visual examination of brain tissue by a microscope. 44 A localized pathological change in a bodily organ or tissue.

immunoblot.45 ARS performed the test at the National Animal Disease Center because NVSL did not have the necessary equipment46 (ultracentrifuge) to do the test. APHIS scientists observed and participated, as appropriate, in this effort. The additional tests conducted by ARS produced positive results. To confirm this finding, the Secretary requested the internationally recognized BSE reference laboratory in Weybridge, England, (Weybridge) to perform additional confirmatory testing. Weybridge conducted various tests, including their own IHC methods, as well as three Western blot methods. The tests confirmed that the suspect cow was infected with BSE. Also, Weybridge confirmed this case as an unequivocal positive case of BSE on the basis of IHC. As a result of this finding, the Secretary immediately directed USDA scientists to work with international experts to develop a new protocol that includes performing dual confirmatory tests in the event of another inconclusive BSE screening test. Finding 3 Rigid Protocols Reduced the Likelihood BSE Could be Detected APHIS relied on a single test method, as well as a histological examination of tissue for lesions consistent with BSE, to confirm the presence of BSE even though discrepant test results indicated further testing may be prudent. When IHC test results were interpreted as negative, APHIS concluded the sample tested negative for BSE. Subsequent independent tests initiated by OIG using a different testing method, as well as confirmatory testing by Weybridge, determined that the suspect sample was a positive case of BSE. APHIS Declares BSE Sample Negative Despite Conflicting Results When the tissue sample originally arrived at NVSL in November 2004 from the contract lab, NVSL scientists repeated the ELISA screening test and again produced three high positive reactive results. NVSL scientists cut out two sections of the brain sample for IHC testing. One section was used for an experimental procedure that was not part of the confirmatory testing protocol, and the other cut was for normal IHC testing using scrapie for a positive control.47 According to NVSL scientists, the experimental test results were inconclusive but the IHC test was interpreted as negative. The NVSL scientists were concerned with the inconsistencies and conducted 45 The OIE SAF immunoblot is an internationally recognized confirmatory test, often referred to as a Western blot test. There are different types of Western blots; the OIE SAF immunoblot includes enrichment steps taken with the sample prior to the standard Western blot steps. 46 APHIS has now ordered the necessary equipment for NVSL. USDA/OIG-A/50601-10-KC Page 32

47 A positive control is a sample that is known to contain a given disease or react in the test. The sample then can be used to make sure that the test for that disease works properly. In the case of BSE, tissue infected with either scrapie or BSE can serve as a positive control for an IHC test for BSE since both are different forms of the same disease (transmissible spongiform encephalopathy or TSE).

another IHC test using BSE as a positive control.48 The test result was also interpreted as negative. Also, according to the NVSL scientists, the histological examination of the tissue did not detect lesions consistent with BSE. After the second negative IHC test, NVSL scientists supported doing additional testing. They prepared a plan for additional tests; if those tests had been conducted, BSE may have been detected in the sample. The additional tests recommended by NVSL scientists, but not approved by APHIS Headquarters officials, were the IHC using other antibodies (IHC testing using different antibodies ultimately produced positive results); IHC testing of additional regions of the brain (the cerebellum tested positive); regular and enriched (OIE-like) Western blots (the obex and cerebellum tested positive); and variable rapid tests (the obex and cerebellum tested positive with two different rapid tests). NVSL officials also recommended that the sample be sent to Weybridge for confirmatory testing (to conduct IHC and OIE Western blot tests). In June 2005, Weybridge conducted IHC testing with three different antibodies, including the antibody used in the United States (tested positive), the OIE Western blot (tested positive), a modified commercial kit Western blot (negative) and the NaPTA49 Western blot (tested positive). We obtained information as to the differing protocols used by other countries. We found that while APHIS determined that additional testing was unnecessary after the IHC test, other countries have used multiple tests to confirm positives. In Japan, for example, all reactive screening test samples are examined by both IHC and a Western blot (different from the OIE SAF immunoblot). In the United Kingdom (U.K.), IHC and Western blot (different from the OIE SAF immunoblot) tests are used for all animals that test positive with a screening test. When IHC and the Western blot fail to confirm a positive rapid test, the U.K. resorts to a third test, the OIE SAF immunoblot. With these procedures in place, both Japan and the U.K. have found BSE cases that were rapid test reactive, IHC negative, and finally confirmed positive with a Western blot. Evidence Indicated Additional Testing Would Be Prudent We also spoke with an internationally recognized BSE expert regarding the advisability of limiting confirmatory testing when conflicting results are obtained. This official expressed concern about limiting confirmatory tests to the IHC despite its status as one of the “gold standard” tests. He advised that the IHC is not one test; it is a test method that can vary significantly in sensitivity from laboratory to laboratory. New antibodies can improve or

USDA/OIG-A/50601-10-KC Page 33

48 The NVSL uses scrapie as the positive control as part of its normal IHC testing procedures. Due to the conflicting results between the ELISA and IHC tests, the NVSL conducted another IHC test with BSE as the positive control. Subsequently, the NVSL modified the Confirming Inconclusive Results from BSE Testing Laboratories at the NVSL SOP to show that all IHC tested BSE inconclusive samples from contract laboratories will use BSE as the positive control. 49 Sodium phosphotungstic acid.

USDA/OIG-A/50601-10-KC Page 34

reduce sensitivity, as can variations in many of the reagents50 used. He explained that his laboratory had experienced cases where an initial confirmatory IHC test was challenged by either a more extensive IHC test or “…applying a more sensitive immunoblot.” He emphasized the importance of having additional confirmatory testing to resolve discrepant results since there are many variables, and most of the variability appears to be due to test performance of the laboratory. OIG became concerned that APHIS relied on its confirmatory test methods when rapid screening tests produced high positive reactive results six times.51 Also, we found that APHIS did not pursue and/or investigate why the ELISA produced high reactive positives. An official from the manufacturer of the ELISA test kit told us that they requested, but did not receive, information on the inconclusive reported by USDA in November 2004. These officials requested this information in order to understand the reasons for the discrepant results. The Bio-Rad ELISA rapid screening test is internationally recognized as a highly reliable test and is the rapid screening test used for USDA’s surveillance effort. According to APHIS officials, they felt it would be inappropriate to collaborate on the one sample because Bio-Rad is a USDA-APHIS regulated biologics company and only one of several competing manufacturers. To maintain confidence in USDA’s test protocols, it would have been a prudent course of action for USDA to determine why such significant differing results were obtained. The fact that they did not pursue this matter caused concerns relating to testing quality assurance procedures. In this regard, we found lack of compliance with SOPs relating to laboratory proficiency and quality assurance (see Finding 4), and, in this case, the storage of sampled material and reporting of test results. We found that the NVSL did not prepare a report to document its confirmatory testing of the November 2004 sample. The SOP52 states that the BSE network laboratory initiating the inconclusive will receive a report of the case. NVSL officials could not explain why a final report had not been prepared. We also found that the inconclusive sample was frozen prior to IHC confirmatory testing. APHIS protocols state that samples are not to be frozen prior to laboratory submission. The OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals states that the tissues for histological or IHC examination are not to be frozen as this will provide artefactual53 lesions that may compromise the identification of vacuolation,54 and/or target site location. Although the sample was frozen, APHIS did not conduct a Western 50 A substance used in a chemical reaction to detect, measure, examine, or produce other substances. 51 The six high positive reactive results were from three tests of the submitted sample (multiple runs of the same test). 52 Confirming Inconclusive Results from Bovine Spongiform Encephalopathy Testing Laboratories at the NVSL SOP, dated August 13, 2004. 53 A structure or feature not normally present but visible as a result of an external agent or action, such as one seen in a microscopic specimen after fixation. 54 A small space or cavity in a tissue.

USDA/OIG-A/50601-10-KC Page 35

blot test on the sample. An NVSL official said freezing the sample does not make it unsuitable for IHC. APHIS determined that the sample was suitable for IHC and therefore, in accordance with its SOP, did not conduct a Western blot test. APHIS also handled the December 2003 BSE positive differently than the November 2004 sample. For the December 2003 BSE positive sample, APHIS conducted several confirmatory tests in addition to the IHC testing and histological examination (unlike the November 2004 sample tests, both of these were interpreted as positive). ARS performed two Western blots (Prionics Check Western blot and an ARS developed Western blot). When we questioned why the samples were handled differently, APHIS officials stated that the Western blots were done because the IHC in December 2003 was positive. The additional testing was done to further characterize the case, because it was the first U.S. case; the additional testing was not done to decide whether the case was positive or negative. We discussed our concerns with limiting confirmatory testing, particularly given conflicting results, with the APHIS Administrator and staff in May 2005. He explained that international standards recognized more than one “gold standard” test. In setting up its testing protocols, USDA had chosen one as the confirming test, the IHC test, and stayed with it. APHIS protocols only allow a Western blot in cases where the sample has become unsuitable for IHC tests (e.g., in cases where the brainstem architecture is not evident). International standards, he continued, accept a tissue sample as negative for BSE if its IHC test is negative. Once the test is run in accordance with protocols, additional tests undermine the USDA testing protocol and the surveillance program. He concluded that since APHIS’ protocols accepted the IHC test as confirming the presence or absence of BSE, no further testing was necessary. According to protocol, the tissue sample was determined to have tested negative for BSE. On June 24, 2005, USDA announced that the additional testing by the BSE reference laboratory in England confirmed the presence of BSE in the tissue sample. To obviate the possibility that a future sample would be declared negative and then found positive, the Secretary of Agriculture announced a change to APHIS’ testing protocols that same day. He called for “dual confirmatory tests in the event of another ‘inconclusive’ [reactive] BSE screening test.” He also indicated that he would reinforce proper procedures so that samples will not be frozen, and to spot-check the laboratories to see that they complete reports as required. APHIS issued a SOP on the new confirmatory testing protocols on November 30, 2005.


http://www.usda.gov/oig/webdocs/50601-10-KC.pdf


USDA ANNOUNCES BSE TEST RESULTS AND NEW BSE CONFIRMATORY TESTING PROTOCOL

WASHINGTON, June 24, 2005 -- Agriculture Secretary Mike Johanns today announced that the U.S. Department of Agriculture has received final test results from The Veterinary Laboratories Agency in Weybridge, England, confirming that a sample from an animal that was blocked from the food supply in November 2004 has tested positive for bovine spongiform encephalopathy (BSE). Johanns also directed USDA scientists to work with international experts to thoughtfully develop a new protocol that includes performing dual confirmatory tests in the event of another "inconclusive" BSE screening test.


http://www.usda.gov/wps/portal/


HOWEVER, when Dr. Detwiler tried to tell them this in 2003, they shot the messenger ;


BACK IN TIME ;


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


2005

=============================


AFTER this administration put Dr. Detwiler out to pasture cause she did not agree with there BSE protocols, she was so wrong, she now works to make sure our beef at McDonald's is safe cause McDonalds saw the writing on the wall ;



International Scientific Advisory Council
McDonald's International Scientific Advisory Council adds further strength to our beef safety program by providing independent expert scientific and medical advice on bovine spongiform encephalopathy (BSE).

COUNCIL MEMBERS

Dr. Neil Cashman. Diener Professor of Neurodegenerative Diseases and Director, Neuromuscular Disease Clinic, Sunnybrook & Women's Health Sciences Center, University of Toronto. Specialist in motor neuron diseases and the cell biology of amyloid encephalopathies, including prion illnesses. Author of over 250 publications. Recipient of the 2000 Jonas Salk Prize for biomedical research.

Dr. Dean Danilson. Vice President QAFS, Tyson Foods, Inc. Responsible for quality assurance and food safety programs for the retail division for fresh beef, pork, poultry and ready-to-eat meats.

Dr. Linda Detwiler. Adjunct Professor, Virginia-Maryland Regional College of Veterinary Medicine, University of Maryland. Also provides private animal health consulting services, with specializations in transmissible spongiform encephalopathies, emergency preparedness, and animal product issues related to imports and exports. Formerly Senior Staff Veterinarian, Emergency Programs Staff, U.S. Department of Agriculture Animal and Plant Health Inspection Service, the unit principally responsible for surveillance, prevention, and education activities related to BSE. Member of various international working groups and advisory committees on TSEs. Author of numerous articles on the issues.

Alan A. Harris, M.D. Professor of Internal Medicine and Preventive Medicine, Senior Assistant Chairman, Department of Internal Medicine, Hospital Epidemiologist, Rush-Presbyterian-St. Luke's Medical Center. Specialist in public health and foodborne illnesses. Fellow, Infectious Diseases Society of America. Fellow, American College of Physicians. Member, Society of Healthcare Epidemiology of America. Author or co-author of more than 140 scientific publications.

Dr. Beat Hörnlimann, MPH. Managing Director, SVISS Consulting, BSE 7192 Ltd., an organization that provides expert advice on public and animal health, particularly with respect to BSE. Formerly Chief Veterinary Officer, Public Health Department, Kanton Zug, Switzerland. Led Swiss BSE and scrapie eradication program and served in numerous other senior-level staff and advisory positions related to TSEs. Author of a book on prions and prion diseases in humans and animals.

Dr. David Kessler. Dean, School of Medicine, Yale University and former Commissioner, U.S. Food and Drug Administration. Author of A Question of Intent (on federal tobacco regulation efforts) and numerous articles in major medical journals. Member, Board of Directors, Elizabeth Glaser Pediatric AIDS Foundation, Doctors of the World, National Center for Addiction and Substance, Henry Kaiser Family Foundation. Recipient of numerous medical public service awards, including the American Heart Association National Public Affairs Special Recognition Award, American Academy of Pediatrics Excellence in Public Service Award, and American Cancer Society Medal of Honor.

Dr. Colin Masters. Professor and Head, Department of Pathology, University of Melbourne. Specialist in neuropathology. Member, numerous national and international medical professional societies.

Dr. Carols Messuti. Ministry of Livestock, Agriculture, and Fishing, Government of Uruguay and Delegate to the OIE, the UN's principal agency for animal diseases.

Dr. Jeffrey W. Savell. Professor, E.M. ?Manny? Rosenthal Chairholder, and Leader, Meat Science Section, Department of Animal Science, Texas A&M University. Specialist in meat quality/consistency, food safety and nutrition. Past President, American Meat Science Association; member, Institute of Food Technologists, American Society of Animal Science, HACCP Alliance. Author or co-author of more than 250 articles and co-author of the Laboratory Manual for Meat Science. Recipient of numerous awards for research and teaching.

Dr. James Toole. Walter C. Teagle Professor of Neurology, Professor of Public Health Sciences, and Director, Stroke Research Center, Wake Forest University School of Medicine. President, International Stroke Society; member and past-president, World Federation of Neurology; member and past-president American Neurological Association; fellow, Royal College of Physicians; master, American College of Physicians. Author of Cerebrovascular Disorders and over 600 medical textbook chapters; co-editor Handbook of Clinical Neurology. Former editor, Journal of the Neurological Sciences.


http://www.mcdonalds.com/corp/values/socialrespons/resrecog/expert_advisors0/international_scientific.html




TSS
 

rkaiser

Well-known member
Please Terry,

Do you honestly think that anyone on this board has time to read your posts?

What is your opinion?

Is that not what this Bull Session is for?
 

flounder

Well-known member
rkaiser said:
Please Terry,

Do you honestly think that anyone on this board has time to read your posts?

What is your opinion?

Is that not what this Bull Session is for?



i didn't expect you to understand it rkaiser :lol2:

anything over two words and you get confused :wink:


TSS
 

flounder

Well-known member
flounder said:
rkaiser said:
Please Terry,

Do you honestly think that anyone on this board has time to read your posts?

What is your opinion?

Is that not what this Bull Session is for?



i didn't expect you to understand it rkaiser :lol2:

anything over two words and you get confused :wink:


TSS



I suppose just for you rkaiser, i will summarize.

in short ;

(now this may be more than just two words rkaiser, so please stay focused)


here goes ;


USA HIDING MAD COWS, while they were getting the BSE MRR policy signed, sealed, and delivered. ...


how was that, short enough ???

TSS
 
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