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From: TSS ()
Subject: Re: USDA botched testing of mad cow suspect
Date: July 22, 2005 at 12:27 pm PST

In Reply to: USDA botched testing of mad cow suspect posted by TSS on July 22, 2005 at 11:07 am:


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Saturday, June 25, 2005 4:53 PM
Subject: TAKING QUALITY BSE MAD COW SAMPLES IN USA


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


FOR folks not wanting to use GW et als (North America) Triple SSS policy for BSE surveillance,
please see below.


IF you go to page 65 out of 154 of the ;


Procedure Manual for

Bovine Spongiform

Encephalopathy (BSE)

Surveillance

October 2004


TAKING QUALITY BSE SAMPLES IN USA


NOTE: The samples in these photos are suitable for ELISA testing and if negative by ELISA

there would not be a problem, but if the results were inconclusive then it would be

difficult to process for IHC and additional testing.

ALSO, PLEASE see pages 119 - 133 for proper sampling collection protocols ;


http://www.aphis.usda.gov/vs/nvsl/BSE/bse_surveillance_manual.pdf

TSS

#################### https://lists.aegee.org/bse-l.html ####################


Subject: re-USDA's surveillance plan for BSE aka mad cow disease
Date: Mon, 02 May 2005 16:59:07 -0500
From: "Terry S. Singeltary Sr."
To: paffairs@oig.hhs.gov, HHSTips@oig.hhs.gov, contactOIG@hhsc.state.tx.us


Greetings Honorable Paul Feeney, Keith Arnold, and William Busby
et al at OIG,

snip...

full text of TSS submission to OIE on the TEXAS inconclusive and USA BSE
surveillance (or the lack of);

http://www.vegsource.com/talk/madcow/messages/94595.html


Taking a Quality Sample

Too Little Tissue Submitted Too Little Tissue Submitted

NOTE: The samples in these photos are suitable for ELISA testing and if
negative by ELISA
there would not be a problem, but if the results were inconclusive then it
would be
difficult to process for IHC and additional testing.

August 24, 2004 Taking a Quality Sample: E4

snip...end

http://www.aphis.usda.gov/vs/nvsl/BSE/Manual/appendixe.pdf


Getting a Sample of
Sufficient Quality
Unless the sample is of sufficient quality, it will be unusable and
not count towards the survey. Please see Appendix E for
guidance on collecting a quality sample. If the sample is not of
sufficient quality, STOP: DO NOT TAKE THE SAMPLE. This
does NOT apply to samples taken from:
• animals that are highly suspicious for BSE or that
involve an FAD investigation
• animals that were condemned in an antemortem
inspection
BSE sampling using a
spoon
Step 1
• Place head upright
– On head rack or barrel
– On table edge
– On the ground facing down if no other option

snip...

http://www.aphis.usda.gov/vs/nvsl/BSE/procedure_manual.pdf


Factsheet
Animal and Plant Health Inspection Service June 2005
APHIS
The U.S. Department of Agriculture (USDA) prohibits discrimination in all
its programs and activities on the basis of race, color, national
origin, sex, religion, age, disability, political beliefs, sexual
orientation, or marital or family status. (Not all prohibited bases apply to
all
programs.) Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA’s TARGET Center at (202) 720–2600 (voice and TDD).
To file a complaint of discrimination, write USDA, Director, Office of Civil
Rights, Room 326–W, Whitten Building, 1400 Independence
Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and
TDD). USDA is an equal opportunity provider and employer.
Safeguarding American Agriculture Animal and Plant Health Inspection
Service • United States Department of Agriculture •
Immunohistochemistry (IHC)
• Primary confirmatory test for
USDA’s BSE surveillance
program.
• Recognized by the World
Organization for Animal Health, or
OIE.
• Allows scientists to determine if a
sample is positive for BSE in two
distinct ways: visually (spongiform
changes), and through a staining
technique (presence of abnormal
prion protein).
• Involves looking at an intact
portion of the brain, the obex, to
see if there are lesions (holes or
a “spongy” appearance) present
that are characteristic for BSE,
and using a staining process
using antibodies that detect the
abnormal protein prion.
• Takes four to seven days to run.
• Freezing samples does not
interfere with performing the IHC
test as long as the sample is
confirmed as obex.
Western Blot
• Several types, with the SAF
Immunoblot being the one
recognized by OIE.
• Used under USDA protocol when
a sample is “not suitable for IHC”,
i.e., if it is autolyzed (or degraded)
or brain stem architecture is not
evident microscopically.
• Uses a large portion of obex brain
tissue; the abnormal prion protein
in brain material is enriched
by ultracentrifugation, and the
sample is exposed to protease,
an enzyme, to destroy any
normal prion proteins that may be
present, leaving only abnormal
prion proteins. Remaining
sample is then run through a gel
to separate the abnormal prion
protein components by molecular
weight. After the transfer of the
proteins to a membrane, proteins
are stained using antibodies that
can identify a specific banding
pattern associated with prion
diseases including BSE. A
diagnosis is made by recognizing
three distinctive bands that
are identified as a result of a
reaction with the anti-prion protein
antibody.
• Freezing samples does not
interfere with the performance of
western blot tests.
Similarities/Differences:
• Both IHC and the SAF Immunblot
(Western blot) are internationally
recognized as confirmatory tests
for BSE.
• The tests use different methods
to determine if the abnormal prion
protein is present in brain tissue
of an animal.
• The IHC test additionally allows
for the viewing of brain tissue to
determine if lesions characteristic
to BSE are present.
• Both tests are equally effective
at detecting the classical form of
BSE.
BSE Confirmatory Tests

http://www.aphis.usda.gov/lpa/pubs/fsheet_faq_notice/faq_BSE_confirmtests.pd
f


SAMPLE JOB AID

http://www.aphis.usda.gov/vs/nvsl/BSE/Manual/appendixd.pdf

Procedure Manual for Bovine Spongiform Encephalopathy (BSE) Surveillance
August 24, 2004 Page 16
Step 8
• You should be able to identify the Obex area of the brain
• Make sure your samples contain the Obex
• The Obex MUST be collected for the sample to be used
in BSE the surveillance data
Procedure Manual for Bovine Spongiform Encephalopathy (BSE) Surveillance
August 24, 2004 Page 17
Note:
• The area marked in black is the location of the Motor
Nucleus of the Vagus nerve
• The nucleus appears as “pink fleshy” areas
• This nucleus is the area we examine in the lab
• The pointer at the “V” is the Obex
Step 9
• Cut the samples as pictured
• The middle piece of tissue contains the Obex and the
Motor Nucleus of the Vagus
• The Obex is the key area
Procedure Manual for Bovine Spongiform Encephalopathy (BSE) Surveillance

snip...


http://www.aphis.usda.gov/vs/nvsl/BSE/procedure_manual.pdf


Procedure Manual for Bovine Spongiform Encephalopathy (BSE) Surveillance
Procedures for Obtaining and Submitting Samples from
Targeted High-Risk and Apparently Normal Cattle

□ Collect the brain stem, including the obex. Use a brain
tissue spoon or other suitable device. Sampling spoons and
tools will be provided by NVSL to sample collectors.

□ Prepare samples for shipping. Sample collectors must
evaluate the acceptability of the tissue sample. Samples that
are taken from the wrong location or that are significantly
autolyzed are not testable, and should not be submitted unless
specific arrangements are made in advance. The only
exception to this is for samples taken from cattle condemned
as a result of an antemortem inspection. See Appendix E for
guidance on taking and submitting a quality sample.

http://www.aphis.usda.gov/vs/nvsl/BSE/procedure_manual.pdf


USDA 2003

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

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


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


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

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

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


snip...


FULL TEXT;


Completely Edited Version
PRION ROUNDTABLE


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

http://www.vegsource.com/talk/madcow/messages/94513.html


HISTORY OF THIS COW AND TESTING OF IT;

http://www.vegsource.com/talk/madcow/messages/94622.html

Aguzzi Letter

http://www.vegsource.com/talk/madcow/messages/94620.html

Markus Moser Prionics BSE-L

http://www.vegsource.com/talk/madcow/messages/94621.html

Q&A Dr. Jean-Philippe Deslys

http://www.vegsource.com/talk/madcow/messages/94629.html


BIO-RAD

> > -------- Original Message --------
> > Subject: USA BIO-RADs INCONCLUSIVEs
> > Date: Fri, 17 Dec 2004 15:37:28 -0600
> > From: "Terry S. Singeltary Sr."
> > To: susan_berg@bio-rad.com
> >
> >
> >
> > Hello Susan and Bio-Rad,
> >
> > Happy Holidays!
> >
> > I wish to ask a question about Bio-Rad and USDA BSE/TSE testing
> > and there inconclusive. IS the Bio-Rad test for BSE/TSE that
complicated,
> > or is there most likely some human error we are seeing here?
> >
> > HOW can Japan have 2 positive cows with
> > No clinical signs WB+, IHC-, HP- ,
> > BUT in the USA, these cows are considered 'negative'?
> >
> > IS there more politics working here than science in the USA?
> >
> > What am I missing?
> >
> >
> >
> > -------- Original Message --------
> > Subject: Re: USDA: More mad cow testing will demonstrate beef's safety
> > Date: Fri, 17 Dec 2004 09:26:19 -0600
> > From: "Terry S. Singeltary Sr."
> > snip...end
> >
> >
> > Experts doubt USDA's mad cow results
>
>
>
> snip...END
>
> WELL, someone did call me from Bio-Rad about this,
> however it was not Susan Berg.
> but i had to just about take a blood oath not to reveal
> there name. IN fact they did not want me to even mention
> this, but i feel it is much much to important. I have omitted
> any I.D. of this person, but thought I must document this ;
>
> Bio-Rad, TSS phone conversation 12/28/04
>
> Finally spoke with ;
>
>
> Bio-Rad Laboratories
> 2000 Alfred Nobel Drive
> Hercules, CA 94547
> Ph: 510-741-6720
> Fax: 510-741-5630
> Email: XXXXXXXXXXXXXXXXXX
>
> at approx. 14:00 hours 12/28/04, I had a very pleasant
> phone conversation with XXXX XXXXX about the USDA
> and the inconclusive BSE testing problems they seem
> to keep having. X was very very cautious as to speak
> directly about USDA and it's policy of not using WB.
> X was very concerned as a Bio-Rad official of retaliation
> of some sort. X would only speak of what other countries
> do, and that i should take that as an answer. I told X
> I understood that it was a very loaded question and X
> agreed several times over and even said a political one.
>
> my question;
>
> Does Bio-Rad believe USDA's final determination of False positive,
> without WB, and considering the new
> atypical TSEs not showing positive with -IHC and -HP ???
>
> ask if i was a reporter. i said no, i was with CJD Watch
> and that i had lost my mother to hvCJD. X did not
> want any of this recorded or repeated.
>
> again, very nervous, will not answer directly about USDA for fear of
> retaliation, but again said X tell
> me what other countries are doing and finding, and that
> i should take it from there.
> "very difficult to answer"
>
> "very political"
>
> "very loaded question"
>
> outside USA and Canada, they use many different confirmatory tech. in
> house WB, SAF, along with
> IHC, HP, several times etc. you should see at several
> talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS
> NEGATIVE. again, look what
> the rest of the world is doing.
> said something about Dr. Houston stating;
> any screening assay, always a chance for human
> error. but with so many errors (i am assuming
> X meant inconclusive), why are there no investigations, just false
> positives?
> said something about ''just look at the sheep that tested IHC- but were
> positive''. ...
>
>
> TSS
>
> -------- Original Message --------
> Subject: Your questions
> Date: Mon, 27 Dec 2004 15:58:11 -0800
> From: To: flounder@wt.net
>
>
>
> Hi Terry:
>
> ............................................snip Let me know your phone
> number so I can talk to you about the Bio-Rad BSE test.
> Thank you
>
> Regards
>
>
>
> Bio-Rad Laboratories
> 2000 Alfred Nobel Drive
> Hercules, CA 94547
> Ph: 510-741-6720
> Fax: 510-741-5630
> Email: =================================
>
>
> END...TSS
>
>
> ######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html
##########
>
> =====================================================
> =====================================================
>
> END....TSS
>

FULL TEXT;

http://www.vegsource.com/talk/madcow/messages/94627.html


TSS TEXAS MAD COW LIVES !

still disgusted in Bacliff, Texas

Terry S. Singeltary Sr.

#################### https://lists.aegee.org/bse-l.html ####################

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Friday, July 22, 2005 1:15 PM
Subject: USDA botched testing of mad cow suspect


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

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Friday, June 24, 2005 10:06 PM
Subject: The IHC Test Variables (USA BSE SURVEILLANCE)


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

The IHC Test Variables:

• IHC has been the primary confirmatory test for

USDA’s BSE surveillance program and is recognized

by the World Organization for Animal Health, or OIE.

• IHC allows scientists to determine if a sample is

positive for BSE in two distinct ways:

1.) A staining technique (presence of abnormal

prion protein) that uses antibodies to detect

abnormal prion protein in the brain.

2.) A visual examination to determine whether there

are lesions (holes or "spongy" appearances)

present in the brain.

• Several variables could yield conflicting results:

o IHC is not a standardized, commercially

available test. It involves variables, including

several options in types of antibodies and other

reactive agents. The sensitivity of any given test

is influenced by those variables.

o If the level of infectivity in the animal is extremely

low, the abnormal prion in the brain will be

minimal and therefore more difficult to detect.

o Variations in the conditions under which the

staining process is performed, such as

chemicals and reactive agents used,

temperature and length of antibody exposure,

can also cause the test to yield different results.

Testing History on This Animal:

• In November 2004, a sample from this animal

returned inconclusive for BSE on a Biorad screening

test.

• The sample was subjected to an IHC confirmatory

test, which returned negative.

• USDA scientists also ran an additional, experimental

IHC "rapid" tissue fixation test for academic purposes,

which can be conducted more quickly than the IHC

confirmatory test and is therefore of interest to the

scientific community, but it has not been approved

internationally.

• While some abnormalities were noted in the

experimental IHC test results, because the test was

not a validated procedure, and because the two

approved IHC tests came back negative, the results

were not considered to be of regulatory significance

and therefore were not reported beyond the

laboratory.

• A Western blot test conducted the week of

June 5, 2005, returned positive for BSE.

• An additional IHC confirmatory test conducted the

week of June 13, 2005, by USDA scientists utilizing

different antibodies from the November 2004 test,

confirmed this case as weakly positive for BSE.

• The Veterinary Laboratories Agency in Weybridge,

England, conducted a series of diagnostic tests

including an IHC, using different antibodies from

those used by USDA in November 2004, which

returned positive results for BSE.

• Experts from the Weybridge lab confirmed the

accuracy of the results of USDA’s November

confirmatory IHC test, concurring that the case could

not have been confirmed on the basis of this sample.

• Weybridge experts also examined the November

experimental IHC test and interpreted the results to

be positive.

Potential Causes of Conflicting Results:

• USDA scientists are consulting with Weybridge

scientists to determine the cause of the conflicting

IHC test results.

• Several factors could cause or contribute to the

discrepancy as follows:

o This animal had a very low level of infectivity and

therefore the sensitivity of USDA’s routine IHC

test might not have been sufficient to detect the

disease.

o Weybridge experts indicate that deposits of

abnormal prion in the brain tissue were not

uniformly distributed and were present at low

concentration, which means that even adjacent

samples of brain tissue might not give identical

results.

Factsheet

Veterinary Services June 2005

APHIS

USDA Protocol Review:

• USDA will develop a protocol to conduct dual

confirmatory tests, the IHC and the Western blot,

when the screening test, the Biorad, returns an

inconclusive result.

• USDA and Weybridge scientists are in agreement

that the Biorad test is a very effective and appropriate

screening test.

• USDA scientists will consult with Weybridge scientists

to assess the array of antibodies available for use in

IHC confirmatory tests to determine the most

appropriate for use in United States confirmatory

tests. Those consultations will be repeated periodically.

The U.S. Department of Agriculture (USDA) prohibits discrimination

in all its programs and activities on the basis of race, color,

national origin, sex, religion, age, disability, political beliefs, sexual

orientation, or marital or family status. (Not all prohibited bases

apply to all programs.) Persons with disabilities who require alternative

means for communication of program information (Braille,

large print, audiotape, etc.) should contact USDA’s TARGET

Center at (202) 720–2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office

of Civil Rights, Room 326–W, Whitten Building, 1400

Independence Avenue, SW, Washington, DC 20250–9410 or call

(202) 720–5964 (voice and TDD). USDA is an equal opportunity

provider and employer.

Safeguarding American Agriculture Animal and Plant Health Inspection Service • United States Department of Agriculture •

http://www.usda.gov/documents/vs_bse_ihctestvar.pdf


THIS confirms that the June 2004 Enhanced BSE cover-up, was just that. Like i said before, due to this terribly flawed system, those 388,000 testing to date for BSE in the USA were meaningless and should be retested. ...

TSS

#################### https://lists.aegee.org/bse-l.html ####################


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Friday, June 24, 2005 10:12 PM
Subject: FDA Statement on USDA BSE Positive Test Results


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

FDA STATEMENT: June 24, 2005
Media Inquiries: Suzanne Treviño, 301-827-6242
Consumer Inquiries: 888-INFO-FDA


FDA Statement on USDA BSE Positive Test Results

"The Food and Drug Administration, along with the USDA, is committed to
ensuring the safety of the U.S. human food and animal feed supply from BSE
(bovine spongiform encephalopathy). Today we saw that the system worked.
The safety measures that FDA and USDA have put in place successfully kept
this animal that has tested positive for BSE out of the food and feed
supply. These existing safeguards have proven extremely effective, and the
American public should feel secure in knowing that the current animal feed
rule already provides significant protection against the spread of BSE. We
will continue to work closely with the USDA on this important public health
issue and evaluate every option to strengthen the 1997 animal feed ban."


####


http://www.fda.gov/bbs/topics/NEWS/2005/NEW01193.html


>We will continue to work closely with the USDA on this important public health issue <

damn, i wish they could make there mind up. you got johann et al saying it is NOT a public health issue, and the FDA saying it IS. i know it is, but i wish they would get there stories straight.

I remember similar statements made by USDA/APHIS et al before, when that 2003 Washington Cow old Dave capped, that _healthy walker_ not a downer, i remember those same similar statements at first.

I am very curious;

1. cohorts history of this animal, the same feed they ate as the cow that tested postive. so where are they and who comsumed them?

2. the feed this animal ate. where was it purchased and what other cows consumbed this feed?

3. ITS been 8 months and we still dont know officially the exact location of this animal. where was this animal from? exact location. the consumer needs to know.

what happened to all that timely information we were to recieve?

what about those that consumed the other cohorts of the other mad cow in the USA?


* GAO-05-51 October 2004 FOOD SAFETY (over 500 customers receiving
potentially BSE contaminated beef) - TSS 10/20/04


October 2004 FOOD SAFETY
USDA and FDA Need
to Better Ensure
Prompt and Complete
Recalls of Potentially
Unsafe Food

snip...

Page 38 GAO-05-51 Food Recall Programs
To examine the voluntary recall of beef products associated with the
December 2003 discovery of an animal infected with BSE, we analyzed the
distribution lists USDA collected from companies and the verification
checks it conducted to develop a diagram illustrating the location and
volume of recalled beef that reached different levels of the distribution
chain. We compared the distribution lists and verification checks to
identify how many customers listed on the distribution lists did not
receive
the recalled beef and the number of customers not listed on distribution
lists that received the recalled beef. We interviewed USDA and FDA staff
involved with the recall to understand the timing of recall actions and the
challenges encountered during the recall.
To develop information on the 2002 recall of ground beef by a ConAgra
plant in Greeley, Colorado, we reviewed USDAs recall file and other
documents on the recall. We also met with the departments Office of
Inspector General and reviewed the Inspector Generals September 2003
report.1
We conducted our review from May 2003 through August 2004 in
accordance with generally accepted government auditing standards.
1U.S. Department of Agriculture, Office of Inspector General, Great
Plains Region Audit
Report: Food Safety and Inspection Service: Oversight of Production
Process and Recall at
ConAgra Plant (Establishment 969), Report No. 24601-2-KC (September 2003).
Page 39 GAO-05-51 Food Recall Programs
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE Appendix II
On December 23, 2003, USDA announced that a cow in the state of
Washington had tested positive for BSEcommonly referred to as mad
cow disease. This appendix describes the actions USDA took to recall the
meat and the actions FDA took with respect to FDA-regulated products,
such as animal feed and cosmetics, made from rendered parts of the
animal.
Beef Recall Was
Triggered by a BSEPositive
Sample from
One Cow
On December 9, 2003, the recalling company slaughtered 23 cows. USDA,
in accordance with its BSE surveillance policy at the time, took a
sample of
1 cow that was unable to walk, although the condition of the tested cow is
now disputed. USDA did not process the sample in its Ames, Iowa National
Veterinary Services Laboratory in an expedited manner because the cow
did not show symptoms of neurological disorder. USDA test results
indicated a presumptive positive for BSE on December 23, 2003.
Recall Begun in
December 2003 Was
Completed in March
2004
On December 23, 2003, after learning about the positive BSE test, USDA
headquarters notified the Boulder District Office, which is the field
office
with jurisdiction over the recalling firm. The Boulder District began
gathering information about the recalling companys product distribution.
Field staff telephoned the recalling company and were on-site at 7:00 p.m.
The Boulder District initially thought 3 days of the recalling companys
production would have to be recalled, but further examination of facility
cleanup and shipping records revealed that it was only necessary to
recall 1
day of production. USDA recall staff convened at 9:15 p.m. and discussed
the science related to BSE and whether the recalling companys cleanup
practices were sufficient to limit the recall to 1 day of production.
Following USDAs determination to conduct a Class II recallthat is, the
beef posed a remote possibility of adverse health consequencesUSDA
contacted the recalling company to discuss recall details and the press
release. The press release and Recall Notification Report were released
that evening.
On December 24, 2003, USDAs Food Safety and Inspection Service (FSIS)
sent inspectors to the recalling companys primary customers to obtain
secondary customer distribution lists and product shipping records. USDA
conducted 100 percent verification checks for this recallit contacted
every customer that received the recalled meat. This level of verification
checks is well above the percentage of checks conducted by USDA district
offices for the Class I recalls we reviewed.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 40 GAO-05-51 Food Recall Programs
On December 26, 2003, USDA began checking the primary and secondary
customers of the recalling company that it was aware of, although the
entire product distribution chain was unknown. During the checks, USDA
tried to determine if the product was further distributed, and it used
verification checks to acquire distribution lists for secondary and
tertiary
customers of the recalling company.
Verification checks continued until February 25, 2004. Three USDA
districts conducted these verification checks. The Boulder District
coordinated the checks and assigned checks to the Minneapolis District
Office for customers in Montana and to the Alameda District Office for
customers in California. USDA required that 100 percent of the primary
checks, 50 percent of the secondary checks, and 20 percent of the tertiary
checks be conducted on-site. According to USDA, more than 50 percent of
the secondary checks were actually conducted on-site. FDA officials
helped conduct verification checks. According to USDA, the recall took a
long time to complete because USDA contacted each customer at least
twice. USDA first contacted each customer to conduct the check and again
to verify product disposition.
On February 25, 2004, the Boulder District concluded that the recall was
conducted in an effective manner. On March 1, 2004, USDAs Recall
Management Division recommended that the agency terminate the recall,
and USDA sent a letter to the recalling company to document that USDA
considered the recall to be complete.
Recall Was
Complicated by
Inaccurate Distribution
Lists and Mixing of
Potentially
Contaminated and
Noncontaminated Beef
USDA used distribution lists and shipping records to piece together where
the recalled product was distributed. According to USDA, one of the
recalling companys three primary customers was slow in providing its
customer list. USDA could not begin verification activities for that
primary
customer without this list. Furthermore, some customers of the recalling
company provided USDA with imprecise lists that did not specify which
customers received the recalled product. As a consequence, USDA could
not quickly determine the scope of product distribution and had to take
time conducting extra research using shipping invoices to determine which
specific customers received the product.
Even when USDA determined the amount and location of beef, the agency
still had trouble tracking the beef in certain types of establishments,
such
as grocery store distributors. USDA could not easily track the individual
stores where those distributors sent the beef because of product mixing
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 41 GAO-05-51 Food Recall Programs
and the distributors record-keeping practices. Generally, distributors
purchase beef from multiple sources, mix it in their inventory, and lose
track of the source of the beef they send to the stores that they
supply. To
deal with this problem, USDA first identified the dates when recalled beef
was shipped to the distributors and then asked for a list of the stores
that
were shipped any beef after those dates. Consequently, some stores were
included in the recall that may never have received recalled beef.
The recall was also complicated by repeated mixing of recalled beef with
nonrecalled beef, thereby increasing the amount of meat involved in the
recall. The recalling company slaughtered 23 cows on December 9, 2003,
and shipped those and 20 other carcasses to a primary customer on
December 10, 2003. The recalling companys carcasses were tagged to
identify the slaughter date and the individual cow. The primary customer
removed the identification tags and mixed the 23 recalled carcasses with
the 20 nonrecalled carcasses. Because the carcasses could not be
distinguished, the recall included all 43 carcasses at the primary
customer.
After one round of processing at the primary customer, the meat from the
carcasses was shipped to two other processing facilities. Both
establishments further mixed the recalled meat from the 43 carcasses with
meat from other sources. In all, the mixing of beef from 1 BSE-positive cow
resulted in over 500 customers receiving potentially contaminated beef.
Imprecise distribution lists and the mixing of recalled beef combined to
complicate USDAs identification of where the product went. Specifically,
on December 23, 2003, USDAs initial press release stated that the
recalling
company was located in Washington State. Three days later, on December
26, 2003, USDA announced that the recalled beef was distributed within
Washington and Oregon. On December 27, 2003, USDA determined that one
of the primary customers of the recalling firm distributed beef to
facilities
in California and Nevada, in addition to Washington and Oregon, for a total
of four states. On December 28, 2003, USDA announced that some of the
secondary customers of the recalling company may also have distributed
the product to Alaska, Montana, Hawaii, Idaho, and Guam, for a total of
eight states and one territory.
On January 6, 2004, over 2 weeks from recall initiation, USDA determined
that the beef went to only six statesWashington, Oregon, California,
Nevada, Idaho, and Montanaand that no beef went to Alaska, Hawaii, or
Guam. To reach that conclusion, USDA used the distribution lists, shipping
records, and sales invoices that it received from companies to piece
together exactly where the recalled beef may have been sent. The lists
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 42 GAO-05-51 Food Recall Programs
showed that 713 customers may have received the recalled beef; 6 of those
may have received beef from more than one source. USDA determined that
176 customers on the lists did not actually receive recalled beef,
including
the customers in Guam and Hawaii. USDAs review also indicated that
recalled beef was probably not shipped to Alaska or Utah, and USDA
checked 2 retailers in Alaska and 3 retailers in Utah to confirm that
was the
case. In total, USDA conducted verification checks on 537 of the 713
customers on the lists. USDAs initial checks identified an additional 45
customers that may have received the recalled beef that were not included
on the distribution lists, for a total of 582 verification checks. Figure 4
summarizes USDAs verification efforts during the recall.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 43 GAO-05-51 Food Recall Programs
Figure 4: USDAs Recall Verification Checks by Location and Customer
Type for Meat Associated with the Animal Infected with
BSE
Note: USDA checked 15 primary, 40 secondary, and 526 tertiary customers
plus the recalling
company, for a total of 582 verification checks.
USDAs press release stated that the recall involved 10,410 pounds of beef
products, and the USDA recall coordinator for this recall told us that
downstream processors mixed the recalled beef with nonrecalled beef, for
a total of more than 38,000 pounds of beef that was distributed at the
secondary customer level. According to USDA officials involved with the
D = Distributor
R = Retailer
SF = Storage facility
P = Processor
Primary customers
(15 total)
Recalling
slaughterhouse
(WA) 1 R
(OR)
1 P
(WA) 1 P
(OR)
1 P
(OR)
11 R
(WA)
Secondary customers
(40 total)
Tertiary customers
(526 total)
1 R
(OR)
1 SF
(OR)
3 D
(OR)
3 D
(WA)
2 dual D
(OR)
59 R
(OR)
79 R
(WA)
5 R
(ID)
3 R
(UT)
4 R
(MT)
161 R
(WA)
8 R
(ID)
15 R
(OR)
2 R
(AK)
31 R
(OR) 8 R
(WA)
10 R
(NV)
5 R
(ID)
10 R
(CA)
2 R
(CA)
17 R
(OR)
5 R
(WA)
1 D
(NV)
11 R
(CA)
85 R
(NV)
3 D
(OR) 11 R
(OR)
2 D
(CA) 26 R
(CA)
2 R
(WA)
( ) Acronyms in parentheses are postal abbreviations for each state.
Source: GAO analysis of USDA verification check documents.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 44 GAO-05-51 Food Recall Programs
recall, the precise amount of meat that was sold at the retail level is
unknown because retailers at the tertiary level further mixed nonrecalled
meat with potentially contaminated meat. USDA told us that more than
64,000 pounds of beef was ultimately returned or destroyed by customers,
and that, because of the mixing, it was not able to determine how much of
the original 10,410 pounds of recalled beef was contained in the 64,000
pounds that were recovered.
FDAs Role in USDAs
Recall
Parts of the BSE-infected animal slaughtered on December 9, 2003, were
not used for food, but they were sent to renderers to be separated into raw
materials, such as proteins and blood. Rendered materials are used for
many purposes, including cosmetics and vaccines. FDA has jurisdiction
over renderers.
When USDA learned of the BSE-infected cow on December 23, 2003, the
agency immediately notified FDA. On December 24, 2003, FDA sent an
inspection team to a renderer that handled materials from the BSE cow.
Inspectors confirmed that the parts of the slaughtered BSE positive cow
were on the premises. FDA later identified a second company that
potentially rendered material from the slaughtered BSE cow. Both
renderers agreed to voluntarily hold all product processed from the
diseased cow and dispose of the product as directed by FDA and local
authorities.
On January 7, 2004, 15 containers of potentially contaminated, rendered
material (meat and bone meal) were inadvertently loaded on a ship, and on
January 8, 2004, the ship left Seattle, Washington, for Asia. The renderer
initiated steps to recover the shipped material, so it could be disposed
of as
directed by FDA and local authorities. The ship carrying the material
returned to the United States on February 24, 2004, and the material was
disposed of in a landfill on March 2, 2004.
On January 12, 2004, FDA asked both renderers to expand their voluntary
holds to rendered materials processed from December 23, 2003, through
January 9, 2004, because they may have rendered some recalled meat or
trim that was recovered from retail establishments. Both renderers agreed
to the expanded product hold. In total, FDA requested that renderers
voluntarily hold approximately 2,000 tons of rendered material. FDA
confirmed that none of the potentially contaminated, rendered material
entered commerce, because FDA accounted for all rendered material. FDA
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 45 GAO-05-51 Food Recall Programs
reported that no recall was necessary because no product was distributed
commercially by the rendering companies.
USDA and FDA
Worked Together on
the Recall
USDA and FDA worked together in two ways. First, both agencies notified
each other if their investigations yielded any information about products
within the jurisdiction of the other agency. For instance, when conducting
the second round of verification checks, USDA tracked the disposition of
the product to renderers and landfills and notified FDA when the product
went to renderers. Second, FDA officials helped conduct verification
checks. FDA conducted 32 of the 582 verification checks (approximately 5
percent) for the USDA recall. Officials from both agencies indicated they
regularly interacted and shared information. Table 3 outlines the agencies
actions.
Table 3: Detailed Timeline of USDA, FDA, and Company Actions Related to
the Discovery of an Animal Infected with BSE
Date USDA recall actions FDA actions Company actions
12/9/03 " USDA samples cow for BSE. " BSE cow is slaughtered.
12/11/03 " Sample is sent to Ames, Iowa, for BSE
testing.
" Recalling company sends
carcasses to primary customer for
processing.
12/12/03 " Primary customer sends meat
products to two other primary
customers for further processing.
12/12 -
12/23/03
" Other primary customers distribute
recalled product to secondary
customers.
" Secondary customers distribute
recalled product to tertiary
customers.
12/23/03 " BSE test results are presumptively
positive.
" Recall meeting.
" Initiation of voluntary recall.
" Press release.
" FDA notified of BSE test results.
" FDA dispatches investigation teams.
12/24/03 " FDA inspects Renderer 1.
" FDA determines some rendered
material from Renderer 1 is intended
for Indonesia.
" FDA discovers some material may
have been sent to Renderer 2.
" Renderer 1 agrees to hold remaining
rendered material.
" Recalling company contacts
primary customers.
" Primary customers contact their
customers.
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 46 GAO-05-51 Food Recall Programs
12/25/03 " USDA receives confirmation from
reference lab in England that cow in
question is BSE positive.
12/26/03 " Verification checks begin
" USDA announces recalled product in
Washington State and Oregon.
" FDA begins process of comparing
records to ensure all products from
Renderers 1 and 2 are accounted for.
" Renderer 2 agrees to hold all material
that may have been derived from
BSE cow. None of the rendered
material has been distributed.
12/27/03 " USDA announces recalled product was
distributed in Washington State,
Oregon, California, and Nevada.
" FDA issues statement confirming that
the rendering plants that processed
all of the nonedible material from the
BSE cow have placed a voluntary
hold on all of the potentially infectious
product, none of which had left the
control of the companies and entered
commercial distribution.
12/28/03 " USDA announces recalled product was
distributed in Washington State,
Oregon, California, Nevada, Montana,
Idaho, Alaska, Hawaii, and Guam.
12/29/03 " Food Safety and Inspection Service
determines that the recalled meat
products were distributed to 42
locations, with 80 percent of the
products distributed to stores in
Oregon and Washington State.
12/31/03 " FDA offers assistance to USDA to
complete recall verification checks.
1/6/04 " USDA determines recalled product
was only distributed in Washington
State, Oregon, California, Nevada,
Montana, and Idaho.
1/8/04 " FDA is notified by the renderer that
some of the rendered material on
hold from Renderer 1 was
inadvertently shipped to Asia.
Renderer 1 commits to isolate and
return the rendered material.
" Rendering company notifies FDA of
shipment of product on hold.
(Continued From Previous Page)
Date USDA recall actions FDA actions Company actions
Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE
Page 47 GAO-05-51 Food Recall Programs
Source: GAO analysis of USDA and FDA information.
1/12/04 " FDA advises Renderers 1 and 2 that
they may have rendered meat or trim
subject to recall from retail stores.
" FDA requests Renderers 1 and 2 to
place all rendered material from
December 23 to January 9 on hold.
" FDA determines neither renderer had
shipped rendered material
manufactured after December 23,
2003.
2/9/04 " All rendered material was disposed of
in landfill, except material shipped to
Asia.
2/24/04 " Ship carrying rendered material
returns to U.S. port.
2/25/04 " Verification checks complete.
" USDA Boulder District Office
concludes recall is effective.
3/1/04 " Recall is closed.
3/2/04 " FDA observes disposal in landfill of
remaining rendered material...

snip...

REPORTS

1. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete
Recalls of Potentially Unsafe Food. GAO-05-51, October 7.tss
http://www.gao.gov/cgi-bin/getrpt?GAO-05-51
Highlights - http://www.gao.gov/highlights/d0551high.pdf


USDA botched testing of mad cow suspect
By Steve Mitchell
Medical Correspondent
Jul. 21, 2005 at 5:44PM

U.S. Department of Agriculture officials tracing cattle that may have been associated with the country's first case of mad cow disease in 2003 botched the testing of a cow considered "at risk" and did not run a confirmatory test called a Western blot, according to agency documents obtained by United Press International.
The documents, obtained via the Freedom of Information Act, show a pattern that is similar to how the agency handled a Texas cow that was initially ruled negative but seven months later was found to be positive for the deadly disease on the Western blot test.
The cow related to the 2003 case appears to have arrived from Canada in the same herd as the infected animal and resided at the same dairy cattle finishing farm in Washington state. The USDA found the animal at a farm in Mabton, Wash., and was testing it for mad cow -- formally known as bovine spongiform encephalopathy, or BSE -- because it was deemed to be at risk for the disease.
The USDA documents indicate an ELISA rapid test was run that turned out negative. This was followed by a test called immunohistochemistry, or IHC, that also came back negative, but the result was coded as "loc" instead of the usual "neg."
A note in the document states the "loc" notation "means that the IHC test was negative, but the wrong location of the brain was sampled for testing. There is no longer any possibility to test the proper location."
BSE experts said the notation did not make sense and questioned why the agency did not run a Western blot test, which may have helped determine if the cow was carrying BSE.
"That's bizarre," Markus Moser, a molecular biologist and chief executive officer of Prionics, a Swiss firm that manufactures BSE test kits, told UPI.
"If the ELISA has been done on the correct piece of brain, then it was done on the obex," Moser said. "If it was done correctly, then it was done on one hemisphere of the obex and you have the other hemisphere for IHC or another test. If they say they don't have any correct tissue for doing that, then what exactly did they use for the first ELISA?"
If the ELISA test was run on an incorrect portion of the brain, then its results are unreliable.
USDA officials acknowledged there were problems with the brain sample.
"The person who collected the sample made a notation that the sample was not a good sample, meaning it could have been torn or mangled," agency spokeswoman Amy Spillman told UPI.
This applied only to the IHC test, however. She said there was no indication the sample was unsuitable for the ELISA test.
"They didn't make any notes the sample wasn't viable for ELISA, so we would assume it would be acceptable for" that test, Spillman said.
Moser said he still would run the Western blot test in a case like this, even if the correct brain region was not available.
Another renowned BSE testing expert agreed it would have been appropriate to run the Western blot test.
The expert, who spoke to UPI on condition of anonymity, said there are several reasons why the obex may have been damaged or found to be unsuitable for IHC tests.
"The best you can do is to throw more tests at it," the expert said, "especially ones that concentrate prion protein (thought to be the mad cow agent), such as the SAF Immunoblot (Western blot), and if that still comes up negative too, forget it."
Spillman said the Western blot was not run because it "wasn't part of our protocol then."
The USDA also failed to run the Western blot on the Texas cow that last month was deemed positive, making it the second case of the disease detected in U.S. herds.
That cow had tested positive on two rapid tests last November, but the agency subsequently ran an IHC test and told the public it had come back negative. It was not until June -- and at the insistence of the agency's inspector general -- that the USDA would run a Western blot that came back positive.
In announcing the June results, the USDA also informed the public that one of three IHC tests run in November had come back positive. This was not disclosed in November, and the revelation still has experts questioning why the agency would ignore a positive result and not run further tests -- such as a Western blot -- to determine more precisely if the cow was infected.
The finding of a BSE-infected cow can have major economic consequences. A recent study conducted by Kansas State University researchers calculated the U.S. beef industry already has lost billions of dollars in exports due to foreign nations closing their borders in response to the 2003 mad cow case.
In the past, the USDA has been quick to use the Western blot to confirm or rule out cases. In 1997 two cows that initially were suspected of having mad cow were tested using both the IHC and Western blot. Neither showed evidence of infection. Even in the 2003 case, the infected animal was retested using Western blot to confirm it had the disease.
The USDA changed its policy after the Texas cow blunder, stating it would run both the IHC and the Western blot on cows that initially test positive on rapid tests.
Michael Hansen, with the watchdog group Consumers Union, said the agency's failure to run the Western blot raises questions about the validity of the BSE surveillance program.
"You don't know whether it's incompetence or some nefarious scheme, but its very Keystone Coppish," said Hansen, a biologist and senior research associate with CU.
"Neither of those possibilities -- gross bureaucratic incompetence or political interference suggesting a coverup -- instills confidence in the public that the agency is doing the right thing," he told UPI.
Another BSE expert told UPI of a similar problem with the USDA lab on a sheep that was tested for scrapie, a similar disease to BSE. The expert had observed the brain being extracted from the sheep and knew it was the correct region for testing, but the USDA lab later said it received the wrong brain region.
UPI previously reported that from 2001 to 2003 the USDA collected the wrong part of the brain in more than 200 cows that were being screened as part of its BSE surveillance program.
The USDA documents also indicate the agency never was able to identify or test 52 cows that came into the United States in 2001 along with the Washington cow that tested positive in 2003. Of these, 11 were considered to be "high risk" because they were born within a year and on the same premises as the infected cow.
These cows may have gone into the food supply and been consumed by people. The concern is humans can contract a fatal brain disease from eating beef products contaminated with the mad cow pathogen.
"It's possible those animals went to slaughter, but (USDA) would've done ante-mortem inspection and if those animals had exhibited signs (of BSE) they wouldn't have been allowed into the food chain," Spillman said.
Hundreds of seemingly healthy animals in Europe have tested positive for the disease, however, and several eyewitnesses said the infected Washington cow was walking and did not appear ill the day of slaughter.
The USDA's inability to locate these cows demonstrates the need for a stronger animal-identification program so officials can trace the final destinations of animals if there is a problem, Hansen said.
--
E-mail: sciencemail@upi.com


http://www.washtimes.com/upi/20050721-043953-6306r.htm


TSS

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