Subject: OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local
cattle dealers i.e. USDA
Date: May 14, 2007 at 9:00 am PST
OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle
dealers i.e. USDA
STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION
March 9, 2007
"In October 2006, the U.S. Department of Agriculture submitted an
application and supporting documents to the World Organization for Animal
Health (OIE) to formally request country classification for bovine
spongiform encephalopathy (BSE) risk. The OIE undertakes a thorough review
process before recommending a risk classification, and then provides an
opportunity for all delegate countries to review the recommendations and
present comments prior to final adoption of a country's classification at
the OIE's General Assembly meeting in May.
"While we recognize that a final classification decision will not be made by
the OIE until May, we feel it is important to be responsive to questions we
are now being asked about the risk classification recommended for the United
States. The OIE Scientific Commission has endorsed the recommendation from
an OIE expert panel that the United States be classified as "controlled
risk" for BSE.
"The controlled risk classification recognizes that OIE-recommended,
science-based mitigation measures are in place to effectively manage any
possible risk of BSE in the cattle population. This recommendation provides
strong support that U.S. regulatory controls are effective and that U.S
cattle and products from cattle of all ages can be safely traded in
accordance with international guidelines, due to our interlocking
safeguards.
"The OIE risk classification process is an essential step in promoting trade
and understanding of this disease. We appreciate OIE's review of our
application, as well as its leadership in developing sound, science-based
guidelines that will help countries standardize regulations and import
requirements. We look forward to the final adoption of this classification,
which will be announced at the OIE meeting in May."
#
http://www.aphis.usda.gov/newsroom/content/2007/03/OIE_statement3-9-07.shtml
Sample Size Estimate for BSE Ongoing Surveillance
July 20, 2006
Purpose, rationale, and objectives of surveillance
Animal and public health concerns about bovine spongiform encephalopathy
(BSE) have led to the establishment of active surveillance programs among
other
regulatory measures to monitor and prevent disease. Active surveillance for
BSE was initiated in the United States in 1990. In response to
identification of a BSE-affected imported dairy cow in December 2003, the
U.S. Enhanced BSE Surveillance Program was implemented in June 2004. Through
these efforts, two cases of BSE were identified through March 2006. Both
cases were in beef cattle over 10 years old (born before the feed ban of
1997), one located in Texas and one in Alabama.
Based on data collected in the United States over the last 7 years,
including over a half million samples from the Enhanced Surveillance
program, the USDA has
developed an estimate of prevalence of BSE among U.S. cattle that was
extremely low, projected at less than one case per million animals in the
standing adult cattle population at the 95 percent confidence level (APHIS
2006a). In addition, the USDA demonstrated that surveillance efforts to date
far exceed the World Organization for Animal Health (OIE) "type A"
surveillance recommendations. Prevalence is expected to decline as long as
mitigation efforts that maintain low risk for introduction and spread of the
BSE agent among U.S. cattle are equivalent to or better than those evaluated
by the Harvard Risk Assessment (Cohen et al., 2001, 2003).
The principal purposes of ongoing BSE surveillance are:
1. To continue to monitor the BSE status of U.S. cattle.
2. To provide mechanisms for detection of BSE prevalence if it were to
increase above 1 infected animal per million adults.
In addition, we aim to meet the objective of conducting ongoing surveillance
at a level that meets or exceeds OIE surveillance recommendations. We
believe this
objective is reached by the following sampling strategy, which is sufficient
to detect BSE at 1 infected animal per 1,000,000 adult cattle in the
population with a high
degree of confidence.
Sample Size to Meet OIE Surveillance Recommendations
APHIS is committed to maintaining BSE surveillance that at least meets OIE
guidelines. The OIE surveillance guidelines for BSE recommend a target
number of
surveillance points for Type A surveillance based on the size of a country's
cattle population. These points are accrued over 7 consecutive years, and
are weighted according to the surveillance stream and age of the animal
sampled. For a large cattle population, using the design prevalence of 1
case per 100,000 adult cattle and 95 percent confidence, 300,000 total
points over 7 years, or 42,857 points per year, are required for Type A
surveillance (OIE 2005).
The four surveillance streams identified in the OIE Code are clinical
suspects; casualty slaughter; fallen stock; and healthy slaughter. OIE
guidelines recommend
sampling from at least three of the four surveillance streams. BSE
surveillance efforts in the United States have always focused on the three
surveillance streams where BSE is more likely to be found – clinical
suspects, casualty slaughter, and fallen stock. During the 7 consecutive
years prior to March 17, 2006, the United States collected 735,213 BSE
samples from these surveillance streams and accumulated 2,973,804 OIE points
(APHIS 2006b).
As shown in the calculation below, if the ongoing surveillance plan
continues similar sample numbers from these surveillance streams,
approximately 10,500 cattle
per year would be sufficient to meet the OIE minimum number of sample points
for Type A surveillance.
2,973,804 points ÷ 735,213 samples = 4.1 points per sample and 42,857 points
required per year ÷ 4.1 points per sample = 10,453 samples per year
Sample Size for BSE Prevalence Estimates
The OIE minimum number of samples as outlined would be sufficient for a
design prevalence of 1 case per 100,000 adult cattle. However, in the
interest of
maintaining confidence in previous BSE prevalence estimates, a more
sensitive design prevalence of 1 case per 1 million adult cattle will be
adopted for ongoing surveillance. The BSurvE model (Wilesmith et al., 2004)
can be used to help estimate the number of samples necessary to achieve this
level of detection. This model determines sample point values based on a
particular population's demographics.
The point tables described by OIE surveillance guidelines were designed
using the BSurvE model to represent a conservative scenario (e.g., low point
value and
greater number of samples) of the characteristics of the cattle populations
of all of its member countries. These demographic characteristics describe a
hypothetic
population that culls cattle very rapidly (mean age of approximately 4
years) and results in point values that are lower than the BSurvE model
would calculate for cattle in most countries. In the United States, however,
demographic data indicate 25 percent of the adult cattle population of
approximately 42 million are dairy production type and 75% are percent beef
cattle (NASS 2005). While the U.S. dairy population undergoes rapid culling
similar to the characteristics used to develop the OIE table, beef cattle
generally remain in the herd to a much older age until they no longer
produce calves. Because actual U.S. data are available regarding population
characteristics, it is appropriate to base the sample size estimates on the
points calculated through BSurvE given U.S. demographics (these points are
hereafter referred to as "analytical points"). The higher average age at
which beef cattle are culled influences the BSurvE output and results in
substantially higher point values. Hence, sample values calculated with
BSurvE from actual U.S. data result in higher point values than the
conservative OIE estimates. Each analytical point calculated by BSurvE
corresponds to a single nontargeted sample (Wilesmith et al., 2004).
According to OIE, BSurvE and Cannon and Roe (1982) calculations, the
required number of non-targeted samples needed to detect a prevalence of 1
case per million adult cattle with 95% confidence (given a population size
of 42 million adult cattle) is 3,000,000, 2,995,730, and 2,891,389,
respectively. Conservatively using the value of 3 million, we calculate that
we will need to accumulate 428,571 analytical points (with negative results)
per year across a period of 7 years to meet this objective. 3,000,000
analytical points ÷ 7 years = 428,571 analytical points per year The
prevalence analysis conducted on U.S. surveillance data collected from
March, 1999 through March 2006 reports 6,745,010 points resulting from
735,213 samples. The average sample was worth 9.5 analytical points.1
6,745,010 analytic points ÷ 735,213 samples = 9.5 analytic points per sample
If USDA maintained an equivalent mix of surveillance streams during ongoing
surveillance, then approximately 45,113 samples per year would be required
to meet this objective. 428,571 analytical points per year ÷ 9.5 analytical
points per sample = 45,113 samples per year However, greater than one half
million of the samples from Enhanced Surveillance were collected from fallen
stock – the surveillance stream that produced the lowest point values.
Sampling efforts can be focused on higher value surveillance streams –
clinical suspects and casualty slaughter – with a limited number of samples
obtained from the fallen stock surveillance stream. This will substantially
increase the average point value per sample. Therefore, we estimate that
40,000 samples collected from these three surveillance streams – with a
focus on clinical suspects and casualty slaughter - will
exceed the number of points necessary to maintain confidence that prevalence
is less than one infected animal per million adult cattle. Further, since
the data are
analyzed over 7 consecutive years, the estimate of sample size may be
adjusted each year as appropriate to assure a robust prevalence estimate.
References:
APHIS (Animal and Plant Health Inspection Service) (2006a). An Estimate of
the Prevalence of BSE
in the United States. USDA: APHIS: VS: Centers for Epidemiology and Animal
Health, National
Surveillance Unit. Accessed May 5, 2006, online at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/BSEprevalenceestimate4-
26-06.pdf
APHIS (Animal and Plant Health Inspection Service) (2006b). Summary of BSE
Enhanced
Surveillance in the United States. USDA: APHIS: VS: Centers for Epidemiology
and Animal Health,
National Surveillance Unit. Accessed May 5, 2006, online at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/SummaryEnhancedBS
E-Surv4-26-06.pdf
Cannon RM, Roe RT (1982). Livestock Disease Surveys: A Field Manual for
Veterinarians, Australian
Bureau of Animal Health, Canberra.
Cohen JT, Duggar K, Gray G, Kreindel S, Abdelrahman H, HabteMariam T, Oryang
D, Tameru B
(2001, 2003). Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States.
Harvard Center for Risk Analysis/Harvard School of Public Health and Center
for Computational
Epidemiology, College of Veterinary Medicine, Tuskegee University. November
2001, (revised
October 2003). Available at
http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
NASS (2005) Cattle, National Agricultural Statistics Service, USDA.
Washington, D.C. Released
January 28, 2005, by the National Agricultural Statistics Service (NASS),
Agricultural Statistics
Board, U.S. Department of Agriculture. Available December 15, 2005, at:
http://usda.mannlib.cornell.edu/reports/nassr/livestock/pct-bb/catl0101.txt
OIE (Office International des Epizooties) (2005). Appendix 3.8.4:
Surveillance for bovine spongiform
encephalopathy. In: Terrestrial animal health code, 14th ed., Paris, 2005.
Wilesmith J, Morris R, Stevenson M, Cannon R, Prattley D, and Benard H
(2004). Development of a
Method for the Evaluation of National Surveillance Data and Optimization of
National Surveillance
Strategies for Bovine Spongiform Encephalopathy. European Union TSE
Community Reference
Laboratory, Veterinary Laboratories Agency, Weybridge, England.
http://www.aphis.usda.gov/peer_review/downloads/BSE_sample_size_ongoing_surv_after.pdf
does not compute. fuzzy math. full formula below. ...TSS
-MORE
Office of the United States Attorney
District of Arizona
FOR IMMEDIATE RELEASE For Information Contact Public Affairs
February 16, 2007 WYN HORNBUCKLE
Telephone: (602) 514-7625
Cell: (602) 525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY
TO DEFRAUDING GOVERNMENT'S MAD COW DISEASE
SURVEILLANCE PROGRAM
PHOENIX -- Farm Fresh Meats, Inc. and Roland Emerson Farabee, 55, of
Maricopa, Arizona, pleaded guilty to stealing $390,000 in government funds,
mail fraud and wire fraud, in federal district court in Phoenix.U.S.
Attorney Daniel Knauss stated, "The integrity of the system that tests for
mad cow disease relies upon the honest cooperation of enterprises like Farm
Fresh Meats. Without that honest cooperation, consumers both in the U.S. and
internationally are at risk. We want to thank the USDA's Office of Inspector
General for their continuing efforts to safeguard the public health and
enforce the law." Farm Fresh Meats and Farabee were charged by Information
with theft of government funds, mail fraud and wire fraud. According to the
Information, on June 7, 2004, Farabee, on behalf of Farm Fresh Meats, signed
a contract with the U.S. Department of Agriculture (the "USDA Agreement") to
collect obex samples from cattle at high risk of mad cow disease (the
"Targeted Cattle Population"). The Targeted Cattle Population consisted of
the following cattle: cattle over thirty months of age; nonambulatory
cattle; cattle exhibiting signs of central nervous system disorders; cattle
exhibiting signs of mad cow disease; and dead cattle. Pursuant to the USDA
Agreement, the USDA agreed to pay Farm Fresh Meats $150 per obex sample for
collecting obex samples from cattle within the Targeted Cattle Population,
and submitting the obex samples to a USDA laboratory for mad cow disease
testing. Farm Fresh Meats further agreed to maintain in cold storage the
sampled cattle carcasses and heads until the test results were received by
Farm Fresh Meats.
Evidence uncovered during the government's investigation established that
Farm Fresh Meats and Farabee submitted samples from cattle outside the
Targeted Cattle Population. Specifically, Farm Fresh Meats and Farabee
submitted, or caused to be submitted, obex samples from healthy, USDA
inspected cattle, in order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee
failed to maintain cattle carcasses and heads pending test results and
falsified corporate books and records to conceal their malfeasance. Such
actions, to the extent an obex sample tested positive (fortunately, none
did), could have jeopardized the USDA's ability to identify the diseased
animal and pinpoint its place of origin. On Wednesday, February 14, 2007,
Farm Fresh Meats and Farabee pleaded guilty
to stealing government funds and using the mails and wires to effect the
scheme. According to their guilty pleas:
(a) Farm Fresh Meats collected, and Farabee directed others to collect, obex
samples from cattle outside the Targeted Cattle Population, which were not
subject to payment by the USDA;
(b) Farm Fresh Meats2 and Farabee caused to be submitted payment requests to
the USDA knowing that the requests were based on obex samples that were not
subject to payment under the USDA Agreement; (c) Farm Fresh Meats completed
and submitted, and Farabee directed others to complete and submit, BSE
Surveillance Data Collection Forms to the USDA's testing laboratory that
were false and misleading;
(d) Farm Fresh Meats completed and submitted, and Farabee directed others to
complete and submit, BSE Surveillance Submission Forms filed with the USDA
that were false and misleading;
(e) Farm Fresh Meats falsified, and Farabee directed others to falsify,
internal Farm Fresh Meats documents to conceal the fact that Farm Fresh
Meats was seeking and obtaining payment from the USDA for obex samples
obtained from cattle outside the Targeted Cattle Population; and
(f) Farm Fresh Meats failed to comply with, and Farabee directed others to
fail to comply with, the USDA Agreement by discarding cattle carcasses and
heads prior to receiving BSE test results.
A conviction for theft of government funds carries a maximum penalty of 10
years imprisonment. Mail fraud and wire fraud convictions carry a maximum
penalty of 20 years imprisonment. Convictions for the above referenced
violations also carry a maximum fine of $250,000 for individuals and
$500,000 for organizations. In determining an actual sentence, Judge Earl H.
Carroll will consult the U.S. Sentencing Guidelines, which provide
appropriate sentencing ranges. The judge, however, is not bound by those
guidelines in determining a sentence. Sentencing is set before Judge Earl H.
Carroll on May 14, 2007. The investigation in this case was conducted by
Assistant Special Agent in Charge Alejandro Quintero, United States
Department of Agriculture, Office of Inspector General. The prosecution is
being handled by Robert Long, Assistant U.S. Attorney, District of Arizona,
Phoenix.
CASE NUMBER: CR-07-00160-PHX-EHC
RELEASE NUMBER: 2007-051(Farabee)
# # #
http://www.usdoj.gov/usao/az/press_releases/2007/2007-051(Farabee).pdf
how many others were doing this ???
National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC)
Testing Summary
The BSE enhanced surveillance program involves the use of a rapid screening
test, followed by confirmatory testing for any samples that come back
"inconclusive." The weekly summary below captures all rapid tests conducted
as part of the enhanced surveillance effort. 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.
To view the IHC testing numbers from 1990 through 2004, click on the
following link:
http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html
http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
BSE test options were limited
USDA: In 9,200 cases only one type of test could be used
WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17
that its testing options for bovine spongiform encephalopathy were limited
in 9,200 cases despite its effort to expand surveillance throughout the U.S.
herd.
In those cases, only one type of test was used--one that failed to detect
the disease in an infected Texas cow.
The department posted the information on its website because of an inquiry
from The Associated Press.
Conducted over the past 14 months, the tests have not been included in the
department's running tally of BSE tests since last summer. That total
reached 439,126 on Aug. 17.
"There's no secret program," the department's chief veterinarian, John
Clifford, said in an interview. "There has been no hiding, I can assure you
of that."
Officials intended to report the tests later in an annual report, Clifford
said.
These 9,200 cases were different because brain tissue samples were preserved
with formalin, which makes them suitable for only one type of
test--immunohistochemistry, or IHC.
In the Texas case, officials had declared the cow free of disease in
November after an IHC test came back negative. The department's inspector
general ordered an additional kind of test, which confirmed the animal was
infected.
Veterinarians in remote locations have used the preservative on tissue to
keep it from degrading on its way to the department's laboratory in Ames,
Iowa. Officials this year asked veterinarians to stop using preservative and
send fresh or chilled samples within 48 hours.
The department recently investigated a possible case of BSE that turned up
in a preserved sample. Further testing ruled out the disease two weeks ago.
Scientists used two additional tests--rapid screening and Western blot--to
help detect BSE in the country's second confirmed case, in a Texas cow in
June. They used IHC and Western blot to confirm the first case, in a
Washington state cow in December 2003.
"The IHC test is still an excellent test," Clifford said. "These are not
simple tests, either."
Clifford pointed out that scientists reran the IHC several times and got
conflicting results. That happened, too, with the Western blot test. Both
tests are accepted by international animal health officials.
Date: 8/25/05
http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm
> -------- Original Message --------
> Subject: USA BIO-RADs INCONCLUSIVEs
> Date: Fri, 17 Dec 2004 15:37:28 -0600
> From: "Terry S. Singeltary Sr."
> To: [email protected]
>
>
>
> Hello Susan and Bio-Rad,
>
> Happy Holidays!
>
> I wish to ask a question about Bio-Rad and USDA BSE/TSE testing
> and there inconclusive. IS the Bio-Rad test for BSE/TSE that complicated,
> or is there most likely some human error we are seeing here?
>
> HOW can Japan have 2 positive cows with
> No clinical signs WB+, IHC-, HP- ,
> BUT in the USA, these cows are considered 'negative'?
>
> IS there more politics working here than science in the USA?
>
> What am I missing?
>
>
>
> -------- Original Message --------
> Subject: Re: USDA: More mad cow testing will demonstrate beef's safety
> Date: Fri, 17 Dec 2004 09:26:19 -0600
> From: "Terry S. Singeltary Sr."
> snip...end
>
>
> Experts doubt USDA's mad cow results
snip...END
WELL, someone did call me from Bio-Rad about this,
however it was not Susan Berg.
but i had to just about take a blood oath not to reveal
there name. IN fact they did not want me to even mention
this, but i feel it is much much to important. I have omitted
any I.D. of this person, but thought I must document this ;
Bio-Rad, TSS phone conversation 12/28/04
Finally spoke with ;
Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: XXXXXXXXXXXXXXXXXX
at approx. 14:00 hours 12/28/04, I had a very pleasant
phone conversation with XXXX XXXXX about the USDA
and the inconclusive BSE testing problems they seem
to keep having. X was very very cautious as to speak
directly about USDA and it's policy of not using WB.
X was very concerned as a Bio-Rad official of retaliation
of some sort. X would only speak of what other countries
do, and that i should take that as an answer. I told X
I understood that it was a very loaded question and X
agreed several times over and even said a political one.
my question;
Does Bio-Rad believe USDA's final determination of False positive,
without WB, and considering the new
atypical TSEs not showing positive with -IHC and -HP ???
ask if i was a reporter. i said no, i was with CJD Watch
and that i had lost my mother to hvCJD. X did not
want any of this recorded or repeated.
again, very nervous, will not answer directly about USDA for fear of
retaliation, but again said X tell
me what other countries are doing and finding, and that
i should take it from there.
"very difficult to answer"
"very political"
"very loaded question"
outside USA and Canada, they use many different confirmatory tech. in
house WB, SAF, along with
IHC, HP, several times etc. you should see at several
talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS
NEGATIVE. again, look what
the rest of the world is doing.
said something about Dr. Houston stating;
any screening assay, always a chance for human
error. but with so many errors (i am assuming
X meant inconclusive), why are there no investigations, just false
positives?
said something about ''just look at the sheep that tested IHC- but were
positive''. ...
TSS
-------- Original Message --------
Subject: Your questions
Date: Mon, 27 Dec 2004 15:58:11 -0800
From: To: [email protected]
Hi Terry:
............................................snip Let me know your phone
number so I can talk to you about the Bio-Rad BSE test.
Thank you
Regards
Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: =================================
END...TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########
Executive Summary
In June 2005, an inconclusive bovine spongiform encephalopathy (BSE) sample
from November 2004, that had originally been classified as negative on the
immunohistochemistry test, was confirmed positive on SAF immunoblot (Western
blot). The U.S. Department of Agriculture (USDA) identified the herd of
origin for the index cow in Texas; that identification was confirmed by DNA
analysis. USDA, in close cooperation with the Texas Animal Health Commission
(TAHC), established an incident command post (ICP) and began response
activities according to USDA's BSE Response Plan of September 2004. Response
personnel removed at-risk cattle and cattle of interest (COI) from the index
herd, euthanized them, and tested them for BSE; all were negative. USDA and
the State extensively traced all at-risk cattle and COI that left the index
herd. The majority of these animals entered rendering and/or slaughter
channels well before the
investigation began. USDA's response to the Texas finding was thorough and
effective.
http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf
Report on Food & Drug Administration Dallas District Investigation of
Bovine Spongiform Encephalopathy Event in Texas 2005
Executive Summary:
On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for
Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was
that the BSE positive cow was born and raised in a herd in Texas and was
approximately 12 years old. The animal was sampled for BSE at a pet food
plant in Texas on November 15, 2004, as part of USDA's enhanced surveillance
program.
http://www.fda.gov/cvm/texasfeedrpt.htm
Texas even had a 'secret' test that showed that mad cow positive;
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.
http://www.usda.gov/documents/vs_bse_ihctestvar.pdf
48 hr BSE confirmation turnaround took 7+ months to confirm this case, so
the BSE MRR policy could be put into place. ...TSS
THIS highly suspect stumbling and staggering Texas Mad Cow got not test at
all, went straight to render ;
FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow
with central nervous system symptoms had been killed and shipped to a
processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began
an investigation. On Friday and throughout the weekend, FDA investigators
inspected the slaughterhouse, the rendering facility, the farm where the
animal came from, and the processor that initially received the cow from the
slaughterhouse.
FDA's investigation showed that the animal in question had already been
rendered into "meat and bone meal" (a type of protein animal feed). Over the
weekend FDA was able to track down all the implicated material. That
material is being held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest
because cattle with bovine spongiform encephalopathy or BSE, also known as
"mad cow disease," can exhibit such symptoms. In this case, there is no way
now to test for BSE. But even if the cow had BSE, FDA's animal feed rule
would prohibit the feeding of its rendered protein to other ruminant animals
(e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing
the firm that FDA will not object to use of this material in swine feed
only. If it is not used in swine feed, this material will be destroyed. Pigs
have been shown not to be susceptible to BSE. If the firm agrees to use the
material for swine feed only, FDA will track the material all the way
through the supply chain from the processor to the farm to ensure that the
feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein
out of animal feed for cattle and other ruminant animals. FDA established
its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that
the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not
allowed in feed for cattle or other ruminant animals. FDA's action
specifying that the material go only into swine feed means also that it will
not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely
with the U.S. Department of Agriculture on all BSE issues. The animal feed
rule provides crucial protection against the spread of BSE, but it is only
one of several such firewalls. FDA will soon be improving the animal feed
rule, to make this strong system even stronger.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
OR THE OTHER BSE INCONCLUSIVE THAT SAT ON A SHELF FOR 4 MONTHS WHILE THE
USDA BSE MRR POLICY WAS PUT IN MOTION, simply because this guy forgets to
send sample in, ooops ;
"I would note that the sample was taken in April, at which time the
protocols allowed for a preservative to be used. 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.
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml
THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF
RUMINANT PROTEIN WAS FED TO CATTLE ;
FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media:
301-827-6242
Broadcast Media:
301-827-3434
Consumer Inquiries:
888-INFO-FDA
FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
Today the Food and Drug Administration announced the results of tests
taken on feed used at a Texas feedlot
that was suspected of containing meat and bone meal from other domestic
cattle -- a violation of FDA's 1997
prohibition on using ruminant material in feed for other ruminants.
Results indicate that a very low level of
prohibited material was found in the feed fed to cattle.
FDA has determined that each animal could have consumed, at most and in
total, five-and-one-half grams -
approximately a quarter ounce -- of prohibited material. These animals
weigh approximately 600 pounds.
It is important to note that the prohibited material was domestic in
origin (therefore not likely to contain infected
material because there is no evidence of BSE in U.S. cattle), fed at a
very low level, and fed only once. The
potential risk of BSE to such cattle is therefore exceedingly low, even
if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy
Commissioner, "The challenge to regulators
and industry is to keep this disease out of the United States. One
important defense is to prohibit the use of any
ruminant animal materials in feed for other ruminant animals. Combined
with other steps, like U.S. Department
of Agriculture's (USDA) ban on the importation of live ruminant animals
from affected countries, these steps
represent a series of protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., is nonetheless
announcing that it is voluntarily purchasing all 1,222
of the animals held in Texas and mistakenly fed the animal feed
containing the prohibited material. Therefore,
meat from those animals will not enter the human food supply. FDA
believes any cattle that did not consume
feed containing the prohibited material are unaffected by this incident,
and should be handled in the beef supply
clearance process as usual.
FDA believes that Purina Mills has behaved responsibly by first
reporting the human error that resulted in the
misformulation of the animal feed supplement and then by working closely
with State and Federal authorities.
This episode indicates that the multi-layered safeguard system put into
place is essential for protecting the food
supply and that continued vigilance needs to be taken, by all concerned,
to ensure these rules are followed
routinely.
FDA will continue working with USDA as well as State and local officials
to ensure that companies and
individuals comply with all laws and regulations designed to protect the
U.S. food supply.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
From: TSS (216-119-144-34.ipset24.wt.net)
Subject: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE
STUDY)
Date: January 27, 2005 at 7:03 am PST
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley's surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
6. It also appears to me that Mr Bradley's answer (that it would take less
than say 100 grams) was probably given with the benefit of hindsight;
particularly if one
considers that later in the same answer Mr Bradley expresses his surprise
that it could take as little of 1 gram of brain to cause BSE by the oral
route
within the same species. This information did not become available until the
"attack
rate" experiment had been completed in 1995/96. This was a titration
experiment
designed to ascertain the infective dose. A range of dosages was used to
ensure that the actual result was within both a lower and an upper limit
within the
study and the designing scientists would not have expected all the dose
levels to
trigger infection. The dose ranges chosen by the most informed scientists at
that
time ranged from 1 gram to three times one hundred grams. It is clear that
the
designing scientists must have also shared Mr Bradley's surprise at the
results
because all the dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA
2007
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
Audit Report
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II
and
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat
Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle
Still Remain
Our prior report identified a number of inherent problems in identifying and
testing high-risk cattle. We reported that the challenges in identifying the
universe of high-risk cattle, as well as the need to design procedures to
obtain an appropriate representation of samples, was critical to the success
of the BSE surveillance program. The surveillance program was designed to
target nonambulatory cattle, cattle showing signs of CNS disease (including
cattle testing negative for rabies), cattle showing signs not inconsistent
with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS
condemned cattle were sampled and made a concerted effort for outreach to
obtain targeted samples, industry practices not considered in the design of
the surveillance program reduced assurance that targeted animals were tested
for BSE.
In our prior report, we recommended that APHIS work with public health and
State diagnostic laboratories to develop and test rabies-negative samples
for BSE. This target group is important for determining the prevalence of
BSE in the United States because rabies cases exhibit clinical signs not
inconsistent with BSE; a negative rabies test means the cause of the
clinical signs has not been diagnosed.
APHIS agreed with our recommendation and initiated an outreach program with
the American Association of Veterinary Laboratory Diagnosticians, as well as
State laboratories. APHIS also agreed to do ongoing monitoring to ensure
samples were obtained from this target population.
Although APHIS increased the samples tested from this target group as
compared to prior years, we found that conflicting APHIS instructions on the
ages of cattle to test resulted in inconsistencies in what samples were
submitted for BSE testing. Therefore, some laboratories did not refer their
rabies negative samples to APHIS in order to maximize the number tested for
this critical target population. In addition, APHIS did not monitor the
number of submissions of rabies negative samples for BSE testing from
specific laboratories.
According to the Procedure Manual for BSE Surveillance, dated October 2004,
the target population includes:
Central nervous system (CNS) signs and/or rabies negative - sample animals
of any age (emphasis added):
a. Diagnostic laboratories –samples submitted due to evidence of CNS
clinical signs.
Rabies Negative Samples
USDA/OIG-A/50601-10-KC Page 19 USDA/OIG-A/50601-10-KC Page 20
b. Public health laboratories – rabies negative cases.
c. Slaughter facilities – CNS ante mortem condemned at slaughter, sampled by
FSIS.
d. On-the-farm – CNS cattle that do not meet the criteria for a foreign
animal disease investigation.
For FYs 2002, 2003, and 2004 (through February 2004), NVSL received 170,
133, and 45 rabies-negative samples, respectively. Between June 1, 2004, and
May 29, 2005, the number of samples received for testing increased to 226
rabies suspect samples. The collection sites submitting these samples
follow.
Number of Rabies
Suspect Submissions *
Slaughter Plant
0
Renderer
2
On-Farm
11
Public Health Lab
94
Diagnostic Lab
81
3D-4D
8
Other
4
Collection Site
Total
200
* 26 were tested but not counted by APHIS towards meeting the target goals
because the obex was not submitted.
We obtained a copy of a memorandum, dated July 13, 2004, that APHIS sent to
diagnostic and public health laboratories providing them instructions on
submitting samples for cattle showing signs of CNS diseases, but testing
negative for rabies. The letter was sent to about 170 State veterinary
diagnostic and public health laboratories and discussed the need to submit
specimens to NVSL of all adult cattle (emphasis added) that showed signs of
CNS diseases, but tested negative for rabies. This directive did not specify
the age of the cattle. The Procedure Manual for BSE Surveillance, dated
October 2004, specified samples of cattle of any age should be submitted.
We contacted laboratories in six States to determine if it was standard
procedure to submit all negative rabies samples to NVSL. We found that,
because of the lack of specificity in the APHIS letter and inadequate
followup by APHIS, there were inconsistencies in the age of cattle samples
submitted for BSE testing. For those States contacted, the following samples
were submitted versus tested as negative for rabies.
USDA/OIG-A/50601-10-KC Page 21
Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004
State
Negative Rabies Tests
Not Sent for BSE Testing
Pennsylvania a/
15
18
Kansas b/
69
16
Wisconsin c/
1
11
South Dakota d/
0
7
Arizona e/
5
0
Mississippi e/
4
0
Total
Sent for BSE Testing
33
85
12
7
5
4
146
94
52
a/ A Pennsylvania laboratory official said only rabies negative cattle over
20 months of age were submitted for BSE testing. The laboratory did not
submit 18 samples for BSE testing because the animals were less than 20
months of age.
b/ Kansas laboratory officials said early in the expanded surveillance
program, there was confusion as to the cattle ages that should be submitted
for BSE testing. They did not know if cattle should be submitted that were
above 20 months or 30 months of age. Of the 16 animals not submitted for BSE
testing, 14 were under 20 months of age from early in the expanded
surveillance program. The other two animals were not tested due to internal
laboratory issues. The Kansas and Nebraska area office officials contacted
the laboratory and told the officials to submit rabies negative cattle of
any age for BSE testing. The laboratory now submits all rabies negative
cattle for BSE testing.
c/ A Wisconsin laboratory official said only rabies negative cattle samples
30 months of age or older are submitted for BSE testing. Of the 11 animals
not submitted for BSE testing, 8 were less than 30 months of age. Wisconsin
laboratory officials were not certain why the other three samples were not
submitted.
d/ Laboratory officials from South Dakota said they did not receive
notification from APHIS regarding the submission of rabies negative cases
for BSE testing. The section supervisor and laboratory director were not
aware of any letter sent to the laboratory. The section supervisor said most
bovine rabies tests at the laboratory are performed on calves. We confirmed
the laboratory's address matched the address on APHIS' letter distribution
list. However, there was no evidence that the South Dakota area office
contacted the laboratory. The laboratory was not listed on the documentation
from the APHIS regional office detailing the area office contacts with
laboratory personnel. We contacted the South Dakota area office and were
advised that while some contact had been made with the laboratory, the
contact may have involved Brucellosis rather than BSE. On May 4, 2005, the
area office
33 Report from the Secretary's Advisory Committee on Foreign Animal and
Poultry Diseases, February 13, 2004.
advised us they recently contacted the laboratory regarding the submission
of rabies negative samples for BSE testing.
e/ Arizona and Mississippi laboratory officials said they submitted all
rabies negative samples for BSE testing regardless of the age of the animal.
An NVSL official stated that APHIS is not concerned with rabies negatives
samples from cattle less than 30 months of age. This position, however, is
contrary to APHIS' published target population.
Our prior audit recognized the significant challenge for APHIS to obtain
samples from some high-risk populations because of the inherent problems
with obtaining voluntary compliance and transporting the carcasses for
testing. USDA issued rules to prohibit nonambulatory animals (downers) from
entering the food supply at inspected slaughterhouses. OIG recommended, and
the International Review Subcommittee33 emphasized, that USDA should take
additional steps to assure that facilitated pathways exist for dead and
nonambulatory cattle to allow for the collection of samples and proper
disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS
database documents 27,617 samples were collected showing a reason for
submission of nonambulatory and 325,225 samples were collected with reason
of submission showing "dead."
APHIS made extensive outreach efforts to notify producers and private
veterinarians of the need to submit and have tested animals from these
target groups. They also entered into financial arrangements with 123
renderers and other collection sites to reimburse them for costs associated
with storing, transporting, and collecting samples. However, as shown in
exhibit F, APHIS was not always successful in establishing agreements with
non-slaughter collection sites in some States. APHIS stated that agreements
do not necessarily reflect the entire universe of collection sites and that
the presentation in exhibit F was incomplete because there were many
collection sites without a payment involved or without a formal agreement.
We note that over 90 percent of the samples collected were obtained from the
123 collection sites with agreements and; therefore, we believe agreements
offer the best source to increase targeted samples in underrepresented
areas.
We found that APHIS did not consider industry practices in the design of its
surveillance effort to provide reasonable assurance that cattle exhibiting
possible clinical signs consistent with BSE were tested. Slaughter
facilities do not always accept all cattle arriving for slaughter because of
their business requirements. We found that, in one State visited, slaughter
facilities pre-screened and rejected cattle (sick/down/dead/others not
meeting business
Downers and Cattle that Died on the Farm
USDA/OIG-A/50601-10-KC Page 22 USDA/OIG-A/50601-10-KC Page 23
34 FSIS regulations do not specifically address the designation of an
establishment's "official" boundaries; however, FSIS Notices 29-04 (dated
May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS
inspection staff are not responsible for sampling dead cattle that are not
part of the "official" premises.
35 APHIS' area office personnel stated that it was their understanding that
some establishments in the State were not presenting cattle that died or
were down on the transport vehicle to FSIS for ante mortem inspection. The
dead and down cattle were left in the vehicle, if possible. In rare
circumstances, dead cattle may be removed from the trailer by plant
personnel to facilitate the unloading of other animals.
36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.
standards) before presentation for slaughter in areas immediately adjacent
or contiguous to the official slaughter establishment. These animals were
not inspected and/or observed by either FSIS or APHIS officials located at
the slaughter facilities.
FSIS procedures state that they have no authority to inspect cattle not
presented for slaughter. Further, APHIS officials stated they did not
believe that they had the authority to go into these sorting and/or
screening areas and require that the rejected animals be provided to APHIS
for BSE sampling. Neither APHIS nor FSIS had any process to assure that
animals left on transport vehicles and/or rejected for slaughter arrived at
a collection site for BSE testing. FSIS allows slaughter facilities to
designate the area of their establishment where federal inspection is
performed; this is designated as the official slaughter establishment.34
We observed animals that were down or dead in pens outside the official
premises that were to be picked up by renderers. Animals that were rejected
by plant personnel were transported off the premises on the same vehicles
that brought them to the plant.35
A policy statement36 regarding BSE sampling of condemned cattle at slaughter
plants provided that effective June 1, 2004, FSIS would collect BSE samples
for testing: 1) from all cattle regardless of age condemned by FSIS upon
ante mortem inspection for CNS impairment, and 2) from all cattle, with the
exception of veal calves, condemned by FSIS upon ante mortem inspection for
any other reason.
FSIS Notice 28-04, dated May 20, 2004, informed FSIS personnel that, "FSIS
will be collecting brain samples from cattle at federally-inspected
establishments for the purpose of BSE testing." The notice further states
that, "Cattle off-loaded from the transport vehicle onto the premises of the
federally-inspected establishment (emphasis added), whether dead or alive,
will be sampled by the FSIS Public Health Veterinarian (PHV) for BSE after
the cattle have been condemned during ante mortem inspection. In addition,
cattle passing ante mortem inspection but later found dead prior to
slaughter will be condemned and be sampled by the FSIS PHV."
USDA/OIG-A/50601-10-KC Page 24
37 FSIS Notice 40-04, dated July 29, 2004.
38 FSIS Notice 29-04, dated May 27, 2004.
APHIS has the responsibility for sampling dead cattle off-loaded onto
plant-owned property that is adjoining to, but not considered part of, the
"official premises.37 FSIS procedures38 provide that "Dead cattle that are
off-loaded to facilitate the off-loading of live animals, but that will be
re-loaded onto the transport vehicle, are not subject to sampling by FSIS.
While performing our review in one State, we reviewed the circumstances at
two slaughter facilities in the State that inspected and rejected unsuitable
cattle before the animals entered the official receiving areas of the
plants. This pre-screening activity was conducted in areas not designated by
the facility as official premises of the establishment and not under the
review or supervision of FSIS inspectors. The plant rejected all
nonambulatory and dead/dying/sick animals delivered to the establishment.
Plant personnel refused to offload any dead or downer animals to facilitate
the offloading of ambulatory animals. Plant personnel said that the driver
was responsible for ensuring nonambulatory animals were humanely euthanized
and disposing of the carcasses of the dead animals. Plant personnel informed
us that they did not want to jeopardize contracts with business partners by
allowing unsuitable animals on their slaughter premises.
In the second case, one family member owned a slaughter facility while
another operated a livestock sale barn adjacent to the slaughter facility.
The slaughter facility was under FSIS' supervision while the sale barn was
not. Cattle sometimes arrived at the sale barn that were sick/down/dead or
would die or go down while at the sale barn. According to personnel at the
sale barn, these animals were left for the renderer to collect. The healthy
ambulatory animals that remained were marketed to many buyers including the
adjacent slaughter facility. When the slaughter facility was ready to accept
the ambulatory animals for processing, the cattle would be moved from the
sale barn to the slaughter facility where they were subject to FSIS'
inspection.
We requested the slaughter facilities to estimate the number of cattle
rejected on a daily basis (there were no records to confirm the estimates).
We visited a renderer in the area and found that the renderer had a contract
with APHIS to collect samples for BSE testing. In this case, although we
could not obtain assurance that all rejected cattle were sampled, the
renderer processed a significant number of animals, as compared to the
slaughter plants' estimates of those rejected. Due to the close proximity
(less than 5 miles) of the renderer to the slaughter facilities, and the
premium it paid for dead cattle that were in good condition, there was a
financial incentive for transport drivers to dispose of their dead animals
at this renderer.
USDA/OIG-A/50601-10-KC Page 25
In our discussions with APHIS officials in Wisconsin and Iowa, they
confirmed that there were plants in their States that also used
pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to
provide a list of all slaughter facilities that pre-screened cattle for
slaughter in locations away from the area designated as the official
slaughter facility. Along with this request, we asked for information to
demonstrate that either APHIS or FSIS confirmed there was a high likelihood
that high-risk animals were sampled at other collection sites.
In response to our request, the APHIS BSE Program Manager stated that APHIS
did not have information on slaughter plants that pre-screen or screen their
animals for slaughter suitability off their official plant premises. To
their knowledge, every company or producer that submits animals for
slaughter pre-sorts or screens them for suitability at various locations
away from the slaughter facility. For this reason, USDA focused its BSE
sample collection efforts at other types of facilities such as renderers,
pet food companies, landfills, and dead stock haulers. Further, in a letter
to OIG on June 14, 2005, the administrators of APHIS and FSIS noted the
following:
"…we believe that no specific actions are necessary or appropriate to obtain
reasonable assurance that animals not presented for slaughter are being
tested for BSE. There are several reasons for our position. First, we do not
believe that the practice is in fact causing us to not test a significant
enough number of animals in our enhanced surveillance program to invalidate
the overall results. Second, OIG has concluded that because of the
geographical proximity and business relationships of the various entities
involved in the case investigated, there is reasonable assurance that a
majority of the rejected cattle had been sampled. Third, it is also
important to remember that the goal of the enhanced surveillance program is
to test a sufficient number of animals to allow us to draw conclusions about
the level of BSE (if any) in the American herd…We believe that the number we
may be not testing because of the "pre-sorting" practice does not rise to a
significant level. The number of animals tested to date has far exceeded
expectations, so it is reasonable to infer that there are few of the animals
in question, or that we are testing them at some other point in the
process…APHIS estimated…there were approximately 446,000 high risk
cattle…[and APHIS has]…tested over 375,000 animals in less than 1 year. This
indicated that we are missing few animals in the high-risk population,
including those that might be pre-sorted before entering a slaughter
facility's property."
We obtained 123 APHIS sampling agreements and contracts with firms and
plotted their locations within the United States (see exhibit F). We also
analyzed the samples tested to the BSE sampling goals allocated to each
State under the prior surveillance program. This analysis showed that there
are
USDA/OIG-A/50601-10-KC Page 26
39APHIS noted that sites with agreements do not necessarily reflect the
entire universe of collection sites and at some sites APHIS collects samples
with no payment involved and no agreement in place. OIG agrees that not all
collection sites are reflected in our presentation of the 123 sites with
reimbursable agreements. OIG believes obtaining sampling agreements is one
of the primary methods available to increase sample numbers in areas with
sampling gaps.
sampling gaps in two large areas of the United States where APHIS did not
have contracts with collection sites. These two areas are shown in the
following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1
and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2):
State
Original Sampling Goal Based on (268,500 sampling goal)
Samples collected as of May 31, 2005
No. of BSE Sampling Agreements/
Contracts39
snip...see chart in pdf full text link. ...tss
APHIS notes that for the current surveillance program, it had established
regional goals and APHIS was not trying to meet particular sampling levels
in particular States. However, we believe that it would be advantageous for
APHIS to monitor collection data and increase outreach when large
geographical areas such as the above States do not provide samples in
proportion to the numbers and types of cattle in the population.
We also disagree with APHIS/FSIS' contention that because they have tested
over 375,000 of their 446,000 estimate of high risk cattle, few in the
high-risk population are being missed, including those that might be
pre-screened before entering a slaughter facility's property. In our prior
audit, we reported that APHIS underestimated the high-risk population; we
found that this estimate should have been closer to 1 million animals (see
Finding 1). We recognize that BSE samples are provided on a voluntary basis;
however, APHIS should consider industry practice in any further maintenance
surveillance effort. Animals unsuitable for slaughter exhibiting symptoms
not inconsistent with BSE should be sampled and their clinical signs
recorded. However, this cited industry practice results in rejected animals
not being made available to either APHIS or FSIS veterinarians for their
observation and identification of clinical signs exhibited ante mortem.
Although these animals may be sampled later at other collection sites, the
animals are provided post mortem without information as to relevant clinical
signs exhibited ante mortem. For these reasons, we believe APHIS needs to
USDA/OIG-A/50601-10-KC Page 27
observe these animals ante mortem when possible to assure the animals from
the target population are ultimately sampled and the clinical signs
evaluated.
snip...
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 infect
cattle dealers i.e. USDA
Date: May 14, 2007 at 9:00 am PST
OIE BSE RECOMMENDATION FOR USA, bought and paid for by your local cattle
dealers i.e. USDA
STATEMENT BY DR. RON DEHAVEN REGARDING OIE RISK RECOMMENDATION
March 9, 2007
"In October 2006, the U.S. Department of Agriculture submitted an
application and supporting documents to the World Organization for Animal
Health (OIE) to formally request country classification for bovine
spongiform encephalopathy (BSE) risk. The OIE undertakes a thorough review
process before recommending a risk classification, and then provides an
opportunity for all delegate countries to review the recommendations and
present comments prior to final adoption of a country's classification at
the OIE's General Assembly meeting in May.
"While we recognize that a final classification decision will not be made by
the OIE until May, we feel it is important to be responsive to questions we
are now being asked about the risk classification recommended for the United
States. The OIE Scientific Commission has endorsed the recommendation from
an OIE expert panel that the United States be classified as "controlled
risk" for BSE.
"The controlled risk classification recognizes that OIE-recommended,
science-based mitigation measures are in place to effectively manage any
possible risk of BSE in the cattle population. This recommendation provides
strong support that U.S. regulatory controls are effective and that U.S
cattle and products from cattle of all ages can be safely traded in
accordance with international guidelines, due to our interlocking
safeguards.
"The OIE risk classification process is an essential step in promoting trade
and understanding of this disease. We appreciate OIE's review of our
application, as well as its leadership in developing sound, science-based
guidelines that will help countries standardize regulations and import
requirements. We look forward to the final adoption of this classification,
which will be announced at the OIE meeting in May."
#
http://www.aphis.usda.gov/newsroom/content/2007/03/OIE_statement3-9-07.shtml
Sample Size Estimate for BSE Ongoing Surveillance
July 20, 2006
Purpose, rationale, and objectives of surveillance
Animal and public health concerns about bovine spongiform encephalopathy
(BSE) have led to the establishment of active surveillance programs among
other
regulatory measures to monitor and prevent disease. Active surveillance for
BSE was initiated in the United States in 1990. In response to
identification of a BSE-affected imported dairy cow in December 2003, the
U.S. Enhanced BSE Surveillance Program was implemented in June 2004. Through
these efforts, two cases of BSE were identified through March 2006. Both
cases were in beef cattle over 10 years old (born before the feed ban of
1997), one located in Texas and one in Alabama.
Based on data collected in the United States over the last 7 years,
including over a half million samples from the Enhanced Surveillance
program, the USDA has
developed an estimate of prevalence of BSE among U.S. cattle that was
extremely low, projected at less than one case per million animals in the
standing adult cattle population at the 95 percent confidence level (APHIS
2006a). In addition, the USDA demonstrated that surveillance efforts to date
far exceed the World Organization for Animal Health (OIE) "type A"
surveillance recommendations. Prevalence is expected to decline as long as
mitigation efforts that maintain low risk for introduction and spread of the
BSE agent among U.S. cattle are equivalent to or better than those evaluated
by the Harvard Risk Assessment (Cohen et al., 2001, 2003).
The principal purposes of ongoing BSE surveillance are:
1. To continue to monitor the BSE status of U.S. cattle.
2. To provide mechanisms for detection of BSE prevalence if it were to
increase above 1 infected animal per million adults.
In addition, we aim to meet the objective of conducting ongoing surveillance
at a level that meets or exceeds OIE surveillance recommendations. We
believe this
objective is reached by the following sampling strategy, which is sufficient
to detect BSE at 1 infected animal per 1,000,000 adult cattle in the
population with a high
degree of confidence.
Sample Size to Meet OIE Surveillance Recommendations
APHIS is committed to maintaining BSE surveillance that at least meets OIE
guidelines. The OIE surveillance guidelines for BSE recommend a target
number of
surveillance points for Type A surveillance based on the size of a country's
cattle population. These points are accrued over 7 consecutive years, and
are weighted according to the surveillance stream and age of the animal
sampled. For a large cattle population, using the design prevalence of 1
case per 100,000 adult cattle and 95 percent confidence, 300,000 total
points over 7 years, or 42,857 points per year, are required for Type A
surveillance (OIE 2005).
The four surveillance streams identified in the OIE Code are clinical
suspects; casualty slaughter; fallen stock; and healthy slaughter. OIE
guidelines recommend
sampling from at least three of the four surveillance streams. BSE
surveillance efforts in the United States have always focused on the three
surveillance streams where BSE is more likely to be found – clinical
suspects, casualty slaughter, and fallen stock. During the 7 consecutive
years prior to March 17, 2006, the United States collected 735,213 BSE
samples from these surveillance streams and accumulated 2,973,804 OIE points
(APHIS 2006b).
As shown in the calculation below, if the ongoing surveillance plan
continues similar sample numbers from these surveillance streams,
approximately 10,500 cattle
per year would be sufficient to meet the OIE minimum number of sample points
for Type A surveillance.
2,973,804 points ÷ 735,213 samples = 4.1 points per sample and 42,857 points
required per year ÷ 4.1 points per sample = 10,453 samples per year
Sample Size for BSE Prevalence Estimates
The OIE minimum number of samples as outlined would be sufficient for a
design prevalence of 1 case per 100,000 adult cattle. However, in the
interest of
maintaining confidence in previous BSE prevalence estimates, a more
sensitive design prevalence of 1 case per 1 million adult cattle will be
adopted for ongoing surveillance. The BSurvE model (Wilesmith et al., 2004)
can be used to help estimate the number of samples necessary to achieve this
level of detection. This model determines sample point values based on a
particular population's demographics.
The point tables described by OIE surveillance guidelines were designed
using the BSurvE model to represent a conservative scenario (e.g., low point
value and
greater number of samples) of the characteristics of the cattle populations
of all of its member countries. These demographic characteristics describe a
hypothetic
population that culls cattle very rapidly (mean age of approximately 4
years) and results in point values that are lower than the BSurvE model
would calculate for cattle in most countries. In the United States, however,
demographic data indicate 25 percent of the adult cattle population of
approximately 42 million are dairy production type and 75% are percent beef
cattle (NASS 2005). While the U.S. dairy population undergoes rapid culling
similar to the characteristics used to develop the OIE table, beef cattle
generally remain in the herd to a much older age until they no longer
produce calves. Because actual U.S. data are available regarding population
characteristics, it is appropriate to base the sample size estimates on the
points calculated through BSurvE given U.S. demographics (these points are
hereafter referred to as "analytical points"). The higher average age at
which beef cattle are culled influences the BSurvE output and results in
substantially higher point values. Hence, sample values calculated with
BSurvE from actual U.S. data result in higher point values than the
conservative OIE estimates. Each analytical point calculated by BSurvE
corresponds to a single nontargeted sample (Wilesmith et al., 2004).
According to OIE, BSurvE and Cannon and Roe (1982) calculations, the
required number of non-targeted samples needed to detect a prevalence of 1
case per million adult cattle with 95% confidence (given a population size
of 42 million adult cattle) is 3,000,000, 2,995,730, and 2,891,389,
respectively. Conservatively using the value of 3 million, we calculate that
we will need to accumulate 428,571 analytical points (with negative results)
per year across a period of 7 years to meet this objective. 3,000,000
analytical points ÷ 7 years = 428,571 analytical points per year The
prevalence analysis conducted on U.S. surveillance data collected from
March, 1999 through March 2006 reports 6,745,010 points resulting from
735,213 samples. The average sample was worth 9.5 analytical points.1
6,745,010 analytic points ÷ 735,213 samples = 9.5 analytic points per sample
If USDA maintained an equivalent mix of surveillance streams during ongoing
surveillance, then approximately 45,113 samples per year would be required
to meet this objective. 428,571 analytical points per year ÷ 9.5 analytical
points per sample = 45,113 samples per year However, greater than one half
million of the samples from Enhanced Surveillance were collected from fallen
stock – the surveillance stream that produced the lowest point values.
Sampling efforts can be focused on higher value surveillance streams –
clinical suspects and casualty slaughter – with a limited number of samples
obtained from the fallen stock surveillance stream. This will substantially
increase the average point value per sample. Therefore, we estimate that
40,000 samples collected from these three surveillance streams – with a
focus on clinical suspects and casualty slaughter - will
exceed the number of points necessary to maintain confidence that prevalence
is less than one infected animal per million adult cattle. Further, since
the data are
analyzed over 7 consecutive years, the estimate of sample size may be
adjusted each year as appropriate to assure a robust prevalence estimate.
References:
APHIS (Animal and Plant Health Inspection Service) (2006a). An Estimate of
the Prevalence of BSE
in the United States. USDA: APHIS: VS: Centers for Epidemiology and Animal
Health, National
Surveillance Unit. Accessed May 5, 2006, online at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/BSEprevalenceestimate4-
26-06.pdf
APHIS (Animal and Plant Health Inspection Service) (2006b). Summary of BSE
Enhanced
Surveillance in the United States. USDA: APHIS: VS: Centers for Epidemiology
and Animal Health,
National Surveillance Unit. Accessed May 5, 2006, online at
http://www.aphis.usda.gov/newsroom/hot_issues/bse/content/printable_version/SummaryEnhancedBS
E-Surv4-26-06.pdf
Cannon RM, Roe RT (1982). Livestock Disease Surveys: A Field Manual for
Veterinarians, Australian
Bureau of Animal Health, Canberra.
Cohen JT, Duggar K, Gray G, Kreindel S, Abdelrahman H, HabteMariam T, Oryang
D, Tameru B
(2001, 2003). Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States.
Harvard Center for Risk Analysis/Harvard School of Public Health and Center
for Computational
Epidemiology, College of Veterinary Medicine, Tuskegee University. November
2001, (revised
October 2003). Available at
http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf.
NASS (2005) Cattle, National Agricultural Statistics Service, USDA.
Washington, D.C. Released
January 28, 2005, by the National Agricultural Statistics Service (NASS),
Agricultural Statistics
Board, U.S. Department of Agriculture. Available December 15, 2005, at:
http://usda.mannlib.cornell.edu/reports/nassr/livestock/pct-bb/catl0101.txt
OIE (Office International des Epizooties) (2005). Appendix 3.8.4:
Surveillance for bovine spongiform
encephalopathy. In: Terrestrial animal health code, 14th ed., Paris, 2005.
Wilesmith J, Morris R, Stevenson M, Cannon R, Prattley D, and Benard H
(2004). Development of a
Method for the Evaluation of National Surveillance Data and Optimization of
National Surveillance
Strategies for Bovine Spongiform Encephalopathy. European Union TSE
Community Reference
Laboratory, Veterinary Laboratories Agency, Weybridge, England.
http://www.aphis.usda.gov/peer_review/downloads/BSE_sample_size_ongoing_surv_after.pdf
does not compute. fuzzy math. full formula below. ...TSS
-MORE
Office of the United States Attorney
District of Arizona
FOR IMMEDIATE RELEASE For Information Contact Public Affairs
February 16, 2007 WYN HORNBUCKLE
Telephone: (602) 514-7625
Cell: (602) 525-2681
CORPORATION AND ITS PRESIDENT PLEAD GUILTY
TO DEFRAUDING GOVERNMENT'S MAD COW DISEASE
SURVEILLANCE PROGRAM
PHOENIX -- Farm Fresh Meats, Inc. and Roland Emerson Farabee, 55, of
Maricopa, Arizona, pleaded guilty to stealing $390,000 in government funds,
mail fraud and wire fraud, in federal district court in Phoenix.U.S.
Attorney Daniel Knauss stated, "The integrity of the system that tests for
mad cow disease relies upon the honest cooperation of enterprises like Farm
Fresh Meats. Without that honest cooperation, consumers both in the U.S. and
internationally are at risk. We want to thank the USDA's Office of Inspector
General for their continuing efforts to safeguard the public health and
enforce the law." Farm Fresh Meats and Farabee were charged by Information
with theft of government funds, mail fraud and wire fraud. According to the
Information, on June 7, 2004, Farabee, on behalf of Farm Fresh Meats, signed
a contract with the U.S. Department of Agriculture (the "USDA Agreement") to
collect obex samples from cattle at high risk of mad cow disease (the
"Targeted Cattle Population"). The Targeted Cattle Population consisted of
the following cattle: cattle over thirty months of age; nonambulatory
cattle; cattle exhibiting signs of central nervous system disorders; cattle
exhibiting signs of mad cow disease; and dead cattle. Pursuant to the USDA
Agreement, the USDA agreed to pay Farm Fresh Meats $150 per obex sample for
collecting obex samples from cattle within the Targeted Cattle Population,
and submitting the obex samples to a USDA laboratory for mad cow disease
testing. Farm Fresh Meats further agreed to maintain in cold storage the
sampled cattle carcasses and heads until the test results were received by
Farm Fresh Meats.
Evidence uncovered during the government's investigation established that
Farm Fresh Meats and Farabee submitted samples from cattle outside the
Targeted Cattle Population. Specifically, Farm Fresh Meats and Farabee
submitted, or caused to be submitted, obex samples from healthy, USDA
inspected cattle, in order to steal government moneys.
Evidence collected also demonstrated that Farm Fresh Meats and Farabee
failed to maintain cattle carcasses and heads pending test results and
falsified corporate books and records to conceal their malfeasance. Such
actions, to the extent an obex sample tested positive (fortunately, none
did), could have jeopardized the USDA's ability to identify the diseased
animal and pinpoint its place of origin. On Wednesday, February 14, 2007,
Farm Fresh Meats and Farabee pleaded guilty
to stealing government funds and using the mails and wires to effect the
scheme. According to their guilty pleas:
(a) Farm Fresh Meats collected, and Farabee directed others to collect, obex
samples from cattle outside the Targeted Cattle Population, which were not
subject to payment by the USDA;
(b) Farm Fresh Meats2 and Farabee caused to be submitted payment requests to
the USDA knowing that the requests were based on obex samples that were not
subject to payment under the USDA Agreement; (c) Farm Fresh Meats completed
and submitted, and Farabee directed others to complete and submit, BSE
Surveillance Data Collection Forms to the USDA's testing laboratory that
were false and misleading;
(d) Farm Fresh Meats completed and submitted, and Farabee directed others to
complete and submit, BSE Surveillance Submission Forms filed with the USDA
that were false and misleading;
(e) Farm Fresh Meats falsified, and Farabee directed others to falsify,
internal Farm Fresh Meats documents to conceal the fact that Farm Fresh
Meats was seeking and obtaining payment from the USDA for obex samples
obtained from cattle outside the Targeted Cattle Population; and
(f) Farm Fresh Meats failed to comply with, and Farabee directed others to
fail to comply with, the USDA Agreement by discarding cattle carcasses and
heads prior to receiving BSE test results.
A conviction for theft of government funds carries a maximum penalty of 10
years imprisonment. Mail fraud and wire fraud convictions carry a maximum
penalty of 20 years imprisonment. Convictions for the above referenced
violations also carry a maximum fine of $250,000 for individuals and
$500,000 for organizations. In determining an actual sentence, Judge Earl H.
Carroll will consult the U.S. Sentencing Guidelines, which provide
appropriate sentencing ranges. The judge, however, is not bound by those
guidelines in determining a sentence. Sentencing is set before Judge Earl H.
Carroll on May 14, 2007. The investigation in this case was conducted by
Assistant Special Agent in Charge Alejandro Quintero, United States
Department of Agriculture, Office of Inspector General. The prosecution is
being handled by Robert Long, Assistant U.S. Attorney, District of Arizona,
Phoenix.
CASE NUMBER: CR-07-00160-PHX-EHC
RELEASE NUMBER: 2007-051(Farabee)
# # #
http://www.usdoj.gov/usao/az/press_releases/2007/2007-051(Farabee).pdf
how many others were doing this ???
National Veterinary Services Laboratory (NVSL) Immunohistochemistry (IHC)
Testing Summary
The BSE enhanced surveillance program involves the use of a rapid screening
test, followed by confirmatory testing for any samples that come back
"inconclusive." The weekly summary below captures all rapid tests conducted
as part of the enhanced surveillance effort. 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.
To view the IHC testing numbers from 1990 through 2004, click on the
following link:
http://www.aphis.usda.gov/lpa/issues/bse/surveillance/figure2f.html
http://www.aphis.usda.gov/lpa/issues/bse_testing/test_results.html
BSE test options were limited
USDA: In 9,200 cases only one type of test could be used
WASHINGTON (AP)--The U.S. Department of Agriculture acknowledged Aug. 17
that its testing options for bovine spongiform encephalopathy were limited
in 9,200 cases despite its effort to expand surveillance throughout the U.S.
herd.
In those cases, only one type of test was used--one that failed to detect
the disease in an infected Texas cow.
The department posted the information on its website because of an inquiry
from The Associated Press.
Conducted over the past 14 months, the tests have not been included in the
department's running tally of BSE tests since last summer. That total
reached 439,126 on Aug. 17.
"There's no secret program," the department's chief veterinarian, John
Clifford, said in an interview. "There has been no hiding, I can assure you
of that."
Officials intended to report the tests later in an annual report, Clifford
said.
These 9,200 cases were different because brain tissue samples were preserved
with formalin, which makes them suitable for only one type of
test--immunohistochemistry, or IHC.
In the Texas case, officials had declared the cow free of disease in
November after an IHC test came back negative. The department's inspector
general ordered an additional kind of test, which confirmed the animal was
infected.
Veterinarians in remote locations have used the preservative on tissue to
keep it from degrading on its way to the department's laboratory in Ames,
Iowa. Officials this year asked veterinarians to stop using preservative and
send fresh or chilled samples within 48 hours.
The department recently investigated a possible case of BSE that turned up
in a preserved sample. Further testing ruled out the disease two weeks ago.
Scientists used two additional tests--rapid screening and Western blot--to
help detect BSE in the country's second confirmed case, in a Texas cow in
June. They used IHC and Western blot to confirm the first case, in a
Washington state cow in December 2003.
"The IHC test is still an excellent test," Clifford said. "These are not
simple tests, either."
Clifford pointed out that scientists reran the IHC several times and got
conflicting results. That happened, too, with the Western blot test. Both
tests are accepted by international animal health officials.
Date: 8/25/05
http://www.hpj.com/archives/2005/aug05/aug29/BSEtestoptionswerelimited.cfm
> -------- Original Message --------
> Subject: USA BIO-RADs INCONCLUSIVEs
> Date: Fri, 17 Dec 2004 15:37:28 -0600
> From: "Terry S. Singeltary Sr."
> To: [email protected]
>
>
>
> Hello Susan and Bio-Rad,
>
> Happy Holidays!
>
> I wish to ask a question about Bio-Rad and USDA BSE/TSE testing
> and there inconclusive. IS the Bio-Rad test for BSE/TSE that complicated,
> or is there most likely some human error we are seeing here?
>
> HOW can Japan have 2 positive cows with
> No clinical signs WB+, IHC-, HP- ,
> BUT in the USA, these cows are considered 'negative'?
>
> IS there more politics working here than science in the USA?
>
> What am I missing?
>
>
>
> -------- Original Message --------
> Subject: Re: USDA: More mad cow testing will demonstrate beef's safety
> Date: Fri, 17 Dec 2004 09:26:19 -0600
> From: "Terry S. Singeltary Sr."
> snip...end
>
>
> Experts doubt USDA's mad cow results
snip...END
WELL, someone did call me from Bio-Rad about this,
however it was not Susan Berg.
but i had to just about take a blood oath not to reveal
there name. IN fact they did not want me to even mention
this, but i feel it is much much to important. I have omitted
any I.D. of this person, but thought I must document this ;
Bio-Rad, TSS phone conversation 12/28/04
Finally spoke with ;
Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: XXXXXXXXXXXXXXXXXX
at approx. 14:00 hours 12/28/04, I had a very pleasant
phone conversation with XXXX XXXXX about the USDA
and the inconclusive BSE testing problems they seem
to keep having. X was very very cautious as to speak
directly about USDA and it's policy of not using WB.
X was very concerned as a Bio-Rad official of retaliation
of some sort. X would only speak of what other countries
do, and that i should take that as an answer. I told X
I understood that it was a very loaded question and X
agreed several times over and even said a political one.
my question;
Does Bio-Rad believe USDA's final determination of False positive,
without WB, and considering the new
atypical TSEs not showing positive with -IHC and -HP ???
ask if i was a reporter. i said no, i was with CJD Watch
and that i had lost my mother to hvCJD. X did not
want any of this recorded or repeated.
again, very nervous, will not answer directly about USDA for fear of
retaliation, but again said X tell
me what other countries are doing and finding, and that
i should take it from there.
"very difficult to answer"
"very political"
"very loaded question"
outside USA and Canada, they use many different confirmatory tech. in
house WB, SAF, along with
IHC, HP, several times etc. you should see at several
talks meetings (TSE) of late Paris Dec 2, that IHC- DOES NOT MEAN IT IS
NEGATIVE. again, look what
the rest of the world is doing.
said something about Dr. Houston stating;
any screening assay, always a chance for human
error. but with so many errors (i am assuming
X meant inconclusive), why are there no investigations, just false
positives?
said something about ''just look at the sheep that tested IHC- but were
positive''. ...
TSS
-------- Original Message --------
Subject: Your questions
Date: Mon, 27 Dec 2004 15:58:11 -0800
From: To: [email protected]
Hi Terry:
............................................snip Let me know your phone
number so I can talk to you about the Bio-Rad BSE test.
Thank you
Regards
Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: =================================
END...TSS
######### https://listserv.kaliv.uni-karlsruhe.de/warc/bse-l.html ##########
Executive Summary
In June 2005, an inconclusive bovine spongiform encephalopathy (BSE) sample
from November 2004, that had originally been classified as negative on the
immunohistochemistry test, was confirmed positive on SAF immunoblot (Western
blot). The U.S. Department of Agriculture (USDA) identified the herd of
origin for the index cow in Texas; that identification was confirmed by DNA
analysis. USDA, in close cooperation with the Texas Animal Health Commission
(TAHC), established an incident command post (ICP) and began response
activities according to USDA's BSE Response Plan of September 2004. Response
personnel removed at-risk cattle and cattle of interest (COI) from the index
herd, euthanized them, and tested them for BSE; all were negative. USDA and
the State extensively traced all at-risk cattle and COI that left the index
herd. The majority of these animals entered rendering and/or slaughter
channels well before the
investigation began. USDA's response to the Texas finding was thorough and
effective.
http://www.aphis.usda.gov/lpa/issues/bse/epi-updates/bse_final_epidemiology_report.pdf
Report on Food & Drug Administration Dallas District Investigation of
Bovine Spongiform Encephalopathy Event in Texas 2005
Executive Summary:
On June 24, 2005, USDA informed FDA that a cow in Texas tested positive for
Bovine Spongiform Encephalopathy (BSE). Information provided by APHIS was
that the BSE positive cow was born and raised in a herd in Texas and was
approximately 12 years old. The animal was sampled for BSE at a pet food
plant in Texas on November 15, 2004, as part of USDA's enhanced surveillance
program.
http://www.fda.gov/cvm/texasfeedrpt.htm
Texas even had a 'secret' test that showed that mad cow positive;
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.
http://www.usda.gov/documents/vs_bse_ihctestvar.pdf
48 hr BSE confirmation turnaround took 7+ months to confirm this case, so
the BSE MRR policy could be put into place. ...TSS
THIS highly suspect stumbling and staggering Texas Mad Cow got not test at
all, went straight to render ;
FOR IMMEDIATE RELEASE
Statement
May 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
Statement on Texas Cow With Central Nervous System Symptoms
On Friday, April 30 th , the Food and Drug Administration learned that a cow
with central nervous system symptoms had been killed and shipped to a
processor for rendering into animal protein for use in animal feed.
FDA, which is responsible for the safety of animal feed, immediately began
an investigation. On Friday and throughout the weekend, FDA investigators
inspected the slaughterhouse, the rendering facility, the farm where the
animal came from, and the processor that initially received the cow from the
slaughterhouse.
FDA's investigation showed that the animal in question had already been
rendered into "meat and bone meal" (a type of protein animal feed). Over the
weekend FDA was able to track down all the implicated material. That
material is being held by the firm, which is cooperating fully with FDA.
Cattle with central nervous system symptoms are of particular interest
because cattle with bovine spongiform encephalopathy or BSE, also known as
"mad cow disease," can exhibit such symptoms. In this case, there is no way
now to test for BSE. But even if the cow had BSE, FDA's animal feed rule
would prohibit the feeding of its rendered protein to other ruminant animals
(e.g., cows, goats, sheep, bison).
FDA is sending a letter to the firm summarizing its findings and informing
the firm that FDA will not object to use of this material in swine feed
only. If it is not used in swine feed, this material will be destroyed. Pigs
have been shown not to be susceptible to BSE. If the firm agrees to use the
material for swine feed only, FDA will track the material all the way
through the supply chain from the processor to the farm to ensure that the
feed is properly monitored and used only as feed for pigs.
To protect the U.S. against BSE, FDA works to keep certain mammalian protein
out of animal feed for cattle and other ruminant animals. FDA established
its animal feed rule in 1997 after the BSE epidemic in the U.K. showed that
the disease spreads by feeding infected ruminant protein to cattle.
Under the current regulation, the material from this Texas cow is not
allowed in feed for cattle or other ruminant animals. FDA's action
specifying that the material go only into swine feed means also that it will
not be fed to poultry.
FDA is committed to protecting the U.S. from BSE and collaborates closely
with the U.S. Department of Agriculture on all BSE issues. The animal feed
rule provides crucial protection against the spread of BSE, but it is only
one of several such firewalls. FDA will soon be improving the animal feed
rule, to make this strong system even stronger.
####
http://www.fda.gov/bbs/topics/news/2004/NEW01061.html
OR THE OTHER BSE INCONCLUSIVE THAT SAT ON A SHELF FOR 4 MONTHS WHILE THE
USDA BSE MRR POLICY WAS PUT IN MOTION, simply because this guy forgets to
send sample in, ooops ;
"I would note that the sample was taken in April, at which time the
protocols allowed for a preservative to be used. 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.
http://www.usda.gov/wps/portal/usdahome?contentidonly=true&contentid=2005/07/0280.xml
THE TEXAS GONZALES/PURINA INCIDENT SHOWED THAT 5.5 GRAMS OF
RUMINANT PROTEIN WAS FED TO CATTLE ;
FOR IMMEDIATE RELEASE
P01-05
January 30, 2001
Print Media:
301-827-6242
Broadcast Media:
301-827-3434
Consumer Inquiries:
888-INFO-FDA
FDA ANNOUNCES TEST RESULTS FROM TEXAS FEED LOT
Today the Food and Drug Administration announced the results of tests
taken on feed used at a Texas feedlot
that was suspected of containing meat and bone meal from other domestic
cattle -- a violation of FDA's 1997
prohibition on using ruminant material in feed for other ruminants.
Results indicate that a very low level of
prohibited material was found in the feed fed to cattle.
FDA has determined that each animal could have consumed, at most and in
total, five-and-one-half grams -
approximately a quarter ounce -- of prohibited material. These animals
weigh approximately 600 pounds.
It is important to note that the prohibited material was domestic in
origin (therefore not likely to contain infected
material because there is no evidence of BSE in U.S. cattle), fed at a
very low level, and fed only once. The
potential risk of BSE to such cattle is therefore exceedingly low, even
if the feed were contaminated.
According to Dr. Bernard Schwetz, FDA's Acting Principal Deputy
Commissioner, "The challenge to regulators
and industry is to keep this disease out of the United States. One
important defense is to prohibit the use of any
ruminant animal materials in feed for other ruminant animals. Combined
with other steps, like U.S. Department
of Agriculture's (USDA) ban on the importation of live ruminant animals
from affected countries, these steps
represent a series of protections, to keep American cattle free of BSE."
Despite this negligible risk, Purina Mills, Inc., is nonetheless
announcing that it is voluntarily purchasing all 1,222
of the animals held in Texas and mistakenly fed the animal feed
containing the prohibited material. Therefore,
meat from those animals will not enter the human food supply. FDA
believes any cattle that did not consume
feed containing the prohibited material are unaffected by this incident,
and should be handled in the beef supply
clearance process as usual.
FDA believes that Purina Mills has behaved responsibly by first
reporting the human error that resulted in the
misformulation of the animal feed supplement and then by working closely
with State and Federal authorities.
This episode indicates that the multi-layered safeguard system put into
place is essential for protecting the food
supply and that continued vigilance needs to be taken, by all concerned,
to ensure these rules are followed
routinely.
FDA will continue working with USDA as well as State and local officials
to ensure that companies and
individuals comply with all laws and regulations designed to protect the
U.S. food supply.
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00752.html
From: TSS (216-119-144-34.ipset24.wt.net)
Subject: 1 in 2 CHANCE OF GETTING BSE AKA MAD COW BY THE ORAL ROUTE (PRIMATE
STUDY)
Date: January 27, 2005 at 7:03 am PST
Risk of oral infection with bovine spongiform encephalopathy agent in
primates
Corinne Ida Lasmézas, Emmanuel Comoy, Stephen Hawkins, Christian Herzog,
Franck Mouthon, Timm Konold, Frédéric Auvré, Evelyne Correia, Nathalie
Lescoutra-Etchegaray, Nicole Salès, Gerald Wells, Paul Brown, Jean-Philippe
Deslys
Summary The uncertain extent of human exposure to bovine spongiform
encephalopathy (BSE)--which can lead to variant Creutzfeldt-Jakob disease
(vCJD)--is compounded by incomplete knowledge about the efficiency of oral
infection and the magnitude of any bovine-to-human biological barrier to
transmission. We therefore investigated oral transmission of BSE to
non-human primates. We gave two macaques a 5 g oral dose of brain homogenate
from a BSE-infected cow. One macaque developed vCJD-like neurological
disease 60 months after exposure, whereas the other remained free of disease
at 76 months. On the basis of these findings and data from other studies, we
made a preliminary estimate of the food exposure risk for man, which
provides additional assurance that existing public health measures can
prevent transmission of BSE to man.
BSE bovine brain inoculum
100 g 10 g 5 g 1 g 100 mg 10 mg 1 mg 0·1 mg 0·01 mg
Primate (oral route)* 1/2 (50%)
Cattle (oral route)* 10/10 (100%) 7/9 (78%) 7/10 (70%) 3/15 (20%) 1/15 (7%)
1/15 (7%)
RIII mice (ic ip route)* 17/18 (94%) 15/17 (88%) 1/14 (7%)
PrPres biochemical detection
The comparison is made on the basis of calibration of the bovine inoculum
used in our study with primates against a bovine brain inoculum with a
similar PrPres concentration that was
inoculated into mice and cattle.8 *Data are number of animals
positive/number of animals surviving at the time of clinical onset of
disease in the first positive animal (%). The accuracy of
bioassays is generally judged to be about plus or minus 1 log. ic
ip=intracerebral and intraperitoneal.
Table 1: Comparison of transmission rates in primates and cattle infected
orally with similar BSE brain inocula
Published online January 27, 2005
http://www.thelancet.com/journal/journal.isa
It is clear that the designing scientists must
also have shared Mr Bradley's surprise at the results because all the dose
levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s145d.pdf
2
6. It also appears to me that Mr Bradley's answer (that it would take less
than say 100 grams) was probably given with the benefit of hindsight;
particularly if one
considers that later in the same answer Mr Bradley expresses his surprise
that it could take as little of 1 gram of brain to cause BSE by the oral
route
within the same species. This information did not become available until the
"attack
rate" experiment had been completed in 1995/96. This was a titration
experiment
designed to ascertain the infective dose. A range of dosages was used to
ensure that the actual result was within both a lower and an upper limit
within the
study and the designing scientists would not have expected all the dose
levels to
trigger infection. The dose ranges chosen by the most informed scientists at
that
time ranged from 1 gram to three times one hundred grams. It is clear that
the
designing scientists must have also shared Mr Bradley's surprise at the
results
because all the dose levels right down to 1 gram triggered infection.
http://www.bseinquiry.gov.uk/files/ws/s147f.pdf
10,000,000+ LBS. of PROHIBITED BANNED MAD COW FEED I.E. MBM IN COMMERCE USA
2007
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
Audit Report
Animal and Plant Health Inspection Service
Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II
and
Food Safety and Inspection Service
Controls Over BSE Sampling, Specified Risk Materials, and Advanced Meat
Recovery Products - Phase III
Report No. 50601-10-KC January 2006
Finding 2 Inherent Challenges in Identifying and Testing High-Risk Cattle
Still Remain
Our prior report identified a number of inherent problems in identifying and
testing high-risk cattle. We reported that the challenges in identifying the
universe of high-risk cattle, as well as the need to design procedures to
obtain an appropriate representation of samples, was critical to the success
of the BSE surveillance program. The surveillance program was designed to
target nonambulatory cattle, cattle showing signs of CNS disease (including
cattle testing negative for rabies), cattle showing signs not inconsistent
with BSE, and dead cattle. Although APHIS designed procedures to ensure FSIS
condemned cattle were sampled and made a concerted effort for outreach to
obtain targeted samples, industry practices not considered in the design of
the surveillance program reduced assurance that targeted animals were tested
for BSE.
In our prior report, we recommended that APHIS work with public health and
State diagnostic laboratories to develop and test rabies-negative samples
for BSE. This target group is important for determining the prevalence of
BSE in the United States because rabies cases exhibit clinical signs not
inconsistent with BSE; a negative rabies test means the cause of the
clinical signs has not been diagnosed.
APHIS agreed with our recommendation and initiated an outreach program with
the American Association of Veterinary Laboratory Diagnosticians, as well as
State laboratories. APHIS also agreed to do ongoing monitoring to ensure
samples were obtained from this target population.
Although APHIS increased the samples tested from this target group as
compared to prior years, we found that conflicting APHIS instructions on the
ages of cattle to test resulted in inconsistencies in what samples were
submitted for BSE testing. Therefore, some laboratories did not refer their
rabies negative samples to APHIS in order to maximize the number tested for
this critical target population. In addition, APHIS did not monitor the
number of submissions of rabies negative samples for BSE testing from
specific laboratories.
According to the Procedure Manual for BSE Surveillance, dated October 2004,
the target population includes:
Central nervous system (CNS) signs and/or rabies negative - sample animals
of any age (emphasis added):
a. Diagnostic laboratories –samples submitted due to evidence of CNS
clinical signs.
Rabies Negative Samples
USDA/OIG-A/50601-10-KC Page 19 USDA/OIG-A/50601-10-KC Page 20
b. Public health laboratories – rabies negative cases.
c. Slaughter facilities – CNS ante mortem condemned at slaughter, sampled by
FSIS.
d. On-the-farm – CNS cattle that do not meet the criteria for a foreign
animal disease investigation.
For FYs 2002, 2003, and 2004 (through February 2004), NVSL received 170,
133, and 45 rabies-negative samples, respectively. Between June 1, 2004, and
May 29, 2005, the number of samples received for testing increased to 226
rabies suspect samples. The collection sites submitting these samples
follow.
Number of Rabies
Suspect Submissions *
Slaughter Plant
0
Renderer
2
On-Farm
11
Public Health Lab
94
Diagnostic Lab
81
3D-4D
8
Other
4
Collection Site
Total
200
* 26 were tested but not counted by APHIS towards meeting the target goals
because the obex was not submitted.
We obtained a copy of a memorandum, dated July 13, 2004, that APHIS sent to
diagnostic and public health laboratories providing them instructions on
submitting samples for cattle showing signs of CNS diseases, but testing
negative for rabies. The letter was sent to about 170 State veterinary
diagnostic and public health laboratories and discussed the need to submit
specimens to NVSL of all adult cattle (emphasis added) that showed signs of
CNS diseases, but tested negative for rabies. This directive did not specify
the age of the cattle. The Procedure Manual for BSE Surveillance, dated
October 2004, specified samples of cattle of any age should be submitted.
We contacted laboratories in six States to determine if it was standard
procedure to submit all negative rabies samples to NVSL. We found that,
because of the lack of specificity in the APHIS letter and inadequate
followup by APHIS, there were inconsistencies in the age of cattle samples
submitted for BSE testing. For those States contacted, the following samples
were submitted versus tested as negative for rabies.
USDA/OIG-A/50601-10-KC Page 21
Rabies Negative Tests Not Sent for BSE Testing Since June 1, 2004
State
Negative Rabies Tests
Not Sent for BSE Testing
Pennsylvania a/
15
18
Kansas b/
69
16
Wisconsin c/
1
11
South Dakota d/
0
7
Arizona e/
5
0
Mississippi e/
4
0
Total
Sent for BSE Testing
33
85
12
7
5
4
146
94
52
a/ A Pennsylvania laboratory official said only rabies negative cattle over
20 months of age were submitted for BSE testing. The laboratory did not
submit 18 samples for BSE testing because the animals were less than 20
months of age.
b/ Kansas laboratory officials said early in the expanded surveillance
program, there was confusion as to the cattle ages that should be submitted
for BSE testing. They did not know if cattle should be submitted that were
above 20 months or 30 months of age. Of the 16 animals not submitted for BSE
testing, 14 were under 20 months of age from early in the expanded
surveillance program. The other two animals were not tested due to internal
laboratory issues. The Kansas and Nebraska area office officials contacted
the laboratory and told the officials to submit rabies negative cattle of
any age for BSE testing. The laboratory now submits all rabies negative
cattle for BSE testing.
c/ A Wisconsin laboratory official said only rabies negative cattle samples
30 months of age or older are submitted for BSE testing. Of the 11 animals
not submitted for BSE testing, 8 were less than 30 months of age. Wisconsin
laboratory officials were not certain why the other three samples were not
submitted.
d/ Laboratory officials from South Dakota said they did not receive
notification from APHIS regarding the submission of rabies negative cases
for BSE testing. The section supervisor and laboratory director were not
aware of any letter sent to the laboratory. The section supervisor said most
bovine rabies tests at the laboratory are performed on calves. We confirmed
the laboratory's address matched the address on APHIS' letter distribution
list. However, there was no evidence that the South Dakota area office
contacted the laboratory. The laboratory was not listed on the documentation
from the APHIS regional office detailing the area office contacts with
laboratory personnel. We contacted the South Dakota area office and were
advised that while some contact had been made with the laboratory, the
contact may have involved Brucellosis rather than BSE. On May 4, 2005, the
area office
33 Report from the Secretary's Advisory Committee on Foreign Animal and
Poultry Diseases, February 13, 2004.
advised us they recently contacted the laboratory regarding the submission
of rabies negative samples for BSE testing.
e/ Arizona and Mississippi laboratory officials said they submitted all
rabies negative samples for BSE testing regardless of the age of the animal.
An NVSL official stated that APHIS is not concerned with rabies negatives
samples from cattle less than 30 months of age. This position, however, is
contrary to APHIS' published target population.
Our prior audit recognized the significant challenge for APHIS to obtain
samples from some high-risk populations because of the inherent problems
with obtaining voluntary compliance and transporting the carcasses for
testing. USDA issued rules to prohibit nonambulatory animals (downers) from
entering the food supply at inspected slaughterhouses. OIG recommended, and
the International Review Subcommittee33 emphasized, that USDA should take
additional steps to assure that facilitated pathways exist for dead and
nonambulatory cattle to allow for the collection of samples and proper
disposal of carcasses. Between June 1, 2004, and May 31, 2005, the APHIS
database documents 27,617 samples were collected showing a reason for
submission of nonambulatory and 325,225 samples were collected with reason
of submission showing "dead."
APHIS made extensive outreach efforts to notify producers and private
veterinarians of the need to submit and have tested animals from these
target groups. They also entered into financial arrangements with 123
renderers and other collection sites to reimburse them for costs associated
with storing, transporting, and collecting samples. However, as shown in
exhibit F, APHIS was not always successful in establishing agreements with
non-slaughter collection sites in some States. APHIS stated that agreements
do not necessarily reflect the entire universe of collection sites and that
the presentation in exhibit F was incomplete because there were many
collection sites without a payment involved or without a formal agreement.
We note that over 90 percent of the samples collected were obtained from the
123 collection sites with agreements and; therefore, we believe agreements
offer the best source to increase targeted samples in underrepresented
areas.
We found that APHIS did not consider industry practices in the design of its
surveillance effort to provide reasonable assurance that cattle exhibiting
possible clinical signs consistent with BSE were tested. Slaughter
facilities do not always accept all cattle arriving for slaughter because of
their business requirements. We found that, in one State visited, slaughter
facilities pre-screened and rejected cattle (sick/down/dead/others not
meeting business
Downers and Cattle that Died on the Farm
USDA/OIG-A/50601-10-KC Page 22 USDA/OIG-A/50601-10-KC Page 23
34 FSIS regulations do not specifically address the designation of an
establishment's "official" boundaries; however, FSIS Notices 29-04 (dated
May 27, 2004) and 40-04 (dated July 29, 2004) make it clear that FSIS
inspection staff are not responsible for sampling dead cattle that are not
part of the "official" premises.
35 APHIS' area office personnel stated that it was their understanding that
some establishments in the State were not presenting cattle that died or
were down on the transport vehicle to FSIS for ante mortem inspection. The
dead and down cattle were left in the vehicle, if possible. In rare
circumstances, dead cattle may be removed from the trailer by plant
personnel to facilitate the unloading of other animals.
36 A May 20, 2004, Memorandum between the Administrators of APHIS and FSIS.
standards) before presentation for slaughter in areas immediately adjacent
or contiguous to the official slaughter establishment. These animals were
not inspected and/or observed by either FSIS or APHIS officials located at
the slaughter facilities.
FSIS procedures state that they have no authority to inspect cattle not
presented for slaughter. Further, APHIS officials stated they did not
believe that they had the authority to go into these sorting and/or
screening areas and require that the rejected animals be provided to APHIS
for BSE sampling. Neither APHIS nor FSIS had any process to assure that
animals left on transport vehicles and/or rejected for slaughter arrived at
a collection site for BSE testing. FSIS allows slaughter facilities to
designate the area of their establishment where federal inspection is
performed; this is designated as the official slaughter establishment.34
We observed animals that were down or dead in pens outside the official
premises that were to be picked up by renderers. Animals that were rejected
by plant personnel were transported off the premises on the same vehicles
that brought them to the plant.35
A policy statement36 regarding BSE sampling of condemned cattle at slaughter
plants provided that effective June 1, 2004, FSIS would collect BSE samples
for testing: 1) from all cattle regardless of age condemned by FSIS upon
ante mortem inspection for CNS impairment, and 2) from all cattle, with the
exception of veal calves, condemned by FSIS upon ante mortem inspection for
any other reason.
FSIS Notice 28-04, dated May 20, 2004, informed FSIS personnel that, "FSIS
will be collecting brain samples from cattle at federally-inspected
establishments for the purpose of BSE testing." The notice further states
that, "Cattle off-loaded from the transport vehicle onto the premises of the
federally-inspected establishment (emphasis added), whether dead or alive,
will be sampled by the FSIS Public Health Veterinarian (PHV) for BSE after
the cattle have been condemned during ante mortem inspection. In addition,
cattle passing ante mortem inspection but later found dead prior to
slaughter will be condemned and be sampled by the FSIS PHV."
USDA/OIG-A/50601-10-KC Page 24
37 FSIS Notice 40-04, dated July 29, 2004.
38 FSIS Notice 29-04, dated May 27, 2004.
APHIS has the responsibility for sampling dead cattle off-loaded onto
plant-owned property that is adjoining to, but not considered part of, the
"official premises.37 FSIS procedures38 provide that "Dead cattle that are
off-loaded to facilitate the off-loading of live animals, but that will be
re-loaded onto the transport vehicle, are not subject to sampling by FSIS.
While performing our review in one State, we reviewed the circumstances at
two slaughter facilities in the State that inspected and rejected unsuitable
cattle before the animals entered the official receiving areas of the
plants. This pre-screening activity was conducted in areas not designated by
the facility as official premises of the establishment and not under the
review or supervision of FSIS inspectors. The plant rejected all
nonambulatory and dead/dying/sick animals delivered to the establishment.
Plant personnel refused to offload any dead or downer animals to facilitate
the offloading of ambulatory animals. Plant personnel said that the driver
was responsible for ensuring nonambulatory animals were humanely euthanized
and disposing of the carcasses of the dead animals. Plant personnel informed
us that they did not want to jeopardize contracts with business partners by
allowing unsuitable animals on their slaughter premises.
In the second case, one family member owned a slaughter facility while
another operated a livestock sale barn adjacent to the slaughter facility.
The slaughter facility was under FSIS' supervision while the sale barn was
not. Cattle sometimes arrived at the sale barn that were sick/down/dead or
would die or go down while at the sale barn. According to personnel at the
sale barn, these animals were left for the renderer to collect. The healthy
ambulatory animals that remained were marketed to many buyers including the
adjacent slaughter facility. When the slaughter facility was ready to accept
the ambulatory animals for processing, the cattle would be moved from the
sale barn to the slaughter facility where they were subject to FSIS'
inspection.
We requested the slaughter facilities to estimate the number of cattle
rejected on a daily basis (there were no records to confirm the estimates).
We visited a renderer in the area and found that the renderer had a contract
with APHIS to collect samples for BSE testing. In this case, although we
could not obtain assurance that all rejected cattle were sampled, the
renderer processed a significant number of animals, as compared to the
slaughter plants' estimates of those rejected. Due to the close proximity
(less than 5 miles) of the renderer to the slaughter facilities, and the
premium it paid for dead cattle that were in good condition, there was a
financial incentive for transport drivers to dispose of their dead animals
at this renderer.
USDA/OIG-A/50601-10-KC Page 25
In our discussions with APHIS officials in Wisconsin and Iowa, they
confirmed that there were plants in their States that also used
pre-screening practices. On May 27, 2005, we requested APHIS and FSIS to
provide a list of all slaughter facilities that pre-screened cattle for
slaughter in locations away from the area designated as the official
slaughter facility. Along with this request, we asked for information to
demonstrate that either APHIS or FSIS confirmed there was a high likelihood
that high-risk animals were sampled at other collection sites.
In response to our request, the APHIS BSE Program Manager stated that APHIS
did not have information on slaughter plants that pre-screen or screen their
animals for slaughter suitability off their official plant premises. To
their knowledge, every company or producer that submits animals for
slaughter pre-sorts or screens them for suitability at various locations
away from the slaughter facility. For this reason, USDA focused its BSE
sample collection efforts at other types of facilities such as renderers,
pet food companies, landfills, and dead stock haulers. Further, in a letter
to OIG on June 14, 2005, the administrators of APHIS and FSIS noted the
following:
"…we believe that no specific actions are necessary or appropriate to obtain
reasonable assurance that animals not presented for slaughter are being
tested for BSE. There are several reasons for our position. First, we do not
believe that the practice is in fact causing us to not test a significant
enough number of animals in our enhanced surveillance program to invalidate
the overall results. Second, OIG has concluded that because of the
geographical proximity and business relationships of the various entities
involved in the case investigated, there is reasonable assurance that a
majority of the rejected cattle had been sampled. Third, it is also
important to remember that the goal of the enhanced surveillance program is
to test a sufficient number of animals to allow us to draw conclusions about
the level of BSE (if any) in the American herd…We believe that the number we
may be not testing because of the "pre-sorting" practice does not rise to a
significant level. The number of animals tested to date has far exceeded
expectations, so it is reasonable to infer that there are few of the animals
in question, or that we are testing them at some other point in the
process…APHIS estimated…there were approximately 446,000 high risk
cattle…[and APHIS has]…tested over 375,000 animals in less than 1 year. This
indicated that we are missing few animals in the high-risk population,
including those that might be pre-sorted before entering a slaughter
facility's property."
We obtained 123 APHIS sampling agreements and contracts with firms and
plotted their locations within the United States (see exhibit F). We also
analyzed the samples tested to the BSE sampling goals allocated to each
State under the prior surveillance program. This analysis showed that there
are
USDA/OIG-A/50601-10-KC Page 26
39APHIS noted that sites with agreements do not necessarily reflect the
entire universe of collection sites and at some sites APHIS collects samples
with no payment involved and no agreement in place. OIG agrees that not all
collection sites are reflected in our presentation of the 123 sites with
reimbursable agreements. OIG believes obtaining sampling agreements is one
of the primary methods available to increase sample numbers in areas with
sampling gaps.
sampling gaps in two large areas of the United States where APHIS did not
have contracts with collection sites. These two areas are shown in the
following chart (Montana, South Dakota, North Dakota and Wyoming – Group 1
and Louisiana, Oklahoma, Arkansas, and Tennessee – Group 2):
State
Original Sampling Goal Based on (268,500 sampling goal)
Samples collected as of May 31, 2005
No. of BSE Sampling Agreements/
Contracts39
snip...see chart in pdf full text link. ...tss
APHIS notes that for the current surveillance program, it had established
regional goals and APHIS was not trying to meet particular sampling levels
in particular States. However, we believe that it would be advantageous for
APHIS to monitor collection data and increase outreach when large
geographical areas such as the above States do not provide samples in
proportion to the numbers and types of cattle in the population.
We also disagree with APHIS/FSIS' contention that because they have tested
over 375,000 of their 446,000 estimate of high risk cattle, few in the
high-risk population are being missed, including those that might be
pre-screened before entering a slaughter facility's property. In our prior
audit, we reported that APHIS underestimated the high-risk population; we
found that this estimate should have been closer to 1 million animals (see
Finding 1). We recognize that BSE samples are provided on a voluntary basis;
however, APHIS should consider industry practice in any further maintenance
surveillance effort. Animals unsuitable for slaughter exhibiting symptoms
not inconsistent with BSE should be sampled and their clinical signs
recorded. However, this cited industry practice results in rejected animals
not being made available to either APHIS or FSIS veterinarians for their
observation and identification of clinical signs exhibited ante mortem.
Although these animals may be sampled later at other collection sites, the
animals are provided post mortem without information as to relevant clinical
signs exhibited ante mortem. For these reasons, we believe APHIS needs to
USDA/OIG-A/50601-10-KC Page 27
observe these animals ante mortem when possible to assure the animals from
the target population are ultimately sampled and the clinical signs
evaluated.
snip...
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 infect
