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From: TSS ()
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


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.”


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.

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
APHIS (Animal and Plant Health Inspection Service) (2006b). Summary of BSE
Surveillance in the United States. USDA: APHIS: VS: Centers for Epidemiology
and Animal Health,
National Surveillance Unit. Accessed May 5, 2006, online at
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
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:
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.

does not compute. fuzzy math. full formula below. ...TSS


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


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,

RELEASE NUMBER: 2007-051(Farabee)
# # #

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:

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

> -------- Original Message --------
> Date: Fri, 17 Dec 2004 15:37:28 -0600
> From: "Terry S. Singeltary Sr."
> To:
> 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


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

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
said something about ''just look at the sheep that tested IHC- but were
positive''. ...


-------- Original Message --------
Subject: Your questions
Date: Mon, 27 Dec 2004 15:58:11 -0800
From: To:

Hi Terry:

............................................snip Let me know your phone
number so I can talk to you about the Bio-Rad BSE test.
Thank you


Bio-Rad Laboratories
2000 Alfred Nobel Drive
Hercules, CA 94547
Ph: 510-741-6720
Fax: 510-741-5630
Email: =================================


######### ##########

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.

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

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


• A Western blot test conducted the week of

June 5, 2005, returned positive for BSE.

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 ;

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

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.



"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.


January 30, 2001
Print Media:
Broadcast Media:
Consumer Inquiries:


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

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.

From: TSS (
Date: January 27, 2005 at 7:03 am PST

Risk of oral infection with bovine spongiform encephalopathy agent in

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
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

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.


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.


Date: March 21, 2007 at 2:27 pm PST
Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried,
Recall # V-024-2007
Cattle feed delivered between 01/12/2007 and 01/26/2007
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007.
Firm initiated recall is ongoing.
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
42,090 lbs.

Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL
Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal,
A-BYPASS ML W/SMARTA, Recall # V-025-2007
The firm does not utilize a code - only shipping documentation with
commodity and weights identified.
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm
initiated recall is complete.
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.
9,997,976 lbs.
ID and NV


Audit Report

Animal and Plant Health Inspection Service

Bovine Spongiform Encephalopathy (BSE) Surveillance Program – Phase II


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

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

Number of Rabies
Suspect Submissions *

Slaughter Plant



Public Health Lab

Diagnostic Lab



Collection Site



* 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
Negative Rabies Tests

Not Sent for BSE Testing
Pennsylvania a/

Kansas b/

Wisconsin c/

South Dakota d/

Arizona e/

Mississippi e/


Sent for BSE Testing










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

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

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’

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

"…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

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):

Original Sampling Goal Based on (268,500 sampling goal)

Samples collected as of May 31, 2005

No. of BSE Sampling Agreements/
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


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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

Suppressed PEER REVIEW of the Harvard BSE study
of October 31, 2002


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

[Docket No. 03-025IFA] FSIS Prohibition of the Use of Specified Risk
Materials for Human Food and Requirement for the Disposition of
Non-Ambulatory Disabled Cattle

Terry S. Singeltary


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

Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Comment Number: EC -10

Accepted - Volume 2


Date: Thu, 1 Mar 2007 14:57:20 -0600
Reply-To: Sustainable Agriculture Network Discussion Group
Sender: Sustainable Agriculture Network Discussion Group
From: "Terry S. Singeltary Sr." <[log in to unmask]>

THE OIE has now shown they are nothing more than a National Trading Brokerage for all strains of animal TSE.

AS i said before, OIE should hang up there jock strap now, since it appears they will buckle every time a country

makes some political hay about trade protocol, commodities and futures. IF they are not going to be science based, they

should do everyone a favor and dissolve there organization. ...

Page 95 of 98




see full text ;

IT'S as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the

USDA/APHIS/FSIS/FDA/CDC/NIH et al for many many years, or the incompetence of these agencies are so inept,

either through ignorance and or just too overweight with industry reps., they then should be all done away with and a

single agency brought forth, and if not, how will you correct this ongoing problem ?

GWs and his sleeping partners at the OIE, gave birth to the BSE MRR policy, the legal. trading of all strains of TSE globally ...


(Adopted by the International Committee of the OIE on 23 May 2006)

11. Information published by the OIE is derived from appropriate declarations made by the
official Veterinary Services of Member Countries. The OIE is not responsible for inaccurate
publication of country disease status based on inaccurate information or changes in
epidemiological status or other significant events that were not promptly reported to the
Central Bureau,

AS I SAID, bought and paid for by your local cattle dealer i.e. USDA. The status of USA for BSE that is to be announced in May 2007 by OIE, has already been decided, and it's a big fat lie. This is like letting a known, and convicted criminal, prosecute themselves. They will find themselves innocent every time. It's a win/win situation for the industry, and the consumer cr@ps out again, snake eyes, you loose. ...

Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518

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